Appeal 2007-1152
Application 10/660,924
there being always a degree of uncertainty about whether the treatment will
prove to be effective in humans. In our opinion, this is not a reasonable
standard by which to measure enablement.
The publications cited by the Examiner acknowledge that there are
weaknesses in available mouse models as surrogates for human disease, but
these same publications continue to use the animal models to study human
disease because the animal models are apparently “‘as good as it gets’, short
of a study in humans” (Atkinson, at 601).
In cases where the utility of claimed compounds were questioned, the
Federal Circuit has repeatedly held that in vitro and animal tests, when
reasonably correlated with the in vivo activity asserted as the utility, were
sufficient to satisfy the utility requirement of 35 U.S.C. § 101. Cross v.
Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747 (Fed. Cir. 1985). In In re
Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995), the PTO had
argued that mouse data was insufficient to establish utility for a cancer
treatment drug. In rejecting this position, the Federal Circuit wrote:
The Commissioner counters that such in vivo tests in animals
are only preclinical tests to determine whether a compound is
suitable for processing in the second stage of testing, by which
he apparently means in vivo testing in humans, and therefore
are not reasonably predictive of the success of the claimed
compounds for treating cancer in humans. The Commissioner,
as did the Board, confuses the requirements under the law for
obtaining a patent with the requirements for obtaining
government approval to market a particular drug for human
consumption. See Scott v. Finney, 34 F.3d 1058, 1063, 32
literature is littered with the examples of therapies that work well in mice
but fail to provide similar efficacy in humans[’] [Mestas, at 271] (emphasis
added)” (Answer 5).
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