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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules
proposed amendment indicates that a Sequence Listing need not be translated for national stage entry if the Sequence Listing complies with PCT
Rule 12.1d and the description complies with PCT Rule 5.2b for applications having an international filing date before January 1, 2022.
However, the proposed amendment indicates that a Sequence Listing in XML format must be translated for national stage entry if a Sequence Listing in XML format was submitted in an international application with non-English language values for the invention title and/or any languagedependent free text qualifiers and has an international filing date on or after January 1, 2022.
Section 1.530: The heading of 1.530d1 was proposed to be amended in another rulemaking that published at 86 FR 28301 May 26, 2021. This proposed rule would further amend that heading to include Sequence Listing XML 1.831a.
Section 1.530d1i was proposed to be added in another rulemaking that published at 86 FR 28301 May 26, 2021. This proposed rule would further amend that paragraph to add an exception to reexamination amendment practice for a Sequence Listing XML
1.831a.
Section 1.530d1ii was proposed to be added in another rulemaking that published at 86 FR 28301 May 26, 2021. This proposed rule would further amend that paragraph to provide that changes to a Sequence Listing XML
must be made in accordance with 1.835.
Section 1.704: Section 1.704f is proposed to be amended to add a Sequence Listing XML in compliance with 1.831 through 1.835 if applicable to the list of items that are required for an application filed under 35 U.S.C. 111a to be in condition for examination for purposes of calculating a reduction in patent term adjustment.
The amendment also proposes to add a Sequence Listing XML in compliance with 1.831 through 1.835 if applicable to the list of items that must be submitted in an international application for such an application to be in condition for examination when the application has entered the national stage as defined in 1.491b. Lastly, the rule is also proposed to be amended to add a Sequence Listing XML in compliance with 1.831 through 1.835
if applicable to the current list of items for which an application is considered to be in compliance, for purposes of determining a patent term adjustment reduction, on the filing date of the latest reply if any correcting the papers,
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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.
Section 1.831: Section 1.831 is proposed to be added to require that patent applications having disclosures of nucleotide and amino acid sequences, as those terms are defined in the rule, must contain, as a separate part of the disclosure, a Sequence Listing XML
for patent applications having a filing date on or after January 1, 2022.
Section 1.831a is proposed to be added to specify that the Sequence Listing XML uses the symbols and format in accordance with the requirements of 1.832 through 1.834.
Section 1.831b1 and 2 are proposed to be added to define the nucleotide and amino acid sequences that are encompassed by the rule for which a Sequence Listing XML is needed. Specifically, nucleotide and/or amino acid sequences as used in these proposed rules encompass: An unbranched sequence or linear region of a branched sequence containing four or more specifically defined amino acids, wherein the amino acids form a single peptide backbone or an unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by: A 3 to 5 or 5 to 3 phosphodiester linkage or, for nucleotide analogs, any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids.
Section 1.831c is proposed to be added to state that, 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. The use of SEQ ID NO: Is preferred but including or the like is intended to ensure that a formalities notice is not sent when an application uses, for example, SEQ NO. or Seq. Id. No.
or any similar identification of an amino acid or nucleotide sequence in the specification or claims where it is clear that a sequence from the Sequence Listing XML is shown in the specification or claims. In identifying the sequence in the description or claims, the numeric sequence identifier
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from the Sequence Listing XML must be identifying the same sequence.
Section 1.831d is proposed to be added to define the expression enumeration of its residues, consistent with the definition in Paragraph 3c of WIPO Standard ST.26
itself which is incorporated by reference herein.
Section 1.831e is proposed to be added to define the expression specifically defined, consistent with the definition in Paragraph 3m of WIPO Standard ST.26 2020.
Section 1.831f is proposed to be added to define the expression amino acid, consistent with the definition in Paragraph 3a of WIPO Standard ST.26
2020.
Section 1.831g is proposed to be added to define the expression modified amino acid, consistent with the definition in Paragraph 3g of WIPO
Standard ST.26 2020.
Section 1.831h is proposed to be added to define the expression nucleotide, consistent with Paragraphs 3h and 3i of WIPO
Standard ST.26 2020.
Section 1.831i is proposed to be added to define the expression modified nucleotide, consistent with Paragraph 3h of WIPO Standard ST.26
2020.
Section 1.832: Section 1.832 is proposed to be added to provide the manner in which a nucleotide and/or amino acid sequence is presented in the Sequence Listing XML part of a patent application having a filing date on or after January 1, 2022.
Section 1.832a is proposed to be added to define the requirements for representation of sequences in a Sequence Listing XML part of the application. Specifically, each nucleotide and/or amino acid sequence presented in the Sequence Listing XML must be assigned a separate sequence identifier, and the sequence identifiers must begin with the number 1, and increase sequentially by integers as defined in Paragraph 10 of WIPO
Standard ST.26 2020.
Section 1.832b1 through 4 are proposed to be added to define the requirements for representation of nucleotide sequence data in the Sequence Listing XML. Specifically, a nucleotide sequence must be represented in the manner described in Paragraphs 1112 of WIPO Standard ST.26 2020. All nucleotides, including nucleotide analogs, modified nucleotides, unknown nucleotides in a nucleotide sequence must be represented and described using symbols in the manner described in Paragraphs 1319 and 21 of WIPO

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