throbber
CONTAINS CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`CONTAINS SOURCE CODE – ATTORNEYS’ EYES ONLY INFORMATION
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Cameron R. Elliot
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH EGG
`FUNCTIONALITY AND
`COMPONENTS THEREOF
`
`Inv. No. 337-TA-1266
`
`COMPLAINANT ALIVECOR, INC.’S INITIAL POST-HEARING BRIEF
`
`APPLE 1070
`Apple v. AliveCor
`IPR2021-00970
`
`1
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
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`
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`Table of Contents
`
`I.
`
`Introduction ..................................................................................................................... - 1 -
`
`A.
`
`B.
`
`C.
`
`D.
`
`Procedural History ............................................................................................... - 3 -
`
`The Parties ........................................................................................................... - 3 -
`
`1.
`
`2.
`
`Complainant AliveCor ............................................................................. - 3 -
`
`Respondent Apple.................................................................................... - 5 -
`
`Overview of the Technology ................................................................................ - 5 -
`
`The Patents at Issue ............................................................................................. - 6 -
`
`1.
`
`2.
`
`3.
`
`The ‘941 Patent ........................................................................................ - 6 -
`
`The ‘731 Patent ........................................................................................ - 6 -
`
`The ‘499 Patent ........................................................................................ - 7 -
`
`E.
`
`The Products at Issue ........................................................................................... - 7 -
`
`1.
`
`2.
`
`Apple Products ........................................................................................ - 7 -
`
`AliveCor Products .................................................................................. - 15 -
`
`II.
`
`Jurisdiction ..................................................................................................................... - 20 -
`
`III.
`
`Legal Standards .............................................................................................................. - 21 -
`
`A.
`
`B.
`
`C.
`
`Infringement ...................................................................................................... - 21 -
`
`Validity ............................................................................................................... - 21 -
`
`Domestic Industry ............................................................................................. - 22 -
`
`IV.
`
`The ‘941 Patent .............................................................................................................. - 23 -
`
`A.
`
`Claim Construction ............................................................................................ - 23 -
`
`1.
`
`2.
`
`The Preamble of the ‘941 Patent is Limiting ........................................... - 23 -
`
`“Confirm the Presence of the Arrhythmia” ............................................ - 24 -
`
`B.
`
`The Asserted Claims ....................................................................................... - 29 -
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`C.
`
`Apple Infringes the Asserted Claims of the ‘941 Patent ............................... - 30 -
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`1.
`
`
`
`
`
`D.
`
`Claim 12 ................................................................................................ - 30 -
`
`Claim 13 – Uncontested by Apple ............................................................... - 42 -
`
`Claim 19 – Uncontested by Apple ............................................................... - 42 -
`
`Claim 20 – Uncontested by Apple ............................................................... - 42 -
`
`Claim 21 – Uncontested by Apple ............................................................... - 43 -
`
`Claim 22 – Uncontested by Apple ............................................................... - 43 -
`
`Claim 23 – Uncontested by Apple ............................................................... - 43 -
`
`
` ............................................................................................................... - 43 -
`
`
`
`
`
` -
`
`E.
`
`The Asserted Claims of the ‘941 Patent are Valid ............................................... - 59 -
`
`1.
`
`2.
`
`The Asserted Claims Claim Patent-Eligible Subject Matter ..................... - 59 -
`
`The Asserted Claims Are Not Obvious in Light of AMON, Almen,
`and/or Kotzin ........................................................................................ - 69 -
`
`V.
`
`The ‘731 Patent .............................................................................................................. - 87 -
`
`1.
`
`2.
`
`The Preamble of the ‘731 Patent is Not Limiting ................................... - 87 -
`
`“Confirm the Presence of the Arrythmia” ......................................... - 88 -
`
`B.
`
`C.
`
`The Asserted Claims ....................................................................................... - 88 -
`
`Apple Infringes the Asserted Claims of the ‘731 Patent ............................... - 89 -
`
`1.
`
`2.
`
`3.
`
`4.
`
`Claim 1 .................................................................................................. - 89 -
`
`Claim 3 – Uncontested by Apple ................................................................. - 92 -
`
`Claim 5 – Uncontested by Apple ................................................................. - 93 -
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`Claim 8 – Uncontested by Apple ................................................................. - 93 -
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`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Claim 9 – Uncontested by Apple ................................................................. - 93 -
`
`Claim 10 – Uncontested by Apple ............................................................... - 93 -
`
`Claim 12 – Uncontested by Apple ............................................................... - 94 -
`
`Claim 15 – Uncontested by Apple ............................................................... - 94 -
`
`Claim 16 – Uncontested by Apple ............................................................... - 94 -
`
`D.
`
`AliveCor’s Domestic Industry Products Practice Certain of the Asserted
`Claims of the ’731 Patent ................................................................................. - 95 -
`
`1.
`
`
`
`
`
`
`
`
`
`
`
`E.
`
`The Asserted Claims of the ‘731 Patent are Valid ............................................. - 108 -
`
`1.
`
`2.
`
`The Asserted Claims Claim Patent-Eligible Subject Matter ................... - 108 -
`
`The Asserted Claims Are Not Obvious in Light of AMON, Almen,
`and/or Kotzin ...................................................................................... - 114 -
`
`VI.
`
`The ‘499 Patent ............................................................................................................ - 122 -
`
`A.
`
`B.
`
`The Asserted Claims ..................................................................................... - 122 -
`
`Apple Infringes the Asserted Claims of the ‘499 Patent ............................. - 122 -
`
`1.
`
`2.
`
`Claim 16 – Uncontested by Apple .................................................... - 123 -
`
`Claim 17 – Uncontested by Apple ............................................................. - 133 -
`
`D.
`
`AliveCor’s Domestic Industry Products Practice Certain of the Asserted
`Claims of the ’499 Patent .............................................................................. - 134 -
`
`1.
`
`
`
`
`
`
`
`E.
`
`The Asserted Claims of the ‘499 Patent are Valid ............................................. - 142 -
`
`1.
`
`The Asserted Claims Claim Patent-Eligible Subject Matter ................... - 142 -
`
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`2.
`
`The Asserted Claims Are Not Obvious in Light of AMON, Almen,
`and/or Kotzin ...................................................................................... - 144 -
`
`VII. Economic Prong of the Domestic Industry REquirement ............................................ - 146 -
`
`A.
`
`AliveCor Has an Ongoing Domestic Industry in the
`
` .. - 149 -
`
`1.
`
`2.
`
`3.
`
`4.
`
`Apple’s Arguments Ignore AliveCor’s Continuing Investments ........... - 150 -
`
`Investment in Plant and Equipment Under § 1337(a)(3)(A) .................. - 153 -
`
`Investment in Employment of Labor or Capital Under § 1337(a)(3)(B) - 158 -
`
`Exploitation of Asserted Patents Under § 1337(a)(3)(C) ....................... - 161 -
`
`B.
`
`Alternatively, a Domestic Industry Is in the Process of Being Established........ - 164 -
`
`1.
`
`2.
`
`3.
`
`Investment in Plant and Equipment Under § 1337(a)(3)(A) .................. - 167 -
`
`Investment in Employment of Labor or Capital Under § 1337(a)(3)(B) - 168 -
`
`Exploitation of Asserted Patents Under § 1337(a)(3)(C) ....................... - 169 -
`
`C.
`
`Apple Did Not Rebut AliveCor’s Evidence of Significant and Substantial
`Investments ..................................................................................................... - 169 -
`
`VIII. Remedy and Bond ........................................................................................................ - 171 -
`
`A.
`
`B.
`
`C.
`
`D.
`
`Limited Exclusion Order .................................................................................. - 171 -
`
`Cease and Desist Order .................................................................................... - 172 -
`
`Bond ................................................................................................................ - 173 -
`
`Enforcement .................................................................................................... - 174 -
`
`VII. Conclusion ................................................................................................................... - 175 -
`
`
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`TABLE OF AUTHORITIES
`
`Cases
`
`Alloc, Inc. v. lntl’l Trade Comm’n,
` 342 F.3d 1361 (Fed. Cir. 2003) ................................................................................................................. 22
`Amgen Inc. v. Hoechst Marion Roussel, Inc.,
` 314 F.3d 1313 (Fed. Cir. 2003) ................................................................................................................. 29
`Apple Inc. v. Samsung Elecs. Co.,
` 839 F.3d 1034 (Fed. Cir. 2016) .......................................................................................................... 81, 82
`Bascom Glob. Internet Servs., Inc. v. AT&T Mobility LLC,
` 827 F.3d 1341 (Fed. Cir. 2016) .............................................................................................................. 112
`Brilliant Insts., Inc. v. Guidetech, LLC,
` 707 F.3d 1342 (Fed. Cir. 2013) ................................................................................................................. 21
`C.R. Bard, Inc. v. U.S. Surgical Corp.,
` 388 F.3d 858 (Fed. Cir. 2004) ................................................................................................................... 28
`CardioNet, LLC v. InfoBionic, Inc.,
` 955 F.3d 1358 (Fed. Cir. 2020) ........................................................................................................ 61, 109
`Carroll Touch, Inc. v. Electro Mechanical Sys., Inc.,
` 15 F.3d 1573 (Fed. Cir. 1993) ................................................................................................................... 21
`Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc.,
` 289 F.3d 801 (Fed. Cir. 2002) ............................................................................................................ 23, 24
`Crown Packaging Tech., Inc. v. Rexam Beverage Can Co.,
` 559 F.3d 1308 (Fed. Cir. 2009) ................................................................................................................. 21
`In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Pat. Litig.,
` 676 F.3d 1063 (Fed. Cir. 2012) ................................................................................................................. 74
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH,
` 8 F.4th 1331 (Fed. Cir. 2021) ................................................................................................................. 145
`Exergen Corporation v. Kaz USA, Inc.,
` 725 F. App’x 959 (Fed. Cir. 2018) ............................................................................. 66, 67, 69, 112, 113
`Finjan, Inc. v. Secure Computing Corp.,
` 626 F.3d 1197 (Fed. Cir. 2010) ............................................................................................. 48, 53, 57, 97
`Fox Factory, Inc. v. SRAM, LLC,
` 944 F.3d 1366 (Fed. Cir. 2019) ................................................................................................................. 87
`Helmsderfer v. Bobrick Washroom Equip., Inc.,
` 527 F.3d 1379 (Fed. Cir. 2008) ................................................................................................................. 28
`McRO, Inc. v. Bandai Namco Games Am. Inc.,
` 837 F.3d 1299 (Fed. Cir. 2016) ........................................................................................................ 64, 110
`Motorola Mobility, LLC v. Int’l Trade Comm’n,
` 737 F.3d 1345 (Fed. Cir. 2013) ............................................................................................. 146, 149, 163
`
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`P’ship v. Microsoft Corp.,
` 598 F.3d 831 (Fed. Cir. 2010) ................................................................................................................... 22
`PharmaStem Therapeutics, Inc. v. ViaCell, Inc.,
` 491 F.3d 1342 (Fed. Cir. 2007) ................................................................................................................. 22
`Phillips v. AWH Corp.,
` 415 F.3d 1303 (Fed. Cir. 2005) .......................................................................................................... 26, 28
`Proctor & Gamble Co. v. Teva Pharms. USA, Inc.,
` 566 F.3d 989 (Fed. Cir. 2009) ................................................................................................................... 70
`Raytheon Techs. Corp. v. Gen. Elec. Co.,
` 993 F.3d 1372 (Fed. Cir. 2021) ................................................................................................................. 74
`Rowe v. Dror,
` 112 F.3d 473 (Fed. Cir. 1997) ................................................................................................................... 88
`Santarus, Inc. v. Par Pharm., Inc.,
` 694 F.3d 1344 (Fed. Cir. 2012) ................................................................................................................. 72
`Spansion, Inc. v. Int’l Trade Comm’n,
` 629 F.3d 1331 (Fed. Cir. 2010) ................................................................................................................. 21
`Certain Integrated Circuit Chips and Products Containing the Same,
` Inv. No. 337-TA-859, Comm’n Op. (Aug. 22, 2014) ........................................................................... 162
`Certain Agric. Vehicles and Components Thereof,
` Inv. No. 337-TA-487, Initial Determination at 76 (Jan. 13, 2004) ............................................ 23, 173
`Certain Automated Teller Machines,
` Inv. No. 337-TA-972, Comm’n Op. (May 19, 2017) ............................................................................ 171
`Certain Beverage Brewing Capsules, Components Thereof, and Products Containing the Same,
` Inv. No. 337-TA-929, Order No. 21 n.2 (May 18, 2015) .................................................... 45, 149, 163
`Certain Ceramic Capacitors and Products Containing Same,
` Inv. No. 337-TA-692, ID (December 22, 2010) ................................................................................ 149
`Certain Electronic Digital Media Devices and Components Thereof,
` Inv. No. 337-TA-796, Comm’n Op. (Sept. 6, 2013) .......................................................................... 163
`Certain Electronic Digital Media Devices and Components Thereof,
` Inv. No. 337-TA-796, Initial Determination (Sept. 14, 2012) .......................................................... 162
`Certain Ink Jet Print Cartridges & Components Thereof,
` Inv. No. 337-TA-446, Comm’n Op., 2002 WL 31464980 (May 8, 2002) ......................................... 22
`Certain Light-Emitting Diode Products, Fixtures, and Components Thereof,
` 337-TA-1213, Comm’n Op., (Jan. 14, 2022) ....................................................................................... 172
`Certain Light-Emitting Diode Products, Systems, and Components Thereof (III),
` Inv. No. 337-TA-1168, Initial Determination (June 26, 2020) ............................................... 20, 22, 71
`Certain Liquid Crystal Display Devices & Prod. Containing the Same,
` Inv. No. 337-TA-631, Order No. 18, 2008 WL 4682826 (Sept. 23, 2008) ..................................... 157
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`Certain Loom Kits for Creating Linked Articles,
` 337-TA-923, Comm’n Op. (June 26, 2015) ......................................................................................... 148
`Certain Magnetic Tape Cartridges and Components Thereof,
` Inv. No. 337-TA-1058, Initial Determination (Aug. 17, 2018) .................................................... 21, 22
`Certain Magnetic Tape Cartridges and Components Thereof,
` Inv. No. 337-TA-1058, Comm’n Op. (April 9, 2019) .............................................................................. 45
`Certain Male Prophylactic Devices,
` Inv. No. 337-TA-546, Comm’n Op. (Aug. 1, 2007) .............................................................................. 153
`Certain Marine Sonar Imaging Devices,
` Inv. No. 337-TA-921, Comm’n Op. (Jan. 6, 2016) ............................................................................ 148
`Certain Microsphere Adhesives, Process for Making Same, and Products Containing Same, Including Self-
`Stick Repositionable Notes,
` Inv. No. 337-TA-366, Comm’n Op. (Jan. 16, 1996) ............................................................................. 173
`Certain Mobile Devices, Associated Software, & Components Thereof,
` Inv. No. 337-TA-744, Comm’n Op., 2012 WL 3715788 (June 5, 2012) ................................ 173, 174
`Certain Movable Barrier Operator Systems and Components Thereof,
` Inv. No. 337-TA-1118, Comm’n Op. (Jan. 12, 2021) ................................................................ 149, 161
`Certain Non-Volatile Memory Devices,
` Inv. No. 337-TA-1046, Comm’n Op. (Oct. 26, 2018) ......................................................... 51, 148, 162
`Certain Road Construction Machines and Components Thereof,
` lnv. No. 337-TA-1088 (February 14, 2019) ......................................................................................... 157
`Certain Road Milling Machines and Components Thereof,
` Order No. 23, Inv. No. 337-TA-1067 (Feb. 15, 2018) ......................................................................... 21
`Certain Semiconductor Chips with Minimized Chip Package Size and Products Containing Same,
` Inv. No. 337-TA-432, Recommended Determination (Oct. 1, 2001) ............................................. 173
`Certain Semiconductor Integrated Circuits & Prods. Containing Same,
` Inv. No. 337-TA-665, Initial Determination at 231 (Oct. 14, 2009) .................................................. 23
`Certain Solid State Storage Drives,
` Inv. No. 337-TA-1097, Comm’n Op. (June 29, 2018) .......................................................................... 161
`Certain Stringed Musical Instruments and Components Thereof,
` Inv. No. 337-TA-586, Comm’n Op. (May 16, 2008) ................................................................. 155, 164
`Certain Television Sets, Television Receivers, Television Tuners, and Components Thereof,
` Inv. No. 337-TA-910, Comm’n Op. (Oct. 30, 2015) ......................................................................... 160
`Certain Thermoplastic-Encapsulated Electric Motors,
` Inv. No. 337-TA-1073, Comm’n Op. (Aug. 12, 2019) ...................................................................... 165
`Certain Video Game Systems and Controllers,
` Inv. No. 337-TA-743, Comm. Op. (Jan. 20, 2012) ............................................................................ 157
`
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`Statutory Authorities
`
`19 U.S.C. § 1337 ......................................................................................................................................... passim
`35 U.S.C. § 101 ................................................................................................................................ 65, 111, 143
`35 U.S.C. § 103 ................................................................................................................................................. 22
`35 U.S.C. § 271 ................................................................................................................................................. 21
`35 U.S.C. § 282 ................................................................................................................................................. 22
`
`Additional Authorities
`
`MPEP § 2158 .................................................................................................................................................... 74
`
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`I.
`
`INTRODUCTION
`
`For years, Complainant AliveCor, Inc. has pioneered clinically validated cardiac monitoring
`
`technology packaged in portable, easy-to-use devices. The inventions at issue in this investigation
`
`harnessed unconventional techniques and configurations of sensors to more accurately detect
`
`arrhythmias in ambulatory users. The asserted patent claims that cover this breakthrough technology
`
`recite patent-eligible subject matter and are non-obvious.
`
`In 2017, AliveCor commercialized the technology in the Asserted Patents by releasing the
`
`KardiaBand System (“KBS”), which was the first FDA-cleared medical device accessory for the Apple
`
`Watch. AliveCor also released SmartRhythm, a machine learning algorithm that could monitor a user’s
`
`heart rate for irregular rhythms to determine when a user was experiencing an episode of arrhythmia,
`
`such as atrial fibrillation. When a user was experiencing an abnormal rhythm, SmartRhythm would
`
`notify the user to record an electrocardiogram (“ECG”) by touching a sensor on the KardiaBand to
`
`confirm that the user had an arrhythmia.
`
`Recognizing the benefits of AliveCor’s technology, Apple first considered whether to acquire
`
`AliveCor, but later determined that KBS posed a competitive threat to its plans for the Apple Watch.
`
`In 2016, before KBS was launched, Jeff Williams emailed Apple’s CEO about AliveCor and wrote
`
`that he “thought about acquisition” of AliveCor. CX-0911C. The acquisition never happened; instead,
`
`Apple took active steps to compete with AliveCor and slow down the adoption of KBS. When Mike
`
`O’Reilly of Apple learned that AliveCor wanted to market KBS for use with Apple Watches, he wrote
`
`to Mr. Williams, “[g]iven our plans for antimony [code name for Apple’s IRN feature], do we want to
`
`discourage them from carrying that product? … I don’t see a downside, unless we’ll appear
`
`disingenuous by allowing them to carry a product we know we’ll likely replace.” CX-0910C
`
`(bracketed clarification and emphasis added). By mid-2017, Apple had not yet to marketed an ECG-
`
`capable watch of its own, but it learned that AliveCor was testing KBS in clinical trials. CX-0909C. In
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`response, Myoung Cha of Apple observed, “I view AliveCor as somewhat competitive to what we
`
`are ultimately aiming to do ….” Id. (emphasis added). And Mike O’Reilly responded that KBS “could
`
`be a driver for [AliveCor’s] service.” Id. In February 2018, Christopher Tan of Apple received an email
`
`about KBS from Rich Taggart, another Apple employee. RX-0789C. Mr. Taggart wrote, “With a few
`
`small tweaks this could be a great experience for Apple Watch customers.” Id. Mr. Tan agreed that the
`
`KBS “is a high quality accessory and works really well with the Watch.” Id.
`
`After declining to acquire AliveCor, Apple finally released its ECG app and IRN feature on
`
`December 6, 2018. RX-0047. At the same time, Apple modified the PPG “data underlying the
`
`WatchOS system.” Tr. (Somayajula) at 199:18-200:20. As a result, “SmartRhythm broke.” Id. And
`
`Apple followed up by demanding that AliveCor stop asking KBS users to keep their watch running in
`
`workout mode. Tr. (Albert) at 83:20-84:9. At the hearing, Apple claimed this was due to the battery
`
`drain from running workout mode. Tr. (Albert) at 141:11-15. But Dr. Waydo—Apple’s sole fact
`
`witness, and one of the Apple employees who “tr[ied] out the KardiaBand product”—was not aware
`
`of a single “stud[y] … done by Apple to assess the battery impact of using KardiaBand in workout
`
`mode.” Tr. (Waydo) at 821:22-822:18. In fact, Dr. Waydo was told by his colleague that “leaving the
`
`watch on workout mode all day still leaves [him] with 40 percent battery at the end of day.” Id.; RX-
`
`0790C. They specifically considered the battery life issue when trying out KBS and found no issue.
`
`But Apple nonetheless informed AliveCor that it could not tell customers to leave their watches in
`
`workout mode even with their informed consent—as was needed to run SmartRhythm, a critical
`
`component of KBS covered by the Asserted Patents.
`
`Apple is now trying to wring one more benefit out of its unfair competition. It argues in this
`
`Investigation that AliveCor cannot satisfy the domestic industry requirement because “[t]he
`
`KardiaBand System has been discontinued since 2019, and AliveCor did not have any qualifying
`
`activities under Section 1337(a)(3) that would allow it to capture its past expenditures relating to the
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`KardiaBand System to satisfy the domestic industry requirement.” Apple PreHB at 154-55. Crediting
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`this argument would mean that a respondent can immunize itself from a patent-based exclusion order
`
`by destroying the domestic industry of a complainant through other unfair acts. That would be
`
`contrary to the very purpose and mission of the ITC, which is to protect domestic industry in patented
`
`technologies and promote innovations.
`
`The argument also runs contrary to the evidentiary record, which shows that AliveCor has
`
`continuously engaged in qualifying activities under Section 1337(a)(3) by building on the innovations
`
`first achieved through KBS. When Apple took AliveCor’s patented technology without permission
`
`and then took steps to break SmartRhythm, AliveCor kept investing and has developed additional
`
`form factors to bring its patented technology to consumers and clinicians. Its domestic investments
`
`in developing and supporting the DI Products are significant and substantial. At the hearing, AliveCor
`
`proved that Apple violated Section 337 and that an exclusion order is warranted to protect AliveCor’s
`
`intellectual property and its DI Products.
`
`A.
`
`Procedural History
`
`On April 20, 2021, AliveCor filed a complaint under Section 337 of the Tariff Act of 1930,
`
`as amended, 19 U.S.C. § 1337, based on the unlawful importation, sale for importation, and/or sale
`
`within the United States after importation by Apple of certain wearable electronic devices with ECG
`
`capability and components thereof that infringe one or more claims of U.S Patent Nos. 10,638,941,
`
`10,595,731, and 9,572,499, either literally or under the doctrine of equivalents. EDIS No. 740438.
`
`AliveCor filed an amended complaint on April 26, 2021. EDIS No. 740951. The Commission
`
`instituted this investigation on May 20, 2021. EDIS No. 743034. The target date is October 26,
`
`2022. EDIS No. 744439.
`
`B.
`
`The Parties
`
`1.
`
`Complainant AliveCor
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`- 3 -
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`12
`
`

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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`CONTAINS SOURCE CODE – ATTORNEYS’ EYES ONLY INFORMATION
`
`AliveCor is a corporation organized and existing pursuant to the laws of the State of
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`Delaware and has its principal place of business at 189 N Bernardo Ave Suite 100, Mountain View,
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`CA 94043.1 AliveCor is a leader in the design and development of products that provide intelligent,
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`highly personalized heart data to help diagnose heart conditions.
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`AliveCor was founded in 2011 by Dr. David Albert, Bruce Satchwell, and Kim Barnett. The
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`founders worked together to address the leading cause of death in the United States: heart disease.
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`Their idea was to give patients the ability to monitor heart health with an accurate and easy to use
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`device that allowed individuals to take their own ECG. AliveCor’s first product was an ECG device
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`that could work with an iPhone. In 2010, the founders developed an iPhone 4 case with two
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`electrodes built into the back of the case that, when held in a user’s hands or pressed against the
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`user’s chest, took an ECG reading and then communicated its findings to an iPhone 4. Tr. (Albert)
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`at 56:7-10. The operation of that first ECG iPhone case was demonstrated in a YouTube video and
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`presented at the 2011 consumer electronics show. Id. at 56: 11-17; CDX-005.15.
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`Shortly after the 2011 Consumer Electronics Show, the founders officially formed AliveCor
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`to bring their novel ECG device to market. In 2017, AliveCor was first to bring to market an FDA-
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`cleared wearable consumer device, the KardiaBand, which monitored the owner’s heart, detected
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`heart rate irregularities, and then allowed the owner to perform an ECG to confirm the presence of
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`atrial fibrillation (“AFib”). Tr. (Albert) at 56:7-10; CX-0483C. In doing so, AliveCor became the first
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`company to receive FDA clearance for a nonprescription wearable medical device that allowed a
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`consumer to record ECG measurements and analyze such measurements on the device in real-time
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`using machine learning algorithms. Since introducing KardiaBand, AliveCor has devoted significant
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`resources to bringing additional consumer ECG devices to market.
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`1 When the Complaint was filed, AliveCor was located at 444 Castro St, Suite 600, Mountain View,
`CA 94041.
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`
`
`- 4 -
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`13
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`

`

`CONTAINS CONFIDENTIAL BUSINESS INFORMATION SUBJECT TO PROTECTIVE ORDER
`CONTAINS SOURCE CODE – ATTORNEYS’ EYES ONLY INFORMATION
`
`2.
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`Respondent Apple
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`Apple is a California corporation with a principal place of business at One Apple Park Way,
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`Cupertino, California 95014. Apple designs, develops, tests, imports into the United States, offers
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`for sale, and sells in the United States after importation infringing wearable electronic devices,
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`including those sold under the tradenames Apple Watch Series 4, Apple Watch Series 5, Apple
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`Watch Series 6, and Apple Watch Series 7. There are past and current versions of Apple Watches
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`that do not contain an ECG sensor, which are not accused in this investigation.
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`C.
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`Overview of the Technology
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`Atrial Fibrillation (“AFib”) is one type of heart disease. AFib is a qui

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