[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

37 C.F.R. 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.

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2. (b) The "Sequence Listing XML" must be in a single file containing the sequence information and be submitted either:
   1. (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. (2) On read-only optical disc(s) in compliance with § 1.52(e), where:
      1. (i) A file that is not compressed must be contained on a single read-only optical disc;
      2. (ii) The file may be compressed using WinZip^®, 7-Zip, or Unix^®/Linux^® Zip;
      3. (iii) A compressed file must not be self-extracting; or
      4. (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);

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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 filing system. Only the Patent Center system of the USPTO patent electronic filing 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.

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 a 35 U.S.C. 111(a) application having a filing date on or after July 1, 2022, will result in a notice from the Office of Patent Application Processing (OPAP) 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 1.821 -1.824 where a "Sequence Listing XML" that complies with 37 CFR 1.831 -1.834 is required in a national nonprovisional application.

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 enclosed in a hard case should be placed in a protective mailer. The use of staples and clips, if any, should be confined to carefully attaching the protective mailer to the submitted papers without contact or compression of the media. The labeling requirements of 37 CFR 1.52(e) and including the application number (if known), apply to all read-only optical disc submissions. For submission of a "Sequence Listing XML" larger than 100MB in size in a new application, it is recommended that the user file the application without the "Sequence Listing XML" using the USPTO patent electronic filing system to obtain the application number, and then file the "Sequence Listing XML" on read-only optical disc(s) in accordance with 37 CFR 1.52(e) on the same day by using Priority Mail Express® from the USPS in accordance with 37 CFR 1.10, or hand delivery, in order to secure the same filing date for all parts of the application. In no situations should additional or complimentary electronic copies be delivered to examiners or other Office personnel.