Ex Parte Huang et al

Board of Patent Appeals and Interferences

Sep 24, 2010

10836880 (B.P.A.I. Sep. 24, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte GLENN T. HUANG and
THIERRY NIVAGGIOLI
__________

Appeal 2010-006865
Application 10/836,880
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a
biodegradable drug delivery implant and methods of making the implant.

1 The two-month time 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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The Examiner has rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1, 5-7, 10-18, 23, 26-29, and 31-34 are on appeal. Claims 1
and 16 are representative and read as follows:
1. A biodegradable drug delivery implant comprising:
a beta adrenergic receptor antagonist associated with a biodegradable
polymer matrix that releases drug at a rate effective to sustain release of an
amount of the beta adrenergic receptor antagonist from the implant for a
time effective to reduce intraocular pressure in an eye in which the implant
is placed,
the time being at least about one week after the implant is placed in
the eye,
wherein said beta adrenergic receptor antagonist is timolol and is
provided in an amount of from 10 to 26%, by weight, of said implant.

16. The implant of claim 1, wherein the implant is structured to be
placed in the anterior chamber of the eye.

Issue
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as being obvious in view of Wong ‘1162 and Wong ‘188.3 The
claims have been argued in two groups (Appeal Br. 10): claims 5-7, 10-15,
17, and 18 stand or fall with claim 1, and claims 23, 26-29, and 31-34 stand
or fall with claim 16.
The Examiner finds that Wong ‘116 discloses “biodegradable ocular
implants for the sustained release of glaucoma medications,” including β
adrenergic receptor antagonists (Answer 3). The Examiner further finds that

2 Wong et al., US 6,369,116 B1, Apr. 9, 2002
3 Wong, US 5,164,188, Nov. 17, 1992
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Wong ‘116 discloses that the “implant is formulated to release active agents
over a period from three weeks to about six months” (id.) and that the active
agent can be “between 10 to about 80 % by weight of the implant” (id.).
The Examiner finds that Wong ‘188 “is directed to biodegradable
ocular implants for the controlled release of drugs. Exemplified drugs
include beta blockers such as timolol maleate.” (Id. at 4.) The Examiner
concludes that “one would have been motivated to include timolol in the
implant of Wong [‘116] because it would have the pharmaceutical properties
required to effectively treat glaucoma” (id. at 4-5).
Appellants contend that the Wong patents do not suggest how to
effectively provide timolol as a sustained release drug (Appeal Br. 8-9) and
do not suggest a sustained release implant with 10 to 26% by weight timolol
(id. at 9-10). Appellants also contend that the Wong patents do not suggest
the “anterior chamber” limitation of claim 16 (Appeal Br. 10-11).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the cited references would
have made it obvious to make the products of claims 1 and 16 with a
reasonable expectation of success?
Findings of Fact
1. Wong ‘116 discloses that “biocompatible implants for introducing
into an anterior chamber or posterior segment of an eye for the treatment of
an ocular condition” are known in the art (Wong ‘116, col. 2, ll. 10-13).
2. Wong ‘116 discloses “[b]iodegradable implants … comprising a
biocompatible, biodegradable polymer and one or more active agents
configured for placement extrinsic to the vitreous either episclerally or
intrasclerally” to improve the success of glaucoma filtration therapy through
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sustained release of an active agent at the surgical site (id. at col. 2, ll. 47-
55).
3. Wong ‘116 discloses that its biodegradable implants can be made
from “polymers of D-lactic acid, L-lactic acid, racemic lactic acid, glycolic
acid, polycaprolactone, and combinations thereof” (id. at col. 3, ll. 31-37).
4. Wong discloses that
By employing the L-lactate or D-lactate, a slowly biodegrading
polymer is achieved, while degradation is substantially
enhanced with the racemate. In a particularly preferred
embodiment, copolymers of glycolic and lactic acid are used,
where 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.
Homopolymers, or copolymers having ratios other than equal,
are more resistant to degradation.
(Id. at col. 3, ll. 38-45.)
5. Wong ‘116 discloses that the “implant is formulated to release the
active agent(s) over a period of at least about three weeks” (id. at col. 3, ll.
56-60).
6. Wong ‘116 discloses that “[a]ctive agents which may find use in
the present invention … include … anti-glaucoma agents, e.g[.]
acetozolamide (dimox), befunolol, β-blockers, Ca-blockers, etc.” (id. at col.
4, ll. 24-42).
7. Wong ‘116 discloses that the amount of active agent will vary and
will usually “be at least about 1, more usually at least about 10 weight
percent of the implant, and usually not more than about 80, more usually not
more than about 40 weight percent of the implant” (id. at col. 7, ll. 22-28).
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8. Wong ‘188 discloses “implants … [that] are formulated to include
one or more agents which may be released over an extended period of time
… into the interior of an eye” (Wong ‘188, col. 2, ll. 21-24).
9. Wong ‘188 discloses that “drugs of interest include anti-glaucoma
drugs, such as the beta-blockers: timolol maleate, betaxolol and
metipranolol” (id. at col. 4, ll. 19-21).
10. Wong ‘188 discloses that “[i]mplants comprising the agent or
agents of interest … are generally encapsulated. The capsule, for the most
part, will be a polymeric encapsulating agent.” (Id. at col. 2, ll. 40-43.)
11. Wong ‘188 discloses that polymers “[o]f particular interest are …
polymers of D-lactic acid, L-lactic acid, racemic lactic acid, glycolic acid,
polycaprolactone, and combinations thereof” (id. at col. 2, l. 66 to col. 3,
l. 3).
12. Wong ‘188 discloses that “[b]y employing the L-lactate, a slowly
eroding polymer is achieved, while erosion is substantially enhanced with
the lactate racemate” (id. at col. 3, ll. 3-5).
13. Wong ‘188 discloses that the “period of administration will
usually be at least 3 days, more usually at least 7 days” (id. at col. 3, ll. 39-
41).
14. Wong ‘188 discloses that the “[u]sually the agent will be from
about 1 to 80, more usually 20 to 40 weight percent of the implant” (id. at
col. 5, ll. 1-5).
Principles of Law
“[A] prior art reference that discloses a range encompassing a
somewhat narrower claimed range is sufficient to establish a prima facie
case of obviousness. That is not to say that the claimed composition having
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a narrower range is unpatentable. Rather, the existence of overlapping or
encompassing ranges shifts the burden to the applicant to show that his
invention would not have been obvious.” In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003).
Analysis
Claim 1 is directed to a biodegradable ocular drug delivery implant
comprising 10-26% by weight timolol and a biodegradable polymer matrix,
where the implant sustainably releases the timolol for at least one week after
placement.
Both Wong patents disclose ocular drug delivery implants for the
treatment of glaucoma that comprise a beta adrenergic receptor antagonist
(i.e., a beta-blocker) associated with a biodegradable polymer. Wong ‘188
discloses that the beta-blocker may be timolol maleate. Both Wong patents
disclose that the biodegradable polymer provides sustained release of the
active agent for at least a week after placement, and disclose including
amounts of active agent in the implants that encompass or overlap the range
recited in claim 1. In view of these disclosures, it would have been obvious
to one of ordinary skill in the art to form a biodegradable ocular drug
delivery implant comprising timolol associated with a biodegradable
polymer matrix, with the implant being formulated to sustainably release the
timolol for at least one week after placement. The amounts of active agent
suggested by the Wong patents would have made obvious the range of
timolol recited in claim 1. See Peterson, 315 F.3d at 1329.
Appellants argue that neither of the Wong patents “suggests how to
provide timolol, e.g. timolol maleate, as a sustained release drug.… [T]he
appellant’s own work with timolol maleate salt and the free base, as
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disclosed in the present specification shows that timolol maleate does not
work as a sustained release system merely by following the general
teachings” of the Wong patents. (Appeal Br. 8-9).
This argument is not persuasive. The Wong patents disclose that their
implants release active agents, including beta-blockers like timolol, for
periods of more than one week (FFs 5, 13). Both the claimed and unclaimed
disclosures of a prior art patent are presumed to be enabled, and the
applicant bears the burden of proving that the relevant disclosure is not.
Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir.
2003). Appellants have not presented persuasive evidence that the
disclosures of the Wong patents would not have enabled a person of
ordinary skill in the art to make ocular implants that release timolol for one
week or more without undue experimentation.
Appellants also argue that a sustained release implant 10 to 26% by
weight timolol is not suggested by the cited references (Appeal Br. 8-9).
This argument is not persuasive. The cited references disclose
preferred ranges for weight percent active agent that overlap or encompass
the claimed range (FFs 7, 14). Thus, in accord with In re Peterson, the
burden shifts to Appellants to show that the claimed range of active agent
would not have been obvious; e.g., by showing that the claimed range is
unexpectely superior to other parts of the range suggested by the prior art.
See, e.g., In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990) (“[I]n such a
situation, the applicant must show that the particular range is critical,
generally by showing that the claimed range achieves unexpected results
relative to the prior art range.”).
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With respect to claims 16, 23, 26-29, and 31-34, Appellants argue that
these claims are separately patentable because the Wong patents do not
suggest an implant “structured to be placed in the anterior chamber of the
eye” (Appeal Br. 10-11).
This argument is not persuasive. First, the anterior placement
limitation is included only in claims 16 and 27, not claims 23, 26, 28, 29, or
31-34. Since claims 16, 23, 26-29, and 31-34 were argued together,
therefore, Appellants’ argument does not establish their common, separate
patentability. See 37 C.F.R. § 41.37(c)(1)(vii) (“When multiple claims
subject to the same rejection are argued as a group by appellant, the Board
may select a single claim from the group of claims that are argued together
to decide the appeal with respect to th[at] group of claims.”).
In any event, the Specification does not define any particular structure
that is required to make an implant suitable for placement into the anterior
chamber of the eye. Wong ‘116 and Wong ‘188 disclose implants for
placement in the eye, and Appellants have not pointed to any feature of the
implants disclosed by Wong ‘116 and Wong ‘188 that would make them
unsuitable for placement in the anterior chamber of the eye.
Finally, Appellants argue that results in the Specification show that
implanting a timolol maleate implant into the anterior chamber of the eye
showed greater effect in reducing intraocular pressure than implantation into
either the posterior segment or the conjunctiva (Appeal Br. 10), and that this
result was surprising (id.).
This argument is also not persuasive. Appellants have pointed to no
evidence of record to establish that the results cited by Appellants were
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unexpected. Attorney argument is not evidence. See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have made it obvious to make the products of claims
1 and 16 with a reasonable expectation of success.
SUMMARY
We affirm the rejection claims 1, 5-7, 10-18, 23, 26-29 and 31-34
under 35 U.S.C. § 103(a).
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).

AFFIRMED

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