Ex Parte Gabbay

Board of Patent Appeals and Interferences

Sep 17, 2008

09973609 (B.P.A.I. Sep. 17, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte SHLOMO GABBAY
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Appeal 2008-4369
Application 09/973,609
Technology Center 3700
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Decided: September 17, 2008
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Before TONI R. SCHEINER, LORA M. GREEN, and
RICHARD M. LEBOVITZ, 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 final rejection of claims 21-28, 51, 52, and 61-70. We have
jurisdiction under 35 U.S.C. § 6(b).

Appeal 2008-4369
Application 09/973,609

STATEMENT OF THE CASE
The claims are directed to an implantation system for delivering a
heart valve prosthesis. Claim 51 is representative of the claims on appeal,
and reads as follows:
51. An implantation system, comprising:
an elongated cylindrical member having spaced apart ends, at least
one of the ends providing an opening;
a body portion from which the cylindrical member extends to
terminate in the opening that is spaced longitudinally apart from the body
portion, the body portion having a greater outer diameter than the cylindrical
member, the cylindrical member having an inner diameter in a range from
about 5 mm to about 15 mm, the cylindrical member and body portion being
substantially coaxial along a linear axis extending through the cylindrical
member and the body portion;
a heart valve prosthesis including a generally cylindrical support
having axially spaced apart ends, a valve mounted within the support at a
fixed axial position between the spaced apart ends of the support, the
prosthesis being deformable to a first condition in which the prosthesis has a
reduced cross-sectional dimension, the support being biased to expand the
prosthesis radially outwardly from the first condition to a second condition
in which the prosthesis has a cross-sectional dimension that is greater than
the reduced cross-sectional dimension, the prosthesis being mounted within
the cylindrical member in the first condition; and
a plunger operative to traverse at least part of the cylindrical member
and urge the prosthesis from the cylindrical member through the opening.

The Examiner relies on the following references:
Stevens US 5,370,685 Dec. 6, 1994
Vesely US 5,549,665 Aug. 27, 1996
Del Toro US 5,733,267 Mar. 31, 1998
Torossian US 5,851,210 Dec. 22, 1998
Shokoohi US 6,077,296 Jun. 20, 2000

We reverse.
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ISSUE (Obviousness)
The Examiner contends that claims 21, 28, 51, 61-63, 67, and 70 are
obvious over the teachings of Stevens.
Appellant contends that the Examiner has failed to show reasons why
the ordinary artisan would modify the teachings of Stevens to arrive at the
claimed invention.
Thus, the issue on Appeal is: Has the Examiner provided sufficient
reasons and/or evidence as to why the ordinary artisan would modify the
teachings of Stevens to arrive at the claimed invention?

FINDINGS OF FACT
FF1 The invention relates to an improved heart valve prosthesis and
methods of implanting the prosthesis that are efficient and less invasive
(Spec. 2).
The heart valve prosthesis is inserted into a generally
cylindrical and elongated enclosure, such that the prosthesis has
a reduced cross-sectional dimension generally corresponding to
an internal dimension of the cylindrical enclosure. An opening
is formed in a blood vessel and the portion of the enclosure
holding the prosthesis is inserted through the opening. The
cylindrical enclosure is positioned at a desired position and the
prosthesis is discharged from the enclosure. As a result, the
discharged heart valve prosthesis expands from the reduced
cross-sectional dimension to an expanded cross-sectional
dimension, such that an exterior portion of the heart valve
prosthesis engages adjacent tissue to mitigate axial movement
of the prosthesis relative to the adjacent tissue. The method can
be performed without cardiopulmonary bypass as well as
without opening the patient’s heart.

(Spec. 3.)
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Application 09/973,609

FF2 Figure 19 of the Specification is reproduced below.

Figure 19 shows an implanter apparatus, 700, that may be used to implant a
heart valve prosthesis, 702 (Spec. 26).
FF3 The implanter includes a cylindrical barrel, 704, which extends from
the body 706, and terminates in an open end 708 (id.).
FF4 The implanter further includes a plunger 716, the plunger having an
elongated portion extending from its distal end 718 and terminating in the
proximal end 718 (id. at 27).
FF5 The Examiner rejects claims 21, 28, 51, 61-63, 67, and 70 under
35 U.S.C. § 103(a) as being obvious over Stevens (Ans.1 4).
FF6 The Examiner relies on Figures 9 and 10 of Stevens (Ans. 4-5),
reproduced below.

1 All references to the Answer are to the Examiner’s Answer dated October
19, 2007.
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Figure 9 shows a side view of the valve introducer capsule of Stevens,
wherein balloons are passed over a guide wire, and Figure 10 shows a
pusher disc advancing a valve out of the introducer capsule (Stevens, col. 3,
ll. 19-22).
FF7 According to the Examiner, the implantation system of Stevens has a
body portion (essentially indicated by 70) and a cylindrical member
extending from the body portion (Ans. 5). Also included is a heart valve
prosthesis with a generally cylindrical support 85. As can be seen in the
Figures, the system also includes a plunger 60 to urge the prosthesis from
the cylindrical member (id.).
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FF8 The Examiner acknowledges that “Stevens fails to disclose the
cylindrical member extends to terminate in an opening spaced longitudinally
apart from the body member.” (Ans. 5-6.)
FF9 Stevens teaches that an advantage of the system is “the ability to
replace or supplant existing cardiac or other valves or prosthesis via a
sutureless endovascular means avoiding the riskier, more expensive and
complicated open heart surgical procedure.” (Stevens, col. 5, ll. 2-5.)
FF10 The introducer capsule is made so that it can easily be maneuvered
easily through the vasculature, and is introduced over a guide wire to the
desired site (Stevens, col. 5, ll. 29-46).
FF11 Thus, Figures 9 and 10 show a guide wire 65 and a mounting balloon
75 (Stevens, col. 8, ll. 29-40).
FF12 As to the bracer 70, Stevens teaches:
The bracer (70) is circumferentially attached to the
external surface of the introducer capsule at the capsule's
proximal end. The bracer comprises a differentially expandable
device, such as a series of segmented balloons, and is
characterized as having the capability of expanding to hold the
introducer capsule in a precise position during delivery of the
prosthetic valve device (FIG. 8). Each segmented balloon can
have an inflation/deflation channel to provide autonomous
segmental expansion and compression. Differential expansion
of the series of segmented balloons is directed from a central
external control as done with the intraluminal procedure
devices. Inflation of each differentially allows accurate
positioning of the introducer capsule in proximity to the desired
site of valve placement.

(Col. 7, ll. 38-52.)

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PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
Moreover, “[o]ften, it will be necessary . . . to look to interrelated
teachings of multiple [references] . . . and the background knowledge
possessed by a person having ordinary skill in the art, all in order to
determine whether there was an apparent reason to combine the known
elements in the fashion claimed[.]” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct.
1727, 1740-41 (2007). “[T]his analysis should be made explicit” (id. at
1741), and it “can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does” (id.).

ANALYSIS
The Examiner concludes:
It would have been an obvious expedient to have the cylindrical
member terminate apart from the body member such that it
enables the surgeon to deliver the prosthesis to an area that is at
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a distance from the area where the delivery device can be
stabilized for the surgeon to precisely place the implant. It is
often difficult to stabilize the delivery catheter device where
deployment occurs or at the opening of the cylindrical member,
thus the provision of a stabilizing member at a distance or apart
from the delivery opening can be advantageous such that it is
enables stabilization in a location of a vessel and the surgeon is
provided with the precision necessary by not having the
cylindrical member move.

(Ans. 6.)
Appellant argues that the “Examiner has failed to show reasons that
the skilled artisan, confronted with the same problems as the inventor and
with no knowledge of the claimed invention, would select the elements from
the cited prior art references for combination in the manner claimed.” (App.
Br.2 10-11.) According to Appellant, Stevens teaches that “the bracer (70),
which comprises a differentially expandable device, such as a series of
segmented balloons, is circumferentially attached to the external surface of
the introducer capsule at the capsule’s proximal end.” (Reply Br. 5 (citing
Stevens, col. 7, ll. 38-42).)
The Examiner appears to equate the bracer 70 of Stevens with a
stabilizing member, reasoning that “the provision of a stabilizing member at
a distance or apart from the delivery opening can be advantageous such that
it is [sic] enables stabilization in a location of a vessel and the surgeon is
provided with the precision necessary by not having the cylindrical member
move.” (Ans. 6.) However, as taught by Stevens, the bracer 70 is the
proximal end of the introducer capsule and is made up of segmented

2 All references to the Appeal Brief are to the Brief dated June 27, 2007.
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balloons that allow the introducer capsule to be held in precise position for
the delivery of the prosthetic valve device, allowing accurate positioning of
the introducer capsule in proximity to the desired site of the valve
replacement (FF12). The Examiner has not provided reasoning or evidence,
given the above teaching of Stevens, that is, that the bracer 70 allows for
accurate positioning at the desired site of placement of the valve prosthesis,
as to why the ordinary artisan would thus move it back away from the
cylindrical end.
Thus, we agree with Appellant, and conclude that the Examiner has
failed to set forth a prima facie case of obviousness, and the rejection is
reversed.

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CONCLUSIONS OF LAW
We conclude that the Examiner has not provided sufficient reasons
and/or evidence as to why the ordinary artisan would modify the teachings
of Stevens to arrive at the claimed invention, and thus has failed to set forth
a prima facie case of obviousness, and the rejection is reversed.
The Examiner also rejects claim 52 under 35 U.S.C. § 103(a) over the
combination of Stevens and Torossian (Ans. 6-7); claims 22-26, 65, 66, 68,
and 69 under 35 U.S.C. § 103(a) as being obvious over the combination of
Stevens and Shokoohi (Ans. 7); claim 27 under 35 U.S.C. § 103(a) over the
combination of Stevens and Vesely (Ans. 7-8); and claim 64 under 35
U.S.C. § 103(a) over the combination of Stevens and Del Toro (Ans. 8). As
each rejection relies on Steven as discussed above, and as none of the
secondary references remedies the deficiencies of Stevens, these rejections
are also reversed.

REVERSED

cdc

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