Filed on behalf of:
`Patent Owner Masimo Corporation
`By: Brian C. Claassen (Reg. No. 63,051)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Daniel Kiang (Reg. No. 79,631)
`Jeremiah S. Helm, Ph.D. (admitted pro hac vice)
`
`
`
`
`
`
`
`Filed: May 26, 2023
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail:
`AppleIPR745-3@knobbe.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2022-01465
`U.S. Patent 10,687,745
`
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`Patent Owner Masimo Corporation
`By: Brian C. Claassen (Reg. No. 63,051)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Daniel Kiang (Reg. No. 79,631)
`Jeremiah S. Helm, Ph.D. (admitted pro hac vice)
`
`
`
`
`
`
`
`Filed: May 26, 2023
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail:
`AppleIPR745-3@knobbe.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2022-01465
`U.S. Patent 10,687,745
`
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION .................................................................................... 1
`
`II. BACKGROUND ...................................................................................... 4
`
`A. Overview of the Technology .......................................................... 4
`
`B.
`
`C.
`
`D.
`
`The Industry Recognized Masimo’s Excellence in
`Physiological Monitoring ............................................................... 5
`
`The ’745 Patent .............................................................................. 6
`
`Level of Ordinary Skill in the Art .................................................. 9
`
`III. CLAIM CONSTRUCTION ..................................................................... 9
`
`IV. GROUNDS 1A AND 1B FAIL TO ESTABLISH
`OBVIOUSNESS ..................................................................................... 15
`
`A. Apple Does Not Establish a Motivation for Adding a
`“surface comprising a dark-colored coating” to Iwamiya
`(Claims 2-6, 8, 10-12, 14, 21-26) ................................................. 16
`
`B.
`
`The Combination Does Not Disclose a Plurality of
`Photodiodes “arranged in an array having a spatial
`configuration corresponding to a shape of the portion of the
`tissue measurement site encircled by the light block”
`(Claims 6, 17, 19, 26) ................................................................... 23
`
`C. Apple Fails to Demonstrate that Claim 2 Would Have Been
`Obvious......................................................................................... 28
`
`1.
`
`Iwamiya Teaches Away from Sarantos and the
`Combination Would Be Inoperable ................................... 29
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`2.
`
`3.
`
`Sarantos Does Not Explain How to Successfully Use
`Red and Infrared Lights in Its Sensor ................................ 35
`
`A POSITA Would Not Have Reasonably Expected
`Success in Combining Iwamiya with Sarantos to Add
`Oxygen Saturation Measurements ..................................... 36
`
`D. Apple Fails to Demonstrate “the second shape comprises a
`width and a length, and wherein the width is different from
`the length” (Claim 25) .................................................................. 40
`
`V. GROUNDS 2A-2C FAIL TO DEMONSTRATE OBVIOUSNESS ..... 42
`
`A. Apple Fails to Show a “First Shape” and a Different
`“Second Shape” (Claims 2-6, 8, 10-14, 19, 21-26) ...................... 43
`
`B. Apple Fails to Demonstrate a Motivation to Combine
`Sarantos with Shie with a Reasonable Expectation of
`Success (All Challenged Claims) ................................................ 45
`
`C. Apple Fails to Identify a “light block having a circular
`shape” in the Proposed Combinations (All Claims that
`Depend from 15) .......................................................................... 54
`
`D. Apple Failed to Show that Claims 12 and 25 Would Have
`Been Obvious ............................................................................... 56
`
`1.
`
`2.
`
`Apple Did Not Demonstrate that a Cylindrical Lens
`Would Result in a Second Shape with a Length and a
`Different Width (Claim 25) ............................................... 56
`
`Apple Failed to Explain Why a POSITA Would Have
`Used a Cylindrical Lens (Claim 25) .................................. 58
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`3.
`
`4.
`
`Apple Fails to Demonstrate a “Second Shape”
`Different than the “First Shape” for Claim 12 ................... 60
`
`Apple Failed to Explain a Motivation to Combine
`Sarantos, Shie, and Savant (Claim 12) .............................. 61
`
`E.
`
`Apple Failed to Demonstrate that the Plurality of
`Photodiodes Are in the Claimed Array (Claims 6, 17, 19,
`26) ................................................................................................. 62
`
`VI. CONCLUSION ....................................................................................... 64
`
`
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Arendi S.A.R.L. v. Apple Inc.,
`832 F.3d 1355 (Fed. Cir. 2016) ................................................................... 25
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) ..................................................................... 11
`
`Chemours Co. FC, LLC v. Daikin Indus.,
`4 F.4th 1370 (Fed. Cir. 2021) ...................................................................... 34
`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) ....................................................................... 34
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ................................................................... 22
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................... 17, 54
`
`Mallinckrodt, Inc. v. Masimo Corp.,
`No. 2:00-cv-06506, 2004 U.S. Dist. LEXIS 28518 (C.D. Cal.
`2004), aff’d in part and rev’d in part, reh’g en banc denied, 147 F.
`App’x 158 (Fed. Circ. 2005), cert. dismissed, 546 U.S. 1162
`(2006) ............................................................................................................. 6
`
`Masimo Corp v. Philips Elec. N. Am. Corp.,
`No. 1:09-cv-00080, 2015 WL 2379485 (D. Del. May 18, 2015) .......... 6, 7, 8
`
`New Hampshire v. Maine,
`532 U.S. 742 (2001) ..................................................................................... 45
`
`O2 Micro Int’l v. Beyond Innovation Tech. Co. Ltd.,
`521 F.3d 1351 (Fed. Cir. 2008) ................................................................... 13
`
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................... 46, 57
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................. 10, 13
`
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ........................................................ 59, 60
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ............................................................. 32, 33
`
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) ................................................................... 54
`
`Tec Air, Inc. v. Denso Mfg. Michigan Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) ................................................................... 34
`
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d 1352 (Fed. Cir. 2019) ............................................................. 48, 58
`
`Treehouse Avatar LLC v. Valve Corp.,
`54 F.4th 709 (Fed. Cir. 2022) ...................................................................... 15
`
`Wasica Finance GmbH v. Continental Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ................................................................... 11
`
`Xerox,
`IPR2022-00624, Paper 9 .................................................................. 17, 47, 48
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.6 ................................................................................................ 66
`
`37 C.F.R. § 42.8 ................................................................................................ 65
`
`37 C.F.R. § 42.24 .............................................................................................. 65
`
`37 C.F.R. § 42.65 .............................................................................................. 47
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Consolidated Trial Practice Guide (Nov. 2019) ............................................... 14
`
`
`
`-vi-
`
`
`
`
`
`
`
`EXHIBIT LIST
`
`Exhibit
`No.
`2001 Declaration of Jeremiah S. Helm in Support of Pro Hac Vice Motion
`
`Description
`
`2002 Declaration of Professor R. James Duckworth, Ph.D.
`
`2003 Curriculum Vitae of Professor R. James Duckworth, Ph.D.
`
`2004
`
`2005
`
`2006
`
`Y. Mendelson et al., “A wearable reflectance pulse oximeter for
`remote physiological monitoring,” Proceedings of the 28th IEEE
`EMBS Annual International Conference, pp. 912-915, 2006
`
`R.J. Duckworth et al., “Field Testing of a Wireless Wearable
`Reflectance Pulse Oximeter,” American Telemedicine Association
`Annual Conference, 2006
`
`Y. Mendelson, “Wearable Wireless Pulse Oximetry for Physiological
`Monitoring,” Worcester Polytechnic Institute Precise Personnel
`Location Workshop, 2008
`
`2007 RESERVED
`2008 Masimo Corp. et al. v. Apple Inc., June 6-10, 2022 Public Hearing
`Transcript, ITC Inv. No 337-TA-1276
`
`2009-
`2010 RESERVED
`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 Masimo Corp. et al. v. Apple Inc., Masimo’s August 18, 2022 Motion
`to Modify Protective Order, ITC Inv. No 337-TA-1276
`
`2013
`
`Masimo Corp. et al. v. Apple Inc., Apple’s August 29, 2022 Opposition
`to Masimo’s Motion to Modify Protective Order, ITC Inv. No 337-TA-
`1276
`
`Exhibit List, Page 1
`
`
`
`
`
`
`
`
`
`Exhibit
`Description
`No.
`2014 Masimo’s September 20, 2022 Email to Board Requesting
`Authorization to File Motions for Additional Discovery
`2015 Apple’s September 19, 2022 Email to Masimo Opposing Masimo’s
`Request for Additional Discovery
`
`2016-
`2018
`
`RESERVED
`
`2019 U.S. Patent Pub. No. 2017/0325744
`
`2020
`
`January 3, 2013 Masimo Press Release Regarding iSpO2
`
`2021 October 2, 2013 Marcelo Lamego Email to Apple CEO Tim Cook
`
`2022 U.S. Patent No. 10,524,671
`
`2023 U.S. Patent No. 10,247,670
`
`2024 U.S. Patent No. 11,009,390
`
`2025 U.S. Patent No. 10,219,754
`
`2026 RESERVED
`2027 Masimo Corp. et al. v. Apple Inc., Public Order Regarding Masimo’s
`Motion for Preliminary Injunction, Case No. 8:20-cv-00048 (C.D. Cal.)
`
`2028 Apple Webpage Titled “Apple Watch Series 6”
`
`2029 Apple Watch Series 6 Video
`2030-
`2049 RESERVED
`2050 Respondent Apple Inc.’s Post-Hearing Brief (publicly filed July 13,
`2022 in the Investigation)
`
`Exhibit List, Page 2
`
`
`
`
`
`
`
`
`
`Exhibit
`Description
`No.
`2051 Complainants’ Reply Post-Hearing Brief (publicly filed July 25, 2022
`in the Investigation)
`2052 Respondent Apple Inc.’s Corrected Pre-Hearing Brief (publicly filed
`May 27, 2022 in the Investigation)
`
`2053
`
`2054
`
`2055
`
`February 23, 2022 Updated Joint Proposed Claim Construction Chart,
`filed in the Investigation
`
`January 27, 2022 Complainants’ Opening Claim Construction Brief,
`filed in the Investigation
`
`February 10, 2022 Respondent Apple Inc.’s Rebuttal Markman Brief,
`filed in the Investigation
`
`2056 Excerpts of the File History of App. No. 16/532,065
`
`2057 Excerpts of the File History of App. No. 15/195,199
`2058 August 31-September 27, 2022 Email Chain between Masimo’s
`counsel and Apple’s counsel regarding Petition correction
`
`2059
`PCT Publication WO 02/28274
`2060 Redlined comparison of text of Mendelson-799 and PCT Publication
`WO 02/28274
`
`2061 U.S. Pat. App. Pub. No. 2014/0107493
`
`2062
`
`September 15, 2020 Apple Press Release Regarding Apple Watch
`Series 6
`
`2063
`
`Andrew Griffin, “Apple Watch Series 6: Why Apple Added a Sensor to
`Tell How Much Oxygen Is in Your Blood as Its Big New Feature –
`And What It Means,” Independent, Oct. 7, 2020
`(https://www.independent.co.uk/tech/apple-watch-series-6-blood-
`oxygen-pulse-oximetry-red-light-heart-rate-vo2-max-b513807.html)
`
`Exhibit List, Page 3
`
`
`
`
`
`Exhibit
`No.
`
`2064
`
`
`
`
`
`Description
`
`Brian Chen, “The New Apple Watch Measures Your Blood Oxygen.
`Now What?,” New York Times, Sept. 17, 2020
`(https://www.nytimes.com/2020/09/17/technology/personaltech/new-
`apple-watch-blood-oxygen-level-review.html)
`
`2065 Excerpts of Webster’s New Collegiate Dictionary (1980)
`
`2066 Masimo 2014 Annual Report
`2067 Marcelo Lamego LinkedIn Profile
`(https://www.linkedin.com/in/marcelo-lamego-72564454)
`
`2068
`
`Findings of Fact & Conclusions of Law, Masimo Corp. v. True
`Wearables, Inc., No. 8:18-cv-02001-JVS-JDE, Dkt. 600 (C.D. Cal.
`Nov. 7, 2022)
`2069 Eric W. Weisstein, Annulus, Wolfram MathWorld (Dec. 1, 2022, 3:20
`PM), https://mathworld.wolfram.com/Annulus.html
`2070 Declaration of Professor R. James Duckworth, Ph.D. in Support of
`Masimo’s Patent Owner Responses
`2071 Transcript of March 24, 2023 Deposition of Dr. Brian W. Anthony and
`Exhibits 1-3 Thereto
`
`2072 Excerpt of Webster’s II New College Dictionary (2001)
`2073 Encyclopedia Britannica, Light, the visible spectrum,
`https://www.britannica.com/science/light (last visited May 19, 2023)
`
`2074
`
`2075
`
`Nonconfidential Excerpt of Page 65 from June 6-10, 2022 Hearing
`Transcript, Masimo Corp. et al. v. Apple Inc., ITC Inv. No 337-TA-
`1276
`
`February 13, 2023 Respondent Apple Inc.’s Response to Complainants’
`Petition for Review (Public Version), filed in Masimo Corp. et al. v.
`Apple Inc., ITC Inv. No 337-TA-1276
`
`Exhibit List, Page 4
`
`
`
`
`
`Exhibit
`No.
`
`2076
`
`2077
`
`2078
`
`
`
`
`
`Description
`
`CONFIDENTIAL – Transcript of Testimony of Brian Land from June
`6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple Inc., ITC
`Inv. No 337-TA-1276
`
`CONFIDENTIAL – Transcript of Testimony of Dr. Paul Mannheimer
`from June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple
`Inc., ITC Inv. No 337-TA-1276
`
`CONFIDENTIAL – Transcript of Testimony of Dr. Stephen Waydo
`from June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple
`Inc., ITC Inv. No 337-TA-1276
`
`2079
`
`CONFIDENTIAL – Transcript of Testimony of Dr. Vivek Venugopal
`from June 6-10, 2022 Hearing Transcript, Masimo Corp. et al. v. Apple
`Inc., ITC Inv. No 337-TA-1276
`2080 CONFIDENTIAL – ITC Exhibit CX-0289C – Designated Portions of
`February 10, 2022 Deposition of Paul Mannheimer
`2081 CONFIDENTIAL – ITC Exhibit CX-0299C – Designated Portions of
`February 18, 2022 Deposition of Stephen Waydo
`2082 CONFIDENTIAL – ITC Exhibit CX-0295C – Designated Portions of
`February 11, 2022 Deposition of Tao Shui
`2083 CONFIDENTIAL – ITC Exhibit CX-0007C – Email from Brian Land
`to Paul Mannheimer et al.
`2084 CONFIDENTIAL – ITC Exhibit CX-0175C – Apple Organization
`Chart
`
`2085 CONFIDENTIAL – ITC Exhibit CX-0177C – Apple Presentation
`
`2086 CONFIDENTIAL – ITC Exhibit CX-0185C – Apple Presentation
`
`Exhibit List, Page 5
`
`
`
`
`
`Exhibit
`No.
`
`2087
`
`
`
`
`
`Description
`
`Kim, Gina, “Masimo Wants $3B From Apple Over Smartwatch IP,
`Jury Told.” Law360, April 5, 2023
`(https://www.law360.com/articles/1593689/masimo-wants-3b-from-
`apple-over-smartwatch-ip-jury-told)
`
`2088
`
`ITC Exhibit CX-1616 – Fowler, Geoffrey, “The new Apple Watch says
`my lungs may be sick. Or perfect. It can’t decide.” Washington Post,
`September 23, 2020 (https://www.washingtonpost.com/technology/202
`0/09/23/apple‐watch‐oximeter/)
`
`2089 CONFIDENTIAL – ITC Exhibit CX-1793C – Apple Presentation
`2090 CONFIDENTIAL – ITC Exhibit CX-1800C – Email from Adrian
`Perica to Steve Hotelling, et al.
`
`2091
`
`William, Andrews, “Fitbit Update Lets You Quickly Check Your
`Blood Oxygen Saturation.” Forbes, Sept. 9, 2020
`(https://www.forbes.com/sites/andrewwilliams/2020/09/09/fitbit-
`update-lets-you-quickly-check-your-blood-oxygen-
`saturation/?sh=5d6ecb55e76a)
`
`2092
`
`“Track Your SpO2 to Uncover Changes in Your Wellbeing,” Fitbit,
`Sept. 7, 2020 (https://blog.fitbit.com/track-your-spo2/)
`
`2093 CONFIDENTIAL – ITC Final Initial Determination
`
`2094 RESERVED
`
`
`
`
`
`Exhibit List, Page 6
`
`
`
`
`
`
`
`I. INTRODUCTION
`
`Apple’s Petition challenges dependent claims of U.S. Patent No. 10,687,745
`
`(“’745 Patent”) by treating devices in the prior art as a collection of components that
`
`could be shuffled around in hindsight. But Apple’s obviousness grounds rely on
`
`incompatible components from those devices. And to extract those components
`
`Apple disregards the contrary teachings in the references. Apple also fails to
`
`establish a motivation to combine the collection of components and even ignores
`
`certain claim elements outright. Thus, Apple’s hindsight reconstruction fails to
`
`show obviousness of any challenged claim.
`
`Apple also overlooks structures and teachings of the prior art inconvenient to
`
`its argument. For example, Apple argues in Grounds 1A-1B that a POSITA would
`
`have added a “dark-colored coating” from Sarantos to a “light shielding frame” in
`
`Iwamiya. But Apple fails to present any rational reason to do so. Apple assumes
`
`that Iwamiya’s “light shielding frame” could not shield light itself. Worse, Iwamiya
`
`repeatedly teaches that light shielding should be accomplished using reflective
`
`materials. Apple does not even acknowledge those teachings or present any reason
`
`to depart from them. No teaching from the prior art suggests that a “dark-colored
`
`coating” from Sarantos would somehow improve the “light shielding frame” from
`
`Iwamiya. Instead, Apple implicitly assumes that Iwamiya had a problem and ignores
`
`that Iwamiya had already solved it.
`
`-1-
`
`
`
`Apple also never acknowledges the incompatibility of Iwamiya and Sarantos.
`
`
`
`
`
`
`
`Iwamiya was particularly concerned about weak signal strength caused by melanin
`
`in the skin absorbing UV and visible light. Iwamiya dedicated substantial disclosure
`
`to addressing that problem by using infrared light at 940 nm for measuring pulse
`
`waves and filtering out other wavelengths below 900 nm. In contrast, Sarantos’
`
`sensor design was designed for green wavelengths in the 500-600 nm range, and
`
`“not tailored for use in other spectrums, such as the red or infrared spectra.”
`
`EX1005, 18:48-51. Apple fails to address that Iwamiya’s optical filter was designed
`
`to block the very operating wavelengths that it proposes adding from Sarantos.
`
`And Apple does not propose removing Iwamiya’s filter. Rather, Apple relied
`
`specifically on the operation of that filter to block wavelengths below 900 nm to
`
`meet a certain claim element. But Apple cannot have it both ways. That filter would
`
`render its combination inoperable with respect to the second wavelength of light
`
`recited in Claim 2. This inconsistency reveals the hindsight approach to Apple’s
`
`hodgepodge obviousness combination.
`
`Apple’s Grounds 2A-2C fare no better. Apple relies on a combination of
`
`components from Sarantos and Shie. But Apple does not identify what material
`
`from Shie would supposedly be combined with Sarantos. Moreover, many of the
`
`challenged claims require a material that changes a “first shape” of light emitted by
`
`the LEDs into a “second shape.” Apple previously agreed and continues to represent
`
`-2-
`
`
`
`
`to the ITC that the claims require that the “second shape” differ from the “first shape.
`
`
`
`
`
`But Apple presents no evidence or argument that its proposed combination of
`
`Sarantos with Shie would result in a “second shape” different than the “first shape.”
`
`Apple also fails to support its alleged motivations to combine Sarantos with
`
`Shie. Apple argues that its proposed combination would lead to increased power
`
`efficiency and accuracy but offers no contemporaneous evidence supporting that
`
`argument. Apple also fails to establish that a POSITA would have known to use a
`
`material that changes the shape of light to accomplish those goals. Instead, it relies
`
`on an expert declaration that merely repeats the same argument without any further
`
`analysis or evidence.
`
`Apple also had the benefit of fully litigating the validity of the ’745 Patent in
`
`the ITC Investigation before filing this and three other petitions against the ’745
`
`Patent. But even with the benefit of that extensive litigation history, Apple still fails
`
`to articulate a rational, evidence-supported reason why a POSITA would have
`
`combined the prior art without resorting to hindsight. Because Apple fails to
`
`establish the obviousness of any challenged ’745 Patent claim, the Board should
`
`uphold their validity.
`
`-3-
`
`
`
`
`
`II. BACKGROUND
`A. Overview of the Technology
`
`
`
`
`
`Pulse oximetry is a method of noninvasively measuring the proportional
`
`amount of hemoglobin carrying oxygen, called arterial oxygen saturation. EX1013,
`
`16, 23; EX2002, ¶ 54. Pulse oximetry relies on the Beer-Lambert law, which allows
`
`the concentration of oxyhemoglobin and hemoglobin in blood to be calculated by
`
`measuring the absorption of light at known wavelengths. See EX1001, 1:66-2:4; see
`
`also EX1013, 40.1 Pulse oximeters emit light of at least two wavelengths, typically
`
`red and infrared. EX2002, ¶ 54. Red and infrared wavelengths are chosen because
`
`hemoglobin absorbs more red light than oxyhemoglobin, while oxyhemoglobin
`
`absorbs more infrared light than hemoglobin. Id. A detector measures the amount
`
`of light that has passed through the tissue and outputs a photoplethysmography
`
`(PPG) signal for each wavelength of light. Id. at ¶ 55. The relative amounts of red
`
`and infrared light detected during systole and diastole can be used to calculate a ratio
`
`of ratios which can then be mapped to an oxygen saturation value indicating the
`
`proportional amount of hemoglobin carrying oxygen. That is known as oxygen
`
`saturation (SpO2). Id. at ¶¶ 54-55.
`
`
`1 Unless stated otherwise, pincites generally refer to a document’s original
`pagination.
`
`-4-
`
`
`
`The PPG signals obtained by a pulse oximeter can also be used to measure
`
`
`
`
`
`
`
`pulse rate. EX2002, ¶ 55; EX1013, 125. Pulse rate measurements count the number
`
`of pulses in a PPG waveform over time. Id. at 47. Oxygen saturation, however, is
`
`calculated with a more complex algorithm that involves, among other things,
`
`obtaining PPG signals for at least two wavelengths of light, determining how much
`
`of the light absorption in the PPG signals is due to the pulsatile as compared to non-
`
`pulsatile signal components, calculating a ratio of ratios for the red and infrared
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`signals, and empirically mapping the end result to an oxygen saturation value.
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`EX2002, ¶ 55.
`
`B.
`
`The Industry Recognized Masimo’s Excellence in Physiological
`Monitoring
`
`In the late 1980s and early 1990s, pulse oximetry did not work well,
`
`particularly on the sickest patients who needed it most. While the basic principles
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`of pulse oximetry were known, pulse oximeters faced major problems with accuracy
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`caused by patient motion and low perfusion (low blood flow in the tissue
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`measurement site). Masimo developed innovative sensor designs coupled with
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`advanced signal processing to accurately measure physiological parameters such as
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`oxygen saturation, even during patient motion and low perfusion. Masimo spent
`
`decades developing
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`technology for noninvasively measuring physiological
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`parameters. EX2008, 80:10-85:25, 92:24-94:17, EX2066, 4-9. Masimo showed the
`
`world the possibility of measuring oxygen saturation through motion and low
`
`-5-
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`
`
`
`perfusion. EX2008, 84:24-85:16. To achieve that breakthrough, Masimo’s
`
`
`
`
`
`advanced signal processing, improved sensor design, and hardware work together to
`
`extract very tiny physiological signals that are obscured by noise. Id. at 83:18-84:10,
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`88:3-90:4, 98:9-99:16. Eventually, the entire industry respected Masimo’s
`
`intellectual property on these innovations after substantial litigation and appeals.
`
`EX2008, 90:15-91:10; Mallinckrodt, Inc. v. Masimo Corp., No. 2:00-cv-06506,
`
`2004 U.S. Dist. LEXIS 28518 (C.D. Cal. 2004), aff’d in part and rev’d in part, reh’g
`
`en banc denied, 147 F. App’x 158 (Fed. Circ. 2005), cert. dismissed, 546 U.S. 1162
`
`(2006); Masimo Corp v. Philips Elec. N. Am. Corp., No. 1:09-cv-00080, 2015 WL
`
`2379485, at *19 (D. Del. May 18, 2015).
`
`C. The ’745 Patent
`
`The ’745 Patent, which claims priority to a provisional application filed
`
`July 2, 2015, is the result of inventor Ammar Al-Ali’s research on pulse oximetry at
`
`the wrist around 2014 to 2015. EX1001, 2; EX2008, 248:24-249:8. The ’745 Patent
`
`discloses sensor designs with various enhancements that improve signals typically
`
`obscured by noise. EX1001, 7:4-62, 8:54-9:10, 10:40-11:66, Figs. 7A-7B. Those
`
`enhancements improve measurement of SpO2 and other parameters during more
`
`difficult conditions and from more difficult sites including the wrist. Id. at 1:23-27,
`
`2:40-3:4, 10:40-51.
`
`-6-
`
`
`
`For example, many challenged claims depend from Claim 1, which recites a
`
`
`
`
`
`
`
`novel noninvasive physiological monitoring device that measures from a user’s
`
`wrist. The claim features a “material configured to be positioned between the
`
`plurality of light-emitting diodes and tissue on a wrist of a user” and which changes
`
`the shape of light that is emitted from the LEDs from a “first shape” to a “second
`
`shape.” The ’745 Patent explains how using a material to change the shape of light
`
`improved measurement accuracy.
`
`Before the ’745 Patent, pulse oximetry conventionally applied a two-
`
`dimensional analytical model to the three-dimensional space of the tissue
`
`measurement site. EX1001, 5:41-50. In this 2D model, a light source with
`
`negligible dimensions would be considered as a point source and the path of light as
`
`it penetrates the tissue would be considered as a line or vector, representing a two-
`
`dimensional construct. Id. at 5:62-65. Conventional wisdom was that using an
`
`optical point source would reduce the variability in the light pathlength, a variable
`
`in the Beer-Lambert law, which would lead to more accurate pulse oximetry
`
`measurements. Id. at 5:66-6:1; see also EX2002, ¶ 59. A study found, however,
`
`that the difference between the average pathlengths for red and infrared light affects
`
`the calibration curve for a pulse oximeter, thereby decreasing accuracy. EX1001,
`
`6:1-20. Rather than irradiating tissue with a simple point source, Al-Ali departed
`
`from conventional wisdom and applied a three-dimensional model by adding a
`
`-7-
`
`
`
`
`material to change the shape of light emitted towards the user’s tissue to irradiate a
`
`
`
`
`
`larger volume of tissue. Id. at 6:21-7:3; see also EX2002, ¶¶ 60-61. The increased
`
`light interaction led to more accurate oxygen saturation measurements. EX1001,
`
`6:64-7:3.
`
`In conjunction with the material that changes the shape of light, Claim 1 also
`
`features additional structures designed to improve signal quality. For example, the
`
`claim recites a “surface comprising a dark-colored coating” positioned between the
`
`photodiodes and the user’s tissue. The patent explains that the use of a dark-colored
`
`coating can also address a “multiple scattering” problem where emitted light can
`
`reflect back and forth between the user’s tissue and the sensor, leading to
`
`considerably longer photon pathlengths that affect the accuracy of the measurement.
`
`EX1001, 8:54-9:7; EX2002, ¶ 62. The claim also recites a “light block” which can
`
`prevent LED light from reaching the detectors before attenuation by the tissue. See
`
`EX1001, 15:54-57, 10:49-51, 11:10-20, Figs. 7A-7B; EX2002, ¶ 62.
`
`The claimed inventions of the ’745 Patent thus provide novel combinations of
`
`features allowing improved measurement of a user’s physiological parameters, such
`
`as SpO2, at the user’s wrist. See, e.g., EX1001, 10:40-51, Figs. 7A-7B.
`
`Based on Al-Ali’s research and the resulting ’745 Patent inventions, Masimo
`
`developed a commercial medical-grade wrist-based pulse oximeter that is now sold
`
`as the Masimo W1™ watch, pictured below. EX2008, 248:24-250:14.
`
`-8-
`
`
`
`
`
`
`
`
`
`
`
`D. Level of Ordinary Skill in the Art
`
`Apple’s asserted level of ordinary skill in the art is relatively low. Pet., 4-5;
`
`see also EX2002, ¶¶ 31-33; EX2070, ¶ 5. Apple asserts that a POSITA would just
`
`have a bachelor’s degree and a couple years of relevant experience or a master’s
`
`degree with less than a year of relevant experience. Pet., 4-5.
`
`III. CLAIM CONSTRUCTION
`
`“change the first shape into a second shape”
`
`Claims 1 and 20 both recite a “material configured to change the first shape
`
`into a second shape by which the light emitted from one or more of the plurality of
`
`-9-
`
`
`
`
`light-emitting diodes is projected towards the tissue.”2 The plain meaning of
`
`
`
`
`
`“change” is to make different. See EX2072; EX2070, ¶¶ 6-7. Although the phrase
`
`does not require a specific first shape nor second shape, it nevertheless requires those
`
`two shapes are different from each other. EX2070, ¶¶ 6, 11. A mere change in size
`
`does not meet this phrase as illustrated below.
`
`
`
`See EX2070, ¶ 9; see also EX2002, ¶ 44.
`
`Claim phrases are not construed in isolation. Instead, claim language must be
`
`construed as part of the claim as a whole and in the context of the specification and
`
`prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303, 1314-15 (Fed. Cir.
`
`2005) (en banc). Here the claim language as a whole makes explicit that the first
`
`and second shapes must differ. The claim requires that the material is “configured
`
`to change the first shape into a second shape.” The first and second shapes must
`
`therefore be different from each other, otherwise it would render the claim language
`
`
`2 All emphases are added unless stated otherwise.
`
`-10-
`
`
`
`
`“change…into” superfluous and irrelevant. EX2070, ¶ 7. Such a construction is
`
`
`
`
`
`disfavored. Wasica Finance GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272,
`
`1288 n.10 (Fed. Cir. 2017) (“It is highly disfavored to construe terms in a way that
`
`renders them void, meaningless, or superfluous.”) (citing Bicon, Inc. v. Straumann
`
`Co., 441 F.3d 945, 950-51 (Fed. Cir. 2006)).
`
`Indeed, the specification includes several examples of a material changing a
`
`first shape into a second shape. See EX1001, 7:63-8:14 (describing a diffuser that
`
`can “receive emitted light in the form of a point optical source” and “distribut[e] the
`
`emitted light on the surface of a plane (e.g., the surface of the tissue measurement
`
`site 102) in a predefined geometry (e.g., a rectangle, square, or circle)”), 10:65-11:2
`
`(changing the shape of light into a “wide, donut-shaped area”); EX2002, ¶ 36;
`
`EX2070, ¶ 8. Thus, the specification confirms the claims’ plain language that
`
`changing a first shape into a second shape means the two shapes are different. A
`
`mere change in size is not a change in shape.
`
`The prosecution history confirms that a change in size is not a change in shape.
`
`EX2070, ¶ 9. During prosecution of a parent application (App. No. 16/532,065), the
`
`Examiner rejected the claims based on prior art that included a lens that changed the
`
`size but not the shape of the emitted light. See EX2056, 40, 59-60; EX2002, ¶¶ 38-
`
`43; EX2070, ¶ 9. In response, Masimo proposed claim amendments during an
`
`Examiner interview “which reflect a change in shape of emitted light beyond a
`
`-11-
`
`
`
`
`change in size.” See EX2056, 162; EX2002, ¶¶ 40-42. After the interview, the
`
`
`
`
`
`Examiner issued a Notice of Allowability including an approved amendment to
`
`require “the material configured to alter thea first shape into a second shape.”
`
`EX2056, 157; see also EX2002, ¶ 43. That prosecution history thus confirms that
`
`“change the first shape into a second shape” requires more than “a change in size.”
`
`EX2002, ¶ 44; EX2070, ¶ 9.
`
`The Institution Decision did not construe “second shape” because the Board
`
`did not perceive any dispute. Institution Decision, 18. Post-institution discovery
`
`demonstrates that there is a dispute as to claim scope. Masimo’s position, consistent
`
`with the plain language and prosecution history, is that “second shape” in the phrase
`
`“change the first shape into a second shape” requires that the first and second shapes
`
`are different. Apple’s position is that the first and second shapes can be the same
`
`shape. See, e.g., EX2071, 107:18-109:5.
`
`Construction is necessary because Apple relies on its broad understanding in
`
`Grounds 2A-2C. As discussed further below, the Petition includes no evidence that
`
`any “material” in its Sarantos and Shie combinat
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