`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`Case IPR2020-01521
`U.S. Patent 10,292,628
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`MASIMO 2004
`Apple v. Masimo
`IPR2020-01521
`
`
`
`
`
`
`I.
`
`TABLE OF CONTENTS
`
`QUALIFICATIONS ........................................................................................ 1
`
`II. MATERIALS CONSIDERED ........................................................................ 8
`
`III. UNDERSTANDING OF PATENT LAW .................................................... 10
`
`A.
`
`B.
`
`C.
`
`Level Of Ordinary Skill In The Art ..................................................... 10
`
`Claim Construction ............................................................................. 11
`
`Obviousness ......................................................................................... 12
`
`IV.
`
`INTRODUCTION TO MASIMO’S TECHNOLOGY ................................. 13
`
`A.
`
`B.
`
`The ’628 Patent ................................................................................... 13
`
`Introduction To The Independent Claims Of The ’628
`Patent ................................................................................................... 14
`
`V.
`
`THE PETITION’S PROPOSED COMBINATIONS .................................... 18
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 20
`
`VII. GROUNDS 1A-1D DO NOT ESTABLISH
`OBVIOUSNESS ............................................................................................ 21
`
`A.
`
`Introduction To Ground 1A ................................................................. 21
`
`1.
`
`2.
`
`3.
`
`Aizawa Uses Peripherally Located Detectors
`Around A Single Centrally Located Emitter
`(LED) ........................................................................................ 22
`
`Inokawa Uses Peripherally Located Emitters
`(LEDs) Around A Single Centrally Located
`Detector ..................................................................................... 23
`
`Ground 1A’s Proposed Combination Of
`Aizawa And Inokawa ................................................................ 25
`
`B.
`
`Ground 1A Does Not Establish Obviousness ..................................... 27
`
`-i-
`
`
`
`
`
`1.
`
`2.
`
`A POSITA Would Not Have Been Motivated
`To Combine Inokawa’s Convex Lens With
`Aizawa’s Sensor ........................................................................ 27
`
`A POSITA Would Not Have Added A Second
`Emitter (LED) To Aizawa ........................................................ 49
`
`C.
`
`The Remaining Challenged Dependent Claims Are
`Nonobvious Over Ground 1A ............................................................. 55
`
`D. Ground 1B Does Not Establish Obviousness For The
`Same Reason As Ground 1A And For Additional
`Reasons ................................................................................................ 55
`
`1.
`
`2.
`
`Ohsaki Does Not Fix The Problems With
`Ground 1A’s Proposed Aizawa-Inokawa
`Combination .............................................................................. 56
`
`A POSITA Would Have Understood That
`Ohsaki’s Board Would Not Prevent Slipping
`With Aizawa’s Device .............................................................. 57
`
`E.
`
`F.
`
`The Challenged Dependent Claims Are Nonobvious
`Over Ground 1B .................................................................................. 60
`
`Grounds 1C-1D Fail For The Same Reasons As
`Ground 1A ........................................................................................... 61
`
`VIII. GROUNDS 2A-2B DO NOT ESTABLISH
`OBVIOUSNESS ............................................................................................ 61
`
`A.
`
`Introduction To Ground 2A ................................................................. 61
`
`1. Mendelson-1988 Uses Peripherally Located
`Detectors Around Centrally Located Emitters
`(LEDs) ....................................................................................... 61
`
`2.
`
`Ground 2A’s Proposed Combination Of
`Mendelson-1988 And Inokawa ................................................. 62
`
`B.
`
`Ground 2A Does Not Establish Obviousness ..................................... 64
`
`-ii-
`
`
`
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`Ground 2A Does Not Demonstrate A
`Motivation To Combine Mendelson-1988 And
`Inokawa, And Does Not Establish A
`Reasonable Expectation Of Success ......................................... 64
`
`Ground 2A’s Proposed Combination Does Not
`Include The Claimed Cover ...................................................... 68
`
`Ground 2A’s Proposed Combination Of
`Mendelson-1988 And Inokawa Does Not Have
`A “Circular Housing” With A “Light
`Permeable Cover” (Claim 7) ..................................................... 72
`
`Dr. Kenny Relies On References Not Identified
`As Part Of Ground 2A With No Analysis Of
`Any Motivation To Combine .................................................... 73
`
`C.
`
`The Challenged Dependent Claims Are Nonobvious
`Over Ground 2A .................................................................................. 76
`
`D. Ground 2B Fail For The Same Reason As Ground 2A ....................... 76
`
`IX. OATH ............................................................................................................ 77
`
`
`
`
`
`-iii-
`
`
`
`
`
`I, Vijay K. Madisetti, Ph.D., declare as follows:
`
`1.
`
`I have been retained by counsel for Patent Owner Masimo
`
`Corporation (“Masimo”) as an independent expert witness in this proceeding. I
`
`have been asked to provide my opinions regarding the Petition in this action and
`
`the declaration offered by Thomas W. Kenny, Ph.D., (Ex. 1003) challenging the
`
`patentability of claims 1-30 of U.S. Patent No. 10,292,628 (“the ’628 Patent”). I
`
`am being compensated at my usual and customary rate for the time I spend
`
`working on this proceeding, and my compensation is not affected by its outcome.
`
`I.
`QUALIFICATIONS
`2. My qualifications are set forth in my curriculum vitae, a copy of
`
`which is included as Exhibit 2005. A summary of my qualifications follows.
`
`3.
`
`I am a professor in Electrical and Computer Engineering at the
`
`Georgia Institute of Technology (“Georgia Tech”). I have worked in the area of
`
`digital signal processing, wireless communications, computer engineering,
`
`integrated circuit design, and software engineering for over 25 years, and have
`
`authored, co-authored, or edited several books and numerous peer-reviewed
`
`technical papers in these area.
`
`4.
`
`I obtained my Ph.D. in Electrical Engineering and Computer Science
`
`at the University of California, Berkeley, in 1989. While there, I received the
`
`-1-
`
`
`
`
`
`Demetri Angelakos Outstanding Graduate Student Award and the IEEE/ACM Ira
`
`M. Kay Memorial Paper Price.
`
`5.
`
`I joined Georgia Tech in the Fall of 1989 and am now a tenured full
`
`professor in Electrical and Computer Engineering. Among other things, I have
`
`been active in the areas of digital signal processing, wireless communications,
`
`integrated circuit design (analog & digital), system-level design methodologies and
`
`tools, and software engineering. I have been the principal investigator (“PI”) or
`
`co-PI in several active research programs in these areas, including DARPA’s
`
`Rapid Prototyping of Application Specific Signal Processors, the State of
`
`Georgia’s Yamacraw Initiative, the United States Army’s Federated Sensors
`
`Laboratory Program, and
`
`the United States Air Force Electronics Parts
`
`Obsolescence Initiative. I have received an IBM Faculty Award and NSF’s
`
`Research Initiation Award. I have been awarded the 2006 Frederick Emmons
`
`Terman Medal by
`
`the American Society of Engineering Education for
`
`contributions to Electrical Engineering, including authoring a widely used textbook
`
`in the design of VLSI digital signal processors.
`
`6.
`
`During the past 20 years at Georgia Tech, I have created and taught
`
`undergraduate and graduate courses in hardware and software design for signal
`
`processing, computer engineering (software and hardware systems), computer
`
`engineering and wireless communication circuits.
`
`-2-
`
`
`
`
`
`7.
`
`I have been involved in research and technology in the area of digital
`
`signal processing since the late 1980s, and I am the Editor-in-Chief of the CRC
`
`Press’s 3-volume Digital Signal Processing Handbook (1998, 2010).
`
`8.
`
`I have founded three companies in the areas of signal processing,
`
`embedded software, military chipsets involving imaging technology, and software
`
`for computing and communications systems. I have supervised Ph.D. dissertations
`
`of over twenty engineers in the areas of computer engineering, signal processing,
`
`communications, rapid prototyping, and system-level design methodology.
`
`9.
`
` I have designed several specialized computer and communication
`
`systems over the past two decades at Georgia Tech for tasks such as wireless audio
`
`and video processing and protocol processing for portable platforms, such as cell
`
`phones and PDAs. I have designed systems that are efficient in view of
`
`performance, size, weight, area, and thermal considerations. I have developed
`
`courses and classes for industry on these topics, and many of my lectures in
`
`advanced computer system design, developed under the sponsorship of the United
`
`States Department of Defense in the late 1990s, are available for educational use at
`
`http://www.eda.org/rassp and have been used by several U.S. and international
`
`universities as part of their course work. Some of my recent publications in the
`
`area of design of computer engineering and wireless communications systems and
`
`associated protocols are listed in Exhibit 2005.
`
`-3-
`
`
`
`
`
`10.
`
`In the mid 2006-2007 timeframe, I collaborated with Professor John
`
`Scharf and his colleagues at Emory Healthcare system in developing FFT-based
`
`pulse oximetry system prototypes on FPGAs, which extended technologies
`
`developed by Prof. Scharf and his colleagues from the 1996 time frame (See T.
`
`Rusch, R. Sankar, J. Scharf, “Signal Processing Methods for Pulse Oximetry”,
`
`Comput. Bio. Med, Vol. 26, No. 2, 1996). Some of my more recent publications in
`
`the area of biological signal processing and bioinformatics are listed in my CV and
`
`include, A. Bahga, V. Madisetti, “Healthcare Data Integration and Informatics in
`
`the Cloud”, IEEE Computer, Vol. 48, Issue 2, 2015, and “Cloud-Based
`
`Information Integration Informatics Framework for Healthcare Applications”,
`
`IEEE Computer, Issue 99, 2013. In addition to my signal processing experience
`
`specific to pulse oximetry, I also have experience in developing systems for other
`
`physiological signals. Beginning in the early 1990s, I worked, in particular, with
`
`ECG/EKG signals, and, in general, with biomedical signals and systems.
`
`11.
`
`In addition to my signal processing experience specific to pulse
`
`oximetry, I also have experience in developing algorithms and systems for other
`
`physiological signals. I worked with ECG/EKG signals in particular, and
`
`biomedical signals and systems in general, beginning in the early 1990s. In
`
`particular, I worked with graduate student Dr. Shahram Famorzadeh, in 1990 and
`
`1991, to analyze and apply pattern recognition (a category of signal processing
`
`-4-
`
`
`
`
`
`algorithms that is based on correlation with a set of templates) to ECG/EKG
`
`waveforms to identify physiological conditions.
`
`12.
`
`I have experience with biomedical signals and devices in the field of
`
`speech and image processing since the late 1980s. I worked on deconvolution
`
`algorithms to recover the state of the system based on observed measurements of
`
`the physiological signals in the 1993-1998 time-frame. These signal processing
`
`techniques can be applied to pulse oximetry signals, and I have been working with
`
`these techniques since the mid-1980s.
`
`13.
`
`I have studied, researched and published in the area of adaptive filter
`
`signal processing for noise reduction and signal prediction, using correlation-based
`
`approaches since the mid-1980s, both in the time-domain and frequency domain,
`
`and also to ray-tracing applications, such as Seismic Migration for oil and shale
`
`gas exploration. See for instance, V. Madisetti & D. Messerschmitt, Dynamically
`
`Reduced Complexity Implementation of Echo Cancellers, IEEE International
`
`Conference on Speech, Acoustics and Signal Processing, ICASSP 1986, Tokyo,
`
`Japan, and M. Romdhane and V. Madisetti, “All-Digital Oversampled Front-End
`
`Sensors” IEEE Signal Processing Letters, Vol. 3, Issue 2, 1996, and “LMSGEN: A
`
`Prototyping Environment for Programmable Adaptive Digital Filters in VLSI”,
`
`VLSI Signal processing, pp. 33-42, 1994.
`
`-5-
`
`
`
`
`
`14. Deconvolution of symmetric (seismic) and asymmetric (pulse
`
`oximetry) signals has gained much importance in the past two decades, and some
`
`of my early work on “Homomorphic Deconvolution of Bandpass Signals” in IEEE
`
`Transactions on Signal Processing, October 1997, established several new methods
`
`for deconvolution of such signals that had several advantages of robustness,
`
`increased accuracy, and simplicity.
`
`15.
`
`In the past decade I have authored several peer-reviewed papers in the
`
`area of computer systems, instruments, and software design, and these include:
`
`
`
`
`
`
`
`
`
`V. Madisetti, et al., “The Georgia Tech Digital Signal Multiprocessor,
`
`IEEE Transactions on Signal Processing, Vol. 41, No. 7, July 1993.
`
`V. Madisetti et al., “Rapid Prototyping on the Georgia Tech Digital
`
`Signal Multiprocessor”, IEEE Transactions on Signal Processing, Vol.
`
`42, March 1994.
`
`V. Madisetti, “Reengineering legacy embedded systems”, IEEE
`
`Design & Test of Computers, Vol. 16, Vol. 2, 1999.
`
`V. Madisetti
`
`et
`
`al.,
`
`“Virtual Prototyping of Embedded
`
`Microcontroller-based DSP Systems”, IEEE Micro, Vol. 15, Issue 5,
`
`1995.
`
`-6-
`
`
`
`
`
`
`
`V. Madisetti, et al., “Incorporating Cost Modeling in Embedded-
`
`System Design”, IEEE Design & Test of Computers, Vol. 14, Issue 3,
`
`1997.
`
`
`
`V. Madisetti, et al., “Conceptual Prototyping of Scalable Embedded
`
`DSP Systems”, IEEE Design & Test of Computers, Vol. 13, Issue 3,
`
`1996.
`
`
`
`
`
`V. Madisetti, Electronic System, Platform & Package Codesign,”
`
`IEEE Design & Test of Computers, Vol. 23, Issue 3, June 2006.
`
`V. Madisetti, et al., “A Dynamic Resource Management and
`
`Scheduling Environment
`
`for Embedded Multimedia
`
`and
`
`Communications Platforms”, IEEE Embedded Systems Letters, Vol.
`
`3, Issue 1, 2011.
`
`16.
`
`I have been active in the areas of signal processing systems and
`
`mobile device communication systems for several years, and some of my
`
`publications in this area include “Frequency Dependent Space-Interleaving of
`
`MIMO OFDM Systems” Proc. of IEEE Radio and Wireless Conference
`
`(RAWCON ’03), 2003, “Embedded Alamouti Space Time Codes for High Rate
`
`and Low Decoding Complexity”, Proc. IEEE Asilomar Conf. on Signals, Systems,
`
`and Computers, 2008; and “Asymmetric Golden Codes for Fast Decoding in Time
`
`Varying Channels”, Wireless Personal Communications (2011).
`
`-7-
`
`
`
`
`
`II. MATERIALS CONSIDERED
`17. Below is a listing of documents and materials that I considered and
`
`reviewed in connection with providing this declaration. In forming my opinions, I
`
`considered those materials as well as anything cited or discussed in this
`
`declaration.
`
`Exhibit
`
`1001
`1002
`1003
`1004
`1005
`
`1006
`1007
`1008
`
`1009
`1010
`1014
`1015
`
`1016
`
`Description
`
`U.S. Patent No. 10,292,628 to Poeze, et al. (“’628 Patent”)
`Excerpts from the Prosecution History of the ’628 Patent
`Declaration of Dr. Thomas W. Kenny
`Curriculum Vitae of Dr. Thomas W. Kenny
`Masimo Corporation, et al. v. Apple Inc., Complaint, Civil
`Action No. 8:20-cv-00048 (C.D. Cal.)
`U.S. Pub. No. 2002/0188210 (“Aizawa”)
`JP 2006-296564 (“Inokawa”)
`Certified English Translation of Inokawa and Translator’s
`Declaration
`U.S. Pat. No. 7,088,040 (“Ducharme”)
`U.S. Pat. No. 8,177,720 (“Nanba”)
`U.S. Pub. No. 2001/0056243 (“Ohsaki”)
`“Design and Evaluation of a New Reflectance Pulse Oximeter
`Sensor,” Y. Mendelson, et al.; Worcester Polytechnic Institute,
`Biomedical Engineering Program, Worcester, MA 01609;
`Association for the Advancement of Medical Instrumentation,
`Vol. 22, No. 4, 1988; pp. 167-173 (“Mendelson-1988”)
`“A Wearable Reflectance Pulse Oximeter
`for Remote
`Physiological Monitoring,” Y. Mendelson, et al.; Proceedings
`of the 28th IEEE EMBS Annual International Conference,
`2006; pp. 912-915 (“Mendelson-2006”)
`
`-8-
`
`
`
`
`
`Exhibit
`
`1018
`
`1019
`1020
`1021
`1022
`1023
`1024
`
`1025
`1027
`1028
`1029
`
`2006
`
`2007
`
`2010
`
`2012
`
`Description
`
`“Acrylic: Strong, stiff, clear plastic available in a variety of
`brilliant
`colors,”
`available
`at
`https://www.curbellplastics.com/Research-
`Solutions/Materials/Acrylic
`
`U.S. Pat. No. 7,031,728 (“Beyer”)
`U.S. Pat. No. 7,092,735 (“Osann, Jr.”)
`U.S. Pat. No. 6,415,166 (“Van Hoy”)
`QuickSpecs; HP iPAQ Pocket PC h4150 Series
`U.S. Pat. App. Pub. No. 2007/0145255 (“Nishikawa”)
`“Measurement Site and Photodetector Size Considerations in
`Optimizing Power Consumption of a Wearable Reflectance
`Pulse Oximeter,” Y. Mendelson, et al.; Proceedings of the 25th
`IEEE EMBS Annual International Conference, 2003; pp. 3016-
`3019 (“Mendelson-2003”)
`U.S. Pat. No. 6,801,799 (“Mendelson-’799”)
`U.S. Pub. No. 2007/0093786 (“Goldsmith”)
`U.S. Pub. No. 2004/0138568 (“Lo”)
`Wikipedia: The Free Encyclopedia, “Universal asynchronous
`receiver-transmitter”
`at
`https://en.wikipedia.org/wiki/Universal_asynchronous_receiver-
`transmitter, last accessed 08/27/2020
`Deposition Transcript of Dr. Thomas W. Kenny in Apple Inc. v.
`Masimo Corp., IPR2020-01520, IPR2020-01537, IPR2020-
`01539 (April 22, 2021)
`Deposition Transcript of Dr. Thomas W. Kenny in Apple Inc. v.
`Masimo Corp., IPR2020-01520, IPR2020-01537, IPR2020-
`01539 (April 23, 2021)
`Frank H. Netter, M.D., Section VI Upper Limb, Atlas of
`Human Anatomy (2003), Third Edition (“Netter”)
`Webster, Design of Pulse Oximeters (1997) (Exhibit 1019 in
`IPR2020-01536)
`
`-9-
`
`
`
`
`
`
`
`Exhibit
`
`2019
`2020
`
`2025
`Paper 2
`Paper 7
`
`Description
`
`Petition for Inter Partes Review IPR2020-01520
`Declaration of Dr. Thomas W. Kenny in Apple Inc. v. Masimo
`Corp., IPR2020-01520
`U.S. Pat. No. 10,258,265 (“Poeze”)
`Petition for Inter Partes Review IPR2020-01521
`Decision Granting Institution of Inter Partes Review IPR2020-
`01521
`
`III. UNDERSTANDING OF PATENT LAW
`I am not an attorney and will not be offering legal conclusions.
`
`18.
`
`However, I have been informed of several principles concerning the legal issues
`
`relevant to analyzing the challenges to the claims of the ’628 Patent, and I used
`
`these principles in arriving at my conclusions.
`
`A. Level Of Ordinary Skill In The Art
`19.
`I understand that certain issues in an IPR, such as claim construction
`
`and whether a claim is invalid as obvious, are assessed from the view of a
`
`hypothetical person of ordinary skill in the relevant art at the time of the invention.
`
`I understand there are multiple factors relevant to determining the level of ordinary
`
`skill in the art, including (1) the level of education and experience of persons
`
`working in the field at the time of the invention; (2) the sophistication of the
`
`technology; (3) the types of problems encountered in the field; and (4) the prior art
`
`solutions to those problems. I understand that this hypothetical person of ordinary
`
`skill is presumed to have had knowledge from the teachings of the prior art.
`
`-10-
`
`
`
`
`
`20.
`
`I understand that Apple Inc. (“Apple” or “Petitioner”) and its
`
`Declarant Dr. Kenny have set forth the following definition for a person of
`
`ordinary skill in the art (“POSITA”): “someone with a working knowledge of
`
`physiological monitoring technologies. The person would have had a Bachelor of
`
`Science degree in an academic discipline emphasizing the design of electrical,
`
`computer, or software technologies, in combination with training or at least one to
`
`two years of related work experience with capture and processing of data or
`
`information, including but not limited to physiological monitoring technologies.
`
`Alternatively, the person could have also had a Master of Science degree in a
`
`relevant academic discipline with less than a year of related work experience in the
`
`same discipline.” Ex. 1003 ¶21. I discuss the asserted level of skill further below,
`
`in Section VI of this declaration.
`
`B. Claim Construction
`21.
`I understand that claim construction in an IPR is a legal question for
`
`the Board to decide. I also understand, however, that in construing claim terms,
`
`the Board asks what the terms would mean to a person of ordinary skill in the
`
`relevant art in view of the disclosures in the patent and the prosecution history of
`
`the patent. I understand that the Board may also consider external evidence, such
`
`as dictionaries. In general, however, I understand that claim terms are given the
`
`-11-
`
`
`
`
`
`ordinary and customary meaning one of ordinary skill in the relevant art would
`
`apply to them in the context of the patent at the time the patent was filed.
`
`22.
`
`I understand that Apple did not identify any terms for construction. I
`
`have given the claim terms their plain and ordinary meaning in my analysis.
`
`C. Obviousness
`23.
`I understand that a patent claim is invalid under the patent law, 35
`
`U.S.C. § 103, if, at the time the claimed invention was made, the differences
`
`between the prior art and the claimed invention as a whole would have been
`
`obvious to a person of ordinary skill in the art. I understand that the following
`
`facts are considered in determining whether a claimed invention is invalid as
`
`obvious in view of the prior art: (1) the scope and content of the prior art; (2) the
`
`level of ordinary skill in the art; and (3) the differences, if any, between the
`
`claimed invention and the prior art.
`
`24.
`
`I also understand there are additional considerations that may be used
`
`in evaluating whether a claimed invention is obvious. These include whether the
`
`claimed invention was the result of (a) a teaching, suggestion, or motivation in the
`
`prior art that would have led one of ordinary skill to modify the prior art to arrive
`
`at the claimed invention; (b) a combination of prior art elements combined
`
`according to known methods to yield predictable results; (c) a simple substitution
`
`of one known element for another to obtain a predicable result; (d) the use of a
`
`-12-
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`
`
`
`known technique to improve similar things in the same way; (e) applying a known
`
`technique to a known thing ready for improvement to yield predictable results; (f)
`
`choosing from a finite number of identified, predictable solutions, with a
`
`reasonable expectation of success; (g) known work in one field of endeavor
`
`prompting variations of it for use in either the same filed or a different one based
`
`on design incentives or other market forces if the variations are predictable to one
`
`of ordinary skill in the art.
`
`25.
`
`26.
`
`I have applied this understanding in my analysis.
`
`I understand that Dr. Kenny carried out his analysis of patentability as
`
`of July 3, 2008. Ex. 1003 ¶16. I likewise carry out my analysis of patentability as
`
`of July 3, 2008. I do not offer any opinions regarding priority in this declaration.
`
`IV.
`INTRODUCTION TO MASIMO’S TECHNOLOGY
`A. The ’628 Patent
`27. Masimo’s U.S. Patent No. 10,292,628 (the “’628 Patent”) is generally
`
`directed to optical physiological measurement sensors and devices that use a
`
`combination of different design elements to improve detection efficiency.
`
`Masimo’s claimed non-invasive optical physiological measurement sensor or
`
`device includes multiple detectors, multiple emitters, and a cover with a protruding
`
`surface that together enhance the sensor’s or device’s effectiveness. The ’628
`
`Patent explains that these different components work together to provide greater
`
`-13-
`
`
`
`
`
`noise cancellation and an order of magnitude increase in signal strength. Ex. 1001
`
`9:7-12, 20:4-20; see also 3:6-16, 4:8-18. Among other things, the ’628 Patent
`
`helps address problems of light attenuation and errors due to the variations in the
`
`path of light passing through tissue. The ’628 Patent identifies several different
`
`benefits to the use of a protruding surface. For example, the protruding surface
`
`thins out a measurement site, resulting in less light attenuation by a measured
`
`tissue. Ex. 1001 7:38-41. The protruding surface further increases the area from
`
`which attenuated light can be measured. Ex. 1001 7:41-43. The multiple detectors
`
`in the sensor or device of the ’628 Patent allow for an averaging of measurements,
`
`which can, in turn, reduce errors due to variations in the path of light passing
`
`through the tissue. Ex. 1001 9:7-12; see also 3:6-16, 4:8-18.
`
`B.
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`Introduction To The Independent Claims Of The ’628 Patent
`28. The ’628 Patent has three independent claims: claims 1, 7, and 20.
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`Claims 1, 7, and 20 each claim a noninvasive optical physiological measurement
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`sensor or device that includes, among other things, (1) a plurality of emitters, (2) at
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`least four detectors, and (3) either a cover that comprises a protruding surface and
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`is configured to be located between tissue of the user and the plurality of detectors
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`(claims 1 and 20) or a cover comprising a protruding surface that is arranged to
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`allow passage of light to the at least four detectors (claim 7).
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`29. Claim 1 requires a light permeable cover comprising an outwardly
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`protruding convex surface through which the plurality of detectors are configured
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`to receive light. Claim 1 reads:
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`1. A noninvasive optical physiological sensor comprising:
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`a plurality of emitters configured to emit light into tissue of a
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`user;
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`a plurality of detectors configured to detect light that has been
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`attenuated by tissue of the user, wherein the plurality of detectors
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`comprise at least four detectors;
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`a housing configured to house at least the plurality of detectors;
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`and
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`a light permeable cover configured to be located between tissue
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`of the user and the plurality of detectors when the noninvasive optical
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`physiological sensor is worn by the user, wherein the cover comprises
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`an outwardly protruding convex surface configured to cause tissue of
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`the user to conform to at least a portion of the outwardly protruding
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`convex surface when the noninvasive optical physiological sensor is
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`worn by the user and during operation of the noninvasive optical
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`physiological sensor, and wherein the plurality of detectors are
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`configured to receive light passed through the outwardly protruding
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`convex surface after attenuation by tissue of the user.
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`30. Claim 7 requires a light permeable cover comprising wherein at least
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`a portion of the cover comprises a protruding surface that is arranged to allow
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`passage of light to at least four detectors. Claim 7 reads:
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`7. An optical physiological measurement device comprising:
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`a plurality of emitters configured to emit light into tissue of a
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`user;
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`a circular housing including a planar surface;
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`at least four detectors arranged on the planar surface of the
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`circular housing, wherein the four detectors are arranged in a grid
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`pattern; and
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`a light permeable cover of the circular housing, and wherein at
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`least a portion of the cover comprises a protruding surface that is
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`arranged to allow passage of light to the at least four detectors after
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`attenuation by tissue of the user.
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`31. Claim 20 requires a light permeable cover comprising an outwardly
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`protruding convex surface through which the plurality of detectors are configured
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`to receive light. Claim 20 reads:
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`20. A noninvasive optical physiological sensor comprising:
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`user;
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`a plurality of emitters configured to emit light into tissue of a
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`a plurality of detectors configured to detect light that has been
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`attenuated by tissue of the user, wherein the plurality of detectors
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`comprise at least four detectors;
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`a housing configured to house at least the plurality of detectors;
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`and
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`a light permeable cover configured to be located between tissue
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`of the user and the plurality of detectors when the noninvasive optical
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`physiological sensor is worn by the user, wherein the cover comprises
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`an outwardly protruding surface configured to cause tissue of the user
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`to conform to at least a portion of the outwardly protruding surface
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`when the noninvasive optical physiological sensor is worn by the user
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`and during operation of the noninvasive optical physiological sensor,
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`and wherein the outwardly protruding surface is further configured to
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`allow passage of light to the plurality of detectors after attenuation by
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`tissue of the user.
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`32. Dr. Kenny applies the same combination of references against claim 1
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`(Ex. 1003 ¶¶72-98, 142-146, 171-186), claim 7 (Ex. 1003 ¶¶108-115, 142-146,
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`198-205), and claim 20 (Ex. 1003 ¶¶130-134, 142-146, 216-220). Dr. Kenny’s
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`analysis generally treats claims 1, 7, and 20 similarly, and Dr. Kenny relies on and
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`incorporates his analysis for claim 1 into his analysis of claims 7 and 20. Ex. 1003
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`¶¶108-115, 130-134, 146, 171-186, 198-205, 216-220. In addressing Dr. Kenny’s
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`opinions, my analysis therefore likewise applies to claims 1, 7, and 20.
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`V. THE PETITION’S PROPOSED COMBINATIONS
`33. Petitioner presents six grounds. Grounds 1A-1D (the “Aizawa
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`grounds”) combine at least Aizawa (Ex. 1006) and Inokawa (Ex. 1007, translation
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`at Ex. 1008). Pet. 1-2.
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` Ground 1A combines Aizawa and Inokawa. Ground 1A challenges
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`claims 1-15, 17, 20-26, and 28.
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` Ground 1B adds Ohsaki (Ex. 1014) to the combination of Aizawa and
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`Inokawa. Petitioner characterizes Ohsaki as providing an additional
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`motivation and rationale to modify Aizawa to add a light permeable
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`cover comprising a protrusion. Pet. 45. Ground 1B challenges claims
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`1-15, 17, 20-26, and 28.
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` Ground 1C combines Aizawa, Inokawa, Mendelson-2006 (Ex. 1016),
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`and Beyer (Ex. 1019). Ground 1C challenges claims 18, 19, 29, and
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`30.
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` Ground 1D combines Aizawa, Inokawa, Goldsmith (Ex. 1027), and
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`Lo (Ex. 1028). Ground 1D challenges claims 18, 19, 29,, and 30.
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`34. Grounds 2A-2B (the “Mendelson grounds”) combine at
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`least
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`Mendelson-1988 (Ex. 1015) and the same Inokawa reference used in Grounds 1A-
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`1D. Pet. 2.
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` Ground 2A combines Mendelson-1988 and Inokawa. Ground 2A
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`challenges claims 1-17 and 20-28.
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` Ground 2B combines Mendelson-1988, Inokawa, Mendelson-2006,
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`and Beyer. Mendelson-2006 and Beyer are the same Mendelson-2006
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`and Beyer references used in Ground 1C. Ground 2B challenges
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`claims 18, 19, 29, and 30.
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`35. Aizawa and Mendelson-1988 share the same general arrangement of
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`peripheral detectors positioned radially around a central light source. Ex. 1006
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`Fig. 1A; Ex. 1015 Figs. 2A-B. In contrast, Inokawa arranges two LEDs on the
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`outside edge of its sensor and one detector in the center of the sensor. Ex. 1008
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`Fig. 2. I understand that Petitioner asserts a person of ordinary skill in the art
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`would have incorporated Inokawa’s convex lens into Aizawa or Mendelson-1988’s
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`sensor with the motivation to “increase the light collection efficiency.” Pet. 15, 64.
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`As I discuss below, a POSITA would have not incorporated Inokawa’s convex lens
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`into Aizawa or Mendelson-1988’s sensor with the motivation to “increase the light
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`collection efficiency” because a POSITA would have understood that Inokawa’s
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`convex lens would collect incoming light towards the center of the sensor. Unlike
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`Inokawa, which has its detector in the center, between an emitter on either side,
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`Aizawa and Mendelson-1988 have detectors placed at the edge (or periphery) of
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`the sensor. Thus, a POSITA would have believed that Inokawa’s convex lens,
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`which was designed to concentrate light at the center-located detector and increase
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`the optical signal, would have the opposite effect when used with Aizawa or
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`Mendelson-1988’s peripherally located detectors and would decrease the light
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`collection efficiency of the sensor.
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`VI. LEVEL OF ORDINARY SKILL IN THE ART
`36. Petitioner asserts that a POSITA “would have been a person with a
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`working knowledge of physiological monitoring technologies. The person would
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