Filed: November 5, 2024
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`By: Brian C. Claassen (Reg. No. 63,051)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Perry D. Oldham (Reg. No. 52,082)
`Daniel C. Kiang (Reg. No. 79,631)
`Irfan A. Lateef (Reg. No. 51,922)
`Douglas B. Wentzel (Reg. No. 74,897)
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail:
`AppleIPR159-2@knobbe.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`Case IPR2024-00244
`U.S. Patent 10,722,159
`
`PATENT OWNER RESPONSE
`
`
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`By: Brian C. Claassen (Reg. No. 63,051)
`Carol Pitzel Cruz (Reg. No. 61,224)
`Perry D. Oldham (Reg. No. 52,082)
`Daniel C. Kiang (Reg. No. 79,631)
`Irfan A. Lateef (Reg. No. 51,922)
`Douglas B. Wentzel (Reg. No. 74,897)
`
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail:
`AppleIPR159-2@knobbe.com
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`Case IPR2024-00244
`U.S. Patent 10,722,159
`
`PATENT OWNER RESPONSE
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I. INTRODUCTION .................................................................................................. 1
`
`II. BACKGROUND ................................................................................................... 2
`
`A.
`
`B.
`
`The ’159 Patent ..................................................................................... 3
`
`Related Proceedings (37 C.F.R. § 42.8(b)(2)) ...................................... 6
`
`III. LEVEL OF ORDINARY SKILL IN THE ART ................................................. 6
`
`IV. CLAIM CONSTRUCTION................................................................................. 7
`
`“change the first shape into a second shape” ................................................. 7
`
`V. GROUNDS 1A, 1C, 1D, AND 1G (SARANTOS ALONE) FAIL
`TO DEMONSTRATE OBVIOUSNESS ........................................................ 8
`
`A. Apple Failed to Demonstrate That Sarantos Discloses
`Changing a First Shape of Light into a Different Second
`Shape (Claims 1 and 19) ...................................................................... 8
`
`1.
`
`2.
`
`3.
`
`Apple Admitted That Sarantos Does Not Disclose a
`Change in the Shape of Light...................................................... 9
`Light Transmitting Through Sarantos’s Window
`Would Not Change Shape ........................................................... 9
`Apple Should Be Estopped From Arguing
`Translucent or Transparent Materials Would
`Necessarily Change the Shape of Light ....................................14
`Sarantos Does Not Disclose the Claimed Array of
`Detectors and Light Block (Claim 5) ..................................................18
`
`B.
`
`C.
`
`Apple Represented That Sarantos Does Not Disclose a
`Diffuser (Claim 14) .............................................................................23
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`D.
`
`Sarantos Does Not Disclose a “Light Block Having a
`Circular Shape” (Claim 14) .................................................................24
`
`E.
`
`Apple Failed to Address Claim 24 ......................................................24
`
`VI. GROUNDS 1B, 1E, 1F, AND 1H (SARANTOS AND SHIE) FAIL
`TO DEMONSTRATE OBVIOUSNESS ......................................................25
`
`A. Apple Is Collaterally Estopped From Arguing a POSITA
`Would Have Been Motivated to Combine Sarantos and
`Shie (All Challenged Claims) .............................................................25
`
`1.
`
`2.
`
`The Parties Litigated the Same Issue of Whether a
`POSITA Would Have Been Motivated to Combine
`Sarantos and Shie in IPR2022-01465 .......................................26
`The Same Issue Was Actually Litigated in IPR2022-
`01465, Resolving It Was Essential to the Board’s
`Final Written Decision, and Apple Had a Full and
`Fair Opportunity to Litigate ......................................................30
`Apple’s Motivations to Combine Sarantos and Shie Fail on
`the Merits for the Same Reasons Decided Previously ........................31
`
`Apple Failed to Demonstrate That the Combination of
`Sarantos and Shie Would Change the Shape of Light ........................34
`
`B.
`
`C.
`
`D. Apple Failed to Demonstrate That Determining Oxygen
`Saturation at the Wrist Would Have Been Obvious In July
`2015 (Claims 8, 17) .............................................................................40
`
`1.
`
`2.
`
`Sarantos Does Not Disclose Determining Oxygen
`Saturation at the Wrist ..............................................................41
`Apple’s Engineers’ Testimony and Documents
`Reveal That a POSITA Would Not Have Had a
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`3.
`
`Reasonable Expectation of Success in Determining
`Oxygen Saturation at the Wrist in 2015 ....................................43
`Apple’s References Do Not Establish a Reasonable
`Expectation of Success .............................................................54
`Objective Evidence of Industry Skepticism, Failure
`of Others, and Long-Felt-But-Unmet Need Further
`Support Nonobviousness ..........................................................61
`VII. CONCLUSION ................................................................................................66
`
`4.
`
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Akamai Techs., Inc. v. Cable & Wireless Internet Servs., Inc.,
`344 F.3d 1186 (Fed. Cir. 2003) .......................................................................... 10
`Apple Inc. v. Masimo Corp.,
`IPR2024-00243, Paper 11 (PTAB July 9, 2024) ................................................ 22
`Boehringer Ingelheim Vetmedica, Inc. v. Schering–Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003) .......................................................................... 54
`Circuit Check Inc. v. QXQ Inc.,
`795 F.3d 1331 (Fed. Cir. 2015) .......................................................................... 62
`Gillette Co. v. S.C. Johnson & Son, Inc.,
`919 F.2d 720 (Fed. Cir. 1990) ............................................................................ 62
`Google LLC v. Hammond Dev. Int’l, Inc.,
`54 F.4th 1377 (Fed. Cir. 2022) ..................................................................... 25, 26
`Interconnect Planning Corp. v. Feil,
`774 F.2d 1132 (Fed. Cir. 1985) .......................................................................... 61
`Juniper Networks, Inc. v. Correct Transmission, LLC,
`No. 2023-1046, 2024 WL 3517862 (Fed. Cir. July 24, 2024) ........................... 60
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004) ............................................................................ 35
`M2M Sols. LLC v. Amazon.com, Inc.,
`No. 2022-1122, 2023 WL 2154964 (Fed. Cir. Feb. 22, 2023) ........................... 26
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) .................................................................... 51, 52
`Masimo Corp. v. Apple Inc.,
`Appeal Nos. 2024-1635, -1636 (Fed. Cir.) ........................................................... 6
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .......................................................................... 61
`Neptune Generics, LLC v. Eli Lilly & Co.,
`921 F.3d 1372 (Fed. Cir. 2019) .......................................................................... 62
`New Hampshire v. Maine,
`532 U.S. 742 (2001) ...................................................................................... 14, 15
`Ohio Williow Wood Co. v. Alps South,
`LLC, 735 F.3d 1333 (Fed. Cir. 2013) ........................................................... 25, 26
`SynQor, Inc v. Vicor Corp.,
`988 F.3d 1341 (Fed. Cir. 2021) .................................................................... 26, 30
`United States v. Adams,
`383 U.S. 39 (1966) ............................................................................ 62, 63, 65, 66
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.6 ....................................................................................................... 60
`37 C.F.R. § 42.8 ......................................................................................................... 6
`37 C.F.R. § 42.65 ....................................................................................................... 8
`
`
`
`-v-
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`EXHIBIT LIST
`
`2001
`
`Curriculum Vitae of Vijay K. Madisetti
`
`MN-JLH(D.Del. Feb. 10, 2023), D.I. 50
`
`Plaintiff Apple Inc.’s Opposition to Defendants’ Motion for Stay
`Pending Inter Partes Review (Public), Apple Inc. v. Masimo
`Corp., No. 22-1378-MN-JLH (D.Del. Jan. 10, 2024), D.I. 457
`
`2002
`
`2003
`
`004
`
`3005
`
`5006
`
`3007
`
`008
`
`009
`
`2010
`
`2011
`
`Expert Declaration of Vijay K. Madisetti in Support of Patent
`;
`.
`Owner’s Preliminary Response
`
`Commission Opinion (Public), Certain Light-Based
`Physiological Measurement Devices and Components Thereof,
`Inv. No. 337-TA-1276, EDIS No. 808521 (ITC Oct. 26, 2023)
`
`Decision DenyingInstitution ofInter Partes Review, Apple Inc.v.
`Masimo Corp., IPR2022-01271, Paper 15 (PTAB Jan. 24, 2023)
`
`Decision DenyingInstitution ofInter Partes Review, Apple Inc.v.
`Masimo Corp., 1PR2022-01272, Paper 16 (PTAB Jan. 24, 2023)
`
`Decision DenyingInstitution ofInter Partes Review, Apple Inc. v.
`Masimo Corp., IPR2022-01273, Paper 15 (PTAB Jan. 24, 2023)
`
`Decision DenyingInstitution ofInter Partes Review, Apple Inc.v.
`Masimo Corp., IPR2022-01274, Paper 15 (PTAB Jan. 24, 2023)
`
`Decision DenyingInstitution of Inter Partes Review, Apple Inc. v.
`Masimo Corp., IPR2022-01275, Paper 15 (PTAB Jan. 30, 2023)
`
`Decision DenyingInstitution of Inter Partes Review, Apple Inc. v.
`Masimo Corp., IPR2022-01276, Paper 15 (PTAB Jan. 30, 2023)
`
`Plaintiff Apple Inc.’s Opening Brief in Support of Its Motion for
`an Expedited Tnal, Apple Inc. v. Masimo Corp., No. 22-1377-
`
`Exhibit List, Page 1
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`2012
`
`013
`
`014
`
`015
`
`Transcript of May 5, 2023 Hearing in Apple Inc. v. Masimo
`Corp., Nos. 22-1377-MN-JLH, 22-1378-MN-JLH (D.Del. May
`5, 2023)
`
`Original Scheduling Order, Apple Inc. v. Masimo Corp., No. 22-
`1378-MN-JLH (D. Del. May 25, 2023), D.I. 92
`
`Amended Scheduling Order, Apple Inc. v. Masimo Corp., No. 22-
`1378-MN-JLH (D.Del. Sept. 21, 2023), D.I. 359
`
`Lex Machina Patent Case Timeline Statistics for the District of
`Delaware between December 12, 2022 and December 12, 2023
`
`2016
`
`Lex Machina CaseStatistics for Magistrate Judge Jennifer Hall
`
`2017
`
`Lex Machina CaseStatistics for Judge Colm Connolly, Judge
`Maryellen Noreika, Judge Richard Andrews, Judge Gregory
`Williams, and Magistrate Judge Jennifer Hall
`
`
`
`Aaron Tilley, The Entrepreneur Who Bet His Company on a
`Fight With Apple, Wall Street J., Dec. 30,
`2023, https://www.wsj.com/tech/joe-kiani-entrepreneur-apple-
`warning-52eb09a9
`
`2018
`
`019
`
`020
`
`021
`
`022
`
`Transcript of September 14, 2023 Markman Hearing, Apple Inc.
`v. Masimo Corp., Nos. 22-cv-1377-MN-JLH, 22-cv-1378-MN-
`JLH
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1271,
`Paper 20 (PTAB June 20, 2023)
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1272,
`Paper 20 (PTAB June 20, 2023)
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1273,
`Paper 19 (PTAB June 20, 2023)
`
`Exhibit List, Page 2
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`023
`
`024
`
`5025
`
`026
`
`027
`
`2028
`
`5029
`
`030
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1274,
`Paper 19 (PTAB June 20, 2023)
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1275,
`Paper 19 (PTAB June 26, 2023)
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1276,
`Paper 20 (PTAB June 26, 2023)
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1292,
`Paper 17 (PTAB Mar.7, 2023)
`
`Notice of Refund, Apple Inc. v. Masimo Corp., IPR2022-1466,
`Paper 17 (PTAB Apr. 5, 2023)
`
`June 6—10, 2022 Public Hearing Transcript, ITC Inv. No. 337-
`TA-1276
`
`Emails dated August-September 2022 between Apple’s and
`Masimo’s Counsel re IPR2022-01291 and -01465
`
`
`
`Correspondence from counsel for Apple to counsel for Masimo
`regarding Apple’s prior art grounds in the Delaware Litigation,
`dated November 16, 2023
`
`2031
`
`Email chain regarding false statements in IPR Petitions
`
`2032
`
`033
`
`034
`
`November17, 2023 Letter from U.S. Food & Drug
`Administration to Masimo Corp. re Masimo W1 510(k)
`Clearance
`
`Petition for Inter Partes Review, Apple Inc. v. Masimo Corp.,
`IPR2022-01292
`
`Petition for Inter Partes Review, Apple Inc. v. Masimo Corp..,
`IPR2022-01466
`
`Exhibit List, Page 3
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`035
`
`036
`
`037
`
`2038
`
`3039
`
`2040
`
`041
`
`042
`
`043
`
`Final Written Decision (Public Version), Apple Inc. v. Masimo
`Corp., IPR2022-01291 (Jan. 30, 2024)
`
`Final Written Decision (Public Version), Apple Inc. v. Masimo
`Corp., IPR2022-01465 (Feb. 2, 2024)
`
`Redacted Excerpt ofthe December 15, 2023 Rebuttal Report of
`Dr. Majid Sarrafzadeh
`
`Joint Claim Construction Statement Regarding Masimo Asserted
`Patents, Apple Inc. v. Masimo Corp., No. 22-1378-MN-JLH
`(Aug. 31, 2023)
`
`Petitioner’s Reply (Public Version), Apple Inc. v. Masimo Corp.,
`IPR2022-01291
`
`Excerpt of Apple’s Final Invalidity Contentions, Apple Inc.v.
`Masimo Corp., No. 1:22-cv-1378-JLH (D.Del.)
`
`MasimoPost-Hearing Brief (Public Version), ITC Inv. No. 337-
`TA-1276
`
`ITC Final Initial Determination (Public Version), ITC Inv. No.
`337-TA-1276
`
`2044-2049|RESERVED
`
`
`
`Order re Conduct of the Proceedings, Apple Inc. v. Masimo
`Corp., IPR2022-01291, Order Conduct of the Proceedings (Paper
`43)
`
`2050
`
`Apple Inc.’s Post-Hearing Brief (Public Version), ITC Inv. No.
`337-TA-1276
`
`
`
`2051-2055|RESERVED
`
`2056
`
`Excerpts of File History of App. No. 16/532,065
`
`Exhibit List, Page 4
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`2057
`
`Excerpts of File History of App. No. 15/195,199
`
`2058-2068|RESERVED
`
`069
`
`Eric W. Weisstein, Annulus, Wolfram MathWorld (Dec. 1, 2022,
`3:20 pm), https://mathworld.wolfram.com/Annulus.html
`
`2070-2071|RESERVED
`
`
`
`CONFIDENTIAL — ITC Exhibit CX-0289C — Designated
`Portions of February 10, 2022 Deposition of Dr. Paul
`Mannheimer
`
`2072
`
`Excerpt of Webster’s II New College Dictionary (2001)
`
`2073
`
`RESERVED
`
`074
`
`Nonconfidential Excerpt of Page 65 from June 6-10, 2022
`Hearing Transcript, ITC Inv. No 337-TA-1276
`
`2075
`
`RESERVED
`
`CONFIDENTIAL-Transcript of Testimony of Brian Land from
`076
`June 6-10, 2022 Hearing Transcript, Certain Light-Based
`Physiological Measurement Devices and Components Thereof,
`Inv. No. 337-TA-1276
`
`CONFIDENTIAL-Transcript of Testimony of Dr. Paul
`077
`Mannheimer from June 6-10, 2022 Hearing Transcript, Certain
`Light-Based Physiological Measurement Devices and
`Components Thereof, Inv. No. 337-TA-1276
`
`CONFIDENTIAL-—Transcript of Testimony of Dr. Stephen
`3078
`Waydo from June 6-10, 2022 Hearing Transcript, Certain Light-
`Based Physiological Measurement Devices and Components
`Thereof, Inv. No. 337-TA-1276
`
`2079
`
`RESERVED
`
`2080
`
`Exhibit List, Page 5
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`081
`
`082
`
`5083
`
`2084
`
`2085
`
`2086
`
`CONFIDENTIAL — ITC Exhibit CX-0299C — Designated
`Portions of February 18, 2022 Deposition of Dr. Stephen Waydo
`
`CONFIDENTIAL — ITC Exhibit CX-0295C — Designated
`Portions of February 11, 2022 Deposition of Tao Shui
`
`CONFIDENTIAL — ITC Exhibit CX-0007C — Email from Brian
`Landto Paul Mannheimeret al.
`
`CONFIDENTIAL -— ITC Exhibit CX-0175C — Apple
`or
`Organization Chart
`
`CONFIDENTIAL — ITC Exhibit CX-0177C — Apple Presentation
`
`CONFIDENTIAL — ITC Exhibit CX-0185C — Apple Presentation
`
`2087
`
`RESERVED
`
`2088
`
`
`
`ITC Exhibit CX-1616 — Fowler, Geoffrey, “The new Apple
`Watch says my lungs maybesick. Orperfect. It can’t decide.”
`Washington Post, September 23, 2020
`(https://www.washingtonpost.com/technology/2020/09/23/apple-
`watch-oximeter/)
`
`2089
`
`CONFIDENTIAL — ITC Exhibit CX-1793C — Apple Presentation
`
`2090
`
`RESERVED
`
`2091
`
`William, Andrews,“Fitbit Update Lets You Quickly Check Your
`Blood OxygenSaturation.” Forbes, Sept. 9, 2020
`(https://www.forbes.com/sites/andrewwilliams/2020/09/09/fitbit-
`update-lets-you-quickly-check-your-blood-oxygen-
`saturation/?sh=5d6ecb55e76a)
`
`092
`
`“Track Your SpO2 to Uncover Changes in Your Wellbeing,”
`Fitbit, Sept. 7, 2020 (https://blog.fitbit.com/track-your-spo2/)
`
`Exhibit List, Page 6
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`5093
`
`CONFIDENTIAL — ITC FinalInitial Determination (Public
`version filed as Exhibit 2043)
`
`
`
`2094 CONFIDENTIAL—Transcript ofNovember7, 2023 Deposition
`of Dr. Paul Mannheimer, Apple Inc. v. Masimo Corp.et al., Nos.
`22-1377-MN-JLH, 22-1378-MN-JLH (D. Del.)
`
`095
`
`Stein, “Withings Pulse O2 review: Fitness bandplusheart rate
`monitor checks blood oxygen, too,” CNET.com (April 25, 2014),
`https://www.cnet.com/reviews/withings-pulse-o2-review/
`(Previously filed as APPLE-1057 in IPR2022-01291)
`
`CONFIDENTIAL-Final Written Decision, Apple Inc.v.
`2096
`Masimo Corp., IPR2022-01291 (Jan. 30, 2024) (Public version
`previously filed as EX2035)
`
`
`
`CONFIDENTIAL - Excerpt of December 15, 2023 Expert Report
`ofMajid Sarrafzadeh, Ph.D. Regarding Non-InfringementofU.S.
`Patent Nos. 10,687,743 & 10,722,159, Apple Inc. v. Masimo
`Corp., C.A. Nos. 22-1377-MN-JLH, 22-1378-MN-JLH (D.Del.)
`
`097
`
`3098
`
`099
`
`100
`
`101
`
`Excerpt of C. A. Bennett, Principles of Physical Optics, John
`Wiley & Sons,Inc. (2008)
`
`Transcript ofHearing Held November 17, 2023 in IPR2022-
`01291, -01465 (Public Version)
`
`CONFIDENTIAL - Declaration ofVijay K. Madisetti, Ph.D. in
`Support of Patent Owner’s Response
`
`Document produced by Apple in related litigation bearing
`production numbers APL-MAS_00117783-877
`
`2102
`
`CONFIDENTIAL - Excerpt of documentproduced by Apple in
`related litigation bearing production numbers
`APL_DEL03985999-6078
`
`Exhibit List, Page 7
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`Documentproduced by Apple in related litigation bearing
`103
`production numbers APLMASITC_00311268-73
`
`(https://time.com/7094688/masimo-w1 -medical)
`
`“How to use the Blood Oxygen app on Apple Watch,” Apple Inc.
`(https://support.apple.com/en-us/120358)
`
`3104
`
`2105
`
`3106
`
`3107
`
`2108
`
`CONFIDENTIAL - Documentproduced by Apple in related
`litigation bearing production numbers APL-MAS_01812072-78
`
`Petition, Apple Inc. v. Masimo Corp., IPR2020-01722
`
`Transcript of October 28, 2024 Deposition ofBrian Anthony,
`Ph.D. and Deposition Exhibit 1 Thereto
`
`Chris Stokel-Walker, “A Stand-Out Health Tracker: Masimo W1
`Medical,” TIME,Oct. 30, 2024
`
`Exhibit List, Page 8
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`
`
`I. INTRODUCTION
`
`Apple’s Petition arises from parallel litigation in Delaware district court
`
`(“Delaware Litigation”). Apple was not, historically, a company that had any
`
`involvement in physiological monitoring technologies. But, around 2013, Apple
`
`decided to enter the field and sought out Masimo for its technology. Despite
`
`claiming an interest in integrating Masimo’s technology into Apple’s products,
`
`Apple began poaching Masimo’s employees, one after another. The poached
`
`employees included Chief Technical Officer Marcelo Lamego, an inventor of the
`
`three Masimo patents that the ITC recently found Apple infringed. Lamego took
`
`Masimo’s sensor design knowledge with him to Apple. And in the Delaware
`
`Litigation, Masimo accused Apple’s Watches of infringing Masimo’s patented
`
`technology, including key features disclosed and claimed in the ’159 Patent.
`
`Apple filed its Petition on the one-year deadline. But the Petition lacks merit
`
`for numerous reasons. Apple’s Sarantos-only grounds fail to show obviousness.
`
`The Board instituted this IPR based on Apple’s argument that Sarantos alone
`
`discloses a material that changes the shape of light. But Apple correctly conceded
`
`during IPR2022-01465 that Sarantos does not disclose changing the shape of light.
`
`And Apple should be estopped from arguing that light passing through a transparent
`
`or translucent material would “necessarily” change shape when it previously
`
`-1-
`
`
`
`IPR2024-00244
`Apple Inc. v. Masimo Corp.
`convinced the ITC that a translucent or transparent material in its own Apple Watch
`
`did not change the shape of light passing through it.
`
`Apple’s grounds based on Sarantos and Shie also fail. In IPR2022-01465, the
`
`Board correctly found that Apple failed to demonstrate a motivation to combine
`
`Sarantos and Shie. Apple never appealed the Board’s decision and Apple is now
`
`collaterally estopped from relitigating the same issue. Further, Apple failed to show
`
`that a POSITA would have been motivated to combine Sarantos and Shie, or would
`
`have reasonably expected the proposed combination to succeed. Indeed, Apple’s
`
`documents and the testimony of its own highly skilled engineers confirms a lack of
`
`reasonable expectation of success, and provides strong objective indicia of the
`
`nonobviousness of the challenged claims.
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`II. BACKGROUND
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`Masimo is the technology leader in the field of noninvasive physiological
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`monitoring. In 1989, Masimo was a small startup operating in an inventor’s condo.
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`Today, Masimo is a publicly traded company employing 6,300 people worldwide
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`with annual revenues exceeding $1.1 billion. Masimo technology is used in clinical
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`care to monitor over 200 million patients per year. This growth followed Masimo’s
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`development of a range of technologies that revolutionized the field of noninvasive
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`physiological monitoring. Other Masimo patents have withstood extensive attacks,
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`Apple Inc. v. Masimo Corp.
`including in litigation through trials, inter partes reexaminations, an ITC
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`investigation, IPRs, and appeals.
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`A. The ’159 Patent
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`Pulse oximetry is a method of noninvasively measuring the proportional
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`amount of hemoglobin carrying oxygen in blood, called arterial oxygen saturation
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`(abbreviated as SpO2). EX1009, 16, 23; EX2100, ¶36. Pulse oximeters measure
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`oxygen saturation by emitting light of at least two wavelengths, typically red and
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`infrared, into a user’s tissue and measuring the relative amounts of absorption of
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`those wavelengths. EX1001, 1:65-2:3; EX1009, 40; EX2100, ¶37. Based on the
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`relative amounts of detected light, a pulse oximeter can determine an oxygen
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`saturation value. EX2100, ¶38.
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`The ’159 Patent claims priority to a provisional application filed July 2, 2015.1
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`The patent describes and claims improvements to pulse oximetry sensors that
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`improve the accuracy of oxygen saturation measurements. EX1001, 1:22-26;
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`EX2100, ¶39. Before the ’159 Patent, conventional pulse oximetry used a “two-
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`dimensional” approach. EX1001, 5:41-50. In a 2D model, the path of light as it
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`penetrates tissue would be considered a two-dimensional vector. Id., 5:62-
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`1 Apple falsely alleged that Masimo withheld references from the Examiner during
`prosecution. Pet., 3-4, 83-84. Apple admitted those allegations were incorrect. See
`EX3001 (Apple requesting to strike such statements from its own petitions).
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`65. Conventional wisdom was that a focused point of light would reduce the
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`variability in the light’s pathlength through tissue and lead to more accurate
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`measurements. Id., 5:66-6:1.
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`The inventor, Al-Ali, recognized that light does not travel in straight paths
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`through tissue due to “multiple scattering” events. Id., 6:1-20. Al-Ali was able to
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`obtain more accurate oxygen saturation measurements by applying a “three-
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`dimensional” model to the tissue being measured. Id., 6:55-7:3. Rather than
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`irradiating tissue with a point source, Al-Ali added a material to change the shape of
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`light emitted towards the user’s tissue. Id., 6:21-54. This change in shape irradiates
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`a larger volume of tissue and provides a more accurate measurement. Id., 6:55-7:3;
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`EX2100, ¶40.
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`Al-Ali also recognized his new approach could detrimentally cause “light
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`piping.” Light piping occurs when the emitted light reaches the detectors without
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`first passing through tissue. EX1001, 7:25-29. The ’159 Patent discloses sensor
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`configurations to reduce light piping. Id., 7:16-29, 8:54-9:10. One approach uses
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`light blocks to inhibit LED light from reaching the detectors without first passing
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`through tissue. Id., 10:49-51, 11:10-20, Figs. 7A-7B. Another approach uses a dark-
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`colored coating to limit reflections between the user’s tissue and the sensor, leading
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`to pathlength variations that affect measurement accuracy. Id., 8:54-9:10; EX2100,
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`¶41. The claimed inventions provide novel combinations of these features that
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`improve measurements of oxygen saturation and other parameters from more
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`difficult sites like the wrist. Id., 1:22-26, 2:39-3:3, 10:40-51; EX2100, ¶42.
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`Based on Al-Ali’s research and the resulting ’159 Patent inventions, Masimo
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`developed a medical-grade wrist-based pulse oximeter that is now sold as the
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`Masimo W1, pictured below. EX2029, 248:24-250:14; EX2100, ¶43.
`
`
`The Masimo W1 is the only product on the market that provides continuous
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`oxygen saturation measurements at the wrist. On November 17, 2023, the Masimo
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`W1™ received FDA 510(k) clearance for over-the-counter and prescription use for
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`oxygen saturation monitoring. EX2032; EX2100, ¶44; EX2108. As of today,
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`Masimo is the first and only company in the world to receive FDA clearance for a
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`pulse oximeter that measures continuously at the wrist.
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`B. Related Proceedings (37 C.F.R. § 42.8(b)(2))
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`The parties previously litigated the validity of related claims in related U.S.
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`Patent No. 10,687,745 at the ITC and before the Board. In ITC Investigation
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`No. 337-TA-1276 (the “ITC Investigation”), the ITC upheld the validity of
`
`Claims 9, 18, and 27 of the ’745 Patent over the same Iwamiya and Sarantos
`
`references at issue here. See EX2093, 224-240. In IPR2022-01291 and IPR2022-
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`01465, the Board upheld the validity of Claims 13 and 25 of the ’745 Patent but
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`found the other challenged claims unpatentable. EX2035, EX2036. Masimo
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`appealed to the Federal Circuit, and that appeal is pending. Masimo Corp. v. Apple
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`Inc., Appeal Nos. 2024-1635, -1636 (Fed. Cir.). Apple did not appeal the Board’s
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`decision in IPR2022-01465 upholding the validity of Claims 13 and 25.
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`
`The Board adopted Petitioner’s definition of the level of ordinary skill in the
`
`art. Inst., 21-23; EX2100, ¶¶48-49. But Apple’s engineers, who vastly exceeded
`
`the level of ordinary skill in the art, expressed serious doubts that oxygen saturation
`
`could be measured from the wrist in July 2015 and failed to do so by that time. Thus,
`
`as explained below, Apple failed to show unpatentability under any proposed level
`
`of skill.
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`IV. CLAIM CONSTRUCTION
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`“change the first shape into a second shape”
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`Claims 1 and 19 both recite a “material configured to change the first shape
`
`into a second shape by which the light emitted from one or more of the plurality of
`
`emitters is projected towards [a surface of] the tissue measurement site.”2 The
`
`phrase does not require a specific first shape or second shape. However, as the
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`parties agreed in the Delaware Litigation, the second shape must be a “shape
`
`different from the first shape (not just a change in size).” EX2038, 5; EX2100, ¶50.
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`And the Board has likewise agreed that “this claim limitation in claims 1 and 19
`
`refers to different shapes rather than merely different sizes of the same shape.” Inst.,
`
`24.
`
`Notably, Apple never informed its expert, Anthony, that Apple agreed to this
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`construction of “second shape” months before Anthony’s declaration. EX2107,
`
`52:16-53:3, 60:9-62:1. Apple never explained why it withheld an agreed
`
`construction from its expert.
`
`
`2 Claim 19 omits “a surface of.”
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`V. GROUNDS 1A, 1C, 1D, AND 1G (SARANTOS ALONE)
`FAIL TO DEMONSTRATE OBVIOUSNESS
`
`A. Apple Failed to Demonstrate That Sarantos Discloses Changing a First
`Shape of Light into a Different Second Shape
`(Claims 1 and 19)
`
`Independent Claims 1 and 19 both require a “material configured to change
`
`the first shape into a second shape.” The Board instituted Apple’s Petition based on
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`Apple’s argument that Sarantos by itself discloses this limitation. Inst., 29 (citing
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`Pet., 9-10, EX1003, ¶35 (“light shining through a translucent or transparent material
`
`as described in the specific arrangement of Sarantos would necessarily change in
`
`shape due to the refractive properties of translucent and transparent materials”).3
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`But Apple’s argument was based entirely on Anthony’s unsupported
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`speculation. Pet., 9-10, 59; EX1003 ¶35. The Board should have rejected Apple’s
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`argument at the institution stage because Anthony’s unsupported opinion was
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`entitled to little or no weight. 37 C.F.R. § 42.65(a). Regardless, the Board should
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`reject Apple’s argument because (1) Apple admitted that Sarantos alone does not
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`disclose a change in the shape of light, (2) light transmitting through a flat
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`transparent or translucent window like in Sarantos does not change shape, and (3)
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`Apple should be estopped from arguing that a transparent or translucent material
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`would “necessarily” change the shape of light based on its successful argument at
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`3 All emphases added unless noted otherwise.
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`the ITC that its own microlens array, which is a transparent or translucent material,
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`did not change the shape of light. EX2100, ¶52.
`
`1.
`
`Apple Admitted That Sarantos Does Not Disclose a Change in the
`Shape of Light
`
` In IPR2022-01291 and IPR2022-01465 Apple raised Sarantos as prior art to
`
`the ’745 Patent. Apple expressly admitted that Sarantos does not disclose a material
`
`configured to change the shape of light from a first shape to a different second shape.
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`During oral argument in IPR2022-01291 and IPR2022-01465, Apple stated:
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`Sarantos doesn’t describe the material as configured to change the
`first shape of light entering the material from the light source 2208 to
`a different second shape of light exiting the material towards the
`tissue. And so, turning to slide 51, we see that Shie describes such
`material.
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`EX2099, 18:14-21. Apple’s admission was directed towards the “translucent or
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`transparent material” in Sarantos’s Figure 22, which Apple relied upon in the
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`Petition. Id.; Pet., 9-10. Apple thus correctly admitted that Sarantos does not
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`disclose a material configured to change the shape of light. EX2100, ¶53. Apple’s
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`prior admission should end the inquiry.
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`2.
`
`Light Transmitting Through Sarantos’s Window Would Not
`Change Shape
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`The Board recognized that Apple’s Sarantos-only argument was not a
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`“traditional obviousness modification and rationale” because Apple did not argue
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`that it “would have been obvious to modify Sarantos to include such a feature.” Inst.,
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`29. Instead, the Board understood Apple’s argument as “a POSITA, when
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`interpreting Sarantos, would understand that its translucent or transparent window
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`material would necessarily change the shape of the light.” Inst., 29; see Pet., 9-10
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`(“light shining through translucent or transparent material would change in shape
`
`due to the refractive properties of translucent and transparent materials”), EX1003
`
`¶35 (“light shining through a translucent or transparent material as described in the
`
`specific arrangement of Sarantos would necessarily change in shape due to the
`
`refractive properties of translucent and transparent materials”). Apple’s argument
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`that light passing through Sarantos’s window would “necessarily” change the shape
`
`of light is an inherency argument. See Akamai Techs., Inc. v. Cable & Wireless
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`Internet Servs., Inc., 344 F.3d 1186, 1192 (Fed. Cir. 2003) (“A claim limitation is
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`inherent in the prior art if it is necessarily present in the prior art, not merely probably
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`or possibly present.”). But Apple’s argument is wrong and is contrary to its
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`statements during oral argument in IPR2022-01291 and IPR2022-01465. EX2100,
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`¶54.
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`The prosecution history of parent application 16/532,065 confirms that there
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`are refractive materials that do not change the shape of the light. EX2100, ¶55.
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`Masimo interviewed the ’065 Application with the Examiner on February 13, 2020.
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`EX2056 at 162. The interview summary stated: “Agreement was reached that
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`Applicant’s proposed claim amendments, which reflect a change in shape of emitted
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`light beyond a change in size, defined over the Examiner’s citation of judicial notice
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`of emitted light passing through a lens.” Id. A POSITA would have understood that
`
`a lens magnifies images throu
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