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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`DECLARATION OF PETER KEITH REGARDING CONCEPTION AND
`REDUCTION TO PRACTICE SUBMITTED IN CONNECTION WITH
`PATENT OWNER’S RESPONSES
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`1
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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 Patent Owner, whom I will also refer to in this
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`declaration as “VSI,” to provide my expert opinions in this matter. I make this
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`Declaration in connection with Patent Owner’s Responses to Petitions filed in
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`response to the following IPR Petitions:
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`IPR No.
`IPR2020-01341
`IPR2020-01343
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`Patent No.
`8,142,413
`RE46,116
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` refer to the patents in this table collectively as “the GuideLiner patents.” If called
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` I
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`to testify, I could and would testify to the following facts and opinions.
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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 to this declaration 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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`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. Many of my consulting clients and/or the products they developed
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`with my assistance were subsequently acquired by large medical technology
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`companies, including St. Jude Medical/Abbott, Johnson & Johnson, Teleflex,
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`Edwards Lifesciences and LivaNova. A number of the products I have consulted
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`on have been in the field of interventional cardiology, particularly catheters.
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`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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`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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`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. Many of
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`these patents concern catheters.
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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 analysis on behalf of Teleflex in the case of QXMédical, LLC v.
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`Vascular Solutions LLC, et al., No. 0:17-cv-01969 (D. Minn.) (the QXM case).
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`U.S. Patent Nos. 8,142,413 and RE46,116 are in the same family as the patents that
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`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 prior, related-IPRs (IPR2020-00126, IPR2020-00127, IPR2020-00128,
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`IPR2020-00129, IPR2020-00130, IPR2020-00132, IPR2020-00134, IPR2020-
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`00135, IPR2020-00136, IPR2020-00137, and IPR2020-00138), namely, U.S.
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`Patent Nos.: 8,048,032, RE45,380, RE45,760, RE45,776, and RE47,379.
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`Additionally, I have provided expert opinions concerning these same five, related
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`patents on behalf of Teleflex in the case of Vascular Solutions LLC, et al. v.
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`Medtronic, Inc., et al., No. 19-cv-01760 (D. Minn.). Those opinions were
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`provided in connection with Teleflex’s Motion for Preliminary Injunction.
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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 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 in 2005 and
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`2006.
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`10.
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`In this declaration I discuss various exhibits that I understand have
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`already been submitted in this proceeding.
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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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`12.
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`I have been asked to provide my independent opinions and analysis of
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`the issues I specifically discuss in this declaration. I note that the Petitions (and the
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`evidence they cite) appear to raise many other issues, but I have not been asked to
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`provide my opinions as to any of those other issues in this declaration.
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`13.
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`I have reviewed all of the IPR petitions filed by Medtronic on the
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`GuideLiner patents, as well as the accompanying declarations of Dr. Hillstead and
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`Dr. Brecker filed in support of the IPR petitions.
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`14.
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`I have also reviewed numerous additional materials that I understand
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`have been submitted in these IPR proceedings, including: the Declaration of
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`Howard Root Submitted in Connection with Patent Owner’s Responses (Exhibit
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`2118) and the exhibits cited therein; and the Declaration of Gregg Sutton (Exhibit
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`2119) and the exhibit cited therein.
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`15.
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`I understand that Petitioner asserts U.S. Patent No. 7,736,355 (“Itou”)
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`qualifies as prior art to the GuideLiner patents under 35 U.S.C. § 102(e) based on
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`its filing date of September 23, 2005. Itou is directed to a suction catheter and thus
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`is not designed to facilitate the delivery of stents or other interventional cardiology
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`devices into cardiac vasculature.
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`16.
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`I understand that Itou would not be prior art if the VSI inventors
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`either (a) reduced the claimed invention to practice prior to September 23, 2005, or
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`(b) conceived of the claimed invention prior to September 23, 2005 and exercised
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`reasonable diligence between September 23, 2005 and a later actual or constructive
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`reduction to practice.
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`17.
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`I understand that reduction to practice occurs when the inventor or
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`those working on the inventor’s behalf: (a) constructs an embodiment or performs
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`a process that meets the claimed invention; and (b) demonstrates that the invention
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`is suitable for its intended purpose. I further understand that reduction to practice
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`does not require the invention, when tested, be in a commercially satisfactory stage
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`of development.
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`18.
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`I understand that the character of the invention and the problem it
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`solves determines whether testing is required, and that the sufficiency of testing is
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`determined using a common sense approach. Actual reduction to practice does not
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`require commercial perfection, or absolute replication of the circumstances of the
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`invention’s ultimate use; thus, simulation is sufficient where testing is needed.
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`19. The purpose of the guide extension catheters described and claimed in
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`the patents-in-suit is to facilitate delivery of interventional cardiology devices,
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`including stents and balloon catheters, into challenging coronary anatomy.
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`20.
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`It is my opinion that actual reduction to practice of the GuideLiner
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`invention would have required little if any testing. For example, because mother-
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`in-child procedures already were understood to provide back-up support, testing
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`would not have been necessary to understand that a rapid exchange GuideLiner
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`prototype would work for that purpose. To the extent any other testing were
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`necessary to understand, for example, that a prototype GuideLiner could receive
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`and deliver interventional cardiology devices like stents or balloon catheters,
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`qualitative testing would have been sufficient. It would not be necessary to test the
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`device in a human or animal.
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`21.
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`It was in 2005, and remains today, standard practice in the medical
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`device industry to test new designs on bench models that simulate the native
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`environment in which they would be used to determine whether those designs
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`would work for their intended purpose. This was particularly true in 2005, and is
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`still today, for catheter related designs in the interventional cardiology space.
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`Indeed, this was the same process we followed during my time at Scimed (then
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`later Boston Scientific) and elsewhere to determine whether a catheter related
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`design would work for its intended purpose. For example, an invention shown in
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`U.S. Patent No. 8,267,872, which I am an inventor on, describes a guidewire with a
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`unique core wire tip construction. It was designed to improve the steerability
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`characteristics of guidewires, such as coronary guidewires used in interventional
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`cardiology procedures. The improved steerability was demonstrated with early
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`prototypes tested in a bench model. Qualitative testing showing that the novel
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`guidewire had smooth rotation of the tip was enough to demonstrate to me as an
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`inventor that the invention would work for its intended purpose. It was certainly
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`not ready for commercialization at this point, but the invention was shown to work
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`for its intended purpose.
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`22. Similarly, it is my opinion that, to the extent testing of a GuideLiner
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`prototype were necessary at all, qualitative testing of a prototype would be more
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`than sufficient to reduce the invention to practice if the testing showed that the
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`prototype (a) could be delivered through a guide catheter so that the distal end of
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`the tubular portion extended beyond the distal end of the guide catheter while
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`being tracked over a winding path; and then (b) allowed a stent delivery catheter or
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`balloon catheter to pass into the tubular portion and out the far end of the tubular
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`portion while located within the guide catheter.
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`23.
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`It is further my opinion that testing a prototype GuideLiner device in a
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`bench model that simulates the native environment would be sufficient to show
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`that the device works for its intended purpose. Such a test would be consistent
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`with industry practice in 2005 (and even still today) to demonstrate that cardiac
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`catheter devices work for their intended purpose.
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`24.
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`I note that in-vivo testing of a device in a human or animal is not
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`required in all cases even to obtain FDA clearance to sell that device in the United
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`States. This is dependent on the nature of the technology and the approval process.
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`25.
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`I also note and understand that there is a difference between reducing
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`an invention to practice (i.e., showing that it will work for its intended purpose)
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`and refining a design such that the product can be made commercially in a
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`sufficiently durable and profitable way. It is not uncommon for medical device
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`products, and in particular catheter-related designs in the interventional cardiology
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`space, to take many years from the point of proving that a design will work for its
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`intended purpose to the point of having a commercially viable product ready for
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`FDA approval.
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`26. The fact that the GuideLiner device was not sold commercially until
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`2009 is not indicative of, and does not suggest that, the invention of the patents-in-
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`suit were not reduced to practice years earlier.
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`27. Similarly, the fact that further engineering work was performed after
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`August and September 2005 to develop a version of the GuideLiner that was
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`commercially viable is not indicative of, and does not suggest that the invention of
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`the patents-in-suit were not reduced to practice before then.
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`28.
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`I have reviewed the Declaration of Howard Root Submitted in
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`Connection with Patent Owner’s Responses (Exhibit 2118) and the evidence cited
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`therein, including Appendices A-B, comparing claims of the GuideLiner patents
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`with the evidence of the prototypes that Mr. Root explains VSI built and tested
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`prior to September 2005. It is my opinion that the April and July 2005 GuideLiner
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`prototypes met the structural limitations of the GuideLiner patent claims as stated
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`in Appendices A-B of Mr. Root’s Declaration. Furthermore, based on the evidence
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`I have reviewed, including the Declaration of Howard Root and the evidence
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`submitted therewith, I understand that Mr. Root and/or others at VSI tested the
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`April and Jul} protot} pes and understood them to \mrk for their intended purpose.
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`Based on m) rc\'ie\\ ol‘these materials I further understand that the methods of the
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`Guidel .incr patent claims as stated in Appendices A-B ot'Mr. Root‘s Declaration
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`\\ ere a natural use for the structures disclosed in the April and July 2005
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`prototypes.
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`I declare under the penalty ot‘perjur} that the foregoing is true and correct.
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`Executed on May E. 202]. in Ramsey County. Minnesota.
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`Peter Keith
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`H
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`Page 11
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`Teleflex Ex. 2123
`Medtronic v. Teleflex
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`PETER T. KEITH
`50 N. Mississippi River Blvd.
`St. Paul, MN 55104
`c: 651-270-0794 e: pete_keith@hotmail.com
`
`
`SUMMARY:
`
` I
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` 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 professionals, and I enjoy partnering with other
`innovators who share this passion.
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`EXPERIENCE:
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`Technical Consulting—Peter T Keith Consulting, LLC
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`1997 – present
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`2006 – 2014
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`2012 – 2015
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`2009 – 2013
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`2005 – 2006
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`2003 – 2011
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`2000 – 2005
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`Consulting for early stage medical device technology companies in areas of product
`design, intellectual property development.
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`Selected Clients: Amphora Medical, Caisson Interventional (LivaNova), Altura,
`Velocimed (St. Jude), CVRx, Myocor, Coaxia, eV3 (Medtronic/Covidien), ProtoStar,
`TERAMed (J&J).
`
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`Entrepreneurial Ventures
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`Entellus Medical (ENTL), Plymouth, MN. Development and commercialization of
`devices for treatment of Chronic Sinusitis. IPO January 2015. Stryker acquisition 2018.
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`Co-founder, Director, Vice President R&D, Chief Technical Officer. Executive
`management responsibility for overall product development of FinESS™ and XprESS™
`sinusitis treatment technologies, leadership of product development group, employee
`hiring, intellectual property, process development, and BoD responsibilities, long term
`technical advising.
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`CoreMetrics, Minneapolis, MN. Development of cardiology products. Co-founder.
`Responsible for device innovation, product development, and intellectual property.
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`Tarsus Medical, Sunnyvale, CA. Venture backed developer of extremities orthopedics.
`Co-founder, Technical Advisor. Technology Sold.
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`Incubex, St. Cloud, MN. Development cardiovascular products. Co-founder and CTO.
`Responsible for device innovation, product development, and intellectual property.
`Technology sold.
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`Aetherworks, White Bear Lake, MN. Development of devices for cardiovascular diseases
`and smoking cessation. Co-founder. Responsible for device innovation, product
`development. Technology sold.
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`Spinalabs, White Bear Lake, MN. Development of devices for spinal disorders. Co-
`founder. Responsible for device innovation, product development. Technology sold.
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`2003
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`2005 – 2007
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`2008
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`2017-present
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`1985 – 1996
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`PATENTS:
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`EDUCATION:
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`REFERENCES:
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`Patent Litigation Expert Witness
`
`Grayzel v. BSC (01-CV-3844 (KSH))—Case involving rigid members in a dilation
`balloon. Expert for Defendants. Case settled prior to trial.
`
`BSC v. Cordis (C 02-0790 SI) – Case involving angioplasty catheter extrusion technology.
`Expert for Plaintiffs, testified at trial.
`
`SciCo Tec GMBH v. BSC (9:07-cv-76 (RHC)) – Case involving “rapid exchange”
`angioplasty catheter designs. Expert for Defendants. Case settled prior to trial.
`
`QXMédical, LLC v. Vascular Solutions LLC, et al. (0:17-cv-01969) – Case
`involving “guide extension catheters”. Expert for Vascular Solutions. Ongoing.
`
`
`R&D Engineering
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`Boston Scientific/SCIMED, Minneapolis, MN. Development and commercialization of
`Interventional Cardiology products. Several positions starting from Engineering Intern to
`Director of R&D. Key accomplishments included design, development and project team
`leadership on ACE® and Expess® market leading angioplasty catheters; IP development
`and management; product strategy; and growing and leading a large R&D organization.
`
`Named inventor on over 140 issued U.S. patents plus additional corresponding foreign
`patents. Numerous additional U.S. and foreign patents are still pending.
`
`Bachelor of Science in Mechanical Engineering
`University of Minnesota, Minneapolis, MN
`June 1987, with High Distinction, GPA 3.9
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`Available upon request.
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`