MPEP § 2410 — MPEP § 2410
Current through: 2022-07-01

2410-Furnishing of Samples 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2400 

 Section 2410 
 

 
 
 
 
 
 2410 Furnishing of Samples [R-08.2012]

 
 37 CFR 1.808 Furnishing of samples. 

 
 (a) A deposit must be made under conditions that assure that:
 
 (1) Access to the deposit will be available during pendency of
 the patent application making reference to the deposit to one determined by
 the Commissioner to be entitled thereto under § 1.14 
 and 35 U.S.C. 122 , and
 

 (2) Subject to paragraph (b) of this section, 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.
 

 
 

 (b) The depositor may contract with the depository to require that
 samples of a deposited biological material shall be furnished only if a request
 for a sample, during the term of the patent:
 
 (1) Is in writing or other tangible form and dated;

 (2) Contains the name and address of the requesting party and
 the accession number of the deposit; and
 

 (3) Is communicated in writing by the depository to the
 depositor along with the date on which the sample was furnished and the name
 and address of the party to whom the sample was furnished.
 

 
 

 (c) 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 of the patent grant provided the
 request contains:
 
 (1) The name and address of the depository;

 (2) The accession number given to the deposit;

 (3) The patent number and issue date of the patent referring to
 the deposit; and
 

 (4) The name and address of the requesting party.

 
 

 
 

 
 2410.01 Conditions of Deposit [R-07.2015]

 37 CFR
 1.808 requires that the deposit of biological material be made
 under two conditions:
 

 
 (A) access to the deposit will be available during pendency of the
 patent application making reference to the deposit to one determined by the
 Commissioner to be entitled thereto under 37 CFR 1.14 and
 35 U.S.C.
 122 , and
 

 (B) with one exception, that all restrictions imposed by the
 depositor on the availability to the public of the deposited biological material
 be irrevocably removed upon the granting of the patent.
 

 
 The one exception that is permitted is specified in 37 CFR 1.808(b) 
 which permits the depositor to contract with the depository to require that samples of a
 deposited biological material shall be furnished only if a request for a sample, during
 the term of the patent, meets any one or all of the three conditions specified in this
 paragraph. These conditions are:
 

 
 (A) the request is in writing or other tangible form and dated;
 and/or
 

 (B) the request contains the name and address of the requesting party
 and the accession number of the deposit; and/or
 

 (C) the request is communicated in writing by the depository to the
 depositor along with the date on which the sample was furnished and the name and
 address of the party to whom the sample was furnished.
 

 
 It should be noted that this exception to the general rule that all
 restrictions will be removed must be strictly followed and that no variations of this
 explicit exception will be accepted as meeting the conditions of this section. Although
 this exception is consistent with the provisions in the Budapest Treaty and its
 implementing regulations ( Rule 11.4 ), other conditions on
 accessibility are permitted under the Budapest Treaty as prescribed by national law.
 Consequently, the mere indication that a deposit has been made and accepted under
 conditions prescribed by the Budapest Treaty would satisfy all conditions of these
 regulations except the requirement that all restrictions on access be removed on grant
 of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App.
 & Int. 1990).
 

 

 
 2410.02 Certification of Statement of Availability of
 Deposit [R-01.2024]
 

 Since the mere description of a deposit or identity of a deposit in a
 patent specification is not necessarily an indication that a requirement for deposit was
 made or that a deposit which complies with these rules has been made, accessibility to a
 deposited material referenced in a patent may depend on the satisfaction of conditions
 not apparent on the face of the patent. For these reasons, and upon request made to the
 U.S. Patent and Trademark 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 of the patent grant provided the request is made to a Director of
 Technology Center (TC) 1600, and contains the following information:
 

 
 (A) the name and address of the depository;

 (B) the accession number given to the deposit;

 (C) the patent number and issue date of the patent referring to the
 deposit; and
 

 (D) the name and address of the requesting party.

 
 Persons requesting a certificate of statement of
 availability of deposit should contact the TC 1600 Director's office directly, and
 should not submit a request via the examiner of record.
 

 The Office will not certify whether a deposit has been
 made under conditions which would make it available to the public until the issuance of
 a U.S. Patent referencing the deposit. For example, a request for such certification
 will not be considered where the request is filed with regard to a deposit referenced in
 an international application filed under the PCT, in an international application that
 entered the U.S. national stage, or any other U.S. national application, that has not
 yet issued as a patent.
 

 See also MPEP § 2404.01 .
 

 For those deposits made pursuant to the Budapest Treaty, the World
 Intellectual Property Organization provides a form (Form BP-12) for requesting a
 certification of legal entitlement to receive samples of deposited microorganisms
 pursuant to Rule 11.3(a) of the Regulations under the Budapest Treaty. The form is
 available at www.wipo.int/budapest/en/guide/ .
 

 

 [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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 03/09/2026 20:50:45