UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`Case IPR2021-00209
`U.S. Patent 10,376,191
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`Masimo Ex. 2004
`Apple v. Masimo
`IPR2021-00209
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`Case IPR2021-00209
`U.S. Patent 10,376,191
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`Masimo Ex. 2004
`Apple v. Masimo
`IPR2021-00209
`
`
`
`
`
`
`I.
`
`TABLE OF CONTENTS
`
`QUALIFICATIONS ........................................................................................ 1
`
`II. MATERIALS CONSIDERED ........................................................................ 8
`
`III. UNDERSTANDING OF PATENT LAW ...................................................... 9
`
`A.
`
`B.
`
`C.
`
`Level Of Ordinary Skill In The Art ..................................................... 10
`
`Claim Construction ............................................................................. 11
`
`Obviousness ......................................................................................... 11
`
`IV.
`
`INTRODUCTION TO MASIMO’S TECHNOLOGY ................................. 13
`
`A.
`
`B.
`
`The ’191 Patent ................................................................................... 13
`
`Introduction To The Independent Claims Of The ’191
`Patent ................................................................................................... 14
`
`V.
`
`THE PETITION’S PROPOSED COMBINATIONS .................................... 16
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 18
`
`VII. GROUNDS 1A-1B DO NOT ESTABLISH
`OBVIOUSNESS ............................................................................................ 19
`
`A.
`
`Introduction To Ground 1A ................................................................. 19
`
`1.
`
`2.
`
`3.
`
`Aizawa Uses Peripherally Located Detectors
`Around A Single Centrally Located Emitter
`(LED) ........................................................................................ 19
`
`Inokawa Uses Peripherally Located Emitters
`(LEDs) Around A Single Centrally Located
`Detector ..................................................................................... 21
`
`Ground 1A’s Proposed Combination Of
`Aizawa And Inokawa ................................................................ 22
`
`B.
`
`Ground 1A Does Not Establish Obviousness ..................................... 24
`
`-i-
`
`
`
`
`
`1.
`
`2.
`
`A POSITA Would Not Have Been Motivated
`To Combine Inokawa’s Convex Lens With
`Aizawa’s Sensor ........................................................................ 24
`
`A POSITA Would Not Have Added A Second
`Emitter (LED) To Aizawa ........................................................ 48
`
`C.
`
`The Remaining Challenged Dependent Claims Are
`Nonobvious Over Ground 1A ............................................................. 54
`
`D. Ground 1B Does Not Establish Obviousness For The
`Same Reason As Ground 1A And For Additional
`Reasons ................................................................................................ 54
`
`1.
`
`2.
`
`Ohsaki Does Not Fix The Problems With
`Ground 1A’s Proposed Aizawa-Inokawa
`Combination .............................................................................. 55
`
`A POSITA Would Have Understood That
`Ohsaki’s Board Would Not Prevent Slipping
`With Aizawa’s Device .............................................................. 56
`
`E.
`
`The Challenged Dependent Claims Are Nonobvious
`Over Ground 1B .................................................................................. 59
`
`VIII. GROUND 2 DOES NOT ESTABLISH OBVIOUSNESS ........................... 60
`
`A.
`
`Introduction To Ground 2 ................................................................... 60
`
`1. Mendelson-1988 Uses Peripherally Located
`Detectors Around Centrally Located Emitters
`(LEDs) ....................................................................................... 60
`
`2.
`
`Ground 2’s Proposed Combination Of
`Mendelson-1988 And Inokawa ................................................. 61
`
`B.
`
`Ground 2 Does Not Establish Obviousness ........................................ 63
`
`-ii-
`
`
`
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`Ground 2 Does Not Demonstrate A Motivation
`To Combine Mendelson-1988 And Inokawa,
`And Does Not Establish A Reasonable
`Expectation Of Success ............................................................. 63
`
`Ground 2’s Proposed Combination Does Not
`Include The Claimed Cover (Claim 9) ..................................... 67
`
`Ground 2’s Proposed Combination Of
`Mendelson-1988 And Inokawa Does Not Have
`A “Plurality Of Detectors In A Circular Portion
`Of The Housing” And A “Lens Configured To
`Be Located Between Tissue Of The User And
`The Plurality Of Detectors” (Claim 1) ...................................... 69
`
`Dr. Kenny Relies On References Not Identified
`As Part Of Ground 2 With No Analysis Of Any
`Motivation To Combine ............................................................ 71
`
`C.
`
`The Challenged Dependent Claims Are Nonobvious
`Over Ground 2 ..................................................................................... 73
`
`IX. OATH ............................................................................................................ 74
`
`
`
`
`
`-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 1-6, 8-16, 18, and 19 of U.S. Patent No. 10,376,191 (“the
`
`’191 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 areas.
`
`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 Prize.
`
`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 timeframe (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
`1006
`1007
`1008
`
`1009
`1010
`1014
`1015
`
`1018
`
`1023
`
`Description
`
`U.S. Patent No. 10,376,191 to Poeze, et al. (“’191 Patent”)
`Excerpts from the Prosecution History of the ’191 Patent
`Declaration of Dr. Thomas W. Kenny
`Curriculum Vitae of Dr. Thomas W. Kenny
`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”)
`“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. App. Pub. No. 2007/0145255 (“Nishikawa”)
`
`-8-
`
`
`
`
`
`
`
`Exhibit
`
`1024
`
`1025
`1038
`
`2006
`
`2007
`
`2010
`
`2012
`
`2019
`2020
`
`2025
`Paper 2
`Paper 7
`
`Description
`
`“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. Pat. No. 8,577,431 (“CIP Patent”)
`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)
`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 IPR2021-00209
`Decision Granting Institution of Inter Partes Review IPR2021-
`00209
`
`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
`
`-9-
`
`
`
`
`
`relevant to analyzing the challenges to the claims of the ’191 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.
`
`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.
`
`-10-
`
`
`
`
`
`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
`
`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
`
`-11-
`
`
`
`
`
`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
`
`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.
`
`I have applied this understanding in my analysis.
`
`-12-
`
`
`
`
`
`26.
`
`I understand that Dr. Kenny carried out his analysis of patentability as
`
`of July 2, 2009. Ex. 1003 ¶16. I likewise carry out my analysis of patentability as
`
`of July 2, 2009. My opinions would not change if my analysis of patentability
`
`were carried out as of July 3, 2008. I do not offer any opinions regarding priority
`
`in this declaration.
`
`IV.
`INTRODUCTION TO MASIMO’S TECHNOLOGY
`A. The ’191 Patent
`27. Masimo’s U.S. Patent No. 10,376,191 (the “’191 Patent”) is generally
`
`directed to optical physiological sensors that use a combination of different design
`
`elements to improve detection efficiency. Masimo’s claimed optical physiological
`
`measurement sensors include multiple detectors, multiple emitters, and a lens with
`
`a protruding surface that together enhance the sensors’ effectiveness. The ’191
`
`Patent explains that these different components work together to provide greater
`
`noise cancellation and an order of magnitude increase in signal strength. Ex. 1001
`
`9:13-18, 20:8-24; see also 3:10-21, 4:13-24. Among other things, the ’191 Patent
`
`helps address problems of light attenuation and errors due to the variations in the
`
`path of light passing through tissue. The ’191 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 7:43-46. The protruding surface further increases the area from
`
`-13-
`
`
`
`
`
`which attenuated light can be measured. Ex. 1001 7:46-48. The multiple detectors
`
`in the sensor or device of the ’191 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 9:13-18; see also 3:10-21, 4:13-24.
`
`B.
`
`Introduction To The Independent Claims Of The ’191 Patent
`28. The ’191 Patent has two independent claims: claims 1 and 9. Claims
`
`1 and 9 each claim an optical physiological sensor that includes, among other
`
`things, (1) a plurality of emitters, (2) at least four detectors, and (3) either a lens
`
`comprising a single outwardly protruding convex surface (claim 1) or a lens
`
`forming a cover of the housing, wherein at least a portion of the lens protrudes
`
`from the housing and the lens comprises a single convex surface (claim 9).
`
`29. Claim 1 requires a lens configured to be located between tissue of the
`
`user and the plurality of detectors, wherein the lens comprises a single outwardly
`
`protruding convex surface. Claim 1 reads:
`
`1. A noninvasive optical physiological sensor comprising:
`
`a plurality of emitters configured to emit light into tissue of a
`
`user;
`
`a plurality of detectors configured to detect light that has been
`
`attenuated by tissue of the user, wherein the plurality of detectors
`
`comprise at least four detectors;
`
`-14-
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`
`
`
`
`a housing configured to house at least the plurality of detectors
`
`in a circular portion of the housing; and
`
`a lens configured to be located between tissue of the user and
`
`the plurality of detectors when the noninvasive optical physiological
`
`sensor is worn by the user, wherein the lens comprises a single
`
`outwardly protruding convex surface configured to cause tissue of the
`
`user to conform to at least a portion of the single outwardly protruding
`
`convex surface when the noninvasive optical physiological sensor is
`
`worn by the user and during operation of the noninvasive optical
`
`physiological sensor.
`
`30. Claim 9 requires a lens forming a cover of the housing, wherein at
`
`least a portion of the lens protrudes from the housing and the lens comprises a
`
`single convex surface. Claim 9 reads:
`
`9. An optical physiological measurement sensor comprising:
`
`a plurality of emitters configured to emit light into tissue of a
`
`user;
`
`a housing including a planar surface;
`
`at least four detectors arranged on the planar surface of the
`
`housing, wherein the four detectors are arranged in a grid pattern; and
`
`-15-
`
`
`
`
`
`a lens forming a cover of the housing, wherein at least a portion
`
`of the lens protrudes from the housing and the lens comprises a single
`
`convex surface.
`
`31. Dr. Kenny applies the same combination of references against claim 1
`
`(Ex. 1003 ¶¶68-93, 125-129, 130-145) and claim 9 (Ex. 1003 ¶¶106-113, 125-129,
`
`160-165). Dr. Kenny’s analysis generally treats claims 1 and 9 similarly, and Dr.
`
`Kenny relies on and incorporates his analysis for claim 1 into his analysis of claim
`
`9. Ex. 1003 ¶¶106, 107, 110, 113, 125, 128, 129, 160-163, 165. In addressing Dr.
`
`Kenny’s opinions, my analysis therefore likewise applies to claims 1 and 9.
`
`V. THE PETITION’S PROPOSED COMBINATIONS
`32. Petitioner presents three grounds. Grounds 1A-1B (the “Aizawa
`
`grounds”) combine at least Aizawa (Ex. 1006) and Inokawa (Ex. 1007, translation
`
`at Ex. 1008). Pet. 2.
`
` Ground 1A combines Aizawa and Inokawa. Ground 1A challenges
`
`claims 1-6, 8-16, 18, and 19.
`
` Ground 1B adds Ohsaki (Ex. 1014) to the combination of Aizawa and
`
`Inokawa. Petitioner characterizes Ohsaki as providing an additional
`
`motivation and rationale to modify Aizawa to add a lens. Pet. 44-45.
`
`Ground 1B challenges claims 1-6, 8-16, 18, and 19.
`
`-16-
`
`
`
`
`
`33. Ground 2 (the “Mendelson ground”) combines Mendelson-1988 (Ex.
`
`1015) and the same Inokawa reference used in Grounds 1A-1B. Pet. 2. Ground 2
`
`challenges claims 1-6, 8-16, 18, and 19.
`
`34. Aizawa and Mendelson-1988 share the same general arrangement of
`
`peripheral detectors positioned radially around a central light source. Ex. 1006
`
`Fig. 1A; Ex. 1015 Figs. 2A-2B. In contrast, Inokawa arranges two LEDs on the
`
`outside edge of its sensor and one detector in the center of the sensor. Ex. 1008
`
`Fig. 2. I understand that Petitioner asserts a person of ordinary skill in the art
`
`would have incorporated Inokawa’s convex lens into Aizawa or Mendelson-1988’s
`
`sensor with the motivation to “increase the light collection efficiency.” Pet. 14,
`
`48-49. As I discuss below, a POSITA would have not incorporated Inokawa’s
`
`convex lens into Aizawa or Mendelson-1988’s sensor with the motivation to
`
`“increase the light collection efficiency” because a POSITA would have
`
`understood that Inokawa’s convex lens would collect incoming light towards the
`
`center of the sensor. Unlike Inokawa, which has its detector in the center, between
`
`an emitter on either side, Aizawa and Mendelson-1988 have detectors placed at the
`
`edge (or periphery) of the sensor. Thus, a POSITA would have believed that
`
`Inokawa’s convex lens, which was designed to concentrate light at the center-
`
`located detector and increase the optical signal, would have the opposite effect
`
`-17-
`
`
`
`
`
`when used with Aizawa or Mendelson-1988’s peripherally located detectors and
`
`would decrease the light collection efficiency of the sensor.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`35. Petitioner asserts a POSITA “would have been a person 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.” Pet. 4. Alternatively, Petitioner asserts a POSITA
`
`could have “a Master of Science degree in a relevant academic discipline with less
`
`than a year of related work experience in the same discipline.” Pet. 4.
`
`36. Dr. Kenny states that he applies the same level of skill in his analysis:
`
`“one of ordinary skill in the art relating to, and at the time of, the invention of the
`
`’191 Patent would have been 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,
`
`-18-
`
`
`
`
`
`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.
`
`37.
`
`I note that Petitioner’s asserted level of skill (1) requires no
`
`coursework, training or experience with optics or optical physiological monitors;
`
`(2) requires no coursework, training or experience in physiology; and (3) focuses
`
`on data processing and not sensor design. In responding to Dr. Kenny’s opinions
`
`in this proceeding, I apply Petitioner’s asserted level of skill.
`
`38.
`
`In addition, as noted above, I understand that Dr. Kenny carried out
`
`his analysis of patentability as of July 2, 2009. Ex. 1003 ¶16. In responding to Dr.
`
`Kenny’s opinions, I also apply the July 2, 2009 date in my analysis. My opinions
`
`would not change if my analysis of patentability were carried out as of July 3,
`
`2008. I do not offer any opinions regarding priority in this declaration.
`
`A.
`
`VII. GROUNDS 1A-1B DO NOT ESTABLISH OBVIOUSNESS
`Introduction To Ground 1A
`39. Ground 1A combines two references: Aizawa and Inokawa.
`
`1.
`
`Aizawa Uses Peripherally Located Detectors Around A Single
`Centrally Located Emitter (LED)
`40. Aizawa discloses a sensor with four periphery-located photodetectors
`
`(22) around a single centrally located LED (21). Ex. 1006 Abstract, Fig. 1A.
`
`-19-
`
`
`
`
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`DETECTOR
`
`LED
`
`DETECTOR
`
`Aizawa Fig. 1B (cross-sectional view, color added)
`
`
`
`Aizawa’s Features
` Green: central emitter
`(21)
` Red: peripheral
`detectors (22)
`
`
`
`
`
`Aizawa Fig. 1A (top-down view, color added)
`
`41. Aizawa uses this configuration of multiple detectors arrayed around a
`
`single LED to ensure at least one detector is near the measurement site, improving
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`measurement consistency. Ex. 1006 ¶[0027]. Aizawa’s sensor is used to detect
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`signals on the inner side of the wrist and Aizawa explains that as long
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