Chapter 2400 Biotechnology

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2402

The Deposit Rules

Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112.

2403

Deposit of Biological Material

37 CFR 1.801 Biological Material

For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. 101, the term biological material shall include material that is capable of self-replication either directly or indirectly. Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles and other non-living material existing in and reproducible from a living cell may be deposited by deposit of the host cell capable of reproducing the non-living material.

2403.01

Material Capable of Self-Replication

Biological material includes material that is capable of self-replication either directly or indirectly.

2403.02

Plant Material

A deposit is not necessary for the grant of a plant patent under the provisions of 35 U.S.C. 161- 164. As with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112.

hat is the mininum number of seeds that must be deposited to be considered by the Office?

2500

2404

Need or Opportunity to Make a Deposit

37 CFR 1.802(a) permits a deposit of a biological material to be referenced in a patent application where an invention is, or relies on, a biological material. The invention may rely on a biological material for the purposes of making or using the invention, either as a preferred mode or an alternative mode of operation. A reference to a deposit may be included in a specification even though the deposit is not required to satisfy the requirements of 35 U.S.C. 112.

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

a reference to a biological material, present in an application upon filing, may form the basis for making a deposit, where required, after the filing date of a given application but that the reference to the biological material, itself, cannot be added after filing without risking the prohibited introduction of new matter (35 U.S.C. 132). See the discussion of the Lundak application in MPEP § 2406.01. - See more at: http://www.wikilawschool.net/wiki/MPEP_2400#sthash.r1onQWb8.dpuf

2405

Acceptable 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.

2406

Time of Making an Original Deposit

2406.01

Description in Application Specification
37 CFR 1.804(a)
requirement for a specific identification consistent with the description requirement of the first paragraph 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.

2406.02

Deposit After Filing Date-Corroboration

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. - See more at: http://www.wikilawschool.net/wiki/MPEP_2400#sthash.r1onQWb8.dpuf

2406.03

Possible Loss of U.S. Filing Date in Other Countries

caution that in many countries the deposit must be made before the filing date of the priority application in order to obtain foreign priority rights.

2407

Replacement or Supplement of Deposit

2407.01

Replacement or Supplement of Deposit
IN A PENDING APPLICATION

2407.02

Replacement or Supplemental of Deposit
AFTER A PATENT HAS ISSUED

2407.03

Failure to Replace

37 CFR 1.805(d) sets forth the Office position that the failure to make a replacement deposit in a case pending before the Office, for example a reissue or reexamination proceeding, where a deposit is considered to be necessary to satisfy the requirements of 35 U.S.C. 112, shall cause the application or patent involved to be treated in any Office proceeding as if no deposit were made. - See more at: http://www.wikilawschool.net/wiki/MPEP_2400#sthash.r1onQWb8.dpuf

2407.04

Treatment of Replacement
37 CFR 1.805(e)
where a replacement deposit is permitted and made, the examiner will assume that the same material as described in the patent is accessible from the identified depository unless evidence to the contrary comes to the attention of the Office

2407.05

Exemption From Replacement

2407.06

Replacement May Not Be Recognized

2408

Term of Deposit

A deposit made before or during pendency of an application for patent shall be made for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposit was received by the depository. This satisfies the terms of the Budapest Treaty

2409

Viability of Deposit

Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. No evidence is necessarily required regarding the ability of the deposited material to perform any function described in the patent application.

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

Once a rejection under 35 U.S.C. 112 has been made by the examiner directed to the absence of access to a biological material, applicant may reply, pursuant to 37 CFR 1.809 (b)(1), by either making an acceptable original or replacement deposit in accordance with these regulations, or assuring the Office in writing that an acceptable deposit will be made on or before the date of payment of the issue fee, or by submitting an argument of why a deposit is not required under the circumstances of the application being considered. Other replies to such a rejection by the examiner shall be considered nonresponsive and may result in abandonment of the application. - See more at: http://www.wikilawschool.net/wiki/MPEP_2400#sthash.r1onQWb8.dpuf

2411.03

Application in Condition for Allowance Except for Deposit

As set forth in 37 CFR 1.809(c), in the event that an application for patent is otherwise in condition for allowance except for a required deposit and the Office has received a written assurance that an acceptable deposit will be made, applicant will be notified and given a period of time within which the deposit must be made in order to avoid abandonment of the application for failure to prosecute the application under 35 U.S.C. 133

2411.04

After Patent Has Been Granted

2411.05

Content of Application with Respect to Deposited Material

2420

The Requirement for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures-the Sequence

2421

Overview of the Sequence Rules

2421.01

Application Affected

The sequence rules require the use of standard symbols and a standard format for sequence data in most sequence-type patent applications. They further require the submission of that data in computer readable form. Compliance is required for most disclosures of sequence data in new applications filed on or after October 1, 1990.

2421.02

Summary of the Requirement of the Sequence Rules

2421.03

Notification of a Failure to Comply

2421.04

Future Changes to the Sequence Rules

2422

Nucleotide and/or Amino Acid Sequence Disclosures in Patent Disclosure in Patent Applications

2422.01

Definitions of Nucleotide and/or Amino Acids for Purpose of Sequence Rules

2422.02

The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures

2422.03

The Requirements for a Sequence Listing and Sequence Identifiers; Sequence Embeded in Application Text; Variants of a Presented Sequence

2422.04

The Requirement for a Computer Readable Copy of the Offical Copy of the Sequence Listing

2422.05

Reference to Previously Filed Identical Computer Readable Form; Continuing or Dericatiove Applications; Request for Transfer of Computer Readable Form

2422.06

Requirement for Statement Regarding Content of Official and Computer Readable Copies of Sequence Listing

2422.07

Requirements for Compliance, Statements Regarding New Matter, and Sanctions for Failure to Comply

2422.08

Presumption Regarding Compliance

2422.09

Box Sequence; Hand Delivery of Sequence Listings and Computer Readable Forms

2423

Symbols and Format to be used for Nuclueotide and/or Amino Acid Sequence Data

2424

Requirements for Nucleotide and/or Amino Acid Sequences as Part of the Application Papers

2424.01

Informational Requirements for the Sequence Listing

2424.02

Sequence Listing Numeric Identifiers

2424.03

Additional Miscellaneous Requirements

2425

Form and Format for Nucleotide and/or Amino Acid Sequence Submissions in Computer Readable Form

2426

Amendments to or Replacement of Sequence Listing and Computer Readable Copy Thereof

2427

Form Paragraphs and Notice to Comply

2427.01

Form Paragraphs

2427.02

Notice to Comply

2434

Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences

Nucleotide sequences encoding different proteins are structurally distinct chemical compounds and are unrelated to one another. These sequences are thus deemed to normally constitute independent and distinct inventions within the meaning of 35 U.S.C. 121. Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement pursuant to 35 U.S.C. 121 and 37 CFR 1.141.

applicants may petition pursuant to 37 CFR 1.181 for examination of additional nucleotide sequences by providing evidence that the different nucleotide sequences do not cover independent and distinct inventions.

2435

Publishing of Patents and Patent Application Publications With Lengthy Sequence Listings

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