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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,
`
`v.
`
`ALIVECOR, INC.,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2021-00972
`Patent 10,638,941
`
`
`
`
`
`
`
`
`
`PETITIONER’S REPLY TO
`PATENT OWNER’S PRELIMINARY RESPONSE
`
`
`
`APPLE-1001
`
`APPLE-1002
`
`
`EXHIBIT LIST
`U.S. Patent 10,638,941 to Albert et al. (“the ’941 patent”)
`
`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
`ii
`
`
`
`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”)
`
`APPLE-1022
`
` Frits L. Meijler and Fred H. M. Wittkampf, “Role of the
`iii
`
`
`
`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”)
`
`APPLE-1035
`
` Karvonen, J., Vuorimaa, T. Heart Rate and Exercise Intensity
`
`iv
`
`
`
`During Sports Activities. Sports Medicine 5, 303–311 (1988)
`(“Karvonen-1988”)
`
`APPLE-1036
`
` 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”)
`
`APPLE-1042
`
` Sajda P. Machine learning for detection and diagnosis of
`disease. Annu Rev Biomed Eng. 2006; 8:537-65 (“Sajda-
`2006”)
`
`v
`
`
`
`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
`
`APPLE-1052
`
`Declaration of Mr. Jacob Munford
`
`APPLE-1053
`
`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)
`vi
`
`
`
`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
`
`vii
`
`
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`Apple’s diligence and strong stipulation favor institution. Specifically,
`
`Apple’s diligent filing of its Petition before responding to the ITC Complaint
`
`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
`
`Fintiv factors favor institution.
`
`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
`
`before the latest possible FWD date (12/15/2022). Thus, the FWD could precede
`
`the ITC’s target date, assuming the ID and FWD issue before statutory deadlines,
`
`which is common. The ITC also confirmed that “dates…for the scheduled
`
`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
`
`may slip and making it more likely that the FWD precedes ITC resolution.
`
`To aid in the ability of the FWD to precede the ITC’s target date, Apple
`
`requests its typical 3-month period for the Petitioner Reply be shortened by up to 7
`
`weeks. With this adjustment in schedule, the FWD date would be able to precede
`
`1
`
`
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`the ITC’s target date, and factor 2 weighs in favor of institution.
`
`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
`
`discussed for factor 4, “given the minimal, if any, overlap between the issues in the
`
`ITC investigation and this proceeding, the time overlap has less significance.”
`
`SharkNinja v. iRobot Corp., IPR2021-00545, Paper 11 at 7 (2021).
`
`B.
`Petitioner’s diligence favors institution (Factor 3)
`AliveCor’s argument that Apple’s diligence should not affect the Board’s
`
`analysis is contradicted by Fintiv, which states that “evidence show[ing] that the
`
`petitioner filed the petition expeditiously, … weigh[s] against exercising
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`[discretion].” Apple v. Fintiv, IPR2020-00019, Paper 11 at 11 (2020).
`
`Apple filed the Petition on 6/9/2021, less than three weeks after the ITC
`
`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
`
`proceeding “is not a result of Petitioner’s delay” and significant events (e.g., expert
`
`reports, summary determination motions, pre-trial briefs, hearing, etc.) remain in
`
`the ITC case post-institution. SharkNinja, IPR2021-00545, Paper 11 at 7-8.
`
`Moreover, Apple’s filing is unquestionably diligent relative to AliveCor’s
`
`2
`
`
`
`Texas case. Nothing of substance has occurred in the Texas case because it was
`
`stayed in favor of the ITC case before Apple’s deadline to answer. Thus, minimal
`
`investment has occurred in Texas and this IPR will resolve long before the Texas
`
`case resumes. By filing shortly after ITC institution and before responding to either
`
`AliveCor complaint, Apple’s filing was diligent and Factor 3 weighs strongly in
`
`favor of institution. Ocado v. Autostore, IPR2021-00311, Paper 11 at 14-15 (“We
`
`credit Petitioner’s diligence in filing…just over one month after [ITC] institution”).
`
`C.
`
`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
`
`addressed in each forum to be mutually exclusive, thereby obviating the possibility
`
`of inconsistent results. In fact, Apple has not advanced the IPR prior art in the ITC
`
`at all, making clear in its invalidity contentions that “Apple is not relying on the
`
`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
`
`prior art. Indeed, AliveCor makes no allegations that IPR prior art references have
`
`the same or similar disclosure as different prior art references at issue in the ITC.
`
`In effect, Apple’s broad stipulation is similar to a Sotera-type stipulation
`
`because it ensures that the limited set of 102/103 grounds advanced at the ITC will
`
`3
`
`
`
`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
`
`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
`
`(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
`
`extinguishes the possibility of any overlap in prior art between the ITC and PTAB.
`
`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
`
`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
`
`perspective, there can be no overlap as Apple will need to finalize its ITC prior art
`
`before institution. Once claims are dropped and final invalidity contentions served
`
`as required, the overlap between this IPR and the ITC case will reduce further.
`
`4
`
`
`
`Given that the ITC case will involve no overlap in prior art and only a subset of
`
`the challenged claims, Factor 4 strongly favors institution.
`
`D.
`
`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
`
`of its arguments – the issues in this IPR are just not present in the antitrust case.
`
`Moreover, Apple’s claim constructions advanced in the ITC are consistent with
`
`this IPR. See generally Ex. 1056 (consistent positions taken throughout). Indeed,
`
`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
`
`unnecessary here. Finally, the ITC does not have authority to invalidate patent
`
`claims in a manner that is binding upon the Board or district courts. For these
`
`reasons, and based on strong merits, Factor 6 favors institution.
`
`II. Fintiv Factors 1 and 5 Are Neutral
`Factors 1 and 5 are, at worst, neutral. Indeed, Apple intends to move for a
`
`stay at the ITC upon institution and the Board should decline to speculate on how
`
`the ALJ will respond to a stay motion based on IPR institution so early in the ITC
`
`case. Ocado v. Autostore, IPR2021-00311, Paper 11 at 11 (“we decline to
`
`speculate as to whether the ITC would stay the ITC investigation”).
`
`For the reasons set forth above and in the petition, a holistic view of the
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`Fintiv factors supports institution.
`
`5
`
`
`
`Dated: October 25, 2021
`
`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
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 CFR § 42.8(b), the undersigned certifies that on October 25,
`
`2021, a complete and entire copy of this Petitioner’s Reply and Accompanying
`
`Exhibit were provided via email to the Patent Owner by serving the
`
`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
`
`
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