`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 IPR2020-00131
`Patent RE 45,380E
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`DECLARATION OF PETER T. KEITH
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`I, Peter Keith, hereby declare and state as follows:
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`1.
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`I have been retained by the owner of U.S. Patent No. RE45,380 (“the
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`’380 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 petitions for inter
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`partes review have been filed against certain claims of the ’380 patent. The
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`following provides my opinions in support of Teleflex’s Patent Owner Preliminary
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`Response in this matter.
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`I.
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`PERSONAL BACKGROUND
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`2.
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`I summarize my educational background and career history in the
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`following paragraphs. My complete qualifications are provided in my curriculum
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`vitae, which is attached hereto as Appendix A.
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`3.
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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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`4.
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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. Several of my consulting clients have developed successful products
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`that are on the market and in hospitals today. A number of the products have been
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`in the field of interventional cardiology, particularly catheters.
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`5.
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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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`went public in 2015, and was acquired by Stryker in 2018.
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`6.
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`Between my work at SCIMED, my independent consulting, and my
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`entrepreneurial ventures, I have been named as an inventor on over 140 issued U.S.
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`patents, as well as many corresponding patents in foreign countries. Numerous
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`patent applications on which I am a named inventor are still pending.
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`2
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`7.
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`I have prior experience with patent litigation involving the technology
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`at issue and the patent families at issue in this case. Among other things, I
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`provided expert infringement and validity opinions on behalf of Teleflex in the
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`case of QXMédical, LLC v. Vascular Solutions LLC, et al., No. 0:17-cv-01969 (D.
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`Minn.) (the QXM case). In the QXM case, among the patents asserted were four
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`of the five patents at issue in these IPRs: U.S. Patent Nos. 8,048,032; RE45,380;
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`RE45,760; and RE45,776. U.S. Patent No. RE47,379 had not yet issued when the
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`QXM case was filed, but it is in the same family as the other four patents listed
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`above that were asserted in the QXM case.
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`8.
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`I have also provided expert opinions concerning all five patents at
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`issue in these proceedings on behalf of Teleflex in the case of Vascular Solutions
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`LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.). Those opinions
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`were provided in connection with Teleflex’s Motion for Preliminary Injunction.
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`9.
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`In writing this declaration, I have considered my own knowledge and
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`experience, including my work experience in designing interventional cardiology
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`devices 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.
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`10.
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`I have also considered the information that a POSITA would have
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`been aware of in May 2006, including the documents I discuss in this declaration.
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`3
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`11.
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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. LEGAL STANDARDS
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`12.
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`I am not an attorney and I have not independently researched the law
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`on patentability. I have been informed by counsel of the legal standards below.
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`A. Claim Construction
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`13.
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`I understand that patent claims are to be interpreted in view of a
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`patent’s specification and prosecution history. I understand that claim construction
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`starts with the plain language of the claims as understood by a person having
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`ordinary skill in the art at the time the patent was filed.
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`14.
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`I understand that the parties agreed to constructions for certain claim
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`terms in the QXM case. I understand that those constructions are provided in the
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`document filed by the Petitioner in this inter partes review as Exhibit 1812. Other
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`than as specifically discussed in this declaration, I do not at this time offer any
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`opinions regarding those constructions. Rather, I apply them for the purpose of
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`this declaration.
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`15.
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`I understand that a patent may be its own lexicographer, so long as the
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`definition of a specific term is clearly set forth in the specification and it is clear
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`the inventor intended to define the term.
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`4
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`16. For any claim terms not explicitly noted as construed, I have applied
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`the plain and ordinary meanings as would be understood by a person of ordinary
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`skill in the art in 2006.
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`17.
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`I understand that certain claim language may be considered “means-
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`plus-function” claim language, and in such a case that the claim would cover the
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`structure disclosed in the specification for performing the claimed function and
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`equivalents thereof. I also understand that a consideration in deciding whether a
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`claim limitation is construed to be a “means-plus-function” claim limitation is
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`whether the claim recites sufficient structure to perform the claimed function in its
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`entirety. I also understand that sufficient structure exists when the claim language
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`specifies the exact structure that performs the functions in question without the
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`need to resort to other portions of the specification or extrinsic evidence for an
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`adequate understanding of the structure.
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`18. Regarding the “means for guiding an interventional device from
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`outside of a subject, through a main vessel, to a location near an ostium of a branch
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`vessel” limitation of claim 25 of the ‘380 patent, for purposes of this declaration I
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`have accepted Medtronic’s construction that the limitation is a “means-plus-
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`function” claim limitation and that the disclosed structure for performing the
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`function of “guiding an interventional device from outside of a subject, through a
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`main vessel, to a location near an ostium of a branch vessel” is a guide catheter.
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`5
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`19. Regarding the “means for receiving the interventional device from an
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`intermediate or distal portion of the means for guiding the interventional device to
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`the location near the ostium of the branch vessel and guiding the interventional
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`device deeper into the branch vessel” limitation of claim 25 of the ‘380 patent, I do
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`not believe that the claim recites sufficient structure to perform the claimed
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`function. The claim states that the recited means includes, in a distal to proximal
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`direction, “a tip portion, a reinforced portion, a side opening, and a substantially
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`rigid portion, and having a length such that when the distal end of the tip portion is
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`extended distally of the distal end of the means for guiding the interventional
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`device to the location near the ostium of the branch vessel, a portion of the
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`proximal end of the substantially rigid portion extends proximally of the proximal
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`end of the means for guiding the interventional device to the location near the
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`ostium of the branch vessel.” However, I do not believe that the words of the
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`claims themselves, without resorting to the specification, recite sufficient structure
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`to perform the claimed function of “receiving the interventional device and guiding
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`the interventional device deeper into the branch vessel.”
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`20. For example, claim 25 does not recite a tubular structure with a lumen
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`into which an interventional device can be received and be guided “deeper into the
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`branch vessel.” This structure is necessary to provide the function of receiving and
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`“guiding the interventional device deeper into the branch vessel.” Because it is my
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`6
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`opinion that the claim does not recite sufficient structure to perform the claimed
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`function, I understand the “means for receiving” limitation to be a “means-plus-
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`function” claim limitation.
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`21. The structure disclosed in all embodiments of the ‘380 patent for
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`performing the function of “receiving the interventional device and guiding the
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`interventional device deeper into the branch vessel” is the coaxial guide extension
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`catheter having a tubular portion with a single lumen that has a circular cross-
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`section that is attached at its distal end to a tip having a lumen with a circular
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`cross-section, and attached at its proximal end to a substantially rigid pushrod
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`structure, with an opening (which can have various configurations depending on
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`the embodiment) located at the junction between the tubular portion and the
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`substantially rigid pushrod structure. The disclosed coaxial guide extension
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`catheter’s lumen is coaxial with that of the guide catheter, at least a distal part of
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`the tubular portion is flexible, and the total length of the coaxial guide extension
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`catheter is longer than that of the guide catheter. Numerous specific examples of
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`all or part of this structure are shown in Figures 1-4, 9-16, and 20-22 of the ’380
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`patent.
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`B. Anticipation
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`22.
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`I understand that a claim is invalid as anticipated if a single prior art
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`reference discloses each and every limitation of the claimed invention.
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`7
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`23.
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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 in the same order as claimed and would
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`inherently provide any claimed function.
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`24.
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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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`25.
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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
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`26.
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`I understand that obviousness is determined based on (1) the scope
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`and content of the prior art; (2) the differences between the claims and the prior art;
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`(3) the level of ordinary skill in the art; and (4) objective indicia of
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`nonobviousness.
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`27.
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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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`8
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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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`28.
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`I also understand that “objective indicia of nonobviousness” must be
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`considered, such as commercial success of the claimed invention, whether others
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`copied the invention, and whether others in the field praised the invention.
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`29.
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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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`III. SCOPE OF OPINIONS
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`30.
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`I have been asked only to provide my independent opinions and
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`analysis of the issues I specifically discuss in this declaration. I note that the
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`Petition (and the evidence it cites) appears to raise many other issues, but I have
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`not been asked to provide my opinions as to any of those other issues.
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`IV. PERSON OF ORDINARY SKILL IN THE ART
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`31.
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`I understand that the Petitioner and Drs. Brecker and Hillstead have
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`proposed a definition of a person of ordinary skill: “If a person of ordinary skill in
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`the art (“POSITA”) was a medical doctor, h/she would have had (a) a medical
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`degree; (b) completed a coronary intervention training program, and (c)
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`9
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`experience working as an interventional cardiologist. Alternatively, if a POSITA
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`was an engineer s/he would have had (a) an undergraduate degree in engineering,
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`such as mechanical or biomedical engineering; and (b) three years of experience
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`designing medical devices, including catheters or catheter-deployable devices.
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`Extensive experience and technical training might substitute for education, and
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`advanced degrees might substitute for experience. Additionally, a POSITA with a
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`medical degree may have access to a POSITA with an engineering degree, and a
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`POSITA with an engineering degree may have access to one with a medical
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`degree.” E.g., Petition at 12 (citing Ex. 1805, ¶ 27, Ex. 1842, ¶¶ 18-19). While I
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`do not necessarily agree with this proposed definition, my opinions below are
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`provided with respect to this definition of a POSITA.
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`32.
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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 provided by the Petitioner and
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`Drs. Brecker and Hillstead of a POSITA.
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`V. THE ‘380 PATENT
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`33.
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`I have reviewed the claims and specification of the ‘380 Patent. I
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`have also reviewed the prosecution history of the ‘380 patent.
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`34. The ’380 Patent includes three independent claims—claims 1, 12, and
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`25.
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`10
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`35.
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`I understand that the only independent claim that Medtronic’s Petition
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`challenges is independent claim 25. Claim 25 of the ‘380 patent recites:
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`25. A system comprising:
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`means for guiding an interventional device from a
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`location outside of a subject, through a main vessel, to a
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`location near an ostium of a branch vessel; and
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`means for receiving the interventional device from an
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`intermediate or distal portion of the means for guiding
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`the interventional device to the location near the ostium
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`of the branch vessel and guiding the interventional
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`device deeper into the branch vessel,
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`the means for receiving the interventional device and
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`guiding the interventional device deeper into the branch
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`vessel including, in a distal to proximal direction, a tip
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`portion, a reinforced portion, a side opening, and a
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`substantially rigid portion, and having a length such
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`that when the distal end of the tip portion is extended
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`distally of the distal end of the means for guiding the
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`interventional device to the location near the ostium of
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`the branch vessel, a portion of the proximal end of the
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`substantially rigid portion extends proximally of the
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`proximal end of the means for guiding the
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`interventional device to the location near the ostium of
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`the branch vessel,
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`wherein the tip portion, the reinforced portion, the side
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`opening, and the substantially rigid portion are
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`11
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`configured to be passed, at least in part, into a lumen of
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`the means for guiding the interventional device to the
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`location near the ostium of the branch vessel, and
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`the side opening and the substantially rigid portion are
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`configured to be more rigid along a length thereof than
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`the tip portion.
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`VI. MEDTRONIC’S REFERENCES
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`A. Kontos (Ex. 1809)
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`36. Kontos provides a “support assembly” used in fixed-wire (or “non-
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`over-the-wire”) balloon catheter exchanges and other uses that necessitate using a
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`narrow distal body with a funnel. Ex. 1809 at 1:9-16, 1:29-35, 2:25-26, 7:6-22,
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`10:22-26.
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`37. During an interventional cardiology procedure, it is not uncommon for
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`a physician to need to exchange balloon catheters. For example, a catheter
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`exchange may be needed where an initial balloon was used for dilation, but
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`dilation with a larger balloon was desired to improve the final result, where the
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`initially introduced balloon was too large to cross a lesion, or where pre-dilation
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`with a smaller balloon catheter is needed to allow delivery of a larger-profile stent
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`delivery catheter. When performing a catheter exchange, it is important to
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`maintain the initial pathway established, e.g., by a guidewire, to a lesion, as
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`crossing the lesion a second time can be “very arduous” or dangerous to the
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`patient. Ex. 1834 at 1:59-63. Fixed-wire balloon catheters have a “built in”
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`12
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`
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`guidewire for navigation and support. Consequently, when a fixed-wire catheter is
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`withdrawn from a vessel with a lesion, there is no guidewire or other structure left
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`to preserve the pathway back to the lesion. See id. at 2:2-5.
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`38. Kontos’s support assembly has a pushrod (insertion/manipulation wire
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`14) attached to a distal body 12 that has a tube 16 with a lumen 22:
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`39. Kontos’s body portion is relatively narrow in diameter—the lumen
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`preferably has an inner diameter of 0.045 inches. Id. at 4:48-52. Kontos explains
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`that such a size is large enough to permit passage of a deflated PTCA balloon. Id.
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`at 4:66-5:2. The outer diameter is preferably 0.055 inches in the central region of
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`tube 16, which expands to 0.065 inches in the base portion 18 where the wire
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`attaches to body 12. Id. at 4:48-58. Kontos’s preferred dimensions, including the
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`13
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`dimensions of the funnel, permit the Kontos device to be used within a 6 French
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`guide catheter.
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`40. At the distal end of the body, the marker band has an outer diameter
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`of 0.060, with the soft tip expanding the outer diameter even further. Id. at 4:48-
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`58, Fig. 1. The larger diameter of the distal and proximal ends (where the marker
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`band 30 and its covering material, the funnel, and the protrusion for mating with
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`the insertion wire 14 are located) limit the minimum inner diameter of the guide
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`catheter with which Kontos’s device can be used. Additionally, because Kontos’s
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`body has a larger diameter at both its proximal and distal ends, there is necessarily
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`a gap between the outer wall of the narrower central portion of Kontos’s body 12
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`and the inner wall of the guide catheter, as shown below:
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`Gaps between walls
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`Ex. 1809 at Fig. 6A (color and red annotation added). As a result of this design,
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`Kontos’s support catheter would not provide backup support during delivery of the
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`disclosed PTCA balloon catheter.
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`1.
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`The Kontos Device Differs from at Least the Tubular
`Structure Disclosed in the ‘380 Patent Specification
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`41. Kontos’s body portion is different from the “means for receiving . . .
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`14
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`and guiding” disclosed in the specification of the ‘380 patent, at least with respect
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`to the tubular structure. Unlike the uniform outer diameter tubular structure
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`disclosed by the ‘380 patent, Kontos’s body portion has multiple structures that
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`project outwardly from tube 16. See, e.g., Ex. 1809 at Figs. 1 and 6B. This is
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`apparent from Figure 1 from Kontos, below:
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`Marker band and
`soft tip
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`Funnel
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`Protrusion to receive wire 14
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`Ex. 1809 at Fig. 1. Kontos explains that the asymmetrical “conical opening of
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`lumen 22 at funnel portion 26 facilitates insertion of a PTCA catheter or the like
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`therethrough.” Ex. 1809 at 3:66-68; see also id. at 7:49-52. Kontos further
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`discloses that a PTCA catheter can be inserted into the body portion “because of
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`funnel portion 26.” Id. at 7:20-22 (emphasis added). Kontos also explains that the
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`asymmetric protrusion on the bottom of its structure is needed in order to “connect
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`[insertion] wire 14 to body 12,” and that the eccentricity of the connection
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`“provides leverage for facilitating manipulation of the body 12.” Id. at 4:25-38.
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`15
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`2.
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`The Kontos Device Is Not Equivalent to the Structure
`Disclosed in the ‘380 Patent Specification
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`42. The structure of Kontos is also not equivalent to the structure
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`disclosed in the specification of the ‘380 patent. Among other things, the tubular
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`portion of the structure disclosed in the ‘380 patent specification has a constant
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`outer diameter that, in conjunction with the lumen that is coaxial with the guide
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`catheter, allows for maximizing the cross-sectional size of the interior lumen,
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`thereby maintaining as much room as possible for receiving and guiding stent and
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`balloon catheters to a location deep inside coronary anatomy. See Ex. 1801 at
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`3:28-43 and 5:33-36. In contrast, the Kontos device has less “real estate” within its
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`body as a result of the funnel-shaped proximal portion of varying outer diameters,
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`as well as the presence of the protrusion associated with the pushrod 14. Ex. 1809
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`at Figs. 1-4 and 6B. This is apparent from Figures 2-4 of Kontos, shown below,
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`where the usable interior lumen is smaller given the presence of the funnel and
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`pushrod.
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`Id. at Figs. 2-4, 6:7 (describing the “outward flare” of funnel 26).
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`43. Further, the various diameter enlargements on the outer surface of
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`
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`16
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`
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`Kontos’s body portion (i.e. the funnel, protrusion for the insertion wire, and the
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`marker band and covering material) prevent the narrower central body portion
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`from being in close contact with the interior wall of the guide catheter along its
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`length. This can be seen in Kontos’s Figure 6A, below:
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`Gaps between walls
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`
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`Ex. 1809 at Fig. 6A (color and red annotation added). Because the exterior wall of
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`Kontos is not in close contact with the interior wall of the guide catheter, the
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`Kontos device does not provide increased back-up support when an interventional
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`cardiology device is inserted through the lumen of Kontos. Indeed, it is the close
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`contact between the exterior wall of a guide extension catheter like that described
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`in the ’380 patent and the interior wall of the guide catheter that creates the
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`reactive forces that result in increased backup support. See Ex. 1801 at 8:18-32.
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`44. The funnel-shaped Kontos device having varied outer diameters,
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`which does not provide backup support, is not equivalent to the structure disclosed
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`in the ‘380 patent specification.
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`17
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`B. Adams (Ex. 1835)
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`45. Adams is directed to an embolic protection device that uses a guide
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`seal – i.e., a braided tube covered with a sealing membrane. Ex. 1835 at [0011].
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`When the distal end of the Adams’s guide seal is extended distally of the guide
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`catheter’s distal end, it expands to stop blood flow down the vessel.
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`Id. at Fig. 2C. A distal protection element (such as a net) then is passed through
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`the guide seal, downstream of the lesion, to trap emboli.
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`
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`Id. at Fig. 2E.
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`46. Additionally, the Adams device does not assist in providing back-up
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`support; instead, Adams relies on the expansion of the guide seal to contact the
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`
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`18
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`
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`vessel wall to stay in place. Adams explains that “[i]n the case of an 8 French
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`guide catheter, the proximal section of the guide seal may have a diameter of 6
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`French, for example.” Id. at [0052]. Adams is simply an embolic protection
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`device. Indeed, one of skill in the art would recognize that it would be undesirable
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`to rely on the pressure and friction of the expanded guide seal against the blood
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`vessel to prevent the guide catheter from moving in response to forces exerted by
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`an advancing interventional cardiology device.
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`VII. A POSITA WOULD NOT BE MOTIVATED TO MODIFY KONTOS
`TO ARRIVE AT THE CLAIMED SIDE OPENING
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`47. A person of ordinary skill would not look to the angled opening on the
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`Adams guide seal to modify the proximal opening of Kontos’s body portion.
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`Those references are directed to different problems, and I am not aware of a reason
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`why one of ordinary skill would seek to combine them.
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`48. Kontos explains that the funnel portion 26 “facilitates insertion of a
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`PTCA catheter or the like therethrough.” Ex. 1809 at 3:67-68. Kontos’s funnel
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`reduces the space between the outer wall of Kontos’s device and the inner wall of
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`the guide catheter at the proximal end of Kontos’s device. Distal to Kontos’s
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`funnel, a gap is created by Kontos’s structure—specifically, the wider distal end
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`caused by the marker band 30 and its covering material, and the wider proximal
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`end caused by the protrusion necessary to facilitate attachment of the insertion wire
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`14. Removing Kontos’s funnel would expose this gap between the cut side of the
`
`19
`
`
`
`device and the wall of the guide catheter that could catch the coil tip of an
`
`advancing guidewire or fixed-wire device (i.e., the devices Kontos was designed to
`
`accommodate), or could catch a stent delivery catheter or other device that might
`
`be inserted through the guide catheter. This is apparent from the figure below,
`
`which shows Kontos modified as advocated by the Petition (red) inside a guide
`
`catheter (blue), and with the coil tip of an advancing guidewire or fixed-wire
`
`catheter (yellow) getting caught in the space between the cut portion of the funnel
`
`and the inner wall of the guide catheter:
`
`
`
`Catch point
`
`
`
`
`
`
`
`
`The figure above is based on Kontos’s Figure 6A with color, the Petition’s
`
`proposed modification, and an exemplary guidewire or guidewire tip of a fixed
`
`wire catheter (yellow) added.
`
`49. Further, other references taught away from replacing Kontos’s funnel
`
`with a side opening. For example, the Ressemann reference (Ex. 1808) relied on
`
`by Medtronic in the IPR2020-00129 petition, which challenges claims of the same
`
`‘380 patent, teaches that intravascular devices such as stent delivery catheters are
`
`20
`
`
`
`subject to “hanging-up or catching” on the proximal end of the side opening of its
`
`device, absent a specific “reverse bevel” structure that was provided in
`
`Ressemann’s design. Ex. 1808 at 25:20-29.
`
`50. Additionally, Kontos itself and the other contemporaneous art taught
`
`that when one had a device with a lumen that is significantly smaller in diameter
`
`than the inner diameter of the guide catheter—which diameter difference is
`
`necessitated by the nature of Kontos’s design—one should use a funnel-like
`
`structure, not a side opening. Ex. 1809 (Kontos) at 3:66-68, 7:20-22 (“Because of
`
`funnel portion 26, the [PTCA] catheter can negotiate the transition from guide
`
`catheter 38 into body 12.”), 7:49-52; Ex. 1834 (Adams ‘292) at 16:1-15 (“The first
`
`outer diameter 274 of the frusto-conical portion 270 of the proximal funnel 260
`
`coincides with the internal diameter of the guide catheter so that there is a close
`
`tolerance therebetween to facilitate the insertion of an angioplasty device through
`
`the guide catheter and then through the proximal end of the tube 255.”).
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`Ressemann, like Kontos and the other contemporaneous art, also taught that an
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`outward “flare” at the proximal opening (similar to Kontos’s existing funnel)
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`would “allow for easier passage of devices through the proximal end.” Ex. 1808 at
`
`7:40-44, Fig. 11A. In contrast to Ressemann’s side-opening embodiment,
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`Ressemann does not identify any concerns with hang-up or catching with respect
`
`to the “flare” or funnel embodiment.
`
`21
`
`
`
`51. The Petition identifies four purported motivations to combine Kontos
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`and Adams’s angled opening. Petition at 35-39. In my view, there are problems
`
`with all of them that are not addressed in the Petition or in the Declarations of
`
`Medtronic’s experts.
`
`52. The Petition first argues that using a side opening would have allowed
`
`for use of 6 French guide catheters that were preferred in the art in 2006 when the
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`‘380 priority application was filed. Petition at 35-37. As explained above,
`
`however, the preferred dimensions given in Kontos for the support catheter are
`
`already compatible with use in a 6 French guide catheter. Supra, ¶ 39. Thus, no
`
`modifications were necessary to address the more prevalent use of 6 French
`
`catheters in 2006. Moreover, the distal end of Kontos’s support body is essentially
`
`the same outer diameter as the proximal end, due to the presence of the marker
`
`band and soft tip around the outer circumference of the main body. Consequently,
`
`removal of Kontos’s funnel would not actually facilitate use of a smaller diameter
`
`guide catheter.
`
`53. The next alleged motivation identified in the Petition is to address a
`
`known problem that an interventional cardiology device “could snag or become
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`‘hung-up’” when entering Kontos’s support catheter. Petition at 37. But the
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`evidence relied on in the Petition does not indicate that this is a problem for
`
`designs that, like Kontos’s, employ a funnel at the proximal end of the body
`
`22
`
`
`
`portion. And as discussed above, the modification proposed in the Petition would
`
`likely increase the likelihood that an interventional cardiology device could snag
`
`or become hung-up, by creating a gap or catch point at the entry to the body
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`portion. Supra, ¶¶ 48-49.
`
`54. The third alleged motivation is that a POSITA would have been
`
`“motivated to add a proximal side opening” because “adding a side opening to the
`
`distal lumen of the child catheter reduces the amount of force that a physician must
`
`exert to advance the catheter through winding vasculature.” Petition at 38
`
`(emphasis added). This makes no sense to me. Modifying the shape of the distal
`
`end of a support catheter might have an effect on the force required to introduce
`
`the support catheter, because the distal end leads the way into the vasculature. But
`
`that would not lead a POSITA to conclude that modifying the shape of the
`
`proximal end of a support catheter like that of Kontos would have any effect on the
`
`force required to advance the support catheter into the vasculature.
`
`55. The fourth alleged motivation identified in the Petition is
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`“permitt[ing] smooth re-entry if the proximal end of the guide extension catheter
`
`was extended beyond the distal end of the GC.” Petition at 38. Facilitating re-
`
`entry of the proximal end into the guide catheter involves different considerations
`
`from the introduction of interventional devices into that proximal end. Moreover, I
`
`do not see that Medtronic’s expert has weighed any potential benefit in making re-
`
`23
`
`
`
`entry easier against the significant problems associated with removal of Kontos’s
`
`funnel I discussed above, and any potential benefit would not outweigh those
`
`problems.
`
`
`
`
`
`24
`
`
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`liwcuted on April 7, 2020.
`
`kéLf/fé \
`
`Peter T. Keith
`
`Page 26
`
`25
`25
`
`
`Teleflex Ex. 2042
`Medtronic v. Teleflex
`
`IPR2020-00131
`
`
`
`PETER T. KEITH
`50 N. Mississippi River Blvd.
`St. Paul, MN 55104
`c: 651-270-0794 e: pete_keith@hotmail.com
`
`
`SUMMARY:
`
` I
`
` am a seasoned innovator in medical device development with over 30 years of experience in a diverse range of
`medical specialties including cardiology, vascular surgery, otolaryngology, and orthopedics. I have founded several
`early stage companies, and consulted with numerous others. I have a passion for advancing technology in high
`impact areas of medicine for the benefit of patients and healthcare
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