MPEP § 2405 — MPEP § 2405
Current through: 2022-07-01

2405-Acceptable Depository 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

 Skip over navigation 
 
 
 
 
 
 
 
 search for patents | search for trademarks 

 
 
 
 
 
 
 
 
 
 
 
 Search 
 
 
 

 
 

 
 
 
 
 
 PATENTS 
 
 Patent Search 

 
 Patent Process 

 
 Patent Classification 

 
 Patent Forms 

 
 Statistics 

 
 Electronic Business Center 

 
 Patent Laws, Regulations, Policies & Procedures 

 
 Resources and Guidance 

 
 Office of Data Management 

 
 Announcements 

 
 Initiatives & Events 

 
 International Protection 

 
 Employee Locator 

 
 Contact Patents 

 

 

 
 TRADEMARKS 
 
 Trademark Search 

 
 Trademarks Process 

 
 News & Notices 

 
 Manuals, Guides, Official Gazette 

 
 Laws & Regulations 

 
 Online Filing 

 
 Contact Trademarks 

 

 

 
 IP LAW & POLICY 
 
 Rulemaking 

 
 IP Policy and Enforcement 

 
 Protecting IP Overseas 

 
 Training and Education 

 
 Training Programs & Conferences 

 
 Office of Governmental Affairs 

 
 Office of Chief Economist 

 
 Boards and Counsel 

 

 

 
 PRODUCTS & SERVICES 
 
 Electronic Data Products 

 
 XML Resources 

 
 XML Resources - Retrospective 

 
 USPTO Contact Center Order Form 

 
 Services 

 
 Locate Libraries 

 
 Training/Events 

 
 Online Services Hub 

 

 

 
 INVENTORS 
 
 Patents for Inventors 

 
 Trademarks for Inventors 

 
 Inventors Assistance 

 
 Education and Information 

 
 Scam Prevention 

 
 Pro Se and Pro Bono 

 
 Current Events 

 
 State Resources 

 
 InventorsEye Newsletter 

 

 

 
 NEWS & NOTICES 
 
 Subscription Center 

 
 Press Releases 

 
 Testimony and Speeches 

 
 Director's Forum 

 
 Systems Status 

 
 Emergency Notices 

 
 USPTO Videos 

 
 Official Gazette 

 
 Federal Register Notices 

 
 Event Calendar 

 

 

 
 FAQs 
 
 Patents FAQs 

 
 Trademarks FAQs 

 
 Assignments 

 
 Security 

 
 Musicians and Artists 

 
 Browser Plugins 

 
 Other Web Resources 

 

 

 
 ABOUT US 
 
 USPTO Leadership 

 
 USPTO Organization 

 
 USPTO Offices 

 
 Careers 

 
 Budget, Performance, and Planning 

 
 Statistics 

 
 Vendor Information 

 
 Public Advisory Committees 

 
 National Medal of Technology and Innovation 

 
 IP in Motion 

 
 Contact Us 

 

 

 
 
 

 

 
 

 
 
 
 
 Home Page 

 
 Patents 

 
 Patent Laws, Regulations, Policies & Procedures 

 
 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2405 
 

 
 
 
 
 
 2405 Acceptable Depository [R-07.2015]

 
 37 CFR 1.803 Acceptable depository. 

 
 (a) A deposit shall be recognized for the purposes of these
 regulations if made in
 
 (1) any International Depositary Authority (IDA) as established
 under the Budapest Treaty on the International Recognition of the Deposit of
 Microorganisms for the Purposes of Patent Procedure, or
 

 (2) any other depository recognized to be suitable by the
 Office. Suitability will be determined by the Commissioner on the basis of
 the administrative and technical competence, and agreement of the depository
 to comply with the terms and conditions applicable to deposits for patent
 purposes. The Commissioner may seek the advice of impartial consultants on
 the suitability of a depository. The depository must:
 
 (i) Have a continuous existence;

 (ii) Exist independent of the control of the
 depositor;
 

 (iii) Possess the staff and facilities sufficient to
 examine the viability of a deposit and store the deposit in a manner
 which ensures that it is kept viable and uncontaminated;
 

 (iv) Provide for sufficient safety measures to minimize
 the risk of losing biological material deposited with it;
 

 (v) Be impartial and objective;

 (vi) Furnish samples of the deposited material in an
 expeditious and proper manner; and
 

 (vii) Promptly notify depositors of its inability to
 furnish samples, and the reasons why.
 

 
 

 
 

 (b) A depository seeking status under paragraph (a)(2) of this
 section must direct a communication to the Commissioner which shall:
 
 (1) Indicate the name and address of the depository to which
 the communication relates;
 

 (2) Contain detailed information as to the capacity of the
 depository to comply with the requirements of paragraph (a) (2) of this
 section, including information on its legal status, scientific standing,
 staff and facilities;
 

 (3) Indicate that the depository intends to be available, for
 the purposes of deposit, to any depositor under these same conditions;
 

 (4) Where the depository intends to accept for deposit only
 certain kinds of biological material, specify such kinds;
 

 (5) Indicate the amount of any fees that the depository will,
 upon acquiring the status of suitable depository under paragraph (a) (2) of
 this section, charge for storage, viability statements and furnishings of
 samples of the deposit.
 

 
 

 (c) A depository having status under paragraph (a)(2) of this section
 limited to certain kinds of biological material may extend such status to
 additional kinds of biological material by directing a communication to the
 Commissioner in accordance with paragraph (b) of this section. If a previous
 communication under paragraph (b) of this section is of record, items in common
 with the previous communication may be incorporated by reference.
 

 (d) Once a depository is recognized to be suitable by the
 Commissioner or has defaulted or discontinued its performance under this section,
 notice thereof will be published in the Official Gazette of the Patent and
 Trademark Office.
 

 
 

 37 CFR
 1.803 indicates that a depository will be recognized as acceptable
 for the purposes of these regulations if it is either an International Depositary Authority
 (IDA) established under the Budapest Treaty, or if it is a depository recognized as
 suitable by the Commissioner. After the effective date of these regulations, a deposit of
 biological material which is made in a depository which is not recognized as acceptable
 under this regulation will not be considered as satisfying the requirements of
 35 U.S.C.
 112 . See Ex parte Humphreys, 24 USPQ2d 1255 (Bd.
 Pat. App. & Int. 1992). On the other hand, if a deposit is not required to satisfy the
 requirements of 35 U.S.C.
 112 , it is permissible to make reference to such a deposit even
 though it may not be in a depository or made under the conditions which are acceptable
 under these regulations. As new depositories are recognized as suitable by the
 Commissioner, their identity will be announced in the Official Gazette. 

 An organization may be recognized as suitable by the Office if the
 procedure and conditions specified in 37 CFR 1.803(a)(2) and
 37 CFR
 1.803(b) are followed. Generally, it is not the intention of the
 Office to recognize as suitable any organization where the need for a suitable depository
 for patent purposes is being met by depositories recognized as IDAs under the Budapest
 Treaty. Suitability will be judged by the Commissioner, based on need and the information
 supplied by the organization seeking status, and information obtained from other sources
 that may be consulted.
 

 While there is a desire to provide flexibility to a patent applicant in
 selecting an appropriate depository, these rules are not intended to permit each patent
 applicant to become its own depository since both the patent owner and the public have an
 interest in the continued availability and accessibility of the deposit during the
 enforceable life of the patent, and the public has a continuing interest in its
 availability when the patent is no longer enforceable. The concept of a depository
 independent of the control of the depositor or an IDA as an acceptable depository is based
 on the need and desire to ensure the safe and reliable storage of a deposited biological
 material under circumstances that are substantially free of the opportunity for intentional
 mishandling or negligent handling of the deposited material. The use of an independent
 depository or internationally recognized depository will tend to preserve the integrity of
 the deposit process against those that may accidentally alter the deposited material, may
 wish to tamper with the deposited material or may wish to resume control of its
 availability when the patent is no longer enforceable, and will tend to preserve the
 interest of the public in the access to the biological material once the term of the patent
 expires.
 

 When a depository having status under 37 CFR 1.803(a)(2) seeks to change the
 kinds of biological materials that it will accept and maintain for the purposes of these
 rules, a communication requesting such a change should be directed to the Commissioner
 containing the information requested in 37 CFR 1.803(b) . When such a change is
 requested, the requesting depository should provide a complete list of the kinds of
 biological materials it will accept.
 

 37 CFR
 1.803(d) indicates that once a depository is recognized as suitable
 for the purposes of this rule, or has defaulted or discontinued its performance under this
 section, notice thereof will be published in the Official Gazette of the
 Patent and Trademark Office. The mere fact that a deposit has been made in an IDA
 recognized under the Budapest Treaty does not mean that the terms of the deposit meet
 either the requirements of the Budapest Treaty or the deposit regulations. Many of the
 depositories recognized under the Budapest Treaty have many different arrangements under
 which biological material may be stored.
 

 The World Intellectual Property Organization (WIPO) publishes a Guide to
 the Deposit of Micro-organisms under the Budapest Treaty (WIPO Publication No. 661 (E)) on
 the procedures and requirements concerning the deposit of biological material, including
 procedures for obtaining a sample of deposited material, in each of the international
 depository authorities. The Guide and a list of current IDAs under the Budapest Treaty are
 available at www.wipo.int/treaties/en/registration/budapest/ .
 

 [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” 

 

 

 
 

 
 
 

 
 

 

 
 
 Accessibility 

 Privacy Policy 

 Terms of Use 

 Security 

 Emergencies/Security Alerts 

 Information Quality Guidelines 

 
 

 
 
 Federal Activities Inventory Reform (FAIR) Act 

 Notification and Federal Employee Antidiscrimination and Retaliation (NoFEAR) Act 

 Budget & Performance 

 Freedom of Information Act (FOIA) 

 
 

 
 
 Department of Commerce NoFEAR Act Report 

 Regulations.gov 

 STOP!Fakes.gov 

 Department of Commerce 

 USA.gov 

 
 

 
 
 Strategy Targeting Organized Piracy (STOP!) 

 Careers 

 Site Index 

 Contact Us 

 Submit Feedback 

 
 

 
 This page is owned by Patents.

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