Appeal No. 1997-3122
Application No. 08/082,848
[T]he question of undue experimentation is a matter of degree. The fact that
some experimentation is necessary does not preclude enablement; what is
required is that the amount of experimentation “must not be unduly
extensive.” Atlas Powder Co. v. E.I. DuPont de Nemours & Co., 750 F.2d
1569, 1576, 224 USPQ 409, 413 (Fed. Cir. 1984). The Patent and
Trademark Office Board of Appeals summarized the point well when it
stated:
The test is not merely quantitative, since a considerable
amount of experimentation is permissible, if it is merely
routine, or if the specification in question provides a
reasonable amount of guidance with respect to the direction in
which the experimentation should proceed to enable the
determination of how to practice a desired embodiment of the
invention claimed.
Ex parte Jackson, 217 USPQ 804, 807 (1982).
In our view, the evidence of record supports appellants’ conclusion that “[t]he
experimentation required to determine drugs other than FK-506 and cyclosporin with which
to practice the [claimed] method . . . is routine and is not undue” and “the specification
provides a reasonable amount of guidance as to how this experimentation should
proceed.” Brief, pages 6 and 7.
6
The examiner additionally relies on Sharkey, a reference published after the filing
date of the present application, to establish “doubt as to the objective truth of appellant[s’]
assertion of predictability.” Examiner’s Answer, page 9. Nevertheless, on balance, we
find that Sharkey’s teachings weaken, rather than reinforce, the examiner’s position.
6Sharkey & Butcher (Sharkey), “Immunophilins Mediate the Neuroprotective Effects
of FK506 in Focal Cerebral Ischaemia,” Nature, Vol. 371, pp. 336-339 (September 22,
1994).
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