2414.02 Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a) [R-07.2022]

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byChhabra Law Firm

2414.02 Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a) [R-07.2022]

[Editor Note: This section is applicable to all 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).]

37 CFR 1.835 Amendment to add or replace a “Sequence Listing XML” in patent applications filed on or after July 1, 2022.

  • (a) Any amendment to a patent application adding an initial submission of a “Sequence Listing XML” as required by § 1.831(a) after the application filing date must include:
    • (1) A “Sequence Listing XML” in accordance with §§ 1.831 through 1.834, submitted as an XML file:
      • (i) Via the USPTO patent electronic filing system; or
      • (ii) On a read-only optical disc, in compliance with § 1.52(e);
    • (2) A request to amend the specification to include an incorporation by reference statement of the material in the “Sequence Listing XML” file, identifying the name of the file, the date of creation, and the size of the file in bytes (see § 1.77(b)(5)(ii)), 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 as originally filed (specification, claims, drawings) for all sequence data in the “Sequence Listing XML”; and
    • (4) A statement that the “Sequence Listing XML” includes no new matter.

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Part of the pre-examination process as well as initial review by the examiner involves identifying whether an application that discloses nucleotides and/or amino acids requires submission of a “Sequence Listing XML”, and if so, if it contains a compliant “Sequence Listing XML.” If pre-examination staff identifies that a “Sequence Listing XML” is required but missing or that compliance with 37 CFR 1.831 – 1.834 is lacking, a notice indicating the deficiencies will be issued to the applicant. Similarly, upon having a new application placed on the examiner’s docket, the examiner can assess whether a disclosure of nucleotides and/or amino acids in the application requires a “Sequence Listing XML” to be submitted where one has not been submitted. The examiner can identify the requirement for a “Sequence Listing XML” on an “OPAP Routing Sheet” (Document Code “SEQREQ”) and return the application to pre-examination for the mailing of a notice indicating the deficiencies.

Applicant response to a notice or an Office Action requiring an added initial “Sequence Listing XML” would involve providing the following:

  • (1) A compliant “Sequence Listing XML” submitted as an XML file using either the USPTO Patent Electronic Filing System (currently, XML files can only be submitted via Patent Center) or a read-only optical disc that is mailed into the Office. If the size of “Sequence Listing XML” file exceeds the upload limit of Patent Center, then it must be submitted on read-only optical disc. (37 CFR 1.835(a)(1));
  • (2) An amendment to the specification to incorporate by reference the material in the XML file containing the “Sequence Listing XML” by reciting in a separate paragraph of the specification the name of the file, the date of creation, and the size of the file in bytes (37 CFR 1.835(a)(2) and 37 CFR 1.835(c));
  • (3) A statement identifying the basis for the added “Sequence Listing XML,” which would include, e.g., pages of originally filed specification where a sequence is disclosed or originally filed drawing sheets identifying the sequence which is part of the “Sequence Listing XML” (37 CFR 1.835(a)(3)); and
  • (4) A statement that no new matter is introduced by the content of the XML file containing the “Sequence Listing XML” (37 CFR 1.835(a)(4)).