Apple Inc. v AliveCor, Inc.
`
`IPR2021-00970
`IPR2021-00971
`IPR2021-00972
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`U.S. Patent Nos. 9,572,499; 10,595,731; 10,638,941
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`Patent Owner’s Demonstratives
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`Hearing: September 14, 2022
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`1
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`IPR2021-00970
`IPR2021-00971
`IPR2021-00972
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`U.S. Patent Nos. 9,572,499; 10,595,731; 10,638,941
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`Patent Owner’s Demonstratives
`
`Hearing: September 14, 2022
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`1
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`’499 and ’731 Patents – Background
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`• The ’499 and ’731 patents describe arrhythmia detection using a novel
`combination of PPG detection, ECG confirmation, and machine learning.
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`POR at 17-19
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`Ex. 1001 (’499 Patent) at Abstract, Fig. 10
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`2
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`’731 Patent Claims
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`Ex. 1001 (’731 Patent) at Cl. 1, 3; POR at 18-19
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`3
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`’499 Patent Claims
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`4
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`Ex. 1001 (’499 Patent) at Cl. 1, 7; POR at 27-28, 62
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`Challenged Patents: AliveCor’s Invention
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`IPR2021-00971 POR at 4
`Ex. 1001 (’731 Patent) at 1:34-39
`Ex. 1001 (’499 Patent) at 1:25-30.
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`IPR2021-00971 Reply at 8
`Ex. 1001 (’731 Patent) at 1:66-2:13
`Ex. 1001 (’499 Patent) at 1:57-2:4
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`5
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`Challenged Patents: AliveCor’s Invention
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`Ex. 1001 (’731 Patent) at 9:8-11 (’499 Patent) at 8:65-9:1
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`Ex. 1001 (’731 Patent) at 8:38-42 (’499 Patent) at 8:28-31
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`6
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`Challenged Patents: AliveCor’s Invention
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`Ex. 1001 (’731 Patent) at 8:38-63
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`7
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`’941 Patent – Background
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`8
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`’941 Patent Claims
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`Ex. 1001 (’941 Patent) at Cl. 1, 2; POR at 17-18
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`9
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`Challenged Patents: AliveCor’s Invention
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`IPR2021-00942 POR at 28
`Ex. 1001 (’941 Patent) at 13:52-14:42
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`10
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`Background: PPG vs. ECG
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`IPR2021-00970, POR at 23; Ex. 1016
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`11
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`Background: PPG vs. ECG
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 21;
`Ex. 2016, ¶20
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`12
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`Background: PPG vs. ECG
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 20;
`Ex. 2018 (Stultz Deposition) 62:9-21
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`13
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`Background: PPG vs. ECG
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`• The record evidence establishes that ECG is the gold standard for arrhythmia
`detection, including atrial fibrillation.
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`IPR2021-00970, POR at 20; Ex. 2023
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`14
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`Background: PPG vs. ECG
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 20;
`Ex. 2017 (Chaitman Deposition) 54:13-55:3
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`15
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`Background: PPG vs. ECG
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`POR, 7-11; Ex. 2023
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`16
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`Claim Construction: Arrhythmia
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`IPR2021-00970, POR at 23; Ex. 1001 (’499 Patent) at 1:31-45
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`17
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`Claim Construction: ITC ’499 Patent Constructions
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`• On balance, therefore, the preambles of claims 1 and 11 of the
`499 patent are limiting
`
`• Therefore, the terms “alerting said first user to sense an
`electrocardiogram” and “alert” are accorded their plain and
`ordinary meaning, the “alert” is not limited to a message, and
`the terms need not otherwise be construed.
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`• Therefore, the term “heart rate sensor” is accorded its plain and
`ordinary meaning, and in particular is construed to mean heart
`rate sensors that sense heart rate both directly and indirectly,
`and is not otherwise construed.
`
`• Therefore, claim 1 of the 499 patent is construed such that the
`step of “sensing an activity level of said first user with a motion
`sensor” need not be performed after the step of “determining,
`using said mobile device, a heart rate variability of said first
`user based on said heart rate of said first user.”
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`POR at 31; Ex. 2010 (ITC Claim Construction Order)
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`18
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`Claim Construction: ITC ’499 Patent Constructions
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`POR at 31; Ex. 2010 (ITC Claim Construction Order)
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`19
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`Claim Construction: ITC ’731 Patent Constructions
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`• Therefore, the terms “confirm the presence of the arrhythmia
`based on the ECG data” and “confirming the presence of the
`arrhythmia based on the ECG data” are accorded their plain and
`ordinary meaning, with no requirement of a comparison of the
`ECG data to the PPG data.
`
`• Therefore, claim 17 of the 731 patent is construed such that the
`step of “receiving PPG data from a PPG sensor of the
`smartwatch” must be performed before the step of “detecting
`by a processing device, based on the PPG data, the presence of
`an arrhythmia,” and the step of “receiving ECG data from an
`ECG sensor of the smartwatch” must be performed before the
`step of “confirming the presence of the arrhythmia based on the
`ECG data,” but there is otherwise no restriction on the order of
`the steps.
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`POR at 21; Ex. 2010 (ITC Claim Construction Order)
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`20
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`Claim Construction: ITC ’941 Patent Constructions
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`• The specification and claims do, therefore, sufficiently define
`the metes and bounds of the claimed inventions, and claims 1
`and 12 are not indefinite because of the “activity level [value]
`is resting” language.
`
`• Therefore, the term “discordance” is accorded its plain and
`ordinary meaning.
`
`• Therefore, method claim 1 of the 941 patent is construed such
`that the step of “when the activity level is resting, sensing a
`heat rate parameter of the user with a second sensor on the
`smartwatch” may be performed after or simultaneously with the
`step of “sensing an activity level of a user with a first sensor on
`a smartwatch worn by the user,” and the step of “receiving
`electric signals of the user from an [ECG] on the smartwatch to
`confirm a presence of the arrhythmia” need not be performed
`last.
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`POR at 21; Ex. 2010 (ITC Claim Construction Order)
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`21
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Apple: Shmueli’s “irregular heart conditions” encompass arrhythmia.
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`22
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`Petition at 31; Ex. 1004 (Shmueli) at 4
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Apple: Shmueli’s “irregular heart conditions” encompass arrhythmia.
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`IPR2021-00970, POR at 53, Ex. 2017 (Chaitman Deposition) at 73:16-20
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`23
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Dr. Efimov: “there are numerous other irregular heart conditions” including
`“coronary heart disease, heart failure, congenital heart defects, and various
`heart-valve defects, among others.”
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`POR at 53-54; IPR2021-00970, Ex. 2018 (Efimov Declaration)
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`24
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Apple’s dictionaries teach multiple “irregular heart conditions.”
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`• Exhibit 1023: Merriam Webster Dictionary
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`• Exhibit 1047: Blacks Medical Dictionary
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`IPR2021-00970, POR at 53; Ex. 1023
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`IPR2021-00970, POR at 53; Ex. 1047
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`25
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Apple ignores genus/species law:
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`It is well established that the disclosure of a genus in the prior art is not
`necessarily a disclosure of every species that is a member of that genus. See,
`e.g., In re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994). There may be many
`species encompassed within a genus that are not disclosed by a mere
`disclosure of the genus.
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`Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006)
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`IPR2021-00970, POR at 54
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`26
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• With respect to
`genus/species law,
`Apple’s Reply misses
`the point.
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`IPR2021-00970, Sur-Reply at 5-7
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, Reply at 10
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`27
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Apple: “irregular heart condition” refers to arrhythmia based on Shmueli’s teaching
`that SpO2 and PPG have the same meaning.
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`Petition at 8
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`Ex. 1004 (Shmueli) at 8
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`28
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Shmueli only teaches
`measuring oximetry
`(SpO2) and carbon dioxide
`(CO2).
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`• Shmueli does not teach
`measuring heart rate.
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`POR at 42-46
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`IPR2021-00970, POR at 42, 55; Ex. 1004 (Shmueli) at 9
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`29
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• SpO2 is used to diagnose heart attacks
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 23-24; Ex. 2025
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`30
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Dr. Chaitman: Figure 7 teaches measuring SpO2:
`POR at 32-34
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`Ex. 2017 at 72:21-24
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`POR at 32-34; Ex. 1004 (Shmueli) at Fig. 7
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`31
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`A POSITA Would Not Have Combined Shmueli and Osorio: Shmueli
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`• Dr. Stultz and Dr. Chaitman:
`heart attack and arrhythmia
`detection are night and day.
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`IPR2021-00970, POR at 24
`
`…
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`Ex. 2017 (Chaitman Deposition) at 51:15-18
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`Ex. 2018 (Stultz Deposition) at 74:18-75:16
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`32
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`A POSITA Would Not Have Combined Shmueli and Osorio: Osorio
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`• Osorio teaches detecting epileptic seizures:
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`IPR2021-00970, POR at 46; Ex. 1005 (Osorio) at [0002]
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`IPR2021-00970, POR at 46; Ex. 1005 (Osorio) at [0056]
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`IPR2021-00970, POR at 46; Ex. 1005 (Osorio) at [0037]
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 46; Ex. 1005 (Osorio) at [0046]
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`33
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`A POSITA Would Not Have Combined Shmueli and Osorio: Osorio
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`• Osorio: “body data variability” selected
`from a set of body data that includes:
`
`• respiratory data (respiratory rhythm
`variability, respiratory sinus
`arrhythmia)
`
`• neurological data (neurological index
`frequency band)
`
`• pupil data (pupillary diameter
`variability)
`
`• among others
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`IPR2021-00970, POR at 46-48
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 48;
`Ex. 1005 (Osorio) at [0071]
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`34
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`A POSITA Would Not Have Combined Shmueli and Osorio: Osorio
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`• Osorio: body data variability (BDV) is
`measured to ascertain whether it’s in a
`“pathological range.”
`
`• If outside a pathological range, the
`method “may declare a pathological
`state.”
`
`• The pathological state may be “a
`seizure.”
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`IPR2021-00970, POR at 46-48
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`IPR2021-00970, POR at 46-48
`Ex. 1005 (Osorio) at [0071]
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`35
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`A POSITA Would Not Have Combined Shmueli and Osorio: Osorio
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`• Osorio refers to tachycardia in the context of epileptic seizures.
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`IPR2021-00970, POR at 48; Ex. 1005 (Osorio) at [0045]-[0046]
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`36
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`A POSITA Would Not Have Combined Shmueli and Osorio: Osorio
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`• Dr. Chaitman:
`
`It’s important to distinguish
`between conditions affecting the
`nervous system (e.g., epileptic
`seizures) and cardiac conditions
`(e.g., arrhythmia).
`
`IPR2021-00970, POR at 59
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`IPR2021-00970, POR at 59; Ex. 2017 (Chaitman Deposition) at 103:15-104:24
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`37
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`A POSITA Would Not Have Combined Shmueli and Osorio: Osorio
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`• “Respiratory sinus arrhythmia” is not a cardiac arrhythmia.
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 14; Ex. 2020
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`38
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`
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`A POSITA Would Not Have Combined Shmueli and Osorio
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`• Because neither Shmueli nor Osorio are directed to arrhythmia, the combination
`would “alter[] the principles of operation” of both references.
`
`The Board therefore determined that combining Reed with Nishida would "require the
`alteration of the principles of operation of Reed or would render Reed inoperable for its
`intended purpose." J.A. 93-95.
`
`ADIDAS AG v. Nike Inc., 963 F.3d 1355, 1358-59 (Fed. Cir. 2020)
`
`Fundamental differences between the references are central to this motivation to
`combine inquiry. Thus, while the Board construed the Base Claims as encompassing pre-
`seamed and unseamed garments and garment sections, the Board properly considered the
`fundamental differences in the seaming techniques of Reed and Nishida.
`
`IPR2021-00971,
`Sur-Reply at 16-17
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`Id. at 1359
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`39
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`Lee 2013 Does Not Teach “AFib Detection” As Claimed
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`• ’941 patent (IPR2021-00972): Apple relies on Lee 2013 for AFib detection:
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`• Lee 2013 does not use ECG to detect AFib as required by claims.
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`Petition at 1; POR at 56-58
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`40
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`Lee 2013 Does Not Teach “AFib Detection” As Claimed
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`IPR2021-00972, POR at 56-57; Ex. 1011 (Lee 2013) at Abstract
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`41
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`Lee 2013 Does Not Teach “AFib Detection” As Claimed
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`IPR2021-00972, POR at 56-57; Ex. 1011 (Lee 2013) at 29
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`42
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`Lee 2013 Does Not Teach “AFib Detection” As Claimed
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`• ’941 patent claims:
`
`• AFib is confirmed using an ECG
`sensor on a smartwatch.
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`POR at 56-58; Sur-Reply 19-21
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`Ex. 1001 (’941 Patent) at Cl. 1, 2; POR at 56-58; Sur-Reply 19-21
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`43
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`Shmueli Does Not Teach “Confirming”
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`• Apple: Shmueli’s Figure 7
`“contemplates using ECG data to
`confirm the initial detection of an
`irregular heart condition using PPG
`data.”
`
`IPR2021-00971, Pet. at 12
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`• Apple: the disclosure of search
`correlations to “enhance the detection
`algorithms” teaches “confirming.”
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`IPR2021-00971, Pet. at 26
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`Petition at 12, 26; Ex. 1004 (Shmueli) at Fig. 7
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`44
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`Shmueli Does Not Teach “Confirming”
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`• Dr. Chaitman:
`
`• “[D]etection of irregular heart
`conditions” is done using the SpO2
`measurements only.
`
`• Searching for correlation is an
`optional feature.
`IPR2021-00970, POR at 54
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`IPR2021-00970, POR at 54; Ex. 2017 (Chaitman Depo) at 88:3-7
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`IPR2021-00970, POR at 54; Ex. 2017 (Chaitman Depo) at 86:11-16
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`45
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`Dr. Chaitman – Lack of Qualifications
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 38-39;
`Ex. 2017 at 27:23-28:1
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`46
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`
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`Dr. Chaitman – Lack of Qualifications
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 38-39;
`Ex. 2017 at 27:23-28:1
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`47
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`
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`• ’499 patent:
`
`• ’731 patent:
`
`• Apple also argues machine learning is taught by Shmueli alone.
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`Petition (‘731) at 1, 68-69; Petition (‘499) at 1, 71
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`48
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`
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`IPR2021-00971 POR at 18
`Ex. 1001 (’731 Patent) at 9:8-11
`Ex. 1001 (’499 Patent) at 8:65-9:1
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00971 POR at 18
`Ex. 1001 (’731 Patent) at 3:59-4:10
`Ex. 1001 (’499 Patent) at 3:50-4:1
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`49
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`
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`POR 25-26; Ex. 1001 (’731 Patent) at Claim 3; see also claim 19
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`POR 62-63; Ex. 1001 (’499 Patent) at Claim 7
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`POR 25-26; Ex. 1001 (’731 Patent) at Claim 5; see also claim 21
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`POR 62-63; Ex. 1001 (’499 Patent) at Claim 11
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`POR 25-26; Ex. 1001 (’731 Patent) at Claim 6; see also claim 22
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`50
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`IPR2021-00942 at 28-29
`Ex. 1001 (’941 Patent) at 13:52-14:42
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`51
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`IPR2021-00970, POR at 38-39; Ex. 2017 at 27:23-28:1
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`52
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`
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`• Dr. Chaitman: no experience with “known arrhythmia detection techniques”
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`IPR2021-00970, POR at 38-39; Ex. 2017 at 108:6-109:24
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`53
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`
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`The Prior Art Does Not Render “Machine Learning” Obvious
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`• Dr. Chaitman: no experience with “known arrhythmia detection techniques”
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00970, POR at 38-39;
`Ex. 2017 at 109:3-19
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`54
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`
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`’499 Patent: “Machine Learning” Not Obvious
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`• Apple: Shmueli/Osorio + Hu 1997 detects arrhythmia based on PPG data
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`IPR2021-00971, Pet. at 72
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00971, Pet. at 72
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`55
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`
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`’499 Patent: “Machine Learning” Not Obvious
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`• Hu 1997 does not teach PPG
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`• Hu 1997 teaches ECG only
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`IPR2021-00970, POR at 64-65; Ex. 1049 (Hu 1997) at 1
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`56
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`’731 Patent: “Machine Learning” Not Obvious
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`IPR2021-00971, POR at 60-62; Ex. 1006 (Li 2012) at 4
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`IPR2021-00971, POR at 60-62; Ex. 1006 (Li 2012) at 2
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`57
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`’731 Patent: “Machine Learning” Not Obvious
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00971, POR at 60-62; Ex. 1006 (Li 2012) at 2
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`58
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`
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`’731 Patent: “Machine Learning” Not Obvious
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`• Li 2012: removing ABP data from machine learning reduces FA suppression.
`
`IPR2021-00971, POR at 60-62; Ex. 1006 (Li 2012) at Table 6, 7
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`59
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`
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`’731 Patent: “Machine Learning” Not Obvious
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`• Li 2012: genetic algorithm not used with PPG data.
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`IPR2021-00971, Sur-Reply at 23; Ex. 1006 (Li 2012) at 2
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`60
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`
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`Shmueli Does Not Render Obvious “Machine Learning”
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`• Apple: Shmueli’s “search correlation” to
`“produce new detection parameters”
`(highlighted in Fig. 7) is machine learning.
`
`IPR2021-00970, POR at 67-68; Ex. 1004 (Shmueli) at 13
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`61
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`
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`Shmueli Does Not Render Obvious “Machine Learning”
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`• Dr. Efimov: Shmueli’s search correlation refers to a rule-based algorithm
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`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
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`IPR2021-00971, Ex. 2016 (Efimov Declaration) at ¶ 105
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`62
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`
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`Shmueli Does Not Render Obvious “Machine Learning”
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`IPR2021-00970, POR at 68; Ex. 2017 (Chaitman Deposition) at 109:20-24
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`63
`
`
`
`Skepticism: “Machine Learning”
`
`• Machine learning is controversial among cardiologists.
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`IPR2021-00971, POR at 65; Ex. 2026 (Topol) at 8
`
`64
`
`
`
`Skepticism: “Machine Learning”
`
`• Apple’s ITC expert:
`
`• Machine learning algorithms are “black
`box entities.”
`
`• “[H]aving clinicians trust such entities
`for clinical decision-making is …
`challenging.”
`
`IPR2021-00970, POR at 65; Ex. 2018 (Stultz Deposition) at 211:9-22
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`65
`
`
`
`Skepticism: “Machine Learning”
`
`IPR2021-00970, POR at 65; Ex. 2016 (Efimov Declaration) at ¶103
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`66
`
`
`
`“Machine Learning”: “Could Have Combined” is Insufficient
`
`• Mere knowledge of a technique is not a motivation to modify an existing solution
`to use that technique:
`
`[T]he Board focused on what a skilled artisan would have been able to do, rather
`than what a skilled artisan would have been motivated to do at the time of the
`invention. See InTouch Techs., Inc. v. VGO Commc'ns, Inc., 751 F.3d 1327, 1352
`(Fed. Cir. 2014) (concluding that a party's expert "succumbed to hindsight bias in
`her obviousness analysis" where such analysis "primarily consisted of
`conclusory references to her belief that one of ordinary skill in the art could
`combine these references, not that they would have been motivated to do so").
`
`Polaris Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1068 (Fed. Cir. 2018) (emphasis in original)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`IPR2021-00971, Sur-Reply at 20
`
`67
`
`
`
`“Machine Learning” Is Not Functional Language
`
`• Apple: machine learning is “generic functional language that adds no inventive
`concept.”
`
`"Paresthesia-free" is a functional term, defined by what it does rather than what it is. But that
`does not inherently render it indefinite. See Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d
`1244, 1255 (Fed. Cir. 2008). In fact, we have held that functional language can "promote[]
`definiteness because it helps bound the scope of the claims by specifying the operations that the
`[claimed invention] must undertake." Cox Commc'ns, 838 F.3d at 1232. When a claim
`limitation is defined in "purely functional terms," a determination of whether the limitation
`is sufficiently definite is "highly dependent on context (e.g., the disclosure in the
`specification and the knowledge of a person of ordinary skill in the relevant art area)."
`Halliburton, 514 F.3d at 1255. We have held that the ambiguity inherent in functional terms may
`be resolved where the patent "provides a general guideline and examples sufficient to enable a
`person of ordinary skill in the art to determine the scope of the claims." Enzo Biochem. Inc. v.
`Applera Corp., 599 F.3d 1325, 1335 (Fed. Cir. 2010).
`
`Nevro Corp. v. Boston Scientific Corp., 955 F.3d 35, 39 (Fed. Cir. 2020)
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`IPR2021-00971, Sur-Reply at 19
`
`68
`
`
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