MPEP 2400 – Biotechnology

This page consolidates and annotates enforceable requirements under MPEP 2400 — Biotechnology, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Metric	Value	Share of total
Rules extracted	1,384	3.7%
Citations to Authorities	MPEP1,784 USC418 CFR2,254 PCT164	3.8%
Avg citations per rule	3.34
Topics covered	96 primary + 159 secondary	10.5%

Pages in this chapter

Page
MPEP § 2401 — Introduction1 rules
MPEP § 2402 — The Deposit Rules12 rules
MPEP § 2403 — Deposit of Biological Material10 rules
MPEP § 2403.01 — Material Capable of Self- Replication0 rules
MPEP § 2403.02 — Plant Material7 rules
MPEP § 2404 — Need or Opportunity to Make a Deposit12 rules
MPEP § 2404.01 — Biological Material That Is Known and Readily Available to the Public35 rules
MPEP § 2404.02 — Biological Material That Can Be Made or Isolated Without Undue Experimentation3 rules
MPEP § 2404.03 — Reference to a Deposit in the Specification2 rules
MPEP § 2405 — Acceptable Depository20 rules
MPEP § 2406 — Time of Making an Original Deposit7 rules
MPEP § 2406.01 — Description in Application Specification9 rules
MPEP § 2406.02 — Deposit After Filing Date – Corroboration3 rules
MPEP § 2406.03 — Possible Loss of U.S. Filing Date in Other Countries1 rules
MPEP § 2407 — Replacement or Supplement of Deposit15 rules
MPEP § 2407.01 — In a Pending Application7 rules
MPEP § 2407.02 — After a Patent Has Issued9 rules
MPEP § 2407.03 — Failure to Replace3 rules
MPEP § 2407.04 — Treatment of Replacement3 rules
MPEP § 2407.05 — Exemption From Replacement2 rules
MPEP § 2407.06 — Replacement May Not Be Recognized3 rules
MPEP § 2408 — Term of Deposit11 rules
MPEP § 2409 — Viability of Deposit17 rules
MPEP § 2410 — Furnishing of Samples5 rules
MPEP § 2410.01 — Conditions of Deposit5 rules
MPEP § 2410.02 — Certification of Statement of Availability of Deposit3 rules
MPEP § 2411 — Examination Procedures12 rules
MPEP § 2411.01 — Rejections Based on Deposit Issue19 rules
MPEP § 2411.02 — Replies to Rejections Based on Deposit Issue6 rules
MPEP § 2411.03 — Application in Condition for Allowance Except for Deposit5 rules
MPEP § 2411.05 — Content of Application with Respect to Deposited Material4 rules
MPEP § 2412 — The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include a Sequence Listing in XML file format13 rules
MPEP § 2412.01 — Overview of the Sequence Rules3 rules
MPEP § 2412.02 — Definition of “Sequence Listing XML”6 rules
MPEP § 2412.02(a) — “Enumeration of its residues”2 rules
MPEP § 2412.03 — Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML”7 rules
MPEP § 2412.03(a) — “Specifically Defined”1 rules
MPEP § 2412.03(b) — “Amino Acid”4 rules
MPEP § 2412.03(c) — “Modified Amino Acid”11 rules
MPEP § 2412.03(d) — “Nucleotide”4 rules
MPEP § 2412.03(e) — “Modified Nucleotide”3 rules
MPEP § 2412.04 — Use of Sequence Identifiers to Denote Sequences Disclosed in the Description, Drawings or Claims12 rules
MPEP § 2412.05 — Representation and Symbols for Nucleotide and/or Amino Acid Sequences1 rules
MPEP § 2412.05(a) — Use of Sequentially Numbered Sequence Identifiers in the “Sequence Listing XML”12 rules
MPEP § 2412.05(b) — Representation and Symbols of Nucleotide Sequence Data42 rules
MPEP § 2412.05(c) — Representation and Inclusion of Variants8 rules
MPEP § 2412.05(d) — Representation and Symbols of Amino Acid Sequence Data39 rules
MPEP § 2412.05(e) — Presentation of Special Situations8 rules
MPEP § 2412.06 — The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures8 rules
MPEP § 2412.07 — Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences1 rules
MPEP § 2413 — Content of a “Sequence Listing XML” and Form and Format of the “Sequence Listing XML” File3 rules
MPEP § 2413.01 — Parts of the “Sequence Listing XML”2 rules
MPEP § 2413.01(a) — The “Sequence Listing XML” is a Single File Encoded Using Unicode UTF-87 rules
MPEP § 2413.01(b) — The “Sequence Listing XML” Must Be Valid According To the DTD4 rules
MPEP § 2413.01(c) — The “Sequence Listing XML” Must Contain an XML Declaration4 rules
MPEP § 2413.01(d) — The “Sequence Listing XML” Must Contain a DOCTYPE Declaration4 rules
MPEP § 2413.01(e) — The “Sequence Listing XML” Must Contain a Root Element3 rules
MPEP § 2413.01(f) — The “Sequence Listing XML” Must Contain a General Information Part10 rules
MPEP § 2413.01(g) — The “Sequence Listing XML” Must Contain a Sequence Data Part90 rules
MPEP § 2413.01(h) — Language Dependent Free Text Qualifier Values in the English Language20 rules
MPEP § 2413.01(i) — Title Element in “Sequence Listing XML”5 rules
MPEP § 2413.02 — Form and Format of the XML file containing the “Sequence Listing XML”8 rules
MPEP § 2413.03 — How to Submit the “Sequence Listing XML”14 rules
MPEP § 2413.04 — Requirements Regarding Incorporation By Reference of the “Sequence Listing XML”8 rules
MPEP § 2413.05 — Presumptions Regarding Compliance3 rules
MPEP § 2414 — Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files Under 37 CFR 1.8355 rules
MPEP § 2414.01 — Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures5 rules
MPEP § 2414.02 — Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a)9 rules
MPEP § 2414.03 — Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b)10 rules
MPEP § 2414.04 — Translation of “Sequence Listing XML” is Not an Amended “Sequence Listing XML” under 37 CFR 1.835(b)9 rules
MPEP § 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 Authority13 rules
MPEP § 2414.06 — Amendment of a “Sequence Listing XML” in a Patent3 rules
MPEP § 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 Listing4 rules
MPEP § 2415.01 — Determining if a “Sequence Listing XML” Must be Submitted9 rules
MPEP § 2415.02 — Provisional Applications Containing Disclosures of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.8346 rules
MPEP § 2415.03 — Improper Submissions of “Sequence Listing” under 1.821(c) When a “Sequence Listing XML” was Required9 rules
MPEP § 2416 — Form Paragraphs52 rules
MPEP § 2417 — Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.2617 rules
MPEP § 2418 — WIPO Sequence Tool30 rules
MPEP § 2419 — Publishing of Patent Grants and Patent Application Publications with a “Sequence Listing XML”1 rules
MPEP § 2419.01 — Patent Grants and Patent Application Publications Containing a Non-Lengthy “Sequence Listing XML”1 rules
MPEP § 2419.02 — Patent Grants and Patent Application Publications Containing a Lengthy “Sequence Listing XML”4 rules
MPEP § 2419.03 — Patent Grants and Patent Application Publications Containing a “Sequence Listing XML” of 1GB or Larger8 rules
MPEP § 2421.01 — Definition of “Sequence Listing” and Computer Readable Form (CRF)9 rules
MPEP § 2421.02 — Summary of the Requirements of the Sequence Rules3 rules
MPEP § 2421.03 — Notification of a Failure to Comply15 rules
MPEP § 2422 — Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.2535 rules
MPEP § 2422.01 — Nucleotide and/or Amino Acids Disclosures Requiring a “Sequence Listing”43 rules
MPEP § 2422.02 — The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures7 rules
MPEP § 2422.03 — Sequence Listing Submission37 rules
MPEP § 2422.03(a) — “Sequence Listing” Submitted as ASCII Plain Text Files52 rules
MPEP § 2422.04 — The Requirement for a Computer Readable Copy of the “Sequence Listing”13 rules
MPEP § 2422.06 — Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form5 rules
MPEP § 2422.07 — Requirements for Compliance and Consequences of Non-Compliance19 rules
MPEP § 2422.08 — Presumptions Regarding Compliance3 rules
MPEP § 2423 — Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.2530 rules
MPEP § 2423.01 — Format and Symbols To Be Used in a “Sequence Listing”13 rules
MPEP § 2423.02 — Depiction of Coding Regions8 rules
MPEP § 2423.03 — Presentation and Numbering of Sequences16 rules
MPEP § 2424 — Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.6 rules
MPEP § 2424.01 — Informational Requirements for the “Sequence Listing”6 rules
MPEP § 2424.02 — “Sequence Listing” Numeric Identifiers8 rules
MPEP § 2424.03 — Additional Miscellaneous Requirements10 rules
MPEP § 2425 — Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.2511 rules
MPEP § 2426 — Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 2520 rules
MPEP § 2427 — Form Paragraphs for Applications Subject to WIPO ST.2565 rules
MPEP § 2428 — Sample Statements under WIPO ST.2510 rules
MPEP § 2429 — Helpful Hints for Sequence Rules Compliance under WIPO ST.2586 rules
MPEP § 2430 — PatentIn Information12 rules
MPEP § 2431 — Sample “Sequence Listing” under WIPO ST.251 rules
MPEP § 2433 — Box Sequence; Hand Delivery of a “Sequence Listing” and Computer Readable Forms5 rules
MPEP § 2434 — Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences7 rules
MPEP § 2435 — Publishing of Patents and Patent Application Publications with a Lengthy “Sequence Listing”13 rules