37 CFR 1.807 - Viability of deposit.

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§ 1.807 Viability of deposit.

(a) A deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term 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.

(b) A viability statement for each deposit of a biological material defined in paragraph (a) of this section not made under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:

(1) The name and address of the depository;

(2) The name and address of the depositor;

(3) The date of deposit;

(4) The identity of the deposit and the accession number given by the depository;

(5) The date of the viability test;

(6) The procedures used to obtain a sample if the test is not done by the depository; and

(7) A statement that the deposit is capable of reproduction.

(c) If a viability test indicates that the deposit is not viable upon receipt, or the examiner cannot, for scientific or other valid reasons, accept the statement of viability received from the applicant, the examiner shall proceed as if no deposit has been made. The examiner will accept the conclusion set forth in a viability statement issued by a depository recognized under § 1.803(a).

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code
U.S. Code: Title 35 - PATENTS

Title 37 published on 2014-07-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 37 CFR Part 1 after this date.

  • 2015-10-27; vol. 80 # 207 - Tuesday, October 27, 2015
    1. 80 FR 65649 - Changes To Facilitate Applicant's Authorization of Access to Unpublished U.S. Patent Applications by Foreign Intellectual Property Offices
      GPO FDSys XML | Text
      DEPARTMENT OF COMMERCE, Patent and Trademark Office
      Final rule.
      Effective Date: The changes in this final rule are effective on November 30, 2015. The revised ADS form (PTO/AIA/14) will be posted on the Office's Web site on or before the effective date. Applicability Date: The changes to 37 CFR 1.14(h) apply to all patent applications filed before November 30, 2015, and to all patent applications filed on or after November 30, 2015.
      37 CFR Part 1