MPEP § 2424 – Requirements for Content of a "Sequence Listing" Part of the Specification under WIPO ST.25.

[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. (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. (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. (3) Set forth numeric identifiers <110> through <170> at the beginning of the "Sequence Listing."
4. (4) Include each disclosed nucleotide and/or amino acid sequence, as defined in § 1.821(a).
5. (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. (6) Use the code "000" in place of the sequence where no sequence is present for a sequence identifier.
7. (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. (8) Must not contain more than 74 characters per line.
(b)
1. (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:
  1. (i) The name of the file;
  2. (ii) The date of creation; and
  3. (iii) The size of the file in bytes.
2. (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. (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:
  1. (i) Must begin on a new page;
  2. (ii) Must be titled "Sequence Listing";
  3. (iii) Must not include material other than the "Sequence Listing" itself;
  4. (iv) Must have sheets containing no more than 66 lines, with each line containing no more than 74 characters;
  5. (v) Should have sheets numbered independently of the numbering of the remainder of the application; and
  6. (vi) Should use a fixed-width font exclusively throughout.

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.

37 CFR 1.823 sets forth the informational requirements for the content of a "Sequence Listing" part of the specification that must be submitted in accordance with 37 CFR 1.821(c) as part of the application. See MPEP § 2422.03 for a discussion of 37 CFR 1.821(c).

37 CFR 1.823(a) sets forth the content requirements for a "Sequence Listing". Such requirements include, but are not limited to, sequence identifiers, the order and presentation of items of information, mandatory and optional information, the format as to line spacing, and the use of numeric identifiers.

37 CFR 1.823(b)(1) sets forth a requirement for applications, other than an international application in the international stage, to contain, in the specification of the patent application, an express incorporation by reference of the material submitted as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc(s) identifying the name of the file, the date of creation, and the size of the file in bytes.

37 CFR 1.823(b)(2) specifically exempts international applications during the international stage from the incorporation by reference requirement in 37 CFR 1.823(b)(1).

37 CFR 1.823(b)(3) sets forth the format and content for a "Sequence Listing" that is submitted either as a PDF image file via the USPTO patent electronic filing system or on physical sheets of paper, in accordance with 37 CFR 1.823(b)(1)(i) -(vi).

37 CFR 1.823(a) sets forth the order and presentation of the items of information in the "Sequence Listing". Each item of information in the "Sequence Listing" must include the appropriate numeric identifier and its accompanying information as in Appendix G to Subpart G of Part 1. Each item of information must begin on a new line with the numeric identifier enclosed in angle brackets. 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. Numeric identifiers <110> through <170> must be set forth at the beginning of the "Sequence Listing".

See MPEP § 2431 for a sample "Sequence Listing".

Throughout 37 CFR 1.823(a), the items of information relating to patent applications and patent publications should be provided keeping in mind the appropriate standards that have been established by the World Intellectual Property Organization (WIPO). In general, an application should be identified by a country code, a number and a filing date, while a published patent document should be identified by a country code, a number and kind code. Proper citation of priority patent applications is covered in MPEP § 214.04. For published patent documents, the country code, number and kind code will appear on the front page of the document. Unpublished PCT applications are identified by the letters PCT, the country code of the Receiving Office, and the four digit year of filing and a six digit number, e.g., PCT/SE2011/000123. A published PCT application is identified by the letters WO, the four digit year of publication and a six digit number, e.g. WO/2015/009167. Country codes from WIPO Standard ST.3 Annex A and kind codes from WIPO Standard ST.16 are accessible on WIPO’s website (www.wipo.int/standards/en/part_03_standards.html ). See also MPEP § 1851. Questions on proper citation of patent documents should be directed to staff in the Office of International Patent Legal Administration.

See Appendix G to Subpart G of Part 1 of the CFR (reproduced in MPEP § 2424) for information regarding numeric identifiers.