MPEP 2424
Requirements for Content of a "Sequence Listing" Part of the Specification under WIPO ST.25
Ninth Edition of the MPEP, Revision 07.2022, Last Revised in February 2023
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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 §§ 2412-2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]
37 C.F.R. 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.
- (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:
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. |