Appeal No. 1999-1245
Application No. 08/245,282
can be predictive of in vivo test results, if 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,
224 USPQ 739 (Fed. Cir. 1985); Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ
881 (1980).
Although not explicitly stated in section 112, to be enabling, the specification of a
patent must teach those skilled in the art how to make and use the full scope of the
claimed invention without "undue experimentation." In re Vaeck, 947 F.2d 488, 495, 20
USPQ2d 1438, 1444 (Fed. Cir. 1991); In re Wands, 858 F.2d 731, 737, 8 USPQ2d
1400, 1404, (Fed. Cir. 1988); In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24
(CCPA 1970) (the first paragraph of section 112 requires that the scope of protection
sought in a claim bear a reasonable correlation to the scope of enablement provided by
the specification). Nothing more than objective enablement is required, and therefore it
is irrelevant whether this teaching is provided through broad terminology or illustrative
examples. In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA 1971).
In our view, the examiner’s analysis of the Wands factors on the record before
us is incomplete and has focused almost exclusively on, and given undue weight to,
statements of unpredictability in the art, to support the inability of the in vitro model
proposed by appellant to be correlated to in vivo results. It would appear that the
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