Brief Summary:
The biotechnology chapter focuses on the rules for biological deposits and sequences. Due to the nature of biological based inventions, it may not always be sufficient for the applicant to list the steps necessary to create the product. In these cases, the PTO will request that a “deposit” is made so that members of the public desiring to use the particular product will have access to it. An example of this would be a specific tissue culture cell type.
In other cases, when the invention seeking to be patented involves a nucleotide or amino acid sequence, that sequence must be listed in the patent.
Key Terms:
Biological Material | Biological Material refers to any material that is capable of self-replication either directly or indirectly, including microorganisms, cell lines, plasmids, and seeds, which may be subject to patenting if they meet certain criteria. |
Deposit | A Deposit refers to the submission of a biological material to a recognized depository institution to meet the disclosure requirements for patent applications involving inventions that rely on such materials. |
Sequence Rules | Sequence Rules refer to the standardized guidelines for disclosing nucleotide and amino acid sequences in patent applications, ensuring consistent and clear representation of genetic information. |
37 CFR (Code of Federal Regulations):
37 CFR 1.809 – Examination procedures. |
37 CFR 1.809 outlines the examination procedures for applications involving deposits of biological materials, specifying requirements for making such deposits accessible and ensuring compliance with patent regulations. |
37 CFR 1.821 – Nucleotide and/or amino acid sequence disclosures in patent applications. |
37 CFR 1.821 requires patent applications that disclose nucleotide and/or amino acid sequences to include a separate, standardized sequence listing, ensuring consistency and clarity in the presentation of these sequences. |
Quick Statistics:
Number of Pages: 114 pgs
Sections: 2401 – 2435
List of Sections:
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 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 “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 Qualifiers 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 Compliance with “Sequence Listing XML” for Any Amendment to 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 when a Sequence Listing in XML format 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)(1)-(3) When a “Sequence Listing XML” was Required | ||
2416 | Form Paragraphs | |
2417 | [Reserved] | |
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 | ||
2020 | 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 | |
2021 | 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 | PatentIng 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” |