Ex Parte Ukawa

Patent Trial and Appeal Board

Apr 12, 2016

12638658 (P.T.A.B. Apr. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/638,658 12/15/2009 TeijiUKAWA
39083 7590 04/14/2016
KENEALY VAIDYA LLP
3000 K Street, N.W.
Suite 310
Washington, DC 20007
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.
6002-0041 5439
EXAMINER
BURRAGE, MICHAEL J
ART UNIT PAPER NUMBER
WMB
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):
avaidya@kviplaw.com
uspto@kviplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TEIJI UKA WA
Appeal2014-000611
Application 12/638,658
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 1-15. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
The Specification discloses "a respiratory function measuring
apparatus which can measure a respiratory function signal indicative of an
intrathoracic pressure change and the like from the invasive blood pressure"
1 Appellant identifies the Real Party in Interest as Nihon Kohden
Corporation (App. Br. 3).
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Application 12/638,658
(Spec. 1 i-f 1).2 "In the measurement of work of breathing, the measurement
of the intrathoracic pressure is necessary, but it is difficult to measure the
intrathoracic pressure .... In the vicinity of the right atrium, particularly, the
central venous pressure is low, and hence strongly reflects the intrathoracic
pressure" (id. at 1 i-fi-12 and 3). The Specification discloses "a respiratory
function measuring apparatus in which components derived from cardiac
contraction can be removed from a central venous pressure waveform ...
whereby the respiratory variation of the intrathoracic pressure can be easily
estimated" (id. at 2 i-f 6).
Claim 1, the only independent claim, is representative of the claims on
appeal and reads as follows:
1. A respiratory function measuring apparatus comprising:
a first sensor configured to detect an invasive blood
pressure;
a second sensor configured to measure frequency of at
least one of a heart beat and a respiration; and
a controller configured to obtain a respiratory function
signal from the invasive blood pressure detected by the first
sensor, by using at least one of the frequency measured by the
second sensor and a harmonic of the frequency.
2 References to the Specification herein refer to the substitute Specification
filed on July 12, 2012.
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Issue
The claims stand rejected under 35 U.S.C. § 103(a) as foIIows:
1. Claims 1-10 in view of Danehorn3 and Liao4 ;
IL Claim 11 in view ofDanehorn, Liao, and Joeken5;
!fl. Claims 12 and 15 in view of Danehom, Liao, and Euliano6; and
IV Claims 13 and 14 in view ofDanehom, Liao, and Anderson.7
I.
The Examiner has rejected claims 1-10 under 35 U.S.C. § 103(a) as
obvious over Danehom and Liao (Ans. 3---6).
The issue presented is: Does the evidence of record support the
Examiner's conclusion that the combination of Danehom and Liao would
have made obvious a respiratory function measuring apparatus having "a
controller configured to obtain a respiratory function signal from the
invasive blood pressure detected by the first sensor, by using at least one of
the frequency measured by the second sensor and a harmonic of the
frequency?"
3 Kenneth Danehom et al., US 2007/0073170 Al, published Mar. 29, 2007
("Dane horn").
4 Wangcai Liao et al., US 2008/0243016 Al, published Oct. 2, 2008
("Liao").
5 Stephan Joeken, US 2008/0033306 Al, published Feb. 7, 2008.
6 Neil R. Euliano et al., US 2004/0040560 Al, published Mar. 4, 2004
("Euliano").
7 Catherine A. Anderson et al., US 4,930,519, issued June 5, 1990
("Anderson").
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Application 12/638,658
Findings of Fact
We adopt the Examiner's findings and analysis concerning the scope
and content of the prior art. The following facts are repeated for reference
convemence.
1. Danehom teaches a "device for removing artefacts caused by
patient respiration in measured blood pressure data and in particular in blood
pressure data acquired invasively in the heart and/or an artery of the patient"
(Danehom i-f 2; see Ans. 3--4).
2. Danehom teaches that the
level of C02 in the patient's expired air is acquired as a
respiratory signal during the blood pressure measurement, and
the respiratory signal is used to approximate and remove the
artefacts caused by patient respiration. Hence, the invention
makes use of the relationship between respiration and the level
of C02 in the expired air.
(Danehom i-f 11.)
3. Danehom teaches that "the level of C02 is measured over
several breaths, and the respiratory frequency is extracted from the
respiratory signal .... The respiratory frequency is then used to derive a
model for the respiratory artefacts, and the model is subtracted from the
measured blood pressure data" (Danehom i-f 13).
4. Danehom discloses
a device for acquiring and correcting blood pressure data, having
a catheter insertable into the heart or an artery for measuring
blood pressure, the device further containing a sensor for
measuring the level of C02 in the patient's expired air as a
respiratory signal, and a data processing module for removing
artefacts in the measured blood pressure data, wherein the data
processing module is adapted to use the respiratory signal to
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Application 12/638,658
approximate and to remove the artefacts caused by patient
respiration.
(Danehom i-f 20; see Ans. 4.)
5. Liao teaches the use of "a pulmonary artery pressure signal to
detect and/or monitor physiological parameters" (Liao, Abstract). "[T]he
invention includes a method of measuring a pulmonary function parameter
of a patient including chronically implanting a pulmonary artery pressure
sensor, obtaining a pulmonary artery pressure signal from the pressure
sensor, and processing the signal to obtain the pulmonary function
parameter" (Liao i-f 5; see Ans. 4).
6. Liao teaches that the "hemodynamic information that can be
obtained with a coronary artery pressure sensor can include the systolic
pulmonary artery pressure at end-expiration, the diastolic pulmonary artery
pressure at end-expiration, [and] the mean pulmonary artery pressure,"
among others (Liao i-f 34).
7. Liao teaches that
it has been discovered that a pulmonary artery pressure signal
can be processed in order to determine or estimate one or more
parameters of pulmonary function ("pulmonary function
parameters"). Pulmonary artery pressure is modulated by
intrathoracic pressure, which changes with inspiration and
expiration. Specifically, intrathoracic pressure is increased
during expiration and decreased during inspiration. The
relationship between pulmonary artery pressure and intrathoracic
pressure can be used in a method in order to derive one or more
pulmonary function parameters.
(Liao i-f 35; see Ans. 4.)
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8. Liao teaches that "[m]any different pulmonary function
parameters can be calculated or estimated by processing a pulmonary artery
pressure signal," including, for example, respiration waveforms, tidal
volume, and forced expiration volume in one minute (FEV 1) (Liao i-f 3 7; see
Ans. 4).
9. Figure 3 of Liao, reproduced below shows "an idealized
pulmonary artery pressure signal and a respiration signal derived from the
pulmonary artery pressure signal" (Liao i-f 13; see Ans. 5).
"Respiration line 104 illustrates a roughly sinusoidal respiratory artifact that
is superposed on pulmonary artery pressure and is caused by changes in
intrathoracic pressure during the respiration cycle" (id. i-f 39). "The contours
of the respiration line 104 over time can be referred to as the respiration
waveform. The slope of the respiration line 104 as it is rising (as during
expiration) and as it is falling (as during inspiration) can be tracked and
recorded" (id. i-f 40). "The time for each cycle of respiration (both expiration
and inspiration) can be determined by measuring the amount of time 106 in
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Application 12/638,658
between successive peaks (or valleys) of the respiration line 104" (id. i-f 41;
see Ans. 4).
10. Liao explains that "[ d]ata from the air flow meter can be used to
accurately calculate the actual tidal volume. The recorded pulmonary artery
signal can then be calibrated to the actual tidal volume as indicated by the air
flow meter" (id. i-f 43).
Analysis
The Examiner finds that Danehom discloses "a device with two
sensors; a catheter for sensing invasive blood pressure, and a sensor for
measuring C02 as a respiratory signal" (Ans. 3--4 (citing Danehom, Abstract
and i-f 2)). The Examiner finds that Danehom discloses "a data processing
module for removing respiratory artifacts, in the invasive blood pressure
measurements, using the respiratory data" (Ans. 4 (citing Danehom,
Abstract, i-fi-12 and 20); see FF 1--4). According to the Examiner,
"Danehom's device involves identification of respiratory frequency ...
and/or heart rate" (Ans. 4 (citing Danehom, Abstract, i-fi-128, 29, 46, and
4 7) ). The Examiner finds that Danehom' s device determines "the actual
blood pressure by removing respiratory disturbances from the measured
blood pressure" (Ans. 4 (citing Danehom i-fi-130-32, Fig. 3, and Claim 16);
see FF 4). The Examiner finds that "Danehom does not teach using the
removed respiratory disturbances as an obtained respiratory function signal"
(Ans. 4) (emphasis added). In other words, Danehom does measure
respiratory frequency, but the reference does not keep the data from each
sensor separately and uses the respiratory frequency to remove artifacts from
the blood pressure signal (FF 4). The Examiner finds that Liao discloses "a
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method of measuring a pulmonary function parameter by processing a
pulmonary artery pressure signal" (Ans. 4 (citing Liao i-fi-15, 35, and 37 and
Claim 1 ); see FF 5-9). According to the Examiner, "[ w ]hat Liao does add to
Danehom, is keeping the respiratory data extracted from measured invasive
blood pressure data as a respiration signal, rather than removing it as noise"
(Ans. 9-10 (citing Liao i-fi-15 and 35 and Claim 1)).
Appellant argues that Danehom discloses "a device for obtaining
blood pressure data ... [and] the present application is directed to an
apparatus that measures a respiratory function. Thus, Danehom is direct[ ed]
to a different type of apparatus" than the instantly claimed invention (App.
Br. 11 ). Appellant argues that Danehom does not "teach or suggest 'a
second sensor configured to measure frequency of at least one of a heart beat
and a respiration,' as recited in claim 1" (App. Br. 11-12; see also Reply Br.
3). Appellant argues that because "Danehom does not provide a 'frequency
measured by the second sensor,"' Danehom does not "teach or suggest 'a
controller configured to obtain a respiratory function signal from the
invasive blood pressure detected by the first sensor, by using at least one of
the frequency measured by the second sensor and a harmonic of the
frequency,' as recited in claim 1" (App. Br. 12; see also Reply Br. 3).
Appellant argues that Liao "does not disclose 'a second sensor configured to
measure frequency of a least one of a heart beat and a respiration"' (App. Br.
12; see also Reply Br. 3).
Appellant's arguments are not persuasive. "The combination of
familiar elements according to known methods is likelv to be obvious when
~ ~
it does no more than yield predictable results.~' KSR Int 'l Co. v. Tele/lex
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inc., 550 U.S. 398, 416 (2007). Liao discloses that the measurement of
pulmonary artery blood pressure can be used to obtain both hemodynamic
information and information on pulmonary function parameters due to the
fact that pulmonary artery pressure is modulated by intrathoracic pressure,
which changes with inspiration and expiration (FFs 5-10). Liao discloses
that the relationship between pulmonary artery pressure and intrathoracic
pressure can be used to derive one or more pulmonary function parameters
(FF 7). Although Liao does not disclose the use of two separate sensors,
Danehom discloses a device for removing artefacts caused by patient
respiration in blood pressure measurement data that uses one sensor to
measure blood pressure in an artery and a second sensor to measure
expiration C02 and provide the respiration frequency (FFs 1--4). Because
Liao and Danehom both disclose analyzing a blood pressure signal to
determine the respiratory component of a blood pressure measurement, it
would have been obvious to one of skill in the art to use Danehom's
apparatus in Liao' s method so that respiration frequency as determined by
C02 measurement could be used to verify the respiration component that is
observed in Liao's analysis of pulmonary artery pressure (FF 9).
Appellant's arguments that Danehom does not disclose a second
sensor for measuring respiration frequency is also not persuasive because
Danehom discloses that the C02 level is measured over several breaths to
provide a respiratory frequency, which is then used to model and remove the
respiratory artefacts in the blood pressure measurement (FF 3).
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Thus, we affirm the rejection of claim 1 under 35 U.S.C. § 103(a).
Claims 2-10 have not been argued separately and therefore fall with claim 1.
See 37 C.F.R. § 41.37(c)(l)(iv).
II.
Issue
The Examiner has rejected claim 11 under 35 U.S.C. § 103(a) as
obvious over Danehom, Liao, and Joeken (Ans. 6-7).
The issue is: Does the evidence of record support the Examiner's
conclusion that the combination ofDanehom, Liao, and Joeken would have
made obvious a respiratory function measuring apparatus comprising "a
respiration determiner configured to ... determine whether the respiration is
spontaneous respiration or artificial respiration," as claimed?
Findings of Fact
11. Joeken discloses an apparatus that "determines the breathing
cycle from the central venous pressure signal. ... Summation/integration
over (at least part of) the respiratory power spectrum delivers the respiratory
power" (Joeken i-f 48). Joeken discloses that the "heart rate is determined
from the arterial pressure signal . . . [and the] cardiac power spectrum is
determined" (Joeken i-f 49). "[T]he ratio of respiratory and cardiac power is
provided as a measure of volume responsiveness" (Joeken i-f 50).
12. Joeken discloses that the "power spectra can be characterized
with respect to the kind of breathing (mechanically ventilated or
spontaneous)" (Joeken i-f 52). "Controlled ventilation typically differs from
spontaneous breathing by a smaller full width at half maximum WR and a
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slower decrease of log SR(t) with respect of log fat higher frequencies"
(Joeken i-f 53).
Analysis
Appellant argues that Joeken discloses a "blood pressure measurement
device and, as such, fails to make up for the ... deficiencies of Danehom
and Liao" (App. Br. 13). Appellant argues that Joeken does not "disclose or
teach at least the feature of 'a controller configured to obtain a respiratory
function signal from the invasive blood pressure detected by the first sensor'
as recited in claim 1" (id.).
Appellant's argument is not persuasive because, as discussed above,
we have concluded that claim 1 would have been obvious in view of the
Danehom and Liao.
Appellant argues that "it would not have been obvious to combine and
modify Danehom, Liao and Joeken to arrive at the subject matter of claim
11" (App. Br. 13). Appellant argues that the rejection is conclusory and
relies on impermissible hindsight (id.).
The Examiner responds that all three references, Danehom, Liao, and
Joeken, disclose "extracting respiration data flro]m invasive blood pressure
[measurements], making them analogous art" (Ans. 10). According to the
Examiner, "Joeken adds to Danehom and Liao by teaching identification of
spontaneous vs. artificial respiration as an improvement on such extraction
methods due to known differences between spontaneous and artificial
respiration" (Ans. 10 (citing Joeken, Abstract, i-fi-148-54, Figs. 3 and 4); see
FFs 11 and 12).
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Application 12/638,658
We agree with the Examiner's reasoning and conclusion. As
discussed above, Liao discloses monitoring of pulmonary artery pressure to
estimate parameters of pulmonary function. J oeken discloses monitoring
central venous pressure to determine the respiratory power spectrum (FF
11 ), and discloses that the respiratory power spectrum will indicate whether
breathing is spontaneous or mechanically ventilated (FF 12). We agree with
the Examiner that it would have been obvious to modify the apparatus made
obvious by Danehom and Liao to further comprise a respiration determiner
configured to determine whether the respiration is spontaneous or artificial
because Joeken discloses that such information can be obtained by
monitoring blood pressure, and one of skill the art would have appreciated
that determining the mode of breathing, i.e., either spontaneous or artificial
to be relevant to the determination of pulmonary function parameters (see
Ans. 7).
Accordingly, we affirm the rejection of claim 11 under 35 U.S.C.
§ 103(a) over the combination of Danehom, Liao, and Joeken.
III.
Issue
The Examiner has rejected claims 12 and 15 under 35 U.S.C. § 103(a)
as obvious in view of Danehom, Liao, and Euliano (Ans. 7-8).
The issue is: Does the evidence of record support the Examiner's
conclusion that the combination of Danehom, Liao, and Euliano would have
made obvious the respiratory function measuring apparatus as claimed?
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Findings of Fact
13. Euliano discloses a "method of estimating the actual patient
effort parameter using a combination of multiple parameters derived from
sensors that monitor the patient and/or ventilator" (Euliano i-f 19). "The
patient effort parameter can be any parameter that represents the effort
exerted by the patient to breathe, including but not limited to work of
breathing, power of breathing, or pressure time product" (Euliano i-f 19).
14. Euliano discloses that
the parameters are preferably derived from the airway pressure,
flow, and volume waveforms and the carbon dioxide and pulse
oximeter waveforms normally collected by a respiratory
monitor, including but not limited to tidal volume, breathing
frequency, peak inspiratory pressure (PIP), inspiratory time,
PO .1, trigger time, trigger depth, respiratory system resistance,
respiratory compliance, end-tidal carbon dioxide, variations in
the pulse oximeter plethysmogram, and the concavity/convexity
of the pressure waveform.
(Euliano i-f 20.)
15. Euliano discloses that, "[i]n the embodiment depicted in FIG.
2, a patient 10 requiring respiratory support and connected to a ventilator 12
will have an airway flow and pressure sensor 14, along with possibly a
carbon dioxide detector attached at the y-piece of the standard ventilator
circuit 16" (Euliano i-f 40). "These sensors measure the flow, pressure, and
partial pressure of carbon dioxide in the gases that pass to and from the
patient. ... These signals are then processed in a parameter extraction
module 22 to calculate a variety of other parameters from the flow, pressure,
and C02 data" (Euliano i-f 40). "For example ... peak inspiratory pressure is
calculated by determining the maximum pressure during a breath; PO. I is
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calculated by measuring the change in airway pressure during the first tenth
of a second of a breath" (Euliano i-f 40).
Analysis
Appellant argues that "it would not have been obvious to combine and
modify Danehom, Liao and Euliano to arrive at the subject matter of claims
12 and 15 because they are devices directed to completely different end
result objectives, i.e., blood pressure measurement and work of breathing
measurement" (App. Br. 14). Appellant argues that one could not arrive at
the present claims without the use of impermeable hindsight (id.).
Appellant's arguments are not persuasive. As discussed above (J.),
Liao discloses monitoring of pulmonary artery pressure to estimate
parameters of pulmonary function. Danehom in combination with Liao
would have made obvious the use of a second sensor to monitor expiration
C02 so that respiration frequency, as determined by C02 measurement,
could be used to verify the respiration component that is observed in Liao' s
analysis of pulmonary artery pressure. Euliano discloses that a respiratory
flow and pressure sensor combined with a C02 sensor can be used to provide
additional pulmonary parameters such as peak inspiratory pressure and PO. I,
which is the change in airway pressure during the first tenth of a second of a
breath (FF 13-15). We agree with the Examiner's conclusion that it would
have been obvious to include flow and pressure sensors to the apparatus of
Liao and Danehom in order to monitor additional parameters for improved
detection of irregular or interrupted breathing in a ventilated patient (Ans. 8).
Accordingly, we affirm the rejection of claims 12 and 15 under
35 U.S.C. § 103(a) over the combination ofDanehom, Liao, and Euliano.
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Issue
IV.
The Examiner has rejected claims 13 and 14 under 35 U.S.C. § 103(a)
as obvious in view ofDanehom, Liao, and Anderson (Ans. 8-11).
The issue is: Does the evidence of record support the Examiner's
conclusion that the combination ofDanehom, Liao, and Anderson would
have made obvious a respiratory function measuring apparatus comprising a
display to show the end-tidal?
Findings of Fact
16. The Specification discloses that the end-tidal is the inspiration
starting point (Spec. 13).
17. Liao discloses that graphs of respiration signals can be used to
show respiratory parameters (Liao, Figs. 4, 5, 7-11, and 13-15).
18. Figure 4 of Liao is shown below:
FIG. 4 is "a graph showing an idealized respiration signal during normal
breathing and during a forced expiration maneuver" (Liao i-f 14). Liao
discloses that, in Figure 4, "a graph is shown of a respiration signal 150
during normal breathing 152 and during forced expiration 154. The forced
expiration amplitude 158 of the respiration signal 150 can be tracked and
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compared with the normal breathing amplitude 156 of the respiration signal
150" (Liao ii 46).
19. Anderson discloses a "method of graphically displaying
cardiopulmonary function data by providing a plurality of axes radially
projecting from a common point of origin" (Anderson, Abstract). "The
cardiopulmonary function data to be displayed are then plotted ... [and]
deviations of any such data from normal will result in an irregular polygon
... [which] provides a clinician with a readily visible display of possible
cardiopulmonary d[y]sfunction" (Anderson, Abstract).
20. Anderson discloses that, although tabular data and plots can be
interpreted with the trained eye, "that task is simplified by a display method
which tends to magnify or highlight deviations of actual measured
parameters from the norm" (Anderson, col. 3, 11. 55---60).
Analysis
Appellant contends that "Anderson also fails to supply the
deficiencies of Danehom and Liao as described above in connection with
claim 1" (App. Br. 15). Appellant argues that "it would not have been
obvious to combine and modify Danehom and Liao with Anderson to arrive
at the subject matter of claims 13 and 14" (id.).
Appellant's arguments are not persuasive. Liao discloses the use of
graphs of the respiratory signal or waveform to display and highlight
functional parameters of respiration (FFs 17-18). One of skill the art would
appreciate that marks highlighting the end-tidal volume would be useful to
indicate changes to the respiratory signal. Anderson discloses that data
interpretation can be simplified by display methods using graphs that
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magnify and highlight particular data features (FFs 19-20). In view of this
disclosure in Liao and Anderson, we agree with the Examiner's conclusion
that the combination of Danehom, Liao, and Anderson would have made
obvious a respiratory function apparatus with displays configured to show
the inspiration stating point.
Accordingly, we affirm the rejection of claims 13 and 14 under
35 U.S.C. § 103(a) over the combination ofDanehom, Liao, and Anderson.
SUMMARY
We affirm the rejection of claims 1-15 under 35 U.S.C. § 103(a).
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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