MPEP § 2404 — MPEP § 2404
Current through: 2022-07-01

2404-Need or Opportunity to Make a Deposit 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2400 

 Section 2404 
 

 
 
 
 
 
 2404 Need or Opportunity to Make a Deposit [R-08.2012]

 
 37 CFR 1.802 Need or opportunity to make a deposit. 

 
 (a) Where an invention is, or relies on, a biological material, the
 disclosure may include reference to a deposit of such biological material.
 

 (b) Biological material need not be deposited unless access to such
 material is necessary for the satisfaction of the statutory requirements for
 patentability under 35 U.S.C. 112 . If a deposit is
 necessary, it shall be acceptable if made in accordance with these regulations.
 Biological material need not be deposited, inter alia, if it is
 known and readily available to the public or can be made or isolated without undue
 experimentation. Once deposited in a depository complying with these regulations,
 a biological material will be considered to be readily available even though some
 requirement of law or regulation of the United States or of the country in which
 the depository institution is located permits access to the material only under
 conditions imposed for safety, public health or similar reasons.
 

 (c) The reference to a biological material in a specification
 disclosure or the actual deposit of such material by an applicant or patent owner
 does not create any presumption that such material is necessary to satisfy
 35 U.S.C.
 112 or that deposit in accordance with these regulations is
 or was required.
 

 
 

 37 CFR
 1.802(a) permits a deposit of a biological material to be referenced
 in a patent application where an invention is, or relies on, a biological material. The
 invention may rely on a biological material for the purposes of making or using the
 invention, either as a preferred mode or an alternative mode of operation. A reference to a
 deposit may be included in a specification even though the deposit is not required to
 satisfy the requirements of 35 U.S.C. 112 .
 

 There is no necessary implication or presumption that can or should be
 made about the need for a deposit simply because reference to a deposit is made in an
 application disclosure, as noted in paragraph (c). As noted in paragraph (b), biological
 material need not be deposited unless access to such material is necessary for the
 satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 and
 that access is not otherwise available in the absence of a deposit. Where a deposit is
 required to provide the necessary access, a deposit is acceptable for patent purposes only
 where it is made in accordance with these regulations. Even where access to biological
 material is required to satisfy these statutory requirements, a deposit may not be
 necessary if access sufficient to satisfy these requirements is otherwise available.
 

 
 2404.01 Biological Material That Is Known and Readily Available to the
 Public [R-07.2015]
 

 In an application where the invention required access to specific
 biological material, an applicant could show that the biological material is accessible
 because it is known and readily available to the public. The concepts of “known and
 readily available” are considered to reflect a level of public accessibility to a
 necessary component of an invention disclosure that is consistent with an ability to
 make and use the invention. To avoid the need for a deposit on this basis, the
 biological material must be both known and readily available - neither concept alone is
 sufficient. A material may be known in the sense that its existence has been published,
 but is not available to those who wish to obtain that particular known biological
 material. Likewise, a biological material may be available in the sense that those
 having possession of it would make it available upon request, but no one has been
 informed of its existence.
 

 The Board has held that a description of the precise geographic
 location of marine tunicates, as a biological material, used in a claimed invention was
 adequate to satisfy the enablement requirement of 35 U.S.C. 112 . See Ex Parte
 Rinehart, 10 USPQ2d 1719 (Bd. Pat. App. & Int. 1985). The term
 “readily” used in the phrase “known and readily available” is considered appropriate to
 define that degree of availability which would be reasonable under the circumstances. If
 the biological material and its natural location can be adequately described so that one
 skilled in the art could obtain it using ordinary skill in the art, the disclosure would
 appear to be sufficient to meet the enablement requirement of 35 U.S.C. 112 
 without a deposit so long as its degree of availability is reasonable under the
 circumstances. 
 

 By showing that a biological material is known and readily available or
 by making a deposit in accordance with these rules, applicant does not guarantee that
 such biological material will be available forever. Public access during the term of the
 patent may affect the enforceability of the patent. Although there is a public interest
 in the availability of a deposited biological material during and after the period of
 enforceability of the patent, there should not be any undue concern about continued
 access to the public. See 37 CFR 1.806 (the term of deposit is
 “at least thirty (30) years and at least five (5) years after the most recent request”
 for a sample; the agreement sufficiently ensures that the deposit will be “available
 beyond the enforceable life of the patent”). Unless there is a reasonable basis to
 believe that the biological material will cease to be available during the enforceable
 life of the patent, current availability would satisfy the requirement. The incentives
 provided by the patent system should not be constrained by the mere possibility that a
 disclosure that was once enabling would become non-enabling over a period of time
 through no fault of the patentee. In re Metcalfe, 410 F.2d 1378, 161
 USPQ 789 (CCPA 1969).
 

 If an applicant has adequately established that a biological material
 is known and readily available, the Office will accept that showing. In those instances,
 however, the applicant takes the risk that the material may cease to be known and
 readily available. Such a defect cannot be cured by reissue after the grant of a
 patent.
 

 On the other hand, Ex parte Humphreys, 24 USPQ2d
 1255 (Bd. Pat. App. & Int. 1992), held that the only manner in which applicants
 could satisfy their burden of assuring public access to the needed biological material,
 and, thereby, compliance with the enablement requirement of 35 U.S.C. 112 , was
 by making an appropriate deposit. The fact that applicants and other members of the
 public were able to obtain the material in question from a given depository prior to and
 after the filing date of the application in issue did not establish that upon issuance
 of a patent on the application that such material would continue to be accessible to the
 public. The applicants did not make of record any of the facts and circumstances
 surrounding their access to the material in issue from the depository, nor was there any
 evidence as to the depository’s policy regarding the material if a patent would have
 been granted. Further, there was no assurance that the depository would have allowed
 unlimited access to the material if the application had matured into a patent.
 

 There are many factors that may be used as indicia that a biological
 material is known and readily available to the public. Relevant factors include
 commercial availability, references to the biological material in printed publications,
 declarations of accessibility by those working in the field, evidence of predictable
 isolation techniques, or an existing deposit made in accordance with these rules. Each
 factor alone may or may not be sufficient to demonstrate that the biological material is
 known and readily available. Those applicants that rely on evidence of accessibility
 other than a deposit take the risk that the patent may no longer be enforceable if the
 biological material necessary to satisfy the requirements of 35 U.S.C. 112 
 ceases to be accessible.
 

 The Office will accept commercial availability as evidence that a
 biological material is known and readily available only when the evidence is clear and
 convincing that the public has access to the material. See the final rule entitled
 “ Deposit of Biological Materials for Patent Purposes, ” 54 FR
 34864, 34875 (August 22, 1989). A product could be commercially available but only at a
 price that effectively eliminates accessibility to those desiring to obtain a sample.
 The relationship between the applicant relying on a biological material and the
 commercial supplier is one factor that would be considered in determining whether the
 biological material was known and readily available. However, the mere fact that the
 biological material is commercially available only through the patent holder or the
 patent holder’s agents or assigns shall not, by itself, justify a finding that the
 necessary material is not readily available, absent reason to believe that access to the
 biological material would later be improperly restricted.
 

 The mere reference to a deposit or the biological material itself in
 any document or publication does not necessarily mean that the deposited biological
 material is readily available. Even a deposit made under the Budapest Treaty and
 referenced in a United States or foreign patent document would not necessarily meet the
 test for known and readily available unless the deposit was made under conditions that
 are consistent with those specified in these rules, including the provision that
 requires, with one possible exception ( 37 CFR 1.808(b) ), that all
 restrictions on the accessibility be irrevocably removed by the applicant upon the
 granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat.
 App. & Int. 1990).
 

 A deposit of biological material cited in a U.S. patent need not be
 made available if it was not required to satisfy 35 U.S.C. 112 . For this reason,
 37 CFR
 1.808(c) provides that upon request made to the Office, the Office
 will certify whether a deposit has been stated to have been made under conditions which
 make it available to the public as of the issue date. See 37 CFR 1.808(c) 
 and MPEP §
 2410.02 for the requirements of the request. The Office will
 not certify that the aforementioned statement has been made unless: 
 

 
 (A) the deposit was necessary to overcome a rejection under
 35 U.S.C.
 112 ,
 

 (B) there is, in the record, a statement by the examiner that a
 rejection would have been made “but for” the deposit (assumes deposit information
 in record, as filed), 
 

 (C) the record otherwise clearly indicates that the deposit was made
 under Budapest Treaty, and that all restrictions imposed by the depositor on the
 availability to the public of the deposited material will be irrevocably removed
 upon the granting of the patent (with the possible exception of requiring the
 request for the deposit to be in the format specified in 37 CFR
 1.808(b) ), or
 

 (D) the record otherwise clearly indicates that an
 acceptable non-Budapest Treaty deposit was made and that all restrictions imposed
 by the depositor on the availability to the public of the deposited material will
 be irrevocably removed upon the granting of the patent (with the possible
 exception of requiring the request for the deposit to be in the format specified
 in 37 CFR
 1.808(b) ).
 

 
 If a deposit is not made under the conditions set forth in
 37 CFR
 1.808(a) , the deposit cannot be relied upon for other purposes,
 e.g., the deposit cannot be relied upon by a third party to establish “known” and
 “readily available” in another application. See 37 CFR 1.808 and
 MPEP §
 2410 and § 2410.02 .
 

 Once a deposit is made in a depository complying with these rules, and
 under conditions complying with these rules, a biological material will be considered to
 be readily available even though some requirement of law or regulation in the United
 States or in the country where the depository institution is located permits access to
 the material only under conditions imposed for health, safety or similar reasons. This
 provision is consistent with the Budapest Treaty (Article 5) and is designed to permit
 the patenting of inventions involving materials having restricted distribution, where
 the restrictions are imposed for the public, as opposed to the private, welfare.
 

 

 
 2404.02 Biological Material That Can Be Made or Isolated Without Undue
 Experimentation [R-08.2012]
 

 Applicant may show that a deposit is not necessary even though specific
 biological materials are required to practice the invention if those biological
 materials can be made or isolated without undue experimentation. Deposits may be
 required to support the claims if an isolation procedure requires undue experimentation
 to obtain the desired biological material. Ex Parte Jackson, 217 USPQ
 804 (Bd. App. 1982). No deposit is required, however, where the required biological
 materials can be obtained from publicly available material with only routine
 experimentation and a reliable screening test. Tabuchi v. Nubel, 559
 F.2d 1183, 194 USPQ 521 (CCPA 1977); Ex Parte Hata, 6 USPQ2d 1652
 (Bd. Pat. App. & Int. 1987).
 

 

 
 2404.03 Reference to a Deposit in the Specification [R-08.2012]

 37 CFR
 1.802(c) specifically provides that the mere reference to a
 biological material in the specification disclosure or the actual deposit of such
 material does not create any presumption that such referenced or deposited material is
 necessary to satisfy 35 U.S.C. 112 , or that a deposit in accordance with these
 regulations is or was required. It should be noted, however, that a reference to a
 biological material, present in an application upon filing, may form the basis for
 making a deposit, where required, after the filing date of a given application but that
 the reference to the biological material, itself, cannot be added after filing without
 risking the prohibited introduction of new matter ( 35 U.S.C. 132 ). See the discussion
 of the Lundak application in MPEP § 2406.01 .
 

 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 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