evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955,
1956 (Fed. Cir. 1993) (citations omitted). The test of obviousness is “whether the teachings of the
prior art, taken as a whole, would have made obvious the claimed invention.” In re Gorman, 933
F.2d 982, 986, 18 USPQ2d 1885, 1888 (Fed. Cir. 1991). Moreover, changes in dosages are
normally not patentable unless “the results achieved at the designated concentration are
‘unexpectedly good.’” Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 809, 10 USPQ2d
1843, 1847
(Fed, Cir. 1989) (quoting In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977)).
Greenberger set forth a protocol for readministering spironolactone to a patient who initially
had an adverse reaction. The reference states that such readministration requires that “1) there be a
current essential indication for the drug; 2) there be no suitable pharmacologic alternatives; and 3)
the patient or family understand the risks involved.” Id. at 343, col. 2. The protocol describes
dissolving a 25 mg tablet in 25 ml of water, and teaches administration of a 20 mg dose, which is
within the claimed range. See id. at 344, Table I. Thus, as noted by the rejection, the reference
does not specifically describe an article of manufacture comprising a pharmaceutical tablet or
capsule for oral ingestion consisting of spironolactone in an amount within a rage of 10 to 20 mg. It
would have been obvious to one of ordinary skill in the art, however, to provide such an article of
manufacture rather than the use of the 20mg of liquid prepared by dissolving a 25mg for use in the
protocol described by Greenberger, as the tablet allows for ease of use and less opportunity for
dosing error, such as if the tablet does not completely dissolve or if too little water is used to dissolve
the tablet. The ordinary artisan would have been further motivated to produce such as tablet
because, as taught by Greenberger, such a readministration protocol is necessary when there is a
current essential indication for the drug and when there are no suitable pharmacologic alternatives.
Therefore, the rejection of claims 5 and 6 under 35 U.S.C. § 103(a) over Greenberger is affirmed.
Appellant argues that Greenberger does not disclose a tablet or capsule for oral ingestion
Page: Previous 1 2 3 4 5 6 Next
Last modified: November 3, 2007