Kang-Mieler, Jennifer J.

Patent Trials and Appeals Board

Oct 19, 2020

2020000803 (P.T.A.B. Oct. 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.
15/273,098 09/22/2016 Jennifer J. Kang-Mieler JKM-101 9176
42419 7590 10/19/2020
PAULEY ERICKSON & SWANSON
2800 WEST HIGGINS ROAD
SUITE 365
HOFFMAN ESTATES, IL 60169
EXAMINER
ALLEY, GENEVIEVE S
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
10/19/2020 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JENNIFER J. KANG-MIELER, ERIC BREY,
VICTOR PEREZ-LUNA, BIN JIANG, and CHRISTIAN OSSWALD

Appeal 2020-000803
Application 15/273,098
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and
JASON V. MORGAN, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected claims 10, 12–21, 25, 26, and 33–39 under 35
U.S.C. § 103 as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals
from the Examiner’s decision to reject the claims. 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 Dr. Jennifer J.
Kang-Mieler. Appeal Br. 2.
Appeal 2020-000803
Application 15/273,098

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STATEMENT OF THE CASE
The Examiner rejected the claims as follows:
Claims 10, 12–15, 17–21, 25, 26, 33–35, and 37–39 under 35 U.S.C.
§ 103 as obvious in view of Shih et al. (US 6,287,588 B1; published Sept.
11, 2001) (“Shih”), Robledo (US 2014/0242176 A1, published Aug. 28,
2014) (“Robledo”), and Einmahl et al. (A Novel Route of Ocular Drug
Delivery: Suprachoroidal Injections of a Sustained Release System, Proceed.
Int’l Symp. Rel. Bioact. Mater., 2001, 28: 293–294) (“Einmahl”). Final Act.
5.
Claims 16 and 36 under 35 U.S.C. § 103 as obvious in view of Shih,
Robledo, Einmahl, and Brey et al. (US 2014/0065226 A1, published: Mar.
6, 2014) (“Brey”). Final Act. 10–11.
Independent claim 10 is representative. Claim 10 is reproduced below:
10. A method of delivering a compound to an eye, the
method
applying to or into an eye of a mammal a composition in
a first physicochemical state, wherein the composition
comprises a treatment agent microencapsulated in degradable
microcapsules suspended in a degradable thermoresponsive
hydrogel, wherein the degradable microcapsules comprise
polyethylene glycol (PEG), Mg(OH)2, bovine serum albumin,
and sucrose; and
the composition changing to a second physicochemical
state upon administration, wherein the second physicochemical
state is more solid than the first physicochemical state, wherein
the degradable microcapsules release the microencapsulated
treatment agent over time after applying.

OBVIOUSNESS REJECTIONS
The claim is directed to a method comprising applying a composition
to or into an eye of a mammal. The composition comprises “a treatment
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agent microencapsulated in degradable microcapsules suspended in a
degradable thermoresponsive hydrogel.” The microcapsules comprise PEG,
Mg(OH)2 (magnesium hydroxide), bovine serum albumin (BSA), and
sucrose. Jennifer Kang-Mieler, Ph.D., a co-inventor of the application states
in a declaration under 37 C.F.R § 1.132 (“Kang-Mieler Decl.”) that
microcapsules, having these four components, when suspended in the
claimed hydrogel, had “a significantly longer controlled release of treatment
agents compared to the known prior art.” Kang-Mieler Decl. ¶ 3.
The Examiner found that Shih describes a composition that can be
administered to the eye which comprises microparticles in a gel as required
by rejected claim 10. Final Act. 6. The Examiner found that the
microparticles can comprise a polyol sugar, but not the polyol sugar sucrose
which is recited in the claim. Final Act. 8. The Examiner found, however,
that Robledo describes utilizing sucrose as an isotonizer in an eye drop
formulation. Final Act. 9. The Examiner also found that Robledo describes
microspheres made of BSA and PEG, two other components of the claimed
degradable microcapsule. Final Act. 10. With respect to the inclusion of
Mg(OH)2 in the microcapsule, the fourth component in the microcapsule, the
Examiner found that Einmahl teaches that Mg(OH)2 is used as a stabilizer in
a POE (poly(ortho ester)) degradable system for drug delivery to the eye,
making it obvious to include it in the microcapsule suggested by Shih and
Robledo. Final Act 9, 10.
Appellant argues that Robledo discloses that a sugar, such as sucrose,
is used as the liquid carrier of eye drops, and not in forming a
microencapsulation structure as required by the claims. Appeal Br. 7.
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Appellant also argues that the sugars disclosed in Shih are used in the
hydrogel phase, and not for building the microcapsules. Id. at 8.
Appellant states that the Mg(OH)2 used in Einmahl is present in an
injectable composition and is not part of the microcapsule as required by all
the rejected claims. Id. at 9.
We agree with Appellant that the Examiner erred2 in finding that
sucrose and Mg(OH)2 are described as part of a microcapsule in the cited
prior art publications and that it would have been obvious to one of ordinary
skill in the art to have included these components in a microcapsule with
PEG and BSA.
As found by the Examiner, Shih describes “a biocompatible polymeric
gel containing microparticles which release a desired bio-active agent into a
biological environment.” Shih 3: 39–41. The Examiner considered Shih’s
“microparticles” to correspond to the claimed “microcapsules.” Shih
therefore teaches the same type of system that is claimed, i.e., “a treatment
agent microencapsulated in degradable microcapsules suspended in a
degradable thermoresponsive hydrogel.” The gel described in Shih can also
be thermoresponsive as required by the rejected claims (Shih 6: 42–44; “The
use of temperature sensitive biocompatible polymers as the gel matrix is a
preferred embodiment of the present invention.”), where temperature

2 We review appealed rejections for reversible error based on the arguments
and evidence the Patent Owners provide for each issue the Patent Owners
identify. 37 C.F.R. § 41.37(c)(1)(iv); Ex parte Frye, 94 USPQ2d 1072,
1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had
failed to make a prima facie case, “it has long been the Board’s practice to
require an applicant to identify the alleged error in the examiner’s
rejections”)).

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determines whether the polymer is a liquid or gel (Shih 4: 44–47;
“‘Thermosensitive polymeric gel’ shall mean any polymeric gel that,
depending on temperature, may exist in liquid state or a gel state.”).
The Examiner relied on the following passage from Shih as disclosing
a polyol sugar in its microparticle:
Additives, such as polyols (including sugars), amino acids,
surfactants, polymers, other proteins and certain salts may be
used. These additives can readily be incorporated into the
microparticle/polymer gel system of the present invention,
which will then undergo a gelation process.
Shih 10: 51–56.
The additives described by Shih, which includes polyols, are
incorporated into the system and then undergo gelation. Id. Shih describes
“gelation” as a property of the gel system. For example:
“Gel” means the semi-solid phase that spontaneously
occurs as the condition for the gelation of the polymer or
copolymer is met.
“Polymeric gel” shall mean any polymer, copolymer,
block copolymer and the like that exhibits gelation properties
for a period of time when administered within a biological
environment, but may be a liquid under conditions not present
in that environment.
Shih 4: 36–43 (emphasis added).
Thus, the disclosure in Shih that the additives are present in a system
that undergoes “gelation” indicates that they are present in the gel. The
Examiner did not establish that there is a teaching in Shih that a polyol is
present in the microparticles (“microcapsules”) as required by all the
rejected claims in this appeal. The Examiner also did not explain how this
teaching by Shih of a polyol in the gel would have provided a reason to
place the polyol in the microparticle/microcapsule instead.
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The Examiner also relied on Robledo for disclosing the presence of
sucrose in the microcapsule. Robledo describes microspheres (Robledo
¶ 11), which the Examiner found to correspond to the claimed
microcapsules. The Examiner cited the following passage from Robledo for
this teaching:
In addition to a buffer, isotonizers can be added to eye drops to
make the preparation isotonic with the tear. Isotinizers [sp]
include, but are not limited to, sugars such as glucose, sucrose
. . . Isotonizers are added in an amount that makes the osmotic
pressure of the eye drop equal to that of the tear.
Robledo ¶ 46.
Robledo discloses that the sucrose is in the eye drop, but does not
teach its presence in the microsphere. See also claim 10 of Robledo where
the isotonic agent (“isotonizer”) is claimed as being present in a solution
(“The composition of claim 1, wherein said carrier suitable for ophthalmic
application is a solution comprising an isotonic agent”). Robledo describes
the microspheres in a separate section, beginning at paragraph 52 of its
disclosure. The Examiner did not identify the presence of sucrose or an
isotonizer in this section of Robledo which describes the microspheres. The
Examiner did not explain how the presence of sucrose in an eye drop
solution provides a reason to use it in the microsphere of Robledo.
We are also not persuaded that one of ordinary skill in the art would
have had reason to use Mg(OH)2 as stabilizer for the claimed microcapsule.
The Examiner did not establish that the teaching by Einmahl that Mg(OH)2
is a “stabilizing excipient” for an injected POE polymer composition
provides a reasonable expectation of success that it would serve as a
stabilizer for a different composition, comprising a PEG polymer, in a
microcapsule comprising PEG, BSA, and sucrose. To establish obviousness,
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there must be a reasonable expectation of success. In re Merck & Co., Inc.,
800 F.2d 1091 (Fed. Cir. 1986).
“An examiner bears the initial burden of presenting a prima facie case
of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). Because this burden was not met, we are compelled to reverse the
rejection of claim 10. The rejections of dependent claims 12–20 and 33 are
reversed for the same reasons. Independent claims 34 and 39, and dependent
claims 34–38, comprise the same components as the microparticle of claim
10; the rejections of these claims are reversed as well.
DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C. §
References Affirmed Reversed
10, 12–15,
17–21, 25,
26, 33–35,
37–39
103 Shih, Robledo,
Einmahl
10, 12–15,
17–21, 25,
26, 33–35,
37–39
16, 36 103 Shih, Robledo,
Einmahl, Brey
16, 36
Overall
Outcome
10, 12–21,
25, 26, 33–
39

REVERSED