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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DECLARATION OF DR. MAJID SARRAFZADEH
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`Apple Inc.
`APL1003
`U.S. Patent No. 8,929,965
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`FITBIT, Ex. 1003
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`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`I.
`II. Qualifications ................................................................................................... 2
`III. Legal Principles ............................................................................................... 5
`IV. State of the Art ...............................................................................................10
`IV. The ’965 Patent ..............................................................................................18
`A. Overview ..................................................................................................18
`B. Summary of the prosecution history ........................................................21
`C. Level of ordinary skill in the art ...............................................................22
`D. Claim construction ....................................................................................23
`V. Ground 1: Claims 1, 2, and 12 are unpatentable under Pre-AIA 35 U.S.C. §
`103(a) as being obvious over Numaga. .........................................................26
`A. Overview of Numaga ...............................................................................26
`B. Numaga renders obvious each and every element of the sensor module of
`claim 1 ......................................................................................................28
`[1.P] A sensor module for detecting and/or measuring physiological
`information from a subject ..................................................................28
`[1.1] a housing ..........................................................................................28
`[1.2] at least one optical emitter supported by the housing ......................29
`[1.3] at least one optical detector supported by the housing ....................30
`[1.4] a first light guide supported by the housing ....................................30
`[1.5] wherein the first light guide is in optical communication with the at
`least one optical emitter .......................................................................31
`[1.6] wherein the first light guide comprises a distal end having an
`exposed end surface that is configured to engage a portion of a body
`of the subject .......................................................................................33
`[1.7] wherein the first light guide is configured to deliver light from the at
`least one optical emitter directly into the body of the subject via the
`exposed end surface thereof ................................................................33
`[1.8] a second light guide supported by the housing ................................34
`[1.9] wherein the second light guide is in optical communication with the
`at least one optical detector .................................................................34
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`FITBIT, Ex. 1003
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`[1.10] wherein the second light guide comprises a distal end having an
`exposed end surface that is configured to engage a portion of the body
`of the subject .......................................................................................36
`[1.11] wherein the second light guide is configured to collect light
`directly from the body of the subject via the exposed end surface
`thereof and deliver collected light to the at least one optical detector 37
`C. Claim 2 .....................................................................................................37
`D. Claim 12 ...................................................................................................38
`VI. Ground 2: Claims 3 and 4 are unpatentable under Pre-AIA 35 U.S.C.
`§ 103(a) over Numaga in view of Vetter. ......................................................38
`A. Overview of Vetter ...................................................................................39
`B. Rationale to combine the teachings of Numaga and Vetter .....................43
`VII. Ground 3: Claim 5 is unpatentable under Pre-AIA 35 U.S.C. § 103(a) over
`Numaga in view of Vetter and in further view of Dekker .............................44
`A. Overview of Dekker .................................................................................44
`B. Rationale to combine the teachings of Numaga, Vetter, and Dekker ......46
`VIII. Ground 4: Claims 6 and 7 are unpatentable under Pre-AIA 35 U.S.C. §
`103(a) over Numaga in view of Debreczeny. ................................................48
`A. Overview of Debreczeny ..........................................................................49
`B. Rationale to combine the teachings of Numaga and Debreczeny ............50
`IX. Ground 5: Claims 8 and 9 are unpatentable under Pre-AIA 35 U.S.C. §
`103(a) over Numaga in view of Rafert. .........................................................51
`A. Overview of Rafert ...................................................................................52
`B. Rationale to combine the teachings of Numaga and Rafert .....................53
`X. Ground 6: Claim 10 is unpatentable under Pre-AIA 35 U.S.C. § 103(a) over
`Numaga in view of Negley. ...........................................................................54
`A. Overview of Negley .................................................................................55
`B. Rationale to combine the teachings of Numaga and Negley ...................56
`XI. Ground 7: Claim 11 is unpatentable under Pre-AIA 35 U.S.C. § 103(a) over
`Numaga in view of Miao. ..............................................................................57
`A. Overview of Miao .....................................................................................57
`B. Rationale to combine the teachings of Numaga and Miao ......................58
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`FITBIT, Ex. 1003
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`XII. Ground 8: Claims 1 and 8-12 are unpatentable under Pre-AIA 35 U.S.C. §
`102(b) as being anticipated by Fraden ...........................................................59
`A. Overview of Fraden ..................................................................................59
`1. First Embodiment ................................................................................59
`2. Second Embodiment............................................................................61
`B. Fraden anticipates claim 1. .......................................................................64
`[1.P] A sensor module for detecting and/or measuring physiological
`information from a subject ..................................................................64
`[1.1] a housing ..........................................................................................64
`[1.2] at least one optical emitter supported by the housing ......................65
`[1.3] at least one optical detector supported by the housing ....................65
`[1.4] a first light guide supported by the housing ....................................66
`[1.5] wherein the first light guide is in optical communication with the at
`least one optical emitter .......................................................................66
`[1.6] wherein the first light guide comprises a distal end having an
`exposed end surface that is configured to engage a portion of a body
`of the subject .......................................................................................67
`[1.7] wherein the first light guide is configured to deliver light from the at
`least one optical emitter directly into the body of the subject via the
`exposed end surface thereof ................................................................68
`[1.8] a second light guide supported by the housing ................................69
`[1.9] wherein the second light guide is in optical communication with the
`at least one optical detector .................................................................69
`[1.10] wherein the second light guide comprises a distal end having an
`exposed end surface that is configured to engage a portion of the body
`of the subject .......................................................................................70
`[1.11] wherein the second light guide is configured to collect light
`directly from the body of the subject via the exposed end surface
`thereof and deliver collected light to the at least one optical detector 71
`C. Claim 8 .....................................................................................................71
`D. Claim 9 .....................................................................................................73
`E. Claim 10 ...................................................................................................73
`F. Claim 11 ...................................................................................................74
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`G. Claim 12 ...................................................................................................74
`XIII. Ground 9: Claims 2-4 are Unpatentable Under Pre-AIA 35 U.S.C. § 103(a)
`Over Fraden in View of Verjus. ....................................................................75
`A. Overview of Verjus ..................................................................................75
`B. Rationale to combine the teachings of Fraden and Verjus .......................77
`XIV. Ground 10: Claim 5 is unpatentable under Pre-AIA 35 U.S.C. § 103(a) over
`Fraden in view of Verjus and in further view of Fricke. ...............................79
`A. Overview of Fricke ...................................................................................80
`B. Rationale to combine the teachings of Fraden, Verjus, and Fricke .........82
`XV. Ground 11: Claims 6 and 7 are unpatentable under Pre-AIA 35 U.S.C. §
`103(a) over Fraden in view of Debreczeny. ..................................................83
`A. Overview of Debreczeny ..........................................................................84
`B. Rationale to combine the teachings of Fraden and Debreczeny ..............84
`XVI. Conclusion .....................................................................................................86
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`FITBIT, Ex. 1003
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`Exhibit
`No.
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`EXHIBIT LIST
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`Description
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`1001
`1002
`1004
`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
`1013
`1014
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`1015
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`1016
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`1018
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`1019
`1020
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`1021
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`1022
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`1023
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`to
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`U.S. Patent No. 8,929,965 to LeBoeuf et al., issued January 6, 2015
`U.S. Patent No. 8,929,965 File History
`Curriculum Vitae of Dr. Majid Sarrafzadeh
`U.S. Patent Application Publication No. 2005/0209516 to Fraden,
`published September 22, 2005
`U.S. Patent Application Publication No. 2003/0233051 to Verjus et
`al., published December 18, 2003
`U.S. Patent Application Publication No. 2008/0081972
`Debreczeny, published April 3, 2008
`Japanese Patent Application Publication No. 2005/040261 A to
`Numaga et al., published February 17, 2005
`Certified English-language translation of Japanese Patent Application
`Publication No. 2005/040261 A to Numaga et al., published
`February 17, 2005
`U.S. Patent Application Publication No. 2003/0065269 to Vetter et
`al., published April 3, 2003
`U.S. Patent No. 6,702,752 to Dekker, issued March 9, 2004
`U.S. Patent No. 5,817,008 to Rafert et al., issued October 6, 2008
`U.S. Patent Application Publication No. 2005/0212405 to Negley,
`published September 29, 2005
`International Patent Application Publication No. 2005/036212 to
`Miao et al., published April 21, 2005
`U.S. Patent Application Publication No. 2009/0105556 to Fricke et
`al., published April 23, 2009
`U.S. Patent No. 3,704,706 to Herczfeld et al., issued December 5,
`1972
`U.S. Patent No. 5,297,548 to Pologe, issued March 29, 1994
`Med. Sci. Series, Int’l Fed’n for Med. and Biological Eng’g and the
`Int’l Org. for Med. Physics, Design of Pulse Oximeters (J.G. Webster
`ed., Inst. of Physics Publ’g 1997)
`John Allen, Photoplethysmography and its application in clinical
`physiological measurement, Physiological Measurement 28 (2007)
`U.S. Patent Application Publication No. 2008/0132798 to Hong,
`published June 5, 2008
`U.S. Patent Application Publication No. 2008/0177162 to Bae,
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`FITBIT, Ex. 1003
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`Exhibit
`No.
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`1024
`1025
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`1026
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`Description
`
`published July 24, 2008
`U.S. Patent No. 5,807,267 to Bryars et al. issued September 15, 1998
`Hyonyoung Han et al., Development of a wearable health monitoring
`device with motion artifact reduced algorithm, International
`Conference on Control, Automation and Systems, IEEE (2007)
`Excerpt from Merriam Webster’s Collegiate Dictionary,
`Eleventh Edition, 2008; p. 603
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`FITBIT, Ex. 1003
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`I.
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`Introduction
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`I, Dr. Majid Sarrafzadeh, declare as follows:
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`1.
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`I am currently a distinguished professor of computer science at the
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`University of California at Los Angeles (“UCLA”), director of the UCLA
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`Embedded and Reconfigurable Computing Laboratory (“ER Lab”), and a co-
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`director of the UCLA Center for SMART Health. I have been actively engaged in
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`research of Wearable Systems for 16 years and Embedded Systems, Design and
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`Analysis of Algorithms, and Health Analytics for about 29 years.
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`2.
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`I have been retained on behalf of Apple Inc. to provide expert
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`opinions in connection with a petition for inter partes review before the United
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`States Patent and Trademark Office. I understand that this declaration involves my
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`expert opinions and expert knowledge related to U.S. Patent No. 8,929,965 (“the
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`’965 Patent”), titled “Light-Guiding Devices and Monitoring Devices
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`Incorporating Same,” and its field of endeavor.
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`3.
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`In preparing this declaration, I have reviewed and am familiar with the
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`’965 Patent and its file history. The ’965 Patent describes “a sensor module for
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`detecting and/or measuring physiological information from a subject.” (Ex. 1001,
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`’965 Patent, Abstract.) I am familiar with the technology described in the ’965
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`Patent as of its May 9, 2014 filing date, as well as the state of the art as of its
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`claimed February 25, 2009 priority date.
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`4.
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`I have reviewed and am familiar with each exhibit cited herein. I
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`confirm that to the best of my knowledge the accompanying exhibits are true and
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`accurate copies of what they purport to be, and that an expert in the field would
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`reasonably rely on them to formulate opinions such as those set forth in this
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`declaration.
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`5.
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`I have been asked to provide my independent technical review,
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`analysis, insights, and opinions regarding the ’965 Patent and the references that
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`form the basis for the eleven grounds of unpatentability set forth in the Petition for
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`Inter Partes Review of the ’965 Patent.
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`II. Qualifications
`As indicated in my curriculum vitae (filed as Ex. 1004), I am
`6.
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`currently a professor of computer science at UCLA and have been in that position
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`for the last sixteen years. I am also the director of the UCLA Embedded and
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`Reconfigurable Computing Laboratory (“ER Lab”), a co-director of the UCLA
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`Center for SMART Health, a co-director of the BRITE Center on Minority Health
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`Disparities, and a co-founder of UCLA Wireless Health Institute.
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`7.
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`I earned a Bachelor of Science, Master of Science, and Ph.D. degrees
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`from the University of Illinois at Urbana-Champaign in Electrical and Computer
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`Engineering in 1982, 1984, and 1987, respectively.
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`8.
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`I became an Assistant Professor of Electrical and Computer
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`Engineering at Northwestern University in 1987, earned tenure in 1993, and
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`became a Full Professor in 1997.
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`9.
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`In 2000, I joined the Computer Science Department at UCLA as a
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`Full Professor. In 2008, I co-founded and became a director of the UCLA Wireless
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`Health Institute. I currently teach two core undergraduate courses (involving
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`implementing digital logic designs and advanced digital design techniques), a
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`course on Algorithms and Complexity, and a series of graduate courses in the area
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`of embedded systems and Wireless Health.
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`10.
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`I have experience as a system designer, circuit designer, and software
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`designer. This experience includes positions as a design engineer at IBM and
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`Motorola and a test engineer at Central Data Corporation. I was the main architect
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`of an Electronic Design Automation (“EDA”) software tool for Monterey Design
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`Systems, Inc. (“Monterey”). I co-founded and managed the technical team at
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`Hierarchical Design, Inc. (“Hier Design”), an EDA company that specialized in
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`reconfigurable Field-Programmable Gate Array (FPGA) systems. Hier Design was
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`acquired by Xilinx in 2004. I have cofounded MediSens Wireless, Bruin
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`Biometrics, and WANDA Health.
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`11.
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`I am a Fellow of the Institute of Electrical and Electronics Engineers,
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`Inc. (“IEEE”) for my contributions to “Theory and Practice of VLSI Design.” I
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`have served on the technical program committees of numerous conferences in the
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`area of system design. I cofounded the International conference on Wireless Health
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`and have served in various committees of this conference.
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`12.
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`I have published approximately 500 papers, and have received a
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`number of best paper and distinguished paper awards. I am a co-author of the book
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`“Synthesis Techniques and Optimizations for Reconfigurable Systems” (2003 by
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`Springer) and a co-author of the papers such as:
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`• Adaptive Electrocardiogram Feature Extraction on Distributed
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`Embedded Systems, IEEE Transactions on Parallel and Distributed
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`Systems special issue on High Performance Computational Biology
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`(2006);
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`• A Remote Patient Monitoring System for Congestive Heart Failure,
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`Journal of Medical Systems (2011);
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`• SmartFall: An Automatic Fall Detection and Cause Identification
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`System, IEEE Sensors Journal (2013); and
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`• Designing a Robust Activity Recognition Framework for Health and
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`Exergaming using Wearable Sensors, IEEE Journal of Biomedical
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`and Health Informatics (2013).
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`13. A more detailed account of my work experience and qualifications,
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`including a list of all publications authored in the previous 10 years, can be found
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`in my Curriculum Vitae, which is identified as Ex. 1004.
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`14.
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`I am being compensated at my rate of $650 per hour for my work on
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`this case. My compensation is not dependent upon my opinions or testimony or the
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`outcome of this case.
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`III. Legal Principles
`I understand that my analysis requires an understanding of the scope
`15.
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`of the ’965 Patent claims. I understand that the disclosures of the ’965 Patent and
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`the prior art are judged from the perspective of a person of ordinary skill in the art
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`at the time of the purported invention. For the purposes of this declaration, I have
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`been instructed to consider the time of the purported invention of the ’965 Patent to
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`be February 25, 2009 for each challenged claim unless noted otherwise. I will note,
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`however, that my opinions would not change even if all the relevant disclosures
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`were judged from a later time period.
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`16.
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`I understand that terms of the ’965 Patent claims are, by rule, given
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`the broadest reasonable construction in light of its specification. Unless otherwise
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`noted, I have generally given the claim terms their plain and ordinary meaning as
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`understood by a person of ordinary skill in the art at the time of purported
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`invention.
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`17.
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`I understand that a claim is invalid if it is anticipated or obvious. My
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`opinions here relate to both anticipation and obviousness as detailed below.
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`18.
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`I understand that anticipation of a claim requires that every element of
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`a claim is expressly or inherently disclosed in a single prior art reference. I
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`understand that an anticipating reference need not use the exact terms of the
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`claims, but must describe the patented subject matter with sufficient clarity and
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`detail to establish that the claimed subject matter existed in the prior art and that
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`such existence would be recognized by persons of ordinary skill in the field of the
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`purported invention. I also understand that an anticipating reference must enable
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`one of ordinary skill in the art to reduce the purported invention to practice without
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`undue experimentation.
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`19.
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`I understand that an obviousness analysis involves comparing a claim
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`to the prior art to determine whether the claimed invention would have been
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`obvious to a person of ordinary skill in the art at the time of the invention in view
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`of the prior art and in light of the general knowledge in the art as a whole. I also
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`understand that obviousness is ultimately a legal conclusion based on underlying
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`facts of four general types, all of which must be considered: (1) the scope and
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`content of the prior art; (2) the level of ordinary skill in the art; (3) the differences
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`between the claimed invention and the prior art; and (4) any objective indicia of
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`nonobviousness.
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`20.
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`I also understand that obviousness may be established by combining
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`or modifying the teachings of the prior art. Specific teachings, suggestions, or
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`motivations to combine any first prior art reference with a second prior art
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`reference can be explicit or implicit, but must have existed before the date of
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`invention. I understand that prior art references themselves may be one source of a
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`specific teaching or suggestion to combine features of the prior art, but that such
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`suggestions or motivations to combine art may come from the knowledge of a
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`person of ordinary skill in the art. Specifically, a rationale to combine the teachings
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`of references may include logic or common sense available to a person of ordinary
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`skill in the art.
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`21.
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`I understand that a reference may be relied upon for all that it teaches,
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`including uses beyond its primary purpose. I understand that though a reference
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`may be said to teach away when a person of ordinary skill, upon reading the
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`reference, would be discouraged from following the path set out in the reference,
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`the mere disclosure of alternative designs does not teach away.
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`22.
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`I further understand that whether there is a reasonable expectation of
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`success from combining references in a particular way is also relevant to the
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`analysis. I understand there may be a number of rationales that may support a
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`conclusion of obviousness, including:
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`• Combining prior art elements according to known methods to yield
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`predictable results;
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`• Substitution of one known element for another to obtain predictable
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`results;
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`• Use of known technique to improve similar devices (methods, or
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`products) in the same way;
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`• Applying a known technique to a known device (method, or product)
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`ready for improvement to yield predictable results;
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`• “Obvious to try” – choosing from a finite number of identified,
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`predictable solutions, with a reasonable expectation of success;
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`• Known work in one field of endeavor may prompt variations of it for use
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`in either the same field or a different one based on design incentives or
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`other market forces if the variations are predictable to one of ordinary
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`skill in the art; or
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`• Some teaching, suggestion, or motivation in the prior art that would have
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`led one of ordinary skill to modify the prior art reference or to combine
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`prior art teachings to arrive at the claimed invention.
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`23.
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`I understand that it is not proper to use hindsight to combine
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`references or elements of references to reconstruct the invention using the claims
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`as a guide. My analysis of the prior art is made from the perspective of person of
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`ordinary skill in the art at the time of the purported invention.
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`24.
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`I understand that so-called objective considerations may be relevant to
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`the determination of whether a claim is obvious should the Patent Owner allege
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`such evidence. Such objective considerations can include evidence of commercial
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`success caused by an invention, evidence of a long-felt need that was solved by an
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`invention, evidence that others copied an invention, or evidence that an invention
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`achieved a surprising result. I understand that such evidence must have a nexus, or
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`causal relationship to the elements of a claim, in order to be relevant to the
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`obviousness or non-obviousness of the claim. I am unaware of any such objective
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`considerations having a nexus to the claims at issue in this proceeding.
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`25.
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`I understand that for a reference to be used to show that a claim is
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`obvious, the reference must be analogous art to the claimed invention. I understand
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`that a reference is analogous to the claimed invention if the reference is from the
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`same field of endeavor as the claimed invention, even if it addresses a different
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`problem, or if the reference is reasonably pertinent to the problem faced by the
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`inventor, even if it is not in the same field of endeavor as the claimed invention. I
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`understand that a reference is reasonably pertinent based on the problem faced by
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`the inventor as reflected in the specification, either explicitly or implicitly.
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`IV. State of the Art
`In the 40 years prior to the ’965 Patent, artisans had developed and
`26.
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`continued to improve sensor modules for optically detecting and measuring
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`physiological information, such as heart rate and respiration rate. For example, a
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`1972 patent illustrates many of the conventional components of a heart rate
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`monitor using an optical technique to continuously measure the pulse of a subject.
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`Ex. 1018. As shown below, the small probe housing included a light source to emit
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`light directly into the finger of a subject and a photodetector to collect light directly
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`from the finger. Ex. 1018, 2:60-3:22, Fig. 1.
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`
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`
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`Light source
`Housing
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`Incident
`light
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`Photodetector
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`Reflected
`light
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`
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`Ex. 1018, fig. 1 (annotation added).
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`27.
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`In operation, the probe was placed upon the patient’s finger such that
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`blood flowing in the finger’s capillaries reflected incident red light. Ex. 1018, 3:40-
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`42, Fig. 1; Ex. 1020, pp. 34-36. The intensity of the reflected light was understood
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`FITBIT, Ex. 1003
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`to be inversely proportional to the amount of blood flowing in the finger. Ex. 1018,
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`3:42-55; Ex. 1020, pp. 40-49. For each heartbeat, blood is pumped into and out of
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`the capillaries, thereby causing a periodic decrease and increase in the reflected
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`light intensity. Ex. 1018, 3:42-55; Ex. 1020, pp. 40-49. The detected periodic
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`waveform was known to represent a volume of the circulating blood synchronized
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`to each heartbeat. Ex. 1018, 3:42-55; Ex. 1020, pp. 40-49. This pulsatile waveform
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`was known as a photoplethysmographic pulse wave. Ex. 1020, pp. 13-18, 40-49;
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`Ex. 1021, § 2.1.
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`
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`Ex. 1020, p. 47.
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`28. Hence, photoplethysmography (PPG) is a known optical measurement
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`technique used to detect blood volume changes in living tissue due to arterial
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`pulsation. Ex. 1021, § 1; Ex. 1020, pp. 240-241. The basic form of PPG technology
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`requires only a few opto-electronic components: a light source (often red or near
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`infrared) to illuminate the tissue (commonly at the ear, wrist, or finger) and a
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`photodetector to measure the small variations in light intensity associated with
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`changes in blood volume. Ex. 1021, §§ 1, 2.4; Ex. 1020, pp. 34-38. A simple,
`
`appropriately programmed signal processor can extract heart rate and a variety of
`
`other physiological parameters. Ex. 1021, § 3.
`
`29. Photoplethysmography has had widespread clinical application, with
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`the technology utilized in commercially available medical devices, such as pulse
`
`oximeters. Ex. 1021, § 1. A major advance in the clinical use of PPG-based
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`technology came with the introduction of the pulse oximeter as a non-invasive
`
`method for monitoring patients’ arterial oxygen saturation. Ex. 1021, § 2.3; Ex.
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`1020, preface. Oxygen saturation of the hemoglobin in arterial blood is determined
`
`by the relative proportions of oxygenated hemoglobin and reduced hemoglobin in
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`the arterial blood. Ex. 1019, 1:20-56; Ex. 1020, pp. 34-38. A pulse oximeter uses
`
`PPG signals to determine the oxygen saturation of the hemoglobin by measuring
`
`the difference in the light absorption of these two forms of hemoglobin. Ex. 1019,
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`1:20-56; Ex. 1020, pp. 34-38. Reduced or deoxygenated hemoglobin absorbs more
`
`light in the red band (600-800 nm) than does oxyhemoglobin, while
`
`oxyhemoglobin absorbs more light in the near infrared band (800-1000 nm) than
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`does reduced hemoglobin. Ex. 1019 , 1:20-56; Ex. 1020, pp. 34-38, 86-88. Oxygen
`
`
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`saturation is then estimated based on the ratio between the detected intensity of red
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`and infrared light. Ex. 1019, 1:20-56; Ex. 1020, pp. 34-38.
`
`30. The pulse oximeter typically includes a probe which contains two
`
`light emitting diodes (LEDs), one red and one infrared, and is placed in contact
`
`with the skin. Ex. 1019, 1:20-56; Ex. 1020, pp. 34-38. There were conventionally
`
`two types of probes for pulse oximetry: reflectance and transmittance. Ex. 1020,
`
`pp. 86-89.
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`Transmittance Probe
`
`Reflectance Probe
`
`
`
`
`
`
`
`Ex. 1020, pp. 87-88, Figures 7.1, 7.2.
`
`31. By the late 1990’s, pulse oximetry was recognized worldwide as a
`
`standard of care in anesthesiology and in widespread use in medical facilities. Ex.
`
`1020, preface. The model 9500 pulse oximeter from Nonin Medical, Inc., shown in
`
`the figure below, was a small sensor commercially available more than a decade
`
`before the effective filing date of the ’965 Patent. Ex. 1020 , p. 207, fig. 12.5. With
`
`
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`FITBIT, Ex. 1003
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`light weight and an extremely small size, it displays heart rate and oxygen
`
`saturation (SpO2).
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`
`
`Ex. 1020, p. 207, fig.12.5.
`
`32.
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`In recent decades, the desire for small, reliable, low-cost and simple-
`
`to-use noninvasive (cardiovascular) assessment techniques were key factors that
`
`have propelled the use of photoplethysmography. Ex. 1021, § 2.3. Advances in
`
`opto-electronics and clinical instrumentation have also significantly contributed to
`
`its advancement. Ex. 1021, § 2.3. The developments in semiconductor technology,
`
`light emitting diodes (LEDs), photodiodes, and phototransistors have made
`
`considerable improvements in the size, sensitivity, reliability and reproducibility of
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`
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`FITBIT, Ex. 1003
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`

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`PPG probe design. Ex. 1021, § 2.3. There have also been considerable
`
`developments in computer-based digital signal processing and pulse-wave analysis.
`
`Ex. 1021, § 2.3.
`
`33. As this technology became ever smaller and more robust, PPG sensors
`
`were integrated into wearable technology such as wristwatches, earphones,
`
`headsets, etc. See, e.g., Ex. 1022, figs. 1-2, ¶¶ 0024-0028 (integrating with
`
`headset); Ex. 1023, figs. 2, (reproduced below); Ex. 1024, figs. 1, 6, 7.
`
`Headset
`
`Earbuds
`
`
`
`Ex. 1023, Fig. 2,
`
`PPG sensor
`
`
`
`
`
`34. Because these instruments use optical means to make their
`
`measurements, it was recognized that such optical sensors were susceptible to
`
`noise from ambient light. Ex. 1020, pp. 19, 184-185. Optical interference occurs
`
`when bright light from an external source (e.g., ambient light) reaches the
`
`photodiode, or when light reaches the photodiode without passing through a
`
`pulsatile arteriolar bed. Ex. 1020, pp. 19, 184-185. Consequently, to obtain
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`FITBIT, Ex. 1003
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`accurate measurements, potential sources of optical interference must be
`
`controlled. Ex. 1020, pp. 19, 184-185. Because the optical components are located
`
`in the probe, proper probe configuration and use are key factors in reducing optical
`
`interference. Ex. 1020, pp. 19, 184-185. The figure below illustrates ambient light
`
`interference and optical shunt in conventional pulse oximetry. Ex. 1020, p. 185,
`
`fig. 11.3. Optical shunting occurs when the light from the LEDs reaches the
`
`photodiode without passing through arterial blood. Ex. 1020, p. 185, fig. 11.3.
`
`
`
`Ex. 1020, fig. 11.3. Accordingly, well prior