Ex Parte Shanley

Board of Patent Appeals and Interferences

Aug 14, 2009

11273916 (B.P.A.I. Aug. 14, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JOHN F. SHANLEY
____________

Appeal 2008-005918
Application 11/273,916
Technology Center 3700
____________

Decided: August 14, 2009
____________

Before JENNIFER D. BAHR, JOHN C. KERINS, and MICHAEL W.
O’NEILL, Administrative Patent Judges.

O’NEILL, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
John F. Shanley (Appellant) seeks our review under 35 U.S.C. § 134
of the final rejection of claims 49-82. We have jurisdiction under 35 U.S.C.
§ 6(b) (2002).
Appeal 2008-005918
Application 11/273,916

2
The Invention
Appellant’s invention is to expandable medical devices, such as
stents. The stents incorporate hundreds of drug-delivery reservoirs (depots)
filled with a matrix of polymer (carrier) and drug (beneficial agent). The
stents of the invention utilize the Conor depot technology that provides the
ability to choose beneficial agents and carrier materials to provide
programmed release kinetics for the beneficial agents.
Release kinetics refers to the release of the beneficial agent at
different points in time. As shown in figures 11B, 15C, 16C, and 17B, these
graphs represent different release kinetics for respective embodiments
having combinations of beneficial agent, biodegradable carrier, and a barrier
layer. The slope at any given point along the curve represents the instant
rate at which the beneficial agent is being released to the surrounding tissue.
The steeper the slope, the greater the instantaneous beneficial agent delivery
rate. For example, viewing Fig. 16C, selecting three exemplary points along
the curve starting near the origin and progressing along the time axis (x-
axis), the slope at each point further from the origin is steeper than the
previous selected point. This indicates that the instantaneous beneficial
delivery rate is greater than the previous point. In this instance, the delivery
rate increases over time and the combination of beneficial agent and carrier
has a release kinetics that has an increasing agent release profile.
Claim 49 is illustrative of the subject matter of on appeal:
An expandable medical device comprising: a
plurality of struts interconnected to form a
substantially cylindrical device which is
expandable from a cylinder having a first diameter
to a cylinder having a second diameter; and a
beneficial agent and carrier affixed to the plurality
Appeal 2008-005918
Application 11/273,916

3
of struts and configured and arranged to control the
release kinetics of the beneficial agent to
surrounding tissue, wherein the release kinetics
include an increasing agent release profile.
Each of the independent claims, as well as their dependent claims,
involved in this appeal requires the beneficial agent to be released with
increasing agent release profile, see claims 49, 61, 67, and 73.
The Rejection
Appellant seeks review of the Examiner’s rejection of claims 49-82
under 35 U.S.C. § 102(e) as being anticipated by Scheerder (U.S. Pat. Pub.
2002/0007209 A1, published Jan. 17, 2002).

OPINION
The dispositive issue before us is whether Scheerder discloses a
beneficial agent and carrier that have a release kinetics that includes an
increasing beneficial agent release profile.
Scheerder discloses a stent having perforated or non-perforated holes.
A therapeutic agent fills the holes. Scheerder discloses the delivery rate of
the therapeutic agent is controlled by the selection of an appropriate
bioabsorbable or biostable polymer and by the ratio of therapeutic agent to
the polymer. (¶ 0152). While Scheerder discloses that the delivery rate is
controlled, Scheerder does not disclose that there is an increasing rate of
instantaneous delivery. Therefore, the Appellants have demonstrated error.

DECISION
The Examiner’s decision to reject the claims is

Appeal 2008-005918
Application 11/273,916

4
REVERSED

LV

PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003