Ex Parte Nelson

Patent Trial and Appeal Board

Jan 16, 2013

10234070 (P.T.A.B. Jan. 16, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KRISTOFF NELSON
__________

Appeal 2012-000239
Application 10/234,070
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
stent/graft delivery system. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses “a stent/graft composite prosthesis and a
deployment device” (Spec. 4). Figure 1 of the Specification is shown below:
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Figure 1 shows “a stent/graft composite prosthesis 14 and a stent retaining
device 5” (Spec. 6). The prosthesis 14 includes graft 4 and stent 2 (id.). The
Specification discloses that the “deployment device 5 … includes an
elongated outer sheath 6 which supports the prosthesis 14 in a compressed
condition” (id. at 8), as well as “a stent retaining member in the form of a
nose cap 8, which supports extending portion 2a of stent 2 in [a] compressed
condition within outer sheath 6” (id.).
The Specification states that the stent/graft is deployed by retracting
outer sheath 6 to allow stent 2 and graft 4 to expand, while “nose cap 8 holds
the proximal [sic, distal?] end of the stent 2 so it can be repositioned” (id. at
9). The nose cap 8 can then be advanced away from the stent, allowing stent
portion 2a to expand, after which the nose cap can be retrieved through the
lumen of the expanded stent/graft (see id. at 10).
Claims 1-9, 11, 12, and 51-53 are on appeal. Claim 1 and 51 are
representative and read as follows:
1. A prosthesis delivery system comprising:
a stent/graft composite prosthesis comprising a radially expandable
stent having opposed proximal and distal stent ends and a stent body
therebetween, and an elongated graft extending from said distal stent end;
and
a deployment device comprising:
an elongated outer sheath, the outer sheath overlying the graft
and said distal stent end of said prosthesis, the outer sheath maintaining said
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overlayed portions of said prosthesis in a radially compressed state, said
outer sheath being retractable with respect to said graft for allowing radial
expansion of said graft and said distal stent end; and
a stent retaining member, the stent retaining member overlying
and engaging said proximal stent end, the stent retaining member
maintaining said proximal stent end in a radially compressed state
independent of the outer sheath, said proximal stent end is positionable
within said stent retaining member, said retaining member being
independently removable from said proximal stent end for allowing radial
expansion of said proximal stent end independent from the expansion of said
distal stent end, wherein said stent retaining member is positionable within
said elongated outer sheath and wherein said stent retaining member is
retractable in the opposite direction of retraction of said outer sheath.

51. A delivery system comprising:
a retaining device, the retaining device comprising a first retaining
member and a second retaining member;
a prosthesis, the prosthesis comprising a first end region and a second
end region, the first end region being a stent and a second end region being a
graft, the prosthesis having a first state and a second state;
in the first state the stent has a reduced diameter and the graft
has a reduced diameter wherein the first retaining member surrounds a first
portion of the stent and maintains at least the first portion of the stent in the
reduced diameter and the second retaining member surrounds a second
portion of the stent and the graft and maintains the second portion of the
stent and the graft in a reduced diameter; and
in the second state the first portion of the stent has a reduced
diameter and the second portion of the stent and the graft have an expanded
diameter which is greater than the reduced diameter, wherein the first
retaining member surrounds the first portion of the stent and maintains the
first portion of the stent in a reduced diameter, the second retaining member
does not overlay the prosthesis, and no portion of the second end region of
the prosthesis is surrounded by any portion of the retaining device.

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The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• Claims 1-7, 11, and 12 in view of Ryan
1
and Brown;
2

• Claim 8 in view of Ryan, Brown, and Ravenscroft;
3

• Claim 9 in view of Ryan, Brown, and Roberts;
4
and
• Claims 51-53 in view of Ravenscroft and Brown.
I.
The Examiner has rejected claims 1-7, 11, and 12 under 35 U.S.C.
§ 103(a) as obvious in view of Ryan and Brown. The Examiner has also
rejected claims 8 and 9 as obvious in view of Ryan and Brown, combined
with Ravenscroft or Roberts, respectively. Since the same issue is
dispositive for all of these rejections, we will consider them together.
The Examiner finds that Ryan discloses “a prosthesis delivery system
comprising a catheter 10, self or balloon expandable stent 24, slidable sheath
retaining member 92 … and [a] proximal stent end retaining member 40 that
is [sic] moves independent from and in opposite direction of the sheath”
(Answer 5). The Examiner finds that Ryan does not disclose “delivering an
implant comprising a stent extending from a graft” (id. at 6), but that Brown
discloses such an implant (id.). The Examiner concludes that it would have
been obvious to use Ryan‟s device “to deliver the device of Brown in order
to reduce the implant[‟]s profile while … permitting it to be placed within
more areas of patient‟s vascular” (id.).

1
Ryan et al., US 5,108,416, issued Apr. 28, 1992.
2
Brown et al., US 5,769,887, issued June 23, 1998.
3
Ravenscroft et al., US 5,480,423, issued Jan. 2, 1996.
4
Roberts et al., US 5,984,964, issued Nov. 16, 1999.
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Appellant contends that the cited references would not have made
obvious a prosthesis delivery system in which the “stent retaining member is
retractable in the opposite direction of retraction of said outer sheath,” as
required by claim 1, because Ryan‟s “sheath 92 and end cap 26 are retracted
in the same direction” (Appeal Br. 11-12).
We agree with Appellant that the Examiner has not adequately shown
that the cited references would have made obvious the prosthesis delivery
system of claim 1. Ryan discloses a “system for introducing a stent …
[which] comprises a balloon catheter having a stent surrounding the balloon
portion of the catheter” (Ryan, abstract). Figure 4 of Ryan is shown below:

Figure 4 shows “a multi lumen catheter shaft 12, having a balloon 20
(concealed), mounted at the distal end of the shaft.… A stent 24 …
surrounds the balloon and is retained in position by end caps 26, 28 which
receive and capture the proximal and distal ends of the stent” (id. at col. 5,
ll. 24-26, 39-42). Ryan discloses that inflation of the balloon 20 causes
radial expansion of the stent 24 and “also causes end caps 26, 28 to be urged
radially and axially away, in umbrella-like fashion from the center of the
balloon, so that they retract and release the stent 24” (id. at col. 5, ll. 55-60).
Ryan discloses that “[o]nce the balloon 20 and end caps 26, 28 have returned
to their initial, non-retracted configuration, they have a cross-sectional
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diameter which is less than that of the interior diameter of the expanded
stent. The delivery catheter can then be withdrawn.” (Id. at col. 5, l. 67 to
col. 6, l. 3.)
Figure 14 of Ryan is shown below:

Figure 14 shows an “embodiment of the stent delivery system employing a
proximal end cap and a retractable sheath” (id. at col. 3, ll. 45-47). Ryan
discloses that the “distal end 96 of the sheath has a diameter large enough to
surround end cap 26 and the stent prior to stent expansion” (id. at col. 10, ll.
18-20). Ryan discloses that after the catheter distal end is positioned at the
desired location, the physician “slides the hub 94 toward the Y-fitting [22].
In so doing, the distal end of the sheath is withdrawn from the distal end of
the introducer, thereby exposing the stent.” (Id. at col. 10, ll. 24-29.)
Thus, the embodiment shown in Ryan‟s Figure 4 lacks an outer
sheath, as required by claim 1, and the embodiment shown in Ryan‟s Figure
14 includes a proximal end cap (26) (or “stent retaining member,” in claim
1), which is retracted in the same direction as the sheath. Even if the two
embodiments of Ryan‟s were combined, and included a distal end cap that
could be retracted in the opposite direction from the sheath, the Examiner
has not explained how such a system could be modified to contain a graft
extending from one end of the stent, as required by claim 1, if both ends of
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the stent are covered by end caps. Thus, we reverse the rejection of
independent claim 1 and dependent claims 2-7, 11, and 12.
We also reverse the rejections of claims 8 and 9 because these
rejections rely on the findings with respect to Ryan and Brown, as discussed
above, and the Examiner relies on Ravenscroft and Roberts only to show the
obviousness of limitations in dependent claims.
II.
The Examiner has rejected claims 51-53 as obvious in view of
Ravenscroft and Brown. The Examiner finds that Ravenscroft discloses “a
prosthesis delivery system comprising [a] prosthesis and first and second
retaining devices” (Answer 9). The Examiner finds that Ravenscroft‟s
system achieves the first and second states recited in claim 51 (id.) but
Ravenscroft does not disclose “an implant comprising a stent extending
from a graft” (id.).
The Examiner finds that “Brown discloses an implant comprising a
stent extending from a graft member” (id.). The Examiner concludes that it
would have been obvious to use Ravenscroft‟s system “to deliver the device
of Brown in order to reduce the implant[‟]s profile while retaining its
anchor” (id.).
Appellant contends that Ravenscroft does not disclose two retaining
members that surround portions of the stent, as required by claim 51 (Appeal
Br. 19). Appellant argues that the dictionary defines the word “surround” to
mean “to enclose on all sides; encompass” or “to form an enclosure round;
encircle” (id. at 18), while in Ravenscroft the relevant elements “do not
surround the distal end of the stent because the end members do not
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encircle, and are not positioned around the circumference of, the distal end
of the stent” (id. at 20).
We agree with Appellant that the Examiner has not adequately shown
that the cited references would have made obvious a delivery system with
first and second retaining members that each surrounds a portion of the stent.
Ravenscroft discloses “a system for positioning a prosthesis in contact with
tissue within a patient” (Ravenscroft, col. 1, ll. 47-48). Figure 2A of
Ravenscroft is shown below:

Figure 2a shows a catheter body “carrying a prosthesis 6, which is held in a
compact state for most of its length by a retractable restraining sheath 8. The
prosthesis 6 is a self-expanding knit-form stent having a series of end loops
10” (id. at col. 4, ll. 17-20).
Ravenscroft discloses that the catheter body “includes a series of
flexible elongate members 16” (id. at col. 4, ll. 20-22) and that “[o]ne end of
the members 16 is attached to the catheter body 4. The other, free end …
extends through the end loops 10, holding the end loops … in compact
form” (id. at col. 4, ll. 23-28). Ravenscroft discloses that the “end loops 10
of the prosthesis 6 can be released from the catheter body … by axially
withdrawing the catheter body 4 so the free ends 17 of the members 16 slip
back through the end loops 10” (id. at col. 4, ll. 29-35).
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The Examiner finds that the struts 16 and sheath 8 of Ravenscroft
correspond to the first and second retaining members of claim 51,
respectively (Answer 10). However, we agree with Appellant that one of
ordinary skill in the art would not interpret a first retaining member that
“surrounds a first portion of the stent” as encompassing the stent-retaining
struts 16 of Ravenscroft. The Specification does not provide an express
definition of “surrounds,” which is therefore given its ordinary and
customary meaning. See Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed.
Cir. 2005) (“[T]he words of a claim „are generally given their ordinary and
customary meaning.‟”). The Examiner does not dispute that “surrounds” has
the meaning of the dictionary definitions provided by Appellant, but argues
that the “nose cone struts of Ravenscroft comprise a plurality of strut
members that extend around the entire circumference of the catheter. The
struts are separated by gaps, but all of the struts combined surround a portion
of the stent.” (Answer 12.)
We disagree. As best shown in Ravenscroft‟s Figures 2b-2e (see also
id. at col. 4, ll. 15-35), the struts 16 of Ravenscroft‟s device lie inside of the
stent except for the free ends that extend through the stent‟s end loops 10.
Since the elongated struts of Ravenscroft do not circumscribe the exterior of
the stent, they do not “enclose [it] on all sides; encompass” or “form an
enclosure round; encircle” the stent (cf. Appeal Br. 18). Therefore, they do
not “surround” a portion of the stent according to the ordinary meaning of
the word. We reverse the rejection of independent claim 51 and dependent
claims 52 and 53 as being obvious in view of Ravenscroft and Brown.
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SUMMARY
We reverse the rejections of claims 1-9, 11, 12, and 51-53 under 35
U.S.C. § 103(a).

REVERSED

cdc