[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.

1. *****

2. 1. (c)(1) Unless paragraph (c)(2) of this section applies, when the "Sequence Listing XML" required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e) ), then the specification must contain a statement in a separate paragraph (see § 1.77(b)(5) ) that incorporates by reference the material in the XML file identifying:
      1. (i) The name of the file;
      2. (ii) The date of creation; and
      3. (iii) The size of the file in bytes; or
   2. (2) If the "Sequence Listing XML" required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e) ) for an international application during the international stage, then an incorporation by reference statement of the material in the XML file is not required.

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.

1. *****

2. (c) The specification of a complete application, filed on the application filing date, with a "Sequence Listing XML" as required under § 1.831(a), without an incorporation by reference of the material contained in the "Sequence Listing XML" file, must be amended to include a separate paragraph incorporating by reference the material contained in the "Sequence Listing XML" file, in accordance with § 1.77(b)(5)(ii), except for international applications.

3. *****

Since the "Sequence Listing XML" is not the text of the specification, but rather is sequence data in an XML file format, an incorporation by reference statement is needed to ensure that the content of the "Sequence Listing XML," submitted to the USPTO as an XML file, is considered part of the disclosure capable of providing 35 U.S.C. 112(a) support for the disclosure and any claims relating to nucleotide and/or amino acid sequences. The incorporation by reference statement identifies: (i) the name of the file; (ii) the date of creation of the file; and (iii) the size of the file in bytes Note that this requirement pertaining to applicant submission of a "Sequence Listing XML" does not apply to a sequence listing that is part of an international application and communicated to the USPTO under PCT Article 20, for a national phase application.

The incorporation by reference statement of the material in an .xml file is required to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on an .xml file. However, for international applications during the international phase, where a "Sequence Listing XML" is submitted via the USPTO patent electronic filing system or on read-only optical disc, no such incorporation by reference statement is required.

If an applicant submits a "Sequence Listing XML" with the complete specification but fails to include the required incorporation by reference paragraph, a notice can be issued by pre-examination requiring the incorporation by reference paragraph in the context of a substitute specification under 37 CFR 1.125. Similarly, the examiner could require applicant to amend the specification to include an incorporation by reference paragraph of the "Sequence Listing XML" file. See also form paragraph 24.24.26.