Ex Parte Schluess et al

Patent Trial and Appeal Board

Apr 12, 2016

12519782 (P.T.A.B. Apr. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/519,782 06/18/2009 Rainer Schluess
38107 7590 04/14/2016
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
P. 0. Box 3001
BRIARCLIFF MANOR, NY 10510
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.
2006P02147WOUS 5913
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
04/14/2016 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):
debbie.henn@philips.com
marianne.fox@philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAINER SCHLUESS and VITOR M. VICENTE ANTUNES
Appeal2014-000736
Application 12/519,782
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134(a) from the
Examiner's rejection of claims 1, 2, 6, 9-16, 20-22, 24, and 25. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
The Specification2 discloses a "technique for reducing the number of
false alarms in a patient monitoring system." Spec. 2: 1 7. The Specification
1 Appellants identify the Real Party in Interest as KONINKLIJKE PHILIPS
ELECTRONICS, N.V. App. Br. 1.
2 References the Specification herein refer to the substitute Specification
filed on June 18, 2009.
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Application 12/519,782
discloses a patient monitoring system comprising "a first sensor device
adapted to acquire a first patient signal corresponding to a first physiological
parameter ... [and] a second sensor device adapted to acquire a second
patient signal corresponding to a second physiological parameter." Spec.
2: 18-22. The second patient signal comprises "an overlay signal caused by
the first physiological parameter." Spec. 2 :22-23. An overlay signal is "an
information signal that is contained within a primary (raw) signal and can be
extracted out of the primary signal." Spec. 4:8-11. "For example, ECG is
usually measured for the heart activity ... pleth is primarily measured to
derive the pulse rate and the Sp02 value, [and] invasive blood pressure is
measured to derive the blood pressure ... [but] these signals also contain
some information about respiration activity." Spec. 4:15-19. The system
includes a processing device configured "to determine from the first patient
signal a first value of the first physiological parameter ... [and to] determine
from the overlay signal of the second patient signal a second value of the
first physiological parameter ... and to analyze the first and second
value[s]." Spec. 2:23-27. The system includes "a control device adapted to
control a patient monitor alarm system depending on the result of the
analysis." Spec. 2:27-29.
Claim 1 is representative of the claims on appeal and reads as follows:
1. A patient monitoring system, comprising:
a first sensor device configured to acquire a first patient signal which
conveys a first physiological parameter of the patient;
a second sensor device configured to acquire a second patient signal
which conveys a second physiological parameter of the patient, said second
patient signal being overlayed with an overlay signal caused by the first
physiological parameter of the patient;
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a processing device configured to determine from the first patient
signal a first value of the first physiological parameter of the patient, to
determine from the overlay signal overlayed on the second patient signal a
second value of the first physiological parameter of the patient, and to
analyze the first and second value of the first physiological parameter of the
patient to verify the first patient signal acquired from the first sensor device
is accurate; and
a control device adapted to control a patient monitor alarm system
depending on the result of the analysis.
The following grounds of rejection are before us:
I. Claims 1, 2, 9-12, 16, 20-22, 24, and 25 stand rejected under
35 U.S.C. § 103(a) in view of Tarassenko3 and Galvin. 4
II. Claims 6, 13, and 15 stand rejected under 35 U.S.C. § 103(a) in view
of Tarassenko and Snyder. 5
III. Claim 14 stands rejected under 35 U.S.C. § 103(a) in view of
Tarassenko, Snyder, and Galvin.
I.
Issue
The Examiner has rejected claims 1, 2, 9-12, 16, 20-22, 24, and 25
under 35 U.S.C. § 103(a) as obvious in view of Tarassenko and Galvin.
Final Rejection6 4--9 and 13-17; Ans. 2-3.
The issue presented is: Does the evidence of record support the
Examiner's conclusion that Tarassenko and Galvin would have made
3 Tarassenko et al., US 2005/0027205 Al, published Feb. 3, 2005.
4 Galvin, US 4, 195,286, issued Mar. 25, 1980.
5 Snyder et al., US 4,686,999, issued Aug. 18, 1987.
6 Office Action mailed December 13, 2012.
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obvious a patient monitoring system comprising a first sensor device
configured to acquire a first patient signal, a second sensor device
configured to acquire a second patient signal which is overlayed with an
overlay signal, and
a processing device configured to determine from the first
patient signal a first value of the first physiological parameter of
the patient, to determine from the overlay signal ... a second
value of the first physiological parameter of the patient, and to
analyze the first and second value of the first physiological
parameter ... to verify the first patient signal acquired from the
first sensor device is accurate; and
a control device adapted to control a patient monitor alarm
system depending on the result of the analysis
as required by claim 1.
Analysis
We have reviewed Appellants' contentions that the Examiner erred in
rejecting claims 1, 2, 9-12, 16, 20-22, 24, and 25 as obvious over the cited
art. App. Br. 9-16, Reply Br. 2---6. We disagree with Appellants'
contentions and adopt the findings concerning the scope and content of the
prior art set forth in the Examiner's Answer and Final Rejection dated
December 13, 2012. For emphasis, we highlight and address the following:
1. Tarassenko discloses that " [ e] lectrical impedance
plethysmography ... can be used to provide an indirect measure of
respiration by measuring the changes in electrical impedance across the
chest with breathing." Tarassenko, i-f 2. "The electrical impedance increases
as high-resistivity air enters the lungs during inspiration but part of the
change is also due to the movement of the electrodes on the chest wall."
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Tarassenko, i-f 2. "[I]n a clinical environment, the impedance
plethysmography (IP) signal is often very noisy and is seriously disrupted by
patient movement or change in posture ... it has not been considered
reliable enough to provide respiration information for regular use on the
ward." Tarassenko, i-f 2.
2. Tarassenko discloses that "[r]espiratory information is found in
other signals recorded from patients with non-invasive sensors. For
example, both the electrocardiogram (EGG) and photoplethysmogram (PPG)
waveforms are modulated by the patient's breathing." Tarassenko, i-f 3.
"The PPG signal represents the variation in light absorption across a finger
or earlobe with every heart beat. This signal is measured ... in a standard
pulse oximeter." Tarassenko, i-f 3.
3. Tarassenko discloses a method of measuring a subject's
breathing rate that comprises the steps of "predicting the value of each of
two independent measurements of the breathing rate, making two
independent measurements of the breathing rate to produce two measured
values, calculating the respective differences between the predicted values
and the measured values, and combining the two measured values with
weights determined by said differences." Tarassenko, i-f 10. Accordingly,
"two measurements of breathing rate made in different ways are combined
with weights based on the amount of 'confidence' in the measurement, to
give an improved measurement or estimate of the actual breathing rate." Id.
at ,-r 9.
4. Tarassenko discloses a breathing rate measurement apparatus
wherein a "PPG signal is obtained ... using a conventional PPG sensor 1
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which ... supplies its output to PPG apparatus 3." Tarassenko, i-f 27. "An
IP signal is obtained by conventional IP equipment 7 using two electrodes S
... The IP apparatus 7 and PPG apparatus 3 supply their signals to a
processor 10 which processes the signals ... and outputs a display of
breathing rate on display 12." Tarassenko, i-f 27. "The processor 10 . .. runs
a Kalman filter on each breathing rate signal, and then fuses the filtered
signals to produce a fused estimate of the breathing rate." Tarassenko, i-f 28.
5. Tarassenko discloses that the
advantages of this method can be appreciated from four
possible contexts:
1. normal breathing: low innovations on both channels;
both measurements BRl and BR2 are weighted equally.
2. valid change seen on both channels: the subject begins
to breathe more quickly or more slowly due to a physiological
change; although the innovation is high, it is high for both
channels, and so both (valid) measurements are again weighted
equally.
3. artefact on one channel: high innovation on one channel
only; the information from that channel is ignored because it is
given a low weighting (high variance).
4. artefact on both channels: the information is corrupted
on both channels. Prolonged movement artefact, however, is
characterised by high values of innovation on both channels for
a sustained period of time and this can be the basis for discarding
sections of data corrupted by movement artefact.
Tarassenko, ,-r 35-39.
6. Galvin discloses an alarm system with "two output modes,
[with] one providing relatively high detection probability and the other
providing relatively low false alarm probability." (Galvin, Abstract). "Two
or more sensors are coupled to an associated logic circuit which provides a
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first alarm output in response to actuation of any one of the sensors, and a
second alarm output in response to actuation of the two or more sensors
within a predetermined time interval." (Galvin, Abstract).
7. Galvin discloses that the sensors can be any "known type
providing an output signal in response to an intended sensed condition.
These sensors can be, for example, intrusion sensors for detection of an
intruder in a protected area, or fire sensors of heat and/ or smoke types for
detection of fire in a protected area." Galvin, col. 2, 11. 9-14. Galvin
discloses that the "sensors employed according to the invention provide
overlapping coverage of an area or zone so that sensor redundancy can
provide reduced false alarm rates in one of the two operative modes."
Galvin, col. 2, 11. 14--18.
8. Galvin discloses that, "[i]f only one sensor 10 or 12 is actuated,
the sensor output signal is coupled ... to the local alarm 24 for actuation of
that alarm." Galvin, col. 2, 11. 32-34. "The remote alarm 28 is not energized
in response to single sensor actuation." Galvin, col. 2, 11. 34--36. "The local
alarm 24, being actuated by the triggering of any one or more of the sensors,
provides relatively high detection reliability." Galvin, col. 2, 11. 38--40.
"The remote alarm 28 is actuated only upon the nearly simultaneous
triggering of the multiple sensors to achieve a relatively low false alarm
rate." Galvin, col. 2, 11. 44--46. "Such remote alarm typically is an alarm
indicator at a central station, or [a] police or fire station where lower false
alarm rates are important to the orderly management of such a facility."
Galvin, col. 2, 11. 46-50.
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The Examiner finds that Tarassenko discloses a patient monitoring
apparatus comprising a first sensor device and second sensor device,
wherein the "first sensor device (IP apparatus 7) ... acquire[s] a first patient
signal which conveys a first physiological parameter of the patient." Ans. 4,
citing Tarassenko, ,-r 2. The Examiner finds that the "second sensor device
(PPG apparatus 3) ... acquire[s] a second patient signal which conveys a
second physiological parameter of the patient (pulsation detected via PPG)."
Ans. 4. The Examiner finds that the "second patient signal ... [is]
overlayed with an overlay signal caused by the first physiological parameter
of the patient( ... PPG waveform is modulated by patient breathing)." Ans.
4, Tarassenko, ,-r 3. The Examiner finds that Tarassenko discloses a
processing device that is configured to determine a first value of the first
physiological parameter from the first patient signal and a second value from
the overlay signal of the second patient signal and configured to process "the
signals to output a breathing rate ... [that] is measured from each raw signal
supplied by the IP and PPG sensors." Ans. 4--5, citing Tarassenko, ,-r 27.
The Examiner finds that Tarassenko discloses that the processor analyzes
"the first and second value[ s] of the first physiological parameter of the
patient." Ans. 5, citing Tarassenko, ,-r 10.
The Examiner finds that Tarassenko does not disclose that the first
and second values of "the first physiological parameter of the patient verify
the first patient signal acquired from the first sensor device, or a control
device adapted to control a patient monitor alarm system," but that Galvin
discloses an alarm that responds to an input signal from a first sensor device
wherein a "remote alarm 28 is not energized in response to single sensor
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actuation ... in the absence of a second input signal from the other sensor."
Ans. 5, citing Galvin, Abstract and col. 2, 11. 33-51. The Examiner finds
that Galvin's system "is understood to 'verify' the first sensor device (e.g.,
sensor 1) is accurate in a manner similar to Applicants' disclosure ... by
using both signal[ s] (e.g., from sensors 1 and 2) to decid[ e] whether or not to
issue an alarm." Ans. 5. The Examiner concludes that, in view of Galvin, it
would have been obvious to one of ordinary skill in the art to modify
Tarassenko's system with a processing device that verifies "the accuracy of
the first signal acquired from the first sensor device and ... control[ s] an
alarm system ... in order to provide the predictable results of lowering false
alarm rates ... [in] a hospital, [or] clinic, etc." Ans. 5-6, citing Galvin, col.
2, 11. 33-51.
Appellants argue that neither Tarassenko nor Galvin "suggest a
processing device adapted to ... analyze the first and second value[s] of the
first physiological parameter of the patient to verify the first patient signal
acquired from the first sensor device is accurate." App. Br. 10. Appellants
argue that Galvin's sensors "do not measure values ... [but, instead,]
provide a signal in response to sensing by a predetermined condition,"
wherein alarms are triggered in response to actuation of sensors, rather than
"checking the accuracy of measured values received from a sensor by
analyzing values received from a second sensor." App. Br. 10. Appellants
argue that Galvin discloses the triggering of an alarm by evaluating a signal
"generated by one or more sensors detecting ... [a] condition such as an
intrusion, a fire, or smoke ... [whereas the instant] application analyzes first
and second values of a physiological parameter of a patient to verify ...
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[that] a first sensor device is accurate." App. Br. 10. Appellants argue that
"neither Tarassenko, nor Galvin ... suggest a processing device adapted to
... analyze the first and second value of the first physiological parameter of
the patient to verify the first patient signal acquired from the first sensor
device is accurate." App. Br. 10.
Appellants' arguments are not persuasive. "The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007).
If a person of ordinary skill can implement a predictable
variation, § 103(a) likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.
Id. at 417. In determining \vhether 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
Keller, 642 F.2d 413, 425 (CCPA 1981).
Here, Tarassenko discloses a patient monitoring system and method
that measures a subject's breathing rate by making two independent
measurements of the breathing rate, e.g. by both electrical impedance
plethysmography and detecting photoplethysmogram waveforms, to produce
two measured values, and then assigning weights to the values according to
how much the values deviate from predicted values, and then determining a
respiration rate from the weighted values. FFs 3 and 4. Tarassenko
discloses that the advantages of this method can be appreciated from several
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possible contexts, including wherein breathing rate "information from [the
second of two channels] is ignored because it is given a low weighting (high
variance)." FF 5.
Thus, Tarassenko discloses that a second measured value for
respiration can be used to determine whether a first measured value for
respiration should be relied upon or discounted. Tarassenko does not
disclose the activation of an alarm system in response to respiration rate
determination, but implicitly teaches the desirability of reliably measuring
respiration in a clinical setting, and it would have been obvious to one of
skill in the art to provide Tarrasenko's system with an alarm that would
activate when either one or both of the measured values for respiration
indicated a problem with respiration. Galvin discloses that alarm systems
can be designed to depend on one or more sensors to trigger alarm systems
(FFs 6-8). Therefore, we agree with the Examiner the combination of
Tarassenko and Galvin would have made obvious a patient monitoring
system comprising "a processing device adapted to ... analyze the first and
second value[ s] of the first physiological parameter of the patient to verify
the first patient signal acquired from the first sensor device is accurate," as
required by claim 1.
Thus, we affirm the rejection of claim 1 as being obvious in view of
Tarassenko and Galvin. Claims 2, 9, 21, 24, and 25 have not been argued
separately and fall with claim 1. See 37 C.F.R. § 41.37(c)(l)(iv).
Appellants also argue the rejection of claim 10. Claim 10 depends
from claim 1 and further requires that "the processing device determines if at
least one of the first and second values exceed a predetermined threshold."
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Appellants argue that "Tarassenko does not teach or suggest determining of
[sic] the first and second values exceed a predetermined threshold." App.
Br. 12. Appellants argue that "Tarasseko [sic] teaches away from such a
modification as the first and second values are combined to generate a
combined breathing rate." App. Br. 12. Appellants argue that there is no
reason why one of skill in the art "would include determining if the ...
values exceed a predetermined threshold to generate the combined breathing
rate ... [and] the rejection lacks a clear articulation of the reasons why these
features would allegedly have been obvious." App. Br. 12.
The Examiner responds that it would have been obvious to one of
ordinary skill in the art to modify Tarassenko' s system "with the processing
device determining if at least one of the first and second values (e.g.,
measured respiration rate values) exceed[ s] a predetermined threshold
because it is well known in the art to compare measured vital sign values
with predetermined thresholds" to determine or indicate whether the vital
sign values are outside the normal range, thereby "allowing for timely
medical assistance or intervention." Ans. 3 and 7. The Examiner further
responds that, "Galvin discloses determining if measured values exceed a
predetermined threshold ... where[in] sensors provide an output signal in
response to an intended sensed condition." Ans. 3, citing Galvin, col. 2, 11.
9-19.
We agree with the Examiner's reasoning and conclusion. Although
Tarassenko is directed to a system and method to accurately determine the
respiration rate, Tarassenko discloses that the system determines whether the
values measured by the two measuring systems deviate from predicted
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respiration rates. It would have been obvious to one of skill in the art to
modify Tarassenko' s system to include alarm system activation, such as
expressly provided by Galvin, if both respiration measurements significantly
differed from predicted values, i.e. exceeded a threshold, because such an
alarm system would alert clinic staff to the necessity of a clinical
intervention. Thus, we affirm the rejection of claim 10 as being obvious in
view of Tarassenko and Galvin.
Appellants also argue the rejection of claim 11. Claim 11 depends
from claim 10 and further requires that the "control device triggers the
monitoring alarm in response to the first and second values being outside the
predetermined threshold and suppresses the monitoring alarm in response to
the first value being outside the predetermined threshold and the second
value being within the threshold." Appellants argue that neither Tarassenko
nor Galvin teach or suggest this limitation. App. Br. 13. Appellants argue
that Galvin teaches "triggering alarms in response to ... a sensor detecting
... [a] condition such as an intrusion, a fire, or smoke. The sensors of
Galvin do not measure values." App. Br. 13. Appellants argue that Galvin
does not "detect when values are outside predetermined limits" nor teach
"triggering an alarm in response to the output signal being outside a
predetermined threshold." App. Br. 14. Appellants argue that neither
Tarassenko nor Galvin teach or suggest the limitation of claim 11. App. Br.
4--5.
Appellants' arguments are not persuasive. As discussed, we have
concluded that it would have been obvious to one of skill in the art to modify
Tarassenko's system to include alarm system activation, such as taught by
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Galvin, if both respiration measurements significantly differed from
predicted values, i.e. exceeded a threshold, because such an alarm system
would alert clinic staff to the necessity of a clinical intervention.
Additionally, Tarassenko discloses the desirability of two methods for
measuring respiration because one method of respiration measurement such
as impedance plethysmography can be disrupted by patient movement thus
present issues of reliability. See FF 1. Thus, it would have been obvious to
one of skill in the art to design a patient monitoring system with two
methods to monitor respiration, wherein an alarm is triggered if measured
values for respiration from both measuring systems exceed a threshold but to
suppress alarm activation if one of the systems for measuring respiration did
not indicate that the threshold had been exceeded. Thus, we affirm the
rejection of claim 11 as being obvious in view of Tarassenko and Galvin.
Claim 12: Appellants also argue the rejection of claim 12. Claim 12
depends from claim 1 and further requires that
the second patient signal includes direct data corresponding to
the second physiological parameter of the patient and indirect
data corresponding to the first physiological parameter of the
patient and the processing device determines whether the first
value of the first patient signal is in an alarm range, whether the
indirect data is consistent with the first patient signal, and in
response to the indirect data being inconsistent with the first
patient signal, suppresses an alarm.
Appellants argue that neither Tarassenko nor Galvin teach or suggest
that "the processing device determines whether the first value of the first
patient signal is in an alarm range, whether the indirect data [from the
second patient sensor] is consistent with the first patient signal" and
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suppressing the alarm if there is no consistency. App. Br. 14. Appellants
argue that the Examiner relies on Galvin for teaching the limitations of claim
12, but that "Galvin does not teach determining whether the first value of the
first patient signal is in an alarm range." App. Br. 14. Appellants argue that
"Galvin teaches triggering alarms in response to receiving an output signal
from a sensor detecting an intended sensed condition such as an intrusion, a
fire, or smoke. The sensors of Galvin do not measure values." App. Br. 14.
Appellants' arguments are not persuasive. As discussed above,
Tarassenko discloses that two methods for measuring respiration are needed,
because one method of respiration measurement such as impedance
plethysmography can be disrupted by patient movement and thus present
issues of reliability. Each method provides a patient signal corresponding to
a physiological patient parameter. Thus, it would have been obvious to one
of skill in the art to design a patient monitoring system with two methods of
respiration, providing first and second patient signals, wherein an alarm is
triggered if measured values for respiration from both measuring systems
exceed a threshold but to suppress alarm activation if one of the systems for
measuring respiration did not indicate that the threshold had been exceeded,
i.e., where the two signals are inconsistent. Thus, we affirm the rejection of
claim 12 as being obvious in view of Tarassenko and Galvin.
Appellants also argue the rejection of independent claim 16. Claim 16
is directed to a method of monitoring a patient that comprises, among other
things, the steps of
analyzing the first and second values of the first
physiological parameter of the patient to determine if at least one
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of the first and second values exceed a predetermined threshold
triggering an alarm in response to the first and second
values being outside the predetermined threshold with a control
device; and
suppressing the alarm in response to the first value of the
first physiological parameter of the patient determined from the
first patient signal being outside the predetermined threshold and
all of the plurality of second values of the first physiological
parameter determined from the second physiological parameter
signal being within the threshold with the control device. 7
Appellants argue that neither Tarassenko nor Galvin disclose
analyzing "first and second values to determine if the values exceed a
predetermined threshold." App. Br. 16.
Appellants' arguments are not persuasive. As discussed above with
regard to claim 10, it would have been obvious to one of skill in the art to
modify Tarassenko' s system to include alarm system activation such as
taught by Galvin if both respiration measurements significantly differed
from predicted values, i.e. exceeded a threshold, because such an alarm
system would alert clinic staff to the necessity of a clinical intervention.
Thus, we affirm the rejection of claim 16 as being obvious in view of
Tarassenko and Galvin.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
Tarassenko and Galvin would have made obvious a patient monitoring
7 The full text of independent claim 16 can be found in the Claims Appendix
to the Appeal Brief (App. Br. 21-22).
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system comprising a first sensor device configured to acquire a first patient
signal, a second sensor device configured to acquire a second patient signal
which is overlayed with an overlay signal, and
a processing device configured to determine from the first
patient signal a first value of the first physiological parameter of
the patient, to determine from the overlay signal ... a second
value of the first physiological parameter of the patient, and to
analyze the first and second value of the first physiological
parameter ... to verify the first patient signal acquired from the
first sensor device is accurate; and
a control device adapted to control a patient monitor alarm
system depending on the result of the analysis
as required by claim 1.
II.
Issue
The Examiner has rejected claims 6, 13, and 15 under 35 U.S.C.
§ 103(a) as obvious in view ofTarassenko and Snyder (Fin. Rej. 9-12).
6. A method of monitoring a patient, the method comprising:
acquiring a first patient signal corresponding to a first physiological
parameter of the patient with a first sensor device;
determining from the first patient signal a first value of the first
physiological parameter of the patient with a processing unit;
acquiring a second patient signal corresponding to a second
physiological parameter of the patient with a second sensor device, the
second physiological parameter being different from the first physiological
parameter and the second patient signal including an overlay signal
corresponding to the first physiological parameter of the patient;
determining from the overlay signal of the second patient signal a
second value of the first physiological parameter of the patient with a
processing unit, analyzing the first and second values of the first
physiological parameter of the patient to determine if at least one of the first
and second values exceeds a predetermined threshold with the processing
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unit; and releasing a monitoring alarm in response to the at least one of the
first and second values exceeding a predetermined threshold.
The issue presented is: Does the evidence of record support the
Examiner's conclusion that Tarassenko and Snyder would have made
obvious a method of patient monitoring that comprises, among other steps,
the step of
analyzing the first and second values of the first physiological
parameter of the patient to determine if at least one of the first
and second values exceeds a predetermined threshold with the
processing unit; and releasing a monitoring alarm in response to
the at least one of the first and second values exceeding a
predetermined threshold
as required by claim 6?
Analysis
We have reviewed Appellants' contentions that the Examiner erred in
rejecting claims 6, 13 and 15 as obvious over the cited art. App. Br. 9-18,
Reply Br. 2-9. We disagree with Appellants' contentions and adopt the
findings concerning the scope and content of the prior art set forth in the
Examiner's Answer and Final Rejection dated December 13, 2012. For
emphasis, we highlight and address the following:
9. Snyder discloses a ventilation monitor that "includes a plurality
of discrete sensors and a plurality of independent channels for processing the
input signals from each of the discrete sensors. The principle [sic] category
of sensor ... is capable of the reception of information associated with
breathing and cardiovascular movement." Snyder, Abstract. A second
category of the sensor is capable of the reception of audible sounds
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associated with breathing. Snyder discloses the activation of an alarm when
the monitored breathing pattern is abnormal. Snyder, Abstract.
10. Snyder discloses that, "[t]ypically, the system will be set by the
clinician to monitor a physiological activity with upper and lower limits on
the average rate. For example, the respiratory rate range for newborns might
be defined as 30-60 breaths per minute, and the heart rate defined as a rate
range of 100-140 beats per minute." Snyder, col. 7, 11. 1---6.
11. Fig. 6 of Snyder is shown below:
.:ii.~'!W.:\~'.f
~~,\~l'>f
Figure 6 shows an "illustration of the signal processing logic for the alarm
date [sic, data] circuit." Snyder, col. 5, 11. 3--4.
12. Snyder discloses that Figure 6 shows that "the alarm update
simply checks the mattress and audio respiratory status alarm. If the
respiratory signal is perceived to be abnormal, an alarm is activated by the
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Application 12/519,782
alarm update system logic." Snyder, col. 10, 11. 56-61. "[T]he alarm update
system logic checks the cardiac status alarm. If any unusual status has been
set, then an alarm is activated." Snyder, col. 10, 11. 61---64.
The Examiner relies on Tarassenko as discussed above. Ans. 11. The
Examiner finds that Snyder discloses determining respiration status using
both a mattress motion sensor and an acoustic respiration sensor "to
determine if at least one of the first and second values exceeds a
predetermined threshold ... and releasing a monitoring alarm in response to
at least one of the first and second values exceeding a predetermined
threshold." Fin. Rej. 11, citing Fig. 6. The Examiner concludes that it
would have been obvious to one of ordinary skill in the art, in view of
Snyder, to modify Tarassenko's method with "analyzing the first and second
values of the first physiological parameter and releasing a monitoring alarm
in response to at least one of the first and second values exceeding a
predetermined threshold ... [to] monitor[] ... changing levels of respiratory
activity." Fin. Rej. 11, citing Snyder, col. 2, 11. 23---64.
Appellants argue that neither Tarassenko nor Snyder teach or suggest
"analyzing the first and second value[ s] of the first physiological parameter
... to determine if at least one of the first and second values exceed a
predetermined threshold with the processing device and controlling the
release of a monitoring alarm depending on the result of the analysis with a
control device." App. Br. 12. Appellants argue that, in Snyder's monitor, a
"first sensor ... receives information associated with breathing and
cardiovascular movement. A second sensor ... receives audible sounds
associated with breathing. The signals ... are then compared to verify a
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Application 12/519,782
normal breathing pattern and signal an alarm when the breathing pattern is
abnormal." App. Br. 11. Appellants argue that "Snyder does not teach
comparing the first and second values with a single predetermined
threshold," because, in Snyder, "the audio respiration value is compared
with an audio respiration accepted threshold and the cardiac status value is
compared with a cardiac status accepted threshold." App. Br. 11, citing Fig.
6.
Appellants' arguments are not persuasive. As discussed above,
Tarassenko discloses that a second measured value for respiration can be
used to determine whether a first measured value for respiration should be
relied upon or discounted. Thus, in Tarrasenko, the two measured values are
compared to the same threshold. Tarassenko does not disclose the activation
of an alarm system in response to respiration rate determination, but
Tarassenko discloses the necessity of reliably measuring respiration in a
clinical setting. Snyder discloses a patient monitoring system that activates
an alarm when the breathing pattern is abnormal. FFs 9, 11, and 12. It
would have been obvious to one of ordinary skill in the art to provide
Tarassenko's system with an alarm that would activate when either one or
both of the measured values for respiration indicated a problem with
respiration. Thus, we affirm the rejection of claim 6 as being obvious in
view of Tarassenko and Snyder.
Appellants also argue the rejection of claim 15. Claim 15 depends
from claim 6 and further requires that "the second patient signal includes
direct data corresponding to the second physiological parameter of the
patient and indirect data corresponding to the first physiological parameter
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of the patient" and that "the analyzing step includes whether the first and
second values of the first physiological parameter are consistent."
Appellants argue that the Examiner acknowledges that Tarassenko does not
teach the limitation of claim 15, and Appellants further argue that Galvin
does not cure this deficiency in Tarassenko. App. Br. 15.
Appellants' arguments are not persuasive. As discussed above,
Tarassenko discloses that two methods for measuring respiration are needed,
because one method of respiration measurement such as impedance
plethysmography can be disrupted by patient movement and thus present
issues of reliability. Thus, it would have been obvious to one of skill in the
art to design a patient monitoring system with two methods of respiration
measurement and that can determine whether two different values for
respiration measurement are consistent. Thus, we affirm the rejection of
claim 15 as being obvious in view of Tarassenko and Snyder.
III.
The Examiner has rejected claim 14 under 35 U.S.C. § 103(a) as
obvious in view of Tarassenko and Snyder, and further in view of Galvin.
Fin. Rej. 12-13.
Claim 14 depends from claim 6, and further requires "triggering the
monitoring alarm in response to the first and second values exceeding the
predetermined threshold; and suppressing the alarm in response to the first
value being outside the predetermined threshold and the second value being
within the threshold."
The Examiner relies on Tarassenko and Snyder as discussed above,
but finds that neither reference explicitly teaches the limitation of claim 14.
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Fin. Rej. 12. The Examiner finds that Galvin discloses "triggering the
monitoring alarm in response to first and second values being outside the
predetermined threshold." Fin. Rej. 12, citing Galvin, col. 1, 11. 31-53. The
Examiner finds that Galvin's "second alarm is triggered by actuation of the
two or more sensors ... [and] 'actuation' of the sensors only occurs when
values are detected outside preset limits." Fin. Rej. 12-13. The Examiner
finds that Galvin discloses "suppressing the alarm in response to the first
value being outside the predetermined threshold and the second value being
within the threshold ... [wherein] remote alarm 28 is not energized in
response to single sensor actuation" Fin. Rej. 13, citing Galvin, col. 2, 11.
33-51. The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to modify Tarassenko' s method "with triggering the
monitoring alarm in response to the first and second values being outside the
predetermined threshold and suppressing the alarm in response to the first
value being outside the predetermined threshold and the second value being
within the threshold as taught by Galvin in order the provide the predictable
results of lowering false alarm rates to assist in orderly management of large
facilities monitoring multiple alarm systems ... such as a hospital, clinic,
etc." Fin. Rej. 13.
Appellants argue that the Examiner "asserts that Galvin teach[ es] an
alarm system having improved false alarm rate and detection reliability
comprising a control device that triggers a monitoring alarm in response to
the first and second values being outside the predetermined threshold." App.
Br. 14--15. Appellants argue that "Galvin does not detect when values are
outside predetermined limits . . . [but] teaches triggering alarms in response
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to receiving an output signal from a sensor detecting an intended sensed
condition such as an intrusion, a fire, or smoke." App. Br. 15. Appellants
argue that Galvin's sensors "do not measure values ... [and] Galvin doesn't
teach triggering an alarm in response to the output signal being outside a
predetermined threshold." App. Br. 15. Appellants argue that the
combination of the cited references does not teach or suggest the limitation
of claim 14. App. Br. 15.
Appellants' arguments are not persuasive. As discussed above, we
have concluded that the combination of Tarassenko and Galvin would have
made obvious to one of ordinary skill in the art a patient monitoring system
with two methods to monitor respiration, wherein an alarm is triggered if
measured values for respiration from both measuring systems exceed a
threshold but to suppress alarm activation if one of the systems for
measuring respiration did not indicate that the threshold had been exceeded.
Thus, we affirm the rejection of claim 14 as being obvious in view of
Tarassenko, Snyder, and Galvin.
SUMMARY
We affirm the Examiner's rejections of claims 1, 2, 6, 9-16, 20-22,
24, and 25 under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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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