throbber
UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Cameron R. Elliot
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN WEARABLE ELECTRONIC
`DEVICES WITH ECG FUNCTIONALITY
`AND COMPONENTS THEREOF
`
`Inv. No. 337-TA-1266
`
`RESPONDENT APPLE INC.’S OPENING MARKMAN BRIEF
`
`AliveCor Ex. 2015 - Page 1
`
`

`

`TABLE OF CONTENTS
`
`
`I.
`
`II.
`
`INTRODUCTION ............................................................................................................................. 1
`
`LEVEL OF ORDINARY SKILL IN THE ART .......................................................................... 3
`
`III. OVERVIEW OF THE TECHNOLOGY CLAIMED IN THE ASSERTED
`PATENTS ............................................................................................................................................. 3
`
`A.
`
`Methods and Tools to Monitor a Patient’s Heart Health ................................................. 3
`
`1.
`
`2.
`
`3.
`
`PPG Technology ....................................................................................................... 5
`
`ECG Technology ...................................................................................................... 5
`
`The Asserted Patents ................................................................................................ 7
`
`IV.
`
`APPLICABLE LEGAL PRINCIPLES ........................................................................................... 9
`
`V.
`
`DISPUTED CLAIM TERMS .........................................................................................................10
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`Preamble is Limiting.............................................................................................................10
`
`“alerting said first user to sense an electrocardiogram” (Claim 1)/ “alert”
`(Claim 11) ...............................................................................................................................13
`
`“Heart rate sensor” ...............................................................................................................17
`
`Order of steps (’499 patent) ................................................................................................20
`
`“Confirm the presence of the arrhythmia based on the ECG data” and
`“confirming the presence of the arrhythmia based on the ECG data” ........................23
`
`Order of steps (’731 patent) ................................................................................................26
`
`“To confirm a presence of the arrhythmia”/ “to confirm the presence of the
`arrhythmia” ............................................................................................................................27
`
`H.
`
`“When the activity level is resting” / “when the activity level value is resting”..........31
`
`I.
`
`J.
`
`“Discordance” .......................................................................................................................35
`
`Order of steps .......................................................................................................................38
`
`VI.
`
`CONCLUSION .................................................................................................................................39
`
`
`
`
`
`
`
`
`ii
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`AliveCor Ex. 2015 - Page 2
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`

`

`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Altiris, Inc. v. Symantec Corp.,
`318 F.3d 1363 (Fed. Cir. 2003)................................................................................................................ 20
`
`Apple v. Motorola,
`757 F.3d 1286 (Fed. Cir. 2014) (overruled on other grounds) ........................................................... 22
`
`Bicon, Inc. v. Straumann Co.,
`441 F.3d 945 (Fed. Cir. 2006) .................................................................................................................. 11
`
`Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
`320 F.3d 1339 (Fed. Cir. 2003)................................................................................................................ 12
`
`Catalina Marketing Int’l v. Coolsacings.com, Inc.,
`289 F.3d 801 (Fed. Cir. 2002) .................................................................................................................. 11
`
`Certain Integrated Circuits & Prod. Containing the Same,
`Inv. No. 337-TA-1148, 2020 WL 3819485 (May 22, 2020) .................................................................. 9
`
`Credle v. Bond,
`25 F.3d 1566 (Fed. Cir. 1994) .................................................................................................................. 22
`
`Datamize, LLC v. Plumtree Software, Inc.,
`417 F.3d 1342 (Fed. Cir. 2005), abrogated on other grounds by Nautilus, 134 S. Ct.
`2120 ............................................................................................................................................................. 33
`
`Deere & Co. v. Bush Hog, LLC,
`703 F.3d 1349 (Fed. Cir. 2012)......................................................................................................... 10, 12
`
`Dow Chem. Co. v. Nova Chem. Corp. (Canada),
`803 F.3d 620 (Fed. Cir. 2015) .................................................................................................................. 31
`
`Halliburton Energy Servs., Inc. v. M-I LLC,
`514 F.3d 1244 (Fed. Cir. 2008)................................................................................................................ 11
`
`Hytera Comm’ns Co. Ltd. v. Motorola Solutions, Inc.,
`841 Fed. Appx. 210 (Fed. Cir. 2021) ................................................................................... 21, 22, 24, 39
`
`HZNP Med. LLC v. Actavis Labs. UT, Inc.,
`940 F.3d 680 (Fed. Cir. 2019) .................................................................................................................. 31
`
`Intell. Ventures I LLC v. T-Mobile USA, Inc.,
`902 F.3d 1372 (Fed. Cir. 2018)......................................................................................................... 33, 34
`
`
`
`
`
`iii
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`AliveCor Ex. 2015 - Page 3
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`

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`Interactive Gift Express, Inc. v. Compuserve Inc.,
`256 F.3d 1323 (Fed. Cir. 2001)................................................................................................................ 20
`
`Interval Licensing LLC v. AOL, Inc.,
`766 F.3d 1364 (Fed. Cir. 2014)......................................................................................................... 31, 34
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996) ............................................................. 1, 9, 10
`
`Mformation Technologies, Inc. v. Research In Motion, Ltd.,
`764 F.3d 1392 (Fed. Cir. 2014)................................................................................................................ 39
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014) ........................................................................................................... 31, 34, 35, 36
`
`O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co.,
`521 F.3d 1351 (Fed. Cir. 2008).................................................................................................................. 9
`
`Pacing Techs., LLC v. Garmin Int’l, Inc.,
`778 F.3d 1021 (Fed. Cir. 2015)......................................................................................................... 10, 11
`
`PersonalWeb Technologies LLC v. Int’l Bus. Machines Corp.,
`2017 WL 2180980 (N.D. Cal. May 18, 2017) ........................................................................................ 11
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ................................................................................... 9, 10, 17
`
`Poly-America, L.P. v. GSE Lining Technology, Inc.,
`383 F.3d 1303 (Fed. Cir. 2004)................................................................................................................ 13
`
`In re Smith Int’l, Inc.,
`871 F.3d 1375 (Fed. Cir. 2017)............................................................................................................9, 10
`
`TALtech Ltd. v. Esquel Apparel, Inc.,
`279 Fed. Appx. 974 (Fed. Cir. 2008) ...................................................................................................... 20
`
`United States v. Adams,
`383 U.S. 39 (1966) ....................................................................................................................................... 9
`
`Vitrionics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) .................................................................................................................. 10
`
`Vizio, Inc. v. Int’l Trade Comm’n,
`605 F.3d 1330 (Fed. Cir. 2010)................................................................................................................ 13
`
`Wi-Lan, Inc v. Apple, Inc.,
`811 F.3d 455 (Fed. Cir. 2016) ........................................................................................................... 21, 24
`
`
`
`
`
`
`
`
`
`iv
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`AliveCor Ex. 2015 - Page 4
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`

`

`Respondent’s
`Exhibit No.
`1.
`2.
`3.
`4.
`5.
`6.
`7.
`
`TABLE OF EXHIBITS
`
`Description
`
`Stultz Declaration
`AMON: A Wearable Multiparameter Medical Monitoring and Alert System
`U.S. Patent No. 9,649,042
`Excerpts from U.S. 9,572,499 Prosecution History
`Excerpts from U.S. 10,638,941 Prosecution History
`Excerpt from Merriam Webster Dictionary, Eleventh edition
`Excerpt from Pocket Oxford English Dictionary, Eleventh edition
`
`
`
`v
`
`
`
`
`
`
`
`
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`AliveCor Ex. 2015 - Page 5
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`

`

`I.
`
`INTRODUCTION
`
`Respondent Apple Inc. (“Apple”) respectfully submits this initial Markman brief in support
`
`of its proposed constructions of the disputed claim terms of Complainant AliveCor, Inc.’s
`
`(“AliveCor”) U.S. Patent Nos. 9,572,499 (the ’499 patent”), 10,595,731 (the ’731 patent), and
`
`10,638,941 (the ’941 patent) (collectively, the Asserted Patents).
`
`The three Asserted Patents are all directed to systems and methods for determining cardiac
`
`arrhythmias using heart rate data and electrocardiogram (ECG) data collected from separate sensors.
`
`See, e.g., ’499 patent, claims 1 and11; ’731 patent, claims 1, 17, and 25; and ’941 patent, claims 1 and
`
`12. For the ’731 and ’941 patents, all claims require that the sensors comprise part of a
`
`“smartwatch,” and for the ’499 patent, at least dependent claims 6 and 16 require the same.
`
`Notably, the claimed methods and systems first use heart rate data to determine that the user may
`
`have “an arrhythmia,” and then use ECG data to verify the same arrhythmia. See, e.g., ’941 patent,
`
`claim 1. Thus, based on their plain language, the claimed systems and methods link the
`
`determination of “an arrhythmia” using a first sensor with a verification of “the arrhythmia” by the
`
`ECG measurement. Additionally, the independent claims of the ’499 patent (claims 1 and 11) and
`
`the ’941 patent (claims 1 and 12), and some of the dependent claims of the ’731 patent (e.g., claims 2
`
`and 18), require the claimed systems and methods to measure an activity level or motion level of the
`
`user in determining whether the user has “an arrhythmia” that is subsequently verified by the ECG
`
`data.
`
`The ’499 and ’731 patents are related and share a common specification. The ’941 patent
`
`was filed later in time, in 2015, and has a different specification from the first two patents. As
`
`described in the previous paragraph, however, all three patents are directed to the same field of
`
`alleged invention.
`
`
`
`1
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`AliveCor Ex. 2015 - Page 6
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`The parties have identified ten terms/issues for claim construction: three terms from the
`
`’499 patent, one term from the ’731 patent, three terms from the ’941 patent, and one issue that
`
`spans all three patents (but which is counted as three different issues):
`
`1. Whether the preambles of claims 1 and 11 of the ’499 patent are limiting (’499 patent)
`
`2. “alerting said first user to sense an electrocardiogram”/ “alert” (’499 patent)
`
`3. “heart rate sensor” (’499 patent)
`
`4. “confirming the presence of the arrhythmia based on the ECG data”/ “confirm the
`presence of the arrhythmia based on the ECG data” (’731 patent)
`
`5. “to confirm the presence of the arrhythmia” (’941 patent)
`
`6. “when the activity level is resting”/ “when the activity level value is resting” (’941 patent)
`
`7. “discordance” (’941 patent)
`
`8. Whether the steps of the method claims must be performed in order (independent method
`claims of ’499, ’731, and ’941 patents).
`
`(See 9/13/21 Joint Disclosure of Proposed Claim Constructions (EDIS Doc. ID No. 751576).) As
`
`detailed below for the claim terms, Apple’s proposed constructions accurately state how a person of
`
`ordinary skill in the art in December 2013 (the alleged date of the purported invention of the ’499
`
`and ’731 patents) would have understood the terms in question.1 With respect to the order of steps
`
`of the independent method claims, the grammar and logic of the claims themselves dictate that the
`
`steps of the asserted methods must be performed in the order listed.
`
`Accordingly, the Court should adopt Apple’s proposed constructions for each of the
`
`terms/issues presented for construction.
`
`
`1 The ’941 patents has a later priority date of May 2015. That later priority date does not materially
`change how a person of ordinary skill in the art would have understood any of the disputed terms,
`or the general scope of the claims.
`
`
`
`2
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`AliveCor Ex. 2015 - Page 7
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`

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`II.
`
`LEVEL OF ORDINARY SKILL IN THE ART
`
`Apple maintains that a person having ordinary skill in the art (“PHOSITA”) at the time of
`
`the alleged inventions in December 2013 (the alleged priority for the ’499 and ’731 patents) would
`
`have at least a bachelor of science in electrical engineering, mechanical engineering, biomedical
`
`engineering, computer science, or a related discipline, with at least two years of relevant work
`
`experience designing wearable devices and/or sensors for measuring physiological signals or
`
`parameters of mammals. A greater amount of education, i.e., a doctorate in electrical engineering,
`
`mechanical engineering, biomedical engineering, computer science, or a related discipline with a
`
`focus on designing wearable devices and/or sensors for measuring physiological signals or
`
`parameters of mammals would also qualify for the hypothetical person of ordinary skill in the art in
`
`lieu of fewer years of work experience. Alternatively, a hypothetical person of ordinary skill in the
`
`art could also be a person with a medical degree (M.D. or D.O.) and with at least two years of work
`
`experience using biomedical sensors and/or analyzing their data (in the context of industry, in
`
`biomedical academic research, or in practice treating patients). Additional relevant industry
`
`experience may compensate for lack of formal education or vice versa. The definition for a
`
`PHOSITA would remain the same through May 2015, the priority date of the ’941 patent.
`
`III. OVERVIEW OF THE TECHNOLOGY CLAIMED IN THE ASSERTED
`PATENTS
`
`A. Methods and Tools to Monitor a Patient’s Heart Health
`
`When assessing heart health, medical professionals routinely use various physiological
`
`measurements of a patient. These may include (1) measuring a patient’s pulse through manual
`
`palpation, e.g., a doctor feeling a patient’s pulse at the wrist, (2) using a stethoscope/electronic
`
`stethoscope to listen to a patient’s heart beats through the chest wall, (3) using a
`
`stethoscope/electronic stethoscope to listen to a patient’s pulse at an appendage, (4) using
`
`photoplethysmography (PPG) sensors—often found in pulse oximeter machines—to measure and
`
`
`
`3
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`AliveCor Ex. 2015 - Page 8
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`

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`calculate, among other things, a patient’s heart rate, heart rate variability, and blood oxygen
`
`saturation, (5) using an electrocardiogram to measure the electrical activity of the patient’s heart, and
`
`(6) measuring a patient’s blood pressure. (Exh. 1 (Stultz Decl.) at ¶ 38.) These are just a few of the
`
`tools available to medical professionals to help monitor a patient’s heart health, most of which have
`
`been known and used for at least three decades. (Exh. 1 (Stultz Decl.) at ¶¶ 36, 53, 56, 59-60.)
`
`Some of these tools and methods measure heart rate directly (e.g., stethoscope/electronic
`
`stethoscope2), some measure changes in blood flow through blood vessels (e.g., PPG sensors, blood
`
`pressure sensors), from which heart rate and heart rate variability (HRV) can be derived, and others
`
`measure the electrical depolarization of the heart muscle across the four chambers of the heart (e.g.,
`
`ECG), which also allows a calculation of heart rate and HRV. (Exh. 1 (Stultz Decl.) at ¶¶ 36, 38, 54,
`
`56.)
`
`Heart rate is simply the rate at which the heart beats over a defined period of time. (Exh. 1
`
`(Stultz Decl.) at ¶ 36.). Heart rate variability (HRV) is a calculation of the variation in time between
`
`consecutive heartbeats. (Exh. 1 (Stultz Decl.) at ¶ 36.). The human heart does not beat at a
`
`constant rhythm, i.e., it does not beat like a metronome. (Exh. 1 (Stultz Decl.) at ¶ 35.) Rather,
`
`there is a variation in the time between heartbeats over time, and this is what HRV calculates. (Exh.
`
`1 (Stultz Decl.) at ¶¶ 35-36, 49.) HRV can be important because if the variation between beats is
`
`“irregularly, irregular,” that is an indication of a possible heart condition or that an arrhythmia may
`
`be present. (Exh. 1 (Stultz Decl.) at ¶¶ 35-36, 49.)
`
`
`2 (See, e.g., Exh. 3 (U.S. Patent No. 9,649,042 (Appl. No. 13/964,490) (herein after “’042 patent”) at
`4:33-35) (“Heart beat and heart rate can be detected as well using a conventional microphone
`assisted stethoscope 16 . . .”).)
`
`
`
`4
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`AliveCor Ex. 2015 - Page 9
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`

`

`1.
`
`PPG Technology
`
`Medical professionals have long used PPG sensors to measure heart rate and heart rate
`
`variability, among other things. PPG sensors use light to measure the absorption rate as blood flows
`
`through a patient’s blood vessels. Specifically, a source shines light at particular wavelengths into the
`
`body. The amount of light that is detected by a sensor after it passes through a body part (e.g., a
`
`fingertip or an earlobe) in “transmittal PPG,” or the amount of light that is reflected back out of the
`
`body as detected by a light sensor in “reflective PPG” is used to determine, among other things, the
`
`pulse of the patient. (Exh. 2 (“AMON”) at 417-18; id. at Exh. 1 (Stultz Decl.) at ¶¶ 53-56.). The
`
`pulse data from the PPG can then be used to derive heart rate and HRV, among other things.
`
`Notably, as long as a user is wearing a PPG sensor, for example, on a smartwatch, the PPG sensor
`
`can continuously monitor the user/measure blood flow in the user without any input from the user
`
`other than wearing the device. In other words, the monitoring can all happen in the background
`
`without the user having to activate a measurement.
`
`2.
`
`ECG Technology
`
`An ECG measures the small electrical changes in the skin generated from the depolarization
`
`of the four chambers of the heart muscle.3 (See Exh. 3 (U.S. Patent No. 9,649,042 (Appl. No.
`
`13/964,490)) at 4:39-41.) That depolarization creates an electrical impulse that can be measured by
`
`electrodes placed on the skin of the body. Notably, “well-established physical principles dictate that
`
`meaningful, and robust, ECG signals are obtained by placing electrodes either on the torso itself or
`
`on opposite sides of the body, e.g., one electrode on the left side of the torso and one electrode on
`
`the right side of the torso.” (Exh. 1 (Stultz Decl.) at ¶ 51; see also Exh. 3 (’042 patent) at 4:41-46.)
`
`
`3 Depolarization of the heart is the movement of sodium, potassium, and calcium through specific
`channels across the membrane of cardiac muscle cells. That movement changes the polarity of the
`cardiac muscle cell, making them less negative, and causing contraction of the cardiac muscle fibers
`to occur. (See Exh. 1 (Stultz Decl.) at ¶ 28.)
`
`
`
`5
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`AliveCor Ex. 2015 - Page 10
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`

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`This is because it is necessary to measure the electrical activity across the heart, given that the heart
`
`is an electric dipole that sits in the torso.
`
`
`
`
`
`(See Exh. 1 (Stultz Decl.) at ¶ 41.)
`
`Thus, electrodes placed on either side of the torso are used to measure current flow through
`
`the heart. In other words, meaningful ECG signals are obtained when the path between the two
`
`electrodes includes the torso, as that measures the electrical activity across the heart during the
`
`depolarization that takes place each time the heart beats. (Exh. 1 (Stultz Decl.) at ¶¶ 41, 51); see also
`
`Exh. 3 (’042 patent) at 4:39-46.)
`
`If both electrodes used to measure an ECG were on the same device, e.g., both electrodes
`
`are on a smartwatch that can measure an ECG, then it would be necessary for one of the electrodes
`
`to touch the one arm and the other electrode to touch the opposite arm to take an ECG. (Exh. 1
`
`(Stultz Decl.) at ¶¶ 51-52.) One way to accomplish this is to place one of the ECG electrodes on the
`
`underside of the smartwatch case such that it touches the wrist of the one arm of the user. The user
`
`would then touch the other electrode on the smartwatch with a finger (or other portion) of his
`
`opposite arm to “close the loop” to allow the smartwatch to measure the electrical activity across the
`
`heart. The Asserted Patents provide examples of these types of orientations for the electrodes to
`
`take an ECG using the claimed systems and methods:
`
`
`
`6
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`AliveCor Ex. 2015 - Page 11
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`

`For example, a user wearing a smartwatch with heart rate and activity level
`monitoring receives an audible and/or visual indication from the smartwatch to
`sense an ECG when a discordance is present between a sensed heart rate value
`and a sensed activity level value. In some embodiments, the smartwatch
`comprises one or more electrodes and a user contacts one electrode with the
`left side of their body and one electrode with the right side of their body when
`an indication is received to do so from the smartwatch because a discordance is
`present thus sensing an ECG.
`
`(’941 patent, 15:7-21; see also id. at 13:31-51; ’499 patent, 13:37-14:3, ’731 patent, 13:47-14:13.)
`
`B.
`
`The Asserted Patents
`
`The three Asserted Patents are all directed to “devices, systems, and methods for managing
`
`health and disease such as cardiac diseases, including arrhythmia and atrial fibrillation.” (’499 patent,
`
`2:8-10; see also ’731 patent, 2:17-19 (same); ’941 patent, 1:26-33.) The parties have agreed that for
`
`purposes of the Asserted Patents, “arrhythmia” means “a cardiac condition in which the electrical
`
`activity of the heart is irregular or is faster or slower than normal.” (9/13/21 Joint Disclosure of
`
`Proposed Claim Constructions (EDIS Doc. ID No. 751576) at 5.)
`
`The claims of all three Asserted Patents specifically include, among other things, sensors that
`
`monitor heart activity of a user. For example, the independent claims of the ’499 patent require a
`
`“heart rate sensor,” and the independent claims of the ’731 and ’941 patents require a PPG or other
`
`sensor. See ’499 patent, claims 1, 11; ’731 patent, claims 1, 17, 25; ’941 patent, claims 1, 12.
`
`The claims of all three Asserted Patent use the data from the heart monitoring sensors to
`
`measure a heart rate parameter, and that heart rate parameter is then used to detect if the user has an
`
`irregularity/“an arrhythmia” in their heart activity. If an irregularity/arrhythmia is detected by the
`
`first sensor data, then the claimed methods and systems take an ECG (using an ECG sensor) to
`
`verify the arrhythmia that was detected by the first heart rate sensor.
`
`Specifically, in the ’499 patent, the data from the first “heart rate sensor” is used to
`
`determine the HRV of the user, and if an irregularity in the HRV is present, the claimed method and
`
`system triggers the user to take an ECG. (See ’499 patent, claims 1, 11.) Similarly, in the ’731 and
`
`
`
`7
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`AliveCor Ex. 2015 - Page 12
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`

`

`’941 patents, the PPG/heart rate sensor data is used to detect “an arrhythmia” of the user, and when
`
`detected, the claimed methods and systems then trigger the user to take an ECG to verify “the
`
`arrhythmia.” (See ’731 patent, claims 1, 17, 25; ’941 patent, claims 1, 12.) This is clearly
`
`contemplated and explained by Figure 10 of the ’499 and ’731 patents:
`
`(’499 patent, 23:12-32, Fig. 10; ’731 patent, 23:20-40, Fig. 10.) The same concept is disclosed in the
`
`’941 patent and captured by its claims. (See ’941 patent, 14:47-67, 15:7-59, Fig. 7.)
`
`
`
`
`
`
`
`8
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`AliveCor Ex. 2015 - Page 13
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`C. What Was Knowing In the Art By December 2013
`
`Combining heart rate data from a first heart rate sensor with ECG data from an ECG sensor
`
`on a wrist-worn device to detect cardiac conditions, including arrhythmias, was known as early as
`
`2004—nearly a decade before the alleged inventions of the Asserted Patents. Integrating these
`
`components and functionalities into a smartwatch was commonly described throughout the relevant
`
`literature by the time of the alleged inventions of the Asserted Patents. Indeed, at its core, these
`
`alleged inventions are directed to (1) using heart rate data from one measurement to signal a possible
`
`arrhythmia, and then (2) verifying that possible arrhythmia with an ECG, which general practitioners
`
`and cardiologists have been doing for at least 50 years (or longer). (Exh. 1 (Stultz Decl.) at ¶ 59, 60.)
`
`IV.
`
`APPLICABLE LEGAL PRINCIPLES
`
`Claim construction is a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979
`
`(Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996). “Words of a claim are generally given their ordinary and
`
`customary meaning, which is the meaning a term would have to a person of ordinary skill in the art
`
`after reviewing the intrinsic record at the time of the invention.” O2 Micro Int’l Ltd. v. Beyond
`
`Innovation Tech. Co., 521 F.3d 1351, 1360 (Fed. Cir. 2008); Certain Integrated Circuits & Prod. Containing
`
`the Same, Inv. No. 337-TA-1148, Initial Det., 2020 WL 3819485 at *10 (May 22, 2020) (Elliot, J.)
`
`(citing cases).
`
`The specification is “the single best guide to the meaning of a disputed term” and is usually
`
`dispositive. Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc). Thus, claim
`
`terms should be construed in light of the specification “with a view to ascertaining the invention.”
`
`Id. (citing United States v. Adams, 383 U.S. 39, 49 (1966)). “The correct inquiry” for purposes of claim
`
`construction “is not whether the specification proscribes or precludes some broad reading of the
`
`claim term.” In re Smith Int’l, Inc., 871 F.3d 1375, 1382-83 (Fed. Cir. 2017). Rather, the correct
`
`construction must “correspond[] with . . . how the inventor describes his invention in the
`
`
`
`9
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`AliveCor Ex. 2015 - Page 14
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`specification, i.e., an interpretation that is consistent with the specification.” Id. at 1383 (citation and
`
`internal quotation marks omitted).
`
`Although intrinsic evidence is critical in the claim construction process, courts are also
`
`authorized to consider extrinsic evidence, including “expert and inventor testimony, dictionaries,
`
`and learned treatises.” Phillips, 415 F.3d at 1317 (citations omitted). Such extrinsic evidence is
`
`particularly appropriate for use in the claim construction process where it helps the court “‘to better
`
`understand the underlying technology’ and the way in which one of skill in the art might use the
`
`claim terms.” Id. at 1318 (citing Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 n.6 (Fed. Cir.
`
`1996)). Such evidence can often elucidate “the true meaning of language used in the patent claims.”
`
`Markman, 52 F.3d at 980.
`
`V.
`
`DISPUTED CLAIM TERMS
`
`A.
`
`Preamble is Limiting4
`
`Complainant’s Construction
`Preambles are not limiting
`
`Respondents’ Construction
`The preambles of claims 1
`and 11 are limiting.
`
`Staff’s Construction
`The preambles of the
`asserted claims are limiting.
`
`’499 Patent: claims 1 and 11
`
`
`
`The preambles to claims 1 and 11 of the ’499 patent—which recite a method and system for
`
`“determining the presence of an arrhythmia”—limits the scope of the claims. Staff agrees that the
`
`preambles are limiting.
`
`It is well established that a claim’s preamble limits the scope where it “gives life, meaning,
`
`and vitality to the claim.” Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1357 (Fed. Cir.
`
`2012)(internal citations omitted). Among the ways in which a preamble does so is when it is
`
`necessary to help understand the claim or when it provides antecedent basis for a claim term. See
`
`Pacing Techs., LLC v. Garmin Int’l, Inc., 778 F.3d 1021, 1024 (Fed. Cir. 2015); Deere, 703 F.3d at 1358;
`
`
`4 This discussion applies to the preambles that appear in claims 1 and 11 of the ’499 patent.
`
`
`
`10
`
`AliveCor Ex. 2015 - Page 15
`
`

`

`Catalina Marketing Int’l v. Coolsacings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). The preamble to
`
`claims 1 and 11 of the ’499 patent does each of these things— it provides antecedent basis for
`
`dependent claims in the ’499 patent, and it provides essential meaning for the claimed method and
`
`system. ’499 patent, cl. 7 (26:54-67), cl. 17 (28:12-14).
`
`First, the preambles of claims 1 and 11 each provide antecedent basis for the “said
`
`arrhythmia” limitations, as recited in dependent claims 7, 8, 9, 17, 18, and 19. The requisite
`
`antecedent basis for “said arrhythmia”—“an arrhythmia”—appears only in the preambles of claims
`
`1 and 11, respectively. A claim drafter may use “both the preamble and the body of the claim to
`
`define the subject matter of the claimed invention” by including essential features of the claim in the
`
`preamble. Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952-953 (Fed. Cir. 2006)(finding preamble is
`
`limiting when it provides antecedent basis for another limitation in the body of the claim). And
`
`when the body of a dependent claim term finds its requisite antecedent basis in the preamble of an
`
`independent claim from which it depends, the preamble should be treated as limiting. Pacing Techs.,
`
`LLC, 778 F.3d at 1024 (finding preamble of independent claim limiting where a term in preamble
`
`provided the antecedent basis for a term in a dependent claim); PersonalWeb Technologies LLC v. Int’l
`
`Bus. Machines Corp., 2017 WL 2180980 at *13 (N.D. Cal. May 18, 2017)(finding preamble as
`
`providing antecedent basis for terms in dependent claim). Here, the patentee chose to include
`
`antecedent basis for later claims/claim elements in the preamble itself.
`
`If the preamble were not limiting in this case, as AliveCor contends, then there would be no
`
`understanding by a PHOSITA as to what arrhythmia is being referred to by “said arrhythmia,” and
`
`those claims would be indefinite. ’499 patent, cls. 7, 8, 9, 17, 18, and 19.5 Therefore, to avoid
`
`
`5 Where one of ordinary skill in the art, considering the intrinsic evidence, would not be able to
`discern the correct antecedent basis for the claim, the Court may find the claim invalid for being
`indefinite. See, e.g., Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1250 (Fed. Cir. 2008)
`
`
`
`11
`
`AliveCor Ex. 2015 - Page 16
`
`

`

`indefiniteness, and to understand what “said arrhythmia” refers to, a PHOSITA would have no
`
`other choice but to look to the preamble to “define the subject matter of the claimed invention.” In
`
`doing so, a PHOSITA would understand “said arrhythmia” in dependent claims 7, 8, 9, 17, 18, and
`
`19 refers to “an arrhythmia” recited in the preamble of independent claims 1 and 11.
`
`Second, the preambles of claims 1 and 11 disclose to one of ordinary skill in the art the
`
`“fundamental characteristic of the claimed invention”—“determining the presence of an arrhythmia
`
`of a first user.” Deere, 703 F.3d at 1358. A preamble should be construed as limiting if it presents
`
`“not merely circumstances in which the method [or system] may be useful, but instead [is] the raison
`
`d’etre of the claimed method itself.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d
`
`1339, 1345 (Fed. Cir. 2003) (emp

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