DSM IP ASSETS B.V.

Patent Trials and Appeals Board

Nov 8, 2021

2020005222 (P.T.A.B. Nov. 8, 2021)

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.
15/301,473 10/03/2016 Jens Christoph THIES 29314-us-pct 1300
109143 7590 11/08/2021
DSM North America Inc.
Patent Department
6480 Dobbin Road
Columbia, MD 21045
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
11/08/2021 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):
dsm_PAIR@firsttofile.com
dsmna.ip@dsm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JENS CHRISTOPH THIES,
DETLEF OLAF ALEXANDER SCHUMANN, GEORGE MIHOV,
and JULIEN FRANCOIS BERARD
Appeal 2020-005222
Application 15/301,473
Technology Center 1600
Before ULRIKE W. JENKS, RACHEL H. TOWNSEND, and
MICHAEL A. VALEK, Administrative Patent Judges.

JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision2 to reject claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as DSM IP Assets
B.V. Appeal Br. 2.
2 We have considered, and herein refer to, the Specification of October 3,
2016 (“Spec.”); Final Office Action of September 19, 2019 (“Final Act.”);
Appeal 2020-005222
Application 15/301,473
2
BACKGROUND
According to the Specification, long term controlled release
corticosteroid formulations are known to have a disadvantage of releasing an
acid by product.
[L]ong-term controlled or sustained release formulation of a
Class B corticosteroid comprising a lactic acid-glycolic acid
copolymer [PLGA] micro-particles used for the treatment of
osteoarthritis, rheumatoid arthritis, acute gouty arthritis or
synovitis [is known in the prior art]. Disadvantage of this
formulation is however that lactic acid-glycolic acid
copolymers degrade hydrolytically whereby acidic byproducts
are released during the polymer degradation.
Spec. 2:33–3:3. Using “a biodegradable polyester-amide [PEA] co-polymer
comprising at least a diol of a bicyclic-1,4:3,6-dianhydrohexitol used for the
treatment of arthritic disorder” overcomes the disadvantage of acid release
associated with PLGA. Id. at 3:16–19. Inclusion of “a diacid, a diol different
from bicyclic-1,4:3,6-dianhydrohexitol and at least two different amino-
acids. These polymers have higher glass transition temperature which is
beneficial for the articles shape stability and formulation injectability . . . [in
addition to providing] a better balance between drug elution and
biodegradation properties.” Id. at 4:18–22.
CLAIMED SUBJECT MATTER
The claims are directed to treating pain by injecting microparticles
comprising an analgesic and one or more polymers into the joints of a

Appeal Brief of February 19, 2020 (“Appeal Br.”); Examiner’s Answer of
May 6, 2020 (“Answer”); and Reply Brief of July 2, 2020 (“Reply Br.”).
Appeal 2020-005222
Application 15/301,473
3
patient having joint pain. Claim 16, reproduced below, is illustrative of the
claimed subject matter:
16. A method of treating pain or inflammation in a human or
veterinary patient comprising administering to said patient
injecting into the knee, hip, or shoulder of a human or
veterinary patient suffering from an arthritic disorder a
therapeutically effective amount of a formulation comprising
microparticles sized for injection, wherein the microparticles
comprise an analgesic and one or more polymers comprising a
biodegradable polyesteramide co-polymer comprising structural
formula (I):

wherein
m is from 0.01 to 0.99; p is from 0.99 to 0.01; and q is from
0.99 to 0.01;
n varies is from 5 to 100;
R1 is independently selected from the group consisting of (C2-
C20)alkylene, (C2-C20)alkenylene and combinations thereof;
R3 and R4 in a single backbone unit m or p, respectively, are
independently selected from the group consisting of
hydrogen, (C1-C6)alkyl, (C2-C6)alkenyl, (C2-C6)alkynyl, (C6-
C10)aryl (C1-C6)alkyl, -(CH2)SH, -(CH2)2S(CH3), -CH2OH, -
CH(OH)CH3, -(CH2)4NH3+, -CH2COOH, -(CH2)COOH, -
CH2-CO-NH2, -CH2CH2-CO-NH2, -CH2CH2COOH, CH3-
CH2-CH(CH3 )-, (CH3)2-CH-CH2-, H2N-(CH2)4-, phenyl-
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CH2-, -CH=CH-CH3, HO-p-phenyl-CH2-, (CH3)2-CH-,
phenyl-NH-, NH2-(CH2)3-CH2- or NH2-CH=N-CH=C-CH2-;
R5 is (C2-C20) alkylene or (C2-C20) alkenylene;
R6 is selected from bicyclic-fragments of 1,4:3,6-
dianhydrohexitols of structural formula (II);

R7 is hydrogen, (C6-C10) aryl, (C1-C6) alkyl or a protecting group; and
R8 is independently (C1-C20) alkylene or (C2-C20)alkenyl;
wherein the release rate of the analgesic correlates with the local
level of inflammation of the patient, and wherein the release of the
analgesic continues for from two to six months in vivo.
Appeal Br. 22–23 (Claims Appendix) (emphasis added). Claim 25, the only
other independent claim, recites: “wherein the release rate of the analgesic
from the microparticle correlates with the presence of HL60 neutrophil-like
cell lysate, and wherein the release of the analgesic continues for from two
to twelve months in vivo.” Id. at 25.
REFERENCES
The prior art relied upon by Examiner is:
Name Reference Date
Bodick et al. US 2012/0282298 Al Nov. 8, 2012
Franken et al. WO 2012/150255 Al Nov. 8, 2012
Alfonso Rodriguez-
Galan et al.
Degradable Poly(ester amide)s
for Biomedical Applications, 3
Polymers 65–99
2011
Martina Kropp et al. Biocompatibility of Poly(ester
amide) (PEA) Microfibrils in
Ocular Tissues, 6 Polymers
243–260
2014
Appeal 2020-005222
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REJECTION
Appellant requests review of Examiner’s rejection of claims 16, 18,
19, 25–27, 29, 30, 32–37, and 39–42 under 35 U.S.C. § 103 over Bodick in
view of Franken, Kropp, and Rodriguez-Galan.
OPINION
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that the claimed pain treatment method is obvious
over the cited art.
A. Findings of Fact
FF1. Bodick teaches “[c]orticosteroid microparticle formulations are
provided for use for treating pain, including pain caused by
inflammatory diseases such as osteoarthritis or rheumatoid arthritis
. . . . Corticosteroid microparticle formulations are administered
locally as a sustained release dosage form (with or without an
immediate release component).” Bodick, Abstract; see Ans. 4. “[A]
microparticle matrix (such as PLGA, PLA, hydrogels, hyaluronic
acid, etc.) incorporates a corticosteroid, and the corticosteroid
microparticle formulation provides at least two weeks, preferably at
least three weeks, including up to and beyond 30 days, or 60 days, or
90 days of a sustained, steady state release of the corticosteroid.”
Bodick ¶ 9; see Ans. 4.
FF2. Bodick teaches incorporation of corticosteroid salt or esters of
betamethasone, dexamethasone, and triamcinolone acetonide among
others. Bodick ¶ 80. Bodick also teaches administering combinations
of corticosteroids. Id.
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FF3. Bodick teaches the incorporation of triamcinolone acetonide (TCA)
into PLGA microparticles. Bodick ¶¶ 228–233 (Example 4). TCA
incorporation was 24%, and particle size ranges from 32–73 µm. Id.
¶ 230. Bodick teaches that the microparticle size should be from
10–100 µm in order to be delivered through a 19 gauge needle. See id.
¶ 225.
FF4. Bodick teaches that “treatment” and “treating” is understood as
“includ[ing] partial alleviation of symptoms as well as complete
alleviation of the symptoms for a time period. The time period can be
hours, days, months, or even years.” Bodick ¶ 175.
FF5. Bodick teaches that “[w]hen the composition is administered intra-
articularly (e.g., by one or more injections), a therapeutically effective
amount of corticosteroid(s) is released for a period of time.” Bodick
¶ 80, see also id. ¶ 222 (“To inject the microparticles into a joint,
needles having a gauge of about 14-28 gauge are suitable.”), see id.
¶ 151 (teaching intra-articular administration into the knee); see Ans.
4–5.
FF6. Kropp teaches that there is one FDA approved poly(lactic-co-glycolic
acid) (PLGA) intravitreal insert (OZURDEX®) on the market, but
notes that “PLGA is not used widely for intraocular drug delivery, in
part because the kinetics of degradation and drug release are
irregular.” Kropp 244. In addition, Kropp notes that “PLGA has been
reported to show low compatibility with acid sensitive bio-
pharmaceuticals.” Id.
FF7. Kropp teaches that poly(ester amide) (PEA) polymers
are synthetic polycondensation products consisting of
biocompatible building blocks such as hydrophobic L-
Appeal 2020-005222
Application 15/301,473
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amino acids, aliphatic di-carboxylic acids and α,ω-diols.
The use of amino-acids as components of the PEA
polymers confers several advantages. Degradation in vivo
is accomplished by enzymes normally present in tissues,
degradation begins at the surface allowing controlled
zero order degradation.
Kropp 245. Other advantages of PEA include “[t]he ability to
encapsulate and release a variety of drug species, including protein
drugs, coupled with the lack of side effects of degradation products
and versatile processability of the PEA polymers to be manufactured
as injectable fibrils and microparticles, makes PEA platform ideal as a
vehicle for the prolonged delivery of ophthalmic drugs.” Id.
FF8. Franken teaches a poly(ester amide) (PEA) having a general chemical
formula described by structural formula (I):

Formula I shows the generic chemical structure encompassed by
Franken’s therapeutic agents. Franken discloses the synthesis (see
Franken 13:1–5) of PEA III Ac Bz having the following structure:
Appeal 2020-005222
Application 15/301,473
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The chemical structure shown above is PEA III Ac Bz. See Franken
12:15–16.
FF9. Franken teaches that “the extruded or injection molded parts may be
any suitable medical substrate that can be injected in a human or
veterinary patient via a pharmaceutical syringe needle having a bore
of about 18-30 Gauge . . . . Examples of such medical substrates
include particles, fibers, tubes or rods.” Franken 9:30–35.
FF10. Franken teaches incorporation of steroidal anti-inflammatory agents
such as betamethasone, dexamethasone, and triamcinolone acetonide
among others in the PEA polymer. Franken 6:15–35. Franken teaches
the incorporation of non-steroidal anti-inflammatory agent such as
ketoprofen. Id. at 7:19–22 (providing a list of non-steroidal anti-
inflammatory agents). Franken exemplifies the incorporation of the
antihistamine ketotifen and the prostaglandin latanoprost into the PEA
III Ac Bz formulation. See id. at 15–16 (Examples 1–2), Figures 1–2.
FF11. The Specification discloses the synthesis (see Spec. 13) of PEA-III-Bz
having the following structure:

Appeal 2020-005222
Application 15/301,473
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The chemical structure shown above is PEA III Bz. See Spec. 15. The
Specification exemplifies loading triamcinolone acetonide (TAA) into
microparticles. See id. at 12:5–10, 16:13–22.
FF12. Rodriguez-Galan teaches that poly(ester amid)s (PEA) polymers have
ester and amide groups as part of their chemical structure that provide
targets for degradation. Rodriguez-Galan teaches that “[p]roperties
like hydrophilic/hydrophobic ratio and biodegradability can easily be
tuned.” Rodriguez-Galan, Abstract.
PEAs with elastomeric and bioabsorbable characteristics
can also be used as coatings to which drugs can be
covalently conjugated. Furthermore, composition and
microstructure can be easily varied to allow a desired rate
of degradation and drug release. Degradation rate of
PEAs tends to increase with levels of inflammation, a
feature that can be taken into account to control a
treatment agent release rate (e.g., when the agent is
directly linked to polymer side chains).
Id. at 87.
B. Analysis
Claim 16 is directed to a method of treating pain or inflammation in a
patient. The only positively recited method step is the step of injecting the
formulation into a patient’s knee, hip, or shoulder. The remainder of the
claim describes the microparticles of the injectable formulation as being
made up of an analgesic and at least one polymer that comprises a
biodegradable polyesteramide copolymer of a particular structural formula.
The wherein clause of the claim further describes that the formulation has
certain characteristics once it is deposited into the patient environment.
Examiner finds that Bodick teaches using “corticosteroid
microparticle for treating pain and inflammation such as caused by
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osteoarthritis.” Ans. 4. Examiner finds that Bodick’s “corticosteroid
microparticle formulations are administered locally as a sustained release
drug form.” Ans. 4; FF1. Examiner acknowledges that Bodick teaches
PGLA microparticles but does not teach PEA particles. Ans. 5. Examiner
also acknowledges that Bodick does not “teach wherein the release rate of
the analgesic correlates with the local level of inflammation of the patient
. . . [or is] correlated with the presence of HL60 neutrophil-like cell lysate.”
Id. at 6.
Examiner looks to Franken for teaching an “agent dispersed in the
biodegradable polymer wherein the polymer is a PEA polymer.” Ans. 6;
FF8–FF10. Examiner finds that Franken’s substrates include particles.
Ans. 7; FF9. Examiner finds that Kropp teaches that PLGA drug release is
irregular and is not compatible with acid sensitive biopharmaceuticals.
Ans. 8; FF6–FF7. Examiner finds that Rodriguez-Galan teaches degradable
PEA for biomedical applications. Ans. 8; FF12. Examiner finds that
Rodriguez-Galan teaches that PEA can be tuned so as to adjust the rate of
degradation. Ans. 8. Specifically, Examiner finds that Rodriguez-Galan
teaches that “[d]egradation rate of PEA tends to increase with levels of
inflammation, a feature that can be taken into account to control a treatment
agent release rate.” Ans. 8; FF12.
Based on these disclosures, Examiner concludes that “[o]ne of
ordinary skill in the art before the effective filing date of the claimed
invention would have [had] a reasonable expectation of success to use the
PEA polymers [taught in Franken] in place of the PLGA polymers [taught in
Bodick].” Ans. 9. Examiner reasons that it would have been obvious to one
of ordinary skill in the art to substitute the PLGA polymer of Bodick for the
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PEA polymer of Franken with a reasonable expectation of success because
“Kropp teaches biodegradable PEA may overcome the difficulties of long
term sustained drug release (abstract) and overcome PLGA irregular drug
release with an initial burst release and PEA polymers have been developed
to be an efficient and useful drug delivery system.” Id. at 13 (“Thus it would
be obvious to one of ordinary skill [that] the PEA polymer may be used in
place of the PLGA polymer as both [Bodick] and [Franken] are directed to
microparticles which release the same drug in the body.”); Compare FF3,
with FF10.
We have reviewed Appellant’s contentions that Examiner erred in
rejecting the claims as obvious over Bodick, Franken, Kropp, and
Rodriguez-Galan. Appeal Br. 10–20; Reply Br. 2–10. We disagree with
Appellant’s contentions and adopt the findings concerning the scope and
content of the prior art and arguments set forth in Examiner’s Answer and
Final Office Action. We address Appellant’s arguments below.
1. Articulated rationale for replacing the polymers of Bodick
Appellant contends that there is no reason why a person of ordinary
skill in the art would have “replace[d] the polymers of Bodick with the
specific PEA claimed.” Appeal. Br. 10. Specifically, Appellant contends that
Examiner’s rationale of achieving reliable release without a high burst is a
different type of release than the release presently claimed. Id. at 11 (“The
claimed invention instead specifies a release rate that correlates with the
local level of inflammation of a patient (Claim 16) or the presence of HL60
neutrophil-like cell lysate (Claim 25).”). Appellant contends that Examiner’s
characterization that all PEAs degrade in response to all inflammation and
all enzymes is overbroad. Reply Br. 4. Appellant contends that exposure to
“α-chymotrypsin [which] is a specific [digestive] enzyme that is not present
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Application 15/301,473
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in the inflammation cascade processes in the knee, hip, or shoulder of a
human or veterinary patient . . . [would not lead] PHOSITA to reasonably
expect that microparticles of the specific PEA claimed would perform in the
manner claimed.” Id. at 5.
We are not persuaded by Appellant’s contention and agree with
Examiner that Franken “teaches a PEA polymer [that] is taught as timed
release of a bioactive agent in a consistent and reliable manner . . . in the
form of a particle.” Ans. 12; FF10. Examiner explains that one of ordinary
skill in the art at the time the invention was made would have understood
that “PEA may overcome the difficulties of long term sustained drug release
([see Kropp] abstract) and overcome PLGA irregular drug release with an
initial burst release and PEA polymers have been developed to be an
efficient and useful drug delivery system.” Ans. 13; FF6–FF7. We find that
recognizing that drug release from PLGA may be irregular and that the
polymer has low compatibility with acid sensitive-biopharmaceuticals
provides a sufficiently articulated reason to formulate a drug delivery system
using other polymers such as PEA polymers, including PEA II Ac Bz, taught
by Franken, which is identical to the PEA disclosed in the Specification and
encompassed by the claims. Compare FF8 (Formula III: PEA III Ac Bz),
with FF11.
Franken teaches that PEA II Ac Bz can be formulated to incorporate
triamcinolone acetonide and can be processed to form particles for
administration via a syringe. FF9–FF10. Thus, both Bodick and Franken
teach “microparticles of the same drug [i.e., the corticosteroid triamcinolone
acetonide] . . . directed to treatment of inflammation in the body through the
use of drug releasing microparticles.” Ans. 13; FF3, FF10. Based on these
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teachings, we agree with Examiner’s conclusion that it would have been
obvious to one of ordinary skill in the art to substitute the PEA of Franken
for the PLGA of Bodick. See Ans. 13 (“the PEA polymer may be used in
place of the PLGA polymer as both the [Bodick and Franken references] are
directed to microparticles which release the same drug in the body.”). It is
obvious to those skilled in the art to substitute one known equivalent for
another. See In re Omeprazole Patent Litig., 483 F.3d 1364, 1374 (Fed. Cir.
2007) (“[T]his court finds no . . . error in [the] conclusion that it would have
been obvious to one skilled in the art to substitute one ARC [alkaline
reactive compound] for another.”).
We agree with Appellant that Franken and Kropp exemplify release of
drugs in the eye. Appeal Br. 11. “Non-obviousness[, however,] cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references. . . . [The reference] must
be read, not in isolation, but for what it fairly teaches in combination with
the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986). Beside exemplifying release of drugs in the eye, Kropp teaches that
the degradation of PLGA and PEA differ, specifically, noting that
“degradation of PLGA [], which takes place in the bulk via cleavage of its
backbone ester linkages into oligomers and finally monomers.” Kropp 250.
While the “degradation of PEA fibrils appears to take place by surface
erosion, suggesting that barrier properties of PEA matrix will be preserved
during the entire life-time of the implant [], a characteristic that would allow
PEAs to be used for the fabrication of long-term, controlled release devices.”
Id. Appellant has not provided an evidentiary basis from which to conclude
that the scientific observation about the degradation behavior of PEA by
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enzymes in Kropp is limited to application in the ocular environment and
would not reasonably transfer to the intra-articular environment disclosed in
Bodick.
We are also not persuaded by Appellant’s contention that there is no
reason to combine the references because they each exemplify different
structures from the presently claimed microparticles. Appeal Br. 12 (Bodick
deals with particles, Kropp directed to microfibrils, and “Franken
exemplifies only discs formed by casting films . . . and an extruded fiber
prepared via a twin-screw miniextruder.”). It is well settled that disclosed
examples and preferred embodiments do not constitute a teaching away from
a broader disclosure or even non-preferred embodiments. See In re Susi, 440
F.2d 442, 446 n.3 (CCPA 1971). Here, Bodick teaches the injection of
microparticles (FF1), and even suggests a size range of the particles in order
to administer them via a syringe (FF3). Kropp may have exemplified
microfibrils but nevertheless also suggests the PEA can be manufactured as
microparticles for injection. FF7 (“[t]he ability to encapsulate and release a
variety of drug species, including protein drugs, coupled with the lack of
side effects of degradation products and versatile processability of the PEA
polymers to be manufactured as injectable fibrils and microparticles, makes
PEA platform ideal as a vehicle for the prolonged delivery of ophthalmic
drugs.”). Franken similarly exemplifies films but also suggests that the
substrates can “include particles, fibers, tubes or rods” “that can be
injected.” FF9. Accordingly, we agree with Examiner’s position that the
combined references suggest manufacturing microparticles for the
administration to a patient population.
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Appellant contends that “PEA covers a wide spectrum of materials
and does not specifically indicate the claimed PEA.” Appeal Br. 14.
Appellant contends that Examiner’s reliance on the generic teachings of
Rodriguez-Galan is misplaced because “the properties of PEAs do not
specify any specific PEAs or any location of inflammation that would lead
one of ordinary skill in the art to have a reasonable expectation of success of
achieving the claimed invention involving specific claimed PEAs.” Id.
(emphasis omitted).
We are not persuaded.
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Here, Appellant has
not directed us to any information necessary for reaching a conclusion of
obviousness that was only been gleaned from Appellant’s Specification.
Examiner is not relying on Rodriguez-Galan for teaching the specific PEA
claimed. Examiner relies on Franken for that teaching. See FF8–FF10.
Instead Examiner is using the more generic teachings of Rodriguez-Galan to
further support the position that a person of ordinary skill in the art at the
time the invention was made would have understood that formulating
compositions using PEA has certain advantages. In other words, Examiner
looks to Rodriguez-Galan as providing additional reasons why a person of
ordinary skill in the art would have had a reasonable expectation of success
in substitution of Franken’s PEA polymer for the PLGA polymer of Bodick.
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2. Reasonable expectation of success
Appellant contends that a person of ordinary skill in the art would not
have had a “reasonable expectation of success of achieving a stimulus-
responsive class of release as claimed.” Appeal Br. 15. Appellant contends
that Examiner’s reliance on triamcinolone acetonide, mentioned in both
Bodick and Franken “say[s] nothing about whether the claimed release could
be achieved merely because the same drug may be delivered to the eye
(Franken) or knee (Bodick).” Appeal Br. 16 (emphasis omitted). Appellant
contends that the degradation can be different depending on the species of
PEA. Reply Br. 4 (“some enzymes may degrade a given species of PEA and
some enzymes may not.”). Appellant contends that the Examiner’s reasoning
“contains reversible error because it does not make a credible case that the
claimed release was predictable and expected.” Id. at 3.
We are not persuaded. Bodick teaches intra-articular injection of
biodegradable corticosteroid PLGA microparticles. FF1–FF5. Franken
teaches the use of biodegradable PEA polymers and suggests incorporating
anti-inflammatory agents such as triamcinolone acetonide. FF10. Franken
exemplifies PEA having the same structure as presently claimed. Compare
FF8, with FF11. Kropp teaches that biodegradable PLGA has certain
disadvantages for prolonged drug delivery, thereby motivating the use of
biodegradable PEA as a platform for prolonged drug delivery. FF6–FF7.
Based on these disclosures, we agree with Examiner “there is a reason to
substitute PEA [of Franken] for PLGA [of Bodick] and a reasonable
expectation of success” when injecting the PEA anti-inflammatory into an
intra-articular space. Ans. 18.
Examiner explains:
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Rodriguez-Galan teaches that biodegradation tests showed that
these copolymers could be enzymatically hydrolyzed by alpha-
chymotrypsin even at a low enzyme concentration, although
their hydrolysis in pure PBS buffer medium was slow (page 80,
first paragraph). Degradation rate of PEA tends to increase with
levels of inflammation, a feature that can be taken into account
to control a treatment agent release rate (page 87, second
paragraph). The biodegradation of the PEA polymer is taught to
increase in an enzyme solution increased with an increase in the
enzyme concentration content (page 89, second paragraph),
thus teaching that the PEA polymers are known to biodegrade
in response to inflammation and in connection with enzyme
release.
Ans. 20–21.
We agree with Examiner that the combined references suggest
substituting the PEA of Franken for the PLGA of Bodick. See Ans. 21.
While a new and nonobvious method of using an existing (or
obvious) composition may itself be patentable, see Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed.Cir.2005), a
newly-discovered result or property of an existing (or obvious)
method of use is not patentable. See Abbott Labs. v. Baxter
Pharm. Prods., 471 F.3d 1363, 1368-69 (Fed.Cir.2006);
Brassica Prot. Prods. LLC v. Sunrise Farms (In re Cruciferous
Sprout Litig.), 301 F.3d 1343, 1350-51 & n. 4 (Fed.Cir. 2002);
Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368,
1376 (Fed.Cir. 2001).
Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1295–296 (Fed. Cir. 2013)
(emphasis omitted); see, e.g., In re Wilder, 429 F.2d 447, 450–52 (CCPA
1970) (holding that where the claim defined nothing more than a
composition containing particular ingredients, the recitation “of a particular
property said to be possessed by the recited composition” did not change the
scope of the claim). Examiner explains that Franken “teaches a PEA
polymer to be used in the body, thus the degradation rate via enzymes and
inflammation would be relevant and would be a property of the polymer
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selected in [Franken].” Ans. 21. We agree with Examiner that when
administering the same composition to the same patient population, the
resulting analgesic release from the composition would similarly be
expected to correlate with the level of inflammation in the environment
where the composition is administered. Accordingly, we agree with
Examiner that this is an inherent result of administering the anti-
inflammatory containing PEA polymer taught in Franken.
3. Unexpected results
Appellant contends that claims 34 and 42 “additionally require that
the microparticles do not show evidence of agglomeration when comparing
the average diameter of the microparticles as measured by light scattering
after immersion in water for 10 minutes and the average diameter of the
microparticles after immersion in water for 400 minutes.” Appeal Br. 18.
Appellant contends that Bodick recognizes that certain PEG/PGLA
combinations suffered from undesirable agglomeration. Id. Appellant
contends that a person having ordinary skill in the art at the time the
invention was made “could [not] reasonably predict the ability of post-
processed microparticles of certain sizes to resist agglomeration in water
over a period of time.” Id. at 19. Appellant contends that the inventive
microparticles show surprising results because they “do not show
agglomeration after being immersed in water for 400 minutes.” Id. (citing
Spec. 19–20 (Example 4)).
We are not persuaded and agree with Examiner that the evidence
advanced by Appellant to show an unexpected result is not sufficient when
considered together with the evidence of obviousness to establish non-
obviousness. According to Examiner, Franken “teaches microparticles
formed of the elected polymer containing an active agent which are sized to
Appeal 2020-005222
Application 15/301,473
19
be injected through 18 to 30 gauge needle and thus must be sized below the
inner needle diameter.” Ans. 24; FF9. The Specification provides that “PEA-
III-Bz did not agglomerate[] during the course of the experiment, [while]
PEA-I-Bz particles were showing agglomeration after only 10 minutes of
immersion in water. Agglomerated particles reduces the syringe-ability of
those particles through a narrow needle.” Spec. 19 (Experiment 4). We agree
with Examiner that “Appellant has not compared particle agglomeration to
the closet prior art.” Ans. 24; Compare FF8, with FF11. 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 PEA compound were unexpectedly superior compared to
the closest prior art, which are the compositions disclosed by Franken (FF8).
See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
CONCLUSION
We conclude that the evidence cited by Examiner supports a prima
facie case of obviousness and Appellant has not provided persuasive
evidence to rebut the prima facie case. As Appellant does not argue the
claims separately, claims 18, 19, 25–27, 29, 30, 32, 33, 35–37, and 39–41
fall with claims 16, 34, and 42. 37 C.F.R. § 41.37 (c)(1)(iv).
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
16, 18, 19,
25–27, 29,
103 Bodick, Franken,
Kropp, Rodriguez-
Galan
16, 18, 19,
25–27, 29,

Appeal 2020-005222
Application 15/301,473
20
30, 32–37,
39–42
30, 32–37,
39–42

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED