Manual of Patent Examining Procedure (MPEP)
Chapter 2400: Biotechnology

Ninth Edition of the MPEP, Revision 07.2015, Last Revised in November 2015

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

2412‑2419: [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

2432‑2433: [Reserved]

2434: Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

2435: Publishing of Patents and Patent Application Publications with Lengthy Sequence Listings