[Code of Federal Regulations]
[Title 37, Volume 1]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 37CFR1.807]

[Page 195-196]
 
              TITLE 37--PATENTS, TRADEMARKS, AND COPYRIGHTS
 
                         DEPARTMENT OF COMMERCE
 
PART 1--RULES OF PRACTICE IN PATENT CASES--Table of Contents
 
             Subpart G--Biotechnology Invention Disclosures
 
Sec. 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.

[[Page 196]]

    (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 Sec. 1.803(a).