2403 Deposit of Biological Material [R-07.2015]
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. The issue of the need to make a deposit of biological material typically arises under 35 U.S.C. 112(a) with regard to the enablement requirement, although the issue may also arise under the written description or best mode requirement of the statute. Deposit issues may also arise under 35 U.S.C. 112(b) 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. The examiner is cautioned against requiring that a specific biological material be deposited where the applicant can show that a deposit of starting material that is currently not available to the public would allow the skilled artisan to make and use the claimed invention. For example, where a claimed invention is drawn to a plant having novel properties produced by the insertion of a proprietary gene at a specific loci, the plant per se need not be deposited if deposit of a vector or hybridoma containing the gene would enable one of ordinary skill in the art to make and use the claimed invention without undue experimentation.