Jun Liao et al.

Patent Trials and Appeals Board

Aug 14, 2019

14810962 - (D) (P.T.A.B. Aug. 14, 2019)

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.
14/810,962 07/28/2015 Jun Liao 041457-1118 6695
22428 7590 08/14/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
BASQUILL, SEAN M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
08/14/2019 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 JUN LIAO, JILIN ZHANG,
PUCHUN LIU, and STEVEN DINH
____________

Appeal 2018-004631
Application 14/810,962
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims as obvious and on the ground of non-statutory

1 Appellant is the Applicant, Noven Pharmaceuticals, Inc., which, according
to the Brief, is the real party in interest. Appeal Br. 3. We have considered,
and herein refer to, the Specification of July 28, 2015 (“Spec.”); Final Office
Action of May 2, 2017 (“Final Act.”); Advisory Action of July 10, 2017
(“Adv. Act.”); Appeal Brief of November 1, 2017 (“Appeal Br.”);
Examiner's Answer of January 26, 2018 (“Answer”); Reply Brief of March
23, 2018 (“Reply Br.”); and the transcript of the Oral Hearing held July 2,
2019 (“Tr.”)

Appeal 2018-004631
Application 14/810,962
2
obviousness type double patenting. We have jurisdiction under
35 U.S.C. § 6(b). We AFFIRM.
STATEMENT OF THE CASE
Claims 1, 3–5, 10, 11, and 21–23 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief. Claim 1, the sole independent
claim, is representative of the claims on appeal, and reads as follows:
1. A composition for the transdermal delivery of an amine
drug in the form of a flexible finite system for topical application,
comprising a polymer matrix comprising an amine drug and a
non-reactive silicone-containing acrylic polymer, wherein
the amine drug is selected from amphetamine,
methylphenidate, rivastigmine, paroxetine and clonidine,
the non-reactive silicone-containing acrylic polymer is
made from (i) one or more non-reactive acrylic monomers and
(ii) one or more non-reactive silicone-containing acrylic
monomers selected from 3-acryloxypropyl
tri(trimethylsiloxy)silane, 3-methacryloxypropyl
tri(trimethylsiloxy)silane, and mono-vinyl terminated
polydimethylsiloxane, and
the non-reactive monomers and the non-reactive silicone-
containing acrylic polymer do not react with amine groups of the
amine drug.
Appeal Br. 21 (Claims Appendix).
Appellant seeks review of the following rejections made by Examiner:
I. Claims 1, 3–5, 10, 11, and 21–23 under 35 U.S.C. § 103(a) as
unpatentable over Loubert2 in view of Li.3
II. Claims 1, 3–5, 10, 11, and 21–23 on the ground of non-statutory
obviousness type double patenting over claims 1, 2, and 4–16 of
co-pending application No. 14/206,369 in view of Loubert and Li.

2 Loubert et al., US 8,124,689 B2, issued Feb. 28, 2012 (“Loubert”).
3 Li et al., US 5,288,827, issued Feb. 22, 1994 (“Li”).
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III. Claims 1, 3–5, 10, 11, and 21–23 on the ground of non-statutory
obviousness type double patenting over claims 1–13 of co-pending
application No. 14/654,919 in view of Loubert and Li.
I. Obviousness over Loubert and Li
The Examiner has rejected claims 1, 3–5, 10, 11, and 21–23 under
35 U.S.C. § 103(a) as being unpatentable over Loubert and Li. Examiner
finds that Loubert teaches that “silane/acrylate pressure sensitive adhesives
are useful as transdermal drug delivery systems in accordance with well-
known techniques.” Final Act. 5. Examiner finds that Loubert teaches a list
of active agents for inclusion into the pressure sensitive adhesive that
include “the instantly claimed clonidine, amphetamine, and paroxetine.” Id.
(citing Loubert 17:21, 17: 67, and 18: 30). Examiner finds that Loubert even
exemplifies a drug containing a tertiary amine moiety (ketoconazole) in a
pressure sensitive adhesive matrix. Id. Examiner finds that Loubert teaches
the individual components but acknowledges that “the instantly claimed 3-
methylacryloxy propyl tri(trimethylsiloxy)silane and 2-ethylhexyl acrylate
[combination] is not recited” in Loubert. Id. at 6.
Examiner finds that Li teaches pressure sensitive adhesives containing
copolymers of siloxy silanes and alkyl (meth)acrylates. Final Act. 7 (citing
Li 1:9–15, 3:66–68, 6:34–46, 10:21–24, examples 4 and 5). Examiner finds
that the most preferred combination in Li contains the 3-methacryloxypropyl
tris(trimethylsiloxy)silane and 2-ethylhexyl acrylate. Id. (citing Li 4:15–28,
10:21–24).
Examiner concludes that it would have been “prima facie obvious to
select a known material [i.e. drug] for incorporation into a composition,
based on its recognized suitability for its intended use.” Final Act. at 7
(citing Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945)
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(“Reading a list and selecting a known compound to meet known
requirements is no more ingenious than selecting the last piece to put in the
last opening in a jig-saw puzzle.”)).
The issue is: Does the preponderance of evidence of record support
Examiner’s conclusion that the combination of Loubert and Li renders a
pressure sensitive adhesive containing a non-reactive silicone and acrylic
polymer complex in conjunction with one of the recited amine drugs
obvious?
Findings of Fact
We agree with and adopt Examiner’s factual findings and conclusion,
as set out in the Final Action and Answer. We provide the following factual
findings for reference convenience:
FF1. Li teaches “a pressure sensitive adhesive for use in medical practice,
especially in transdermal and transmucosal drug delivery systems.”
Li 3:22–24. Li teaches that the most preferred copolymer is a
combination of 3-methacryloxypropyl-tris(trimethysiloxy)-silane and
2-ethylhexyl acrylate. Li 10:17–24, 12:21–13:10 (Examples 4 and 5);
see Final Act. 7.
FF2. Li teaches that transdermal drug delivery systems are frequently
“limited to certain drugs that possess the favored physics-chemical
properties for skin permeation.” Li 1:42–54. Li teaches that the use
of permeation enhancers extends the availability of the transdermal
administration route to additional bioactive agents. See id. 1:54–60.
FF3. Loubert teaches a silicone-containing pressure sensitive adhesive
composition. Loubert 14:1–26. Loubert teaches that “[t]he hybrid
compositions . . . to prepare PSA [pressure sensitive adhesive] films
for use as tapes or transdermal drug delivery systems in accordance
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with well-known coating, or application, techniques.” Loubert 15:8–
11; Final Act. 5.
FF4. Loubert teaches numerous active agents that can be incorporated into
its transdermal delivery substrate. See Loubert 16:58–19:10; see Final
Act. 5. Loubert lists amphetamine (Loubert 17:67), paroxetine (id.
18:30), and clonidine (id. 17:21) a suitable active agents for
incorporation into the transdermal delivery system.
Analysis
Appellant contends that Examiner has (1) not set out prima facie case
(Appeal Br. 10–13), (2) that the combination of references does not
recognize the problem addressed by inventors (id. at 13–16), and (3) that the
composition as claimed exhibits improved properties that could not have
been predicted (id. at 16–17). We address Appellant’s contentions below.
(1) the prima facie case
We are not persuaded by Appellant’s contention that Examiner has
not set out a prima facie case based on Loubert and Li. Li teaches a pressure
sensitive adhesive that preferably contains 3-methacryloxypropyl-
tris(trimethysiloxy)-silane and 2-ethylhexyl acrylate as copolymer
combination. FF1; Final Act. 7. Li additionally teaches that the selection of
drug for incorporation into the pressure sensitive adhesive would be any
drug known to possess suitable skin permeation properties. FF2; Final
Act. 7. Thus, Li teaches the particular copolymer combination as claimed
and instructs the artisan to incorporate those drugs that are known to be
suitable for transdermal delivery. Examiner relies on Loubert for teaching a
pressure sensitive adhesive composition that, like Li, are made up of acrylic
monomers and silicon-containing acrylic monomers. Final Act. 5 (“The
TDDS [trans-dermal delivery system] exemplified [in Loubert] as containing
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ketoconazole combine various amounts of PDMS (silanol endblocked
polydimethylsiloxane) and 3-methacryolyloxypropyldimethylchlorosilane
copolymers with 2-ethylhexyl methacrylate and methacrylate monomers,
addressing the silicone containing acrylic monomer and acrylic monomer
limitations of instant Claims”). Examiner recognizes that Loubert does not
specifically teach the copolymer combination as recited in the claim, but
relies on Li for this combination. Ans. 6; Final Act. 6. Recognizing that Li
does not disclose a list drugs and only instructs to select those drugs that are
known to be skin permeable, Examiner relies on Louberts’ teachings for a
list of drugs known for their suitability for incorporation into a pressure
sensitive adhesive for administration. See FF4; Ans. 5 (“transdermal drug
delivery systems [of Loubert] incorporate a backing layer and a release liner.
. . . Particular active agents taught as being usefully incorporated into such
transdermal drug delivery systems include each of the instantly claimed
clonidine, amphetamine, and paroxetine.”). Examiner explains that “Li
establishes the representative species encompassed by the claims is merely
an alternative pressure sensitive adhesive falling within the generic teaching
of Loubert” which teaches that “any of clonidine, amphetamine, or
paroxetine may suitably be formulated with any of a wider variety of
silane/acrylate pressure sensitive adhesives.” Ans. 6. Examiner further
explains that in order to find a prima facie case of obviousness “it is not
necessary that the prior art suggest the combination to achieve the same
advantage or result discovered by the appellant.” Ans. 7 (citing In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006)).
We agree with the Examiner’s position that “the law does not require
that the references be combined for the reasons contemplated by the
inventor.” In re Beattie, 974 F.2d 1309, 1312 (Fed.Cir.1992). Here, the
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rejection is based on the combined teachings of Loubert and Li. As
discussed above Li teaches a pressure sensitive adhesive formulation that
exemplifies the adhesive contemplated by the present claims and instructs
that it be used with drugs that are known to have the requisite skin
permeation requirements for transdermal application. FF1–FF2. Lambert
similarly teaches a pressure sensitive adhesive and provides a list of drugs
that are known to be suitable for transdermal application. FF3–FF4. Thus,
based on this combination we agree with Examiner that it would have been
obvious to arrive at a pressure sensitive adhesive as disclosed in Li that
incorporates any one of the suitable drugs disclosed in Loubert. Because we
agree with Examiner that the pressure sensitive adhesive composition as
claimed is an obvious combination of the references we also agree with
Examiner that the limitation of “the non-reactive monomers and the non-
reactive silicone-containing acrylic polymer do not react with amine groups
of the amine drug” is an inherent feature associated with the pressure
sensitive adhesive composition. In other words, the pressure sensitive
adhesive taught in Li has the recited feature of “the non-reactive monomers
and the non-reactive silicone-containing acrylic polymer do not react with
amine groups of the amine drug” because that is a quality inherent to the
structure of monomers making up the pressure sensitive adhesive. “Products
of identical chemical composition cannot have mutually exclusive
properties.” In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). A chemical
composition and its properties are inseparable. Therefore, if the prior art
teaches the identical chemical structure, the properties applicant discloses
and/or claims are necessarily present. Id. Having found no error with
Examiner’s prima facie case of obviousness based in the combination of
Loubert and Li we next turn to Appellant’s other contentions.
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(2) not recognizing the problem addressed by inventors
Appellant contends that “Loubert and Li disclose silicone-containing
acrylic polymers that are outside the scope of the claims and that would be
reactive with amine drugs, and neither teach or suggest to avoid using such
polymers when formulating an amine drug in particular.” Appeal Br. 11.
We are not persuaded by Appellant’s contention because as Examiner
pointed out one of the most preferred formulations in Li includes an
adhesive composition that is non-reactive and is encompassed by the claim.
Ans. 7; see FF1. Appellant does not contest that Li’s preferred embodiment
is a non-reactive copolymer composition. Tr. 4:12 (“[T]he preferred
embodiment of Li is non-reactive.”). As Examiner explains, the fact that
some embodiments disclosed in the references may fall outside the scope of
the claims is irrelevant to a finding of obviousness based on the combination
of Loubert and Li. Ans. 9.
Appellant contends that Examiner’s cited references does not
recognize the problem addressed when formulating amine drugs –– namely
the issue with peel force. Appeal Br. 13; Tr. 4:5–8 (“[W]e address a
problem that is not recognized in the prior art which is this peel force
problem and other problems where the amine drugs are reactive with the
silicon polymers.”). Appellant cites Leo Pharmaceutical Products, Ltd v.
Rea, 726 F.3d 1346, 1349-50 (Fed. Cir. 2013) and In re Omeprazole Patent
Litigation, 536 F.3d 1361 (Fed. Cir. 2008) to support the contention that the
art needs to recognize the problem solved by Appellant. See Appeal Br. 14.
We are not persuaded. In Leo Pharmaceutical, there was evidence in
the record that the combination of vitamin D analog with a corticosteroid
had stability problems, and numerous articles taught away from making the
combination in the first place. See Leo Pharmaceutical, 726 F.3d 1353
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(“These articles taught away from mixing topical vitamin D formulations
with other drugs.”), 1354 (“Leo Pharmaceuticals presented experimental
evidence . . . that each of these ingredients harmed the storage stability of the
vitamin D analog and corticosteroid combination.”). Here, there is
insufficient evidence in the record to establish that one of ordinary skill in
the art would be discouraged from mixing an amine-containing drug with
any of the adhesive compositions disclosed in either Loubert or Li.
The Specification is not helpful on this front either, as the
Specification sets out that “silicone pressure-sensitive adhesives that include
silanol groups may be reactive with drugs that have a reactive amine moiety,
and may be associated with poor physical properties and chemical stability
problems, such as, for example, a release liner peel force that increases over
time.” Spec. ¶ 6. The fact that some drugs may be reactive with silanol
groups does not establish that one of ordinary skill in the art would not use
such a composition as a drug delivery vehicle. The Specification suggests
that peel force may be a problem with some types of moieties but does not
establish that all amine drugs react with silanol groups that would dissuade
one of ordinary skill in the art away from making the combination.
Teaching that some amine-containing drugs may have a problem when
mixed with some adhesives is not a teaching away from using any of the
adhesives disclosed and Loubert or Li. We note that the claims do not recite
maintaining a particular level of peel force, nor a particular length of storage
time — all that is required by the claim is that the amine drug is formulated
with non-reactive moieties. Here, Examiner established that one of Li’s
preferred embodiments contains an adhesive made of non-reactive
monomers and suggest adding drugs that are known to permeate the skin.
FF1–FF2. Examiner explains that “[t]he record at present fails to address
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the threshold analysis, i.e., that the so-called ‘peel force problem’ was a
persistent one recognized by those of ordinary skill in the art, therefore
appellants’ assertions of the invention claimed addressing the ‘peel force
problem’ are unpersuasive.” Ans. 7–8. We agree with Examiner that the
evidence in the record is insufficient to establish that the peel force issue was
a recognized problem.
We are also not persuaded by Appellant’s reliance on In re
Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008). Appeal
Br. 14. In Omeprazole the issue was the inclusion of an additional
subcoating component to improve the stability of the active agent. See
Omeprazole, 536 F.3d at 1373–74. Because “the problem [of omeprazole
degradation had] not been previously known, there would have been no
reason to incur additional time and expense to add another layer, even
though the addition [subcoating] would have been technologically possible.”
MPEP 2143(I)(A), at Example 3; see Appeal Br. 14. The facts in the present
case differ from the facts in Omeprazole because the claims do not require
the inclusion of any additional agent to improve the function of a known
composition. Instead, the rejection as formulated by Examiner is that is it
obvious to incorporate a drug known to be suitable for administration by
transdermal route as disclosed in Loubert with the adhesive composition
taught in Li. See FF1–FF4. The fact that some drugs may be more reactive
with silanol groups, and thereby be more prone to tearing of the adhesive
layer, does not establish that one of ordinary skill in the art would not use
such a composition as a drug delivery vehicle. See Spec. ¶ 6. It is also
important to note that claim 1 does not recite a composition having a
particular peel force requirement.
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On this record, we are not persuaded that Appellant has demonstrated
with sufficient evidence that there is an unrecognized problem that is solved
by the claimed invention. Accordingly, we conclude that the evidence cited
by Examiner supports a prima facie case of obviousness with respect to
claim 1.
(3) unexpected improved properties
We next address Appellant’s unexpected results argument.
Appellant’s content that
the experimental data reported in the specification,
compositions comprising amine drugs formulated in pressure
sensitive adhesives that contain reactive silanol groups exhibit a
peel force that increases significantly over time, making it
difficult to remove the release liner for use without damaging
the polymer matrix, and compromising the integrity of the
transdermal drug delivery system.
Appeal Br. 16. The result of Example 3, is reproduced below:

The table above shows “that the peel force for the polymer B composition
[containing non-reactive silanol] remained stable and low while that of the
Daytrana® product increased over time.” Spec. ¶ 95.
Unexpected results must be “commensurate in scope with the degree
of protection sought by the claimed subject matter.” In re Harris, 409 F.3d
1339, 1344 (Fed. Cir. 2005). The burden of demonstrating unexpected
results rests on the party asserting them. In re Klosak, 455 F.2d 1077, 1080
(CCPA 1972). That burden has not been carried here because Appellant has
not established that the results achieved using the recited amine drugs were
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unexpectedly superior compared to the closest prior art, which is the
preferred composition disclosed by Li. See In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991). As Examiner explains, the data presented in
the Specification is not a comparison to the closet prior art. Ans. 9. We note
that in Example 3 of the Specification the peel force with Daytrana begins to
increase dramatically only after 2 months — the claims, however, do not
recite a particular shelf life and during the earlier time frame of 1–2 months,
there is little or no difference between the samples. Accordingly, the
argument with respect to shelf life and peel force is not commensurate with
the scope of claim 1.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1 and Appellant has not
provided sufficient persuasive evidence to rebut the prima facie case. As
Appellant does not argue the claims separately, claims 3–5, 10, 11 and 21–
23 fall with claim 1. 37 C.F.R. § 41.37 (c)(1)(iv).
II.–III. Obviousness Type Double Patenting
With respect to the obviousness type double patenting rejections of
claims 1, 3–5, 10, 11, and 21–23 over claims 1, 2, 4–16 of co-pending
application No. 14/206,369 in view of Loubert and Li, and over claims 1–13
of co-pending application No. 14/654,919 in view of Loubert and Li,
Appellant contends that the combination of Loubert and Li does not teach or
suggest the polymer matrix subject matter of the instant claims. Appeal Br.
17—19.
For the reasons discussed above with respect to the obviousness
rejections based on the combination of Loubert and Li (see I.), and those
provided by Examiner (see Final Act. 12–15; see Ans. 4–9) we are not
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persuaded by Appellant’s contention and agree with Examiner’s conclusion
that the present claims are not patentably distinct from those set out in the
’369 and ’919 application.
SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
unpatentable over Loubert in view of Li. Claims 3–5, 10, 11, and 21–23
were not separately argued and fall with claim 1.
We affirm the rejection of claims 1, 3–5, 10, 11, and 21–23 on the
ground of non-statutory obviousness type double patenting over claims 1, 2,
and 4–16 of co-pending application No. 14/206,369 in view of Loubert and
Li.
We affirm the rejection of claims 1, 3–5, 10, 11, and 21–23 on the
ground of non-statutory obviousness type double patenting over claims 1–13
of co-pending application No. 14/654,919 in view of Loubert and Li.

TIME PERIOD FOR RESPONSE
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