Appeal No. 1998-1987
Application No. 07/915,783
See the Examiner’s Answer, pages 6-8. The examiner acknowledges that “[t]he
specification sets forth data showing immunization of mice with recovered blood
stage antigens from P. berghi.” Id., page 6. However, she concludes that these
data are insufficient to enable the claims because later-published references
(Butcher and Mitchell) show that malaria vaccines were still an elusive goal as
late as 1989. The examiner also cites these references for their statements that
“with the exception of the work carried out in man, the validity of all experimental
systems is open to challenge” (Mitchell), and “any [animal] model of malaria has
some difficulties” (Butcher). She concludes that
Applicant[’]s claims must be assessed at the time of filing, and the
teachings of Mitchell and Butcher indicate that there is no malaria
vaccine per se, or one which effectively causes “resistance” to the
malaria parasite, and that extrapolation from murine data, to similar
efficacy in all animals, particularly humans[,] cannot be done.
Examiner’s Answer, page 8.
The examiner’s statement of the rejection makes clear that the instant
rejection, although framed as nonenablement, is actually based on lack of an
adequate disclosed utility for the claimed compositions. That is, the examiner
finds the specification’s data to be unconvincing of therapeutic efficacy and
therefore concludes that the specification does not adequately teach how to use
the claimed compositions. We disagree.
The examiner bears the initial burden of showing nonenablement or lack
of utility. See In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA
1971) (“[A] specification disclosure which contains a teaching of the manner and
process of making and using the invention in terms which correspond in scope to
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