37 CFR 1.823 — Requirements for content of a “Sequence Listing” part of the specification

Ninth Edition, Revision 01.2024

[Editor Note: This rule is applicable to applications containing a nucleotide and/or amino acid sequence filed prior to July 1, 2022. See §§ 1.831 through 1.835 for rules applicable on or after July 1, 2022.]

• (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.

[Added, 55 FR 18230, May 1, 1990, effective Oct. 1, 1990; revised, 63 FR 29620, June 1, 1998, effective July 1, 1998; heading and para. (a) revised, 65 FR 54604, Sept. 8, 2000, effective Sept. 8, 2000 (effective date corrected, 65 FR 78958, Dec. 18, 2000); para. (a)(1) revised, 68 FR 38611, June 30, 2003, effective July 30, 2003; revised, 86 FR 57035, Oct. 14, 2021, effective Nov. 15, 2021]