Ex Parte Weber

Board of Patent Appeals and Interferences

Jul 29, 2011

10928999 (B.P.A.I. Jul. 29, 2011)

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.
10/928,999 08/26/2004 Jan Weber 03-329 4437
27774 7590 07/29/2011
MAYER & WILLIAMS PC
251 NORTH AVENUE WEST
Suite 201
WESTFIELD, NJ 07090
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
07/29/2011 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 JAN WEBER
__________

Appeal 2010-008917
Application 10/928,999
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1 and 3-12, directed to a medical device. The claims have been
rejected on the grounds of obviousness and nonstatutory obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b).

Appeal 2010-008917
Application 10/928,999

2
STATEMENT OF THE CASE
The Specification teaches that:
[V]arious types of drug-coated stents have been used for
the localized delivery of drugs to the wall of a body lumen . . .
however, the hydrophobic or hydrophilic nature of drugs that
are used in the coating can impose a number of difficulties on
the design of drug delivery coating. For example, . . . [a]
hydrophobic drug will tend to cluster inside a hydrophilic
coating and as a result, will not be evenly distributed
throughout the coating. On the other hand, when using a
hydrophobic matrix that allows an even distribution of a
hydrophobic drug, it is difficult to get a 100% release of the
hydrophobic drug into a hydrophilic environment as the
hydrophobic drug will be more inclined to remain inside the
hydrophobic matrix environment.
Similarly, when using a block-polymer with both
hydrophobic and hydrophilic side-branches, one will get a self-
assembly of the alike structures whereby the hydrophobic drug
will be attached to the regions of the highest hydrophobicity
and therefore, making it difficult to release the hydrophobic
drug in an effective and consistent manner. . . .
. . .
In order to optimize drug-delivery, one has to solve the
contradiction of a hydrophobic drug that needs to act as
hydrophilic or vice versa.
(Spec. ¶¶ 4-7.)
According to the Specification, a hydrophobic drug can be made to
“act as hydrophilic” so that it is released from an implanted medical device
in a steady, consistent manner by encapsulating the drug in a multilayer
particle, where the particle has an inner hydrophobic layer and an outer
hydrophilic layer, and the particle is incorporated in a hydrophilic coating
disposed on the surface of the device. (Spec. ¶¶ 9-10.)

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Claim 1 is representative of the subject matter on appeal:
1. A medical device comprising a surface and a coating disposed on the
surface, wherein the coating comprises a first hydrophilic polymeric material
incorporating a plurality of particles, and wherein the particles comprise an
outer layer comprising a second hydrophilic polymeric material, an inner
layer comprising a hydrophobic polymeric material, and a core comprising a
hydrophobic therapeutic agent.

The claims stand rejected as follows:
Claims 1 and 3-11 under 35 U.S.C. § 103(a) as unpatentable over
Furst,
1
Ottoboni,
2
and Luo,
3
as evidenced by Burns
4
and McPherson
5
(Ans.
3-7);
claim 12 under 35 U.S.C. § 103(a) as unpatentable over Furst,
Ottoboni, Luo, and Davila,
6
as evidenced by Burns and McPherson (Ans.
12-13);
claims 1 and 3-12 “on the ground of nonstatutory obviousness-type
double patenting” over claims 1-40 of Application No. 11/701,768, in view
of Furst, Ottoboni, and Luo (Ans. 15-16).
7

We reverse.

1
Furst, US 2003/0040790 A1, February 27, 2003.
2
Ottoboni et al., US 6,193,951 B1, February 27, 2001.
3
Yi Luo & Glenn D. Prestwich, Novel Biomaterials for Drug Delivery, 11
Expert Opin. Ther. Patents 1395-1410 (2001).
4
Burns et al., US 6,294,202 B1, September 25, 2001.
5
McPherson et al., US 6,013,855, January 11, 2000.
6
Davila et al., US 7,056,550 B2, June 6, 2006.
7
A second rejection of claims 1 and 3-12 on the ground of obviousness-
type double patenting over the claims of Application No. 10/857,723 is moot
as the Application has been abandoned.
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Application 10/928,999

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OBVIOUSNESS
The Examiner finds that Furst discloses stents “that are at least
partially coated and/or impregnated with one or more biologically active
agent[s] (e.g., Taxol = paclitaxel)” (Ans. 4). According to the Examiner,
Furst discloses “an embodiment wherein the biologically active agent . . . is
at least partially encapsulated in a biodegradable polymer” (id.), and also
teaches that “the encapsulated biologically active agent can be encapsulated
with different numbers of coating layers” (id.). The Examiner acknowledges
that Furst doesn‟t disclose coatings containing multi-layer particles of the
active agent.
However, the Examiner finds that Ottoboni discloses “polymeric
microparticles comprising a shell having an outer layer of a biologically
compatible material and an inner layer of biodegradable polymer wherein
the core of said particles contain a liquid or solid for use in drug delivery”
(id. at 5). In addition, the Examiner finds that Luo teaches that “the safety
and efficacy of pharmaceutical agents can be greatly improved by
encapsulation within a biomaterial” (id. ).
The Examiner concludes that it would have been obvious
to utilize a plurality of particles, wherein said particles comprise
a core, an inner layer, and an outer layer, and wherein said core
comprises paclitaxel,
[8]
said inner layer comprises a
hydrophobic polymer, and said outer layer comprising a
hydrophilic polymer as taught by Ottoboni for coating a stent as
taught by Furst. One would have been motivated to incorporate
the particles of Ottoboni into the hydrophilic coating of Furst
since Furst suggests that biologically active agents may be
encapsulated in the biodegradable polymer to control the

8
Paclitaxel is a hydrophobic therapeutic agent (Spec. ¶ 102).
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Application 10/928,999

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release characteristic of the biologically active agent, and
Ottoboni teaches particles that may be filled with drug to
preferentially release at the target site.
(Id. at 6.)
Appellant contends essentially that the proposed combination of Furst
and Ottoboni “is not supportable” in the first place because Furst “teaches a
medical device with a captive coating so that the polymer releases the
biological agent” (App. Br. 6), while Ottoboni “teaches microparticles that
are freely movable and capable of passing through the capillary systems of a
subject” (id.).
Moreover, Appellant contends that combining the references would
“not result in the present invention as claimed” (App. Br. 9), because
Ottoboni “gives no guidance regarding the selection of hydrophobic vs.
hydrophilic therapeutic agents as a core material” (id.); “teaches both
hydrophobic and hydrophilic polymers as inner layer materials with no
guidance concerning the selection of hydrophobic vs. hydrophilic polymers”
(id.); and “does not teach the use of hydrophilic polymers . . . for use as an
outer layer, rather . . . amphiphilic materials . . . are taught as shell
materials” (id.).
The issue with respect to both of the obviousness rejections is whether
the evidence of record supports the Examiner‟s conclusion that it would
have been obvious to coat a medical device with a layer comprising “a first
hydrophilic polymeric material incorporating a plurality of particles, and
wherein the particles comprise an outer layer comprising a second
hydrophilic polymeric material, an inner layer comprising a hydrophobic
polymeric material, and a core comprising a hydrophobic therapeutic agent.”

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Principles of Law
[An invention] composed of several elements is not proved
obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. . . . [I]t can be important
to identify a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in
the way the claimed new invention does.
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
Findings of Fact
1. Furst discloses an expandable stent, which may be “at least
partially coated and/or impregnated” with a biological agent (Furst ¶ 30),
which may in turn, be “at least partially encapsulated in [a] biodegradable
polymer and/or copolymer” (id. at ¶ 31).
2. Ottoboni discloses “microparticle contrast agents which are
delivered intravenously but are capable of passing through the pulmonary
circulation system” (Ottoboni, col. 1, ll. 60-62), and which may “also [be]
used for drug delivery where the drug is released from the particle by
diffusion from the microparticle, by degradation of the microparticle, or by
rupture of the particle using ultrasonic energy” (id. at col. 1, l. 67 to col. 2, l.
4).
3. Ottoboni‟s microparticles have “a bi-layered shell” (Ottoboni,
col. 2, l. 57), specifically “an outer layer comprising a biologically
compatible material and an inner layer comprising a biodegradable polymer”
with “a hollow core, containing either a gas or a liquid, or a solid core”
(Ottoboni, col. 2, ll. 11-14).
4. Ottoboni teaches that “[t]he outer shell which is exposed to the
blood and tissues . . . [is] made of a biocompatible material which is
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typically amphiphilic, that is, [it] has both hydrophobic and hydrophilic
characteristics” (Ottoboni, col. 3, ll. 9-14).
5. The inner shell is made of “a biodegradable polymer . . .
[which] provides additional mechanical or drug delivery properties to the
microparticle which are not provided or insufficiently provided by the outer
layer” (id. at col. 3, ll. 43-47). Ottoboni lists a number of “[t]ypical
biodegradable polymers,” including some which, according to the Examiner,
are hydrophobic (e.g., polycaprolactones and poly(ortho)esters) (id. at col. 3,
ll. 55-63). In keeping with the mechanical/structural role of the inner shell,
Ottoboni teaches that the biodegradable polymer may be “selected for its
modus of elasticity and elongation, which define the desired mechanical
properties” (id. at col. 3, ll. 53-55). Ottoboni does not discuss the polymers
in terms of their hydrophobicity or hydrophilicity.
6. Luo teaches that the “[s]afety and efficacy of pharmaceutical
agents can be greatly improved by encapsulation within, or covalent
attachment to, a biomaterial carrier” which “provides patterned release of the
active agent with a pre-determined time course” (Luo, Abstract).
Discussion
We agree with Appellant that the record does not support the
Examiner‟s conclusion that the claimed invention would have been obvious.
Even if we were to accept the Examiner‟s conclusion that it would have been
obvious to incorporate Ottoboni‟s multilayer particles in the coatings on
Furst‟s implantable medical devices, the Examiner still has not explained
how Ottoboni would have led one of ordinary skill in the art to assemble the
specific arrangement of hydrophobic and hydrophilic layers required by all
the claims on appeal.
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Application 10/928,999

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The rejection of claims 1 and 3-11 as unpatentable over Furst,
Ottoboni, and Luo is reversed, as is the rejection of claim 12 as unpatentable
over Furst, Ottoboni, Luo, and Davila.
DOUBLE PATENTING
The Examiner provisionally rejected claims 1 and 3-12 “on the ground
of nonstatutory obviousness-type double patenting” over claims 1-40 of co-
pending Application No. 11/701,768 in view of Furst, Ottoboni, and Luo
(Ans. 15).
According to the Examiner,
[C]laims 1-40 [of the „768 application] are directed to a medical
device comprising a substrate, a porous reservoir containing a
therapeutic agent disposed over the substrate, a nanoporous
layer disposed over the reservoir, and a plugged aperture
located within the substrate or the nanoporous layer, wherein
[the] medical device releases said therapeutic agent.
(Ans. 16.)
The Examiner acknowledges that the claims of the co-pending
application
do not recite a polymeric stent coating comprising a hydrophilic
polymeric material . . . incorporating a plurality of particles,
wherein said particles comprise an outer layer comprising a
second hydrophobic [sic, hydrophilic?] polymeric material, and
an inner layer comprising a hydrophilic [sic, hydrophobic?]
polymeric material, and a core comprising a hydrophilic [sic,
hydrophobic?] therapeutic agent.
(Ans. 16.)
However, the Examiner concludes that the claimed invention is
merely “an obvious variant” (id.) of the claims of the co-pending
application, given the teachings of Furst, Ottoboni, and Luo, for the same
reasons given above.
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Application 10/928,999

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Again, we find that the record does not support the Examiner‟s
conclusion, for at least the reasons discussed above in connection with the
Examiner‟s proposed combination of Furst, Ottoboni, and Luo.
The provisional rejection of claims 1 and 3-12 over claims 1-40 of co-
pending Application 11/701,768 is reversed.
SUMMARY
The rejections of claims 1 and 3-12 on the grounds of obviousness and
nonstatutory double patenting are reversed.

REVERSED

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