`1300 I Street NW, Suite 900, Washington, District of Columbia iooo5-3314 I TEL (zoz) 538-8000 FAX (zoz) 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
`U.S. 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 U.S. 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)(l)(i).
`
`One (1) electronic copy of the public exhibits to the Verified Complaint pursuant
`to Commission Rules 210.8(a)(l)(l) and 210.12(a)(9), including:
`
`qutnn emanuel urquhan & sumvan, HP
`AUSTIN I BOSTON I BRUSSELS I CHICAGO I HAMBURG I HONG KONG I HOUSTON I LONDON I LOS ANGELES I MANNHEIM I MUNICH I
`NEU ILLY-LA DEFENSE I NEW YORK I PARIS I PERTH I SALT LAKE CITY I SAN FRANCISCO I SEATTLE I SHANGHAI I SILICON VALLEY I
`STUTTGART I SYDNEY I TOKYO I WASHINGTON, DC I ZURICH
`
`1
`
`APPLE 1046
`
`
`
`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)(1); 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.S(a)(l)(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)(l). 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.
`
`2
`
`2
`
`
`
`Respectfully submitted
`
`Isl S. Alex Lasher
`S. Alex Lasher
`Counsel for Complainant AliveCor, Inc.
`
`3
`
`3
`
`
`
`QUinn emanuel trial lawvers I washington, de
`1300 I Street NW, Suite 900, Washington, District of Columbia iooo5-3314 I TEL (zoz) 538-8000 FAX (zoz) 538-8100
`
`WRITER'S DIRECT DIAL No.
`(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
`U.S. 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.
`
`qutnn emanuel urquhan & sumvan, HP
`AUSTIN I BOSTON I BRUSSELS I CHICAGO I HAMBURG I HONG KONG I HOUSTON I LONDON I LOS ANGELES I MANNHEIM I MUNICH I
`NEU ILLY-LA DEFENSE I NEW YORK I PARIS I PERTH I SALT LAKE CITY I SAN FRANCISCO I SEATTLE I SHANGHAI I SILICON VALLEY I
`STUTTGART I SYDNEY I TOKYO I WASHINGTON, DC I ZURICH
`
`4
`
`
`
`Respectfully submitted
`
`Isl S. Alex Lasher
`S. Alex Lasher
`Counsel for Complainant AliveCor, Inc.
`
`2
`
`5
`
`
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG
`FUNCTIONALITY AND COMPONENTS
`THEREOF
`
`Inv. No. 337-TA-- - - -
`
`CERTIFICATION
`
`I, S. Alex Lasher, counsel for Complainant AliveCor, Inc., declare as follows:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`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
`
`1
`
`6
`
`
`
`7.
`
`8.
`
`9.
`
`10.
`
`of this information also wouldimpair the Commission's ability to obtain
`information necessary to perform its statutory function.
`
`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.
`
`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.
`
`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.
`
`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.
`
`Isl S. Alex Lasher
`S. Alex Lasher
`
`2
`
`7
`
`
`
`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 California-based engineers, AliveCor was first company to bring to market an FDA-cleared
`
`wearable consumer device capable of monitoring the owner's heart rate, detecting episodes of atrial
`
`8
`
`
`
`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 oflike 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 of the 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 oflnstitution oflnvestigation, 85 Fed. Reg. 2440 (Jan. 15, 2020). The
`
`requested remedies here likewise raise no public interest concerns. By protecting AliveCor's
`
`2
`
`9
`
`
`
`innovative intellectual property, consumers, and the competitive conditions, the requested remedies
`
`will serve-rather than harm-the public interest.
`
`II.
`
`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, or 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 of these 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 of Apple smartwatches. The
`
`market for smartwatches in the United States has a diverse field of participants 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
`
`3
`
`10
`
`
`
`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 functionality.
`
`Even if non-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-617, 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(cid:173)
`available-in-the-us-starting-today-on-galaxy-watch3-and-galaxy-watch-active2
`
`2 https://www .theverge.com/2020/9/14/21436090/fitbit-sense-ekg-heart-fda-clearance-
`apple-samsung-withings
`
`3 https://www .apple.com/apple-watch-se/
`
`4 https://www.apple.com/shop/buy-watch/apple-watch-series-3
`
`5 https://help.fitbit.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
`
`4
`
`11
`
`
`
`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'nOp. 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 of intellectual 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
`
`12
`
`
`
`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 D.C. 20005
`Tel.: (202) 538-8000
`
`Counsel for AliveCor, Inc.
`
`6
`
`13
`
`
`
`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- _ _
`
`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
`
`14
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION .............................................................................................................. 1
`
`PARTIES ............................................................................................................................ 3
`
`A.
`
`B.
`
`AliveCor ................................................................................................................. 3
`
`Apple ...................................................................................................................... 4
`
`III.
`
`BACKGROUND ................................................................................................................ 4
`
`A.
`
`B.
`
`C.
`
`Heart Disease in the United States ........................................................................ .4
`
`AliveCor's Wearable ECG Technology ................................................................. 5
`
`AliveCor's First Heart Monitor .............................................................................. 6
`
`D.
`
`AliveCor's KardiaBand and SmartRhythm Application ........................................ 7
`
`E.
`
`F.
`
`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
`
`V.
`
`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 '731 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 '941 Patent ......................................... 15
`
`C.
`
`The '499 Patent .................................................................................................... 16
`
`1
`
`15
`
`
`
`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. ............................................................... 1 7
`
`Infringement of the '941 Patent.. .............................................................. 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
`
`2
`
`16
`
`
`
`EXHIBIT LIST
`
`Exhibits Description
`1
`U.S. Patent No. 10,595,731
`2
`U.S. Patent No. 10,638,941
`3
`U.S. Patent No. 9,572,499
`Assignment Records for U.S. Patent No. 10,595,731
`4
`5
`Assignment Records for U.S. Patent No. 10,638,941
`Assignment Records for U.S. Patent No. 9,572,499
`6
`List of Foreign Counterparts
`7
`Confidential List of Licensees
`8
`'731 Infringement Claim Charts
`9
`'941 Infringement Claim Charts
`10
`'499 Infringement Claim Charts
`11
`Photographs and proof of purchase of the Apple Watch
`12
`'731 Domestic Industry Claim Chart KardiaBand
`13
`'941 Domestic Industry Claim Chart KardiaBand
`14
`'499 Domestic Industry Claim Chart KardiaBand
`15
`Confidential '731 Domestic Industry Claim Chart Reference
`16
`Confidential '941 Domestic Industry Claim Chart Reference
`17
`Confidential '499 Domestic Industry Claim Chart Reference
`18
`Confidential Declaration of Siva Somayajula
`19
`Confidential Declaration of Clyde Hosein
`20
`21
`Confidential Domestic Industry Product Reference
`22
`Confidential License to the Asserted Patents
`
`3
`
`17
`
`
`
`APPENDIX LIST
`
`Appendices Description
`A
`Prosecution History of U.S. Patent No. 10,595,731
`B
`Patents and Applicable Pages of Technical References Mentioned in the
`Prosecution History of U.S. Patent No. 10,595,731
`Prosecution History of U.S. Patent No. 10,638,941
`Patents and Applicable Pages of Technical References Mentioned in the
`Prosecution History of U.S. Patent No. 10,638,941
`Prosecution History of U.S. Patent No. 9,572,499
`Patents and Applicable Pages of Technical References Mentioned in the
`Prosecution History of U.S. Patent No. 9,572,499
`
`C
`D
`
`E
`F
`
`4
`
`18
`
`
`
`I.
`
`INTRODUCTION
`
`1.
`
`AliveCor, Inc. (hereinafter "AliveCor" or "Complainant") files this complaint
`
`under Section 337 of the Tariff Act of1930, as amended, 19 U.S.C. § 1337, based on the Proposed
`
`Respondent Apple Inc.' s ("Apple" or "Respondent") unlawful importation into the United States,
`
`sale for importation into the United States, and/or sale within the United States after importation
`
`of certain wearable electronic devices with electrocardiogram ("ECG") capability and
`
`components thereof ("the Accused Devices").
`
`2.
`
`These products infringe one or more claims of United States Patent Nos.
`
`10,595,731 ("the '731 patent"), 10,638,941 ("the '941 patent"), and 9,572,499 ("the '499 patent")
`
`( collectively, the "Asserted Patents"), either literally or under the doctrine of equivalents.
`
`AliveCor owns full rights, title, and interest in and to the Asserted Patents.
`
`3.
`
`Exemplary models of Apple's wearable electronic devices at issue m this
`
`complaint include the Apple Watch Series 4, Apple Watch Series 5, and Apple Watch Series 6.
`
`4.
`
`The following table provides a summary of the asserted claims of the Asserted
`
`Patents (independent claims in bold):
`
`Patent No.
`
`10,595,731
`
`10,638,941
`
`9,572,499
`
`Asserted Claims
`1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
`14, 15, 16, 17, 18, 19, 20, 21, 22, 23,
`24,25,26,27,28,29,30
`1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
`14, 15, 16, 17, 18, 19,20,21,22,23
`1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14,
`16, 17, 18, 19, 20
`
`5.
`
`A domestic industry as required by 19 U.S.C. § 1337(a)(2) and (3) exists and/or is
`
`in the process of being established in the United States relating to articles protected by AliveCor's
`
`Asserted Patents. AliveCor's domestic industry includes significant investment in plant and
`
`equipment, significant employment of labor and capital, and substantial investment in the
`
`1
`
`19
`
`
`
`exploitation of the inventions claimed m AliveCor's Asserted Patents, including through
`
`engineering, research, and development.
`
`6.
`
`Apple's unlicensed and unauthorized use of AliveCor's technology-including
`
`the technology disclosed in the Asserted Patents-to import and sell wearable electronic devices
`
`with ECG functionality in the United States constitutes an unfair act within the meaning of
`
`Section 337.
`
`7.
`
`On information and belief, the Accused Devices are manufactured and/or sold for
`
`importation into the United States, imported into the United States, and/or sold after importation
`
`into the United States by or on behalf of Apple.
`
`8.
`
`AliveCor seeks as relief a permanent limited exclusion order under 19 U.S.C. §
`
`1337(d) barring from entry into the United States infringing wearable electronic devices with
`
`ECG capability and components thereof that are manufactured, sold for importation, and/or
`
`imported by or on behalf of Apple.
`
`9.
`
`AliveCor further seeks as relief permanent cease and desist orders under 19 U.S.C.
`
`§ 1337(f) prohibiting Apple from marketing, distributing, selling, offering for sale, warehousing
`
`inventory for distribution, and otherwise transferring or bringing into the United States wearable
`
`electronic devices with ECG functionality and components thereof that violate Section 337.
`
`10.
`
`AliveCor further seeks as relief a bond, for the 60-day Presidential review period
`
`pursuant to 19 U.S.C. § 1337(i), for the importation of Respondent's wearable electronic devices
`
`with ECG functionality and components thereof that infringe one or more claims of the Asserted
`
`Patents.
`
`2
`
`20
`
`
`
`II.
`
`PARTIES
`
`A.
`
`AliveCor
`
`11.
`
`AliveCor is a corporation organized and existing pursuant to the laws of the State
`
`of Delaware, and has its principal place of business at 444 Castro St, Suite 600, Mountain View,
`
`CA 94041. AliveCor is a leader in the design and development of products that provide
`
`intelligent, highly-personalized heart data to help diagnose heart conditions.
`
`12.
`
`In 2017, AliveCor was first to bring to market an FDA cleared wearable consumer
`
`device, the KardiaBand, capable of monitoring the owner's heart, detecting heart rate
`
`irregularities, and then allowing the owner to perfo