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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`DECLARATION OF DR. MAJID SARRAFZADEH
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`- i -
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`Apple Inc.
`APL1003
`U.S. Patent No. 8,923,941
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`V.
`
`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`I.
`II. Qualifications ................................................................................................... 3
`III. Legal Principles ............................................................................................... 5
`IV. Background and State of the Art............................................................10
`A. Wearable Technology ............................................................................16
`B. Communication ......................................................................................19
`C. Noise Artifacts .......................................................................................20
`D. Adaptive Filtering Techniques ...............................................................24
`The ’941 Patent ..............................................................................................27
`A. Summary of the Prosecution History .....................................................28
`B. Level of Ordinary Skill of a Person in the Art.......................................29
`C. Claim Construction ................................................................................30
`1. “a body” ........................................................................................30
`2. “headset” .......................................................................................30
`3. “housing” ......................................................................................31
`4. “chipset” ........................................................................................32
`5. “window” ......................................................................................33
`VI. Ground 1: Claims 14–15 and 21 are unpatentable under pre-AIA 35 U.S.C.
`§ 103(a) over Kosuda in view of Maekawa. ..................................................34
`A. Overview of Kosuda ..............................................................................34
`B. Overview of Maekawa ...........................................................................39
`C. Claim 14 .................................................................................................42
`[14.P] A wearable device ....................................................................42
`[14.1] a housing ...................................................................................43
`[14.2] a chipset enclosed within the housing ......................................43
`[14.3] at least one PPG sensor .............................................................45
`[14.4] at least one motion sensor .........................................................47
`[14.5] at least one signal processor configured to process signals from
`the at least one motion sensor and signals from the at least one
`PPG sensor to reduce motion artifacts from the PPG signals ......47
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`- ii -
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`[14.6] the housing comprises at least one window that optically
`exposes the at least one PPG sensor to a body of a subject wearing
`the device ......................................................................................50
`[14.7] the housing comprises non-air light transmissive material in
`optical communication with the at least one PPG sensor and the
`window ..........................................................................................51
`D. Claim 15 .................................................................................................54
`E. Claim 21 .................................................................................................55
`VII. Ground 2: Claims 18–20 are unpatentable under pre-AIA 35 U.S.C. § 103(a)
`over Kosuda in view of Maekawa and Han. ..................................................56
`F. Claims 18-20 ..........................................................................................56
`1. Overview of Han ...........................................................................58
`G. Rationale to Combine the Teachings of Kosuda, Maekawa, and Han ..62
`VIII. Ground 3: Claims 14-19 and 21 are unpatentable under pre-AIA 35 U.S.C.
`§ 103(a) over Aceti in view of Fricke. ..........................................................63
`A. Overview of Aceti ..................................................................................63
`B. Overview of Fricke ................................................................................66
`C. Claim 14 .................................................................................................71
`[14.P] A wearable device ....................................................................71
`[14.1] a housing ...................................................................................72
`[14.2] a chipset enclosed within the housing ......................................72
`[14.3] at least one PPG sensor .............................................................74
`[14.4] at least one motion sensor .........................................................75
`[14.5] at least one signal processor configured to process signals from
`the at least one motion sensor and signals from the at least one
`PPG sensor to reduce motion artifacts from the PPG signals ......75
`[14.6] the housing comprises at least one window that optically
`exposes the at least one PPG sensor to a body of a subject wearing
`the device ......................................................................................78
`[14.7] the housing comprises non-air light transmissive material in
`optical communication with the at least one PPG sensor and the
`window ..........................................................................................79
`D. Claim 15 .................................................................................................79
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`- iii -
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`E. Claims 16 and 17 ................................................................................. ..8O
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`F. Claims 18 and 19 ................................................................................. ..80
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`G. Claim 21 ............................................................................................... ..85
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`E. Claims 16 and 17 ...................................................................................80
`F. Claims 18 and 19 ...................................................................................80
`G. Claim 21 .................................................................................................85
`IX. Ground 4: Claim 20 is unpatentable under pre-AIA 35 U.S.C. § 103(a) over
`Ground 4: Claim 20 is unpatentable under pre—AIA 35 U.S.C. § 103(a) over
`Aceti in view of Fricke and Comtois. ............................................................85
`Aceti in View of Fricke and Comtois ........................................................... ..85
`A. Overview of Comtois .............................................................................85
`B. Rationale to Combine the Teachings of Aceti, Fricke, and Comtois ....88
`B. Rationale to Combine the Teachings of Aceti, Fricke, and Comtois ....88
`Conclusion .....................................................................................................88
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`IX.
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`X.
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`A. Overview of Comtois ........................................................................... ..85
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`Conclusion ................................................................................................... ..88
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`- iv -
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`_iV_
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`
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`Exhibit No.
`1001
`
`1002
`1004
`1006
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`1008
`
`1009
`
`1010
`
`1011
`
`1016
`
`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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`1024
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`1025
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`1026
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`EXHIBIT LIST
`
`Description
`U.S. Patent No. 8,923,941 to LeBoeuf et al., issued December 30,
`2014
`U.S. Patent No. 8,923,941 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. 2008/0081972 to
`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 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 et
`al., published June 5, 2008
`U.S. Patent Application Publication No. 2008/0177162 to Bae,
`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,
`
`- v -
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`
`
`Exhibit No.
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
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`1034
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`1035
`
`1036
`
`1037
`
`1038
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`1039
`1040
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`1041
`
`1042
`
`1043
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`1044
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`1045
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`
`
`Description
`Eleventh Edition, 2008; p. 603
`U.S. Patent Application Publication No. 2004/0186387 to Kosuda
`et al., published September 23, 2004
`U.S. Patent Application No. 2009/0287067 to Dorogusker et al.,
`published November 19, 2009
`Japanese Patent Application Publication No. 2005/270544 to
`Maekawa, published October 6, 2005
`Certified English-language translation of Japanese Patent
`Application Publication No. 2005/270544 to Maekawa, published
`October 6, 2005
`U.S. Patent Application No. 2005/059870 to Aceti, published
`March 17, 2005
`G. Comtois & Y. Mendelson, A Comparative Evaluation of
`Adaptive Noise Cancellation Algorithms for Minimizing Motion
`Artifacts in a Forehead-Mounted Wearable Pulse Oximeter, IEEE
`(2007)
`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
`International Patent Application Publication No. 2007/013054 to
`Schwartz, published February 1, 2007
`U.S. Patent No. 5,575,284 to Athan et al., issued November 19,
`1996
`U.S. Patent No. 5,503,016 to Koen, issued April 2, 1996
`U.S. Patent Application Publication No. 2008/0154098 to Morris et
`al., published June 26, 2008
`U.S. Patent Application Publication No. 2007/0027367 to Oliver et
`al., published February 1, 2007
`U.S. Patent Application Publication No. 2007/0197881 to Wolf et
`al., published August 23, 2007
`U.S. Patent Application Publication No. 2005/0075542 to
`Goldreich, published April 7, 2005
`International Patent Application Publication No. WO2007/004089
`to Moroney et al., published January 11, 2007
`G. Sen Gupta et al., Design of a Low-cost Physiological Parameter
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`- vi -
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`Exhibit No.
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`1046
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`1047
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`1048
`1049
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`1050
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`1051
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`1053
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`1054
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`
`Description
`Measurement and Monitoring Device,
`Instrumentation and
`Measurement Technology Conference, IEEE (2007)
`U.S. Patent Application Publication No. 2006/0084879 to Nazarian
`et al., published April 20, 2006
`U.S. Patent No. 5,243,992 to Eckerle et al., issued September 14,
`1993
`U.S. Patent No. 4,955,379 to Hall, issued September 11, 1990
`International Patent Application Publication No. WO 2007/122375
`to Crowe et al., published November 1, 2007
`Excerpt from Wiley Electrical and Electronics Engineering
`Dictionary, 2004; p. 110
`Excerpt from Dictionary of Computer and Internet Terms, 2009; p.
`90
`U.S. Patent No. 6,801,799 to Mendelson et al., issued October 5,
`1990
`U.S. Patent No. 6,898,451 to Wuori, issued May 24, 2005
`
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`- vii -
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`I.
`
`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. 8,923,941 (“the
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`’941 patent”), titled “Methods and Apparatus for Generating Data Output
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`Containing Physiological and Motion-Related Information,” 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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`’941 Patent (Ex. 1001) and its file history (Ex. 1002). The ’941 Patent relates to a
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`“physiological monitoring apparatus” and describes “a method of generating a data
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`string containing physiological and motion-related information.” Ex. 1001, 1:21,
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`Abstract. I am familiar with the technology and state of the art described in the
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`’941 Patent as of its February 19, 2014 filing date, as well as the technology and
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`state of the art as of its 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 that the accompanying exhibits are true
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`and accurate copies of what they purport to be, and that an expert in the field
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`would 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 ’941 Patent and the references that
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`form the basis for the four grounds of unpatentability set forth in the Petition for
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`Inter Partes Review of the ’941 Patent.
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`Ground
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`References
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`Basis
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`Claims Challenged
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`1
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`2
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`3
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`4
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`Kosuda & Maekawa
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`§ 103 14, 15, 21
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`Kosuda, Maekawa, & Han
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`§ 103 18–20
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`Aceti & Fricke
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`§ 103 14-19, 21
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`Aceti, Fricke, & Comtois
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`§ 103 20
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`- 2 -
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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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`- 3 -
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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 standard rate of $650 per hour for my
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`work on this case. My compensation is not dependent upon my opinions or
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`testimony or the 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 ’941 Patent claims. I understand that the disclosures of the ’941 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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`- 5 -
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`been instructed to consider the time of the purported invention of the ’941 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 ’941 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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`- 8 -
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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 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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`- 9 -
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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. Background and State of the Art
`26. 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. Ex. 1021 (Allen - Photoplethysmography and its application in clinical
`
`physiological measurement), § 1. The technique was introduced in 1937 and had
`
`become a ubiquitous part of physiological monitoring long before the ʼ941 Patent
`
`
`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. Ex. 1034 (Margulies – US 2004/0059236), ¶ 0054; Ex.
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`1035 (Inukai – US 20070016086), ¶ 0027; Ex. 1036 (Yoon – US 2003/0236647), ¶
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`0052.
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`- 10 -
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`was filed. Ex. 1021, § 2.3. By 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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`1021, § 2.3.
`
`27. 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. 1021, § 1. The intensity of the reflected light depends on the
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`volume of blood. Ex. 1021, § 1. The volume of blood fluctuates proportionally
`
`with the cardiac cycle. Ex. 1021, § 1. As a result, a PPG sensor detects a time-
`
`varying pulsatile waveform, or pulse wave, that is synchronized with each
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`heartbeat. Ex. 1021, § 1.
`
`28. 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. Ex. 1018 (Herczfeld - US 3,704,706). As shown below, the
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`small probe housing included a light source to emit light directly into the finger of
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`a subject and a photodetector to collect light directly from the finger. Ex. 1018,
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`2:60-3:22, fig. 1 (annotated, reproduce below).
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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 (annotations added).
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`29.
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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 (Webster – Design of Pulse Oximeters), pp. 34-36. The
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`intensity of the reflected light was understood to be inversely proportional to the
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`amount of blood flowing in the finger. Ex. 1018, 3:42-55; Ex. 1020, pp. 40-49. For
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`each heartbeat, blood pumped into and out of the capillaries, thereby causing a
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`periodic decrease and increase in the reflected light intensity. Ex. 1018, 3:42-55;
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`Ex. 1020, pp. 40-49. The detected periodic waveform was known to represent a
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`volume of the circulating blood synchronized to each heartbeat. Ex. 1018, 3:42-55;
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`Ex. 1020, pp. 40-49. This pulsatile waveform was known as a
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`photoplethysmographic pulse wave. Ex. 1020, pp. 13-18, 40-49; Ex. 1021, § 2.1.
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`
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`Ex. 1020, p. 47.
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`30. Hence, PPG was an old, well-known optical measurement technique
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`used to detect blood volume changes in living tissue. Ex. 1021, § 1; Ex. 1020, 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. 1021, §§
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`1, 2.4; Ex. 1020, 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. 1021, § 3; Ex 10XX (Schwartz -
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`WO 2007/013054), 5:5-9, 10:6-20. The idealized model of absorbed and
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`transmitted light in living tissue (shown above) illustrates that pulsation of arterial
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`blood can dominate the pulse wave signal and the contribution from venous blood
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`
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`is therefore often ignored while the subject is at rest. It was also known, however,
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`that body movement (such as walking, running, and the like) can significantly
`
`affect venous blood flow and hence the PPG signal, which cannot be ignored. Ex.
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`1027 (Kosuda – US 2004/0186387), ¶¶ 230-232, 0345-0347.
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`
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`31. Photoplethysmography has had widespread clinical application, with
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`the technology utilized in commercially available medical devices, such as pulse
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`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
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`method for monitoring patients’ arterial oxygen saturation (SpO2). Ex. 1021, § 2.3;
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`Ex. 1020, preface. Oxygen saturation of the hemoglobin in arterial blood is
`
`determined by the relative proportions of oxygenated hemoglobin and reduced
`
`hemoglobin in the arterial blood. Ex. 1019 (Pologe - US 5,297,548), 1:20-56; Ex.
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`1020, pp. 34-38. A pulse oximeter uses PPG signals to determine the oxygen
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`saturation of the hemoglobin by measuring the difference in the light absorption of
`
`these two forms of hemoglobin. Ex. 1019, 1:20-56, fig. 1 (a display module of a
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`- 14 -
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`
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`pulse oximeter is shown below); Ex. 1020, pp. 34-38, fig. 12.2. Reduced or
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`deoxygenated hemoglobin absorbs more light in the red band (600-800 nm) than
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`does oxyhemoglobin, while oxyhemoglobin absorbs more light in the near infrared
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`band (800-1000 nm) than does reduced hemoglobin. Ex. 1019, 1:20-56; Ex. 1020,
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`pp. 34-38, 86-88. Oxygen saturation is then estimated based on the ratio between
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`the detected intensity of red and infrared light. Ex. 1019, 1:20-56; Ex. 1020, pp.
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`34-38.
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`32. 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. 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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`Reflectance Probe
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`
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`Ex. 1020, pp. 87-88, figs. 7.1, 7.2.
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`
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`Transmittance Probe
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`
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`33. 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.
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`- 15 -
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`
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`1020, preface. The model 9500 pulse oximeter from Nonin Medical, Inc., shown in
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`the figure below, was a small sensor commercially available more than a decade
`
`before the effective filing date of the ’941 Patent. Ex. 1020, p. 207, fig. 12.5. With
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`light weight and an extremely small size, it displays heart rate and oxygen
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`saturation (SpO2).
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`
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`Ex. 1020, p. 207, fig. 12.5.
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`A. Wearable Technology
`In recent decades, the desire for small, reliable, low-cost and simple-
`34.
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`to-use noninvasive (cardiovascular) assessment techniques were key factors that
`
`have propelled the use of photoplethysmography. Ex. 1021, § 2.3. Advances in
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`opto-electronics and clinical instrumentation have also significantly contributed to
`- 16 -
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`
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`its advancement. Ex. 1021, § 2.3. The developments in semiconductor technology,
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`light emittin