Case: 23-1509 Document: 35 Page: 1 Filed: 07/14/2023
`
`Appeal Nos. 23-1509, 23-1553
`
`United States Court of Appeals for the Federal Circuit
`
`ALIVECOR, INC.
`
`v.
`INTERNATIONAL TRADE COMMISSION
`
`APPLE INC.
`
`APPLE INC.
`
`v.
`INTERNATIONAL TRADE COMMISSION
`
`ALIVECOR, INC.,
`
`Appellant,
`
`Appellee,
`
`Intervenor.
`
`Appellant,
`
`Appellee,
`
`Intervenor.
`On Appeal from the United States International Trade Commission
`Inv. No. 337-TA-1266
`
`CORRECTED NONCONFIDENTIAL OPENING BRIEF OF
`APPELLANT ALIVECOR, INC.
`
`William B. Adams
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
`williamadams@quinnemanuel.com
`(212) 849-7000
`
`Sean S. Pak
`QUINN EMANUEL URQUHART
`& SULLIVAN, LLP
`50 California Street, 22nd Floor
`San Francisco, California 94111
`seanpak@quinnemanuel.com
`(415) 875-6600
`Counsel for AliveCor, Inc.
`
`

`

`Case: 23-1509 Document: 35 Page: 2 Filed: 07/14/2023
`
`PATENT CLAIMS AT ISSUE
`U.S. Patent No. 9,572,499 – Claim 11
`
`11. A system for determining the presence of an arrhythmia of a first user,
`comprising
`
`a heart rate sensor coupled to said first user;
`
`a mobile computing device comprising a processor, wherein said mobile
`computing device is coupled to said heart rate sensor, and wherein said mobile
`computing device is configured to sense an electrocardiogram of said first
`user; and
`
`a motion sensor
`
`a non-transitory computer readable medium encoded with a computer
`program including instructions executable by said processor to cause said
`processor to receive a heart rate of said first user from said heart rate sensor,
`sense an activity level of said first user from said motion sensor, determine a
`heart rate variability of said first user based on said heart rate of said first user,
`compare said activity level of said first user to said heart rate variability of
`said first user, and alert said first user to record an electrocardiogram using
`said mobile computing device.
`
`U.S. Patent No. 9,572,499 – Dependent Claim 16
`
`16.
`
`The system of claim 11, wherein said mobile computing device comprises a
`smartwatch.
`
`U.S. Patent No. 9,572,499 – Dependent Claim 17
`
`17.
`
`The system of claim 11, wherein said computer program further causes said
`processor to determine a presence of said arrhythmia using a machine learning
`algorithm.
`
`i
`
`

`

`Case: 23-1509 Document: 35 Page: 3 Filed: 07/14/2023
`
`U.S. Patent No. 10,638,941 – Claim 12
`
`12. A smartwatch, comprising
`
`
`a processor;
`
`
`
`a first sensor configured to sense an activity level value of a user, wherein the
`first sensor is coupled to the processor;
`
` a
`
` photoplethysmogram (“PPG”) sensor configured to sense a heart rate
`parameter of the user when the activity level value is resting, wherein the PPG
`sensor is coupled to the processor;
`
`an electrocardiogram (“ECG”) sensor configured to sense electrical signals of
`a heart, wherein the ECG sensor comprises a first electrode and a second
`electrode, and wherein the ECG sensor is coupled to the processor; and
`
` a
`
` non-transitory computer readable storage medium encoded with a computer
`program including instructions executable by the processor to cause the
`processor to:
`
`
`determine if a discordance is present between the activity level value of
`the user and the heart rate parameter of the user;
`
`based on the presence of the discordance, indicate to the user a possibility
`of an arrhythmia being present; and
`
`receive electric signals of the user from the ECG sensor to confirm the
`presence of the arrhythmia.
`
`U.S. Patent No. 10,595,731 – Claim 1
`
`1.
`
`
`A smart watch to detect the presence of an arrhythmia of a user, comprising
`
`a processing device;
`
` a
`
` photoplethysmography (“PPG”) sensor operatively coupled to the
`processing device;
`
`
`
`
`ii
`
`

`

`Case: 23-1509 Document: 35 Page: 4 Filed: 07/14/2023
`
`an ECG sensor, comprising two or more ECG electrodes, the ECG sensor
`operatively coupled to the processing device;
`
` display operatively coupled to the processing device; and
`
` a
`
` a
`
` memory, operatively coupled to the processing device, the memory having
`instructions stored thereon that, when executed by the processing device,
`cause the processing device to:
`
`
`receive PPG data from the PPG sensor;
`
`detect, based on the PPG data, the presence of an arrhythmia;
`
`receive ECG data from the ECG sensor; and
`
`confirm the presence of the arrhythmia based on the ECG data.
`
`
`
`
`
`iii
`
`

`

`Case: 23-1509 Document: 35 Page: 5 Filed: 07/14/2023
`
`FORM 9. Certificate of Interest
`
`Form 9 (p. 1)
`March 2023
`
`UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`CERTIFICATE OF INTEREST
`
`Case Number
`Short Case Caption
`Filing Party/Entity
`
`23-1509, 23-1553
`AliveCor, Inc. v. Apple Inc.
`AliveCor, Inc.
`
`Instructions:
`
`1. Complete each section of the form and select none or N/A if appropriate.
`
`2. Please enter only one item per box; attach additional pages as needed, and
`check the box to indicate such pages are attached.
`
`3. In answering Sections 2 and 3, be specific as to which represented entities
`the answers apply; lack of specificity may result in non-compliance.
`
`4. Please do not duplicate entries within Section 5.
`
`5. Counsel must file an amended Certificate of Interest within seven days after
`any information on this form changes. Fed. Cir. R. 47.4(c).
`
`I certify the following information and any attached sheets are accurate and
`complete to the best of my knowledge.
`
`07/14/2023
`Date: _________________
`
`Signature:
`
`/s/ Sean S. Pak
`
`Name:
`
`Sean S. Pak
`
`iv
`
`

`

`Case: 23-1509 Document: 35 Page: 6 Filed: 07/14/2023
`
`FORM 9. Certificate of Interest
`
`1. Represented
`Entities.
`Fed. Cir. R. 47.4(a)(1).
`Provide the full names of
`all entities represented by
`undersigned counsel
`in
`this case.
`
`Form 9 (p. 2)
`March 2023
`
`2. Real Party in
`Interest.
`Fed. Cir. R. 47.4(a)(2).
`Provide the full names of
`all real parties in interest
`for the entities. Do not list
`the real parties if they are
`the same as the entities.
`
`3. Parent Corporations
`and Stockholders.
`Fed. Cir. R. 47.4(a)(3).
`Provide the full names of
`all parent corporations for
`the
`entities and all
`publicly held companies
`that own 10% or more
`stock in the entities.
`(cid:1798) None/Not Applicable (cid:1798) None/Not Applicable
`
`✔
`
`AliveCor, Inc.
`
`OMROM Corp.
`
`(cid:1798) Additional pages attached
`
`v
`
`

`

`Case: 23-1509 Document: 35 Page: 7 Filed: 07/14/2023
`
`FORM 9. Certificate of Interest
`
`Form 9 (p. 3)
`March 2023
`
`✔
`
`4. Legal Representatives. List all law firms, partners, and associates that (a)
`appeared for the entities in the originating court or agency or (b) are expected to
`appear in this court for the entities. Do not include those who have already entered
`an appearance in this court. Fed. Cir. R. 47.4(a)(4).
`(cid:1798) None/Not Applicable
`(cid:1798) Additional pages attached
`Quinn Emanuel Urquhart
`& Sullivan, LLP
`
`S. Alex Lasher
`
`Andrew Holmes
`
`Adam B. Wolfson
`
`Phillip Ducker
`
`Peter Benson
`
`Brian Saunders
`
`Catherine R. Lacey
`
`John W. McCauley
`
`✔
`
`5. Related Cases. Other than the originating case(s) for this case, are there
`related or prior cases that meet the criteria under Fed. Cir. R. 47.5(a)?
`(cid:1798) Yes (file separate notice; see below) (cid:1798) No (cid:1798) N/A (amicus/movant)
`If yes, concurrently file a separate Notice of Related Case Information that complies
`with Fed. Cir. R. 47.5(b). Please do not duplicate information. This separate
`Notice must only be filed with the first Certificate of Interest or, subsequently, if
`information changes during the pendency of the appeal. Fed. Cir. R. 47.5(b).
`
`6. Organizational Victims and Bankruptcy Cases. Provide any information
`required under Fed. R. App. P. 26.1(b) (organizational victims in criminal cases)
`and 26.1(c) (bankruptcy case debtors and trustees). Fed. Cir. R. 47.4(a)(6).
`(cid:1798) None/Not Applicable
`(cid:1798) Additional pages attached
`
`✔
`
`vi
`
`

`

`Case: 23-1509 Document: 35 Page: 8 Filed: 07/14/2023
`
`Attachment to AliveCor’s Certificate of Interest
`
`4. Legal Representatives. List all law firms, partners, and associates that (a) appeared for the
`entities in the originating court or agency or (b) are expected to appear in this court for the
`entities. Do not include those who have already entered an appearance in this court. Fed. Cir. R.
`47.4(a)(4).
`
`(cont.)
`
`Kevin Gu
`Michelle Clark
`James Glass
`Matt Hosen
`Bruce Lee
`Richard Doss
`Isabel Peraza
`Evan Larson
`Haihang Wang
`Joshua Scheufler
`James Darling
`Scott Watson
`Robin McGrath
`Stephen Klapper
`Nicolas Siebert
`Krishna Shah
`John McKee
`Nicholas Caluda
`Lora Green
`
`vii
`
`

`

`Case: 23-1509 Document: 35 Page: 9 Filed: 07/14/2023
`
`TABLE OF CONTENTS
`
`Page
`CERTIFICATE OF INTEREST ............................................................................... iv 
`TABLE OF AUTHORITIES ..................................................................................... x 
`STATEMENT OF RELATED CASES ................................................................. xiii 
`PRELIMINARY STATEMENT ............................................................................... 1 
`JURISDICTIONAL STATEMENT .......................................................................... 3 
`STATEMENT OF THE ISSUES............................................................................... 4 
`STATEMENT OF THE CASE .................................................................................. 4 
`A.  AliveCor’s Patents And Domestic Industry Products Practicing
`Those Patents ......................................................................................... 4 
`1. 
`The AFib Problem ....................................................................... 5 
`2. 
`AliveCor’s Patents ...................................................................... 7 
`(a) 
`The ’499 And ’731 Patents ............................................... 9 
`(b) 
`The ’941 Patent ............................................................... 12 
`Domestic Industry Products ...................................................... 14 
`3. 
`AliveCor’s Investments In The Domestic Industry Products ............. 19 
`Apple’s Accused Products And Features ............................................ 21 
`The Commission Proceedings ............................................................. 25 
`1. 
`The Claim Construction Order.................................................. 26 
`2. 
`The ALJ’s Initial Determination ............................................... 26 
`3. 
`The Commission’s Final Determination ................................... 31 
`SUMMARY OF The ARGUMENT ........................................................................ 34 
`STANDARD OF REVIEW ..................................................................................... 36 
`ARGUMENT ........................................................................................................... 38 
`I. 
`THE COMMISSION ERRED IN DETERMINING THAT CLAIMS
`16 AND 17 OF THE ’499 PATENT ARE INVALID UNDER 35
`U.S.C. § 101 ................................................................................................... 38 
`A. 
`The Claims Are Not Directed To Abstract Ideas ................................ 39 
`B. 
`The Claims Contain Inventive Concepts ............................................. 46 
`
`B. 
`C. 
`D. 
`
`
`
`viii
`
`

`

`Case: 23-1509 Document: 35 Page: 10 Filed: 07/14/2023
`
`II. 
`
`B. 
`
`THE COMMISSION ERRED IN DETERMINING THAT THE
`ACCUSED PRODUCTS DO NOT INFRINGE CLAIMS 16 AND 17
`OF THE ’499 PATENT ................................................................................. 52 
`A. 
`The Commission’s Late-Breaking Construction Of The “Alert”
`Limitation Was Erroneous .................................................................. 53 
`The Commission’s Noninfringement Finding Is Not Supported
`By Substantial Evidence ...................................................................... 56 
`1. 
`The Accused Products Literally Infringe .................................. 57 
`2. 
`The Accused Products Infringe Under The Doctrine Of
`Equivalents ................................................................................ 62 
`CONCLUSION ........................................................................................................ 64 
`ADDENDUM
`CERTIFICATE OF COMPLIANCE
`
`Statement Regarding Confidential Material Omitted
`
`
`
`Pursuant to Federal Circuit Rule 25.1(e) and the Protective Order issued in the
`
`International Trade Commission on May 26, 2021, and amended on August 18,
`
`2021, AliveCor, Inc. is filing a confidential version of this brief that highlights the
`
`material marked confidential, and a non-confidential version including appropriate
`
`redactions. In the non-confidential version of this brief, confidential material has
`
`been deleted on pages 16, 18, 19, 20, 21, 25, 30, 31, 59, 60. The general nature of
`
`the deleted material is (1) confidential business information of AliveCor, Inc.
`
`regarding its finances, product information, and agreements with a third party not
`
`involved in this litigation; and (2) confidential business information of Apple Inc.
`
`regarding its internal communications and product information.
`
`
`
`ix
`
`

`

`Case: 23-1509 Document: 35 Page: 11 Filed: 07/14/2023
`
`
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Affinity Labs of Tex., LLC v. DIRECTV, LLC,
`838 F.3d 1253 (Fed. Cir. 2016) .......................................................................... 49
`Ajinomoto Co. v. Int’l Trade Comm’n,
`597 F.3d 1267 (Fed. Cir. 2010) .......................................................................... 36
`Alice Corp. Pty. v. CLS Bank Int’l,
`573 U.S. 208 (2014) ...................................................................................... 38, 47
`BASCOM Glob. Internet Servs., Inc. v. AT&T Mobility LLC,
`827 F.3d 1341 (Fed. Cir. 2016) .................................................................... 47, 50
`Berkheimer v. HP Inc.,
`881 F.3d 1360 (Fed. Cir. 2018) .......................................................................... 37
`Bio-Rad Labs., Inc. v. Int’l Trade Comm’n,
`998 F.3d 1320 (Fed. Cir. 2021) .......................................................................... 37
`CardioNet, LLC v. InfoBionic, Inc.,
`955 F.3d 1358 (Fed. Cir. 2020) .................................................37, 40, 41, 42, 44
`Enfish, LLC v. Microsoft Corp.,
`822 F.3d 1327 (Fed. Cir. 2016) .......................................................................... 44
`Graco, Inc. v. Binks Mfg. Co.,
`60 F.3d 785 (Fed. Cir. 1995) ........................................................................ 52, 53
`Guangdong Alison Hi-Tech Co. v. Int’l Trade Comm’n,
`936 F.3d 1353 (Fed. Cir. 2019) .................................................................... 36, 37
`Intellectual Ventures I LLC v. Capital One Bank (USA),
`792 F.3d 1363 (Fed. Cir. 2015) .......................................................................... 49
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995) .............................................................................. 52
`Mayo Collaborative Services v. Prometheus Labs., Inc.,
`566 U.S. 66 (2012) ........................................................................................ 47, 50
`
`
`
`x
`
`

`

`Case: 23-1509 Document: 35 Page: 12 Filed: 07/14/2023
`
`
`
`McRO, Inc. v. Bandai Namco Hames Am. Inc.,
`837 F.3d 1299 (Fed. Cir. 2016) .............................................................. 34, 39, 43
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .................................................... 54, 55
`SAS Inst., Inc. v. ComplementSoft, LLC,
`825 F.3d 1341 (Fed. Cir. 2016), rev’d on other grounds sub nom.
`SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348 (2018) ................................................. 56
`Synopsys, Inc. v. Mentor Graphics Corp.,
`839 F.3d 1138 (Fed. Cir. 2016) .................................................................... 46, 47
`Tinnus Enterprises, LLC v. Telebrands Corp.,
`846 F.3d 1190, 1204 (Fed. Cir. 2017) ............................................................... 58
`Warner-Jenkinson Co. v. Hilton Davis Chemical Co.,
`520 U.S. 17 (1997) ........................................................................................ 62, 63
`Wilson Sporting Goods Co. v. Hillerich & Bradsby Co.,
`442 F.3d 1322 (Fed. Cir. 2006) .......................................................................... 55
`Statutes
`5 U.S.C. § 706(2) ..................................................................................................... 36
`19 U.S.C. § 1337 ................................................................. 1, 3, 4, 25, 26, 31, 34, 64
`19 U.S.C. § 1337(a)(3)(C) ....................................................................................... 30
`19 U.S.C. § 1337(b)(1)............................................................................................... 3
`19 U.S.C. § 1337(c) ............................................................................................. 3, 36
`28 U.S.C. § 1295(a)(6) ............................................................................................... 3
`35 U.S.C. § 101 ......................................... 2, 4, 27, 28, 29, 31, 32, 34, 35, 37, 38, 48
`35 U.S.C. § 103 .................................................................................................. 27, 31
`
`
`
`xi
`
`

`

`Case: 23-1509 Document: 35 Page: 13 Filed: 07/14/2023
`
`
`
`Other Authorities
`Taking an ECG with the ECG app on Apple Watch Series, APPLE
`(Dec. 18, 2018),
`https://web.archive.org/web/20181218032238/https://support.apple
`.com/en-us/HT208955 ........................................................................................ 58
`
`
`
`
`
`
`xii
`
`

`

`Case: 23-1509 Document: 35 Page: 14 Filed: 07/14/2023
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`
`
`
`
`STATEMENT OF RELATED CASES
`This consolidated appeal may affect or be affected by AliveCor’s pending
`
`appeal from the Patent Trial and Appeal Board’s decisions involving the same
`
`patents. See AliveCor, Inc. v. Apple Inc., Nos. 23-1512, -1513, -1514.
`
`
`
`In addition, this appeal may affect the pending district-court litigation in
`
`which AliveCor has asserted against Apple the same patents at issue in this appeal.
`
`See AliveCor, Inc. v. Apple Inc., No. 20-cv-1112 (W.D. Tex.). That litigation is
`
`stayed pending resolution of this conslidated appeal from the International Trade
`
`Commission’s decision. See id., Order, Dkt. 26 (May 6, 2021).
`
`
`
`
`
`xiii
`
`

`

`Case: 23-1509 Document: 35 Page: 15 Filed: 07/14/2023
`
`
`
`PRELIMINARY STATEMENT
`When AliveCor, Inc. released the KardiaBand System in 2017, it
`
`revolutionized the way consumers could monitor their heart health. By combining
`
`photoplethysmography (“PPG”), electrocardiogram (“ECG”), and motion sensors
`
`with sophisticated machine-learning algorithms that ran on the Apple Watch,
`
`AliveCor’s patented invention allowed users to detect and confirm the presence of
`
`arrhythmias like atrial fibrillation (“AFib”)—a condition that kills millions of
`
`Americans each year—with a convenient and accessible device. Yet soon after
`
`AliveCor commercialized its landmark achievement, Apple anticompetively killed
`
`off the KardiaBand System to pave the way for its own competing (and infringing)
`
`Irregular Rhythm Notification (“IRN”) and ECG features, which Apple released in
`
`late 2018.
`
`AliveCor sought to vindicate its rights before the International Trade
`
`Commission, which correctly found that certain versions of the Apple Watch
`
`infringed valid claims from two of three asserted patents (U.S. Patent No.
`
`10,595,731 (the “’731 patent”) and U.S. Patent No. 10,638,941 (the “’941 patent”))
`
`and issued an exclusion order under section 337 of the Tariff Act of 1930, 19 U.S.C.
`
`§ 1337 (“Section 337”), that is suspended pending a separate, companion appeal
`
`regarding the validity of those claims. The Commission’s determination that claims
`
`of a third AliveCor patent (U.S. Patent No. 9,572,499 (the “’499 patent”)) were
`
`
`
`
`1
`
`

`

`Case: 23-1509 Document: 35 Page: 16 Filed: 07/14/2023
`
`
`
`invalid and not infringed, however, rested on several legal and factual errors that
`
`warrant reversal.
`
`First, the Commission erred in ruling that certain claims of the ’499 patent are
`
`invalid under 35 U.S.C. § 101. At step one of the § 101 analysis, the Commission
`
`erroneously determined that the claims are directed to abstract ideas, even though
`
`the claim language, the specification, and expert testimony all show that the claims
`
`are directed to specific improvements in cardiac monitoring technology. The
`
`Commission compounded its error by concluding that the claims lacked inventive
`
`concepts sufficient to render them patent-eligible at step two. In so ruling, the
`
`Commission disregarded evidence that the claimed inventions were unconventional
`
`and instead imposed its own unsupported view of future technologies that the claims
`
`might preempt.
`
`Second, the Commission erred in ruling that Apple did not infringe those same
`
`claims, relying on a late-breaking claim construction that conflicted with the ALJ’s
`
`prior Markman order. In that order, the ALJ had given the term “alert,” which is
`
`required by all asserted claims of the ’499 patent, its plain and ordinary meaning,
`
`“not limited to a message, ”while also explaining that the claims of the ’499 patent
`
`are directed to “determining whether or not an ECG is appropriate, and then
`
`‘alerting’ a user to that fact.” Appx322-323. But in finding no infringement, the
`
`Commission applied a new construction of the term “alert” that requires a literal,
`
`
`
`
`2
`
`

`

`Case: 23-1509 Document: 35 Page: 17 Filed: 07/14/2023
`
`
`
`text-based “alert” to the user to record an ECG. Had the Commission applied the
`
`original—and correct—construction, it would have found that the alert message
`
`from Apple’s IRN feature, which appears on the face of the Apple Watch (as well
`
`as the paired iPhone), “alerts” the user to an opportune time to take an ECG on the
`
`Apple Watch to capture the presence of an arrythmia, as required by the claim.
`
`Indeed, the undisputed record shows that the sudden nature of the IRN “alert,” which
`
`may surface when the user has experienced no discernible cardiac symptoms and
`
`has no history of AFib, would be so alarming that it would likely cause the user to
`
`take responsive action, including by voluntarily recording an ECG using the Apple
`
`Watch’s ECG App, in accordance with Apple’s own public instructions and designs.
`
`For these reasons and as more fully explained below, the Court should reverse
`
`the Commission’s erroneous determination with respect to the ’499 patent.
`
`JURISDICTIONAL STATEMENT
`The Commission had jurisdiction of the underlying investigation pursuant to
`
`19 U.S.C. § 1337(b)(1). The Commission issued a final determination on December
`
`22, 2022, finding that Apple violated Section 337 through infringement of the ’941
`
`and ’731 patents, but not with respect to the ’499 patent. Appx1-89. The
`
`Commission’s determination as to the ’499 patent became final upon issuance, and
`
`AliveCor timely filed a notice of appeal on February 7, 2023. Dkt. 1. This Court
`
`has jurisdiction under 19 U.S.C. § 1337(c) and 28 U.S.C. § 1295(a)(6).
`
`
`
`
`3
`
`

`

`Case: 23-1509 Document: 35 Page: 18 Filed: 07/14/2023
`
`
`
`STATEMENT OF THE ISSUES
`1. Whether the Commission erred in determining that Apple did not
`
`violate Section 337 on the basis that claims 16 and 17 of the ’499 patent are invalid
`
`for lack of patentable subject matter under 35 U.S.C. § 101.
`
`2. Whether the Commission erred in determining that Apple did not
`
`violate Section 337 on the basis that AliveCor failed to prove that Apple’s products
`
`infringe claims 16 or 17 of the ’499 patent.
`
`STATEMENT OF THE CASE
`A. AliveCor’s Patents And Domestic Industry Products Practicing
`Those Patents
`AliveCor is a California corporation that is a pioneer in developing life-saving
`
`mobile health devices. Appx30053-30054. Since its inception, AliveCor has pushed
`
`the reach of medical services and technology beyond the doctor’s office.
`
`Appx30053-30054. Its co-founder and Chief Medical Officer, Dr. David Albert,
`
`was inspired to begin his life’s work of improving cardiac monitoring technology
`
`after his father suffered a heart attack and was prescribed a daily exercise regimen
`
`of walking until he maintained a heart rate of 120 beats per minute. Appx30044-
`
`30046. The problem was that, in 1980, heart-rate monitors were nowhere to be
`
`found. Appx30045. AliveCor has since filled that void through commercialized,
`
`clinically validated cardiac monitoring technology packaged in portable, easy-to-use
`
`
`
`
`4
`
`

`

`Case: 23-1509 Document: 35 Page: 19 Filed: 07/14/2023
`
`
`
`devices, ranging from wrist-worn watch bands to credit-card-sized readers.
`
`Appx30053-30054; Appx30100.
`
`1.
`The AFib Problem
`The issue Dr. Albert confronted in 1980 was—and still is—a serious problem:
`
`Heart disease kills millions of Americans each year. Appx30046. Treatment can
`
`prevent many of these deaths, but only if the underlying heart conditions can be
`
`detected and diagnosed. Appx31232-31235. One of the most common forms of
`
`heart disease is cardiac arrhythmia—“a cardiac condition in which the electrical
`
`activity of the heart is irregular or is faster or slower than normal.” Appx318-319;
`
`see Appx126-127.
`
`There are many kinds of arrhythmias, the most common of which is AFib—a
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`condition likely affecting over six million Americans. Appx30049-30050;
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`Appx31215-31217. This estimate, however, is imprecise because AFib is difficult
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`to detect and diagnose. Particularly in the early stages of the disease, AFib is often
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`paroxysmal, meaning that many episodes of “irregular” rhythms come and go
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`between lengthy periods of normal rhythms. Appx30049-30051. And AFib is
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`asymptomatic in up to forty percent of cases, even during episodes. Appx30050.
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`Because AFib is elusive, many patients never know that they have it until the disease
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`has progressed and serious symptoms surface. Appx30049-30050. Advanced AFib
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`results in a fivefold to sixfold increase in the risk of a serious stroke. Appx30049-
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`30050.
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`In clinical settings, doctors diagnose AFib using a 12-lead electrocardiogram,
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`or “12-lead ECG.” Appx30048-30049. An ECG uses several electrodes attached to
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`strategic points on the patient that capture the heart’s electrical activity from various
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`angles. Appx30048-30049. A 12-lead ECG offers twelve different views of the
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`heart. Appx30048-30049. It is considered the “gold-standard” of AFib diagnostics.
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`Appx30048-30049; see Appx13934-13935 (news article stating that a “standard
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`ECG remains the gold standard for detecting AFib”).
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`In a patient experiencing an episode of AFib, a 12-lead ECG will produce
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`ECG waveforms with certain characteristics. Appx30049. In AFib patients, the “P-
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`wave,” which represents the electrical activation (i.e., depolarization) of the right
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`and left atria, will be flattened or less pronounced than those in ECG recordings from
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`healthy patients experiencing “normal sinus rhythm.” Appx30049; Appx30290-
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`30292. In addition, the sequencing of QRS complexes, which represent the
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`activation of the right and left ventricles, will often be more irregular in patients with
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`AFib. Appx30049. In medical practice, this often manifests as an “irregularly
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`irregular” heart rhythm, meaning that the timing between successive heartbeats will
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`vary over a given period. Appx30049. Using conventional diagnostic methods
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`(mainly 12-lead ECG recordings), doctors can sometimes successfully diagnose
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`AFib, and then begin treatment. Appx30048-30050.
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`While the 12-lead ECG is effective, not all patients will exhibit signs of AFib
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`during a medical examination, such as patients with paroxysmal AFib, whose
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`detectable AFib episodes may come and go. Appx30049-30050; Appx31235-
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`31236. Worse still, some patients may not notice any symptoms at all during
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`episodes, such as patients with asymptomatic AFib. Appx30049-30050. In these
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`circumstances, a 12-lead ECG has limited value. Appx30049-30050; Appx31235-
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`31236.
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`2.
`AliveCor’s Patents
`AliveCor recognized this long-standing problem with the traditional, clinical
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`method of diagnosing AFib and set out to solve it. While a 12-lead ECG device is
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`the most accurate at detecting AFib when captured during an episode, it cannot
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`remain attached to a person at all times. Appx31235-31236. AliveCor realized that
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`another type of sensor—PPG sensors—can be so attached. Appx30292-30293. PPG
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`sensors shine light at the skin and measure the light reflected back at the sensor to
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`determine how much light is absorbed by blood volume, which varies as the heart
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`beats and blood flows. Appx30066. This technique can be used to extract features
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`like heart rate. Appx30066. PPG sensors fit easily in portable devices, like a
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`smartwatch, permitting continuous background monitoring of the user’s heart “that
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`requires no activity on the part of the user.” Appx30066. PPG monitoring can
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`reliably measure oxygen saturation and average heart rate, but is less reliable in
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`detecting arrhythmias, such as AFib. Appx31236-31237. In addition, PPG readings
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`can be disrupted by, for example, the user’s motion and elevated heart rates caused
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`by normal exercise. Appx31240-31241. Motion sensors, however, can account for
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`these degrading effects and reduce false positives. Appx31240-31241. And while
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`these sensors can provide valuable data indicating the presence of arrhythmias, the
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`use of sophisticated machine-learning algorithms permits detection and
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`confirmation of these conditions in real time, without the need for a medical
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`professional to analyze the sensor data. Appx31201-31202; Appx31243-31245.
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`AliveCor’s novel solution was to use PPG and ECG—with the assistance of activity
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`sensors and machine learning algorithms—in combination to cover up the
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`weaknesses of each one in isolation, thereby better detecting AFib.
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`The three AliveCor patents at issue here thus teach detection of an arrhythmia
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`via the less-intrusive, background-monitoring PPG and motion sensors and
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`confirmation of the arrhythmia using the more accurate but more burdensome ECG
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`sensor when the algorithms analyzing data from the PPG and motion sensors
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`determine that it is appropriate to do so. Appx30292-30293. The ’499 and ’731
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`patents also teach applying machine learning algorithms to the PPG sensor to train
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`and improve its ability to detect arrhythmias, before alerting the user to take a second
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`measurement using an ECG sensor. Appx30294.
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`(a) The ’499 And ’731 Patents
`The ’499 and ’731 patents are both titled “Methods and systems for
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`arrhythmia tracking and scoring,” and share the same specification. Appx10002-
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`Appx10040 (’499 patent); Appx10042-10073 (’731 patent). The specification notes
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`that conventional ambulatory ECG devices, such as Holter monitors, “are typically
`
`bulky and difficult for subjects to administer without the aid of a medical
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`professional.” Appx10026 (1:57-60). The specification teaches that, while using
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`the claimed invention, “[a]n advisory condition for recording an ECG” can occur
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`“when a measured heart rate increases rapidly without a corresponding increase in
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`activity.” Appx10038 (25:19-21). “By comparing measured heart rate changes with
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`measured activity changes, the presently disclosed software or ‘app’ minimizes false
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`alarms.” Appx10038 (25:22-24).
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`The claims of the ’499 and ’731 patents are similar, but have slight
`
`differences. Unasserted, independent claim 11 of the ’499 patent recites:
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`11. A system for determining the presence of an arrhythmia of a first user,
`comprising
`
`
`
`a heart rate sensor coupled to said first user;
`
` a
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` mobile computing device comprising a processor, wherein said
`mobile computing device is coupled to said heart rate sensor,