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MPEP Chapter 2400 — Biotechnology

Chapter 2400 of the USPTO Manual of Patent Examining Procedure covers biotechnology. It runs to 35 file-level sections and 85 subsections, of which 34 carry substantive text and 1 is marked [Reserved].

Sections in this chapter

  • § 2401Introduction
  • § 2402The Deposit Rules
  • § 2403Deposit of Biological Material
  • § 2404Need or Opportunity to Make a Deposit
    • § 2404.01Biological Material That Is Known and Readily Available to the Public
    • § 2404.02Biological Material That Can Be Made or Isolated Without Undue Experimentation
    • § 2404.03Reference to a Deposit in the Specification
  • § 2405Acceptable Depository
  • § 2406Time of Making an Original Deposit
    • § 2406.01Description in Application Specification
    • § 2406.02Deposit After Filing Date - Corroboration
    • § 2406.03Possible Loss of U.S. Filing Date in Other Countries
  • § 2407Replacement or Supplement of Deposit
  • § 2408Term of Deposit
  • § 2409Viability of Deposit
  • § 2410Furnishing of Samples
  • § 2411Examination Procedures
    • § 2411.01Rejections Based on Deposit Issue
    • § 2411.02Replies to Rejections Based on Deposit Issue
    • § 2411.03Application in Condition for Allowance Except for Deposit
    • § 2411.04[Reserved]
    • § 2411.05Content of Application with Respect to Deposited Material
  • § 2412The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include a Sequence Listing in XML file format
    • § 2412.01Overview of the Sequence Rules
    • § 2412.02Definition of “Sequence Listing XML”
    • § 2412.02(a)“Enumeration of its residues”
    • § 2412.03Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”
    • § 2412.03(a)“Specifically Defined”
    • § 2412.03(b)“Amino Acid”
    • § 2412.03(c)“Modified Amino Acid”
    • § 2412.03(d)“Nucleotide”
    • § 2412.03(e)“Modified Nucleotide”
    • § 2412.04Use of Sequence Identifiers to Denote Sequences Disclosed in the Description, Drawings or Claims
    • § 2412.05Representation and Symbols for Nucleotide and/or Amino Acid Sequences
    • § 2412.05(a)Use of Sequentially Numbered Sequence Identifiers in the “Sequence Listing XML”
    • § 2412.05(b)Representation and Symbols of Nucleotide Sequence Data
    • § 2412.05(c)Representation and Inclusion of Variants
    • § 2412.05(d)Representation and Symbols of Amino Acid Sequence Data
    • § 2412.05(e)Presentation of Special Situations
    • § 2412.06The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures
    • § 2412.07Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences
  • § 2413Content of a “Sequence Listing XML” and Form and Format of the “Sequence Listing XML” File
    • § 2413.01Parts of the “Sequence Listing XML”
    • § 2413.01(a)The “Sequence Listing XML” is a Single File Encoded Using Unicode UTF-8
    • § 2413.01(b)The “Sequence Listing XML” Must Be Valid According To the DTD
    • § 2413.01(c)The “Sequence Listing XML” Must Contain an XML Declaration
    • § 2413.01(d)The “Sequence Listing XML” Must Contain a DOCTYPE Declaration
    • § 2413.01(e)The “Sequence Listing XML” Must Contain a Root Element
    • § 2413.01(f)The “Sequence Listing XML” Must Contain a General Information Part
    • § 2413.01(g)The “Sequence Listing XML” Must Contain a Sequence Data Part
    • § 2413.01(h)Language Dependent Free Text Qualifier Values in the English Language
    • § 2413.01(i)Title Element in “Sequence Listing XML”
    • § 2413.02Form and Format of the XML file containing the “Sequence Listing XML”
    • § 2413.03How to Submit the “Sequence Listing XML”
    • § 2413.04Requirements Regarding Incorporation By Reference of the “Sequence Listing XML”
    • § 2413.05Presumptions Regarding Compliance
  • § 2414Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files Under 37 CFR 1.835
    • § 2414.01Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures
    • § 2414.02Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a)
    • § 2414.03Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b)
    • § 2414.04Translation of “Sequence Listing XML” is Not an Amended “Sequence Listing XML” under 37 CFR 1.835(b)
    • § 2414.05Notifications for Failure to Submit a “Sequence Listing XML” in an International Application under the PCT to be Searched by the United States International Searching Authority or Examined by International Preliminary Examination Authority
    • § 2414.06Amendment of a “Sequence Listing XML” in a Patent
  • § 2415Applicability date of “Sequence Listing XML” Requirements to Applications Based on Filing Date of Application and Procedures for Failure to Submit Correct Format of Sequence Listing
    • § 2415.01Determining if a “Sequence Listing XML” Must be Submitted
    • § 2415.02Provisional Applications Containing Disclosures of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.834
    • § 2415.03Improper Submissions of “Sequence Listing” under 1.821(c) When a “Sequence Listing XML” was Required
  • § 2416Form Paragraphs
  • § 2417Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.26
  • § 2418WIPO Sequence Tool
  • § 2419Publishing of Patent Grants and Patent Application Publications with a “Sequence Listing XML”
    • § 2419.01Patent Grants and Patent Application Publications Containing a Non-Lengthy “Sequence Listing XML”
    • § 2419.02Patent Grants and Patent Application Publications Containing a Lengthy “Sequence Listing XML”
    • § 2419.03Patent Grants and Patent Application Publications Containing a “Sequence Listing XML” of 1GB or Larger
  • § 2420The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures under World Intellectual Property Office Standard ST.25 (WIPO ST.25) - the Sequence Rules
  • § 2421Overview of the Sequence Rules under WIPO ST.25
    • § 2421.01Definition of “Sequence Listing” and Computer Readable Form (CRF)
    • § 2421.02Summary of the Requirements of the Sequence Rules
    • § 2421.03Notification of a Failure to Comply
    • § 2421.04[Reserved]
  • § 2422Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.25
    • § 2422.01Nucleotide and/or Amino Acids Disclosures Requiring a “Sequence Listing”
    • § 2422.02The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures
    • § 2422.03Sequence Listing Submission
    • § 2422.03(a)“Sequence Listing” Submitted as ASCII Plain Text Files
    • § 2422.04The Requirement for a Computer Readable Copy of the “Sequence Listing”
    • § 2422.05[Reserved]
    • § 2422.06Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form
    • § 2422.07Requirements for Compliance and Consequences of Non-Compliance
    • § 2422.08Presumptions Regarding Compliance
    • § 2422.09[Reserved]
  • § 2423Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.25
    • § 2423.01Format and Symbols To Be Used in a “Sequence Listing”
    • § 2423.02Depiction of Coding Regions
    • § 2423.03Presentation and Numbering of Sequences
  • § 2424Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.
    • § 2424.01Informational Requirements for the “Sequence Listing”
    • § 2424.02“Sequence Listing” Numeric Identifiers
    • § 2424.03Additional Miscellaneous Requirements
  • § 2425Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.25
  • § 2426Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 25
  • § 2427Form Paragraphs for Applications Subject to WIPO ST.25
  • § 2428Sample Statements under WIPO ST.25
  • § 2429Helpful Hints for Sequence Rules Compliance under WIPO ST.25
  • § 2430PatentIn Information
  • § 2431Sample “Sequence Listing” under WIPO ST.25
  • § 2432[Reserved]
  • § 2433Box Sequence; Hand Delivery of a “Sequence Listing” and Computer Readable Forms
  • § 2434Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences
  • § 2435Publishing of Patents and Patent Application Publications with a Lengthy “Sequence Listing”