`571-272-7822
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` Paper No. 7
`Entered: June 5, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`APPLE INC.
`Petitioner,
`
`v.
`
`VALENCELL, INC.
`Patent Owner.
`____________
`
`IPR2017-00317
`Patent 8,989,830 B2
`____________
`
`
`
`Before BRIAN J. McNAMARA, JAMES B. ARPIN, and
`SHEILA F. McSHANE, Administrative Patent Judges.
`
`McSHANE, Administrative Patent Judge.
`
`DECISION
`Instituting Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
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`IPR2017-00317
`Patent 8,989,830 B2
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`I. INTRODUCTION
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`A. Background
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`Apple Inc. (“Petitioner”) filed a Petition requesting inter partes
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`review of claims 1–6, 8–16, and 18–20 (“the challenged claims”) of U.S.
`
`Patent No. 8,989,830 B2 (Ex. 1001, “the ’830 patent”) pursuant to 35 U.S.C.
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`§§ 311–319. Paper 2 (“Pet.”). Valencell, Inc. (“Patent Owner”) filed a
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`Preliminary Response to the Petition. Paper 6 (“Prelim. Resp.”).
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`We have authority under 35 U.S.C. § 314(a), which provides that an
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`inter partes review may not be instituted “unless . . . the information
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`presented in the petition . . . shows that there is a reasonable likelihood that
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`the Petitioner would prevail with respect to at least 1 of the claims
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`challenged in the petition.”
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`We determine that Petitioner has demonstrated that there is a
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`reasonable likelihood that it would prevail with respect to at least one of the
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`challenged claims. For the reasons set forth below, we institute an inter
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`partes review of claims 1–6, 8–16, and 18–20.
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`B. Related Proceedings
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`The parties indicate that the ’830 patent is at issue in Valencell, Inc. v.
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`Apple Inc., Case No. 5:16-cv-00001 (E.D.N.C), and Valencell, Inc. v. Fitbit,
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`Inc., Case No. 5:16-cv-00002 (E.D.N.C). Pet. 3; Paper 5, 1. Patent Owner
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`indicates the ’830 patent is also at issue in Valencell, Inc. v. Bragi Store,
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`LLC, Case No. 5:16-cv-00895 (E.D.N.C.). Paper 5, 1.
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`
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`In addition to this Petition, Petitioner indicates that it filed another
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`inter partes review petition challenging claims of the ’830 patent (IPR2017-
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`00316), and also filed another inter partes review petition (IPR2017-00318)
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`2
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`IPR2017-00317
`Patent 8,989,830 B2
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`challenging claims of U.S. Patent No. 8,886,269 B2, which is the parent of
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`the ’830 patent. Pet. 3.
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`C. The ’830 Patent
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`
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`The ’830 patent is entitled “Wearable Light-Guiding Devices For
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`Physiological Monitoring” and issued on March 24, 2015 from an
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`application filed on September 12, 2014. Ex. 1001, [22], [45], [54]. The
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`’830 patent claims priority to U.S. Patent Application No. 14/184,364, filed
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`on February 19, 2014 (now U.S. Patent No. 8,886,269 B2), and U.S. Patent
`
`Application No. 12/691,388, filed on January 21, 2010 (now U.S. Patent
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`8,700,111). Id. at [63].
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`
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`The ’830 patent is directed to monitoring devices configured to be
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`attached to the body of a subject. Ex. 1001, Abstract. The monitoring
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`devices may include physiological sensors to measure, for example, heart
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`rate, pulse rate, breathing rate, and a variety of other physical parameters.
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`Id., 4:33–67. The sensors, for example, may be photoplethysmography
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`(“PPG”) sensors for measuring blood flow properties, such as blood oxygen
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`level. Id. at 3:67–4:5. The ’830 patent discloses various embodiments of
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`the monitoring devices, such as that depicted in Figures 22A and 22B,
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`reproduced below.
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`3
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`Patent 8,989,830 B2
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`Figure 22A is a top plan of an embodiment of monitoring device 70
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`configured to be attached to the finger of a subject, and Figure 22B is a
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`cross-sectional view of the monitoring device. Ex. 1001, 8:16–20. The
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`monitoring device that fits over the finger has outer body portion 72 that
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`may include a flex circuit, and base 50 secured to inner body portion 74 and
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`outer body portion 72. Id. at 28:1–10. Base 50 supports optical emitter 24,
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`optical detector 26, and optical noise detector 26´. Id. at 28:19–21. Layer of
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`cladding material 21 is applied to (or near) outer surface 74a of inner body
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`portion 74, as well as inner surface 74b, to serve as a light guide to deliver
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`light from optical emitter 24 to the finger and to collect light from the finger
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`and deliver it to optical detectors 26, 26´. Id. at 28:30–38. “[W]indows 74w
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`are formed in the cladding material 21 and serve as light-guiding interfaces
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`to the finger.” Id. at 28:44–46. The device also may be embodied in “a
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`patch, such as a bandage that sticks on a person’s body.” Id. at 11:53–58.
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`
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`The ’830 patent discloses an embodiment of the invention illustrated
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`in Figure 3, reproduced below.
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`4
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`Patent 8,989,830 B2
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`Figure 3 depicts an embodiment of monitoring device showing a side section
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`view of a headset with a light-guiding earbud. Ex. 1001, 7:7–9.
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`Earbud 30 includes optical detector 26 and optical emitter 24. Ex.
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`1001, 14:52–53. Cladding material 21 is used to confine light within light
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`guiding region 19. Id. at 14:60–63.
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`Claim 1, reproduced below, is illustrative of the challenged claims of
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`the ’830 patent.
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`1. A monitoring device configured to be attached to the body of a
`subject, comprising:
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`an outer layer and an inner layer secured together, the inner
`layer comprising light transmissive material, and having inner
`and outer surfaces;
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`a base secured to at least one of the outer and inner layers and
`comprising at least one optical emitter and at least one optical
`detector;
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`a layer of cladding material near the outer surface of the inner
`layer; and
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`at least one window formed in the layer of cladding material
`that serves as a light-guiding interface to the body of the
`
`
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`5
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`IPR2017-00317
`Patent 8,989,830 B2
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`subject, wherein the light transmissive material is in optical
`communication with the at least one optical emitter and the at
`least one optical detector, wherein the light transmissive
`material is configured to deliver light from the at least one
`optical emitter to the body of the subject along a first direction
`and to collect light from the body of the subject and deliver the
`collected light in a second direction to the at least one optical
`detector, wherein the first and second directions are
`substantially parallel.
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`Ex. 1001, 30:35–55.
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`D. Asserted Grounds of Unpatentability
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`
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`Petitioner asserts the following grounds of unpatentability:
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`Ground Claim(s)
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`§ 103
`
`§ 103
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`§ 103
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`1–4, 11–14
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`5, 15
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`6, 16
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`Reference(s)
`
`Goodman1
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`Goodman and Hicks2
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`Goodman, Hannula3, and Asada4
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`§ 103
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`8, 9, 18, 19
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`Goodman and Asada
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`§ 103
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`10, 20
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`Goodman and Delonzor5
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`Pet. 6.
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`II. ANALYSIS
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`A. Claim Construction
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`In an inter partes review, the Board interprets claim terms in an
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`unexpired patent according to the broadest reasonable construction in light
`
`
`1 U.S. Patent No. 4,830,014 (issued May 16, 1989) (Ex. 1007).
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`2 U.S. Patent No. 6,745,061 B1 (issued June 1, 2004) (Ex. 1008).
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`3 U.S. Patent No. 7,190,986 B1 (issued March 13, 2007) (Ex. 1009).
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`4 H. Harry Asada, Mobile Monitoring with Wearable
`Photoplethysmographic Biosensors, IEEE ENGINEERING IN MEDICINE AND
`BIOLOGY MAGAZINE, Vol. 22, Issue 3, May-June 2003. (Ex. 1005).
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`5 U.S. Patent No. 5,797,841 (issued August 25, 1998) (Ex. 1010).
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`6
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`Patent 8,989,830 B2
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`of the specification of the patent in which they appear. 37 C.F.R.
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`§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46
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`(2016) (upholding the use of the broadest reasonable interpretation
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`approach). Under that standard, and absent any special definitions, we give
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`claim terms their ordinary and customary meaning, as they would be
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`understood by one of ordinary skill in the art at the time of the invention.
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`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
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`Although the parties propose claim constructions for some terms, at
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`this juncture of the proceeding, we determine that it is not necessary to
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`provide an express interpretation of any term of the claims.
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`B. Alleged Obviousness of Claims 1–4 and 11–14 over Goodman
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` Petitioner contends that claims 1–4 and 11–14 would have been
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`obvious over Goodman. Pet. 25–42. To support its contentions, Petitioner
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`provides explanations as to how the prior art discloses each claim limitation.
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`Id. Petitioner also relies upon the Declaration of Brian W. Anthony, Ph.D.
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`(Ex. 1003) (“Anthony Declaration”) to support its positions. Patent Owner
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`counters that the prior art does not render the claims obvious because
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`Petitioner has not sufficiently disclosed the basis of obviousness for some
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`claims and Goodman fails to teach some claim limitations. Prelim. Resp.
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`30–40.
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`
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`At this stage of the proceedings, we are persuaded by Petitioner’s
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`explanation and evidence in support of the obviousness grounds asserted
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`under Goodman against claims 1–4 and 11–14. We begin our discussion
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`with a brief summary of Goodman, and then address the evidence, analysis,
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`and arguments presented by the parties.
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`
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`7
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`Patent 8,989,830 B2
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`1. Goodman (Ex. 1007)
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`Goodman generally discloses an optical biosensor that measures
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`arterial oxygen saturation. Ex. 1007, 1:11–14. The sensors can be
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`configured for use with fingertips, toes, hands or feet, as well as on the skin
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`of the nasal septum overlying the carotid cavity. Id. at 9:65–68, 10:7–9.
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`Figure 4, reproduced below, is a depiction of a sensor fastened over a
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`fingertip.
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`
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`Figure 4 depicts a digit with the distal ends of the sensor fastened over the
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`fingertip. Ex. 1007, 8:27–28, 9:60–61.
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`Goodman discloses an embodiment with a sensor that uses a flexible
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`adhesive strip, depicted in Figure 2C and reproduced below.
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`Figure 2C is an exploded view of an embodiment of a sensor with
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`identification of individual elements. Ex. 1007, 8:15–18. In the depicted
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`embodiment, the photo-active elements of the sensor substrate, that is,
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`element 24 which has a light source mounted to it, and element 14, which
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`8
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`Patent 8,989,830 B2
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`has a photo-sensor mounted to it, are fastened to opaque vinyl strip 10. Id.
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`at 8:50–52, 9:19–22. Second opaque tape, with strip 37 and adhesive layer
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`38, is placed over the photo-active elements with apertures 40 and 41 in strip
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`37. Id. at 9:32–37. Layer of clear polyester 45 is placed over the length of
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`the flexible adhesive strip, and a protective layer of release tape 50 that is in
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`place during manufacture and before use. Id. at 9:45–52.
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`2. Analysis
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`Petitioner contends that Goodman teaches or suggests a monitoring
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`device, as claimed, and refers to Figure 2C of Goodman, as annotated by
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`Petitioner, to show the correspondence of the recited limitations to
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`Goodman’s structures. See Pet. 15, 16, 25–42. Annotated Figure 2C of
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`Goodman is reproduced below.
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`
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`Figure 2C is a view of an embodiment of a sensor of Goodman with
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`Petitioner’s annotations shown in red. Pet. 16. As depicted, Petitioner
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`asserts that the “cladding” limitation of claim 1 is taught by opaque layer 40
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`of Goodman, the “outer” and “inner” layers are part of clear polyester layer
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`45, and the “optical emitter” and “optical detector” are taught by Goodman’s
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`light-emitting diodes (“LEDs”) 24 and photodetector 14. Id. at 26–28.
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`Petitioner relies upon Goodman’s disclosure that its “opaque tape layer (37)
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`‘is apertured at respective apertures 40, 41 . . . [t]hese apertures allow light
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`9
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`Patent 8,989,830 B2
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`to pass,’” for the teaching of the claim limitation that “at least one window
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`[is] formed in the layer of cladding material that serves as a light-guiding
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`interface to the body of the subject.” Id. at 29–30 (citing Ex. 1007, 9:39–40,
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`Figs. 2B, 2C). Petitioner alleges that this passage suggests to a person of
`
`ordinary skill that the rest of the non-apertured layer inhibits the passage of
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`light. Id. at 29 (citing Ex. 1003 ¶ 74).
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`The Petition refers to Goodman’s disclosure of the embodiment that
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`depicts the sensor applied to a finger. Pet. 31. In this configuration,
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`Petitioner asserts that “the light source is disposed approximately on an
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`opposite side of the body part being transmilluinated [sic] from the
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`detector.” Id. (citing Ex. 1007, 4:46–52, Figs. 4, 6A–6B; Ex. 1003 ¶ 78).
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`Petitioner, referring to the Anthony Declaration for further support, asserts
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`that a person of ordinary skill in the art
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`would have understood that in Goodman’s device, some of the
`light emitted from the LEDs through the bio-compatible
`window and into the body is emitted in a first direction, for
`example, approximately orthogonal to the LED’s light emitting
`surface. (Anthony Decl., ¶ 80.) As the emitted light is
`reflected and refracted within the patient’s body–often multiple
`times–the light changes directions. (Id.) Some of the emitted
`light will be received at the photodiode in a second direction,
`for example, approximately orthogonal to the photodiode’s
`light receiving surface. (Id.) These first and second directions
`are “substantially parallel,” as recited in claim 1, because the
`LEDs and photodiode are disposed approximately opposite
`each other. (Id.).
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`Pet. 32.
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`Dr. Anthony testifies that PPG measurements may be performed using
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`either transmission or reflective modes, one of ordinary skill in the art would
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`have been familiar with these modes, and that one mode could be adapted
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`for use with the other. Ex. 1003 ¶ 78 (citing Ex. 1013, 7–8; Ex. 1014, 405;
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`
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`10
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`IPR2017-00317
`Patent 8,989,830 B2
`Ex. 1015, 912). Mendleson6, referred to by Dr. Anthony to reflect the
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`knowledge of one of ordinary skill in the art, states that, “[i]n transmission
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`pulse oximetry, the sensor can be attached across a fingertip, foot, or
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`earlobe. In this configuration, the light emitting diodes (LEDs) and
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`photodetector (PD) in the sensor are placed on opposite sides of a peripheral
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`pulsating vascular bed.” Ex. 1015, 912. Petitioner asserts that a person of
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`ordinary skill in the art would have understood that “Goodman employs a
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`transmittal PPG configuration, as opposed to a reflective PPG
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`configuration,” for the relied-upon transmittal configurations. Pet. 31 (citing
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`Ex. 1003 ¶ 78).
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`Patent Owner argues that institution should be denied because the
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`Petitioner’s arguments and evidence are conclusory and fail to support that
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`Goodman teaches the limitation of claim 1 that the light delivered to the
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`optical detector is substantially parallel to the emitted light. Prelim. Resp.
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`30–35. Patent Owner refers to Goodman’s embodiment depicted in Figure
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`6B, arguing that when the adhesive strip containing the sensor is applied to a
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`nose, “the light leaving the emitter is largely perpendicular to the light being
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`received by the detector.” Id. at 32. Patent Owner also alleges that the same
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`deficiency in teaching applies to Goodman’s finger embodiment, because
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`Goodman is silent as to where the emitter and detector are located and in
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`order to determine whether the elements would emit and detect light in
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`parallel directions, “one would need to know the width of the finger and the
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`position of the emitter and detector along the length of the device.” Id. at
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`
`6 Y. Mendelson, A Wearable Reflectance Pulse Oximeter for Remote
`Physiological Monitoring, PROCEEDINGS OF THE 28TH IEEE EMBS ANNUAL
`INTERNATIONAL CONFERENCE, August 30–September 3, 2006; 912–915 (Ex.
`1015).
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`11
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`35. Patent Owner avers that “Petitioner (and its expert) only assumes that
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`some light might be parallel, but does not support the contention that the
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`sensor device necessarily surrounds the finger, for example providing for the
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`length of the device and the width of the patient’s finger.” Id. Patent Owner
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`also argues that other references in the Petition, specifically, Figure 6 of
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`Asada, suggest the light would not be substantially parallel. Id. at 33 (citing
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`Ex. 1018, Fig. 6).
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`Patent Owner refers to Goodman’s disclosure that its apertures
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`“conform the thickness of the photo-active substrates to the overall thickness
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`of the flexible adhesive strip,” so that the substrates “are ideally
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`indistinguishable in the tactile sense from the flexible adhesive strip itself.”
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`Prelim Resp. 22 (citing Ex. 1007, 9:39–45). With that, Patent Owner argues
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`that Goodman’s disclosures fail to support that its apertures serve as a light-
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`guide or that strip 37 confines light for delivery to the body and back to the
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`photosensor. Id.
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`Patent Owner additionally contends that Petitioner fails to provide
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`sufficient support for the grant of inter partes review because it fails to
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`provide sufficient evidence and detailed explanation of the basis of its
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`assertions, such as the alleged failure to provide evidence that the cladding
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`material operates to confine light within a light-guiding region. Prelim.
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`Resp. 21, 37. More specifically, it is alleged that the Petition fails to explain
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`how Goodman teaches a cladding material “near the outer surface of the
`
`inner layer” that operates to deliver light in a direction that is substantially
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`parallel. Id. Patent Owner additionally alleges that there are gaps in
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`Petitioner’s analysis, and that the Dr. Anthony’s declaration repeats attorney
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`argument, lacks analysis, and “is full of mere conclusions.” Id. at 37–40.
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`12
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`Patent Owner also refers to its innovations in biometrics wearables,
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`asserting that its sensors are more accurate than competitors’ products, and
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`that it has received industry recognition, numerous awards, and patents for
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`these innovations. Prelim. Resp. 9–10. Patent Owner also refers to its
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`licensing of its patent portfolio program with multiple licensing partners. Id.
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`at 10.
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`On this record, we are persuaded that Petitioner has provided
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`sufficient support that Goodman adequately teaches the limitations of claim
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`1. Our view, based upon the current record, is that Petitioner’s arguments
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`and evidence as to Goodman’s descriptions are consistent with the teaching
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`of the claim limitations, including the limitation of “deliver light from the at
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`least one optical emitter . . . along a first direction and . . . deliver the
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`collected light in a second direction . . . wherein the first and second
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`directions are substantially parallel.” Goodman discloses that in its finger
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`application (Ex. 1007, Fig. 4), the preferred configuration is the use of
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`elongated tape 35 formed into a butterfly design.7 See id., 9:25–32, Fig. 2B.
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`Considering Figures 2B and 4 of Goodman, and the use of the butterfly
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`design, the locations of the light source (LED) and photo-sensor appear to be
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`opposite of each other, which is consistent with Petitioner’s assertion that
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`the light source is disposed approximately on an opposite side of the body
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`part from the sensor. With this orientation, our view is that there is
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`sufficient support at this stage in the proceedings that, under Goodman’s
`
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`7 Although Patent Owner refers to Asada’s disclosures to support its
`assertion that other references suggest that the associated light would not be
`substantially parallel (Prelim. Resp. 33), Petitioner relies upon Goodman
`solely for this ground. See Pet. 30–32.
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`13
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`teachings, the “first direction” and “second direction” of the light is
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`substantially parallel.
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`
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`On this record, we also are not persuaded by Patent Owner’s view that
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`the Petition misapplies the term “cladding material,” and its support is
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`insufficient to demonstrate that the cladding material of Goodman operates
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`to deliver light in a direction that is substantially parallel to the direction in
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`which the light is emitted. The claim refers to the “at least one window
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`formed in the layer of cladding material that serves as a light-guiding
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`interface to the body of the subject,” and it is the window formed in the
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`cladding, and not the cladding only, that delivers the light in a manner
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`claimed, and it appears that Goodman discloses windows or apertures
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`situated in an opaque tape. See Ex. 1007, 9:33–40, Fig. 2C (apertures 40 and
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`41, opaque tape 37). Additionally, it appears that Goodman’s opaque layer
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`is used to block light, and its apertures “allow light to pass,” thereby
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`sufficiently supporting that the apertures in the opaque tape serve as a “light-
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`guiding interface.”
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`
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`Further, although Patent Owner generally refers to the commercial
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`successes of its innovations, there is no evidence presented in the
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`Preliminary Response of a nexus between the evidence and the merits of the
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`claimed invention, nor are there any arguments presented on the application
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`of objective indicia of nonobviousness. As such, at this juncture, we cannot
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`subscribe any weight to potential secondary considerations, to the extent that
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`Patent Owner intended to assert any.8
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`
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`Based on the record before us, we are persuaded that Petitioner has
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`demonstrated a reasonable likelihood of prevailing on its assertion that claim
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`8 This deficiency also applies to each of the other grounds considered
`below.
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`14
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`1 is obvious over Goodman. Independent claim 11 has similar limitations to
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`claim 1, and we also are persuaded that Petitioner has presented sufficient
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`evidence to demonstrate its obviousness over Goodman. Pet. 33–40. For
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`the dependent claims 2–4 and 12–14, we also are persuaded that Petitioner
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`has presented sufficient evidence to demonstrate a reasonable likelihood that
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`Goodman teaches all of the limitations of the claims based on the record
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`before us. See Pet. 40–42.
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`C. Alleged Obviousness of Claims 5 and 15 over Goodman and Hicks
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`
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`Petitioner contends that claims 5 and 15 would have been obvious
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`over Goodman and Hicks. Pet. 43–45. To support its contentions, Petitioner
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`provides explanations as to how the prior art discloses each claim limitation.
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`Id. Petitioner also relies upon the Anthony Declaration to support its
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`positions.
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`
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`On this record, we are persuaded by Petitioner’s explanation and
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`evidence in support of the obviousness grounds asserted under Goodman
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`and Hicks against claims 5 and 15. We begin our discussion with a brief
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`summary of Hicks, and then address the evidence presented.
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`1. Hicks (Ex. 1008)
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`
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`Hicks is directed to pulse oximetry sensors that can be used on
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`fingers. Ex. 1008, 1:5–7, 8:3–8. Hicks discloses “a substantially clear
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`flexible substrate that may be conformed about a portion of a patient’s
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`tissue, such as a finger . . . allowing for emitting and detecting light signals
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`through this clear substrate,” and “one or more LED’s 40, 42 are disposed on
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`a first surface of the finger and a photodetector 38 is disposed on an
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`opposing surface of the finger.” Id. at 2:4–10, 8:6–8. Hicks discloses “a
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`compressible material layer may be disposed on the patient side surface”
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`15
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`with “apertures aligned with each light emitter and/or light detector . . .
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`allowing light to be emitted and/or detected through these apertures free
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`from interference.” Id. at 2:35–41. Hicks also discloses that the clear
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`substrate may act partially as a lens with drops of clear adhesive used to
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`provide some focusing function for the LEDs, or a lens, such as a frensel
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`lens, may be formed integrally into the clear substrate to provide light
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`focusing. Id. at 9:38–42, 13:42–48.
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`2. Analysis
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`
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`Claims 5 and 15 recite the limitation of “the light transmissive
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`material comprises a lens region in optical communication with the at least
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`one optical emitter that focuses light emitted by the at least one optical
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`emitter.” Ex. 1001, 30:66–31:2, 32:14–17. Petitioner alleges that Hicks
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`teaches the use of a clear substrate that may act as a lens, or a separate lens
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`structure that may be used in conjunction with the clear substrate. Pet. 43–
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`44 (citing Ex. 1008, 9:38–40, 13:42–51). Petitioner contends that Goodman
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`and Hicks are directed to non-invasive optical bio-sensors and are from the
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`same field of endeavor. Id. at 43 (citing Ex. 1003 ¶ 99). Petitioner also
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`alleges that including Hicks’ lens structure with Goodman’s clear polyester
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`layer “would have simply been a combination of prior art elements
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`according to known methods to yield predictable results,” and would have
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`improved the function of Goodman’s device. Id. at 44 (citing Ex. 1003
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`¶ 101). As such, Petitioner avers that it would have been obvious to a
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`person of ordinary skill in the art to combine the teachings of Goodman and
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`Hicks. Id.
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`On this record, we are persuaded that Petitioner has provided
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`sufficient evidence and explanations as to how the prior art discloses each
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`claim limitation, as well as a sufficiently articulated rationale for combining
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`their teachings. Therefore, we determine that Petitioner has demonstrated a
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`reasonable likelihood that it will prevail on its assertion that claims 5 and 15
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`of the ’830 patent are obvious over Goodman and Hicks.
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`D. Alleged Obviousness of Claims 6 and 16 over
`Goodman, Hannula, and Asada and Claims 8, 9, 18, and 19 over Goodman
`and Asada
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`Petitioner contends that claims 6 and 16 would have been obvious
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`over Goodman, Hannula, and Asada, and claims 8, 9, 18, and 19 would have
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`been obvious over Goodman and Asada. Pet. 45–55. To support its
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`contentions, Petitioner provides explanations as to how the prior art
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`discloses each claim limitation. Id. Petitioner also relies upon the Anthony
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`Declaration to support its positions.
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`On this record, we are persuaded by Petitioner’s explanation and
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`evidence in support of the obviousness grounds asserted under Goodman,
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`Hannula, and Asada against claims 6 and 16, and those under Goodman and
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`Asada against claims 8, 9, 18, and 19. We begin our discussion with a brief
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`summary of Hannula and Asada, and then address the evidence, analysis,
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`and arguments presented.
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`1. Hannula (Ex. 1009)
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`Hannula discloses a non-invasive, optical biosensor that uses LEDs to
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`emit light into tissue and measures the light passing through the tissue using
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`a photodetector. Ex. 1009, 1:6–16, 2:44–47. Figures 1B and 1C are
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`reproduced below:
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`Figures 1B and 1C depict cross-section and detailed view, respectively, of an
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`embodiment of sensor. Ex. 1009, 2:26–32. As shown in Figures 1B and 1C,
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`Hannula discloses components of the sensors, such as LED 111,
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`photodetector 116, transparent window 118, and multiple laminated layers
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`112–114. Id. at 2:44–57, 3:9–13. Hannula also discloses that LED 111 and
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`photodetector 116 can be surrounded by reflective mask 117, which can be
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`made of polyester or polypropylene with a reflective metal surface. Id. at
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`2:58–59, 2:66–3:3, Figs. 1B and 1C. “Reflective mask 117 reflects light
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`from LED 111 (that has passed through patient tissue and exited near the
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`photodetector) back toward photodetector 116 like a mirror.” Id. at 2:58-62.
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`This increases the amount of LED light that the photodetector receives from
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`the patient’s tissue and also may assist in blocking ambient light and LED
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`light that may shunt through the laminated layers. Id. at 2:63–66.
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`2. Asada (Ex. 1005)
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`Asada discloses “miniaturized data acquisition features with advanced
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`photoplethysmographic (PPG) techniques to acquire data related to the
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`patient’s cardiovascular state.” Ex. 1005, 28. For example, a ring
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`configuration of the sensor may monitor a patient’s heart rate, oxygen
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`saturation, and heart rate variability, accounting for technical issues, such as
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`motion artifacts. Id. Asada describes a ring sensor prototype that includes
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`an optical sensor unit with an LED and a photodetector; and an onboard
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`microcomputer for data acquisition, signal processing, data acquisition,
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`filtering, and bi-directional radio-frequency (“RF”) communication. Id. at
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`30, 34. Asada’s Figure 11 is reproduced below.
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`Figure 11 of Asada depicts a ring sensor band that protects optical
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`components and hides wires from the outside environment. Ex. 1005, 35.
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`The ring prototype configuration uses bands to hold the sensor unit and
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`secure contact with the skin, as well as shield the unit. Id. at 34.
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`3. Analysis
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`Claims 6 and 16 recite the limitation of “a light reflective material on
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`at least a portion of one or both of the inner and outer surfaces of the inner
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`layer, wherein the at least one optical detector comprises a first and second
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`optical detectors, and further comprising a signal processor, and wherein a
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`portion of light reflected in by the light reflective material and detected by
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`the second optical director is processed by the signal processor as a motion
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`19
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`noise reference.” Ex. 1001, 31:3–10, 32:19–25. Petitioner alleges that
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`Hannula teaches the use of a light reflective material, and a person of
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`ordinary skill in the art would have had reason to modify Goodman’s
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`teachings in view of Hannula’s teachings to increase the amount of LED
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`light that the photodetector receives from the patient’s tissue. Pet. 46.
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`Petitioner also contends that Asada is from the same field of endeavor as
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`Goodman and Hannula, that is, they are directed to non-invasive optical bio-
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`sensors. Id. at 47. It is alleged that Goodman discloses that “motion
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`artifacts” are a common problem, and this concern would have led a person
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`of ordinary skill in the art to Asada, which discloses “measure[ing] the
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`finger motion with another sensor or a second PD and us[ing] it as a noise
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`reference for verifying the signal as well as for canceling the disturbance and
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`noise.” Id. at 47–48 (citing Ex. 1003 ¶ 108; Ex. 1005, 30; also citing Ex.
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`1005, 32–33, 37, Figs. 6 and 15). Petitioner refers to Asada’s on-board
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`signal processor, and alleges that, because Goodman discloses that “long
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`term, uninterrupted measurement” is desirable, a person of ordinary skill in
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`the art would have had reason to make Goodman’s system wireless, like the
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`Asada system. Id. at 48 (citing Ex. 1007, 2:33–35, Ex. 1003, ¶¶ 109, 110).
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`Dr. Anthony testifies that, although Asada device appears bulky (see Ex.
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`1005, Fig. 9), it is small in volume and mass, and one of ordinary skill in the
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`art would have understood that the device would have even less volume and
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`mass when transitioned to bulk manufacturing. Ex. 1003 ¶ 107.
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`Additionally, Dr. Anthony opines that the combination of the teachings of
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`Asada with Goodman’s teachings would yield predictable results, improve
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`the function of Goodman’s similar device, and would introduce desirable
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`redundancy. Id. ¶ 110. As such, Petitioner avers that it would have been
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`obvious to a person of ordinary skill in the art to combine the teachings of
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`Goodman, Hannula, and Asada. Pet. 48.
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`Claims 8 and 9 recite, respectively, that the monitoring device has
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`“signal processor” and “a transmitter configured to transmit signals
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`processed by the signal processor to a remote device.” Ex. 1001, 31:24–29.
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`Claims 18 and 19 recite similar respective limitations. Id. at 32:39–44.
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`Petitioner asserts that Asada teaches the use of signal processing and
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`bidirectional RF communication, with transmission to a cellular phone
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`through an RF link. Pet. 54–55 (citing Ex. 1005, 34).
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`Patent Owner argues that the Petition fails to address significant
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`differences between Goodman and Asada, and the effect of those differences
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`on reasons to combine their teachings. Prelim. Resp. 41. Patent Owner
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`asserts that those differences relate to the aspect of Goodman’s sensor
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`directed to eliminating motion artifacts by fastening its apparatus completely
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`to the patient’s skin; Asada alternatively uses reflective PPG, with some
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`motion, to achieve a more reliable signal. Id. at 42–4