UNITED STATES PATENT AND TRADEMARK OFFICE
`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`OMNI MEDSCI, INC.,
`Patent Owner.
`
`______________
`
`
`U.S. Patent No. 10,517,484
`
`IPR Case No.: IPR2021-00453
`
`
`______________
`
`
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE TO PETITION
`FOR INTER PARTES REVIEW UNDER 37 C.F.R. § 42.107
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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 CONTENTS ........................................................................................ i
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`TABLE OF AUTHORITIES ................................................................................. ii
`
`LIST OF EXHIBITS ............................................................................................. iii
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`I.
`
`II.
`
`Introduction ................................................................................................. 1
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`Overview of the ‘484 Patent ........................................................................ 3
`
`A.
`
`The ‘484 Patent discloses innovative systems for making
`accurate non-invasive physiological measurements ........................... 3
`
`B.
`
`AIA status and Priority Date .............................................................. 7
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`III. Claim Construction ...................................................................................... 7
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`IV. The Board should deny the Petition because it fails to establish prima
`facie obviousness of the Challenged Claims ................................................ 8
`
`A. Grounds 1 & 2: Petitioner has failed to show that Lisogurski,
`alone, or combined with Carlson, renders the “pulse rate”
`limitation obvious .............................................................................. 8
`
`1.
`
`2.
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`Lisogurski alone: The changes in LED firing rate during
`Lisogurski’s cardiac cycle modulation, which Petitioner
`relies on for obviousness, undisputedly “have no
`measurable effect on SNR” ...................................................... 8
`
`Lisogurski and Carlson: Modifying Lisogurski “as taught
`by Carlson” abolishes Lisogurski’s principle of operation ......14
`
`B.
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`Patent Owner need not address Grounds 3 and 4 ...............................18
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`V.
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`Conclusion ..................................................................................................19
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`Certificate of Service ............................................................................................20
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`Certificate of Compliance Pursuant to 37 C.F.R. § 42.24 ......................................21
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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 AUTHORITIES
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`Cases
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`In re Ratti,
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`270 F.2d 810 (C.C.P.A. 1959).....................................................................15
`
`
`
`Other Authorities
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`MPEP 2143.01 ......................................................................................................15
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`ii
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`LIST OF EXHIBITS
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`Atty. Dkt. No.: OMSC0119IPR1
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`2120
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`2121
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`2122
`2123
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`2124
`
`Description
`No.
`2101-2119 Reserved
`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
`Board’s Final Written Decision, IPR2019-000916, Paper 39,
`October 14, 2020
`2126-2130 Reserved
`2131
`Declaration of Duncan L. MacFarlane, Ph.D., P.E.
`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
`
`2125
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`2132
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`2133
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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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`Omni MedSci, Inc. (“Patent Owner”), submits this Preliminary Response to
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`the Petition for Inter Partes Review (“Petition,” Paper 1) that Apple Inc.
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`(“Petitioner”) filed against Claims 1-23 (“Challenged Claims”) of U.S. Patent No.
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`10,517,484 (“the ‘484 Patent”).
`
`I.
`
`Introduction
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`In Ground 1, Petitioner challenges independent Claims 1, 7, and 15, and
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`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
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`(“Carlson”) (Ex. 1009).
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`In Ground 2, Petitioner challenges Claims independent Claims 1, 7, and 15,
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`and dependent Claims 2–4, 8–12, and 16–22 as obvious under 35 U.S.C. § 103 using
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`a combination of Lisogurski, Carlson, and U.S. 8,108,036 (“Tran”) (Ex. 1064).
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`In Ground 3, Petitioner 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, Petitioner 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
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`without” Isaacson.
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`1
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`The Board should deny institution. Petitioner does not establish prima facie
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`obviousness for the Challenged Claims. Petitioner relies solely on two references,
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`Lisogurski and Carlson, to disclose the “increasing a pulse rate” limitation recited
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`in the challenged independent claims. Neither reference teaches or suggests the
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`limitation, alone or in combination. Lisogurski fails to teach or suggest that cardiac
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`cycle modulation increases SNR as claimed. On the contrary, Lisogurski teaches an
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`entirely different modulation technique (drive cycle modulation) to address noise by
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`modulating at a frequency far above that of ambient noise and the 0.5–3 Hz
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`frequency of cardiac cycle modulation. But the Petition makes no reference to
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`Lisogurski’s drive cycle modulation because its use of high frequencies to combat
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`noise confirms that the trivial changes in LED firing rate that occur in the 0.5–3 Hz
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`range during cardiac cycle modulation have no effect on SNR. And modifying
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`Lisogurski “as taught by Carlson” is not a viable obviousness combination because
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`it impermissibly changes Lisogurski’s principle of operation. Increasing the LED
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`pulse rate to 1000Hz or higher as Carlson teaches is far beyond a human heart rate,
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`undermining the core principle of Lisogurski’s cardiac cycle modulation. Petitioner,
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`therefore, has not established a prima facie obviousness of the Challenged Claims.
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`II. Overview of the ‘484 Patent
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`Atty. Dkt. No.: OMSC0119IPR1
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`A. The ‘484 Patent discloses innovative systems for making
`accurate non-invasive physiological measurements
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`The Challenged Claims of the ‘484 Patent are directed to a measurement
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`system for making more accurate non-invasive physiological measurements of a
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`material or substance, including human tissue and blood. The ‘484 Patent describes
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`application of the measurement system to “non-invasive glucose monitoring,” and
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`“non-invasive monitoring of blood constituents or blood analytes” using “near-
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`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
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`measurement device (blue), a smart phone or tablet (red), and a cloud-based server
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`(yellow). (Id. at 17:10-13; 15:53-61; 7:65-8:27.)
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`The ‘484 Patent discloses inspecting a sample “by comparing different
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`features, such as wavelength (or frequency), spatial location, transmission,
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`absorption, reflectivity, scattering, fluorescence, refractive index, or opacity” of the
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`sample. (Ex. 1001 at 10:2-7.) This may entail measuring various optical
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`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.)
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`The wearable measurement device includes a light source that includes a
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`plurality of light emitting diodes to generate an output optical beam at one or more
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`optical wavelengths, including at least one wavelength between 700 and 2500
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`nanometers. (Ex. 1001 at 3:34-39; 11:3-9.) The ‘484 specification discloses two
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`alternative operating modes for the LEDs: “continuous wave or pulsed mode of
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`operation.” (Ex. 1001 at 26:29-32.)
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`The ‘484 Patent describes various techniques for improving the signal-to-
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`noise ratio (“SNR”) of the physiological measurement made using the light source.
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`For example, the SNR may be improved by increasing the light intensity from the
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`light source. Ex. 1001 at 3:13-15 (“More light intensity can help to increase the
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`signal levels, and, hence, the signal-to-noise ratio.”). As another example, in a
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`“pulsed mode of operation,” the light source can increase the pulse rate to improve
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`SNR. (Ex. 1001 at 26:29-34.)
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`As to the latter, the specification states, “By use of an active illuminator, a
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`number of advantages may be achieved” including “higher signal-to-noise ratios.”
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`(Ex. 1001 at 16:61-65.) PCT Application Serial No. PCT/US2013/075767
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`(Publication No. WO/2014/143276) (Ex. 2120) is incorporated by reference into the
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`‘484 specification and describes the use of an “active illuminator” to achieve “higher
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`signal-to-noise ratios” despite “variations due to sunlight” and the “effects of the
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`weather, such as clouds and rain.” (Ex. 1001 at 2:26-29; Ex. 2120, ¶ [0079].) This is
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`consistent with U.S. Patent Application Serial No. 14/109,007 (Publication No.
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`2014/0236021) (Ex. 2121), also incorporated by reference into the ‘484
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`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
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`shows a light source (2000) that uses “pulse electronics” (yellow) to pulse a diode
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`(blue). (Ex. 1001 at 28:19-21; FIG. 20.)
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`The pulse electronics in this example can drive the diode with a “0.5-2.0 ns
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`
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`pulsed output, and with a pulse repetition rate between one kilohertz to about 100
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`MHz or more.” (Ex. 1001 at 28:24-26.)
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`B. AIA status and Priority Date
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`Atty. Dkt. No.: OMSC0119IPR1
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`Patent Owner does not contest that the ‘484 patent is an AIA patent. Petitioner
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`asserts in a footnote that the ‘484 Patent “violates 37 C.F.R. §1.78(d)(2)” (Pet. at 15,
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`n. 2) but offers no evidence or analysis to support its conclusory statement. And
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`Petitioner’s assertion is irrelevant for this IPR because Patent Owner does not contest
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`that the references Petitioner relies on (Lisogurski, Carlson, Tran, and Valencell-
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`093, and Isaacson) are prior art to the ‘484 Patent.
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`III. Claim Construction
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`None of the claim terms Petitioner identifies for construction relate to the
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`disputed issues in this Preliminary Response except for the pulse rate limitation.
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`Petitioner identifies three constructions for the pulse rate limitation without
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`committing to any of them. (Pet. at 20-21.) In IPR2020-00175, the Board said the
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`nearly identical1 pulse rate limitation needed no construction, distinguishing it from
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`the “pulse rate” limitation in IPR2019-00916. (Ex. 2133 at 18-19.) Likewise, the
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`1 The only difference between the two limitations is the initial phrase of the
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`limitations. In the ‘299 Patent (at issue in IPR2020-00175), the pulse rate limitation
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`begins, “the system configured to,” whereas in the ‘484 Patent the limitation begins,
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`“the wearable device configured to.” Otherwise the limitations are identical.
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`pulse rate limitation in the ‘484 Patent needs no construction and carries its plain
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`and ordinary meaning.
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`IV. The Board should deny the Petition because it fails to establish
`prima facie obviousness of the Challenged Claims
`
`A. Grounds 1 & 2: Petitioner 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.” Petitioner asserts that Lisogurski
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`discloses this limitation, and if not disclosed in Lisogurski, it would have been
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`obvious to modify Lisogurski “as taught by Carlson.” (Pet. at 48-53.) Petitioner
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`asserts no other basis for finding the pulse rate limitation obvious.
`
`1.
`
`Lisogurski alone: The changes in LED firing rate
`during Lisogurski’s cardiac cycle modulation, which
`Petitioner relies on for obviousness, undisputedly
`“have no measurable effect on SNR”
`
`For the pulse rate limitation, Petitioner begins by citing and relying on
`
`Lisogurski’s disclosure of “first” and “second” modulation modes. (Pet. at 48-49,
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`quoting Ex. 1011 at 37:6-20.) Lisogurski’s “first” and “second” modulation modes
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`are both cardiac cycle modulation (“CCM”) modes: The text Petitioner quotes is
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`from a description of Figure 19, which Lisogurski says “is [a] flow chart 1900
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`showing steps to adjust a cardiac cycle modulation[.]” (Ex. 1011 at 36:48-49.) The
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`Atty. Dkt. No.: OMSC0119IPR1
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`text cited by Petitioner consistently refers to CCM and no other form of modulation.
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`Id. at 37:15-20. In its analysis of Lisogurski’s alleged disclosure of the pulse rate
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`limitation, Petitioner relies solely on CCM and does not refer to or rely on any other
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`form of modulation. (Pet. at 48-53.) For example, Petitioner asserts that an ordinary
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`artisan would understand from Lisogurski’s teaching that “the firing rate [in CCM]
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`will increase whenever a subject’s heart rate increases.” (Id. at 50.) Such increases
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`would, of course, merely maintain the existing CCM synchronization because the
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`computer-controlled firing rate can adapt to changes in heart rate instantaneously as
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`the heart rate increases (or decreases). In other words, any SNR benefits of using
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`CCM would remain constant as the heart rate increases (or decreases).
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`The teachings of both Lisogurski and Carlson confirm that modulating LEDs
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`at physiological frequencies does not increase SNR and overcome ambient noise.
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`When they modulate LEDs to avoid noise, both Lisogurski and Carlson teach that
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`the modulation frequency must be 1000 Hz (or higher)—far above ambient noise
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`and the 0.5–3 Hz heart rate where CCM operates. (Ex. 2131, ¶ 102.) Lisogurski adds
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`a separate 1000 Hz modulation, called “drive cycle modulation” (Ex. 2131, ¶ 83),
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`which “cycle[s] light output at a rate significantly greater than the cardiac cycle.”
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`(Ex. 1011 at 6:9-19.) “For example, time interval 260 (i.e., the period of the cardiac
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`cycle modulation) may be on the order of 1 second [1 Hz], while time interval 272
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`(i.e., the period of the drive cycle modulation) may be on the order of 1 ms [1000
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`Hz].” (Ex. 1011 at 16:42-46.) Likewise, as Petitioner admits, “Carlson teaches that
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`the pulse frequency (“pulse rate”) is ‘chosen in such a way that it is outside the
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`frequency spectrum of sunlight and of ambient light’ and it could be ‘1000 Hz’ or
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`‘can be chosen at any other frequency, as e.g. 2000 Hz or even higher.’ Ex.1009,
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`[0069]; Ex.1003, ¶186.” (Pet. at 52.)2 These teachings of Lisogurski and Carlson
`
`confirm that increasing the LED pulse rate within the range of the cardiac cycle (and
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`the ambient noise) will not increase SNR as claimed.
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`In addition, by the time Petitioner filed its Petition on January 22, 2021,
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`Petitioner had studied Dr. MacFarlane’s declaration (Ex. 2131)—a copy of which
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`Patent Owner filed in IPR2020-00175 three months earlier. Critically, Petitioner
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`does not dispute Dr. MacFarlane’s testimony that the trivial changes in firing rate
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`during CCM “would have no measurable effect on SNR.” (Ex. 2131, ¶ 81.) In full,
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`Dr. MacFarlane testified, without contradiction:
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`[W]hile tracking the cardiac cycle, the LED firing rate is varied just a
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`few hertz, within the range of about 0.5 Hz to 3 Hz, the frequency range
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`of the human cardiac cycle. (See, e.g., Ex. 1009, Carlson, [0066].) Such
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`a slight change in firing rate would have no measurable effect on
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`SNR because, according to Carlson and Lisogurski, this frequency
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`2 Throughout this Response, all emphasis added unless otherwise noted.
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`range is the same as the frequency range of the noise. Carlson explains,
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`“optical contributions, e.g. temporally structured day-light, and
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`electronic noise . . . are stronger in the low frequency range 0.5 Hz to
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`10 Hz than in higher frequency ranges.” (Ex. 1009, Carlson, [0009].)
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`Lisogurski is concerned with overcoming “Gaussian noise from
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`approximately 0-5 Hz.” (Ex. 1011 at 41:48; 43:15-16; 44:42-43.) Thus,
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`Lisogurski’s firing rate variations in the 0.5 to 3 Hz range will not avoid
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`the noise in the 0.5 to 10Hz range. The following graphic shows how
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`the small adjustment in Lisogurski’s firing rate will not avoid the
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`ambient noise. This illustration shows the noise range identified in
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`Carlson and Lisogurski (in red) overlaid with the cardiac cycle firing
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`rate adjustment taught in Lisogurski (in green).
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`(Ex. 2131, ¶ 81.)
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`
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`Because Petitioner does not dispute Dr. MacFarlane’s testimony, and offers
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`no evidence that the trivial LED pulse rate increases during CCM increase SNR,
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`Case No.: IPR2021-00453
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`Petitioner has not meet its burden to show that the Lisogurski’s CCM discloses or
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`Atty. Dkt. No.: OMSC0119IPR1
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`suggests the pulse rate limitation.
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`Petitioner’s citation of Dr. MacFarlane’s “general statement” that increasing
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`LED pulse rate can sometimes increase SNR (Pet. at 50) does not overcome the
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`undisputed facts regarding Lisogurski’s CCM. The statements quoted on Petition
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`page 50 were not about Lisogurski’s teachings. (Ex. 2132 at 11:11-13.) Petitioner’s
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`attorney merely asked Dr. MacFarlane an abstract question. Petitioner never asked
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`Dr. MacFarlane whether Lisogurski’s CCM firing rate increases SNR, presumably
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`because Petitioner knew the answer would be “no.” Petitioner has no evidence that
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`Dr. MacFarlane’s “general statement” applies to CCM—as Dr. MacFarlane testified
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`in his declaration, it does not. (Ex. 2131, ¶ 81.) Petitioner chose not to cross-examine
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`Dr. MacFarlane about his declaration testimony and has never disputed the evidence.
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`Petitioner next claims, “Omni has admitted that Lisogurki’s [sic] ‘cardiac
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`cycle modulation’ is a technique for ‘improving SNR.’” (Pet. at 50.) But Omni did
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`not admit that the Lisogurski device is configured “to increase SNR” by increasing
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`the LED pulse rate as the Challenged Claims require. Lisogurski merely teaches
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`that some points on the cardiac cycle may be less noisy than others, so taking
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`measurements at those points may be better. Specifically, Lisogurski used
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`“simulated waveforms” to “calculate pulse amplitudes.” (Ex. 1011 at 42:46-48.)
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`“Based on [that] analysis,” Lisogurski concluded, “noise contributes coefficients of
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`variation” of 2.6% for the PPG signal without modulation, 1.9% for the “systole
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`period modulated PPG signal,” and 3.8% for the “diastole period modulated PPG
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`signal.” (Id. at 42:50-54.)3 In other words, Lisogurski concluded that, in his
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`simulations, a systole period modulated PPG signal could reduce noise coefficients
`
`whereas diastole period modulated PPG signal could increase noise coefficients. But
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`those statements fail to teach or suggest—and do not address Patent Owner’s
`
`evidence—that the trivial increases in LED firing rate during CCM (which merely
`
`keep the modulation synchronized to the PPG signal) increases SNR. Nor do those
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`statements teach or suggest that Lisogurski “configured” his system to increase SNR
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`by increasing the LED firing rate. Instead, as the Board has twice stated, Lisogurski’s
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`“LED firing rate is varied to become or remain synchronous with a cardiac cycle,
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`not to increase signal-to-noise.” (Ex. 2124 at 30; Ex. 2133 at 47.)
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`In summary, Patent Owner presented evidence that the trivial changes in LED
`
`firing rate during Lisogurski’s CCM do not increase SNR. The evidence is
`
`undisputed—Petitioner does not address or refute it. The Petition does not make a
`
`prima facie case that Lisogurski alone renders the pulse rate limitation obvious.
`
`
`3 Petitioner miscites these lines of Lisogurski for its unsupported claim that an
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`“increase in the firing rate can increase SNR because noise is reduced 1%-4%.” (Pet.
`
`at 50-51.)
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`2.
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`Lisogurski and Carlson: Modifying Lisogurski “as
`taught by Carlson” abolishes Lisogurski’s principle of
`operation
`
`Petitioner asserts that a combination of Lisogurski and Carlson would render
`
`the pulse rate limitation obvious because “a skilled person would have found it
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`obvious to configure Lisogurski to increase the [CCM] LED firing rate (frequency)
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`in the presence of noise to increase signal-to-noise ratio as taught by Carlson.” (Pet.
`
`at 53.) The Petition explains what “as taught by Carlson” means:
`
`Carlson teaches that the pulse frequency (“pulse rate”) is “chosen in
`
`such a way that it is outside the frequency spectrum of sunlight and of
`
`ambient light” and it could be “1000 Hz” or “can be chosen at any other
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`frequency, as e.g. 2000 Hz or even higher.” . . . . Carlson expressly
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`claims actively “shift[ing] the frequency of the emitted light” during
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`operation (i.e., shifting from a first frequency to a second frequency) so
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`it is “substantially outside of frequency of noise and/or environmental
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`signals” such as sunlight.
`
`(Pet. at 52, citations omitted.)
`
`As Petitioner states, Carlson teaches that, to avoid noise from sunlight and
`
`other ambient light, the modulation frequency should be “substantially outside of
`
`frequency of noise and/or environmental signals.” (Ex. 1009, Claims 11-12.)
`
`Carlson gives examples for such frequencies: “above approximately 1000 Hz” and
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`“2000 Hz or even higher.” (Id., ¶ [0069].) Carlson does not teach or suggest avoiding
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`14
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`ambient noise by using frequencies in the 0.5–3 Hz range, i.e., where the noise is
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`Atty. Dkt. No.: OMSC0119IPR1
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`most prevalent.
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`Petitioner’s proposed combination, to “increase the [CCM] LED firing rate”
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`of Lisogurski “as taught by Carlson,” would increase the CCM firing rate to 1000 Hz
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`or more. This is not a viable obviousness combination because it completely
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`abolishes CCM’s principle of operation. If a “proposed modification or combination
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`of the prior art would change the principle of operation of the prior art invention
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`being modified, then the teachings of the references are not sufficient to render the
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`claims prima facie obvious.” MPEP 2143.01, citing In re Ratti, 270 F.2d 810, 813
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`(C.C.P.A. 1959).
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`As the Board has noted, and Petitioner does not dispute, the purpose of
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`Lisogurski’s CCM is to “modulate the light drive signal to have a ‘period the same
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`as or closely related to the period of [a] cardiac cycle.’” (Ex. 2133 at 24.) Remaining
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`synchronous with various physiological pulses of interest is the “core principle of
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`operation of cardiac cycle modulation.” (Ex. 2131, ¶ 53.) The frequency range of the
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`human cardiac cycle is about 0.5–3 Hz. (Ex. 2131, ¶ 81.) Increasing Lisogurski’s
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`CCM LED firing rate to be “substantially outside the of frequency of noise and/or
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`environmental signals,” e.g., “above 1000 Hz” as Carlson teaches (Pet. at 52), would
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`require modulating the LEDs at frequencies far above the 0.5–3 Hz of the cardiac
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`cycle and the CCM firing rate would no longer be synchronous. (Ex. 2131, ¶¶ 81,
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`15
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`104-105.) Because such a modification would abolish the core principle of operation
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`Atty. Dkt. No.: OMSC0119IPR1
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`of Lisogurski’s CCM, “configur[ing] Lisogurski to increase the LED firing rate
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`(frequency) in the presence of noise to increase signal-to-noise ratio as taught by
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`Carlson” (Pet. at 53) would not have been obvious to an ordinary artisan. (Ex. 2131,
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`¶¶ 104-105.)
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`Nor does Lisogurski’s “second mode” of CCM support increasing the CCM
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`firing rate to 1000 Hz or more. Lisogurski describes four “second mode”
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`alternatives, none of which increase the firing rate of the LEDs: (a) “stop cardiac
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`cycle modulation [and emit light of constant brightness],” (b) “increase emitter
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`intensity” during cardiac cycle modulation, (c) “lengthen the ‘on’ periods” (i.e., duty
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`cycle) of cardiac cycle modulation, or (d) “alter the cardiac cycle modulation
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`techniques as described above with relation to Figure 8B.” (Ex. 1011 at 37:15-22.)
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`Lisogurski’s first three “second mode” examples plainly do not increase the
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`LED firing rate. In its IPR2019-00916 FWD (Ex. 2125), the Board stated that the
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`last example encompassed “changing the LED firing rate.” (Ex. 2125 at 33.) But,
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`as Figure 8B and its accompanying text confirm, that was incorrect. Figure 8B does
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`not teach or suggest varying the firing rate in the “second mode.” Figure 8B,
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`reproduced below, is a “timing diagram” showing first and second modes of 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, Fig. 8B (color added)
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`
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`During time interval 824, “the system may operate in a first mode” where a
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`continuous IR light drive signal (840) monitors the cardiac cycle (836) and
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`“modulate[s] red light drive signal 838 accordingly.” (Ex. 1011 at 24:44-49.) But,
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`if the blood oxygen level drops below a threshold, CCM begins operating in a second
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`mode (time interval 828 highlighted in yellow, above). Id., 24:49-57.
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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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`Lisogurski describes this “second mode” as follows:
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`During time interval 828 following time point 826, the system may
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`operate in a second mode. For example, as illustrated, the system may
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`use red light drive 55 signal 838 to monitor cardiac activity
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`throughout a cardiac pulse cycle, and may modulate IR light drive
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`signal 840 accordingly.
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`(Ex. 1011 at 24:52-57.)
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`Thus, when Lisogurski says, “alter the cardiac cycle modulation techniques
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`as described above with relation to Figure 8B” (Ex. 1011 at 37:20-22), he is merely
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`describing swapping the functions of the IR and red-light drive signals. As shown
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`in Figure 8B, the firing rate of the modulated LED remains synchronized to the PPG
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`signal.
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`Nothing in Lisogurski’s description of the “second mode,” including Figure
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`8B, is evidence that Lisogurski would, “as taught by Carlson,” fire the LEDs 1000
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`times faster than the PPG signal. Thus, the Petition fails to make a prima facie case
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`that “a skilled person would have found it obvious to configure Lisogurski to
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`increase the [CCM] LED firing rate . . . as taught by Carlson.” (Pet. at 53)
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`B.
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`Patent Owner need not address Grounds 3 and 4
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`Grounds 3 and 4 address only dependent claims. Because Petitioner has failed
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`to show that the independent claims are unpatentable, Patent Owner need not address
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`Grounds 3 and 4.
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`V. Conclusion
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`Atty. Dkt. No.: OMSC0119IPR1
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`Patent Owner asks the Board deny the Petition for inter partes review of the
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`‘484 Patent.
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`
`
`
`
`Dated: May 10, 2021
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`
`
`
`
`Respectfully submitted,
`
`
`
` /Thomas A. Lewry/
`Thomas A. Lewry (Reg. No. 30,770)
`John S. LeRoy (Reg. No. 48,158)
`John M. Halan (Reg. No. 35,534)
`Christopher C. Smith (Reg. No. 59,669)
`Andrew B. Turner (Reg. No. 63,121)
`BROOKS KUSHMAN P.C.
`1000 Town Center, Twenty-Second Floor
`Southfield, Michigan 48075
`Telephone: (248) 358-4400
`
`Attorneys for Omni MedSci, Inc.
`
`
`
`
`
`
`19
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`Case No.: IPR2021-00453
`Patent No.: 10,517,484
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`
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`Atty. Dkt. No.: OMSC0119IPR1
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`Certificate of Service
`
`The undersigned hereby certifies that on May 10, 2021, a complete and entire
`copy of PATENT OWNER’S PRELIMINARY RESPONSE TO PETITION
`FOR INTER PARTES REVIEW UNDER 37 C.F.R. § 42.107 and all Exhibits,
`was served via electronic mail by serving the correspondence email address of
`IPRnotices@sidley.com, which delivers to the following lead and back-up counsel:
`
`
`LEAD COUNSEL
`Jeffrey P. Kushan (Reg. No. 43,401)
`SIDLEY AUSTIN LLP
`1501 K Street NW
`Washington, DC 20005
`(202) 736-8914
`
`BACK-UP COUNSEL
`Ching-Lee Fukuda (Reg. No. 44,334)
`Sidley Austin LLP
`787 Seventh Avenue
`New York, NY 10019
`
`Thomas A. Broughan III (Reg. No. 66,001)
`Sidley Austin LLP
`1501 K Street NW
`Washington, DC 20005
`
`Sharon Lee (pro hac vice)
`
`
`
`Respectfully submitted,
`
`
` /Thomas A. Lewry/
`Thomas A. Lewry (Reg. No. 30,770)
`John S. LeRoy (Reg. No. 48,158)
`John M. Halan (Reg. No. 35,534)
`Christopher C. Smith (Reg. No. 59,669)
`Andrew B. Turner (Reg. No. 63,121)
`BROOKS KUSHMAN P.C.
`1000 Town Center, Twenty-Second Floor
`Southfield, Michigan 48075
`Telephone: (248) 358-4400
`
`Attorneys for Omni MedSci, Inc.
`
`20
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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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`Certificate of Compliance Pursuant to 37 C.F.R. § 42.24
`
`
`
`
`This paper complies with the type-volume limitation of 37 C.F.R. § 42.24.
`
`The paper contains 3,519 words, excluding the parts of the paper exempted by
`
`§ 42.24(a).
`
`This paper also complies with the typeface requirements of 37 C.F.R.
`
`§ 42.6(a)(ii) and the type style requirements of § 42.6(a)(iii)&(iv).
`
`
`Dated: May 10, 2021
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
` /Thomas A. Lewry/
`Thomas A. Lewry (Reg. No. 30,770)
`John S. LeRoy (Reg. No. 48,158)
`John M. Halan (Reg. No. 35,534)
`Christopher C. Smith (Reg. No. 59,669)
`Andrew B. Turner (Reg. No. 63,121)
`BROOKS KUSHMAN P.C.
`1000 Town Center, Twenty-Second Floor
`Southfield, Michigan 48075
`Telephone: (248) 358-4400
`
`Attorneys for Omni MedSci, Inc.
`
`21
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`