Need or Opportunity to Make a Deposit

37 CFR 1.802  Need or opportunity to make a deposit.

(a) Where an invention is, or relies on, a biological material, the

disclosure may include reference to a deposit of such biological material.

(b) Biological material need not be deposited unless access to such

material is necessary for the satisfaction of the statutory requirements for

patentability under

35 U.S.C. 112

. If a deposit is

necessary, it shall be acceptable if made in accordance with these regulations.

Biological material need not be deposited,

inter alia,

if it is

known and readily available to the public or can be made or isolated without undue

experimentation. Once deposited in a depository complying with these regulations,

a biological material will be considered to be readily available even though some

requirement of law or regulation of the United States or of the country in which

the depository institution is located permits access to the material only under

conditions imposed for safety, public health or similar reasons.

(c) The reference to a biological material in a specification

disclosure or the actual deposit of such material by an applicant or patent owner

does not create any presumption that such material is necessary to satisfy

35 U.S.C.

112

or that deposit in accordance with these regulations is

or was required.

37 CFR

1.802(a)

permits a deposit of a biological material to be referenced

in a patent application where an invention is, or relies on, a biological material. The

invention may rely on a biological material for the purposes of making or using the

invention, either as a preferred mode or an alternative mode of operation. A reference to a

deposit may be included in a specification even though the deposit is not required to

satisfy the requirements of

35 U.S.C. 112

.

There is no necessary implication or presumption that can or should be

made about the need for a deposit simply because reference to a deposit is made in an

application disclosure, as noted in paragraph (c)

rred mode or an alternative mode of operation. A reference to a

deposit may be included in a specification even though the deposit is not required to

satisfy the requirements of

35 U.S.C. 112

.

There is no necessary implication or presumption that can or should be

made about the need for a deposit simply because reference to a deposit is made in an

application disclosure, as noted in paragraph (c). As noted in paragraph (b), biological

material need not be deposited unless access to such material is necessary for the

satisfaction of the statutory requirements for patentability under

35 U.S.C. 112

and

that access is not otherwise available in the absence of a deposit. Where a deposit is

required to provide the necessary access, a deposit is acceptable for patent purposes only

where it is made in accordance with these regulations. Even where access to biological

material is required to satisfy these statutory requirements, a deposit may not be

necessary if access sufficient to satisfy these requirements is otherwise available.