MPEP § 2407 — MPEP § 2407
Current through: 2022-07-01

2407-Replacement or Supplement of Deposit 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2407 
 

 
 
 
 
 
 2407 Replacement or Supplement of Deposit [R-08.2012]

 
 37 CFR 1.805 Replacement or supplement of deposit. 

 
 (a) A depositor, after receiving notice during the pendency of an
 application for patent, application for reissue patent or reexamination
 proceeding, that the depository possessing a deposit either cannot furnish samples
 thereof or can furnish samples thereof but the deposit has become contaminated or
 has lost its capability to function as described in the specification, shall
 notify the Office in writing, in each application for patent or patent affected.
 In such a case, or where the Office otherwise learns, during the pendency of an
 application for patent, application for reissue patent or reexamination
 proceeding, that the depository possessing a deposit either cannot furnish samples
 thereof or can furnish samples thereof but the deposit has become contaminated or
 has lost its capability to function as described in the specification, the need
 for making a replacement or supplemental deposit will be governed by the same
 considerations governing the need for making an original deposit under the
 provisions set forth in § 1.802(b) . A replacement or
 supplemental deposit made during the pendency of an application for patent shall
 not be accepted unless it meets the requirements for making an original deposit
 under these regulations, including the requirement set forth under
 §
 1.804(b) . A replacement or supplemental deposit made in
 connection with a patent, whether or not made during the pendency of an
 application for reissue patent or a reexamination proceeding or both, shall not be
 accepted unless a certificate of correction under § 1.323 is
 requested by the patent owner which meets the terms of paragraphs (b) and (c) of
 this section.
 

 (b) A request for certificate of correction under this section shall
 not be granted unless the certificate identifies:
 
 (1) The accession number for the replacement or supplemental
 deposit;
 

 (2) The date of the deposit; and

 (3) The name and address of the depository.

 
 

 (c) A request for a certificate of correction under this section
 shall not be granted unless the request is made promptly after the replacement or
 supplemental deposit has been made and the request:
 
 (1) Includes a statement of the reason for making the
 replacement or supplemental deposit;
 

 (2) Includes a statement from a person in a position to
 corroborate the fact, and stating that the replacement or supplemental
 deposit is of a biological material which is identical to that originally
 deposited;
 

 (3) Includes a showing that the patent owner acted diligently
 —
 
 (i) In the case of a replacement deposit, in making the
 deposit after receiving notice that samples could no longer be
 furnished from an earlier deposit; or
 

 (ii) In the case of a supplemental deposit, in making the
 deposit after receiving notice that the earlier deposit had become
 contaminated or had lost its capability to function as described in
 the specification;
 

 
 

 (4) Includes a statement that the term of the replacement or
 supplemental deposit expires no earlier than the term of the deposit being
 replaced or supplemented; and
 

 (5) Otherwise establishes compliance with these
 regulations.
 

 
 

 (d) A depositor’s failure to replace a deposit, or in the case of a
 patent, to diligently replace a deposit and promptly thereafter request a
 certificate of correction which meets the terms of paragraphs (b) and (c) of this
 section, after being notified that the depository possessing the deposit cannot
 furnish samples thereof, shall cause the application or patent involved to be
 treated in any Office proceeding as if no deposit were made.
 

 (e) In the event a deposit is replaced according to these
 regulations, the Office will apply a rebuttable presumption of identity between
 the original and the replacement deposit where a patent making reference to the
 deposit is relied upon during any Office proceeding.
 

 (f) A replacement or supplemental deposit made during the pendency of
 an application for patent may be made for any reason.
 

 (g) In no case is a replacement or supplemental deposit of a
 biological material necessary where the biological material, in accordance with
 §
 1.802(b) , need not be deposited.
 

 (h) No replacement deposit of a biological material is necessary
 where a depository can furnish samples thereof but the depository for national
 security, health or environmental safety reasons is unable to provide samples to
 requesters outside of the jurisdiction where the depository is located.
 

 (i) The Office will not recognize in any Office proceeding a
 replacement deposit of a biological material made by a patent owner where the
 depository could furnish samples of the deposit being replaced.
 

 
 

 37 CFR
 1.805 relates to the deposit of a biological material to replace or
 supplement a previous deposit. The term “replacement” is directed to those situations where
 one deposit is being substituted for another. An applicant may have greater latitude in
 replacing a deposit during the pendency of an application than after the patent is granted.
 Replacement will typically take place where the earlier deposit is no longer viable. The
 term “supplement” is directed to those situations where the earlier deposit is still viable
 in the sense that it is alive and capable of replication either directly or indirectly, but
 has lost a quality (e.g., purity, functionality) it allegedly possessed at the time the
 application was filed.
 

 
 2407.01 In a Pending Application [R-07.2015]

 Pursuant to 37 CFR 1.805(a) , an applicant is
 required to notify the Office when it obtains information that the depository possessing
 a deposit referenced in an application cannot furnish samples of the deposit. When the
 Office is so informed or otherwise becomes aware that samples of the deposited material
 cannot be furnished by the depository, the examiner will treat the application as if no
 deposit existed. A replacement or supplemental deposit must be made if access to the
 deposited material is necessary to satisfy the requirements for patentability under
 35 U.S.C.
 112 . A replacement or supplemental deposit will be accepted if it
 meets all the requirements for making an original deposit. 
 

 It should be noted that in a pending application, an applicant need not
 replace the identical material previously deposited, but may make an original deposit of
 a biological material which is specifically identified and described in the application
 as filed. Whether this alternative deposit will meet the requirements of
 35 U.S.C.
 112 with respect to the claimed subject matter must be resolved by
 the examiner on a case-by-case basis. The conditions in 37 CFR 1.802(b) 
 and 37 CFR
 1.804(b) must be satisfied.
 

 

 
 2407.02 After a Patent Has Issued [R-07.2015]

 A patent owner is required to notify the Office when it
 obtains information that a depository possessing a deposit referenced in a patent cannot
 furnish samples of the deposit. Failure to diligently replace the deposit and promptly
 thereafter request a certificate of correction which meets the terms of
 37 CFR
 1.805(b) and 37 CFR 1.805(c) will cause the
 patent involved to be treated in any Office proceeding as if no deposit were made.
 

 A replacement or supplemental deposit made in connection with a patent,
 whether or not made during the pendency of an application for reissue patent or a
 reexamination proceeding or both, shall not be accepted unless a certificate of
 correction under 37
 CFR 1.323 is requested which meets the terms of 37 CFR 1.805(b) 
 and 37 CFR
 1.805(c) for replacement or supplemental deposits. See
 MPEP §
 1411.01 for including changes that were made by a certificate
 of correction to the original patent grant in a reissue application, and
 MPEP §
 2219 for including a copy of any certificate of correction to
 the original patent grant as part of a request for ex parte 
 reexamination. 
 

 37 CFR
 1.805(b) and 37 CFR 1.805(c) specify the
 procedures that a patent owner may follow to ensure that a patent contains the
 appropriate information about a deposited biological material in the event that a
 replacement or supplemental deposit is made after the patent is granted.
 37 CFR
 1.805(b) describes the information which must be contained in the
 certificate of correction, whereas 37 CFR 1.805(c) describes the
 information which must be provided in the request to make the correction. 
 

 A request for a certificate of correction of a patent
 under 37 CFR
 1.805(b) and 37 CFR 1.805(c) will not be granted
 where no original deposit was made before or during the pendency of the application
 which matured into the patent. A patent defective because of lack of a necessary deposit
 is necessarily fatally defective for failure to comply with the first paragraph of
 35 U.S.C.
 112 . Reissue is not available in such cases. See In re
 Hay, 534 F.2d 917, 189 USPQ 790 (CCPA 1976).
 

 

 
 2407.03 Failure to Replace [R-08.2012]

 37 CFR
 1.805(d) sets forth the Office position that the failure to make a
 replacement deposit in a case pending before the Office, for example a reissue or
 reexamination proceeding, where a deposit is considered to be necessary to satisfy the
 requirements of 35 U.S.C. 112 , shall cause the application or patent involved to
 be treated in any Office proceeding as if no deposit were made. The provisions of
 37 CFR
 1.805(g) indicate that a replacement need not be made where, at
 the point in time when replacement would otherwise be necessary, access to the necessary
 biological material was otherwise available. For example, a replacement deposit would
 not be required under the circumstances where access to the necessary biological
 material was established through commercial suppliers. 
 

 

 
 2407.04 Treatment of Replacement [R-08.2012]

 37 CFR
 1.805(e) indicates that the Office will apply a rebuttable
 presumption of identity between the replacement deposit and an original deposit where a
 patent making reference to the deposit is relied on during any Office proceeding. This
 means that where a replacement deposit is permitted and made, the examiner will assume
 that the same material as described in the patent is accessible from the identified
 depository unless evidence to the contrary comes to the attention of the Office.
 

 An applicant for patent may make a replacement deposit during the
 pendency of the application for any reason. The provisions of 37 CFR 1.805(f) 
 recognize that since an original deposit may be made during the pendency of the
 application subject to the conditions of 37 CFR 1.809 , a replacement deposit
 logically cannot be held to any higher standard or any further requirements. 
 

 

 
 2407.05 Exemption From Replacement [R-08.2012]

 The provisions of 37 CFR 1.805(h) indicate that a
 replacement deposit is not required even though the depository cannot furnish samples,
 under certain conditions, to those requesting a sample outside of the jurisdiction where
 the depository is located. The conditions are specified in this paragraph as being
 limited to national security, health or environmental safety reasons. See also Article 5
 of the Budapest Treaty.
 

 

 
 2407.06 Replacement May Not Be Recognized [R-07.2015]

 37 CFR
 1.805(i) indicates that the Office will not recognize in any
 Office proceeding a replacement deposit made by the patent owner where the depository
 could furnish samples of the original deposit being replaced. The best evidence of what
 was originally deposited should not be lost through destruction or replacement if made
 in association with an existing patent. A supplemental deposit may be accepted in an
 Office proceeding, however, depending on the circumstances in each case.
 

 

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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 20:49:35