`
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`______________
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`OMNI MEDSCI, INC.,
`Patent Owner.
`
`______________
`
`
`U.S. Patent No. 10,188,299
`
`IPR Case No.: IPR2020-00175
`
`
`______________
`
`
`
`PATENT OWNER’S NOTICE OF APPEAL TO THE
`U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT
`
`
`
`
`
`
`
`
`
`
`
`Case No.: IPR2020-00175
`Patent No.: 10,188,299
`
`
`
`Atty. Dkt. No.: OMSC0117IPR1
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`Notice is given, pursuant to 35 U.S.C. §§ 141 and 319 and 37 C.F.R. § 90.2(a),
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`that Omni MedSci, Inc. (“Omni”) appeals to the United States Court of Appeals for
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`the Federal Circuit from the Final Written Decision (“FWD”) entered on June 14,
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`2021 (Paper 26, attached) and from all underlying orders, decisions, rulings and
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`opinions that are adverse to Patent Owner, including, without limitation, those within
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`the Decision on Institution of Inter Partes Review, entered June 17, 2020 (Paper 11).
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`Per 37 C.F.R. § 90.2(a)(3)(ii), Omni further indicates that the issues on appeal
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`include, without limitation, the following issues.
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`First, the Board erred when it found the challenged claims unpatentable based
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`on Lisogurski alone. The claims require a “light source configured to increase signal
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`to noise ratio . . . by increasing a pulse rate.” The Board agreed with Petitioner that
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`Lisogurski only “sometimes increases SNR by increasing LED firing rate,” then
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`concluded, erroneously, “Lisogurski’s system, therefore, is ‘configured’ to increase
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`signal-to-noise by increasing LED pulse rate, even if it only does so some of the
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`time. See Hewlett-Packard Co. v. Mustek Systems, Inc., 340 F.3d 1314, 1326 (Fed.
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`Cir. 2003) (‘[A] prior art product that sometimes, but not always, embodies a
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`claimed method nonetheless teaches that aspect of the invention.’).” Paper 26, p. 36.
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`The legal basis for the Board’s finding was incorrect because Hewlett-Packard does
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`not apply to claims, like those of the ‘299 Patent, that require a specific
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`configuration. Ball Aerosol & Specialty Container, Inc. v. Ltd. Brands, Inc., 555
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`1
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`Case No.: IPR2020-00175
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`F.3d 984, 994 (Fed. Cir. 2009)(“reliance on cases that found infringement by
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`Atty. Dkt. No.: OMSC0117IPR1
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`accused products that were reasonably capable of operating in an infringing manner
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`is misplaced, since that line of cases is relevant only to claim language that specifies
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`that the claim is drawn to capability”).
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`Second, the Board erred when it combined Lisogurski’s teaching of cardiac
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`cycle modulation with Carlson’s teaching of modulation at 1000 Hz. The Board
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`found: “Lisogurski teaches switching the LED pulse rate from a cardiac cycle mode
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`(1 Hz pulse rate) to a second [cardiac cycle modulation] mode that reduces ambient
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`light noise, and Carlson teaches pulsing the LED at 1000 Hz to reduce ambient light
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`noise; that is, the combination teaches increasing signal-to-noise by increasing the
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`LED pulse rate from 1 Hz to 1000 Hz.” Paper 26, p. 41; see also id. at 41-42. The
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`Board did not address, or even consider, that increasing Lisogurski’s cardiac cycle
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`modulation firing rate from 1 Hz to 1000 Hz completely changes the principle of
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`operation of Lisogurski’s cardiac cycle modulation, which makes the combination
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`improper as a matter of law. MPEP 2143.01, § VI (“If the proposed modification or
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`combination of the prior art would change the principle of operation of the prior art
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`invention being modified, then the teachings of the references are not sufficient to
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`render the claims prima facie obvious.”) citing In re Ratti, 270 F.2d 810, 813
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`(C.C.P.A. 1959). The Board also did not address, or even consider, the fact that
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`Lisogurski already disclosed pulsing the LED at 1000 Hz (but not increasing that
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`pulse rate to increase SNR as claimed) within the “envelope” of cardiac cycle
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`Atty. Dkt. No.: OMSC0117IPR1
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`modulation at ~1 Hz. Thus, there was no basis for the Board’s combination of
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`Lisogurski with Carlson to find pulsing the LED at 1000 Hz.
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`Pursuant to 37 C.F.R. § 90.2(a)(1) and (a)(2), and as reflected in the attached
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`Certificate of Service, this Notice of Appeal is being electronically filed with the
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`Patent Trial and Appeal Board through the PRPS System and the United States Court
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`of Appeals for the Federal Circuit through the CM/ECF System along with the
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`requisite filing fee. A copy is also being mailed to the Office of the General Counsel
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`at the U.S. Patent and Trademark Office.
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`Dated: August 12, 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.
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`3
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`Case No.: IPR2020-00175
`Patent No.: 10,188,299
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`Atty. Dkt. No.: OMSC0117IPR1
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`CERTIFICATE OF FILING AND SERVICE
`
`The undersigned hereby certifies that on August 12, 2021 a complete and
`entire copy of PATENT OWNER’S NOTICE OF APPEAL was served by
`correspondence email address to 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
`(212) 839-7364
`
`Thomas A. Broughan III (Reg. No. 66,001)
`Sharon Lee (to be admitted pro hac vice)
`Sidley Austin LLP
`1501 K Street NW
`Washington, DC 20005
`(202) 736-8314
`
`Sharon Lee (pro hac vice to be submitted)
`sharon.lee@sidley.com
`(202) 736-8510
`
` I
`
` also certify that in addition to being filed electronically with the Board
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`through its PRPS System, the original of the foregoing Notice of Appeal is being
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`sent, pursuant to 37 C.F.R. § 104.2, via first-class mail on August 12, 2021 to the
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`United States Patent and Trademark Office at the following address:
`
`Office of the General Counsel
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`4
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`Case No.: IPR2020-00175
`Patent No.: 10,188,299
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`Atty. Dkt. No.: OMSC0117IPR1
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`I further certify that a copy of the foregoing Notice of Appeal was filed via
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`CM/ECF on August 12, 2021, with the United States Court of Appeals for
`
`the Federal Circuit.
`
`Dated: August 12, 2021
`
` /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.
`
`5
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`
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 26
`Entered: June 14, 2021
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.,
`Petitioner,
`v.
`OMNI MEDSCI, INC.,
`Patent Owner.
`
`IPR2020-00175
`Patent 10,188,299 B2
`
`
`
`
`
`
`
`
`
`Before GRACE KARAFFA OBERMANN, JOHN F. HORVATH, and
`SHARON FENICK, Administrative Patent Judges.
`Opinion for the Board filed by Administrative Patent Judge FENICK.
`
`Opinion Concurring filed by Administrative Patent Judge HORVATH.
`
`
`
`JUDGMENT
`Final Written Decision
`Determining All Challenged Claims Unpatentable
`35 U.S.C. § 318(a)
`
`
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`IPR2020-00175
`Patent 10,188,299 B2
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`I.
`
`INTRODUCTION
`A. Background
`Apple Inc. (“Petitioner”) filed a Petition requesting inter partes
`review of claims 7 and 10–14 (“the challenged claims”) of U.S. Patent No.
`10,188,299 B2 (Ex. 1001, “the ’299 patent”). Paper 1 (“Pet.”), 3. Omni
`MedSci Inc. (“Patent Owner”) filed a Preliminary Response. Paper 6
`(“Prelim. Resp.”). After considering the Petition, Preliminary Response, and
`additional briefing, we instituted inter partes review of all challenged claims
`on all grounds raised. Paper 11 (“Dec. Inst.”).
`Patent Owner filed a Response to the Petition (Paper 13, “PO Resp.”),
`Petitioner filed a Reply (Paper 15, “Pet. Reply”), and Patent Owner filed a
`Sur-reply (Paper 18, “PO Sur-reply”). An oral hearing was held on
`March 25, 2021, and the hearing transcript is included in the record. See
`Paper 25 (“Tr.”).
`We have jurisdiction under 35 U.S.C. § 6(b)(4). This is a Final
`Written Decision under 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the
`reasons set forth below, we find Petitioner has shown by a preponderance of
`evidence that claims 7 and 10–14 of the ’299 patent are unpatentable.
`B. Real Parties-in-Interest
`Petitioner and Patent Owner each identifies only itself as a real party-
`in-interest. Pet. x; Paper 4, 1.
`C. Related Matters
`Petitioner and Patent Owner identify the following as matters that
`could affect or be affected by a decision in this proceeding:
`Issued patents: U.S. Patent No. 9,651,533 and U.S. Patent No.
`9,164,032.
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`2
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`Litigation: Omni MedSci, Inc. v. Apple Inc., Action No. 2-19-cv-
`05673-YGR (N.D. Cal.); Omni MedSci, Inc. v. Apple Inc., Action No.
`2-19-cv-05924 (N.D. Cal.); Omni MedSci, Inc. v. Apple Inc., Action
`No. 2-18-cv-00429-RWS (E.D. Tex.) (terminated); and Omni MedSci,
`Inc. v. Apple Inc., Action No. 2-18-cv-00134-RWS (E.D. Tex.)
`(terminated).
`Inter partes review proceedings: IPR2019-00913 (terminated) and
`IPR2019-00916 (instituted).
`See Pet. xii–xiii; Paper 4, 1–2.
`D. Overview of the ’299 Patent
`The ’299 patent was filed on May 12, 2017, and claims priority to a
`utility application filed on December 17, 2013 and a provisional application
`filed on December 31, 2012. Ex. 1001, codes (22), (60), (63), 1:7–13. The
`’299 patent is directed to a system for measuring physiological parameters.
`Id. at code (54).
`The system, in one embodiment, includes a wearable measurement
`device for measuring physiological parameters. Id. at 6:48–50. This
`measurement device includes a light source including multiple
`semiconductor sources configured to generate an output optical beam in
`which a portion of the wavelengths of the output optical beam are of a near-
`infrared wavelength between 700 and 2500 nanometers. Id. at 6:50–55. A
`portion of this output optical beam is delivered to a sample and some portion
`of the beam reflected from or transmitted through the sample is received and
`processed. Id. at 6:55–63.
`A system including a wearable device is depicted in Figure 24 of the
`’299 patent, which is reproduced below.
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`Figure 24 is a schematic illustration of a medical measurement device
`that is part of a personal or body area network. Id. at 8:25–30. Wearable
`measurement device 2401 is a physiological measurement or blood
`constituent measurement device that includes processor 2402 and transmitter
`2403. Id. at 30:16–19. Communication link 2404 allows communication
`between measurement device 2401 and personal device 2405. Id. at 30:16–
`22. Personal device 2405, which may be a smart phone, optionally has a
`receiver, a transmitter, a display, a voice control, a speaker, one or more
`buttons or knobs, and/or a touch screen. Id. at 30:39–43. Personal device
`2405 stores, processes, displays, and transmits at least a portion of the output
`signal generated by wearable measurement device 2401. Id. at 30:37–39.
`Personal device 2405 also transmits some of the data or the processed output
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`signal over a wireless transmission link to internet or “cloud” 2407. Id.
`at 30:46–49. Internet or cloud 2407 may provide services including storage,
`processing, and retransmission of data to the originator or to another
`designated recipient such as a health care provider or doctor. Id. at 30:55–
`67.
`
`The light source of the measurement device can increase a signal-to-
`noise ratio by increasing either the LED intensity or pulse rate. Id. at code
`(57), 3:11–16. Additionally, “change detection schemes may be used, where
`the detection system captures the signal with the light source on and with the
`light source off. . . . Then, the signal with and without the light source is
`differenced. This may enable the sun light changes to be subtracted out.”
`Id. at 29:13–18.
`
`E. Illustrative Claims
`Claim 7 of the ’299 patent is the sole independent claim of the
`challenged claims and is reproduced below, with one limitation (the “pulse
`rate limitation”) italicized for emphasis.
`7. A system for measuring one or more physiological parameters
`comprising:
`a light source comprising a plurality of semiconductor sources
`that are light emitting diodes, each of the light emitting
`diodes configured to generate an output optical beam having
`one or more optical wavelengths, wherein at least a portion
`of the one or more optical wavelengths is a near-infrared
`wavelength between 700 nanometers and 2500 nanometers;
`a lens configured to receive a portion of at least one of the
`output optical beams and to deliver a lens output beam to
`tissue;
`a detection system configured to receive at least a portion of the
`lens output beam reflected from the tissue and to generate an
`output signal having a signal-to-noise ratio, wherein the
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`detection system is configured to be synchronized to the
`light source;
`a personal device comprising a wireless receiver, a wireless
`transmitter, a display, a microphone, a speaker, one or more
`buttons or knobs, a microprocessor and a touch screen, the
`personal device configured to receive and process at least a
`portion of the output signal, wherein the personal device is
`configured to store and display the processed output signal,
`and wherein at least a portion of the processed output signal
`is configured to be transmitted over a wireless transmission
`link;
`a remote device configured to receive over the wireless
`transmission link an output status comprising the at least a
`portion of the processed output signal, to process the
`received output status to generate processed data, and to
`store the processed data;
`wherein the output signal is indicative of one or more of the
`physiological parameters, and the remote device is
`configured to store a history of at least a portion of the one
`or more physiological parameters over a specified period of
`time;
`the system configured to increase the signal-to-noise ratio by
`increasing light intensity of at least one of the plurality of
`semiconductor sources from an initial light intensity and by
`increasing a pulse rate of at least one of the plurality of
`semiconductor sources from an initial pulse rate; and
`the detection system further configured to:
`generate a first signal responsive to light received while the
`light emitting diodes are off,
`generate a second signal responsive to light received while at
`least one of the light emitting diodes is on, and
`increase the signal-to-noise ratio by differencing the first signal
`and the second signal.
`Ex. 1001, 33:29–34:11, Certificate of Correction.
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`
`Claims 10 and 11 depend from claim 7, claim 12 depends from claim
`11, claim 13 depends from claim 12, and claim 14 depends from claim 13.
`Id. at 34:21–37.
`
`F. Evidence
`
`Reference
`Mannheimer
`
`US 5,746,206
`
`Lisogurski et al. US 9,241,676 B2
`
`Park et al.
`
`US 9,596,990 B2
`
`Date
`May 5, 1998
`
`May 31, 2012
`
`Nov. 6, 2013
`
`Carlson et al.
`
`US 2005/0049468 A1 Mar. 3, 2005
`
`Exhibit
`1008
`
`1011
`
`1010
`
`1009
`
`Petitioner also relies upon the Declaration of Brian Anthony, Ph.D.
`(Ex. 1003). Patent Owner relies upon two declarations of Duncan L.
`MacFarlane, Ph.D., P.E. (Ex. 2122; Ex. 2131). Petitioner cross-examined
`Dr. MacFarlane by deposition. Ex. 1065.
`G. Asserted Grounds of Unpatentability
`Petitioner asserts that the challenged claims would have been
`unpatentable on the following grounds:
`Claims
`Challenged
`7, 11–13
`12, 13
`10, 14
`
`References
`Lisogurski, Carlson
`Lisogurski, Carlson, Mannheimer
`Lisogurski, Carlson, Park
`
`35 U.S.C. §1
`103
`103
`103
`
`
`1 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011), amended 35 U.S.C. § 103 effective March 16, 2013. Because the
`’299 patent claims priority to a provisional filed prior to the effective date of
`the applicable AIA amendment, we refer to the pre-AIA version of § 103.
`
`7
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`IPR2020-00175
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`
`Claims
`Challenged
`142
`
`35 U.S.C. §1
`103
`
`References
`Lisogurski, Carlson, Park, Mannheimer
`
`
`
`II. ANALYSIS
`A. Legal Standards
`It is a petitioner’s burden to demonstrate unpatentability. See
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
`(Fed. Cir. 2015) (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d
`1316, 1326–27 (Fed. Cir. 2008)).
`A claim is unpatentable as obvious if “the differences between the
`claimed invention and the prior art are such that the subject matter as a
`whole would have been obvious at the time the invention was made to a
`person having ordinary skill in the art to which said subject matter pertains.”
`35 U.S.C. § 103(a) (2012). 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; (3) the level of skill in the art; and (4) objective
`evidence of nonobviousness.3 Graham v. John Deere Co. of Kansas City,
`383 U.S. 1, 17–18 (1966).
`
`
`2 Although Petitioner styles this ground as relating to both claims 10 and 14,
`claim 10 depends from claim 7, and the Petition does not provide any
`indication of what portion of claims 7 or 10 Petitioner asserts is taught or
`suggested by Mannheimer. Pet. 3, 60–66, 70; Inst. Dec. 3. Accordingly, we
`treat this ground as directed solely to claim 14.
`3 No argument or evidence concerning secondary considerations has been
`adduced in the current record.
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`Even if prior art references disclose all claim limitations when
`combined, there must be evidence to explain why a person of ordinary skill
`in the art would have combined the references to arrive at the claimed
`invention. Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342,
`1366–67 (Fed. Cir. 2012) (citing Innogenetics, N.V. v. Abbott Labs., 512
`F.3d 1363, 1374 (Fed. Cir. 2008) (holding that “some kind of motivation
`must be shown from some source, so that the [trier of fact] can understand
`why a person of ordinary skill would have thought of either combining two
`or more references or modifying one to achieve the patented [invention]”)).
`An invention “composed of several elements is not proved obvious merely
`by demonstrating that each of its elements was, independently, known in the
`prior art.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Rather,
`“it can be important to identify a reason that would have prompted a person
`of ordinary skill in the relevant field to combine the elements in the way the
`claimed new invention does.” Id.
`An obviousness determination “cannot be sustained by mere
`conclusory statements; instead, there must be some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.” Id. (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006));
`see In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1380 (Fed. Cir.
`2016).
`
`B. Level of Ordinary Skill in the Art
`Petitioner, relying on the testimony of Dr. Anthony, identifies a
`person of ordinary skill in the art (“POSITA”) as someone who “would have
`[had] a good working knowledge of optical sensing techniques and their
`applications, and familiarity with optical system design and signal
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`processing techniques.” Pet. 15; Ex. 1003 ¶ 37. Such a person would have
`obtained such knowledge through “an undergraduate education in
`engineering (electrical, mechanical, biomedical, or optical) or a related field
`of study, along with relevant experience studying or developing
`physiological monitoring devices . . . in industry or academia.” Pet. 15–16.
`Patent Owner does not comment on this definition or provide an alternative
`definition of a person of ordinary skill.
`We find Petitioner’s undisputed definition of the person of ordinary
`skill in the art to be consistent with the problems and solutions disclosed in
`the patent and prior art of record, and adopt it as our own. See, e.g., In re
`GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995).
`C. Claim Construction
`In inter partes reviews, we interpret a claim “using the same claim
`construction standard that would be used to construe the claim in a civil
`action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019). Under this
`standard, we construe the claim “in accordance with the ordinary and
`customary meaning of such claim as understood by one of ordinary skill in
`the art and the prosecution history pertaining to the patent.” Id. Only claim
`terms that are in controversy need to be construed and only to the extent
`necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan
`Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017).
`Initially, Petitioner requested construction of the terms “beam” and
`“lens,” and Patent Owner, in the Preliminary Response, requested
`construction of the pulse rate limitation. Pet. 18–19; Prelim. Resp. 10. In
`the Decision on Institution we determined that, for the purposes of
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`institution, no constructions were necessary. Dec. Inst. 18–19 (citing Nidec,
`868 F.3d at 1017).
`In its Response, Patent Owner contends that no claim construction is
`necessary for any term. PO Resp. 10. Petitioner does not further address the
`construction of “beam” or “lens” in its Reply, but does obliquely address the
`construction of the pulse rate limitation, casting Patent Owner’s arguments
`regarding patentability as “impos[ing] special requirements for how the
`claimed devices increase signal-to-noise ratio [SNR].” Reply 1. However,
`Petitioner does not describe or request a specific construction for the pulse
`rate limitation. Id. We address the parties’ arguments relating to the pulse
`rate limitation below, at Section II.D.2.i. With respect to claim construction,
`however, we determine that no constructions of “beam,” “lens,” or the pulse
`rate limitation are necessary to resolve the controversy before us.
`D. Patentability of Claims 7, 11, 12, and 13 over Lisogurski and Carlson
`Petitioner argues claims 7 and 11 are unpatentable over the
`combination of Lisogurski and Carlson. Pet. 20–60. Patent Owner argues
`that Lisogurski does not teach or suggest the pulse rate limitation. PO Resp.
`11–18; PO Sur-reply 1–11.
`1. Overview of the Prior Art
`a) Lisogurski
`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 measures 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
`
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`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 4:8–11. 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.
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`Figure 3 of Lisogurski is “a perspective view of a physiological
`monitoring system.” Id. at 2:23–25. The system includes 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 sources 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
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`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 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
`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.
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`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.
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`Figure 1 of Lisogurski is a “block diagram of an illustrative physiological
`monitoring system.” Id. at 2:11–13. The system includes “sensor 102 and
`monitor 104 for generating and processing physiological signals of a
`subject.” Id. at 10:44–46. Sensor 102 includes “light source 130 and
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`detector 140.” Id. at 10:48–49. Light source 130 includes “a Red light
`emitting source and an IR light emitting source,” such as Red and IR
`emitting LEDs, with the IR LED emitting light with a “wavelength [which]
`may be between about 800 nm and 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 11:38–41. 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
`provides 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. Backend 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.” Id. at 14:56–57, 14:60–64. Backend processing
`circuitry 170 is “communicatively coupled [to] use[r] 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.” Id. at 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 further teaches “the system may alter the cardiac
`cycle modulation technique based on the level of noise, ambient light, [and]
`other suitable reasons.” Id. at 9:46–48. Thus, “[t]he system may increase
`the brightness of the light sources in response to [any] noise to improve the
`signal-to-noise ratio.” Id. at 9:50–52. The system may also “change from a
`modulated light output to a constant light output in response to noise, patient
`motion, or ambient light.” Id. at 9:57–60.
`b) Carlson
`Carlson discloses an “optical pulsoximetry [device] used for non-
`invasive measurement of pulsation and oxygen saturation in arterial human
`or animal blood.” Ex. 1009 ¶ 2. The device measures the light “absorption
`of reduced (Hb)—and oxidized (HbO2) h[e]moglobin at two optical
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`wavelengths, where the relative absorption coefficients differ significantly.”
`Id. ¶ 3. Figure 2 of Carlson is reproduced below.
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`Figure 2 of Carlson is a schematic illustration of an ear clip sensor 1
`of a pulsoximeter device. Id. ¶¶ 33, 49. Sensor 1 includes light source 15,
`which transmits light beam 8 through a patient’s earlobe 2, and light detector
`11 to detect the transmitted light. Id. ¶ 49. Light source 15 emits light at
`two wavelengths—660 nm and 890 nm—and can consist of two LEDs. Id.
`¶ 50.
`Carlson’s pulsoximeter can be used to “survey the heath condition of
`a person or an animal [that] is mobile,” and is “not restricted for use in, e.g.,
`a hospital.” Id. ¶ 72. Carlson teaches that “standard pulsoximeter sensors
`suffer from signal instability and insufficient robustness versus
`environmental disturbances.” Id. ¶ 4. For example, when a sensor is worn
`by a person driving along a tree-lined avenue, the sensor will receive
`sunlight “at a certain frequency” such that “every time when passing a tree,
`sunlight is attenuated and between the trees sunlight is influencing the
`measurement of the pulsoximeter sensor.” Id. ¶ 68. To addres