The language of 37 CFR 1.56 (and 37 CFR 1.555) emphasizes that there is a duty of candor and good faith which is broader than the duty to disclose material information. 37 CFR 1.56 further states that “no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.” Specifically, the duty of candor and good faith, and by extension the duty to disclose, applies to positions taken by applicants or parties involving the claimed subject matter.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

37 CFR 1.56 states that each individual associated with the filing and prosecution of a patent application has a duty to disclose all information known to that individual to be material to patentability as defined in the section. Thus, the duty applies to contemporaneously or presently known information. The fact that information was known years ago does not mean that it was recognized that the information is material to the present application.

The term “information” as used in 37 CFR 1.56 means all of the kinds of information required to be disclosed and includes any information which is “material to patentability.” Materiality is defined in 37 CFR 1.56(b) and discussed herein at MPEP § 2001.05. In addition to prior art such as patents and publications, 37 CFR 1.56 includes, for example, information on enablement, possible prior public uses, sales, offers to sell, derived knowledge, prior invention by another, inventorship conflicts, litigation statements, and the like. “Materiality is not limited to prior art but embraces any information that a reasonable examiner would be substantially likely to consider important in deciding whether to allow an application to issue as a patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003) (emphasis in original) (finding article which was not prior art to be material to enablement issue).

The term “information” as used in 37 CFR 1.56 means all of the kinds of information required to be disclosed and includes any information which is “material to patentability.” Materiality is defined in 37 CFR 1.56(b) and discussed herein at MPEP § 2001.05. In addition to prior art such as patents and publications, 37 CFR 1.56 includes, for example, information on enablement, possible prior public uses, sales, offers to sell, derived knowledge, prior invention by another, inventorship conflicts, litigation statements, and the like. “Materiality is not limited to prior art but embraces any information that a reasonable examiner would be substantially likely to consider important in deciding whether to allow an application to issue as a patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003) (emphasis in original) (finding article which was not prior art to be material to enablement issue).

The term “information” as used in 37 CFR 1.56 means all of the kinds of information required to be disclosed and includes any information which is “material to patentability.” Materiality is defined in 37 CFR 1.56(b) and discussed herein at MPEP § 2001.05. In addition to prior art such as patents and publications, 37 CFR 1.56 includes, for example, information on enablement, possible prior public uses, sales, offers to sell, derived knowledge, prior invention by another, inventorship conflicts, litigation statements, and the like. “Materiality is not limited to prior art but embraces any information that a reasonable examiner would be substantially likely to consider important in deciding whether to allow an application to issue as a patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003) (emphasis in original) (finding article which was not prior art to be material to enablement issue).

37 CFR 1.56(a) states that the duty to disclose information exists until the application becomes abandoned. The duty to disclose information, however, does not end when an application becomes allowed but extends until a patent is granted on that application. The rules provide for information being considered after a notice of allowance is mailed and before the issue fee is paid (37 CFR 1.97(d)) (see MPEP § 609.04(b), subsection III). The rules also provide for an application to be withdrawn from issue:
…
(C) for consideration of a request for continued examination (RCE) under 37 CFR 1.114 (37 CFR 1.313(a) and (c)(2)).

37 CFR 1.56(a) states that the duty to disclose information exists until the application becomes abandoned. The duty to disclose information, however, does not end when an application becomes allowed but extends until a patent is granted on that application. The rules provide for information being considered after a notice of allowance is mailed and before the issue fee is paid (37 CFR 1.97(d)) (see MPEP § 609.04(b), subsection III). The rules also provide for an application to be withdrawn from issue:
…
Note that RCE practice does not apply to utility or plant applications filed before June 8, 1995 or to design applications. See MPEP § 706.07(h).

See MPEP § 1308 for additional information pertaining to withdrawal of an application from issue.

37 CFR 1.555 provides for the duty of disclosure in reexamination proceedings. For a discussion of information material to patentability in a reexamination proceeding, see MPEP § 2280 or MPEP § 2684. For supplemental examination and any ex parte reexamination proceeding ordered under 35 U.S.C. 257, information material to patentability is defined by 37 CFR 1.56. See 37 CFR 1.625(d)(4) and MPEP § 2820.

37 CFR 1.555 provides for the duty of disclosure in reexamination proceedings. For a discussion of information material to patentability in a reexamination proceeding, see MPEP § 2280 or MPEP § 2684. For supplemental examination and any ex parte reexamination proceeding ordered under 35 U.S.C. 257, information material to patentability is defined by 37 CFR 1.56. See 37 CFR 1.625(d)(4) and MPEP § 2820.

(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b) – (d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:
…
(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

The Office strives to issue valid patents. The Office has both an obligation not to unjustly issue patents and an obligation not to unjustly deny patents. Innovation and technological advancement are best served when an inventor is issued a patent with the scope of protection that is deserved. The rules serve to remind individuals associated with the preparation and prosecution of patent applications of their duty of candor and good faith in their dealings with the Office, and will aid the Office in receiving, in a timely manner, the information it needs to carry out effective and efficient examination of patent applications. Moreover, an incentive exists to submit material information to the Office because it may result in enhanced patent quality and may avoid later questions of materiality and intent to deceive.

The term “information” is intended to be all encompassing, similar to the scope of the term as discussed with respect to 37 CFR 1.291(a) (see MPEP § 1901.02). 37 CFR 1.56(a) also states: “The Office encourages applicants to carefully examine: (1) prior art cited in search reports of a foreign patent office in a counterpart application, and (2) the closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.”

(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b) – (d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:

• (1) Prior art cited in search reports of a foreign patent office in a counterpart application, and
• (2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.

The Office strives to issue valid patents. The Office has both an obligation not to unjustly issue patents and an obligation not to unjustly deny patents. Innovation and technological advancement are best served when an inventor is issued a patent with the scope of protection that is deserved. The rules serve to remind individuals associated with the preparation and prosecution of patent applications of their duty of candor and good faith in their dealings with the Office, and will aid the Office in receiving, in a timely manner, the information it needs to carry out effective and efficient examination of patent applications. Moreover, an incentive exists to submit material information to the Office because it may result in enhanced patent quality and may avoid later questions of materiality and intent to deceive.

37 CFR 1.56 states that each individual associated with the filing and prosecution of a patent application has a duty to disclose all information known to that individual to be material to patentability as defined in the section. Thus, the duty applies to contemporaneously or presently known information. The fact that information was known years ago does not mean that it was recognized that the information is material to the present application.

The Office strives to issue valid patents. The Office has both an obligation not to unjustly issue patents and an obligation not to unjustly deny patents. Innovation and technological advancement are best served when an inventor is issued a patent with the scope of protection that is deserved. The rules serve to remind individuals associated with the preparation and prosecution of patent applications of their duty of candor and good faith in their dealings with the Office, and will aid the Office in receiving, in a timely manner, the information it needs to carry out effective and efficient examination of patent applications. Moreover, an incentive exists to submit material information to the Office because it may result in enhanced patent quality and may avoid later questions of materiality and intent to deceive.

The Office strives to issue valid patents. The Office has both an obligation not to unjustly issue patents and an obligation not to unjustly deny patents. Innovation and technological advancement are best served when an inventor is issued a patent with the scope of protection that is deserved. The rules serve to remind individuals associated with the preparation and prosecution of patent applications of their duty of candor and good faith in their dealings with the Office, and will aid the Office in receiving, in a timely manner, the information it needs to carry out effective and efficient examination of patent applications. Moreover, an incentive exists to submit material information to the Office because it may result in enhanced patent quality and may avoid later questions of materiality and intent to deceive.

The term “information” as used in 37 CFR 1.56 means all of the kinds of information required to be disclosed and includes any information which is “material to patentability.” Materiality is defined in 37 CFR 1.56(b) and discussed herein at MPEP § 2001.05. In addition to prior art such as patents and publications, 37 CFR 1.56 includes, for example, information on enablement, possible prior public uses, sales, offers to sell, derived knowledge, prior invention by another, inventorship conflicts, litigation statements, and the like. “Materiality is not limited to prior art but embraces any information that a reasonable examiner would be substantially likely to consider important in deciding whether to allow an application to issue as a patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003) (emphasis in original) (finding article which was not prior art to be material to enablement issue).

37 CFR 1.56(a) states that the duty to disclose information exists until the application becomes abandoned. The duty to disclose information, however, does not end when an application becomes allowed but extends until a patent is granted on that application. The rules provide for information being considered after a notice of allowance is mailed and before the issue fee is paid (37 CFR 1.97(d)) (see MPEP § 609.04(b), subsection III). The rules also provide for an application to be withdrawn from issue:

• (A) because one or more claims are unpatentable (37 CFR 1.313(c)(1));
• (B) for express abandonment so that information may be considered in a continuing application before a patent issues (37 CFR 1.313(c)(3)); or
• (C) for consideration of a request for continued examination (RCE) under 37 CFR 1.114 (37 CFR 1.313(a) and (c)(2)). Note that RCE practice does not apply to utility or plant applications filed before June 8, 1995 or to design applications. See MPEP § 706.07(h).

37 CFR 1.56 provides that the duty of disclosure can be met by submitting information to the Office in the manner prescribed by 37 CFR 1.97 and 1.98. See MPEP § 609 et seq. Applicants are provided certainty as to when information will be considered, and applicants will be informed when information is not considered. Note, however, if even a document was cited to or considered in a prior examination or related Office proceeding, the Office may order reexamination based on the document if it raises a substantial new question of patentability. See MPEP § 2242 and MPEP § 2258.01.

37 CFR 1.56 provides that the duty of disclosure can be met by submitting information to the Office in the manner prescribed by 37 CFR 1.97 and 1.98. See MPEP § 609 et seq. Applicants are provided certainty as to when information will be considered, and applicants will be informed when information is not considered. Note, however, if even a document was cited to or considered in a prior examination or related Office proceeding, the Office may order reexamination based on the document if it raises a substantial new question of patentability. See MPEP § 2242 and MPEP § 2258.01.

The language of 37 CFR 1.56 (and 37 CFR 1.555) emphasizes that there is a duty of candor and good faith which is broader than the duty to disclose material information. 37 CFR 1.56 further states that “no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.” Specifically, the duty of candor and good faith, and by extension the duty to disclose, applies to positions taken by applicants or parties involving the claimed subject matter.

37 CFR 1.555 provides for the duty of disclosure in reexamination proceedings. For a discussion of information material to patentability in a reexamination proceeding, see MPEP § 2280 or MPEP § 2684. For supplemental examination and any ex parte reexamination proceeding ordered under 35 U.S.C. 257, information material to patentability is defined by 37 CFR 1.56. See 37 CFR 1.625(d)(4) and MPEP § 2820.

The language of 37 CFR 1.56 (and 37 CFR 1.555) emphasizes that there is a duty of candor and good faith which is broader than the duty to disclose material information. 37 CFR 1.56 further states that “no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct.” Specifically, the duty of candor and good faith, and by extension the duty to disclose, applies to positions taken by applicants or parties involving the claimed subject matter.

Patent examiners also have the ability to require submission of information that may be reasonably necessary to properly examine or treat a matter in a pending or abandoned application, but not necessarily “material to patentability.” 37 CFR 1.105(a)(1). The information that must be submitted to comply with a requirement for information under 37 CFR 1.105 may not be material to patentability in itself under 37 CFR 1.56, but it is necessary to obtain a complete record from which a determination of patentability may be made. See MPEP § 704.12(a). Therefore, when an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other Government agencies such as the FDA. See MPEP § 2015. For example, when examining a claim directed to a process of manufacturing a particular drug product that was effectively filed more than one year after FDA approval of the drug product, an examiner may appropriately require an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New Drug Application or Biologics License Application) on how the drug product was manufactured.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

The definition of materiality in 37 CFR 1.56 is intended to provide the Office with the information it needs in order for the examiner to make a proper and independent determination on patentability. The patent examiner should make the patentability determination after considering the relevant facts properly of record in the particular case.

The definition of materiality in 37 CFR 1.56 is intended to provide the Office with the information it needs in order for the examiner to make a proper and independent determination on patentability. The patent examiner should make the patentability determination after considering the relevant facts properly of record in the particular case.

The term “information” as used in 37 CFR 1.56 means all of the kinds of information required to be disclosed and includes any information which is “material to patentability.” Materiality is defined in 37 CFR 1.56(b) and discussed herein at MPEP § 2001.05. In addition to prior art such as patents and publications, 37 CFR 1.56 includes, for example, information on enablement, possible prior public uses, sales, offers to sell, derived knowledge, prior invention by another, inventorship conflicts, litigation statements, and the like. “Materiality is not limited to prior art but embraces any information that a reasonable examiner would be substantially likely to consider important in deciding whether to allow an application to issue as a patent.” Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003) (emphasis in original) (finding article which was not prior art to be material to enablement issue).

In a continuation-in-part application, individuals covered by 37 CFR 1.56 have a duty to disclose to the Office all information known to be material to patentability which became available between the filing date of the prior application and the national or PCT international filing date of the continuation-in-part application. See 37 CFR 1.56(e).

Patent examiners also have the ability to require submission of information that may be reasonably necessary to properly examine or treat a matter in a pending or abandoned application, but not necessarily “material to patentability.” 37 CFR 1.105(a)(1). The information that must be submitted to comply with a requirement for information under 37 CFR 1.105 may not be material to patentability in itself under 37 CFR 1.56, but it is necessary to obtain a complete record from which a determination of patentability may be made. See MPEP § 704.12(a). Therefore, when an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other Government agencies such as the FDA. See MPEP § 2015. For example, when examining a claim directed to a process of manufacturing a particular drug product that was effectively filed more than one year after FDA approval of the drug product, an examiner may appropriately require an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New Drug Application or Biologics License Application) on how the drug product was manufactured.

Patent examiners also have the ability to require submission of information that may be reasonably necessary to properly examine or treat a matter in a pending or abandoned application, but not necessarily “material to patentability.” 37 CFR 1.105(a)(1). The information that must be submitted to comply with a requirement for information under 37 CFR 1.105 may not be material to patentability in itself under 37 CFR 1.56, but it is necessary to obtain a complete record from which a determination of patentability may be made. See MPEP § 704.12(a). Therefore, when an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other Government agencies such as the FDA. See MPEP § 2015. For example, when examining a claim directed to a process of manufacturing a particular drug product that was effectively filed more than one year after FDA approval of the drug product, an examiner may appropriately require an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New Drug Application or Biologics License Application) on how the drug product was manufactured.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

If a party to a USPTO proceeding discovers that an earlier position taken in a submission to the USPTO or another Government agency was incorrect or inconsistent with other statements made by the party, the party must promptly correct the record. See, e.g., In re Tendler, Proceeding No. D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to correct the written record after learning of inaccuracies in a declaration the practitioner had filed). In the context of prosecution, an applicant must disclose to the USPTO any information that refutes, or is inconsistent with, a position the applicant takes in: (i) opposing an argument of unpatentability relied on by the Office, or (ii) asserting an argument of patentability. See 37 CFR 1.56(b)(2). Patent owners may bring information, including prior art and incorrect or inconsistent positions, to the attention of the USPTO through supplemental examination, ex parte reexamination, reissue applications, or submissions under 37 CFR 1.501. During prosecution, third parties may have an opportunity to disclose information to the USPTO through third party submissions under 37 CFR 1.290 and protests under 37 CFR 1.291. After issuance, third parties may disclose information directed to issued patents to the USPTO via submissions under 37 CFR 1.501, or in ex parte reexamination. A finding of “fraud,” “inequitable conduct,” or violation of duty of disclosure through bad faith or intentional misconduct with respect to any claim in an application or patent, renders all the claims thereof unpatentable or invalid. See MPEP § 2016.

Patent examiners also have the ability to require submission of information that may be reasonably necessary to properly examine or treat a matter in a pending or abandoned application, but not necessarily “material to patentability.” 37 CFR 1.105(a)(1). The information that must be submitted to comply with a requirement for information under 37 CFR 1.105 may not be material to patentability in itself under 37 CFR 1.56, but it is necessary to obtain a complete record from which a determination of patentability may be made. See MPEP § 704.12(a). Therefore, when an examiner has a reasonable basis to conclude that an individual identified under 37 CFR 1.56(c) or any assignee has information that would aid in the examination of the application or treatment of some matter, the examiner may require submission of information that is not necessarily material to patentability. This requirement could include statements made or information submitted to other Government agencies such as the FDA. See MPEP § 2015. For example, when examining a claim directed to a process of manufacturing a particular drug product that was effectively filed more than one year after FDA approval of the drug product, an examiner may appropriately require an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New Drug Application or Biologics License Application) on how the drug product was manufactured.

The term “information” is intended to be all encompassing, similar to the scope of the term as discussed with respect to 37 CFR 1.291(a) (see MPEP § 1901.02). 37 CFR 1.56(a) also states: “The Office encourages applicants to carefully examine: (1) prior art cited in search reports of a foreign patent office in a counterpart application, and (2) the closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.”

It should be noted that the rules are not intended to require information favorable to patentability such as, for example, evidence of commercial success of the invention. Similarly, the rules are not intended to require, for example, disclosure of information concerning the level of skill in the art for purposes of determining obviousness.

It should be noted that the rules are not intended to require information favorable to patentability such as, for example, evidence of commercial success of the invention. Similarly, the rules are not intended to require, for example, disclosure of information concerning the level of skill in the art for purposes of determining obviousness.

37 CFR 1.56 provides that the duty of disclosure can be met by submitting information to the Office in the manner prescribed by 37 CFR 1.97 and 1.98. See MPEP § 609 et seq. Applicants are provided certainty as to when information will be considered, and applicants will be informed when information is not considered. Note, however, if even a document was cited to or considered in a prior examination or related Office proceeding, the Office may order reexamination based on the document if it raises a substantial new question of patentability. See MPEP § 2242 and MPEP § 2258.01.