`
`Filed: May 19, 2023
`
`By:
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`Irfan A. Lateef (Reg. No. 51,922)
`Ted M. Cannon (Reg. No. 55,036)
`Jarom D. Kesler (Reg. No. 57,046)
`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:
`AppleIPR127-1@knobbe.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2022-01299
`U.S. Patent 7,761,127
`
`
`
`
`
`
`PATENT OWNER RESPONSE
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION AND TECHNOLOGICAL BACKGROUND .......... 1
`
`A.
`
`B.
`
`C.
`
`Pulse Oximetry ............................................................................... 1
`
`Temperature-Induced Wavelength Shift ........................................ 3
`
`The Claimed Invention ................................................................... 7
`
`II.
`
`LEVEL OF ORDINARY SKILL IN THE ART .................................... 17
`
`III. CLAIM CONSTRUCTION ................................................................... 17
`
`A.
`
`B.
`
`C.
`
`D.
`
`“thermal mass” (claims 1, 7, 13, 20, 26) ...................................... 17
`
`“bulk temperature for the emitters” (claims 1 and 26) “bulk
`temperature for the thermal mass” (claim 7) “bulk
`temperature of the light emitting sources” (claim 13) “bulk
`temperature for the light emitting sources” (claim 21) ................ 22
`
`Claim 7 interrelates the measured bulk temperature, LED
`operating wavelengths, and physiological parameters. ................ 26
`
`Claim 21 interrelates the measured bulk temperature and
`LED operating wavelengths. ........................................................ 30
`
`IV. ALL CLAIMS ARE PATENTABLE BECAUSE THE PRIOR
`ART DOES NOT DISCLOSE OR MAKE OBVIOUS A
`“THERMAL MASS” ............................................................................. 30
`
`A. Yamada’s substrate lacks a “thermal mass.” ................................ 31
`
`B.
`
`Chadwick’s metal core is not a “thermal mass.” ......................... 33
`
`1.
`
`Chadwick’s cooling function is different from
`resisting temperature change on a scale relevant to
`estimating LED wavelengths. ............................................ 35
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`2.
`
`3.
`
`4.
`
`Apple’s “bulk temperature” argument fails to show
`Chadwick has a “thermal mass.” ....................................... 37
`
`Apple conducted no structural analysis showing
`Chadwick discloses the required temperature-change
`resistance. ........................................................................... 38
`
`Apple conducted no testing, simulations, or
`assessment showing Chadwick discloses the required
`temperature-change resistance. .......................................... 41
`
`C. Apple does not propose any modification to Yamada’s
`substrate or Chadwick’s metal core that would make either
`a “thermal mass.” ......................................................................... 42
`
`V.
`
`CLAIMS 1-19, 21, 22, AND 25-30 ARE PATENTABLE
`BECAUSE THE PRIOR ART DOES NOT DISCLOSE OR
`MAKE OBVIOUS A “TEMPERATURE SENSOR” THAT
`MEASURES A “BULK TEMPERATURE” TO DETERMINE
`LED WAVELENGTHS ......................................................................... 44
`
`A. Yamada and Chadwick do not disclose or suggest the “bulk
`temperature” limitations of claims 7-12. ...................................... 45
`
`B. Yamada, Chadwick, and Cheung do not disclose or suggest
`the “bulk temperature” limitations of claims 13-19, 21, 22,
`and 25. .......................................................................................... 47
`
`C. Yamada, Chadwick, and Noguchi do not disclose or suggest
`the “bulk temperature” limitations of claims 1-12 and 26-
`30. ................................................................................................. 49
`
`VI. ALL CLAIMS ARE PATENTABLE BECAUSE APPLE DID
`NOT PROVE A MOTIVATION TO COMBINE ................................. 50
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`A.
`
`The prior art teaches away from the invention............................. 51
`
`B. A POSITA would not have been motivated to combine
`Yamada and Chadwick in a manner that yields the claimed
`invention. ...................................................................................... 57
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Adding Chadwick’s core to Yamada as a heat sink
`would not have motivated any combination yielding
`the invention. ...................................................................... 57
`
`Adding Chadwick’s core to Yamada to reduce
`wavelength shift would have discouraged a POSITA
`from using the core’s temperature to estimate LED
`wavelengths. ....................................................................... 58
`
`Adding Chadwick’s core to Yamada would not have
`allowed measurement of an average LED
`temperature nor motivated any combination yielding
`the invention. ...................................................................... 59
`
`Adding Chadwick’s core to Yamada to draw heat
`away from the LEDs would not have motivated any
`combination yielding the invention. .................................. 62
`
`Apple’s generic known-techniques argument is
`inadequate to show a motivation to combine. ................... 62
`
`A POSITA would not have reasonably expected
`success. ............................................................................... 63
`
`C. A POSITA would not have been motivated to combine
`Yamada, Chadwick, and Cheung in a manner that yields
`claims 13-25. ................................................................................ 63
`
`-iii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`D. A POSITA would not have been motivated to combine
`Yamada, Chadwick, and Noguchi in a manner that yields
`claims 1-12 or 26-30..................................................................... 64
`
`1.
`
`2.
`
`3.
`
`A desire to compensate for wavelength shift would
`not have motivated any combination yielding the
`invention. ............................................................................ 64
`
`A desire to improve accuracy would not have
`motivated any combination yielding the invention. .......... 66
`
`A POSITA would not reasonably have expected
`success. ............................................................................... 66
`
`VII. CLAIMS 4-5, 11-12, 18-19, 24-25, AND 28-29 WOULD NOT
`HAVE BEEN OBVIOUS OVER APPLE’S GROUNDS 1B, 1D,
`AND 1F ADDING LEIBOWITZ’S MULTI-LAYER CIRCUIT
`BOARD .................................................................................................. 67
`
`VIII. THE CHALLENGED CLAIMS WOULD NOT HAVE BEEN
`OBVIOUS OVER APPLE’S GROUNDS 2A-2F. ................................. 69
`
`IX. OBJECTIVE EVIDENCE SUPPORTS NON-OBVIOUSNESS .......... 70
`
`A. Masimo’s rainbow® sensors embody the invention. ................... 70
`
`B.
`
`C.
`
`D.
`
`The rainbow® sensors are commercially successful. .................. 77
`
`The rainbow® sensors have received significant industry
`praise. ............................................................................................ 78
`
`There is a nexus between the commercial success and
`industry praise and the invention. ................................................ 79
`
`X.
`
`CONCLUSION ....................................................................................... 79
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`ActiveVideo Networks v. Verizon Comms.,
`694 F.3d 1312 (Fed. Cir. 2012) ............................................................. 61, 62
`Adidas AG v. Nike, Inc.,
`963 F.3d 1355 (Fed. Cir. 2020) ................................................................... 62
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ................................................................... 69
`Ex parte Burns,
`No. Appeal 2016-000351, 2017 WL 2132361
`(PTAB Apr. 28, 2017) ................................................................................. 57
`Chef Am., Inc. v. Lamb-Weston, Inc.,
`358 F.3d 1371 (Fed. Cir. 2004) ................................................................... 28
`Chemours Co. FC, LLC v. Daikin Indus.,
`4 F.4th 1370 (Fed. Cir. 2021) ...................................................................... 77
`CommScope Techs. LLC v. Dali Wireless Inc.,
`10 F.4th 1289 (Fed. Cir. 2021) .............................................................. 28, 41
`Edwards Lifesciences LLC v. Cook Inc.,
`582 F.3d 1322 (Fed. Cir. 2009) ............................................................. 21, 25
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ..................................................................... 52
`Muniauction, Inc. v. Thomson Corp.,
`532 F.3d 1318 (Fed. Cir. 2008) ................................................................... 69
`New Hampshire v. Maine,
`532 U.S. 742 (2001) ............................................................................... 28, 41
`Nystrom v. TREX Co.,
`424 F.3d 1136 (Fed. Cir. 2005) ................................................................... 21
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`SAS Inst. v. Iancu,
`138 S. Ct. 1348 (2018) ........................................................................... 36, 37
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) ................................................................... 41
`Wellman, Inc. v. Eastman Chem. Co.,
`642 F.3d 1355 (Fed. Cir. 2011) ................................................................... 29
`OTHER AUTHORITIES
`35 U.S.C. § 312 ................................................................................................. 36
`
`
`
`-vi-
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`2001
`
`2002
`
`Declaration of Jeremiah S. Helm in Support of Pro Hac Vice
`Motion
`
`Declaration of Mohamed Diab (Withdrawn) (Confidential
`Version Expunged)
`
`2003-2004 Expunged
`
`2005
`
`“Rad-57 Signal Extraction Pulse CO-Oximeter Operator’s
`Manual,” Masimo, 2018
`
`2006-2007 Expunged
`
`2008
`
`Masimo Corp. et al. v. Apple Inc., June 6-10, 2022 Public
`Hearing Transcript, ITC Inv. No 337-TA-1276
`
`2009-2010 Expunged
`
`2011
`
`Masimo Corp. et al. v. Apple Inc., Masimo’s June 27, 2022 Public
`Initial Post-Hearing Brief, ITC Inv. No 337-TA-1276
`
`2012-2016 Expunged
`
`2017
`
`“Material Qualification Henkel 84-1LMISR4 Die Attach
`Adhesive,” Masimo
`
`2018-2021 Expunged
`
`2022
`
`2023
`
`2024
`
`2025
`
`September 22, 2019 Masimo “Awards” Webpage
`
`“Masimo Honored with FDNY ‘Flag of Heroes’,” EMS1, 2008
`
`Photograph of “Flag of Heroes”
`
`Photograph of Masimo CEO Joe Kiani with “Flag of Heroes”
`
`Exhibit List, Page 1
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2026
`
`U.S. Patent No. 5,758,644
`
`2027-2028 Expunged
`
`2029
`
`2030
`
`Masimo Rainbow Sensor Finger Assembly Photograph, Top Side
`(current rainbow®)
`
`Masimo Rainbow Sensor Finger Assembly Photograph, Bottom
`Side (current rainbow®)
`
`2031-2033 Expunged
`
`2034 – 2050 RESERVED
`
`2051
`
`Declaration of Jack Goldberg (Withdrawn) (Confidential Version
`Expunged)
`
`2052
`
`Curriculum Vitae of Jack Goldberg
`
`2053
`
`2054
`
`2055
`
`2056
`
`Design of Pulse Oximeters, J.G. Webster; Institution of Physics
`Publishing, 1997
`
`Field Guide to Illumination, A. Arecchi et al., SPIE Press, 2007
`
`Fairchild Semiconductor Datasheet, 2001
`
`OSRAM BioMon Sensor Datasheet, 2016
`
`2057-2058 Expunged
`
`2059
`
`“Fine Ceramics for Electronics,” Kyocera, 2021
`
`2060
`
`“Thermal Properties of Metals, Conductivity, Thermal
`Expansion, Specific Heat,” Engineers Edge, available at
`https://www.engineersedge.com/properties_of_metals.htm
`
`Exhibit List, Page 2
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`“Thermal Properties of Non-Metals,” Engineers Edge, available
`at https://www.engineersedge.com/heat_transfer/thermal_
`properties_of_nonmetals_13967.htm
`
`“Metals – Specific Heats,” The Engineering ToolBox, available
`at https://www.engineeringtoolbox.com/specific-heat-metals-
`d_152.html
`
`“Heat Capacities for Some Select Substances,” University of
`Texas, available at https://gchem.cm.utexas.edu/data/
`section2.php?target=heat-capacities.php
`
`“FR-4,” Wikipedia, available at https://en.wikipedia.org/wiki/
`FR-4
`
`“Talk:FR-4,” Wikipedia, available at
`https://en.wikipedia.org/wiki/Talk:FR-4
`
`“Thermal Conductivity of Solders,” Electronics Cooling,
`available at https://www.electronics-
`cooling.com/2006/08/thermal-conductivity-of-solders/
`
`2067
`
`PCT Pub. No. WO 03/068060 (“Huiku”)
`
`2068 – 2080 RESERVED
`
`2081
`
`Declaration of Micah Young (Withdrawn) (Confidential Version
`Expunged)
`
`2082
`
`Expunged
`
`2083
`
`2084
`
`Masimo Corp. et al. v. Apple Inc., August 18, 2021 Protective
`Order, ITC Inv. No. 337-TA-1276
`
`Masimo Corp. et al. v. Apple Inc., January 10, 2022 Order
`Granting Motion to Amend the Protective Order, ITC Inv. No.
`337-TA-1276
`
`Exhibit List, Page 3
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2085
`
`2086
`
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`November 3, 2022 Email from Dan Smith to Ted Cannon, et al.
`re: Motions to Seal and Protective Order
`
`Proposed Protective Order
`
`Proposed Protective Order (redlined version)
`
`Masimo Corporation, et al. v. Apple Inc., June 30, 2020
`Protective Order, Case No. 8:20-cv-00048-JVS (JDEx) (C.D.
`Cal.)
`
`Order on Motion to Amend Protective Order, ITC Inv. No. 337-
`TA-371
`
`Masimo Corp. et al. v. Apple Inc., Complainants’ Objection to
`Respondent’s Proposed Expert Brian Anthony, Ph.D. and Motion
`for Protective Order to Preclude Access by Brian Anthony to
`Complainants’ Confidential Business Information [Public
`Version], ITC Inv. No. 337-TA-1276
`
`Masimo Corp. et al. v. Apple Inc., Respondent Apple Inc.’s
`Opposition to Complainants’ Motion for Protective Order to
`Preclude Access by Brian Anthony to Complainants’ Confidential
`Business Information [Public Version], ITC Inv. No. 337-TA-
`1276
`
`Masimo Corp. et al. v. Apple Inc., January 18, 2022 Letter from
`Frazier to Hon. Lisa R. Barton, Secretary, U.S. International
`Trade Commission, regarding enclosed Agreement to be Bound
`by Protective Order signed by Brian Anthony, ITC Inv. No. 337-
`TA-1276
`
`2093
`
`Masimo Corp. et al. v. Apple Inc., Final Initial Determination on
`Violation of Section 337, ITC Inv. No. 337-TA-1276
`
`2094
`
`Protective Order
`
`Exhibit List, Page 4
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2095 – 2101 RESERVED
`
`2102
`
`2103
`
`2104
`
`Declaration of Mohamed Diab (Confidential)
`
`December 15, 2005 Rainbow Sensor Simulations (Confidential)
`
` “Signal Extraction & Rainbow Technology,” Masimo, 2005
`(Confidential)
`
`2105
`
`RESERVED
`
`2106
`
`2107
`
`2108
`
`2109
`
`2110
`
`2111
`
`2112
`
`2113
`
`2114
`
`2115
`
`2116
`
`October 22, 2004 Masimo Rainbow Sensor Drawing (early
`rainbow®) (Confidential)
`
`Masimo Rainbow Sensor Drawing (early rainbow®)
`(Confidential)
`
`RESERVED
`
`December 16, 2016 Kyocera Substrate Drawing (Confidential)
`
`November 8, 2018 Rainbow Flex Circuit Drawing (Confidential)
`
`February 9, 2006 Rainbow Flex Circuit Drawing (Confidential)
`
`2007 Masimo MX-3 Board System Design (Confidential)
`
`2007 Masimo MX-3 Board Product Design Requirements,
`Revision A (Confidential)
`
`2010 Masimo MX-3 Board Product Design Requirements,
`Revision B (Confidential)
`
`2015 Masimo MX-3 Board Product Design Requirements,
`Revision F (Confidential)
`
`Masimo Rainbow Sensor Substrate, Exploded View
`(Confidential)
`
`Exhibit List, Page 5
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`
`“Material Qualification Henkel 84-1LMISR4 Die Attach
`Adhesive,” Masimo
`
`PVIC ACE34560 Electrically Conductive Oven Cure Die Attach
`Adhesive Technical Data Sheet, Protavic Korea Co., Ltd.
`(Confidential)
`
`April 22, 2021 Masimo Rainbow Sensor Photographs (current
`rainbow ®) (Confidential)
`
`March 30, 2009 Masimo Rainbow Sensor Solder Drawing
`(Confidential)
`
`Masimo Rainbow Sensor Photograph (early rainbow ®)
`(Confidential)
`
`2122-2126 RESERVED
`
`2127
`
`December 5, 2008 Masimo Rainbow Sensor Substrate Drawing
`(current rainbow®) (Confidential)
`
`2128
`
`Characterization Station Results (Confidential)
`
`2129
`
`2130
`
`Masimo Rainbow Sensor Finger Assembly Photograph, Top Side
`(current rainbow®)
`
`Masimo Rainbow Sensor Finger Assembly Photograph, Bottom
`Side (current rainbow®)
`
`2131
`
`Masimo Rainbow Research File, 2003 (Confidential)
`
`2132
`
`2133
`
`Masimo Rainbow Sensor Thermal Mass Drawing (current
`rainbow®) (Confidential)
`
`January 30, 2006 Masimo Rainbow Products System Design
`(Confidential)
`
`2134
`
`Excerpt of Masimo source code (Confidential)
`
`Exhibit List, Page 6
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2135
`
`2136
`
`2137
`
`2138
`
`2139
`
`2140
`
`Simulation output for early rainbow® sensor – transient
`temperature
`
`Simulation output for early rainbow® sensor – steady-state
`temperature-distribution map – cross-section
`
`Simulation output for early rainbow® sensor – steady-state
`temperature-distribution map – top surface
`
`Simulation output for early rainbow® sensor – transient
`temperature
`
`Simulation output for early rainbow® sensor – steady-state
`temperature-distribution map – cross-section
`
`Simulation output for early rainbow® sensor – steady-state
`temperature-distribution map – top surface
`
`2141-2150 RESERVED
`
`2151
`
`2152
`
`Declaration of William P. King, Ph.D. (Confidential)
`
`Curriculum Vitae of William P. King, Ph.D.
`
`2053-2056 RESERVED
`
`2157
`
`2158
`
`2159
`
`2160
`
`’127 Patent Claim Coverage Chart – Current Rainbow® Sensors
`(Confidential)
`
`’127 Patent Claim Coverage Chart – Early Rainbow® Sensors
`(Confidential)
`
`Excerpts from Heat Transfer, 2nd ed., A.F. Mills; Prentice Hall,
`1999
`
`Excerpts from Fundamentals of Heat and Mass Transfer, 3rd ed.,
`F.P. Incropera & D.P. DeWitt; John Wiley & Sons, 1990
`
`Exhibit List, Page 7
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2161
`
`Excerpts from Design and Analysis of Heat Sinks, A.D. Kraus &
`A.B. Cohen; John Wiley & Sons, 1995
`
`2162
`
`May 5, 2023 Transcript of Deposition of Brian Anthony, Ph.D.
`
`2163
`
`Excerpt from February 18, 2022 Transcript of ITC Deposition of
`Yassir Abdul-Hafiz
`
`2164-2180 RESERVED
`
`2181
`
`Declaration of Micah Young (Confidential)
`
`2182
`
`Masimo Rainbow Sensor Revenue Excel Spreadsheet
`(Confidential)
`
`
`
`
`
`Exhibit List, Page 8
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`Masimo submits this Patent Owner Response to Apple’s IPR Petition of U.S.
`
`Patent No. 7,761,127 (“the ’127 patent”). Masimo withdraws the declarations filed
`
`with the Patent Owner Preliminary Response (EX2002, 2051, and 2081).
`
`I.
`INTRODUCTION AND TECHNOLOGICAL BACKGROUND
`A.
`Pulse Oximetry
`Masimo is the industry leader in pulse oximetry, a technology for
`
`noninvasively measuring physiological parameters such as oxygen saturation
`
`(“SpO2”). Figure 1 of the ’127 patent depicts a pulse oximeter with a sensor on a
`
`patient’s finger.
`
`EX2102 ¶6; EX1001, Fig. 1. In a typical pulse oximeter, the assembly that attaches
`
`to a patient’s finger contains a sensor with: (1) two light sources, generally LEDs,
`
`and (2) a light detector:
`
`
`
`-1-
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`
`
`
`
`Top of sensor
`
`Bottom of sensor
`
`EX2102 ¶7.
`
`For a pulse oximetry oxygen-saturation measurement, a sensor’s LEDs
`
`typically transmit red and infrared light into the patient’s finger. Id. ¶8. Some of
`
`the transmitted light is absorbed by the tissue and pulsating blood in the finger. Id.
`
`Bright red oxygenated blood absorbs light differently than dark red deoxygenated
`
`blood. Id. After the light passes through the tissue, a light detector in the sensor
`
`measures the light intensity (i.e, amplitude) from both wavelengths. Id. The picture
`
`below generally illustrates the amplitudes of detected red and infrared signals over
`
`time.
`
`-2-
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`
`
`
`EX2151 ¶28. The ratio of the amplitudes of the detected red signal to the detected
`
`infrared signal indicates the oxygen-saturation level. EX2102 ¶8. Pulse oximeters
`
`typically have a “calibration curve” that correlates the red-to-infrared signal ratios
`
`to SpO2 values. Id. This curve reflects empirical data of ratios to invasively
`
`measured oxygen-saturation values from a blood draw. Id. Accurate measurements
`
`require an accurate calibration curve based on the actual LED wavelengths during
`
`operation of the sensor. Id.
`
`B.
`Temperature-Induced Wavelength Shift
`An LED’s wavelength can shift during operation due to an internal LED’s
`
`“p-n junction temperature” change. EX2053, 83; EX2067, 19:1-3.1 Masimo’s
`
`expert, Dr. William P. King, explains the physics of how the LED wavelengths vary
`
`with the p-n junction temperature. EX2151 ¶¶31-33. Temperature-induced
`
`
`1 All emphasis added unless noted.
`
`-3-
`
`
`
`IPR2022-01299
`Apple Inc. v. Masimo Corporation
`wavelength shift can introduce significant error into pulse-oximetry measurements.
`
`Id. ¶34.
`
`Because temperature-induced wavelength shift could be a problem, the prior
`
`art proposes solutions. Id. ¶36. One solution was placing a temperature sensor near
`
`the LEDs and using the measured ambient temperature to approximate LED junction
`
`temperatures and estimate the LED operating wavelengths. See, e.g., id. ¶¶42-43
`
`(discussing Cheung). Because junction temperature changes cause wavelength shift,
`
`a POSITA would have expected the ambient temperature right next to an LED to
`
`approximate the LED’s junction temperature. See id. Consistent with this
`
`expectation, both of Apple’s cited prior art references that use a temperature sensor
`
`to address wavelength shift place it very near the LEDs so that it measures the LED
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`temperature or the nearby ambient temperature. See, e.g., id. ¶¶42-46 (discussing
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`Cheung and Noguchi). Noguchi discloses a control system that uses the temperature
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`measured by a single temperature sensor near a single LED to adjust the LED drive
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`current to control the LED’s wavelength and prevent or reduce wavelength shift. Id.
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`¶¶44-46. Noguchi’s Figure 2 shows the temperature sensor 12 placed near the LED
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`11.
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`EX1008, Fig. 2 (annotated). Because Noguchi’s temperature sensor is very near the
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`LED, it measures the “temperature of the LED itself or the surrounding ambient
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`temperature.” Id., 2:2-4.
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`Cheung also discloses using a temperature sensor 50 placed near its two LEDs
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`40 and 42 to compensate for wavelength shift. EX2151 ¶¶42-43.
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`EX1007, Fig. 11 (annotated). Cheung’s “temperature sensor 50 indicates a change
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`in the ambient temperature.” Id., 19:31-33. But unlike Noguchi, Cheung does not
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`attempt to keep wavelengths constant to reduce wavelength shift. EX2151 ¶¶42-43.
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`Instead, Cheung uses an approach that is generally called wavelength-shift
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`compensation. Id. Wavelength-shift compensation recognizes that LED-junction
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`temperatures change LED wavelengths. Id.; see also id. ¶38. Wavelength-shift
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`compensation estimates the shifted LED wavelengths based on estimates of junction
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`temperatures. Id. Cheung estimated LED wavelength shift based on ambient
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`temperature and then determined physiological parameters. Id.
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`Despite these teachings, multiple prior-art references, including Webster
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`(describing Cheung) and Huiku, discouraged the use of temperature sensors as
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`unreliable and encouraged the use of alternative methods. EX2151 ¶¶47-51.
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`C. The Claimed Invention
`The invention of the ’127 patent uses a different form of wavelength-shift
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`compensation. The invention does not attempt to directly measure LED
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`temperatures or the ambient temperature near the LEDs. EX2151 ¶56. Rather, it
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`measures a temperature at one location of a thermal mass formed from multiple
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`metallized layers thermally coupled to the LEDs. EX1001, 10:62-11:15, claim 7. It
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`uses that one measured temperature to correlate to temperatures for multiple LEDs
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`and to estimate multiple LED wavelengths. Id., see also id., 10:32-39; EX2102 ¶47.
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`No pre-’127-patent evidence suggests measuring the temperature of a thermal mass
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`or using that one measured temperature of the thermal mass to estimate multiple
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`LED wavelengths. See, e.g., EX2151 ¶177.
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`The invention arose from Masimo’s years of research on the feasibility of non-
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`invasively measuring carboxyhemoglobin (HbCO). EX2102 ¶¶16-21. After
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`extensive experimentation, Masimo concluded it was feasible to measure
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`carboxyhemoglobin, methemoglobin, and total hemoglobin. Id. ¶17. To measure
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`these parameters, Masimo used eight or more wavelengths of light, rather than the
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`two wavelengths used for oxygen saturation. Id. ¶18. The technology is called
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`rainbow® because the sensors use many colors or wavelengths of light. Id. But
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`using additional wavelengths alone was not enough to achieve the desired accuracy.
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`Id. ¶¶19-22.
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`In 2003, Masimo could measure HbCO with an error of about six percent but
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`needed better accuracy before offering it commercially. Id. Diab discovered that
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`temperature-induced wavelength shift contributed to the error. Id. ¶¶24-30. Masimo
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`considered using multiple
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`thermistors
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`to directly measure LED
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`junction
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`temperatures to calculate the wavelength shift of each LED. Id. ¶¶32-34. While that
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`seemed to be a solution, it proved to be impractical. Id. ¶¶35. Indeed, it is difficult
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`to accurately measure the junction temperature of even a single LED. Id. A multi-
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`LED sensor greatly compounds this difficulty because each LED will have a
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`different junction temperature. Id.
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`Masimo engineer Mohamed Diab hypothesized a novel approach: estimating
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`all wavelengths of the multiple LEDs by using a single temperature sensor to
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`measure a single temperature of a thermal mass formed of metal layers thermally
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`coupled to the LEDs and the temperature sensor. Id. ¶36. Despite it being his idea,
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`Diab was skeptical it would work because he knew each LED would have a different
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`junction temperature and thus a different wavelength shift. Id. ¶38. He knew a single
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`temperature measurement could not match all junction temperatures and suspected
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`it may be impossible to estimate all LED wavelengths using a single temperature.
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`Id.
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`Diab persevered, conducting hundreds of computer simulations before finding
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`a configuration of metal layers, LEDs, and thermistor that provided estimates of the
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`LED operating wavelengths within 0.1 nanometer. Id. ¶¶40, 54. The simulations
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`produced temperature-distribution maps such as the following:
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`Id. ¶41; EX2003, 1 (annotated). This map shows good thermal conductivity between
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`the thermal mass and the LEDs. EX2151 ¶58.
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`Masimo also used the simulations to find a design that correlated real-time
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`LED and thermistor temperatures. EX2102 ¶¶43-53. Diab recently conducted
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`simulations showing such correlation between the thermistor temperature and
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`multiple LED temperatures:
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`EX2135 (early rainbow® sensor model); EX2102 ¶44.
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`EX2138 (current rainbow® sensor model); EX2102 ¶51. These graphs show that
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`the thermal mass temperature and the LED temperatures rise at substantially the
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`same rate. EX2102 ¶¶44-49, 51-52. For each LED, the difference between the
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`thermistor temperature and the LED temperature is relatively constant. Id. But the
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`thermal mass temperature does not indicate exact or average LED temperatures. Id.
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`It indicates a temperature correlated with the LED temperatures. Id. The thermal
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`mass temperature needs to change to track the changing LED temperatures and to
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`maintain this correlation. Id.
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`The simulations established the surprising result that a single temperature of
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`the thermal mass—which will not match any of the LED junction temperatures—
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`was usable to estimate the wavelengths of the multiple LEDs. Id. ¶¶37-38. Masimo
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`verified these simulations with tests on physical sensors. Id. ¶¶54-55. The tests
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`measured actual LED operating wavelengths with a spectrophotometer and the
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`estimated wavelengths based on the thermal mass temperature. Id. Masimo
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`confirmed its algorithm’s estimated wavelengths matched the actual wavelengths
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`within 0.1 nanometers. Id. Thus, in 2005, Masimo launched the first and still only
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`light-based medical sensor that noninvasively measures carboxyhemoglobin,
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`thereby allowing early detection of carbon monoxide poisoning. Id. ¶¶11-15.
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`Masimo tests every production rainbow® sensor to insure it accurately
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`estimates the wavelengths. The below output plot shows the accuracy of the sensor’s
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`wavelength estimation as a function of temperature.
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`Id. ¶55. The plot compares the actual LED wavelengths emitted by an LED, as
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`measured by a spectrophotometer, with wavelengths estimated by Masimo’s
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`algorithm for that LED at different temperatures intentionally induced while
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`calibrating the sensor. Id. The closeness of the data points to the diagonal identity
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`line shows that the estimated wavelengths are very accurate. Id. The tests are done
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`for each sensor LED so the accuracy of wavelength estimation is verified for each
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`LED. Id.
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`Masimo’s invention cut the measurement error in the rainbow® sensors in
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`half, to nearly three percent. Id. ¶56. This improvement allowed Masimo to
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`commercially launch the rainbow® technology to measure carboxyhemoglobin,
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`methemoglobin, and total hemoglobin and has driven the commercial success the
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`rainbow® sensors have achieved. Id.
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`The ’127 patent’s Figure 12 illustrates simplified aspects of the invention.
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`EX1001, Fig. 12 (simplified, annotated); EX2102 ¶62; EX2151 ¶60. The light
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`emitters (yellow) on the substrate emit optical radiation (light) and transfer thermal
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`energy (heat) to the thermal mass of the substrate (orange). EX2102 ¶62. A
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`temperature sensor (green) on the substrate is also connected to the thermal mass of
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`the substrate. Id. The temperature sensor measures a “bulk temperature” (“T = Tb”).
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`Id. The sensor uses the bulk temperature to estimate all LED wavelengths. EX1001,
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`10:22-48. The ’127 patent explains the thermal mass stabilizes the bulk temperature
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`so it is “meaningful” for estimating LED wavelengths. Id., 10:67-11:4. The Board
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`found, in view of this intrinsic record, that “a ‘meaningful’ temperature reading in
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`the context of the ’127 patent [is] one on a scale relevant to estimating LED
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`wavelengths.” Inst. Dec., 18.
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`Figure 12 conceptually depicts aspects of the invention while abstracting out
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`a great deal of intricacy involved in the temperature changes of the mass. To
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`function as a “thermal mass,” a mass achieves a sufficiently optimal combination of
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`at least: (1) thermal conductivity, (2) heat capacity, and (3) mass. EX2151 ¶124;
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`EX2162, 150:7-21. Changing one attribute will affect the others, so there is no easily
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`predictable way to change just one attribute to achieve the appropriate temperature-
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`change resistance. EX2151 ¶124. Even external factors, such as relative placement
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`of the thermistor and LEDs, can affect whether the mass functions as a “thermal
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`mass.” Id.
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`Conceptually, the thermal mass performs a complex function. Id. ¶94. The
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`inputs to the thermal mass are the heat from multiple LEDs. Id. The thermal mass
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`distributes the heat based on complex heat flow dynamics. Id. The output is a single
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`bulk temperature. Id. The figure below attempts to capture these concepts:
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