Appeal No. 2004-0291
Application No. 09/091,561
It is the examiner’s position that (Answer, pages 3-4):
The specification disclosure is insufficient to enable one skilled in the art to
practice the invention claimed without undue experimentation because if
one of skill in the art performed the method disclosed in the specification
said method would not result in the product of the present claims.
The method set forth in the specification would result in a polyclonal
antiserum. It is clear however, that only a monoclonal antibody can
function in the intended capacity of the antibody of the instant claims. A
polyclonal antiserum... would be expected to comprise a mixture of
antibodies, some would bind flk-1, some would bind flt, and some would
bind both... This concept is demonstrated in Inventor Plouet’s declaration
filed 9/11/00, which indicates that in one experiment 3 of 4 monoclonal
antibodies produced after a polyclonal response were not specific for flk-
1...
More specifically, the examiner argues that because “the specification is deficient
in disclosing how to make the antibody of the independent claims, it is also deficient in
disclosing how to make the Fab fragment of the claims because the Fab fragment is
merely an enzymatic cleavage product of the antibody.” Answer, page 7. The examiner
also appears to be concerned that the methods of purification outlined in the
specification would not isolate the selective antibodies claimed.
Appellants respond, arguing (Brief, pages 7-8)
[W]hile the present specification describes the production of the claimed
antibodies in a purified polyclonal fraction, the claimed antibody is
indisputably present in the polyclonal antiserum described in the present
specification.
...[T]he evidence of record further demonstrates that it would be a
matter of routine experimentation to further isolate and purify the claimed
antibody, as well as to produce monoclonal antibodies using conventional
techniques...
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