MPEP 2400

Biotechnology

Brief Summary:

The biotechnology chapter focuses on the rules for biological deposits and sequences. Due to the nature of biological based inventions, it may not always be sufficient for the applicant to list the steps necessary to create the product. In these cases, the PTO will request that a “deposit” is made so that members of the public desiring to use the particular product will have access to it. An example of this would be a specific tissue culture cell type.

In other cases, when the invention seeking to be patented involves a nucleotide or amino acid sequence, that sequence must be listed in the patent.

Key Terms:

Biological MaterialBiological Material refers to any material that is capable of self-replication either directly or indirectly, including microorganisms, cell lines, plasmids, and seeds, which may be subject to patenting if they meet certain criteria.
DepositA Deposit refers to the submission of a biological material to a recognized depository institution to meet the disclosure requirements for patent applications involving inventions that rely on such materials.
Sequence RulesSequence Rules refer to the standardized guidelines for disclosing nucleotide and amino acid sequences in patent applications, ensuring consistent and clear representation of genetic information.

37 CFR (Code of Federal Regulations):

37 CFR 1.809 – Examination procedures.
37 CFR 1.809 outlines the examination procedures for applications involving deposits of biological materials, specifying requirements for making such deposits accessible and ensuring compliance with patent regulations.
37 CFR 1.821 – Nucleotide and/or amino acid sequence disclosures in patent applications.
37 CFR 1.821 requires patent applications that disclose nucleotide and/or amino acid sequences to include a separate, standardized sequence listing, ensuring consistency and clarity in the presentation of these sequences.

Quick Statistics:

Number of Pages:  114 pgs
Sections:  2401 – 2435

List of Sections:

2401Introduction
2402The Deposit Rules
2403Deposit of Biological Material
 2403.01 Material Capable of Self- Replication
 2403.02 Plant Material
2404Need 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
2405Acceptable Depository
2406Time 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
2407Replacement 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
2408Term of Deposit
2409Viability of Deposit
2410Furnishing of Samples
 2410.01 Conditions of Deposit
 2410.02 Certification of Statement of Availability of Deposit
2411Examination 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
2412The 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
2413Content 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
2414Notification 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
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
 2415.01 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
2416Form Paragraphs
2417[Reserved]
2418WIPO Sequence Tool
2419Publishing 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
2020The 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
2021Overview 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]
2422Nucleotide 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]
2423Symbols 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
2424Requirements 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
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
2430PatentIng 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”

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