Trials@uspto.gov
`571-272-7822
`
`Paper 41
`Date: November 19, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SOTERA WIRELESS, INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`IPR2020-01019
`Patent RE47,353 E
`
`
`
`
`
`
`
`
`
`Before JOSIAH C. COCKS, JENNIFER MEYER CHAGNON, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`CHAGNON, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`Dismissing Petitioner’s Motion to Exclude
`37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`571-272-7822
`
`Paper 41
`Date: November 19, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SOTERA WIRELESS, INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`IPR2020-01019
`Patent RE47,353 E
`
`
`
`
`
`
`
`
`
`Before JOSIAH C. COCKS, JENNIFER MEYER CHAGNON, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`CHAGNON, Administrative Patent Judge.
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`Dismissing Petitioner’s Motion to Exclude
`37 C.F.R. § 42.64
`
`
`
`
`
`
`
`
`
`IPR2020-01019
`Patent RE47,353 E
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Sotera Wireless, Inc. (“Petitioner”)1 filed a Petition requesting inter
`
`partes review of claims 1–25 (“the challenged claims”) of U.S. Patent
`
`No. RE47,353 E (Ex. 1001, “the RE353 patent”). Paper 1 (“Pet.”). Masimo
`
`Corporation (“Patent Owner”) filed a Preliminary Response. Paper 7. We
`
`instituted an inter partes review of all challenged claims 1–26 on all grounds
`
`of unpatentability, pursuant to 35 U.S.C. § 314. Paper 12 (“Inst. Dec.”).2
`
`After institution, Patent Owner filed a Response (Paper 24,
`
`“PO Resp.”) to the Petition, Petitioner filed a Reply (Paper 27, “Pet.
`
`Reply”), and Patent Owner filed a Sur-reply (Paper 31, “PO Sur-reply”).
`
`Additionally, Petitioner filed a Motion to Exclude certain deposition
`
`testimony (Paper 35, “MTE”), Patent Owner filed an Opposition (Paper 36),
`
`and Petitioner filed a Reply (Paper 37). An oral hearing was held on
`
`September 8, 2021, and a transcript of the hearing is included in the record.
`
`Paper 40 (“Tr.”).
`
`We issue this Final Written Decision pursuant to 35 U.S.C. § 318(a)
`
`and 37 C.F.R. § 42.73. For the reasons set forth below, Petitioner has met
`
`its burden of showing, by a preponderance of the evidence, that challenged
`
`claims 1–25 of the RE353 patent are unpatentable.
`
`
`1 Petitioner identifies Sotera Wireless, Inc. and Hon Hai Precision Industry
`Co., Ltd. (“Hon Hai”) as real parties-in-interest to this proceeding. Pet. 1.
`Petitioner states that Hon Hai is named as a real party-in-interest due to its
`involvement in a related proceeding. Id.
`2 To address institution considerations under 35 U.S.C. § 314(a), and with
`our authorization, Petitioner filed a Preliminary Reply (Paper 10) and Patent
`Owner filed a Preliminary Sur-reply (Paper 11). We do not refer to either
`paper in this Final Written Decision.
`
`2
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`IPR2020-01019
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`B. Related Proceedings
`
`The parties identify Masimo Corp. v. Sotera Wireless, Inc., Case
`
`No. 3:19-cv-01100-BAS-NLS (S.D. Cal.) as a related matter involving the
`
`RE353 patent. Pet. 2; Paper 4, 1.
`
`Patent Owner identifies the following inter partes review proceedings,
`
`involving patents related to the RE353 patent and which are asserted in the
`
`related district court matter:
`
`IPR2020-00912, challenging U.S. Patent No. 10,213,108 B2;
`
`IPR2020-00954, challenging U.S. Patent No. 9,788,735 B2;
`
`IPR2020-00967, challenging U.S. Patent No. RE47,244 E;
`
`IPR2020-01015, challenging U.S. Patent No. 9,795,300 B2;
`
`IPR2020-01033, challenging U.S. Patent No. RE47,249 E;
`
`IPR2020-01054, challenging U.S. Patent No. 9,872,623 B2;
`
`IPR2020-01078, challenging U.S. Patent No. RE47,218 E; and
`
`IPR2020-01082, challenging U.S. Patent No. 10,255,994 (institution
`
`denied).
`
`Paper 4, 2.
`
`Patent Owner further identifies various applications that claim priority
`
`to, or share a priority claim with, the RE353 patent. Id. at 1.
`
`C. The RE353 Patent
`
`The RE353 patent, titled “Alarm Suspend System,” was filed May 1,
`
`2017, and issued on April 16, 2019. Ex. 1001, codes (22), (45), (54). The
`
`3
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`Patent RE47,353 E
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`RE353 patent was filed as a reissue application of U.S. Patent No.
`
`9,153,121. Id. at code (64).3
`
`The RE353 patent describes a physiological measurement system that
`
`utilizes an alarm suspend system. Id. at 4:25–26. The disclosed system
`
`includes physiological monitor 101 and noninvasive sensor 105, which
`
`measures, e.g., pulse oximetry parameters, carboxyhemoglobin,
`
`methemoglobin, and/or total hemoglobin. Id. at 4:25–36, Fig. 1. The
`
`monitor may include a display, touch keys, and controls including “an alarm
`
`silence button [] that is pressed to temporarily suspend out-of-limit
`
`parameter alarms and system alarms, such as low battery.” Id. at 4:37–48.
`
`The alarm suspend system both prevents unnecessary disturbances to
`
`patients and distractions to caregivers. Id. at 2:33–36. “Advantageously, an
`
`alarm suspend system provides a parameter-dependent variation in the alarm
`
`suspend duration, as described below, utilizing a common silence button or
`
`other suspend initiator.” Id. at 4:60–63. “The alarm suspend period is
`
`typically long enough to give a caregiver sufficient time to intervene with
`
`appropriate patient treatment yet short enough to ensure that patient health is
`
`not endangered if intervention is ineffective.” Id. at 2:38–42.
`
`
`3 The RE353 patent claims earliest priority through a series of continuation
`applications to Provisional application No. 61/084,615, filed on July 29,
`2008. Ex. 1001, codes (60), (63). The specific priority date of the
`challenged claims is not at issue in this proceeding, and we need not make
`any determination in this regard for purposes of this Decision.
`
`4
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`Figure 3 of the RE353 patent, reproduced below, illustrates a flow
`
`diagram of an alarm suspend system. Id. at 4:16–17.
`
`
`
`As shown in Figure 3, above, “[a]larm triggers include system failures 338
`
`and out-of-limit parameters 318.” Id. at 5:43–44. Out-of-limit parameters
`
`are identified by comparing measured parameters 312 to default or
`
`user-specified limits 314. Id. at 5:51–52. Out-of-limit condition 318
`
`triggers alarm 340 that can be suspended 328 by user-initiated silence
`
`request 322. Id. at 5:52–56. Suspend durations may vary depending on the
`
`parameter. Id. at 6:23–28. For example, “relatively slow treatment
`
`parameters, such as [methemoglobin (‘HbMet’)], [carboxyhemo-
`
`globin (‘HbCO’)], [total haemoglobin (‘Hbt’) and [Pleth Variability Index
`
`(‘PVi’)], are assigned relatively long suspend durations. Similarly,
`
`relatively fast treatment parameters, such as [oxygen saturation (‘SpO2’)]
`
`and [pulse rate (‘PR’)], are assigned relatively short suspend durations.” Id.
`
`at 6:28–33.
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`5
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`Figure 4, reproduced below, illustrates an alarm suspend “that
`
`operates independently for each measured parameter that can trigger an
`
`alarm.” Id. at 5:66–6:1.
`
`
`
`As shown in Figure 4, above, the alarm is initially off 410, and remains off
`
`so long as the measured parameter is within its set limits 412. Id. at 6:1–3.
`
`When a measured parameter becomes outside its set limit 414 (i.e., it is “out-
`
`of-limit”), the system triggers alarm 420. Id. at 6:1–4. A user may activate
`
`silence request 422 that suspends alarm 430, for example, by pressing the
`
`alarm silence button, which then suspends 430 the alarm for predetermined
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`6
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`duration 432. Id. at 6:5–10. The predetermined duration “may be a function
`
`of the out-of-limit parameter.” Id. at 5:60–61. When the predetermined
`
`duration expires, the alarm is activated until the triggering parameter is
`
`within limit 424 or the user again silences 422 the alarm. Id. at 6:10–14.
`
`“[A]larm suspend 430 deactivates if the measured parameter becomes within
`
`limits 438, such as when the patient condition improves, or if no
`
`physiological data is detected 439.” Id. at 6:14–17. Alternatively, alarm
`
`suspend override 436 reactivates alarm 420 when a measured parameter
`
`changes by a sufficient out-of-limit amount. Id. at 6:19–22.
`
`D. Illustrative Claim
`
`Of the challenged claims, claims 1, 13, and 18 are independent.
`
`Claims 2–12 and 23–25 depend from claim 1; claims 14–17 depend from
`
`claim 13; and claims 19–22 depend from claim 18. Independent claim 1 of
`
`the RE353 patent is reproduced below, and is illustrative of the challenged
`
`claims.4
`
`1. A physiological measurement system comprising:
`
`a noninvasive physiological sensor configured to be positioned
`on a patient and output a signal responsive to a physiological
`condition of the patient; and
`
`one or more processors in communication with the noninvasive
`physiological sensor, the one or more processors configured to
`electronically:
`
`
`4 The RE353 patent is a reissue patent. As is standard when printing the
`claims of a reissue patent, matter enclosed in heavy brackets [ ] was deleted
`from the original claims and matter printed in italics was added in the
`reissued claims. For convenience, we produce a clean version of reissued
`claim 1.
`
`7
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`
`process the signal to determine a measurement of a
`physiological parameter based at least in part upon the
`signal;
`
`determine that an alarm should be activated in response to
`the measurement of the physiological parameter satisfying
`an alarm activation threshold;
`
`determine that an alarm suspension should be initiated for
`a parameter-specific alarm suspension period of time
`corresponding
`to
`the physiological parameter,
`the
`parameter-specific alarm suspension period of time being
`one of at least a plurality of parameter-specific alarm
`suspension periods of time, the parameter-specific alarm
`suspension period of time being different from at least one
`other parameter-specific alarm suspension period of time
`corresponding
`to at
`least one other physiological
`parameter for which the one or more processors are
`configured to determine at least one measurement;
`
`suspend the alarm for the parameter-specific alarm
`suspension period of time; and
`
`the
`the measurement of
`the alarm when
`activate
`physiological parameter satisfies the alarm activation
`threshold after the parameter-specific alarm suspension
`period of time has passed.
`
`Ex. 1001, 7:39–8:14.
`
`E. Applied References and Evidence
`
`Petitioner relies on the following references in the asserted grounds.
`
`Pet. 5–8.
`
`Reference
`
`Issue Date/
`Publication Date
`
`Exhibit
`
`U.S. Patent No. 5,865,736 (“Baker-1”)
`
`Feb. 2, 1999
`
`Ex. 1005
`
`8
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`Reference
`
`Issue Date/
`Publication Date
`
`Exhibit
`
`U.S. Publication No. 2009/0247851 A1
`(“Batchelder”)
`
`Oct. 1, 2009
`
`Ex. 1006
`
`U.S. Patent No. 8,792,949 B2 (“Baker-2”)
`
`Jul. 29, 2014
`
`Ex. 1007
`
`U.S. Publication No. 2005/0038332 A1
`(“Saidara”)
`
`Feb. 17, 2005
`
`Ex. 1008
`
`U.S. Publication No. 2003/0135087 A1
`(“Hickle”)
`
`Jul. 17, 2003
`
`Ex. 1009
`
`S. Malangi, Simulation and mathematical
`notation of alarms unit for computer
`assisted resuscitation algorithm, New
`Jersey Institute of Technology, Theses
`526, (2003) (“Malangi”)
`
`Jul. 12, 2004
`
`Ex. 1010
`
`Petitioner also submits the Declaration of George E. Yanulis, EngD
`
`(Ex. 1003) and the Declaration of Bryan Bergeron, MD (Ex. 1040). Patent
`
`Owner submits the Declaration of Jack Goldberg (Ex. 2011).
`
`The parties also rely upon deposition testimony of Dr. Yanulis
`
`(Ex. 2017 (Feb. 4, 2021, deposition); Ex. 2018 (Feb. 5, 2021, deposition);
`
`see also Exs. 2025–2026 (errata)), Dr. Bergeron (Ex. 2022 (June 24, 2021,
`
`deposition)), and Mr. Goldberg (Ex. 1042 (April 13, 2021, deposition);
`
`Ex. 1043 (April 14, 2021, deposition)).
`
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`F. Asserted Grounds of Unpatentability
`
`We instituted an inter partes review based on the following grounds.
`
`Inst. Dec. 10–11, 52.
`
`Claim(s) Challenged
`
`35 U.S.C. § Reference(s)/Basis
`
`1, 6–8, 13, 14, 18, 19, 23–25 1035
`
`Baker-1
`
`103
`
`103
`
`103
`
`103
`
`103
`
`Baker-1, Batchelder
`
`Baker-1, Batchelder, Baker-2
`
`Baker-1, Batchelder, Baker-2,
`Hickle
`
`Saidara, Malangi
`
`Saidara, Malangi, Hickle
`
`1, 2, 6–9, 13–16, 18–25
`
`1, 2, 6–9, 13–15, 18–25
`
`3–5, 10–12, 16, 17
`
`1, 2, 6–9, 13–15, 18–25
`
`3–5, 10–12, 16, 17, 25
`
`II. ANALYSIS
`
`A. Legal Standards
`
`To prevail in its challenges to the patentability of the claims,
`
`Petitioner must demonstrate by a preponderance of the evidence that the
`
`challenged claims are unpatentable. 35 U.S.C. § 316(e). “In an [inter partes
`
`review], the petitioner has the burden from the onset to show with
`
`particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
`
`Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C.
`
`§ 312(a)(3) (requiring inter partes review petitions to identify “with
`
`particularity . . . the evidence that supports the grounds for the challenge to
`
`
`5 Because the application leading to the RE353 patent has an effective filing
`date before March 16, 2013, patentability is governed by the version of
`35 U.S.C. §§ 102 and 103 preceding the Leahy-Smith America Invents Act
`(“AIA”), Pub L. No. 112-29, 125 Stat. 284 (2011).
`
`10
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`each claim”)). This burden of persuasion never shifts to Patent Owner. See
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`
`(Fed. Cir. 2015) (discussing the burden of proof in inter partes review).
`
`A claim is unpatentable under 35 U.S.C. § 103(a) if “the differences
`
`between the subject matter sought to be patented and the prior art are such
`
`that the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which said
`
`subject matter pertains.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
`
`(2007). The question of obviousness is resolved on the basis of underlying
`
`factual determinations including: (1) the scope and content of the prior art;
`
`(2) any differences between the claimed subject matter and the prior art;
`
`(3) the level of ordinary skill in the art; and (4) objective evidence of
`
`nonobviousness.6 Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`Consideration of the Graham factors “helps inform the ultimate obviousness
`
`determination.” Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1048
`
`(Fed. Cir. 2016) (en banc).
`
`An obviousness analysis “need not seek out precise teachings directed
`
`to the specific subject matter of the challenged claim, for a court can take
`
`account of the inferences and creative steps that a person of ordinary skill in
`
`the art would employ.” KSR, 550 U.S. at 418; accord In re Translogic
`
`Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). However, Petitioner
`
`cannot satisfy its burden of proving obviousness by employing “mere
`
`conclusory statements,” but “must instead articulate specific reasoning,
`
`based on evidence of record” to support an obviousness determination. In re
`
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380–81 (Fed. Cir. 2016).
`
`
`6 Patent Owner has not presented objective evidence of non-obviousness.
`
`11
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`Petitioner also must articulate a reason why a person of ordinary skill in the
`
`art would have combined the prior art references. In re NuVasive, 842 F.3d
`
`1376, 1382 (Fed. Cir. 2016).
`
`At this final stage, we determine whether a preponderance of the
`
`evidence of record shows that the challenged claims would have been
`
`rendered obvious in view of the asserted prior art. We analyze the asserted
`
`grounds of unpatentability in accordance with these principles.
`
`B. Level of Ordinary Skill in the Art
`
`We review the grounds of unpatentability in view of the
`
`understanding of a person of ordinary skill in the art at the time of the
`
`invention. Graham, 383 U.S. at 17. Petitioner contends that a person
`
`having ordinary skill in the art “would have been a person with at least a
`
`B.S. degree in electrical or biomedical engineering or a related field with at
`
`least two years’ experience designing patient monitoring systems,” wherein
`
`“[l]ess work experience may be compensated by a higher level of education,
`
`and vice versa.” Pet. 13 (citing Ex. 1003 ¶¶ 33–41); see Ex. 1040 ¶ 28.
`
`Patent Owner applies the level of ordinary skill in the art identified by
`
`Petitioner. PO Resp. 8 n.5 (citing Ex. 2011 ¶¶ 18–19).
`
`We adopt Petitioner’s assessment, which appears consistent with the
`
`level of skill reflected in the Specification and prior art.
`
`C. Claim Construction
`
`For this inter partes review proceeding, claim terms
`
`shall be construed using the same claim construction
`standard that would be used to construe the claim in a civil action
`under 35 U.S.C. [§] 282(b), including construing the claim in
`accordance with the ordinary and customary meaning of such
`
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`claim as understood by one of ordinary skill in the art and the
`prosecution history pertaining to the patent.
`
`37 C.F.R. § 42.100(b) (2019).7
`
`Under the standard set forth in Phillips v. AWH Corp., 415 F.3d 1303,
`
`1312–19 (Fed. Cir. 2005) (en banc), claim terms are given their ordinary and
`
`customary meaning, as would have been understood by a person of ordinary
`
`skill in the art at the time of the invention, in light of the language of the
`
`claims, the specification, and the prosecution history of record. See Thorner
`
`v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012).
`
`We construe terms only to the extent necessary to resolve the controversy.
`
`Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d
`
`1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g,
`
`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).8
`
`1. Overview of the Claim Construction Dispute
`
`Independent claim 1 recites, inter alia, “determin[ing] that an alarm
`
`should be activated in response to the measurement of the physiological
`
`parameter satisfies an alarm activation threshold,” “determin[ing] that an
`
`alarm suspension should be initiated for a parameter-specific alarm
`
`
`7 Although our rules state that “[a]ny prior claim construction determination
`concerning a term of the claim in a civil action, or a proceeding before the
`International Trade Commission, that is timely made of record in the inter
`partes review proceeding will be considered” (37 C.F.R. § 42.100(b)), no
`such construction is of record in this proceeding.
`8 In our Institution Decision, we preliminary determined that the claims do
`not require a “predetermined, fixed, or pre-set” period of time. See Inst.
`Dec. 25–26. Resolution of this issue, however, is not necessary to resolve
`the controversy before us. See, e.g., PO Resp. 64–65; see Nidec, 868 F.3d at
`1017.
`
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`suspension period of time,” and “suspend[ing] the alarm for the parameter-
`
`specific alarm suspension period of time.” Ex. 1001, 7:39–8:13 (emphases
`
`added). Independent claim 13 includes similar limitations. Id. at 9:38–
`
`10:19. Independent claim 18 recites “determin[ing] that a first alarm
`
`suspension should be initiated for a first parameter-specific alarm
`
`suspension period of time,” “determin[ing] that the first measurement [of the
`
`first measured physiological parameter] satisfies the first alarm activation
`
`threshold,” and “suspend[ing] activation of a first alarm for the first
`
`parameter-specific alarm suspension period of time.” Id. at 10:42–11:12
`
`(emphases added).
`
`The arguments and evidence before us raise the question of whether
`
`the claims, when considered as a whole, require suspending activated alarms
`
`only (i.e., post-alarm suspension), or whether the claims also encompass
`
`delaying initial alarm activation (i.e., pre-alarm delays). See Pet. Reply 2–3.
`
`The Petition presents different grounds to account for these alternate
`
`constructions. Pet. 14–15. Specifically, the Baker-1 grounds “are directed
`
`to a construction encompassing delays before an alarm is activated (i.e.,
`
`pre-alarm delays),” and the Saidara grounds “are directed to temporary
`
`suspension of active alarms (i.e., post-alarm suspensions).” Id. Thus,
`
`resolution of this question is dispositive as to certain asserted grounds of
`
`unpatentability.
`
`a) “alarm activation threshold”
`
`Claim 1 recites “determin[ing] that an alarm should be activated in
`
`response to the measurement of the physiological parameter satisfies an
`
`alarm activation threshold.” Ex. 1001, 7:54–56; see also id. at 9:59–61
`
`(similar in claim 13); id. at 11:5–6 (similar in claim 18).
`
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`In the Institution Decision, in addressing Patent Owner’s arguments
`
`distinguishing the asserted art, we preliminarily were “not persuaded that
`
`determining that an alarm should be activated in response to satisfying an
`
`alarm activation threshold requires actual activation (or indication) of an
`
`alarm,” i.e., triggering an audible or visual alarm indicator. Inst. Dec. 27
`
`(emphasis in Institution Decision); see id. at 26–28.
`
`After institution, Petitioner argues that “[t]he plain meaning of ‘alarm
`
`activation threshold’ necessarily requires the determination that a parameter
`
`exceeds a threshold automatically results in alarm activation.” Pet. Reply 4
`
`(citing Ex. 1040 ¶ 70) (emphasis added).
`
`In the Sur-reply, Patent Owner agrees with our initial determination,
`
`asserting that “meeting the alarm activation threshold is a separate
`
`requirement from activating the alarm.” PO Sur-reply 5–6.
`
`b) “parameter-specific alarm suspension period of time”
`
`Claim 1 recites “determin[ing] that an alarm suspension should be
`
`initiated for a parameter-specific alarm suspension period of time
`
`corresponding to the physiological parameter,” and “suspend[ing] the alarm
`
`for the parameter-specific suspension period of time.” Ex. 1001, 7:57–60,
`
`8:8–9; see also id. at 10:56–62, 11:10–12 (similar in claim 18); id. at 9:51–
`
`56, 10:11–13 (claim 13 recites storing a first parameter-specific alarm
`
`suspension period of time corresponding to a first physiological parameter,
`
`and suspending the alarm for the first parameter-specific alarm suspension
`
`period of time).
`
`Petitioner contends that the claimed “parameter-specific alarm
`
`suspension period of time,” “must be interpreted in light of the Specification,
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`which only teaches suspension of active alarms,” i.e., alarms that have
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`already indicated an alarm condition in which a parameter exceeds an alarm
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`activation threshold by, e.g., emitting audible or visual indicators. Pet. 14
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`(citing Ex. 1003 ¶ 45). Petitioner also contends that during prosecution of
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`the application that issued as the RE353 patent, the Examiner “rejected the
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`claims in view of prior art that teaches suspending active alarms.” Id. (citing
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`Ex. 1003 ¶¶ 30, 45; Pet. 10–12).
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`However, Petitioner notes that, in the related district court proceeding
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`(see supra § I.B), Patent Owner asserted that this claim language is satisfied
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`by systems in which activation of an alarm, e.g., the emission of audible or
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`visual indicators, is delayed until a measured parameter exceeds a threshold
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`for a predetermined period of time. Pet. 13–14. In light of these arguments,
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`Petitioner presumes that Patent Owner’s construction of “alarm suspension
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`period of time” encompasses a “delay [that] is part of the alarm threshold,”
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`or in other words, “if the parameter returns to a normal range within the
`
`‘annunciation delay’ period, the alarm never activates.” Id. at 14 (citing
`
`Ex. 1003 ¶ 44).
`
`In our Institution Decision, we did not expressly construe “alarm
`
`suspension period of time,” and we applied the plain and ordinary meaning
`
`of the claim language for purposes of institution. See Inst. Dec. 23–25. In
`
`applying the prior art to the claims, we determined on the preliminary record
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`that Baker-1’s pre-alarm delay provided a sufficient showing of this claim
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`limitation for purposes of institution. See id. at 39–43. We specifically
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`provided instruction to the parties, however, that “[d]uring trial, the parties
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`are encouraged to develop the record regarding the proper construction of
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`this phrase in light of the Specification.” Id. at 24–25.
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`After institution, Petitioner maintains its position that a “‘parameter-
`
`specific alarm suspension period of time’ is a time period in which an
`
`activated alarm is temporarily silenced or deactivated, [which is] the
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`specification’s only disclosure.” Pet. Reply 4 (citing Ex. 1001, 2:33–36,
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`3:1–2, 3:31–32, 3:58–60, 4:46–48, 4:58–60, 5:51–58, 6:3–9; Ex. 1003 ¶ 45;
`
`Ex. 1040 ¶ 71). Or, in other words, Petitioner maintains the position that the
`
`claims are limited to post-alarm suspensions, and do not encompass pre-
`
`alarm delays.
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`Despite our instruction to do so, Patent Owner does not address the
`
`construction of “alarm suspension period of time” in the Patent Owner
`
`Response.9 See generally PO Resp. Patent Owner instead asserts that
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`“[n]one of [its] arguments depend on a different pre-alarm/post-alarm
`
`construction,” and “the parties raise no patentability controversy regarding
`
`the pre-alarm or post-alarm claim scope.” PO Sur-reply 1. Patent Owner
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`contends that “[t]here’s no need to consider a narrow construction on which
`
`none of [Patent Owner’s] arguments depend.” Tr. 35:11–13; see id. at
`
`34:19–35:19; see also PO Sur-reply 1 (“The Board should not reach this
`
`construction issue.”).
`
`Nonetheless, for the first time, in the Sur-reply, Patent Owner argues
`
`that the Specification of the RE353 does not, in fact, support Petitioner’s
`
`proposed construction that limits the claims to only post-alarm suspensions,
`
`but rather supports its apparent contention that the claims also encompass
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`pre-alarm delays. See PO Sur-reply 2–6 (citing Ex. 1001, 3:58–4:9, 4:60–
`
`
`9 See Tr. 40:5–16 (Patent Owner’s counsel agreeing Patent Owner was on
`notice of the Board’s instruction to develop the record on this issue but,
`instead, concluded that “It’s not something that needs to be developed”); see
`also id. at 39:7–40:16 (larger discussion).
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`63, 5:60–65, 6:15–20, 6:38–41; Ex. 1042, 118:2–120:20; Ex. 2022, 22:13–
`
`23:2, 23:8–20, 65:20–66:6, 174:2–10).
`
`c) Explicit Construction is Appropriate
`
`Despite Patent Owner’s contention that we need not address this
`
`question of claim construction, the law is clear that obviousness under
`
`35 U.S.C. § 103 is a “two-step inquir[y].” Medichem, S.A. v. Rolabo, S.L.,
`
`353 F.3d 928, 933 (Fed. Cir. 2003); see also Tr. 65:5–16. The first step “is a
`
`proper construction of the claims. . . . The second step in the analys[i]s
`
`requires a comparison of the properly construed claim to the prior art.” Id.
`
`While it is also true that only those claim terms that are in controversy need
`
`to be construed, and only to the extent necessary to resolve the controversy,
`
`see Nidec, 868 F.3d at 1017, a party’s allegation that terms are not disputed,
`
`or that construction is unnecessary because resolution of a different issue
`
`may be dispositive, does not preclude construction. This is especially so
`
`where resolution of a particular claim construction issue also is dispositive to
`
`allegations of unpatentability. See Tr. 8:20–9:1 (Petitioner’s counsel
`
`indicating that if the Board agrees with Petitioner’s contention that “these
`
`patents are properly construed as not covering [pre-alarm] delays . . . then
`
`the grounds 1 through 4 [(i.e., the Baker-1 grounds)] are out. You would not
`
`have to decide grounds 1 through 4 if you decide our way” on the claim
`
`construction question.); id. at 35:3–6 (Patent Owner’s counsel noting that
`
`“[Patent Owner] has never disputed that the claims will cover both
`
`[pre-alarm delays and post-alarm suspensions] and in fact none of [Patent
`
`Owner’s] arguments depend on a narrower construction. Not a single page
`
`of [Patent Owner’s] briefs makes an argument based on the narrow
`
`construction.”); id. at 39:10–40:16 (Patent Owner’s counsel discussing the
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`strategic decision not to address the issue related to Petitioner’s proposed
`
`narrow construction).
`
`For purposes of this Decision, to resolve the issues raised by
`
`Petitioner’s asserted grounds, we construe “alarm activation threshold” and
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`“alarm suspension period of time” only to the extent that we find that the
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`claims, when considered as a whole, do not encompass pre-alarm delays.
`
`Our reasoning follows.
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`2. The Parties’ Reliance on the RE353 Specification
`
`Both Petitioner and Patent Owner contend that the Specification of the
`
`RE353 patent supports its respective position.
`
`a) Petitioner’s Position
`
`As Petitioner notes, “[n]either ‘alarm activation threshold’ nor ‘alarm
`
`suspension period of time’ appear in the specification” of the RE353 patent.
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`Pet. Reply 2.
`
`Petitioner contends that the Specification “only teaches suspension of
`
`active alarms.” Pet. 14 (citing Ex. 1003 ¶ 45); see also Ex. 1040 ¶ 63.
`
`According to Petitioner,
`
`The specification only describes a system that (1) compares a
`measured parameter to set limits; (2) automatically activates an
`alarm when the parameter is out-of-limits; (3) thereafter,
`suspends the activated alarm for a “parameter-specific” duration
`in response to a user request; and (4) “resumes,” “retriggers,” or
`“reactivates” the alarm after the suspension duration.
`
`Pet. Reply 2–3 (citing, inter alia, Ex. 1003 ¶¶ 21–25, 46; Ex. 1040 ¶ 64).
`
`Petitioner cites the Abstract in support of its claim construction
`
`position (see id. at 2–3), which teaches, “An alarm suspend system utilizes
`
`an alarm trigger responsive to physiological parameters and corresponding
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`limits on those parameters. . . . Audible and visual alarms respond to the
`
`alarm trigger. An alarm silence button is pressed to silence the audible
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`alarm for a predetermined suspend time.” Ex. 1001, code (57) (emphasis
`
`added).
`
`Petitioner also cites numerous portions of the RE353 Specification in
`
`support of its position that the claims are limited to suspensions of active
`
`alarms (see Pet. Reply 2–5). For example, Petitioner relies upon the
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`Specification’s disclosure that “alarms are triggered by out-of-limit
`
`parameters and system failures.” Ex. 1001, 2:18–19.
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`Petitioner also relies upon the Specification’s teachings that, when an
`
`active alarm is suspended by a user, it will remain suspended for a
`
`predetermined period of time but will be reactivated if the triggering
`
`condition persists. Id. at 2:33–38. Specifically, the Specification teaches
`
`that “[a]n audible alarm may be temporarily suspended by pressing an alarm
`
`silence button so as to prevent unnecessary disturbance to the patient and
`
`distraction of the caregiver. During alarm suspension, visual alarms remain
`
`active. If an alarm condition persists after a predetermined alarm suspend
`
`period, the audible alarm resumes.” Id. (emphasis added).
`
`The Specification further explains that the suspension period “is
`
`typically long enough to give a caregiver sufficient time to intervene with
`
`appropriate patient treatment yet short enough to ensure that patient health is
`
`not endangered if intervention is ineffective.” Id. at 2:38–42; see also id. at
`
`2:55–57 (“When patient treatment time exceeds the maximum alarm
`
`suspend period, an audible alarm will constantly reactivate.”); id. at 2:57–60
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`(“[A] single alarm suspend duration for all parameters is inadequate to cope
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`with the many different types of parameters measured by the advanced
`
`monitors.”).
`
`Petitioner additionally relies upon the following portions of the
`
`Specification, which are consistent with the disclosures discussed above; the
`
`cited portions of the Specification repeatedly describe that an alarm is
`
`automatically triggered when an alarm activation threshold is satisfied, the
`
`activated alarm may be suspended by a user, and the alarm will reactivate if
`
`the alarm activation threshold is still satisfied:
`
`One aspect of an alarm suspend system for silencing the
`alarms is an alarm trigger responsive to any of various
`parameters an
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