Ex Parte Stickney et al

Patent Trial and Appeal Board

Sep 28, 2016

12688729 (P.T.A.B. Sep. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/688,729 01115/2010
96139 7590 09/30/2016
MARGER JOHNSON
-PHYSIO -CONTROL, INC.
888 SW 5th A venue, Suite 1050
PORTLAND, OR 97204
FIRST NAMED INVENTOR
Ronald E. Stickney
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.
7257-0199_pB10009.06 4208
EXAMINER
OROPEZA,FRANCESP
ART UNIT PAPER NUMBER
3766
NOTIFICATION DATE DELIVERY MODE
09/30/2016 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):
docketing@techlaw.com
physio_control_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONALD E. STICKNEY, JAMES W. TAYLOR,
PATRICIA O'HEARN, CYNTHIA P. JAYNE,
PAULA LANK, and DAVID R. HAMPTON
Appeal2015-000010
Application 12/688,729
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a pulse
detection method and an apparatus using patient impedance. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Physio-Control, Inc. (see
App. Br. 3).
Appeal2015-000010
Application 12/688,729
Statement of the Case
Background
Appellants' "invention relates generally to the detection of cardiac
activity in a patient, and more specifically, to a method and apparatus for
cardiac pulse detection" (Spec. i-f 2).
The Claims
Claims 33, 42, 47, 48, and 52 are on appeal. Independent claim 33 is
representative and reads as follows (emphasis added):
1. An electrotherapy device, comprising:
(g) electrodes adapted to sense an electrocardiogram (ECG)
signal from a patient and adapted to communicate an impedance-
sensing signal through the patient;
(h) an electrotherapy generator in communication with the
electrodes for delivering electrotherapy to the patient; and
(i) processing circuitry in communication with the electrodes
and the electrotherapy generator and configured to:
analyze the patient's ECG signal for asystole, and if
the patient is determined to be in asystole condition,
prompt a user for delivery of chest compressions; analyze
the impedance-sensing signal to determine the presence of
chest compressions being delivered to the patient and if
chest compressions are not determined to be present
during a cardiopulmonary resuscitation (CPR) period,
prompt delivery of chest compressions to the patient; and
analyze the impedance-sensing signal to determine
the presence of respiration in the patient by comparing
impedance signal data that is based on the impedance
sensing signal to a previously identified impedance signal
data pattern known to be indicative of a presence of
respiration, the processing circuitry further configured to
prompt the delivery of rescue breathing therapy to the
patient if respiration is determined not present in the
patient,
in which the electrotherapy generator and the processing
circuitry are implemented in an automated external defibrillator.
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App. Br. 25-26 (Claims Appendix).
The Issues
A. The Examiner rejected claims 33, 47, and 48 under 35 U.S.C. § 103(a)
as obvious over Welborn,2 Myklebust, 3 and Hoffman4 (Ans. 2-6).
B. The Examiner rejected claims 42 and 52 under 35 U.S.C. § 103(a) as
obvious over Welborn, Myklebust, Hoffman, and Herleikson5 (Ans. 6-7).
A. 3 5 U.S. C. § 103 (a) over Welborn, Myklebust, and Hoff man
The Examiner finds that Welborn teaches
an electrotherapy device comprising:
- electrodes (1, 2, 3, 41 - figure 1) adapted to sense an
electrocardiogram (ECG) /heart beat (electrical output of the
heart) from a patient and to communicate an impedance-sensing
signal (IPG - a mechanical output of the heart) [through] the
chest of the patient (column 3, lines 1-7, 28-32)[)],
- an electrotherapy generator(s) (7, 8-figure 3),
- processing circuitry (ECG detector (2), mechanical activity
detector/electrical impedance change detector (3), coincidence
detector ( 4), logical analyzer (5) - figure 3) locates the QRS
complex in the ECG signal, locates a segment of the impedance
signal commencing concurrent with a point in the QRS complex,
evaluates the segment for an energy feature, an amplitude
indicative of a pulse, and prompts delivery of therapy based on
absence of a cardiac pulse ( asystole ). (abstract; figures 1-3;
column 1, lines 28-39; column 2, lines 40-53; column 3, lines 1-
7, 15-32, 38-41, 55-60; column 4, lines 45-52, 58-68; column 5,
2 Welborn et al., US 3,716,059, issued Feb. 13, 1973.
3 Myklebust, EP 1,057,498 A2, published Dec. 6, 2000.
4 Hoffman et al., Respiratory monitoring with a new impedance
plethysmograph, 41 ANAESTHESIA 1139-1142 (1986).
5 Herleikson, US 6,625,487 B2, issued Sept. 23, 2003.
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Application 12/688,729
lines 17-27; column 5, line 61-column 6, line 7; column 8, lines
20-30, 39-47; column 20, lines 17-23).
(Ans. 2.) The Examiner concludes that it would have been obvious to
compare
impedance waveforms to a previously identified impedance
signal data pattern know to be indicative of a presence of
respiration and known to be indicative of a presence of chest
compressions in the modified Welborn system in order:
- to provide a monitoring system that does not require the
use of a pad to monitor chest compressions, but rather uses a
parameter already determined by the modified Welborn system,
the impedance-sensing signal, to determine the presence of
respiration and to determine the presence of chest compression,
so the patient's condition is properly interpreted and appropriate
treatment actions can be undertaken if respiration is not present
or if chest compressions are not being provided, and
- to monitor the effectiveness of the chest compressions
and respirations/rescue breathing so the care provided to the
• 1... • • ,..l ,..l -Co • • patient can ue optlm1zeu to ensure auequate prou1s10n is
occurring such that tissue damage especially in the heart and
brain is prevented (page 1139, summary; page 1139, column 2 -
the first and second full sentences; page 1140, second paragraph
under methods and the final sentence in the third paragraph under
methods; page 1140, first paragraph under results; page 1141,
first column - second full paragraph; page 1141, discussion
section which is continued on page 1142[)].
(Id. at 5---6.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Welborn, Myklebust, and
Hoffman render the claims prima facie obvious?
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Application 12/688,729
Findings of Fact
1. Welborn teaches:
A resuscitator apparatus includes means for detecting and
counting the electrical and mechanical output of the heart of a
suspected heart attack victim, and means for substantially
immediately applying a pacing pulse or a [ defibrillating] pulse,
as required. Thus, if both electrical and mechanical outputs have
low rates, or are nonexistent, a pacing pulse is automatically
applied for stimulating a heart beat in time with such pulse.
(Welborn Abstract; see also Ans. 2-3.)
2. Welborn teaches:
The control cabinet . . . suitably contains electronic
circuitry for sensing the electrocardiac signal generated by the
heart, electronic circuitry for sensing changes in the electrical
impedance of the patient's body, and electronic circuitry for
making logical decisions based upon the analysis of the
electrocardiac (ECG) and impedance (ICG) signals.
(Welborn 3:1-7; see also Ans. 2.)
3. Welborn teaches:
The voltage peaks of waveform D, which are
representative of electrical impedance changes in the patient's
chest, occur somewhat later than, but in a definite time
relationship with, the peaks of waveform B. The impedance
changes are brought about by mechanical movement of the
patient's heart, blood flow, or the like. . .. waveform artifacts
... may be present on the ICG waveforms due to patient
respiration or externally induced motion.
(Welborn 3:28-37; see also Ans. 3.)
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4. Welborn teaches "[t]he mechanical activity detector suitably
comprises an electrical impedance change detector" (Welborn 4:49-50; see
also Ans. 2).
5. Myklebust teaches "signal processing means for deduction of
respiratory signals and pulse signals or blood stream signals and signals to
indicate chest compression" (Myklebust Abstract; see also Ans. 3-5).
6. Myklebust teaches that "[i]f the electrodes are fixed to the
chest, breathing will also modulate the voltage measured. This is caused by
the impedance (thorax impedance) between the electrodes increasing upon
inhalation of air, by the current path lengthening as the lungs are filled with
air" (Myklebust i-f 7; see also Ans. 4), and that "[t]he above principles may
be used ... to demonstrate and document the use of heart compression
during the treatment" (Myklebust i-f 1 O; see also Ans. 4).
7. Myklebust teaches "[b]reathing or artificial ventilation will
cause small variations in this impedance. A normal inhalation will cause a
change in impedance in the order of 1 ohm. In addition, each heartbeat will
cause a change in impedance in the order of 10 milliohms" (Myklebust i-f 31;
see also Ans. 4).
8. Myklebust teaches "[t]he defibrillator display screen ... shows
the information from the impedance measuring system in the form of curves
for the blood stream signal and the respiratory signal respectively. In
addition, a text message is displayed to instruct the user regarding the action
to be taken according to the resuscitation flow diagram" (Myklebust i-f 38;
see also Ans. 3).
9. Hoffman teaches
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A new impedance plethy[ s ]mo graph respiratory monitor,
(AR-8800), was tested on anaesthetised dogs. Decreases in tidal
volume and total apnoea were brought about by partial and
complete airway obstruction and by partial and total muscle
paralysis. The changes in respiration were reliably detected by
the monitor and its alarms activated within 15-20 seconds. The
misinterpretation of gross body movement as normal breathing
did not occur.
(Hoffman Summary (emphasis removed); see also Ans. 5---6.)
10. Hoffman teaches that
[ m Jost modem apnoea monitors employ electrical impedance to
detect the respiratory waveform and to provide an alarm should
there be a cessation of breathing for a preset time period. A
major problem encountered in most current impedance monitors
is their inability to alarm for partial respiratory depression or for
either complete or partial upper airway obstruction accompanied
by ineffectual chest movement. These ineffectual chest
movements and attempts at gasping for air are frequently
interpreted by impedance monitors as normal respiratory wave
forms, thereby inhibiting the early activation of the alarm.
(Hoffman 1139: first col.-second col.; see also Ans. 5---6.)
11. Hoffman teaches:
The following AR-8800 alarms were activated and
observed: volume index (VI) alarm. This alarm was activated
by a fall in VI to below preset value (0-100% of baseline) or by
an increase in VI to above a preset value ( 100-150% of baseline);
the apnoea alarm was activated when there was absence of
breathing during a selected time period (7 .5-20 seconds). The
motion alarm motion light (no audible alarm) was activated by
gross body movement artefacts.
(Hoffman 1140: second col.; see also Ans. 5---6.)
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12. Hoffman teaches that "any changes in breathing and in chest
movement on respiration are reflected as changes above or below the 100%
baseline" (Hoffman 1142: first col.; see also Ans. 5---6).
Principles of Law
The Supreme Court explains that "the [obviousness] analysis need not
seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ." KSR Int 'l v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
Id. at 416. "If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-24; FF 1-12) and agree that the
claims would have been obvious over Welborn, Myklebust, and Hoffman.
We address Appellants' arguments below.
Appellants contend that
[ t ]he Welborn defibrillator may also falsely sense an autonomous
pulse when CPR is administered to a patient and is not designed
to make meaning of impedance signal data known to be
indicative of either chest compressions or patient breathing.
W elbom entirely disregards impedance signal data indicative of
chest compressions and/or patient breathing.
(App. Br. 21; see also App. Br. 14; Reply Br. 2.)
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We are not persuaded. W elbom teaches "means for detecting and
counting the electrical and mechanical output of the heart" and that "if both
electrical and mechanical outputs have low rates, or are nonexistent, a
pacing pulse is automatically applied for stimulating a heart beat in time
with such pulse" (FF 1; see also FF 4). Welborn also teaches "electronic
circuitry for sensing changes in the electrical impedance of the patient's
body, and electronic circuitry for making logical decisions based upon the
analysis of the electrocardiac (ECG) and impedance (ICG) signals" (FF 2),
and that "waveform artifacts ... may be present on the ICG waveforms due
to patient respiration or externally induced motion" (FF 3 (emphasis added).
Therefore, we agree with the Examiner that "W elbom is aware of at least
patient breathing data in the impedance signal, and does not disregard it but
rather designs the system to remove the breathing data by use of filtration of
the signal" (Ans. 17).
Appellants argue that "Myklebust does not teach any other
mechanism or method that compares an impedance signal data known to be
indicative of either chest compressions or patient breathing" (App. Br. 21-
22; see also App. Br. 15; Reply Br. 3).
We do not find this argument persuasive. Myklebust teaches "signal
processing means for deduction of respiratory signals and pulse signals or
blood stream signals and signals to indicate chest compression" (FF 5).
Myklebust also teaches that "[i]f the electrodes are fixed to the chest,
breathing will also modulate the voltage measured. This is caused by the
impedance (thorax impedance) between the electrodes increasing upon
inhalation of air, by the current path lengthening as the lungs are filled with
air" and that "[t]he above principles may be used ... to demonstrate and
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document the use of heart compression during the treatment" (FF 6
(emphasis added)). Myklebust further teaches that "[b ]reathing or artificial
ventilation will cause small variations in this impedance" (FF 7) and that
"[t]he defibrillator display screen ... shows the information from the
impedance measuring system in the form of curves for ... the respiratory
signal respectively. In addition, a text message is displayed to instruct the
user regarding the action to be taken according to the resuscitation flow
diagram" (FF 8). Therefore, Myklebust compares impedance signals in both
chest compression and patient breathing as both affect impedance signals
that are deduced or measured.
Appellants contend
The monitor described in the Hoffman article is not
designed to measure whether chest compressions are being
delivered to the patient. Rather, the monitor described in the
Hoffman article measures the compressions of the patient's chest
that occur without the assistance of a caregiver or treatment
equipment. The monitor described in Hoffman \'l/ould not
measure chest compressions being delivered to the patient
because that would be an inaccurate reading of the patient's
respiratory status and would frustrate the purpose of the intended
function of the device described in the Hoffman article, which is
to accurately identify when the patient begins to experience a
respiratory emergency.
(App. Br. 22; see also Reply Br. 3--4). We are not persuaded. As discussed
above, both chest compression and patient breathing affect impedance
signals that are deduced or measured. Further, Hoffman recognizes this as
Hoffman teaches that
A major problem encountered in most current impedance
monitors is their inability to alarm for partial respiratory
depression or for either complete or partial upper airway
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obstruction accompanied by ineffectual chest movement. These
ineffectual chest movements and attempts at gasping for air are
frequently interpreted by impedance monitors as normal
respiratory wave forms, thereby inhibiting the early activation of
the alarm.
(FF 10 (emphasis added); see also FF 9.) Hoffman also teaches that "any
changes in breathing and in chest movement on respiration are reflected as
changes above or below the 100% baseline" (FF 12 (emphasis added)). See
Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006)
("[O]bviousness must be determined in light of all the facts, and there is no
rule that a single reference that teaches away will mandate a finding of
nonobviousness. Likewise, a given course of action often has simultaneous
advantages and disadvantages, and this does not necessarily obviate
motivation to combine.") A combination of references may be obvious even
if the combination eliminates a benefit of one of the references. See In re
Urbanski, 809 F.3d 1237, 1242 (Fed. Cir. 2016).
Moreover, as the Examiner explains, "[t]he phrase 'compressions of
the patient's chest that occur without the assistance of a caregiver or
treatment equipment' is defined by the Appellant on page 16, beginning at
line 14 [of the Appeal Brief] as the mechanical act of breathing" and that
Hoffman teaches "changes in both breathing and chest movement are
monitored, [and] the change[s] in breathing and chest movement [are]
signaled with an alarm" (Ans. 21; FF 11-12).
Therefore, we are not persuaded by Appellants' contention that "[t]he
monitor described in the Hoffman article is not designed to measure whether
chest compressions are being delivered to the patient" because "that would
be an inaccurate reading of the patient's respiratory status and would
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frustrate the purpose of the intended function of the device described in the
Hoffman" (App. Br. 22).
Appellants argue that
A pattern indicates repetitive signal data readings that
occur over time. Instead, the device described in the Hoffman
article relies on a ratio of a current and a baseline reading to
measure the patient's ventilation. As described above, a baseline
reading is not equivalent to a pattern of events. Rather, the
baseline is a single, 15-second average reading that occurs when
the monitor described in the Hoffman article is attached to the
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patient, while the impedance signal data pattern recited in claim
33 is a series of events identified over time.
(Id.; see also Reply Br. 4---6.)
We do not find this argument persuasive. As the Examiner explains,
"[ w ]hile the baseline is taught by Hoffman to be an average of 15 seconds
worth of respiration waveforms (a repetitive reading that occurs over time)
and the baseline is a single waveform based on multiple waveforms signals,
the baseline signal does establish a single waveform with a recognizable
pattern" (Ans. 22). Further, as Appellants points out, "the device described
in the Hoffman article relies on a ratio of a current and a baseline reading to
measure the patient's ventilation" (App. Br. 22), but a ratio is also a pattern
that is based on at least two values for comparison.
Appellants argue that
Applicant's claims 33 and 47 recite that the processing
circuitry is configured to determine the presence of chest
compressions being delivered to the patient by comparing
impedance signal data to a previously identified impedance
signal data pattern known to be indicative of a presence of chest
compressions. Ventilation is not equivalent to chest
compressions being delivered to the patient.
(Id. at 22-23; see also App. Br. 16.) We are not persuaded for the reasons
discussed above. Accordingly, we agree with the Examiner that "[ w ]hile
physical compression of a person's chest is different from the person's
breathing process, the result from these actions is the same - air enters the
lungs of the patient" (Ans. 20). We further agree with the Examiner that
It would have been obvious to one having ordinary skill in
the art at the time of the invention to have used processing
circuitry that prompts the delivery of compressions, CPR and
rescue breathing, and an impedance signal analyzed to determine
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the presence or absence of the chest compressions, respiration
and rescue breathing in the Welborn system in order to have a
proven means to accurately interpret the patient's sudden death
cardiac condition so essential life-saving measures can start
immediately.
(Id. at 4.) In sum, Appellants fail to establish an evidentiary basis on this
record that overcomes the Examiner's finding that the combination is simply
"the predictable use of prior art elements according to their established
functions." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
(Id. at 421.) "[E]vidence of a motivation to combine need not be found in
the prior art references themselves, but rather may be found in 'the
knowledge of one of ordinary skill in the art or, in some cases, from the
nature of the problem to be solved.' . . . When not from the prior art
references, the 'evidence' of motive will likely consist of an explanation of
the well-known principle or problem-solving strategy to be applied. Dystar
Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F .3d
1356, 1366 (Fed. Cir. 2006) (emphases in original, quoting In re Dembiczak,
175 F.3d 994, 999 (Fed. Cir. 1999)). In other words, since respiration and
chest compression are both affected or utilized for CPR, we conclude that
one of ordinary skill in the art would have been motivated, and therefore, it
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would have been obvious, to measure signals that relate to the presence or
absence of both.
B. 35 U.S.C. § 103(a) over Welborn, Myklebust, Hoffman, and
Herleikson
The Examiner finds that because "Herleikson discloses an impedance
measurement system and teaches using an impedance measurement to
determine cardiac output for the purpose of determining cardiac
performance," and that "[i]t is well known in the cardiac performance
evaluation art that cardiac output is equal to the stroke volume times the
heart rate, hence cardiac output is necessarily determined in terms of stroke
volume and the rate of output, read as heart rate" (Ans. 7).
(Id.)
The Examiner concludes that it would have been obvious to
have used the impedance measurement to determine[]
cardiac output in the modified W elbom system in order for the
patient's condition to be correctly represented via the accurate
cardiac output measurement so appropriate treatment may be
quickly and effectively provided, and to provide an additional
feature indicative of the pulse to insure the pulse status is
properly determined (column 2, lines 33-37).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Welborn, Myklebust,
Hoffman, and Herleikson render the claims prima facie obvious?
Findings of Fact
13. Herleikson teaches "an electrotherapy device with an improved
apparatus and methodology for accurately measuring patient impedance.
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The present invention utilizes at least three electrodes placed at
predetermined relative locations on the patient's body, and measures the
voltage across different electrode pairs while an applying an alternating
current through certain electrodes" (Herleikson 2:6-17; see also Ans. 7).
14. Herleikson teaches that "the impedance values determined in
accordance with the present invention can also be utilized to increase the
accuracy of other determinations such as respiratory rate, cardiac output,
proper electrode placement, effects of CPR and the like" (Herleikson 2:33-
37; see also Ans. 7).
Analysis
We agree with the Examiner that the claims would have been obvious
over Welborn, Myklebust, Hoffman, and Herleikson. We address
Appellants' arguments below.
Appellants contend that
Herleikson does not cure the deficiencies of Welborn in
view of Myklebust and further in view of Hoffman. Rather,
Herleikson teaches a device that constructs a more accurate
model of a patient's body impedance by sensing impedance with
at least three electrodes and calculating impedance with a
sophisticated, multivariate equation that takes the electrodes into
account.
(App. Br. 23.)
We are not persuaded and agree with the Examiner that "[a]s noted in
the rejection of record[,] cardiac output is equal to the stroke volume times
the heart rate, hence cardiac output is necessarily determined in term or
stroke volume and the rate of output, read as heart rate" (Ans. 23). "Non-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
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references []. [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole." In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants argue that
Herleikson has no teaching related to measuring cardiac
output of the patient. Herleikson' s teaching of creating a better
model for sensing impedance is not equivalent to measuring a
patient's cardiac output because improved impedance signal
sensing is not a comparison of an impedance signal with a
previously identified impedance signal data pattern known to be
indicative of a presence of respiration.
(App. Br. 23-24.)
The Examiner has the better position. As the Examiner explains,
"Herleikson teaches obtaining an impedance measurement using a pair of
electrodes, read as two electrodes, and using the impedance values to
determine cardiac output" (Ans. 23-24; FF 13-14). See In re Merck & Co.,
800 F.2d at 1097.
SUMMARY
In summary, we affirm the rejection of claims 33 and 47 under 35
U.S.C. § 103(a) as obvious over Welborn, Myklebust, and Hoffman. Claim
48 falls with claim 4 7.
We affirm the rejection of claims 42 and 52 under 35 U.S.C. § 103(a)
as obvious over Welborn, Myklebust, Hoffman, and Herleikson.
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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