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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules
Computer Program Listing Appendix 1.96c, a Sequence Listing 1.821c or a Sequence Listing XML
1.831a. i Changes to the specification, other than to the claims, Large Tables 1.58c, a Computer Program Listing Appendix 1.96c, a Sequence Listing 1.821c, or a Sequence Listing XML 1.831a, must be made by submission of the entire text of an added or rewritten paragraph, including markings pursuant to paragraph f of this section, except that an entire paragraph may be deleted by a statement deleting the paragraph, without presentation of the text of the paragraph. The precise point in the specification where any added or rewritten paragraph is located must be identified.
ii Changes to Large Tables, a Computer Program Listing Appendix, a Sequence Listing, or a Sequence Listing XML must be made, in accordance with 1.58g for Large Tables, 1.96c5 for a Computer Program Listing Appendix, 1.825 for a Sequence Listing, and 1.835 for a Sequence Listing XML.

10. Section 1.704 is amended by revising paragraph f to read as follows:
1.704 Reduction of period of adjustment of patent term.

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f An application filed under 35
U.S.C. 111a is in condition for examination when the application includes a specification, including at least one claim and an abstract 1.72b, and has papers in compliance with 1.52, drawings if any in compliance with 1.84, any English translation required by 1.52d or 1.57a, a sequence listing in compliance with 1.821 through 1.825
if applicable, a Sequence Listing XML in compliance with 1.831
through 1.835 if applicable, an inventors oath or declaration or an application data sheet containing the information specified in 1.63b, the basic filing fee 1.16a or c, the search fee 1.16k or m, the examination fee 1.16o or q, any certified copy of the previously filed application required by 1.57a, and any application size fee required by the Office under 1.16s. An international application is in condition for examination when the application has entered the national stage as defined in 1.491b, and includes a specification, including at least one claim and an abstract 1.72b, and has papers in compliance with 1.52, drawings if any in compliance with 1.84, a sequence listing in compliance with
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1.821 through 1.825 if applicable, a Sequence Listing XML in compliance with 1.831 through 1.835 if applicable, the inventors oath or declaration or an application data sheet containing the information specified in 1.63b, the search fee 1.492b, the examination fee 1.492c, and any application size fee required by the Office under 1.492j. An application shall be considered as having papers in compliance with 1.52, drawings if any in compliance with 1.84, and a sequence listing in compliance with 1.821 through 1.825 if applicable or a Sequence Listing XML in compliance with 1.831 through 1.835
if applicable, for purposes of this paragraph f on the filing date of the latest reply if any correcting the papers, drawings, or sequence listing that is prior to the date of mailing of either an action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C.
151, whichever occurs first.
11. Sections 1.831 through 1.835 and 1.839 are added to read as follows:
Sec.
1.831 Requirements for patent applications filed on or after January 1, 2022, having nucleotide and/or amino acid sequence disclosures.
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.
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.
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.
1.835 Amendment to add or replace a Sequence Listing XML in patent applications filed on or after January 1, 2022.
1.839 Incorporation by reference.

1.831 Requirements for patent applications filed on or after January 1, 2022, having nucleotide and/or amino acid sequence disclosures.

a Patent applications disclosing nucleotide and/or amino acid sequences by enumeration of their residues, as defined in paragraph b of this section, must contain, as a separate part of the disclosure, a computer readable Sequence Listing in XML eXtensible Markup Language format a Sequence Listing XML. Disclosed nucleotide or amino acid sequences that do not meet the definition of paragraph b of this section must not be included in the Sequence Listing XML. The Sequence Listing XML contains the
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sequence information of the nucleotides and/or amino acids disclosed in the patent application using the symbols and format in accordance with the requirements of 1.832 through 1.834.
b Nucleotide and/or amino acid sequences as used in 1.831 through 1.835, encompass:
1 An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone; or 2 An unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by:
i A 3 to 5 or 5 to 3
phosphodiester linkage; or ii Any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids, i.e., nucleotide analogs.
c Where the description or claims of a patent application discuss a sequence that is set forth in the Sequence Listing XML in accordance with paragraph a of this section, reference must be made to the sequence by use of the sequence identifier, preceded by SEQ ID NO: Or the like in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
d Enumeration of its residues means disclosure of a nucleotide or amino acid sequence in a patent application by listing, in order, each residue of the sequence, where the residues are represented in the manner as defined in WIPO Standard ST.26
2020 incorporated by reference, see 1.839, paragraph 3ci or ii.
e Specifically defined means any amino acid or nucleotide as defined in WIPO Standard ST.26 2020, paragraph 3m.
f Amino acid includes any Dor L-amino acid or modified amino acid as defined in WIPO Standard ST.26 2020, paragraph 3a.
g Modified amino acid includes any amino acid as described in WIPO
Standard ST.26 2020, paragraph 3g.
h Nucleotide includes any nucleotide, nucleotide analog or modified nucleotide as defined in WIPO
Standard ST.26 2020, paragraphs 3h and 3i.
i Modified nucleotide includes any nucleotide as described in WIPO
Standard ST.26 2020, paragraph 3h.

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