Ex Parte Kobayashi et al

Patent Trial and Appeal Board

Oct 5, 2016

13693987 (P.T.A.B. Oct. 5, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/693,987 12/04/2012
20995 7590 10/07/2016
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
FIRST NAMED INVENTOR
Hirokazu Kobayashi
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.
TOYA173.002Dl 8698
EXAMINER
PAGONAKIS, ANNA
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
10/07/2016 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HIROKAZU KOBAYASHI, AKIRA NOZA WA, and
KATSUMASA ARIYOSHI
Appeal2015-003436
Application 13/693,987 1
Technology Center 1600
Before ELIZABETH A. LA VIER, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant seeks reversal of the
Examiner's rejection of claims 1-5 and 12-20. We have jurisdiction under
35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification describes luliconazole as an optically-active, wide-
spectrum anti-fungal agent. Spec. i-f 2. However, depending on the solvent
used and other conditions, luliconazole may be subject to a decrease in
1 Appellants state the real parties in interest are Nihon Nohyaku Co., Ltd.
and Pola Pharma Inc. Appeal Br. 2.
Appeal2015-003436
Application 13/693,987
optical purity when stored in its dissolved state. Id. To suppress this
decrease in optical purity, the Specification describes compositions
comprising luliconazole and crotamiton and/or another organic solvent. Id.
at i-f 10.
Claim 1 is representative:
1. A pharmaceutical composition for external use, comprising:
i) (R)-luliconazole represented by the following structural
formula ( 1) and/ or a salt thereof; and
ii) crotamiton at a concentration of 0.1 to 40% by mass
(-)-(E)-[( 4R)-(2,4-dichlorophenyl)-1,3-dithiolan-2-iliden ]-1-
imidazolyl acetonitrile
Structural formula ( 1 ).
Corrected Claims Appendix 2.
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Application 13/693,987
REJECTION MAINTAINED ON APPEAL
Claims 1-5 and 12-20 stand rejected under 35 U.S.C. § 103, as
unpatentable over Sawamura2 and Uchida. 3 Ans. 2.
DISCUSSION
The Examiner relies on Sawamura as teaching antifungal
compositions comprising any of several antifungal compounds, including
lanoconazole (preferably at 0.3-3% by total weight), and crotamiton as a
preferred adhesion agent (preferably at 1.5-15%). Final Action 3--4 (citing
Sawamura claims 4, 6, and i-fi-f 11, 14).4 As is relevant to certain dependent
claims, Sawamura also teaches ethanol is an especially preferred solvent. Id.
at 4 (citing Sawamura i125).
However, Sawamura does not teach luliconazole. Thus the Examiner
turns to Uchida, which discloses that luliconazole is structurally related to its
predecessor, lanoconazole, and that the two compounds have "almost
identical" antifungal potency. Id. at 4 (citing Uchida 216). The Examiner
notes that luliconazole is an R-enantiomer, whereas lanoconazole is a
racemic compound consisting of active R- and S-enantiomers. Id.
2 Sawamura, JP 2005-289879, published Oct. 20, 2005, English (machine)
translation as cited by the Examiner on page 2 of the Answer.
3 Uchida et al., In vitro antifungal activity of luliconazole (NND-502), a
novel imidazole antifungal agent, J. INFECT. CHEMOTHER., 10:216-19
(2004).
4 Although paragraph 14 of Sawamura discusses the proportion of adhesion-
promoting agent, paragraph 13 provides that crotamiton "is excellent in
adhesion."
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Application 13/693,987
The Examiner finds it would have been obvious for one of ordinary
skill in the art "to substitute any of the anti-fungal agent[s]" of Sawamura
(such as lanoconazole) with luliconazole as disclosed in Uchida, as
luliconazole and lanoconazole are structurally similar and functionally
equivalent. See id. at 4. Further, according to the Examiner, there would
have been "at least a reasonable expectation of success that such a
substitution would provide similar products useful for the same purpose
which is treating fungal diseases." Id.
Appellants begin their argument by noting the differences between
luliconazole and lanoconazole. Structurally, luliconazole has two chlorine
groups on the benzene ring, while lanoconazole has only one. Appeal Br. 6.
Luliconazole is optically active, but lanoconazole is not. Id.; see also Reply
Br. 2. Given that neither Sawamura nor Uchida recognizes "that
luliconazole must be in the R form for activity and that conversion to
inactive SE form occurs upon storage,"5 Appellants argue that "[i]t could not
have been predicted ... that (R)-luliconazole could have been prevented
from increasing the amount of SE isomer by including crotamiton in the
formulation." Appeal Br. 7. Appellants further contend that there would
have been no reasonable expectation of success in solving that problem
5 Appellants also surmise that "the luliconazole of Uchida is a racemic
mixture" based on the fact that "Uchida does not acknowledge the problem
that (R)-luliconazole is easily isomerized, resulting in lowered optical
purity." Appeal Br. 6. However, we agree with the Examiner that Uchida
states that luliconazole is an (R)-enantiomer. Ans. 6 (discussing Uchida
216, as quoted at Ans. 5). In the face ofUchida's factual statement
concerning what luliconazole is, attorney argument that Uchida is a racemic
mixture is not competent evidence to the contrary. See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974).
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Application 13/693,987
because "Sawanmra includes crotamiton in combination with lanoconazole
as an adhesion adjuvant and not to preserve optical purity as optical purity is
not a problem for lanoconazole." Id. (citing Sawamura i-f 13, claim 5).
Appellants then discuss the alleged unexpected properties and results of the
claimed invention as demonstrated in the Specification and further in a
previously-submitted declaration pursuant to 37 C.F.R. § 1.132,
demonstrating the effect of crotamiton in suppressing the decrease in optical
purity for (R)-luliconazole under varied parameters meant to simulate or
exceed the severity of storage conditions. See id. at 7-9.
Appellants' arguments are unpersuasive. "In determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls. What matters is the
objective reach of the claim. If the claim extends to what is obvious, it is
invalid under§ 103." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 419
(2007). Instead, "any need or problem known in the field of endeavor at the
time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed." Id. at 420; see also In re
Lintner, 458 F.2d 1013, 1016 (CCPA 1972) ("The fact that appellant uses
sugar for a different purpose does not alter the conclusion that its use in a
prior art composition would be prima facie obvious from the purpose
disclosed in the references."). As the Examiner points out, Sawamura
teaches adding crotamiton in antifungal compositions "to aid in effective
topical application." Ans. 8. Indeed, Sawamura states that "crotamiton is
excellent in adhesion to the powder component affected skin [sic], and to
retain the dispersibility of the powder component, and furthermore is
excellent in terms of miscibility with the base component, with a suitable
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Application 13/693,987
deposition aid is there." Sawanmra if 5. Thus Sawanmra provides a
sufficient motivation for combining crotamiton with an antifungal agent. As
Uchida describes the structural similarity and functional equivalency of
luliconizole with lanoconazole (one of Sawamura' s antifungals ), we agree
with the Examiner (see Final Action 4--5; Ans. 6-8) that one of ordinary
skill in the art would have been motivated to combine Sawamura and Uchida
as claimed, independent of the storage stability issue identified by
Appellants.
We have also considered Appellants' evidence of unexpected
properties and success. But we remain unpersuaded, because we agree with
the Examiner that Appellants' "demonstration of properties is not evidence
of unexpected results but merely recognition of an undiscovered property."
Ans. 8. This is not sufficient to overcome a prima facie case of obviousness.
See In re Prindle, 297 F.2d 251, 254 (CCPA 1962) ("Mere recognition of
those latent properties does not render the otherwise obvious [claimed
subject matter] unobvious and thereby patentable.").
Accordingly, we affirm the Examiner's rejection of claim 1 as
obvious over Sawamura and Uchida. Claims 2-5 and 12-20, which are not
argued separately, fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
CONCLUSION
The rejection of claims 7-9 and 11 under 35 U.S.C. § 103(a) is
affirmed for the reasons of record and as explained herein.
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).
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AFFIRMED
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