Reference to a Deposit in the Specification

37 CFR

1.802(c)

specifically provides that the mere reference to a

biological material in the specification disclosure or the actual deposit of such

material does not create any presumption that such referenced or deposited material is

necessary to satisfy

35 U.S.C. 112

, or that a deposit in accordance with these

regulations is or was required. It should be noted, however, that a reference to a

biological material, present in an application upon filing, may form the basis for

making a deposit, where required, after the filing date of a given application but that

the reference to the biological material, itself, cannot be added after filing without

risking the prohibited introduction of new matter (

35 U.S.C. 132

). See the discussion

of the Lundak application in

MPEP § 2406.01

.

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