Ex Parte Aberg

Board of Patent Appeals and Interferences

Jun 22, 2011

11474154 (B.P.A.I. Jun. 22, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/474,154 06/23/2006 A.K. Gunnar Aberg 559P032A 9139
42754 7590 06/22/2011
Nields, Lemack & Frame, LLC
176 E. Main Street
Suite #5
Westborough, MA 01581
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
06/22/2011 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte A. K. GUNNAR ABERG
__________

Appeal 2011-000414
Application 11/474,154
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and FRANCISCO C.
PRATS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for treating incontinence. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses the “use of trospium … for treating
smooth muscle hyperactivity disorders, such as … urinary incontinence …,
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Application 11/477,154

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while avoiding the cardio-depressive effects of other anticholinergic
compounds” (Spec. 2).
Claims 24, 26-34, 37, and 38 are on appeal. Claim 24 is
representative and reads as follows:
24. A method for treating urinary voiding disorders in an individual,
comprising determining whether said individual suffers from a cardiac
contractility disorder, and if said determination is positive, administering to
said individual a therapeutically effective amount of trospium or a
pharmaceutically acceptable salt thereof.

Issue
The Examiner has rejected claims 24, 26-32, 34, 37, and 38 under 35
U.S.C. § 103(a) as being obvious in view of Dmochowski,1 Halaska2 and
Kesten.3 Claims 26-32, 34, 37 and 38 have not been argued separately and
therefore stand or fall with claim 24. 37 C.F.R. § 41.37(c)(1)(vii). The
Examiner has also rejected claim 33 under 35 U.S.C. § 103(a) as being
obvious in view of Dmochowski, Halaska, Kesten, and Baba.4 Since
Appellant has waived any argument based on Baba (Appeal Br. 13-14), we
will consider the rejections together.
The Examiner finds that Dmochowski discloses the “administration of
trospium to patients for the treatment of urge incontinence” (Answer 5) and
Halaska discloses the administration of trospium for treatment of urinary

1 Dmochowski et al., Advancements in Pharmacologic Management of the
Overactive Bladder, 56 (SUPPL. 6A) UROLOGY 41-49 (2000).
2 Halaska et al., Controlled, Double-Blind, Multicenter Clinical Trial to
Investigate Long-Term Tolerability and Efficacy of Trospium Chloride in
Patients with Detrusor Instability, 20 WORLD J. UROL. 392-399 (2003).
3 Kesten, US 2006/0173038 A1, published August 03, 2006
4 Baba, US 5,112,872, issued May 12, 1992
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Application 11/477,154

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incontinence (id.). The Examiner finds that Kesten discloses “a method of
treating and preventing heart failure … [by] administering anticholinergic
compounds such as trospium salts” (id.), and that “heart failure is a common
disorder of the heart, in which the contractility of the heart muscle
(myocard) is impaired” (id.).
The Examiner concludes that it would have been obvious to treat
urinary incontinence with trospium because “Halaska and Dmochowski …
teach that trospium is useful in a method of treating smooth muscle
disorder[s] such as urinary incontinence in patients including the elderly
population” and, in addition, Kesten discloses that “trospium is administered
in a method of treating or preventing heart failure” (id. at 6). The Examiner
reasons that although the “references do not explicitly teach the step of
determining patients with contractility disorders … [i]t is well known in the
art to diagnose such conditions in a patient to determine whether the patients
have preexisting cardiac contractility conditions” (id.).
Appellant contends that the cited references do not disclose or suggest
determining whether an individual with a urinary voiding disorder also
suffers from a cardiac contractility disorder and, if that determination is
positive, treating with trospium (Appeal Br. 7).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that the cited references would have made it obvious
to determine whether an individual with a urinary voiding disorder also
suffers from a cardiac contractility disorder and, if so, treat the individual
with trospium?
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Findings of Fact
1. Halaska discloses that “[a]nticholinergic drugs such as trospium
chloride…, constitute the basic therapy for urinary urge incontinence”
(Halaska 393).
2. Dmochowski discloses that in “a study of 2,647 evaluable patients
treated for 30 days with trospium, frequency [of urination] was reduced by
40% and urge symptomatology by 87%” (Dmochowski 46).
3. Kesten discloses “a method for the prevention or the treatment of
heart failure comprising [the] administration of a therapeutically effective
amount of … trospium salts” (Kesten, ¶ 0003).
4. The Specification states that the “most well known cardiac
contractile disorders are heart failure or congestive heart failure” (Spec. 6).
Analysis
Claim 24 is directed to a method for treating urinary voiding disorders
comprising determining whether an individual suffers from a cardiac
contractility disorder and if so, administering a therapeutically effective
amount of trospium.
Halaska discloses that anticholinergic drugs such as trospium chloride
are a basic therapy for urinary urge incontinence. Dmochowski discloses
that trospium is effective in treating urinary incontinence. Kesten discloses
treatment of heart failure by administration of trospium salts. As recognized
by the Examiner, it is well known to assess patients’ medical histories,
including “whether the patients have pre-existing cardiac contractility
conditions” (Answer 9), such as a history of heart failure, before prescribing
medications. We agree with the Examiner that it would have been obvious
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Application 11/477,154

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to one of ordinary skill in the art to treat patients for urinary incontinence
with trospium after first identifying a cardiac contractility disorder because
trospium is known in the art for treatment of both incontinence and heart
failure.
Appellant argues that one of skill in the art would not have
administered trospium to patients with cardiac contractility disorders
because “[o]ther medications for overactive bladder (OAB)/urinary
incontinence (UI), such as the market leaders tolterodine and oxybutynin,
are known to cause cardiodepression” and therefore those of skill in the art
would have expected trospium to also have cardiodepressive effects (Appeal
Br. 7-8). Appellant also argues that trospium is a tropane analog and
members of “the tropane class of molecules are known to have high risk for
causing significant cardiac side effects” (id. at 8).
This argument is not persuasive. Appellant cites no evidence to
support the assertion that skilled workers would have expected trospium to
cause cardiodepression or other cardiac side effects, and attorney argument
is not evidence. Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir.
1989) (“Attorneys’ argument is no substitute for evidence.”). On the
contrary, Appellant has not pointed to anything in Halaska nor Dmochowski
that warns against using trospium in patients with cardiac contractility
disorders, and Kesten actually discloses using trospium to treat heart failure.
Thus, the preponderance of the evidence of record does not support
Appellant’s position that a skilled worker would not have administered
trospium to a patient with a cardiac contractility disorder.
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Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have made it obvious to determine whether an
individual with a urinary voiding disorder also suffers from a cardiac
contractility disorder and if so, administer trospium.
SUMMARY
We affirm the rejections of claims 24, 26-34, 37, and 38 under
35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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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