2415.01 Determining if a “Sequence Listing XML” Must be Submitted [R-01.2024]

[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

An application filed under 35 U.S.C. 111(a) that has a filing date on or after July 1, 2022, or an application which entered the national stage, having an international filing date on or after July 1, 2022, will be required to provide a “Sequence Listing XML” in accordance with 37 CFR 1.831 through 1.835 for disclosures of any nucleotide and/or amino acid sequences that meet the definitions of 37 CFR 1.831(a) and (b). This includes applications having filing date or international filing date on or after July 1, 2022, that claim benefit or priority to applications with filing dates before July 1, 2022. Such applications include, but are not limited to, applications having one or more benefit or priority claims under 35 U.S.C. 119(e) (claiming the benefit of a provisional), 35 U.S.C. 120 (claiming the benefit as a continuation and/or continuation-in-part), 37 CFR 1.121 (claiming the benefit as a divisional), 35 U.S.C. 365(c) (claiming the benefit as a continuing application to a PCT application), or 35 U.S.C. 119(a)–(d) or 35 U.S.C. 365(a) (claiming the priority to a foreign filed application or a prior filed PCT). If a prior application to which benefit or priority is claimed contains a “Sequence Listing” in Standard ST.25 format (in compliance with 37 CFR 1.821 through 1.825), the applicant will be required to transform that “Sequence Listing” into WIPO Standard ST.26 format (a “Sequence Listing XML” in compliance with 37 CFR 1.831 through 1.835) for inclusion in the new application filed on or after July 1, 2022.

As provided in 35 U.S.C. 363, the filing date of an international stage application is also the filing date for the national stage application filed under 35 U.S.C. 371. Accordingly, for applications submitted under 35 U.S.C. 371, WIPO Standard ST.26 will apply to such applications based on the international filing date of the corresponding international application, rather than the date of submission of the national stage application in the USPTO. See also MPEP § 1893.03(b).

Compliance with 37 CFR 1.831 through 1.835 (rules based on WIPO Standard ST.26) is also applicable to any reissue application filed on or after July 1, 2022, where the disclosure or claims contain nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(a) or (b). The filing date of the originally granted patent for which reissue is sought is not relevant in determining the applicability date of 37 CFR 1.831-1.835.

Relying on the actual filing date of an application to determine whether sequence information must conform to 37 CFR 1.821 through 1.825 (rules based on WIPO Standard ST.25) or 37 CFR 1.831 through 1.835 (rules based on WIPO Standard ST.26) simplifies the application of the sequence rules, both for the USPTO and the applicant. Though 37 CFR 1.821 through 1.825 remain applicable for applications with a filing date before July 1, 2022, those provisions will not be applicable to applications filed on or after July 1, 2022.

2415.02 Provisional Applications Containing Disclosures of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.834 [R-01.2024]

[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

Similar to the rules of practice regarding provisional applications filed before July 1, 2022, that contain disclosures of nucleotide and/or amino acid sequences, provisional applications filed on or after July 1, 2022, are not required to contain a separate compliant sequence listing. However, if an applicant chooses to file a separate sequence listing in an application filed on or after July 1, 2022, the submission must be by way of a “Sequence Listing XML” that is compliant with 37 CFR 1.831 - 1.834. Provisional applications cannot be amended, so if a provisional application contains a non-compliant “Sequence Listing XML” no notice relating to the requirements will be mailed in the application.

2415.03 Improper Submissions of “Sequence Listing” under 1.821(c) When a “Sequence Listing XML” was Required [R-01.2024]

[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

While implementing regulations and procedures for WIPO Standard ST.26, the USPTO recognized that an applicant might erroneously provide a “Sequence Listing” in ASCII plain text file format even though a “Sequence Listing XML” is required. Therefore, in the rare circumstance in which a “Sequence Listing” .txt file is submitted in an application filed on or after July 1, 2022, the “Sequence Listing” present in the Office file wrapper of the application at issue may be used to provide support for the submission of a compliant “Sequence Listing XML.” The applicant’s reliance on the “Sequence Listing” to support the compliant “Sequence Listing XML” would be by way of the safeguard under 37 CFR 1.57(b), if an earlier filed application contains a proper “Sequence Listing” in .txt file format, or via a grantable petition under 37 CFR 1.182, only if the application does not have a proper benefit or priority claim present on the filing date to an earlier filed application.

An applicant may rely on the provisions in 37 CFR 1.57(b), as described in the MPEP § 217, to support the required “Sequence Listing XML” as an “inadvertently omitted portion of the specification or drawing(s).” To rely on 37 CFR 1.57(b), a compliant “Sequence Listing” must have been submitted in an earlier filed application to which the present application makes a proper benefit or priority claim, and the “Sequence Listing” was present on the filing date of the earlier filed application (i.e., the earlier filed application contains a compliant “Sequence Listing” submitted under 37 CFR 1.821(c)(1) as an ASCII plain text file (with a proper incorporation by reference statement in the specification), 37 CFR 1.821(c)(2) as a PDF file, or 37 CFR 1.821(c)(3) on physical sheets of paper). An applicant would be required to submit: (1) A compliant “Sequence Listing XML” under 37 CFR 1.835(a)(1); (2) a statement identifying where the inadvertently omitted portion of the specification can be found (e.g., identifying the nucleotide and/or amino acid sequence information in the compliant “Sequence Listing” from the earlier filed application that forms the basis for the “Sequence Listing XML”), see 37 CFR 1.835(a)(3); (3) a statement identifying the nucleotide and/or amino acid sequences of the “Sequence Listing,” submitted (in the earlier filed application) under 37 CFR 1.821(c)(1) as an ASCII plain text file (with a proper incorporation by reference statement in the specification), 37 CFR 1.821(c)(2) as a PDF file, or 37 CFR 1.821(c)(3) as physical sheets of paper, which forms the basis for the compliant “Sequence Listing XML”; (4) a statement that the “Sequence Listing XML” does not introduce new matter into the application, see 37 CFR 1.835(a)(4); and (5) a statement that all or a portion of the specification or drawings, as found in the “Sequence Listing XML,” were inadvertently omitted from the application. The availability of relief under 37 CFR 1.57(b) precludes the filing of a grantable petition under 37 CFR 1.182 seeking the same relief.

A petition under 37 CFR 1.182 would require: (1) a compliant “Sequence Listing XML” under 37 CFR 1.835(a)(1); (2) a statement identifying the nucleotide and/or amino acid sequence information of the “Sequence Listing” erroneously submitted as an ASCII plain text file that is relied on for submission of a compliant “Sequence Listing XML,” (i.e., identifying the nucleotide and/or amino acid sequence information found in the “Sequence Listing XML” within the erroneously submitted ASCII “Sequence Listing”) see 37 CFR 1.835(a)(3); and (3) a statement that the “Sequence Listing XML” does not introduce new matter into the application, as required by 37 CFR 1.835(a)(4). In such circumstances, for record retention purposes, any “Sequence Listing” submitted as an ASCII plain text file will be retained in the official record for the application.