2422.03 Sequence Listing Submission [R-07.2015]
37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part of the disclosure, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823. This separate part of the disclosure is referred to as the sequence listing. The sequence listing required pursuant to 37 CFR 1.821(c) may be submitted as an ASCII text file via EFS-Web, on compact disc, as a PDF submitted via EFS-Web, or on paper. The sequence listing required by 37 CFR 1.821(c) is the official copy of the sequence listing. Note that 37 CFR 1.821(e) requires that a copy of the sequence listing referred to in 37 CFR 1.821(c) must also be submitted in computer readable form (CRF) in accordance with the requirements of 37 CFR 1.824.
The Office strongly suggests filing the sequence listing required by 37 CFR 1.821(c) as a text file via EFS-Web. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of 37 CFR 1.824(a)(2) -(6) and (b), and applicant has not filed a sequence listing in a PDF file, the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e). Note that the specification must contain 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. See MPEP § 2422.03(a) for additional information pertaining to EFS-Web submission of sequence listings.
If submitted on paper, the sequence listing is a separate part of the disclosure which must begin on a new page within the specification. A plurality of sequences may, if feasible, be presented on a single page; the separate presentation of both nucleotide and amino acid sequences on the same page is also permitted.
If the official copy of the sequence listing as required by 37 CFR 1.821(c) is submitted on compact disc, the specification must contain an incorporation by reference of the material on the compact disc in a separate paragraph, identifying each compact disc by the names of the file(s) contained on each of the compact discs, their date of creation and their sizes in bytes (37 CFR 1.52(e) ). The total number of compact discs including duplicates and the files on each compact disc shall be specified (37 CFR 1.77(b)(5) ). The sequence listing must be a single document, but the document may be split using software designed to divide a file, that is too large to fit on a single compact disc, into multiple concatenated files. If the user breaks up a sequence listing so that it may be submitted on multiple compact discs, the compact discs must be labeled to indicate their order (e.g., "1 of X", "2 of X").
The compact disc used to submit the sequence listing may also contain table information if the table has more than 50 pages of text. See 37 CFR 1.823(a)(2) and 1.52(e)(1)(iii). The compact disc and duplicate copy must be labeled "Copy 1" and "Copy 2," respectively, and a statement stating that the copies are identical must be included. If the two compact discs are not identical, the Office will use the disc labeled "Copy 1" for further processing ( 37 CFR 1.52(e)(4) ). See also MPEP § 608.05.
If the sequence listing under 37 CFR 1.821(c) is submitted on compact disc, applicant is still required to submit a separate CRF of the sequence listing pursuant to 37 CFR 1.821(e) and 37 CFR 1.824. If the CRF is also submitted on compact disc, applicants will need to submit a total of three copies of the sequence listing (one pursuant to 37 CFR 1.821(c), and two pursuant to 37 CFR 1.821(e) ). The compact disc with the CRF of the sequence listing may be identical to the compact disc submitted under 37 CFR 1.821(c) if the latter compact disc includes only the sequence listing (i.e., no additional content, such as tables).