Appeal No. 1995-2723
Application 07/858,747
a few embodiments and do not demonstrate with reasonable specificity how to
make and use the other potential embodiments across the full scope of the
claims. See, e.g. In re Goodman, 11 F.3d 1046, 1050-52, 29 USPQ2d 2010, 2013-
2015 (Fed. Cir. 1993); Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200,
1212-14, 18 USPQ2d 1016, 1026-28 (Fed. Cir.),
cert. denied, 502 U.S. 856 (1991); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d
1438, 1445. Enablement is lacking in those cases, the court has explained,
because the undescribed embodiments cannot be made based on the
disclosure in the specification, without undue experimentation. But the 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 (Bd. App. 1982).
In addition, the examiner should consider whether "the level of expression of said
gene" would reasonably serve as a means of evaluating whether the effect of the INS
within the coding region of the mRNA has been reduced. Both Schwartz and Wisdom
would appear to suggest that the level of transcription of the mRNA would not necessarily
reflect the "post transcription effect" called for by the claims.
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