J&M SHULER, INC.

Patent Trials and Appeals Board

Sep 1, 2020

2020000675 (P.T.A.B. Sep. 1, 2020)

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.
15/088,220 04/01/2016 MICHAEL SIMMS SHULER 19081.0001U8
LEGSCON SPW
6227
35856 7590 09/01/2020
SMITH TEMPEL BLAHA LLC
Docketing Department
50 Glenlake Parkway
Suite 340
Atlanta, GA 30328
EXAMINER
WEARE, MEREDITH H
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
09/01/2020 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):
docket@srtslaw.com
gsmith@srtslaw.com
mtempel@srtslaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL SIMMS SHULER
Appeal 2020-000675
Application 15/088,220
Technology Center 3700
Before CARL M. DEFRANCO, GEORGE R. HOSKINS, and
LISA M. GUIJT, Administrative Patent Judges.
DEFRANCO, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 5, 9, 11, 13, 17, 19–22, and 25–30. 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 the real party in interest as J&M
Shuler, Inc. Appeal Br. 2.

Appeal 2020-000675
Application 15/088,220

2
CLAIMED SUBJECT MATTER
Of the claims on appeal, claims 5 and 13 are independent. Claim 5 is
directed to a method for automatically monitoring oxygenation levels of
injured tissue in the human body in order to detect conditions of an acute
compartment syndrome (“CS”), while claim 13 is directed to a system for
doing the same. Claim 5 is illustrative and reproduced below.
5. A computer-implemented method for automatically
monitoring oxygenation levels of injured tissue of a human body
for automatically detecting conditions of an acute compartment
syndrome, comprising:
automatically monitoring oxygenation levels of injured
tissue in a continuous manner with a first non-invasive sensor;
automatically monitoring oxygenation levels of healthy
tissue in a continuous manner with a second non-invasive sensor,
the second non-invasive sensor detecting systemic perfusion of
the human body from the healthy tissue;
automatically calculating a difference between the
oxygenation levels from the first non-invasive sensor relative to
the non-invasive second sensor and displaying this difference on
a display device proximate to the oxygenation levels of the first
non-invasive sensor and second non-invasive sensor also being
displayed on the display device; and
automatically activating an alarm with a computing device
indicating a potential acute compartment syndrome when
oxygenation levels of the first non-invasive sensor for the injured
tissue start decreasing in value compared to the oxygenation
levels of the second non-invasive sensor for the healthy tissue,
the second non-invasive sensor providing a basis for comparison
for relative oxygenation levels of the injured tissue.
Appeal 2020-000675
Application 15/088,220

3
EVIDENCE OF RECORD
Name Reference Date
Chance US 5,873,821 Feb. 23, 1999
Friedman US 6,050,951 Apr. 18, 2000
Ortner  US 7,596,397 B2  Sep. 29, 2009 
Shehada US 2004/0254432 A1 Dec. 16, 2004
Baker US 2008/0146906 A1 June 19, 2008
Li US 2010/0145169 A1 June 10, 2010
Tsien Reducing False Alarms in the
Intensive Care Unit: A Systematic
Comparison of Four Algorithms
1997

EXAMINER’S REJECTIONS
Appellant appeals from the Examiner’s Final Office Action, dated
November 15, 2018, which includes the following rejections:
Claims Rejected 35 U.S.C. § Basis
5, 11, 13, 22, 25, 28 103(a) Li, Chance
9 103(a) Li, Chance, Ortner
17 103(a) Li, Chance, Friedman
19, 20 103(a) Li, Chance, Baker
21 103(a) Li, Chance, Tsien
26, 27, 29, 30 103(a) Li, Chance, Shehada

ANALYSIS
A. Independent Claims 5 and 13
Appellant argues independent claims 5 and 13 separately, but
advances the same arguments with respect to both claims. See Appeal Br.
39 (remarking that Appellant’s arguments for claim 13 are “[s]imilar to the
arguments presented above for independent Claim 5”). In particular,
Appellant argues that claims 5 and 13 are allowable because the combination
of Li and Chance fails to teach the claim limitations of calculating a
difference between the oxygenation levels from the non-invasive
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4
compartment sensor relative to the non-invasive healthy tissue sensor and
displaying this difference on a display device proximate to the oxygenation
levels of the non-invasive compartment sensor and the non-invasive healthy
tissue sensor also being displayed on the display device. Id. at 13 (claim 5);
see also id. at 39–40 (arguing that combination of Li and Chance fails to
teach essentially the same limitations in claim 13). According to Appellant,
[t]here is no difference between oxygenation levels of a first
sensor and a second sensor being calculated by the Li reference
whatsoever. The Li reference never teaches or suggests
displaying sensor data for individual sensors as recited in
Claim 5. Furthermore, there is no display of such a difference
being taught or suggested by the Li reference NOR is there a
display of an oxygenation level for a first sensor and an
oxygenation level for a second sensor that are both displayed
proximate to the difference.

Id. at 18. As for Chance, Appellant argues that it “relates to a differential
spectrophotometer system, which is not related to any compartment
syndrome (exertional or acute compartment syndrome) whatsoever” and,
thus, “a person skilled in the art would not look at the Chance reference for
any teachings about acute compartment syndrome that involves injured
tissue [because] . . . [t]he Chance reference never mentions by name any
form of compartment syndrome.” Id. at 19, 24, respectively.
We do not find Appellant’s arguments persuasive. As discussed
below, the evidence supports the Examiner’s findings that the combination
of Li and Chance teaches the recited limitations and that a skilled artisan
would have been led to combine their respective teachings to arrive at the
claimed invention. See Exr. Ans. 3–8.
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5
1. The Monitoring and Calculating Limitations
In satisfying the claimed “monitoring” and “calculating” steps, Li
teaches a method and system of using a “non-invasive sensor,” such as a
“near infrared spectrometry (NIRS) sensor,” to measure “deoxygenated
hemoglobin” and “[o]xygenated [h]emoglobin” levels in human tissue “for
detecting and alerting one to a condition of Compartment Syndrome (CS).”
Li ¶¶ 2, 9, 14, 17, 30, Claims 1, 11, 19, Fig. 2. This is no different than how
Appellant’s specification describes the claimed invention, which likewise
uses “near-infrared spectroscopy (NIRS) sensors 405A, 405B” to measure
“hemoglobin oxygen concentration . . . for the accurate detection of
conditions that may be associated with compartment syndrome.” See Spec.
¶¶ 89, 94–95, Fig. 4.
Also, like the claimed invention, Li compares the measured
oxygenation levels with a presumed healthy tissue threshold value and
activates an alarm when the difference between the oxygenation levels
indicates a condition of compartment syndrome. Li ¶¶ 34–41. More
specifically, Li states that—
the difference between the concentration of HbO2 and an initial
concentration of HbO2 is compared with a threshold value which
corresponds to a value indicating a condition of CS. If the
difference is less than the threshold value, then a corresponding
alarm is triggered at block 222.

Id. ¶ 40.
As for the claim limitation directed to a healthy tissue sensor for
deriving oxygenation levels as a basis for comparison with oxygenation
levels of injured tissue, the Examiner acknowledges that Li does not
expressly teach a second non-invasive sensor to derive the threshold (i.e.,
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6
baseline) oxygenation value of healthy tissue. See Exr. Ans. 4–5. For that
aspect of the claimed invention, the Examiner points to Chance as teaching
“a second non-invasive sensor for monitoring oxygenation levels of healthy
tissue, or as a reference oxygenation level.” Id. at 5.
We agree with the Examiner’s findings in this regard. For instance,
Chance teaches a “non-invasive” system that uses “tissue spectrometry” to
measure and monitor “the oxygenation state of a specific area of tissue,” be
it muscle tissue or brain tissue. Chance, 1:5–11, 1:62–2:16. In one preferred
embodiment, Chance’s spectrophotometer uses “two sensor modules” for
detecting changes in electromagnetic radiation between “two localized
tissues of interest.” Id. at 26:1–36, Fig. 24. According to Chance, the
localized tissues of interest may be “regions of the left and right hemisphere
of the brain, left and right breast, or left and right arm.” Id. at 26:15–17.
Notably, Chance’s first sensor collects reference data from localized tissue
that is expected to have normal (i.e., healthy) physiological properties, while
Chance’s second sensor collects data from localized tissue that is expected to
have abnormal (i.e., pathological or pathophysiological) changes, such as
from a tumor or bleeding. Id. at 26:5–10. The tissue is then evaluated by
“comparing” signals from the sensors to detect any pathophysiological
changes, which Chance identifies as including “oxygenation/deoxygenation
changes.” Id. at 26:48–27:6; see also id. at 29:16–18 (“said
pathophysiological change includes . . . hemoglobin oxygenation change of
the examined tissue”). Because oxygenation levels should be substantially
the same in the absence of an abnormal condition, a significant change in the
oxygenation level of the injured tissue as compared to that of the healthy
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tissue is indicative of an abnormal condition. See id. at 26:10–23, 26:48–
27:15.
Appellant raises essentially two arguments in response to the
Examiner’s combination of Li with Chance. First, Appellant argues that
Chance “is not related to any compartment syndrome (exertional or acute
compartment syndrome) whatsoever.”2 Appeal Br. 19; see also id. at 24
(“The Chance reference never mentions by name any form of compartment
syndrome.”). Although Appellant is correct that Chance does not expressly
teach that the abnormal condition may be acute CS, we agree with the
Examiner’s finding that Li resolves this shortcoming by teaching that, in the
presence of acute CS, the oxygenation levels of injured tissue (i.e., tissue
where acute CS may develop) decrease with elevated compartment pressure
relative to a threshold oxygenation level. See Exr. Ans. 7 (citing Li ¶ 40).
In other words, Li’s use of a threshold oxygenation level corresponds to
Chance’s use of a healthy tissue oxygenation level in that each is used as a
basis for comparison with the oxygenation level of injured tissue in order to
detect an abnormal condition.
Appellant further argues that Chance “do[es] not provide any teaching
of measuring oxygenation levels.” Appeal Br. 25 (emphasis omitted); see
also id. at 29 (arguing “the Chance reference in no way describes
oxygenation levels”). We disagree. Chance states expressly that the “object
of the present invention” is “to provide methods and apparatus which allow

2 Appellant also discusses Figures 2 and 3 of Chance in an attempt to
distinguish Chance from the claimed invention. Appeal Br. 19–24. We do
not see the relevancy of this discussion given that the Examiner relies on
Chance’s Figure 24, not Figures 2 and 3. See Exr. Ans. 6–7.
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a rapid determination of the oxygenation state of tissue.” Chance, 2:65–67;
see also id. at 3:5–9 (“It is also an object of the present invention to provide
apparatus which may be attached to a user which would determine the
oxygenation state of a portion of the user’s body and provide that
information in a readily understandable form.”). And, with respect to
Figure 24, Chance likewise states that the pathophysiological changes
detected by the two sensors include “oxygenation/deoxygenation changes.”
Id. at 27:5–6; see also id. at 29:16–18 (“said pathophysiological change
includes blood volume change or hemoglobin oxygenation change of the
examined tissue”). Thus, we reject the notion that Chance fails to teach that
the disclosed sensors measure oxygenation levels.
In sum, we agree with the Examiner that Chance suggests a suitable,
predictable alternative for deriving Li’s threshold or baseline value, namely,
using a second sensor to measure oxygenation levels of comparable tissue
known to be healthy. Thus, consistent with the Examiner’s rejection, the
record supports that a skilled artisan would have been led to modify Li’s CS
detection system to incorporate a healthy tissue sensor, as taught by Chance,
for deriving Li’s threshold value as a basis for comparison with the
measured oxygenation levels of Li’s injured tissue sensor to identify the
point at which oxygenation levels begin to differ significantly.
2. The Displaying Limitation
Appellant does not dispute that both Li and Chance teach displaying
the measured oxygenation levels of the tissue being monitored. For
instance, Appellant admits that Li discloses displaying a “plot” of
oxygenation data measured from injured tissue over time, as well as “trends”
in the measured data. Appeal Br. 18. Nor does Appellant dispute Li’s
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disclosure of displaying “the difference” (or change) between measured
oxygenation levels and initial oxygenation levels relative to a threshold
value indicative of a CS condition. See Li ¶¶ 38–42 (“The concentration
values are analysed at block 208 to detect a condition of CS . . . The
concentration values and results of the analysis at block 208 may be
displayed on a display, as shown at block 230.”); see also id. ¶¶ 66–69
(describing the information displayed).
Instead, Appellant merely disputes the “relative placement” of Li’s
data “on the display.” Appeal Br. 18 (emphasis omitted). We note,
however, that claims 5 and 13 only require that the calculated “difference”
value be displayed “proximate to” (i.e., close to, or nearby) the measured
oxygenation levels, not “[u]nderneath” them as Appellant seemingly argues.
Appeal Br. 11. Because Li discloses that both the plot of measured
oxygenation values and the resulting analysis of differences between
measured and threshold oxygenation levels are shown on the same display,
we agree with the Examiner’s finding that Li’s display meets the “proximate
to” limitation of the displaying step of claims 5 and 13. See Exr. Ans. 5.
That said, however, we agree with Appellant that Li does not teach or
suggest displaying oxygenation data from a healthy tissue sensor. See
Appeal Br. 17–18. Nonetheless, Chance teaches a “display module” for
monitoring the oxygenation levels measured by both a healthy tissue sensor
and an injured tissue sensor. Chance, 26:24–28, 26:48–52. According to
Chance, the display may be “a digital display, a bar graph or a series of
deoxyhemoglobin levels, placed on a time scale.” Id. at 2:55–61. Nowhere
does Appellant dispute those teachings by Chance. See Appeal Br. 19–29
(arguing only that Chance is not directed to the detection of compartment
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10
syndrome). Given that both Li and Chance teach the display of measured
oxygenation levels to assist in monitoring and treating injured tissue, we
agree with the Examiner that a skilled artisan, upon modifying Li’s system
to incorporate Chance’s healthy tissue sensor for determining Li’s threshold
oxygenation value, also would have been led to modify Li’s display to show
not only the oxygenation level of the injured tissue sensor but also the
oxygenation level of the baseline sensor taught by Chance, in order to permit
visualization of the healthy tissue oxygenation levels relative to the injured
tissue oxygenation levels for purposes of detecting an abnormal CS
condition. See Exr. Ans. 4–5.
Finally, we have considered Appellant’s evidence of non-obviousness
consisting of two peer review articles purporting to show skepticism of
experts. See Appeal Br. 29–38. We do not find this evidence persuasive.
Rather, we agree with the Examiner’s reasoning that, although the two peer
review articles “suggest that using a single NIRS sensor or spectrometer to
monitor oxygenation levels of injured tissue is not sufficient to detect acute
CS,” neither of them appears skeptical of using a second reference sensor as
the indicator of healthy oxygenation levels and the basis for comparison to
those of injured tissue. Exr. Ans. 8. Indeed, from our review of the two peer
review articles, they actually support Chance’s teaching that a skilled artisan
would have been led to provide a second sensor of known healthy
oxygenation levels as a baseline for comparison to the NIRS sensor
monitoring oxygenation levels of injured tissue. Accordingly, we find
unpersuasive Appellant’s evidence of non-obviousness.
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Having considered Appellant’s arguments and the prior art of record,
we sustain the Examiner’s rejection of independent claims 5 and 13 as
unpatentable over the combined teachings of Li and Chance.
B. Dependent Claims 9, 11, 17, 19–22, and 25–30
To refute the rejection of dependent claims 9, 11, 17, 19–22, and 25–
30, Appellant relies on the arguments it presented for patentability of claims
5 and 13, and argues that the additional prior art (Ortner, Tsien, Friedman,
Baker, and Shehada) used to reject these claims does not cure the
deficiencies of Li and Chance. Appeal Br. 40. For the same reasons
provided above in our analysis of the rejection of claims 5 and 13, we do not
find these arguments persuasive. Accordingly, we sustain the Examiner’s
rejection of dependent claims 9, 11, 17, 19–22, and 25–30.
CONCLUSION
The Examiner’s rejections are AFFIRMED.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
5, 11, 13,
22, 25, 28
103(a) Li, Chance 5, 11, 13,
22, 25, 28

9 103(a) Li, Chance, Ortner 9
17 103(a) Li, Chance,
Friedman
17
19, 20 103(a) Li, Chance, Baker 19, 20
21 103(a) Li, Chance, Tsien 21
26, 27, 29,
30
103(a) Li, Chance, Shehada 26, 27, 29,
30

Overall
Outcome
5, 9, 11,
13, 17,
19–22,
25–30

Appeal 2020-000675
Application 15/088,220

12
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED