MPEP § 2403 — MPEP § 2403
Current through: 2022-07-01

2403-Deposit of Biological Material 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2403 
 

 
 
 
 
 
 2403 Deposit of Biological Material [R-07.2022]

 37 CFR
 1.801 indicates that the rules pertaining to deposits for purposes of
 patents for inventions under 35 U.S.C. 101 are intended to relate to
 biological material. For the purposes of these rules, the term “biological material” is
 defined in terms of a non-exhaustive list of representative materials which can be
 deposited in accordance with the procedures defined in these rules. These rules are
 intended to address procedural matters in the deposit of biological material for patent
 purposes. They are not designed to decide substantive issues such as whether a deposit of a
 particular organism or material would be recognized or necessary for the purposes of
 satisfying the statutory requirements for patentability under 35 U.S.C. 112 . The
 issue of the need to make a deposit of biological material typically arises under
 35 U.S.C.
 112(a) with regard to the enablement requirement, although the issue
 may also arise under the written description or best mode requirement of the statute.
 Deposit issues may also arise under 35 U.S.C. 112(b) with respect to the
 claims.
 

 37 CFR
 1.801 does not attempt to identify what biological material either
 needs to be or may be deposited to comply with the requirements of 35 U.S.C. 112 . For
 the most part, this issue must be addressed on a case-by-case basis. Thus, while the Office
 does not currently contemplate that there would be any situations where a material that is
 not capable of self-replication either directly or indirectly would be acceptable as a
 deposit, an applicant is clearly not precluded by these rules from attempting to show in
 any given application why the deposit of such a material should be acceptable to satisfy
 the requirements of 35
 U.S.C. 112 . The examiner is cautioned against requiring that a
 specific biological material be deposited where the applicant can show that a deposit of
 starting material that is currently not available to the public would allow the skilled
 artisan to make and use the claimed invention. For example, where a claimed invention is
 drawn to a plant having novel properties produced by the insertion of a proprietary gene at
 a specific locus, the plant per se need not be deposited if deposit of a vector or
 hybridoma containing the gene would enable one of ordinary skill in the art to make and use
 the claimed invention without undue experimentation.
 

 
 2403.01 Material Capable of Self- Replication [R-08.2012]

 Biological material includes material that is capable of
 self-replication either directly or indirectly. Direct self-replication includes those
 situations where the biological material reproduces by itself. Representative examples
 of materials capable of self-replication are defined in the rule. Indirect
 self-replication is meant to include those situations where the biological material is
 only capable of replication when another self-replicating biological material is
 present. Self-replication after insertion in a host is one example of indirect
 self-replication. Examples of indirect replicating biological materials include viruses,
 phages, plasmids, symbionts, and replication defective cells. The list of representative
 examples of each type of replicating material includes viruses to demonstrate that the
 two lists in the rule are not intended to be mutually exclusive.
 

 

 
 2403.02 Plant Material [R-10.2019]

 Although plant material is included within the scope of the definition
 of biological material for purposes of patents for plant inventions under
 35 U.S.C.
 101 , the rules on deposits are not applicable to applications
 filed under the Plant Patent Act ( 35 U.S.C. 161 - 164 ). The Office
 is of the view that a deposit is not required under the present provisions of
 35 U.S.C.
 162 . Thus, a deposit is not necessary for the grant of a plant
 patent under the provisions of 35 U.S.C. 161 - 164 . See also
 MPEP §
 1605 . As with other biological material deposited for purposes
 of patents for inventions under 35 U.S.C. 101 , the deposit of plant
 material together with the written specification must enable those skilled in the art to
 make and use the claimed invention, in accordance with the requirements of
 35 U.S.C.
 112 . 
 

 As with some types of reproducible biological material, seeds can be
 reproduced only after a growing season which may be relatively long. Although the rules
 do not specify a specific number of seeds to be deposited to meet the requirements of
 these rules, so long as the number of seeds deposited complies with the requirements of
 the Budapest Treaty International Depositary Authority (IDA) where the deposit is made,
 the USPTO would consider such a compliant submission as satisfying the rules under
 37 CFR
 1.801 through 1.809 . Note that the American Type
 Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds;
 other IDAs may have different minimum requirements. Accordingly, any depositor should
 confirm that the number submitted to a specific IDA complies with that IDA's
 requirements for seed deposits.
 

 

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 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, Drawings 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 a “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 Qualifier Values 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-Amendment of a “Sequence Listing XML” in 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 if a “Sequence Listing XML” 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) When a “Sequence Listing XML” was Required 

 
 

 2416-Form Paragraphs 

 2417-Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.26 

 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” 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:50:45