Appeal No. 1999-1413
Application 08/176,024
buffered saline (PBS) which is considered to be a pharmaceutically acceptable diluent for
storage of antibodies.
The examiner summarizes (Answer, pages 5-6),
It would have been obvious for one of ordinary skill in the art to
produce solutions consisting of NVS3 monoclonal antibody as taught by
McCutchan et al references. One of ordinary skill in the art would have been
motivated to produce such compositions in order to form stable storage
compositions, or working solutions for us in assays, etc. The antibody
concentrations in such compositions would have been those which would be
considered to be pharmaceutical amounts, and solutions comprising the
NVS3 antibody PBS would be considered to be pharmaceutically injectable
solutions given that the buffer PBS is a pharmaceutically acceptable diluent.
Even though the appellants characterize the claimed formulations as being
for use in passive protection against P.vivax, the claims read on the
ingredients per se, which in the case of the instant claims are NVS3
antibody in a pharmaceutically acceptable carrier.
Appellants argue in response to this rejection that, at best the examiner has argued
that it would be obvious to try using the NVS3 monoclonal antibody for passive
immunization and that it would have some protective activity. Substitute Brief, page 24.
Appellants argue the examiner has failed to provide evidence to support a reasonable
expectation of the success of passive immunization using the monoclonal antibody, as
claimed. Id. Furthermore, appellants argue that Harlow teaches away from the invention
by recommending addition of sodium azide, a poison, as a preservative in monoclonal
antibody solutions. Substitute Brief, page 32.
We agree with appellants that the examiner has failed to establish a prima facie
case of obviousness on the record before us. McCutchan teaches the claimed monoclonal
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