Ex Parte Dietzel et al

Patent Trial and Appeal Board

Oct 31, 2012

10559383 (P.T.A.B. Oct. 31, 2012)

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.
10/559,383 12/06/2005 Klaus Dietzel 27072U 3631
34375 7590 10/31/2012
NATH & ASSOCIATES PLLC
112 South West Street
Alexandria, VA 22314
EXAMINER
ALSTRUM ACEVEDO, JAMES HENRY
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
10/31/2012 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KLAUS DIETZEL and HELGERT MUELLER
__________

Appeal 2011-012755
Application 10/559,383
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
pharmaceutical suspension formulation comprising particles of R, R-
formoterol and ciclesonide, or pharmaceutically acceptable salts thereof, as
the sole active ingredients. The Patent Examiner rejected the claims as
obvious and on the ground of non-statutory obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

Appeal 2011-012755
Application 10/559,383

2
STATEMENT OF THE CASE
Claims 1-4 and 6-11 are on appeal. Independent claim 1 is
representative and reads as follows:
1. A pharmaceutical suspension formulation comprising
a. as a first active ingredient, particles of R,R-formoterol or a
pharmaceutically acceptable salt thereof, said particles being
suspended in the formulation,
b. as a second active ingredient, particles of ciclesonide or a
pharmaceutically acceptable salt thereof, said particles being
suspended in the formulation, and
c. a propellant selected from the group consisting of 1,1,1,2-
tetrafluoroethane, 1,1,1,2,3,3,3-heptafluoropropane and a
mixture thereof,
wherein said first active ingredient and said second active ingredient are the
sole active ingredients in said pharmaceutical suspension formulation, and
are readily dispersible, and upon redispersion do not flocculate as to prevent
reproducing dosing of said first active ingredient and/or said second active
ingredient.

The Examiner rejected the claims as follows:
• claims 1, 3-4, 6, 9 and 11 under 35 U.S.C. § 103(a) as unpatentable
over Aberg,
1
Burt,
2
Garcia-Marcos
3
and Calatayud;
4

• claims 2 and 7-8 under 35 U.S.C. § 103(a) as unpatentable over
Aberg, Burt, Garcia-Marcos, Calatayud and Fassberg;
5

1
US Patent No. 5,795, 564 issued to Gunnar Aberg et al., Aug. 18, 1998.
2
Patent Application Publication No. US 2002/0030068 A1 by Peter Colin
Weston Burt, published Mar. 14, 2002.
3
Luis Garcia-Marcos et al., Inhaled corticosteroids plus long-acting β2-
agonists as a combined therapy in asthma, 4 EXPERT OPIN.
PHARMACOTHER., 23-39 (2003).
4
US Patent No. 5,482,934 issued to Jose Calatayud et al., Jan. 9, 1996.
5
US Patent No. 5,474,759 issued to Julianne Fassberg et al., Dec. 12, 1995.
Appeal 2011-012755
Application 10/559,383

3
• claims 1, 3, 9 and 11 under 35 U.S.C. § 103(a) as unpatentable over
Gavin
6
and Calatayud;
• claims 2, 4, 7 and 8 under 35 U.S.C. § 103(a) as unpatentable over
Gavin, Calatayud and Fassberg;
• claims 2, 4, 7-8 and 10 under 35 U.S.C. § 103(a) as unpatentable
over Gavin, Calatayud and Keller.
7

• claim 1 on the ground of non-statutory obviousness-type double
patenting as unpatentable over claim 6 of US Patent Application
10/537,356,
8
in view of Burt and Aberg.

OBVIOUSNESS
I. The Rejections over Aberg, Burt, Garcia-Marcos, and Calatayud
The Examiner found that Aberg taught a metered dose inhaler
containing a suspension formulation comprising R,R-formoterol fumarate
dehydrate, a trichloromonofluoromethane propellant, a
dichlorodifluoromethane propellant, and a sorbitan trioleate surfactant.
(Ans. 7.) The Examiner also found that Aberg taught that R,R-formoterol
may be used in combination with other therapeutic ingredients and may be
formulated into various forms such as suspensions, which may be
administered by inhalation. (Id.) However, the Examiner found that Aberg
did not teach a composition comprising formoterol and ciclesonide or a

6
Patent Application Publication No. WO 01/78738 A1 by Brian Gavin,
published Oct. 25, 2001.
7
Patent Application Publication No. WO 00/07567 A1 by Manfred Keller et
al., published Feb. 17, 2000.
8
US Patent Application No. 10/537,356 issued as Patent No. US 7,879,833
B2 to Christian Weimer et al., Feb. 1, 2011. (App. Br. 20; Ans. 28.)
Appeal 2011-012755
Application 10/559,383

4
suspension aerosol formulation comprising one of the specific propellants
recited in the claimed invention. (Id. at 9.)
The Examiner found that Burt taught that chlorofluorocarbon
propellants are being phased out in pharmaceutical formulations because
they deplete the ozone layer and suitable alternatives exist, including
1,1,1,2-tetrafluoroethane and 1,1,1,2,3,3,3-heptafluoropropane. (Id. at 7.)
The Examiner also found that Burt identified several active agents that may
be formulated into pharmaceutical compositions in the form of solution or a
suspension in combination with the alternative propellants, including anti-
inflammatory agents such as budesonide, fluticasone, and flunisolide, and
bronchodilators, such as formoterol. (Id.)
The Examiner found that Garcia-Marcos taught that the combination
of a long-acting beta-2 agonist (e.g., formoterol or salmeterol) with an
inhaled corticosteroid in the same inhaler is as effective as administering a
much higher dosage of the inhaled corticosteroid alone for the control of
asthma in patients with asthma that is not well controlled with an inhaled
corticosteroid alone, while decreasing the likelihood of side effects from the
inhaled corticosteroid. (Id. at 8.) The Examiner also found that Garcia-
Marcos taught that the combination of formoterol and budesonide was found
to improve lung function and asthma control as compared to budesonide
alone. (Id.)
The Examiner found that Calatayud taught that ciclesonide is
desirable for the treatment of inflammatory conditions because it has a
greater therapeutic index than other commonly administered anti-
inflammatory steroids, e.g., budesonide. (Id.)
Appeal 2011-012755
Application 10/559,383

5
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 have modified
Aberg’s composition comprising R,R-formoterol to include ciclesonide as a
second therapeutic agent in the composition because: (a) Aberg taught that
its composition may comprise another therapeutic agent; (b) Garcia-Marcos
taught the beneficial combination of formoterol with budesonide, and (c)
Calatayud taught that ciclesonide has a better profile than budesonide. (Id.
at 9.) Additionally, the Examiner concluded that it would have been obvious
for the artisan to substitute one of the alternative propellants disclosed by
Burt for Aberg’s propellant, which Burt taught was being phased out due to
its harmful effects on the ozone layer. (Id.)
Appellants contend that Aberg did not teach or suggest the claimed
invention because it was “absolutely silent regarding the presently claimed
formulation comprising particles of R,R-formoterol and ciclesonide as the
sole active ingredients ….” (App. Br. 12.) Appellants assert that none of
Burt, Garcia, or Calatayud remedied the deficiencies of Aberg because each
of these references, separately, also failed to teach or suggest the
combination of R,R-formoterol and ciclesonide as the sole active ingredients
in a pharmaceutical suspension formulation. (Id. at 13.) According to
Appellants, “upon reading the combined teachings of the cited references, a
person of ordinary skill in the art would not be motivated to prepare the
presently claimed subject matter.” (Id. at 14.) Additionally, regarding the
rejection including Fassberg, Appellants assert that this reference does not
remedy the deficient teaching of Aberg, Burt, Garcia-Marcos and Calatayud.
(Id. at 15.)
Appeal 2011-012755
Application 10/559,383

6
After considering all the evidence and arguments, we conclude that the
record supports a conclusion of prima facie obviousness for the reasons
discussed by the Examiner, namely, that a skilled artisan would have been
motivated to modify Aberg’s formulation to include ciclesonide as the
second active agent based on the combined teachings of Aberg, Garcia-
Marcos and Calatayud. (Ans. 9-10.) The Examiner articulated reasoning
with rational underpinnings to support a motivation to combine the prior art
teachings. See 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). Appellants
have not established otherwise by attacking the references separately and
then merely asserting that “upon reading the combined teachings of the cited
references, a person of ordinary skill in the art would not be motivated to
prepare the presently claimed subject matter.” (App. Br. 14.)
Accordingly, we affirm the obviousness rejections over the
combinations including Aberg, Burt, Garcia-Marcos and Calatayud.
II. The Rejections over Gavin and Calatayud
The Examiner found that Gavin taught medicinal compositions
comprising R,R-formoterol and rofleponide (a corticosteroid) for the
treatment of respiratory diseases, such as asthma. (Ans. 13.) The Examiner
also found that Gavin taught that its formulation may additionally comprise
therapeutic agents, such as anti-inflammatory agents, e.g., budesonide,
beclomethasone, triamcinolone, etc., or NSAIDS. (Id. at 14.) Additionally,
the Examiner found that Gavin taught inhalable formulations including a
propellant, such as 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-
heptafluoropropane, or mixtures thereof. (Id.) The Examiner also found
Appeal 2011-012755
Application 10/559,383

7
that Gavin did not teach formulations comprising ciclesonide. (Id.)
However, the Examiner found that Calatayud cured this deficiency. (Id.)
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 have replaced
rofleponide in Gavin’s formulation with ciclesonide, because Calatayud
taught that ciclesonide has a greater therapeutic index than other
conventional anti-inflammatory corticosteroids. (Id.)
Appellants contend that Gavin requires the presence of the active
ingredient rofleponide in its formulation, and therefore, cannot render the
presently claimed invention obvious because it does not teach a
pharmaceutical suspension formulation comprising only R,R-formoterol and
ciclesonide as the sole active ingredients. (App. Br. 17-20.)
We agree with Appellants that the Examiner has not established that
the rejected claims are rendered obvious over combinations including Gavin
and Calatayud. As Appellants assert, Gavin required an active agent other
than the first and second active ingredients recited in the claimed invention
as the sole active ingredients. Moreover, while the Examiner’s modification
of Gavin involved substituting rofleponide with ciclesonide, we do not find
that the Examiner articulated reasoning with a rational underpinning to
support a motivation to combine the teachings of Gavin and Calatayud. In
particular, Calatayud did not compare ciclesonide with rofleponide so as to
provide a skilled artisan with a motivation to substitute the former active
agent for the latter active agent. Accordingly, we reverse the rejections over
combinations including Gavin and Calatayud.
Appeal 2011-012755
Application 10/559,383

8

OBVIOUSNESS-TYPE DOUBLE PATENTING
The Examiner’s position is that the differences between claim 1 of the
instantly claimed invention and claim 6 of US Patent Application No.
10/537,356, issued as claim 1 of Patent No. US 7,879,833 B2 (“Weimer”)
(App. Br. 20; Ans. 28) do not render the claims patentably distinct when
claim 1 of Weimer is considered in view of the teachings of Aberg and Burt.
(Ans. 21-22.)
In their Appeal Brief, Appellants reproduce the disputed claims and
merely assert that “[i]n view of the clearly divergent scopes of the claims at
issue, Appellants respectfully submit that issuance of presently pending
claim 1 would not be an unjustified or improper timewise extension of the
right to exclude granted by claim 6 of the `833 patent.” (App. Br. 21.)
Appellants have not addressed the teachings of Aberg and Burt which the
Examiner combined in the obviousness-type double patenting rejection.
Therefore, we are not persuaded by Appellants’ argument that the instant
claim 1 and Weimer claim 1, in view of Aberg and Burt, are patentably
distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed Cir.
2001).
Accordingly, we affirm the obviousness-type double patenting
rejection.

SUMMARY
We affirm the rejection of claims 1, 3-4, 6, 9 and 11 under 35 U.S.C.
§ 103(a) as unpatentable over Aberg, Burt, Garcia-Marcos and Calatayud;
Appeal 2011-012755
Application 10/559,383

9
we affirm the rejection of claims 2 and 7-8 under 35 U.S.C. § 103(a)
as unpatentable over Aberg, Burt, Garcia-Marcos, Calatayud and Fassberg;
we reverse the rejection of claims 1, 3, 9 and 11 under 35 U.S.C. §
103(a) as unpatentable over Gavin and Calatayud;
we reverse the rejection of claims 2, 4, 7 and 8 under 35 U.S.C. §
103(a) as unpatentable over Gavin, Calatayud and Fassberg;
we reverse the rejection of claims 2, 4, 7-8 and 10 under 35 U.S.C. §
103(a) as unpatentable over Gavin, Calatayud and Keller;
we affirm the rejection of claim 1 on the ground of non-statutory
obviousness-type double patenting as unpatentable over claim 6 of US
Patent Application 10/537,356, in view of Burt and Aberg.

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

alw