Ex Parte Avitall et al

Patent Trial and Appeal Board

Apr 9, 2013

11429051 (P.T.A.B. Apr. 9, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/429,051 05/05/2006 Boaz Avitall 05-0203 (US02) 2293
11050 7590 04/09/2013
SEAGER, TUFTE & WICKHEM, LLC
1221 Nicollet Avenue
Suite 800
Minneapolis, MN 55403
EXAMINER
SCOTT, AMANDA L
ART UNIT PAPER NUMBER
3739
MAIL DATE DELIVERY MODE
04/09/2013 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 BOAZ AVITALL and JOSEF V. KOBLISH
__________

Appeal 2011-008156
Application 11/429,051
Technology Center 3700
__________

Before DEMETRA J. MILLS, STEPHEN WALSH and ERICA A.
FRANKLIN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2011-008156
Application 11/429,051

2
STATEMENT OF CASE
1. A catheter for performing a medical procedure on tissue
adjacent an ostium of an anatomical vessel, comprising:
an elongated flexible catheter body including a proximal shaft portion
and a distal shaft portion having a proximal section pre-shaped to form a
simple curve having an apex sized to be inserted into the vessel ostium, a
medial section pre-shaped to form a complex curve, and a distal section
configured to contact the adjacent tissue when the curve apex is inserted
within the vessel ostium; and
at least one tracking element carried by the distal shaft portion.

11. A method of performing a medical procedure adjacent an
anatomical vessel using a catheter having a proximal section and a distal
section, comprising:
forming the proximal section into a curve having an apex;
inserting the curve apex into the vessel ostium to place the distal
section in contact with a first tissue site adjacent an ostium of the vessel;
determining a location of the distal section within a coordinate system
while contacting the first tissue site;
rotating the curve within the vessel about the curve apex while the
curve apex is in the vessel ostium to place the distal section in contact with a
second tissue site adjacent the vessel ostium; and
determining another location of the distal section within the
coordinate system while contacting the second tissue site.

Cited References

Kuck et al. US 5,823,955 Oct. 20, 1998
Bowe US 2001/0039413 A1 Nov. 8, 2001
Willis et al. US 6,490,474 B1 Dec. 3, 2002
Gilboa US 6,887,236 B2 May 3, 2005
Haissaguerre et al. US 6,064,902 May 16, 2000

Appeal 2011-008156
Application 11/429,051

3
Grounds of Rejection
1. Claims 1-5 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Kuck in view of Bowe.
2. Claims 6-10 are rejected under 35U.S.C. §103(a) as being
unpatentable over Kuck in view of Bowe further in view of Willis.
3. Claims 11, 16, 18-19 and 21-24 are rejected under 35 U.S.C. §
103(a) as being unpatentable over Gilboa in view of Haissaguerre.
4. Claims 17, 20 and 25 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Gilboa in view of Haissaguerre in view of
Willis.
5. Claims 13, 14 and 15 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Gilboa in view of Haissaguerre in view of
Kuck.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
11. The following facts are highlighted.
1. Specification Figs. 4 and 5 are reproduced below.
Appeal 2011-008156
Application 11/429,051

4

Specification Figure 4 shows complex curve 42. “The medial
section 42 is configured to be internally actuated from a straight
geometry to form a complex curve (ie., a curve that can be
projected onto more than one plane) in the absence of an
external force, and in particular, a compressive force.” (Spec.
17-18.)

“The particular unconstrained shape of the medial section 42, is
such, that it bends opposite to and out-of-plane with the simple
curve C1. That is, the complex curve has a proximal curve C2
that, when projected onto the plane, P1 (see Fig. 4), bends
opposite to the simple curve C1, and a distal curve C3 that,
when projected on a plane P2 that is perpendicular to the
longitudinal axis L of the proximal member 28” (see Fig. 6),
bends out of the plane P1. (Spec. 18.)

2. Figures 1 and 1B of Kuck are reproduced below.
Appeal 2011-008156
Application 11/429,051

5

Figures 1 and 1B of Kuck show proximal curve 44 and distal segment
(curve) 66 (annotated).
3. Kuck discloses that, for example, “if manipulator wire 16 were
passed into one of the satellite lumens 40 oriented 90 degrees from the
satellite lumen through which manipulator wire 16 passed, distal
segment 66 would be curved in a plane about 90 degrees to the plane
of the figures. Also, distal curve 66 could deflect in the same plane
and same direction as proximal curve 44. In an alternative
embodiment, distal curve 66 and proximal curve 44 could be actuated
by a single manipulator wire and a single handle control.” (Col. 5, ll.
20-29.)

Discussion
1. Claims 1-5 are rejected under 35 U.S.C. §103(a) as being
unpatentable for obviousness over Kuck in view of Bowe.
Appeal 2011-008156
Application 11/429,051

6
2. Claims 6-10 are rejected under 35 U.S.C. §103(a) as being
unpatentable over Kuck in view of Bowe further in view of Willis.

ISSUE
The Examiner concludes that Kuck teaches each element claimed
except
Kuck et al. fail to disclose the proximal section simple
curve as being pre-shaped. However, Bowe et al. discloses a
catheter (30) employs a shaped-memory wire (104) having a
preshaped bend in distal end region (106). At the time of the
invention, it would have been obvious to one of ordinary skill
in the art to use a pre-formed bend in order to provide the
benefit of the catheter conforming to the contour of the
biological cavity containing the tissue to be ablated as taught by
Bowe et al. ([0046]).

(Ans. 4.)

Appellants argue that
The specification defines a complex curve in its ordinary and
accustomed manner, i.e., a curve that can be projected onto
more than one plane (see page 17, line 22 to page 18, line 1).
This should be contrasted with a simple curve, which is defined
in the specification in accordance with its ordinary and
accustomed meaning, i.e., a curve that lies in a single plane (see
page 17, lines 8-12). (Br. 5-6.)

Appellants argue that
However, there is no disclosure in Kuck of a single
embodiment that bends the medical section (66) in a complex
curve that both bends in a direction opposite to the simple curve
and bends out-of-plane with the simple curve. Kuck
characterizes the medial section (66) as nothing more than a
simple curve that can be bent in one direction, or alternatively,
Appeal 2011-008156
Application 11/429,051

7
bent in another direction-but not both directions at the same
time to form a complex curve. (Br. 7.)

Appellants further explain that
Kuck discloses at col. 5, lines 18-25 that "if manipulator
wire 16 were passed into one of the satellite lumens 40 oriented
90 degrees from the satellite lumen through which manipulator
wire 16 passed, distal segment 66 would be curved in a plane
about 90 degrees to the plane of the figures."
However, this does not result in the distal segment 66
being placed in a complex curve that both bends in a direction
opposite to the simple curve and bends out-of-plane with the
simple curve. The most that this alternative embodiment
suggests is that pulling on one manipulator wire 16 will place
the distal segment 66 into a simple curve that bends opposite to
the simple curve 44, and pulling on the other manipulator wire
16 (90 degrees clocked from the first manipulator wire 16) will
place the distal segment 66 into a simple curve that bends out-
of-plane with the simple curve 44. There is simply no
disclosure in Kuck that manipulation of the two wires 16 will
place the distal segment 66 into the claimed complex curve.

(Reply Br. 2.)

The dispositive issue with respect to both of the above rejections 1
and 2 is: Does the Examiner’s cited evidence support the Examiner’s
conclusion that the references disclose a medial section pre-shaped to form a
complex curve, and a distal section configured to contact the adjacent tissue
when the curve apex is inserted within the vessel ostium, as claimed?

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
Appeal 2011-008156
Application 11/429,051

8
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, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).

ANALYSIS
We do not find that the Examiner has provided sufficient evidence to
support a prima facie case of obviousness for the catheter of claim 1 and its
dependent claims, on the evidence before us. In particular, we agree with
Appellants that the Examiner has not explained how Figures 1, 1B and 4 of
Kuck disclose a complex curve consistent with the definition in Appellants’
specification, “a complex curve in its ordinary and accustomed manner, i.e.,
a curve that can be projected onto more than one plane (see page 17, line 22
to page 18, line 1).”
Appellants have argued that Kuck discloses at col. 5, lines 18-25 that
"if manipulator wire 16 were passed into one of the satellite lumens 40
oriented 90 degrees from the satellite lumen through which manipulator wire
16 passed, distal segment 66 would be curved in a plane about 90 degrees to
the plane of the figures." However, this does not result in the distal segment
Appeal 2011-008156
Application 11/429,051

9
66 being placed in a complex curve that both bends in a direction opposite to
the simple curve and bends out-of-plane with the simple curve. The most
that this alternative embodiment suggests is that pulling on one manipulator
wire 16 will place the distal segment 66 into a simple curve that bends
opposite to the simple curve 44, and pulling on the other manipulator wire
16 (90 degrees clocked from the first manipulator wire 16) will place the
distal segment 66 into a simple curve that bends out-of-plane with the simple
curve 44. There is simply no disclosure in Kuck that manipulation of the
two wires 16 will place the distal segment 66 into the claimed complex
curve. (Reply Br. 2.) The Examiner has failed to specifically address this
argument of Appellants to indicate how Kuck discloses a complex curve.
Rejections 1 and 2 are reversed.

Discussion
3. Claims 11, 16, 18-19 and 21-24 are rejected under 35 U.S.C.
§103(a) as being unpatentable over Gilboa in view of
Haissaguerre.
4. Claims 17, 20 and 25 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Gilboa in view of Haissaguerre in view of
Willis.
5. Claims 13, 14 and 15 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Gilboa in view of Haissaguerre in view of
Kuck.

Appeal 2011-008156
Application 11/429,051

10
ISSUE
The Examiner argues that
Gilboa discloses forming the proximal section into a
curve having an apex (view figure 4A); inserting the curve apex
into the vessel ostium to place the distal section in contact with
a first tissue site adjacent an ostium of the vessel(view figure
4A, the device is implemented with a shape memory configured
to facilitate positioning in around the pulmonary vein ostium);
and determining a location of the distal section within a
coordinate system while contacting the first tissue site(column
6, lines 30-61 ); and determining another location of the distal
section within the coordinate system while contacting the
second tissue site (once the second site is in contact the use of
the coordinate system with the locating element can be used
again; column 6, lines 30-61) but fails to disclose rotating the
curve within the vessel about the curve apex while the curve
apex is in the vessel ostium to place the distal section in contact
with a second tissue site adjacent the vessel ostium. However,
Haissaguerre et al. disclose a catheter (10) for ablating and
mapping tissue that forms a curve apex (43) that is inserted into
an ostium of a vessel, placing the distal section (42) in contact
with a first tissue site and the proximal section in firm contact
with an inner surface of the vessel while the apex is in the
ostium. Haissaguerre et al. further discloses rotating the
catheter within the vessel about the curve apex while the apex is
in the vessel ostium to place the distal section in contact with a
second tissue site. (Abstract; Column 8, Lines 60-66, Column 9,
Lines 13-14, 41-42; Fig. 5-6).

(Ans. 7-8.)

Appellants argue that
In particular, independent claim 11 requires inserting the
curve apex into the vessel ostium to place the distal section in
contact with a first tissue site adjacent the vessel ostium. The
Examiner concluded that, by virtue of the fact that Gilboa
catheter is implemented with a shape memory, the curve apex
Appeal 2011-008156
Application 11/429,051

11
of the Gilboa catheter is capable of being positioning in around
the pulmonary vein ostium (see page 6, lines 8-9 of Final Office
Action).
However, whether or not the curve apex of the Gilboa
catheter is capable of being inserted into a pulmonary vein
ostium is irrelevant to an inquiry into whether or not Gilboa
actually discloses inserting the curve apex into a pulmonary
vein. Significantly, "under the principles of inherency, if a
prior art device, in its normal and usual operation, would
necessarily perform the method claimed, then the method
claimed will be considered to be anticipated by the prior art
device."

(Br. 9.)

The dispositive issue with respect to rejections 3-5 is: Does Gilboa
disclose “inserting the curve apex into the vessel ostium to place the distal
section in contact with a first tissue site adjacent the vessel ostium,” as
claimed.
ANALYSIS
We do not find that the Examiner has provided sufficient evidence to
support a prima facie case of obviousness as set forth in the Answer.
Gilboa generally discloses a catheter for ablating atrial tissue. (Col. 1,
ll. 13-17.) Figure 2E of Gilboa is reproduced below.

Appeal 2011-008156
Application 11/429,051

12
Figure 2E of Gilboa shows gradually deploying catheter assembly 10 distal
portion along a line around the internal tissue surface of the atrium. (Col. 7,
ll. 25-27.)
The Examiner relies on Gilboa for disclosing, “inserting the curve
apex into the vessel ostium to place the distal section in contact with a first
tissue site adjacent an ostium of the vessel” (Ans. 7), referencing Fig. 4A of
Gilboa. Figure 4A of Gilboa does not show insertion of the curve of a
catheter into a vessel ostium.
The Examiner further argues that
Gilboa teaches in column 7, lines 41-52, that Figure 4A, which
was cited in the final action as disclosing the claimed feature,
shows a varint [sic] implementation of the present invention in
which hollow catheter 12' is implemented with a shape memory
configured to facilitate positioning for performing an ablation
procedure requiring a line of a particular defined shape, for
instance a circular ablation around the pulmonary vein ostium.

(Ans. 12.)

As set forth in In re Oelrich, 666 F.2d 578, 581, (CCPA
1981)(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)),
inherency may not be established by probabilities or possibilities. The mere
fact that a certain thing may result from a given set of circumstances is not
sufficient. If, however, the disclosure is sufficient to show that the natural
result flowing from the operation as taught would result in the performance
of the questioned function, it seems to be well settled that the disclosure
should be regarded as sufficient.
The Examiner has not pointed to any disclosure in Gilboa of inserting
the curve apex into a pulmonary vein. Nor is there sufficient disclosure to
Appeal 2011-008156
Application 11/429,051

13
show that the natural result flowing from the operation of the catheter as
taught would result in “inserting the curve apex into the vessel ostium to
place the distal section in contact with a first tissue site adjacent the vessel
ostium.” For this reason, rejections 3-5 are reversed.

CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness
rejections. The rejections are reversed.

REVERSED

dm