UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`
`APPLE INC. and FITBIT, INC.
`Petitioners
`
`v.
`
`VALENCELL, INC.
`Patent Owner
`
`__________________
`
`Case IPR2017-003171
`Patent 8,989,830
`__________________
`
`
`
`DECLARATION OF BRIAN W. ANTHONY, PH.D.
`IN SUPPORT OF PETITIONER APPLE INC.’S
`OPPOSITION TO PATENT OWNER’S MOTION TO AMEND
`
`
`
`
`
`Mail Stop “Patent Board”
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-145
`
`
`1 IPR2017-01553 has been joined to this current proceeding.
`
`
`
`
`
`APL1103
`Apple v. Valencell
`IPR2017-00317
`
`

`

`I. 
`II. 
`III. 
`IV. 
`V. 
`
`VI. 
`
`VII. 
`
`VIII. 
`
`TABLE OF CONTENTS
`
`Background .................................................................................................. 3 
`My Understanding of Legal Principles ........................................................ 5 
`Level of Ordinary Skill in the Art ............................................................. 10 
`Substitute Claims 26 and 35 Lack Reasonable Certainty .......................... 11 
`Overview of the Applied References ......................................................... 12 
`A.  Goodman ............................................................................................... 12 
`B.  Hicks ..................................................................................................... 13 
`C.  Asada .................................................................................................... 15 
`D.  Hannula ................................................................................................. 20 
`E.  Delonzor ............................................................................................... 22 
`F.  Han ........................................................................................................ 23 
`The Combination of Goodman and Han Renders Substitute Claims 21–24,
`27, 30–33, and 36 Obvious ........................................................................ 25 
`A.  The Combination of Goodman and Han Renders Substitute Claims 21
`and 30 Obvious ..................................................................................... 25 
`B.  The combination of Goodman and Han renders substitute claims 22,
`23, 31, and 32 obvious .......................................................................... 34 
`C.  The combination of Goodman and Han renders substitute claims 24
`and 33 obvious ...................................................................................... 34 
`D.  The combination of Goodman and Han renders substitute claims 27
`and 36 obvious ...................................................................................... 35 
`E.  The combination of Goodman and Han renders substitute claims 28
`and 37 obvious ...................................................................................... 37 
`The Combination of Goodman, Han, and Hicks Renders Substitute Claims
`25 and 34 Obvious ..................................................................................... 38 
`The Combination of Goodman, Han, Hannula, and Asada Renders
`Substitute Claims 26 and 35 Obvious ........................................................ 39 
`A.  The combination of Goodman, Han, Hannula, and Asada teaches or
`suggests “a light reflective material on at least a portion of one or both
`of the inner and outer surfaces of the [inner/first] layer” ..................... 39 
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`B.  The combination of Goodman, Han, Hannula, and Asada teaches or
`suggests that “the at least one optical detector comprises first and
`second optical detectors” ...................................................................... 39 
`C.  The combination of Goodman, Han, Hannula, and Asada discloses that
`“a signal processor, and wherein at least a portion of light reflected by
`the second optical detector is processed by the signal processor as a
`motion noise reference for attenuating motion noise from signals
`produced by the first optical detector” ................................................. 42 
`The Combination of Goodman, Han, and Delonzor Renders Substitute
`Claims 29 and 38 Obvious ......................................................................... 43 
`Conclusion ................................................................................................. 44 
`
`IX. 
`
`X. 
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`I, Dr. Brian W. Anthony, make this supplemental declaration to support the
`
`opposition to the motion to amend in IPR2017-00317. To that end, I hereby declare
`
`as follows:
`
`I.
`
`Background
`
`1.
`
`I am an expert in the relevant field of U.S. Patent No. 8,989,830 (the
`
`’830 patent). My qualifications and work experience are set forth in my opening
`
`declaration submitted in connection with the petition. See APL1003. A copy of my
`
`curriculum vitae was submitted as APL1004.
`
`
`2.
`
`I understand that the Board instituted an inter partes review of the
`
`’830 patent in IPR2017-00317. I have reviewed the Board’s institution decision
`
`and am familiar with all of the prior art supporting those grounds. The instituted
`
`grounds include:
`
`Instituted Grounds
`
`References
`
`Goodman
`
`Goodman and Hicks
`
`Goodman, Hannula, and Asada
`
`Claims
`
`1-4 and 11-14
`
`5 and 15
`
`6 and 16
`
`Goodman and Asada
`
`8, 9, 18, and 19
`
`Type
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`
`Instituted Grounds
`
`Goodman and Delonzor
`
`10 and 20
`
`I understand that Valencell, Inc. (“Patent Owner”) filed a contingent
`
`§ 103
`
`
`
`
`3.
`
`motion to amend in the inter partes review proceeding on September 22, 2017. In
`
`the motion to amend, Patent Owner proposes to substitute claims 21-38 in place of
`
`original claims 1-6, 8-16, and 18-20 of the ’830 patent only if each of original
`
`claims 1-6, 8-16, and 18-20 are found unpatentable. I have been asked to provide
`
`my technical review, analysis, insights, and opinions about the motion to amend.
`
`
`4.
`
`In reaching my opinions, I carefully reviewed the motion to amend,
`
`the petition for inter partes review of the ’830 patent, my opening declaration, and
`
`various exhibits, such as the ’830 patent and prior-art references. Specific to this
`
`declaration, I reviewed and refer to the following exhibits:
`
`Exhibit
`
`1001
`
`1002
`1003
`
`1005
`
`1007
`
`Description
`
`U.S. Patent No. 8,989,830 to LeBoeuf et al. titled “Wearable
`Light-Guiding Devices for Physiological Monitoring,” issued
`March 24, 2015
`U.S. Patent No. 8,989,830 File History
`Declaration of Dr. Brian W. Anthony in Support of Petition for
`Inter Partes Review of U.S. Patent No. 8,989,830
`Asada, H. et al. “Mobile Monitoring with Wearable
`Photoplethysmographic Biosensors,” IEEE Engineering in
`Medicine and Biology Magazine, May/June 2003; pp. 28-40
`U.S. Patent No. 4,830,014 to Goodman et al. titled “Sensor
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`
`Exhibit
`
`Description
`
`1008
`
`1009
`
`1010
`
`1104
`
`Having Cutaneous Conformance,” issued May 16, 1989
`U.S. Patent No. 6,745,061 to Hicks et al. titled “Disposable
`Oximetry Sensor,” issued June 1, 2004
`U.S. Patent No. 7,190,986 to Hannula et al. titled “Non-
`Adhesive Oximeter Sensor for Sensitive Skin,” issued March
`13, 2007
`U.S. Patent No. 5,797,841 to Delonzor et al. titled “Shunt
`Barrier in Pulse Oximeter Sensor,” issued August 25, 1998
`Hyonyoung Han et al., Development of a wearable health
`monitoring device with motion artifact reduced algorithm,
`International Conference on Control, Automation and Systems,
`IEEE (2007)
`
`
`5.
`
`I still agree with the contents of my opening declaration, and my
`
`
`
`opinions about substitute claims 21-38 are consistent with my opinions and factual
`
`findings in my opening declaration.
`
`II. My Understanding of Legal Principles
`
`I understand that my analysis requires an understanding of the scope
`6.
`
`of the ’830 patent claims and that the disclosures of the ’830 patent and the prior
`
`art are judged from the perspective of a person of ordinary skill in the art at the
`
`time of the purported invention. For the purposes of this declaration, I have been
`
`instructed to consider the time of the purported invention of the ’830 patent to be
`
`February 25, 2009, the earliest possible priority date for the ’830 patent. I note,
`
`however, that my opinions would not change even if all the relevant disclosures
`
`were judged from a later time period.
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`I understand that during an inter partes review, claims of an unexpired
`
`
`7.
`
`patent are to be given their broadest reasonable construction in light of the
`
`specification as would be understood by a person of ordinary skill in the relevant
`
`art. Unless otherwise noted, I have given the claim terms their plain and ordinary
`
`meaning as understood by a person of ordinary skill in the art at the time of the
`
`purported invention.
`
`
`8.
`
`I understand that a claim is invalid if it is anticipated or obvious. I
`
`understand that anticipation of a claim requires that every element of a claim is
`
`expressly or inherently disclosed in a single prior art reference. I understand that an
`
`anticipating reference need not use the exact terms of the claims, but must describe
`
`the patented subject matter with sufficient clarity and detail to establish that the
`
`claimed subject matter existed in the prior art and that such existence would be
`
`recognized by persons of ordinary skill in the field of the purported invention. I
`
`also understand that an anticipating reference must enable one of ordinary skill in
`
`the art
`
`to
`
`reduce
`
`the purported
`
`invention
`
`to practice without undue
`
`experimentation.
`
`
`9.
`
`I understand that a patent claim is invalid if the claimed invention
`
`would have been obvious to a person of ordinary skill in the art at the time of the
`
`purported invention. This means that even if all of the requirements of the claim
`
`cannot be found in a single prior art reference that would anticipate the claim, the
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`
`claim can still be invalid.
`
`
`10.
`
`I understand that an obviousness analysis involves comparing a claim
`
`to the prior art to determine whether the claimed invention would have been
`
`obvious to a person of ordinary skill in the art at the time of the purported
`
`invention in view of the prior art and in light of the general knowledge in the art as
`
`a whole. I also understand that obviousness is ultimately a legal conclusion based
`
`on underlying facts of four general types, all of which must be considered: (1) the
`
`scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the
`
`differences between the claimed invention and the prior art; and (4) any objective
`
`indicia of nonobviousness.
`
`
`11.
`
`I also understand that obviousness may be established by combining
`
`or modifying the teachings of the prior art. Specific teachings, suggestions, or
`
`motivations to combine any first prior art reference with a second prior art
`
`reference can be explicit or implicit, but must have existed before the date of the
`
`purported invention. I understand that prior art references themselves may be one
`
`source of a specific teaching or suggestion to combine features of the prior art, but
`
`that such suggestions or motivations to combine art may come from the knowledge
`
`of a person of ordinary skill in the art. Specifically, a rationale to combine the
`
`teachings of references may include logic or common sense available to a person
`
`of ordinary skill in the art.
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`I understand that a reference may be relied upon for all that it teaches,
`
`
`12.
`
`including uses beyond its primary purpose. I understand that though a reference
`
`may be said to teach away when a person of ordinary skill, upon reading the
`
`reference, would be discouraged from following the path set out in the reference,
`
`the mere disclosure of alternative designs does not teach away.
`
`
`13.
`
`I further understand that whether there is a reasonable expectation of
`
`success from combining references in a particular way is also relevant to the
`
`analysis. I understand there may be a number of rationales that may support a
`
`conclusion of obviousness, including:
`
` Combining prior art elements according to known methods to yield
`
`predictable results;
`
` Substitution of one known element for another to obtain predictable
`
`results;
`
` Use of a known technique to improve similar devices (methods, or
`
`products) in the same way;
`
` Applying a known technique to a known device (method, or product)
`
`ready for improvement to yield predictable results;
`
` “Obvious to try” – choosing from a finite number of identified,
`
`predictable solutions, with a reasonable expectation of success;
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
` Known work in one field of endeavor may prompt variations of it for use
`
`in either the same field or a different one based on design incentives or
`
`other market forces if the variations are predictable to one of ordinary
`
`skill in the art; and
`
` Some teaching, suggestion, or motivation in the prior art that would have
`
`led one of ordinary skill to modify the prior art reference or to combine
`
`prior art teachings to arrive at the claimed invention.
`
`
`14.
`
`I understand that it is not proper to use hindsight to combine
`
`references or elements of references to reconstruct the invention using the claims
`
`as a guide. My analysis of the prior art is made from the perspective of a person of
`
`ordinary skill in the art at the time of the purported invention.
`
`
`15.
`
`I understand that so-called objective considerations may be relevant to
`
`the determination of whether a claim is obvious should the Patent Owner allege
`
`such evidence. Such objective considerations can include evidence of commercial
`
`success caused by an invention, evidence of a long-felt need that was solved by an
`
`invention, evidence that others copied an invention, or evidence that an invention
`
`achieved a surprising result. I understand that such evidence must have a nexus, or
`
`causal relationship to the elements of a claim, in order to be relevant to the
`
`obviousness or non-obviousness of the claim. I am unaware of any such objective
`
`considerations having a nexus to the claims at issue in this proceeding.
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`I understand that for a reference to be used to show that a claim is
`
`
`16.
`
`obvious, the reference must be analogous art to the claimed invention. I understand
`
`that a reference is analogous to the claimed invention if the reference is from the
`
`same field of endeavor as the claimed invention, even if it addresses a different
`
`problem, or if the reference is reasonably pertinent to the problem faced by the
`
`inventor, even if it is not in the same field of endeavor as the claimed invention. I
`
`understand that a reference is reasonably pertinent based on the problem faced by
`
`the inventor as reflected in the specification, either explicitly or implicitly.
`
`
`17.
`
`I understand that 35 U.S.C. § 112(b) states that “[t]he specification
`
`shall conclude with one or more claims particularly pointing out and distinctly
`
`claiming the subject matter which the inventor or a joint inventor regards as the
`
`invention.” I understand this statute has been interpreted to require that the claims,
`
`when viewed in light of the specification and prosecution history, must inform
`
`those skilled in the art about the scope of the invention with reasonable certainty.
`
`III. Level of Ordinary Skill in the Art
` As I explained in my opening declaration, I understand that the person
`18.
`
`of ordinary skill in the art (“POSA”) is viewed at the time of invention. For the
`
`purpose of this declaration, I have evaluated the level of ordinary skill in the art as
`
`of February 25, 2009, the earliest possible priority date for the ’830 patent. Based
`
`on the disclosure of the ’830 patent, it is my opinion that a POSA at the relevant
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`time would have had at least a four-year degree in electrical engineering,
`
`mechanical engineering, biomedical engineering, optical engineering, or related
`
`field of study, or equivalent experience, and at least two years’ experience in
`
`academia or industry studying or developing physiological monitoring devices
`
`such as non-invasive optical biosensors. A POSA would have also been familiar
`
`with, for example, optical system design and signal processing. This description is
`
`approximate, and a higher level of education or skill might make up for less
`
`experience, and vice-versa.
`
` Based on my knowledge, skill, and experience, I have an
`19.
`
`understanding of the capabilities of a POSA. For example, from my industry
`
`experience, I am familiar with what an engineer designing non-invasive optical
`
`biosensors would have known and found predictable in the art. From teaching and
`
`supervising my post-graduate students, I also have an understanding of the
`
`knowledge that a person with this academic experience possesses. Furthermore, I
`
`possessed those capabilities myself at least as of February 25, 2009.
`
`IV. Substitute Claims 26 and 35 Lack Reasonable Certainty
` Substitute claims 26 and 35 recite “a signal processor” and it is
`20.
`
`unclear whether this signal processor is the same or different than the signal
`
`processor recited earlier in claims 21 and 30 from which claims 26 and 35
`
`respectively depend. Therefore, it is my opinion that a POSA would not have been
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`informed of the scope of claims 26 and 35 with reasonable certainty.
`
`V. Overview of the Applied References
`A. Goodman
` Goodman discloses a non-invasive optical biosensor that measures
`21.
`
`arterial oxygen saturation. (APL1007, 1:11-14.) The sensor “conforms to and with
`
`the cutaneous layer of the blood perfused portion of flesh upon which the sensor is
`
`placed.” (Id., 4:34-36.) For example, the sensors can be used with a finger, hand,
`
`toe, foot, or nose. (Id., 9:65-68, 10:7-9, Figures 4, 6A-6B.) In its use configuration,
`
`for example wrapped around a finger, the component layers assume a generally
`
`cylindrical or convex shape, or concave if viewed from the inside.
`
`
`
`
`
`
` As shown in Figure 2C, the sensor has a flexible layered substrate 22.
`
`structure, including a portion (24) having LEDs (25, 26) and a portion (14) having
`
`a photosensor (19). (Id., 8:49-56, 8:66-9:2, Figures 2C and 3A-3B.) The LEDs and
`
`photosensor are supported on a flexible tape layer (34) and an opaque vinyl strip
`
`(30). (Id., 9:20-25.) A second opaque vinyl strip (37) is placed over the photoactive
`
`elements with apertures (40, 41) to allow light to pass from the LEDs and to the
`
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`photosensor. (APL1007, 9:33-40.) A clear polyester layer (45) is disposed on the
`
`opaque vinyl layer (37) with an adhesive side (47) to bond to the skin. (Id., 9:46-
`
`50.) I have provided an annotated version of Figure 2C of Goodman below. A
`
`POSA would have understood that many of Goodman’s elements would have
`
`remained if configured as a wireless device. (See APL1015, p. 913.) And, indeed,
`
`these same components are described and claimed in the ’830 patent.
`
`APL1007, Figure 2C, Annotated
`
`
`
`B. Hicks
` Hicks
`23.
`
`is directed
`
`to a non-invasive optical biosensor
`
`for
`
`photoplethysmographic (PPG) pulse oximetry. (APL1008, 1:5-7.) The sensor
`
`device can be wrapped around a finger. (Id., 8:3-8.) The layer cross-section of
`
`Figure 6 annotated below shows that Hicks includes many of the same elements as
`
`Goodman. Hicks describes “a substantially clear flexible substrate that may be
`
`conformed about a portion of a patient’s tissue, such as a finger…allowing for
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`emitting and detecting light signals through this clear substrate.” (APL1008, 2:4-
`
`10.) The sensors include “at least one light emitter, such as a light emitting diode,
`
`and/or a light detector, such as a photodiode.” (Id., 2:14-15.) Further, “a
`
`compressible material layer may be disposed on the patient side surface” with
`
`“apertures aligned with each light emitter and/or light detector…allowing light to
`
`be emitted and/or detected through these apertures free from interference.” (Id.,
`
`2:35-41.) Hicks also describes “a light blocking layer applied to the top surface of
`
`the clear flexible substrate to minimize the effect of ambient light sources upon the
`
`sensor.” (Id., 2:42-45.)
`
`APL1008, Figure 6, Annotated
`
`
`
` Furthermore, Hicks describes that “the clear substrate 80 acts at least
`24.
`
`partially as a lens” and that “drops 110 of clear adhesive may also provide some
`
`focusing function for the LEDs 40, 42.” (APL1008, 9:36-42.) Or, “a separate lens
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`structure may be utilized if the refractive properties of the clear substrate 80 are not
`
`sufficient
`
`to properly direct/focus
`
`the
`
`light emitted/received by
`
`the
`
`emitters/detector 40, 42 and/or 38.” (Id., 13:42-46; see also Figure 15 illustrated
`
`below.) Lenses were standard optical elements that would have been well-known
`
`to a POSA and easily integrated into any optical device such as a non-invasive
`
`optical biosensor, if not already included.
`
`APL1008, Figure 15, Annotated
`
`
`
`C. Asada
` The Asada article discloses a non-invasive optical biosensor that can
`25.
`
`be used for health monitoring. (APL1005, p. 28.) More specifically, Asada
`
`describes iterations and advances of the pioneering “MIT Ring Sensor.” I
`
`personally became familiar with the Asada Ring Sensor around the time that I was
`
`developing an optical ring at Xcitex (see APL1003, ¶8), that would be used to
`
`capture user hand motion in order to control the user’s interaction with a computer.
`
`The Asada Ring Sensor “combines miniaturized data acquisition features with
`
`advanced photoplethysmographic (PPG) techniques to acquire data related to the
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`patient’s cardiovascular state.” (APL1005, p. 28.) For example, the Ring Sensor
`
`can monitor a patient’s heart rate, oxygen saturation, and heart rate variability,
`
`accounting for technical issues such as motion artifacts. (Id.) It is a “wearable ring
`
`pulse-oximeter solution, which measures the PPG as well as the arterial oxygen
`
`saturation.” (Id., 30.)
`
` The Ring Sensor built upon prior non-invasive optical biosensor
`26.
`
`technologies, for example, adhesive bandage devices and wired oximeters
`
`discussed in the State of the Art (APL1003, Section V) and Overview of the
`
`Applied References (above) sections, adapting them into a ring form-factor for
`
`continuous, wireless monitoring. In my opinion, the ring embodiment is a natural
`
`“cutting the wire” progression of the finger clip sensors commonly found in
`
`hospitals. Asada describes that the ring configuration is a logical choice for a
`
`wearable biosensor because a ring is small and generally worn without removal
`
`and the vasculature of the finger is located near the surface, which is beneficial for
`
`non-invasive optical biosensor sensor devices. (Id., 30.)
`
` An early Ring Sensor prototype included: an optical sensor unit
`27.
`
`having a light-emitting diode (LED) and a photodetector; and an on-board
`
`microcomputer for data acquisition, signal processing, and bi-directional radio-
`
`frequency (RF) communication. (APL1005, 34.) A subsequent iteration moved to a
`
`double ring configuration with an inner ring holding the sensor unit and an outer
`
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`ring that shields the sensor from ambient light and reduces motion artifacts. (Id.,
`
`Figure 10.)
`
`
`
`
` A later iteration included a sensor band that was “redesigned with the 28.
`
`use of bio-compatible elastic materials to better hold the LED’s and PD’s, maintain
`
`a proper level of pressure, optically shield the sensor unit, and secure the contact
`
`with the skin consistently in the face of finger motion (see Figure 11).” (Id., 35.) I
`
`have annotated Figure 11, below, which illustrates the components of the Ring
`
`Sensor (as they would have been understood by a POSA) using the terminology of
`
`the ’830 patent.
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`
`APL1005, Figure 11, Annotated
`
`
`
` Although Asada does not correlate its description with the reference
`29.
`
`numbers illustrated in Figure 11, this type of layered structure had been in the prior
`
`art for decades in similar form-factors. (APL1007, Figure 2B; APL1008, Figure 6;
`
`APL1009, Figure 1B; APL1104, Figure 10; APL1016, 3:42-46, Figures 1A-1B,
`
`24.) By way of example, U.S. Patent No. 5,226,417 to Swedlow et al. describes a
`
`layered adhesive wrap to be disposed about a finger, shown below in annotated
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`Figure 2. Swedlow discloses an outer bandage layer (21) coupled to LEDs (13, 16);
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`a photodetector (15) (APL1006, 5:48-49, 5:66-68, Figure 2); a clear polyethylene
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`layer (12) disposed over the LEDs and photodetector (id., 5:48-49, Figure 2); and
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`an adhesive, opaque white polypropylene layer (14) coupled to the clear layer, with
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`holes for the optical components (id., 5:42-51, Figure 2). A POSA would have
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`understood that these or similar features would have logically been included in
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`Asada’s device.
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`APL1006, Figure 2, Annotated
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`
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` Another iteration of the Ring Sensor included multiple LEDs and
`30.
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`multiple photodetectors – one for the main PPG signal, which would also include
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`noise, and one to serve as a floating-ground noise-only reference, as shown in
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`Figure 15. (APL1005, p. 36.) Asada describes that “[b]y using PD-B as a noise
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`reference, a noise cancellation filter can be built to eliminate the noise of PD-A
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`that correlates with the noise reference signal.” (Id., 33.) Representative
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`embodiments of Asada’s Ring Sensor are shown below in Figures 6, 8, and 15.
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`D. Hannula
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` Hannula discloses another non-invasive optical biosensor that uses 31.
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`LEDs to emit light into a well-perfused tissue bed and measures the light passing
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`through the tissue using a photodetector. (APL1009, 1:6-16.) As shown in
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`annotated Figures 1B and 1C below, Hannula includes typical components of these
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`sensors that are also disclosed in Goodman, such as: LEDs (111); a photodetector
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`(116); a transparent window (118) below the LEDs and photodetector; and
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`multiple laminated layers (112-114). (Id., 2:44-57, 3:9-13.)
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
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`APL1009, Figures 1B and 1C, Annotated
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`
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` Hannula also discloses that the LEDs (111) and photodetector (116)
`32.
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`can be surrounded by a reflective mask (117), which can be made of polyester or
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`polypropylene with a reflective metal surface. (APL1009, 2:58-9, 2:66-3:3, Figures
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`1B-1C.) “Reflective mask 117 reflects light from LED 111 (that has passed
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`through patient
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`tissue and exited near
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`the photodetector) back
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`toward
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`photodetector 116 like a mirror.” (Id., 2:58-62.) This increases the amount of LED
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`light that the photodetector receives from the patient’s tissue and also blocks
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`ambient light and LED light that may leak sideways through the laminated layers.
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`(Id., 2:63-66.)
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`
`E. Delonzor
` Delonzor discloses a non-invasive optical biosensor with elements
`33.
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`“preventing the shunting of light between the emitter and detector without passing
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`through blood-perfused tissue.” (APL1010, 1:6-9.) These non-invasive sensors can
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`be secured about a finger or ear, scatter light through the patient’s tissue, and
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`photoelectrically sense the absorption of light in the tissue. (Id., 1:15-19, 1:34-36.)
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` Delonzor also describes the well-known problems (discussed in the
`34.
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`State of the Art section of my opening declaration) of ambient light and shunting,
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`or shorting or short-circuiting, of light directly from the emitter to the
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`photodetector, which can distort or saturate the signal at the photodetector,
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`interfering with proper detection of oxygen saturation levels. (Id., 1:39-45.)
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`Delonzor describes a number of different types of “shunt barriers” (e.g., fiber
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`material, perforations or air gaps, and opaque material) that can be included in the
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`sensor devices to block light transmission directly from the emitter to the detector.
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`(Id., 3:7-48.) Although the examples show “sensors adapted to be wrapped onto a
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`digit, so that light is transmitted through the digit, it will be clear to those skilled in
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`the art that the design principles illustrated may be applied to any ‘transmittance’
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`or ‘reflectance’ sensors for pulse oximetry.” (Id., 3:54-57.) I agree that a POSA
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`would have known that components of transmittal and reflectance non-invasive
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`optical biosensors could readily be adapted for use in either type of device.
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`
`F. Han
` Han presents a wearable health monitoring device for obtaining a
`35.
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`photoplethysmography (PPG) signal. (APL1104, 1581.) Han recognizes that
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`movement by the wearer of the device introduces motion artifacts in the obtained
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`PPG signal, which distorts a heartbeat or pulsation signal contained therein. (Id..)
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`According to Han, the most well-known method for reducing motion artifacts is
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`active noise cancellation with an adaptive filter, but most implementations of this
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`method have a “large program size which is not adequate to wearable and portable
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`device[s].” (Id.) Han proposes an alternative active noise cancellation algorithm
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`with a small program size suitable for the presented wearable device. (Id.)
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` Han’s wearable device includes a finger band with a PPG sensor
`36.
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`“located on the inner layer of the band” and, attached to the finger band, on-board
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`electronics with a 3-axis accelerometer, microprocessor, and wireless module. (Id.,
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`1581-82, Figure 1.) Han’s electronics are configured to first pre-process a raw PPG
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`signal. (Id., 1582.) The raw PPG signal demands a low pass filter for reducing high
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`frequency noise and a high pass filter for rejecting a DC component of the PPG
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`signal to enhance the AC component. (Id.) Absent remaining noise, such as motion
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`noise, the AC component corresponds to the pulsatile component of the PPG
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`signal. The pulsatile component of the PPG signal is the signal of interest in Han
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`and is attributed to changes in blood volume that are synchronous with each
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`Case IPR2017-00317
`U.S. Pat. No. 8,898,830
`heartbeat. The high and low pass filters collectively form a band pass filter to
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`enhance this signal of interest.
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` Han’s on-board electronics are subsequently configured to process the
`37.
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`pre-processed PPG signal with the active noise cancellation algorithm to reduce
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`motion artifacts. (APL1104, 1582.) As shown in Figure 3 of Han (reproduced
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`below), the active noise cancellation algorithm implements a fourth order adaptive
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`filter and a digital filter to reconstruct a raw pulsation signal (sk) from the body
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`motion corrupted PPG signal (dk). (Id 1582, Figure 3.) More specifically, the
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`digital filter processes a measurable noise signal (xk) from the accelerometer to
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`produce body motion data (nk), which is then subtracted from the body motion
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`corrupted PPG signal (dk) to produce a reconstructed raw pulsation signal (ŝk). (Id.,
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`1582.) The fourth order adaptive filter determines the coefficients of the digital
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`filter by processing the measurable noise signal (xk) from the accelerometer and the
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`reconstructed raw pulsation signal (ŝk) according to equation (1) in Han. (Id., 1582-
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`83.) When employed, the active noise cancellation algorithm is capable of
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`removing artifacts from daily movement, including movements limited to the
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`finger, all the way up to walking or running. (APL1104, 1584.) Thus, Han’s active
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`noise cancellation algorithm is applicable in all types of settings, including for
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`monitoring patients in the hospital as well at home. (Id., 1581.)
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`Case I