UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Jubilant DraxImage Inc.
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`Petitioner
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`v.
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`Bracco Diagnostics Inc.
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`Patent Owner
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`U.S. Patent No. 9,299,467
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`Inter Partes Review Case No.: IPR2018-01449
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`EXHIBIT 1015
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`DECLARATION OF ROBERT T. STONE, Ph.D.
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`JUBILANT EXHIBIT 1015
`Jubilant v. Bracco, IPR2018-01449
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`Inter Partes Review Case No. IPR2018-01449
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`TABLE OF CONTENTS
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`Page
`Introduction and Qualifications ....................................................................... 1
`I.
`II. Materials Reviewed ......................................................................................... 5
`III. The Applicable Law ........................................................................................ 7
`A. General Patent Law ............................................................................... 7
`B.
`Anticipation ........................................................................................... 8
`C.
`Obviousness ........................................................................................... 9
`IV. Level of Ordinary Skill in the Art ................................................................. 14
`V.
`Claim Construction ........................................................................................ 19
`VI. Overview of Opinion ..................................................................................... 22
`VII.
`Introduction to the ’467 Patent ...................................................................... 23
`VIII. Overview of the Prior Art .............................................................................. 35
`A. Medical Uses of Rubidium-82 ............................................................ 36
`B.
`Rubidium-82 Infusion Risks and Precautions ..................................... 39
`C.
`Design Considerations for Limiting Radiation Exposure ................... 42
`D. General Equipment Design Considerations ........................................ 51
`IX. Cited Prior Art ............................................................................................... 53
`A.
`State of Prior Art in General ............................................................... 53
`B.
`Klein (Ex. 1014) .................................................................................. 54
`C.
`Tate (Ex. 1022) .................................................................................... 71
`D.
`Bracco Manual (Ex. 1021) .................................................................. 73
`Comparison of Klein to References Considered During Prosecution of
`the ’467 Patent ............................................................................................... 77
`XI. Klein Anticipates Claims 1-4, 6-7, 9-10, 12-16, and 18-20 .......................... 87
`A. Klein Anticipates Independent Claim 1 .............................................. 87
`B.
`Klein Anticipates Dependent Claim 2 ............................................... 106
`C.
`Klein Anticipates Dependent Claim 3 ............................................... 108
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`X.
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`Inter Partes Review Case No. IPR2018-01449
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`D. Klein Anticipates Dependent Claim 4 ............................................... 111
`E.
`Klein Anticipates Dependent Claim 6 ............................................... 113
`F.
`Klein Anticipates Dependent Claim 7 ............................................... 115
`G. Klein Anticipates Dependent Claim 9 ............................................... 117
`H. Klein Anticipates Dependent Claim 10 ............................................. 120
`I.
`Klein Anticipates Dependent Claim 12 ............................................. 121
`J.
`Klein Anticipates Independent Claim 13 .......................................... 123
`K. Klein Anticipates Dependent Claim 14 ............................................. 135
`L.
`Klein Anticipates Dependent Claim 15 ............................................. 137
`M. Klein Anticipates Dependent Claim 16 ............................................. 139
`N. Klein Anticipates Dependent Claim 18 ............................................. 142
`O. Klein Anticipates Dependent Claim 19 ............................................. 144
`P.
`Klein Anticipates Dependent Claim 20 ............................................. 147
`XII. Klein and Tate Render Claims 11 and 22 Obvious ..................................... 149
`A. Motivation to Combine References .................................................. 151
`B.
`No Secondary Considerations ........................................................... 154
`C.
`Klein and Tate Render Dependent Claim 11 Obvious ...................... 154
`D. Klein and Tate Render Dependent Claim 22 Obvious ...................... 160
`XIII. Claims 8 and 21 are Obvious Over Klein in View of the Bracco Manual .. 166
`A. Motivation to Combine References .................................................. 167
`B.
`No Secondary Considerations ........................................................... 168
`C.
`Klein and the Bracco Manual Render Dependent Claim 8 Obvious 169
`D. Klein and the Bracco Manual Render Dependent Claim 21
`Obvious ............................................................................................. 170
`XIV. Declaration in Lieu of Oath ......................................................................... 172
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`I.
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`Inter Partes Review Case No. IPR2018-01449
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`I, Robert T. Stone, declare as follows:
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`INTRODUCTION AND QUALIFICATIONS
`I understand that Jubilant DraxImage, Inc. (“Petitioner”) is petitioning
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`the United States Patent and Trademark Office (“USPTO”) for inter partes review
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`of claims 1-4, 6-16, and 18-22 (the “Challenged Claims”) of U.S. Patent No.
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`9,299,467 (“the ’467 Patent”). I have been retained by Petitioner to offer technical
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`opinions relating to the ’467 Patent and certain prior-art references relating to its
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`subject matter.
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`I received a B.S. in Electrical Engineering from Virginia Polytechnic
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`Institute and State University (“Virginia Tech”) in 1977; an M.S. with distinction in
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`Electrical Engineering from Virginia Polytechnic Institute and State University in
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`1979; and a Ph.D. in Electrical Engineering from Stanford University in 1981. After
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`receiving my Ph.D., I worked as an Assistant Professor of Engineering at Virginia
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`Polytechnic Institute and State University until 1983. Since that time, I have worked
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`continuously in industry in the field of medical electronics systems and
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`instrumentation. Since 2004, I have served as Chief Technical Officer or Chief
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`Executive Officer of various entities, where I have been responsible for virtually all
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`phases of product development including concept definition, prototyping, design,
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`evaluation, patenting, and technology licensing for various medical devices.
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`Inter Partes Review Case No. IPR2018-01449
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`I spent six years in the United States Navy between 1965 and 1971
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`where I worked as a nuclear reactor operator, electronics technician, and engineering
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`watch supervisor. During this time I achieved the rank of Electronics Technician
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`(Nuclear) First Class (E-6). I spent two of these years as an instructor in nuclear
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`theory and instrumentation at the Navy’s Schenectady New York Nuclear Power
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`Prototype facility.
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` While pursuing my degrees at Virginia Tech, I managed and maintained
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`a research and teaching nuclear reactor which routinely performed neutron activation
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`analysis as a research service to university, state, and industry laboratories. In this
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`role I participated in the University Safety Committee and the Reactor Safety
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`Committee, directly interfaced with the Nuclear Regulatory commission, and was
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`responsible for compliance with all applicable nuclear device regulations.
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`
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`After obtaining my Ph. D. in electrical engineering from Stanford
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`University in 1981, I returned to Virginia Tech where I served as an Assistant
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`Professor of Engineering. In addition to my teaching responsibilities, I was
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`responsible for obtaining research funding for the analysis of control systems for
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`nuclear reactors. Thus, I am familiar with safety protocols for nuclear materials.
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`I have over 35 years of experience designing and developing medical
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`devices, electronic systems, and instrumentation, including significant experience
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`with computer-controlled drug-delivery systems.
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`Between 1983 and 1989, I was the Manager of Electronic Research for
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`Nellcor, Inc. where I was responsible for the research and development of new
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`products including computer-controlled medical devices in the area of blood gas
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`monitoring, oxygen saturation, carbon dioxide gas analysis, and cardiac output
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`equipment, including overseeing prototype development and clinical validation of
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`new systems.
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`From 1989 to 1991, I served as the Vice President of Engineering for
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`MedaSonics, Inc., where I managed a group of engineers, technicians, and designers
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`working on the design and development of computer-controlled portable vascular
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`analysis equipment used in clinics, hospitals, and physicians’ offices.
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`
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`From 1991 to 1996, I was the Chief Technical Officer and Vice
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`President of Research and Development at Natus Medical, Inc. In this role I was
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`responsible for all phases of development of novel computer-controlled hearing
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`screening devices, including prototyping, design, and validation. These screening
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`devices were integrated into medical carts. I was also responsible for regulatory
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`compliance, including FDA clearance of new devices and obtaining UL, CSA, and
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`CE listings for our products.
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` Since 1997, I have worked continuously as a senior executive at various
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`consulting and contract design firms where I have been responsible for virtually all
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`phases of new product development including concept definition, prototyping,
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`design, validation, and manufacturing for a wide range of medical devices and
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`Inter Partes Review Case No. IPR2018-01449
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`medical equipment. During that time, my work has included working with
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`ventilators, computer-connected cardiac catheters, venous ablation systems, wireless
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`EKG systems, and wireless multifunction monitors that are connected and interface
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`with electronic health record systems. I also have extensive experience working
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`with implantable and cardiac assistive pumps, including wirelessly controlled pumps
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`and computer-controlled remote patient monitors, as well as computer-connected
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`dialysis machines, cart-based cardiac ablation devices, and blood analyzers.
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`
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`In my 35 years working in medical device research and development I
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`have been an inventor on more than 20 U.S. Patents and listed as an inventor in
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`numerous additional applications. I have extensive experience with the risk
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`assessment and risk management practices utilized in the design and development
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`of medical devices, as well as the various regulatory structures that apply.
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` My curriculum vitae, which is Exhibit 1016, contains a more detailed
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`description of my background.
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`
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`I am being compensated at my usual consulting rate of $650 per hour
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`for my technical analysis in this matter. My compensation is not contingent upon
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`the results of my work.
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`II.
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`Inter Partes Review Case No. IPR2018-01449
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`MATERIALS REVIEWED
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`I have reviewed various documents in forming my opinions, including
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`the documents referenced herein and the following listed documents:
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`EXHIBIT
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`DESCRIPTION
`
`1001
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`U.S. Patent No. 9,299,467
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`Prosecution History, U.S. application s.n. 12/137,356
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`Prosecution History, U.S. application s.n. 12/137,377
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`Prosecution History, U.S. application s.n. 12/137,363
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`Prosecution History, U.S. application s.n. 12/137,364
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`Prosecution History, U.S. application s.n. 12/808,467
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`Prosecution History, U.S. application s.n. 14/455,623
`
`Alvarez-Diez, “Manufacture of strontium-82/rubidium-82
`generators and quality control of rubidium-82 chloride for
`myocardial perfusion imaging in patients using positron
`emission tomography,” Applied Radiation and Isotopes, v. 50,
`pp. 1015-23 (1999)
`
`Klein et al, “Precision Control of Eluted Activity from a
`Sr/Rb Generator for Cardiac Positron Emission Technology,”
`Engr. in Med. and Biology Soc. 26th Annual International
`Conference of the IEEE, vol. 1, pp. 1393-1396 (2004)
`
`Ran Klein, “Precise 82Rb Infusion System for Cardiac
`Perfusion Measurement Using 3D Positron Emission
`Tomography,” Ottawa-Carleton Institute for Electrical and
`Computer Engineering (Feb. 2005)
`
`1017
`
`Declaration of Ventakesh Murthy, M.D.
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`EXHIBIT
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`1029
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`1030
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`Inter Partes Review Case No. IPR2018-01449
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`DESCRIPTION
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`Barker, et al., U.S. Patent 4,585,009, granted April 29, 1986
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`U.S. Pharmacopeia 23 National Formulary 18 (1995)
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`Declaration of Andy Adler, Ph.D.
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`Bracco CardioGen-82® Infusion System User’s Guide, Rev.
`07 (July 20, 2004)
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`Tate, et al., U.S. Patent Publication No. 2008/0177126, filed
`October 31, 2007 and published July 24, 2008
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`ISO 13485:2003 – Medical Devices – Quality Management
`Systems – Requirements for Regulatory Purposes (July, 2003)
`
`21 CFR Part 820.1 (2005)
`
`Chatal, et al., “Story of rubidium-82 and advantages for
`myocardial perfusion PET Imaging,” Frontiers in Medicine, v.
`2, art. 65, pp. 1-7 (Sept. 11, 2015)
`
`Bracco CardioGen-82® Rubidium Rb 82 Generator, Rev. 43-
`8200 (May 2000)
`
`10 CFR Part 20 (10 CFR 20.1001-2)
`
`10 CFR Part 20 (10 CFR 20.1003)
`
`EN 62274:2005 – Medical Electrical Equipment – Safety of
`Radiotherapy Record and Verify Systems (December 28,
`2005)
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`The Chemical Rubber Co., Handbook of Radioactive
`Nuclides, Yen Wang ed., 1969
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`EXHIBIT
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`1031
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`1033
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`1034
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`Inter Partes Review Case No. IPR2018-01449
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`DESCRIPTION
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`Complainant Bracco Diagnostics Inc.’s Responses to
`Respondent’s Fourth Set of Interrogatories (No. 68), In the
`Matter of Certain Strontium-Rubidium Radioisotope Infusion
`Systems, and Components Thereof Including Generators, Inv.
`No. 337-TA 3303 (U.S. I.T.C.)
`
`deKemp, U.S. Publ’n 2007/0213848
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`deKemp U.S. Publ’n 2007/0140958
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`III.
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`THE APPLICABLE LAW
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`I am not an attorney, and I am not providing any expert opinions on the
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`law. However, I have been advised of certain basic legal principles applicable to my
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`analysis in this report, and I have applied those principles in forming my opinions.
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`Those principles are provided below:
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`A. General Patent Law
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`I understand that determining the validity of a patent requires a two-
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`step analysis. First, the meaning and scope of the patent claims are construed, and
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`then the construed claims are compared to the prior art.
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`I understand that, in the context of an inter partes review, the prior art
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`may comprise patents or printed publications. I also understand that the phrase
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`“printed publication” means publications sufficiently accessible to the public
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`interested in the art and depends upon dissemination and accessibility.
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`B. Anticipation
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`It is my understanding that to prove anticipation under 35 U.S.C. § 102
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`(the pre-America Inventions Act version), the challenger of the patent’s validity
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`must show that all of the requirements of that claim were present in a previous
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`method or system that was described in a single previously printed publication or
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`patent. To anticipate a claim, the prior art does not have to use the same words as
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`the claim, but all of the requirements of the claim must have been disclosed, either
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`stated expressly or inherently, to a person having ordinary skill in the art at the time
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`of the alleged invention, so that looking at that one reference, that person could make
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`and use the claimed invention.
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`I understand that when considering disclosure of a prior art document,
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`one reviews it from the perspective of a “person having ordinary skill in the art”
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`(“POSITA”), a hypothetical person who is presumed to have background knowledge
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`of the relevant art at the time of the invention.
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`I understand that a prior art document anticipates a claim when it
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`expressly discloses every limitation of the claim within the four corners of the
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`document and those limitations are arranged or combined in the same way as recited
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`in the claim. To be anticipatory, a prior art reference must further enable one skilled
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`in the art to make the anticipating subject matter.
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`I further understand that even when a prior art document does not
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`expressly disclose every limitation of the claim, it may inherently anticipate the
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`claim when the reference’s disclosure makes it clear to persons of ordinary skill that
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`the missing descriptive matter is necessarily present in the thing described in the
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`reference. I understand that the question of whether missing descriptive matter is
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`inherent in a prior art reference may be answered by looking to extrinsic evidence.
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`I further understand that inherency may not be established by probabilities or
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`possibilities, and the mere fact that a certain thing may result from a given set of
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`circumstances is not sufficient.
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` Claims and prior art references sometimes assign numerical values to
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`elements, either as discrete values or as ranges of values. I understand that, when a
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`prior art reference discloses values or a range that falls within a claimed range (and
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`the reference discloses all other elements of the claim), the prior art reference
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`anticipates the claim.
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`C. Obviousness
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`It is my understanding that, to prove that a claim is invalid for
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`obviousness under 35 U.S.C. § 103 (the pre-America Invents Act version), the
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`challenger of its validity must prove that, for example, two or more prior art
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`references in combination disclose, expressly or inherently, every claim limitation
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`and also that the claim, as a whole, would have been obvious to a person of ordinary
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`skill in the art at the time the alleged invention was made.
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`It is my understanding that the relevant standard for obviousness under
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`35 U.S.C. § 103(a) is as follows:
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`A patent may not be obtained though the invention is not identically
`disclosed or described as set forth in section 102, if the differences
`between the subject matter sought to be patented and the prior art are
`such that the subject matter as a whole would have been obvious at the
`time the invention was made to a person having ordinary skill in the art
`to which said subject matter pertains. Patentability shall not be
`negatived by the manner in which the invention was made.
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`In determining whether or not a patented invention would have been
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`obvious, the following so-called Graham factual inquiries must be made: (1) the
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`scope and content of the prior art; (2) the differences between the prior art and the
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`claims at issue; (3) the level of ordinary skill in the pertinent art at the time the
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`alleged invention was made; and (4) any secondary considerations, including
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`commercial success, long felt but unsolved needs, failure of others, etc.
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`I understand that a patent composed of several elements is not proved
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`obvious merely by demonstrating that each of its elements was independently known
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`in the prior art. Most, if not all, inventions rely on building blocks of prior art. The
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`challenger of a patent’s validity must prove that, at the time of the claimed invention,
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`there was a reason that would have prompted a person having ordinary skill in the
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`Inter Partes Review Case No. IPR2018-01449
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`field of the invention to combine the known elements in a way the claimed invention
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`does, taking into account such factors as:
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`a.
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`whether the claimed invention was merely the predictable result of
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`using prior art elements according to their known function(s);
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`b.
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`whether the claimed invention amounted to nothing more than using a
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`known technique to improve similar devices or methods in the same
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`way;
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`c.
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`whether the claimed invention provides an obvious solution to a known
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`problem in the relevant field;
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`d.
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`whether the prior art teaches or suggests the desirability of combining
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`elements claimed in the invention;
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`e.
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`whether the prior art teaches away from combining elements in the
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`claimed invention;
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`f.
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`whether it would have been obvious to try the combinations of
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`elements, such as when there is a design need or market pressure to
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`solve a problem and there are a finite number of identified, predictable
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`solutions; and
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`Inter Partes Review Case No. IPR2018-01449
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`g.
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`whether the change resulted more from design incentives or other
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`market forces.
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` To find the invention obvious in light of a prior art combination, the
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`prior art combination must have provided a reasonable expectation of success.
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`I understand that when considering the teachings of a prior art
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`document, one reviews it from the perspective of a “person having ordinary skill in
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`the art” (“POSITA”) a hypothetical person who is presumed to have known the
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`relevant art at the time of the invention. Familiar items may have obvious uses
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`beyond their primary purposes, and in many cases a POSITA will be able to fit the
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`teachings of multiple patents together like pieces of a puzzle. Often, it will be
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`necessary to look to interrelated teachings of multiple prior art references; the effects
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`of demands known to the design community or present in the marketplace; and the
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`background knowledge possessed by a POSITA, all in order to determine whether
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`there was an apparent reason to combine the known elements in the fashion claimed
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`by the patent at issue. When a work is available in one field of endeavor, design
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`incentives and other market forces can prompt variations of it, either in the same
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`field or a different one. If a POSITA can implement a predictable variation, § 103
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`likely bars its patentability.
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`
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`I further understand that it is not permissible to use hindsight in
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`assessing whether a claimed invention is obvious. Rather, I understand that, to
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`assess obviousness, you must place yourself in the shoes of a person having ordinary
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`Inter Partes Review Case No. IPR2018-01449
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`skill in the relevant field of technology at the time the alleged invention was made
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`who is trying to address the issues or solve the problems faced by the inventor,
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`considering only what was known at the time of the invention and ignoring the
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`knowledge you currently now have of the inventions.
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` Claims and prior art references sometimes assign numerical values to
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`elements, either as discrete values or as ranges of values. I understand that, when a
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`prior art reference discloses a range that overlaps a claimed range, there is a
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`presumption of obviousness. I further understand that a range disclosed by prior art
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`can render a claimed range obvious even when the ranges do not overlap but they
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`are close enough to be recognized by a skilled artisan to have the same properties.
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`If, however, a claimed range proves to be critical to the operation of an invention or
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`it provides unexpected results, then the presumption of obviousness may be rebutted.
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` Regarding the fourth step in the four-step process for assessing
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`obviousness (the so-called Graham inquiries), specifically the step involving
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`“objective considerations,” I have been told that some of the factors that may be
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`considered are those of copying, a long felt but unsolved need, failure of others,
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`commercial success, unexpected results created by the claimed invention,
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`unexpected properties of the claimed invention, licenses showing industry respect
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`for the invention, and skepticism of skilled artisans before the invention was made.
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`I understand that in order for these objective considerations to demonstrate non-
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`obviousness, there must be a nexus between the claimed features and the objective
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`evidence of secondary considerations that is offered. As explained below, I have no
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`reason to believe that any of these factors apply to the Challenged Claims of the ’467
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`Patent.
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`IV.
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`LEVEL OF ORDINARY SKILL IN THE ART
`
`I understand there is a concept in patent law known as the “person
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`having ordinary skill in the art.” I understand that this concept refers to a person
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`who is trained in the relevant technical field of a patent without possessing
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`extraordinary or otherwise exceptional skill. I further understand that factors such
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`as the educational level of those working in the field, the sophistication of the
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`technology, the types of problems encountered in the art, prior art solutions to those
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`problems, and the speed at which innovations are made may help establish the level
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`of skill in the art. I understand the level of skill of the persons of ordinary skill is to
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`be assessed at the time of the claimed invention.
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`
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`In reviewing the ’467 Patent to determine the level of ordinary skill in
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`the art, I have arrived at my opinion that the “art” described by the ’467 Patent
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`pertains primarily to computer-controlled safety systems for radioactive materials
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`and to medical devices.
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` The discussions in the ’467 Patent about systems and methods for
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`computer-controlled safety systems for radioactive materials would have been well
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`known to graduate students in disciplines with some emphasis in equipment design,
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`automation, or controls, such as electrical engineering, systems engineering,
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`mechanical engineering, by the time they graduated in the 2008 time period (the year
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`of the earliest claimed priority date of the ’467 Patent). At that timeframe, these
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`topics also would have been well known to someone with an undergraduate degree
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`in these fields with two to three years’ work experience in radioactive protection
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`systems or with medical device product, automation, or instrumentation design and
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`development, including work with prototypes and finished commercial products.
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` Taking the relevant factors into consideration, it is my opinion that a
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`person of ordinary skill in the art as of June 11, 2008, the earliest priority date
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`claimed by the ’467 Patent, would have had a graduate’s degree with some emphasis
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`in equipment design, automation, or controls, such as electrical engineering,
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`systems engineering, mechanical engineering, or a related field, or an undergraduate
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`degree in one of those fields with two to three years’ work experience in radioactive
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`protection systems or in medical device product, automation, or instrumentation
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`design and development, including working with prototypes and finished products.
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`Such a person would have had a basic understanding, through education or
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`experience, of general design control principles and processes and practices for
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`Inter Partes Review Case No. IPR2018-01449
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`partial or full automation of existing processes or test procedures.
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`In my opinion, I would qualify as a person with at least ordinary skill
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`under this standard. As of 2008, I held multiple college degrees, including a master’s
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`degree and a Ph. D in electrical engineering and over twenty-five years of industry
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`experience as an engineer, including 14 years working experience with radioactive
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`material and associated safety systems therefore, and 25 years working experience
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`designing medical devices.
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` Further, at least through my work as an engineering manager and senior
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`executive in the medical device and instrumentation industry, I am familiar with the
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`level of ordinary skill in the art as of 2008 under this standard. As explained above
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`and in my curriculum vitae, as of 2008, I had more than two decades of experience
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`work as, working with, and supervising those of ordinary skill in this field.
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`I am informed that the Patent Owner has offered the following
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`definition of a POSITA in the related ITC case involving patents that are
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`continuations from the ’467 Patent and possess the same written description:
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`A person of ordinary skill in the art (“POSITA”) at the time of the
`invention claimed in the Asserted Patents [the patents asserted in the
`ITC case] would generally have a graduate degree in medicine and/or
`in a medical related science, including physics, chemistry, biology,
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`Inter Partes Review Case No. IPR2018-01449
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`physiology, and/or biophysics, or a related field, and would generally
`have at least some clinical, research, and/or design experience with
`respect to Positron Emission Tomography (“PET”) imaging and/or PET
`imaging systems.
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`Ex. 1031. I disagree for several reasons.
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` First, the proposed definition describes people that do not design
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`infusion systems. As explained herein, the Challenged Claims are directed to
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`computer-controlled infusion systems (and method for use) which contain hardware
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`and software components for infusing a dose of radiopharmaceutical to a patient,
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`shielding components to reduce radiation exposure, and a computer configured to
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`perform a routine strontium breakthrough test and prevent patient infusions from
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`occurring unless the strontium breakthrough test results are within a predetermined
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`limit. Designers of PET imaging systems—the systems that generate images from
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`radiation emitted from patients once radiopharmaceutical infusion occurs—
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`generally are concerned with designing systems that capture positron emissions from
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`patients and develop images from that data that are useful diagnostic tools. They do
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`not
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`concern
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`themselves with
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`design
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`techniques
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`for
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`administering
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`radiopharmaceuticals to patients or to the design of safety systems that ensure such
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`radiopharmaceuticals are within mandated safety limits. There are different design
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`criteria in place for PET imaging systems than for radiopharmaceutical infusion
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`systems.
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` Similarly, medical personnel generally do not design infusion systems.
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`Medical personnel who worked at the time with infusion systems would be familiar
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`with the procedures involved in performing strontium breakthrough tests because
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`the prevailing product on the market, the Cardiogen-82 infusion system (Ex 1021),
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`required such personnel to perform strontium breakthrough test computations
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`manually on a pencil-and-paper basis. Although medical personnel may understand
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`the physiological processes occurring after the radiopharmaceutical is infused and
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`the risks involved in infusion of unsafe radiopharmaceuticals, these types of medical
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`personnel typically lack the education or experience to design computer-controlled
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`systems that would automate the infusion and breakthrough testing processes at issue
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`or develop software-implemented safety systems for them.
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` On this issue, I note that the Klein thesis (Ex. 1014) on which many of
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`my opinions are based, is a student master’s thesis that was submitted Ottawa-
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`Carleton Institute for Electrical and Computer Engineering School of Information
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`Technology and Engineering (Electrical & Computer Engineering). It is not the
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`work product of a graduate student in a “medical-related science” as the Patent
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`Owner’s definition suggests.
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` Second, the definition fails to account for the differences between the
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`Challenged Claims and the prior art available to the POSITA. As noted, the Patent
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`Owner’s Cardiogen-82 infusion system, represented by Ex. 1021, required medical
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`personnel to perform strontium breakthrough testing by hand, and to calculate
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`strontium breakthrough test results by pencil-and-paper. See, Ex. 1021, at 34-35.
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`The ‘467 Patent does not change the testing methodology for strontium breakthrough
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`tests over these manual tests. Instead, it adds computer control to perform those
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`techniques by computer rather than by hand. See, Ex. 1001, FIG. 7C. As compared
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`to the Patent Owner’s prior product, the Challenged Claims add a touch screen
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`computer and computer-controlled
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`techniques
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`fo