Noven Pharmaceuticals, Inc.

Patent Trials and Appeals Board

Nov 24, 2020

2020001010 (P.T.A.B. Nov. 24, 2020)

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.
14/141,946 12/27/2013 Keita Mori 041457-1043 7983
22428 7590 11/24/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
SHIN, MONICA A
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
11/24/2020 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 KEITA MORI and PUCHUN LIU
____________

Appeal 2020-001010
Application 14/141,946
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a flexible, finite system for the transdermal delivery of an active
agent. Appellant appeals the Examiner’s rejection of claims 1, 3–14, 17, and
19–25 under 35 U.S.C. § 103(a) and for obviousness-type double
patenting.1,2 We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42.
Appellant identifies “Noven Pharmaceuticals, Inc.” as the real party-in-
interest. Appeal Br. 3.
2 Oral argument was heard on September 14, 2020; a transcript of the
hearing (“Hr’g Tr.”) is a part of the record.
Appeal 2020-001010
Application 14/141,946

2
STATEMENT OF THE CASE
Claims 1 and 21 are independent claims. Claim 1, which is
representative, is reproduced below:
1. A composition for the transdermal delivery of an
NSAID in the form of a flexible finite system for topical
application, comprising:
(a) a polymer matrix comprising
(i) a therapeutically effective amount of an NSAID;
(ii) a silicone polymer;
(iii) an acrylic polymer or an acrylic block
copolymer; and
(iv) a styrene-isoprene-styrene block copolymer,
and
(b) a flexible, occlusive backing layer comprising a fabric
backing material coated with an occlusive coating comprising a
rubber-based polymer selected from polyisobutylene polymers
and styrene-isoprene-styrene (SIS) block copolymers.
Appeal Br. 31 (Claims Appendix; formatting added). Claim 21 is similar,
but is broader and omits the detailed elements regarding the composition of
the recited polymer matrix. Id. at 32.
The Specification states that
The present invention relates generally to the transdermal
delivery of non-steroidal anti-inflammatory agents (NSAIDs),
and to compositions and methods for transdermally delivering
NSAIDs, such as may be desired for treating or reducing pain
and/or inflammation. The present invention also relates to a
flexible, occlusive backing material suitable for use with any
flexible, finite transdermal drug delivery system.
Spec. ¶ 2.
Appeal 2020-001010
Application 14/141,946

3
Regarding the first, above-quoted, claim element “(a),” which is a
polymer matrix comprising an NSAID active agent and three polymers, the
Specification states that “[t]he inventors have discovered that the polymer
blends described herein, comprising a silicone-based polymer and an acrylic
polymer and/or an acrylic block copolymer and, optionally, a styrene-
isoprene-styrene block copolymer, balances these competing properties [of
drug solubility and drug delivery] and achieves good drug flux without
requiring high drug loading.” Id. ¶ 72. The styrene-isoprene-styrene block
copolymer, however, is not optional in the claim.
Regarding the second claim element “(b),” which is a rubber-based
polymer-coated flexible occlusive backing layer, the Specification indicates
that this backing layer can be “a . . . monolayer of polyethylene” such as
3M’s CoTran 9719 material, or “a cloth.” Id. ¶¶ 74–75. In several
instances, the Specification identifies that such a backing material can be
“coated with an occlusive coating,” for example, “a polyisobutylene
coating.” Id. ¶¶ 10, 12. However, the Specification does not describe how
such a coating is applied or any physical characteristics or properties of such
a coating, beyond stating that “a flexible, occlusive backing layer can be
prepared by applying an occlusive coating to a fabric backing material.” Id.
¶ 80; see also Hr’g Tr. 6:22–7:2 (Appellant recognizing the Specification’s
lack of disclosure regarding how a coating is applied).3

3 During oral argument, Appellant agreed that a coating could be applied by,
for example, spraying, painting, and spreading, but equivocated regarding
application by melting, specifically “melt lamination,” which, as discussed
infra, is a technique disclosed in the cited prior art. Hr’g Tr. 6:22–8:2.
Appeal 2020-001010
Application 14/141,946

4
Regarding such a coated backing layer, the Specification compares the
“moisture vapor transmission rate (MVTR)” of an occlusive backing layer
“prepared by applying a polyisobutylene (PIB) coating to a cloth backing
material” (three different amounts (thicknesses, mg/cm2) of PIB coating) to a
Scotchpak 9732 polyester film laminate having a polyester layer and an
ethylene vinyl acetate copolymer layer (of unidentified thickness). Spec.
¶¶ 87–88 (Example 1). The related data show that the PIB-coated cloth
exhibited MVTRs (19.38, 42.63, and 302.25 “g/m2/day”) bookending a
single result produced by the Scotchpak 9732 (27.13 g/m2/day), depending
on the amount/thickness of the PIB (respectively 5, 4, and 3 mg/cm2 –– the
thicker the PIB, the lower the MVTR). Id. (see table).
In a second example, the Specification compares a PIB-coated cloth
(of unidentified PIB thickness) with a polyolefin/cloth laminated film
backing, Scotchpak 9732, and Yakuban Tape (the Flurbiprofen commercial
patch) (each of unidentified thickness) and states that “the PIB-coated cloth
backing achieves a drug flux comparable to that of the system with
Scotchpak® 9732 backing layer.” Id. ¶¶ 89–92 (Example 2), Fig. 1.
The following rejections are on appeal:
Claims 1, 3–6, 17, and 19–24 stand rejected under 35 U.S.C. § 103(a)
over Wakamatsu,4 Kanios,5 and Fleischer.6 Final Action 3–8.

4 US 2008/0089925 A1 (published Apr. 17, 2008) (“Wakamatsu”).
5 US 7,063,859 B1 (issued June 20, 2006) (“Kanios”).
6 US 2003/0125659 A1 (published July 3, 2003) (“Fleisher”).
Appeal 2020-001010
Application 14/141,946

5
Claims 1, 3–14, 17, and 19–24 stand rejected under 35 U.S.C.
§ 103(a) over Wakamatsu, Kanios, Fleischer, and Miranda.7 Final Action 9–
12.
Claims 1, 3–6, 17, and 20–25 stand rejected under 35 U.S.C. § 103(a)
over Wakamatsu, Kanios, Sharma,8 and Hsu.9 Final Action 12–20.
Claims 1, 3–14, 17, and 19–24 stand rejected on the ground of
obviousness type double patenting over claims 1–4 and 6–31 of Kanios
’281,10 Kanios, and Fleischer. Final Action 21–22.
As of the Final Action, claims 1, 3–14, 17, and 19–24 stood
provisionally rejected on the ground of obviousness type double patenting
over claims 1–20 of copending U.S. Application 15/351,616 (“the ’616
application), Wakamatsu, and Miranda. Final Action 22–23. We note, a
terminal disclaimer to the ’616 application was filed by Appellant and
approved by the Office on March 29, 2019. The Examiner does not
expressly acknowledge this in the Answer, but in her summary of the
rejections on appeal she does not list this rejection among the others.
Therefore, we understand this rejection to be withdrawn and we dismiss it as
moot.
DISCUSSION
I. LEGAL STANDARDS ON PATENTABILITY
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.

7 US 5,656,286 (issued Aug. 12, 1997) (“Miranda”).
8 US 2004/0202704 A1 (published Oct. 14, 2004) (“Sharma”).
9 US 5,688,524 (issued Nov. 18, 1997) (“Hsu”).
10 US 8,815,281 B2 (issued Aug. 26, 2014) (“Kanios ’281”).
Appeal 2020-001010
Application 14/141,946

6
[Once] that burden is met, the burden of coming forward with evidence or
argument shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed.
Cir. 1992). Arguments made by Appellant in the Appeal Brief and properly
presented in the Reply Brief have been considered; arguments not so-
presented are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2017); see also Ex
parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) (“Any
bases for asserting error, whether factual or legal, that are not raised in the
principal brief are waived.”).
CLAIM INTERPRETATION
Regarding claim interpretation, the Patent Office applies the broadest
reasonable construction standard in prosecution proceedings. Cuozzo Speed
Tech., LLC v. Lee, 136 S. Ct. 2131, 2145 (2016). “[T]he words of a claim
‘are generally given their ordinary and customary meaning.’ . . . [T]he
ordinary and customary meaning of a claim term is the meaning that the
term would have to a person of ordinary skill in the art in question at the
time of the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1312–13
(Fed. Cir. 2005). “[A] claim must be read in view of the specification of
which it is a part.” Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d
1243, 1248 (Fed. Cir. 1998). “Absent claim language carrying a narrow
meaning, the PTO should only limit the claim based on the specification or
prosecution history when those sources expressly disclaim the broader
definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
“The patentability of a product does not depend on its method of
production. If the product in a product-by-process claim is the same as or
obvious from a product of the prior art, the claim is unpatentable even
though the prior product was made by a different process.” In re Thorpe,
Appeal 2020-001010
Application 14/141,946

7
777 F.2d 695, 697 (Fed. Cir. 1985). Limitations in product claims may
appear to be product-by-process limitations where only the recited product is
to be considered; however, some limitations describing a process of
manufacture connote structure, for example the claim term “injection
molded” connotes a clear structural significance to components of a knee
brace product. See In re Nordt Development Co., 881 F.3d 1371, 1375 (Fed.
Cir. 2018). In such circumstances, claim terms appearing to be product-by-
process limitations may be construed to give effect to the structure produced
by the recited process. Id. at 1376.
OBVIOUSNESS
When analyzing obviousness, “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). “[W]hen the question is whether a patent claiming the
combination of elements of prior art is obvious,” the answer depends on
“whether the improvement is more than the predictable use of prior art
elements according to their established functions.” Id. at 417. “If a person
of ordinary skill can implement a predictable variation [of a known work],
§ 103 likely bars its patentability.” Id. “In considering motivation in the
obviousness analysis, the problem examined is not the specific problem
solved by the invention but the general problem that confronted the inventor
before the invention was made.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006).
OBVIOUSNESS-TYPE DOUBLE PATENTING
The doctrine of obviousness-type double patenting is designed to
prevent an inventor from securing a second, later-expiring patent for the
Appeal 2020-001010
Application 14/141,946

8
same invention (and obvious variants thereof) claimed in an earlier,
commonly-owned patent. AbbVie Inc. v. Mathilda & Terrence Kennedy
Inst. of Rheumatology Tr., 764 F.3d 1366, 1373 (Fed. Cir. 2014). The
obviousness-type double patenting analysis is comparable to that under
35 U.S.C. § 103, and requires consideration of whether one of ordinary skill
would have considered the examined claims merely an obvious variation of
an invention claimed in an earlier patent. See In re Braat, 937 F.2d 589,
592–93 (Fed. Cir. 1991).
With these standards in mind, we address the Examiner’s rejections
and Appellant’s arguments thereover.
II. ANALYSIS
CLAIM INTERPRETATION
A prominent dispute in this appeal concerns the claim language “a
flexible, occlusive backing layer comprising a fabric backing material coated
with an occlusive coating.” See Appeal Br. 31, 32; see also Final Action
17–20 (addressing whether the scope of “coated” and “coating” includes
laminates and analyzing the Specification regarding the same); Appeal Br.
12–20 (arguing Examiner’s interpretation was “impermissibly broad” and
coatings must be “formed in situ” as a liquid such that “pre-formed”
laminated structures are not coated structures); Answer 4–6 (discussing the
meaning of the respective claim language); Reply Br. 2–5 (“The Rejections
Turn On Claim Construction.” (emphasis omitted)).
The claim recites “backing material coated with an occlusive coating.”
The Examiner interprets the claim term “coating” as meaning “a layer of any
substance spread over or covering a surface,” which the Examiner identifies
as a definition for coating in the Oxford English Dictionary (as accessed
Appeal 2020-001010
Application 14/141,946

9
online Aug. 11, 2017; not provided on the record on appeal). Answer 5.
The Examiner notes that the Specification does not expressly define the term
“coating,” more specifically, that neither the Specification nor claims
“redefine” the term “coating” so as to limit it to a structure formed in situ, of
a liquid, which is then dried. Id. The Examiner notes that the Specification
provides Example 1, where a cloth was coated with PIB, but that this
example does not provide any details about the process by which PIB was
added to the cloth. Id. The Examiner concludes that laminated films are
within the scope of coatings because, even though there are some
differences in the processes of laminating and coating, there is also some
overlap in such processes. Id. at 5–6. Ultimately, the Examiner finds the
claims’ recitation of a coated coating is not a process limitation, but is a
product-by-process limitation, and finds that there is no evidence
establishing that forming an occlusive backing layer by laminating, versus
by applying liquid and drying as a coating, results in a materially different
product. Id. at 6 (discussing Spec. Example 1: “it is unclear whether
differences in the observed moisture vapor transmission rates are as a result
of the polyisobutylene versus polyester or are a result of different processes
for applying the polymers.”).
Appellant takes issue with the Examiner’s reliance on a general
dictionary definition of “coating,” and argues that, in the field of the
invention, those of skill would understand the term to be more narrowly
defined, such that
the occlusive coating of the recited backing layers refers to a
coating that is formed in situ, such as by applying the coating
material in a liquid state and then drying, and so does not read on
Appeal 2020-001010
Application 14/141,946

10
a backing comprised of separate layers that are pre-formed and
then laminated together.
Appeal Br. 13. As support for this position, Appellant submits a declaration
under 37 C.F.R. § 1.132 from Dr. Jun Liao,11 along with a brochure for the
3M industrial coated fabric products,12 a portion of the book Coated Textiles
by Ashish Kumar Sen,13 and a print out of a webpage by Mid-Mountain
Materials, Inc. directed coated fabrics and textiles.14
Having considered the Examiner’s and Appellant’s positions and
evidence, we conclude that the broadest reasonable interpretation of the
claim language “a flexible, occlusive backing layer comprising a fabric
backing material coated with an occlusive coating” is that it is a product-by-
process limitation, where the backing layer product is an occlusive material
that includes fabric backing material and “comprising a rubber-based
polymer selected from polyisobutylene polymers and styrene-isoprene-
styrene (SIS) block copolymers,” provided over that fabric. Structurally, a
coating, as explained by Appellant’s witness Dr. Liao, is a material applied
to, or provided on, another material. Liao Declaration ¶ 6. Dr. Liao
explains that the process of coating involves forming the coating in situ,
“such as by applying the coating material in a liquid state and then drying”
and that such a process “could ‘saturate’ a fabric.” Id. ¶¶ 6–7 (citing Sen

11 Declaration Under 37 C.F.R. § 1.132 by Jun Liao, dated July 26, 2017
(“Liao Declaration”).
12 3M, Industrial Coated Fabrics (2007) (“3M”).
13 Ashish Kumar Sen, COATED TEXTILES, PRINCIPLES AND APPLICATIONS,
xix–xx, 69, 95–96 (2nd ed. 2008) (“Sen”).
14 Mid-Mountain Materials, Inc., Coated Fabrics and Textiles, http://mid-
mountain.com/products/armatex/ (last accessed June 2, 2017) (“Mid-
Mountain”).
Appeal 2020-001010
Application 14/141,946

11
and 3M). Dr. Liao states that this process is distinct from lamination and,
without explanation, other than to identify the processes are different, states
that a material that is coated onto a substrate is distinct from a laminated
material. Id. ¶¶ 6–8 (further citing Mid-Mountain).
Appellant argues that a laminated material has structurally distinct
layers, appearing to suggest that a coated material does not. Appeal Br. 15.
However, Appellant’s expert does not state this to be the case. Instead,
Dr. Liao indicates that in fabrics coated by a coating process the material for
coating saturates the fabric. Liao Declaration ¶ 7.
Appellant’s literature evidence also does not establish that there is a
structural or physical difference between a material that is coated onto a
fabric versus the same material that is laminated onto that fabric, or the
resulting product. It just establishes the processes to obtain a product that is
made up of two materials, one being atop the other, are different. For
example, Sen explains that coatings are formed by applying a viscous liquid
or formulated compound to a substrate and that laminated layers are formed
by bonding a pre-prepared film or membrane with a substrate by adhesive,
heat, or pressure, and that “[s]everal methods of production are used to
manufacture a wide range of coated or laminated fabrics. Broadly, they are
spread coating, dip coating, melt coating, and lamination,” and Kanios
explains that the lamination process may include flame or heating bonding
materials together. Sen xix, 69, 95–96; Kanios 5:59–6:10.
Moreover, to the extent Appellant might be suggesting that the
Specification’s Examples 1 and 2 establish a structural difference between
laminated and coated backings, we disagree that this evidence supports such
Appeal 2020-001010
Application 14/141,946

12
a conclusion. Example 1 provides data on a physical property, MVTR, of a
coated fabric compared to a polyester laminate. Spec. ¶¶ 87–88. The data
show that, as compared to a set thickness of a single example of the
polyester film laminate, one may adjust the thickness (mg/cm2) of the
coated material to have an MVTR greater or less than that of the laminate.
The Specification’s second Example 2 also specifically states that a PIB-
coated cloth achieves a drug flux comparable (similar to) that of a laminate.
Spec. ¶¶ 89–92. This evidence establishes only that products achieved using
the two processes can have similar or different MVTR and drug flux. The
comparison of these properties does not establish anything with respect to
the structure differences or similarities of these two products
Thus, the record does not evidence a physical or structural difference
between a layer of material that is coated onto a substrate, e.g., a fabric, and
a layer that is laminated onto that same substrate based on the process of
producing such products. For this reason, we do not interpret the claim
language “a flexible, occlusive backing layer comprising a fabric backing
material coated with an occlusive coating” to confer any special meaning to
the recited “occlusive coating” merely by way of it having been applied by
coating versus another process.
OBVIOUSNESS
Appellant addresses the Examiner’s three obviousness rejections
together, therefore, we do the same. Appeal Br. 8–28.
Regarding independent claims 1 and 21, the Examiner determines that
Wakamatsu teaches an adhesive, NSAID (e.g., flurbiprofen) drug-delivering
patch, having the claimed polymer matrix (e.g., of PIB, acrylic polymer,
and/or SIS block copolymer, and silicone polymer adhesive), with a backing
Appeal 2020-001010
Application 14/141,946

13
fabric, but not the specifically claimed occlusive backing system. Final
Action 4–6 (citing Wakamatsu ¶¶ 1, 16, 18, 19, 45, 51, 52).
The Examiner further cites Kanios as also directed to a drug
delivering patch (also for NSAIDs) similar to Wakamatsu’s, and further
teaching a flexible and stretchable backing layer, of woven or non-woven
fabric, having a barrier film layer of any material generally applicable to use
as the backing layer in a transdermal drug delivery system. Id. at 6–7 (citing
Kanios, Abstract, 4:51–59, 7:52–56, 9:54–64); see also Kanios 8:64–9:6
(disclosing the NSAID drug flurbiprofen as suitable for its system). Kanios
describes its backing layer as having an inner surface including “an
impermeable polymeric barrier film” to “prevent the active agent and/or
solvent and/or carrier composition . . . from penetrating into the backing
layer” and an outer surface. Kanios, Abstract, 1:66–2:2, 2:18–21, 4:44–50
7:26–29. Kanios further explains that “any conventional or known means of
bonding,” such as non-adhesive techniques and adhesive techniques, can be
used to join the impermeable barrier film to the backing layer, where non-
adhesive methods include flame or heating bonding. Id. at 5:59–6:10.
When adhesive techniques are used, Kanios states that “[s]uitable adhesives
include . . . polyisobutylenes,” and that low molecular weight, low viscosity
adhesives are preferred to permit this material to “remain fluid enough to
migrate slightly into the backing layer when applied,” where “penetration of
the adhesive into backing layer helps to ensure a bond.” Id. at 6:9–45.
Although Kanios teaches polyisobutylene adhesive, which is the same
material as in part (b) of claim 1, the Examiner finds that Kanios and
Wakamatsu do not specifically teach an occlusive coating comprises this
Appeal 2020-001010
Application 14/141,946

14
material and/or SIS block copolymer, as claimed. Final Action 7. The
Examiner determined that Fleischer, which is also directed to transdermal
delivery systems or, more specifically, to a device for manufacturing such
systems, teaches that “the backing layer can be any suitable material that is
impermeable to the contents of the reservoir compartment, the polymer
matrix, or the adhesive matrix” and “[s]uitable materials for backing films
are well known to those skilled in the art and include, but are not limited to,
. . . polyisobutylene.” Id. at 7 (citing Fleischer ¶ 52); see also Fleischer ¶ 53
(disclosing, like Wakamatsu, materials for the drug-eluting matrix include
silicone polymers and acrylate polymers), ¶ 58 (disclosing, like Wakamatsu
and Kanios, the NSAID drug flurbiprofen as suitable for its systems).
The Examiner determines that the skilled artisan would have been
motivated to use barrier films or layers as taught by Kanios with
Wakamatsu’s patch device because the two references disclose similar
devices for similar uses and Kanios’s barriers provide strength and support
to anchor other components in a system, but which do not interfere with
functionality or movement of the device. Final Action 7–8. Similarly,
Fleischer also teaches a similar device and identifies a suitable material for a
barrier film/layer. Id. at 8. The Examiner determines that a skilled artisan
would have had a reasonable expectation of success in combining these
teachings. Id.
Regarding the same claims, but also dependent claims 7–14, which
are directed to more specific ranges for amounts of active agent, polymer
components, and drug release duration, the Examiner adds Miranda to the
above-discussed prior art combination. Final Action 9. The Examiner
Appeal 2020-001010
Application 14/141,946

15
determines that Miranda is directed to a drug (e.g., flurbiprofen in an amount
of 0.1–50% by wt.) delivering transdermal patch, like the other cited
references, and teaches that a drug delivery rate from a
polysiloxane/polyacrylate adhesive matrix can be controlled and adjusted by
varying the blend of these two polymers, where polysiloxane can be adjusted
from about 9–97% (by wt.) and the acrylate polymer can be adjusted from
about 5–85% (by wt.), where the preferred ratio of these materials is from
about 2:98 to about 96:4 polyacrylate-to-polysiloxane. Id. at 10–12 (citing
Miranda, Abstract, 3:31–40, 3:48–52, 3:64–4:6, 4:15–35, 4:44–47, 10:37–
40, 13:4–40, 32:56–59). The Examiner determines that, because Miranda
explains that adjustments to the ratio of these polymers controls drug
release, the claimed ranges would be arrived at by routine optimization. Id.
at 11–12. Further, the Examiner determines that the claimed release
durations were obvious in view of Miranda’s disclosure that drug release can
be controlled to extend over a prolonged period of time; the release duration
is also routinely optimizable for pain control in this way. Id. at 12.
Regarding the same claims and also dependent claim 25, which is
directed to the occlusive coating comprising SIS block copolymer, the
Examiner cites the initial prior art combination discussed above and adds
Sharma and Hsu. Final Action 12–17. The Examiner determines that
Sharma, which is directed to a transdermal patch for drug (e.g., NSAID)
delivery, teaches providing an impenetrable, minimally permeable layer to
restrain the drug and that a suitable material is styrene-isoprene copolymers.
Id. at 16 (citing Sharma, Abstract, ¶¶ 79, 81); see also Sharma ¶¶ 15, 55–63
(teaching acrylate, silicone, and SIS block copolymer drug storage
Appeal 2020-001010
Application 14/141,946

16
layers), 69 (disclosing NSAIDs as suitable drugs). The Examiner further
cites Hsu as confirming SIS block copolymer as suitable for backing
materials in transdermal patches. Final Action 16 (citing Hsu, Abstract,
3:52–55). The Examiner determines that “it would have been clear to one of
ordinary skill in the art” to use such materials for similar structures and
purposes in the Wakamastu and Kanios devices. Id. at 17.
We find the Examiner provides sufficient evidence to establish the
prima facie obviousness of the claimed subject matter and turn to
Appellant’s arguments below.
As noted above, Appellant’s primary argument is that the Examiner’s
rejections “rest on a legally incorrect claim construction that is broader” than
the claim term “coating” allows. Appeal Br. 8–9, 12–23. As discussed
above, the record does not support according the claim element “coating,” or
“a fabric backing material coated with an occlusive coating” a special
meaning that would make such an occlusive material on a fabric substrate
non-obvious over the same material applied to the same substrate via
lamination or as a liquid adhesive.
Regarding product-by-process claims and limitations, MPEP § 2113.II
states (emphasis added):
“The Patent Office bears a lesser burden of proof in
making out a case of prima facie obviousness for product-by-
process claims because of their peculiar nature” than when a
product is claimed in the conventional fashion. In re Fessmann,
489 F.2d 742, 744 . . . (CCPA 1974). Once the examiner
provides a rationale tending to show that the claimed product
appears to be the same or similar to that of the prior art,
although produced by a different process, the burden shifts to
applicant to come forward with evidence establishing an
Appeal 2020-001010
Application 14/141,946

17
nonobvious difference between the claimed product and the
prior art product. In re Marosi, 710 F.2d 799, 803 . . . (Fed. Cir.
1983) (The claims were directed to a zeolite manufactured by
mixing together various inorganic materials in solution and
heating the resultant gel to form a crystalline metal silicate
essentially free of alkali metal. The prior art described a process
of making a zeolite which, after ion exchange to remove alkali
metal, appeared to be “essentially free of alkali metal.” The court
upheld the rejection because the applicant had not come forward
with any evidence that the prior art was not “essentially free of
alkali metal” and therefore a different and nonobvious product.).
The Examiner has met her burden, as summarized in the MPEP, by showing,
as set forth above, that the same occlusive material as claimed (e.g., PIB or
SIS) was known to be applied (e.g., by flame bonding and as liquid
adhesive, no less) to a backing fabric of a transdermal, drug-releasing patch
as claimed, to incorporate the same drugs (e.g., flurbiprofen) as claimed.
Appellant’s Specification evidences that laminated and coated occlusive
materials have similar and overlapping physical properties, dependent on
their thickness. See supra Discussion (regarding claim interpretation and
Spec. Examples 1 and 2). Thus, the burden of showing some non-obvious
difference between the claimed coated coating of occlusive material on a
fabric, and the prior art’s taught occlusive material on a fabric, shifted to
Appellant, and Appellant has not made such a showing. Appellant has
established only that a coating is “formed in situ, such as by applying the
coating material in a liquid state and then drying,” however, this says
nothing about why such an in situ applied material would be different and
non-obvious over the same material applied in a different (yet related)
fashion to the same substrate for the same purpose. See Appeal Br. 13–18;
Liao Declaration (and references cited therein).
Appeal 2020-001010
Application 14/141,946

18
Appellant also argues that Wakamatsu’s disclosure of active agents
and polymers is too large a list and the Examiner does not identify any
reason the skilled artisan would have selected the claimed components.
Appeal Br. 23–24. This argument is not persuasive. First, Wakamatsu is not
the only reference of record that discloses NSAIDs, and flurbiprofen in
particular, as suitable drugs for transdermal patches. Kanios (at 8:64–9:6),
Fleischer (¶ 58), Miranda (at 13:4–22), and Sharma (¶ 69) disclose the same;
thus, the record supports that transdermal patches with such an active agent
were well known. Moreover, Wakamatsu expressly claims such an active
agent. Wakamatsu, claim 6. Regarding the claimed polymer matrix,
Wakamatsu discloses the claimed SIS block copolymer, acrylic, and silicone
materials in a list of about 12 options (and suggests their combination),
which we do not find to be so excessive that the combination of these three
would be non-obvious (particularly where other cited prior art, e.g.,
Fleischer ¶ 53 and Miranda passim, identify acrylic and silicone polymers as
well-known matrix materials used in combination). The fact that
Wakamatsu does not disclose an example including the claimed polymers is
not determinative. In re Mills, 470 F.2d 649, 651 (CCPA 1972) (“[A]
reference is not limited to the disclosure of specific working examples.”).
Regarding dependent claims 10–14, Appellant argues that their
specific claimed ranges of polymers would not be obvious because
Wakamatsu discloses higher amounts and there would have been no reason
to combine the teachings of Wakamatsu and Miranda, and also argues that
the cited prior art does not teach effective delivery of NSAID over 8, 12, or
24 hours. These arguments are not persuasive. We find the Examiner’s
Appeal 2020-001010
Application 14/141,946

19
combination of Wakamatsu, Kanios, and Miranda, as discussed above,
teaches the drug and combined polymer components of the claimed system’s
matrix and backing and provides ample support for varying the amounts of
such components to achieve desired results of varying drug delivery rate and
duration. The prior art teaches that these are result effective variables that
can be and would have been optimized by the skilled artisan.
For the reasons set forth above, we conclude that the Examiner did not
err in determining that the claims would have been obvious over the cited
prior art to one of ordinary skill in the art. Appellant’s arguments and
evidence do not persuade us otherwise. We affirm the Examiner’s
obviousness rejections.
OBVIOUSNESS-TYPE DOUBLE PATENTING
Examiner rejects the claims over claims 1–4 and 6–31 of Kanios ’281
“in view of Kanios . . . and Fleischer,” which have been discussed above.
Final Action 21. The Examiner states:
Although the claims at issue are not identical, they are not
patentably distinct from each other because the copending
application recites: A method for selectively controlling
transdermal drug permeation rate from a transdermal drug
delivery system which comprises (a) a pressure sensitive
adhesive (b) a therapeutically effective amount of at least one
drug for transdermal and (c) an occlusive backing layer. The
pressure sensitive adhesive includes a polysiloxane polymer and
at least one acrylic-based polymer; the rubber based adhesive
may also be styrene-isoprene-styrene block copolymers (claims
16 and 18-23).
Id. The Examiner determines that Kanios’s teachings, combined with the
Kanios ’281 claimed subject matter, made the claimed backing layer and its
coated fabric obvious. Id. Further, the Examiner determines that Fleischer’s
Appeal 2020-001010
Application 14/141,946

20
teachings, combined with the Kanios ’281 claimed subject matter, made the
claimed backing coating material obvious. Id.
In response, Appellant restates its arguments regarding the
Examiner’s claim interpretation, which we find unpersuasive, as discussed
above. Appeal Br. 28–29. Appellant further argues that the claimed subject
matter of Kanios ’281 is different from the presently claimed invention
because Kanios ’281 does not claim a fabric backing material or a rubber-
based polymer, i.e., PIB or SIS. Id. at 29. Rather, the Appellant points out
that Kanios ’281 requires a backing layer formed of a plurality of layers,
which are composed of materials different from the presently claimed
occlusive coating materials. Id. We are persuaded by this argument.
As we note above, obviousness-type double patenting is intended as a
tool to prevent an inventor from improperly securing a second, later-expiring
patent for the same or non-obvious variant of an invention claimed in an
earlier, commonly-owned patent. AbbVie, 764 F.3d at 1373. We do not find
this to be the circumstance here. Kanios ’281 claims a specific occlusive
backing, which “comprises a first layer formed from a material selected
from the group consisting of acrylonitrile, cellulose acetate, polycarbonate,
ethylene vinyl acetate, ethylene methyl acrylate, polyester, polyethylene,
polypropylene, polystyrene, polyurethane, polyvinyl alcohol, ethylene vinyl
alcohol, polyamides, polyvinylidene chloride and polyvinyl chloride” and,
optionally, “comprises a second layer formed from a material selected from
the group consisting of cellulose acetate, nylon, polycarbonate, acrylonitrile,
polystyrene, polyurethane and polyvinyl alcohol, or copolymers or
multipolymers of these plastics with additional monomers.” Kanios ’281,
Appeal 2020-001010
Application 14/141,946

21
40:1–7 (claim 1), 41:26–31 (claim 13, which depends from claim 1).
Although other Kanios ’281 claims, e.g., claim 16, recite materials such as
PIB and SIS as a rubber adhesive provided with the system (not part of the
occlusive backing), we find the claims of Kanios ’281 and those on appeal
are directed to different devices composed of different structures and
materials so as to render the later non-obvious over the former.
For the reasons above, we reverse the outstanding obviousness-type
double patenting rejection.
CONCLUSION
In summary:

Claims
Rejected
35
U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–6, 17,
19–24 103(a)
Wakamatsu, Kanios,
Fleischer
1, 3–6, 17,
19–24
1, 3–14, 17,
19–24 103(a)
Wakamatsu, Kanios,
Fleischer, Miranda
1, 3–14,
17, 19–24
1, 3–6, 17,
20–25 103(a)
Wakamatsu, Kanios,
Sharma, Hsu
1, 3–6, 17,
20–25
1, 3–14, 17,
19–24
Nonstatutory Double
Patenting
1, 3–14,
17, 19–24
Overall
Outcome
1, 3–14,
17, 19–25

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)(1)(iv).

AFFIRMED