Appeal No. 1997-0473
Application No. 07/870,985
the isolation of ET-NANBH, a.k.a., HEV or Hepatitis E Virus, as well as the
development of experimental animals which are known to develop sera
against the virus. . . [and notes] that antibodies which had been raised in
both humans and in the primate models, in response to an ET-NANBH
(HEV) infection, was purified.
The examiner concludes that (Answer, page 11):
one of ordinary skill in the art at the time of the invention was made would
have clearly been motivated to have utilized the sera produced by the
monkeys taught by Bradley et alii, [sic] for a passive immunotherapy as
disclosed by Cohen. Give [sic, Given] that Cohen teaches the development
and use of passive therapy for a number of virally caused disease, including
two types of hepatitis, the ordinary skilled artisan would have had a
reasonable expectation of success.
It is sufficient for the purposes of this appeal to note that neither Bradley or Cohen
describes, suggests or speculates on the possibility of developing a vaccine for HEV
using antibodies capable of neutralizing HEV infection as required by the claims on
appeal. As stated by appellants (Brief, paragraph bridging pages 8-9):
Bradley, et al., do not teach any characterized sera, much less any specific
epitopes of HEV, sequences or methods of identifying epitopes capable of
generating neutralizing antibodies. And of course, Bradley, et al, do not
teach that an antibody which is immunoreactive with a peptide containing the
C-terminal 48 amino acids of the capsid protein encoded by the second
open reading frame of the HEV genome is effective at neutralizing HEV or
preventing HEV infection.
The examiner has not provided any evidence which would reasonably link the
antibody vaccines described by Cohen with the sera generated antibodies of Bradley. In
the absence of such evidence, the only suggestion to formulate a composition for the
treatment and prevention of HEV infection in an individual, such as claimed in claim 15, is
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