Ex Parte Tani et al

Patent Trial and Appeal Board

Mar 27, 2018

12747644 (P.T.A.B. Mar. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121747,644 09/20/2010
23911 7590 03/29/2018
CROWELL & MORING LLP
INTELLECTUAL PROPERTY GROUP
P.O. BOX 14300
WASHINGTON, DC 20044-4300
FIRST NAMED INVENTOR
Kazuha Tani
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.
037209.62565US 7805
EXAMINER
BERRIOS, JENNIFER A
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
03/29/2018 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):
edocket@crowell.com
tche@crowell.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte Kazuha Tani and Mitsuji Akazawa 1
Appeal2017-002935
Application 12/7 4 7, 644
Technology Center 1600
Before DEMETRA J. MILLS, DEBORAH KATZ, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to an aqueous patch. The Examiner's rejection of claims 1
and 4 under 35 U.S.C. § 103 is appealed. We have jurisdiction under 35
U.S.C. § 6(b ).
We reverse.
1 Appellants identify the Real Party in Interest as "Teikoku Seiyaku Co.,
Ltd." Appeal Br. 1. Also, Appellants inform the Board in the submitted
Declaration Under37 C.F.R. § 1.132, signed Mar. 15, 2015, byKazuha
Takano (Takano Deel.), that the respective inventor's surname has changed
from "Tani" to "Takano."
Appeal2017-002935
Application 12/747,644
STATEMENT OF THE CASE
Independent claim 1, reproduced below, is representative:
1. An aqueous patch comprising an adhesive aqueous gel base
comprising a nonsteroidal anti-inflammatory analgesic (NSAID)
and a single solvent, wherein the NSAID consists of loxoprofen
or a salt thereof in an amount of 0.1 to 5% by weight based on a
weight of an adhesive gel base and the solvent consists of
triacetin in an amount of 0.5 to 5% by weight based on a weight
of an adhesive gel base, wherein the triacetin acts as a solvent to
dissolve the loxoprofen or a salt thereof.
Appeal Br. 14 (Claims App'x).
The following rejection is appealed:
Claims 1 and 4 stand rejected under 35 U.S.C. § 103(a) over
Okuyama, 2 Nakagawa, 3 and Y amakasi. 4 Final Action 3.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). And, while
"[ o ]bviousness does not require absolute predictability of success ... [it
does require] a reasonable expectation of success." In re 0 'Farrell, 853
F.2d 894, 903---04 (Fed. Cir. 1988).
2 US 5,496,819 (issued Mar. 5, 1996) ("Okuyama").
3 US 5,478,567 (issued Dec. 26, 1995) ("Nakagawa").
4 US 7,018,647 Bl (issued Mar. 28, 2006) ("Yamasaki").
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Application 12/747,644
The claims require an aqueous patch where triacetin acts as a solvent
to dissolve loxoprofen. The Examiner cited Okuyama, which discloses the
claimed formulation but-for inclusion of loxoprofen, instead disclosing
piroxicam, in a therapeutic plaster, combined with Nakagawa, which
discloses loxoprofen to be an NAISD drug (along with several other
examples, not including piroxicam), useful in a therapeutic plaster, and also
combined with Yamasaki, which discloses piroxicam as an NAISD drug
(along with other examples, not including loxoprofen) in a skin patch
product. Final Action 3--4. While the Examiner identified that Okuyama
did not include loxoprofen, the Examiner determined that:
one inventive in the art would have recognized piroxicam and
loxoprofen to be functionally equivalent active agents as the
prior art teaches them to both [to] be antiphlogistic analgesic
agents suitable for creating plasters, thus it would have been
obvious to substitute piroxicam for loxoprofen (selected from a
finite number of option in Nakagawa) in the plaster of Okuyama.
Id. at 4. The functional equivalency upon which the Examiner relied was
functioning as an active component in a skin patch. Id. at 5. The Examiner
concluded that, "[a ]lthough the art is silent to the solubility of loxoprofen in
triacetin, it is noted that a compound and its properties are inseparable, thus
the triacetin would inherently dissolve the loxoprofen." Id.
Appellants argue that the Examiner's determination of functional
equivalency of loxoprofen and piroxicam, without taking into consideration
compatibility with solvents, is error and, further, that because of the different
solubility characteristics of loxoprofen and piroxicam, the skilled artisan
would not have had a reasonable expectation of success in replacing
Okuyama's piroxicam with Nakagawa's loxoprofen. Appeal. Br. 4--7. In
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Application 12/747,644
support of this argument, Appellants cite to the Takano Declaration, which
in tum cites and quotes the Japanese Pharmacopoeia (submitted in relevant
portion), which states, regarding loxoprofen and piroxicam:
Description Loxoprofen Sodium Hydrate occurs as white to
yellowish white crystals or crystalline powder.
It is very soluble in water and in methanol, freely soluble
in ethanol (95), and practically insoluble in diethyl ether.
Description Piroxicam occurs as a white to pale yellow
crystalline powder.
It is sparingly soluble in acetic anhydride, slightly soluble
in acetonitrile, in methanol and in ethanol (99 .5), very slightly
soluble in acetic acid (100), and practically insoluble in water.
Takano Deel. 3--4 (quoting JAPANESE PHARMACOPOEIA XVI 1047, 1261
(2011)). Ms. Takano further states in her Declaration, "[t]herefore, based on
the differences between loxoprofen and piroxicam, one of ordinary skill in
the art would not have been motivated to apply the patch containing
piroxicam [as in Okyuyama] to prepare the patch containing loxoprofen [as
taught by Nakagawa]." Id. at 4.
We are persuaded by this argument and evidence. The claims require
that "the triacetin acts as a solvent to dissolve the loxoprofen." See supra
STATEMENT OF THE CASE (reproducing claim 1 ). Appellants' evidence
supports the fact that the solubility characteristics of piroxicam cannot
necessarily be attributed to loxoprofen. There is no evidence of record that
contradicts Appellants' position.
Based upon the prior art cited by the Examiner, what we can ascertain
regarding the solubilities of the various disclosed NAISD compounds that
can be used in skin patches or pastes is illustrated by the following diagram:
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Appeal2017-002935
Application 12/747,644
NA!SDs soluble
in triacetin
The illustration above is a Venn diagram showing that piroxicam is known
to be compatible with triacetin, and also (along with several other NAISDs)
N-methyl-2-pyrolidone, crotamiton, N,N-dimethyl acetamide, benzyl
alcohol, mint oil, and isopropuyl myristate; and that loxoprofen (along with
ketoprofen, ketorolac, and flurbiprofen) is soluble in resin ester derivative
with I-menthol. See Okuyamam 2: 14--19; Nakagawa 2: 1-7; Yamasaki
2:55---60, 4:49-56, 5:7-9. No relevant overlap is suggested between
piroxicam and loxoprofen. We conclude this is not enough, in view of
Appellants' evidence, to have motivated the skilled artisan to, or instilled a
reasonable expectation of success in replacing piroxicam with loxoprofen in
the formulation of Okuyama.
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Application 12/747,644
We note also that Appellants have argued unexpected results
concerning the stability of the claimed formulation as compared to
formulations not including triacetin as a solvent and formulations including
the solvent crotamiton. Appeal Br. 8. Because we conclude, based on the
evidence before us, that there would not have been a reason for the skilled
artisan to make the substitution relied upon by the Examiner and the
Examiner did not establish by a preponderance of the evidence that there
would have been a reasonable expectation of success, we do not determine if
the results identified by Appellants would have been unexpected as alleged.
For the reasons set forth above, we are persuaded that the claimed
aqueous patch would not have been obvious to one of ordinary skill in the
art. Therefore, we reverse the rejection.
SUMMARY
The obviousness rejection is reversed.
REVERSED
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