MPEP § 2424 — Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25. (Annotated Rules)
§2424 Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.
This page consolidates and annotates all enforceable requirements under MPEP § 2424, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.
This section addresses Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25. Primary authority: 37 CFR 1.823. Contains: 2 requirements and 3 other statements.
Key Rules
Sequence Listing Format
(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.
(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.
(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.
(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.
Sequence Listing Content
[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.]
(a) The “Sequence Listing” must comply with the following:
…
(6) Use the code “000” in place of the sequence where no sequence is present for a sequence identifier.
Citations
| Primary topic | Citation |
|---|---|
| Sequence Listing Format | 37 CFR § 1.821(a) |
| Sequence Listing Content | 37 CFR § 1.831(b) |
| Sequence Listing Content | MPEP § 2412 |
Source Text from USPTO’s MPEP
This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.
Official MPEP § 2424 — Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.
Source: USPTO2424 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 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.
- (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. |