Appeal No. 1996-2468
Application 08/091,899
prostaglandin inhibition. This showing is uncontroverted by the examiner. Thus, it would
reasonably appear that the “how to use” requirement of 35 U.S.C. § 112, first paragraph is
satisfied by the above disclosure.
In vitro results with respect to the particular pharmacological activity are generally
predictive of in vivo test results, i.e., there is a reasonable correlation therebetween. Were
this not so, the testing procedures of the pharmaceutical industry would not be as they are.
It is not urged, that there is an invariable exact correlation between in vitro test results and
in vivo test results. Cross v. Iizuka, 753 F.2d 1040, 1044, 224 USPQ 739, 742 (Fed. Cir.
1985); Nelson v. Bowler, 626 F.2d 853, 856,
206 USPQ 881, 883 (1980). It is appellant's position that successful in vitro testing for a
particular pharmacological activity establishes a significant probability that in vivo testing
for this particular pharmacological activity will be successful. On the facts before us, we
agree.
Based upon the relevant evidence as a whole, we find there to be a reasonable
correlation between the disclosed in vitro utility and an in vivo activity, and therefore a
rigorous correlation is not necessary where the disclosure of pharmacological activity is
reasonable based upon the probative evidence. Cross v. Iizuka, supra; Nelson v. Bowler,
supra.
REJECTIONS UNDER 35 U.S.C. § 112, SECOND AND FOURTH PARAGRAPHS
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