UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.
`
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`
`Patent Owner.
`
`Case IPR2020-01714
`U.S. Patent 10,631,765
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`Masimo Ex. 2004
`Apple v. Masimo
`IPR2020-01714
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APPLE INC.
`
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`
`Patent Owner.
`
`Case IPR2020-01714
`U.S. Patent 10,631,765
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`Masimo Ex. 2004
`Apple v. Masimo
`IPR2020-01714
`
`
`
`
`
`
`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..............................................................................12
`
`Obviousness .........................................................................................12
`
`IV.
`
`INTRODUCTION TO MASIMO’S ’765 PATENT .....................................14
`
`A.
`
`B.
`
`The ’765 Patent ...................................................................................14
`
`Introduction To The Independent Claims Of The ’765
`Patent ...................................................................................................15
`
`V.
`
`THE PETITION’S PROPOSED COMBINATION ......................................18
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART ...........................................18
`
`VII. GROUND 1 DOES NOT ESTABLISH OBVIOUSNESS ...........................19
`
`A.
`
`Introduction To Ground 1 ...................................................................19
`
`1.
`
`Ohsaki Discloses A Pulse Rate Sensor With A
`Single Emitter And A Single Detector That
`Must Be Arranged Linearly On The Back Side
`Of The Wrist .............................................................................20
`
`2.
`
`The Shape Of Ohsaki’s Board ..................................................21
`
`3. Mendelson ’799 Discloses A Circular Oxygen
`Saturation Sensor ......................................................................24
`
`4.
`
`Petitioner’s Proposed Combination Of Ohsaki
`And Mendelson ’799 .................................................................25
`
`
`-i-
`
`
`
`
`
`5.
`
`6.
`
`7.
`
`Petitioner’s Proposed Motivation To Combine
`Ohsaki And Mendelson ’799 ....................................................29
`
`Petitioner’s Proposed Addition Of A Third
`Reference—Schulz....................................................................30
`
`Petitioner’s Proposed Addition Of A Fourth
`Reference—Mendelson 2006 ....................................................31
`
`B.
`
`A POSITA Would Have Understood That Ohsaki’s
`Rectangular Board Does Not Work With Mendelson
`’799’s Radially Symmetric Circular Sensor
`Arrangement ........................................................................................32
`
`1.
`
`2.
`
`A POSITA Would Have Believed That
`Modifying Ohsaki’s Rectangular Board Would
`Eliminate The Advantages Ohsaki Teaches .............................32
`
`A POSITA Would Not Have Been Motivated
`To Add A Rectangular Board To Mendelson
`’799’s Circular Sensor ..............................................................39
`
`C.
`
`A POSITA Would Have Understood That Ohsaki’s
`Required Measurement Location Would Result In
`Weak Signals For Mendelson ’799’s Oxygen
`Saturation Measurements ....................................................................44
`
`D. A POSITA Would Not Have Been Motivated To
`Adversely Impact The Optical Signal By Adding A
`Convex Lens To Mendelson ’799’s Sensor ........................................49
`
`1.
`
`2.
`
`3.
`
`A POSITA Would Have Understood That A
`Convex Cover Directs Light To The Center Of
`The Sensor And Away From The Periphery ............................50
`
`A POSITA Would Have Sought To Avoid The
`Air Gaps Introduced By Ohsaki’s Rectangular
`Board .........................................................................................53
`
`A POSITA Would Not Have Selected A
`Convex Cover To Protect The Optical Elements .....................55
`
`
`-ii-
`
`
`
`
`
`E.
`
`A POSITA Would Not Have Decreased Signal
`Strength By Adding A Window Taught By Schulz ............................57
`
`F. Mendelson 2006, The Fourth Reference In The
`Combination, Further Undermines The Combination
`Of Ohsaki, Mendelson ’799, and Schulz ............................................65
`
`G. Dr. Kenny Does Not Provide Evidence Of An
`Expectation Of Success .......................................................................68
`
`H.
`
`The Challenged Dependent Claims In Ground 1 ................................69
`
`1.
`
`2.
`
`3.
`
`The Challenged Dependent Claims Are Not
`Obvious For The Same Reasons As The
`Independent Claims...................................................................69
`
`Claims 7 and 26.........................................................................69
`
`Claim 29 ....................................................................................72
`
`VIII. GROUND 2 FAILS FOR AT LEAST THE SAME
`REASONS AS GROUND 1 ..........................................................................75
`
`IX. GROUND 3 FAILS FOR AT LEAST THE SAME
`REASONS AS GROUND 1 ..........................................................................76
`
`X. GROUND 4 FAILS FOR AT LEAST THE SAME
`REASONS AS GROUND 1 ..........................................................................76
`
`XI. OATH ............................................................................................................78
`
`
`
`
`
`
`
`-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 1-29 of U.S. Patent No. 10,631,765 (“the ’765 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
`
`Description
`
`1001 U.S. Patent No. 10,631,765 (“’765 Patent”)
`1002
`File History for the ’765 Patent
`1003 Declaration of Dr. Thomas W. Kenny
`1004 Curriculum Vitae of Dr. Thomas W. Kenny
`1005 Masimo Corporation, et al. v. Apple Inc., Complaint, Civil Action No.
`8:20-cv-00048 (C.D. Cal.)
`1006 U.S. Pub. No. 2002/0188210 (“Aizawa”)
`1007
`JP 2006-296564 (“Inokawa”)
`1008 Certified English Translation of Inokawa and Translator’s Declaration
`1009 U.S. Pub. No. 2001/0056243 (“Ohsaki”)
`1010
`“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”)
`1011 U.S. Pub. No. 2007/0093786 (“Goldsmith”)
`1012 U.S. Pat. No. 6,801,799 (“Mendelson ’799”)
`1013 U.S. Pub. No. 2004/0054291 (“Schulz”)
`1016 U.S. Pat. No. 3,789,601 (“Bergey”)
`
`-8-
`
`
`
`
`
`Exhibit
`
`Description
`
`1017
`
`1018
`
`“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”)
`“Skin Reflectance Pulse Oximetry: In Vivo Measurements from the
`Forearm and Calf,” Y. Mendelson, et al.; Journal of Clinical Monitoring,
`vol. 7, No. 1, January 1991 (“Mendelson 1991”)
`1019 Excerpts from Design of Pulse Oximeters, J.G. Webster; Institution of
`Physics Publishing, 1997 (“Webster”)
`1020 QuickSpecs; HP iPAQ Pocket PC h4150 Series
`1021 Excerpts from How to Do Everything with Windows Mobile, Frank
`McPherson; McGraw Hill, 2006 (“McPherson”)
`1022 Excerpts from Master Visually Windows Mobile 2003, Bill Landon, et
`al.; Wiley Publishing, Inc., 2004 (“Landon”)
`“Stimulating Student Learning with a Novel ‘In-House’ Pulse Oximeter
`Design,” J. Yao and S. Warren; Proceedings of the 2005 American
`Society for Engineering Education Annual Conference & Exposition,
`2005 (“Yao”)
`1024 U.S. Pub. No. 2008/0194932 (“Ayers”)
`1025 U.S. Pat. No. 7,031,728 (“Beyer”)
`1026 U.S. Pub. No. 2007/0145255 (“Nishikawa”)
`1027 National Instruments LabVIEW User Manual
`“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”)
`2008 Deposition Transcript of Dr. Thomas W. Kenny in Apple Inc. v. Masimo
`Corp., IPR2020-01536, IPR2020-01538 (April 24, 2021)
`2009 Deposition Transcript of Dr. Thomas W. Kenny in Apple Inc. v. Masimo
`Corp., IPR2020-01536, IPR2020-01538 (April 25, 2021)
`
`1023
`
`2003
`
`-9-
`
`
`
`
`
`Exhibit
`
`Description
`
`2010
`
`2015
`
`2017
`
`Frank H. Netter, M.D., Section VI Upper Limb, Atlas of Human
`Anatomy (2003), Third Edition (“Netter”)
`“Reflectance-Based Pulse Oximeter For The Chest And Wrist,” A.
`Fontaine, et al., A Major Qualifying Project Report: Submitted to the
`Faculty of the Worcester Polytechnic Institute, submission date April 24,
`2013 (“Fontaine”)
`“Measurement Site and Applied Pressure Consideration in Wrist
`Photoplethysmography,” E. Geun, et al., The 23rd International
`Technical Conference
`on Circuits/Systems, Computers
`and
`Communications (ITC-CSCC 2008), pp. 1129-1132 (“Geun”)
`“Reflectance Pulse Oximetry: Practical Issues And Limitations,” H. Lee,
`et al., ICT Express 2 (2016), pp. 195-198 (“Lee”)
`Petition for Inter Partes Review IPR2020-01520
`Declaration of Dr. Thomas W. Kenny in Apple Inc. v. Masimo Corp.,
`IPR2020-01520
`2021 U.S. Pat. No. 6,157,850 (“Diab”)
`Paper 2 Petition for Inter Partes Review IPR2020-01714
`Paper 8 Decision Granting Institution of Inter Partes Review IPR2020-01714
`
`
`2018
`
`2019
`
`2020
`
`III. UNDERSTANDING OF PATENT LAW
`
`18.
`
`I am not an attorney and will not be offering legal conclusions.
`
`However, I have been informed of several principles concerning the legal issues
`
`relevant to analyzing the challenges to the claims of the ’765 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
`
`-10-
`
`
`
`
`
`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. 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.
`
`-11-
`
`
`
`
`
`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 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.
`
`-12-
`
`
`
`
`
`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.
`
`26.
`
`I understand that Dr. Kenny carried out his analysis of patentability as
`
`of July 3, 2008. Ex. 1003 ¶¶16, 23. I likewise carry out my analysis of
`
`patentability as of July 3, 2008. I do not offer any opinions regarding priority in
`
`this declaration.
`
`-13-
`
`
`
`
`
`IV.
`
`INTRODUCTION TO MASIMO’S ’765 PATENT
`
`A. The ’765 Patent
`
`27. Masimo’s U.S. Patent No. 10,631,765 (“’765 Patent”) is generally
`
`directed to optical physiological sensor devices that use a combination of different
`
`design elements and improve optical detection efficiency. Masimo’s claims are
`
`directed to physiological measurement systems that include physiological sensor
`
`devices. These claims include at least four detectors, one or more emitters, and a
`
`cover with a protruding convex surface that works in conjunction with a wall to
`
`enhance the device’s effectiveness. The ’765 Patent explains that these different
`
`pieces work together to provide greater noise cancellation and an order of
`
`magnitude increase in signal strength. Ex. 1001 9:18-23, 20:14-30; see also 3:13-
`
`23, 4:16-27. For example, the ’765 Patent helps address issues related to light
`
`attenuation and errors resulting from the variations in the path of light passing
`
`through tissue. The ’765 Patent identifies several different benefits to the use of a
`
`protrusion in conjunction with the physiological sensor device. For instance, the
`
`protrusion thins out a measurement site on the body, resulting in less light
`
`attenuation by a measured tissue for the physiological sensor device. Ex. 1001
`
`7:46-51. The protrusion also further increases the area from which attenuated light
`
`can be measured. Ex. 1001 7:51-53. The wall or housing may also play a role by
`
`allowing maximization of the amount of tissue-attenuated light that impinges on the
`
`-14-
`
`
`
`
`
`detectors. Ex. 1001 36:35-41. Windows can provide benefits including directing
`
`light from the measurement site to the photodetectors. See, e.g., Ex. 1001 19:28-38.
`
`The multiple detectors in the physiological sensor device of the ’765 Patent allow
`
`for an averaging of measurements, and the averaging of measurements can reduce
`
`errors due to variations in the path of light passing through the tissue. Ex. 1001
`
`9:18-23; see also 3:13-23, 4:16-27.
`
`B.
`
`Introduction To The Independent Claims Of The ’765 Patent
`
`28.
`
`The ’765 Patent has two independent claims: claims 1 and 21. Claim
`
`1 reads as follows:
`
`A physiological measurement system comprising:
`
`a physiological sensor device comprising:
`
`one or more emitters configured to emit light into tissue of a
`
`user;
`
`at least four detectors, wherein each of the at least four
`
`detectors has a corresponding window that allows light to pass
`
`through to the detector;
`
`a wall that surrounds at least the at least four detectors; and
`
`a cover comprising a protruding convex surface, wherein the
`
`protruding convex surface is above all of the at least four detectors,
`
`-15-
`
`
`
`
`
`wherein at least a portion of the protruding convex surface is rigid,
`
`and wherein the cover operably connects to the wall; and
`
`a handheld computing device in wireless communication with the
`
`physiological sensor device, wherein the handheld computing device
`
`comprises:
`
`one or more processors configured to wirelessly receive one or
`
`more signals from the physiological sensor device, the one or more
`
`signals responsive to at least a physiological parameter of the user;
`
`a touch-screen display configured to provide a user interface,
`
`wherein:
`
`the user interface is configured to display indicia
`
`responsive to measurements of the physiological parameter, and
`
`an orientation of the user interface is configurable
`
`responsive to a user input; and
`
`a storage device configured to at least temporarily store at least the
`
`measurements of the physiological parameter.
`
`29.
`
`Claim 21 reads as follows:
`
`A physiological measurement system comprising:
`
`a physiological sensor device comprising:
`
`-16-
`
`
`
`
`
`user;
`
`one or more emitters configured to emit light into tissue of a
`
`at least four detectors, wherein each of the at least four
`
`detectors has a corresponding window that allows light to pass
`
`through to the detector;
`
`a wall that surrounds at least the at least four detectors; and
`
`a cover comprising a protruding convex surface, wherein the
`
`protruding convex surface is positioned such that the protruding
`
`convex surface is located between tissue of the user and all of the at
`
`least four detectors when the physiological sensor device is worn by
`
`the user, wherein at least a portion of the protruding convex surface is
`
`rigid, and wherein the cover operably connects to the wall; and
`
`a handheld computing device in wireless communication with the
`
`physiological sensor device.
`
`30. Dr. Kenny applies the same combination of references against claim 1
`
`(Ex. 1003 ¶¶118-168) and claim 21 (Ex. 1003 ¶¶206-212). Dr. Kenny’s analysis
`
`generally treats claims 1 and 21 similarly, and Dr. Kenny relies on and refers back
`
`to his analysis for claim 1 for his analysis of claim 21. Ex. 1003 ¶¶206-212. In
`
`addressing Dr. Kenny’s opinions, my analysis therefore likewise applies to claims 1
`
`and 21.
`
`-17-
`
`
`
`
`
`V. THE PETITION’S PROPOSED COMBINATION
`
`31. Ground 1 challenges claims 1-8, 10-13, 15-16, and 20-29 and
`
`combines Mendelson ’799 (Ex. 1012), Ohsaki (Ex. 1009), Schulz (Ex. 1013), and
`
`Mendelson 2006 (Ex. 1010). Pet. 10-11. Ground 2, which challenges claim 9, adds
`
`Bergey (Ex. 1016). Pet. 88. Ground 3, which challenges claim 14, adds Goldsmith
`
`(Ex. 1011). Pet. 91. Ground 4, which challenges claims 17-19, adds Aizawa (Ex.
`
`1006). Pet. 94.
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART
`
`32.
`
`Petitioner asserts that 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. 9. 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. 9.
`
`33. Dr. Kenny states that he applies the same level of skill in his analysis
`
`stating that a POSITA “would have been someone with a working knowledge of
`
`physiological monitoring technologies. The person would have had a Bachelor of
`
`-18-
`
`
`
`
`
`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.
`
`34.
`
`I note that the 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 Dr. Kenny’s and Petitioner’s asserted level of skill.
`
`35.
`
`In addition, as noted above, I understand that Dr. Kenny carried out
`
`his analysis of patentability as of July 3, 2008. Ex. 1003 ¶¶16, 23. In responding to
`
`Dr. Kenny’s opinions, I also apply the July 3, 2008 date in my analysis. I do not
`
`offer any opinions regarding priority in this declaration.
`
`VII. GROUND 1 DOES NOT ESTABLISH OBVIOUSNESS
`
`A.
`
`Introduction To Ground 1
`
`36. Dr. Kenny’s combination for Ground 1 combines four references:
`
`Ohsaki, Mendelson ’799, Schulz, and Mendelson 2006. Ex. 1003 ¶¶89-224.
`
`-19-
`
`
`
`
`
`1. Ohsaki Discloses A Pulse Rate Sensor With A Single Emitter And
`A Single Detector That Must Be Arranged Linearly On The Back
`Side Of The Wrist
`
`37. Ohsaki is directed to a pulse rate sensor with a single emitter
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