Appeal No. 1996-2240
Application No. 08/105,482
demonstrated by working examples, would undoubtedly be time consuming. Nevertheless,
the test for undue experimentation is not merely quantitative. As stated in PPG Indus., Inc.
v. Guardian Indus. Corp., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996):
[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 this point in Ex parte
Jackson, 217 USPQ 804, 807 (1982):
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.
Moreover, it is well settled that the specification need not disclose what is well
known in the art. Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385, 231
USPQ 81, 94 (Fed. Cir. 1986). The examiner has not presented evidence that
those skilled in the art would be unable to identify control and disease populations from
which to generate frequency distribution data bases.
We have carefully reviewed the specification, including the working examples, in
light of the examiner’s commentary on pages 3 through 6 and 16 through 22 of the Answer.
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