In the Matter of Certain Wearable Electronic Devices
`with ECG Functionality and Components Thereof
`Investigation No. 337-TA-1266
`
`Collin Stultz, M.D., Ph.D
`
`March 31, 2022
`
`RDX-0003.1
`
`APPLE 1083
`Apple v. AliveCor
`IPR2021-00970
`
`1
`
`

`

`Education
`
`Dr. Collin Stultz
`M.D., Ph.D
`
`• Harvard College
`(cid:2236) Bachelor’s degree in Mathematics and Philosophy
`(cid:2236) magna cum laude
`• Harvard Medical School
`(cid:2236) Doctor of Medicine (Harvard-MIT Division of
`Health Sciences and Technology)
`(cid:2236) magna cum laude
`• Harvard University
`(cid:2236) Ph.D. in Biophysics
`• Brigham & Women’s Hospital
`(cid:2236) Intern and Resident, Department of Medicine
`• Brigham & Women’s Hospital
`(cid:2236) Cardiology Fellow, Division of Cardiology
`
`RX-309
`RDX-0003.2
`
`2
`
`

`

`Practicing Cardiologist / Professor of Engineering MIT, Harvard
`• Nearly 20 years as a board-certified cardiologist
`(cid:2236) Veteran’s Affairs Hospital
`• 2003-2017 (~ 15 years)
`(cid:2236) Massachusetts General Hospital
`• 2017-present (~ 5 years)
`• Nearly 20 years teaching undergraduate and
`graduate students
`• Nina T. and Robert H. Rubin endowed Professor of
`Medical Engineering and Science and a Professor of
`Electrical Engineering and Computer Science
`• Faculty member in Harvard-MIT Division of Health
`Sciences and Technology
`• Previous work as Adjunct Associate Professor of
`Medicine, Boston University Medical School
`
`Dr. Collin Stultz
`M.D., Ph.D
`
`RX-309
`RDX-0003.3
`
`3
`
`

`

`Teach Students How to Acquire ECG Data, Interpret Data
`
`RDX-0003.4
`
`4
`
`

`

`Teach Students How to Calculate HRV from PPG Signals
`
`RDX-0003.5
`
`5
`
`

`

`Experience Designing Wearables with Physiological Sensors
`and Employing Machine Learning for Analysis of Signals
`• Bloomertech
`(cid:2236) Developing wearable ECG (among other sensors)
`in women’s bra to identify abnormalities, including
`heart disease
`• Empallo
`(cid:2236) Developing machine learning algorithms for
`analyzing patient data for personal healthcare
`plans
`• Unlearn AI
`(cid:2236) Product combines AI, Digital Twins, and novel
`statistical methods to enable smaller, more
`efficient clinical trials
`
`Dr. Collin Stultz
`M.D., Ph.D
`
`RX-309
`RDX-0003.6
`
`6
`
`

`

`Awards and Recognition
`
`Dr. Collin Stultz
`M.D., Ph.D
`
`• AIMBE Fellow – represents the top 2% of
`biomedical engineers in the country.
`• Burroughs Wellcome Fund Career Award in
`Biomedical Sciences – career award for
`physician scientists who are committed to an
`academic career.
`Irving M. London Teaching Award at MIT –
`awarded (by students) to faculty who have
`made outstanding contributions to the
`training of HST students.
`• Fellow of the American College of Cardiology
`• National Science Foundation CAREER Award
`
`•
`
`RX-309
`RDX-0003.7
`
`7
`
`

`

`POSITA Under Both Prongs of the Court’s Definition
`
`Order No 12: Construing the Terms of the Asserted Claims of the Patents at Issue, at 10
`RDX-0003.8
`
`8
`
`

`

`Summary of Opinions
`
`• Dr. Jafari conflates or otherwise misstates certain fundamental cardiology
`concepts in his opinions.
`• The asserted claims of the ’499, ’731, and ’941 patents are directed to patent
`ineligible subject matter.
`• The asserted claims of the ’499 and ’731 patents are invalid in light of the AMON
`Reference combined with the prior art and knowledge of a POSITA in 2013.
`• The asserted claims of the ’941 patent are invalid in light of the AMON Reference
`combined with the prior art and knowledge of a POSITA in 2015.
`
`RDX-0003.9
`
`9
`
`

`

`Normal Heart Function
`
`Body
`
`Lungs
`
`Right
`Atrium
`
`Left
`Atrium
`
`Right
`Ventricle
`
`Left
`Ventricle
`
`Lungs
`
`Body
`
`RDX-0003.10
`
`10
`
`

`

`Normal Heart Function
`
`RDX-0003.11
`
`11
`
`

`

`Normal Depolarization of the Heart
`
`Atrial
`Depolarization
`
`L Ventricular
`Depolarization
`
`Ventricles
`Depolarization
`
`Ventricles
`Depolarization
`
`RDX-0003.12
`
`12
`
`

`

`Abnormal Electrical Conduction of the Heart
`Normal Sinus Rhythm
`
`Sinus Tachycardia
`
`Atrial Flutter with Variable Block
`
`Atrial Fibrillation
`
`Fast
`
`Irregular
`
`Irregular
`
`RDX-0003.13
`
`13
`
`

`

`Court’s Definition of Arrhythmia
`
`Order No 12: Construing the Terms of the Asserted Claims of the Patents at Issue, p. 12
`RDX-0003.14
`
`14
`
`

`

`Abnormalities in Conduction Due to Cardiac Conditions
`
`Atrial Fibrillation
`
`Myocardial Infarction
`
`Bursts of Ventricular Tachycardia
`
`RDX-0003.15
`
`15
`
`

`

`Abnormalities in Conduction Not Due to Cardiac Conditions
`
`Exercise
`
`Infection
`
`Medications
`
`Sinus Tachycardia
`
`Sinus Tachycardia
`
`Ventricular Premature Beats
`
`RDX-0003.16
`
`16
`
`

`

`Tachycardia
`
`Overview
`
`Tachycardia (tak-ih-KAHR-dee-uh)is the medical term for a heart rate over 100 beats a minute.
`Manytypesofirregular heart rhythms(arrhythmias) can cause tachycardia.
`
`A fast heart rate isn't always a concern. For instance, the heart rate typically rises during exercise
`or as a responseto stress.
`
`MAYO
`CLINIC
`
`
`
`
`
`ine eu
`MAYO
`CLINIC
`
`gy
`
`
`
`
`
`Smoking
`
`Tachycardia
`Overview
`Tachycardia(tak-ih-KAMR-dee-uh)is the medical term for a heart rate over 100beats a minute,
`Manytypes of iregular heartrhythms (arrhythmias) can causetachycardia.
`A fast heartrate istalways a concem,Forinstance, theheart rate typically rises duringexercise
`Ofa8a response tostress.
`‘Tachycardiamay not cause any symptoms or complications. Gutif left untreated, some forms of
`tachycardia can lead to serious health problems, includingheart failure, strokeor sudden cardiac
`death,
`Treatmentfor tachycardia may includespecific maneuvers, medication, cardioversion ofsurgery to
`contro!a rapid heartbeat.
`Types
`‘There aremany differenttypes oftachycardia. Sinus tachycardia referstoa typical increaseinthe
`haart rate ofancausedby exerciseor stress.
`‘Othertypes oftachycardia aregrouped accordingta the part of the heart responsible forthe fast
`heart rate and the cause, Common types of tachycardia caused byregular heartrhythms,
`Heavy alcoholuse oralcohol withdrawal
`(arrhythmias)include
`+ Atrial fibrillation (A-fib). This isthe most common typeoftachycardia. Chaotic,imegular
`High levels of caffeine
`‘electrical signals in the upperchambers of the heart (atria) cause a fast heartbeat, A:fy may be
`temporary, butsomeepisodes won't end uniess treated
`© Atrial flutter. Atrial flutter issimilar toAci, but heartbeats are more organized, Episodesof
`High or low blood pressure
`Lalralfluttermay go away themselvesor mayraquitetreatment, Peoplewhohaws atrial flutter
`alsooften have atrial ibsiliation at other tenes.
`Imbalance of substances in the blood called electrolytes — such as potassium, sodium,
`+ Ventriculartachycardia. Thistypeofarrhythmia stants in the lower heart chambers
`(ventricles), The rapid heartrate doesn'tallowthe ventricles tofill and squeeze (contract) to
`calcium and magnesium
`pumpenough blood to the body. Ventricular tachycardia episodes may be briefand lastonlya
`coupleofseconds without causing harm. Butepisodes lasting more than a few secondscan be
`Medication side effects
`life-threataning
`us
`cerinemayscinerpibseatisaronbtacnycadasetotomcannehayeSOIEEAETet
`Overactive thyroid (hyperthyroidism)
`APLAALIVE_0oasz07e:
`Axo7esO01
`Reduced volumeof red blood cells (anemia), often caused by bleeding
`
`Tachycardia can also be caused byan irregular heart rhythm (arrhythmia).
`
`Things that may lead to tachycardia include:
`Fever
`
`RX-764, at 1, 3
`RX-764, at 1, 3
`RDX-0003.17
`RDX-0003.17
`
`17
`
`17
`
`

`

`12-Lead ECG vs. 1 Lead ECG
`12-Lead ECG
`
`1-Lead ECG
`
`International Journal of Cardiology, v152 p184-191, 2011
`
`CX-0051C
`
`RDX-0003.18
`
`18
`
`

`

`The ECG Can Be Used to Diagnose Many Cardiac Conditions
`Normal Sinus Rhythm
`Atrial Fibrillation
`
`Myocardial Infarction
`
`Left Atrial Enlargement
`
`Left Ventricular Enlargement
`
`RDX-0003.19
`
`19
`
`

`

`Standard for Patent Eligible Subject Matter
`
`• Step 1: Determine whether the claims at issue are directed to an abstract idea
`• Step 2: If abstract idea, consider the elements of the claim both individually
`and as an ordered combination to determine whether the claim
`elements add an “inventive concept” to the otherwise abstract idea
`• Further Considerations:
`(cid:2236) Cannot recite well-understood, routine, and conventional activities known in the art
`(cid:2236) Cannot implement with conventional components or generic computer hardware or software
`(cid:2236) Cannot recite generic functional language to achieve the claimed result without more
`
`RDX-0003.20
`
`20
`
`

`

`Steps in a Routine Clinical Cardiac Exam
`
`1. Patient comes into office
`
`2. Measure pulse (e.g., PPG, manually)
`
`3. Assess regular rate and rhythm
`(any qualitative variations in the heart rate at rest)
`
`4. If irregularity is suspected, order ECG
`
`5. Analyze ECG data for diagnosis
`
`RDX-0003.21
`
`21
`
`

`

`US Patent No. 9,572,499
`US Patent No. 9,572,499
`
`OS72D
`US 9,572,499 B2
`
`*Feb, 21,2017
`
`* le 7
`a
`
`az United States Patent
`Gopalakrishnanetal.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 9,572,499 B2
`*Feb. 21, 2017
`
`(22) Filed:
`
`Jun. 3, 2015
`
`(60) Provisional application No. 61/915,113,filed onDec.
`provisional application No. 61/953,616,
`filed on Mar. 14, 2014, provisional application No.
`61/969,019,
`filed on Mar. 21, 2014, provisional
`application No. 61/970,551, filed on Mar. 26, 2014,
`provisional application No. 62/014,516, filed on Jun.
`19, 2014.
`
`JX-001 (’499 Patent)
`JX-001 (‘499 Patent)
`RDX-0003.22
`RDX-0003.22
`
`22
`
`22
`
`

`

`Unpatentable Subject Matter: ’499 Patent Instructions
`(claim 11 (Not Asserted))
`
`1) Receiving heart rate data
`2) Sensing an activity level
`3) Determining HRV
`4) Comparing HRV to activity level
`5) Alerting user to record ECG
`
`JX-001 (’499 Patent), Claim 11
`RDX-0003.23
`
`23
`
`

`

`Unpatentable Subject Matter: ’499 Patent Hardware
`Components (claim 11 (Not Asserted))
`
`• Heart rate sensor
`• Mobile computing device
`with processor (configured
`to sense ECG)
`• Motion sensor
`• Non-transitory computer
`readable medium
`
`JX-001 (’499 Patent), Claim 11
`RDX-0003.24
`
`24
`
`

`

`Unpatentable Subject Matter: ’499 Patent Dependent Claims
`
`JX-001 (’499 Patent), Claims 16, 17
`RDX-0003.25
`
`25
`
`

`

`US Patent 10,595,731
`US Patent 10,595,731
`
` ux United States Patent
`
`a2) United States Patent
`Gopalakrishnan etal.
`
`do) Patent No:
`(45) Date of Patent:
`
`US 10,595,731 B2
`Mar. 24, 2020
`
`(22)
`
`Filed:
`
`Sep. 30, 2019
`
`(60) Provisional application No. 62/014,516, filed on Jun.
`19, 2014, provisional application No. 61/970,551,
`filed on Mar. 26, 2014, provisional application No.
`61/969,019,
`filed on Mar. 21, 2014, provisional
`application No. 61/953,616, filed on Mar. 14, 2014,
`
`aa application No. 61/915,115,filed onDee.
`
`JX-002 (‘731 Patent)
`JX-002 (‘731 Patent)
`RDX-0003.26
`RDX-0003.26
`
`26
`
`26
`
`

`

`Unpatentable Subject Matter:
`’731 Patent Instructions (claim 1)
`
`1) Receiving PPG data
`2) Detecting an arrhythmia
`based on PPG data
`3) Receiving ECG data
`4) Confirming the presence of
`the arrhythmia with ECG
`
`JX-002 (‘731 Patent) Claim 1
`RDX-0003.27
`
`27
`
`

`

`Unpatentable Subject Matter:
`’731 Patent Hardware Components (claim 1)
`
`• Smartwatch
`• Processing device
`• PPG sensor
`• ECG sensor
`• Display
`• Memory
`
`JX-002 (‘731 Patent) Claim 1
`RDX-0003.28
`
`28
`
`

`

`Unpatentable Subject Matter: ’731 Patent Dependent Claims
`
`Claim 2 (Not Asserted)
`
`Claim 4 (Not Asserted)
`
`Claim 3
`
`Claim 5
`
`JX-002 (‘731 Patent) Claims, 2-5
`RDX-0003.29
`
`29
`
`

`

`Unpatentable Subject Matter: ’731 Patent Dependent Claims
`
`Claim 7 (Not Asserted)
`
`Claim 9
`
`Claim 8
`
`Claim 10
`
`JX-002 (‘731 Patent) Claims, 7-10
`RDX-0003.30
`
`30
`
`

`

`Unpatentable Subject Matter: ’731 Patent Dependent Claims
`
`Claim 16
`
`Claim 12
`
`Claim 15
`
`JX-002 (‘731 Patent) Claims, 12, 15-16
`RDX-0003.31
`
`31
`
`

`

`US Patent 10,638,941
`US Patent 10,638,941
`
`un United States Patent
`
`0) Patent No:
`
`US 10,638,941 BZ
`
`soto
`
`oS
`
`“
`
`a2) United States Patent
`Albertet al.
`
` (22) Filed:
`
`
`(10) Patent No:
`(45) Date of Patent:
`
`US 10,638,941 B2
`*May 5, 2020
`
`Oct. 11, 2018
`
`(60) Provisional application No. 62/161,092,filed onMay
`
`JX-003 (’941 Patent)
`JX-003 (‘941 Patent)
`RDX-0003.32
`RDX-0003.32
`
`32
`
`32
`
`

`

`Unpatentable Subject Matter: ’941 Patent Instructions (claim 12)
`
`1) Determining when an activity level is
`“resting”
`2) Sensing a heart rate parameter
`3) Determining a discordance between the
`heart rate parameter and activity level
`4) Indicating an arrhythmia based on the
`discordance
`5) Confirming the arrhythmia with ECG data
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.33
`
`33
`
`

`

`Unpatentable Subject Matter: ’941 Patent Instructions (claim 12)
`
`1) Determining when an activity level is
`“resting”
`2) Sensing a heart rate parameter
`3) Determining a discordance between the
`heart rate parameter and activity level
`4) Indicating an arrhythmia based on the
`discordance
`5) Confirming the arrhythmia with ECG data
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.34
`
`34
`
`

`

`Unpatentable Subject Matter: ’941 Patent Hardware (claim 12)
`
`• Smartwatch
`• Processor
`• Activity level sensor
`• PPG sensor
`• ECG sensor
`• Non-transitory computer
`readable storage medium
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.35
`
`35
`
`

`

`Unpatentable Subject Matter: ’941 Patent Hardware (claim 12)
`
`• Smartwatch
`• Processor
`• Activity level sensor
`• PPG sensor
`• ECG sensor
`• Non-transitory computer
`readable storage medium
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.36
`
`36
`
`

`

`Unpatentable Subject Matter: ’941 Patent
`
`Claim 13
`
`Claim 18 (Not Asserted)
`
`Claim 16
`
`Claim 19
`
`JX-003 (‘941 Patent) Claims 13, 16, 18, 19
`RDX-0003.37
`
`37
`
`

`

`Unpatentable Subject Matter: ’941 Patent Dependent Claims
`
`Claim 20
`
`Claim 21
`
`Claim 22
`
`Claim 23
`
`JX-003 (‘941 Patent) Claims 20-23
`RDX-0003.38
`
`38
`
`

`

`Obviousness Standard
`As viewed by a person of ordinary skill in the art at the time of the
`alleged invention:
`1) Scope and content of prior art
`2) The differences between the prior art and the challenged patent claim
`3) The level of ordinary skill in the art
`4) Any secondary considerations of non-obviousness
`(as set forth by AliveCor)
`Must be shown by clear and convincing evidence
`
`RDX-0003.39
`
`39
`
`

`

`State of the Art
`
`July 14, 2007
`Mohammadzadeh Asl
`(RX-562)
`
`2006
`Leijdekkers
`(RX-560)
`
`2010
`Thalange & Mergu
`(RX-563)
`
`May 13, 2015
`‘941 Patent Priority Date
`
`September 2, 2009
`Suzuki
`(RX-554)
`
`December 12, 2013
`‘499 Patent Priority Date
`
`December 12, 2013
`‘731 Patent Priority Date
`
`2006
`
`2007
`
`2009
`
`2010
`
`2013
`
`2015
`RDX-0003.40
`
`40
`
`

`

`December 2004
`AMON Reference published
`
`December 12, 2013
`‘499 Patent Priority Date
`
`May 13, 2015
`‘941 Patent
`Priority Date
`
`RX-0419
`
`December 12, 2013
`‘731 Patent Priority Date
`
`2004
`
`2008
`
`2009
`
`2013
`
`2015
`
`February 5, 2004
`Kotzin published
`
`December 2, 2008
`Almen published
`
`RDX-0003.41
`
`41
`
`

`

`The AMON Reference
`
`RX-0419, Fig. 1
`
`RX-0419 (AMON Reference), at 1
`
`RX-0419 (AMON Reference), at 1
`RDX-0003.42
`
`42
`
`

`

`Others Cited and Were Inspired by
`the AMON Reference’s Disclosure
`Leijdekkers, 2006:
`
`Pantelopoulos, 2006:
`
`RX-560 (Leijdekkers), at 1
`
`RX-420 (Pantelopoulos), at 5
`RDX-0003.43
`
`43
`
`

`

`Almen
`Almen
`
`on United States Patent
`CM) APRURATUS AND MIC THOD FOR
`PAT ok:HE AEE BEA
`
`109
`
`se
`
`f is LY) rovided.
`
`RX-0400 (Almen) 2:11-14, 7:26-28, 1:20-24; Fig. 1
`RX-0400 (Almen) 2:11-14, 7:26-28, 1:20-24; Fig.
`1
`RDX-0003.44
`RDX-0003.44
`
`44
`
`44
`
`

`

`Kotzin
`
`Kotzin
`
`Type of Events:
`
`Re-sensing the characteristic
`
`Sensing a different characteristic
`
`Alert the wearer of the portable device
`about the characteristic
`
`RX-0401 (Kotzin), at 18:21-22, 18:22-24, 18:17-18
`RDX-0003.45
`
`45
`
`

`

`US Patent 10,638,941 – Claim 12
`’941 Patent, Claim 12
`
`[Pre] A smartwatch, comprising:
`[A] a processor;
`[B] a first sensor configured to sense an activity level value of a user, wherein the first sensor is coupled to the
`processor;
`
`Invalid?
`
`AliveCor Not Contesting
`
`AliveCor Not Contesting
`
`[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;
`
`AliveCor Not Contesting
`
`[D]
`
`[E]
`
`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.
`
`AliveCor Not Contesting
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.46
`
`46
`
`

`

`[Pre] A smartwatch, comprising:
`
`’941 Patent, Claim 12
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 7
`
`RX-0419 (AMON Reference), Fig. 1
`
`RX-0419 (AMON Reference), at 1
`
`RDX-0003.47
`
`47
`
`

`

`US Patent 10,638,941 – Claim 12
`’941 Patent, Claim 12
`
`[Pre] A smartwatch, comprising:
`[A] a processor;
`[B] a first sensor configured to sense an activity level value of a user, wherein the first sensor is coupled to the
`processor;
`
`Invalid?
`
`AliveCor Not Contesting
`
`AliveCor Not Contesting
`
`[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;
`
`AliveCor Not Contesting
`
`[D]
`
`[E]
`
`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.
`
`AliveCor Not Contesting
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.48
`
`48
`
`

`

`’941 Patent, Claim 12
`a non-transitory computer readable storage medium encoded with a computer program including instructions
`executable by the processor to cause the processor to:
`
`[E]
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 6
`
`RX-0419 (AMON Reference), Fig. 7
`
`RDX-0003.49
`
`49
`
`

`

`[E]
`
`’941 Patent, Claim 12
`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;
`The AMON Reference
`
`RX-0419 (AMON Reference), at 2
`
`RX-0419 (AMON Reference), Table 1
`
`RX-0419 (AMON Reference), at 5
`
`RX-0419 (AMON Reference), Table 6
`
`RDX-0003.50
`
`50
`
`

`

`’941 Patent, Claim 12
`a non-transitory computer readable storage medium encoded with a computer program including instructions executable by
`the processor to cause the processor to: . . . based on the presence of the discordance, indicate to the user a
`possibility of an arrhythmia being present; and
`The AMON Reference
`
`RX-0419 (AMON Reference), at Table 1
`
`Order 12, at 12
`
`RX-0419 (AMON Reference), at 3
`
`RDX-0003.51
`
`51
`
`

`

`’941 Patent, Claim 12
`a non-transitory computer readable storage medium encoded with a computer program including instructions
`executable by the processor to cause the processor to: . . . receive electric signals of the user from the ECG sensor
`to confirm the presence of the arrhythmia.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 6
`
`RX-0419 (AMON Reference), at 3
`
`RX-0419 (AMON Reference), at 3
`
`RDX-0003.52
`
`52
`
`

`

`’941 Patent, Claim 12
`a non-transitory computer readable storage medium encoded with a computer program including instructions
`executable by the processor to cause the processor to: … receive electric signals of the user from the ECG sensor to
`confirm the presence of the arrhythmia.
`Kotzin
`
`RX-0401 (Kotzin), at 18:10-24
`
`RDX-0003.53
`
`53
`
`

`

`US Patent 10,638,941 – Claim 12
`’941 Patent, Claim 12
`
`[Pre] A smartwatch, comprising:
`[A] a processor;
`[B] a first sensor configured to sense an activity level value of a user, wherein the first sensor is coupled to the
`processor;
`
`Invalid?
`
`AliveCor Not Contesting
`
`AliveCor Not Contesting
`
`[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;
`
`AliveCor Not Contesting
`
`[D]
`
`[E]
`
`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.
`
`AliveCor Not Contesting
`
`JX-003 (‘941 Patent), Claim 12
`RDX-0003.54
`
`54
`
`

`

`US Patent 10,638,941 – Claims 13, 16, 19, 20
`
`’941 Patent, 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.
`’941 Patent, 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.
`’941 Patent, Claim 18 (not asserted)
`The smartwatch according to claim 12, wherein the heart rate parameter is a PPG signal.
`’941 Patent, 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.
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`AliveCor Not
`Contesting
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 13, 16, 18, 19, 20
`RDX-0003.55
`
`55
`
`

`

`’941 Patent, 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.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 3
`
`RX-0419 (AMON Reference), at 4
`
`RX-0419 (AMON Reference), at 4
`
`RX-0419 (AMON Reference), at 9
`
`RDX-0003.56
`
`56
`
`

`

`Dr. Jafari’s Explanation of HRV
`
`CDX-0003C.27
`RDX-0003.57
`
`57
`
`

`

`’941 Patent, 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.
`’941 Patent
`
`The AMON Reference
`
`JX-003 (‘941 patent), 4:55-58
`
`RX-0419 (AMON Reference), Table 1
`
`RDX-0003.58
`
`58
`
`

`

`’941 Patent, 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.
`Almen
`
`RX-0400 (Almen), at Abstract
`
`RX-0400 (Almen), at 10:28-35
`
`RX-0400 (Almen), at 1:18-24
`
`RX-0400 (Almen), at 7:26-33
`RDX-0003.59
`
`59
`
`

`

`US Patent 10,638,941 – Claims 13, 16, 19, 20
`
`’941 Patent, 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.
`’941 Patent, 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.
`’941 Patent, Claim 18
`The smartwatch according to claim 12, wherein the heart rate parameter is a PPG signal.
`’941 Patent, 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.
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`AliveCor Not
`Contesting
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 13, 16, 18, 19, 20
`RDX-0003.60
`
`60
`
`

`

`’941 Patent, 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.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 3
`
`RX-0419 (AMON Reference), at 3
`
`RX-0419 (AMON Reference), at 4
`RDX-0003.61
`
`61
`
`

`

`US Patent 10,638,941 – Claims 13, 16, 19, 20
`
`’941 Patent, 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.
`’941 Patent, 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.
`’941 Patent, Claim 18 (Not Contested)
`The smartwatch according to claim 12, wherein the heart rate parameter is a PPG signal.
`’941 Patent, 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.
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`AliveCor Not
`Contesting
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 13, 16, 18, 19, 20
`RDX-0003.62
`
`62
`
`

`

`’941 Patent, 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.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 3
`
`RX-0419 (AMON Reference), at 4
`
`RX-0419 (AMON Reference), at 4
`
`RX-0419 (AMON Reference), at 9
`
`RDX-0003.63
`
`63
`
`

`

`’941 Patent, 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.
`Almen
`
`RX-0400 (Almen) at 1:21-24
`
`RX-0400 (Almen) at 10:28-41
`
`RDX-0003.64
`
`64
`
`

`

`US Patent 10,638,941 – Claims 13, 16, 19, 20
`
`’941 Patent, 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.
`’941 Patent, 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.
`’941 Patent, Claim 18 (Not Contested)
`The smartwatch according to claim 12, wherein the heart rate parameter is a PPG signal.
`’941 Patent, 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.
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`AliveCor Not
`Contesting
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 13, 16, 18, 19, 20
`RDX-0003.65
`
`65
`
`

`

`’941 Patent, 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.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at 9
`
`RX-0419 (AMON Reference), Fig. 7
`
`RX-0419 (AMON Reference), Table IV
`
`RX-0419 (AMON Reference), at 3-4
`
`RDX-0003.66
`
`66
`
`

`

`US Patent 10,638,941 – Claims 13, 16, 19, 20
`
`’941 Patent, 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.
`’941 Patent, 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.
`’941 Patent, Claim 18 (Not Contested)
`The smartwatch according to claim 12, wherein the heart rate parameter is a PPG signal.
`’941 Patent, 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.
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`AliveCor Not
`Contesting
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 13, 16, 18, 19, 20
`RDX-0003.67
`
`67
`
`

`

`US Patent 10,638,941 – Claims 21, 22, 23
`
`’941 Patent, Claim 21
`The smartwatch according to claim 12, the processor further to: display an ECG rhythm strip from the
`electric signals.
`
`’941 Patent, Claim 22
`The smartwatch according to claim 12, wherein the PPG sensor is located on a back of the smartwatch.
`
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 21-23
`RDX-0003.68
`
`68
`
`

`

`’941 Patent, Claim 21
`The smartwatch according to claim 12, the processor further to: display an ECG rhythm strip from the electric signals.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at Fig. 4
`
`RX-0419 (AMON Reference), at 6
`
`RDX-0003.69
`
`69
`
`

`

`US Patent 10,638,941 – Claims 21, 22, 23
`
`’941 Patent, Claim 21
`The smartwatch according to claim 12, the processor further to: display an ECG rhythm strip from the electric
`signals.
`
`’941 Patent, Claim 22
`The smartwatch according to claim 12, wherein the PPG sensor is located on a back of the
`smartwatch.
`
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 21-23
`RDX-0003.70
`
`70
`
`

`

`’941 Patent, Claim 22
`The smartwatch according to claim 12, wherein the PPG sensor is located on a back of the smartwatch.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at Fig. 3
`
`RX-0419 (AMON Reference), at 3-4
`RDX-0003.71
`
`71
`
`

`

`US Patent 10,638,941 – Claims 21, 22, 23
`
`’941 Patent, Claim 21
`The smartwatch according to claim 12, the processor further to: display an ECG rhythm strip from the electric
`signals.
`
`’941 Patent, Claim 22
`The smartwatch according to claim 12, wherein the PPG sensor is located on a back of the smartwatch.
`
`’941 Patent, 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.
`
`Invalid?
`
`Invalid?
`
`Invalid?
`
`JX-003 (‘941 Patent), Claims 21-23
`RDX-0003.72
`
`72
`
`

`

`’941 Patent, 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.
`
`The AMON Reference
`
`RX-0419 (AMON Reference), at Fig. 3
`
`RX-0419 (AMON Reference), at 4
`
`RDX-0003.73
`
`73
`
`

`

`US Patent 10,638,941 – Claims 21, 22, 23
`
`’941 Patent, Claim 21
`The smartwatch according to claim 12