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This document serves as a formal response to the USPTO's request for comments regarding the proposed ST.26 standard for disclosing sequence listings using XML. It includes general comments, rule-specific
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How to fill out Request for Comments on the Recommendation for the Disclosure of Sequence Listings Using XML (Proposed ST.26)

01
Obtain the Request for Comments (RFC) document related to Proposed ST.26.
02
Review the guidelines and requirements specified in the RFC.
03
Prepare your comments or feedback on the proposed recommendations.
04
Ensure your comments are clear and concise, addressing specific sections of the proposal.
05
Fill out the required personal or organizational information as requested in the RFC.
06
Submit your comments by the specified deadline, following the submission instructions outlined in the RFC.

Who needs Request for Comments on the Recommendation for the Disclosure of Sequence Listings Using XML (Proposed ST.26)?

01
Researchers and scientists working with sequence listings.
02
Companies and organizations involved in biotechnology and pharmaceuticals.
03
Intellectual property professionals who handle patent applications related to biological sequences.
04
Regulatory bodies and governmental agencies interested in standardizing sequence listings.
05
Software developers creating tools for managing sequence data.
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STANDARD ST.26 This Standard defines the nucleotide and amino acid sequence disclosures in a patent application required to be included in a sequence listing, the manner in which those disclosures are to be represented, and the Document Type Definition (DTD) for a sequence listing in XML (eXtensible Markup Language).
For PCT applications filed on or after July 1, 2022, sequence listings must comply with WIPO Standard ST. 26. The key requirements are: Sequence listings must be in a standardized electronic eXtensible Markup Language (XML) format, referred to as “Sequence Listing XML”.
The sequence rules embrace all unbranched nucleotide sequences with ten or more nucleotide bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 10 “specifically defined” nucleotides or 4 “specifically defined” nucleotides or amino acids.
The incorporation-by-reference paragraph is a crucial element when submitting a Sequence Listing as an ASCII text file. ing to MPEP 2427, this paragraph must be inserted into the specification and should include: The name of the ASCII text file. The date of creation of the file.
What is a sequence listing? A sequence listing provides a standardized means of presenting the entirety of biological sequence data that is disclosed in a patent application in a single document.
25 does not require inclusion of D-amino acids, linear portions of branched sequences, or nucleotide analogs, while ST. 26 does. ST. 25 does permit inclusion of sequences with less than 10 nucleotides and less than 4 amino acids, while such sequences are prohibited in ST.
A sequence listing, as a separate part of the disclosure: Contains nucleotide and/or amino acid sequences disclosed in a patent application. Includes descriptive information about each sequence. Conforms to the requirements of the relevant WIPO Standard.

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The Request for Comments on the Recommendation for the Disclosure of Sequence Listings Using XML (Proposed ST.26) is a proposal that invites feedback from stakeholders regarding a standardized method for submitting biological sequence listings in an XML format to enhance compatibility and accessibility in intellectual property applications.
Entities and individuals who prepare and file patent applications containing biological sequences, including patent attorneys, researchers, and organizations in the biotechnology and biopharmaceutical industries, are encouraged to file their comments.
To fill out the Request for Comments, participants should provide their feedback on the proposed XML recommendations by following the guidelines set by the issuing authority, ensuring clarity and presenting specific points of support or objection regarding the proposed disclosure methods.
The purpose of the Request for Comments is to gather insights and perspectives from relevant stakeholders to refine and finalize the XML formatting standards for biological sequence listings, ensuring they meet the needs of the filing community and improve the patent process.
Respondents are required to report their opinions, suggestions, and concerns regarding the proposed XML framework, including any potential challenges or benefits they foresee in adopting the new sequence listing format.
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