`Patent Owner’s Preliminary Response
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`APPLE, INC.,
`
`Petitioner,
`
`
`v.
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`ALIVECOR, INC.,
`
`Patent Owner.
`
`______________
`
`Case IPR2021-00971
`Patent 10,595,731
`
`___________
`
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`IPR 2021-00971
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`TABLE OF CONTENTS
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`Page
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`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II.
`
`THE ‘731 PATENT ......................................................................................... 4
`
`A. Overview ............................................................................................... 4
`
`B.
`
`C.
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`Background ........................................................................................... 4
`
`Specification .......................................................................................... 6
`
`D.
`
`Prosecution History ............................................................................... 7
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`III. LEVEL OF ORDINARY SKILL IN THE ART ............................................. 8
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`IV. THE ASSERTED PRIOR ART .................................................................... 12
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`A.
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`Shmueli ................................................................................................ 12
`
`B.
`
`C.
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`Osorio .................................................................................................. 12
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`Li-2012 ................................................................................................ 14
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`D. Kleiger-2005 ........................................................................................ 15
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`E.
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`Chan ..................................................................................................... 15
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`V.
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION AND
`DENY INSTITUTION UNDER 35 U.S.C. § 314(a) .................................... 15
`
`A.
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`B.
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`C.
`
`D.
`
`The ITC Will Not Stay The Investigation If IPR Is Instituted ............ 16
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`The ITC’s Investigation Will Conclude Before The Board’s
`Final Written Decision ........................................................................ 18
`
`Significant Resources Will Be Invested In The ITC
`Investigation Before The Board Issues An Institution Decision. ....... 20
`
`The Invalidity Issues Raised In The Petition Substantially
`Overlap With The ITC Investigation. ................................................. 22
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`E.
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`F.
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`The Parties Are Identical In The Parallel ITC Proceedings ................ 26
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`Other Considerations Also Weigh In Favor Of The Board
`Exercising Its Discretion To Deny Institution .................................... 27
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`VI. APPLE FAILS TO SHOW A REASONABLE LIKELIHOOD THAT
`IT WILL PREVAIL WITH RESPECT TO AT LEAST ONE OF THE
`CHALLENGED CLAIMS ............................................................................ 30
`
`A.
`
`B.
`
`C.
`
`D.
`
`Shmueli Does Not Disclose Key Elements Of The Independent
`Claims .................................................................................................. 31
`
`The Asserted Motivation To Combine Shmueli and Osorio Is
`Conclusory, Unsupported, and Based On Impermissible
`Hindsight ............................................................................................. 33
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`The Shmueli-Osorio Combination Still Does Not Disclose Key
`Elements Of The Independent Claims ................................................ 41
`
`Li-2012, Kleiger-2005, and Chan Do Not Cure The
`Deficiencies Of Shmueli And Osorio ................................................. 42
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`VII. CONCLUSION .............................................................................................. 42
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`Table of Authorities
`
`Cases
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`Page(s)
`
`3Shape A/S et al. v. Align Technology, Inc.,
`IPR2020-00223, Paper 12 (May 26, 2020) ...................................................19
`
`ActiveVideo Networks, Inc. v. Verizon Commc’n, Inc.,
`694 F.3d. 1312 (Fed. Cir. 2012) ....................................................................38
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (March 20, 2020) ...........................................2, 16
`
`Arctic Cat Inc. v. Polaris Industries, Inc.,
`795 Fed. Appx. 827 (Fed. Cir. 2019) ............................................................37
`
`Avant Tech, Inc. v. Anza Tech., Inc.,
`IPR2018-00828, Paper 7 (Oct. 16, 2018) ......................................................38
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) .....................................................................36
`
`Canadian Solar Inc. v. The Solaria Corporation,
`IPR2021-00095, Paper 12 (May 26, 2021) ...................................................18
`
`Cisco v. Ramot at Tel Aviv University,
`IPR2020-00122, Paper 15 (May 15, 2020) ...................................................26
`
`In re Deters,
`515 F.2d 1152 (CCPA 1975) .........................................................................11
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .....................................................................35
`
`Eli Lilly and Company v. Zenith Goldline Pharmaceuticals, Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) .....................................................................33
`
`Facebook v. USC IP Partnership,
`IPR2021-00033, Paper 13 (April 30, 2021) ........................................... 24, 25
`
`Free-Flow Packaging Int’l v. Automated Packaging Systems, Inc.,
`IPR2016-00350, Paper 7 (Jun. 27, 2016) ......................................................37
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`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992) .....................................................................41
`
`In re Giannelli,
`739 F.3d 1375 (Fed. Cir. 2014) .....................................................................38
`
`Honda Motor Co., Ltd. v. Blitzsafe Texas, LLC,
`IPR2016-01473, Paper 9 (Jan.24, 2017) .......................................................38
`
`HVLPO2, LLC v. Oxygen Frog, LLC,
`949 F.3d 685 (Fed. Cir. 2020) .......................................................................11
`
`Intel Corp. v. Hera Wireless S.A.,
`IPR2018-01686, Paper No. 10 (Nov. 8, 2019) ....................................... 11, 17
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .............................................................. 38, 41
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .......................................................................36
`
`Kiosoft Techs., LLC v. Payrange, Inc.,
`No. IPR2021-00086, Paper 12 (Mar. 22, 2021) ............................................29
`
`Nautilus Hyosung Inc. v. Diebold, Inc.,
`IPR2016-00633, Paper 9 (Aug. 22, 2016) .....................................................40
`
`Nintendo Co., Ltd. v. Gamevice, Inc.,
`IPR2020-01197 Paper 13 (Jan. 12, 2021) .....................................................21
`
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) .....................................................................38
`
`PersonalWeb Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) .......................................................................38
`
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-00919, Paper 9 (Nov. 16, 2020) .....................................................19
`
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-01097, Paper 9 (January 19, 2021) ................................................26
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`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-01602, Paper 9 (Apr. 2, 2021) ................................................. 25, 26
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`Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, et al.,
`IPR2020-01317, Paper 15 (Jan. 15, 2021) .................... 18, 19, 21, 22, 27, 30
`
`Roku, Inc. v. Universal Electronics, Inc.,
`IPR2021-00263, Paper 11 (July 12, 2021) ............................................. 26, 30
`
`Samsung v. Clear Imaging Research,
`IPR2020-01399, Paper 13 (Feb. 3, 2021) ......................................................22
`
`Schott Gemtron Corp. v. SSW Holding Co., Inc., Case,
`IPR2013-00358, Paper 106 (Aug 20, 2014) ..................................................11
`
`Sharkninja v. iRobot,
`IPR2021-00544, Paper 7 (June 25, 2021) .............................................. 26, 27
`
`SK Innovation v. LG Chem,
`IPR2020-00987, Paper 14 (November 30, 2020) ................................... 26, 27
`
`Sotera Wireless, Inc. v. Masimo Corp.,
`IPR2020-01019, Paper 12 (Dec. 1, 2020) ............................ 22, 23, 24, 26, 28
`
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) .....................................................................11
`
`Telebrands Corp. v. Tinnus Enterprises, LLC,
`PGR2016-00031, Paper 88 (Feb. 7, 2018) ....................................................38
`
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d 1352 (Fed. Cir. 2019) .....................................................................40
`
`Unigene Laboratories, Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .....................................................................33
`
`Wells Fargo Bank NA v. United Services Automobile Association,
`IPR2019-01082, Paper 41 (Nov. 24, 2020) ...................................................36
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`Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC,
`IPR2019-01393, Paper 24 (June 16, 2020) ............................................ 17, 22
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`Stanley Black & Decker, Inc. v. Zircon Corporation,
`IPR2020-01572, Paper 10 (April 19, 2021) ..................................................18
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`Yorkey v. Diab,
`601 F.3d 1279 (Fed. Cir. 2010) .....................................................................11
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`Statutory Authorities
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`35 U.S.C. § 313 .......................................................................................................... 1
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`35 U.S.C. § 314 ........................................................................................................30
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`35 U.S.C. § 314(a) .................................................................................. 2, 15, 16, 30
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`35 U.S.C. § 315(e)(2) ........................................................................................ 23, 24
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`19 U.S.C. § 1337(b)(1).............................................................................................17
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`Rules and Regulations
`
`37 C.F.R. § 42.6 .......................................................................................................45
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`37 C.F.R. § 42.24 .....................................................................................................44
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`37 C.F.R. § 42.24(a) .................................................................................................44
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`Exhibit
`No.
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`Exhibit List
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`Description
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`2001 Declaration of Dr. Igor Efimov In Support of Patent Owner’s
`Preliminary Response
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`2002 B. S. Kim and S. K. Yoo, “Motion artifact reduction in
`photoplethysmography using independent component analysis,” IEEE
`Transactions on Biomedical Engineering, vol. 53, no. 3, pp. 566-568,
`March 2006, doi: 10.1109/TBME.2005.869784
`
`2003 Mao et al., Motion Artifact Reduction In Photoplethysmography For
`Reliable Signal Selection, arXiv, Sep 6, 2021; arXiv:2109.02755
`
`2004 Apple’s September 10, 2021 Disclosure of Initial Invalidity
`Contentions in Response to Individual Interrogatory Nos. 19-21 of
`AliveCor’s First Set of Interrogatories to Apple, In the Matter of
`Certain Wearable Electronic Devices with ECG Functionality and
`Components Thereof, Inv. No. 337-TA-1266
`
`2005 Certain Automated Storage and Retrieval Systems, Robots, and
`Components Thereof, Inv. No. 337-TA-1228, Order No. 6 Denying
`Respondents’ Motion For A Stay (Mar. 9, 2021)
`
`2006 Certain Wearable Electronic Devices with ECG Functionality and
`Components Thereof, Inv. No. 337-TA-1266, Order No. 6 Setting
`Procedural Schedule (June 25, 2021)
`
`2007 Respondent Apple Inc.’s Response to the Amended Complaint of
`AliveCor, Inc. Under Section 337 of the Tariff Act of 1930, As
`Amended, and Notice of Investigation, In the Matter of Certain
`Wearable Electronic Devices with ECG Functionality and
`Components Thereof, Inv. No. 337-TA-1266 (June 28, 2021) (Public)
`
`2008 Apple’s August 18, 2021 List of Claim Terms To Be Construed, In
`the Matter of Certain Wearable Electronic Devices with ECG
`Functionality and Components Thereof, Inv. No. 337-TA-1266
`
`2009
`
`Joint Disclosure Of Proposed Claim Constructions, In the Matter of
`Certain Wearable Electronic Devices with ECG Functionality and
`Components Thereof, Inv. No. 337-TA-1266 (Sept. 13, 2021)
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`vii
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`I.
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`INTRODUCTION
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`Pursuant to 35 U.S.C. § 313 and 37 C.F.R § 42.107, Patent Owner AliveCor,
`
`Inc. (“AliveCor” or “Patent Owner”) submits this Preliminary Response to the
`
`Petition for Inter Partes Review, IPR2021-00971 (Paper No. 2) (“Petition”) filed
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`by Apple, Inc. (“Apple” or “Petitioner”). The Petition seeks review of claims 1-30
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`of U.S. Patent No. 10,595,731 (the “‘731 Patent”) on five grounds, asserting that
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`(1) claims 1, 7, 12, 13, 16, 17, 23-26, and 30 are obvious based on WIPO
`
`Publication No. WO 12/140559 (“Shmueli”); (2) claims 1, 2, 4, 7, 12-14, 16-18,
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`20, 23-26, and 30 are obvious based on Shmueli in combination with U.S. Patent
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`Publication No. 2014/0275840 (“Osorio”); (3) claims 3, 5, 6, 19, 21, and 22 are
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`obvious based on Shmueli in combination with Osorio and Li, et al., “Signal
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`quality and data fusion for false alarm reduction in the intensive care unit” (“Li-
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`2012”); (4) claims 8-11 and 27-29 are obvious based on Shmueli in combination
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`with Osorio and Kleiger, et al., “Heart rate variability: measurement and clinical
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`utility” (“Kleiger-2005”); and, (5) claim 15 is obvious based on Shmueli in
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`combination with U.S. Patent No. 7,894,888 (“Chan”), or alternatively in
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`combination with Osorio and Chan.
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`AliveCor and Apple are currently engaged in far-ranging litigation in forums
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`across the country. In Washington, D.C., there is a pending Investigation at the
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`International Trade Commission (“ITC”) to assess Apple’s potential infringement
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`
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`1
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`of AliveCor’s patents. In Waco, Texas, there is a District Court patent infringement
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`action, currently stayed in favor of the ITC Investigation. In Oakland, California,
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`there is a pending District Court antitrust case evaluating whether Apple acted
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`anticompetitively to shut AliveCor and other competitors out of relevant markets,
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`including ECG-capable smartwatches, the technology at the heart of the ‘731
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`patent. With its Petition, Apple does not propose an alternative to those disputes.
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`Instead, it seeks to open yet another front so that it may have a second bite at the
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`proverbial invalidity apple—to have this Board weigh in on the ‘731 Patent’s
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`validity months after an ITC Administrative Law Judge (“ALJ”) will have faced—
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`and decided—the same issue. The judicial inefficiency and the risk of inconsistent
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`judgments that will arise from this parallel review are the exact issues that the
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`Board in Apple Inc. v. Fintiv, Inc., IPR2020-00019, sought to prevent. This Board,
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`therefore, should exercise its discretion under 35 U.S.C. § 314(a) to deny
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`institution, without reaching the merits of the Petition.
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`AliveCor is a leader in the design and development of products that provide
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`intelligent, highly-personalized heart data to help diagnose heart conditions. In
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`2017, AliveCor was first to bring to market an FDA cleared wearable consumer
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`device, the KardiaBand®, capable of monitoring the user’s heart, detecting heart
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`rate irregularities, and then allowing the user to perform an ECG to determine
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`potential atrial fibrillation (“AFib”). In doing so, it became the first to receive FDA
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`2
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`
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`clearance for a consumer use wearable medical device that allowed the user to
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`record an ECG reading. Similarly, the inventions described and claimed in the ‘731
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`Patent were groundbreaking, solving problems in the prior art that to this day
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`remain the subject of ongoing academic and industry research and investigation.
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`Indeed, during prosecution the examiner explicitly found that the closest prior art
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`of record did not disclose the combinations of sensors and functionality utilized for
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`detecting arrhythmia that are described in the claims.
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`None of Apple’s prior art references or combinations establish obviousness
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`of a single challenged claim. Apple’s assertion of Shmueli as a single reference to
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`establish obviousness fails because Shmueli lacks any disclosure of crucial
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`elements in the independent claims. The remaining grounds in the petition do not
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`teach the limitations that Shmueli lacks and are based on hindsight-driven
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`combinations of prior art references that lack a motivation to combine in the
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`manner Apple proposes in its Petition. There is no reason that a person of ordinary
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`skill in the art (“POSITA”) would have been motivated to combine the Shmueli
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`and Osorio references that are central to both of Apple’s asserted grounds for
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`review, and the Shmueli and Osorio references expressly teach away from the need
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`to make the modifications that Apple proposes in order to assert that the challenged
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`claims are obvious. Moreover, even assuming that the prior art references could be
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`combined as Apple proposes, the Shmueli-Osorio combination still fails to teach
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`3
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`key elements of the independent claims. This failure to establish obviousness of the
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`independent claims is fatal to the Petition as a whole.1
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`II. THE ‘731 PATENT
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`A. Overview
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`The ‘731 Patent was filed as Application No. 16/588,201 on September 30,
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`2019. Ex. 1001 at 1. The inventors of the patent are Ravi Gopalakrishnan, Lev
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`Korzinov, Fei Wang, Euan Thompson, Nupur Srivastava, Omar Dawood, Iman
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`Abuzeid, and David E. Albert. Id. The patent claims priority through a chain of
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`continuation applications to U.S. Patent 9,572,499—which is being challenged in
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`IPR2021-00970. Id. The patent also claims priority to a series of provisional
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`applications filed between December 12, 2013 and June 19, 2014. Id. at 1-2. The
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`patent is assigned to AliveCor, Inc.
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`B.
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`Background
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`Cardiovascular diseases are considered to be one of the leading causes of
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`death in the World. Ex. 1001 at 1:34-39. One common cardiac condition is
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`arrhythmia, which occurs when the electrical activity of the heart is irregular
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`and/or is faster or slower than normal, known as tachyarrhythmia and
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`
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`1 Apple’s Ground 2 is directed only to claims 7-9 and 17-19, which depend from
`claims 1 and 11 respectively. Because Ground 1 fails to show a reasonable
`likelihood that claims 1 and 11 are unpatentable, Ground 2 also fails.
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`4
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`bradyarrhythmia, respectively. Id. at 1:40-44; Ex. 2001 at 37. While certain forms
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`of arrhythmia are not considered life-threatening, some are known to cause cardiac
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`arrest that could lead to cardiac death. Id.; Ex. 2001 at 38. One of the most
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`common forms of cardiac arrhythmia is atrial fibrillation—which occurs when
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`electrical conduction through the ventricles of the heart is irregular and
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`disorganized, leading to irregular activation of ventricles. Id. at 1:44-49; Ex. 2001
`
`at 39. Atrial fibrillation is associated with atrial blood clot formation, which can
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`lead to clot migration and stroke. Id. at 1:49-51; Ex. 2001 at 39.
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`A photoplethysmogram (PPG) sensor can, among other things, monitor heart
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`rate using an optical detection of blood volume changes in the microvascular bed
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`of the tissue. Ex. 2001 at 40. The PPG sensor system consists of a light source(s)
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`and a detector(s). Id. PPG sensor(s) monitor changes in the light intensity of light
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`reflected from or transmitted through the tissue. Id. The changes in light intensity
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`are associated with small variations in blood perfusion of the tissue, caused by
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`cardiac contractions, and provide information on the cardiovascular system. Id.
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`PPG monitoring is reliable in measurements of oxygen saturation and
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`average heart rate, but historically has been found to be less reliable in detecting
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`arrhythmias, especially atrial arrhythmias. Ex. 2001 at 41. Compared to the
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`traditional ECG data, heart rate estimation is more challenging when using a PPG-
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`signal. Id. In particular, motion artifacts, caused by the user’s physical activity
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`(e.g., arm movement), can create noisy signals resulting significantly reduced
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`PPG-signal quality. Ex. 2001 at 42; Ex. 2002. As a result, it is difficult to obtain a
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`clean signal and extract HR from contaminated PPG. Id. Therefore, increasing the
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`accuracy and robustness of PPG-based heart rate estimation remains at the
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`forefront of research in this area even to this day. Id.; see also Ex. 2003.
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`The ‘731 Patent explains the state of the art in arrhythmia detection, the
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`limitations in known techniques and equipment, and the need for the inventors’
`
`improvement in detection techniques and equipment. Ex. 1001 at 1:29-2:13
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`C.
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`Specification
`
`The ‘731 Patent teaches systems and methods that allow for an increased
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`efficacy and convenience of heart monitoring for arrhythmias like atrial
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`fibrillation. Ex. 1001 at 2:17-38. The ‘731 Patent generally relates to methods and
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`devices AliveCor invented that enable a user to wear sensors that would monitor
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`the heart and allow the user to record an ECG. Id. at 2:39-64, 10:10-28, 23:20-34,
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`24:66-25:12. The ‘731 Patent teaches sending the sensor data to a smartphone or a
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`smartwatch in order to determine whether a heart arrhythmia is or may be
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`occurring. Id.
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`The ‘731 Patent teaches that “when a measured heart rate increases rapidly
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`without a corresponding increase in activity monitored by, for example, an
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`accelerometer” found on a mobile device, then an “advisory condition” is
`
`
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`6
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`generated for recording an ECG reading on the device. Ex. 1001 at 25:25-30. As
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`the ‘731 Patent notes, “[b]y comparing measured heart rate changes with measures
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`activity changes, the presently disclosed software or ‘app’ minimizes false alarms”
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`that would otherwise occur in prior art methods sensing only heart rate. Id. at
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`25:30-33. The ECG sensors on the device include “an electrode assembly
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`configured to sense heart-related signals upon contact with a user’s skin, and to
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`convert the heart-related signals to an ECG electric signal.” Id. at 25:36-40.
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`The claims of the ‘731 Patent recite specific and novel implementations of
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`apparatus and methods used for diagnosing intermittent arrhythmias that address
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`the limitations in the prior art including the requirement that the users be made
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`aware of the potentially life-threatening arrhythmia and have ready access to
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`specialized diagnostic equipment in a clinical setting. Ex. 2001 at 46. The claimed
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`inventions thus offer a uniquely convenient heart monitoring apparatus and
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`methods that leverages wearability, specialized sensors, and machine learning to
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`generate more accessible and effective detection of potentially dangerous
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`arrhythmia conditions. Ex. 2001 at 47.
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`D.
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`Prosecution History
`
`The application underlying the ‘731 Patent was filed on September 30, 2019.
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`Ex. 1002 at 152-153.
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`After AliveCor overcame a non-statutory double patenting rejection from the
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`examiner by filing a terminal disclaimer, the examiner issued a Notice of
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`Allowance on February 3, 2020. Ex. 1002 at 25-32, 51-52, 64-66, 73-76. The
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`examiner included a “Statement of Reason for Allowability” in the Notice of
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`Allowance, which found that “[t]he closest prior art, Levitan (as cited by
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`14/730122), fails to disclose, suggest and/or teach the claimed invention having a
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`smart watch and a method of determining a presence of an arrhythmia of a first
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`comprising a means of sensing an activity level of said first user with a motion
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`sensor and comparing a heart rate variability of said first user to said activity level,
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`in combination with the other claimed elements.” Id. at 31.
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`III. LEVEL OF ORDINARY SKILL IN THE ART
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`Apple is incorrect that a POSITA in this field would only need “a
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`combination of Bachelor’s Degree (or a similar Master’s Degree, or higher degree)
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`in an academic area emphasizing health science, or a related field, and two or more
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`years of work experience with cardiac monitoring technologies (e.g., a
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`cardiologist).” Petition at 7-8; see also Ex. 1003, ¶10. It is insufficient that a
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`POSITA working in the field of the ‘731 Patent be defined in the general field of
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`“health science.” Ex. 2001 at 48-49.
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`The Summary of the Invention for the ‘731 Patent includes “devices,
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`systems, and methods for managing health and disease such as cardiac diseases,
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`including arrhythmia and atrial fibrillation” and the use of “[a] portable computing
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`device” that is specifically configured to “measure one or more physiological
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`signals of a user.” Ex. 1001 at 2:17-19, 39-41. A POSITA would need to
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`understand the specific aspects of the design, configuration, and operation of these
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`devices, which are specialized engineering skills that a cardiologist may or may not
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`possess in his or her background. Ex. 2001 at 50-51. As a result, a degree in
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`biomedical or electrical engineering (or an equivalent), and/or extensive
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`experience working with tools for detecting cardiac conditions, including
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`arrhythmias, would be necessary. Ex. 2001 at 52. Indeed, the primary definition of
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`a POSITA that Apple has advanced in the parallel ITC action recognizes the need
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`for exactly this type of engineering experience:
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`A person having ordinary skill in the art (“PHOSITA”) at the time of
`the alleged invention in December 2013 (the alleged priority for
`the ’499 and ’731 patents) would have at least a bachelor of science in
`electrical
`engineering, mechanical
`engineering,
`biomedical
`engineering, computer science, or a related discipline, with at least two
`years of relevant work experience designing wearable devices and/or
`sensors for measuring physiological signals or parameters of mammals.
`A greater amount of education, i.e., a doctorate in electrical
`engineering, mechanical engineering, biomedical engineering,
`computer science, or a related discipline with a focus on designing
`wearable devices and/or sensors for measuring physiological signals or
`parameters of mammals would also qualify for the hypothetical person
`of ordinary skill in the art in lieu of fewer years of work experience.
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`Ex. 2004 at 6.
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`Apple’s alternative POSITA definition proposed to this body does not
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`include the requirement for prior engineering or design experience, which is
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`intended to ensure that its expert, Dr. Chaitman, meets the definition of a POSITA
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`and can offer competent testimony as to the obviousness of the challenged claims.
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`For example, Dr. Chaitman only states that his background includes a “Bachelor of
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`Science” degree, without specifying the field. Ex. 1003, ¶6. In addition, Dr.
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`Chaitman’s described experience is also limited to “the use of the rest and
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`exercise ECG as a diagnostic instrument” and “matters related to ECG analysis
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`and the use of ECG analysis as a diagnostic and prognostic tool.” Id., ¶¶ 6-8.
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`(emphases added). Dr. Chaitman does not state that he has any background
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`involving the specialized engineering skills necessary for the design, configuration,
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`and operation of portable computing devices that are the subject of the ‘731 patent.
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`Ex. 2001 at 53-54.
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`Dr. Chaitman’s lack of experience in the relevant field leads to several
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`misplaced assumptions in his declaration concerning the limitations of PPG signal
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`processing technology, what a POSITA would understand to exist in the field prior
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`to the filing of the ‘731 Patent, and the extent to which a POSITA would be
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`motivated to combine the asserted prior art references without the use of hindsight
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`derived from the disclosures of the ‘731 Patent itself. Ex. 2001 at 55. “[A] witness
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`not qualified in the pertinent art [may not] testify as an expert on obviousness, or
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`any of the underlying technical questions, such as the nature of the claimed
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`invention, the scope and content of the prior art, the differences between the
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`claimed invention and the prior art, or the motivation of one of ordinary skill in the
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`art to combine these references to achieve the claimed invention.” HVLPO2, LLC
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`v. Oxygen Frog, LLC, 949 F.3d 685, 689 (Fed. Cir. 2020) (quoting Sundance, Inc.
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`v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1364 (Fed. Cir. 2008); see also In re
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`Deters, 515 F.2d 1152, 1155 (CCPA 1975) (rejecting patent expert testimony on
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`nonobviousness where patent expert was not a person ordinarily skilled in the art
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`and thus his opinion was “not evidence entitled to any weight in resolving the
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`issue”). Dr. Chaitman’s testimony and opinions regarding the obviousness of the
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`’731 Patent should therefore be accorded little weight by the Board in deciding
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`whether to institute inter partes review. Intel Corp. v. Hera Wireless S.A.,
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`IPR2018-01686, Paper No. 10 at 5-6 (Nov. 8, 2019) (citing Yorkey v. Diab, 601
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`F.3d 1279, 1284 (Fed. Cir. 2010)) (“The Board has broad discretion to
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`assign weight to be accorded expert testimony.”); Schott Gemtron Corp. v. SSW
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`Holding Co., Inc., Case IPR2013-00358, Paper 106 at 17-18 (Aug 20, 2014)
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`(finding that the petitioner’s expert witness “does not qualify as a person of
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`ordinary skill in the art” and thus “we accord the testimony of [the expert witness]
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`regarding the alleged obviousness of the claims less weight because he was not a
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`person of ordinary skill in the art at the time of the invention”)).
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`IV. THE ASSERTED PRIOR ART
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`A.
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`Shmueli
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`Shmueli is titled “Pulse Oximetry Measurement Triggering ECG
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`Measurement.” Ex. 1004 at 1. According to the Abstract, Shmueli discloses a
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`“method and a system for triggering the measurement of electrocardiogram (ECG)
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`signal of a user” by “continuously measuring SpO2 at the wrist of the user,
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`detecting an irregular heart condition from the SpO2 measurement, notifying the
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`user to perform an ECG measurement, and initiating the ECG measurement at least
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`partially at the wrist.” Ex. 1004 at 1; Ex. 2001 at 57.
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`Shmueli explains that the problem it is seeking to solve is that the prior art
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`“does not consider a requirement to enable a patient to perform ECG measurement
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`as soon as an irregular heart activity develops and without requiring the ECG to be
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`constantly wired to the patient.” Ex. 1004 at 9; Ex. 2001 at 58. Shmueli states this
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`problem is addressed “by providing a combined oximetry and electrocardiogram
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`measuring system and a method in which the oximetry measurement is performed
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`continuously and/or repeatedly, and the ECG measurement is triggered upon
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`detection of an intermittent irregular heart-related event.” Id.; Ex. 2001 at 58.
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`B. Osorio
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`Osorio is titled “Pathological State Detection Using Dynamically
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`Determined Body Data Variability Range Values.” The Abstract states that the
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`invention disclosed is directed to detecting a “pathological body state of a patient”
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`by determining when a body data variability value, or “BDV,” is outside of a
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`“value range.”