2413.03 How to Submit the “Sequence Listing XML” [R-07.2022]

2413.03 How to Submit the “Sequence Listing XML” [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 1.834 Form and format for nucleotide and/ or amino acid sequence submissions as the “Sequence Listing XML” in patent applications filed on or after July 1, 2022.

  • *****

  • (b) The “Sequence Listing XML” must be in a single file containing the sequence information and be submitted either:
    • (1) Electronically via the USPTO patent electronic filing system, where the file size must not exceed 100 MB, and file compression is not permitted; or
    • (2) On read-only optical disc(s) in compliance with § 1.52(e), where:
      • (i) A file that is not compressed must be contained on a single read-only optical disc;
      • (ii) The file may be compressed using WinZip®, 7-Zip, or Unix®/Linux® Zip;
      • (iii) A compressed file must not be self-extracting; or
      • (iv) A compressed XML file that does not fit on a single read-only optical disc may be split into multiple file parts, in accordance with the target read-only optical disc size, and labeled in compliance with § 1.52(e)(5)(vi);
  • *****

For submission of a “Sequence Listing XML” that is 100MB in size or less, the preferred method of submission is via the USPTO Patent Electronic System. Only the Patent Center system of the USPTO Patent Electronic System is capable of accepting .xml files. If the “Sequence Listing XML” is larger than 100MB in size, then applicant may submit the .xml file on physical media using read-only optical discs (CDs or DVDs). “Sequence Listing XML” submissions on discs may be compressed if the resulting compressed file is non-self-extracting.

For applications filed on or after July 1, 2022, the USPTO patent electronic filing system will prohibit an applicant from submitting both a “Sequence Listing XML” (a sequence listing that conforms to WIPO Standard ST.26 as implemented in 37 CFR 1.831 through 1.835) and a “Sequence Listing” (a sequence listing that conforms to ST.25 as implemented in 37 CFR 1.821 through 1.825) in the same submission. Filing a “Sequence Listing” in an application filed on or after July 1, 2022, will result in a notice informing applicant that the submission fails to comply with 37 CFR 1.831 through 1.834 and will require submission of a “Sequence Listing XML.” See MPEP § 2415.03 for addressing improper submission of a “Sequence Listing” that complies with 37 CFR 1.8211.824 where a “Sequence Listing XML” that complies with 37 CFR 1.8311.834 is required.

To facilitate administrative processing of all papers and read-only optical discs associated with sequence rule compliance, all read-only optical discs, fees, and papers accompanying them filed in the Office should be marked “Mail Stop SEQUENCE.” Correspondence relating to the submission of a “Sequence Listing XML” may also be hand-delivered to the Customer Service Window. In cases of hand delivery to the Customer Service Window, the read-only optical disc should be placed in a protective mailer labeled with at least the application number, if available. The labeling requirements of 37 CFR 1.52(e) and 1.834(b)(2) apply. The use of staples and clips, if any, should be confined to carefully attaching the mailer to the submitted papers without contact or compression of the media. In no situations should additional or complimentary electronic copies be delivered to examiners or other Office personnel.