Appeal No. 1997-3122
Application No. 08/082,848
does provide additional guidance: the specification teaches that the complex formed
between cyclosporin A and cyclophilin inhibits calcineurin (on the other hand, the
specification teaches that rapamycin is not an appropriate drug for the claimed method, as
it binds FKBP, but does not inhibit calcineurin) (pages 8 and 9).
Further, the specification identifies several other immunophilin-binding drugs (page
6) and teaches (with reference to several specific assay protocols) that “[t]he effectiveness
of a compound, and its relative potency as a calcineurin inhibitor, can be tested and
routinely determined by measuring inhibition of calcineurin activity, for example, by
monitoring the level of phosphorylation of NOS in cerebellar homogenates or cultured
neuronal cells . . . [a]lternatively, compounds can be tested to determine whether they
inhibit the amount of NO formed, cGMP formed, or cell death occurring after treatment with
glutamate or NMDA” (page 5).
We accept, for the sake of argument, that it would be time consuming to determine
which of the many known immunophilin-binding drugs also inhibit calcineurin. Nevertheless,
the examiner does not question the ability of one skilled in the art to follow the disclosed
processes. As explained in PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558,
1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996), undue experimentation has little to do
with the quantity of experimentation; it is much more a function of the amount of guidance
or direction provided:
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