2403 Deposit of Biological Material
37 C.F.R. 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.
37 CFR 1.801 indicates that the rules pertaining to deposits for purposes of patents for inventions under 35 U.S.C. 101 are intended to relate to biological material. For the purposes of these rules, the term “biological material” is defined in terms of a non-exhaustive list of representative materials which can be deposited in accordance with the procedures defined in these rules. These rules are intended to address procedural matters in the deposit of biological material for patent purposes. They are not designed to decide substantive issues such as whether a deposit of a particular organism or material would be recognized or necessary for the purposes of satisfying the statutory requirements for patentability under 35 U.S.C. 112. Although the issue of the need to make a deposit of biological material typically arises under the enablement requirement of the first paragraph of 35 U.S.C. 112, the issue could also arise under the description requirement (35 U.S.C. 112, first paragraph), best mode requirement (35 U.S.C. 112, first paragraph) or the requirements of the second paragraph of 35 U.S.C. 112 with respect to the claims.
37 CFR 1.801 does not attempt to identify what biological material either needs to be or may be deposited to comply with the requirements of 35 U.S.C. 112. For the most part, this issue must be addressed on a case-by-case basis. Thus, while the Office does not currently contemplate that there would be any situations where a material that is not capable of self-replication either directly or indirectly would be acceptable as a deposit, an applicant is clearly not precluded by these rules from attempting to show in any given application why the deposit of such a material should be acceptable to satisfy the requirements of 35 U.S.C. 112.
2403.01 Material Capable of Self- Replication
Biological material includes material that is capable of self-replication either directly or indirectly. Direct self-replication includes those situations where the biological material reproduces by itself. Representative examples of materials capable of self-replication are defined in the rule. Indirect self-replication is meant to include those situations where the biological material is only capable of replication when another self-replicating biological material is present. Self-replication after insertion in a host is one example of indirect self-replication. Examples of indirect replicating biological materials include viruses, phages, plasmids, symbionts, and replication defective cells. The list of representative examples of each type of replicating material includes viruses to demonstrate that the two lists in the rule are not intended to be mutually exclusive.
2403.02 Plant Material
Although plant material is included within the scope of the definition of biological material for purposes of patents for plant inventions under 35 U.S.C. 101, the rules on deposits are not applicable to applications filed under the Plant Patent Act (35 U.S.C. 161-164). The Office is of the view that a deposit is not required under the present provisions of 35 U.S.C. 162. Thus, a deposit is not necessary for the grant of a plant patent under the provisions of 35 U.S.C. 161-164. As with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112.
As with some types of reproducible biological material, seeds can be reproduced only after a growing season which may be relatively long. Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, the Office will consider 2500 to be a minimum number in the normal case, but will give an applicant the opportunity to provide justification why a lesser number would be suitable under the circumstances of a particular case. The Department of Agriculture requires a deposit of 2500 seeds for the grant of a Plant Variety Protection Certificate under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.). As the reproduction of seeds will often take a substantial period of time, the Office will require, at a minimum for the grant of a patent, a number of seeds that is likely to satisfy demand for samples once the patent is granted. In one instance, the Office accepted a deposit of 600 seeds coupled with an undertaking to deposit 1900 more seeds with due diligence. The particular situation involved a “seedless” vegetable with very few seeds per “fruit;” about two growing seasons were required to provide the additional 1900 seeds.