2424 Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25. [R-07.2022]

2424 Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25. [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 §§ 24122419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]

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

  • (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.
Appendix G to Subpart G of Part 1 – Numeric Identifiers
Numeric Identifier Definition Comments and format Mandatory (M) or optional (O)
<110> Applicant If Applicant is inventor, then preferably max. of 10 names; one name per line; preferable format: Surname, Other Names and/or Initials. M.
<120> Title of Invention M.
<130> File Reference Personal file reference M when filed prior to assignment or appl. number.
<140> Current Application Number Specify as: US 09/999,999 or PCT/US09/99999 M, if available.
<141> Current Filing Date Specify as: yyyy-mm-dd M, if available.
<150> Prior Application Number Specify as: US 09/999,999 or PCT/US09/99999 M, if applicable include priority documents under 35 U.S.C. 119 and 120.
<151> Prior Application Filing Date Specify as: yyyy-mm-dd M, if applicable.
<160> Number of SEQ ID NOs Count includes total number of SEQ ID NOs M.
<170> Software Name of software used to create the “Sequence Listing” O.
<210> SEQ ID NO:#: Response shall be an integer representing the SEQ ID NO shown M.
<211> Length Respond with an integer expressing the number of bases or amino acid residues M.
<212> Type Whether presented sequence molecule is DNA, RNA, or PRT (protein). If a nucleotide sequence contains both DNA and RNA fragments, the type shall be “DNA.” In addition, the combined DNA/ RNA molecule shall be further described in the <220> to <223> feature section M.
<213> Organism Scientific name, i.e., Genus/species, Unknown or Artificial Sequence. In addition, the “Unknown” or “Artificial Sequence” organisms shall be further described in the <220> to <223> feature section M.
<220> Feature Leave blank after <220>. <221-223> provide for a description of points of biological significance in the sequence M, under the following conditions: If “n,” “Xaa,” or a modified or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is “Artificial Sequence” or “Unknown”; if molecule is combined DNA/ RNA.
<221> Name/Key Provide appropriate identifier for feature, from WIPO Standard ST.25 (2009), Appendices E and F to this subpart M, under the following conditions: If “n,” “Xaa,” or a modified or unusual L-amino acid or modified base was used in a sequence.
<222> Location Specify location within sequence; where appropriate, state number of first and last bases/amino acids in feature M, under the following conditions: If “n,” “Xaa,” or a modified or unusual L-amino acid or modified base was used in a sequence.
<223> Other Information. Other relevant information; four lines maximum. M, under the following conditions: If “n,” “Xaa,” or a modified or unusual L- amino acid or modified base was used in a sequence; if ORGANISM is “Artificial Sequence” or “Unknown”; if molecule is combined DNA/ RNA.
<300> Publication Information Leave blank after <30>. O.
<301> Authors Preferably max. of 10 named authors of publication; specify one name per line; preferable format: Surname, Other Names and/or Initials. O.
<302> Title O.
<303> Journal O.
<304> Volume O.
<305> Issue O.
<306> Pages O.
<307> Date Journal date on which data published; specify as yyyy-mm-dd, MMM-yyyy or Season-yyyy O.
<308> Database Accession Number. Accession number assigned by database, including database name O.
<309> Database Entry Date. Date of entry in database; specify as yyyy-mm-dd or MMM-yyyy O.
<310> Patent Document Number. Document number; for patent-type citations only. Specify as, for example, US 09/ 999,999 O.
<311> Patent Filing Date. Document filing date, for patent-type citations only; specify as yyyy-mm-dd O.
<312> Publication Date. Document publication date, for patent-type citations only; specify as yyyy-mm-dd O.
<313> Relevant Residues. FROM (position) TO (position) O.
<400> Sequence SEQ ID NO should follow the numeric identifier and should appear on the line preceding the actual sequence M.