2422.04 The Requirement for a Computer Readable Copy of the “Sequence Listing” [R-07.2022]

2422.04 The Requirement for a Computer Readable Copy of the “Sequence Listing” [R-07.2022]

[Editor Note: This section is not applicable to 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). See MPEP §§ 2412–2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]

37 CFR 1.821(e) requires the submission of a copy of the “Sequence Listing” in computer readable form (CRF) in an application filed under 35 U.S.C. 111(a) or in a national stage application submitted under 35 U.S.C. 371. A separate computer readable form must be submitted via the USPTO patent electronic filing system or on read-only optical disc(s), as permitted by 37 CFR 1.824(b), when the “Sequence Listing” required by 37 CFR 1.821(c) is submitted as a PDF image file or on physical sheets of paper in a U.S. application filed under 35 U.S.C. 111(a) (see 37 CFR 1.821(e)(1)) or when the “Sequence Listing” required by 37 CFR 1.821(c) is submitted as a PDF image file or on physical sheets of paper and not also submitted as an ASCII plain text file in a national stage application (see 37 CFR 1.821(e)(2)). However, the Office prefers submission of sequence information as an ASCII plain text file via the USPTO patent electronic filing system or on read-only optical disc(s) without a copy of the “Sequence Listing” as a PDF image file or on physical sheets of paper in all applications because such an ASCII submission will serve as both the “Sequence Listing” required by 37 CFR 1.821(c) and the CRF of the “Sequence Listing” required by 37 CFR 1.821(e) and the “Sequence Listing” submitted as an ASCII plain text file will not be included in the application size fee determination under 37 CFR 1.52(f)(1) or (2). See MPEP § 2422.03(a)(I).

The information on the computer readable form will be entered into the Office’s database for searching and printing nucleotide and amino acid sequences. This electronic database will also enable the Office to provide published sequence data, in electronic form, to the National Center for Biotechnology Information (NCBI) for publication in GenBank, and enable NCBI to exchange data with the DNA Data Bank of Japan (DDBJ) and the European Bioinformatics Institute (EBI). It should be noted that the Office’s database complies with the confidentiality requirement imposed by 35 U.S.C. 122. Unpublished pending application sequences are maintained in the database separately from published or patented sequences. That is, the Office will not exchange or make public any information on any sequence until the patent application containing that information is published or matures into a patent, or as otherwise allowed by 35 U.S.C. 122.

The Office may permit correction of the “Sequence Listing” submitted pursuant to 37 CFR 1.821(c), whether on physical sheets of paper or as a PDF image file, at the least, during the pendency of a given application by reference to the computer readable form thereof submitted pursuant to37 CFR 1.821(e) if both the “Sequence Listing” and computer readable form were submitted at the time of filing of the application and the totality of the circumstances otherwise substantiate the proposed correction. A mere discrepancy between the “Sequence Listing” and the computer readable form may not, in and of itself, be sufficient to justify a proposed correction. In this regard, the Office will assume that the computer readable form has been incorporated by reference into the application when the “Sequence Listing” and computer readable form were submitted at the time of filing of the application. The Office will attempt to accommodate or address all correction issues, but it must be kept in mind that the real burden rests with the applicant to ensure that any discrepancies between the “Sequence Listing” and the CRF copy are eliminated or minimized. Applicants should be aware that there will be instances where the applicant may have to suffer the consequences of any discrepancies between the two. It is noted that in an application filed under 35 U.S.C. 111(a) in which applicant has not filed a second copy of the “Sequence Listing” as a PDF image file or on physical sheets of paper (see 37 CFR 1.821(e)(1)), an ASCII plain text file will serve as both the “Sequence Listing” required by 37 CFR 1.821(c) and the CRF required by 37 CFR 1.821(e), eliminating any chance for discrepancies. Filing the “Sequence Listing” as an ASCII plain text file submitted via the USPTO patent electronic filing system that complies with both 37 CFR 1.821(c) and (e) is the Office’s preferred method of receiving a “Sequence Listing”.

The Office does not desire to be bound by a requirement to permanently preserve computer readable forms submitted on read-only optical disc(s) for support, priority or correction purposes. Thus, once use of the CRF by the Office for processing has ended, i.e., once the Office has entered the data contained on the computer readable form into the appropriate database, the Office does not intend to further preserve the CRF submitted by the applicant, and applicant should not expect to have the read-only optical disc(s) returned. See 37 CFR 1.52(e)(6).