Gary W. Cleary et al.

Patent Trials and Appeals Board

May 19, 2020

2019001618 (P.T.A.B. May. 19, 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.
14/264,983 04/29/2014 Gary W. Cleary 091500-0517/8008.US17 6796
108547 7590 05/19/2020
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
05/19/2020 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):
mweipdocket@mwe.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GARY W. CLEARY, SHOREH PARANDOOSH,
MIKHAIL M. FELDSTEIN, ANATOLY E. CHALYKH,
NICOLAI A. PLATÈ, and VALERY G. KULICHIKHIN
____________

Appeal 2019-001618
Application 14/264,983
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
DEBORAH KATZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 84–91 and 93–101 (Appeal Br. 2).2 We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Corium
International, Inc. and A.V. Topchiev Institute of Petrochemical Synthesis,
Russian Academy of Sciences” (Appellant’s July 3, 2018 Appeal Brief
(Appeal Br.) 1).
2 This Appeal is related to Appeal 2019-001674, Application 14/746,758
(see Appeal Br. 1).
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STATEMENT OF THE CASE
Appellant’s disclosure relates “to hydrogel composition” (Spec.3 ¶ 2).
Claim 84 is reproduced below:
84. A delivery system for topical administration of a locally
active agent to the skin, the system comprising:
a body-surface contacting layer comprised of an adhesive
hydrogel composition positioned on a backing layer, the
adhesive hydrogel composition comprising:
(i) a water-swellable, water-insoluble polymer in an
amount ranging from about 2 weight percent to about 15 weight
percent of the hydrogel composition, wherein said polymer is
insoluble in water within a selected pH range and is an acrylate
copolymer comprising monomers selected from the group
consisting of acrylic acid, methacrylic acid, methyl acrylate,
ethyl acrylate, methyl methacrylate, and ethyl methacrylate, and
wherein the acrylate copolymer has a ratio of free carboxyl
groups to ester groups in a range of about 1:1 to 1:2;
(ii) a blend of a hydrophilic polymer and a
complementary oligomer, where the hydrophilic polymer is a
poly(N-vinyl lactam), the complementary oligomer is a low
molecular weight polyalkylene glycol having a molecular
weight of 300 to 600 daltons, and the hydrophilic polymer
represents about 75 weight percent to about 25 weight percent
of the hydrophilic polymer-complementary oligomer blend,
(iii) a permeation enhancer, and
(iv) a locally active agent.
(Appeal Br. 14.)

3 Appellant’s April 29, 2014 Specification.
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Claims 84–91 and 93–101 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Murray,4 Chalykh,5 Roreger,6
Sanvordeker,7 Kolter,8 and Polymethacrylate.9, 10

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Murray discloses
a hydrogel-forming wound dressing or skin coating material
consisting substantially entirely of wound-compatible and skin-
compatible ingredients and comprising a first hydrophilic
polymer, selected from[, inter alia,] polymers and copolymers
of acrylic acid, polymers or copolymers of methacrylic acid, . . .
or combinations thereof; a second hydrophilic polymer which is
capable of interacting with the first polymer to produce, upon
drying, a hydrogel of improved water resistance and film-
forming properties relative to the first hydrophilic polymer

4 Murray et al., US 4,920,158, issued Apr. 24, 1990.
5 Chalykh et al., Effects of Composition and Hydration on Adhesive
Properties of Poly(N-Vinyl Pyrrolidone)-Poly(Ethylene Glycol) Hydrogels,
81 Polym. Mater. Sci. Eng. 456–457 (1999).
6 Roreger et al., US 5,456,745, issued Oct. 10, 1995.
7 Sanvordeker et al., US 4,900,552, issued Feb. 13, 1990.
8 Kolter et al., WO 98/05360, published Feb. 12, 1998.
9 Chang et al., Polymethacrylates, Handbook of Pharmaceutical Excipients,
401–406 (3rd ed., Arther H. Kibbe, ed., 2000). Appellant and Examiner refer
to this document as “Polymethacrylate,” therefore we do the same.
10 The obviousness-type double patenting rejections and provisional
rejection on this record are moot, in view of the terminal disclaimers
submitted by Appellant, and will not be discussed further (see Examiner’s
January 3, 2018 Final Office Action (Final Act.) 2–8; see also Examiner’s
October 17, 2018 Answer (Ans.) 3).
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alone; and water, the material being film-forming and
substantially transparent or translucent although capable of
being made opaque.
(Murray 3:46–62; see Final Act. 10).
FF 2. Murray discloses that its second hydrophilic polymer are “selected
from polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP),[11]
polyethylene oxide (PEO), copolymer combinations of propylene oxide and
ethylene oxide [P(EO/PO)], and gelatin” (Murray 4:63–66; see Final Act. 10
(alteration original); see also Final Act. 10–11 (Examiner finds that
polyethylene glycol (PEG) is a PEO)).
FF 3. Murray discloses that “[i]t is preferred although not strictly
necessary in all embodiments, that at least one suitable plasticizer be added
to the hydrogel-forming material,” wherein “[p]referred plasticizers for use
in this invention are[, inter alia,] propylene glycol” (Murray 5:9–11 and 6:3–
4; see Final Act. 1012).
FF 4. Murray discloses:
Due to the permeability and biological inertness of the
hydrogel-forming material, the novel materials of this invention
are particularly suited for the incorporation therein of a wide
variety of chemotherapeutic agents, medicinal agents and
additives. For instance, the dressing can contain topical
keratolytics such as salicylic acid and the like, or agents which

11 Appellant discloses that PVP is a poly(N-vinyl lactam) within the scope of
Appellant’s claimed invention (see Spec. ¶ 73; cf. Appeal Br. 14).
12 Although Examiner correctly finds that Murray discloses that a plasticizer,
“such as propylene glycol,” may be added to Murray’s hydrogel material,
Examiner incorrectly finds that Murray discloses that its plasticizer may be
“polypropylene glycol” (see Final Act. 10–11).
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accelerate healing, or agents with antimicrobial or hemostatic
activity.
(Murray 10: 8–15; see Final Act. 10 (Examiner finds that Murray’s
“dressing can contain active agent for delivery from the hydrogel such as
antimicrobial agents”).)
FF 5. Examiner finds that although Murray discloses a “combination of
acrylate polymer, PVP and plasticizer,” Murray does not disclose an
“amount of acrylate polymer in the composition,” “the amount of the
hydrophilic polymer in the combination of hydrophilic polymer and
complementary oligomer,” “acrylate copolymers,” or the “backing layer”
required by Appellant’s claim 84 (see Final Act. 11).
FF 6. Chalykh discloses a PVP-PEG hydrogel pressure sensitive adhesive
(PSA) “prepared by dissolving PVP (Mw = 1,000,000) and PEG 400 in ethyl
alcohol followed by casting the solution on a . . . backing film and drying,”
wherein “[t]he PEG content in the blends varied from 25 to 50 wt %”
(Chalykh 456; see Final Act. 11 (Examiner finds that Chalykh’s “PEG
content in the blend varies from 25-50%, which implies PVP content would
be 75-50%”)).
FF 7. Chalykh discloses that “PEG accounts for the PVP blends’ adhesive
properties, affecting critically the height and position of the peel force
maximum along the axis of PEG and water content” (Chalykh 456; see
generally Final Act. 11).
FF 8. Chalykh discloses that “[a]lthough neither PVP nor PEG per se
demonstrate any pressure sensitive adhesion, their blends exhibit adhesion
and absorbed water can influence adhesive behaviour of the PVP·PEG
hydrogels in a complicated manner,” wherein “[o]nly the blends in very
narrow range of PEG content (in vicinity of 36 wt. %) provide high
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adhesion, whereas both PEG underloaded and overloaded blends reveal no
adhesion, demonstrating that both initial polymers are non-adhesive”
(Chalykh 456; see generally Final Act. 11 (Examiner finds that “[t]he
maximum strength of . . . [Chalykh’s] hydrogel obtained by PEG content of
36%, i.e. PVP content of 64%”)).
FF 9. Roreger discloses:
[A] hydrophilic, flexible gel film which, without the need to use
cross-linking agents, exhibits a mechanical stability in swollen
condition and has a high water absorption capacity, said
stability enabling easy handling, and the gel film being
produced of components having optimum skin and mucous
membrane tolerance, and which may be loaded with active
substance, if needed[, wherein the gel film comprises:]
(a) 0.5 to 30%-wt of at least one water-soluble polymer
being anion-active at neutral pH
(b) 0.5 to 50%-wt of at least one water-soluble polymer
being cation-active at neutral pH
(c) 0.1 to 20%-wt of at least one moisturizer and
(d) 0.1 to 70%-wt of water
[wherein] . . . the gel film may contain,
(e) 0 to 75%-wt of water-soluble or water-dispersible
auxiliaries and
(f) 0 to 50%-wt of active substance
(Roreger 2:11–31; see Final Act. 11 (Examiner finds that “[t]he high water
absorption capacity reads on hydrogel” and the active substance or
“[p]harmaceutical active agents include various substances to treat acne, i.e.
cosmetic agent” (citing Roreger 1:15–23, 7:6–8:20)); see generally Final
Act. 11–12.)
FF 10. Roreger discloses that the water-soluble polymer being anion-active
at neutral pH may be “Eudragit L/S®”, the water-soluble polymers being
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cationic at neutral pH may be “Eudragit E®” or “Eudragit RL/RS®”, and
the moisturizer may be “low molecular [weight] polyethylene glycols”
(Roreger 2:32–67; see Final Act. 11–12; Final Act. 12 (citing Roreger 13–
14:Examples 3, 7 and 12) (Examiner finds that Roreger exemplifies
“Eudragit in an amount of 4%, 10% and 15%”)).
FF 11. Roreger discloses that “[t]he gel film may contain as penetration
accelerator, e.g. alkyl sulphates, alkyl sulphonates, alkali soaps, fatty acid
salts of multivalent metals, betaine, amine oxides, fatty acid esters, mono-,
di- or triglycerides, long-chain alcohols, sulphoxides, nicotinic acid esters,
salicylic acid, N-methylpyrrolidone, 2-pyrrolidone, or urea” (Roreger 4:19–
24; see Final Act. 12).
FF 12. Sanvordeker discloses
A buccal dosage form which is a trilaminate film segment
capable of delivering an active ingredient within the buccal
cavity while attached to a wall of that cavity. The trilaminate
film segment includes a hydratable mucoadhesive base layer, a
non-adhesive reservoir layer and a water-impermeable barrier
sandwiched between and bonded to the base layer and the
reservoir layer.
The mucoadhesive base layer comprises a hydratable
mucoadhesive polymeric matrix. The reservoir layer includes a
plasticized film-forming cellulose ester, a dehydrated hydrogel
and an active ingredient. The water-impermeable barrier film
includes a cellulose ester film.
(Sanvordeker 1:38–51; id. at 3:46–48 (Sanvordeker discloses that “the non-
adhesive reservoir layer is constituted by a plasticized film-forming cellulose
ester and a dehydrated hydrogel); see generally Final Act. 12).
FF 13. Kolter “relates to the use of (Meth) acrylic acid copolymers to
increase the permeability of the Mucosa” (Kolter 1; see generally Final Act.
12).
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FF 14. Examiner finds that Kolter discloses that Kollicoat® MAE 30D, a 1:1
ethyl acrylate/methacrylic acid polymer that is soluble at a pH above 5.5,
enhanced permeation at “a concentration up to 3%” (Final Act 12–13 (citing
Kolter 1 and 6–7; Polymethacrylate 402–404)).
ANALYSIS
Based on the combination of Murray, Chalykh, Roreger, Sanvordeker,
Kolter, and Polymethacrylate, Examiner concludes that, at the time
Appellant’s invention was made, it would have been prima facie obvious
to provide hydrogel composition comprising polymers or
copolymers of acrylic acid or methacrylic acid, PVP that can be
mixed with PEG, and plasticizer as taught by Murray, and use
PVP mixed with PEG as a plasticizer wherein the . . . mixture
of PVP and PEG comprises 36% PEG and 64% PVP as taught
by Chalykh . . . because Chalykh teaches such a mixture
provides adhesive hydrogel having maximum strength and
because PEG is significant potent plasticizer to PVP, and their
plasticizing effect is additive and complement each other.
(Final Act. 13.) With respect to the amount of acrylic and hydrophilic
polymers required by Appellant’s claimed invention, Examiner finds that
“Roreger, Sanvordeker and [Kolter] teach amounts of acrylic polymer
falling within the claimed amount, and Chalykh teach amounts of
hydrophilic polymer falling within the claimed amount” (id. at 14). In this
regard, Examiner reasons that
one having ordinary skill in the art would have been motivated
to use between 0.5-50% and particularly 4%, 10% and 15% of
the acrylic or methacrylic polymers as taught by Roreger, or 3%
or 6% polyacrylic acid taught by Sanvordeker in the hydrogel
composition taught by the combination of Murray and Chalykh
because Roreger teaches gel film comprising such an amount of
acrylate polymer is flexible and exhibits mechanical stability in
swollen condition and has a high water absorption capacity,
handling stability and optimum skin and mucous membrane
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tolerance and because Sanvordeker teaches suitability of such
amount of polyacrylic acid to provide adhesive hydrogel.
(Final Act. 13–14.) According to Examiner, (a) “Sanvordeker is relied upon
for solely teaching polyacrylate in the skin contacting layer in an amount of
3-6%;” (b) “[o]ne having ordinary skill in the art would have used
[Roreger’s] acrylic copolymer . . . instead of [Murray’s] acrylic polymer . . .
based on [the] suitability of both for hydrogel [formulations] suitable for
wound healing;” and (c) “[o]ne having ordinary skill in the art would have
replaced the acrylic polymers of Murray with Kollicoat® MAE 30D taught
by [Kolter] because [Kolter] teaches the effect of such polymer in lowering
transepithelial resistance, hence increase[ing] permeability” (Final Act. 17;
see generally Ans.13 7–16). We are not persuaded.
The evidence of record supports a finding that Murry fails to disclose
an adhesive hydrogel, as required by Appellant’s claimed invention (see
Appeal Br. 14). Examiner relies on Sanvordeker and Chalykh to make up
for this deficiency in Murray (see FF 6–8 and 12). Sanvordeker’s
mucoadhesive, however, does not comprise a hydrogel (see Appeal Br. 6).
To the contrary, Sanvordeker discloses that “the non-adhesive reservoir
layer,” not the mucoadhesive layer, of its trilaminate (mucoadhesive base
layer, non-adhesive reservoir layer, and water-impermeable barrier) film
comprises “a dehydrated hydrogel” (FF 12; see also Appeal Br. 6).
Chalykh, as relied upon by Examiner, also fails to support a
conclusion of obviousness. The adhesive hydrogel composition of
Appellant’s claimed invention, comprises four components: (i) an acrylate
copolymer, (ii) a blend of a hydrophilic polymer and a complementary

13 Examiner’s October 17, 2018 Answer.
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oligomer, (iii) a permeation enhancer, and (iv) a locally active agent (see
Appeal Br. 14). Chalykh, however, describes a hydrogel composition
comprising PVP and PEG, which according to Examiner corresponds to the
hydrophilic polymer and complementary oligomer, respectively, of
component (ii) of Appellant’s claimed invention (see Final Act. 11; see also
FF 6–8). In this regard, Chalykh discloses that “PEG accounts for the PVP
blend’s adhesive properties” and “[o]nly the blends in very narrow range of
PEG content (in vicinity of 36 wt. %) provide high adhesion, whereas both
PEG underloaded or overloaded blends reveal no adhesion” (FF 7–8).
Examiner failed to adequately explain how the evidence on this record
supports a conclusion that a person of ordinary skill in this art would have
reasonably expected that Chalykh’s, PEG concentration sensitive, PVP-PEG
hydrogel composition to retain its pressure sensitive adhesive properties
when combined with the other three components of Appellant’s claimed
adhesive hydrogel composition. See In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.”). In this regard, we note that in order “to have a reasonable
expectation of success, one must be motivated to do more than merely to
vary all parameters or try each of numerous possible choices until one
possibly arrived at a successful result.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1365 (Fed. Cir. 2007) (quoting Medichem, S.A. v. Rolabo, S.L., 437
F.3d 1157, 1165 (Fed. Cir. 2006)).
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Examiner further failed to establish that any of Roreger, Kolter, or
Polymethacrylate alone or in combination make up for the foregoing
deficiencies in the combination of Murray, Chalykh, and Sanvordeker.
Having found that Examiner failed to establish an evidentiary basis on
this record to support a conclusion of obviousness, we do not address
Appellant’s evidence of unexpected results presented to rebut a prima facie
case of obviousness (see Appeal Br. 10–13).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 84–91 and 93–
101 under 35 U.S.C. § 103(a) as unpatentable over the combination of
Murray, Chalykh, Roreger, Sanvordeker, Kolter, and Polymethacrylate is
reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
84–91,
93–101
103 Murray, Chalykh,
Roreger,
Sanvordeker,
Kolter,
Polymethacrylate
84–91,
93–101

REVERSED