MPEP § 2406 — MPEP § 2406
Current through: 2022-07-01

2406-Time of Making an Original Deposit 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2406 
 

 
 
 
 
 
 2406 Time of Making an Original Deposit [R-07.2015]

 
 37 CFR 1.804 Time of making an original deposit. 

 
 (a) Whenever a biological material is specifically identified in an
 application for patent as filed, an original deposit thereof may be made at any
 time before filing the application for patent or, subject to § 1.809 ,
 during pendency of the application for patent.
 

 (b) When the original deposit is made after the effective filing date
 of an application for patent, the applicant must promptly submit a statement from
 a person in a position to corroborate the fact, stating that the biological
 material which is deposited is a biological material specifically identified in
 the application as filed.
 

 
 

 37 CFR
 1.804 specifies the time for making an original deposit to fulfill
 the requirements of 35 U.S.C. 112 . For the reasons discussed throughout this section, it
 is recommended that a deposit be made before the filing date of the application. However,
 for the purposes of complying with the requirements of 35 U.S.C. 112 , a deposit of a
 biological material may be made at any time before filing the application for patent or
 during the pendency of the application subject to the conditions of 37 CFR 1.809 . Where a
 deposit is needed to satisfy the requirements of 35 U.S.C. 112 and it is made during the
 pendency of the application, it must be made no later than the time period set by the
 examiner at the time the Notice of Allowance and Issue Fee Due is mailed. However, a
 necessary deposit need not be made by an applicant until the application is in condition
 for allowance so long as the applicant provides a written assurance that an acceptable
 deposit will be made on or before the payment of the issue fee. This written assurance must
 provide sufficiently detailed information to convince the examiner that there is no
 outstanding issue regarding deposits that needs to be resolved. Note that while
 37 CFR
 1.804 permits making a deposit after the filing date of an
 application, in many countries the deposit must be made before the filing date of the
 application. See MPEP §
 2406.03 . 
 

 Insofar as the rules do not permit post-issuance original deposits, the
 failure to make an original deposit in an application cannot be cured by filing a reissue
 application or instituting a reexamination proceeding. However, if an amendment of claims
 in a reexamination proceeding raises the need for a deposit, an original deposit may be
 made during the reexamination proceeding.
 

 
 2406.01 Description in Application Specification [R-07.2015]

 37 CFR
 1.804(a) specifies not only a permissible time frame for making an
 original deposit, but also specifies that the biological material deposited must be
 specifically identified in the application for patent as filed. The requirement for a
 specific identification is consistent with the description requirement of
 35 U.S.C.
 112 and provides an antecedent basis for the biological material
 which either has been or will be deposited before the patent is granted.
 

 The description in the Lundak application as filed (now U.S. Patent No.
 4,594,325) provides a suitable illustration of the specific identification and
 description which are required in an application as filed. In that application, an
 immortal B-cell line was disclosed and claimed. The cell line was referred to in the
 application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell
 line were also described in the application as filed. A deposit of the cell line was
 made with the American Type Culture Collection (ATCC) about a week after the application
 was filed in the United States. The United States Court of Appeals for the Federal
 Circuit held that the requirements of access by the Office to a sample of the cell line
 during pendency, and public access after grant, were met by Lundak's procedures. The
 Court further held that the addition of information designating the depository,
 accession number, and deposit date of the deposited cell line in ATCC after the filing
 date did not violate the prohibition against new matter in 35 U.S.C. 132 .
 In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
 However, it must be clear from the application as filed that the invention claimed and
 described in the specification “was fully capable of being reduced to practice (i.e., no
 technological problems, the resolution of which would require more than ordinary skill
 and reasonable time, remained in order to obtain an operative, useful process).”
 Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA
 1975), cert. denied, 424 U.S. 912 (1976). 
 

 

 
 2406.02 Deposit After Filing Date - Corroboration [R-08.2012]

 When the original deposit is made after the effective filing date of an
 application for patent, an applicant is required to promptly submit a statement from a
 person in a position to corroborate that the biological material which is deposited is a
 biological material specifically identified in the application (the filing date of which
 is relied upon) as filed. The nature of this corroboration will depend on the
 circumstances in the particular application under consideration, including the length of
 time between the application filing date and the date of deposit. While few, if any,
 situations can be imagined where the description requirement of 35 U.S.C. 112 can
 be satisfied where the biological material was not in existence at the time of filing,
 the rules will not preclude such a situation as there is no requirement in the patent
 law that an actual reduction to practice occur as a condition precedent to filing a
 patent application.
 

 

 
 2406.03 Possible Loss of U.S. Filing Date in Other
 Countries [R-07.2015]
 

 Those applicants intending to file patent applications in a country
 other than the United States relying upon biological material that must be deposited to
 satisfy the requirements of 35 U.S.C. 112 when the application
 is filed in the United States are cautioned that in many countries the deposit must be
 made before the filing date of the priority application in order to obtain foreign
 priority rights. Thus, while the deposit of a biological material subsequent to the
 effective filing date of a United States application may be relied upon to comply with
 35 U.S.C.
 112 , an applicant may not be able to rely on the filing date of
 such a U.S. application if a patent is sought in certain countries other than the United
 States.
 

 

 [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