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)
`Jeremiah S. Helm, Ph.D. (admitted pro hac vice)
`
`
`
`Filed: December 13, 2022
`
`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 PRELIMINARY RESPONSE
`
`
`
`
`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)
`Jeremiah S. Helm, Ph.D. (admitted pro hac vice)
`
`
`
`Filed: December 13, 2022
`
`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 PRELIMINARY RESPONSE
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 4
`
`A. Overview of the Technology ................................................................. 4
`
`B.
`
`C.
`
`The ’745 Patent ..................................................................................... 7
`
`Level of Ordinary Skill in the Art ....................................................... 11
`
`III. CLAIM CONSTRUCTION .......................................................................... 12
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`The Petition Violates 37 C.F.R. § 42.104(b)(3) .................................. 12
`
`The Specification and Prosecution History Drive the
`Proper Construction of “Second Shape” ............................................. 13
`
`Apple Agreed That “a mere difference in size, without
`any other difference, is not a shape different from the
`first shape” ........................................................................................... 16
`
`The Recited “material configured to change the first
`shape into a second shape” Does Not Refer to a Mere
`Diffuser ................................................................................................ 17
`
`Apple Ignores the Dispute Regarding “an array having a
`spatial configuration corresponding to a shape of the
`portion of the tissue measurement site encircled by the
`light block” .......................................................................................... 18
`
`IV. NO GROUND WOULD ESTABLISH OBVIOUSNESS ............................ 20
`
`A. Apple Failed to Address Known Objective Indicia of
`Nonobviousness ................................................................................... 23
`
`-i-
`
`
`
`B.
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`Apple’s Skepticism and Copying of Masimo’s
`Technology Demonstrates the Nonobviousness of
`the Claims ................................................................................. 24
`Apple’s Failures Demonstrate The
`Nonobviousness of the Claimed Material that
`Changes a First Shape to a Second Shape ................................ 29
`Commercial Success ................................................................. 31
`3.
`Nexus......................................................................................... 33
`4.
`Grounds 1A and 1B Based on Iwamiya Fail to
`Demonstrate a Reasonable Likelihood of Success ............................. 34
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`The Examiner Considered a Prior Publication of
`Iwamiya ..................................................................................... 35
`Apple Fails to Demonstrate that a POSITA Would
`Add a “surface comprising a dark-colored coating”
`to Iwamiya (Independent Claims 1 and 20,
`Dependent Claim 14) ................................................................ 35
`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” (Independent Claim 15,
`Dependent Claims 6, 26) ........................................................... 40
`Iwamiya Would Not Be Combined with Sarantos
`to Add a “second wavelength” (Claim 2) ................................. 43
`Apple Fails to Demonstrate “the second shape
`comprises a width and a length, and wherein the
`width is different from the length” (Claim 25) ......................... 46
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`C.
`
`Grounds 2A-2C Based on Sarantos Fail to Demonstrate a
`Reasonable Likelihood of Success ...................................................... 47
`
`1.
`
`2.
`
`3.
`
`Apple Fails to Show a “First Shape” and “Second
`Shape” (Independent Claims 1, 20) .......................................... 47
`Apple Fails to Demonstrate a Motivation to
`Combine Sarantos with Shie with a Reasonable
`Expectation of Success (Independent Claims 1,
`15, and 20) ................................................................................. 49
`Apple Relies on Hindsight to Reconstruct Claims
`12 and 25 ................................................................................... 55
`a)
`Apple Fails to Explain Why a POSITA
`Would Have Used a Cylindrical Lens
`(Claim 25) ....................................................................... 55
`
`b)
`
`Apple Fails to Demonstrate a “Second
`Shape” for Claim 12 ....................................................... 58
`
`5.
`
`4.
`
`Apple Fails to Identify a “light block having a
`circular shape” in the Proposed Combinations
`(Independent Claim 15) ............................................................ 60
`Apple Fails to Demonstrate “wherein the plurality
`of photodiodes are arranged in an array having a
`spatial configuration …” (Independent Claim 15,
`Dependent Claims 6, 26) ........................................................... 62
`RESERVATION OF RIGHTS ...................................................................... 63
`
`V.
`
`VI. CONCLUSION .............................................................................................. 64
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Apple Inc. v. Samsung Elecs. Co., Ltd.,
`839 F.3d 1034 (Fed. Cir. 2016) .......................................................................... 32
`Apple Inc. v. Telefonaktiebolaget LM Ericsson,
`IPR2022-00850, Paper 7 (PTAB Nov. 1, 2022) ................................................. 36
`Arendi S.A.R.L. v. Apple Inc.,
`832 F.3d 1355 (Fed. Cir. 2016) .......................................................................... 41
`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) .......................................................................... 34
`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) .................................................................... 36, 37
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ............................................................................................ 61
`Mallinckrodt, Inc. v. Masimo Corp.,
`147 F. App’x 158, 2005 WL 2139867 (Fed. Cir. Sept. 7, 2005).......................... 1
`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 Electronic N. Am. Corp.,
`2015 WL 2379485 (D. Del. May 18, 2015) ................................................passim
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Masimo Corp. v. True Wearables, Inc.,
`No. 2021-2146, 2022 WL 205485 (Fed. Cir. 2022) ........................................... 26
`Personal Web Techs., LLC v. Apple Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ...................................................................... 49, 57
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 58
`Praxair Distr., Inc. v. Mallinckrodt Hospital Prods.,
`IPR2016-00777, -00778, -00779, -00780 ........................................................... 23
`In re Ratti,
`270 F.2d 810 (CCPA 1959) .......................................................................... 38, 58
`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) .......................................................................... 35
`In re Stepan Co.,
`868 F.3d 1342 (Fed. Cir. 2017) .......................................................................... 62
`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) .......................................................................... 44
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d at 1361-63 ................................................................................ 36, 51, 53
`
`-v-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`OTHER AUTHORITIES
`37 C.F.R. § 42.11 ..................................................................................................... 23
`37 C.F.R. § 42.104 ................................................................................................... 12
`MPEP § 2143.01 ...................................................................................................... 38
`
`
`
`
`-vi-
`
`
`
`IPR2022-01465
`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
`
`
`
`IPR2022-01465
`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
`
`
`
`IPR2022-01465
`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
`
`
`
`IPR2022-01465
`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)
`
`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
`
`
`
`
`
`Exhibit List, Page 4
`
`
`
`IPR2022-01465
`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 September 13, 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. Am. Corp., 2015 WL 2379485 at *1 (D. Del. May 18, 2015).
`
`-1-
`
`
`
`IPR2022-01465
`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”). This Petition does not address any claims
`
`asserted in the Investigation. Instead, Apple filed four staggered petitions on the
`
`’745 Patent and segregated the claims asserted in the Investigation from other
`
`dependent claims. But this Petition largely duplicates the arguments already
`
`presented in IPR2022-01291 against the independent claims. Apple could have
`
`addressed every challenged claim in a single petition, but instead chose to needlessly
`
`multiply the burden on the Board and Masimo.
`
`Moreover, Apple failed to apprise the Board of its prior claim construction
`
`position. During the 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
`
`-2-
`
`
`
`IPR2022-01465
`Apple Inc. v. Masimo Corporation
`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. Nor does it apply that prior claim construction
`
`to the prior art.
`
`Apple also bootstrapped its Petition by alleging that Masimo hid prior art from
`
`the PTO during prosecution of the ’745 Patent. Paper 3, 77, 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. Id. at 77. 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.
`
`During the Investigation evidentiary hearing, Masimo also presented
`
`extensive objective evidence of nonobviousness of the ’745 Patent. That evidence
`
`included testimony from Apple’s top engineers who characterized their work on
`
`developing a pulse oximeter for the wrist as “extremely challenging,” and
`
`“unprecedented.” EX2008, 938:21-24; EX2051, 125. One Apple engineer even
`
`testified that in late 2014, shortly before the ’745 Patent’s effective filing date, his
`
`reaction to receiving the assignment of developing a pulse oximeter for the wrist
`
`was, “good luck with that.” EX2011, 169.
`
`-3-
`
`
`
`IPR2022-01465
`Apple Inc. v. Masimo Corporation
`Apple hid that evidence from the Board. Despite its duty of candor to the
`
`Board, Apple failed to inform the Board that evidence existed, let alone address it.
`
`And when Masimo sought additional evidence redacted from public briefing here,
`
`Apple fought to suppress it. See EX2012; EX2013; EX2014; EX2015; Paper 9.
`
`Apple failed to acknowledge that evidence in the hopes that the Board would
`
`believe that a mere person of ordinary skill could have combined prior art references
`
`to develop a device that measures oxygen saturation from the wrist. See, e.g.,
`
`Pet. 32-33 (arguing the combination of Iwamiya and Sarantos measures blood
`
`oxygen saturation). 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.
`
`II. BACKGROUND
`A. Overview of the Technology
`
`Noninvasive
`
`light-based physiological monitoring devices
`
`rely on
`
`spectroscopy to measure blood constituents, analytes, and/or substances such as
`
`oxygen (oxygen saturation) and other physiological parameters, such as pulse rate
`
`and perfusion index. EX1001, 2:40-50. Using the Beer-Lambert law, the
`
`concentration of an absorbent in a solution can be determined by the intensity of
`
`light transmitted through the solution, knowing the pathlength of the light, the
`
`-4-
`
`
`
`IPR2022-01465
`Apple Inc. v. Masimo Corporation
`intensity of the incident light, and the extinction coefficient of the absorbent at a
`
`particular light wavelength. Id. at 1:31-53.
`
`Pulse oximetry is one type of noninvasive, light-based physiological
`
`monitoring which measures the proportional amount of hemoglobin carrying
`
`oxygen, called arterial oxygen saturation. EX1013, 16, 23; EX2002, ¶ 54. Pulse
`
`oximetry relies on the Beer-Lambert law to measure the concentration of
`
`oxyhemoglobin and hemoglobin. See EX1001, 1:54-2:4. 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.; EX1008, 1:22-40; EX2002 ¶¶ 54-55. 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 ¶ 55. The
`
`detector outputs signals known as photoplethysmography (PPG) signals. Id. The
`
`PPG signal can also be used to determine a user’s pulse rate. Id. 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). EX1001, 1:66-2:4; EX2002, ¶ 55.
`
`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
`
`-5-
`
`
`
`IPR2022-01465
`Apple Inc. v. Masimo Corporation
`caused by patient motion and low perfusion (low blood flow in the tissue
`
`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
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`en banc denied, 147 F. App’x 158 (Fed. Circ. 2005), cert. dismissed, 546 U.S. 1162
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`(2006); Masimo Corp v. Philips Elec. N. Am. Corp., No. 1:09-cv-00080, 2015 WL
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`2379485, at *19 (D. Del. May 18, 2015).
`
`Masimo has continued to develop numerous breakthroughs in the field of
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`noninvasive physiological monitoring, including the industry’s first noninvasive
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`methemoglobin measurement (SpMet®), the first pleth variability index (PVI), the
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`Apple Inc. v. Masimo Corporation
`first noninvasive and continuous total hemoglobin measurement (SpHb®), and the
`
`first noninvasive fractional oxygen saturation measurement (SpfO2®), among others.
`
`See EX2066 at 4-9.
`
`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
`
`obscured by noise. EX1001, 7:4-62, 8:54-9:10, 10:40-11:66, Figs. 7A-7B. Those
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`enhancements improve noninvasive physiological measurements including blood
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`oxygen saturation, pulse rate, perfusion index, and others during more difficult
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`conditions and from more difficult sites like the wrist. Id. at 1:23-27, 2:40-3:4,
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`10:40-51. The improvements expanded the already-revolutionary technology
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`Masimo brought to the industry in the 1990s.
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`Before the ’745 Patent, the conventional approach to pulse oximetry applied
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`a two-dimensional analytical model to the three-dimensional space of the tissue
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`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
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`variable in the Beer-Lambert law, which would lead to more accurate physiological
`
`measurements. Id. at 5:66-6:1; EX2002, ¶ 59.
`
`Around 2014 or 2015, the inventor of the ’745 Patent, Ammar Al-Ali,
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`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
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`study found that the difference between the average pathlengths for red and infrared
`
`light affects the calibration curve for a pulse oximeter, thereby decreasing accuracy.
`
`Id. In contrast to the conventional two-dimensional approach, Al-Ali applied a
`
`three-dimensional analytical model to the three-dimensional tissue being measured,
`
`leading to a more accurate oxygen saturation measurement. Id. at 6:55-7:3. Rather
`
`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
`
`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
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`Apple Inc. v. Masimo Corporation
`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
`
`tissue. Id. at 7:40-62, 10:65-11:9. As explained by Al-Ali, increased light
`
`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.
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`The combination of features in the ’745 Patent work together to increase the
`
`signal-to-noise ratio, which improves the accuracy of physiological measurements,
`
`including oxygen saturation and pulse rate, among others. See EX1001, 2:40-50.
`
`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 the user’s tissue and the sensor, leading to considerably
`
`longer photon pathlengths that affect the accuracy of the measurement. Id. at 8:54-
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`9:7; EX2002, ¶ 62.
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`The ’745 Patent also teaches measuring physiological parameters, such as
`
`blood oxygen, from the wrist in a reflectance arrangement. EX1001, 10:40-51, Figs.
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`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 and pulse
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`rate, at the user’s wrist.
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`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
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`oximeter, culminating in what is now sold as the Masimo W1™ watch. EX2008,
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`248:24-250:14.
`
`
`
`C. Level of Ordinary Skill in the Art
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`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. 4-5; 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.
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`Apple Inc. v. Masimo Corporation
`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:
`
`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
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`the claims should be construed under the Phillips standard, it offers no construction
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`under that standard. Pet. 5. 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.
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`At least “second shape” needs to be construed to resolve the patentability
`
`controversy. Apple agreed during the Investigation that “a mere difference in size
`
`is neither necessary nor sufficient to change a first shape into a ‘second shape.’”
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`EX2053, 3 n.1. Apple relied on that construction to address validity and
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`infringement. See, e.g., EX2050, 162 (Apple
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