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`EXHIBIT 9
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`EXHIBIT 9
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`APPLE 1037
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`1
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`08718-00001/12588536.1
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`theories under which Respondent’s products infringe this patent.
`preliminary and AliveCor’s investigation into Respondent’s infringement is ongoing. AliveCor reserves the right to provide additional
`include the Apple Watch Series 6, the Apple Watch Series 5, and the Apple Watch Series 4. The infringement analysis in this chart is
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`1 This chart describes infringement by the Apple Watch Series 6, an exemplary Accused Product. The Accused Products
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`operatively coupled to the processing device. For example, the Apple Watch Series 6 Technical Specifications
`The Accused Products contain ECG sensor, comprising two or more ECG electrodes, the ECG sensor
`https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180042.pdf.
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`more ECG electrodes,
`comprising two or
`an ECG sensor,
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`1.3
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`us/HT204666.
`sensor in Apple Watch uses what is known as photoplethysmography.” https://support.apple.com/en-
`heart sensor.” https://support.apple.com/kb/SP826?locale=en_IN. As Apple Support explains, “The optical heart
`device. For instance. The Apple Watch Series 6 Technical Specifications mention a “third-generation optical
`The Accused Products contain photoplethysmography (“PPG”) sensor operatively coupled to the processing
`https://support.apple.com/kb/SP826?locale=en_IN.
`Package, (SiP), described in Apple’s Technical Specifications.
`The Accused Products contain a processor. For instance, the Apple Watch Series 6 contains the S6 System in
`app.” https://www.apple.com/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf.
`arrhythmias such as atrial fibrillation (AFib): the Irregular Rhythm Notification Feature (IRNF) and the ECG
`states that “Apple Watch customers have access to two software as medical device features to detect heart
`The Accused Products are smartwatches designed to detect arrhythmias. For example, Apple’s documentation
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`Apple Watch
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`irregular notification feature.
`This information is repeated in Apple’s de novo classification request to the FDA for the Apple Watch’s
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`the processing device;
`operatively coupled to
`(“PPG”) sensor
`photoplethysmography
`a
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`a processing device;
`comprising:
`an arrhythmia,
`detect the presence of
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`Claim
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`1.P A smart watch to
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`1.2
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`1.1
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`Exhibit 9: Infringement of U.S. Patent No. 10,595,731 by Apple Watch1
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`2
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`2
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`from the ECG sensor; and confirm the presence of the arrhythmia based on the ECG data.
`PPG data from the PPG sensor; detect, based on the PPG data, the presence of an arrhythmia; receive ECG data
`instructions stored thereon that, when executed by the processing device, cause the processing device to: receive
`The accused products contain a memory, operatively coupled to the processing device, the memory having
`https://support.apple.com/kb/SP826?locale=en_IN.
`and 44mm), and indicate that both are “Always-On Retina LTPO OLED display[s].”
`Watch Series 6 Technical Specifications describe the two screen sizes the Apple Watch Series 6 come in (40mm
`The Accused products contain a display operatively coupled to the processing device. For example, the Apple
`https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf.
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`the instructions that infringe this element.
`https://support.apple.com/kb/SP826?locale=en_IN. Some of this storage is used to run watchOS, which contains
`For example, Apple’s Technical specifications show that the Apple Watch Series 6 contains 32GB of storage.
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`https://support.apple.com/en-us/HT204666.
`Series 6 also have built-in electrodes in the Digital Crown and the back of Apple Watch.”
`Apple’s ECG sensor comprises two electrodes. As Apple Support explains, “Apple Watch Series 4, Series 5, or
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`ECG app.
`This information is also contained in Apple’s de novo classification request to the FDA for the Apple Watch’s
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`The Apple Watch contains two electrodes that comprise the ECG sensor:
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`https://support.apple.com/kb/SP826?locale=en_IN.
`mention a “electrical heart sensor” connected to the “ECG app.”
`Apple Watch
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`08718-00001/12588536.1
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`device to: receive PPG
`cause the processing
`processing device,
`executed by the
`thereon that, when
`instructions stored
`memory having
`processing device, the
`coupled to the
`a memory, operatively
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`processing device;
`coupled to the
`a display operatively
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`1.5
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`1.4
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`the processing device;
`operatively coupled to
`the ECG sensor
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`Claim
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`3
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`3
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`08718-00001/12588536.1
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`1.5, above.
`The Accused Products confirm the presence of the arrhythmia based on the ECG data. See, e.g., Claim Element
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`and 1.5, above.
`The Accused Products receive ECG data from an ECG sensor of the smartwatch. See, e.g., Claim Elements 1.3
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`e.g., Claim Element 1.5, above.
`The Accused Products detect by a processing device, based on the PPG data, the presence of an arrhythmia. See,
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`and 1.5, above.
`The Accused Products receive PPG data from a PPG sensor of the smartwatch. See, e.g., Claims Elements 1.2
`https://www.apple.com/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf.
`Feature (IRNF) and the ECG app.”
`device features to detect heart arrhythmias such as atrial fibrillation (AFib): the Irregular Rhythm Notification
`example, Apple’s documentation states that “Apple Watch customers have access to two software as medical
`The Accused Products perform a method to detect the presence of an arrhythmia of a user on a smart watch. For
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`confirming how the Accused Products use the ECG data to confirm the presence of the arrhythmia. (Id.)
`obtaining the ECG, a proprietary algorithm classifies the ECG tracing as SR, AFib, or inconclusive in ECG 1.0,”
`https://www.apple.com/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf. It also states that “After
`generation and analysis of an ECG similar to a Lead I ECG.”
`Series 4, Series 5, and Series 6 also have an electrical heart sensor that, when using the ECG app, enables the
`irregular pulse suggestive of AFib. In addition to using this PPG-based identification algorithm, Apple Watch
`Apple Watch Series 1 and later are able to use PPG signals combined with an algorithm to identify periods of
`In its documentation about the Apple Watch’s arrhythmia detection, Apple writes “With watchOS 5.1.2 or later,
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`Apple Watch
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`17.P A method to detect the
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`data.
`based on the ECG
`of the arrhythmia
`confirm the presence
`ECG sensor; and
`ECG data from the
`arrhythmia; receive
`presence of an
`on the PPG data, the
`sensor; detect, based
`data from the PPG
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`Claim
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`the smartwatch;
`from a PPG sensor of
`receiving PPG data
`comprising:
`on a smart watch,
`arrhythmia of a user
`presence of an
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`17.3
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`17.1
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`of the smartwatch;
`from an ECG sensor
`receiving ECG data
`an arrhythmia;
`data, the presence of
`based on the PPG
`processing device,
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`presence of the
`confirming the
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`17.4 and
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`17.2 detecting by a
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`4
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`08718-00001/12588536.1
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`https://www.apple.com/healthcare/docs/site/Apple_Watch_Arrhythmia_Detection.pdf.
`algorithm to determine if an irregular rhythm might be present.”
`“If the PPG-based arrhythmia detection is enabled, Apple Watch classifies each tachogram using a proprietary
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`presence of an arrhythmia.
`The Apple Watch also receives ECG data from the ECG sensor and then, based on that data, confirms the
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`From Apple’s documentation on taking an ECG:
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`data.
`ECG data from an ECG sensor of the smartwatch; and confirm the presence of the arrhythmia based on the ECG
`the smartwatch; detect by the processing device, based on the PPG data, the presence of an arrhythmia; receive
`when executed by a processing device, cause the processing device to: receive PPG data from a PPG sensor of
`The Accused Products comprise non-transitory computer-readable storage medium including instructions that,
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`the Apple Watch’s processor. https://support.apple.com/kb/SP826?locale=en_IN.
`computer readable medium, encoded with watchOS, a computer program including instructions executable by
`https://support.apple.com/kb/SP826?locale=en_IN. The Apple Watch Series 6 contains storage, a non-transitory
`For example, Apple’s Technical specifications show that the Apple Watch Series 6 contains 32GB of storage.
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`an arrhythmia.
`The Apple Watch receives PPG data from the PPG sensor and then, based on that data, detects the presence of
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`Apple Watch
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`device to:
`cause the processing
`a processing device,
`that, when executed by
`including instructions
`storage medium
`computer-readable
`A non-transitory
`the ECG data.
`arrhythmia based on
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`Claim
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`data.
`based on the ECG
`of the arrhythmia
`confirm the presence
`smartwatch; and
`ECG sensor of the
`ECG data from an
`an arrhythmia; receive
`data, the presence of
`based on the PPG
`the processing device,
`smartwatch; detect by
`a PPG sensor of the
`receive PPG data from
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`25
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`5
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`5
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`08718-00001/12588536.1
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`https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180042.pdf.
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`novo classification request to the FDA regarding its irregular rhythm notification:
`The ECG data is used to confirm the irregular heartbeat notification generated by PPG data. From Apple’s de
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`https://support.apple.com/en-us/HT208955.
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`Apple Watch
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`Claim
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`6
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