`
`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
`
`EXPERT REPORT OF COLLIN STULTZ, M.D., PH.D. REGARDING INVALIDITY
`
` OF U.S. PATENT NOS. 9,572,499, 10,595,731, AND 10,638,941
`
`
`
`1
`
`APPLE 1081
`Apple v. AliveCor
`IPR2021-00972
`
`
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`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`TABLE OF CONTENTS
`
`
`INTRODUCTION .............................................................................................................. 1
`I.
`QUALIFICATIONS ........................................................................................................... 2
`II.
`III. MATERIALS CONSIDERED ........................................................................................... 4
`IV.
`SUMMARY OF OPINIONS .............................................................................................. 5
`V.
`LEGAL STANDARDS ...................................................................................................... 6
`A.
`Claim Construction ................................................................................................. 6
`B.
`Invalidity ................................................................................................................. 7
`1.
`Ineligible Subject Matter............................................................................. 8
`2.
`Anticipation................................................................................................. 9
`3.
`Obviousness .............................................................................................. 11
`Terminal Disclaimer ............................................................................................. 16
`C.
`PERSON OF ORDINARY SKILL IN THE ART ............................................................ 16
`VI.
`VII. TECHNOLOGY BACKGROUND .................................................................................. 17
`A.
`The Cardiovascular System and the Cardiac Cycle .............................................. 17
`B.
`Tools Used to Measure Heart Parameters and Other Physiological Information . 21
`1.
`Using an ECG to Measure Cardiac Activity ............................................. 22
`2.
`Using a PPG to Measure Cardiac Activity ............................................... 27
`VIII. THE ’499 AND ’731 PATENTS ...................................................................................... 28
`A.
`Overview of the ’499 and ’731 Patents ................................................................. 28
`B.
`State of the Art for the ’499 and ’731 Patents ...................................................... 30
`1.
`AMON ...................................................................................................... 36
`2.
`Kotzin ........................................................................................................ 37
`3.
`Almen ........................................................................................................ 39
`4.
`Tran ........................................................................................................... 41
`5.
`Thomsen .................................................................................................... 43
`6.
`Libbus ....................................................................................................... 44
`Prosecution History of the ’499 and ’731 Patents ................................................ 46
`1.
`Prosecution History of the ’499 Patent ..................................................... 46
`2.
`Prosecution History of the ’731 Patent ..................................................... 49
`Asserted Claims of the ’499 and ’731 Patents ...................................................... 51
`D.
`Claim Constructions for the ’499 and ’731 Patents .............................................. 53
`E.
`THE ’941 PATENT .......................................................................................................... 54
`A.
`Overview of the ’941 Patent ................................................................................. 54
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`IX.
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`C.
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`i
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`2
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`X.
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`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`B.
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`C.
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`D.
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`State of the Art for the ’941 Patent ....................................................................... 56
`1.
`Specific ’941 Patent State-of-the-Art Disclosures .................................... 56
`Prosecution History of the ’941 Patent ................................................................. 62
`C.
`Asserted Claims of the ’941 Patent ....................................................................... 65
`D.
`Claim Constructions for the ’941 Patent ............................................................... 66
`E.
`INVALIDITY OF THE ’499 PATENT ............................................................................ 67
`A.
`Summary of Invalidity Opinions for the ’499 Patent............................................ 67
`B.
`Ineligible Subject Matter of the ’499 Patent ......................................................... 67
`1.
`Independent Claims 1 and 11 .................................................................... 68
`2.
`Dependent Claims 6-7, 9-10, 16-17, and 20 ............................................. 74
`Invalidity in View of AMON, Kotzin, and Almen ............................................... 77
`1.
`Reasons to Combine the References ......................................................... 77
`2.
`Claim 1 ...................................................................................................... 79
`3.
`Claim 6: The method of claim 1, wherein said mobile computing device
`comprises a smartwatch. ........................................................................... 95
`Claim 7: The method of claim 1, further comprising determining a
`presence of said arrhythmia using a machine learning algorithm. ............ 96
`Claim 9: The method of claim 7, wherein said machine learning algorithm
`stores heart rate and heart rate variability data associated with arrhythmias
`in a second user and determines said presence of said arrhythmia in said
`first user based on said stored heart and heart rate variability data
`associated with arrhythmias in said second user. ...................................... 98
`Claim 10: The method of claim 1, wherein an irregularity comprises an
`increase in said heart rate variability of said first user without a
`corresponding increase in said activity level of said first user. .............. 101
`Claim 11 .................................................................................................. 103
`Claim 16: The system of claim 11, wherein said mobile computing device
`comprises a smartwatch. ......................................................................... 109
`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. ................................................................... 109
`Claim 20: The system of claim 11, wherein an irregularity comprises an
`increase in said heart rate variability of said first user without a
`corresponding increase in said activity level of said first user. .............. 109
`Invalidity in View of Tran, Thomsen, and Libbus .............................................. 110
`1.
`Reasons to Combine the References ....................................................... 110
`2.
`Claim 1 .................................................................................................... 111
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`7.
`8.
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`4.
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`5.
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`6.
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`9.
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`10.
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`ii
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`3.
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`4.
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`5.
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`6.
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`9.
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`10.
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`3.
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`4.
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`7.
`8.
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`Claim 6: The method of claim 1, wherein said mobile computing device
`comprises a smartwatch. ......................................................................... 125
`Claim 7: The method of claim 1, further comprising determining a
`presence of said arrhythmia using a machine learning algorithm. .......... 126
`Claim 9: The method of claim 7, wherein said machine learning algorithm
`stores heart rate and heart rate variability data associated with arrhythmias
`in a second user and determines said presence of said arrhythmia in said
`first user based on said stored heart and heart rate variability data
`associated with arrhythmias in said second user. .................................... 127
`Claim 10: The method of claim 1, wherein an irregularity comprises an
`increase in said heart rate variability of said first user without a
`corresponding increase in said activity level of said first user. .............. 129
`Claim 11 .................................................................................................. 130
`Claim 16: The system of claim 11, wherein said mobile computing device
`comprises a smartwatch. ......................................................................... 136
`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. ................................................................... 136
`Claim 20: The system of claim 11, wherein an irregularity comprises an
`increase in said heart rate variability of said first user without a
`corresponding increase in said activity level of said first user. .............. 136
`INVALIDITY OF THE ’731 PATENT .......................................................................... 136
`A.
`Summary of Invalidity Opinions for the ’731 Patent.......................................... 136
`B.
`Ineligible Subject Matter of the ’731 Patent ....................................................... 137
`1.
`Independent Claims 1 and 17 .................................................................. 137
`2.
`Dependent Claims 3, 5, 7-10, 12, 15-16, 19, 21, and 23-24 ................... 143
`Invalidity in View of AMON, Kotzin, and Almen ............................................. 148
`1.
`Claim 1 .................................................................................................... 148
`2.
`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. .......................................................... 164
`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. .................. 165
`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. ............................................. 168
`
`XI.
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`C.
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`iii
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`4
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`5.
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`6.
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`7.
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`8.
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`9.
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`10.
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`11.
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`12.
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`13.
`14.
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`15.
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`16.
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`17.
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`18.
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`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. .................. 173
`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.
`................................................................................................................. 176
`Claim 8: The smart watch of claim 7, wherein the one or more features
`correspond to an HRV signal analyzed in a time domain. ...................... 180
`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. ....................................................................... 181
`Claim 10: The smart watch of claim 7, wherein the one or more features
`are features of an HRV signal analyzed geometrically. .......................... 182
`Claim 12: The smart watch of claim 1, wherein the processing device is
`further configured to generate a notification of the detected arrhythmia.
`................................................................................................................. 184
`Claim 15: The smart watch of claim 1, the processing device further
`configured to display an ECG rhythm strip from the ECG data. ............ 185
`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. ...................................................................... 186
`Claim 17 .................................................................................................. 188
`Claim 18: The method of claim 17, wherein detecting the presence of the
`arrhythmia comprises: receiving motion sensor data from a motion sensor
`of the smartwatch; and determine, from motion sensor data, that the user is
`at rest. ...................................................................................................... 189
`Claim 19: The method of claim 18, wherein detecting the presence of the
`arrhythmia comprises inputting the PPG data into a machine learning
`algorithm trained to detect arrhythmias. ................................................. 189
`Claim 20: The method of claim 18, wherein detecting the presence of the
`arrhythmia comprises: determining heartrate variability (“HRV”) data
`from the PPG data; and detecting, based on the HRV data, the presence of
`the arrhythmia. ........................................................................................ 190
`Claim 21: The method of claim 20, wherein detecting the presence of the
`arrhythmia comprises inputting the HRV data into a machine learning
`algorithm trained to detect arrhythmias. ................................................. 190
`Claim 23: The method of claim 17, further comprising generating a
`notification of the detected arrhythmia. .................................................. 190
`
`iv
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`D.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`19.
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`Claim 24: The method of claim 17, further comprising receiving the ECG
`data from the ECG sensor in response to receiving an indication of a user
`action. ...................................................................................................... 191
`Invalidity in View of Tran, Thomsen, and Libbus .............................................. 191
`1.
`Claim 1 .................................................................................................... 191
`2.
`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. .......................................................... 205
`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. .................. 206
`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. ............................................. 209
`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. .................. 212
`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.
`................................................................................................................. 215
`Claim 8: The smart watch of claim 7, wherein the one or more features
`correspond to an HRV signal analyzed in a time domain. ...................... 218
`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. ....................................................................... 219
`Claim 10: The smart watch of claim 7, wherein the one or more features
`are features of an HRV signal analyzed geometrically. .......................... 221
`Claim 12: The smart watch of claim 1, wherein the processing device is
`further configured to generate a notification of the detected arrhythmia.
`................................................................................................................. 222
`Claim 15: The smart watch of claim 1, the processing device further
`configured to display an ECG rhythm strip from the ECG data. ............ 224
`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. ...................................................................... 225
`Claim 17 .................................................................................................. 226
`
`10.
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`11.
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`12.
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`13.
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`v
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`6
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`15.
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`Claim 18: The method of claim 17, wherein detecting the presence of the
`arrhythmia comprises: receiving motion sensor data from a motion sensor
`of the smartwatch; and determine, from motion sensor data, that the user is
`at rest. ...................................................................................................... 227
`Claim 19: The method of claim 18, wherein detecting the presence of the
`arrhythmia comprises inputting the PPG data into a machine learning
`algorithm trained to detect arrhythmias. ................................................. 228
`Claim 20: The method of claim 18, wherein detecting the presence of the
`arrhythmia comprises: determining heartrate variability (“HRV”) data
`from the PPG data; and detecting, based on the HRV data, the presence of
`the arrhythmia. ........................................................................................ 228
`Claim 21: The method of claim 20, wherein detecting the presence of the
`arrhythmia comprises inputting the HRV data into a machine learning
`algorithm trained to detect arrhythmias. ................................................. 228
`Claim 23: The method of claim 17, further comprising generating a
`notification of the detected arrhythmia. .................................................. 229
`Claim 24: The method of claim 17, further comprising receiving the ECG
`data from the ECG sensor in response to receiving an indication of a user
`action. ...................................................................................................... 229
`INVALIDITY OF THE ’941 PATENT .......................................................................... 229
`A.
`Summary of Invalidity Opinions for the ’941 Patent.......................................... 229
`B.
`Ineligible Subject Matter of the ’941 Patent ....................................................... 230
`1.
`Independent Claims 1 and 12 .................................................................. 230
`2.
`Dependent Claims 2, 5, 10-11, 13, 16, and 19-23 .................................. 235
`Invalidity in View of AMON, Kotzin, and Almen ............................................. 240
`1.
`Claim 1 .................................................................................................... 240
`2.
`Claim 2: The method according to claim 1, wherein the heart rate
`parameter comprises an indication of a heart rate variability, and wherein
`the arrhythmia is atrial fibrillation. ......................................................... 254
`Claim 5: The method according to claim 1, wherein indicating to the user
`further comprises: instructing the user to record an ECG using the
`smartwatch. ............................................................................................. 257
`Claim 10: The method according to claim 1 further comprising: displaying
`an ECG rhythm strip from the electric signals on the smartwatch. ........ 260
`Claim 11: The method according to claim 1, wherein the first electrode is
`located on the smartwatch in a location 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 in a location where the user
`must actively contact the second electrode with a second side of the user's
`body opposite from the first side. ........................................................... 260
`
`16.
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`17.
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`18.
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`19.
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`3.
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`4.
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`5.
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`14.
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`XII.
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`C.
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`vi
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`8.
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`9.
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`10.
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`11.
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`6.
`7.
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`Claim 12 .................................................................................................. 262
`Claim 13: The smartwatch or wristlet according to claim 12, wherein the
`heart rate parameter comprises an indication of a heart rate variability, and
`wherein the arrhythmia is atrial fibrillation. ........................................... 269
`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. .................................................................... 269
`Claim 18: The smartwatch according to claim 12, wherein the heart rate
`parameter is a PPG signal. ...................................................................... 269
`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. ..................................................... 271
`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. ...................................................................................................... 274
`Claim 21: The smartwatch according to claim 12, the processor further to:
`display an ECG rhythm strip from the electric signals. .......................... 276
`Claim 22: The smartwatch according to claim 12, wherein the PPG sensor
`is located on a back of the smartwatch. .................................................. 276
`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. .................................................................... 277
`Invalidity in View of Tran, Thomsen, and Libbus .............................................. 278
`1.
`Claim 1 .................................................................................................... 278
`2.
`Claim 2: The method according to claim 1, wherein the heart rate
`parameter comprises an indication of a heart rate variability, and wherein
`the arrhythmia is atrial fibrillation. ......................................................... 288
`Claim 5: The method according to claim 1, wherein indicating to the user
`further comprises: instructing the user to record an ECG using the
`smartwatch. ............................................................................................. 290
`Claim 10: The method according to claim 1 further comprising: displaying
`an ECG rhythm strip from the electric signals on the smartwatch. ........ 294
`Claim 11: The method according to claim 1, wherein the first electrode is
`located on the smartwatch in a location 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 in a location where the user
`must actively contact the second electrode with a second side of the user's
`body opposite from the first side. ........................................................... 294
`
`D.
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`12.
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`13.
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`14.
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`3.
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`4.
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`5.
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`6.
`7.
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`8.
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`9.
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`Claim 12 .................................................................................................. 296
`Claim 13: The smartwatch or wristlet according to claim 12, wherein the
`heart rate parameter comprises an indication of a heart rate variability, and
`wherein the arrhythmia is atrial fibrillation. ........................................... 306
`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. .................................................................... 306
`Claim 18: The smartwatch according to claim 12, wherein the heart rate
`parameter is a PPG signal. ...................................................................... 307
`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. ..................................................... 309
`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. ...................................................................................................... 311
`Claim 21: The smartwatch according to claim 12, the processor further to:
`display an ECG rhythm strip from the electric signals. .......................... 313
`Claim 22: The smartwatch according to claim 12, wherein the PPG sensor
`is located on a back of the smartwatch. .................................................. 314
`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. .................................................................... 316
`XIII. ALLEGED SECONDARY CONSIDERATIONS ......................................................... 316
`A.
`No Evidence of Copying ..................................................................................... 317
`B.
`No Evidence of Long-Felt but Unmet Need and Failure of Others .................... 320
`C.
`No Evidence of Commercial Success ................................................................. 322
`D.
`Alleged Licenses ................................................................................................. 325
`E.
`No Evidence of Skepticism ................................................................................. 326
`F.
`No Evidence of Industry Praise .......................................................................... 326
`
`10.
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`11.
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`12.
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`13.
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`14.
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`I.
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`INTRODUCTION
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`1.
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`I am an expert, retained on behalf of Apple Inc. (“Apple”). In this report, I set
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`forth my opinions regarding whether the asserted claims of U.S. Patent Nos. 9,572,499 (“’499
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`patent”), 10,595,731 (“’731 patent”), and 10,638,941 (“’941 patent”) are valid. This report
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`contains a statement of my opinions formed in this case and provides the bases and reasons for
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`those opinions. The statements made below are of my own knowledge and, if called to testify
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`about these statements, I could and would do so competently.
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`2.
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`In preparing this report, I have reviewed and considered the ’499 patent, the ’731
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`patent, and the ’941 patent (including the figures, specifications, and claims of each patent), each
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`patent’s prosecution history, various references and other documents listed in the “Materials
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`Considered” and referenced in this report, as well as my general knowledge as a medical doctor,
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`a board-certified practicing cardiologist at Massachusetts General Hospital, a Professor of
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`Medical Engineering and Science at the Massachusetts Institute of Technology (MIT), a
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`Professor of Electrical Engineering and Computer Science at MIT, and a faculty member in the
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`Harvard-MIT Division of Health Sciences and Technology.
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`3.
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`I first list my qualifications to demonstrate that I am a person of skill in the art. I
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`also list the materials that I considered. I then provide an overview of the relevant legal
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`principles, as explained to me by Apple’s counsel, and the relevant level of ordinary skill in the
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`art. I subsequently provide a general background on the cardiovascular system, cardiac
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`arrhythmias, sensors used to take certain physiological measurements, how medical doctors,
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`including cardiologists have used, and might today use, those measurements to identify certain
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`cardiac arrhythmias, as well as provide an overview of the asserted patents. Finally, I provide
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`my opinions on whether the asserted claims of the ’499, ’731, and ’941 patents are valid.
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`4.
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`This report is based on information currently available to me, and I am willing to
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`testify on the topics addressed below. This Investigation is ongoing, and I may supplement or
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`amend these opinions based on the results of further analysis and in rebuttal to positions taken by
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`Complainant AliveCor and/or by Staff. Because this report is based on information currently
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`available to me, I reserve the right to continue my investigation, to review documents and
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`information that may be produced, and to consider reports, declarations, briefing, and deposition
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`testimony from future depositions in this case. Therefore, I reserve the right to supplement,
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`expand, and/or modify my opinions as my investigation continues and in response to any
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`additional information that comes to my attention, including matters raised by Complainants,
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`including opinions provided by Complainants’ expert(s), and/or position taken by Staff.
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`5.
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`I am being compensated at a rate of $900/hour for my work in this matter. This
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`compensation is in no way based on the outcome of this litigation or on the opinions that I
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`provide. I have no interest, financial or otherwise, in the outcome of the litigation between
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`Apple and AliveCor. I have not provided any testimony as an expert at deposition or trial in the
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`past four years.
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`6.
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`If called upon to testify or be deposed in this investigation, I may cite the content
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`of this report and the materials cited herein, as well as the additional documents considered, and
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`any statements or references by AliveCor’s witnesses and experts. I also reserve the right to
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`create demonstrative exhibits, or provide demonstrations in support of any testimony I may
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`provide relating to the content of this report, the attached claim charts, and any additional
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`documents and prior art systems described therein.
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`II.
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`QUALIFICATIONS
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`7.
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`My current CV is attached as Exhibit A. It includes a summary of my educational
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`background, publications at least within the last 10 years, employment and career history, and
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`CONFIDENTIAL BUSINESS