37 CFR 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.
Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1957 (2001)(explaining how deposit may help satisfy enablement requirement); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 63 USPQ2d 1609 (Fed. Cir. 2002)(deposit may satisfy the written description requirement); In re Argoudelis, 434 F.2d 666, 168 USPQ 99 (CCPA 1970). To facilitate the recognition of deposited biological material in patent applications throughout the world, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was established in 1977, and became operational in 1981. The Treaty requires signatory countries, like the United States, to recognize a deposit with any depository which has been approved by the World Intellectual Property Organization (WIPO).
The deposit rules (37 CFR 1.801 – 1.809) set forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required. The rules do not address the substantive issue of whether a deposit is required under any particular set of facts.