`
`Poeze et al.
`In re Patent of:
`U.S. Patent No.:
`10,299,708 Attorney Docket No.: 50095-00009IP1
`May 28, 2019
`Issue Date:
`Appl. Serial No.: 16/261,366
`Filing Date:
`May 10, 2019
`Title:
`MULTI-STREAM DATA COLLECTION SYSTEM FOR
`NONINVASIVE MEASUREMENT OF BLOOD
`CONSTITUENTS
`
`DECLARATION OF DR. THOMAS W. KENNY
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`Declaration
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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.
`
`By: ________________________________
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`Thomas W. Kenny, Ph.D.
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`1
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`APPLE 1003
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`
`
`Contents
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`
`I. QUALIFICATIONS AND BACKGROUND INFORMATION ........................ 5
`II. OVERVIEW OF CONCLUSIONS FORMED ................................................. 12
`III. LEVEL OF ORDINARY SKILL IN THE ART ............................................... 13
`IV. LEGAL STANDARDS ..................................................................................... 14
`A. Terminology ................................................................................................... 14
`B. Legal Standards for Anticipation.................................................................... 15
`C. Legal Standards for Obviousness ................................................................... 15
`V. HISTORICAL AND TECHNICAL OVERVIEW ............................................ 20
`VI. THE ’708 patent ................................................................................................ 21
`A. Overview of the ’708 patent ........................................................................... 21
`VII. SUMMARY OF THE PRIOR ART ................................................................. 26
`A. Overview of Aizawa ....................................................................................... 26
`B. Overview of Inokawa ..................................................................................... 29
`C. Overview of Ohsaki ........................................................................................ 33
`D. Overview of Mendelson-1988 ........................................................................ 35
`E. Overview of Mendelson-2006 ........................................................................ 37
`F. Overview of Beyer, Jr. .................................................................................... 41
`VIII. GROUND 1A – Claims 1-4, 6-11, 13-15, 19-22, and 24-27 Are Rendered
`Obvious by Aizawa in view of Inokawa .................................................................. 42
`A. Claim 1 ........................................................................................................... 42
`B. Claim 2 ........................................................................................................... 54
`C. Claim 3 ........................................................................................................... 56
`D. Claim 4 ........................................................................................................... 56
`E. Claim 5 ........................................................................................................... 57
`F. Claim 6 ........................................................................................................... 58
`G. Claim 7 ........................................................................................................... 60
`H. Claim 8 ........................................................................................................... 61
`I. Claim 9 ........................................................................................................... 63
`J. Claim 11 ......................................................................................................... 65
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`2
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`K. Claim 13 ......................................................................................................... 65
`L. Claim 14 ......................................................................................................... 66
`M. Claim 15 ......................................................................................................... 67
`N. Claim 19 ......................................................................................................... 68
`O. Claim 20 ......................................................................................................... 71
`P. Claim 21 ......................................................................................................... 71
`Q. Claim 22 ......................................................................................................... 72
`R. Claim 24 ......................................................................................................... 72
`S. Claim 25 ......................................................................................................... 72
`T. Claim 26 ......................................................................................................... 73
`U. Claim 27 ......................................................................................................... 74
`IX. GROUND 1B –Claims 1-4, 6-11, 13-15, 19-22, and 24-27 Are Rendered
`Obvious by Aizawa in view of Inokawa and Ohsaki .............................................. 74
`A. Claims 1-4, 6-11, 13-15, 19-22, and 24-27 .................................................... 74
`X. GROUND 1C – Claims 16, 27, and 28 Are Rendered Obvious by Aizawa in
`view of Inokawa and Mendelson-2006 .................................................................... 77
`A. Claim 16 ......................................................................................................... 77
`B. Claim 27 ......................................................................................................... 81
`C. Claim 28 ......................................................................................................... 82
`XI. GROUND 1D – Claims 17, 18, and 29 Are Rendered Obvious by Aizawa in
`view of Inokawa, Mendelson-2006, and Beyer, Jr. ................................................. 82
`A. Claim 17 ......................................................................................................... 82
`B. Claim 18 ......................................................................................................... 85
`C. Claim 29 ......................................................................................................... 86
`XII. GROUND 1E – Claims 16-18 and 27-29 Are Rendered Obvious by Aizawa in
`view of Inokawa, Goldsmith, and Lo ...................................................................... 87
`A. The Aizawa-Inokawa-Goldsmith-Lo Combination ....................................... 87
`B. Claim 16 ......................................................................................................... 91
`C. Claim 17 ......................................................................................................... 91
`D. Claim 18 ......................................................................................................... 92
`E. Claim 27 ......................................................................................................... 93
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`3
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`F. Claim 28 ......................................................................................................... 93
`G. Claim 29 ......................................................................................................... 94
`XIII. GROUND 1F – Claim 10 Is Rendered Obvious by Aizawa in view of
`Inokawa, and Al-Ali ................................................................................................. 95
`A. Claim 10 ......................................................................................................... 95
`XIV. GROUND 2A – Claims 1-4, 6-15, and 19-26 Are Rendered Obvious by
`Mendelson-1988 in View of Inokawa ..................................................................... 97
`A. Claim 1 ........................................................................................................... 98
`B. Claim 2 .........................................................................................................110
`C. Claim 3 .........................................................................................................111
`D. Claim 4 .........................................................................................................113
`E. Claim 5 .........................................................................................................113
`F. Claim 6 .........................................................................................................114
`G. Claim 7 .........................................................................................................115
`H. Claim 8 .........................................................................................................116
`I. Claim 9 .........................................................................................................117
`J. Claim 11 .......................................................................................................118
`K. Claim 12 .......................................................................................................118
`L. Claim 13 .......................................................................................................119
`M. Claim 14 .......................................................................................................120
`N. Claim 15 .......................................................................................................121
`O. Claim 19 .......................................................................................................122
`P. Claim 20 .......................................................................................................125
`Q. Claim 21 .......................................................................................................125
`R. Claim 22 .......................................................................................................125
`S. Claim 23 .......................................................................................................126
`T. Claim 24 .......................................................................................................126
`U. Claim 25 .......................................................................................................126
`XV. GROUND 2B – Claims 16, 27, and 28 Are Rendered Obvious by Mendelson-
`1988 in view of Inokawa and Mendelson-2006. ....................................................128
`A. The Mendelson-1988-Inokawa-Mendelson-2006 Combination ..................128
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`4
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`B. Claim 16 .......................................................................................................129
`C. Claim 27 .......................................................................................................130
`D. Claim 28 .......................................................................................................131
`XVI. GROUND 2C – Claims 17, 18, and 29 Are Rendered Obvious by Mendelson-
`1988 in view of Inokawa, Mendelson-2006, and Beyer, Jr. ..................................131
`A. Claim 17 .......................................................................................................131
`B. Claim 18 .......................................................................................................135
`C. Claim 29 .......................................................................................................135
`XVII. CONCLUSION .........................................................................................136
`
`
`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 (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, attached as Exhibit A. Below I provide a
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`short summary of my education and experience which I believe to be most
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`pertinent to the opinions that I express here.
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`5
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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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`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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`6
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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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`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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`7
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`
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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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`8
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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 is attached as APPLE-1004 and includes a full
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`listing of all cases in which I have testified at deposition or trial in the preceding
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`four years.
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`9
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`14.
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`I have been retained on behalf of Apple Inc. to offer technical opinions
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`relating to U.S. Patent No. 10,299,708 (“the ’708 patent”) and prior art references
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`relating to its subject matter. I have reviewed the ’708 patent, relevant excerpts of
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`the prosecution history of the ’708 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. 2002/0188210 to Aizawa (“Aizawa”) (APPLE-1006)
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`English translation of JP 2006-296564 to Inokawa et al. (“Inokawa”)
`(APPLE-1007, APPLE-1008)
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`U.S. Pub. No. 2001/0056243 to Ohsaki et al. (“Ohsaki”) (APPLE-
`1014)
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`“Design and Evaluation of a New Reflectance Pulse Oximeter
`Sensor,” Y. Mendelson, et al.; Worcester Polytechnic Institute,
`Biomedical Engineering Program, Worcester, MA 01609;
`Association for the Advancement of Medical Instrumentation, vol. 22,
`No. 4, 1988; pp. 167-173 (“Mendelson-1988”) (APPLE-1015)
`
`“A Wearable Reflectance Pulse Oximeter for Remote Physio-logical
`Monitoring,” Y. Mendelson, et al.; Proceedings of the 28th IEEE
`EMBS Annual International Conference, 2006; pp. 912-915
`(“Mendelson-2006”) (APPLE-1016)
`
`U.S. Pat. No. 7,031,728 (“Beyer, Jr.”) (APPLE-1019)
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`U.S. Pub. No. 2007/0093786 to Goldsmith et al. (“Goldsmith”)
`(APPLE-1027)
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`U.S. Pub. No. 2004/0138568 to Lo et al. (“Lo”) (APPLE-1028)
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`U.S. Pub. No. 2008/0242958 to Al-Ali et al. (“Al-Ali”) (APPLE-
`1030)
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`10
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`15.
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`I have also reviewed various supporting references and other documentation
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`as further noted in my opinions below.
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`16. 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 ’708 patent at the time of the
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`earliest possible priority date of the ’708 patent, and I have done so during my
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`review of these materials. The application leading to the ’708 patent was filed on
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`January 29, 2019, and claims the benefit of priority to a provisional application
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`filed July 3, 2008. However, support for the subject matter claimed in the ’708
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`patent appears to have been first disclosed in a CIP application filed on July 2,
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`2009 (“the Critical Date”). See APPLE-1038. Counsel has informed me that the
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`Critical Date represents the earliest possible priority date to which the challenged
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`claims of ’708 patent are entitled, and I have therefore used that Critical Date in
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`my analysis below.
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`17.
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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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`18.
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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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`11
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`engineer; my experience in teaching those subjects; and my experience in working
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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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`19. My opinions, as explained below, are based on my education, experience,
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`and expertise in the fields relating to the ’708 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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`’708 patent and the prior art discussed below.
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`II. OVERVIEW OF CONCLUSIONS FORMED
`20. 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 1-9, 11, 13-15, 19-22, 24-27 are rendered obvious by Aizawa and
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`Inokawa.
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` Claims 1-9, 11, 13-15, 19-22, 24-27 are rendered obvious by Aizawa,
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`Inokawa, and Ohsaki.
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` Claims 16, 27, 28 are rendered obvious by Aizawa, Inokawa, and
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`Mendelson-2006.
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`12
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` Claims 17, 18, and 29 are rendered obvious by Aizawa, Inokawa,
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`Mendelson-2006, and Beyer, Jr.
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` Claims 16-18, 27-29 are rendered obvious by Aizawa, Inokawa, Goldsmith,
`
`and Lo.
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` Claim 10 is rendered obvious by Aizawa, Inokawa, and Al-Ali
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` Claims 1-9, 11-15, 19-26 are rendered obvious by Mendelson-1988 and
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`Inokawa.
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` Claims 16, 27, 28 are rendered obvious by Mendelson-1988, Inokawa, and
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`Mendelson-2006.
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` Claim 17, 18, 29 is rendered obvious by Mendelson-1988, Inokawa,
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`Mendelson-2006, and Beyer, Jr.
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`
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`III. LEVEL OF ORDINARY SKILL IN THE ART
`21.
`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 ’708 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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`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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`13
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`
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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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`22. 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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`23.
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`claim meaning is its usage in the context of the patent specification as understood
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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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`14
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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 Critical Date of the ’708
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`patent as the point in time for claim interpretation purposes.
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`B.
`Legal Standards for Anticipation
`I have been informed by Counsel and understand that documents and
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`24.
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`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.
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`25.
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`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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`26.
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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
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`15
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`27.
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`I have been informed by Counsel and understand that documents and
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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.
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`28.
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`I have been informed by Counsel and understand that a claim is unpatentable
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`for obviousness under 35 U.S.C. § 103 (in the pre-AIA form of that statute that
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`applies to the ’708 patent) “if the differences between the subject matter sought to
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`be patented and the prior art are such that the subject matter as a whole would have
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`been obvious at the time the invention was made to a person having ordinary skill
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`in the art to which said subject matter pertains.” I am informed by Counsel and
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`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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`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.
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`29.
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`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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`16
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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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`30.
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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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`31.
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`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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`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.”
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`32.
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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
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`understand that the prior art references themselves may provide a suggestion,
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`motivation, or reason to combine, but that the nexus linking two or more prior art
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`references is sometimes simple common sense. I have been informed by Counsel
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`and understand that obviousness analysis recognizes that market demand, rather
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`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.
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`33.
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`I have been informed by Counsel and understand that if a technique has been
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`used to improve one device, and a person of ordinary skill at the time of invention
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`would have recognized that it would improve similar devices in the same way,
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`using the technique is obvious unless its actual application is beyond his or her
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`skill.
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`34.
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`I have been informed by Counsel and understand that practical and common
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`sense considerations should guide a proper obviousness analysis, because familiar
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`items may have obvious uses beyond their primary purposes. I have been
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`informed by Counsel and understand that a person of ordinary skill looking to
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`overcome a problem will often be able to fit together the teachings of multiple
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`prior art references. I have been informed by Counsel and understand that
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`18
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`obviousness analysis therefore takes into account the inferences and creative steps
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`that a person of ordinary skill would have employed at the time of invention.
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`35.
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`I have been informed by Counsel and understand that a proper obviousness
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`analysis focuses on what was known or obvious to a person of ordinary skill at the
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`time of invention, not just the patentee. Accordingly, I understand that any need or
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`problem known in the field of endeavor at the time of invention and addressed by
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`the patent can provide a reason for combining the elements in the manner claimed.
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`36.
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`I have been informed by Counsel and understand that a claim can be obvious
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`in light of a single reference, without the need to combine r