§ 1.823 - Requirements for content of a “Sequence Listing” part of the specification.

§ 1.823 Requirements for nucleotide and/or amino acid sequences as content of a “Sequence Listing” part of the application.

Cross Reference

Link to an amendment published at 86 FR 57050, Oct. 14, 2021.

specification.

(a) The “Sequence Listing” must comply with the following:

(1) If the “Sequence Listing” required by § 1.821(c) is submitted on paper: The “Sequence Listing,” setting forth the 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

and associated information in accordance with paragraph (b) of this section, must begin on a new page and must be titled “Sequence Listing.” The pages of the “Sequence Listing” preferably should be numbered independently of the numbering of the remainder of the application. Each page of the “Sequence Listing” shall contain no more than 66 lines and each line shall contain no more than 72 characters. The sheet or sheets presenting a sequence listing may not include material other than part of the sequence listing. A fixed-width font should be used exclusively throughout the “Sequence Listing.” (2) If

, 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

on compact disc: The “Sequence Listing” must be submitted on a compact disc

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)

. The compact disc may also contain table information if the application contains table information that may be submitted on a compact disc (§ 1.52(e)(1)(iii)). The specification must contain an incorporation-by-reference of the Sequence Listing as required by § 1.52(e)(5). The presentation of the “Sequence Listing” and other materials on compact disc under

, 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)

does not substitute for the Computer Readable Form that must be submitted on disk, compact disc, or tape in accordance

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.

824. <308>Database Accession NumberAccession number assigned by database including database nameO. <309>Database Entry DateDate of entry in database; specify as yyyy-mm-dd or MMM-yyyyO. <310>Patent Document NumberDocument number; for patent-type citations only. Specify as, for example, US 07/999,999O. <311>Patent Filing DateDocument filing date, for patent-type citations only; specify as yyyy-mm-ddO. <312>Publication DateDocument publication date, for patent-type citations only; specify as yyyy-mm-ddO. <313>Relevant ResiduesFROM (position) TO (position)O. <400>SequenceSEQ ID NO should follow the numeric identifier and should appear on the line preceding the actual sequenceM.[63 FR 29636, June 1, 1998, as amended at 65 FR 54681, Sept. 8, 2000; 68 FR 38630, June 30, 2003

52(

b) The “Sequence Listing” shall, except as otherwise indicated, include the actual nucleotide and/or amino acid sequence, the numeric identifiers and their accompanying information as shown in the following table. The numeric identifier shall be used only in the “Sequence Listing.” The order and presentation of the items of information in the “Sequence Listing” shall conform to the arrangement given below. Each item of information shall begin on a new line and shall begin with the numeric identifier enclosed in angle brackets as shown. 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>shall only be set forth at the beginning of the “Sequence Listing.” The following table illustrates the numeric identifiers.

Numeric identifier Definition Comments and format Mandatory (M) or optional (O). <110>ApplicantPreferably max. of 10 names; one name per line; preferable format: Surname, Other Names and/or InitialsM. <120>Title of InventionM. <130>File ReferencePersonal file referenceM when filed prior to assignment of appl. number. <140>Current Application NumberSpecify as: US 07/999,999 or PCT/US96/99999M, if available. <141>Current Filing DateSpecify as: yyyy-mm-ddM, if available. <150>Prior Application NumberSpecify as: US 07/999,999 or PCT/US96/99999M, if applicable include priority documents under 35 USC 119 and 120. <151>Prior Application Filing DateSpecify as: yyyy-mm-ddM, if applicable. <160>Number of SEQ ID NOsCount includes total number of SEQ ID NOsM. <170>SoftwareName of software used to create the Sequence ListingO. <210>SEQ ID NO:#:Response shall be an integer representing the SEQ ID NO shownM. <211>LengthRespond with an integer expressing the number of bases or amino acid residuesM. <212>TypeWhether 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 sectionM. <213>OrganismScientific 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 sectionM <220>FeatureLeave 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/KeyProvide appropriate identifier for feature, preferably from WIPO Standard ST.25 (1998), Appendix 2, Tables 5 and 6M, under the following conditions: if “n,” “Xaa,” or a modified or unusual L-amino acid or modified base was used in a sequence. <222>LocationSpecify location within sequence; where appropriate state number of first and last bases/amino acids in featureM, 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 InformationOther relevant information; four lines maximumM, 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 InformationLeave blank after <300>O. <301>AuthorsPreferably max of ten named authors of publication; specify one name per line; preferable format: Surname, Other Names and/or InitialsO. <302>TitleO. <303>JournalO. <304>VolumeO. <305>IssueO. <306>PagesO. <307>DateJournal date on which data published; specify as yyyy-mm-dd, MMM-yyyy or Season-yyyyO.

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.

[86 FR 57050, Oct. 14, 2021]