`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
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`
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`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`
`
`
`
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`ALIVECOR, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2021-00972
`Patent 10,638,941
`
`
`
`
`
`
`
`
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S RESPONSE
`
`
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
`
`
`LIST OF EXHIBITS
`
`APPLE-1001
`
`U.S. Pat. No. 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. Atrial
`fibrillation detection using a smart phone. 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
`
`i
`
`
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
`photoplethysmography variability serve as an alternative
`approach to obtain heart rate variability information? J Clin
`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. Pat. No. 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
`
`ii
`
`
`
`APPLE-1022
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
` 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”)
`
`APPLE-1023
`
` Heart Diseases _ Definition of Heart Diseases by Merriam-
`Webster
`
`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 No. 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”)
`
`iii
`
`
`
`APPLE-1035
`
`APPLE-1036
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
` 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 11 (499 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 (“TavassoLi-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”)
`
`APPLE-1042
`
` Sajda P. Machine learning for detection and diagnosis of
`disease. Annu Rev Biomed Eng. 2006; 8:537-65 (“Sajda 2006”)
`
`iv
`
`
`
`APPLE-1043
`
`APPLE-1044
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
` Aaron Smith. Smartphone Ownership – 2013 Update. Pew
`Research Center. June 5, 2013 (“Smith 2013”)
`
` 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. Pat. No. 7,894,888 (“Chan”)
`
`APPLE-1049
`
` Hu YH, Palreddy S, Tompkins WJ. A patient-adaptable ECG
`beat classifier using a mixture of experts approach. IEEE
`Transactions on Bio-medical Engineering. 1997 Sep;
`44(9):891-900 (“Hu-1997”)
`
`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 4, 2021
`
`APPLE-1052
`
`Declaration of Mr. Jacob Munford
`
`
`
`v
`
`
`
`APPLE-1053
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
` 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”)
`
`APPLE-1056
`
` Apple’s Rebuttal Markman Brief of October 13, 2021
`
`APPLE-1057
`
` Email from Jeremy Monaldo re Prior Art Narrowing dated
`November 17, 2021
`
`APPLE-1058
`
` Declaration of Michael Amon
`
`APPLE-1059
`
` Declaration of Noah Graubart
`
`APPLE-1060
`
` U.S. Pat. No. 5,176,137 to Erickson et al. (“Erickson”)
`
`APPLE-1061
`
` U.S. Pat. No. 7,598,878 to Goldreich (“Goldreich”)
`
`APPLE-1062
`
` U.S. Pat. App. Pub. No. 2005/0177051 to Almen (“Almen”)
`
`APPLE-1063
`
` U.S. Pat. App. Pub. No. 2019/0376014 to Efimov (“Efimov”)
`
`APPLE-1064
`
`
`
`International App. Pub. No. WO 2005/110238 to Goldreich
`(“Goldreich-2”)
`
`
`
`APPLE-1065
`
` Yang et al., “Hardware-Mappable Cellular Neural Networks for
`Distributed Wavefront Detection in Next-Generation Cardiac
`Implant,” Adv. Intell. Syst. 2022, 2200032 (2022)
`
`APPLE-1066
`
`
`
`“Atrial fibrillation (part 1) – When the heart loses its rhythm,”
`https://www.hirslanden.com/en/international/private-hospital-
`
`vi
`
`
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`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
`group/news/artikel-vorhofflimmern-i.html, accessed June 2,
`2022
`
`APPLE-1067
`
`
`
`“Holter heart monitor,”
`https://medlineplus.gov/ency/imagepages/8810.htm, accessed
`June 2, 2022
`
`APPLE-1068
`
`“Holter monitor (24h),” https://www.mountsinai.org/health-
`library/tests/holter-monitor-24h, accessed June 22, 2022
`
`APPLE-1069
`
`
`
`June 3, 2022 Deposition Transcript of Dr. Igor Efimov
`
`APPLE-1070
`
` AliveCor’s ITC Post-Hearing Brief (CBI Redacted), dated
`April 15, 2022
`
`APPLE-1071
`
`
`
`January 31, 2022 ITC Deposition Transcript of Dr. Igor Efimov
`
`APPLE-1072
`
`
`APPLE-1073
`
`
`APPLE-1074
`
`Excerpts from Transcript of Conference in Certain Wearable
`Electronic Devices with ECG Functionality and Components
`Thereof, 337-TA-1266, dated March 31, 2022 (pages 828-1101)
`
`Excerpts from Transcript of Conference in Certain Wearable
`Electronic Devices with ECG Functionality and Components
`Thereof, 337-TA-1266, dated April 1, 2022 (pages 1102-1375)
`
` Li, Qiao, and Gari D. Clifford. "Dynamic time warping and
`machine learning for signal quality assessment of pulsatile
`signals." Physiological measurement 33.9 (2012): 1491 (“Li
`and Clifford”).
`
`APPLE-1075
`
` Schlesinger, Daphne E., and Collin M. Stultz. "Deep learning
`for cardiovascular risk stratification." Current Treatment
`Options in Cardiovascular Medicine 22.8 (2020): 1-14.
`
`APPLE-1076
`
` D’Agostino Sr, Ralph B., et al. "General cardiovascular risk
`profile for use in primary care: the Framingham Heart Study."
`Circulation 117.6 (2008): 743-753.
`
`vii
`
`
`
`APPLE-1077
`
`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
` Antman, Elliott M., et al. "The TIMI risk score for unstable
`angina/non–ST elevation MI: a method for prognostication and
`therapeutic decision making." Jama 284.7 (2000): 835-842.
`
`APPLE-1078
`
` Morrow, David A., et al. "Application of the TIMI risk score
`for ST-elevation MI in the National Registry of Myocardial
`Infarction 3." Jama 286.11 (2001): 1356-1359.
`
`APPLE-1079
`
` Pocock, Stuart J., et al. "Predicting survival in heart failure: a
`risk score based on 39 372 patients from 30 studies." European
`heart journal 34.19 (2013): 1404-1413.
`
`APPLE-1080
`
` Yu, Chenggang, et al. "A method for automatic identification of
`reliable heart rates calculated from ECG and PPG waveforms."
`Journal of the American Medical Informatics Association 13.3
`(2006): 309-320.
`
`APPLE-1081
`
` December 22, 2021 Collin Stultz ITC Invalidity Report
`(Redacted)
`
`APPLE-1082
`
` February 3, 2022 Deposition Transcript of Collin Stultz (ITC).
`
`APPLE-1083
`
` RDX-0003 Stultz Demonstratives (ITC)
`
`APPLE-1084
`
` APPLE’s ITC Post-Hearing Brief (CBI Redacted), dated April
`15, 2022
`
`APPLE-1085
`
` Bansal, Nikhil, Avrim Blum, and Shuchi Chawla. "Correlation
`clustering." Machine learning 56.1 (2004): 89-113.
`
`
`
`
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`
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`viii
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`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
`TABLE OF CONTENTS
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`THE PRIOR ART RENDERS ARRHYTHMIA DETECTION OBVIOUS .. 3
`A. Record Evidence Confirms Obviousness ................................................... 3
`1. Testimony From Both Experts Reinforce the Petition .......................... 4
`2. Shmueli And The ’941 Patent Both Reinforce The Petition .................. 6
`3. Secondary Evidence Also Reinforces The Petition ............................. 10
`B. AliveCor’s Response Arguments Fail ...................................................... 11
`1. AliveCor’s Interpretation of Shmueli Deviates From its Disclosure ... 11
`2. AliveCor Ignores Non-Limiting Language In Osorio .......................... 15
`SHMUELI RENDERS “CONFIRMATION” OBVIOUS ............................ 18
`A. Shmueli Renders Obvious “Confirming” Based on ECG Data ............... 18
`B. Shmueli Correlates ECG Data and SpO2/PPG Data ................................ 20
`C. Shmueli’s Continued SpO2/PPG Monitoring Is Limited to
`Embodiments ............................................................................................ 22
`D. Shmueli Is Not Limited to Remote ECG Analysis .................................. 23
`IV. A POSITA WOULD HAVE BEEN MOTIVATED TO COMBINE
`SHMEULI AND OSORIO ............................................................................ 23
`THE “ATRIAL FIBRILLATION” CLAIMS ARE OBVIOUS ................... 25
`A. AliveCor’s Argument Is Legally Deficient .............................................. 25
`B. AliveCor’s Other Arguments Are Ineffective .......................................... 25
`VI. ALIVECOR’S “POSITA” DEFINITION IS WRONG ................................ 27
`VII. CONCLUSION .............................................................................................. 28
`
`III.
`
`V.
`
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`Case IPR2021-00972
`Attorney Docket No: 50095-0034IP1
`
`I.
`
`INTRODUCTION
`For the independent claims of the ’941 patent, AliveCor’s Response repeats
`
`the same three arguments that were raised pre-institution and that were rejected in
`
`the Institution Decision. AliveCor contends that the post-institution record
`
`warrants reconsideration of these preliminary findings. Not so. If anything, the
`
`record evidence reinforces the obviousness arguments provisionally adopted in the
`
`Institution Decision. Testimony from AliveCor’s own expert, Igor Efimov,
`
`includes several admissions that contradict each of AliveCor’s primary arguments.
`
`The record evidence therefore confirms that the asserted prior art demonstrates
`
`unpatentability of claims 1-23 of the ’941 patent (“Challenged Claims”).
`
`AliveCor’s first argument is premised on a superficial distinction between
`
`Shmueli’s “irregular heart condition” and the claim term “arrhythmia.” AliveCor
`
`criticizes Shmueli for not literally using the claim term within its disclosure, but
`
`AliveCor’s analysis either overlooks or ignores several teachings that demonstrate
`
`obviousness. Indeed, AliveCor’s Dr. Efimov admitted that a POSITA would have
`
`understood that “irregular heart condition” included arrhythmia as a subcategory at
`
`the relevant time (and even today). APPLE-1069, 27:17-18.
`
`Dr. Efimov also contradicted his opinions regarding Osorio. APPLE-1069,
`
`56:23-59:9. He recognized that Osorio detects arrhythmias, but failed to offer any
`
`justification for the position that Osorio’s detection of arrhythmias is somehow
`
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`Case IPR2021-00972
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`diminished as part of its process of detecting neurological conditions. Id., 68:6-
`
`70:7. Osorio describes detecting “any pathological condition” and it is undisputed
`
`that “arrhythmia” is a pathological condition. Id., 50:17-22; 51:6-10.
`
`AliveCor’s second argument attempts to distinguish the “confirm”
`
`limitations from the prior art. Despite acknowledging that ECG is the gold
`
`standard for detecting arrhythmias (Resp. 10; APPLE-1071, 19:12-18), AliveCor
`
`argues that Shmueli limits its detection to SpO2/PPG data, even when the gold
`
`standard of ECG is available. This belies common sense and, as discussed in the
`
`Petition and reiterated below, Shmueli instructs a user to take an ECG when a
`
`problem is identified in SpO2/PPG data so that ECG data can confirm whether or
`
`not the SpO2/PPG detection was accurate. Pet. 15, 53; APPLE-1003, ¶¶57, 121;
`
`APPLE-1004, Abstract, 3:15-20, 9:21-29, 12:22-31; 14:16-21, FIG. 7. AliveCor
`
`also ignores Shmueli’s disclosure that, when a potential irregular heart condition is
`
`detected by SpO2/PPG monitoring, the system prompts the user to take an ECG
`
`and analyze ECG data alone or in correlation with SpO2/PPG data to confirm the
`
`detection. APPLE-1004, 15:1-3, 12:22-31 (“procedure for identifying correlations
`
`between Sp02 measurement and ECG measurement of a particular subject to detect
`
`user-specific irregular heart conditions.”).
`
`AliveCor’s third argument against the Shmueli-Osorio combination is
`
`similarly deficient. AliveCor does not dispute or rebut the Petition’s primary
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`Case IPR2021-00972
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`motivation for the combination—benefits of activity monitoring to detect
`
`pathological conditions, which again would have included arrhythmias. Pet., 27-
`
`31. AliveCor instead argues that Shmueli and Osorio are non-analogous—an
`
`argument that relies on an unreasonably narrow view of Osorio and on AliveCor’s
`
`other argument that neither Shmueli nor Osorio disclose arrhythmia detection.
`
`Osorio is not so limited and the other argument is flawed.
`
`AliveCor’s only new argument is that Lee 2013 discloses detecting atrial
`
`fibrillation without an ECG sensor, and that this teaches away from the Shmueli-
`
`Osorio-Lee 2013 combination. But the law is clear that a reference only teaches
`
`away when it discourages or disparages. Lee 2013 does neither.
`
`II. THE PRIOR ART RENDERS ARRHYTHMIA DETECTION
`OBVIOUS
`A. Record Evidence Confirms Obviousness
`The Petition explained that Shmueli “offers an expansive definition” of the
`
`term “irregular heart condition” and that “[a] POSITA would have understood that
`
`the term ‘irregular heart condition’ refers to arrhythmia…” Pet., 13-14 (citing
`
`APPLE-1003, ¶54). Despite AliveCor’s contrary pre-institution argument, the
`
`Institution Decision recognized that irregular heart condition “at a minimum,
`
`encompass[es]—arrhythmia, and, thus, disclos[es] the detection of arrhythmia.”
`
`Dec., 37. The post-institution record reinforces this preliminary finding.
`
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`3
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`Case IPR2021-00972
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`Testimony From Both Experts Reinforce the Petition
`1.
`AliveCor’s position relies principally on declaration testimony from Dr.
`
`Efimov. Resp., 39-45 (citing Ex. 2016, ¶¶61-66). In deposition, however, Dr.
`
`Efimov admitted that an irregular heart condition is a “general category,” and that
`
`arrhythmia is a “subcategory.” APPLE-1069, 28:3-24.1 He also confirmed that a
`
`POSITA by the Critical Date would have understood the same. Id.
`
`Dr. Chaitman’s testimony on Shmueli’s use of “irregular heart condition,” in
`
`contrast, is unrebutted; AliveCor failed to produce any evidence to the contrary. It
`
`instead concludes—without even citing to the record—that “Dr. Chaitman
`
`admitted that detection in Shmueli is performed based on the SpO2 measurement
`
`and the SpO2 measurement only.” Resp., 3. This mischaracterizes Dr. Chaitman’s
`
`testimony since AliveCor’s questions were limited to specific embodiments of
`
`Shmueli, not its entire disclosure. Ex. 2017, 71:31-90:12.
`
`With its narrow focus on SpO2 measurement, AliveCor appears to argue that
`
`Shmueli’s detection of irregular heart conditions is based exclusively on
`
`
`1 Dr. Efimov also made several factually incorrect statements. He testified that
`
`sinus tachycardia is “a symptom of a neurological system but not an arrhythmia per
`
`se[,]” which contradicts undisputed disclosures in the ’941 patent. Compare
`
`APPLE-1069, 58:1-2 and APPLE-1001, 10:26-38.
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`4
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`Case IPR2021-00972
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`monitoring blood gas composition. Resp., 30-31 (citing Ex. 2016, ¶45); Ex. 2016,
`
`¶45 (“[a] POSITA would understand Shmueli’s brief mention of PPG and
`
`continuous discussion of an SpO2 monitor to be specifically directed to
`
`monitoring blood gas composition”). However, Shmueli’s title includes “pulse
`
`oximetry,” indicating that its disclosure is not limited only to oxygen saturation
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`measurements. This is reinforced by Shmueli’s reference to “pulse oximetry,”
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`“pulse oximeter,” and “photoplethysmography,” which have uses beyond just
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`oxygen saturation measurements. APPLE-1004, Title, 8:24-30. Indeed, Dr.
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`Efimov testified that a POSITA would have understood that a “pulse oximeter”
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`includes both PPG and SpO2 sensors, and measures both pulse and blood gas.
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`APPLE-1069, 81:8-13, 83:11-25, 84:16-85:2. This is consistent with Shmueli’s
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`teaching that its device can derive “physiological parameters such as pulse rate,
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`pulse amplitude, pulse shape, rate of blood flow etc.” and “scan the derived
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`physiological parameters to detect various irregularities of the heart condition.”
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`APPLE-1004, 13:14-22. To the extent that AliveCor’s position is that Shmueli’s
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`detection of irregular heart conditions is based only on blood gas composition
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`measurements, Shmueli’s disclosure and Dr. Efimov’s testimony refute it.
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`APPLE-1069, 120:6-13.
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`AliveCor also is wrong in saying that what Shmueli describes as “SpO2
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`measurements” necessarily precludes arrhythmia detection. Dr. Efimov admitted
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`that pulse (and thus, heart rate) can be derived from pulse oximeters and SpO2
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`sensors. It is undisputed that heart rate data is used to detect arrhythmias. APPLE-
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`1069, 84:4-12, 120:6-13, 121:2-17. Dr. Chaitman similarly confirmed that
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`physiological parameters used for arrhythmia detection (pulse rate, pulse
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`amplitude, etc.) can be derived from Shmueli’s SpO2 measurements. Ex. 2017,
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`90:5-12, 120:6-13. Both parties’ experts therefore agree that data used to detect
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`arrhythmia is derived from Shmueli’s SpO2 measurements using a pulse oximeter
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`sensor, which Dr. Efimov described as measuring both pulse and blood gas.
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`APPLE-1069, 120:6-13.
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`Thus, the expert testimony contradicts AliveCor’s incorrect view of
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`Shmueli’s disclosure of SpO2 measurements, and also contradicts AliveCor’s
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`conclusion that arrhythmia detection is necessarily precluded by Shmueli’s SpO2
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`measurements.
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`Beyond expert testimony, AliveCor’s position fails to rebut or even address
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`other record evidence that reinforces the Petition: (1) disclosures in Shmueli and
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`the ’941 patent specification, and (2) secondary evidence, including references
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`cited within Shmueli.
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`Shmueli And The ’941 Patent Both Reinforce The Petition
`2.
`AliveCor broadly alleges that “Shmueli does not give a POSITA any
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`direction indicating to a POSITA that arrhythmias are included in the context of its
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`discussion.” Resp., 42. This attempt to narrow Shmueli runs contrary to express
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`descriptions within its disclosure. AliveCor tries to avoid this disclosure by
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`denying that Shmueli provides an “expansive definition”; it “merely states that
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`‘irregular heart condition’ is ‘intended to include all such new technologies a
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`priori.’” Resp., 41 (fn 2) (citing APPLE-1004, 16:3-5). AliveCor’s analysis is
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`incomplete—ignoring an earlier clause in Shmueli stating that “many relevant
`
`methods and systems will be developed and the scope of the terms herein,
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`particularly of the term irregular heart condition are intended to include all such
`
`new technologies a priori.” APPLE-1004, 16:3-5. Through this reference to
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`“irregular heart condition,” Shmueli makes clear that the term is not limited in the
`
`manner that AliveCor suggests (i.e., excluding arrhythmia). AliveCor’s position is
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`at odds with Shmueli’s own disclosure.
`
`AliveCor’s myopic view of Shmueli also causes it to ignore key discussion
`
`of the other relevant terminology cited in the Petition. Specifically, Shmueli
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`teaches “intermittently-occurring” heart-related events as one example of
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`Shmueli’s “irregular heart condition.” Pet., 49, 53; APPLE-1004, 9:24-29, 3:4-9
`
`(describing “measuring the ECG signal associated with an intermittent irregular
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`heart-related event…”). The ’941 patent specification teaches that intermittently-
`
`occurring heart-related events are examples of arrhythmias. APPLE-1001, 4:14-32
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`(“[m]any arrhythmias occur intermittently and relatively infrequently”). Thus,
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`even the ’941 patent specification supports the Petition since its descriptions of
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`“arrhythmia” comport with Shmueli’s disclosure of “intermittent irregular heart-
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`related events,” which the Petition identified as rendering arrhythmia obvious. Dr.
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`Efimov confirmed that intermittently-occurring heart conditions are well-known to
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`POSITAs as types of arrhythmias. APPLE-1069, 23:25-24:14; 30:1-5.
`
`Moreover, both Shmueli and the ’941 patent specification reinforce the
`
`Petition through analogous disclosures of the challenges with continuous cardiac
`
`monitoring when detecting intermittently-occurring heart conditions. APPLE-
`
`1004, 9:21-23 (“requir[ing] the ECG to be constantly wired to the patient” to
`
`assess ECG data “as soon as an irregular heart activity develops”); APPLE-1001,
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`4:14-32 (“ECG can be measured continuously…but this type of monitoring is
`
`cumbersome for the patient and is thus not widely used”). Shmueli then describes
`
`that its invention “resolves this problem by providing a combined oximetry and
`
`electrocardiogram measuring device” in which “oximetry measurement is
`
`performed continuously and/or repeatedly…” APPLE-1004, 9:24-29. Shmueli
`
`thereby proposes using oximetry measurement to detect intermittent irregular
`
`heart-related events or irregular heart activity “without requiring the fixed wiring
`
`of the ECG device to the patient.” Id. The ’941 patent offers essentially the same
`
`solution.
`
`Discussion of the same problem of cardiac monitoring associated with
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`detecting intermittent heart conditions—requiring continuous monitoring of the
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`user by ECG—confirms that both Shmueli and the ’941 patent contemplate
`
`techniques for detecting cardiac arrhythmias. In fact, the ’941 patent specification
`
`describes devices that are “light and portable and don’t necessarily require the user
`
`to be in continuous physical contact with one or more electrodes…” APPLE-1001,
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`4:14-32. This is precisely the type of device disclosed in Shmueli, which
`
`“preferably performs measurements of intermittent irregular heart-related events
`
`without requiring the fixed wiring of the ECG device to the patient.” APPLE-
`
`1004, 9:24-29.
`
`Moreover, both Shmueli and the ’941 patent discuss the limitations of Holter
`
`devices in the context of cardiac monitoring, further suggesting a similar focus on
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`arrhythmia detection. APPLE-1004, 2:21-3:3 (a Holter device “has a time limit of
`
`its operation[]” and that for “events that are not sufficiently frequent” (i.e.,
`
`intermittent heart-related events)); APPLE-1001, 4:14-32 (monitoring using holter
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`devices is “cumbersome for the patient and is thus not widely used”). Both Dr.
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`Efimov’s declaration and deposition testimony confirm that Holter devices are
`
`used to detect arrhythmia. APPLE-1069, 30:24-31:9; Ex. 2016, ¶7 (“Clinically,
`
`AFib is diagnosed by cardiologists using gold standard tool – 12 lead ECG, or
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`Holter monitors and similar wearable or implantable devices.”). Thus, there is no
`
`doubt that Shmueli is directed to arrhythmia detection.
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`Secondary Evidence Also Reinforces The Petition
`3.
`The Petition noted that irregular heart condition “refers to arrhythmia, which
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`is one of the most obvious (if not the most obvious) types of ‘irregular heart
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`condition[s]’ that can be determined using PPG and ECG data.” Pet., 14 (citing
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`APPLE-1003, ¶55). AliveCor concedes “an arrhythmia might be an irregular heart
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`condition.” Resp., 40. But it still contends that arrhythmia “cannot be an
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`‘irregular heart condition’ as that phrase is used in Shmueli.” Id. However,
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`secondary evidence in this record contradicts AliveCor.
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`APPLE-1066 references “irregular activity” in discussing “atrial
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`fibrillation,” which Dr. Efimov identified in deposition as the most common type
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`of diagnosed arrhythmia. APPLE-1066, 4; APPLE-1069, 23:5-9. Similarly,
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`APPLE-1067 and APPLE-1068 use the term “irregular heart activity” in reference
`
`to Holter devices, which both experts agree are used for arrhythmia detection.
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`APPLE-1067, 1; APPLE-1068, 1.
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`Shmueli also cites several background references that relate to arrhythmia
`
`detection and describes them as “the most relevant prior art.” APPLE-1004, 3:10-
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`13, 9:1-29. One example is U.S. 7,598,878 to Goldreich, which discloses a wrist-
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`worn device with a SpO2 sensor. APPLE-1061, 13:23-29. Goldreich teaches that
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`the SPO2 sensor can provide information regarding heart rate, such as a Pulse
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`Wave Transit Time (PWTT). Id., 16:54-58. Further, claim 5 of Goldreich recites
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`selection of “at least one physiological parameter” from a group that includes
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`“arrhythmia of the heart.” Id., Claim 5. Another example is an international
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`search report issued in Shmueli that also cites multiple references directed to
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`arrhythmia detection. U.S. 2005/177051 to Almen discloses a wrist-watch with
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`heart rate sensors, including an ECG and a pulse oximeter that is used to detect
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`arrhythmia. APPLE-1062, [0014], [0051], [0055], [0062].
`
`B. AliveCor’s Response Arguments Fail
`1.
`AliveCor’s Interpretation of Shmueli Deviates From its
`Disclosure
`AliveCor’s position is untenable as it requires every example of “irregular
`
`heart condition” to exclude arrhythmia. Otherwise, Shmueli renders the recited
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`arrhythmia detection obvious since the term “at a minimum, encompass[es]”
`
`arrhythmia. Dec., 37; Pet., 13-14, 53. AliveCor advances three key arguments,
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`each of which lacks evidentiary support and fails to rebut the Petition. Resp., 39-
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`45.
`
`a)
`
`AliveCor’s First Argument Confirms The Breadth of
`“Irregular Heart Condition”
`AliveCor initially states that “there is no evidence a POSITA at the time of
`
`the invention of the ’941 Patent, reading Shmueli, would have understood
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`Shmueli’s use of the phrase ‘irregular heart condition’ to include arrhythmias…”
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`Resp., 41. As discussed in Section II.A, this is wrong based on the cited evidence.
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`Beyond Shmueli, AliveCor further confirms the breadth of the term since it states
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`“there are numerous other irregular heart conditions…” Resp., 40-41. If “irregular
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`heart conditions” is understood to include “numerous” conditions and Shmueli
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`discloses detecting “various irregular heart conditions,” then it would have been
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`obvious that arrhythmia (which is the most common type of heart condition) is one
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`example of an irregular heart condition detected by Shmueli. APPLE-1004, 12:29-
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`31. AliveCor even states that irregular heart condition is a “genus” of arrhythmia.
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`Resp., 41. Thus, AliveCor acquiesces that Shmueli’s disclosure of irregular heart
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`condition renders arrhythmia detection obvious. Dec., 37.
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