Ex Parte Igaki

Board of Patent Appeals and Interferences

Mar 29, 2012

10220472 (B.P.A.I. Mar. 29, 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.
10/220,472 08/30/2002 Keiji Igaki IGA-005 5556
7590 03/29/2012
Rader Fishman & Grauer
Suite 501
1233 20th Street NW
Washington, DC 20036
EXAMINER
NGUYEN, TUAN VAN
ART UNIT PAPER NUMBER
3731
MAIL DATE DELIVERY MODE
03/29/2012 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 KEIJI IGAKI
__________

Appeal 2010-003267
Application 10/220,472
Technology Center 3700
__________

Before TONI R. SCHEINER, DONALD ADAMS, and ERICA A. FRANKLIN,
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, 3-11, 13, 14, and 24, directed to a stent holding member. The
claims have been rejected as anticipated and obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
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STATEMENT OF THE CASE
Claims 1, 3-11, 13, 14, and 24 are pending and on appeal; claims 2,
12, 15-23, and 25 have been canceled (App. Br. 3-4). Claim 1 is
representative of the subject matter on appeal:
1. A stent holding member used in a stent delivery system adapted to
introduce a stent of a cylindrical configuration, designed to be implanted in a
living body, to a desired site of implantation in a vessel thereof, the stent
member comprising:
a tubular holder formed of unitary elastic material, the tubular holder
being mounted to the outer peripheral surface of a balloon of said stent
delivery system prior to said stent being mounted to said tubular holder;
said tubular holder having a groove in its outer peripheral portion for
holding one or more supporting struts making up said stent, the groove being
arranged for embedding each of said struts at least partially in said groove to
hold the stent, said groove being formed to a width narrower than the outer
diameter of said struts when the tubular holder is in a contracted state; and
wherein said groove is arranged to have its opening end side expanded
by expansion of said tubular holder along the radial direction to release the
holding of the stent in the groove to enable the stent to be released from the
tubular holder.
The Examiner rejected the claims as follows:
Claims 1, 3, 6, 8, 9, 13, 14, and 24 under 35 U.S.C. § 102(b) as
anticipated by Yan (US 6,066,156, May 23, 2000);
Claims 4, 5, 7, 13, 14, and 24 under 35 U.S.C. § 103(a) as
unpatentable over Yan and Werneth (US 6,056,906, May 2, 2000);
Claims 10, 13, 14, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Yan and Stinson (EP 0 894 505 A2, February 3, 1999);
Claims 11, 13, 14, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Yan and Rowe (US 6,146,358, November 14, 2000);
Claims 1, 3, 4, 6, 8, 9, 13, 14, and 24 under 35 U.S.C. § 102(b) as
anticipated by Solar (US 6,254,608 B1, July 3, 2001);
Appeal 2010-003267
Application 10/220,472

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Claims 5, 7, 13, 14, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Solar and Werneth;
Claims 10, 13, 14, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Solar and Stinson; and
Claims 11, 13, 14, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Solar and Rowe.
REJECTIONS BASED ON YAN
Findings of Fact
1. Claim 1 represents the claimed stent delivery system in its
broadest aspect, and requires, in relevant part, “a tubular holder formed of
unitary elastic material” wherein the “tubular holder [has] a groove in its
outer peripheral portion for holding one or more supporting struts making up
said stent.”
2. Yan discloses a stent delivery catheter in which:
[A] stent having interstitial spaces between its struts is crimped
on to a catheter or a balloon portion of the catheter. Next, a
heat sensitive adhesive is at least partially filled in to the
interstitial spaces and bonds to the surface of the balloon or
catheter. Also, with the interstitial spaces at least partially filled
in, the stent profile is much smoother. The smoother profile
minimizes “fish scaling” of the stent as it is advanced through a
patient’s tortuous arteries.
(Yan, col. 5, ll. 1-11.)
3. Figure 3 of Yan depicts a stent delivery catheter “where the
adhesive is applied after the stent is mounted on the balloon” (Yan, col. 5, ll.
26-27). Figure 3 is reproduced below:
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Figure 3 “is a side elevational view . . . shown in cross-section, where
the adhesive is applied after the stent is mounted on the balloon.
4. The description of Figure 3 is as follows:
[S]tent 18 is first firmly crimped onto balloon 14 (or C-flex if it
is used), adhesive 16 is then applied in a conventional manner
so that the adhesive tends to fill the interstitial space or gaps 15
in between stent struts 17. By applying the adhesive after
crimping the stent onto the balloon, there is no adhesive
between the stent and balloon which should facilitate separation
of the stent from the inflated balloon.
(Yan, col. 6, l. 65 - col. 7, l. 7.)
Discussion
Claims 1, 3, 6, 8, 9, 13, 14, and 24 stand rejected as anticipated by
Yan. The Examiner focuses attention on Yan’s Figure 3 and finds that Yan
describes a stent holding member comprising an elastic tubular holder which
meets all the requirements of claim 1, including the requirement that the
tubular holder have a groove in its outer peripheral portion for holding the
supporting struts of a stent when the tubular holder is in a contracted state.
Specifically, the Examiner finds that Yan discloses a stent holding
member for a balloon expanding stent, where “[t]he stent 18 is first firmly
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crimped onto balloon 14 or to the C-flex sleeve, then a layer of adhesive 16
covers the stent such that the adhesive tends to fill the interstitial space or
gaps 15 in between stent struts 17” (Ans. 3). The Examiner finds that the
adhesive filling the interstitial spaces forms a tubular holder with a groove
for holding the struts of the stent when the tubular holder is in a contracted
state (id.).
We disagree with the Examiner’s finding that Yan’s infilling adhesive
forms a discrete elastic tubular holder with a groove in its peripheral surface
in which the stent struts are embedded. Yan teaches that there is no adhesive
between the struts and the balloon (FF4), and there is no indication that the
adhesive filling the stent gaps or interstices would be connected in a tubular
shape if the stent struts were removed.
The Examiner also rejected the remaining claims as unpatentable over
Yan in combination with Werneth, Stinson, or Rowe. All of the remaining
claims also require a tubular holder with a groove in its outer peripheral
portion for holding the supporting struts of a stent, and none of the
secondary references makes up for this deficiency in Yan.
REJECTIONS BASED ON SOLAR
Findings of Fact
5. Again, claim 1 represents the claimed invention in its broadest
aspect, and requires, in relevant part, “a tubular holder formed of unitary
elastic material, the tubular holder being mounted to the outer peripheral
surface of a balloon of said stent delivery system.” Thus, among other
things, the claimed stent delivery system requires both a balloon and a
tubular holder.
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6. Solar discloses a balloon delivery catheter in which the balloon
is “fabricated from a conformable material” (Solar, col. 3, l. 60).
7. According to Solar, “[t]he term conformable . . . refers to a
substance that is flowable or compressible such that a) the substance may be
indented when pressure is exerted upon it by . . . a radially compressed stent
and b) the . . . stent, can become nested within such indentation(s)” (Solar,
col. 3, l. 62 - col. 4, l. 1).
8. Solar’s “balloon may be completely fabricated from the
conformable material” (id. at col. 4, ll. 4-5), or “the conformable element
may comprise a coating of a conformable material which is applied to the
balloon” (id. at col. 4, ll. 58-60).
9. Figures 3, 4 and 5 of Solar are reproduced below:

Figure 3 is a cross-sectional view of Solar’s delivery catheter within
an anatomical passageway (Solar, col. 6, ll. 42-46).
Figure 4 is a transverse cross sectional view of Solar’s delivery
catheter, wherein “the balloon 14 is completely fabricated from the
conformable material, [thus] the stent 16 is at least partially embedded
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therein when radially compressed thereabout” (id. at col. 7, ll. 48-51). “[A]s
shown in FIG. 4, the stent 16 is only partially embedded within the balloon
14, [but] it will be recognized that the thickness of the balloon 14 may be
such that the stent 16 is completely embedded therein” (id. at col. 7, ll. 51-
54).
Figure 5 depicts an embodiment in which “the delivery catheter 10 . . .
[is] provided with a balloon 14a which, rather than being completely
fabricated from a conformable material, comprises an inner layer 18 which
is fabricated from a non-compliant material and an outer layer 20 which is
fabricated from a conformable material” (id. at col. 7, ll. 55-61).
Discussion
Claims 1, 3, 4, 6, 8, 9, 13, 14, and 24 stand rejected as anticipated by
Solar.
The Examiner finds that Solar discloses “a stent holding member
(Figs. 1, 4 and 5) comprising[ ] a tubular holder 14a formed of a unitary
elastic material such as silicone rubber and the holder is mountable to the
balloon 18. The tubular holder having permanent mechanically formed
grooves by crimping the stent onto the holder 14a” (Ans. 7).
However, as discussed above, the claimed stent delivery system
requires both a balloon and a tubular stent holder, wherein the tubular holder
is mounted to the outer peripheral surface of the balloon (FF5).
Solar’s Figure 4 depicts a stent partially embedded in a balloon
“completely fabricated from . . . conformable material” (Solar, col. 7, ll. 58-
59; FF9), while Figure 5 depicts a stent partially embedded in a balloon
“compris[ing] an inner layer 18 which is fabricated from a non-compliant
material and an outer layer 20 which is fabricated from a conformable
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material” (id. at col. 7, ll. 58-61; FF9). Neither embodiment relied on by the
Examiner has a discrete stent holder, as required by all the claims on appeal,
therefore, the Examiner has not provided an adequate factual basis to
establish that Solar anticipates the claimed invention.
The Examiner also rejected the remaining claims as unpatentable over
Solar in combination with Werneth, Stinson, or Rowe. All of the remaining
claims also require both a balloon and a tubular stent holder, and none of the
secondary references makes up for this deficiency in Solar.
SUMMARY
The anticipation and obviousness rejections of the claims based on
Yan are reversed.
The anticipation and obviousness rejections of the claims based on
Solar are reversed.

REVERSED

DM