MPEP 2400
Biotechnology

This is the Ninth Edition of the MPEP, Revision 07.2022, Last Revised in February 2023

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: The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include a Sequence Listing in XML file format

2412.01: Overview of the Sequence Rules

2412.02: Definition of "Sequence Listing XML"

2412.02(a): "Enumeration of its residues"

2412.03: Nucleotides 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"

2412.04: Use of Sequence Identifiers to Denote Sequences Disclosed in the Description or Claims

2412.05: Representation 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

2412.06: The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures

2412.07: Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

2413: Content of "Sequence Listing XML" and Form and Format of the "Sequence Listing XML" File

2413.01: Parts 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 Qualifiers in the English Language

2413.01(i): Title Element in "Sequence Listing XML"

2413.02: Form and Format of the XML file containing the "Sequence Listing XML"

2413.03: How to Submit the "Sequence Listing XML"

2413.04: Requirements Regarding Incorporation By Reference of the "Sequence Listing XML"

2413.05: Presumptions Regarding Compliance

2414: Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to "Sequence Listing XML" Files Under 37 CFR 1.835

2414.01: Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures

2414.02: Amendment to Add an Initial "Sequence Listing XML" under 37 CFR 1.835(a)

2414.03: Amendment Adding to, Deleting from, or Replacing Sequence Information in a "Sequence Listing XML" under 37 CFR 1.835(b)

2414.04: Translation of "Sequence Listing XML" is Not an Amended "Sequence Listing XML" under 37 CFR 1.835(b)

2414.05: Notifications 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

2414.06: Compliance with "Sequence Listing XML" for Any Amendment to a Patent

2415: Applicability 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

2415.01: Determining when a Sequence Listing in XML format must be submitted

2415.02: Provisional Applications Containing Disclosures of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.834

2415.03: Improper Submissions of "Sequence Listing" under 1.821(c)(1)-(3) When a "Sequence Listing XML" was Required

2416: Form Paragraphs

2417: Reserved

2418: WIPO Sequence Tool

2419: Publishing of Patent Grants and Patent Application Publications with a "Sequence Listing XML"

2419.01: Patent Grants and Patent Application Publications Containing a Non-Lengthy "Sequence Listing XML"

2419.02: Patent Grants and Patent Application Publications Containing a Lengthy "Sequence Listing XML"

2419.03: Patent Grants and Patent Application Publications Containing a "Sequence Listing XML" of 1GB or Larger

2420: The 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

2421: Overview of the Sequence Rules under WIPO ST.25

2421.01: Definition of "Sequence Listing" and Computer Readable Form (CRF)

2421.02: Summary of the Requirements of the Sequence Rules

2421.03: Notification of a Failure to Comply

2421.04: Reserved

2422: Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.25

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 Listing" Submitted as ASCII Plain Text Files

2422.04: The Requirement for a Computer Readable Copy of the "Sequence Listing"

2422.05: Reserved

2422.06: Requirement for Statement Regarding Information Contained in the "Sequence Listing" and Separate Computer Readable Form

2422.07: Requirements for Compliance and Consequences of Non-Compliance

2422.08: Presumptions Regarding Compliance

2422.09: Reserved

2423: Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.25

2423.01: Format and Symbols To Be Used in a "Sequence Listing"

2423.02: Depiction of Coding Regions

2423.03: Presentation and Numbering of Sequences

2424: Requirements for Content of a "Sequence Listing" Part of the Specification under WIPO ST.25

2424.01: Informational Requirements for the "Sequence Listing"

2424.02: "Sequence Listing" Numeric Identifiers

2424.03: Additional Miscellaneous Requirements

2425: Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.25

2426: Amendments to Add or Replace a "Sequence Listing" and CRF Copy Thereof Subject to WIPO ST. 25

2427: Form Paragraphs for Applications Subject to WIPO ST.25

2428: Sample Statements under WIPO ST.25

2429: Helpful Hints for Sequence Rules Compliance under WIPO ST.25

2430: PatentIn Information

2431: Sample "Sequence Listing" under WIPO ST.25

2432: Reserved

2433: Box Sequence; Hand Delivery of a "Sequence Listing" and Computer Readable Forms

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

2435: Publishing of Patents and Patent Application Publications with a Lengthy "Sequence Listing"