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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`Declaration of Dr. John J. Graham, MB ChB, MRCP (UK)
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
`A. Qualifications ........................................................................................ 2
`B. Materials Considered ............................................................................. 4
`LEGAL STANDARDS .................................................................................. 5
`A. Claim Construction ............................................................................... 6
`B. Anticipation ........................................................................................... 7
`C. Obviousness ........................................................................................... 8
`III. SCOPE OF OPINIONS ................................................................................... 9
`IV. PERSON OF ORDINARY SKILL IN THE ART ........................................ 11
`V. BACKGROUND ON THE USE OF GUIDE EXTENSION CATHETERS
`IN PCI ............................................................................................................ 13
`A. Complex PCI ....................................................................................... 18
`B. Various Methods for Solving the Backup Support Problem in the
`1990s and 2000s Were Unsuccessful .................................................. 23
`VI. THE GUIDELINER DEVICE ....................................................................... 33
`A. Use of the GuideLiner ......................................................................... 36
`B.
`Benefits of the GuideLiner Inventions ................................................ 40
`1.
`Enhanced backup support ......................................................... 40
`2.
`Ability to safely deep seat ......................................................... 42
`3.
`Rapid exchange functionality ................................................... 43
`4.
`Advancing the full array of interventional cardiology devices
`into the guide extension catheter while the guide extension
`catheter was inside the guide catheter ....................................... 44
`VII. THE MEANING OF CERTAIN TERMS USED IN THE CLAIMS OF THE
`‘413 PATENT ................................................................................................ 46
`A.
`“Interventional Cardiology Device” .................................................. 46
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`B.
`
`B.
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`C.
`
`The Claimed Method Steps Require that an Interventional Cardiology
`Device Must be Inserted into the Standard Guide Catheter After the
`Coaxial Guide Catheter ....................................................................... 50
`VIII. THE STATE OF THE ART AT THE TIME OF INVENTION OF THE
`GUIDELINER PATENTS ............................................................................ 53
`A.
`The General Knowledge of an Interventional Cardiologist at the Time
`of the Invention ................................................................................... 53
`Itou (Ex. 1007) ................................................................................... 56
`1.
`The “protective catheter 5” disclosed in Itou is not an
`“interventional cardiology device” as defined by the
`GuideLiner patents .................................................................... 59
`Itou does not disclose a configuration capable of receiving
`stents/stent catheters .................................................................. 62
`Inserting an interventional cardiology device into Itou’s suction
`catheter after suction without first flushing the suction catheter
`outside the body would be dangerous ....................................... 63
`Ressemann (Ex. 1008) ........................................................................ 65
`1.
`Ressemann teaches a non-coaxial evacuation lumen ............... 67
`2.
`Ressemann does not disclose a proximal side opening with two
`inclines ...................................................................................... 70
`D. Kontos (Ex. 1009) .............................................................................. 75
`1.
`A POSITA would not expect Kontos to provide more than
`trivial backup support ............................................................... 76
`Kontos discloses a funnel structure to account for the proximal
`gap created by the configuration of its body 12 and to avoid
`problems with device hang-up on its proximal opening ........... 77
`A POSITA would not extend Kontos’ body entirely out the
`distal end of the guide catheter ................................................. 77
`4.
`Kontos’ lumen would not accept stents or stent catheters ........ 78
`E. Kataishi (Ex. 1025) ............................................................................ 79
`F.
`Adams (Ex. 1035) ............................................................................... 81
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`2.
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`3.
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`2.
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`3.
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`2.
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`2.
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`G.
`Takahashi (Ex. 1010) ......................................................................... 85
`IX. AN INTERVENTIONAL CARDIOLOGIST PRACTICING AT THE TIME
`OF THE INVENTION WOULD NOT BE MOTIVATED TO COMBINE
`THE INVETIONS DISCLOSED IN THE PRIOR ART .............................. 86
`A.
`Itou + Ressemann and Knowledge of a POSITA ............................... 86
`1.
`An interventional cardiologist at the time of the invention
`would not look to Ressemann to modify Itou ........................... 86
`An interventional cardiologist practicing at the time of the
`invention would not modify Itou’s proximal opening with
`Ressemann’s support collar 2141 ............................................. 90
`B. Kontos + Adams and Knowledge of a POSITA ................................. 95
`C. Kontos + Ressemann and Knowledge of a POSITA ........................ 103
`1.
`An interventional cardiologist at the time of the invention
`would not replace Kontos’ funnel with Ressemann’s angled
`opening .................................................................................... 103
`An interventional cardiologist practicing at the time of the
`invention would not modify Kontos’ funnel with Ressemann’s
`support collar 2141 ................................................................. 106
`D. Kontos in View of Takahashi and Knowledge of a POSITA
`Combinations ..................................................................................... 108
`Combinations Using Kataishi (Ex. 1025) and Knowledge of a
`POSITA ............................................................................................. 109
`X. OPINIONS ON OBJECTIVE EVIDENCE OF NON-OBVIOUSNESS ... 112
`A. Nexus and Clinical Success ............................................................... 112
`B.
`Long-Felt Need .................................................................................. 114
`C.
`Industry Praise ................................................................................... 116
`D. At Least Two Competitors Have Launched Products that Are
`Substantially Similar to GuideLiner .................................................. 121
`1. Medtronic’s Telescope Guide Extension Catheter ................. 121
`2.
`Boston Scientific’s Guidezilla Guide Extension Catheter ...... 124
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`E.
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`I, John J. Graham, hereby declare and state as follows:
`INTRODUCTION
`I.
` My name is Dr. John J. Graham, MB ChB, MRCP (UK). I make this
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`declaration based on my own knowledge. I am an interventional cardiologist at St.
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`Michael’s Hospital in Toronto, Canada. I am also an Assistant Professor, Division
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`of Cardiology, at the University of Toronto. I have over 20 years of experience in
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`interventional cardiology. I have performed thousands of percutaneous coronary
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`intervention (PCI) procedures, including many hundreds of complex procedures
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`using a guide extension catheter.
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`
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`I have been retained by the Patent Owner Teleflex as an independent
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`expert to provide my opinions as a practicing interventional cardiologist on certain
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`issues. I have been asked to provide my independent expert opinions and
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`testimony in connection with the Inter Partes Review proceedings initiated by
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`Medtronic, Inc. and Medtronic Vascular, Inc. (“Medtronic” or “Petitioner”) against
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`Teleflex concerning U.S. Patents 8,142,413 (“the ’413 patent”), and RE46,116
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`(“the ’116 patent”). I understand these proceedings have the case numbers
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`IPR2020-01341, IPR2020-01342, IPR2020-01343, and IPR2020-01344. I have
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`also previously provided opinions in connection with the prior eleven IPR
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`proceedings, which I understand have the case numbers IPR2020-00126, IPR2020-
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`00127, IPR2020-00128, IPR2020-00129, IPR2020-00130, IPR2020-00132,
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`IPR2020-00134, IPR2020-00135, IPR2020-00136, IPR2020-00137, and IPR2020-
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`00138. For my time, I am being compensated at $500 per hour, my standard rate
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`for this type of consulting. My compensation is not contingent on the result of this
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`or any other legal proceeding.
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`A. Qualifications
`The following paragraphs summarize my educational background and
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`career history. My full curriculum vitae, summarizing my credentials in more
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`detail, is attached as Appendix A to this declaration.
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`
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`I received a Bachelor of Science degree with First Class Honours in
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`Neuroscience from the University of Glasgow, United Kingdom in 1992. I then
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`received a Bachelor of Medicine, Bachelor of Surgery degree with Commendation
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`from the University of Glasgow in 1995.
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`
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`After medical school, I completed senior house officer posts at
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`Glasgow Royal Infirmary and the Royal Brompton Hospital.
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`
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`I then undertook specialist registrar training in cardiology under the
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`auspices of the University of London deanery, based between St. Bartholomew’s
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`and the London Chest Hospital. During my specialist cardiology training I
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`undertook a combined research/interventional cardiology fellowship at the
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`University of Toronto, based at Sunnybrook Health Sciences Centre. By 2005, I
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`had performed approximately 1,000 angioplasties.
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`In 2008, I received my Specialist Certification in Cardiology and
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`began working as a Staff Interventional Cardiologist at St. Michael’s Hospital in
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`Toronto, Ontario, Canada. I also assumed a role as an Assistant Professor in the
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`Department of Medicine, Division of Cardiology, at the University of Toronto.
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`
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`In 2009, I was appointed Visiting Scientist in the Cardiac Programme,
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`Imaging Research, Faculty of Medicine at the University of Toronto, Sunnybrook
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`Health Sciences Centre. Throughout my career, I have remained committed to
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`research in the cardiology field, and I have authored over 40 articles published in
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`peer-reviewed journals and several book chapters.
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`
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`In addition to the above, I am the Interventional Cardiology
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`Fellowship Director at St. Michael’s Hospital and the course director for the
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`University of Toronto Interventional Cardiology Fellowship lecture series. I am
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`the medical lead for complex angioplasty at St. Michael’s Hospital and the
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`Director of the CTO/CHIP (Chronic Total Occlusion/Complex High risk and
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`Indicated PCI) program. Within this, every two years, I am responsible for
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`training 6–8 fellows in all aspects of coronary intervention and lecture widely on
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`complex coronary intervention.
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` Over the course of my career, I have performed several thousand PCI
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`procedures, including over 1,000 complex PCI procedures. Between 2000 and
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`2005, I performed approximately 1,000 PCI procedures. From 2006-2008, I
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`performed approximately 1,000 more PCI procedures. Since 2008, I’ve performed
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`300-400 PCIs per annum, including 100-140 CTO (complex) PCIs, and I continue
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`to do so today. I regularly proctor physicians in the use of rotational atherectomy
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`and CTO PCI and co-chair the quarterly Greater Toronto Area CTO PCI Rounds.
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`
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`I have used Teleflex’s GuideLiner product many hundreds of times
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`since its introduction in 2009, and I continue to use GuideLiner today. I have used
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`each version of the GuideLiner product—the GuideLiner V1, the GuideLiner V2,
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`and the GuideLiner V3. I have also used and am familiar with the Boston
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`Scientific Guidezilla guide extension catheter and the Medtronic Telescope guide
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`extension catheter. On average, I use a guide extension catheter approximately 10-
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`15 times per month.
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`B. Materials Considered
` In preparing this declaration, I relied on my years of experience and
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`expertise in the interventional cardiology field, including my experiences with
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`GuideLiner and other guide extension catheters. I have also reviewed the
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`declarations of Medtronic’s expert Dr. Brecker that accompanied the Petitions filed
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`in IPR2020-01341, 01342, 01343, and 01344. I have also reviewed many of the
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`exhibits filed with those petitions, including (but not limited to) the references I
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`specifically discuss in this declaration.1 I have also reviewed the two patents
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`challenged in these proceedings.
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`II. LEGAL STANDARDS
` I am not an attorney and I have not independently researched the law on
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`patentability. I have been informed by counsel of the legal standards set forth
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`below.
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`1 I cite the references I discuss in this declaration according to the way they are
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`numbered in IPR2020-01341 (e.g. Ex. 1007.). However, I understand that the
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`same set of exhibits was filed in each of the four IPRs concerning the two
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`GuideLiner patents, always retaining the same final two numbers. There are
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`several exceptions to this general rule, including at least the exhibits ending in
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`“01,” “05,” and “42;” slightly different versions of these documents were filed in
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`each of the IPRs, although there is much duplication of content. When I cite these,
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`I indicate the respective IPR number. I note that the specification of the patents at
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`issue in these proceedings is identical, and so to the extent I cite to the
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`specification of the ʼ413 patent (IPR2020-01341, Ex. 1001) that teaching is also
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`present in the ʼ116 patent (IPR2020-01343, Ex. 1001).
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`5
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`A. Claim Construction
` I understand that in patent law there is a concept called claim
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`construction. I understand this to mean the process of determining what meaning a
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`claim term should have.
`
` 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 patentee may be his/her own lexicographer, so long
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`as the definition of a specific term is clearly set forth in the specification and it is
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`clear the inventor intended to define the term.
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` I understand that the parties agreed to constructions for certain claim
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`terms in a previous case in U.S. federal court, called the “QXM” case. I
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`understand that those constructions are provided in the document filed by the
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`Petitioner as Exhibit 1012. Other than as specifically discussed in this declaration,
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`I do not at this time offer any opinions regarding those constructions. Rather, I
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`apply the constructions the parties agreed upon for the purpose of this declaration.
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` For any claim terms for which I do not specifically offer a construction
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`and that are not among the definitions the parties agreed to in the Exhibit 1012
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`document from the QXM case, I have applied the plain and ordinary meanings as
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`would be understood by a person of ordinary skill in the art (“POSITA”) at the
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`time of invention. I explain my understanding of the phrase “POSITA” below.
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`B. Anticipation
` I understand that one of the issues in the Inter Partes Review
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`proceedings involving the GuideLiner patents is whether certain claims of those
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`patents would have been anticipated by one or more of the prior art references
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`identified by the Petitioner.
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`
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`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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`
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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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`
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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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`
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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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`C. Obviousness
` I understand that one of the issues in the Inter Partes Review
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`proceedings involving the GuideLiner patents is whether certain claims of those
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`patents would have been obvious to a POSITA at the time of invention.
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`
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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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`
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`I understand that objective, real-world evidence can show non-
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`obviousness. I also understand that it can sometimes be the most probative
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`evidence of whether an invention is obvious or not. I understand that this objective
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`evidence of non-obviousness can include a long-felt but unmet need, industry
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`praise, commercial success of a product embodying the invention, licensing of the
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`invention by other competitors, and copying.
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`
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`I also understand that objective evidence such as commercial success
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`of the patented product and industry praise of the product must have a nexus to the
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`claimed invention. I understand that a party may prove nexus by showing that the
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`objective evidence is the direct result of the unique characteristics of the claimed
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`invention and that where a patent claims a combination of features, the objective
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`evidence may be tied to the claimed combination as a whole.
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`
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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
`
`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
`
`art to which said subject matter pertains.
`
`III. 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.
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` I have been asked to provide an interventional cardiologist’s
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`perspective on the history of PCI procedures, the challenges therein, the efforts to
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`address those challenges, and the GuideLiner product’s role in and clinical utility
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`for PCI procedures.
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` I have been asked to review the two patents challenged by the Petitioner
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`in the present IPR proceedings and provide my opinions regarding the way certain
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`claim terms are used in those patents: U.S. Pat. Nos. 8,142,413 and RE46,116. I
`
`refer to these patents as the “GuideLiner patents.” I understand that the
`
`specification of both of these patents is materially the same. I also understand that
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`each of these patents has been filed as “Exhibit 1001” (or some variation of that
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`number, but always ending in “01”) in the particular IPR proceeding(s) that
`
`challenges that patent. I have also reviewed the five patents challenged by the
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`Petitioner in its earlier-filed IPR proceedings: U.S. Patent No. 8,048,032; U.S.
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`Patent No. RE45,380; U.S. Patent No. RE45,760; U.S. Patent No. RE45,776; and
`
`U.S. Patent No. RE47,379.
`
` I have also been asked to provide my opinions regarding the disclosures
`
`in the following references, from the perspective of an interventional cardiologist
`
`at the time of invention:
`
`• U.S. Patent No. 7,736,355 (Ex. 1007, “Itou”)
`
`• U.S. Patent No. 7,604,612 (Ex. 1008, “Ressemann”)
`
`• U.S. Patent No. 5,439,445 (Ex. 1009, “Kontos”)
`
`• U.S. Publication Application No. 2004/0010280 (Ex. 1035, “Adams”)
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`• U.S. Publication Application No. 2005/0015073 (Ex. 1025, “Kataishi”)
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`• New Method to Increase a Backup Support of a 6 French Guiding Coronary
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`Catheter, Catheterization and Cardiovascular Interventions, 63:452-456
`
`(2004) (Ex. 1010, “Takahashi”)
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` I have also been asked to provide my opinions regarding specific uses,
`
`combinations, and/or modifications of the above-identified references that Dr.
`
`Brecker and Dr. Hillstead propose, from the perspective of an interventional
`
`cardiologist at the time of invention.
`
` Finally, I have also been asked to offer my opinions on the
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`GuideLiner product’s commercial and clinical success, industry praise for
`
`GuideLiner, whether GuideLiner solved a long-felt need in the interventional
`
`cardiology field, and whether competing products I have used (Medtronic’s
`
`Telescope and Boston Scientific’s Guidezilla) are substantially similar to the
`
`GuideLiner. I understand that my opinions may be relevant to whether Teleflex’s
`
`patents are valid, in that commercial success, industry praise, long-felt need, and
`
`copying tend to show that an invention was not obvious, but I have not been asked
`
`to render an opinion on obviousness apart from these considerations, and my
`
`analysis is confined to these subjects.
`
`IV. PERSON OF ORDINARY SKILL IN THE ART
`I understand that in United States patent law, there is a concept called
`
`
`the “person of ordinary skill in the art” or “POSITA”. I understand that this is the
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`perspective from which prior art, questions of anticipation, motivation to combine,
`
`reasonable expectations of success, and other factual questions must be evaluated.
`
`
`
`I understand that the Petitioner and Dr. Brecker have proposed a
`
`definition of a POSITA: “a person of ordinary skill in the art (“POSITA”) at the
`
`time of the alleged invention would have had (a) a medical degree, (b) completed a
`
`coronary intervention training program, and (c) experience working as an
`
`interventional cardiologist. Alternatively, a POSITA would have had (a) an
`
`undergraduate degree in engineering, such as mechanical or biomedical
`
`engineering; and (b) three years of experience designing medical devices,
`
`including catheters or catheter-deployable devices. [. . .] Extensive experience and
`
`technical training might substitute for education, and advanced degrees might
`
`substitute for experience. Additionally, a POSITA with a medical degree may have
`
`access to a POSITA with an engineering degree, and one with an engineering
`
`degree might have access to one with a medical degree.” E.g., IPR2020-01341,
`
`Ex. 1005, at ¶ 31. I do not provide any opinions regarding this definition, but I do
`
`apply it when providing my opinions below.
`
` I have a medical degree, I have completed a coronary intervention
`
`training program, and I have experience working as an interventional cardiologist.
`
`Therefore, I am a person of ordinary skill in the art, under the definition provided
`
`by the Petitioner and Dr. Brecker.
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`12
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`
`
`I understand that when offering my opinions in this declaration
`
`regarding (i) what the specific references Dr. Brecker and Dr. Hillstead rely on
`
`disclose and teach a POSITA and (ii) regarding the specific combinations and
`
`modifications of those references that Dr. Brecker and Dr. Hillstead propose, I am
`
`to provide my analysis from the perspective of a POSITA at the time of invention.
`
`I understand that this date is no later than May 3, 2006, the date on which the
`
`earliest patent application for the family of GuideLiner patents was filed.
`
`Therefore when I provide my opinions, I note that they are from the perspective of
`
`a POSITA in May 2006. However, I have been told that the inventors actually
`
`invented claims of the GuideLiner patents by at least August, 2005. I also am
`
`familiar with the level of skill and knowledge a POSITA would have had in the
`
`year 2005. I note that my opinions would not change, whether the relevant date of
`
`invention is early-to-mid-2005 or May 2006.
`
`V. BACKGROUND ON THE USE OF GUIDE EXTENSION
`CATHETERS IN PCI
`I have reviewed the declaration of Medtronic’s cardiologist, Dr.
`
`
`Brecker, and I generally agree with portions of his description of interventional
`
`cardiology, including the use of catheterization procedures to treat heart disease.
`
`While I generally agree with portions of Dr. Brecker’s description, I believe it is
`
`helpful to provide more detail on the treatment of complex interventional
`
`cardiology cases to better explain the significance and success of the GuideLiner.
`13
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`

` The GuideLiner guide extension catheter is used in PCI procedures,
`
`which are nonsurgical, minimally invasive procedures in which a physician uses
`
`balloons, stents, or other devices to treat a stenosis (narrowing of a blood vessel) in
`
`the coronary arteries. PCI is an alternative to open-heart surgery. Although both
`
`techniques are effective at restoring blood flow to oxygen-starved areas of the
`
`heart, PCI is often preferred to open-heart surgery because it is less invasive, less
`
`expensive, less risky, and requires less recovery time. Patients can walk into a
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`hospital for PCI, walk out the same or next day, and return to normal work activity
`
`two to three days later. In contrast, open-heart surgery is usually followed by one
`
`to two days of intensive care, up to a week of hospitalization, and a recovery time
`
`of up to twelve weeks. In addition, PCI is performed in a cardiac catheterization
`
`laboratory under a mild sedative, rather than in an operating room under general
`
`anesthesia.
`
` PCI often involves the use of a balloon catheter, which is advanced
`
`through the vasculature and into the lesion where it is expanded one or more times
`
`to compact the plaque or thrombus against the arterial wall. This effectively
`
`widens the lumen and improves blood flow. This process is known as balloon
`
`angioplasty. Balloon angioplasty, when performed, is nearly always followed by
`
`stent placement. Stent delivery catheters generally have a stent in a compact
`
`configuration mounted over a dilation balloon. When the stent is positioned
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`14
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`through the lesion, the dilation balloon is inflated, which expands the stent to
`
`create a metal scaffold that dilates the lesion and maintains the expanded diameter
`
`of the blood vessel.
`
` Stent and balloon catheters often feature a “monorail” or “rapid
`
`exchange” design, which has existed since at least the late 1980s. The Bonzel
`
`reference (published 1987) shows one of the first, if not the first, monorail balloon
`
`catheters. Ex. 1032. The Enger reference (filed in 1989) is another example of a
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`“monorail” or “rapid exchange” type balloon catheter. Ex. 1050. A rapid
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`exchange or monorail design refers to a device (usually a stent or balloon catheter)
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`that has a relatively short distal lumen portion that rides over the guidewire, as
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`opposed to the full-length lumen of a catheter being advanced over the guidewire.
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`Such rapid exchange catheters featured a small lumen that served as a “track” for
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`the guidewire to run through. An image of the Bonzel monorail catheter is below,
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`and the guidewire (f) and guidewire lumen (h) visible:
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`Ex. 1032, at 9.
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` Because the distal tip of a guidewire was known to be delicate, and
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`was usually advanced into the vasculature before the stent or balloon catheter, the
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`proximal end of the guidewire was typically fed into the distal end of the guidewire
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`lumen of the rapid exchange stent or balloon catheter. This was known as “back-
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`loading.” It was also possible to “front-load” a rapid exchange stent or balloon
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`catheter—i.e., insert the distal tip of the guidewire into the proximal opening of the
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`guidewire lumen—but this was rarely done.
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` The process of loading a rapid-exchange or monorail stent or balloon
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`catheter onto a guidewire (whether back-loaded or front-loaded) was always done
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`outside the body, before the stent or balloon catheter was inserted into the guide
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`catheter. A POSITA would have considered it nearly impossible to somehow
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`thread the guidewire into the guidewire lumen of a rapid exchange catheter (like
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`the one shown in Enger or Bonzel) if the guidewire lumen opening was already
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`inside the guide catheter, where the cardiologist could not manipulate the
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`guidewire vis-à-vis the guidewire lumen opening under direct observation. In fact,
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`if for some reason a guidewire came out of the monorail/rapid exchange lumen
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`while the monorail/rapid exchange catheter was inside a guide catheter, a POSITA
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`would have thought it impossible to try to thread the guidewire back into that
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`monorail lumen while the guidewire and the monorail catheters remained inside
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`the guide catheter. The only option would have been to completely withdraw the
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`stent or balloon catheter entirely out of the guide catheter, while attempting to
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`leave the guidewire in its location beyond the stenosis, and then try to re-thread the
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`proximal end of the guidewire into the (distal) end of the monorail lumen outside
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`of the guide catheter and outside the body, and then reintroduce the stent or balloon
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`catheter (on the guidewire) back into the body.
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` Rapid exchange or monorail stent and balloon catheter devices
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`differed from what were known as “over the wire” and “fixed wire” devices. Fixed
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`wire interventional devices have a wire core incorporated into the catheter
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`extending out of the end of the catheter. This wire is used to assist steering of the
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`device. Consequently, a separate guidewire (and guidewire lumen on the balloon
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`catheter) was not required and such devices had only a single, balloon inflation,
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`lumen. Fixed wire was the design employed in the first human coronary balloon
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`angioplasty, described in 1977. However, steering of these devices was difficult
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`and fixed wire devices are rarely used now. Over the wire (OTW) balloon devices
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`were developed to overcome the steering issues with fixed wire devices. OTW
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`balloon catheters have a guidewire lumen extending from the distal tip all the way
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`to the proximal hub. This guidewire lumen meant that OTW balloon devices had 2
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`lumens: one for the guidewire and one for contrast to inflate the balloon. By
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`design, OTW balloon catheters required a long (usually 300 cms) guidewire to
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`ensure that the wire position could be fixed (and the wire could not migrate in the
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`body) while this OTW balloon catheter was inserted or removed.
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`A. Complex PCI
` Within the field of PCI, there is a spectrum of case complexity. Some
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`features of complexity relate to the patient’s overall condition (age, kidney
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`function, comorbid conditions, etc.), however, a large determinant of case
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`complexity relates to characteristics of the atheromatous lesion(s) itself. In 1993,
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`in an attempt to allow descriptive quantification of this varied complexity, the
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`American Heart Association and American College of Cardiology
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`(“AHA”/“ACC”) issued a joint paper which introduced the ‘ABC’ system of lesion
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`morphology. Ex. 2150, at 8. Briefly, ‘A’ type lesions are the most straightforward
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`and ‘C’ type lesions have the most complicated features. Id.
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` The GuideLiner and other guide extension catheters are primarily
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`used in PCI cases classified by interventional cardiologists