Ex Parte Clague et al

Board of Patent Appeals and Interferences

Jul 24, 2012

10694037 (B.P.A.I. Jul. 24, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CYNTHIA T. CLAGUE, SCOTT E. JAHNS,
PAUL T. ROTHSTEIN, THOMAS P. DAIGLE,
and RAYMOND W. USHER
____________________

Appeal 2010-004502
Application 10/694,037
Technology Center 3700
____________________

Before: JENNIFER D. BAHR, PHILLIP J. KAUFFMAN, and
JAMES P. CALVE, Administrative Patent Judges.

KAUFFMAN, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2010-004502
Application 10/694,037

2
STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims
1-6, 15-23, and 32-34. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

THE INVENTION
Appellants’ claimed invention relates to “apparatus employed in
surgery involving making precise incisions in vessels of the body,
particularly cardiac blood vessels in coronary revascularization procedures
conducted on the stopped or beating heart.” Spec. para. [0003]. Claims 1
and 18 are the independent claims on appeal, and claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. A vessel wall cutting instrument for making
an elongated slit through a vessel wall of a body
vessel of a patient having a vessel axis from an
exterior surface to an interior surface of the vessel
wall into a lumen of the body vessel comprising:
an elongated instrument shaft extending
between a shaft proximal end and a shaft distal end
and having an instrument shaft axis the elongated
instrument shaft comprising a fixed shaft member
and a movable shaft member adapted to move with
respect to the fixed shaft member in the direction
of the instrument shaft axis;
a fixed cutting blade fixed to the fixed shaft
member at the shaft distal end to extend
substantially laterally to the instrument shaft axis
to a fixed cutting blade free end, the fixed cutting
blade having a blunt distal leading blade side, a
proximal, trailing side having a fixed cutting edge,
and a cutting tip at the fixed cutting blade free end;
wherein the fixed cutting edge of the
proximal trailing side is generally straight along
Appeal 2010-004502
Application 10/694,037

3
the direction of the laterally extending fixed
cutting blade, and wherein the blunt distal leading
blade side includes a major portion spaced-apart
from the cutting tip, wherein the major portion
extends generally perpendicular to the proximal
trailing side;
a movable cutting blade having a distal,
leading edge fixed to the movable shaft member at
the shaft distal end, the movable cutting blade
extending substantially laterally to the shaft axis
and having a movable cutting edge along the
movable cutting blade distal, leading edge;
means for maintaining the movable shaft
member in a retracted position with the movable
cutting blade spaced proximally from the fixed
cutting member as the blunt distal leading blade
side is applied against the exterior surface of the
vessel wall to depress the vessel wall and is moved
laterally to pass the cutting tip of the fixed cutting
blade through the vessel wall and into the lumen of
the body vessel; and
means for moving the movable shaft
member with respect to the fixed shaft member
between the retracted position separating the fixed
and movable cutting edges and an extended
position wherein the fixed and movable cutting
edges are substantially in side-by-side alignment to
shear the vessel wall and form a slit therein.

EVIDENCE RELIED UPON AND REJECTIONS
Shapiro
Taylor '641
Taylor '108
US 5,314,440
US 6,036,641
US 6,387,108 B1
May 24, 1994
Mar. 14, 2000
May 14, 2002
Appellants seek review of the following rejections:
1. Claims 1-3 and 18-20 under 35 U.S.C. § 103(a) as unpatentable over
Shapiro and Taylor '108.
Appeal 2010-004502
Application 10/694,037

4
2. Claims 4-6, 15-17, 21-23 and 32-34 under 35 U.S.C. § 103(a) as
unpatentable over Shapiro, Taylor '108, and Taylor '641.

OPINION
The Examiner proposed to modify Shapiro’s fixed cutting blade 70 so
that the proximal, trailing side is generally straight along the direction of the
laterally extending fixed cutting blade (cutting edge at 72) and so that the
blunt distal leading blade side includes a major portion that extends
generally perpendicular to the proximal trailing side (the modified cutting
edge at 72), as taught by Taylor '108. Ans. 3-4. According to the Examiner,
such a modification was the simple substitution of one known element for
another to obtain predictable results. Ans. 4-5. Alternatively, the Examiner
reasons that a person of ordinary skill in the art would have made such a
modification in order to gain the advantage of minimizing the pressure
exerted by the blade during puncturing of the eye. Ans. 5. We examine the
prior art in light of these conclusions.
Taylor '108 describes an instrument for making incisions by inserting
the point 11 of the blade stop 16 through a first point A in a vessel, then
point 11 is pushed lightly against the interior of the vessel wall so that it may
be aligned with a point B in the vessel, following which the point 11 is
pushed through the vessel so that it protrudes from point B.1 Col. 3, l. 46 -
col. 4, l. 3 (describing utilization of embodiment shown in Figures 1-3); col.
5, ll. 48-50 (noting that the embodiment shown in Figure 6 operates like the
embodiment shown in Figures 1-3); figs. 1-3, 6b. Once blade stop 16 is so

1 Such technique may be described as similar to that utilized with a curved
seeming needle. Spec. para. [0031].
Appeal 2010-004502
Application 10/694,037

5
positioned2, cutting edge 14 of blade member 13 is moved towards and
engages the complimentary shape of groove 17a of upper surface 17 of blade
stop 16, thereby cutting the tissue positioned therebetween. Col. 5, ll. 7-16
(describing movement of similar embodiment shown in Figure 5), 48-61;
figs. 1A, 5, 6b.
Shapiro discloses an instrument having scissor action cutting surfaces
(cutting blade 70 having a cutting edge 72 directed towards cutting edge 76
of blade 74). Col. 1, ll. 4-9; col. 4, l. 46-col. 5, l. 3; figs. 2, 3, 6, 7, 12.
Thus, Shapiro’s cutting instrument has opposed cutting blades that
engage and cut in a scissor fashion for improved cutting action (col. 5, ll. 4-
16) while in contrast, the cutting instrument of Taylor '108 has a single
cutting blade that cuts by engaging a complimentary shaped blade stop and
cutting tissue disposed therebetween (col. 5, ll. 53-61). Further, the cutting
instrument of Taylor '108 has a sharp point utilized to puncture a body
lumen (e.g., a blood vessel), while Shapiro’s device is not described as
having such a point or method of use. Given this, the proposed modification
is more than the mere substitution of one known element for another known
in the field.
Where, as here, the claimed subject matter involves more than the
simple substitution of one known element for another, an analysis showing
how the fact finder determined there was an apparent reason to combine the
known elements in the fashion claimed should be made explicit. KSR Int’l
Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d
977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be

2 The embodiment of Figure 6b positioned as the embodiment shown in
Figure 1A is positioned.
Appeal 2010-004502
Application 10/694,037

6
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness”)).
The Examiner reasons that the proposed modification would gain the
advantage of minimizing the pressure exerted by the blade during puncturing
of the eye. Ans. 5. However, Shapiro’s microsurgical instrument is adapted
to be inserted into the region where surgery is to be performed, and is
suitable for use “within eyes and other internal portions of a patient.”
Shapiro, col. 1, ll. 4-16; fig. 1. We cannot discern, nor has the Examiner
identified, any disclosure that Shapiro’s device is utilized to puncture the
eye. Shapiro, passim; Ans. passim. In light of this, the Examiner’s
articulated reason for the modification lacks rational underpinnings.
Accordingly, we agree with Appellants that the proposed combination
of Shapiro and Taylor '108 is not based upon a sufficient rationale. App. Br.
9-10; Reply Br. 3. As each of the rejections is based, at least in part, on this
proposed combination, we cannot sustain either rejection.

DECISION
We reverse the Examiner’s decision to reject claims 1-6, 15-23, and
32-34.
REVERSED

Klh