Appeal No. 1995-1989
Application 07/850,142
to acute phase reactants.” Answer, p. 4. The examiner argues, inter alia,
that:
[i]t has not been demonstrated that either the method of immunizing using
pooled samples from Alzheimer’s patients or the method of immunizing
using paired helical filaments (PHF) from Alzheimer’s patients ... as
disclosed would reproducibly result in other monoclonal antibodies which
would bind to other acute phase reactants as claimed and have the
properties required to practice the invention. There is no guidance or
information or evidence of record as to what is required to obtain
monoclonal antibodies that would work as claimed, or that there is any
difference at all between AD patients and normal controls with respect to
other monoclonal antibody binding to acute phase reactants in Alzheimer’s
disease patients, and should there be a difference, one would not know
whether every acute phase reactant-specific monoclonal antibody would be
appropriate to use or whether one would have to seek a monoclonal to some
particular and as yet undefined epitope on one or more acute phase
reactants. . . . Appellants have not identified any other acute phase
reactant epitopes that would be useful in the methods as claimed except for
those specifically recognized by the particular monoclonals exemplified . . . It
would require undue experimentation for one of ordinary skill in the art to
produce or to identify other acute phase reactant monoclonal antibodies that
would have all the properties required or would bind to the unidentified
epitopes in order to practice the invention as claimed since Appellants’
procedure for producing monoclonal antibodies to acute phase reactants
has not been demonstrated to be reproducible [Answer, pp. 4-5].
* * *
In the case of alpha haptoglobin, it appears that the epitope bound by Appellants’
monoclonal antibodies may be one that is unique to Alzheimer’s disease [Answer,
p. 6].
* * *
[I]t is not evident that, using the instant specification as a guide, one could readily
make other antibodies to properdin P like Appellants’ that would work in the
claimed method. It would require undue experimentation for one of ordinary skill in
the art to identify other epitopes present on alpha-chain haptoglobin or properdin P
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