Ex Parte Peterson et al

Patent Trial and Appeal Board

May 17, 2018

13839859 (P.T.A.B. May. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/839,859 03/15/2013
126679 7590 05/21/2018
Lane Powell, PC
601 S.W. Second Avenue
Suite 2100
Portland, OR 97204
FIRST NAMED INVENTOR
Ken Peterson
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.
130424.008403 3497
EXAMINER
PIA TES KI, ERIN M
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
05/21/2018 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):
physio_control_docketing@cardinal-ip.com
IPMail.MedSurgGroup@stryker.com
patents@lanepowell.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KEN PETERSON, MITCHELL A. SMITH,
DENNY CRAIG EDWARDS, JEFFERY SCOTT EDWARDS,
PABLO GONZALEZ-GANDOLFI, ROCKLAND W. NORDNESS,
MATTHEW LAWRENCE BIELSTEIN, CLAYTON MING YOUNG,
DAVID B. STEWART, PAUL R. JUHASZ, DAVID OKEY,
STEVEN WITTERS, and IRA M. TURNER
Appeal2017-004605 1
Application 13/839,859
Technology Center 3700
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to an external
defibrillator. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b)(l).
We reverse.
1 Appellants state that the "real party in interest is Physio-Control, Inc., as
evidenced by an assignment recorded June 20, 2013 in the U.S. Patent and
Trademark Office at Reel 030649, Frame 0362" Appeal Br. 1.
Appeal2017-004605
Application 13/839,859
STATEMENT OF THE CASE
Appellants' invention is directed a defibrillator having "two
processors for enhancing the defibrillation process. A first processor is
dedicated to controlling when an electrical charge is applied to a patient. A
second processor is dedicated to data operations for enhancing the
monitoring and diagnostic capability, interventional treatment capability,
and the coaching capability of the de fibrillation process." Spec. i-f 17. 2
The Specification explains that the second processor "is in
communication with one or more external devices for transmission and
receipt of network data for further enhancing the coaching process. The
second processor allows the defibrillator to be maintained with updated
network data and software and the one or more external devices with
updated defibrillator data." Id.
Claims 38 and 85 are the independent claims on appeal, and read as
follows:
38. An external defibrillator comprising:
a defibrillator processor module for storing and applying
an electrical charge for defibrillating a patient, the defibrillator
processor module including a defibrillator processor for
controlling when the electrical charge is applied for
defibrillating a patient;
and a data processor module configured to control
operations not essential for the survival of the patient, the data
2 We herein refer to the Specification, filed Mar. 15, 2013 ("Spec."); Final
Office Action, mailed Dec. 16, 2015 ("Final Act."); Corrected Appeal Brief,
filed Oct. 10, 2016 ("Corrected Appeal Br."); and the Examiner's Answer,
mailed Nov. 29, 2016 ("Ans."). A Reply Brief was filed on Jan. 27, 2017
but it is not cited in this Decision.
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processor module including a data processor separate from the
defibrillator processor,
wherein the defibrillator processor is isolated in its
processing from the processing done by the data processor, and
wherein the data processor is configured to provide
redundancy control in the event of a malfunction of the
defibrillator processor.
85. An external defibrillator comprising:
a defibrillator processor module for storing and applying
an electrical charge for defibrillating a patient, the defibrillator
processor module including a defibrillator processor for
controlling when the electrical charge is applied for
defibrillating a patient; and
a data processor module, including a data processor
separate from the defibrillator processor configured to control
operations not essential for the survival of the patient, the data
processor module executing an event service that provides for
scheduled downloading of data from the defibrillator to an
external computing device using the data processor module as
a proxy,
wherein the defibrillator processor is isolated in its
processing from the processing done by the data processor.
Corrected Appeal Br. 2, 11 (emphasis added to illustrate claim limitations at
issue).
The Examiner entered eleven grounds of rejection for obviousness.
See Ans. 2-25. Of those eleven grounds, independent claims 38 and 85,
reproduced above, are included in the following two rejections:
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Application 13/839,859
(1) Claims 38, 39, 51-53, 56, and 91, under 35 U.S.C. § 103(a) as
being unpatentable over Banville3 and Neumiller4 (Final Act. 2-10; Ans. 2-
10); and
(2) Claims 85-89 and 93, under 35 U.S.C. § 103(a) as being
unpatentable over Banville, Neumiller, and Dicks5 (Final Act. 21-25; Ans.
21-25).
STANDARD OF REVIEW
As stated in Jn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
OBVIOUSNESS-BANVILLE AND NEUMILLER
The Examiner's Prima Facie Case
In rejecting independent claim 38 over Banville and Neumiller, the
Examiner cited Banville as describing a defibrillator that differs from claim
38's defibrillator in that Banville's defibrillator has a single processor,
"processor 64," that controls not only the storage and application of the
defibrillating electrical charge, but also controls data processing functions,
such as providing information to coach the user how to apply the
defibrillating electrical charge. Ans. 3.
3 US 2006/0173498 Al (published Aug. 3, 2006).
4 US 2003/0140274 Al (published Jul. 24, 2003).
5 US 2011/0179405 Al (published Jul. 21, 2011).
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The Examiner cited Neumiller as teaching that "it is common in the
art for the various control modules of a defibrillator such as an external
defibrillator ... to have separate processors ... ; since they are separate, they
are isolated in their processing from one another" as recited in Appellants'
claim 38. Id. at 4 (citing Neumiller i-fi-f 15, 22).
Based on the references' combined teachings, the Examiner
concluded that it would have been obvious to modify Banville' s device
according to the teachings in Neumiller,
Id.
and to have the data processor (a user interface module in
Neumiller's teachings) as an isolated and separate processor
from the defibrillator processor (a therapy control module in
Neumiller's teachings), in which the data processor may control
the defibrillation processor in order that each processor should
be able to be separately managed to ensure it is operating
correctly, as taught by Neumiller in i1 [0022], and to incorporate
other data into control of the defibrillation processor, such as
patient parameters (Fig. 1, patient parameters module 22 is also
interconnected).
The Examiner conceded that Banville also differs from Appellants'
claim 3 8 in that Banville' s defibrillator does not meet claim 3 8 's
requirement for the data processor to be configured to provide redundancy
control in the event of a malfunction of the defibrillator processor. Id. at 5.
The Examiner cited paragraphs 5 and 84 of Banville as evidence that
that it would have been obvious to modify Banville's device to have the
redundancy control feature recited in claim 38. Id. The Examiner reasoned
further:
It would further have been obvious to one having
ordinary skill in the art to utilize this capability of one processor
controlling another or directing another to provide therapy in
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the event of a malfunction of the defibrillator processor (for
example if the defibrillator processor erroneously decides not to
provide necessary therapy), to provide redundancy control to
protect the health of the patient in the event of a failure of the
processor providing defibrillation. In the present case,
particularly since Banville teaches a single chip, it would have
been obvious to one having ordinary skill in the art that since a
single chip is capable of handling both data processing and
defibrillation functions, that two chips may be used with
equivalent capabilities, and one may take over to provide both
functions in the case that the other no longer functions
correctly. Neumiller additionally teaches that the data control
processor sends data to a defibrillation processor, including
control and data signals; it would further have been obvious to
one having ordinary skill in the art that these control and data
signals could be extended to include full control of the
secondary processor. It would further have been obvious to one
having ordinary skill in the art that if there are two processors,
one of which can control the other, that one processor may
serve as a redundant backup for the other in the case of failure,
particularly in a healthcare application, where the failure of a
processor could mean the death of a patient.
Id. at 6.
Analysis
In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007),
although the Supreme Court emphasized "an expansive and flexible
approach" to the obviousness question, id. at 415, the Court also reaffirmed
the importance of determining "whether there was an apparent reason to
combine the known elements in the fashion claimed by the patent at issue."
Id. at 418 (emphasis added).
Thus, the "mere fact that the prior art may be modified in the manner
suggested by the Examiner does not make the modification obvious unless
the prior art suggested the desirability of the modification." In re Fritch,
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972 F.2d 1260, 1266 (Fed. Cir. 1992). Moreover, "[i]t is impermissible to
use the claimed invention as an instruction manual or 'template' to piece
together the teachings of the prior art so that the claimed invention is
rendered obvious." Id.
Ultimately, therefore, "[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
199 5) (internal quotations omitted).
In the present case, having carefully considered the arguments and
evidence advanced by Appellants and the Examiner, Appellants persuade us
that the Examiner has not shown by a preponderance of the evidence that the
cited references would have rendered obvious the device recited in claim 38.
In particular, we are not persuaded that the Examiner has explained
adequately why, in the absence of impermissible hindsight, the combination
of Banville and Neumiller would have suggested to an ordinary artisan an
external defibrillator having processing-isolated data and defibrillator
processors, in which the data processor is configured to provide redundancy
control in the event of a malfunction of the defibrillator processor, as recited
in claim 3 8.
Banville discloses an external defibrillator that communicates
wirelessly with an implanted medical device (IMD). Banville, abstract.
Banville explains that wireless communication allows the IMD to provide
useful medical information regarding the patient to the operator of the
defibrillator. Id.
Paragraph 5 of Banville, cited by the Examiner, explains further:
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[T]he external defibrillator may receive information from the
IMD, prompt a user based on information received from the
IMD, deliver therapy based on information received from the
IMD, control delivery of therapy by the IMD, and store
information within the IMD. Through communication with an
IMD according to the invention, an external defibrillator may
provide more effective treatment to a patient in which the IMD
is implanted, and may more effectively manage medical
information than is possible with conventional defibrillators
that are incapable of communicating with IMDs.
Id. ii 5.
Paragraph 84 of Banville, also cited by the Examiner, provides
examples of how the information transmitted from the IMD to the
defibrillator can affect the treatment administered by the defibrillator:
For example, IMD 14 may apply arrhythmia detection
algorithms to the rhythm of heart 22 that distinguish between
ventricular and supra-ventricular arrhythmias. IMD 14 may
decide that a defibrillation pulse should be delivered in
response to detection of a ventricular arrhythmia, and that a
defibrillation pulse should not be delivered in response to
detection of a supra-ventricular arrhythmia. [Defibrillator
p ]rocessor 64 may control delivery of a defibrillation pulse to
patient 16 based on a defibrillation pulse delivery decision
received from IMD 14. In this manner, external defibrillator 12
may, for example, avoid delivering a defibrillation pulse to treat
a supra-ventricular arrhythmia. In some embodiments, a user
may override a decision by [defibrillator] processor 64 not to
deliver therapy based on information received from IMD 14,
and direct defibrillator 12 to deliver therapy.
Id. ii 84.
We agree with the Examiner that these teachings show that Banville' s
defibrillator processor can be influenced by devices external to the
defibrillator, the IMD processor specifically, to perform (or not perform)
certain actions. We are not persuaded, however, that the capability of
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Banville's defibrillator processor to be influenced by external devices
explains with adequate specificity how or why an ordinary artisan would
have configured Banville's defibrillator device to have the
malfunction-addressing processor configuration recited in Appellants' claim
38, even considering Banville alongside the relevant teachings in Neumiller.
We acknowledge Neumiller's teaching that external defibrillators, like
those described in Banville, can have multiple processors that independently
control multiple functions, including the defibrillator charge delivery
function. See Neumiller i-f 16 ("System controller 18 may be implemented as
a microprocessor that communicates control and data signals with other
components of medical device 12 . .. , such as therapy control module 14 or
other therapy modules, a patient parameters module 22, and a user interface
module 24."); id. i-f 17 ("For example, if medical device 12 is an AED
[automated external defibrillator], therapy control module 14 causes
defibrillator electrodes to deliver electric shocks to patient 16 in response to
control signals received from system controller 18 .... "); id. i-f 22 ("Each of
therapy control module 14, system controller 18, patient parameters module
22, and user interface module 24 may incorporate a processor to govern its
operations.").
In contrast to the configuration of Appellants' claim 38, in which the
data processor provides redundancy control in the event of defibrillator
processor malfunction, Neumiller's device uses "watchdog timers" to ensure
its various processors are not malfunctioning. Id. i-f 22 ("[T]he operation of
therapy control module 14, system controller 18, patient parameters module
22, and user interface module 24 may be governed by watchdog timers.
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Each watchdog timer requires a handshake at a prescribed time to validate
proper operation of the processor of its associated module.").
More specifically, Neumiller's watchdog timers determine whether
the various processors are functioning correctly, and if a processor is
determined to be malfunctioning, the watchdog timer resets the
malfunctioning processor:
The processors contain watchdog timer process managers that
verify that the expected processes have performed normally by
examining whether the processes have properly "checked in"
during a particular time interval. If the processes have properly
checked in during the prescribed time interval, a confirmation
or handshake signal is output to the watchdog timer. If the
watchdog timer does not detect the handshake signal within
the prescribed time, the watchdog timer places the processor
in a reset state to reinitialize the processor to a known safe
state. In addition, the watchdog timer may inhibit therapy
control module 14 from inadvertently delivering an electrical
shock to the patient via defibrillator electrodes.
Id. (emphasis added).
Thus, rather than teaching or suggesting the configuration in
Appellants' claim 38, in which the data processor provides redundancy
control in the event of defibrillator processor malfunction, Neumiller's
device is configured such that, when defibrillator processor malfunction is
detected, the defibrillator processor is simply reset to a safe initialized state.
Accordingly, although we acknowledge Banville's teaching that its
defibrillator processor can be influenced by external devices to perform (or
not perform) certain actions, we are not persuaded that, when the references'
teachings are viewed alongside each other, Neumiller's teaching of resetting
the defibrillator processor in the event of a malfunction would have
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suggested modifying Banville' s device to have the specific processor
configuration required by Appellants' claim 38.
We acknowledge the Examiner's contention that obviousness "may be
established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or
motivation to do so found either in the references themselves or in the
knowledge generally available to one of ordinary skill in the art." Ans. 28
(citing In re Fine, 837 F.2d 1071 (Fed. Cir. 1988); In re Jones, 958 F.2d 347
(Fed Cir 1992); KSR, 550 U.S. 398).
We acknowledge the Examiner's assertion, in that regard, that
"backups are a well-known method of ensuring the continued functionality
of a vital health device (such as the communications capability of the
[device] in the event that part of the health maintenance device fails[)]." Id.
We are not persuaded, however. Our reviewing court recently
reversed conclusions of obviousness made by this Board where, as here, the
proponent of obviousness relied on ordinary creativity and/or common sense
to establish the obviousness of a claim element missing from the prior art.
See DSS Tech. Mgmt., Inc. v. Apple Inc., 885 F.3d 1367 (Fed. Cir. 2018); see
also Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355 (Fed. Cir. 2016).
In DSS, the court explained that ordinary creativity and/or common
sense may be used to supply a missing claim element only when the missing
element is "unusually simple and the technology particularly
straightforward." 885 F.3d at 1374 (quotingArendi, 832 F.3d at 1362).
The court explained further that ordinary creativity and/or common
sense "cannot be used as a wholesale substitute for reasoned analysis and
evidentiary support, especially when dealing with a limitation missing from
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the prior art references specified." Id.; see also id. at 1374--75 ("In cases in
which 'common sense' is used to supply a missing limitation, as distinct
from a motivation to combine, ... our search for a reasoned basis for resort
to common sense must be searching.") (quoting Arendi, 832 F .3d at 1363).
In the present case, it might be true that the general concept of
backups was well known in this art for ensuring proper device function in
the event of a malfunction of a component. We are not persuaded, however,
that the multi-processor devices described in Banville and Neumiller are
unusually simple or straightforward. The Examiner, moreover, does not
provide any specific evidence suggesting that, based on the general
knowledge in the art regarding backup systems, an ordinary artisan would
have been led to a device to have the particular processor configuration
required by Appellants' claim 38. Thus, although we agree that the
obviousness analysis necessarily involves consideration of the common
knowledge and ordinary creativity of a person skilled in the art, we are not
persuaded in this instance that the Examiner has advanced a sufficient
evidentiary basis for concluding that the specific processor configuration
recited in Appellants' claim 38 would have been obvious.
In sum, for the reasons discussed, the Examiner does not persuade us
that Banville and Neumiller would have suggested, to a person having
ordinary skill in this art, modifying Banville' s defibrillator to have the
specific processor configuration required by Appellants' claim 3 8, in which
the data processor provides redundancy control in the event of defibrillator
processor malfunction. We, therefore, reverse the Examiner's rejection of
claim 38, and its dependent claims 39, 51-53, 56, and 91 over Banville and
Neumiller.
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The Examiner rejected claims 40-50, 54, 55, and 57---68, which all
depend directly or ultimately from claim 38, over the base combination of
Banville and Neumiller discussed above, in further combination with a
number of additional references cited to show that claims 40-50, 54, 55, and
57-68 recite obvious variations of the invention recited in claim 38. Ans.
10-21. Because the Examiner does not explain, nor do we discern, how or
why the additionally cited references remedy the deficiencies discussed
above of Banville and Neumiller as to claim 38, we also reverse the
rejections appearing at pages 10-21 of the Examiner's Answer.
OBVIOUSNESS-
BANVILLE, NEUMILLER, AND DICKS
The Examiner's Prima Facie Case
In rejecting independent claim 85 over Banville, Neumiller, and
Dicks, the Examiner relied on the combination of Banville and Neumiller as
evidence of the obviousness of claim 85' s defibrillator having an isolated
defibrillator processor and data processor, similar to the rationale described
above in relation to claim 38. Ans. 21-23.
The Examiner conceded that Banville' s defibrillator is not configured
so that the data processor module executes an event service for scheduled
downloading of data from the defibrillator to an external computing device
using the data processor module as a proxy, as claim 85 requires. Id. at 23.
The Examiner cited Dicks as evidence that claim 85' s download
element would have been an obvious feature of Banville' s defibrillator. Id.
at 23-24. Based on the references' combined teachings, the Examiner
reasoned:
It would have been obvious to one having ordinary skill in the
art for the modified Banville invention's data processor module
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to execute an event service for scheduled downloading of data
from the defibrillator to an external computing device using the
data processor module as a proxy, in order to enable the
defibrillator's collected sensor and therapy data to be backed up
to another device, using the data processor module to mediate
the transmission of the data to an external server, because Dicks
teaches that transmission of data through a proxy is a standard
method of transmitting data ,and because the regular backup of
data ensures that the data will not be lost in the event of a
failure of the components.
Id. at 24.
Analysis
Having carefully considered the arguments and evidence advanced by
Appellants and the Examiner, Appellants persuade us that the Examiner has
not shown by a preponderance of the evidence that the cited references
would have rendered obvious the device recited in claim 85. In particular,
we are not persuaded that the Examiner has explained adequately why, in the
absence of impermissible hindsight, the combination of Banville, Neumiller,
and Dicks would have suggested to an ordinary artisan an external
defibrillator having processing-isolated data and defibrillator processors, in
which the data processor is configured to execute an event service for
scheduled downloading of data from the defibrillator to an external
computing device using the data processor module as a proxy, as claim 85
reqmres.
Dicks describes methods in which data is transmitted from a medical
device, which may be a defibrillator, to an intermediate device which may
store the data. Dicks i-f 61; see also id. i-f 64 (Dicks' intermediate device may
receive data from a defibrillator, among other medical devices).
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The Examiner cites i-f 80 of Dicks as teaching the execution of an
event service providing for scheduled data downloading, as required by
Appellants' claim 85. Ans. 23-24 (citing i-f 80 of Dicks as disclosing that
"data may be transmitted in real-time or be stored for any desired length of
time, or produced when a particular event occurs, which is scheduled
downloading of data provided by an event service at a predetermined period
of time[]. This qualifies as an event service.").
We acknowledge the following disclosure in i-f 80 of Dicks:
The medical device data can ... be stored for any desired
length of time, and/or until a particular event occurs. For
example, the medical device data could be stored until it is
verified that the intermediary device and/or the medical data
server have received the data, allowing the data to be
retransmitted if necessary.
Dicks i-f 80. Thus, as Appellants point out, in contrast to claim 85's use of a
data processing module which is part of the actual defibrillator device, to
execute the scheduled download, Dicks' methods involve the use of an
intermediary device external to the defibrillator to execute the event service
providing for the data download from the defibrillator.
The Examiner responds that,
[r]egarding the use of a proxy service claimed in claim 85, it
would have been obvious to one having ordinary skill in the art
for a data processor to communicate with a proxy, rather than a
defibrillator processor, because the data processor is primarily
concerned with processing of data versus application of pulses
to the body.
Ans. 30.
Ultimately, we find that Appellants have the better position. It might
be true that it would have been obvious for the data processor of a
defibrillator to communicate with a proxy, as the Examiner posits. The
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Examiner, however, does not explain with any degree of specificity why
Dicks' disclosure of using an intermediary device external to the
defibrillator to execute an event service data download would have
suggested, instead, using the defibrillator's internal data processor to execute
the event service.
In sum, because the Examiner does not explain with sufficient
specificity why the combination of Banville, Neumiller, and Dicks suggests
a defibrillator having a data processor module configured as required by
claim 85, we reverse the Examiner's rejection of claim 85, and its
dependents, over those references.
SUMMARY
For the reasons discussed, we reverse each of the Examiner's
obviousness rejections.
REVERSED
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