2426 Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to 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 1.825 Amendments to add or replace a “Sequence Listing” and CRF copy thereof.
- (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).
- (1) A “Sequence Listing,” in accordance with the
requirements of §§ 1.821 through 1.824,
submitted as:
- (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).
- (1) A replacement “Sequence Listing,” in
accordance with the requirements of §§ 1.821
through 1.824, submitted as:
- (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.
37 CFR 1.825 sets forth the procedures for adding or replacing the “Sequence Listing” and the CRF thereof. Under 37 CFR 1.825(a), adding a “Sequence Listing” after the application filing date involves the submission of: (1) a “Sequence Listing” either as a PDF image file, on physical sheets of paper, or as an ASCII plain text file submitted via the USPTO patent electronic filing system or on read-only optical disc(s), (2) a request that the amendment be made by either incorporation by reference in the case of ASCII plain text files or inserting text into the specification in the case of PDF image files or physical sheets of paper, (3) a statement that indicate the basis for the amendment in the application, as originally filed, (4) a statement that the “Sequence Listing” includes no new matter, (5) a new or substitute CRF when the submission is a PDF image file or on physical sheets of paper, 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” when the submission is a PDF image file or on physical sheets of paper. (See MPEP § 2428 for further information and sample statements.) If the “Sequence Listing” is filed as an ASCII plain text file only, thereby serving both as a “Sequence Listing” under 37 CFR 1.821(c) and a CRF under 37 CFR 1.821(e), then an incorporation by reference statement is required in the specification (replacing any prior such paragraph) (see 37 CFR 1.77(b)(5)). If the “Sequence Listing” is filed as a PDF image file or on physical sheets of paper, then the “Sequence Listing” must be placed after the abstract of the disclosure. Also, if the added “Sequence Listing” is submitted as a PDF image file or on physical sheets of paper and a separate CRF under 37 CFR 1.821(e) was either not submitted, not compliant with 37 CFR 1.824, or not the same as the submitted “Sequence Listing”, then a new or substitute separate CRF is required along with a statement that the sequence information contained in the CRF is the same as the sequence information contained in the added “Sequence Listing”. It is noted that an incorporation by reference statement should not be submitted for a separate CRF of a “Sequence Listing” submitted under 37 CFR 1.821(e).
Under 37 CFR 1.825(b), amending the “Sequence Listing” involves the submission of a replacement “Sequence Listing” either as a PDF image file, on physical sheets of paper, or as an ASCII plain text file submitted via the USPTO patent electronic filing system or on read-only optical disc(s), in conjunction with statements that identify the location of all deletions, replacements, or additions to the “Sequence Listing”, indicate the basis for the amendment in the application, as originally filed, and that the replacement “Sequence Listing” includes no new matter. (See MPEP § 2428 for further information and sample statements.) These statements may be made by a registered practitioner, the applicant, an inventor, or the person who actually compares the sequence data on behalf of the aforementioned. It is noted that any amendment to the information on a read-only optical disc must be by the way of a replacement read-only optical disc. 37 CFR 1.52(e)(7). If the replacement “Sequence Listing” is filed as an ASCII plain text file, then an incorporation by reference statement is required in the specification (replacing any prior such paragraph) (see 37 CFR 1.77(b)(5)). If the replacement “Sequence Listing” is filed as a PDF image file or on physical sheets of paper, then the replacement “Sequence Listing” must be placed after the abstract of the disclosure. Also, if the replacement “Sequence Listing” is submitted as a PDF image file or on physical sheets of paper and a separate CRF under 37 CFR 1.821(e) was either not submitted, not compliant with 37 CFR 1.824, or not the same as the submitted “Sequence Listing”, then a new or substitute separate CRF is required along with a statement that the sequence information contained in the CRF is the same as the sequence information contained in the replacement “Sequence Listing”. It is noted that an incorporation by reference statement should not be submitted for a separate CRF of a “Sequence Listing” submitted under 37 CFR 1.821(e). If the “Sequence Listing” required by 37 CFR 1.821(c) was filed on a read-only optical disc that included files in addition to the “Sequence Listing”, a replacement read-only optical disc containing the amended “Sequence Listing” also must contain all of the files of the original read-only optical disc that were not amended. This will ensure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest version.
The requirement for statements regarding the absence of new matter follows current practice relating to the submission of substitute specifications, as set forth in 37 CFR 1.125. 37 CFR 1.825(c) requires that the specification must be amended to contain an incorporation by reference statement of the material contained in a “Sequence Listing” ASCII plain text file if the “Sequence Listing” ASCII plain text file was filed on the application filing date without an incorporation by reference statement, except if the “Sequence Listing” ASCII plain text file was filed on the application filing date of an international application regardless of whether the international application is currently in the international stage or the national stage. 37 CFR 1.825(d) addresses the situation where amendments to the “Sequence Listing” are made after a patent has been granted, e.g., by a certificate of correction, reissue or reexamination, and states that such amendments must comply with the requirements of 37 CFR 1.825(b).
