Appeal No. 1999-0326
Application No. 07/997,715
First, the examiner argues “[a]s noted in the Examiner’s Answer mailed 1 March
1996,” that “the design and utilization of anti-sense nucleic acids was a highly
unpredictable art . . . requir[ing] extensive experimentation in the elaboration of appropriate
nucleic acid constructs that when introduced into a host cell would effect an inhibition of
expression of any particular gene or gene product.” Second Supplemental Examiner’s
Answer, page 2. Turning to the Examiner’s Answer, we note that page 576 of Uhlmann is
relied on as evidence of unpredictability. Uhlmann describes a number of variables
affecting “[t]he efficiency with which the function of a target sequence can be inhibited,” but
at the same time, describes several routine approaches to selecting effective target
sequences.
As explained in PPG Indus. Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37
USPQ2d 1618, 1623 (Fed. Cir. 1996) (quoting Ex parte Jackson, 217 USPQ 804, 807
(Bd. App. 1982)), “[t]he fact that some experimentation is necessary does not preclude
enablement . . . [t]he test is not merely quantitative, since a considerable amount of
experimentation is permissible, if it is merely routine . . . ” See also In re Vaeck, 947 F.2d
488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (“That some experimentation may be
required is not fatal; the issue is whether the amount of experimentation required is
‘undue.’” (emphasis in original). While identifying inhibitory nucleic acid constructs other
than pANTI-IGF-I might involve a considerable amount of trial and error, in our view, the
empirical experimentation described by Uhlmann is fairly described as routine.
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