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2404.03 Reference to a Deposit in the Specification - 2400 Biotechnology


2404.03 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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