Ex Parte Olde et al

Patent Trial and Appeal Board

Jan 29, 2019

13519067 (P.T.A.B. Jan. 29, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/519,067 08/23/2012
26813 7590 01/31/2019
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Bo Olde
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.
PN1088US (405.00620101) 7688
EXAMINER
ALTER, MITCHELLE
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
01/31/2019 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):
ptodocketing@mrgs.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BO OLDE and KRISTIAN SOLEM
Appeal2018-004375
Application 13/519,067 1
Technology Center 3700
Before STEFAN STAICOVICI, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Bo Olde and Kristian Solem ("Appellants") appeal under 35 U.S.C.
§ 134(a) from the Examiner's decision in the Final Office Action (dated
March 7, 2017, hereinafter "Final Act.") rejecting claims 1-3, 6-10, 12-18,
and 38-52. 2 We have jurisdiction under 35 U.S.C. § 6(b).
SUMMARY OF DECISION
We AFFIRM.
1 According to Appellants' Appeal Brief ( dated Aug. 14, 2017, hereinafter
"Appeal Br.") Gambro Lundia AB is the real party in interest. Appeal Br. 2.
2 Claims 4, 5, 11, and 19-37 are canceled. Id.
Appeal2018-004375
Application 13/519,067
INVENTION
Appellants' invention relates to a monitoring apparatus for "detection
of the onset of rapid (i.e. acute) symptomatic drop in a subject's blood
pressure." Spec. 1, 11. 5-7.
Claims 1 and 3 8 are independent. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A monitoring arrangement for predicting a symptomatic
blood pressure decrease in a subject, the monitoring arrangement
compnsmg:
a pulse recording apparatus configured to repeatedly
register a pulse shape parameter in a peripheral body part of the
subject based on a pulse signal, wherein each registered pulse
shape parameter is a sequence of signal values in a respective
time window representing a segment in the pulse signal, wherein
the pulse recording apparatus comprises a pulse oximetry
instrument configured to register the pulse shape parameter
based on light response variations in at least one blood vessel of
the subject, and
a control unit configured to receive a plurality of pulse
shape parameters registered by the pulse recording apparatus,
wherein each received pulse shape parameter represents a
different sequence of signal values, the control unit comprising a
processing unit configured to:
calculate, during a measurement period, a plurality
of pulse magnitude measures, each calculated pulse
magnitude measure based on a different received pulse
shape parameter registered by the pulse recording
apparatus,
calculate a statistical dispersion measure from the
plurality of calculated pulse magnitude measures,
investigate whether the calculated statistical
dispersion measure fulfils a statistical measure decision
criterion relative to a reference predetermined statistical
dispersion measure, and
generate an output signal indicating a prediction of
a symptomatic blood pressure decrease in the subject
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Application 13/519,067
based on the calculated statistical dispersion measure
fulfilling the decision criterion relative to the reference
predetermined statistical dispersion measure, wherein the
output signal comprises an alarm triggering signal
prompting performance of at least automatic actions, and
wherein the monitoring arrangement is connected to a
dialysis machine comprising one or more systems in the dialysis
machine configured to be activated by the alarm triggering signal
to automatically perform at least one of a plurality of actions to
counter-act an occurrence of a hypotension event in response to
generation of an output signal indicating a prediction of a
symptomatic blood pressure decrease in the subject, wherein the
plurality of actions to counter-act an occurrence of a hypotension
event comprises adjusting a rate of fluid removal from the subject
by reducing and/ or stopping a rate of fluid removal, increasing a
conductivity in a dialysis fluid, supplying a saline bolus to a
blood line connected to the cardiovascular system of the subject,
adjusting a position of a controllable structure supporting the
subject, and setting a dialysis monitor in bypass.
REJECTIONS
I. Claims 1-3, 6-10, 12-18, and 38-52 are rejected under 35 U.S.C.
§ I03(a) as unpatentable over Sommo et al. (US 2009/0272678 Al,
pub. Nov. 5, 2009, hereinafter "Sommo"), Al-Ali et al. (US
2008/0188733 Al, pub. Aug. 7, 2008, hereinafter "Al-Ali"), Mancini
et al. (E Mancini, Short Term Variability of Oxygen Saturation During
Hemodialysis is a Warning Parameter for Hypotension Appearance,
Computers in Cardiology, 35:881-883 (2008), hereinafter "Mancini"),
Storm (US 2011/0144523 Al, pub. June 16, 2011), and Bassale (Jules
Bassale, Hypotension Prediction Arterial Blood Pressure Variability,
Electrical and Computer Engineering, Portland State University ECE
457: Leaming From Data (Spring 2001)).
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Application 13/519,067
II. Claims 1-3, 6-10, 12-18, and 38-52 are provisionally rejected on the
ground of non-statutory double patenting as being unpatentable over
claims 1-37 of copending U.S. Application No. 13/519,559.
ANALYSIS
Rejection I
Appellants do not present arguments for the patentability of claims 2,
3, 6-10, 12-18, and 38-52 apart from claim 1. See Appeal Br. 6-16.
Therefore, in accordance with 37 C.F.R. 4I.37(c)(l)(iv), we select claim 1 as
the representative claim to decide the appeal, with claims 2, 3, 6-10, 12-18,
and 38-52 standing or falling with claim 1.
The Examiner finds that Sommo discloses a monitoring apparatus for
"predicting rapid symptomatic blood pressure decrease in a subject"
including, inter alia, a processing unit configured to calculate a plurality of
pulse magnitude measures that are used to generate an output signal
indicating the prediction of asymptomatic blood pressure decrease in the
subject. Final Act. 3--4 ( emphasis omitted). However, the Examiner finds
that Sommo does not "calculate a statistical dispersion measure from
plurality of calculated pulse magnitude measures," 3 as recited by claim 1, to
generate the output signal. Id. at 5. Thus, the Examiner turns to Al-Ali,
which, the Examiner finds, discloses "calculate[ing] a statistical dispersion
measure from pulse plurality of calculated pulse magnitude measures from a
3 Appellants' Specification describes a statistical dispersion measure as "any
measure that represents a variability or spread of a sequence of values," such
as "standard deviation ( a), variance ( 0 2), coefficient of variation ( a/µ) and
variance-to-mean ( 0 2/ µ)," and may also include "normalized and/or
weighted variants." Spec. 17, 11. 1-5, 14.
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pulse oximeter ... for the purpose [ of] generating an output signal indicating
a prediction of the physiological condition of a patient." Id. at 5. The
Examiner further employs Bassale, Storm, and Mancini as evidence that
calculating a statistical dispersion measure is well known. Id. at 6. Hence,
the Examiner concludes that it would have been obvious to a person of
ordinary skill in the art to modify the apparatus of Sommo to calculate a
statistical dispersion from the plurality of calculated pulse magnitude
measures, as taught by Al-Ali, to generate an output signal indicating a
prediction of a symptomatic blood pressure decrease in the patient. Id.
According to the Examiner, the modification is "for the predictable purpose
of generating an output signal indicating a prediction of the physiological
condition of a patient based on the calculated statistical dispersion measure."
Id.
Appellants argue that Al-Ali's broad disclosure of a statistical
dispersion is insufficient to establish that "a statistical dispersion of a
plurality of calculated pulse magnitude measures would necessarily result in
being able to predict a symptomatic blood pressure decrease," and, thus, Al-
Ali is deficient in supporting the Examiner's modification for the following
reasons. Appeal Br. 9-10. First, Appellants argue that Al-Ali provides "an
early warning of a slowly deteriorating patient condition," whereas Sommo
detects "the rapid onset of symptomatic blood pressure decrease." Id. at 10.
Second, Appellants contend that Al-Ali "only uses blood pressure (BP) as an
input parameter," but does not predict symptomatic blood pressure decrease.
Id. Third, Appellants assert that Al-Ali does not use a pulse magnitude
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measure4, but rather uses "multiple types of parameters (e.g., Sp02 and pulse
rate) to predict patient condition instead." Id. Appellants' fourth argument
is that Al-Ali does not use pulse shape parameters5 as an input. Id. As to
the disclosures of Bassale, Storm, and Mancini, Appellants argue that they
do not remedy the shortcomings of Sornmo and Al-Ali because these
references do not disclose "a calculated statistical dispersion measure ( which
is calculated from the plurality of pulse magnitude measures) in the
prediction of a symptomatic blood pressure decrease in a subject." Id. at 10-
11.
We are not persuaded by Appellants' arguments because Appellants
cannot show nonobviousness by attacking Sommo, Al-Ali, Bassale, Storm,
and Mancini individually when the rejection as articulated by the Examiner
is based on a combination of these references. See In re Merck & Co. Inc.,
800 F.2d 1091, 1097 (Fed. Cir. 1986). In this case, Sommo discloses
"predict[ing] rapid symptomatic blood pressure decrease in the subject P
based on an initial pulse magnitude measure PMl calculated from a pulse
shape parameter pps." Sommo, para. 40; see also Examiner Answer (dated
Jan. 25, 2018, hereinafter "Ans.") at 2. Al-Ali discloses that physiological
parameters, such as "pulse rate," are used as inputs to generate outputs
including "alarms, diagnostics and controls," and that the data is
"normalized" and used to "calculate averages, variances, and/or other
analytical measures of various physiological parameters over time." Al-Ali,
4 "[T]he pulse magnitude measure PM represents the magnitude of the signal
values in the signal segment." Spec. 9, 11. 23-24.
5 "[A] 'pulse shape parameter pps' refers to a signal segment in, or derived
from, the pulse signal S, i.e. a sequence of signal values within a time
window." Spec. 9, 11. 16-17.
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paras. 7, 53, 67, and 84; see also Ans. 2-3. As the data in Al-Ali is
"normalized" and used to "calculate averages, variances, and/or other
analytical measures," a person of ordinary skill in the art would readily
appreciate that Al-Ali discloses calculating a statistical dispersion measure. 6
See e.g., In re Jacoby, 309 F.2d 513,516 (CCPA 1962). Bassale, Storm, and
Mancini disclose that calculating a statistical dispersion measure and
generating an output signal based on the calculated statistical dispersion
measure are well known. See Ans. 3 ( citing Bassale, Abstract; Storm, para.
27; Mancini, p. 882).
As such, Sommo uses pulse magnitude measures to predict
symptomatic blood pressure decrease, Al-Ali calculates a statistical
dispersion measure using normalized or averaged pulse rate data to generate
outputs including "alarms, diagnostics and controls," and Bassale, Storm,
and Mancini disclose calculating a statistical dispersion measure and
generating an output signal based on the calculated statistical dispersion.
Therefore, the Examiner has a sound basis for determining that a skilled
artisan would use Sommo' s pulse magnitude measures to calculate a
statistical dispersion measure, as taught by Al-Ali, in order to modify
Sommo's output signal to indicate a prediction of symptomatic blood
pressure decrease in a patient. See Ans. 4. Accordingly, the Examiner is on
solid footing to shift the burden to Appellants to show that Sommo' s pulse
6 Similarly, Appellants' Specification describes a statistical dispersion
measure as "any measure that represents a variability or spread of a
sequence of values," such as "standard deviation (a), variance ( 0 2),
coefficient of variation (a/µ) and variance-to-mean (02/µ)," and may also
include "normalized and/or weighted variants." Spec. 17, 11. 1-5, 14
( emphasis added).
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magnitude data when subjected to Al-Ali's statistical dispersion is incapable
of predicting a physiological condition, such as, symptomatic blood pressure
decrease, in a patient. In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
Furthermore, we note that the Examiner's modification is an
improvement to Sommo's data analysis to normalize the data in the same
way as taught by Al-Ali, that is, to decrease incidence of false alarms and/or
more effectively determine the wellness of the patient (see Al-Ali, paras. 46,
49) which leads to a predictable result, and the modification is well within
the skill of a person of ordinary skill in the art. KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007) ("[I]f 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.").
Appellants further argue that "the Examiner has not provided a clear,
evidence-supported account of the contemplated workings of the proposed
combination of Sommo, Al-Ali, Bassale, Storm, and Mancini to support the
conclusions of motivation and a reasonable expectation of success." Appeal
Br. 14. According to Appellants, the Examiner's rejection would not have
motivated a person of ordinary skill to arrive at the pending claims and that
one of ordinary skill would not have expected success. Id. at 15. Appellants
contend that although Al-Ali calculates "analytical measures of various
physiological parameters over time ... Al-Ali does not describe using the
calculated variances to indicate a prediction of a physiological condition,"
and specifically does not predict a symptomatic blood pressure decrease in
the subject based on the calculated statistical dispersion measure as claimed.
Reply Brief (filed Mar. 21, 2018, hereinafter "Reply Br.") at 2.
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Appellants' arguments are not persuasive, because, as the Examiner
correctly notes, Sommo already discloses predicting a symptomatic blood
pressure decrease in a patient based on a pulse magnitude measure. See Ans.
7. Here, in the rejection, the Examiner is merely applying Al-Ali's statistical
dispersion measure to the data that Sommo already measures. As such, the
Examiner is correct that a person of ordinary skill in the art would readily
appreciate that using normalized data, that is, data that has been subject to
statistical dispersion, as taught by Al-Ali, in Sommo' s monitoring apparatus,
would predict a symptomatic blood pressure decrease in a patient. See Ans.
8. Absolute predictability of predicting a symptomatic blood pressure
decrease is not required; all that is required is a reasonable expectation of
success. See In re O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988). In
addition, Al-Ali discloses that signals from sensors "may be sampled,
normalized, and/or analyzed" and that "normalization of sensor signals"
provides "benefits, such as decreased incidence of false alarms and/ or more
effective determination of the wellness of the patient." Al-Ali, paras. 42, 81.
As such, modifying Sommo' s monitoring apparatus, according to Al-Ali,
provides the added benefit of decreased false alarms.
In conclusion, for the foregoing reasons, we sustain the rejection of
claim 1 under 35 U.S.C. § 103(a) as unpatentable over Sommo, Al-Ali,
Mancini, Storm and Bassale. Claims 2, 3, 6-10, 12-18, and 38-52 fall with
claim 1.
Rejection II
As Appellants do not present any arguments with respect to the
provisional rejection of claims 1-3, 6-10, 12-18, and 38-52 on the ground
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of non-statutory double patenting as unpatentable over claims 1-37 of
copending U.S. Application No. 13/519,559, we summarily sustain this
rejection as well. See Appeal Br. 6.
DECISION
The Examiner's decision to reject claims 1-3, 6-10, 12-18, and 38-
52 under 35 U.S.C. § 103(a) as unpatentable over Sommo, Al-Ali, Mancini,
Storm, and Bassale is affirmed.
The Examiner's decision to reject claims 1-3, 6-10, 12-18, and 38-
52 on the ground of non-statutory double patenting over claims 1-37 of
copending U.S. Application No. 13/519,559 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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