[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. 1.835 Amendment to add or replace a "Sequence Listing XML" in patent applications filed on or after July 1, 2022.

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2. 1. (d)(1) If any of the requirements of §§ 1.831 through 1.834 are not satisfied in an application under 35 U.S.C. 111(a) or in a national stage application under 35 U.S.C. 371, the applicant will be notified and given a period of time within which to comply with such requirements in order to prevent abandonment of the application. Subject to paragraph (d)(2) of this section, any amendment to add or replace a "Sequence Listing XML" or add an incorporation by reference of the material contained in the "Sequence Listing XML" in response to a requirement under this paragraph (d)(1) must be submitted in accordance with the requirements of paragraphs (a) through (c) of this section.

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Initial review by the pre-examination staff at the USPTO checks for compliance with formal matters. In order to ensure that an application is ready for examination, pre-examination staff check that applications containing disclosures of nucleotides and/or amino acid sequences have complied with the sequence listing rules. This means that for applications having a filing date on or after July 1, 2022, containing such sequence disclosures, a "Sequence Listing XML" must be of record and if not, applicant will be notified of such deficiency and provided instructions for responding. Adding a "Sequence Listing XML" where one was not previously filed must conform with the requirements of 37 CFR 1.835(a). See MPEP § 2414.02 for details. To amend a "Sequence Listing XML" due to errors or omissions, the procedure is outlined in 37 CFR 1.835(b). See MPEP § 2414.03 for details.