`
`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:
`AppleIPR745-2@knobbe.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2022-01292
`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 ..................................................................................... 6
`
`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 ................................................................................................ 17
`
`IV. NO GROUND WOULD ESTABLISH OBVIOUSNESS ............................ 17
`
`A. Apple Failed to Address Known Objective Indicia of
`Nonobviousness ................................................................................... 19
`
`1.
`
`Apple’s Skepticism and Copying of Masimo’s
`Technology Demonstrates the Nonobviousness
`of Oxygen Saturation Measurements at the
`Wrist (Claims 9 and 18) ............................................................ 21
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`2.
`
`3.
`
`4.
`
`Apple’s Failures Demonstrate the
`Nonobviousness of Claimed Material that
`Changes a First Shape to a Second Shape ................................ 25
`
`Commercial Success ................................................................. 27
`
`Nexus......................................................................................... 29
`
`B.
`
`Grounds 1A and 1B Based on Ackermans Fail to
`Show that Any Claim Would Have Been Obvious ............................. 30
`
`1.
`
`2.
`
`3.
`
`4.
`
`Apple Fails to Show a “First Shape” and
`“Second Shape” (Claims 1, 9, 20, 27) ...................................... 31
`
`Apple Fails to Demonstrate that a POSITA
`Would Have Been Motivated to Combine
`Ackermans and Savant with a Reasonable
`Expectation of Success (Claims 1, 9, 15, 18, 20,
`27) ............................................................................................. 32
`
`Apple Relied on Hindsight to Argue a POSITA
`Would Have Used a Plurality of Photodiodes in
`Ackermans (Claims 1, 9, 15, 18, 20, 27) .................................. 37
`
`Apple Fails to Identify a “surface comprising a
`dark-colored coating” as Claimed (Claims 1, 9,
`20, 27) ....................................................................................... 38
`
`a)
`
`b)
`
`Apple Fails to Identify Any Dark-
`Colored Coating .............................................................. 39
`
`Ackermans’ Adhesive Is Not “positioned
`between the plurality of photodiodes and
`the tissue when the physiological
`monitoring device is in use” ........................................... 40
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`c)
`
`There Is No “opening defined in the
`dark-colored coating” as Claimed .................................. 41
`
`C.
`
`Ground 2A Based on Mendelson-799 Fail to Show
`that Any Claim Would Have Been Obvious ....................................... 42
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`The Examiner Already Considered a PCT
`Publication of Mendelson-799 and a Parent of
`Venkatraman ............................................................................. 42
`
`Apple Fails to Identify a “First Shape” and
`“Second Shape” in the Proposed Combination
`(Claims 1, 9, 20, 27) .................................................................. 43
`
`A POSITA Would Not Have Been Motivated to
`Combine Mendelson-799 and Savant with a
`Reasonable Expectation of Success (Claims 1,
`9, 15, 18, 20, 27) ....................................................................... 44
`
`A POSITA Would Not Have Had a Reasonable
`Expectation of Success in Modifying
`Mendelson-799 in view of Venkatraman to
`Measure Oxygen Saturation at the Wrist
`(Claims 1, 9, 15, 18, 20, 27) ...................................................... 48
`
`A POSITA Would Not Have Been Motivated to
`Combine Mendelson-799 with a Black Mask
`from Haar (Claims 1, 9, 20, 27) ................................................ 50
`
`V.
`
`RESERVATION OF RIGHTS ...................................................................... 53
`
`VI. CONCLUSION .............................................................................................. 54
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`ActiveVideo Networks v. Verizon Comms.,
`694 F.3d 1312 (Fed. Cir. 2012) .................................................................... 37, 47
`Adidas AG v. Nike, Inc.,
`963 F.3d 1355 (Fed. Cir. 2020), cert denied, 141 S. Ct. 1376
`(2021) .................................................................................................................. 39
`Apple Inc. v. Samsung Elecs. Co., Ltd.,
`839 F.3d 1034 (Fed. Cir. 2016) .......................................................................... 28
`Apple Inc. v. Telefonaktiebolaget LM Ericsson,
`IPR2022-00850, Paper 7 (PTAB Nov. 1, 2022) ................................................. 35
`Coalition for Affordable Drugs V LLC v. Hoffman-LaRoche, Inc.,
`IPR2015-01792, Paper 14 (PTAB Mar. 11, 2016) ............................................. 20
`In re Dow Chem. Co.,
`837 F.2d 469 (Fed. Cir. 1988) ............................................................................ 38
`Fox Factory, Inc. v. SRAM, LLC,
`994 F.3d 1366 (Fed. Cir. 2019) .......................................................................... 30
`Gilead Sciences, Inc. v. United States,
`IPR2019-01456, Paper 17 (PTAB Feb. 5, 2020) ................................................ 20
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 53
`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
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Masimo Corp. v. True Wearables, Inc.,
`No. 2021-2146, 2022 WL 205485 (Fed. Cir. 2022) ........................................... 22
`Personal Web Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ............................................................................ 52
`Praxair Distr., Inc. v. Mallinckrodt Hospital Prods.,
`IPR2016-00777, -00778, -00779, -00780 ........................................................... 20
`Robert Bosch Tool Corp. v. SD3, LLC,
`IPR2016-01751, Paper No. 15 (PTAB Mar. 22, 2017) ...................................... 20
`Semiconductor Components Indus., LLC v. Power Integrations, Inc.,
`IPR2016-01588, Paper 15 (PTAB Feb. 17, 2017) .............................................. 20
`Shire LLC v. Amneal Pharm., LLC,
`802 F.3d 1301 (Fed. Cir. 2015) .......................................................................... 43
`Stryker Corp. v. KFX Medical, LLC,
`IPR2019-00817, paper 10 (PTAB Sept. 16, 2019) ............................................. 20
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d 1352 (Fed. Cir. 2019) .................................................................... 36, 45
`OTHER AUTHORITIES
`37 C.F.R. § 42.11 ..................................................................................................... 20
`37 C.F.R. § 42.104 ............................................................................................. 10, 32
`
`
`-v-
`
`
`
`IPR2022-01292
`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
`
`
`
`IPR2022-01292
`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
`
`
`
`IPR2022-01292
`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
`
`
`
`IPR2022-01292
`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
`
`
`
`IPR2022-01292
`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 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
`
`physiological monitoring devices. But, around 2013, Apple decided to enter the
`
`
`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-
`
`
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`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. 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. Apple also does not identify a
`
`“first shape” or “second shape” in its analysis of the claims, much less explain how
`
`they are different. Apple asks the Board to apply “second shape” in a manner
`
`inconsistent with its prior agreement and litigation positions, and inconsistent with
`
`the clear prosecution history.
`
`During the Investigation evidentiary hearing, Apple promised the ALJ it
`
`would “present the best possible evidence” for its ’745 Patent invalidity arguments.
`
`-2-
`
`
`
`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`See EX2008, 39:11-17. Apple did not even present Ackermans or Mendelson-799
`
`as prior art in their invalidity case. Apparently, Apple concluded that Ackermans
`
`and Mendelson-799 were not the “best possible evidence.” Now, Apple seeks a
`
`second bite at invalidity.
`
`Apple bootstrapped its Petition by alleging that “Masimo failed to cite the
`
`Ackermans, Venkatraman, and Mendelson-799 references” despite knowing about
`
`them based on IPRS Apple filed against another patent. Paper 3, 77-78 (citing
`
`IPR2020-01722, -01723); see also id. at 3-4. Apple’s allegations were a fictional
`
`narrative. Apple filed its those IPRs after the ’745 Patent had issued. During
`
`prosecution of the ’745 Patent, Masimo had submitted the PCT publication of
`
`Mendelson-799. EX1001, References Cited (citing WO 02/28274). Masimo did not
`
`know of Ackermans or Venkatraman during prosecution. Thus, Masimo fully
`
`complied with its duty of candor to the PTO. Apple apparently recognized the
`
`frivolousness of its false narrative and withdrew those allegations in the Corrected
`
`Petition. EX2058.
`
`Apple projects its own litigation conduct on Masimo. While accusing
`
`Masimo of hiding evidence, Apple is actively hiding evidence from the Board.
`
`Masimo presented substantial evidence from Apple demonstrating nonobviousness
`
`during the Investigation. EX2011, 158-175, 233-234. Yet, despite its duty of
`
`candor, Apple failed to inform the PTAB of even the existence of such evidence,
`
`-3-
`
`
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`much less address it in the Petition. 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 its prior inconsistent claim construction position,
`
`render the Petition deficient. The Board should deny institution.
`
`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
`
`-4-
`
`
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`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
`
`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 pulse oximetry 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
`
`-5-
`
`
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`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
`
`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.
`
`-6-
`
`
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`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
`
`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
`
`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
`
`-7-
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`was believed to reduce variability. But Al-Ali found that “multiple scattering,”
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`where light pathlengths vary due to light bouncing around various irregular objects
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`like blood cells, inhibited such a reduction. Id. at 5:65-6:20.
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`The ’745 Patent discloses innovations to improve accuracy “by irradiating a
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`larger volume of tissue.” EX1001, 6:58-64. One way to accomplish this is to use
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`optical transmission materials configured to increase the light interaction with the
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`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.
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`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
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`detectors without passing through the tissue. Id. at 7:25-29. The patent describes
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`light blocks to inhibit LED light from reaching the detectors before attenuation by
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`the tissue. Id. at 10:49-51, 11:10-20, Figs. 7A-7B; EX2002, ¶ 62.
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`The innovation also involves optical materials to distribute the light from the
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`LEDs, preferably in a manner to change the shape of light to improve the interaction
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`with the relevant tissue. See, e.g., EX1001, 3:5-14, 4:16-28, 6:58-7:3, 7:40-62, 7:63-
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`8:19, 10:65-11:9. The patent discloses one option of using “microlens-based”
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`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
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`signal-to-noise ratio, which improves the accuracy of measurements. For example,
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`the ’745 Patent explains that by irradiating a larger volume of tissue, a larger sample
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`size of light attenuated by the tissue is measured, which is “more representative of
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`the complete interaction of the emitted light as it passes through the patient’s blood
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`as compared to the 2D point source approach” in the prior art. Id. at 6:55-7:3. The
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`patent also explains that the use of a dark-colored coating can also address another
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`multiple-scattering problem where emitted light can reflect back and forth between
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`the user’s tissue and the sensor, leading to considerably longer photon pathlengths
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`that affect the accuracy of the measurement. Id. at 8:54-9:7; EX2002, ¶ 62.
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`The ’745 Patent also teaches measuring a user’s blood oxygen from the wrist
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`in a reflectance arrangement. EX1001, 10:40-51, Figs. 7A-7B. By shaping the light
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`interaction with the tissue and the detector, Al-Ali provided a more accurate design
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`with a better signal-to-noise ratio. Id. The claimed inventions of the ’745 Patent
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`provide novel combinations of these features allowing improved measurement of a
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`user’s physiological parameters, such as SpO2, 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.
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
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`C. Level of Ordinary Skill in the Art
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`Apple’s asserted level of skill requires no coursework, training, or experience
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`with optics, optical physiological sensors, or physiology, and focuses on data
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`processing rather than sensor design. Pet. 5-6; EX2002, ¶¶ 29-32. Apple does not
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`contend that the level of skill in the art affects the patentability of the challenged
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`claims. Id. However, Masimo submits that Apple’s asserted level of skill confirms
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`patentability, as explained below.
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`III. CLAIM CONSTRUCTION
`A. The Petition Violates 37 C.F.R. § 42.104(b)(3)
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`37 C.F.R. § 42.104(b)(3) requires the Petition to identify “[h]ow the
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`challenged claim is to be construed.” The Trial Practice Guide further explains:
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`IPR2022-01292
`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.
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`Consolidated Trial Practice Guide (Nov. 2019), 44.
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`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. 6. Instead, Apple argues that “no formal claim
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`constructions are necessary in this proceeding because ‘claim terms need only be
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`construed to the extent necessary to resolve the controversy.’” Id. (citation omitted).
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`The Board should reject that excuse.
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`At least “second shape” needs to be construed to resolve the patentability
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`controversy. During the Investigation, Apple relied on a particular construction of
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`“second shape” in Claims 1 and 20 to address validity and infringement. See, e.g.,
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`EX2050, 162 (Apple arguing noninfringement because “there is no change in shape
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`at all caused by [the material] only a change in size, which the parties agree is not
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`sufficient to meet the claims.”) (original emphasis); id. at 187 (arguing the Iwamiya
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`reference taught a second shape). Apple ultimately agreed that “a mere difference
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`in size is neither necessary nor sufficient to change a first shape into a ‘second
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`shape.’” EX2053, 3 n.1. Apple relied on that construction to argue noninfringement.
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`After relying on a construction to contest infringement, Apple cannot now avoid that
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`construction for patentability. Apple’s invalidity arguments here fail to address that
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`prior agreed construction or explain how its asserted references disclose a “second
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`shape” as properly construed. For example, as discussed below, Apple fails to
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`explain how its proposed combinations of Ackermans with Savant or Mendelson-
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`799 with Savant would result in a change from a “first shape” to a “second shape.”
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`Therefore, the Petition should be denied because Apple failed to identify “[h]ow the
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`challenged claim is to be construed.”
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`B.
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`The Specification and Prosecution History Drive the Proper
`Construction of “Second Shape”
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`Both the intrinsic record and the parties’ positions during the Investigation
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`confirm that “second shape” in Claims 1 and 20 means “a shape that is different than
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`the first shape, except that a mere difference in size is neither necessary nor sufficient
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`to change a first shape into a second shape.”
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`Masimo and Apple briefed the proper construction of “second shape” during
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`the Investigation. See EX2054, 21-24. The parties agreed that the specification
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`describes the “shape” of light according to the ordinary meaning of shape, describing
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`rectangles, squares, circles, and donuts. See, e.g., EX1001, 3:8-14, 8:9-12, 10:65-
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`11:2, Figs. 3, 7A, 7B; EX2052, 142; EX2054, 22. For example, the specification
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`explains that in Figure 7A a “light diffuser 704 receives the optical radiation emitted
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`from the emitter 702 and homogenously spreads the optical radiation over a wide,
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`donut-shaped area.” EX1001, 10:65-11:2; see also EX2002, ¶¶ 35-36.
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`IPR2022-01292
`Apple Inc. v. Masimo Corporation
`Claims 1 and 20 use the term “shape” consistent with the specification. Both
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`claims recite “a plurality of light-emitting diodes configured to emit light in a first
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`shape” and a “material configured to change the first shape into a second shape by
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`which the light emitted from one or more of the plurality of light-emitting diodes is
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`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
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`with the claimed “material.” EX2002, ¶ 37.
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`The prosecution history of a parent application also explains when a “second
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`shape” is different than a “first shape.” Specifically, during prosecution of U.S. Pat.
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`App. No. 16/532,065 (“the ’065 Application”), Masimo added then-pending claim 2
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`th