UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`Case IPR2020-01341
`Case IPR2020-01342
`Patent 8,142,413
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`DECLARATION OF PETER T. KEITH
`IN SUPPORT OF MOTIONS TO AMEND
`U.S. PATENT 8,142,413
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-01341
`Case IPR2020-01342
`Patent 8,142,413
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`DECLARATION OF PETER T. KEITH
`IN SUPPORT OF MOTIONS TO AMEND
`U.S. PATENT 8,142,413
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`TABLE OF CONTENTS
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`PERSONAL BACKGROUND ....................................................................... 1
`I.
`II. MATERIALS CONSIDERED ........................................................................ 4
`III. LEGAL STANDARDS ................................................................................... 5
`A. Claim Construction................................................................................ 5
`B. Written Description ............................................................................... 5
`IV. SCOPE OF OPINIONS ................................................................................... 6
`V. PERSON OF ORDINARY SKILL IN THE ART .......................................... 6
`VI. THE TELEFLEX PATENTS .......................................................................... 7
`VII. WRITTEN DESCRIPTION ..........................................................................11
`A. Substitute Claim 15 .............................................................................11
`B.
`Substitute Claim 16 .............................................................................16
`C.
`Substitute Claim 17 .............................................................................18
`VIII. NEXUS ..........................................................................................................18
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`i
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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 and other
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`Teleflex patents, which I refer to as the “GuideLiner patents.” I submit this
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`declaration in support of Teleflex’s Motion to Amend U.S. Patent No. 8,142,413.
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`I.
`
`PERSONAL BACKGROUND
`I summarize my educational background and career history in the
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`following paragraphs. My complete qualifications are provided in my curriculum
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`vitae, which is attached to this declaration as Appendix A.
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`
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`I received a Bachelor of Science degree in mechanical engineering
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`with High Distinction from the University of Minnesota in 1987. During my
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`undergraduate training, I began working as an engineering intern in the research
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`and development (R&D) department at SCIMED, which was later acquired by
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`Boston Scientific Corporation. I joined SCIMED full-time after graduation, and I
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`remained with the company until 1996. During this time I rose from engineering
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`intern to full-time R&D engineer to Director of R&D. Throughout my various
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`roles at SCIMED, the focus of my work was on medical devices in the field of
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`interventional cardiology, particularly catheter design.
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`1
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`Since 1997, I have served as an independent consultant for early stage
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`medical device companies in the areas of product design and intellectual property
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`development. Many of my consulting clients and/or the products they developed
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`with my assistance were subsequently acquired by large medical technology
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`companies, including St. Jude Medical/Abbott, Johnson & Johnson, Teleflex,
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`Edwards Lifesciences and LivaNova. A number of the products that 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 interventional
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`cardiology. I have also done considerable work outside the area of interventional
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`cardiology, including in treatments for orthopedics for extremities such as feet and
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`ankles and treatment of spinal disorders. In 2006, I co-founded Entellus Medical, a
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`company focused on catheter-based treatments for chronic sinusitis. As Chief
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`Technology Officer, I led the product development and research teams. Entellus
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`successfully commercialized a series of ground-breaking products developed under
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`my leadership. Entellus went public in 2015, and was acquired by Stryker in 2018
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`for over $600 million.
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`2
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`Between my work at SCIMED, my independent consulting, and my
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`entrepreneurial ventures, I have been named as an inventor on over 140 issued U.S.
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`patents, as well as many corresponding patents in foreign countries. Numerous
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`additional 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 prior experience with patent litigation involving the technology
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`at issue and the GuideLiner patents. Among other things, I provided expert
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`analysis on behalf of Teleflex in the case of QXMédical, LLC v. Vascular Solutions
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`LLC, et al., No. 0:17-cv-01969 (D. Minn.) (the QXM case). In the QXM case,
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`among the patents asserted were four of the five GuideLiner patents at issue in
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`these IPRs: U.S. Patent Nos. 8,048,032; RE45,380; RE45,760; and RE45,776.
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`U.S. Patent No. RE47,379 had not yet issued when the QXM case was filed, but it
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`is in the same family as the other four patents listed above that were asserted in the
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`QXM case.
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`I also provided expert opinions concerning the GuideLiner patents at
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`issue in these IPRs on behalf of Teleflex in the case of Vascular Solutions LLC, et
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`al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.), in connection with
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`Teleflex’s Motion for Preliminary Injunction.
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`3
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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 of the GuideLiner patents, including the documents I discuss in this
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`declaration.
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`I have also reviewed the ’413 patent and its file history.
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`I reviewed the Petitions filed in the IPR2020-01341 and IPR2020-
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`01342 matters, the declarations of Dr. Brecker and Dr. Hillstead that accompanied
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`these Petitions, and the documents cited in the declarations. I also have reviewed
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`the Institution Decisions issued by the Patent Trial and Appeal Board for IPR2020-
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`01341 and IPR2020-01342.
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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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`4
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`III. LEGAL STANDARDS
`I am not an attorney and I have not independently researched the law
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`on patentability. I have been informed by counsel of the legal standards below.
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` Claim Construction
`I understand that patent claims are to be interpreted in view of a
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`patent’s specification and prosecution history. I understand that claim construction
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`starts with the plain language of the claims as understood by a person having
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`ordinary skill in the art at the time the patent was filed. I understand that a
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`patentee may be his/her own lexicographer, so long as the definition of a specific
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`term is clearly set forth in the specification and it is clear the inventor intended to
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`define the term.
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`B. Written Description
`I have been informed that a patent’s specification must contain an
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`adequate written description of the claimed invention. I have been informed that
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`the standard for assessing the adequacy of the written description is whether the
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`description reasonably would convey to a POSITA that the inventor(s) had
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`possession of the claimed subject matter by the filing date of the original
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`application. I have been informed that the written description requirement may be
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`satisfied by any combination of the words, structures, figures, diagrams, formulas,
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`etc., contained in a patent, and that drawings, in particular, constitute an adequate
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`5
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`description if they describe, and convey to those of skill in the art that the patentee
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`invented, what is claimed.
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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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`Petitions (and the evidence they cite) appear 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 for this
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`declaration.
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`I am not aware of any prior art that is closer to the substitute claims in
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`Teleflex’s motions to amend than that raised in the present IPR proceedings. No
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`prior art known to me, including that cited by Petitioner in these IPR proceedings,
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`describes what is recited in the substitute claims presented in the motion to amend
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`the ’413 patent. It is my opinion that the substitute claims in Teleflex’s motions to
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`amend are patentable over the prior art of which I am aware.
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`V.
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`PERSON OF ORDINARY SKILL IN THE ART
`I provide my opinions with respect to the definition of a POSITA
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`offered by Petitioner, e.g., IPR2020-01341 Petition, 11-12, which I meet.
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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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`6
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`understand that this date is no later than May 3, 2006, the date on which the
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`earliest patent application for the family of GuideLiner patents was filed.
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`Therefore, when I provide my opinions, I note that they are from the perspective of
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`a POSITA in May 2006. My opinions would be the same if the relevant date of
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`invention is sometime in 2005, rather than May 2006.
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`VI. THE TELEFLEX PATENTS
` The Teleflex patents describe the invention of a “coaxial guide
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`catheter” that is designed for use with interventional cardiology devices. IPR2020-
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`001341, Ex-1003, 49.1 The coaxial guide catheter, which is also known as a guide
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`extension catheter and is embodied by the GuideLiner products, increases the
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`backup support for catheters that are inserted into the coronary arteries from the
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`aorta. Id., 3:10-12. As described in the disclosure, the guide extension catheter of
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`the invention generally includes, from distal to proximal direction, a soft tip
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`portion, a tubular portion, and a substantially rigid portion that has a rail segment
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`to permit delivery without blocking use of the guide catheter. E.g., id., 32:4-5,
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`Figs. 1, 4, 20-22. One advantage this design has is that it only minimally reduces
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`11 All citations in this declaration to the application for the ’413 patent are to
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`IPR2020-01341, Ex-1003. These citations are in the form, e.g., “Ex-1003, XX,”
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`where XX is the page of Exhibit 1003 rather than the page of the application.
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`7
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`the available space inside the lumen of the guide extension to deliver interventional
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`cardiology devices—by no more than one French size smaller than the guide
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`catheter in the preferred embodiment. Id., 25:8-18.
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` The guide extension catheter has structure designed to facilitate the
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`insertion of interventional cardiology devices, including stent and balloon
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`catheters, into its proximal end while the guide extension catheter is inside a
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`standard guide catheter. The specification explains that the guide extension
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`catheter preferably has a full circumference portion (34, blue), a hemicylindrical
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`portion (36, green), and an arcuate portion (38, purple):
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`Id., 33:6-14, Fig. 4 (color added). Inclined portions can be seen on either side of
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`the non-inclined hemicylindrical portion 36.
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` The guide extension catheter is designed to be used with a
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`conventional guide catheter. Id., 39:19-40:10. First, the guide catheter is inserted
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`through the vasculature and seated in the ostium of a smaller branch vessel. Id.,
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`39:19-40:1. Then the guide extension catheter (along with an optional protective
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`“inner catheter” that functions to protect the vasculature from the distal end of the
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`guide extension catheter) is inserted into the guide catheter. Id., 40:1-7. The
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`combination of the guide extension catheter and the protective inner catheter is
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`8
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`inserted through the guide catheter until the distal end of the guide extension
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`catheter emerges from the distal end of the guide catheter and travels deeper into
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`the branch vessel. Id. Then, the protective inner catheter is withdrawn. Id., 40:7-
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`8. Finally, an interventional cardiology device such as a stent or balloon catheter is
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`inserted into the lumen of the guide catheter, travels down the guide catheter and
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`then into the lumen of the coaxial guide extension catheter, and finally out the
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`distal end of the guide extension catheter to a desired location of treatment. Id.,
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`40:7-18.
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` One of the important benefits of the invention is increased “backup
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`support.” This is important to countering the guide catheter back-out problem with
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`complex coronary stenosis. As the patents teach, when treating a stenosis, a guide
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`catheter is typically guided into the ostium (opening) of the branch artery to be
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`treated, and a guidewire is passed through the lumen of the guide catheter and
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`advanced into the artery beyond the stenosis. Id., 21:16-22:2.
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`
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`I have reproduced Figure 7 from the disclosure below, adding color to
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`show a typical guide catheter 56 (pink) inserted into the ostium 60 of a coronary
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`artery, with a guidewire 64 passing through the guide catheter and attempting to
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`cross a stenotic lesion 66:
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`9
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`Id., 34:20-35:8. When the wire or an interventional cardiology device such as a
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`stent or balloon catheter runs into a difficult or complex lesion, pushing it within or
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`across the lesion can create backward force strong enough to dislodge the guide
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`catheter’s distal end from the ostium. Id., 22:2-3, 28:14-19. The phantom guide
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`catheter (yellow) in Figure 7 shows how backward force generated by the
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`advancing device can cause the guide catheter to dislodge or back out from the
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`ostium.
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` The guide extension catheter, inserted beyond the end of the guide
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`catheter deeper into the branch vessel, provides increased backup support for the
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`guide catheter inserted into a coronary artery and prevents this problem. Id., 21:2-
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`4. In Figure 9 from the patents, I illustrate how the guide extension catheter 12
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`10
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`(orange with blue tip) is inserted past the distal end of the guide catheter and deep
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`into the coronary artery:
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`
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`VII. WRITTEN DESCRIPTION
`I have been asked to provide my opinions as to whether the Teleflex
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`patents provide adequate written description for elements claimed in the patents.
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`It is my opinion that the priority application discloses all elements of
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`all claims, as set forth below.
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`A.
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`
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`Substitute Claim 15
`I understand that substitute claim 15 reads as follows:
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`Substitute claim 15 (replaces claim 1). A method of providing backup
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`support for a treatment catheter that includes a stent an interventional cardiology
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`device for use in the coronary vasculature, the treatment catheter that includes a
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`11
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`stent interventional cardiology device being adapted to be passed through a
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`standard guide catheter, the standard guide catheter having a continuous lumen
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`extending for a predefined length from a proximal end at a hemostatic valve to a
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`distal end adapted to be placed in an ostium of a branch artery that branches off
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`from a first artery, the continuous lumen of the standard guide catheter having a
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`circular cross-sectional inner diameter sized such that the treatment catheter that
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`includes a stent is interventional cardiology devices are insertable into and through
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`the continuous lumen, the method comprising the following steps in the order
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`recited:
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`inserting the standard guide catheter into [[a]] the first artery over a
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`guidewire, the standard guide catheter having a distal end;
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`positioning the distal end of the standard guide catheter in [[a]] the ostium of
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`the branch artery that branches off from the first artery;
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`inserting a cylindrical flexible tip portion of a coaxial guide catheter, the
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`flexible tip portion defining a tubular structure having a circular cross-section with
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`a single lumen that is coaxial with the lumen of the standard guide catheter, an
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`inner diameter not more than about one French smaller than the inner diameter of
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`the standard guide catheter, a cross-sectional outer diameter, and a length that is
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`shorter than the predefined length of the continuous lumen of the standard guide
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`catheter, into the continuous lumen of the standard guide catheter, and,
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`12
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`further inserting a substantially rigid portion of the coaxial guide catheter
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`that is proximal of, operably connected to, and more rigid along a longitudinal axis
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`than the flexible tip portion, into the continuous lumen of the standard guide
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`catheter, the substantially rigid portion defining a rail structure without a lumen
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`and having a maximal cross-sectional dimension at a proximal portion that is
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`smaller than the cross-sectional outer diameter of the flexible tip portion and
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`having a length that, when combined with the length of the flexible distal tip
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`portion, defines a total length of the coaxial guide catheter device along the
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`longitudinal axis that is longer than the length of the continuous lumen of the
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`standard guide catheter, wherein a distal portion of the substantially rigid portion
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`includes a side opening that is sized and configured to receive the treatment
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`catheter that includes a stent;
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`advancing a distal portion of the flexible tip portion distally beyond the
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`distal end of the standard guide catheter and into the branch second artery such that
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`the distal portion of the flexible tip portion extends into the branch second artery
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`and such that at least a portion of the proximal portion of the substantially rigid
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`portion extends proximally through the hemostatic valve; and
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`inserting the interventional cardiology device treatment catheter that
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`includes a stent into and through the continuous lumen of the standard guide
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`catheter alongside the rail structure of the substantially rigid portion and advancing
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`13
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`the interventional cardiology device treatment catheter that includes a stent through
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`the side opening and beyond [[a]] the single lumen of the flexible tip portion into
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`contact with or past a lesion in the branch second artery.
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`
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`It is my opinion that all elements of substitute claim 15 are supported
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`by the application. Specifically, the priority application discloses a method of
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`providing backup support for a treatment catheter that includes a stent for use in
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`the coronary vasculature and is adapted to be passed through a standard guide
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`catheter. Ex-1003, 25:5-7; 28:1-29:12; 30:13-20; 34:20-36:10; 39:19-40:18; 55-
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`57.
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` The priority application further discloses that the standard guide
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`catheter has a continuous lumen that extends for a predefined length from a
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`proximal end at a hemostatic valve to a distal end adapted to be placed in an
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`ostium of a branch artery that branches off from a first artery, where the continuous
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`lumen of the standard guide catheter has a circular cross-sectional inner diameter
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`sized such that the treatment catheter that includes a stent is insertable into and
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`through the continuous lumen. Id., 21:26-22:2; 25:3-18; 28:1-19; 29:15-16; 30:13-
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`15; 34:20-35:12; 55.
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` The application discloses that the method includes a series of
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`sequential steps that includes inserting the standard guide catheter into the first
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`artery over a guidewire, positioning the distal end of the standard guide catheter in
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`14
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`the ostium of the branch artery, id., 21:25-22:2; 27:17-28:6; 28:14-19; 30:13-15;
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`34:20-35:8; 39:19-40:10; 55, and then inserting a cylindrical flexible tip portion of
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`a coaxial guide catheter into the continuous lumen of the standard guide catheter,
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`id., 24:14-16; 26:3-16; 27:17-28:6; 30:1-2, 5-6, 9-10, 16-18; 32:4-20; 35:13-20;
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`40:1-8; 50; 52; 54; 56, where the flexible tip portion defines a tubular structure
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`having a circular cross-section with a single lumen that is coaxial with the lumen
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`of the standard guide catheter and has an inner diameter not more than about one
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`French smaller than the inner diameter of the standard guide catheter, a cross-
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`sectional outer diameter, and a length that is shorter than the predefined length of
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`the continuous lumen of the standard guide catheter, id., 25:8-18; 26:5-16; 30:1-2,
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`5-6; 31:6; 32:2-20; 50; 52; 59 at Figure 14.
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` The application discloses then inserting a substantially rigid portion of
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`the coaxial guide catheter into the continuous lumen of the standard guide catheter,
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`id., 30:1-2; 33:1-3; 39:19-40:10; 50, where the substantially rigid portion is
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`proximal of, operably connected to, and more rigid along a longitudinal axis than
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`the flexible tip portion, defines a rail structure without a lumen, and has a maximal
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`cross-sectional dimension at a proximal portion that is smaller than the cross-
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`sectional outer diameter of the flexible tip portion and a length that, when
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`combined with the length of the flexible distal tip portion, defines a total length of
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`the coaxial guide catheter along the longitudinal axis that is longer than the length
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`15
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`
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`of the continuous lumen of the standard guide catheter, wherein a distal portion of
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`the substantially rigid portion includes a side opening that is sized and configured
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`to receive the treatment catheter that includes a stent, id., 24:14-16; 25:3-7; 26:3-6;
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`26:17-27:5; 28:3-19; 29:15-18; 30:1-2, 7-8, 13-15; 31:4-8; 32:4-5; 34:4-19; 37:7-
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`13; 39:19-40:18; 50; 53; 55; 59.
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` The priority application also discloses then advancing a distal portion
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`of the flexible tip portion distally beyond the distal end of the standard guide
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`catheter and into the branch artery such that the distal portion of the flexible tip
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`portion extends into the branch artery and such that at least a portion of the
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`proximal portion of the substantially rigid portion extends proximally through the
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`hemostatic valve, and inserting the treatment catheter that includes a stent into and
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`through the continuous lumen of the standard guide catheter alongside the rail
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`structure of the substantially rigid portion and advancing the treatment catheter that
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`includes a stent through the side opening and beyond the single lumen of the
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`flexible tip portion into contact with or past a lesion in the branch artery, id.,
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`24:14-16; 25:3-7; 28:7-13; 29:16-18; 30:16-20; 36:1-10; 39:19-40:10; 56; 57.
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`B.
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`
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`Substitute Claim 16
`I understand that substitute claim 16 reads as follows:
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`Substitute claim 16 (replaces claim 7). The method as claimed in claim [[1]]
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`15, such that when further comprising extending a distal portion of the tubular
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`16
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`
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`structure is extended beyond the distal end of the standard guide catheter while a
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`proximal portion of the tubular structure remains within the lumen of the standard
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`guide catheter, such that the coaxial guide catheter assists in resisting axial and
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`shear forces exerted by the treatment catheter that includes a stent when
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`interventional cardiology device passed through and beyond the coaxial lumen that
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`would otherwise tend to dislodge the standard guide catheter from the branch
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`artery, wherein the standard guide catheter is a standard 6 French guide catheter,
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`and wherein the inner diameter of the tubular structure is at least 0.056 inches.
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`
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`It is my opinion that all elements of substitute claim 16 are supported
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`by the application. Specifically, the priority application discloses that, when a
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`distal portion of the tubular structure is extended beyond the distal end of the
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`standard guide catheter while a proximal portion of the tubular structure remains
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`within the lumen of the standard guide catheter, the coaxial guide catheter assists
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`in resisting axial and shear forces exerted by the treatment catheter that includes a
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`stent when passed through and beyond the coaxial lumen that would otherwise
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`tend to dislodge the standard guide catheter from the branch artery. Ex-1003, 28:1-
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`29:12; 30:13-20; 15:4-36:10; 40:11-18; 55-57.
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` The priority application further discloses that the guide catheter can be
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`a standard 6 French guide catheter and that the inner diameter of the tubular
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`structure is at least 0.056 inches. Id., 25:8-18.
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`17
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`
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`C.
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`
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`Substitute Claim 17
`I understand that substitute claim 17 reads as follows:
`
`Substitute claim 17 (replaces claim 8). The method of claim 16[[7]], further
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`comprising extending the interventional cardiology device wherein advancing the
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`treatment catheter that includes a stent through the side opening includes
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`advancing the treatment catheter that includes a stent past two inclined sidewalls
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`spaced apart by a non-inclined concave track, and extending the treatment catheter
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`that includes a stent past a radiopaque marker proximate a distal tip of the coaxial
`
`guide catheter.
`
`
`
`It is my opinion that all elements of substitute claim 17 are disclosed
`
`in the application. Specifically, the application discloses extending the treatment
`
`catheter that includes a stent through a side opening that includes two inclined
`
`sidewalls spaced apart by a non-inclined concave track. Ex-1003, 26:18-27:5;
`
`30:7-8, 11-12; 31:4-8; 33:1-14; 34:15-19; 37:7-13; 53; 54; 59.
`
`
`
`It further discloses extending the treatment catheter that includes a
`
`stent past a radiopaque marker proximate a distal tip of the coaxial guide catheter.
`
`Id., 25:19-26:2; 26:7-11; 32:7-13.
`
`VIII. NEXUS
`I have been asked to provide my opinions as to whether there is a
`
`
`nexus between the invention claimed in substitute claims 15 and 17 and the
`
`18
`
`
`
`objective evidence of nonobviousness. Specifically, I have been asked whether
`
`claim 15 or 17 of the ’413 patent literally reads on the GuideLiner products.
`
` Based on my review of the claims, the information provided to me in
`
`connection with these IPRs, my familiarity with the GuideLiner products, and my
`
`manual inspection of the three versions of the GuideLiner products, it is my
`
`opinion that claim 15 literally covers all three versions of GuideLiner and that
`
`claim 17 literally covers GuideLiner V3, as explained in Appendix B and below.
`
`GuideLiner is not merely a component, part, or feature of the claimed invention; it
`
`embodies the full claimed invention.
`
` Based on my understanding from the declarations of Dr. Graham, Dr.
`
`Azzalini, and Dr. Thompson and my conversation with Dr. Graham, as well as my
`
`own understanding of the GuideLiner product and its use, the GuideLiner provided
`
`very important clinical benefits: GuideLiner’s use allowed physicians, for the first
`
`time, to take advantage of a specialty catheter that provided the necessary backup
`
`support as well as “rapid exchange” functionality and real-estate maximizing
`
`design that allowed physicians to receive and deliver the full array of
`
`interventional cardiology devices (including stents) deep into the vasculature. Ex-
`
`2145, ¶¶76-77, 85-91, 223-24 (Declaration of Dr. Graham); Ex-2151 (Declaration
`
`of Dr. Azzalini); Ex-2215, ¶¶21-25 (Declaration of Dr. Thompson).
`
`19
`
`
`
` The combination of steps recited in independent substitute claim 15
`
`provided these benefits. The “rapid exchange” functionality is reflected in claim
`
`15’s requirement of inserting a treatment catheter that includes a stent through the
`
`guide catheter, alongside the coaxial guide catheter’s substantially rigid segment,
`
`while maintaining the coaxial guide catheter’s distal portion beyond the end of the
`
`guide catheter. Claim 15 recites the rapid exchange structure, stating, “inserting a
`
`cylindrical flexible tip portion of a coaxial guide catheter” that has “a cross-
`
`sectional outer diameter, and a length that is shorter than the predefined length of
`
`the continuous lumen of the standard guide catheter” into the guide catheter, and
`
`“further inserting a substantially rigid portion of the coaxial guide catheter that is
`
`proximal of, operably connected to” “and having a maximal cross-sectional
`
`dimension at a proximal portion that is smaller than the cross-sectional outer
`
`diameter of the flexible tip portion” into the guide catheter, where “the
`
`substantially rigid portion defin[es] a rail structure without a lumen and ha[s] a
`
`length that, when combined with the length of the flexible distal tip portion,
`
`defines a total length of the coaxial guide catheter along the longitudinal axis that
`
`is longer than the length of the continuous lumen of the standard guide catheter.”
`
` The ability to receive the full array of interventional cardiology
`
`devices (including stents) deep into the vasculature directly results from the
`
`combination of several claimed features, including claim 15’s requirement that
`
`20
`
`
`
`“the flexible tip portion defin[es] a tubular structure . . . with a single lumen that is
`
`coaxial with the lumen of the standard guide catheter [and has] an inner diameter
`
`not more than about one French smaller than the inner diameter of the standard
`
`guide catheter,” as well as claim 15’s requirement of inserting a substantially rigid
`
`portion of the coaxial guide catheter “into the continuous lumen of the standard
`
`guide catheter” “wherein a distal portion of the substantially rigid portion includes
`
`a side opening that is sized and configured to receive the treatment catheter that
`
`includes a stent.”
`
` The improved backup support results from the combination of several
`
`claimed features, including at least the use of a flexible tip portion having a
`
`circular cross section with a diameter that fits within the guide catheter and the
`
`claimed step of advancing the distal portion of the flexible tip portion beyond the
`
`distal end of the guide catheter while the remainder is inside the guide catheter.
`
`Specifically, claim 15 requires “inserting a cylindrical flexible tip portion of a
`
`coaxial guide catheter, the flexible tip portion defining a tubular structure having a
`
`circular cross-section . . . into the continuous lumen of the standard guide
`
`catheter,” and “advancing a distal portion of the flexible tip portion distally beyond
`
`the distal end of the standard guide catheter and into the branch artery such that the
`
`distal portion of the flexible tip portion extends into the branch artery and such that
`
`at least a portion of the proximal portion of the substantially rigid portion extends
`
`21
`
`
`
`proximally through the hemostatic valve.” This method results in improved
`
`backup support (over the guide catheter alone) due to the combination of the
`
`tubular portion being deep seated in the vasculature (beyond the end of the guide
`
`catheter), the interaction between the portion of the tubular portion still inside the
`
`guide catheter and the guide catheter walls, the configuration of the tubular
`
`structure and its size relative to the guide catheter (including the tubular portion
`
`having “a single lumen that is coaxial with the lumen of the standard guide catheter
`
`[and] an inner diameter not more than about one French smaller than the inner
`
`diameter of the standard guide catheter”), and the substantially rigid portion
`
`allowing the cardiologist to control the tubular portion.
`
`
`
`In addition to the combination of steps recited in claim 15, claim 17
`
`further recites “advancing the treatment catheter that includes a stent through the
`
`side opening includes advancing the treatment catheter that
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