Ex Parte Stokes

Board of Patent Appeals and Interferences

Apr 22, 2008

10255447 (B.P.A.I. Apr. 22, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte GORDON STOKES
____________

Appeal 2008-0226
Application 10/255,447
Technology Center 1600
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Decided: April 22, 2008
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Before DONALD E. ADAMS, LORA M. GREEN, and
RICHARD M. LEBOVITZ, 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 1 and 5-10. We have jurisdiction under
35 U.S.C. § 6(b). Claim 1 is representative of the claims on appeal, and
reads as follows:
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1. A composition for the treatment of hypertension, said composition
consisting essentially of a combination of:
in the range of 8 mg up to 600 mg of at least one angiotension II
inhibitor, and
in the range of 1 mg up to 200 mg of at least one nitric oxide donor,
said composition optionally further consisting essentially of a
pharmaceutically acceptable carrier, diluent and/or adjuvant.

The Examiner relies on the following references:
Shaw US 4,650,484 May 17, 1987
Ohtawa US 5,266,583 Nov. 30, 1993
Chobanian US 5,645,839 Jul. 8, 1997
Mann US 6,544,968 B2 Apr. 8, 2003

We affirm.

DISCUSSION
Claims 1 and 5-10 stand rejected under 35 U.S.C. § 103(a) as
Chobanian as combined with Mann, Ohtawa, and Shaw. As Appellant does
not argue the claims separately, we focus our analysis on claim 1, and claims
5-10 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
Chobanian is relied upon for teaching a composition comprising a
angiotensin II receptor antagonist (losarten) and a nitric oxide donor
(isosorbide dinitrate) (Ans. 4). Chobanian is also relied upon for teaching
that “the ratio of one compound to the other can be determined by
pharmacokinetics principles known to those skilled in the art, generally,
doses comparable to those used in hypertension or congestive heart failure.”
(Id.) According to the Examiner, the “teaching of Chobanian mainly differs
from the claimed invention in the specific dosage amounts of each active
ingredients in said composition, namely ‘in the range of 8 mg up to 600 mg
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of at least one angiotensin II inhibitor, and in the range of 1 mg up to 200
mg of at least one nitric oxide donor’” as in claim 1 (Id. at 5).
Mann is cited for teaching other known angiotensin II receptor
antagonists such as losartan, valsartan, irbersartan, telmisartan, and
candesartan (id. at 4).
Ohtawa is cited for teaching the administration of an angiotensin II
inhibitor such as losartin in the range of 5.0 to 500mg in the treatment of
hypertensions and/or congestive heart failure (id. at 5).
Shaw is cited for teaching “the use of 2.5 to 5mg of isosorbide
dinitrate [a nitric oxide donor] for the treatment of angina pectoris and/or
hypertension.” (Id.)
The Examiner concludes:
With respect to the instantly claimed specific dosage
range of each of the active ingredients, both Ohtawa and Shaw
demonstrates that claimed dosage ranges of angiotensin II
inhibitor and nitric oxide donor that are suitable for the
treatment of hypertension overlaps with the antifibrosis dosage
amounts of Chobanian. Thus, one would have been motivated
to combine these references and make the modification because
they are drawn to same technical fields (constituted with same
ingredients and share common utilities), and pertinent to the
problem which applicant concerns about. MPEP 2141.01(a).

(Id.)
“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 evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). The question of obviousness is resolved on
the basis of underlying factual determinations including: (1) the scope and
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content of the prior art; (2) the level of ordinary skill in the art; (3) the
differences between the claimed invention and the prior art; and (4)
secondary considerations of nonobviousness, if any. Graham v. John Deere
Co., 383 U.S. 1, 17 (1966). The Supreme Court has recently emphasized
that “the [obviousness] analysis need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727, 1741
(2007). “The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 1739. Moreover, an “[e]xpress suggestion to substitute one equivalent
for another need not be present to render such substitution obvious.” In re
Fout, 675 F.2d 297, 301 (CCPA 1982). Because the Examiner has provided
explicit evidence and logical reason and for having modified Chobanian, we
conclude that the Examiner has set forth a prima facie case of obviousness,
and thus turn to Appellant’s arguments in rebuttal.
Appellant argues that Chobanian is directed to compositions for the
treatment of fibrosis, whereas the instant composition is contemplated for
use in the treatment of hypertension (Br. 10-11). Chobanian, according to
Appellant, does not teach the use of eprosartan as the angiotensin II
inhibitor, and does not teach the specific dosage amounts required by the
claimed composition, and in fact, does not disclose any dosage amounts (id.
at 11 and 13). Appellant asserts that
the therapeutic goal, pathology, effects, nature, and timeline for
treatment employing the invention compositions, relative to the
methods disclosed by Chobanian, are all clearly distinct. Just
because certain compositions of angiotensin II inhibitors and
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nitric oxide donors may be known in the art for one purpose
(i.e., inhibiting fibrosis), one of skill in the art would have no
reason to expect any combination of these components,
especially a composition having a defined ratio of components,
would be useful for a distinctly different purpose (i.e., the
treatment of hypertension).

(Id. at 12).
Appellant’s arguments are not convincing. Claim 1 is directed to a
composition, and not a method of use. The recital of “for the treatment of
hypertension” is thus merely a statement of intended use, and not a
patentable limitation.
As noted by the Examiner (Ans. 4), Chobanian teaches a composition
comprising at least one angiotensin II inhibitor, one nitric oxide stimulator
(such as a nitric oxide donor), and at least one pharmaceutically acceptable
carrier (col. 4, ll. 12-64). Although not teaching specific dosages,
Chobanian teaches that the “ratio of one compound to the other may be
determined by pharmacokinetic principles known to those skilled in the art,”
but that “[i]n general, doses will be comparable to those used in
hypertension or congestive heart failure.” (Col. 6, ll. 6-9.) Thus, because
Chobanian teaches that the dosages are comparable as those for
hypertension, the ordinary artisan would expect that the dosages as required
by claim and the dosages arrived at using pharmacokinetic principles and the
guidance of Chobanian would be the same. Moreover, the Examiner has
presented evidence, in the form of Ohtawa and Shaw, of dosage ranges of
angiotensin II inhibitor and nitric oxide donor suitable for the treatment of
hypertension, and the dosage ranges provided by those references overlap
with the dosages required by claim 1.
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Appellant argues further that the Examiner’s reliance on Mann to
remedy the deficiencies of Chobanian is improper, as the instant claims
require compositions for the treatment of hypertension, whereas Mann
teaches the treatment of acute myocardial infarction using an angiotensin II
receptor antagonist (Br. 13). Mann, Appellant asserts, fails to teach or
suggest the specific combination of active agents required by the claims, but
discloses the use of a single class of active compounds (angiotensin II
receptor antagonists) (id. at 13-14).
Appellant errs in attacking the Mann reference individually, as the
rejection is based on a combination of references. See In re Merck & Co.,
Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references relied upon in
the obviousness rejection cannot be read in isolation, but for what they teach
in combination with the prior art as a whole. See id. In this case, Chobanian
teaches a composition comprising at least one angiotensin II inhibitior, such
as a angiotensin II receptor antagonist, one nitric oxide stimulator (such as a
nitric oxide donor), and at least one pharmaceutically acceptable carrier (col.
4, ll. 12-64). Mann is merely cited for teaching other known angiotensin II
receptor antagonists, such as losartan, valsartan, irbersartan, telmisartan, and
candesartan (Ans. at 4). Thus, as Chobanian teaches the use of an
angiotensin II receptor antagonist and a one nitric oxide donor in a
composition, it would have been obvious to use any known angiotensin II
receptor such as those taught by Mann.
Appellant asserts that Ohtawa and Mann fail to cure the deficiencies
of Chobanian and Mann (Br. 14). Both Ohtawa and Mann each teach the
use of a single active agent, and thus, Appellant argues, fail to teach or
suggest the use of a combination of at least one angiotensin II inhibitor and
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at least one nitric oxide donor (id. at 14). Appellant asserts that “the present
invention and the prior art relied upon by the Examiner are directed to the
treatment of individuals from different populations with different problems.”
(Id. at 16.) Thus, according to Appellant, “because each reference (i.e.,
Chobanian, Mann, Ohtawa and Shaw, respectfully) is directed to solving a
different problem (i.e., fibrosis, acute myocardial infarction, hypertension
and ischemic condition), there is no motivation to combine the references.”
(Id.) Appellant asserts that the Examiner has used improper hindsight,
using Appellant’s disclosure as a blueprint, in combining the references to
arrive at the claimed invention (id. at 18-19).
Again, Appellant is arguing the references in isolation. As noted
above, Chobanian teaches a composition comprising at least one angiotensin
II inhibitor, such as a angiotensin II receptor antagonist, one nitric oxide
stimulator (such as a nitric oxide donor), and at least one pharmaceutically
acceptable carrier (col. 4, ll. 12-64). As to the different problems addressed
by the references, although Chobanian teaches the use of the composition in
the treatment of fibrosis, Chobanian specifically teaches that the dosages are
comparable to those used in the treatment of hypertension and congestive
heart failure. Ohtawa and Shaw were then cited for teaching dosage ranges
of the components in the composition used for the treatment of hypertension
(Answer 5), and thus are relevant to the problem addressed by Chobanian.
Moreover, as to motivation to combine, the Supreme Court in KSR
Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1739 (2007), rejected a rigid
application of the teaching-suggestion-motivation test. The Court
recognized that it is often necessary to look at the interrelated teaches of
multiple references; the effects of demands of the marketplace; and the
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background knowledge possessed by a person of ordinary skill, “all in order
to determine whether there was an apparent reason to combine the known
elements in the fashion claimed.” Id. at 1740-41. Moreover, the
“obviousness analysis cannot be confined by a formalistic conception of the
words teaching, suggestion, or motivation, or by overemphasis on then
importance of published articles and explicit content of issued patents.” Id.
at 1741.
CONCLUSION
In summary, we affirm the rejection of claims 1 and 5-10 under 35
U.S.C. § 103(a) as Chobanian as combined with Mann, Ohtawa, and Shaw
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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