Appeal No. 1997-3330
Application No. 08/271,870
DECISION
35 U.S.C. § 103
Claims 1, 3-6, 8-26 and 28-41 stand rejected under 35 U.S.C. § 103 as obvious
over Nelson taken with Rose and either of Erlanger or Brinkley.
The claimed invention is directed to:
1. A method for the determination of mycophenolic acid in a sample suspected
of containing mycophenolic acid comprising the steps of:
(a) contacting said sample with a monoclonal antibody capable of distinguishing
between mycophenolic acid and mycophenolate esters; and
(b) detecting the binding of said antibody to mycophenolic acid, the presence of
said binding indicating the presence and/or the amount of mycophenolic acid in said
sample.
Nelson describes mycophenolic acid and its derivatives as being well known
pharmaceuticals useful as immunosuppressive, anti-inflammatory and anti-tumor agents.
The examiner argues that for this reason, the development of bioavailability assays for
these compounds would be expected to be routine in the art. Examiner’s Answer, page 4.
Rose is relied on for the general disclosure of conventional immunoassay formats
including the competitive ELISA format which is useful for the assay of haptens.
Examiner’s Answer, page 5. Each of Erlanger and Brinkley are relied on for the
disclosure of conventional methods of preparing immunogenic conjugates and tracers by
coupling a hapten with an immunogenic carrier or label. The conjugates are useful in the
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