`
`By:
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`Joseph R. Re (Reg. No. 31,291)
`Jarom D. Kesler (Reg. No. 57,046)
`Joshua J. Stowell (Reg. No. 64,096)
`Stephen W. Larson (Reg. No. 69,133)
`Jacob L. Peterson (Reg. No. 65,096)
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail: AppleIPR2020-1523-703@knobbe.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2020-01523
`U.S. Patent 8,457,703
`
`
`
`
`
`
`PATENT OWNER RESPONSE
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. MASIMO’S PIONEERING TECHNOLOGY ................................................ 5
`
`A.
`
`B.
`
`C.
`
`The ’703 Patent ..................................................................................... 5
`
`Introduction To The Independent Claims ........................................... 12
`
`Prosecution Of The ’703 Patent .......................................................... 14
`
`III.
`
`PETITIONER’S REFERENCES .................................................................. 15
`
`IV. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 16
`
`V.
`
`LEGAL STANDARDS ................................................................................. 17
`
`VI. CLAIM CONSTRUCTION .......................................................................... 19
`
`A.
`
`B.
`
`“Reducing/Reduce Activation Of An Attached Sensor” .................... 19
`
`“Processing Characteristics” ............................................................... 21
`
`1.
`
`2.
`
`Petitioner Failed To Construe “Processing
`Characteristics” ......................................................................... 21
`
`Construction Of “Processing Characteristics” .......................... 23
`
`VII. GROUND 1A FAILS TO DEMONSTRATE OBVIOUSNESS .................. 27
`
`A. Overview Of Diab ............................................................................... 27
`
`B.
`
`C.
`
`Overview Of Amano ........................................................................... 28
`
`Petitioner Fails to Show That A POSITA Would Have
`Modified Diab To Operate At Lower And Higher Power
`Consumption Levels Based On Amano .............................................. 29
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`3.
`
`4.
`
`Overview Of The Deficiencies In Petitioner’s
`Argument .................................................................................. 30
`
`A POSITA Would Not “Suspend And Not
`Execute” Diab’s Motion Artifact Suppression
`Module ...................................................................................... 33
`
`A POSITA Would Not Have Been Motivated To
`Combine Diab And Amano ...................................................... 41
`
`Petitioner Fails To Show That Suspension Of
`Diab’s Motion Artifact Suppression Module
`Would Result In Lower Power Consumption
`Levels ........................................................................................ 45
`
`D. Diab And Amano Do Not Disclose Or Suggest
`Comparing “Processing Characteristics To A
`Predetermined Threshold” ................................................................... 48
`
`E.
`
`Diab And Amano Do Not Disclose Or Suggest Reducing
`An Amount Of Processing By A Signal Processor ............................. 52
`
`VIII. GROUND 1B FAILS TO DEMONSTRATE OBVIOUSNESS .................. 55
`
`IX. GROUND 1C FAILS TO DEMONSTRATE OBVIOUSNESS .................. 56
`
`A. Ground 1C Fails For The Same Reasons As Ground 1A ................... 57
`
`B.
`
`C.
`
`Overview Of Turcott ........................................................................... 57
`
`Petitioner Fails To Show That Turcott Discloses Or
`Suggests “Reducing/Reduce Activation Of An Attached
`Sensor” In Combination With The Other Claim
`Limitations ........................................................................................... 60
`
`-ii-
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`D. A POSITA Would Not Have Been Motivated To
`Combine Diab, Amano, And Turcott To Arrive At The
`Claimed Inventions.............................................................................. 61
`
`X. GROUNDS 2A-2C FAIL TO DEMONSTRATE
`OBVIOUSNESS ............................................................................................ 67
`
`XI. GROUNDS 3A-3B FAIL TO SHOW OBVIOUSNESS .............................. 69
`
`A.
`
`Petitioner Fails To Show That Amano Discloses
`Determining Measurement Values For One Or More
`Physiological Parameters .................................................................... 69
`
`1.
`
`2.
`
`Petitioner Fails To Address All Elements In
`Limitation 9[c] .......................................................................... 70
`
`Amano Does Not Determine Measurement Values .................. 71
`
`Petitioner Admits That Amano Does Not Compare
`“Processing Characteristics” To A Predetermined
`Threshold ............................................................................................. 73
`
`Petitioner Fails To Show That Turcott Discloses Or
`Suggests “Reducing/Reduce Activation Of An Attached
`Sensor” In Combination With The Other Claim
`Limitations ........................................................................................... 75
`
`B.
`
`C.
`
`XII. CONCLUSION .............................................................................................. 79
`
`
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Eon Corp. IP Holdings v. Silver Spring Networks, Inc.,
`815 F.3d 1314 (Fed. Cir. 2016) .......................................................................... 20
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 18
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ........................................................ 17, 18, 51, 71
`In re Kotzab,
`217 F.3d 1365 (Fed. Cir. 2000) .......................................................................... 18
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 18
`In re Magnum Oil Tools, Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .................................................................... 17, 18
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) .......................................................................... 19
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 18
`OrthoPediatrics Corp. v. K2M, Inc.,
`Case IPR2018-01548, Paper 9 (March 1, 2019) ........................................... 21, 23
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 24
`Schering Corp. v. Geneva Pharms., Inc.,
`339 F.3d 1373 (Fed. Cir. 2003) .......................................................................... 51
`Star Sci., Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .......................................................................... 18
`
`-iv-
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`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`OTHER AUTHORITIES
`37 C.F.R. § 42.65 ............................................................................................... 18, 51
`37 C.F.R. § 42.100 ................................................................................................... 24
`
`
`-v-
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`
`
`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`
`
`Expert Declaration of Vijay K. Madisetti Ph.D.
`
`Curriculum Vitae of Vijay K. Madisetti Ph.D.
`
`Excerpts from the deposition transcript of Brian Anthony, Ph.D.
`
`U.S. Patent No. 5,827,969 to Lee et al.
`
`U.S. Patent No. 6,402,690 to Rhee et al.
`
`Exhibit List, Page 1
`
`
`
`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`I.
`INTRODUCTION
`Masimo’s U.S. Patent No. 8,457,703 (“’703 patent”) discloses and claims
`
`innovative and nonobvious approaches to managing the power consumption of a
`
`low-power patient monitor. Masimo’s
`
`innovative monitor controls power
`
`consumption by intermittently changing the number of input samples received and
`
`processed by the monitor’s processor while continuously maintaining monitoring
`
`capability. By intermittently reducing the number of input samples received and
`
`processed based on characteristics of the optically detected signal, Masimo’s
`
`claimed monitor can reduce power consumption. The ’703 patent discloses several
`
`methods of determining when and how to change the number of input samples.
`
`One method intermittently changes activation of an attached sensor by, for
`
`example, changing the duty cycle of current supplied to the sensor LEDs. These
`
`changes can be triggered by the quality of the optical signal or physiological
`
`measurements determined from the optical signal. Driving the LEDs at a lower
`
`duty cycle consumes less power than driving the LEDs at a higher duty cycle.
`
`Importantly, the ’703 patent’s monitor intermittently changes the number of input
`
`samples during operation so that a clinician can continuously receive current
`
`patient information despite changes in monitor power consumption.
`
`Petitioner identifies eight grounds in the Petition based on four prior art
`
`references: Diab (Ex. 1007), Amano (Ex. 1004), Turcott (Ex. 1006), and Edgar
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`-1-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`(Ex. 1005). Every claim in the ’703 patent requires operating a patient monitor at
`
`“a lower power consumption level” and “a higher power consumption level.” In
`
`Grounds 1A-1C and 2A-2C, Petitioner argues that Diab, in combination with
`
`Amano or the “general knowledge” of a person of ordinary skill in the art
`
`(“POSITA”),
`
`renders
`
`these power-consumption-level
`
`limitations obvious.
`
`Petitioner concedes that Diab does not disclose operating its patient monitor at
`
`lower and higher power consumption levels. Therefore, Petitioner argues that
`
`Amano or the “general knowledge of a POSITA” would have motivated a POSITA
`
`to modify Diab by suspending and not executing Diab’s motion artifact
`
`suppression module 580 [blue] when motion is not detected.
`
`However, Diab’s oximeter relies on the motion artifact suppression module
`
`to generate two outputs: the heart rate and clean plethysmograph waveform
`
`
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`-2-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`(highlighted yellow above). Petitioner focuses exclusively, and incorrectly, on the
`
`heart rate determination in arguing that a POSITA would have been motivated to
`
`“suspend and not execute” Diab’s motion artifact suppression module. Petitioner
`
`ignores the generation of the clean plethysmograph waveform, which requires
`
`continuous operation of the motion artifact suppression module even when there is
`
`no motion. A POSITA would not have been motivated to “suspend and not
`
`execute” the module because doing so would have eliminated the critical clean
`
`plethysmograph waveform and compromised the utility of the oximeter.
`
`Diab also discloses that its processing actually speeds up (i.e., processes
`
`more data and thus uses more power) when there is no motion. This additional
`
`processing and power consumption when there is no motion directly contradicts
`
`Petitioner’s arguments. For at least these reasons, Grounds 1A-1C and 2A-2C do
`
`not render the challenged claims unpatentable.
`
`In Grounds 3A-3B, Petitioner argues that Amano, alone or in combination
`
`with Turcott, renders the challenged claims unpatentable. However, Petitioner fails
`
`to show how Amano or Turcott satisfy each claim limitation. Every challenged
`
`claim requires the patient monitor to continuously operate at a lower power
`
`consumption
`
`level
`
`to “determine measurement values for one or more
`
`physiological parameters of a patient.” Yet, in Grounds 3A-3B, Petitioner never
`
`-3-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`addresses whether Amano and Turcott disclose the “measurement values for one or
`
`more physiological parameters” required by the claims.
`
`Moreover, the embodiments of Amano relied on by Petitioner in Grounds
`
`3A-3B do not “determine measurement values for one or more physiological
`
`parameters of a patient.” Amano describes “a pulse wave examination apparatus”
`
`that qualitatively characterizes a patient’s pulse condition based on “classifications
`
`of Chinese medicine.” Specifically, Amano’s apparatus determines only a general
`
`condition of the user (“Ping mai,” “Hua mai,” and “Xuan mai”). Petitioner fails to
`
`show that Amano’s apparatus determines any measurement values for one or more
`
`physiological parameters. Thus, Petitioner has not shown Amano discloses all of
`
`the claim limitations.
`
`Every challenged claim also requires the patient monitor to compare
`
`“processing characteristics to a predetermined threshold.” The ’703 patent requires
`
`that the “processing characteristics” be determined from a signal received from the
`
`sensor’s optical detector. Amano does not disclose this limitation. Unlike the
`
`inventions in the ’703 patent, Amano determines the processing characteristics
`
`from a signal received from a separate acceleration sensor. Amano does not
`
`determine the processing characteristics from a signal received from an optical
`
`detector. For at least these reasons, Grounds 3A-3B do not render the challenged
`
`claims unpatentable.
`
`-4-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`Petitioner has failed to demonstrate that the asserted references render the
`
`challenged claims unpatentable. Masimo, therefore, respectfully requests that the
`
`Board affirm the patentability of the challenged claims.
`
`II. MASIMO’S PIONEERING TECHNOLOGY
`Masimo is a global medical device technology company that develops and
`
`manufactures innovative patient monitoring technologies, medical devices, and a
`
`wide array of sensors. Masimo was founded in 1989 as a garage start-up and went
`
`on to revolutionize non-invasive patient monitoring by solving long-standing and
`
`difficult problems facing the industry. Today, Masimo is a publicly traded
`
`company that employs over 6,300 people worldwide, with annual revenues of over
`
`$1.1 billion. A host of manufacturers use Masimo’s technology, including Philips,
`
`Atom, Mindray North America, GE Medical, Spacelabs, and Zoll.
`
`A. The ’703 Patent
`Masimo’s ’703 patent describes novel approaches for reducing the power
`
`consumption of patient monitors, such as pulse oximeters. Pulse oximeters are
`
`devices that are widely used for monitoring the oxygen saturation level of a
`
`patient’s arterial blood. (Ex. 1001, 1:18-35.) Conventional pulse oximeters include
`
`a sensor that has red and infrared LEDs and a photodiode detector. (Id.) In
`
`operation, the LEDs project light into the patient’s tissue. (Id.) The photodiode
`
`detects the emitted light as it emerges from the tissue. (Id.) A signal processor, in
`
`-5-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`communication with the sensor, calculates physiological measurements, including
`
`oxygen saturation and pulse rate, based on the detected light. (Id. at 1:38-47.) A
`
`monitor then displays the calculated measurements to the clinician. (Id.)
`
`The ’703 patent discloses that patient monitors, such as pulse oximeters, are
`
`increasingly utilized in portable, battery-operated applications. (Id., 1:55-56.) For
`
`example, a patient may require a portable pulse oximeter during emergency
`
`transport between hospital wards. (Id., 1:56-59.) Pulse oximeters are also
`
`increasingly implemented as “plug-in modules for multiparameter patient monitors
`
`having a restricted power budget.” (Id., 1:59-61.) The expanded use of pulse
`
`oximeters created “an increasing demand for lower power and higher performance
`
`pulse oximeters.” (Id., 1:61-63.)
`
`The ’703 patent explains that POSITAs attempted to meet the long-felt need
`
`for lower power patient monitors by developing monitors having a “sleep mode.”
`
`(Id., 1:63-2:16.) In sleep mode, the monitor’s processor powers down, except
`
`perhaps for a portion of memory. (Id.) The monitor enters the sleep mode if it does
`
`not detect a significant change in a particular physiological measurement for a
`
`predetermined period of time. (Id.) A monitor operating in sleep mode periodically
`
`checks the physiological measurements of the patient based on an internal timer to
`
`determine whether to wake up (i.e., power up the monitor’s processor). (Id.)
`
`-6-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`While monitors utilizing a sleep mode reduce power consumption, the ’703
`
`patent identifies a number of disadvantages of using sleep-mode techniques during
`
`patient monitoring, particularly in the case of pulse oximetry. (Id., 2:17-28.) When
`
`functioning in the sleep mode, the monitor is inactive and may miss critical patient
`
`events, such as oxygen desaturation. (Id.) The ’703 patent explains that earlier
`
`efforts to account for this disadvantage failed. The patent explains, “[T]here is a
`
`trade-off between shorter but more frequent sleep periods to avoid a missed event
`
`and the increased processing overhead to power-up after each sleep period.” (Id.)
`
`Conventional monitors operating in sleep mode had other disadvantages. For
`
`example, the monitors would not reflect the time of the last active measurement,
`
`which obfuscated the current state of the patient. (Id.) Additionally, the sleep-mode
`
`oximeters use only output parameters, such as oxygen saturation, to determine
`
`whether to operate in active or sleep mode. (Id.) The oximeters do not use internal
`
`parameters, such as signal quality, to set the operation status. (Id.) The failure to
`
`account for internal parameters resulted in inaccurate or unclear outputs. (Id.) For
`
`all of these reasons, sleep-mode monitors did not address the long-felt need for
`
`patient monitors that use lower power, but remain in active mode, rather than sleep
`
`mode.
`
`The inventions described in the ’703 patent do not suffer from the
`
`disadvantages of sleep-mode monitors. The inventive patient monitors modify
`
`-7-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`power consumption by effectively increasing or decreasing the number of input
`
`samples received and processed by the monitor. (Id., 6:9-24.) “Sampling, including
`
`acquiring input signal samples and subsequent sample processing, can be reduced
`
`during high signal quality periods and increased during low signal quality periods
`
`or when critical measurements are necessary.” (Id., 6:11-15.) By adjusting the
`
`samples received and processed, the monitor can “regulates power consumption to
`
`satisfy a predetermined power target, to minimize power consumption, or to simply
`
`reduce power consumption.” (Id., 6:16-18.)
`
`The monitor determines whether to increase or decrease sample processing
`
`by evaluating physiological measurements and/or signal statistics. (Id., 6:28-44;
`
`see also id., 5:11-27 (describing system operation).) Physiological measurements
`
`include, but are not limited to, oxygen saturation, pulse rate, and plethysmograph.
`
`(Id., 5:13-16.) Signal statistics include, but are not limited to, signal strength, noise,
`
`and motion artifacts. (Id., 5:16-17.) Thus, the disclosed patient monitors
`
`advantageously control power consumption based on output parameters, such as
`
`physiological measurements, and/or internal parameters, such as signal statistics.
`
`(Id., 5:24-27.)
`
`In a preferred embodiment, a patient monitor increases or decreases the
`
`input samples by changing the duty cycle of the current supplied by the monitor’s
`
`drivers to the LEDs. (Id., 6:56-7:14.) In a conventional patient monitor, the duty
`
`-8-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`cycle used to drive the LEDs is constant during monitoring. (Id.) However, a
`
`constant duty cycle can result in significant power consumption because the LED
`
`drivers “require a significant portion of the overall pulse oximeter power budget.”
`
`(Id.) The ’703 patent discloses that “[i]ntermittently reducing the drive current duty
`
`cycle can advantageously reduce power dissipation without compromising signal
`
`integrity.” (Id..) Thus, in a preferred embodiment, the ’703 patent discloses
`
`intermittently reducing the duty cycle of the LED drivers from 25% to about
`
`3.125%. (Id., 7:4-8, Fig. 5.)
`
`In addition to changing the duty cycle, the ’703 patent discloses that the
`
`patient monitor may have a “data off” period where the LEDs are turned off for
`
`longer than one drive cycle. (Id., 7:8-12.) A “data off” state differs from sleep
`
`mode for several reasons, including that the processors are not powered down in
`
`the “data off” state. (See e.g., 2:1-16, 7:8-14 (describing sleep mode and data off).)
`
`The “data off” state may be used in addition to high and low duty cycles to manage
`
`the power consumption of the monitor. (Id., 8:4-46, Fig. 8.) Figure 81 below shows
`
`the power consumption of the monitor during the high duty cycle state [red], low
`
`duty cycle state [green], and data off state. (Id.)
`
`
`1 Color and labels have been added to figures unless otherwise noted.
`
`-9-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`
`
`
`(Id.)
`
`
`
`The ’703 patent discloses other methods to increase or decrease the samples
`
`received and processed. For example, the monitor can vary the number of data
`
`blocks processed by the processor. (Id., 6:2-8.) Figures 7A-B (below) “illustrate
`
`data blocks 700, which are processed by post processor 430.” (Id., 7:40-41, Figs.
`
`7A-B.) As shown in Figure 7A below, each data block has n samples 702 of the
`
`pre-processor output. (Id., 7:41-45.)
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`-10-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`
`
`
`Each data block has a relative time shift 706 from the preceding data block
`
`creating an overlap 708 between two adjacent data blocks 710, 720. (Id., 7:51-60.)
`
`“The greater the overlap 708, i.e. the smaller the time shift 706, the more data
`
`blocks there are to process in the post-processor 430 (FIG. 4), with a corresponding
`
`greater power consumption.” (Id., 7:55-58.) The ’703 patent discloses that the
`
`“overlap 708 between successive data blocks 710, 720 may vary from n-1 samples
`
`to no samples, i.e. no overlap.” (Id., 7:58-60.)
`
`Figure 7B (below) shows “there may be a sample gap 756 or negative
`
`overlap, i.e. samples between data blocks that are not processed by the post-
`
`processor, allowing further post-processor power savings.” (Id., 7:60-63.)
`
`-11-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`
`
`
`In operation, a patient event, such as poor oxygen saturation, may trigger the
`
`monitor to increase the samples received and processed, such as by moving from a
`
`low duty cycle or data off state to a high duty cycle. (Id., 8:47-61, Fig. 9.)
`
`Conversely, if the monitor is in a high duty cycle state and neither an event nor low
`
`signal quality occurs, the monitor may transition to a low duty cycle to conserve
`
`power. (Id., 9:1-13.) Thus, Masimo’s inventive patient monitor quickly adapts
`
`during adverse patient events or upon signal quality issues and, therefore, solves
`
`many of the long-felt and unmet problems associated with conventional monitors
`
`that operate in a sleep mode. (Ex. 2001, ¶30.)
`
`B.
`
`Introduction To The Independent Claims
`The ’703 patent has six independent claims. Claims 1, 9, and 12 describe
`
`methods of managing power consumption by (a) reducing activation of an attached
`
`sensor, (b) reducing an amount of processing by a signal processor, or (c) including
`
`an override condition, respectively. Claims 15, 20, and 22 describe patient
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`-12-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`monitors configured to manage power consumption using similar techniques as the
`
`method claims. Claim 1 is illustrative (but not representative) of some relevant
`
`features claimed in the ’703 patent. Petitioner adopted a numbering system for the
`
`claim limitations in the Petition. (See e.g., Pet., 40-43.) Masimo has adopted
`
`Petitioner’s numbering system in this Response for ease of reference. Claim 1
`
`recites:
`
`[1p] A method of managing power consumption during continuous patient
`
`monitoring by adjusting behavior of a patient monitor, the method comprising:
`
`[1a] driving one or more light sources configured to emit light into tissue of
`
`a monitored patient;
`
`[1b] receiving one or more signals from one or more detectors configured to
`
`detect said light after attenuation by said tissue;
`
`[1c] continuously operating a patient monitor at a lower power consumption
`
`level to determine measurement values for one or more physiological
`
`parameters of a patient;
`
`[1d] comparing processing characteristics to a predetermined threshold; and,
`
`[1e] when said processing characteristics pass said threshold, transitioning to
`
`continuously operating said patient monitor at a higher power
`
`consumption level,
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`-13-
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`IPR2020-01523
`Apple Inc. v. Masimo Corporation
`[1f] wherein said continuously operating at said lower power consumption
`
`level comprises reducing activation of an attached sensor,
`
`[1g] said sensor positioning said light sources and said detectors proximate
`
`said tissue.
`
`C.
`
`Prosecution Of The ’703 Patent
`During prosecution, the Examiner rejected the pending claims over Swedlow
`
`(Ex. 1009), a patent that described a conventional “sleep mode” pulse oximeter.
`
`(Ex. 1002, 65-68, 90-93; see e.g., Ex. 1009, 4:27-31 (“The present invention
`
`applies to a diagnostic device which enters a sleep mode while a patient is
`
`stable.”).) Masimo distinguished Swedlow by identifying the language in the
`
`pending claims requiring the continuous determination of measurement values, and
`
`the description in the specification distinguishing the inventions in the ’703 patent
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`from “sleep mode” pulse oximeters. (Id., 90-93.)
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`Masimo subsequently conducted an interview with the Examiner during
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`which two additional references were discussed: Lee (Ex. 2004) and Rhee (Ex.
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`2005). (Ex. 1002, 108.) The Examiner agreed with Masimo that Lee and Rhee did
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`“not specifically teach the reducing activation/duty cycle/on-off stages of the
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`energy source(s) during operating the sensor.” (Id., 117-118.) The Examiner also
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`found the “prior art does not teach or suggest ‘said continuously operating at said
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`lower power consumption level comprises reducing activation of an attached
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`sensor’, ‘said continuously operating at said lower power consumption level
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`comprises reducing an amount of processing by a signal processor’, or ‘said
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`processing characteristics pass said threshold, transitioning to continuously
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`operating said patient monitor at a higher power consumption level, wherein said
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`processing characteristics include an override condition’, in combination with the
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`other elements/steps.” (Id., 118.)
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`III. PETITIONER’S REFERENCES
`Petitioner’s unpatentability grounds rely on four references: Diab (Ex.
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`1007), Amano (Ex. 1004), Turcott (Ex. 1006), and Edgar (Ex. 1005). Petitioner
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`states, “None of these references were cited in any office action by the examiner
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`during prosecution.” (Pet. 4.) However, Petitioner does not disclose that the
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`Examiner considered Diab during prosecution:
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`(Ex. 1001, page 2.)
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`As discussed herein, all of Petitioner’s references operate differently than the
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`claimed methods and patient monitors and do not disclose or suggest the claimed
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`inventions.
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`IV. LEVEL OF ORDINARY SKILL IN THE ART
`Petitioner argues a POSITA “would have had a Bachelor of Science degree
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`in an academic discipline emphasizing the design of electrical, computer, or
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`software technologies, in combination with training or at least two years of related
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`work experience with capture and processing of data or information, including but
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`not limited to physiological monitoring technologies or a Master of Science degree
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`in a relevant academic discipline with less than a year of related work experience
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`in the same discipline.” (Pet. 5; Ex. 1003, ¶33.) Petitioner’s declarant adds that a
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`“POSITA would have been someone with a working knowledge of physiological
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`monitoring technologies.” (Ex. 1003, ¶33.)
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`Petitioner’s asserted level of skill is inconsistent with its declarant’s opinion
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`regarding the relevant field. Petitioner’s declarant states, “The ’703 patent and the
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`prior art references discussed herein are all from the field of non-invasive optical
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`biosensors.” (Ex. 1003, ¶16.) Petitioner’s declarant confirmed during cross-
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`examination that this statement accurately characterizes the relevant field. (Ex.
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`2003, 23:1-20.) Yet, as shown above and acknowledged by Petitioner’s declarant,
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`Petitioner’s definition of POSITA does not require any experience with non-
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`invasive optical biosensors and, thus, does not describe the level of skill in the art.
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`(Ex. 2003, 85:16-86:4, 96:8-13.)
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`However, even under a lower standard where a POSITA has a working
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`knowledge of physiological monitoring technologies, Petitioner has failed to show
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`that the asserted grounds render the challenged claims obvious. Thus, for this
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`proceeding, Masimo applies the asserted level of skill identified in the Petition.
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`(Ex. 2001, ¶22.)
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`V. LEGAL STANDARDS
`“In an IPR, the petitioner has the burden from the onset to show with
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`particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid
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`Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016). The Board is not “free to adopt
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`arguments on behalf of petitioners that could have been, but were not, raised by the
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`petitioner during an IPR.” In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364,
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`1381 (Fed. Cir. 2016). “The petitioner must instead articulate specific reasoning,
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`based on evidence of record,” as set out in its petition “to support the legal
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`conclusion of obviousness.” Id. at 1380. The Board “must base its decision on
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`arguments that were advanced by a party.” Id. at 1381. The Board cannot “decide
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`unpatentability theories never presented by the petitioner.” Id.
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`To prevail on any obviousness ground, a petitioner may not simply identify
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`individual claim components—it must show why a “skilled artisan, with no
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`knowledge of the claimed invention, would have selected these components for
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`combination in the manner claimed.” In re Kotzab, 217 F.3d 1365, 1371 (Fed. Cir.
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`2000). The petitioner must support even simple modifications to a reference with
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`some motivation to make the change. See In re Gordon, 733 F.2d 900, 902 (Fed.
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`Cir. 1984).
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`In addition, a petitioner cannot rely on “mere conclusory statements.”
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`Magnum Oil, 829 F.3d at 1380. Rather, the petitioner must set forth “some
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`articulated reasoning with some rational underpinning to support the legal
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`conclusion of obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19
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`(2007) (internal citation omitted). Similarly, a petitioner cannot simply rely on an
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`expert’s unsubstantiated and conclusory opinions. See 37 C.F.R. § 42.65 (“Expert
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`testimony that does not disclose the underlying facts or data on which the opinion
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`is based is entitled to little or no weight.”); Harmonic, 815 F.3d at 1363 (Affirming
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`that the petitioner failed to establish obviousness where expert testimony “add[ed]
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`nothing beyond the conclusory statements in [the] petition.”).
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`An appropriate obviousness inquiry cannot involve even a “hint of
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`hindsight.” Star Sci., Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1375 (Fed.
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`Cir. 2011). A petitioner may not “simply retrace[] the path of the inventor with
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`hindsight, discount[] the number and complexity of the alternatives, and conclude[]
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`that the invention . . . was obvious.” Ortho-McNeil Pharm., Inc. v. Mylan Labs.,
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`Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008). Likewise, “[c]are must be taken to
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`avoid hindsight reconstruction by using the patent in suit as a guide through the
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`maze of prior art referen