Appeal No. 1996-2538
Application 08/097,869
In the Examiner’s Answer (Paper No. 31, April 5, 1995), the examiner states on
page 4 that “it would require undue experimentation for one of ordinary skill in the art to
make the hybrid cytokines such that the hybrid cytokines possess a desired activity and
can be used in a beneficial manner. Each hybrid cytokine would have to be tested for all of
the activities attributed to each native cytokine from which it is derived, as well as for any
'unique' property.” Again, in making this statement, it does not appear that the examiner
has taken into consideration the proper legal standards concerning issues of enablement
under 35 U.S.C. § 112, first paragraph, in that the examiner has not presented a fact-
based analysis concerning how and why any experimentation needed to practice the
invention would be “undue.” As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75
F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996),
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).
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