Ex Parte Dolan et al

Board of Patent Appeals and Interferences

Jun 13, 2012

11760499 (B.P.A.I. Jun. 13, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARK DOLAN, SUSAN REA, and JOHN KANTOR
__________

Appeal 2011-004231
Application 11/760,499
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-12.
1
We have jurisdiction under 35 U.S.C.
§ 6(b).

1
Claims 13-15 and 28 are also pending, but stand withdrawn from
consideration (App. Br. 2).
Appeal 2011-004231
Application 11/760,499

2
STATEMENT OF THE CASE
The Specification teaches that the “invention relates generally to
implantable devices that are used for treating vascular conditions,” wherein
the device has “upstanding walls skived from the surface of the device to
deliver a larger amount of the drug and to control the elution rate” (Spec. 1,
¶ 1).
Figure 5b of the Specification is reproduced below:

Figure 5b illustrates a channel formed on the exterior surface of a stent that
includes a sidewall protruding from the surface, wherein the sidewall is bent
over the channel (id. at 4, ¶¶16-17). As shown in the Figure, first sidewall
62 protrudes above surface 70 (id. at 6, ¶6). The sidewall 62 includes a
perpendicular portion 65 and a parallel portion 66, wherein the parallel
portion extends from the perpendicular portion at an angle greater than about
90 degrees when measures relative to exterior surface 70 (id.).
Claim 1 is representative of the claims on appeal, and reads as
follows:
Appeal 2011-004231
Application 11/760,499

3
1. A drug eluting implantable device comprising:
an exterior surface on the device;
at least one recess formed in the exterior surface; and
at least one sidewall protruding from the exterior surface adjacent the
at least one recess defining a channel with the recess into which the drug
may be loaded, the sidewall including a perpendicular portion substantially
perpendicular to the exterior surface and the sidewall further including a
parallel portion extending from the perpendicular portion, the parallel
portion extending from the perpendicular portion at an angle greater than
about 90 degrees as measured with reference to the exterior surface.

The following grounds of rejection are before us for review:
Claims 1-12 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Wu
2
and Brown.
3

We reverse.

ANALYSIS
The Examiner finds that Wu teaches all of the limitations of claim 1
except for teaching that “the sidewall further including a parallel portion
extending from the perpendicular portion, the parallel portion extending
from the perpendicular portion at an angle greater than about 90 degrees as
measured with reference to the exterior surface” (Ans. 4).

2
Wu et al., US 6,254,632 B1, issued Jul. 3, 2001.
3
Brown et al., US 6,071,305, issued Jun. 6, 2000.
Appeal 2011-004231
Application 11/760,499

4
The Examiner relies on Brown Figure 3 as showing “a stent with a
sidewall further including a parallel portion extending from a perpendicular
portion, the parallel portion extending from the perpendicular portion at an
angle greater than about 90 degrees as measured with reference to the
exterior surface in the same field of endeavor for the purpose of controlling
the direction and rate of delivery of therapeutic agents” (id. at 4). The
Examiner concludes that it would have been obvious to the ordinary artisan
“to modify the protrusion of Wu to include the parallel portion of Brown, in
order to better retain what is placed inside the channel” (id.).
Wu teaches a stent with protruding structures provided on the surface
thereof, wherein the protruding structures may be used to secure a cover on a
stent or to deliver a therapeutic substance (Wu, col. 2, ll. 53-63). Wu
teaches that the “protruding structure can have a variety of shapes, including
a generally circular shape so that the protruding structure forms a crater, and
an elongated shape so that the protruding structure forms a groove” (id. at
col. 3, ll. 3-6). Wu teaches further that the therapeutic substance can be
covered by a polymeric layer, which reduces the release rate for a delayed or
sustained delivery (id. at col. 3, ll. 13-17).
Figure 3B of Wu, relied upon by the Examiner (Ans. 4), is reproduced
below:
Appeal 2011-004231
Application 11/760,499

5

Figure 3B is a perspective view of a portion of a stent that has a protruding
structure shaped as a groove (id. at col. 3, ll. 55-56).
Brown is drawn to a stent that includes a cavity or interior for
containing a biologically active agent which is directionally delivered to the
desired location, such as the wall of a blood vessel (Brown, col. 2, ll. 48-52).
Brown teaches that the stent includes an outer surface including a luminal
portion and a support portion, wherein a delivery means delivers the
biologically active substance from the cavity through only one of the luminal
portion and the support portion (Brown, col. 2, l. 66-col. 3, l. 6).
Figure 3 of Brown, relied upon by the Examiner (Ans. 4) is
reproduced below:
Appeal 2011-004231
Application 11/760,499

6

Figure 3 is a cross-sectional view of the device of Brown positioned in a
body lumen (Brown, col. 4, ll. 1-3).
According to Brown:
The embodiment of the present invention illustrated in
FIG. 3 directionally delivers the biologically active agent 23
into the interior of the body lumen, which may include a fluid,
gas, or other bodily substance. The delivery means, or the slit
opening 22 has a width as described above, and permits
directional delivery of the biologically active agent 23 from the
cavity 20 through only the luminal portion 18 of the outer
surface 16 of the elongated member 12'. The biologically
active agent 23 is not directionally delivered to the wall 26 of
the body lumen in the embodiment of the present invention
illustrated in FIG. 3. Thus, the present invention permits
directional delivery to a predetermined location, which in FIG.
3 is the interior of the body lumen or a luminal fluid located
Appeal 2011-004231
Application 11/760,499

7
therein, by providing at least one fluid opening in only a portion
of the circumference of the tubular member.

(Id. at col. 8, ll. 38-53.)
Appellants assert that Brown shows an opening in the curved exterior
of a stent that leads to a channel within the stent (App. Br. 4). Appellants
argue that if one were to modify Wu in view of Brown, one would obtain a
concave shaped recess (id. at 6). In response, the Examiner provides the
following annotated figure (Ans. 9):

According to the Examiner, arrow A points to a substantially perpendicular
side wall, arrow B points to the parallel portion of the side wall, and the
black line indicates the exterior of the stent (id. at 8).
Appellants further assert that the Examiner is “arbitrarily label[ing]
items of Brown contrary to how those items are described in Brown itself”
(Reply Br. 4). Appellants argue that in interpreting Brown as set forth
above, the Examiner has read the term “„exterior surface‟” out of the claim,
because “if any portion of a stent can „be considered‟ by the Examiner to be
Appeal 2011-004231
Application 11/760,499

8
the „exterior surface‟, then the term „exterior surface‟ becomes meaningless”
(id. at 5-6).
We conclude that Appellants have the better position. That is, we
conclude that the Examiner has not met the burden of establishing a prima
face case of obviousness. Brown does not teach a stent with a sidewall
further including a parallel portion extending from a perpendicular portion,
the parallel portion extending from the perpendicular portion at an angle
greater than about 90 degrees as measured with reference to the exterior
surface, as found by the Examiner; but, as argued by Appellants, instead
teaches a stent that includes a cavity. As such, we also agree with
Appellants that the Examiner has arbitrarily drawn a line in FIG. 3 of Brown
to define an external surface. Therefore, the Examiner has not provided
evidence or reasonable explanation as to why one would have modified the
protruding structure of Brown to obtain the claimed invention, based on the
teachings of Brown. That is, the Examiner has not explained why it would
have been obvious to modify the protruding structure of Wu, which is on the
external surface of a device, such as a stent, by adding a parallel portion
extending from a perpendicular portion, the parallel portion extending from
the perpendicular portion at an angle greater than about 90 degrees as
measured with reference to the exterior surface, based on the teachings of
the cavity of Brown, which is drawn to a device, such as a stent, that has a
cavity that communicates with the exterior surface through only one of the
luminal portion and the support portion. We thus reverse the rejection as to
claim 1 and the claims dependent thereon.
Appeal 2011-004231
Application 11/760,499

9
Claim 9, the other independent claim on appeal, also recites the
limitations that “the sidewall include[e] a perpendicular portion substantially
perpendicular to the exterior surface and the sidewall further including a
parallel portion extending from the perpendicular portion, the parallel
portion extending from the perpendicular portion at an angle greater than
about 90 degrees as measured with reference to the exterior surface.” We
thus reverse the rejection as to claim 9, as well as the claims dependent
thereon, for the reasons set forth with respect to claim 1.

REVERSED

alw