Ex Parte Surwit et al

Board of Patent Appeals and Interferences

Sep 15, 2010

11584005 (B.P.A.I. Sep. 15, 2010)

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.
11/584,005 10/20/2006 Richard S. Surwit MJW-1579-1144 3178
23117 7590 09/16/2010
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
WEDDINGTON, KEVIN E
ART UNIT PAPER NUMBER
1614
MAIL DATE DELIVERY MODE
09/16/2010 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 RICHARD S. SURWIT and SHEILA A. COLLINS
__________

Appeal 2010-004714
Application 11/584,005
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-5.

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.
Appeal 2010-004714
Application 11/584,005

2
We have jurisdiction under 35 U.S.C. § 6(b).

STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. A method of increasing the sensitivity of a hyperinsulinemic patient to
the anti-obesity and antidiabetic effects of a β adrenergic receptor (βAR)
agonist comprising administering to said patient said βAR agonist and an
agent that reduces plasma insulin levels, wherein said agent is a KATP
channel agonist, under conditions such that said increase is effected.

The following ground of rejection is before us for review:
Claims 1-5 stand rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Bloom2 and Vardi.3 (Ans. 4.)
We affirm.
ISSUE
Has the Examiner established by a preponderance of the evidence that
the combination of Bloom and Vardi renders obvious a method of
administering a βAR agonist and a KATP channel agonist to a
hyperinsulinemic patient?

FINDINGS OF FACT
FF1 The Examiner’s statement of the rejection may be found at pages 4-5
of the Answer. As Appellants have not argued the claims separately, we

2 Bloom, US 5,061,727, issued Oct. 29, 1991.
3 Vardi, US 6,197,765 B1, issued Mar. 6, 2001.
Appeal 2010-004714
Application 11/584,005

3
focus our analysis on claim 1, and claims 2-5 stand or fall with that claim.
37 C.F.R. § 41.37(c)(1)(vii).
FF2 Specifically, the Examiner finds that Bloom teaches a βAR agonist,
i.e., substituted 5-(2-((aryl-2-hydroxyethyl)amino)-propyl)-1,3-
benzodioxoles, “possess anti-diabetic and/or anti-hyperglycemic and/or anti-
obesity properties in humans and other animals.” (Ans. 4.)
FF3 The Examiner notes that Bloom does not teach the addition of the
administration of a KATP channel agonist. (Id.)
FF4 The Examiner relies on Vardi for teaching the administration of a
KATP channel agonist, i.e., diazoxide, to patients suffering from diabetic
complications such as Syndrome Z. (Id.)
FF5 The Examiner further finds that Vardi teaches that diazoxide inhibits
the release of insulin and proinsulin. (Id.) The Examiner further finds that
Vardi teaches that diazoxide may used in weight reduction. (Id.)
FF6 The Examiner concludes that the ordinary artisan would have
modified the method of Bloom and also administer the diazoxide of Vardi,
which has insulin and weight lowering effects, to aid in the diabetic and
obesity treatment methods of Bloom. (Ans. 5.)

PRINCIPLES OF LAW
As the Supreme Court pointed out in KSR Int'l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
Appeal 2010-004714
Application 11/584,005

4
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
While holding that some rationale must be supplied for a conclusion
of obviousness, the Supreme Court nonetheless rejected a “rigid approach”
to the obviousness question, and instead emphasized that “[t]hroughout this
Court’s engagement with the question of obviousness, our cases have set
forth an expansive and flexible approach . . . .” Id. at 415. The Court also
rejected the use of “rigid and mandatory formulas” as being “incompatible
with our precedents.” Id. at 419; see also id. at 421 (“Rigid preventative
rules that deny factfinders recourse to common sense, however, are neither
necessary under our case law nor consistent with it.”).
The Court thus reasoned that the analysis under 35 U.S.C. § 103 “need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418; see
also id. at 421 (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”)

Appeal 2010-004714
Application 11/584,005

5
ANALYSIS
Appellants argue that as acknowledged by the Examiner, Bloom does
not teach the administration of a KATP channel agonist, asserting further that
Bloom “is also utterly devoid of any suggestion of administering such an
agonist to increase the sensitivity of a hyperinsulinemic patient to the anti-
obesity and anti-diabetic effects of a βAR agonist.” (App. Br. 11.)
Appellants also assert that Vardi does not remedy the deficiencies of Bloom
as, Vardi does not teach administration of a βAR agonist, and is also “devoid
of any suggestion of administering diazoxide and a βAR agonist to a
hyperinsulinemic patient to increase the anti-obesity and anti-diabetic effects
of the βAR agonist.” (Id.)
Appellants assert that the Examiner has thus relied upon improper
hindsight in combining the references to arrive at the claimed invention. (Id.
at 12.) Appellants also argue that there is no reasonable expectation of
success, as “there is nothing in the cited art that would have suggested that
administration to a hyperinsulinemic patient of a βAR agonist and a KATP
channel agonist would increase the sensitivity of that patient to the anti-
obesity and anti-diabetic effects of the βAR agonist.” (Id.)
Appellants’ arguments are not convincing. Claim 1 requires
administering to a hyperinsulinemic patient, such as a patient suffering from
diabetes or obesity, a βAR agonist and a KATP channel agonist. As found by
the Examiner, and undisputed by Appellants, Bloom teaches that βAR
agonists possess anti-diabetic and anti-obesity properties, and Vardi teaches
administering diazoxide, a KATP channel agonist, to patients suffering from
diabetic complications and to help aid in weight reduction. Thus, in view of
Appeal 2010-004714
Application 11/584,005

6
the above teachings, we agree it would have been prima facie obvious to
administer both a βAR agonist and a KATP channel agonist to a
hyperinsulinemic patient, such as a patient suffering from diabetes or
obesity.
This type of reason to combine has been recognized often by the
predecessor of our reviewing court, which has held that it is prima facie
obvious to combine two compositions each of which is taught by the prior
art to be useful for the same purpose, in order to form a third composition
which is to be used for the same purpose. In re Susi, 440 F.2d 442, 445
(CCPA 1971); In re Crockett, 279 F.2d 274, 276-77 (CCPA 1960). “[T]he
idea of combining them flows logically from their having been individually
taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Here the art recognized properties of each of the described agents in treating
obesity and diabetes would have provided one of ordinary skill in the art
with ample suggestion of their combination in the composition as claimed.
KSR, 550 U.S. at 416 (“The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.”).
As to Appellants’ arguments that neither of the references teaches or
suggests administering both a βAR agonist and a KATP channel agonist, the
rejection is based on obviousness, and not anticipation, and as set forth
above, we agree with the Examiner that the references as combined suggest
administering both a βAR agonist and a KATP channel agonist to a
hyperinsulinemic patient. As to the argument that the references do not
teach or suggest that administration of a βAR agonist and a KATP channel
Appeal 2010-004714
Application 11/584,005

7
agonist to a hyperinsulinemic patient would increase the sensitivity of that
patient to the anti-obesity and anti-diabetic effects of the βAR agonist, that
would be an inherent result of the administration of the combination of
agents. To the extent that Appellants appear to be arguing that the
administration of the combination provides unexpected results, Appellants
have not provided any evidence of such.

CONCLUSION OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that the combination of Bloom and Vardi renders obvious a
method of administering a βAR agonist and a KATP channel agonist to a
hyperinsulinemic patient. We thus affirm the obviousness rejection.

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)(1)(iv)(2006).

AFFIRMED

cdc
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203