Ex Parte Mantelle et al

Patent Trial and Appeal Board

Apr 11, 2016

12981154 (P.T.A.B. Apr. 11, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/981,154 12/29/2010 Juan Mantelle
22428 7590 04/13/2016
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
041457-0928 6016
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
04/13/2016 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUAN MANTELLE and TERESE A. DIXON
Appeal2013-008738
Application 12/981, 154
Technology Center 1600
Before JEFFREY N. FREDMAN, KIMBERLY McGRAW, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition for topical application of methylphenidate. The
Examiner rejected the claims as obvious and for double patenting. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as N oven
Pharmaceuticals, Inc. (see App. Br. 3).
Appeal2013-008738
Application 12/981, 154
Statement of the Case
Background
A "controlled release tablet of methylphenidate ... which was
designed to eliminate the need for multiple administrations of a tablet during
the school day for children and reduce dosing to either once or twice a day,
falls short of providing effective treatment for a significant portion of the
patient's waking hours" (Spec. i-f 4).
The Claims
Claims 39--46, 48, and 49 are on appeal. Independent claim 39 is
representative and reads as follows:
1. A pharmaceutical composition for topical application
of methylphenidate, comprising a therapeutically effective
dose of methylphenidate in a polymer carrier of a flexible
finite, system, wherein the composition comprises 5 to 3 5
wt% methylphenidate based on the total weight of the
composition and a non-functional acrylic polymer, wherein
the composition does not include an enhancer, and wherein
the composition delivers methylphenidate in an amount and
at a rate sufficient to increase methylphenidate plasma
concentration upon application to the skin of a subject.
The Issues
A. The Examiner rejected claims 39--46, 48, and 49 under 35 U.S.C.
§ 103(a) as obvious over Quan,2 Miranda, 3 Baker,4 Jaeger, 5 and EPO-T6
(Non-Final Act. 7 3-16).
2 Quan et al., US 5,601,839, issued Feb. 11, 1997.
3 Miranda et al., US 5,656,286, issued Aug. 12, 1997.
4 Baker et al., US 5,874,090, issued Feb. 23, 1999.
5 Jaeger et al., US 5,273,757, issued Dec. 28, 1993.
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B. The Examiner rejected claims 39--43, 45, 46, 48, and 49 on the ground
of nonstatutory obviousness-type double patenting over claims 4, 13, 49, and
50 of Miranda in view of Baker (Non-Final Act. 19).
C. The Examiner rejected claims 39--46, 48, and 49 on the ground of
nonstatutory obviousness-type double patenting over claims 1-15 and 18-24
of US 6,210,705 (Non-Final Act. 17-18).
D. The Examiner rejected claims 39--46, 48, and 49 on the ground of
nonstatutory obviousness-type double patenting over claims 1-27 of US
6,348,211 (Non-Final Act. 18).
E. The Examiner rejected claims 39--46, 48, and 49 on the ground of
provisional nonstatutory obviousness-type double patenting over claims 1-
11, 13, and 39-55 of US 13/071,048 (Non-Final Act. 19-20).
A. and B. 35 U.S.C. § 103(a) over Quan, Miranda, Baker, Jaeger, and
EPO-T and Obviousness-type Double Patenting over Miranda and Baker
Because the obviousness and double patenting rejections both rely
upon the combination of Miranda and Baker, we will consider these
rejections together.
In affirming a multiple reference rejection under 35 U.S.C. § 103, the
Board may rely on fewer than all of the references relied on by the Examiner
6 EPO-T 0036/02, Solid matrix system for transdermal drug
delivery, http://www.epo.org/law-practice/case-law-
appeals/recent/t020036eul .html (2006).
7 All citations to the Non-Final Action refer to the Non-Final
action mailed October 05, 2012.
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in an obviousness rationale without designating it as a new ground of
rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1961).
As prior art, we will rely solely on claims 4, 13, 49, and 50 of
Miranda and those portions of Miranda expressly identified by the Examiner
in combination with Baker, a rejection to which Appellants have had fair
opportunity to respond. (See Non-Final Act. 19; App. Br. 19-20). See In re
Kronig, 539 F.2d 1300, 1302 (CCPA 1976) ("[T]he ultimate criterion of
whether a rejection is considered 'new' in a decision by the board is whether
appellants have had fair opportunity to react to the thrust of the rejection.")
The issue with respect to this rejection is: Does the evidence of record
support the Examiner's conclusion that Miranda and Baker render the claims
obvious?
Findings of Fact
FF 1. Claim 4 of Miranda is reproduced below:
4. A transdermal drug delivery system comprising
a pressure-sensitive adhesive composition, wherein said
composition comprises of a blend of
(a) a pressure-sensitive adhesive selected from the
group consisting of
(i) polyisoprene, polystyrene, polyethylene,
polybutadiene, polyethylene/butylene,
styrene/butadiene, styrene-butadiene-styrene,
styrene-isoprene-styrene, styrene-
ethylene/butylene-styrene block copolymers, butyl
rubber, polytetrafluoroethylene, polyvinyl
chloride, polyvinylidene chloride,
polychloroprene, polyacrylonitrile and
polychlorodiene, and mixtures thereof, in an
amount from about 14 % to about 94 % by weight
of the total pressure-sensitive adhesive
composition;
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(ii) polyisobutylene and mixtures thereof in an
amount from about 10% to about 90% by weight
of the total pressure-sensitive adhesive
composition; and
(iii) polysiloxane and mixtures thereof in an amount
from about 5% to about 95% by weight of the total
pressure-sensitive adhesive composition;
(b) a polyacrylate in an amount from about 5% to
about 85%, wherein said polyacrylate and said
pressure-sensitive adhesive (a) differ in solubility
parameter by an increment of at least 2 (J/cm3) 112 ;
( c) a soluble polyvinylpyrrolidone in an amount
from about 1 % to about 20% by weight of the total pressure-
sensitive adhesive composition;
( d) one drug or a mixture of two or more drugs;
and
( e) optionally, an enhancer in an amount up to
about 20% by weight of the total pressure-sensitive adhesive
composition.
(Miranda, col. 61, 11. 16-46; cf Miranda, col. 2, 11. 52-57, "The amount of
drug to be incorporated in the composition varies depending on the
particular drug, the desired therapeutic effect, and the time span for which
the device is to provide therapy").
FF 2. Claim 13 of Miranda is reproduced below:
13. The transdermal drug delivery system according to
claim 4, wherein said drug is present in said system from
about 0.1 % to about 50% by weight of the total pressure-
sensitive adhesive layer.
(Miranda, col. 62, 11. 4--7; cf Miranda, col. 32, 11. 51---63).
FF 3. Claim 49 of Miranda is reproduced below:
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Application 12/981, 154
49. The transdermal drug delivery system of claim 4.
wherein said drug has an action on the central nervous
system.
(Miranda, col. 64, 11. 7-9).
FF 4. Claim 50 of Miranda is reproduced below:
50. The transdermal drug delivery system of claim 49,
wherein the drug is nicotine, methylphenidate and tacrine.
(Miranda, col. 64, 11. 10-11; cf Miranda, col. 28, 1. 7).
FF 5. The Examiner finds that
monomers with 0% functional groups [were] contemplated
by Miranda especially in the case of alkyl acrylate
monomers thus reading on "non-functional acrylic polymer"
thus providing sufficient specificity to select non-functional
acrylic polymers in these types of systems. Indeed, Miranda
specifically directs the artisan to polymethylmethacrylate,
polyethylmethacrylate, polymethacrylate and
polyethylacrylate (column 8, Table LA .. ) \vhich \vould be
non-functional acrylates since there are no acid groups in
these esters.
(Non-Final Act. 7; cf Miranda, col. 10, 11. 54--57).
FF 6. Baker teaches that "[m]ethylphenidate is a known drug ... used
primarily to treat hyperactive children" (Baker, col. 1, 11. 9-10). Baker
teaches "nominal dose levels of racemate: 1.5, 3, 4.5 or 6 mg base/kg body
weight" (Baker, col. 3, 11. 2-3).
FF 7. Baker teaches that "a serum level of [ methylphenidine] can be
attained that is at least 50% of Cmax, over a period of at least 8 hours, e.g. 8-
16, 8-12 or 8-10 hours" (Baker, col. 2, 11. 28-31).
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Principles of Law
In Wrigley, the Federal Circuit found a "strong case of obviousness
based on the prior art references of record. [The claim] recites a combination
of elements that were all known in the prior art, and all that was required to
obtain that combination was to substitute one well-known ... agent for
another." Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356,
1364 (Fed. Cir. 2012).
Analysis
Claim 39
Miranda teaches a transdermal drug delivery composition (FF 1 ).
Miranda teaches incorporation of non-functional acrylic polymer adhesives
(FF 1, 5). Miranda teaches that the transdermal drug delivery composition
may deliver methylphenidate (FF 4). Miranda teaches amounts of drug that
overlap with the claimed 5 to 35 wt% range (FF 2). Miranda teaches that the
use of an enhancer is optional, and therefore the composition need not
include an enhancer (FF 1 ).
Baker teaches reasons to use methylphenidate and teaches that the
doses may be optimized based on parameters including body weight (FF 6)
and teaches optimization of delivery times (FF 7).
The Examiner finds that "the delivery period is intrinsic to the
composition since the same materials are used and the disclosure of
methylphenidate includes all forms of methylphenidate including those
taught by Baker" (Non-Final Act. 19).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the ordinary artisan would have found obvious a transdermal
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patch composition comprising methylphenidate and non-functional acrylic
polymer over Miranda and Baker without a requirement for an enhancer (FF
1---6). Such a combination is merely a "predictable use of prior art elements
according to their established functions." KSR, 550 U.S. 398, 417 (2007).
We agree with the Examiner that the transdermal patch would have
predictably been expected to increase methylphenidate plasma concentration
when applied to the skin because that represents the entire point of
transdermal patch drug delivery (Non-Final Act. 19; FF 1).
We note that Appellants provide no evidence of any secondary
consideration, such as unexpected results, that need be weighed with the
Examiner's prima facie case of obviousness.
Appellants contend that "Miranda provides no guidance to use a non-
functional acrylic polymer in particular when formulating methylphenidate"
(App. Br. 12).
We do not find this argument persuasive because Miranda specifically
teaches acrylic polymers (FF 1) and Appellants do not rebut the Examiner's
finding that Miranda teaches the incorporation of non-functional acrylic
polymers as components of the transdermal patch (FF 5).
Appellants contend
The Examiner cited claim 50 of Miranda, which recites
methylphenidate and two other drugs, but neither that claim
nor any other portion of Miranda provides any guidance that
would have led a skilled artisan to prepare a
methylphenidate composition that comprises a non-
functional acrylic polymer and no enhancer, as recited in the
instant claims.
(App. Br. 12).
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We do not find this argument persuasive. That the prior art "discloses
a multitude of effective combinations does not render any particular
formulation less obvious. This is especially true because the claimed
composition is used for the identical purpose taught by the prior art." Merck
& Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Moreover,
"picking and choosing may be entirely proper in the making of a 103,
obviousness rejection." In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972).
In particular, a transdermal patch composition comprising
methylphenidate and a non-functional acrylic polymer with the enhancer
optional recites a combination of elements that were all suggested by
Miranda and Baker, and all that was required to obtain that composition was
to select or substitute well-known agents expressly disclosed and claimed by
Miranda and Baker (FF 1---6).
Appellants contend that "the skilled artisan would have seen that
Quan' s specific range overlaps with Miranda's general range, and so would
have found no reason to modify that aspect of Quan" (App. Br. 12).
We do not find this argument persuasive because Miranda and Baker
expressly recognize that the drug dosage amount is optimizable. In
particular, Miranda explains that the "amount of drug to be incorporated in
the composition varies depending on the particular drug, the desired
therapeutic effect, and the time span for which the device is to provide
therapy" (FF 1 ). Moreover, Baker teaches varying dose levels of
methylphenidate, in part dependent upon body weight (FF 6). "[W]here the
general conditions of a claim are disclosed in the prior art, it is not inventive
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to discover the optimum or workable ranges by routine experimentation." In
re Aller, 220 F .2d 454, 456 (CCP A 1955).
We recognize, but find unpersuasive, Appellants' contention that
"[b ]y teaching compositions that comprise a penetration enhancer, and by
using compositions without a penetration enhancers as comparative
examples, Quan teaches away from the claimed compositions, which do not
include an enhancer" (App. Br. 15).
Miranda expressly teaches that the penetration enhancers are optional
(FF 1 ). Appellants do not identify a teaching in Quan that specifically
discredits or discourages transdermal patches lacking a penetration enhancer,
instead citing Quan's teaching that penetration enhancers enhance the flux of
drugs across the skin (see Quan, col. 1, 11. 57----62; App. Br. 15). Appellants
do not cite any specific teaching in Quan that methylphenidate will not be
delivered by a transdermal patch without penetration enhancers.
We recognize, but find unpersuasive, Appellants' contention that
the skilled artisan would not have understood Miranda's
general statements or claim language to provide a reasonable
expectation that a composition as claimed, comprising 5 to
35 wt% methylphenidate, a non-functional acrylic polymer,
and no enhancer, would deliver methylphenidate in an
amount and at a rate sufficient to increase methylphenidate
plasma concentration upon application to the skin of a
subject.
(App. Br. 17).
Kubin stated that, "[r]esponding to concerns about uncertainty in the
prior art influencing the purported success of the claimed combination, this
court [in 0 'Farrell] stated: ' [ o ]bviousness does not require absolute
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Application 12/981, 154
predictability of success ... all that is required is a reasonable expectation
of success."' In re Kubin, 561F.3d1351, 1360 (Fed. Cir. 2009) (citing In re
O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)).
Here, Miranda's express suggestion of transdermal patches which
may comprise methylphenidate, non-functional acrylic polymers without
penetration enhancers (FF 1-5) provides a reasonable expectation of success
in the absence of rebuttal evidence. This is consistent with Antor, which
held "that a prior art printed publication cited by an examiner is
presumptively enabling barring any showing to the contrary by a patent
applicant." In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012).
In this case, where Miranda not only discloses the elements of the claim but
actually recites these elements in claims 4, 13, 49, and 50, the burden is
reasonably shifted to Appellants to demonstrate with evidence, not attorney
argument, that Miranda lacked a reasonable expectation of success (FF 1-5).
Claim 43
Appellants contend that the rejection lacks any "evidence whatsoever
that any composition of Quan achieves drug delivery over a period of at least
10 hours, let alone that a modified composition of Quan, lacking Quan' s
enhancer, would achieve such results. Further, as discussed above, none of
the secondary references disclose any specific methylphenidate
formulations" (App. Br. 18).
The Examiner responds that "such a functional limitation is intrinsic
to the components of the composition ... and Miranda also teaches that such
a time frame should be expected as shown in Figure 16" (Ans. 9-10). The
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Examiner finds that the "the flux of drug is over 10 hrs through human skin"
(Ans. 10).
We find that the Examiner has the better position. Miranda teaches
delivery time is an optimizable variable, specifically teaching that the
"amount of drug to be incorporated in the composition varies depending on
... the time span for which the device is to provide therapy" (FF 1 ).
Moreover, Figure 16 relied upon by the Examiner, reproduced below,
demonstrates release of drug from a transdermal delivery device over time
periods exceeding 10 hours.
FIG. 16
f] EXAMPLE ~4
"FIG. 16 shows the average flux of estradiol for two compositions of this
invention containing a soluble PVP" (Miranda, col. 6, 11. 11-12). Thus, the
ordinary artisan would have found the release time a results optimizable
variable and Baker motivates release rates of methylphenidate over periods
of 8 to 16 hours (FF 7).
Claims 44 and 49
Appellants contend that there "is no teaching or suggestion in any of
the cited references of a pharmaceutical composition for topical application
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of a therapeutically effective dose of methylphenidate with a polymer matrix
that consists of methylphenidate and a non-functional acrylic polymer"
(App. Br. 19).
We find this argument unpersuasive for the reasons already given.
Miranda reasonably suggests transdermal patches composed of
methylphenidate and non-functional acrylic polymers and lacking
penetration enhancers (FF 1-5). Appellants provide no specific reason or
evidence explaining why Miranda does not obviate "consisting of' claims.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Miranda and Baker render the claims obvious.
C.-E. Double Patenting
Appellants do not provide any arguments relating to the double
patenting rejections. We summarily affirm the obviousness-type double
patenting rejections. See Manual of Patent Examining Procedure§ 1205.02
("If a ground of rejection stated by the examiner is not addressed in the
appellant's brief, that ground of rejection will be summarily sustained by the
Board.")
SUMMARY
In summary, we affirm all of the rejections.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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