SOTERA WIRELESS, INC.

Patent Trials and Appeals Board

Dec 17, 2021

2021004798 (P.T.A.B. Dec. 17, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
16/017,305 06/25/2018 Devin McCombie TWI-90000-CT 8538
35938 7590 12/17/2021
Acuity Law Group, P.C.
12707 High Bluff Drive
Suite 200
San Diego, CA 92130-2037
EXAMINER
VOORHEES, CATHERINE M
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
12/17/2021 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@acuitylg.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DEVIN McCOMBIE and GUANQUN ZHANG

Appeal 2021-004798
Application 16/017,305
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, KENNETH G. SCHOPFER, and
BRADLEY B. BAYAT, Administrative Patent Judges.

SCHOPFER, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claim 1. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Sotera
Wireless, Inc. Appeal Br. 4.
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BACKGROUND
The Specification discloses that the “invention provides a method and
system for calibrating a body-worn vital sign monitor configured to
determine a continuous noninvasive blood pressure measurement using
pulse pressure wave data.” Spec. ¶ 7.
CLAIM
Claim 1 is the only claim on appeal and recites:
1. A method of determining patient-specific calibration
values for use in a continuous blood pressure measurement based
on pulse wave velocity (PWV), the method comprising:
positioning on the patient
(i) a sensor device on a patient, the sensor device
configured to measure sensor data indicative of pulse
arrival time (PAT) at a first point on an extremity of the
patient, the PAT defined as a time difference between
ventricular depolarization occurring in a cardiac cycle, and
arrival of a pressure wave at the first point resulting from
blood flow caused by the ventricular depolarization
through a vascular path of length (Lt), wherein the sensor
device is operably connected to a processing component,
and
(ii) an inflatable cuff device on the patient's
extremity at a second point on the extremity of the patient
at a position on the vascular path between the heart and the
first point, the inflatable cuff device comprising an
inflatable cuff which is configured to cover a portion of
the vascular path of length (Lc) and an inflation pump, the
inflatable cuff device configured to measure a waveform
indicative of cuff pressure on the patient’s extremity
during inflation, wherein the inflatable cuff device is
operably connected to the processing component;
receiving at the processing component the sensor data and
the waveform indicative of cuff pressure, and causing the
processing component to calculate therefrom a series of pulse
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arrival times (“PATs”) as a function of cuff pressure during
inflation of the inflatable cuff to above the patient’s systolic
blood pressure, wherein the inflation causes a compliance change
in the vascular path of length L2, thereby causing the PAT
measured by the sensor device to lengthen as cuff pressure is
increased; and
determining using the processing component one or more
coefficients which relate PWV to mean arterial pressure (MAP)
by modeling the series of PATs measured as a function of cuff
pressure as a nonlinear relationship.
Appeal Br. 13.
REJECTION
The Examiner rejects claim 1 under 35 U.S.C. § 103 as unpatentable
over Banet2 in view of Karst3 and Geddes.4
DISCUSSION
With respect to claim 1, the Examiner finds that Banet teaches a
method as claimed except that Banet “does not explicitly describe
coefficients or calibrations which relate pulse wave velocity (PWV) to mean
arterial pressure by modeling the series of PATs measured as a function of
cuff pressure as a nonlinear relationship.” Final Act. 5–6 (citing Banet
Figs. 1, 8; ¶¶ 3, 4, 6, 7, 11, 30–33, 36–39, 47, 48, 50, 51, 57–59). The
Examiner finds that “Banet does describe providing a PWV . . . and that PPT
can estimate changes in blood pressure values.” Id. (citing Banet ¶ 11). The
Examiner also finds that Banet depicts the relationship between blood

2 Banet et al., US 2009/0018422 A1, pub. Jan. 15, 2009.
3 Karst et al., US 2012/0215117 A1, pub. Aug. 23, 2012.
4 Geddes et al., Vol. 18. No. 1 Pulse Transit Time as an Indicator of Arterial
Blood Pressure PSYCHOPHYSIOLOGY 71–74 (1981).
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pressure and pulse transit time (PTT) as non-linear and does not limit
modeling of this relationship to a linear function. Id. at 3 (citing Banet
¶¶ 57, 58).
The Examiner relies on Karst as disclosing “systems and methods for
estimating central arterial blood pressure . . . where determination of pulse
arrival times (PAT) are known to determine how long it takes a pulse wave
to travel from one point to another when estimating pulse wave velocity or
blood pressure.” Id. (citing Karst, Abs.; ¶¶ 4, 5). The Examiner relies on
Geddes as teaching “that PTT and PWV, respectively, were shown to [have]
a correlation with systolic blood pressure and are suitable for indirect blood
pressure measurements . . . and that the pulse wave velocity varies non-
linearly with diastolic blood pressure.” Id. at 7 (citing Geddes Abs., 3).
Based on these findings, the Examiner determines that “[i]t would
have been obvious to one of ordinary skill in the art to present the function
in regards to PWV instead of blood pressure depending on the nomenclature
preference of the end user.” Final Act. 6. The Examiner also determines:
It would have been further obvious to one skilled in the art to
modify the method of Banet in view of Karst to provide the a
calibration formula which relates PWV to MAP by modeling the
series of PATs measured as a function of cuff pressure as a
nonlinear relationship as taught by [Geddes] . . ., and because the
combination would have yielded predictable results.
Id. at 7.
We are persuaded of error in the rejection of claim 1 because we agree
with Appellant that the rejection, as summarized above, fails to set forth a
prima facie case of obviousness. See Appeal Br. 7–12. The USPTO carries
its procedural burden of establishing a prima facie case when its rejection
satisfies the requirements of 35 U.S.C. § 132 by notifying the applicant of
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the reasons for rejection, “together with such information and references as
may be useful in judging of the propriety of continuing the prosecution of
[the] application.” In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011)
(brackets in original) (quoting 35 U.S.C. § 132(a)).
Here, the Examiner has failed to adequately explain how the rejection
proposes to combine the references to provide a method including the step of
“determining using the processing component one or more coefficients
which relate PWV to mean arterial pressure (MAP) by modeling the series
of PATs measured as a function of cuff pressure as a nonlinear relationship,”
as required by claim 1. We agree with Appellant that there are several errors
or gaps in the rejection that prevent us from determining how the Examiner
proposes that the art of record renders this method step obvious. See Appeal
Br. 7–12.
With respect to Banet, the Examiner finds that “Banet discloses a
method of determining patient-specific calibration values in a continuous
blood pressure measurement based on pulse wave velocity.” Final Act. 4
(citing Banet ¶¶ 7, 11)(emphasis added). At paragraph 7, Banet discloses
that a patient’s vascular index (“VI”) “is used in combination with the
patient’s age to estimate their arterial properties,” which “are then used to
‘correct’ the blood pressure determination that was determined by” “PTT”).
Banet discloses that “PTT, VI and blood pressure, along with other
information such as pulse pressure, blood pressure variability, heart rate,
heart rate variability, respiratory rate, pulse oximetry, pulse wave velocity,
and temperature, are analyzed with a hand-held device that includes many
features of a conventional personal digital assistant (PDA).” Banet ¶ 11.
We fail to see how these paragraphs show that Banet discloses determining
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calibration values based on pulse wave velocity. Banet merely mentions
pulse wave velocity without further explanation.
The Examiner further indicates that because pulse wave velocity is
“an arterial property of the patient” and “Banet’s blood pressure value uses a
mathematical model that includes PTT (part of PAT) and the patient’s
arterial properties[, t]he blood pressure measurement of Banet includes pulse
wave velocity as set forth in paragraph [0011] of Banet.” Ans. 4. Although
pulse wave velocity may be considered an arterial property, Banet provides
no further discussion regarding pulse wave velocity beyond merely listing it
in paragraph 11, i.e., Banet neither provides any information regarding how
it is determined nor whether it is used in any calculation of blood pressure.
Next, regarding the Examiner’s reliance on Karst, it is not clear how
the Examiner is relying on Karst to cure any deficiency in Banet. The
Examiner finds that Karst teaches “methods for estimating central arterial
blood pressure of a patient where determination of pulse arrive times (PAT)
are known to determine how long it takes a pulse wave to travel from one
point to another point when estimating pulse wave velocity or blood
pressure.” Final Act. 6 (citing Karst Abs., ¶¶ 4, 5). The Examiner
determines that “[i]t would have been obvious to one of ordinary skill in the
art to present the function in regards to PWV instead of blood pressure
depending on the nomenclature preference of the end user (physician).” Id.
It is not clear to us how the Examiner is relying on Karst. The Examiner
does not explain what “function” would be presented “in regards to PWV
instead of blood pressure” or how that teaches or suggests the determining
step as claimed. The claim requires determining “one or more coefficients
which relate PWV to mean arterial pressure.” From this language, it does
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not appear that any function may be presented using PWV instead of blood
pressure but that there is a determination of some function that relates PWV
to blood pressure. Further, although the Examiner provides further
explanation in the Answer, i.e., that Karst teaches using PAT to estimate
PWV and then estimating blood pressure passed on PWV, the Examiner
fails to provide a reason to support why it would have been obvious to
modify Banet based on Karst. See Ans. 5.
Finally, the Examiner relies on Geddes as allegedly disclosing that
PTT and PWV were shown to correlate “with systolic blood pressure and are
suitable for indirect blood pressure measurement . . . and that the pulse wave
velocity varies non-linearly with diastolic blood pressure.” Final Act. 7.
The Examiner also finds that Geddes “uses a non-linear (logarithmic
mathematical function to determine its coefficients using PAT). Id. at 3. The
Examiner then determines that it would have been obvious “to provide the
calibration formula which relates PWV to MAP by modeling the series of
PATs measured as a function of cuff pressure as a nonlinear relationship as
taught by [Geddes] . . . because the combination would yield predictable
results.” Id. at 7. We have reviewed Geddes, and fail to see any disclosure
of a logarithmic mathematical function or a nonlinear relationship between
pulse wave velocity and diastolic blood pressure. We note that the claim
requires “modeling the series of PATs measured as a function of cuff
pressure as a nonlinear relationship” whereas Geddes discloses that “[a]
linear relationship was found between pulse-arrival time and mean blood
pressure” and that “the relationship between pulse-wave velocity and
diastolic pressure is very nearly linear.” Geddes p. 73. In other words, the
Examiner fails to show how Geddes cures any deficiency in Banet or Karst.
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Based on the foregoing, we determine that the Examiner has failed to
establish a prima facie showing of obviousness, and thus, we do not sustain
the rejection of claim 1.
CONCLUSION
We REVERSE the rejection of claim 1.
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1 103 Banet, Karst,
Geddes
1

REVERSED