[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. (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, PCT Rule 5.2 requires that the description shall include a sequence listing part of the description complying with the standard provided for in the Administrative Instructions (AI). In accordance with Section 208, any sequence listing, whether forming part of the international application or not forming part of the international application, shall comply with Annex C of the AI. Where applicant has not provided a sequence listing in accordance with Annex C of the AI and the USPTO acts as International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), 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 accordance with Annex C of the AI, the late furnishing fee specified in 37 CFR 1.445(a)(5), and a statement to the effect that the sequence listing does not go beyond the disclosure of the international application as filed. If a sequence listing compliant with WIPO Standard ST.26 has not been furnished to the ISA/IPEA within the time limit set forth in the invitation, the ISA/IPEA will only search/examine the international application to the extent that a meaningful search or examination can be performed without the sequence listing.

See MPEP §§ 1823.02 and 1848.