Ex Parte Mantelle et al

Patent Trial and Appeal Board

Jul 11, 2016

12981154 (P.T.A.B. Jul. 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 07113/2016
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
07/13/2016 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. FRED MAN, KIMBERLY McGRAW, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING 1
Appellants request rehearing of the decision entered April 13, 2016
("Decision") affirming the rejection of claims under 35 U.S.C. § 103(a) and
obviousness-type double patenting.
Appellants' request is granted and our affirmance of the Examiner's
rejection is hereby designated as a New Grounds of Rejection, but we
decline to modify the reasoning underlying our original Decision.
1 Appellants identify the Real Party in Interest as Noven
Pharmaceuticals, Inc. (see App. Br. 3).
Appeal2013-008738
Application 12/981, 154
DISCUSSION
Unpredictability
Appellants contend that "the Board still must consider Quan for what
it evidences regarding the state of the art and the high level of
unpredictability in the art" (Req. R'hrg 3). Appellants contend that
(Id.).
Quan evidences the high level of unpredictability in at least two
separate ways. First, Quan teaches that its enhancer is useful
for basic drugs having a pKa of about 8.0 or higher, but not for
the weakly basic drug piroxicam which has a pKa of 6.3 ...
Second, Quan teaches that while triacetin is an effective
enhancer for oxybutininpolymer compositions, it reports that it
was not an effective enhancer for oxybutinin gel compositions.
We agree that Quan must be addressed (see, e.g., Dec. 10, addressing
Appellants' arguments regarding Quan's asserted teaching away), but for the
reasons in the Decision, we find Appellants' arguments regarding the
teachings of Quan unpersuasive to rebut the obviousness case over Miranda
and Baker (Dec. 10-11 ). We note that:
[O]bviousness must be determined in light of all the facts, and
there is no rule that a single reference that teaches away will
mandate a finding of nonobviousness. Likewise, a given course
of action often has simultaneous advantages and disadvantages,
and this does not necessarily obviate motivation to combine.
See [Winner Int'! Royalty Corp. v. Wang, 202 F.3d 1340, 1349
n.8 (Fed. Cir. 2000)] ("The fact that the motivating benefit
comes at the expense of another benefit, however, should not
nullify its use as a basis to modify the disclosure of one
reference with the teachings of another. Instead, the benefits,
both lost and gained, should be weighed against one another.").
Where the prior art contains "apparently conflicting" teachings
(i.e., where some references teach the combination and others
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teach away from it) each reference must be considered "for its
power to suggest solutions to an artisan of ordinary skill ....
consider[ing] the degree to which one reference might
accurately discredit another." In re Young, 927 F.2d 588, 591
(Fed. Cir. 1991).
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006).
In this case, that Quan teaches the use of enhancers, whether useful at
one pKa or another, and with particular formulations or another, for
methylphenidate administration, represents a distraction that does not
address the underlying obviousness question of whether Miranda and Baker
render topical application of methylphenidate in a polymer that lacks an
enhancer obvious. As noted in the Decision, Miranda teaches and claims
transdermal drug delivery of methylphenidate (Dec. FF 4) with non-
functional acrylic polymer adhesives (Dec. FF 1) as well as overlapping
methylphenidate amounts (Dec. FF 2).
Most importantly, Miranda teaches that the composition comprises
"optionally, an enhancer" (Dec. FF 1 ). This teaching that the enhancer is
optional, though it may come at a cost of Quan's improved skin flux (see
Quan, col. 10, 11. 11-13), reasonably represents an obvious alternative to the
ordinary artisan.
While Quan may show some degree of unpredictability, Quan does
not demonstrate or rebut the teaching of claim 50 of Miranda, ultimately
dependent from claim 4, that drugs including methylphenidate may be
transdermally delivered in a polyacrylate system where the enhancer is
optional (Dec. FF 1-5).
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Antor explained that "[ e ]nablement of prior art requires that the
reference teach a skilled artisan to make or carry out what it discloses in
relation to the claimed invention." In re Antor Media Corp., 689 F.3d 1282,
1290 (Fed. Cir. 2012). Antor further teaches that the Appellants must show
"that undue experimentation would be required to perform the claimed
invention based on the teaching" in the prior art. Id. at 1289. Appellants
have made no showing that undue experimentation would have been
required to implement claim 50 of Miranda to a methylphenidate
transdermal drug delivery system without enhancer.
The instant facts are better than those in Antor or the cases cited in
Antor because the disclosure relied upon here in Miranda is to examined and
issued claims, which receive a statutory presumption of validity, and
consequently enablement, under 35 U.S.C. § 282.
Appellants next contend that
Baker's disclosure of a controlled release oral composition that
releases drug over a period of at least 8 hours does not teach or
suggest that methylphenidate could be formulated without an
enhancer in a pharmaceutical composition for topical
application that would be effective to deliver methylphenidate
in an amount and at a rate sufficient to increase
methylphenidate plasma concentration upon application to the
skin of a subject (as recited in claims 39 and 49), let alone that
such a composition would be effective to achieve delivery over
a period of at least 10 hours (as recited in claim 43).
(Req. R'hrg 4).
We remain unpersuaded by this argument for the reasons given in the
Decision that noted "Miranda teaches delivery time is an optimizable
variable, specifically teaching that the 'amount of drug to be incorporated in
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the composition varies depending on ... the time span for which the device
is to provide therapy' (FF 1)" (Dec. 12). With the knowledge that the time
span and concentrations are optimizable variables, and Baker's motivation to
deliver methylphenidate for periods of 8-16 hours (Dec. FF 7), the evidence
reasonably supports the conclusion that such delivery would have been
obvious. Appellants provide no evidence of unexpected results or another
secondary consideration to rebut this obviousness conclusion.
Appellants contend that "there is no teaching, suggestion or guidance
in Miranda that would have led a person of ordinary skill in the art to select
a non-functional acrylic polymer in particular when formulating
methylphenidate" (Req. R'hrg 5).
We find this argument flatly inconsistent with Miranda. Claim 50 of
Miranda, depending from claim 4, specifically requires incorporation of a
polyacrylate, a non-functional acrylic polymer, in a transdermal drug
delivery system for methylphenidate (Dec. FF 1--4 ). This is reasonably
understood as guidance for selection of the non-functional acrylic polymer
in formulating methylphenidate. Moreover, our obviousness conclusion is
consistent with Wrigley, where 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).
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Enhancers
Appellants contend that "even though the presence of an enhancer was
not required for patentability of Miranda's claims, a person of ordinary skill
in the art following Miranda would have been motivated to include an
enhancer since about 95% of Miranda's examples include an enhancer"
(Req. R'hrg 6).
We are not persuaded because Miranda specifically suggests that the
drug delivery device may comprise "optionally, an enhancer" (Dec. FF 1 ).
Miranda expressly recognizes that "[ o ]ptional additives, such as co-solvent
for the drug (up to 30% by weight) and enhancers (up to 20% by weight)
may be included in the dermal adhesive composition" (Miranda, col. 4, 11.
24--27). These are direct suggestions that the enhancer is optional, and need
not be included.
Appellants further contend that
a person of ordinary skill in the art would not have had any
reasonable expectation that methylphenidate could be
formulated without an enhancer with a non-functional acrylic
polymer to obtain a composition that is effective to deliver
methylphenidate in an amount and at a rate sufficient to
increase methylphenidate plasma concentration upon
application to the skin of a subject
(Req. R'hrg 6). Appellants contend that Miranda's "five non-enhanced
nitroglycerin examples would not have suggested or provided a reasonable
expectation of success with regard to the claimed compositions" as these
examples exhibit poorer drug flux as compared to the examples that contain
an enhancer. (Req. R'hrg 6-7). Appellants contend that "Quan's teachings
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as a whole discredit and discourage compositions formulated without
enhancer, since Quan used such compositions as comparative examples to
highlight the advantages of its compositions" (Req. R'hrg 7).
We find these arguments unpersuasive. As we already addressed in
the Decision, none of these references including Quan teach away from drug
delivery without the use of enhancers (see Dec. 10). Appellants provide no
evidence that the ordinary artisan would have found Miranda's express
suggestion that the enhancer may be optional is incorrect, nor does the
evidence in Figures 2 and 4 of Miranda rebut this conclusion. Indeed, the
ordinary artisan recognizes that "a given course of action often has
simultaneous advantages and disadvantages, and this does not necessarily
obviate motivation to combine." Medichem, 437 F.3d at 1165. Here,
optimization of polymer ratios, drug amounts, and other components allows
for different amounts of drug to be delivered, as desired by the ordinary
artisan. This balancing is expressly recognized by Miranda, who teaches,
regarding Figure 4, that the "composition of the blend of polymers is
preferably chosen so that the flux rate of drug from the blend is at a
maximum" as well as teaching that in "alternative embodiments, it may be
desirable to select a composition in which the flux rate will be retarded"
(Miranda, col. 40, 11. 1-7). Thus, the ordinary artisan would have
recognized that based on the desired flux rate, an optional enhancer may be
omitted from the drug delivery composition.
Genus/Species
Appellants contend that
neither claim 50 of Miranda, nor any other portion of Miranda,
provides any guidance that would have led a skilled artisan to
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prepare a methylphenidate composition that comprises 5 to
35 wt% methylphenidate and a non-functional acrylic polymer,
wherein the composition does not include an enhancer, as
recited in the instant claims.
(Req. R'hrg 10). Appellants contend that "[t]he fact that a claimed species
or subgenus is encompassed by a prior art genus is not sufficient by itself to
establish a primafacie case of obviousness. In re Baird, 16 F.3d 380, 382,
29 USPQ2d 1550, 1552 (Fed. Cir. 1994)" (Req. R'hrg 10). Appellants
contend that the "MPEP sets forth a number of factors ... which would not
support a finding of obviousness here, such as the size of genus (i.e., the
extensive laundry lists of drugs and polymers), the specific teachings of the
cited reference ... and the high level of unpredictability" (Req. R'hrg 11-
12). Appellants contend that "the Board's reliance on a per se rule of
obviousness is legal error" (Req. R'hrg 12).
We are not persuaded by these arguments because the Decision does
not rely upon a per se rule of obviousness, but rather on consideration of the
express teachings and claims of Miranda and Baker as would have been
understood by one of ordinary skill in the art.
In Baird, the Federal Circuit found that the generic formula
encompassed "more than 100 million different di phenols, only one of which
is bisphenol A [the compound at issue]." Baird, 16 F.3d at 382. In Baird,
there was no direction to the specific compound, much less any indication
that the specific compound at issue would function.
By contrast, the case at hand presents a very different situation where
Miranda specifically identifies and claims methylphenidate and specifically
identifies and claims acrylate polymers in overlapping amounts (Dec. FF 1-
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4). See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376 (Fed. Cir.
2005) ("This court rejects the notion that one of [ 14 listed] ingredients
cannot anticipate because it appears without special emphasis in a longer
list.").
In the instant case, the rejection is obviousness, not anticipation, so it
is only necessary that Miranda render obvious the use of methylphenidate in
a topical drug delivery system comprising an acrylic polymer and lacking an
enhancer (Dec. FF 1--4). In Gleave, the Federal Circuit expressly addressed
the issue of lists of large numbers of compounds in an anticipation context,
where the "list includes more than 1400 sequences." In re Gleave, 560 F.3d
1331, 1333 (Fed. Cir. 2009). The Court, found that "Wraight expressly lists
every possible fifteen-base-long oligodeoxynucleotide sequence in IGFBP-
2, and under our precedent, this list anticipates Gleave's claims." Id. at
1338. Here, the list of drug compounds is limited to three in claim 50,
which depends from claim 4' s teaching of a topical drug delivery
composition containing acrylic polymers and where an enhancer is disclosed
as optional (Dec. FF 1--4). We have already addressed Appellants'
contention regarding unpredictability above.
Therefore, Appellants' genus/species argument is not found
persuasive because the ordinary artisan would have had reason to select the
species claimed based on the teachings of Miranda and Baker.
Claim 43
Appellants contend that
the Board misapprehended that disclosure of Miranda. As
noted at page 13 of the Reply Brief, Figure 16 of Miranda
relates to compositions of a different drug ( estradiol)
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formulated with two enhancers ( oleic acid and dipropylene
glycol). The fact that Miranda was able to formulate a different
drug with a dual enhancer system and achieve drug delivery
over an extended period of time in no way suggests that a
composition comprising methylphenidate formulated without
an enhancer would be effective to achieve delivery over a
period of at least 10 hours!
(Req. R'hrg 13).
We remain unpersuaded by this attorney argument without any
evidentiary basis. Appellants provide no evidence that formulating
methylphenidate without enhancer would fail to achieve delivery over a 10
hour period, while Miranda expressly teaches that the "characteristic net
solubility parameter can be preselected to adjust the saturation concentration
of the drug in the composition and thereby control the release of the drug"
(Miranda, col. 4, 11. 30-33). Miranda teaches that "[t]hose skilled in the art
can readily determine the rate of delivery of drugs from the multiple
polymer adhesive system in order to select suitable combinations of
polymers and drug for a particular application" (Miranda, col. 9, 11. 25-28).
Finally, Miranda teaches 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"
(Miranda, col. 32, 11. 51-54) (Emphasis added).
Balancing the express teachings of Miranda that time span is a
routinely optimizable variable against attorney argument, we find
Appellants' arguments unpersuasive. Moreover, Appellants provide no
evidence that the time span was unexpected in any way. See In re Lindner,
457 F.2d 506, 508 (CCPA 1972) ("mere lawyers' arguments unsupported by
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factual evidence are insufficient to establish unexpected results"); In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (The inventor "did not offer
evidence of unexpected results in the form of a statement to that effect from
the inventors or any third party, or any objective evidence from a respected
source-the kind of evidence that we have previously required to rebut a
prima facie case.")
Claims 44 and 49
We recognize, but find unpersuasive, Appellants' contention that
"claim 4 of Miranda (from which claim 50, the only claim that recites
methylphenidate, depends) recites components (i), (ii) and (iii) that are
excluded by the 'consisting of' language of claims 44 and 49" (Req. R'hrg
14). Appellants provide no evidence or reason why the composition
composed of the particular elements of claims 44 and 49 would have been
unobvious over the broader teachings of Miranda that "[ t ]hose skilled in the
art can readily determine the rate of delivery of drugs from the multiple
polymer adhesive system in order to select suitable combinations of
polymers and drug for a particular application" (Miranda, col. 9, 11. 25-28).
Obviousness Double Patenting
We recognize, but find unpersuasive, Appellants' contention that "to
the extent the Board may rely upon the same misapprehensions of Miranda
as relied upon in the context of the obviousness rejection, Appellant urges
the Board to take into account the discussion of Miranda set forth above"
(Req. R'hrg 15). Given that the rejection relies substantially upon the claims
of Miranda and that our Decision expressly considered the double-patenting
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rejections along with the obviousness rejections (see Dec. 3), we remain
unpersuaded for the reasons already given above.
New Grounds and Reversal
Appellants contend that "the thrust of the Examiner's rejection to
which Appellant did respond was quite different from the thrust of the
Board's rejection" (Req. R'hrg 16).
Having considered Appellants' arguments, we agree that the Decision
relying upon Miranda and Baker, and our arguments in discussing that
Decision, may be viewed as changing the thrust of the rejection presented by
the Examiner. Therefore, we herein designate the currently presented
rejection -- that is, the rejection as presented by the Appeal Decision and
explained by the Decision on Reconsideration -- as constituting new grounds
of rejection under 37 C.F.R. § 41.50(c). However, we will not reverse the
Examiner's rejection that relied upon Quan, Miranda and Baker simply
because our reasoning differed and we relied solely upon Miranda and
Baker.
Because Appellants' request was timely, in the interest of fairness, we
are entering the new grounds of rejection per today's Decision and thus
setting the period for response as starting from the date hereof.
The new grounds of rejection shall not be considered final for judicial
review. 37 C.F.R. § 41.50(b). Appellants must, WITHIN TWO MONTHS
FROM THE DATE OF THIS DECISION, exercise one of the following two
options with respect to the new ground of rejection to avoid termination of
the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
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to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record ....
GRANTED; 37 C.F.R. § 41.50(b)
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