J&M SHULER, INC.

Patent Trials and Appeals Board

Sep 1, 2020

2020000658 (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.
15/088,242 04/01/2016 MICHAEL SIMMS SHULER 19081.0001U9
LEGSARMS SPW
2075
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 2020-000658
Application 15/088,242
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 21, 28, 34–36, and 38–52. 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.
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CLAIMED SUBJECT MATTER
Of the claims on appeal, claims 21 and 28 are independent. Claim 21
is directed to a method for monitoring oxygenation levels of compartments
of tissue in the human body that may be suffering ischemia, while claim 28
is directed to a system for doing the same. Claim 21, reproduced below, is
illustrative.
21. A method for automatically detecting ischemia in a
human body with a computing device, comprising:
automatically monitoring oxygenation levels of damaged
tissue of the human body in a continuous manner with the
computing device coupled to a non-invasive compartment
sensor, wherein the damaged tissue comprises a compartment of
the human body;
automatically monitoring oxygenation levels of healthy
tissue of the human body with the computing device coupled to
a non-invasive healthy tissue sensor in a continuous manner, the
non-invasive healthy tissue sensor detecting systemic perfusion
of the human body from the healthy tissue;
automatically calculating a difference between the
oxygenation levels from the non-invasive 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; and
activating an alarm module with the computing device
indicating a potential acute compartment syndrome when
oxygenation levels of the non-invasive compartment sensor start
decreasing in value compared to the oxygenation levels of the
non-invasive healthy tissue sensor for the healthy tissue.
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EVIDENCE OF RECORD
Name Reference Date
Chance US 5,873,821 Feb. 23, 1999
Mendelson US 6,801,799 B2 Oct. 5, 2004
Shehada US 2004/0254432 A1 Dec. 16, 2004
Huiku US 2005/0250998 A1 Nov. 10, 2005
Lane US 2009/0275805 A1 Nov. 5, 2009
Li US 2010/0145169 A1 June 10, 2010

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
21, 28, 40, 41, 47, 49, 50 103(a) Li, Chance
34, 35, 38, 44, 45 103(a) Li, Chance, Lane
36, 46 103(a) Li, Chance, Mendelson
39, 48 103(a) Li, Chance, Huiku
42, 43, 51, 52 103(a) Li, Chance, Shehada

ANALYSIS
A. Independent Claims 21 and 28
Appellant argues independent claims 21 and 28 separately, but
advances the same arguments with respect to both claims. In particular,
Appellant argues that claims 21 and 28 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 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.
Appeal Br. 12–13 (claim 21); see also id. at 39–40 (arguing that the
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Li/Chance combination fails to teach essentially the same limitations in
claim 28). 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 21. 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 compartment sensor and an
oxygenation level for a healthy tissue sensor that are both
displayed proximate to the difference.

Id. at 18. Appellant further argues that Chance “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 damaged
tissue [because] . . . [t]he Chance reference never mentions by name any
form of compartment syndrome.” Id. at 19, 24, respectively.
We disagree. 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.
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).”
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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.
p. 21, ll. 5–8, p. 22, ll. 5–26.
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 damaged tissue, the Examiner acknowledges that Li does not
expressly teach a second non-invasive sensor to derive the threshold (i.e.,
baseline) oxygenation value of healthy tissue. See Exr. Ans. 4–5. For that
aspect of the claimed invention, the Examiner points to Chance’s teaching of
“a non-invasive healthy tissue sensor for monitoring oxygenation levels of
healthy tissue, or as a reference/healthy 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
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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
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
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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 damaged 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 damaged 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
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

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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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 damaged 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
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
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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. 17–18 (emphasis omitted). We note,
however, that claims 21 and 28 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. 8. 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 21 and 28. 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. 18. Nonetheless, Chance teaches a “display module” for
monitoring the oxygenation levels measured by both a healthy tissue sensor
and a damaged 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
syndrome). Given that both Li and Chance teach the display of measured
oxygenation levels to assist in monitoring and treating damaged 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
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not only the oxygenation level of the damaged 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 damaged tissue. Accordingly, we find
unpersuasive Appellant’s evidence of non-obviousness.
Having considered Appellant’s arguments and the prior art of record,
we sustain the Examiner’s rejection of independent claims 21 and 28 as
unpatentable over the combined teachings of Li and Chance.
B. Dependent Claims 34–36 and 38–52
To refute the rejection of dependent claims 34–36 and 38–52,
Appellant relies on the arguments it presented for patentability of claims 21
and 28, and argues that the additional prior art (Lane, Mendelson, Huiku,
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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 21 and 28, we do not find these arguments
persuasive. Accordingly, we sustain the Examiner’s rejection of dependent
claims 34–36 and 38–52.
CONCLUSION
The Examiner’s rejections are AFFIRMED.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
21, 28, 40,
41, 47, 49, 50
103(a) Li, Chance 21, 28, 40,
41, 47, 49, 50

34, 35, 38,
44, 45
103(a) Li, Chance,
Lane
34, 35, 38,
44, 45

36, 46 103(a) Li, Chance,
Mendelson
36, 46
39, 48 103(a) Li, Chance,
Huiku
39, 48
42, 43, 51, 52 103(a) Li, Chance,
Shehada
42, 43, 51, 52
Overall
Outcome
21, 28, 34–
36, 38–52

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