`571-272-7822
`
`Paper 35
`Date: November29, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SOTERA WIRELESS, INC.,
`Petitioner,
`
`Vv.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`IPR2020-01078
`Patent RE47,218 E
`
`Before GEORGE R. HOSKINS, JENNIFER MEYER CHAGNON,and
`AMANDAF. WIEKER,Administrative Patent Judges.
`
`HOSKINS, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`IPR2020-01078
`Patent RE47,218 E
`
`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 ofall
`
`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. Weinstituted the petitioned review (Paper 12, “Institution
`
`Decision”or “Inst. Dec.”).
`
`Patent Ownerfiled 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 Ownerfiled 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.”).
`
`Wehavejurisdiction under 35 U.S.C. § 6(b)(4) and § 318(a). This
`
`Decisionis 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.
`
`Wedetermine Petitioner has shown by a preponderance ofthe evidence that
`
`claims 1-10and 12-18 are unpatentable.
`
`Tl.
`
`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 Corporationis 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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`IPR2020-01078
`Patent RE47,218 E
`
`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 detectlight 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 reproducedhere:
`
`100
`
`SpO2 (%)
`
`t
`
`OFF
`
`tt
`——-——-TD
`
`2
`{
`163
`
`B
`
`ts
`
`time
`
`Figure 1 illustrates a prior art oxygen saturation measurement system having
`
`two “lower-limit, fixed-threshold alarm” schemes,at “delay” alarm
`
`threshold D, and at “no delay” alarm threshold ND,. Jd. at 2:54—59
`
`(emphasis added). If the patient’s measured oxygen saturation 110 falls and
`
`stays below delay threshold D, for a time period greater than time delay TD,
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`
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`IPR2020-01078
`Patent RE47,218 E
`
`as shownin Figure 1 from timet; to time t2, then delayed alarm 140is
`
`triggered. Id. at 2:59-3:2. If the patient’s measured oxygensaturation 110
`
`falls below no delay threshold ND,, as shownin Figure | at time ty, then
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`alarm 150 is triggered immediately, without delay. Jd. at 2:61-62, 3:24.
`
`According to the ’218 patent, the fixed nature of delay alarm
`
`threshold Dy undesirably leads to “a baseline drift problem,” which can
`
`generate a “nuisance”or “false” alarm. Jd. 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 whenan oxygensaturation
`
`baseline is established at lower values. Jd. at 3:59-62. In this way, the
`inventive “alarm threshold .
`.
`. adapts to baseline driftin [oxygensaturation]
`and reduce[s] false alarms without a corresponding increase in missed true
`
`alarms.” Jd. at 4:4-8.
`
`Thisis illustrated in Figure 6 of the ’218 patent, reproducedhere:
`
`Parameter
`
`t 600
`
`610
`
`Max
`
`tL 620
`LL 612
`5 622
`+o en _--
`
`624
`
`4
`
`L
`
`1
`
`630
`626
`614
`t 632
`— AT a LL.— parameter
`636
`628
`634
`range
`ATrange
`AT
`t 640
`po —$ - - ~~~ ~~ AT Be
`648
`i)
`646
`
`r650
`
`638
`
`642
`
`616
`
`Aa=0
`
`
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`IPR2020-01078
`Patent RE47,218 E
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`Figure 6 graphs a measured physiological parameter such as oxygen
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`saturation (the vertical axis) over time (the horizontal axis), as generated by
`
`an alarm system having a lowerlimit adaptive alarm threshold AT. Jd.
`
`at 5:34-36, 7:40-47. An adaptive alarm threshold AT is applied whenever
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`the measured oxygensaturation falls within range 650, extending from lower
`
`limit L2 up to maximum value Max,suchasillustrated at segments 620, 630,
`
`and 640. /d. 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 lowerlimit L2 up to limit L;. /d. at 6:15—30,
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`7:9-67, Fig. 5A (adaptive threshold AT line 442 is constrained between
`
`limits Lz and L, along vertical axis).
`
`In a preferred embodiment, lower limit Lz correspondsto the value of
`
`the no delay alarm threshold ND, ofthe prior art system shownin Figure1,
`
`and limit L; correspondsto the value of the delay alarm threshold Dy, of the
`
`prior art system. Id. at 5:66-6:4, 6:20-34. Thefixed alarm threshold that
`
`the prior art implements at limit L; is replaced by adaptive alarm
`
`thresholds AT. /d. at 6:22—34. Each threshold AT, during a given time
`
`period suchasty, tz, or t3, may advantageously be implemented as a time
`
`delay alarm,as the prior art system does withits fixed delay alarm
`
`threshold Dy. Jd. at 6:38—43.
`
`The system determines a baseline B of the patient’s oxygen saturation
`
`during different time periodst), 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. Jd. at 6:15-19. Specifically, the system calculates delta A as
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`a function of: the varying baseline B; pre-set limits L; and L2; and maximum
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`
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`IPR2020-01078
`Patent RE47,218 E
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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— A. Id. at 7:27-39 (Fig. 5A), 7:53-8:6 (Fig. 6).
`
`C.
`
`The Claims ofthe ’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, andusesitalics to identify verbiage added during the reissue
`
`process. Id. Dueto 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. Jd. at 13:62—16:62.
`
`Accordingly, we reproduce claim 1 here, removing the bracketed
`
`verbiage andnotitalicizing 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 configuredto:
`[1(d)] determine oxygensaturation values of the
`patient overa first period of time;
`[1(e)}] when at least one oxygensaturation value
`obtained overthe first period of time exceedsafirst
`alarm threshold, determine whethera first alarm should
`be triggered;
`
`
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`IPR2020-01078
`Patent RE47,218 E
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`[1(f)] access a second alarm threshold to be
`applied during a second period of time subsequentto 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 lowerlimit and at an offset from theat
`least one oxygen saturation value, wherein the offset is
`diminished as a difference betweentheatleastfirst
`oxygen saturation value and the lowerlimit diminishes;
`[1(h)] determine oxygen saturation values of the
`patient over the second period of time; and
`[1(i)] trigger a second alarm basedonat 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
`
`analogousto limitations 1(d)-1(i). See id. at 15:52—16:32.
`
`Claim 8 is a system claim somewhatakin to claim 1. See id. at
`
`15:1-39. Claim 8 differs from claim 1 most significantly in reciting that the
`
`processoris configured to “apply a time delay based on the second alarm
`
`threshold, wherein the time delay approacheszeroas the at least one oxygen
`
`saturation value obtained overthe first period of time approaches the lower
`
`limit.” Jd. at 15:19-23.
`
`Dz
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`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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`
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`IPR2020-01078
`Patent RE47,218 E
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`
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`Claims Challenged|35 U.S.C.§
`
`
`
`
`
`5, 6, 8-10, 16-18
`
`Bock, Woehrle?, 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).
`
`Ill. ANALYSIS
`
`A.
`
`Statement ofLaw
`
`Petitioner bears the burden of proving unpatentability of the
`
`challenged claims, and the burden of persuasion nevershifts 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 preponderanceofthe 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 obviousat the time the
`
`invention was madeto 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
`
`' 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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`
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`IPR2020-01078
`Patent RE47,218 E
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`(2007). The question of obviousness is resolved on the basis of underlying .
`
`factual determinations including: (1) the scope and content ofthe prior art;
`
`(2) any differences between the claimed subject matter andthepriorart;
`
`(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).
`
`Level of Ordinary Skill in the Art, and
`B.
`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. degreein electrical or biomedical engineering or a related field with at
`
`least two years’ experience designing patient monitoring systems.”
`
`Pet. 9-10 (citing Ex. 1003 47 33-40). Also: “Less work experience may be
`
`compensated by a higherlevel 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 Ownerdescribes as
`
`“{rjelatively [[low.” PO Resp. 12; Ex. 2011 {J 18-19.
`Weconcludethe 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 Ownerurgesus to reject Dr. Yanulis’s testimony on behalf of
`Petitioner concerning what a POSITA would have understoodthe priorart to
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`disclose, and what a POSITA would have been motivated to do. See PO
`
`Resp. 12-14. Patent Ownerasserts Dr. Yanulis “admitted duringhis
`
`deposition that he applied the wrong legal standard” because he “basedhis
`opinions on how hepersonally interpreted the references, rather than what a
`
`[POSITA] would have understood.” Jd. at 12-13 (citing Ex. 2014,
`
`55:11-18, 57:26, 136:8-9). Patent Ownerexplains: “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
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`is therefore “irrelevant.” Jd. at 13-14 (emphasis by Patent Owner)(citing
`
`35 U.S.C. § 103; KSR, 550 U.S. at 420 (“The questionis .
`
`.
`
`. whether the
`
`combination was obviousto a person with ordinary skill in the art.”)).
`
`Petitioner replies that Dr. Yanulis applied the correct legal standard,
`
`because “he viewedtheprior art and the [’218] patent from the perspective
`
`of a [POSITA].” Pet. Reply 1-2 (citing Ex. 1003 33). Petitionerasserts it
`
`is not unusual for an expert witness such as Dr. Yanulis to have “credentials
`
`additional to those of a [POSITA].” /d. (citing Ex. 1003 {J 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 4 33. His declarationalso statcs that in
`
`2010 Dr. Yanulis “had 27 years of experiencein this field and was a person
`
`having ordinary skill in the art.” Jd. Further, Dr. Yanulis concludesheis
`
`“able to read and understandthe claims and specifications ofthe prior art
`
`and the [’218] patentin the light that a [POSITA] would read and understand
`
`10
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`them,” and sets forth the POSITA level we have adopted above. Jd.
`
`{7 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 knownand done in 2010, rather than what
`
`Dr. Yanulis personally would have known anddonein 2010.
`
`In the deposition testimony cited by Patent Owner, Dr. Yanulis was
`
`asked “I think you mentionedin your declaration or elsewhere you have had
`
`several decades ofexperiencein 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.” /d. 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 donein 2010. Dr. Yanulis did not state that
`
`his patentability opinions are premised on what he personally would have
`
`knownand 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 ofexperience as of the priority date of
`
`[the °218] patent?” Jd. 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.” Jd. 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 Bockpatent, but in the priorart[.]” Jd. at 57:2-6.
`
`.
`
`11
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`IPR2020-01078
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`Wedisagree with Patent Owner’s characterization ofthis testimonyas
`establishing that Dr. Yanulis’s patentability opinions are premised on what
`he personally would have known and done in 2010. Instead, Dr. Yanulis
`acknowledgedthat he personally had decades of experiencein the pertinent
`field, and then testified that such extensive experience (whichis not required
`for a POSITA)is not needed to understand Bockandtheotherpriorart at
`issue in this proceeding. See id. at 56:12—57:6. Thus, as with Dr. Yanulis’s
`declaration, his deposition testimony wasthat 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 priorart,” and “I wasjust
`reviewing based on mydefinition 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 appliedthe correct legal
`standardfor obviousness, by opining as to what a POSITA would have
`
`knownand donein 2010.
`
`C.
`
`Claim Construction
`
`Weinterpret 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
`
`12
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`IPR2020-01078
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`meaning of such claim as understood by oneof ordinary skill in the art and
`
`the prosecution history pertaining to the patent.” Jd.
`
`Weconstrue two aspects of claim 1, and then briefly address similar
`
`limitations in claims 8 and 12.
`
`Claim 1:
`1.
`“at least one oxygen saturation value, ”
`“the at least one oxygen saturation value,” and
`“the atleastfirst oxygen saturation value”
`
`Claim 1 recites, in limitation 1(e), “at least one oxygen saturation
`
`value obtained overthefirst 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 valueless than the at
`
`least one oxygen saturation value and greater than a lowerlimit and at an
`
`offset from the at least one oxygen saturation value, wherein the offset is
`
`diminished as a difference betweenthe atleastfirst oxygen saturation value
`
`and the lowerlimit diminishes.” Jd. at 14:16—30 (italicized and underlined
`
`emphasesadded).
`
`In the Institution Decision, we preliminarily construed these
`
`limitations sua sponte. See Inst. Dec. 18-23. Wealso “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.” Jd. at 23. Patent Owneracceptedthis 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.
`
`Wenowrevisit our preliminary construction of these limitations, based on a
`
`full record.
`
`13
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`IPR2020-01078
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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 wecontinue 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 concludedthat “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 derivedfrom the
`
`patient data (suchas 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 .
`measured parameter values.” Id.
`
`.
`
`. a value derived from the
`
`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 counselstated:
`
`“T 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. Jd. at 12:23-13:1
`
`14
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`(emphases added). Thus, Petitioner’s position is that all of the oxygen
`saturation valuesrecited in limitations 1(e) and 1(g) refer to “measured
`
`patient value[s],” not to other values derived from measuredpatient 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 valueorthe 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”).
`
`|
`
`Uponreview ofthe foregoing, and based on the agreementof the
`
`parties in this regard, we construeall 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 overa first period of time such as segment 620
`
`over time t). The at least one valuerecited in limitation 1(g) is obtained over
`
`a second period of time, following the first period of time, such as
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`segment 630 over time t7. We do not construe the oxygen saturation values
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`recited in limitation 1(g) to refer to a value derived from the patient data,
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`such as baselines B.
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`Claim 1:
`2.
`“one or more hardware processors configured to... trigger a second alarm
`based on [a measured oxygen saturation value] exceeding the second alarm
`threshold”’
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`Limitation 1(i) recites a processor “configuredto .
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`.
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`. trigger a second
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`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.”
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`Ex. 1001, 14:1-3, 14:34-40 (emphases added).
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`a)
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`The Institution Decision’s Preliminary Construction ofLimitation 1 (i)
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`In the Institution Decision, we preliminarily construed limitation 1(i)
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`sua sponte. See Inst. Dec. 18, 23-24. “[W]e conclude[d] that an oxygen
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`saturation value exceeding the second alarm threshold must be one condition
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`that is satisfied for the alarm to be ‘triggered .
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`.
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`. based on’ this condition in
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`limitation 1(i).” Jd. at 24. We further concluded “claim 1 is open to
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`requiring additional conditions to be satisfied for the alarm to be triggered,”
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`with the ’218 patent disclosing a time delay condition as one example. Id.
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`at 23-24 (citing Ex. 1001, 2:54~3:1 (Fig. 1), 6:35-41 (Fig. 4A), 7:40-8:6
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`(Fig. 6), 14:58-62 (claim 5)).
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`This construction of limitation 1(i) was a significant factor in our
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`determination, at the institution stage, that Petitioner had sufficiently
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`established Bock discloses limitation 1(i) to justify institution of review,
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`over objections made in Patent Owner’s Preliminary Response. Seeid.
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`at 39-41.
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`b)
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`Patent Owner’s Post-Institution Construction ofLimitation 1 (i)
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`Patent Ownerarguesthe Institution Decision construed limitation 1(i)
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`too broadly, and pursuant to a correct and narrower claim construction, Bock
`dues not disclose limitation 1(i). See PO Resp. 2-3, 15-28.
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`Patent Ownerasserts limitation 1(i) “requires that exceeding the
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`oxygen saturation value identified as the second alarm thresholdtriggers the
`alarm (optionally in combination with other non-oxygensaturation value
`conditions).” Jd. at 15; Ex. 2011 9] 47-48. A time delay is one example of
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`the other non-oxygen saturation value conditions permitted by this
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`construction. See PO Resp. 16, 26; Sur-reply 2; Ex. 2011 9 48. Thecritical
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`difference between Patent Owner’s construction andthe Institution
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`Decision’s preliminary construction is that, per Patent Owner, the other
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`conditions cannot be further oxygen saturation threshold values. See PO
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`Resp. 15, 18 (arguing limitation 1(i) “should not be construed to encompass
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`a system that triggers an alarm only ifthe patient’s oxygen saturation
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`exceeds a value that is more extreme than the purported ‘second alarm
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`threshold” (emphasis added)); Ex. 2011 4] 47-53. Patent Owner’s
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`construction would differentiate claim 1 from Bock, because as discussed in
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`Section III.D.1 below, Bockstriggers an alarm only if the patient’s oxygen
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`saturation firstly exceeds tracking threshold 314—-whichPetitioner equates
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`to the second alarm threshold of limitation 1(i}—and then secondly exceeds
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`alarm limit 316. See PO Resp. 16-17, 20-21; Ex. 2011 ff 29-30, 36-37.
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`Concerning the claim language, Patent Ownerarguesthe Institution
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`Decision “construed the phrase ‘triggered .. . based on. .
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`. exceeding’ but
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`did not construe the phrase ‘second alarm threshold.’” PO Resp. 16, 18.
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`Patent Ownerconstrues “second alarm threshold” to mean “the most
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`extreme (lowest) oxygen saturation value that must be exceededto trigger
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`the second alarm.” Jd. at 22; Sur-reply 3—4; Ex. 201147-53. Patent
`
`Owner’s view ofthe claim languageis 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
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`would be eliminating and replacingit,” and further “[i]f exceeding an
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`oxygen saturation value cannottrigger an alarm, then that oxygen saturation
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`value cannot be the claimed ‘second alarm threshold.’” PO Resp. 17 (citing
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`Ex. 2011 Ff 47-48, 54-58, 63); id. at 18-19, 22—23; Sur-reply 2-3, 5 (citing
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`Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc., 853 F.3d 1272, 1288 n.10
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`(Fed. Cir. 2017), as indicating “‘it is ‘highly disfavored’ to construe claim
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`terms in a way that a phraseor limitation is rendered meaningless”). Patent
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`Ownercites dictionary definitions that “define ‘threshold’ using definite
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`articles” in support. PO Resp. 21 (citing Exs. 2012 and 2013); Ex. 2011
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`q 52.
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`Claim 5 depends from claim 1 to add that the processor“wait[s] for a
`time delay priorto the triggering of the second alarm.” Ex. 1001, 14:58—62.
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`Patent Ownercontends claim 5 doesnotjustify the Institution Decision’s
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`preliminary construction. See PO Resp. 26—28; Ex. 2011 ff 54-64. Patent
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`Ownerargues“[a] time-delay condition is distinct from an additional
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`oxygen saturation value-measurementcondition,” so the addition of a time
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`delay is consistent with Patent Owner’s claim construction. PO Resp.
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`26-27; Ex. 2011 F§ 61-62. Patent Ownerasserts the Institution Decision’s
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`preliminary construction would improperly “subsumeor obviate the oxygen
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`saturation value-measurementcondition” in claim 1, renderingit
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`“meaningless,” based on the unrelated time delay condition in claim 5. PO
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`Resp. 26-27; Sur-reply 5-6; Ex. 2011 4] 61-62. Patent Ownerprovides a
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`Venndiagram to illustrate this contention. PO Resp. 27-28; Ex. 2011 § 63.
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`Turning to the ’218 patent specification, Patent Ownerasserts “each
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`description of ‘alarm threshold’ .
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`.
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`. refers to the most extreme value that
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`must be exceededto trigger the alarm.” PO Resp.19; Ex. 2011 ff] 49-51,
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`59-61. Patent Ownercites several specification descriptions of alarm
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`thresholds, including the adaptive alarm threshold AT, as supporting this
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`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
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`Owneralso asserts the ’218 patent’s usage of the claim phrase “based on”
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`and the similar phrase “based upon”is consistent with and confirmsPatent
`Owner’s proposed construction oflimitation 1(i). Jd. at 23-24 (citing
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`Ex. 1001, code (57), 5:5—7); Sur-reply 6; Ex. 2011 4§ 59-60. Patent Owner
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`cites Wisconsin Alumni Research Foundation v. Apple Inc., 905 F.3d 1341,
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`1351-52 (Fed. Cir. 2018), as “rejecting a proposed construction that would
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`improperly ‘expand the scope of the claims far beyond anything described in
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`the specification.’” PO Resp. 26.
`Patent Owneradditionally contends Petitioner’s witness Dr. Yanulis
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`agrees with Patent Owner’s claim construction. See id. at 21-22 (citing
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`Ex. 1003 9] 26-27); id. at 24-25(citing Ex. 2014, 192:3-9); Sur-reply 4-5.
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`c)
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` Petitioner’s Post-Institution Construction ofLimitation 1(i)
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`Petitioner agrees with the Institution Decision’s preliminary
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`construction of limitation 1(i). See Pet. Reply 2-10. Thus, Petitioner
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`contendsthis limitation should be construed to mean “exceeding the second
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`alarm threshold is at least one condition required to trigger an alarm.” Id.
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`at 3.
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`Considering the claim language,Petitioner argues Patent Owner’s
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`construction “is improperly restrictive.” Jd. at 3, 8. According to Petitioner,
`“construing claim language to exclude elements is disfavored in the absence
`of support ‘in the wordsofthe claim’ or through an ‘express disclaimer or
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`independent lexicographyin the written description that would justify
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`adding that negative limitation.’” Jd. at 3 n.1 (citing Omega Eng’g, Inc. v.
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`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
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`Owner’s position. Jd. at 3-4 (“Had the patentee intended the alarm to be
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`triggered by a narrowerset of conditions, it could have so stated[.]”);
`Ex. 104051-53. Petitioner cites a dictionary definition of the term “base
`on” as meaning “to use particular ideas or facts” (plural) to make a decision,
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`as “refut[ing] Patent Owner’s position that ‘based on’ meansthat other
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`oxygen saturation conditions cannot be included.” Pet. Reply 5 (citing
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`Ex. 1043); Ex. 1040 952. Petitioner cites two District Court decisionsthat,
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`Petitioner asserts, construed the claim phrase “based on”to be “an
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`open-ended term.” Pet. Reply 6—7 (citing Intellectual Ventures II LLCv.
`Sprint Spectrum L.P., No. 2:17-cv-662-JTG-RSP, 2018 WL 6018625, at *16
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`(E.D. Tex. Nov. 16, 2018); Apple Inc. v. Motorola, Inc., No. 1:11-cv-08540,
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`2012 WL 12537293, at *9 (N.D.Ill. Mar. 19, 2012)).
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`Considering the ’218 patent specification, Petitioner asserts the
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`patent’s usage of the term “based on”supports Petitioner’s construction.
`Pet. Reply 5 (citing Ex. 1001, code (57)); Ex. 1040 451. Also according to
`Petitioner, the ’218 patent’s disclosure that “the alarm is triggered after
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`falling below the adaptive threshold and remaining below the adaptive
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`threshold after a time delay” further supports Petitioner’s construction. Pet.
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`Reply 4-6 (emphasisby Petitioner) (citing Ex. 1001, 6:35-44, 9:12—20,
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`11:18-32, claims 5-6); Ex. 1040 {] 54-57.
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`Petitioner further asserts “the result of [Patent Owner’s] proposed
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`construction is nonsensical,” because it would defeat the ’218 patent’s
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`purpose of addressing non-actionable alarms. Pet. Reply 8. Petitioner
`reasons that, when a time delay is implemented as expressly contemplated in
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`the ’218 patent, and after the time delay period begins at the momentthe
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`patient’s measured oxygen saturation value exceeds an alarm threshold,
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`“commonsense dictates that the system rechecks the patient’s oxygen
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`saturation” during the time delay period. /d. at 8-9 (emphasis by Petitioner);
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`Ex. 1040 Jf 54-55. Otherwise, according to Petitioner, “[i]f the alarm
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`simplytriggered at the end of the delay without rechecking oxygen
`saturation values” per Patent Owner’s construction, “then the purposeofthe
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`delay is entirely defeated” because “nuisance alarms would not be
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`prevented.” Pet. Reply 9 (emphasis by Petitioner); Ex. 1040 ff 56-57.
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`Peti