Ex parte MITA et al.

Board of Patent Appeals and Interferences

Nov 29, 2000

08208497 (B.P.A.I. Nov. 29, 2000)

1
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written for publication and is not binding precedent of the Board.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. 32
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte SHIRO MITA and EIICHI SCHIRASAWA
__________
Appeal No. 1997-3135
Application 08/208,497
__________
ON BRIEF
__________
Before WINTERS, ROBINSON, and LORIN, Administrative Patent Judges.
WINTERS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal was taken from the examiner's decision rejecting claims 9-14 and
21-29, which are all of the claims remaining in the application.
Appeal No. 1997-3135
Application 08/208,497
2
Claim 9, which is illustrative of the subject matter on appeal, reads as follows:
9. A method for treating glaucoma which comprises administering an effective
amount of a therapeutic agent for glaucoma comprising, as active ingredient, a compound
of the following formula (I) or its salt:
wherein R represents one or more groups selected from the group consisting of a1
hydrogen atom, lower alkyl groups, halogen atoms, a nitro group, a hydroxyl group, lower
alkoxy groups, lower alkanoyloxy groups, an amino group, lower alkylamino groups and
lower alkoxycarbonyl groups, R represents a hydrogen atom, a lower alkyl group or a2
cycloalkyl group having 3 to 6 carbon atoms, R represents one or more groups selected3
from the group consisting of a hydrogen atom, lower alkyl groups, a hydroxyl group, lower
alkoxy groups, halogen atoms, a nitro group, lower alkylenedioxy groups, lower alkanoyl
groups, lower alkanoyloxy groups, an amino group, lower alkylamino groups, lower
alkanoylamino groups and lower alkoxycarbonyloxy groups, or a group of -(CH ) -, R2 n
4
represents a hydrogen atom or a lower alkyl group, A and B may be the same or different
from each other and each represent a lower alkylene group having 1 to 6 carbon atoms,
and n represents 3 or 4, and pharmaceutically acceptable diluent and/or carrier to a patient
suffering from glaucoma.
The prior art references relied on by the examiner are:
Fujita et al. (Fujita), “Synthesis and Ca Antagonistic Activity of 2-[2-[(Aminoalkyl)oxy]-5-2+
methoxyphenyl]-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzothiazines,” J. Med. Chem., Vol.
33, pp. 1898-1905 (1990)
Appeal No. 1997-3135
Application 08/208,497
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Abelson et al. (Abelson), “Sustained Reduction of Intraocular Pressure in Humans With the
Calcium Channel Blocker Verapamil,” American Journal of Ophthalmology, Vol. 105, pp.
155-59 (Feb. 1988)
The issue presented for review is whether the examiner erred in rejecting claims 9-
14 and 21-29 under 35 U.S.C. § 103 as unpatentable over the combined disclosures of
Fujita and Abelson.
Our deliberations in this matter have included evaluation and review of the following
materials: (1) the instant specification, including all of the claims on appeal;
(2) applicants' Appeal Brief and Reply Brief; (3) the Yamauch declaration, filed under the
provisions of 37 CFR § 1.132, dated November 14, 1994; (4) the Examiner's Answer and
the communication mailed by the examiner March 19, 1996; and (5) the above-cited
references relied on by the examiner.
On consideration of the record, including the above-listed materials, we reverse the
examiner's rejection under 35 U.S.C. § 103.
DISCUSSION
The appealed claims relate to a method for treating glaucoma by
administering an effective amount of a therapeutic agent comprising, as the active
ingredient, a specified 2-phenyl-3-oxo-2H-1,4-benzothiazine compound and a
pharmaceutically acceptable diluent and/or carrier to a patient suffering from glaucoma.
Appeal No. 1997-3135
Application 08/208,497
4
The active ingredient 2-phenyl-3-oxo-2H-1,4-benzothiazine compounds are spelled out by
way of chemical formula in claim 9 on appeal.
According to the examiner, Fujita discloses that applicants' 2-phenyl-3-oxo-2H-1, 4-
benzothiazine compounds are Ca antagonists or calcium channel blockers. The2+
examiner argues that Abelson discloses the use of calcium channel blockers for treating
glaucoma by the sustained reduction of intraocular pressure in humans. The examiner
concludes that the combined disclosures of Fujita and Abelson would have led a person
having ordinary skill to the claimed invention because: (1) it was known, at the time the
invention was made, that applicants' 2-phenyl-3-oxo-2H-1,4-benzothiazine compounds
were calcium channel blockers (Fujita); (2) it was known that calcium channel blockers
were useful for treating glaucoma by the sustained reduction of intraocular pressure in
humans (Abelson); and (3) therefore, it would have been obvious to a person having
ordinary skill in the art to use applicants' 2-phenyl-3-oxo-2H-1,4-benzothiazine compounds
for treating glaucoma by administering an effective amount of such compound in
combination with a pharmaceutically acceptable diluent or carrier to a patient suffering
from glaucoma. We disagree.
The examiner's argument is flawed because it is unsupported by evidence of
record. The examiner's position to the contrary, notwithstanding, Abelson does not
disclose using calcium channel blockers, generically, for treating glaucoma. Rather,
Appeal No. 1997-3135
Application 08/208,497
Beatty et al., “Elevation of intraocular pressure by calcium channel blockers,” Arch.1
Ophthalmol., 102:1072 (1984).
5
Abelson reports that topical administration of the calcium channel blocker Verapamil
elicited a significant and sustained reduction of intraocular pressure in human subjects with
ocular hypertension. According to Abelson, this finding is supported by a previous study
where oral administration of the calcium channel blocker Nitrendipine caused a significant
drop in intraocular pressure. See Abelson, page 157, left-hand column, last paragraph,
referring to Monica et al. “the effect of a calcium-channel blocking agent on intraocular
pressure,” American Journal of Ophthalmology, 96:814 (1983). On the other hand,
Abelson acknowledges that his results conflict with those of Beatty and Associates, who1
found a slight increase in pressure (1 or 2mm Hg) in humans who had received topical
Verapamil. See Abelson's discussion of the Beatty reference at page 155, right-hand
column, first full paragraph; and the paragraph bridging pages 157-58. Abelson also
discloses that Diltiazem, another calcium channel blocker, did not lower intraocular
pressure in a pilot study of ten ocular hypertensive subjects (unpublished data). See
Abelson, page 158, left-hand column, last full paragraph.
In sum, Abelson does not disclose using calcium channel blockers, generically, for
treating glaucoma. According to Abelson, the topical administration of Verapamil elicited
a significant and sustained reduction of intraocular pressure in human subjects with ocular
Appeal No. 1997-3135
Application 08/208,497
6
hypertension, and this finding is supported by a previous study where oral administration of
Nitrendipine caused a significant drop in intraocular pressure. On the other hand,
Abelson's results conflict with those of Beatty and Associates, who found a slight increase
in pressure in humans who had received topical Verapamil. Abelson also discloses that
Diltiazem did not lower intraocular pressure in a pilot study of ten ocular hypertensive
subjects (unpublished data). This means to say that some calcium channel blockers
cause a decrease in intraocular pressure and others do not, and these facts were known to
persons having ordinary skill in the art at the time applicants' invention was made. As
stated by Abelson, page 158, left-hand column, last full paragraph, “[t]he pharmacologic
profile of different calcium channel antagonists is varied.”
Where, as here, the cited prior art does not disclose using calcium channel
blockers, generically, for treating glaucoma by the sustained reduction of intraocular
pressure in humans, the premise of the examiner's rejection is unsupported by evidence
and the rejection must fall. At the time applicants' invention was made, it was known that
some calcium channel blockers cause a decrease in intraocular pressure and others do
not. On this record, the examiner has not established that when all of the prior art is
considered together, a person having ordinary skill would have had a sufficient basis for
the necessary predictability of success to sustain a rejection under 35 U.S.C.§ 103. In re
Clinton, 527 F.2d 1226, 1228, 188 USPQ 365, 367 (CCPA 1976). The examiner has not
Appeal No. 1997-3135
Application 08/208,497
7
established that a person having ordinary skill in the art would have reasonably expected
that applicants' 2-phenyl-3-oxo-2H-1,4-benzothiazine compounds would be useful in a
method for treating glaucoma.
The examiner's error, we believe, stems from focusing on those portions of Abelson
which support the rejection under 35 U.S.C. § 103 but ignoring other portions of the
reference which do not support the rejection. In other words, the examiner misapprehends
the scope and content of the prior art, considerably overstates the significance of Abelson,
and does not adequately evaluate the Abelson reference in its entirety. As stated in In re
Hedges, 783 F.2d 1038, 1049, 228 USPQ 685, 687 (Fed. Cir. 1986), quoting from In re
Wesslau, 353 F.2d 238, 241, 147 USPQ 391, 393 (CCPA 1965),
It is impermissible within the framework of section 103 to pick and choose
from any one reference only so much of it as will support a given position, to
the exclusion of other parts necessary to the full appreciation of what such
reference fairly suggests to one of ordinary skill in the art.
Accordingly, on this record, the examiner has not established a prima facie case of
obviousness of the appealed claims. We find it unnecessary to discuss the Yamauch
declaration, dated November 14, 1994, relied on by the applicants as rebutting any such
prima facie case.
Appeal No. 1997-3135
Application 08/208,497
8
For the reasons set forth above, and those presented more fully in applicants'
Appeal Brief and Reply Brief, we reverse the rejection of claims 9-14 and 21-29 under 35
U.S.C. § 103 as unpatentable over the combined disclosures of Fujita and Abelson.
The examiner's decision is reversed.
REVERSED
Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Douglas W. Robinson )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Hubert C. Lorin )
Administrative Patent Judge )
SDW/cam
Appeal No. 1997-3135
Application 08/208,497
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