Filed: November 4, 2022
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`By: Brian C. Claassen (Reg. No. 63,051)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Jarom D. Kesler (Reg. No. 57,046)
`Jacob L. Peterson (Reg. No. 65,096)
`Daniel Kiang (Reg. No. 79,631)
`
`
`
`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 PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`By: Brian C. Claassen (Reg. No. 63,051)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Jarom D. Kesler (Reg. No. 57,046)
`Jacob L. Peterson (Reg. No. 65,096)
`Daniel Kiang (Reg. No. 79,631)
`
`
`
`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 PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 4
`
`A. Overview of the Technology ................................................................. 4
`
`B.
`
`C.
`
`The ’745 Patent ..................................................................................... 5
`
`Level of Ordinary Skill in the Art ....................................................... 10
`
`III. CLAIM CONSTRUCTION .......................................................................... 10
`
`A.
`
`B.
`
`C.
`
`The Petition Violates 37 C.F.R. § 42.104(b)(3) .................................. 10
`
`The Specification and Prosecution History Drive the
`Proper Construction of “Second Shape” ............................................. 12
`
`Apple Agreed That “a mere difference in size, without
`any other difference, is not a shape different from the
`first shape” ........................................................................................... 15
`
`D. Apple Improperly Limits “material configured to
`change the first shape into a second shape” to a
`Diffuser ................................................................................................ 16
`
`E.
`
`Apple Ignores the Claim Construction Dispute
`Regarding “plurality of photodiodes are 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” ......................................................... 17
`
`IV. NO GROUND WOULD ESTABLISH OBVIOUSNESS ............................ 20
`
`A. Apple Failed to Address Known Objective Indicia of
`Nonobviousness ................................................................................... 22
`
`-i-
`
`
`
`B.
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`Apple’s Skepticism and Copying of Masimo’s
`Technology Demonstrates the Nonobviousness
`of Oxygen Saturation Measurements at the
`Wrist (Claims 9 and 18) ............................................................ 24
`Apple’s Failures Demonstrate The
`Nonobviousness of Claimed Material that
`Changes a First Shape to a Second Shape ................................ 27
`Commercial Success ................................................................. 30
`3.
`Nexus......................................................................................... 32
`4.
`Grounds 1A and 1B Based on Iwamiya Fail to
`Demonstrate a Reasonable Likelihood of Success ............................. 33
`
`1.
`
`2.
`
`The Examiner Considered a Prior Publication
`of Iwamiya ................................................................................ 34
`Apple Fails to Demonstrate that Claims 9 and
`18, which Require Measuring Oxygen
`Saturation at the Wrist Would Have Been
`Obvious ..................................................................................... 34
`a)
`Iwamiya Does Not Disclose Oxygen
`Saturation ........................................................................ 35
`
`b)
`
`c)
`
`Apple Fails to Explain Why a POSITA
`Would Have Combined Iwamiya with
`Sarantos ........................................................................... 37
`
`A POSITA Would Not Have Expected
`Success in the Combination ............................................ 39
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`3.
`
`4.
`
`Iwamiya Would Not Be Combined with
`Sarantos to Add a “second wavelength” (Claim
`27) ............................................................................................. 42
`Apple Fails to Demonstrate that a POSITA
`Would Add a “surface comprising a dark-
`colored coating” to Iwamiya (Claims 1, 9, 20,
`27) ............................................................................................. 43
`Apple Fails to Demonstrate 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) ........................... 47
`Grounds 2A and 2B Based on Sarantos Fail to
`Demonstrate a Reasonable Likelihood of Success ............................. 48
`
`5.
`
`C.
`
`1.
`
`2.
`
`3.
`
`4.
`
`Apple Fails to Show a “First Shape” and
`“Second Shape” (Claims 1, 9, 20, 27) ...................................... 49
`Apple Fails to Demonstrate a Motivation to
`Combine Sarantos with Shie with a Reasonable
`Expectation of Success (Claims 1, 9, 15, 18, 20,
`27) ............................................................................................. 51
`Apple Fails to Show that Measuring Oxygen
`Saturation at the Wrist Would Have Been
`Obvious (Claims 9, 18) ............................................................. 56
`Apple Fails to Identify a “light block having a
`circular shape” in the Proposed Combinations
`(Claims 15, 18) .......................................................................... 56
`
`-iii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`5.
`
`Apple Does Not Address “wherein the plurality
`of photodiodes are arranged in an array having
`a spatial configuration …” (Claims 15, 18) .............................. 58
`RESERVATION OF RIGHTS ...................................................................... 59
`
`V.
`
`VI. CONCLUSION .............................................................................................. 59
`
`
`
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple Inc. v. Samsung Elecs. Co., Ltd.,
`839 F.3d 1034 (Fed. Cir. 2016) .......................................................................... 30
`Apple Inc. v. Telefonaktiebolaget LM Ericsson,
`IPR2022-00850, Paper 7 (PTAB Nov. 1, 2022) ................................................. 44
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche, Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ............................................. 23
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366 (Fed. Cir. 2019) .......................................................................... 32
`Gilead Sciences, Inc. v. United States,
`IPR2019-01456, Paper 17 (PTAB Feb. 5, 2020) ................................................ 23
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .................................................................... 43, 45
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................ 57
`Mallinckrodt, Inc. v. Masimo Corp.,
`147 F. App’x 158, 2005 WL 2139867 (Fed. Cir. Sept. 7, 2005)...................... 1, 5
`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 .................................................................... 5
`Masimo Corp. v. Philips Electronic N, Amer. Corp.,
`2015 WL 2379485 (D. Del. May 18, 2015) ................................................passim
`Masimo Corp. v. True Wearables, Inc.,
`No. 2021-2146, 2022 WL 205485 (Fed. Cir. 2022) ........................................... 25
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ...................................................................... 40, 51
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Praxair Distr., Inc. v. Mallinckrodt Hospital Prods.,
`IPR2016-00777, -00778, -00779, -00780 ........................................................... 23
`In re Ratti,
`270 F.2d 810 (CCPA 1959) ................................................................................ 45
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01751, Paper No. 15 (PTAB Mar. 22, 2017) ...................................... 23
`Semiconductor Components Indus., LLC v. Power Integrations, Inc.,
`IPR2016-01588, Paper 15 (PTAB Feb. 17, 2017) .............................................. 23
`Shire LLC v. Amneal Pharm., LLC,
`802 F.3d 1301 (Fed. Cir. 2015) .......................................................................... 34
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) .......................................................................... 57
`Stryker Corp. v. KFX Medical, LLC,
`IPR2019-00817, paper 10 (PTAB Sept. 16, 2019) ............................................. 23
`Tec Air, Inc. v. Denso Mfg. Michigan Inc.,
`192 F.3d 1353 (Fed. Cir. 1999) .......................................................................... 39
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d at 1361-63 ...................................................................................... 43, 53
`OTHER AUTHORITIES
`37 C.F.R. § 42.11 ..................................................................................................... 22
`37 C.F.R. § 42.104 ................................................................................................... 10
`MPEP § 2143.01 ...................................................................................................... 45
`
`
`
`-vi-
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`
`
`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
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`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, 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
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`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
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`Exhibit
`No.
`
`Description
`
`2064
`
`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)
`
`
`
`
`
`Exhibit List, Page 4
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`
`
`
`Pursuant to 35 U.S.C. § 313, 37 C.F.R. § 42.107 and the Notice of Filing Date
`
`Accorded to Petition, dated August 4, 2022 (see Paper 4), Masimo Corporation
`
`(“Masimo”) hereby timely submits its Preliminary Response to the Petition for Inter
`
`Partes Review of U.S. Patent No. U.S. Patent 10,687,745 (“’745 Patent”) filed by
`
`Apple Inc. (“Apple” or “Petitioner”).
`
`I. INTRODUCTION
`
`Masimo is the technology leader in the field of noninvasive physiological
`
`monitoring. In 1989, Masimo was a small startup run out of an inventor’s condo.
`
`Today, Masimo is a publicly traded company that employs 6,300 people worldwide
`
`and has annual revenues exceeding one billion dollars. Masimo technology is used
`
`in clinical care to monitor over 200 million patients a year. This growth followed
`
`Masimo’s development of a range of technologies that revolutionized the field of
`
`noninvasive physiological monitoring. Other Masimo patents have withstood
`
`extensive attacks, including in litigation through trial, inter partes review, and
`
`appeal.1
`
`Apple’s Petition arises from a dispute with Masimo in the International Trade
`
`Commission. Apple was not, historically, a company that had any involvement in
`
`
`1 See Mallinckrodt, Inc. v. Masimo Corp., 147 F. App’x 158, 2005 WL 2139867 at
`*3 (Fed. Cir. Sept. 7, 2005) (nonprecedential); Masimo Corp. v. Philips Electronic
`N, Amer. Corp., 2015 WL 2379485 at *1 (D. Del. May 18, 2015).
`
`-1-
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`physiological monitoring devices. But, around 2013, Apple decided to enter the
`
`field and sought out Masimo for that technology. Although claiming an interest to
`
`integrate Masimo’s technology into Apple products, Apple began poaching
`
`employees, one after another. The poached employees included Chief Technical
`
`Officer Marcelo Lamego. Lamego took Masimo’s pulse oximetry, including sensor
`
`design, knowledge with him to Apple. Masimo has accused Apple’s devices of
`
`using Masimo technology, including key features disclosed and claimed in the ’745
`
`Patent.
`
`Masimo asserted the ’745 Patent against Apple in an ITC proceeding—Inv.
`
`No. 337-TA-1276 (the “Investigation”). During that Investigation, Apple relied on
`
`an agreed upon claim construction to argue noninfringement of the ’745 Patent.
`
`Specifically, independent Claims 1 and 20 require a material that changes a “first
`
`shape” of light into a “second shape.” Apple agreed that, based on clear prosecution
`
`history, a change in size is not a change in shape. Now, in an about-face, Apple does
`
`not even mention that agreement or the prosecution history.
`
`During the Investigation evidentiary hearing, Apple promised the ALJ it
`
`would “present the best possible evidence” for its ’745 Patent invalidity arguments.
`
`See EX2008, 39:11-17. In response, Masimo presented extensive objective evidence
`
`of nonobviousness of the ’745 Patent. Now, Apple seeks a second bite at invalidity
`
`by presenting the same arguments it used in the Investigation.
`
`-2-
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`Apple bootstrapped its Petition by alleging that Masimo hid prior art from the
`
`PTO during prosecution of the ’745 Patent. Paper 2, 46, see also id. at 3-4. Apple’s
`
`allegations were demonstrably false. Apple based those allegations on IPRs that it
`
`had filed after the ’745 Patent had already issued. Paper 2, 46. Masimo fully
`
`complied with its duty of candor to the PTO by disclosing the art Masimo knew of
`
`during prosecution. Apple had no excuse for levying its allegations and withdrew
`
`them in the Corrected Petition. See EX2058.
`
`Apple projects its own litigation strategy on Masimo. While accusing
`
`Masimo of hiding evidence, Apple hid evidence from the Board. Masimo presented
`
`evidence from Apple demonstrating nonobviousness during the Investigation.
`
`EX2011, 158-175, 233-234. Yet, despite its duty of candor to the Board, Apple’s
`
`Petition failed to inform the Board that evidence existed, let alone address it. And
`
`when Masimo sought to present that evidence here, Apple fought to suppress it. See
`
`EX2012; EX2013; EX2014; EX2015; Paper 9.
`
`
`
`Apple should have addressed that evidence head-on. Its failure to do so, and
`
`its failure to inform the Board of how the claims should be construed, render the
`
`Petition deficient. The Board should deny institution.
`
`-3-
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`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 measurement of the concentration of oxyhemoglobin and hemoglobin in blood
`
`to be measured by measuring the absorption of light at known wavelengths and a
`
`known light pathlength. See EX1001, 1:66-2:4. Pulse oximeters include at least
`
`two light sources, typically light-emitting diodes (LEDs), that transmit red and
`
`infrared light into an individual’s tissue, and a light detector, typically a
`
`photodiode. Id. Some of the transmitted light is absorbed by the tissue and pulsating
`
`blood flow. Id. The detector measures the light from both wavelengths after it has
`
`passed through the tissue. Id. at 16-17. The ratio of light detected at the red
`
`wavelength compared to light detected at the infrared wavelength indicates the
`
`amount of hemoglobin carrying oxygen. That is known as oxygen saturation
`
`(SpO2). Id.; see also EX2002, ¶¶ 53-54.
`
`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 tissue
`
`-4-
`
`
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`measurement 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, 92:29-94:17, 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 very 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).
`
`B.
`
`The ’745 Patent
`
`Masimo’s research and development to further improve non-invasive
`
`measurement accuracy led to the ’745 Patent, originally filed in 2015. The ’745
`
`Patent sets forth various enhancements to improve the signals that are typically
`
`-5-
`
`
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`obscured by noise. EX1001, 7:4-62, 8:54-9:10, 10:40-11:66, Figs. 7A-7B. Those
`
`enhancements improve measurement during more difficult conditions and from
`
`more difficult sites like the wrist. Id. at 1:23-27, 2:40-3:4, 10:40-51. The
`
`improvements expanded the already-revolutionary technology Masimo brought to
`
`the industry in the 1990s.
`
`Before the ’745 Patent, the conventional approach to pulse oximetry applied
`
`a two-dimensional analytical model to the three-dimensional space of the tissue
`
`measurement site. Id. at 5:41-50. In this 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 at the time 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 oximetry
`
`measurements. Id.; EX2002, ¶ 59.
`
`Around 2014 or 2015, the inventor of the ’745 Patent, Ammar Al-Ali,
`
`researched pulse oximetry on the wrist. EX2008, 248:24-249:8. Al-Ali sought to
`
`improve the measurement by maximizing the amount of light that interacted with
`
`the tissue while minimizing the light that did not interact with the tissue as intended.
`
`EX2011, 20. Al-Ali recognized that light does not actually travel in straight paths
`
`through tissue due to “multiple scattering” within the tissue. EX1001, 6:1-20. A
`
`-6-
`
`
`
`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`study found that the difference between the average pathlengths for red and infrared
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`light affects the calibration curve for a pulse oximeter, thereby decreasing accuracy.
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`Id. In contrast to the conventional two-dimensional approach, Al-Ali applied a
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`three-dimensional analytical model to the three-dimensional tissue being measured,
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`leading to a more accurate oxygen saturation measurement. Id. at 6:55-7:3. Rather
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`than irradiating tissue with a simple point source, Al-Ali departed from the
`
`conventional wisdom 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 6:21-54; see
`
`also EX2002, ¶¶ 60-61.
`
`The ’745 Patent explains many sources of measurement error in pulse
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`oximetry systems, one of those being the way light scatters as the photons pass
`
`through the patient’s tissue. EX1001, 2:28-37. This problem results from traditional
`
`pulse oximetry where the light is emitted from LED point sources. Id. at 5:41-50.
`
`The ’745 Patent explains that this approach of irradiating with an optical point source
`
`was believed to reduce variability. But Al-Ali found that “multiple scattering,”
`
`where light pathlengths vary due to light bouncing around various irregular objects
`
`like blood cells, inhibited such a reduction. Id. at 5:65-6:20.
`
`The ’745 Patent discloses innovations to improve accuracy “by irradiating a
`
`larger volume of tissue.” EX1001, 6:58-64. One way to accomplish this is to use
`
`optical transmission materials configured to increase the light interaction with the
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`-7-
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`tissue. Id. at 7:40-62, 10:65-11:9. As explained by Al-Ali, increased light
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`interaction led to more accurate oxygen saturation measurements. Id. at 6:64-7:3.
`
`The innovations also include specific configurations to decrease light piping. Id. at
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`8:54-9:10; 7:16-29. Light piping occurs when light from the LEDs reaches the
`
`detectors without passing through the tissue. Id. at 7:25-29. The patent describes
`
`light blocks to inhibit LED light from reaching the detectors before attenuation by
`
`the tissue. Id. at 10:49-51, 11:10-20, Figs. 7A-7B; EX2002, ¶ 62.
`
`The innovation also involves optical materials to distribute the light from the
`
`LEDs, preferably in a manner to change the shape of light to improve the interaction
`
`with the relevant tissue. See, e.g., EX1001, 3:5-14, 4:16-28, 6:58-7:3, 7:40-62, 7:63-
`
`8:19, 10:65-11:9. The patent discloses one option of using “microlens-based”
`
`engineered diffusers to deliver efficient illumination. Id. at 3:5-8.
`
`The combination of features in the ’745 Patent work together to increase the
`
`signal-to-noise ratio, which improves the accuracy of measurements. For example,
`
`the ’745 Patent explains that by irradiating a larger volume of tissue, a larger sample
`
`size of light attenuated by the tissue is measured, which is “more representative of
`
`the complete interaction of the emitted light as it passes through the patient’s blood
`
`as compared to the 2D point source approach” in the prior art. Id. at 6:55-7:3. The
`
`patent also explains that the use of a dark-colored coating can also address another
`
`multiple-scattering problem where emitted light can reflect back and forth between
`
`-8-
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`the user’s tissue and the sensor, leading to considerably longer photon pathlengths
`
`that affect the accuracy of the measurement. Id. at 8:54-9:7; EX2002, ¶ 62.
`
`The ’745 Patent also teaches measuring a user’s blood oxygen from the wrist
`
`in a reflectance arrangement. EX1001, 10:40-51, Figs. 7A-7B. By shaping the light
`
`interaction with the tissue and the detector, Al-Ali provided a more accurate design
`
`with a better signal-to-noise ratio. Id. The claimed inventions of the ’745 Patent
`
`provide novel combinations of these features allowing improved measurement of a
`
`user’s physiological parameters, such as SpO2, at the user’s wrist.
`
`Based on Al-Ali’s research and the resulting ’745 Patent inventions, Masimo
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`began pursuing the development of a commercial medical-grade wrist-based pulse
`
`oximeter, culminating in what is now sold as the Masimo W1™ watch. EX2008,
`
`248:24-250:14.
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`-9-
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`
`
`
`C. Level of Ordinary Skill in the Art
`
`Apple’s asserted level of skill requires no coursework, training, or experience
`
`with optics, optical physiological sensors, or physiology, and focuses on data
`
`processing rather than sensor design. Pet. 5-6; EX2002, ¶¶ 29-32. Apple does not
`
`contend that the level of skill in the art affects the patentability of the challenged
`
`claims. Id. However, Masimo submits that Apple’s asserted level of skill confirms
`
`patentability, as explained below.
`
`III. CLAIM CONSTRUCTION
`A. The Petition Violates 37 C.F.R. § 42.104(b)(3)
`
`37 C.F.R. § 42.104(b)(3) requires the Petition to identify “[h]ow the
`
`challenged claim is to be construed.” The Trial Practice Guide further explains:
`
`-10-
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`If a petitioner believes that a claim term requires an express
`construction, the petitioner must include a statement identifying a
`proposed construction of the particular term and where the intrinsic
`and/or extrinsic evidence supports that meaning.
`
`Consolidated Trial Practice Guide (Nov. 2019), 44.
`
`Apple’s Petition does not meet this requirement. While Apple acknowledges
`
`the claims should be construed under the Phillips standard, it offers no construction
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`under that standard. Pet. 6. Instead, Apple “submits that no claim terms need be
`
`construed to resolve issues of controversy in the present Petition.” Id. The Board
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`should reject that excuse.
`
`At least “second shape” needs to be construed to resolve the patentability
`
`controversy. During the Investigation, Apple relied on a particular construction of
`
`“second shape” in Claims 1 and 20 to address validity and infringement. See, e.g.,
`
`EX2050, 162 (Apple arguing noninfringement because “there is no change in shape
`
`at all caused by [the material] only a change in size, which the parties agree is not
`
`sufficient to meet the claims.”) (original emphasis); id. at 187 (arguing the Iwamiya
`
`reference taught a second shape). Apple ultimately agreed that “a mere difference
`
`in size is neither necessary nor sufficient to change a first shape into a ‘second
`
`shape.’” EX2053, 3 n.1. Apple relied on that construction to argue noninfringement.
`
`After relying on a construction to contest infringement, Apple cannot now avoid that
`
`construction for patentability. Apple’s invalidity arguments here fail to address that
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`-11-
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`
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`prior agreed construction or explain how its asserted references disclose a “second
`
`shape” as properly construed. For example, as discussed below, Apple fails to
`
`explain how its proposed combination of Sarantos and Shie would result in a change
`
`from a “first shape” of light to a “second shape.” Therefore, the Petition should be
`
`denied because Apple failed to identify “[h]ow the challenged claim is to be
`
`construed.”
`
`B.
`
`The Specification and Prosecution History Drive the Proper
`Construction of “Second Shape”
`
`Both the intrinsic record and the parties’ positions during the Investigation
`
`confirm that “second shape” in Claims 1 and 20 means “a shape that is different than
`
`the first shape, except that a mere difference in size is neither necessary nor sufficient
`
`to change a first shape into a second shape.”
`
`Masimo and Apple briefed the proper construction of “second shape” during
`
`the Investigation. See EX2054, 21-24. The parties agreed that the specification
`
`describes the “shape” of light according to the ordinary meaning of shape, describing
`
`rectangles, squares, circles, and donuts. See, e.g., EX1001, 3:8-14, 8:9-12, 10:65-
`
`11:2, Figs. 3, 7A, 7B; EX2052, 142; EX2054, 22. For example, the specification
`
`explains that in Figure 7A a “light diffuser 704 receives the optical radiation emitted
`
`from the emitter 702 and homogenously spreads the optical radiation over a wide,
`
`donut-shaped area.” EX1001, 10:65-11:2; see also EX2002, ¶¶ 35-36.
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`-12-
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`IPR2022-01291
`Apple Inc. v. Masimo Corporation
`Claims 1 and 20 use the term “shape” consistent with the specification. Both
`
`claims recite “a plurality of light-emitting diodes configured to emit light in a first
`
`shape” and 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.” Thus, the claims require a “first shape” emitted from
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`the LEDs, and a different “second shape” after the light from the LED has interacted
`
`with the claimed “material.” EX2002, ¶ 37.
`
`The prosecution history of a parent application also explains when a “second
`
`shape” is different than a “first shape.” Specifically, during prosecution of U.S. Pat.
`
`App. No. 16/532,065 (“the ’065 Application”), Masimo added then-pending claim 2
`
`that recited: “a material positioned between the plurality of emitters and the
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