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.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`
`
`Case IPR2020-00135
`Patent RE 45,776E
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`DECLARATION OF PETER T. KEITH
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`TABLE OF CONTENTS
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`Page
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`PERSONAL BACKGROUND ....................................................................... 1
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`
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`I.
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`II. MATERIALS CONSIDERED ........................................................................ 4
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`III. LEGAL STANDARDS ................................................................................... 6
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`A. Claim Construction................................................................................ 6
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`B. Anticipation ........................................................................................... 7
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`C. Obviousness ........................................................................................... 7
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`IV. SCOPE OF OPINIONS ................................................................................... 9
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART .......................................... 9
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`VI. OVERVIEW OF THE TECHNOLOGY OF THE ‘776 PATENT ............... 10
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`A. Background on the Technology: Coronary Catheters and Heart
`Disease ................................................................................................. 10
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`B.
`
`C.
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`Background on the Technology: Teleflex’s GuideLiner Devices ...... 38
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`The GuideLiner In Use ........................................................................ 51
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`VII. THE ‘776 PATENT ....................................................................................... 52
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`VIII. CLAIM CONSTRUCTION .......................................................................... 58
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`A.
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`“Interventional cardiology device(s)” ................................................ 59
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`B.
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`“The segment defining the angled proximal end of the partially
`cylindrical opening includes at least one inclined region that tapers
`into a non-inclined region” ................................................................. 63
`IX. THE REFERENCES PETITIONER’S EXPERTS RELY ON ..................... 65
`
`ii
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`

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`A.
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`Itou (Ex-1007) .................................................................................... 65
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`B. Kataishi (Ex-1025) ............................................................................. 67
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`C.
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`D.
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`Ressemann (Ex-1008) ........................................................................ 70
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`Enger (Ex-1050) ................................................................................. 80
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`X.
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`THE EVIDENCE DR. BRECKER CITES DOES NOT SHOW THAT
`ITOU’S SUCTION CATHETER HAS A SEGMENT CONFIGURED TO
`RECEIVE INTERVENTIONAL CARDIOLOGY DEVICES
`THERETHROUGH WHEN POSITIONED WITHIN THE GUIDE
`CATHETER (GROUND 1, CLAIM 25) ...................................................... 84
`XI. THE LUMEN OF ITOU IS NOT CONFIGURED TO RECEIVE A STENT
`AND BALLOON CATHETER (GROUND 1, CLAIM 32) ........................ 87
`XII. ITOU DOES NOT HAVE A SEGMENT DEFINING THE ANGLED
`PROXIMAL END OF THE PARTIALLY CYLINDRICAL OPENING
`THAT INCLUDES AN INCLINED REGION THAT TAPERS INTO A
`NON-INCLINED REGION (GROUND 1, CLAIM 36) ............................. 89
`XIII. A POSITA WOULD NOT BE MOTIVATED TO COMBINE THE
`DISTAL END OF KATAISHI’S CATHETER WITH THE PROXIMAL
`TIP OF ITOU’S CATHETER (GROUND 3, CLAIMS 36-37, 52-56) ....... 90
`XIV. IT WOULD NOT HAVE BEEN OBVIOUS TO COMBINE ITOU AND
`RESSEMANN IN THE MANNER ASSERTED BY DR. BRECKER AND
`DR. HILLSTEAD (GROUND 4, CLAIMS 32, 36-37, 46, 52-56) .............. 95
`Itou and Ressemann Are Designed for Different Purposes, and a
`A.
`POSITA Would Not Look to Ressemann to Modify Itou .................. 95
`It Would Not Have Been Obvious to a POSITA to Extract
`Ressemann’s Support Collar and Incorporate It Into Itou’s Proximal
`Opening as Proposed by Dr. Brecker and Dr. Hillstead ..................... 98
`The “Motivations” the Petitioner’s Experts Identify Would Not
`1.
`Motivate a POSITA to Combine Ressemann’s Collar 2141 with
`Itou in the Precise Way Asserted by Dr. Brecker and Dr.
`Hillstead .................................................................................. 105
`Even a Combination of Itou with Ressemann’s Collar Would
`Not Result in the Claimed Elements ....................................... 111
`
`B.
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`2.
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`iii
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`XV. COMBINING RESSEMANN’S SUPPORT COLLAR WITH ITOU’S
`PROXIMAL TIP DOES NOT RESULT IN A LUMEN HAVING A
`“UNIFORM CROSS-SECTIONAL INNER DIAMETER THAT IS NOT
`MORE THAN ONE FRENCH SIZE SMALLER” THAN THE INNER
`DIAMETER OF THE GUIDE CATHETER .............................................. 115
`XVI. IT WOULD NOT HAVE BEEN OBVIOUS TO COMBINE ITOU’S
`SUCTION CATHETER WITH THE INTERMEDIATE SEGMENT OF
`ENGER’S BALLOON CATHETER (GROUND 5, CLAIMS 52-56) ...... 118
`Enger Does Not Disclose a Partially Cylindrical Opening Having at
`A.
`Least Two Inclined Regions .............................................................. 118
`B. A Person of Ordinary Skill in the Art Would Not Be Motivated to
`Combine Itou and Enger ................................................................... 119
`XVII. OBJECTIVE INDICIA OF NONOBVIOUSNESS .................................... 122
`A. GuideLiner Embodies Claims 36, 52 and 53 of the ‘776 Patent ...... 123
`The Guidezilla (Boston Scientific), Boosting Catheter (QXMédical)
`B.
`and Telescope (Medtronic) Products Are All Substantially Similar to
`Teleflex’s Patented GuideLiner, Including the Complex Side Opening
`of Claims 36, 52, and 53 ................................................................... 124
`Boston Scientific Corp.’s Guidezilla Catheter ........................ 125
`i.
`ii.
`QXMédical’s Boosting Catheter ............................................. 131
`iii. Medtronic’s Telescope Product .............................................. 135
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`iv
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`I, Peter Keith, hereby declare and state as follows:
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`
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`I have been retained by the owner of U.S. Patent No. RE45,776 (“the
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`’776 patent”), whom I will refer to in this declaration as “Teleflex,” to provide my
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`independent expert opinions in this matter. I understand that a petition for inter
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`partes review (“IPR”) has been filed against certain claims of the ’776 patent. The
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`following provides my opinions in this matter.
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`I.
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`PERSONAL BACKGROUND
`I summarize my educational background and career history in the
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`following paragraphs. My complete qualifications are provided in my curriculum
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`vitae, which is attached to this declaration as Appendix A.
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`
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`I received a Bachelor of Science degree in mechanical engineering
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`with High Distinction from the University of Minnesota in 1987. During my
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`undergraduate training, I began working as an engineering intern in the research
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`and development (R&D) department at SCIMED, which was later acquired by
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`Boston Scientific Corporation. I joined SCIMED full-time after graduation, and I
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`remained with the company until 1996. During this time I rose from engineering
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`intern to full-time R&D engineer to Director of R&D. Throughout my various
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`roles at SCIMED, the focus of my work was on medical devices in the field of
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`interventional cardiology, particularly catheter design.
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`1
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`Since 1997, I have served as an independent consultant for early stage
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`medical device companies in the areas of product design and intellectual property
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`development. Many of my consulting clients and/or the products they developed
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`with my assistance were subsequently acquired by large medical technology
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`companies, including St. Jude Medical/Abbott, Johnson & Johnson, Teleflex,
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`Edwards Lifesciences and LivaNova. A number of the products I have consulted
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`on have been in the field of interventional cardiology, particularly catheters.
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`
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`In addition to my work as an independent consultant, since 2000 I
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`have engaged in a number of entrepreneurial ventures in the field of medical
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`devices. In many of these ventures, I held chief responsibility for product design
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`and development. Several of these products have been in the area of interventional
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`cardiology. I have also done considerable work outside the area of interventional
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`cardiology, including in treatments for orthopedics for extremities such as feet and
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`ankles and treatment of spinal disorders. In 2006, I co-founded Entellus Medical, a
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`company focused on catheter-based treatments for chronic sinusitis. As Chief
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`Technology Officer, I led the product development and research teams. Entellus
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`successfully commercialized a series of ground-breaking products developed under
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`my leadership. Entellus went public in 2015, and was acquired by Stryker in 2018
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`for over $600 million.
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`2
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`Between my work at SCIMED, my independent consulting, and my
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`entrepreneurial ventures, I have been named as an inventor on over 140 issued U.S.
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`patents, as well as many corresponding patents in foreign countries. Numerous
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`patent applications on which I am a named inventor are still pending. Many of
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`these patents concern catheters.
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`
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`I have been informed that the patent at issue in this inter partes review
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`trial is one of a family of five patents that the Petitioner has challenged: U.S. Patent
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`Nos. 8,048,032; RE45,380; RE45,760; RE45,776; and RE47,379. I refer to these
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`as the “GuideLiner patents.”
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`
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`I have prior experience with patent litigation involving the technology
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`at issue and the GuideLiner patents. Among other things, I provided expert
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`analysis on behalf of Teleflex in the case of QXMédical, LLC v. Vascular Solutions
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`LLC, et al., No. 0:17-cv-01969 (D. Minn.) (the QXM case). In the QXM case,
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`among the patents asserted were four of the five GuideLiner patents at issue in
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`these IPRs: U.S. Patent Nos. 8,048,032; RE45,380; RE45,760; and RE45,776.
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`U.S. Patent No. RE47,379 had not yet issued when the QXM case was filed, but it
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`is in the same family as the other four patents listed above that were asserted in the
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`QXM case.
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`
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`I have also provided expert opinions concerning all five GuideLiner
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`patents at issue in these proceedings on behalf of Teleflex in the case of Vascular
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`3
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`

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`Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.). Those
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`opinions were provided in connection with Teleflex’s Motion for Preliminary
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`Injunction.
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`
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`I am being compensated at $525 per hour for my time, my standard
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`rate for this type of consulting activity. My compensation is not contingent on the
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`results of these or any other legal proceedings.
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`II. MATERIALS CONSIDERED
`In writing this declaration, I have considered my own knowledge and
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`experience, including my work experience in designing medical devices including
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`catheters and my experience in working with others involved in the field of
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`interventional cardiology devices, including medical doctors working as
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`interventional cardiologists. I have also considered the information that a person
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`of ordinary skill in the art (“POSITA”) would have been aware of as of the date of
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`invention, including the documents I discuss in this declaration.
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`
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`I have also reviewed the patent at issue in this inter partes review trial
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`and its file history, as well as the other four GuideLiner patents and their file
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`histories.
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`
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`I have reviewed the Petitions filed in each of the IPR2020-00126,
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`00127, 00128, 00129, 00130, 00132, 00134, 00135, 00136, 00137, and 00138
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`matters.
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`4
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`I have also reviewed the declarations of Dr. Brecker and Dr. Hillstead
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`that accompanied the Petitions filed in each of the IPR2020-00126, 00127, 00128,
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`00129, 00130, 00132, 00134, 00135, 00136, 00137, and 00138 matters. Dr.
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`Brecker’s declarations were labeled with an exhibit number having the form “Ex-
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`1_05”, and Dr. Hillstead’s declarations were labeled with an exhibit number
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`having the form “Ex-1_42.”
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`
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`I have also reviewed the documents (including the patents, patent
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`publications, and articles) cited in Dr. Brecker and Dr. Hillstead’s declarations.
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`I have reviewed the Institution Decisions issued by the Patent Trial
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`and Appeal Board in each of the IPR2020-00126, 00127, 00128, 00129, 00130,
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`00132, 00134, 00135, 00136, 00137, and 00138 matters.
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`
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`I have also reviewed the additional documents and materials I cite or
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`discuss in this declaration.
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`I am also familiar with (and have inspected) the GuideLiner devices I
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`discuss in this declaration, as well as the Boston Scientific Guidezilla guide
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`extension catheter, the QXM Boosting Catheter, and the Medtronic Telescope
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`guide extension catheter. I have also performed testing on the GuideLiner, QXM
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`and Medtronic guide extension catheters.
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`5
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`III. LEGAL STANDARDS
`I am not an attorney and I have not independently researched the law
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`on patentability. I have been informed by counsel of the legal standards below.
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` Claim Construction
`I understand that patent claims are to be interpreted in view of a
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`patent’s specification and prosecution history. I understand that claim construction
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`starts with the plain language of the claims as understood by a person having
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`ordinary skill in the art at the time the patent was filed.
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`I understand that a patent may be its own lexicographer, so long as the
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`definition of a specific term is clearly set forth in the specification and it is clear
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`the inventor intended to define the term.
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`
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`I understand that certain claim language may be considered “means-
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`plus-function” claim language, and in such a case that the claim covers the
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`structure disclosed in the specification for performing the claimed function and
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`equivalents thereof. I understand that something may be considered a structural
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`equivalent of a “means-plus-function” limitation when the structure performs the
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`claimed function in substantially the same way to achieve substantially the same
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`result as the corresponding structure described in the specification.
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`
`6
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`

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` Anticipation
`I understand that a claim is invalid as anticipated if a single prior art
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`reference discloses each and every limitation of the claimed invention.
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`I understand that a reference may be anticipatory regardless of
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`whether the prior art and the claimed invention are directed to achieving the same
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`purpose, if it contains the claim elements as claimed and would inherently provide
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`any claimed function.
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`I understand that a prior art reference may anticipate a claim without
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`expressly disclosing a feature of the claimed invention if that missing feature is
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`necessarily present, or inherent, in the single anticipating reference.
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`I understand that inherency requires more than a probability or
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`possibility that a claimed feature is present in the prior art, but rather that the
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`feature or characteristic is a necessary part of the prior art. I also understand that a
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`POSITA does not necessarily need to recognize the inherency at the time of
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`purported invention.
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` Obviousness
`I understand that obviousness is determined based on (1) the scope
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`and content of the prior art; (2) the differences between the claims and the prior art;
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`(3) the level of ordinary skill in the art; and (4) objective indicia of
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`nonobviousness.
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`7
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`
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`I understand that there must be a reason to modify a single prior art
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`reference, or to combine multiple references, to achieve the claimed invention. I
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`understand that this motivation may come from a teaching, suggestion, or
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`motivation to combine. I also understand that a specific teaching, suggestion, or
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`motivation is not required.
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`
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`I also understand that objective indicators of non-obviousness
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`(sometimes referred to as “secondary considerations”) must be considered in
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`evaluating obviousness, including commercial success of the claimed invention,
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`whether others copied the invention, a long-felt but unmet need in a particular
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`industry and whether others in the field praised the invention. I understand that
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`secondary considerations of nonobviousness support a finding of nonobviousness
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`if the evidence of secondary considerations is sufficiently tied to the patented
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`features. Where a patent claims a combination of features, I understand that the
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`evidence of secondary considerations may be tied to the claimed combination as a
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`whole.
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`I understand that, after consideration of all of these factors, a patent is
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`not obvious unless the difference between the subject matter sought to be patented
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`and the prior art are such that the subject matter as a whole would have been
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`obvious at the time the invention was made to a person having ordinary skill in the
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`art to which said subject matter pertains.
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`8
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`IV. SCOPE OF OPINIONS
`I have been asked only to provide my independent opinions and
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`analysis of the issues I specifically discuss in this declaration. I note that the
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`Petition (and the evidence it cites) appears to raise many other issues, but I have
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`not been asked to provide my opinions as to any of those other issues.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
`I understand that the Petitioner and Dr. Brecker have proposed a
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`definition of a POSITA: “a person of ordinary skill in the art (“POSITA”) at the
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`time of the alleged invention would have had (a) a medical degree; (b) completed a
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`coronary intervention training program, and (c) experience working as an
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`interventional cardiologist. Alternatively, a POSITA would have had (a) an
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`undergraduate degree in engineering, such as mechanical or biomedical
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`engineering; and (b) three years of experience designing medical devices,
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`including catheters or catheter-deployable devices. [. . .] Extensive experience and
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`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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`access to a POSITA with an engineering degree, and one with an engineering
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`degree might have access to one with a medical degree.” E.g., Ex-1005, ¶ 31.
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`While I do not necessarily agree with this proposed definition, my opinions below
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`are provided with respect to this definition of a POSITA.
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`9
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`
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`I have an undergraduate degree in mechanical engineering and more
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`than three years designing medical devices, including catheters or catheter-
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`deployable devices. Therefore I meet the definition of a POSITA provided by the
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`Petitioner and Dr. Brecker.
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`
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`I understand that when considering the validity of the claims
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`challenged by the Petitioner, I am to analyze the patents, the prior art, and any
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`other references from the perspective of a POSITA at the time of invention. I
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`understand that this date is no later than May 3, 2006, the date on which the
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`earliest patent application for the family of GuideLiner patents was filed.
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`Therefore when I provide my opinions, I note that they are from the perspective of
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`a POSITA in May 2006. However, I also have reviewed evidence showing that the
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`inventors actually invented the inventions of the GuideLiner at least by August,
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`2005. Given my experience described in this declaration and in my CV, I also am
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`very familiar with the level of skill of a POSITA in the year 2005, and my opinions
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`would be the same if the relevant date of invention is sometime in 2005, rather
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`than May 2006.
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`VI. OVERVIEW OF THE TECHNOLOGY OF THE ’776 PATENT
` Background on the Technology: Coronary Catheters and Heart
`Disease
` The technology involved in this case pertains to coronary catheter
`
`procedures. These are procedures for treating conditions in the blood vessels of
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`10
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`the heart itself (coronary arteries). More specifically, this case pertains to a
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`specialized catheter device used in some of the more challenging procedures,
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`called a “guide extension catheter.” As a result of my extensive experience in the
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`medical device field, and in particular with catheter technology, I have become
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`very familiar with coronary catheter procedures and the devices used for those
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`procedures. The following paragraphs provide an overview of heart disease,
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`coronary catheters, and coronary catheter procedures that is based on this
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`experience.
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` As the heart is essentially a large, muscular, pumping organ, it
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`requires a lot of oxygenated blood to sustain itself. This blood circulates within the
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`heart muscle via the coronary arteries (see diagram below). Over time, these blood
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`vessels may become diseased (coronary artery disease, “CAD”) resulting in
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`regions of narrowing or occluding. Starting in the 1970s, advances were made in
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`treating this disease with catheter devices advanced into the coronary arteries from
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`relatively accessible arteries in the leg or arm, e.g., the femoral artery in the leg or
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`the radial artery in the arm.
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`11
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`
`
` CAD (also called atherosclerosis or plaque buildup) results in
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`narrowed regions (lesions or stenoses) that can restrict the flow of blood to regions
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`of the heart muscle. (See below—A.) Severe lesions can dramatically restrict the
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`blood flow, starving the muscle of oxygen (ischemia), which can create severe
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`chest pain and significantly limit a patient’s activity and quality of life. If the
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`lesion completely blocks the flow of blood (typically from a subsequent blood clot
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`within the lesion), this can lead to a heart attack (myocardial infarction). (See
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`below—B.) Severe lesions and complete blockages necessitate some sort of
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`treatment to reopen the blocked region and re-establish normal or near normal
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`blood flow. In the case of a complete blockage (myocardial infarction), the patient
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`12
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`

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`may die if the blocked vessel is not re-opened quickly, i.e., within hours of the
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`blockage.
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`
`
` Since at least the early 1990s, the most common treatment for CAD is
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`with catheter devices that dilate the blockage from inside and place a support
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`scaffold (stent) therein. The stent is inserted across the lesion in a collapsed state
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`and then dilated with a balloon-tipped catheter called an angioplasty catheter (see
`
`below). It is therefore critical that these catheter devices are able to be positioned
`
`within the blockage, and positioned quickly, to treat the patient successfully.
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`13
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`

`

`
`
` One of the main pumping chambers of the heart is the left ventricle
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`“LV.” The LV receives the oxygenated blood from the lungs and pumps it to the
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`body via the aorta. The rest of the blood vessels that oxygenate the body are all
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`branches and sub-branches off of the aorta. The very first branches near the
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`beginning of the aorta are the coronary arteries, the left main coronary artery
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`“LM,” and the right coronary artery “RCA.” The openings of these arteries from
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`the aorta are called ostia (singular: ostium). The LM runs for a short length before
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`it branches into two longer arteries that run the rest of the way down the left and
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`posterior sides of the heart: the left anterior descending “LAD” and left circumflex
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`“LCX.” The RCA extends down the right side of the heart. The RCA, LAD, and
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`LCX are considered the three primary coronary arteries. Each of these arteries, in
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`turn, has numerous side branches, which then further branch ultimately into the
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`capillary beds where the actual transfer of oxygen to heart muscle tissue takes
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`14
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`

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`place (see figure below). Most lesions requiring treatment are within these three
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`primary arteries, or occasionally a major branch stemming therefrom.
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`
`
` Beyond the coronary arteries, the aorta has numerous branches and
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`sub-branches as it feeds oxygenated blood to the rest of the body. (See diagram
`
`below—A.) The aortic arch is where the aorta turns and heads inferiorly
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`(descending aorta) towards the legs. One of the branches off the aorta that feeds
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`the arm is the right subclavian artery. A sub-branch of this artery is the radial
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`artery near the wrist. Another branch from the aorta is the iliac artery, which
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`further sub-branches into the femoral artery near the groin. The femoral artery and
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`radial arteries are relatively close to the skin surface, and one or the other is
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`15
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`typically used as the access vessel to gain access to the aorta and the coronary
`
`arteries as will be described below. (See diagram below—B.)
`
`
`
`
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`In the following paragraphs, I will describe a typical coronary catheter
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`treatment procedure. Many variations of the procedure exist, but this description
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`of a typical and common procedure will serve to illustrate the issues pertinent to
`
`the technology in the case at issue.
`
` The treatment of lesions by catheter techniques involves accessing a
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`remote blood vessel, e.g., the femoral artery, via a needle puncture from the skin
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`into the vessel, known as percutaneous access. A series of devices and maneuvers
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`(called the “Seldinger” technique) results in placement of an introducer sheath into
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`this vessel (see below). The introducer sheath is a relatively short tubular access
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`catheter, approximately 20 cm long. Its purpose is primarily to maintain an access
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`pathway into the femoral artery to facilitate the rest of the procedure. A slitted
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`16
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`

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`seal is provided on the back (proximal) end of the sheath to keep blood from
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`exiting. The appropriate sheath size depends on numerous factors, including the
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`sizes of the planned devices to be inserted through the sheath and used for the
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`coronary lesion.
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` Once access is established to the remote artery, a catheter (hollow
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`tube) is advanced through the slitted seal, the sheath, and the aorta into the heart
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`where a “diagnostic” catheterization procedure is performed. This entails injecting
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`an x-ray visible contrast solution through the catheter into the main coronary
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`vessels and one or more of the pumping chambers of the heart. This technique
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`identifies the location of any blockages or narrowings that may require treatment
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`with angioplasty catheters, as well as any defects in the valves that separate the
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`chambers of the heart. Sometimes this diagnostic catheterization procedure is
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`performed as a separate procedure.
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`17
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`

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`
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` After the sheath is placed and the diagnostic procedure is complete, to
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`treat the lesion a device called a guide catheter (also called a “guiding catheter”, or
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`sometimes just a “guide”) is inserted into the sheath and advanced from the
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`femoral artery, up the aorta, and around the aortic arch, with its tip next to or just
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`into the coronary ostium of choice (see figure below). A stiffening wire, usually
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`about 0.035 inches in diameter, is often placed inside the length of the guide
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`catheter to keep some of the distal curves (described below) straight until the curve
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`of the aortic arch is reached. This wire is then removed. The primary purpose of
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`the guide catheter is to provide a stable access route for coronary devices and a
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`lumen for delivery of x-ray contrast fluid for visualizing the vessel and lesion.
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` Guide catheters are more complex than they may appear. They
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`typically have multiple layers and multiple regions of flexibility, stiffer at the
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`proximal end and progressively more flexible towards the distal end. However,
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`they must still be sufficiently rigid to maintain their shape and position relative to
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`the ostium. A PTFE (“Teflon”) lubricious liner extends through the inside of the
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`guide catheter. Embedded in the walls of the guide catheter is a metallic wire braid
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`which facilitates “torquability” by enhancing the torsional stiffness. (See below—
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`A.) Guide catheters also have pre-set curves near the distal tip, to aid in placement
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`within the aortic arch and into the ostium. (See below—B.) There are numerous
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`curve shapes offered by many manufacturers. (See below—C.) The combination
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`of stiffness characteristics, torsional characteristics, and curve shapes aids in the
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`ability to successfully intubate the ostium of a particular individual. Every
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`person’s arch and ostium anatomy is different. Therefore, accessing each ostium
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`can be a challenge—thus the variety of guide catheters available.
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`
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` Guide catheters are available in a range of diameters, which
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`correspond to the introducer sheath inner diameters. Well before 2006, guide
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`catheter sizes were often referred to by the “French” scale. Under a strict
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`mathematical definition, the term “French” refers to 1/3 mm, or 0.0131 inches. I
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`note, however, that when referring to the size difference between the inner
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`diameter of the guide catheter and the inner diameter of the guide extension
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`catheter, the specification of the GuideLiner patents does not use this strict
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`mathematical definition. E.g. Ex-1001 (IPR2020-00126), 3:5-20. This is not
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`unusual or surprising because, as I noted above, guide catheters were typically
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`sized according to their outer diameter, whereas the inner diameter varies
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`depending not just on outer diameter, but also on wall thickness. Therefore, a
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`POSITA would interpret a “one French size” difference consistently with the
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`specification, rather than in accordance with the strict mathematical definition of
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`“French.” Thus, for example, when a guide extension catheter having an internal
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`diameter of at least 0.056 inches is used with a 6 French guide catheter (which
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`would typically have an external diameter of ~0.079 inches and an internal
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`diameter of ~ 0.070-0.071 inches), the guide extension catheter is used with a
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`guide catheter that is one French size different.
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`
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` A device called a hemostatic valve (also sometimes referred to as a
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`hemostasis valve, or a Y-connector or Y-adaptor, which includes a hemostatic
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`valve) is positioned on the proximal end of the guide catheter to prevent bleeding
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`from this catheter (see figure below). The valve can be temporarily opened when
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`devices are passed into the guide catheter. A side arm allows for injection of
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`fluids, such as contrast for periodic x-ray visualization.
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` Through the guide catheter, a small wire called a guidewire is inserted
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`into and through the guide catheter, into the coronary vessel and across the lesion.
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`A guidewire used in coronary applications is typically 0.014 inches in diameter and
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`175 cm long. The primary purpose of the guidewire is to cross the lesion and serve
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`as a “track” over which other devices are guided into the coronary vessel and
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`across the lesion. Guidewires also are more complex than they first appear. They
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`are formed from a solid metal core wire, about 0.014 inches in diameter, typically
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`made of a springy stainless steel. Towards the distal end, the core wire diameter is
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`ground down gradually until the diameter is around 0.001 inches in diameter. This
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`diameter transition zone is about 30 cm long. The proximal part of the guidewire
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`is significantly more rigid than the distal part. Stated differently, the distal end is
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`significantly more flexible than the proximal end. This is important, as the distal
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`end needs to safely navigate the fragile coronary vessel, while the proximal end
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`needs to accurately advance and rotate the distal end within the confines of the
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`guide catheter. Much of the length of the reduced diameter portion is covered in a
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`fine wire coil, which maintains the outer diameter of the guidewire at 0.014 inches
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`(see diagram below) while maintaining its flexibility.
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`
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` To aid in navigating the guidewire through the coronary vasculature, a
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`small “J” bend is often formed at the distal end (see below), and when the
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`guidewire is rotated from the proximal end, the J bend is rotated. The combination
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`of careful rotation and advancement of the guidewire allows it to be steered
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`through the coronary artery and through the lesion. The tip portion is usually
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`advanced to a position several centimeters distal to the lesion, to allow for a more
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`rigid portion of the guidewire to be within the lesion. The positioned guidewire
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`now serves as the track to guide the subsequent dilation or stent delivery catheter
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`to the lesion.
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` With the guidewire in place across the lesion, a balloon catheter or
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`stent delivery catheter can be advanced over the guidewire. In some cases a
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`balloon catheter is advanced through the coronary artery into the lesion and is
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`expanded one or more times to compact the plaque or thrombus