Trials@uspto.gov
`571-272-7822
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`Paper 43
`Date: December 6, 2022
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APPLE, INC.,
`Petitioner,
`
`v.
`
`ALIVECOR, INC.,
`Patent Owner.
`____________
`
`IPR2021-00972
`Patent 10,638,941 B2
`___________
`
`
`
`
`Before ROBERT A. POLLOCK, ERIC C. JESCHKE, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`Denying In-Part and Dismissing In-Part as Dismissing Patent Owner’s
`Motion to Exclude Evidence as Moot
`37 C.F.R. § 42.64
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 43
`Date: December 6, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APPLE, INC.,
`Petitioner,
`
`v.
`
`ALIVECOR, INC.,
`Patent Owner.
`____________
`
`IPR2021-00972
`Patent 10,638,941 B2
`___________
`
`
`
`
`Before ROBERT A. POLLOCK, ERIC C. JESCHKE, and
`DAVID COTTA, Administrative Patent Judges.
`
`COTTA, Administrative Patent Judge.
`
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`Denying In-Part and Dismissing In-Part as Dismissing Patent Owner’s
`Motion to Exclude Evidence as Moot
`37 C.F.R. § 42.64
`
`
`
`
`
`IPR2021-00972
`Patent 10,638,941 B2
`
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`A. Background
`Apple, Inc. (“Petitioner”) filed a Petition for an inter partes review of
`claims 1–23 of U.S. Patent No. 10,638,941 B2 (Ex. 1001, “the ’941 patent”).
`Paper 2 (“Pet.”). AliveCor, Inc. (“Patent Owner”) timely filed a Preliminary
`Response. Paper 6 (“Prelim. Resp.”). Petitioner further filed an authorized
`Reply to the Preliminary Response (Paper 7); Patent Owner filed a
`responsive Sur-reply (Paper 8). Taking into account the arguments and
`evidence presented, we determined that the information presented in the
`Petition established that there was a reasonable likelihood that Petitioner
`would prevail in demonstrating unpatentability of at least one challenged
`claim of the ’941 patent, and we instituted this inter partes review as to all
`challenged claims. Paper 10 (“DI”).
`After institution, Patent Owner filed a Patent Owner Response (Paper
`27, “PO Resp.”); Petitioner filed a Reply to the Patent Owner Response
`(Paper 29, “Reply”); Patent Owner filed a (corrected) Sur-reply (Paper 35,
`“PO Sur-reply”).
`Patent Owner also filed a motion to exclude (Paper 34, “Mot.”);
`Petitioner opposed the motion (Paper 36, “Opp. Mot.”); and Patent Owner
`filed a reply in support of its motion (Paper 38, “Reply Mot.”).
`An oral hearing was held on September 14, 2022, and a transcript of
`the hearing is included in the record. Paper 41 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6. This decision is a Final
`Written Decision under 35 U.S.C. § 318(a) as to the patentability of claims
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`1–23 of the ’941 patent. For the reasons discussed below, we hold that
`Petitioner has demonstrated by a preponderance of the evidence that claims
`1–23 are unpatentable.
`
`B. Real Parties-in-Interest
`Petitioner identifies itself, Apple Inc., as the real party-in-interest.
`Pet. 84. Patent Owner, identifies itself, AliveCor, Inc., as the real party-in-
`interest. Paper 4, 2.
`
`C. Related Matters
`According to Patent Owner:
`U.S. Patent No. 10,638,941 has been asserted by Patent
`Owner against Petitioner in AliveCor, Inc. v. Apple, Inc., Case
`No. 6:20-cv-01112-ADA, filed in the United States District
`Court for the Western District of Texas, and in Investigation
`No. 337-TA-1266 before the International Trade Commission,
`In the Matter of Certain Wearable Electronic Devices with
`ECG Functionality and Components Thereof. Apple also filed
`IPR petitions against the other patents asserted in those actions:
`IPR2021-00970 (USP 9,572,499) and IPR2021-00971 (USP
`10,595,731).
`Paper 6, 2; see Pet. 84.
`
`D. Asserted Grounds of Unpatentability
`Petitioner asserts the following grounds of unpatentability (Pet. 1):
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`Claim(s) Challenged
`1, 5, 7–9, 11, 12, 16,
`18–20, 22, 23
`2–4, 6, 13–15, 17
`
`10, 21
`
`35 U.S.C. §
`1031
`
`Reference(s)/Basis
`Shmueli,2 Osorio3
`
`103
`
`103
`
`Shmueli, Osorio, Lee-20134
`
`Shmueli, Osorio, Chan5
`
`In support of its patentability challenge, Petitioner relies on, inter alia, the
`Declaration of Dr. Bernard R. Chaitman, M.D. Ex. 1003. Patent Owner
`similarly relies on the Declarations of Dr. Igor Efimov, Ph.D. Exs. 2001 and
`2016.
`
`E. Technological Background
`Electrocardiography measures “the electrical activity of the heart,
`which can be indicative of various heart diseases.” Ex. 1003 ¶ 28 (Chaitman
`Decl.). “In conventional clinical practice, [electrocardiography] and
`telemetry are used at a hospital to diagnose cardiac arrhythmias.” Id.
`¶ 30.
`An electrocardiogram (“ECG”) represents “electrical activity of the
`heart based on depolarization and repolarization of the atria and ventricles,
`which typically show up as five distinct waves on [an] ECG readout –
`
`
`1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Based on the filing
`date of the ’941 patent, we apply the AIA versions of §§ 102 and 103.
`2 Shmueli et al., WO 2012/140559 A1, published Oct. 18, 2012, (Ex. 1004,
`“Shmueli”).
`3 Osorio, U.S. Patent Publication No. 2014/0275840 A1, published Sept. 18,
`2014, (Ex. 1005, “Osorio”).
`4 Jinseok Lee et al., Atrial Fibrillation Detection using a Smart Phone, 15:1
`INT’L. J. OF BIOELECTROMAGNETISM 26–29 (2013) (Ex. 1011, “Lee-2013”).
`5 Chan et al., U.S. Patent No. 7,894,888 B2, issued Feb. 22, 2011 (Ex. 1048,
`“Chan”).
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`P-wave, Q-wave, R-wave, S-wave, and T-wave.” Id. ¶ 29. “An R-R
`interval represents a time elapsed between successive R-waves of a QRS
`complex6 of the ECG that occur between successive heart beats.” Id. “If
`[the] R-R interval durations over a time period are close to one another in
`value, then ventricular rhythm is understood to be ‘regular.’ In contrast, if
`there are significant variations in the R-R interval durations over a time
`period, then the ventricular rhythm is understood to be ‘irregular.’” Id. ¶ 29
`(internal citations omitted).
`“Photoplethysmography (PPG) is a simple noninvasive optical
`technique” that uses a “light source to illuminate subcutaneous tissue and a
`photo detector with spectral characteristics matching those of the light
`source” to “monitor[] beat-to-beat relative blood volume changes in the
`microvascular bed of peripheral tissues.” Id. ¶ 31. According to Dr.
`Chaitman, “the information derived from RR intervals of ECG can also be
`derived from the pulse period of a PPG reading.” Id. ¶ 32. PPG is
`“sometimes . . . referred to as blood oxygen saturation, pulse oximeter,
`oximetry, and SpO2.” Id. ¶ 31.
`Heart rate variability (“HRV”) is defined as “the variation of RR
`intervals with respect to time and reflects beat-to-beat heart rate (HR)
`variability.” Id. ¶ 34. It “can be accurately determined based on either ECG
`data or PPG data.” Id. ¶ 35. With respect to the former, this involves
`measuring RR intervals. Id. ¶ 29. According to Dr. Chaitman, “HRV
`
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`6 “A QRS complex is a combination of the Q, R, and S waves occurring
`in succession and represents the electrical impulse of a heartbeat as it
`spreads through the ventricles during ventricular depolarization.” Ex. 1003
`¶ 29.
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`analysis is an important tool in cardiology to help diagnose various types of
`arrhythmia.” Id. ¶ 34.
`
`F. The ’941 Patent
`The ’941 patent discloses that “[i]rregular heartbeats and arrhythmias
`are associated with significant morbidity and mortality in patients.” Ex.
`1001, 1:17–18. According to the ’941 patent, “[n]on-invasive cardiac
`monitoring is useful in diagnosing cardiac arrhythmia.” Id. at 1:21–22. In
`furtherance of this use, the ’941 patent discloses “systems, devices, and
`methods for cardiac monitoring,” including, for example “portable
`computing devices such as smartphones, smartwatches, laptops, and tablet
`computers.” Id. at 1:26–30.
`The ’941 patent explains that “certain parameter values may be
`conveniently sensed continuously such as, for example, heart rate and
`activity level, and analyzed to predict or determine the presence of an
`arrhythmia.” Id. at 1:58–61. For example, the ’941 patent describes
`analyzing heart rate and activity level and identifying discordance between
`these two parameters to determine the presence or the future onset of an
`arrhythmia. Id. at 1:61–66. If the presence or the future onset of an
`arrhythmia is identified, an electrocardiogram (ECG) may be initiated. Id. at
`2:1–3.
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`Figure 7 of the ’941 patent is reproduced below.
`
`Figure 7 schematically depicts “an algorithm for discordance monitoring.”
`Id. at 3:53–54. The ’941 patent explains that a heart rate and an activity
`level are sensed in step 700. Id. at 14:49–51. The ’941 patent describes
`sensing an activity level with a gyroscope or an accelerometer and sensing
`heart rate using “light based or other commonly used heart rate sensors.” Id.
`at 14:51–54. Figure 7 depicts various possible outcomes from the sensing of
`heart rate and activity level. Id. at Fig. 7, elements 702, 704, 706, 708, 710.
`For example, in step 702, the sensors detect “an increased heart rate . . .
`together with a normal or resting activity level.” Id. at 14:59–60. This result
`is identified as a “discordance [that] may indicate the presence of an
`arrhythmia.” Id. at 14:59–66. “As such, an ECG is caused to be sensed in
`step 712A.” Id. at 14:66–67. Steps 704, 706, 708, and 710 depict other
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`potential outcomes from the sensing of heart rate and activity level as well as
`the actions taken for each potential outcome. Id. at 15:22–58.
`
`G. Challenged Claims
`The ’941 patent includes twenty-three claims. All of those are
`challenged here. Pet. 1. Claims 1 and 12 are the only independent claims.
`Claim 1 is illustrative of the claims challenged in this Petition and reads as
`follows:
`1. A method of cardiac monitoring, comprising:
`sensing an activity level of a user with a first sensor on a
`smartwatch worn by the user;
`when the activity level is resting, sensing a heart rate
`parameter of the user with a second sensor on the smartwatch;
`determining, by a processing device, that a discordance is
`present between the activity level value and the heart rate
`parameter;
`based on the presence of the discordance, indicating to
`the user, using the smartwatch, a possibility of an arrhythmia
`being present; and
`receiving electric signals of the user from an
`electrocardiogram sensor (“ECG”) on the smartwatch to
`confirm a presence of the arrhythmia, wherein the ECG sensor
`comprises a first electrode and a second electrode.
`Ex. 1001, 17:2–18.
`H. Overview of the Asserted References
`1) Shmueli (Exhibit 1004)
`Shmueli, titled “Pulse Oximetry Measurement Triggering ECG
`Measurement,” addresses “solutions . . . for monitoring infrequent events of
`irregular ECG.” Ex. 1004, 2.7 According to Shmueli, “[t]he present
`
`
`7 Throughout this decision, we refer to native pagination wherever it is
`available. For clarity with respect to citations to Shmueli, we understand the
`native pagination to be the numbers at the top of the page.
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`invention preferably performs measurements of intermittent irregular heart-
`related events without requiring the fixed wiring of the ECG device to the
`patient.” Id. at 8.
`Shmueli’s discloses body-worn cardiac monitoring devices “equipped
`with two types of sensing devices: an oximetry (SpO2) measuring unit and
`an ECG measuring unit.” Id. at 9.8 Shmueli’s Figures 1A, 1B, and 3,
`reproduced below, exemplify one embodiment (annotations by Petitioner in
`red):
`
`Pet. 12. Figures 1A, 1B, and 3 show three views of a wrist-mount heart
`monitoring device having three ECG electrodes 14 and a PPG sensor 13.
`Ex. 1004, 6, 9–10. Figure 1A shows two of the ECG electrodes, 14/16, on
`the face of the device. Id. at 9. Figure 1B shows a third ECG electrode,
`14/15, along with PPG sensor 13, of the back of the device. Id. Figure 3
`shows the device as worn on a patient’s wrist, with PPG sensor 13 and ECG
`
`
`8 As used by Shmueli, “the terms ‘oxygen saturation in the blood’, ‘blood
`oxygen saturation’, ‘pulse oximeter’, oximetry, SpO2, and
`photoplethysmography have the same meaning and may be used
`interchangeably, except for those places where a difference between such
`terms is described.” Id. at 7; see Tr. 6:22–7:12, 73:18–21, 95:7–11.
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`electrode 14/15 in contact with the patient’s left wrist and ECG electrodes
`14/16 in contact with two fingers of the patient’s right hand. Id. Petitioner
`annotates each of Figures 1A, 1B, and 3 with arrows identifying the ECG
`electrodes. Pet. 12. Petitioner has also annotated Figure 1B with an arrow
`identifying PPG sensor 13. Id. In connection with these devices, Shmueli
`discloses
`a method for triggering measurement of electrocardiogram
`(ECG) signal of a subject, the method including the steps of:
`continuously measuring SpO2 at least one of a wrist and a
`finger of the subject, detecting an irregular heart condition from
`the SpO2 measurement, notifying the subject to perform an
`ECG measurement, and initiating ECG measurement at least
`partially at the wrist.
`Ex. 1004. at 2; see Abstract.
`Shmueli explains that “[d]eriving heart beat rate from oximetry, as
`well as other artifacts of the heart activity and blood flow, is . . . known in
`the art,” as are various body-worn oximetry devices. Id. at 8. Shmueli
`further explains that the use of oximetry in combination with ECG
`measurements is also known in the art. Id. Shmueli states, for example, that
`“US patent No. 7,598,878 (Goldreich) describes a wrist mounted device
`equipped with an ECG measuring device and a SpO2 measuring device.” Id.
`However, Shmueli, notes “Goldreich does not teach interrelated
`measurements of ECG and SpO2” and, thus, does not “enable a patient to
`perform ECG measurement as soon as an irregular heart activity develops
`and without requiring the ECG to be constantly wired to the patient.” Id.
`According to Shmueli:
`The present invention resolves this problem by providing a
`combined oximetry and electrocardiogram measuring system
`and a method in which the oximetry measurement is performed
`continuously and/or repeatedly, and the ECG measurement is
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`triggered upon detection of an intermittent irregular heart-
`related events without requiring the fixed wiring of the ECG
`device to the patient.
`Id. Consistent with this disclosure, Shmueli’s claims:
`1. A method for triggering measurement of
`electrocardiogram (ECG) signal of a subject, the method
`comprising the steps of:
`continuously measuring SpO2 at least one of a wrist
`and a finger of said subject;
`detecting an irregular heart condition from said SpO2
`measurement;
`notifying said subject to perform an ECG
`measurement; and
`initiating ECG measurement at least partially at said wrist.
`Id. at 16.
`
`Shmueli Figure 7 is reproduced below:
`
`“Fig. 7 is a simplified flow chart of a software program preferably executed
`by the processor of the wrist-mounted heart monitoring device.” Id. at 7; see
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`also id. at 12–13 (further describing the steps of the software program
`illustrated in Figure 7).
`
`2) Osorio (Exhibit 1005)
`Osorio, titled “Pathological State Detection Using Dynamically
`Determined Body Data Variability Range Values,” “relates to medical
`device systems and methods capable of detecting a pathological body state
`of a patient, which may include epileptic seizures, and responding to the
`same.” Ex. 1005 ¶ 2. Although broadly referencing “a pathological body
`state,” Osorio repeatedly exemplifies such conditions in terms of detecting
`epileptic events. See, e.g., id. ¶ 37 (referencing values that may “be
`indicative of a certain pathological state (e.g., epileptic seizure)”), ¶ 46 (“In
`one embodiment, the pathological state is an epileptic event, e.g., an
`epileptic seizure.”), ¶ 56 (“HRV range may be taken as an indication of an
`occurrence of a pathological state, e.g., an epileptic seizure”), ¶ 66 (“The
`dynamic relationship between non-pathological HRVs and activity levels
`may be exploited to detect pathological states such as epileptic seizures”).
`Consistent with the broad disclosure and narrow exemplification in
`the body of its specification, Osorio’s claim 1 is directed to “[a] method for
`detecting a pathological body state of a patient,” whereas claim 7 limits the
`pathological state to an epileptic event. Id. at claim 1, claim 7; also compare
`id. at claim 14, with claim 17 (similarly limiting a pathological state to an
`epileptic event).
`According to Osorio, the disclosed methods, systems, and related
`devices, detect a pathological state of a patient by determining when a body
`data variability value, or “BDV,” is outside of a “value range,” and where
`the threshold levels of that range vary in response to the patient’s physical
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`activity (measured by, e.g., an accelerometer) or mental/emotional state.
`See, e.g., id. at code (57), ¶¶ 3–8, 28, 33, 35. In this respect, Osorio states
`that “false negative and false positive detections of pathological events may
`be reduced by dynamically determining pathological or non-pathological
`ranges for particular body indices based on activity type and level or other
`variables (e.g., environmental conditions).” Id. ¶ 36.
`Osorio’s Figure 1 is reproduced below.
`
`Figure 1 shows a schematic representation of medical device system 100,
`including kinetic sensor(s) 212 and body signal sensor(s) 282 connected to
`medical device 200 by leads 211 and 281, respectively. Id. ¶ 33. “[A]ctivity
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`sensor(s) 212 may each be configured to collect at least one signal from a
`patient relating to an activity level of the patient,” and include, for example,
`an accelerometer, an inclinometer, a gyroscope, or an ergometer. Id. Figure
`1 also shows a current body data variability (BDV) module 265, which may
`“may comprise an O2 saturation variability (O2SV) module 330 configured
`to determine O2SV from O2 saturation data,” and “an HRV module 310
`configured to determine HRV from heart rate data.” Id. ¶¶ 10, 53, Fig. 2C.
`Osorio discloses that “medical device system 100 may be fully or partially
`implanted, or alternatively may be fully external.” Id. ¶ 33.
`Figure 8, reproduced below, shows one embodiment of Osorio’s
`monitoring method.
`
`Figure 8 shows that an activity level is determined at 810, and a non-
`pathological BDV range is determined at 820 based on the activity level. Id.
`¶ 77. A current BDV is determined at 840 and compared to the non-
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`pathological BDV range at 850. Id. ¶ 78. If the current BDV is outside the
`non-pathological range, then a pathological state is determined at 860 and a
`further action, such as warning, treating, or logging the occurrence and/or
`severity of the pathological state, is taken at 870. Id.
`
`According to Osorio, body indices that may be the subject of BDV
`monitoring include:
`heart rhythm variability, a heart rate variability (HRV), a
`respiratory rate variability (RRV), a blood pressure variability
`(BPV), a respiratory rhythm variability, respiratory sinus
`arrhythmia, end tidal CO2 concentration variability, power
`variability at a certain neurological index frequency band (e.g.,
`beta), an EKG morphology variability, a heart rate pattern
`variability, an electrodermal variability (e.g., a skin resistivity
`variability or a skin conductivity variability), a pupillary
`diameter variability, a blood oxygen saturation variability, a
`kinetic activity variability, a cognitive activity variability,
`arterial pH variability, venous pH variability, arterial-venous
`pH difference variability, a lactic acid concentration variability,
`a cortisol level variability, or a catecholamine level variability.
`Id. ¶ 43; see also id. ¶ 42 (similar) ¶¶ 45–46 (monitoring heart rate for
`episodes of tachycardia and bradycardia). “In one embodiment, the severity
`[of a pathological state] may be measured by a magnitude and/or duration of
`a pathological state such as a seizure, a type of autonomic change associated
`with the pathological state (e.g., changes in heart rate, breathing rate, brain
`electrical activity, the emergence of one or more cardiac arrhythmias, etc.).”
`Id. ¶ 71.
`
`With respect to HRV, in particular, Osorio teaches: “By monitoring
`the patient’s activity level, HR, and HRV, it is possible to determine when
`the patient’s HRV falls outside the non-pathological ranges as the patient’s
`activity levels change over time.” Id. ¶ 66. Osorio’s Figure 4A, reproduced
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`below, shows heart rate variability as a function of activity level. See id.
`¶ 58.
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`Figure 4A plots a patient’s heart rate (HR) on the Y-axis and a patient’s
`activity level on the X-axis. Id. at Fig. 4A. Markers A1 though A4
`represent increasing activity from a sleep state (A1) through vigorous
`activity (A4). Id. Boundary lines 410 and 420, respectively, represent the
`upper and lower limits of non-pathological heart rate, and include
`representative ranges R1 through R4. Id. According to Osorio,
`the upper and lower bounds of the non-ictal[9] HR region
`increase as activity level increases (e.g., from a sleep state to a
`resting, awake state) and reach their highest values for
`strenuous exertion. In addition, the width of the non-
`pathological HR ranges narrows as activity levels and heart
`rates increase, which is consistent with the known reduction in
`HRV at high levels of exertion. When the patient is in a non-
`pathological state (e.g., when an epileptic patient is not having a
`
`9 “Ictal” refers to the active, middle stage of a seizure and corresponds with
`intense electrical brain activity. See https://epilepsyfoundation.org.au/
`understanding-epilepsy/seizures/seizure-phases/.
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`seizure), for a particular activity level the patient’s HRV should
`fall within a non-pathological HRV range associated with that
`activity level.
`Id. ¶ 58.
`Osorio further presents Figure 11 as “depict[ing] pathological and
`non-pathological BDV (e.g., HRV) value ranges.” Id. ¶¶ 23, 91. In this
`illustration, Osorio shows that HRV values falling below 0.5 bpm and above
`4 bpm are always pathological when activity level is low (e.g., resting or
`walking), whereas intermediate HRV values (0.5–4 bpm) may be
`pathological when considered in light of the patient’s activity level. Id.
`Osorio further notes that the boundaries between normal and pathological
`may be adjusted based on an individual’s physiology. “For example, in an
`epilepsy patient also suffering from tachycardia, and having base resting
`heart rate of 100-110 bpm, a decline in heart rate to 70 bpm may be
`indicative of a seizure slowing down the heart rate, even though a heart rate
`of 70 bpm is generally ‘normal’ across a typical population.” Id. ¶ 45.
`3) Lee-2013 (Exhibit 1011)
`Lee-2013, titled “Atrial Fibrillation Detection Using a Smart Phone,”
`discloses a study to assess whether “an iPhone 4s can be used to detect atrial
`fibrillation (AF) based on its ability to record a pulsatile PPG signal from a
`fingertip using the built-in camera lens.” Ex. 1011, 26.
`Lee-2013 teaches that atrial fibrillation is the “most common
`sustained arrhythmia,” with “[o]ver 3 million Americans” diagnosed. Id.
`According to Lee-2013, there is a “pressing need to develop methods for
`accurate AF detection and monitoring in order to improve patient care and
`reduce healthcare costs.” Id. In response to this need, the authors of Lee-
`2013 developed “a smartphone application to measure pulsatile time series
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`and then use this data to detect AF real-time.” Id. Lee-2013’s study
`concluded that “AF can be accurately detected from pulsatile signals in the
`fingertip using the camera of an iPhone 4s.” Id. at 29.
`
`4) Chan (Exhibit 1048)
`Chan discloses:
`A wristwatch worn by a user for measuring a three-lead ECG
`[that] includes three electrodes placed separately on the front,
`either side, and back or strap thereof. The wristwatch further
`includes an electrode panel having the electrode on the front or
`either side of the watch, sensing elements, pressure, infrared or
`impedance detectors, and circuits. The electrode panel is
`capable of sensing the contact or press of fingers to trigger the
`ECG measuring. While the electrode in the back-side of the
`watch contacts the hand wearing the watch, the electrode and
`electrode panel on the front or either side of the watch are
`pressed by fingers from the other hand, and the electrode in the
`strap contacts the abdomen or left leg simultaneously. Thus, a
`three-lead ECG can be measured. ECG data can be transmitted
`to a personal or hospital computer by wireless networks or flash
`memory.
`Ex. 1048, Abstract.
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`Patent 10,638,941 B2
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`Chan’s figures 1A and 1B, reproduced below, show an embodiment of
`the disclosed three-lead ECG wristwatch.
`
`Figures 1A and 1B, respectively, show the front and back views of a three-
`lead ECG wristwatch. Id. at 2:21–22. Figure 1A shows ECG electrode 4,
`sensing element 6 (which can detect “pressure, impedance or infrared for
`recognizing the contact or press made by fingers to initiate an ECG
`measurement”), and display 7, which may be an LCD. Id. at 2:44–56.
`Display 7 can display text (e.g., time, heart rate, and, condition (normal vs
`arrhythmia) as well as “graph/animation, for an event reminding 13 and
`ECG waveforms 14.” Id. at 2:56–59; see also id. at 4:56–59 (stating, with
`reference to Figure 7, that “display 57 can show users 59 time, heart rate,
`waveforms and any other information 61, such as activity level and
`temperature, if needed”).
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`Chan Figure 2 is reproduced below.
`
`Figure 2 shows an embodiment of the three-lead ECG watch having a third
`lead 5 on the strap 11. Id. at 2:24–25, 3:1–4.
`Chan Figure 3B is reproduced below.
`
`Figure 3B “demonstrate[s] how to place the wristwatch to make electrodes
`be contacted by both hands.” Id. at 2:26–28, 3:5–22.
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`II. ANALYSIS
`
`A. Legal Standards
`“In an IPR, the petitioner has the burden from the onset to show with
`particularity why the patent it challenges is unpatentable.” Harmonic Inc. v.
`Avid Tech., Inc., 815 F.3d 1356, 1363 (citing 35 U.S.C. § 312(a)(3)
`(requiring inter partes review petitions to identify “with particularity . . . the
`evidence that supports the grounds for the challenge to each claim”)). This
`burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015)
`(discussing the burden of proof in inter partes review).
`In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the
`Supreme Court reaffirmed the framework for determining obviousness set
`forth in Graham v. John Deere Co., 383 U.S. 1 (1966). The KSR Court
`summarized the four factual inquiries set forth in Graham (383 U.S. at 17–
`18) that are applied in determining whether a claim is unpatentable as
`obvious under 35 U.S.C. § 103 as follows: (1) determining the scope and
`content of the prior art; (2) ascertaining the differences between the prior art
`and the claims at issue; (3) resolving the level of ordinary skill in the art; and
`(4) considering objective evidence indicating obviousness or non-
`obviousness, if present. KSR, 550 U.S. at 406.
`“[W]hen a patent ‘simply arranges old elements with each performing
`the same function it had been known to perform’ and yields no more than
`one would expect from such an arrangement, the combination is obvious.”
`Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). But
`in analyzing the obviousness of a combination of prior art elements, it can
`also be important to identify a reason that would have prompted one of skill
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`in the art “to combine . . . known elements in the fashion claimed by the
`patent at issue.” Id. at 418. A precise teaching directed to the specific
`subject matter of a challenged claim is not necessary to establish
`obviousness. Id. Rather, “any need or problem known in the field of
`endeavor at the time of invention and addressed by the patent can provide a
`reason for combining the elements in the manner claimed.” Id. at 420.
`Accordingly, a party that petitions the Board for a determination of
`unpatentability based on obviousness must show that “a skilled artisan
`would have been motivated to combine the teachings of the prior art
`references to achieve the claimed invention, and that the skilled artisan
`would have had a reasonable expectation of success in doing so.” In re
`Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016)
`(quotations and citations omitted). Under the proper inquiry, “obviousness
`cannot be avoided simply by a showing of some degree of unpredictability
`in the art so long as there was a reasonable probability of success.” Pfizer,
`Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).
`
`B. Level of Ordinary Skill in the Art
`In determining the level of skill in the art, we consider the type of
`problems encountered in the art, the prior art solutions to those problems, the
`rapidity with which innovations are made, the sophistication of the
`technology, and the educational level of active workers in the field. See
`Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962
`(Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d
`1005, 1011 (Fed. Cir. 1983).
`Petitioner asserts that a person of ordinary skill in the art would have
`been someone with
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`at least a combination of [a] Bachelor’s Degree (or a similar
`Master’s Degree, or higher degree) in an academic area
`emphasizing health science, or a related field, and two or more
`years of work experience with cardiac monitoring technologies
`(e.g., as a cardiologist).
`Ex. 1003 ¶ 10 (Dr. Chaitman testimony defining the POSA based on his
`“knowledge and experience in the field and [his] review of the ’941 patent
`and file history”) (cited at Pet. 10 n.3). Petitioner further contends that
`“[a]dditional education or industry experience may compensate for a deficit
`in one of the other aspects of the requirements stated above.” Id.
`
`In its Preliminary Response, Patent Owner took the position that one
`of ordinary skill in the art would have had “specialized engineering skills”
`including “a degree in biomedical or electrical engineering (or an
`equivalent), and/or extensive experience working with tools for detecting
`cardiac conditions.” Prelim. Resp. 9 (citing Ex. 2001 ¶¶ 51–53). Although
`Patent Owner does not expressly define the person of ordinary skill in the art
`post-institution, it appears to argue that such a person would have an
`engineering degree or comparable experience. See PO Resp. 26 (arguing
`that “a cardiologist who is not an engineer ‘lacks the necessary knowledge to
`develop a smartwatch with PPG or ECG sensors’”); Sur-reply 21 (similar);
`but see Tr. 39:20–40:12 (arguing that Patent Owner waived its opportunity
`to propose a definition).
`In our Institution Decision, we noted that
`the research and development of medical devices is often the
`work of a multidisciplinary team, and courts and tribunals have
`frequently identified the hypothetical person of ordinary skill as
`a composite or team of individuals with complementary
`backgrounds and skills. See, e.g., AstraZeneca Pharm. LP v.
`Anchen Pharm., Inc., 2012 WL 1065458, at *19, *22 (D.N.J.
`Mar. 29, 2012), aff'd, 498 F. App’x 999 (Fed. Cir. 2013)
`
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`(collecting cases); Apotex Inc. v. Novartis AG, IPR2017-00854,
`Paper 109 at 10–11 (PTAB July 11, 2018) (collecting cases).
`DI 25. We further determined such a team in the context of the ’941 patent
`might include specialists in electrical engineering, mechanical engineering,
`biomedical engineering, computer scie
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