Ex Parte Abrams et al

Board of Patent Appeals and Interferences

Mar 22, 2012

11028808 (B.P.A.I. Mar. 22, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT M. ABRAMS and ELAINE LEE
__________

Appeal 2010-011834
Application 11/028,808
Technology Center 3700
__________

Before DONALD E. ADAMS, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a stent.
The Examiner rejected the claims as anticipated and obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

Appeal 2010-011834
Application 11/028,808

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Statement of the Case
The Claims
Claims 1-8, 10, and 43-46 are on appeal. Claim 1 is representative
and reads as follows:
1. A delivery system for delivering an expandable
medical device to a body location, the expandable
medical device having a reduced configuration and an
expanded configuration, the delivery system comprising:
a catheter, the catheter having a catheter shaft
having a proximal region and a distal region, the catheter
shaft defining a pull-wire lumen, at least a portion of the
distal region defining a medical device receiving region;
the expandable medical device disposed about the
medical device receiving region in the reduced
configuration, the expandable medical device further
having proximal and distal device ends;
at least one retractable retaining wire, at least a
portion of the at least one retractable retaining wire
wound about at least a portion of the expandable medical
device and retaining the expandable medical device in
the reduced configuration, one end of the at least one
retractable retaining wire terminating in at least one pull-
wire, the at least one pull-wire extending into the pull-
wire lumen to the proximal region of the catheter shaft;
and
a portion of the medical device receiving region
defining at least one lumen port, the at least one lumen
port positioned centrally in the medical device receiving
region, the at least one pull-wire extending proximally
from the proximal end of the at least one retractable
retaining wire and passing through the at least one lumen
port to enter into the pull-wire lumen.

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Application 11/028,808

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The issues

A. The Examiner rejected claims 1, 2, 5, 7, 8, and 10 under 35 U.S.C. §
102(b) as anticipated by Yee
1
(Ans. 4-5).
B. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a) as
obvious over Yee (Ans. 5-6).
C. The Examiner rejected claim 6 under 35 U.S.C. § 103(a) as obvious
over Yee and Strecker
2
(Ans. 6).
D. The Examiner rejected claims 43-46 under 35 U.S.C. § 103(a) as
obvious over Yee and Leopold
3
(Ans. 6-7).
A. 35 U.S.C. § 102(b) over Yee
The Examiner finds that “Yee discloses a delivery system for
delivering an expandable medical device to a body location, said device
having a reduced configuration and an expanded configuration” (Ans. 4).
Appellants contend that “the expandable medical device is a limitation
of the claim since the expandable medical device is required in order for the
retractable retaining wire to be wound about and to retain the expandable
medical device as recited in claim 1” (App. Br. 12).
Appellants contend that “no expandable medical device is disposed
about the „stent receiving region‟ annotated by the Examiner [in Yee]. This
is contrary to claim 1 which recites in part „the expandable medical device

1
Carl E. Yee, US 6,398,802 B1, published Jun. 4, 2002.
2
Ernst P. Strecker, US 5,405,378, issued Apr. 11, 1995.
3
Eric W. Leopold et al., US 2002/0029077 A1, published Mar. 7,
2002.
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Application 11/028,808

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disposed about the medical device receiving region in the reduced
configuration‟” (App. Br. 16).
Appellants contend that the
Examiner asserted that the through-hole 74 of Yee was a
lumen port as recited in claim 1. However, as is evident
from the annotated figures above, the through hole 74 is not
positioned centrally in the medical device receiving region
about which the graft 50 is disposed. Instead, the through
hole 74 is positioned proximal to the portion of the stent
sheath 42 about which the graft is disposed and therefore
proximal to the “medical device receiving region.”

(Id. at 17.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Yee anticipates the claims?
Findings of Fact
1. Yee teaches “a flexible, single-sheath, low-profile delivery
system for deployment of a stent inside of a biocompatible graft cover in a
distal deployment location in a body lumen from a proximal access location
outside the body lumen” (Yee, col. 2, ll. 19-23).
2. Figure 4A of Yee is reproduced below:

Figure 4A shows a “crochet weave securing a graft to the stent sheath,
shown in partial longitudinal section” (Yee, col. 4, ll. 17-20).
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Application 11/028,808

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3. Yee teaches “a crochet weave 80 may be disposed over
proximal end 66 of graft 50 to secure it to stent sheath 42” (Yee, col. 6, ll.
10-12).
4. Yee teaches that “[p]roximal end 92 of the filament is tucked
within through-hole 74 in stent sheath 42, as shown in FIG. 4A, and trailed
within the stent sheath to the outside of the body. Filament 82 may then be
pulled like a drawstring to untie crochet weave 80 loop by loop and to pull
distal end 90 out of slot 91” (Yee, col. 6, ll. 22-27).
5. Yee teaches that “exemplary stent delivery system 40 comprises
a stent sheath 42, a compressed stent 44 underlying the stent sheath, a pusher
46 underlying the stent sheath proximal to the stent, an inner core 48, and a
compressed biocompatible graft 50 overlying distal end 52 of the stent
sheath” (Yee, col. 4, ll. 49-63).
6. Yee teaches that the “stent may be self-expanding, comprising,
for example, a shape-memory material such as nitinol, or may be any type of
elastically or thermally expandable stent known in the art” (Yee, col. 5, ll.
21-24).
7. Yee teaches that “stent 44 and overlying graft 50 are
compressed and loaded into stent delivery system 40” (Yee, col. 6, ll. 63-
64).
8. Figure 7A of Yee is reproduced below:

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Figure 7A is a “longitudinal section schematic illustrations of the stent
delivery system” (Yee, col. 4, ll. 29-30).
9. The Examiner finds that port 74 in stent sheath 42 is a lumen
port (see FF 2; Ans. 4-5).
Principles of Law
Anticipation under 35 U.S.C. § 102(b) requires that “each and every
element as set forth in the claim is found, either expressly or inherently
described, in a single prior art reference.” Verdegaal Bros., Inc. v. Union Oil
Co., 814 F.2d 628, 631 (Fed. Cir. 1987).
Analysis
In interpreting claim 1, we agree with Appellants that the limitation in
the body of claim 1 to “the expandable medical device disposed about the
medical device receiving region in the reduced configuration, the
expandable medical device further having proximal and distal device ends”
is a structural requirement and not simply an intended use recitation.
In the context of Yee, two different components might reasonably
satisfy the expandable medical device requirement, the graft 50 or the stent
44 (FF 5). If “disposed about” is interpreted as adjacent, the graft 50 or stent
44 are adjacent to the stent sheath 42, which the Examiner relies upon as
functioning as the catheter (FF 8). Indeed, even if “disposed about” is
interpreted as “around,” Figure 4A shows that graft 50 surrounds stent
sheath 42 (FF 2).
However, under either interpretation of “disposed about,” the medical
device receiving region is reasonably understood to encompass either the
entirety of stent sheath 42 or the region of stent sheath 42 which is
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surrounded by graft 50 or stent 44. In either case, the lumen port 74 of Yee
is not “positioned centrally in the medical device receiving region” as
required by claim 1. Under the interpretation where the entirety of stent
sheath 42 is the receiving region, lumen 74 in Figure 4A is clearly shown as
placed near one end of the device. When Appellants‟ interpretation of
“disposed about” is used, the lumen port would need to be found in the
receiving region where graft 50 overlaps stent sheath 42, and the lumen port
74 is not even found in that receiving region, much less centrally located in
that receiving region.
We are therefore constrained to reverse this anticipation rejection
since there is no teaching of “at least one lumen port positioned centrally in
the medical device receiving region” as required by claim 1. See Karsten
Manufacturing Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir.
2001) (“Invalidity on the ground of „anticipation‟ requires lack of novelty of
the invention as claimed … that is, all of the elements and limitations of the
claim must be shown in a single prior reference, arranged as in the claim.”).
Conclusion of Law
The evidence of record does not support the Examiner‟s conclusion
that Yee anticipates the claims.
B.-D. 35 U.S.C. § 103(a) over Yee, over Yee and Strecker, and over Yee and
Leopold
The Examiner relies upon the anticipation rejection over Yee to
address the limitation in Claim 1 of “at least one lumen port positioned
centrally in the medical device receiving region.”

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Having reversed the anticipation rejection for a failure to teach that
limitation, we also reverse the obviousness rejections since the Examiner
does not identify any teaching or suggestion in Yee, Strecker, or Leopold
which address this limitation and provides a teaching or suggestion of
obviousness.
SUMMARY
In summary, we reverse the rejection of claims 1, 2, 5, 7, 8, and 10
under 35 U.S.C. § 102(b) as anticipated by Yee.
We reverse the rejection of claims 3 and 4 under 35 U.S.C. § 103(a)
as obvious over Yee.
We reverse the rejection of claim 6 under 35 U.S.C. § 103(a) as
obvious over Yee and Strecker.
We reverse the rejection of claims 43-46 under 35 U.S.C. § 103(a) as
obvious over Yee and Leopold.

REVERSED

cdc