Appeal No. 1996-1002
Application 07/988,945
variation of activity from antibody to antibody. (Id.) The examiner cites Waldmann, Hird
and Harris in support of the position that murine and other animal testing has not
proven readily predictive of effective therapy, in humans, using such monoclonal
antibodies. (Answer, page 6). The examiner concludes that (Answer, paragraph
bridging pages 6-7):
[i]n view of the contemporary knowledge in the art and the general lack of
successful application of monoclonal antibody-based therapy methods for
the treatment of human disease and of the limited predictive value of in
vitro results for efficacy in humans, one of ordinary skill would be force
into undue experimentation in order to use the claimed invention.
Similarly, the examiner urges that, for essentially the same reasons, (Answer,
page 7):
the specification has failed to writtenly describe how one of ordinary skill
in the art would be enabled for the use of these compositions in in vitro
applications.
We agree that the specification lacks adequate support to enable those skilled in this
art to practice the invention as to the in vivo use or application of the claimed
monoclonal antibody composition in the absence of undue experimentation. Overall we
find that the examiner provides both evidence and sound scientific reasoning in support
of his position.
Appellants do not dispute the examiner's position as to the use of the claimed
composition in vivo. In rebuttal, appellants urge that Table 1 at page 9 of the
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