IPR 2021-00972
`Patent Owner’s Preliminary Response
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`APPLE, INC.,
`
`Petitioner,
`
`
`v.
`
`ALIVECOR, INC.,
`
`Patent Owner.
`
`______________
`
`Case IPR2021-00972
`Patent 10,638,941
`
`___________
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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`IPR 2021-00972
`Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`Page
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`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II.
`
`THE ‘941 PATENT ......................................................................................... 4
`
`A. Overview ............................................................................................... 4
`
`B.
`
`C.
`
`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
`
`A.
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`Shmueli ................................................................................................ 12
`
`B.
`
`C.
`
`Osorio .................................................................................................. 13
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`Lee-2013 .............................................................................................. 15
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`D.
`
`Chan ..................................................................................................... 15
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`V.
`
`THE BOARD SHOULD EXERCISE ITS DISCRETION AND
`DENY INSTITUTION UNDER 35 U.S.C. § 314(a) .................................... 15
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`A.
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`B.
`
`C.
`
`D.
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`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
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`Significant Resources Will Be Invested In The ITC
`Investigation Before The Board Issues An Institution Decision ........ 19
`
`The Invalidity Issues Raised In The Petition Substantially
`Overlap With The ITC Investigation .................................................. 22
`
`E.
`
`The Parties Are Identical In The Parallel ITC Proceedings ................ 26
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`Patent Owner’s Preliminary Response
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`F.
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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.
`
`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
`
`Lee-2013 and Chan Do Not Cure The Deficiencies Of Shmueli
`And Osorio .......................................................................................... 41
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`VII. CONCLUSION .............................................................................................. 42
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`IPR 2021-00972
`Patent Owner’s Preliminary Response
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`Table of Authorities
`
`Cases
`
`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) ...................................................................36
`
`Alivecor, Inc. v. Apple, Inc.,
` Case No. 4:21-cv-03958-JSW (N.D. Cal.) ...................................................27
`
`Apple Inc. v. Fintiv, Inc.,
` IPR2020-00019, Paper 11 (March 20, 2020) ............. 2, 16-22, 26, 27, 29, 30
`
`Arctic Cat Inc. v. Polaris Industries, Inc.,
` 795 Fed. Appx. 827 (Fed. Cir. 2019) ...........................................................35
`
`Avant Tech, Inc. v. Anza Tech., Inc.,
` IPR2018-00828, Paper 7 (Oct. 16, 2018) .............................................. 37, 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
`
`Certain Automated Storage and Retrieval Systems, Robots, and Components
`Thereof,
` Order No. 6 (337-TA-1228) .................................................................. 16, 17
`
`Certain Wearable Electronic Devices with ECG Functionality and
` Components Thereof, Inv. No. 337-TA-1266, Order No. 6 Setting
` Procedural Schedule (June 25, 2021) .............................................. 19, 20, 21
`
`Cisco v. Ramot at Tel Aviv University,
` IPR2020-00122, Paper 15 (May 15, 2020) ..................................................26
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) .....................................................................34
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`Eli Lilly and Company v. Zenith Goldline Pharmaceuticals, Inc.,
` 471 F.3d 1369 (Fed. Cir. 2006) ....................................................................31
`
`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 at 14 (Jun. 27, 2016) ............................................35
`
`Honda Motor Co., Ltd. v. Blitzsafe Texas, LLC,
` IPR2016-01473, Paper 9 at 16 (Jan.24, 2017) .............................................36
`
`HVLPO2, LLC v. Oxygen Frog, LLC,
` 949 F.3d 685 (Fed. Cir. 2020) ......................................................................11
`
`In re Deters,
` 515 F.2d 1152 (CCPA 1975) ........................................................................11
`
`In re Fritch,
` 972 F.2d 1260 (Fed. Cir. 1992) ....................................................................39
`
`In re Giannelli,
` 739 F.3d 1375 (Fed. Cir. 2014) ............................................................. 24, 36
`
`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
`
`In re Nuvasive, Inc.,
` 842 F.3d 1376 (Fed. Cir. 2016) ....................................................................36
`
`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) ............................................................. 36, 39
`
`Nautilus Hyosung Inc. v. Diebold, Inc.,
` IPR2016-00633, Paper 9 (Aug. 22, 2016) ....................................................38
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`Nintendo Co., Ltd. v. Gamevice, Inc.,
`IPR2020-01197 Paper 13 (Jan. 12, 2021) .............................................. 20, 21
`
`PersonalWeb Techs., LLC v. Apple, Inc.,
` 848 F.3d 987 (Fed. Cir. 2017) ......................................................................36
`
`Philip Morris I; Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
` IPR2020-01097, Paper 9 (January 19, 2021) ...............................................26
`
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
` IPR2020-00919, Paper 9 (Nov. 16, 2020) ............................................. 19, 26
`
`Philip Morris Products, S.A. v. RAI Strategic Holdings, Inc.,
` IPR2020-01602, Paper 9 (Apr. 2, 2021) ................................................ 25, 26
`
`Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, et al.,
`IPR2020-01317, Paper 15 (Jan. 15, 2021) ..................... 18, 19, 21, 22, 27, 29
`
`Roku, Inc. v. Universal Electronics, Inc.,
` IPR2021-00263, Paper 11 (July 12, 2021) ........................................... 26, 29
`
`Samsung v. Clear Imaging Research,
` IPR2020-01399, Paper 13 (Feb. 3, 2021) .....................................................22
`
`Sand Revolution II, LLC v. Continental Intermodal Group-Trucking LLC,
` IPR2019-01393, Paper 24 (June 16, 2020) ........................................... 17, 22
`
`Schott Gemtron Corp. v. SSW Holding Co., Inc., Case,
` IPR2013-00358, Paper 106 (Aug 20, 2014) .......................................... 11, 12
`
`Sharkninja v. iRobot,
` IPR2021-00544, Paper 7 (June 25, 2021) ....................................................26
`
`SK Innovation v. LG Chem,
` IPR2020-00987, Paper 14 (November 30, 2020) .........................................26
`
`Sotera Wireless, Inc. v. Masimo Corp.,
`IPR2020-01019, Paper 12 (Dec. 1, 2020) ..................... 22, 23, 25, 26, 28, 29
`
`Stanley Black & Decker, Inc. v. Zircon Corporation,
`IPR2020-01572, Paper 10 (April 19, 2021) ..................................................19
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`Sundance, Inc. v. DeMonte Fabricating Ltd.,
` 550 F.3d 1356 (Fed. Cir. 2008) ....................................................................11
`
`Telebrands Corp. v. Tinnus Enterprises, LLC, PGR2016-00031, Paper,
` 88 at 35 (Feb. 7, 2018) ..................................................................................36
`
`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) ................................................. 31, 32, 33, 34
`
`Wells Fargo Bank NA v. United Services Automobile Association,
` IPR2019-01082, Paper 41 (Nov. 24, 2020) ..................................................35
`
`Yorkey v. Diab,
`601 F.3d 1279 (Fed. Cir. 2010) .....................................................................11
`
`Statutory Authorities
`
`19 U.S.C. § 1337 (b)(1)..................................................................................... 16, 17
`
`35 U.S.C. § 313 .......................................................................................................... 1
`
`35 U.S.C. § 314 ........................................................................................................30
`
`35 U.S.C. § 314(a) ................................................................................... 2, 15, 16, 30
`
`35 U.S.C. § 315(e)(2) ...............................................................................................23
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`Rules and Regulations
`
`37 C.F.R § 42.107 ...................................................................................................... 1
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`IPR 2021-00972
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`Exhibit
`No.
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`EXHIBIT LIST
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`Description
`
`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)
`
`vii
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`IPR 2021-00972
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`2010
`
`Issue Notification and Notice of Allowance for U.S. Patent No.
`9,839,363
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`viii
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`IPR 2021-00972
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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, IPR2021-00972 (Paper No. 2) (“Petition”) filed
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`by Apple, Inc. (“Apple” or “Petitioner”). The Petition seeks review of claims 1-23
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`of U.S. Patent No. 10,638,941 (the “‘941 Patent”) on three grounds, asserting that
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`(1) claims 1, 5, 7-9, 11, 12, 16, 18-20, 22, and are obvious based on WIPO
`
`Publication No. WO 12/140559 (“Shmueli”) in combination with U.S. Patent
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`Publication No. 2014/0275840 (“Osorio”); (2) claims 2-4, 6, 13-15, and 17 are
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`obvious based on Shmueli in combination with Osorio and Lee, et al., “Atrial
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`Fibrillation Detection using a Smart Phone” (“Lee-2013”); and, (3) claims 10 and
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`U.S. Patent No. 7,894,888 (“Chan”).
`
`AliveCor and Apple are currently engaged in far-ranging litigation in forums
`
`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 ‘941
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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 ‘941 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
`
`clearance for a consumer use wearable medical device that allowed the user to
`
`record an ECG reading. Similarly, the inventions described and claimed in the ‘941
`
`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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`IPR 2021-00972
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`detecting arrhythmia that are described in the claims.
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`None of Apple’s asserted prior art combinations establish obviousness of a
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`single challenged claim. To the contrary, all of the asserted grounds in the petition
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`are based on hindsight-driven combinations of prior art references that lack a
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`motivation to combine in the manner Apple proposes in its Petition. There is no
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`reason that a person of ordinary skill in the art (“POSITA”) would have been
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`motivated to combine the Shmueli and Osorio references that are central to all of
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`Apple’s asserted grounds for review, and the Shmueli and Osorio references
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`expressly teach away from the need to make the modifications that Apple proposes
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`in order to assert that the challenged claims are obvious. Moreover, even assuming
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`that the prior art references could be combined as Apple proposes, the Shmueli-
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`Osorio combination still fails to teach key elements of the independent claims. This
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`failure to establish obviousness of the independent claims is fatal to the Petition as
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`a whole.1
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`
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`1 Apple’s Grounds 2 and 3 are directed only to claims which depend from
`independent claims 1 and 12 that are only challenged in Ground 1. Because
`Ground 1 fails to show a reasonable likelihood that claims 1 and 12 are
`unpatentable, Grounds 2 and 3 also fail.
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`II. THE ‘941 PATENT
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`A. Overview
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`The ‘941 Patent was filed as Application No. 16/158,112 on October 11,
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`2018. Ex. 1001 at 1. The inventors of the patent are David E. Albert, Omar
`
`Dawood, Ravi Gopalakrishnan, Fei Wang, Euan Thomson, and Iman Abuzeid. Id.;
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`see also Ex. 1002 at 1-11. The patent was filed as a continuation of U.S. Patent No.
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`10,537,250, filed on July 21, 2017, which itself was a continuation of U.S. Patent
`
`No. 9,839,363, filed on May 13, 2016. Ex. 1001 at 1. The ‘941 Patent also claims
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`priority to Provisional Application No. 62/161,092, filed on May 13, 2015. Id. 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, and in particular irregular heartbeats and arrhythmias,
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`including atrial fibrillation and supraventricular tachycardia, are associated with
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`significant morbidity and mortality in patients. Ex. 1001 at 1:17-18; Ex. 2001 at
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`37. Arrythmias may occur continuously and intermittently, and a particularly
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`difficult type of arrhythmia to diagnose is intermittent arrhythmia. Id. at 1:19-20,
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`49-53; Ex. 2001 at 38. In order to accurately diagnose intermittent arrhythmia, the
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`diagnostic technique utilized cannot be applied at any time, but must be applied at
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`a time when the individual is experiencing an arrhythmia. Id. at 1:34-49; Ex. 2001
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`at 38. This diagnostic difficulty is often compounded because a patient may not be
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`aware that he or she is experiencing an intermittent arrhythmia. Id. at 1:53-57; Ex.
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`2001 at 38. Thus, in order to capture an intermittent arrhythmia, continuous
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`monitoring has generally been required. Id. at 4:15-20; Ex. 2001 at 39.
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`Historically, continuous measurements in an ambulatory patient has required
`
`recording ECG measurement through the use of a bulky and cumbersome holter
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`monitoring devices. Id. at 4:17-20; 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 41-42; Ex. 2002. As a result, it is difficult to obtain
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`a clean signal and extract HR from contaminated PPG. Id. Therefore, increasing
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`the 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 ‘941 Patent explains the state of the art in arrhythmia detection, the
`
`limitations in known techniques and equipment, and the need for the inventors’
`
`improvement in detection techniques and equipment. Ex. 1001 at 1:17-2:9, 3:63-
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`4:33.
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`C.
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`Specification
`
`The ’941 patent teaches systems and methods that allow for the convenient
`
`sensing of the presence of an intermittent arrhythmia in an individual. Ex. 1001 at
`
`1:26-2:3, 3:59-62. The ’941 patent generally relates to the method and devices
`
`AliveCor invented that enabled a user to wear a smartwatch equipped with sensors
`
`that would monitor a user’s heart, activity, and allow the user to record an ECG.
`
`See, e.g. id. at 2:10-3:12, 5:33-51, 8:1-26, 9:52-10:38; 11:8-59; 12:41-65; 14:48-
`
`15:59. The ’941 patent envisioned comparing the data from the sensors to
`
`determine that a discordance was possibly occurring, and then to use the ECG
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`sensor to confirm the presence of an arrhythmia. Id. at 12:41-65, 14:48-15:59.
`
`The ‘941 patent explains that convenient parameter values may be
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`continuously sensed, including heart rate and activity level. Id. at 1:58-61. The
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`‘941 patent then discloses how to analyze those continuously-monitored values to
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`determine the presence or future onset of an arrhythmia when there is discordance
`
`between those values. Id. at 1:61-2:3; 14:48-16:67. The patent also discloses that
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`an ECG may subsequently be taken to confirm the presence or absence of an
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`arrhythmia. See id. at 15:22-43.
`
`The claims of the ‘941 patent recite specific and novel implementations of
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`apparatus 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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`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 47. 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 diagnosis of potentially dangerous
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`arrhythmia conditions. Ex. 2001 at 48.
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`D.
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`Prosecution History
`
`During prosecution of U.S. Patent No. 9,839,363—which as noted above is
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`the grandparent to the ‘941 Patent—the examiner expressly found in an October
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`19, 2017 Notice of Allowance that the “inventive features” included monitoring a
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`subject’s heart rate and activity level, sensing a discordance between the heart rate
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`and activity level, and indicating to the subject to collect an electrocardiogram
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`using a wearable wristlet or smartwatch when a discordance is sensed. Ex. 2010 at
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`8. The examiner also found that “the prior art of record does not teach or suggest
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`the specific discordance monitoring as recited in the pending claims, and the prior
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`art of record does not teach or disclose indicating to the subject to collect an
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`electrocardiogram using the smartwatch when a discordance is sensed.” Id.
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`The application underlying the ‘941 Patent was filed a year later, on
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`October 11, 2018. Ex. 1002 at 224-273.
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`In response to a rejection by the examiner, the applicant argued that the cited
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`prior art did not “describe any specifics with respect to how data from two sensors
`
`may be combined to determine any metrics in particular” and did not “describe
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`how activity data and hear[t] rate data may be analyzed in combination to
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`determine a discordance.” Ex. 1002 at 114. The applicant further argued that the
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`prior art “does not describe taking an ECG to conf[i]rm the possibility of an
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`arrhythmia detected based on a discordance.” Id. at 116. Following the applicant’s
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`remarks, the examiner found the applicant’s arguments traversing the examiner’s
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`rejections to be “persuasive” and withdrew the corresponding rejections. Id. at 80.
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`The claims were allowed on March 3, 2020 without further comment after a
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`terminal disclaimer was filed. Id. at 28, 48-49.
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`III. LEVEL OF ORDINARY SKILL IN THE ART
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`Apple and Dr. Chaitman are incorrect that a POSITA in this field would
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`only need “a combination of Bachelor’s Degree (or a similar Master’s Degree, or
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`higher degree) in an academic area emphasizing health science, or a related field,
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`and two or more years of work experience with cardiac monitoring technologies
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`(e.g., a cardiologist).” Ex. 1003, ¶10; see also Petition at 10. It is insufficient that a
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`POSITA working in the field of the ‘941 Patent be defined in the general field of
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`“health science.” Ex. 2001 at 49-50.
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`The Summary of the Invention for the ‘941 Patent includes “systems,
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`devices, and methods for cardiac monitoring” and the use of “portable computing
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`devices” that are specifically configured to “predict or identify the occurrence of
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`arrhythmias.” Ex. 1001 at 1:26-33. A POSITA would need to understand the
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`specific aspects of the design, configuration, and operation of these devices, which
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`requires specialized engineering skills that a cardiologist may or may not possess
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`in his or her background. Ex. 2001 at 51-52. As a result, a degree in biomedical or
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`electrical engineering (or an equivalent), and/or extensive experience working with
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`tools for detecting cardiac conditions, including arrhythmias, would be necessary.
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`Ex. 2001 at 53. Indeed, the primary definition of a POSITA that Apple has
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`advanced in the parallel ITC action recognizes the need for exactly this type of
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`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
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`biomedical
`engineering,
`engineering, mechanical
`electrical
`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. . . .
`Notably, the definition for a PHOSITA would remain the same through
`May 2015, the priority date of the ’941 patent.
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`Ex. 2004 at 6.
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`Apple’s alternative POSITA definition proposed to this body does not
`
`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 at 5. 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. at 5-6
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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 ‘941 patent.
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`Ex. 2001 at 54-55.
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`IPR 2021-00972
`Patent Owner’s Preliminary Response
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`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 ‘941 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 ‘941 Patent itself. Ex. 2001 at 56. “[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
`
`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
`
`issue”). Dr. Chaitman’s testimony and opinions regarding the obviousness of the
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`‘941 Patent should therefore be accorded little weight by the Board in deciding
`
`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
`
`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 58.
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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 wi