ROBERT T. STONE, Ph.D.
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`SUMMARY
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`Dr. Stone has over thirty years of academic and industry experience in the field of
`medical electronics systems and instrumentation. As Chief Executive Officer and
`founder of Medical Design Solutions, Inc, Dr. Stone is responsible for all phases of
`product development including concept definition, prototyping, design, evaluation,
`patenting and technology licensing. He is an experienced expert witness both as a
`background consultant and testimonial expert.
`
`Expertise
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`Carbon Monoxide Monitoring
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`Doppler Ultrasound
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`Analog Electronics
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`Medical Electronics
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`Portable Vascular Analysis Systems
`Pulse Oximetry Signal Processing
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`Invasive and non-invasive thermometry
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`FDA Product Certification
`Ultrasonic Imaging
`Telemetry (remote monitoring)
`Newborn Hearing Screening Devices
`Pulse Oximetry
`Technology Licensing
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`PROFESSIONAL EXPERIENCE
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`2011 to Present
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`Medical Design Solutions, Inc
`Founder and CEO
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`Responsible for virtually all phases of product development including concept definition,
`prototyping, design, evaluation, patenting, technology licensing, for various products
`directed at various markets.
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`2008 to 2011
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`Responsible for virtually all phases of product development including concept definition,
`prototyping, design, evaluation, patenting, technology licensing, for various products
`directed at various markets.
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`2004 to 2008
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`Tronics MedTech, Inc
`CTO
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`MedTech Development, LLC
`Founder, CTO
`
`Responsible for virtually all phases of product development including concept definition,
`prototyping, design, evaluation, patenting, technology licensing, for various products
`directed at various markets.
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`001
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`Page 2.
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`Robert T. Stone, Ph.D.
`Resume
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`1997 to 2004
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`
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`Pacific Consultants, LLC
`Director of Medical Electronics
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`Responsible for virtually all phases of product development including concept definition,
`prototyping, design, evaluation, patenting, technology licensing, for various products
`directed at various markets.
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`1991 to 1996
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`Natus Medical, Inc.
`Vice President Research & Development, Chief Technical Officer
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`Responsible for all phases of new product development including concept definition,
`prototyping, design, clinical trials, FDA clearance, regulatory compliance including UL,
`CSA, CE listings, patenting and technology licensing for products directed at the
`pediatric hospital market. Responsibilities included contract negotiation, international
`distributor technical support, distributor evaluation and contract negotiations, Federal
`Research Grant proposal and management. Developed and patented broad patents for a
`new concept in breath analysis, covering design, embodiment, and a disposable element.
`Other achievements included:
`
`• Conceived and guided the development of, and maintained the second generation of
`newborn hearing screening devices, a product that was the current backbone of the
`Natus product line. Worked extensively with researchers in refining and defining
`product specifications and performance parameters. Wrote and managed the FDA
`510(k) clearance process during the peak of the FDA logjam in 1993-1994. The
`introduction of this product caused growth in sales to virtually double in the
`marketplace, and was a major factor in the company’s pending profitability.
`
`• Conceived the re-design of the company’s first generation product to incorporate
`some of the major benefits of the second-generation product in a package, which
`allowed major expansion of the product market, both domestically and
`internationally.
`
`•
`
`Invented a device, which can be used to diagnose the most significant contributing
`factor of the most common disorder present in newborns. Developed and obtained
`three patents covering the devices design plus a valuable disposable. Managed early
`clinical validation trials, expanded the concept to other applications, and executed a
`Federal Grant which demonstrated successfully the application of the patent to
`forensic breath alcohol analysis. Current plans to market this device are based upon
`pressing marketplace needs and the potential application in virtually every birthing
`center, pediatric clinic, and emergency in the developed countries.
`
`• Obtained a license from the Medical Research Council of the UK to a new generation
`of auditory screening devices, and developed the technology into a device that is
`generating pressing demands upon the company for launch and distribution.
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`Page 3.
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`Robert T. Stone, Ph.D.
`Resume
`
`
`1989 to 1991
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`MedaSonics, Inc.
`Vice President Engineering
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`1983 to 1989
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`Managed a group of 15 engineers, technicians, designers in the design and development
`of portable vascular analysis equipment designed for clinics, hospitals, and physicians
`offices. Coordinated the development of specifications, project planning, cost analysis
`and resource allocation for multiple simultaneous projects, evaluated new technological
`
`opportunities, negotiated technology licensing and consulting agreements, participated in
`company directors strategic planning. Wrote several patent disclosures. Took over an
`engineering department that was in great disarray, faced with an urgent need for products
`late for a closing market window, and key engineers were leaving in frustration.
`Completed the urgent projects in a timely fashion, helped develop a new direction for the
`corporation, and defined the product lines which could provide the needed growth and
`stability.
`
`Nellcor, Inc.
`Manager, Electronic Research
`
`Performed general research and development of new products in the area of blood gas
`monitoring, oxygen saturation, carbon dioxide gas analysis, and cardiac output. Early
`prototype development, clinical validation, and presentation of results to corporate
`officers for development selection. Wrote several patent disclosures, some of which
`were filed and granted, and some of which were maintained as trade secrets. Contributed
`to several marked advances in pulse Oximetry signal processing (two US patents issued),
`and developed an Oximetry telemetry system. Two of the patents were vital to market
`growth of Pulse Oximetry. One of the patents allowed the positioning of the second-
`generation product in awake, agitated, or ambulatory patients. The second patent
`significantly improved the product performance during physiologic transients, and is
`currently in use in as many as 50% of the pulse Oximeters in the world. The Oximetry
`marketplace expanded from critical care facilities to step down wards and general wards
`with the introduction of the OXINET telemetry system that was a sole contributor
`definition, design, and development
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`1981 to 1983
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`Virginia Polytechnic Institute and State University
`Assistant Professor, Engineering
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`Taught classes in system analysis, instrumentation, thermodynamics, and signal analysis.
`Developed and taught classes in microprocessor applications in instrumentation and
`control. Obtained research funding in analysis of control systems for nuclear reactors.
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`Page 4.
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`Robert T. Stone, Ph.D.
`Resume
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`1979 to 1980
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`1971 to 1979
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`On sabbatical from Virginia Polytechnic Institute as a NSF Fellow at Stanford University
`to earn Ph.D.
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`Virginia Polytechnic Institute and State University
`Nuclear Reactor Supervisor
`
`Managed and maintained a research and teaching reactor which routinely performed
`neutron activation analysis as a research service to university, state, and industry
`laboratories. Scheduled, supervised, and assisted in performing all laboratory functions,
`participated in University Safety Committee and Reactor Safety Committee, directly
`interfaced with the Nuclear Regulatory Commission, assuring compliance with all
`nuclear device regulations, upgraded all reactor controls, shielding, and instrumentation
`to allow five-fold power increase for increased laboratory sensitivity. Performed these
`duties while studying continually for BSEE and MSEE degrees.
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`1965 to 1971
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`United States Navy
`Nuclear Reactor Operator, Electronics Technician & Engineering
`Watch Supervisor
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`Highest rank achieved, Electronics Technician (Nuclear) First Class (E-6) Qualified in
`Officer position as Engineering watch supervisor/Engineering watch officer on the USS
`Bainbridge, DLG-N25. Spent two years as an instructor in nuclear theory and
`instrumentation at Schenectady New York Nuclear Power Prototype facility
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`EDUCATION
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`Ph.D., Electrical Engineering, Stanford University, 1981
`MSEE, with distinction, Virginia Polytechnic Institute and State University, 1979
`BSEE, Virginia Polytechnic Institute and State University, 1977
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`LITIGATION RELATED EXPERIENCE
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`
`
`Type of Matter:
`Law Firm:
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`Case Name:
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`
`Date Filed:
`Services Provided:
`
`Patent Infringement
`Kirkland and Ellis, LLP
`Medtronic Puerto Rico Operations Co. et al v. Animas
`Corporation, 2:12-cv-04471-RSWL-RZ (C.D. Cal.)
`5/22/2012
`Patent Infringement matter involving remotely controlled insulin
`pump. Advised attorneys, interpreted technology, wrote expert
`reports and declarations. Testified at deposition
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`004
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`Resolved by settlement
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`Page 5.
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`Patent Infringement
`Kirkland and Ellis, LLP
`Medtronic Minimed Inc. at al v. Insulet Corporation, 2:12-cv-
`08048-PA-CW (C.D. Cal.)
`9/18/2012
`Patent Infringement matter involving remotely controlled insulin
`pump. Advised attorneys, interpreted technology, wrote expert
`reports and declarations.
`Settled
`
`
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`Robert T. Stone, Ph.D.
`Resume
`
`
`
`Status:
`
`Type of Matter:
`Law Firm:
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`Case Name:
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`Date Filed:
`Services Provided:
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`Status:
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`Type of Matter:
`Law Firm:
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`Case Name:
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`Whistleblower, Fraud
`Scott Bonagofsky, Atty at Law
`United States et al v. Masimo Corporation, 2:10-cv-08169-CJC-
`VBK (C.D. Cal.)
`10/29/2010
`
`Date Filed:
`Services provided: Advised Attorneys, analyzed technology, prepared expert report
`and declaration.
`Resolved
`
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`Patent Infringement
`Foley and Lardner, LLP
`Masimo Corporation v. Mindray DS USA, Inc. et al, 8:12-cv-
`02206-CJC-JPR (C.D. Cal.)
`12/21/2012
`Patent Infringement matter involving frequency domain signal
`processing of biological signals and Oximetry electronics on
`behalf of defendant. Advised attorneys, interpreted technology.
`Ongoing
`
`Patent Infringement
`Mayer Brown LLP
`Masimo Corporation v. Philips Electronics North America
`Corporation et al, 1:09-cv-00080-LPS-MPT (D. Del.)
`2/3/2009
`Patent Infringement matter involving frequency domain signal
`processing of biological signals and Oximetry electronics on
`behalf of defendant. Advised attorneys, interpreted technology,
`wrote expert reports, will likely testify at jury trial. Deposed July
`2012
`Ongoing
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`Status:
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`Type of Matter:
`Law Firm:
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`Case Name:
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`Date Filed:
`Services Provided:
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`Status:
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`Type of Matter:
`Law Firm:
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`Case Name:
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`Date Filed:
`Services Provided:
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`Status:
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`005
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`Page 6.
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`Patent Infringement
`Merchant and Gould, PC
`Robert Bosch Healthcare Systems, Inc. v. CardioCom, LLC, 5:12-
`cv-03864-EJD (N.D. Cal.)
`7/24/2012
`Patent Infringement matter involving remote health monitoring
`systems. Prepared declarations for re-examination of patents.
`Ongoing
`
`Patent Infringement
`Merchant and Gould, PC
`My Health, Inc. et al v. CardioCom, LLC, 13-cv-00136-RSP (E.D.
`Tex.)
`2/15/2013
`Patent Infringement matter involving remote health monitoring
`systems. Prepared declarations for re-examination of patents.
`Settled
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`
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`Robert T. Stone, Ph.D.
`Resume
`
`Type of Matter:
`Law Firm:
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`Case Name:
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`Date Filed:
`Services Provided:
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`Status:
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`Type of Matter:
`Law Firm:
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`Case Name:
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`Date Filed:
`Services Provided:
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`Status:
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`Status:
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`Product Liability/Malpractice
`Type of Matter:
`MacDonald-Devin PC
`Law Firm:
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`Guinn et al v. Nonin Medical, Inc. et al, 3:11-cv-00230 (S.D. Tex.)
`Case Name:
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`5/16/2011
`Date Filed:
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`Services Provided: Opined on performance, design and operation of Pulse Oximeter,
`wrote expert report
`Ongoing
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`PUBLICATIONS
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`HJ Vreman, LM Baxter, RT Stone, and DK Stevenson, “Evaluation of a fully automated
`end-tidal carbon monoxide instrument for breath analysis,” Clin Chem, 1996 42: 50-56.
`
`Robert T. Stone & Howard M. Berlin, “Design of VMOS Circuits with Experiments,”
`Howard W. Sams Publications, 1980.
`
`Robert T. Stone, “An Energy Discriminating Photon Counting Detector for Computed
`Tomography,” Ph.D. thesis, Stanford University, 1981.
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`006
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`Robert T. Stone, Ph.D.
`Resume
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`PATENTS
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`Patent Number
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`Year Issued
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`8,292,800
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`6,694,157
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`6,594,511
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`6,503,207
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`6,480,729
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`6,443,908
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`6,368,289
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`2012
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`2004
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`2003
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`2003
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`2002
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`2002
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`2002
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`Page 7.
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`Title
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`Implantable Pump system
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`Method and Apparatus for Determination of
`pH pCO2, Hemoglobin, and Hemoglobin
`Oxygen Saturation
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`Method and Apparatus for Determining
`Physiological Characteristics
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`Multi-Mode Audiometric Device and
`Associated Screening Method
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`Method for Determining Blood Constituents
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`Method and Apparatus for In Vivo
`Measurement of Carbon Monoxide
`Production Rate
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`Acoustic Coupling Device
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`Acoustic Coupling Device
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`6,368,288
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`D444.237
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`5,913,309
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`5,826,582
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`RE35,122
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`D0354808
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`5,404,885
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`5,357,971
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`5,293,875
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`2002
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`2001
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`1999
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`1998
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`1995
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`1995
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`1995
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`1994
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`1994
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`Ear Coupler
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`Disposable Element for Use with a Hearing
`Screener
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`Ear Phone Assembly for Use with a Hearing
`Screener
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`Method and Apparatus for Detecting Optical
`Pulses
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`End-Tidal Carbon Monoxide Monitor Filter
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`Filter Unit for End-Tidal Carbon Monoxide
`Monitor
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`Filter Unit for End Tidal Carbon Monoxide
`Monitor
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`In-Vivo Measurement of End-Tidal Carbon
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`007
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`Page 8.
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`Monoxide Concentration Apparatus and
`Methods
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`Method and Apparatus for Calculating
`Arterial Oxygen Saturation Based
`Plethysmographs Including Transients
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`Method and Apparatus for Detecting Optical
`Pulses
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`Method and Apparatus for Detecting Optical
`Pulses
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`Method and Apparatus for Calculating
`Arterial Oxygen Saturation
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`Method and Apparatus for Calculating
`Arterial Oxygen Saturation
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`
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`Robert T. Stone, Ph.D.
`Resume
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`5,078,136
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`4,934,372
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`4,911,167
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`4,869,254
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`4,869,254
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`1992
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`1990
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`1990
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`1989
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`1989
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`Published Applications
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`
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`PUB. APP.
`Title
`NO.
`1 20110288436 Materials and methods for insulating electronic components and services
`2 20110160609 Method and system for monitoring pressure in a body cavity
`3 20110160560
`Pressure sensor apparatus, system and method
`4 20110144587 Liquid agent delivery apparatus, system and method
`5 20090312785
`Implantable Pump System
`6 20080275525 Method and system for regulating respiration by means of simulated action
`potential signals
`7 20080161875 Gastric restriction method and system for treatment of eating disorders
`8 20060287679 Method and system to control respiration by means of confounding neuro-
`electrical signals
`9 20060173508 Method and system for treatment of eating disorders by means of neuro-
`electrical coded signals
`10 20060111755 Method and system to control respiration by means of neuro-electrical coded
`signals
`11 20060064137 Method and system to control respiration by means of simulated action
`potential signals
`12 20030208196 Control system for limited-use device
`13 20010049477 Method and apparatus for in vivo measurement of carbon monoxide
`production rate
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`008
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`Page 9.
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`Robert T. Stone, Ph.D.
`Resume
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`14 20010037059 Method and apparatus for determining physiological characteristics
`15 20010037058 Method for determining blood constituents
`16 20010036277 Audiometric apparatus and associated screening method
`17 20010034494 Acoustic coupling device
`18 20010034493 Multi-mode audiometric device and associated screening method
`19 20010034492 Acoustic coupling device
`20 20010033220
`Security control method and system
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`PROFESSIONAL AFFILIATIONS & AWARDS
`
`
`Member, Campbell Church of Christ
` Elder for a Congregation of approximately 450 members
`Member IEEE
`Inactive member, SPIE
`Inactive member American Nuclear Society
`National Science Foundation Fellow
`Student member of Phi Kappa Phi, Eta Kappa Nu and Tau Beta Phi Honor Societies
`
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`009