Ex Parte Harvey-Poncelet et al

Patent Trial and Appeal Board

Aug 16, 2017

12603250 (P.T.A.B. Aug. 16, 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.
12/603,250 10/21/2009 Daniel HARVEY-PONCELET 21819-265U 6181
89554 7590 08/18/2017
Christopher & Weisberg, P.A.
200 East Las Olas Boulevard
Suite 2040
Fort Lauderdale, EL 33301
EXAMINER
HUPCZEY, JR, RONALD JAMES
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
08/18/2017 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 DANIEL HARVEY-PONCELET and TERESA ANN MIHALIK
Appeal 2016-004218
Application 12/603,250
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a
catheter based medical system. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“Catheter-based ablation systems are well known in the art. A
cryogenic device uses the energy transfer derived from thermodynamic
changes occurring in the flow of a cryogen therethrough to create a net
transfer of heat flow from the target tissue to the device” (Spec. 15). “Once
1 Appellants identify the Real Party in Interest as Medtronic CryoCath LP
(see App. Br. 3).
Appeal 2016-004218
Application 12/603,250
refrigerant is injected through an orifice, it may be expanded inside of a
closed expansion chamber, which is positioned proximate to the target
tissue. Devices with an expandable membrane, such as a balloon, are
employed as expansion chambers” {id. 1 8). “One of the principal
drawbacks to such a technique is that during the inflation phase coolant may
seep out of the balloon and get into the bloodstream to cause significant
harm” {id. 19). “Another situation that may occur during the balloon
deflation phase is that the balloon may adhere to the ablated tissue causing
severe damage” {id.).
Accordingly, it would be desirable to provide an
apparatus and method of monitoring and selectively controlling
the inflation and deflation phases of a medical device, such as a
balloon catheter, to reduce the time and effort of a physician in
performing one or more sequential therapy applications in a
targeted tissue region. It would also be desirable to provide a
medical device in which the balloon could be caused to
selectively and controllably deflate into its original, uninflated
and folded orientation for ease of removal and/or repositioning.
{id. 112).
The Claims
Claims 1—7 are on appeal. Claim 1 is representative and reads as
follows:
1. A medical system, comprising:
a catheter, including:
a handle including a position detection mechanism;
an elongate body extending from the handle;
a guidewire lumen at least partially disposed
within and movable within the elongate body;
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Application 12/603,250
an expandable element defining a proximal end
coupled to the catheter body and a distal end coupled to
the guidewire lumen; and
an actuator element coupled to the guidewire
lumen manipulation of the actuator element in a
longitudinal direction causing longitudinal movement of
the guidewire lumen; and
a console, the console providing circulation of a
fluid through the catheter, wherein the position detection
mechanism transmits a signal to the console causing the
console to automatically terminate fluid circulation
through the medical device when the position detection
mechanism detects movement of the actuator element in
at least one longitudinal direction.
The Issue
The Examiner rejected claims 1—7 under 35 U.S.C. § 103(a) as
obvious over Abboud2 and Kudaravalli3 (Final Act. 2—6).
The Examiner finds Abboud teaches a medical system with the
required structural elements of claim 1 (Final Act. 2—3). The Examiner finds
that:
While Abboud discloses that the movement of the actuator 46
and the lumen 16 can be used to deflate the expandable element
(see page 8, line 27 - page 9, line 6), and for the position
detector mechanism (element 56) to send a signal to control the
operation of the device . . . Abboud fails to specifically recite
that the signal specifically causes the console to terminate fluid
circulation through the medical device.
{Id. 3.)
2 Abboud et al., WO 2008/000066 Al, published Jan. 3, 2008.
3 Kudaravalli et al., US 6,471,694 Bl, issued Oct. 29, 2002.
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Application 12/603,250
The Examiner finds Kudaravalli teaches “automated valves (406/506)
which are controlled in response to a signal from the system. Kudaravalli
specifically sets forth that during shutdown of the system, the system
functions to automatically control the valving to stop fluid flow” (id.).
The Examiner finds it obvious to “utilize the automated valving of
Kudaravalli in combination with the system of Abboud to provide for an
exemplary manner of shutting down the system in order to deflate the
balloon after treatment” (Final Act. 4).
The issue with respect to the priority issue is: Does the evidence of
record support the Examiner’s conclusion that Abboud and Kudaravalli
render claim 1 obvious?
Findings of Fact
1. Figure 1 of Abboud is reproduced below:
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Application 12/603,250
Figure 1 describes a medical device 10 with
an elongate body 12, such as a catheter. ... the elongate body
12 may include a guidewire lumen 16 movably disposed within
and/or extending along at least a portion of the length of the
elongate body 12 for over-the-wire applications. ... an
expandable element 18 at least partially disposed on the
elongate catheter body. The expandable element 18 may
include a balloon.
(Abboud 3:21 to 4:5).
2. Abboud teaches the “medical device 10 may include a handle
element 20 coupled to the proximal portion of the elongate body 12, where
the handle may include an element such as a lever or knob 22 for
manipulating the catheter body and/or additional components of the medical
device 10” (Abboud 4:21—24).
3. Abboud teaches that the “medical device 10 of the present
invention may include an actuator element 46 that is movably coupled to the
proximal portion of the elongate body 12 and/or the handle 20, and further
coupled to the proximal portion of the guidewire lumen 16” (Abboud 6:9-
12).
4. Abboud teaches:
the actuator element 46 may be used in controlling a particular
geometric configuration and/or dimension of the expandable
element 18, i.e., the actuator element 46 may exert a tensile
force on the expandable element 18 to provide for an elongated,
cylindrical shape. Subsequently, the actuator element 46 may be
retracted to allow the expandable element 18 to assume a
spherical shape having a larger radius than that of the elongated
shape experienced under tension.
(Abboud 6:21-26).
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Appeal 2016-004218
Application 12/603,250
5. Abboud teaches:
medical device 10 may further include indicia located on the
handle element 20 in proximity to each distinct position in
which the actuator element 46 may be located, where the
indicia may directly correspond to a given dimension and/or
shape the expandable element 18 resulting from the particular
position of the actuator element 46.
(Abboud 7:10-14).
6. Abboud teaches:
the medical device 10 of the present invention may further
include a size detection element 56 for determining and/or
indicating a particular dimension of the expandable element 18
. . . the size detection element 56 may include a potentiometer
coupled to the handle element 20, the guidewire lumen 16
and/or the actuator element 46.
(Abboud 7:15-23).
7. Abboud teaches:
When the actuator element 46, and thus the guidewire
lumen 16 and the expandable element 18, are in a first position,
a resistance, impedance, or capacitance measurement may be
indicated by the potentiometer of the size detection element.
This measurement may be correlated to a particular dimension,
i.e., length, radius, etc., of the expandable element 18
Subsequently, the actuator element 46, guidewire, and
expandable element 18 may be moved into a second position
and/or state. This movement causes a change in the resistive,
capacitive, or impedance characteristics of the potentiometer
The information regarding the particular dimensions
and/or state of the expandable element 18 may be relayed to the
control console 34 and used to determine desirable flow rates,
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Application 12/603,250
temperatures, etc. for appropriate operation of the medical
device 10.
(Abboud 7:23 to 8:8).
8. Kudaravalli teaches “methods and apparatus for controlling the
operation of a cryosur[g]ical catheter refrigeration system by monitoring
pressures, temperature, and/or flow rate, in order to automatically maintain a
stable refrigerant flow rate” (Kudaravalli 2:4—8).
9. Kudaravalli teaches: “Flow rate, pressures, and temperature can
be used for automatic shut down control” (Kudaravalli 2:11—12).
10. Kudaravalli teaches “there is an optimum flow rate at which the
lowest temperature can be achieved, with the highest possible cooling
power. Therefore, maintaining the refrigerant flow rate at substantially this
optimum level is beneficial.” (Kudaravalli 1:38-41).
11. Kudaravalli teaches a “system in which only the refrigerant
pressure is monitored may not have effective safety control, such as
emergency shut down control” (Kudaravalli 1:52—54).
12. Kudaravalli teaches:
An exemplary shutdown sequence will now be described. Send
a signal to the fluid controller 208 to stop the primary
refrigerant flow (block 840). Energize the bypass valve 406 to
open the bypass loop (block 842). Shut off the precool
compressor 100 (block 844). Continue running the vacuum
pump 400 to pull a vacuum between the outlet of the fluid
controller 208 and the inlet of the vacuum pump 400 (block
846). Monitor primary high side pressure P3, primary low side
pressure P4, and catheter tip pressure P5 (block 848) until all
three are less than the original primary low side pressure which
was read in block 804 at the beginning of the procedure (block
850). Then, de-energize the recovery pump 500, recovery valve
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Application 12/603,250
506, vent valve 408, bypass valve 406, and vacuum pump 400
(block 852). Display a message suggesting the removal of the
catheter 300, and update a log of all system data (block 854).
(Kudaravalli 8:27—42).
Principles of Law
“[DJuring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the [Specification.” In re Hyatt,
211 F.3d 1367, 1372 (Fed. Cir. 2000)
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If aperson of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Mat417.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2—6; FF 1—12) and agree that
claim 1 is obvious over Abboud and Kudaravalli. We address Appellants’
arguments below.
Appellants contend:
the combination of the Abboud and Kudaravalli references fails
to teach or suggest that the position detection mechanism
transmits a signal to the console causing the console to
automatically terminate fluid circulation through the device
when the position detection mechanism detects movement of
the actuator element in at least one longitudinal direction.
(App. Br. 8-9).
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Application 12/603,250
We do not find this argument persuasive because claim 1 simply
requires the position detection mechanism to detect “movement of the
actuator element in at least one longitudinal direction.”
Abboud teaches a detection element 56 that may include a
“potentiometer coupled to . . . actuator element 46” (FF 6). Abboud explains
that the detection element 56 measures “[w]hen the actuator element 46, and
thus ... the expandable element 18, are in a first position, a . . .
measurement may be indicated . . . This measurement may be correlated to a
particular dimension, i.e., length ... of the expandable element 18” (FF 7).
Abboud then teaches “the actuator element 46 . . . and expandable element
18 may be moved into a second position” and that the “information
regarding the particular dimensions . . . may be relayed to the control
console 34 and used to determine desirable flow rates” (FF 7).
Thus, Abboud directly teaches that detection element 56 measures
movement of actuator 46 and expandable element 18 in dimensions
including “length.” Changes in “length” of these elements are reasonably
interpreted as a changes in longitudinal direction. Abboud teaches to adjust
the flow rate within the device based on changes in a parameter including
“length,” that is, a change in longitudinal direction.
We recognize, but find unpersuasive, Appellants’ arguments that the
“Abboud reference fails to teach or suggest that the transmission of a signal
from a position detection mechanism, or even from the ‘size detection
mechanism 56’ causes the console to automatically terminate fluid
circulation” and that “Kudaravalli reference fails to teach or disclose that
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Application 12/603,250
the signal received by the ‘fluid controller 208’ is in response to detected
longitudinal movement by a position detection mechanism.” (App. Br. 9).
We find the argument unpersuasive because “[n]on-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.” In re
Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). A reference “must
be read, not in isolation, but for what it fairly teaches in combination with
the prior art as a whole.” Id.
We are not persuaded here because the combination of Abboud and
Kudaravalli does suggest the claimed invention. In particular, Abboud does
suggest changing flow rates based on information from the size detection
mechanism 56 and Kudaravalli teaches that flow rate information may “be
used for automatic shut down control” (FF 9). Thus, the person of ordinary
skill interested in controlling flow rates as suggested by Abboud would have
had reason to use that flow rate information for automatic shut down control
as taught by Kudaravalli, in order to maximize safety (FF 11) and control of
flow rates (FF 10).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Abboud and Kudaravalli render claim 1 obvious.
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SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Abboud and Kudaravalli. Claims 2—7 fall with
claim 1.
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
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