37 CFR § 1.807 — Viability of deposit. (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.807 Viability of deposit.
Source: Patent Rule (37 CFR)BlueIron Update:
This page consolidates MPEP guidance interpreting 37 CFR § 1.807, including 17 rules from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Summary
This section addresses the requirements for ensuring the viability of biological material deposits not made under the Budapest Treaty, including the need for a detailed viability statement.
What this section covers
- Defines that this section addresses the viability statement required for deposits not made under the Budapest Treaty.
Key obligations
- Practitioners must include a viability statement for each deposit not made under the Budapest Treaty.
- The viability statement must be provided for biological materials defined in paragraph (a) of this section.
Practice notes
- Advise practitioners to ensure the viability statement is specific and detailed, addressing any potential issues that may arise with the deposit.
- Warn practitioners against making assumptions about viability without clear evidence, as this can lead to compliance issues.
Official MPEP § 1.807 — Viability of deposit.
Source: USPTOLast Modified: 10/30/2024 08:50:22
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) .
[Added, 54 FR 34882, Aug. 22, 1989, effective Jan. 1, 1990]
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- Budapest Treaty
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| MPEP Section | Rules |
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| MPEP § 2409 |