`US Patent No. RE47,249
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`Paper No. 37
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________
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`SOTERA WIRELESS, INC.
`Petitioner
`
`v.
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`MASIMO CORPORATION
`Patent Owner
`
`Case IPR2020-01033
`US Patent No. RE47,249
`_____________________
`
`Before JOSIAH C. COCKS, JENNIFER MEYER CHAGNON, and
`AMANDA F. WIEKER, Administrative Patent Judges.
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`__________________________________________________________________
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`PETITIONER’S DEMONSTRATIVES FOR ORAL ARGUMENT
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`Case No. IPR2020-01033
`Patent No. RE47,249
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`Pursuant to the July 28, 2021 Order Granting Requests for Oral Argument
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`(Paper 33) and 37 C.F.R. § 42.70(b), Petitioner Sotera Wireless, Inc. hereby files
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`its Demonstratives for use at Oral Argument, attached hereto.
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`Dated: September 2, 2021
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`Respectfully submitted,
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`By: /s/ Rudolph A. Telscher, Jr.
`Rudolph A. Telscher, Jr., Reg. No. 36,032
`Daisy Manning, Reg. No. 66,369
`Nathan P. Sportel, Reg. No. 67,980
`Jennifer E. Hoekel, Reg. No. 48,330
`HUSCH BLACKWELL LLP
`190 Carondelet Plaza, Suite 600
`St. Louis, MO 63105
`(314) 480-1500 Telephone
`(314) 480-1505 Facsimile
`PTAB-RTelscher@huschblackwell.com
`PTAB-DManning@huschblackwell.com
`Nathan.Sportel@huschblackwell.com
`PTAB-JHoekel@huschblackwell.com
`
`Attorneys for Petitioner
`Sotera Wireless, Inc.
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`1
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`Case No. IPR2020-01033
`Patent No. RE47,249
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this 2nd day of September 2021, the foregoing was
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`served via electronic mail to the attorneys of record for the RE249 patent at the
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`following address:
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`Stephen W. Larson (Reg. No. 69,133), 2swl@knobbe.com
`Jacob Peterson, (Reg. No. 65,096), 2jup@knobbe.com
`Irfan A. Lateef (Reg. No. 51,922), 2ial@knobbe.com
`Brian C. Claassen (Reg. No.63,051), 2bcc@knobbe.com
`Jarom D. Kelser (Reg. No. 57,046), 2jzk@knobbe.com
`Jeremiah S. Helm, Ph.D. (admitted pro hac vice) jeremiah.helm@knobbe.com
`SoteraIPR249@knobbe.com
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
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`By: /s/ Rudolph A. Telscher, Jr.
`Rudolph A. Telscher, Jr.
`Reg. No. 36,032
`Lead Counsel for Petitioner
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`Sotera Wireless, Inc.,
`Petitioner
`v.
`Masimo Corporation,
`Patent Owner
`
`Case Nos. IPR2020-00967, IPR2020-01019, IPR2020-01033
`U.S. Patent Nos. RE47,244, RE47,353, RE47,249
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`© 2021 Husch Blackwell LLP
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`
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`All Claims of the RE244, RE353, and
`RE249 Patents are Unpatentable
`
`•
`
`Like the original ‘121 patent, the RE244, RE353, and RE249 reissue patents only teach parameter-specific
`suspension of active alarms to allow sufficient time to treat an alarming condition.
`• The claims of the RE244, RE353, and RE249 patents encompass both predetermined delays and delays of
`unknown duration.
`• Parameter-specific alarm delays were well-known in the art to prevent false or nuisance alarms, and
`parameter-specific alarm suspensions were well-known to provide intermittent warnings of an alarm
`condition and to prevent subsequent alarms while an alarm condition is treated by a caregiver.
`• Baker-1 teaches all limitations of the independent claims under an improper construction covering pre-
`alarm delays.
`• Saidara and Malangi teach all limitations of the independent claims under a proper construction covering
`post-alarm suspensions.
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`Masimo’s Arguments are Unavailing
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`• Masimo urges the Board to construe the claims to cover undisclosed parameter-specific pre-alarm
`delays, rendering the stated purpose of the claimed inventions nonsensical.
`• Conversely, Masimo urges the Board to improperly import “predetermined” into the “periods of time”
`recited in the claims.
`• Masimo’s arguments against Baker-1 are premised on importation of “predetermined” into “periods of
`time.”
`• Masimo’s arguments against Saidara and Malangi are premised on a mischaracterization of the
`references and Sotera’s proposed combination.
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`The Challenged Patents
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`The Challenged Patents
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`• The RE244, RE353, and RE249 patents – titled “Alarm Suspend System” – are reissues of U.S.
`Patent No. 9,153,121 and filed years after Sotera’s accused system was on the market.
`Priority date of RE244, RE353, RE249 patents: July 29, 2008
`
`
`
`
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`‘121 patent: filed August 26, 2014; issued October 6, 2015
`
` RE244, RE353, RE249 patents: filed May 1, 2017; issued February 19, 2019 (RE244; RE249) and April 16, 2019 (RE353).
`• The specification and claims of the original ‘121 patent are directed to systems that monitor
`multiple physiological parameters that enable users to suspend active alarms for periods of
`time corresponding to the treatment time for a particular alarming physiological parameter.
`(EX1015, claims 1, 13, 18; EX1003, ¶¶ 26-28)
`
`Paper 1 (RE244), pp. 3-5, 10-12; Paper 1 (RE353), pp. 4-6, 10-12; Paper 1 (RE249), pp. 4-6, 10-12
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`The Specification of the Challenged Patents
`1. An alarm automatically activates when a physiological parameter
`measurement is outside of predetermined limits.
`
`EX1001 (RE244), 2:18-20
`
`EX1001 (RE244), 3:30-31
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`EX1001 (RE244), 4:42-46
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`EX1001 (RE244), 5:42-45
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`EX1001 (RE244), 5:51-53
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`EX1001 (RE244), 6:1-4
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`Paper 1 (RE244), pp. 8-10; Paper 1 (RE353), pp. 8-10; Paper 1 (RE249), pp. 8-10; Paper 28 (RE244), pp. 2-4; Paper 27 (RE353), pp. 2-5; Paper 26 (RE249), pp. 2-5.
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`The Specification of the Challenged Patents
`2. After an alarm activates, a user may temporarily silence the audible alarm by
`pressing an alarm silence button or initiating a silence request.
`
`EX1001 (RE244), 2:33-36
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`EX1001 (RE244), 3:1-2
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`EX1001 (RE244), 3:31-32
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`EX1001 (RE244), 4:58-60
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`EX1001 (RE244), 4:46-48
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`EX1001 (RE244), 5:53-56
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`EX1001 (RE244), 5:38-41
`EX1001 (RE244), 6:5-7
`Paper 1 (RE244), pp. 8-10; Paper 1 (RE353), pp. 8-10; Paper 1 (RE249), pp. 8-10; Paper 28 (RE244), pp. 2-4; Paper 27 (RE353), pp. 2-5; Paper 26 (RE249), pp. 2-5.
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`The Specification of the Challenged Patents
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`3. The alarm “resumes,” “retriggers,” or “reactivates” after the alarm
`suspension duration.*
`* If the parameter measurement changes during the alarm
`suspension by a sufficient out-of-limit amount, the alarm
`reactivates:
`
`EX1001 (RE244), 2:37-38
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`EX1001 (RE244), 3:4-6
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`EX1001 (RE244), 6:19-22
`* If the parameter measurement becomes within limits
`during the suspension, the alarm deactivates:
`
`EX1001 (RE244), 3:34-36
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`EX1001 (RE244), 6:14-16
`Paper 1 (RE244), pp. 8-10; Paper 1 (RE353), pp. 8-10; Paper 1 (RE249), pp. 8-10; Paper 28 (RE244), pp. 2-4; Paper 27 (RE353), pp. 2-5; Paper 26 (RE249), pp. 2-5.
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`The Specification of the Challenged Patents
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`• Figure 4 illustrates the alarm suspension system.
`EX1001.
`
`• An alarm is suspended (430) only after the alarm is
`turned “on” (420) as a result of an out-of-limit
`parameter (414) and in response to a “silence request”
`(422).
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`Paper 1 (RE244), p. 9; Paper 1 (RE353), pp. 9-10; Paper 1 (RE249), pp. 9-10.
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`The Specification of the Challenged Patents
`Alarm suspension times preferably correspond “to the relative length of time it
`takes for a person to respond to medical treatment for a parameter
`measurement outside of the predetermined limits.”
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`EX1001 (RE244), 2:38-42
`
`EX1001 (RE244), 2:61-67
`Paper 1 (RE244), pp. 8-9; Paper 1 (RE353), pp. 8-9; Paper 1 (RE249), p. 9; Paper 28 (RE244), pp. 1, 4; Paper 27 (RE353), pp. 1, 4; Paper 26 (RE249), pp. 1, 4-5.
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`EX1001 (RE244), 3:6-9
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`The Original ‘121 Patent and
`Reissued Claims
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`The Original ‘121 Patent
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`• The claims of the original ‘121 patent were consistent
`with the teachings of the specification.
`•
`EX1015, claims 1, 13, 18; see also EX1046, pp. 11-14.
`
`• Similarly, all prior family members require suspension
`or deactivation of an active alarm in response to a
`“silence request” or “alarm suspension indication,” or
`upon actuation of a “silence button.”
`•
`EX1012, EX1013, EX1014.
`
`Paper 1 (RE244), pp. 10-12; Paper 1 (RE353), pp. 10-12; Paper 1 (RE249), pp. 10-12; Paper 28 (RE244), pp. 4-5 n. 3; Paper 27 (RE353), pp. 5 n. 5; Paper 26 (RE249), pp. 5-6 n. 4.
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`Reissue Amendments to ‘121 Patent Claims
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`All claims of the RE244, RE353, and RE249 were amended to eliminate the following
`limitations:
`1.
`“receive, from a user, an indication of a parameter-specific alarm suspension period of time
`… selected from a one of a plurality … ”;
`“activate an alarm in response to determining that an alarm activation threshold has been
`satisfied by the physiological parameter measurement”;
`“receive an alarm suspension indication”;
`“in response to receiving the alarm suspension indication, suspend the alarm for the
`indicated parameter-specific alarm suspension period of time.”
`
`3.
`4.
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`2.
`
`EX1023, pp. 2-3, 5-6, 7-9; Paper 1 (RE244), p. 11; Paper 1 (RE353), p. 11; Paper 1 (RE249), pp. 11-12.
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`The Reissued Claims – RE244 Patent
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`• The RE244 patent claims were also amended
`to require “a parameter-specific delay or
`suspension period of time.”
`
`•
`
`Independent claim 1 requires the “parameter-
`specific delay or suspension period of time”
`be (1) one of a plurality; and (2) different from
`a second parameter-specific alarm delay or
`suspension period of time corresponding to a
`second physiological parameter.
`•
`Independent claims 13 and 18 only
`require limitation (2) above.
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`EX1023 (RE244), pp. 2-3, 5-6, 7-9; Paper 1
`(RE244), pp. 12.
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`
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`The Reissued Claims – RE353 Patent
`
`• The RE353 patent claims, like the ‘121
`patent, require “a parameter-specific
`suspension period of time.”
`
`•
`
`Independent claim 1 requires the
`“parameter-specific suspension period of
`time” be (1) one of a plurality; and (2)
`different from a second parameter-specific
`alarm suspension period of time
`corresponding to a second physiological
`parameter.
`•
`Independent claims 13 and 18 only
`require limitation (2) above.
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`EX1023 (RE353), pp. 2-3, 5-8; Paper 1
`(RE353), pp. 11-12.
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`
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`The Reissued Claims – RE249 Patent
`
`• The RE249 patent claims were also
`amended to require “a parameter-specific
`hold period of time.”
`
`•
`
`Independent claim 1 requires the
`“parameter-specific hold period of time”
`be (1) one of a plurality; and (2) different
`from a second parameter-specific alarm
`delay or suspension period of time
`corresponding to a second physiological
`parameter.
`•
`Independent claims 13 and 18 only
`require limitation (2) above.
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`EX1023 (RE249), pp. 2-3, 6, 7-8; Paper 1
`(RE249), pp. 11-12.
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`Claim Construction
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`Claim Construction
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`• “alarm delay or suspension period of time” (RE244)/
`“alarm suspension period of time” (RE353)/ “alarm hold period of time”
`(RE249).
` “alarm activation threshold” (RE244/RE353) and “activation threshold”/ “alarm
`condition” (RE249) are related to interpretation of these terms.
` The alarm delay, suspension, or hold periods of time do not have to be
`“predetermined.”
`
`Paper 1 (RE244), pp. 8-14; Paper 1 (RE353), pp. 8-14, ; Paper 1 (RE249), pp. 8-15; Paper 28 (RE244), pp. 2-8; Paper 27 (RE353), pp. 2-9; Paper 26 (RE249), pp. 2-9.
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`Claim Construction
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`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• The intrinsic record compels a construction of these terms as “time periods in
`which an activated alarm is temporarily silenced or deactivated.”
` None of these terms appear in the specification.
` The specification only teaches parameter-specific suspensions of active alarms.
` The original ‘121 patent claims were limited to suspensions of active alarms.
` The Examiner interpreted the claims as directed to suspensions of active alarms.
` The stated purpose of the RE244, RE353, and RE249 patents is nonsensical if construed to cover pre-
`alarm delays.
`
`Paper 1 (RE244), pp. 8-14; Paper 1 (RE353), pp. 8-14; Paper 1 (RE249), pp. 8-15; Paper 28 (RE244), pp. 1-4; Paper 27 (RE353), pp. 1-5; Paper 26 (RE249), pp. 1-5.
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`Claim Construction
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`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• The specification only discloses 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” or “deactivates” the
`alarm for a “parameter-specific” duration in
`response to a user request; and
`(4) “resumes,” “retriggers,” or “reactivates” the
`alarm after the suspension duration.
`EX1001, Abstract, 2:18-20, 2:33-42, 2:55-3:6, 3:28-36, 3:58-65, 4:42-48,
`4:58-63, 5:51-6:14; EX1003, ¶¶ 21-25, 45; EX1040, ¶¶ 47-48, 63-71.
`
`• “alarm delays” referenced once as
`“other alarm features” that are not
`parameter-specific:
`
`EX1001, 6:38-40; EX1003, ¶24.
`
`Paper 1 (RE244), pp. 8-14; Paper 1 (RE353), pp. 8-14; Paper 1 (RE249), pp. 8-15; Paper 28 (RE244), pp. 1-4; Paper 27 (RE353), pp. 1-5; Paper 26 (RE249), pp. 1-5.
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`Claim Construction
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of time”
`(RE353) / “alarm hold period of time” (RE249)
`
`• The Examiner issued a rejection of the RE244, RE249 and RE353 patent claims based
`on an interpretation requiring post-alarm suspensions, consistent with the original
`‘121 patent claims.
`
`Paper 1 (RE244), pp. 11-12; Paper 1 (RE353), pp. 12-13; Paper 1 (RE249), pp. 12-13.
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`EX1021 (RE244), p. 19;
`EX1021 (RE353), p. 18;
`EX1021 (RE249), pp. 17-18.
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`
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`Claim Construction
`
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• The stated purpose of the RE244, RE353,
`and RE249 patents would be rendered
`nonsensical if construed to cover pre-alarm
`delays.
`
`EX1001, 2:38-42
`
`EX1001, 2:45-60
`
`Paper 28 (RE244), pp. 1, 4; Paper 27 (RE353), pp. 1, 4-5; Paper 26 (RE249), pp. 1, 5; EX1040, ¶¶47-49, 72.
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`Claim Construction
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`• “alarm activation threshold” (RE244/RE353) relates to interpretation of “alarm delay
`or suspension period of time” (RE244) / “alarm suspension period of time” (RE353).
`
`RE244 Patent, Limitation 1(f):
`
`RE353 Patent, Limitation 1(e):
`
`EX1001 (RE244); see also limitations 13(e) and 18(h)
`
`EX1001 (RE353); see also limitations 13(d) and 18(g)
`• If the alarm activation of the alarm is not required, claims would mean the same
`thing if they recited “alarm activation threshold.” (EX1040, ¶70)
`
`Paper 28 (RE244), p. 3; Paper 27 (RE353), p. 4.
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`Claim Construction
`• “activation threshold”/ “alarm condition”
`(RE249) relate to interpretation of “alarm hold
`period of time” (RE249).
`
`RE249 patent, limitation 1(e)
`
`• Only “alarm condition” appears in the
`specification and is only described as a
`condition that has triggered an alarm.
`
`EX1001 (RE249); see also id. limitations 13(d) and 18(f).
`
`EX1001 (RE249), 4:49-55; see also 2:33-38
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`Paper 26 (RE249), p.4; EX1040, ¶¶71-72.
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`Claim Construction
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`• “Instrument manager 260” is the only part of the system described as controlling alarm suspensions
`(EX1040, ¶ 71):
`Fig. 3
`
`EX1001, 5:38-41.
`
`• The specification does not disclose any embodiment
`wherein an out-of-limit parameter does not
`automatically generate an alarm, or how a processor
`would determine to not activate an alarm and
`proceed immediately to an alarm suspension when a
`parameter is out-of-limits.
`
`EX1001, 5:51-54.
`
`Fig. 4
`
`EX1001, 6:4-7.
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`Paper 28 (RE244), p. 2-4; Paper 27 (RE353), p. 2-4; Paper 26 (RE249), p. 2-4; EX1040. 64-68, 70-71.
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`Claim Construction
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`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
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`• Masimo’s expert, Mr. Goldberg, agrees with Sotera’s expert that pre-alarm delays
`and post-alarm suspensions are distinct concepts (EX1003, ¶¶ 35-39; EX1042, 115:10-
`16) …
`
`EX1042, 115:10-16.
`… but was unable to identify where the specification teaches an alarm delay occurring
`before the alarm is activated (EX1042, 107:1-123:4).
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`Paper 28 (RE244), pp. 2, 4; Paper 27 (RE353), pp. 2, 5; Paper 26 (RE249), pp. 2, 5.
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`Claim Construction
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`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• Mr. Goldberg testified that the specification teaches classifying parameters
`in relation to the treatment time to get an out-of-limit parameter to a
`within-limit measurement:
`
`EX1042, 101:10-13.
`
`Paper 28 (RE244), p. 1; Paper 27 (RE353), p. 1; Paper 26 (RE249), p.1.
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`Claim Construction
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`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• Alarm delay, suspension, or hold periods of time do not have to be
`“predetermined.”
` Board was correct in its Institution Decision that the claims do not require
`“predetermined” time periods.
`•
`Paper 13 (RE244), pp. 25-26; Paper 12 (RE353), pp. 25-25; Paper 11 (RE249), pp. 11-13.
` Neither the specification nor claims limit the claimed “periods of time” to predetermined
`periods of time.
` The RE244, RE353, and RE249 do not identify any advantages of predetermined alarm
`delays or any disadvantages of other types of alarm delays (e.g., algorithmic).
`
`Paper 28 (RE244), pp. 5-8; Paper 27 (RE353), pp. 5-9; Paper 26 (RE249), pp. 6-9.
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`Claim Construction
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`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
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`• The claims do not limit the claimed “periods of time” to “predetermined”
`periods of time.
` The word “predetermined” does not appear in any claim.
` A PHOSITA would understand “period of time” to mean a time interval, whether
`predetermined or not. (EX1040, ¶ 58; EX1043, 363:22-365:2; 365:16-19; 376:15-22)
`
`EX1045, pp. 5
`
`EX1044, pp. 5-6
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`Paper 28 (RE244), pp. 5-8; Paper 27 (RE353), pp. 5-9; Paper 26 (RE249), pp. 6-9.
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`Claim Construction
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of time”
`(RE353) / “alarm hold period of time” (RE249)
`
`• Other claim language does not require importation of “predetermined” into
`“period of time”
`
`Limitation 1(g): initiate a parameter-specific alarm delay or suspension
`period of time corresponding to the physiological parameter …
`
`RE244
`
`• An unknown “period of time” may
`be “initiated.”
`•
`EX1040, ¶87; EX1044, ¶¶88-89 p. 4; EX1045, p. 4; EX1043,
`363:22-365:2; 365:16-19; 384:9-18.
`• An unknown “period of time” may
`“expire” or “pass.”
`•
`EX1040 (RE244, RE353), ¶87; EX1040, ¶90; EX1044, p. 3;
`EX1045, p. 3.
`
`RE353
`
`RE249
`
`Limitation 1(h): activate an alarm for the physiological parameter in
`response to expiration of an amount of delay or suspension associated
`with the parameter-specific alarm delay or suspension period of time.
`Limitation 1(f): determine that an alarm suspension should be initiated for a
`parameter-specific alarm suspension period of time corresponding to the
`physiological parameter …
`
`Limitation 1(h): activate the alarm when the measurement of the
`physiological parameter satisfies the alarm activation threshold after the
`parameter-specific alarm suspension period of time has passed.
`Limitation 1(f): access an alarm hold initiator for a parameter-specific
`alarm hold period of time corresponding to the physiological parameter …
`
`Limitation 1(i): subsequent to the parameter-specific alarm hold period of
`time passing, activate the indication of the alarm while the measurement of
`the physiological parameter satisfies the activation threshold.
`
`Paper 28 (RE244), pp. 11-12; Paper 27 (RE353), pp. 12-14; Paper 26 (RE249), pp. 12-14.
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`Claim Construction
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of time”
`(RE353) / “alarm hold period of time” (RE249)
`
`• Other claim language does not require importation of “predetermined”
`into “period of time”
`• Dependent claims requiring a “selected”
`period of time do not mean the periods of
`time must be predetermined.
`•
`EX1003, ¶88; EX1040 (RE244, RE353), ¶¶59, 88-89; EX1040
`(RE249), ¶¶59, 91-93; EX2018, 506:22-507:13.
`
`RE244
`
`RE353
`
`Limitation 1(g): [receive, from a user, an indication of] initiate a parameter-
`specific alarm delay or suspension period of time
`corresponding to the physiological parameter, the parameter-specific alarm
`delay or suspension period of time being [selected from] one of a plurality of
`parameter-specific alarm delay or suspension periods of time …
`Limitation 1(f): [receive, from a user,] determine that an [indication of] 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 [selected from]
`one of at least a plurality of parameter-specific alarm suspension periods of
`time …
`Limitation 1(f): [receive, from a user, an indication of] access an alarm hold
`initiator for a parameter-specific alarm [suspension] hold period of time
`corresponding to the physiological parameter, the parameter-specific alarm
`[suspension] hold period of time being [selected from] one of a plurality of
`parameter-specific alarm [suspension] hold periods of time …
`
`•
`
`If a “selected” period of time implies a
`predetermined time period, independent
`claims not so limited.
`•
`EX1040, ¶59; EX1001 (RE244, RE353, RE249), claims 1, 13,
`18.
`
`RE249
`
`Paper 28 (RE244), pp. 7, 12-13; Paper 27 (RE353), pp. 8, 14; Paper 26 (RE249), pp. 8, 14.
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`Claim Construction
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of time”
`(RE353) / “alarm hold period of time” (RE249)
`
`Sister Reissue Application No. 16/274,052
`
`
`
`• Masimo knows how to claim
`“predetermined” periods of time.
`EX2020, pp. 38-39; EX1040, ¶61.
`• Because both predetermined and
`algorithmic-based alarm delays
`were known in the art, a PHOSITA
`would understand that, in the
`absence of any disavowal, the
`claims cover both types of delays.
`EX1005; EX1007; EX1040, ¶¶53-54.
`
`
`
`Paper 1 (RE244), pp. 15-17, 19-20; Paper 1 (RE353), pp. 16-17, 19-20; Paper 1 (RE249), pp. 16-17, 19-20; Paper 28 (RE244), p. 5; Paper 27 (RE353), p. 6; Paper 26 (RE249), pp. 6-7.
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`Claim Construction
`
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• The specification does not limit the claimed “periods of time” to “predetermined”
`periods of time.
`
`EX1001, 3:3-6.
`• A PHOSITA would understand a “timer” may “track” a known or unknown “duration”
`of time. EX1040, ¶¶51-52.
`
`Paper 28 (RE244), p. 5; Paper 27 (RE353), p. 6; Paper 26 (RE249), pp. 6-7.
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`Claim Construction
`
`“alarm delay or suspension period of time” (RE244) / “alarm suspension period of
`time” (RE353) / “alarm hold period of time” (RE249)
`
`• The RE244, RE353, and RE249 do not criticize or purport to solve any problems relating to alarm delays
`that are not predetermined or are otherwise of unknown duration. (EX1040 ¶¶ 54-55)
`• The problem the challenged patents purport to solve is only with regard to a single suspension
`duration for all physiological parameters. (EX1040 ¶¶ 54-55)
`
`EX1001, 2:55-60
`• Masimo’s criticism of alarm delays or suspensions of unknown duration also applies to a construction
`requiring predetermined delays or suspensions. (EX1040 (RE244, RE353), ¶¶ 81-83; EX1040 (RE249), ¶¶82-83 ).
`
`Paper 28 (RE244), pp. 6-7; Paper 27 (RE353), pp. 7-8; Paper 26 (RE249), pp.7-8.
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`Background of Patient
`Monitoring
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`© 2021 Husch Blackwell LLP
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`State of the Art of Patient Monitoring
`
`• Parameter-specific pre-alarm
`delays have been known in
`the art since at least 1968, as
`disclosed in Halpern.
`
`
`
`EX1025 (RE244, RE353, RE249), 5:13-63; see also
`EX1026 (RE244, RE353, RE249), 4:14-29; EX1027
`(RE244, RE353, RE249), 33:42-50; EX1003, ¶37-38.
`
`Paper 1 (RE244), p. 15; Paper 1 (RE353), p. 15; Paper 1 (RE249), p.15.
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`EX1025 (RE244,
`RE353, RE249),
`5:43-63.
`
`
`
`State of the Art of Patient Monitoring
`
`• Post-alarm suspensions were
`well-known in the art before
`the priority date of the RE244,
`RE353, and RE249 patents.
`
`
`
`EX1028 (RE244, RE353, RE249), 2:6-12, 32-37; EX1029
`(RE244, RE353, RE249), 4:14-29; EX1030 (RE244, RE353,
`RE249), 33:42-50; EX1031 (RE244, RE353, RE249), 13:1-
`6, 42-47; EX1003, ¶37-39.
`
`EX1028 (RE244, RE353, RE249), 2:32-37.
`
`Paper 1 (RE244), p. 15; Paper 1 (RE353), p. 15; Paper 1 (RE249), p.15.
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`State of the Art of Patient Monitoring
`
`• Multi-parameter patient monitoring systems were well-known in the art before the
`priority date of the RE244, RE353, and RE249 patents.
` The challenged patents recognize multi-parameter monitoring systems were well-
`known in the prior art. (EX1001 (RE244, RE353, RE249), 1:36-51)
` Prior art owned by Masimo (2002) describes and claims multi-parameter monitoring
`devices. (EX1047, (63), claims 1, 19, 7:6-11)
` All three experts agree multi-parameter patient monitoring was well-known in the art.
`(EX1042, 59:4-14; EX2018, 366:9-367:2; 369:10-371:2; 382:14-386:22; EX1040 (RE244), ¶103; EX1040 (RE353), ¶101; EX1040 (RE249), ¶105)
`
`Paper 1 (RE244), pp. 15-17, 19-21; Paper 1 (RE353), pp. 15-17, 19-21; Paper 1 (RE249), pp. 15-17, 19-21; Paper 28 (RE244), pp. 23, 25; Paper 27 (RE353), pp. 22-23, 25-26; Paper 26 (RE249),
`pp. 22-23, 25-26.
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`Asserted Prior Art
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`Pre-Alarm Delay Prior Art
`Batchelder
`Baker-1
`
`Baker-2
`
`EX1005, Fig. 3
`
`EX1006, Figs. 5-6
`
`EX1007, Fig. 8
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`Post-Alarm Suspension Prior Art
`Saidara
`Malangi
`
`EX1008, Fig. 4D
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`EX1010, p. 7 (filing p. 21)
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`Grounds of Unpatentability
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`Grounds of Unpatentability
`
`• Grounds 1-4 are directed to a construction requiring pre-alarm
`delays.
`
`• Grounds 5-6 are directed to a construction requiring post-alarm
`suspensions.
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`Ground 1: Obviousness
`in View of Baker-1
`
`RE244: Claims 1, 6-8, 13, 14, 18, 19, and 23-26
`RE353: Claims 1, 6-8, 13, 14, 18, 19, and 23-25
`RE249: Claims 1, 6-8, 13, 14, 18, 19, 23, and 24
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`© 2021 Husch Blackwell LLP
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`U.S. Patent No. 5,865,736 (1997) - Baker-1
`
`EX1005
`
`Paper 1 (RE244), pp. 15-16; Paper 1 (RE353), p. 15; Paper 1 (RE249), p. 16
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`Baker-1
`
`• Baker-1 is directed to the reduction of false or nuisance alarms in patient
`monitoring, and in particular, pulse oximetry. (EX1005, 1:27-39)
`
`• Baker-1 explains that inhibiting alarms
`based on a “combination of the amount of
`time and the amount by which a threshold
`is past [sic]” solves the problem of pre-
`alarm delays of a “fixed” duration that do
`not account for the severity of the
`parameter measurement.
`
`Paper 1 (RE244), pp. 15-16; Paper 1 (RE353), p. 16; Paper 1 (RE249), p. 16; Paper 28 (RE244), pp. 9-10; Paper 27 (RE353), pp. 9-10; Paper 26 (RE249), pp. 9-11.
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`EX1005, 1:40-50.
`
`EX1005, Fig. 1
`
`
`
`Baker-1
`• Baker-1 discloses embodiments that utilize algorithms to calculate different alarm delays for
`SpO2 and pulse rate based on the amount of time and amount by which a SpO2 or pulse rate
`measurement crosses a SpO2 or pulse rate threshold.
`
`• An alarm is generated when the
`integral value 86 (Isat(n) and Irate (n))
`exceeds the integral threshold 74:
`
`EX1005, Fig. 3.
`
`Paper 1 (RE244), pp. 34-38; Paper 1 (RE353), pp. 34-38; Paper 1 (RE249), pp 34-38; EX1005, 3:18-31, 5:29-38.
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`Baker-1
`• Different alarm delay durations result from a patient’s SpO2 and pulse rate measurements, the
`SpO2 or pulse rate thresholds (“Tsat” and “Trate”), and the saturation and pulse rate integral
`thresholds 74.
`
`•
`
`•
`
`Shorter delays result from more
`severe parameter measurements
`
`Shorter delays result from lowering
`the SpO2 or pulse rate thresholds and
`integral thresholds.
`
`• No alarm will activate of the
`parameter measurement returns
`within limits before the integral
`threshold is reached.
`
`Paper 1 (RE244), pp. 34-38; Paper 1 (RE353), pp. 34-38; Paper 1 (RE249), pp 34-38; EX1005, 3:18-55; 5:29-38.
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`EX1003 (RE244), ¶¶ 79-84, EX. A, pp. 1-2;
`EX1003 (RE353), ¶¶ 80-85, EX. A, pp. 1-2;
`EX1003 (RE249), ¶¶ 78-83, EX. A, pp. 1-2.
`
`
`
`Obviousness in view of Baker -1
`Independent Claim 1
`
`• Masimo’s arguments are premised on importing “predetermined” into “period of time.”
`• Disputed claim limitations of independent claim 1 for the RE244, RE353, and RE249 patents:
`
`RE244
`Limitation 1(g): initiate a parameter-specific alarm delay or suspension period
`of time corresponding to the physiological parameter, the parameter-specific
`alarm delay or suspension period of time being one of a plurality of parameter-
`specific alarm delay or suspension periods of time, the parameter-specific alarm
`delay or suspension period of time being different from at least one other
`parameter-specific alarm delay or suspension period of time corresponding to at
`least one other physiological parameter for which the one or more processors are
`configured to determine at least one measurement; and
`
`RE353
`Limitation 1(f): 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;
`
`RE249
`Limitation 1(f): access an alarm hold initiator for a parameter-specific alarm
`hold period of time corresponding to the physiological parameter, the parameter-
`specific alarm hold period of time being one of a plurality of parameter-specific
`alarm hold periods of time, the parameter-specific alarm hold