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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Ammar Al-Ali
`In re Patent of:
`10,687,745 Attorney Docket No.: 50095-0045IP4
`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
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`

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`TABLE OF CONTENTS
`
`V.
`
`
`Background .................................................................................................. 10
`I.
`Level of Ordinary Skill in the Art ............................................................... 11
`II.
`Interpretations of the ’745 Patent Claims at Issue ....................................... 12
`III.
`IV. Overview of the Prior Art ............................................................................ 12
`A. Ackermans ......................................................................................... 12
`B.
`Savant ................................................................................................ 14
`C.
`Venkatraman ..................................................................................... 15
`D.
`Sarantos ............................................................................................. 16
`The Ackermans-Savant Combination .......................................................... 17
`A. Overview of the Combination ........................................................... 17
`B.
`Analysis ............................................................................................. 20
`1.
`Claim 1 .................................................................................... 20
`2.
`Claim 2 .................................................................................... 31
`3.
`Claim 5 .................................................................................... 32
`4.
`Claim 6 .................................................................................... 34
`5.
`Claim 8 .................................................................................... 37
`6.
`Claim 10 .................................................................................. 37
`7.
`Claim 11 .................................................................................. 38
`8.
`Claim 12 .................................................................................. 40
`9.
`Claim 15 .................................................................................. 41
`10. Claim 17 .................................................................................. 49
`11. Claim 19 .................................................................................. 49
`VI. The Ackermans-Savant-Venkatraman Combination ................................... 50
`A. Overview of the Combination ........................................................... 50
`B.
`Analysis ............................................................................................. 52
`1.
`Claim 3 .................................................................................... 52
`2.
`Claim 4 .................................................................................... 54
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`2
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`Claim 20 .................................................................................. 55
`3.
`Claim 21 .................................................................................. 58
`4.
`Claim 22 .................................................................................. 59
`5.
`Claim 23 .................................................................................. 61
`6.
`Claim 24 .................................................................................. 62
`7.
`Claim 25 .................................................................................. 63
`8.
`Claim 26 .................................................................................. 64
`9.
`VII. The Ackermans-Savant-Sarantos Combination .......................................... 64
`A. Overview of the Combination ........................................................... 64
`B.
`Analysis ............................................................................................. 71
`1.
`Claim 13 .................................................................................. 71
`2.
`Claim 14 .................................................................................. 73
`VIII. Legal Principles ........................................................................................... 74
`A. Anticipation ....................................................................................... 74
`B.
`Obviousness ...................................................................................... 75
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`3
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`I, Brian W. Anthony, of Cambridge, MA, declare that:
`
`
`1. My name is Dr. Brian W. Anthony. I am an Associate Principal
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`Research Scientist at the Institute of Medical Engineering & Science at
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`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
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`Co-Director of the Medical Electronic Device Realization Center of the Institute of
`
`Medical Engineering & Science, and Associate Director of MIT.nano. My current
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`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.
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`My research focused on high-performance computation, signal processing, and
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`electro-mechanical system design.
`
`3.
`
`In 1997, I co-founded Xcitex Inc., a company that specialized in
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`video-acquisition and motion-analysis software. I served as the Chief Technology
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`Officer and directed and managed product development until 2006. Our first demo
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`product was an optical ring for human motion measurement used to capture user
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`hand motion in order to control the user’s interaction with a computer. Many of
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`the structural elements of our optical ring addressed the same system issues as
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`those described and claimed in the patent at issue. For example, our optical ring
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`included multiple light emitting diodes, multiple photodetectors, techniques for
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`modulation and synchronization, and noise reduction algorithms. We estimated
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`human hand-motion based on how that motion changed the detected light. In our
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`application, we did not try to eliminate motion artifact, we tried to measure it. In
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`developing our ring, we considered well-known problems such as ambient light
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`and noise. Motion Integrated Data Acquisition System (MiDAS) was our flagship
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`video and data acquisition product which relied upon precise synchronization of
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`multiple clocks for optical sensor and video acquisition, data acquisition, and
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`external illumination.
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`4.
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`I joined MIT in 2006 and was the Director of the Master of
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`Engineering in Advance Manufacturing and Design Program for over ten years.
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`The degree program covers four main components: Manufacturing Physics,
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`Manufacturing Systems, Product Design, and Business Fundamentals. Many of
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`the courses, projects, and papers my students undertake involve technologies
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`relevant to the patent at issue, for example, sensor devices including non-invasive
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`optical biosensors.
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`5.
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`In 2011, I co-founded MIT’s Medical Electronic Device Realization
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`Center (“MEDRC”) and currently serve as co-director. The MEDRC aims to
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`create and deploy revolutionary medical technologies by collaborating with
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`clinicians, the microelectronics, and medical devices industries. We combine
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`expertise in computation; communications; optical, electrical, and ultrasound
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`sensing technologies; and consumer electronics. We focus on the usability and
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`productivity of medical devices using, for example, image and signal processing
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`combined with intelligent computer systems to enhance practitioners’ diagnostic
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`intuition. Our research portfolio includes low power integrated circuits and
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`systems, big data, micro electro-mechanical systems, bioelectronics, sensors, and
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`microfluidics. Specific areas of innovation include wearable, non-invasive and
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`minimally invasive optical biosensor devices, medical imaging, laboratory
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`instrumentation, and the data communication from these devices and instruments
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`to healthcare providers and caregivers. My experience with these devices is
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`directly applicable to the technology in the patent at issue.
`
`6.
`
`I am currently the Co-Director of the Device Realization Lab at the
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`Medical Electronic Device Realization Center at the Institute of Medical
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`Engineering & Science at MIT. The Device Realization Lab designs instruments
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`and techniques to sense and control physical systems. Medical devices and
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`manufacturing inspection systems are a particular focus. We develop and combine
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`electromechanical systems, complex algorithms, and computation systems to
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`create instruments and measurement solutions for problems that are otherwise
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`intractable.
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`6
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`7.
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`The research of the Device Realization Lab focuses on product
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`development interests cross the boundaries of computer vision, acoustic and
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`ultrasonic imaging, large-scale computation and simulation, optimization,
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`metrology, autonomous systems, and robotics. We use computation, and computer
`
`science, as methodology for attacking complex instrumentation problems. My
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`work combines mathematical modeling, simulation, optimization, and
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`experimental observations, to develop instruments and measurement solutions.
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`8. My record of professional service includes recognitions from several
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`professional organizations in my field of expertise.
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`9.
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`I am a named inventor on 10 issued U.S. patents. Most but not all of
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`these patents involve physiological monitoring and other measurement
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`technologies.
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`10.
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`I have published approximately 100 papers, and have received a
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`number of best paper and distinguished paper awards. A number of papers that I
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`have published relate to physiological monitoring and other measurement and
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`instrumentation technologies.
`
`11.
`
`I have been retained on behalf of Apple Inc. to offer technical
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`opinions relating to U.S. Patent No. 10,687,745 (“the ’745 patent,” EX1001) and
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`prior art references relating to its subject matter. I have reviewed the ’745 Patent
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`and relevant excerpts of the prosecution history of the ’745 Patent (EX1002). I
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`have also reviewed the following prior art references and materials, in addition to
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`other materials I cite in my declaration:
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`EX1004: U.S. Pat. No. 8,670,819 (“Iwamiya”)
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`EX1005: U.S. Pat. No. 9,392,946 (“Sarantos”)
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`EX1006: U.S. Pub. No. 2014/0275854 (“Venkataraman”)
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`EX1007: U.S. Pat. No. 6,483,976 (“Shie”)
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`EX1008: U.S. Pat. No. 6,801,799 (“Mendelson-799”)
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`EX1009: U.S. Pub. No. 2015/0018647 (“Mandel”)
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`EX1010: U.S. Pub. No. 2009/0275810 (“Ayers”)
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`EX1011: PCT. Pub. No. 2011/051888 (“Ackermans”)
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`EX1012: U.S. Pat. No. 6,158,245 (“Savant”)
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`EX1013: Design of Pulse Oximeters, J.G. Webster; Institution of
`
`Physics Publishing, 1997 (“Webster”)
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`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”)
`
`12. Counsel has informed me that I should consider these materials
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`through the lens of one of ordinary skill in the art related to the ’745 patent at the
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`time of the earliest possible priority date of the ’745 patent, and I have done so
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`during my review of these materials. The ’745 patent claims priority to an
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`application filed July 2, 2015 (the “Critical Date”). Counsel has informed me that
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`this Critical Date represents the earliest priority date to which the challenged
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`claims of ’745 patent are possibly entitled, and I have therefore used that Critical
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`Date in my analysis below.
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`13.
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`I have no financial interest in the party or in the outcome of this
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`proceeding. I am being compensated for my work as an expert on an hourly basis.
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`My compensation is not dependent on the outcome of these proceedings or the
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`content of my opinions.
`
`14.
`
`In writing this Declaration, I have considered the following: my own
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`knowledge and experience, including my work experience in the fields of
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`mechanical engineering, computer science, biomedical engineering, and electrical
`
`engineering; my experience in teaching those subjects; and my experience in
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`working with others involved in those fields. In addition, I have analyzed various
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`publications and materials, in addition to other materials I cite in my declaration.
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`15. My opinions, as explained below, are based on my education,
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`experience, and expertise in the fields relating to the ’745 patent. Unless otherwise
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`stated, my testimony below refers to the knowledge of one of ordinary skill in the
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`fields as of the Critical Date, or before. Any figures that appear within this
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`document have been prepared with the assistance of Counsel and reflect my
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`understanding of the ’745 patent and the prior art discussed below.
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`I.
`
`Background
`16. The ’745 patent, entitled “Advanced Pulse Oximetry Sensor,”
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`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 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
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`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.
`
`
`II. Level of Ordinary Skill in the Art
`18. Based on the foregoing and upon my experience in this area, a person
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`of ordinary skill in the relevant art as of the Critical Date (a “POSITA”) would
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`have been a person with a working knowledge of physiological monitoring
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`technologies. The person would have had a Bachelor of Science degree in an
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`academic discipline emphasizing the design of electrical, computer, or software
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`technologies, in combination with training or at least one to two years of related
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`work experience with capture and processing of data or information, including but
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`not limited to physiological monitoring technologies. Alternatively, the person
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`could have also had a Master of Science degree in a relevant academic discipline
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`with less than a year of related work experience in the same discipline.
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`19. Based on my experiences, I have a good understanding of the
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`capabilities of a POSITA. Indeed, I have taught, participated in organizations, and
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`worked closely with many such persons over the course of my career.
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`20.
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`I have performed my analysis through the lens of a POSITA as of the
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`Critical Date.
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`11
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`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
`
`interpreted according to their “ordinary and customary meaning.” See Phillips v.
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`AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). I understand that
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`“the ordinary and customary meaning of a claim term is the meaning that the term
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`would have to a person of ordinary skill in the art in question at the time of the
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`invention.” Id. at 1313. I also understand that the person of ordinary skill in the
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`art is deemed to read the claim term not only in the context of the particular claim
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`in which the disputed term appears, but in the context of the entire patent,
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`including the specification. Id.
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`IV. Overview of the Prior Art
`A. Ackermans
`22. Ackermans describes an optical sensor 10 for measuring the blood
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`oxygenation levels of a user. EX1011, Abstract, 1, 2-5. As shown in FIGS. 1 and
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`2 below, the optical sensor 10 includes “at least one light emitter (20) for emitting
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`light (21) directed to a part of the skin (50) of a patient and at least one photo-
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`detector (30) for detecting light (31) reflected from the skin (50). A housing (40)
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`for carrying the at least one light emitter (20) and the at least one photo-detector
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`(30) is provided, where the housing (40) has a contact area with the skin (50).”
`
`EX1011, Abstract, 4:22-25.
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`EX1011, FIG. 1 (annotated)
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`EX1011, FIG. 2 (annotated)
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`23.
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`In the example shown in FIG. 7, Ackermans’ optical sensor 10 is
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`implemented within a wristwatch for placement on a user at a tissue measurement
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`site. EX1011, 10:29-35.
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`EX1011, FIG. 7 (annotated)
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`
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`24. The frame 90 of the wristwatch is attachable to the skin 50 of a patient
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`
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`with an elastic band. EX1011, 10:29-35. The “optical sensor 10 is positioned at
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`the center of the frame” 90. Id. Sensor 10 can be used to obtain physiological
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`measurements such as blood oxygen levels (e.g., arterial oxygen saturation levels)
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`and heart rates. EX1011, 6:15-18, 1:8-18, 13:10-12 (claim 6). “Electrical signals
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`from the at least one photo-detector are processed [by electrical elements] in order
`
`to determine an oximetry value.” Id., 3:10-12, 8:25-9:2, 10:3-10.
`
`B.
`Savant
`25. Savant, titled “High Efficiency Monolithic Glass Light Shaping
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`Diffuser and Method of Making,” describes a “light shaping diffuser (LSD)” which
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`“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
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`having an entrance surface, an exit surface, and light shaping structures formed on
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`its entrance surface and/or in its interior.” Id., 1:19-22. The “light shaping
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`structures diffract light passing through the LSD so that the beam of light emitted
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`from the LSD's exit surface exhibits a precisely controlled energy distribution
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`along horizontal and vertical axes.” Id., 1:30-33. Savant describes that “LSDs can
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`be used to shape a light beam so that over 90% (and up to 95%-98%) of the light
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`beam entering the LSD is directed towards and into contact with a target located
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`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.,
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`1:37-40. Savant describes that LSDs “exhibit a high degree of versatility because
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`they may be employed with light from almost any source, including LEDs,
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`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.
`
`C. Venkatraman
`26. Venkatraman teaches a portable biometric monitoring device with a
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`touchscreen display that can be worn on the wrist like a watch. EX1006, 12:16-21,
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`15:19-26, 52:23-53:18. In particular, Venkatraman describes a "biometric
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`monitoring device[] ... adapted to be worn or carried on the body of a user ...
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`including [an] optical heart rate monitor" designed to "be a wrist-worn or arm-
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`mounted accessory such as a watch or bracelet." EX1006, 37:29-33.
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`Venkatraman's monitoring device is "small in size so as to be unobtrusive for the
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`wearer" and "designed to be able to be worn without discomfort for long periods of
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`time and to not interfere with normal daily activity." EX1006, 14:28-36.
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`Venkatraman device also includes a digital display with "uses capacitive touch
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`detection" to display data acquired or stored locally on the wristwatch. EX1006,
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`53:19-55:51.
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`27. Venkatraman further discloses transmitting information wirelessly
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`from its monitoring device to a secondary device such as a smartphone. EX1006,
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`31:1-16, 57:20-53. Venkatraman also discloses that such a configuration allows the
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`secondary device to act as a user interface for the wrist-worn wearable
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`physiological device. EX1006, 57:42-44. Venkatraman further discloses that the
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`secondary device (i.e., smartphone) can show various metrics regarding the user's
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`health, and receive inputs through a touch-screen display. EX1006, 37:41-63,
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`55:29-51, 57:20-58:9.
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`D.
`Sarantos
`28. Sarantos describes a “wristband-type wearable fitness monitor” that
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`measures “physiological parameters” of the wearer, such as the person’s “heart
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`rate” and “blood oxygenation levels.” EX1005, 2:5-14, 5:55-59, 7:12-14, 13:39-
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`47. The monitor performs these measurements using a photoplethysmographic
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`(PPG) sensor, which includes one or more light sources (e.g., LEDs) and an array
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`of photodetectors. Id., 1:9-10, 43-47, 7:12-16, 15:23-43. Sarantos describes that
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`when the monitor “is worn by a person in a manner similar to a wristwatch, the
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`back face” of the monitor “may be pressed against the person's skin, allowing the
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`light sources” of the PPG sensor “to illuminate the person’s skin.” Id., 1:48-51,
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`7:12-23. The light “diffuses through the person's flesh and a portion of this light is
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`then emitted back” (i.e., reflected) “out of the person's skin in close proximity to
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`where the light was introduced into the flesh.” Id., 7:24-28. The photodetector
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`array of the PPG sensor measures the “intensity” of this reflected light, and
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`provides signals representing the intensity to “control logic” of the monitoring
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`device. EX1005, 2:5-14, 7:12-23, 13:39-47. The control logic can then calculate
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`different physiological parameters based on characteristics of the reflected light
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`signal. Id., 1:54-56, 7:12-23. For example, the person’s heart rate can be
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`calculated based on “fluctuations in the amount of light from the light source that
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`is emanated back out of the flesh” that correspond fluctuations in blood volume
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`associated with each beat of the person’s heart. Id., 7:23-60.
`
`V. The Ackermans-Savant Combination
`A. Overview of the Combination
`29.
`In this combination, the optical sensor 10 of Ackermans is modified to
`
`incorporate a light-shaping diffuser, such as those taught by Savant, between its
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`emitters and the tissue measurement site. EX1011, Abstract, 4:22-25, FIG. 1;
`
`EX1012, 1:16-51, 6:16-17.
`
`30.
`
`I believe that a POSITA would have been motivated and found it
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`obvious to modify Ackermans to incorporate a light-shaping diffuser, such as those
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`taught by Savant, between its emitters and the tissue measurement site in order to
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`more precisely control the distribution of light from the emitters across the tissue
`
`measurement site and improve sensor performance. As described by Savant, a
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`light-shaping diffuser provides precise control over the shape of the exiting light.
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`EX1012, 1:37-40 (a light-shaping diffuser “can be made to collect incoming light
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`and either (1) distribute it over a circular area from a fraction of a degree to over
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`100°, or (2) send it into an almost unlimited range of elliptical angles”). Such
`
`precise control would have allowed Ackermans’ device to be calibrated to increase
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`the amount of reflected light received by the photodiodes by precisely controlling
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`the area of the tissue site being illuminated, thereby leading to more received light
`
`and a higher signal-to-noise (SNR) ratio. EX1011, Abstract, 4:22-25, FIG. 1;
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`EX1012, 1:16-51, 6:16-17. Use of a light-shaping diffuser would also have
`
`enabled different spatial configurations of photodiodes to be utilized in the optical
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`sensor by allowing the distribution of light to be modified based on the specific
`
`diffuser chosen as would be important for different designs and use scenarios. See
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`id.
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`31. Further, a I believe that a POSITA would have found it obvious to
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`modify Ackermans based on Savant’s teachings because doing so entails the use of
`
`known solutions to improve similar systems and methods in the same way. It is
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`my understanding that “when a patent ‘simply arranges old elements with each
`
`performing the same function it had been known to perform’ and yields no more
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`than one would expect from such an arrangement, the combination is obvious.”
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). I further believe that a
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`POSITA would have recognized that applying Savant’s teachings to augment
`
`Ackermans would have led to predictable performance enhancement without
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`significantly altering or hindering the functions performed by Ackermans’ system.
`
`32.
`
`In fact, I believe that a POSITA would have been motivated to
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`incorporate the well-known techniques of Savant into Ackermans to achieve the
`
`predictable benefits described in Savant. See, e.g., EX1012, 1:16-51, 6:16-17.
`
`Indeed, a POSITA would have had a reasonable expectation of success
`
`incorporating Savant’s teachings into Ackermans, because Savant teaches that
`
`light-shaping diffusers are widely applicable to “almost any [light] source,
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`including LEDs.” See EX1012, 1:49-51.
`
`33. Accordingly, for at least these reasons, augmenting Ackermans’
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`device based on the teachings of Savant would have been routine and
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`straightforward to a POSITA, and it would have been clear that such a combination
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`would predictably work and provide the expected results without undue
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`experimentation. Id.
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`B. Analysis
`1.
`Claim 1
`[1.0] A physiological monitoring device comprising:
`34. Ackermans describes an optical sensor 10 for measuring the blood
`
`oxygenation levels of a user. EX1011, Abstract, 1, 2-5. As shown in FIGS. 1 and
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`2 below, the optical sensor 10 includes “at least one light emitter (20) for emitting
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`light (21) directed to a part of the skin (50) of a patient and at least one photo-
`
`detector (30) for detecting light (31) reflected from the skin (50). A housing (40)
`
`for carrying the at least one light emitter (20) and the at least one photo-detector
`
`(30) is provided, where the housing (40) has a contact area with the skin (50).”
`
`EX1011, Abstract, 4:22-25.
`
`
`
`EX1011, FIG. 1 (annotated)
`
`20
`
`

`

`EX1011, FIG. 2 (annotated)
`In the example shown in FIG. 7, Ackermans’ optical sensor 10 is
`
`35.
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`implemented within a wristwatch for placement on a user at a tissue measurement
`
`
`
`site. EX1011, 10:29-35.
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`
`
`
`
`EX1011, FIG. 7 (annotated)
`
`
`
`36. The frame 90 of the wristwatch is attachable to the skin 50 of a patient
`
`with an elastic band. EX1011, 10:29-35. The “optical sensor 10 is positioned at
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`21
`
`

`

`the center of the frame” 90. Id. Sensor 10 can be used to obtain physiological
`
`measurements such as blood oxygen levels (e.g., arterial oxygen saturation levels)
`
`and heart rates. EX1011, 6:15-18, 1:8-18, 13:10-12 (claim 6). “Electrical signals
`
`from the at least one photo-detector are processed [by electrical elements] in order
`
`to determine an oximetry value.” Id., 3:10-12, 8:25-9:2, 10:3-10. Accordingly,
`
`Ackermans renders obvious “a wrist-worn physiological monitoring device
`
`configured for placement on a user at a tissue measurement site.”
`
`37. Therefore, the combination of Ackermans and Savant renders obvious
`
`[1.0].
`
`[1.1] a plurality of light-emitting diodes configured to emit
`light in a first shape;
`38. As explained above with respect to [1.0], Ackermans describes an
`
`optical sensor 10 that includes “at least one light emitter (20) for emitting light (21)
`
`directed to a part of the skin (50) of a patient and at least one photo- detector (30)
`
`for detecting light (31) reflected from the skin (50).” EX1011, Abstract, 4:22-25.
`
`39.
`
`In more detail, Ackermans’ optical sensor 10 includes a light emission
`
`source (emitter 20 with housing 46) comprising a plurality of emitters in the form
`
`of LEDs that emit light at different wavelengths. EX1011, 6:1-8. These LEDs are
`
`configured to irradiate the tissue measurement site by emitting light 21 towards the
`
`tissue measurement site as shown in FIGS. 1, 3A, and 3B. Id., 6:1-8. Ackermans
`
`22
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`

`

`explains that emitted light enters the skin and photodetectors detect light that
`
`reflects back from the skin. Id., 2:15-23, 6:1-8, 7:5-10, Abstract.
`
`40. Therefore, the combination of Ackermans and Savant renders obvious
`
`[1.1].
`
`EX1011, FIG. 1 (annotated).
`
`
`
`EX1011, FIGS. 3A, 3B (depicting the tissue measurement site and reflection
`therefrom)
`
`
`
`23
`
`

`

`[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, Ackermans describes that the optical sensor 10 is
`
`41.
`
`implemented within a “wristwatch” that is “attachable to the skin 50 of a patient
`
`with an elastic band 92, for example an arm wrist.” EX1011, 10:29-35.
`
`42. Also in the combination, Savant 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. 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.
`
`24
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`

`

`43. The following modified FIG. 1 from Ackermans shows the optical
`
`sensor 10 incorporating a light shaping diffuser, as described by Savant:
`
`
`EX1011, FIG. 1 (annotated and modified to add light-shaping diffuser from
`Savant, shown in green)
`44. As previously discussed, I believe that a POSITA would have been
`
`motivated to implement a light-shaping diffuser, such as those described in Savant,
`
`in the optical sensor 10 of Ackermans. See Section IV.A.
`
`45. Therefore, the combination of Ackermans and Savant renders obvious
`
`[1.2].
`
`
`
`
`
`25
`
`

`

`[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;
`46. As explained above with respect to [1.0] and shown below in FIG. 1,
`
`Ackermans discloses at least one photo-detector (30) for detecting light (31)
`
`reflected from the skin (50). EX1011, Abstract, 2:15-23, 4:22-25. “The [at least
`
`one] photo-detector 30 is circular in shape and mounted in the circular groove
`
`formed by the base plate 45, the outer ring 41 and the inner ring 42.” Id. In some
`
`implementations, a plurality of detectors can be implemented as “small
`