Chapter 2400

Biotechnology

Chapter 2400 covers special rules for biotechnology applications including deposit requirements. Key rule: biological deposit must be made in a recognized repository (ATCC) before or on the application filing date — cannot be made after filing.

Core Concepts

Biological Deposits — 37 CFR 1.801 / MPEP 2402 Required when biological material is necessary for enablement and cannot be adequately described in words. Must deposit in recognized International Depositary Authority (IDA) — e.g., ATCC. Deposit must be made BEFORE or ON filing date — cannot deposit after filing.

Deposit Requirements — MPEP 2404 Must be accessible to public upon patent issuance. Must remain viable for term of patent plus 30 years. Depositor must comply with Budapest Treaty requirements if international deposit. Deposit accession number must be in specification.

Sequence Listings — MPEP 2421 Nucleotide and amino acid sequences of 10 or more specifically defined residues must be disclosed in sequence listing. Sequence listing submitted as XML file (WIPO ST.26 format for applications filed on or after July 1, 2022). Prior format: ASCII text (WIPO ST.25). Sequence listing is part of specification.

Enablement in Biotech — MPEP 2410 Deposit satisfies enablement requirement for biological material that cannot be described. If deposit is withdrawn or becomes non-viable, patent may be unenforceable. Replacement deposit must be made promptly.

Budapest Treaty — MPEP 2406 International treaty for recognition of deposits for patent purposes. Deposit made in one signatory IDA recognized in all member countries. Reduces need for multiple deposits.

Key Rules

1.Biological deposit: must be made BEFORE or ON filing date — not after

2.Deposit in recognized IDA (e.g., ATCC) — not just any repository

3.Deposit must remain viable for patent term plus 30 years

4.Accession number must appear in specification

5.Sequence listings required for sequences of 10+ residues

6.Current sequence listing format: XML (WIPO ST.26) for apps filed after July 1, 2022

7.Budapest Treaty: deposit in one IDA recognized in all member countries

EXAM TIP

Deposit timing rule is the most tested point: deposit must be made before or on the filing date. Post-filing deposits do not satisfy enablement. Also know that the deposit must be in a recognized IDA — an informal deposit with the inventor or a non-recognized lab does not qualify.

Common Traps

1.Thinking deposit can be made after filing date — must be before or on filing date

2.Depositing with non-recognized repository — must be recognized IDA under Budapest Treaty

3.Forgetting accession number must be in the specification

4.Missing that deposit must remain viable for patent term PLUS 30 years

5.Using old WIPO ST.25 format for new applications — now requires ST.26 XML

Search Terms

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Sections

2401Introduction

2402The Deposit Rules

2403Deposit of Biological Material

2404Need or Opportunity to Make a Deposit

2405Acceptable Depository

2406Time of Making an Original Deposit

2407Replacement or Supplement of Deposit

2408Term of Deposit

2409Viability of Deposit

2410Furnishing of Samples

2411Examination Procedures

2412The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include a Sequence Listing in XML file format

2413Content of a “Sequence Listing XML” and Form and Format of the “Sequence Listing XML” File

2414Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files Under 37 CFR 1.835

2415Applicability 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

2416Form Paragraphs

2417Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.26

2418WIPO Sequence Tool

2419Publishing of Patent Grants and Patent Application Publications with a “Sequence Listing XML”

2420The 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

2421Overview of the Sequence Rules under WIPO ST.25

2422Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.25

2423Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.25

2424Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25.

2425Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.25

2426Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 25

2427Form Paragraphs for Applications Subject to WIPO ST.25

2428Sample Statements under WIPO ST.25

2429Helpful Hints for Sequence Rules Compliance under WIPO ST.25

2430PatentIn Information

2431Sample “Sequence Listing” under WIPO ST.25

2433Box Sequence; Hand Delivery of a “Sequence Listing” and Computer Readable Forms

2434Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

2435Publishing of Patents and Patent Application Publications with a Lengthy “Sequence Listing”