37 CFR § 1.825 — Amendments to add or replace a “Sequence (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.825 Amendments to add or replace a “Sequence
This page consolidates MPEP guidance interpreting 37 CFR § 1.825, including 93 rules from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Summary
This section provides detailed guidance on amending or replacing sequence listings in reissue applications, ensuring compliance with 37 CFR 1.825 and proper formatting of large tables.
What this section covers
- Defines amendments related to sequence listings in reissue applications.
- Focuses on the core topic of sequence listing requirements for reissue applications.
Key obligations
- Ensure sequence listings are properly formatted and submitted in accordance with 37 CFR 1.825.
- Comply with ASCII plain text format for large tables and other sequence listings.
Practice notes
- Draft and file all sequence listings to be up-to-date and formatted correctly.
- Avoid submitting sequence listings in formats other than ASCII plain text to ensure compliance.
Official MPEP § 1.825 — Amendments to add or replace a “Sequence
Source: USPTOLast Modified: 10/30/2024 08:50:22
1.825 Amendments to add or replace a “Sequence Listing” and CRF copy thereof.
[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) .
- (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.
[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]
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