Ex Parte Ljunggren et al

Patent Trial and Appeal Board

May 13, 2013

11911726 (P.T.A.B. May. 13, 2013)

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.
11/911,726 10/17/2007 Anders Ljunggren 133087.21901(101743-1PUS) 1687
52286 7590 05/13/2013
Pepper/AstraZeneca
400 Berwyn Park
899 Cassatt Road
Berwyn, PA 19312-1183
EXAMINER
FINN, MEGHAN R
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
05/13/2013 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 ANDERS LJUNGGREN and PETER MORSING
__________

Appeal 2012-000327
Application 11/911,726
Technology Center 1600
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
combination of pharmaceutically active compounds. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification discloses that “inhibitors of renin or ACE, as well
as antagonists of AII receptors, have found utility in the treatment of
hypertension” (Spec. 1:29-31) and that “compounds such as candesartan (an
Appeal 2012-000327
Application 11/911,726

2
AII receptor antagonist having selectivity for AT1 receptors) have been
demonstrated to be particularly effective antihypertensive agents” (id. at 2:1-
3). The Specification also discloses that nitric oxide is “a powerful
vasodilator” (id. at 1:25-26) and that “[t]etrahydrobiopterin (BH4) is … a
cofactor for all three isoforms of nitric oxide synthase” (id. at 2:14-16). The
Specification discloses that “BH4 has recently been identified as a potential
therapeutic target in the regulation of endothelial nitric oxide synthase
function in vascular disease” (id. at 2:29-31).
Claims 1, 3-5, 7-12, and 14-17 are on appeal. Claim 1 reads as
follows:
1. A combination product comprising:
(A) BH4 or a compound of formula I,

wherein [R
1
through R
6
are chosen from specified groups]; and
(B) an inhibitor chosen from a renin inhibitor, an ACE inhibitor or an
AT1 receptor antagonist,
wherein each of components (A) and (B) is formulated in admixture
with a pharmaceutically-acceptable adjuvant, diluent or carrier.

Independent claim 3 is similar to claim 1 except that it is directed to a
kit comprising pharmaceutical formulations comprising the same two
components.
Appeal 2012-000327
Application 11/911,726

3
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as obvious in view of Hong
1
and Shimizu.
2
The Examiner finds
that the claims read on a combination product or a kit comprising BH4 and
candesartan, the elected species of the claimed inventions (Answer 5, 6).
The Examiner finds that Hong discloses that “BH4 can prevent the
development of endothelial dysfunction and hypertension” (id. at 5), and that
Shimizu discloses that “candesartan cilexetil, a common salt form of
candesartan, is useful for treatment and prevention of hypertension” (id. at
6). The Examiner concludes that it would have been obvious the two drugs
because they are both known for treatment or prevention of hypertension
(id.). We agree with the Examiner that Hong and Shimizu support a prima
facie case of obviousness.
Appellants argue, however, that they have provided evidence showing
that the combination of BH4 and candesartan cilexetil unexpectedly reduces
the mortality of rats with induced hypertension (Appeal Br. 14-15).
The Examiner acknowledges that Appellants have “demonstrated
unexpected results with respect to mortality” for the combination of 10
mg/kg BH4 with 5 mg/kg candesartan (Answer 8-9). The Examiner finds,
however, that results are not commensurate in scope with the claims because
the unexpected results were shown only for a single dosage each of BH4 and
candesartan, and “the claims encompass … any dosage of BH4 and any
dosage of candesartan” (id. at 9). The Examiner also reasons that the claims

1
Hong et al., Supplementation With Tetrahydrobiopterin Suppresses the
Development of Hypertension in Spontaneously Hypertensive Rats, 38
HYPERTENSION 1044-1048 (2001).
2
Shimizu et al., US 6,299,904 B1, issued Oct. 9, 2001.
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Application 11/911,726

4
are not limited to BH4 and candesartan but “encompass a multitude of
different compounds for formula I and several different classes of
compounds for the inhibitor” (id.).
The Examiner’s reasoning is not persuasive. “If an applicant
demonstrates that an embodiment has an unexpected result and provides an
adequate basis to support the conclusion that other embodiments falling
within the claim will behave in the same manner, this will generally
establish that the evidence is commensurate with [the] scope of the claims.”
In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
Here, the Specification discloses that the compounds of formula I are
functional derivatives of BH4 or biosynthetic precursors of BH4 (Spec. 4:30
to 7:4). The Specification also discloses that renin inhibitors, ACE
inhibitors, and AT1 receptor antagonists have all found utility in the
treatment of hypertension because they inhibit the synthesis or function of
angiotensin II (id. at 1:29-31). The Specification thus provides a reasonable
basis to expect that other inhibitors of the renin-angiotensin system would
function similarly to candesartan, and that other Formula I compounds
would function similarly to BH4.
The Examiner has not provided any persuasive evidence or technical
reasoning to show that other active ingredient combinations encompassed by
the claims would be expected to show significantly different properties than
the combination of BH4 and candesartan. Nor has the Examiner provided a
reasonable basis for concluding that different dosages of BH4 and
candesartan would be expected to be non-synergistic. Thus, we find that the
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Application 11/911,726

5
Examiner has not adequately explained why the demonstrated unexpected
results are not commensurate in scope with the inventions of the claims.
SUMMARY
We reverse the rejection of claims 1, 3-5, 7-12, and 14-17 under 35
U.S.C. § 103(a).

REVERSED

cdc