UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Thermo Fisher Scientific Inc
`
`Petitioner
`
`V
`
`BioRad Laboratories Inc
`Patent Owner
`
`IPR201700054
`US Patent No 8236504
`
`Exhibit 2001
`
`DECLARATION OF DEAN P NEIKIRK PHD IN SUPPORT OF
`PATENT OWNERS RESPONSE TO PETITION
`FOR INTER PARTES REVIEW
`
`BioRad Exhibit 2001
`IPR201700054
`Page 1 of 49
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Thermo Fisher Scientific Inc
`
`Petitioner
`
`V
`
`BioRad Laboratories Inc
`Patent Owner
`
`IPR201700054
`US Patent No 8236504
`
`Exhibit 2001
`
`DECLARATION OF DEAN P NEIKIRK PHD IN SUPPORT OF
`PATENT OWNERS RESPONSE TO PETITION
`FOR INTER PARTES REVIEW
`
`BioRad Exhibit 2001
`IPR201700054
`Page 1 of 49
`
`
`
`INTRODUCTION1A Engagement1B
`Patents Awarded3D
`Other Awards5E
`Industry Experience8G Professional Society Involvement9H
`Background And Qualifications2C
`Research And Teaching Experience6F
`PATENT PRINCIPLES11
`Basis Of My Opinions And Materials Considered9
`PROPOSED CLAIM CONSTRUCTION13
`Heating Element And Heater14
`Sample Wells29
`The Specification Of The 504 Patent17
`The Plain Language Of The 504 Patent Claims14
`IV TFS INVALIDITY GROUNDS FAIL33
`The Prosecution History Of The 504 Patent20
`Portions373
`TFS Proposed Construction Is Incorrect21
`TFS Anticipation Ground Fails33
`Heating Element And Heater34
`TFS Obviousness Grounds Fail39
`Li And Miller46
`Li And Heffelfinger45
`Kordunsky Is Not Relevant Prior Art39
`Li Does Not Render Any Claims Obvious39
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`Plurality Of Openings And Plurality Of Transparent
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`TABLE OF CONTENTS
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`Page
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`I
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`II
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`III
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`A
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`B
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`A
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`B
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`1
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`2
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`3
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`4
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`1
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`2
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`1
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`2
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`3
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`BioRad Exhibit 2001
`I PR201700054
`Page 2 of 49
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`
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`Declaration of Dean P Neikirk PhD
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`I Dean P Neikirk PhD hereby declare
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`I
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`INTRODUCTION
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`Case IPR201700054 for
`US Patent No 8236504
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`1
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`I am over the age of twenty one 21 and am competent to make this
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`Declaration
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`I reside at 6604 Aubumhill St Austin TX 78723
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`2
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`I am an independent consultant in technologies related to among
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`other things sensor systems including those used for biochemical sensing
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`3
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`I understand that the Patent Trial and Appeal Board has granted
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`Thermo Fisher Scientific Incs TFS petition to institute the above captioned inter
`partes review IPR of claims 13 611 1317 and 1922 of United States Patent
`
`No 8236504 the 504 patent
`A
`
`Engagement
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`4
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`I have been retained by counsel for BioRad Laboratories Inc
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`BioRad in the above captioned IPR matter as an independent technical expert
`through the agency Teklicon Inc 96 N 3rd Street Suite 301 San Jose
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`CA 95112
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`5
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`As part of this engagement
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`I have been retained to review and
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`evaluate specific claims of the 504 patent
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`In particular I have been asked to
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`provide my opinion regarding the meaning of certain claim terms as well as
`in the art POSA in the subject matter of the
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`whether a person of ordinary skill
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`claims would find them anticipated or obvious over certain publications I expect
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`1
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`BioRad Exhibit 2001
`I PR201700054
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`to testify regarding the matters set forth in this declaration if asked to do so
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`6
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`I am being compensated on an hourly basis for my work performed in
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`connection with this case I have received no additional compensation for my
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`work in this case and my compensation does not depend upon the contents of this
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`report any testimony I may provide or the ultimate outcome of the case
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`B
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`7
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`Background And Qualifications
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`I received a Bachelor of Science degree from Oklahoma State
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`University in physics and mathematics in 1979
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`8
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`Following my undergraduate studies I attended the California
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`Institute of Technology where I earned a Masters degree and Doctorate degree in
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`applied physics in 1981 and 1984 respectively
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`9
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`Each of my academic degrees involved significant studies in sensors
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`optical systems solid state physics semiconductor devices electrical engineering
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`electronic systems electromagnetics radio frequency systems and antennas For
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`example courses relating to these fields that I took include two years of study in
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`electromagnetics and optics one year of study in solid state and semiconductor
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`physics as well as four years of graduate research in electronic devices antenna
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`design antenna fabrication and optical systems My PhD thesis was on the
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`design and fabrication of high frequency electromagnetic detectors and quasi
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`optical
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`imaging antenna arrays including research on integrated circuit fabrication
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`2
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`I PR201700054
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`antennas sensors and packaging I designed and fabricated the first monolithic
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`integrated circuit imaging antenna array for use at wavelengths in the far infrared
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`sometimes referred to as the terahertz region of the electromagnetic spectrum
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`For this work on the first high resolution focal plane array for use at wavelengths
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`between 01 mm and 1 mm I was awarded the 1984 Marconi
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`International
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`Fellowship Young Scientist Award for contributions to the development of
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`millimeter wave integrated circuits especially in the area of detectors and imaging
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`arrays
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`C Patents Awarded
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`10
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`Through my work on sensors electronic systems and innovations in
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`other related fields I have been named an inventor on 17 US patents These are
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`summarized in my curriculum vitae Ex 2002
`11 My issued patents include for example US Patent No 5408107
`
`titled Semiconductor Device Apparatus Having Multiple Current Voltage Curves
`
`and Zero Bias Memory This patent
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`is directed to a semiconductor device that
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`can be switched between current voltage curve settings at higher positive or
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`negative voltages and can be read at lower voltages As another example US
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`Patent No 9291586 titled Passive Wireless SelfResonant Sensor relates to a
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`sensor for detecting materials including a substrate a passivation layer formed on
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`the substrate a high surface area material disposed on the passivation layer and a
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`3
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`selfresonant structure that includes a planar spiral
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`inductor and a plurality of
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`planar interdigitated capacitor electrodes disposed within the passivation layer
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`12
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`Many of my patents are related to sensor arrays used for chemical
`testing These include for example US Patent
`
`testing including biomedical
`
`6589779 General signaling protocol
`
`for chemical receptors in immobilized
`
`matrices US Patent 6602702 Detection system based on an analyte reactive
`
`particle US Patent 7316899 Portable sensor array system and US Patent
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`8105849 Integration of fluids and reagents into selfcontained cartridges
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`containing sensor elements These patents resulted from research by my group
`
`and my collaborators into new sensor arrays with the capability to use optical
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`effects in multiwell platforms to perform multianalyte chemical analysis Early
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`work in that area is discussed in one of my publications Solution Based Analysis
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`of Multiple Analytes by a Sensor Array Toward the Development of an
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`Electronic Tongue Journal of the American Chemical Society vol 120 July
`1998 pp 64296430 authored by John J Lavigne Steve Savoy Marvin B
`Clevenger Jason E Richie Bridget McDoniel SeungJin Yoo Eric V Anslyn
`
`John T McDevitt Jason B Shear and Dean Neikirk This sensor array
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`technology has also been used for DNA analysis as discussed in the publication
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`DNA hybridization and discrimination of single nucleotide mismatches using
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`chip based microbead arrays Analytical Chemistry v 75 n 18 Sep 15 2003
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`4
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`p 47324739 authored by Mehnaaz Ali Romy Kirby Adrian Goodey Marc
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`Rodriguez Andrew Ellington Dean Neikirk and John McDevitt
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`13
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`Two companies have been founded based on technology developed
`
`and patented by my research group and collaborators in the area of chemical
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`sensing arrays In both cases the technology was developed at The University of
`
`Texas at Austin and licensed to startups In one case LabNow Inc received
`
`$14 million in first round venture investment for its point of care diagnostic
`
`system from the Soros Group Austin Ventures and other investors to develop the
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`companys technology and to launch its initial product CD4NowTM a
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`point ofcare diagnostic tool for HIVAIDS patients
`D
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`Other Awards
`
`14 My work as a professor of electrical engineering and my scholarship
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`in various fields relating to sensors and electronic systems have been recognized
`
`through several awards I have received over the years As noted in my curriculum
`
`vitae Ex 2002 these include the Marconi
`
`International Fellowship Young
`
`Scientist Award the Engineering Foundation Faculty Award from the University
`
`of Texas at Austin the General Motors Foundation Centennial Teaching
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`Fellowship the IBM Corporation Faculty Development Award the National
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`Science Foundation Presidential Young Investigator the Lockheed Martin
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`5
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`Aeronautics Company Award for Excellence in Engineering Teaching and various
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`other academic awards
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`E
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`Research And Teaching Experience
`
`15 My work as a professor began in 1984 when I joined the University
`
`of Texas at Austin as an assistant professor
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`In 1988 I became an associate
`
`professor and in 1992 became a full professor Today I continue to be a full
`
`professor at the University of Texas
`
`16
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`Over the years I have taught a variety of electrical engineering
`
`courses at the University These include Integrated Circuit Fabrication VLSI
`
`Fabrication Techniques Ultra Large Scale Integrated Circuit Fabrication
`
`Techniques Integrated Circuit Nanomanufacturing
`
`Techniques Electromagnetics
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`in Packaging Simulation Methods in CADVLSI Micro Electromechanical
`
`Systems Electromagnetic Engineering and Microwave and Radio Frequency
`
`Engineering I have also taught several continuing education courses in these
`
`fields
`
`17
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`I currently conduct
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`research with students and research scientists in
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`the Microelectromagnetics Research Group in the Microelectronics Research
`
`Center at The University of Texas at Austin My research areas include the
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`fabrication and modeling of electromagnetic micro machined sensors and
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`actuators I am also involved in research relating to integrated circuit processing
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`6
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`I PR201700054
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
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`and the high frequency properties of transmission lines Over the years I
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`conducted research in the area of wireless sensors for identifying failing bridges
`
`and improving the safety of new bridges I have also conducted research in the
`
`areas of electromagnetics and acoustics manufacturing systems engineering and
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`solidstate electronics
`
`18
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`For over ten years I served as the Graduate Advisor of the Department
`
`of Electrical and Computer Engineering at the University of Texas at Austin as
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`well as serving for over five years as an Associate Chairman of the Electrical and
`
`Computer Engineering Department at The University of Texas at Austin In
`
`addition to my current position as a professor in the Electrical and Computer
`
`Engineering Department at The University of Texas at Austin I am also an
`
`Associate Dean of Graduate Studies at The University of Texas at Austin
`
`19
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`I have also devoted a significant portion of my time at the University
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`to contributing to various technical journals and other publications My work has
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`been included in 92 referenced archival journal publications 165 referenced
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`conference proceedings and 24 published abstracts I have also contributed to
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`book chapters and technical reports relating to various electrical engineering
`
`topics My publications have addressed technologies such as chemical sensors
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`integrated circuits for antenna arrays determining conductor
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`loss in transmission
`
`lines devices for farinfrared detection multilayer interconnection lines for high
`
`7
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`BioRad Exhibit 2001
`I PR201700054
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
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`speed digital
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`integrated circuits RF oscillator circuits memoryswitching
`
`double barrier quantum well diodes circuits RF and infrared detection circuits
`
`and other topics related to sensors and optical systems
`
`20
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`More information on my research and teaching experience and my
`
`contribution to technical publications is included in my curriculum vitae
`
`Ex 2002
`
`F
`
`Industry Experience
`
`21 While the majority of my professional experience in electrical
`
`engineering has involved research and teaching I have also provided technical
`
`consulting to numerous companies and been involved in academic industry
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`partnerships For example I have provided consulting to Teltech Resource
`
`Network Ardex Inc EP Hamilton Associates Burnett Company
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`Microelectronics
`
`and Computer Technology Corporation and Baker Hughes
`
`In
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`addition my work on electrochemical
`
`sensors was selected as a
`
`commercialization venture between the University of Texas and LabNow Inc
`
`Further my work together with a graduate student relating to actuator stacked
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`microbolometer arrays for multispectral infrared detection was selected for
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`sponsorship by Coventor Inc a company that provides software tools for
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`developing microelectromechanical systems microfluidics and semiconductor
`
`process applications
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`8
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`BioRad Exhibit 2001
`IPR201700054
`Page 10 of 49
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`G Professional Society Involvement
`
`22
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`I have been a Senior Member of the Institute of Electrical and
`
`Electronics Engineers IEEE for more than fifteen years From March 1991 to
`
`October 1994 I served as an Associate Editor for the IEEE publication called
`
`IEEE Transactions on Education I also served as a member of the Editorial
`
`Board on the IEEE Transactions on Microwave Theory and Techniques
`
`in the
`
`19902000 timeframe
`
`23
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`A detailed description of my professional qualifications including a
`
`listing of my specialtiesexpertise and professional activities is contained in my
`
`curriculum vitae Ex 2002
`H
`
`Basis of My Opinions and Materials Considered
`
`24
`
`In forming my opinions I have relied upon my education knowledge
`
`and experience with chemical sensor systems and components that can be used in
`
`devices capable of performing realtime PCR I also have relied upon my
`
`education knowledge and experience with optical design electronic design and
`
`thermal cycling as they relate to realtime PCR in general
`
`25
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`For this work I reviewed and considered the following materials
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`the 504 patent Ex 1001 including its specification and claims
`
`9
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`BioRad Exhibit 2001
`IPR201700054
`Page 11 of 49
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`the prosecution history of US Patent Application No 12827521
`
`the 521 application ie the prosecution history of the 504 patent
`
`Ex 1004
`
`International Patent Application Publication No WO 2004104547
`
`Kordunsky Ex 1009 which is the publication of the
`
`international patent application in BioRads 504 patent family
`
`the Petition for Inter Partes Review of the 504 patent
`
`filed by TFS on
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`October 14 2016 the Petition
`
`the Declaration of Richard Mathies PhD the Mathies
`
`Declaration Ex 1002 that accompanied the Petition
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`a translation of Chinese Patent Application Publication
`
`No CN 1379236A Li Ex 1006 relied on in Grounds 35 of the
`
`Petition
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`US Patent No 6043506 Heffelfinger Ex 1015 relied on in
`
`Ground 4 of the Petition
`
`US Patent No 5528050 Miller Ex 1029 relied on in
`
`Ground 5 of the Petition
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`BioRads Preliminary Response to the Petition filed January 19
`2017 Paper No 7
`
`10
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`BioRad Exhibit 2001
`IPR201700054
`Page 12 of 49
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`the Patent Trial and Appeal Boards decision to institute Inter Partes
`Review of the 504 patent the Board Decision Paper No 8
`
`entered March 17 2017 and
`
`the transcript of the May 24 2017 deposition of Dr Mathies
`Mathies Tr Ex 2003
`
`II
`
`PATENT PRINCIPLES
`
`26
`
`I am a professor of engineering by trade and the opinions I express in
`
`this declaration involve the application of my engineering knowledge and
`
`experience to the evaluation of the claims of the 504 patent and the impact of
`
`certain prior art on the 504 patent
`
`I am not a lawyer and have not been trained in
`
`the law of patents Therefore I have requested the attorneys from Jones Day who
`
`represent BioRad to provide me with guidance as to the applicable patent
`
`law in
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`this matter The paragraphs below express my understanding of how I must apply
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`current legal principles related to patent claim construction and validity to my
`
`analysis
`
`27
`
`It
`
`is my understanding that when interpreting the claims of the
`
`504 patent
`
`I must do so from the perspective of one of ordinary skill
`
`in the art at
`
`the relevant priority date My understanding is that the earliest claimed priority
`
`date of the 504 patent
`
`is May 8 2003 I generally agree with the characterization
`
`of a POSA in the field of the 504 patent
`
`that is set forth in paragraph 14 of the
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`11
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`BioRad Exhibit 2001
`IPR201700054
`Page 13 of 49
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`
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`Declaration of Dean P Neikirk PhD
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`Mathies Declaration Ex 1002
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`Case IPR201700054 for
`US Patent No 8236504
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`28
`
`It
`
`is my understanding that in determining whether a patent claim
`
`under post grant review before the United States Patent and Trademark Office
`
`PTO is anticipated or obvious in view of prior art the PTO must construe the
`
`claim by giving the claim its broadest
`
`reasonable interpretation consistent with the
`
`specification as the claim terms and specification would be understood by a POSA
`
`It is my understanding that
`
`the broadest
`
`reasonable interpretation is the plain
`
`meaning ie the ordinary and customary meaning given to the term by a POSA at
`
`the time of the invention taking into account whatever guidance may be provided
`
`by the specification of the patent
`
`It also is my understanding that the prosecution
`
`history of a patent can be used as guidance when construing claims
`
`29
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`For the purposes of this review I have construed each claim term in
`
`accordance with its plain meaning ie its ordinary and customary meaning under
`
`the required broadest
`
`reasonable interpretation in light of the specification of the
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`504 patent and prosecution history
`
`30
`
`I understand that a patent claim is adequately described by the
`
`specification of the patent and thus in compliance with the first paragraph of
`
`35 USC § 112 if the specification reasonably conveys to a POSA that the
`
`inventors was in possession of the claimed subject matter as of the patents filing
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`date I further understand that possession can be demonstrated in multiple ways
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`12
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`BioRad Exhibit 2001
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
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`including words and figures
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`31
`
`is my understanding that a claim is anticipated under 35 USC
`
`It
`
`§ 102 if each and every limitation of the claim is disclosed in a single prior art
`
`reference either expressly or inherently I understand inherent disclosure to mean
`
`that
`
`the claim feature necessarily flows from the disclosure of the prior art
`
`reference
`
`32
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`I understand that a claim is unpatentable under 35 USC § 103 if the
`
`claimed subject matter as a whole would have been obvious to a POSA at the time
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`of the alleged invention which I have been instructed to treat at present as May 8
`
`2003 I also understand that an obviousness analysis takes into account
`
`the scope
`
`and content of the prior art the differences between the claimed subject matter and
`
`the prior art and the level of ordinary skill
`
`in the art at the time of the invention
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`III
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`PROPOSED CLAIM CONSTRUCTION
`
`33
`I understand that TFS argues that three terms recited in the 504 patent
`claims warrant construction 1 heating element 2 heater and 3 sample
`wells Pet 45 The term heating element is recited in independent claim 1 of the
`
`504 patent while independent claim 13 recites the term heater Both claims 1 and
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`13 also recite the term sample wells
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`34 My interpretations of the three terms proposed for construction by
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`TFS are below These definitions are the meanings a person of ordinary skill
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`in the
`
`13
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`BioRad Exhibit 2001
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
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`art would ascribe to the indicated terms at the relevant priority date in view of the
`
`patent specification and prosecution history
`A
`
`Heating Element And Heater
`
`35
`
`It
`
`is my opinion that the broadest
`
`reasonable interpretation of heating
`
`element recited in claim 1 and heater recited in claims 13 and 22 in view of
`
`the specification and prosecution history of the 504 patent are lid heaters of the
`
`504 patent specification ie a separate plate or block that provides heat is
`
`positioned between the sample block and detection module and allows the
`
`detection module to optically communicate with sample wells in the sample
`
`block The basis for my opinion as well as an explanation why TFS proposed
`
`construction is not correct
`
`is provided below
`
`1
`
`The Plain Language Of The 504 Patent Claims
`
`36
`
`Claims 1 and 13 of the 504 patent both recite sample wells of a
`
`thermal cycler A POSA will understand that sample wells of thermal cyclers are
`
`generally located in a temperature controlled block which can alternatively be
`
`referred to as eg a sample block a sample unit or a thermal cycling block and
`the temperature of reaction vessels eg tubes placed in
`
`are designed to control
`
`the wells Each claim recites a second structure that heats the heating element
`
`of claim 1 and heater of claim 13 Claims 1 and 13 both make it clear that the
`
`two structures capable of providing heat are separate and distinct from each other
`
`14
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`BioRad Exhibit 2001
`IPR201700054
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
`US Patent No 8236504
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`For example claim 1 recites that the heating element is disposed between the
`
`detection module and the sample wells Similarly claim 13 recites that the
`
`sample wells are on one side of the heater while the detection module is on the
`
`other side A POSA will recognize that because the heating element of claim 1 and
`
`heater of claim 13 are discussed as one entity while sample wells are discussed as
`
`a completely different entity that each claim requires two separate structures
`
`capable of providing heat
`
`37
`
`The only limitation the 504 patent claims place on positioning of the
`
`heating element claim 1 and heater claim 13 is that they are oriented between
`
`the sample wells and detection module of the claimed apparatuses Claim 1
`
`explicitly recites the term between in relation to the heating elements
`
`positioning while claim 13 mandates that the detection module and sample wells
`
`of the apparatus are on opposite sides of the heater A POSA will understand
`
`that
`
`the heater of claim 13 must be between the sample wells and detection module
`
`in the apparatus if the latter two components
`
`fall on opposite sides of it On this
`
`point TFS Dr Mathies and I appear to be in agreement Pet 8 Ex 10021132
`
`Ex 2003 Mathies Tr 352425 Claim 13 requires that the heater be between
`
`the detection module and the sample wells
`
`38
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`The heating element claim 1 and heater claim 13 both must allow
`
`the detection module to optically communicate with sample wells This is
`
`15
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`IPR201700054
`Page 17 of 49
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`
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`Declaration of Dean P Neikirk PhD
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`Case IPR201700054 for
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`accomplished via holesopenings in the heating elementheater Claim 1 recites
`
`that
`
`the heating element has a plurality of openings extending through the heating
`
`element while claim 13 recites that the heater has a plurality of transparent
`
`portions Claim 22 which depends from claim 13 specifies that the transparent
`
`portions simply can be a plurality of holes Irrespective of the differential word
`
`choice a POSA will appreciate that due to their positioning between the sample
`
`wells and detection module both the heating element and heater recited in the
`
`claims must be designed in a manner that allows excitation light from the detection
`
`module and emission light from the samples to pass through the heating
`
`elementheater Otherwise the claimed apparatuses would be dysfunctional
`
`39
`
`In sum a plain reading of the 504 patent claims confirms that the
`
`essential
`
`heating element of claim 1 and heater of claim 13 share three common and
`features 1 they are not the structure comprising sample wells ie they
`are not a sample unitblock 2 they are positioned between the detection module
`and sample wells and 3 they contain a structural modification eg
`
`holesopenings that allows the detection module to be in optical communication
`
`with the sample wells The claims do not recite a lid and therefore do not require
`
`that
`
`the heating element or heater be coupled to a lid
`
`40
`
`Therefore having read the claims of the 504 patent a POSA would
`
`not have needed to avail themselves of the disclosure of the 504 patent
`
`in order to
`
`16
`
`BioRad Exhibit 2001
`IPR201700054
`Page 18 of 49
`
`
`
`Declaration of Dean P Neikirk PhD
`
`Case IPR201700054 for
`US Patent No 8236504
`
`construe heating element and heater in the manner I have done above ie as a
`
`separate plate or block that provides heat is positioned between the sample block
`
`and detection module and allows the detection module to optically communicate
`
`with sample wells in the sample block However as I explain below if a POSA
`
`did turn to the specification of the 504 patent
`
`to construe either term they would
`
`recognize that the lid heaters disclosed in the exemplary apparatuses fundamental
`
`to the 504 patent are the physical structures that correlate with the heating element
`
`of claim 1 and heater of claim 13
`
`2
`
`The Specification Of The 504 Patent
`
`41
`
`Figure 2 which I reproduce below is a representation of an apparatus
`
`embodied by both claims 1 and 13 of the 504 patent This figure depicts an
`
`exemplary apparatus that comprises a detection module colored in green a
`
`sample unit with sample wells colored in yellow and a lid heater colored in red
`
`with the lid heater positioned between the detection module and sample wells It
`
`is
`
`selfevident that the lid heater 204 and the sample unit 202 that contains sample
`
`wells 210 are separate structures Further the lid heater is designed to allow
`
`communication between the detection module and the sample wells there are
`
`holesopenings 220 throughout
`
`the lid heater that allow the detection module to
`
`optically access the sample wells
`
`17
`
`BioRad Exhibit 2001
`IPR201700054
`Page 19 of 49
`
`
`
`Declaration of Dean P Neikirk PhD
`
`Case IPR201700054 for
`US Patent No 8236504
`
`Ex 1001 504 Patent Fig 2
`
`42
`
`Figure 6 provides an alternate view of the detection modulelid
`
`heatersample well relationship of the apparatuses central to the 504 patent
`
`that
`
`are captured by claims 1 and 13 Like Figure 2 Figure 6 shows an exemplary
`
`apparatus that comprises a detection module a sample unit with a sample well
`
`with an exemplary reaction vessel
`
`in the well and a lid heater Again it
`
`is clear
`
`that
`
`the lid heater and sample unit are distinct
`
`from one another
`
`from a structural
`
`perspective
`
`It also is evident that the lid heater is positioned between the detection
`
`module and sample wells Finally consistent with all apparatuses of the 504 patent
`
`comprising a lid heater the lid heater shown in Figure 6 contains a holeopening
`
`that allows the detection module to communicate with the sample wells
`
`18
`
`BioRad Exhibit 2001
`IPR201700054
`Page 20 of 49
`
`
`
`Declaration of Dean P Neikirk PhD
`
`Case IPR201700054 for
`US Patent No 8236504
`
`43
`
`The written portion of the specification that describes Figures 2 and 6
`
`corroborates what a POSA would take from a simple visual
`
`inspection of the
`
`figures as I describe above In particular the lid heater is always described as
`
`being a separate entity from the sample unitsample block that contains sample
`
`wells Ex 1001 43740 512 72433 Additionally the specification makes it
`
`clear that when used in the disclosed apparatuses lid heaters must be positioned
`
`between the detection module and sample wells of the apparatuses and must allow
`
`the detection module to optically communicate with the sample wells Id 512
`
`54751 73033
`
`44
`
`It also is worth pointing out that as acknowledged
`
`by the specification
`
`of the 504 patent Ex 1001 4043 lid heaters were known in the art and
`
`conventional as of the earliest filing date of the 504 patent Thus a POSA would
`
`have recognized that lid heaters other than those recited in the 504 patent
`
`specification are relevant to the apparatuses claimed in the patent so long as they
`
`satisfy the limitations common to the heating element of claim 1 and heater of
`
`claim 13
`
`45
`
`The specification of the 504 patent supports the construction of the
`
`terms heating element and heater that a plain reading of claims 1 and 13 dictates I
`
`cannot
`
`identify any portion of the 504 patent specification that suggests that a plate
`
`or block that provides heat is positioned between the sample block and detection
`
`19
`
`BioRad Exhibit 2001
`IPR201700054
`Page 21 of 49
`
`
`
`Declaration of Dean P Neikirk PhD
`
`Case IPR201700054 for
`US Patent No 8236504
`
`module and allows the detection module to optically communicate with sample
`
`wells in the sample block in the context of the apparatuses claimed and disclosed
`
`in the 504 patent would be anything other than a lid heater
`
`3
`
`The Prosecution History Of The 504 Patent
`
`46 My opinion of the proper construction of heating elementheater
`
`is
`
`consistent with the disclosure of lid heaters in the 504 patent specification and was
`
`confirmed by my review of the prosecution history of the 521 application which
`
`issued as the 504 patent
`
`47
`
`During prosecution in the same document that added the terms
`
`heating element and heater to the claim set BioRad pointed directly to
`
`Figure 2 of the specification as support for each limitation Ex 1004 pp 2627
`
`28 With respect
`
`to claim 1 in particular BioRad noted that Figure 2 supports the
`heating element limitation because it shows a lid heater
`
`disposed between
`
`sample wells
`
`and a detection module Id pp 2627
`
`48
`
`I cannot see how BioRad could have made it more clear to a POSA
`
`that
`
`the heating element and heater recited in the 504 patent claims are
`
`supported by the lid heaters of the 504 patent specification especially since as
`
`even TFS has acknowledged the 504 Patent only discusses two components
`
`that have a heating function
`
`namely a sample unit ie thermal cycling block
`
`and a lid heater Pet 4
`
`20
`
`BioRad Exhibit 2001
`IPR201700054
`Page 22 of 49
`
`
`
`Declaration of Dean P Neikirk PhD
`
`Case IPR201700054 for
`US Patent No 8236504
`
`4
`
`TFS Proposed Construction Is Incorrect
`
`49
`
`In what essentially are identical paragraphs TFS and its expert
`
`Dr Mathies argue that the terms heating element and heater should be
`
`considered equivalent Pet 4 Ex 10021124 TFS and Dr Mathies both
`
`acknowledge
`
`that the apparatuses of the 504 patent are disclosed as having two
`
`separate heating components
`
`a sample unit which TFS and Dr Mathies also
`
`refer to as a thermal cycling block and a lid heater
`
`and that the heating
`
`element and heater recited in the claims meet the functional
`
`requirements of the
`
`specifications lid heaters Id
`
`50
`
`However TFS and Dr Mathies argue that the heating elementheater
`
`should not be construed as limited to lid heaters disclosed in the specification of
`
`the 504 patent
`
`Id The basis for this argument stems entirely from the fact
`
`that
`
`claim 21 of the 504 patent which depends from claim 13 but not from claim 1
`
`encompasses an apparatus where a detection module is placed below sample wells
`
`rather than above sample wells as shown in for example Figures 2 and 6 of the
`
`504 patent Pet 5 Ex 10021124 In particular both TFS and Dr Mathies state
`
`that artisans would have understood that an optics head placed below sample
`
`wells as required by claim 21 could not view the wells through the lid heater
`
`disclosed in the 504 patent specification which is only described as necessarily
`
`placed on top of the wells Id I disagree with TFS and Dr Mathies proposed
`
`21
`
`BioRad Exhibit 2001
`IPR201700054
`Page 23 of 49
`
`
`
`Declaration of Dean P Neikirk PhD
`
`Case IPR201700054 for
`US Patent No 8236504
`
`construction
`
`51
`
`Neither claim 1 nor claim 13 of the 504 patent specify whether the
`
`detection module of the recited apparatuses is placed on the bottom or top of
`
`the sample wells As discussed in detail above see eg ¶37 however each
`
`claim does mandate specific positioning of components of the apparatuses the
`
`heating elementheater
`
`is required to be positioned between the detection module
`
`and sample wells which are located in a sample unitblock Claims 1 and 13 also
`
`require that the heating elementheater allow the detectio
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