Appeal No. 1995-3257
Application 08/056,382
results were presented from the human trials, it cannot be established
that the results obtained with immature rats were predictive of efficacy
in human [sic, humans], and it is deemed that the model system was not
adequately validated but that the art recognized the potential
[examiner's emphasis] utility of the model system. It is not predictable
that the results presented in the current specification as filed would
be successfully applied to the proposed methods of treatment; to
investigate such and determine the appropriate/optimal methods of
administration and dosage levels for human subjects [examiner's
emphasis] is deemed to constitute undue experimentation in the absence
of any information as to the efficacy in humans, or alternatively any
data generated using an acceptable model system.
Appellants method claims are directed to treating animals, including human, however
enablement of the current specification as filed is commensurate in scope only with the use of
the claimed methods in mice." Examiner's Answer, pp. 4-6.
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