Federal Register - July 6, 2021

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Source: Federal Register

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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules Standard ST.26 2020. For a region containing a known number of contiguous a, c, g, t, or n residues for which the same description applies, the entire region may be jointly described as provided in Paragraph 22
of WIPO Standard ST.26 2020.
Section 1.832c1 through 4 are proposed to be added to define the requirements for representation of amino acid sequence data in the Sequence Listing XML. Specifically, an amino acid sequence must be represented in the manner described in Paragraphs 2425 of WIPO Standard ST.26 2020. All amino acids, including modified amino acids and unknown amino acids, in an amino acid sequence must be represented and described using symbols in the manner described in Paragraphs 2430 and 32 of WIPO
Standard ST.26 2020. For a region containing a known number of contiguous X residues for which the same description applies, the entire region may be jointly described as provided in Paragraph 34 of WIPO
Standard ST.26 2020.
Section 1.832d is proposed to be added to define the manner in which a single continuous sequence, derived from one or more non-contiguous segments of a larger sequence, or from segments of different sequences, must be represented, as described in Paragraph 35 of WIPO Standard ST.26
2020.
Section 1.832e is proposed to be added to define the manner in which 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 of specified length must be represented, as described in Paragraph 36 of WIPO Standard ST.26 2020.
Section 1.832f is proposed to be added to define the manner in which 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 represented, as described in Paragraph 37 of WIPO Standard ST.26 2020.
Section 1.833: Section 1.833 is proposed to be added to describe the requirements for a Sequence Listing XML, which is required by 1.831a for patent applications with a filing date on or after January 1, 2022, in order to comply with WIPO Standard ST.26
2020.
Section 1.833a is proposed to be added to require that the Sequence Listing XML must be presented as a single XML 1.0 file and encoded using Unicode UTF8.

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Section 1.833b1 is proposed to be added to require that the Sequence Listing XML must be valid according to the DTD as presented in Annex II of WIPO Standard ST.26 2020.
Section 1.833b2 is proposed to be added to require that a Sequence Listing XML must comply with the list of items enumerated in iv which are found in WIPO Standard ST.26 2020.
Section 1.833b2i is proposed to be added to require that the Sequence Listing XML contain an XML
declaration as defined in WIPO
Standard ST.26 2020, Paragraph 39.
Section 1.833b2ii is proposed to be added to require that the Sequence Listing XML contain a document type declaration as defined in WIPO
Standard ST.26 2020, Paragraph 39.
Section 1.833b2iii is proposed to be added to require that the Sequence Listing XML contain a root element as defined in WIPO Standard ST.26 2020, Paragraph 43.
Section 1.833b2iv is proposed to be added to require that the Sequence Listing XML contain a general information part that complies with WIPO Standard ST.26 2020, Paragraphs 45, 47 and 48, as applicable.
Section 1.833b2v is proposed to be added to require that the Sequence Listing XML contain a sequence data part that complies with WIPO Standard ST.26 2020, Paragraphs 5055, 5758, 6069, 7178, 8087, 8998 and 100, as applicable.
Section 1.833b3 is proposed to be added to require that the Sequence Listing XML contains at least one InventionTitle element, as set forth in WIPO Standard ST.26 at Paragraphs 45
and 48, in the English language since English is required under 1.52b1ii.
Section 1.833b4 is proposed to be added to require that an INSDQualifier_
value element includes a value for that element in the English language for each language-dependent free text qualifier in the Sequence Listing XML, as required by 1.52b1ii, and where an INSDQualifier_value element is defined in WIPO Standard ST.26 2020, Paragraphs 76 and 8588.
Section 1.834: Section 1.834 is proposed to be added to provide details on the 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.
Section 1.834a is proposed to be added to indicate that a Sequence Listing XML in 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

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must: 1 Have the following compatibilities: i Computer compatibility: PC or Mac; and ii operating system compatibility e.g., 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 Paragraph 40 of WIPO
Standard ST.26 2020; and 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.
Section 1.834b is proposed to be added to require that 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, 7Zip, or Unix/Linux Zip, iii a compressed file must not be selfextracting, and iv a compressed XML
file that does not fit on a single readonly optical disc may be split into multiple file parts in accordance with the target read-only optical disc size and labeled in compliance with 1.52e5vi.
Section 1.835: Section 1.835 is proposed to be added to provide the requirements for submission of an amendment to add or replace a Sequence Listing XML for applications filed on or after January 1, 2022.
Section 1.835a is proposed to be added to require that any amendment to a patent application adding an initial submission of a Sequence Listing XML as required by 1.831a after the application filing date must include: 1
A Sequence Listing XML file submitted either i via the USPTO
patent electronic filing system or ii on a read-only optical disc in compliance with 1.52e; 2 an instruction to amend the specification to include an incorporation by reference statement of the material in the Sequence Listing XML file, identifying the name of the file, the date of creation, and the size of the file in bytes see 1.77b5ii, except when submitted to the United States International Preliminary Examining Authority for an
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Federal Register - July 6, 2021

TitreFederal Register

PaysÉtats-Unis

Date06/07/2021

Page count220

Edition count7798

Première édition14/03/1936

Dernière édition18/06/2026

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