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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules
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1.832 Representation of nucleotide and/
or amino acid sequence data in the Sequence Listing XML part of a patent application filed on or after January 1, 2022.

a Each disclosed nucleotide or amino acid sequence that meets the requirements of 1.831b must appear separately in the Sequence Listing XML. Each sequence set forth in the Sequence Listing XML must be assigned a separate sequence identifier.
The sequence identifiers must begin with 1 and increase sequentially by integers as defined in WIPO Standard ST.26 2020 incorporated by reference, see 1.839, paragraph 10.
b The representation and symbols for nucleotide sequence data shall conform to the requirements of paragraphs b1 through 4 of this section.
1 A nucleotide sequence must be represented in the manner described in WIPO Standard ST.26 2020, paragraphs 1112.
2 All nucleotides, including nucleotide analogs, modified nucleotides, and unknown nucleotides, within a nucleotide sequence must be represented using the symbols set forth in WIPO Standard ST.26 2020, paragraphs 1316, 19 and 21.
3 Modified nucleotides within a nucleotide sequence must be described in the manner discussed in WIPO
Standard ST.26 2020, paragraphs 17
18, and 19.
4 A region containing a known number of contiguous a, c, g, t, or n residues for which the same description applies may be jointly described in the manner described in WIPO Standard ST.26 2020, paragraph 22.
c The representation and symbols for amino acid sequence data shall conform to the requirements of paragraphs c1 through 4 of this section.
1 The amino acids in an amino acid sequence must be represented in the manner described in WIPO Standard ST.26 2020, paragraphs 2425.
2 All amino acids, including modified amino acids and unknown amino acids, within an amino acid sequence must be represented using the symbols set forth in WIPO Standard ST.26 2020, paragraphs 2629 and 32.
3 Modified amino acid within an amino acid sequence must be described in the manner discussed in WIPO
Standard ST.26 2020, paragraphs 29
and 30.
4 A region containing a known number of contiguous X residues for which the same description applies may be jointly described in the manner
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described in WIPO Standard ST.26
2020, paragraph 34.
d A nucleotide and/or amino acid sequence that is constructed as a single continuous sequence derived from one or more non-contiguous segments of a larger sequence or from segments of different sequences must be listed in a sequence listing in the manner described in WIPO Standard ST.26
2020, paragraph 35.
e A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more regions of contiguous n or X residues, wherein the exact number of n or X residues in each region is disclosed, must be listed in a sequence listing in the manner described in WIPO Standard ST.26
2020, paragraph 36.
f A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more gaps of an unknown or undisclosed number of residues must be listed in a sequence listing in the manner described in WIPO Standard ST.26 2020, paragraph 37.
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 January 1, 2022.

a The Sequence Listing XML as required by 1.831a must be presented as a single file in XML 1.0 encoded using Unicode UTF8 where the character set complies with WIPO
Standard ST.26 2020 incorporated by reference, see 1.839, paragraphs 40
and 41 and Annex IV thereof.
b The Sequence Listing XML as required by 1.833a must:
1 Be valid according to the Document Type Definition DTD as presented in Annex II of WIPO Standard ST.26 2020.
2 Comply with the requirements of WIPO Standard ST.26 2020 to include:
i An XML declaration as defined in WIPO Standard ST.26 2020, paragraph 39;
ii A document type DOCTYPE
declaration as defined in WIPO
Standard ST.26 2020, paragraph 39;
iii A root element as defined in WIPO Standard ST.26 2020, paragraph 43;
iv A general information part that complies with the requirements of WIPO Standard ST.26 2020, paragraphs 45, 47 and 48, as applicable;
and v A sequence data part that complies with the requirements of WIPO
Standard ST.26 2020, paragraphs 50
55, 5758, 6069, 7178, 8087, 8998
and 100, as applicable.

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3 Include one InventionTitle element in the English language, in the format required by WIPO Standard ST.26 2020, paragraphs 45 and 48, and as required by 1.52b1ii.
4 Include an INSDQualifier_value element with a value in the English language for any language-dependent free text qualifier as defined by WIPO
Standard ST.26 2020, paragraphs 76
and 8588, and as required by 1.52b1ii.
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 January 1, 2022.

a A Sequence Listing XML
encoded using Unicode UTF8, created by any means e.g., text editors, nucleotide/amino acid sequence editors, or other custom computer programs in accordance with 1.831 through 1.833, must:
1 Have the following compatibilities:
i Computer compatibility: PC or Mac; and ii Operating system compatibility:
MSDOS, MS-Windows, Mac OS, or Unix/Linux.
2 Be in XML format, where all permitted printable characters including the space character and nonprintable control characters are defined in WIPO Standard ST.26 2020
incorporated by reference, see 1.839, paragraph 40.
3 Be named as .xml, where is one character or a combination of characters limited to upperor lowercase letters, numbers, hyphens, and underscores and the name does not exceed 60 characters in total, excluding the extension. No spaces or other types of characters are permitted in the file name.
b The Sequence Listing XML must be in a single file containing the sequence information and be submitted either:
1 Electronically via the USPTO
patent electronic filing system, where the file size must not exceed 100 MB, and file compression is not permitted;
or 2 On read-only optical discs in compliance with 1.52e, where:
i A file that is not compressed must be contained on a single read-only optical disc;
ii The file may be compressed using WinZip, 7-Zip, or Unix/Linux Zip;
iii A compressed file must not be self-extracting; and iv A compressed XML file that does not fit on a single read-only optical disc may be split into multiple file parts, in accordance with the target read-only
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