Ex Parte Willyard et al

Patent Trials and Appeals Board

Jan 15, 2019

13043665 - (D) (P.T.A.B. Jan. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/043,665
90039 7590
Covidien LP
Attn: IP Legal
5920 Longbow Drive
Mail Stop A36
03/09/2011
01/17/2019
Boulder, CO 80301-3299
FIRST NAMED INVENTOR
Richard A. Willyard
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
H-EB-00285 (1544-203) 9294
EXAMINER
HUPCZEY, JR, RONALD JAMES
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
01/17/2019 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):
mail@cdfslaw.com
rs. patents. two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHARD A. WILLY ARD and JOSEPH D. BRANNAN
Appeal 2018-002665
Application 13/043,665 1
Technology Center 3700
Before LINDA E. HORNER, MICHAEL J. FITZPATRICK, and
JILL D. HILL, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants seek our review under 35 U.S.C. § 134(a) of the
Examiner's rejections of claims 1-5, 7-9, 11, and 17-20, which are all of the
pending claims. Final Office Action (March 6, 2017) ("Final Act."). We
have jurisdiction under 35 U.S.C. § 6(b ).
1 Appellants identify Covidien LP, which is a wholly-owned subsidiary of
Medtronic PLC, as the real party in interest. Appeal Brief (August 14, 2017)
("Appeal Br."), at 2.
Appeal2018-002665
Application 13/043,665
The Examiner rejected the pending claims as unpatentable over
various combinations of the prior art. Appellants seek reversal of the
rejections because the Examiner relied on an unreasonably broad
interpretation of the claim language in order to find the claimed subject
matter in the prior art. For the reasons explained below, we agree with
Appellants that the Examiner's claim interpretation is unreasonably broad,
and that under the correct interpretation, the Examiner has not shown that
the prior art discloses the claimed subject matter. Thus, we REVERSE.
CLAIMED SUBJECT MATTER
The claimed subject matter relates to methods of directing energy to
tissue using electrosurgical devices including systems for thermal-feedback-
controlled rate of fluid flow to a fluid-cooled antenna assembly.
Specification (March 9, 2011) ,r 1. Claims 1 and 9 are independent. Claim
1, reproduced below with the disputed limitations italicized for emphasis, is
illustrative of the subject matter on appeal.
1. A method of directing energy to tissue by using a
fluid-cooled antenna assembly of an energy applicator, the
method comprising:
connecting the energy applicator to a hub, the hub coupled
to a coolant supply system for providing fluid to the antenna
assembly of the energy applicator, the coolant supply system
having a coolant source, a first coolant supply line, a second
coolant supply line, and a third coolant supply line in fluid
communication with the coolant source, the first coolant supply
line connected between the coolant source and a fluid-movement
device, the second coolant supply line directly connected
between a pressure transducer and the fluid-movement device,
and the third coolant supply line directly connected between a
flow-control device and the antenna assembly;
positioning the energy applicator in tissue;
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Application 13/043,665
activating the energy applicator via an electrosurgical
generator;
measuring a temperature of the fluid in the antenna
assembly;
controlling a thermal-feedback-controlled rate of fluid
flow based on the measured temperature of the fluid in the
antenna assembly;
providing fluid to the antenna assembly at the thermal-
feedback-controlled rate of fluid flow using a feedback control
system including the flow-control device, the flow control device
including a valve and an electro-mechanical actuator, and the
feedback control system including a processor unit; and
connecting the pressure transducer to the valve, the
pressure transducer disposed within the coolant supply system;
wherein the pressure transducer outputs a signal at a
pressure below a burst pressure of a pressure relief valve to
indicate to the electrosurgical generator that the fluid-cooled
antenna assembly has coolant flowing therethrough and wherein
the processor unit triggers a shut-off of the electrosurgical
generator based on pressure levels of the coolant in the fluid-
cooled antenna assembly; and
wherein the processor unit outputs a signal indicative of
an error code if a predetermined time elapses between energy
delivery to the fluid-cooled antenna assembly and detection of
the signal outputted by the pressure transducer.
Corrected Appeal Brief (September 14, 2017) at 19-20 (Claims Appendix).
EVIDENCE
Rudie us 5,300,099 Apr. 5, 1994
Eshel US 7,018,398 B2 Mar. 28, 2006
Gharib US 7,255,680 B 1 Aug. 14, 2007
Bek et al. US 7,422,587 B2 Sept. 9, 2008
Elmouelhi et al. US 2008/0269737 Al Oct. 30, 2008
Gellman US 2009/0082837 Al Mar. 26, 2009
Watson US 8,187,261 B2 May 29, 2012
Subramaniam US 8,702,693 B2 Apr. 22, 2014
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Application 13/043,665
REJECTIONS
The Final Office Action includes the following rejections:
1. Claims 1-3, 5, 9, 17, 19, and 20 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Bek, Watson, Elmouelhi, and
S ubramaniam.
2. Claim 4 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Bek, Watson, Elmouelhi, Subramaniam, and Eshel.
3. Claim 7 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Bek, Watson, Elmouelhi, Subramaniam, and Gellman.
4. Claims 8 and 11 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Bek, Watson, Elmouelhi, Subramaniam, and
Gharib.
5. Claim 18 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Bek, Watson, Elmouelhi, Subramaniam, and Rudie.
ANALYSIS
First Ground of Rejection
In the rejection of claim 1, the Examiner found that Bek discloses
substantially all of the recited method steps, including using a fluid-cooled
antenna assembly having a pressure transducer connected to a valve within a
coolant supply system. Final Act. 3--4. The Examiner found that Bek fails
to disclose, among other limitations, a shut-off function based on pressure
levels of the coolant and output of a signal indicative of an error code if a
predetermined time elapses between energy delivery and detection of the
signal outputted by the pressure transducer. Id. at 4-5. The Examiner found
that Elmouelhi teaches detecting flow issues using a pressure sensor and
performing a shut-off of ablation therapy in response to such issues. Id. at 6
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Application 13/043,665
( citing Ehnouelhi ,r,r 25, 28, 96). The Examiner determined that it would
have been obvious to use this shut-off functionality in Bek, and that in
providing such a combination, Bek's method would be modified to check
that fluid is flowing within the system by sensing the pressure after a given
amount of time from when the energy is delivered by the generator and, if an
issue exists, shutting off the generator. Id. (citing Elmouelhi ,r,r 31-36). The
Examiner made similar findings about the subject matter of independent
claim 9. Id. at 8-12.
Appellants argue that the Examiner erred in this first ground of
rejection because Elmouelhi does not describe issuing an error code based
on "the elapsing of a time period." Appeal Br. 9. Appellants assert that
checking fluid flow at some point after energy delivery to detect an error is
not equivalent to outputting an error code "if a predetermined amount of
time elapses between energy delivery and detection of a pressure transducer
signal." Id. at 10 (emphasis omitted). As an example, Appellants explain
that if Elmouelhi' s system checks fluid flow at time T after energy delivery
and does not detect a fluid problem, the system would not issue an error
signal, but if the system detects a fluid problem at time T, the system would
issue an error signal. Id. Appellants argue that this example shows that "the
error signal in Elmouelhi has nothing to do with elapse of time." Id. By
contrast, according to Appellants, the system of claim 1 would output an
error code if time period T elapses between energy delivery and detection of
a pressure transducer signal. Id.
The Examiner rejects Appellants' argument as based on an unduly
narrow interpretation of "predetermined time" because the disclosure "does
not give any insight as to how the time is 'predetermined', a specific start or
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Application 13/043,665
end point for the time that has 'elapsed', or if any specific amount is
required to elapse as the 'predetermined time' between the energy delivery
and detection." Examiner's Answer (November 17, 2017) ("Ans."), at 4.
The Examiner explains that "an amount of time ( a 'predetermined time')
would necessarily have to elapse between energy delivery and the detection
of a signal as in Elmoulhi [sic] by the pressure transducer before an error
code would be outputted by the processor unit." Id. at 5. The Examiner thus
interprets "predetermined time" as "the time between energy delivery and
the detection of a signal by the pressure transducer indicative of an error
within the fluid system." Id.
Appellants reply that the Examiner's interpretation of "predetermined
time" as referring to the elapse of any amount of time is unreasonably broad
because it "reads the word 'predetermined' out of the claims." Reply Brief
(January 17, 2018) ("Reply Br."), at 2.
We look to Appellant's Specification to discern the broadest
reasonable interpretation of "predetermined time" as that phrase would be
understood by one of ordinary skill in the art in light of the Specification.
See Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (en bane)
(The Office "determines the scope of claims ... not solely on the basis of
the claim language, but upon giving claims their broadest reasonable
construction 'in light of the specification as it would be interpreted by one of
ordinary skill in the art."') (quoting In re Am. Acad. of Sci. Tech Ctr., 367
F.3d 1359, 1364 (Fed. Cir. 2004)). Appellants' Specification describes that
processor unit 82 may be configured to output a signal indicative of an error
code "if a certain amount of time elapses between the point at which energy
delivery to the probe 100 is enabled and when the pressure signal is
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detected, e.g., to ensure that the fluid-movement device 60 is turned on
and/or that the probe 100 is receiving flow of fluid before the antenna
assembly 112 can be activated." Spec. ,r 51. We understand this description
to mean that the system senses a pressure signal, at predetermined elapsed
time T after enabling delivery of energy to probe 100, and issues an error
code if no pressure signal is sensed at this predetermined time. In other
words, the system infers a problem with fluid-movement device 60 and/or
flow control device 50 if pressure sensor 70 does not detect fluid flow at a
predetermined elapsed time after enabling delivery of energy to the probe.
The Specification further describes this self-check as follows:
Electrosurgical system 10 may be adapted to override PWM
control of the flow-control device 50 to hold the valve 52 open
upon initial activation of the antenna assembly 112. For this
purpose, a timer may be utilized to prevent the control device
50 from operating for a predetermined time interval ( e.g., about
one minute) after the antenna assembly 112 has been activated.
In some embodiments, the predetermined time interval to
override PWM control of the flow-control device 50 may be
varied depending on setting, e.g., time and power settings,
provided by the user. In some embodiments, the electrosurgical
power generating source 28 may be adapted to perform a self-
check routine that includes determination that the flow-control
device 50 is open before enabling energy delivery between the
electrosurgical power generating source 28 and the probe 100.
Id. ,r 74. Because pressure sensor 70 resides between fluid movement device
60 and flow control device 50 and downstream of pressure relief valve, if
fluid movement device 60 were operating and flow control device 50 were
not opened, pressure sensor 70 would not sense a pressure signal below burst
pressure after an elapsed predetermined time because once the pressure rises
above a burst pressure of the pressure relief valve, the pressure relief valve
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Application 13/043,665
would open and allow the fluid from fluid movement device 60 to bypass
pressure transducer 70. As claimed, if after a predetermined time elapses
from energy delivery, pressure transducer has not outputted a signal at a
pressure below a burst pressure of a pressure relief valve, then the system is
programmed to infer that fluid is not reaching the antenna assembly, either
because fluid movement device 60 is not turned on or because flow control
device 50 is not open.
Thus, Appellants' Specification provides an example in which the
valve of the flow control device is opened for a predetermined time period
( e.g., one minute) after delivery of energy to the device to ensure that fluid is
flowing properly to the fluid-cooled antenna assembly. We interpret
"predetermined time" in light of the description in the Specification to mean
a preset amount of time, such that the system looks for an error after a preset
amount of time elapses after delivery of energy to the device. Contrary to
the Examiner's position, Appellants' Specification explains generally how
this predetermined time is set. Spec. ,r 7 4 ( describing that the predetermined
time that the valve remains open for conducting the self-test may be varied
depending on time and power settings provided by the user). We agree with
Appellants that the Examiner's interpretation of "predetermined time" to
encompass any amount of time after delivery of energy to the device is
unreasonably broad in light of the claim language itself and the description
provided in Appellants' Specification.
Turning to the prior art, Elmouelhi does not teach taking a
predetermined elapsed time into account in determining if an error has
occurred. Elmouelhi' s system uses a sensor to measure actual flow rate of a
cooling fluid to a patient via a catheter. Elmouelhi ,r,r 33, 34. Elmouelhi
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describes that the sensor may be positioned between a generator (e.g., fluid
pump) and the target tissue and may detect the pressure of the fluid as it
flows through a tube. Id. ,r 34. Elmouelhi describes that a low pressure
reading may indicate for example that the fluid pump is malfunctioning, and
in such case, the generator may provide an error message. Id. Elmouelhi
describes that "[i]n some embodiments, the therapy delivered to patient 12 is
automatically stopped in response to an irregular pressure reading." Id.
Although Elmouelhi' s system checks to see if the appropriate amount
of cooling fluid is flowing through the system, it performs this check
differently from the manner claimed. Elmouelhi does not take into account
whether a predetermined time has elapsed between energy delivery to
system and detection of a signal from a pressure transducer. Rather,
Elmouelhi' s sensor tests continuously for a pressure that fails to match the
expected pressure at the target flow rate. Elmouelhi ,r 3 6 ("In some
embodiments, the sensor provides constant feedback to generator 14 and
adjustments to the therapy parameters are made based on that feedback").
For this reason, we find that the Examiner based the rejection on an
unreasonably broad interpretation of the claim language to find that the prior
art discloses all the limitations of the independent claims. Thus, we do not
sustain the rejection of independent claims 1 and 9, and their dependent
claims 2, 3, 5, 17, 19, and 20, as unpatentable over Bek, Watson, Elmouelhi,
and Subramaniam.
Second through Fifth Grounds of Rejection
The remaining grounds of rejection of dependent claims 4, 7, 8, 11,
and 18 depend on the same erroneous claim interpretation of independent
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claims 1 and 9. Thus, for the same reasons discussed above, we also do not
sustain the second through fifth grounds of rejection.
DECISION
The decision of the Examiner rejecting claims 1-5, 7-9, 11, and 17-
20 is reversed.
REVERSED
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