Appeal No. 1998-2195
Application No. 08/277,241
determine what range of DIP levels are normal, and what (elevated) levels
correlate to inhibition of hCG production and consequent risk in pregnancy.
However, the examiner has conceded that the specification provides a
bioassay to measure DIP and that DIP inhibits hCG production. Answer, page 4.
We also note that Appellants have previously been granted a patent on DIP itself,
the claim defining DIP in part by its dose-dependent inhibition of hCG. See claim
1 of U.S. Patent 5,140,100.1
Based on these uncontested facts, a person of ordinary skill in the art
would reasonably expect that a higher level of DIP would generally correlate to a
lower level of hCG. Appellants have submitted evidence that diagnostic tests for
other hormones are based on similar relationships with those hormones’ effector
substances. See Noe et al., The Logic of Laboratory Medicine (1985), pages
158-162, cited in Appellants’ Brief. Thus, based on the evidence that similar
assays are accepted in the art as diagnostic and the high level of skill in the art,
we conclude that determining of the normal range of DIP levels would not have
required more than routine experimentation.
“Enablement . . . is not precluded even if some experimentation is
necessary, although the amount of experimentation needed must not be unduly
extensive.” Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384,
231 USPQ 81, 94 (Fed. Cir. 1987) (citations omitted). “The key word is ‘undue,’
1 Claim 1 of the ‘100 patent reads: “A substance having an inhibitory effect on the production of
human chorionic gonadotropin (hCG) comprising a regulatory polypeptide being characterized in
that it: (a) inhibits, in a dose dependent manner, the production of hCG by human trophoblasts in
vitro . . .”.
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