[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 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. (e) If any of the requirements of §§ 1.831 through 1.834 are not satisfied at the time of filing an international application under the PCT, where the application is to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority, the applicant may be sent a notice necessitating compliance with the requirements within a prescribed time period. Under PCT Rule 13ter, the applicant can provide, in response to such a requirement or otherwise, a sequence listing that is a "Sequence Listing XML" in accordance with § 1.831(a). The "Sequence Listing XML" must be accompanied by a statement that the information recorded does not go beyond the disclosure in the international application as filed. In response to such a requirement, the late furnishing fee set forth in § 1.445(a)(5) is also required. If the applicant fails to timely provide the required "Sequence Listing XML," the United States International Searching Authority shall search only to the extent that a meaningful search can be performed without the "Sequence Listing XML," and the United States International Preliminary Examining Authority shall examine only to the extent that a meaningful examination can be performed without the "Sequence Listing XML."

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Where an international application, filed under the PCT, contains a disclosure of nucleotide and/or amino acid sequences, the description shall include a sequence listing part of the description complying with the standard provided for in Annex C of the Administrative Instruction. However, where applicant has not provided a sequence listing in accordance with Annex C of the Administrative Instructions and the USPTO acts as International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA) for, the ISA/IPEA may invite applicant to furnish a sequence listing, with a late furnishing fee, under PCT Rule 13ter . This invitation will specify a time limit for a proper response. A proper response to such an invitation would include, the submission of a "Sequence Listing XML" accordance with Annex C of the Administrative Instructions, the late furnishing fee in 37 CFR 1.445(a)(5), and a statement that the information recorded does not go beyond the disclosure in the international application as filed. If a compliant "Sequence Listing XML" has not been furnished to the ISA/IPEA within the time limit set forth in the invitation, the ISA/IPEA will only search and examine the international application to the extent that a meaningful search or examination can be performed without the "Sequence Listing XML."

See MPEP §§ 1823.02 and 1848.