[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

(c) Circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application also include the following circumstances, which will result in the following reduction of the period of adjustment set forth in § 1.703 to the extent that the periods are not overlapping:

• (1) Suspension of action under § 1.103 at the applicant’s request, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for suspension of action under § 1.103 was filed and ending on the date of the termination of the suspension;
• (2) Deferral of issuance of a patent under § 1.314, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under § 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued;
• (3) Abandonment of the application or late payment of the issue fee, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed;
• (4) Failure to file a petition to withdraw the holding of abandonment or to revive an application within two months from the date of mailing of a notice of abandonment, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date two months from the date of mailing of a notice of abandonment and ending on the date a petition to withdraw the holding of abandonment or to revive the application was filed;
• (5) Conversion of a provisional application under 35 U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 111(a) pursuant to 35 U.S.C. 111(b)(5), in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the date the application was filed under 35 U.S.C. 111(b) and ending on the date a request in compliance with § 1.53(c)(3) to convert the provisional application into a nonprovisional application was filed;
• (6) Submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed;
• (7) Submission of a reply having an omission (§ 1.135(c)), in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed;
• (8) Submission of a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the examiner, after a reply has been filed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or other such paper was filed;
• (9) Submission of an amendment or other paper after a decision by the Patent Trial and Appeal Board, other than a decision designated as containing a new ground of rejection under § 41.50(b) of this title or statement under § 41.50(c) of this title, or a decision by a Federal court, less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or supplemental notice of allowance, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a Federal court and ending on date the amendment or other paper was filed;
• (10) Submission of an amendment under § 1.312 or other paper, other than an amendment under § 1.312 or other paper expressly requested by the Office or a request for continued examination in compliance with § 1.114, after a notice of allowance has been given or mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed;
• (11) Failure to file an appeal brief in compliance with § 41.37 of this chapter within three months from the date on which a notice of appeal to the Patent Trial and Appeal Board was filed under 35 U.S.C. 134 and § 41.31 of this chapter, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date three months from the date on which a notice of appeal to the Patent Trial and Appeal Board was filed under 35 U.S.C. 134 and § 41.31 of this chapter, and ending on the date an appeal brief in compliance with § 41.37 of this chapter or a request for continued examination in compliance with § 1.114 was filed;
• (12) Submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed;
• (13) Failure to provide an application in condition for examination as defined in paragraph (f) of this section within eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the application is in condition for examination as defined in paragraph (f) of this section; and
• (14) Further prosecution via a continuing application, in which case the period of adjustment set forth in § 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent.

(e) The submission of a request under § 1.705(c) for reinstatement of reduced patent term adjustment will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under paragraph (c)(10) of this section.

37 CFR 1.704 implements the provisions of 35 U.S.C. 154(b)(2)(C) which provides that the period of patent term adjustment under 35 U.S.C. 154(b)(1) “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application,” and specifies certain circumstances as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Further, 35 U.S.C. 154(b)(2)(C)(iii) gives the Office the authority to prescribe regulations establishing circumstances that constitute “a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C) does not require the applicant’s action or inaction (that amounts to a failure to engage in reasonable efforts to conclude prosecution of the application) to have caused or contributed to patent term adjustment for the period of adjustment to be reduced due to such action or inaction. The patent term adjustment provisions of 35 U.S.C. 154(b) create a balanced system allowing for patent term adjustment due to Office delays for a reasonably diligent applicant. Since the public has an interest in the technology disclosed and covered by a patent being available to the public at the earliest possible date, 35 U.S.C. 154(b)(2)(C)(i) provides that patent term adjustment is reduced by any period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application, regardless of whether the applicant’s actions or inactions caused or contributed to patent term adjustment.

37 CFR 1.704 implements the provisions of 35 U.S.C. 154(b)(2)(C) which provides that the period of patent term adjustment under 35 U.S.C. 154(b)(1) “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application,” and specifies certain circumstances as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Further, 35 U.S.C. 154(b)(2)(C)(iii) gives the Office the authority to prescribe regulations establishing circumstances that constitute “a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C) does not require the applicant’s action or inaction (that amounts to a failure to engage in reasonable efforts to conclude prosecution of the application) to have caused or contributed to patent term adjustment for the period of adjustment to be reduced due to such action or inaction. The patent term adjustment provisions of 35 U.S.C. 154(b) create a balanced system allowing for patent term adjustment due to Office delays for a reasonably diligent applicant. Since the public has an interest in the technology disclosed and covered by a patent being available to the public at the earliest possible date, 35 U.S.C. 154(b)(2)(C)(i) provides that patent term adjustment is reduced by any period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application, regardless of whether the applicant’s actions or inactions caused or contributed to patent term adjustment.

37 CFR 1.704(a) implements the provisions of 35 U.S.C. 154(b)(2)(C)(i) and sets forth that the period of adjustment shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (i.e., processing or examination) of an application.

The three-month period in 37 CFR 1.704(b) applies to the Office notices and letters issued as part of the pre-examination processing of an application (except a Notice of Omitted Items in a Nonprovisional Application as discussed above). These notices include: (1) a Notice of Incomplete Nonprovisional Application (except as to any period prior to the filing date ultimately accorded to the application); (2) a Notice to File Missing Parts of Non-Provisional Application; (3) an Informational Notice to Applicant; (4) a Notice to File Corrected Application Papers Filing Date Granted; or (5) a Notice to Comply with Requirements for Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures.

37 CFR 1.704(c) establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. 37 CFR 1.704(c)(1) through (c)(13) set forth actions or inactions by an applicant that interfere with the Office’s ability to process or examine an application (and, thus, are circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application), as well as the period by which a period of adjustment set forth in 37 CFR 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. 37 CFR 1.704(c) requires that an applicant refrain from engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application. An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as “engag[ing] in reasonable efforts to conclude processing or examination of an application” (35 U.S.C. 154(b)(2)(C)(i)). A reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 129 USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c) establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. 37 CFR 1.704(c)(1) through (c)(13) set forth actions or inactions by an applicant that interfere with the Office’s ability to process or examine an application (and, thus, are circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application), as well as the period by which a period of adjustment set forth in 37 CFR 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. 37 CFR 1.704(c) requires that an applicant refrain from engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application. An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as “engag[ing] in reasonable efforts to conclude processing or examination of an application” (35 U.S.C. 154(b)(2)(C)(i)). A reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 129 USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c) establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. 37 CFR 1.704(c)(1) through (c)(13) set forth actions or inactions by an applicant that interfere with the Office’s ability to process or examine an application (and, thus, are circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application), as well as the period by which a period of adjustment set forth in 37 CFR 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. 37 CFR 1.704(c) requires that an applicant refrain from engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application. An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as “engag[ing] in reasonable efforts to conclude processing or examination of an application” (35 U.S.C. 154(b)(2)(C)(i)). A reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 129 USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c) establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. 37 CFR 1.704(c)(1) through (c)(13) set forth actions or inactions by an applicant that interfere with the Office’s ability to process or examine an application (and, thus, are circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application), as well as the period by which a period of adjustment set forth in 37 CFR 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. 37 CFR 1.704(c) requires that an applicant refrain from engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application. An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as “engag[ing] in reasonable efforts to conclude processing or examination of an application” (35 U.S.C. 154(b)(2)(C)(i)). A reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 129 USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c) establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. 37 CFR 1.704(c)(1) through (c)(13) set forth actions or inactions by an applicant that interfere with the Office’s ability to process or examine an application (and, thus, are circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application), as well as the period by which a period of adjustment set forth in 37 CFR 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. 37 CFR 1.704(c) requires that an applicant refrain from engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application. An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as “engag[ing] in reasonable efforts to conclude processing or examination of an application” (35 U.S.C. 154(b)(2)(C)(i)). A reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 129 USPQ2d 1240 (Fed. Cir. 2019).

37 CFR 1.704(c)(1) through 1.704(c)(14) address situations that occur with sufficient frequency to warrant being specifically provided for in the rules of practice. These situations do not represent an exhaustive list of actions or inactions that interfere with the Office’s ability to process or examine an application, since there are a myriad of actions or inactions that occur infrequently but will interfere with the Office’s ability to process or examine an application (e.g., applicant files and persists in requesting reconsideration of a meritless petition under 37 CFR 1.10; parties to an interference obtain an extension for purposes of settlement negotiations which do not result in settlement of the interference; and when the scope of the broadest claim in the application at the time an application is placed in condition for allowance is substantially the same as suggested or allowed by the examiner more than six months earlier than the date the application was placed in condition for allowance). Thus, the actions or inactions set forth in 37 CFR 1.704(c) are exemplary circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The Office may also reduce a period of adjustment provided in 37 CFR 1.703 on the basis of conduct that interferes with the Office’s ability to process or examine an application under the authority provided in 35 U.S.C. 154(b)(2)(C)(iii), even if such conduct is not specifically addressed in 37 CFR 1.704(c).

Effective for applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10) were substantively amended in the final rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 85 FR 36335 (June 16, 2020). These paragraphs, as amended, were revised to state the period of reduction is equal to “the period from the beginning to the end of the applicant’s failure to engage in reasonable efforts to conclude prosecution” and that the reduction cannot exceed the period of time during which an applicant failed to engage in reasonable efforts. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019). The Office will decide any timely request for reconsideration in compliance with 37 CFR 1.705(b) of a patent term adjustment determination in applications or patents eligible for patent term adjustment in which a notice of allowance mailed prior to July 16, 2020, consistent with the changes in the final rule, as discussed below, if requested by the patentee.

Effective for applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10) were substantively amended in the final rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 85 FR 36335 (June 16, 2020). These paragraphs, as amended, were revised to state the period of reduction is equal to “the period from the beginning to the end of the applicant’s failure to engage in reasonable efforts to conclude prosecution” and that the reduction cannot exceed the period of time during which an applicant failed to engage in reasonable efforts. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019). The Office will decide any timely request for reconsideration in compliance with 37 CFR 1.705(b) of a patent term adjustment determination in applications or patents eligible for patent term adjustment in which a notice of allowance mailed prior to July 16, 2020, consistent with the changes in the final rule, as discussed below, if requested by the patentee.

Effective for applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10) were substantively amended in the final rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 85 FR 36335 (June 16, 2020). These paragraphs, as amended, were revised to state the period of reduction is equal to “the period from the beginning to the end of the applicant’s failure to engage in reasonable efforts to conclude prosecution” and that the reduction cannot exceed the period of time during which an applicant failed to engage in reasonable efforts. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019). The Office will decide any timely request for reconsideration in compliance with 37 CFR 1.705(b) of a patent term adjustment determination in applications or patents eligible for patent term adjustment in which a notice of allowance mailed prior to July 16, 2020, consistent with the changes in the final rule, as discussed below, if requested by the patentee.

37 CFR 1.704(c)(1) establishes suspension of action under 37 CFR 1.103 at the applicant’s request as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if action is suspended at the applicant’s request, the Office is precluded from processing or examining the application as a result of an action by the applicant. 37 CFR 1.704(c)(1) also provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for suspension of action under 37 CFR 1.103 was filed and ending on the date of the termination of the suspension.

37 CFR 1.704(c)(1) establishes suspension of action under 37 CFR 1.103 at the applicant’s request as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if action is suspended at the applicant’s request, the Office is precluded from processing or examining the application as a result of an action by the applicant. 37 CFR 1.704(c)(1) also provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for suspension of action under 37 CFR 1.103 was filed and ending on the date of the termination of the suspension.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(4) establishes failure to file a petition to withdraw a holding of abandonment or to revive an application within two months from the date of mailing of a notice of abandonment as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Any applicant who considers an application to have been improperly held abandoned (the reduction in 37 CFR 1.704(c)(3) is applicable to the revival of an application properly held abandoned) is expected to file a petition to withdraw the holding of abandonment (or to revive the application) within two months from the date of mailing of a notice of abandonment. See MPEP § 711.03(c), subsection I. 37 CFR 1.704(c)(4) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date two months from the date of mailing of a notice of abandonment and ending on the date a petition to withdraw the holding of abandonment or to revive the application was filed.

37 CFR 1.704(c)(4) establishes failure to file a petition to withdraw a holding of abandonment or to revive an application within two months from the date of mailing of a notice of abandonment as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Any applicant who considers an application to have been improperly held abandoned (the reduction in 37 CFR 1.704(c)(3) is applicable to the revival of an application properly held abandoned) is expected to file a petition to withdraw the holding of abandonment (or to revive the application) within two months from the date of mailing of a notice of abandonment. See MPEP § 711.03(c), subsection I. 37 CFR 1.704(c)(4) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date two months from the date of mailing of a notice of abandonment and ending on the date a petition to withdraw the holding of abandonment or to revive the application was filed.

If a petition to withdraw the holding of abandonment is granted, the Office’s OPSG system records should be checked to ensure that the correct term adjustment determination is made. Applicants are encouraged to check the Office’s OPSG system records for their applications through the USPTO patent electronic filing system (see MPEP § 2733). For example, if applicant shows in the petition that a reply was filed in the Office on March 2, but the March 2 reply was never matched with the file, when the petition to withdraw the holding of abandonment is granted, the receipt of a paper on March 2 should be recorded on the Office’s OPSG system records. If the papers or dates are recorded incorrectly, applicant should contact the examiner, the examiner’s supervisor or the Technology Center customer service representative to have the entry corrected. If an applicant receives a Notice of Abandonment and does not request that the holding of abandonment be withdrawn within two months of the date of mailing of the notice, the applicant has failed to engage in reasonable efforts to conclude prosecution and any patent term adjustment will be reduced pursuant to 37 CFR 1.704(c)(4).

If a petition to withdraw the holding of abandonment is granted, the Office’s OPSG system records should be checked to ensure that the correct term adjustment determination is made. Applicants are encouraged to check the Office’s OPSG system records for their applications through the USPTO patent electronic filing system (see MPEP § 2733). For example, if applicant shows in the petition that a reply was filed in the Office on March 2, but the March 2 reply was never matched with the file, when the petition to withdraw the holding of abandonment is granted, the receipt of a paper on March 2 should be recorded on the Office’s OPSG system records. If the papers or dates are recorded incorrectly, applicant should contact the examiner, the examiner’s supervisor or the Technology Center customer service representative to have the entry corrected. If an applicant receives a Notice of Abandonment and does not request that the holding of abandonment be withdrawn within two months of the date of mailing of the notice, the applicant has failed to engage in reasonable efforts to conclude prosecution and any patent term adjustment will be reduced pursuant to 37 CFR 1.704(c)(4).

If a petition to withdraw the holding of abandonment is granted, the Office’s OPSG system records should be checked to ensure that the correct term adjustment determination is made. Applicants are encouraged to check the Office’s OPSG system records for their applications through the USPTO patent electronic filing system (see MPEP § 2733). For example, if applicant shows in the petition that a reply was filed in the Office on March 2, but the March 2 reply was never matched with the file, when the petition to withdraw the holding of abandonment is granted, the receipt of a paper on March 2 should be recorded on the Office’s OPSG system records. If the papers or dates are recorded incorrectly, applicant should contact the examiner, the examiner’s supervisor or the Technology Center customer service representative to have the entry corrected. If an applicant receives a Notice of Abandonment and does not request that the holding of abandonment be withdrawn within two months of the date of mailing of the notice, the applicant has failed to engage in reasonable efforts to conclude prosecution and any patent term adjustment will be reduced pursuant to 37 CFR 1.704(c)(4).

If a petition to withdraw the holding of abandonment is granted, the Office’s OPSG system records should be checked to ensure that the correct term adjustment determination is made. Applicants are encouraged to check the Office’s OPSG system records for their applications through the USPTO patent electronic filing system (see MPEP § 2733). For example, if applicant shows in the petition that a reply was filed in the Office on March 2, but the March 2 reply was never matched with the file, when the petition to withdraw the holding of abandonment is granted, the receipt of a paper on March 2 should be recorded on the Office’s OPSG system records. If the papers or dates are recorded incorrectly, applicant should contact the examiner, the examiner’s supervisor or the Technology Center customer service representative to have the entry corrected. If an applicant receives a Notice of Abandonment and does not request that the holding of abandonment be withdrawn within two months of the date of mailing of the notice, the applicant has failed to engage in reasonable efforts to conclude prosecution and any patent term adjustment will be reduced pursuant to 37 CFR 1.704(c)(4).

37 CFR 1.704(c)(6) establishes submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. If the submission of a preliminary amendment or other paper requires the Office to issue a supplemental Office action or notice of allowance, the submission of that preliminary amendment or other paper has interfered with the processing and examination of an application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(6) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance or four months. The phrase “lesser of… or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(6) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance.

37 CFR 1.704(c)(7) establishes submission of a reply having an omission (e.g., 37 CFR 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under 37 CFR 1.135(c) and await and process the applicant’s reply to the action under 37 CFR 1.135(c) before the initial reply (as corrected) can be treated on its merits. In addition, 37 CFR 1.704(c)(7) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed. The reference to 37 CFR 1.135(c) is parenthetical because 37 CFR 1.704(c)(7) is not limited to Office actions under 37 CFR 1.135(c) but applies also when the Office issues any action or notice indicating that a reply has an omission which must be corrected: for example, (1) a decision on a petition under 37 CFR 1.47 dismissing the petition as lacking an item necessary to grant the petition; or (2) a notice indicating that the computer readable sequence listing submitted in an application filed on or after July 1, 2022, in reply to a previous notice relating to the requirements for patent applications containing nucleotide and/or amino acid sequence disclosures, does not comply with 37 CFR 1.831 et seq. The filing of a non-compliant appeal brief, however, will not be deemed an omission under 37 CFR 1.704(c)(7) if the notice of appeal was filed on or after September 17, 2012. This situation is covered under 37 CFR 1.704(c)(11).

37 CFR 1.704(c)(7) establishes submission of a reply having an omission (e.g., 37 CFR 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under 37 CFR 1.135(c) and await and process the applicant’s reply to the action under 37 CFR 1.135(c) before the initial reply (as corrected) can be treated on its merits. In addition, 37 CFR 1.704(c)(7) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed. The reference to 37 CFR 1.135(c) is parenthetical because 37 CFR 1.704(c)(7) is not limited to Office actions under 37 CFR 1.135(c) but applies also when the Office issues any action or notice indicating that a reply has an omission which must be corrected: for example, (1) a decision on a petition under 37 CFR 1.47 dismissing the petition as lacking an item necessary to grant the petition; or (2) a notice indicating that the computer readable sequence listing submitted in an application filed on or after July 1, 2022, in reply to a previous notice relating to the requirements for patent applications containing nucleotide and/or amino acid sequence disclosures, does not comply with 37 CFR 1.831 et seq. The filing of a non-compliant appeal brief, however, will not be deemed an omission under 37 CFR 1.704(c)(7) if the notice of appeal was filed on or after September 17, 2012. This situation is covered under 37 CFR 1.704(c)(11).

37 CFR 1.704(c)(7) establishes submission of a reply having an omission (e.g., 37 CFR 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under 37 CFR 1.135(c) and await and process the applicant’s reply to the action under 37 CFR 1.135(c) before the initial reply (as corrected) can be treated on its merits. In addition, 37 CFR 1.704(c)(7) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed. The reference to 37 CFR 1.135(c) is parenthetical because 37 CFR 1.704(c)(7) is not limited to Office actions under 37 CFR 1.135(c) but applies also when the Office issues any action or notice indicating that a reply has an omission which must be corrected: for example, (1) a decision on a petition under 37 CFR 1.47 dismissing the petition as lacking an item necessary to grant the petition; or (2) a notice indicating that the computer readable sequence listing submitted in an application filed on or after July 1, 2022, in reply to a previous notice relating to the requirements for patent applications containing nucleotide and/or amino acid sequence disclosures, does not comply with 37 CFR 1.831 et seq. The filing of a non-compliant appeal brief, however, will not be deemed an omission under 37 CFR 1.704(c)(7) if the notice of appeal was filed on or after September 17, 2012. This situation is covered under 37 CFR 1.704(c)(11).

37 CFR 1.704(c)(7) establishes submission of a reply having an omission (e.g., 37 CFR 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under 37 CFR 1.135(c) and await and process the applicant’s reply to the action under 37 CFR 1.135(c) before the initial reply (as corrected) can be treated on its merits. In addition, 37 CFR 1.704(c)(7) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed. The reference to 37 CFR 1.135(c) is parenthetical because 37 CFR 1.704(c)(7) is not limited to Office actions under 37 CFR 1.135(c) but applies also when the Office issues any action or notice indicating that a reply has an omission which must be corrected: for example, (1) a decision on a petition under 37 CFR 1.47 dismissing the petition as lacking an item necessary to grant the petition; or (2) a notice indicating that the computer readable sequence listing submitted in an application filed on or after July 1, 2022, in reply to a previous notice relating to the requirements for patent applications containing nucleotide and/or amino acid sequence disclosures, does not comply with 37 CFR 1.831 et seq. The filing of a non-compliant appeal brief, however, will not be deemed an omission under 37 CFR 1.704(c)(7) if the notice of appeal was filed on or after September 17, 2012. This situation is covered under 37 CFR 1.704(c)(11).

37 CFR 1.704(c)(9) establishes submission of an amendment or other paper (other than a statement under 37 CFR 41.50(c)) in an application after a decision by the Patent Trial and Appeal Board (other than a decision containing a rejection under 37 CFR 41.50(b)) or a federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151, that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of an amendment or other paper (e.g., IDS or petition) in an application after a Board decision or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office’s taking action on the application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(9) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a federal court and ending on the date the amendment or other paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance or four months. The phrase “lesser of…or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(9) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance. If the amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for OPSG to flag in the patent term adjustment calculation.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

In the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015), the Office revised policies regarding 37 CFR 1.704(c)(10). The revised policy does not consider the submission of a written (or other type of) status inquiry, request for refund, or an inventor’s oath or declaration to be a failure to engage in reasonable efforts to conclude processing and examination of the application under 37 CFR 1.704(c)(10) due to the changes that have been brought about by the electronic filing and processing of patent applications.

In the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015), the Office revised policies regarding 37 CFR 1.704(c)(10). The revised policy does not consider the submission of a written (or other type of) status inquiry, request for refund, or an inventor’s oath or declaration to be a failure to engage in reasonable efforts to conclude processing and examination of the application under 37 CFR 1.704(c)(10) due to the changes that have been brought about by the electronic filing and processing of patent applications.

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, 37 CFR 1.704(c)(12) was amended to provide a new provision that establishes the submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in which case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). This provision ensures that an applicant does not obtain additional patent term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance has been mailed as a consequence of delaying issuance of the patent by filing a request for continued examination under 35 U.S.C. 132(b) after a notice of allowance has been mailed. Moreover, the filing of a request for continued examination after the mailing of a notice of allowance removes the application from the issue process, prevents the Office from issuing the patent, and requires the Office to determine if the submission affects the patentability of the application, which adds to the pendency of the application in which the request for continued examination is filed (as well as other applications since examination resources must be diverted from other applications to the application in which the request for continued examination is filed). “An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as ‘engag[ing] in reasonable efforts to conclude processing or examination of an application’ (35 U.S.C. 154(b)(2)(C)(i)).” See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56379 (response to comment 17). Therefore, the Office considers it appropriate to expressly define the filing of a request for continued examination after the mailing of any notice of allowance as a failure to engage in reasonable efforts to conclude processing or examination of an application. See 35 U.S.C. 154(b)(2)(C)(iii) (provides for the Office to prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application).

Effective March 10, 2015, the provisions in 37 CFR 1.704(c)(12) and 37 CFR 1.704(c)(13) were relabeled as 37 CFR 1.704(c)(13) and 37 CFR 1.704(c)(14), respectively. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015).

For applications filed under 35 U.S.C. 111(a) on or after December 18, 2013 and international patent applications in which the national stage was commenced under 35 U.S.C. 371 on or after December 18, 2013, 37 CFR 1.704(c)(13) establishes that the circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application also include the failure to provide an application in condition for examination within eight months from the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application. Section 1.704(c)(13) does not require that applications be in condition for examination on filing (or commencement of national stage in an international application) in order for an applicant to avoid a reduction of patent term adjustment.

For applications filed under 35 U.S.C. 111(a) on or after December 18, 2013 and international patent applications in which the national stage was commenced under 35 U.S.C. 371 on or after December 18, 2013, 37 CFR 1.704(c)(13) establishes that the circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application also include the failure to provide an application in condition for examination within eight months from the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application. Section 1.704(c)(13) does not require that applications be in condition for examination on filing (or commencement of national stage in an international application) in order for an applicant to avoid a reduction of patent term adjustment.

37 CFR 1.704(c)(13) establishes that where there is a failure to provide an application in condition for examination within eight months from the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application, the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the application is in condition for examination.

37 CFR 1.704(c)(14) (which was formerly 37 CFR 1.704(c)(11), (c)(12), and (c)(13)) establishes further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Currently, a continuing application may be used to: (1) obtain further examination of an invention disclosed and claimed in the prior application (continuation application); (2) obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application (divisional application); or (3) obtain examination of an invention neither disclosed nor claimed in the prior application (continuation-in-part application). The provisions of 35 U.S.C. 132(b) and 37 CFR 1.114 permit an applicant to obtain further or continued examination of an invention disclosed and claimed in an application, which renders it unnecessary for an applicant whose application is eligible for patent term adjustment under 35 U.S.C. 154(b) to file a continuing application to obtain further examination of an invention disclosed and claimed in an application. If an applicant is filing a continuing application to obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application or an invention neither disclosed nor claimed in the prior application, it is not appropriate for that applicant to obtain any benefit in the continuing application for examination delays that might have occurred in the prior application. See Mohsenzadeh v. Lee, 790 F.3d 1377, 115 USPQ2d 1483 (Fed. Cir. 2015) where the district court upheld the Office’s position that patent term adjustment does not carry over to a continuing or divisional application. Thus, the Office has established further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in that the period of adjustment set forth in 37 CFR 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent. Thus, if the application that resulted in the patent is a continuing application (including a CPA), the period of adjustment set forth in 37 CFR 1.703 (if any) will not include any period that is prior to the actual filing date of the application (in the case of a CPA, the filing date of the request for a CPA) that resulted in the patent.

37 CFR 1.704(d)(1) requires that the information disclosure statement “is accompanied by” the safe harbor statement. In other words, the safe harbor statement must be filed concurrently with (therefore, on the same date as) the information disclosure statement according to 37 CFR 1.704(d)(1). However, the Office has provided a procedure for applicants to seek a waiver using a 37 CFR 1.183 petition to allow for a late-filed statement under 37 CFR 1.704. If an applicant submits an information disclosure statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but does not include a statement under 37 CFR 1.704 with the information disclosure statement (therefore, not filed on the same date), the applicant should consider filing a request for reconsideration of the patent term adjustment indicated on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 1.704(d) (if not previously filed) and petition under 37 CFR 1.183 (along with the fee under 37 CFR 1.17(f)) requesting that the Office consider the statement under 37 CFR 1.704(d) when making the patent term adjustment determination. Applicants should keep in mind that a petition under 37 CFR 1.183 may only be used to request acceptance of the late-filed statement under 37 CFR 1.704(d). Under no circumstances will an information disclosure statement filed more than 30 days from the applicable communication under 37 CFR 1.704(d)(1)(i) or (ii) be treated as filed within the “safe harbor” of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 1.704(d)(1) is not extendable. See 37 CFR 1.704(d)(2).

37 CFR 1.704(d)(1) requires that the information disclosure statement “is accompanied by” the safe harbor statement. In other words, the safe harbor statement must be filed concurrently with (therefore, on the same date as) the information disclosure statement according to 37 CFR 1.704(d)(1). However, the Office has provided a procedure for applicants to seek a waiver using a 37 CFR 1.183 petition to allow for a late-filed statement under 37 CFR 1.704. If an applicant submits an information disclosure statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but does not include a statement under 37 CFR 1.704 with the information disclosure statement (therefore, not filed on the same date), the applicant should consider filing a request for reconsideration of the patent term adjustment indicated on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 1.704(d) (if not previously filed) and petition under 37 CFR 1.183 (along with the fee under 37 CFR 1.17(f)) requesting that the Office consider the statement under 37 CFR 1.704(d) when making the patent term adjustment determination. Applicants should keep in mind that a petition under 37 CFR 1.183 may only be used to request acceptance of the late-filed statement under 37 CFR 1.704(d). Under no circumstances will an information disclosure statement filed more than 30 days from the applicable communication under 37 CFR 1.704(d)(1)(i) or (ii) be treated as filed within the “safe harbor” of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 1.704(d)(1) is not extendable. See 37 CFR 1.704(d)(2).

37 CFR 1.704(d)(1) requires that the information disclosure statement “is accompanied by” the safe harbor statement. In other words, the safe harbor statement must be filed concurrently with (therefore, on the same date as) the information disclosure statement according to 37 CFR 1.704(d)(1). However, the Office has provided a procedure for applicants to seek a waiver using a 37 CFR 1.183 petition to allow for a late-filed statement under 37 CFR 1.704. If an applicant submits an information disclosure statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but does not include a statement under 37 CFR 1.704 with the information disclosure statement (therefore, not filed on the same date), the applicant should consider filing a request for reconsideration of the patent term adjustment indicated on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 1.704(d) (if not previously filed) and petition under 37 CFR 1.183 (along with the fee under 37 CFR 1.17(f)) requesting that the Office consider the statement under 37 CFR 1.704(d) when making the patent term adjustment determination. Applicants should keep in mind that a petition under 37 CFR 1.183 may only be used to request acceptance of the late-filed statement under 37 CFR 1.704(d). Under no circumstances will an information disclosure statement filed more than 30 days from the applicable communication under 37 CFR 1.704(d)(1)(i) or (ii) be treated as filed within the “safe harbor” of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 1.704(d)(1) is not extendable. See 37 CFR 1.704(d)(2).

37 CFR 1.704(d)(1) requires that the information disclosure statement “is accompanied by” the safe harbor statement. In other words, the safe harbor statement must be filed concurrently with (therefore, on the same date as) the information disclosure statement according to 37 CFR 1.704(d)(1). However, the Office has provided a procedure for applicants to seek a waiver using a 37 CFR 1.183 petition to allow for a late-filed statement under 37 CFR 1.704. If an applicant submits an information disclosure statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but does not include a statement under 37 CFR 1.704 with the information disclosure statement (therefore, not filed on the same date), the applicant should consider filing a request for reconsideration of the patent term adjustment indicated on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 1.704(d) (if not previously filed) and petition under 37 CFR 1.183 (along with the fee under 37 CFR 1.17(f)) requesting that the Office consider the statement under 37 CFR 1.704(d) when making the patent term adjustment determination. Applicants should keep in mind that a petition under 37 CFR 1.183 may only be used to request acceptance of the late-filed statement under 37 CFR 1.704(d). Under no circumstances will an information disclosure statement filed more than 30 days from the applicable communication under 37 CFR 1.704(d)(1)(i) or (ii) be treated as filed within the “safe harbor” of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 1.704(d)(1) is not extendable. See 37 CFR 1.704(d)(2).

37 CFR 1.704(d)(1) requires that the information disclosure statement “is accompanied by” the safe harbor statement. In other words, the safe harbor statement must be filed concurrently with (therefore, on the same date as) the information disclosure statement according to 37 CFR 1.704(d)(1). However, the Office has provided a procedure for applicants to seek a waiver using a 37 CFR 1.183 petition to allow for a late-filed statement under 37 CFR 1.704. If an applicant submits an information disclosure statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but does not include a statement under 37 CFR 1.704 with the information disclosure statement (therefore, not filed on the same date), the applicant should consider filing a request for reconsideration of the patent term adjustment indicated on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 1.704(d) (if not previously filed) and petition under 37 CFR 1.183 (along with the fee under 37 CFR 1.17(f)) requesting that the Office consider the statement under 37 CFR 1.704(d) when making the patent term adjustment determination. Applicants should keep in mind that a petition under 37 CFR 1.183 may only be used to request acceptance of the late-filed statement under 37 CFR 1.704(d). Under no circumstances will an information disclosure statement filed more than 30 days from the applicable communication under 37 CFR 1.704(d)(1)(i) or (ii) be treated as filed within the “safe harbor” of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 1.704(d)(1) is not extendable. See 37 CFR 1.704(d)(2).

In order to aid the Office in recognizing when a compliant safe harbor statement under 37 CFR 1.704(d) has been filed with an information disclosure statement, the Office has created a form PTO/SB/133 “Patent Term Adjustment Statement under 37 CFR 1.704(d)” for applicant’s use when submitting the information disclosure statement. The Office has also updated the patent term adjustment computer program to recognize that form PTO/SB/133 has been filed concurrently with (therefore, on the same date as) the information disclosure statement using document code PTA.IDS. When form PTO/SB/133 is recognized, the patent term adjustment computer program will perform the patent term calculation by taking into account that applicant filed a compliant safe harbor statement under 37 CFR 1.704(d).

Use of form PTO/SB/133 was not required for safe harbor statements filed before July 17, 2023. However, safe harbor statements under 37 CFR 1.704(d) filed on or after July 17, 2023, must be submitted on form PTO/SB/133 using the document code PTA.IDS. See 37 CFR 1.704(d)(3). The form is available on the USPTO’s website at (www.uspto.gov/PatentForms) and is reproduced below at the end of this section. The Office of Management and Budget (OMB) has determined that, under 5 CFR 1320.3(h), form PTO/SB/133 does not collect “information” within the meaning of the Paperwork Reduction Act of 1995.

Use of form PTO/SB/133 was not required for safe harbor statements filed before July 17, 2023. However, safe harbor statements under 37 CFR 1.704(d) filed on or after July 17, 2023, must be submitted on form PTO/SB/133 using the document code PTA.IDS. See 37 CFR 1.704(d)(3). The form is available on the USPTO’s website at (www.uspto.gov/PatentForms) and is reproduced below at the end of this section. The Office of Management and Budget (OMB) has determined that, under 5 CFR 1320.3(h), form PTO/SB/133 does not collect “information” within the meaning of the Paperwork Reduction Act of 1995.

While the Office encourages the filing of correspondence via the USPTO patent electronic filing system, the inclusion of document code PTA.IDS on the form PTO/SB/133 satisfies the “using the appropriate document code (PTA.IDS)” requirement of 37 CFR 1.704(d)(3) for statements under 37 CFR 1.704(d) not submitted via the USPTO patent electronic filing system. Applicants may no longer use the document code PTA.IDS, which is specific to form PTO/SB/133, on or after July 17, 2023, unless they are using form PTO/SB/133. Applicants filing a statement under 37 CFR 1.704(d) on or after July 17, 2023, without form PTO/SB/133 may only use document code IDS for submission of an information disclosure statement. If a statement under 37 CFR 1.704(d) is not filed using form PTO/SB/133 or does not use document code PTA.IDS, the application will be treated as if no safe harbor statement under 37 CFR 1.704(d) had been filed unless a request for reconsideration of patent term adjustment, in compliance with 37 CFR 1.705(b), is filed establishing that the information disclosure statement was accompanied by a safe harbor statement.

While the Office encourages the filing of correspondence via the USPTO patent electronic filing system, the inclusion of document code PTA.IDS on the form PTO/SB/133 satisfies the “using the appropriate document code (PTA.IDS)” requirement of 37 CFR 1.704(d)(3) for statements under 37 CFR 1.704(d) not submitted via the USPTO patent electronic filing system. Applicants may no longer use the document code PTA.IDS, which is specific to form PTO/SB/133, on or after July 17, 2023, unless they are using form PTO/SB/133. Applicants filing a statement under 37 CFR 1.704(d) on or after July 17, 2023, without form PTO/SB/133 may only use document code IDS for submission of an information disclosure statement. If a statement under 37 CFR 1.704(d) is not filed using form PTO/SB/133 or does not use document code PTA.IDS, the application will be treated as if no safe harbor statement under 37 CFR 1.704(d) had been filed unless a request for reconsideration of patent term adjustment, in compliance with 37 CFR 1.705(b), is filed establishing that the information disclosure statement was accompanied by a safe harbor statement.

While the Office encourages the filing of correspondence via the USPTO patent electronic filing system, the inclusion of document code PTA.IDS on the form PTO/SB/133 satisfies the “using the appropriate document code (PTA.IDS)” requirement of 37 CFR 1.704(d)(3) for statements under 37 CFR 1.704(d) not submitted via the USPTO patent electronic filing system. Applicants may no longer use the document code PTA.IDS, which is specific to form PTO/SB/133, on or after July 17, 2023, unless they are using form PTO/SB/133. Applicants filing a statement under 37 CFR 1.704(d) on or after July 17, 2023, without form PTO/SB/133 may only use document code IDS for submission of an information disclosure statement. If a statement under 37 CFR 1.704(d) is not filed using form PTO/SB/133 or does not use document code PTA.IDS, the application will be treated as if no safe harbor statement under 37 CFR 1.704(d) had been filed unless a request for reconsideration of patent term adjustment, in compliance with 37 CFR 1.705(b), is filed establishing that the information disclosure statement was accompanied by a safe harbor statement.

Applicants who submit form PTO/SB/133 with an information disclosure statement and use document code PTA.IDS will be considered to be making a proper safe harbor statement, and the filing will be reflected in the file record. Applicants may not alter the pre-printed text of form PTO/SB/133. The presentation to the Office (whether by signing, filing, submitting, or later advocating) of form PTO/SB/133, whether by a practitioner or non-practitioner, constitutes a certification under 37 CFR 11.18(b) that the existing text and any certification statements on the form have not been altered. See 37 CFR 1.704(d)(3). Also, the use of document code PTA.IDS on or after July 17, 2023, which is specifically for form PTO/SB/133, is a representation that the applicant is filing form PTO/SB/133 with no alterations to the text of the form. As a result of using the form PTO/SB/133 and document code PTA.IDS with a submission of an information disclosure statement, the Office’s computer program will take the safe harbor statement into account when patent term adjustment is calculated, thereby eliminating the need to file a request for reconsideration of patent term adjustment under 37 CFR 1.705(b) for this matter.

Applicants who submit form PTO/SB/133 with an information disclosure statement and use document code PTA.IDS will be considered to be making a proper safe harbor statement, and the filing will be reflected in the file record. Applicants may not alter the pre-printed text of form PTO/SB/133. The presentation to the Office (whether by signing, filing, submitting, or later advocating) of form PTO/SB/133, whether by a practitioner or non-practitioner, constitutes a certification under 37 CFR 11.18(b) that the existing text and any certification statements on the form have not been altered. See 37 CFR 1.704(d)(3). Also, the use of document code PTA.IDS on or after July 17, 2023, which is specifically for form PTO/SB/133, is a representation that the applicant is filing form PTO/SB/133 with no alterations to the text of the form. As a result of using the form PTO/SB/133 and document code PTA.IDS with a submission of an information disclosure statement, the Office’s computer program will take the safe harbor statement into account when patent term adjustment is calculated, thereby eliminating the need to file a request for reconsideration of patent term adjustment under 37 CFR 1.705(b) for this matter.

The provision in 37 CFR 1.704(d) will permit applicants to submit information first cited in any communication from a patent office in a counterpart foreign or international application or from the Office in another application without a reduction in patent term adjustment if an information disclosure statement is promptly (within thirty days of receipt of the first communication) submitted to the Office. Specifically, information first cited in any communication from a foreign patent office or this Office and received by an individual designated in 37 CFR 1.56(c) more than thirty days before the filing of the information disclosure statement is not entitled to the safe harbor provision, even if the same information is once again cited by another foreign patent office or this Office within thirty days prior to the filing of the information disclosure statement in the Office. This is because the applicant was aware of the information more than thirty days before the filing of the information disclosure statement, yet did not submit that information. The term “any” in “any communication” was used in 37 CFR 1.704(d)(1)(i) to make the distinction clear. This provision also permits an applicant to submit communications that were issued by a patent office in a counterpart foreign or international application or by the Office that were not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement to avoid a reduction in any patent term adjustment. See 37 CFR 1.704(d)(1)(ii).

Compliance with the statement requirement of 37 CFR 1.704(d) does not substitute for compliance with any relevant requirement of 37 CFR 1.97 or 1.98. 37 CFR 1.704(d)(2) also provides that this thirty-day period is not extendable.

Compliance with the statement requirement of 37 CFR 1.704(d) does not substitute for compliance with any relevant requirement of 37 CFR 1.97 or 1.98. 37 CFR 1.704(d)(2) also provides that this thirty-day period is not extendable.

Based on these elements of 37 CFR 1.56(c), the following three examples provide guidance in regard to the discussed situations.

The thirty-day period would be calculated from January 12, 2002. As such, the IDS received on February 11, 2002 would be filed within the thirty-day period in 37 CFR 1.704(d), and thus would not result in a reduction of any patent term adjustment pursuant to 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10).

The thirty-day period would be calculated from January 12, 2002. As such, the IDS received on February 11, 2002 would be filed within the thirty-day period in 37 CFR 1.704(d), and thus would not result in a reduction of any patent term adjustment pursuant to 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10).

In this example, the foreign counsel has no substantive role in the prosecution of the U.S. application. The explicitly defined role of the foreign counsel relative to the U.S. counsel in combination with the practice in the described fact pattern removes any potential doubt as to the role of the foreign counsel. For these reasons, the foreign counsel is not deemed a person who is substantially involved in the U.S. application under 37 CFR 1.56(c).

The thirty-day period would be calculated from January 5, 2002. As such, the submission of the IDS would not be received within the thirty-day window in 37 CFR 1.704(d), and thus could result in a reduction of any patent term pursuant to 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10).

The thirty-day period would be calculated from January 5, 2002. As such, the submission of the IDS would not be received within the thirty-day window in 37 CFR 1.704(d), and thus could result in a reduction of any patent term pursuant to 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10).

The thirty-day period would be calculated from January 5, 2002. As such, the submission of the IDS would be determined to have not been received within the thirty-day period in 37 CFR 1.704(d), and thus could result in a reduction of any patent term pursuant to 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10).

The thirty-day period would be calculated from January 5, 2002. As such, the submission of the IDS would be determined to have not been received within the thirty-day period in 37 CFR 1.704(d), and thus could result in a reduction of any patent term pursuant to 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10).

In this example, the USPTO would consider the participation of the German attorney in the prosecution and decision-making as to the relevance of the newly cited art vis-à-vis the previously cited three patents to be a substantive participation in the U.S. prosecution. As such, the German attorney would be considered by the USPTO to be a party covered by 37 CFR 1.56(c). Accordingly, evaluation of compliance with 37 CFR 1.704(d) would consider the date that the foreign counsel first learned of the fourth patent (i.e., the newly cited reference).

37 CFR 1.704(e) provides that a submission of a request under 37 CFR 1.705(c) for reinstatement of reduced patent term adjustment will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(10). The Office will not deem such a failure to engage in reasonable efforts to conclude processing or examination of the application under 37 CFR 1.704(c)(10) because the statute expressly requires that all such requests be filed prior to the issuance of the patent. See 35 U.S.C. 154(b)(3)(C).

37 CFR 1.704(f) defines what is meant by “condition for examination” for purposes of 37 CFR 1.704(c)(13). Specifically, 37 CFR 1.704(f) defines that an application filed under 35 U.S.C. 111(a) is in condition for examination when it includes a specification, including at least one claim and an abstract (37 CFR 1.72(b)), and has papers in compliance with 37 CFR 1.52, drawings (if any) in compliance with 37 CFR 1.84, any English translation required by 37 CFR 1.52(d) or 37 CFR 1.57(a), a “Sequence Listing” incompliance with 37 CFR 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835 (if applicable), an inventor's oath or declaration or an application data sheet containing the information specified in 37 CFR 1.63(b), the basic filing fee (37 CFR 1.16(a) or (c)), the search fee (37 CFR 1.16(k) or (m)), the examination fee (37 CFR 1.16(o) or (q)), any certified copy of the previously filed application required by 37 CFR 1.57(a), and any application size fee required by the Office under 37 CFR 1.16(s).

37 CFR 1.704(f) also provides that an international application is in condition for examination when the application has entered the national stage as defined in 37 CFR 1.491(b), and includes a specification, including at least one claim and an abstract (37 CFR 1.72(b)), and has papers in compliance with 37 CFR 1.52, drawings (if any) in compliance with 37 CFR 1.84, a “Sequence Listing” in compliance with 37 CFR 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835 (if applicable), an inventor's oath or declaration or an application data sheet containing the information specified 37 CFR 1.63(b), the search fee (37 CFR 1.492(b)), the examination fee (37 CFR 1.492(c)), and any application size fee required by the Office under 37 CFR 1.492(j). 37 CFR 1.704(f) also provides that an application shall be considered as having papers in compliance with 37 CFR 1.52, drawings (if any) in compliance with 37 CFR 1.84, and a “Sequence Listing” in compliance with 37 CFR 1.821 through 1.825 (if applicable), or a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835 (if applicable) for purposes of 37 CFR 1.704(f) on the filing date of the latest reply (if any) correcting the papers, drawings, “Sequence Listing”, or “Sequence Listing XML” that is prior to the date of mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151, whichever occurs first.

37 CFR 1.704(f) also provides that an international application is in condition for examination when the application has entered the national stage as defined in 37 CFR 1.491(b), and includes a specification, including at least one claim and an abstract (37 CFR 1.72(b)), and has papers in compliance with 37 CFR 1.52, drawings (if any) in compliance with 37 CFR 1.84, a “Sequence Listing” in compliance with 37 CFR 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835 (if applicable), an inventor's oath or declaration or an application data sheet containing the information specified 37 CFR 1.63(b), the search fee (37 CFR 1.492(b)), the examination fee (37 CFR 1.492(c)), and any application size fee required by the Office under 37 CFR 1.492(j). 37 CFR 1.704(f) also provides that an application shall be considered as having papers in compliance with 37 CFR 1.52, drawings (if any) in compliance with 37 CFR 1.84, and a “Sequence Listing” in compliance with 37 CFR 1.821 through 1.825 (if applicable), or a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835 (if applicable) for purposes of 37 CFR 1.704(f) on the filing date of the latest reply (if any) correcting the papers, drawings, “Sequence Listing”, or “Sequence Listing XML” that is prior to the date of mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151, whichever occurs first.

(a) The period of adjustment of the term of a patent under §§ 1.703(a) through (e) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application.

37 CFR 1.704 implements the provisions of 35 U.S.C. 154(b)(2)(C) which provides that the period of patent term adjustment under 35 U.S.C. 154(b)(1) “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application,” and specifies certain circumstances as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Further, 35 U.S.C. 154(b)(2)(C)(iii) gives the Office the authority to prescribe regulations establishing circumstances that constitute “a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C) does not require the applicant’s action or inaction (that amounts to a failure to engage in reasonable efforts to conclude prosecution of the application) to have caused or contributed to patent term adjustment for the period of adjustment to be reduced due to such action or inaction. The patent term adjustment provisions of 35 U.S.C. 154(b) create a balanced system allowing for patent term adjustment due to Office delays for a reasonably diligent applicant. Since the public has an interest in the technology disclosed and covered by a patent being available to the public at the earliest possible date, 35 U.S.C. 154(b)(2)(C)(i) provides that patent term adjustment is reduced by any period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application, regardless of whether the applicant’s actions or inactions caused or contributed to patent term adjustment.

37 CFR 1.704 implements the provisions of 35 U.S.C. 154(b)(2)(C) which provides that the period of patent term adjustment under 35 U.S.C. 154(b)(1) “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application,” and specifies certain circumstances as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Further, 35 U.S.C. 154(b)(2)(C)(iii) gives the Office the authority to prescribe regulations establishing circumstances that constitute “a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C) does not require the applicant’s action or inaction (that amounts to a failure to engage in reasonable efforts to conclude prosecution of the application) to have caused or contributed to patent term adjustment for the period of adjustment to be reduced due to such action or inaction. The patent term adjustment provisions of 35 U.S.C. 154(b) create a balanced system allowing for patent term adjustment due to Office delays for a reasonably diligent applicant. Since the public has an interest in the technology disclosed and covered by a patent being available to the public at the earliest possible date, 35 U.S.C. 154(b)(2)(C)(i) provides that patent term adjustment is reduced by any period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application, regardless of whether the applicant’s actions or inactions caused or contributed to patent term adjustment.

If a petition to withdraw the holding of abandonment is granted, the Office’s OPSG system records should be checked to ensure that the correct term adjustment determination is made. Applicants are encouraged to check the Office’s OPSG system records for their applications through the USPTO patent electronic filing system (see MPEP § 2733). For example, if applicant shows in the petition that a reply was filed in the Office on March 2, but the March 2 reply was never matched with the file, when the petition to withdraw the holding of abandonment is granted, the receipt of a paper on March 2 should be recorded on the Office’s OPSG system records. If the papers or dates are recorded incorrectly, applicant should contact the examiner, the examiner’s supervisor or the Technology Center customer service representative to have the entry corrected. If an applicant receives a Notice of Abandonment and does not request that the holding of abandonment be withdrawn within two months of the date of mailing of the notice, the applicant has failed to engage in reasonable efforts to conclude prosecution and any patent term adjustment will be reduced pursuant to 37 CFR 1.704(c)(4).

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

If the Office reopens prosecution of the application more than three months after the filing of the notice of appeal but prior to the submission of a compliant appeal brief, the Office will not deem the period of time from the day after three months from the filing of the notice of appeal to the date the Office reopens prosecution to be an applicant delay under 37 CFR 1.704(c)(11). In addition, the Office’s reopening of prosecution after appeal will not be considered as vacating any previous response that potentially increases patent term adjustment under 35 U.S.C. 154(b)(1)(A)(i) through (iv). As discussed above, the change to 37 CFR 1.704(c)(11) is applicable to any applications that includes an appeal brief in which the notice of appeal was filed on or after September 17, 2012.

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, 37 CFR 1.704(c)(12) was amended to provide a new provision that establishes the submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in which case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). This provision ensures that an applicant does not obtain additional patent term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance has been mailed as a consequence of delaying issuance of the patent by filing a request for continued examination under 35 U.S.C. 132(b) after a notice of allowance has been mailed. Moreover, the filing of a request for continued examination after the mailing of a notice of allowance removes the application from the issue process, prevents the Office from issuing the patent, and requires the Office to determine if the submission affects the patentability of the application, which adds to the pendency of the application in which the request for continued examination is filed (as well as other applications since examination resources must be diverted from other applications to the application in which the request for continued examination is filed). “An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as ‘engag[ing] in reasonable efforts to conclude processing or examination of an application’ (35 U.S.C. 154(b)(2)(C)(i)).” See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56379 (response to comment 17). Therefore, the Office considers it appropriate to expressly define the filing of a request for continued examination after the mailing of any notice of allowance as a failure to engage in reasonable efforts to conclude processing or examination of an application. See 35 U.S.C. 154(b)(2)(C)(iii) (provides for the Office to prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application).

Effective March 10, 2015, the provisions in 37 CFR 1.704(c)(12) and 37 CFR 1.704(c)(13) were relabeled as 37 CFR 1.704(c)(13) and 37 CFR 1.704(c)(14), respectively. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015).

In order to aid the Office in recognizing when a compliant safe harbor statement under 37 CFR 1.704(d) has been filed with an information disclosure statement, the Office has created a form PTO/SB/133 “Patent Term Adjustment Statement under 37 CFR 1.704(d)” for applicant’s use when submitting the information disclosure statement. The Office has also updated the patent term adjustment computer program to recognize that form PTO/SB/133 has been filed concurrently with (therefore, on the same date as) the information disclosure statement using document code PTA.IDS. When form PTO/SB/133 is recognized, the patent term adjustment computer program will perform the patent term calculation by taking into account that applicant filed a compliant safe harbor statement under 37 CFR 1.704(d).

While the Office encourages the filing of correspondence via the USPTO patent electronic filing system, the inclusion of document code PTA.IDS on the form PTO/SB/133 satisfies the “using the appropriate document code (PTA.IDS)” requirement of 37 CFR 1.704(d)(3) for statements under 37 CFR 1.704(d) not submitted via the USPTO patent electronic filing system. Applicants may no longer use the document code PTA.IDS, which is specific to form PTO/SB/133, on or after July 17, 2023, unless they are using form PTO/SB/133. Applicants filing a statement under 37 CFR 1.704(d) on or after July 17, 2023, without form PTO/SB/133 may only use document code IDS for submission of an information disclosure statement. If a statement under 37 CFR 1.704(d) is not filed using form PTO/SB/133 or does not use document code PTA.IDS, the application will be treated as if no safe harbor statement under 37 CFR 1.704(d) had been filed unless a request for reconsideration of patent term adjustment, in compliance with 37 CFR 1.705(b), is filed establishing that the information disclosure statement was accompanied by a safe harbor statement.

Applicants who submit form PTO/SB/133 with an information disclosure statement and use document code PTA.IDS will be considered to be making a proper safe harbor statement, and the filing will be reflected in the file record. Applicants may not alter the pre-printed text of form PTO/SB/133. The presentation to the Office (whether by signing, filing, submitting, or later advocating) of form PTO/SB/133, whether by a practitioner or non-practitioner, constitutes a certification under 37 CFR 11.18(b) that the existing text and any certification statements on the form have not been altered. See 37 CFR 1.704(d)(3). Also, the use of document code PTA.IDS on or after July 17, 2023, which is specifically for form PTO/SB/133, is a representation that the applicant is filing form PTO/SB/133 with no alterations to the text of the form. As a result of using the form PTO/SB/133 and document code PTA.IDS with a submission of an information disclosure statement, the Office’s computer program will take the safe harbor statement into account when patent term adjustment is calculated, thereby eliminating the need to file a request for reconsideration of patent term adjustment under 37 CFR 1.705(b) for this matter.

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

37 CFR 1.704(c)(6) establishes submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. If the submission of a preliminary amendment or other paper requires the Office to issue a supplemental Office action or notice of allowance, the submission of that preliminary amendment or other paper has interfered with the processing and examination of an application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(6) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance or four months. The phrase “lesser of… or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(6) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance.

37 CFR 1.704(c)(6) establishes submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. If the submission of a preliminary amendment or other paper requires the Office to issue a supplemental Office action or notice of allowance, the submission of that preliminary amendment or other paper has interfered with the processing and examination of an application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(6) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance or four months. The phrase “lesser of… or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(6) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance.

37 CFR 1.704(c)(6) establishes submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. If the submission of a preliminary amendment or other paper requires the Office to issue a supplemental Office action or notice of allowance, the submission of that preliminary amendment or other paper has interfered with the processing and examination of an application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(6) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance or four months. The phrase “lesser of… or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(6) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance.

Applicant’s submission of an information disclosure statement pursuant to 37 CFR 1.97(c) or an amendment under 37 CFR 41.33 after a notice of appeal has been filed but prior to jurisdiction passing to the Patent Trial and Appeal Board is deemed an applicant delay under 37 CFR 1.704(c)(8). Under 37 CFR 1.97(c), an applicant who submits an information disclosure statement meeting the requirements of 37 CFR 1.97 and 1.98 will have such submission considered by the examiner if it is accompanied by a statement under 37 CFR 1.97(e) and the fee under 37 CFR 1.17(p). Moreover, the Office may admit an amendment after notice of appeal if it meets the applicable requirements in 37 CFR 41.33(a) and (b) for consideration. Because the treatment of these papers may delay the Board taking jurisdiction of the application, the Office will treat such papers similarly to how the Office treats a supplemental reply under this provision, in that the papers will be considered as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

Under 37 CFR 1.704(c)(10), papers that will be considered a failure to engage in reasonable efforts to conclude processing or examination of an application include: (1) an amendment under 37 CFR 1.312; (2) a paper containing a claim for priority or benefit or request to correct priority or benefit information (e.g., a new or supplemental application data sheet filed to correct foreign priority or domestic benefit information); (3) a request for a corrected filing receipt; (4) a certified copy of a priority document; (5) drawings; (6) a letter related to biologic deposits; (7) a request to change or correct inventorship; and (8) an information disclosure statement not accompanied by a statement in compliance with 37 CFR 1.704(d).

Effective for applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2), (c)(3), (c)(6), (c)(9), and (c)(10) were substantively amended in the final rule Patent Term Adjustment Reductions in View of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 85 FR 36335 (June 16, 2020). These paragraphs, as amended, were revised to state the period of reduction is equal to “the period from the beginning to the end of the applicant’s failure to engage in reasonable efforts to conclude prosecution” and that the reduction cannot exceed the period of time during which an applicant failed to engage in reasonable efforts. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019). The Office will decide any timely request for reconsideration in compliance with 37 CFR 1.705(b) of a patent term adjustment determination in applications or patents eligible for patent term adjustment in which a notice of allowance mailed prior to July 16, 2020, consistent with the changes in the final rule, as discussed below, if requested by the patentee.

37 CFR 1.704(c)(1) establishes suspension of action under 37 CFR 1.103 at the applicant’s request as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if action is suspended at the applicant’s request, the Office is precluded from processing or examining the application as a result of an action by the applicant. 37 CFR 1.704(c)(1) also provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for suspension of action under 37 CFR 1.103 was filed and ending on the date of the termination of the suspension.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, if such a request for continued examination is filed after payment of the issue fee, any patent term adjustment would be reduced by the number of days in the period starting on the day after the date of mailing of the notice of allowance and ending on the date the request for continued examination was filed. 35 U.S.C. 154(b)(1)(A)(iv) provides that, subject to the limitations under 35 U.S.C. 154(b)(2), if the issue of an original patent is delayed due to the failure of the Office to issue a patent within four months after the date on which the issue fee was paid under 35 U.S.C. 151 and all outstanding requirements were satisfied, the term of the patent shall be extended one day for each day after the date on which the issue fee was paid and all outstanding requirements were satisfied until the patent is issued. Thus, the period of adjustment under 35 U.S.C. 154(b)(1)(A)(iv), if any, is ascertained by looking back from the issue date to the most recent time at which the issue fee or another requirement was outstanding, determining the succeeding date on which the issue fee was paid and all outstanding requirements were satisfied, and measuring the number of days, if any, in the period beginning on the day after the date that is four months after such date the issue fee was paid and all outstanding requirements were satisfied and ending on the date a patent was issued. Where prosecution in an application is reopened after a notice of allowance (before or after payment of the issue fee), either by the Office sua sponte or as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). See MPEP § 2731. The mailing of a notice of allowance by the Office subsequent to the reopening of prosecution is the Office’s indication that the application is (again) in condition to be issued as a patent, and the applicant’s return of the Issue Fee Transmittal Form (PTOL-85(b)) is the applicant’s indication or confirmation that the applicant wants any previously paid issue fee to be applied as the issue fee for the patent. See MPEP § 1306. Thus, if prosecution in an application is reopened after a notice of allowance as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). Applicants should note that 37 CFR 1.114 does not permit an applicant to file a request for continued examination under 35 U.S.C. 132(b) after the date the issue fee is paid as a matter of right. See 37 CFR 1.114(a)(1).

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, if such a request for continued examination is filed after payment of the issue fee, any patent term adjustment would be reduced by the number of days in the period starting on the day after the date of mailing of the notice of allowance and ending on the date the request for continued examination was filed. 35 U.S.C. 154(b)(1)(A)(iv) provides that, subject to the limitations under 35 U.S.C. 154(b)(2), if the issue of an original patent is delayed due to the failure of the Office to issue a patent within four months after the date on which the issue fee was paid under 35 U.S.C. 151 and all outstanding requirements were satisfied, the term of the patent shall be extended one day for each day after the date on which the issue fee was paid and all outstanding requirements were satisfied until the patent is issued. Thus, the period of adjustment under 35 U.S.C. 154(b)(1)(A)(iv), if any, is ascertained by looking back from the issue date to the most recent time at which the issue fee or another requirement was outstanding, determining the succeeding date on which the issue fee was paid and all outstanding requirements were satisfied, and measuring the number of days, if any, in the period beginning on the day after the date that is four months after such date the issue fee was paid and all outstanding requirements were satisfied and ending on the date a patent was issued. Where prosecution in an application is reopened after a notice of allowance (before or after payment of the issue fee), either by the Office sua sponte or as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). See MPEP § 2731. The mailing of a notice of allowance by the Office subsequent to the reopening of prosecution is the Office’s indication that the application is (again) in condition to be issued as a patent, and the applicant’s return of the Issue Fee Transmittal Form (PTOL-85(b)) is the applicant’s indication or confirmation that the applicant wants any previously paid issue fee to be applied as the issue fee for the patent. See MPEP § 1306. Thus, if prosecution in an application is reopened after a notice of allowance as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). Applicants should note that 37 CFR 1.114 does not permit an applicant to file a request for continued examination under 35 U.S.C. 132(b) after the date the issue fee is paid as a matter of right. See 37 CFR 1.114(a)(1).

37 CFR 1.704(c)(14) (which was formerly 37 CFR 1.704(c)(11), (c)(12), and (c)(13)) establishes further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Currently, a continuing application may be used to: (1) obtain further examination of an invention disclosed and claimed in the prior application (continuation application); (2) obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application (divisional application); or (3) obtain examination of an invention neither disclosed nor claimed in the prior application (continuation-in-part application). The provisions of 35 U.S.C. 132(b) and 37 CFR 1.114 permit an applicant to obtain further or continued examination of an invention disclosed and claimed in an application, which renders it unnecessary for an applicant whose application is eligible for patent term adjustment under 35 U.S.C. 154(b) to file a continuing application to obtain further examination of an invention disclosed and claimed in an application. If an applicant is filing a continuing application to obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application or an invention neither disclosed nor claimed in the prior application, it is not appropriate for that applicant to obtain any benefit in the continuing application for examination delays that might have occurred in the prior application. See Mohsenzadeh v. Lee, 790 F.3d 1377, 115 USPQ2d 1483 (Fed. Cir. 2015) where the district court upheld the Office’s position that patent term adjustment does not carry over to a continuing or divisional application. Thus, the Office has established further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in that the period of adjustment set forth in 37 CFR 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent. Thus, if the application that resulted in the patent is a continuing application (including a CPA), the period of adjustment set forth in 37 CFR 1.703 (if any) will not include any period that is prior to the actual filing date of the application (in the case of a CPA, the filing date of the request for a CPA) that resulted in the patent.

A CPA under 37 CFR 1.53(d) filed on or after May 29, 2000 and before July 14, 2003 is entitled to the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by section 4402 of the American Inventors Protection Act of 1999 (CPAs can only be filed in design patent applications on or after July 14, 2003, and design applications are not entitled to PTA). The period of patent term adjustment set forth in 37 CFR 1.703 (if any), however, will not include any period that is prior to the filing date of the request for that CPA.

Applicants who submit form PTO/SB/133 with an information disclosure statement and use document code PTA.IDS will be considered to be making a proper safe harbor statement, and the filing will be reflected in the file record. Applicants may not alter the pre-printed text of form PTO/SB/133. The presentation to the Office (whether by signing, filing, submitting, or later advocating) of form PTO/SB/133, whether by a practitioner or non-practitioner, constitutes a certification under 37 CFR 11.18(b) that the existing text and any certification statements on the form have not been altered. See 37 CFR 1.704(d)(3). Also, the use of document code PTA.IDS on or after July 17, 2023, which is specifically for form PTO/SB/133, is a representation that the applicant is filing form PTO/SB/133 with no alterations to the text of the form. As a result of using the form PTO/SB/133 and document code PTA.IDS with a submission of an information disclosure statement, the Office’s computer program will take the safe harbor statement into account when patent term adjustment is calculated, thereby eliminating the need to file a request for reconsideration of patent term adjustment under 37 CFR 1.705(b) for this matter.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, 37 CFR 1.704(c)(12) was amended to provide a new provision that establishes the submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in which case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). This provision ensures that an applicant does not obtain additional patent term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance has been mailed as a consequence of delaying issuance of the patent by filing a request for continued examination under 35 U.S.C. 132(b) after a notice of allowance has been mailed. Moreover, the filing of a request for continued examination after the mailing of a notice of allowance removes the application from the issue process, prevents the Office from issuing the patent, and requires the Office to determine if the submission affects the patentability of the application, which adds to the pendency of the application in which the request for continued examination is filed (as well as other applications since examination resources must be diverted from other applications to the application in which the request for continued examination is filed). “An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as ‘engag[ing] in reasonable efforts to conclude processing or examination of an application’ (35 U.S.C. 154(b)(2)(C)(i)).” See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56379 (response to comment 17). Therefore, the Office considers it appropriate to expressly define the filing of a request for continued examination after the mailing of any notice of allowance as a failure to engage in reasonable efforts to conclude processing or examination of an application. See 35 U.S.C. 154(b)(2)(C)(iii) (provides for the Office to prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application).

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, 37 CFR 1.704(c)(12) was amended to provide a new provision that establishes the submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in which case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). This provision ensures that an applicant does not obtain additional patent term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance has been mailed as a consequence of delaying issuance of the patent by filing a request for continued examination under 35 U.S.C. 132(b) after a notice of allowance has been mailed. Moreover, the filing of a request for continued examination after the mailing of a notice of allowance removes the application from the issue process, prevents the Office from issuing the patent, and requires the Office to determine if the submission affects the patentability of the application, which adds to the pendency of the application in which the request for continued examination is filed (as well as other applications since examination resources must be diverted from other applications to the application in which the request for continued examination is filed). “An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as ‘engag[ing] in reasonable efforts to conclude processing or examination of an application’ (35 U.S.C. 154(b)(2)(C)(i)).” See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56379 (response to comment 17). Therefore, the Office considers it appropriate to expressly define the filing of a request for continued examination after the mailing of any notice of allowance as a failure to engage in reasonable efforts to conclude processing or examination of an application. See 35 U.S.C. 154(b)(2)(C)(iii) (provides for the Office to prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application).

37 CFR 1.704(c)(14) (which was formerly 37 CFR 1.704(c)(11), (c)(12), and (c)(13)) establishes further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Currently, a continuing application may be used to: (1) obtain further examination of an invention disclosed and claimed in the prior application (continuation application); (2) obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application (divisional application); or (3) obtain examination of an invention neither disclosed nor claimed in the prior application (continuation-in-part application). The provisions of 35 U.S.C. 132(b) and 37 CFR 1.114 permit an applicant to obtain further or continued examination of an invention disclosed and claimed in an application, which renders it unnecessary for an applicant whose application is eligible for patent term adjustment under 35 U.S.C. 154(b) to file a continuing application to obtain further examination of an invention disclosed and claimed in an application. If an applicant is filing a continuing application to obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application or an invention neither disclosed nor claimed in the prior application, it is not appropriate for that applicant to obtain any benefit in the continuing application for examination delays that might have occurred in the prior application. See Mohsenzadeh v. Lee, 790 F.3d 1377, 115 USPQ2d 1483 (Fed. Cir. 2015) where the district court upheld the Office’s position that patent term adjustment does not carry over to a continuing or divisional application. Thus, the Office has established further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in that the period of adjustment set forth in 37 CFR 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent. Thus, if the application that resulted in the patent is a continuing application (including a CPA), the period of adjustment set forth in 37 CFR 1.703 (if any) will not include any period that is prior to the actual filing date of the application (in the case of a CPA, the filing date of the request for a CPA) that resulted in the patent.

Effective March 10, 2015, 37 CFR 1.704(d)(1) was amended to also provide that a request for continued examination in compliance with 37 CFR 1.114 with no submission other than an information disclosure statement in compliance with 37 CFR 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(12), if the request for continued examination under 35 U.S.C. 132(b) is accompanied by the statement provided for in 37 CFR 1.704(d). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Thus, unless the information disclosure statement is accompanied by a safe harbor statement in compliance with 37 CFR 1.704(d), 37 CFR 1.704 provides for a reduction of any patent term adjustment if an information disclosure statement (1) is filed after a notice of allowance or after an initial reply by the applicant; or (2) is filed as a preliminary paper or paper after a decision by the Board or federal court that requires the USPTO to issue a supplemental Office action. Similarly, unless the submission for a request for continued examination after a notice of allowance has been mailed is solely an information disclosure statement and it is accompanied by a safe harbor statement in compliance with 37 CFR 1.704(d), 37 CFR 1.704 provides for a reduction of any patent term adjustment if a request for continued examination is filed after the mailing of a notice of allowance.

Effective March 10, 2015, 37 CFR 1.704(d)(1) was amended to also provide that a request for continued examination in compliance with 37 CFR 1.114 with no submission other than an information disclosure statement in compliance with 37 CFR 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(12), if the request for continued examination under 35 U.S.C. 132(b) is accompanied by the statement provided for in 37 CFR 1.704(d). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Thus, unless the information disclosure statement is accompanied by a safe harbor statement in compliance with 37 CFR 1.704(d), 37 CFR 1.704 provides for a reduction of any patent term adjustment if an information disclosure statement (1) is filed after a notice of allowance or after an initial reply by the applicant; or (2) is filed as a preliminary paper or paper after a decision by the Board or federal court that requires the USPTO to issue a supplemental Office action. Similarly, unless the submission for a request for continued examination after a notice of allowance has been mailed is solely an information disclosure statement and it is accompanied by a safe harbor statement in compliance with 37 CFR 1.704(d), 37 CFR 1.704 provides for a reduction of any patent term adjustment if a request for continued examination is filed after the mailing of a notice of allowance.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

37 CFR 1.704(c)(6) establishes submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 that requires the mailing of a supplemental Office action or notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. If the submission of a preliminary amendment or other paper requires the Office to issue a supplemental Office action or notice of allowance, the submission of that preliminary amendment or other paper has interfered with the processing and examination of an application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(6) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is eight months from either the date on which the application was filed under 35 U.S.C. 111(a) or the date of commencement of the national stage under 35 U.S.C. 371(b) or (f) in an international application and ending on the date the preliminary amendment or other preliminary paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the date of mailing of the supplemental Office action or notice of allowance or four months. The phrase “lesser of… or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(6) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance.

37 CFR 1.704(c)(9) establishes submission of an amendment or other paper (other than a statement under 37 CFR 41.50(c)) in an application after a decision by the Patent Trial and Appeal Board (other than a decision containing a rejection under 37 CFR 41.50(b)) or a federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151, that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of an amendment or other paper (e.g., IDS or petition) in an application after a Board decision or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office’s taking action on the application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(9) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a federal court and ending on the date the amendment or other paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance or four months. The phrase “lesser of…or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(9) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance. If the amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for OPSG to flag in the patent term adjustment calculation.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

[Editor Note: 37 CFR 1.704(d)(3) only applies for statements under 37 CFR 1.704(d) filed on or after July 17, 2023. 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10), as reproduced below, include changes applicable only to original utility and plant patents issuing from applications filed on or after May 29, 2000, in which a notice of allowance was mailed on or after July 16, 2020. For 37 CFR 1.704(c)(2)-(4), (c)(6), and (c)(9)-(10) in effect for applications filed on or after May 29, 2000, in which there was no notice of allowance mailed on or after July 16, 2020, see 37 CFR 1.704 (2015‑03‑10 thru 2020‑07‑15). 37 CFR 1.704(c)(12), as reproduced below, include changes applicable only to applications in which a request for continued examination under 35 U.S.C. 132(b) and 37 CFR 1.114 was filed on or after March 10, 2015. In addition, 37 CFR 1.704(c)(11), (c)(13), and (c)(14), as reproduced below, include changes applicable only to patent applications filed under 35 U.S.C. 111 on or after December 18, 2013, and to international patent applications in which the national stage commenced under 35 U.S.C. 371 on or after December 18, 2013. For 37 CFR 1.704(c)(11) and (c)(12) in effect for applications filed before (and international applications in which the national stage commenced before) December 18, 2013, and in which a notice of appeal was filed on or after September 17, 2012, see 37 CFR 1.704 (2012-09-17 thru 2013-12-17). For 37 CFR 1.704(c)(11) in effect for applications in which there was a notice of appeal filed prior to September 17, 2012, see 37 CFR 1.704(c)(11) (pre-2012-09-17). 37 CFR 1.704(e) below includes changes applicable only to applications in which a notice of allowance was mailed on or after April 1, 2013. For 37 CFR 1.704(e) in effect for applications in which no notice of allowance mailed on or after April 1, 2013, see 37 CFR 1.704(e) (pre-2013-03-31).]

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

Effective for applications in which a notice of appeal was filed on or after September 17, 2012, 37 CFR 1.704(c)(11) establishes that failure to file an appeal brief in compliance with 37 CFR 41.37 within three months from the date on which a notice of appeal to the Patent Trial and Appeal Board was filed under 35 U.S.C. 134 and 37 CFR 41.31 is a circumstance that constitutes a failure to engage in reasonable efforts to conclude processing or examination of the application. It is noted that although the appeal brief is due within two months of the filing of the notice of appeal under 37 CFR 41.37, 37 CFR 1.704(c)(11) provides three months before any patent term adjustment under 37 CFR 1.703 will be reduced for the late submission of an appeal brief. If applicant files a non-compliant appeal brief and thereafter files a compliant appeal brief, the period of time from the filing of a non-compliant appeal brief to the filing of the compliant appeal brief will not be considered a failure to engage in reasonable efforts to conclude processing or examination of the application under 37 CFR 1.704(c)(8). However, if the compliant appeal brief is filed more than three months from the date on which the notice of appeal was filed, the provisions of 37 CFR 1.704(c)(11) may result in reduction of any patent term adjustment under 37 CFR 1.703. 37 CFR 1.704(c)(11) provides that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date three months from the date on which the notice of appeal to the Patent Trial and Appeal Board was filed and ending on the date an appeal brief in compliance with 37 CFR 41.37 or a request for continued examination in compliance with 37 CFR 1.114 was filed.

If the Office reopens prosecution of the application more than three months after the filing of the notice of appeal but prior to the submission of a compliant appeal brief, the Office will not deem the period of time from the day after three months from the filing of the notice of appeal to the date the Office reopens prosecution to be an applicant delay under 37 CFR 1.704(c)(11). In addition, the Office’s reopening of prosecution after appeal will not be considered as vacating any previous response that potentially increases patent term adjustment under 35 U.S.C. 154(b)(1)(A)(i) through (iv). As discussed above, the change to 37 CFR 1.704(c)(11) is applicable to any applications that includes an appeal brief in which the notice of appeal was filed on or after September 17, 2012.

If the Office reopens prosecution of the application more than three months after the filing of the notice of appeal but prior to the submission of a compliant appeal brief, the Office will not deem the period of time from the day after three months from the filing of the notice of appeal to the date the Office reopens prosecution to be an applicant delay under 37 CFR 1.704(c)(11). In addition, the Office’s reopening of prosecution after appeal will not be considered as vacating any previous response that potentially increases patent term adjustment under 35 U.S.C. 154(b)(1)(A)(i) through (iv). As discussed above, the change to 37 CFR 1.704(c)(11) is applicable to any applications that includes an appeal brief in which the notice of appeal was filed on or after September 17, 2012.

(b) With respect to the grounds for adjustment set forth in §§ 1.702(a) through (e), and in particular the ground of adjustment set forth in § 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is three months after the date of mailing or transmission of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. The period, or shortened statutory period, for reply that is set in the Office action or notice has no effect on the three-month period set forth in this paragraph.

(b) With respect to the grounds for adjustment set forth in §§ 1.702(a) through (e), and in particular the ground of adjustment set forth in § 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is three months after the date of mailing or transmission of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. The period, or shortened statutory period, for reply that is set in the Office action or notice has no effect on the three-month period set forth in this paragraph.

37 CFR 1.704(b) provides that with respect to the ground for adjustments set forth in 37 CFR 1.702(a) through (e), and in particular 37 CFR 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude prosecution for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant. A Notice of Omitted Items in a Nonprovisional Application, however, is not a notice or action by the Office making a rejection, objection, argument, or other request within the meaning of 35 U.S.C. 154(b)(2)(C)(ii) or 37 CFR 1.704(b), since the Office does not require a reply to that notice to continue the processing and examination of an application. 37 CFR 1.704(b) indicates that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is three months after the date of mailing or transmission of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. As discussed above, a reply is considered filed on the date of its actual receipt in the Office as defined by 37 CFR 1.6, and the date indicated on any certificate of mailing or transmission under 37 CFR 1.8 will not be taken into account for patent term adjustment purposes.

37 CFR 1.704(b) provides that with respect to the ground for adjustments set forth in 37 CFR 1.702(a) through (e), and in particular 37 CFR 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude prosecution for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant. A Notice of Omitted Items in a Nonprovisional Application, however, is not a notice or action by the Office making a rejection, objection, argument, or other request within the meaning of 35 U.S.C. 154(b)(2)(C)(ii) or 37 CFR 1.704(b), since the Office does not require a reply to that notice to continue the processing and examination of an application. 37 CFR 1.704(b) indicates that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is three months after the date of mailing or transmission of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. As discussed above, a reply is considered filed on the date of its actual receipt in the Office as defined by 37 CFR 1.6, and the date indicated on any certificate of mailing or transmission under 37 CFR 1.8 will not be taken into account for patent term adjustment purposes.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

Applicant’s submission of an information disclosure statement pursuant to 37 CFR 1.97(c) or an amendment under 37 CFR 41.33 after a notice of appeal has been filed but prior to jurisdiction passing to the Patent Trial and Appeal Board is deemed an applicant delay under 37 CFR 1.704(c)(8). Under 37 CFR 1.97(c), an applicant who submits an information disclosure statement meeting the requirements of 37 CFR 1.97 and 1.98 will have such submission considered by the examiner if it is accompanied by a statement under 37 CFR 1.97(e) and the fee under 37 CFR 1.17(p). Moreover, the Office may admit an amendment after notice of appeal if it meets the applicable requirements in 37 CFR 41.33(a) and (b) for consideration. Because the treatment of these papers may delay the Board taking jurisdiction of the application, the Office will treat such papers similarly to how the Office treats a supplemental reply under this provision, in that the papers will be considered as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.

37 CFR 1.704(c)(9) establishes submission of an amendment or other paper (other than a statement under 37 CFR 41.50(c)) in an application after a decision by the Patent Trial and Appeal Board (other than a decision containing a rejection under 37 CFR 41.50(b)) or a federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151, that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of an amendment or other paper (e.g., IDS or petition) in an application after a Board decision or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office’s taking action on the application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(9) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a federal court and ending on the date the amendment or other paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance or four months. The phrase “lesser of…or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(9) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance. If the amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for OPSG to flag in the patent term adjustment calculation.

37 CFR 1.704(c)(9) establishes submission of an amendment or other paper (other than a statement under 37 CFR 41.50(c)) in an application after a decision by the Patent Trial and Appeal Board (other than a decision containing a rejection under 37 CFR 41.50(b)) or a federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151, that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of an amendment or other paper (e.g., IDS or petition) in an application after a Board decision or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office’s taking action on the application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(9) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a federal court and ending on the date the amendment or other paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance or four months. The phrase “lesser of…or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(9) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance. If the amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for OPSG to flag in the patent term adjustment calculation.

37 CFR 1.704(c)(9) establishes submission of an amendment or other paper (other than a statement under 37 CFR 41.50(c)) in an application after a decision by the Patent Trial and Appeal Board (other than a decision containing a rejection under 37 CFR 41.50(b)) or a federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151, that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of an amendment or other paper (e.g., IDS or petition) in an application after a Board decision or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office’s taking action on the application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(9) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a federal court and ending on the date the amendment or other paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance or four months. The phrase “lesser of…or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(9) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance. If the amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for OPSG to flag in the patent term adjustment calculation.

For any application having a notice of allowance mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) is also amended to exclude ‘‘an amendment under § 1.312 or other paper expressly requested by the Office’’ from the amendments under 37 CFR 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). Thus, an amendment under 37 CFR 1.312 or other paper not expressly requested by the Office (i.e., a ‘‘voluntary’’ amendment under 37 CFR 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). An amendment under 37 CFR 1.312 or other paper going beyond what was requested by the Office (i.e., including material not expressly requested by the Office in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under 37 CFR 1.704(c)(10). In addition, the phrase ‘‘expressly requested by the Office’’ requires a specific request in an Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B), for the amendment under 37 CFR 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). Similarly, the provisions of 37 CFR 1.56, 1.97 and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). An information disclosure statement in compliance with 37 CFR 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under 37 CFR 1.704(c)(10) (or 37 CFR 1.704(c)(6), (8), or (9)) if the information disclosure statement is accompanied by a statement under 37 CFR 1.704(d). Finally, an amendment under 37 CFR 1.312 or other paper expressly requested by the Office not filed within three months from the date of mailing of the Office communication notifying the applicant of such request will result in a reduction of patent term adjustment under 37 CFR 1.704(b).

For any application having a notice of allowance mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) is also amended to exclude ‘‘an amendment under § 1.312 or other paper expressly requested by the Office’’ from the amendments under 37 CFR 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). Thus, an amendment under 37 CFR 1.312 or other paper not expressly requested by the Office (i.e., a ‘‘voluntary’’ amendment under 37 CFR 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). An amendment under 37 CFR 1.312 or other paper going beyond what was requested by the Office (i.e., including material not expressly requested by the Office in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under 37 CFR 1.704(c)(10). In addition, the phrase ‘‘expressly requested by the Office’’ requires a specific request in an Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B), for the amendment under 37 CFR 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). Similarly, the provisions of 37 CFR 1.56, 1.97 and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). An information disclosure statement in compliance with 37 CFR 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under 37 CFR 1.704(c)(10) (or 37 CFR 1.704(c)(6), (8), or (9)) if the information disclosure statement is accompanied by a statement under 37 CFR 1.704(d). Finally, an amendment under 37 CFR 1.312 or other paper expressly requested by the Office not filed within three months from the date of mailing of the Office communication notifying the applicant of such request will result in a reduction of patent term adjustment under 37 CFR 1.704(b).

For any application having a notice of allowance mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) is also amended to exclude ‘‘an amendment under § 1.312 or other paper expressly requested by the Office’’ from the amendments under 37 CFR 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). Thus, an amendment under 37 CFR 1.312 or other paper not expressly requested by the Office (i.e., a ‘‘voluntary’’ amendment under 37 CFR 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). An amendment under 37 CFR 1.312 or other paper going beyond what was requested by the Office (i.e., including material not expressly requested by the Office in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under 37 CFR 1.704(c)(10). In addition, the phrase ‘‘expressly requested by the Office’’ requires a specific request in an Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B), for the amendment under 37 CFR 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). Similarly, the provisions of 37 CFR 1.56, 1.97 and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). An information disclosure statement in compliance with 37 CFR 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under 37 CFR 1.704(c)(10) (or 37 CFR 1.704(c)(6), (8), or (9)) if the information disclosure statement is accompanied by a statement under 37 CFR 1.704(d). Finally, an amendment under 37 CFR 1.312 or other paper expressly requested by the Office not filed within three months from the date of mailing of the Office communication notifying the applicant of such request will result in a reduction of patent term adjustment under 37 CFR 1.704(b).
For example , generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10).

37 CFR 1.704(b) provides that with respect to the ground for adjustments set forth in 37 CFR 1.702(a) through (e), and in particular 37 CFR 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude prosecution for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant. A Notice of Omitted Items in a Nonprovisional Application, however, is not a notice or action by the Office making a rejection, objection, argument, or other request within the meaning of 35 U.S.C. 154(b)(2)(C)(ii) or 37 CFR 1.704(b), since the Office does not require a reply to that notice to continue the processing and examination of an application. 37 CFR 1.704(b) indicates that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is three months after the date of mailing or transmission of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. As discussed above, a reply is considered filed on the date of its actual receipt in the Office as defined by 37 CFR 1.6, and the date indicated on any certificate of mailing or transmission under 37 CFR 1.8 will not be taken into account for patent term adjustment purposes.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

37 CFR 1.704(c)(8) establishes submission of a supplemental reply or other paper after a reply has been filed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of a supplemental reply or other paper (e.g., an information disclosure statement (IDS) or petition) after an initial reply was filed requires the Office to restart consideration of the initial reply in view of the supplemental reply or other paper, which will result in a delay in the Office’s response to the initial reply. The submission of an information disclosure statement that is filed after a reply to a restriction requirement (and prior to the subsequent Office action and without a safe harbor statement under 37 CFR 1.704(d)) is an applicant delay. See Gilead Sciences Inc. v. Lee, 778 F.3d 1341, 113 USPQ2d 1837 (Fed. Cir. 2015). Similarly, the filing of an information disclosure statement after a request for continued examination (RCE) but prior to a subsequent Office action is deemed an applicant delay under 37 CFR 1.704(c)(8). 37 CFR 1.704(c)(8) does not apply to a supplemental reply or other paper that was expressly requested by the examiner. In addition, the Office cannot reduce patent term adjustment in the rare situation for “a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution.” Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 1359, 129 USPQ2d 1240 (Fed. Cir. 2019) (the court found applicant delay for the period between the filing of the RCE and the issuance of European Patent Office communication, which was the basis for the later-filed Information Disclosure Statement, is not a permissible reduction in patent term adjustment because there is no identifiable effort in which the applicant could have engaged to conclude prosecution during this time period.). If applicant believes that the Office has reduced the patent term adjustment for a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prosecution, a timely request for reconsideration in compliance with 37 CFR 1.705(b) may be filed to request correction of the patent term adjustment determination.

37 CFR 1.704(c)(3) establishes abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if the application is abandoned (either by failure to prosecute or late payment of the issue fee), the Office is precluded from processing or examining the application as a result of an action or inaction by the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(3) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due, and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due, and ending on the earlier of: (1) the date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (2) the date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed. The phrase “earlier of… [t]he date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed” is to place a cap (measured from the filing date of the grantable petition) on the reduction if the Office does not act on (grant) the grantable petition to revive within four months of the date it was filed.

37 CFR 1.704(c)(3) establishes abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if the application is abandoned (either by failure to prosecute or late payment of the issue fee), the Office is precluded from processing or examining the application as a result of an action or inaction by the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(3) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due, and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due, and ending on the earlier of: (1) the date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (2) the date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed. The phrase “earlier of… [t]he date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed” is to place a cap (measured from the filing date of the grantable petition) on the reduction if the Office does not act on (grant) the grantable petition to revive within four months of the date it was filed.

37 CFR 1.704(c)(3) establishes abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if the application is abandoned (either by failure to prosecute or late payment of the issue fee), the Office is precluded from processing or examining the application as a result of an action or inaction by the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(3) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due, and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due, and ending on the earlier of: (1) the date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (2) the date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed. The phrase “earlier of… [t]he date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed” is to place a cap (measured from the filing date of the grantable petition) on the reduction if the Office does not act on (grant) the grantable petition to revive within four months of the date it was filed.

37 CFR 1.704(c)(3) establishes abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if the application is abandoned (either by failure to prosecute or late payment of the issue fee), the Office is precluded from processing or examining the application as a result of an action or inaction by the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(3) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due, and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due, and ending on the earlier of: (1) the date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (2) the date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed. The phrase “earlier of… [t]he date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed” is to place a cap (measured from the filing date of the grantable petition) on the reduction if the Office does not act on (grant) the grantable petition to revive within four months of the date it was filed.

37 CFR 1.704(c)(3) establishes abandonment of the application or late payment of the issue fee as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if the application is abandoned (either by failure to prosecute or late payment of the issue fee), the Office is precluded from processing or examining the application as a result of an action or inaction by the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(3) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date of abandonment or the day after the date the issue fee was due, and ending on the date the grantable petition to revive the application or accept late payment of the issue fee was filed. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date of abandonment or the date after the date the issue fee was due, and ending on the earlier of: (1) the date of mailing of the decision reviving the application or accepting late payment of the issue fee; or (2) the date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed. The phrase “earlier of… [t]he date that is four months after the date the grantable petition to revive the application or accept late payment of the issue fee was filed” is to place a cap (measured from the filing date of the grantable petition) on the reduction if the Office does not act on (grant) the grantable petition to revive within four months of the date it was filed.

Nevertheless, the Office considers it appropriate to permit applicants to submit information cited in a patent office communication in a counterpart application to the Office without a reduction in patent term adjustment if an information disclosure statement is submitted to the Office within thirty days (not three months) of the date the patent office communication was received by an individual designated in 37 CFR 1.56(c). Accordingly, 37 CFR 1.704(d) was revised to provide that a request for continued examination in compliance with 37 CFR 1.114 with no submission other than an information disclosure statement in compliance with 37 CFR 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(12), if the request for continued examination is accompanied by a statement in compliance with 37 CFR 1.704(d).

The determination of when the thirty day period in 37 CFR 1.704(d)(1)(i) or (ii) begins to run is dependent on the role of each entity involved in the prosecution of the U.S. and foreign applications, and the role that each plays (if any) vis-à-vis the application being examined by the USPTO. The inventors, the assignee and the U.S. patent counsel are all individuals designated in 37 CFR 1.56(c). The issue is whether the foreign patent counsel is also an individual designated in 37 CFR 1.56(c).

37 CFR 1.56(c) provides that individuals associated with the filing or prosecution of a patent application within the meaning of 37 CFR 1.56 are:

• 1. Each inventor named in the application;
• 2. Each attorney or agent who prepares or prosecutes the application; and
• 3. Every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation to assign the application.

In this example, the foreign counsel has no substantive role in the prosecution of the U.S. application. The explicitly defined role of the foreign counsel relative to the U.S. counsel in combination with the practice in the described fact pattern removes any potential doubt as to the role of the foreign counsel. For these reasons, the foreign counsel is not deemed a person who is substantially involved in the U.S. application under 37 CFR 1.56(c).

In this example, the USPTO would consider the French counsel to have been a party within the meaning of 37 CFR 1.56(c). The French counsel, based on the above facts, played a substantive role in the preparation and prosecution of the U.S. application (e.g., the French counsel drafted the original application, worked with U.S. counsel to edit the application and subsequently amended the EPO application based on the work product produced with U.S. counsel).

37 CFR 1.704 implements the provisions of 35 U.S.C. 154(b)(2)(C) which provides that the period of patent term adjustment under 35 U.S.C. 154(b)(1) “shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution (processing or examination) of the application,” and specifies certain circumstances as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Further, 35 U.S.C. 154(b)(2)(C)(iii) gives the Office the authority to prescribe regulations establishing circumstances that constitute “a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. 154(b)(2)(C) does not require the applicant’s action or inaction (that amounts to a failure to engage in reasonable efforts to conclude prosecution of the application) to have caused or contributed to patent term adjustment for the period of adjustment to be reduced due to such action or inaction. The patent term adjustment provisions of 35 U.S.C. 154(b) create a balanced system allowing for patent term adjustment due to Office delays for a reasonably diligent applicant. Since the public has an interest in the technology disclosed and covered by a patent being available to the public at the earliest possible date, 35 U.S.C. 154(b)(2)(C)(i) provides that patent term adjustment is reduced by any period of time during which applicant failed to engage in reasonable efforts to conclude prosecution of the application, regardless of whether the applicant’s actions or inactions caused or contributed to patent term adjustment.

37 CFR 1.704(c) establishes further circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. 37 CFR 1.704(c)(1) through (c)(13) set forth actions or inactions by an applicant that interfere with the Office’s ability to process or examine an application (and, thus, are circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application), as well as the period by which a period of adjustment set forth in 37 CFR 1.703 shall be reduced if an applicant engages in any of the enumerated actions or inactions. 37 CFR 1.704(c) requires that an applicant refrain from engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application. An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as “engag[ing] in reasonable efforts to conclude processing or examination of an application” (35 U.S.C. 154(b)(2)(C)(i)). A reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application. Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351, 129 USPQ2d 1240 (Fed. Cir. 2019).

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, 37 CFR 1.704(c)(12) was amended to provide a new provision that establishes the submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed as constituting a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in which case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed. See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). This provision ensures that an applicant does not obtain additional patent term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance has been mailed as a consequence of delaying issuance of the patent by filing a request for continued examination under 35 U.S.C. 132(b) after a notice of allowance has been mailed. Moreover, the filing of a request for continued examination after the mailing of a notice of allowance removes the application from the issue process, prevents the Office from issuing the patent, and requires the Office to determine if the submission affects the patentability of the application, which adds to the pendency of the application in which the request for continued examination is filed (as well as other applications since examination resources must be diverted from other applications to the application in which the request for continued examination is filed). “An applicant who is engaging in actions or inactions that prevent or interfere with the Office’s ability to process or examine an application cannot reasonably be characterized as ‘engag[ing] in reasonable efforts to conclude processing or examination of an application’ (35 U.S.C. 154(b)(2)(C)(i)).” See Changes to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56379 (response to comment 17). Therefore, the Office considers it appropriate to expressly define the filing of a request for continued examination after the mailing of any notice of allowance as a failure to engage in reasonable efforts to conclude processing or examination of an application. See 35 U.S.C. 154(b)(2)(C)(iii) (provides for the Office to prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application).

37 CFR 1.704(c)(14) (which was formerly 37 CFR 1.704(c)(11), (c)(12), and (c)(13)) establishes further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Currently, a continuing application may be used to: (1) obtain further examination of an invention disclosed and claimed in the prior application (continuation application); (2) obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application (divisional application); or (3) obtain examination of an invention neither disclosed nor claimed in the prior application (continuation-in-part application). The provisions of 35 U.S.C. 132(b) and 37 CFR 1.114 permit an applicant to obtain further or continued examination of an invention disclosed and claimed in an application, which renders it unnecessary for an applicant whose application is eligible for patent term adjustment under 35 U.S.C. 154(b) to file a continuing application to obtain further examination of an invention disclosed and claimed in an application. If an applicant is filing a continuing application to obtain examination (for the first time) of an invention disclosed but not claimed or not elected for examination in the prior application or an invention neither disclosed nor claimed in the prior application, it is not appropriate for that applicant to obtain any benefit in the continuing application for examination delays that might have occurred in the prior application. See Mohsenzadeh v. Lee, 790 F.3d 1377, 115 USPQ2d 1483 (Fed. Cir. 2015) where the district court upheld the Office’s position that patent term adjustment does not carry over to a continuing or divisional application. Thus, the Office has established further prosecution via a continuing application as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application, in that the period of adjustment set forth in 37 CFR 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent. Thus, if the application that resulted in the patent is a continuing application (including a CPA), the period of adjustment set forth in 37 CFR 1.703 (if any) will not include any period that is prior to the actual filing date of the application (in the case of a CPA, the filing date of the request for a CPA) that resulted in the patent.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

37 CFR 1.704(c)(2) establishes deferral of issuance of a patent under 37 CFR 1.314 as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Obviously, if issuance of the patent is deferred under 37 CFR 1.314, the Office is precluded from issuing the application as a result of an action by the applicant. When a petition under 37 CFR 1.314 is granted, the petition decision generally states that the application will be held for a period of a month to await the filing of a paper. At the end of the period, the application is returned to the issue process without a further communication from the Office to the applicant. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(2) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the earlier of the date a request to terminate the deferral was filed or the date the patent was issued. To request termination of the deferral, the applicant should file a petition under 37 CFR 1.182 to request termination of the deferral of the issuance of the patent, and therefore, end the period of reduction under 37 CFR 1.704(c)(2) prior to the issuance of the patent. For all other applications, the period of adjustment shall be reduced by the number of days, if any, beginning on the date a request for deferral of issuance of a patent under 37 CFR 1.314 was filed and ending on the issue date of the patent.

Use of form PTO/SB/133 was not required for safe harbor statements filed before July 17, 2023. However, safe harbor statements under 37 CFR 1.704(d) filed on or after July 17, 2023, must be submitted on form PTO/SB/133 using the document code PTA.IDS. See 37 CFR 1.704(d)(3). The form is available on the USPTO’s website at (www.uspto.gov/PatentForms) and is reproduced below at the end of this section. The Office of Management and Budget (OMB) has determined that, under 5 CFR 1320.3(h), form PTO/SB/133 does not collect “information” within the meaning of the Paperwork Reduction Act of 1995.

The determination of when the thirty day period in 37 CFR 1.704(d)(1)(i) or (ii) begins to run is dependent on the role of each entity involved in the prosecution of the U.S. and foreign applications, and the role that each plays (if any) vis-à-vis the application being examined by the USPTO. The inventors, the assignee and the U.S. patent counsel are all individuals designated in 37 CFR 1.56(c). The issue is whether the foreign patent counsel is also an individual designated in 37 CFR 1.56(c).

The determination of when the thirty day period in 37 CFR 1.704(d)(1)(i) or (ii) begins to run is dependent on the role of each entity involved in the prosecution of the U.S. and foreign applications, and the role that each plays (if any) vis-à-vis the application being examined by the USPTO. The inventors, the assignee and the U.S. patent counsel are all individuals designated in 37 CFR 1.56(c). The issue is whether the foreign patent counsel is also an individual designated in 37 CFR 1.56(c).

In this example, the foreign counsel has no substantive role in the prosecution of the U.S. application. The explicitly defined role of the foreign counsel relative to the U.S. counsel in combination with the practice in the described fact pattern removes any potential doubt as to the role of the foreign counsel. For these reasons, the foreign counsel is not deemed a person who is substantially involved in the U.S. application under 37 CFR 1.56(c).

In this example, the USPTO would consider the French counsel to have been a party within the meaning of 37 CFR 1.56(c). The French counsel, based on the above facts, played a substantive role in the preparation and prosecution of the U.S. application (e.g., the French counsel drafted the original application, worked with U.S. counsel to edit the application and subsequently amended the EPO application based on the work product produced with U.S. counsel).

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

In addition, the three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) applies regardless of the period for reply set in the Office action or notice. For example, if an Office action sets a two-month period for reply (restriction requirement), the applicant may obtain a one-month extension of time under 37 CFR 1.136(a) before being subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b). If, however, an Office action sets a six-month period for reply, as is commonly set in applications subject to secrecy orders (see MPEP § 130), the applicant is subject to a reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and 37 CFR 1.704(b) if the applicant does not reply to the Office action within three months, notwithstanding that a reply may be timely filed six months after the mailing date of the Office action. If the last day of the three-month time period from the Office communication notifying the applicant of the rejection, objection, argument, or other request falls on a Saturday, Sunday, or federal holiday within the District of Columbia, then action, may be taken, or fee paid, on the next succeeding secular or business day without loss of any patent term adjustment under 37 CFR 1.704(b). See ArQule v. Kappos, 793 F.Supp2d 214 (D.D.C. 2011). For example, no reduction in patent term adjustment would occur if an applicant’s three-month reply time period expires on a Saturday and the applicant files a reply that is received by the Office on the following Monday, which is not a federal holiday within the District of Columbia. In this case, any patent term adjustment would not be reduced under 37 CFR 1.704(b) because the reply was received on Monday, the next succeeding secular or business day after the expiration of the three-month reply time. If applicant files the reply on Tuesday, then any patent term adjustment for the patent issuing from the application would be reduced under 37 CFR 1.704(b) by one day.

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).
Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019) Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination.

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

37 CFR 1.704(c)(5) establishes conversion of a provisional application under 35 U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 111(a) (pursuant to 35 U.S.C. 111(b)(5); (see MPEP § 201.04)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Conversion of a provisional application to a nonprovisional application will require the Office to reprocess the application (as a nonprovisional application) up to one year after the filing date that will be accorded to such nonprovisional application as a result of an action by the applicant. 37 CFR 1.704(c)(5) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date the application was filed under 35 U.S.C. 111(b) and ending on the date a request in compliance with 37 CFR 1.53(c)(3) to convert the provisional application into a nonprovisional application was filed.

37 CFR 1.704(c)(5) establishes conversion of a provisional application under 35 U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 111(a) (pursuant to 35 U.S.C. 111(b)(5); (see MPEP § 201.04)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Conversion of a provisional application to a nonprovisional application will require the Office to reprocess the application (as a nonprovisional application) up to one year after the filing date that will be accorded to such nonprovisional application as a result of an action by the applicant. 37 CFR 1.704(c)(5) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date the application was filed under 35 U.S.C. 111(b) and ending on the date a request in compliance with 37 CFR 1.53(c)(3) to convert the provisional application into a nonprovisional application was filed.

37 CFR 1.704(c)(5) establishes conversion of a provisional application under 35 U.S.C. 111(b) to a nonprovisional application under 35 U.S.C. 111(a) (pursuant to 35 U.S.C. 111(b)(5); (see MPEP § 201.04)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Conversion of a provisional application to a nonprovisional application will require the Office to reprocess the application (as a nonprovisional application) up to one year after the filing date that will be accorded to such nonprovisional application as a result of an action by the applicant. 37 CFR 1.704(c)(5) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the date the application was filed under 35 U.S.C. 111(b) and ending on the date a request in compliance with 37 CFR 1.53(c)(3) to convert the provisional application into a nonprovisional application was filed.

If an amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for One Patent Service Gateway (OPSG) to flag in the patent term adjustment calculation. 37 CFR 1.704(c)(8) also provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the initial reply was filed and ending on the date that the supplemental reply or such other paper was filed.

37 CFR 1.704(d)(1) requires that the information disclosure statement “is accompanied by” the safe harbor statement. In other words, the safe harbor statement must be filed concurrently with (therefore, on the same date as) the information disclosure statement according to 37 CFR 1.704(d)(1). However, the Office has provided a procedure for applicants to seek a waiver using a 37 CFR 1.183 petition to allow for a late-filed statement under 37 CFR 1.704. If an applicant submits an information disclosure statement within the 30-day period set forth in 37 CFR 1.704(d)(1) but does not include a statement under 37 CFR 1.704 with the information disclosure statement (therefore, not filed on the same date), the applicant should consider filing a request for reconsideration of the patent term adjustment indicated on the patent (37 CFR 1.705(b)), along with a statement under 37 CFR 1.704(d) (if not previously filed) and petition under 37 CFR 1.183 (along with the fee under 37 CFR 1.17(f)) requesting that the Office consider the statement under 37 CFR 1.704(d) when making the patent term adjustment determination. Applicants should keep in mind that a petition under 37 CFR 1.183 may only be used to request acceptance of the late-filed statement under 37 CFR 1.704(d). Under no circumstances will an information disclosure statement filed more than 30 days from the applicable communication under 37 CFR 1.704(d)(1)(i) or (ii) be treated as filed within the “safe harbor” of 37 CFR 1.704(d). In addition, the 30-day period in 37 CFR 1.704(d)(1) is not extendable. See 37 CFR 1.704(d)(2).

In order to aid the Office in recognizing when a compliant safe harbor statement under 37 CFR 1.704(d) has been filed with an information disclosure statement, the Office has created a form PTO/SB/133 “Patent Term Adjustment Statement under 37 CFR 1.704(d)” for applicant’s use when submitting the information disclosure statement. The Office has also updated the patent term adjustment computer program to recognize that form PTO/SB/133 has been filed concurrently with (therefore, on the same date as) the information disclosure statement using document code PTA.IDS. When form PTO/SB/133 is recognized, the patent term adjustment computer program will perform the patent term calculation by taking into account that applicant filed a compliant safe harbor statement under 37 CFR 1.704(d).

For any application having a notice of allowance mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) is also amended to exclude ‘‘an amendment under § 1.312 or other paper expressly requested by the Office’’ from the amendments under 37 CFR 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). Thus, an amendment under 37 CFR 1.312 or other paper not expressly requested by the Office (i.e., a ‘‘voluntary’’ amendment under 37 CFR 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). An amendment under 37 CFR 1.312 or other paper going beyond what was requested by the Office (i.e., including material not expressly requested by the Office in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under 37 CFR 1.704(c)(10). In addition, the phrase ‘‘expressly requested by the Office’’ requires a specific request in an Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B), for the amendment under 37 CFR 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). Similarly, the provisions of 37 CFR 1.56, 1.97 and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). An information disclosure statement in compliance with 37 CFR 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under 37 CFR 1.704(c)(10) (or 37 CFR 1.704(c)(6), (8), or (9)) if the information disclosure statement is accompanied by a statement under 37 CFR 1.704(d). Finally, an amendment under 37 CFR 1.312 or other paper expressly requested by the Office not filed within three months from the date of mailing of the Office communication notifying the applicant of such request will result in a reduction of patent term adjustment under 37 CFR 1.704(b).

The provision in 37 CFR 1.704(d) will permit applicants to submit information first cited in any communication from a patent office in a counterpart foreign or international application or from the Office in another application without a reduction in patent term adjustment if an information disclosure statement is promptly (within thirty days of receipt of the first communication) submitted to the Office. Specifically, information first cited in any communication from a foreign patent office or this Office and received by an individual designated in 37 CFR 1.56(c) more than thirty days before the filing of the information disclosure statement is not entitled to the safe harbor provision, even if the same information is once again cited by another foreign patent office or this Office within thirty days prior to the filing of the information disclosure statement in the Office. This is because the applicant was aware of the information more than thirty days before the filing of the information disclosure statement, yet did not submit that information. The term “any” in “any communication” was used in 37 CFR 1.704(d)(1)(i) to make the distinction clear. This provision also permits an applicant to submit communications that were issued by a patent office in a counterpart foreign or international application or by the Office that were not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement to avoid a reduction in any patent term adjustment. See 37 CFR 1.704(d)(1)(ii).

The provision in 37 CFR 1.704(d) will permit applicants to submit information first cited in any communication from a patent office in a counterpart foreign or international application or from the Office in another application without a reduction in patent term adjustment if an information disclosure statement is promptly (within thirty days of receipt of the first communication) submitted to the Office. Specifically, information first cited in any communication from a foreign patent office or this Office and received by an individual designated in 37 CFR 1.56(c) more than thirty days before the filing of the information disclosure statement is not entitled to the safe harbor provision, even if the same information is once again cited by another foreign patent office or this Office within thirty days prior to the filing of the information disclosure statement in the Office. This is because the applicant was aware of the information more than thirty days before the filing of the information disclosure statement, yet did not submit that information. The term “any” in “any communication” was used in 37 CFR 1.704(d)(1)(i) to make the distinction clear. This provision also permits an applicant to submit communications that were issued by a patent office in a counterpart foreign or international application or by the Office that were not received by any individual designated in 37 CFR 1.56(c) more than thirty days prior to the filing of the information disclosure statement to avoid a reduction in any patent term adjustment. See 37 CFR 1.704(d)(1)(ii).

37 CFR 1.56(c) provides that individuals associated with the filing or prosecution of a patent application within the meaning of 37 CFR 1.56 are:
…
3. Every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation to assign the application.

In this example, the USPTO would consider the participation of the German attorney in the prosecution and decision-making as to the relevance of the newly cited art vis-à-vis the previously cited three patents to be a substantive participation in the U.S. prosecution. As such, the German attorney would be considered by the USPTO to be a party covered by 37 CFR 1.56(c). Accordingly, evaluation of compliance with 37 CFR 1.704(d) would consider the date that the foreign counsel first learned of the fourth patent (i.e., the newly cited reference).

In this example, the USPTO would consider the participation of the German attorney in the prosecution and decision-making as to the relevance of the newly cited art vis-à-vis the previously cited three patents to be a substantive participation in the U.S. prosecution. As such, the German attorney would be considered by the USPTO to be a party covered by 37 CFR 1.56(c). Accordingly, evaluation of compliance with 37 CFR 1.704(d) would consider the date that the foreign counsel first learned of the fourth patent (i.e., the newly cited reference).

(f) An application filed under 35 U.S.C. 111(a) is in condition for examination when it includes a specification, including at least one claim and an abstract (§ 1.72(b)), and has papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, any English translation required by § 1.52(d) or § 1.57(a), a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), an inventor’s oath or declaration or an application data sheet containing the information specified in § 1.63(b), the basic filing fee (§ 1.16(a) or (c)), the search fee (§ 1.16(k) or (m)), the examination fee (§ 1.16(o) or (q)), any certified copy of the previously filed application required by § 1.57(a), and any application size fee required by the Office under § 1.16(s). An international application is in condition for examination when it has entered the national stage as defined in § 1.491(b), and includes a specification, including at least one claim and an abstract (§ 1.72(b)), and has papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), an inventor’s oath or declaration or an application data sheet containing the information specified in § 1.63(b), the search fee (§ 1.492(b)), the examination fee (§ 1.492(c)), and any application size fee required by the Office under § 1.492(j). An application shall be considered as having papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, and a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), or a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), for purposes of this paragraph (f) on the filing date of the latest reply (if any) correcting the papers, drawings, “Sequence Listing,” or “Sequence Listing XML” that is prior to the date of mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151, whichever occurs first.

(f) An application filed under 35 U.S.C. 111(a) is in condition for examination when it includes a specification, including at least one claim and an abstract (§ 1.72(b)), and has papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, any English translation required by § 1.52(d) or § 1.57(a), a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), an inventor’s oath or declaration or an application data sheet containing the information specified in § 1.63(b), the basic filing fee (§ 1.16(a) or (c)), the search fee (§ 1.16(k) or (m)), the examination fee (§ 1.16(o) or (q)), any certified copy of the previously filed application required by § 1.57(a), and any application size fee required by the Office under § 1.16(s). An international application is in condition for examination when it has entered the national stage as defined in § 1.491(b), and includes a specification, including at least one claim and an abstract (§ 1.72(b)), and has papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), an inventor’s oath or declaration or an application data sheet containing the information specified in § 1.63(b), the search fee (§ 1.492(b)), the examination fee (§ 1.492(c)), and any application size fee required by the Office under § 1.492(j). An application shall be considered as having papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, and a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), or a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), for purposes of this paragraph (f) on the filing date of the latest reply (if any) correcting the papers, drawings, “Sequence Listing,” or “Sequence Listing XML” that is prior to the date of mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151, whichever occurs first.

37 CFR 1.704(c)(7) establishes submission of a reply having an omission (e.g., 37 CFR 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under 37 CFR 1.135(c) and await and process the applicant’s reply to the action under 37 CFR 1.135(c) before the initial reply (as corrected) can be treated on its merits. In addition, 37 CFR 1.704(c)(7) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed. The reference to 37 CFR 1.135(c) is parenthetical because 37 CFR 1.704(c)(7) is not limited to Office actions under 37 CFR 1.135(c) but applies also when the Office issues any action or notice indicating that a reply has an omission which must be corrected: for example, (1) a decision on a petition under 37 CFR 1.47 dismissing the petition as lacking an item necessary to grant the petition; or (2) a notice indicating that the computer readable sequence listing submitted in an application filed on or after July 1, 2022, in reply to a previous notice relating to the requirements for patent applications containing nucleotide and/or amino acid sequence disclosures, does not comply with 37 CFR 1.831 et seq. The filing of a non-compliant appeal brief, however, will not be deemed an omission under 37 CFR 1.704(c)(7) if the notice of appeal was filed on or after September 17, 2012. This situation is covered under 37 CFR 1.704(c)(11).

Effective for applications in which a notice of appeal was filed on or after September 17, 2012, 37 CFR 1.704(c)(11) establishes that failure to file an appeal brief in compliance with 37 CFR 41.37 within three months from the date on which a notice of appeal to the Patent Trial and Appeal Board was filed under 35 U.S.C. 134 and 37 CFR 41.31 is a circumstance that constitutes a failure to engage in reasonable efforts to conclude processing or examination of the application. It is noted that although the appeal brief is due within two months of the filing of the notice of appeal under 37 CFR 41.37, 37 CFR 1.704(c)(11) provides three months before any patent term adjustment under 37 CFR 1.703 will be reduced for the late submission of an appeal brief. If applicant files a non-compliant appeal brief and thereafter files a compliant appeal brief, the period of time from the filing of a non-compliant appeal brief to the filing of the compliant appeal brief will not be considered a failure to engage in reasonable efforts to conclude processing or examination of the application under 37 CFR 1.704(c)(8). However, if the compliant appeal brief is filed more than three months from the date on which the notice of appeal was filed, the provisions of 37 CFR 1.704(c)(11) may result in reduction of any patent term adjustment under 37 CFR 1.703. 37 CFR 1.704(c)(11) provides that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date three months from the date on which the notice of appeal to the Patent Trial and Appeal Board was filed and ending on the date an appeal brief in compliance with 37 CFR 41.37 or a request for continued examination in compliance with 37 CFR 1.114 was filed.

For any application having a notice of allowance mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) is also amended to exclude ‘‘an amendment under § 1.312 or other paper expressly requested by the Office’’ from the amendments under 37 CFR 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). Thus, an amendment under 37 CFR 1.312 or other paper not expressly requested by the Office (i.e., a ‘‘voluntary’’ amendment under 37 CFR 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). An amendment under 37 CFR 1.312 or other paper going beyond what was requested by the Office (i.e., including material not expressly requested by the Office in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under 37 CFR 1.704(c)(10). In addition, the phrase ‘‘expressly requested by the Office’’ requires a specific request in an Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B), for the amendment under 37 CFR 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). Similarly, the provisions of 37 CFR 1.56, 1.97 and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). An information disclosure statement in compliance with 37 CFR 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under 37 CFR 1.704(c)(10) (or 37 CFR 1.704(c)(6), (8), or (9)) if the information disclosure statement is accompanied by a statement under 37 CFR 1.704(d). Finally, an amendment under 37 CFR 1.312 or other paper expressly requested by the Office not filed within three months from the date of mailing of the Office communication notifying the applicant of such request will result in a reduction of patent term adjustment under 37 CFR 1.704(b).

Nevertheless, the Office considers it appropriate to permit applicants to submit information cited in a patent office communication in a counterpart application to the Office without a reduction in patent term adjustment if an information disclosure statement is submitted to the Office within thirty days (not three months) of the date the patent office communication was received by an individual designated in 37 CFR 1.56(c). Accordingly, 37 CFR 1.704(d) was revised to provide that a request for continued examination in compliance with 37 CFR 1.114 with no submission other than an information disclosure statement in compliance with 37 CFR 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under 37 CFR 1.704(c)(12), if the request for continued examination is accompanied by a statement in compliance with 37 CFR 1.704(d).

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, if such a request for continued examination is filed after payment of the issue fee, any patent term adjustment would be reduced by the number of days in the period starting on the day after the date of mailing of the notice of allowance and ending on the date the request for continued examination was filed. 35 U.S.C. 154(b)(1)(A)(iv) provides that, subject to the limitations under 35 U.S.C. 154(b)(2), if the issue of an original patent is delayed due to the failure of the Office to issue a patent within four months after the date on which the issue fee was paid under 35 U.S.C. 151 and all outstanding requirements were satisfied, the term of the patent shall be extended one day for each day after the date on which the issue fee was paid and all outstanding requirements were satisfied until the patent is issued. Thus, the period of adjustment under 35 U.S.C. 154(b)(1)(A)(iv), if any, is ascertained by looking back from the issue date to the most recent time at which the issue fee or another requirement was outstanding, determining the succeeding date on which the issue fee was paid and all outstanding requirements were satisfied, and measuring the number of days, if any, in the period beginning on the day after the date that is four months after such date the issue fee was paid and all outstanding requirements were satisfied and ending on the date a patent was issued. Where prosecution in an application is reopened after a notice of allowance (before or after payment of the issue fee), either by the Office sua sponte or as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). See MPEP § 2731. The mailing of a notice of allowance by the Office subsequent to the reopening of prosecution is the Office’s indication that the application is (again) in condition to be issued as a patent, and the applicant’s return of the Issue Fee Transmittal Form (PTOL-85(b)) is the applicant’s indication or confirmation that the applicant wants any previously paid issue fee to be applied as the issue fee for the patent. See MPEP § 1306. Thus, if prosecution in an application is reopened after a notice of allowance as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). Applicants should note that 37 CFR 1.114 does not permit an applicant to file a request for continued examination under 35 U.S.C. 132(b) after the date the issue fee is paid as a matter of right. See 37 CFR 1.114(a)(1).

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, if such a request for continued examination is filed after payment of the issue fee, any patent term adjustment would be reduced by the number of days in the period starting on the day after the date of mailing of the notice of allowance and ending on the date the request for continued examination was filed. 35 U.S.C. 154(b)(1)(A)(iv) provides that, subject to the limitations under 35 U.S.C. 154(b)(2), if the issue of an original patent is delayed due to the failure of the Office to issue a patent within four months after the date on which the issue fee was paid under 35 U.S.C. 151 and all outstanding requirements were satisfied, the term of the patent shall be extended one day for each day after the date on which the issue fee was paid and all outstanding requirements were satisfied until the patent is issued. Thus, the period of adjustment under 35 U.S.C. 154(b)(1)(A)(iv), if any, is ascertained by looking back from the issue date to the most recent time at which the issue fee or another requirement was outstanding, determining the succeeding date on which the issue fee was paid and all outstanding requirements were satisfied, and measuring the number of days, if any, in the period beginning on the day after the date that is four months after such date the issue fee was paid and all outstanding requirements were satisfied and ending on the date a patent was issued. Where prosecution in an application is reopened after a notice of allowance (before or after payment of the issue fee), either by the Office sua sponte or as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). See MPEP § 2731. The mailing of a notice of allowance by the Office subsequent to the reopening of prosecution is the Office’s indication that the application is (again) in condition to be issued as a patent, and the applicant’s return of the Issue Fee Transmittal Form (PTOL-85(b)) is the applicant’s indication or confirmation that the applicant wants any previously paid issue fee to be applied as the issue fee for the patent. See MPEP § 1306. Thus, if prosecution in an application is reopened after a notice of allowance as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). Applicants should note that 37 CFR 1.114 does not permit an applicant to file a request for continued examination under 35 U.S.C. 132(b) after the date the issue fee is paid as a matter of right. See 37 CFR 1.114(a)(1).

(c) Circumstances that constitute a failure of the applicant to engage in reasonable efforts to conclude processing or examination of an application also include the following circumstances, which will result in the following reduction of the period of adjustment set forth in § 1.703 to the extent that the periods are not overlapping:
…
(14) Further prosecution via a continuing application, in which case the period of adjustment set forth in § 1.703 shall not include any period that is prior to the actual filing date of the application that resulted in the patent.

(f) An application filed under 35 U.S.C. 111(a) is in condition for examination when it includes a specification, including at least one claim and an abstract (§ 1.72(b)), and has papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, any English translation required by § 1.52(d) or § 1.57(a), a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), an inventor’s oath or declaration or an application data sheet containing the information specified in § 1.63(b), the basic filing fee (§ 1.16(a) or (c)), the search fee (§ 1.16(k) or (m)), the examination fee (§ 1.16(o) or (q)), any certified copy of the previously filed application required by § 1.57(a), and any application size fee required by the Office under § 1.16(s). An international application is in condition for examination when it has entered the national stage as defined in § 1.491(b), and includes a specification, including at least one claim and an abstract (§ 1.72(b)), and has papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), an inventor’s oath or declaration or an application data sheet containing the information specified in § 1.63(b), the search fee (§ 1.492(b)), the examination fee (§ 1.492(c)), and any application size fee required by the Office under § 1.492(j). An application shall be considered as having papers in compliance with § 1.52, drawings (if any) in compliance with § 1.84, and a “Sequence Listing” in compliance with §§ 1.821 through 1.825 (if applicable), or a “Sequence Listing XML” in compliance with §§ 1.831 through 1.835 (if applicable), for purposes of this paragraph (f) on the filing date of the latest reply (if any) correcting the papers, drawings, “Sequence Listing,” or “Sequence Listing XML” that is prior to the date of mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151, whichever occurs first.

37 CFR 1.704(b) provides that with respect to the ground for adjustments set forth in 37 CFR 1.702(a) through (e), and in particular 37 CFR 1.702(b), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude prosecution for the cumulative total of any periods of time in excess of three months that are taken to reply to any notice or action by the Office making any rejection, objection, argument, or other request, measuring such three-month period from the date the notice or action was mailed or given to the applicant. A Notice of Omitted Items in a Nonprovisional Application, however, is not a notice or action by the Office making a rejection, objection, argument, or other request within the meaning of 35 U.S.C. 154(b)(2)(C)(ii) or 37 CFR 1.704(b), since the Office does not require a reply to that notice to continue the processing and examination of an application. 37 CFR 1.704(b) indicates that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date that is three months after the date of mailing or transmission of the Office communication notifying the applicant of the rejection, objection, argument, or other request and ending on the date the reply was filed. As discussed above, a reply is considered filed on the date of its actual receipt in the Office as defined by 37 CFR 1.6, and the date indicated on any certificate of mailing or transmission under 37 CFR 1.8 will not be taken into account for patent term adjustment purposes.

The three-month period in 37 CFR 1.704(b) applies to the Office notices and letters issued as part of the pre-examination processing of an application (except a Notice of Omitted Items in a Nonprovisional Application as discussed above). These notices include: (1) a Notice of Incomplete Nonprovisional Application (except as to any period prior to the filing date ultimately accorded to the application); (2) a Notice to File Missing Parts of Non-Provisional Application; (3) an Informational Notice to Applicant; (4) a Notice to File Corrected Application Papers Filing Date Granted; or (5) a Notice to Comply with Requirements for Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures.

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

A reply under 37 CFR 1.116 to an Office action containing a final rejection must cancel or appeal each rejected claim and comply with all patentability requirements and objections as to form for each allowed claim. See 37 CFR 1.113(c). “ Section 1.703(a) is in fact entirely consistent with our and the Patent Office's reading of ‘reply’ in § 1.704(b). The specific reference to a ‘reply in compliance with § 1.113(c) ’ in § 1.703(a) reflects the Patent Office's recognition that Office actions in response to replies to final Office actions and Office actions in response to replies to non-final Office actions represent two different situations, both of which may separately give rise to agency delay.” Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1384, 2019 USPQ2d 350004 (Fed. Cir. 2019). Accordingly, an applicant can only stop the three-month clock under 37 CFR 1.704(b) by filing a compliant reply under 37 CFR 1.113(c), appealing the final rejection, or filing a request for continued examination. For example, the Office mailed a final rejection on October 10, 2017. On January 8, 2018, applicant filed a reply under 37 CFR 1.116 that would result in the allowance of only some of the pending claims. In other words, the remaining claims would still be in the rejected status even if the January 8, 2018 amendment was entered into the record. On January 17, 2018, the Office mailed an advisory action that informed applicant that the January 8, 2018 amendment failed to overcome all of the rejections of record. On February 5, 2018, applicant filed a Notice of Appeal. In this case, applicant would have a PTA reduction under 37 CFR 1.704(b) for the period beginning on January 11, 2018 (the day after three months from the mailing date of the final rejection) and ending on February 5, 2018 (the day the notice of appeal was filed).

37 CFR 1.704(c)(1) through 1.704(c)(14) address situations that occur with sufficient frequency to warrant being specifically provided for in the rules of practice. These situations do not represent an exhaustive list of actions or inactions that interfere with the Office’s ability to process or examine an application, since there are a myriad of actions or inactions that occur infrequently but will interfere with the Office’s ability to process or examine an application (e.g., applicant files and persists in requesting reconsideration of a meritless petition under 37 CFR 1.10; parties to an interference obtain an extension for purposes of settlement negotiations which do not result in settlement of the interference; and when the scope of the broadest claim in the application at the time an application is placed in condition for allowance is substantially the same as suggested or allowed by the examiner more than six months earlier than the date the application was placed in condition for allowance). Thus, the actions or inactions set forth in 37 CFR 1.704(c) are exemplary circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The Office may also reduce a period of adjustment provided in 37 CFR 1.703 on the basis of conduct that interferes with the Office’s ability to process or examine an application under the authority provided in 35 U.S.C. 154(b)(2)(C)(iii), even if such conduct is not specifically addressed in 37 CFR 1.704(c).

37 CFR 1.704(c)(7) establishes submission of a reply having an omission (e.g., 37 CFR 1.135(c)) as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Submitting a reply having an omission requires the Office to issue an action under 37 CFR 1.135(c) and await and process the applicant’s reply to the action under 37 CFR 1.135(c) before the initial reply (as corrected) can be treated on its merits. In addition, 37 CFR 1.704(c)(7) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date the reply having an omission was filed and ending on the date that the reply or other paper correcting the omission was filed. The reference to 37 CFR 1.135(c) is parenthetical because 37 CFR 1.704(c)(7) is not limited to Office actions under 37 CFR 1.135(c) but applies also when the Office issues any action or notice indicating that a reply has an omission which must be corrected: for example, (1) a decision on a petition under 37 CFR 1.47 dismissing the petition as lacking an item necessary to grant the petition; or (2) a notice indicating that the computer readable sequence listing submitted in an application filed on or after July 1, 2022, in reply to a previous notice relating to the requirements for patent applications containing nucleotide and/or amino acid sequence disclosures, does not comply with 37 CFR 1.831 et seq. The filing of a non-compliant appeal brief, however, will not be deemed an omission under 37 CFR 1.704(c)(7) if the notice of appeal was filed on or after September 17, 2012. This situation is covered under 37 CFR 1.704(c)(11).

37 CFR 1.704(c)(9) establishes submission of an amendment or other paper (other than a statement under 37 CFR 41.50(c)) in an application after a decision by the Patent Trial and Appeal Board (other than a decision containing a rejection under 37 CFR 41.50(b)) or a federal court less than one month before the mailing of an Office action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151, that requires the mailing of a supplemental Office action or supplemental notice of allowance as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. The submission of an amendment or other paper (e.g., IDS or petition) in an application after a Board decision or court decision requires the Office to restart consideration of the application in view of the amendment or other paper, which will result in a delay in the Office’s taking action on the application. For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(9) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of the decision by the Patent Trial and Appeal Board or by a federal court and ending on the date the amendment or other paper was filed. For all other applications, the period of adjustment shall be reduced by the lesser of the number of days, if any, beginning on the day after the mailing date of the original Office action or notice of allowance and ending on the mailing date of the supplemental Office action or notice of allowance or four months. The phrase “lesser of…or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(9) if the Office takes longer than four months to issue a supplemental Office action or notice of allowance. If the amendment is requested by an examiner, the examiner will have the paper processed so that it is included as part of an interview summary or examiner’s amendment and not a separate paper for OPSG to flag in the patent term adjustment calculation.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

37 CFR 1.704(c)(10) establishes submission of an amendment under 37 CFR 1.312 or other paper, other than a request for continued examination in compliance with 37 CFR 1.114, after a notice of allowance has been given or mailed as a circumstance that constitutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application. Effective March 10, 2015, 37 CFR 1.704(c)(10) was amended to change “other paper” to “other paper, other than a request for continued examination in compliance with § 1.114,” to clarify that the filing of a request for continued examination under 35 U.S.C. 132(b) in compliance with 37 CFR 1.114 is treated under 37 CFR 1.704(c)(12) rather than 37 CFR 1.704(c)(10). See the final rule Changes to Patent Term Adjustment in view of the Federal Circuit Decision in Novartis v. Lee, 80 FR 1346 (January 9, 2015). Prior to March 10, 2015, the submission of a request for continued examination after the mailing date of a notice of allowance was not considered an applicant delay under 37 CFR 1.704. The submission of amendments (or other papers) after an application is allowed may cause substantial interference with the patent issue process. Certain papers filed after allowance are not considered to be a failure to engage in reasonable efforts to conclude processing or examination of an application. See Clarification of 37 CFR 1.704(c)(10) – Reduction of Patent Term Adjustment for Certain Types of Papers Filed After a Notice of Allowance has been Mailed, 1247 OG 111 (June 26, 2001). For applications in which a notice of allowance was mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) provides that in such a case the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under 37 CFR 1.312 or other paper was filed, except for an amendment under 37 CFR 1.312 or other paper that was expressly requested by the Office as further discussed below. For all other applications, the period of adjustment shall be reduced by the lesser of: (1) the number of days, if any, beginning on the date the amendment under 37 CFR 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under 37 CFR 1.312 or such other paper; or (2) four months. The phrase “lesser of …or [f]our months” is to provide a four-month cap for a reduction under 37 CFR 1.704(c)(10) if the Office takes longer than four months to issue an Office action or notice in response to the amendment under 37 CFR 1.312 or other paper. If the Office does not mail a response to the paper that triggered the delay under this provision and the patent issues in less than four months, then the applicant delay under this provision will end on the date of the patent issuance. The Office will treat the issuance of the patent as the response to the paper that triggered the delay.

For any application having a notice of allowance mailed on or after July 16, 2020, 37 CFR 1.704(c)(10) is also amended to exclude ‘‘an amendment under § 1.312 or other paper expressly requested by the Office’’ from the amendments under 37 CFR 1.312 or other papers filed after a notice of allowance that will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). Thus, an amendment under 37 CFR 1.312 or other paper not expressly requested by the Office (i.e., a ‘‘voluntary’’ amendment under 37 CFR 1.312 or other paper) after the notice of allowance will result in a reduction of patent term adjustment under 37 CFR 1.704(c)(10). An amendment under 37 CFR 1.312 or other paper going beyond what was requested by the Office (i.e., including material not expressly requested by the Office in addition to what was requested by the USPTO) would not be considered “an amendment under § 1.312 or other paper expressly requested by the Office” under 37 CFR 1.704(c)(10). In addition, the phrase ‘‘expressly requested by the Office’’ requires a specific request in an Office action or notice, or in an Examiner’s Interview Summary (form PTOL– 413/413B), for the amendment under 37 CFR 1.312 or other paper. For example, generic language in an Office action or notice, such as a statement in a notice of allowability containing an examiner’s amendment indicating that if the changes and/or additions are unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312 (see MPEP § 1302.04), is not a basis for considering an amendment under 37 CFR 1.312 to be ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). Similarly, the provisions of 37 CFR 1.56, 1.97 and 1.98 are not a basis for considering an information disclosure statement including information that has come to the attention of the applicant after a notice of allowance has been given or mailed to be a paper ‘‘expressly requested by the Office’’ within the meaning of 37 CFR 1.704(c)(10). An information disclosure statement in compliance with 37 CFR 1.97 and 1.98, however, will not be considered a failure to engage in reasonable efforts to conclude prosecution of the application under 37 CFR 1.704(c)(10) (or 37 CFR 1.704(c)(6), (8), or (9)) if the information disclosure statement is accompanied by a statement under 37 CFR 1.704(d). Finally, an amendment under 37 CFR 1.312 or other paper expressly requested by the Office not filed within three months from the date of mailing of the Office communication notifying the applicant of such request will result in a reduction of patent term adjustment under 37 CFR 1.704(b).

The submission of the following papers after a “Notice of Allowance” is not considered a failure to engage in reasonable efforts to conclude processing or examination of an application: (1) Fee(s) Transmittal (PTOL-85B); (2) power of attorney; (3) power to inspect; (4) change of address; (5) change of status (micro/small/not small entity status); (6) a response to the examiner’s reasons for allowance or a request to correct an error or omission in the “Notice of Allowance” or “Notice of Allowability;” (7) status letters; (8) requests for a refund; (9) an inventor’s oath or declaration; (10) an information disclosure statement with a statement in compliance with 37 CFR 1.704(d); (11) the resubmission by applicant of unlocatable paper(s) previously filed in the application (37 CFR 1.251); (12) a request for acknowledgment of an information disclosure statement in compliance with 37 CFR 1.97 and 1.98, provided that the applicant had requested that the examiner acknowledge the information disclosure statement prior to the notice of allowance, or the request for acknowledgement was applicant’s first opportunity to request that the examiner acknowledge the information disclosure statement; (13) comments on the substance of an interview where the applicant-initiated interview resulted in a notice of allowance; and (14) letters related to government interests (e.g., those between NASA and the Office).

Effective for applications in which a notice of appeal was filed on or after September 17, 2012, 37 CFR 1.704(c)(11) establishes that failure to file an appeal brief in compliance with 37 CFR 41.37 within three months from the date on which a notice of appeal to the Patent Trial and Appeal Board was filed under 35 U.S.C. 134 and 37 CFR 41.31 is a circumstance that constitutes a failure to engage in reasonable efforts to conclude processing or examination of the application. It is noted that although the appeal brief is due within two months of the filing of the notice of appeal under 37 CFR 41.37, 37 CFR 1.704(c)(11) provides three months before any patent term adjustment under 37 CFR 1.703 will be reduced for the late submission of an appeal brief. If applicant files a non-compliant appeal brief and thereafter files a compliant appeal brief, the period of time from the filing of a non-compliant appeal brief to the filing of the compliant appeal brief will not be considered a failure to engage in reasonable efforts to conclude processing or examination of the application under 37 CFR 1.704(c)(8). However, if the compliant appeal brief is filed more than three months from the date on which the notice of appeal was filed, the provisions of 37 CFR 1.704(c)(11) may result in reduction of any patent term adjustment under 37 CFR 1.703. 37 CFR 1.704(c)(11) provides that the period of adjustment set forth in 37 CFR 1.703 shall be reduced by the number of days, if any, beginning on the day after the date three months from the date on which the notice of appeal to the Patent Trial and Appeal Board was filed and ending on the date an appeal brief in compliance with 37 CFR 41.37 or a request for continued examination in compliance with 37 CFR 1.114 was filed.

Effective for applications in which a request for continued examination was filed on or after March 10, 2015, if such a request for continued examination is filed after payment of the issue fee, any patent term adjustment would be reduced by the number of days in the period starting on the day after the date of mailing of the notice of allowance and ending on the date the request for continued examination was filed. 35 U.S.C. 154(b)(1)(A)(iv) provides that, subject to the limitations under 35 U.S.C. 154(b)(2), if the issue of an original patent is delayed due to the failure of the Office to issue a patent within four months after the date on which the issue fee was paid under 35 U.S.C. 151 and all outstanding requirements were satisfied, the term of the patent shall be extended one day for each day after the date on which the issue fee was paid and all outstanding requirements were satisfied until the patent is issued. Thus, the period of adjustment under 35 U.S.C. 154(b)(1)(A)(iv), if any, is ascertained by looking back from the issue date to the most recent time at which the issue fee or another requirement was outstanding, determining the succeeding date on which the issue fee was paid and all outstanding requirements were satisfied, and measuring the number of days, if any, in the period beginning on the day after the date that is four months after such date the issue fee was paid and all outstanding requirements were satisfied and ending on the date a patent was issued. Where prosecution in an application is reopened after a notice of allowance (before or after payment of the issue fee), either by the Office sua sponte or as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). See MPEP § 2731. The mailing of a notice of allowance by the Office subsequent to the reopening of prosecution is the Office’s indication that the application is (again) in condition to be issued as a patent, and the applicant’s return of the Issue Fee Transmittal Form (PTOL-85(b)) is the applicant’s indication or confirmation that the applicant wants any previously paid issue fee to be applied as the issue fee for the patent. See MPEP § 1306. Thus, if prosecution in an application is reopened after a notice of allowance as the result of an applicant filing a request for continued examination, the date on which the issue fee was paid and all outstanding requirements were satisfied is the date on which the Issue Fee Transmittal Form (PTOL-85(b)) from the ultimate notice of allowance under 35 U.S.C. 151 is returned to the Office (or a later date if there remain additional outstanding requirements, such as payment of any additional fees owed or required drawings to be submitted). Applicants should note that 37 CFR 1.114 does not permit an applicant to file a request for continued examination under 35 U.S.C. 132(b) after the date the issue fee is paid as a matter of right. See 37 CFR 1.114(a)(1).