`
`
`
`Filed: May 26, 2023
`
`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)
`
`
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail:
`AppleIPR745-1@knobbe.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`Case IPR2022-01291
`U.S. Patent 10,687,745
`
`
`
`
`
`
`PATENT OWNER RESPONSE
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`INTRODUCTION .................................................................................... 1
`
`II. BACKGROUND ...................................................................................... 5
`
`A. Overview of the Technology .......................................................... 5
`
`B.
`
`C.
`
`D.
`
`The Industry Recognized Masimo’s Excellence in
`Physiological Monitoring ............................................................... 6
`
`The ’745 Patent .............................................................................. 7
`
`Level of Ordinary Skill in the Art ................................................ 10
`
`III. CLAIM CONSTRUCTION ................................................................... 11
`
`IV. GROUNDS 1A AND 1B FAIL TO ESTABLISH
`OBVIOUSNESS ..................................................................................... 17
`
`A. Apple Fails to Demonstrate that Claims 9 and 18, Which
`Require Measuring Oxygen Saturation at the Wrist, Would
`Have Been Obvious ...................................................................... 17
`
`1.
`
`2.
`
`3.
`
`4.
`
`Iwamiya and Sarantos Do Not Disclose Oxygen
`Saturation Measurements ................................................... 18
`
`A POSITA Would Not Have Combined Iwamiya and
`Sarantos .............................................................................. 21
`
`Apple Fails to Demonstrate a Reasonable
`Expectation of Success in Measuring Oxygen
`Saturation at the Wrist ....................................................... 28
`
`The Testimony of Apple’s Engineers and Its
`Development Documents Confirm that a POSITA
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`Would Not Have Reasonably Expected Success in
`Measuring Oxygen Saturation at the Wrist ........................ 30
`
`5.
`
`Apple “Supplemental Information” Cannot
`Demonstrate a Reasonable Expectation of Success ........... 40
`
`B. Apple Fails to Demonstrate Multiple Elements of Claims 20
`and 27 ........................................................................................... 42
`
`C. A POSITA Would Not Have Been Motivated to Combine
`Iwamiya with Sarantos to Add a Second Wavelength
`(Claim 27) ..................................................................................... 43
`
`D. Apple Does Not Establish a Motivation for Adding a
`“surface comprising a dark-colored coating” to Iwamiya
`(Claims 1, 9, 20, 27) ..................................................................... 44
`
`E.
`
`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 15, 18) ............................................................................. 50
`
`V. GROUNDS 2A AND 2B FAIL TO ESTABLISH
`OBVIOUSNESS ..................................................................................... 53
`
`A. Apple Fails to Show a “First Shape” and a Different
`“Second Shape” (Claims 1, 9, 20, 27) .......................................... 54
`
`B. Apple Fails to Demonstrate a Motivation to Combine
`Sarantos with Shie with a Reasonable Expectation of
`Success (All Challenged Claims) ................................................. 56
`
`C. Apple Fails to Show that Measuring Oxygen Saturation at
`the Wrist Would Have Been Obvious (Claims 9, 18) .................. 64
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`D. Apple Failed to Identify a “light block having a circular
`shape” in the Proposed Combinations (Claims 15, 18) ............... 64
`
`E.
`
`Apple Did Not Address “wherein the plurality of
`photodiodes are arranged in an array having a spatial
`configuration …” (Claims 15, 18) ............................................... 66
`
`VI. CONCLUSION ....................................................................................... 67
`
`
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Arendi S.A.R.L. v. Apple Inc.,
`832 F.3d 1355 (Fed. Cir. 2016) ................................................................... 53
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) ..................................................................... 12
`
`Chemours Co. FC, LLC v. Daikin Indus.,
`4 F.4th 1370 (Fed. Cir. 2021) ...................................................................... 28
`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) ....................................................................... 27
`
`Handi Quilter, Inc. v. Bernina Int’l AG,
`IPR2013-00364, Paper 30 (PTAB June 12, 2014) ...................................... 41
`
`Interconnect Planning Corp. v. Feil,
`774 F.2d 1132 (Fed. Cir. 1985) ................................................................... 31
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ................................................................... 50
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................... 45, 65
`
`Laboratoire Francais Du Fractionnement et des Biotechnologies S.A.
`v. Novonordisk Healthcare AG,
`IPR2017-000028, Paper 22 (PTAB June 13, 2017) .................................... 41
`
`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) ............................................................................................................. 7
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Masimo Corp v. Philips Elec. N. Am. Corp.,
`No. 1:09-cv-00080, 2015 WL 2379485 (D. Del. May 18, 2015) .......... 7, 8, 9
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) ................................................................... 30
`
`New Hampshire v. Maine,
`532 U.S. 742 (2001) ..................................................................................... 55
`
`O2 Micro Int’l v. Beyond Innovation Tech. Co. Ltd.,
`521 F.3d 1351 (Fed. Cir. 2008) ................................................................... 14
`
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................... 21, 56
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................. 11, 14
`
`Rackspace US, Inc. v. PersonalWeb Techs., LLC,
`IPR2014-00057, Paper 16 (PTAB Apr. 30, 2014) ...................................... 41
`
`Santarus, Inc. v. Par Pharm., Inc.,
`694 F.3d 1344 (Fed. Cir. 2012) ................................................................... 25
`
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) ................................................................... 65
`
`Tec Air, Inc. v. Denso Mfg. Michigan Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) ................................................................... 27
`
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d 1352 (Fed. Cir. 2019) ................................................................... 58
`
`Treehouse Avatar LLC v. Valve Corp.,
`54 F.4th 709 (Fed. Cir. 2022) ...................................................................... 16
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Wasica Finance GmbH v. Continental Auto. Sys., Inc.,
`853 F.3d 1272 (Fed. Cir. 2017) ................................................................... 12
`
`Xerox Corp. v. Bytemark, Inc.,
`IPR2022-00624, Paper 9 (PTAB 2022) ..................................... 19, 28, 45, 58
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.65 .............................................................................................. 58
`
`
`
`
`
`-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 RESERVED
`
`2069 RESERVED
`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.
`
`
`
`
`
`Description
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`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
`
`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
`
`CONFIDENTIAL – ITC Exhibit CX-0289C – Designated Portions of
`February 10, 2022 Deposition of Paul Mannheimer
`
`CONFIDENTIAL – ITC Exhibit CX-0299C – Designated Portions of
`February 18, 2022 Deposition of Stephen Waydo
`
`CONFIDENTIAL – ITC Exhibit CX-0295C – Designated Portions of
`February 11, 2022 Deposition of Tao Shui
`
`CONFIDENTIAL – ITC Exhibit CX-0007C – Email from Brian Land
`to Paul Mannheimer et al.
`
`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
`
`2088
`
`
`
`
`
`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)
`
`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 (Public version
`filed at Exhibit 1033)
`
`2094 Comparison of EX1003 with the Petition
`
`
`
`
`
`Exhibit List, Page 6
`
`
`
`
`
`
`
`I. INTRODUCTION
`
`Apple’s Petition challenges the same claims of U.S. Patent No. 10,687,745
`
`(“’745 Patent”) based on the same prior art combinations and arguments that the
`
`parties already litigated in ITC Investigation No. 337-TA-1276 (“Investigation”).
`
`Apple treats 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, as the ITC Administrative Law Judge found.
`
`Apple also fails to demonstrate that a POSITA would have had a reasonable
`
`expectation of success in combining the references to measure oxygen saturation at
`
`the wrist, as required by Claims 9 and 18. Apple argues that “wrist-worn pulse
`
`oximetry sensors … were well-known in the art,” but its own engineers confirmed
`
`otherwise. For example, Brian Land, who leads Apple’s Health Sensing Hardware
`
`team, testified that pulse oximetry at the wrist was “unprecedented” and that
`
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`
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`IPR2022-01291
`
`-1-
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`
`
`1 EX2076, 964:2-6.
`
`
`
`
`
`
`
`As of late 2014—just months before the ’745 Patent was filed in July 2015—
`
`
`
`Apple hired an industry veteran, Dr. Paul Mannheimer, with decades of experience
`
`designing pulse oximeters, to investigate the feasibility of oxygen saturation at the
`
`wrist. His immediate reaction: “Good luck with that.” EX2077, 1012:12-22.
`
`.
`
`EX2080, 174:2-174:6.
`
` Apple’s engineers gave
`
`an internal presentation concluding that “[c]onventional sensing methods do not
`
`result in waveforms that are consistent enough for SpO2 measurements at the
`
`wrist.” EX2085, 13. Instead,
`
`
`
` Id. Apple never
`
`addresses the contrary testimony that it elicited from its own engineers during the
`
`ITC Investigation.
`
`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
`
`
`1 Confidential information is highlighted in yellow.
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`IPR2022-01291
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`-2-
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`
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`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.
`
`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 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
`
`IPR2022-01291
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`-3-
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`
`
`render its combination inoperable because it blocks all visible light, including the
`
`
`
`
`
`red light Apple asserted would be combined with Iwamiya to enable it to measure
`
`oxygen saturation for Claims 9 and 18. This inconsistency reveals the hindsight
`
`approach to Apple’s hodgepodge obviousness combination.
`
`Apple’s Grounds 2A-2B 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
`
`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 repeats the same argument without any further analysis
`
`or evidence.
`
`IPR2022-01291
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`-4-
`
`
`
`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 challenging the ’745
`
`Patent. But despite that extensive litigation history, Apple still is unable to articulate
`
`a rational, evidence-based reason to combine the references. And Apple never
`
`explains why it ignores the contrary testimony of its engineers who struggled for
`
`years to achieve oxygen saturation at the wrist. Because Apple fails to establish the
`
`obviousness of any challenged ’745 Patent claim, the Board should uphold their
`
`validity.
`
`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, ¶ 53. 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 at 40.2 Pulse oximeters emit light of at least two wavelengths, typically
`
`red and infrared. EX2002, ¶ 53. Red and infrared wavelengths are chosen because
`
`hemoglobin absorbs more red light than oxyhemoglobin, while oxyhemoglobin
`
`
`2 Unless stated otherwise, pincites generally refer to a document’s original
`pagination.
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`IPR2022-01291
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`-5-
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`
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`absorbs more infrared light than hemoglobin. Id. A detector measures the light after
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`
`
`
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`it has passed through the tissue and outputs a photoplethysmography (PPG) signal
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`for each wavelength of light. Id. at ¶ 54. The relative amounts of red and infrared
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`light detected during systole and diastole can be used to calculate a ratio of ratios,
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`which can then be mapped to an oxygen saturation value indicting the proportional
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`amount of hemoglobin carrying oxygen. Id. at ¶¶ 53-54.
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`The PPG signals obtained by a pulse oximeter can also be used to measure
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`pulse rate. EX2002, ¶ 77; EX1013, 125. Pulse rate measurements count the number
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`of pulses in a PPG waveform over time. EX2002, ¶ 77. Oxygen saturation,
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`however, is calculated with a more complex algorithm that involves, among other
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`things, obtaining PPG signals for at least two wavelengths of light, determining how
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`much of the light absorption in the PPG signals is due to the pulsatile as compared
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`to non-pulsatile signal components, calculating a ratio of ratios for the red and
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`infrared signals, and empirically mapping the end result to an oxygen saturation
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`value. Id.
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`B.
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`The Industry Recognized Masimo’s Excellence in Physiological
`Monitoring
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`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
`
`of pulse oximetry were known, pulse oximeters faced major problems with accuracy
`
`caused by patient motion and low perfusion (low blood flow in the measurement
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`IPR2022-01291
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`-6-
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`
`
`
`site). Masimo developed innovative sensor designs coupled with advanced signal
`
`
`
`
`
`processing to accurately measure physiological parameters such as oxygen
`
`saturation, even during patient motion and low perfusion. Masimo spent decades
`
`developing technology for noninvasively measuring physiological 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 perfusion.
`
`EX2008, 84:24-85:16. To achieve that breakthrough, Masimo’s advanced signal
`
`processing, improved sensor design, and hardware work together to extract tiny
`
`physiological signals that are obscured by noise. Id. at 83:18-84:10, 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. EX2008, 248:24-249:8. The ’745 Patent discloses
`
`IPR2022-01291
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`-7-
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`
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`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 like the wrist. Id. at 1:23-27, 2:40-
`
`3:4, 10:40-51.
`
`Claim 9 recites a novel pulse oximetry sensor 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
`
`led to improvements in 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
`
`IPR2022-01291
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`-8-
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`
`
`
`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 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 9 also
`
`features additional structures designed to improve signal quality. 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.
`
`IPR2022-01291
`
`-9-
`
`
`
`Based on Al-Ali’s research and the resulting ’745 Patent inventions, Masimo
`
`
`
`
`
`
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`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.
`
`
`
`D. Level of Ordinary Skill in the Art
`
`Apple’s asserted level of ordinary skill in the art is relatively low. Pet., 5-6;
`
`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., 5-6. Masimo submits that
`
`the low level of ordinary skill Apple asserted confirms patentability. Apple’s own
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`engineers with Ph.D.’s and years of experience with pulse oximetry were skeptical
`
`that pulse oximetry could be performed at the wrist, as required by Claims 9 and 18.
`
`IPR2022-01291
`
`-10-
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`
`
`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
`
`light-emitting diodes is projected towards the tissue.”3 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. Id. at ¶¶ 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.
`
`
`3 All emphases are added unless stated otherwise.
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`IPR2022-01291
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`-11-
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`
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`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
`
`“change…into” superfluous and irrelevant. EX2070, ¶ 7. Such a construction is
`
`disfavored. Wasica Finance GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272,
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`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
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`(changing the shape of light into a “wide, donut-shaped area”); EX2002, ¶ 36;
`
`EX2070
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