`Apple Inc. v. Omni MedSci, Inc.
`Petitioner Apple’s Demonstrative Exhibit
`Hearing Date: May 5, 2022
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`1
`
`
`
`Grounds
`
`Claims Challenged References
`1, 7, 15, 17
`Lisogurski, Carlson
`1-4, 7-12, 15-22
`Lisogurski, Carlson, Tran
`5, 13
`Lisogurski, Carlson, Tran, Isaacson
`6, 14, 23
`Lisogurski, Carlson, Tran, Isaacson, Valencell-
`093
`
`Reference
`Lisogurski
`Carlson
`Tran
`Isaacson
`Valencell-093
`
`Date
`May 31, 2012
`U.S. 9,241,676
`U.S. 2005/0049468 Mar. 3, 2005
`U.S. 8,108,036
`May 24, 2006
`U.S. 8,725,226
`Nov. 13, 2009
`U.S. 2012/0197093
`Jan. 25, 2012
`
`Exhibit
`1011
`1009
`1064
`1063
`1005
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`2
`
`
`
`Issues
`
`• Ground 1: Lisogurski + Carlson teach increasing SNR by
`increasing pulse rate
`- Lisogurski’s sampling rate feature
`- Lisogurski’s cardiac cycle modulation
`- Lisogurski and Carlson together
`• Ground 2: Lisogurski, Carlson, Tran
`- identify/detect an object (claims 3, 8, 16)
`• Ground 3: Lisogurski, Carlson, Tran, Isaacson
`• Ground 4: Lisogurski, Carlson, Tran, Isaacson, Valencell
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`3
`
`
`
`’484 Patent: Claim 1
`Only one limitation is disputed
`
`1. A system for measuring one or more physiological parameters and for use with a smart phone or tablet, the
`system comprising:
`a wearable device adapted to be placed on a wrist or an ear of a user, including a light source comprising a plurality of
`semiconductor sources that are light emitting diodes, each of the light emitting diodes configured to generate an output optical
`light having one or more optical wavelengths;
`the wearable device comprising one or more lenses configured to receive a portion of at least one of the output optical
`lights and to direct a lens output light to tissue;
`the wearable device further comprising a detection system configured to receive at least a portion of the lens output light
`reflected from the tissue and to generate an output signal having a signal-to-noise ratio, wherein the detection system is
`configured to be synchronized to the light source;
`wherein the detection system comprises a plurality of spatially separated detectors, and wherein at least one analog to
`digital converter is coupled to at least one of the spatially separated detectors;
`wherein a detector output from the at least one of the plurality of spatially separated detectors is coupled to an amplifier
`having a gain configured to improve detection sensitivity;
`the smart phone or tablet comprising a wireless receiver, a wireless transmitter, a display, a speaker, a voice input module,
`one or more buttons or knobs, a microprocessor and a touch screen, the smart phone or tablet configured to receive and process
`{{
`at least a portion of the output signal, wherein the smart phone or tablet is configured to store and display the processed output
`signal, and wherein at least a portion of the processed output signal is configured to be transmitted over a wireless transmission
`link;
`
`a cloud configured to receive over the wireless transmission link an output status comprising the at least a portion of the
`processed output signal, to process the received output status to generate processed data, and to store the processed data;
`wherein the output signal is indicative of one or more of the physiological parameters, and the cloud is configured to store
`a history of at least a portion of the one or more physiological parameters over a specified period of time;
`the wearable device configured to increase the signal-to noise ratio by increasing light intensity of at least one of the
`plurality of semiconductor sources from an initial light intensity and by increasing a pulse rate of at least one of the plurality
`of semiconductor sources from an initial pulse rate; and
`the detection system further configured to:
`generate a first signal responsive to light received while the light emitting diodes are off,
`generate a second signal responsive to light received while at least one of the light emitting diodes is on, and
`increase the signal-to-noise ratio by comparing the first signal and the second signal.
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`4
`
`
`
`’484 Patent: Claim 1
`Only one limitation is disputed
`
`1. A system for measuring one or more physiological parameters and for use with a smart phone or tablet, the
`system comprising:
`a wearable device adapted to be placed on a wrist or an ear of a user, including a light source comprising a plurality of
`semiconductor sources that are light emitting diodes, each of the light emitting diodes configured to generate an output optical
`light having one or more optical wavelengths;
`the wearable device comprising one or more lenses configured to receive a portion of at least one of the output optical
`lights and to direct a lens output light to tissue;
`the wearable device further comprising a detection system configured to receive at least a portion of the lens output light
`reflected from the tissue and to generate an output signal having a signal-to-noise ratio, wherein the detection system is
`configured to be synchronized to the light source;
`wherein the detection system comprises a plurality of spatially separated detectors, and wherein at least one analog to
`digital converter is coupled to at least one of the spatially separated detectors;
`wherein a detector output from the at least one of the plurality of spatially separated detectors is coupled to an amplifier
`having a gain configured to improve detection sensitivity;
`the wearable device configured to increase the signal-to noise ratio by
`the smart phone or tablet comprising a wireless receiver, a wireless transmitter, a display, a speaker, a voice input module,
`one or more buttons or knobs, a microprocessor and a touch screen, the smart phone or tablet configured to receive and process
`{{
`increasing light intensity of at least one of the plurality of semiconductor sources from
`{{
`at least a portion of the output signal, wherein the smart phone or tablet is configured to store and display the processed output
`an initial light intensity and by increasing a pulse rate of at least one of the plurality
`signal, and wherein at least a portion of the processed output signal is configured to be transmitted over a wireless transmission
`link;
`of semiconductor sources from an initial pulse rate; and
`a cloud configured to receive over the wireless transmission link an output status comprising the at least a portion of the
`processed output signal, to process the received output status to generate processed data, and to store the processed data;
`wherein the output signal is indicative of one or more of the physiological parameters, and the cloud is configured to store
`a history of at least a portion of the one or more physiological parameters over a specified period of time;
`the wearable device configured to increase the signal-to noise ratio by increasing light intensity of at least one of the
`plurality of semiconductor sources from an initial light intensity and by increasing a pulse rate of at least one of the plurality
`of semiconductor sources from an initial pulse rate; and
`the detection system further configured to:
`generate a first signal responsive to light received while the light emitting diodes are off,
`generate a second signal responsive to light received while at least one of the light emitting diodes is on, and
`increase the signal-to-noise ratio by comparing the first signal and the second signal.
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`5
`
`
`
`Lisogurski’s Sampling Rate Embodiments
`
`Petition:
`
`Lisogurski also describes embodiments where the firing rate of an
`LED is correlated to the sampling rate of an analog-to-digital converter.
`Ex.1011, 33:47-49 (“sampling rate modulation may be correlated with
`{{
`light drive signal modulation”); see also id., 2:1-2, 27:44-52 (LED
`firing rate can be modulated), 35:25-31.
`Pet. at 35; Ex. 1003 (Anthony Decl.) at ¶178; Reply at 4
`
`Lisogurski:
`
`{{
`
`Ex. 1011 (Lisogurski) at 33:47-52; Pet. at 35, 49; Reply at 15
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`6
`
`
`
`Sampling Rate Is Used in Drive Cycle Modulation
`
`Ex. 1011 (Lisogurksi) at 34:10-13; Reply at 4, 5
`
`For example, an “on” period may be “on” period 202 of FIG. 2A.
`Ex. 1011 (Lisogurksi) at 35:10-13; Reply at 5, 15
`For example, the time between “on” periods may be the length of “off”
`period 220 of FIG. 2A.
`
`Ex. 1011 (Lisogurksi) at 35:24-31; Pet. at 35, 49; Reply at 15
`drive cycle
`modulation
`
`“on” period
`
`Ex. 1011 (Lisogurksi) at Fig. 2A
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`7
`
`
`
`Sampling Rate Is Used in Drive Cycle Modulation
`
`Ex. 1011 (Lisogurksi) at 34:10-13; Reply at 4, 5
`
`For example, an “on” period may be “on” period 202 of FIG. 2A.
`Ex. 1011 (Lisogurksi) at 35:10-13; Reply at 5, 15
`For example, the time between “on” periods may be the length of “off”
`period 220 of FIG. 2A.
`
`Ex. 1011 (Lisogurksi) at 35:24-31; Pet. at 35, 49; Reply at 15
`
`“off” period
`
`drive cycle
`modulation
`
`Ex. 1011 (Lisogurksi) at Fig. 2A
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`8
`
`
`
`Sampling Rate Can Represent Emitter Firing Rate
`
`Ex. 1011 (Lisogurksi) at 34:10-13; Reply at 4, 5
`
`Increasing the duration of the “off” periods (i.e., decreasing the emitter
`firing rate) relates to a decreased sampling rate. Similarly, decreasing
`the duration of the “off” periods (i.e., increasing the emitter firing rate)
`relates to an increased sampling rate.
`Ex. 1011 (Lisogurksi) at 35:24-31; Pet. at 35, 49; Reply at 15
`
`“off” period
`
`drive cycle
`modulation
`
`Ex. 1011 (Lisogurksi) at Fig. 2A
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`9
`
`
`
`Lisogurski’s Modulation Techniques
`
`cardiac cycle
`modulation
`
`drive cycle
`modulation
`
`Ex. 1011 (Lisogurksi) at Fig. 2C; Inst. Dec. at 19-20
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`10
`
`
`
`Lisogurski Describes Varying Firing Rate Outside of CCM
`
`Systems and methods are provided for optimizing power consumption
`in an optical physiological monitoring system. The system may vary
`light drive signal parameters… Parameters that may be varied include
`light intensity, firing rate, duty cycle, other suitable parameters, or any
`combination thereof.
`
`Ex. 1011 (Lisogurksi) at 1:10-12 and 1:20-22; Pet. at 27-28; Reply at 5-6, 14
`
`In some embodiments, sampling rate modulation may be correlated
`with light drive signal modulation.
`
`Ex. 1011 (Lisogurksi) at 33:47-49; Pet. at 35, 49
`
`In some embodiments, the system may vary the sampling rate to
`reduce or optimize power consumption... Varying the sampling rate
`may reduce power consumption by reducing emitter drive time and
`lowering utilization of an analog-to-digital converter.
`
`Ex. 1011 (Lisogurksi) at 33:46-52; Pet. at 35, 49; Reply at 5, 15
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`11
`
`
`
`Lisogurski Describes Varying Firing Rate Outside of CCM
`
`Apple’s Expert:
`Although Lisogurski describes how varying the light drive
`parameters increases the signal-to-noise ratio in the context of
`cardiac cycle modulation, the same principle applies to all the
`{{
`modulation processes, including drive cycle modulation and the
`servo algorithms. Lisogurski also explains that all three types of
`modulation may be used.
`
`Ex. 1003 (Anthony Decl.) at ¶166; Pet. at 48; Reply at 15
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`12
`
`
`
`Increasing Sampling Rate Increases SNR
`
`Lisogurski:
`
`Ex. 1011 (Lisogurksi) at 33:56-58; Pet. at 49
`
`Apple’s Expert Dr. Anthony:
`A person of ordinary skill in the art… would have
`180…
`recognized that increased firing and sampling rates typically improves
`signal to noise because the additional firing and sampling creates more
`signal, and allows for additional measurements, and therefor increases the
`amount of information relative to the noise. It was understood that
`{{
`increasing the firing rate of an LED would typically increase the signal-to-
`noise ratio of the detected signal. Accordingly, a person of ordinary skill in
`the art would have thus understood that Lisogurski’s device increases its
`detected signal-to-noise ratio as both the firing and sampling rate increase.
`Ex. 1003 (Anthony Decl.) at ¶180; Pet. at 49-50; Reply at 4
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`13
`
`
`
`Omni’s Expert: Lisogurski Increases an LED’s Pulse Rate and Doing so
`Generally Increases SNR
`
`{{
`
`Ex. 1060 (MacFarlane Depo) at 59:1-5; Reply at 3, 13
`
`{{
`
`Ex. 1060 (MacFarlane Depo.) at 39:12-17; Reply at 4
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`14
`
`
`
`Omni’s Expert: Increasing an LED’s Pulse Rate Generally Increases SNR
`
`{{
`
`Ex. 1060 (MacFarlane Depo.) at 37:13-38:3; Reply at 7
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`15
`
`
`
`Issues
`
`• Ground 1: Lisogurski + Carlson teach increasing SNR by
`increasing pulse rate
`- Lisogurski’s sampling rate feature
`- Lisogurski’s cardiac cycle modulation
`- Lisogurski and Carlson together
`• Ground 2: Lisogurski, Carlson, Tran
`- identify/detect an object (claims 3, 8, 16)
`• Ground 3: Lisogurski, Carlson, Tran, Isaacson
`• Ground 4: Lisogurski, Carlson, Tran, Isaacson, Valencell
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`16
`
`
`
`Lisogurski’s Cardiac Cycle Modulation
`
`Lisogurski:
`
`Ex. 1011 (Lisogurksi) at 25:49-55; Pet. at 45; Reply at 6
`
`Dr. Anthony (Apple’s Expert):
`182.
`A person of ordinary skill in the art… would have
`recognized the device will increase it firing rate whenever a patient
`subject’s heart rate increases. Thus, Lisogurki’s device will increase
`its pulse rate to remain synchronous with a subject’s heart rate
`{{
`resulting in an increased signal-to-noise ratio being detected. This
`also shows Lisogurki’s device is capable of increasing its SNR by
`increasing its pulse rate, which satisfies PTAB’s construction.
`Ex. 1003 (Anthony Decl.) at ¶182; Pet. at 50; Reply at 6, 9
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`17
`
`
`
`Omni Previously Admitted Lisogurski’s Cardiac Cycle Modulation
`Increases SNR
`
`Omni in its IPR2020-00175 Response:
`
`Lisogurski does not teach or suggest that increasing firing rate
`improves SNR; it merely teaches that heart rate tracking may
`{{
`improve SNR (whether the firing rate increases, decreases or stays
`the same).
`
`-175 Resp. at 13
`
`Omni in its IPR2020-00175 Preliminary Response:
`Lisogurski teaches three different techniques for improving SNR:
`(i) by increasing the “brightness” of the light source, (ii) by operating
`in a “high power mode without cardiac cycle modulation,” and (iii) by
`{{
`modulating the light signal to correlate with “physiological pulses”
`such as a “cardiac pulse,” e.g., “diastole period cardiac modulation” or
`“systole period cardiac cycle modulation.”
`
`-175 Prelim. Resp. at 16
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`18
`
`
`
`The Board Previously Found that Lisogurski’s Cardiac Cycle
`Modulation is Configured to Increase Pulse Rate and Increases SNR
`
`IPR2020-00175 Final Written Decision:
`
`Lisogurski teaches… increasing LED pulse rate to match an
`increased cardiac cycle rate… Patent Owner acknowledges that
`Lisogurski teaches signal-to-noise can be improved by correlating
`{{
`the LED drive signal with a cardiac cycle signal… Lisogurski’s
`system, therefore, is “configured” to increase signal-to-noise by
`increasing LED pulse rate, even if it only does so some of the time.
`-175 FWD at 34-35, Reply at 8-9
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`19
`
`
`
`The Board Previously Found that Lisogurski’s Cardiac Cycle
`Modulation Increases Firing Rate to Increase SNR
`IPR2019-00916 Final Written Decision:
`
`For example, Lisogurski teaches that noise contributes
`“variations of 2.6%, 1.9%, and 3.8% to the computed pulse
`amplitudes of PPG5 signal 2602, systole period modulated PPG
`signal 2604, and diastole period modulated PPG signal 2606.” Ex.
`{{
`1011, 42:50–54. Thus, increasing the LED firing rate to become
`synchronous with the systole period of an increased cardiac cycle
`rate can result in a physiological measurement having less noise
`(1.9%), and, therefore, an increased signal-to-noise ratio.
`
`-916 FWD at 29
`
`Lisogurski:
`
`{{
`
`Ex. 1011 (Lisogurski) at 42:50-54; Pet. at 51; Reply at 6
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`20
`
`
`
`Omni’s Arguments Contradict Federal Circuit Case Law
`
`Omni in its Response:
`
`…Apple argues, “A skilled person would have recognized that this
`[CCM’s ability to vary the firing rate] means, for example, that firing
`rate will increase whenever a subject’s heart rate increases.” (Pet. 50.)
`But such firing rate increases do not affect SNR—they merely maintain
`{{
`existing CCM synchronization. Lisogurski’s claimed SNR benefits occur
`because the LED fires synchronously with the heartbeat… As Apple
`recognizes, CCM increases the LED firing rate only if the heart rate
`increases.
`
`Resp. at 19-20
`
`“It is well settled that an [apparatus] that ‘that sometimes,
`but not always, embodies a claim[] nonetheless’” satisfies
`the claim.
`Broadcom Corp. v. Emulex Corp., 732 F.3d 1325, 1333 (Fed. Cir. 2013).
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`21
`
`
`
`Firing Rate Changes During Cardiac Cycle Modulation Increase SNR
`By Reducing Gaussian Noise
`
`Lisogurski:
`
`{{
`
`Ex. 1011 (Lisogurski) at 41:46-52; Reply at 8
`
`Petitioner’s Reply:
`
`But Lisogurski provides that CCM does increase SNR and that it does
`{{
`so in the presence of Gaussian noise of 0-5 Hz.
`
`Reply at 8
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`22
`
`
`
`Carlson’s Noise Distribution
`
`Ex. 1009 (Carlson) at Fig. 7b; Inst. Dec. at 50
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`23
`
`
`
`Omni’s Expert’s Noise
`
`Ex. 2136 (MacFarlane Decl.) at ¶ 83; Resp. at 23
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`24
`
`
`
`Issues
`
`• Ground 1: Lisogurski + Carlson teach increasing SNR by
`increasing pulse rate
`- Lisogurski’s sampling rate feature
`- Lisogurski’s cardiac cycle modulation
`- Lisogurski and Carlson together
`• Ground 2: Lisogurski, Carlson, Tran
`- identify/detect an object (claims 3, 8, 16)
`• Ground 3: Lisogurski, Carlson, Tran, Isaacson
`• Ground 4: Lisogurski, Carlson, Tran, Isaacson, Valencell
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`25
`
`
`
`Lisogurski Can Change Modulation Parameters Based on Noise
`
`Ex. 1011 (Lisogurksi) at 9:46-57; Pet. at 53; Reply at 17
`
`In some embodiments, the system may detect a condition
`where a second mode is required that is not related to a
`physiological condition. For example, the system may detect a
`change in background noise, a change in ambient light…, [or] other
`suitable changes…
`…[I]n a second mode[,] [f]or example, the system may stop cardiac
`cycle modulation and emit light at a constant brightness… In a
`further example, the system may alter the cardiac cycle modulation
`technique as described above with relation to FIG. 8B.
`Ex. 1011 (Lisogurksi) at 37:6-22; Pet. at 48
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`26
`
`
`
`Carlson Describes Techniques to Increase SNR
`in Dynamic Environments
`
`Ex. 1009 (Carlson) at ¶ [0007]; Reply at 10
`
`Ex. 1009 (Carlson) at ¶ [0010]; Pet. at 24-25
`
`Ex. 1009 (Carlson) at ¶ [0068]; Pet. at 52
`Petitioner Apple Inc. – Ex. 1067
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`
`27
`
`
`
`Carlson Teaches Shifting to Higher Pulse Rates
`
`* * *
`
`Ex. 1009 (Carlson) at ¶ [0069]; Pet. at 52-53
`
`Ex. 1009 (Carlson) at Claim 10; Reply at 11
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`28
`
`
`
`Carlson Teaches Increasing Pulse Rate to a
`Higher Frequency to Increase SNR
`
`Ex. 1009 (Carlson) at ¶ [0020]; Reply at 10-11
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`29
`
`
`
`Lisogurski:
`
`Carlson:
`
`Lisogurski and Carlson Teach Claim 1
`
`In some embodiments, the system may detect a condition
`where a second mode is required that is not related to a
`physiological condition. For example, the system may detect a
`change in background noise, a change in ambient light…, [or]
`other suitable changes…
`In step 1906, the system may perform a physiological
`measurement in a second mode. For example, the system may
`stop cardiac cycle modulation and emit light at a constant
`brightness… In a further example, the system may alter the
`cardiac cycle modulation technique as described above with
`relation to FIG. 8B.
`
`Ex. 1011 (Lisogurksi) at 37:6-22; Pet. at 48-49
`
`[0069]… The frequency is chosen in such a way that it is outside
`the frequency spectrum of sunlight and of ambient light which,
`according to FIG. 7b, is in the range of above approximately
`1000 Hz… Fo could be e.g., as mentioned 1000 Hz which of
`course is a frequency far outside of any indoor light source…
`fo of course can be chosen at any other frequency, as e.g. 2000 Hz
`or even higher.
`
`Ex. 1009 (Carlson) at ¶ [0069]; Pet. at 52-53
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`30
`
`
`
`The Board Previously Found that Lisogurski’s Second Mode Can
`Increase LED Firing Rate
`
`IPR2020-00175 Final Written Decision:
`The second mode, for example, can (a) “stop cardiac cycle
`modulation,” (b) “increase emitter intensity” during cardiac cycle
`modulation, (c) “lengthen the ‘on’ periods” (i.e., duty cycle) of
`{{
`cardiac cycle modulation, or (d) “alter the cardiac cycle modulation”
`by changing the LED firing rate as shown in Figure 8B.
`-175 FWD at 39; Pet. at 49; Reply at 16-17
`
`Petitioner Apple Inc. – Ex. 1067
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`
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`The Board Previously Found that Carlson Suggests Configuring
`Lisogurski to Increase Pulse Rate to Increase SNR
`
`IPR2020-00175 Final Written Decision:
`
`Lisogurski teaches[:]
`(1) modulating an LED by pulsing it at a 1 Hz rate that matches a
`cardiac cycle,
`(2) detecting ambient light noise, and
`(3) changing the LED modulation to operate in a second mode by
`{{
`changing one or more of the LED brightness, duty cycle (on
`time per cycle), or firing rate,
`and Carlson teaches[:]
`(4) various means to improve a pulsoximeter’s signal-to-noise
`ratio.
`
`-175 FWD at 39-40
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`
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`Omni Incorrectly Argues that Carlson Changes CCM’s
`Principle of Operation
`
`Omni in its Response:
`Apple’s proposal to “increase the LED firing rate” of Lisogurski “as
`taught by Carlson,” requires increasing the CCM firing rate to 1000
`{{
`Hz or more… This is not a viable obviousness combination because
`it changes CCM’s principle of operation.
`
`Resp. at 28
`
`Lisogurski:
`It will be understood that the system may apply this cardiac cycle
`modulation to the light drive signal in addition to a drive cycle
`{{
`modulation, as illustrated in FIG. 2C, and conventional servo algorithms.
`Ex. 1011 (Lisogurski) at 25:58-65; Reply at 2, 6, 16
`
`For example, cardiac cycle modulation may be an envelope on the order
`{{
`of 1 Hz super-imposed on a 1 kHz sine wave drive cycle modulation.
`Ex. 1011 (Lisogurski) at 6:29-31; Reply at 2, 6
`
`It will be understood that cardiac cycle modulation techniques, while
`generally related to the cardiac cycle, may not necessarily be precisely
`correlated to the cardiac cycle and may be related to… external triggers
`(e.g., respiration), user input, [or] other suitable techniques…
`Ex. 1011 (Lisogurksi) at 5:41-47; Reply at 17
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`33
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`
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`Issues
`
`• Ground 1: Lisogurski + Carlson teach increasing SNR by
`increasing pulse rate
`- Lisogurski’s sampling rate feature
`- Lisogurski’s cardiac cycle modulation
`- Lisogurski and Carlson together
`• Ground 2: Lisogurski, Carlson, Tran
`- identify/detect an object (claims 3, 8, 16)
`• Ground 3: Lisogurski, Carlson, Tran, Isaacson
`• Ground 4: Lisogurski, Carlson, Tran, Isaacson, Valencell
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`34
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`
`
`Claims 3, 8, and 16
`
`3. The system of claim 2, wherein the wearable device is at least in
`part configured to identify an object, and to compare a property of at least
`{{
`some of the output signal to a threshold.
`
`‘484 Patent at Claim 3
`
`8. The system of claim 7, wherein the wearable device is at least in
`part configured to identify an object, and a property of at least some of the
`{{
`output signal is compared by at least one of the wearable device, the smart
`phone or tablet to a threshold.
`
`‘484 Patent at Claim 8
`
`16. The system of claim 15, wherein the wearable device is at least in
`part configured to detect an object, and a property of at least some of the
`{{
`output signal is compared to a threshold.
`
`‘484 Patent at Claim 16
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`35
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`
`
`“Detect” and “Identify” Should be Construed According to their
`Plain and Ordinary Meanings
`Apple
`Plain and ordinary meaning
`
`Term
`to detect an object
`
`to identify an object
`
`Otherwise, to discover or determine the
`existence, presence, or fact of an object
`Plain and ordinary meaning
`
`Otherwise, to discover or determine the
`existence, presence, or fact of an object
`
`Omni
`To discover or notice the
`existence or presence of
`
`To recognize or establish as
`being a particular person or
`thing
`
`3. The system of claim 2, wherein the wearable device is at least in
`part configured to identify an object, and to compare a property of at least
`{{
`some of the output signal to a threshold.
`
`‘484 Patent at Claim 3
`
`16. The system of claim 15, wherein the wearable device is at least in
`part configured to detect an object, and a property of at least some of the
`{{
`output signal is compared to a threshold.
`
`‘484 Patent at Claim 16
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`36
`
`
`
`“Detect” and “Identify” Should be Construed According to their
`Plain and Ordinary Meanings
`Apple
`Plain and ordinary meaning
`
`Term
`to detect an object
`
`to identify an object
`
`Otherwise, to discover or determine the
`existence, presence, or fact of an object
`Plain and ordinary meaning
`
`Otherwise, to discover or determine the
`existence, presence, or fact of an object
`
`Omni
`To discover or notice the
`existence or presence of
`
`To recognize or establish as
`being a particular person or
`thing
`
`3. The system of claim 2, wherein the wearable device is at least in
`part configured to identify an object, and to compare a property of at least
`{{
`some of the output signal to a threshold.
`
`‘484 Patent at Claim 3
`
`’484 Patent Specification:
`
`{{
`
`’484 Patent at 17:12-13; Reply at 20
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`37
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`
`
`Lisogurski Discloses “Detecting” and “Identifying” an Object
`
`Petition:
`
`Lisogurski teaches that its sensor can detect when it has fallen off. Ex.1011,
`36:66-37:2 (“the system may detect a signal indicative of a system error such as… a
`{{
`probe-off signal”). Thus, Lisogurski’s sensor can identify when an object (e.g., a wrist
`or an ear) is in range of the sensor (“the wearable device is at least in part configured
`to identify an object”).
`Pet. at 62; Reply at 22
`
`Lisogurski:
`In step 1904, the system may detect a physiological condition… In some
`embodiments, the system may detect a physiological parameter, for example, a low
`blood oxygen saturation, low pulse rate, high pulse rate, high blood pressure… In
`some embodiments, the system may detect a signal indicative of a system error such as
`{{
`a physiologically impossible value, a probe-off signal, any other suitable signal, or any
`combination thereof. The system may detect the physiological condition using
`information obtained through measurements in step 1902, from an external sensor or
`controller, by any other suitable technique, or any combination thereof.
`Ex. 1011, 36:54-37:5; Pet., 62; Reply at 22-23
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
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`38
`
`
`
`Lisogurski “Identif[ies] an Object” Under Omni’s Construction
`
`’484 Patent Specification:
`In addition, it may be advantageous to use pattern matching algorithms and other
`{{
`software and mathematical methods to identify the blood constituents of interest.
`Ex. 1001 (‘484 Patent) at 12:57-60; Resp. at 13
`
`Lisogurski:
`In step 1904…, the system may detect a physiological parameter, for
`{{
`example, a low blood oxygen saturation, low pulse rate, high pulse rate…
`Ex. 1011 (Lisogurski), 36:54-65; Pet. at 58, 63; Reply at 22, 24
`
`The light intensity or the amount of light absorbed may then be used to calculate
`any of a number of physiological parameters, including an amount of a blood
`{{
`constituent (e.g., oxyhemoglobin) being measured as well as a pulse rate and
`when each individual pulse occurs.
`
`Ex. 1011 (Lisogurski), 4:36-41; Reply at 24
`
`[H]ighly oxygenated blood will absorb relatively less red light and more IR light
`than blood with a lower oxygen saturation. By comparing the intensities of two
`{{
`wavelengths at different points in the pulse cycle, it is possible to estimate the
`blood oxygen saturation of hemoglobin in arterial blood.
`Ex. 1011 (Lisogurski), 4:45-51; Reply at 24
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`39
`
`
`
`Lisogurski “Identif[ies] an Object” Under Omni’s Construction
`
`’484 Patent Specification:
`In addition, it may be advantageous to use pattern matching algorithms and other
`{{
`software and mathematical methods to identify the blood constituents of interest.
`Ex. 1001 (‘484 Patent) at 12:57-60; Resp. at 13
`
`Petition:
`
`Lisogurski teaches that its sensor can detect when it has fallen off. Ex.1011,
`36:66-37:2 (“the system may detect a signal indicative of a system error such as… a
`probe-off signal”). Thus, Lisogurski’s sensor can identify when an object (e.g., a wrist
`or an ear) is in range of the sensor (“the wearable device is at least in part configured
`to identify an object”). Ex.1003, ¶221.
`{{
`Lisogurski discloses comparing the detected signals to a variety of thresholds.
`Ex.1003, ¶222. For example, Lisogurski states that “the blood oxygen saturation may
`be compared to a threshold or target value, such as threshold 830,” Ex.1011, 24:41-43,
`and the outcome may be used to change the device’s mode of operation, Ex.1011,
`24:43-57.
`
`Pet. at 62-63
`
`Petitioner Apple Inc. – Ex. 1067
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2021-00453
`
`40
`
`
`
`Omn