Noven Pharmaceuticals, Inc.

Patent Trials and Appeals Board

Oct 19, 2021

2021002274 (P.T.A.B. Oct. 19, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/206,369 03/12/2014 Robert Lambert 041457-1057 2053
22428 7590 10/19/2021
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
COUGHLIN, DANIEL F
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
10/19/2021 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 ROBERT LAMBERT, WEIJUN LU,
and JUN LIAO1
________________

Appeal 2021-002274
Application 14/206,369
Technology Center 1600
________________

Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
DAVID COTTA, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the term “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies Noven Pharmaceuticals, Inc. as the
real party-in-interest. App. Br. 2. Oral argument in this appeal was heard
on September 27, 2021, and a transcript of the hearing (“Trans.”) will be
made part of the record.
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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1, 4–6, 8, 10–12, 14, 16, and 20 under
35 U.S.C. § 103(a) as being obvious over the combination of Paul et al. (US
2006/0173124 A1, August 3, 2006) (“Paul”) and Kanios et al. (US
2005/0169977 A1, August 4, 2005) (“Kanios”).
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to transdermal drug delivery
compositions comprising amphetamine, methods of making them and
therapeutic methods using them. Spec. Abstr.

REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal and
recites:
1. A composition for the transdermal delivery of
amphetamine through skin in the form of a flexible finite system
for topical application to skin, comprising a backing layer and a
polymer matrix comprising amphetamine free base, wherein the
polymer matrix comprises from about 20% to about 80% by
weight of an acrylic block copolymer comprising two or more
blocks made from monomers including an acrylic monomer,
wherein the acrylic block copolymer comprises a block selected
from the group consisting of a poly(butyl acrylate) block, a
poly(methyl methacrylate) block, and a poly(butyl acrylate)
block,

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wherein the composition is capable of transdermally
delivering amphetamine through skin over a period of time of
from about 6 to about 12 hours.

App. Br. 23.

ISSUE AND ANALYSIS
We decline to agree with, or adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are obvious over the combined
teachings and suggestions of the cited prior art. We address below the
arguments raised by Appellant.

Issue 1
Appellant argues that the Examiner erred because the cited references
do not provide a reasonable expectation that the asserted combination of
polymer and amphetamine would be successful in achieving a composition
capable of delivering amphetamine over a period of time of from about 6 to
about 12 hours, as recited in claim 1. App. Br.14.

The Examiner’s findings and conclusion
The Examiner finds, in relevant part, that claim 1 recites a limitation
directed to the capability of the claimed composition to deliver amphetamine
over the time period of 6 to 12 hours. Final Act. 8. The Examiner finds that
although this recitation constitutes a functional limitation, the invention as
claimed is not structurally or compositionally distinguishable from the
combined teachings of the cited references. Id. It is the Examiner’s position
that the ability of the formulation to deliver amphetamine over a specified
period of time is an inherent property of the invention taught by the
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references. Id. at 8–9. The Examiner reasons that, because the Office does
not have the facilities for examining and comparing the claimed formulation
with the formulation of Paul and Kanios, the burden of proof falls upon
Appellant to demonstrate a non-obvious distinction between the structural
and functional characteristics of the claimed formulation and the formulation
of the prior art. Id. at 9. (citing, e.g., In re Best, 562 F.2d 1252, 1254–55
(C.C.P.A. 1997).
The Examiner further finds that Kanios expressly teaches that its
compositions deliver the active ingredient transdermally for a period of up 9
hours, which overlaps the claimed range of 6–12 hours. Final Act. 9.

Analysis
Appellant points to our reviewing court’s decision in In re Stepan Co.,
868 F.3d 1342 (Fed. Cir. 2021), which emphasized that functional claim
language limits a claimed combination of components to those combinations
that achieve the functional property, and must be considered in an
obviousness analysis. App. Br. 14 (citing Stepan Co., 868 F.3d at 1348).
Appellant contends that the Examiner invokes inherency as teaching this
limitation, finding that “the invention as claimed is not structurally or
compositionally distinguishable from the combined teachings of the cited
references,” such that the recited drug delivery period “is an inherent
property of the invention taught by the references.” Id. (quoting Final Act.
8–9).
Appellant argues that the Examiner’s reasoning is factual and legal
error for the same reasons as the rejections at issue in Stepan and in
Honeywell International Inc. v. Mexichem Amanco Holding S.A., 865 F.3d
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1348 (Fed. Cir. 2017). App. Br. 14–15. According to Appellant, the
assertion that the claimed compositions are “not ... distinguishable” from the
prior art ignores the functional claim language regarding the duration of drug
delivery, contrary to the guidance in Stepan. Id. at 15. Legally, argues
Appellant, the Examiner’s finding that the recited duration of drug delivery
is inherent ignores the warning in Honeywell that “the use of inherency in
the context of obviousness must be carefully circumscribed because ‘that
which may be inherent is not necessarily known’ and that which is unknown
cannot be obvious.” Id. (quoting Honeywell, 865 F.3d at 1354 (quoting In re
Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993))). Appellant points to the
Federal Circuit’s explanation that “[w]hat is important regarding properties
that may be inherent, but unknown, is whether they are unexpected. All
properties of a composition are inherent in that composition, but unexpected
properties may cause what may appear to be an obvious composition to be
nonobvious.” Id. (quoting Honeywell, 865 F.3d at 1355). Appellant argues
that the Examiner’s rejection constitutes legal error because it fails to take
into account the absence of any teaching or suggestion in Paul (or in the
combination of Paul and Kanios) that if its acrylic block copolymers were
used to prepare a transdermal amphetamine composition, the composition
would be capable of delivering amphetamine over an interval of time of
about 6 to about 12 hours. Id.
Appellant contends further that the Examiner has improperly placed
the burden of proof upon Appellant, arguing that Appellant “is not required
to compare the claimed invention with subject matter that does not exist in
the prior art.” App. Br. 15 (quoting MPEP § 716.02(e)). Appellant notes
that the Examiner finds that that Kanios “expressly teaches that the disclosed
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compositions deliver the active agent transdermally for ... up to 9 hours.” Id.
(quoting Final Act. 9 (citing Kanios Exs. 1–3, Figs. 3–5)). However, asserts
Appellant, the drug delivery profile achieved by Examples 1–3 of Kanios are
examples of multilayer systems formulated with random acrylic polymers,
and not in systems prepared with acrylic block copolymers, as taught by
Paul and recited in the claims. Id. Appellant asserts that there is no
evidence of record that the latter would exhibit a similar drug delivery
profile, or that would demonstrate that such a drug delivery profile would be
inherent to an amphetamine transdermal delivery system prepared with
Paul’s acrylic block copolymers. Id.
The Examiner responds that Paul expressly teaches a transdermal
device comprising the disclosed acrylic block copolymers that is designed to
remain on the skin of a patient for about 24 hours. Ans. 7 (citing Paul ¶ 57).
The Examiner also points out that Kanios teaches that acrylic polymers with
varying monomers were used in transdermal devices to assess the effect of
monomer composition on release of amphetamine from these devices over a
period of nine hours. Id. (citing Kanios ¶ 133). Specifically, the Examiner
points to Figure 3 of Kanios, which illustrates the rate of drug release from
these devices through nine hours. Id. The Examiner concludes that a person
of ordinary skill in the art would have had a reasonable expectation that
amphetamine formulated into a device comprising the polymer matrix of
Paul would produce extended drug release for a period greater than 6 hours,
as claimed. Id. at 7–8.
The Examiner further finds that Appellant’s Specification discloses
performance characteristics, such as drug release (rate and duration) of the
claimed transdermal devices, arise directly from the block copolymer of the
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adhesive matrix, including the drug release over a period of 6 to 12 hours.
Ans. 8 (citing Spec. 2).
The Examiner reiterates that the limitation in question constitutes a
functional limitation; however, the invention as claimed is not structurally or
compositionally distinguishable from the combined teachings of the cited
references. Ans. 8. Therefore, the Examiner reasons, the capability of the
formulation to deliver an active agent, such as amphetamine, over a
specified period of time is an inherent property of the invention taught by the
references. Id. (citing In re Wiseman, 596 F.2d 1019, 1023 (C.C.P.A. 1979);
MPEP § 2145(II)).
We conclude that Appellant has the better position. Paul is silent with
respect to the temporal release properties of an active agent from its acrylic
block copolymer compositions. Paul teaches:
Depending on the design of the patch and the condition to be
treated, the patch will remain on the skin for up to an hour or
more, up to about one week. In a preferred embodiment, the
patch is designed to remain on the skin at the application site for
about 24 hours, and to be changed daily.

Paul ¶ 57. Paul thus teaches that its patch can remain in place upon the skin
surface from an hour to a week, but it does not speak to the rate at which an
active agent will be released from the acrylic block copolymer, or to the
duration of that release.
Kanios teaches:
Determination of drug flux of the described formulations was
conducted on a modified Franz Diffusion cell through a disc of
stratum corneum obtained from human cadaver skin.… Samples
(n=5) of the solution were taken at various time points over the
study duration (9 hours), and drug concentrations were
determined by high pressure liquid chromatography.
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Kanios ¶ 133. Figures 3–5 of Kanios illustrate release of the drug under
different conditions and concentrations over the course of 9 hours. Id. at ¶¶
134–136. However, the compositions of Kanios are not the acrylic block
copolymers taught by Paul. Rather, Kanios teaches that:
In the practice of the preferred embodiments of the invention, the
acrylic-based polymer can be any of the homopolymers,
copolymers, terpolymers, and the like of various acrylic acids.
In such preferred embodiments, the acrylic-based polymer
constitutes from about 2% to about 95% of the total dry weight
of the of the carrier composition, and preferably from about 2%
to about 90%, and more preferably from about 2% to about 85%,
wherein the amount of the acrylic-based polymer is dependent
on the amount and type of drug used.

Kanios ¶ 52. Kanios thus does not teach acrylic block copolymers, but is
instead relied upon by the Examiner as suggesting that low molecular weight
neuroactive agents (amphetamine and methylphenidate) may be
interchangeably employed in the acrylic block copolymer system taught by
Paul. See Final Act. 7.
The teachings of Kanios, therefore, do not solve the problem caused
by the absence of any teaching or suggestion by Paul concerning the release
rate or duration of any active agent from its acrylic block copolymer system.
The Examiner reasons that a release duration of amphetamine “of from
about 6 to about 12 hours” is somehow an inherent property of the teachings
of Paul, but we can discern no teaching or suggestion of Paul to support the
otherwise speculative conclusion that its acrylic block copolymer
compositions must necessarily deliver methamphetamine (or any other drug)
over that interval. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349
(Fed. Cir. 2002) (holding that inherency can only be established when “prior
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art necessarily functions in accordance with, or includes, the claimed
limitations”). The Examiner has adduced no evidence of record that teaches
or suggests that the acrylic block copolymers of Paul would necessarily
deliver amphetamine “over a period of time of from about 6 to about 12
hours,” as recited in claim 1.
For the same reason, the Examiner’s effort to shift to Appellant the
burden of showing that the claimed release duration of amphetamine from
the acrylic block copolymers of Paul is not inherent in those compositions is
improper. It is true that:
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent characteristic
of the prior art, it possesses the authority to require the applicant
to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.

In re Best, 562 F.2d 1252, 1254–55 (C.C.P.A. 1977) (quoting In re
Swinehart, 439 F.2d 210, 212–13 (C.C.P.A. 1971)). However, before
employing this burden-shifting mechanism, the Examiner must first
articulate a reason, supported by evidence of record, demonstrating, in this
instance, that the acrylic block copolymer compositions of Paul would
necessarily possess the functional property of releasing amphetamine over
an interval of approximately 6 to 12 hours, as required by the claims. The
Examiner did not provide sufficient evidence that amphetamine, when
combined with the polymer of Paul in the stated amounts, would necessarily
possess the recited release properties. Having failed to do so, the Examiner
has failed to establish an initial prima facie case of obviousness, and
therefore may not attempt to shift the burden of proof to Appellant. See In
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re Deuel, 51 F.3d 1552, 1557 (Fed. Cir. 1995) (holding that “[o]nly if this
burden [i.e., of initially establishing a prima facie case of obviousness] is
met does the burden of coming forward with rebuttal argument or evidence
shift to the applicant”).
We therefore conclude that the Examiner has failed to establish a
prima facie case of obviousness with respect to the claims on appeal.
Because we find this issue to be dispositive of the appeal, we do not reach
Appellant’s additional arguments.

CONCLUSION
The rejection of claims 1, 4–6, 8, 10–12, 14, 16, and 20 as
unpatentable under 35 U.S.C. § 103 is reversed.

REVERSED

Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 4–6, 8, 10–12,
14, 16, 20
103 Paul, Kanios 1, 4–6, 8,
10–12, 14,
16, 20