`Apple Inc. v. Omni MedSci, Inc.
`Petitioner Apple’s Demonstrative Exhibit
`March 25, 2021
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`1
`
`
`
`Grounds
`
`Claims Challenged References
`7, 11-13
`Lisogurski, Carlson
`12, 13
`Lisogurski, Carlson, Mannheimer
`10, 14
`Lisogurski, Carlson, Park
`14
`Lisogurski, Carlson, Park, Mannheimer
`
`Reference
`Lisogurski
`Carlson
`Mannheimer
`Park
`
`Date
`May 31, 2012
`U.S. 9,241,676
`U.S. 2005/0049468 Mar. 3, 2005
`U.S. 5,746,206
`May 5, 1998
`U.S. 9,596,990
`Nov. 6, 2013
`
`Exhibit
`1011
`1009
`1008
`1010
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`2
`
`
`
`’299 Patent: Claim 7
`Only one limitation is disputed
`7. A system for measuring one or more physiological parameters comprising:
`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 beam having one or more optical wavelengths, wherein at
`least a portion of the one or more optical wavelengths is a near-infrared wavelength between 700 nanometers and
`2500 nanometers;
`a lens configured to receive a portion of at least one of the output optical beams and to deliver a lens output
`beam to tissue;
`a detection system configured to receive at least a portion of the lens output beam 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;
`a personal device comprising a wireless receiver, a wireless transmitter, a display, a microphone, a speaker,
`one or more buttons or knobs, a microprocessor and a touch screen, the personal device configured to receive and
`process at least a portion of the output signal, wherein the personal device 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 remote device 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 remote device
`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 system 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 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 differencing the first signal and the second signal.
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`3
`
`
`
`Lisogurski’s System
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`4
`
`
`
`Lisogurski’s Cardiac Cycle Modulation Can Increase Firing Rate
`
`Ex. 1011 (Lisogurksi) at 25:49-55; Pet. at 48; Reply at 7
`
`0
`
`Ex. 1011 (Lisogurksi) at 35:28-31; Pet. at 48-49; Reply at 6-7
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`5
`
`
`
`Lisogurski Can Change Cardiac Cycle Modulation Based on Noise
`
`Ex. 1011 (Lisogurksi) at 9:46-57; Pet. at 48
`
`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
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`6
`
`
`
`Lisogurski Changes Modulation Parameters to Increase SNR
`
`Ex. 1011 (Lisogurksi) at 9:46-57; Pet. at 48
`
`In some embodiments, physiological pulses may be cardiac
`pulses, respiratory pulses, muscular pulses, any other suitable
`pulses, or any combination thereof… In some embodiments,
`particular segments of a respiratory cycle may provide an
`increased signal to noise ratio… In some embodiments,
`respiration may cause variations in photoplethysmography data,
`and thus it may be desired to correlate a modulation technique
`with respiration variations or both respiration variations and
`cardiac pulses.
`
`Ex. 1011 (Lisogurksi) at 25:66-26:14; Reply at 8; Inst. Dec. at 46
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`7
`
`
`
`Omni Admits Lisogurski’s Cardiac Cycle Modulation Increases SNR
`
`Omni in its Sur-Reply:
`
`Apple has no evidence that CCM’s tiny increases in LED
`{{
`firing rate (to match changing cardiac signals) increases SNR.
`Sur-Reply at 2
`
`Omni in its 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).
`
`Resp. at 13
`
`Omni in its 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.”
`
`Prelim. Resp. at 16
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`8
`
`
`
`Omni’s Arguments Contradict Federal Circuit Case Law
`
`Omni in its Response:
`
`Varying the LED firing rate to remain synchronous with the
`selected point of a person’s cardiac cycle to track the heart rate will
`both decrease and increase the firing rate… 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).
`
`Resp. at 13
`
`“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. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`9
`
`
`
`Omni’s Expert: Lisogurski Increases an LED’s Pulse Rate and Doing so
`Generally Increases SNR
`
`Ex. 1065 (MacFarlane Depo) at 59:1-5; Reply at 7
`
`{{
`
`{{
`
`Ex. 1065 (Mac Farlane Depo.) at 39:12-17; Reply at 4-5
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`10
`
`
`
`Omni’s Expert: Increasing an LED’s Pulse Rate Generally Increases SNR
`
`{{
`
`Ex. 1065 (Mac Farlane Depo.) at 37:13-38:3; Reply at 5
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`11
`
`
`
`The Board Previously Found that Lisogurski’s Cardiac Cycle
`Modulation Increases Pulse Rate and Increases 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
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`12
`
`
`
`Apple’s Expert: Increasing Lisogurski’s Firing Rate Increases SNR
`
`Ex. 1011 (Lisogurksi) at 33:56-58; Pet. at 49
`
`Ex. 1011 (Lisogurksi) at 35:25-31; Pet. at 49; Reply at 7
`
`{{
`
`Ex. 1003 (Anthony Decl.) at ¶156; Pet. at 49
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`13
`
`
`
`Lisogurski and Carlson Teach All the Elements of Claim 7
`
`Petitioner’s Reply:
`Lisogurski teaches a device that is configured to (i) detect
`changes in the noise level, (ii) vary cardiac cycle modulation (e.g.,
`by changing the light drive parameters) in response to changes in the
`{{
`noise, (iii) vary cardiac cycle modulation for the purpose of
`increasing SNR, and (iv) increase LED firing rate (which is one of
`the light drive parameters) in some circumstances.
`
`Reply at 14
`
`The purported missing element is an explicit teaching that pulse
`rate can be increased for the purpose of increasing SNR. But that
`teaching is supplied by Carlson, which shows that the skilled person
`{{
`would have understood that using a higher pulse rate for an LED can
`increase SNR in the presence of noise.
`
`Reply at 21
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`14
`
`
`
`Lisogurski Can Change Cardiac Cycle Modulation Based on Noise
`
`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
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`15
`
`
`
`The Board Previously Found that Lisogurski’s Second Mode Can
`Increase LED Firing Rate
`IPR2019-00916 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.
`
`-916 FWD at 32
`
`Lisogurski:
`
`Ex. 1011 (Lisogurksi) at 9:46-57; Pet. at 48
`
`0
`
`Ex. 1011 (Lisogurksi) at 35:28-31;
`Pet. at 48; Reply at 7
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`16
`
`
`
`Carlson Describes Techniques to Increase SNR
`in Dynamic Environments
`
`Ex. 1009 (Carlson) at ¶ [0070]; Reply at 15
`
`Ex. 1009 (Carlson) at ¶ [0010]; Pet. at 22-23
`
`Ex. 1009 (Carlson) at ¶ [0068]; Pet. at 50-51
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`17
`
`
`
`Carlson Teaches Shifting to Higher Pulse Rates
`
`* * *
`
`Ex. 1009 (Carlson) at ¶ [0069]; Pet. at 50
`
`Ex. 1009 (Carlson) at Claim 10; Reply at 17
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`18
`
`
`
`Carlson Teaches Increasing Pulse Rate to a
`Higher Frequency to Increase SNR
`
`Ex. 1009 (Carlson) at ¶ [0020]; Reply at 15
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`19
`
`
`
`Lisogurski:
`
`Carlson:
`
`Lisogurski and Carlson Teach Claim 7
`
`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
`
`[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 50
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`20
`
`
`
`The Board Previously Found that Carlson Suggests Configuring
`Lisogurski to Increase Pulse Rate to Increase SNR
`
`IPR2019-00916 Final Written Decision:
`
`Lisogurski teaches[:]
`(1) taking a physiological measurement in cardiac cycle
`modulation mode using LEDs modulated at a 1Hz pulse rate,
`(2) exiting the cardiac cycle modulation mode upon detecting
`ambient light noise, and
`{{
`(3) taking the measurement in a second mode that varies any
`combination of LED brightness, duty cycle, or firing rate,
`and Carlson teaches[:]
`(4) taking a physiological measurement using an LED modulated
`at a 1000 Hz pulse rate to reduce ambient light noise.
`-916 FWD at 33-34
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`21
`
`
`
`Lisogurski Can Apply Multiple Modulation Techniques
`
`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… and conventional servo algorithms.
`Ex. 1011 (Lisogurksi) at 25:58-65; Reply at 23
`
`[T]he system may combine cardiac cycle modulation
`techniques… More complex selections, alterations, overlapping,
`and convolving of cardiac cycle modulation techniques may be
`used…
`Ex. 1011 (Lisogurksi) at 7:4-12; Reply at 23
`
`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,
`other suitable techniques, or any combination thereof.
`Ex. 1011 (Lisogurksi) at 5:41-47; Reply at 24
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`22
`
`
`
`Apple’s Expert: a POSA Would Have Modified Lisogurski
`Based on Carlson
`
`{{
`***
`
`Ex. 1003 (Anthony Decl.) at ¶81; Pet. at 22-23
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`23
`
`
`
`The Board Previously Found that a Skilled Person Would Have
`Combined Lisogurski and Carlson
`
`IPR2019-00916 Final Written Decision:
`
`[W]e agree with Petitioner that a person skilled in the art would have
`combined the teachings of Lisogurski and Carlson because the
`references teach “complementary designs and techniques in
`{{
`analogous systems,” including “techniques for achieving the same
`objectives” of increasing signal-to-noise in the presence of
`environmental noise such as ambient light or sunlight.
`
`-916 FWD at 24
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`24
`
`
`
`Carlson Teaches that 0 Hz Is a Pulse Frequency
`
`Ex. 1009 (Carlson) at Fig. 7b; Inst. Dec. at 50
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`25
`
`
`
`Omni’s Alleged Written Description Support
`
`The specification states, “The wearable device is configured to increase the signal-to-
`noise ratio . . . by increasing a pulse rate from an initial pulse rate of at least one of the
`plurality of semiconductor sources.” (Id. at 3:11-16.)
`
`The specification states that “[b]y use of an active illuminator, a number of advantages
`may be achieved” including “higher signal-to-noise ratios.” (Id. at 29:3-4.)
`
`PCT Application Serial No. PCT/US2013/075767 (Publication No. WO/2014/143276),
`which is incorporated by reference into the ’299 specification, describes the use of an
`{{
`“active illuminator” to achieve “higher signal-to-noise ratios” despite “variations due to
`sunlight” and the “effects of the weather, such as clouds and rain.” (Ex. 1001 at 1:32-36;
`Ex. 2120 at 26-27, ¶[0079].)
`
`This is consistent with U.S. Patent Application Serial No. 14/109,007 (Publication No.
`2014/0236021), also incorporated by reference into the ’299 specification, which
`discloses that the modulation frequency of the light source is non-zero and can range
`between “0.1-100kHz.” (Ex. 1001 at 1:39-41; Ex 2121 at 29, ¶[0045].)
`
`Response at 6-7
`
`Petitioner Apple Inc. – Ex. 1066
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE - Apple Inc. V. Omni MedSci, Inc., IPR2020-00175
`
`26
`
`