Ex Parte Nivaggioli et al

Board of Patent Appeals and Interferences

Sep 21, 2010

10340237 (B.P.A.I. Sep. 21, 2010)

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.
10/340,237 01/09/2003 Thierry Nivaggioli 440882001000 5305
7590 09/21/2010
Allergan Inc
Stephen Donovan Esq
2525 Dupont Drive
Mailstop T2-7H
Irvine, CA 92612
EXAMINER
HARTLEY, MICHAEL G
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
09/21/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte THIERRY NIVAGGIOLI, LIN PENG, DAVID CHOU,
and DAVID WEBER,
Appellants1
____________________

Appeal 2009-013914
Application 10/340,237
Technology Center 1600
____________________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and
STEPHEN WALSH, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL2

1 The real party in interest is ALLERGAN, INC. (Appeal Brief on Behalf of
Appellants under 37 C.F.R. § 41.37 filed 23 April 2007 ("App. Br.") at 5).
This decision also cites the Examiner's Answer mailed 20 August 2007
("Ans."), the Reply Brief filed 20 November 2007 ("Reply Br."), and the
Specification of Application 10/340,237 ("Spec.").
2 The two-month period for filing an appeal or commencing a civil action, as
recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited
in 37 C.F.R. § 41.52, begins to run from the "MAIL DATE" (paper delivery
mode) or the "NOTIFICATION DATE" (electronic delivery mode) shown
on the PTOL-90A cover letter attached to this decision.
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2
Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of all pending claims, claims 10, 14-19, 21-24, and 90-98 (App. Br.
5; Ans. 2; Reply Br. 2). Oral arguments were held September 16, 2010. We
have jurisdiction under 35 U.S.C. § 134. We AFFIRM.
I. Statement of the Case
The subject matter on appeal is directed to biodegradable implants for
delivering at least a steroidal anti-inflammatory agent to the eye. The
implants are typically solid and in the form of particles, sheets, patches,
films, discs, fibers, and rods (Spec. 15, ¶ 55). Claim 10 is illustrative and
reads (App. Br. 21, paragraphing added):
10. A bioerodable implant for treating a medical
condition of the eye comprising
an active agent dispersed within a
biodegradable polymer matrix,
wherein the bioerodable implant is formed by
an extrusion method,
wherein the bioerodable implant has an in
vivo in rabbit eye cumulative release profile in
which less than about 15 percent of the active
agent is released about one day after implantation
of the bioerodable implant and greater than about
80 percent of the active agent is released about 28
days after implantation of the bioerodable implant,
and
wherein the biodegradable polymer matrix
comprises a mixture of polylactide/polyglycolide
(PLGA) copolymer having hydrophilic end groups
and PLGA having hydrophobic end groups in a
weight to weight ratio of hydrophilic end group
PLGA to hydrophobic end group PLGA of about
3:1,
wherein the active agent comprises a
steroidal anti-inflammatory agent.

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Claim 90, the only other independent claim on appeal, does not recite how
the implant is formed and broadly recites an in vivo release profile in an eye.
Claims 15 and 92 limit the steroidal anti-inflammatory agent of claims 10
and 90, respectively, to dexamethasone.
The Examiner rejected claims 10, 14-19, 21-24, and 90-98 as obvious
under 35 U.S.C. § 103(a) over Wong3 in view of Setterstrom4 (Ans. 3-4).
The Examiner found that Wong teaches ocular implants comprising
dexamethasone, a PLGA matrix, and rate modifiers which control the
release of the dexamethasone (Ans. 3, 10). The Examiner found that Wong
failed to teach implants (a) wherein the PLGA matrix comprised a mixture
of hydrophilic and hydrophobic end groups as claimed or (b) having the
claimed release profile (id. at 3). The Examiner found that Setterstrom
teaches controlling the release of an active agent embedded in a PLGA
matrix between 1 and 100 days by varying the ratio of uncapped
(hydrophilic end) polymer to capped (hydrophobic end) polymer (id. at 3-4).
The Examiner pointed to Figure 47 of Setterstrom as showing an active
agent release profile wherein less than about 15% of drug is released in less
than one day and greater than 80% is released after 28 days (id. at 4).
According to the Examiner, it would have been a matter of routine
optimization to provide a programmable release profile given the guidance
provided by Setterstrom (id. at 10-11). The Examiner concluded that it

3 US Patent 5,869,079, Formulation for Controlled Release of Drugs by
Combining Hydrophilic and Hydrophobic Agents, issued 9 February 1999 to
Wong et al. ("Wong").
4 US Patent 6,309,669 B1, Therapeutic Treatment and Prevention of
Infections with a Bioactive Materials Encapsulated within a Biodegradable-
Biocompatible Polymeric Matrix, issued 30 October 2001 to Setterstrom et
al. ("Setterstrom").
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would have been obvious to one of ordinary skill in the art to use the PLGA
matrix of Setterstrom in the implants of Wong, also made from these types
of PLGA polymers, to provide implants with a desired release profile
without any bursts or lags in release (id.).
Appellants argue that Wong and/or Setterstrom fail to teach or suggest
the claimed 3:1 w/w hydrophilic to hydrophobic end group PLGA polymer
(App. Br. 12-13). Appellants further argue that there is no reason or
motivation to combine Wong and Setterstrom, absent impermissible
hindsight, because Wong teaches that modifying an implant's drug release
profile is unpredictable and Setterstrom fails to provide any teachings or
guidance that would render Wong's trial-and-error experimentation
unnecessary (App. Br. 13-16, 18-19; Reply Br. 11-13). Appellants still
further argue that Wong and Setterstrom teach away from the claimed
invention (id. at 16). In particular, Wong teaches that a release modifier
(i.e., an accelerant) must be added to the implant and Setterstrom (i) teaches
using microcapsules for sustained drug release, (ii) fails to teach forming
implants by an extrusion method, and (iii) describes a release profile in
Figure 50 wherein appreciable drug release does not occur until after day 56
(App. Br. 17-18).
Based upon Appellants' patentability arguments, we decide this appeal
on the basis of claims 10 and 90. 37 C.F.R. § 41.37(c)(1)(vii). At issue is
whether the evidence of record supports the Examiner's conclusion that it
would have been obvious to one of ordinary skill in the art to modify the
PLGA matrix of Wong's implant based on the teachings of Setterstrom to
obtain the claimed subject matter with a reasonable expectation of success
absent improper hindsight reconstruction.
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II. Findings of Fact
The following findings of fact ("FF") are supported by a
preponderance of the evidence of record.
A. Wong
[1] Wong discloses a biodegradable implant formulated for controlled,
sustained release of a drug, wherein a release modulator is added to
the implant to control release of the drug therefrom (Wong abstract;
col. 1, ll. 8-9; col. 2, ll. 27-35), especially for use in treatment of
ocular conditions (id. at col. 6, ll. 27-29).
[2] According to Wong, the rate of release of the drug is controlled by the
rate of transport through the polymeric matrix of the implant and the
action of the release modulator (id. at col. 2, ll. 37-39).
[3] Transport through the polymeric matrix is affected by drug solubility,
polymer hydrophilicity, extent of polymer cross-linking and water
absorption, geometry of the implant, and so on (id. at col. 2, ll. 47-52).
[4] The implant may be in the form of particles, sheets, patches, plaques,
fibers, or microcapsules in any size or shape compatible with the
selected site of insertion (id. at col. 5, ll. 15-17; col. 7, ll. 40-65).
[5] The release modulator may be an accelerator or a retardant (id. at col.
2, ll. 53-55).
[6] Accelerators are hydrophilic entities, such as low molecular weight
hydroxypropylmethyl cellulose ("HPMC"), sugars, dextrans, and
polysaccharides; while retardants are hydrophobic entities, such as
high molecular weight HPMC and low water soluble organic
compounds (id. at col. 3, ll. 7-col. 4, l. 11).
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[7] Hydrophilic accelerators are used in combination with hydrophobic
agents to increase the rate of release (id. at col. 2, ll. 55-57).
[8] Example 1 illustrates an implant containing dexamethasone (a
hydrophobic agent) in a PLGA polymeric matrix containing a
hydrophilic HPMC release modifier, wherein the implant was formed
by an extrusion method (id. at col. 8, ll. 20-9:5), although a variety of
other techniques may be used to produce implants (id. at col. 8, ll. 4-
14).
[9] According to Wong, "[b]y selection of the appropriate polymer and
release modifier, drug release and delivery interval can be custom-
tailored to provide a release profile that is accelerated or retarded" (id.
at col. 9, ll. 1-4).
[10] For example, a USP approved method for dissolution or release
testing, i.e., "USP 23; NF 18 (1995) pp. 1790-1798," can be used to
determine the proportion of modulator and active agent required to
provide an expected duration of action in vivo (id. at col. 4, ll. 34-58).
[11] Regarding PLGA, Wong states that "the rate of biodegradation is
controlled by the ratio of glycolic to lactic acid. The most rapidly
degraded copolymer has roughly equal amounts of glycolic and lactic
acid, where either homopolymer is more resistant to degradation." (Id.
at col. 5, ll. 62-67.)
B. Setterstrom
[12] Setterstrom discloses encapsulating active agents, including peptides
and drugs, within a PLGA polymeric matrix comprising a blend of
uncapped and end-capped PLGA forms in a ratio ranging from 100/1
to 1/99 to provide for burst-free programmable sustained release of
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the active agent over a period of up to 100 days in an aqueous
physiological environment (Setterstrom abstract; col. 1, ll. 32-39; col.
7, ll. 50-55; col. 8, ll. 19-23, 42-67; col. 21, ll. 21-42; col. 27, ll. 30-
32; col. 71, ll. 66-col. 72, l. 37; col. 91, ll. 18-28; col. 92, ll. 64-67;
col. 93, ll. 51-67).
[13] According to Setterstrom,
[t]he 'uncapped' form refers to
"poly(lactide/glycolide) with free carboxyl end
groups" which renders the polymer more
hydrophilic compared to the routinely used end-
capped form. Currently used 'end-capped' polymer
hydrates between 4-12 weeks depending on the
molecular weight, resulting in an intermediate 'no
release' or a 'lag phase'. The uncapped polymer
hydrates typically between 5 to 60 days depending
on the molecular weight, thus releasing its core
continuously without a lag phase. A careful blend
of the two forms and appropriate molecular
weights and L/G ratios, results in a continuous
release between 1 to 100 days. (Id. at col. 93, ll. 1-
11.)

[14] Further according to Setterstrom,
[u]nlike currently available release systems,
which rely on the use of fillers/additives such as
… dextran, …sugars, etc., and are still prone to
low encapsulation efficiencies and "burst effects",
this invention achieves high encapsulation and
"burst-free" release without the use of any additive
… burst-free, programmable sustained release is
achieved through the use of a unique blend of the
'uncapped' and end-capped forms of
poly(lactide/glycolide) polymer in the molecular
weight range of 2,000 to 60,000 daltons. (Id. at
col. 92, ll. 3-12.)

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[15] Specifically, copolymers between 2,000 to about 60,000 daltons, with
molar compositions of lactide/glycolide from 90/10 to 40/60, and a
blend of uncapped and end-capped forms in a ratio of 100/0 to 1/99
provide encapsulation efficiencies of about 80 to 100% depending on
the polymer molecular weight and structural form (id. at col. 92, ll.
23-30).
[16] "[R]elease profiles of variable rates and durations are achieved by
blending uncapped and capped microspheres as a cocktail in variable
amounts" (id. at col. 25, ll. 1-4) or "by blending uncapped and capped
polymers in different ratios within the same microspheres" (id. at col.
25, ll. 5-8).
[17] Exemplary drugs include anti-inflammatory agents such as hormonal
agents; hydrocortisone; prenisolone; prednisone (id. at col. 10, l. 62-
col. 12, l. 55, especially col. 12, ll. 10-11; col. 21, l. 54-col. 23, l. 57,
especially col. 23, ll. 7-9).
[18] Setterstrom encompasses both direct local delivery and indirect
systemic delivery of active agents (id. at col. 8, ll. 6-52).
[19] Figure 47 of Setterstrom is a hepatitis B surface antigen ("HBsAg")
release curve obtained using 50:50 poly(DL-lactide-co-glycolide) (id.
at col. 20, ll. 45-46). Setterstrom is silent regarding the ratio of
uncapped and capped PGLA polymers. Figure 47 is reproduced
below:
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{Figure 47 of Setterstrom illustrates a release curve from hepatitis
B surface antigen encapsulated in 50:50 DL:PLG.}

[20] Figure 50 of Setterstrom depicts
cumulative Histatin release from PLGA
microspheres from several batches prepared using
50/50 and 75/25 uncapped and end-capped,
polymer modulates release between 1 to 100 days
by varying the process parameters. 1-35 days by
uncapped 50/50, 18-56 days by capped 50/50 and
56-100 by capped 75/25. (Id. at col. 98, ll. 29-35.)

Figure 50 is reproduced below.

{Figure 50 of Setterstrom shows cumulative histatin release
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profiles from several batches of PLGA microspheres.}

[21] According to Setterstrom, burst-free, variable release from 1-35 days
(compositions 1, 2, 4, 12-14, and 16-18), from 28-70 days
(compositions 10 and 11), and from 56 to 90 days (compositions 8
and 9) is achieved by varying the polymer concentration in the oil
phase of the process used to make the microspheres (id. at col. 100, ll.
20-34 (Example 13); col. 100, ll. 61-col. 101, l. 4 (Example 16); col.
102, ll. 30-41 (Example 19)).
[22] Table 16 of Setterstrom describes the compositions of the
microspheres 1, 2, 4, 8-14, and 16-18 used in Figure 50 and reads as
follows (id. bridging columns 105-106):

III. Discussion
A. Legal principles
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An invention is obvious if "the differences between the subject matter
sought to be patented and the prior art are such that the subject matter as a
whole would have been obvious . . . to a person having ordinary skill in the
art to which said subject matter pertains." 35 U.S.C. § 103. The factual
inquiries underlying obviousness include (1) the scope and content of the
prior art, (2) the differences between the prior art and the claims at issue, (3)
the level of ordinary skill in the art at the time the invention was made, and
(4) any objective evidence of nonobviousness. Graham v. John Deere Co.
of Kansas City, 383 U.S. 1, 17-18 (1966). In determining whether
obviousness is established by combining the teachings of the prior art, "the
test is what the combined teachings of the references would have suggested
to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425 (CCPA
1981). In addition, a reference disclosure is not limited only to its preferred
embodiments, but is available for all that it discloses and suggests to one of
ordinary skill in the art. In re Lamberti, 545 F.2d 747, 750 (CCPA 1976); In
re Mills, 470 F.2d 649, 651 (CCPA 1972). Furthermore, skill in the art is
presumed. In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985).
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). For example,
"discovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,
276 (CCPA 1980).
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"Obviousness does not require absolute predictability of success . . .
all that is required is a reasonable expectation of success." In re O'Farrell,
853 F.2d 894, 903 (Fed. Cir. 1988). The presence of a reasonable
expectation of success is measured from the perspective of a person of
ordinary skill in the art at the time the invention was made. Life Techs., Inc.
v. Clontech Labs., Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000). However,
"[a] reference may be said to teach away when a person of ordinary skill,
upon reading the reference, would be discouraged from following the path
set out in the reference, or would be led in a direction divergent from the
path that was taken by the applicant." In re Gurley, 27 F.3d 551, 553 (Fed.
Cir. 1994).
B. Discussion
The subject matter on appeal is directed to biodegradable implants
comprising a steroidal anti-inflammatory agent, such as dexamethasone, in a
PLGA polymeric matrix having a hydrophilic end group to hydrophobic end
group ratio of about 3:1 and providing a cumulative drug release profile
wherein less than about 15% of the drug is released about one day after
implantation and about 80% of the drug is released by about 28 days after
implantation. Here, we agree with the Examiner that it would have been
obvious to one of ordinary skill in the art to use the PLGA matrix of
Setterstrom in the implants of Wong to provide implants with a desired
release profile without any bursts or lags in release.
Wong teaches adding modulators to provide controlled, sustained
release of a drug contained in an implant made from a PLGA matrix for use
in treating ocular conditions (FF 1). These modulators may be hydrophilic
entities, such as low molecular weight HPMC, sugars, and dextrans, or
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hydrophobic entities, such as high molecular weight HPMC or low water
soluble organic compounds (FF 5-6). Wong expressly teaches using
hydrophilic modulators in combination with hydrophobic agents to increase
their rate of release (FF 7). Wong also expressly teaches modulating the
release of dexamethasone, a hydrophobic steroid, from a PLGA-based
implant with low molecular weight HPMC, a hydrophilic modulator (FF 8).
Setterstrom discusses prior art release systems that rely on the use of
added modulators, such as dextrans and sugars, but point out that such
systems are prone to low encapsulation efficiencies and burst effects (FF
14). Setterstrom teaches encapsulating an active agent, such as a steroid,
within a PLGA polymeric matrix comprising a blend of uncapped
(hydrophilic end) and end-capped (hydrophobic end) PLGA forms in a ratio
ranging from 100/1 to 1/99 to provide burst-free, programmable sustained
release of the active agent over a period of up to 100 days in an aqueous
physiological environment (FF 12-13, 16-17).
Thus, the combined teachings of Wong and Setterstrom reasonably
suggest using a blend of uncapped (hydrophilic end) and end-capped
(hydrophobic end) PLGA forms to provide burst-free, programmable
sustained release of a steroid, such as dexamethasone, in biodegradable
implant which does not require an added modulator and is suitable for use in
treating ocular conditions. Appellants' arguments do not persuade us
otherwise.
While neither Wong nor Setterstrom explicitly teach the claimed 3 to
1 ratio of hydrophilic end PLGA to hydrophobic end PLGA forms, Wong
expressly teaches using a hydrophilic modulator to control release of a
hydrophobic drug, e.g., dexamethasone (FF 7-8). A blend of PLGA forms
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wherein the ratio of hydrophilic end PLGA to hydrophobic end PLGA forms
is greater than 1 would reasonably have been expected to produce a net
hydrophilic copolymer, with increasing amounts of the hydrophilic end
PLGA form resulting in an increasingly hydrophilic copolymer. Where a
conclusion of obviousness is based on the combined teachings of the prior
art, the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art. Keller, 642 F.2d at 425. In
addition, Setterstrom provides an explicit reason for modifying a modulator-
containing PLGA release system such as Wong's, i.e., such release systems
are prone to low drug encapsulation efficiencies and burst effects (FF 14).
Therefore, arguments attacking Wong and Setterstrom individually and
alleging a lack of motivation to combine their teachings are not persuasive
of patentability.
Arguments alleging unpredictability are also unpersuasive. In our
opinion, Wong and Setterstrom establish that optimizing a desired release
profile for a given drug encapsulated in a PLGA polymeric matrix is well
within ordinary skill in the art and Appellants have not introduced evidence
to the contrary. According to Wong, a desired drug release profile can be
custom-tailored by selecting the appropriate polymer and release modifier
(FF 9). Wong expressly uses hydrophilicity to modulate release of a
hydrophobic drug (FF 7-8). Setterstrom specifically teaches using PLGA
copolymers within a defined weight range, with a defined range of molar
compositions, and a blend of uncapped (hydrophilic) and end-capped
(hydrophobic) forms to provide high encapsulation efficiencies and burst-
free release without the use of any additive (FF 15-16). Figure 47 of
Setterstrom shows, for example, the release profile of HBsAg encapsulated
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in a 50:50 poly(DL-lactide-co-glycolide) matrix. Wong teaches that the
most rapidly degraded copolymer has roughly equal amounts of glycolic and
lactic acid (FF 11). Figure 50 of Setterstrom demonstrates cumulative
histatin release profiles from several batches of PLGA microspheres wherein
initial release was varied by varying the polymer concentration in the oil
phase of the process to make the microspheres (FF 20-21). We also note in
passing that Wong cites an approved USP method for dissolution or release
testing (FF 10). Thus, we agree with the Examiner, that "any
experimentation required by the artisan to make [the] instant invention
would be merely a matter of routine optimization" (Ans. 10, original
emphasis) (see also Ans. 6-7). Skill in the art is presumed. Sovish, 769 F.2d
at 743, and "discovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art." Boesch, 617 F.2d at
276. In our view, based on the evidence of record, the Examiner has not
engaged in impermissible hindsight reconstruction of the claimed invention.
McLaughlin, 443 F.2d at 1395.
Finally, arguments that the references "teach away" from the claimed
invention are similarly unpersuasive of patentability. First, both Wong and
Setterstrom teach or suggest using hydrophilicity and hydrophobicity to
control release of an active agent depending on the hydrophobic/hydrophilic
nature of the agent -- Wong uses accelerator and retardant modulators (FF
5), Setterstrom uses a blend of uncapped and end-capped PLGA forms (FF
12). Second, arguments directed to forming implants by an extrusion
method are only applicable to the method of claim 10, as claim 90 recites no
such limitation, and Wong not only teaches forming an implant by extrusion,
but also teaches that a variety of other techniques may be used to produce
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implants (FF 8). Third, we agree with the Examiner that Figure 50 is but
one specific working example in Setterstrom and that it is the overall
teachings of Setterstrom that must be considered (see Ans. 9). In re
Lamberti, 545 F.2d at 750 (A prior art reference must be considered in its
entirety and is not limited to preferred embodiments or specific working
examples.)
As to Figure 50 of Setterstrom, on the one hand, Appellants argue that
"the '75/25' sample profiles reported at the far right of FIG 50 relate to a
75/25 (i.e. 3/1) ratio that is not the 3:1 hydrophilic:hydrophobic ratio
claimed by Appellants" (App. Br. 17). On the other hand, Appellants argue
that the "75/25" ratio in Figure 50 refers to a 75/25 lactide/glycolide
copolymer ratio of 100% uncapped forms (Reply Br. 4). Table 16 of
Setterstrom lists the L/G ratio & type of the compositions of Figure 50 (FF
22). According to Table 16, "U" indicates uncapped polymers (FF 22).
According to Table 16, the L/G ratio & type of compositions 8 and 9 are
both "75/25" (FF 22). Regardless of which of Appellants' interpretations of
compositions 8 and 9 is correct, Setterstrom expressly teaches that burst-free
variable release rates from 1-35 days (compositions 1, 2, 4, 12-14, and 16-
18), from 28-70 days (compositions 10 and 11), and from 56 to 90 days
(compositions 8 and 9) illustrated in Figure 50 are achieved by varying the
polymer concentration in the oil phase of the process used to make the
microspheres (FF 20-21). Appellants have not explained how one result-
effective variable, i.e., varying the polymer concentration in the oil phase of
the process used to make the microspheres, teaches away from another
result-effective variable, i.e., using a blend of uncapped (hydrophilic end)
and end-capped (hydrophobic end) PLGA forms. Therefore, Setterstrom's
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Figure 50 does not teach away from the claimed invention. Thus, neither
Wong nor Setterstrom teaches away from following the path set out therein,
i.e., using hydrophilicity and hydrophobicity to control release of an active
agent, or in a direction divergent from the path taken by Appellants. Gurley,
27 F.3d at 553.
C. Conclusion
Upon consideration of the evidence and the respective positions of
both the Examiner and the Appellants, we sustain the rejection of claims 10,
14-19, 21-24, and 90-98 as obvious over the combined teachings of Wong
and Setterstrom. The evidence of record supports the Examiner's conclusion
that it would have been obvious to one of ordinary skill in the art to modify
the PLGA matrix of Wong's implant based on the teachings of Setterstrom to
obtain the claimed subject matter with a reasonable expectation of success.
The Examiner only relied on knowledge which was within the level of
ordinary skill at time the claimed invention was made and not knowledge
gleaned only from applicant's disclosure and, therefore, did not engage in
impermissible hindsight reconstruction of Appellants' claimed invention.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claims 10, 14-
19, 21-24, and 90-98 as unpatentable under 35 U.S.C. § 103(a) over Wong
in view of Setterstrom is AFFIRMED; and,
FURTHER ORDERED that 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
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cdc
ALLERGAN, INC.
STEPHEN DONOVAN, ESQ.
2525 DUPONT DRIVE
MAILSTOP T2-7H
IRVINE, CA 92612