Ex Parte Petrie et al

Patent Trial and Appeal Board

Jan 23, 2018

13532050 (P.T.A.B. Jan. 23, 2018)

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.
13/532,050 06/25/2012 Aidan Petrie 10124/04006 2708
104919 7590 01/25/2018
Fay Kaplun & Marcin, LLP — BSC
150 Broadway, suite 702
New York, NY 10038
EXAMINER
KIM, EUN HWA
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
01/25/2018 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):
okaplun@fkmiplaw.com
fkmiplaw @ yahoo. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AID AN PETRIE, ANDREW W. MARSELLA,
DANIEL NELSEN, DAVID ROBSON, and JOSEPH M. GORDON
Appeal 2017-001939
Application 13/532,050
Technology Center 3700
Before JEFFREY N. FREDMAN, ELIZABETH A. LaVIER, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a device
for thermal ablation. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
Statement of the Case
Background
“Excessive or dysfunctional uterine bleeding often arises from a
hormonal imbalance, a systemic disease or anatomical abnormality such as
fibroids, polyps or other growths” (Spec. ^ 2). “In hydro-thermal ablation
1 Appellants identify the real party in interest as Boston Scientific Scimed,
Inc. (see App. Br. 2).
Appeal 2017-001939
Application 13/532,050
(HTA), heated saline solution is applied against targeted portions of the
endometrial lining through a hysteroscope inserted through the cervix” {id.
3). “The users of conventional ablation devices must monitor pressure and
temperature of the saline and the status of surgical tools used, increasing the
complexity and cost of the procedures” {id. ^ 4).
“The present invention also relates to a control system for an hydro-
thermal ablation procedure. . . . including a processor monitoring and
controlling the hydro-thermal ablation procedure ... A mechanical safety
interlock of the processor inhibits the hydro-thermal ablation procedure
when commanded by the processor” (Spec. ^ 6).
The Claims
Claims 26^45 are on appeal. Claim 26 is representative and reads as
follows:
26. A device for thermal ablation, comprising:
a sensor arrangement sensing data corresponding to an
operation condition of the device;
a reusable console;
a disposable cartridge removably attached to the console,
the cartridge including a fluid path through which ablation fluid
flows and a heater for heating the ablation fluid to a target
temperature;
a control unit connected to the sensor arrangement, the
control unit controlling operation of the heater in response to
data from the sensor arrangement to control operation of the
device to a safe mode to prevent injury to a patient when data
from the sensor arrangement is outside a predetermined range;
and
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Application 13/532,050
a hardware safety subsystem connected to the sensor
arrangement and providing a redundant fail safe operation to
place the device in the safe mode in the event of a failure of the
control unit to do so when data from the sensor arrangement is
outside the predetermined range.
The Issues
A. The Examiner rejected claims 26, 29-35, 38, 39, and 41 under 35
U.S.C. § 103(a) as obvious over Cioanta,2 Masterson,3 and Guziak4 (Final
Act. 3-8).
B. The Examiner rejected claims 27, 36, and 42 under 35 U.S.C. § 103(a)
as obvious over Cioanta, Masterson, Guziak, and Howson5 (Final Act. 8-10,
13-15).
C. The Examiner rejected claim 28 under 35 U.S.C. § 103(a) as obvious
over Cioanta, Masterson, Guziak, and Malackowski6 (Final Act. 10-11).
D. The Examiner rejected claims 37 and 44 under 35 U.S.C. § 103(a) as
obvious over Cioanta, Masterson, Guziak, and Farra7 (Final Act. 11-12, 18-
19).
E. The Examiner rejected claim 40 under 35 U.S.C. § 103(a) as obvious
over Cioanta, Masterson, Guziak, and Tenczar8 (Final Act. 12-13).
F. The Examiner rejected claims 43 and 45 under 35 U.S.C. § 103(a) as
obvious over Cioanta, Masterson, and Farra (Final Act. 15-18).
2 Cioanta et al., US 2004/0267340 Al, published Dec. 30, 2004.
3 Masterson et al., US 5,891,094, issued Apr. 6, 1999.
4 Guziak et al., US 4,726,024, issued Feb. 16, 1988.
5 Howson, US 4,676,776, issued June 30, 1987.
6 Malackowski, US 2006/0073048 Al, published Apr. 6, 2006.
7 Farra et al., US 5,746,719, issued May 5, 1998.
8 Tenczar, US 4,022,205, issued May 10, 1977.
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Application 13/532,050
A. 35 U.S.C. § 103(a) over Cioanta, Masterson, and Guziak
The Examiner finds Cioanta teaches a thermal ablation device
comprising a sensor, a reusable console, a disposable cartridge, and a control
unit (see Final Act. 3). The Examiner finds Masterson teaches a thermal
ablation device with a “control unit controlling operation of a heater in
response to data from the sensor arrangement to control operation of the
device to a safe mode to prevent injury to a patient when data from the
sensor arrangement is outside a predetermined range” (Final Act. 4).
The Examiner acknowledges that Cioanta and Masterson do not teach
“a hardware safety subsystem connected to the sensor arrangement and
providing a redundant fail safe operation to place the device in the safe mode
in the event of a failure of the control unit to do so when data from the
sensor arrangement is outside the predetermined range” (Final Act. 4).
The Examiner finds Guziak teaches:
a hardware safety subsystem connected to various components
of a device including control unit (a processor, a
microprocessor with computer software) and peripheral
devices/interface circuits (e.g. sensors) and providing a
redundant fail safe operation to place the device in a safe mode
in the event of a failure of the control unit to do so.
(Final Act. 4-5).
The Examiner finds it obvious to “have modified the device of
Cioanta/Masterson combination to incorporate the hardware safety
subsystem [of Guziak because it] . . . would provide an additional safety
measure to the thermal ablation device” (Final Act. 5).
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Application 13/532,050
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the safety system of Guziak is
analogous art to the thermal ablation devices of Cioanta and Masterson?
Findings of Fact
1. Cioanta teaches “thermal treatment systems have used various
heating sources to generate the heat necessary to treat or ablate the targeted
tissue. For example, laser, microwave, and radio-frequency (RF) energy
sources have been proposed to produce the heat which is then directed to the
targeted tissue” (Cioanta ^ 3).
2. Figure 2 of Cioanta is reproduced below:
“FIG. 2 illustrates the catheter assembly 20 mounted to the control console
30. In this embodiment, the rear primary source 20p of the cassette 20
mounts to a front surface mount portion 30m of the control console 30”
(Cioanta ^ 79).
3. Cioanta teaches “computer program code for . . . automatically
adjusting the temperature to desired operational temperatures” (Cioanta
1134).
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4. Figure 16 of Masterson is reproduced below:
FIG. 16.
“FIG. 16 illustrates an exemplary system for thermally treating a hollow
body organ according to the invention” (Masterson 9:22-23).
5. Masterson teaches “controller 170 may be provided with a
variety of alarms to indicate abnormal operating conditions, such as over or
under temperature ... In the event that certain conditions are detected,
controller 170 is configured to cease operation of device 162 to provide
increased safety to the patient” (Masterson 18:52-59).
6. Guziak teaches: “The present invention relates to fail safe
architecture for a computer system and also to the fail safe operation of
the computer system” (Guziak 3:11-13).
7. Guziak teaches “the architecture utilizes closed loop detection
to ensure that, if a component fails, the computer system is placed in a
restrictive mode of operation or is disabled to ensure that the failure will not
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Application 13/532,050
affect the environment within which the computer system is operating”
(Guziak 3:15-20).
8. Guziak teaches the “fail safe architecture described herein is
applicable to a wide range of computer systems” (Guziak 3:34-35).
Principles of Law
“Prior art is analogous if it is from the same field of endeavor or if it is
reasonably pertinent to the particular problem the inventor is trying to
solve.” Circuit Check Inc. v. QXQInc., 795 F.3d 1331, 1335 (Fed. Cir.
2015). “The question is not whether simple concepts ... are within the
knowledge of lay people or even within the knowledge of a person of
ordinary skill in the art. Rather, the question is whether an inventor would
look to this particular art to solve the particular problem at hand.” Id-
Analysis
Appellants contend “Guziak is not from the same field of endeavor”
and “Guziak would not logically commend itself to an inventor’s attention.
In particular, claim 26 and Guziak are not directed to the same problem nor
do they serve the same purpose” (App. Br. 6-7). Appellants specifically
contend:
an inventor considering the problem of how to more easily
monitor and integrate an HTA [hydro-thermal ablation] system
to prevent harm to a patient would not have been motivated to
have considered Guziak, since Guziak does not relate to HTA
systems, medical components, or medical procedures in any
way and is merely directed to temporar[]ily controlling or
limiting the performance of a computer system to prevent faulty
computer operation.
(App. Br. 8).
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Application 13/532,050
The Examiner responds “Guziak explicitly discloses that the term
‘computer system’ refers to any type of apparatus” (Ans. 13). The Examiner
finds:
one of ordinary skill in the art would find Guziak to be an
analogous art since Guziak discloses a fail safe architecture
within a computer system that is able to detect when the control
unit/microprocessor or any components of the computer system
does not operate correctly and responds to the fault condition
by placing the control unit/microprocessor in a restrictive mode
of operation or is disabled to eliminate hazardous effects of
component failure.
(Ans. 13-14).
We agree with Appellants that Guziak is neither in the same field of
endeavor as Cioanta and Masterson, nor pertinent to those problems with
which the Specification or Cioanta and Masterson were concerned (see App.
Br. 7-8).
In particular, the Specification teaches two different components of
the thermal ablation unit separately monitor temperature including a data
channel 340 that communicates with a procedure controller 312 (Spec. ^ 23)
while at “the same time, the hardware safety subsystem 314 is used to also
monitor ‘pressure ok’ and ‘temperature ok’ signals generated by the
disposable procedure set 400, to provide a redundant fail safe operation in
case of a leak or other problem during the procedure” (Spec. ^ 24). Thus,
the problem with which the Specification was concerned was to provide a
redundant fail safe for temperature control along with the standard computer
temperature control in a medical thermal ablation device.
Cioanta was concerned with monitoring temperature in a thermal
ablation device using a computer controller (FF 3) and Masterson also
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Application 13/532,050
teaches a controller that monitors temperature in thermal ablation devices
(FF 5).
In contrast, Guziak teaches neither temperature control nor thermal
ablation devices, but rather is generally drawn to “fail safe architecture for a
computer system” (FF 6).
When considering whether a reference is pertinent to the problem with
which the inventor or prior art were concerned, the framing of the problem
may well be determinative of the analogous art determination. If the
problem is broadly framed as the desire to improve safety generally, then
Guziak is generally relevant to any device from any endeavor. However,
this broad a framing is unreasonable, because under this logic any reference
dealing with a general concern will always be pertinent.
When the problem is framed at a more reasonable scale, whether
narrowly as reducing the risk of burning patients during ablation with the
thermal ablation unit as Masterson suggests (FF 5), or more broadly as
making medical therapy devices safer by limiting extreme temperature,
pressure, or other conditions, Guziak lacks any indicia of relevance to these
fields of endeavor.
We are not persuaded by the Examiner’s finding that “the purpose of
the hardware safety subsystem is to prevent/suspend operation of output
devices when the control unit fails to detect fault conditions or simply, when
the control unit does not operate properly” (Ans. 13; emphasis omitted).
Certainly Masterson teaches to cease operation when over-temperature or
other conditions occur (FF 5), but Guziak is not analogous art that provides
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reasons for an additional, redundant safety system based on computer system
architecture into the medical devices of Cioanta or Masterson.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the safety system of Guziak is analogous art to the thermal ablation
devices of Cioanta and Masterson. Accordingly, we reverse the rejection of
claims 26.
B.—E. 35 U.S.C. § 103(a) rejections
These rejections rely upon the underlying obviousness rejection over
Cioanta, Masterson, and Guziak. Having reversed the rejection of claim 26,
we also necessarily reverse these obviousness rejections because the
Examiner does not identify where Howson, Malackowski, or Tenczar
suggest a hardware safety subsystem as required by claims 26, 42, and 44.
F. 35 U.S.C. § 103(a) over Cioanta, Masterson, and Farr a
The Examiner finds Cioanta teaches each element of claim 43 except
a “first microcontroller placing the system in a safe mode of operation when
data from the sensor arrangement is outside a predetermined range” (Final
Act. 16) and “wherein a pump impeller is provided in the disposable
cartridge” {id. at 17). The Examiner finds Masterson teaches a
“microcontroller controlling operation of the system and placing the system
in a safe mode of operation when data from the sensor arrangement is
outside a predetermined range” {id at 16.). The Examiner finds Farra
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teaches “a disposable cartridge (disposable cartridge 52 in Fig. 2 comprising
a pump impeller[)]” {id. at 17).
The Examiner finds it obvious to “have modified the first
microcontroller of Cioanta to incorporate the teaching of Masterson so that
the microcontroller is configured to cease operation of the system and alert
the user of abnormal operating conditions, such as over or under temperature
. . . thereby ensuring safety of the patient” (Final Act. 16). The Examiner
also finds it obvious “to incorporate a pump impeller in the disposable
cartridge and a motor within the console so that the pump is disposable after
use and does not need to be sterilized when it is exposed to bodily fluids”
{id. at 17).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the combination of Cioanta,
Masterson, and Farra renders claims 43 and 45 obvious?
Findings of Fact
9. Farra teaches:
during a surgical or other medical procedure, various bodily
fluids may need to be delivered to and withdrawn from a
patient. A pumping device used for this purpose will obviously
be exposed to these fluids. Following the procedure, the
pumping device and other exposed system components will
either have to be discarded or, in some way, sanitized.
(Farra 1:21-26).
10. Farra teaches a “versatile and cost effective fluid flow control
system” that comprises “a disposable cartridge defined by a housing within
which is mounted a pump and a pressure transducer element” (Farra 2:10-
16).
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Application 13/532,050
Principles of Law
“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).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 15-18; FF 1-5, 9, 10) and
agree that claims 43 and 45 are obvious over Cioanta, Masterson, and Farra.
We address Appellants’ arguments below.
Appellants contend:
Claim 43 recites limitations substantially similar to those of
claim 26. As described above, Cioanta, Masterson, and Ferra
do not disclose or suggest the above recitation of claim 26.
Thus, Cioanta, Masterson, and Ferra, taken alone or in any
combination, do not disclose or suggest the above recitation of
claim 43 for at least the reasons described above with regard to
claim 26. Because claim 45 depends from and includes the
limitations of claim 43, it is respectfully submitted that this
claim is also allowable.
(App. Br. 17).
We find this argument unpersuasive because claim 43 lacks the
central argued limitations of claim 26 that require both a “control unit... to
control operation of the device to a safe mode to prevent injury” and “a
hardware safety subsystem . . . providing a redundant fail safe operation to
place the device in the safe mode in the event of a failure of the control
unit.” That is, claim 26 requires two different safety systems, a “control
unit” and a “hardware safety subsystem”. In contrast, claim 43 only requires
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a single “microcontroller” that has the capacity to place the “system in a safe
mode of operation.”
As the Examiner finds, Cioanta teaches a thermal ablation system
with a temperature controller (FF 3) and Masterson specifically suggests, in
the thermal ablation system context, that “controller 170 is configured to
cease operation of device 162 to provide increased safety to the patient” (FF
5). Thus, we agree with the Examiner that Cioanta and Masterson render
obvious the use of a single computer based controller to place a system in a
safe mode of operation (see, e.g., Ans. 10, 16).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
combination of Cioanta, Masterson, and Farra renders claims 43 and 45
obvious.
SUMMARY
In summary, we reverse the rejection of
• claims 26, 29-35, 38, 39, and 41 under 35 U.S.C. § 103(a) as
obvious over Cioanta, Masterson, and Guziak;
• claims 27, 36, and 42 under 35 U.S.C. § 103(a) as obvious over
Cioanta, Masterson, Guziak, and Howson;
• claim 28 under 35 U.S.C. § 103(a) as obvious over Cioanta,
Masterson, Guziak, and Malackowski;
• claims 37 and 44 under 35 U.S.C. § 103(a) as obvious over
Cioanta, Masterson, Guziak, and Farra; and
• claim 40 under 35 U.S.C. § 103(a) as obvious over Cioanta,
Masterson, Guziak, and Tenczar.
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Application 13/532,050
We affirm the rejection of claims 43 and 45 under 35 U.S.C. § 103(a)
as obvious over Cioanta, Masterson, and Farra.
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-IN-PART
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