Masimo Corporation

Patent Trials and Appeals Board

Nov 29, 2021

IPR2020-01078 (P.T.A.B. Nov. 29, 2021)

Trials@uspto.gov Paper 35
571-272-7822 Date: November 29, 2021

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

SOTERA WIRELESS, INC.,
Petitioner,

v.

MASIMO CORPORATION,
Patent Owner.
____________

IPR2020-01078
Patent RE47,218 E

____________

Before GEORGE R. HOSKINS, JENNIFER MEYER CHAGNON, and
AMANDA F. WIEKER, Administrative Patent Judges.

HOSKINS, Administrative Patent Judge.

JUDGMENT
Final Written Decision
Determining All Challenged Claims Unpatentable
35 U.S.C. § 318(a)
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I. INTRODUCTION
Sotera Wireless, Inc. (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
pursuant to 35 U.S.C. §§ 311–319 to institute an inter partes review of all
claims 1–10 and 12–18 of U.S. Patent No. RE47,218 E (Ex. 1001,
“the ’218 patent”). Masimo Corporation (“Patent Owner”) opposes the
Petition. We instituted the petitioned review (Paper 12, “Institution
Decision” or “Inst. Dec.”).
Patent Owner filed a Patent Owner Response (Paper 23, “PO Resp.”)
to the Petition. Petitioner filed a Reply (Paper 25, “Pet. Reply”) to the
Patent Owner Response. Patent Owner filed a Sur-reply (Paper 27,
“Sur-reply”) to the Reply. An oral hearing was held, for which the transcript
was entered into the record (Paper 34, “Tr.”).
We have jurisdiction under 35 U.S.C. § 6(b)(4) and § 318(a). This
Decision is a final written decision under 35 U.S.C. § 318(a) and 37 C.F.R.
§ 42.73 as to the patentability of claims 1–10 and 12–18 of the ’218 patent.
We determine Petitioner has shown by a preponderance of the evidence that
claims 1–10 and 12–18 are unpatentable.
II. BACKGROUND
A. Real Parties-in-Interest and Related Proceedings
Sotera Wireless, Inc. and Hon Hai Precision Industry Co., Ltd. are the
real parties-in-interest for Petitioner, and Masimo Corporation is the real
party-in-interest for Patent Owner. Pet. 1; Paper 5, 1. Masimo Corp. v.
Sotera Wireless, Inc. and Hon Hai Precision Industry Co. Ltd., Civil Action
No. 3:19-cv-01100-BAS-NLS (S.D. Cal.) is a related judicial proceeding.
Pet. 2; Paper 5, 1.
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B. The ’218 Patent
The ’218 patent concerns a system for monitoring a patient’s blood
oxygen saturation (SpO2), and generating an alarm if the saturation falls too
low. See Ex. 1001, code (57), 1:34–39, 2:54–58. The system includes an
optical sensor attached to the patient’s finger, to emit light into the fingertip
tissue and detect light that is attenuated by blood flow within the fingertip, to
provide a numerical readout of oxygen saturation. See id. at 1:39–55.
Figure 1 of the ’218 patent is reproduced here:
Figure 1 illustrates a prior art oxygen saturation measurement system having
two “lower-limit, fixed-threshold alarm” schemes, at “delay” alarm
threshold DL and at “no delay” alarm threshold NDL. Id. at 2:54–59
(emphasis added). If the patient’s measured oxygen saturation 110 falls and
stays below delay threshold DL for a time period greater than time delay TD,
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as shown in Figure 1 from time t1 to time t2, then delayed alarm 140 is
triggered. Id. at 2:59–3:2. If the patient’s measured oxygen saturation 110
falls below no delay threshold NDL, as shown in Figure 1 at time t4, then
alarm 150 is triggered immediately, without delay. Id. at 2:61–62, 3:2–4.
According to the ’218 patent, the fixed nature of delay alarm
threshold DL undesirably leads to “a baseline drift problem,” which can
generate a “nuisance” or “false” alarm. Id. at 2:54–56, 3:24–46 (Fig. 3).
The ’218 patent therefore proposes “an adaptive alarm system,” which
adjusts the delay alarm threshold downwards when an oxygen saturation
baseline is established at lower values. Id. at 3:59–62. In this way, the
inventive “alarm threshold . . . adapts to baseline drift in [oxygen saturation]
and reduce[s] false alarms without a corresponding increase in missed true
alarms.” Id. at 4:4–8.
This is illustrated in Figure 6 of the ’218 patent, reproduced here:
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Figure 6 graphs a measured physiological parameter such as oxygen
saturation (the vertical axis) over time (the horizontal axis), as generated by
an alarm system having a lower limit adaptive alarm threshold AT. Id.
at 5:34–36, 7:40–47. An adaptive alarm threshold AT is applied whenever
the measured oxygen saturation falls within range 650, extending from lower
limit L2 up to maximum value Max, such as illustrated at segments 620, 630,
and 640. Id. at 6:15–30, 7:9–67, Fig. 5B (horizontal axis values extend from
L2 to Max). The adaptive thresholds AT are constrained to lie within
range 660, extending from lower limit L2 up to limit L1. Id. at 6:15–30,
7:9–67, Fig. 5A (adaptive threshold AT line 442 is constrained between
limits L2 and L1 along vertical axis).
In a preferred embodiment, lower limit L2 corresponds to the value of
the no delay alarm threshold NDL of the prior art system shown in Figure 1,
and limit L1 corresponds to the value of the delay alarm threshold DL of the
prior art system. Id. at 5:66–6:4, 6:20–34. The fixed alarm threshold that
the prior art implements at limit L1 is replaced by adaptive alarm
thresholds AT. Id. at 6:22–34. Each threshold AT, during a given time
period such as t1, t2, or t3, may advantageously be implemented as a time
delay alarm, as the prior art system does with its fixed delay alarm
threshold DL. Id. at 6:38–43.
The system determines a baseline B of the patient’s oxygen saturation
during different time periods t1, t2, and t3. Id. at 6:11–15, 6:44–7:8. For
each different baseline B, the system applies a different adaptive alarm
threshold AT. Id. at 6:15–19. Specifically, the system calculates delta Δ as
a function of: the varying baseline B; pre-set limits L1 and L2; and maximum
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value Max. Id. at 6:15–34 (Fig. 4A), 7:9–39 (Fig. 5B). The adaptive alarm
threshold is set AT = B – Δ. Id. at 7:27–39 (Fig. 5A), 7:53–8:6 (Fig. 6).
C. The Claims of the ’218 Patent
The ’218 patent lists seventeen claims, numbered 1–10 and 12–18.
Ex. 1001, 1:4–9, 13:62–16:62. As a reissue patent, the claim listing in the
’218 patent uses brackets to identify verbiage removed during the reissue
process, and uses italics to identify verbiage added during the reissue
process. Id. Due to the extent and nature of these reissue amendments, it is
difficult to ascertain the scope of the claimed invention by simply reviewing
the claim listing in the ’218 patent, particularly in the three independent
claims 1, 8, and 12. Id. at 13:62–16:62.
Accordingly, we reproduce claim 1 here, removing the bracketed
verbiage and not italicizing the added verbiage, to ease readability. We also
include Petitioner’s labeling scheme 1(a)–1(i). See Pet. vii–viii.
[1(a)] 1. A system for reducing electronic alarms in a
medical patient monitoring system, the system comprising:
[1(b)] an optical sensor configured to transmit optical
radiation into a tissue site of a patient and detect attenuated
optical radiation indicative of at least one physiological
parameter of a patient; and
[1(c)] one or more hardware processors in electronic
communication with the optical sensor, the one or more
hardware processors configured to:
[1(d)] determine oxygen saturation values of the
patient over a first period of time;
[1(e)] when at least one oxygen saturation value
obtained over the first period of time exceeds a first
alarm threshold, determine whether a first alarm should
be triggered;
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[1(f)] access a second alarm threshold to be
applied during a second period of time subsequent to the
first period of time, the second alarm threshold replacing
the first alarm threshold,
[1(g)] wherein the second alarm threshold has a
value less than the at least one oxygen saturation value
and greater than a lower limit and at an offset from the at
least one oxygen saturation value, wherein the offset is
diminished as a difference between the at least first
oxygen saturation value and the lower limit diminishes;
[1(h)] determine oxygen saturation values of the
patient over the second period of time; and
[1(i)] trigger a second alarm based on at least one
value of the oxygen saturation values obtained over the
second period of time exceeding the second alarm
threshold.
Ex. 1001, 13:62–14:40. Claim 12 recites a method comprising steps
analogous to limitations 1(d)–1(i). See id. at 15:52–16:32.
Claim 8 is a system claim somewhat akin to claim 1. See id. at
15:1–39. Claim 8 differs from claim 1 most significantly in reciting that the
processor is configured to “apply a time delay based on the second alarm
threshold, wherein the time delay approaches zero as the at least one oxygen
saturation value obtained over the first period of time approaches the lower
limit.” Id. at 15:19–23.
D. Prior Art and Asserted Grounds
Petitioner asserts claims 1–10 and 12–18 are unpatentable, based on
the following two grounds. See Pet. 5–6.
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Claims Challenged 35 U.S.C. § References
1–4, 7, 12–15 103 Bock1, Kiani2
5, 6, 8–10, 16–18 103 Bock, Woehrle3, Kiani
E. Testimonial Evidence
Petitioner relies on the testimony of George E. Yanulis, D. Eng.
(Exhibit 1003) and Bryan Bergeron, M.D. (Exhibit 1040). Patent Owner
relies on the testimony of Jack Goldberg (Exhibit 2011).
III. ANALYSIS
A. Statement of Law
Petitioner bears the burden of proving unpatentability of the
challenged claims, and the burden of persuasion never shifts to Patent
Owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375,
1378 (Fed. Cir. 2015). To prevail, Petitioner must prove unpatentability by
a preponderance of the evidence. See 35 U.S.C. § 316(e); 37 C.F.R.
§ 42.1(d).
A patent claim is unpatentable under 35 U.S.C. § 103 if the
differences between the claimed subject matter 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

1 Ex. 1005, U.S. Patent No. 7,079,035 B2, issued July 18, 2006.
2 Ex. 1006, U.S. Patent No. 6,597,933 B2, issued July 22, 2003.
3 Ex. 1007, WO 2009/093159 A1, published July 30, 2009.
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(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, if made available in the record (which has not occurred
here). See Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
B. Level of Ordinary Skill in the Art, and
Patent Owner’s Related Challenge to Dr. Yanulis’s Testimony
1. Level of Ordinary Skill in the Art
Petitioner contends a person having ordinary skill in the art pertaining
to the ’218 patent (“POSITA”) “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.”
Pet. 9–10 (citing Ex. 1003 ¶¶ 33–40). Also: “Less work experience may be
compensated by a higher level of education, such as a master’s degree, and
vice versa.” Id.
Patent Owner “does not dispute Petitioner’s characterization of the
level of ordinary skill in the art,” which Patent Owner describes as
“[r]elatively [l]ow.” PO Resp. 12; Ex. 2011 ¶¶ 18–19.
We conclude the parties’ agreed-upon level of ordinary skill is
consistent with the ’218 patent and the asserted prior art. We, therefore,
apply it here.
2. Patent Owner’s Related Challenge to Dr. Yanulis’s Testimony
Patent Owner urges us to reject Dr. Yanulis’s testimony on behalf of
Petitioner concerning what a POSITA would have understood the prior art to
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disclose, and what a POSITA would have been motivated to do. See PO
Resp. 12–14. Patent Owner asserts Dr. Yanulis “admitted during his
deposition that he applied the wrong legal standard” because he “based his
opinions on how he personally interpreted the references, rather than what a
[POSITA] would have understood.” Id. at 12–13 (citing Ex. 2014,
55:11–18, 57:2–6, 136:8–9). Patent Owner explains: “This is problematic
because Petitioner asserts that Dr. Yanulis is an expert whose understanding
exceeds that of the ordinarily skilled artisan,” so his testimony as to
obviousness is based on “extraordinary skill and experience in the art” and
is therefore “irrelevant.” Id. at 13–14 (emphasis by Patent Owner) (citing
35 U.S.C. § 103; KSR, 550 U.S. at 420 (“The question is . . . whether the
combination was obvious to a person with ordinary skill in the art.”)).
Petitioner replies that Dr. Yanulis applied the correct legal standard,
because “he viewed the prior art and the [’218] patent from the perspective
of a [POSITA].” Pet. Reply 1–2 (citing Ex. 1003 ¶ 33). Petitioner asserts it
is not unusual for an expert witness such as Dr. Yanulis to have “credentials
additional to those of a [POSITA].” Id. (citing Ex. 1003 ¶¶ 4–12).
Petitioner does not discuss Dr. Yanulis’s deposition testimony.
Dr. Yanulis’s declaration states he has “knowledge relevant to what a
person having ordinary skill in the art at the time of the invention would
understand and do,” with the time of invention being “the priority date of the
[’218] patent” in 2010. Ex. 1003 ¶ 33. His declaration also states that in
2010 Dr. Yanulis “had 27 years of experience in this field and was a person
having ordinary skill in the art.” Id. Further, Dr. Yanulis concludes he is
“able to read and understand the claims and specifications of the prior art
and the [’218] patent in the light that a [POSITA] would read and understand
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them,” and sets forth the POSITA level we have adopted above. Id.
¶¶ 33–34. Thus, we agree with Petitioner that Dr. Yanulis’s declaration
indicates he applied the correct legal standard for obviousness, by testifying
as to what a POSITA would have known and done in 2010, rather than what
Dr. Yanulis personally would have known and done in 2010.
In the deposition testimony cited by Patent Owner, Dr. Yanulis was
asked “I think you mentioned in your declaration or elsewhere you have had
several decades of experience in this field. Is that right?” Ex. 2014,
55:11–16 (emphasis added). He responded: “I think that would be safe to
say. Probably more close to 40 years, counselor.” Id. at 55:17–18.
This testimony merely reflects Dr. Yanulis’s personal experience as
relevant to the ’218 patent, which qualifies him to testify concerning what a
POSITA would have known and done in 2010. Dr. Yanulis did not state that
his patentability opinions are premised on what he personally would have
known and done in 2010, rather than what a POSITA would have known
and done in 2010. See id. at 55:11–18.
Dr. Yanulis was later asked: “Would a person of ordinary skill in the
art have several decades of experience as of the priority date of
[the ’218] patent?” Id. at 56:12–14 (emphasis added). He answered: “Not
necessarily,” and further alluded to the POSITA description in his
declaration, which he recalled as being “at least a BS in biomedical
engineering or electrical engineering, and preferably a Master’s in either; as
well as at least two years of design experience and working with these
devices.” Id. at 56:15–57:1. He then added: “I wouldn’t expect a normal
[POSITA] to have that many years to completely understand what’s
disclosed, not only in the Bock patent, but in the prior art[.]” Id. at 57:2–6.
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We disagree with Patent Owner’s characterization of this testimony as
establishing that Dr. Yanulis’s patentability opinions are premised on what
he personally would have known and done in 2010. Instead, Dr. Yanulis
acknowledged that he personally had decades of experience in the pertinent
field, and then testified that such extensive experience (which is not required
for a POSITA) is not needed to understand Bock and the other prior art at
issue in this proceeding. See id. at 56:12–57:6. Thus, as with Dr. Yanulis’s
declaration, his deposition testimony was that he applied the correct legal
standard for obviousness, by testifying as to what a POSITA would have
known and done in 2010. This is confirmed by his later deposition
testimony: “I was referring to what I would expect a [POSITA] should know
reviewing this challenge[d] patent and the prior art,” and “I was just
reviewing based on my definition of a [POSITA]” even though “I think it’s
very fair to say I have more expertise than the typical [POSITA].” Id.
at 136:2–9 (emphases added).
Thus, after reviewing the entirety of Dr. Yanulis’s testimony cited by
the parties in this proceeding, we determine he applied the correct legal
standard for obviousness, by opining as to what a POSITA would have
known and done in 2010.
C. Claim Construction
We interpret the ’218 patent claims “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).” 37 C.F.R. § 42.100(b). This “includ[es]
construing the claim in accordance with the ordinary and customary
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meaning of such claim as understood by one of ordinary skill in the art and
the prosecution history pertaining to the patent.” Id.
We construe two aspects of claim 1, and then briefly address similar
limitations in claims 8 and 12.
1. Claim 1:
“at least one oxygen saturation value,”
“the at least one oxygen saturation value,” and
“the at least first oxygen saturation value”
Claim 1 recites, in limitation 1(e), “at least one oxygen saturation
value obtained over the first period of time,” wherein the value “exceeds a
first alarm threshold.” Ex. 1001, 14:6–8 (italicized emphasis added).
Limitation 1(g) adds “the second alarm threshold has a value less than the at
least one oxygen saturation value and greater than a lower limit and at an
offset from the at least one oxygen saturation value, wherein the offset is
diminished as a difference between the at least first oxygen saturation value
and the lower limit diminishes.” Id. at 14:16–30 (italicized and underlined
emphases added).
In the Institution Decision, we preliminarily construed these
limitations sua sponte. See Inst. Dec. 18–23. We also “encourage[d] both
parties to state in their post-institution briefs whether they agree with [our]
preliminary claim construction, and to discuss the reason(s) and support for
any disagreement.” Id. at 23. Patent Owner accepted this invitation. See
PO Resp. 29–30. Petitioner declined the invitation, until we sought
clarification during the oral hearing. See Pet. Reply 10; Tr. 11:13–14:18.
We now revisit our preliminary construction of these limitations, based on a
full record.
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First, focusing on limitation 1(g), we preliminarily concluded “the two
recitations of ‘the at least one oxygen saturation value,’ and the sole
recitation of ‘the at least first oxygen saturation value,’ all refer to the same
value as each other.” Inst. Dec. 21. Patent Owner agrees with this
preliminary construction. See PO Resp. 30. Petitioner has not taken a
position as to this preliminary construction. See, e.g., Pet. Reply 10. We,
therefore, discern no reason to deviate from this preliminary construction,
and we continue to maintain it here. See Inst. Dec. 21 (lines 4–18).
Second, considering the inter-relationship between limitations 1(e)
and 1(g), we preliminarily concluded that “the ‘one’ value in limitation 1(e)
[refers] to patient data generated by a sensor (such as parameter
segments 620, 630, and 640 in Figure 6 of the ’218 patent),” whereas “the
‘one’ or ‘first’ value in limitation 1(g) [refers] to a value derived from the
patient data (such as baselines B in Figure 6).” Inst. Dec. 23 (emphases
added); see also id. at 19–23 (analysis in support of preliminary
construction). Patent Owner disagrees, and contends the oxygen saturation
values recited in limitation 1(g) each “refer back to” the “same” oxygen
saturation value in limitation 1(e). PO Resp. 30 (emphasis added). This
value is patient data generated by a sensor, “not . . . a value derived from the
measured parameter values.” Id.
During the oral hearing, Petitioner’s counsel agreed with Patent
Owner’s construction of the inter-relationship between limitations 1(e)
and 1(g). See Tr. 8:15–9:5, 11:13–14:18. Petitioner’s counsel stated:
“I believe that our consistent position is that the value that’s being measured
from the patient at any given moment, that that is the oxygen saturation
value that we’re looking at” in both limitations. Id. at 12:23–13:1
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(emphases added). Thus, Petitioner’s position is that all of the oxygen
saturation values recited in limitations 1(e) and 1(g) refer to “measured
patient value[s],” not to other values derived from measured patient values.
Id. at 13:6–14:18. Patent Owner’s counsel confirmed Petitioner’s
description of claim 1 during the oral hearing is the same as Patent Owner’s
construction of claim 1. See id. at 31:20–32:17 (stating Patent Owner
“argue[s] . . . that all of the references to the value or the first value is
referring to the same thing, and so to the extent that that’s now what
[Petitioner] is arguing, then I guess we would agree with that”).
Upon review of the foregoing, and based on the agreement of the
parties in this regard, we construe all of the oxygen saturation values recited
in limitations 1(e) and 1(g) to refer to the same value. That is, they each
refer to patient data generated by a sensor, such as parameter segments 620,
630, and 640 in Figure 6 of the ’218 patent. The at least one value recited in
limitation 1(e) is obtained over a first period of time such as segment 620
over time t1. The at least one value recited in limitation 1(g) is obtained over
a second period of time, following the first period of time, such as
segment 630 over time t2. We do not construe the oxygen saturation values
recited in limitation 1(g) to refer to a value derived from the patient data,
such as baselines B.
2. Claim 1:
“one or more hardware processors configured to . . . trigger a second alarm
based on [a measured oxygen saturation value] exceeding the second alarm
threshold”
Limitation 1(i) recites a processor “configured to . . . trigger a second
alarm based on at least one value of the oxygen saturation values obtained
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over the second period of time exceeding the second alarm threshold.”
Ex. 1001, 14:1–3, 14:34–40 (emphases added).
a) The Institution Decision’s Preliminary Construction of Limitation 1(i)
In the Institution Decision, we preliminarily construed limitation 1(i)
sua sponte. See Inst. Dec. 18, 23–24. “[W]e conclude[d] that an oxygen
saturation value exceeding the second alarm threshold must be one condition
that is satisfied for the alarm to be ‘triggered . . . based on’ this condition in
limitation 1(i).” Id. at 24. We further concluded “claim 1 is open to
requiring additional conditions to be satisfied for the alarm to be triggered,”
with the ’218 patent disclosing a time delay condition as one example. Id.
at 23–24 (citing Ex. 1001, 2:54–3:1 (Fig. 1), 6:35–41 (Fig. 4A), 7:40–8:6
(Fig. 6), 14:58–62 (claim 5)).
This construction of limitation 1(i) was a significant factor in our
determination, at the institution stage, that Petitioner had sufficiently
established Bock discloses limitation 1(i) to justify institution of review,
over objections made in Patent Owner’s Preliminary Response. See id.
at 39–41.
b) Patent Owner’s Post-Institution Construction of Limitation 1(i)
Patent Owner argues the Institution Decision construed limitation 1(i)
too broadly, and pursuant to a correct and narrower claim construction, Bock
does not disclose limitation 1(i). See PO Resp. 2–3, 15–28.
Patent Owner asserts limitation 1(i) “requires that exceeding the
oxygen saturation value identified as the second alarm threshold triggers the
alarm (optionally in combination with other non-oxygen saturation value
conditions).” Id. at 15; Ex. 2011 ¶¶ 47–48. A time delay is one example of
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the other non-oxygen saturation value conditions permitted by this
construction. See PO Resp. 16, 26; Sur-reply 2; Ex. 2011 ¶ 48. The critical
difference between Patent Owner’s construction and the Institution
Decision’s preliminary construction is that, per Patent Owner, the other
conditions cannot be further oxygen saturation threshold values. See PO
Resp. 15, 18 (arguing limitation 1(i) “should not be construed to encompass
a system that triggers an alarm only if the patient’s oxygen saturation
exceeds a value that is more extreme than the purported ‘second alarm
threshold’” (emphasis added)); Ex. 2011 ¶¶ 47–53. Patent Owner’s
construction would differentiate claim 1 from Bock, because as discussed in
Section III.D.1 below, Bocks triggers an alarm only if the patient’s oxygen
saturation firstly exceeds tracking threshold 314—which Petitioner equates
to the second alarm threshold of limitation 1(i)—and then secondly exceeds
alarm limit 316. See PO Resp. 16–17, 20–21; Ex. 2011 ¶¶ 29–30, 36–37.
Concerning the claim language, Patent Owner argues the Institution
Decision “construed the phrase ‘triggered . . . based on . . . exceeding’ but
did not construe the phrase ‘second alarm threshold.’” PO Resp. 16, 18.
Patent Owner construes “second alarm threshold” to mean “the most
extreme (lowest) oxygen saturation value that must be exceeded to trigger
the second alarm.” Id. at 22; Sur-reply 3–4; Ex. 2011 ¶¶ 47–53. Patent
Owner’s view of the claim language is that “[i]f a purported condition
requires the oxygen saturation value exceed a value more extreme than the
alleged ‘second alarm threshold,’ it would not be adding a condition—it
would be eliminating and replacing it,” and further “[i]f exceeding an
oxygen saturation value cannot trigger an alarm, then that oxygen saturation
value cannot be the claimed ‘second alarm threshold.’” PO Resp. 17 (citing
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Ex. 2011 ¶¶ 47–48, 54–58, 63); id. at 18–19, 22–23; Sur-reply 2–3, 5 (citing
Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1288 n.10
(Fed. Cir. 2017), as indicating “it is ‘highly disfavored’ to construe claim
terms in a way that a phrase or limitation is rendered meaningless”). Patent
Owner cites dictionary definitions that “define ‘threshold’ using definite
articles” in support. PO Resp. 21 (citing Exs. 2012 and 2013); Ex. 2011
¶ 52.
Claim 5 depends from claim 1 to add that the processor “wait[s] for a
time delay prior to the triggering of the second alarm.” Ex. 1001, 14:58–62.
Patent Owner contends claim 5 does not justify the Institution Decision’s
preliminary construction. See PO Resp. 26–28; Ex. 2011 ¶¶ 54–64. Patent
Owner argues “[a] time-delay condition is distinct from an additional
oxygen saturation value-measurement condition,” so the addition of a time
delay is consistent with Patent Owner’s claim construction. PO Resp.
26–27; Ex. 2011 ¶¶ 61–62. Patent Owner asserts the Institution Decision’s
preliminary construction would improperly “subsume or obviate the oxygen
saturation value-measurement condition” in claim 1, rendering it
“meaningless,” based on the unrelated time delay condition in claim 5. PO
Resp. 26–27; Sur-reply 5–6; Ex. 2011 ¶¶ 61–62. Patent Owner provides a
Venn diagram to illustrate this contention. PO Resp. 27–28; Ex. 2011 ¶ 63.
Turning to the ’218 patent specification, Patent Owner asserts “each
description of ‘alarm threshold’ . . . refers to the most extreme value that
must be exceeded to trigger the alarm.” PO Resp. 19; Ex. 2011 ¶¶ 49–51,
59–61. Patent Owner cites several specification descriptions of alarm
thresholds, including the adaptive alarm threshold AT, as supporting this
assertion. PO Resp. 19–20 (citing Ex. 1001, Figs. 1 and 6, 2:58–62,
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3:10–23, 3:40–42, 4:43–47, 5:5–7, 6:35–38, 7:53–8:6, 11:18–25). Patent
Owner also asserts the ’218 patent’s usage of the claim phrase “based on”
and the similar phrase “based upon” is consistent with and confirms Patent
Owner’s proposed construction of limitation 1(i). Id. at 23–24 (citing
Ex. 1001, code (57), 5:5–7); Sur-reply 6; Ex. 2011 ¶¶ 59–60. Patent Owner
cites Wisconsin Alumni Research Foundation v. Apple Inc., 905 F.3d 1341,
1351–52 (Fed. Cir. 2018), as “rejecting a proposed construction that would
improperly ‘expand the scope of the claims far beyond anything described in
the specification.’” PO Resp. 26.
Patent Owner additionally contends Petitioner’s witness Dr. Yanulis
agrees with Patent Owner’s claim construction. See id. at 21–22 (citing
Ex. 1003 ¶¶ 26–27); id. at 24–25 (citing Ex. 2014, 192:3–9); Sur-reply 4–5.
c) Petitioner’s Post-Institution Construction of Limitation 1(i)
Petitioner agrees with the Institution Decision’s preliminary
construction of limitation 1(i). See Pet. Reply 2–10. Thus, Petitioner
contends this limitation should be construed to mean “exceeding the second
alarm threshold is at least one condition required to trigger an alarm.” Id.
at 3.
Considering the claim language, Petitioner argues Patent Owner’s
construction “is improperly restrictive.” Id. at 3, 8. According to Petitioner,
“construing claim language to exclude elements is disfavored in the absence
of support ‘in the words of the claim’ or through an ‘express disclaimer or
independent lexicography in the written description that would justify
adding that negative limitation.’” Id. at 3 n.1 (citing Omega Eng’g, Inc. v.
Rayteck Corp., 334 F.3d 1314, 1323 (Fed. Cir. 2003)). Petitioner argues the
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claim phrase “based on” imparts a breadth to claim 1 that belies Patent
Owner’s position. Id. at 3–4 (“Had the patentee intended the alarm to be
triggered by a narrower set of conditions, it could have so stated[.]”);
Ex. 1040 ¶¶ 51–53. Petitioner cites a dictionary definition of the term “base
on” as meaning “to use particular ideas or facts” (plural) to make a decision,
as “refut[ing] Patent Owner’s position that ‘based on’ means that other
oxygen saturation conditions cannot be included.” Pet. Reply 5 (citing
Ex. 1043); Ex. 1040 ¶ 52. Petitioner cites two District Court decisions that,
Petitioner asserts, construed the claim phrase “based on” to be “an
open-ended term.” Pet. Reply 6–7 (citing Intellectual Ventures II LLC v.
Sprint Spectrum L.P., No. 2:17-cv-662-JTG-RSP, 2018 WL 6018625, at *16
(E.D. Tex. Nov. 16, 2018); Apple Inc. v. Motorola, Inc., No. 1:11-cv-08540,
2012 WL 12537293, at *9 (N.D. Ill. Mar. 19, 2012)).
Considering the ’218 patent specification, Petitioner asserts the
patent’s usage of the term “based on” supports Petitioner’s construction.
Pet. Reply 5 (citing Ex. 1001, code (57)); Ex. 1040 ¶ 51. Also according to
Petitioner, the ’218 patent’s disclosure that “the alarm is triggered after
falling below the adaptive threshold and remaining below the adaptive
threshold after a time delay” further supports Petitioner’s construction. Pet.
Reply 4–6 (emphasis by Petitioner) (citing Ex. 1001, 6:35–44, 9:12–20,
11:18–32, claims 5–6); Ex. 1040 ¶¶ 54–57.
Petitioner further asserts “the result of [Patent Owner’s] proposed
construction is nonsensical,” because it would defeat the ’218 patent’s
purpose of addressing non-actionable alarms. Pet. Reply 8. Petitioner
reasons that, when a time delay is implemented as expressly contemplated in
the ’218 patent, and after the time delay period begins at the moment the
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patient’s measured oxygen saturation value exceeds an alarm threshold,
“common sense dictates that the system rechecks the patient’s oxygen
saturation” during the time delay period. Id. at 8–9 (emphasis by Petitioner);
Ex. 1040 ¶¶ 54–55. Otherwise, according to Petitioner, “[i]f the alarm
simply triggered at the end of the delay without rechecking oxygen
saturation values” per Patent Owner’s construction, “then the purpose of the
delay is entirely defeated” because “nuisance alarms would not be
prevented.” Pet. Reply 9 (emphasis by Petitioner); Ex. 1040 ¶¶ 56–57.
Petitioner finally argues that Patent Owner’s Venn diagram analysis is
not persuasive, because the referenced “Other Condition” (see PO Resp. 28,
green circle) is not identified or discussed in the record. See Pet. Reply 8
n.2. Petitioner concludes it is therefore “unclear what non-time delay and
non-oxygen saturation value conditions [Patent Owner] proposes would
satisfy its claim construction proposal.” Id.
d) Patent Owner’s Sur-reply as to Construction of Limitation 1(i)
Patent Owner replies that its proffered claim construction is not
nonsensical. Sur-reply 4. In particular: “Nothing in [Patent Owner’s]
construction excludes verifying or ‘rechecking’ that the oxygen saturation
exceeds the same ‘second alarm threshold.’” Id. (emphasis added). The
only exclusion from claim 1 proposed by Patent Owner is “exceeding a
value more extreme than the ‘second alarm threshold’ to trigger the alarm.”
Id.
Patent Owner also argues that the dictionary definition of “base on”
proffered by Petitioner supports Patent Owner’s claim construction. See id.
at 7. In Patent Owner’s view, the definition “emphasizes that a decision
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must be based on a ‘particular’ fact or facts,” and limitation 1(i)
correspondingly “recites that the particular fact is exceeding the ‘second
alarm threshold.’” Id.
Patent Owner asserts the two District Court decisions cited by
Petitioner do not support Petitioner’s position. See id. at 7–8. According to
Patent Owner, these decisions “stand for the unremarkable proposition that
using ‘based on’ and an open-ended transition ‘comprising’ does not exclude
systems that also use an additional independent condition,” and “[n]either
case suggested a construction encompassing a system that replaced the
claimed condition with some other more extreme condition.” Id.
e) Analysis and Conclusion as to Construction of Limitation 1(i)
(i) Language of Claim 1
We begin our claim construction with the claim language, which
recites “one or more hardware processors configured to . . . trigger a second
alarm based on at least one value of the oxygen saturation values obtained
over the second period of time exceeding the second alarm threshold.”
Ex. 1001, 14:1–3, 14:34–40 (emphases added).
This claim language does not support Patent Owner’s position that the
recited “second alarm threshold” must be the most extreme alarm threshold
that the processor determines has been exceeded by the measured oxygen
saturation values to trigger the alarm. Instead, the operative verbiage is that
the processor is “configured to . . . trigger a second alarm based on” the
measured oxygen saturation values exceeding the second alarm threshold.
The phrase “based on” requires that the processor must determine the
measured oxygen saturation values exceed the second alarm threshold, as a
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necessary condition precedent to the processor triggering the alarm. See,
e.g., Ex. 1043, 3 (defining the verb “base on” to mean “to use particular . . .
facts to make a decision [or] do a calculation”).
The claim language does not exclude the processor from additionally
determining that the measured oxygen saturation values further exceed a
more extreme (i.e., lower) alarm threshold, as a second necessary condition
precedent to the processor triggering the alarm, as Patent Owner would
construe the claim. Patent Owner’s construction would re-write
limitation 1(i) to recite something akin to “trigger[ing] a second alarm based
on at least one value of the oxygen saturation values obtained over the
second period of time exceeding the second alarm threshold, and no other
more extreme threshold,” which the claim does not recite.
Patent Owner’s claim construction relies too heavily on the plain
claim term “threshold.” This term reflects that the processor must determine
the measured oxygen saturation values exceed the second alarm threshold as
a necessary condition precedent to the processor triggering the alarm. But, it
does no more than that. Patent Owner cites dictionary definitions of the
term “threshold” as meaning “the magnitude or intensity that must be
exceeded for a certain reaction, phenomenon, result, or condition to occur or
be manifested,” and “[t]he point that must be exceeded to begin producing a
given effect or result or to elicit a response.” Exs. 2012 & 2013; PO
Resp. 21. Patent Owner emphasizes that both definitions begin with the
definite article “the,” and argues this indicates “a ‘threshold’ does not
encompass other values that may also be exceeded along the way” to a most
extreme threshold. PO Resp. 21 (emphasis added); Ex. 2011 ¶ 52.
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But, this is not what our claim construction does, because it
recognizes that the processor must determine that the measured oxygen
saturation values exceed the second alarm threshold. This comports with
Patent Owner’s dictionary definitions, and gives appropriate weight to the
term “threshold.” Patent Owner’s gloss on the plain term “threshold” as
meaning that no further thresholds may be implemented, despite the
open-ended claim term “comprising” (Ex. 1001, 13:63), is not persuasive.
Next, claim 5 depends from claim 1 to add that the processor is
“further configured to wait for a time delay prior to the triggering of the
second alarm.” Ex. 1001, 14:58–62 (emphasis added); see also id. at
6:38–41 (stating “the alarm . . . is triggered after a time delay (TD), which
may be fixed or variable” (emphasis added)); id. at Fig. 1, 2:54–3:1
(showing and discussing delay alarm threshold DL of a prior art alarm
system, which applies time delay TD). Patent Owner accepts, based on
claim 5 and the corresponding disclosures in the ’218 patent, that claim 1 is
open to the processor applying additional conditions—that is, further to the
measured oxygen saturation values exceeding the second alarm threshold—
being required to trigger an alarm. See PO Resp. 15, 16, 26. Patent Owner
nonetheless insists that these additional conditions cannot be further oxygen
saturation value thresholds. See id.; Ex. 2011 ¶¶ 47–53.
However, Patent Owner’s contention is not supported by the claim
language. There is nothing in claim 1 or in claim 5 that excludes the
processor from applying further oxygen saturation value thresholds, so long
as the processor must determine that the measured oxygen saturation values
exceed the second alarm threshold as a necessary condition precedent to
triggering the alarm. Based on claim 5, claim 1 is open to the processor
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applying additional conditions, such as a time delay, for the alarm to be
triggered. We discern nothing in claim 1 that limits the scope of the claim
such that these other conditions cannot include an additional, more extreme
oxygen saturation threshold also being applied by the processor.
Our construction does not eliminate, replace, or otherwise render the
second alarm threshold meaningless, as Patent Owner has suggested.
Instead, we recognize that the processor must determine that the measured
oxygen saturation values exceed the second alarm threshold as a necessary
condition precedent to triggering the alarm, even if an additional more
extreme oxygen saturation threshold determination is also required.
(ii) ’218 Patent Specification
Turning to the ’218 patent specification, it is undisputed that the
“second alarm threshold” of claim 1 corresponds to the adaptive
threshold AT illustrated in Figure 6. See Ex. 1001, 6:35–38, 7:40–8:6.
Further, Patent Owner is correct that the ’218 patent does not disclose any
embodiment in which the processor must determine the measured oxygen
saturation values 620, 630, or 640 further exceed an additional and more
extreme (i.e., lower) alarm threshold than alarm threshold AT to trigger an
alarm. See id. at 4:15–18, 4:46–47, 5:5–7, 6:35–38 (Fig. 4A), 7:53–8:6
(Fig. 6). The same is true of the fixed alarm thresholds DL and NDL of the
prior art system illustrated in Figure 1 of the ’218 patent. See id. at
2:54–3:6, 3:32–34, 3:40–42.
Nonetheless, while our claim interpretation cannot be divorced from
the ’218 patent specification and the record evidence, see Microsoft Corp. v.
Proxyconn, Inc., 789 F.3d 1292, 1298 (Fed. Cir. 2015) (quoting In re NTP,
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Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011)), we must be careful not to
import limitations from the specification that are not part of the claim
language. See SuperGuide Corp. v. DirecTV Enters., Inc., 358 F.3d 870,
875 (Fed. Cir. 2004) (“The written description, however, is not a substitute
for, nor can it be used to rewrite, the chosen claim language,” and
“a particular embodiment appearing in the written description may not be
read into a claim when the claim language is broader than the embodiment.”
(citations omitted)). Thus, the Federal Circuit “has emphasized that the
disclosure in the written description of a single embodiment does not limit
the claimed invention to the features described in the disclosed
embodiment,” absent a clear intention to limit claim scope by using words of
manifest exclusion or restriction. Gemstar-TV Guide Int’l Inc. v. Int’l Trade
Comm’n, 383 F.3d 1352, 1366 (Fed. Cir. 2004) (citations omitted). Any
special definition for a claim term must be set forth in the specification with
reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d
1475, 1480 (Fed. Cir. 1994).
As discussed above, the language of claim 1 is broader than the single
embodiment disclosed in the ’218 patent specification. Adopting Patent
Owner’s claim construction would improperly import a limitation from the
specification into claim 1. The verbiage of limitation 1(i) does not exclude
the processor from applying additional and more extreme (i.e., lower) alarm
thresholds, so long as the processor must determine that the measured
oxygen saturation values exceed the second alarm threshold as a necessary
condition precedent to triggering the alarm.
Patent Owner suggests our construction is overbroad, because it
means that every oxygen saturation value that is passed along the way to the
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most extreme alarm threshold is an “alarm threshold.” See PO Resp. 24–25,
37–39; Tr. 28:10–29:4. We disagree. It is, of course, true that for measured
values to reach any threshold—whether the single threshold of Patent
Owner’s construction, or the multiple thresholds of our construction—the
measured values must pass through a domain of values leading to the
threshold. For example, Figure 6 of the ’218 patent illustrates that the
downward trend of transient 624 in parameter segment 620 must pass
through the entire range of values from Max down to adaptive
threshold AT 628 to trigger an alarm by exceeding the adaptive threshold.
See Ex. 1001, Fig. 6, 7:53–58.
Thus, the ’218 patent states “a transient 624 having a size less than
Δ 626 does not trigger the alarm 412.” Id. at 7:56–58 (emphasis added).
This just means that, in the embodiment of Figure 6, the only threshold
applied by the processor is adaptive threshold AT. See id. at 7:53–8:6. That
is, in this embodiment, the only alarm-triggering oxygen saturation
determination made by the processor is whether parameter segment 620,
630, or 640 exceeds its corresponding adaptive threshold AT 628, 638,
or 648. Although the measured values must pass through a range of values
leading down to the adaptive threshold AT to reach and then exceed the
threshold, which is a matter of fact that applies to any threshold, still the
processor does not determine whether parameter segment 620, 630, or 640
exceeds any one value within the range along the way. Therefore, there is
no “threshold” applied above adaptive threshold AT, in the embodiment of
Figure 6. But, as discussed above, this disclosure of a single embodiment is
not inconsistent with the broad language of claim 1 covering other
embodiments, in which the processor triggers an alarm based on multiple
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threshold-exceeding determinations rather than the single
threshold-exceeding determination of Figure 6.
(iii) ’218 Patent Prosecution History
Patent Owner does not rely, in its briefs, on the ’218 patent
prosecution history to support its claim construction. See PO Resp. 15–28;
Sur-reply 2–8; Ex. 2011 ¶¶ 53, 64.
Petitioner’s Reply argues Patent Owner’s claim construction “ignores
the very amendments that [Patent Owner] was required to make in order to
obtain allowance” of the ’218 patent. Pet. Reply 1. The Reply particularly
asserts “the original claims” demonstrate Patent Owner could have claimed
the “narrower set of conditions” for triggering an alarm that Patent Owner
now seeks to incorporate into claim 1 via an improperly narrow claim
construction. Id. at 4. The Reply indicates the details are “discussed below”
(id.), but the Reply does not compare the original limitation 1(i) to the final
limitation 1(i) set forth in the ’218 patent. See id. at 4–10.
Petitioner provided the comparison during the oral hearing. See
Tr. 10:9–11:12, 15:3–4; Paper 32 (slides 8 & 13). Patent Owner objected to
this as improperly presenting new argument during the hearing (see
Tr. 26:21–25), and also argued the amendments to limitation 1(i) during
prosecution of the ’218 patent did not materially change the scope of the
claim as it applies to Bock (see id. at 26:26–28:5; Ex. 2016 (slides 11
& 13)). Petitioner responded that its oral hearing argument was presented
timely, because it responded to the claim construction position taken in the
Patent Owner Response. See Tr. 33:21–34:5.
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We conclude Petitioner’s oral hearing argument did not expand
improperly on arguments made in the Reply in response to Patent Owner’s
claim construction. The Reply expressly refers to changes made to “the
original claims” during prosecution of the ’218 patent, even though the
specific changes were not identified in the Reply. See Pet. Reply 4. The
application that became the ’218 patent was for a reissue of U.S. Patent
No. 9,775,570 B2 (“the ’570 patent”). See Ex. 1001, code (64); Ex. 1014
(the ’570 patent). Because limitation 1(i) is the limitation at issue here,
Petitioner’s comparison of limitation 1(i) in the ’570 patent (Ex. 1014,
14:17–22) to limitation 1(i) in the ’218 patent (Ex. 1001, 14:34–40) was not
out of bounds.
However, we do not rely on the changes made to limitation 1(i) during
prosecution of the ’218 patent to support our claim construction. Petitioner
first suggests that, because the application that became the ’218 patent was
filed within 2 years of the ’570 patent being issued,4 limitation 1(i) was
necessarily broadened during prosecution. See Tr. 11:7–12 (“So it’s
necessarily more broad. We know that because it’s a broadening reissue.”).
We disagree. Although filing within this 2-year period permits an applicant
to enlarge the scope of the claims, it does not require it. See, e.g., 35 U.S.C.
§ 251(d) (“No reissued patent shall be granted enlarging the scope of the
claims of the original patent unless applied for within two years from the
grant of the original patent.”).

4 The ’570 patent issued on October 3, 2017, and the application that
became the ’218 patent was filed on January 26, 2018. See Ex. 1014,
code (45); Ex. 1001, code (22).
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Turning then to the amendments at issue, limitation 1(i) in the
’570 patent recites “one or more hardware processors configured to . . .
determine whether a second alarm should be triggered by determining if at
least one oxygen saturation value obtained during the second period of time
exceeds the second alarm threshold and triggering an alarm if it is
determined the second alarm should be triggered.” Ex. 1014, 13:51–53,
14:17–22 (emphasis added). Limitation 1(i) in the ’218 patent recites “one
or more hardware processors configured to . . . trigger a second alarm based
on at least one value of the oxygen saturation values obtained over the
second period of time exceeding the second alarm threshold.” Ex. 1001,
14:1–3, 14:34–40 (emphases added).
It might be, as Petitioner contends, that the original version of
limitation 1(i) is limited in the way that Patent Owner now proposes we
should construe the reissued version of limitation 1(i), and the reissued
version is not so limited. However, Petitioner does not identify any action
taken or any representations made during prosecution of the ’218 patent to
indicate limitation 1(i) was construed in this specific fashion. See, e.g.,
Pet. Reply 1, 4. Therefore, the prosecution history has little impact on our
decision as to the scope of the reissued version of limitation 1(i). The issue
we must decide here is the scope of claim 1 in the ’218 patent, not the scope
of claim 1 in the ’570 patent. Comparing the two versions of limitation 1(i)
is an academic exercise that does not help us resolve this case. We therefore
do not assess the parties’ competing comparisons. See, e.g., Tr. 10:9–11:12,
15:3–4, 26:21–28:5; Paper 32 (slides 8 & 13); Ex. 2016 (slides 11 & 13).
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(iv) Extrinsic Evidence
We are not persuaded by Patent Owner’s contention that Petitioner’s
witness Dr. Yanulis agrees with Patent Owner’s claim construction.
Dr. Yanulis pertinently provides an “OVERVIEW” of the ’218 patent. See
Ex. 1003, pg. 7 (Title IV), ¶¶ 20–30. As part of this overview, Dr. Yanulis
states the “claims are directed to a system” including a processor that
“triggers an alarm if a second SpO2 measurement falls below the second
threshold.” Id. ¶ 26 (emphases added). Dr. Yanulis also states dependent
claim 5 “add[s] in the concept of introducing a time delay into the second
alarm threshold,” wherein “if an SpO2 measurement exceeds an alarm
threshold, the SpO2 measurement must remain below the threshold for a
predetermined amount of time before an alarm is generated.” Id. ¶ 27
(emphasis added). According to Patent Owner, these “statements that the
alarm is triggered ‘if’ the oxygen saturation level falls below the second
alarm threshold (or remains below for an amount of time) confirms there
cannot be an even lower value that must be exceeded to trigger the alarm.”
PO Resp. 21–22 (emphasis added).
We disagree, for at least two reasons. First, Dr. Yanulis’s statements
provided an overview of the ’218 patent including its claims, not a rigorous
claim construction analysis. See Ex. 1003, pg. 7 (Title IV), ¶¶ 42–43. For
example, he does not address the verbiage of limitation 1(i) in a claim
construction context. See id. ¶¶ 26–27.
Second, Dr. Yanulis’s testimony is not inconsistent with our
construction of claim 1, even if it is re-cast to the verbiage used in claim 1.
Specifically, describing an alarm as being triggered “if” the measured
oxygen saturation values exceed an alarm threshold is consistent with our
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construction that the processor must determine the measured oxygen
saturation values exceed the second alarm threshold as a necessary condition
precedent to triggering the alarm.
Patent Owner further relies on Dr. Yanulis’s deposition testimony
concerning Bock’s disclosure, as confirming Patent Owner’s claim
construction. Here, Dr. Yanulis was asked: “Is it correct that in Figure 2,
Bock does not disclose triggering the alarm based on the acquired data
merely exceeding heart rate value of 150?” Ex. 2014, 192:3–6. He
answered: “That would -- I would agree with that. It has to get to a certain
value before you are triggering the alarm.” Id. at 192:7–9. According to
Patent Owner, this testimony confirms the Institution Decision’s preliminary
construction is overbroad and Patent Owner’s narrower construction is
correct, because in Bock’s Figure 2 the heart rate value of 150 “is
necessarily exceeded . . . before and during the triggering of the alarm.” PO
Resp. 25; Sur-reply 4–5.
As already discussed in Section III.C.2(e)(ii) above, the measured
oxygen saturation values must pass through a domain of values leading to a
threshold in order to trigger an alarm based on exceeding the threshold,
regardless of whether a single threshold is applied per Patent Owner’s
construction or multiple thresholds are applied per our construction. In
referring to the measurements needing “to get to a certain value before you
are triggering the alarm,” Dr. Yanulis merely acknowledged that the
threshold must be reached. He did not agree with Patent Owner’s
construction that would require the second alarm threshold of claim 1 to be
the most extreme threshold applied by the processor.
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(v) Construction of Limitation 1(i)
We construe limitation 1(i) to require that the processor must
determine that the measured oxygen saturation values exceed the second
alarm threshold as a necessary condition precedent to triggering the alarm.
However, the second alarm threshold need not be the most extreme alarm
threshold applied by the processor. Claim 1 is open to additional alarm
thresholds also being applied by the processor, which are more extreme than
the second alarm threshold, so long as the second alarm threshold
determination is made by the processor.
3. Claims 8 and 12
Independent claims 8 and 12 each contain limitations that are
substantially identical to limitation 1(i) in claim 1. See Ex. 1001, 15:28–33
(claim 8), 16:26–32 (claim 12). Patent Owner argues we “should apply the
construction of [l]imitation 1(i)” to these limitations in claims 8 and 12. PO
Resp. 28–29; Ex. 2011 ¶ 65. We agree. Therefore, we construe these
limitations in the same fashion as limitation 1(i). See supra
Section III.C.2(e)(v).
4. Other Claim Terms
We determine no further explicit construction of any claim term is
needed to resolve the issues presented by the arguments and evidence. See
Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013,
1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “only
to the extent necessary to resolve the controversy” (quoting Vivid Techs.,
Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).
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D. Obviousness over Bock and Kiani
Petitioner asserts claims 1–4, 7, and 12–15 of the ’218 patent are
unpatentable as having been obvious over Bock and Kiani. Pet. 21–43.
Patent Owner opposes. PO Resp. 30–42. We have reviewed Petitioner’s
and Patent Owner’s arguments, and the evidence of record. We conclude a
preponderance of the evidence supports Petitioner’s assertions as to all
challenged claims 1–4, 7, and 12–15. We begin our analysis with brief
summaries of Bock and Kiani, then we address the parties’ contentions as to
obviousness.
1. Bock Disclosure
Bock discloses a system and method for monitoring a patient’s
physiological characteristics, and “dynamically adjusting an alarm limit
based on” the monitored data. Ex. 1005, code (57), 1:50–64, 5:8–13.
Excerpts from Figures 1 and 4 of Bock are reproduced here:
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Figures 1 and 4 illustrate data acquisition device or sensor 13, which
acquires physiological data such as heart rate or blood oxygen saturation
(SpO2) from patient 10, and transmits the acquired data to monitor 14 to be
illustrated on display 29. Id. at 3:30, 5:3–21. Monitor 14 includes
processor 27, which analyzes the acquired data to implement Bock’s alarm
scheme, by initiating alarm 31 pursuant to the scheme. Id. at 3:3–40,
9:9–11.
Figure 2 of Bock illustrates Bock’s alarm scheme, and is reproduced
here.
Figure 2 “is an illustration of alarm limits as alarm criteria where the limits
are dynamically adjusted,” in the context of monitoring a patient’s heart rate
(vertical axis) over time (horizontal axis). Id. at 2:47–49, 3:41–45.
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Acquired data stream 312 reflects the patient’s physiological data as
acquired by Bock’s sensor 13. Id. at 3:41–47, 5:8–13.
Extremity limit 308 represents an extreme lower value for the
monitored characteristic, requiring immediate attention if it is exceeded by
acquired data stream 312, so Bock’s processor 27 generates an immediate
alarm when this occurs. Id. at 3:50–58, 6:7–15 (describing Fig. 5,
blocks 104 and 106).
Calculated representative value 310 is generated by Bock’s
processor 27 based on acquired data stream 312, and “represents a typical
value for the patient for the characteristic being monitored” over time. Id.
at 1:52–57, 3:46–47, 3:59–4:3, 5:55–6:6 (describing Fig. 5, block 102),
7:4–33 (describing Fig. 5, block 116).
Lower tracking threshold 314 “is set based on calculated
representative value 310,” for example threshold 314 can be a pre-set
percentage difference less than calculated representative value 310. Id.
at 4:4–7, Fig. 2. In use: “Alarm limit 316 is set when acquired data 312
crosses tracking threshold 314.” Id. at 4:15–16, Fig. 2; id. at 6:20–23,
6:43–54 (describing Fig. 5, blocks 110 and 112). The initial value of alarm
limit 316 “can be based on calculated representative value 310, tracking
threshold 314, and/or any other value,” and then alarm limit 316 decreases
over time as shown in Figure 2 between minutes 21.5 and 24.5. Id. at
4:17–25. “Once alarm limit 316 is set, if acquired data 312 crosses alarm
limit 316 an alarm is generated as represented by bar 318” in Figure 2
between minutes 22 and 22.8, and again at about minute 23.3 and about
minute 24. Id. at 4:26–30; id. at 6:43–45, 6:64–65 (describing Fig. 5,
blocks 112 and 106).
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2. Kiani Disclosure
Kiani discloses: “A pulse oximetry system [that] consists of a sensor
attached to a patient, a monitor, and a cable connecting the sensor and
monitor.” Ex. 1006, 1:19–21. The sensor is attached to a patient’s finger,
and includes emitters that emit red and infrared light through a patient’s
fingernail and into the blood vessels and capillaries, as well as a photodiode
detector that detects the emitted light as it emerges from the finger tissue.
Id. at 1:22–30. The monitor analyzes the data to determine oxygen
saturation in the patient’s blood. Id. at 1:31–43.
3. Claim 1
Petitioner provides arguments and evidence, including testimony from
Dr. Yanulis and Dr. Bergeron, in support of contending claim 1 is
unpatentable as having been obvious over Bock and Kiani. Pet. 21–38; Pet.
Reply 10–14; Ex. 1003 ¶¶ 71–115; Ex. 1040 ¶¶ 58–59, 61–75. Patent
Owner provides arguments and evidence in opposition, including testimony
from Mr. Goldberg. PO Resp. 30–41; Ex. 2011 ¶¶ 27–40, 67–80.
a) [1(a)] 1. A system for reducing electronic alarms in a medical patient
monitoring system, the system comprising:

[1(b)] an optical sensor configured to transmit optical radiation into a
tissue site of a patient and detect attenuated optical radiation indicative of at
least one physiological parameter of a patient
Petitioner addresses claim 1’s preamble 1(a) and limitation 1(b) by
contending Bock’s patient monitor 14 reduces alarms when monitoring a
patient, and Bock’s sensor 13 monitors the patient to generate data indicative
of a physiological parameter of the patient, i.e., oxygen saturation. See
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Pet. 12, 21–23 (citing Ex. 1005, code (57), 1:8–20, 5:3–16, Fig. 4); Ex. 1003
¶¶ 44–46, 73–76. Petitioner concedes Bock’s sensor 13 is not expressly
disclosed to be an “optical” sensor, as is required by limitation 1(b). See
Pet. 21, 24; Ex. 1003 ¶¶ 71–72, 77, 80.
Patent Owner does not challenge these contentions, and we determine
they are supported by a preponderance of the evidence cited by Petitioner.
See, e.g., Ex. 1005, code (57), 1:8–20, 5:3–16 (Fig. 4); Ex. 1003 ¶¶ 44, 46,
74–77.
Petitioner next asserts Kiani discloses an optical sensor, which senses
oxygen saturation by transmitting and detecting optical radiation passing
through the patient’s tissue, as is required by limitation 1(b). See Pet. 17–18,
23–24 (citing Ex. 1006, 1:12–45); Ex. 1003 ¶¶ 53–56, 79. Petitioner further
asserts it was well known at the time the ’218 patent was filed that oxygen
saturation “was generally measured externally for a patient” using optical
sensors. Pet. 23 (citing Ex. 1003 ¶¶ 77–78; Ex. 1001, 1:39–55). Petitioner
asserts a person of ordinary skill in the art “would have been motivated to
substitute the optical sensor of Kiani for [Bock’s sensor,] because optical
sensors measure oxygen saturation and pulse rate non-invasively, which
provides more comfort to the patient and enables easy application and
removal of the sensor on a patient.” Id. at 24 (citing Ex. 1005, 1:8–20,
5:3–5; Ex. 1006, 1:17–19); Ex. 1003 ¶¶ 71–72, 77–81. This substitution, in
Petitioner’s view, “is a simple substitution of one known element for another
yielding predictable results.” Pet. 24; Ex. 1003 ¶¶ 80–81.
Patent Owner does not challenge these contentions, and we determine
they are supported by a preponderance of the evidence cited by Petitioner.
Specifically, Kiani discloses a sensor that emits optical radiation (i.e., red
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light) through an adult patient’s finger, and then detects the attenuated light,
to measure the patient’s blood oxygen saturation level. See Ex. 1006,
1:10–45. The summary nature of Kiani’s description of optical oxygen
saturation sensors, as the “BACKGROUND” to Kiani’s invention, suggests
this technology was well developed and well known at the time of Kiani’s
invention in July 2003—almost seven years before the ’218 patent’s
March 2010 earliest-possible priority date. See id.; id. at code (45);
Ex. 1001, code (60). The ’218 patent’s “BACKGROUND” section,
similarly, suggests optical oxygen saturation sensors were well developed
and well known at the time of the ’218 patent’s invention. Ex. 1001,
1:32–55. Dr. Yanulis’s testimony is to a similar effect. Ex. 1003 ¶¶ 36–37,
52, 54, 56, 77–79. Mr. Goldberg does not contest this testimony from
Dr. Yanulis. See, e.g., Ex. 2011 ¶¶ 66–80.
Further, Bock discloses its sensor 13 and monitor 14 may be used to
monitor a patient’s blood oxygen saturation (SpO2), but Bock does not
provide any details concerning how sensor 13 would do so. See Ex. 1005,
5:3–16 (Fig. 4). We agree with Petitioner’s contention that it would have
been obvious to use an optical oxygen saturation sensor in Bock’s system,
based on Kiani and the well developed status of such sensors at the time of
the ’218 patent’s invention, as a non-invasive measurement technique which
provides more comfort to the patient and enables easy application and
removal of the sensor on a patient. See Pet. 23–24; Ex. 1003 ¶¶ 77–81.
Thus, we determine Petitioner’s contentions as to the preamble 1(a) and
limitation 1(b) are supported by a preponderance of the evidence.
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b) [1(c)] one or more hardware processors in electronic communication
with the optical sensor, the one or more hardware processors configured
to: . . .
Petitioner contends Bock’s patient monitor 14 is in electronic
communication with the optical sensor of Bock and Kiani, in order to
receive physiological data from the sensor. See Pet. 25–26 (citing Ex. 1005,
Fig. 1, 3:31–39, 5:3–16); Ex. 1003 ¶¶ 82–83. Petitioner further contends
patient monitor 14 includes processor 27 which performs the data analyses
disclosed in Bock. See Pet. 26 (citing Ex. 1005, 3:31–39); Ex. 1003
¶¶ 82–83.
Patent Owner argues “Bock fails to disclose ‘one or more processors
configured’ to perform the claimed triggering.” PO Resp. 40 (section title
modified to lowercase letters). Patent Owner here quotes limitation 1(c) as
the limitation at issue, but then argues “Petitioner fails to demonstrate that
Bock discloses a ‘second alarm threshold’ . . . or ‘trigger[ing] a second
alarm based on [an oxygen saturation value] exceeding the second alarm
threshold[’]” as recited in limitation 1(i). Id. In other words, Patent Owner
does not dispute that Bock discloses a processor, or that Bock’s processor
implements an oxygen saturation level alarm scheme. See id. at 40–41.
Instead, Patent Owner’s objection is that the alarm scheme implemented by
Bock’s processor is different from the scheme required by limitation 1(i).
We address this argument below in Section III.D.3(h).
As to limitation 1(c), we find a preponderance of the evidence
supports Petitioner’s contention that Bock discloses one or more hardware
processors in electronic communication with an oxygen saturation sensor,
and configured to implement an alarm scheme based on the sensor readings.
In particular, Bock’s patient monitor 14 includes processor 27 in
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communication with sensor 13 which measures the oxygen saturation (SpO2)
of patient 10. See Ex. 1005, Figs. 1 and 4, 3:29–34, 5:3–16; Ex. 1003
¶¶ 82–83. Further, as we found in the Institution Decision, in Bock “the data
processing may be performed by processor 27 of monitor 14, or by another
processor 26 via a network connection to monitor 14.” Inst. Dec. 33 n.7
(citing Ex. 1005, Fig. 1, 3:31–39, 5:3–16). Patent Owner does not challenge
these findings. See, e.g., PO Resp. 40–41.
c) [1(d)] determine oxygen saturation values of the patient
over a first period of time
Petitioner contends Bock’s processor 27 determines oxygen saturation
values of the patient over a first period of time, which Petitioner equates to
minute 0 to minute 21 in Bock’s Figure 2. Pet. 26–27 (citing Ex. 1005,
5:3–16, 5:52–6:6); Ex. 1003 ¶¶ 84–86. Petitioner asserts these values appear
in Figure 2 as acquired data stream 312, which in Figure 2 are heart rate
values, but “the same concepts apply to [oxygen saturation] measurements”
when Bock’s system monitors oxygen saturation, as is disclosed in Bock.
Pet. 13, 26–27 (citing Ex. 1005, 5:10–13, 5:52–6:6); Ex. 1003 ¶¶ 46, 84–86.
Patent Owner does not challenge these contentions, and we determine
they are supported by a preponderance of the evidence cited by Petitioner.
See, e.g., Ex. 1005, 5:3–16 (Fig. 4), 5:52–6:6 (Fig. 5); Ex. 1003 ¶¶ 46,
84–86.
d) [1(e)] when at least one oxygen saturation value obtained over
the first period of time exceeds a first alarm threshold,
determine whether a first alarm should be triggered
We have construed the “one” oxygen saturation value in
limitation 1(e) to refer to one value of the patient data generated by a sensor
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during the first period of time. See supra Section III.C.1. Petitioner equates
this, in Bock, to one value of acquired data stream 312, during minute 0 to
minute 21 in Bock’s Figure 2. Pet. 27–28.
Petitioner particularly contends Bock’s processor 27 determines
whether acquired data stream 312 “exceeds the tracking threshold [314] and
alarm limit [316] . . . and, if so, an alarm is triggered,” as is shown in
Figure 5 at blocks 110, 112, and 106. Id. (citing Ex. 1005, 6:20–54,
6:64–7:3); id. at 13 & n.3 (“If the patient data [312] exceeds the
threshold [314] (this event is called an alarm limit 316), then an alarm is
triggered.”) (further citing Ex. 1005, 2:23–28, 4:4–28, 5:3–16); Ex. 1003
¶¶ 46–47, 49, 87–88. Petitioner contends that, while Figure 2 does not
illustrate the alarm being triggered during the first period of time from
minute 0 to minute 21, nonetheless acquired data stream 312 is monitored
during the first period of time, and an alarm would be triggered if the data
were to cross tracking threshold 314 and then alarm limit 316, as is shown in
Figure 2 “at the 22–24 minute mark.” Pet. 27–28; Ex. 1003 ¶¶ 87–88.
Patent Owner does not challenge these contentions, and we determine
they are supported by a preponderance of the evidence cited by Petitioner.
See, e.g., Ex. 1005, 2:23–28, 4:4–28 (Fig. 2), 6:20–54 (Fig. 5), 6:64–65;
Ex. 1003 ¶¶ 46–47, 49, 87–88.
e) [1(f)] access a second alarm threshold to be applied during a second
period of time subsequent to the first period of time, the second alarm
threshold replacing the first alarm threshold
Petitioner contends Bock’s processor 27 accesses a second alarm
threshold, which is tracking threshold 314, to be applied during a second
period of time, which includes minute 28 in Bock’s Figure 2. Pet. 14–15,
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28–31 (citing Ex. 1005, 3:40–48, 3:59–4:25, 7:4–26); Ex. 1003 ¶¶ 47,
89–96. Petitioner asserts Bock replaces the first alarm threshold, which is
tracking threshold 314 during the first period of time, with the second alarm
threshold, which is tracking threshold 314 during the second period of time,
because this is how a computer’s processor and memory operate. Pet. 28–30
(citing Ex. 1005, code (57), 3:31–40, 4:4–25, 7:19–26, 7:61–8:2, 8:25–27);
Ex. 1003 ¶¶ 89–91. In particular, according to Petitioner, “Bock teaches that
new tracking thresholds [314] are calculated based on the calculated
representative value 310,” which changes over time as acquired data
stream 312 changes. Pet. 29–31 (citing Ex. 1005, 3:31–40, 4:4–25, 7:19–26,
8:25–27); Ex. 1003 ¶¶ 92–93, 95–96.
Patent Owner does not challenge these contentions, and we determine
they are supported by a preponderance of the evidence cited by Petitioner.
See, e.g., Ex. 1005, code (57), 3:31–48 (Fig. 1), 3:59–4:25 (Fig. 2), 7:4–8:27
(Fig. 5); Ex. 1003 ¶¶ 47, 92–93, 95–96.
f) [1(g)] wherein the second alarm threshold has a value less than the at
least one oxygen saturation value and greater than a lower limit and at an
offset from the at least one oxygen saturation value, wherein the offset is
diminished as a difference between the at least first oxygen saturation value
and the lower limit diminishes
We have construed the “one” and the “first” oxygen saturation values
in limitation 1(g) to refer to the same value, which is one value of the patient
data generated by a sensor during the second period of time. See supra
Section III.C.1.
In the Institution Decision, we concluded “Petitioner appears to
equate” the oxygen saturation value in limitation 1(g) “to calculated
representative value 310, after minute 21 in Figure 2.” Inst. Dec. 36
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(emphasis added) (citing Pet. 31–37; Ex. 1003 ¶¶ 97–112). However, we
recognized “Petitioner’s analysis here lacks clarity, because it largely
abstains from analyzing the allegedly ‘long and wordy’ claim language in
favor of what Petitioner describes as the ‘[e]ssential[]’ ‘concept’ of
limitation 1(g).” Id. (citing Pet. 31; Ex. 1003 ¶¶ 97–99). In particular, we
concluded “[t]he Petition . . . refers repeatedly to a ‘measured parameter’ or
a ‘measured value’ in Bock, sometimes referencing acquired data
stream 312, and other times referencing calculated representative
value 310.” Id. (emphases added) (citing Pet. 31–37).
The post-institution briefing (the Patent Owner Response, the
Petitioner Reply, and the Patent Owner Sur-reply) does not address the
Petition’s reliance on Bock as disclosing limitation 1(g), or the Institution
Decision’s preliminary reading of the Petition in this regard.
When Petitioner’s counsel was questioned during the oral hearing
about Petitioner’s contentions in this regard, counsel stated: “I believe that
our consistent position is that the value that’s being measured from the
patient at any given moment” in Bock, “that that is the oxygen saturation
value that we’re looking at” as being the oxygen saturation value in
limitation 1(g). Tr. 12:23–13:5 (emphases added). Thus, Petitioner’s
position is that Bock’s “measured patient value” (i.e., acquired data
stream 312) corresponds to the oxygen saturation value identified in
limitation 1(g). Id. at 13:6–14:18.
Patent Owner’s counsel then argued: “[T]o the extent that
[Petitioner’s] initial analysis took a different approach and identified
different things in Bock [as satisfying limitation 1(g)], then I think there may
still be a deficiency in [Petitioner’s] grounds.” Id. at 31:20–32:25.
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However, Patent Owner’s counsel did not explain what the deficiency might
be, or identify any specific passage(s) in the Petition that would limit
Petitioner’s contentions to relying on Bock’s calculated representative
value 310 as the oxygen saturation value recited in limitation 1(g). See id.
Based on the entirety of the record, we now understand Petitioner
contends Bock’s acquired data stream 312, and not Bock’s calculated
representative value 310, corresponds to the oxygen saturation value in
limitation 1(g). Further, we understand Petitioner contends Bock’s tracking
threshold 314 is a second alarm threshold that is less than acquired data
stream 312, and is greater than a lower limit, which is lower extremity
limit 308. Pet. 33–35 (citing Ex. 1005, code (57), Figs. 2, 3, and 5, 1:25–31,
3:40–49, 4:4–25, 5:52–6:6, 7:4–26, 8:28–34, 9:28–37); Ex. 1003
¶¶ 101–105. Petitioner also contends Bock’s tracking threshold 314 is at an
offset from acquired data stream 312, because threshold 314 is set as a
percentage of calculated representative value 310, which is adjusted to
represent acquired data stream 312 over time. Pet. 34–35 (citing Ex. 1005,
3:40–49, 4:4–25, 7:4–26, 8:28–34, 9:28–37); Ex. 1003 ¶¶ 104–107.
According to Petitioner, based on this percentage relationship, it necessarily
follows that the offset is diminished as a difference between acquired data
stream 312 and lower extremity limit 308 diminishes. Pet. 16 & n.4; id.
at 32–33, 35; Ex. 1003 ¶¶ 50–51, 99–100, 104–107.
Patent Owner does not challenge these contentions, and we determine
they are supported by a preponderance of the evidence cited by Petitioner.5

5 Petitioner also argues Bock’s disclosure of “tightening” alarm criteria “is
the same concept as the claimed ‘diminishing’ threshold.” Pet. 36–37 (citing
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See, e.g., Ex. 1005, code (57), Figs. 2 and 5, 3:40–49, 4:4–25, 5:52–6:6,
7:4–26, 8:28–47; Ex. 1003 ¶¶ 50–51, 99–107.
g) [1(h)] determine oxygen saturation values of the patient over the
second period of time
Petitioner contends Bock’s processor 27 determines oxygen saturation
values of the patient over the second period of time, which (as discussed
above) is after minute 21 in Bock’s Figure 2. Pet. 37–38 (citing Ex. 1005,
1:32–44, 2:23–28, 5:3–16, 8:3–19); Ex. 1003 ¶ 113.
Patent Owner does not challenge this contention, and we determine it
is supported by a preponderance of the evidence cited by Petitioner. See,
e.g., Ex. 1005, 2:23–28, 5:3–16, 8:3–19; Ex. 1003 ¶ 113.
h) [1(i)] trigger a second alarm based on at least one value of the
oxygen saturation values obtained over the second period of time exceeding
the second alarm threshold
Petitioner contends Bock’s processor 27 triggers a second alarm based
on at least one oxygen saturation value obtained over the second period of
time exceeding the second alarm threshold. Pet. 38 (citing Ex. 1005, Fig. 5,
2:23–28, 5:3–16, 8:3–27); Ex. 1003 ¶ 114. As discussed above, Petitioner
equates the claimed second alarm threshold over a second period of time, in
Bock, to tracking threshold 314 after minute 21 in Figure 2.
Patent Owner firstly argues Petitioner errs in relying on Bock’s
tracking threshold 314 as the “second alarm threshold” of claim 1, because
threshold 314 is not the most extreme (lowest) oxygen saturation value that

Ex. 1005, Fig. 3, 1:19–44, 6:36–42, 6:55–63, 8:3–34, 9:28–34); Ex. 1003
¶¶ 109–111. We do not rely on this position as a basis for our present
Decision.
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must be exceeded to trigger an alarm, which instead is Bock’s alarm
limit 316. See PO Resp. 7–11, 30–34; Ex. 2011 ¶¶ 27–38, 68–74. This
argument is premised on Patent Owner’s construction of limitation 1(i),
which we have determined is not persuasive. See supra Section III.C.2.
Therefore, Patent Owner’s application of its claim construction to Bock also
is not persuasive.
We find Bock’s tracking threshold 314 is an “alarm threshold” as
recited in claim 1, because Bock’s processor 27 must determine acquired
data stream 312 exceeds (falls below) tracking threshold 314 as a necessary
condition precedent to triggering the alarm at alarm limit 316. See supra
Section III.C.2 (claim construction). Specifically, acquired data stream 312
falling below tracking threshold 314 “set[s]” alarm limit 316, to a value
which can be “based on” tracking threshold 314. Ex. 1005, 4:15–28, Fig. 2
(showing acquired data stream 312 crossing tracking threshold 314 at
minute 21.5, which sets alarm limit 316 at about 113 heart beats per minute,
and alarm limit 316 thereafter decreases over time). If acquired data
stream 312 does not fall below tracking threshold 314, then alarm limit 316
is not set, and alarm indicator 318 cannot be triggered by acquired data
stream 312 falling below alarm limit 316. Id.; see also id. at 6:43–47 (in
Figure 5, “[i]f the data [312] does cross the tracking threshold [314] at
block 110, a determination is made at block 112 as to whether the data meets
an alarm criteria [i.e. alarm limit 316] at block 112,” and “[t]he alarm
criteria of block 112 is preferably affected by the fact that the data [312]
crossed the tracking threshold [314] at block 110” (emphasis added)). In
this way, acquired data stream 312 falling below tracking threshold 314 is
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one necessary condition precedent that must be satisfied for alarm 318 to be
triggered at alarm limit 316.
Dr. Yanulis, Dr. Bergeron, and Mr. Goldberg all agree that this is how
Bock operates to trigger an alarm at alarm limit 316, based on data 312
firstly crossing threshold 314 to set limit 316. See Ex. 1003 ¶¶ 46–49,
87–88, 114; Ex. 2014, 158:12–163:14 (Dr. Yanulis correcting and clarifying
statements he made in Ex. 1003 ¶ 114); Ex. 1040 ¶¶ 62–64, 75; Ex. 2011
¶¶ 29–32, 35–37, 70–73.
This finding that Bock’s tracking threshold 314 is an “alarm
threshold” as recited in claim 1 means that we need not reach a few
alternative arguments presented by both parties. Thus, we do not reach
Petitioner’s arguments that Bock discloses alarm limit 316 may either: be set
equal to tracking threshold 314 in some circumstances; or decay to be equal
to tracking threshold 314 in other circumstances.6 See Pet. Reply 10–14;
Ex. 1040 ¶¶ 63–75. We also do not reach Patent Owner’s argument that
Petitioner does not and cannot “assert that any other value disclosed in Bock
is the claimed ‘second alarm threshold,’” such as Bock’s alarm limit 316.
See PO Resp. 33 (lines 5–19).

6 Petitioner has further disavowed any argument that it might have been
obvious to modify Bock to implement limitation 1(i), if it is not expressly
disclosed in Bock, unless we adopt Patent Owner’s claim construction. See
Pet. Reply 10–14 (“[S]hould the Board adopt [Patent Owner’s] proposed
constructions, Bock still renders the claims obvious.”); Tr. 17:20–18:16
(Petitioner’s counsel stated “the only modification that we argued with
respect to Bock in Ground 1 is the replacement of the sensor with the optical
sensor of Kiani,” and “[w]e are not arguing that the tracking threshold or the
alarm limit have to be modified”).
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Patent Owner secondly argues that, even if Bock’s tracking
threshold 314 is an “alarm threshold” as recited in claim 1, Bock does not
disclose triggering a second alarm based on an oxygen saturation value
exceeding tracking threshold 314 as is further claimed. See id. at 7–11,
34–40. In particular, according to Patent Owner, “Bock discloses that
exceeding tracking threshold 314 does not, alone or in combination with a
time delay, trigger an alarm,” because Bock’s alarm limit 316 must also be
exceeded to trigger an alarm. Id. at 34–36 (citing Ex. 1005, Fig. 5
(steps 110, 112, and 106), 6:20–24); Ex. 2011 ¶¶ 75–80.
These arguments are not persuasive, for reasons provided above.
They again rely on Patent Owner’s proffered claim construction, which is
not persuasive. See supra Section III.C.2 (claim construction). And, we
find that Bock’s processor 27 triggers an alarm based on acquired data
stream 312 falling below tracking threshold 314, because the processor must
first determine this event occurs before alarm limit 316 is set to cause the
triggering of an alarm when acquired data stream 312 exceeds limit 316.
Patent Owner thirdly contends that Dr. Yanulis admitted during his
deposition that his declaration was mistaken in stating that “Bock teaches the
processor trigger[s] an alarm anytime [an] oxygen saturation value[] exceeds
a threshold,” and “Bock teaches that if the data [312] dipped below the
tracking threshold 314 at a period of time subsequent to the 24 minute mark,
another alarm would be triggered.” Ex. 1003 ¶ 114; PO Resp. 36 (citing
Ex. 2014, 162:11–163:13). We agree that Dr. Yanulis admitted these two
sentences were mistaken. See Ex. 2014, 163:3–13.
However, in context, Dr. Yanulis testified that Bock’s processor 27
triggers an alarm based on acquired data stream 312 falling below tracking
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threshold 314, because the processor must first determine this event occurs
before alarm limit 316 is set to cause the triggering of an alarm when
acquired data stream 312 exceeds limit 316. See id. at 158:12–163:14. For
example, Dr. Yanulis stated: “The tracking threshold . . . is just one
condition for triggering the alarm, or if an alarm is triggered.” Id. at
159:1–3. Dr. Yanulis further acknowledged that Figure 2 of Bock does not
illustrate an alarm being triggered after minute 24, despite acquired data
stream 312 falling below tracking threshold 314 at minute 25, which causes
the processor to set a second alarm limit 316 that persists from minute 25 to
minute 27. Id. at 161:3–163:1. But, he added “[t]hat doesn’t mean another
alarm won’t eventually present itself as an event.” Id. at 161:15–16. Thus,
according to Dr. Yanulis, Bock’s system would have triggered an alarm
between minutes 25 and 27 if acquired data stream 312 had passed below the
second alarm limit 316 that was set when data 312 exceeded tracking
threshold 314 at minute 25, but because that second alarm condition did not
actually occur no alarm was triggered.
Patent Owner further asserts Dr. Yanulis agreed “that Bock does not
disclose triggering an alarm based on exceeding the tracking threshold” 314.
PO Resp. 37 (quoting Ex. 2014, 89:17–22). Patent Owner’s selective
quotation here of the deposition transcript at page 89, lines 17–22 omits the
introductory line 16, “I’m looking at minutes 25 to 27” (Ex. 2014, 89:16–
22). This cabined Dr. Yanulis’s statement to that portion of Bock’s Figure 2
where no alarm was triggered because acquired data stream 312 did not
exceed the second alarm limit 316 that was set when data 312 exceeded
tracking threshold 314 at minute 25. This does not change the fact that
Bock’s processor does not set any alarm limit 316 until the processor
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determines acquired data stream 312 falls below tracking threshold 314.
This fact establishes Bock’s processor triggers an alarm based on acquired
data stream 312 exceeding tracking threshold 314, as broadly recited in
claim 1, even though data 312 must additionally exceed the corresponding
alarm limit 316 for an alarm to be triggered.
i) Conclusion as to Claim 1
Based on the foregoing arguments and evidence, we conclude
Petitioner has demonstrated by a preponderance of the evidence that claim 1
is unpatentable as having been obvious over Bock and Kiani.
4. Claim 7
Claim 7 recites: “The system of claim 1, wherein the first alarm
threshold is predetermined.” Ex. 1001, 14:66–67 (emphasis added).
Petitioner contends “Bock teaches that the alarm threshold may be
predetermined.” Pet. 40. Petitioner cites Bock’s disclosure that: “The
tracking threshold [314] can be a preset amount different than the calculated
representative value [310].” Id. (quoting Ex. 1005, 6:23–24, and citing id.
at 6:20–42); Ex. 1003 ¶ 122.
Patent Owner argues Bock’s tracking threshold 314 is not
predetermined. See PO Resp. 41–42. Patent Owner asserts “Bock calculates
the representative value [310] after acquiring patient data [312],” which “is
not predetermining the tracking threshold [314].” Id. at 41 (emphasis added)
(citing Ex. 1005, 5:52–56); Ex. 2011 ¶ 82. To satisfy claim 7, Patent Owner
argues Bock must determine tracking threshold 314 “prior to acquiring
patient data.” PO Resp. 41 (emphasis added); Ex. 2011 ¶ 82.
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Petitioner replies that “claim 7 does not state when or how the
tracking threshold must be ‘predetermined.’” Pet. Reply 15. Petitioner
asserts Bock’s tracking threshold 314 “is predetermined because it is not a
diminishing or changing threshold, but one that is set at a difference from
the calculated representative value” 310, wherein the difference is
predetermined. Id. (citing Ex. 1005, 6:20–42; Ex. 1003 ¶ 122); Ex. 1040
¶ 77.
Patent Owner replies that, although Bock does calculate tracking
threshold 314 as a predetermined difference from calculated representative
value 310, threshold 314 is not predetermined as recited in claim 7 because
value 310 “changes over time” and threshold 314 changes with it.
Sur-reply 20 (citing Ex. 1005, Fig. 2).
Resolution of the parties’ dispute as to claim 7 turns on claim
construction. Specifically: Does the term “predetermined” require that the
alarm threshold value is determined prior to acquiring patient data (as Patent
Owner contends), or that the alarm threshold calculation is determined prior
to acquiring patient data, and may change as the patient data changes (as
Petitioner contends)? We conclude Petitioner has the better position.
Claim 1, from which claim 7 depends, recites a first alarm threshold applied
during a first period of time and a second alarm threshold applied during a
second period of time, wherein the latter “replace[s]” the former. See
Ex. 1001, 14:6–9 (first alarm threshold), 14:13–16 (second alarm threshold).
It is undisputed that both of these alarm thresholds correspond to an adaptive
threshold AT applied at different times, as illustrated in Figure 6 of the
’218 patent. See id. at Fig. 6, 6:35–38, 7:40–8:6. Therefore, Patent Owner’s
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position is inconsistent with the ’218 patent specification, and Petitioner’s
position is consistent with the ’218 patent specification.
Applying Petitioner’s claim construction, we find Bock’s tracking
threshold 314 is a predetermined alarm threshold, because its calculation is
determined prior to acquiring patient data. Specifically, Bock predetermines
that tracking threshold 314 is “a preset amount different than the calculated
representative value [310],” such as a constant percentage lower than
calculated representative value 310. Ex. 1005, Fig. 2, 4:4–14, 6:23–25.
We conclude Petitioner has demonstrated by a preponderance of the
evidence that claim 7 is unpatentable as having been obvious over Bock and
Kiani.
5. Claims 2–4 and 12–15
Petitioner provides arguments and evidence, including testimony from
Dr. Yanulis, in support of contending claims 2–4 and 12–15 are unpatentable
as having been obvious over Bock and Kiani. Pet. 38–43; Ex. 1003 ¶¶ 116–
121, 123–133. In defense of these claims, Patent Owner relies solely on
arguments relating to claim 1. See, e.g., PO Resp. 34, 39–40, 41. For the
reasons provided in Section III.D.3 above in the context of claim 1, we
conclude Patent Owner’s defense is not persuasive. Our analysis of claim 1
applies equally well to independent claim 12.
We further find a preponderance of the evidence supports Petitioner’s
contention that Bock discloses the limitations recited in dependent claims
2–4 and 13–15, for the following reasons.
Concerning claims 2 and 13, Bock’s representative value 310 is a
“baseline measurement” calculated from acquired data stream 312 over the
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first period of time, which Petitioner equates to minutes 0–21 in Bock’s
Figure 2. See Ex. 1001, 14:41–47 (claim 2), 16:33–40 (claim 13); supra
Section III.D.3(c). Concerning claims 3 and 14, Bock’s representative
value 310 is also a “baseline measurement” calculated from acquired data
stream 312 over the second period of time, which Petitioner equates to after
minute 21 in Bock’s Figure 2. See Ex. 1001, 14:48–54 (claim 3), 16:41–48
(claim 14); Pet. 39 (stating “the second period of time” in Bock is “after
minute 21”). Specifically, Bock’s representative value 310 is adjusted to
represent acquired data stream 312 over time. Ex. 1005, Fig. 2, 3:44–4:3,
5:52–6:6; see Pet. 38–39, 43; Ex. 1003 ¶¶ 116, 118, 131–132.
Concerning claims 4 and 15, Bock’s “lower limit” (i.e., lower
extremity limit 308 in Figure 2) “is predetermined and corresponds to a
minimum parameter value for oxygen saturation.” See Ex. 1001, 14:55–57
(claim 4), 16:49–51 (claim 15). Specifically, Bock’s lower extremity
limit 308 represents a value that is “extreme for the characteristic being
monitored,” and “may represent a value for the characteristic that is unlikely
to be acquired from a patient who does not require immediate attention.”
Ex. 1005, 3:50–58, 6:7–15; see Pet. 40, 43; Ex. 1003 ¶¶ 120, 133.
Thus, we conclude Petitioner has demonstrated by a preponderance of
the evidence that claims 2–4 and 12–15 are unpatentable as having been
obvious over Bock and Kiani.
E. Obviousness over Bock, Woehrle, and Kiani
Petitioner asserts claims 5, 6, 8–10, and 16–18 of the ’218 patent are
unpatentable as having been obvious over Bock, Woehrle, and Kiani.
Pet. 44–50. Patent Owner opposes. PO Resp. 42–52. We have reviewed
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Petitioner’s and Patent Owner’s arguments, and the evidence of record. We
conclude a preponderance of the evidence supports Petitioner’s assertions as
to all challenged claims 5, 6, 8–10, and 16–18. We first briefly summarize
Woehrle, then we address the parties’ contentions as to obviousness.
1. Woehrle Disclosure
Woehrle discloses “a method for controlling an alarm in a medical
instrument or system . . . detecting at least one physiological parameter of
the patient,” such as oxygen saturation. Ex. 1007, code (57), 2:11–14.7
Woehrle indicates “in order to avoid nuisance alarms it is known to use an
alarm delay between the event of exceeding or under-running a preset limit
and the actual generation of the alarm,” and Woehrle’s method seeks to
“avoid generating nuisance alarms to a high degree.” Id. at 2:15–20, 3:6–9
(emphasis added).
Figure 1 of Woehrle is reproduced here.

7 Our citations to Woehrle (Exhibit 1007) refer to the page numbers added
by Petitioner to the bottom of each page, as is done in the Petition.
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Figure 1 illustrates how, in Woehrle, an alarm delay (the vertical axis) is
determined as a function of the degree by which a measured oxygen
saturation value exceeds an alarm limit (the horizontal axis) which triggers
the alarm. Id. at 3:15–21, 3:27–31, 4:12–19, 7:15–27. As shown, “the
function yields a longer alarm delay for a lesser degree of exceeding or
under-running the predefined threshold, respectively, and vice versa,” so
“the more the present value exceeds or under-runs the predefined threshold
the earlier an alarm is generated.” Id. at 4:12–19. A look-up table may be
used instead of the continuous function shown in Figure 1. Id. at 8:31–9:1.
2. Claim 5
Claim 5 recites: “The system of claim 1, wherein the one or more
hardware processors are further configured to wait for a time delay prior to
the triggering of the second alarm, and wherein the time delay is a function
of the second alarm threshold.” Ex. 1001, 14:58–62 (emphasis added).
Petitioner provides arguments and evidence, including testimony from
Dr. Yanulis and Dr. Bergeron, in support of contending claim 5 is
unpatentable as having been obvious over Bock, Woehrle, and Kiani.
Pet. 44–47; Pet. Reply 15–20; Ex. 1003 ¶¶ 134–142; Ex. 1040 ¶¶ 79–92.
Patent Owner provides arguments and evidence in opposition, including
testimony from Mr. Goldberg. PO Resp. 42–51; Ex. 2011 ¶¶ 85–98.
a) Petitioner’s Case
Petitioner relies on Bock and Kiani for the obviousness of parent
claim 1. See supra Section III.D.3; Pet. 44–45; Ex. 1003 ¶ 137. As already
discussed, we agree with Petitioner here over Patent Owner’s objections.
See supra Section III.D.3; PO Resp. 42–43; Ex. 2011 ¶¶ 86–88.
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Petitioner then relies on Woehrle as disclosing the time delay
limitation of claim 5. Pet. 44, 45–46; Ex. 1003 ¶¶ 134–140; Ex. 1040 ¶ 80.
Petitioner cites the time delay schemes shown in Woehrle’s Figure 1, and in
Woehrle’s similar look-up table, as “setting a time delay for the alarm based
on the deviation between the measured values of the patient and the normal
value (or second threshold).” Pet. 45–46 (citing Ex. 1007, 3:10–4:3,
7:15–9:14); Pet. Reply 15–16 (same); Ex. 1003 ¶¶ 138–140. Patent Owner
does not challenge these contentions, and we determine they are supported
by a preponderance of the evidence cited by Petitioner. See Ex. 1007,
3:27–31 (“[I]t is an important idea of the invention to consider the present
situation of the physiological parameter in order to determine the alarm
delay in such a way that in case of decreasing abnormalities of the detected
values a longer alarm delay is determined and vice versa” so “a present
alarm delay is extended if the patient’s condition starts to improve again.”),
7:15–8:1 (Fig. 1), 8:31–9:1 (look-up table).
For obviousness, Petitioner contends both Bock and Woehrle are
directed to avoiding nuisance alarms in patient oxygen saturation monitoring
devices. Pet. 44, 46–47; Ex. 1003 ¶¶ 135–136, 140. Petitioner asserts a
POSITA would have been motivated to modify Bock’s system by adding an
alarm time delay, such as disclosed by Woehrle, to provide an “additional”
method of reducing nuisance alarms in Bock. Pet. 44, 46; Ex. 1003 ¶¶ 136,
140. Petitioner argues this would have used a known technique to improve a
similar device in a similar way, by reducing nuisance alarms and providing
delays in the alarm when an oxygen saturation alarm limit has been
exceeded for some set period of time. Pet. 46–47; Ex. 1003 ¶¶ 140–141.
This would have improved Bock’s alarm by “predictably reduc[ing]
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nuisance alarms in two ways,” according to Petitioner. Pet. 47 (emphasis
added) (citing Ex. 1003 ¶ 142). Dr. Yanulis identifies these as: (1) from
Bock, customizing alarm thresholds based on the patient’s measured oxygen
saturation levels, rather than a default or standard threshold; and (2) from
Woehrle, “utilizing pre-alarm delays to prevent activation of alarms until
and unless the physiological parameter measurement exceeds a threshold for
a period of time to ensure it is not transient and requires medical
intervention.” Ex. 1003 ¶ 142.
Petitioner’s Reply expounds on Dr. Yanulis’s second way that
combining Bock and Woehrle would predictably reduce nuisance alarms.
See Pet. Reply 18–20. Petitioner and Dr. Bergeron here describe Bock’s use
of tracking threshold 314 and alarm limit 316 as “an effective delay” in
triggering an alarm, due in part to the decaying nature of alarm limit 316.
Id. at 18–19 (emphasis added); Ex. 1040 ¶¶ 74, 87–88; see also Ex. 1005,
Figs. 2–3, 4:41–5:2 (illustrating and describing the decay of alarm
limit 316). According to Dr. Bergeron: “In critical conditions, a caregiver
wants more certainty [than Bock’s alarm limit 316 provides] in how long the
effective delay would be,” and this desire would motivate a POSITA “to
replace the effective delay [of Bock’s alarm limit 316] with a preset delay”
as disclosed by Woehrle. Ex. 1040 ¶¶ 88–89 (emphasis added); Pet.
Reply 19 (also citing Ex. 1003 ¶¶ 138, 142, 146). Dr. Bergeron concludes
this is “merely . . . substituting one known option for another to predictably
yield a system with time delays that are not dependent on a patient’s
measured parameter after starting the delay period.” Ex. 1040 ¶ 90
(emphasis added); Pet. Reply 19–20 (citing KSR, 550 U.S. at 418).
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b) Whether the Reply Improperly Presents New Argument
Patent Owner argues Petitioner’s Reply provides a “belated
explanation” of obviousness in a “new argument[] . . . exceeding the proper
scope of a reply.” Sur-reply 9–10, 21–22 (citing Inst. Dec. 48; PTAB
Consolidated Trial Practice Guide (Nov. 2019) (CTPG)8, 73–74; 37 C.F.R.
§ 42.23). Patent Owner particularly asserts the Reply’s description of
Bock’s alarm limit 316 as “effectively an alarm delay” (Pet. Reply 18–19) is
“absent from the Petition,” which in fact “argued the opposite” because the
Petition relied on Woehrle and not Bock as disclosing the time delay of
claim 5. Id. (citing Pet. 13, 44–50; Ex. 1003 ¶ 52; Inst. Dec. 41 n.9).
Our rules require that the Petition must provide “[a]ll arguments for
the relief requested,” and that the Reply “may only respond to arguments
raised in the . . . patent owner response.” 37 C.F.R. § 42.23(b); CTPG
73–74. Thus, “Petitioner may not submit new evidence or argument in reply
that it could have presented earlier, e.g. to make out a prima facie case of
unpatentability,” but Petitioner “may submit rebuttal evidence in support of
its reply.” CTPG 73–75 (citations omitted).
We conclude the Reply does not improperly present new argument or
evidence. The Petition states: “The combination of Bock . . . and Woehrle
would have predictably reduced nuisance alarms in two ways.” Pet. 47
(citing Ex. 1003 ¶ 142). While the Petition does not spell out the “two
ways” (id.), the cited testimony from Dr. Yanulis does (Ex. 1003 ¶ 142).
Dr. Yanulis here cites Woehrle as evidencing the benefits provided by
“utilizing pre-alarm delays to prevent activation of alarms until and unless

8 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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the physiological parameter measurement exceeds a threshold for a period of
time to ensure it is not transient and requires medical intervention.”
Ex. 1003 ¶ 142 (emphasis added); id. ¶¶ 138–142 (discussed at Pet. 45–47).
This argument and evidence sufficiently support the positions taken in the
Reply as to the obviousness of replacing Bock’s alarm limit 316 with
Woehrle’s preset time delay, to avoid the Board’s proscription against
raising new arguments in the Reply.
No doubt, the Reply’s specific discussion of Bock’s alarm limit 316
being “effectively an alarm delay” (Pet. Reply 18–19) and portions of
Dr. Bergeron’s corresponding testimony (Ex. 1040 ¶¶ 81, 87–91) are not
reflected in the Petition. Nonetheless, Petitioner’s obviousness theory
remains the same—it would have been obvious to replace Bock’s alarm
limit 316 with Woehrle’s preset time delay. Compare Pet. 44–48 and
Ex. 1003 ¶¶ 134–146, with Pet. Reply 18–20 and Ex. 1040 ¶¶ 79–81, 85,
87–90. The Reply’s additional focus on Bock’s pertinent disclosures, and
relating them to Woehrle’s pertinent disclosures, is a permissible reply to the
Patent Owner Response’s opposition to Petitioner’s contentions of
obviousness. Thus, we have considered Petitioner’s Reply as part of
reaching our present Decision.
c) Patent Owner’s Opposition on the Merits
On the merits, Patent Owner attacks Petitioner’s case for a motivation
to combine Bock and Woehrle, and for a reasonable expectation of success,
leading to the invention of claim 5. See PO Resp. 42–51; Ex. 2011 ¶¶ 85–
98. We consider each issue in turn.
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d) Motivation to Combine
Patent Owner argues the Petition fails to establish a motivation for
combining the alarm method of Bock with the time delay of Woehrle. PO
Resp. 43–48; Ex. 2011 ¶¶ 89–94. Patent Owner asserts: “[B]y arguing that
both Bock and Woehrle describe ways to reduce nuisance alarms, Petitioner
is merely contending that the references are directed to the same field of
endeavor,” which “is not sufficient to establish a motivation to combine.”
PO Resp. 44 (citations omitted). Also: “Petitioner fails to identify why one
of ordinary skill would have been motivated to combine the respective
approaches to reducing alarms taken by Bock and Woehrle.” Id. at 45;
Ex. 2011 ¶ 90. Indeed, according to Patent Owner and Mr. Goldberg, a
POSITA “would have expected that layering multiple approaches to
reducing alarms would materially increase the risk of missing a patient’s life
threatening emergency because multiple layers of alarm reduction could
suppress actionable alarms,” so a POSITA would have been dissuaded “from
layering Woehrle’s time delay approach on top of Bock’s alarm system.”
PO Resp. 45–46; Ex. 2011 ¶ 90 (citing Ex. 1005, 1:18–20; Ex. 1007,
2:15–20).
Patent Owner further points out that claim 5 recites the time delay “is
a function of the second alarm threshold”—which, in Bock, is tracking
threshold 314. PO Resp. 46–47; Ex. 2011 ¶ 91. Patent Owner asserts
Petitioner fails to explain why a POSITA would have applied a time delay to
Bock’s use of tracking threshold 314, given that “exceeding tracking
threshold 314 sets the alarm limit 316, it does not trigger an alarm.” PO
Resp. 46–47; Ex. 2011 ¶ 91. Mr. Goldberg testifies: “Adding a time delay to
Bock’s tracking threshold 314 would thus mean that the acquired data 312
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would have to exceed the tracking threshold 314 for some amount of time
before the alarm limit 316 would be created,” which “would not . . . delay an
alarm ‘based on the degree of deviation from the normal value’ of a
parameter, as Dr. Yanulis characterizes the teachings of Woehrle.” Ex. 2011
¶ 91 (citing Ex. 1003 ¶ 140). Mr. Goldberg further opines a POSITA
“would not have expected a potential benefit from adding a time delay after
the measured data [312] crosses Bock’s tracking threshold [314],” because
“Woehrle’s time delay is applied after an alarm otherwise would have been
triggered,” whereas crossing Bock’s tracking threshold 314 merely
“establishes the alarm limit 316.” Id. ¶ 92.
Petitioner replies that “[t]he Petition adequately set out the motivation
to combine” by describing “how the Woehrle system reduces alarms using
time delays based on the deviation between the measured values of the
patient and the normal (or second threshold) value.” Pet. Reply 15–16
(citing Pet. 45–46). Petitioner insists: “Using these time delays in [Bock]
provides another way for the tightening thresholds to be implemented.” Id.
(citing Ex. 1003 ¶ 146; Ex. 1040 ¶ 80). In particular, according to
Petitioner, a POSITA “would have known various ways to delay alarms
including delaying them based on the dynamic thresholds of Bock or the
predetermined alarm delays of Woehrle that decrease in duration as a
parameter measurement gets further out-of-limits.” Id. at 16; Ex. 1040 ¶ 81.
Thus, Petitioner argues Dr. Yanulis’s reasoning for motivation to combine
“goes far beyond simply stating the prior art is direct[ed] to the same field of
endeavor,” thereby distinguishing case law cited by Patent Owner. Pet.
Reply 16–17 (citing Ex. 1003 ¶¶ 137–142). Petitioner finally asserts:
“Nothing about the combination causes a risk of missing a true alarm,”
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because this “is a risk in any system designed to minimize nuisance alarms,
and is one that a [POSITA] would anticipate and avoid,” such as “by simply
adjusting parameters, e.g. shortening alarm delay periods” or relying on
Bock’s extremity limit 308. Id. at 17–18 (citing Ex. 1003 ¶¶ 39, 141–142,
146; Ex. 1040 ¶¶ 81–86; Ex. 1042, 16:8–19).
We conclude Petitioner has established, by a preponderance of the
evidence, a sufficient motivation for the proposed obviousness of replacing
Bock’s alarm limit 316 with Woehrle’s preset time delay. Dr. Yanulis
testifies, and Patent Owner does not dispute, that Bock and Woehrle both
disclose oxygen saturation monitoring systems that seek to avoid nuisance
alarms. See Ex. 1003 ¶ 60 (citing Ex. 1007, 3:7–31, 8:31–9:1); id. ¶ 74
(citing Ex. 1005, 1:8–20); id. ¶¶ 135–136, 140. Dr. Yanulis describes how
Bock and Woehrle seek to achieve this goal in different ways, with Bock
“basing alarm thresholds on a patient’s actual physiological parameter
measurements” (id. ¶ 140), and Woehrle “configuring a processor to wait for
a time delay . . . prior to triggering a second alarm” with the delay being “a
function of the second alarm threshold” (id. ¶ 138). Further according to
Dr. Yanulis, Woehrle “explains the need for alarm delays based on the
degree of deviation from the normal value for that parameter to reduce false
alarms while also generating alarms more quickly for more severe parameter
measurements requiring quicker medical intervention.” Id. ¶ 140. Thus,
Dr. Yanulis’s view is that adding Woehrle’s preset time delay to Bock’s
system would advantageously provide an additional means of reducing
nuisance alarms in Bock. Id. ¶¶ 140–142.
Dr. Bergeron’s testimony is to the same effect, and is persuasive.
Dr. Bergeron concludes that replacing Bock’s alarm limit 316, which is an
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effective delay in triggering an alarm, with Woehrle’s preset time delay is
the simple substitution of one delay for another delay, and would have been
advantageous. Ex. 1040 ¶¶ 87–90. The advantage is that, “[i]n critical
conditions,” Woehrle’s preset time delay provides “more certainty” because
it is independent of “the patient’s measured” oxygen saturation, whereas in
Bock the effective delay requires acquired data stream 312 to drop below
alarm limit 316. Id.
Dr. Bergeron also persuasively explains how replacing Bock’s alarm
limit 316 with Woehrle’s preset time delay would not materially increase the
risk of the alarm system missing true alarm, or life threatening, situations.
Dr. Bergeron acknowledges that “[m]issing a true alarm is a risk in any
system designed to minimize nuisance alarms,” which both Bock and
Woehrle attempt to do. Ex. 1040 ¶ 82. Nonetheless, Dr. Bergeron testifies a
POSITA would have known that “[t]hese risks can be greatly offset by
simply adjusting parameters, such as shortening alarm delay periods.” Id.
¶¶ 83–84. Dr. Bergeron explains that Bock’s extremity limit 308 provides
further insurance against the alarm system missing life threatening
situations. See id. ¶ 86; Ex. 1005, Fig. 2, 3:50–58, 6:7–15 (discussing how
extremity limit 308 represents an extreme lower value for the monitored
characteristic, requiring immediate attention if it is exceeded by acquired
data stream 312, so Bock’s processor 27 generates an immediate alarm when
this occurs).
Patent Owner’s opposition is premised largely on there being no
reason to implement a time delay along with Bock’s alarm limit 316.
However, as discussed above, Petitioner proposes replacing Bock’s alarm
limit 316 with Woehrle’s preset time delay.
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Mr. Goldberg’s contrary testimony also is not persuasive. He does
not explain the reasons behind his conclusion that the risk of missing true
alarm situations would have led a POSITA away from using Woehrle’s
preset time delay in Bock’s alarm system. Ex. 2011 ¶ 90. The disclosures
of Bock and of Woehrle cited by Mr. Goldberg establish that designing an
oxygen saturation monitoring system presents a Goldilocks design
challenge: the system needs to trigger alarms for significant patient events,
but not trigger alarms for non-significant patient events. See Ex. 1005,
1:18–20; Ex. 1007, 2:15–20 (implementing alarm delays “is often a
compromise between warning the clinical staff fast enough about a change
in the patient’s condition on the one hand and generation of too many
unjustified and, thus, nuisance alarms which detract the clinical staff from
other work, especially more important alarms, on the other hand”).
Nonetheless, the prior art establishes that using a preset time delay was one
tool that could be used to avoid nuisance alarms, if managed appropriately as
a POSITA would have known how to do. See Ex. 1007, 2:15–20 (“[I]n
order to avoid nuisance alarms it is known to use an alarm delay between the
event of exceeding or under-running a preset limit and the actual generation
of the alarm.”). Mr. Goldberg does not persuasively explain why this
routine design challenge would have dissuaded a POSITA from
implementing Woehrle’s preset time delay in Bock’s alarm system.
Patent Owner’s argument that Petitioner fails to address claim 5’s
requirement that “the time delay is a function of the second alarm threshold”
(Ex. 1001, 14:61–62) also is not persuasive. Woehrle’s preset time delay
satisfies this claim requirement. See, e.g., Pet. 45–46; Pet. Reply 15–16;
Ex. 1003 ¶¶ 138–139; Ex. 1040 ¶¶ 80–81, 88. In particular, Woehrle states
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it is “important . . . to consider the present situation of the physiological
parameter in order to determine the alarm delay in such a way that in case of
decreasing abnormalities of the detected values a longer alarm delay is
determined and vice versa.” Ex. 1007, 3:27–31 (emphases added). Thus,
according to Woehrle’s time delay method, the time delay period is preset to
be “longer . . . for a lesser degree of exceeding” an alarm threshold, and
shorter for a greater degree of exceeding an alarm threshold. Id. at 4:12–19
(emphasis added), 7:15–8:1 (Fig. 1), 8:31–9:1 (look-up table). Thus,
Petitioner’s proposal to replace Bock’s alarm limit 316 with Woehrle’s
present time delay leads to the invention of claim 5, based on Woehrle’s
disclosure that the time delay should be preset as a function of the degree to
which acquired data stream 312 exceeds tracking threshold 314.
Thus, we conclude Petitioner has established, by a preponderance of
the evidence, a sufficient motivation for the proposed obviousness of
replacing Bock’s alarm limit 316 with Woehrle’s preset time delay.
e) Reasonable Expectation of Success
Patent Owner argues the Petition fails to establish a reasonable
expectation of success in combining the alarm method of Bock with the
preset time delay of Woehrle, to reach the invention of claim 5. PO
Resp. 48–51; Ex. 2011 ¶¶ 95–98. Patent Owner first relies on the reasoning
we provided in the Institution Decision, where we concluded “Patent Owner
may have a valid point” in attacking reasonable expectation of success. See
PO Resp. 48–49; Inst. Dec. 47–48. Patent Owner particularly asserts a
POSITA “would not have reasonably understood how to successfully
incorporate Woehrle’s time delay into Bock’s alarm scheme as a function of,
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or based on, tracking threshold 314,” which Petitioner equates to the “second
alarm threshold” of claims 1 and 5. PO Resp. 49–50; Ex. 2011 ¶¶ 95–97.
According to Mr. Goldberg: “Because exceeding tracking
threshold 314 does not trigger alarm 318, it would be unclear to a [POSITA]
how a time delay would even relate to tracking threshold 314” or “when
such a time delay would even start in Bock’s systems.” Ex. 2011 ¶ 96.
Patent Owner adds that Petitioner fails to explain how adding a time delay to
Bock’s setting of alarm limit 316 after acquired data stream 312 crosses
alarm threshold 314 corresponds to claim 5’s requirements of “wait[ing] for
a time delay prior to the triggering of the second alarm,” and “the time delay
is a function of” threshold 314. PO Resp. 50 (emphasis added to claim
language); Ex. 2011 ¶ 97.
Petitioner replies that replacing Bock’s alarm limit 316 with
Woehrle’s preset time delay would have been within the capabilities of a
POSITA. Pet. Reply 20; Ex. 1040 ¶¶ 91–92 (“[I]mplementing a time delay
would be known to a [POSITA].”). In support, Petitioner asserts the
’218 patent “does not describe how claim 5 is implemented because it would
have been known to a [POSITA], and therefore is unnecessary to describe in
detail.” Pet. Reply 20; Ex. 1040 ¶ 91.
Patent Owner responds that Petitioner has failed to establish a
reasonable expectation of success in replacing Bock’s alarm limit 316 with
Woehrle’s preset time delay. Sur-reply 22–23. Patent Owner argues
“Bock’s alarm limit [316] is a parameter value at which an alarm will
trigger—not a time delay,” so Petitioner’s proposal to replace alarm
limit 316 with Woehrle’s preset time delay is not the substitution of a known
equivalent as Petitioner would have it. Id. at 9, 23 (citing Ex. 1005, Fig. 2,
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4:26–28); Ex. 2011 ¶¶ 32, 37–38, 93–94. Patent Owner further asserts
replacing Bock’s alarm limit 316 with Woehrle’s preset time delay “would
leave nothing to trigger an alarm.” Sur-reply 23 (citing Ex. 1005, 4:26–28).
Petitioner’s theory for obviousness would also improperly “fundamentally
change Bock’s principle of operation,” according to Patent Owner, which is
“the interaction . . . between the tracking threshold 314 and the alarm
limit 316.” Id.; Tr. 31:1–7 (citing Ex. 1005, 1:16–20).
We conclude Petitioner has established, by a preponderance of the
evidence, that a POSITA would have had a reasonable expectation of
success in replacing Bock’s alarm limit 316 with Woehrle’s preset time
delay. The evidence shows that preset time delays were a well developed
tool in the context of oxygen saturation monitoring systems at the time of the
’218 patent’s invention. For example, the ’218 patent describes time delays
as being known in the art prior to the ’218 patent’s invention. See Ex. 1001,
Fig. 1, 2:54–3:2 (illustrating and describing a prior art oxygen saturation
measurement system incorporating delay alarm threshold DL with time
delay TD); id. at 3:24–59 (disclosing that the ’218 patent’s adaptive alarm
system overcomes a baseline drift problem that occurs in the system of
Figure 1), 6:20–23 (referring to the “conventional fixed alarm thresholds
with and without an alarm time delay” shown in Figure 1 (emphasis added)).
Woehrle similarly describes time delays as being previously known, and
discusses one previously known alarm scheme employing a time delay. See
Ex. 1007, 2:15–30. Thus, implementing time delays was a known
technology to a POSITA prior to the ’218 patent.
Patent Owner’s opposition is unpersuasive, largely because it
misconstrues the nature of Petitioner’s proposed obviousness. Petitioner
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proposes to replace Bock’s alarm limit 316 with Woehrle’s preset time
delay. See, e.g., Pet. 44–48; Pet. Reply 18–20; Ex. 1003 ¶¶ 134–146;
Ex. 1040 ¶¶ 79–81, 85, 87–90. Thus, Patent Owner’s and Mr. Goldberg’s
various discussions of the difficulty of implementing a preset time delay
with Bock’s alarm limit 316 are not pertinent to Petitioner’s theory of
obviousness. See PO Resp. 48–50; Ex. 2011 ¶¶ 95–98. Applying
Petitioner’s theory, it would have been well within the capabilities of
POSITA to incorporate a preset time delay in Bock’s alarm scheme, wherein
the delay period begins at the time acquired data stream 312 crosses tracking
threshold 314, based on Woehrle’s discussion of implementing time delays
based on a “predefined threshold defining an upper or lower limit for a
normal range of the physiological parameter.” Ex. 1007, 4:12–19, 7:15–8:1
(Fig. 1), 8:31–9:1 (look-up table).
When instituting the present review, we stated “we do not ascertain
any discussion in the Petition explaining how [claim 5] would be satisfied by
incorporating a time delay into Bock’s alarm scheme.” Inst. Dec. 48 (citing
Pet. 44–47). Now, based on the record as fully developed during trial, we
understand Petitioner proposes to replace Bock’s alarm limit 316 with
Woehrle’s preset time delay, as set forth above.
Finally, we disagree with Patent Owner’s position that replacing
Bock’s alarm limit 316 with Woehrle’s preset time delay would
fundamentally change Bock’s principle of operation. Bock’s principle of
operation is to reduce nuisance alarms in an oxygen saturation monitoring
system, specifically “to avoid registering false positives, while avoiding
false negatives (not registering the occurrence of a significant event).”
Ex. 1005, 1:16–20. As discussed in detail above, the principle remains the
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same even after Bock is modified to include Woehrle’s preset time delay,
which is another tool to employ when addressing this Goldilocks design
objective.
Thus, we conclude Petitioner has established, by a preponderance of
the evidence, that a POSITA would have had a reasonable expectation of
success in replacing Bock’s alarm limit 316 with Woehrle’s preset time
delay.
f) Conclusion as to Claim 5
Based on the foregoing arguments and evidence, we conclude
Petitioner has demonstrated by a preponderance of the evidence that claim 5
is unpatentable as having been obvious over Bock, Woehrle, and Kiani.
3. Claims 6 and 8
Claim 6 recites: “The system of claim 5, wherein the time delay
decreases as the difference between the at least one value and the lower limit
diminishes.” Ex. 1001, 14:63–65. Claim 8 is an independent claim that is
similar to claim 1, except that claim 8 recites that the processor is
“configured to . . . apply a time delay based on the second alarm threshold,
wherein the time delay approaches zero as the at least one oxygen saturation
value obtained over the first period of time approaches the lower limit.” Id.
at 15:1–39.
Petitioner provides arguments and evidence, including testimony from
Dr. Yanulis, in support of contending claims 6 and 8 are unpatentable as
having been obvious over Bock, Woehrle, and Kiani. Pet. 47–48 (claim 6),
48–50 (claim 8); Ex. 1003 ¶¶ 143–154. In defense of these claims, Patent
Owner relies solely on arguments relating to claim 5. See, e.g., PO Resp. 48.
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For the reasons provided in Section III.E.2 above in the context of claim 5,
we conclude Patent Owner’s defense is not persuasive.
We further find a preponderance of the evidence supports Petitioner’s
contention that Woehrle discloses the time delay limitations recited in
claims 6 and 8. See Pet. 47–48 (claim 6), 49 (claim 8). In particular,
Woehrle states that “the function for determining the alarm delay considers
the degree by which the present value exceeds or under-runs at least one
predefined threshold” so that “the function yields a longer alarm delay for a
lesser degree of exceeding or under-running the predefined threshold,
respectively, and vice versa.” Ex. 1007, 4:12–17 (emphasis added);
Ex. 1003 ¶ 143. This is shown, for example, in Figure 1 of Woehrle, which
shows an inverse relationship between the degree by which the measured
values exceed a predefined alarm threshold (horizontal axis) and the alarm
delay (vertical axis). See Ex. 1007, Fig. 1, 7:15–27. This is also shown in
the look-up table cited by Petitioner and Dr. Yanulis. See id. at 8:31–9:1;
Pet. 47–48; Ex. 1003 ¶¶ 144–145.
Dr. Yanulis testifies, and we agree, that these disclosures “teach[] the
pre-alarm time delay gets shorter as the difference between the measured
SpO2 measurement gets more severe and gets closer to a lower limit.”
Ex. 1003 ¶ 143; Pet. 47. In particular, in relation to claim 6, Woehrle’s
Figure 1 shows that the time delay decreases (lower on the vertical axis) as
the difference between the measured oxygen saturation values and a lower
limit diminishes (to the right on the horizontal axis). We acknowledge that
Woehrle’s horizontal axis does not reflect, directly, the difference between
measured oxygen saturation values and a lower limit, which is the
characteristic recited in claim 6.
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Nonetheless, when the teachings of Woehrle’s Figure 1 are applied
within the context of Bock’s Figure 2, it is apparent that the combination
leads to the subject matter recited in claim 6. This is illustrated by our
annotations here to Bock’s Figure 2:
Figure 2 illustrates Bock’s alarm scheme, and our annotations reflect how,
within the region between tracking threshold 314 (green) and lower
limit 308 (blue), a diminishing difference between measured data 312 and
lower limit 308 per claim 6 corresponds to an increasing amount by which
measured data 312 exceeds or drops below tracking threshold 314 per
Woehrle’s horizontal axis. See, e.g., Ex. 1003 ¶¶ 145–146. Thus, Woehrle
teaches that, when a preset time delay is applied to Bock’s system, it would
be beneficial to shorten the delay time when acquired data stream 312 gets
more critical by exceeding (dropping below) tracking threshold 314 by a
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greater amount. See id. Stated another way, Woehrle teaches that it would
be beneficial to lengthen the delay time when acquired data stream 312 gets
less critical by exceeding (dropping below) tracking threshold 314 by a
lesser amount, to reduce nuisance alarms. See id.
In relation to claim 8, Woehrle’s Figure 1 shows that the time delay
approaches zero (lower on the vertical axis) as the measured oxygen
saturation values approach the lower limit (to the right on the horizontal
axis). As with claim 6 discussed above, it is apparent from Bock’s Figure 2
that data 312 approaching lower limit 308, per claim 8, corresponds to an
increase in the amount by which data 312 exceeds (drops below) tracking
threshold 312, and hence leads to the time delay approaching zero as
required by claim 8 by applying Woehrle’s teachings. See, e.g., Ex. 1003
¶ 151.
We conclude Petitioner has demonstrated by a preponderance of the
evidence that claims 6 and 8 are unpatentable as having been obvious over
Bock, Woehrle, and Kiani.
4. Claims 9 and 18
Claim 9 recites: “The system of claim 8, wherein the first alarm
threshold is predetermined.” Ex. 1001, 15:40–41 (emphasis added).
Claim 18 depends from claim 12 to add the same limitation as claim 9. Id.
at 16:61–62.
Petitioner contends “Bock teaches that the alarm threshold may be
predetermined,” as discussed above in relation to claim 7 and Petitioner’s
first ground. Pet. 40, 50. Patent Owner argues Bock’s tracking
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threshold 314 is not predetermined, as discussed above in relation to claim 7
and Petitioner’s first ground. See PO Resp. 41–42, 51–52.
As discussed above in relation to claim 7 and Petitioner’s first ground,
resolution of this dispute turns principally on claim construction of the term
“predetermined,” and Petitioner has the better position. See supra
Section III.D.4. Therefore, we conclude Petitioner has demonstrated by a
preponderance of the evidence that claims 9 and 18 are unpatentable as
having been obvious over Bock, Woehrle, and Kiani.
5. Claims 10, 16, and 17
Petitioner provides arguments and evidence, including testimony from
Dr. Yanulis, in support of contending dependent claims 10, 16, and 17 are
unpatentable as having been obvious over Bock, Woehrle, and Kiani.
Pet. 50 (referring back to previous sections of the Petition); Ex. 1003
¶¶ 156–157. Patent Owner does not address these dependent claims
separately from their respective parent independent claims 8 and 12. See,
e.g., PO Resp. 48.
Concerning claim 10, Bock’s “lower limit” (i.e., lower extremity
limit 308 in Figure 2) “is predetermined and corresponds to a minimum
parameter value for oxygen saturation.” See Ex. 1001, 15:42–44 (claim 10);
supra Section III.D.5 (discussing corresponding limitation in claim 4).
Thus, in combination with the established obviousness of the parent claim 8
(see supra Section III.E.3), we conclude Petitioner has demonstrated by a
preponderance of the evidence that claim 10 is unpatentable as having been
obvious over Bock, Woehrle, and Kiani.
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Claim 16 depends from claim 12 to add “waiting for a time delay
prior to the triggering of the second alarm, and wherein the time delay is a
function of the second alarm threshold.” Ex. 1001, 16:52–57. Claim 17
depends from claim 16 and adds “the time delay decreases as the difference
between the at least one oxygen saturation value and the lower limit
diminishes.” Id. at 16:58–60. Thus, our previous discussions as to the
obviousness of claims 5 and 6 apply here too. See supra Sections III.E.2–3.
We conclude Petitioner has demonstrated by a preponderance of the
evidence that claims 16 and 17 are unpatentable as having been obvious over
Bock, Woehrle, and Kiani.
IV. SUMMARY OF CONCLUSIONS
In summary, we determine a preponderance of the evidence
establishes claims 1–10 and 12–18 of the ’218 patent are unpatentable, as
shown in the following table:9
Claims 35 U.S.C. § References
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–4, 7,
12–15 103
Bock,
Kiani
1–4, 7,
12–15

9 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.
16,654 (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
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Claims 35 U.S.C. § References
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
5, 6, 8–10,
16–18 103
Bock,
Woehrle,
Kiani
5, 6, 8–10,
16–18
Overall
Outcome 1–10, 12–18
V. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–10 and 12–18 of the ’218 patent have been
proven by a preponderance of the evidence to be unpatentable; and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
We are already aware of Application Nos. 16/184,908 and 16/800,971.
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PETITIONER:

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

PATENT OWNER:

Benjamin A. Katzenellenbogen
Irfan A. Lateef
Brian C. Claassen
Jared C. Bunker
Daniel C. Kiang (pro hac vice)
KNOBBE, MARTENS, OLSON, & BEAR, LLP
2bak@knobbe.com
2ial@knobbe.com
2bcc@knobbe.com
2jcb@knobbe.com
2dck@knobbe.com