In view of lengthy data listings being submitted as part of the disclosure in some patent applications, the Office has established procedures for the presentation of “Large Tables (37 CFR 1.58), a "Computer Program Listing Appendix" (37 CFR 1.96(c)), a "Sequence Listing" and a Computer Readable Form (CRF) of a “Sequence Listing” (37 CFR1.821(c) and (e)), and a “Sequence Listing XML” (37 CFR 1.831(a)) in electronic form. Such listings are often several hundred pages or more in length. By filing and publishing such data listings in electronic form, substantial cost savings can result to the applicants, the public, and the U.S. Patent and Trademark Office.

In view of lengthy data listings being submitted as part of the disclosure in some patent applications, the Office has established procedures for the presentation of “Large Tables (37 CFR 1.58), a "Computer Program Listing Appendix" (37 CFR 1.96(c)), a "Sequence Listing" and a Computer Readable Form (CRF) of a “Sequence Listing” (37 CFR1.821(c) and (e)), and a “Sequence Listing XML” (37 CFR 1.831(a)) in electronic form. Such listings are often several hundred pages or more in length. By filing and publishing such data listings in electronic form, substantial cost savings can result to the applicants, the public, and the U.S. Patent and Trademark Office.

A “Sequence Listing” under 37 CFR 1.821 through 1.825 may be submitted as an ASCII plain text file only in applications filed before July 1, 2022. The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing XML” under 37 CFR 1.831 through 1.839 for applications filed on or after July 1, 2022, see subsection II below.

“Large Tables” (see 37 CFR 1.58(c)), a “Computer Program Listing Appendix” (see 37 CFR 1.96(c)), a “Sequence Listing” (see 37 CFR 1.821(c)(1)), and a CRF of a “Sequence Listing” (see 37 CFR 1.821(e)(1) or (e)(2)), and “Large Tables” (see 37 CFR 1.58(c)) may be submitted as ASCII text files via the USPTO patent electronic filing system. Each plain text file must be in compliance with ASCII and have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3), which provide all requirements for the file name.
“Large Tables” (see 37 CFR 1.58(c)), a “Computer Program Listing Appendix” (see 37 CFR 1.96(c)), a “Sequence Listing” (see 37 CFR 1.821(c)(1)), and a CRF of a “Sequence Listing” (see 37 CFR 1.821(e)(1) or (e)(2)), and “Large Tables (see 37 CFR 1.58(c)) may be submitted as ASCII text files via the USPTO patent electronic filing system.

“Large Tables” (see 37 CFR 1.58(c)), a “Computer Program Listing Appendix” (see 37 CFR 1.96(c)), a “Sequence Listing” (see 37 CFR 1.821(c)(1)), and a CRF of a “Sequence Listing” (see 37 CFR 1.821(e)(1) or (e)(2)), and “Large Tables” (see 37 CFR 1.58(c)) may be submitted as ASCII text files via the USPTO patent electronic filing system. Each plain text file must be in compliance with ASCII and have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3), which provide all requirements for the file name.

In situations where an applicant is filing an amendment to a “Sequence Listing” via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(b), the Office recommends filing a replacement “Sequence Listing” as an ASCII plain text file where the applicant requests that the replacement “Sequence Listing” text file be entered using an incorporation by reference statement (37 CFR 1.825(b)(2)(i)). The replacement “Sequence Listing” must be accompanied by: (1) a statement that the submission does not include any new matter (37 CFR 1.825(b)(5)); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) as originally filed for all amended sequence data in the replacement “Sequence Listing” (37 CFR 1.825(b)(4)); and (3) a statement that identifies the location of all deletions, replacements, or additions to the “Sequence Listing” (37 CFR 1.825(b)(3)). See generally 37 CFR 1.825.

In situations where an applicant is filing an amendment to a “Sequence Listing” via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(b), the Office recommends filing a replacement “Sequence Listing” as an ASCII plain text file where the applicant requests that the replacement “Sequence Listing” text file be entered using an incorporation by reference statement (37 CFR 1.825(b)(2)(i)). The replacement “Sequence Listing” must be accompanied by: (1) a statement that the submission does not include any new matter (37 CFR 1.825(b)(5)); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) as originally filed for all amended sequence data in the replacement “Sequence Listing” (37 CFR 1.825(b)(4)); and (3) a statement that identifies the location of all deletions, replacements, or additions to the “Sequence Listing” (37 CFR 1.825(b)(3)). See generally 37 CFR 1.825.

In situations where an applicant is filing an amendment to a “Sequence Listing” via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(b), the Office recommends filing a replacement “Sequence Listing” as an ASCII plain text file where the applicant requests that the replacement “Sequence Listing” text file be entered using an incorporation by reference statement (37 CFR 1.825(b)(2)(i)). The replacement “Sequence Listing” must be accompanied by: (1) a statement that the submission does not include any new matter (37 CFR 1.825(b)(5)); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) as originally filed for all amended sequence data in the replacement “Sequence Listing” (37 CFR 1.825(b)(4)); and (3) a statement that identifies the location of all deletions, replacements, or additions to the “Sequence Listing” (37 CFR 1.825(b)(3)). See generally 37 CFR 1.825.

Any “Sequence Listing” or CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.821(c) or (e), will be excluded when determining the application size fee required by 37 CFR 1.16(s) or 1.492(j) as per 37 CFR 1.52(f)(1)(i). A “Sequence Listing” submitted as a PDF image file via the USPTO patent electronic filing system will not be excluded when determining the application size fee.

One hundred (100) megabytes is the size limit for a “Sequence Listing” or a CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system; for nearly all other file types, 25 megabytes is the size limit. This includes a 25 megabytes size limit for ASCII plain text files for a “Computer Program Listing Appendix” and “Large Tables” (see 37 CFR 1.58(c) and 1.96(c)). This limit, however, may not prevent an entirely electronic submission. According to the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework), a user may be able to break up a file of a ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ that is larger than 25 MB into multiple files that are no larger than 25 MB each and submit those smaller files via the USPTO patent electronic filing system. If the user chooses to break up a large ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ file so it may be submitted electronically, the file names must indicate their order (e.g., ‘‘1 of X,’’ ‘‘2 of X’’). Files above the 25 MB limit for ‘‘Large Tables’’ and a ‘‘Computer Program Listing Appendix’’ (unless capable of being divided) and above 100 MB for a ‘‘Sequence Listing’’ must be submitted on read-only optical discs.

One hundred (100) megabytes is the size limit for a “Sequence Listing” or a CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system; for nearly all other file types, 25 megabytes is the size limit. This includes a 25 megabytes size limit for ASCII plain text files for a “Computer Program Listing Appendix” and “Large Tables” (see 37 CFR 1.58(c) and 1.96(c)). This limit, however, may not prevent an entirely electronic submission. According to the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework), a user may be able to break up a file of a ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ that is larger than 25 MB into multiple files that are no larger than 25 MB each and submit those smaller files via the USPTO patent electronic filing system. If the user chooses to break up a large ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ file so it may be submitted electronically, the file names must indicate their order (e.g., ‘‘1 of X,’’ ‘‘2 of X’’). Files above the 25 MB limit for ‘‘Large Tables’’ and a ‘‘Computer Program Listing Appendix’’ (unless capable of being divided) and above 100 MB for a ‘‘Sequence Listing’’ must be submitted on read-only optical discs.

One hundred (100) megabytes is the size limit for a “Sequence Listing” or a CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system; for nearly all other file types, 25 megabytes is the size limit. This includes a 25 megabytes size limit for ASCII plain text files for a “Computer Program Listing Appendix” and “Large Tables” (see 37 CFR 1.58(c) and 1.96(c)). This limit, however, may not prevent an entirely electronic submission. According to the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework), a user may be able to break up a file of a ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ that is larger than 25 MB into multiple files that are no larger than 25 MB each and submit those smaller files via the USPTO patent electronic filing system. If the user chooses to break up a large ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ file so it may be submitted electronically, the file names must indicate their order (e.g., ‘‘1 of X,’’ ‘‘2 of X’’). Files above the 25 MB limit for ‘‘Large Tables’’ and a ‘‘Computer Program Listing Appendix’’ (unless capable of being divided) and above 100 MB for a ‘‘Sequence Listing’’ must be submitted on read-only optical discs.

Submission of a ‘‘Sequence Listing’’ or a CRF of a “Sequence Listing” as an ASCII plain text file, if it exceeds 100 MB, cannot be divided like a submission of a ‘‘Large Table’’ or a ‘‘Computer Program Listing Appendix.’’ Thus, any “Sequence Listing” or CRF of a “Sequence Listing” greater than 100 MB must be submitted on read-only optical discs. If a user submits an electronic copy of a file that exceeds these size limits on a read-only optical disc(s), it is recommended that the read-only optical disc(s) be submitted via Priority Mail Express® from the USPS in accordance with 37 CFR 1.10, or hand delivery, on the date of the corresponding USPTO patent electronic filing system filing in accordance with 37 CFR 1.52(e) if the user wishes the electronic copy to be considered to be part of the application as filed.

See MPEP § 2422.03(a)(III) et seq. for further guidance on “Sequence Listing” size limits. See the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework) for additional information pertaining to limits on the number and size of files submitted via the USPTO patent electronic filing system. See also MPEP § 502.05.

See MPEP § 2422.03(a)(III) et seq. for further guidance on “Sequence Listing” size limits. See the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework) for additional information pertaining to limits on the number and size of files submitted via the USPTO patent electronic filing system. See also MPEP § 502.05.

A “Sequence Listing XML” may be submitted as a XML file with a “.xml” extension via the USPTO patent electronic filing system or as read-only optical discs in compliance with 37 CFR 1.52(e) and 1.831(a). Such submission requires that applicant provide a statement in a separate paragraph that incorporates by reference the material in the XML file identifying the name of the XML file, the date of creation, and the size of the XML file in bytes (except that an incorporation by reference statement is not required for a sequence listing properly submitted as an XML file in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage). A “Sequence Listing XML” under 37 CFR 1.831 through 1.839 may be submitted as an XML file only in applications filed on or after July 1, 2022. See 2022 Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications To Implement WIPO Standard ST.26; Incorporation by Reference, 87 FR 30806 (May 20, 2022). The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing” under 37 CFR 1.821 through 1.825 for applications filed before July 1, 2022, see subsection I above.

Applications filed on or after July 1, 2022 that contain disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b) must provide such sequence information as a “Sequence Listing XML” submitted as an XML file (37 CFR 1.831(a)), where the “Sequence Listing XML” complies with the requirements of 37 CFR 1.831 – 1.834. The “Sequence Listing XML” may be filed via the USPTO patent electronic filing system using Patent Center which is available at www.uspto.gov/PatentCenter.

If the notice pursuant to 37 CFR 1.835(d)(1) identifies an error in a previously submitted “Sequence Listing XML,” or applicant needs to revise the “Sequence Listing XML,” applicant can submit a replacement “Sequence Listing XML” along with: (1) a request to amend the specification to include an incorporation by reference statement of the material in the replacement “Sequence Listing XML” (37 CFR 1.835(b)(2)); (2) a statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced “Sequence Listing XML” (37 CFR 1.835(b)(3)); (3) a statement that identifies the basis for the additions, deletions, or replacements of the sequence information with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all amended sequence data in the replacement “Sequence Listing XML” (37 CFR 1.835(b)(4)); and (4) a statement of no new matter (37 CFR 1.835(b)(5)). See generally 37 CFR 1.835.

If the notice pursuant to 37 CFR 1.835(d)(1) identifies an error in a previously submitted “Sequence Listing XML,” or applicant needs to revise the “Sequence Listing XML,” applicant can submit a replacement “Sequence Listing XML” along with: (1) a request to amend the specification to include an incorporation by reference statement of the material in the replacement “Sequence Listing XML” (37 CFR 1.835(b)(2)); (2) a statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced “Sequence Listing XML” (37 CFR 1.835(b)(3)); (3) a statement that identifies the basis for the additions, deletions, or replacements of the sequence information with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all amended sequence data in the replacement “Sequence Listing XML” (37 CFR 1.835(b)(4)); and (4) a statement of no new matter (37 CFR 1.835(b)(5)). See generally 37 CFR 1.835.

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

For “Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a CRF of a “Sequence Listing,” the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a “.txt” extension. See 37 CFR 1.58(d)(4), 1.96(c)(2), and 1.824(a)(3) (providing the requirements for the file name). For a “Sequence Listing XML,” the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A “Sequence Listing XML” must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a “.xml” extension. See 37 CFR 1.834(a) (providing the requirements for the file name).

Each read-only optical disc must be compatible with PC or Mac ® computers and with MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ® operating systems. The files contained on each read-only optical disc must be in ASCII plain text format (“Computer Program Listing Appendix’’, ‘‘Large Tables’’ or “Sequence Listing”) or XML file format (“Sequence Listing XML”). If the ASCII plain text file is compressed, the file must be compressed in accordance with 37 CFR 1.58, 1.96, and 1.824. If the “Sequence Listing XML” file is compressed, the file must be compressed in accordance with 37 CFR 1.834. See 37 CFR 1.52(e)(3).

Each read-only optical disc must be compatible with PC or Mac ® computers and with MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ® operating systems. The files contained on each read-only optical disc must be in ASCII plain text format (“Computer Program Listing Appendix’’, ‘‘Large Tables’’ or “Sequence Listing”) or XML file format (“Sequence Listing XML”). If the ASCII plain text file is compressed, the file must be compressed in accordance with 37 CFR 1.58, 1.96, and 1.824. If the “Sequence Listing XML” file is compressed, the file must be compressed in accordance with 37 CFR 1.834. See 37 CFR 1.52(e)(3).

Each read-only optical disc must be compatible with PC or Mac ® computers and with MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ® operating systems. The files contained on each read-only optical disc must be in ASCII plain text format (“Computer Program Listing Appendix’’, ‘‘Large Tables’’ or “Sequence Listing”) or XML file format (“Sequence Listing XML”). If the ASCII plain text file is compressed, the file must be compressed in accordance with 37 CFR 1.58, 1.96, and 1.824. If the “Sequence Listing XML” file is compressed, the file must be compressed in accordance with 37 CFR 1.834. See 37 CFR 1.52(e)(3).

Each read-only optical disc must be compatible with PC or Mac ® computers and with MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ® operating systems. The files contained on each read-only optical disc must be in ASCII plain text format (“Computer Program Listing Appendix’’, ‘‘Large Tables’’ or “Sequence Listing”) or XML file format (“Sequence Listing XML”). If the ASCII plain text file is compressed, the file must be compressed in accordance with 37 CFR 1.58, 1.96, and 1.824. If the “Sequence Listing XML” file is compressed, the file must be compressed in accordance with 37 CFR 1.834. See 37 CFR 1.52(e)(3).

Read-only optical discs submitted to the Office will not be returned to the applicant and may not be retained as part of the patent application file. See 37 CFR 1.52(e)(6). Read-only optical discs containing submitted “Large Tables” or a “Computer Program Listing Appendix” must be submitted in duplicate and labeled as “Copy 1” and “Copy 2,” respectively. See 37 CFR 1.58(i) and 1.96(c)(7). Read-only optical discs submitted for a “Sequence Listing,” CRF of a “Sequence Listing,” or a “Sequence Listing XML” are not required to be submitted in duplicate because a “Sequence Listing,” CRF of a “Sequence Listing,” or a “Sequence Listing XML” is processed differently than “Large Tables” or a “Computer Program Listing Appendix”.

Read-only optical discs submitted to the Office will not be returned to the applicant and may not be retained as part of the patent application file. See 37 CFR 1.52(e)(6). Read-only optical discs containing submitted “Large Tables” or a “Computer Program Listing Appendix” must be submitted in duplicate and labeled as “Copy 1” and “Copy 2,” respectively. See 37 CFR 1.58(i) and 1.96(c)(7). Read-only optical discs submitted for a “Sequence Listing,” CRF of a “Sequence Listing,” or a “Sequence Listing XML” are not required to be submitted in duplicate because a “Sequence Listing,” CRF of a “Sequence Listing,” or a “Sequence Listing XML” is processed differently than “Large Tables” or a “Computer Program Listing Appendix”.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

1. This form paragraph must be used to indicate whenever a data file (“Large Table”, ”Computer Program Listing Appendix” or “Sequence Listing”) is submitted in a non-ASCII file format. The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file may contain non-ASCII characters.

1. This form paragraph must be used to indicate whenever a data file (“Large Table”, ”Computer Program Listing Appendix” or “Sequence Listing”) is submitted in a non-ASCII file format. The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file may contain non-ASCII characters.

1. This form paragraph must be used whenever a data file (“Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a “Sequence Listing XML” (as applicable) is submitted in a non-ASCII file format or a non-XML file format (as applicable). The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file contains non-ASCII characters or fails to comply with the requirements for a “Sequence Listing XML” submitted under 1.52(e).

1. This form paragraph must be used whenever a data file (“Large Tables,” a “Computer Program Listing Appendix,” a “Sequence Listing,” or a “Sequence Listing XML” (as applicable) is submitted in a non-ASCII file format or a non-XML file format (as applicable). The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file contains non-ASCII characters or fails to comply with the requirements for a “Sequence Listing XML” submitted under 1.52(e).

For greater detail on submission of a read-only optical disc in a “Sequence Listing”, a “Sequence Listing XML,” “Large Tables”, or a “Computer Program Listing Appendix”, see MPEP § 608.05(a)-(c).

The granted patent or pre-grant publication of an application that includes an ASCII plain text file or XML file, whether submitted on optical read-only discs or via the USPTO patent electronic filing system, may not include the actual contents of the ASCII plain text file or XML file in the printed document. The incorporation by reference is necessary to treat the material in the ASCII plain text file or XML file as part of the patent or publication and to alert the public that the granted patent or the pre-grant publication includes additional material that constitutes part of the patent or publication. See 37 CFR 1.52(e)(8), 1.58(d)(5), 1.77(b)(5), 1.96(c), 1.821(c)(1), and 1.834(c)(1) (provides the incorporation by reference requirement).

The granted patent or pre-grant publication of an application that includes an ASCII plain text file or XML file, whether submitted on optical read-only discs or via the USPTO patent electronic filing system, may not include the actual contents of the ASCII plain text file or XML file in the printed document. The incorporation by reference is necessary to treat the material in the ASCII plain text file or XML file as part of the patent or publication and to alert the public that the granted patent or the pre-grant publication includes additional material that constitutes part of the patent or publication. See 37 CFR 1.52(e)(8), 1.58(d)(5), 1.77(b)(5), 1.96(c), 1.821(c)(1), and 1.834(c)(1) (provides the incorporation by reference requirement).

For “Large Tables” submitted as an ASCII plain text file via the USPTO patent electronic filing system, the “Large Tables” will be considered as part of the rest of the specification and drawings such that the paper size equivalent will be considered to be 75% of the number of sheets of paper present in the specification and drawings in the application when entered into the electronic file wrapper after being rendered by the USPTO patent electronic filing system. See 37 CFR 1.52(f)(2) and MPEP § 607, subsection II.

A read-only optical disc submitted under 37 CFR 1.52(e) is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii)) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

A read-only optical disc submitted under 37 CFR 1.52(e) is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii)) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

A read-only optical disc submitted under 37 CFR 1.52(e) is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii)) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

A read-only optical disc submitted under 37 CFR 1.52(e) is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii)) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

A read-only optical disc submitted under 37 CFR 1.52(e) is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii)) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

A read-only optical disc submitted under 37 CFR 1.52(e) is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii)) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

37 CFR 1.52(e)(4) requires that each read-only optical disc must be enclosed in a hard case within an unsealed padded and protective mailing envelope and accompanied by a transmittal letter in accordance with 37 CFR 1.52(e)(4). The transmittal letter must include the following information: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) the operating system (MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ®) used to produce the disc; and 6) the files contained on the read-only optical disc, including the name of the file, the size of the file in bytes, and the date of creation. Each read-only optical disc must have a permanent label affixed thereto on which the following information has been hand-printed or typed: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) date on which the data were recorded on the read-only optical disc; and 6) disc order (e.g., “1 of X”) if multiple read-only optical discs are submitted.

The following document types may be submitted as ASCII text files with a “.txt” extension via the USPTO patent electronic filing system or on read-only optical discs in compliance with 37 CFR 1.52(e) and 1.58, 1.96(c), or 1.821 et seq. provided the specification contains a statement in a separate paragraph that incorporates by reference the material in the ASCII text file identifying the name of the ASCII text file, the date of creation, and the size of the ASCII text file in bytes (except that an incorporation by reference statement is not required for a “Sequence Listing” properly submitted as an ASCII plain text file in an international application (PCT) during the international stage regardless of whether the application is currently in the international stage or the national stage):

• (1) A “Computer Program Listing Appendix” (see 37 CFR 1.96(c)). It is noted that a “Computer Program Listing Appendix” cannot be filed in ASCII plain text in an international application (PCT) during the international stage;
• (2) A “Sequence Listing” (see 37 CFR 1.821(c)(1)). Note that a CRF of a “Sequence Listing” filed pursuant to 37 CFR 1.821(e) must be filed as an ASCII plain text file, but an incorporation by reference statement is required because a CRF is not part of the specification; or
• (3) “Large Tables” (see 37 CFR 1.58(c)).

A “Sequence Listing XML” may be submitted as a XML file with a “.xml” extension via the USPTO patent electronic filing system or as read-only optical discs in compliance with 37 CFR 1.52(e) and 1.831 et seq. Such submission requires that applicant provide a statement in a separate paragraph that incorporates by reference the material in the XML file identifying the name of the XML file, the date of creation, and the size of the XML file in bytes (except that an incorporation by reference statement is not required for a Sequence Listing properly submitted as an XML file in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage).

Further, the specification must contain an incorporation by reference statement of the material in the ASCII plain text file in a separate paragraph identifying the name of the ASCII plain text file, the date of creation, and the size of the ASCII text file in bytes (except for a “Sequence Listing” submitted in an international application (PCT) during the international stage regardless of whether the application is currently in the international stage or the national stage and a CRF of a “Sequence Listing” submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8), 1.58(d)(5), 1.77(b)(5), 1.96(c), and 1.821(c)(1).

The Office recommends that a “Sequence Listing” filed via the USPTO patent electronic filing system be submitted in an ASCII plain text file (37 CFR 1.821(c)(1)). It is noted that while submission of the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is permitted, the inclusion of such would be part of the specification and would count toward the calculation for application size fee in accordance with 37 CFR 1.16(s). Should applicant file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) in an application submitted under 35 U.S.C. 111(a) or file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) and not also as an ASCII plain text file (37 CFR 1.821(c)(1)) in a national stage application submitted under 35 U.S.C. 371, a separate submission of a computer readable form (CRF) of the “Sequence Listing” would be required (37 CFR 1.821(e)(1) or (e)(2)). When a separate CRF is required under 37 CFR 1.821(e)(1) or (e)(2), a statement that the sequence information contained in the CRF and the information in the “Sequence Listing” submitted as a PDF or on physical sheets of paper are identical is required (37 CFR 1.821(e)(1)(ii) or 37 CFR 1.821(e)(2)(ii)). It is noted that an applicant can no longer request a CRF transfer from a parent application when applicant submitted a “Sequence Listing” under 37 CFR 1.821(c)(2) or 1.821(c)(3) (see “ Electronic Submission of a Sequence Listing, a Large Table, or a Computer Program Listing Appendix in Patent Applications, ” 86 FR 57035, 57038 (October 14, 2021)). Checker software that may be used to check a sequence listing for compliance with the requirements of 37 CFR 1.824 is available on the USPTO website at www.uspto.gov/Checker4.

A “Sequence Listing XML” may be submitted as a XML file with a “.xml” extension via the USPTO patent electronic filing system or as read-only optical discs in compliance with 37 CFR 1.52(e) and 1.831(a). Such submission requires that applicant provide a statement in a separate paragraph that incorporates by reference the material in the XML file identifying the name of the XML file, the date of creation, and the size of the XML file in bytes (except that an incorporation by reference statement is not required for a sequence listing properly submitted as an XML file in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage). A “Sequence Listing XML” under 37 CFR 1.831 through 1.839 may be submitted as an XML file only in applications filed on or after July 1, 2022. See 2022 Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications To Implement WIPO Standard ST.26; Incorporation by Reference, 87 FR 30806 (May 20, 2022). The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing” under 37 CFR 1.821 through 1.825 for applications filed before July 1, 2022, see subsection I above.

A “Sequence Listing” under 37 CFR 1.821 through 1.825 may be submitted as an ASCII plain text file only in applications filed before July 1, 2022. The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing XML” under 37 CFR 1.831 through 1.839 for applications filed on or after July 1, 2022, see subsection II below.

The Office recommends that a “Sequence Listing” filed via the USPTO patent electronic filing system be submitted in an ASCII plain text file (37 CFR 1.821(c)(1)). It is noted that while submission of the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is permitted, the inclusion of such would be part of the specification and would count toward the calculation for application size fee in accordance with 37 CFR 1.16(s). Should applicant file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) in an application submitted under 35 U.S.C. 111(a) or file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) and not also as an ASCII plain text file (37 CFR 1.821(c)(1)) in a national stage application submitted under 35 U.S.C. 371, a separate submission of a computer readable form (CRF) of the “Sequence Listing” would be required (37 CFR 1.821(e)(1) or (e)(2)). When a separate CRF is required under 37 CFR 1.821(e)(1) or (e)(2), a statement that the sequence information contained in the CRF and the information in the “Sequence Listing” submitted as a PDF or on physical sheets of paper are identical is required (37 CFR 1.821(e)(1)(ii) or 37 CFR 1.821(e)(2)(ii)). It is noted that an applicant can no longer request a CRF transfer from a parent application when applicant submitted a “Sequence Listing” under 37 CFR 1.821(c)(2) or 1.821(c)(3) (see “ Electronic Submission of a Sequence Listing, a Large Table, or a Computer Program Listing Appendix in Patent Applications, ” 86 FR 57035, 57038 (October 14, 2021)). Checker software that may be used to check a sequence listing for compliance with the requirements of 37 CFR 1.824 is available on the USPTO website at www.uspto.gov/Checker4.

For international applications that contain a disclosure of one or more nucleotide and/or amino acid sequences, PCT Rule 5.2(a) requires a sequence listing as a separate part of the description. When filing a sequence listing in an international application (PCT) that was filed before July 1, 2022 using the USPTO patent electronic filing system, the sequence listing part of the description may be submitted either as a single ASCII plain text file with a ".txt" extension (e.g., "seqlist.txt") or as a PDF image file. Note that 100 megabytes is the size limit for submitting a sequence listing ASCII plain text file via the USPTO patent electronic filing system. See MPEP § 2422.03(a)(IV) for further information regarding filing a sequence listing in international applications via the USPTO patent electronic filing system.

A “Sequence Listing XML” may be submitted as a XML file with a “.xml” extension via the USPTO patent electronic filing system or as read-only optical discs in compliance with 37 CFR 1.52(e) and 1.831(a). Such submission requires that applicant provide a statement in a separate paragraph that incorporates by reference the material in the XML file identifying the name of the XML file, the date of creation, and the size of the XML file in bytes (except that an incorporation by reference statement is not required for a sequence listing properly submitted as an XML file in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage). A “Sequence Listing XML” under 37 CFR 1.831 through 1.839 may be submitted as an XML file only in applications filed on or after July 1, 2022. See 2022 Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications To Implement WIPO Standard ST.26; Incorporation by Reference, 87 FR 30806 (May 20, 2022). The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing” under 37 CFR 1.821 through 1.825 for applications filed before July 1, 2022, see subsection I above.

One hundred (100) megabytes is the size limit for a “Sequence Listing” or a CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system; for nearly all other file types, 25 megabytes is the size limit. This includes a 25 megabytes size limit for ASCII plain text files for a “Computer Program Listing Appendix” and “Large Tables” (see 37 CFR 1.58(c) and 1.96(c)). This limit, however, may not prevent an entirely electronic submission. According to the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework), a user may be able to break up a file of a ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ that is larger than 25 MB into multiple files that are no larger than 25 MB each and submit those smaller files via the USPTO patent electronic filing system. If the user chooses to break up a large ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ file so it may be submitted electronically, the file names must indicate their order (e.g., ‘‘1 of X,’’ ‘‘2 of X’’). Files above the 25 MB limit for ‘‘Large Tables’’ and a ‘‘Computer Program Listing Appendix’’ (unless capable of being divided) and above 100 MB for a ‘‘Sequence Listing’’ must be submitted on read-only optical discs.

One hundred (100) megabytes is the size limit for a “Sequence Listing” or a CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system; for nearly all other file types, 25 megabytes is the size limit. This includes a 25 megabytes size limit for ASCII plain text files for a “Computer Program Listing Appendix” and “Large Tables” (see 37 CFR 1.58(c) and 1.96(c)). This limit, however, may not prevent an entirely electronic submission. According to the Legal Framework for Patent Electronic System (www.uspto.gov/PatentLegalFramework), a user may be able to break up a file of a ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ that is larger than 25 MB into multiple files that are no larger than 25 MB each and submit those smaller files via the USPTO patent electronic filing system. If the user chooses to break up a large ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ file so it may be submitted electronically, the file names must indicate their order (e.g., ‘‘1 of X,’’ ‘‘2 of X’’). Files above the 25 MB limit for ‘‘Large Tables’’ and a ‘‘Computer Program Listing Appendix’’ (unless capable of being divided) and above 100 MB for a ‘‘Sequence Listing’’ must be submitted on read-only optical discs.

Read-only optical discs submitted to the Office will not be returned to the applicant and may not be retained as part of the patent application file. See 37 CFR 1.52(e)(6). Read-only optical discs containing submitted “Large Tables” or a “Computer Program Listing Appendix” must be submitted in duplicate and labeled as “Copy 1” and “Copy 2,” respectively. See 37 CFR 1.58(i) and 1.96(c)(7). Read-only optical discs submitted for a “Sequence Listing,” CRF of a “Sequence Listing,” or a “Sequence Listing XML” are not required to be submitted in duplicate because a “Sequence Listing,” CRF of a “Sequence Listing,” or a “Sequence Listing XML” is processed differently than “Large Tables” or a “Computer Program Listing Appendix”.

1. Use this form paragraph when the transmittal letter does not include a listing of the files and required information.

(b) The specification should include the following sections in order:

• (1) Title of the invention, which may be accompanied by an introductory portion stating the name, citizenship, and residence of the applicant (unless included in the application data sheet).
• (2) Cross-reference to related applications.
• (3) Statement regarding federally sponsored research or development.
• (4) The names of the parties to a joint research agreement.
• (5) An incorporation by reference statement regarding the material in:
  • (i) One or more ASCII plain text files, submitted via the USPTO patent electronic filing system or on one or more read-only optical discs (see § 1.52(e)(8)), identifying the names of each file, the date of creation of each file, and the size of each file in bytes, for the following document types:
    • (A) A “Computer Program Listing Appendix” (see § 1.96(c));
    • (B) A “Sequence Listing” (see § 1.821(c)); or
    • (C) “Large Tables” (see § 1.58(c)).
  • (ii) An XML file for a “Sequence Listing XML” (see § 1.831(a)), submitted via the USPTO patent electronic filing system or on one or more read-only optical discs (see § 1.52(e)(8)), identifying the names of each file, the date of creation of each file, and the size of each file in bytes.
  • (iii)
• (6) Statement regarding prior disclosures by the inventor or a joint inventor.
• (7) Background of the invention.
• (8) Brief summary of the invention.
• (9) Brief description of the several views of the drawing.
• (10) Detailed description of the invention.
• (11) A claim or claims.
• (12) Abstract of the disclosure.
• (13) "Sequence Listing," required by § 1.821(c), that is submitted as a Portable Document Format (PDF) file (as set forth in § 1.821(c)(2)) via the USPTO patent electronic filing system or on physical sheets of paper (as set forth in § 1.821(c)(3)).

(c) The text of the specification sections defined in paragraphs (b)(1) through (b)(12) of this section, if applicable, should be preceded by a section heading in uppercase and without underlining or bold type.

1. Use this form paragraph when a read-only optical disc or text file submitted via the USPTO patent electronic filing system is filed with an amendment, but the required incorporation-by-reference statement is neither amended nor added to the specification.

Any “Sequence Listing” or CRF of a “Sequence Listing” submitted as an ASCII plain text file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.821(c) or (e), will be excluded when determining the application size fee required by 37 CFR 1.16(s) or 1.492(j) as per 37 CFR 1.52(f)(1)(i). A “Sequence Listing” submitted as a PDF image file via the USPTO patent electronic filing system will not be excluded when determining the application size fee.

Any “Computer Program Listing Appendix” submitted as an ASCII plain text file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.96(c) will be excluded when determining the application size fee required by 37 CFR 1.16(s) or 1.492(j) as per 37 CFR 1.52(f)(1)(ii).

Any “Sequence Listing XML” submitted as an XML file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.831(a) will be excluded when determining the application size fee required by 37 CFR 1.16(s) or 1.492(j) as per 37 CFR 1.52(f)(2)(i).

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

Any amendment to the information on a read-only optical disc must be by way of a replacement read-only optical disc, in compliance with 37 CFR 1.58(g) for “Large Tables”, 37 CFR 1.96(c)(5) for a “Computer Program Listing Appendix”, and 37 CFR 1.825(b) for a “Sequence Listing” or a CRF of a “Sequence Listing”, and 37 CFR 1.835(b) for a “Sequence Listing XML”. See 37 CFR 1.52(e)(7). When the information is filed on a read-only optical disc initially, amendments cannot be made to the information using the USPTO patent electronic filing system, but instead must be made using a replacement read-only optical disc. The amendment should include a corresponding amendment to the description of the incorporation by reference statement in the specification when an incorporation by reference is necessary or present. A replacement read-only optical disc containing the amended file(s) must also contain all of the files of the original read-only optical disc that were not amended (if any). This will ensure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest electronic version of the file(s) provided in the replacement read-only optical disc.

Any amendment to the information on a read-only optical disc must be by way of a replacement read-only optical disc, in compliance with 37 CFR 1.58(g) for “Large Tables”, 37 CFR 1.96(c)(5) for a “Computer Program Listing Appendix”, and 37 CFR 1.825(b) for a “Sequence Listing” or a CRF of a “Sequence Listing”, and 37 CFR 1.835(b) for a “Sequence Listing XML”. See 37 CFR 1.52(e)(7). When the information is filed on a read-only optical disc initially, amendments cannot be made to the information using the USPTO patent electronic filing system, but instead must be made using a replacement read-only optical disc. The amendment should include a corresponding amendment to the description of the incorporation by reference statement in the specification when an incorporation by reference is necessary or present. A replacement read-only optical disc containing the amended file(s) must also contain all of the files of the original read-only optical disc that were not amended (if any). This will ensure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest electronic version of the file(s) provided in the replacement read-only optical disc.

Any amendment to the information on a read-only optical disc must be by way of a replacement read-only optical disc, in compliance with 37 CFR 1.58(g) for “Large Tables”, 37 CFR 1.96(c)(5) for a “Computer Program Listing Appendix”, and 37 CFR 1.825(b) for a “Sequence Listing” or a CRF of a “Sequence Listing”, and 37 CFR 1.835(b) for a “Sequence Listing XML”. See 37 CFR 1.52(e)(7). When the information is filed on a read-only optical disc initially, amendments cannot be made to the information using the USPTO patent electronic filing system, but instead must be made using a replacement read-only optical disc. The amendment should include a corresponding amendment to the description of the incorporation by reference statement in the specification when an incorporation by reference is necessary or present. A replacement read-only optical disc containing the amended file(s) must also contain all of the files of the original read-only optical disc that were not amended (if any). This will ensure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest electronic version of the file(s) provided in the replacement read-only optical disc.

A “Sequence Listing” under 37 CFR 1.821 through 1.825 may be submitted as an ASCII plain text file only in applications filed before July 1, 2022. The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing XML” under 37 CFR 1.831 through 1.839 for applications filed on or after July 1, 2022, see subsection II below.

A “Sequence Listing XML” may be submitted as a XML file with a “.xml” extension via the USPTO patent electronic filing system or as read-only optical discs in compliance with 37 CFR 1.52(e) and 1.831(a). Such submission requires that applicant provide a statement in a separate paragraph that incorporates by reference the material in the XML file identifying the name of the XML file, the date of creation, and the size of the XML file in bytes (except that an incorporation by reference statement is not required for a sequence listing properly submitted as an XML file in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage). A “Sequence Listing XML” under 37 CFR 1.831 through 1.839 may be submitted as an XML file only in applications filed on or after July 1, 2022. See 2022 Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications To Implement WIPO Standard ST.26; Incorporation by Reference, 87 FR 30806 (May 20, 2022). The applicable filing date is either the filing date under 37 CFR 1.53 for applications submitted under 35 U.S.C. 111 or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a “Sequence Listing” under 37 CFR 1.821 through 1.825 for applications filed before July 1, 2022, see subsection I above.

In situations where an applicant is adding a “Sequence Listing” via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(a) after the application filing date, the Office recommends submitting the “Sequence Listing” as an ASCII plain text file along with a request that the amendment be entered using an incorporation by reference statement (37 CFR 1.825(a)(2)(i)). The “Sequence Listing” must be accompanied by a statement that the submission does not include any new matter which goes beyond the disclosure of the application as filed (37 CFR 1.825(a)(4)) and a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) for all sequence data in the “Sequence Listing” in the application as originally filed (37 CFR 1.825(a)(3)).

In situations where an applicant is adding a “Sequence Listing XML” via the USPTO patent electronic filing system in accordance with 37 CFR 1.835(a) after the application filing date, such as when a patent applicant receives a notice under 37 CFR 1.835(d)(1), to comply with the “Sequence Listing XML” regulations (37 CFR 1.831 – 1.834), the applicant must submit the “Sequence Listing XML” as an XML file either via the USPTO patent electronic system or on read-only optical disc. Submission of a “Sequence Listing XML” after the filing date requires that the applicant provide: (1) a request to amend the specification to include an updated incorporation by reference statement of the material in the “Sequence Listing XML” (37 CFR 1.835(a)(2)); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all sequence data in the “Sequence Listing XML” in the application as originally filed (37 CFR 1.835(a)(3)); and (3) a statement of no new matter (37 CFR 1.835(a)(4)).

For international applications that contain a disclosure of one or more nucleotide and/or amino acid sequences, PCT Rule 5.2(a) requires a sequence listing as a separate part of the description. When filing a sequence listing in an international application (PCT) that was filed before July 1, 2022 using the USPTO patent electronic filing system, the sequence listing part of the description may be submitted either as a single ASCII plain text file with a ".txt" extension (e.g., "seqlist.txt") or as a PDF image file. Note that 100 megabytes is the size limit for submitting a sequence listing ASCII plain text file via the USPTO patent electronic filing system. See MPEP § 2422.03(a)(IV) for further information regarding filing a sequence listing in international applications via the USPTO patent electronic filing system.

Material on read-only optical disc(s) filed on the date that the application is accorded a filing date are generally to be treated as part of the originally filed disclosure even if the requisite “incorporation by reference” statement (see 37 CFR 1.77(b)(5)) is omitted. However, in certain instances, the material on the read-only optical disc may not be treated as a part of the disclosure. For example, if a file is unreadable, it is treated as not having been submitted, and thus, it will not be treated as a part of the disclosure. It is noted that an incorporation by reference statement is not required for a “Sequence Listing” submitted as an ASCII plain text file or as an XML file (as applicable) in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage. Also, an incorporation by reference statement is not required for a CRFs of a “Sequence Listings” submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8). The material on the read-only optical disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. If required, the incorporation by reference statement of the material on the read-only optical disc will need to be added via an amendment to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on the read-only optical disc. The examiner should require applicant(s) to insert this statement if it is omitted. See 37 CFR 1.58(h), 1.96(c)(6), 1.825(c), and 1.835(c). However, if the application would otherwise be in condition for allowance, the examiner may insert the statement by examiner’s amendment with a notice of allowance after receiving authorization from the applicant. See MPEP § 1302.04 and 37 CFR 1.121(g).

Material on read-only optical disc(s) filed on the date that the application is accorded a filing date are generally to be treated as part of the originally filed disclosure even if the requisite “incorporation by reference” statement (see 37 CFR 1.77(b)(5)) is omitted. However, in certain instances, the material on the read-only optical disc may not be treated as a part of the disclosure. For example, if a file is unreadable, it is treated as not having been submitted, and thus, it will not be treated as a part of the disclosure. It is noted that an incorporation by reference statement is not required for a “Sequence Listing” submitted as an ASCII plain text file or as an XML file (as applicable) in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage. Also, an incorporation by reference statement is not required for a CRFs of a “Sequence Listings” submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8). The material on the read-only optical disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. If required, the incorporation by reference statement of the material on the read-only optical disc will need to be added via an amendment to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on the read-only optical disc. The examiner should require applicant(s) to insert this statement if it is omitted. See 37 CFR 1.58(h), 1.96(c)(6), 1.825(c), and 1.835(c). However, if the application would otherwise be in condition for allowance, the examiner may insert the statement by examiner’s amendment with a notice of allowance after receiving authorization from the applicant. See MPEP § 1302.04 and 37 CFR 1.121(g).

Material on read-only optical disc(s) filed on the date that the application is accorded a filing date are generally to be treated as part of the originally filed disclosure even if the requisite “incorporation by reference” statement (see 37 CFR 1.77(b)(5)) is omitted. However, in certain instances, the material on the read-only optical disc may not be treated as a part of the disclosure. For example, if a file is unreadable, it is treated as not having been submitted, and thus, it will not be treated as a part of the disclosure. It is noted that an incorporation by reference statement is not required for a “Sequence Listing” submitted as an ASCII plain text file or as an XML file (as applicable) in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage. Also, an incorporation by reference statement is not required for a CRFs of a “Sequence Listings” submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8). The material on the read-only optical disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. If required, the incorporation by reference statement of the material on the read-only optical disc will need to be added via an amendment to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on the read-only optical disc. The examiner should require applicant(s) to insert this statement if it is omitted. See 37 CFR 1.58(h), 1.96(c)(6), 1.825(c), and 1.835(c). However, if the application would otherwise be in condition for allowance, the examiner may insert the statement by examiner’s amendment with a notice of allowance after receiving authorization from the applicant. See MPEP § 1302.04 and 37 CFR 1.121(g).

Material on read-only optical disc(s) filed on the date that the application is accorded a filing date are generally to be treated as part of the originally filed disclosure even if the requisite “incorporation by reference” statement (see 37 CFR 1.77(b)(5)) is omitted. However, in certain instances, the material on the read-only optical disc may not be treated as a part of the disclosure. For example, if a file is unreadable, it is treated as not having been submitted, and thus, it will not be treated as a part of the disclosure. It is noted that an incorporation by reference statement is not required for a “Sequence Listing” submitted as an ASCII plain text file or as an XML file (as applicable) in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage. Also, an incorporation by reference statement is not required for a CRFs of a “Sequence Listings” submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8). The material on the read-only optical disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. If required, the incorporation by reference statement of the material on the read-only optical disc will need to be added via an amendment to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on the read-only optical disc. The examiner should require applicant(s) to insert this statement if it is omitted. See 37 CFR 1.58(h), 1.96(c)(6), 1.825(c), and 1.835(c). However, if the application would otherwise be in condition for allowance, the examiner may insert the statement by examiner’s amendment with a notice of allowance after receiving authorization from the applicant. See MPEP § 1302.04 and 37 CFR 1.121(g).

Material on read-only optical disc(s) filed on the date that the application is accorded a filing date are generally to be treated as part of the originally filed disclosure even if the requisite “incorporation by reference” statement (see 37 CFR 1.77(b)(5)) is omitted. However, in certain instances, the material on the read-only optical disc may not be treated as a part of the disclosure. For example, if a file is unreadable, it is treated as not having been submitted, and thus, it will not be treated as a part of the disclosure. It is noted that an incorporation by reference statement is not required for a “Sequence Listing” submitted as an ASCII plain text file or as an XML file (as applicable) in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage. Also, an incorporation by reference statement is not required for a CRFs of a “Sequence Listings” submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8). The material on the read-only optical disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. If required, the incorporation by reference statement of the material on the read-only optical disc will need to be added via an amendment to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on the read-only optical disc. The examiner should require applicant(s) to insert this statement if it is omitted. See 37 CFR 1.58(h), 1.96(c)(6), 1.825(c), and 1.835(c). However, if the application would otherwise be in condition for allowance, the examiner may insert the statement by examiner’s amendment with a notice of allowance after receiving authorization from the applicant. See MPEP § 1302.04 and 37 CFR 1.121(g).

(a) The elements of the application, if applicable, should appear in the following order:

• (1) Utility application transmittal form.
• (2) Fee transmittal form.
• (3) Application data sheet (see § 1.76).
• (4) Specification.
• (5) Drawings.
• (6) The inventor’s oath or declaration.

It is noted that “Large Tables” cannot be filed in ASCII plain text in an international application (PCT) during the international stage (see 37 CFR 1.58(c)).

The Office recommends that a “Sequence Listing” filed via the USPTO patent electronic filing system be submitted in an ASCII plain text file (37 CFR 1.821(c)(1)). It is noted that while submission of the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is permitted, the inclusion of such would be part of the specification and would count toward the calculation for application size fee in accordance with 37 CFR 1.16(s). Should applicant file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) in an application submitted under 35 U.S.C. 111(a) or file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) and not also as an ASCII plain text file (37 CFR 1.821(c)(1)) in a national stage application submitted under 35 U.S.C. 371, a separate submission of a computer readable form (CRF) of the “Sequence Listing” would be required (37 CFR 1.821(e)(1) or (e)(2)). When a separate CRF is required under 37 CFR 1.821(e)(1) or (e)(2), a statement that the sequence information contained in the CRF and the information in the “Sequence Listing” submitted as a PDF or on physical sheets of paper are identical is required (37 CFR 1.821(e)(1)(ii) or 37 CFR 1.821(e)(2)(ii)). It is noted that an applicant can no longer request a CRF transfer from a parent application when applicant submitted a “Sequence Listing” under 37 CFR 1.821(c)(2) or 1.821(c)(3) (see “ Electronic Submission of a Sequence Listing, a Large Table, or a Computer Program Listing Appendix in Patent Applications, ” 86 FR 57035, 57038 (October 14, 2021)). Checker software that may be used to check a sequence listing for compliance with the requirements of 37 CFR 1.824 is available on the USPTO website at www.uspto.gov/Checker4.

The Office recommends that a “Sequence Listing” filed via the USPTO patent electronic filing system be submitted in an ASCII plain text file (37 CFR 1.821(c)(1)). It is noted that while submission of the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is permitted, the inclusion of such would be part of the specification and would count toward the calculation for application size fee in accordance with 37 CFR 1.16(s). Should applicant file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) in an application submitted under 35 U.S.C. 111(a) or file the “Sequence Listing” as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) and not also as an ASCII plain text file (37 CFR 1.821(c)(1)) in a national stage application submitted under 35 U.S.C. 371, a separate submission of a computer readable form (CRF) of the “Sequence Listing” would be required (37 CFR 1.821(e)(1) or (e)(2)). When a separate CRF is required under 37 CFR 1.821(e)(1) or (e)(2), a statement that the sequence information contained in the CRF and the information in the “Sequence Listing” submitted as a PDF or on physical sheets of paper are identical is required (37 CFR 1.821(e)(1)(ii) or 37 CFR 1.821(e)(2)(ii)). It is noted that an applicant can no longer request a CRF transfer from a parent application when applicant submitted a “Sequence Listing” under 37 CFR 1.821(c)(2) or 1.821(c)(3) (see “ Electronic Submission of a Sequence Listing, a Large Table, or a Computer Program Listing Appendix in Patent Applications, ” 86 FR 57035, 57038 (October 14, 2021)). Checker software that may be used to check a sequence listing for compliance with the requirements of 37 CFR 1.824 is available on the USPTO website at www.uspto.gov/Checker4.

In situations where an applicant is adding a “Sequence Listing” via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(a) after the application filing date, the Office recommends submitting the “Sequence Listing” as an ASCII plain text file along with a request that the amendment be entered using an incorporation by reference statement (37 CFR 1.825(a)(2)(i)). The “Sequence Listing” must be accompanied by a statement that the submission does not include any new matter which goes beyond the disclosure of the application as filed (37 CFR 1.825(a)(4)) and a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) for all sequence data in the “Sequence Listing” in the application as originally filed (37 CFR 1.825(a)(3)).

Submission of a ‘‘Sequence Listing’’ or a CRF of a “Sequence Listing” as an ASCII plain text file, if it exceeds 100 MB, cannot be divided like a submission of a ‘‘Large Table’’ or a ‘‘Computer Program Listing Appendix.’’ Thus, any “Sequence Listing” or CRF of a “Sequence Listing” greater than 100 MB must be submitted on read-only optical discs. If a user submits an electronic copy of a file that exceeds these size limits on a read-only optical disc(s), it is recommended that the read-only optical disc(s) be submitted via Priority Mail Express® from the USPS in accordance with 37 CFR 1.10, or hand delivery, on the date of the corresponding USPTO patent electronic filing system filing in accordance with 37 CFR 1.52(e) if the user wishes the electronic copy to be considered to be part of the application as filed.

Applications filed on or after July 1, 2022 that contain disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b) must provide such sequence information as a “Sequence Listing XML” submitted as an XML file (37 CFR 1.831(a)), where the “Sequence Listing XML” complies with the requirements of 37 CFR 1.831 – 1.834. The “Sequence Listing XML” may be filed via the USPTO patent electronic filing system using Patent Center which is available at www.uspto.gov/PatentCenter.

In situations where an applicant is adding a “Sequence Listing XML” via the USPTO patent electronic filing system in accordance with 37 CFR 1.835(a) after the application filing date, such as when a patent applicant receives a notice under 37 CFR 1.835(d)(1), to comply with the “Sequence Listing XML” regulations (37 CFR 1.831 – 1.834), the applicant must submit the “Sequence Listing XML” as an XML file either via the USPTO patent electronic system or on read-only optical disc. Submission of a “Sequence Listing XML” after the filing date requires that the applicant provide: (1) a request to amend the specification to include an updated incorporation by reference statement of the material in the “Sequence Listing XML” (37 CFR 1.835(a)(2)); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all sequence data in the “Sequence Listing XML” in the application as originally filed (37 CFR 1.835(a)(3)); and (3) a statement of no new matter (37 CFR 1.835(a)(4)).

37 CFR 1.52(e)(4) requires that each read-only optical disc must be enclosed in a hard case within an unsealed padded and protective mailing envelope and accompanied by a transmittal letter in accordance with 37 CFR 1.52(e)(4). The transmittal letter must include the following information: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) the operating system (MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ®) used to produce the disc; and 6) the files contained on the read-only optical disc, including the name of the file, the size of the file in bytes, and the date of creation. Each read-only optical disc must have a permanent label affixed thereto on which the following information has been hand-printed or typed: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) date on which the data were recorded on the read-only optical disc; and 6) disc order (e.g., “1 of X”) if multiple read-only optical discs are submitted.

37 CFR 1.52(e)(4) requires that each read-only optical disc must be enclosed in a hard case within an unsealed padded and protective mailing envelope and accompanied by a transmittal letter in accordance with 37 CFR 1.52(e)(4). The transmittal letter must include the following information: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) the operating system (MS-DOS ®, MS-Windows ®, Mac OS ®, or Unix ® /Linux ®) used to produce the disc; and 6) the files contained on the read-only optical disc, including the name of the file, the size of the file in bytes, and the date of creation. Each read-only optical disc must have a permanent label affixed thereto on which the following information has been hand-printed or typed: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) date on which the data were recorded on the read-only optical disc; and 6) disc order (e.g., “1 of X”) if multiple read-only optical discs are submitted.

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., “1 of X”). See 37 CFR 1.52(e)(5) (includes other labeling requirements). Read-only optical disc(s) copies containing “Large Tables” and/or a “Computer Program Listing Appendix” should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML” Listings” should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For “Large Tables” and a “Computer Program Listing Appendix” where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a “Sequence Listing”, a CRF of a “Sequence Listing”, or a “Sequence Listing XML”, PLRC loads the “Sequence Listing”, the CRF of the “Sequence Listing”, or the “Sequence Listing XML” into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

Any amendment to the information on a read-only optical disc must be by way of a replacement read-only optical disc, in compliance with 37 CFR 1.58(g) for “Large Tables”, 37 CFR 1.96(c)(5) for a “Computer Program Listing Appendix”, and 37 CFR 1.825(b) for a “Sequence Listing” or a CRF of a “Sequence Listing”, and 37 CFR 1.835(b) for a “Sequence Listing XML”. See 37 CFR 1.52(e)(7). When the information is filed on a read-only optical disc initially, amendments cannot be made to the information using the USPTO patent electronic filing system, but instead must be made using a replacement read-only optical disc. The amendment should include a corresponding amendment to the description of the incorporation by reference statement in the specification when an incorporation by reference is necessary or present. A replacement read-only optical disc containing the amended file(s) must also contain all of the files of the original read-only optical disc that were not amended (if any). This will ensure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest electronic version of the file(s) provided in the replacement read-only optical disc.