1300 I Street NW, Suite 900, Washington, District of Columbia 20005-3314 I TEL (202) 538-8000 FAX (202) 538-8100
`
`WRITER'S DIRECT DIAL No.
`
`(202) 538-8104
`
`WRITER'S EMAIL ADDRESS
`
`alexlasher@quinnemanuel.com
`
`April 20, 2021
`
`FILED VIA EDIS
`
`The Honorable Lisa R. Barton
`
`Secretary
`US. International Trade Commission
`
`500 E Street, SW, Room 112A
`Washington, DC 20436
`
`Re:
`
`Certain Wearable Electronic Devices With ECG Capability and Components Thereof
`
`Dear Secretary Barton:
`
`Enclosed for filing, please find documents in support of a request by AliveCor, Inc.
`(“Complainant”) that the US. International Trade Commission institute an investigation pursuant
`to Section 337 of the Tariff Act of 1930, as amended, concerning certain wearable electronic
`devices with electrocardiogram (“ECG”) capability and components thereof. There is no
`confidential business information contained in the complaint itself, but we have included a
`separate letter requesting confidential treatment for five exhibits included with this filing.
`
`On March 16, 2020, the Commission provided “notice that it is temporarily waiving and
`amending certain of the Commission’s rules that required the filing of paper copies, CD-ROMS,
`and other physical media in section 337 investigations to address concerns about COVID-19.”
`International Trade Commission, Temporary Changes to Filing Procedures, Federal Register
`Vol. 85, No. 54 (March 19, 2020). Specifically, the Commission approved the temporary
`amendment of various rules “to permit parties to file section 337 complaints, exhibits,
`attachments, and appendices, electronically.” Id. Accordingly, Complainant’s filing only
`contains electronic documents.
`
`Complainant’s submission via EDIS includes the following:
`
`1.
`
`2.
`
`One (1) electronic copy of Complainant's Verified Complaint, pursuant to
`Commission Rule 210.8(a)(1)(i).
`
`One (1) electronic copy of the public exhibits to the Verified Complaint pursuant
`to Commission Rules 210.8(a)(1)(1) and 210.12(a)(9), including:
`
`llllillll emanuel llfllllllafl 8. sullivan, IIII
`AUSTIN BOSTON BRUSSELS CHICAGO HAMBURG I HONG KONG I HOUSTON I LONDON LOS ANGELES I MANNI-IEIM I MUNICH
`NEUILLY—LA DEFENSE I NEW YORK I PARIS I l’ERTlI I SALT LAKE CITY SAN FRANCISCO I SEATTLE SIIANGIIAI I SILICON VALLEYI
`STUTTGART SYDNEY I TOKYO I WASHINGTON, DC ZURICII
`
`

`

`a.
`
`b.
`
`one (1) electronic certified copy of each of United States Patent Nos.
`10,595,731 (“the ’731 patent”), 10,638,941 (“the ’941 patent”), and
`9,572,499 (“the ’499 patent”), copies of which are respectively included as
`Exhibits 1, 2, and 3, to the Verified Complaint pursuant to Commission
`Rule 210.12(a)(9)(l); and
`
`one (1) electronic copy of the certified assignment records for each of the
`’731 patent, ’941 patent, and ’499 patent, copies of which are respectively
`included as Exhibits 4, 5, and 6 to the Verified Complaint, pursuant to
`Commission Rule 210. 12(a)(9)(ii).
`
`One (1) electronic copy of the confidential exhibits to the Verified Complaint,
`pursuant to Commission Rules 201 .6(c) and 210.8(a)(1)(ii).
`
`Four (4) electronic copies of the certified prosecution history of the ’941 patent
`which is identified as Appendix C to the Verified Complaint, pursuant to
`Commission Rule 210.12(c)(1). Four (4) electronic copies of the prosecution
`history of the ’731 patent and ’499 patent, which are respectively identified as
`Appendices A and E to the Verified Complaint.1
`
`Four (4) electronic copies each of each patent and applicable pages of each
`technical reference mentioned in the prosecution history of ’731 patent, ’941
`patent, and ’499 patent, which are respectively identified as Appendices B, D, and
`F to the Verified Complaint, pursuant to Commission Rule 210.12(c)(2).
`
`A letter and certification requesting confidential treatment for the information
`contained in confidential exhibits 8 and 16-22 to the Verified Complaint, pursuant
`to Commission Rules 201.6(b) and 210.5(d).
`
`A Statement on the Public Interest regarding the remedial orders sought by
`Complainants in the Verified Complaint, pursuant to Commission Rule 210.8(b).
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Complainant confirms that it will serve copies of the non-confidential versions of the
`Complaint and all associated exhibits and appendices upon the institution of this investigation on
`the Respondent consistent with 19 C.F.R. part 201 (including 19 C.F.R. § 201.16) and the
`Temporary Procedures.
`
`Please contact me with any questions regarding this filing.
`
`1 Certified copies of the prosecution history for the ’499 and ’731 patents have been ordered
`and will be provided once they are received from the U.S.P.T.O.
`
`

`

`Respectfully submitted
`
`
`/S/ S. Alex Lasher
`
`S. Alex Lasher
`
`Counselfor Complainant AliveCor, Inc.
`
`

`

`1300 I Street NW, Suite 900, Washington, District of Columbia 20005-3314 I TEL (202) 538-8000 FAX (202) 538-8100
`
`WRITER'S DIRECT DIAL N0.
`
`(202) 538-8104
`
`WRITER'S EMAIL ADDRESS
`
`alexlasher@quinnemanuel.com
`
`REQUEST FOR CONFIDENTIAL TREATMENT
`
`April 20, 2021
`
`FILED VIA EDIS
`
`The Honorable Lisa R. Barton
`
`Secretary
`US. International Trade Commission
`
`500 E Street, SW, Room 112A
`
`Washington, DC 20436
`
`Re:
`
`Certain Wearable Electronic Devices With ECG Capability and Components Thereof
`
`Dear Secretary Barton:
`
`Pursuant to Commission Rule 201.6, Complainant AliveCor, Inc. (“Complainant” or
`“AliveCor”) respectfully requests confidential treatment of certain confidential business
`information contained in confidential exhibits 8 and 16-22 to the Verified Complaint.
`
`The information in the exhibits for which Complainant seeks confidential treatment
`consists of proprietary commercial information, including confidential and proprietary licensing
`information, technical information related to domestic articles protected by Complainant's
`asserted patents, technical information related to accused products articles obtained from
`nonpublic teardowns, and financial data regarding Complainant's domestic investments in plant
`and equipment and labor and capital related to domestic articles protected by Complainant‘s
`asserted patents.
`
`The proprietary information described herein qualifies as confidential business
`information under Commission Rule 201.6 because substantially-identical information is not
`available to the public, because the disclosure of this information would cause substantial
`competitive harm to Complainant, and because the disclosure of this information would likely
`impede the Commission's efforts and ability to obtain similar information in the future.
`
`Thank you for your attention. Please contact me with any questions regarding this request
`for confidential treatment.
`
`llllillll emanuel llfllllllafl 8. sullivan, IIII
`AUSTIN BOSTON BRUSSELS CHICAGO HAMBURG I HONG KONG I HOUSTON I LONDON LOS ANGELES I MANNI—IEIM I MUNICH
`NEUILLY—LA DEFENSE I NEW YORK I I’ARIS I l’ERTlI I SALT LAKE CITY SAN FRANCISCO I SEATTLE SIIANGIIAI I SILICON VALLEYI
`STUTTGART SYDNEY I TOKYO I WASHINGTON, DC ZURICII
`
`

`

`Respectfully submitted
`
`/S/ S. Alex Lasher
`
`S. Alex Lasher
`
`Counselfor ComplainantAlz'veCor, Inc.
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, D.C.
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`
`DEVICES WITH ECG
`
`FUNCTIONALITY AND COMPONENTS
`
`THEREOF
`
`
`Inv. N0. 337—TA—
`
`CERTIFICATION
`
`I, S. Alex Lasher, counsel for Complainant AliveCor, Inc., declare as follows:
`
`1.
`
`2.
`
`I am duly authorized by Complainant to execute this certification.
`
`I have reviewed confidential exhibits 8 and 16-22 to Complainant's Verified
`Complaint, for which Complainant seeks confidential treatment.
`
`Confidential Exhibit 8 is a list of private agreements between AliveCor and its
`licensees. Disclosure of this information to the public would cause substantial
`harm to AliveCor, their respective competitive positions, and their ability to
`negotiate future agreements. Disclosure of this information would also impair the
`Commission’s ability to obtain information necessary to perform its statutory
`function.
`
`Confidential Exhibit 16 contains confidential commercial and technical
`
`information concerning the development of domestic industry products, which is
`not available for public dissemination. Disclosure of this information to the public
`would cause substantial harm to AliveCor and its competitive position. Disclosure
`of this information also would impair the Commission’s ability to obtain
`information necessary to perform its statutory function.
`
`Confidential Exhibit 17 contains confidential commercial and technical
`
`information concerning the development of domestic industry products, which is
`not available for public dissemination. Disclosure of this information to the public
`would cause substantial harm to AliveCor and its competitive position. Disclosure
`of this information also would impair the Commission’s ability to obtain
`information necessary to perform its statutory function.
`
`Confidential Exhibit 18 contains confidential commercial and technical
`
`information concerning the development of domestic industry products, which is
`not available for public dissemination. Disclosure of this information to the public
`would cause substantial harm to AliveCor and its competitive position. Disclosure
`
`

`

`of this information also wouldimpair the Commission’s ability to obtain
`information necessary to perform its statutory function.
`
`7.
`
`Confidential Exhibit 19 contains confidential commercial and technical
`
`information concerning the development of domestic industry products, which is
`not available for public dissemination. Disclosure of this information to the public
`would cause substantial harm to AliveCor and its competitive position. Disclosure
`of this information also would impair the Commission’s ability to obtain
`information necessary to perform its statutory function.
`
`8.
`
`Confidential Exhibit 20 contains confidential commercial and financial
`
`information concerning AliveCor’s investments in its domestic industry, which is
`not available for public dissemination. Disclosure of this information to the public
`would cause substantial harm to LG and its competitive position. Disclosure of
`this information also would impair the Commission’s ability to obtain information
`necessary to perform its statutory function.
`
`9.
`
`Confidential Exhibit 21 contains confidential commercial and technical
`
`information concerning the development of domestic industry products, which is
`not available for public dissemination. Disclosure of this information to the public
`would cause substantial harm to AliveCor and its competitive position. Disclosure
`of this information also would impair the Commission’s ability to obtain
`information necessary to perform its statutory function.
`
`10.
`
`Confidential Exhibit 22 is a private license agreement to AliveCor’s patents that
`contains confidential information regarding the terms of the agreement and the
`circumstances that led to the agreement, which is not available for public
`dissemination. Disclosure of this information to the public would cause
`substantial harm to AliveCor and its licensee, their respective competitive
`positions, and their ability to negotiate future agreements. Disclosure of this
`information would also impair the Commission’s ability to obtain information
`necessary to perform its statutory function.
`
`3.
`
`To the best of my knowledge, information, and belief, founded after a reasonable
`inquiry, substantially-identical information to that contained in the exhibits is not
`available to the public.
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`Executed this 20th day of April, 2021 in Washington, DC.
`
`/s/ S. Alex Lasher
`
`S. Alex Lasher
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, D.C.
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`
`DEVICES WITH ECG
`
`FUNCTIONALITY AND
`
`COMPONENTS THEREOF
`
`
`
`Investigation No. 337—TA—
`
`COMPLAINANT’S STATEMENT ON THE PUBLIC INTEREST
`
`Pursuant to Commission Rule 210.8(b), Complainant AliveCor, Inc. (“AliveCor”) submits
`
`this Statement on the Public Interest regarding the remedial orders it seeks against Proposed
`
`Respondent Apple Inc. (“Apple”). AliveCor seeks a permanent limited exclusion order barring from
`
`entry into the United States certain wearable electronic devices with electrocardiogram (“ECG”)
`
`capability and components thereof that infringe one or more claims of United States Patent Nos.
`
`10,595,731, 10,638,941, and 9,572,499 (collectively, the “Asserted Patents”). AliveCor also seeks a
`
`permanent cease and desist order prohibiting Apple, its subsidiaries, related companies, and agents
`
`from engaging in the importation, sale for importation, marketing and/or advertising, distribution,
`
`offering for sale, sale, use after importation, sale after importation, or other transfer within the
`
`United States of the accused products.
`
`I.
`
`Introduction
`
`AliveCor is headquartered in Mountain View, California, and is a leader in the design and
`
`development of products that provide intelligent, highly-personalized heart data to help diagnose
`
`heart conditions. In 2017, capitalizing on development work performed by its founders and its team
`
`of Califomia-based engineers, AliveCor was first company to bring to market an FDA-cleared
`
`wearable consumer device capable ofmonitoring the owner’s heart rate, detecting episodes of atrial
`
`

`

`fibrillation (“AFib”), and then allowing the owner to perform an ECG. This revolutionary wearable
`
`device—the KardiaBand—embodies inventions protected by the patents AliveCor is asserting in its
`
`Complaint. After Apple anti-competitively and unfairly excluded KardiaBand from the market,
`
`AliveCor developed additional products that practice those patents. The remedies requested in
`
`AliveCor’ s complaint will enforce its intellectual property rights, protecting AliveCor’ s innovations
`
`and products. As the Commission has recognized, protecting such intellectual property rights is in
`
`the public interest. See, e.g., Certain Baseband Processor Chips and Chipsets, Transmitter and
`
`Receiver (Radio) Chips, Power Control Chips, and Products Containing Same, Including Cellular
`
`Telephone Handsets, Inv. No. 337-TA-543, Comm’n Op. at 136-37 (June 19, 2007).
`
`AliveCor’s requested remedies will not adversely affect “the public health and welfare,
`
`competitive conditions in the United States economy, the production of like or directly competitive
`
`articles in the United States, [or] United States consumers.” 19 U.S.C. § 1337(d)(l). Any demand
`
`for the products that would be subject to the requested remedial orders could be filled by the diverse
`
`field of suppliers offering smartwatches or wearable ECG devices to United States consumers. The
`
`availability of those products would prevent adverse effects on the public health and welfare. And
`
`because Apple engaged in anticompetitive conduct to aid sales ofthe accused products, the requested
`
`remedies are likely to increase competition, benefiting consumers and competitive conditions.
`
`The Commission has previously instituted an investigation involving wearable health and
`
`activity monitoring devices without directing the ALJ to make a recommended determination on the
`
`public interest. See Certain Wearable Monitoring Devices, Systems, and Components Thereof, Inv.
`
`No. 337-TA-1190, Notice of Institution of Investigation, 85 Fed. Reg. 2440 (Jan. 15, 2020). The
`
`requested remedies here likewise raise no public interest concerns. By protecting AliveCor’s
`
`

`

`innovative intellectual property, consumers, and the competitive conditions, the requested remedies
`
`will serve—rather than harm—the public interest.
`
`11.
`
`Use of the Accused Products in the United States
`
`The Respondents’ products potentially subject
`
`to remedial orders in the proposed
`
`investigation are wearable electronic devices and components thereof. As described in the
`
`Complaint, the Accused Products are used by consumers to look for heart arrhythmias and confirm
`
`the presence of arrhythmias by taking and analyzing ECGs on the wearable electronic device.
`
`III.
`
`The Requested Remedies Do Not Pose Any Public Health, Safety, 01' Welfare
`Concerns
`
`AliveCor’s requested remedial orders, if issued, will not raise any public health, safety, or
`
`welfare concerns. As explained below, there are numerous suppliers fully capable of providing
`
`consumers with wearable monitoring devices that can record ECGs and identify episodes of AFib.
`
`The availability ofthese substitute ECG monitors and AFib detection devices obviates any impact on
`
`the public health from exclusion of the accused Apple products.
`
`IV.
`
`Like or Directly-Competitive Articles Could Replace the Accused Products
`
`AliveCor’ s requested remedies would exclude certain versions ofApple smartwatches. The
`
`market for smartwatches in the United States has a diverse field ofparticipants that directly compete
`
`with Apple’s accused products and functionalities. Numerous suppliers sell competitive
`
`smartwatches, wearable electronic ECG devices, and other personal electronic devices capable of
`
`detecting AFib to United States consumers. Third parties such as Samsung and FitBit sell
`
`smartwatches with ECG functionality in the United States and could easily ramp up production to
`
`

`

`replace any excluded Apple products. For example, the Samsung Galaxy Watch 3 and the Samsung
`
`Watch Active 2,1 and the Fitbit Sense2 are all FDA-approved smartwatches with ECG fianctionality.
`
`Even ifnon-accused FDA-approved Smartwatches with ECG functionality, standing alone,
`
`cannot replace the products subject to an exclusion order, other products, including Apple’s own
`
`non-infringing products, can be combined to replace all accused products subject to an exclusion
`
`order. Apple and other suppliers sell smartwatches that do not have the infringing functionality and
`
`would not therefore be subject to an exclusion order. For example, the Apple Watch SE3; the Apple
`
`Watch Series 34;
`
`the Fitbit Versa 3, Versa 2, and Versa Lite5; and the Fossil Hybrid, Hybrid HR,
`
`Gen 4, Sport, and Gen 56 would still be available to consumers if an exclusion order issues in this
`
`investigation. Consumers would also be able to acquire portable ECG readers, like AliveCor’s
`
`KardiaMobile product.7 Alone or in combination, these substitute products are competitive with
`
`every aspect of Apple’s accused products. And more substitute products are likely coming soon.
`
`Exclusion of infringing products does not harm the public interest when substitute products
`
`are available and the accused products are manufactured overseas. See Certain Digital Televisions &
`
`Certain Prods. Containing Same & Methods of Using Same, Inv. No. 337-TA-6 l 7, Comm’n Op. at
`
`15 (Apr. 23, 2009). That is the case here.
`
`1 https://news.samsung.com/global/fda-cleared-electrocardiogram-monitor-app-is-
`available-in-the-us-starting-today—on-galaxy-watch3 -and-galaxy-watch-active2
`
`2 ht
`s://www.thever e.com/2020/9/l4/2l436090/fitbit-sense-ek -heart-fda-clearance-
`
`apple-samsung-withings
`
`3 https://www.applecom/apple-watch-se/
`
`4 https://www.apple.com/shop/buy—watch/apple-watch-series-3
`
`5 https://help_.f1tbit.com/articles/en US/Help article/2457.htm
`
`6 https://www.fossil.com/en-us/shopbr/watch-comparison-chart
`
`7 https://www.alivecor.com/kardiamobile
`
`

`

`V.
`
`Alternative Suppliers Have the Capacity to Replace the Accused Products
`
`No public interest concerns exist when the market contains an adequate supply of
`
`competitive or substitute products for those subject to a remedial order. See, e.g., Certain Elec.
`
`Digital Media Devices & Components Thereof, Inv. No. 337-TA-796, Comm’n Op. at 114-15 (Sept.
`
`6, 2013). The numerous suppliers listed above include major companies with established supply
`
`chains, like Samsung, Fitbit, and even Apple itself. They have the capacity to replace Apple’s
`
`infringing products without delay.
`
`VI.
`
`The Requested Remedial Orders Will Not Harm U.S. Consumers
`
`Consumers will not likely experience any negative impact from the requested remedial
`
`orders. Because numerous suppliers of smartwatches and wearable ECG devices have the capacity
`
`to immediately fill any void left by the exclusion of Apple’s infringing products, consumers will
`
`continue to have a wide variety of both type of products available to them. Apple’s past sales of its
`
`infringing products were, moreover, propped up by anticompetitive and unfair business practices.
`
`Apple introduced an infringing version of the Apple Watch after seeing the utility of—and
`
`copying—AliveCor’s KardiaBand and SmartRhythm technology. Apple then decided to eliminate
`
`AliveCor as a competitor and took the steps necessary to exclude AliveCor products from the
`
`market. Excluding Apple’ s infringing products, as requested in AliveCor’s complaint, will promote
`
`the competition Apple unfairly eliminated. Through its protection ofintellectual property rights, and
`
`against Apple’s anticompetitive conduct, the requested remedies will benefit consumers.
`
`VII. Conclusion
`
`The requested remedies raise no public interest concerns, and the strong public interest in
`
`protecting intellectual property rights outweighs any hypothetical harm. The Commission should
`
`decline to delegate consideration of the public interest to the ALJ, and it should issue a limited
`
`exclusion order and cease and desist orders if it determines that Apple violated Section 337.
`
`5
`
`

`

`Dated: April 20, 2021
`
`Respectfully submitted,
`
`_/s/S. Alex Lasher
`S. Alex Lasher
`
`QUINN EMANUEL URQUHART & SULLIVAN, LLP
`1300 I Street NW, Suite 900
`Washington DC. 20005
`Tel.: (202) 538-8000
`
`Counselfor AliveCor, Inc.
`
`

`

`UNITED STATES INTERNATIONAL TRADE COMMISSION
`
`WASHINGTON, D.C.
`
`
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`
`Investigation No. 337-TA-
`
`
`
`DEVICES WITH ECG
`
`FUNCTIONALITY AND
`
`COMPONENTS THEREOF
`
`COMPLAINT UNDER SECTION 337 OF THE
`
`TARIFF ACT OF 1930, AS AMENDED
`
`Complainant
`
`Proposed Respondent
`
`AliveCor, Inc.
`
`444 Castro St, Suite 600,
`
`Mountain View, CA 94041
`
`Tel. (650) 396-8650
`
`Apple Inc.
`One Apple Park Way,
`Cupertino, California 95014
`Tel. (408) 996—1010
`
`

`

`TABLE OF CONTENTS
`
`INTRODUCTION .............................................................................................................. 1
`
`II.
`
`PARTIES ............................................................................................................................ 3
`
`A.
`
`B.
`
`AliveCor ................................................................................................................. 3
`
`Apple ...................................................................................................................... 4
`
`III.
`
`BACKGROUND ................................................................................................................ 4
`
`A.
`
`Heart Disease in the United States ......................................................................... 4
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`AliveCor’s Wearable ECG Technology ................................................................. 5
`
`AliveCor’s First Heart Monitor .............................................................................. 6
`
`AliveCor’s KardiaBand and SmartRhythm Application ........................................ 7
`
`Apple Copies AliveCor’s Technology and Eliminates Competition ..................... 9
`
`AliveCor’s Continuing Investment in KardiaBand and SmartRhythm
`Technology ........................................................................................................... 10
`
`IV.
`
`THE TECHNOLOGY AND PRODUCTS AT ISSUE .................................................... 11
`
`THE ASSERTED PATENTS AND NONTECHNICAL DESCRIPTIONS OF THE
`
`INVENTIONS .................................................................................................................. 12
`
`A.
`
`The ’731 Patent .................................................................................................... 13
`
`1.
`
`2.
`
`3.
`
`Identification and Ownership of the ’731 Patent...................................... 13
`
`Foreign Counterparts to the ’731 Patent................................................... 14
`
`Non-Technical Description of the ’73] Patent ......................................... 14
`
`B.
`
`The ’941 Patent .................................................................................................... 15
`
`1.
`
`2.
`
`3.
`
`Identification and Ownership of the ’941 Patent...................................... 15
`
`Foreign Counterparts to the ’941 Patent................................................... 15
`
`Non-Technical Description of the ’94] Patent ......................................... 15
`
`C.
`
`The ’499 Patent .................................................................................................... 16
`
`1
`
`

`

`1.
`
`2.
`
`3.
`
`Identification and Ownership of the ’499 Patent...................................... 16
`
`Foreign Counterparts to the ’499 Patent................................................... 16
`
`Non-Technical Description of the ’499 Patent ......................................... 16
`
`D.
`
`Apple’s Infringement Of The Asserted Patents ................................................... 17
`
`1.
`
`2.
`
`3.
`
`Infringement of the ’731 Patent................................................................ 17
`
`Infringement of the ’941 Patth................................................................ 18
`
`Infringement of the ’499 Patent................................................................ 19
`
`VI.
`
`SPECIFIC INSTANCES OF UNFAIR IMPORTATION AND SALE ........................... 21
`
`A.
`
`Harmonized Tariff Schedule Numbers ................................................................. 21
`
`VII.
`
`RELATED LITIGATION ................................................................................................ 22
`
`VIII. LICENSEES TO THE ASSERTED PATENTS .............................................................. 22
`
`IX.
`
`THE DOMESTIC INDUSTRY RELATING TO THE ASSERTED PATENTS ............ 22
`
`A.
`
`B.
`
`Technical Prong .................................................................................................... 23
`
`Economic Prong ................................................................................................... 23
`
`X.
`
`RELIEF REQUESTED .................................................................................................... 24
`
`

`

`EXHIBIT LIST
`
`
`Exhibits Descri u tion
`
`U.S. Patent No. 10:638,941
`
`
`
`Assignment Records for U S. Patent No 10,638,941
`
`
`7
`List of Foreign Counterparts
`
`Confidential List of Licensees
`
`’731 Infringement Claim Charts
`p—a O
`’941 Infringement Claim Charts
`
`
`-
`
` 4
`
`Photographs and proof of purchase of the Apple Watch
`
`’731 Domestic Industry Claim Chart KardiaBand
`’94] Domestic Industry Claim Chart KardiaBand
`’499 Domestic Industry Claim Chart KardiaBand
`
`Confidential ’731 Domestic Industry Claim Chart Reference
`l6
`17
`Confidential ’941 Domestic Industry Claim Chart Reference
`
`18
`Confidential ’499 Domestic Industry Claim Chart Reference
`19
`Confidential Declaration of Siva Somayajula
`20
`Confidential Declaration of Clyde Hosein
`21
`Confidential Domestic Industry Product Reference
`Confidential License to the Asserted Patents
`_
`
`

`

`APPENDIX LIST
`
`
`endices Descri
`
`tion
`
`Prosecution History of US. Patent No. 10,595,731
`Patents and Applicable Pages of Technical References Mentioned in the
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`Prosecution History of US. Patent No. 10,595,731
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`Prosecution History of US. Patent No. 10,638,941
`Patents and Applicable Pages of Technical References Mentioned in the
`Prosecution History of US. Patent No. 10,63 8,941
`Prosecution History of US. Patent No. 9,572,499
`Patents and Applicable Pages of Technical References Mentioned in the
`Prosecution History of US. Patent No. 9,572,499
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`I.
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`INTRODUCTION
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`1.
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`AliveCor, Inc. (hereinafter “AliveCor” or “Complainant”) files this complaint
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`under Section 337 of the TariffAct of 1930, as amended, 19 U.S.C. § 1337, based on the Proposed
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`Respondent Apple Inc.’s (“Apple” or “Respondent”) unlawful importation into the United States,
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`sale for importation into the United States, and/or sale within the United States after importation
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`of certain wearable electronic devices with electrocardiogram (“ECG”) capability and
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`components thereof (“the Accused Devices”).
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`2.
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`These products infringe one or more claims of United States Patent Nos.
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`10,595,731 (“the ’731 patent”), 10,638,941 (“the ’941 patent”), and 9,572,499 (“the ’499 patent”)
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`(collectively,
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`the “Asserted Patents”), either literally or under the doctrine of equivalents.
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`AliveCor owns full rights, title, and interest in and to the Asserted Patents.
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`3.
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`Exemplary models of Apple’s wearable electronic devices at
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`issue in this
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`complaint include the Apple Watch Series 4, Apple Watch Series 5, and Apple Watch Series 6.
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`4.
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`The following table provides a summary of the asserted claims of the Asserted
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`Patents (independent claims in bold):
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`Patent No.
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`Asserted Claims
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`14, 15, 16, 17, 18, 19, 20, 21, 22, 23,
`10,595,731
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`24, 25, 26, 27, 28, 29, 30
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`1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12,13,
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`10,63 8,941
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`1, 2, 3, 4, 5, 6, 7, 8, 9,10,11,12,l3,
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`14,15,16,l7,18,l9, 20, 21, 22, 23
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`1, 2, 3, 4, 6, 7, 8, 9, 10,11,12,13,14,
`9,572,499
`16,17,18,l9, 20
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`5.
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`A domestic industry as required by 19 U.S.C. § l337(a)(2) and (3) exists and/or is
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`in the process ofbeing established in the United States relating to articles protected by AliveCor’s
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`Asserted Patents. AliveCor’s domestic industry includes significant investment in plant and
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`equipment, significant employment of labor and capital, and substantial investment in the
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`1
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`exploitation of the inventions claimed in AliveCor’s Asserted Patents,
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`including through
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`engineering, research, and development.
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`6.
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`Apple’s unlicensed and unauthorized use of AliveCor’s technology—including
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`the technology disclosed in the Asserted Patents—to import and sell wearable electronic devices
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`with ECG functionality in the United States constitutes an unfair act within the meaning of
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`Section 337.
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`7.
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`On information and belief, the Accused Devices are manufactured and/or sold for
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`importation into the United States, imported into the United States, and/or sold after importation
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`into the United States by or on behalf of Apple.
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`8.
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`AliveCor seeks as relief a permanent limited exclusion order under 19 U.S.C. §
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`1337(d) barring from entry into the United States infringing wearable electronic devices with
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`ECG capability and components thereof that are manufactured, sold for importation, and/or
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`imported by or on behalf of Apple.
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`9.
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`AliveCor further seeks as relief permanent cease and desist orders under 19 U.S.C.
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`§ 1337(f) prohibiting Apple from marketing, distributing, selling, offering for sale, warehousing
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`inventory for distribution, and otherwise transferring or bringing into the United States wearable
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`electronic devices with ECG functionality and components thereof that violate Section 337.
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`10.
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`AliveCor further seeks as relief a bond, for the 60-day Presidential review period
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`pursuant to 19 U.S.C. § 13370), for the importation of Respondent’s wearable electronic devices
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`with ECG functionality and components thereof that infringe one or more claims of the Asserted
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`Patents.
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`II.
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`PARTIES
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`A.
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`AliveCor
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`ll.
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`AliveCor is a corporation organized and existing pursuant to the laws of the State
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`of Delaware, and has its principal place of business at 444 Castro St, Suite 600, Mountain View,
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`CA 94041. 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.
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`12.
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`In 2017, AliveCor was first to bring to market an FDA cleared wearable consumer
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`device,
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`the KardiaBand, capable of monitoring the owner’s heart, detecting heart rate
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`irregularities, and then allowing the owner to perform an ECG to diagnose potential atrial
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`fibrillation (“AFib”).
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`In doing so, it became the first to ever receive FDA clearance for a non-
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`prescription wearable medical device that allowed the consumer to record an ECG reading.
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`13.
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`Since introducing KardiaBand, AliveCor has devoted significant resources to
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`bringing additional wearable electronic ECG devices to market.
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`14.
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`AliveCor currently employs approximately 95 individuals in the United States and
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`has made a substantial
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`investment
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`in domestic activities in the United States including,
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`engineering, design, data collection and analysis, customer service, research, and development to
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`bring products to market that make diagnosing AFib, and other irregular heart beat illnesses, more
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`accessible, more accurate, and more convenient.
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`15.
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`AliveCor’s patent-protected breakthroughs were acknowledged, and subsequently
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`duplicated, without license or permission, by Apple. This Complaint is one step, among