Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 37 - Patents, Trademarks, and Copyrights |
Chapter I - United States Patent and Trademark Office, Department of Commerce |
SubChapter A - General |
Part 1 - Rules of Practice in Patent Cases |
Subpart G - Biotechnology Invention Disclosures |
Application Disclosures Containing Nucleotide and/or Amino Acid Sequences |
§ 1.833 - xxx
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§ 1.833 Requirements for a “Sequence Listing XML” for nucleotide and/or amino acid sequences as part of a patent application filed on or after July 1, 2022.
(a) The “Sequence Listing XML” as required by § 1.831(a) must be presented as a single file in XML 1.0 encoded using Unicode UTF-8, where the character set complies with paragraphs 40 and 41 and Annex IV of WIPO Standard ST.26 (incorporated by reference, see § 1.839).
(b) The “Sequence Listing XML” presented in accordance with paragraph (a) of this section must further:
(1) Be valid according to the Document Type Definition (DTD) as presented in WIPO Standard ST.26, Annex II.
(2) Comply with the requirements of WIPO Standard ST.26 to include:
(i) An XML declaration as defined in paragraph 39(a) of WIPO Standard ST.26;
(ii) A document type (DOCTYPE) declaration as defined in paragraph 39(b) of WIPO Standard ST.26;
(iii) A root element as defined in paragraph 43 of WIPO Standard ST.26;
(iv) A general information part that complies with the requirements of paragraphs 45, 47, and 48, as applicable, of WIPO Standard ST.26; and
(v) A sequence data part that complies with the requirements of paragraphs 50-55, 57, 58, 60-69, 71-78, 80-87, 89-98, and 100, as applicable, of WIPO Standard ST.26 representing the nucleotide and/or amino acid sequences according to § 1.832.
(3) Include an INSDQualifier__value element with a value in English for any language-dependent free text qualifier as defined by paragraphs 76 and 85-87 of WIPO Standard ST.26, and as required by § 1.52(b)(1)(ii).
[87 FR 30818, May 20, 2022]