2415.03 Improper Submissions of “Sequence Listing” under 1.821(c)(1)-(3) When a “Sequence Listing XML” was Required [R-07.2022]

[Editor Note: This section is applicable to all applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

While implementing regulations and procedures for ST.26, the USPTO recognized that an applicant might erroneously provide a “Sequence Listing” (one in ASCII plain text file format) even though a “Sequence Listing XML” is required. Therefore, in the rare circumstance in which a “Sequence Listing” 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” submitted as an ASCII plain text file that forms the basis for the “Sequence Listing XML” (i.e., identifying the nucleotide and/or amino acid sequence information found in the “Sequence Listing” from the earlier submitted ASCII “Sequence Listing”) that is relied on for submission of a compliant “Sequence Listing XML,” 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.