Welch Allyn, Inc.

Patent Trials and Appeals Board

Mar 16, 2021

2020004536 (P.T.A.B. Mar. 16, 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.
14/450,510 08/04/2014 David E. Quinn 10156.0087US01 9908
92558 7590 03/16/2021
Merchant & Gould- Welch Allyn
P.O. Box 2903
Minneapolis, MN 55402
EXAMINER
PORTILLO, JAIRO H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
03/16/2021 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):
USPTO92558@merchantgould.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte DAVID E. QUINN
____________

Appeal 2020-004536
Application 14/450,510
Technology Center 3700
____________

Before JENNIFER D. BAHR, WILLIAM A. CAPP, and
CARL M. DEFRANCO, Administrative Patent Judges.

CAPP, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the final
rejection of claims 1, 3–7, 9–12, 14–18, 21, and 22. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Welch Allyn, Inc. as the Applicant
and real party in interest. Appeal Br. 3.
Appeal 2020-004536
Application 14/450,510
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THE INVENTION
Appellant’s invention relates to blood pressure cuffs. Spec. ¶¶ 1–4.
Claim 1, reproduced below, is illustrative of the subject matter on appeal.
1. A non-invasive blood pressure measurement and
orthostatic hypotension detection system for use on a human or
animal subject, the system comprising:
a processing unit;
a non-invasive blood pressure cuff configured to transmit a
blood pressure signal to the processing unit, wherein the blood
pressure cuff comprises:
an inflation component having a side defining an x-y
plane;
an air port on the inflation component, wherein the air
port comprises a center;
a coupling element rotatably coupled with the air port; and
a tubular element coupled with the coupling element;
a first altitude sensor positioned on the coupling element of
the blood pressure cuff such that a center of the first altitude
sensor is at a same location as the center of the air port in a y-
axis direction of the x-y plane of the inflation component,
wherein the first altitude sensor is configured to generate a first
height measurement and transmit the first height measurement
to the processing unit; and
a second altitude sensor separate from the blood pressure
cuff and configured to generate a second height measurement
and transmit the second height measurement to the processing
unit, wherein the second altitude sensor is configured to
connect with the human or animal subject at a level of the
subject’s heart,
wherein the processing unit is configured to determine a
height difference between the first and second height
measurements, calculate and store a blood pressure correction
parameter, and generate an adjusted blood pressure
measurement using the blood pressure correction parameter and
the blood pressure signal,
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wherein the processing unit is further configured to analyze
at least the blood pressure signal, the first height measurement,
and the second height measurement to detect orthostatic
hypotension in the human or animal subject, and
wherein the processing unit is further configured to analyze
the first height measurement and the second height
measurement, determine that the human or animal subject has
moved to a standing position, and automatically send a signal to
the blood pressure cuff to initiate a new blood pressure
measurement of the human or animal subject.
THE REJECTIONS
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Bridger US 6,491,647 B1 Dec. 10, 2002
Kato US 6,872,182 B2 Mar. 29, 2005
Banet US 2005/0216199 A1 Sept. 29, 2005
Tenzer US 2006/0036184 A1 Feb. 16, 2006
Fumuro US 2010/0312127 A1 Dec. 9, 2010
Moon US 2011/0066050 A1 Mar. 17, 2011
Kroll US 7,970,465 B1 June 28, 2011
Evans US 2012/0178689 A1 July 12, 2012
Baym US 2013/0116663 A1 May 9, 2013
Kiani US 8,740,792 B1 June 3, 2014
The following rejections are before us for review:
1. Claims 1 and 3–6 are rejected under 35 U.S.C. § 103 as being
unpatentable over Moon, Baym, Kato, Kroll, and Fumuro.
2. Claim 7 is rejected under 35 U.S.C. § 103 as being unpatentable
over Moon, Baym, Kato, Kroll, Fumuro, and Banet.
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3. Claims 9–11, 15, and 18 are rejected under 35 U.S.C. § 103 as
being unpatentable over Moon, Baym, Kato, Kroll, and Evans.
4. Claim 12 is rejected under 35 U.S.C. § 103 as being unpatentable
over Moon, Baym, Kato, Kroll, Evans, Fumuro, and Bridger.
5. Claim 14 is rejected under 35 U.S.C. § 103 as being unpatentable
over Moon, Baym, Kato, Kroll, Evans, Fumuro, and Banet.
6. Claims 16 and 17 are rejected under 35 U.S.C. § 103 as being
unpatentable over Moon, Baym, Kato, Kroll, Evans, Fumuro, and Tenzer.
7. Claims 21 and 22 are rejected under 35 U.S.C. § 103 as being
unpatentable over Moon, Baym, Kato, Kroll, Fumuro, and Kiani.
OPINION
Unpatentability of Claims 1 and 3–6
over Moon, Baym, Kato, Kroll, and Fumuro
Appellant argues claims 1 and 3–6 as a group. Appeal Br. 17–20.
Claim 1 is representative. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds that Moon discloses the invention substantially as
claimed except for an air port and first altitude sensor positioned as claimed
with a processing unit that determines a height difference. Final Act. 4–5.
The Examiner relies on Baym as teaching an altitude sensor coupled with a
blood pressure cuff to determine an adjusted measurement based on cuff
height. Id. at 5. The Examiner relies on Kato as generating an adjusted
blood pressure measurement using first and second height determinations.
Id. at 6. The Examiner relies on Kroll as detecting orthostatic hypotension
by analyzing blood pressure signals and different height measurements. Id.
at 9. The Examiner relies on Fumuro for an air port on an inflation
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component with a coupling element rotatably coupled thereto and a tubular
element coupled with the coupling element. Id.
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art at the time of the invention to combine the
teachings of the prior art to achieve the claimed invention. Id. at 5–11.
According to the Examiner, a person of ordinary skill in the art would have
done this to compensate for hydrostatic forces based on the location of a
blood pressure cuff, to adjust a blood pressure measurement based on height
differentials, to protect against fall risk from posture changes, and to provide
a detachable connection for ease of maintenance. Id. Finally, the Examiner
finds that positioning the altitude sensor on the coupling element of the
blood pressure cuff such that a center of the first altitude sensor is at a same
location as the center of the air port in a y-axis direction of the x-y plane of
the inflation component is merely a design choice for the placement of the
sensor in Moon. Id. at 11.
Appellant concedes that Baym discloses an altitude sensing device
that determines the altitude of an inflatable cuff as worn by an individual
during a blood pressure measurement. Appeal Br. 19. Nevertheless,
Appellant argues that the prior art, including Baym, fails to disclose
positioning the first altitude sensor along the y-axis of the x-y plane of the
inflation component. Id. Appellant further argues that such placement is not
merely a matter of “design choice.” Id.
The claimed position of the first sensor is not “mere design
choice”. The claimed position of the first sensor directly
impacts the measurements taken by the system. Specifically,
positioning the first sensor at the center of the air port in a
y-axis direction of the x-y plane of the inflation component (as
shown in Figure 4) provides an accurate measurement of the
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relative height of the inflation component when generating an
adjusted blood pressure measurement. If the first sensor were
positioned differently, this would impact the measurement.
Id. at 19–20.
In response, the Examiner observes that Appellant’s own
Specification fails to indicate or suggest that there is any criticality with
respect to placement of an altitude sensor in a particular location on the cuff.
Ans. 3–4 (citing Spec. ¶¶ 35–36, 41). The Examiner remarks that “it seems
the altitude sensor must merely be on the cuff.” Id. at 4. Specifically with
respect to Appellant’s argument that positioning the sensor differently would
impact the measurement, the Examiner observes that “Appellant only
provides criticality to placement of an altitude sensor at a cuff location.” Id.
at 5.
Appellant’s Specification teaches that adjusted blood pressure
measurements can be used to diagnose orthostatic hypotension. Spec. ¶ 8.
In this regard, Appellant’s device receives first and second height
measurements from each of a first altitude sensor and a second altitude
sensor. Id. ¶ 7. The first and second measurements are recorded at different
patient positions, such as laying down, sitting, and standing. Id. The second
altitude sensor is positioned at the heart level of the patient. Id. at 8.
Figure 3 from Appellant’s disclosure depicts an unrolled example
cuff 202 that includes air port 204 and altitude sensor 102. Spec. ¶ 33,
Fig. 3. Cuff 202 is disposed in an x-y plane that coincides with the plane of
the page on which Figure 3 appears, said figure being annotated with x-y
coordinate arrows. Id. Spec. ¶ 35, Fig. 3.
The example cuff 202 has an x-y-plane that substantially
conforms to one side of the cuff. In embodiments, the
altimeter 102 is positioned on the cuff 202 such that the center
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of the altimeter 102 is at the same as the center of the air
port 204 in the y-axis direction. In some embodiments, the
altimeter 102 is positioned on the cuff 202 such that the center
of the altimeter 102 is aligned with the center of the air port 204
in the x-axis direction. In other embodiments, the center of the
altimeter 102 is positioned on the cuff 202 such that it is not in
alignment in either the x- or y-directions with the center of the
air port 204.
Id. ¶ 35. Stated differently, in various embodiments, the altitude sensor can
be aligned with: (1) the x-axis, (2) the y-axis, or (3) anywhere else on the x-y
plane defined by the cuff. Id.
The y-axis/x-y plane claim language that Appellant now relies on to
distinguish over the prior art was added to claim 1 by amendment. Compare
Claims App. claim 1, with Spec. (as filed) claim 1. Indeed the terms
“y-axis” and “x-y plane” do not appear anywhere in Appellant’s claims as
originally filed. Spec. (as filed) claims 1–20. Furthermore, conspicuously
absent from Appellant’s Specification is any teaching that placing the
altitude sensor along the y-axis results in any difference in operation or
accuracy of the device when compared with placing the altitude sensor along
the x-axis or anywhere else within the x-y plane.
Furthermore, it bears mention that Appellant’s cuff may be worn by
the user on the arm, wrist, finger, thigh, or lower leg. Spec. ¶¶ 30, 33, 41.
Measurements from Appellant’s device may be made at different patient
positions such as laying down, sitting, and standing. Id. ¶ 7. We understand
that the term “altitude” as used with respect to Appellant’s invention relates
to some height measured in a vertical direction above a plane that is parallel
to sea level. Such orientation is fixed in space. The x-y plane of Appellant’s
device, on the other hand, will vary depending on where and how it is worn
by the patient as well as by the posture of the patient and the positioning of
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Application 14/450,510
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the patients’ appendages. In other words, there may be times when the
y-axis of Appellant’s device is more-or-less aligned with the vertical/altitude
dimension and there may be other times when, due to the positioning or
posture of the patient, the x-axis is more-or-less aligned with the
vertical/altitude dimension. There is no teaching or other discussion in
Appellant’s Specification that accounts for the aforementioned variability in
patient positioning relative to the vertical/altitude dimension.
Appellant’s argument against the Examiner’s determination regarding
design choice is unpersuasive. Appellant’s position that positioning of the
first sensor “directly impacts” the measurements taken by the system is not
supported by any evidence or persuasive technical reasoning. Thus,
Appellant’s entire opposition to the Examiner’s determination amounts to
unsubstantiated attorney argument that is entitled to little weight. See In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (explaining that attorney
arguments and conclusory statements that are unsupported by factual
evidence are entitled to little probative value). Where there is an entire
failure on the part of Appellant to present any reason that the difference
between the claimed invention and the prior art results in a different function
or produces unexpected results, it may be appropriate to sustain an
Examiner’s design choice determination. See In re Rice, 341 F.2d 309, 314
(CCPA 1965) (“Appellants have failed to show that the change [in the
claimed invention] as compared to [the reference], result in a difference in
function or give unexpected results.”).
In the instant case, Appellant makes much of the fact that Baym does
not specifically state where the altitude sensor is located relative to the
inflatable cuff. Appeal Br. 19. However, Appellant’s own Specification
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essentially informs the reader that it matters naught whether the sensor is
placed on the x-axis, the y-axis, or anywhere else on the x-y plane. Spec.
¶ 35. Appellant presents neither evidence nor persuasive technical reasoning
that location of the sensor on the cuff is critical to operation of the claimed
device.
The Examiner’s findings of fact are supported by a preponderance of
the evidence and the Examiner’s legal conclusion of unpatentability is well-
founded. In view thereof, we sustain the Examiner’s unpatentability
rejection of claims 1 and 3–6.
Unpatentability of Claims 9–11, 15, and 18
over Moon, Baym, Kato, Kroll, and Evans
Appellant argues claims 9–11, 15, and 18 as a group. Appeal
Br. 21–22. Claim 9 is representative. 37 C.F.R. § 41.37(c)(1)(iv).
Claim 9 is an independent method claim and includes limitations
directed to receiving and analyzing third and fourth height measurements,
respectively, from the first and second altimeters. Claims App. Appellant
argues that the cited art fails to teach or suggest a method. Appeal Br. 21.
In response, the Examiner states:
The references of Moon and Kato teach that a single corrected
blood pressure measurement can be output by the use of two
heights measurements for correction and a blood pressure
measurement. Then Evans and Kroll note that hypotension is
evaluated by changes in blood pressure between postures. So
based on given teachings, one of ordinary skill in the art would
want to create an accurate blood pressure measurement at two
different heights, and one of ordinary skill in the art would
recognize that an accurate blood pressure measurement requires
two altitude values for each of the blood pressure
measurements. Thus, one would be motivated to perform
corrected blood pressure measurements at sitting position
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(using first blood pressure and first heart height and first cuff
height) and then at the standing position (using second pressure
and second heart height and second cuff height).
Ans. 6.
As explicitly found by the Examiner in the Final Rejection, Evans
teaches having a patient change positions from lying down to sitting or
standing to diagnose orthostatic hypotension risk. Final Act. 18 (citing
Evans ¶ 30). Thus, as we understand the Examiner proposed combination,
Moon and Kato teach receiving and analyzing information from a first
height measurement from a first altimeter and a second height measurement
from a second altimeter. Evans and Kroll evaluate hypotension by
comparing changes in blood pressure from a laying down or sitting position
to a standing position. Combining the teachings of the prior art would
satisfy the claim limitations at issue. In other words, the device of
Moon/Kato would first take blood pressure measurements at first and second
altitude sensors when the patient is in a laying down or sitting position and,
then, in accordance with the teachings of Evans and Kroll, the Mood/Kato
device would take two more measurements, one from each sensor, after the
patient assumes a standing position. Appellant’s argument in traverse of the
rejection is abbreviated and conclusory, comprising a single, six-line
paragraph. Appeal Br. 21. There is no detailed analysis or discussion that
tends to undermine or rebut the Examiner reasoning. Id. Having considered
the competing positions of Appellant and the Examiner, we find the
Examiner’s position more persuasive.
We sustain the Examiner’s rejection of claims 9–11, 15, and 18.
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Unpatentability of Claims 7, 12, 14, 16, 17, 21, and 22
over Combinations base on Moon, Baym, Kato, and Kroll
These claims depend, directly or indirectly, from either of
independent claims 1 or 9. Claims App. Appellant does not argue for their
separate patentability apart from arguments presented with respect to
claims 1 and 9, which we have previously considered. Consequently, for
reasons previously expressed with respect to claims 1 and 9, we sustain the
Examiner’s rejection of claims 7, 12, 14, 16, 17, 21, and 22.
CONCLUSION
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3-6 103 Moon, Baym, Kato,
Kroll, Fumuro
1, 3-6
7 103 Moon, Baym, Kato,
Kroll, Fumuro, Banet
7
9–11, 15,
18
103 Moon, Baym, Kato,
Kroll, Evans
9–11, 15,
18

12 103 Moon, Baym, Kato,
Kroll, Evans, Fumuro,
Bridger
12
14 103 Moon, Baym, Kato,
Kroll, Evans, Fumuro,
Banet
14
16, 17 103 Moon, Baym, Kato,
Kroll, Evans, Fumuro,
Tenzer
16, 17
21, 22 103 Moon, Baym, Kato,
Kroll, Fumuro, Kiani
21, 22
Overall
Outcome
1, 3-7, 9-
12, 14-18,
21, 22

Appeal 2020-004536
Application 14/450,510
12
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED