IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Ammar Al-Ali
`In re Patent of:
`10,687,745 Attorney Docket No.: 50095-0045IP1
`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
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`1
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`APPLE 1003
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`TABLE OF CONTENTS
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`B. 
`
`C. 
`
` 
`Background .................................................................................................... 9 
`I. 
`Level of Ordinary Skill in the Art ............................................................... 10 
`II. 
`Interpretations of the ’745 Patent Claims at Issue ....................................... 11 
`III. 
`IV.  Prior Art Analysis ........................................................................................ 12 
`A.  Ground 1A: Claims 1 and 9 are obvious over Iwamiya in
`view of Sarantos ................................................................................ 12 
`1. 
`Overview of Iwamiya ............................................................. 12 
`2. 
`Overview of Sarantos .............................................................. 13 
`3. 
`Analysis ................................................................................... 14 
`Ground 1B: Claims 15, 18, 20, and 27 are obvious over
`Iwamiya and Sarantos in view of Venkatraman ............................... 26 
`1. 
`Overview of Venkatraman ...................................................... 26 
`2. 
`Analysis ................................................................................... 27 
`Ground 2A: Claims 1, 9, 15, and 18 are obvious over
`Sarantos in view of Shie .................................................................... 35 
`1. 
`Overview of Shie .................................................................... 35 
`2. 
`Analysis ................................................................................... 36 
`D.  Ground 2B: Claims 15, 18, 20, 27 are obvious over Sarantos
`and Shie in view of Venkatraman ..................................................... 45 
`1. 
`Analysis ................................................................................... 45 
`Legal Principles ........................................................................................... 49 
`A.  Anticipation ....................................................................................... 49 
`B. 
`Obviousness ....................................................................................... 50 
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`V. 
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`2
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`I, Brian W. Anthony, of Cambridge, MA, declare that:
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`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
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`Scientist at MIT’s Mechanical Engineering department, Director of the Master of
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`Engineering in Advanced Manufacturing and Design Program at MIT, Director of
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`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
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`Medical Engineering & Science, and Associate Director of MIT.nano. My current
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`curriculum vitae is attached and some highlights follow.
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`2.
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`I earned my B.S. in Engineering (1994) from Carnegie Mellon
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`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.
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`3.
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`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.
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`6.
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`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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`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
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`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.
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`11.
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`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,” APPLE-1001)
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`and prior art references relating to its subject matter. I have reviewed the ’745
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`Patent and relevant excerpts of the prosecution history of the ’745 Patent
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`(EX1002). I have also reviewed the following prior art references and materials, in
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`addition to other materials I cite in my declaration:
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`APPLE-1004: U.S. Pat. No. 8,670,819 (“Iwamiya”)
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`APPLE-1005: U.S. Pat. No. 9,392,946 (“Sarantos”)
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`APPLE-1006: U.S. Pub. No. 2014/0275854 (“Venkataraman”)
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`APPLE-1007: U.S. Pat. No. 6,483,976 (“Shie”)
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`APPLE-1008: U.S. Pat. No. 6,801,799 (“Mendelson-799”)
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`APPLE-1009: U.S. Pub. No. 2015/0018647 (“Mandel”)
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`APPLE-1010: U.S. Pub. No. 2009/0275810 (“Ayers”)
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`APPLE-1011: PCT. Pub. No. 2011/051888 (“Ackermans”)
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`APPLE-1012: U.S. Pat. No. 6,158,245 (“Savant”)
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`APPLE-1013: Design of Pulse Oximeters, J.G. Webster;
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`Institution of Physics Publishing, 1997 (“Webster”)
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`APPLE-1014: U.S. Pub. No. 2009/0054112 (“Cybart”)
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`APPLE-1015: U.S. Pat. No. 5,893,364 (“Haar”)
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`APPLE-1016: U.S. Pat. No. 5,952,084 (“Anderson”)
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`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.
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`14.
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`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
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`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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`8
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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[.]”
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`APPLE-1001, Face, Abstract.
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`17.
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`Independent claim 1 of the ’745 patent is generally representative:
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`18.
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`19.
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`1. A physiological monitoring device comprising:
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`a plurality of light-emitting diodes configured to emit
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`light in a first shape;
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`20.
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`a material configured to be positioned between the
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`plurality of light-emitting diodes and tissue on a wrist of a user when
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`the physiological monitoring device is in use, the material configured
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`to change the first shape into a second shape by which the light
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`emitted from one or more of the plurality of light-emitting diodes is
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`projected towards the tissue;
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`21.
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`a plurality of photodiodes configured to detect at least a
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`portion of the light after the at least the portion of the light passes
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`through the tissue, the plurality of photodiodes further configured to
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`output at least one signal responsive to the detected light;
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`22.
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`a surface comprising a dark-colored coating, the surface
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`configured to be positioned between the plurality of photodiodes and
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`9
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`the tissue when the physiological monitoring device is in use, wherein
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`an opening defined in the dark-colored coating is configured to allow
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`at least a portion of light reflected from the tissue to pass through the
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`surface;
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`23.
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`a light block configured to prevent at least a portion of the
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`light emitted from the plurality of light-emitting diodes from reaching
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`the plurality of photodiodes without first reaching the tissue; and
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`24.
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`a processor configured to receive and process the
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`outputted at least one signal and determine a physiological parameter
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`of the user responsive to the outputted at least one signal.
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`II. Level of Ordinary Skill in the Art
`25. 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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`26. 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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`27.
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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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`III.
`28.
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`Interpretations of the ’745 Patent Claims at Issue
`I understand that, for purposes of my analysis in this inter partes
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`review proceeding, the terms appearing in the patent claims should generally be
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`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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`11
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`IV. Prior Art Analysis
`A. Ground 1A: Claims 1 and 9 are obvious over Iwamiya in
`view of Sarantos
`1. Overview of Iwamiya
`Iwamiya discloses an “optical biological information detecting
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`29.
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`apparatus” which is a physiological monitoring device. APPLE-1004, Abstract.
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`For example, Iwamiya describes that the “optical biological information detecting
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`apparatus” is provided in “a central portion of the back cover” of “a wristwatch”
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`(i.e., facing the wearer’s wrist). APPLE-1004, 5:54-66, FIG. 1. As shown in the
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`following annotated FIG. 4 from Iwamiya, the device includes LEDs 6 (shown in
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`green) that emit light (orange) that is refected by the tissue of the wearer’s wrist
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`(pink) and detected by photodiodes 9 (yellow).
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`12
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`2. Overview of Sarantos
`30. 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.” APPLE-1005, 2:5-14, 5:55-59, 7:12-14,
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`13:39-47. The monitor performs these measurements using a
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`photoplethysmographic (PPG) sensor, which includes one or more light sources
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`(e.g., LEDs) and an array of photodetectors. Id., 1:9-10, 43-47, 7:12-16, 15:23-43.
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`Sarantos describes that when the monitor “is worn by a person in a manner similar
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`to a wristwatch, the back face” of the monitor “may be pressed against the person's
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`skin, allowing the light sources” of the PPG sensor “to illuminate the person’s
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`skin.” Id., 1:48-51, 7:12-23. The light “diffuses through the person's flesh and a
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`portion of this light is then emitted back” (i.e., reflected) “out of the person's skin
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`in close proximity to where the light was introduced into the flesh.” Id., 7:24-28.
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`The photodetector array of the PPG sensor measures the “intensity” of this
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`reflected light, and provides signals representing the intensity to “control logic” of
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`the monitoring device. APPLE-1005, 2:5-14, 7:12-23, 13:39-47. The control logic
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`can then calculate different physiological parameters based on characteristics of
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`the reflected light signal. Id., 1:54-56, 7:12-23. For example, the person’s heart
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`rate can be calculated based on “fluctuations in the amount of light from the light
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`13
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`source that is emanated back out of the flesh” that correspond fluctuations in blood
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`volume associated with each beat of the person’s heart. Id., 7:23-60.
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`3.
`
`Analysis
`Claim 1
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`(a)
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`[1.0] A physiological monitoring device comprising:
`31.
`In the combination, Iwamiya discloses an “optical biological
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`information detecting apparatus” which is a physiological monitoring device.
`
`APPLE-1004, 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). APPLE-1004, 5:54-
`
`66, FIG. 1. As shown in the following annotated FIG. 4 from Iwamiya, the device
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`includes LEDs 6 (shown in green) that emit light (orange) that is refected by the
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`tissue of the wearer’s wrist (pink) and detected by photodiodes 9 (yellow).
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`14
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`32.
`
` Accordingly, the combination of Iwamiya and Sarantos renders
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`obvious a “physiological monitoring device.”
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`[1.1] a plurality of light-emitting diodes configured to emit light in a first shape;
`33.
`In the combination, Iwamiya discloses “light emitting units 6” that are
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`each “composed of a light emitting diode (LED).” APPLE-1004, 6:7-11, 6:32-39.
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`The light emitting units 6 are shown in green in the following annotated FIG. 3
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`from Iwamiya:
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`15
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`APPLE-1004, Detail of FIG. 3 (annotated)
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`34. The light emitting units 6 “emit observation light of a specific
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`wavelength band to optically observe a skin tissue of a human body.” Id., 6:7-11.
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`The emitted observation light is in a first shape characterized by the specific
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`location of each light emitting unit, e.g., the “3 o'clock” and “9 o'clock” positions
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`as shown in FIGS. 3 and 4 of Iwamiya. See id., 6:7-11, FIGS. 3-4.
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`[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;
`35.
`In the combination, Iwamiya describes that the physiological sensor
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`includes “an annular light guide unit 7 that guides the observation light emitted
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`from the light emitting units 6 and annularly diffuses and irradiates the observation
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`light with respect to a skin H.” APPLE-1004, 6:7-14, Fig. 4. The annular light
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`guide unit 7 includes “a light guiding ring portion 11” formed “using a material
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`such as transparent glass or a transparent resin with a high light transmitting
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`property.” Id., 6:40-45. The annular light guide unit 7 also includes “a
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`diffusion/irradiation ring portion 12” that is “formed in almost a ring shape, using a
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`clouded or milky resin with a light diffusing property.” Id., 6:40-42, 7:4-6. The
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`following annotated FIGS. 2 and 4 from Iwamiya show top and cross-section
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`views of physical monitoring device the annular light guide unit 7 (annotated in
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`teal).
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`APPLE-1004, Detail of FIG. 2 (annotated)
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`17
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`36. Annular light guide unit 7 changes the shape of the light emitted from
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`individual light emitting units 6 to an annular shape (a second shape) and causes
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`the light to irradiate an annular portion of tissue. Id., 11:55-12:36. As shown in
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`the following annotated FIG. 4 from Iwamiya, the light from the light emitting
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`units (the orange arrows) irradiates “an irradiation area E” in the user tissue
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`“having a ring shape” (shown in yellow). Id., 7:61-65:
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`18
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`37. As previously discussed (see [1.0], supra), Iwamiya’s physiological
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`sensor in Figure 4 is a wristwatch. See, e.g., APPLE-1004, 6:22-31. Therefore,
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`annular light guide unit 7 is positioned between light emitting units 6 and tissue on
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`the wrist, as shown in annotated FIG. 4 below:
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`
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`[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;
`38.
`In the combination, Iwamiya describes that the physical monitoring
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`device includes a plurality of photodiodes. APPLE-1004, 14:36-41 (disclosing
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`“plural light receiving units 9”), 8:20-23 (stating that each unit is “composed of a
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`silicon photo diode”). The photodiodes are configured to detect light after the light
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`passes through tissue and output a signal responsive to the detected light, which is
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`used to determine a physiological parameter of a user. See APPLE-1004, 9:28-32
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`(“the observation light emitted from the light emitting unit 6 is irradiated onto the
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`skin H and the scattered light thereof is received by the light receiving unit 9”
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`which “outputs a current signal according to the amount of received light”), 8:61-
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`9:7 (describing “convert[ing] a current signal output from the light receiving unit
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`9” into a “voltage signal” and then displaying resulting biological information).
`
`39. The following annotated FIG. 4 from Iwamiya shows that the light
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`(shown as orange arrows) emitted by the light emission units 6 (in green) is
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`reflected by the tissue H (in pink) and received by the photodiodes 9 (in yellow).
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`
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`[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,
`40.
`In the combination, Iwamiya describes a “light shielding frame 18”
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`surrounding the photodiodes 9. APPLE-1004, 8:38-47, FIG. 4. As shown in FIG.
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`20
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`4 from Iwamiya, the light shielding frame 18 (shown in pink) is positioned
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`between the photodiodes 9 (in yellow) and the tissue (in pink):
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`APPLE-1004, Detail of FIG. 4 (annotated)
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`
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`41. Also in the combination, Sarantos discloses a wrist-worn reflectance-
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`based physiological sensor that has a dark-colored coating 2276 to block light.
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`APPLE-1005, 5:55-58, Fig. 22. Saranto's also discloses that light source 2208
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`emits light through a window into a user’s skin, wherein the light is reflected from
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`the skin and back to the sensor and detected by photodetector elements 2212.
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`APPLE-1005, 17:16-25. The light travels through openings 2226 in the dark-
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`colored coating 2276 applied to window 2278. Id.. Specifically, Sarantos discloses
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`that “in-mold label 2276 may be black or otherwise rendered opaque to light to
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`prevent light from entering or exiting the PPG sensor through the window 2278
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`except through window regions 2226.” APPLE-1005, 17:1-16. Sarantos explains
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`that various masking techniques may be used to block stray light from reaching the
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`photodetector elements 2212, including “a painted or silk-screened mask” applied
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`to the window 2278. Id.
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`42. A POSITA would have been motivated to employ an in-mold label or
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`other black or opaque material as disclosed by Sarantos in the light shielding frame
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`18 of Iwamiya to serve the purpose indicated by the component’s name: shielding
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`the photodiodes 9 from stray light (one of the dominant noise sources), and thereby
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`ensuring accuracy of the sensor. See, e.g., APPLE-1004, 8:38-47, FIG. 4; APPLE-
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`1005, 5:55-58, 17:1-25, FIG. 22. A POSITA would have understood that a dark-
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`colored coating, such as that described by Sarantos, would have served this
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`purpose by not only blocking light but also by limiting reflections, which could
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`lead to stray light being incident on the photodiodes 9. It also would have been
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`obvious to a POSITA to use a dark-colored coating for light shielding frame 18
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`because dark-colored coatings and materials were well-known to effectively block
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`light. See, e.g., APPLE-1005, 17:1-10. A POSITA would have known that a light
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`shielding frame 18 or holder portion 43 as disclosed by Iwamiya can be of various
`
`proportions, and a thin surface is a coating. See id. Because using dark-colored
`
`coatings in light blocks was so well-known, and Iwamiya and Sarantos are both
`
`wrist-worn reflectance-based physiological sensors, a POSITA would have
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`22
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`reasonably understood the combination of Iwamiya with Sarantos to be successful
`
`with no unexpected results. Id.
`
`[1.5] 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;
`43. As previously discussed (see [1.4]), in the combination, the “light
`
`shielding frame 18” of Iwamiya employs a dark-colored coating, such as that
`
`described by Sarantos. Iwamiya further describes an “an optical filter 17” that “is
`
`mounted on the lower side of a light shielding frame 18” between the photodiodes
`
`9 and the tissue H. APPLE-1004, 8:39-42. This configuration is shown in the
`
`following detail of FIG. 4 from Iwamiya:
`
`APPLE-1004, Detail of FIG. 4 (annotated)
`
`
`
`23
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`44.
`
`Iwamiya describes that the “optical filter 17 is configured to transmit
`
`light of a specific wavelength band of 900 nm or more,” and thus is configured to
`
`allow at least a portion of light reflected from the tissue to pass through to the
`
`photodiodes 9. APPLE-1004, 8:42-44.
`
`[1.6] 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
`In the combination, FIG. 3 of Iwamiya shows reflection layers 13 and 15
`
`(annotated in dark blue) that prevent light within annular light guide 7 from leaking
`
`outside of the annular light guide. APPLE-1004, 6:62-7:3, 7:41-49, FIG. 3:
`
`APPLE-1004, Detail of FIG. 3 (annotated)
`
`45. By preventing the light from leaking outside of the light guide 7, the
`
`reflection layers 13 and 15 act as light blocks that prevent light emitted from light
`
`
`
`24
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`emitting unit 6 from directly reaching the photodiodes 9 without first reaching the
`
`tissue. APPLE-1004, 6:62-7:3, 7:41-49, FIG. 3.
`
` [1.7] 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.
`46.
`In the combination, Iwamiya discloses a central processing unit (CPU)
`
`20 that controls the disclosed biological information detecting apparatus. APPLE-
`
`1004, 8:61- 9:7. The CPU receives a current signal from the photodiodes of
`
`Iwamiya, processes it into a voltage signal, and then determines and displays a
`
`physiological parameter of the user, such as a heart rate, based on the signal.
`
`APPLE-1004, 8:61-9:7, 9:36-43.
`
`(b)
`
`Claim 9
`
`[9.0] The physiological monitoring device of claim 1, wherein the physiological
`parameter comprises oxygen saturation.
`47.
`In the combination, Iwamiya discloses a sensor that detects
`
`“biological information,” which includes oxygen saturation, and provides the
`
`example of a “pulse wave” or heart rate, wherein oxygen saturation comprises
`
`heart rate sensing at different wavelengths. APPLE-1004, 8:61-9:7.
`
`48. Also in the combination, Sarantos discloses measuring blood
`
`oxygenation levels. APPLE-1005, 13:40-14:22. To the extent not disclosed by
`
`Iwamiya, a POSITA would have been motivated to determine oxygen saturation
`
`using Iwamiya’s physiological sensor, based on the teachings of Sarantos, in order
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`25
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`to expand the range of physiological parameters measured by Iwamiya’s sensor,
`
`thereby improving the functionality and utility of the sensor. See, e.g., APPLE-
`
`1005, 13:40-14:22. A POSITA would have reasonably expected success in
`
`adapting Iwamiya’s sensor to this purpose because wrist-worn pulse oximetry
`
`sensors, such as that described in Sarantos, were well-known in the art. See, e.g.,
`
`APPLE-1005, 13:40-14:22, FIG. 2.
`
`B. Ground 1B: Claims 15, 18, 20, and 27 are obvious over
`Iwamiya and Sarantos in view of Venkatraman
`1. Overview of Venkatraman
`49. Venkatraman teaches a portable biometric monitoring device with a
`
`touchscreen display that can be worn on the wrist like a watch. APPLE-1006,
`
`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.” APPLE-1006, 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.” APPLE-1006, 14:28-36.
`
`Venkatraman device also includes a digital display with “uses capacitive touch
`
`detection” to display data acquired or stored locally on the wristwatch. APPLE-
`
`1006, 53:19-55:51.
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`26
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`

`

`50. Venkatraman further discloses transmitting information wirelessly
`
`from its monitoring device to a secondary device such as a smartphone. APPLE-
`
`1006, 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. APPLE-1006, 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. APPLE-1006,
`
`37:41-63, 55:29-51, 57:20-58:9.
`
`2.
`
`Analysis
`Claim 15
`
`(a)
`
`[15.0] A physiological monitoring device comprising:
`51.
`See [1.0].
`
`[15.1] a plurality of light-emitting diodes configured to emit light proximate a
`wrist of a user;
`52. As previously discussed (see [1.0]-[1.1]), in the combination,
`
`Iwamiya’s physiological sensor shown in Figure 4 is a wristwatch. APPLE-1004,
`
`5:54-67, 6:22-31. Therefore, light emitting units 6 emit light proximate a user’s
`
`wrist. Id..
`
`[15.2] a light diffusing material configured to be positioned between the plurality
`of light-emitting diodes and a tissue measurement site on the wrist of the user
`when the physiological monitoring device is in use;
`53.
`See [1.2].
`
`27
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`

`[15.3] a light block having a circular shape;
`54. As discussed above regarding claim element [1.6] with reference to
`
`Figures 3 and 4 of Iwamiya, reflection layers 13 and 15 are a light block. APPLE-
`
`1004, 6:62-7:3; see [1.6], supra. Figure 2 of Iwamiya shows reflection layers 13
`
`and 15 each having a circular shape as they are formed on outer surfaces of light
`
`guiding ring portion 11 and diffusion/irradiation ring portion 12, respectively,
`
`which together form annular light guide unit 7. APPLE-1004, 6:62-7:3, 7:41-49,
`
`FIGS. 2-4:
`
`APPLE-1004, Detail of FIG. 2 (annotated)
`
`
`
`28
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`[15.4] a plurality of photodiodes configured to detect at least a portion of the
`light emitted from the plurality of light-emitting diodes after the light passes
`through the light diffusing material