{"abstract":"The United States Patent and Trademark Office (USPTO or Office) is proposing to revise the rules of practice for submitting biological sequence data associated with disclosures of nucleotide and amino acid sequences in patent applications by incorporating by reference the provisions of Standard ST.26 into the USPTO rules. Other conforming changes to accommodate for proposed new rules of practice based on the new standard are also included. These proposed amendments would apply to international and national applications filed on or after January 1, 2022. In addition to simplifying the process for applicants filing in multiple countries, a requirement to submit a single sequence listing in eXtensible Mark-up Language (XML) format will result in better preservation, accessibility, and sorting of the submitted sequence data for the public.","action":"Notice of proposed rulemaking.","agencies":[{"raw_name":"DEPARTMENT OF COMMERCE","name":"Commerce Department","id":54,"url":"https://www.federalregister.gov/agencies/commerce-department","json_url":"https://www.federalregister.gov/api/v1/agencies/54","parent_id":null,"slug":"commerce-department"},{"raw_name":"Patent and Trademark Office","name":"Patent and Trademark Office","id":402,"url":"https://www.federalregister.gov/agencies/patent-and-trademark-office","json_url":"https://www.federalregister.gov/api/v1/agencies/402","parent_id":54,"slug":"patent-and-trademark-office"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/07/06/2021-14325.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1","title":37}],"citation":"86 FR 35429","comment_url":null,"comments_close_on":"2021-09-07","correction_of":null,"corrections":[],"dates":"Comments must be received by September 7, 2021 to ensure consideration.","disposition_notes":null,"docket_ids":["Docket No. PTO-P-2021-0006"],"dockets":[{"supporting_documents":[{"title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference","document_id":"PTO-P-2021-0006-0002"},{"title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language in Patent Applications to Implement World Intellectual Property Organization Standard ST.26; Incorporation by Reference","document_id":"PTO-P-2021-0006-0001"}],"agency_name":null,"documents":[{"comment_count":0,"comment_start_date":"2021-07-06","updated_at":"2023-02-28T17:30:52.942-05:00","comment_url":"https://www.regulations.gov/commenton/PTO-P-2021-0006-0001","allow_late_comments":null,"id":"PTO-P-2021-0006-0001","comment_end_date":"2021-09-08","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"PTO-P-2021-0006","title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference"}],"document_number":"2021-14325","effective_on":null,"end_page":35443,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/07/06/2021-14325.xml","html_url":"https://www.federalregister.gov/documents/2021/07/06/2021-14325/standard-for-presentation-of-nucleotide-and-amino-acid-sequence-listings-using-xml-extensible-markup","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-14325?publication_date=2021-07-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-07-06/2021-14325/mods.xml","not_received_for_publication":null,"page_length":15,"page_views":{"count":1002,"last_updated":"2026-06-25 02:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-07-06/pdf/2021-14325.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-14325.pdf?1625229933","publication_date":"2021-07-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/07/06/2021-14325.txt","regulation_id_number_info":{"0651-AD53":{"issue":"202110","html_url":"https://www.federalregister.gov/regulations/0651-AD53/standard-for-presentation-of-nucleotide-and-amino-acid-sequence-listings-using-xml-extensible-markup","title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0651-AD53&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0651-AD53"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference","document_id":"PTO-P-2021-0006-0002"},{"title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language in Patent Applications to Implement World Intellectual Property Organization Standard ST.26; Incorporation by Reference","document_id":"PTO-P-2021-0006-0001"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0651-AD53/standard-for-presentation-of-nucleotide-and-amino-acid-sequence-listings-using-xml-extensible-markup","title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference"},"comments_count":0,"agency_id":"PTO","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=PTO-P-2021-0006","supporting_documents_count":2,"docket_id":"PTO-P-2021-0006","document_id":"PTO-P-2021-0006-0001","regulation_id_number":"0651-AD53","title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference","checked_regulationsdotgov_at":"2023-02-28T22:30:52Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":35429,"subtype":null,"title":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) in Patent Applications To Implement WIPO Standard ST.26; Incorporation by Reference","toc_doc":"Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language in Patent Applications to Implement World Intellectual Property Organization Standard ST.26; Incorporation by Reference","toc_subject":null,"topics":["Administrative practice and procedure","Biologics","Courts","Freedom of information","Incorporation by reference","Inventions and patents","Reporting and recordkeeping requirements","Small businesses"],"type":"Proposed Rule","volume":86}