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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. 8,942,776
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`

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`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
`
`TABLE OF CONTENTS
`
`V.
`
`Introduction ...................................................................................................... 1
`I.
`II. Qualifications ................................................................................................... 2
`III. Legal Principles ............................................................................................... 5
`IV. State of the Art ............................................................................................... 10
`A. Wearable Technology ............................................................................... 16
`B. Optical Noise ............................................................................................ 18
`1. Optical interference ............................................................................. 20
`2. Packaging ............................................................................................ 23
`C. Motion Artifacts ....................................................................................... 25
`D. Signal Processing Techniques .................................................................. 27
`The ’776 Patent .............................................................................................. 29
`A. Overview .................................................................................................. 29
`B. Summary of the prosecution history ........................................................ 31
`C. Level of ordinary skill in the art ............................................................... 35
`D. Claim construction .................................................................................... 36
`1. “monitoring” ........................................................................................ 37
`2. “free end surface” ................................................................................ 37
`3. “directly into the body” and “directly from the body” ........................ 38
`4. “engage” .............................................................................................. 39
`VI. Ground 1: Claim 1 is unpatentable under Pre-AIA 35 U.S.C. § 103(a) as
`being obvious over Numaga. ......................................................................... 40
`A. Overview of Numaga ............................................................................... 40
`B. Claim 1 ..................................................................................................... 42
`[1.P.1] A method of monitoring a subject via a sensor module ............... 42
`[1.P.2] wherein the sensor module includes at least one optical emitter
`and at least one optical detector .......................................................... 43
`[1.P.3] a first light guide having a proximal end optically coupled to the
`at least one optical emitter and an opposite distal end with a free end
`surface.................................................................................................. 44
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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`[1.P.4] a second light guide having a proximal end optically coupled to
`the at least one optical detector and an opposite distal end with a free
`end surface ........................................................................................... 46
`[1.1] attaching the sensor module to a body of the subject such that the
`respective distal end free end surfaces of the first and second light
`guides engage respective portions of the body of the subject ............. 48
`[1.2] delivering light from the at least one optical emitter directly into the
`body of the subject via the distal end free end surface of the first light
`guide .................................................................................................... 51
`[1.3] collecting light directly from the body of the subject via the distal
`end free end surface of the second light guide .................................... 52
`VII. Ground 2: Claims 2-4 and 8 are unpatentable under Pre-AIA 35 U.S.C.
`§ 103(a) over Numaga in view of Vetter. ...................................................... 53
`A. Overview of Vetter ................................................................................... 54
`B. Claim 2 ..................................................................................................... 57
`C. Claim 3 ..................................................................................................... 61
`D. Claim 4 ..................................................................................................... 64
`E. Claim 8 ..................................................................................................... 66
`VIII. 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 ............................. 68
`A. Overview of Dekker ................................................................................. 69
`B. Claim 5 ..................................................................................................... 71
`IX. Ground 4: Claim 1 is unpatentable under Pre-AIA 35 U.S.C. § 102(b) as
`being anticipated by Fraden. .......................................................................... 75
`A. Overview of Fraden .................................................................................. 75
`B. Fraden anticipates claim 1. ....................................................................... 78
`[1.P.1] A method of monitoring a subject via a sensor module ............... 78
`[1.P.2] wherein the sensor module includes at least one optical emitter
`and at least one optical detector .......................................................... 78
`[1.P.3] a first light guide having a proximal end optically coupled to the
`at least one optical emitter and an opposite distal end with a free end
`surface.................................................................................................. 79
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`In Support of Inter Partes Review
`
` of U.S. Patent No. 8,942,776
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`[1.P.4] a second light guide having a proximal end optically coupled to
`the at least one optical detector and an opposite distal end with a free
`end surface ........................................................................................... 80
`[1.1] attaching the sensor module to a body of the subject such that the
`respective distal end free end surfaces of the first and second light
`guides engage respective portions of the body of the subject ............. 81
`[1.2] delivering light from the at least one optical emitter directly into the
`body of the subject via the distal end free end surface of the first light
`guide .................................................................................................... 83
`[1.3] collecting light directly from the body of the subject via the distal
`end free end surface of the second light guide .................................... 84
`X. Ground 5: Claims 2-5 and 8 are unpatentable under Pre-AIA 35 U.S.C. §
`103(a) over Fraden in view of Fricke. ........................................................... 85
`A. Overview of Fricke ................................................................................... 86
`B. Claim 2 ..................................................................................................... 88
`C. Claim 3 ..................................................................................................... 91
`D. Claim 4 ..................................................................................................... 94
`E. Claim 5 ..................................................................................................... 95
`F. Claim 8 ..................................................................................................... 99
`XVI. Conclusion ...................................................................................................101
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`Exhibit No. Description
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`
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`EXHIBIT LIST
`
`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
`
`1001
`
`U.S. Patent No. 8,942,776 to LeBoeuf et al., issued January 27,
`2015
`
`1002
`
`U.S. Patent No. 8,942,776 File History
`
`1003
`
`Declaration of Dr. Majid Sarrafzadeh
`
`1004
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`Curriculum Vitae of Dr. Majid Sarrafzadeh
`
`1005
`
`Intentionally Left Blank
`
`1006
`
`U.S. Patent No. 6,608,562 to Kimura et al., issued August 19, 2003
`
`1007-1011
`
`Intentionally Left Blank
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`John Allen, “Photoplethysmography and its application in clinical
`physiological measurement,” Physiological Measurement 28
`(2007); pp. R1-R39
`U.S. Patent Application Publication No. 2004/0059236 to
`Margulies et al., published March 25, 2004
`
`U.S. Patent Application Publication No. 2007/0016086 to Inukai et
`al., published January 18, 2007
`
`U.S. Patent Application Publication No. 2003/0236647 to Yoon et
`al., published December 25, 2003
`
`U.S. Patent No. 3,704,706 to Herczfeld et al., issued December 5,
`1972
`
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`- iv -
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`Exhibit No. Description
`
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`
`
`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
`
`1017
`
`1018
`
`1019
`
`J.G. Webster, Design of Pulse Oximeters, Institute of Physics
`Publishing (1997)
`
`International Patent Application Publication No. 2007/013054 to
`Schwartz, published February 1, 2007
`
`U.S. Patent Application Publication No. 2004/0186387 to Kosuda
`et al., published September 23, 2004
`
`1020
`
`U.S. Patent No. 5,297,548 to Pologe, issued March 29, 1994
`
`1021
`
`U.S. Patent No. 5,575,284 to Athan et al., issued November 19,
`1996
`
`1022
`
`U.S. Patent No. 5,503,016 to Koen, issued April 2, 1996
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`U.S. Patent Application Publication No. 2008/0154098 to Morris et
`al., published June 26, 2008
`
`U.S. Patent Application Publication No. 2008/0132798 to Hong et
`al., published June 5, 2008
`
`U.S. Patent Application Publication No. 2008/0177162 to Bae et
`al., published July 24, 2008
`
`U.S. Patent No. 5,807,267 to Bryars et al., issued September 15,
`1998
`
`U.S. Patent Application Publication No. 2004/0054291 to Schulz et
`al., published March 18, 2004
`
`U.S. Patent Application Publication No. 2005/0209516 to Fraden,
`published September 22, 2005
`
`1029
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`U.S. Patent No. 5,906,582 to Kondo et al., issued May 25, 1999
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`Exhibit No. Description
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`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
`
`1030
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`1031
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`1032
`
`1033
`
`1034
`
`1035
`
`U.S. Patent Application Publication No. 2008/0081972 to
`Debreczeny, published April 3, 2008
`
`U.S. Patent Application Publication No. 2006/0084879 to Nazarian
`et al., published April 20, 2006
`
`U.S. Patent Application Publication No. 2003/0065269 to Vetter et
`al., published April 3, 2003
`
`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); pp. 1581-1584
`U.S. Patent No. 5,243,992 to Eckerle et al., issued September 14,
`1993
`
`U.S. Patent Application Publication No. 2009/0105556 to Fricke et
`al., published April 23, 2009
`
`1036
`
`U.S. Patent No. 4,955,379 to Hall, issued September 11, 1990
`
`1037
`
`International Patent Application Publication No. WO 2007/122375
`to Crowe et al., published November 1, 2007
`
`1038-1149
`
`Intentionally Left Blank
`
`1150
`
`U.S. Patent No. 7,209,775 to Bae et al., issued April 24, 2007
`
`1151
`
`1152
`
`Japanese Patent Application Publication No. 2005040261, to
`Numaga, published February 17, 2005
`
`English-language translation of Japanese Patent Application
`Publication No. 2005040261 to Numaga, published February 17,
`2005
`
`
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`Exhibit No. Description
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`
`
`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
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`1153
`
`U.S. Patent No. 7,107,088 to Aceti, issued September 12, 2006
`
`1154-1175
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`Intentionally Left Blank
`
`1176
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`U.S. Patent No. 6,702,752 to Dekker, issued March 9, 2004
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`I.
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`Introduction
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`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
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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 17 years and Embedded Systems, Design and
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`Analysis of Algorithms, and Health Analytics for about 30 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. 8,942,776 (“the
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`’776 Patent”), titled “Physiological Monitoring Methods,” and its field of
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`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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`’776 Patent and its file history. The ’776 Patent describes “[a] method of
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`monitoring a subject.” ’776 Patent, Ex. 1001, Abstract. I am familiar with the
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`technology described in the ’776 Patent as of its June 6, 2014 filing date, as well as
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`the state of the art as of its claimed February 25, 2009 priority date.
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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`I have reviewed and am familiar with each exhibit cited herein. I
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`4.
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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 ’776 Patent and the references that
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`form the basis for the five grounds of unpatentability set forth in the Petition for
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`Inter Partes Review of the ’776 Patent.
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`II. Qualifications
`6.
`As indicated in my curriculum vitae (filed as Ex. 1004), I am
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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 seventeen 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 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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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`I became an Assistant Professor of Electrical and Computer
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`8.
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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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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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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 540 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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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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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
`15.
`I understand that my analysis requires an understanding of the scope
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`of the ’776 Patent claims. I understand that the disclosures of the ’776 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 ’776 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 ’776 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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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`I understand that a claim is invalid if it is anticipated or obvious. My
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`17.
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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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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`I also understand that obviousness may be established by combining
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`20.
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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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`In Support of Inter Partes Review
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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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`In Support of Inter Partes Review
`
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` of U.S. Patent No. 8,942,776
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`as a guide. My analysis of the prior art is made from the perspective of a 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
`26. Modern-day physiological monitoring included a vast array of well-
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`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
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`established devices and techniques. One well-known set of techniques involved
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`sending optical radiation into a surface of the body and measuring how the body
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`modifies that input radiation. Unsurprisingly, the apparatus used to obtain such a
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`measurement typically included an optical emitter and an optical detector. A
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`common application was for the measurement of heart rate or other vital signs of
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`an individual. One such prevailing application, known as photoplethysmography,
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`had long been in use in hospitals and clinical settings, and in the decades prior to
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`the alleged priority date of the ’776 Patent had increasingly been combined with
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`everyday wearable technology, such as wristwatches and headphones.
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`27. Photoplethysmography (hereinafter also referred to as ‘PPG’) 1 refers
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`to the use of light to measure the changes in blood volume in the tissue of a living
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`body. Allen, Ex. 1012, § 1. The technique was introduced in 1937 and had become
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`a ubiquitous part of physiological monitoring long before the ʼ776 Patent was filed.
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`1 Photoplethysmographic, photoplethysmogram, and photoplethysmography are all
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`terms abbreviated PPG. Other abbreviations, however, such as PTG, are also
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`occasionally used in the art. Margulies, Ex. 1013, ¶0054; Inukai, Ex. 1014, ¶0027;
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`Yoon, Ex. 1015, ¶0052.
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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`Ex. 1012, § 2.3. By February 2009, the earliest claimed priority date, PPG
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`technology was in widespread use and established as a simple, low-cost, readily-
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`portable choice for both clinical and non-clinical physiological measurements. Ex.
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`1012, § 2.3.
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`28. PPG is an optical technique whereby light is projected into living
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`tissue, and the reflected light is detected after its interaction with the skin, blood,
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`and other tissue. Ex. 1012, § 1. The intensity of the reflected light depends on the
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`volume of blood. Ex. 1012, § 1. The volume of blood fluctuates proportionally
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`with the cardiac cycle. Ex. 1012, § 1. As a result, a PPG sensor detects a time-
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`varying pulsatile waveform, or pulse wave, that is synchronized with each
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`heartbeat. Ex. 1012, § 1.
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`29. A 1972 patent illustrates many of the conventional components of a
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`PPG heart rate monitor using an optical technique to continuously measure the
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`pulse of a subject. Herczfeld, Ex. 1016. As shown below, the small probe housing
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`included a light source to emit light directly into the finger of a subject and a
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`photodetector to collect light directly from the finger. Ex. 1016, 2:60-3:22, FIG. 1
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`(annotated and reproduced below).
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`Light source
`Housing
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`Incident
`light
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`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
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`Photodetector
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`Reflected
`light
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`Ex. 1016, FIG. 1 (annotated).
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`30.
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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. 1016, 3:40-
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`42, FIG. 1; Webster, Ex. 1017, pp. 34-36. The intensity of the reflected light was
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`understood to be inversely proportional to the amount of blood flowing in the
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`finger. Ex. 1016, 3:42-55; Ex. 1017, pp. 40-49. For each heartbeat, blood pumped
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`into and out of the capillaries, thereby causing a periodic decrease and increase in
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`the reflected light intensity. Ex. 1016, 3:42-55; Ex. 1017, pp. 40-49. The detected
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`periodic waveform was known to represent a volume of the circulating blood
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`synchronized to each heartbeat. Ex. 1016, 3:42-55; Ex. 1017, pp. 40-49. This
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`pulsatile waveform was known as a photoplethysmographic pulse wave. Ex. 1017,
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`pp. 13-18, 40-49; Ex. 1012, § 2.1.
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`In Support of Inter Partes Review
` of U.S. Patent No. 8,942,776
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`Ex. 1017, p. 47.
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`31. Hence, PPG was an old, well-known optical measurement technique
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`used to detect blood volume changes in living tissue. Ex. 1012, § 1; Ex. 1017, pp.
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`240-241. The basic form of PPG technology requires only a few opto-electronic
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`components: a light source (often red or near infrared) to illuminate the tissue
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`(commonly at the ear, wrist, or finger) and a photodetector to measure the small
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`variations in light intensity associated with changes in blood volume. Ex. 1012, §§
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`1, 2.4; Ex. 1017, pp. 34-38. A simple, appropriately programmed signal processor
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`can extract heart rate, respiratory rate, blood oxygen saturation (SpO2), and a
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`variety of other physiological parameters. Ex. 1012, § 3; Schwartz, Ex. 1018, 5:5-
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`9, 10:6-20. The idealized model of absorbed and transmitted light in living tissue
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`(shown above) illustrates that pulsation of arterial blood can dominate the pulse
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`wave signal and the contribution from venous blood is therefore often ignored
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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`while the subject is at rest. It was also known, however, that body movement (such
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`as walking, running, and the like) can significantly affect venous blood flow and
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`hence the PPG signal, which cannot be ignored. Kosuda, Ex. 1019, ¶¶0230-0232,
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`0345-0347.
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`32. Photoplethysmography has had widespread clinical application, with
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`the technology being utilized in commercially available medical devices, such as
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`pulse oximeters. Ex. 1012, § 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
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`method for monitoring patients’ arterial oxygen saturation (SpO2). Ex. 1012, § 2.3;
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`Ex. 1017, Preface. Oxygen saturation of the hemoglobin in arterial blood is
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`determined by the relative proportions of oxygenated hemoglobin and reduced
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`hemoglobin in the arterial blood. Pologe, Ex. 1020, 1:20-56; Ex. 1017, pp. 34-38.
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`A pulse oximeter uses PPG signals to determine the oxygen saturation of the
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`hemoglobin by measuring the difference in the light absorption of these two forms
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`of hemoglobin. Ex. 1020, 1:20-56, FIG. 1 (a display module of a pulse oximeter is
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`shown below); Ex. 1017, pp. 34-38, FIG. 12.2. Reduced or deoxygenated
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`hemoglobin absorbs more light in the red band (600-800 nm) than does
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`oxyhemoglobin, while oxyhemoglobin absorbs more light in the near infrared band
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`(800-1000 nm) than does reduced hemoglobin. Ex. 1020, 1:20-56; Ex. 1017, pp.
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`34-38, 86-88. Oxygen saturation is then estimated based on the ratio between the
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`In Support of Inter Partes Review
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` of U.S. Patent No. 8,942,776
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`detected intensity of red and infrared light. Ex. 1020, 1:20-56; Ex. 1017, pp. 34-38.
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`Ex. 1020, FIG. 1
`(excerpted)
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`33. The pulse oximeter typically includes a probe which contains two
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`light emitting diodes, one red and one infrared, and is placed in contact with the
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`skin. Ex. 1020, 1:20-56; Ex. 1017, pp. 34-38. There were conventionally two types
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`of probes for pulse oximetry: reflectance and transmittance. Ex. 10