Appeal No. 1997-3275
Application No. 07/963,329
Here, the examiner has not explained why one skilled in this art would not be able to
determine the appropriate dose of the claim designated IGF-1 to administer to a mammal
given the guidance provided at pages 29 - 30 of the specification. As the examiner has
acknowledged (Answer, page 4) "[t]he relative skill of those in the art of neurological
treatments is commonly recognized as being high." The examiner has offered no
evidence which would reasonably establish that one of "high" skill would not have been
able to select and administer the appropriate dose of IGF-1, to a patient in need thereof,
without undue experimentation given the guidance provided by the specification.
As to the arguments concerning the evidence of record, including the declaration of
Dr. Bozyczko-Coyne filed September 14, 1994, and the examiner's conclusion that
appellants have not demonstrated that the administration of IGF-1, as claimed, will result in
promoting the survival of photoreceptors in a mammal, we note simply, that the examiner
has misplaced the "burden" in this aspect of the rejection. The burden is on the examiner
to establish a reasonable basis for questioning whether the claimed method does not
provide the benefit or usefulness disclosed by the applicants. Only when the examiner
meets this burden, does the burden shift to applicants to provide suitable evidence
indicating that the specification is enabling in a manner commensurate in scope with the
protection sought by the claims. In re Marzocchi, supra. That some experimentation may
be necessary, does not equate to undue experimentation. In re Angstadt, 537 F.2d 498,
502-03, 190 USPQ 214, 218 (CCPA 1976). Here, the examiner has failed to establish,
by a preponderance of the evidence, that the disclosure provided in support of the claimed
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