Appeal No. 1998-1987
Application No. 07/915,783
an art-accepted experimental animal for malaria vaccine research. See Perrin,
pages 1345 and 1346 (discussing immunization of mice with various plasmodial
antigens); Butcher, page 318 (showing the results of three vaccination trials
conducted in mice, together with results from other animals) and 321-22
(discussing the advantages and disadvantages of various animal models,
including mice).
Thus, the specification appears to provide “proof of an alleged
pharmaceutical property for a compound by statistically significant tests with
standard experimental animals.” Brana, 51 F.3d at 1567, 34 USPQ2d at 1442.
This “is sufficient to establish utility,” id., unless the examiner provides convincing
evidence or scientific reasoning to the contrary. The examiner, however,
provides only vague doubts about whether the claimed compositions will
ultimately prove to be effective. On this record, we cannot say that the claims
lack utility and we therefore reverse the rejection of claims 11-16, 18, 27, 29, and
68-80 for nonenablement.
3. The “undue experimentation” enablement rejection.
In a separate rejection, the examiner rejected all of the pending claims as
nonenabled, on the basis that undue experimentation would be required to
practice the claims throughout their full scope. The examiner points to Howard
as showing that different detergents extract different antigens from malarial
parasites. The examiner concludes that “the disclosure is enabling only for
claims limited to antigenic factors obtained using the exemplified non-ionic
detergents.” Examiner’s Answer, page 9.
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