37 CFR § 1.801 — Biological material. (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.801 Biological material.
This page consolidates MPEP guidance interpreting 37 CFR § 1.801, including 50 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 provides guidelines for ensuring a written description of the claimed invention with all its limitations, particularly focusing on biological materials, including their deposit requirements.
What this section covers
- Defines what this section covers at a high level, including biological materials and their deposit requirements.
- Identifies the core topic and scope of guidance in this section, focusing on ensuring written description for biological materials.
Key obligations
- Ensures a written description of the claimed invention, including all its limitations.
- Requires deposit under the Budapest Treaty for certain biological materials to facilitate international recognition of deposited material.
Practice notes
- Ensures clear and complete disclosure of biological materials in the application.
- Highlights the importance of timely deposit and proper reference in the application for biological materials.
Official MPEP § 1.801 — Biological material.
Source: USPTOLast Modified: 10/30/2024 08:50:22
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.
[Added, 54 FR 34880, Aug. 22, 1989, effective Jan. 1, 1990]
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| MPEP Section | Rules |
|---|---|
| MPEP § 2163 | |
| MPEP § 2401 | |
| MPEP § 2402 | |
| MPEP § 2403 | |
| MPEP § 2403.02 |