IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Ammar Al-Ali
`In re Patent of:
`10,687,745 Attorney Docket No.: 50095-0045IP2
`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
`
`
`
`
`
`
`
`1
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`APPLE 1003
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`

`

`
`Background ................................................................................................. 10
`I.
`Level of Ordinary Skill in the Art ............................................................... 11
`II.
`Interpretations of the ’745 Patent Claims at Issue ...................................... 12
`III.
`IV. Prior Art Analysis ....................................................................................... 12
`A. Ground 1A: Claims 1, 9, 15, and 18 are obvious over
`Ackermans in view of Savant ........................................................... 12
`1.
`Overview of Ackermans ......................................................... 12
`2.
`Overview of Savant ................................................................ 14
`3.
`The combination of Ackermans and Savant ........................... 15
`4.
`Reasons to combine Ackermans and Savant .......................... 16
`5.
`Analysis .................................................................................. 18
`Ground 1B: Claims 20 and 27 are obvious over Ackermans
`and Savant in view of Venkatraman ................................................. 37
`1.
`Overview of Venkatraman ..................................................... 37
`2.
`The combination of Ackermans, Savant, and
`Venkatraman........................................................................... 38
`Reasons to combine Ackermans, Savant, and
`Venkatraman........................................................................... 38
`Analysis .................................................................................. 40
`4.
`Ground 2A: Claims 1, 9, 15, 18, 20, and 27 are obvious over
`Mendelson-799 in view of Haar, Venkatraman, and Savant ............ 43
`1.
`Overview of Mendelson-799 .................................................. 43
`2.
`Overview of Haar ................................................................... 46
`3.
`The combination of Mendelson-799, Haar,
`Venkatraman, and Savant ....................................................... 48
`Reasons to combine Mendelson-799, Haar,
`Venkatraman, and Savant ....................................................... 48
`Analysis .................................................................................. 57
`5.
`Legal Principles ........................................................................................... 81
`
`V.
`
`B.
`
`C.
`
`TABLE OF CONTENTS
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`3.
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`4.
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`2
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`

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`A. Anticipation ...................................................................................... 81
`B.
`Obviousness ...................................................................................... 81
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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
`
`Research Scientist at the Institute of Medical Engineering & Science at
`
`Massachusetts Institute of Technology (MIT). I am also a Principal Research
`
`Scientist at MIT’s Mechanical Engineering department, Director of the Master of
`
`Engineering in Advanced Manufacturing and Design Program at MIT, Director of
`
`Health Technology at the MIT Center for Clinical and Translational Research, a
`
`Co-Director of the Medical Electronic Device Realization Center of the Institute of
`
`Medical Engineering & Science, and Associate Director of MIT.nano. My current
`
`curriculum vitae is attached and some highlights follow.
`
`2.
`
`I earned my B.S. in Engineering (1994) from Carnegie Mellon
`
`University. I earned my M.S. (1998) and Ph.D. (2006) in Engineering from MIT.
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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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`4
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`

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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
`
`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
`
`Engineering & Science at MIT. The Device Realization Lab designs instruments
`
`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
`
`intractable.
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`6
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`

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`7.
`
`The research of the Device Realization Lab focuses on product
`
`development interests cross the boundaries of computer vision, acoustic and
`
`ultrasonic imaging, large-scale computation and simulation, optimization,
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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
`
`experimental observations, to develop instruments and measurement solutions.
`
`8. My record of professional service includes recognitions from several
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`professional organizations in my field of expertise.
`
`9.
`
`I am a named inventor on 10 issued U.S. patents. Most but not all of
`
`these patents involve physiological monitoring and other measurement
`
`technologies.
`
`10.
`
`I have published approximately 100 papers, and have received a
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`number of best paper and distinguished paper awards. A number of papers that I
`
`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
`
`opinions relating to U.S. Patent No. 10,687,745 (“the ’745 patent,” APPLE-1001)
`
`and prior art references relating to its subject matter. I have reviewed the ’745
`
`Patent and relevant excerpts of the prosecution history of the ’745 Patent
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`7
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`(EX1002). I have also reviewed the following prior art references and materials, in
`
`addition to other materials I cite in my declaration:
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`APPLE-1004: U.S. Pat. No. 8,670,819 (“Iwamiya”)
`
`APPLE-1005: U.S. Pat. No. 9,392,946 (“Sarantos”)
`
`APPLE-1006: U.S. Pub. No. 2014/0275854 (“Venkataraman”)
`
`APPLE-1007: U.S. Pat. No. 6,483,976 (“Shie”)
`
`APPLE-1008: U.S. Pat. No. 6,801,799 (“Mendelson-799”)
`
`APPLE-1009: U.S. Pub. No. 2015/0018647 (“Mandel”)
`
`APPLE-1010: U.S. Pub. No. 2009/0275810 (“Ayers”)
`
`APPLE-1011: PCT. Pub. No. 2011/051888 (“Ackermans”)
`
`APPLE-1012: U.S. Pat. No. 6,158,245 (“Savant”)
`
`APPLE-1013: Design of Pulse Oximeters, J.G. Webster;
`
`Institution of Physics Publishing, 1997 (“Webster”)
`
`APPLE-1014: U.S. Pub. No. 2009/0054112 (“Cybart”)
`
`APPLE-1015: U.S. Pat. No. 5,893,364 (“Haar”)
`
`APPLE-1016: U.S. Pat. No. 5,952,084 (“Anderson”)
`
`12. Counsel has informed me that I should consider these materials
`
`through the lens of one of ordinary skill in the art related to the ’745 patent at the
`
`time of the earliest possible priority date of the ’745 patent, and I have done so
`
`during my review of these materials. The ’745 patent claims priority to an
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`8
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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
`
`claims of ’745 patent are possibly entitled, and I have therefore used that Critical
`
`Date in my analysis below.
`
`13.
`
`I have no financial interest in the party or in the outcome of this
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`proceeding. I am being compensated for my work as an expert on an hourly basis.
`
`My compensation is not dependent on the outcome of these proceedings or the
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`content of my opinions.
`
`14.
`
`In writing this Declaration, I have considered the following: my own
`
`knowledge and experience, including my work experience in the fields of
`
`mechanical engineering, computer science, biomedical engineering, and electrical
`
`engineering; my experience in teaching those subjects; and my experience in
`
`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.
`
`15. My opinions, as explained below, are based on my education,
`
`experience, and expertise in the fields relating to the ’745 patent. Unless otherwise
`
`stated, my testimony below refers to the knowledge of one of ordinary skill in the
`
`fields as of the Critical Date, or before. Any figures that appear within this
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`document have been prepared with the assistance of Counsel and reflect my
`
`understanding of the ’745 patent and the prior art discussed below.
`
`9
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`

`

`I.
`Background
`16. The ’745 patent, entitled “Advanced Pulse Oximetry Sensor,”
`
`describes a “non-invasive, optical-based physiological monitoring system[.]”
`
`APPLE-1001, 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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`10
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`

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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
`
`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
`
`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
`
`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
`
`not limited to physiological monitoring technologies. Alternatively, the person
`
`could have also had a Master of Science degree in a relevant academic discipline
`
`with less than a year of related work experience in the same discipline.
`
`19. Based on my experiences, I have a good understanding of the
`
`capabilities of a POSITA. Indeed, I have taught, participated in organizations, and
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`worked closely with many such persons over the course of my career.
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`20.
`
`I have performed my analysis through the lens of a POSITA as of the
`
`Critical Date.
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`11
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`III.
`21.
`
`Interpretations of the ’745 Patent Claims at Issue
`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.
`
`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
`
`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
`
`art is deemed to read the claim term not only in the context of the particular claim
`
`in which the disputed term appears, but in the context of the entire patent,
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`including the specification. Id.
`
`IV. Prior Art Analysis
`A. Ground 1A: Claims 1, 9, 15, and 18 are obvious over
`Ackermans in view of Savant
`1. Overview of Ackermans
`22. Ackermans describes an optical sensor 10 for measuring the blood
`
`oxygenation levels of a user. APPLE-1011, Abstract, 1, 2-5. As shown in FIGS. 1
`
`and 2 below, the optical sensor 10 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). A housing
`
`(40) for carrying the at least one light emitter (20) and the at least one photo-
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`12
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`

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`detector (30) is provided, where the housing (40) has a contact area with the skin
`
`(50).” APPLE-1011, Abstract, 4:22-25.
`
`
`
`
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`APPLE-1011, FIG. 1 (annotated)
`
`APPLE-1011, FIG. 2 (annotated)
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`13
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`23.
`
`In the example shown in FIG. 7, Ackermans’ optical sensor 10 is
`
`implemented within a wristwatch for placement on a user at a tissue measurement
`
`site. APPLE-1011, 10:29-35.
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`APPLE-1011, 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
`
`with an elastic band. APPLE-1011, 10:29-35. The “optical sensor 10 is positioned
`
`at 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. APPLE-1011, 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.
`
`2. Overview of Savant
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`14
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`

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`25. Savant, titled “High Efficiency Monolithic Glass Light Shaping
`
`Diffuser and Method of Making,” describes a “light shaping diffuser (LSD)” which
`
`“is a type of diffuser used in a variety of illuminating, imaging, and light projecting
`
`applications.” APPLE-1012, 1:16-19. “A LSD is a transparent or translucent
`
`structure having an entrance surface, an exit surface, and light shaping structures
`
`formed on its entrance surface and/or in its interior.” Id., 1:19-22. The “light
`
`shaping structures diffract light passing through the LSD so that the beam of light
`
`emitted from the LSD's exit surface exhibits a precisely controlled energy
`
`distribution along horizontal and vertical axes.” Id., 1:30-33. Savant describes
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`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.,
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`6:16-17.
`
`3.
`
`The combination of Ackermans and Savant
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`15
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`26.
`
`In the combination, the optical sensor 10 of Ackermans is modified to
`
`incorporate a light-shaping diffuser, such as those taught by Savant, between its
`
`emitters and the tissue measurement site. APPLE-1011, Abstract, 4:22-25, FIG. 1;
`
`APPLE-1012, 1:16-51, 6:16-17.
`
`4.
`Reasons to combine Ackermans and Savant
`27. A POSITA would have been motivated and found it obvious to
`
`modify Ackermans to incorporate a light-shaping diffuser, such as those taught by
`
`Savant, between its emitters and the tissue measurement site in order to more
`
`precisely control the distribution of light from the emitters across the tissue
`
`measurement site and improve sensor performance. As described by Savant, a
`
`light-shaping diffuser provides precise control over the shape of the exiting light.
`
`APPLE-1012, 1:37-40 (a light-shaping diffuser “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”). Such
`
`precise control would allow Ackermans’ device to be calibrated to increase the
`
`amount of reflected light received by the photodiodes by precisely controlling the
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`area of the tissue site being illuminated, thereby leading to more received light and
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`a higher signal-to-noise (SNR) ratio. APPLE-1011, Abstract, 4:22-25, FIG. 1;
`
`APPLE-1012, 1:16-51, 6:16-17. Use of a light-shaping diffuser would also enable
`
`different spatial configurations of photodiodes to be utilized in the optical sensor
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`16
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`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 id.
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`28. Further, a POSITA would have found it obvious to 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 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.”
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). A POSITA would have
`
`recognized that applying Savant’s teachings to augment Ackermans would have
`
`led to predictable performance enhancement without significantly altering or
`
`hindering the functions performed by Ackermans’ system.
`
`29.
`
`In fact, a POSITA would have been motivated to incorporate the well-
`
`known techniques of Savant into Ackermans to achieve the predictable benefits
`
`described in Savant. See, e.g., APPLE-1012, 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, including LEDs.” See APPLE-
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`1012, 1:49-51.
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`17
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`30. Accordingly, for at least these reasons, augmenting Ackermans’
`
`device based on the teachings of Savant would have been routine and
`
`straightforward to a POSITA, and it would have been clear that such a combination
`
`would predictably work and provide the expected results. Id.
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`5.
`
`Analysis
`Claim 1
`[1.0] A physiological monitoring device comprising:
`31. Ackermans describes an optical sensor 10 for measuring the blood
`
`(a)
`
`oxygenation levels of a user. APPLE-1011, Abstract, 1, 2-5. As shown in FIGS. 1
`
`and 2 below, the optical sensor 10 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). 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).” APPLE-1011, Abstract, 4:22-25.
`
`18
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`APPLE-1011, FIG. 1 (annotated)
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`
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`
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`APPLE-1011, FIG. 2 (annotated)
`
`32.
`
`In the example shown in FIG. 7, Ackermans’ optical sensor 10 is
`
`implemented within a wristwatch for placement on a user at a tissue measurement
`
`site. APPLE-1011, 10:29-35.
`
`19
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`

`
`
`
`
`APPLE-1011, FIG. 7 (annotated)
`
`
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`33. The frame 90 of the wristwatch is attachable to the skin 50 of a patient
`
`with an elastic band. APPLE-1011, 10:29-35. The “optical sensor 10 is positioned
`
`at 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. APPLE-1011, 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.
`
`34. Accordingly, Ackermans renders obvious “a wrist-worn physiological
`
`monitoring device configured for placement on a user at a tissue measurement
`
`site.”
`
`20
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` [1.1] a plurality of light-emitting diodes configured to emit light in a first shape;
`35. 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).” APPLE-1011, Abstract, 4:22-
`
`25.
`
`36.
`
`In more detail, Ackermans’ optical sensor 10 includes a light emission
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`source (emitter 20 with housing 46) comprising a plurality of emitters in the form
`
`of LEDs that emit light at different wavelengths. APPLE-1011, 6:1-8. These
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`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 explains that emitted light enters the skin and photodetectors detect
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`light that reflects back from the skin. Id., 2:15-23, 6:1-8, 7:5-10, Abstract.
`
`37.
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`
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`21
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`

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`APPLE-1011, FIG. 1 (annotated).
`
`
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`APPLE-1011, FIGS. 3A, 3B (depicting the tissue measurement site and reflection
`therefrom).
`
`
`
`22
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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;
`38.
`In the combination, Ackermans describes that the optical sensor 10 is
`
`implemented within a “wristwatch” that is “attachable to the skin 50 of a patient
`
`with an elastic band 92, for example an arm wrist.” APPLE-1011, 10:29-35.
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`39. 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
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`light projecting applications.” APPLE-1012, 1:16-19. Savant describes that
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`“LSDs can be used to shape a light beam so that over 90% (and up to 95%-98%) of
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`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
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`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
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`versatility because they may be employed with light from almost any source,
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`including LEDs, daylight, a tungsten halogen lamp, or an arc lamp.” Id., 1:49-51.
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`LSD’s can also be used to “control the angular spread of transmitted light.” Id.,
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`6:16-17.
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`23
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`40. The following modified FIG. 1 from Ackermans shows the optical
`
`sensor 10 incorporating a light shaping diffuser, as described by Savant:
`
`
`APPLE-1011, FIG. 1 (annotated and modified to add light-shaping diffuser from
`Savant, shown in green)
`41. As previously discussed, a POSITA would have been motivated to
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`implement a light-shaping diffuser, such as those described in Savant, in the
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`optical sensor 10 of Ackermans. See Section IV.A.3-4.
`
` [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;
`42. 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)
`
`24
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`

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`reflected from the skin (50). APPLE-1011, 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
`
`photodiodes that are arranged between the inner ring 43 and the outer ring 41.”
`
`Id., 6:9-15. As noted in [1.1], light emitted by the plurality of emitters enters the
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`skin, is attenuated, reflects from the skin, and is subsequently detected by the
`
`photodetectors, as shown in the following annotated figures from Ackermans. Id.,
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`2:15-23, 6:1-8, 7:5-10, Abstract; FIGS. 3A, 3B:
`
`43.
`
`
`
`APPLE-1011, FIG. 1 (annotated)
`
`
`
`
`
`25
`
`

`

`
`APPLE-1011, FIGS. 3A, 3B (annotated, depicting the tissue measurement site and
`reflection therefrom).
`44. Ackermans further describes that each photodiode produces
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`“[e]lectrical signals” representing detected light, which are then “processed in
`
`order to determine an oximetry value.” Id., 3:11-12.
`
`[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,
`45. As previously discussed (see [1.0]), in the combination, Ackermans’
`
`optical sensor 10 is implemented within a wristwatch for placement on a user at a
`
`tissue measurement site, as shown in FIG. 7. APPLE-1011, 10:29-35.
`
`
`
`
`
`26
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`

`

`APPLE-1011, FIG. 7 (annotated)
`
`
`
`46. The frame 90 of the wristwatch is attachable to the skin 50 of a patient
`
`with an elastic band. APPLE-1011, 10:29-35. The “optical sensor 10 is positioned
`
`at the center of the frame” 90. Id. Ackermans further describes that “in addition to
`
`the elastic band 92, the frame 90 could be attached to the skin 50 by a medical
`
`grade adhesive” (i.e., a coating). Id., 11:10-11. Ackermans describes that “the
`
`adhesive could be transparent and fix the sensor 10 as well as the frame 90.” Id.,
`
`11:11-12. Ackermans also describes that “the adhesive could be provided with a
`
`central opening that leaves the vicinity of the sensor 10 on the skin blank and only
`
`fixes the frame 90.” Id., 11:12-15. In such a case, Ackermans teaches that “the
`
`adhesive does not have to be transparent,” and thus is opaque or dark-colored. 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;
`47. As discussed above (see [1.4]), Ackermans describes that the sensor
`
`10 is attached to the user’s skin using a non-transparent adhesive (i.e., a dark-
`
`colored coating). Ackermans also describes that “the adhesive could be provided
`
`with a central opening that leaves the vicinity of the sensor 10 on the skin blank
`
`and only fixes the frame 90,” thereby allowing light reflected from the tissue to
`
`pass through. APPLE-1011, 11:12-15.
`
`27
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`

`

` [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
`48. As explained above with respect to [1.0], [1.3], Ackermans’ inner ring
`
`43 “shadows the photodetector 30 from emitted light 21” and operates as a light
`
`block that prevents light from the emitters 20 from being detected directly by the
`
`photodetectors 30 without attenuation by the user’s skin. APPLE-1011, 5:10-15.
`
`49.
`
`In more detail, Ackermans’ inner ring 43 includes rim 44. Id., 4:25.
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`As shown in FIGS. 1 and 2 below, A POSITA would have understood that the
`
`inner ring 43 and its rim 44 form a wall between the emitter 20 (light emission
`
`source) and the plurality of detectors 30. Id., 4:22-32, 6:22-31. “Both the light
`
`emitter 20 and the photo-detector 30 are mounted recessed from the plane defined
`
`by the rims 42 and 44. As a result, the inner ring 43 prevents light emitted by the
`
`light emitter 20 from shining directly into the photo–detector 30.” Id., 6:31-35.
`
`APPLE-1011, FIGS. 1 (left) and 2 (right), (annotated)
`
`
`
`28
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`

`

`[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.
`50. As previously discussed, Ackermans describes that the plurality of
`
`photodiodes produce “[e]lectrical signals” representing detected light, which are
`
`then “processed in order to determine an oximetry value” (i.e., a physiological
`
`parameter). APPLE-1011, 3:11-12. Ackermans further describes an “electrical
`
`element” (i.e., a processor) for “receiving and processing the electrical signals of
`
`the photo-detectors.” APPLE-1011, 10:6-8.
`
`(b) Claim 9
`[9.0] The physiological monitoring device of claim 1, wherein the physiological
`parameter comprises oxygen saturation.
`51.
`In the combination, Ackermans describes that the sensor 10
`
`determines physiological parameters including “oxygen saturation.” APPLE-1011,
`
`6:15-18 (“[a] typical application of the shown optical medical s