Deposit of Biological 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

. 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

n

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 locus, 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.