Ex Parte Gurtner et al

Patent Trial and Appeal Board

Apr 24, 2017

12577006 (P.T.A.B. Apr. 24, 2017)

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.
12/577,006 10/09/2009 Geoffrey C. Gurtner STAN-638 (S08-313) 3315
77974 7590 04/26/2017
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
04/26/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEOFFREY C. GURTNER, JAYAKUMAR RAJADAS,
MICHAEL GABRIEL GALVEZ, and EVGENIOS NEOFYTOU1
Appeal 2017-000716
Application 12/577,006
Technology Center 1600
Before ULRIKE W. JENKS, ROBERT A. POLLOCK, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1, 7—10, 16, 18—20, and 22, 23, and 26—29. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellants’ invention relates to the treatment of chronic wounds by
transdermal delivery of an agent that increases HIF-la activity in the wound.
Spec. 112. Such HIF-la potentiating agents include deferoxamine,
deferiprone, and deferasirox. Id.
1 Appellants identify the real party-in-interest as Leland Stanford Junior
University. App. Br. 1.
Appeal 2017-000716
Application 12/577,006
Claims 1, 22, and 23 are independent. Claim 1 is illustrative
(paragraphing added):
1. A method of treating a chronic skin wound on an
individual, the method comprising:
contacting said wound topically with a transdermal patch
comprising an effective dose of deferoxamine embedded in a
biodegradable polymer film comprising a non-ionic
surfactant,
wherein the transdermal patch comprises an adhesive; and an
impermeable backing membrane;
and wherein an effective dose of the deferoxamine
transdermally penetrates the wound.
STATEMENT OF THE REJECTION
Claims 1, 7—10, 16, 18—20, 22, 23, and 26—29 stand rejected on the
ground of nonstatutory double patenting over claims 34, 45—47, 49-51, 53,
69, and 71—73 of Application No. 11/136,254 (now U.S. Patent No.
8,829,051).
Claims 1, 7—10, 16, 18—20, 22, 23, and 26—29 stand provisionally
rejected on the ground of nonstatutory double patenting over claims 1,5, and
24—28 of copending Application No. 11/297,808.
Claims 1, 7—10, 16, 18—20, 22, 23, and 26—29 stand rejected under
pre-AIA 35 U.S.C. § 103(a) as unpatentable over Gurtner ‘1892 or Gurtner
2 Gurtner and Brownlee, US 2006/0100189 Al, published May 11, 2006.
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Application 12/577,006
’748,3 (collectively, “Gurtner”)4 in view of Roreger,5 Feng,6 Mason,7 and
Lipp.8
DOUBLE PATENTING REJECTIONS
Appellants do not argue the merits of the double patenting rejections.
App. Br. 2. In the absence of substantive arguments, we summarily affirm
the rejections.
REJECTION UNDER 35 U.S.C. § 103(a)
We have reviewed Appellants’ contentions that the Examiner erred in
rejecting claims 1, 7—10, 16, 18—20, 22, 23, and 26—29 as unpatentable over
the cited art. App. Br. 2—9. We disagree with Appellants’ contentions and
adopt the findings of fact and reasoning set forth in the Examiner’s Answer
and the Final Rejection dated January 9, 2015, (“Fin. Rej.”). For emphasis,
we highlight and address the following:
Findings of Fact
FF1. Gurtner is directed to treating or preventing the effects of
hyperglycemia (e.g., promoting the healing of diabetic foot ulcers) by
administering an ROS inhibitor, preferably deferoxamine. See, e.g.,
Gurtner Abstract, || 16, 19-20, 143, claims 1, 9-11, 25. Gurtner teaches
3 Gurtner and Brownlee, US 2006/0281748 Al, published Dec. 14, 2006.
4 Gurtner ’748 represents a continuation of Application No. 11/136,254,
which published as Gurtner ’ 189. Gurtner ’748 and Gurtner ’ 189, thus,
share substantially the same Specification and need not be considered
separately. For convenience, we cite herein to Gurtner ’189.
5 Roreger, US 6,117,437, issued Sept. 12, 2000.
6 Feng et al., US 2007/0104769 Al, published May 10, 2007.
7 Mason, US 2003/0082225 Al, published May 1, 2003.
8 Lipp et al., US 5,676,968, issued Oct. 14, 1997.
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Application 12/577,006
that the ROS inhibitor may be administered transdermally (id. at 174,
claims 32 and 49) and with pharmaceutically acceptable carriers and
excipients (id. at 174, claims 33 and 50). The Examiner reasonably finds
that deferoxamine would transdermally penetrate a wound because
Gurtner “teaches transdermal application to the wound including diabetic
foot ulcers.” Fin. Rej. 8.
FF2. Roreger teaches a pharmaceutical formulation for delivery of an
active agent to a wound comprising a coherent flexible gel sheet with the
active agent homogenously distributed therein. See Roreger Abstract.
The formulation may: contain PVP and ethyl cellulose (id. at 5:60—6:18);
be designed to break down in the wound, i.e., may be biodegradable (id.
at 5:9-43, 60—63); and may include ancillary substances including
nonionic emulsifiers (id. at 6:19-41).
FF3. Feng teaches a bioabsorbable, water-soluble hemostatic cellulose-
based wound dressing, which may include one or more nonionic
surfactants in the range from about 0.1 % to about 5% by weight, and
pharmaceutically active therapeutic agents. Feng Abstract, H 27—28, 37,
43, 45, 49-50, 64—65; see Ans. 4—5.
FF4. Mason discloses an intradermal patch to deliver an active ingredient to
a wound or ulcer having a permeable backing coated with a PVP-based
hydrogel and containing one or more active ingredients. Mason Abstract,
11 10, 22, 34. The patch may further comprise permeation enhancers,
ethyl cellulose, and silicone dioxide. See, e.g., id. H 116, 119—122, 134,
135, 153.
FF5. Fipp discloses a transdermal therapeutic system including an adhesive
matrix comprising, an active ingredient, a crystallization inhibitor and,
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Application 12/577,006
optionally, a penetration enhancer. Lipp Abstract. Lipp teaches ethyl
cellulose, silicone dioxide, and PVP as known crystallization inhibitors.
Id. at 2:1—18.
Analysis
The Examiner finds that it would have been obvious to treat chronic
wounds such as diabetic foot ulcers with a
transdermal formulation comprising [deferoxamine] as
taught by [Gurtner with a] gel taught by Roreger comprising
PVP, ethyl cellulose and nonionic emulsifier as a carrier for
[deferoxamine]. One would have been motivated to do so
because Roreger teaches that PVP combined with ethyl
cellulose provide coherent flexible gel sheet like that delivers
active agent in both rapid release manner and delaye[d]
release manner, and nonionic emulsifier stabilizes the
polymer.
Ans. 10—11. The Examiner similarly finds that it would have been obvious
to treat skin ulcers and other chronic wounds using a patch comprising
deferoxamine in a
polymer carrier comprising combination of PVP, ethyl
cellulose and nonionic emulsifier as taught by [Gurtner]
combined with Roreger, and Feng. . . . One having ordinary
skill in the art would have been motivated to deliver
[deferoxamine] in the transdermal patch taught by Mason
comprising backing layer and adhesive because Mason
teaches such a patch is stable and secure to the skin. One
would have been motivated to add permeation enhancer and
crystallization inhibitor to the patch to improve the delivery
of the [deferoxamine] and any other active agent in the patch
and meanwhile maintain them un-crystallized.
Id. at 12.
Appellants respond that “[w]hile hydrophobic drugs can readily pass
through the skin and tend to aggregate in the local adipose tissue,
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hydrophilic drugs such as deferoxamine, do not readily pass through the
skin, and tend to systemically distribute via the vasculature.” App. Br. 4
(emphasis removed). In the present case, Appellants argue, the rejection is
in error because the appealed claims include a non-ionic surfactant that
enables transdermal delivery of deferoxamine by creating a reverse-micellar
conformation and inhibiting crystallization. Id. at 4—5. According to
Appellants, “[t]he reverse micelle technology achieved by the present
formulation allows the local, transdermal delivery of this hydrophilic drug.”
Id. at 4.
Appellants further argue that “[although use of [deferoxamine] was
desirable, it is not straightforward or obvious how to specifically enable
transdermal penetration at a therapeutically useful level. A significant block
to formulation has been crystallization of the active agent.” Id. at 5. For
example, “when 5% DMSO was included in the formulation, as is normally
done to increase transdermal delivery, it was found to inhibit [deferoxamine]
delivery.” Id. Appellants present figures purporting to represent
experimental data demonstrating the unexpected results achieved with the
claimed formulation. See id. at 6—7.
As noted by the Examiner, however, Lipp teaches ethyl cellulose and
PVP as known crystallization inhibitors, whereas the reverse-micelle
configuration is not a limitation of the claims on appeal. See Ans. 5, 8.
Moreover, nowhere do we discern any discussion of reverse micelles in the
Specification, nor evidence that the permeation enhancer DMSO should be
excluded from the formulation—to the contrary, both the Specification and
the appealed claims appear to encompass the use of DMSO. See Spec. 1 58
(“the formulation comprises permeation enhancer, e.g. . . . dimethylsulfoxide
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(DMSO). . . at a weight/weight concentration of from about 0.1 % to about
10%”); claim 19 (“wherein the biodegradable polymer film further
comprises a permeation enhancer”).
Further, with respect to the purported evidence of unexpected results,
Appellants have not provided sufficient evidence by way of declaration or
other means to support this position. Nor have Appellants indicated where
this evidence is found in the Specification, or included a citation to a
published article. Accordingly, we agree with the Examiner that Appellants’
arguments regarding the exclusion of DMSO are based on opinion evidence,
which is entitled to little or no weight. See Ans. 4. Mere lawyer’s
arguments and conclusory statements, which are unsupported by factual
evidence, are entitled to little probative value. In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997). Attorney argument is not evidence. In re Pearson,
494 F.2d 1399, 1405 (CCPA 1974). Nor can it take the place of evidence
lacking in the record. Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977).
Based on the record before us, we agree with the Examiner that,
“[e]ach [of the] elements of the instantly claimed method, steps or
ingredients, are taught by combination of the cited references, and any
reverse micelle formation or prevention of crystallization or enhancement of
penetration is expected from the prior art method and dressing.” Ans. 6. We
conclude that the Examiner has established a prima facie case of
obviousness, which, on the existing record, Appellants have not rebutted.
SUMMARY
We affirm the rejection of claims 1, 7—10, 16, 18—20, 22, 23, and 26—
29 under pre-AIA 35 U.S.C. § 103(a) as unpatentable over the combination
of Gurtner, Roreger, Feng, Mason, and Lipp.
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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) (l)(iv).
AFFIRMED
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