37 CFR § 1.802 — Need or opportunity to make a (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.802 Need or opportunity to make a
Source: Patent Rule (37 CFR)BlueIron Update:
This page consolidates MPEP guidance interpreting 37 CFR § 1.802, including 24 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 outlines the need or opportunity to make a deposit of biological materials in a patent application, ensuring compliance with 37 CFR regulations and providing necessary access.
What this section covers
- The section covers the need or opportunity to make a deposit of biological materials in a patent application where an invention relies on such materials.
- It also addresses the conditions under which a deposit is required and how it must be made in accordance with 37 CFR regulations.
Key obligations
- Practitioners must make a deposit of biological materials in accordance with 37 CFR regulations if required for the patent application.
- A deposit is not necessary if access sufficient to satisfy statutory requirements is otherwise available.
Practice notes
- Ensure the deposit is made with an organization that meets the necessary criteria for maintaining biological materials.
- Verify that the deposit is made in a timely manner and includes all necessary documentation.
Official MPEP § 1.802 — Need or opportunity to make a
Source: USPTOLast Modified: 10/30/2024 08:50:22
1.802 Need or opportunity to make a deposit.
- (a) Where an invention is, or relies on, a biological material, the disclosure may include reference to a deposit of such biological material.
- (b) Biological material need not be deposited unless access to such material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 . If a deposit is necessary, it shall be acceptable if made in accordance with these regulations. Biological material need not be deposited, inter alia, if it is known and readily avaliable [sic] to the public or can be made or isolated without undue experimentation. Once deposited in a depository complying with these regulations, a biological material will be considered to be readily available even though some requirement of law or regulation of the United States or of the country in which the depository institution is located permits access to the material only under conditions imposed for safety, public health or similar reasons.
- (c) The reference to a biological material in a specification disclosure or the actual deposit of such material by an applicant or patent owner does not create any presumption that such material is necessary to satisfy 35 U.S.C. 112 or that deposit in accordance with these regulations is or was required.
[Added, 54 FR 34880, Aug. 22, 1989, effective Jan. 1, 1990]
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- Budapest Treaty
- Ex Parte Reexamination
- Reexamination Conclusion
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- Filing Date Requirements
- Reissue
- Reissue Concurrent Proceedings
| MPEP Section | Rules |
|---|---|
| MPEP § 2404 | |
| MPEP § 2404.03 | |
| MPEP § 2407 | |
| MPEP § 2407.01 | |
| MPEP § 2411.01 |