containing 10 to 20 mg of spironolactone as required by the claims. Appellant contends that “[a]
tablet or capsule containing 10 to 20 milligrams of an aldosterone antagonist has been found . . . to
serve the important function of inhibiting myocardial fibrosis without the adverse side effects that are
typically incurred at dosages large enough to control hypertension.” Appeal Brief, page 6. Appellant
asserts further that nothing in Greenberger suggests that an aldosterone antagonist should be
produced in the form of a tablet or capsule in a 10 to 20 mg dosage, as that dosage is not effective
for the control of blood pressure, the primary purpose for the administration of aldosterone
antagonists. See id.
As has already been noted, Greenberger discloses the administration of a spironolactone in the
claimed dosage. Admittedly, Greenberger does not specifically describe an article of manufacture
comprising a pharmaceutical tablet or capsule for oral ingestion comprising a pharmaceutical tablet
or capsule for oral ingestions comprising spironolactone in an amount within a rage of 10 to 20 mg,
but it would have been obvious to one of ordinary skill in the art to provide such an article of
manufacture for use in the protocol described by Greenberger in order to desensitize the
spironolactone intolerant patient. Appellant’s argument that Greenberger does not teach the
administration of a spironolactone in the claimed dosage for the treatment of myocardial fibrosis is
also not found to be convincing, as the treatment of myocardial fibrosis is intended use and not a
patentable limitation. See In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir.
1997).
Moreover, according to appellant, in Greenberger small dosages are only administered for a short
amount of time, providing no motivation for tablets or capsules to be manufactured in such dosages.
Appellant contends that the claims are patentable over Greenberger as unexpectedly favorable
results are obtained, i.e., control of myocardial fibrosis without the adverse side effects usually
experienced during aldosterone treatment for hypertension.
Greenberger describes readministration of a spironolactone for a single patient. But, Greenberger
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