quinn emanuel trial lawyers | washington, dc
`
`1300 I Street NW, Suite 900, Washington, District of Columbia 20005-3314 | TEL (202) 538-8000 FAX (202) 538-8100
`
`WRITER'S DIRECT DIAL NO.
`(202) 538-8104
`
`WRITER'S EMAIL ADDRESS
`alexlasher@quinnemanuel.com
`
`April 26, 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,
`Docket No. 337-3545
`
`Dear Secretary Barton:
`
`Pursuant to 19 C.F.R. § 210.14(a), AliveCor, Inc., respectfully submits the enclosed
`Verified Amended Complaint in support of its request 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.
`
`The Verified Amended Complaint adds the names and addresses of AliveCor’s counsel to
`the cover page of the Complaint; modifies paragraphs 42, 54, 64, 68, and 69 of the Complaint;
`corrects Exhibit 5 to the Complaint; and adds a new Exhibit 23 to the Complaint.
`
`The changes do not otherwise alter or impact AliveCor’s Complaint, and the Verified
`Amended Complaint does not add additional respondents or allege additional unfair acts. See 19
`C.F.R. § 210.14(a).
`
`Copies of the Verified Amended Complaint, corrected Exhibit 5, and Exhibit 23 are
`included in this filing.
`
`Please contact me with any questions regarding this filing.
`
`quinn emanuel urquhart & sullivan, llp
`LOS ANGELES | NEW YORK | SAN FRANCISCO | SILICON VALLEY | CHICAGO | WASHINGTON, DC | HOUSTON | SEATTLE | BOSTON | SALT LAKE CITY
`LONDON | TOKYO | MANNHEIM | HAMBURG | PARIS | MUNICH | SYDNEY | HONG KONG | BRUSSELS | ZURICH | SHANGHAI | PERTH | STUTTGART
`
`

`

`Respectfully submitted
`
`/s/ S. Alex Lasher
`S. Alex Lasher
`Counsel for Complainant AliveCor, Inc.
`
`2
`
`

`

`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- _____
`
`AMENDED COMPLAINT UNDER SECTION 337 OF THE
`TARIFF ACT OF 1930, AS AMENDED
`
`Complainant
`
`AliveCor, Inc.
`444 Castro St, Suite 600,
`Mountain View, CA 94041
`Tel. (650) 396-8650
`
`Proposed Respondent
`
`Apple Inc.
`One Apple Park Way,
`Cupertino, California 95014
`Tel. (408) 996–1010
`
`Counsel for Complainant AliveCor, Inc.
`
`S. Alex Lasher
`QUINN EMANUEL URQUHART & SULLIVAN,
`LLP
`1300 I Street NW, Suite 900
`Washington D.C. 20005
`Tel.: (202) 538-8000
`
`Sean S. Pak
`Andrew M. Holmes
`QUINN EMANUEL URQUHART & SULLIVAN,
`LLP
`50 California Street, 22nd Floor
`San Francisco, CA 94111
`Tel.: (415) 875-6600
`
`

`

`Adam B. Wolfson
`QUINN EMANUEL URQUHART & SULLIVAN,
`LLP
`865 S. Figueroa St., 10th Floor
`Los Angeles, California 90017
`TEL: (213) 443-3000
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION..............................................................................................................1
`
`PARTIES............................................................................................................................3
`
`A.
`
`B.
`
`AliveCor .................................................................................................................3
`
`Apple ......................................................................................................................4
`
`III.
`
`BACKGROUND................................................................................................................4
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`Heart Disease in the United States .........................................................................4
`
`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.
`
`V.
`
`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 ’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
`
`

`

`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.........................................17
`
`D.
`
`Apple’s Infringement Of The Asserted Patents ...................................................17
`
`1.
`
`2.
`
`3.
`
`Infringement of the ’731 Patent................................................................17
`
`Infringement of the ’941 Patent................................................................18
`
`Infringement of the ’499 Patent................................................................20
`
`VI.
`
`SPECIFIC INSTANCES OF UNFAIR IMPORTATION AND SALE...........................21
`
`A.
`
`Harmonized Tariff Schedule Numbers.................................................................22
`
`VII.
`
`RELATED LITIGATION................................................................................................22
`
`VIII. LICENSEES TO THE ASSERTED PATENTS..............................................................22
`
`IX.
`
`THE DOMESTIC INDUSTRY RELATING TO THE ASSERTED PATENTS............23
`
`A.
`
`B.
`
`Technical Prong....................................................................................................23
`
`Economic Prong ...................................................................................................23
`
`X.
`
`RELIEF REQUESTED ....................................................................................................25
`
`2
`
`

`

`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
`4
`Assignment Records for U.S. Patent No. 10,595,731
`5
`Assignment Records for U.S. Patent No. 10,638,941
`6
`Assignment Records for U.S. Patent No. 9,572,499
`7
`List of Foreign Counterparts
`8
`Confidential List of Licensees
`9
`’731 Infringement Claim Charts
`10
`’941 Infringement Claim Charts
`11
`’499 Infringement Claim Charts
`12
`Photographs and proof of purchase of the Apple Watch
`13
`’731 Domestic Industry Claim Chart KardiaBand
`14
`’941 Domestic Industry Claim Chart KardiaBand
`15
`’499 Domestic Industry Claim Chart KardiaBand
`16
`Confidential ’731 Domestic Industry Claim Chart Reference
`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
`22
`Confidential License to the Asserted Patents
`23
`Certificate of Correction for U.S. Patent No. 10,638,941
`
`3
`
`

`

`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
`
`

`

`I.
`
`INTRODUCTION
`
`1.
`
`AliveCor, Inc. (hereinafter “AliveCor” or “Complainant”) files this complaint
`
`under Section 337 of the Tariff Act of 1930, 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 in 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
`
`

`

`exploitation of the inventions claimed in 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(j), 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
`
`

`

`II.
`
`PARTIES
`
`A.
`
`11.
`
`AliveCor
`
`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 perform an ECG to diagnose potential atrial
`
`fibrillation (“AFib”). In doing so, it became the first to ever receive FDA clearance for a non-
`
`prescription wearable medical device that allowed the consumer to record an ECG reading.
`
`13.
`
`Since introducing KardiaBand, AliveCor has devoted significant resources to
`
`bringing additional wearable electronic ECG devices to market.
`
`14.
`
`AliveCor currently employs approximately 95 individuals in the United States and
`
`has made a substantial investment in domestic activities in the United States including,
`
`engineering, design, data collection and analysis, customer service, research, and development to
`
`bring products to market that make diagnosing AFib, and other irregular heart beat illnesses, more
`
`accessible, more accurate, and more convenient.
`
`15.
`
`AliveCor’s patent-protected breakthroughs were acknowledged, and subsequently
`
`duplicated, without license or permission, by Apple. This Complaint is one step, among others,
`
`AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented
`
`technology—including the ability to take an ECG reading on the Apple Watch, and to perform
`
`3
`
`

`

`heartrate analysis—as well as Apple’s efforts to eliminate AliveCor as competition in the
`
`heartrate analysis market for the Apple Watch.
`
`B.
`
`16.
`
`Apple
`
`Apple is a California corporation with a principal place of business at One Apple
`
`Park Way, Cupertino, California 95014.
`
`17.
`
`On information and belief, Apple designs, develops, tests, imports into the United
`
`States, offers for sale, and sells in the United States after importation infringing wearable
`
`electronic devices, including those sold under the tradenames Apple Watch Series 4, Apple Watch
`
`Series 5, and Apple Watch Series 6.
`
`III.
`
`BACKGROUND
`
`A.
`
`18.
`
`Heart Disease in the United States
`
`According to the Centers for Disease Control and Prevention (the “CDC”), heart
`
`disease is the leading cause of death for men, women, and people of most racial and ethnic groups
`
`in the United States. One person dies every 36 seconds in the United States from cardiovascular
`
`disease.
`
`19.
`
`AFib is one type of heart disease. AFib is a quivering or irregular heartbeat
`
`(arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related
`
`complications. Normally, the heart contracts and relaxes to a regular beat. When a person has
`
`AFib, however, the normal beating in the upper chambers of the heart (the two atria) is irregular,
`
`and blood does not flow as well as it should from the atria to the lower chambers of the heart (the
`
`two ventricles). AFib may happen in brief episodes, or it may be a permanent condition.
`
`4
`
`

`

`20. Millions of Americans live with AFib. Untreated atrial fibrillation doubles the risk
`
`of heart-related deaths and is associated with a 5-fold increased risk for stroke. Despite this, many
`
`patients are unaware that they have AFib—or that it is a serious condition at all.
`
`21.
`
`There are different types of atrial fibrillation, but the most difficult type of AFib
`
`to diagnose is paroxysmal atrial fibrillation. This type of atrial fibrillation is episodic—it comes
`
`and goes in paroxysms, or sudden attacks. A principal feature of this type of atrial fibrillation is
`
`its unpredictability.1 For a patient, that unpredictability makes diagnosis difficult--the episodes
`
`may occur when no doctor is monitoring the heart. When a patient does go to a doctor, the doctor
`
`may find that the heart is operating in perfect order.
`
`B.
`
`22.
`
`AliveCor’s Wearable ECG Technology
`
`In 2010, David Albert, Bruce Satchwell, and Kim Barnett began working together
`
`to address the leading cause of death in the United States: heart disease. Their idea was to give
`
`patients the ability to monitor their heart health with an accurate and easy to use device that
`
`allowed individuals to take their own ECG.
`
`23.
`
`In late December 2010, Dr. Albert uploaded a video demo of an ECG device that
`
`could work with an iPhone to YouTube. The video went viral with more than 100,000 views in
`
`the first few days, and it made AliveCor’s ECG device one of the most talked about technologies
`
`at the 2011 Consumer Electronics Show.
`
`24.
`
`Shortly after the 2011 Consumer Electronics Show, Dr. Albert, Mr. Satchwell, and
`
`Mr. Barnett officially formed AliveCor in order to bring their novel ECG device to market.
`
`
`1 “Sometimes the symptoms last for minutes, sometimes they can last for days; a principle feature
`of this type of AFib is that it’s unpredictable.” See, e.g., https://www.alivecor.com/
`blog/articles/the_3_forms_of_AFib/
`
`5
`
`

`

`C.
`
`25.
`
`AliveCor’s First Heart Monitor
`
`Just two years later, in 2013, AliveCor introduced the first FDA approved portable
`
`ECG product. That product—the AliveCor Heart Monitor—incorporated two electrodes into an
`
`iPhone case. Those electrodes allowed the user to take real-time ECG readings by either holding
`
`the monitor in their hands or by pressing it against their chest. Before reaching the market,
`
`AliveCor demonstrated the effectiveness and accuracy of its revolutionary heart monitor through
`
`clinical trials.
`
`26.
`
`AliveCor participated in two clinical trials to field test both the hardware and the
`
`accompanying iPhone application for the AliveCor Heart Monitor. One study investigated how
`
`AliveCor’s single-lead ECG compared to a traditional 12-lead device. Another examined if 54
`
`participants could figure out how to use the case properly, with no previous medical training. The
`
`latter study not only showed the device could be used without specialized training, but also led to
`
`the diagnosis of two serious heart problems.
`
`27.
`
`The AliveCor Heart Monitor system consisted of the heart monitor itself, which
`
`could be mounted onto the back of most smartphones, or embedded into a special case for the
`
`iPhone, and the AliveECG app, which showed the user’s ECG reading. To check heart activity,
`
`the user placed the detector against their fingers or chest. The detector then recorded an ECG and
`
`sent that data to the app on a smartphone, using an ultrasonic signal that is sent to the phone’s
`
`microphone.
`
`6
`
`

`

`28.
`
`The data was also sent to AliveCor’s servers so that the AFib Detector algorithms
`
`could analyze the data and interpret it. Once the ECG reading was obtained, it could be sent to a
`
`doctor or a heart specialist for more information.
`
`Figure 1: AliveCor Heart Monitor
`
`AliveCor’s KardiaBand and SmartRhythm Application
`
`In late 2014 or early 2015, AliveCor began working on what ultimately became
`
`D.
`
`29.
`
`the AliveCor KardiaBand. The KardiaBand was a replacement watch band for a user’s Apple
`
`Watch. The KardiaBand was the first FDA cleared medical accessory for the Apple Watch.
`
`KardiaBand, in conjunction with the Kardia watch app, enabled a user to record an ECG on their
`
`wrist anywhere in the world. KardiaBand entered the U.S. market at the end of 2017.
`
`30.
`
`Like the AliveCor Heart Monitor,2 the KardiaBand was also easy to use and
`
`activate. Recording an ECG took just three steps: (i) open the Kardia watch app; (ii) open the in-
`
`app instructions; and (iii) put your right thumb on the KardiaBand outer electrode while ensuring
`
`the inner electrode was in contact with the skin of the left wrist.
`
`
`2 The current AliveCor Heart Monitor is marketed under the KardiaMobile brand name.
`
`7
`
`

`

`Figure 2: AliveCor KardiaBand
`
`31.
`
`Along with the KardiaBand for Apple Watch, AliveCor also introduced a new
`
`software feature in its Kardia App called SmartRhythm. SmartRhythm used artificial intelligence
`
`to continuously evaluate the correlation between heart activity and physical activity using heart
`
`rate data and activity data sensors in the Apple watch. SmartRhythm was developed to work in
`
`coordination with the KardiaBand and the Kardia App to detect and notify users of heart rate
`
`irregularities. Users were then asked to record an ECG which could confirm the occurrence of
`
`AFib.
`
`32.
`
`Dr. Ronald Karlsberg of Cedars Sinai Heart Institute and UCLA’s School of
`
`Medicine described the combination of KardiaBand and SmartRhythm as “a paradigm shift for
`
`cardiac care as well as an important advance in healthcare.” See
`
`https://www.alivecor.com/press/press_release/fda-clears-first-medical-device-for-apple-watch/.
`
`Dr. Karlsberg further explained the significance of AliveCor’s innovation: “Today, [ECGs] are
`
`available only in offices and hospitals, using complex equipment, and usually only after a life
`
`threatening event, for example a stroke. With an EKG device on the wrist, AFib can be detected
`
`wherever the patient is, 24 hours a day. In randomized research trials, KardiaMobile, the first
`
`AliveCor [ECG] device, proved to be superior to routine care provided by physicians. Today,
`
`KardiaBand is a giant leap in personalized health care.” Id.
`
`8
`
`

`

`33.
`
`The SmartRhythm algorithm was trained, via user data, to monitor a user in real
`
`time and provide alerts to users when they were experiencing unexpected heart rates. These
`
`unexpected heart rates were potential occurrences of AFib. Users could then record an ECG which
`
`would confirm possible AFib. Initially, SmartRhythm was trained to recognize discordant heart
`
`rates by looking at a user’s heart rate as provided by the Apple Watch. Over time, AliveCor
`
`developed a neural network architecture that could project what a patient’s future heart rate should
`
`be such that when the projected heart rate did not match the actual heart rate, the user would
`
`receive a notification and be instructed to record an ECG.
`
`34.
`
`SmartRhythm used heart rate data generated by the Apple Watch to identify heart
`
`rate irregularities and suggest recording an ECG. An algorithm in the Apple Watch uses a
`
`photoplethysmogram (“PPG”) sensor to report a heart rate. PPG data was converted to heart rate
`
`data at certain times based on proprietary Apple code.
`
`E.
`
`35.
`
`Apple Copies AliveCor’s Technology and Eliminates Competition
`
`After AliveCor presented KardiaBand publicly, its founder Dr. Albert was
`
`invited to Apple’s campus by Dr. Michael O’Reilly, Apple’s Vice President of Medical
`
`Technology, to present to Apple on KardiaBand. Dr. Albert demonstrated KardiaBand’s
`
`operation to Apple engineers and Apple’s COO, Jeff Williams. Mr. Williams told Dr. Albert
`
`that Apple wanted to figure out how to work with AliveCor.
`
`36.
`
`A few months later, Dr. Albert and AliveCor’s then-CEO met with Phil Schiller,
`
`Apple’s SVP of Worldwide Marketing, in order to further demonstrate the KardiaBand product.
`
`Unbeknownst to AliveCor, however, Apple was using these meetings to gather information on
`
`the operation of KardiaBand. Apple recognized the value in the combination of AliveCor’s
`
`9
`
`

`

`KardiaBand and SmartRhythm products and wanted to take those ideas as their own and eliminate
`
`AliveCor and everyone else as competition.
`
`37.
`
`In fact, after seeing the utility of KardiaBand and SmartRhythm, Apple decided
`
`to copy these features and introduce a version of an Apple Watch with its own ECG and AFib
`
`analysis and reporting functionality. In late 2018, Apple announced that it was introducing its
`
`own ECG app and irregular heart rhythm notification feature as part of an update to the
`
`Operating System for the Apple Watch Series 4.
`
`38.
`
`After Apple introduced its KardiaBand and SmartRhythm competitor products, it
`
`decided to eliminate AliveCor as a competitor. Specifically, with the Apple Watch series 4, Apple
`
`updated the watch operating systems from OS4 to OS5. This operating system update included
`
`changes to the algorithm the Watch OS used to report heart rates in specific ways that made it
`
`impossible for KardiaBand and SmartRhythm (as well as all other third party heartrate analysis
`
`app providers) to identify and predict unexpected heartrates and arrhythmias and suggest users
`
`record an ECG for confirming potentially occurrences of AFib.
`
`39.
`
`Ultimately, the changes Apple made to its operating system in OS5 and the
`
`introduction of Apple’s copycat ECG watches compelled AliveCor to pull the KardiaBand
`
`product and SmartRhythm from the market in 2018. Despite the fact that KardiaBand is no longer
`
`sold, AliveCor continues to collect and analyze information from KardiaBand customers as well
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`as support customers who had previously purchased the products and continue to use it.
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`F.
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`AliveCor’s Continuing Investment in KardiaBand and SmartRhythm
`Technology
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`40.
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`AliveCor spent millions of dollars and thousands of man hours developing
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`KardiaBand and SmartRhythm, including time and money to engineer the product and clinical
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`studies to verify it worked.
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`41.
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`After Apple changed its heart rate reporting algorithm, but before KardiaBand and
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`SmartRhythm were pulled from the market in 2018, AliveCor began development of its own
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`hardware platform for detecting AFib that builds on the technology introduced in the KardiaBand
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`product and SmartRhythm app. As described in more detail in Confidential Exhibits 19 and 20,
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`since Apple's actions caused AliveCor to remove KardiaBand and SmartRhythm from the market,
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`AliveCor has continued to invest significant resources into developing alternative wearable
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`electronic ECG devices that incorporate the inventions of the Asserted Patents.
`
`IV.
`
`THE TECHNOLOGY AND PRODUCTS AT ISSUE
`
`42.
`
`Pursuant to Commission Rules 210.10(b)(1) and 210.12(a)(12), the accused
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`products are Apple Watches with ECG functionality, and hardware and software components
`
`thereof.3
`
`43.
`
`The technology at issue relates to wearable electronic devices with ECG
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`functionality.
`
`44.
`
`Given the unpredictable nature of AFib, it is difficult to diagnose. Before
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`AliveCor, the state-of-the-art for monitoring the heart for episodes of AFib was expensive and
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`either (1) short-term and unwieldy or (2) or long-term. The first kind of device required wearing
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`sensors with wires strapped across the body, like those for a sleep study. The second kind of
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`device required a sensor to be implanted underneath the skin and cost tens of thousands of dollars.
`
`45.
`
`AliveCor solved the difficulty in diagnosis and the problems with prior AFib
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`monitors by integrating sensors into a wearable device, such as a smartwatch that allowed for
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`comfortable, long-term monitoring of the heartbeat for a few hundred dollars, instead of
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`thousands or tens of thousands of dollars.
`
`
`3 Representative samples of the products at issue are available upon request.
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`46.
`
`In bringing this new technology to market, AliveCor had to win consumer trust.
`
`The margin of error for the technology was small. If the heart rate discordance technology was
`
`too sensitive, it risked sending too many false positives, leading consumers to ignore the request
`
`to record an ECG when a potential real episode of AFib was occurring. On the other hand, if the
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`heart rate discordance technology was not sensitive enough it would fail to notify the owner when
`
`the heartbeat really was erratic thereby failing to perform its designed function.
`
`47.
`
`To reduce the risk of these kinds of errors, AliveCor developed a method for
`
`marshaling data from other sensors in the smartwatch in order to compare the activity level, the
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`heart rate, and the heart rate variability of the wearer. The method looks for discordance between
`
`those values to determine when to notify the wearer of a possible heart issue and to suggest an
`
`ECG.
`
`48.
`
`Apple intentionally replicated AliveCor’s patented technology into its Apple
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`Watch, and took other steps to eliminate AliveCor as a competitor. This Investigation is one
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`avenue, among others, AliveCor is taking to seek redress for Apple’s duplicitous conduct.
`
`V.
`
`THE ASSERTED PATENTS AND NONTECHNICAL DESCRIPTIONS OF THE
`INVENTIONS4
`
`49.
`
`The claims of the ’731, the ’941, and the ’499 Patents are novel, unconventional
`
`and focus on specific means and methods of using specialized sensors in a wearable device to
`
`improve upon existing cardiac monitoring technology. The Asserted Patents explain the state of
`
`the art in arrhythmia diagnosis, the limitations in known diagnostic techniques and diagnostic
`
`
`4 All non-technical descriptions of the patents herein are presented to give a general
`background of those patents. These descriptions are not intended to be used nor should they be
`used for purposes of patent claim construction. Complainant presents these statements subject to
`and without waiver of its right to argue that claim terms should be construed in a particular way
`under claim interpretation jurisprudence and the relevant evidence.
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`equipment, and the need for the inventors’ improvement in diagnostic techniques and
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`equipment. ’941 Patent at 1:26-3:26; ’499 Patent at 1:20-2:4. The claims then recite specific and
`
`novel implementations of apparatus and methods used for diagnosing intermittent arrhythmias
`
`that address the limitations in the prior art including the requirement that the users be made aware
`
`of the potential arrhythmia and have ready access to specialized diagnostic equipment in a clinical
`
`setting.
`
`50.
`
`In the Asserted Patents, a unique and novel combination of sensors are used to
`
`sense certain parameter values such as, for example, heart rate and activity level, which are then
`
`analyzed to predict or determine the presence of an arrhythmia. See, e.g., ’731 Patent at 26:27-
`
`52. These novel wearable devices differ from the disclosed and known prior art for several reasons
`
`including
`
`the
`
`incorporation and coordinated use of photoplethysmography (“PPG”),
`
`electrocardiography (“ECG”), and movement sensors in order to collect accurate, real-time
`
`cardiac data of the user and compare such data to the expected cardiac data based on the activity
`
`level of the user. Id. at 4:46-5:29. The collected data also allows device makers to train machine
`
`learning algorithms that can more quickly predict and notify users of potential arrhythmias using
`
`heart rate data along with information and signals from the other sensors in the watch. Id. at 4:2-
`
`10, 5:15-19. The claimed inventions thus offer a uniquely convenient heart monitoring apparatus
`
`and methods that leverages wearability, specialized sensors, and machine learning to generate
`
`more accessible and effective diagnosis of potentially dangerous arrhythmia conditions.
`
`A.
`
`The ’731 Patent
`
`1.
`
`Identification and Ownership of the ’731 Patent
`
`51.
`
`AliveCor owns by assignment the right, title and interest in United States Patent
`
`No. 10,595,731, titled “Methods and systems for arrhythmia tracking and scoring,” which issued
`
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`on May 5, 2020, naming David E. Albert, Omar Dawood, Lev Korzinov, Iman Abuzeid, Nupur
`
`Srivastava, Fei Wang, Euan Thomson, and Ravi Gopalakrishnan as co-inventors. The ’731 patent
`
`issued from U.S. Patent Application Serial No. 16/158,112, filed on October 28, 2018, and expires
`
`on December 12, 2034. A copy of the ’731 patent is attached as Exhibit 1. A copy of the
`
`assignment from the named inventors to AliveCor is attached as Exhibit 4. A copy of the
`
`prosecution history of the ’731 patent is attached as Appendix A.5 Copies of each patent and
`
`applicable pages of each technical reference mentioned in the prosecution history of the ’731
`
`patent are attached as Appendix B.
`
`2.
`
`Foreign Counterparts to the ’731 Patent
`
`52.
`
`Exhibit 7 lists each foreign patent and each pending foreign patent application (not
`
`already issued as a patent), and each foreign patent application that has be