IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Poeze et al.
`In re Patent of:
`10,912,501
`U.S. Patent No.:
`February 9, 2021
`Issue Date:
`Appl. Serial No.: 17/031,356
`Filing Date:
`September 24, 2020
`Title:
`USER-WORN DEVICE FOR NONINVASIVELY MEASURING
`A PHYSIOLOGICAL PARAMETER OF A USER
`
`Attorney Docket No. 50095-0042IP2
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`DECLARATION OF DR. THOMAS W. KENNY
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`I currently hold the opinions set expressed in this declaration. But my
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`analysis may continue, and I may acquire additional information and/or attain
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`supplemental insights that may result in added observations.
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`I hereby declare that all statements made of my own knowledge are true and
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`that all statements made on information and belief are believed to be true. I further
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`declare that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both,
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`under Section 1001 of the Title 18 of the United States Code.
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`Dated: July 14, 2022
`
`By:
`
`Thomas W. Kenny, Ph.D.
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`1
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`APPLE 1003
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`
`
`TABLE OF CONTENTS
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`B.
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`QUALIFICATIONS AND BACKGROUND INFORMATION ................... 3
`I.
`OVERVIEW OF CONCLUSIONS FORMED ............................................ 10
`II.
`III. LEVEL OF ORDINARY SKILL IN THE ART .......................................... 11
`IV. THE ’501 PATENT ..................................................................................... 12
`A. Overview ............................................................................................ 12
`PRIOR ART ANALYSIS ............................................................................ 14
`A.
`[GROUND 1A] – CLAIMS 1, 2, 5, 7-8, 11-19, 22, AND 25 ARE
`OBVIOUS OVER LUMIDIGM, SCHARF, AND KOTANAGI ...... 14
`1.
`Lumidigm describes a wristwatch having an optical sensor ... 14
`2.
`Scharf describes pulse oximeters having glass covers ............ 20
`3.
`Kotanagi describes an optical sensor that protrudes from a
`bottom surface of a wristwatch ................................................ 21
`The combination of Lumidigm, Scharf, and Kotanagi ............ 24
`4.
`Reasons to combine Lumidigm, Scharf, and Kotanagi ........... 30
`5.
`Analysis ................................................................................... 41
`6.
`[GROUND 1B] – CLAIMS 3-4, 6, 9-10, 20-21, 23-24, AND 26-30
`ARE OBVIOUS OVER LUMIDIGM, SCHARF, KOTANAGI, AND
`TRAN ................................................................................................. 89
`1.
`Tran describes a portable multi-function electronic device with
`a network interface that measures oxygen, oxygen saturation,
`and temperature, and includes a touch screen display ............. 89
`The combination of Lumidigm, Scharf, Kotanagi, and Tran .. 94
`2.
`Reasons to combine Lumidigm, Scharf, Kotanagi, and Tran .. 96
`3.
`Analysis ................................................................................. 101
`4.
`VI. LEGAL STANDARDS .............................................................................. 115
`A.
`Terminology ..................................................................................... 115
`B.
`Legal Standards for Anticipation ..................................................... 116
`C.
`Legal Standards for Obviousness ..................................................... 117
`VII. CONCLUSION .......................................................................................... 122
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`
`V.
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`2
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`
`
`I.
`QUALIFICATIONS AND BACKGROUND INFORMATION
`1. My education and experience are described more fully in the attached
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`curriculum vitae (APPLE-1004). For ease of reference, I have highlighted certain
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`information below.
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`2. My academic and professional background is in Physics, Mechanical
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`Engineering, Sensing, and Robotics, with a research specialization focused on
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`microfabricated physical sensors, and I have been working in those fields since the
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`completion of my Ph.D. more than 30 years ago. The details of my background
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`and education and a listing of all publications I have authored in the past 35 years
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`are provided in my curriculum vitae, APPLE-1004. Below I provide a short
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`summary of my education and experience which I believe to be most pertinent to
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`the opinions that I express here.
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`3.
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`I received a B.S. in Physics from University of Minnesota,
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`Minneapolis in 1983, and a Ph.D. in Physics from University of California at
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`Berkeley in 1989. I was educated as a Physicist specializing in sensors and
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`measurement. My Physics Ph.D. thesis involved measurements of the heat
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`capacity of monolayers of atoms on surfaces, and relied on precision
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`measurements of temperature and power using time-varying electrical signals, and
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`also on the design and construction of miniature sensor components and associated
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`electrical circuits for conditioning and conversion to digital format.
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`4.
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`After completion of my Ph.D. in Physics at U.C. Berkeley in 1989, I
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`joined the Jet Propulsion Laboratory (JPL) in Pasadena, CA, as a staff scientist,
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`and began working on miniature sensors and instruments for small spacecraft.
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`This work involved the use of silicon microfabrication technologies for
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`miniaturization of the sensors, and served as my introduction to the field of micro-
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`electromechanical systems (MEMS), or the study of very small mechanical sensors
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`powered by electricity and used for detection of physical and chemical signals.
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`5. While at JPL, we developed accelerometers, uncooled infrared
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`sensors, magnetometers, seismometers, force and displacement sensors, soil
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`chemistry sensors, miniature structures for trapping interstellar dust, and many
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`other miniature devices. Some of these projects led to devices that were launched
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`with spacecraft headed for Mars and for other interplanetary missions. Much of
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`this work involved the use of physical sensors for detection of small forces and
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`displacements using micromechanical sensors.
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`6.
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`I am presently the Richard Weiland Professor at the Department of
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`Mechanical Engineering at Stanford University, where I have taught for the past 26
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`years. I am also currently the Senior Associate Dean of Engineering for Student
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`Affairs at Stanford.
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`7.
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`For 27 years, I have taught courses on Sensors and Mechatronics at
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`Stanford University. The “Introduction to Sensors” course is a broad overview of
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`all sensing technologies, from thermometers, to inertial sensors, ultrasound
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`devices, flow sensors, optical and IR sensors, chemical sensors, pressure sensors,
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`and many others, and has included sensors based on changes in capacitance,
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`resistance, piezoelectricity. This course specifically included different
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`mechanisms for sensing heart rate, blood pressure, blood chemistry, cardiovascular
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`blood flow and pressure drops, intraocular pressure and other physiological
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`measurements, as well as activity monitoring (step counting, stair-counting, etc). I
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`first taught this course at Stanford in the Spring of 1994, and I offered this course
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`at least annually until 2016, when my duties as Senior Associate Dean made this
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`impractical. I’ve just completed teaching the 2022 offering of this class.
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`8.
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`The “Introduction to Mechatronics” course is a review of the
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`mechanical, electrical and computing technologies necessary to build systems with
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`these contents, which include everything from cars and robots to cellphones and
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`other consumer electronics devices. In this class, we routinely use IR, LEDs, and
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`photosensors as a way of detecting proximity to objects in the space around
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`miniature robots. We also use inertial sensors to detect movement, and a number
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`of sensors, such as encoders to measure changes in position and trajectory. I was
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`one of the instructors for the first offering of this course in 1995, and this course
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`has been offered at least once each year ever since, with plans already underway
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`for the Winter 2021 offering. The 2022 offering was completed earlier this year,
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`and was highly-successful with 70 undergraduate and graduate students from many
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`engineering and science disciplines.
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`9.
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`I am co-author of a textbook titled “Introduction to Mechatronic
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`Design,” which broadly covers the topic of integration of mechanical, electronic
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`and computer systems design into “smart products.” This textbook includes
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`chapters on Microprocessors, Programming Languages, Software Design,
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`Electronics, Sensors, Signal Conditioning, and Motors, as well as topics such as
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`Project Management, Troubleshooting, and Synthesis.
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`10. My research group has focused on the area of microsensors and
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`microfabrication—a domain in which we design and build micromechanical
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`sensors using silicon microfabrication technologies. The various applications for
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`these technologies are numerous.
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`11.
`
`I have advised 73 Ph.D. students that have completed Ph.D. degrees
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`and many more M.S. and B.S. students in Engineering during my time at Stanford.
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`12.
`
`I have published over 250 technical papers in refereed journals and
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`conferences in the field of sensors, MEMS, and measurements. I have further
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`presented numerous conference abstracts, posters, and talks in my field. I am a
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`named inventor on 50 patents in my areas of work.
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`13.
`
`I received the Office of the Secretary of Defense Award for
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`Exceptional Public Service in 2010, the IEEE Sensors Council Technical
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`Achievement Award in 2011, and was named Fellow of the ASME in 2014. I was
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`awarded the 2018 IEEE Daniel Noble Award for Emerging Technologies. In
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`2022, I was elected to the National Academy of Engineering.
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`14.
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`I have previously served as an expert on a patent infringement case
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`involving the mounting and use of pressure sensors on guidewire catheters for
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`cardiovascular procedures that included a number of sensing aspects, such as
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`recording static and dynamic pressure signals, and compensating for electrical and
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`mechanical errors. I have also previously served as an expert on a patent
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`infringement case involving the design and use of miniature inertial sensors. That
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`case involved the design and operations of micromechanical sensors, and
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`particularly the use of inertial sensors for detection of states of movement and rest.
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`I have also served as an expert in a patent infringement case involving the use of
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`sensors on athletic shoes for determining athletic performance. More recently, I
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`served as an expert in a patent infringement case involving optical proximity
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`sensors in smartphones. My CV, APPLE-1004, includes a full listing of all cases
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`in which I have testified at deposition or trial in the preceding four years.
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`15.
`
`I have been retained on behalf of Apple Inc. to offer technical
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`opinions relating to U.S. Patent No. 10,912,501 (“the ’501 Patent”) and prior art
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`references relating to its subject matter. I have reviewed the ’501 Patent, and
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`relevant excerpts of the prosecution history of the ’501 Patent. In addition to any
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`
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`materials cited in the present declaration, I have also reviewed the following
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`references:
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`16. APPLE-1005: Masimo Corporation, et al. v. Apple Inc., Redacted
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`Complaint, ITC Inv. No.37-TA-1276
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`17. APPLE-1006: US Pat. No. 7,620,212 (“Lumidigm”)
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`18. APPLE-1007: PCT Application Pub. No. WO 2005/092182
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`(“Kotanagi”)
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`19. APPLE-1008: US Pat. Appl. Pub. No. 9,820,658 (“Tran”)
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`20. APPLE-1009: US Pat. No. 5,766,131 (“Kondo”)
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`21. APPLE-1010: US Pat. No. 4,224,948 (“Cramer”)
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`22. APPLE-1011: US Pat. No. 7,060,963 (“Maegawa”)
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`23. APPLE-1012: Rachel A. Yotter and Denise Michelle Wilson, “A
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`Review of Photodetectors for Sensing Light-Emitting Reporters in Biological
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`Systems,” IEEE Sensors Journal, vol. 3, no. 3, pp. 288-303, June 2003
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`24. APPLE-1013: Design of Pulse Oximeters, J.G. Webster; Institution of
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`Physics Publishing, 1997 (“Webster”)
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`25. APPLE-1014: US Pat. No. 4,880,304 (“Nippon”)
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`26. APPLE-1015: US Pat. No. 5,893,364 (“Haar”)
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`27. APPLE-1020: US Pat. No. 6,527,711 (“Stivoric”)
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`28. APPLE-1021: US Pat. Appl. Pub. No. 2005/0007582 (“Villers”)
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`8
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`29. APPLE-1022: US Pat. No. 5,137,364 (“McCarthy”)
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`30. APPLE-1023: US Pat. No. 6,801,799 (“Mendelson ’799”)
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`31. APPLE-1024: US Pat. Appl. Pub. No. 2002/0188210 (“Aizawa”)
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`32. APPLE-1025: US Pat. No. 6,330,468 (“Scharf”)
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`33. APPLE-1026: US Pat. No. 7,613,504 (“Rowe”)
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`34.
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`I have also reviewed various supporting references and other
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`documentation as further noted in my opinions below.
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`35. 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 ’501 Patent at the
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`time of the earliest possible priority date of the ’501 Patent, and I have done so
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`during my review of these materials. The ’501 Patent claims the benefit of priority
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`to a provisional application filed July 3, 2008 (“the Critical Date”). Counsel has
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`informed me that the Critical Date represents the earliest possible priority date to
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`which the challenged claims of ’501 Patent are entitled, and I have therefore used
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`that Critical Date in my analysis below.
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`36.
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`I have no financial interest in the parties 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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`37.
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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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`38. My opinions, as explained below, are based on my education,
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`experience, and expertise in the fields relating to the ’501 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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`art as of the Critical Date, or before. Any figures that appear within this document
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`have been prepared with the assistance of Counsel and reflect my understanding of
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`the ’501 Patent and the prior art discussed below.
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`II. OVERVIEW OF CONCLUSIONS FORMED
`39. This declaration explains the conclusions that I have formed based on
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`my analysis. To summarize those conclusions, based upon my knowledge and
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`experience and my review of the prior art publications listed above, I believe that:
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`• Claims 1, 2, 5, 7, 8, 11-19, 22, and 25 are obvious over Lumidigm,
`
`Scharf, and Kotanagi; and
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`• Claims 3-4, 6, 9-10, 20-21, 23-24, and 26-30 are obvious over
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`Lumidigm, Scharf, Kotanagi, and Tran.
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`10
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`III. LEVEL OF ORDINARY SKILL IN THE ART
`40.
`In my opinion, a person of ordinary skill in the art as of the Critical
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`Date of the ’501 Patent (hereinafter a “POSITA”)would have been a person with a
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`working knowledge of physiological monitoring technologies. The person would
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`have had a Bachelor of Science degree in an academic discipline emphasizing the
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`design of electrical, computer, or software technologies, in combination with
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`training or at least one to two years of related work experience with capture and
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`processing of data or information, including but not limited to physiological
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`monitoring technologies. Alternatively, the person could have also had a Master of
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`Science degree in a relevant academic discipline with less than a year of related
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`work experience in the same discipline.
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`41. Based on my experiences, I have a good understanding of the
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`capabilities of one of ordinary skill. Indeed, I have taught, participated in
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`organizations, and worked closely with many such persons over the course of my
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`career. Based on my knowledge, skill, and experience, I have an understanding of
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`the capabilities of one of ordinary skill. For example, from my industry
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`experience, I am familiar with what an engineer would have known and found
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`predictable in the art. From teaching and supervising my post-graduate students, I
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`also have an understanding of the knowledge that a person with this academic
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`experience possesses. Furthermore, I possess those capabilities myself.
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`IV. THE ’501 PATENT
`A. Overview
`42. The system described by the ’501 Patent is said to include, in one
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`embodiment, “a noninvasive sensor and a patient monitor communicating with the
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`noninvasive sensor.” APPLE-1001, 2:47-60. The exemplary data collection
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`system 100 illustrated by the ’501 Patent’s FIG. 1 (reproduced below) includes “a
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`sensor 101 … that is coupled to a processing device or physiological monitor 109.”
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`Id., 5:44-47, 11:56-58.
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`APPLE-1001, FIG. 1.
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`12
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`43.
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`“The non-invasive sensor may include different architectures,” and
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`the “patient monitor” with which the sensor communicates may “include a display
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`device,” and “a network interface communicating with any one or combination of a
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`computer network, a handheld computing device, a mobile phone, the Internet, or
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`the like.” Id., 2:47-60; 3:50-56.
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`44. The ’501 Patent describes several sensor configurations with respect
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`to FIGS. 14A-14I. APPLE-1001, 6:48-51, 35:51-38:36. For example, the ’501
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`Patent’s FIG. 14C (reproduced below) illustrates a sensor featuring a “detector
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`submount 1400c … positioned under [a] protrusion 605b in a detector subassembly
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`1450 illustrated in FIG. 14D” (also reproduced below).
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`APPLE-1001, FIGS. 14C, 14D.
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`13
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`45. As illustrated in FIG. 14D, a housing 1430 including “a transparent
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`cover 1432, upon which the protrusion 605b is disposed” surrounds each of the
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`detectors 1410c. APPLE-1001, 36:45-56.
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`V.
`
`PRIOR ART ANALYSIS
`A.
`[GROUND 1A] – CLAIMS 1, 2, 5, 7-8, 11-19, 22, AND 25
`ARE OBVIOUS OVER LUMIDIGM, SCHARF, AND
`KOTANAGI
`46. The sections below provide a brief introduction to Lumidigm, Scharf,
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`Kotanagi, and the combination thereof.
`
`1.
`
`Lumidigm describes a wristwatch having an optical
`sensor
`47. Lumidigm describes “electro-optical sensors for use in biometric
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`analysis of optical spectra of tissue.” APPLE-1006, 1:53-56. These sensors can be
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`“built into the case of a wristwatch 112 and operates based upon signals detected
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`from the skin in the area of the wrist.” Id., 11:61-64, Fig. 8B (below). For
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`instance, Lumidigm’s sensor can be used to obtain data indicative of spectroscopic
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`characteristics of a patient’s blood or skin, which in turn can be used to determine
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`physiological parameters of the patient, such as the patient’s hemoglobin or
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`bilirubin levels or skin characteristics. See id., 3:44-45, 19:16-40.
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`14
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`Lumidigm, Fig. 8B
`48. Lumidigm describes various “sensor geometries,” discussed in the
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`following paragraphs, any of which can be implemented in the wristwatch context.
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`APPLE-1006, 11:66-12:2. Regardless of the particular sensor geometry, the
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`“illumination 104 and detection system 106” of the sensor are built into” the
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`wristwatch, “as are the data collection and digitization devices for collecting and
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`digitizing the spectral information.” Id., 11:35-38; see 11:64-65.
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`49. Fig. 2, below, shows a cross-sectional view of an example sensor head
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`32 disposed in contact with tissue 40 of a user. See APPLE-1006, 7:5-7. The
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`sensor head includes multiple light sources 41-51 (red), such as light emitting
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`diodes (LEDs) or “sets of LEDs,” and “one or more detectors 36” (blue). See id.,
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`6:22-24, 6:38-64, 7:9-10.
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`15
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`Lumidigm, Fig. 2 (annotated)
`50. The sensor “acquir[es] tissue spectral data” by detecting light from the
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`light sources that travels through the tissue and is reflected back to the detector, as
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`illustrated by the “mean optical paths” See id., 42-52 in Fig. 2, 7:8-11. “[W]hen
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`the tissue is illuminated by a particular light source 41, the resulting signal detected
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`by detector 36 contains information about the tissue optical properties.” Id., 7:26-
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`29. Specifically, “[o]nce the light passing through the tissue is detected, the
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`signals can be digitized and recorded,” and “[t]he recorded data can then be …
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`used for spectral identification or verification.” Id., 9:58-63.
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`51. The detector is recessed from the sensor surface 39 “in optically
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`opaque material 37 [green in Fig. 2, above] that makes up the body of the sensor
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`head,” with an opening above the detector that extends to the sensor surface 39 to
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`16
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`allow light to reach the detector. Id., 7:64-8:4. The recessed placement of
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`Lumidigm’s detector “minimizes the amount of light that can be detected after
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`reflecting off the first (epidermal) surface of the tissue.” Id., 8:4-7. Moreover,
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`Lumidigm’s sensor head may “have a compound curvature on the optical surface,”
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`i.e., the sensor surface 39, “to incorporate ergonomic features that allow for good
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`optical and mechanical coupling with the tissue being measured.” APPLE-1006,
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`7:58-63.
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`52. Lumidigm describes various characteristics and arrangements of the
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`light sources and detectors in its sensor heads. See, e.g., APPLE-1006, 6:43-62,
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`8:33-9:57, Figs. 3-7B. For instance, Lumidigm’s light sources “can each have the
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`same wavelength” or “can include some sources that have the same wavelengths as
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`others and some sources that are different,” and can be “sets of LEDs … with
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`differing wavelength characteristics.” Id., 6:43-48. The detector 36 “may
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`comprise a single element, a plurality of discrete elements, or a one-or two-
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`dimensional array of elements.” Id., 6:54-56. Lumidigm explains that
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`“[d]ifferences in both wavelength characteristics and source-detector separation
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`provide useful information about the optical characteristics of the tissue 40.” Id.,
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`7:50-53; see 7:34-50.
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`53. Example arrangements of the light sources and detectors for
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`Lumidigm’s biometric sensor are illustrated in Figs. 6 and 7A-7B, below. In the
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`arrangement of Fig. 6, “each of three different light sources 82, 84, 86 [red] is
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`positioned relative to three detectors 81, 83, 85 [blue].” APPLE-1006, 9:15-17.
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`Fig. 7A shows a sensor that “includes a row of detectors 95,” blue, “surrounded on
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`either side by rows of light sources 93,” some of which are marked in red; and
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`FIG. 7B shows a sensor in which “multiple light sources” 92-98, red, “are placed at
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`the perimeter of a detector array 99.” APPLE-1006, 9:28-39.
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`Lumidigm, Figs. 6 and 7A-7B (annotated)
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`19
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`2.
`Scharf describes pulse oximeters having glass covers
`54. Scharf is directed to “a pulse oximeter using two green light sources
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`to detect the oxygen saturation of hemoglobin in a volume of intra vascular blood.”
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`APPLE-1025, 1:10-13. As shown in Fig. 4, below, Scharf’s oximeter includes
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`“[s]urface mount LEDs,” red, that emit at certain wavelengths to generate
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`backscattered signals that are detected by a “photodiode 26 of a light-to-frequency
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`converter (LFC) 28,” blue. Id., 8:38-41, 5:19-23.
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`55. Scharf’s LEDs and photodiode are disposed within cavities covered
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`by a “face 88 of the oximeter probe.” APPLE-1025, 3:44-45. The “clear face 88,”
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`orange, “can be made in a single piece (including pieces 16, 18, and 91). Id., 8:57-
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`66. Alternatively, “[a]lthough shown as flat surfaces, face pieces 16, 18, and 91
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`can … be shaped to form discrete lenses … to focus the radiant energy from the
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`LEDs … onto the skin … and from the skin 2 onto the photodiode.” Id., 9:1-5.
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`The face 88 “can be made of glass.” Id., 9:13-15.
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`20
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`Scharf, Fig. 4 (annotated)
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`3.
`
`Kotanagi describes an optical sensor that protrudes
`from a bottom surface of a wristwatch
`56. Kotanagi describes “a biological information measuring device
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`capable of measuring biological information such as pulse rate while mounted to
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`the wrist.” APPLE-1007, [0001]. The biological information measuring device,
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`illustrated in Fig. 5, below, has a housing 2 with “a protruding part 4 [circled in
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`green] which protrudes from the lower surface 2a” of the housing. Id., [0045]. “A
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`biological sensor part 8” “is disposed on the lower surface 4a of the protruding part
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`4.” Id., [0046]. The biological sensor part includes an LED 5 (red) “for emitting
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`light toward the living body while in contact with the living body surface,” and a
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`photodetector 6 (blue) “for receiving reflected light from the living body … and
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`generating a pulse signal (biological information signal)” based on the received
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`light. Id., [0046]. A data processing part contained in the housing “detect[s] pulse
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`rate based on the generated pulse signal.” Id., [0047].
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`
`Kotanagi, Fig. 5 (annotated)
`In one implementation, illustrated in Fig. 10, below, “a curved surface
`
`57.
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`may be formed from the center toward the outer edge of the lower surface 4a of the
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`protruding part 4.” APPLE-1007, [0080]. The convex profile of the protruding
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`part 4 allows the watch to be “mounted in a state in which the living body surface
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`B deforms smoothly and the contact pressure of the center part of the lower surface
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`22
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`

`
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`4a is increased, which further enhances adherence.” Id., [0080]. In addition, with
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`such a convex profile, “pressure marks are unlikely to form, so the device is
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`comfortable to wear.” Id., [0080].
`
`Kotanagi, Fig. 10 (annotated)
`
`
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`23
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`

`

`
`
`The combination of Lumidigm, Scharf, and Kotanagi
`
`4.
`The structure of the combination device
`i.
`58. A user-worn optical sensor based on the Lumidigm-Scharf-Kotanagi
`
`combination is shown in the following composite figure:
`
`
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`24
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`

`

`
`
` Lumidigm-Scharf-Kotanagi Composite Figure1,2
`
`59. The following description of the combined sensor references this
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`composite figure.
`
`60.
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`In the combination, the optical sensor is “built into the case of a
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`wristwatch,” and, as shown above, includes LEDs or sets of LEDs (annotated in
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`red), as well as detectors (blue) “recessed from the sensor surface 39 in optically
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`opaque material” (green), as described in Lumidigm. APPLE-1006, 8:1-10, 11:60-
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`12:1; see 6:38-63.
`
`61. Also in the combination, the detectors in the combined optical sensor
`
`are implemented as photodiodes. Indeed, a POSITA would have understood or
`
`found obvious that Lumidigm’s semiconductor-based photodetectors are
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`photodiodes. See APPLE-1006, 6:58-63. Alternatively or additionally, in the
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`combination, Lumidigm’s photodetectors are implemented as photodiodes based
`
`
`
`1 The composite figures in this declaration are example combinations that a
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`POSITA would have found to be obvious, and are provided for illustrative
`
`purposes. Other examples could be conceived that are also obvious and that would
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`similarly render the challenged claims obvious.
`
`2 This and other composite figures are not engineering drawings and are not
`
`drawn to scale. They are provided for illustration only.
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`25
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`
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`on Scharf’s teaching of the use of photodiodes in a reflectance pulse oximetry. See
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`APPLE-1025, 2:63-65, 3:5-9, 5:19-21.
`
`62. The optical surface of the combined device is implemented as a
`
`“curved surface … formed from the center toward the outer edge” of the optical
`
`surface of the sensor, as described in Kotanagi. APPLE-1007, [0080]; see APPLE-
`
`1006, 7:58-63. Consistent with Kotanagi’s curved protruding part 4, this curved
`
`optical surface forms a protrusion with a convex outer surface (indicated in green)
`
`extending over the photodiodes and LEDs of the sensor. See APPLE-1007, [0080],
`
`Fig. 10. That is, in the combination device, the optically opaque material (green)
`
`that forms a portion of the body of Lumidigm’s unmodified sensor (see APPLE-
`
`1006, 8:3-4) extends from the bottom surface of the sensor to the convex surface
`
`(outlined in green) of the protrusion.
`
`63. As described in Lumidigm, the photodiodes are recessed into the
`
`protrusion, and a recess aligned with each photodiode extends from the bottom
`
`surface of the sensor, through the protrusion, and to the convex optical surface.
`
`See APPLE-1006, 7:5-10, 8:1-10. This positioning “minimizes the amount of light
`
`that can be detected after reflecting off the first (epidermal) surface of the tissue.”
`
`Id., 8:4-7. The LEDs are also recessed into the protrusion, with recesses for the
`
`LED also extending through the protrusion, as indicated by the dashed lines in the
`
`composite figure, above. See id., 8:7-10 (“the same optical blocking effect could
`
`26
`
`

`

`
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`be produced … by recessing both the detector and the light sources”). Moreover,
`
`the outer edges of the protrusion are chamfered, as also shown in the composite
`
`figure.
`
`64. A “clear face,” as taught by Scharf, covers the convex surface of the
`
`combination device. APPLE-1025, 8:57-66. The face is implemented as a single
`
`piece, or alternatively, as discrete covers (orange in the composite figure above)
`
`formed over the recesses in the protrusion, e.g., substantially flush with the convex
`
`optical surface of the protrusion. Id., 8:57-9:15.
`
`ii. The arrangement of LEDs and photodiodes in the combination device
`65.
`In the combination, the LEDs light sources and detectors photodiodes
`
`are arranged, alternatively, according to the arrangements shown in Lumidigm’s
`
`Fig. 6 and Fig. 7A, or according to a modified arrangement based on that of
`
`Lumidigm’s Fig. 7B, or other similar arrangements. See APPLE-1006, 9:32-34
`
`(“other numbers and arrangements of the sources 93 and detectors 95 may
`
`alternatively be used”).
`
`66. With respect to Fig. 6, Lumidigm describes that the sensor includes
`
`“each of three different light sources,” such as LEDs or sets of LEDs (red),
`
`“positioned relative to three detectors.” Id., 9:15-17, FIG. 6. This arrangement is
`
`shown below in the annotated version of Lumidigm’s Fig. 6 and composite figure
`
`showing a cross-section of Fig. 6:
`
`27
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`

`

`
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`
`
`Left: Lumidigm, Fig. 6 (annotated); Right: Lumidigm-Scharf-Kotanagi composite
`figure based on A-Aʹ cross-section (not to scale)
`67. Also in the combination, with respect to Fig. 7A, Lumidigm describes
`
`that the sensor “includes a row of detectors surrounded on either side by rows of
`
`light sources,” such as LEDs or sets of LEDs (red). APPLE-1006, 9:26-34, FIG.
`
`7A. Top and cross-sectional views of this configuration are shown in the
`
`following composite figure:
`
`28
`
`

`

`
`
`Left: Lumidigm, Fig. 7A (annotated); Right: Lumidigm-Scharf-Kotanagi
`composite figure based on B-Bʹ cross-section (not to scale)
`68. With respect to Fig. 7B, Lumidigm describes that a sensor includes
`
`“multiple light sources 92, 94, 96, 98 [that] are placed at the perimeter of a detector
`
`array 99.” APPLE-1006, 9:34-39. In the combination, this arrangement is
`
`modified to include fewer than all of the photodiodes in the array, as shown in the
`
`composite figures below. See APPLE-1006, 9:42-45.
`
`29
`
`

`

`
`
`
`
`Left: Composite figure based on Lumidigm, Fig. 7B; Right: Lumidigm-Scharf-
`Kotanagi composite figure based on C-Cʹ cross-section (not to scale)
`69. As shown in the composite cross-section figures above, in each
`
`alternative arrangement, each photodiode (blue) is separately recessed into the
`
`protrusion, and a cover (orange) extends over each recess. See APPLE-1006, 7:5-
`
`10, 8:1-10; APPLE-1025, 9:1-15.
`
`5.
`Reasons to combine Lumidigm, Scharf, and Kotanagi
`70. A POSITA would have been motivated to implement the Lumidigm-
`
`Scharf-Kotanagi combination described in the preceding section for at least the
`
`following reasons.
`
`30
`
`

`

`
`
`A POSITA would have been motivated to arrange the LEDs and detectors
`according to the arrangements in Lumidigm’s Figs. 6 or 7A, or according to a
`modified arrangement based on Lumidigm’s Fig. 7B
`71. As discussed above, in the combination, the LEDs and detector are
`
`arranged according to the arrangement of Lumidigm’s Fig. 6 or 7A. A POSITA
`
`would have been motivated to pursue this modification for at least the following
`
`reasons.
`
`72. First, a POSITA would have been motivated to pursue this
`
`implementation to achieve the advantages of the arrangements of Figs. 6 or 7A,
`
`both of which “provide multiple source-detector distances.” APPLE-1006, 9:26-
`
`28; see 9:12-25. The various source-detector separations available from the
`
`arrangements of Figs. 6 and 7A “provide useful information abo