Appeal No. 2001-1970 Page 11
Application No. 08/260,190
variously directed to methods of “treating neoplastic disease and/or pre-
neoplastic disease”, “inhibiting growth of a vertebrate cancer cell”, or “inhibiting
the expression of a MN gene.” Thus, the claims at least encompass methods
that require some degree of therapeutically beneficial effect. That standard,
however, is more lenient than what is required for clinical application. See, e.g.,
Brana, 51 F.3d at 1568, 34 USPQ2d at 1442 (“On the basis of animal studies,
and controlled testing in a limited number of humans (referred to as Phase I
testing), the Food and Drug Administration may authorize Phase II clinical
trials. . . . Authorization for a Phase II study means that the drug may be
administered to a larger number of humans, but still under strictly supervised
conditions. The purpose of the Phase II study is to determine primarily the safety
of the drug . . . as well as its potential efficacy under different dosage
regimens.”).
In this case, we have no fact-based explanation from the examiner
focused on the claimed methods, as opposed to antisense therapy as a general
field, to establish that the instant claims are nonenabled. In addition, it is well-
established that the amount of experimentation that is considered “undue” varies
from one field to another. See, e.g., Wands, 858 F.2d at 737, 8 USPQ2d at 1404
(factors relating to undue experimentation include quantity of experimentation
necessary, nature of the invention, and relative skill of those in the art).
filing date. Cf. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1346, 54 USPQ2d 1915, 1917-18 (Fed.
Cir. 2000).
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