Appeal No. 1996-3409
Application No. 08/092,543
known as is encompassed by the instant claims . . ”). See the Examiner’s Answer, pages
4 and 5.
The examiner is further concerned with the absence of certain specific information
(“[t]he specification fails to identify the method used to classify the samples into control and
disease groups . . . [t]he specification fails to teach what level of agreement between a test
individual and a particular disease is required before a classification or diagnosis of a
disease state can be made”). See the Examiner’s Answer, pages 6 and 7.
The claims are indeed broad, and generating a frequency distribution data base for
diseases and/or biological samples encompassed by the claims, but not 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):
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