`
`
`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Ammar Al-Ali
`In re Patent of:
`10,687,745 Attorney Docket No.: 50095-0045IP3
`U.S. Patent No.:
`June 23, 2020
`
`Issue Date:
`Appl. Serial No.: 16/835,772
`
`Filing Date:
`March 31, 2020
`
`Title:
`PHYSIOLOGICAL MONITORING DEVICES, SYSTEMS,
`AND METHODS
`
`DECLARATION OF DR. BRIAN W. ANTHONY, Ph.D.
`
`
`1
`
`APPLE 1003
`
`
`
`TABLE OF CONTENTS
`
`V.
`
`
`Background .................................................................................................. 11
`I.
`Level of Ordinary Skill in the Art ............................................................... 13
`II.
`Interpretations of the ’745 Patent Claims at Issue ....................................... 13
`III.
`IV. Overview of the Prior Art ............................................................................ 14
`A.
`Iwamiya ............................................................................................. 14
`B.
`Sarantos ............................................................................................. 15
`C.
`Venkatraman ..................................................................................... 16
`D.
`Shie .................................................................................................... 17
`E.
`Savant ................................................................................................ 18
`The Iwamiya-Sarantos Combination ........................................................... 19
`A. Analysis ............................................................................................. 19
`1.
`Claim 1 .................................................................................... 19
`2.
`Claim 2 .................................................................................... 32
`3.
`Claim 3 .................................................................................... 33
`4.
`Claim 5 .................................................................................... 33
`5.
`Claim 6 .................................................................................... 34
`6.
`Claim 8 .................................................................................... 35
`7.
`Claim 10 .................................................................................. 35
`8.
`Claim 11 .................................................................................. 36
`9.
`Claim 12 .................................................................................. 37
`10. Claim 14 .................................................................................. 38
`VI. The Iwamiya-Sarantos-Venkatraman Combination .................................... 39
`A. Analysis ............................................................................................. 39
`1.
`Claim 4 .................................................................................... 39
`2.
`Claim 15 .................................................................................. 40
`3.
`Claim 17 .................................................................................. 46
`4.
`Claim 19 .................................................................................. 47
`
`2
`
`
`
`Claim 20 .................................................................................. 47
`5.
`Claim 21 .................................................................................. 48
`6.
`Claim 22 .................................................................................. 50
`7.
`Claim 23 .................................................................................. 52
`8.
`Claim 24 .................................................................................. 54
`9.
`10. Claim 25 .................................................................................. 54
`11. Claim 26 .................................................................................. 56
`VII. The Sarantos-Shie Combination .................................................................. 56
`A. Analysis ............................................................................................. 56
`1.
`Claim 1 .................................................................................... 56
`2.
`Claim 2 .................................................................................... 62
`3.
`Claim 5 .................................................................................... 63
`4.
`Claim 6 .................................................................................... 65
`5.
`Claim 8 .................................................................................... 66
`6.
`Claim 10 .................................................................................. 67
`7.
`Claim 11 .................................................................................. 68
`8.
`Claim 13 .................................................................................. 70
`9.
`Claim 14 .................................................................................. 72
`10. Claim 15 .................................................................................. 72
`11. Claim 17 .................................................................................. 76
`12. Claim 19 .................................................................................. 76
`VIII. The Sarantos-Shie-Venkatraman Combination ........................................... 77
`A. Analysis ............................................................................................. 77
`1.
`Claim 3 .................................................................................... 77
`2.
`Claim 4 .................................................................................... 79
`3.
`Claim 15 .................................................................................. 80
`4.
`Claim 17 .................................................................................. 82
`5.
`Claim 19 .................................................................................. 83
`6.
`Claim 20 .................................................................................. 83
`
`3
`
`
`
`Claim 21 .................................................................................. 85
`7.
`Claim 22 .................................................................................. 86
`8.
`Claim 23 .................................................................................. 88
`9.
`10. Claim 24 .................................................................................. 89
`11. Claim 25 .................................................................................. 90
`12. Claim 26 .................................................................................. 92
`IX. The Sarantos-Shie-Savant ........................................................................... 93
`A. Analysis ............................................................................................. 93
`1.
`Claim 12 .................................................................................. 93
`Legal Principles ........................................................................................... 95
`A. Anticipation ....................................................................................... 95
`B.
`Obviousness ...................................................................................... 96
`
`X.
`
`
`
`
`
`
`4
`
`
`
`
`I, Brian W. Anthony, of Cambridge, MA, declare that:
`
`
`1. My name is Dr. Brian W. Anthony. I am an Associate Principal
`
`Research Scientist at the Institute of Medical Engineering & Science at
`
`Massachusetts Institute of Technology (MIT). I am also a Principal Research
`
`Scientist at MIT’s Mechanical Engineering department, Director of the Master of
`
`Engineering in Advanced Manufacturing and Design Program at MIT, Director of
`
`Health Technology at the MIT Center for Clinical and Translational Research, a
`
`Co-Director of the Medical Electronic Device Realization Center of the Institute of
`
`Medical Engineering & Science, and Associate Director of MIT.nano. My current
`
`curriculum vitae is attached and some highlights follow.
`
`2.
`
`I earned my B.S. in Engineering (1994) from Carnegie Mellon
`
`University. I earned my M.S. (1998) and Ph.D. (2006) in Engineering from MIT.
`
`My research focused on high-performance computation, signal processing, and
`
`electro-mechanical system design.
`
`3.
`
`In 1997, I co-founded Xcitex Inc., a company that specialized in
`
`video-acquisition and motion-analysis software. I served as the Chief Technology
`
`Officer and directed and managed product development until 2006. Our first demo
`
`product was an optical ring for human motion measurement used to capture user
`
`hand motion in order to control the user’s interaction with a computer. Many of
`
`the structural elements of our optical ring addressed the same system issues as
`
`5
`
`
`
`those described and claimed in the patent at issue. For example, our optical ring
`
`included multiple light emitting diodes, multiple photodetectors, techniques for
`
`modulation and synchronization, and noise reduction algorithms. We estimated
`
`human hand-motion based on how that motion changed the detected light. In our
`
`application, we did not try to eliminate motion artifact, we tried to measure it. In
`
`developing our ring, we considered well-known problems such as ambient light
`
`and noise. Motion Integrated Data Acquisition System (MiDAS) was our flagship
`
`video and data acquisition product which relied upon precise synchronization of
`
`multiple clocks for optical sensor and video acquisition, data acquisition, and
`
`external illumination.
`
`4.
`
`I joined MIT in 2006 and was the Director of the Master of
`
`Engineering in Advance Manufacturing and Design Program for over ten years.
`
`The degree program covers four main components: Manufacturing Physics,
`
`Manufacturing Systems, Product Design, and Business Fundamentals. Many of
`
`the courses, projects, and papers my students undertake involve technologies
`
`relevant to the patent at issue, for example, sensor devices including non-invasive
`
`optical biosensors.
`
`5.
`
`In 2011, I co-founded MIT’s Medical Electronic Device Realization
`
`Center (“MEDRC”) and currently serve as co-director. The MEDRC aims to
`
`create and deploy revolutionary medical technologies by collaborating with
`
`6
`
`
`
`clinicians, the microelectronics, and medical devices industries. We combine
`
`expertise in computation; communications; optical, electrical, and ultrasound
`
`sensing technologies; and consumer electronics. We focus on the usability and
`
`productivity of medical devices using, for example, image and signal processing
`
`combined with intelligent computer systems to enhance practitioners’ diagnostic
`
`intuition. Our research portfolio includes low power integrated circuits and
`
`systems, big data, micro electro-mechanical systems, bioelectronics, sensors, and
`
`microfluidics. Specific areas of innovation include wearable, non-invasive and
`
`minimally invasive optical biosensor devices, medical imaging, laboratory
`
`instrumentation, and the data communication from these devices and instruments
`
`to healthcare providers and caregivers. My experience with these devices is
`
`directly applicable to the technology in the patent at issue.
`
`6.
`
`I am currently the Co-Director of the Device Realization Lab at the
`
`Medical Electronic Device Realization Center at the Institute of Medical
`
`Engineering & Science at MIT. The Device Realization Lab designs instruments
`
`and techniques to sense and control physical systems. Medical devices and
`
`manufacturing inspection systems are a particular focus. We develop and combine
`
`electromechanical systems, complex algorithms, and computation systems to
`
`create instruments and measurement solutions for problems that are otherwise
`
`intractable.
`
`7
`
`
`
`7.
`
`The research of the Device Realization Lab focuses on product
`
`development interests cross the boundaries of computer vision, acoustic and
`
`ultrasonic imaging, large-scale computation and simulation, optimization,
`
`metrology, autonomous systems, and robotics. We use computation, and computer
`
`science, as methodology for attacking complex instrumentation problems. My
`
`work combines mathematical modeling, simulation, optimization, and
`
`experimental observations, to develop instruments and measurement solutions.
`
`8. My record of professional service includes recognitions from several
`
`professional organizations in my field of expertise.
`
`9.
`
`I am a named inventor on 10 issued U.S. patents. Most but not all of
`
`these patents involve physiological monitoring and other measurement
`
`technologies.
`
`10.
`
`I have published approximately 100 papers, and have received a
`
`number of best paper and distinguished paper awards. A number of papers that I
`
`have published relate to physiological monitoring and other measurement and
`
`instrumentation technologies.
`
`11.
`
`I have been retained on behalf of Apple Inc. to offer technical
`
`opinions relating to U.S. Patent No. 10,687,745 (“the ’745 patent,” EX1001) and
`
`prior art references relating to its subject matter. I have reviewed the ’745 Patent
`
`and relevant excerpts of the prosecution history of the ’745 Patent (EX1002). I
`
`8
`
`
`
`have also reviewed the following prior art references and materials, in addition to
`
`other materials I cite in my declaration:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EX1004: U.S. Pat. No. 8,670,819 (“Iwamiya”)
`
`EX1005: U.S. Pat. No. 9,392,946 (“Sarantos”)
`
`EX1006: U.S. Pub. No. 2014/0275854 (“Venkataraman”)
`
`EX1007: U.S. Pat. No. 6,483,976 (“Shie”)
`
`EX1008: U.S. Pat. No. 6,801,799 (“Mendelson-799”)
`
`EX1009: U.S. Pub. No. 2015/0018647 (“Mandel”)
`
`EX1010: U.S. Pub. No. 2009/0275810 (“Ayers”)
`
`EX1011: PCT. Pub. No. 2011/051888 (“Ackermans”)
`
`EX1012: U.S. Pat. No. 6,158,245 (“Savant”)
`
`EX1013: Design of Pulse Oximeters, J.G. Webster; Institution of
`
`Physics Publishing, 1997 (“Webster”)
`
`EX1014: U.S. Pub. No. 2009/0054112 (“Cybart”)
`
`EX1015: U.S. Pat. No. 5,893,364 (“Haar”)
`
`EX1016: U.S. Pat. No. 5,952,084 (“Anderson”)
`
`EX1019: U.S. Pub. No. 2009/0097129 (“Naito”)
`
`EX1020: U.S. Pub. No. 2006/0128869 (“Taima”)
`
`EX1021: Polymers and Plastic Resins Information,
`Engineering360, printed from
`https://www.globalspec.com/learnmore/materials_chemicals_adh
`
`9
`
`
`
`esives/plastics_elastomers_polymers/plastics_polymers on
`August 15, 2022
`
`EX1022: Methods and Approaches of Futures Studies, printed
`from http://crab.rutgers.edu/~goertzel/futuristmethods.html on
`August 15, 2022.
`
`
`
`
`12. Counsel has informed me that I should consider these materials
`
`through the lens of one of ordinary skill in the art related to the ’745 patent at the
`
`time of the earliest possible priority date of the ’745 patent, and I have done so
`
`during my review of these materials. The ’745 patent claims priority to an
`
`application filed July 2, 2015 (the “Critical Date”). Counsel has informed me that
`
`this Critical Date represents the earliest priority date to which the challenged
`
`claims of ’745 patent are possibly entitled, and I have therefore used that Critical
`
`Date in my analysis below.
`
`13.
`
`I have no financial interest in the party or in the outcome of this
`
`proceeding. I am being compensated for my work as an expert on an hourly basis.
`
`My compensation is not dependent on the outcome of these proceedings or the
`
`content of my opinions.
`
`14.
`
`In writing this Declaration, I have considered the following: my own
`
`knowledge and experience, including my work experience in the fields of
`
`mechanical engineering, computer science, biomedical engineering, and electrical
`
`engineering; my experience in teaching those subjects; and my experience in
`
`10
`
`
`
`working with others involved in those fields. In addition, I have analyzed various
`
`publications and materials, in addition to other materials I cite in my declaration.
`
`15. My opinions, as explained below, are based on my education,
`
`experience, and expertise in the fields relating to the ’745 patent. Unless otherwise
`
`stated, my testimony below refers to the knowledge of one of ordinary skill in the
`
`fields as of the Critical Date, or before. Any figures that appear within this
`
`document have been prepared with the assistance of Counsel and reflect my
`
`understanding of the ’745 patent and the prior art discussed below.
`
`I.
`
`Background
`16. The ’745 patent, entitled “Advanced Pulse Oximetry Sensor,”
`
`describes a “non-invasive, optical-based physiological monitoring system[.]”
`
`EX1001, Face, Abstract.
`
`17.
`
`Independent claim 1 of the ’745 patent is generally representative:
`
`1. A physiological monitoring device comprising:
`
`a plurality of light-emitting diodes configured to emit light in
`
`a first shape;
`
`a material configured to be positioned between the plurality
`
`of light-emitting diodes and tissue on a wrist of a user when the
`
`physiological monitoring device is in use, the material
`
`configured to change the first shape into a second shape by
`
`11
`
`
`
`which the light emitted from one or more of the plurality of
`
`light-emitting diodes is projected towards the tissue;
`
`a plurality of photodiodes configured to detect at least a
`
`portion of the light after the at least the portion of the light
`
`passes through the tissue, the plurality of photodiodes further
`
`configured to output at least one signal responsive to the
`
`detected light;
`
`a surface comprising a dark-colored coating, the surface
`
`configured to be positioned between the plurality of photodiodes
`
`and the tissue when the physiological monitoring device is in
`
`use, wherein an opening defined in the dark-colored coating is
`
`configured to allow at least a portion of light reflected from the
`
`tissue to pass through the surface;
`
`a light block configured to prevent at least a portion of the
`
`light emitted from the plurality of light-emitting diodes from
`
`reaching the plurality of photodiodes without first reaching the
`
`tissue; and
`
`a processor configured to receive and process the outputted
`
`at least one signal and determine a physiological parameter of
`
`the user responsive to the outputted at least one signal.
`
`12
`
`
`
`
`
`II. Level of Ordinary Skill in the Art
`18. Based on the foregoing and upon my experience in this area, a person
`
`of ordinary skill in the relevant art as of the Critical Date (a “POSITA”) would
`
`have been a person with a working knowledge of physiological monitoring
`
`technologies. The person would have had a Bachelor of Science degree in an
`
`academic discipline emphasizing the design of electrical, computer, or software
`
`technologies, in combination with training or at least one to two years of related
`
`work experience with capture and processing of data or information, including but
`
`not limited to physiological monitoring technologies. Alternatively, the person
`
`could have also had a Master of Science degree in a relevant academic discipline
`
`with less than a year of related work experience in the same discipline.
`
`19. Based on my experiences, I have a good understanding of the
`
`capabilities of a POSITA. Indeed, I have taught, participated in organizations, and
`
`worked closely with many such persons over the course of my career.
`
`20.
`
`I have performed my analysis through the lens of a POSITA as of the
`
`Critical Date.
`
`III.
`
`Interpretations of the ’745 Patent Claims at Issue
`21.
`I understand that, for purposes of my analysis in this inter partes
`
`review proceeding, the terms appearing in the patent claims should generally be
`
`13
`
`
`
`interpreted according to their “ordinary and customary meaning.” See Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). I understand that
`
`“the ordinary and customary meaning of a claim term is the meaning that the term
`
`would have to a person of ordinary skill in the art in question at the time of the
`
`invention.” Id. at 1313. I also understand that the person of ordinary skill in the
`
`art is deemed to read the claim term not only in the context of the particular claim
`
`in which the disputed term appears, but in the context of the entire patent,
`
`including the specification. Id.
`
`IV. Overview of the Prior Art
`A.
`Iwamiya
`22.
`Iwamiya discloses an “optical biological information detecting
`
`apparatus” which is a physiological monitoring device. EX1004, Abstract. For
`
`example, Iwamiya describes that the “optical biological information detecting
`
`apparatus” is provided in “a central portion of the back cover” of “a wristwatch”
`
`(i.e., facing the wearer’s wrist). EX1004, 5:54-66, FIG. 1. As shown in the
`
`following annotated FIG. 4 from Iwamiya, the device includes LEDs 6 (shown in
`
`green) that emit light (orange) that is reflected by the tissue of the wearer’s wrist
`
`(pink) and detected by photodiodes 9 (yellow).
`
`14
`
`
`
`
`
`EX1004, Detail of FIG. 4 (annotated)
`
`B.
`Sarantos
`23. Sarantos describes a “wristband-type wearable fitness monitor” that
`
`measures “physiological parameters” of the wearer, such as the person’s “heart
`
`rate” and “blood oxygenation levels.” EX1005, 2:5-14, 5:55-59, 7:12-14, 13:39-
`
`47. The monitor performs these measurements using a photoplethysmographic
`
`(PPG) sensor, which includes one or more light sources (e.g., LEDs) and an array
`
`of photodetectors. Id., 1:9-10, 43-47, 7:12-16, 15:23-43. Sarantos describes that
`
`when the monitor “is worn by a person in a manner similar to a wristwatch, the
`
`back face” of the monitor “may be pressed against the person's skin, allowing the
`
`light sources” of the PPG sensor “to illuminate the person’s skin.” Id., 1:48-51,
`
`7:12-23. The light “diffuses through the person's flesh and a portion of this light is
`
`15
`
`
`
`then emitted back” (i.e., reflected) “out of the person's skin in close proximity to
`
`where the light was introduced into the flesh.” Id., 7:24-28. The photodetector
`
`array of the PPG sensor measures the “intensity” of this reflected light, and
`
`provides signals representing the intensity to “control logic” of the monitoring
`
`device. EX1005, 2:5-14, 7:12-23, 13:39-47. The control logic can then calculate
`
`different physiological parameters based on characteristics of the reflected light
`
`signal. Id., 1:54-56, 7:12-23. For example, the person’s heart rate can be
`
`calculated based on “fluctuations in the amount of light from the light source that
`
`is emanated back out of the flesh” that correspond fluctuations in blood volume
`
`associated with each beat of the person’s heart. Id., 7:23-60.
`
`C. Venkatraman
`24. Venkatraman teaches a portable biometric monitoring device with a
`
`touchscreen display that can be worn on the wrist like a watch. EX1006, 12:16-21,
`
`15:19-26, 52:23-53:18. In particular, Venkatraman describes a "biometric
`
`monitoring device[] ... adapted to be worn or carried on the body of a user ...
`
`including [an] optical heart rate monitor" designed to "be a wrist-worn or arm-
`
`mounted accessory such as a watch or bracelet." EX1006, 37:29-33.
`
`Venkatraman's monitoring device is "small in size so as to be unobtrusive for the
`
`wearer" and "designed to be able to be worn without discomfort for long periods of
`
`time and to not interfere with normal daily activity." EX1006, 14:28-36.
`
`16
`
`
`
`Venkatraman device also includes a digital display with "uses capacitive touch
`
`detection" to display data acquired or stored locally on the wristwatch. EX1006,
`
`53:19-55:51.
`
`25. Venkatraman further discloses transmitting information wirelessly
`
`from its monitoring device to a secondary device such as a smartphone. EX1006,
`
`31:1-16, 57:20-53. Venkatraman also discloses that such a configuration allows the
`
`secondary device to act as a user interface for the wrist-worn wearable
`
`physiological device. EX1006, 57:42-44. Venkatraman further discloses that the
`
`secondary device (i.e., smartphone) can show various metrics regarding the user's
`
`health, and receive inputs through a touch-screen display. EX1006, 37:41-63,
`
`55:29-51, 57:20-58:9.
`
`D.
`Shie
`26. Shie describes a diffuser that has a "light diffusing and shaping
`
`advantages" and changes a first shape of light into a second shape. EX1007, 6:61-
`
`7:7. The diffuser includes a "plurality of surface micro-structures" that "are
`
`designed to homogenize light passing through" the diffuser "to produce a
`
`predetermined pattern of smoothly varying, non-discontinuous light exiting the"
`
`diffuser. EX1007, Abstract. Shie describes that the exiting light "is therefore
`
`altered according to both the macro-optical characteristic of the" diffuser "as well
`
`as the homogenizing characteristics of the micro-structures." Id.
`
`17
`
`
`
`E.
`Savant
`27. Savant, titled “High Efficiency Monolithic Glass Light Shaping
`
`Diffuser and Method of Making,” describes a “light shaping diffuser (LSD)” which
`
`“is a type of diffuser used in a variety of illuminating, imaging, and light projecting
`
`applications.” EX1012, 1:16-19. “A LSD is a transparent or translucent structure
`
`having an entrance surface, an exit surface, and light shaping structures formed on
`
`its entrance surface and/or in its interior.” Id., 1:19-22. The “light shaping
`
`structures diffract light passing through the LSD so that the beam of light emitted
`
`from the LSD's exit surface exhibits a precisely controlled energy distribution
`
`along horizontal and vertical axes.” Id., 1:30-33.
`
`28. Savant describes that “LSDs can be used to shape a light beam so that
`
`over 90% (and up to 95%-98%) of the light beam entering the LSD is directed
`
`towards and into contact with a target located downstream of the LSD.” Id., 1:34-
`
`37. “A LSD can be made to collect incoming light and either (1) distribute it over
`
`a circular area from a fraction of a degree to over 100°, or (2) send it into an almost
`
`unlimited range of elliptical angles.” Id., 1:37-40. Savant describes that LSDs
`
`“exhibit a high degree of versatility because they may be employed with light from
`
`almost any source, including LEDs, daylight, a tungsten halogen lamp, or an arc
`
`lamp.” Id., 1:49-51. LSD’s can also be used to “control the angular spread of
`
`transmitted light.” Id., 6:16-17.
`
`18
`
`
`
`V. The Iwamiya-Sarantos Combination
`A. Analysis
`1.
`Claim 1
`[1.0] A physiological monitoring device comprising:
`In the combination, Iwamiya discloses an “optical biological
`
`29.
`
`information detecting apparatus” which is a physiological monitoring device.
`
`EX1004, Abstract. For example, Iwamiya describes that the “optical biological
`
`information detecting apparatus” is provided in “a central portion of the back
`
`cover” of “a wristwatch” (i.e., facing the wearer’s wrist). EX1004, 5:54-66, FIG.
`
`1. As shown in the following annotated FIG. 4 from Iwamiya, the device includes
`
`LEDs 6 (shown in green) that emit light (orange) that is reflected by the tissue of
`
`the wearer’s wrist (pink) and detected by photodiodes 9 (yellow). Accordingly, the
`
`combination of Iwamiya and Sarantos renders obvious a “physiological monitoring
`
`device.”
`
`19
`
`
`
`EX1004, Detail of FIG. 4 (annotated)
`
`30. Therefore, the combination of Iwamiya and Sarantos renders obvious
`
`
`
`[1.0].
`
`[1.1] a plurality of light-emitting diodes configured to emit
`light in a first shape;
`In the combination, Iwamiya discloses “light emitting units 6” that are
`
`31.
`
`each “composed of a light emitting diode (LED).” EX1004, 6:7-11, 6:32-39. The
`
`light emitting units 6 are shown in green in the following annotated FIG. 3 from
`
`Iwamiya:
`
`20
`
`
`
`
`
`EX1004, Detail of FIG. 3 (annotated)
`
`32. The light emitting units 6 “emit observation light of a specific
`
`wavelength band to optically observe a skin tissue of a human body.” Id., 6:7-11.
`
`The emitted observation light is in a first shape characterized by the specific
`
`location of each light emitting unit, e.g., the “3 o'clock” and “9 o'clock” positions
`
`as shown in FIGS. 3 and 4 of Iwamiya. See id., 6:7-11, FIGS. 3-4.
`
`33. Therefore, the combination of Iwamiya and Sarantos renders obvious
`
`[1.1].
`
`21
`
`
`
`[1.2] a material configured to be positioned between the
`plurality of light-emitting diodes and tissue on a wrist of a
`user when the physiological monitoring device is in use, the
`material configured to change the first shape into a second
`shape by which the light emitted from one or more of the
`plurality of light-emitting diodes is projected towards the
`tissue;
`In the combination, Iwamiya describes that the physiological sensor
`
`34.
`
`includes “an annular light guide unit 7 that guides the observation light emitted
`
`from the light emitting units 6 and annularly diffuses and irradiates the observation
`
`light with respect to a skin H.” EX1004, 6:7-14, Fig. 4. The annular light guide
`
`unit 7 includes “a light guiding ring portion 11” formed “using a material such as
`
`transparent glass or a transparent resin with a high light transmitting property.”
`
`Id., 6:40-45. The annular light guide unit 7 also includes “a diffusion/irradiation
`
`ring portion 12” that is “formed in almost a ring shape, using a clouded or milky
`
`resin with a light diffusing property.” Id., 6:40-42, 7:4-6. The following annotated
`
`FIGS. 2 and 4 from Iwamiya show top and cross-section views of physical
`
`monitoring device the annular light guide unit 7 (annotated in teal).
`
`22
`
`
`
`EX1004, Detail of FIG. 2 (annotated)
`
`
`
`
`
`EX1004, Detail of FIG. 4 (annotated)
`
`35. Annular light guide unit 7 changes the shape of the light emitted from
`
`individual light emitting units 6 to an annular shape (a second shape) and causes
`
`the light to irradiate an annular portion of tissue. Id., 11:55-12:36. As shown in
`
`the following annotated FIG. 4 from Iwamiya, the light from the light emitting
`
`units (the orange arrows) irradiates “an irradiation area E” in the user tissue
`
`“having a ring shape” (shown in yellow). Id., 7:61-65:
`
`23
`
`
`
`
`
`EX1004, Detail of FIG. 4 (annotated)
`
`36. As previously discussed (see [1.0], above), Iwamiya’s physiological
`
`sensor in Figure 4 is a wristwatch. See, e.g., EX1004, 6:22-31. Therefore, annular
`
`light guide unit 7 is positioned between light emitting units 6 and tissue on the
`
`wrist, as shown in annotated FIG. 4 below:
`
`EX1004, Detail of FIG. 4 (annotated)
`
`
`
`24
`
`
`
`37. Therefore, the combination of Iwamiya and Sarantos renders obvious
`
`[1.2].
`
`[1.3] a plurality of photodiodes configured to detect at
`least a portion of the light after the at least the portion of the
`light passes through the tissue, the plurality of photodiodes
`further configured to output at least one signal responsive to
`the detected light;
`In the combination, Iwamiya describes that the physical monitoring
`
`38.
`
`device includes a plurality of photodiodes. EX1004, 14:36-41 (disclosing “plural
`
`light receiving units 9”), 8:20-23 (stating that each unit is “composed of a silicon
`
`photo diode”). The photodiodes are configured to detect light after the light passes
`
`through tissue and output a signal responsive to the detected light, which is used to
`
`determine a physiological parameter of a user. See EX1004, 9:28-32 (“the
`
`observation light emitted from the light emitting unit 6 is irradiated onto the skin H
`
`and the scattered light thereof is received by the light receiving unit 9” which
`
`“outputs a current signal according to the amount of received light”), 8:61-9:7
`
`(describing “convert[ing] a current signal output from the light receiving unit 9”
`
`into a “voltage signal” and then displaying resulting biological information).
`
`39. The following annotated FIG. 4 from Iwamiya shows that the light
`
`(shown as orange arrows) emitted by the light emission units 6 (in green) is
`
`reflected by the tissue H (in pink) and received by the photodiodes 9 (in yellow).
`
`25
`
`
`
`EX1004, Detail of FIG. 4 (annotated)
`
`40. Therefore, the combination of Iwamiya and Sarantos renders obvious
`
`
`
`[1.3].
`
`[1.4] a surface comprising a dark-colored coating, the
`surface configured to be positioned between the plurality of
`photodiodes and
`the
`tissue when
`the physiological
`monitoring device is in use,
`In the combination, Iwamiya describes a “light shielding frame 18”
`
`41.
`
`surrounding the photodiodes 9. EX1004, 8:38-47, FIG. 4. As shown in FIG. 4
`
`from Iwamiya, the light shielding frame 18 (shown in pink) is positioned between
`
`the photodiodes 9 (in yellow) and the tissue (in pink):
`
`26
`
`
`
`EX1004, Detail of FIG. 4 (annotated)
`
`
`
`42. Also in the combination, Sarantos disclose