Masimo Corporation

Patent Trials and Appeals Board

Nov 19, 2021

IPR2020-00967 (P.T.A.B. Nov. 19, 2021)

Trials@uspto.gov Paper 43
571-272-7822 Date: November 19, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

SOTERA WIRELESS, INC.,
Petitioner,
v.
MASIMO CORPORATION,
Patent Owner.

IPR2020-00967
Patent RE47,244 E

Before JOSIAH C. COCKS, JENNIFER MEYER CHAGNON, and
AMANDA F. WIEKER, Administrative Patent Judges.
CHAGNON, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)
Dismissing Petitioner’s Motion to Exclude
37 C.F.R. § 42.64

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I. INTRODUCTION
A. Background
Sotera Wireless, Inc. (“Petitioner”)1 filed a Petition requesting inter
partes review of claims 1–26 (“the challenged claims”) of U.S. Patent
No. RE47,244 E (Ex. 1001, “the RE244 patent”). Paper 1 (“Pet.”). Masimo
Corporation (“Patent Owner”) filed a Preliminary Response. Paper 7. We
instituted an inter partes review of all challenged claims 1–26 on all grounds
of unpatentability, pursuant to 35 U.S.C. § 314. Paper 13 (“Inst. Dec.”).2
After institution, Patent Owner filed a Response (Paper 24,
“PO Resp.”) to the Petition, Petitioner filed a Reply (Paper 28, “Pet.
Reply”), and Patent Owner filed a Sur-reply (Paper 32, “PO Sur-reply”).
Additionally, Petitioner filed a Motion to Exclude certain deposition
testimony (Paper 37, “MTE”), Patent Owner filed an Opposition (Paper 38),
and Petitioner filed a Reply (Paper 39). An oral hearing was held on
September 8, 2021, and a transcript of the hearing is included in the record.
Paper 42 (“Tr.”).
We issue this Final Written Decision pursuant to 35 U.S.C. § 318(a)
and 37 C.F.R. § 42.73. For the reasons set forth below, Petitioner has met
its burden of showing, by a preponderance of the evidence, that challenged
claims 1–26 of the RE244 patent are unpatentable.

1 Petitioner identifies Sotera Wireless, Inc. and Hon Hai Precision Industry
Co., Ltd. (“Hon Hai”) as real parties-in-interest to this proceeding. Pet. 1.
Petitioner states that Hon Hai is named as a real party-in-interest due to its
involvement in a related proceeding. Id.
2 To address institution considerations under 35 U.S.C. § 314(a), and with
our authorization, Petitioner filed a Preliminary Reply (Paper 11) and Patent
Owner filed a Preliminary Sur-reply (Paper 12). We do not refer to either
paper in this Final Written Decision.
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B. Related Proceedings
The parties identify Masimo Corp. v. Sotera Wireless, Inc., Case
No. 3:19-cv-01100-BAS-NLS (S.D. Cal.) as a related matter involving the
RE244 patent. Pet. 2; Paper 5, 1.
Patent Owner identifies the following inter partes review proceedings,
involving patents related to the RE244 patent and which are asserted in the
related district court matter:
IPR2020-00912, challenging U.S. Patent No. 10,213,108 B2;
IPR2020-00954, challenging U.S. Patent No. 9,788,735 B2;
IPR2020-01015, challenging U.S. Patent No. 9,795,300 B2;
IPR2020-01019, challenging U.S. Patent No. RE47,353 E;
IPR2020-01033, challenging U.S. Patent No. RE47,249 E;
IPR2020-01054, challenging U.S. Patent No. 9,872,623 B2;
IPR2020-01078, challenging U.S. Patent No. RE47,218 E; and
IPR2020-01082, challenging U.S. Patent No. 10,255,994 (institution
denied).
Paper 6, 2.
Patent Owner further identifies various applications that claim priority
to, or share a priority claim with, the RE244 patent. Id. at 1.
C. The RE244 Patent
The RE244 patent, titled “Alarm Suspend System,” was filed May 1,
2017, and issued on February 19, 2019. Ex. 1001, codes (22), (45), (54).
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The RE244 patent was filed as a reissue application of U.S. Patent No.
9,153,121. Id. at code (64).3
The RE244 patent describes a physiological measurement system that
utilizes an alarm suspend system. Id. at 4:25–26. The disclosed system
includes physiological monitor 101 and noninvasive sensor 105, which
measures, e.g., pulse oximetry parameters, carboxyhemoglobin,
methemoglobin, and/or total hemoglobin. Id. at 4:25–36, Fig. 1. The
monitor may include a display, touch keys, and controls including “an alarm
silence button [] that is pressed to temporarily suspend out-of-limit
parameter alarms and system alarms, such as low battery.” Id. at 4:37–48.
The alarm suspend system both prevents unnecessary disturbances to
patients and distractions to caregivers. Id. at 2:33–36. “Advantageously, an
alarm suspend system provides a parameter-dependent variation in the alarm
suspend duration, as described below, utilizing a common silence button or
other suspend initiator.” Id. at 4:60–63. “The alarm suspend period is
typically long enough to give a caregiver sufficient time to intervene with
appropriate patient treatment yet short enough to ensure that patient health is
not endangered if intervention is ineffective.” Id. at 2:38–42.

3 The RE244 patent claims earliest priority through a series of continuation
applications to Provisional application No. 61/084,615, filed on July 29,
2008. Ex. 1001, codes (60), (63). The specific priority date of the
challenged claims is not at issue in this proceeding, and we need not make
any determination in this regard for purposes of this Decision.
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Figure 3 of the RE244 patent, reproduced below, illustrates a flow
diagram of an alarm suspend system. Id. at 4:16–17.

As shown in Figure 3, above, “[a]larm triggers include system failures 338
and out-of-limit parameters 318.” Id. at 5:43–44. Out-of-limit parameters
are identified by comparing measured parameters 312 to default or
user-specified limits 314. Id. at 5:51–52. Out-of-limit condition 318
triggers alarm 340 that can be suspended 328 by user-initiated silence
request 322. Id. at 5:52–56. Suspend durations may vary depending on the
parameter. Id. at 6:23–28. For example, “relatively slow treatment
parameters, such as [methemoglobin (‘HbMet’)], [carboxyhemo-
globin (‘HbCO’)], [total haemoglobin (‘Hbt’) and [Pleth Variability Index
(‘PVi’)], are assigned relatively long suspend durations. Similarly,
relatively fast treatment parameters, such as [oxygen saturation (‘SpO2’)]
and [pulse rate (‘PR’)], are assigned relatively short suspend durations.” Id.
at 6:28–33.
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Figure 4, reproduced below, illustrates an alarm suspend “that
operates independently for each measured parameter that can trigger an
alarm.” Id. at 5:66–6:1.

As shown in Figure 4, above, the alarm is initially off 410, and remains off
so long as the measured parameter is within its set limits 412. Id. at 6:1–3.
When a measured parameter becomes outside its set limit 414 (i.e., it is “out-
of-limit”), the system triggers alarm 420. Id. at 6:1–4. A user may activate
silence request 422 that suspends alarm 430, for example, by pressing the
alarm silence button, which then suspends 430 the alarm for predetermined
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duration 432. Id. at 6:5–10. The predetermined duration “may be a function
of the out-of-limit parameter.” Id. at 5:60–61. When the predetermined
duration expires, the alarm is activated until the triggering parameter is
within limit 424 or the user again silences 422 the alarm. Id. at 6:10–14.
“[A]larm suspend 430 deactivates if the measured parameter becomes within
limits 438, such as when the patient condition improves, or if no
physiological data is detected 439.” Id. at 6:14–17. Alternatively, alarm
suspend override 436 reactivates alarm 420 when a measured parameter
changes by a sufficient out-of-limit amount. Id. at 6:19–22.
D. Illustrative Claim
Of the challenged claims, claims 1, 13, and 18 are independent.
Claims 2–12 and 23–26 depend from claim 1; claims 14–17 depend from
claim 13; and claims 19–22 depend from claim 18. Independent claim 1 of
the RE244 patent is reproduced below, and is illustrative of the challenged
claims.4
1. A physiological measurement system comprising:
a noninvasive physiological sensor configured to be positioned
on a patient and output a signal responsive to a physiological
condition of the patient; and
one or more processors in communication with the noninvasive
physiological sensor, the one or more processors configured to
electronically:
process the signal;

4 The RE244 patent is a reissue patent. As is standard when printing the
claims of a reissue patent, matter enclosed in heavy brackets [ ] was deleted
from the original claims and matter printed in italics was added in the
reissued claims. For convenience, we produce a clean version of reissued
claim 1.
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responsive to processing the signal, determine a
measurement of a physiological parameter based at least
in part upon the signal;
determine that the measurement of the physiological
parameter satisfies an alarm activation threshold;
initiate a parameter-specific alarm delay or suspension
period of time corresponding to the physiological
parameter, the parameter-specific alarm delay or
suspension period of time being one of a plurality of
parameter-specific alarm delay or suspension periods of
time, the parameter-specific alarm delay or suspension
period of time being different from at least one other
parameter-specific alarm delay or suspension period of
time corresponding to at least one other physiological
parameter for which the one or more processors are
configured to determine at least one measurement; and
activate an alarm for the physiological parameter in
response to expiration of an amount of delay or suspension
associated with the parameter-specific alarm delay or
suspension period of time.
Ex. 1001, 7:39–8:12.
E. Applied References and Evidence
Petitioner relies on the following references in the asserted grounds.
Pet. 5–8.
Reference Issue Date/ Publication Date Exhibit
U.S. Patent No. 5,865,736 (“Baker-1”) Feb. 2, 1999 Ex. 1005
U.S. Publication No. 2009/0247851 A1
(“Batchelder”) Oct. 1, 2009 Ex. 1006
U.S. Patent No. 8,792,949 B2 (“Baker-2”) Jul. 29, 2014 Ex. 1007
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Reference Issue Date/ Publication Date Exhibit
U.S. Publication No. 2005/0038332 A1
(“Saidara”) Feb. 17, 2005 Ex. 1008
U.S. Publication No. 2003/0135087 A1
(“Hickle”) Jul. 17, 2003 Ex. 1009
S. Malangi, Simulation and mathematical
notation of alarms unit for computer
assisted resuscitation algorithm, New
Jersey Institute of Technology, Theses
526, (2003) (“Malangi”)
Jul. 12, 2004 Ex. 1010
Petitioner also submits the Declaration of George E. Yanulis, EngD
(Ex. 1003) and the Declaration of Bryan Bergeron, MD (Ex. 1040). Patent
Owner submits the Declaration of Jack Goldberg (Ex. 2011).
The parties also rely upon deposition testimony of Dr. Yanulis
(Ex. 2017 (Feb. 4, 2021, deposition); Ex. 2018 (Feb. 5, 2021, deposition);
see also Exs. 2025–2026 (errata)), Dr. Bergeron (Ex. 2022 (June 24, 2021,
deposition)), and Mr. Goldberg (Ex. 1042 (April 13, 2021, deposition);
Ex. 1043 (April 14, 2021, deposition)).
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F. Asserted Grounds of Unpatentability
We instituted an inter partes review based on the following grounds.
Inst. Dec. 10–11, 51.
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1, 6–8, 13, 14, 18, 19, 23–26 1035 Baker-1
1, 2, 6–9, 13–16, 18–26 103 Baker-1, Batchelder
1, 2, 6–9, 13–15, 18–26 103 Baker-1, Batchelder, Baker-2
3–5, 10–12, 16, 17 103 Baker-1, Batchelder, Baker-2, Hickle
1, 2, 6–9, 13–15, 18–26 103 Saidara, Malangi
3–5, 10–12, 16, 17, 26 103 Saidara, Malangi, Hickle
II. ANALYSIS
A. Legal Standards
To prevail in its challenges to the patentability of the claims,
Petitioner must demonstrate by a preponderance of the evidence that the
challenged claims are unpatentable. 35 U.S.C. § 316(e). “In an [inter partes
review], the petitioner has the burden from the onset to show with
particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C.
§ 312(a)(3) (requiring inter partes review petitions to identify “with
particularity . . . the evidence that supports the grounds for the challenge to

5 Because the application leading to the RE244 patent has an effective filing
date before March 16, 2013, patentability is governed by the version of
35 U.S.C. §§ 102 and 103 preceding the Leahy-Smith America Invents Act
(“AIA”), Pub L. No. 112-29, 125 Stat. 284 (2011).
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each claim”)). This burden of persuasion never shifts to Patent Owner. See
Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
(Fed. Cir. 2015) (discussing the burden of proof in inter partes review).
A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) any differences between the claimed subject matter and the prior art;
(3) the level of ordinary skill in the art; and (4) objective evidence of
nonobviousness.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
Consideration of the Graham factors “helps inform the ultimate obviousness
determination.” Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048
(Fed. Cir. 2016) (en banc).
An obviousness analysis “need not seek out precise teachings directed
to the specific subject matter of the challenged claim, for a court can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” KSR, 550 U.S. at 418; accord In re Translogic
Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). However, Petitioner
cannot satisfy its burden of proving obviousness by employing “mere
conclusory statements,” but “must instead articulate specific reasoning,
based on evidence of record” to support an obviousness determination. In re
Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380–81 (Fed. Cir. 2016).

6 Patent Owner has not presented objective evidence of non-obviousness.
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Petitioner also must articulate a reason why a person of ordinary skill in the
art would have combined the prior art references. In re NuVasive, 842 F.3d
1376, 1382 (Fed. Cir. 2016).
At this final stage, we determine whether a preponderance of the
evidence of record shows that the challenged claims would have been
rendered obvious in view of the asserted prior art. We analyze the asserted
grounds of unpatentability in accordance with these principles.
B. Level of Ordinary Skill in the Art
We review the grounds of unpatentability in view of the
understanding of a person of ordinary skill in the art at the time of the
invention. Graham, 383 U.S. at 17. Petitioner contends that a person
having ordinary skill in the art “would have been a person with at least a
B.S. degree in electrical or biomedical engineering or a related field with at
least two years’ experience designing patient monitoring systems,” wherein
“[l]ess work experience may be compensated by a higher level of education,
and vice versa.” Pet. 13 (citing Ex. 1003 ¶¶ 33–41); see Ex. 1040 ¶ 28.
Patent Owner applies the level of ordinary skill in the art identified by
Petitioner. PO Resp. 8 n.5 (citing Ex. 2011 ¶¶ 18–19).
We adopt Petitioner’s assessment, which appears consistent with the
level of skill reflected in the Specification and prior art.
C. Claim Construction
For this inter partes review proceeding, claim terms
shall be construed using the same claim construction
standard that would be used to construe the claim in a civil action
under 35 U.S.C. [§] 282(b), including construing the claim in
accordance with the ordinary and customary meaning of such
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claim as understood by one of ordinary skill in the art and the
prosecution history pertaining to the patent.
37 C.F.R. § 42.100(b) (2019).7
Under the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303,
1312–19 (Fed. Cir. 2005) (en banc), claim terms are given their ordinary and
customary meaning, as would have been understood by a person of ordinary
skill in the art at the time of the invention, in light of the language of the
claims, the specification, and the prosecution history of record. See Thorner
v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012).
We construe terms only to the extent necessary to resolve the controversy.
Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d
1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).8
1. Overview of the Claim Construction Dispute
Independent claim 1 recites, inter alia, “determin[ing] that the
measurement of the physiological parameter satisfies an alarm activation
threshold” and “initiat[ing] a parameter-specific alarm delay or suspension
period of time.” Ex. 1001, 7:39–8:12 (emphases added). Independent

7 Although our rules state that “[a]ny prior claim construction determination
concerning a term of the claim in a civil action, or a proceeding before the
International Trade Commission, that is timely made of record in the inter
partes review proceeding will be considered” (37 C.F.R. § 42.100(b)), no
such construction is of record in this proceeding.
8 In our Institution Decision, we preliminary determined that the claims do
not require a “predetermined, fixed, or pre-set” period of time. See Inst.
Dec. 25–26. Resolution of this issue, however, is not necessary to resolve
the controversy before us. See, e.g., PO Resp. 66–67; see Nidec, 868 F.3d at
1017.
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claim 13 includes similar limitations. Id. at 9:33–10:14. Independent
claim 18 recites “initiat[ing] a first parameter-specific alarm delay or
suspension period of time” and “delay[ing] or suspend[ing] activation of an
alarm . . . for the first parameter-specific alarm delay or suspension period of
time while the first alarm activation threshold is satisfied.” Id. at 10:38–
11:15 (emphases added).
The arguments and evidence before us raise the question of whether
the claims, when considered as a whole, require suspending activated alarms
only (i.e., post-alarm suspension), or whether the claims also encompass
delaying initial alarm activation (i.e., pre-alarm delays). See Pet. Reply 2.
The Petition presents different grounds to account for these alternate
constructions. Pet. 14. Specifically, the Baker-1 grounds “are directed to a
construction encompassing delays before an alarm is activated (i.e.,
pre-alarm delays),” and the Saidara grounds “are directed to temporary
suspension of active alarms (i.e., post-alarm suspensions).” Id. Thus,
resolution of this question is dispositive as to certain asserted grounds of
unpatentability.
a) “alarm activation threshold”
Claim 1 recites “determin[ing] that the measurement of the
physiological parameter satisfies an alarm activation threshold.” Ex. 1001,
7:55–56; see also id. at 9:56–59 (similar in claim 13); id. at 10:66–11:4
(claim 18 recites “delay[ing] or suspend[ing] activation of an alarm . . .
while the first alarm activation threshold is satisfied by the measurement of
the first measured physiological parameter”).
In the Institution Decision, in addressing Patent Owner’s arguments
distinguishing the asserted art, we preliminarily were “not persuaded that
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satisfying an alarm activation threshold requires actual activation (or
indication) of an alarm,” i.e., triggering an audible or visual alarm indicator.
Inst. Dec. 27; see id. at 26–28.
After institution, Petitioner argues that “[t]he plain meaning of ‘alarm
activation threshold’ necessarily requires the determination that a parameter
exceeds a threshold automatically results in alarm activation.” Pet. Reply 3
(citing Ex. 1040 ¶ 70) (emphasis added).
In the Sur-reply, Patent Owner agrees with our initial determination,
asserting that “meeting the alarm activation threshold is a separate
requirement from activating the alarm.” PO Sur-reply 4–5.
b) “parameter-specific alarm delay or suspension period of time”
Claim 1 recites “initiat[ing] a parameter-specific alarm delay or
suspension period of time corresponding to the physiological parameter.”
Ex. 1001, 7:57–59; see also id. at 10:52–55 (similar in claim 18); id. at
9:47–50, 60–63 (claim 13 recites storing and initiating a first parameter-
specific alarm delay or suspension period of time corresponding to a first
physiological parameter).
Petitioner contends that the claimed “parameter-specific alarm delay
or suspension period of time,” “must be interpreted in light of the
Specification, which only teaches suspension of active alarms,” i.e., alarms
that have already indicated an alarm condition in which a parameter exceeds
an alarm activation threshold by, e.g., emitting audible or visual indicators.
Pet. 14 (citing Ex. 1003 ¶ 45). Petitioner also contends that during
prosecution of the application that issued as the RE244 patent, the Examiner
“rejected the claims in view of prior art that teaches suspending active
alarms.” Id. (citing Ex. 1003 ¶¶ 30, 45; Pet. 10–12).
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However, Petitioner notes that, in the related district court proceeding
(see supra § I.B), Patent Owner asserted that this claim language is satisfied
by systems in which activation of an alarm, e.g., the emission of audible or
visual indicators, is delayed until a measured parameter exceeds a threshold
for a predetermined period of time. Pet. 13–14. In light of these arguments,
Petitioner presumes that Patent Owner’s construction of “alarm delay or
suspension period of time” encompasses a “delay [that] is part of the alarm
threshold,” or in other words, “if the parameter returns to a normal range
within the ‘annunciation delay’ period, the alarm never activates.” Id. at 14
(citing Ex. 1003 ¶ 44).
In our Institution Decision, we did not expressly construe “alarm
delay or suspension period of time,” and we applied the plain and ordinary
meaning of the claim language for purposes of institution. See Inst.
Dec. 23–25. In applying the prior art to the claims, we determined on the
preliminary record that Baker-1’s pre-alarm delay provided a sufficient
showing of this claim limitation for purposes of institution. See id. at 39–42.
We specifically provided instruction to the parties, however, that “[d]uring
trial, the parties are encouraged to develop the record regarding the proper
construction of this phrase in light of the Specification.” Id. at 24–25.
After institution, Petitioner maintains its position that “alarm delay or
suspension period[s] of time” “are time periods in which an activated alarm
is temporarily silenced or deactivated, [which is] the specification’s only
disclosure.” Pet. Reply 3–4 (citing Ex. 1001, 2:33–36, 3:1–2, 3:31–32,
3:58–60, 4:46–48, 4:58–60, 5:51–58, 6:3–9; Ex. 1003 ¶ 45; Ex. 1040 ¶ 71).
Or, in other words, Petitioner maintains the position that the claims are
limited to post-alarm suspensions, and do not encompass pre-alarm delays.
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Despite our instruction to do so, Patent Owner does not address the
construction of “alarm delay or suspension period of time” in the Patent
Owner Response.9 See generally PO Resp. Patent Owner instead asserts
that “[n]one of [its] arguments depend on a different pre-alarm/post-alarm
construction,” and “the parties raise no patentability controversy regarding
the pre-alarm or post-alarm claim scope.” PO Sur-reply 1. Patent Owner
contends that “[t]here’s no need to consider a narrow construction on which
none of [Patent Owner’s] arguments depend.” Tr. 35:11–13; see id. at
34:19–35:19; see also PO Sur-reply 1 (“The Board should not reach this
construction issue.”).
Nonetheless, for the first time, in the Sur-reply, Patent Owner argues
that the Specification of the RE244 does not, in fact, support Petitioner’s
proposed construction that limits the claims to only post-alarm suspensions,
but rather supports its apparent contention that the claims also encompass
pre-alarm delays. See PO Sur-reply 2–5 (citing Ex. 1001, 3:58–4:9, 4:60–
63, 5:60–65, 6:15–20, 6:38–41; Ex. 1042, 118:2–120:20; Ex. 2022, 22:13–
23:2, 23:8–20, 65:20–66:6, 174:2–10).
c) Explicit Construction is Appropriate
Despite Patent Owner’s contention that we need not address this
question of claim construction, the law is clear that obviousness under
35 U.S.C. § 103 is a “two-step inquir[y].” Medichem, S.A. v. Rolabo, S.L.,
353 F.3d 928, 933 (Fed. Cir. 2003); see also Tr. 65:5–16. The first step “is a

9 See Tr. 40:5–16 (Patent Owner’s counsel agreeing Patent Owner was on
notice of the Board’s instruction to develop the record on this issue but,
instead, concluded that “It’s not something that needs to be developed”); see
also id. at 39:7–40:16 (larger discussion).
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proper construction of the claims. . . . The second step in the analys[i]s
requires a comparison of the properly construed claim to the prior art.” Id.
While it is also true that only those claim terms that are in controversy need
to be construed, and only to the extent necessary to resolve the controversy,
see Nidec, 868 F.3d at 1017, a party’s allegation that terms are not disputed,
or that construction is unnecessary because resolution of a different issue
may be dispositive, does not preclude construction. This is especially so
where resolution of a particular claim construction issue also is dispositive to
allegations of unpatentability. See Tr. 8:20–9:1 (Petitioner’s counsel
indicating that if the Board agrees with Petitioner’s contention that “these
patents are properly construed as not covering [pre-alarm] delays . . . then
the grounds 1 through 4 [(i.e., the Baker-1 grounds)] are out. You would not
have to decide grounds 1 through 4 if you decide our way” on the claim
construction question.); id. at 35:3–6 (Patent Owner’s counsel noting that
“[Patent Owner] has never disputed that the claims will cover both
[pre-alarm delays and post-alarm suspensions] and in fact none of [Patent
Owner’s] arguments depend on a narrower construction. Not a single page
of [Patent Owner’s] briefs makes an argument based on the narrow
construction.”); id. at 39:10–40:16 (Patent Owner’s counsel discussing the
strategic decision not to address the issue related to Petitioner’s proposed
narrow construction).
For purposes of this Decision, to resolve the issues raised by
Petitioner’s asserted grounds, we construe “alarm activation threshold” and
“alarm delay or suspension period of time” only to the extent that we find
that the claims, when considered as a whole, do not encompass pre-alarm
delays. Our reasoning follows.
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2. The Parties’ Reliance on the RE244 Specification
Both Petitioner and Patent Owner contend that the Specification of the
RE244 patent supports its respective position.
a) Petitioner’s Position
As Petitioner notes, “[n]either ‘alarm activation threshold’ nor ‘alarm
delay or suspension period of time’ appear in the specification” of the
RE244 patent. Pet. Reply 2.
Petitioner contends that the Specification “only teaches suspension of
active alarms.” Pet. 14 (citing Ex. 1003 ¶ 45); see also Ex. 1040 ¶ 63.
According to Petitioner,
The specification only describes a system that (1) compares a
measured parameter to set limits; (2) automatically activates an
alarm when the parameter is out-of-limits; (3) thereafter,
suspends the activated alarm for a “parameter-specific” duration
in response to a user request; and (4) “resumes,” “retriggers,” or
“reactivates” the alarm after the suspension duration.
Pet. Reply 2–3 (citing, inter alia, Ex. 1003 ¶¶ 21–25, 45, 46; Ex. 1040 ¶ 64).
Petitioner cites the Abstract in support of its claim construction
position (see id. at 2–3), which teaches, “An alarm suspend system utilizes
an alarm trigger responsive to physiological parameters and corresponding
limits on those parameters. . . . Audible and visual alarms respond to the
alarm trigger. An alarm silence button is pressed to silence the audible
alarm for a predetermined suspend time.” Ex. 1001, code (57) (emphasis
added).
Petitioner also cites numerous portions of the RE244 Specification in
support of its position that the claims are limited to suspensions of active
alarms (see Pet. Reply 2–4). For example, Petitioner relies upon the
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Specification’s disclosure that “alarms are triggered by out-of-limit
parameters and system failures.” Ex. 1001, 2:18–19.
Petitioner also relies upon the Specification’s teachings that, when an
active alarm is suspended by a user, it will remain suspended for a
predetermined period of time but will be reactivated if the triggering
condition persists. Id. at 2:33–38. Specifically, the Specification teaches
that “[a]n audible alarm may be temporarily suspended by pressing an alarm
silence button so as to prevent unnecessary disturbance to the patient and
distraction of the caregiver. During alarm suspension, visual alarms remain
active. If an alarm condition persists after a predetermined alarm suspend
period, the audible alarm resumes.” Id. (emphasis added).
The Specification further explains that the suspension period “is
typically long enough to give a caregiver sufficient time to intervene with
appropriate patient treatment yet short enough to ensure that patient health is
not endangered if intervention is ineffective.” Id. at 2:38–42; see also id. at
2:55–57 (“When patient treatment time exceeds the maximum alarm
suspend period, an audible alarm will constantly reactivate.”); id. at 2:57–60
(“[A] single alarm suspend duration for all parameters is inadequate to cope
with the many different types of parameters measured by the advanced
monitors.”).
Petitioner additionally relies upon the following portions of the
Specification, which are consistent with the disclosures discussed above; the
cited portions of the Specification repeatedly describe that an alarm is
automatically triggered when an alarm activation threshold is satisfied, the
activated alarm may be suspended by a user, and the alarm will reactivate if
the alarm activation threshold is still satisfied:
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One aspect of an alarm suspend system for silencing the
alarms is an alarm trigger responsive to any of various
parameters and predetermined limits corresponding to the
parameters . . . . An audible alarm is responsive to the alarm
trigger. An alarm silence button is actuated so as to suspend the
audible alarm. A timer tracks the duration of the suspended
alarm and is initiated by actuation of an alarm silence button.
The timer retriggers the audible alarm after the timed duration
has lapsed/expired.
Ex. 1001, 2:61–3:6 (emphases added).
Another aspect of an alarm suspend system is a partition
of measured parameters into at least a first group and a second
group. An audible alarm is triggered if at least one parameter is
outside of predetermined limits. The audible alarm is suspended
in response to a silence request. A first duration is associated
with the first group and a second duration is associated with the
second group. The audible alarm is reactivated after at least one
of the first duration and the second duration.
Id. at 3:28–36 (emphases added).
A further aspect of an alarm suspend system deactivates
an audible alarm for one of a short duration and a long duration
according to the alarm-triggering parameter. A first group of
parameters is associated with the short duration and a second
group of parameters is associated with the long duration. The
first group and the second group are partitioned according to a
fast treatment time and a short treatment time associated with the
parameters.
Id. at 3:58–65 (emphasis added).
The speaker 150 provides an audible alarm in response to
physiological measurements that violate preset conditions, such
as an out-of-limit parameter, as well as system failures, such as
a low battery condition. The controls 140 include an alarm
silence button 144 that is pressed to temporarily suspend out-of-
limit parameter alarms and system alarms, such as low battery.
Id. at 4:42–48 (emphases added).
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The alarm silence button 144 is pressed to temporarily suspend
audible alarms. Advantageously, an alarm suspend system
provides a parameter-dependent variation in the alarm suspend
duration, as described below, utilizing a common silence button
or other suspend initiator.
Id. at 4:58–63 (emphasis added).
As shown in FIG. 3, measured parameters 312 are
compared 310 to default or user-specified limits 314. An out-of-
limit condition 318 triggers an alarm 340. An alarm suspend
328 is user-initiated by a silence request 322. This may be a
press of a silence button 144 (FIG. 1) on a monitor front panel
110 (FIG. 1). In an embodiment, the alarm suspend 328 silences
audible alarms and modifies the display of visual alarms. The
alarm suspend 328 is based on a timer 320, which ends the alarm
suspend 328 after a predetermined duration 324. The duration
324 may be a function of the out-of-limit parameter 312. In an
advantageous embodiment, the duration 324 relates to, or is a
function of, the treatment time for the alarm-triggering parameter
so as to avoid nuisance alarms while maintaining alarm integrity.
Id. at 5:51–65 (emphases added).
FIG. 4 illustrates an alarm suspend embodiment 400 that
operates independently for each measured parameter that can
trigger an alarm. An alarm is initially off 410. The alarm
remains off as long as the parameter is within its set limits 412.
If a parameter is measured outside of its set limits 414, an alarm
is triggered 420. The alarm may audible, visual or both audible
and visual. A user can request to silence the alarm by pressing
an alarm silence button 144 (FIG. 1), for example. The silence
request 422 suspends the alarm 430 which turns off audible
alarms but, in an embodiment, does not deactivate visual alarms.
The audible alarm remains suspended 430 for a predetermined
duration 432. When the suspend duration has passed, the alarm
suspend expires 434 and audible alarms are once again
activated 420. The alarm remains on 428 until the triggering
parameter is within limits 424 or a user once again requests
silence 422.
Id. at 5:66–6:14 (emphases added).
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b) Patent Owner’s Position
Patent Owner, in turn, argues that the Specification “explains how a
processor would immediately delay or suspend an alarm rather than activate
an alarm.” PO Sur-reply 2. In support, Patent Owner cites the following
portions of the Specification (see id.):
A further aspect of an alarm suspend system deactivates
an audible alarm for one of a short duration and a long duration
according to the alarm-triggering parameter. A first group of
parameters is associated with the short duration and a second
group of parameters is associated with the long duration. The
first group and the second group are partitioned according to a
fast treatment time and a short treatment time associated with the
parameters. An override reactivates the audible alarm if the
trigger parameter changes more than a predetermine amount
during the corresponding duration. In various embodiments, the
first group comprises parameters related to the measurement of
normal hemoglobin and the second group comprises parameters
related to the measurement of abnormal hemoglobin. The long
duration is greater than about 120 seconds and the short duration
is less than or equal to about 120 seconds. A pop-up window for
the display allows selection of the long duration and the short
duration in response to the silence button.
Ex. 1001, 3:58–4:9.
Other alarm features apply to both slow treatment and fast
treatment parameters. For example, an alarm delay of 0, 5, 10 or
15 seconds applies to all enabled parameters.
Id. at 6:38–41.
Patent Owner also notes that the Specification “expressly
contemplates ‘other suspend initiator[s]’ besides a user request, and does not
require reactivation after a temporary delay.” PO Sur-reply 3 (citing
Ex. 1001, 4:60–63, 6:15–20) (alteration in original). The cited portions of
the Specification teach:
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Advantageously, an alarm suspend system provides a
parameter-dependent variation in the alarm suspend duration, as
described below, utilizing a common silence button or other
suspend initiator.
Ex. 1001, 4:60–63.
The alarm suspend 430 deactivates if the measured
parameter becomes within limits 438, such as when the patient
condition improves, or if no physiological data is detected 439,
such as no sensor, sensor off, no cable or malfunctioning sensor
situations, to name a few.
Id. at 6:15–20.
Patent Owner also argues that “the specification relates to situations
where a condition that would otherwise cause an alarm resolves after some
time without a clinician intervening.” PO Sur-reply 3. Patent Owner cites
the following disclosure: “The duration 324 may be a function of the out-of-
limit parameter. In an advantageous embodiment, the duration 324 relates
to, or is a function of, the treatment time for the alarm-triggering parameter
so as to avoid nuisance alarms while maintaining alarm integrity.” Ex. 1001,
5:60–65.
Patent Owner relies on the testimony of its expert, Mr. Goldberg, in
support of its position that the Specification provides support for pre-alarm
delays. PO Sur-reply 4 (citing Ex. 1042, 118:3–120:20).
3. Discussion
Contrary to Patent Owner’s assertions, we find that every disclosed
embodiment of the claimed invention includes suspension of an activated
alarm and no disclosed embodiment includes parameter-specific pre-alarm
delays. Based on the overwhelming and clear disclosure in the Specification
of the RE244 patent, we agree with Petitioner that “the correct
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construction—the construction that most accurately delineates the scope of
the claimed invention” requires delay or suspension of an activated alarm,
and precludes delays or suspensions that occur before activation of an alarm,
i.e., pre-alarm delays. See PPC Broadband, Inc. v. Corning Optical
Comm’ns RF, LLC, 815 F.3d 734, 740–42 (Fed. Cir. 2016).
We recognize that we do not import limitations from the Specification
into the claims. Thorner, 669 F.3d at 1366–67 (“We do not read limitations
from the specification into claims.”). It is indisputable, however, that claims
must be interpreted in light of the Specification of which they are a part.
Phillips, 415 F.3d at 1315–1316. This is because the claims “do not stand
alone. Rather, they are part of ‘a fully integrated written instrument,’
consisting principally of a specification that concludes with the claims. For
that reason, claims ‘must be read in view of the specification, of which they
are a part.’” Id. As the Court of Appeals for the Federal Circuit has stated,
“the specification is always highly relevant to the claim construction
analysis. Usually, it is dispositive; it is the single best guide to the meaning
of a disputed term.” Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576,
1582 (Fed. Cir. 1996) (“[I]ntrinsic evidence is the most significant source of
the legally operative meaning of disputed claim language.”).
The Specification in this case is overwhelmingly clear that to construe
the claims to encompass pre-alarm delays, as Patent Owner suggests, would
be inconsistent therewith.10 See Power Integrations, Inc. v. Fairchild

10 The claims of the RE244 patent recite “parameter-specific alarm delay or
suspension period of time.” We recognize that our construction does not
give separate meaning to the “delay or” portion of the claim. However,
“[t]he preference for giving meaning to all terms, however, is not an
inflexible rule that supersedes all other principles of claim construction.”
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Semiconductor Int’l, Inc., 711 F.3d 1348, 1360–63 (Fed. Cir. 2013)
(affirming a narrower claim construction, where the specification reflects
that the patentee did not consider broader claim scope as part of the
invention); see also Netword, LLC v. Centraal Corp., 242 F.3d 1347, 1352
(Fed. Cir. 2001) (“The claims are directed to the invention that is described
in the specification; they do not have meaning removed from the context
from which they arose. . . . Although the specification need not present every
embodiment or permutation of the invention and the claims are not limited
to the preferred embodiment of the invention, neither do the claims enlarge
what is patented beyond what the inventor has described as the invention.”
(internal citations omitted)).
Based on the arguments and evidence of record, we are persuaded by
Petitioner’s evidence demonstrating that the claims do not encompass
pre-alarm delays. As Petitioner demonstrates, the Specification consistently
and exclusively discloses suspending only active alarms, in which an audible
or visual indicator has been activated as a result of a monitored parameter
exceeding a designated threshold. See, e.g., Ex. 1001, 2:33–38 (“An audible
alarm may be temporarily suspended by pressing an alarm silence
button . . . . If an alarm condition persists after a predetermined alarm
suspend period, the audible alarm resumes.”), 2:61–3:6 (“An audible alarm
is responsive to the alarm trigger. An alarm silence button is actuated so as
to suspend the audible alarm.”), 3:28–36 (“An audible alarm is triggered if at

SimpleAir, Inc. v. Sony Ericsson Mobile Communications AB, 820 F.3d 419,
429 (Fed. Cir. 2016); see also ERBE Elektromedizin GmbH v. Canady Tech.
LLC, 629 F.3d 1278, 1286 (Fed. Cir. 2010) (“surplusage may exist in some
claims”). See Tr. 7:3–6 (Petitioner’s counsel confirming that Petitioner is
proposing the same construction also for the claims of the RE244 patent).
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least one parameter is outside of predetermined limits. The audible alarm is
suspended in response to a silence request.”), 3:58–65 (“A further aspect of
an alarm suspend system deactivates an audible alarm.”), 4:42–48 (“The
speaker 150 provides an audible alarm in response to physiological
measurements that violate preset conditions, such as an out-of-limit
parameter, as well as system failures, such as a low battery condition. The
controls 140 include an alarm silence button 144 that is pressed to
temporarily suspend out-of-limit parameter alarms and system alarms, such
as low battery.”), 4:58–63 (“The alarm silence button 144 is pressed to
temporarily suspend audible alarms.”), 5:51–65 (“An out-of-limit condition
318 triggers an alarm 340. An alarm suspend 328 is user-initiated by a
silence request 322. This may be a press of a silence button 144 (FIG. 1) on
a monitor front panel 110 (FIG. 1).”), 5:66–6:14 (“If a parameter is
measured outside of its set limits 414, an alarm is triggered 420. The alarm
may [be] audible, visual or both audible and visual. A user can request to
silence the alarm by pressing an alarm silence button 144 (FIG. 1), for
example. The silence request 422 suspends the alarm 430 which turns off
audible alarms but, in an embodiment, does not deactivate visual alarms.”).
We have reviewed the entirety of the Specification, including the
portions cited by Patent Owner, and we discern no disclosure in which a
parameter-specific alarm is delayed or prevented from activating in the first
place. Patent Owner’s arguments to the contrary are not persuasive.
As noted above, Patent Owner points to the Specification’s disclosure
that “[o]ther alarm features apply to both slow treatment and fast treatment
parameters. For example, an alarm delay of 0, 5, 10 or 15 seconds applies to
all enabled parameters” (Ex. 1001, 6:38–41). See PO Sur-reply 2. This
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disclosure, however, does not relate to the claimed “parameter-specific
alarm delay or suspension period of time.” Rather, the Specification
expressly states that the delay discussed at column 6, lines 38–41 “applies to
all enabled parameters.” Ex. 1001, 6:38–41 (emphases added); see Pet. 14
(quoting Ex. 1001, 6:38–49; citing Ex. 1003 ¶¶ 24, 45); Pet. Reply 4 n.2. As
such, this is plainly not the parameter-specific alarm delay or suspension
period of time recited in the claims. Patent Owner’s counsel admits as
much. Tr. 77:3–11 (acknowledging that “[i]n that specific example [at
Ex. 1001, 6:39–40] it’s talking about an alarm delay that apparently is not
being applied specifically”); see also id. at 76:4–78:9 (larger discussion);
ERBE Elektromedizin GmbH v. Int’l Trade Com’n, 566 F.3d 1028, 1034–36
(Fed. Cir. 2009) (disclosure of an unrelated feature in the specification does
not support a broader claim construction where the specification does not tie
that feature to the disputed claim language, particularly where inconsistent
with the rest of the specification).
Patent Owner also relies on Mr. Goldberg’s deposition testimony. PO
Sur-reply 4–5. We recognize Mr. Goldberg’s testimony that, “in reading the
patent as a whole, I believe that pre-alarm delays are, in fact, disclosed.”
Ex. 1042, 118:2–13. When pressed to show support in the Specification,
however, Mr. Goldberg pointed, first, to the disclosed “other suspend
initiator” and, second, to the disclosed alarm suspend firmware that, he
contends, “implies . . . a[n] ability to suspend the alarm other than by the
alarm silence [button].” See id. at 118:20–123:4 (pointing to Ex. 1001,
4:60–63, 5:37, Figs. 2, 4). We do not find this testimony or Patent Owner’s
argument persuasive. First, that the claimed system could suspend the alarm
in a manner other than the described silence button (i.e., with the “other
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suspend initiator”), does not alter the fact that the Specification only
discloses suspending an alarm after it has been activated. Second, the
firmware upon which Mr. Goldberg relies is disclosed as “respond[ing] to an
alarm silence button press 288.” Ex. 1001, 5:38–41. Accordingly, we give
little weight to Mr. Goldberg’s conclusory testimony that pre-alarm delays
are disclosed, because this testimony is unsupported by any persuasive cited
evidence. See 37 C.F.R. § 42.65(a).
The other portions of the Specification cited by Patent Owner (PO
Sur-reply 2–4) also are not persuasive. One cited portion of the
Specification indicates that the “alarm suspend system deactivates an
audible alarm for one of a short duration and a long duration according to
the alarm-triggering parameter. . . . An override reactivates the audible
alarm if the trigger parameter changes more than a predetermine[d] amount
during the corresponding duration.” Ex. 1001, 3:58–4:1 (emphases added)
(cited at PO Sur-reply 2). Contrary to Patent Owner’s position, we discern
that, in order to be deactivated, the alarm must first be activated. This
understanding is consistent with the remainder of the Specification, which
consistently describes that “[a]n audible alarm is triggered if at least one
parameter is outside of predetermined limits” (Ex. 1001, 3:30–31), i.e., when
“the measurement of the physiological parameter satisfies an alarm
activation threshold” (see, e.g., id. at 7:55–56 (claim 1)). Similarly, in order
for an alarm to be reactivated as described in the portion of the Specification
cited by Patent Owner, it must have been previously activated prior to the
action by the alarm suspend system which deactivated it.
A second cited portion indicates that the “duration 324 relates to, or is
a function of, the treatment time for the alarm-triggering parameter so as to
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avoid nuisance alarms while maintaining alarm integrity.” Ex. 1001, 5:62–
65 (cited at PO Sur-reply 3). Patent Owner is correct that this portion of the
Specification reflects a desire to minimize nuisance alarms, but we do not
agree that this disclosure indicates that a condition may resolve without
triggering an alarm, as Patent Owner’s argument suggests. PO Sur-reply 3.
Rather, the portion of the Specification leading up to that cited by Patent
Owner explains that
[a]n out-of- limit condition 318 triggers an alarm 340. An alarm
suspend 328 is user-initiated by a silence request 322. . . . In an
embodiment, the alarm suspend 328 silences audible alarms and
modifies the display of visual alarms. The alarm suspend 328 is
based on a timer 320, which ends the alarm suspend 328 after a
predetermined duration 324.
Ex. 1001, 5:51–60. Accordingly, the cited disclosure is consistent with the
remainder of the Specification, which indicates that an alarm is
automatically triggered by an out-of-condition parameter, which may be
suspended or held by a user’s silence request.
Accordingly, and for the reasons discussed, we determine that the
claims do not encompass pre-alarm delays.
D. Obviousness over the Combined Teachings of Saidara and Malangi
Petitioner asserts that claims 1, 2, 6–9, 13–15, and 18–26 would have
been obvious over the combination of Saidara and Malangi. Pet. 62–84. As
noted above, see supra § II.C, this asserted ground of unpatentability is
“directed to temporary suspension of active alarms (i.e., post-alarm
suspensions).” Pet. 14.
Patent Owner disputes Petitioner’s contentions, arguing that Saidara
and Malangi involve “very different devices” with different users and
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environments, that Petitioner fails to provide a sufficient or supported
motivation to combine them, and that the combination fails to disclose a
multiple parameter device. PO Resp. 46–64.
1. Overview of Saidara (Ex. 1008)
Saidara is a U.S. Patent titled “System for Monitoring Physiological
Characteristics.” Ex. 1008, code (54).
Saidara describes “apparatuses and methods for monitoring
physiological characteristics such as blood glucose levels” or other
characteristics, such as oxygen saturation. Id. ¶¶ 13, 60. Saidara’s
monitoring system may include electrode sensors placed on the external
surface of the skin or below the skin layer of the user to monitor
physiological characteristics. Id. ¶ 70 (disclosing “other types of sensors,”
e.g., “electrically based sensors, chemically based sensors, optically based
sensors, or the like”).
Saidara also discloses that the system may “provide[] additional
functions that will aid in the treatment regime,” for example, “the monitor
may track meals, exercise and other activities which affect the treatment of
diabetes.” Id. ¶ 66. Moreover, the monitor may “be coupled to an infusion
pump that can further provide a medication to a user. Optionally the
monitor is designed to be inconspicuous, for example a monitor design that
resembles a wristwatch.” Id. Saidara explains that the system may display
and/or log monitored information, which can then be downloaded for data
analysis. Id. ¶ 75. “In further embodiments, the characteristic monitoring
system 100, 200 can be used in a hospital environment, or the like.” Id.
Saidara discloses that alarms may be triggered based on various
monitored conditions, e.g., high or low blood glucose markers
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(hyperglycemia and hypoglycemia, respectively). Id. ¶ 28. Saidara’s
Figure 4D is reproduced below.

Figure 4D illustrates a flowchart of display screens that may be utilized to
establish a hypoglycemia alarm. Id. ¶ 44. For example, through low limit
entry screen 428, a user can “specify that the hypoglycemia alarm will
trigger if the user’s blood glucose level is less than or equal to” a desired
level, e.g., 60, 65, or 70 mg/dL. Id. ¶ 129.
Additional screens include, e.g., alarm repeat display screen 432,
which “allows the user to set a period for delaying a repeated check of the
hypoglycemia alarm condition.” Id. ¶ 130; see also id. ¶ 32 (“prevent[s]
redundant alarms for a specified period”). “For the low limit alarm level, the
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alarm repeat delay period can be selected from a group of values differing in
10 minute increments. For example, the alarm repeat delay period can be
selected from 20, 30, 40, 50 and 60 minutes for the low limit alarm level.”
Id. ¶ 130. Saidara describes similar approaches for setting a hyperglycemia
alarm, with alarm repeat delay periods selected among 1, 1½, 2, 2½, and
3 hours. Id. ¶¶ 44, 131–132, Fig. 4E.
Additionally, the alarm repeat delay function can be set differently for
hypoglycemic and hyperglycemic alarms of different severity. Id. ¶ 133.
Saidara explains, “[i]f a lower threshold hyperglycemic alarm is triggered, a
relatively long repeat delay may be invoked. However, if a higher threshold
hyperglycemic alarm is triggered, a shorter repeat delay may be used so that
the user is warned more frequently because of the severity of his condition.”
Id.
Saidara also describes an alarm snooze function for temporarily
disabling an alarm. Id. ¶ 138. “[A]lthough both the alarm repeat delay
function and the alarm snooze function prevent alarms for specified periods,
they are not the same.” Id. ¶ 139. “The alarm repeat delay is initiated . . . in
response to a first alarm. In contrast, the alarm snooze function is activated
by the user directly, either by directing the monitor to snooze immediately or
scheduling a snooze at a specified time.” Id.
2. Overview of Malangi (Ex. 1010)
Malangi is a thesis published by the New Jersey Institute of
Technology titled “Simulation and Mathematical Notation of Alarms Unit
for Computer Assisted Resuscitation Algorithm.” Ex. 1010, Title.
Malangi describes “a software system used to drive [a saline infusion]
pump responsible for fluid resuscitation of patients suffering from conditions
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that lead to hypotension,” under operation of a caregiver or paramedic. Id.
at 1–2.11 The system includes a number of alarms that communicate when
various undesirable conditions occur, e.g., falling blood pressure (“BP”). Id.
at 6. “Alarms may be silenced for a given period of time by pressing a soft
‘silence alarm’ button on the screen. All active alarms are reset if there is a
‘pump unplugged’ alarm.” Id. at 7.
Malangi’s Table 2.1 is reproduced below, and lists various alarm
causes with associated priorities and silence times.

Table 2.1 identifies situations associated with various alarms, wherein each
alarm is associated with a priority level and a silence time. Id. at 7.
The alarms are controlled by various procedures and functions,
including “Function silencealarms,” which “silences the alarm when
caregiver chooses to silence it. It calls the Reminder in which a timer is set
for the silence time of that particular alarm.” Id. at 12–13, 18–19. For
example, “Falling Patient BP” is associated with a silence time of “2,”

11 Citations in this Decision reference the native page numbers in Malangi,
not the page numbers added in Petitioner’s exhibit.
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whereas the condition of “Failure to reach 60 mmHg . . .” is associated with
a silence time of “5.” Id. at 6–7.
3. Discussion of Independent Claim 1
a) “A physiological measurement system comprising”
Petitioner asserts that, to the extent it is limiting, Saidara discloses the
subject matter of the preamble of claim 1. Pet. 62–63. Petitioner contends
that Saidara discloses “methods and systems for ‘monitoring physiological
characteristics.’” Id. at 63 (citing, e.g., Ex. 1008 ¶ 60).
The evidence of record supports Petitioner’s undisputed contention.
Saidara discloses “methods and systems for the convenient operation of
monitoring physiological characteristics.” Ex. 1008 ¶ 60.
b) “a noninvasive physiological sensor configured to be
positioned on a patient and output a signal responsive to a
physiological condition of the patient”
Petitioner contends that Saidara discloses sensor set 102, which may
use a variety of sensor types including optically-based sensors and dermal
sensors, and which outputs and communicates signals responsive to
conditions of a patient to a monitor. Pet. 63 (citing Ex. 1008 ¶¶ 66, 70).
Petitioner contends that Saidara teaches that its system can measure SpO2
and that a person of ordinary skill in the art would have been motivated to
use a typical non-invasive pulse oximeter sensor to perform this SpO2
measurement, because it would provide more comfort and flexibility than an
invasive or implantable sensor. Id. (citing Ex. 1008 ¶¶ 12, 30, 76; Ex. 1003
¶¶ 167–168).
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Patent Owner argues that Saidara teaches a user-focused single-
parameter glucose monitor.12 PO Resp. 46, 53. Patent Owner also argues
that it is unclear how Saidara’s typically invasive implanted or subcutaneous
glucose monitor would have been modified to employ a non-invasive sensor,
especially given Dr. Yanulis’s testimony that non-invasive glucose sensors
were neither taught by Saidara nor commercially available in 2008. Id. at
49, 61, 62 n.7 (citing Ex. 2018, 412:10–413:9, 421:6–19); see also PO Sur-
reply 21, 23, 25.
We determine that the evidence of record supports Petitioner’s
contentions. Saidara discloses “sensor set 102,” which “produces a signal
that corresponds to a measured characteristic of the user, such as a blood
glucose level. The sensor set 102 communicates these signals to a
characteristic monitor 104 that is designed to interpret these signals.”
Ex. 1008 ¶ 66 (emphasis added). Although Saidara’s primary embodiment
monitors glucose, Saidara expressly discloses that its embodiments are
applicable to “a wide variety” of additional physiological characteristics,
specifically including SpO2. Id. ¶ 60. Indeed, Saidara explains that sensor
set 102 also monitors oxygen saturation, for use in calibrating the sensor. Id.
¶ 76. That glucose is a primary embodiment does not discount Saidara’s
clear teaching of additional monitoring embodiments. See In re Lamberti,
545 F.2d 747, 750 (CCPA 1976).
Moreover, Saidara discloses various types of sensors, including
“optically based sensors,” “dermal” sensors, and sensors “used on the

12 Many of Patent Owner’s arguments are directed to the combination of
Saidara and Malangi. We address the arguments applicable to each
limitation, as best we can discern them.
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external surface of the skin.” Ex. 1008 ¶¶ 60, 70. Even accepting Patent
Owner’s contention that, as of 2008, glucose was monitored invasively (PO
Resp. 62 n.7), that does not diminish Saidara’s express disclosure that “other
types of sensors” can be used in sensor set 102. Ex. 1008 ¶¶ 60, 70. We
credit Dr. Yanulis’s undisputed testimony that, when Saidara’s sensor set
102 monitors SpO2, as Saidara expressly contemplates, a person of ordinary
skill in the art would have utilized a non-invasive pulse oximeter sensor
because this was “the most common type” of sensor for performing SpO2
measurements and would have improved patient comfort, flexibility, and
quality of life as compared to an invasive sensor. Ex. 1003 ¶ 170; see also
Ex. 1042, 23:2–11 (Mr. Goldberg’s testimony that pulse oximeters are used
“to evaluate oxygen saturation” and “are noninvasive”).
We do not agree with Patent Owner’s characterization of the Petition
as “propos[ing] to modify Saidara’s invasive blood glucose monitor into a
non-invasive monitor.” PO Resp. 62 n.7. Saidara clearly explains that the
system “include[s] the capability for simultaneous monitoring of multiple
sensors and/or include a sensor for multiple measurements.” Ex. 1008 ¶ 73.
Petitioner does not contend that the non-invasive SpO2 pulse oximeter would
also monitor glucose. Petitioner only proposes modifying Saidara’s sensor
set 102 to use a noninvasive pulse oximeter sensor to monitor SpO2. Pet. 63.
Petitioner does not propose any alteration to how glucose is monitored by
Saidara’s sensor set 102. Contra PO Resp. 46–47, 48–49, 53.
For the foregoing reasons, we determine that the evidence of record
supports Petitioner’s contentions that a person of ordinary skill in the art
would have used “a noninvasive physiological sensor configured to be
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positioned on a patient and output a signal responsive to a physiological
condition of the patient,” when measuring SpO2 in Saidara.
c) “one or more processors in communication with the
noninvasive physiological sensor, the one or more processors
configured to electronically . . .”
Petitioner contends that Saidara discloses communicating sensor
signals to processor 108, and that such disclosure accounts for the above-
noted limitation. Pet. 64 (citing, e.g., Ex. 1008 ¶ 66).
The evidence of record supports Petitioner’s undisputed contention.
Saidara discloses that “sensor set 102 communicates these signals to a
characteristic monitor 104,” which includes processor 108. Ex. 1008 ¶ 66,
Fig. 1A.
d) “the one or more processors configured to electronically . . .
process the signal”
Petitioner contends that Saidara discloses that processor 108 processes
the signal received from the sensor set. Pet. 64 (citing, e.g., Ex. 1008 ¶ 66,
Fig. 1A).
The evidence of record supports Petitioner’s undisputed contention.
Saidara discloses that “sensor signals enter the monitor 104 through a sensor
input 106 and through the sensor input 106 the signals are conveyed to a
processor 108,” which “determines and manipulates the sensor readings
within the monitor 104” to obtain “characteristic reading[s].” Ex. 1008 ¶ 66.
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e) “the one or more processors configured to electronically . . .
responsive to processing the signal, determine a measurement
of a physiological parameter based at least in part upon the
signal”
Petitioner contends that Saidara discloses that processor 108
determines measurements of physiological parameters based upon the signal
received from the sensor set. Pet. 64 (citing, e.g., Ex. 1008 ¶¶ 66, 76, 125–
127); see also Ex. 1008, Fig. 1A.
The evidence of record supports Petitioner’s undisputed contention.
As noted, Saidara discloses that “sensor signals enter the monitor 104
through a sensor input 106 and through the sensor input 106 the signals are
conveyed to a processor 108,” which “determines and manipulates the
sensor readings within the monitor 104” to obtain “characteristic readings.”
Ex. 1008 ¶ 66; see also id. ¶ 76 (also disclosing that “oxygen saturation level
can be determined by measuring signals from the various electrodes of the
sensor set 103” for use “in calibration of the sensor set 102”).
f) “the one or more processors configured to electronically . . .
determine that the measurement of the physiological
parameter satisfies an alarm activation threshold”
Petitioner contends that Saidara discloses determining whether the
measured parameter satisfies an alarm activation threshold. Pet. 64 (citing,
e.g., Ex. 1008 ¶¶ 125–127).
The evidence of record supports Petitioner’s undisputed contention.
Saidara discloses that
the monitor includes a sensor input capable of receiving a signal
from a sensor, the signal being based on a sensed physiological
characteristic value of a user, and a processor for operating an
alarm based on user input from an input device. The alarm
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indicates an alarm condition where the sensed physiological
characteristic value exceeds a set range.
Ex. 1008 ¶ 125; see also id. ¶ 127 (determining whether hypoglycemia exists
by comparing the measured blood glucose level to a 60 mg/dL activation
threshold, and activating a visual, audible, tactile, and/or vibratory alarm
when the threshold is satisfied).
g) “the one or more processors configured to electronically . . .
initiate a parameter-specific alarm delay or suspension period
of time corresponding to the physiological parameter, the
parameter-specific alarm delay or suspension period of time
being one of a plurality of parameter-specific alarm delay or
suspension periods of time, the parameter-specific alarm delay
or suspension period of time being different from at least one
other parameter-specific alarm delay or suspension period of
time corresponding to at least one other physiological
parameter for which the one or more processors are
configured to determine at least one measurement”
Petitioner’s Contentions
Petitioner contends that Saidara discloses an “alarm repeat delay
period” during which subsequent alarms are prevented after a first alarm is
activated. Pet. 64–65 (citing Ex. 1008 ¶¶ 128, 139); see supra § II.D.3.f
(alarm activated after threshold satisfied).
Petitioner explains that Saidara discloses the alarm repeat delay period
in the context of glucose alarms, where the delay period can be “set
differently for hypoglycemic alarms and hyperglycemic alarms of different
severities.” Pet. 65 (citing Ex. 1008 ¶ 133). Again, Petitioner explains that
Saidara’s teachings apply to other parameters, including SpO2. Id. (citing
Ex. 1008 ¶¶ 60, 76). Thus, Petitioner contends that a person of ordinary skill
in the art would have been motivated to modify Saidara’s glucose
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monitoring device to also “monitor additional physiological parameters and
apply different alarm repeat delay periods to these parameters.” Id. (citing
Ex. 1003 ¶ 174). Petitioner relies upon Dr. Yanulis’s testimony that
monitoring and providing different alarm repeat delay periods to additional
physiological parameters, like SpO2, would have provided “more
comprehensive data about a patient and [achieved] the same predictable
result,” namely, “prevent[ing] distraction to the caregiver from ongoing
audible alarms or new alarms triggered by medical intervention, while also
providing a caregiver with intermittent and repeated warnings corresponding
to the severity of a continuing or worsening alarm condition that may require
escalated or additional medical intervention.” Ex. 1003 ¶ 174 (cited at
Pet. 65–66) (also opining that “clinicians would know the proper alarm
repeat delay periods to apply to different physiological parameters” based on
their training and experience treating various conditions); see supra
§ II.D.3.b (modifying Saidara’s sensor set 102 to noninvasively monitor
SpO2).
“To the extent Saidara does not disclose specific examples of alarm
repeat delay periods for the identified additional monitored physiological
characteristics,” Petitioner also relies upon Malangi’s teaching of silencing
blood pressure alarms for various periods of time corresponding to the
severity of the blood pressure measurement. Pet. 66–67 (citing, e.g.,
Ex. 1010, Table 2.1). Petitioner contends this teaching is similar to
Saidara’s disclosure of applying different alarm delay periods based on the
severity of the monitored parameter. Id. at 67 (citing Ex. 1003 ¶ 178).
Based on these teachings, Petitioner further contends that a person of
ordinary skill in the art would have been motivated to modify Saidara’s
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glucose monitoring device to also “measure additional physiological
parameters, including SpO2 and BP . . . and apply different alarm suspension
periods corresponding to different parameters and the severity of a
parameter measurement.” Id. at 68 (citing Ex. 1003 ¶ 178). Petitioner relies
upon Dr. Yanulis’s testimony that this would have allowed for
comprehensive monitoring of a patient’s health and would have ensured “a
caregiver acknowledges the currency of alarms and can provide medical
treatment without triggering additional alarms caused by the medical
intervention.” Ex. 1003 ¶ 178 (cited at Pet. 68).
Patent Owner’s Arguments
Patent Owner argues that Saidara and Malangi teach “very different
devices (glucose monitor versus saline infusion system), with different users
(patient-user versus paramedic) in dramatically different environments
(home use versus combat zone).” PO Resp. 46, 53–54.
Patent Owner argues that Saidara is a single-parameter glucose
monitor for a patient-user at home, with features to help track aspects of a
user’s lifestyle that might impact treatment of diabetes, such as meals, sleep,
and exercise, so that the patient-user may adequately care for themselves.
Id. at 46–48, 53–54. Patent Owner argues that Petitioner does not cite
anything to suggest Saidara’s monitor is operated by a medical caregiver.
Id. at 47. Patent Owner also argues that although Saidara provides a
“generic statement” regarding other physiological parameters, Saidara
provides no details about how to measure other parameters and fails to
indicate why its alarms would be relevant for other parameters. Id. at 48;
see also PO Sur-reply 24. Finally, Patent Owner argues there is no
suggestion to combine Saidara’s glucose-related alarms with alarms related
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to SpO2, which is measured only for calibration purposes and is not reported
to the patient-user or used to generate an alarm. PO Resp. 48–49, 63.
Patent Owner argues that Malangi also concerns single-parameter
monitoring of only blood pressure. Id. at 50. Patent Owner argues that
Malangi discloses a software simulation for a high output saline infusion
pump to be used by a caregiver during war or other critical situations, when
the patient is in a life-threatening state. Id. at 49–50, 54.
Given these differences, Patent Owner argues that the Board’s
Institution Decision correctly determined (preliminarily) that there was an
insufficient motivation to combine Saidara and Malangi. Id. at 51–53.
According to Patent Owner, Petitioner’s purported motivations underlying
the proposed combination—comprehensive patient monitoring, minimized
distractions, warnings for severe conditions—do not apply to Saidara
because the device is worn by a patient-user at home, without a caregiver
present. Id. at 55, 60.13
Patent Owner also argues that the modification presumes that more
monitoring is better, which is inconsistent with both references’ focus on
single parameter monitoring. Id. at 56. According to Patent Owner, multi-
parameter monitoring “would (1) increase device complexity by requiring
additional sensors, wires, and programmable features, potentially confusing
a patient-user; (2) complicate specific devices features (e.g., alarm settings

13 Patent Owner also argues that Petitioner’s caregiver-focused reasoning is
inconsistent with the contention that use of a non-invasive sensor would
improve patient comfort. PO Resp. 55–56. For the reasons discussed in
§ II.D.3.b and below, we find Petitioner’s reasoning as to both modifications
to be sound. Indeed, improving patient comfort through noninvasive SpO2
monitoring and comprehensively monitoring multiple conditions are
simultaneously desirable in the context of medical devices.
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and review); (3) increase the size of the device, making it more noticeable;
and (4) increase cost.” Id. (citing Ex. 2011 ¶¶ 167–168), 60–61 (citing Ex.
200514 ¶ 29; Ex. 2011 ¶¶ 168, 172). Patent Owner also argues that
Petitioner’s proposed combination rests solely on Dr. Yanulis’s testimony
providing “a generic motivation,” which is unsupported by any evidence and
modularly combines disparate references to supply a missing claim
limitation, i.e., multi-parameter monitoring. Id. at 57–60.
Finally, Patent Owner argues that Petitioner fails to explain how to
modify either reference in light of the other, and leaves it to the Board to
piece together the combination. Id. at 54–55, 62. According to Patent
Owner, even if Saidara and Malangi were combined, “the result would have
still been a single-purpose device monitoring a single physiological
parameter.” Id. at 61. For example, Patent Owner argues that it is unclear
how to incorporate Saidara’s invasive glucose monitor with Malangi’s blood
pressure cuff. Id. at 61–62. Patent Owner argues that “[o]ther modifications
(e.g., incorporating a pulse oximeter) would likewise disrupt Saidara’s goal
of inconspicuous monitoring.” Id. at 62 (citing Ex. 2011 ¶ 176).
Discussion – Blood Pressure
As an initial matter, we agree with Patent Owner’s arguments about
the proposed modification of Saidara to include blood pressure monitoring
and alarming. Primarily, we agree that Petitioner fails to meet its burden of
explaining how a person of ordinary skill in the art would have incorporated
Malangi’s teaching of blood pressure monitoring and alarming with
Saidara’s device. PO Resp. 54–55, 61–62.

14 Ex. 2005 is the Declaration of Dr. Yanulis submitted in IPR2020-00912.
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The Petition provides limited guidance in this regard. Petitioner
contends that it would have been obvious to also monitor blood pressure
with Saidara’s device, as taught by Malangi, and provides reasons why such
a modification would have been desirable. Pet. 68. Even accepting these
reasons, for the sake of argument, the Petition is silent as to how a skilled
artisan would have implemented Malangi’s teachings in Saidara. Id. at 66–
68.
In its Reply, Petitioner cites testimony that is insufficient to support its
contentions. For example, Petitioner relies upon the testimony of its expert,
Dr. Bergeron, that a person of ordinary skill in the art “understood how [to]
measure blood pressure.” Ex. 1040 ¶ 111; Pet. Reply 23. Petitioner also
relies on the testimony of Patent Owner’s expert, Mr. Goldberg, that blood
pressure cuffs were prevalent. Ex. 1042, 45:18–46:7; Pet. Reply 23. Both
points may well be true. However, neither Petitioner, nor the cited expert
testimony, explains persuasively how a skilled artisan would have known
how to integrate Malangi’s teaching of monitoring and alarming for blood
pressure (whether using a prevalent and well-known blood pressure cuff or
any other device) with Saidara’s particular system, nor do they discuss the
detriments or benefits of such a modification, e.g., the increased size and
complexity of incorporating a blood pressure cuff into Saidara’s device. It is
Petitioner’s burden to do so. It is insufficient to merely establish that it was
known to use blood pressure cuffs to monitor that parameter.15

15 Petitioner also cites to U.S. Patent No. 10,213,108 (Pet. Reply 25), but the
cited portion only describes that a communications adapter can be applied
to, e.g., a non-invasive blood pressure sensor, among various other sensors,
but fails to explain whether or how the blood pressure sensor is integrated
with other sensors. Ex. 1047, 5:15–24.
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For the foregoing reasons, we agree with Patent Owner that Petitioner
fails to explain sufficiently how a person of ordinary skill in the art would
have modified Saidara to also monitor, alarm, and delay alarms for blood
pressure, and leaves it to the Board to piece together the proposed
modification. PO Resp. 61–62; but see Pet. Reply 25, and Ex. 1040 ¶¶ 111–
113 (explaining how, apart from blood pressure monitoring, SpO2
monitoring and alarming would have been achieved in the combination).
Discussion – Oxygen Saturation
We are persuaded, however, by Petitioner’s contention that Saidara
teaches that its processor accesses an alarm repeat setting function that
establishes (“one or more processors . . . initiate[s]”) an alarm repeat delay
period (“alarm delay or suspension period of time”) for a monitored
parameter. Pet. 64–65. Saidara explains that, through this functionality,
“[s]ubsequent alarms are prevented for the alarm repeat delay period after
the measurement of the concentration of blood glucose first indicates a
glycemic condition.” Ex. 1008 ¶ 128; see also id. ¶ 130 (selecting alarm
repeat setting function to set delay period).
Patent Owner is correct that Saidara teaches this delay period in the
context of glucose monitoring, where different delay periods may be
established for hypoglycemia, for hyperglycemia, or for different severities
of either condition. See, e.g., PO Resp. 46–47, 53–54; Ex. 1008 ¶¶ 130
(hypoglycemia examples), 131 (hyperglycemia examples), 133 (based on
severity). However, we are persuaded by Petitioner’s contention that a
person of ordinary skill in the art would have found it obvious to also
monitor additional parameters, i.e., SpO2, and to implement a suspension
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period for this additional parameter. Pet. 65–66; see supra § II.D.3.b
(modifying Saidara’s sensor set 102 to noninvasively monitor SpO2).
Indeed, Saidara expressly teaches that its embodiments apply to SpO2
(Ex. 1008 ¶ 60), that its system is capable of simultaneously monitoring
multiple sensors and including a sensor for multiple measurements (id.
¶ 73), and that various alarms and monitoring aspects may be combined with
other alarms and monitoring aspects (id. ¶ 173). See, e.g., Pet. Reply 22–23.
Thus, contrary to Patent Owner’s argument (PO Resp. 57–60), Saidara
strongly suggests its use for multi-parameter monitoring and supports
Petitioner’s reasoning. Dr. Yanulis’s testimony that monitoring, alarming,
and applying alarm repeat delay periods for additional parameters would
have “provide[d] more comprehensive data about a patient” and would have
“prevent[ed] distraction” from ongoing alarms is also supported by these
portions of Saidara. Ex. 1003 ¶ 174; Pet. Reply 24. Dr. Bergeron’s
testimony is also consistent with Saidara’s teachings. Ex. 1040 ¶¶ 102–104,
112–114.
We disagree with Patent Owner’s argument that Saidara provides only
a “generic statement” regarding other parameters, and does not suggest
“combining glucose-related alarms with alarms relating to oxygen saturation
measurements.” PO Resp. 48, 63; see also Ex. 2011 ¶¶ 177–178. Saidara
discloses monitoring glucose. And, even though glucose may be the
preferred embodiment, “all disclosures of the prior art, including unpreferred
embodiments, must be considered” in determining obviousness. Lamberti,
545 F.2d at 750; see also Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d
1371, 1380 (Fed. Cir. 2005) (“[T]hat a particular combination is not a
preferred embodiment does not teach away absent clear discouragement of
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that combination.”). Accordingly, it would be inappropriate to discount
Saidara’s express disclosures that its embodiments apply to SpO2 and that
multiple parameters may be monitored simultaneously. Ex. 1008 ¶¶ 60, 73,
173; see also Ex. 1043, 324:3–17 (Patent Owner’s expert, Mr. Goldberg,
agreeing, “Saidara [at Ex. 1008 ¶ 73] says, an embodiment can include more
than one sensor, yes. . . . A person of skill reading that would, would
conclude that if you have multiple sensors, that they likely serve different
purposes, and could monitor more than one physiological characteristic.”).
We also disagree with Patent Owner’s argument that SpO2 is
measured only for calibration purposes and is not reported or used to
generate an alarm. PO Resp. 63; PO Sur-reply 23 (also arguing SpO2 uses
an invasive probe, but see supra § II.D.3.b). This argument ignores the
proposed modification. Although Saidara itself does not disclose using the
SpO2 calibration measurement for reporting or alarming, we are persuaded
that Saidara would have suggested as much to a skilled artisan, given
Saidara’s express teaching that its embodiments apply to SpO2 (Ex. 1008
¶ 60), that the system is capable of simultaneous monitoring of multiple
parameters (id. ¶ 73), and that various alarms and monitoring aspects may be
combined (id. ¶ 173).
We also are persuaded that Malangi’s teaching of correlating the
severity of a parameter measurement with the duration of an alarm
suspension period would have motivated a person of ordinary skill in the art
to modify Saidara to “apply different alarm suspension periods
corresponding to . . . the severity of a parameter measurement in order to
ensure a caregiver acknowledges the currency of alarms and can provide
treatment without triggering additional alarms.” Pet. 68; Ex. 1003 ¶ 178.
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This reasoning, and Dr. Yanulis’s testimony, is supported by Saidara’s
disclosure of the importance of alarming based on severity, such that an
intervention can be taken in the appropriate time frame before repeated
alarms occur. For example, Saidara discloses:
the alarm repeat delay function can be set differently for
hypoglycemic alarms and hyperglycemic alarms of different
severities. If a lower threshold hyperglycemic alarm is triggered,
a relatively long repeat delay may be invoked. However, if a
higher threshold hyperglycemic alarm is triggered, a shorter
repeat delay may be used so that the user is warned more
frequently because of the severity of his condition.
Ex. 1008 ¶ 133. Dr. Bergeron’s testimony also supports this reasoning.
Ex. 1040 ¶ 110 (“Malangi simply shows that if you were to add additional
physiological characteristics to the device of Saidara (as it expressly states
can be done according to its embodiments), that a [person of ordinary skill in
the art] would know to apply different suspension times to different
parameters based on the urgency of the parameter measurement and typical
treatment time for the alarming parameter.”); see also Pet. Reply 23–24.
We have considered Patent Owner’s argument that Saidara and
Malangi contemplate different users, different goals, and different
environments, such that the benefits proposed by Petitioner do not apply to
Saidara. PO Resp. 46–48, 49–51, 53–55, 60–61; see also Inst. Dec. 49–50.
Having considered the full record developed during trial, we do not agree.
In response to Patent Owner’s arguments, Petitioner explains that Saidara
discloses that its system can be used “in a hospital environment.” Pet.
Reply 20–22, 24; Ex. 1008 ¶ 75. We are persuaded that, in such an
environment, a caregiver would be involved in most patient monitoring, as
Saidara suggests. See Ex. 1008 ¶ 74 (“Embodiments of the invention are
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also useful as an evaluation tool under a physician’s supervision.”);
Ex. 1043, 309:2–310:14 (“[A] person of skill would assume that most of the
patients in a hospital do not have self-monitoring devices that they come in
with.”).
Moreover, even if Saidara’s system is only utilized by a patient-user,
the record shows persuasively that patient-users themselves also would
benefit from comprehensive monitoring, minimized distractions, and
warnings for severe conditions, as suggested by Saidara and Malangi. As
Dr. Bergeron testified,
[i]n a situation where a user is providing their own medical
treatment . . . the user would also not want to be bothered by
continuous alarms while the condition is being treated, but would
need to know if the treatment is not working by receiving
intermittent warnings that the parameter measurement has not yet
returned to normal levels.
Ex. 1040 ¶ 115; see also Ex. 1008 ¶¶ 60 (disclosing that its embodiments are
“applicable to a wide variety of patient treatment programs . . . to use in
estimating the responsive treatment”), 73 (“simultaneous monitoring”), 128
(disclosing that “[s]ubsequent alarms are prevented for the alarm repeat
delay period after the measurement of the concentration of blood glucose
first indicates a glycemic condition”), 133 (disclosing that “if a higher
threshold hyperglycemic alarm is triggered, a shorter repeat delay may be
used so that the user is warned more frequently because of the severity of his
condition”); Ex. 1010, Table 2.1; see also Pet. Reply 24.
We have also considered Patent Owner’s argument, and the evidence
cited in support, that multi-parameter monitoring would create a host of
problems, inconsistent with Saidara’s and Malangi’s focus on single
parameter monitoring. PO Resp. 56 (citing Ex. 2011 ¶¶ 167–168), 60–61
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(citing Ex. 2005 ¶ 29; Ex. 2011 ¶¶ 168, 172). We recognize the cited
testimony of both parties’ experts, which reflects a general desire to
minimize the size of wearable devices to improve patient comfort.
However, Patent Owner fails to reconcile its argument with Saidara’s
express suggestion to monitor multiple parameters simultaneously and to
combine various alarms. Ex. 1008 ¶¶ 73 (“further embodiments can include
the capability for simultaneous monitoring of multiple sensors and/or
include a sensor for multiple measurements”), 173 (“[v]arious alarms and/or
monitoring aspects discussed above may be combined or utilized with other
alarms and/or monitoring aspects”). So, while it may be true that smaller
devices may impart certain benefits in certain circumstances, Saidara also
reflects a desire to perform multi-parameter monitoring. As discussed
above, we are persuaded by Petitioner’s contentions that a person of
ordinary skill in the art would have been motivated to do so, e.g., to provide
more comprehensive monitoring. Pet. 65–68; Ex. 1003 ¶¶ 174, 178.
Unlike for the proposed modification regarding blood pressure, we are
persuaded that Petitioner explains sufficiently how a person of ordinary skill
in the art would have incorporated SpO2 monitoring and alarming with
Saidara’s device. For example, the Petition explains that Saidara already
discloses monitoring SpO2 with sensor set 102, albeit for calibration
purposes. Pet. 65; Ex. 1008 ¶¶ 60, 76; see also supra § II.D.3.b (modifying
Saidara’s sensor set 102 to noninvasively monitor SpO2). In light of these
teachings, Petitioner’s expert, Dr. Bergeron, opines that a person of ordinary
skill in the art would have found it to be “a simple act of programming to
have the Saidara system take the SpO2 measurement from the sensor set and
display and monitor it according to Saidara’s embodiments.” Ex. 1040
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¶¶ 111–113. Patent Owner does not dispute this testimony or argue that
monitoring and alarming based on both glucose and SpO2 would have been
beyond the level of skill in the art.
Finally, we are persuaded that, in this modification, the alarm delay or
suspension period of time is “one of a plurality of parameter-specific alarm
delay or suspension periods of time” and is “different from at least one other
parameter-specific alarm delay or suspension period of time” for another
parameter. Specifically, Saidara’s parameter-specific delay or suspension
periods for hypoglycemia and hyperglycemia both differ from the SpO2-
specific delay or suspension period. Pet. 65; Ex. 1008 ¶¶ 128, 130–133.
h) “the one or more processors configured to electronically . . .
activate an alarm for the physiological parameter in response
to expiration of an amount of delay or suspension associated
with the parameter-specific alarm delay or suspension period
of time”
Petitioner contends that Saidara discloses activating an alarm after
expiration of the alarm repeat delay period. Pet. 68–70 (citing Ex. 1008
¶¶ 128, 133, Figs. 4D–4F; Ex. 1003 ¶¶ 180–183).
The evidence of record supports Petitioner’s undisputed contentions.
Specifically, as discussed above, Saidara discloses that an “alarm indicates
an alarm condition where the sensed physiological characteristic value
exceeds a set range.” Ex. 1008 ¶ 125; see supra § II.D.3.f. If an alarm
repeat delay period duration has been set through the alarm repeat setting
function, see supra § II.D.3.g, the processor determines to delay or suspend
subsequent indications of the alarm, such that “[s]ubsequent alarms are
prevented for the alarm repeat delay period after[, e.g.,] the measurement of
the concentration of blood glucose first indicates a glycemic condition.”
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Ex. 1008 ¶ 128. As discussed above, we are persuaded by Petitioner’s
contentions that a person of ordinary skill in the art would have found it
obvious to modify Saidara such that alarm repeat delay periods would have
been set for glucose and for SpO2. See supra § II.D.3.g.
Additionally, we credit Dr. Yanulis’s undisputed testimony that, if an
alarm condition still persists after the alarm repeat delay period, the alarm is
activated. Ex. 1003 ¶¶ 181–183; Ex. 1008 ¶ 125 (alarm if measured value
exceeds range).
i) Conclusion as to Claim 1
For the reasons discussed above, we determine that Petitioner has met
its burden of demonstrating by a preponderance of the evidence that claim 1
is unpatentable as obvious over Saidara and Malangi.
4. Discussion of Independent Claim 13
As to independent claim 13, Petitioner primarily relies upon its
contentions made with respect to claim 1, and also identifies where Saidara
teaches other limitations of the claim. See Pet. 75–77; see also id. at 75
(identifying memory 110; citing Ex. 1008 ¶ 67). Patent Owner primarily
relies upon the same arguments discussed above with respect to claim 1. See
PO Resp. 46–63. Patent Owner does, however, present additional arguments
as to a single limitation of claim 13. See id. at 63–64. We discuss the
parties’ contention as to this limitation here.
Claim 13 recites, inter alia, that “responsive to processing the signal,
electronically determining a first measurement of a first physiological
parameter and a second measurement of a second physiological parameter.”
Ex. 1001, 9:41–44 (emphasis added).
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Petitioner contends that “Saidara discloses its embodiments are
applicable to a wide variety of physiological parameters, including, for
example, SpO2,” and that a person of ordinary skill in the art “would have
been motivated to modify Saidara to measure additional physiological
parameters, including those identified in Saidara and/or BP as disclosed in
Malangi,” to provide comprehensive data about a patient. Pet. 72, 75 (citing,
e.g., Ex. 1003 ¶ 174; Pet. 65–66 (which cites Ex. 1008 ¶¶ 60, 76), 72 (which
cites Ex. 1003 ¶ 187)).
Patent Owner contends that claim 13 “require[s] using the same signal
to determine two different physiological parameters.” PO Resp. 64.
According to Patent Owner, “Petitioner does not identify two parameters
determined using the same signal,” nor does Petitioner cite any evidence that
the parameters of Saidara are determined from the same signal. Id.
In its Reply, Petitioner responds that, in Saidara, the same signal from
“the same ‘sensor set 102’ is used to determine blood glucose and SpO2
measurements.” Pet. Reply 26 (citing Ex 1040 ¶¶ 112–113). Although
sensor set 102 monitors SpO2 for sensor calibration purposes, Petitioner
contends a person of ordinary skill in the art “would have had a reasonable
expectation of success in displaying and monitoring the same SpO2
measurements obtained from the signal received from ‘sensor set 102.’” Id.
In its Sur-reply, Patent Owner argues that the claims “require the
same signal, not just the same sensor set, to determine two different
measurements,” and Saidara’s “‘sensor set’ signal, used for sensor
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calibration, is from an invasive monitor, whereas claims 1 and 13 are
noninvasive sensors.”16 PO Sur-reply 25.
We determine that Patent Owner’s arguments do not adequately
account for what a person of ordinary skill in the art would have understood
from Saidara’s teachings. Instead, we are persuaded by Petitioner’s
contentions. Saidara teaches that “sensor set 102 . . . employs a sensor that
produces a signal that corresponds to a measured characteristic of the user,
such as a blood glucose level.” Ex. 1008 ¶ 66; see also id. ¶ 76 (also
disclosing that sensor set 102 can monitor SpO2 and temperature). Saidara
also explains that “sensor set 102 communicates these signals to a
characteristic monitor 104 that is designed to interpret these signals to
produce a characteristic reading or value for the user, i.e. a measurement of
the characteristic.” Id. ¶ 66. And, Saidara’s Figure 1A depicts sensor
signals from sensor set 102 being communicated to processor 108. Id. (“The
sensor signals enter the monitor 104 through a sensor input 106 and through
the sensor input 106 the signals are conveyed to a processor 108.”). As
discussed above, Saidara also explains that multiple sensors can be
monitored simultaneously, and that a sensor may include multiple
measurements. Id. ¶ 73.
Based on these teachings, we agree with Petitioner that a skilled
artisan would have reasonably appreciated that the same signal from

16 PO also argues that “Sotera fails to substantively address” claims 13–15
and 19–22, which do not depend from claim 8. PO Sur-reply 25.
Petitioner’s Reply, however, lists each of claims 8, 9, 13–15, and 19–22 with
respect to this discussion. Pet. Reply 26. Also, the portion of the Petition to
which Petitioner cites in the Reply (i.e., regarding limitation 8(a), at Pet. 72),
is cross-referenced in the Petition with respect to the relevant limitation of
claim 13 (see Pet. 75) and claim 19 (see id. at 80).
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Saidara’s sensor set 102 may be used to determine first and second
parameter measurements, e.g., blood glucose (id. ¶ 66) and SpO2 (id. ¶ 76).
See also id. Fig. 1A (depicting a sensor signal provided to input 106 and to
processor 108). Although Saidara refers at times to multiple “signals,” see,
e.g., id. ¶ 66, it does not follow that Saidara mandates separate signals for
each one of the parameter measurements that Saidara describes as being
communicated from sensor set 102. We credit Dr. Bergeron’s testimony to
that effect as it is consistent with Saidara’s disclosure. See Ex. 1040 ¶¶ 111–
113 (“[A] PHOSITA would have a reasonable expectation of success in
displaying and monitoring the same SpO2 measurements obtained from the
signal from ‘sensor set 102’, which is also used to measure blood glucose,
since the processor has already calculated these values for calibration.”).
We recognize Patent Owner’s argument that claim 1 recites a
noninvasive sensor. PO Sur-reply 25. However, as discussed above in
§ II.D.3.b, we are persuaded by Petitioner’s contention that a person of
ordinary skill in the art would have used a noninvasive sensor when
monitoring SpO2. Use of a noninvasive sensor within sensor set 102 to
monitor SpO2 does not preclude use of an invasive sensor within that same
sensor set to measure blood glucose, as Patent Owner argues is required.
See, e.g., PO Resp. 62 n.7. Thus, we are persuaded that one of ordinary skill
in the art would have recognized from Saidara’s teachings that the same
signal from sensor set 102 is communicated to sensor input 106 and to
processor 108, and may be used to determine measurements of two
monitored parameters, e.g., blood glucose and SpO2. Ex. 1008 ¶ 66,
Fig. 1A; see also Ex. 1003 ¶ 187 (“It is common in the medical field that a
particular patient will require more than one vital sign parameter be
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monitored while under the care of medical professionals. In such
circumstances, it is highly desirable, and therefore obvious, to use one
machine to monitor multiple vital sign parameters as opposed to using one
machine to monitor only one parameter.”).
As noted above, Patent Owner does not offer any additional separate
arguments as to the patentability of claim 13 beyond those addressed above
for claim 1. See PO Resp. 46–64. Accordingly, Patent Owner has waived
any such challenge. See Paper 14, 8 (“Patent Owner is cautioned that any
arguments not raised in the response may be deemed waived.”); NuVasive,
Inc., 842 F.3d at 1380–81; Consolidated Trial Practice Guide 52 (Nov.
2019).
As discussed above, we are not persuaded by Patent Owner’s
arguments as to claim 1, or the additional arguments presented as to claim
13. Having considered the record before us, and for the same reasons, we
are persuaded that Petitioner has met its burden of demonstrating by a
preponderance of the evidence that claim 13 is unpatentable as obvious over
Saidara and Malangi.
5. Discussion of Independent Claim 18
Petitioner relies upon its contentions made with respect to claim 1,
and also identifies where Saidara teaches other limitations of independent
claim 18. See Pet. 77–79 (identifying memory 110); Ex. 1008 ¶ 67 (memory
110). Patent Owner does not offer separate arguments as to the patentability
of claim 18 beyond those addressed above for claim 1.17 See PO Resp. 46–

17 Patent Owner also argues that Petitioner’s analysis of the “means
limitation” in claim 18 is “facially deficient.” PO Resp. 65–66. According
to Patent Owner, claim 18 recites “a physiological sensor means” and the
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64. Accordingly, Patent Owner has waived any such patentability challenge.
See Paper 14, 8.
As discussed above, we are not persuaded by Patent Owner’s
arguments as to claim 1. Having considered the record before us, and for the
same reasons, we are persuaded that Petitioner has met its burden of
demonstrating by a preponderance of the evidence that claim 18 is
unpatentable as obvious over Saidara and Malangi.
6. Discussion of Dependent Claims 2, 6–9, 14, 15, 19–26
a) Claims 2, 6, 7, and 23–26
Petitioner contends that dependent claims 2, 6, 7, and 23–26 would
have been obvious over the combined teachings of Saidara and Malangi.
Pet. 70–72, 81–84; see also, e.g., Ex. 1008 ¶¶ 60, 76, 117–121, 130, 132,
133, Figs. 4A, 4D–4E; Ex. 1003 ¶¶ 184–186, 226–231.

Petition does not provide a means-plus-function construction as required by
37 C.F.R. § 42.104(b)(3). Id. Petitioner replies that “the limitation recites
sufficient structure” to perform the specified function (i.e., “outputting a
signal responsive to a physiological condition of a patient” (Ex. 1001,
10:39–42)). Pet. Reply 27 (citing Ex. 1040 ¶ 117). In the Sur-reply, Patent
Owner contends that Petitioner has the burden on this issue. PO Sur-reply
26–27. We credit Dr. Bergeron’s testimony that a person of ordinary skill in
the art “would understand that a ‘physiological sensor means’ is just a
physiological sensor that provides signals to a processor for measuring
physiological parameters.” Ex. 1040 ¶ 117 (cited at Pet. Reply 27). We find
that the limitation includes sufficient structure to perform the claimed
function, and thus, is not a means-plus-function limitation. See TriMed, Inc.
v. Stryker Corp., 514 F.3d 1256, 1259–1260 (Fed. Cir. 2008) (the
presumption that § 112 ¶ 6 applies is overcome if “the claim recites
sufficient structure for performing the described functions in their
entirety”)).
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Patent Owner does not offer any separate arguments as to the
patentability of these dependent claims beyond those presented for claim 1.
See PO Resp. 46–64. Accordingly, Patent Owner has waived any such
challenge. See, e.g., Paper 14, 8.
As discussed above, we are not persuaded by Patent Owner’s
arguments as to claim 1. Having considered the record before us, we are
persuaded that Petitioner has met its burden of demonstrating by a
preponderance of the evidence that claims 2, 6, 7, and 23–26 are
unpatentable as obvious over Saidara and Malangi. Pet. 70–72, 81–84.
b) Claims 8, 9, 14, 15, and 19–22
Claim 8 depends from independent claim 1 and recites, inter alia, that
the processor is configured to “determine a measurement of a second
physiological parameter based at least in part upon the signal.” Ex. 1001,
8:51–53. Claim 19 depends from independent claim 18 and likewise recites
that “the second measurement,” of a second physiological parameter, is
determined “based at least in part upon the signal.” Id. at 11:19–21. These
limitations are similar to the specific limitation of claim 13 discussed above.
Claim 9 depends from claim 8; claims 14 and 15 depend from claim 13; and
claims 20–22 depend from claim 19.
Petitioner contends that dependent claims 8, 9, 14, 15, and 19–22
would have been obvious over the combined teachings of Saidara and
Malangi. Pet. 72–75, 77, 80–81; see also, e.g., Ex. 1008 ¶¶ 60, 76, 117–121,
134–136, Fig. 4A; Ex. 1010, 7, 12, 19–20, 35; Ex. 1003 ¶¶ 174–179, 187–
192, 205–207, 218–225.
Patent Owner does not offer any separate arguments as to the
patentability of these dependent claims beyond those presented for claims 1
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and 13. See PO Resp. 46–64. Accordingly, Patent Owner has waived any
such challenge. See, e.g., Paper 14, 8.
As discussed above, we are not persuaded by Patent Owner’s
arguments as to claims 1 or 13. Having considered the record before us, we
are persuaded that Petitioner has met its burden of demonstrating by a
preponderance of the evidence that claims 8, 9, 14, 15, and 19–22 are
unpatentable as obvious over Saidara and Malangi. Pet. 72–75, 77, 80–81.
7. Conclusion
For the foregoing reasons, we conclude that Petitioner has shown
where all the features of claims 1–2, 6–9, 13–15, and 18–26 of the RE244
patent are found in the combined teachings of Saidara and Malangi. We also
conclude that Petitioner has shown that a person of ordinary skill in the art
would have had adequate reason to combine teachings of Saidara and
Malangi. As such, we determine that Petitioner has met its burden of
demonstrating by a preponderance of the evidence that claims 1–2, 6–9, 13–
15, and 18–26 are unpatentable as obvious over Saidara and Malangi.
E. Obviousness over the Combined Teachings of Saidara, Malangi, and
Hickle
Petitioner contends that dependent claims 3–5, 10–12, 14, 16–17, and
26 would have been obvious over the combined teachings of Saidara,
Malangi, and Hickle, relying upon Hickle for the features of these dependent
claims. Pet. 84–87; see, e.g., Ex. 1009 ¶¶ 3, 80, 152; Ex. 1003 ¶¶ 233–246.
Patent Owner does not offer any separate arguments as to the
patentability of these dependent claims beyond those presented for
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independent claims 1 and 13. See PO Resp. 65. Accordingly, Patent Owner
has waived any such challenge. See, e.g., Paper 14, 8.
As discussed above, we are not persuaded by Patent Owner’s
arguments as to claims 1 or 13. Having considered the record before us, we
are persuaded that Petitioner has met its burden of demonstrating by a
preponderance of the evidence that claims 3–5, 10–12, 14, 16–17, and 26
would have been obvious over the combined teachings of Saidara, Malangi,
and Hickle. Pet. 84–87.
F. Obviousness over Baker-1, Batchelder, Baker-2, and Hickle
Petitioner contends that:
claims 1, 6–8, 13, 14, 18, 19, and 23–26 of the RE244 patent
are unpatentable as obvious over Baker-1 (Pet. 29–50);
claims 1, 2, 6–9, 13–15, and 18–26 are unpatentable as obvious
over Baker-1 and Batchelder (id. at 50–56);
claims 1, 2, 6–9, 13–15, and 18–26 are unpatentable as obvious
over Baker-1, Batchelder, and Baker-2 (id. at 56–59); and
claims 3–5, 10–12, 16, and 17 are unpatentable as obvious
over Baker-1, Batchelder, Baker-2, and Hickle (id. at 59–62).
As noted in the Claim Construction analysis, the asserted grounds of
unpatentability based on Baker-1 are “directed to a construction
encompassing delays before an alarm is activated (i.e., pre-alarm delays).”
Pet. 14. As discussed, however, we determine that the claims do not
encompass pre-alarm delays. See supra § II.C (Claim Construction). We,
therefore, do not reach these alternative grounds of unpatentability. See also
Tr. 8:20–9:1 (Petitioner’s counsel indicating that if the Board agrees with
Petitioner’s contention that “these patents are properly construed as not
covering [pre-alarm] delays . . . then the grounds 1 through 4 [(i.e., the
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Baker-1 grounds)] are out. You would not have to decide grounds 1 through
4 if you decide our way” on the claim construction question.).
G. Motion to Exclude
Petitioner moves to exclude portions of Exhibits 2017 and 2022.
MTE 1, 3, 5. We do not rely upon the identified portions of the exhibits and,
as such, dismiss the Motion to Exclude as moot.
III. CONCLUSION
In summary:18
Claims 35 U.S.C. § Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims Not
Shown
Unpatentable
1, 6–8, 13,
14, 18, 19,
23–26
103
Baker-119

1, 2, 6–9,
13–16, 18–
26
103 Baker-1,
Batchelder19

1, 2, 6–9,
13–15, 18–
26
103 Baker-1,
Batchelder,
Baker-219

18 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg.
16654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
19 As explained above, we do not reach this ground of unpatentability. See
supra § II.F.
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3–5, 10–12,
16, 17
103 Baker-1,
Batchelder,
Baker-2,
Hickle19

1, 2, 6–9,
13–15, 18–
26
103 Saidara,
Malangi
1, 2, 6–9, 13–
15, 18–26

3–5, 10–12,
16, 17, 26
103 Saidara,
Malangi,
Hickle
3–5, 10–12,
16, 17, 26

Overall
Outcome
1–26
IV. ORDER
Upon consideration of the record before us, it is:
ORDERED that claims 1–26 of the RE244 patent have been shown to
be unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude
(Paper 37) is dismissed as moot; and
FURTHER ORDERED that, because this is a final written decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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FOR PETITIONER:
Rudolph A. Telscher, Jr.
Daisy Manning
Nathan P. Sportel
Jennifer Hoekel
HUSCH BLACKWELL LLP
PTAB-RTelscher@huschblackwell.com
PTAB-DManning@huschblackwell.com
Nathan.Sportel@huschblackwell.com
PTAB-JHoekel@huschblackwell.com

FOR PATENT OWNER:
Stephen W. Larson
Jacob L. Peterson
Irfan A. Lateef
Brian C. Claassen
Jeremiah S. Helm, Ph.D.
Jarom D. Kesler
KNOBBE, MARTENS, OLSON, & BEAR, LLP
2swl@knobbe.com
2jup@knobbe.com
2ial@knobbe.com
2bcc@knobbe.com
2jgh@knobbe.com
2jzk@knobble.com