Ex Parte Doty

Board of Patent Appeals and Interferences

Dec 20, 2007

10302646 (B.P.A.I. Dec. 20, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DAVID R. DOTY
__________

Appeal 2007-4196
Application 10/302,646
Technology Center 3700
__________

Decided: December 20, 2007
__________

Before TONI R. SCHEINER, ERIC GRIMES, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 1-4 and
6-15. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
The claims are directed to a stent delivery system comprising a stent
compressed on an expandable balloon. The stent is mounted, at its proximal
and distal edges, between “retention bumps” affixed to the balloon which
reduce “longitudinal displacement” of the stent when being positioned in the
Appeal 2007-4196
Application 10/302,646

body. The issue in this appeal is whether the prior art suggests retention
bumps which are affixed to the balloon.
Claims 1-15 are pending; claim 5 is allowed (Final Rejection dated
Apr. 11, 2005); claims 1-4 and 6-15 are appealed (Answer 3). Appellant
requests review of the following rejections:
Claims 1-4, 6, 7, 11, 12, and 15 under 35 U.S.C. § 103(a) as obvious
over Alt (U.S. Pat. No. 6,027,510, Feb. 22, 2000) (Answer 3); and
Claims 8-10, 13, and 14 under 35 U.S.C. § 103(a) as obvious over Alt
in view of Jendersee (U.S. Pat. No. 5,836,965, Nov. 17, 1998) (Answer 4).
We select claims 1, 7, 8, and 15 as representative of the appealed
subject matter. Claims 1, 7, 8, and 15 read as follows:
1. A stent delivery system, comprising:
an inner member;
an expandable balloon mounted in a collapsed state on
said inner member,
a compressible stent mounted in a compressed state
around said expandable balloon, said compressible stent having
a proximal edge and a distal edge; and
at least first and second retention bumps affixed to said
balloon substantially adjacent said proximal edge and said
distal edge respectively for reducing longitudinal displacement
of said compressible stent.

7. A stent delivery system according to [claim 1 wherein the
bumps have a height at least equal to the thickness of the stent,
comprise first and second pluralities of retention bumps affixed
around the periphery of said expandable balloon substantially
adjacent said proximal edge and said distal edge respectively,
and the pluralities are substantially hemispherical in shape]
wherein each of said retention bumps is adhesively coupled to
said expandable balloon.

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Application 10/302,646

8. A stent delivery system according to claim 7 wherein each of
said pluralities of retention bumps is made of an elastomeric
material.

15. A stent delivery system, comprising:
an inner member;
an expandable balloon mounted in a collapsed state on
said inner member, said balloon having a peripheral surface;
a compressible stent mounted in a compressed state
around said expandable balloon, said compressible stent having
a proximal edge and a distal edge; and
first and second pluralities of substantially hemispherical
retention bumps affixed with approximate equal spacing around
the peripheral surface of said balloon substantially adjacent said
proximal edge and said distal edge respectively for reducing
longitudinal displacement of said compressible stent.

FINDINGS OF FACT
The Alt Patent
1. Alt teaches a stent delivery system comprising a balloon 12 attached to a
catheter 13 (Alt, at col. 4, ll. 60-66; Figs. 1, 4, and 5).
2. The catheter 13 has an inner lumen through which a guide wire 15
extends (Alt, at col. 4, ll. 65-67).
3. A stent 20 is mounted on the balloon membrane 12 for deployment at a
selected target site in the coronary artery (Alt, at col. 5, ll. 11-14; Figs. 1 and
5).
4. The “catheter 13 is fabricated with a pair of spaced-apart bumps or
projections 23 and 24 at the distal and proximal ends of the balloon 12, with
the spacing between the bumps . . . being made at least slightly greater than
the length of the stent 20 which is to be implanted, to accommodate the stent
therebetween” (Alt, at col. 5, ll. 27-33; Figs. 1-3 and 5).
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5. Fig. 5 of Alt shows the bumps adjacent to the proximal and distal edges
of the stent.
6. “The bumps may extend fully about the circumference of the catheter at
their locations proximal and distal of the balloon ends which is the preferred
embodiment as shown in FIGS. 1, 4 and 5, or may be interrupted by slots or
channels 25 as shown in the alternative embodiment of FIG. 2.” (Alt, at col.
5, ll. 33-40.) As shown in Fig. 2 of Alt, the bumps are equally spaced apart.
7. The “critical aspect of the bumps 23 and 24 is that they be sufficiently
sized and shaped to retain the stent 20 in place on the balloon 12 without
likelihood that the stent will be dislodged, while the delivery system is being
advanced to (or retracted from) the target site in the vessel” (Alt, at col. 5, ll.
48-52).
8. “While the balloon catheter 13 is preferably manufactured to have the
bumps 23 and 24 at each end of the balloon, by molding the catheter from
biocompatible material to include them, the bumps may instead be fabricated
separately of the same conventional material as the catheter, in any
conventional manner, and thereafter fixedly applied at those locations on the
stent by gluing them onto the surface of the catheter with a medical grade
adhesive” (Alt, at col. 6, ll. 4-11).
9. The preferred embodiments shown in Figs. 1, 2, 3, and 5 show the
retention bumps on the catheter body underlying the ends of the balloon
(App. Br. 5).
10. The phrase “at each end of the balloon” (Alt, at col. 6, l. 5; Findings of
Fact (“FF”) 8) reasonably suggests that the bumps can be placed on and at
the end of the balloon because such bumps would literally be at the end of
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the balloon and would be equivalent in function to bumps which are affixed
to the catheter body as shown in the preferred embodiments (FF 9).
11. The placement of the bumps on the balloon would have been recognized
by persons of skill in the art as suitable and equivalent to their position on
the catheter body as shown in Alt’s preferred embodiments.
Application of the Alt Patent to claims
12. Alt describes a stent delivery system which comprises an inner guide
wire 15 that meets the limitation of “an inner member” of the stent delivery
system of claim 1 (FF 2; Answer 3).
13. Alt’s stent delivery system also comprises a balloon 12 and stent 20
which correspond to the “expandable balloon” and “compressible stent” as
recited in claim 1 (FF 1, 3; Answer 3).
14. The stent delivery system of Alt comprises retention bumps 23 and 24
located “adjacent” to the proximal and distal edges of the stent (FF 4, 5) as
required by claim 1.
15. Alt describes spaced-apart bumps on a catheter to retain a stent (FF 4,
6), but Alt does not describe “first and second retention bumps affixed to”
the balloon as recited in claim 1.
16. The bumps described by Alt serve the same function) as the claimed
“affixed bumps”1 in retaining “the stent in place on the balloon” (Answer 3-
4 and 5).

1 We interpret “affix” to mean “to fasten, join, or attach.” The Random
House Dictionary 23 (1982). Thus, when the bumps are “affixed” to the
balloon, they are not an integral part of the balloon, but are directly attached
to the balloon membrane.
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Application 10/302,646

OBVIOUSNESS OVER ALT
Claims 1-4, 6, 7, 11, 12, and 15 stand rejected under 35 U.S.C. §
103(a) as obvious over Alt.
Alt describes a stent delivery system which comprises structural
elements that correspond to “an inner member”, “an expandable balloon”,
and “a compressible stent” of claim 1 (FF 12-13) with retention bumps
adjacent to the stent’s proximal and distal edges (FF 14). Alt does not
expressly describe “first and second retention bumps affixed to” the balloon
(FF 15) as recited in claim 1. Rather, Alt teaches retention bumps (“spaced-
apart bumps or projections 23 and 24”) which are “molded” or “fixedly
applied” to the catheter at the ends of the balloon (FF 4, 8, and 9). The issue
in this rejection is whether the Alt Patent would have reasonably suggested
to persons of ordinary skill in the art affixing the first and second retention
bumps to the balloon. In our opinion, as explained in more detail below, the
answer is yes.
Alt teaches spaced-apart bumps or projections on the catheter of a
stent delivery system which retain the stent in place on the balloon (FF 4) –
the same function served by the claimed retention bumps (FF 16). Alt states
that the “critical aspect of the bumps 23 and 24 is that they be sufficiently
sized and shaped to retain the stent 20 in place on the balloon 12 without
likelihood that the stent will be dislodged, while the delivery system is being
advanced to (or retracted from) the target site in the vessel” (Alt, at col. 5, ll.
48-52; FF 7). While there is no express statement in Alt that the bumps be
affixed to the balloon, we find that Alt’s teaching that the bumps be placed
“at each end of the balloon” (FF 8) reasonably suggests that the bumps can
be placed on and at the end of the balloon because such bumps would
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literally be at the end of the balloon and would be equivalent in function to
bumps which are affixed to the catheter body as shown in the preferred
embodiments (FF 10). The placement of the bumps on the balloon would
have been recognized by persons of skill in the art as suitable and equivalent
to their position on the catheter body as shown in Alt’s preferred
embodiments (FF 11). “[W]hen a patent ‘simply arranges old elements with
each performing the same function it had been known to perform’ and yields
no more than one would expect from such an arrangement, the combination
is obvious.” KSR Int'l v. Teleflex Inc., 127 S.Ct. 1727, 1740 (2007). Such
bumps are also shown in Fig. 2 of Alt to be equally spaced (FF 6), thus
meeting the limitation of claim 15 (see App. Br. 6).
Alt states that different methods of manufacturing can be used to
make the retention bumps, including molding the bumps on the catheter or
attaching them to a catheter using an adhesive (FF 8). Thus, persons of
ordinary skill in the art would have known that bumps could be affixed to
the balloon catheter using adhesives as recited in instant claim 7 (see App.
Br. 6).
Appellant argues that the Examiner incorrectly found that Alt’s
retention bumps are affixed to a balloon in a stent delivery system (Reply
Br. 2-3).
From Alt’s figures, such as Fig. 4, it appears – as argued by Appellant
– that the bumps are affixed to the part of the catheter which underlies the
balloon (App. Br. 5; FF 9). However, Alt at column 6, lines 4-5 states that
“the balloon catheter 13 is preferably manufactured to have the bumps 23
and 24 at each end of the balloon” (FF 8). We find, as discussed above, the
phrase “at each end of the balloon” reasonably suggests affixing the bump to
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the balloon itself (FF 10) since the phrase does not exclude attachment to the
balloon and because placement of the bumps on the balloon would have
been recognized by persons of skill in the art as suitable and equivalent to
their position on the catheter body as apparently shown in Alt’s preferred
embodiments (FF 11).
For the foregoing reasons, we affirm the rejections of claims 1, 7, and
15. Claims 2-4, 6, 11, and 12 fall with claims 1, 7, and 15 because separate
reasons for their patentability were not provided. See 37 C.F.R.
§ 41.37(c)(1)(vii).

OBVIOUSNESS OVER ALT AND JENDERSEE
Claims 8-10, 13, and 14 stand rejected under 35 U.S.C. § 103(a) as
obvious over Alt in view of Jendersee.
Appellant does not separately argue the claims in this rejection.
Consequently, we select claim 8 as representative, which limits the retention
bumps to being made of an elastomeric material. The Examiner finds that
Jendersee teaches a stent made of an elastomeric material (Answer 4). The
Examiner states that it
would have been obvious to one having ordinary skill in the art
at the time the invention was made to take the invention of Alt
and utilize the materials as taught by Jendersee et al. because
. . . [elastomeric material] is well know[n] in the art for its
properties during insertion and implantation . . . and applicant
has not disclosed that by using these materials solves any stated
problem, particular purpose or solution.
(Answer 4).
Appellant does not identify a deficiency in this rejection, and as we
find none, we affirm the rejection of claim 8. Claims 9, 10, 13, and 14 fall
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with claim 8 because separate reasons for their patentability were not
provided. See 37 C.F.R. § 41.37(c)(1)(vii).

TIME PERIOD
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

Ssc:

MEDTRONIC VASCULAR, INC.
IP LEGAL DEPARTMENT
3576 UNOCAL PLACE
SANTA ROSA, CA 95403
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