Ex Parte Kesten et al

Board of Patent Appeals and Interferences

Nov 9, 2010

11332646 (B.P.A.I. Nov. 9, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEVEN KESTEN and KLAUS VIEL
__________

Appeal 2010-009343
Application 11/332,646
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. MCCOLLUM, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for treating heart failure, pulmonary edema, and atrial fibrillation

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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Application 11/332,646

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by administering a tiotropium salt. The Patent Examiner rejected the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

STATEMENT OF THE CASE
Claims 1, 3, 4, 15-21, and 28-32 are on appeal. Claims 1, 20, and 21
are representative and read as follows:
1. A method for the treatment of heart failure comprising administration
of a therapeutically effective amount of an anticholinergic which is a
tiotropium salt, optionally together with a pharmaceutically acceptable
excipient.

20. A method for the treatment of pulmonary edema comprising
administration of a therapeutically effective amount of an anticholinergic
which is a tiotropium salt, optionally together with a pharmaceutically
acceptable excipient.

21. A method [sic] the treatment of atrial fibrillation comprising
administration of a therapeutically effective amount of an anticholinergic
which is a tiotropium salt, optionally together with a pharmaceutically
acceptable excipient.

The Examiner rejected the claims under 35 U.S.C. § 103(a) as
unpatentable over Uren2 and Gross,3 as evidenced by Fiutowski.4

2 N.G. Uren et al., Inhaled bronchodilators increase maximum oxygen
consumption in chronic left ventricular failure, 14 EUROPEAN HEART
JOURNAL, no. 6, 744-750 (1993).
3 Nicholas J. Gross, Tiotropium Bromide, 126 CHEST JOURNAL, no. 6, 1946-
1953 (2004).
4 M. Fiutowski et al., Clinical Presentation and Pharmacological Therapy,
61 KARDIOL. POL., no. 12, 561-569 (2004).
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Claims 3, 4, 15-19 and 28-32 have not been argued separately and
therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is that Uren disclosed that
bronchoconstriction is seen at rest in patients with chronic heart failure and
contributes to exercise limitation. (Ans. 3.) The Examiner found that Uren
disclosed administering bronchodilators, including an anticholinergic
bronchodilator to heart failure patients. (Id.) The Examiner found that Uren
explained that the significant increase to exercise capacity in chronic heart
failure following administration of bronchodilator agents implied that a
degree of bronchoconstriction is present in these patients and contributes to
exercise limitation. (Id.) However, the Examiner found that Uren did not
expressly disclose administering a tiotropium salt. (Id.)
The Examiner found that Gross disclosed tiotropium bromide as an
inhaled bronchodilator. (Id. at 4.) According to the Examiner, it would have
been obvious to a person of ordinary skill in the art at the time the invention
was made to treat heart failure with tiotropium bromide motivated by a
reasonable expectation of successfully treating bronchoconstriction
associated with heart failure by using a drug known to cause
bronchodilation. (Id.)
Regarding instant claims 20 and 21, the Examiner found that
Fiutowski taught “that cardiogenic pulmonary oedema is typically a clinical
presentation of acute heart failure and etiologically related to paroxysmal
atrial fibrillation.” (Id.)
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Appellants contend that “the claimed method for treating heart failure
is not met or suggested by prior art which suggests treating only one
symptom sometimes associated with heart failure.” (App. Br. 5.) In
support, Appellants cite Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir.
2001), and explain “[t]he Court rejected Rapoport’s argument that a count
was unpatentable on the ground that the prior art disclosed administering the
compound- not for treatment of sleep apnea itself- but for treatment of
anxiety and breathing difficulty, a symptom of apnea….” (App. Br. 4.)
According to Appellants, the same reasoning applies here, i.e., Uren’s
teaching to “use a bronchodilator to treat the symptom of
bronchoconstriction, which is one possible symptom of heart failure, is not a
teaching to treat the underlying condition.” (Id.) Appellants further assert
that Fiutowski’s disclosure that “underlying etiology seems to be one of the
most important factors influencing therapy” supports the position that
treating one symptom would not be reasonably expected to treat the
underlying disease. (Id.)
Appellants argue that the claimed methods of treating pulmonary
edema and atrial fibrillation are separate embodiments from treating heart
failure. (Id. at 4-5.) According to Appellants, none of the cited references
suggest that tiotropium salts would be useful for treating pulmonary edema
or atrial fibrillation. (Id. at 6-7.) According to Appellants, “there is no basis
to conclude that a method/drug for treating one symptom of a disease would
also be useful to treat another symptom.” (Id. at 7.)
The issue with respect to this rejection is whether the record supports
the Examiner’s conclusion that the cited references would have made the
claimed methods obvious.
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Findings of Fact
1. We agree with the Examiner’s explicit findings regarding the scope
and content of the prior art references. (See Ans. 3-4.)

Principles of Law
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” KSR, 550 U.S. at 416.
Disclosing a new benefit of an old process does not render that old
process patentable. Perricone v. Medicis Pharmaceutical Corp., 432 F.3d
1368, 1377-78 (Fed. Cir. 2005); Bristol-Myers Squibb Co. v. Ben Venue
Laboratories, Inc. 246 F.3d 1368, 1376 (Fed. Cir. 2001) (“[n]ewly
discovered results of known processes directed to the same purpose are not
patentable because such results are inherent.”)

Analysis
Independent Claim 1
We are not persuaded by Appellants’ arguments that Uren did not
teach a method for treating heart failure. (See App. Br. 3.) As the Examiner
found, Uren disclosed that a degree of bronchoconstriction is present in
patients with chronic heart failure, and the bronchconstriction contributes to
the exercise limitation characteristic of heart failure patients. (See Ans. 3.)
The Examiner also correctly found that Uren disclosed administering
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bronchodilators, including an anticholinergic bronchodilator to heart failure
patients. (Id.) These findings distinguish this rejection from the facts
involved in Rapoport. In Rapoport, the prior art only taught the treatment of
anxiety, and not sleep apnea. There was no record evidence demonstrating
that anxiety is a component of sleep apnea, or that treatment of anxiety
inherently treated sleep apnea. Here, however, the prior art specifically
disclosed that “[b]ronchoconstriction is seen at rest in patients with chronic
heart failure” and expressly described administering bronchodilators to heart
failure patients. (See Ans. 3.) In other words, Uren disclosed treating heart
failure patients with bronchodilators. In Uren, the bronchodilators were
administered to the heart failure patients specifically to determine whether a
bronchodilator response improved a recognized component of heart failure,
i.e., exercise limitation. To the extent that Appellants argue that Uren did
not treat heart failure, we disagree. Uren explicitly taught that their
treatment gave a “small but significant increase in exercise capacity in
chronic heart failure.” (Uren, Abstract; Ans. 3.) See Perricone, 432 F.3d at
1377-78; Bristol-Myers Squibb Co., 246 F.3d at 1376.
This result is unchanged by Appellants’ reference to Fiutowski’s
disclosure that “the underlying etiology seems to be one of the most
important factors influencing therapy.” (See App. Br. 4.) Fiutowski made
this statement specifically with respect to therapeutic strategies for treating
cardiogenic pulmonary edema. Fiutowski suggested that treating
cardiogenic pulmonary edema should be guided by the cause of the edema,
e.g., blood pressure, paroxysmal atrial fibrillation, etc. Therefore, we do not
find that this reference supports Appellants’ assertion that Uren’s disclosure
did not teach a method of treating heart failure.
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Nor do we find that Appellants’ argument regarding claim 1 gains
weight from the fact that the Specification disclosed methods for treating
pulmonary edema and atrial fibrillation “as separate embodiments from
treating heart failure.” (See App. Br. 4-5.) This argument is misdirected as
the issue with regard to claim 1 is whether the combined prior art disclosed a
method of treating heart failure, not whether the prior art method
encompassed these “separate embodiments.”
Independent Claims 20 and 21
We reach a different result regarding the rejection of claim 20 directed
to a method for treating pulmonary edema, and claim 21 directed to a
method for treating atrial fibrillation. For these rejections, the Examiner
made an additional finding that Fiutowski taught “that cardiogenic
pulmonary oedema is typically a clinical presentation of acute heart failure
and etiologically related to paroxysmal atrial fibrillation.” (See Ans. 4.)
However, the Examiner did not explain how the combined prior art would
have taught or suggested a method of treating pulmonary edema and atrial
fibrillation with tiotropium. Consequently, we reverse the rejections of
claims 20 and 21.

CONCLUSIONS OF LAW
The record supports the Examiner’s conclusion that the cited
references would have made claim 1’s method for treating heart failure
obvious. However, the Examiner has not established a prima facie case of
obviousness regarding the claimed method for treating pulmonary edema
and the claimed method for treating atrial fibrillation, recited in claims 20
and 21, respectively.
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SUMMARY
We affirm the rejection of claims 1, 3, 4, 15-19 and 28-32; and
we reverse the rejection of claims 20 and 21.

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-IN-PART

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MICHAEL P. MORRIS
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