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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`IPR2020-01343
`IPR2020-01344
`Patent RE 46,116
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`DECLARATION OF PETER T. KEITH
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`TABLE OF CONTENTS
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`Page
`I.
`PERSONAL BACKGROUND ....................................................................... 1
`II. MATERIALS CONSIDERED ........................................................................ 4
`III. LEGAL STANDARDS ................................................................................... 6
`A. Claim Construction ............................................................................... 6
`B. Obviousness ........................................................................................... 6
`IV. SCOPE OF OPINIONS ................................................................................... 7
`V.
`PERSON OF ORDINARY SKILL IN THE ART .......................................... 8
`VI. OVERVIEW OF THE TECHNOLOGY OF THE ‘116 PATENT ................. 9
`A. Background on the Technology: Coronary Catheters and Heart
`Disease ................................................................................................... 9
`B.
`Background on the Technology: Teleflex’s GuideLiner Devices ...... 36
`C.
`The GuideLiner In Use ........................................................................ 49
`VII. THE ‘116 PATENT ....................................................................................... 50
`VIII. CLAIM CONSTRUCTION .......................................................................... 57
`IX. THE REFERENCES PETITIONER’S EXPERTS REPLY ON ................... 58
`A.
`Itou (Ex-1007) .................................................................................... 58
`B.
`Ressemann (Ex-1008) ........................................................................ 61
`C. Kontos (Ex-1009) ............................................................................... 72
`D. Kataishi (Ex-1025) ............................................................................. 85
`E.
`Takahashi (Ex-1410) .......................................................................... 87
`F.
`Root (IPR2020-01344, Ex-1512) ....................................................... 89
`ITOU-BASED CHALLENGES (IPR2020-01343 (GROUNDS 2-3)) ........ 89
`A.
`Itou is Not Inherently Capable of Being Used as a Guide Extension
`Catheter for Balloon Catheters or Stents (Grounds 2-3 (Claims 25-40,
`42, 44-48, 52, and 53)) ....................................................................... 89
`1.
`Itou’s Suction Catheter Does Not Have Structure that Is
`Inherently Capable of Advancing a Balloon Catheter or Stent
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`X.
`
`ii
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`

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`2.
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`2.
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`Through the Side Opening and Through the Tubular Structure
` ................................................................................................... 93
`The Evidence Does Not Show a POSITA Would Use Itou As a
`Guide Extension Catheter ......................................................... 99
`i.
`Itou and Ressemann Are Designed for Different
`Purposes, and a POSITA Would Not Reply on
`Ressemann to Modify Itou’s Use ................................. 101
`Bagaoism, Limbruno, and Baim are Also Structurally
`Different from Itou’s Suction Catheter ......................... 105
`The Evidence Does Not Show That a POSITA Would Have Modified
`Itou to Advance a Stent or Balloon Catheter Through a Side Opening
`Having At Least Two Inclined Slopes (Grounds 2-3 (Claim 45)) ... 108
`1.
`The Evidence Does Not Show that a POSITA Would Modify
`Itou in View of Ressemann to Advance a Balloon Catheter or
`Stent Through a Side Opening Structure Having At Least Two
`Inclined Slopes (Ground 2, Claim 45) ................................... 108
`i.
`Ressemann Does Not Disclose Advancing a Stent or
`Balloon Catheter Through a Side Opening Having At
`Least Two Inclined Slopes ........................................... 109
`The “Motivations” Petitioner’s Experts Identify Would
`Not Motivate a POSITA to Modify Itou’s Proximal
`Opening with Ressemann’s Support Collar in the Precise
`Way Asserted by Dr. Brecker and Dr. Hillstead .......... 117
`iii. Even if a POSITA Was Motivated to Combine Itou and
`Ressemann, the Resulting Combination Would Not Work
`and/or Would Not Satisfy the Claim Language ........... 125
`The Evidence Does Not Show that a POSITA Would Modify
`Itou in View of Kataishi to Advance a Balloon Catheter or Stent
`Through a Side Opening Structure Having At Least Two
`Inclined Slopes (Ground 3, Claim 45) ................................... 130
`The Evidence Does Not Show a POSITA Would Be Motivated to
`Increase the Length of the Tubular Portion of Itou’s Suction Catheter
`(Ground 2, Claim 47) ....................................................................... 134
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`ii.
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`ii.
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`iii
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`B.
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`C.
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`

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`2.
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`3.
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`2.
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`3.
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`B.
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`XI. KONTOS-BASED CHALLENGES (IPR2020-01344 (ALL GROUNDS))
` ..................................................................................................................... 135
`A.
`The Evidence Does Not Show a POSITA Would Modify Kontos to
`Create a Side Opening (Ground 2, Independent Claim 25) ............. 135
`1.
`The Evidence Does Not Show a POSITA Would Remove
`Kontos’ Funnel ..................................................................... 135
`The Evidence Does Not Support Dr. Brecker and Dr.
`Hillstead’s Proffered Motivations ........................................ 144
`The Evidence Does Not Show a POSITA Would Modify
`Kontos’ Tubular Structure to Have an Inner Diameter that Is
`Not More than One French Size Smaller than the Inner
`Diameter of the Guide Catheter Lumen ............................... 157
`The Evidence Does Not Show the Proposed Modifications Would
`Satisfy the Additional Limitations of Certain Dependent Claims
`(Ground 2, Dependent Claims 32, 37, and 45) ................................ 163
`1.
`The Evidence Does Not Show that Dr. Hillstead and Dr.
`Brecker’s Proposed Modifications Would Satisfy the Claimed
`“Coaxially Aligning” Step (Dependent Claim 32) ................ 163
`The Evidence Does Not Show that a Delivery System Including
`a Stent Can Be Advanced Through Kontos’ Support Catheter
`(Dependent Claims 37) .......................................................... 165
`The Evidence Does Not Show that a POSITA Would Modify
`Kontos’ Support Catheter to Create a “side opening structure
`having at least two inclined slopes” (Dependent Claim 45) .. 166
`i.
`The Evidence Does Not Show that a POSITA Would
`Focus on the Specific Shape of Ressemann’s Support
`Collar ............................................................................ 167
`The Evidence Does Not Support Dr. Brecker and Dr.
`Hillstead’s Proffered Motivations ................................ 173
`iii. The Evidence Does Not Show that Dr. Hillstead’s
`Proposed Combination Would Be Expected to Work or
`Would Result in a Side Opening with at Least Two
`Inclined Regions ........................................................... 178
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`ii.
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`iv
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`C.
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`D.
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`B.
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`B.
`C.
`D.
`E.
`F.
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`The Evidence Does Not Show a POSITA Would Modify Kontos to
`Create a Side Opening (Ground I, Claims 52 and 53) ..................... 182
`The Evidence Does Not Show a POSITA Considering Kataishi Would
`Modify Kontos to Create a Side Opening Having at Least Two
`Inclined Slopes (Ground III, Claim 45) ........................................... 182
`XII. PRIORITY DATE AND WRITTEN DESCRIPTION (IPR2020-01344
`(GROUNDS IV-V)) .................................................................................... 189
`A.
`The ’629 Application Discloses a Device Having Both a “segment
`defining a side opening” and a “substantially rigid segment” as
`Claimed ............................................................................................. 189
`The ‘629 Application Discloses a Side Opening Having “at least two
`inclined slopes” as Claimed .............................................................. 194
`XIII. OBJECTIVE INDICIA OF NONOBVIOUSNESS .................................... 194
`A.
`Interventional Cardiologists’ Use of the GuideLiner Embodies At
`Least the Method of Claim 25 of the ‘116 Patent ............................. 196
`Long-Felt Need .................................................................................. 196
`Commercial Success.......................................................................... 202
`Industry Praise ................................................................................... 204
`Licensing ........................................................................................... 207
`The Guidezilla (Boston Scientific), Boosting Catheter (QXMédical)
`and Telescope (Medtronic) Products Are All Substantially Similar to
`Teleflex’s Patented GuideLiner ........................................................ 207
`1.
`Boston Scientific Corp.’s Guidezilla Catheter Is Substantially
`Similar to the GuideLiner VI .................................................. 208
`QXMédical’s Boosting Catheter Is Substantially Similar to
`GuideLiner V1 ........................................................................ 213
`3. Medtronic’s Telescope Product Is Substantially Similar to
`GuideLiner V3 ........................................................................ 218
`G. Nexus ................................................................................................. 225
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`2.
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`v
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`I, Peter Keith, hereby declare and state as follows:
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`I have been retained by the owner of U.S. Patent No. RE46,116 (“the
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`’116 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 two petitions for inter
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`partes review (“IPR”) have been filed against certain claims of the ’116 patent.
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`The following provides my opinions in this matter.
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`I.
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`PERSONAL BACKGROUND
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`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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`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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`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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`I have been informed that the patent at issue in this set of inter partes
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`review trials is one of a family of seven patents that the Petitioner has challenged:
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`U.S. Patent Nos. 8,048,032; RE45,380; RE45,760; RE45,776; RE47,379;
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`8,142,413; and RE46,116. I refer to these as the “GuideLiner patents.”
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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 six of the seven GuideLiner patents at issue in
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`these IPRs: U.S. Patent Nos. 8,048,032; RE45,380; RE45,760; RE45,776;
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`RE46,116; and 8,142,413. U.S. Patent No. RE47,379 had not yet issued when the
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`QXM case was filed, but it is in the same family as the other six patents listed
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`above that were asserted in the QXM case.
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`I have also provided expert opinions concerning five of the
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`GuideLiner patents on behalf of Teleflex in the case of Vascular Solutions LLC, et
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`3
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`al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.). Those opinions were
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`provided in connection with Teleflex’s Motion for Preliminary Injunction. I have
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`also provided expert opinions in IPR2020-00126, -00127, -00128, -00129, -00130,
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`-00132, -00134, -00135, -00137, and -00138, in which U.S. Patent Nos. 8,048,032;
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`RE45,380; RE45,760; RE45,776, and RE47,379 were at issue.
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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
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`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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`I have also reviewed the patent at issue in the above-referenced inter
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`partes review proceedings and its file history, as well as the other six GuideLiner
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`patents and their file histories.
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`4
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`I have reviewed the Petitions filed in each of the IPR2020-01341,
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`01342, 01343, and 01344 proceedings. I have also reviewed the Institution
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`Decisions issued by the Patent Trial and Appeal Board in each of the IPR2020-
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`01341, 01342, 01343, and 01344 matters.
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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 IPR2020-01341, 01342, 01343,
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`and 01344 proceedings. Dr. Brecker’s declarations were labeled with an exhibit
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`number having the form “Ex-1_05”, and Dr. Hillstead’s declarations were labeled
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`with an exhibit number having the form “Ex-1_42.” 1
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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 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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`1 Unless otherwise noted, all exhibit cites are to the exhibits in IPR2020-01343.
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`5
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`III. LEGAL STANDARDS
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`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
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`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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` Obviousness
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`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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`
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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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`6
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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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`IV. SCOPE OF OPINIONS
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`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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`7
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
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`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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`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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`8
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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 claimed methods by at least by August, 2005.
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`Given my experience described in this declaration and in my CV, I also am very
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`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 ’116 PATENT
` Background on the Technology: Coronary Catheters and Heart
`Disease
` The technology involved in this case pertains to coronary catheter
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`procedures. These are procedures for treating conditions in the blood vessels of
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`the heart itself (coronary arteries). More specifically, this case pertains to a
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`method of using a specialized catheter device called a “guide extension catheter.”
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`As a result of my extensive experience in the medical device field, and in particular
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`with catheter technology, I have become very familiar with coronary catheter
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`9
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`procedures and the devices used for those procedures. The following paragraphs
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`provide an overview of heart disease, coronary catheters, and coronary catheter
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`procedures that is based on this 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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`
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`10
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`

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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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`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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`11
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`

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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
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`below). It is therefore critical that these catheter devices are able to be positioned
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`within the blockage, and positioned quickly, to treat the patient successfully.
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`
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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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`12
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`

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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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`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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`
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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
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`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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`13
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`

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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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`typically used as the access vessel to gain access to the aorta and the coronary
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`arteries as will be described below. (See diagram below—B.)
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`
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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
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`the technology in the case at issue.
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` 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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`14
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`

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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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`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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` 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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` 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, 3:39-55. This is not unusual or surprising
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`because, as I noted above, guide catheters were typically sized according to their
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`outer diameter, whereas the inner diameter varies depending not just on outer
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`diameter, but also on wall thickness. Therefore, a POSITA would interpret a “one
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`French size” difference consistently with the specification, rather than in
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`accordance with the strict mathematical definition of “French.” Thus, for example,
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`when a guide extension catheter having an internal diameter of at least 0.056
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`inches is used with a 6 French guide catheter (which would typically have an
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`external diameter of ~0.079 inches and an internal diameter of ~ 0.070-0.071
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`inches), the guide extension catheter is used with a guide catheter that is one
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`French size different.
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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 ap