2414.03 Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) [R-07.2022]

Created On
byChhabra Law Firm

2414.03 Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) [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.

  • *****

  • (b) Any amendment adding to, deleting from, or replacing sequence information in a “Sequence Listing XML” submitted as required by § 1.831(a) must include:
    • (1) A replacement “Sequence Listing XML” in accordance with the requirements of §§ 1.831 through 1.834 containing the entire “Sequence Listing XML,” including any additions, deletions, or replacements of sequence information, which shall be submitted:
      • (i) Via the USPTO patent electronic filing system; or
      • (ii) 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);
    • (2) A request to amend the specification to include an incorporation by reference statement of the material in the replacement “Sequence Listing XML” file that identifies 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 the replacement “Sequence Listing XML” is submitted to the United States International Preliminary Examining Authority for an international application;
    • (3) A statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced “Sequence Listing XML”;
    • (4) A statement that indicates the support for the additions, deletions, or replacements of the sequence information, with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all amended sequence data in the replacement “Sequence Listing XML”; and
    • (5) A statement that the replacement “Sequence Listing XML” includes no new matter.

  • *****

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 contains a compliant “Sequence Listing XML.” If pre-examination staff identifies that a previously submitted “Sequence Listing XML” contains errors or fails to comply with 37 CFR 1.831 – 1.834, 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 identify errors in any “Sequence Listing XML” that might not have been identified by pre-examination staff. The examiner can identify the requirements on a “OPAP Routing Sheet” (Document Code “SEQREQ”) and return the application to pre-examination status for the mailing of a notice indicating the deficiencies.

Applicant response to a notice or an Office action requiring a replacement “Sequence Listing XML” would involve submitting the following:

  • (1) A compliant replacement “Sequence Listing XML” submitted as an XML file containing the entire “Sequence Listing XML,” including any additions, deletions, or replacements of sequence information, 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(b)(1));
  • (2) An amendment to the specification to incorporate by reference the material in the XML file containing the replacement “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(b)(1) and 37 CFR 1.835(c));
  • (3) A statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced “Sequence Listing XML” (37 CFR 1.835(b)(3));
  • (4) A statement identifying the basis for the additions, deletions, or replacements of the sequence information in the application as originally filed for all amended sequence data in the replacement “Sequence Listing XML,” which would include, e.g., pages of specification where a sequence is disclosed or drawing sheets identifying the sequence which is part of the replacement “Sequence Listing XML” (37 CFR 1.835(b)(4)); and
  • (5) A statement that no new matter is introduced by the content of the XML file containing the replacement “Sequence Listing XML” (37 CFR 1.835(b)(5)).

If applicant recognizes a deficiency in a previously submitted “Sequence Listing XML” or otherwise chooses to amend a previously submitted “Sequence Listing XML,” a replacement “Sequence Listing XML” must be filed including all of the above described items.