Requirements for content of a “Sequence Listing” part of the specification.
37 C.F.R. § 1.823
in effectEffective: 2024-07-01(a) The “Sequence Listing” must comply with the following:
(1) The order and presentation of the items of information in the “Sequence Listing” shall conform to the arrangement in appendix G to this subpart. The submission of those items of information designated with an “M” is mandatory. The submission of those items of information designated with an “O” is optional.
(2) Each item of information shall begin on a new line, with the numeric identifier enclosed in angle brackets, as shown in appendix G to this subpart.
(3) Set forth numeric identifiers <110> through <170> at the beginning of the “Sequence Listing.”
(4) Include each disclosed nucleotide and/or amino acid sequence, as defined in § 1.821(a).
(5) Assign a separate sequence identifier to each sequence, beginning with 1 and increasing sequentially by integers, and include the sequence identifier in numeric identifier <210>.
(6) Use the code “000” in place of the sequence where no sequence is present for a sequence identifier.
(7) Include the total number of SEQ ID NOs in numeric identifier <160>, as defined in appendix G to this subpart, whether followed by a sequence or by the code “000.”
(8) Must not contain more than 74 characters per line.
(b)(1) Unless paragraph (b)(2) of this section applies, if the “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc, in compliance with § 1.52(e), then the specification must contain a statement in a separate paragraph (see § 1.77(b)(5)) that incorporates by reference the material in the ASCII plain text file identifying:
(i) The name of the file;
(ii) The date of creation; and
(iii) The size of the file in bytes.
(2) If the “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc, in compliance with § 1.52(e) for an international application during the international stage, then incorporation by reference of the material in the ASCII plain text file is not required.
(3) A “Sequence Listing” required by § 1.821(c) that is submitted as a PDF file (§ 1.821(c)(2)) via the USPTO patent electronic filing system or on physical sheets of paper (§ 1.821(c)(3)), setting forth the nucleotide and/or amino acid sequence and associated information in accordance with paragraph (a) of this section:
(i) Must begin on a new page;
(ii) Must be titled “Sequence Listing”;
(iii) Must not include material other than the “Sequence Listing” itself;
(iv) Must have sheets containing no more than 66 lines, with each line containing no more than 74 characters;
(v) Should have sheets numbered independently of the numbering of the remainder of the application; and
(vi) Should use a fixed-width font exclusively throughout.
Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-37.xmlFetched: 7/26/2026