throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Jeroen Poeze et al.
`In re Patent of:
`10,588,554 Attorney Docket No.: 50095-00013IP2
`U.S. Patent No.:
`March 17, 2020
`
`Issue Date:
`Appl. Serial No.: 16,544,713
`
`Filing Date:
`August 19, 2019
`
`Title:
`MULTI-STREAM DATA COLLECTION SYSTEM FOR
`NONINVASIVE MEASUREMENT OF BLOOD
`CONSTITUENTS
`
`
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`
`
`Declaration
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`DECLARATION OF DR. THOMAS W. KENNY
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`I declare that all statements made herein on my own knowledge are true and
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`that all statements made on information and belief are believed to be true, and
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`further, that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable under Section 1001 of Title 18 of
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`the United States Code.
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`By: ________________________________
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`
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`Thomas W. Kenny, Ph.D.
`
`1
`
`APPLE 1048
`Apple v. Masimo
`IPR2021-00208
`
`

`

`Contents
`
`1.
`2.
`3.
`4.
`
`
`QUALIFICATIONS AND BACKGROUND INFORMATION ... 3
`I.
`OVERVIEW OF CONCLUSIONS FORMED ............................... 9
`II.
`LEVEL OF ORDINARY SKILL IN THE ART ............................ 9
`III.
`LEGAL STANDARDS ................................................................. 10
`IV.
`Terminology .................................................................................. 10
`A.
`Legal Standards for Anticipation .................................................. 11
`B.
`Legal Standards for Obviousness .................................................. 12
`C.
`THE ’554 PATENT....................................................................... 16
`V.
`Overview of the ’554 Patent .......................................................... 17
`A.
`Prosecution History of the ’554 Patent ......................................... 27
`B.
`SUMMARY OF THE PRIOR ART ............................................. 28
`VI.
`Overview of Aizawa ...................................................................... 28
`A.
`Overview of Inokawa .................................................................... 30
`B.
`Overview of Ohsaki....................................................................... 33
`C.
`Overview of Mendelson 2006 ....................................................... 34
`D.
`Overview of Bergey ...................................................................... 36
`E.
`GROUND 1 – Claims 1-7 and 20-28 are Rendered Obvious by
`VII.
`Aizawa, Inokawa, Ohsaki, and Mendelson 2006..................................................... 37
`A.
`Combination of Aizawa, Inokawa, Ohsaki, and Mendelson 200637
`Plurality of emitters ....................................................................... 37
`Transmission of information ......................................................... 42
`Convex surface .............................................................................. 50
`Substrate ........................................................................................ 55
`Claim 1 .......................................................................................... 58
`Claim 2 ........................................................................................112
`Claim 3 ........................................................................................114
`Claim 4 ........................................................................................116
`Claim 5 ........................................................................................119
`Claim 6 ........................................................................................124
`Claim 7 ........................................................................................128
`
`B.
`C.
`D.
`E.
`F.
`G.
`H.
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`1
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`2
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`

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`Claim 20 ......................................................................................130
`I.
`Claim 21 ......................................................................................135
`J.
`Claim 22 ......................................................................................140
`K.
`Claim 23 ......................................................................................142
`L.
`Claim 24 ......................................................................................143
`M.
`Claim 25 ......................................................................................144
`N.
`Claim 26 ......................................................................................147
`O.
`Claim 27 ......................................................................................148
`P.
`Claim 28 ......................................................................................150
`Q.
`GROUND 2 – Claims 8-19 are Rendered Obvious by Aizawa,
`VIII.
`Inokawa, Ohsaki, Mendelson 2006, and Bergey ...................................................152
`A.
`Combination of Aizawa, Inokawa, Ohsaki, Mendelson 2006, and
`Bergey
`152
`B.
`Claim 8 ........................................................................................154
`C.
`Claim 9 ........................................................................................156
`D.
`Claim 10 ......................................................................................157
`E.
`Claim 11 ......................................................................................157
`F.
`Claim 12 ......................................................................................158
`G.
`Claim 13 ......................................................................................160
`H.
`Claim 14 ......................................................................................162
`I.
`Claim 15 ......................................................................................163
`J.
`Claim 16 ......................................................................................165
`K.
`Claim 17 ......................................................................................166
`L.
`Claim 18 ......................................................................................167
`M.
`Claim 19 ......................................................................................168
`IX.
`CONCLUSION ...........................................................................169
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`2
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`3
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`I.
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`QUALIFICATIONS AND BACKGROUND INFORMATION
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`1. My education and experience are described more fully in the attached
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`curriculum vitae (Exhibit 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, Exhibit 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, Minneapolis in
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`1983, and a Ph.D. in Physics from University of California at Berkeley in 1989. I
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`was educated as a Physicist specializing in sensors and measurement. My Physics
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`Ph.D. thesis involved measurements of the heat capacity of monolayers of atoms
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`on surfaces, and relied on precision measurements of temperature and power using
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`time-varying electrical signals, and also on the design and construction of
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`miniature sensor components and associated electrical circuits for conditioning and
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`conversion to digital format.
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`3
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`4
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`

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`4.
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`After completion of my Ph.D. in Physics at U.C. Berkeley in 1989, I joined
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`the Jet Propulsion Laboratory (JPL) in Pasadena, CA, as a staff scientist, and began
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`working on miniature sensors and instruments for small spacecraft. This work
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`involved the use of silicon microfabrication technologies for miniaturization of the
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`sensors, and served as my introduction to the field of micro-electromechanical
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`systems (MEMS), or the study of very small mechanical sensors powered by
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`electricity and used for detection of physical and chemical signals.
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`5. While at JPL, we developed accelerometers, uncooled infrared sensors,
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`magnetometers, seismometers, force and displacement sensors, soil chemistry
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`sensors, miniature structures for trapping interstellar dust, and many other
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`miniature devices. Some of these projects led to devices that were launched with
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`spacecraft headed for Mars and for other interplanetary missions. Much of this
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`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 26 years, I have taught courses on Sensors and Mechatronics at Stanford
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`University. The “Introduction to Sensors” course is a broad overview of all
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`4
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`5
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`

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`sensing technologies, from thermometers, to inertial sensors, ultrasound devices,
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`flow sensors, optical and IR sensors, chemical sensors, pressure sensors, and many
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`others, and has included sensors based on changes in capacitance, resistance,
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`piezoelectricity. This course specifically included different mechanisms for
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`sensing heart rate, blood pressure, blood chemistry, cardiovascular blood flow and
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`pressure drops, intraocular pressure and other physiological measurements, as well
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`as activity monitoring (step counting, stair-counting, etc). I first taught this course
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`at Stanford in the Spring of 1994, and I offered this course at least annually until
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`2016, when my duties as Senior Associate Dean made this impractical.
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`8.
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`The “Introduction to Mechatronics” course is a review of the mechanical,
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`electrical and computing technologies necessary to build systems with these
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`contents, which include everything from cars and robots to cellphones and other
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`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 2020 offering was just completed, and was
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`highly-successful with 120 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 Design,”
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`which broadly covers the topic of integration of mechanical, electronic and
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`computer systems design into “smart products.” This textbook includes chapters
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`on Microprocessors, Programming Languages, Software Design, Electronics,
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`Sensors, Signal Conditioning, and Motors, as well as topics such as Project
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`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.
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`I have advised 69 Ph.D. students that have completed Ph.D. degrees and
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`many more M.S. and B.S. students in Engineering during my time at Stanford.
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`12.
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`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.
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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, Exhibit 1004, includes a full listing of all cases in
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`which I have testified at deposition or trial in the preceding four years.
`
`14.
`
`I have been retained on behalf of Apple Inc. to offer technical opinions
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`relating to U.S. Patent No. 10,588,554 (“the ’554 Patent”) and prior art references
`
`relating to its subject matter. I have reviewed the ’554 Patent, relevant excerpts of
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`the prosecution history of the ’554 Patent. I have also reviewed the following prior
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`art references:
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`Prior Art Reference
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`U.S. Pub. No. 200/0188210 to Aizawa (“Aizawa”)
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`JP Pub. No. 2006/0296564 to Inokawa et al. (“Inokawa”)
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`U.S. Pub. No. 2001/0056243 to Ohsaki et al. (“Ohsaki”)
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`
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`7
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`8
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`

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`“A Wearable Reflectance Pulse Oximeter for Remote Physiological
`Monitoring,” Y. Mendelson, et al.; Proceedings of the 28th IEEE
`EMBS Annual International Conference, 2006; pp. 912-915
`(“Mendelson 2006”)
`U.S. Patent No. 3,789,601 (“Bergey”)
`
`15. Counsel has informed me that I should consider these materials through the
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`lens of one of ordinary skill in the art related to the ’554 Patent at the time of the
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`earliest possible priority date of the ’554 Patent, and I have done so during my
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`review of these materials. The application leading to the ’554 Patent was filed on
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`August 7, 2019 and claims the benefit of priority to a provisional application filed
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`July 3, 2008 (“the Critical Date”). Counsel has informed me that the Critical Date
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`represents the earliest possible priority date to which the challenged claims of ’554
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`Patent are entitled, and I have therefore used that Critical Date in my analysis
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`below.
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`16.
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`I have no financial interest in the party or in the outcome of this proceeding.
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`I am being compensated for my work as an expert on an hourly basis. My
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`compensation is not dependent on the outcome of these proceedings or the content
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`of my opinions.
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`17.
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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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`engineer; my experience in teaching those subjects; and my experience in working
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`9
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`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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`18. My opinions, as explained below, are based on my education, experience,
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`and expertise in the fields relating to the ’554 Patent. Unless otherwise stated, my
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`testimony below refers to the knowledge of one of ordinary skill in the fields as of
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`the Critical Date, or before. Any figures that appear within this document have
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`been prepared with the assistance of Counsel and reflect my understanding of the
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`’554 Patent and the prior art discussed below.
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`II. OVERVIEW OF CONCLUSIONS FORMED
`19. This declaration explains the conclusions that I have formed based on my
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`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 1-7 and 20-28 are rendered obvious by Aizawa, Inokawa, Ohsaki,
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`and Mendelson 2006.
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` Claims 8-19 are rendered obvious by Aizawa, Inokawa, Ohsaki, Mendelson
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`2006, and Bergey.
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`III. LEVEL OF ORDINARY SKILL IN THE ART
`20.
`In my opinion, one of ordinary skill in the art relating to, and at the time of,
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`the invention of the ’554 Patent would have been someone with a working
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`knowledge of physiological monitoring technologies. The person would have had
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`9
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`10
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`a Bachelor of Science degree in an academic discipline emphasizing the design of
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`electrical, computer, or software technologies, in combination with training or at
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`least one to two years of related work experience with capture and processing of
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`data or information, including but not limited to physiological monitoring
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`technologies. Alternatively, the person could have also had a Master of Science
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`degree in a relevant academic discipline with less than a year of related work
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`experience in the same discipline.
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`21. Based on my experiences, I have a good understanding of the capabilities of
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`one of ordinary skill. Indeed, I have taught, participated in organizations, and
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`worked closely with many such persons over the course of my career. Based on
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`my knowledge, skill, and experience, I have an understanding of the capabilities of
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`one of ordinary skill. For example, from my industry experience, I am familiar
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`with what an engineer would have known and found predictable in the art. From
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`teaching and supervising my post-graduate students, I also have an understanding
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`of the knowledge that a person with this academic experience possesses.
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`Furthermore, I possess those capabilities myself.
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`IV. LEGAL STANDARDS
`A. Terminology
`I have been informed by Counsel and understand that the best indicator of
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`22.
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`claim meaning is its usage in the context of the patent specification as understood
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`11
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`by one of ordinary skill. I further understand that the words of the claims should
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`be given their plain meaning unless that meaning is inconsistent with the patent
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`specification or the patent’s history of examination before the Patent Office.
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`Counsel has also informed me, and I understand that, the words of the claims
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`should be interpreted as they would have been interpreted by one of ordinary skill
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`at the time of the invention was made (not today). Because I do not know at what
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`date the invention as claimed was made, I have used the earliest possible priority
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`date of the ’554 Patent as the point in time for claim interpretation purposes. That
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`date was July 3, 2008, the Critical Date.
`
`B.
`Legal Standards for Anticipation
`I have been informed by Counsel and understand that documents and
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`23.
`
`materials that qualify as prior art can render a patent claim unpatentable as
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`anticipated. I am informed by Counsel and understand that all prior art references
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`are to be looked at from the viewpoint of a person of ordinary skill in the art.
`
`24.
`
`I am informed by Counsel and understand that a challenged claim is
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`unpatentable as “anticipated” under 35 U.S.C. § 102 if it is determined that all the
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`limitations of the claim are described in a single prior art reference. I am informed
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`by Counsel and understand that, to anticipate a claim, a prior art reference must
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`disclose, either expressly or inherently, each and every limitation of that claim and
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`enable one of ordinary skill in the art to make and use the invention.
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`11
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`12
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`25.
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`I have been informed by Counsel and understand that in an inter partes
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`review, “the petitioner shall have the burden of proving a proposition of
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`unpatentability,” including a proposition of anticipation, “by a preponderance of
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`the evidence.” 35 U.S.C. §316(e).
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`C. Legal Standards for Obviousness
`I have been informed by Counsel and understand that documents and
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`26.
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`materials that qualify as prior art can render a patent claim unpatentable as
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`obvious. I am informed by Counsel and understand that all prior art references are
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`to be looked at from the viewpoint of a person of ordinary skill in the art at the
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`time of the invention, and that this viewpoint prevents one from using his or her
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`own insight or hindsight in deciding whether a claim is obvious.
`
`27.
`
`I have been informed by Counsel and understand that a claim is unpatentable
`
`for obviousness under 35 U.S.C. § 103 (in the pre-AIA form of that statute that
`
`applies to the ’554 Patent) “if the differences between the subject matter sought to
`
`be patented and the prior art are such that the subject matter as a whole would have
`
`been obvious at the time the invention was made to a person having ordinary skill
`
`in the art to which said subject matter pertains.” I am informed by Counsel and
`
`understand that obviousness may be based upon a combination of references. I am
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`informed by Counsel and understand that the combination of familiar elements
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`according to known methods is likely to be obvious when it does no more than
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`12
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`13
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`yield predictable results. However, I am informed by Counsel and understand that
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`a patent claim composed of several elements is not proved obvious merely by
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`demonstrating that each of its elements was, independently, known in the prior art.
`
`28.
`
`I am informed by Counsel and understand that when a patented invention is
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`a combination of known elements, a court must determine whether there was an
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`apparent reason to combine the known elements in the fashion claimed by the
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`patent at issue by considering the teachings of prior art references, the effects of
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`demands known to people working in the field or present in the marketplace, and
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`the background knowledge possessed by a person having ordinary skill in the art.
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`29.
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`I am informed by Counsel and understand that a patent claim composed of
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`several limitations is not proved obvious merely by demonstrating that each of its
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`limitations was independently known in the prior art. I am informed by counsel for
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`the Patent Owner and understand that identifying a reason those elements would be
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`combined can be important because inventions in many instances rely upon
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`building blocks long since uncovered, and claimed discoveries almost of necessity
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`will be combinations of what, in some sense, is already known. I am informed by
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`Counsel and understand that it is improper to use hindsight in an obviousness
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`analysis, and that a patent’s claims should not be used as a “roadmap.”
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`30.
`
`I am informed by Counsel and understand that an obviousness inquiry
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`requires consideration of the following factors: (1) the scope and content of the
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`13
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`14
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`prior art; (2) the differences between the claims and the prior art; (3) the level of
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`ordinary skill in the pertinent art; and (4) any objective indicia of non-obviousness,
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`such as commercial success, long-felt but unresolved need, failure of others,
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`industry recognition, copying, and unexpected results. I understand that the
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`foregoing factors are sometimes referred to as the “Graham factors.”
`
`31.
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`I have been informed by Counsel and understand that an obviousness
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`evaluation can be based on a combination of multiple prior art references. I
`
`understand that the prior art references themselves may provide a suggestion,
`
`motivation, or reason to combine, but that the nexus linking two or more prior art
`
`references is sometimes simple common sense. I have been informed by Counsel
`
`and understand that obviousness analysis recognizes that market demand, rather
`
`than scientific literature, often drives innovation, and that a motivation to combine
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`references may be supplied by the direction of the marketplace.
`
`32.
`
`I have been informed by Counsel and understand that if a technique has been
`
`used to improve one device, and a person of ordinary skill at the time of invention
`
`would have recognized that it would improve similar devices in the same way,
`
`using the technique is obvious unless its actual application is beyond his or her
`
`skill.
`
`33.
`
`I have been informed by Counsel and understand that practical and common
`
`sense considerations should guide a proper obviousness analysis, because familiar
`
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`14
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`15
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`

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`items may have obvious uses beyond their primary purposes. I have been
`
`informed by Counsel and understand that a person of ordinary skill looking to
`
`overcome a problem will often be able to fit together the teachings of multiple
`
`prior art references. I have been informed by Counsel and understand that
`
`obviousness analysis therefore takes into account the inferences and creative steps
`
`that a person of ordinary skill would have employed at the time of invention.
`
`34.
`
`I have been informed by Counsel and understand that a proper obviousness
`
`analysis focuses on what was known or obvious to a person of ordinary skill at the
`
`time of invention, not just the patentee. Accordingly, I understand that any need or
`
`problem known in the field of endeavor at the time of invention and addressed by
`
`the patent can provide a reason for combining the elements in the manner claimed.
`
`35.
`
`I have been informed by Counsel and understand that a claim can be obvious
`
`in light of a single reference, without the need to combine references, if the
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`elements of the claim that are not found explicitly or inherently in the reference
`
`can be supplied by the common sense of one of skill in the art.
`
`36.
`
`I have been informed by Counsel and understand that secondary indicia of
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`non-obviousness may include (1) a long felt but unmet need in the prior art that
`
`was satisfied by the invention of the patent; (2) commercial success of processes
`
`covered by the patent; (3) unexpected results achieved by the invention; (4) praise
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`of the invention by others skilled in the art; (5) taking of licenses under the patent
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`15
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`16
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`by others; (6) deliberate copying of the invention; (7) failure of others to find a
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`solution to the long felt need; and (8) skepticism by experts. I understand that
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`evidence of secondary indicia of non-obviousness, if available, should be
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`considered as part of the obviousness analysis.
`
`37.
`
`I have been informed by Counsel and understand that there must be a
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`relationship between any such secondary considerations and the invention, and that
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`contemporaneous and independent invention by others is a secondary consideration
`
`supporting an obviousness determination.
`
`38.
`
`In sum, my understanding is that prior art teachings are properly combined
`
`where one of ordinary skill having the understanding and knowledge reflected in
`
`the prior art and motivated by the general problem facing the inventor, would have
`
`been led to make the combination of elements recited in the claims. Under this
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`analysis, the prior art references themselves, or any need or problem known in the
`
`field of endeavor at the time of the invention, can provide a reason for combining
`
`the elements of multiple prior art references in the claimed manner.
`
`39.
`
`I have been informed by Counsel and understand that in an inter partes
`
`review, “the petitioner shall have the burden of proving a proposition of
`
`unpatentability,” including a proposition of obviousness, “by a preponderance of
`
`the evidence.” 35 U.S.C. §316(e).
`
`V. THE ’554 PATENT
`
`
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`16
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`17
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`

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`A. Overview of the ’554 Patent
`40. Prior to the Critical Date of the ’554 Patent, numerous products,
`
`publications, and patents existed that implemented or described the functionality
`
`claimed in the ’554 Patent. The methodology of the ’554 Patent was therefore
`
`well-known in the prior art as of the Critical Date. Further, to the extent there was
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`any problem to be solved in the ’554 Patent, it had already been solved in the prior
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`art systems before the Critical Date of the ’554 Patent as I discuss below.
`
`41. The ’554 Patent relates to “noninvasive methods, devices, and systems for
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`measuring a blood constituent or analyte … or for measuring many other
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`physiologically relevant patient characteristics.” APPLE-1001, 2:29-37.
`
`42.
`
`In its background section, the ’554 Patent explains that “[t]he standard of
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`care in caregiver environments includes patient monitoring through spectroscopic
`
`analysis using, for example, a pulse oximeter,” and that “[d]evices capable of
`
`spectroscopic analysis generally include a light source(s) transmitting optical
`
`radiation into or reflecting off a measurement site, such as, body tissue carrying
`
`pulsing blood.” Id., 2:5-11. “After attenuation by tissue and fluids of the
`
`measurement site, a photo-detection device(s) detects the attenuated light and
`
`outputs a detector signal(s) responsive to the detected attenuated light.” Id., 2:11-
`
`14. “A signal processing device(s)” then “process[es] the detector(s) signal(s) and
`
`outputs a measurement indicative of a blood constituent of interest, … other
`
`
`
`17
`
`18
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`

`

`physiological parameters, or other data or combinations of data useful in
`
`determining a state or trend of wellness of a patient.” Id., 2:14-20.
`
`43.
`
`In this way, the ’554 Patent confirms that prior art “devices capable of
`
`spectroscopic analysis” (“for example, a pulse oximeter”), generally included one
`
`or more light sources configured to emit light into user tissue, one or more
`
`detectors configured to detect light after attenuation by the user’s tissue and to
`
`output responsive signal(s), and one or more signal processors configured to
`
`process signals and to output measurements of physiological parameters. Id., 2:5-
`
`20.
`
`44. The system described by the ’554 Patent is said to include, in one
`
`embodiment, “a noninvasive sensor and a patient monitor communicating with the
`
`noninvasive sensor.” APPLE-1001, 2:38-40. The ’554 Patent explains that “[t]he
`
`non-invasive sensor may include different architectures,” adding that “an artisan
`
`will recognize that the non-invasive sensor may include or may be coupled to other
`
`components, such as a network interface, and the like.” Id., 2:40-44. The “patient
`
`monitor” with which the sensor communicates may itself “include a display
`
`device,” and “a network interface communicating with any one or combination of a
`
`computer network, a handheld computing device, a mobile phone, the Internet, or
`
`the like.” Id., 2:45-48.
`
`
`
`18
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`19
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`

`

`45.
`
`In more detail, the exemplary physiological measurement system 100
`
`illustrated by the ’554 Patent’s FIG. 1 (reproduced below) includes “a sensor 101
`
`… that is coupled to a processing device or physiological monitor 109.” Id., 5:35-
`
`38, 11:47-49.
`
`
`
`APPLE-1001, FIG. 1.
`
`46. The ’554 Patent explains that “[i]n an embodiment, the sensor 101 and the
`
`monitor 109 are integrated together into a single unit.” Id., 11:49-51. “In another
`
`embodiment, the sensor 101 and the monitor 109 are separate from each other and
`
`communicate one with another in any suitable manner, such as via a wired or
`
`wireless connection.” Id., 11:51-54. “The sensor 101 and monitor 109 can be,” for
`19
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`
`20
`
`

`

`example, “attachable and detachable from each other for the convenience of the
`
`user or caregiver, for ease of storage, sterility issues, or the like.” Id., 11:54-57.
`
`47. From this and related description, one of ordinary skill would have
`
`understood that the sensor 101 and monitor 109 described by the ’554 Patent
`
`together act as components of a physiological sensor device, regardless of whether
`
`they are integrated into a single unit, or are instead separated but configured to
`
`communicate with each other. APPLE-1001, 2:38-48, 11:49-57, 16:20-18:28,
`
`FIGS. 1, 2A-2D.
`
`48.
`
`In more detail, the ’554 Patent’s FIGS. 2A-2D (reproduced below) illustrate
`
`“example monitoring devices 200 in which the data collection system 100 can be
`
`housed.” APPLE-1001, 5:39-42, 16:20-31.
`
`
`
`20
`
`21
`
`

`

`
`
`APPLE-1001, FIGS. 2A-2D.
`
`49. Each of the illustrated “monitoring devices 200” include a sensor 201 and a
`
`monitor 209. Id., FIGS. 2A-2D, 16:20-18:28. “Referring specifically to FIG. 2A,”
`
`for example, the “monitoring device 200A is shown, in which a sensor 201a and a
`
`monitor 209a are integrated into a single unit.” Id. 16:32-40. FIG. 2D illustrates a
`
`different “monitoring device 200D [that] includes a finger clip sensor 201d
`
`connected to a monitor 209d via a cable 212,” in addition to “an optional universal
`
`serial bus (USB) port 216 and an Ethernet port 218 [that] can be u

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