Ex Parte Wittenberger et al

Patent Trial and Appeal Board

Jun 22, 2017

12609463 (P.T.A.B. Jun. 22, 2017)

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.
12/609,463 10/30/2009 Dan WITTENBERGER 21819-238CIP1(P0035597.04 8420
89554 7590 06/26/2017
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, EL 33301
EXAMINER
STRANSKY, KATRINA MARIE
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
06/26/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ptomail @ c wiplaw. com
medtronic_crdm_docketing @ c ardinal-ip .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAN WITTENBERGER, MARWAN ABBOUD,
and IONA ALINA DEAC1
Appeal 2016-001653
Application 12/609,463
Technology Center 3700
Before DONALD E. ADAMS, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Medtronic CryoCath LP. App.
Br. 3.
Appeal 2016-001653
Application 12/609,463
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1,4, and 6—8 which stand rejected
under 35 U.S.C. § 103(a) as being unpatentable over the combination of
Jimenez JR. et al. (US 2004/0054367 Al, March 18, 2004) (“Jimenez”) and
Mihalik et al. (US 7,727,191 B2, June 1, 2010) (“Mihalik”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to a medical device that includes a
catheter body having proximal and distal portions, a fluid injection lumen
disposed within elongate body, and a guidewire lumen disposed within the
elongate body. A tip portion defining a cavity in fluid communication with
the fluid injection lumen may be coupled to the distal end of the guidewire
lumen, and an expandable element may be coupled to the distal portion of
the catheter body and to the tip portion, such that the expandable element is
in fluid communication with the fluid injection lumen. Abstract.
REPRESENTATIVE CLAIMS
Claim 1 is representative of the claims on appeal and recites:
1. A medical device, comprising:
a shaping element including a proximal portion and a
distal portion and being selectively transitionable from a first
inflated geometric configuration to a second inflated geometric
configuration, the shaping element further including a
substantially noncompliant balloon biased towards the first
inflated geometric configuration;
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Application 12/609,463
an expandable element at least partially disposed within
the shaping element, wherein the shape of the expandable
element is defined at least in part by the shaping element; and
an actuator element including a proximal portion and a
distal portion, the distal portion of the actuator element being
directly coupled to the distal portion of the shaping element,
longitudinal movement of the actuator element causing the distal
portion of the actuator element to exert a direct mechanical force
on the shaping element that transitions the shaping element from
the first inflated geometric configuration to the second inflated
geometric configuration.
App. Br. 8.
ISSUE AND ANALYSIS
We agree with, and adopt, the Examiner’s reasoning and conclusion
that the claims are obvious over the cited prior art references. We address
Appellants’ arguments below.
Issue
Appellants argue the Examiner erred because the combined
references neither teach nor suggest the limitation of claim 1 reciting “an
actuator element including a proximal portion and a distal portion, the distal
portion of the actuator element being directly coupled to the distal portion
of the shaping element.” App. Br. 6.
Analysis
The Examiner finds, in relevant part, that Jimenez teaches a medical
device (ablation catheter 12, Figures 1—6), comprising: a shaping element
(balloon 26, Figures 1—2) including a proximal portion (proximal section of
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Application 12/609,463
26, Figures 1—2) and a distal portion (distal section of 26, Figures 1—2),
selectively transitionable from a first inflated geometric configuration to a
second inflated geometric configuration. Final Act. 4 (citing Jimenez 141).
The Examiner finds Jimenez teaches the shaping element further includes a
substantially non-compliant balloon biased towards the first inflated
geometric configuration. Id. (citing Jimenez H 46, 47).
The Examiner further finds that Jimenez teaches an actuator element
(moveable tubes 56, 58, Figures 1—3), including a proximal portion and a
distal portion; the distal portion of the actuator element being directly
coupled to the distal portion of the shaping element. Final Act. 4 (citing
Jimenez H 41, 43).
Appellants dispute the Examiner’s findings, asserting, rather, that
Jimenez teaches that the movable tubes 56 and 58 extend through the inner
support member 30 and that the distal ends of the movable tubes 56 and 58
are both anchored to a distal tubing 60 that is distal to the transducer 28 and
the distal end of the inner support member 30. App. Br. 5 (citing Jimenez
140). Appellants assert Jimenez teaches that the distal tubing 60, to which
the distal end of the balloon 26 is anchored, preferably also carries one or
more electrodes, such as the tip electrode 80, that is mounted on the distal
end of distal tubing 60, and the ring electrode 82, that is mounted on the
distal tubing proximal to the tip electrode. Id. (citing Jimenez 156).
Therefore, Appellants argue, Jimenez expressly distinguishes the distal
tubing 60 from the outer movable tube 56. Id. Appellants also point to
Figure 2 of Jimenez, which depicts a structural delineation between these
components. Id.
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Application 12/609,463
Consequently, Appellants argue, the balloon 26 of Jimenez is
mounted to the distal tubing 60 and not to the outer movable tube 56, as
found by the Examiner. App. Br. 5.
The Examiner responds that Jimenez teaches that the actuator
elements (movable tube 56) has a distal end portion that is indistinguishable
from the distal tube portion 60. Ans. 4 (citing Jimenez Figs. 1, 4, 4B). The
Examiner finds that the distal tube 60 is in fact the distal end of the tube 56,
and therefore constitutes the “distal end portion” of the actuator. Id.
The Examiner finds Jimenez expressly teaches that the distal neck
region 54 of the balloon 26 is disposed about, and directly attached to, the
distal end of the actuator at tube portion 60 using glue or heat. Ans. 4
(citing Jimenez 141). Therefore, the Examiner finds, tube 56, which
includes a distal portion 60, is directly connected to the distal portion of the
balloon 26 at the balloon neck region 54. Id. Because Jimenez teaches that
tube portion 60 is the distal end portion of the actuator element 56; the
Examiner therefore finds the distal end portion of the actuator is directly
connected to the distal portion neck region 54 of the balloon 26. Id.
The Examiner further finds that the longitudinal movement of the
actuator element (56 and 58) of Jimenez causes direct mechanical force on
the balloon 26 since the balloon 26 is glued or welded to distal portion 60 of
the tube 56 to transition the balloon 26 from a first configuration to a
second configuration in the inflated state. Ans. 4. The Examiner finds
Jimenez expressly teaches that the distal neck region 54 of the balloon 26 is
pulled relative to the proximal neck region 52 by longitudinal movement of
the moveable tubes 56 and 58 relative to the catheter 12 and transducer 2 to
thereby change the shape of the expanded balloon 26. Id. at 4—5 (citing
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Jimenez 141). The Examiner finds that, in order for the distal neck region
54 to be pulled relative to the proximal neck region 52 there is a direct
connection between the tube portions 56 and 60, as depicted in Figures 4
and 4B of Jimenez. Id. at 5. Therefore, the Examiner finds, the distal end
portion of the actuator, as shown by portion 60, is “directly coupled” to the
distal neck portion 54 of the balloon 26 (shaping element) as required by
claim 1. Id.
Appellants reply that Jimenez teaches that the movable tubes 56 and
58 extend through the inner support member 30 and that the distal ends of
the movable tubes 56 and 58 are both “anchored to a distal tubing 60 that is
distal to the transducer 28 and the distal end of the inner support member
30.” Reply Br. 6 (citing Jimenez 140). Further, Appellants argue, Jimenez
discloses that the distal tubing 60, to which the distal end of the balloon 26
is anchored, preferably also carries one or more electrodes, such as tip
electrode 80, mounted on the distal end of distal tubing 60. Id. Appellants
argue Jimenez also teaches that the ring electrode 82 is mounted on the
distal tubing proximal to the tip electrode. Id. (citing Jimenez 156).
Therefore, Appellants assert Jimenez explicitly distinguishes the distal
tubing 60 from the outer movable tube 56, as is further shown in Figure 2 of
Jimenez, which allegedly depicts a structural delineation between these
components. Id. at 6—7. Consequently, Appellants argue, balloon 26 is
mounted to the distal tubing 60 and not to the outer movable tube 56, as
asserted by the Examiner. Id. at 7.
Furthermore, Appellants argue, Jimenez teaches that the outer
movable tube 56 does not extend into the tip electrode but has its distal end
mounted closer to the proximal end of the distal tubing 60. Reply Br. 8
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(citing Jimenez 161). According to Appellants, Jimenez also teaches that
movable tubes 56 and 58 are made of any suitable biocompatible material,
and preferably polyimide, whereas the distal tubing 60 is made of any
suitable biocompatible material, and preferably a non-conductive material
such as polyurethane. Id. (citing Jimenez 140). Because Jimenez expressly
distinguishes the structure of movable tubes 56 and 58 from the distal
tubing 60, the latter cannot be deemed to be included as part of the movable
tubes 56 and 58, as found by the Examiner. Id.
We are not persuaded by Appellants’ arguments. Claim 1 recites, in
relevant part: “an actuator element including a proximal portion and a distal
portion, the distal portion of the actuator element being directly coupled to
the distal portion of the shaping element.” Paragraph [0040] of Jimenez
recites:
A mechanism is provided for changing the shape of the
expanded balloon 26. As shown in FIGS. 4 and 4B, two
moveable tubes, an outer moveable tube 56 and an inner
moveable tube 58, extend through the inner support member 30,
the guide wire lumen 17 in the distal 10 region 15 of the catheter
body 12, the single lumen of the catheter body, and into the
control handle 16. The distal ends of the moveable tubes 56 and
58 are both anchored to a distal tubing 60 that is distal to the
transducer 28 and the distal end of the inner support member 30,
as shown best in FIG. 4B. The proximal ends of the moveable
tubes 56 and 58 extend into the control handle 16, where the
outer moveable tube 56 terminates. The inner moveable tube 58
extends out the proximal end of the control handle 16 and is
anchored to a mechanism attached to the control handle for
causing longitudinal movement of the moveable tubes relative to
the catheter body 12 and inner support member 30, as described
further below. The moveable tubes 56 and 58 are made of any
suitable biocompatible material, and preferably polyimide. The
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distal tubing 60 is made of any suitable biocompatible material,
and preferably a non-conductive material such as polyurethane.
Jimenez thus teaches that moveable tubes 56 and 58 are “anchored”
to a distal tubing 60 and may be composed of the same material, i.e., a
suitable biocompatible material. Figure 4B of Jimenez, referred to in the
quoted passage, is reproduced below:
FIG. 43
Figure 4B depicts a lateral cross-section of the distal end of the
disclosed invention of Jimenez
Figure 4B of Jimenez illustrates that the outer moveable tube 56,
which is a cylinder (see Jimenez Fig. 3), is continuous with, and appears to
be made of the same material as, the distal tubing 60 at both top and bottom
of the Figure (see also Jimenez Fig. 4). Neither Figure 4 nor Figure 4B of
Jimenez depicts a detectable boundary or delineation between moveable
tube 56 and distal tubing 60.
The test of obviousness is what the combined teachings of the
references would have suggested to those of ordinary skill in the art. In re
Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). We are persuaded by the
Examiner’s finding that a person of ordinary skill in the art would
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Application 12/609,463
understand that, although paragraph [0040] of Jimenez teaches that the
moveable tube 56 is “anchored to the distal tubing 60,” an obvious variation
of this teaching, as expressly depicted in both Figures 4 and 4B of Jimenez,
would have been that the moveable tube 56 and the distal tubing 60
represent segments of a continuous tube.
Jimenez also teaches that:
The distal neck region 54 of the balloon is disposed about and
attached to the distal end of the distal tubing 60, preferably using
glue or heat. Longitudinal movement of the moveable tubes 56
and 58 relative to the catheter body 12 and transducer 28 causes
the distal neck region 54 of the balloon to be pulled relative to
the proximal neck region 52, thereby changing the shape of the
expanded balloon.
Jimenez 141. Consequently, we agree with the Examiner that a person of
ordinary skill would conclude that moveable tube 56 and distal tube 60
could be different regions of a singular tube.In light of this, we agree with
the Examiner’s finding that Jimenez teaches the claim element that the
distal portion of the actuator is directly coupled to the distal portion of the
shaping element because the distal neck region of the balloon (i.e., the
“expandable element” of claim 1) is directly coupled to the distal end of the
distal tubing 60, which is a part of the moveable tube 56.
Consequently, we affirm the Examiner’s rejection of the claims.
DECISION
The Examiner’s rejection of claims 1, 4, and 6—8 under 35 U.S.C.
§ 103(a) is affirmed.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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