UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`OMNI MEDSCI, INC.,
`Patent Owner.
`
`______________
`
`U.S. Patent No. 10,517,484
`
`IPR Case No.: IPR2021-00453
`
`______________
`
`
`
`PATENT OWNER’S RESPONSE TO PETITION
`FOR INTER PARTES REVIEW UNDER 37 C.F.R. § 42.107
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`
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`Atty. Dkt. No.: OMSC0119IPR1
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`TABLE OF CONTENTS
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`TABLE OF AUTHORITIES ................................................................................ iii
`
`UPDATED LIST OF EXHIBITS ........................................................................... v
`
`I.
`
`II.
`
`Introduction ................................................................................................. 1
`
`Overview of the ‘484 Patent ........................................................................ 4
`
`A.
`
`The ‘484 Patent discloses innovative systems for making
`accurate non-invasive physiological measurements ........................... 4
`
`B.
`
`AIA status and Priority Date .............................................................. 8
`
`III. Claim Construction ...................................................................................... 8
`
`A.
`
`B.
`
`C.
`
`The “pulse rate” limitation (all claims) .............................................. 8
`
`“to identify an object” (Claims 3 and 8) ............................................11
`
`“to detect an object” (Claim 16)........................................................13
`
`IV. The Board should deny the Petition because it fails to establish prima
`facie obviousness of the Challenged Claims ...............................................14
`
`A. Grounds 1 & 2: Apple has failed to show that Lisogurski, alone,
`or combined with Carlson, renders the “pulse rate” limitation
`obvious .............................................................................................14
`
`1.
`
`Lisogurski alone: The changes in LED firing rate during
`Lisogurski’s CCM, which Apple relies on for
`obviousness, undisputedly “have no measurable effect on
`SNR” ......................................................................................15
`
`a)
`
`b)
`
`c)
`
`Apple’s first Lisogurski-alone argument depends
`on CCM ........................................................................16
`
`Apple’s second Lisogurski-alone argument “also”
`depends on CCM ..........................................................17
`
`Apple ignores the undisputed evidence that CCM
`“firing rate” increases do not increase SNR ..................21
`
`2.
`
`Carlson does not disclose “increasing a pulse rate …
`from an initial pulse rate” as the Challenged Claims
`require.....................................................................................24
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`3.
`
`Lisogurski and Carlson: Modifying Lisogurski’s CCM
`“as taught by Carlson” changes CCM’s principle of
`operation .................................................................................26
`
`B.
`
`Ground 2 (Claims 1-4, 7-12, and 15-22): Apple (a) does not
`identify which of its 10 background references provide a
`motivation to combine Tran with Lisogurski and (b) fails to
`provide a motivation to combine all three references ........................33
`
`C.
`
`Ground 2 (Claims 3, 8, and 16): Knowing a sensor is
`disconnected is not detecting, or identifying, an object .....................36
`
`D. Ground 3 (Claims 5 and 13): Apple’s combination of four
`references lacks a motivation to combine all four references ............38
`
`E.
`
`Ground 4 (Claims 6, 14, and 23): Apple’s combination of five
`references lacks a motivation to combine all five references .............40
`
`V.
`
`Conclusion ..................................................................................................43
`
`Certificate of Service ............................................................................................44
`
`Certificate of Compliance Pursuant to 37 C.F.R. § 42.24 ......................................45
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`TABLE OF AUTHORITIES
`
`Cases
`
`In re Fritch,
`
`972 F.2d 1260 (Fed. Cir. 1992) ............................................................. 38, 41
`
`In re Kahn,
`
`441 F.3d 977 (Fed. Cir. 2006) .............................................. 33-34, 37, 39-41
`
`In re Magnum Oil Tools Int’l, Ltd.,
`
`829 F.3d 1364 (Fed. Cir. 2016) ............................................................. 19, 31
`
`In re NTP, Inc.,
`
`654 F.3d 1279 (Fed. Cir. 2011) ....................................................... 31, 38, 40
`
`In re Ratti,
`
`270 F.2d 810 (C.C.P.A. 1959)............................................................... 28, 30
`
`InTouch Techs., Inc. v. VGO Commc'ns, Inc.,
`
`751 F.3d 1327 (Fed. Cir. 2014) ............................................................. 39, 41
`
`Johns Manville Corp. v. Knauf Insulation, Inc.,
`
`IPR2018-00827 Paper 9 (PTAB Oct. 16, 2018) .............................. 34, 38, 40
`
`KSR Int'l Co. v. Teleflex Inc.,
`
`550 U.S. 398 (2007) ........................................................................ 33, 39, 41
`
`Plantronics, Inc. v. Aliph, Inc.,
`
`724 F.3d 1343 (Fed. Cir. 2013) ....................................................... 34, 38, 40
`
`SAS Inst., Inc. v. Iancu,
`
`138 S. Ct. 1348 (2018) .......................................................................... 19, 31
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`
`200 F.3d 795 (Fed. Cir. 1999) ...................................................................... 8
`
`Wi-LAN USA, Inc. v. Apple Inc.,
`
`830 F.3d 1374 (Fed. Cir. 2016) ...................................................................12
`
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`
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`Statutes
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`35 U.S.C. § 312 ....................................................................................................32
`
`Other Authorities
`
`MPEP 2143.01 ................................................................................................ 28, 30
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`UPDATED LIST OF EXHIBITS
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`
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`No.
`
`2101-2119 Reserved
`
`Description
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`
`PCT Application Serial No. PCT/US2013/075767
`(Publication No. WO/2014/143276)
`
`U.S. Patent Application Serial No. 14/109,007 (Publication
`No. 2014/0236021)
`
`Reserved
`
`Curriculum Vitae of Duncan L. MacFarlane, Ph.D., P.E.
`
`Board’s Institution Decision, IPR2019-000916, Paper 16,
`October 18, 2019 (“DI”)
`
`Board’s Final Written Decision, IPR2019-00916, Paper 39,
`October 14, 2020
`
`2126-2130 Reserved
`
`Declaration of Duncan L. MacFarlane, Ph.D., P.E. in Support
`of Patent Owner’s Response to Petition in IPR2020-00175,
`September 10, 2020
`
`Excerpt of Record of Oral Hearing held March 25, 2021,
`IPR2020-00175, Paper 25, April 14, 2021
`
`Board’s Institution Decision, IPR2020-00175, Paper 11, June
`17, 2020
`
`Definitions of IDENTIFY in The Free Dictionary
`
`Definitions of DETECT in The Free Dictionary
`
`Declaration of Duncan L. MacFarlane, Ph.D., P.E. in Support
`of Patent Owner’s Response, November 12, 2021
`
`2136
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`2132
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`2133
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`2134
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`2135
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`2136
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`Atty. Dkt. No.: OMSC0119IPR1
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`Omni MedSci, Inc. (“Omni”), submits this Response to the Petition for Inter
`
`Partes Review (“Petition,” Paper 1) that Apple Inc. (“Apple”) filed against Claims
`
`1-23 (“Challenged Claims”) of U.S. Patent No. 10,517,484 (“the ‘484 Patent”).
`
`I.
`
`Introduction
`
`In Ground 1, Apple challenges independent Claims 1, 7, and 15, and
`
`dependent Claim 17 as obvious under 35 U.S.C. § 103 using a combination of U.S.
`
`Patent No. 9,241,676 (“Lisogurski”) (Ex. 1011) and U.S. Patent Pub. 2005/0049468
`
`(“Carlson”) (Ex. 1009).
`
`In Ground 2, Apple challenges independent Claims 1, 7, and 15, and
`
`dependent Claims 2–4, 8–12, and 16–22 as obvious under 35 U.S.C. § 103 using a
`
`combination of Lisogurski, Carlson, and U.S. Patent No. 8,108,036 (“Tran”) (Ex.
`
`1064).
`
`In Ground 3, Apple challenges dependent Claims 5 and 13 as obvious under
`
`35 U.S.C. § 103 using a combination of Lisogurski, Carlson, Tran, and U.S. Patent
`
`No. 8,725,226 (“Isaacson”) (Ex. 1063).
`
`In Ground 4, Apple challenges dependent Claims 6, 14, and 23 as obvious
`
`under 35 U.S.C. § 103 using a combination of Lisogurski, Carlson, Tran, and U.S.
`
`Patent Publication No. 2012/0197093 (“Valencell-093”) (Ex. 1005) “with or
`
`without” Isaacson.
`
`The Board should confirm the patentability of all claims.
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`For all Grounds, Apple relies on just two references, Lisogurski and Carlson,
`
`to disclose the “increasing a pulse rate” limitation recited in the challenged
`
`independent claims. Neither reference teaches or suggests the limitation, alone or in
`
`combination. Lisogurski fails to teach or suggest that cardiac cycle modulation
`
`(“CCM”) increases SNR as claimed. Apple does not dispute Dr. MacFarlane’s
`
`testimony that the trivial changes in firing rate during CCM “would have no
`
`measurable effect on SNR.” (Ex. 2136, ¶ 83.)1 On the contrary, Lisogurski teaches
`
`a different modulation technique (drive cycle modulation) to address noise by
`
`modulating at a frequency far above that of ambient noise and the 0.5–3 Hz
`
`frequency of CCM. But the Petition makes no reference to Lisogurski’s drive cycle
`
`modulation. Lisogurski’s use of high frequency modulation, in addition to CCM,
`
`confirms that the trivial changes in LED firing rates that occur in the 0.5–3 Hz range
`
`do not increase SNR.
`
`Apple also asserts Lisogurski’s teaching of CCM can be modified “as taught
`
`by Carlson” to render the pulse rate limitation obvious. (Pet. 53.) Modifying
`
`Lisogurski “as taught by Carlson” is not viable because it impermissibly changes
`
`Lisogurski’s CCM principle of operation. Increasing CCM’s LED pulse rate to
`
`1000 Hz or higher, as Carlson teaches, is far beyond a human heart rate, changing
`
`
`1 All emphasis added unless otherwise indicated.
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`the core principle of the teaching Apple relies on. Apple, therefore, has not
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`established a prima facie obviousness of the Challenged Claims.
`
`In Ground 2, Apple challenges dependent Claims 2, 10, and 18 (“artificial
`
`intelligence”). Apple argues that Lisogurski + Carlson + Tran make these claims
`
`obvious. Apple does not name which of its 10 background references provide a
`
`motivation to combine Tran with Lisogurski. The Petition does not discuss any
`
`reason an ordinary artisan would have been motivated to combine Tran with Carlson,
`
`as needed to make the full combination.
`
`Also in Ground 2, Apple challenges dependent Claims 3, 8, and 16 (“object
`
`identification/detection”). Apple quotes Lisogurski’s statement, “the system may
`
`detect a signal indicative of a system error such as … a probe-off signal.” (Pet. 62.)
`
`A signal that a sensor is missing does not “detect an object” (as Claim 16 requires),
`
`nor does it “identify an object” as a particular thing (as Claims 3 and 8 require).
`
`In Ground 3, Apple challenges dependent Claims 5 and 13 (“spatially
`
`separated detectors”). Apple asserts these claims require a combination of four
`
`references: Lisogurski + Carlson + Tran + Isaacson. But the Petition only discusses
`
`reasons to combine Lisogurski + Isaacson, rather than the full combination that
`
`supports Ground 3. The Petition merely says that the four references are analogous
`
`art, but it never explains a motivation-teaching-suggestion to combine all four
`
`references. Apple cannot combine four references to challenge the spectral
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`fingerprinting claims absent a motivation-teaching-suggestion to combine all four
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`references.
`
`In Ground 4, Apple challenges dependent Claims 6, 14, and 23: (“reflective
`
`surface”). Apple asserts these claims require a combination of five references:
`
`Lisogurski + Carlson + Tran + Isaacson + Valencell-093. But the Petition only
`
`discusses reasons to combine Lisogurski + Valencell-093, rather than the full
`
`combination that supports Ground 4. The Petition merely says that four of the five
`
`references are analogous art, and it never explains a motivation-teaching-suggestion
`
`to combine all five references. Apple cannot combine five references to challenge
`
`the reflective surface claims absent a motivation-teaching-suggestion to combine all
`
`five references.
`
`II. Overview of the ‘484 Patent
`
`A. The ‘484 Patent discloses innovative systems for making
`accurate non-invasive physiological measurements
`
`The Challenged Claims of the ‘484 Patent are directed to a measurement
`
`system for making more accurate non-invasive physiological measurements of a
`
`material or substance, including human tissue and blood. The ‘484 Patent describes
`
`application of the measurement system to “non-invasive glucose monitoring,” and
`
`“non-invasive monitoring of blood constituents or blood analytes” using “near-
`
`infrared spectroscopy.” (See, e.g., Ex. 1001 at 10:2-7; 2:64-3:30.) Figure 24 of the
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`‘484 Patent, reproduced below (color added), shows a high-level overview of an
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`exemplary physiological measurement system 2400. The system includes a wearable
`
`measurement device (blue), a smart phone or tablet (red), and a cloud-based server
`
`(yellow). (Id. 17:10-13; 15:53-61; 7:65-8:27.)
`
`
`
`The ‘484 Patent discloses inspecting a sample “by comparing different
`
`features, such as wavelength (or frequency), spatial location, transmission,
`
`absorption, reflectivity, scattering, fluorescence, refractive index, or opacity” of the
`
`sample. (Ex. 1001 at 10:2-7.) This may entail measuring various optical
`
`characteristics of the sample as a function of the wavelength of the source light, e.g.,
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`by varying the wavelength of the source light or by using a broadband source of
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`light. (Ex. 1001 at 10:8-18.)
`
`The ‘484 Patent describes various techniques for improving the signal-to-
`
`noise ratio (“SNR”) of the physiological measurement made using the light source.
`
`For example, the SNR may be improved by increasing the light intensity from the
`
`light source. Ex. 1001 at 15:53-55 (“a higher light level or intensity may improve
`
`the signal-to-noise ratio for the measurement”). As another example, in a “pulsed
`
`mode of operation,” the light source can increase the pulse rate to improve SNR.
`
`(Ex. 1001 at 26:29-34.)
`
`As to the latter, the specification states, “By use of an active illuminator, a
`
`number of advantages may be achieved” including “higher signal-to-noise ratios.”
`
`(Ex. 1001 at 16:61-65.) PCT Application Serial No. PCT/US2013/075767
`
`(Publication No. WO/2014/143276) (Ex. 2120) is incorporated by reference into the
`
`‘484 specification and 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 2:26-29; Ex. 2120, ¶ [0079].) This
`
`follows U.S. Patent Application Serial No. 14/109,007 (Publication No.
`
`2014/0236021) (Ex. 2121), also incorporated by reference into the ‘484
`
`specification, which discloses that the modulation frequency of the light source is
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`non-zero and can range between “0.1-100kHz.” (Ex. 1001 at 2:36-39; Ex. 2121,
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`¶ [0045].)
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`The “light source” can comprise several components. For example, Figure 20
`
`shows a light source (2000) that uses “pulse electronics” (yellow) to pulse a diode
`
`(blue). (Ex. 1001 at 28:19-21; FIG. 20.)
`
`The pulse electronics in this example can drive the diode with a “0.5-2.0 ns
`
`
`
`pulsed output, and with a pulse repetition rate between one kilohertz to about 100
`
`MHz or more.” (Ex. 1001 at 28:24-26.)
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`B. AIA status and Priority Date
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`Omni does not contest that the ‘484 Patent is an AIA patent. Apple asserts in
`
`a footnote that the ‘484 Patent “violates 37 C.F.R. §1.78(d)(2)” (Pet. 15, n.2) but
`
`offers no evidence or analysis to support its conclusory statement. And Apple’s
`
`assertion is irrelevant for this IPR because Omni does not contest that the references
`
`Apple relies on (Lisogurski, Carlson, Tran, and Valencell-093, and Isaacson) are
`
`prior art to the ‘484 Patent.
`
`III. Claim Construction
`
`While Omni does not necessarily agree with Petitioner regarding its proposed
`
`constructions, none of the claim terms Apple identifies for construction relate to the
`
`disputed issues in this Response except for the pulse rate limitation. Vivid Techs.,
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`Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“only those terms
`
`need be construed that are in controversy, and only to the extent necessary to resolve
`
`the controversy”).
`
`A. The “pulse rate” limitation (all claims)
`
`Independent claim 1 of the ‘484 Patent is reproduced below with emphasis
`
`added to the “wearable device … increasing a pulse rate” limitation:
`
`1. A system for measuring one or more physiological parameters and
`
`for use with a smart phone or tablet, the system comprising:
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`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
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`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 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.
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`Apple identifies three constructions for the pulse rate limitation without
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`committing to any of them. (Pet. 20-21.) In the IPR2020-00175 Final Written
`
`Decision (“FWD”), the Board said the nearly identical2 pulse rate limitation needed
`
`no construction, distinguishing it from the “pulse rate” limitation in IPR2019-00916.
`
`(Ex. 2133 at 18-19.) Likewise, the pulse rate limitation in the ‘484 Patent needs no
`
`construction.
`
`B.
`
`“to identify an object” (Claims 3 and 8)
`
`Claims 3 and 8 recite: “the wearable device is at least in part configured to
`
`identify an object[.]” Apple does not propose a construction for “to identify an
`
`object.” The word “identify” is a common word that means “to recognize or establish
`
`as being a particular person or thing.” (Ex. 2134 p. 2, quoting Random House
`
`Kernerman Webster's College Dictionary (2010).)3
`
`
`2 The only difference between the two limitations is the initial phrase of the
`
`limitations. In the ‘299 Patent (at issue in IPR2020-00175), the pulse rate limitation
`
`begins, “the system configured to,” whereas in the ‘484 Patent the limitation begins,
`
`“the wearable device configured to.” Otherwise, the limitations are identical.
`
`3 Omni uses this 2010 definition because it was published shortly before the 2012
`
`priority date of the ‘484 Patent. The other dictionary definitions are nearly identical.
`
`(Ex. 2134, pp. 1.)
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`The claims themselves confirm this ordinary meaning. For example, Claim 16
`
`is nearly identical with Claims 3 and 8—the Petition lumps Claim 16 with Claims 3
`
`and 8 (see Pet. 62)—but Claim 16 uses “to detect an object” instead of “to identify
`
`an object.” This difference in claim language creates a presumption that
`
`identification, which requires recognizing or establishing an object as a particular
`
`thing, differs from detection, which merely requires noticing an object’s presence
`
`(see Ex. 2135). Wi-LAN USA, Inc. v. Apple Inc., 830 F.3d 1374, 1391 (Fed. Cir.
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`2016) (“A construction that would cause two differently worded claims to cover
`
`exactly the same claim scope would render one of the claims superfluous, so we
`
`apply a presumption against such constructions.”)
`
`The ‘484 Patent specification (Ex. 1001) also confirms that, to “identify an
`
`object” requires an object be identified as a particular thing:
`
`• 7:21-24: “Hyper-spectral images may provide spectral information to
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`identify and distinguish between spectrally similar materials,
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`providing the ability to make proper distinctions among materials
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`with only subtle signature differences;”
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`• 8:18-22: “the active remote sensing or hyper-spectral imaging
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`information could also be combined with two-dimensional or three-
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`dimensional images to provide a physical picture as well as a chemical
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`composition identification of the materials;”
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`• 12:57-60: “it may be advantageous to use pattern matching algorithms
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`and other software and mathematical methods to identify the blood
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`constituents of interest;”
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`• 15:45-48: “Various signal processing methods may be used to identify
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`and quantify the concentration of cholesterol 876 and/or glucose 877,
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`or some of the other blood constituents.”
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`So, “to identify an object” in Claims 3 and 8 means “to recognize or establish
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`an object as being a particular thing.”
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`C.
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`“to detect an object” (Claim 16)
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`Claim 16 recites: “the wearable device is at least in part configured to detect
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`an object[.]” Apple does not propose a construction for “to detect an object.” The
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`word “detect” is a common word that means “to discover or notice the existence or
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`presence of.” (Ex. 2135 p. 1, quoting Random House Kernerman Webster's College
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`Dictionary (2010).)
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`As noted in the prior section, Claims 3 and 8 use “identify,” creating a
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`presumption that “detect” in Claim 16 has a different meaning. Wi-LAN, 830 F.3d at
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`1391. The specification (Ex. 1001), confirms the ordinary meaning of “detect”:
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`• 11:22-37: “[glucose] signatures may fall in valleys of water absorption,
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`permitting non-invasive detection through the body;”
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`• 13:23-24: “In one embodiment, these ketone bodies are detected;”
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`• 14:54-64: “the non-invasive SWIR measurement should be able to
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`detect HbAle with appropriate pattern matching algorithms;”
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`• 15:31-33: “A further example of blood compositions that can be
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`detected or measured using near-infrared light includes cholesterol
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`monitoring;”
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`• 25:26: “detect any anomalies in the teeth;”
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`• 35:65-67: “The discussion thus far has included use of near-infrared or
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`SWIR spectroscopy in applications such as … detection of illicit
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`drugs.”
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`So, “to detect an object” in Claim 16 means “to discover or notice the
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`existence or presence of something.”
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`IV. The Board should deny the Petition because it fails to establish
`prima facie obviousness of the Challenged Claims
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`A. Grounds 1 & 2: Apple has failed to show that Lisogurski,
`alone, or combined with Carlson, renders the “pulse rate”
`limitation obvious
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`The three independent claims, Claims 1, 7, and 15, from which all other
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`Challenged Claims depend, require: “the wearable device configured to increase the
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`signal-to-noise ratio ... by increasing a pulse rate of at least one of the plurality of
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`semiconductor sources from an initial pulse rate.” Apple asserts that Lisogurski
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`discloses this limitation, and if not disclosed in Lisogurski alone, it would have been
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`obvious to modify Lisogurski “as taught by Carlson.” (Pet. 48-53.) Apple asserts no
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`other basis for finding the pulse rate limitation obvious.
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`1.
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`Lisogurski alone: The changes in LED firing rate
`during Lisogurski’s CCM, which Apple relies on for
`obviousness, undisputedly “have no measurable effect
`on SNR”
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`Regarding Lisogurski alone, Apple makes two arguments. First, Apple relies
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`on Lisogurski’s disclosure of “first” and “second” modulation modes, “sampling
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`rate” changes, and Omni’s expert’s “general statement” that a faster modulation rate
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`may “lower the background noise.” (Pet. 48-50.) Second, Apple “also” relies on
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`“Lisogurski’s cardiac cycle modulation.” (Pet. 50-51.) But both arguments rely on
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`the same disclosure regarding Lisogurski’s CCM, so the “also” in Apple’s second
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`argument is inapt. (Ex. 2136, ¶ 88.)
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`In the Institution Decision (“DI”), the Board contended that Apple did not
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`limit its Lisogurski-alone arguments to CCM, quoting Apple’s expert’s statement
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`that “‘cardiac cycle modulation’ also teaches [the pulse rate] limitation.” (DI 31,
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`emphasis in original). But, as explained below, Apple cites and discusses only
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`Lisogurski’s descriptions of CCM and Apple does not cite or discuss “firing rate”
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`changes other than in CCM.
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`a)
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`Apple’s first Lisogurski-alone argument
`depends on CCM
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`Apple’s first argument asserts that Lisogurski’s system can “dynamically
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`adjust the parameters of light emitted by the LEDs.” (Pet. 48.) Apple cites “Ex. 1011,
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`9:46-52; id., 37:6-22” for support. At 9:46-52, Lisogurski is expressly discussing
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`CCM: “the system may modify the cardiac modulation technique … .” At 37:6-22,
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`Lisogurski is discussing CCM’s “second mode”: The text describes Figure 19, a flow
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`chart “showing steps to adjust a cardiac cycle modulation[.]” (Ex. 1011, 36:48-49.)
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`Apple’s first Lisogurski-alone argument thus depends on CCM. (Ex. 2136, ¶ 89.)
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`The other statements Apple makes in its first Lisogurski-alone argument do
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`not relate to Lisogurski’s “firing rate.” Apple discusses “sampling rate,” which is
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`irrelevant to the “pulse rate” limitation. (Ex. 2136, ¶ 90.) Apple asserts, “increased
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`sampling rate results in more samples” so, “signal to noise [ratio] improves because
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`the noise is spread across more samples.” (Pet. 49.) But any SNR improvement from
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`sampling rate changes do not meet the claims’ requirement of increasing the LED
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`pulse rate. (Ex. 2136, ¶ 90.)
`
`Apple next cites Dr. MacFarlane’s “general statement” that increasing LED
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`pulse rate can sometimes “lower the background noise.” (Pet. 50.) The statements
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`Apple quotes were not about Lisogurski, as Apple has admitted. (Ex. 2132 at 4:11-
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`13.) Apple’s attorney merely asked Dr. MacFarlane an abstract question. Apple
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`never asked Dr. MacFarlane whether Lisogurski’s CCM firing rate increases affect
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`SNR, presumably because Apple knew the answer would be “no.” Dr. MacFarlane’s
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`“general statement” does not apply to Lisogurski’ CCM because, as Dr. MacFarlane
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`explains in his declaration, the firing rate changes during CCM do not increase SNR.
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`(Ex. 2136, ¶ 91.)
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`b) Apple’s second Lisogurski-alone argument
`“also” depends on CCM
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`Apple transitions to its second Lisogurski-alone argument by asserting,
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`“Lisogurski’s ‘cardiac cycle modulation’ also satisfies [the pulse rate] limitation
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`…. Lisogurski’s ‘cardiac cycle modulation’ varies light drive signal parameters,
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`such as firing rate, to remain ‘substantially synchronous[] with’ a subject’s heart
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`rate.” (Pet 50.) Apple then discusses how “the firing rate will increase whenever a
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`subject’s heart rate increases” and calls it “[t]his increase in firing rate.” (Id.) Apple’s
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`second argument thus depends expressly on CCM. (Ex. 2136, ¶ 93.)
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`In the DI, the Board sought to distance Apple’s arguments from CCM by
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`asserting, “Petitioner’s references to ‘firing rate’ in its discussion of the pulse rate
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`limitation refers to the pulse rate of the LED, not to the rate of CCM.” (DI 32.) But
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`that ignores the Petition: Apple expressly says “the firing rate” is linked to “a
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`subject’s heart rate.” (Pet. 50.) And Apple’s sole support for its second Lisogurski-
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`alone argument is CCM:
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`Atty. Dkt. No.: OMSC0119IPR1
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`• Ex. 1011, 25:46-61: “[T]he system may generate a light drive signal that
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`varies with a period the same as or closely related to the period of the
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`cardiac cycle, thus generating a cardiac cycle modulation. … [T]he system
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`may use a cardiac cycle modulation that spans several cardiac cycles[.]”
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`• Ex. 1003, ¶¶ 181-182: “Lisogurski’s ‘cardiac cycle modulation’ also
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`teaches
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`this
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`limitation. Lisogurski describes
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`its “cardiac cycle
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`modulation” : [quoting Ex. 1011, 25:46-52.] A person of ordinary skill in
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`the art would have understood these disclosures to mean ….”
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`• Ex. 1011, 42:50-54: The basis for Lisogurski’s statement, “the systole
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`period cardiac cycle modulation technique may provide improved
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`performance.” (42:55-58.)
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`• Ex. 1011, 25:66-26:14: “[P]hysiological pulses may be cardiac pulses,
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`respiratory pulses, muscular pulses, any other suitable pulses ….”
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`• Ex. 2125, ’533 FWD at 29: “Lisogurski teaches correlating LED pulse rate
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`and cardiac cycle rate ….”
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`Apple cites no evidence that Lisogurski discloses “firing rate” increases other
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`than as part of CCM. (Ex. 2136, ¶¶ 94-95.) In the DI, the Board asserts that the
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`Petition’s references to “firing rate” are not limited to CCM, DI 32, contrary to the
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`Petition’s explicit statements. The sentence the Board relies on for its assertion,