Ex Parte Weber

Board of Patent Appeals and Interferences

Nov 28, 2003

09556352 (B.P.A.I. Nov. 28, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 31

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KARL T. WEBBER
__________

Appeal No. 2003-1024
Application No. 09/556,352
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ON BRIEF
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Before ADAMS, MILLS, and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s final rejection of
claims 5 and 6, which are reproduced below.
5. An article of manufacture comprising a pharmaceutical tablet or capsule for oral
ingestion, comprising spironolactone in an amount within a range of 10 to 20 milligrams.

6. An article of manufacture comprising a pharmaceutical tablet or capsule for oral
ingestion, comprising spironolactone in an amount within a range of 10 to 20 milligrams, so
as to be therapeutically effective in suppressing aldosterone-mediated myocardial fibrosis
without substantially increasing sodium excretion and without substantially reducing
potassium retention by the body.

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The examiner relies upon the following references:
Greenberger et al. (Greenberger) “Readministration of Spironolactone in the Spironolactone-
Intolerant Patient,” NER Allerge Proc, pp. 343-345 (1986)

Remington’s Pharmaceutical Sciences, XIVth edition, Mark Publishing Company, pp. 867-868

The claims stand rejected under 35 U.S.C. § 103(a) as being obvious over Greenberger or
Remington’s Pharmaceutical Sciences. After careful review of the record and consideration of the
issues before us, we affirm the rejection over Greenberger, and thus need not reach the rejection
over Remington’s Pharmaceutical Sciences.
DISCUSSION
Claims 5 and 6 stand rejected under 35 U.S.C. § 103(a) as being obvious over either
Greenberger or Remington’s Pharmaceutical Sciences. As we are affirming the rejection over
Greenberger, we need not reach the rejection over Remington’s Pharmaceutical Sciences, and thus
we limit our analysis on the rejection over Greenberger.
According to the Answer:
Greenberger [ ] disclose[s] that readministration of spironolactone is done by
serially increasing doses from 1mg to 400 mg. The instant claims differ over
Greenberger [ ] in reciting an article of manufacture comprising a pharmaceutical tablet
or

capsule for oral ingestion comprising spironolactone in an amount within a range of 10
to 20 mg. However, it would have been obvious to one of ordinary skill in the art to
administer a tablet or capsule having 10 to 20 mg or to break the available 25 mg tablet
into smaller pieces, including a piece within the recited range of 10 to 20 mg. One
would be motivated to do so because of the desire to desensitize the spironolactone
intolerant patient.

Examiner’s Answer, pages 3-4.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a
prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with
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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
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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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also teaches that such readministration is necessary when there is a current essential indication for
the drug and when there are no suitable pharmacologic alternatives. Thus, in order to administer the
protocol to a large number of patients, and also to reduce dosing errors, one of ordinary skill would
have been motivated to produce the spironolactone as a capsule or tablet in the smaller disclosed
dosages required by the protocol. Appellant’s argument that unexpectedly favorable results are
obtained using the claimed dosages is also not convincing as Greenberger specifically teaches
administration of the spironolactone at the claimed dosage amount.
OTHER MATTERS
Appellant also argues that the terminal disclaimer filed along with the petition to revive, mailed
August 2, 2001, is proper. See Appeal Brief, page 8. The examiner asserts that the terminal
disclaimer is improper because it fails to reference the instant application or identify the parent
application in the body of the terminal disclaimer. That is a formal matter subject to petition,
however, and the Board is not the proper forum to review the examiner’s conclusion that the terminal
disclaimer is improper. See MPEP § 1201.

No time period for taking any subsequent action in connection with this appeal may be extended
under 37 CFR § 1.136(a).
AFFIRMED

Donald E. Adams )
Administrative Patent Judge )
)
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)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

LG/dym

Susan J Wharton
Shook Hardy & Bacon LLP
1200 Main Street
Kansas City, MO 64105-2118

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