IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Gopalakrishnan
`In re Patent of:
`9,572,499 Attorney Docket No.: 50095-0032IP1
`U.S. Patent No.:
`February 21, 2017
`
`Issue Date:
`Appl. Serial No.: 14/730,122
`
`Filing Date:
`June 3, 2015
`
`Title:
`METHODS AND SYSTEMS FOR ARRHYTHMIA TRACKING
`AND SCORING
`
`
`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. 9,572,499 PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`REQUIREMENTS .......................................................................................... 1 
`A.  Grounds for Standing ................................................................................ 1 
`B.  Challenge and Relief Requested ............................................................... 1 
`C.  Priority Date .............................................................................................. 2 
`TECHNOLOGY OVERVIEW AND THE ’499 PATENT ............................ 6 
`A.  ’499 Patent ................................................................................................ 6 
`B.  Prosecution History ................................................................................... 7 
`C.  Level of Ordinary Skill ............................................................................. 8 
`III.  THE CHALLENGED CLAIMS ARE UNPATENTABLE ............................ 8 
`A.  [GROUND 1] – Shmueli and Osorio Render Claims 1-6, 10-16 and 20
`Obvious ..................................................................................................... 8 
`1. 
`Shmueli Overview ........................................................................... 8 
`2.  Osorio Overview ........................................................................... 13 
`3. 
`The Shmueli-Osorio Combination ................................................ 17 
`4. 
`Claim 1 .......................................................................................... 28 
`5. 
`Claim 2 .......................................................................................... 46 
`6. 
`Claim 3 .......................................................................................... 48 
`7. 
`Claim 4 .......................................................................................... 49 
`8. 
`Claim 5 .......................................................................................... 50 
`9. 
`Claim 6 .......................................................................................... 52 
`10.  Claim 10 ........................................................................................ 58 
`11.  Claim 11 ........................................................................................ 61 
`12.  Claim 12 ........................................................................................ 67 
`13.  Claim 13 ........................................................................................ 67 
`14.  Claim 14 ........................................................................................ 67 
`15.  Claim 15 ........................................................................................ 68 
`16.  Claim 16 ........................................................................................ 68 
`17.  Claim 20 ........................................................................................ 68 
`B.  [GROUND 2] – Shmueli in View of Osorio and Hu-1997 Render
`Claims 7-9 and 17-19 Obvious ............................................................... 68 
`1.  Hu-1997 Overview ........................................................................ 68 
`2. 
`The Shmueli-Osorio-Hu-1997 Combination................................. 68 
`3. 
`Claim 7 .......................................................................................... 71 
`4. 
`Claim 8 .......................................................................................... 72 
`5. 
`Claim 9 .......................................................................................... 74 
`6. 
`Claim 17 ........................................................................................ 76 
`7. 
`Claim 18 ........................................................................................ 77 
`
`i
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`8. 
`Claim 19 ........................................................................................ 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
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`
`EXHIBITS
`
`APPLE-1001
`
`U.S. Patent No. 9,572,499 to Gopalakrishnan (“the ’499
`patent”)
`
`APPLE-1002
`
`Excerpts from the Prosecution History of the ’499 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
`
`iii
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`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
`
`iv
`
`

`

`APPLE-1022
`
`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
` 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”)
`
`v
`
`

`

`APPLE-1035
`
`APPLE-1036
`
`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
` 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”)
`
`vi
`
`

`

`APPLE-1043
`
`APPLE-1044
`
`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
` 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
`
`
`
`vii
`
`

`

`APPLE-1053
`
`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
` 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
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`Petitioner (“Apple”) petitions for Inter Partes Review of claims 1-20
`
`(“Challenged Claims”) of U.S. Patent No. 9,572,499 (“’499 patent”).
`
`I.
`
`REQUIREMENTS
`A. Grounds for Standing
`Apple certifies that the ’499 patent is available for IPR. This petition is
`
`being filed within one year of service of a complaint against Apple by Patent
`
`Owner (“AliveCor”). Apple is not barred or estopped from requesting this review
`
`of the Challenged Claims.
`
`B. Challenge and Relief Requested
`Apple requests IPR and cancellation of the Challenged Claims on the
`
`grounds below. In support, this Petition includes a declaration from Dr. Bernard
`
`Chaitman (APPLE-1003).
`
`Ground
`1
`2
`
`Claims
`1-6, 10-16, and 20
`7-9 and 17-19
`
`Basis
`§103: Shmueli in view of Osorio
`§103: Shmueli in view of Osorio and
`Hu-1997
`
`Applied references are prior art on the bases below:
`
`Reference
`Shmueli
`Osorio
`
`Hu-1997
`
`Date(s)
`10/18/2012
`3/13/2014
`3/15/2013
`September
`
`Basis
`§102(a)(1)
`§102(a)(2)
`
`§102(a)(1)
`
`1
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`Basis
`
`Reference
`
`Date(s)
`19971
`
`
`
`C.
`Priority Date
`The ’499 patent is a continuation of an application filed on December 12,
`
`2014, and claims priority to Provisional Application Nos. 61/915,113, filed on
`
`December 12, 2013, 61/953,616, filed on March 14, 2014, 61/969,019, filed March
`
`21, 2014, 61/970,551, filed on March 26, 2014, and 62/014,516, filed on June 19,
`
`2014. The claims of the ’499 patent are not entitled to the priority dates of these
`
`provisional applications because none of them disclose the following limitations of
`
`claims 1 and 11: (1) “determining, using said mobile computing device, a heart rate
`
`variability of said first user based on said heart rate of said first user;” and (2)
`
`“comparing, using said mobile computing device, said heart rate variability of said
`
`first user to said activity level of said first user.” Thus, the earliest priority date to
`
`which the ’499 patent is entitled is December 12, 2014 (“Critical Date”).
`
`Each prior art reference applied in this petition predates the Critical Date of
`
`the ’499 patent. Specifically, Shmueli was published on October 18, 2012 and Hu-
`
`1997 was published in September 1997. Thus, Shmueli and Hu-1997 qualify as
`
`prior art under 35 U.S.C. §102(a)(1) even if AliveCor attempts to rely upon the
`
`
`1 APPLE-1052, ¶¶ 58-61(authenticating public availability date).
`
`2
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`priority date of Provisional Application No. 61/915,113, filed on December 12,
`
`2013 (“Earliest Provisional Application”).
`
`Osorio is a published US patent application that was filed on March 13,
`
`2014, which is prior to the December 12, 2014 priority date of the ’499 patent.
`
`Thus, Osorio qualifies as prior art under 35 U.S.C. §102(a)(2).
`
`As discussed below, even assuming the ’499 patent is entitled to the
`
`December 12, 2013 filing date of its Earliest Provisional Application (it is not as
`
`discussed above), Osorio remains prior art under 35 U.S.C. §102(a)(2) based on
`
`the filing date of its own provisional application.
`
`a. Dynamic Drinkware Analysis
`Osorio claims priority to Provisional Application No. 61/794,540 (“Osorio
`
`Provisional”), filed on March 15, 2013. APPLE-1005, Cover. Osorio Provisional is
`
`incorporated in its entirety in Osorio. APPLE-1005, [0001]. Osorio and Osorio
`
`Provisional share a similar specification and similar claims. See APPLE-1005,
`
`[0003]-[0008], claim 1; APPLE-1010, [0002]-[0006], claims 1 and 2. Osorio is en-
`
`titled to Osorio Provisional’s March 15, 2013 filing date because the Osorio Provi-
`
`sional includes the relevant prior art disclosure and supports at least one of
`
`Osorio’s claims (claim 1) as shown below. See Dynamic Drinkware v. National
`
`Graphics, 800 F.3d 1375 (Fed. Cir. 2015). Claim 1 of Osorio recites:
`
`3
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`(a) A method for detecting a pathological body
`state of a patient, comprising:
`Osorio Provisional discloses “a method of detecting an occurrence of a
`
`pathological state of a patient from body data of said patient, comprising.” APPLE-
`
`1010, claim 1, [0002]-[0004]; [0042]-[0054].
`
`receiving a first body signal of the patient;
`(b)
`Osorio Provisional discloses “receiving a body signal of said patient.” AP-
`
`PLE-1010, claim 1, [0002]-[0004]; [0043].
`
`(c)
`
`determining a first body data variability (BDV)
`from said first body signal;
`Osorio Provisional discloses “determining a current body data variability
`
`(BDV) value based upon said body signal.” APPLE-1010, claim 1, [0002]-[0004];
`
`[0044]; [0053].
`
`determining an activity level of said patient;
`(d)
`Osorio Provisional discloses “determining an activity level of said patient.”
`
`APPLE-1010, claim 1, [0002]-[0003]; [0045]; [0025].
`
`(e)
`
`determining a non-pathological range for said
`first BDV, based at least in part on said activity
`level;
`Osorio Provisional discloses “determining a non-pathological BDV range
`
`based at least in part on said activity level.” APPLE-1010, claim 1, [0002]-[0003];
`
`[0046].
`
`4
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`comparing said first BDV to said non-pathologi-
`cal range for said first BDV;
`Osorio Provisional discloses “comparing said current BDV value to said
`
`(f)
`
`non-pathological BDV range.” APPLE-1010, claim 1, [0002]-[0004]; [0049].
`
`(g)
`
`detecting a pathological body state when said
`first BDV is outside said non-pathological
`range; and
`Osorio Provisional discloses “detecting the occurrence of a pathological
`
`state in response to said current BDV value being outside said non-pathological
`
`BDV range.” APPLE-1010, claim 1, [0002]-[0004]; [0049].
`
`(h)
`
`performing, in response to detecting said patho-
`logical state, at least one further action selected
`from issuing a notice of said detecting, deliver-
`ing a therapy, issuing a warning, determining a
`severity of said pathological state, logging a
`time of occurrence of said detecting, logging a
`response to a therapy, and logging said severity
`of said pathological state.
`Osorio Provisional discloses “performing a further action in response to said
`
`detecting, wherein said further action is selected from confirming said detection of
`
`the occurrence of said pathological state; issuing a warning, delivering a therapy,
`
`determining a severity of said pathological state, or logging to memory one of the
`
`date and time of occurrence of said pathological state, a severity of the pathologi-
`
`cal state, and an effect of a therapy delivered to treat the pathological state.” AP-
`
`PLE-1010, claim 2, [0051].
`
`5
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`II. TECHNOLOGY OVERVIEW AND THE ’499 PATENT
`In his declaration, Dr. Chaitman provides an overview of cardiac monitoring
`
`technology relevant to the ’499 patent. APPLE-1003, ¶¶26-38.
`
`A.
`’499 Patent
`The ’499 patent relates to determining arrhythmia using activity, PPG, and
`
`ECG sensors. APPLE-1001, Abstract, claim 1; APPLE-1003, ¶¶39-40. The ’499
`
`patent claims a method that includes: (1) sensing a heart rate with a heart rate
`
`sensor; (2) determining a heart rate variability (“HRV”) based on the heart rate; (3)
`
`sensing an activity level with a motion sensor; (4) comparing the HRV to the
`
`activity level; and (5) alerting the user to sense an electrocardiogram (“ECG”) in
`
`response to an irregular HRV. Id., claim 1. The ’499 patent explains that the heart
`
`rate can be detected by using photoplethysmography. APPLE-1001, 8:41-45. The
`
`’499 patent further explains that an advisory condition for recording an ECG may
`
`occur due to large continuing fluctuations in heart rate, or when a measured heart
`
`rate increases rapidly without a corresponding increase in activity level. APPLE-
`
`1001, 25:17-22.
`
`As shown below, Figure 10 depicts an example where the heart rate is
`
`detected using a heart rate monitor 1010, an irregularity is detected, and an alert is
`
`provided for the user to record an ECG. APPLE-1001, 23:14-26.
`
`6
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`
`
`
`APPLE-1001, Fig. 10 (annotated)
`
`B.
`Prosecution History
`During prosecution, Applicant amended the claims and argued that the prior
`
`art did not disclose added features of “a motion sensor, sensing an activity level
`
`of a user, and comparing an activity level of the user to an HRV value of the
`
`user.” APPLE-1002, 342-347. Applicant also distinguished prior art by arguing
`
`that the claimed “heart rate sensor” is different from the ECG sensor in the prior
`
`art. APPLE-1002, 342-347.
`
`During prosecution, the examiner did not consider Shmueli, which teaches
`
`the original claim limitations alleged to be missing from the prior art. APPLE-
`
`1002. Neither did the examiner consider Osorio, which teaches the added features
`
`7
`
`

`

`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
`alleged to be missing from the prior art. Id. The examiner also did not consider
`
`Hu-1997. Id.
`
`C. Level of Ordinary Skill
`A person of ordinary skill in the art in this matter (“POSITA”) would have
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`had at least a combination of Bachelor’s Degree (or a similar Master’s Degree, or
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`higher degree) in an academic area emphasizing health science, or a related field,
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`and two or more years of work experience with cardiac monitoring technologies
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`(e.g., as a cardiologist). APPLE-1003, ¶¶10-11. Additional education or industry
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`experience may compensate for a deficit in one of the other aspects of the
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`requirements stated above. Id.
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`III. THE CHALLENGED CLAIMS ARE UNPATENTABLE2
`A.
`[GROUND 1] – Shmueli and Osorio Render Claims 1-6, 10-
`16, and 20 Obvious
`1.
`Shmueli Overview
`(a) Monitoring Device
`Shmueli is titled “Pulse oximetry measurement triggering ECG
`
`measurement.” APPLE-1004, Cover. Shmueli’s heart monitoring device includes
`
`
`2 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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`Attorney Docket No. 50095-0032IP1
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`an “oximetry measuring unit” for measuring oxygen saturation (SpO2), which
`
`Shmueli describes as being the same as PPG. APPLE-1004, 7:25-27. The heart
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`monitoring device also includes an “ECG measuring unit” with electrical contacts
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`for measuring ECG, and a “processor” to control both types of measurements.
`
`APPLE-1004, 4:1-9, 9:8-16, 11:10-21; APPLE-1003, ¶45.
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`Shmueli’s heart monitoring device has a wrist-mounted form factor. See
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`APPLE-1004, FIGS. 1A, 1B, 2-5; APPLE-1003, ¶46.
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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, ¶47.
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`Attorney Docket No. 50095-0032IP1
`IPR of U.S. Patent No. 9,572,499
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`APPLE-1004, Fig. 3 (annotated)
`
`
`
`(b) Monitoring Technique
`Shmueli’s heart monitoring device performs a monitoring technique that
`
`involves “continuously measuring [oxygen saturation (SpO2)] at the wrist of the
`
`user, detecting an irregular heart condition from the SpO2 measurement,
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`notifying the user to perform an ECG measurement, and initiating the ECG
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`measurement at least partially at the wrist.” APPLE-1004, Abstract (emphasis
`
`added).
`
`As Dr. Chaitman explains, a POSITA would have understood that the term
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`“irregular heart condition” refers to arrhythmia for several reasons. APPLE-1003,
`
`¶49. First, Shmueli’s disclosure supports this understanding since Shmueli
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`discloses both detecting the “irregular heart condition” based on PPG data and
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`Attorney Docket No. 50095-0032IP1
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`confirming the diagnosis with an ECG measurement. APPLE-1004, Abstract, FIG.
`
`8; 8:23-28; APPLE-1003, ¶49. Although “irregular heart condition” is not a
`
`standard term in medicine, a POSITA would have understood that this term refers
`
`to arrhythmia, which is one of the most obvious (if not the most obvious) types of
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`“irregular heart condition[s]” that can be determined using PPG and ECG data.
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`APPLE-1016, p.6081; APPLE-1020, Abstract, 44:29-32; APPLE-1011, Abstract;
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`APPLE-1003, ¶49. Indeed, the Merriam-Webster Dictionary defines “heart
`
`disease” as “an abnormal condition of the heart or of the heart and circulation
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`(such as coronary heart disease, arrhythmia, or heart-valve defect).” APPLE-
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`1023, 2. Similarly, the Black Medical Dictionary lists “arrhythmia” as the first
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`condition under the heading “Heart, Disease of.” APPLE-1047, 320-321.
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`Likewise, the ’499 patent describes arrhythmia as “a cardiac condition in which
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`the electrical activity of the heart is irregular. . .” APPLE-1001, 1:31-33. Shmueli
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`also recognizes that “[d]eriving heart rate from oximetry” was known in the art and
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`was commonly understood to be used in detection of arrhythmias. APPLE-1004,
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`8:11-13; APPLE-1003, ¶49. Shmueli also offers an expansive definition of the
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`term “irregular heart condition.” APPLE-1004, 15:3-5.
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`Like the ’499 patent, Shmueli’s heart monitoring device detects arrhythmia
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`using PPG. APPLE-1004, Abstract, APPLE-1003, ¶50. Shmueli’s Figure 7
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`provides an example of its cardiac monitoring technique.
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`Attorney Docket No. 50095-0032IP1
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`APPLE-1004, Fig. 7 (annotated)
`
`
`
`As shown above, Shmueli’s heart monitoring device uses PPG data to detect
`
`an irregular heart condition (arrhythmia) at elements 37-38. APPLE-1004, 12:9-
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`22. If arrhythmia is detected at element 40, the heart monitoring device triggers an
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`ECG measurement at element 41 by providing a notification to the user to take the
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`ECG measurement at element 42. Id., 12:23-32; ¶51.
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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; APPLE-1003, ¶52. This is because Shmueli criticizes other heart
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`monitoring devices for “not consider[ing] a requirement to enable a patient to
`
`perform ECG measurement as soon as an irregular heart activity develops and
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`without requiring the ECG to be constantly wired to the patient.” Id., 8:21-24. A
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`POSITA would have recognized that Shmueli’s focus on enabling ECG
`
`measurements “as soon as” an irregular heart condition is detected enables ECG
`
`data to be used to confirm the detection of the irregular heart condition using PPG
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`data, thereby improving detection accuracy compared to prior art heart monitoring
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`devices. See APPLE-1004, 13:16-21 (describing that developing correlations
`
`between PPG data and ECG data provides the ability to “produce new detection
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`parameters, or modify existing detection parameters, so as to enhance the detection
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`algorithms of the irregular heart conditions”); APPLE-1003, ¶52.
`
`2. Osorio Overview
`Osorio is titled “Pathological state detection using dynamically determined
`
`body data variability range values.” APPLE-1005, Cover. Osorio’s monitoring
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`technique includes receiving a body signal of the patient and determining a body
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`data variability (BDV) from the body signal. Id., Abstract, [0003]; APPLE-1010,
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`[002]. Osorio describes the body signal as heart rate (“HR”) and the BDV as heart
`
`rate variability (“HRV”). APPLE-1005, [0042]-[0043], [0080]; APPLE-1010,
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`[003], [0035]. Osorio’s monitoring technique also includes determining an activity
`
`level of a patient based on data from an activity sensor (e.g., accelerometer).
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`APPLE-1005, [0035]; APPLE-1010, [0025]-[0026]. Osorio describes detecting a
`
`pathological state (e.g., arrhythmia) by comparing the current BDV value to a
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`BDV non-pathological range that is determined based on the activity level.
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`APPLE-1005, [0003]; APPLE-1010, [0046]-[0049]; APPLE-1003, ¶53. Figure 8
`
`shows an example of Osorio’s monitoring technique:
`
`APPLE-1005, Fig. 8 (annotated)
`
`
`
`As shown above, an activity level is determined at 810, and a non-
`
`pathological BDV range is determined at 820 based on the activity level. APPLE-
`
`1005, [0077]; APPLE-1010, [0045]-[0046]. A current BDV is determined at 840
`
`and compared to the non-pathological BDV range at 850. APPLE-1005, [0078];
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`APPLE-1010, [0049]. If the current BDV is outside the non-pathological range,
`
`then a pathological state is determined at 860. Id. Thereafter, a further action,
`
`such as warning, treating, or logging the occurrence and/or severity of the
`
`pathological state, is taken at 870. APPLE-1005, [0078]; APPLE-1010, [0051];
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`APPLE-1003, ¶54.
`
`Osorio’s detection of a pathological state encompasses detecting arrhythmia.
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`APPLE-1005, [0046] (discussing detecting “a tachycardia episode”); [0071]
`
`(discussing detecting “the emergence of one or more cardiac arrhythmias”). A
`
`POSITA would have therefore understood and/or found obvious that Osorio’s
`
`detection of a pathological state involves detecting an arrhythmia. APPLE-1003,
`
`¶55.
`
`Osorio explains that accurate detection of a pathological condition (e.g.,
`
`arrhythmia) based on a patient’s HR should also consider the patient’s activity
`
`level. APPLE-1005, [0029]; APPLE-1010, [0038], [0041]-[0050]; APPLE-1003,
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`¶56. Osorio recognizes that both HR and activity level affect the non-pathological
`
`BDV range and, thus, affect the detection of a pathological condition (e.g.,
`
`arrhythmia) using the non-pathological BDV range. APPLE-1005, [0058];
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`APPLE-1010, [0038], [0041]-[0050].
`
`Osorio’s Figure 4A (below) shows the dynamic relationship between HR,
`
`HRV, and activity level. APPLE-1003, ¶58; APPLE-1010, Fig. 4.
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`Attorney Docket No. 50095-0032IP1
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`
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`APPLE-1005, Figs. 4A (annotated)
`
`As shown, a patient’s activity level is shown on the x-axis and the patient’s
`
`HR is shown on the y-axis. APPLE-1005, [0057]; APPLE-1010, [0038]. HRV is
`
`represented by bars R1-R4. Id. Non-pathological HRV ranges are illustrated in
`
`green and pathological HRV values are il