IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Albert et al.
`In re Patent of:
`10,638,941 Attorney Docket No.: 50095-0034IP1
`U.S. Patent No.:
`May 5, 2020
`
`Issue Date:
`Appl. Serial No.: 16/158,112
`
`Filing Date:
`October 11, 2018
`
`Title:
`DISCORDANCE MONITORING
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`PETITION FOR INTER PARTES REVIEW OF UNITED STATES PATENT
`NO. 10,638,941 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`

`

`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`REQUIREMENTS .......................................................................................... 1 
`A.  Grounds for Standing ................................................................................ 1 
`B.  Challenge and Relief Requested ............................................................... 1 
`TECHNOLOGY OVERVIEW AND THE ’941 PATENT ............................ 2 
`A.  Arrhythmia ................................................................................................ 2 
`B.  Electrocardiography (ECG) ...................................................................... 3 
`C.  Photoplethysmography (PPG) .................................................................. 4 
`D.  Heart Rate (HR) ........................................................................................ 5 
`E.  Heart Rate Variability (HRV) ................................................................... 5 
`F.  ’941 Patent ................................................................................................ 6 
`G.  Prosecution History ................................................................................... 8 
`H.  Claim Construction ................................................................................... 8 
`1. 
`“Discordance” (Claims 1, 12) ......................................................... 8 
`III.  THE CHALLENGED CLAIMS ARE UNPATENTABLE .......................... 11 
`A.  [GROUND 1] – Shmueli and Osorio Make Claims 1, 5, 7-9, 11, 12, 16,
`18-20, 22, And 23 Obvious ..................................................................... 11 
`1. 
`Shmueli .......................................................................................... 11 
`2.  Osorio ............................................................................................ 15 
`3. 
`The Shmueli-Osorio Combination ................................................ 20 
`4. 
`Claim 1 .......................................................................................... 31 
`5. 
`Claims 5, 7-9, and 11 .................................................................... 54 
`6. 
`Claim 12 ........................................................................................ 60 
`7. 
`Claims 16, 18-20, and 23 .............................................................. 63 
`8. 
`Claim 22 ........................................................................................ 64 
`B.  [GROUND 2] – Shmueli, Osorio, and Lee-2013 Make Claims 2-4, 6,
`13-15, and 17 Obvious ............................................................................ 65 
`1. 
`Lee-2013 ........................................................................................ 65 
`2. 
`The Shmueli-Osorio-Lee-2013 Combination ............................... 66 
`3. 
`Claims 2-4 and 6 ............................................................................ 68 
`4. 
`Claims 13-15 and 17 ..................................................................... 71 
`C.  [GROUND 3] – Shmueli, Osorio, and Chan Makes Claims 10 and 21
`Obvious ................................................................................................... 72 
`1. 
`Chan ............................................................................................... 72 
`2. 
`The Shmueli-Osorio-Chan Combination ...................................... 74 
`3. 
`Claims 10 and 21 ........................................................................... 76 
`
`i
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`

`

`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`IV.  PTAB DISCRETION SHOULD NOT PRECLUDE INSTITUTION .......... 77 
`V. 
`FEES .............................................................................................................. 83 
`VI.  CONCLUSION .............................................................................................. 83 
`VII.  MANDATORY NOTICES UNDER 37 C.F.R § 42.8(a)(1) ......................... 84 
`A.  Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) .............................. 84 
`B.  Related Matters Under 37 C.F.R. § 42.8(b)(2) ....................................... 84 
`C.  Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ................... 84 
`D.  Service Information ................................................................................ 84 
`
`
`
`
`
`
`ii
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`

`

`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`EXHIBITS
`
`APPLE-1001
`
`U.S. Patent 10,638,941 to Albert et al. (“the ’941 patent”)
`
`APPLE-1002
`
`Excerpts from the Prosecution History of the ’941 patent (“the
`Prosecution History”)
`
`APPLE-1003
`
`Declaration of Dr. Bernard A. Chaitman
`
`APPLE-1004
`
` PCT Patent Publication WO2012/140559 (“Shmueli”)
`
`APPLE-1005
`
` U.S. Patent Publication 2014/0275840 (“Osorio”)
`
`APPLE-1006
`
` Li Q, Clifford GD, “Signal quality and data fusion for false
`alarm reduction in the intensive care unit,” J Electrocardiol.
`2012 Nov-Dec; 45(6):596-603 (“Li-2012”)
`
`APPLE-1007
`
` U.S. Patent Publication 2008/0004904 (“Tran”)
`
`APPLE-1008
`
` U.S. Patent Publication 2014/0107493 (“Yuen”)
`
`APPLE-1009
`
` U.S. Patent Publication 2015/0119725 (“Martin”)
`
`APPLE-1010
`
` U.S. Provisional Application No. 61/794,540 (“Osorio
`Provisional”)
`
`APPLE-1011
`
` Lee J, Reyes BA, McManus DD, Mathias O, Chon KH.
`International Journal of Bioelectromagnetism, Vol. 15, No. 1,
`pp. 26-29, 2013 (“Lee-2013”)
`
`APPLE-1012
`
` Tsipouras MG, Fotiadis DI. Automatic arrhythmia detection
`based on time and time-frequency analysis of heart rate
`variability. Comput Methods Programs Biomed. 2004 May;
`74(2):95-108 (“Tsipouras-2004”)
`
`APPLE-1013
`
` Lu S, Zhao H, Ju K, Shin K, Lee M, Shelley K, Chon KH. Can
`photoplethysmography variability serve as an alternative
`approach to obtain heart rate variability information? J Clin
`
`iii
`
`

`

`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`Monit Comput. 2008 Feb; 22(1):23-9 (“Lu-2008”)
`
`APPLE-1014
`
` Selvaraj N, Jaryal A, Santhosh J, Deepak KK, Anand S.
`Assessment of heart rate variability derived from finger-tip
`photoplethysmography as compared to electrocardiography. J
`Med Eng Technol. 2008 Nov-Dec; 32(6):479-84 (“Selvaraj-
`2008”)
`
`APPLE-1015
`
` Lu G, Yang F, Taylor JA, Stein JF. A comparison of
`photoplethysmography and ECG recording to analyse heart rate
`variability in healthy subjects. J Med Eng Technol. 2009;
`33(8):634-41 (“Lu-2009”)
`
`APPLE-1016
`
` Suzuki T, Kameyama K, Tamura T. Development of the
`irregular pulse detection method in daily life using wearable
`photoplethysmographic sensor. Annu Int Conf IEEE Eng Med
`Biol Soc. 2009; 2009:6080-3 (“Suzuki-2009”)
`
`APPLE-1017
`
` Reed MJ, Robertson CE, Addison PS. Heart rate variability
`measurements and the prediction of ventricular arrhythmias.
`QJM. 2005 Feb;98(2):87-95 (“Reed-2005”)
`
`APPLE-1018
`
` Schäfer A, Vagedes J. How accurate is pulse rate variability as
`an estimate of heart rate variability? A review on studies
`comparing photoplethysmographic technology with an
`electrocardiogram. Int J Cardiol. 2013 Jun 5; 166(1):15-29
`(“Schafer-2013”)
`
`APPLE-1019
`
` K. Douglas Wilkinson, “The Clinical Use of the
`Sphygmomanometer,” The British Medical Journal, 1189-90
`(Dec. 27, 1924) (“Wilkinson”)
`
`APPLE-1020
`
` U.S. Patent 6,095,984 (“Amano”)
`
`APPLE-1021
`
` B.K. Bootsma et. al, “Analysis of R-R intervals in patients with
`atrial fibrillation at rest and during exercise.” Circulation 1970;
`41:783-794 (“Bootsama-1970”)
`
`iv
`
`

`

`APPLE-1022
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
` Frits L. Meijler and Fred H. M. Wittkampf, “Role of the
`Atrioventricular Node in Atrial Fibrillation” Atrial Fibrillation:
`Mechanisms and Management, 2nd ed. 1997 (“Meijler-1997”)
`
`APPLE-1023
`
` Heart Diseases, Definition of Heart Diseases by Merriam-
`Webster Dictionary
`
`APPLE-1024
`
` Acharya UR, Joseph KP, Kannathal N, Lim CM, Suri JS. Heart
`rate variability: a review. Med Biol Eng Comput. 2006 Dec;
`44(12):1031-51 (“Acharya-2006”)
`
`APPLE-1025
`
` Saime Akdemir Akar, Sadık Kara, Fatma Latifoğlu, Vedat
`Bilgiç. Spectral analysis of photoplethysmographic signals: The
`importance of preprocessing. Biomedical Signal Processing and
`Control, 2013; 8(1):16-22 (Akar-2013)
`
`APPLE-1026
`
` U.S. Provisional Application No. 61/915,113
`
`APPLE-1027
`
` U.S. Provisional Application No. 61/953,616
`
`APPLE-1028
`
` U.S. Provisional Application No. 61/969,019
`
`APPLE-1029
`
` U.S. Provisional Application No. 61/970,551
`
`APPLE-1030
`
` U.S. Provisional Application No. 62/014516
`
`APPLE-1031
`
` U.S. Patent Publication No. 2012/0203491 (“Sun”)
`
`APPLE-1032
`
` U.S. Patent 9,808,206 (“Zhao”)
`
`APPLE-1033
`
` Kleiger RE, Stein PK, Bigger JT Jr. Heart rate variability:
`measurement and clinical utility. Ann Noninvasive
`Electrocardiol. 2005 Jan; 10(1):88-101 (“Kleiger-2005”)
`
`APPLE-1034
`
` Chen Z, Brown EN, Barbieri R. Characterizing nonlinear
`heartbeat dynamics within a point process framework. IEEE
`Trans Biomed Eng. 2010 Jun; 57(6):1335-47 (“Chen-2010”)
`
`v
`
`

`

`APPLE-1035
`
`APPLE-1036
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
` Karvonen, J., Vuorimaa, T. Heart Rate and Exercise Intensity
`During Sports Activities. Sports Medicine 5, 303–311 (1988)
`(“Karvonen-1988”)
`
` Yu C, Liu Z, McKenna T, Reisner AT, Reifman J. A method
`for automatic identification of reliable heart rates calculated
`from ECG and PPG waveforms. J Am Med Inform Assoc. 2006
`May-Jun; 13(3):309-20 (“Yu-2006”)
`
`APPLE-1037
`
` AliveCor v Apple ITC Complaint Exhibit 10 (941 Infringement
`Chart)
`
`APPLE-1038
`
` Tavassoli, M, Ebadzadeh, MM, Malek H. (2012). Classification
`of cardiac arrhythmia with respect to ECG and HRV signal by
`genetic programming. Canadian Journal on Artificial
`Intelligence, Machine Learning and Pattern Recognition. 3. 1-
`13 (“Tavassol-2012”)
`
`APPLE-1039
`
` Asl BM, Setarehdan SK, Mohebbi M. Support vector machine-
`based arrhythmia classification using reduced features of heart
`rate variability signal. Artif Intell Med. 2008 Sep;44(1):51-64
`(“Asl-2008”)
`
`APPLE-1040
`
` Yaghouby F., Ayatollahi A. (2009) An Arrhythmia
`Classification Method Based on Selected Features of Heart
`Rate Variability Signal and Support Vector Machine-Based
`Classifier. In: Dössel O., Schlegel W.C. (eds) World Congress
`on Medical Physics and Biomedical Engineering, September 7 -
`12, 2009, Munich, Germany. IFMBE Proceedings, vol 25/4.
`Springer, Berlin, Heidelberg (“Yaghouby-2009”)
`
`APPLE-1041
`
` Dallali, A, Kachouri, A, Samet, M. (2011). Integration of HRV,
`WT and neural networks for ECG arrhythmias classification.
`ARPN Journal of Engineering and Applied Sciences. VOL. 6.
`74-82 (“Dallali-2011”)
`
`vi
`
`

`

`APPLE-1042
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
` Sajda P. Machine learning for detection and diagnosis of
`disease. Annu Rev Biomed Eng. 2006; 8:537-65 (“Sajda-
`2006”)
`
`APPLE-1043
`
` Aaron Smith. Smartphone Ownership – 2013 Update. Pew
`Research Center. June 5, 2013 (“Smith-2013”)
`
`APPLE-1044
`
` C. Narayanaswami and M. T. Raghunath, “Application design
`for a smart watch with a high resolution display,” Digest of
`Papers. Fourth International Symposium on Wearable
`Computers, 2000, pp. 7-14 (“Narayanaswami-2000”)
`
`APPLE-1045
`
` Thong, YK, Woolfson, M, Crowe, JA, Hayes-Gill, B, Challis,
`R. (2002). Dependence of inertial measurements of distance on
`accelerometer noise, Meas. Measurement Science and
`Technology. 13. 1163 (“Thong-2002”)
`
`APPLE-1046
`
` AliveCor’s ITC Complaint filed on April 20, 2021 in “Certain
`Wearable Electronic Devices With ECG Capability and
`Components Thereof” ITC-337-3545-20210420 (“ITC
`Complaint”)
`
`
`APPLE-1047
`
` Excerpts from Marcovitch, Harvey. Black’s Medical
`Dictionary. London: A. & C. Black, 2005
`
`APPLE-1048
`
` U.S. Patent No. 7,894,888 (“Chan”)
`
`APPLE-1049
`
` Discordance, Definition of Discordance by Merriam-Webster
`Dictionary
`
`APPLE-1050
`
` Strath SJ, Swartz AM, Bassett DR Jr, et al. Evaluation of heart
`rate as a method for assessing moderate intensity physical
`activity. Medicine and Science in Sports and Exercise. 2000
`Sep; 32(9 Suppl):S465-70 (“Strath-2000”)
`
`APPLE-1051
`
`Letter from Michael Amon re Conditional Stipulation dated
`June 8, 2021
`
`vii
`
`

`

`APPLE-1052
`
`APPLE-1053
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`Declaration of Mr. Jacob Munford
`
`Order Staying Case Pending Institution of And/Or Final
`Determination in Parallel ITC Matter (AliveCor Inc. v. Apple
`Inc., 6:20-cv-01112-26 (W.D.Tex. May 6, 2021)
`
`APPLE-1054
`
` U.S. Provisional Application No. 61/895,995 (“Martin
`Provisional”)
`
`APPLE-1055
`
` AliveCor’s District Court Complaint filed on May 25, 2021 in
`AliveCor, Inc. v. Apple Inc., 3:21-cv-03958 (N.D.Cal. May 25,
`2021) (“Antitrust Complaint”)
`
`viii
`
`

`

`Apple petitions for Inter Partes Review of claims 1-23 (“Challenged
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`Claims”) of U.S. Patent No. 10,638,941 (“the ’941 patent”).
`
`I.
`
`REQUIREMENTS
`A. Grounds for Standing
`Apple certifies that the ’941 patent is available for IPR. This petition is
`
`being filed within one year of service of a complaint against Apple. Apple is not
`
`barred or estopped from requesting this review.
`
`B. Challenge and Relief Requested
`Apple requests IPR and cancellation of the Challenged Claims on the
`
`grounds below, which are supported by a declaration from Dr. Bernard Chaitman1
`
`(APPLE-1003).
`
`Ground
`1
`
`2
`3
`
`Claims
`1, 5, 7-9, 11, 12, 16, 18-20,
`22, 23
`2-4, 6, 13-15, 17
`10, 21
`
`Basis
`§103: Shmueli, Osorio
`
`§103: Shmueli, Osorio, Lee-2013
`§103: Shmueli, Osorio, Chan
`
`The ’941 patent was filed 10/11/2018, and claims priority to 5/13/2015
`
`(“Critical Date”). Apple does not concede that the Challenged Claims are entitled
`
`to the claimed priority, but applies prior art before the alleged date. APPLE-1003,
`
`
`1 Dr. Chaitman is a distinguished scholar and cardiologist.
`
`1
`
`

`

`¶¶9, 11. Applied references are prior art on the bases below:
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`Reference
`Shmueli
`Osorio
`
`Lee-2013
`Chan
`
`Date(s)
`10/18/2012
`9/18/2014
`3/13/2014
`20132
`2/22/2011
`
`Basis
`§102(a)(1)
`§102(a)(1)
`§102(a)(2)
`§102(a)(1)
`§102(a)(1)
`
`II. TECHNOLOGY OVERVIEW AND THE ’941 PATENT
`A. Arrhythmia
`Cardiac arrhythmias refer to a group of disorders of the heart rate or heart
`
`rhythm. APPLE-1003, ¶26. Arrhythmic activity can include the heart beating too
`
`fast (tachycardia), too slow (bradycardia), or irregularly (variations in heart rate).
`
`Id. While tachycardia and bradycardia may be diagnosed based on heart rate,
`
`variations in heart rate (e.g., atrial fibrillation) are diagnosed based on heart rate
`
`variability analysis. APPLE-1003, ¶26; APPLE-1012, Abstract.
`
`Since 1903, different detection techniques have been employed to detect
`
`irregular heartbeats. APPLE-1019; APPLE-1020, 9:12-28. By 1977, both
`
`detecting atrial fibrillation using irregular heartbeats and techniques to
`
`quantitatively characterize irregularities were well-known. APPLE-1003, ¶27. By
`
`2009, examples of known arrhythmia detection techniques included: neural
`
`
`2 APPLE-1052, ¶¶12-16 (authenticating public availability date).
`
`2
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`

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`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
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`networks, wavelet transforms, support vector machines, fuzzy logic, and rule-based
`
`algorithms. APPLE-1040, 1928.
`
`B.
`Electrocardiography (ECG)
`ECG measures electrical activity of the heart, which can be indicative of
`
`heart diseases. APPLE -1004, 1:14-17. ECG recording uses Ag/AgCl electrodes
`
`attached to specific anatomical positions. APPLE-1015, 635; APPLE-1003, ¶28.
`
`An ECG represents electrical activity of the heart based on depolarization
`
`and repolarization of the atria and ventricles, which typically show up as five
`
`distinct waves on the ECG readout—P-wave, Q-wave, R-wave, S-wave, and T-
`
`wave. A QRS complex is a combination of the Q, R, and S waves occurring in
`
`succession. Id. An R-R interval represents a time elapsed between successive R-
`
`waves of a QRS complex that occur between successive heart beats. Id. If R-R
`
`intervals are close to one another in value, then ventricular rhythm is understood to
`
`be “regular.” APPLE-1022, 110-112. In contrast, if significant variations in the R-
`
`R intervals exist, then the ventricular rhythm is understood to be “irregular.” Id.;
`
`APPLE-1003, ¶29.
`
`Conventionally, ECG at a hospital is used for diagnosis of arrhythmia.
`
`APPLE-1016, 6080. As an irregular heartbeat does not necessarily occur during
`
`examination at the hospital, a Holter device has been used for measuring ECG in
`
`daily life. Id. A Holter device is not ideal because it requires attaching electrodes
`
`3
`
`

`

`to the patients’ chest. Id. A Holter device typically only monitors the patient for a
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`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
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`certain period (e.g., 24 hours, 48 hours, 72 hours) and may not detect a cardiac
`
`arrhythmia if it does not occur during the monitoring period. APPLE-1004, 1:26-
`
`2:3; APPLE-1003, ¶30.
`
`C.
`Photoplethysmography (PPG)
`PPG is a noninvasive optical technique for monitoring beat-to-beat relative
`
`blood volume changes in the microvascular bed of peripheral tissues. APPLE-
`
`1014, 479. PPG also is referred to as blood oxygen saturation, pulse oximeter,
`
`oximetry, and SpO2. APPLE-1004, 7:25-27. Its basic principle requires a light
`
`source to illuminate subcutaneous tissue and a photo detector with spectral
`
`characteristics matching those of the light source. APPLE-1018, 16; APPLE-1003,
`
`¶31.
`
`As the pulse period derived from PPG data is directly related to cardiac
`
`activity, the information derived from RR intervals of ECG can also be derived
`
`from the pulse period of a PPG reading. APPLE-1014, 480. This is because
`
`electrical activity of the heart (ECG) is followed by spread of the pulsatile wave of
`
`blood to the periphery (PPG). APPLE-1014, 480. Thus, a PPG signal includes
`
`information about both heart rate and heart rate variability. APPLE-1025, 16.
`
`Many studies verify the high correlation between RR intervals (RRI) obtained from
`
`ECG and PP intervals (PPI) obtained from PPG. APPLE-1025, 16; APPLE-1018,
`
`4
`
`

`

`Fig. 1; APPLE-1003, ¶32.
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`APPLE-1018, Fig. 1
`
`
`
`Compared to ECG, PPG only requires attaching a single sensor. APPLE-1018, 16;
`
`APPLE-1003, ¶32.
`
`D. Heart Rate (HR)
`HR is the reciprocal of RR interval and measures the number of heartbeats
`
`per unit of time. APPLE-1034, 5. It was long recognized that an individual’s heart
`
`rate varies with his/her activity level (exercise intensity). APPLE-1035, 303. An
`
`individual’s heart rate can be determined using either ECG or PPG data. APPLE-
`
`1036, Abstract, Fig. 1; APPLE-1003, ¶33.
`
`E. Heart Rate Variability (HRV)
`HRV is the variation of RR intervals with respect to time and reflects beat-
`
`5
`
`

`

`to-beat HR alterations. APPLE-1025, 16; APPLE-1012, 95. HRV analysis is an
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`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`important tool in cardiology for the diagnosis of heart diseases, such as arrhythmia.
`
`APPLE-1012, Abstract, 95-96. HRV analysis has become popular because HR is a
`
`nonstationary signal and its variation may indicate heart disease. APPLE-1024,
`
`Abstract; APPLE-1003, ¶34.
`
`By the Critical Date, accurate HRV determination was known based on
`
`either ECG or PPG data. APPLE-1013, Abstract; APPLE-1014, Abstract; APPLE-
`
`1015, Abstract; APPLE-1033, 88; APPLE-1003, ¶¶35-36.
`
`
`
`F.
`’941 Patent
`The ’941 patent relates to cardiac monitoring to sense the presence of an
`
`intermittent arrhythmia in an individual. APPLE-1001, Abstract. Examples of
`
`intermittent arrhythmia identified in the ’941 patent include atrial fibrillation and
`
`supraventricular tachycardia. Id., 1:17-22; APPLE-1003, ¶37.
`
`Figure 7 depicts an example of a technique for discordance monitoring. The
`
`technique involves sensing a user’s HR and activity level at step 700. APPLE-
`
`1001, 14:48-58. The HR and activity levels are then compared to determine
`
`whether they are in discordance with each other. Id. The ’941 patent describes
`
`that “[a] discordance may be identified when a first sensed parameter value would
`
`not be expected to coincide with a second sensed parameter value.” Id., 12:55-65.
`
`Figure 7 illustrates five examples of monitoring scenarios, four of which involve
`
`6
`
`

`

`determining presence of a discordance (red) and one of which does not (green).
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`APPLE-1003, ¶38.
`
`
`
`APPLE-1001, Fig. 7 (annotated)
`
`A presence of a discordance is determined at step 702 since “elevated heart rate
`
`does [not] [sic] match the sensed stable activity level.” APPLE-1001, 14:59-15:21.
`
`In contrast, no presence of discordance is determined at step 708 since “an
`
`increased heart rate is sensed together with an increased activity level,” which
`
`7
`
`

`

`results in a determination in step 714 that the user is probably exercising. Id.,
`
`Attorney Docket No. 50095-0034IP1
`IPR of U.S. Patent No. 10,638,941
`
`
`15:44-48; APPLE-1003, ¶39.
`
`G.
`Prosecution History
`During prosecution of the ’941 patent, the Examiner rejected the claims over
`
`U.S. Pub. No. 2015/0122018 (“Yuen”) and U.S. Pub. No. 2014/0276154 (“Katra”).
`
`APPLE-1002, 135-145. During prosecution, the examiner did not consider or
`
`substantively apply any of Shmueli, Osorio, Lee-2013, or Chan, which in
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`combination render the Challenged Claims obvious. APPLE-1003, ¶¶40-45.
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`H. Claim Construction
`All claim terms should be construed according to the Phillips standard.
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`Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005); 37 C.F.R. §42.100.
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`Additionally, “claim terms need only be construed to the extent necessary to
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`resolve the controversy.” Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355,
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`1361 (Fed. Cir. 2011).
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`1.
`“Discordance” (Claims 1, 12)
`Under Philips, this term should be construed as “when a first sensed
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`parameter value would not be expected to coincide with a second sensed parameter
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`value.” APPLE-1001, 12:55-57. This construction is consistent with intrinsic
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`evidence since it is from the text of the ’941 patent itself. APPLE-1003, ¶46.
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`The ’941 patent describes examples of “discordance” consistent with this
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`construction, such as “an elevated heart rate [that] would not be expected to be
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`present with a normal or resting activity level and thus the two values are in
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`discordance with one another.” Id., 12:57-65. The construction is also consistent
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`with each of the four examples of discordances that are identified to be present in
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`monitoring scenarios shown in the ’941 patent’s Figure 7.
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`APPLE-1001, Fig. 7 (annotated)
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`At step 702, “elevated heart rate does [not] [sic] match the sensed stable activity
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`9
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`level.” APPLE-1001, 14:59-15:21. Likewise, at step 704, an “increased heart rate
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`and HRV are in discordance with the normal or resting activity level, and a
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`presence of a discordance is determined.” Id., 15:22-27. At step 706, “increased
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`heart rate, decreased heart rate variability, and normal or resting activity level are
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`in discordance.” Id., 15:33-43. At step 710, “a regular heart rate is sensed (e.g.,
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`60-100 beats per minute) and an increased heart rate variability is sensed together
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`with a normal or resting activity level,” which results in a determination of
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`discordance. Id., 15:49-59. In each of these four monitoring scenarios, a first
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`sensed parameter value (e.g., HR value, HRV value) would not be expected to
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`coincide with a second sensed parameter value (e.g., activity level value). APPLE-
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`1003, ¶47.
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`The construction is also consistent with the ordinary meaning of
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`“discordance” since it is consistent with its dictionary definition, which is “lack of
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`agreement or harmony.” APPLE-1049, 2. A person of ordinary skill in the art
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`(“POSITA”)3 would have understood that a first sensed parameter not being
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`expected to coincide with a second sensed parameter value means that there is a
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`lack of agreement or harmony between the two sensed parameters. APPLE-1003,
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`¶48.
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`3 APPLE-1003, ¶10 (defining a POSITA).
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`III. THE CHALLENGED CLAIMS ARE UNPATENTABLE4
`A.
`[GROUND 1] – Shmueli and Osorio Make Claims 1, 5, 7-9,
`11, 12, 16, 18-20, 22, And 23 Obvious
`1.
`Shmueli
`(a) Monitoring Device
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`Shmueli’s heart monitoring device includes oximetry measuring unit 13 for
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`measuring oxygen saturation (SpO2), which Shmueli describes as being the same
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`as PPG (§II.C). APPLE-1004, 7:25-27. The heart monitoring device also includes
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`ECG measuring unit 31 with electrical contacts for measuring ECG, and processor
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`29 to control both types of measurements. Id., 4:1-9, 9:8-16, 11:10-21; APPLE-
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`1003, ¶49.
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`Shmueli’s heart monitoring device has a wrist-mounted form factor.
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`APPLE-1004, FIGS. 1A, 1B, 2-5; APPLE-1003, ¶50.
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`4 Apple understands that challenges for failure to meet §112 cannot be brought in
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`this forum. Apple is not waiving any arguments under §112 or arguments regard-
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`ing claim scope.
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`11
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`APPLE-1004, Figs. 1A, 1B (annotated)
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`
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`Figure 3 shows an example of a user using Shmueli’s heart monitoring
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`device on his/her wrist to collect an ECG measurement. APPLE-1003, ¶51.
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`
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`APPLE-1004, Fig. 3 (annotated)
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`(b) Monitoring Technique
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`Shmueli’s heart monitoring device performs a technique that involves
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`“continuously measuring [oxygen saturation (SpO2)] at the wrist of the user,
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`detecting an irregular heart condition from the SpO2 measurement, notifying the
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`user to perform an ECG measurement, and initiating the ECG measurement at least
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`partially at the wrist.” APPLE-1004, Abstract. As discussed in §II.C, PPG also is
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`referred to as pulse oximetry SpO2 (oxygen saturation). APPLE-1004, 7:25-27.
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`The Merriam-Webster Dictionary defines “heart disease” as “an abnormal
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`condition of the heart or of the heart and circulation (such as coronary heart
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`disease, arrhythmia, or heart-valve defect).” APPLE-1023, 2. Likewise, the ’941
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`patent describes arrhythmia as “[i]rregular heartbeats” that “are associated with
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`significant morbidity and mortality in patients.” APPLE-1001, 1:17-18. Similarly,
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`the Black Medical Dictionary lists arrhythmia as the first condition under the
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`heading “Heart, Disease of.” APPLE-1047, 320-321; APPLE-1003, ¶¶52-53.
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`A POSITA would have understood that the term “irregular heart condition”
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`refers to arrhythmia for several reasons. First, Shmueli supports this as it discloses
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`both detecting the “irregular heart condition” based on PPG data and confirming
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`the diagnosis with an ECG measurement. APPLE-1004, Abstract, FIG. 8; 8:23-28.
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`Shmueli also recognizes that “[d]eriving heart rate from oximetry” was known in
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`the art and was commonly understood to be used in detection of arrhythmias.
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`APPLE-1004, 12:14-22. Shmueli also offers an expansive definition of the
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`“irregular heart condition.” Id., 15:3-5; APPLE-1003, ¶54.
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`Moreover, Dr. Chaitman explains that, although “irregular heart condition”
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`is not a standard term in medicine, a POSITA would have understood that this term
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`refers to arrhythmia, which is one of the most obvious (if not the most obvious)
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`types of “irregular heart condition[s]” that can be determined using PPG and ECG
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`data. APPLE-1016, 6081; APPLE-1020, Abstract, 44:29-32; APPLE-1011,
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`Abstract; APPLE-1003, ¶55.
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`Like the ’941 patent, Shmueli’s heart monitoring device detects arrhythmia
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`using PPG. APPLE-1004, Abstract. Shmueli’s Figure 7 provides an example of
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`its cardiac monitoring technique.
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`APPLE-1004, Fig. 7 (annotated)
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`Shmueli’s heart monitoring device uses PPG data to detect an irregular heart
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`condition (arrhythmia) at elements 37-38. APPLE-1004, 12:9-22. If arrhythmia is
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`detected at element 40, the heart monitoring device triggers an ECG measurement
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`at element 41 by providing a notification to the user to take the ECG measurement
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`at element 42. Id., 12:23-32; APPLE-1003, ¶56.
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`A POSITA would have understood and/or found obvious that the monitoring
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`technique shown in Shmueli’s Figure 7 contemplates using ECG data to confirm
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`the initial detection of an irregular heart condition using PPG data. APPLE-1004,
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`8:24-29. This is because Shmueli criticizes other heart monitoring devices for “not
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`consider[ing] a requirement to enable a patient to perform ECG measurement as
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`soon as an irregular heart activity develops and without requiring the ECG to be
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`constantly wired to the patient.” Id., 8:21-24. A POSITA would have recognized
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`that Shmueli’s focus on enabling ECG measurements “as soon as” an irregular
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`heart condition is detected enables ECG data to be used to confirm the detection of
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`the irregular heart condition using PPG data, thereby improving detection accuracy
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`compared to prior art heart monitoring devices. APPLE-1004, 13:16-21; APPLE-
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`1003, ¶57.
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`2. Osorio
`Osorio’s monitoring technique includes receiving a body signal of the
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`patient and determining a body data variability (BDV) from the body signal.
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`APPLE-1005, Abstract, [0003]. Osorio describes the body signal as HR and the
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`BDV as HRV. Id., [0042]-[0043]. Osorio’s monitoring technique also includes
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`determining an activity level of a patient based on data from an activity sensor
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`(e.g., accelerometer). Id., [0035]. Osorio describes detecting a pathological state
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`(e.g., arrhythmia) by comparing the current BDV value to a BDV non-pathological
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`range that is determined based on the activity level. Id., [0003]; APPLE-1003,
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`¶58. Figure 8 shows an example of Osorio’s monitoring technique:
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`APPLE-1005, Fig. 8 (annotated)
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`An activity level is determined at 810, and a non-pathological BDV range is
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`determined at 820 based on the activity level. APPLE-1005, [0077]. A current
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`BDV is determined at 840 and compared to the non-pathological BDV range at
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`850. APPLE-1005, [0078]. If the current BDV is outside the non-pathological
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`range, then a pathological state is determined at 860. Id. Thereafter, a further
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`action, such as warning, treating, or logging the occurrence and/or severity of the
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`pathological state is taken at 870. Id.; APPLE-1003, ¶59.
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`Osorio’s detection of a pathological state encompasses detecting arrhythmia.
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`APPLE-1005, [0046], [0071]. A POSITA would have therefore understood and/or
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`found obvious that Osorio’s detection of a pathological state involves detecting an
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`arrhythmia. APPLE-1003, ¶60.
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`Osorio explains that accurate detection of a pathological condition (e.g.,
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`arrhythmia) based on a patient’s HR should also consider the patient’s activity
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`level:
`
`This disclosure recognizes that to determine (using body systems and
`their features) whether a body system is functioning pathologically