Trials@uspto.gov
`571-272-7822
`
`Paper 22
`Date: August 3, 2022
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.,
`Petitioner,
`v.
`OMNI MEDSCI, INC.,
`Patent Owner.
`
`IPR2021-00453
`Patent 10,517,484 B2
`
`
`
`
`
`
`
`
`
`Before GRACE KARAFFA OBERMANN, BRIAN J. McNAMARA,
`and SHARON FENICK, Administrative Patent Judges.
`McNAMARA, Administrative Patent Judge.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining Some Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
`
`
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`IPR2021-00453
`Patent 10,517,484 B2
`
`I. BACKGROUND
`On August 6, 2021 we instituted an inter partes review of claims 1–23
`of U. S. Patent No. 10,517,484 B2 (“the ’484 Patent”). Paper 7 (“Dec. to
`Inst.”). Omni MedSci, Inc. (“Patent Owner’) filed a Patent Owner Response
`(Paper 10, “PO Resp.”), Apple, Inc. (“Petitioner”) filed a Petitioner Reply
`(Paper 11, “Pet. Reply”) and Patent Owner filed a Sur-reply (Paper 13, “PO
`Sur-reply”). A transcript of an oral hearing held on May 5, 2022 (Paper 20,
`“Hr’g. Tr.”) has been entered into the record.
`We have jurisdiction under 35 U.S.C. § 6. This Final Written
`Decision is issued pursuant to 35 U.S.C. § 318(a). We base our decision on
`the preponderance of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
`Having reviewed the arguments of the parties and the supporting
`evidence, we conclude that Petitioner has demonstrated by a preponderance
`of the evidence that challenged claims 1, 2, 7, and 15–23 are unpatentable
`and that Petitioner has not demonstrated challenged claims 3–6 and 8–14 to
`be unpatentable.
`
`II. THE ’484 PATENT
`The ’484 patent concerns a device that can be placed on a user’s ear or
`wrist to measure a physiological parameter. Ex. 1001 (code 57). A plurality
`of light emitting diodes generate light at an initial intensity and a receiver
`with spatially placed detectors receiving reflected light provides analog
`signals to an analog-to-digital converter (“A/D”). Id. Signal-to-noise ratio
`is improved by increasing light intensity relative to initial light intensity and
`increasing a pulse rate. Id. The system inspects a sample “by comparing
`different features, such as wavelength (or frequency), spatial location,
`transmission, absorption, reflectivity, scattering, refractive index, or opacity”
`of the sample. Id. at 10:2–7.
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`Figure 24 of the ’484 patent is reproduced below.
`
`
`
`Figure 24 of the ’484 patent
`Figure 24 is a high level overview of physiological measurement system
`2400, in which wearable measurement device 2401 with processor 2402 and
`transmitter 2403 communicates measurements over link 2404 to smart phone
`or tablet 2405. Id. at 32:45–33:4. An application program in smart phone or
`tablet 2405 communicates some or all of its processed data over link 2406 to
`cloud based server 2407, which can augment the data with additional
`value-added processing, e.g., historical processing and pattern matching
`algorithms. See id. at 33:5–34:21.
`The wearable device includes a light source having a plurality of
`LEDs, electronically driven to operate in a continuous or pulsed mode, that
`generate an output beam at one or more optical wavelengths between 700
`and 2500 nanometers. Ex. 1001, 3:34–49, 11:3–9, 28:19–21, 26:29–34,
`Fig. 20. The ’484 patent describes several techniques to improve signal
`processing to select the constituents of interest. See, e.g., id. at 15:49–17:15.
`According to the ’484 patent, “using a wider wavelength range and using
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`more sampling wavelengths may improve the ability to discriminate one
`signal from another.” Id. at 15:64–66. In addition, “a higher light level or
`intensity may improve the signal-to-noise ratio for the measurement.” Id. at
`15:53–55. The ’484 patent notes that
`it may be advantageous to pulse the light source with a particular
`pulse width and pulse repetition rate, and then the detection
`system can measure the pulsed light returned from or transmitted
`through the tissue. Using a lock-in type technique (e.g., detecting
`at the same frequency as the pulsed light source and also possibly
`phase locked to the same signal), the detection system may be
`able to reject background or spurious signals and increase the
`signal-to-noise ratio of the measurement.
`Id. at 15:67–16:8. The ’484 patent further explains that variations due to
`sunlight, time of day, and weather may also be reduced to improve the
`signal-to-noise ratio using a lock-in technique. Id. at 16:61–67.
`Higher signal-to-noise ratios may be achieved. For example, one
`way to improve the signal-to-noise ratio would be to use
`modulation and lock-in techniques. In one embodiment, the light
`source may be modulated, and then the detection system would
`be synchronized with
`the
`light source. In a particular
`embodiment, the techniques from lock-in detection may be used,
`where narrow band filtering around the modulation frequency
`may be used to reject noise outside the modulation, frequency.
`In an alternate embodiment, change detection schemes may be
`used, where the detection system captures the signal with the
`light source on and with the light source off. Again, for this
`system the light source may be modulated. Then, the signal with
`and without the light source is differenced. This may enable the
`sun light changes to be subtracted out. In addition, change
`detection may help to identify objects that change in the field of
`view.
`Id. at 16:64–17:13. Patent Owner also notes that the ’484 patent
`incorporates by reference PCT Application Serial No. PCT/US2013/075767
`(Publication No. WO/2014/143276) (Ex. 2120), which describes the use of
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`an active illuminator to achieve higher signal-to-noise ratios despite
`variations due to sunlight and weather, and U.S. Patent Application Serial
`No. 14/109,007, which discloses the modulation frequency of the light
`source can range between 0.1–100 kHz. See Paper 6, Preliminary Response
`5 (citing Ex. 1001, 2:26–29, 2:36–39; Ex. 2120 ¶ 79; Ex. 2021 ¶ 45).
`ILLUSTRATIVE CLAIM
`III.
`Claim 1, reproduced below using the paragraph designations in the
`Petition, is illustrative of the subject matter of the challenged claims.
`1(a). A system for measuring one or more physiological
`parameters and for use with a smart phone or tablet, the
`system comprising:
`(b) a wearable device adapted to be placed on a wrist or an ear
`of a user,
`light source comprising a plurality of
`(c)
`including a
`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;
`(d) 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;
`(e) 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,
`(f) wherein the detection system is configured to be synchronized
`to the light source;
`(g) 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;
`(h) 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;
`(i) 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
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`a touch screen, the smart phone or tablet configured to receive
`and process at least a portion of the output signal, wherein the
`smart phone or tablet is configured to store and display the
`processed output signal, and wherein at least a portion of the
`processed output signal is configured to be transmitted over a
`wireless transmission link;
`(j) 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;
`(k) 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;
`(l) the wearable device configured to increase the signal-to-noise
`ratio
`(1) by increasing light intensity of at least one of the
`plurality of semiconductor sources from an initial light
`intensity and
`(2) by increasing a pulse rate of at least one of the plurality
`of semiconductor sources from an initial pulse rate; and
`(m) the detection system further configured to:
` generate a first signal responsive to light received while the
`light emitting diodes are off,
`(n) generate a second signal responsive to light received while at
`least one of the light emitting diodes is on, and
`(o) increase the signal-to-noise ratio by comparing the first signal
`and the second signal.
`IV. GROUNDS OF INSTITUTION
`We instituted inter partes on all grounds asserted in the Petition, as
`shown in the following table:
`Claim(s) Challenged
`35 U.S.C. §
`1, 7, 15, 17
`103
`
`Reference(s)
`Lisogurski,1 Carlson2
`
`
`1 U.S. Patent No. 9,241,676 (Ex. 1011).
`2 U.S. Patent Publication No. 2005/0049468 (Ex. 1009).
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`Patent 10,517,484 B2
`Claim(s) Challenged
`1–4, 7–12, 15–22
`5, 13
`
`6, 14, 23
`
`
`
`35 U.S.C. §
`103
`103
`
`103
`
`Reference(s)
`Lisogurski, Carlson, Tran3
`Lisogurski, Carlson, Tran,
`Isaacson4
`Lisogurski, Carlson, Tran,
`Valencell-093,5 with or without
`Isaacson
`
`V. CLAIM CONSTRUCTION
`As the Patent Owner Response proposes constructions for terms not
`previously construed (PO Resp. 8–14), we review the parties’ claim
`construction proposals provided throughout this proceeding.
`The Pulse Rate Limitation
`A.
`The Petition proposed claim constructions for the following terms:
`lens, optical light, light source . . . configured to increase signal-to-noise
`ratio by . . . increasing a pulse rate of at least one of the plurality of
`semiconductor devices (“the pulse rate limitation”6), and cloud. Pet. 19–21.
`Patent Owner does not propose constructions for these terms. PO Resp. 8–
`10. As to the pulse rate limitation, Petitioner directs us to a related case,
`Apple Inc. v. Omni MedSci, Inc, IPR2019-00916 (“the ’916 IPR”), that
`concerned U.S. Patent No. 9,651,533 (“the ’533 patent”). Pet. 19. In the
`916 IPR, the panel construed a similar limitation to mean “a light source
`containing two or more light emitting diodes (semiconductor sources),
`wherein at least one of the light emitting diodes is capable of having its
`pulse rate increased to increase a signal-to-noise ratio.” Pet. 21. Petitioner
`
`3 U.S. Patent No. 8,108,036 (Ex. 1064).
`4 U.S. Patent No. 8,725,226 (Ex. 1063).
`5 U.S. Patent Publication No. 2012/0197093 (Ex. 1005).
`6 Patent Owner first identified this limitation as the Pulse Rate Limitation in
`the Preliminary Response. Prelim. Resp. 8.
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`Patent 10,517,484 B2
`states that it supports this construction, but that it “does not believe this term
`requires construction because the prior art teaches it even under the
`construction [Patent Owner] proffered in IPR2019-00916.” Id. In the
`Decision to Institute, we determined that no claim construction was required.
`Dec. to Inst. 8–10. The Patent Owner Response contends that the pulse rate
`limitation needs no construction (PO Resp. 8–11) and, having reviewed the
`entire record, we agree that no claim construction is needed for the pulse rate
`limitation.
` “to identify an object” (claims 3 and 8) and “to detect an
`B.
`object” (claim 16)
`Patent Owner notes that claims 3 and 8 recite that “the wearable
`device is configured . . . to identify an object [,]” as distinguished from claim
`16, which recites that “the wearable device is configured . . . to detect an
`object.” PO Resp. 11–14. Patent Owner proposes that we construe the
`expression “to identify an object,” as used in claims 3 and 8 to mean “to
`recognize or establish an object as being a particular thing.” PO Resp. 13.
`Patent Owner proposes that we construe the term “to detect an object” to
`mean “to discover or notice the existence or presence of something.” Id. 14.
`Patent Owner cites dictionary definitions defining “identify” to mean “to
`recognize or establish as being a particular person or thing” (id. at 11) and
`“detect” to mean “to discover or notice the existence or presence of” (id. at
`13). Patent Owner contends that “the difference in claim language creates a
`presumption that identification which requires recognizing or establish an
`object is a particular thing differs from detection, which merely requires
`noticing an object’s presence.” Id. at 12.
`Petitioner states that “to the extent a construction of the term ‘detect
`an object is needed, a skilled person would understand it to mean ‘to
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`discover or determine the existence, presence, or fact of an object.’” Pet.
`Reply 19–20. Petitioner acknowledges that its proposed construction of
`“detect an object” is “generally consistent with [Patent Owner]’s proposed
`construction” but contends its construction is “more appropriate for system
`claims, given that a system can ‘discover’ or determine but not ‘notice’
`something.” Id. at 20.
`Petitioner contends that in the context of the ’484 patent, we should
`consider the expressions “identify an object” and “detect an object” to have
`the same meaning, i.e., “to discover or determine the existence, presence, or
`fact of an object.” Pet. Reply 20. According to Petitioner, notwithstanding
`the difference in the claim language, “identify” is used in the claims and the
`specification “simply to confirm that an object is present or not, rather than
`to take any action dependent on what the object is,” i.e., “the claims do not
`require the device to take any actions based on what an object is—they only
`require determining if something physical (an object) is present.” Id. at 20–
`21. Petitioner also states that many of Patent Owner’s citations to the ’484
`patent Specification in support of Patent Owner’s proposed construction are
`irrelevant to the claims because they involve actions not recited in the
`claims. Id. at 21.
`Petitioner’s argument that Patent Owner’s citations to the
`Specification concerning the terms “identify” and “detect” involve actions
`not recited in the claims does not change the fact that these different claim
`terms are presumed to have different meanings. The dictionary definitions
`of “detect” and “identify” are different. The use of the term “identify” in
`claims 3 and 8 and the use of a different term, i.e., “detect,” in claim 16
`indicates that the claims 3 and 8 mean something different from claim 16.
`Petitioner has not rebutted the presumption that different claim terms have
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`different meanings, whether or not these citations relate to unclaimed subject
`matter. See SimpleAir, Inc. v. Sony Ericsson Mobile Commc’ns AB, 820
`F.3d 419, 431 (Fed. Cir. 2016).
` Therefore, we decline to adopt Petitioner’s proposal to construe the
`terms “identify an object” and “detect an object” to have the same meaning.
`Instead, we construe these terms consistent with the dictionary definitions of
`“identify” and “detect,” i.e., we construe “to identify an object” to mean “to
`recognize or establish an object as being a particular thing,” and we construe
`“to detect an object” to mean “to discover or notice the existence or presence
`of something.” We address the specific implications of these constructions
`in our discussion of claims 3, 8, and 16.
`VI. ANALYSIS OF PRIOR ART CHALLENGES
`Introduction
`A.
`“In an [inter partes review], the petitioner has the burden from the
`onset to show with particularity why the patent it challenges is
`unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed.
`Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review
`petitions to identify “with particularity . . . the evidence that supports the
`grounds for the challenge to each claim”)). This burden of persuasion never
`shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics,
`Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in
`inter partes review).
`The question of obviousness is resolved on the basis of underlying
`factual determinations including: (1) the scope and content of the prior art;
`(2) any differences between the claimed subject matter and the prior art;
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`(3) the level of ordinary skill in the art7; and (4) objective evidence of
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
`
`Additionally, the obviousness inquiry typically requires an analysis of
`“whether there was an apparent reason to combine the known elements in
`the fashion claimed by the patent at issue.” KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398, 418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
`2006) (requiring “articulated reasoning with some rational underpinning to
`support the legal conclusion of obviousness”)); see In re Warsaw
`Orthopedic, Inc., 832 F.3d 1327, 1333 (Fed. Cir. 2016) (citing DyStar
`Textilfarben GmbH & Co. Deutschland KG v. C. H. Patrick Co., 464 F.3d
`1356, 1360 (Fed. Cir. 2006)).
` An obviousness analysis “need not seek out precise teachings
`directed to the specific subject matter of the challenged claim, for a court
`can take account of the inferences and creative steps that a person of
`ordinary skill in the art would employ.” KSR, 550 U.S. at 418; accord In re
`Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007). Petitioner
`cannot satisfy its burden of proving obviousness by employing “mere
`conclusory statements.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364,
`1380 (Fed. Cir. 2016). Instead, Petitioner must articulate a reason why a
`person of ordinary skill in the art would have combined the prior art
`references. In re NuVasive, 842 F.3d 1376, 1382 (Fed. Cir. 2016).
`A reason to combine or modify the prior art may be found explicitly
`or implicitly in “market forces; design incentives; the ‘interrelated teachings
`of multiple patents’; ‘any need or problem known in the field of endeavor at
`
`
`7 The level of ordinary skill in this case is discussed in the Decision to
`Institute and is uncontested. Dec. to Inst. 7–8.
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`the time of invention and addressed by the patent’; and the background
`knowledge, creativity, and common sense of the person of ordinary skill.”
`Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328–29 (Fed. Cir.
`2009) (quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418–21 (2007)).
`As part of determining whether a claim is obvious in light of the prior
`art, we consider any relevant evidence of secondary considerations of non-
`obviousness. See Graham, 383 U.S. at 17. Notwithstanding what the
`teachings of the prior art would have suggested to one of ordinary skill in the
`art at the time of the invention, the totality of the evidence submitted,
`including objective evidence of non-obviousness, may lead to a conclusion
`that the challenged claims would not have been obvious to one of ordinary
`skill. In re Piasecki, 745 F.2d 1468, 1471–72 (Fed. Cir. 1984). No such
`evidence is before us.
`Claims 1, 7, 15, 17 As Obvious Over Lisogurski and Carlson
`B.
`Petitioner states that claims 1, 7, and 15 contain overlapping
`limitations with identical or similar language. Pet. 38 n.7. Arguing that the
`distinctions between independent claims 1, 7, and 15 are inconsequential to
`patentability as variations that would be obvious to one of ordinary skill in
`the art, the Petition addresses these claims together and notes any difference
`at the start of its discussion of each limitation. Id. at 26–27. As discussed
`below, much of the dispute concerns claim limitation 1(l)(2), the “pulse rate
`limitation.” Patent Owner does not contest Petitioner’s contentions that the
`remaining claim limitations obvious over the cited prior art. See generally
`PO Resp. Having reviewed the claims and the evidence of record, we agree
`with Petitioner that variations in language of claim 1, 7, and 15 are
`inconsequential to patentability and treat claim 1 as exemplary. We also
`note that claim 15 does not recite the pulse rate limitation.
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`Lisogurski
`1.
`Lisogurski discloses a “physiological monitoring system [that]
`monitor[s] one or more physiological parameters of a patient . . . using one
`or more physiological sensors.” Ex. 1011, 3:44–46. The physiological
`sensors may include a “pulse oximeter [that] non-invasively measure[s] the
`oxygen saturation of a patient’s blood.” Id. at 3:62–64. The pulse oximeter
`includes “a light sensor that is placed at a site on a patient, typically a
`fingertip, toe, forehead, or earlobe.” Id. at 4:6–7. The light sensor “pass[es]
`light through blood perfused tissue and photoelectrically sense[s] the
`absorption of the light in the tissue.” Id. at 4:8–10. The light sensor emits
`“one or more wavelengths [of light] that are attenuated by the blood in an
`amount representative of the blood constituent concentration,” and may
`include red and infrared (IR) wavelengths of light. Id. at 4:42–48. Figure 3
`of Lisogurski is reproduced below.
`
`
`
`Figure 3 of Lisogurski is “a perspective view of an embodiment of a
`physiological monitoring system.” Id. at 2:23–25. The system includes
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`sensor 312, monitor 314, and multi-parameter physiological monitor 326.
`Id. at 17:35–36, 18:44–45. Sensor 312 includes “one or more light source[s]
`316 for emitting light at one or more wavelengths,” and detector 318 for
`“detecting the light that is reflected by or has traveled through the subject’s
`tissue.” Id. at 17:37–42. Sensor 312 may have “[a]ny suitable configuration
`of light source 316 and detector 318,” and “may include multiple light
`sources and detectors [that] may be spaced apart.” Id. at 17:42–45. Light
`source 316 may include “LEDs of multiple wavelengths, for example, a red
`LED and an IR [LED].” Id. at 19:25–27. Sensor 312 may be “wirelessly
`connected to monitor 314.” Id. at 17:57–59.
`Monitor 314 “calculate[s] physiological parameters based at least in
`part on data relating to light emission . . . received from one or more sensor
`units such as sensor unit 312.” Id. at 17:59–62. Monitor 314 includes
`“display 320 . . . to display the physiological parameters,” and “speaker 322
`to provide an audible . . . alarm in the event that a subject’s physiological
`parameters are not within a predefined normal range.” Id. at 18:3–10.
`Monitor 314 is “communicatively coupled to multi-parameter physiological
`monitor 326” (“MPPM 326”) and “may communicate wirelessly” with
`MPPM 326. Id. at 18:58–61. Monitor 314 may also be “coupled to a
`network to enable the sharing of information with servers or other
`workstations.” Id. at 18:62–65. Multi-parameter physiological monitor 326
`may also “calculate physiological parameters and . . . provide a display 328
`for information from monitor 314.” Id. at 18:49–52. MPPM 326 may also
`be “coupled to a network to enable the sharing of information with servers or
`other workstations.” Id. at 18:62–65. The remote network servers may also
`“be used to determine physiological parameters,” and may display the
`parameters on a remote display, display 320 of monitor 314, or display 328
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`of MPPM 326. Id. at 20:53–58. The remote servers may also “publish the
`data to a server or website,” or otherwise “make the parameters available to
`a user.” Id. at 20:58–60. Lisogurski discloses that the monitoring system
`shown in Figure 3, described above, “may include one or more components
`of physiological monitoring system 100 of FIG. 1.” Id. at 17:32–35.
`Lisogurski further discloses that although “the components of physiological
`monitoring system 100 . . . are shown and described as separate components
`. . . . the functionality of some of the components may be combined in a
`single component,” and “the functionality of some of the components . . .
`may be divided over multiple components.” Id. at 15:66–16:8. Figure 1 of
`Lisogurski is reproduced below.
`
`
`Figure 1 of Lisogurski
`Figure 1 of Lisogurski is a “block diagram of an illustrative physiological
`monitoring system.” Ex. 1011, 2:11–13. The system includes “sensor 102
`
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`and a monitor 104 for generating and processing physiological signals of a
`subject.” Id. at 10:44–46. Sensor 102 includes “light source 130 and
`detector 140.” Id. at 10:48–49. Light source 130 includes “a Red light
`emitting light source and an IR light emitting light source,” such as Red and
`IR emitting LEDs, with the IR LED emitting light with a “wavelength may
`be between about 800 nm and about 1000 nm.” Id. at 10:52–58. Detector
`140 “detect[s] the intensity of light at the Red and IR wavelengths,” converts
`them to an electrical signal, and “send[s] the detection signal to monitor 104,
`where the detection signal may be processed and physiological parameters
`may be determined.” Id. at 11:9–10, 11:20–23. Monitor 104 includes user
`interface 180, communication interface 190, and control circuitry 110 for
`controlling (a) light drive circuitry 120, (b) front end processing circuitry
`150, and (c) back end processing circuitry 170 via “timing control signals.”
`Id. at 11:33–38, Fig. 1. Light drive circuitry 120 “generate[s] a light drive
`signal . . . used to turn on and off the light source 130, based on the timing
`control signals.” Id. at 11:38–40. The light drive signal “control[s] the
`intensity of light source 130 and the timing of when [the] light source 130 is
`turned on and off.” Id. at 11:50–54. Front end processing circuitry 150
`“receive[s] a detection signal from detector 140 and provide[s] one or more
`processed signals to back end processing circuitry 170.” Id. at 12:42–45.
`Front end processing circuitry 150 also “synchronize[s] the operation of an
`analog-to-digital converter and a demultiplexer with the light drive signal
`based on the timing control signals.” Id. at 11:43–46.
`Back end processing circuitry 170 “use[s] the timing control signals to
`coordinate its operation with front end processing circuitry 150.” Id. at
`11:46–49. Back end processing circuitry 170 includes processor 172 and
`memory 174, and “receive[s] and process[es] physiological signals received
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`from front end processing circuitry 150” in order to “determine one or more
`physiological parameters.” Ex. 1011, 14:56–57, 14:60–64. Back end
`processing circuitry 170 is “communicatively coupled [to] user interface 180
`and communication interface 190.” Id. at 15:16–18. User interface 180
`includes “user input 182, display 184, and speaker 186,” and may include “a
`keyboard, a mouse, a touch screen, buttons, switches, [and] a microphone.”
`Id. at 15:19–22. Communication interface 190 allows “monitor 104 to
`exchange information with external devices,” and includes transmitters and
`receivers to allow wireless communications. Id. at 15:43–44, 15:48–57.
`Lisogurski teaches the physiological monitoring system may modulate the
`light drive signal to have a “period the same as or closely related to the
`period of [a] cardiac cycle.” Ex. 1011, 25:49–51. Thus, “[t]he system may
`vary parameters related to the light drive signal including drive current or
`light brightness, duty cycle, firing rate, . . . [and] other suitable parameters.”
`Id. at 25:52–55.
`Lisogurski discloses that a system may use various cardiac cycle
`modulation techniques to adjust the brightness of a light source controlled by
`the light drive signal, e.g., using a sinusoid or triangle wave whose period is
`related to cardiac pulse rate. Id. at 6:31–41. In addition, to improve the
`quality of the physiological parameter determination, cardiac cycle
`modulation may align the period of the modulated light drive signal with a
`particular point in the cardiac cycle, e.g., the diastolic period, the systolic
`period, the dicrotic notch, or any other suitable point. Id. at 6:41–46. The
`cardiac cycle modulation may also be based on empirical data concerning
`the determined physiological parameter. See id. at 6:53–7:3.
`Lisogurski also describes combining cardiac cycle modulation with
`drive cycle modulation. Ex. 1011, 6:29–31, 16:42–46. Drive cycle
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`modulation is “a technique to remove ambient and background signals.” Id.
`at 6:7–9. Drive cycle modulation operates by turning on a first light source,
`followed by a dark period, followed by a second light source, followed by a
`dark period, measuring the ambient light during the dark period and
`subtracting the ambient contribution from signal received during the first
`and second on periods. Id. at 6:11–19. Cardiac cycle modulation represents
`a lower frequency envelope function (about 1 Hz) on the higher frequency
`drive cycle (about 1 KHz). Id. at 6:26–30.
`Figure 2C of Lisogurski is reproduced below.
`
`Figure 2C of Lisogurski
`Figure 2C shows timing diagrams of drive cycle modulation and cardiac
`cycle modulation. Id. at 16:17–19. The period of the cardiac cycle
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`modulation, i.e., time period 260, may be on the order of 1 second and the
`period of drive cycle modulation 272 may be on the order of 1 msec. Id. at
`16:40–46. Plot 270 shows an illustrative portion of region 256, where both
`red light modulation 252 and IR modulation 254 are in an “on” portion of
`the cardiac modulation in the diastole. Id. at 16:33–38. Lisogurski explains:
`Time interval 272 may include a sequence of red “on” portion
`274, a first “off” portion 276, IR “on” portion 278, and a second
`“off” portion 280. The first “off” portion 276 and second “off”
`portion 280 may be used to determine the level of ambient
`light, noise, dark current, other suitable signals, or any
`combination thereof. The system may subtract the background
`or dark level from the levels received during red “on” portion
`274 and IR “on” period 278.
`Id. at 16:47–53. Lisogurski provides a similar discussion of region 258
`where red light modulation 252 is in an “off” portion of the cardiac cycle
`modulation and IR modulation is in an “on” portion of the cardiac cycle
`modulation. Id. at 16:54–17:10.
`As discussed above, Lisogurski discloses combining cardiac cycle and
`drive cycle modulation techniques, “[f]or example, cardiac cycle modulation
`may be an envelope on the order of 1 Hz superimposed on a 1 kHz sine
`wave drive cycle modulation.” Id. at 6:29–31. Lisogurski also states “[t]he
`system may use one or more cardiac cycle modulation techniques depending
`on the desired physiological parameter.” Id. at 9:12–14. As an example,
`Lisogurski discloses that “the system may alter the cardiac cycle modulation
`technique based on the level of noise, ambient light, other suitable reasons”
`and “[i]n some embodiments, the system may change from a modulated light
`output to a constant light output in response to noise, patient motion, or
`ambient light.” See id. at 9:45–60 (discussing options to reduce the effect of
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`noise that can be implemented during a cycle of the cardiac cycle
`modulation).
`Carlson
`2.
`Carlson concerns optical pulsoximetry used for non-invasive
`measurement of pulsation and oxygenation in arterial blood. Ex. 1009 ¶ 2.
`An articulated object of Carlson is “define optical and/or electronic means
`for increasing the Signal-to-Noise ratio (S/N) an