Appeal No. 1996-3409
Application No. 08/092,543
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 4 through 7 and 16 through 19 of the Answer,
and appellant’s argument on pages 19 through 21 of the Brief and page 4 of the Reply
Brief. We are persuaded that the specification provides adequate guidance enabling any
person skilled in the art to generate frequency distribution databases and to diagnose
disorders in addition to those of the working examples; and that the experimentation
necessary to practice the full scope of the claimed invention, while
considerable, would not be undue. We hold that the examiner has not set forth a
reasonable basis for questioning the enablement of the claims on appeal; accordingly, the
rejection of claims 1 through 20 under 35 U.S.C. § 112, first paragraph, is reversed.
Indefiniteness
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