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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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`IPR2020-01341
`IPR2020-01342
`Patent 8,142,413
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`DECLARATION OF PETER T. KEITH
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`TABLE OF CONTENTS
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`PERSONAL BACKGROUND ....................................................................... 1
`I.
`II. MATERIALS CONSIDERED ........................................................................ 4
`III. LEGAL STANDARDS ................................................................................... 6
`A. Claim Construction................................................................................ 6
`B. Anticipation ........................................................................................... 6
`C. Obviousness ........................................................................................... 7
`IV. SCOPE OF OPINIONS ................................................................................... 8
`V. PERSON OF ORDINARY SKILL IN THE ART .......................................... 8
`VI. OVERVIEW OF THE TECHNOLOGY OF THE ’413 PATENT ...............10
`A. Background on the Technology: Coronary Catheters and Heart
`Disease .................................................................................................10
`B. Background on the Technology: Teleflex’s GuideLiner Devices ......37
`C. The GuideLiner In Use ........................................................................50
`VII. THE ’413 PATENT .......................................................................................51
`VIII. CLAIM CONSTRUCTION ..........................................................................58
`A. The Final Step of Claim 1 (“Inserting the Interventional Cardiology
`Device…) Must Be Performed After the Other Claimed Steps ..........59
`“Interventional Cardiology Device” ...................................................63
`B.
`IX. THE REFERENCES PETITIONER’S EXPERTS RELY ON .....................67
`A.
`Itou (Ex-1007) .....................................................................................67
`B. Ressemann (Ex-1008) .........................................................................70
`C. Kontos (Ex-1009) ................................................................................72
`
`i
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`X.
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`3.
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`4.
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`2.
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`D. Adams (Ex-1035) ................................................................................86
`E. Takahashi (Ex-1010) ...........................................................................89
`ITOU-BASED CHALLENGES ....................................................................91
`A. The Evidence Does Not Show That Itou Anticipates the Challenged
`Claims (IPR2020-01341 Ground 1, Claims 1-2, 4, 7-14) ...................91
`1.
`The Evidence Does Not Show Itou’s Protective Catheter Is
`an “interventional cardiology device” (Claims 1-2, 4, 7-14) ...91
`The Evidence Does Not Show Itou’s Protective Catheter Is
`Inserted Through the Guide Catheter “alongside of the
`substantially rigid portion” (Claims 1-2, 4, 7-14) .....................94
`The Evidence Does Not Show that Itou Discloses “applying a
`force to . . . a coaxial guide catheter such that the distal portion
`of the coaxial guide catheter remains seated . . . in response to
`an opposing backward force exerted by the interventional
`cardiology device” (Claim 2) ....................................................95
`The Evidence Does Not Show that Itou Discloses “extending
`the interventional cardiology device through a proximal side
`opening . . . while the proximal portion remains within the
`lumen of the guide catheter” (Claims 9-12)..............................97
`B. The Evidence Does Not Show That A POSITA Would be Motivated
`to Insert Interventional Cardiology Devices Into Itou’s Suction
`Catheter (IPR2020-01341 Ground 2, All Challenged Claims) .........100
`1.
`The Evidence Does Not Show that a POSITA Would Be
`Motivated to Insert Interventional Cardiology Devices into
`Itou’s Proximal Opening While the Suction Catheter Is in
`the Guide Catheter (All Challenged Claims) ..........................100
`The Evidence Does Not Show a POSITA Would Be Motivated
`to Use Itou’s Suction Catheter to Provide Backup Support
`for the Delivery of Interventional Cardiology Devices
`(Claims 2 and 7) ......................................................................112
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`2.
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`ii
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`C. The Evidence Does Not Show A POSITA Would Be Motivated
`to Insert Interventional Cardiology Devices Into Itou’s Suction
`Catheter in View of Ressemann (IPR2020-01341 Ground 3, All
`Challenged Claims) ...........................................................................113
`1.
`Itou and Ressemann Are Designed for Different Purposes,
`and a POSITA Would Not Rely on Ressemann to Modify
`Itou (All Challenged Claims) ..................................................115
`2. Bagaosian, Limbruno, and Baim are Also Structurally
`Different from Itou’s Suction Catheter (All Challenged
`Claims) ....................................................................................120
`XI. KONTOS-BASED CHALLENGES ...........................................................122
`A. The Evidence Does Not Show that a POSITA Would Use Kontos
`and/or Adams in the Manner Required by the Claimed Method
`Steps (IPR2020-01342, All Grounds, All Claims) ...........................122
`B. The Evidence Does Not Show that Kontos Discloses Particular
`Claimed Methods of Providing Backup Support (IPR2020-01342,
`Ground 1, Claims 2 and 7) ................................................................125
`1. Kontos Does Not Disclose the Specific Steps of Claim 2 ......125
`2.
`The Evidence Does Not Show a POSITA Would Look to
`Kontos to Provide Backup Support As Claimed (Claims 2
`and 7) .......................................................................................126
`C. The Evidence Does Not Show a POSITA Would Modify Kontos
`in View of Adams to Create a Proximal Side Opening (IPR2020-
`01342, Ground 1, Claims 4, 9-12, and 14) ........................................130
`1. A POSITA Would Understand Removing Kontos’s Funnel
`Would Create Problems, Not Solve Them (Claims 4, 9-12,
`and 14) .....................................................................................130
`2. Adams Does Not Teach or Suggest that the Guide Seal’s
`Angled Proximal Opening Is Intended to Facilitate Introducing
`Devices into the Guide Seal Itself, and Actually Teaches
`that the Guide Seal Is Preferably Removed Before Introducing
`any Treatment Devices (Claims 4, 9-12, and 14) ...................139
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`iii
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`3.
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`The Evidence Does Not Show A POSITA Would Have
`Been Motivated to Combine Kontos and Adams (Claims
`4, 9-12, and 14) .......................................................................141
`D. The Evidence Does Not Show a POSITA Would Modify the Inner
`Diameter of the Lumen of Kontos’s Tubular Structure “to be not
`more than one French smaller than the cross-sectional inner
`diameter of the guide catheter” (IPR2020-01342, Ground 2,
`Claim 13) ...........................................................................................154
`XII. OBJECTIVE EVIDENCE OF NONOBVIOUSNESS ...............................161
`A. The Use of GuideLiner Embodies At Least the Methods of
`Claims 4, 9, and 14 of the ’413 Patent ..............................................162
`B. Long-Felt Need ..................................................................................163
`C. Commercial Success..........................................................................168
`D.
`Industry Praise ...................................................................................170
`E. Licensing ...........................................................................................173
`F.
`The Guidezilla (Boston Scientific), Boosting Catheter (QXMédical)
`and Telescope (Medtronic) Products Are All Substantially Similar
`to Teleflex’s Patented GuideLiner ....................................................174
`1. Boston Scientific Corp.’s Guidezilla Catheter Is
`Substantially Similar to the GuideLiner V1 ...........................174
`2. QXMédical’s Boosting Catheter Is Substantially Similar
`to GuideLiner V1 ....................................................................180
`3. Medtronic’s Telescope Product Is Substantially Similar
`to GuideLiner V3 ....................................................................184
`G. Nexus ......................................................................................................192
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`iv
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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. 8,142,413 (“the
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`’413 patent”), whom I will refer to in this declaration as “Teleflex,” to provide my
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`independent expert opinions in this matter. I understand that a petition for inter
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`partes review (“IPR”) has been filed against certain claims of the ’413 patent.
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`The following provides my opinions in this matter.
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`I.
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`PERSONAL BACKGROUND
`I summarize my educational background and career history in the
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`following paragraphs. My complete qualifications are provided in my curriculum
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`vitae, which is attached to this declaration as Appendix A.
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`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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`Since 1997, I have served as an independent consultant for early
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`stage medical device companies in the areas of product design and intellectual
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`property development. Many of my consulting clients and/or the products they
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`developed with my assistance were subsequently acquired by large medical
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`technology companies, including St. Jude Medical/Abbott, Johnson & Johnson,
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`Teleflex, Edwards Lifesciences and LivaNova. A number of the products I have
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`consulted on have been in the field of interventional cardiology, particularly
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`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
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`interventional cardiology. I have also done considerable work outside the area of
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`interventional cardiology, including in treatments for orthopedics for extremities
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`such as feet and ankles and treatment of spinal disorders. In 2006, I co-founded
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`Entellus Medical, a company focused on catheter-based treatments for chronic
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`sinusitis. As Chief Technology Officer, I led the product development and
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`research teams. Entellus successfully commercialized a series of ground-breaking
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`products developed under my leadership. Entellus went public in 2015, and was
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`acquired by Stryker in 2018 for over $600 million.
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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
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`U.S. patents, as well as many corresponding patents in foreign countries.
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`Numerous patent applications on which I am a named inventor are still pending.
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`Many of these patents concern catheters.
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`I have been informed that the patent at issue in this inter partes
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`review trial 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
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`technology at issue and the GuideLiner patents. Among other things, I provided
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`expert analysis on behalf of Teleflex in the case of QXMédical, LLC v. Vascular
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`Solutions LLC, et al., No. 0:17-cv-01969 (D. Minn.) (the QXM case). In the
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`QXM case, among the patents asserted were six of the seven GuideLiner patents
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`at issue in these IPRs: U.S. Patent Nos. 8,048,032; RE45,380; RE45,760;
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`RE45,776; RE46,116; and 8,142,413. U.S. Patent No. RE47,379 had not yet
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`issued when the QXM case was filed, but it is in the same family as the other six
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`patents listed above that were asserted in the QXM case.
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`I have also provided expert opinions concerning five GuideLiner
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`patents at issue in these proceedings on behalf of Teleflex in the case of Vascular
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`3
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`Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.).
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`Those opinions were provided in connection with Teleflex’s Motion for
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`Preliminary Injunction. I have also provided expert opinions in IPR2020-00126, -
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`00127, -00128, -00129, -00130, -00132, -00134, -00135, -00137, and -00138, in
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`which U.S. Patent Nos. 8,048,032; RE45,380; RE45,760; RE45,776, and
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`RE47,379 were at issue.
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`I am being compensated at $525 per hour for my time, my standard
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`rate for this type of consulting activity. My compensation is not contingent on the
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`results of these or any other legal proceedings.
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`II. MATERIALS CONSIDERED
`In writing this declaration, I have considered my own knowledge and
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`experience, including my work experience in designing medical devices including
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`catheters and my experience in working with others involved in the field of
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`interventional cardiology devices, including medical doctors working as
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`interventional cardiologists. I have also considered the information that a person
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`of ordinary skill in the art (“POSITA”) would have been aware of as of the date of
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`invention, including the documents I discuss in this declaration.
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`I have also reviewed the patent at issue in these inter partes reviews
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`and its file history, as well as the other six GuideLiner patents and their file
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`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 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 reviewed the Institution Decisions issued by the Patent Trial
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`and Appeal Board in each of the IPR2020-01341, 01342, 01343, and 01344
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`matters.
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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 IPR2020-01341.
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`III. LEGAL STANDARDS
`I am not an attorney and I have not independently researched the law
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`on patentability. I have been informed by counsel of the legal standards below.
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`A. Claim Construction
`I understand that patent claims are to be interpreted in view of a
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`patent’s specification and prosecution history. I understand that claim construction
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`starts with the plain language of the claims as understood by a person having
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`ordinary skill in the art at the time the patent was filed.
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`I understand that a patent may be its own lexicographer, so long as
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`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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`B. Anticipation
`I understand that a claim is invalid as anticipated if a single prior art
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`reference discloses each and every limitation of the claimed invention.
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`I understand that a reference may be anticipatory regardless of
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`whether the prior art and the claimed invention are directed to achieving the same
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`purpose, if it contains the claim elements as claimed and would inherently provide
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`any claimed function.
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`I understand that a prior art reference may anticipate a claim without
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`expressly disclosing a feature of the claimed invention if that missing feature is
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`necessarily present, or inherent, in the single anticipating reference.
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`6
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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 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
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`art; (3) the level of ordinary skill in the art; and (4) objective indicia of
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`nonobviousness.
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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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`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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`7
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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
`I have been asked only to provide my independent opinions and
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`analysis of the issues I specifically discuss in this declaration. I note that the
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`Petition (and the evidence it cites) appears to raise many other issues, but I have
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`not been asked to provide my opinions as to any of those other issues.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
`I understand that the Petitioner and Dr. Brecker have proposed a
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`definition of a POSITA: “a person of ordinary skill in the art (“POSITA”) at the
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`time of the alleged invention would have had (a) a medical degree; (b) completed
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`a coronary intervention training program, and (c) experience working as an
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`8
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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
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`and technical training might substitute for education, and advanced degrees might
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`substitute for experience. Additionally, a POSITA with a medical degree may have
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`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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`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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`9
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`a POSITA in May 2006. However, I also have reviewed evidence showing that
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`the 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 ’413 PATENT
`A. 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
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`particular with catheter technology, I have become very familiar with coronary
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`catheter procedures and the devices used for those procedures. The following
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`paragraphs provide an overview of heart disease, coronary catheters, and coronary
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`catheter 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
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`the heart muscle via the coronary arteries (see diagram below). Over time, these
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`10
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`blood 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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` 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
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`regions of the heart muscle. (See below—A.) Severe lesions can dramatically
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`restrict the blood flow, starving the muscle of oxygen (ischemia), which can create
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`severe chest pain and significantly limit a patient’s activity and quality of life. If
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`the lesion completely blocks the flow of blood (typically from a subsequent blood
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`11
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`clot 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
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`patient may die if the blocked vessel is not re-opened quickly, i.e., within hours of
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`the blockage.
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` Since at least the early 1990s, the most common treatment for CAD
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`is with catheter devices that dilate the blockage from inside and place a support
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`scaffold (stent) therein. The stent is inserted across the lesion in a collapsed state
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`and then dilated with a balloon-tipped catheter called an angioplasty catheter (see
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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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`12
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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
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`circumflex “LCX.” The RCA extends down the right side of the heart. The RCA,
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`LAD, and LCX are considered the three primary coronary arteries. Each of these
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`arteries, in turn, has numerous side branches, which then further branch ultimately
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`into the capillary beds where the actual transfer of oxygen to heart muscle tissue
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`13
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`
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`takes place (see figure below). Most lesions requiring treatment are within these
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`three primary arteries, or occasionally a major branch stemming therefrom.
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` Beyond the coronary arteries, the aorta has numerous branches and
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`sub-branches as it feeds oxygenated blood to the rest of the body. (See diagram
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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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`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
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`and radial arteries are relatively close to the skin surface, and one or the other is
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`14
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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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`In the following paragraphs, I will describe a typical coronary
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`catheter treatment procedure. Many variations of the procedure exist, but this
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`description of a typical and common procedure will serve to illustrate the issues
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`pertinent to 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
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`into this vessel (see below). The introducer sheath is a relatively short tubular
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`access catheter, approximately 20 cm long. Its purpose is primarily to maintain an
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`access pathway into the femoral artery to facilitate the rest of the procedure. A
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`slitted seal is provided on the back (proximal) end of the sheath to keep blood
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`from exiting. The appropriate sheath size depends on numerous factors, including
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`the 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
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`injecting an x-ray visible contrast solution through the catheter into the main
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`coronary vessels and one or more of the pumping chambers of the heart. This
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`technique identifies the location of any blockages or narrowings that may require
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`treatment with angioplasty catheters, as well as any defects in the valves that
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`separate the chambers of the heart. Sometimes this diagnostic catheterization
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`procedure is performed as a separate procedure.
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` After the sheath is placed and the diagnostic procedure is complete,
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`to treat the lesion a device called a guide catheter (also called a “guiding catheter”,
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`or 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
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`curve of the aortic arch is reached. This wire is then removed. The primary
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`purpose of the guide catheter is to provide a stable access route for coronary
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`devices and a lumen for delivery of x-ray contrast fluid for visualizing the vessel
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`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
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`braid which facilitates “torquability” by enhancing the torsional stiffness. (See
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`below—A.) Guide catheters also have pre-set curves near the distal tip, to aid in
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`placement within the aortic arch and into the ostium. (See below—B.) There are
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`numerous curve shapes offered by many manufacturers. (See below—C.) The
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`combination of stiffness characteristics, torsional characteristics, and curve shapes
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`aids in the ability to successfully intubate the ostium of a particular individual.
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`Every person’s arch and ostium anatomy is different. Therefore, accessing each
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`ostium 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 (IPR2020-01341), 3:11-26. This is not
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`unusual or surprising because, as I noted above, guide catheters were typically
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`sized according to their outer diameter, whereas the inner diameter varies
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`depending not just on outer diameter, but also on wall thickness. Therefore, a
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`POSITA would interpret a “one French size” difference consistently with the
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`specification, rather than in accordance with the strict mathematical definition of
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`“French.” Thus, for example, when a guide extension catheter having an internal
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`diameter of at least 0.056 inches is used with a 6 French guide catheter (which
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`would typically have an external diameter of ~0.079 inches and an internal
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`diameter of ~ 0.070-0.071 inches), the guide extension catheter is used with a
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`guide catheter that is one French size different.
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` 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