Ex Parte Jaffe et al

Patent Trials and Appeals Board

Mar 28, 2019

13469481 - (D) (P.T.A.B. Mar. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/469,481 05/11/2012
86738 7590 04/01/2019
MCCARTER & ENGLISH, LLP BOSTON
265 Franklin Street
Boston, MA 02110
FIRST NAMED INVENTOR
Mike Jaffe
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
123328-00104 1084
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
04/01/2019 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@mccarter.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MIKE JAFFE, GARY COOK, PERRY CALIAS, and
MICHAEL A. PATANE
Appeal2018-001990
Application 13/469,481 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejections of claim 29. We have jurisdiction under 35 U.S.C.
§ 6(b).
For the reasons set forth below, we REVERSE.
1 Appellants identify the real party in interest as Eyegate Pharmaceuticals,
Inc. Appeal Br. 4.
Appeal2018-001990
Application 13/469,481
BACKGROUND
The Specification describes devices and methods for using
iontophoresis2 to deliver dexamethasone phosphate into the eye, and related
formulations. See Spec. 3 :2-10. Only claim 29 is pending:
29. An aqueous dexamethasone phosphate formulation
comprising: (1) dexamethasone phosphate at a concentration of
40 mg/mL; and (ii) a buffering agent, wherein said buffering
agent adjusts the pH of said formulation to 5.7 to 5.8.
Appeal Br. 32 (Claim Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claim 29 stands rejected under 35 U.S.C. § I03(a) (pre-AIA) as
unpatentable over JP '769 3 and Penfold. 4 Ans. 3.
2. Claim 29 stands rejected under 35 U.S.C. § I03(a) (pre-AIA) as
unpatentable over Samson. 5 Ans. 4.
DISCUSSION
A. Rejection 1
The Examiner relies on JP '769 as teaching a composition comprising
dexamethasone and a buffer (wherein the pH is preferably about 3.5-6) for
ophthalmologic use. Final Action 4 (citing JP '769 claims 5, 15, ,r 18). JP
'769 further provides that exemplary forms of dexamethasone for use in the
2 "The process of iontophoresis involves applying a current to an ionizable
substance, for example a drug product, to increase its mobility across a
surface." Spec. 6:17-18.
3 JP 2006-518769, published Aug. 17, 2006 (English translation, of record).
4 Penfold et al., US 2005/0245497 Al, published Nov. 3, 2005.
5 Samson et al., US 2007 /0219170 Al, published Sept. 20, 2007.
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Application 13/469,481
composition include dexamethasone alcohol, dexamethasone acetate, or
dexamethasone sodium phosphate. See id. (citing JP '769 ,r 12). Because JP
'7 69 is silent as to the concentration of its disclosed forms of
dexamethasone, the Examiner turns to Penfold. See id. Penfold also
describes compositions for ophthalmologic use, including dexamethasone, 6
including at a range of about 40 mg/ml. 7 See id. ( citing Penfold ,r,r 142,
159). The Examiner concludes that the ordinarily skilled artisan would have
been motivated to administer the dexamethasone sodium phosphate
composition of JP '769 at a concentration of 40 mg/ml as taught in Penfold
"because the dexamethasone concentration is known to be therapeutically
effective and safe for ophthalmic use, per the teachings of Penfold et al." Id.
at 5.
Appellants proffer rebuttal evidence, arguing that the pH range (5.7-
5.8) and concentration (40 mg/ml) recited in claim 29 are critical to
overcoming the problem of the prior art, i.e., ocular lesions associated with
iontophoresis, and that this result is unexpected. See Appeal Br. 14--16. In
support, Appellants present evidence from animal studies and clinical trials.
See generally id. at 7-13 ( citing First Patane Deel., 8 Second Patane Decl.,9
6 Though not cited in the Final Action, Penfold also specifically discloses
dexamethasone sodium phosphate. See, e.g., Penfold ,r,r 140, 3 51.
7 More specifically, "about 40 mg/ml" is the top end of the concentration
range disclosed in Penfold. See Penfold ,r 159.
8 Declaration of Michael A. Patane, Ph.D., under 37 C.F.R. § 1.132, dated
Nov. 7, 2012.
9 Declaration of Michael A. Patane, Ph.D., under 37 C.F.R. § 1.132, dated
Oct. 4, 2013.
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Application 13/469,481
Y ewey Deel. 10). Appellants' proffered evidence indicates: (1) iontophoretic
administration of dexamethasone phosphate to rabbit eyes did not cause
retinal lesions at 40 mg/ml, but did cause retinal lesions at 60 mg/ml (see
First Patane Deel. ,r,r 34--36); (2) iontophoretic administration of
dexamethasone phosphate to rabbit eyes, at pH 5.7-5.8, did not cause ocular
toxicity at 25 mg/ml, but did cause ocular toxicity at 50 mg/ml (see Y ewey
Deel. ,r 6); (3) a solution of dexamethasone phosphate at 40 mg/ml at an
initial pH of 5. 7 offered the greatest buffering capacity when current
appropriate for iontophoresis was applied, whereas initial pH values of 7 .2
and 8.0 resulted in rapid pH rises (see Second Patane Deel. ,r 6); ( 4) a
solution of dexamethasone phosphate at 10 mg/ml at an initial pH of 7 .2
underwent rapid pH increase when current used in iontophoresis was applied
(see id.); (5) in two separate clinical trials, iontophoretic administration of a
dexamethasone phosphate 40 mg/ml buffered solution, with a starting pH of
5.7, was well tolerated, and produced significant improvements in patients'
ocular disorders without causing safety concerns or severe adverse effects
(see First Patane Dec. ,r,r 40-43).
The Examiner does not take issue with the quality of the evidence
presented in the declarations. See generally Ans. 6-11. Rather, the
Examiner states that the evidence is not commensurate in scope with claim
29, because "[t]here are no limitations in the instant claims that would limit
the composition to a composition administered by iontophoresis." Id. at 10-
11. However, claim 29 is drawn to a formulation of dexamethasone
10 Declaration of Gary Yewey, Ph.D., under 37 C.F.R. § 1.132, dated March
9, 2016.
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Application 13/469,481
phosphate, not a method for administering it. See In re Papesch, 315 F.2d
381,391 (CCPA 1963) ("From the standpoint of patent law, a compound
and all of its properties are inseparable; they are one and the same thing.").
The issue before us is not intended use, then, but critical range:
In general, an applicant may overcome a prima facie case of
obviousness by establishing that the [ claimed] range is critical,
generally by showing that the claimed range achieves
unexpected results relative to the prior art range .... That same
standard applies when, as here, the applicant seeks to optimize
certain variables by selecting narrow ranges from broader
ranges disclosed in the prior art.
In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (quotation and
citations omitted) (brackets in original). Consistently, in In re Chupp, 816
F.2d 643 (Fed. Cir. 1987), the court found that although the superiority of a
claimed herbicide had only been shown for two crops, but not all crops, the
court still considered this evidence sufficient to establish patentability of the
claimed compound. The Chupp court concluded that "[t]here is no set
number of crops on which superiority must be shown," id. at 647, and
explained more generally that "[ e ]vidence that a compound is unexpectedly
superior in one of a spectrum of common properties, as here, can be enough
to rebut a prima facie case of obviousness," id. at 646 ( citation omitted).
Here, Appellants have proffered evidence that (1) prior attempts to
iontophoretically administer dexamethasone phosphate led to unacceptable
side effects, such as retinal lesions (see generally Appeal Br. 5---6 ( discussing
Lam 11)), and (2) unexpectedly (see First Patane Deel. ,r 43), Appellants
11 Tim T. Lam et al., A histopathologic study of retinal lesions inflicted by
transscleral iontophoresis, 229 GRAEFE'S ARCHIVE CLIN. EXP.
0PHTHALMOL. 389-94 (1991).
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Application 13/469,481
discovered dexamethasone phosphate could be administered
iontophoretically without causing retinal lesions or other significant safety
concerns, if used at the specific concentration and pH range reflected in
claim 29. Whether we consider this rebuttal evidence through the lens of
solving a long-felt need in the art or as unexpected results, we find that
Appellants have met their burden of rebutting the Examiner's prima facie
case of obviousness by establishing that the claimed range is critical, thus
distinguishing claim 29 as nonobvious over the wider ranges disclosed in the
cited prior art. We note that the scope of these unexpected results is
commensurate with the narrow focus of claim 29 on a specific
dexamethasone phosphate concentration of 40 mg/ml in a buffer at a pH
between 5.7 and 5.8. Accordingly, we reverse Rejection 1.
B. Rejection 2
For Rejection 2, the Examiner finds that Samson teaches a
composition comprising dexamethasone in the form of dexamethasone
sodium phosphate, at a concentration of 12.5 mg/ml-250 mg/ml and at pH
5.7-5.9. See Ans. 5 (citing Samson ,r,r 17, 59, claim 39). Appellants
respond to Rejection 2 by relying on the same rebuttal evidence as for
Rejection 1, i.e., to show that the concentration and pH range recited in
claim 29 are critical. See Appeal Br. 23-25. For the reasons discussed
above with respect to Rejection 1, we are persuaded that Appellants have
carried their burden of rebutting the Examiner's prima facie case of
obviousness, and we reverse Rejection 2.
CONCLUSION
We reverse Rejections 1 and 2.
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Application 13/469,481
REVERSED
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