Ex Parte Disse et al

Patent Trial and Appeal Board

Dec 8, 2014

11468871 (P.T.A.B. Dec. 8, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte BERND DISSE, STEVEN KESTEN, and THEODORE WITEK1
__________

Appeal 2012-006855
Application 11/468,871
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
ROBERT A. POLLOCK, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
rejections of claims 1–8 and 14–21. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.
STATEMENT OF THE CASE
Appellants’ invention relates to “a method for improving the ability of
patients suffering from lung diseases to participate in and benefit from
pulmonary rehabilitation programs comprising the administration of a

1 According to Appellants, the Real Party in Interest is Boehringer Ingelheim
International GmbH. (App. Br. 1.)
Appeal 2012-006855
Application 11/468,871

2
therapeutically effective amount of tiotropium salts.” (Spec. 3:4–6.) Claims
1–8 and 14–21 are before us. Appellants direct their arguments to
independent claim 1, which is representative of the claims on appeal.
Appellants set forth no independent arguments with respect to claims 2–8
and 14–21, which stand or fall with claim 1. (See App. Br. 11.)
Claim 1 is reproduced below (reformatted from the version set forth in
Appellants’ Claims Appendix):
1. A method for improving the ability of a patient
suffering from a lung disease to participate in and benefit
from a pulmonary rehabilitation program, which comprises
administering to the patient a therapeutically effective
amount of a tiotropium salt in conjunction with the patient
participating in a pulmonary rehabilitation program which
includes the patient participating in a sustained exercise
program for improving pulmonary function for a period of
at least 4 weeks,

whereby the administration enhances the benefit to the
patient of the pulmonary rehabilitation program.
The following ground of rejection is before us for review:
Claims 1–8 and 14–21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Liesker,2 Teramoto,3 Barnes,4 and the
BTS Statement.5

2 Liesker et al., A Systematic Review of the Effects of Bronchodilators on
Exercise Capacity in Patients With COPD, 121 CHEST 597–608 (2002).
3 Teramoto et al., Long-Term Effects of Inhaled Anticholinergic Drug on
Lung Function, Dyspnea, and Exercise Capacity in Patients with Chronic
Obstructive Pulmonary Disease, 35 INTERNAL MEDICINE 772–778 (1996).
4 Barnes, Tiotropium bromide, 10(4) EXP. OPIN. INVEST. DRUGS 733–740
(2001).
Appeal 2012-006855
Application 11/468,871

3
ANALYSIS
We have considered Appellants’ arguments that the Examiner errs in
rejecting claim 1 over the combination of Liesker, Teramoto, Barnes, and
the BTS Statement. (App. Br. 4–11; Reply Br. 1–4.) We disagree with
Appellants’ conclusions and adopt as our own the factual findings and well-
reasoned analysis set forth in the Examiner’s Answer. For emphasis, we
briefly summarize the factual underpinning of the Examiner’s determination:
FF1. Liesker reviews the effect of bronchodilators, including
anticholinergics, on exercise capacity in patients with COPD (chronic
obstructive pulmonary disease). (Liesker Title, abstract.) Liesker
states that bronchodilators are associated in improved health outcome
(dyspnea scores) in many patients with COPD “even in the absence of
improvements in level of airflow limitation or exercise capacity.” (Id.
at 604.) Liesker further teaches that the anticholinergic
bronchodilators ipratropium and oxitropium produce significant
improvements in exercise capacity among patients suffering from lung
disease. (Id. at 599.)
FF2. Teramoto, teaches that “the chronic use of an inhaled
anticholinergic bronchodilator [oxitropium bromide] may provide
beneficial improvements in expiratory flow rate, exercise
performance, and dyspnea in mild to moderate COPD patients over
one year.” (Teramoto, abstract.) Teramoto further teaches that
“regular use of [oxitropium bromide] was effective for improvement

5 British Thoracic Society Standards of Care Subcommittee on Pulmonary
Rehabilitation, Statement on Pulmonary Rehabilitation, 56 THORAX 827–
834 (2001).
Appeal 2012-006855
Application 11/468,871

4
in exercise performance and dyspnea in stable COPD patients over a
one-year treatment period.” (Id. at 775.)
FF3. The Examiner finds, and Appellants do not dispute, that
tiotropium is in the same family of anticholinergic bronchodilators as
ipratropium and oxitropium. (Ans. 6.)
FF4. Barnes states that “[t]iotropium bromide is a new long-lasting
anticholinergic drug which, like ipratropium bromide, is a quaternary
ammonium derivative.” (Barnes abstract.) In Phase III studies, once
daily inhaled tiotropium is an effective bronchodilator in COPD
patients, giving great improvement in lung function and reduction in
symptoms. (Id.) “Since, anticholinergics are the bronchodilators of
choice in COPD it is likely that tiotropium bromide will become the
most widely used bronchodilator for COPD patients in the future.”
(Id.)
FF5. The BTS Statement teaches that the aim of pulmonary
rehabilitation programs (PR) “is to reduce disability and handicap in
people with lung disease and to improve their quality of life while
diminishing the health care burden.” (BTS Statement 827.) Although
the vast majority of these patients will have COPD, PR may benefit
“all patients with lung disease whose lifestyle is being adversely
affected by chronic breathlessness.” (Id. at 829.) PR programs
“should contain a minimum of 6 weeks of physical exercise, disease
education, psychological, and social intervention.” (Id. at 828
(Summary of key points).) “Physical aerobic training, particularly of
the lower extremities (brisk walking or cycling), is mandatory.” (Id.)
FF6. The BTS Statement teaches:
Appeal 2012-006855
Application 11/468,871

5
The improvements in health status measurement and
exercise performance following pulmonary rehabilitation
do not appear to be related to each other. Increases in
exercise performance can occur quite quickly, but the
changes in health status may lag behind as patients adjust
to the lifestyle change.
(Id. at 829–830.)
FF7. The BTS Statement further teaches that the optimum duration
of physical training is unknown but improvements in physical
performance may occur by 4 weeks. (Id. at 829.) Outpatient
programs lasting 4–12 weeks have been shown to be effective and one
third of patients may retain significant improvements in health status
after 2 years. (Id. at 830.) In sum, PR programs including prescribed
endurance exercise training should: “Improve functional exercise
capacity;” “Improve health status;” Reduce dyspnoea’” and “Have
some health economic advantages.” (Id. at 829.)
SUMMARY
For the reasons set forth in the Examiner’s Answer, we affirm the
Examiner’s rejection of claim 1 as obvious under 35 U.S.C.
§ 103(a) over the combination of Liesker, Teramoto, Barnes, and the BTS
Statement. Claims 2–8 and 14–21 fall with claim 1.
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
cdc