Appeal 2007-1032
Application 10/062,920
against E. canis infection is highly unpredictable” because the proteins’
functions were not known, and because the art does not disclose any
previous methods in which E. canis infection was inhibited (id. at 8).
Thus, the Examiner argues, “the claimed method is not one where a
routine method known in the art is practiced with unknown proteins” (id.).
Instead, because the Specification “and the prior art lack any evidence that
any E. canis proteins could induce an immune response against E. canis in
vivo to effectively treat or protect a subject from infection[,] and lack any
guidance as to how any 28 kDa E. canis proteins are related to infection,”
the Examiner concludes that practicing the claimed method would require
undue experimentation (id. at 9).
Appellants argue that the Examiner has interpreted the claims too
narrowly (Br. 8) and has not made out a prima facie case of lack of
enablement (id. at 6-8). Appellants argue that the Specification meets the
enablement requirement by providing the amino acid sequences for the
proteins, and methods for enhancing their immunogenicity (id. at 9).
Appellants argue that one of the claimed proteins has been demonstrated to
react with antiserum from a dog previously infected with E. canis, and that
“therefore it is not undue to demonstrate that giving the recombinant protein
to an uninfected dog would produce antibodies to the recombinant protein”
(id. at 10). Moreover, Appellants argue, in view of the high skill level in the
immunological arts, the experimentation required to practice the claimed
method would be routine, rather than undue (id. at 11).
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
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