Ex Parte Kaplan

Board of Patent Appeals and Interferences

Apr 30, 2012

10852407 (B.P.A.I. Apr. 30, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/852,407 05/24/2004 Edward J. Kaplan KAP 100 CON 3109
23579 7590 04/30/2012
Pabst Patent Group LLP
1545 PEACHTREE STREET NE
SUITE 320
ATLANTA, GA 30309
EXAMINER
PERREIRA, MELISSA JEAN
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
04/30/2012 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 EDWARD J. KAPLAN
____________

Appeal 2010-010368
Application 10/852,407
Technology Center 1600
____________

Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 by the Patent
Applicant from the Patent Examiner’s rejections of claims 61-66 and 68-73.
The Board’s jurisdiction for this appeal is under 35 U.S.C. §§ 6(b) and 134.
We affirm.

STATEMENT OF THE CASE
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The claims are directed to a “non-radioactive completely
biodegradable polymeric radiopaque brachytherapy seed.” The claimed
seeds “can be sized and shaped to fit through the bore of a brachytherapy
implantation needle” for implantation into a target tissue (Spec. 4:13-15).
The seeds comprise a therapeutic agent to achieve “higher and more
consistent concentrations of a therapeutically active substance to a target
tissue.” (Spec. 5:10-11.)
Claims 61-66 and 68-73 are rejected and on appeal (App. Br. 2). All
the claims stand rejected by the Examiner as follows:
1. Claims 61-66 and 68-73 under 35 U.S.C. § 103(a) as obvious in
view of Zamora,1 Moroni,2 Wada,3 and Doiron4 (Answer 3); and
2. Claims 61-66 and 68-72 on the ground of nonstatutory
obviousness-type double patenting as unpatentable over claims 1-12 of U.S.
Patent No. 6,746,661 B2 (Answer 7).
Claims 61 is representative and reads as follows:
61. A non-radioactive completely biodegradable polymeric
radiopaque brachytherapy seed, wherein the seed has a
cylindrical shape with a diameter of at least 0.5 millimeters and
wherein the seed has a size and shape suitable for passing
through the bore of a needle having an interior diameter of less
than about 2.7 millimeters (10 gauge), comprising a
therapeutically effective amount of a therapeutic agent
dispersed within the polymer and released over a period of
weeks to months to cause a medically beneficial effect.
Claim 61

1 U.S. Patent No. 6,575,888 B2, issued June 10, 2003.
2 U.S. Patent No. 6,426,145 B1, issued July 30, 2002.
3 Wada et al., Pharmaceutical Research, 8(10), 1292-1296 (1991).
4 Doiron et al., Cancer Research, 59, 3677-3681 (1999).

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Claim 61 is directed to a (1) brachytherapy seed. The seed has the
following characteristics:
(2) “non-radioactive”
(3) “completely biodegradable polymeric”
(4) “radiopaque”
(5) “cylindrical shape with a diameter of at least 0.5 millimeters”
(6) “seed has a size and shape suitable for passing through the bore of
a needle having an interior diameter of less than about 2.7 millimeters (10
gauge)”
(7) “a therapeutically effective amount of a therapeutic agent
dispersed within the polymer and released over a period of weeks to months
to cause a medically beneficial effect.”

OBVIOUSNESS UNDER SECTION 103
The rejection
The Examiner found that Zamora described a brachytherapy seed
comprising the following materials, corresponding to the claimed
characteristics enumerated above: (3) a biodegradable polymer, (4)
radiopaque, and (7) a therapeutic agent (Answer 4). The Examiner
acknowledged that Zamora’s device comprised a radioactive material, and
was not (2) non-radioactive as required by the claim (see above), but the
Examiner cited Wada and Doiron as teaching that radioactive material is not
necessary to treat cancer, making it obvious to omit the material from
Zamora’s device (Answer 5). With regard to the shape and size of the
claimed seed, the Examiner found that Zamora described cylindrical tubes
with a diameter larger than what is claimed, but found that Doiron taught
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seeds within the claimed ranges of (5) and (6) (Answer 5 & 16). With
regard to the dispersion of the therapeutic agent in the biodegradable
polymer, and the particular recited release characteristics (7), the Examiner
relied on the combination of Zamora, Wada, and Doiron to meet this
limitation.
Issues
The issues in this rejection are whether the Examiner established, by a
preponderance of the evidence, that the skilled worker had sufficient reason
[1] to have omitted radioactivity from Zamora’s seed; [2] to have produced
seeds with the claimed sizes; and [3] to have made a seed comprising “a
therapeutically effective amount of a therapeutic agent dispersed within the
[biodegradable] polymer and released over a period of weeks to months to
cause a medically beneficial effect.”
Analysis
• Zamora teaches away from nonradioactive seeds and polymers with short
degradation times
Appellant contends that Zamora “teaches away from the claimed
seeds by requiring a radionuclide and requiring the polymer to have
sufficient persistence to keep the radionuclide sequestered.” (App. Br. 10.)
Appellant cites a report by Zamora which described problems with moving
from non-biodegradable materials to biodegradable materials (App. Br. 10).
Appellant also contends that Zamora is concerned with polymeric materials
that have sufficient permanence to contain the radioactive source, and which
would not be suitable for releasing a therapeutic material (Reply Br. 5).
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These arguments are not persuasive. Zamora describes release of a
therapeutic drug from a bioabsorbable polymer, the same feature recited in
(7) of claim 61. In particular, Zamora teaches:
The device may further include an effective amount of a
therapeutic drug which . . . may be disposed within at least a
portion of the structure of the bioabsorbable polymeric housing,
such as a tube. . . . The device may also include one or more
coating constituents admixed with the therapeutic drug, which
may assist in adhering the therapeutic drug to the device,
control the rate of release of the therapeutic drug or provide
similar functions.
(Zamora, col. 4, l. 46-58 (emphasis added).) Thus, Appellant’s contention
that Zamora does not teach a therapeutic agent that is releasably dispersed in
the seed polymer (Reply Br. 10) is without factual support.
It is true that Zamora teaches polylactide and polycaprolactone
polymers which have degradation kinetics in excess of 12-16 months
(Zamora, col. 8, ll. 32-34). However, Appellant has not explained how these
degradation kinetics are incompatible with the claimed limitation of (7) “a
therapeutically effective amount of a therapeutic agent dispersed within the
polymer and released over a period of weeks to months to cause a medically
beneficial effect,” as the claim expressly permits release over “months.”
Moreover, Zamora also teaches that the degradation profile can be
modified by the use of copolymers (Zamora, col. 8, l. 34). Table 1 of
Zamora lists “absorbable polymers” with degradation times from 1-12
months, which are also within the scope of the claimed ranges (7) (Zamora,
col. 8, ll. 50-61).
Furthermore, Zamora teaches that the drug delivery component, in
combination with the bioabsorbable structure, can be adjusted to predefined
release rates (Zamora, col. 13, ll. 1-16). Thus, Appellant’s arguments about
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the relative permanence of the polymer conflicting with the release of a drug
is inconsistent with the express disclosure in Zamora of polymers which
release a therapeutic drug over a 1-12 month period and Zamora’s teaching
that its polymers can be used to release a therapeutic drug (Zamora, col. 4, l.
46-58 (quoted above)).
Based on the teachings in Zamora, a person of ordinary skill in the art
would have recognized that a bioabsorbable polymer could be selected to
achieve a desired predefined release rates. Consistent with this teaching, the
Examiner relied upon Wada as teaching sustained released of drugs from
biodegradable polymers which show considerable degradation after a month
and polymer concentrations which enhance degradation (Answer 5 & 13).
Doiron also describes a biodegradable copolymer implant (Answer 5).
Appellant did not demonstrate a deficiency in the Examiner’s fact-finding.
Thus, the preponderance of the evidence supports the Examiner’s
determination that it would have been obvious to have made a brachytherapy
seed having (7) “a therapeutically effective amount of a therapeutic agent
dispersed within the polymer and released over a period of weeks to months
to cause a medically beneficial effect.”
Appellant points to differences in the degradation kinetics between the
polymers of Doiron and Zamora, concluding that it would not have been
obvious to combine their teachings (App. Br. 16). However, this argument
ignores the explicit teaching in Zamora of polymers of Table 1 within the
scope of the claims and with similar degradation rates to those of Doiron.
Appellant makes numerous arguments about the drug release rates of the
prior art, but the claims recite a release period of “period of weeks to months
to cause a medically beneficial effect” which covers periods as short as 15
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days (two weeks) or as long as six months that Appellant attempts to
distinguish his claims from (Reply Br. 11-12).
While it is true that Zamora describes a seed with a radionuclide, each
of Wada (Abstract, 1292) and Doiron (Abstract, 3677) describe implantable
medical devices with therapeutic drugs which lack a radionuclide. Thus, it
was recognized in the art that it was optional to include a radionuclide in an
implantable device, for example, for the treatment of cancer as taught by
Wada (Wada 1292, cols. 1-2).
Appellant contends that both Zamora and Doiron require radiation
(App. Br. 15-16). However, Wada expressly teaches compositions for
sustained release of drugs, including cancer drugs, without expressly
disclosing that radiation is necessary (Wada 1292, Abstract). Thus,
Appellant’s position -- that the fact that Zamora and Doiron require radiation
is a teaching away from a seed that lacks it -- is not supported by the
preponderance of the evidence. It is evident from the prior art – Zamora,
Wada, and Doiron – that using a biodegradable material to achieve sustained
release of a therapeutic agent was known in the prior art, in the same manner
as claimed here. The fact that certain uses may have involved radiation does
not negate the clear teaching in the prior art of non-radioactive drug
delivery, by itself, using biodegradable polymers (Wada 1292, col. 1,
“Introduction”; Doiron 3677, col. 2).

• Admixed with radiopaque material
Appellant contends that Zamora “teaches away from a seed containing
a therapeutic agent admixed with a radiopaque material, let alone admixed
with a biodegradable radiopaque material.” (App. Br. 11.)
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It appears that Appellant is attempting to distinguish the prior art
based on a limitation that does not appear in the claim. Claim 61 recites that
the therapeutic agent is “is dispersed within the polymer,” but does not recite
that the therapeutic agent is admixed with a radiopaque material.
Nonetheless, as found by the Examiner (Answer 4), Zamora teaches
that a coating may be employed which includes a radiopaque medium (col.
12, ll. 40-42; col. 12, ll. 64) and a “coating constituent” can be “admixed
with the effective amount of the therapeutic drug” (col. 15, claim 11; col. 16,
claim 27), which together disclose or reasonably suggest a coating with a
therapeutic agent and a radiopaque material.
Moreover, Moroni teaches that the radiopaque material can be applied
as a coating or may become part of the polymer matrix used to form the
implantable device (Moroni, col. 3, ll. 1-5), providing evidence that it was
within the scope of ordinary skill in the art to utilize the radiopaque in any
desired part of the implantable device in order to visualize it.
Appellant contends that Moroni describes biostable, non-degradable
coatings (App. Br. 12-13). However, this disclosure in Moroni is offset by
the other disclosure in the Moroni of bioabsorbable/biodegradable
radiopaque compositions (Moroni, Abstract & col. 6, claims 5 and 13).
Thus, we do not find Appellant’s argument persuasive about Moroni being
non-analogous prior art (Reply Br. 7) because Moroni expressly describes an
implantable medical device with the same materials as claimed.
We are also not persuaded by Appellant’s arguments about lack of
teaching of non-radioactive seed implants and dosages of drugs on such
implants in view of the express teaching in Wada of implantable no-
radioactive sustained release formulations (Wada 1292, col. 1,
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“Introduction,” col. 1, 1; col. 2 (“Cisplatin is a potent anticancer agent, but
highly toxic with a narrow therapeutic range. Thus, the sustained local
release of this drug from the polymeric device implanted near a tumor site
may minimize its side effects. “)

• Seed shape
Claim 61 is directed to a seed with a cylindrical shape. Appellant
contends that Wada is directed to films, and only mentions rods (cylindrical
shape) once in its introduction (App. Br. 14). Appellant states:
As discussed above, in Bausch & Lomb, Inc. v. Barnes-
Hind/Hydrocurve, Inc. (1986), the Federal Circuit held that a
single line in a prior art reference should not be taken out of
context and relied upon with the benefit of hindsight to show
obviousness. Rather, a reference should be considered as a
whole, and portions arguing against or teaching away from the
claimed invention must be considered.
(App. Br. 14).
Appellant also points to an email between the inventor and an author
of Wada stating:
[w]e undertook our investigation because we believed at the
time that the soft, flexible, biodegradable elastomeric drug-
carrier films possessed characteristic advantages over rigid
polymer seeds and needles, such that one would replace rigid
seeds with films when applying sustained-release technology to
the implantation of drugs near tumors.
(App. Br. 14).
As acknowledged by Appellant, Wada discloses rods and thus
expressly teaches an embodiment which meets the claimed shape limitation
(5). Even if films were considered superior for certain uses, the fact that
other known sustained release biodegradable forms were viewed as
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unpreferred or inferior does not constitute a teaching away. A teaching that
a result would be inferior or less desirable is not a teaching away unless the
use “would render the result inoperable.” In re ICON Health and Fitness
Inc., 496 F.3d 1374, 1381 (Fed. Cir. 2007).

• Seed size
Claim 61 recites that the seed has a (5) “cylindrical shape with a
diameter of at least 0.5 millimeters” and (6) “a size and shape suitable for
passing through the bore of a needle having an interior diameter of less than
about 2.7 millimeters (10 gauge).” The Examiner relied upon Doiron for its
teaching of seeds with the claimed size limitations.
Appellant contends that Zamora’s seeds are larger than those of
Doiron and dissimilar (App. Br. 16) and that the Examiner did not provide
evidence that Doiron’s rods could be implanted through the bore of a needle
(App. Br. 17). However, as found by the Examiner, the claims are not
method claims and do not require that the seeds to be implanted via needle
bore; the only requirement is that the seeds are of a size that could pass
through the bore (Answer 17). Appellant did not contest the Examiner’s
finding that Doiron’s rods have a size that falls within the scope of the claim
(Answer 17). As the size meets this criteria, we conclude that the Examiner
met the burden of showing that the claim limitation was met.

• Zamora is non-analogous art
Appellant contends that Zamora is non-analogous art because
“Zamora is concerned with permanence of biodegradable materials to
contain radioactive materials, ideally without any leakage or leaching of the
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radionuclide, while the claimed seeds are concerned with materials which
degrade in such a way to release an effective amount of a therapeutic agent
for weeks to months.” (Reply Br. 4-5).
This argument is not persuasive. Even when prior art is not in the
same endeavor as the claimed invention, it is still analogous prior art if it is
“reasonably pertinent to the particular problem with which the inventor is
involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). “A reference
is reasonably pertinent if, even though it may be in a different field from that
of the inventor's endeavor, it is one which, because of the matter with which
it deals, logically would have commended itself to an inventor's attention in
considering his problem.” In re Clay, 966 F.2d at 659,660 (Fed. Cir. 1992).
In this case, both Zamora and the claimed invention involve delivery
of therapeutic agents through implantable devices using biodegradable
polymers, and thus would be considered reasonably pertinent to the claimed
invention, despite the lack of radioactivity in the claimed device. As both
devices use the same principles – a biodegradable polymer to release
therapeutic agent – the skilled worker would have looked to Zamora when
making the claimed invention, despite the difference in the active agent, i.e.,
a radioactive agent and therapeutic agent in Zamora, but only a therapeutic
agent in the claimed invention.

• Claims 66, 68, and 72
Appellant contends that claim 66 is separately patentable, but invokes
the same argument as for claim 61 (App. Br. 17-18). Thus, for the reasons
already discussed, we do not find these arguments persuasive.
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Claim 68 depends on claim 61 and specifies that the brachytherapy
seed further comprises one or more pores. Appellant contends that Zamora,
Doiron, Wada and Moroni do not “disclose a porous brachytherapy seed,
which, as disclosed in the specification at least at page 13, lines 14-17, has
an increased surface area exposed to the target tissue.” (App. Br. 18.)
We do not agree. Moroni describes porous implantable devices for
use as vascular implants (Moroni, col. 1, ll. 35-36), making it obvious to
have made such a porous implant for that purpose. Moreover, as found by
the Examiner, the polymers disclosed in the prior art are the same as those as
those encompassed by the claims and therefore would be expected to have
the same porosity (Answer 28).
Claim 72 depends from claim 61 and specifies that the brachytherapy
seed is formed of a biodegradable radiopaque polymer. Appellant contends
that “[n]one of the art cited by the Examiner, alone or in combination,
discloses or suggests a non-radioactive brachytherapy seed formed of a
biodegradable radiopaque polymer.” (App. Br. 18). This argument is not
persuasive. As already discussed, Moroni describes bioabsorbable/
biodegradable radiopaque compositions (Moroni, Abstract & col. 6, claims 5
and 13).

• Secondary considerations
Appellant contends the claimed invention is non-obvious because,
inter alia, the “claimed seeds have a unique built-in ability to ‘shadow’ the
therapeutic agents released by the seed as they are distributed throughout the
target tissue.” (App. Br. 19). Appellant also contends that the claimed seed
achieve metronomic dosing (App. Br. 20).
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We have considered these arguments but do not find them persuasive.
“For objective evidence to be accorded substantial weight, its proponent
must establish a nexus between the evidence and the merits of the claimed
invention.” In re GPAC, Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995). In this
case, Appellant has not established that the limitations recited in the claim
are responsible for the asserted benefits of the claimed invention. Moreover,
objective evidence has not been provided; only attorney arguments have
been made. Arguments of counsel cannot take the place of evidence lacking
in the record. Estee Lauder, Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed.
Cir. 1997).

Summary
We affirm the rejection of claims 61-66 and 68-73 under 35 U.S.C.
§ 103(a) as obvious in view of Zamora, Moroni, Wada, and Doiron.

OBVIOUSNESS TYPE DOUBLE PATENTING REJECTION
We summarily affirm the obvious-type double-patenting rejection for
the reasons given by the Examiner. Appellant did not present any arguments
to the contrary (App. Br. 21).

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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