37 CFR 1.825 — Amendments to add or replace a “Sequence Listing” and CRF copy thereof

Ninth Edition, Revision 01.2024

[Editor Note: This rule is applicable to applications containing a nucleotide and/or amino acid sequence filed prior to July 1, 2022. See §§ 1.831 through 1.835 for rules applicable on or after July 1, 2022.]

• (a) Any amendment adding a “Sequence Listing” (§ 1.821(c) ) after the application filing date must include:
  • (1) A “Sequence Listing,” in accordance with the requirements of §§ 1.821 through 1.824 , submitted as:
    • (i) An ASCII plain text file, under § 1.821(c)(1) , via the USPTO patent electronic filing system or on a read-only optical disc, in compliance with § 1.52(e) ;
    • (ii) A PDF file via the USPTO patent electronic filing system; or
    • (iii) Physical sheets of paper;
  • (2) A request that the amendment be made:
    • (i) By incorporation by reference of the material in the ASCII plain text file, in a separate paragraph of the specification, identifying the name of the file, the date of creation, and the size of the file in bytes ( see § 1.77(b)(5) ), for a "Sequence Listing" submitted under § 1.821(c)(1) , except when submitted to the United States International Preliminary Examining Authority for an international application; or
    • (ii) By inserting, after the abstract of the disclosure, a “Sequence Listing” submitted as a PDF file under § 1.821(c)(2) or submitted on physical sheets of paper under § 1.821(c)(3) , except when submitted to the United States International Preliminary Examining Authority for an international application;
  • (3) A statement that indicates the basis for the amendment, with specific references to particular parts of the application (specification, claims, drawings) for all sequence data in the “Sequence Listing” in the application as originally filed;
  • (4) A statement that the “Sequence Listing” includes no new matter;
  • (5) A new or substitute CRF under § 1.821(e) , if:
    • (i) (The added “Sequence Listing” is submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper, under § 1.821(c)(3) ; and
    • (ii) A CRF, under § 1.821(e) , was not submitted, not compliant with § 1.824 , or not the same as the “Sequence Listing”; and
  • (6) A statement that the sequence information contained in the CRF is the same as the sequence information contained in the added “Sequence Listing,” if submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper, under § 1.821(c)(3) .
• (b) Any amendment to a “Sequence Listing” (§ 1.821(c) ) must include:
  • (1) A replacement “Sequence Listing,” in accordance with the requirements of §§ 1.821 through 1.824 , submitted as:
    • (i) An ASCII plain text file, under § 1.821(c)(1) , via the USPTO patent electronic filing system, or on a read-only optical disc, in compliance with § 1.52(e) , labeled as “REPLACEMENT MM/DD/YYYY” (with the month, day, and year of creation indicated);
    • (ii) A PDF file via the USPTO patent electronic filing system; or
    • (iii) Physical sheets of paper;
  • (2) A request that the amendment be made:
    • (i) By incorporation by reference of the material in the ASCII plain text file, in a separate paragraph of the specification (replacing any prior such paragraph, as applicable) identifying the name of the file, the date of creation, and the size of the file in bytes (see § 1.77(b)(5) ) for a “Sequence Listing” under § 1.821(c)(1) , except when submitted to the United States International Preliminary Examining Authority for an international application; or
    • (ii) By placing, after the abstract of the disclosure, a “Sequence Listing” submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper, under § 1.821(c)(3) (replacing any prior “Sequence Listing,” as applicable), except when submitted to the United States International Preliminary Examining Authority for an international application;
  • (3) A statement that identifies the location of all deletions, replacements, or additions to the “Sequence Listing”;
  • (4) A statement that indicates the basis for the amendment, with specific references to particular parts of the application (specification, claims, drawings) as originally filed for all amended sequence data in the replacement “Sequence Listing”;
  • (5) A statement that the replacement “Sequence Listing” includes no new matter;
  • (6) A new or substitute CRF, under § 1.821(e), with the amendment incorporated therein, if:
    • (i) The replacement “Sequence Listing” is submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper, under § 1.821(c)(3) ; and
    • (ii) A CRF, under § 1.821(e) , was not submitted, not compliant with § 1.824 , or not the same as the submitted “Sequence Listing”; and
  • (7) A statement that the sequence information contained in the CRF is the same as the sequence information contained in the replacement “Sequence Listing” when submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper, under § 1.821(c)(3) .
• (c) The specification of a complete application, filed on the application filing date, with a “Sequence Listing” as an ASCII plain text file, under § 1.821(c)(1) , without an incorporation by reference of the material contained in the ASCII plain text file, must be amended to contain a separate paragraph incorporating by reference the material contained in the ASCII plain text file, in accordance with § 1.77(b)(5) , except for international applications during the international stage or national stage.
• (d) Any appropriate amendments to the “Sequence Listing” in a patent ( e.g., by reason of reissue, reexamination, or a certificate of correction) must comply with the requirements of paragraph (b) of this section.

[Added 55 FR 18230, May 1, 1990, effective Oct. 1, 1990; revised, 63 FR 29620, June 1, 1998, effective July 1, 1998; paras. (a) and (b) revised, 65 FR 54604, Sept. 8, 2000, effective Sept. 8, 2000 (effective date corrected, 65 FR 78958, Dec. 18, 2000); para. (d) revised, 68 FR 14332, Mar. 25, 2003, effective May 1, 2003; revised, 86 FR 57035, Oct. 14, 2021, effective Nov. 15, 2021]