Ex Parte Rashidi

Board of Patent Appeals and Interferences

Mar 21, 2011

10260242 (B.P.A.I. Mar. 21, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
10/260,242 09/30/2002 Rassoll Rashidi 0B-043101US/82410-0119 1278
55962 7590 03/22/2011
SJM/AFD-WILEY
Legal Department
One St. Jude Medical Drive
St. Paul, MN 55117-9913
EXAMINER
SCHAETZLE, KENNEDY
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
03/22/2011 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 St. Jude Medical, Atrial Fibrillation Div. Inc.
____________

Appeal 2009-012594
Application 10/260,242
Technology Center 3700
____________

Before RICHARD E. SCHAFER, JAMESON LEE and RICHARD
TORCZON, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

Appeal 2009-012594
Application 10/260,242

2
STATEMENT OF THE CASE
This is a decision on appeal by St. Jude Medical, Atrial Fibrillation
Division, Inc. (“St. Jude”), under 35 U.S.C. § 134(a) from a final rejection of
claims 22-38 of Application 10/260,242. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
The Invention
The invention is directed to a motorized electrophysiology/ablation
catheter actuating assembly. The key elements, in the context of this appeal,
are a pair of tension/compression members disposed in a flexible tubular
member, which members include a segment having a generally circular
cross-section and a segment having a generally flattened cross-section. A
motor drive drives a means for converting rotation to linear movement, and
the converting means simultaneously pushes and pulls the two
tension/compression members to cause curvature of the tubular member.
Claim 22 is the only independent claim and it reads as follows:
22. A motorized electrophysiology/ablation catheter
actuating assembly comprising:

a) an elongated flexible tubular member having a distal
end and a proximal end and having a pair of
tension/compression members disposed therein and
kinematically joined in said distal end, said
tension/compression members extending through the proximal
end of said tubular member, and wherein said
tension/compression members include a segment having a
generally circular cross-section and a segment having a
generally flattened cross-section;

b) a hollow handle structure attached to the proximal end
of said tubular member, said handle structure having therein a
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motor drive including means for converting motor rotation to
linear movement with the proximal ends of said
tension/compression members connected to said means for
converting;

c) a source of electric power disposed in said handle
structure and user operated switch means disposed on said
handle structure for energizing said motor drive, wherein said
motor drive is operative, upon being energized for rotation in
one direction, to cause said means for converting rotation to
simultaneously pull and push said first and second
tension/compression members respectively and effect curvature
of said tubular member in one direction; and said motor drive is
operative, upon being energized for rotation in a direction
opposite said one direction to cause said means for converting
rotation to simultaneously pull and push said second and first
tension/compression members respectively and effect curvature
of said tubular member in the opposite direction.

Reference Relied on by the Examiner
Stevens-Wright Patent 5,383,852 Jan. 24, 1995

Lundquist et al. (“Lundquist”) Patent 5,254,088 Oct. 19, 1993

Shlomo Patent 6,272,371 Aug. 7, 2001

Tu et al. (“Tu”) Patent 6,221,070 Apr. 24, 2001

Edwards et al. (“Edwards”) Patent 5,531,676 Jul. 2, 1996

The Rejections on Appeal

Claims 22, 24, and 30-38 were finally rejected by the Examiner under
35 U.S.C. § 103 as unpatentable for obviousness over Stevens-Wright and
Lundquist.

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Claim 23 was finally rejected by the Examiner under 35 U.S.C. § 103
as unpatentable for obviousness over Stevens-Wright, Lundquist, and
Shlomo.
Claim 25 was finally rejected by the Examiner under 35 U.S.C. § 103
as unpatentable for obviousness over Stevens-Wright, Lundquist, and Tu.
Claims 26-29 were finally rejected by the Examiner under 35 U.S.C.
§ 103 as unpatentable for obviousness over Stevens-Wright, Lundquist, and
Edwards.

DISCUSSION
The Obviousness Rejection of Claims 22,
24, and 30-38 over Stevens-Wright and Lundquist

The Examiner determined (Answer 3:20-23) and St. Jude does not
dispute that Stevens-Wright discloses an embodiment of its catheter
invention which includes all the elements of claim 22 except for use of a
motor drive and the use of first and second tension/compression members
which include a segment having a generally circular-cross section and a
segment having a generally flattened cross-section.
The Examiner also determined that Stevens-Wright discloses that
typical prior art devices in this field employ either manual or motorized
drive to control tension/compression members, citing column 2, lines 11-24.
Reproduced below are lines 17-21 of column 2:
The prior art devices show that each cable pair may be
manipulated using a variety of mechanical actuators such as
slide levers, gear trains, or a single thumb wheel pulley, each
being operated manually or using a motor. (Emphasis added.)

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On that basis, the Examiner found that in the catheter field it is
general knowledge to one with ordinary skill in the art that a motor drive
may be used to control or manipulate catheter tip movement. (Answer 4:3-
6). That finding is well supported by the above-quoted text and appears not
disputed by St. Jude. Instead, St. Jude asserts that Stevens-Wright teaches
away from using a motor drive to control or manipulate catheter tip
movement, citing column 2, lines 21-23 of Stevens-Wright, which are
directed to prior art devices:
For the most part, these actuators [of the prior art] function, but
they are expensive to manufacture and difficult or cumbersome
to use.

We disagree that Stevens-Wright teaches away from using a motor
drive to control catheter tip movement.
The above-quoted text refers to all of the discussed prior art, which
includes actuators which are operated manually and actuators which are
operated by use of a motor. If the above-quoted text constitutes a teaching
away, it would teach away from both manual and motorized operation of a
catheter, and leave nothing left that is permissive. That is not the case. It
merely indicates that there is room for improvement in prior art devices,
both manual and motorized type. It does not say anything about whether
manual control should be used over motorized control, or vice versa.
Even assuming that the quoted text is directed to only prior art
catheters with motorized control, St. Jude’s assertion is still without merit.
The text states that for the most part the actuators of the prior art do
“function” and does not indicate that the prior art actuators are inoperative or
do not work. It does state that the prior art devices are expensive to
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manufacture and difficult or cumbersome to use, but that merely describes
the characteristics of a functioning and operative prior art device to show
what can be improved. Although it constitutes a criticism of the
performance of prior art devices, it is not a “teaching away” against the
technical disclosure of the prior art. To the contrary, it acknowledges the
existence of prior art devices and gives the affirmative assessment that they
do function.
Citing In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004), St. Jude
argues that because Stevens-Wright describes the use of motors as expensive
and cumbersome, it criticizes and discourages St. Jude’s claimed invention
and thus that constitutes a teaching away. The argument is misplaced.
As we have already discussed above, both manual and motorized prior
art are described as expensive and cumbersome. Thus, based on the cited
text Stevens-Wright does not criticize and discourage the use of a motor
drive in favor of a manual embodiment without a motor drive. More
importantly, the language “criticize” and “discourage” appearing in
In re Fulton must be read in the proper context. It does not mean the kind of
criticism or discouragement that simply points out relative advantages and
disadvantages between alternative designs all of which function or are
workable. Rather, it denotes something that would be regarded as
inoperative, non-functional, or ineffective. Note the following discussion in
In re Fulton, 391 F.3d at 1201:
Davies [prior art reference] communicates in its specification
that its claimed invention, which includes hexagonal surfaces in
a pointing orientation, has “a nonskid characteristic effective in
all directions relative to its use.” U.K. Patent No. 513,375
(accepted Oct. 11, 1939) at 2, II. 19-20. But Davies does not
teach that hexagons in a facing orientation would be
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ineffective. Accordingly, we find unpersuasive appellants’
arguments that the prior art teaches away from hexagonal
surfaces in a facing orientation. (Emphasis added.)

For the foregoing reasons, St. Jude’s assertion that the statement at
issue in Stevens-Wright constitutes a teaching away from using a motor
drive in the catheter assembly, as the prior art already discloses, is without
merit and rejected. Stevens-Wright discloses the use of a motor drive in pre-
existing prior art and acknowledges that such use did in fact function.
In any event, whether Stevens-Wright constitutes such a teaching
away is inconsequential, because the record supports the Examiner’s finding
that it is general knowledge to one with ordinary skill in the art that a motor
drive may be used to control or manipulate catheter tip movement. The
level of ordinary skill is such that one with ordinary skill would have known
that catheter tip movement may be controlled by a motor drive. It does not
matter that the invention of Stevens-Wright does not use a motor drive.
Stevens-Wright also discloses using a plurality of pull cables 32a,
32b, 32c, and 32d, which are tension/compression members, to steer the
catheter. (Stevens-Wright 3:42-55). However, they are not of the type
including a segment with a generally circular cross-section and a segment
with a generally flattened cross-section, as is required by claim 22.
Lundquist discloses a catheter steering mechanism including a
steering shaft coupled to a controller which includes a handle and apparatus
for manipulating the distal end of the steering shaft. (Lundquist, Abstract ll.
1-3). Lundquist also discloses steering wires which extend through the
steering shaft to the controller from a fixed position at a distal end of the
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steering shaft. (Lundquist, Abstract ll. 6-11). The controller is used to place
tension on one or both of the steering wires. (Lundquist, Abstract 9-11).
More importantly, Lundquist states (col. 7:2-8):
As shown in FIG. 8, carried within the distal end 340 are a lead
spring 350 and two steering wires 360 and 370. The steering
wires 360 and 370 are preferably rounded towards their
proximal ends, and flattened towards their distal ends, as with
the steering wire 120 shown in FIG. 1.

Figures 1, 2, and 8 of Lundquist are reproduced below - Figure 8
shows steering wires 360 and 370 within the steering shaft and Figures 1 and
2 illustrates the dual-segment configuration, one rounded and one flattened,
of steering wire 120 which is representative of steering wires 360 and 370:

The steering wires in Lundquist serve the same function as the cables
in Stevens-Wright, i.e., guiding or bending the distal end of the catheter.
(Stevens-Wright, 3:50-55; Lundquist, Abstract, ll.14-25). Lundquist also
states this with regard to its disclosed catheter (Lundquist, 4:1-6):
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The catheter 40 is any standard catheter, such as an
angioplasty catheter (for least angioplasty, balloon angioplasty,
or other treatments), a catheter with pacing and/or sensing
probes, or indeed any flexible or steerable device which one
may wish to introduce into a place which is difficult to reach.

The Examiner reasonably determined that in light of Lundquist’s
disclosure that the steering wires are preferably rounded towards the
proximal end and flattened towards the distal end, one with ordinary skill in
the art would have known that the cables of Stevens-Wright can be similarly
configured. Although Lundquist does not describe why it is preferable for
its cables to embody that dual shape, it is sufficient that it states that such a
configuration is preferable. One with ordinary skill in the art would have
known to adopt a configuration that a prior art reference describes as
preferred, regardless of the underlying rationale. Note also that in an
obviousness analysis, it is not necessary that prior art teachings be combined
by the Examiner for the same reasons contemplated by the inventors of the
claimed invention on appeal. In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir.
1992).
Finally, St. Jude argues that all of the illustrated embodiments of
Stevens-Wright pertain to a catheter that bends in two planes and thus if the
preferred cable configuration of Lundquist were adopted in Stevens-Wright
the flattened shape of one pair of cables 32a and 32c would thwart the
desired bending in the perpendicular plane, and the same would be true with
regard to the other pair of cables 32b and 32d with respect to the other plane.
The argument is misdirected and without merit.
As is pointed out by the Examiner (Answer 14-15), the two pairs of
steering cables (32a and 32c)/(32b and 32d) are not co-extensive and do not
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cause bending at the same axial location on the catheter. The catheter does
not need to bend where any cable, if implemented with the configuration
preferred by Lundquist, thwarts bending. Consequently, as noted by the
Examiner, adopting the configuration suggested by Lundquist would not
result in the two pairs of cables working in contravention to the operation
and characteristics of each other. In that regard, Figure 2 of Stevens-Wright
as annotated by the Examiner and referenced in the Examiner’s Answer on
page 16, is reproduced below:

Also, as is pointed out by the Examiner, Stevens-Wright is not limited
to applications where the catheter needs to bend in two orthogonal or
perpendicular planes. For instance, in column 4, lines 15-25, Stevens-
Wright states:
Although the illustrated embodiment provides
perpendicular planes of proximal and distal movement, the
relative orientation between these two planes may vary with
different catheter applications and desired tip-shapes and the
two planes may form angles between zero degrees and one
hundred eighty degrees. By varying the angle of intersection
between the two planes, one catheter tip arrangement, for
example a two-dimensional arrangement (where both planes are
coplanar), may be bent into a specific shape (such as a spiral)
within the single plane of movement. (Emphasis added.)

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Having filed no reply, St. Jude provides no rebuttal to the above-
referenced findings and explanations appearing in the Response to Argument
section of the Answer.
St. Jude has not separately argued the merits of claims 24 and 30-38
from that of independent claim 22.
For the foregoing reasons, we affirm the rejection of claims 22, 24,
and 30-38 under 35 U.S.C. § 103 as unpatentable for obviousness over
Stevens-Wright and Lundquist.
The Obviousness Rejection of Claim 23
over Stevens-Wright, Lundquist and Shlomo

Claim 23 depends from claim 22 and further recites “said handle
structure includes a position sensor for sensing the position of a member of
said means for converting motor rotation to linear motion as an indication of
the radius of curvature of the distal portion of said tubular member.”
In its appeal brief, St. Jude indicates that it does not understand the
rejection because position sensing elements of Shlomo senses positions on
the catheter itself and not positions on a member of a means for converting
motor rotation to linear motion. St. Jude also states that Stevens-Wright can
only sense a non-deflected position of the catheter and it appears the
Examiner has not given the claim language recited in claim 23 appropriate
consideration. (Brief, 12:12-13).
In the Response to Argument section of the Answer, the Examiner, on
pages 18-20, addressed St. Jude’s concerns and specifically explained the
basis of the underlying obviousness analysis. The Examiner does not rely on
the specific sensors 28 and 30 of Shlomo and does not contend that Stevens-
Wright itself already discloses the feature at issue with regard to claim 23.
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rather, on pages 18-20 of the Answer, the Examiner presents a well reasoned
obviousness-analysis based on the combined teachings of Stevens-Wright,
Lundquist, and Shlomo, which need not be repeated here.
Having filed no reply, St. Jude has not addressed the Examiner’s
stated reasoning. We are not persuaded of error in the rejection of claim 23.

The Obviousness Rejection of Claim 25
over Stevens-Wright, Lundquist, and Tu

Claim 25 depends on claim 24 which depends from claim 22. St. Jude
does not separately argue the merits of claim 25 in this rejection from that of
claims 22 in the obviousness rejection of claim 22 based on Stevens-Wright
and Lundquist.
For the same reasons discussed above with regard to the rejection of
claims 22, the rejection of claim 25 is affirmed.
The Obviousness Rejection of Claims 26-29
over Stevens-Wright, Lundquist, and Edwards

Each of claims 26-29 depends directly or indirectly from claim 22. St.
Jude does not separately argue the merits of claims 26-29 in this rejection
from that of claim 22 in the obviousness rejection of claim 22 based on
Stevens-Wright and Lundquist. The rejection of claims 26-29 is affirmed.
For the same reasons discussed above with regard to the rejection of
claim 22, the rejection of claims 26-29 is affirmed.
ORDER
The rejection of claims 22, 23, 24, and 30-38 under 35 U.S.C. § 103
as unpatentable for obviousness over Stevens-Wright and Lundquist is
affirmed.
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The rejection of claim 23 under 35 U.S.C. § 103 as unpatentable for
obviousness over Stevens-Wright, Lundquist, and Shlomo is affirmed.
The rejection of claim 25 under 35 U.S.C. § 103 as unpatentable for
obviousness over Stevens-Wright, Lundquist, and Tu is affirmed.
The rejection of claims 26-29 under 35 U.S.C. § 103 as unpatentable
for obviousness over Stevens-Wright, Lundquist, and Edwards is affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

SJM/AFD-WILEY
Legal Department
One St. Jude Medical Drive
St. Paul MN 55117-9913