`
`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`
`Petitioners,
`
`v.
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`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner.
`
`
`
`
`DECLARATION OF PAUL ZALESKY SUBMITTED IN SUPPORT OF
`PETITIONERS’ OPPOSITIONS TO PATENT OWNER’S
`MOTIONS TO AMEND
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2020-00126 (U.S. Patent No. 8,048,032)
`IPR2020-00127 (U.S. Patent No. 8,048,032)
`IPR2020-00128 (U.S. Patent No. RE45,380)
`IPR2020-00129 (U.S. Patent No. RE45,380)
`IPR2020-00130 (U.S. Patent No. RE45,380)
`IPR2020-00132 (U.S. Patent No. RE45,760)
`IPR2020-00134 (U.S. Patent No. RE45,760)
`IPR2020-00135 (U.S. Patent No. RE45,776)
`IPR2020-00136 (U.S. Patent No. RE45,776)
`IPR2020-00137 (U.S. Patent No. RE47,379)
`IPR2020-00138 (U.S. Patent No. RE47,379)
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`TABLE OF CONTENTS
`INTRODUCTION ......................................................................................... 1
`I.
`II. QUALIFICATIONS ...................................................................................... 1
`III.
`SCOPE OF WORK........................................................................................ 5
`IV. LEGAL STANDARD: WRITTEN DESCRIPTION .................................. 6
`V.
`THE PERSON OF ORDINARY SKILL IN THE ART ............................. 7
`VI. THE ROOT PATENTS ................................................................................. 7
`A.
`The Root Patents’ Priority Chain .......................................................... 7
`B.
`Summary of the ʼ032 Patent .................................................................. 8
`VII. THE SPECIFICATION DOES NOT DESCRIBE A GUIDE
`EXTENSION CATHETER WITH A SIDE OPENING OUTSIDE
`OF THE SUBSTANTIALLY RIGID PORTION. .....................................12
`A.
`’032 Patent, Substitute Claim 23 (Replaces Claim 1) .........................22
`B.
`’032 Patent, Substitute Claim 24 (Replaces Claim 11) .......................23
`C.
`’760 Patent, Claim 54 (Replaces Claim 37), Claim 55 (Replaces
`Claim 38), and Claim 56 (Replaces Claim 39) ...................................24
`’760 Patent, Claim 58 (Replaces Claim 51) ........................................25
`’776 Patent, Claim 58 (Replaces Claim 27), Claim 59 (Replaces
`Claim 33), and Claim 60 (Replaces Claim 37) ...................................25
`’776 Patent, Claim 61 (Replaces Claim 42), Claim 62 (Replaces
`Claim 43) .............................................................................................26
`’776 Patent, Claim 65 (Replaces Claim 56) ........................................28
`’379 Patent, Claim 46 (Replaces Claim 25), Claim 47 (Replaces
`Claim 29) .............................................................................................29
`’379 Patent, Claim 49 (Replaces Claim 38), Claim 50 (Replaces
`Claim 43), Claim 51 (Replaces Claim 45) ..........................................29
`VIII. MR. KEITH’S OPINIONS .........................................................................30
`IX. CONCLUSION ............................................................................................33
`
`D.
`E.
`
`F.
`
`G.
`H.
`
`I.
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`i
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`I.
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`Introduction
`1.
`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 RE47,379 (the “Root patents”):
`
`IPR2020-00126, -00127, -00128, -00129, -00130, -00132, -00134, -00135, -00136,
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`-00137, and -00138 (“IPRs”).
`
`2.
`
`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
`3.
`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
`
`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
`
`Engineering (Univ. of Michigan), publishing my thesis research on the prediction
`
`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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`1
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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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`2
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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
`
`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 catheterization 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.
`
`In the early ’90s I served as Vice President of 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
`
`associated symposia, including the development of critical devices for treatment of
`
`CAD.
`
`9.
`
`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
`
`3
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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.
`
`10.
`
`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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`4
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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 catheterization lab
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`procedures for device insertion, deployment, use, and removal.
`
`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.
`
`III. Scope of Work
`I have been asked to review the Root patents and Patent Owner’s
`14.
`
`Contingent Motions to Amend the Root patents and to provide my opinion as to
`
`whether the specification supports the substitute claims.
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`5
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`IV. Legal Standard: Written Description
`I have been informed by counsel that a claim is supported by the
`15.
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`written description only when the specification conveys with reasonable clarity to a
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`person of ordinary skill in the art that the inventor(s) had possession of the full
`
`scope of the claimed subject matter as of the effective filing date.
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`16.
`
`I have been informed by counsel that the “possession” inquiry is an
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`objective inquiry into the four corners of the specification from the perspective of a
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`person of ordinary skill in the art, and, based on that inquiry, the specification must
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`understandably describe the invention to that skilled artisan, showing that the
`
`inventor actually invented the invention claimed.
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`17.
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`I have been informed by counsel that an adequate written description
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`does not require that the specification describe the claimed invention using the
`
`same language as the claim, but there is no written description support if the claims
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`are merely obvious in view of the specification. I understand this to mean that the
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`written description inquiry requires a comparison of the claim(s) with what the
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`specification actually discloses, not what the specification might have included
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`based on the knowledge of a person of ordinary skill in the art as of the effective
`
`filing date.
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`6
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`V. The Person of Ordinary Skill in the Art
`I am aware that Medtronic contends that a person of ordinary skill in
`18.
`
`the art (“POSITA”) at the time of the alleged invention would have (a) had a
`
`medical degree; (b) completed a coronary intervention training program; and (c)
`
`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
`
`had access to a POSITA with an engineering degree, and one with an engineering
`
`degree might have had access to one with a medical degree.
`
`VI. The Root Patents
`A. The Root Patents’ Priority Chain
`19. The relevant priority chain of the Root patents is set forth below:
`
`7
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`20. The parent patent is the ’032 patent, filed May 3, 2006. The ’380
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`patent is related to the parent via a divisional chain. The ’760, ’776, and ’379
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`patents are all continuations of the ’380 patent. Thus, I summarize the disclosure of
`
`the Root patents using the family’s parent—the ’032 patent.
`
`Summary of the ʼ032 Patent
`B.
`21. The ’032 patent is titled “Coaxial Guide Catheter for Interventional
`
`Cardiology Procedures.” IPR2020-00126, Ex. 1001. The ’032 patent issued on
`
`November 1, 2011. Id.
`
`22. The ’032 patent describes “catheters used in interventional cardiology
`
`procedures.” Id., 1:7-8. More particularly, the ’032 patent recites a guide extension
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`catheter (referred to in the ʼ032 patent as a “coaxial guide catheter”) that extends
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`through the lumen and beyond the most distal portion of a guide catheter (i.e., into
`
`8
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`the branch artery). Id., Abstract. The specification of the ʼ032 patent further
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`explains that the purported invention is “a system that [is] deliverable through [a]
`
`standard guide catheter[] for providing backup support by providing the ability to
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`effectively create deep seating in the ostium of the coronary artery.” Id., 2:45-49.
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`23. Figure 1 shows guide extension catheter 12, which has a tubular
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`portion that includes a flexible distal tip 16 (pink) and a reinforced portion 18
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`(blue), as well as rigid portion 20 (yellow). Id., 3:27-30, 6:9-12, Fig. 1.
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`Id., Fig. 1 (color and annotations added).
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`24. The ʼ032 patent also describes the transition at or near the rigid
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`portion. In particular, the ʼ032 patent shows a “side opening” (red circle), which
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`may have “inclined slopes.” Id., Figs. 4, 12-16; see also id., 6:41-51, 8:34-43.
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`
`
`9
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`Id., Fig. 4 (color and annotations added; figure inverted to orient figure similarly to
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`
`
`Fig. 1).
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`25. The ’032 patent also describes an embodiment in which the opening is
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`vertical, or perpendicular, to the hemi-tube portion 110. In this embodiment, the
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`rigid portion 110 is described as a “hemi-tube” along its entire length. There is no
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`portion of the rigid portion 110 that includes a full circumference portion. See id.,
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`9:5-41.
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`10
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`Id., Figs. 20-21. Figure 20 shows a plan view of the perpendicular proximal
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`opening embodiment, and Figure 21 shows an elevational view of the
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`perpendicular proximal opening embodiment. Id., 5:64-67.
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`26.
`
`In conjunction with my analysis in the following sections, I reviewed
`
`the following as-filed patent abstracts, figures, specifications, and claims of the
`
`applications in the priority chain:
`
`U.S. Patent No.
`8,048,032
`8,142,413
`8,292,850
`RE45,380
`RE45,760
`RE45,776
`RE47,379
`
`U.S. Patent App. No.
`11/416,629
`12/824,734
`13/359,059
`14/070,161
`14/195,385
`14/195,413
`14/984,273
`
`Patent App. Filing Date
`May 3, 2006
`June 28, 2010
`Jan. 26, 2012
`Nov. 1, 2013
`March 3, 2014
`March 3, 2014
`Dec. 30, 2015
`
`27. The abstracts, figures, and specifications of the originally filed patent
`
`
`
`applications in the table above are substantively identical. For that reason, unless
`
`otherwise noted, I cite the ʼ629 application (Ex. 1842) in my analysis in the
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`following paragraphs. Indeed, I understand that the parties have stipulated that the
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`11
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`patents listed in the table above have substantively identical disclosures.1 Because
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`the figures are substantially identical in the ’629 application and all patent family
`
`members, I may cite to specific patents, where noted.
`
`VII. The specification does not describe a guide extension catheter with a
`side opening outside of the substantially rigid portion.
`28. There is no written description support for a guide extension catheter
`
`with a side opening outside of the substantially rigid portion. The only disclosure
`
`in the ʼ629 application (including in the abstract, figures, specification, and claims)
`
`for a side opening is in the substantially rigid portion.
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`29. The disclosed coaxial guide catheter (guide extension catheter)
`
`includes three portions: “The coaxial guide catheter includes a tip portion, a
`
`reinforced portion, and a substantially rigid portion.” Ex. 1842 at 9.
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`30. The substantially rigid portion may include a cutout portion (side
`
`opening):
`
`Preferably, the rigid portion may be advantageously formed from a
`stainless steel or Nitinol tube. The rigid portion may be joined to the
`braid or coil portion by welding. The rigid portion may include a cutout
`portion and a full circumference portion. For example, the cutout
`portion may include a section where about 45% of the circumference
`of the cylindrical tubular structure has been removed. The cutout
`portion may also include a section where 75-90% of the circumference
`
`1 See, e.g., IPR2020-00126, Paper 38, 2 n.1.
`
`12
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`of the tubular structure has been removed. In one exemplary
`embodiment, the portion having approximately 45% removed may
`extend for approximately 75 cm and the portion having 75-90% of the
`structure removed extends for about 15 cm.
`
`Id. at 9-10 (emphasis added).
`
`31. Describing the coaxial guide catheter “of the present invention,” the
`
`specification provides, “Rigid portion 20 includes first full circumference portion
`
`34, hemicylindrical portion 36, arcuate portion 38, and second full circumference
`
`portion 40.” Id. at 15-16. The specification describes each of these rigid portion
`
`elements:
`
`First full circumference portion 34 is joined to braid or coil
`reinforcement 32. First full circumference portion 34 extends for a
`relatively short distance, for example, .25 cm.
`
`Hemicylindrical portion 36 desirably includes 40% to 70% of the
`circumference of the tube. Hemicylindrical portion 36 may extend, for
`example, approximately 20 to 75 cm in length.
`
`Hemicylindrical portion 36 tapers into arcuate portion 38.
`
`Arcuate portion 38 extends from 25% to 40% of the circumference of
`the tube. Arcuate portion 38 may extend linearly, for example, for about
`15 cm.
`
`13
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`Arcuate portion 38 connects to second full circumference portion 40.
`Second full circumference portion 40 may extend for a short distance,
`for example, approximately 3 cm.
`
`Id. at 16.
`32. Patent Owner identified this section of the specification “as disclosing
`
`the structure of the side opening” during prosecution of the ʼ379 patent. Ex. 1908
`
`at 89.
`
`33. Although it does not use the exact phrase “side opening,” the
`
`specification reiterates that the side opening is located in the substantially rigid
`
`portion: “Rigid portion 20 may extend for approximately ninety cm and include
`
`first full circumference portion 34 (approximately .25 cm), hemicylindrical portion
`
`36 (approximately seventy five cm), arcuate portion (approximately fifteen cm)
`
`and second full circumference portion (approximately three cm.)” Ex. 1842 at 17-
`
`18.
`
`34. When a figure shows a side opening, it is in rigid portion 20. For
`
`example, Figure 4 shows rigid portion 20, including hemicylindrical portion 36 and
`
`arcuate portion 38:
`
`14
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`IPR2020-00126, Ex. 1001, Fig. 4 (color and annotations added).2
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`35. Similarly, Figures 12-16 show “view[s] of the rigid portion [20] in
`
`accordance with the present invention.” Ex. 1842 at 14. In each instance, the side
`
`opening is in the substantially rigid portion:
`
`
`
`
`
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`2 I cite the figures in the issued patents, but I note that they are substantively
`
`identical to the figures filed with the ʼ629 application.
`
`15
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`IPR2020-00126, Ex. 1001, Figs. 12-16 (color and annotations added).
`
`36.
`
`In reference to Figures 12-16, the ʼ629 application states:
`
`In an embodiment depicted in FIGS. 12-15 [sic], rigid portion [20]
`includes full circumference portion 80, greater than 180° portion 82,
`and less than 180° portion 84. Greater than 180° portion 82 may, for
`example, include structure forming approximately 300° of the
`circumference of the cylinder. Less than 180° portion may include, for
`example, structure forming approximately 90° of the circumference of
`a cylinder. Greater than 180° portion 82 may extend approximately 22-
`25 inches. Greater than 180° portion 82 holds tapered inner catheter 14
`within rigid portion 20.
`
`Ex. 1842 at 20.
`
`37. The original claims recited in the ʼ629 application also describe and
`
`limit the side opening to the substantially rigid portion of the guide extension
`
`catheter. Original independent claim 1 claimed a coaxial guide catheter “having a
`
`second lumen and a flexible distal tip portion, a reinforced portion proximal to the
`
`distal tip portion, and a substantially rigid portion proximal to the reinforced
`
`portion, the substantially rigid portion having an opening along a side thereof.” Id.
`
`at 38 (claim 1) (emphasis added).
`
`38. Original dependent claim 4 added: “further comprising selecting the
`
`substantially rigid portion of the coaxial guide catheter such that it comprises a
`
`16
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`cylindrical portion and a partially cylindrical portion defining the opening along a
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`side thereof.” Id. at 39 (claim 4).
`
`39. Original independent claim 8 claimed a coaxial guide catheter
`
`including “a flexible distal tip portion; a reinforced portion proximal to the flexible
`
`distal tip portion; and a substantially rigid portion proximal to the reinforced
`
`portion, the substantially rigid portion including a partially cylindrical portion
`
`defining an opening along a side thereof, the opening extending substantially along
`
`at least a portion of a length of the rigid portion.” Id. at 40-41 (claim 8) (emphasis
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`added).
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`40. Original independent claim 17 claimed a kit with a coaxial guide
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`catheter including “a flexible distal tip portion; a reinforced portion proximal to the
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`flexible distal tip portion; and a substantially rigid portion proximal to the
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`reinforced portion, the substantially rigid portion including a short cylindrical
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`portion and a partially cylindrical portion defining an opening along a side thereof,
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`the opening extending substantially along a majority of a length of the rigid
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`portion.” Id. at 43 (claim 17) (emphasis added).
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`41.
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`I note that the original claims of the ʼ629 application exclusively
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`recite the side opening in the substantially rigid portion. It was not until the filing
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`of the ʼ059 application (issued as the ʼ850 patent), on January 26, 2012, that
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`17
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`Applicant included claims with a side opening in a portion outside of the
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`substantially rigid portion. IPR2020-00126, Ex. 1002, 27 (claim 3).3
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`42. Further, during prosecution of the ʼ379 patent, the Patent Office
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`agreed that the specification provided no written description support for a side
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`opening other than in the rigid portion. Then-pending claims recited:
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`26. (New) The method of claim 25, further comprising providing a
`segment defining a side opening and positioning the segment proximal
`of the proximal end portion of the reinforced segment, the side opening
`extending for a distance along a longitudinal axis of the segment and
`accessible from a longitudinal side defined transverse to the
`longitudinal axis.
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`38. (New) A method of forming a device adapted for use with a guide
`catheter having a lumen, the method comprising: . . . providing a
`segment defining a side opening extending for a distance along a
`longitudinal axis of the device and accessible from a longitudinal side,
`defined transverse to the longitudinal axis, to receive a balloon catheter
`or stent; and arranging, in a proximal to distal direction, the
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`3 See also IPR2020-00127, Ex. 1402; IPR2020-00128, Ex. 1002; IPR2020-00129,
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`Ex. 1202; IPR2020-00130, Ex. 1402; IPR2020-00132, Ex. 1002; IPR2020-00134,
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`Ex. 1602; IPR2020-00135, Ex. 1002; IPR2020-00136, Ex. 1402; IPR2020-00137,
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`Ex. 1002; IPR2020-00138, Ex. 1202.
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`18
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`substantially rigid segment, the segment defining the side opening, the
`reinforced segment, and the tip segment.
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`Ex. 1908 at 11, 13 (emphasis added).
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`43. The Patent Office rejected the claims:
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`Claims 25-45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-
`AIA), first paragraph, as failing to comply with the written description
`requirement. The claim(s) contains subject matter which was not
`described in the specification in such a way as to reasonably convey to
`one skilled in the relevant art that the inventor or a joint inventor, or for
`pre-AIA the inventor(s), at the time the application was filed, had
`possession of the claimed invention.
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`Id. at 41. The Patent Office explained further:
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`Regarding claims 26 and 38, the new claim language of “a segment
`having/defining a side opening” does not have support in the
`specification of the ’850 patent or the ’059 application resulting in the
`patent. The ’850 patent is very clear that the side opening, i.e. the
`opening in the catheter wall made from “first full circumference portion
`34, hemicylindrical portion 36 and arcuate portion 38” is part of rigid
`portion 20 and not its own segment apart from rigid portion. See the
`’850 patent col. 6, 11. 50-65. Claim 26 further places the newly claimed
`“segment” “proximal of the proximal end portion of the reinforced
`segment.” However, the substantially rigid segment is located proximal
`of the proximal end portion of the reinforced segment. Claim 38
`identifies the segment defining the side opening as a completely
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`19
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`different structure from the rigid portion which is contrary to the ’850
`patent specification. Appropriate correction is required.
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`Id. at 41-42 (emphasis added). As the Patent Office explained, placing the side
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`opening in a portion other than the rigid portion “is contrary to the ʼ850 patent
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`specification.” Id. Because the specifications in the priority chain are substantively
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`identical, placing the side opening outside of the substantially rigid portion is
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`contrary to the teachings of any specification in the priority chain.
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`44. Patent Owner did not disagree with the Examiner’s assessment of
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`what the specification of the ʼ850 patent (or any other specification in the priority
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`chain) taught and instead amended the then-pending claims to overcome the
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`rejection:
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`With respect to claims 26 and 38, the Examiner asserts that the catheter
`wall opening described in the specification is not “its own segment
`apart from the rigid portion.” Office Action, p. 12. Without acquiescing
`to this assertion, and solely to advance prosecution, claim 25
`(incorporating the relevant recitations of claim 26) and claim 38 have
`been amended to recite “defining a side opening portion, including
`forming, in a proximal to distal direction, an arcuate cross-sectional
`shape and a hemicylindrical cross-sectional shape.”
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`Id. at 73.
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`45.
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`Further, later in the prosecution of the ʼ379 patent, the following
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`statements were provided in the Applicant-Initiated Interview Summary:
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`20
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`“[A]ttention was drawn to col. 6, ll. 50-68 of the subject patent as disclosing the
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`structure of the side opening.” Id. at 89. This corresponds with the following
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`statement in the ʼ850 specification:
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`Rigid portion 20 includes first full circumference portion 34,
`hemicylindrical portion 36, arcuate portion 38, and second full
`circumference portion 40.
`
`First full circumference portion 34 is joined to braid or coil
`reinforcement 32. First full circumference portion 34 extends for a
`relatively short distance, for example, .25 cm.
`
`Hemicylindrical portion 36 desirably includes 40% to 70% of the
`circumference of the tube. Hemicylindrical portion 36 may extend, for
`example, approximately 20 to 75 cm in length.
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`Hemicylindrical portion 36 tapers into arcuate portion 38.
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`Arcuate portion 38 extends from 25% to 40% of the circumference of
`the tube. Arcuate portion 38 may extend linearly, for example, for about
`15 cm.
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`Arcuate portion 38 connects to second full circumference portion 40.
`Second full circumference portion 40 may extend for a short distance,
`for example, approximately 3 cm.
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`IPR2020-00126, Ex. 1002, 17-18; see also Ex. 1842 at 16 (’629 application
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`using identical language). In other words, the Patent Owner cited to the
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`teaching that the side opening is in the rigid portion 20. In the same
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`21
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`Applicant-Initiated Interview Summary, the Applicant’s representative stated
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`that this portion of the specification “would be most helpful in defining the
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`invention over the prior art.” Ex. 1908 at 89.
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`46. Accordingly, it is my opinion that a POSITA, reviewing the original
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`ʼ629 application and the subsequently filed specifications, would not understand
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`that the inventors were in possession of a guide extension catheter having a side
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`opening outside of the substantially rigid segment. Stated another way, there is no
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`patent specification in the priority chain that provides written description support
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`for a side opening outside of the substantially rigid segment.
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`47.
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`In the following paragraphs, I set forth my analysis for each substitute
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`claim where Patent Owner tries to claim a side opening separate from the
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`substantially rigid portion. As detailed above, it is my opinion