MPEP 2400
Biotechnology
This is the Ninth Edition of the MPEP, Revision 10.2019, Last Revised in June 2020
Chapter 2400: Biotechnology
2401: Introduction
2402: The Deposit Rules
2403: Deposit of Biological Material
2403.01: Material Capable of Self- Replication
2403.02: Plant Material
2404: Need or Opportunity to Make a Deposit
2404.01: Biological Material That Is Known and Readily Available to the Public
2404.02: Biological Material That Can Be Made or Isolated Without Undue Experimentation
2404.03: Reference to a Deposit in the Specification
2405: Acceptable Depository
2406: Time of Making an Original Deposit
2406.01: Description in Application Specification
2406.02: Deposit After Filing Date - Corroboration
2406.03: Possible Loss of U.S. Filing Date in Other Countries
2407: Replacement or Supplement of Deposit
2407.01: In a Pending Application
2407.02: After a Patent Has Issued
2407.03: Failure to Replace
2407.04: Treatment of Replacement
2407.05: Exemption From Replacement
2407.06: Replacement May Not Be Recognized
2408: Term of Deposit
2409: Viability of Deposit
2410: Furnishing of Samples
2410.01: Conditions of Deposit
2410.02: Certification of Statement of Availability of Deposit
2411: Examination Procedures
2411.01: Rejections Based on Deposit Issue
2411.02: Replies to Rejections Based on Deposit Issue
2411.03: Application in Condition for Allowance Except for Deposit
2411.04: Reserved
2411.05: Content of Application with Respect to Deposited Material
2412: Reserved
2420: The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures - the Sequence Rules
2421: Overview of the Sequence Rules
2421.01: Definition of "Sequence Listing" and "CRF"
2421.02: Summary of the Requirements of the Sequence Rules
2421.03: Notification of a Failure to Comply
2421.04: Future Changes to the Sequence Rules
2422: Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications
2422.01: Nucleotide and/or Amino Acids Disclosures Requiring a Sequence Listing
2422.02: The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures
2422.03: Sequence Listing Submission
2422.03(a): Sequence Listings Submitted as ASCII Text Files via EFS-Web
2422.04: The Requirement for a Computer Readable Copy of the Official Copy of the Sequence Listing
2422.05: Request for Transfer of Computer Readable Form
2422.06: Requirement for Statement Regarding Content of Official and Computer Readable Copies of Sequence Listing
2422.07: Requirements for Compliance, Statements Regarding New Matter, and Sanctions for Failure to Comply
2422.08: Presumptions Regarding Compliance
2422.09: Box Sequence; Hand Delivery of Sequence Listings and Computer Readable Forms
2423: Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data
2423.01: Format and Symbols To Be Used in Sequence Listings
2423.02: Depiction of Coding Regions
2423.03: Presentation and Numbering of Sequences
2424: Requirements for Nucleotide and/or Amino Acid Sequences as Part of the Application Papers
2424.01: Informational Requirements for the Sequence Listing
2424.02: Sequence Listing Numeric Identifiers
2424.03: Additional Miscellaneous Requirements
2425: Form and Format for Nucleotide and/or Amino Acid Sequence Submissions in Computer Readable Form
2426: Amendments to or Replacement of Sequence Listing and Computer Readable Copy Thereof
2427: Form Paragraphs
2428: Sample Statements
2429: Helpful Hints for Compliance
2430: PatentIn Information
2431: Sample Sequence Listing
2432: Reserved
2434: Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences
2435: Publishing of Patents and Patent Application Publications with Lengthy Sequence Listings