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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`APPLE INC.,
`Petitioner,
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`v.
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`ALIVECOR, INC.,
`Patent Owner.
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`IPR2021-00971
`Patent 10,595,731
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`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
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`APPLE-1001
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`APPLE-1002
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`
`EXHIBIT LIST
`U.S. Pat. No. 10,595,731 to Gopalakrishnan (“the ’731 patent”)
`
`Excerpts from the Prosecution History of the ’731 patent (“the
`Prosecution History”)
`
`APPLE-1003
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`Declaration of Dr. Bernard A. Chaitman
`
`APPLE-1004
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` PCT Patent Publication WO2012/140559 (“Shmueli”)
`
`APPLE-1005
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` 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
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` U.S. Patent Publication 2015/0119725 (“Martin”)
`
`APPLE-1010
`
` U.S. Provisional Application No. 61/794,540 (“OP”)
`
`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
`photoplethysmography variability serve as an alternative
`approach to obtain heart rate variability information? J Clin
`i
`
`
`
`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”)
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`APPLE-1020
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` U.S. Pat. No. 6,095,984 (“Amano”)
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`APPLE-1021
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` 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
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`APPLE-1022
`
` Frits L. Meijler and Fred H. M. Wittkampf, “Role of the
`ii
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`
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`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)
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`APPLE-1026
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` U.S. Provisional Application No. 61/915,113
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`APPLE-1027
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` U.S. Provisional Application No. 61/953,616
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`APPLE-1028
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` U.S. Provisional Application No. 61/969,019
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`APPLE-1029
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` U.S. Provisional Application No. 61/970,551
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`APPLE-1030
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` U.S. Provisional Application No. 62/014516
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`APPLE-1031
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` U.S. Patent Publication No. 2012/0203491 (“Sun”)
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`APPLE-1032
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` U.S. Patent No. 9,808,206 (“Zhao”)
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`APPLE-1033
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` 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”)
`
`APPLE-1035
`
` Karvonen, J., Vuorimaa, T. Heart Rate and Exercise Intensity
`
`iii
`
`
`
`During Sports Activities. Sports Medicine 5, 303–311 (1988)
`(“Karvonen 1988”)
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`APPLE-1036
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` 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
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` AliveCor v Apple ITC Complaint Exhibit 11 (731 Infringement
`Chart)
`
`APPLE-1038
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` 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
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` 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
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` 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”)
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`APPLE-1042
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` Sajda P. Machine learning for detection and diagnosis of
`disease. Annu Rev Biomed Eng. 2006; 8:537-65 (“Sajda 2006”)
`
`iv
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`
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`APPLE-1043
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` Aaron Smith. Smartphone Ownership – 2013 Update. Pew
`Research Center. June 5, 2013 (“Smith 2013”)
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`APPLE-1044
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` 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
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` 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”)
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`APPLE-1046
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` 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
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` Excerpts from Marcovitch, Harvey. Black’s Medical
`Dictionary. London: A. & C. Black, 2005
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`APPLE-1048
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` 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”)
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`APPLE-1051
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`Letter from Michael Amon re Conditional Stipulation dated
`June 4, 2021
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`APPLE-1052
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`Declaration of Mr. Jacob Munford
`v
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`
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`APPLE-1053
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` 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)
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`APPLE-1054
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` U.S. Provisional Application No. 61/895,995 (“Martin
`Provisional”)
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`APPLE-1055
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` 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”)
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`APPLE-1056
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` Apple’s Rebuttal Markman Brief of October 13, 2021
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`vi
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`Apple’s diligence and strong stipulation favor institution. Specifically,
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`Apple’s diligent filing of its Petition before responding to the ITC Complaint
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`weighs in favor of institution and allows the final written decision (“FWD”) to
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`issue before or near the ITC’s target date. Apple also has eliminated overlap
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`between the PTAB and the ITC by omitting the IPR prior art from its ITC
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`invalidity contentions and stipulating that, upon institution, it will not pursue any
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`of the same prior art in both forums. With a diligent filing and limited overlap, the
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`Fintiv factors favor institution.
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`I. Fintiv Factors 2-4 and 6 Strongly Favor Institution
`A. The FWD could precede the ITC target date (Factor 2)
`The ITC’s target date is 10/26/2022 (Ex. 2006, p. 5), which is ~7 weeks
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`before the latest possible FWD date (12/15/2022). Thus, the FWD could precede
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`the ITC’s target date, assuming the ID and FWD issue before statutory deadlines,
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`which is common. The ITC also confirmed that “dates…for the scheduled
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`hearings…are subject to change because of restrictions and uncertainty due to the
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`COVID-19 pandemic,” Ex. 2006, p. 2, providing evidence that the ITC schedule
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`may slip and making it more likely that the FWD precedes ITC resolution.
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`To aid in the ability of the FWD to precede the ITC’s target date, Apple
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`requests its typical 3-month period for the Petitioner Reply be shortened by up to 7
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`weeks. With this adjustment in schedule, the FWD date would be able to precede
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`1
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`the ITC’s target date, and factor 2 weighs in favor of institution.
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`At worst, factor 2 is neutral because the Board considers the proximity of the
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`parallel proceeding to the FWD. When the FWD is due shortly after the target
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`date—here, at worst, ~7 weeks later—this factor receives little weight. Sotera
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`Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 at 15 (2020). Also, as
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`discussed for factor 4, “given the minimal, if any, overlap between the issues in the
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`ITC investigation and this proceeding, the time overlap has less significance.”
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`SharkNinja v. iRobot Corp., IPR2021-00545, Paper 11 at 7 (2021).
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`B.
`Petitioner’s diligence favors institution (Factor 3)
`AliveCor’s argument that Apple’s diligence should not affect the Board’s
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`analysis is contradicted by Fintiv, which states that “evidence show[ing] that the
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`petitioner filed the petition expeditiously, … weigh[s] against exercising
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`[discretion].” Apple v. Fintiv, IPR2020-00019, Paper 11 at 11 (2020).
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`Apple filed the Petition on 6/9/2021, less than three weeks after the ITC
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`instituted the investigation (5/20/2021) and before filing its response to the ITC
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`Complaint (6/28/2021). Ex. 2007. With this diligence, the investment in the ITC
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`proceeding “is not a result of Petitioner’s delay” and significant events (e.g., expert
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`reports, summary determination motions, pre-trial briefs, hearing, etc.) remain in
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`the ITC case post-institution. SharkNinja, IPR2021-00545, Paper 11 at 7-8.
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`Moreover, Apple’s filing is unquestionably diligent relative to AliveCor’s
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`2
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`Texas case. Nothing of substance has occurred in the Texas case because it was
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`stayed in favor of the ITC case before Apple’s deadline to answer. Thus, minimal
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`investment has occurred in Texas and this IPR will resolve long before the Texas
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`case resumes. By filing shortly after ITC institution and before responding to either
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`AliveCor complaint, Apple’s filing was diligent and Factor 3 weighs strongly in
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`favor of institution. Ocado v. Autostore, IPR2021-00311, Paper 11 at 14-15 (“We
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`credit Petitioner’s diligence in filing…just over one month after [ITC] institution”).
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`C.
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`Petitioner’s stipulation and omission of IPR prior art from its ITC
`contentions strongly favors institution (Factor 4)
`Apple’s broad stipulation prevents overlap because it requires the prior art
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`addressed in each forum to be mutually exclusive, thereby obviating the possibility
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`of inconsistent results. In fact, Apple has not advanced the IPR prior art in the ITC
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`at all, making clear in its invalidity contentions that “Apple is not relying on the
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`art cited in its petitions at this time given Apple’s stipulation not to do so” and
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`only “intends to rely on such art in the future in the event that the PTAB denies
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`institution.” Ex. 2004, p. 3. With institution, the IPR prior art will never enter the
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`ITC case and there will be no overlap between the ITC prior art and the PTAB
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`prior art. Indeed, AliveCor makes no allegations that IPR prior art references have
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`the same or similar disclosure as different prior art references at issue in the ITC.
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`In effect, Apple’s broad stipulation is similar to a Sotera-type stipulation
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`because it ensures that the limited set of 102/103 grounds advanced at the ITC will
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`3
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`
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`be different than the limited set of 103 grounds advanced in this IPR. Certainly, a
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`Sotera-type stipulation would not prevent consideration of 102/103 grounds in the
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`ITC. Rather, as previously explained by the Board, a Sotera-type stipulation is
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`similar to advancement of grounds that rely on non-printed publication prior art “as
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`the primary references and [that rely] on patents or printed publications only as
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`secondary references.” Philip Morris v. RAI, IPR2020-01094, Paper 9 at 22-23
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`(2021). Accordingly, a Sotera-type stipulation does not prevent consideration of all
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`patent or printed publication prior art and, in fact, does not necessarily foreclose
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`overlap in secondary references between the parallel proceedings. With this
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`background, in some ways, Apple’s stipulation is broader than Sotera because it
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`extinguishes the possibility of any overlap in prior art between the ITC and PTAB.
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`Moreover, events in the litigation remain that will further narrow the overlap
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`between this IPR and the ITC case. Specifically, on November 12, AliveCor must
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`“reduce the number of asserted claims.” Ex. 2006, p. 4. Because the petition
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`challenges all claims, AliveCor will be forced to drop claims from the ITC that are
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`challenged in this proceeding. Further, Apple’s final invalidity contentions are due
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`on November 24, before the institution decision here. Thus, from a practical
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`perspective, there can be no overlap as Apple will need to finalize its ITC prior art
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`before institution. Once claims are dropped and final invalidity contentions served
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`as required, the overlap between this IPR and the ITC case will reduce further.
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`4
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`Given that the ITC case will involve no overlap in prior art and only a subset of
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`the challenged claims, Factor 4 strongly favors institution.
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`D.
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`Patent Owner’s antitrust action and construction arguments are
`inapt while the merits favor institution (Factor 6)
`AliveCor’s reference to its irrelevant antitrust case reinforces the weakness
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`of its arguments – the issues in this IPR are just not present in the antitrust case.
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`Moreover, Apple’s claim constructions advanced in the ITC are consistent with
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`this IPR. See generally Ex. 1056 (consistent positions taken throughout). Indeed,
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`the prior art analysis set forth in the petition clearly indicates prior art disclosure of
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`the constructions proposed at the ITC, making resolution of those constructions
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`unnecessary here. Finally, the ITC does not have authority to invalidate patent
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`claims in a manner that is binding upon the Board or district courts. For these
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`reasons, and based on strong merits, Factor 6 favors institution.
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`II. Fintiv Factors 1 and 5 Are Neutral
`Factors 1 and 5 are, at worst, neutral. Indeed, Apple intends to move for a
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`stay at the ITC upon institution and the Board should decline to speculate on how
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`the ALJ will respond to a stay motion based on IPR institution so early in the ITC
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`case. Ocado v. Autostore, IPR2021-00311, Paper 11 at 11 (“we decline to
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`speculate as to whether the ITC would stay the ITC investigation”).
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`For the reasons set forth above and in the petition, a holistic view of the
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`Fintiv factors supports institution.
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`5
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`
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`Dated: October 25, 2021
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`Respectfully submitted,
`
`/Jeremy J. Monaldo/
`W. Karl Renner, Reg. No. 41,265
`Jeremy Monaldo, Reg. No. 58,680
`Fish & Richardson P.C.
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`T: 202-783-5070
`F: 877-769-7945
`
`Attorneys for Petitioner
`
`
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 CFR § 42.8(b), the undersigned certifies that on October 25,
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`2021, a complete and entire copy of this Petitioner’s Reply and Accompanying
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`Exhibit were provided via email to the Patent Owner by serving the
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`correspondence email addresses of record as follows:
`
`James M. Glass, Registration No. 46,729
`Quinn Emanuel Urquhart & Sullivan LLP
`51 Madison Ave, 22nd Floor
`New York, New York, 10010
`Email: jimglass@quinnemanuel.com
`qe-alivecor@quinnemanuel.com
`
`
`
`Andrew M. Holmes, Registration No. 64,718
`John W. McCauley, Registration No. 63,161
`Quinn Emanuel Urquhart & Sullivan LLP
`50 California St, 22nd Floor
`San Francisco, CA 94111
`Email: drewholmes@quinnemanuel.com
`Email: johnmccauley@quinnemanuel.com
`
`/Crena Pacheco/
`Crena Pacheco
`Fish & Richardson P.C.
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`(617) 596-5938
`
`