IPR 2021-00970
`Patent Owner’s Preliminary Response
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`APPLE, INC.,
`
`Petitioner,
`
`
`v.
`
`ALIVECOR, INC.,
`
`Patent Owner.
`
`______________
`
`Case IPR2021-00970
`Patent 9,572,499
`
`___________
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`Page
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`I.
`
`INTRODUCTION ........................................................................................... 1
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`II.
`
`THE ’499 PATENT ......................................................................................... 3
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`A. Overview ............................................................................................... 3
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`B.
`
`C.
`
`Background ........................................................................................... 4
`
`Specification .......................................................................................... 6
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`D.
`
`Prosecution History ............................................................................... 7
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`III. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 10
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`IV. THE ASSERTED PRIOR ART .................................................................... 13
`
`A.
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`Shmueli ................................................................................................ 13
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`B.
`
`C.
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`Osorio .................................................................................................. 14
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`Hu-1997 ............................................................................................... 16
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`V.
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`THE BOARD SHOULD EXERCISE ITS DISCRETION AND
`DENY INSTITUTION UNDER 35 U.S.C. § 314(a) .................................... 16
`
`A.
`
`B.
`
`C.
`
`D.
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`E.
`
`F.
`
`The ITC Will Not Stay The Investigation If IPR Is Instituted ............ 17
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`The ITC’s Investigation Will Conclude Before The Board’s
`Final Written Decision ........................................................................ 19
`
`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 .................................................. 23
`
`The Parties Are Identical In The Parallel ITC Proceedings ................ 27
`
`Other Considerations Also Weigh In Favor Of The Board
`Exercising Its Discretion To Deny Institution .................................... 27
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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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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 ............................................................................ 31
`
`A.
`
`B.
`
`C.
`
`The Asserted Motivation To Combine Shmueli and Osorio Is
`Conclusory, Unsupported, and Based On Impermissible
`Hindsight ............................................................................................. 31
`
`The Shmueli-Osorio Combination Does Not Disclose Key
`Elements Of The Independent Claims ................................................ 40
`
`Hu-1997 Does Not Cure The Deficiencies Of Shmueli And
`Osorio .................................................................................................. 42
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`VII. CONCLUSION .............................................................................................. 43
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`TABLE OF AUTHORITIES
`
`IPR 2021-00970
`Patent Owner’s Preliminary Response
`
`Cases
`
`Page(s)
`
`3Shape A/S et al. v. Align Technology, Inc.,
`IPR2020-00223, Paper 12 (May 26, 2020) ...................................................20
`
`ActiveVideo Networks, Inc. v. Verizon Commc’n, Inc.,
`694 F.3d. 1312 (Fed. Cir. 2012) ....................................................................37
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (March 20, 2020) ....................................... passim
`
`Arctic Cat Inc. v. Polaris Industries, Inc.,
`795 Fed. Appx. 827 (Fed. Cir. 2019) ............................................................36
`
`Avant Tech, Inc. v. Anza Tech., Inc.,
`IPR2018-00828, Paper 7 (Oct. 16, 2018) ......................................................37
`
`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) ...................................................19
`
`Cisco v. Ramot at Tel Aviv University,
`IPR2020-00122, Paper 15 (May 15, 2020) ...................................................27
`
`In re Deters,
`515 F.2d 1152 (CCPA 1975) .........................................................................12
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .....................................................................34
`
`Eli Lilly and Company v. Zenith Goldline Pharmaceuticals, Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) .....................................................................32
`
`Facebook v. USC IP Partnership,
`IPR2021-00033, Paper 13 (April 30, 2021) ........................................... 25, 26
`
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`Free-Flow Packaging Int’l v. Automated Packaging Systems, Inc.,
`IPR2016-00350, Paper 7 (Jun. 27, 2016) ......................................................36
`
`In re Fritch,
`972 F.2d 1260 (Fed. Cir. 1992) .....................................................................40
`
`In re Giannelli,
`739 F.3d 1375 (Fed. Cir. 2014) .....................................................................37
`
`Honda Motor Co., Ltd. v. Blitzsafe Texas, LLC,
`IPR2016-01473, Paper 9 (Jan.24, 2017) .......................................................37
`
`HVLPO2, LLC v. Oxygen Frog, LLC,
`949 F.3d 685, 689 (Fed. Cir. 2020) ...............................................................12
`
`Intel Corp. v. Hera Wireless S.A.,
`IPR2018-01686, Paper No. 10 at 5-6 (Nov. 8, 2019) ............................. 13, 17
`
`InTouch Techs., Inc. v. VGO Commc’ns, Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) .............................................................. 36, 40
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) .......................................................................35
`
`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) .....................................................39
`
`Nintendo Co., Ltd. v. Gamevice, Inc.,
`IPR2020-01197 Paper 13 (Jan. 12, 2021) .............................................. 21, 22
`
`In re Nuvasive, Inc.,
`842 F.3d 1376 (Fed. Cir. 2016) .....................................................................37
`
`PersonalWeb Techs., LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) .......................................................................37
`
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-00919, Paper 9 (Nov. 16, 2020) .............................................. 20, 27
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`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-01097, Paper 9 (January 19, 2021) ................................................27
`
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
`IPR2020-01602, Paper 9 (Apr. 2, 2021) ................................................. 26, 27
`
`Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, et al.,
`IPR2020-01317, Paper 15 (Jan. 15, 2021) .............. 19, 20, 21, 22, 23, 28, 30
`
`Roku v. Universal Electronics,
`IPR 2021-00263, Paper 11 (July 12, 2021) ............................................ 27, 30
`
`Samsung v. Clear Imaging Research,
`IPR2020-01399, Paper 13 (Feb. 3, 2021) ......................................................23
`
`Schott Gemtron Corp. v. SSW Holding Co., Inc., Case,
`IPR2013-00358, Paper 106 (Aug 20, 2014) ..................................................13
`
`Sharkninja v. iRobot,
`IPR2021-00544, Paper 7 (June 25, 2021) .....................................................27
`
`SK Innovation v. LG Chem,
`IPR2020-00987, Paper 14 (November 30, 2020) ..........................................27
`
`Sotera Wireless, Inc. v. Masimo Corp.,
`IPR2020-01019, Paper 12 (Dec. 1, 2020) ...................... 23, 24, 25, 26, 27, 29
`
`Sundance, Inc. v. DeMonte Fabricating Ltd.,
`550 F.3d 1356 (Fed. Cir. 2008) .....................................................................12
`
`Telebrands Corp. v. Tinnus Enterprises, LLC,
`PGR2016-00031, Paper 88 (Feb. 7, 2018) ....................................................37
`
`TQ Delta, LLC v. CISCO Sys., Inc.,
`942 F.3d 1352 (Fed. Cir. 2019) .....................................................................38
`
`Unigene Laboratories, Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .....................................................................32
`
`Wells Fargo Bank NA v. United Services Automobile Association,
`IPR2019-01082, Paper 41 (Nov. 24, 2020) ...................................................35
`
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`Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC,
`IPR2019-01393, Paper 24 (June 16, 2020) ...................................... 17, 18, 23
`
`Stanley Black & Decker, Inc. v. Zircon Corporation,
`IPR2020-01572, Paper 10 (April 19, 2021) ........................................... 19, 20
`
`Yorkey v. Diab,
`601 F.3d 1279 (Fed. Cir. 2010) .....................................................................13
`
`Statutory Authorities
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 314 ........................................................................................................31
`
`35 U.S.C. § 314(a) .................................................................................. 2, 16, 17, 31
`
`35 U.S.C. § 315(e)(2) ...............................................................................................24
`
`19 U.S.C. § 1337(b)(1)...................................................................................... 17, 18
`
`Rules and Regulations
`
`37 C.F.R. § 42.6 ......................................................................................................... 2
`
`37 C.F.R. § 42.24 ....................................................................................................... 1
`
`37 C.F.R. § 42.24(a) ................................................................................................... 1
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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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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
`
`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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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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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, IPR2021-00970 (Paper No. 2) (“Petition”) filed
`
`by Apple, Inc. (“Apple” or “Petitioner”). The Petition seeks review of claims 1-20
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`of U.S. Patent No. 9,572,499 (the “’499 Patent”) on two grounds, asserting that the
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`challenged claims are obvious based on (1) WIPO Publication No. WO 12/140559
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`(“Shmueli”) in combination with U.S. Patent Publication No. 2014/0275840
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`(“Osorio”) (claims 1-6, 10-16, and 20); and, (2) Shmueli in combination with
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`Osorio and Hu, et al., “A patient-adaptable ECG beat classifier using a mixture of
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`experts approach” (“Hu-1997”) (claims 7-9 and 17-19).
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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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`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 ’499
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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 ’499 Patent’s
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`validity months after an ITC Administrative Law Judge (“ALJ”) will have faced—
`
`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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`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 ’499
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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
`
`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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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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`None of Apple’s combinations establish obviousness of a single challenged
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`claim. To the contrary, both of the asserted grounds in the petition are based on
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`hindsight-driven combinations of prior art references that lack a motivation to
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`combine in the manner Apple proposes in its Petition. There is no reason that a
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`person of ordinary skill in the art (“POSITA”) would have been motivated to
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`combine the Shmueli and Osorio references that are central to both of Apple’s
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`asserted grounds for review, and the Shmueli and Osorio references expressly
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`teach away from the need to make the modifications that Apple proposes in order
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`to assert that the challenged claims are obvious. Moreover, even assuming that the
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`prior art references could be combined as Apple proposes, the Shmueli-Osorio
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`combination still fails to teach key elements of the independent claims. This failure
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`to establish obviousness of the independent claims is fatal to the Petition as a
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`whole.1
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`II. THE ’499 PATENT
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`A. Overview
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`The ’499 Patent was filed as Application No. 14/730,122 on June 3, 2015.
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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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`Ex. 1001 at 1. The inventors of the patent are Ravi Gopalakrishnan, Lev Korzinov,
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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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`Fei Wang, Euan Thompson, Nupur Srivastava, Omar Dawood, Iman Abuzeid, and
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`David E. Albert. Id. The patent was filed as a continuation of Application No.
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`14/569,513, filed on December 12, 2014. Id. The ’499 Patent also claims priority
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`to a series of provisional applications filed between December 12, 2013 and June
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`19, 2014. Id. at 1-2. The 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 1:25-30. 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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`bradyarrhythmia, respectively. Id. at 1:31-35; 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 atria of the heart is irregular, fast, and
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`disorganized, leading to irregular activation of ventricles. Id. at 1:36-40; Ex. 2001
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`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 40-42; 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 in 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 and development in this area to this day. Id.; Ex. 2003
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`The ’499 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’
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`improvement in detection techniques and equipment. Ex. 1001 at 1:20-2:4.
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`C.
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`Specification
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`The ’499 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 2:8-29. The ’499 Patent generally relates to methods and
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`devices AliveCor invented that enable a user to wear sensors that monitor the heart
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`and allow the user to record an ECG. Id. at 2:30-55, 10:1-18, 23:12-26, 24:58-25:4.
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`The ’499 Patent teaches sending the sensor data to a smartphone or a smartwatch
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`in order to determine whether a heart arrhythmia is or may be occurring. Id.
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`The ’499 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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`generated for recording an ECG reading on the device. Ex. 1001 at 25:17-22. As
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`the ’499 Patent states, “[b]y comparing measured heart rate changes with measured
`
`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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`25:22-25. 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
`
`convert the heart-related signals to an ECG electric signal.” Id. at 25:28-32.
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`The claims of the ’499 Patent recite specific and novel implementations of
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`apparatuses and methods used for detecting possible intermittent arrhythmias that
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`address the limitations in the prior art including the requirement that the users be
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`IPR 2021-00970
`Patent Owner’s Preliminary Response
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`made 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
`
`arrhythmia conditions. Ex. 2001 at 47.
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`D.
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`Prosecution History
`
`The application underlying the ’499 Patent was filed on June 3, 2015. Ex.
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`1002 at 662-63.
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`The examiner issued a non-final rejection on February 24, 2016, finding
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`inter alia original application claims 1-20 anticipated by U.S. Patent Publication
`
`No. 2012/0197148 to Levitan et al. See Ex. 1002 at 495-496. In response to the
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`examiner’s rejection, the applicant argued without amending the claims that
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`Levitan did not describe all of the recited features of the independent claims. Id. at
`
`374. The applicant explained that “Levitan does not describe receiving heart rate
`
`information from a heart rate sensor and determining a heart rate variability value
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`based on the user's heart rate as recited by claims” and that “Levitan does not
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`describe that the user is alerted to sense an electrocardiogram in response to a
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`determined heart rate variability value.” Id. (emphasis in original). The applicant
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`IPR 2021-00970
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`further explained that Levitan “describes the opposite of the recited features of
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`claims 1 and 11. Namely, Levitan describes the determination of an heart rate
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`variability value in response to a sensed electrocardiogram.” Id. at 374-375.
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`
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`Following the applicant’s remarks, the examiner issued a Final Rejection
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`Office Action on June 13, 2016, again concluded that claims 1-20 were anticipated
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`by Levitan. Ex. 1002 at 359. In response, the applicant amended independent
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`claims 1 and 11 to incorporate limitations directed to sensing an activity level of a
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`user and comparing the activity level to the user’s heart rate variability.
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`Specifically, claim 1 was amended as follows:
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`1. A method of determining a presence of an arrhythmia of a first
`user, said method comprising:
`
`sensing a heart rate of said first user with a heart rate sensor coupled
`to said first user;
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`transmitting said heart rate of said first user to a mobile computing
`device, wherein said mobile computing device is configured to sense
`an electrocardiogram;
`
`determining, using said mobile computing device, a heart rate
`variability of said first user based on said transmitted heart rate of said
`first user; [[and]]
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`sensing an activity level of said first user with a motion sensor;
`
`comparing, using said mobile computing device, said heart rate
`variability of said first user to said activity level;
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`alerting said first user to sense an electrocardiogram of said first user,
`using said mobile computing device, in response to an irregularity in
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`said heart rate variability.
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`Id. at 342.
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`The applicant explained that Levitan failed to teach or suggest these added
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`features because “Levitan does not, for example, describe use of a motion sensor
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`nor does Levitan describe either sensing an activity level of a user or comparing
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`an activity level of a user to an HRV value of the user.” Ex. 1002 at 345-346
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`(emphasis in original).
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`In light of these amendments and arguments, the examiner withdrew the
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`rejections based on Levitan and allowed the pending claims. Id. at 56-58. The
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`examiner included a “Statement of Reason for Allowability” in the Notice of
`
`Allowance, which found that “[t]he closest prior art, Levitan, fails to disclose,
`
`suggest and/or teach the claimed invention having a system and a method of
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`determining a presence of an arrhythmia of a first comprising a means of sensing
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`an activity level of said first user with a motion sensor and comparing a heart rate
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`variability of said first user to said activity level, in combination with the other
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`claimed elements.” Id. at 57. The applicant subsequently submitted an amendment
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`after the notice of allowance to correct certain language in the claims without
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`affecting claim scope, which was entered by the examiner on December 28, 2016,
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`resulting in the final language of the present claims. Id. at 34, 46-49.
`
`
`
`9
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`

`IPR 2021-00970
`Patent Owner’s Preliminary Response
`
`
`III. LEVEL OF ORDINARY SKILL IN THE ART
`
`Apple is incorrect that a POSITA in this field would only need “a
`
`combination of Bachelor’s Degree (or a similar Master’s Degree, or higher degree)
`
`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 8. It is insufficient that a POSITA working in the field of
`
`the ’499 Patent be defined in the general field of “health science.” Ex. 2001 at 48-
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`49.
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`The Summary of the Invention for the ’499 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 2:8-10, 30-32. A POSITA would need to understand
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`the specific aspects of the design, configuration, and operation of these devices,
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`which requires specialized engineering skills that a cardiologist may or may not
`
`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
`
`a POSITA that Apple has advanced in the parallel ITC action recognizes the need
`
`
`
`10
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`

`

`
`for exactly this type of engineering experience:
`
`IPR 2021-00970
`Patent Owner’s Preliminary Response
`
`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.
`
`Ex. 2004 at 6.
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`Apple’s alternative definition proposed here of a POSITA that does not
`
`include the requirement for prior engineering or design experience is intended to
`
`ensure that its expert, Dr. Chaitman, meets the definition of a POSITA and can
`
`offer competent testimony as to the obviousness of the challenged claims. 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 at 5. In addition, Dr.
`
`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. at 6-7
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`(emphases added). Dr. Chaitman does not state that he has any background
`
`involving the specialized engineering skills necessary for the design, configuration,
`
`
`
`11
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`

`
`and operation of portable computing devices that are the subject of the ’499 Patent.
`
`IPR 2021-00970
`Patent Owner’s Preliminary Response
`
`Ex. 2001 at 53-54.
`
`Dr. Chaitman’s lack of experience in the relevant field leads to several
`
`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
`
`to the filing of the ’499 Patent, and the extent to which a POSITA would be
`
`motivated to combine the asserted prior art references without the use of hindsight
`
`derived from the disclosures of the ’499 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
`
`claimed invention and the prior art, or the motivation of one of ordinary skill in the
`
`art to combine these references to achieve the claimed invention.” HVLPO2, LLC
`
`v. Oxygen Frog, LLC, 949 F.3d 685, 689 (Fed. Cir. 2020) (quoting Sundance, Inc.
`
`v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1364 (Fed. Cir. 2008); see also In re
`
`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
`
`and thus his opinion was “not evidence entitled to any weight in resolving the
`
`issue”). Dr. Chaitman’s testimony and opinions regarding the obviousness of the
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`’499 Patent should therefore be accorded little weight by the Board in deciding
`
`
`
`12
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`

`

`IPR 2021-00970
`Patent Owner’s Preliminary Response
`
`
`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
`
`F.3d 1279, 1284 (Fed. Cir. 2010)) (“The Board has broad discretion to
`
`assign weight to be accorded expert testimony.”); Schott Gemtron Corp. v. SSW
`
`Holding Co., Inc., Case IPR2013-00358, Paper 106 at 17-18 (Aug 20, 2014)
`
`(finding that the petitioner’s expert witness “does not qualify as a person of
`
`ordi