Parminder Singh et al.

Patent Trials and Appeals Board

May 19, 2020

2019001674 (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.
14/746,758 06/22/2015 Parminder Singh 091500-0550/8008.US20 7850
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 PARMINDER SINGH, ADRIAN FAASSE,
GARY W. CLEARY, SRI MUDUMBA,
MIKHAIL M. FELDSTEIN, and DANIR F. BAYRAMOV
____________

Appeal 2019-001674
Application 14/746,758
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 27 and 30–56 (Appeal Br. 1).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 “A.V.
Topchiev Institute of Petrochemical Synthesis, Russian Academy of
Sciences and Corium International, Inc.” (Appellant’s May 21, 2018 Appeal
Brief (Appeal Br.) 1).
2 This Appeal is related to Appeal 2019-001618, Application 14/246,983 (cf.
Appeal Br. 1).
Appeal 2019-001674
Application 14/746,758
2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to hydrogel compositions useful as
wound dressings and for administering a wide variety of active agents to
mucosal tissue such as the mouth, including tooth whiteners” (Spec. ¶ 2).
Appellant’s independent claims 27 and 56 are reproduced below:
27. A method for preparing a system, the method comprising:
(i) providing a hydrogel comprising a water-swellable,
water-insoluble polymer, a blend of a hydrophilic polymer and
a complementary oligomer capable of hydrogen bonding or
electrostatic bonding to the hydrophilic polymer, and
(ii) depositing the hydrogel on an erodible backing
member comprised of a polymeric component that erodes in a
moist environment of a mucosal body surface at a slower rate
than the hydrogel;
wherein the system comprises an active agent in the
hydrogel either by (i) incorporating the active agent with the
water-swellable, water-insoluble polymer and the blend or (ii)
loading the active agent onto the hydrogel after said depositing
step.
(Appeal Br. 8.)
56. A method for preparing a system, the method comprising:
(i) providing a hydrogel comprising a water-swellable,
water-insoluble polymer, a blend of a hydrophilic polymer and
a complementary oligomer capable of hydrogen bonding or
electrostatic bonding to the hydrophilic polymer, and
(ii) depositing the hydrogel on an erodible backing
member comprised of a polymeric composition that erodes in a
moist environment of a mucosal body surface at a slower rate
than the hydrogel, wherein the polymer composition comprises
a polymer is selected from the group consisting of acrylate
polymers, cellulose derived polymers, cellulose esters, starches,
alginic acid, alginates, polyamino acids, and blends thereof;
wherein the system comprises an active agent in the
hydrogel either by (i) incorporating the active agent with the
Appeal 2019-001674
Application 14/746,758
3
water-swellable, water-insoluble polymer and the blend or (ii)
loading the active agent onto the hydrogel after said depositing
step.
(Id. at 11.)
Grounds of rejection before this Panel for review:
Claims 27, 30–46, 49–51, and 53–56 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Biegajski3 and
Sanvordeker.4
Claims 47 and 48 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Biegajski, Sanvordeker, and
Polymethacrylates.5
Claim 52 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Biegajski, Sanvordeker, and Chalykh.6
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Examiner finds that Biegajski discloses Appellant’s claimed
invention, but for a “hydrogel comprising water swellable polymer and
blend of hydrophilic polymers as . . . [required by Appellant’s independent
claims] 27 and 56” and relies on Sanvordeker to make up for this deficiency

3 Biegajski et al., US 5,700,478, issued Dec. 23, 1997.
4 Sanvordeker et al., US 4,900,552, issued Feb. 13, 1990.
5 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.
6 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).
Appeal 2019-001674
Application 14/746,758
4
in Biegajski (Final Act.7 5). In this regard, Examiner finds that Sanvordeker
discloses a dosage form comprising a “hydratable mucoadhesive layer [that]
is [a] hydrogel, and comprises cellulose acetate butyrate, polyacrylic acid
polymer and PVP” (id.). Thus, based on the combination of Biegajski and
Sanvordeker, Examiner concludes that, at the time Appellant’s invention
was made, it would have been prima facie obvious
to make a device for application to mucosa comprising drug
containing layer comprising blend of hydrophilic polymers and
a layer that erodes slower than the drug containing layer as
taught by Biegajski, and add water swellable cellulose or
polyacrylic polymers taught by Sanvordeker to the drug
containing layer to form hydrogel.
(Id.) We are not persuaded.
Contrary to Examiner’s finding, Sanvordeker does not disclose a
mucoadhesive layer that comprises a hydrogel (see Sanvordeker 1: 46–47
(Sanvordeker discloses that “[t]he mucoadhesive base layer comprises a
hydratable mucoadhesive polymeric matrix” (emphasis added)); cf. id. at ll.
47–49 (Sanvordeker discloses that its “reservoir layer includes a plasticized
film-forming cellulose ester, a dehydrated hydrogel and an active
ingredient”) (emphasis added)). As Appellant explains:
Sanvordeker discloses a trilaminate film comprising a water-
impermeable barrier layer sandwiched between a mucoadhesive
base layer and non-adhesive reservoir layer, wherein the barrier
layer is bonded to mucoadhesive base layer. Sanvordeker, col.
2, lines 14-18. Sanvordeker discloses that the non-adhesive
reservoir layer NOT the mucoadhesive layer is constituted by a
plasticized film-forming cellulose ester and a dehydrated
hydrogel. Sanvordeker, col. 3, lines 46-48. Sanvordeker
further discloses that the water-impermeable barrier inhibits the
diffusion of the active ingredient to the base layer. Id., col. 5,

7 Examiner’s November 20, 2017 Final Office Action.
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Application 14/746,758
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lines 48-50. Sanvordeker further discloses that the water-
impermeable barrier inhibits the diffusion of the active
ingredient to the base layer. In other words, Sanvordeker does
not teach that “such ingredients are capable of delivering active
agent to the buccal cavity while attaching to the wall of the
cavity” as contended by the Office because no active agent in
the dehydrated hydrogel containing non-adhesive layer is
delivered to the buccal cavity through base layer.
(Appeal Br. 6; see also Reply Br. 4.)
We find that Examiner’s assertion that Sanvordeker’s mucoadhesive
layer may comprise an active agent misses the point of Appellant’s
contentions (see Ans. 7–8 (citing Sanvordeker 3: 44–45)). As Appellant
explains, although “Sanvordeker . . . discloses one type of material[] suitable
for forming the hydratable mucoadhesive base layer is water-swellable
polymers . . . nowhere does Sanvordeker disclose the water-swellable
polymers in a hydrogel composition” (Reply Br. 4 (citing Sanvordeker 2:
65–67)). Thus, because Sanvordecker’s mucoadhesive does not comprise a
hydrogel, the issue is whether it would have been prima facie obvious to
incorporate components, i.e. a hydrogel, of Sanvordecker’s non-adhesive
reservoir layer into Biegajski’s mucoadhesive layer. Examiner failed to
address this issue. Thus, we find that the evidence of record supports
Appellant’s contention that “a skilled artisan would not be motivated to
incorporate Sanvordeker’s teachings about a non-adhesive layer into
Biegajski’s basal adhesive layer so as to arrive at . . . [Appellant’s] claims”
(Appeal Br. 6; see also Reply Br. 4).
Examiner failed to establish an evidentiary basis on this record to
establish that Polymethacrylates, as applied to claims 47 and 48, or Chalykh,
as applied to claim 52, make up for the foregoing deficiency in the
combination of Biegajski and Sanvordeker (see Final Act. 8–10; cf. Appeal
Appeal 2019-001674
Application 14/746,758
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Br. 7 (Appellant contends that “Polymethacrylates and Chalykh . . . do not
cure the deficiencies of Biegajski and Sanvordeker)).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 27, 30–46, 49–51, and 53–56 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Biegajski and Sanvordeker
is reversed.
The rejection of claims 47 and 48 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Biegajski, Sanvordeker, and
Polymethacrylates is reversed.
The rejection of claim 52 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Biegajski, Sanvordeker, and Chalykh is reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
27, 30–46, 49–
51, 53-56
103 Biegajski,
Sanvordeker
27, 30–46,
49–51, 53-
56
47, 48 103 Biegajski,
Sanvordeker,
Polymethacrylates
47, 48
52 103 Biegajski,
Sanvordeker,
Chalykh
52
Overall
Outcome
27, 30–56

REVERSED