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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
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`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.À.R.L.,
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`Patent Owner.
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`DECLARATION OF PAUL ZALESKY SUBMITTED IN CONNECTION
`WITH PETITIONERS’ REPLIES TO PATENT OWNER’S RESPONSES
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex. 1830
`Medtronic v. Teleflex
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`Page 1
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`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`I.
`QUALIFICATIONS ........................................................................................ 1
`II.
`SCOPE OF WORK .......................................................................................... 5
`III.
`IV. THE PERSON OF ORDINARY SKILL IN THE ART .................................. 6
`V.
`PATENT OWNER’S COPYING ALLEGATIONS ........................................ 6
`VI. CONCLUSION ..............................................................................................12
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`i
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`I.
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`Introduction
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`1.
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`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
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`Inc., and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
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`provide my opinions in connection with Inter Partes Review (“IPR”) petitions that
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`have been instituted on five patents: U.S. Pat. Nos. 8,048,032; RE45,380;
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`RE45,760; RE45,776; and RE45,379 (the “Root patents”):
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`IPR2020-00126, -00127, -00128, -00129, -00130, -00132, -00134, -00135, -00136,
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`-00137, and -00138.
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`2.
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`I make this declaration based on personal knowledge. I am over the
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`age of 21 and am otherwise competent to make this declaration.
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`II. Qualifications
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`3.
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`I summarize my educational background and career history in the
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`following paragraphs. My curriculum vitae is attached as Exhibit 1 to this
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`declaration.
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`4.
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`Following achievement of a B.S. (Univ. of Notre Dame) and M.S.
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`(Univ. of Michigan) in Aerospace Engineering, I attained a PhD in Biomedical
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`Engineering (Univ. of Michigan), publishing my thesis research on the prediction
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`of optimal surgical timing for the repair of Congenital Heart Defects. My industrial
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`career has been focused on the development and commercialization of specialty
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`medical devices for the diagnosis and treatment of heart disease, encompassing
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`more than 30 years of management and engineering positions in both large and
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`small companies.
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`5.
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`Following the initiation of “interventional” cardiology by Dr. Andreas
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`Gruntzig in the late ’70s, when he pioneered coronary balloon angioplasty, the
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`1980s saw the evolution of least invasive treatments of coronary artery disease
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`(CAD). Today, those treatments are generally referred to as interventional
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`cardiology. I became directly involved in the development of devices associated
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`with interventional cardiology. In 1986, I led Boston Scientific’s entry into the
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`coronary angioplasty (PTCA) market as Director of R&D, presenting device
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`efficacy data to the FDA towards a soon-approved Pre-Market Application (PMA).
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`In that role I also supervised the development of guide catheters and guidewires
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`needed as accessories to angioplasty.
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`6.
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`Later in 1986, I co-founded InterTherapy with cardiologist Dr. Walt
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`Henry. InterTherapy was focused on the development of intravascular ultrasound
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`for assessment of coronary disease that directed subsequent therapy. The
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`disposable component of the product was a 5 French coronary catheter with design
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`and materials that enabled its passage through standard guide catheters into the
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`branches of the coronary artery. From 1986 through 1990 I managed all company
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`operations, with an emphasis on device use in the cardiac catheterization labs of
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`Center of Excellence hospitals.
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`7.
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`I recruited, and worked closely with, Dr. Martin Leon, then a Fellow
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`at the National Institutes of Health, and collaborated with Dr. Leon on the creation
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`of a new, interventional cardiology symposium, Transcatheter Cardiovascular
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`Therapeutics, which subsequently evolved into the largest and most comprehensive
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`symposium in the field of interventional cardiology. I also collaborated closely
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`with cardiologists from multiple U.S. and European Centers of Excellence,
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`including the Mayo Clinic, Mass General Hospital, UCLA, Rhode Island Hospital,
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`Emory University, Stanford University, Clinico Cardiologica in Milan, Italy, and
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`many others. In this, and subsequent professional positions, I participated in
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`hundreds of patient cases in the cardiac catheter lab, donning protective lead
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`aprons while assisting or observing patient cases. The InterTherapy technology
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`effectively enabled the development and evolution of coronary stents, as the real-
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`time, intravascular imaging enabled review and optimization of stent deployment.
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`8.
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`In the early ’90s I served as Vice President R&D for a division of
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`Baxter International, where I led the development of and presented the
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`corporation’s interventional cardiology product portfolio to cardiologists and
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`associated symposia, including the development of critical devices for treatment of
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`CAD.
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`9.
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`In 1995 I co-founded, with cardiologist Dr. J. Richard Spears,
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`TherOx. TherOx was focused on the development of oxygen supersaturated
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`solutions to the coronary artery, following acute myocardial infarction (heart
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`attack). The primary product included a sub-selective catheter that could access
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`distal segments of the coronary branches, for fluid delivery. By sub-selective, I
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`mean a catheter that can be placed into and advanced through a larger catheter,
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`sometimes referred to as a “mother-and-child” catheter configuration. Boston
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`Scientific’s Target Tracker catheter was one such device that was advanced
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`through a guide catheter into the coronary arteries.
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`10.
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`In the 1995 to 2005 time period, myriad guide catheter configurations
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`were developed and tested by many different companies, including multi-hardness
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`bodies, multi-flexibility properties, various tip geometries and materials, and
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`various lumen geometries. Simultaneously, variations on angioplasty devices were
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`developed and tested, including catheters with active energy capability for lesion
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`(disease) ablation or removal, miniature balloons on wires, and selective
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`pharmacologic infusions. “Mother-and-child” catheters were developed and
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`commercialized by this time period. I was directly involved with cardiologist use
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`and assessment of these devices while directing and participating in formal clinical
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`studies in the U.S., Europe, Canada, and Israel.
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`11. During my time with Volcano Corporation (now Philips), I supervised
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`coronary and peripheral artery catheter development, manufacture, and clinical use.
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`12. Since 2013, I have focused on consulting, and I have provided expert
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`advice or opinions on numerous projects, including related to algorithms for
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`cardiac arrhythmia diagnosis, implantable cardiac defibrillators, blood oxygen
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`diagnostic devices, and cardiovascular devices associated with CAD treatment. For
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`one-and-a-half years I served as interim CEO for Keystone Medical, an Israel-
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`based start-up for the development of cerebral protection devices for use with
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`transcatheter heart valve replacement. Our product development activities included
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`cardiac delivery catheters, guidewires, and associated catheter lab procedures for
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`device insertion, deployment, use, and removal.
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`13.
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`In many of my management positions, I was responsible for
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`development and maintenance of intellectual property, including direct
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`management of in-house patent counsel and collaboration with outside patent
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`counsel. I am a named co-inventor on more than 20 issued U.S. patents, almost all
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`focused on cardiovascular, coronary artery devices.
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`III. Scope of Work
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`14.
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`I have been asked to review the Root patents as well as Patent
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`Owner’s (and Petitioner’s) evidence of record regarding the GuideLiner Version 3
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`product and Medtronic’s Telescope product in the context of Patent Owner’s
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`copying allegations. I have been asked to consider and offer opinions regarding
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`Patent Owner’s copying allegations.
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`IV. The Person of Ordinary Skill in the Art
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`15.
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`I am aware that Medtronic contends that a person of ordinary skill in
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`the art (“POSITA”) at the time of the alleged invention would have (a) had a
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`medical degree; (b) completed a coronary intervention training program; and (c)
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`had experience working as an interventional cardiologist. Alternatively, a POSITA
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`would have had (a) an undergraduate degree in engineering, such as mechanical or
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`biomedical engineering; and (b) three years of experience designing medical
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`devices, including catheters or catheter-deployable devices. Extensive experience
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`and technical training might substitute for education, and advanced degrees might
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`substitute for experience. Additionally, a POSITA with a medical degree may have
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`had access to a POSITA with an engineering degree, and one with an engineering
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`degree might have had access to one with a medical degree.
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`V.
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`Patent Owner’s Copying Allegations
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`16.
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`I understand that the secondary consideration of copying requires the
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`replication of a specific product.
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`17.
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`I understand that Patent Owner contends that “Medtronic copied
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`Version 3 of Guideliner” with its Telescope product. Patent Owner invites a
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`“side-by-side” comparison. And though noting differences between the two
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`products, Patent Owner maintains that Telescope is a “copy” of Version 3 of
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`GuideLiner. Patent Owner is incorrect.
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`18. Telescope employs a significantly different proximal pushwire design:
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`Ex-2071 at 7. The design of the proximal pushwire is critical to guide extension
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`catheter (GEC) pushability, torque control, and overall device handling.
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`
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` Ex-1821, 53:19-54:11. Telescope employs a significantly different
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`pushwire design—it consists of a solid, round wire that is tapered along its length
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`from a full circle proximally to a semicircle mid length to a tapered semicircle at
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`its termination. Its full length is 125 cm and its termination, via a weld to a
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`spade-shaped R/O marker band, occurs in close proximity to a sculpted entry port
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`in the catheter body. The GuideLiner Version 3 pushwire, by contrast, is 108 cm
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`long in the finished product (Ex-2161 at 3)
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` (Ex-2141 at 30)
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`
`
` (id.).
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`These notable differences in pushwire geometry and termination account for
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`significant performance differences, as published in the Telescope Product
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`Brochure. Ex-2071 at 9.
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`19. The termination end of the pushwire is critically different for the two
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`devices. Telescope employs a tapered distal pushwire profile, which is fused to a
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`spade-shaped marker band as shown below.
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`Ex-2071 at 16, 19. The tapered profile interfaces with the device entry port,
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`providing port stability while enhancing device flexibility.
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`20. Telescope’s Trueflex™ soft polymer tip (shown below) is a unique
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`design that exhibits a much lower compression force than Version 3 of GuideLiner.
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`Ex-2071 at 12-13.
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`21. As shown above and below, Telescope’s Truflex™ tip differs from
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`that employed on Version 3 of GuideLiner in both material characteristics and
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`
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`geometry.
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`Ex-2071 at 28.
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`22. As can be seen above, Telescope also employs a different coil pitch.
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` (Ex-2141 at 46), is
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`less than the pitch employed by Telescope.
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`23. Telescope employs a different coating than Version 3 of GuideLiner.
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`Telescope employs a hydrophilic coating that contributes to the device’s
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`deliverability. Version 3 of GuideLiner, on the other hand, employs a silicone
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`coating. See Ex-2071 at 26.
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`24. The entry ports, for inserted therapeutic devices, are substantially
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`different for the two devices. As even Patent Owner acknowledges, “GuideLiner
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`[(Version 3)] has a longer side opening with a third inclined region between the
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`two incline regions.” Telescope employs a short, 4 cm polymer on ramp, with the
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`very tapered pushwire’s distal segment embedded in the polymer. The push wire is
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`terminated distally via a fusion to a spade-shaped marker band, and the entry port
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`has a sculpted geometry. GuideLiner, on the other hand, employs, as described
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`earlier, a very different (embedded) push wire geometry and distal termination, in a
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`17 cm long “half pipe,” apparently fabricated from polyimide, and its entry port is
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`an abrupt 45 degree angular cut at its “collar transition.”
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`25. None of the above product differences are “small” or “insubstantial to
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`the operation of the devices,” as Mr. Keith argues. To the contrary, the product
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`differences directly affect pushability, deliverability, and overall handling of the
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`device—fundamental aspects of a guide extension catheter.
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`26. Mr. Keith also refers to Medtronic’s 510(k) premarket notification,
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`and Medtronic’s necessary showing of substantial equivalence to receive
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`premarket approval. I also understand that Patent Owner points to that approval to
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`suggest that Medtronic copied the Teleflex device. Such a logical leap is
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`unfounded, and it appears that both Mr. Keith and I agree that the finding of
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`substantial equivalence for FDA 510(k) does not indicate that an approved product
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`was copied from an identified predicate device. See, e.g., Ex-1077 at 22:3-20.
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`VI. Conclusion
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`27.
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`In signing this declaration, I understand that the declaration will be
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`filed as evidence in the contested cases before the Patent Trial and Appeal Board of
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`the United States Patent and Trademark Office. I acknowledge that I may be
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`subject to cross-examination in this case and that cross-examination will take place
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`within the United States. If cross-examination is required of me, I will appear for
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`cross-examination within the United States during the time allotted for cross-
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`examination.
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`28.
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`I declare that all statements made herein of my knowledge are true,
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`and that all statements made on information and belief are believed to be true, and
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`that these statements Were made with the knowledge that willful false statements
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`and the like so made are punishable by fine or imprisonment, or both, under
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`Section IOOI ofTitle l8 of‘the United States Code.
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`Dated: December 21. 2020
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`By:
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`Paul Zalesky, Ph D.
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`55...
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`EXHIBIT 1
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`EXHIBIT 1
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`Paul J Zalesky, PhD
`124 Gilbert Stuart Dr mobile: 714-585-2423
`East Greenwich, RI 02818 e-mail : PaulJZalesky@gmail.com
`
`
`
` Summary of Experience: New Product Design, Development, Test & Evaluation, and
` Commercialization of Medical Specialty Products
`
`June 2012 to Present: Consultant to multiple medical technology companies; Contract
`CEO for Envisage Medical to develop the Product Development program and raise
`capital with Research Triangle Institute for a real-time image guidance of structural and
`rhythm heart procedures; acting VP Bus Dev for Israeli percutaneous mitral valve,
`management of development with clinical/regulatory strategy; acting CEO for Device
`Sanitation start-up emphasizing design, development, and commercialization; Expert
`Consultant or Witness to attorney clients and private companies, emphasizing underlying
`medical technology, associated patent validity or infringement, patient injury and
`associated company liability; medical device product development and
`commercialization – all aspects.
`
`Mar 2011 to June 2012: Interim CEO, Keystone Heart, Inc.: Product Design &
`Development, pre-clinical, and clinical study, regulatory submission planning and
`execution for cerebral protection during heart valve repair, in collaboration with
`international CV Surgeons and Cardiologists. Direct management of Clinical Research
`Org and Regulatory personnel towards CE Mark and FDA submissions as part of
`managing all operations.
`
`Feb 2009 to Mar 2011: Consultant, SVMI, Inc., Accumed, Inc, other start-ups and
`Investment Institutions: Product Development plans, Business Development, Financing,
`FDA and other regulatory body strategy planning, and Intellectual Property Planning and
`protection. Perform technical due diligence on novel medical technologies towards
`financial institution investing.
`
`June 2007 to Feb 2009: Vice President, R&D, Volcano Corporation (now Philips)
`Manage all aspects of Product Development, New Technology, and Intellectual Property
`for this public company with revenues exceeding $ 200 MM in Interventional
`Cardiology; produce numerous pre-market document packages for FDA review and
`dialog
`
`Sept 2004 to Present: Consultant, Board Member, Consulting Expert:
`Round Table Group Scholar program; Consulting Expert Witness; Medical Specialty
`Consultant: advise legal counsel, representing BSC, on multiple patent-related and
`technical and practical aspects.
`
` The Battelle Institute: advise on key organization changes and recommended practices.
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` IVIT, Inc.: acting CEO for a Vascular Access company developing technology for
`chronic hemodialysis patients, emphasizing design for least invasive vascular procedures
`and fast regulatory approval path
`
` CryoCath, Inc.: mentor VP R&D and technical staff for an electrophysiology /
`cardiology company seeking fast time-to-market for devices for least invasive treatment
`of cardiac arrhythmias, with emphasis on atrial fibrillation (subsequently acquired by
`Medtronic).
`
` Biovention, Inc.: direct, via Board position, strategy and product development path for
`this novel, heparin-additive, drug-eluting coronary stent company.
`
` Multiple Companies, Investors and Legal Counsel: analyze and advise, in consulting
`capacity, on multiple Product Development programs for wireless cardiovascular
`implants, in vitro diagnostics, aorta implants for aneurysm treatment, non-vascular
`applications of intravascular imaging, and gastroenterological least invasive therapies;
`enable specialized contract developers / manufacturers to drive selected aspects of
`product development for expediency; collaborate with key consultants and employees on
`clinical & regulatory strategies and plans; provide expert consulting for broad-based
`health care institutions and retained legal counsel.
`
`Sept 2003 to April 2005: President & CEO, LumeRx, Inc.: managed all aspects of this
`development stage company focused on light-based therapy in Gastroenterology, with
`emphasis on design and development of therapeutic product; raised $ 7 MM private
`equity financing; recruited and managed key technical staff , consultants and contract
`organizations for Clinical/Regulatory/Quality and Marketing.
`
`August 2003 to December 2006: Consultant CTO, TherOx, Inc.: consulting continuity
`with emphasis on new product development, business development, new financing
`support, and clinical/regulatory strategies for this multiple opportunity company;
`continued Board of Directors activities; manage focused development programs for
`interventional cardiology, cardiovascular surgery, cancer therapy, wound and skin care,
`and GI therapies.
`
`May 2001 to August 2003: Chief Technical Officer, TherOx, Inc.: identified and
`managed multiple cardiovascular business opportunities, as well as core product
`development and manufacturing, with associated novel designs and development paths,
`emphasizing CV Surgery and intra-PTCA alternatives for hyperbaric Oxygenation
`solution technology, specialty wound care therapy, and selected oncology therapies using
`vascular administration; managed all aspects of Intellectual Property.
`
`June 1994 to May 2001: President and Co-founder, TherOx, Inc.: managed all Product
`Development and operating aspects of this start-up, integrating a hardware/software
`bedside system with disposable catheters, focusing on 1)Acute MI, 2) skin & wound care,
`3) cancer therapy; raised more than $ 52 MM in private capital with KPCB as lead
`investor; recruited initial 45 employees in all operating functions, achieved multiple FDA
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`and CE Mark approvals, established clean room manufacturing of disposables and
`electromechanical control + delivery systems, directed extensive, multi-phase clinical
`studies in US and Europe, established and maintained opinion-leading SAB, and
`recruited key international technology consultants for breakthrough developments;
`directed development and management of all intellectual property (primarily patents).
`
`May 1991 to June 1994: VP R&D, Baxter Bentley: managed all product development,
`advanced manufacturing, clinical, and related technical support aspects for this
`cardiopulmonary bypass company with $ 150 MM annual revenue; served as group R&D
`and strategic planning representative for all Cardiovascular Group divisions with $ 900
`MM annual revenue base to enable key growth and diversification strategies, with
`emphasis on interventional cardiology; coordinated use of selected Baxter corporate
`capabilities to achieve operating efficiencies; interacted with FDA on critical programs.
`
`May 1986 to March 1990: President & Co-founder, InterTherapy, Inc.: managed all
`aspects of this start-up focused on the design and development of intracoronary
`ultrasound for interventional cardiology; raised more than $ 11 MM venture capital;
`organized SAB and Clinical Investigator array with opinion-leading Interventional
`Cardiologists in the US and Europe; accomplished rapid FDA approval for marketing,
`ISO certification, and aggressive early marketing with pilot in-house manufacturing
`capability; managed Intellectual Property development.
`(was merged with CVIS, then acquired by BSC).
`
`Previous experience included Executive R&D management positions with Johnson &
`Johnson, Edwards Labs, and Meadox Medicals, and a Special Expert position for the
`National Institutes of Health. Additionally, served 3 years of active duty as a Captain in
`the USAF, performing cardiopulmonary research with human subjects for development
`of life support systems for high performance aircraft.
`
`
`
`
`Education
`
`PhD, Univ. of Michigan, Biomedical Engineering - NIH pre-doctoral fellow
`M.S., Univ. of Michigan, Aerospace Engineering – NSF fellow
`B.S., Univ. of Notre Dame, Aerospace Engineering – USAF Scholarship
`
`Publications and Patents
`
`Lead or co-author of approximately 20 articles in medical and research journals, encompassing
`cardiovascular technology and devices, bench and animal model tests on new technologies for
`heart-related diagnosis and therapy, and clinical (patient) studies on new devices and procedures.
`
`
`
`Representative Publications:
`
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`“Intravascular Ultrasonic imaging”, Texas Heart Institute Journal, 1990
`
`“Intravascular Ultrasound imaging of Human Coronary Arteries In Vivo: Analysis of Tissue
`Characterization with Comparison to In Vitro Histological Specimens”, Circulation, 1991
`
`“A New Bioabsorbable Intravascular Stent: In Vitro Assessment of Hemodynamic and
`Morphometric Characteristics:, J of Interv Cardiol, 1992
`
`“Topical Oxygen Emulsion – A Novel Wound Therapy”, Arch Dermatol, 2007
`
`“The effect of a topical Oxygen emulsion on granulation tissue formation in second degree burn
`wound healing”, Ostomy Wound Management, 2004
`
`
`
`Co-inventor on more than 16 US and International patents, encompassing intravascular
`ultrasound, coronary and cerebrovascular catheters and guidewires, electromechanical imaging
`and control systems, next generation cardiopulmonary bypass systems, Oxygen supersaturated
`solutions’ preparation and vascular delivery, and photodynamic therapy devices and systems.
`
`Representative Patents:
`
`US 4,841,977 - 1989 – “Ultra-thin acoustic transducer and balloon catheter using same in
`imaging array subassembly:
`
`US 5,115,814 – 1992 – “Intravascular ultrasonic imaging probe and method of using same”
`
`US 5,976,119 – 1999 – “High pressure perfusion device”
`
`US 6,123,698 – 2000 – “Angioscopy apparatus and methods”
`
`US 6,235,007 – 2001 – “Atraumatic fluid delivery device”
`
`US 6,248,087 – 2001 – “Apparatus for generalized extracorporeal support”
`
`US 6,454,997 – 2002 – “Apparatus for the preparation and delivery of gas-enriched fluids”
`
`US 6,558,501 B2 – 2003 – “Method for forming atraumatic fluid delivery device”
`
`US 6,596,235 B2 – 2003 – “Method for blood oxygenator”
`
`US 6,613,280 – 2005 – “Disposable cartridge for producing gas-enriched fluids”
`
`US 6,974,435 – 2005 – “Method for enriching a bodily fluid with gas”
`
`US 6,676,800 B1 – 2004 – “Methof for preparation and delivery of gas-enriched fluids”
`
`US 6,607,698 B1 – 2003 – “Method for generalized extracorporeal support”
`
`US 7,468,191 B2 – 2008 – “Method of preparing gas delivering perfluorocarbon emulsions with
`non-fluorinated surfactants”
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`US 7,357,937 B2 – 2008 – “Perfluorocarbon emulsion witn non-fluorinated surfactants”
`
`US 7,820,102 – 2010 – “Disposable cartridge for producing gas-enriched fluids”
`
`US 4,899,756 – 1990 – “Ultrasonic imaging probe with zero dead space”
`
`US 7,135,034 – 2006 – “Flexible array”
`
`US 7,261,730 – 2007 – “Phototherapy device and system”
`
`US 7,449,026 – 2008 – Intra-cavity catheters and methods of use”
`
`
`Personal
`
`Married with four children
`
`
`Other
`
`During the past 5 years (2015 – 2020), testified in depositions and court settings regarding
`specialized medical technologies and various aspects of their commercialization. Examples:
`- Multiple appearances in front of arbitration judges regarding a tissue harvesting product,
`its development and commercialization
`- Deposition regarding an algorithm for detecting heart rhythm disturbances
`- Deposition regarding a cardiac pacemaker and reported patient injuries and deaths
`- Court testimony to FTC officials regarding product attributes and performance claims
`
`In addition, I have produced and delivered several formal reports to legal counsel and affected 3rd
`parties (insurance arbiters, for example) regarding serious patient injury resulting from the
`professional use of medical devices.
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