What are the requirements for submitting biological sequence listings in patent applications?

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Source: FAQ (MPEP-Based) BlueIron Update: 2024-09-09 10 Rules 5 Related FAQs This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice. The requirements for submitting biological sequence listings in patent applications depend on the filing date of the application: For applications filed before July 1, 2022: A “Sequence Listing” must be submitted as an ASCII plain text file in compliance with 37 CFR 1.821-1.824 . It can be submitted via the USPTO patent electronic filing system or on read-only optical disc. For applications filed on or after July 1, 2022: A “Sequence Listing XML” must be submitted as an XML file in compliance with 37 CFR 1.831-1.834 . It can be submitted via the USPTO patent electronic filing system or on read-only optical disc. In both cases, the sequence listing must include nucleotide and/or amino acid sequences as defined in the respective CFR sections. Detailed information can be found in MPEP §§ 2420 et seq. for pre-July 1, 2022 applications and MPEP §§ 2412-2419 for applications filed on or after July 1, 2022. Related Rules from the Manual of Patent Examining Procedure 10 rules Collapse Requirement for Sequence Listings in XML Format MPEP 2412 Sequence Listing Must Be In XML Format MPEP 2412 Permitted Sequence Listing Must Be In XML Format MPEP 2412 Required Access to Nucleotide and Amino Acid Sequence Material at NARA MPEP 2412 Sequence Listing Must Be In XML Format MPEP 2412 Contact USPTO for Patent Application Inspection MPEP 2412 Nucleotide and Amino Acid Sequences Must Be in XML Format MPEP 1823.02 Required Nucleotide and Amino Acid Sequences Must Be in XML Format MPEP 1848 Required Sequence Listings Must Be In XML Format MPEP 2412 Single Sequence Listing for All IPOs MPEP 2412 Permitted Other Related FAQs 5 FAQs Collapse How do I submit a biological sequence listing for a patent application file...