CONTAINS CONFIDENTIAL BUSINESS INFORMATION -- SUBJECT TO PROTECTIVE ORDER
`CONTAINS SOURCE CODE – ATTORNEYS’ EYES ONLY INFORMATION
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Cameron R. Elliot
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
`
`Inv. No. 337-TA-1266
`
`APPLE INC.’S POST-HEARING BRIEF
`
`APPLE 1084
`Apple v. AliveCor
`IPR2021-00970
`
`1
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`I.
`
`INTRODUCTION ............................................................................................................................. 1
`
`A. Procedural History ............................................................................................................................ 1
`
`B. The Parties ......................................................................................................................................... 2
`
`1. Complainant AliveCor, Inc. ...................................................................................................... 2
`
`2. Respondent Apple Inc. ............................................................................................................. 2
`
`3. Overview of the Technology .................................................................................................... 3
`
`4. Methods and Tools to Monitor a Patient’s Heart ................................................................. 4
`
`5. PPG Technology ........................................................................................................................ 5
`
`6. ECG Technology ....................................................................................................................... 5
`
`C. The Patents in Suit ............................................................................................................................ 6
`
`1. The Asserted Claims .................................................................................................................. 6
`
`2. The ’941 Patent .......................................................................................................................... 6
`
`3. The ’499 and ’731 Patents ......................................................................................................... 7
`
`4. The Preambles of the ’941 and ’731 Patents Are Limiting .................................................. 8
`
`D. The Products at Issue ..................................................................................................................... 10
`
`1. Apple’s High Heart Rate Notification (HHRN) ................................................................. 10
`
`2. Apple’s Irregular Rhythm Notification (IRN) ..................................................................... 11
`
`3. Apple’s ECG App .................................................................................................................... 13
`
`4. Apple’s Usage Statistics ........................................................................................................... 14
`
`JURISDICTION ................................................................................................................................ 15
`II.
`III. RELEVANT LEGAL STANDARDS ........................................................................................... 15
`IV. PATENT NO. 10,595,941................................................................................................................ 15
`
`A. Non-infringement of the ’941 Patent .......................................................................................... 15
`
`1. IRN Does Not Infringe Claim 12(f)(i)-(ii) of the ’941 Patent Because it Does Not
`Determine a Discordance ....................................................................................................... 17
`
`2. HHRN Does Not “Based On the Presence of The Discordance, Indicate to the User a
`Possibility of an Arrhythmia Being Present” under Claim 12(f)(ii) of the ’941 patent .. 21
`
`3. Apple Watch Does Not Infringe Claim 12(f)(iii) Because It Does Not “Confirm the
`Presence of the Arrhythmia” ................................................................................................... 26
`
`a. ECG App Does Not Record or Analyze ECG Data Overlapping in Time with
`PPG Data Associated with the Arrhythmia ............................................................... 28
`
`b. There Are No Inputs from PPG or Processed Versions of PPG, to the ECG
`App Algorithm ............................................................................................................... 29
`
`c. Apple’s Documents Show that ECG App Operates Independently from IRN or
`HHRN ............................................................................................................................. 31
`
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`d. Dr. Jafari’s Expansive Interpretation of “to Confirm” Goes Against the Plain
`Meaning, and Provides a Limitless Time for the System May Confirm a
`Generalized Condition .................................................................................................. 32
`
`e. AliveCor’s Cited Evidence Fails to Show that Apple Watch’s ECG App
`Confirms the Arrhythmia ............................................................................................. 35
`
`4. No Infringement of Dependent Claims 13, 19, 20, 21, 22, and 23 .................................. 39
`
`B. No Technical Industry (KardiaBand,
`
`) ...... 39
`
`1. KardiaBand (KBS) ................................................................................................................... 40
`
`a. KBS does not practice claim 12 of the ’941 patent (or its dependents) ................ 41
`
`b. KBS does not “based on the presence of the discordance, indicate to the user the
`possibility of an arrhythmia” ........................................................................................ 42
`
`c. KBS does not “receive electric signals of the user to confirm the presence of the
`arrhythmia” ..................................................................................................................... 42
`
`d. KBS does not practice dependent claims 16, 20, 22, 21, 22 or 23 ......................... 43
`
`2.
`
`3.
`
` ...................................................................................... 44
`
` ........................................................................................................... 48
`
`C. Invalidity of the ’941 Patent .......................................................................................................... 54
`
`1. Patent-Ineligible Subject Matter ............................................................................................. 54
`
` Alice Step One: Claim 12 Is Directed to Longstanding Arrhythmia Diagnostic
`Processes and Does Not Recite Any Specific Improvements in Cardiac
`Monitoring Devices ....................................................................................................... 54
`
` Alice Step Two: The Claims Contain Only Well-Known, Routine, and
`Conventional Elements that Fail to Provide Any Inventive Concept ................... 57
`
` The Asserted Dependent Claims Are Not Patent Eligible ...................................... 59
`
`2. Obviousness Under 35 U.S.C. § 103: AMON, Almen, and/or Kotzin ........................... 60
`
`a. For Obviousness, AMON, Almen, and Kotzin Need Only Be Enabled When
`Taken as a Whole, to a Person of Ordinary Skill, at the Time of the Challenged
`Invention ......................................................................................................................... 62
`
`b. Motivation to Combine AMON, Almen, and Kotzin ............................................. 65
`
`c. Claim 12 .......................................................................................................................... 67
`
` 12[pre]: 12. A smartwatch, comprising: ............................................................... 67
`
` 12[a]: a processor; .................................................................................................... 68
`
` 12[b]: a first sensor configured to sense an activity level value of a user,
`wherein the first sensor is coupled to the processor; ........................................ 68
`
` 12[c]: 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; ........................................................... 68
`
` 12[d]: an electrocardiogram (“ECG”) sensor configured to sense electrical
`signals of a heart, wherein the ECG sensor comprises a first electrode and a
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`second electrode, and wherein the ECG sensor is coupled to the processor;
`and ............................................................................................................................. 69
`
` 12[e]: 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; ........ 69
`
` 12[f]: based on the presence of the discordance, indicate to the user a
`possibility of an arrhythmia being present .......................................................... 70
`
` 12[g]: receive electric signals of the user from the ECG sensor to confirm the
`presence of the arrhythmia. ................................................................................... 71
`
`d. Claim 13: The smartwatch [] according to claim 12, wherein the heart rate
`parameter comprises an indication of a [HRV], and wherein the arrhythmia is
`atrial fibrillation. ............................................................................................................. 72
`
`e. Claim 16: The smartwatch or wristlet according to claim 12, wherein indicating
`to the user further comprises: instructing the user to record an ECG using the
`ECG sensor. ................................................................................................................... 74
`
`f. Claim 18: The smartwatch according to claim 12, wherein the heart rate
`parameter is a PPG signal. ............................................................................................ 74
`
`g. Claim 19: The smartwatch according to claim 18, wherein the heart rate
`parameter is a heartrate variability (“HRV”) value, wherein the HRV value is
`derived from the PPG signal. ....................................................................................... 74
`
`h. Claim 20: The smartwatch according to claim 18, wherein the heart rate
`parameter is a heartrate, wherein the heartrate is derived from the PPG signal. . 75
`
`i. Claim 21: The smartwatch according to claim 12, the processor further to:
`display an ECG rhythm strip from the electric signals. ........................................... 75
`
`j. Claim 22: The smartwatch according to claim 12, wherein the PPG sensor is
`located on a back of the smartwatch. ......................................................................... 76
`
`k. Claim 23: The smartwatch according to claim 12, wherein the first electrode is
`located on the smartwatch where the first electrode contacts a first side of the
`user's body while the user wears the smartwatch, and the second electrode is
`located on the smartwatch where the user must actively contact the second
`electrode with a second side of the user's body opposite from the first side. ...... 76
`
`3. AliveCor’s Secondary Considerations Evidence Do Not Save the Asserted Patents
`From an Obviousness Finding............................................................................................... 76
`
`a. There Is No Nexus Between Alleged Secondary Considerations and the Asserted
`Patents ............................................................................................................................. 77
`
`b. Apple Did Not Copy AliveCor’s Products ................................................................ 77
`
`c. AliveCor Did Not Solve the Long-Felt but Unmet Need for Continuous ECG
`Monitoring in the Outpatient Setting ......................................................................... 80
`
`d. The Commercial Success of the Apple Watch Is in No Way Tied to the Claimed
`Inventions ....................................................................................................................... 81
`
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`e. AliveCor’s Own Licenses Demonstrate the Asserted Patents Are Not Valuable 83
`
`f. No Evidence of Skepticism .......................................................................................... 83
`
`g. No Evidence of Industry Praise .................................................................................. 84
`
`D. Experimental Use Exception ........................................................................................................ 86
`
`V. PATENT NO. 10,595,731................................................................................................................ 87
`
`A. Non-Infringement of the ’731 Patent .......................................................................................... 87
`
`1. AliveCor Has Failed to Establish a Prima Facie Case of Direct Infringement of Claim 1
`
`87
`
`a. HHRN does not “detect, based on the PPG data, the presence of an arrhythmia”
`under claim 1(f)(ii) of the ’731 patent ......................................................................... 87
`
`b. Apple Watch Does Not Infringe Claim 1(f)(iv) Because ECG App, IRN, and
`HHRN Do Not Confirm the Presence of the Arrhythmia Based on the ECG
`Data .................................................................................................................................. 88
`
`2. No Infringement of Dependent Claims 3, 5, 8-10, 12, 15, and 16 ................................... 88
`
`
`B. No Technical Domestic Industry (KardiaBand,
` ................................................................................................................................................... 88
`
`1. KardiaBand (KBS) ................................................................................................................... 88
`
`2.
`
`3.
`
`) ...................................................................................... 90
`
` ........................................................................................................... 90
`
`C. Invalidity of the ‘731 Patent .......................................................................................................... 91
`
`1. Patent-Ineligible Subject Matter ............................................................................................. 91
`
`a. Alice Step One: Claim 1 Is Directed to Longstanding Arrhythmia Diagnostic
`Processes and Does Not Recite Any Specific Improvements in Cardiac
`Monitoring Devices ....................................................................................................... 91
`
`b. Alice Step Two: The Claims Contain Only Well-Known, Routine, and
`Conventional Elements That Fail to Provide Any Inventive Concept .................. 92
`
`c. The Asserted Dependent Claims Are Not Patent Eligible ...................................... 93
`
`2. Obviousness Under 35 U.S.C. § 103: AMON, Almen, and/or Kotzin ........................... 95
`
`a. Motivation to Combine AMON, Almen, and/or Kotzin ....................................... 96
`
`b. Claim 1: ............................................................................................................................ 96
`
` 1[pre]: A smart watch to detect the presence of an arrhythmia of a user,
`comprising: ............................................................................................................... 96
`
` 1[a]: a processing device; ........................................................................................ 96
`
` 1[b]: a photoplethysmography (“PPG”) sensor operatively coupled to the
`processing device; ................................................................................................... 96
`
` i1[c]: an ECG sensor, comprising two or more ECG electrodes, the ECG
`sensor operatively coupled to the processing device; ........................................ 97
`
` 1[d]: a display operatively coupled to the processing device; and .................... 97
`
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` 1[e]: 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; ....................................................................................................................... 97
`
`vii. 1[f]: detect, based on the PPG data, the presence of an arrhythmia; .............. 98
`
`viii. 1[g]: receive ECG data from the ECG sensor; and ........................................... 98
`
`ix. 1[h]: confirm the presence of the arrhythmia based on the ECG data. .......... 98
`
`c. Claim 2: The smart watch of claim 1, further comprising a motion sensor
`operatively coupled to the processing device, wherein to detect the presence of
`the arrhythmia, the processing device is configured to: receive motion sensor
`data from the motion sensor; and determine, from motion sensor data, that the
`user is at rest. .................................................................................................................. 99
`
`d. Claim 3: The smart watch of claim 2, wherein to detect the presence of the
`arrhythmia, the processing device is configured to input the PPG data into a
`machine learning algorithm trained to detect arrhythmias. ..................................... 99
`
`e. Claim 4: The smart watch of claim 2, wherein to detect the presence of the
`arrhythmia, the processing device is configured to: determine heartrate variability
`(“HRV”) data from the PPG data; and detect, based on the HRV data, the
`presence of the arrhythmia ........................................................................................... 99
`
`f. Claim 5: The smart watch of claim 4, wherein to detect the presence of the
`arrhythmia, the processing device is configured to input the HRV data into a
`machine learning algorithm trained to detect arrhythmias. .................................. 100
`
`g. Claim 7: The smart watch of claim 1, wherein the processing device is further
`configured to: extract one or more features from the PPG data; and detect, based
`on the one or more features, the presence of the arrhythmia. ............................. 100
`
`h. Claim 8: The smart watch of claim 7, wherein the one or more features
`correspond to an HRV signal analyzed in a time domain. ................................... 101
`
`i. Claim 9: The smart watch of claim 7, wherein the one or more features comprise
`a nonlinear transform of R-R ratio or R-R ratio statistics with an adaptive
`weighting factor. .......................................................................................................... 102
`
`j. Claim 10: The smart watch of claim 7, wherein the one or more features are
`features of an HRV signal analyzed geometrically. ................................................ 102
`
`k. Claim 12: The smart watch of claim 1, wherein the processing device is further
`configured to generate a notification of the detected arrhythmia. ...................... 103
`
`l. Claim 15: The smart watch of claim 1, the processing device further configured
`to display an ECG rhythm strip from the ECG data. ........................................... 103
`
`m. Claim 16: The smart watch of claim 1, the processing device further to receive
`the ECG data from the ECG sensor in response to receiving an indication of a
`user action. ................................................................................................................... 104
`
`3. AliveCor's Secondary Considerations Evidence Does Not Save the Asserted Patents
`from an Obviousness Finding ............................................................................................. 104
`
`D. Experimental Use Exception ..................................................................................................... 104
`
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`VI. PATENT NO. 9,572,499 ............................................................................................................... 104
`
`A. Non-Infringement of the ’499 Patent ....................................................................................... 104
`
`1. AliveCor Has Failed to Establish a Prima Facie Case of Direct Infringement of Claim
`11 of the ’499 Patent ............................................................................................................. 104
`
`a. IRN Does Not Compare Activity Level to HRV .................................................. 105
`
`b. IRN Does Not Alert a User to Record an ECG .................................................... 106
`
`2. Dependent Claims 16 and 17 – No Infringement Because Apple Does Not Infringe
`Claim 11 .................................................................................................................................. 112
`
`B. No Technical Domestic Industry (
`
`) ................................................................................. 112
`
`C. Invalidity of the ’499 Patent ....................................................................................................... 113
`
`1. Patent Ineligible Subject Matter .......................................................................................... 113
`
`a. Alice Step One: Asserted Claims 16 and 17 Are Directed to Longstanding
`Arrhythmia Diagnostic Processes and Does Not Recite Any Specific
`Improvements in Cardiac Monitoring Devices ...................................................... 113
`
`b. Alice Step Two: Asserted Claims 16 and 17 Contain Only Well-Known, Routine,
`and Conventional Elements That Fail to Provide Any Inventive Concept ....... 114
`
`2. Obviousness Under 35 U.S.C. § 103: AMON, Kotzin and Almen ............................... 115
`
`a. Motivation to Combine AMON, Almen, and Kotzin .......................................... 116
`
`b. Claim 11: ...................................................................................................................... 116
`
` 11[pre]: 11. A system for determining the presence of an arrhythmia of a first
`user, comprising: .................................................................................................. 116
`
` 11[a]: a heart rate sensor coupled to said first user; ........................................ 116
`
` 11[b]: 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 ................................................................................................ 117
`
` 11[c]: a motion sensor; ........................................................................................ 117
`
` 11[d]: 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,
` 117
`
` 11[e]: sense an activity level of said first user from said motion sensor, ..... 118
`
` 11[f]: determine a heart rate variability of said first user, based on said heart
`rate of said first user, ........................................................................................... 118
`
` 11[g]: compare said activity level of said first user to said heart rate variability
`of said first user, ................................................................................................... 119
`
` 11[h]: and alert said first user to record an electrocardiogram using said
`mobile computing device. ................................................................................... 119
`
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`c. Claim 16: The system of claim 11, wherein said mobile computing device
`comprises a smartwatch. ............................................................................................ 120
`
`d. Claim 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. ...................................................................................................... 120
`
`3. AliveCor's Secondary Considerations Evidence Does Not Save the Asserted Patents
`From an Obviousness Finding............................................................................................ 120
`
`D. Experimental Use Exception ..................................................................................................... 120
`
`VII. LACK OF DOMESTIC INDUSTRY – ECONOMIC PRONG .......................................... 120
`
`A. Lack of Existing Domestic Industry at the Time of the Complaint .................................... 122
`
`1. No Existing Domestic Industry with Respect to the
`
` ........................... 126
`
`2. No Existing Domestic Industry with Respect to the KBS ............................................. 129
`
`3. No Significant Investment in Employment of Labor or Capital Under § 1337(a)(3)(B)
`132
`
`
`a. Dr. Akemann’s and AliveCor’s Allocation of AliveCor’s R&D Expenditures in
`KBS Is Unreliable ....................................................................................................... 132
`
`b. AliveCor’s Asserted Regulatory Investments in KBS Are Overstated and
`Unreliable ..................................................................................................................... 135
`
`c. AliveCor’s Asserted Customer Support Investments in KBS Are Overstated and
`Unreliable ..................................................................................................................... 137
`
`d. AliveCor’s Labor and Capital Expenditures Relating to KBS Are Not Significant .
` ................................................................................................................................ 138
`
`
`4. No Significant Investment in Plant and Equipment Under § 1337(a)(3)(A) ............... 139
`
`5. No Substantial Exploitation of Asserted Patents Under § 1337(a)(3)(C) ..................... 141
`
`B. Lack of a Domestic Industry in the Process of Being Established ...................................... 143
`
`1. No Significant Investment in Employment of Labor or Capital Under § 1337(a)(3)(B) ..
` ....................................................................................................................................... 156
`
`
`2. No Significant Investment in Plant and Equipment Under § 1337(a)(3)(A) ............... 161
`
`3. No Substantial Exploitation of Asserted Patents Under § 1337(a)(3)(C) ..................... 162
`
`VIII. REMEDY AND BONDING ................................................................................................... 166
`
`A. Remedy .......................................................................................................................................... 167
`
`B. Bonding ......................................................................................................................................... 170
`
`C. Enforcement ................................................................................................................................. 173
`
`IX. CONCLUSION .............................................................................................................................. 175
`
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`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Cases
`
`Abtox, Inc. v. Exitron Corp.,
`122 F.3d 1019 (Fed. Cir. 1997), opinion amended on reh’g, 131 F.3d 1009 (Fed. Cir.
`1997) ........................................................................................................................................86
`
`Accenture Global Servs., GmbH v. Guidewire Software, Inc.,
`728 F.3d 1336 (Fed.Cir.2013)..................................................................................................58
`
`Alice Corp. Pty. v. CLS Bank Int'l,
`573 U.S. 208 (2014) ......................................................................................................... passim
`
`In re Antor Media Corp.,
`689 F.3d 1282 (Fed. Cir. 2012)................................................................................................63
`
`Apple, Inc. v. Ameranth, Inc.,
`842 F.3d 1229 (Fed. Cir. 2016)................................................................................58, 114, 115
`
`B/E Aero., Inc. v. C&D Zodiac, Inc.,
`962 F. 3d 1373 (Fed. Cir. 2020)...............................................................................................63
`
`Beckman Instruments Inc. v. LKB Produkter AB,
`892 F.2d 1547 (Fed. Cir. 1989)................................................................................................62
`
`Biocraft Labs., Inc. v. ITC,
`947 F.2d 483 (Fed. Cir. 1991)................................................................................................170
`
`In re Board of Trustees of Leland Stanford Junior University,
`991 F.3d at 1252 ......................................................................................................................94
`
`In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig.,
`774 F.3d 755 (Fed. Cir. 2014)..................................................................................................57
`
`buySAFE, Inc. v. Google, Inc.,
`765 F.3d 1350 (Fed. Cir. 2014)................................................................................................58
`
`CardioNet v. InfoBionic, Inc.,
`2021 WL 5024388 (Fed. Cir. Oct. 29, 2021) ...........................................................................57
`
`CardioNet, LLC v. InfoBionic, Inc.,
`816 F. App'x 471 (Fed. Cir. 2020) .....................................................................................55, 56
`
`Catalina Marketing Int’l v. Coolsacings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002)....................................................................................................9
`
`
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`Certain Abrasive Products Made Using a Process for Powder Preforms, and Products
`Containing Same,
`Inv. No. 337-TA-449, 2002 WL 31093610, Comm’n Op. (July 26, 2002) ...........................171
`
`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, 2007 WL 9676556, Comm’n Op. on Remedy, The Public Interest, and
`Bonding (June 7, 2007) ..........................................................................................................167
`
`Certain Carburetors and Products Containing Such Carburetors,
`Inv. No. 337-TA-1123, Comm’n Op., 5-6 (Oct. 28, 2019) ...........................................141, 160
`
`Certain Digital Televisions & Certain Prods. Containing Same & Methods of Using Same,
`Inv. No. 337-TA-617, 2009 WL 1124461, Comm’n Op. (Apr. 23, 2009) ............................169
`
`Certain Digital Video-Capable Devices a