Appeal No. 2001-0869 Page 8
Application No. 08/453,347
First, a therapeutic method need not be ready for clinical application in
order to be enabled. See In re Brana, 51 F.3d 1560, 1567, 34 USPQ2d 1436,
1442 (Fed. Cir. 1995): “Usefulness in patent law, and in particular in the context
of pharmaceutical inventions, necessarily includes the expectation of further
research and development. The stage at which an invention in this field
becomes useful is well before it is ready to be administered to humans.”2 The
Brana court noted that the CCPA has held that “proof of an alleged
pharmaceutical property for a compound by statistically significant tests with
standard experimental animals is sufficient to establish utility.” Id. at 1567, 34
USPQ2d at 1442 (citing In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219
(CCPA 1961)). The instant specification provides an example of tumor
suppression in an animal model. See pages 9-10 and Figures 2A and 2B.
Again, at the risk of being repetitive, evidence that a claimed method was
not ready for clinical application is not enough to show nonenablement. What is
needed is evidence or sound scientific reasoning that undue experimentation
would have been required to carry out the claimed methods. The claims are
variously directed to methods of “suppressing tumor formation, ”increasing
monocyte mediated tumoricidal activity,” “treating a localized side-effect of
malignancy,” or “combatting a parasitic infection,” and therefore imply some
degree of therapeutically beneficial effect. That standard, however, is more
lenient than the standards by which clinical trials are judged. See, e.g., Brana,
2 Although the Brana court referred to “usefulness,” the rejection on appeal was based on 35
U.S.C. § 112, first paragraph. See 51 F.3d at 1564, 34 USPQ2d at 1439.
Page: Previous 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Next
Last modified: November 3, 2007