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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 HOWARD ROOT SUBMITTED IN CONNECTION
`WITH PATENT OWNER’S RESPONSES
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`1
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`I, Howard Root, hereby declare and state as follows:
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`1.
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`I make this Declaration in connection with Patent Owner’s Responses
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`to Petitions filed in response to the following IPR Petitions:
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`IPR No.
`IPR2020-01341
`IPR2020-01342
`IPR2020-01343
`IPR2020-01344
`
`Patent No.
`8,142,413
`8,142,413
`RE 46,116
`RE 46,116
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` refer to the patents in this table collectively as “the GuideLiner patents,” as they
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` I
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`are the patents that were obtained for and protect the GuideLiner® guide extension
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`catheter, which was the most successful product introduced by Vascular Solutions,
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`Inc. (“VSI”), a company that I founded and was the Chief Executive Officer of for
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`20 years. I am also a named inventor on the GuideLiner patents.
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`2.
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` I was originally trained as a lawyer and worked in private practice
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`from 1985-1990. In 1990, I left private practice to serve as General Counsel at
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`ATS Medical, Inc., a medical device company, which has since been acquired by
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`Medtronic, Inc. I left ATS Medical in 1996 and founded VSI in 1997. I acted as
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`the CEO of VSI from 1997 until 2017. In 2017, VSI was acquired by Teleflex
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`Incorporated, the current owner of the GuideLiner patents (through a subsidiary
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`entity).
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`2
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`3.
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`I am aware that Teleflex has filed suit against Medtronic, Inc. and
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`Medtronic Vascular, Inc. (“Medtronic”) for infringement of the GuideLiner
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`patents. I have been retained as a consultant on behalf of Teleflex in connection
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`with that lawsuit and the present IPR Petitions. However, I have no ongoing
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`involvement in the Teleflex business and I have no financial interest in the
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`outcome of the litigation.
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`4.
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` Throughout my time at VSI, I was personally active in, among other
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`things, product conception and development, legal and marketing efforts, and
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`sales. I was actively involved with the GuideLiner project and product
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`embodiments at the time the inventions of the GuideLiner patents were conceived
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`and reduced to practice, and at the time the applications that ultimately resulted in
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`the patents-in-suit were filed. GuideLiner created the market for rapid exchange
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`guide extension catheters, but that success was not due to VSI’s size or its pre-
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`existing market position. At the time of the GuideLiner launch, VSI was a
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`relatively small medical device company that had developed, among other
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`products, a number of specialty catheters used in interventional cardiology
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`procedures—but it had no market dominating products. I and others have said
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`numerous times that GuideLiner is what put VSI on the map. GuideLiner was
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`launched at the end of 2009, and by 2013, GuideLiner had become the company’s
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`top-selling product. By the first quarter of 2014, GuideLiner had been used in
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`3
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`virtually all of the over 2,000 interventional cardiac catheterization labs across the
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`United States. GuideLiner’s tremendous success and its ubiquity in the market led
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`many customers to refer to VSI as “the GuideLiner company.”
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`Conception of GuideLiner
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`5.
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`I attended the annual Transcatheter Cardiovascular Therapeutics
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`(“TCT”) conference in 2004, which took place in Washington, D.C. from
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`September 27 to October 1. By that time I had recognized issues physicians were
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`experiencing with guide catheter backout in complex interventional coronary
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`procedures. I realized that there was a need for a solution in complex
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`interventional coronary procedures that provided better guide positioning, device
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`delivery, and procedural conveniences than what then existed.
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`6.
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`Around the time of the 2004 TCT conference, I conceived of the idea
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`for a guide extension catheter that would provide improved back-up support with
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`rapid exchange delivery, which would offer far more convenience than other
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`options available at the time. Sometime after the TCT conference, but before
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`2005, my co-inventors and I met to discuss particular ideas for how to make such a
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`device.
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`7.
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`At a high level, the device we developed was a guide extension
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`catheter to be used within a one French size larger guide catheter. The guide
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`extension catheter included a substantially rigid proximal portion comprising a
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`4
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`“rail” structure and a tubular portion with a lumen distal of the proximal portion,
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`which together were longer than the overall length of a standard guide catheter.
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`The distal tube portion was reinforced with a braid or coil, and it could have a
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`highly flexible atraumatic “bumper tip.” In use, a standard guide catheter would be
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`inserted first into the vasculature until the distal end of the guide catheter was
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`located in the ostium of a cardiac artery within the heart. Our guide extension
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`catheter would then be inserted through the guide catheter until the tubular
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`portion’s distal end extended past the distal end of the guide catheter and into the
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`cardiac artery. An interventional cardiology device, such as a balloon catheter or a
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`stent, would then be inserted through the guide catheter (running alongside the rail
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`of our guide extension catheter), into the proximal end of the tubular portion of our
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`guide extension catheter, and ultimately out of the distal end of the tubular portion
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`and into the cardiac artery.
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`8. We also contemplated that the guide extension catheter would
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`optionally be used together with a dilator. The dilator would be inserted into the
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`tubular portion outside the body and would further assist with guiding the
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`extension catheter past the end of the guide catheter and into the cardiac artery.
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`The dilator would then be removed from the body prior to insertion of an
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`interventional cardiology device such as a stent or balloon catheter.
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`5
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`9.
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`Exhibit 2253 is a true and correct copy of pages from co-inventor
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`Gregg Sutton’s laboratory notebook. Conception of the inventions claimed in the
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`GuideLiner patents by the beginning of 2005 is reflected by an entry in Mr.
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`Sutton’s lab notebook signed and dated January 4, 2005. This lab notebook entry
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`is called “Guide-Liner Device” (the hyphen was later dropped). The recorded
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`device was described as providing additional back-up support for the delivery of
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`interventional cardiology devices. It was further described as allowing for rapid
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`exchange convenience and fitting in a standard 6 French guide catheter and being
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`one French size smaller than the standard guide catheter. The notebook entry also
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`illustrates and describes a cut away (partial-round), stainless steel proximal section,
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`joined to a softer, distal tube section. The distal tube section is at least partially
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`reinforced (e.g., by a coil and/or braid), has a radiopaque marker and a bumper tip,
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`and has an outer diameter of 0.065” and an inner diameter of 0.054”. The overall
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`device length is stated as being 105-115 cm, which is longer than a standard 100
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`cm guide catheter. One of the drawings appearing in this lab notebook entry is
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`nearly identical to Figure 2 of the GuideLiner patents:
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`6
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`10. Mr. Sutton’s lab notebook also contained a sketch showing how the
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`GuideLiner would be used:
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`7
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`11. By early February 2005, I realized that the device we had conceived
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`would have substantial market potential. Exhibit 2254 is a true and correct copy
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`of a February 4, 2005 memo regarding Market Feasibility for the GuideLiner
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`catheters. (See also Exhibit 2127, which is a public, redacted version of Exhibit
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`2254.) Such memos were drafted only after I had developed high confidence that a
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`concept would work, at which time other people in the company beyond the
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`inventors, such as regulatory personnel and engineers, would be included in the
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`project to help bring the new product to market. As this memo reflects, by
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`February 4, 2005, I (and others) had recognized a substantial market potential
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`specifically for a rapid exchange GuideLiner device. In the memo I also described
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`the rapid exchange GuideLiner as we had conceived it: the rapid exchange
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`GuideLiner would be delivered inside a standard guide catheter for use in
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`interventional cardiology procedures; it had a short distal tube segment to allow for
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`rapid exchange delivery; it was inserted through the existing hemostatic valve; and
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`it was about one catheter size (one French size) smaller than the guide catheter it
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`was used with. The memo also notes some evaluations that were performed to
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`determine the space necessary between the outer diameter of the GuideLiner’s
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`distal tubing and the inner diameter of the guide catheter it was used with to allow
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`delivery.
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`8
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`12. Exhibit 2255 is a true and correct copy of hand-written notes made by
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`me on February 7, 2005. Conception of the inventions claimed in the GuideLiner
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`patents is further reflected by these notes, which also show features of the rapid
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`exchange GuideLiner device, including a depiction of a side opening section,
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`transitioning from a partial-round, proximal portion, to a full round portion
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`connected to a distal tube section. My February 7, 2005 notes also describe the
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`dimensions of three sizes of GuideLiner, each being one French size smaller than
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`an associated guide catheter. My drawings on page 1 of Exhibit 2255 are similar
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`to the drawings appearing as Figure 1 of the GuideLiner patents:
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`9
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`13. An important feature of GuideLiner is a “side opening” at the
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`transition between the proximal rail structure and the distal tubular portion that
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`facilitates entry of interventional cardiology devices into the proximal end of the
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`tubular portion. This feature is reflected in the crude shading between the rail
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`structure and the tubular portion shown in the sketch above from my February 7,
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`2005 notes.
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`14. Another side opening concept is shown on page 3 of Exhibit 2255:
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`This sketch shows a side opening structure that is cut-away in several segments
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`including, from left (distal) to right (proximal): a full round portion; a first angled
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`transition portion; a first partial round portion; a second angled transition portion;
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`and a second partial round portion. Pages 2-3 of Exhibit 2255 are undated, but
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`they were made contemporaneously with my notes on page 1 of Exhibit 2255.
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`Reduction to Practice
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`15. Between January and August of 2005, prototypes of the rapid
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`exchange GuideLiner were built and tested. I recall Mr. Sutton and Mr. Welch
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`(another of the named inventors) leading the efforts to make the first such
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`prototype.
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`10
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`16. During the January to March 2005 time period, one of VSI’s
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`machinists named Steve Erb, worked with Mr. Sutton and/or Mr. Welch to
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`mechanically cut stainless steel hypotubes into the proximal portion of a rapid
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`exchange GuideLiner prototype. At least some of these initial prototypes were
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`made of a machined-down hypotube with a profile that was full circumference at
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`the distal end and a roughly half-round profile at the proximal end. The
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`mechanically cut stainless steel hypotube was then combined with a polymer distal
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`section to create the first prototypes of the rapid exchange GuideLiner. Even these
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`first prototypes made in-house were subjected to testing. I very quickly
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`understood, even based on just these earliest prototypes that the rapid exchange
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`GuideLiner would work and could be a commercially viable product.
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`17. We already knew that the GuideLiner would provide additional
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`backup support for delivering interventional coronary devices into the distal
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`anatomy because the over-the wire version of the concept had already been shown
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`by others to work for that purpose. At that time, VSI was a lean company with
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`active management focused on product development; therefore, we did not see the
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`need to, and we did not, create formal test protocols and reports to prove that the
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`initial GuideLiner concept worked during its design development phase. Instead,
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`what we did was perform confirmatory testing in a bench-top, coronary model that
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`simulated the native anatomy and environment for the deployment of the device
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`11
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`and the passage of interventional cardiology devices through it. Some of our
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`testing was performed in a two-dimensional anatomical model, while other testing
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`was performed in a three-dimensional anatomical model. Some of our testing
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`involved submerging the anatomical model into a water bath, and sometimes our
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`tests were performed dry. An example of such a two-dimensional coronary model
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`is shown in the following photographs from a July 2005 PowerPoint presentation,
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`discussed further below:
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`(Exhibit 2018, 2129.) Such coronary models were commonly used by VSI and
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`other medical device companies to test interventional cardiology catheters and
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`devices and to determine that they would serve their purpose inside a human heart.
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`We already had such coronary models at VSI at the time we began to build and test
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`GuideLiner prototypes.
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`18. Testing of the GuideLiner prototypes consisted of simulating a
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`procedure in which the GuideLiner would be used, including inserting a guidewire
`12
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`and a standard guide catheter over the guidewire into the coronary model and
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`positioning the distal end of the guide catheter at the ostium of a simulated branch
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`artery, attaching a hemostasis valve on the back (proximal end) of the guide
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`catheter, advancing the GuideLiner prototype through the hemostatic valve, which
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`is sometimes referred to as a Y-adapter, when in the open/non-sealing position into
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`the guide catheter until the distal end of the prototype extended beyond the distal
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`end of the standard guide catheter, and then delivering a stent or balloon catheter
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`into the guide catheter by way of the hemostatic valve, alongside the proximal rail
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`structure of the GuideLiner prototype, into and through the tubular portion of the
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`GuideLiner prototype and out the distal end of the GuideLiner prototype. Part of
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`the simulation involved sealing the hemostasis valve around a portion of the
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`proximal rail structure of the prototype GuideLiner after it had been inserted into
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`the guide catheter. We also observed the forces involved in navigating the
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`GuideLiner prototype through such a model, including when manipulating the
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`proximal rail portion of each GuideLiner prototype to advance the prototype
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`(including its side opening and tubular portion) through the lumen of the guide
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`catheter, and we performed pull tests to assess the durability of the prototype.
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`And, after observing how the GuideLiner prototypes operated as they were
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`navigated through the heart models, we then withdrew the prototypes from those
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`heart models.
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`13
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`19. Such testing, including testing the rapid exchange GuideLiner
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`prototypes in a bench-top model such as this, was sufficient to determine that the
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`concept would work for its intended purpose – namely that a rapid exchange guide
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`extension catheter could deliver interventional cardiology devices, such as a stent
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`or balloon catheter, alongside the rail segment, into the side opening and distal
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`tubular portion, and then out the distal end of the distal tubular portion and into
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`challenging coronary anatomy. Indeed, the same types of heart models that we
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`used to confirm the GuideLiner would work for its intended purpose in 2005 were
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`later used to train salespeople and physicians on how to use the GuideLiner device.
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`20. Although we knew the GuideLiner would work for its intended
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`purpose from the earliest prototypes in 2005, we continued to refine the design to
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`optimize performance, manufacturability and cost. These considerations drove us
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`to consider a number of different options for materials, processes and
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`specifications before we commercialized the product. We ultimately were able to
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`bring costs down to where they needed to be for commercialization with various
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`refinements, such as changing from a cut-down hypotube, which is very expensive
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`to manufacture, to the pushwire design that is seen in the GuideLiner today. Had
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`we not already determined that the GuideLiner would work for its intended
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`purpose, I would not have allowed the company to spend the substantial additional
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`time and resources that it took to bring this product to the commercial market.
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`14
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`21. Even after we launched GuideLiner V1 following FDA approval, we
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`continued to improve certain aspects of the product, such as the bond between the
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`proximal and distal portions and the geometry of the side opening through V2 and
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`V3, the latter of which is on the market today. Iterative improvements are
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`common in the medical device industry with the benefit of feedback from the
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`market as the product becomes more widely used and as technology advances.
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`22. The original idea for GuideLiner was a rapid exchange guide
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`extension catheter, as confirmed in the earliest drawings of GuideLiner, for
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`example, in Mr. Sutton’s lab notebook, my early 2005 drawings, and my February
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`4, 2005 Market Feasibility memo. (Exhibits 2253-2255.) Sometime between
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`February and June of 2005, a decision was made to concurrently pursue
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`development of an over-the-wire (“OTW”) version of GuideLiner. The OTW
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`GuideLiner was not part of the inventions of the GuideLiner patents, but rather was
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`akin to the prior art “mother-in-child” design that is discussed in the background of
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`the GuideLiner patents (see, e.g., the ’032 patent, col. 2:17-44). Between February
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`and the end of August 2005, we prototyped and tested both OTW and rapid
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`exchange versions of GuideLiner. Some of the documents discussed herein relate
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`to both the OTW and rapid exchange versions of GuideLiner, but many of them
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`relate only to the rapid exchange version that is the subject of the GuideLiner
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`patents. The OTW version of GuideLiner was pursued because it was believed at
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`15
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`the time that it could be brought to market quicker with less regulatory clearance
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`challenges than the rapid exchange version. While development work on an OTW
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`version of GuideLiner was performed in 2005 and early 2006 at VSI, development
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`of the rapid exchange GuideLiner remained the development priority and regular
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`work continued on its commercial development as it was believed to be a
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`completely new product with a significant unique market potential.
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`23. Teleflex no longer has many development documents from the 2005
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`time frame. For example, a number of engineering drawings were created for the
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`rapid exchange GuideLiner product between February and the end of August of
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`2005, but VSI did not maintain those drawings. The only reason that we were able
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`to locate the engineering drawings that are discussed in the declaration (see
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`Exhibits 2019, 2022, 2089, 2092, 2113, and 2114) is because they were sent to
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`VSI’s vendors to facilitate ordering components or to VSI’s patent prosecution law
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`firm to facilitate preparation of a patent application, and the vendors and/or law
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`firm maintained them in their files.
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`24. VSI did maintain some records relating to the purchase of components
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`for the GuideLiner prototyping and development, including invoices. Exhibit
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`2256 is a true and correct copy of a February 11, 2005 to June 30, 2006 spend
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`report relating to the GuideLiner development. This report confirms that
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`significant expenditures were made on the development of GuideLiner throughout
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`16
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`2005 and 2006. This spreadsheet does not capture all of the expenditures on
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`GuideLiner; for example, it does not capture internal work performed at VSI using
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`existing materials that VSI already had in its inventory.
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`25. The entries on Exhibit 2256 are charged under two different project
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`names. Generally, the entries before May 2005 are charged to “New Modalities.”
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`This is the account that we used for early stage work on new ideas before a project
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`account was created. In May of 2005, we opened an account specific to the
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`“Guideliner project,” indicating that development had advanced to the point that
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`we were confident we would proceed toward commercialization.
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`26. As discussed above with respect to the early prototypes made in-
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`house, an early plan for the substantially rigid proximal portion of the rapid
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`exchange GuideLiner was to use a “cut-down hypotube,” i.e., a round metal tube
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`that was full circumference at one end but was cutaway along the majority of its
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`length. Exhibit 2110 is a true and correct copy of an invoice showing delivery of
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`stock stainless steel hypotubing by Microgroup to VSI on January 14, 2005.
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`Exhibits 2257 and 2007 are true and correct copies of invoices showing delivery
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`of special stainless steel hypotubing by Microgroup to VSI on January 14,
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`February 8, and March 4, 2005. These invoices are for metal hypotubing that was
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`purchased by the foot, and thus were likely used for the earliest evaluations of the
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`rapid exchange GuideLiner concept.
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`17
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`27. From the earliest stages of the project, the plan was to combine the
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`substantially rigid proximal portion of the rapid exchange GuideLiner with a distal
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`polymer tubular portion that would be at least partially reinforced with coil or
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`braid. For the very earliest prototypes made in-house in January and February
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`2005, this distal tubular portion was sometimes made out of a portion of a standard
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`guide catheter that was cut to the appropriate length. For subsequent prototypes
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`we designed distal tubular portions specific to the rapid exchange GuideLiner.
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`28. Exhibit 2089 is a copy of an invoice, packing list, certificate of
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`conformance, sales order acknowledgement, quotation, purchase order, and
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`engineering drawing obtained from the files of Medical Engineering & Design,
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`which was VSI’s supplier for the distal tubular portion of the rapid exchange
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`GuideLiner prototypes at the time. The engineering drawing shown in Exhibit
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`2089 shows that it was drawn on February 10, 2005 by Jim Kauphusman, who was
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`an engineer at VSI working on the GuideLiner project at the time and left later that
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`year and I understand is now and has been working for Boston Scientific, a
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`competitor to VSI/Teleflex, for a number of years. Among other things, the
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`drawing and quote in Exhibit 2089 indicate that the tubular portion that was drawn
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`and ordered from Medical Engineering & Design included a PTFE liner, three
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`sections of different Pebax, reinforcing braid, a soft tip where braid is excluded
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`from the distal-most section of Pebax, and a platinum-iridium alloy marker band.
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`18
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`The drawing and quote also indicate that the proximal end of the tubular portion
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`should be counter bored, which would facilitate attachment to a cut-down
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`hypotube forming the proximal portion of the rapid exchange GuideLiner. The
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`11.8” length of the tubular portion shown in the quotation and drawing also
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`demonstrates it could only have been for the rapid exchange version of
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`GuideLiner, as any tubular portion for an over-the-wire version would have been
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`much longer. The purchase order of Exhibit 2089 indicates that 20 such distal
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`tubular portions were ordered from Medical Engineering & Design on February
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`17, 2005 and were delivered to VSI on or about April 5, 2005. Full featured tubes
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`like in Exhibit 2089 were only for rapid exchange GuideLiner prototypes and were
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`not used for the OTW version of GuideLiner. An annotated version of the drawing
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`in Exhibit 2089 is below:
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`19
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`Three Reinforced Pebax Portions
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`Proximal End
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`20
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`Soft Tip
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`Distal End
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`Pebax
`Braid
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`PTFE
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`29. Exhibit 2008 is a true and correct copy of invoices and a
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`corresponding payment check for GuideLiner dilators and shafts purchased from
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`the polymer extrusion company Medical Profiles & Engineering. The invoices are
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`dated February 24 and February 28, 2005, and indicate that the polymer dilators
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`and shafts purchased were white. This is consistent with my recollection that an
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`early prototype used white polymer for the dilator, while blue polymer was used
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`for the distal portion of the rapid exchange GuideLiner (and the entire length of the
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`OTW GuideLiner), with the exception of the bumper tip, which was sometimes
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`was yellow.
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`30. Exhibit 2009 is a true and correct copy of an invoice, packing slip and
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`email relating to the purchase of 11 hypotubes from Microgroup that were shipped
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`to VSI on or about March 10, 2005. The documents indicate that the order was
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`placed by Jeff Welch, a VSI engineer who is a named inventor on the GuideLiner
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`patents and who was involved in the early prototyping work. This invoice shows
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`the hypotubes were purchased by individual pieces (11 total) rather than by the
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`21
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`foot, and shows engineering charges indicating that Microgroup customized the
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`hypotubes for VSI’s use.
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`31. Exhibit 2090 is a true and correct copy of invoices and corresponding
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`payment check relating to the purchase of different sized forming tips from
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`Farlow’s Scientific Glassblowing Inc. The invoices are dated March 15, 2005.
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`Forming tips like this would have been used for forming the distal tip of a
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`GuideLiner prototype, including reforming a distal tubular portion purchased from
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`Medical Engineering & Design like that shown in Exhibit 2089.
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`32. Exhibit 2091 is a true and correct copy of an invoice, packing slip and
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`corresponding payment check relating to the purchase of 300 feet of stainless steel
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`hypotube from Microgroup that were shipped to VSI on or about March 18, 2005.
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`This stainless steel hypotube would have been used to make proximal rigid
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`portions of rapid exchange GuideLiner prototypes.
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`33. Exhibit 2010 is a true and correct copy of an invoice and packing slip
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`relating to the machining of 8 “Guideliner hypotube parts” from Mountain
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`Machine, Inc. that were shipped to VSI on or about March 23, 2005. The order
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`was placed by Jim Kauphusman, who was a VSI engineer working for Jeff Welch
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`on the GuideLiner project. This invoice shows that the hypotubes purchased from
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`Microgroup were machined to create the profile required for construction of the
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`rapid exchange GuideLiner prototype.
`
`
`
`22
`
`
`
`34. Exhibit 2011 is a true and correct copy of an invoice and packing slip
`
`along with a corresponding payment check obtained from VSI’s files relating to
`
`the purchase of the 22 “Guide Liner Distal Sections” from Medical Engineering &
`
`Design Inc. discussed above in connection with Exhibit 2089. As described with
`
`respect to Exhibit 2089, this invoice is for early samples of the distal tubular
`
`portion of rapid exchange GuideLiner prototypes. The price of $145.45 each
`
`further indicates that this was not simply a polymer extrusion, but instead was a
`
`multi-component part that was manufactured to our specifications as shown in
`
`Exhibit 2089. This is consistent with the fact that our rapid exchange GuideLiner
`
`prototypes had a metal coil embedded between a Teflon inner liner and an outer
`
`polymer extrusion with a softer polymer bumper distal tip.
`
`35. Exhibit 2013 is a true and correct copy of invoices and a
`
`corresponding payment check for laser cutting of stainless steel hypotubes by
`
`SPECTRAlytics, which was one of VSI’s vendors for laser cutting hypotubes for
`
`use in rapid exchange GuideLiner prototypes. The order date is listed as March 21,
`
`2005, and indicates that 8 cut hypotubes were shipped to VSI on or about April 4,
`
`2005 and another 12 cut hypotubes were shipped to VSI on or about April 5, 2005.
`
`A stainless steel hypotube was cut using a laser to form the proximal portion of a
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`rapid exchange GuideLiner prototype. The documents indicate that
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`SPECTRAlytics laser cut “blanks” supplied by the customer. This is consistent
`
`
`
`23
`
`
`
`with at least Exhibits 2257, 2007, 2009, 2091, and 2110 above, which relate to
`
`hypotubes purchased by VSI from Microgroup in the preceding weeks.
`
`36. Exhibit 2095 is a copy of two certificates of completion and a sales
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`acknowledgement obtained from the files of SPECTRAlytics. These certificates of
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`completion correspond to the invoices for laser cutting of stainless steel hypotubes
`
`from Exhibit 2013. The laser cut hypotubes supplied by SPECTRAlytics for VSI
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`were only for rapid exchange GuideLiner prototypes and were not used for the
`
`OTW version of GuideLiner.
`
`37. Exhibit 2113 is a three page exhibit showing copies of a VSI
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`engineering drawing for a cut stainless steel hypotube obtained from the files of
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`SPECTRAlytics. The underlying engineering drawing is the same in each page,
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`with the first page indicating that it was received by SPECTRAlytics on March 22,
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`2005, and pages 2-3 indicating that it was received by SPECTRAlytics on March
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`29, 2005. This drawing was for the proximal portion of the rapid exchange
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`GuideLiner and indicates that it was drawn by VSI’s engineer Jim Kauphusman on
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`February 4, 2005. The title of the drawing is “SS HYPO TUBE, CUT” and the
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`drawing number is “SS HYPO X04.” This drawing corresponds to the certificates
`
`of completion of Exhibit 2095 and the invoices of Exhibit 2013. For example, the
`
`certificates of completion of Exhibit 2095 specify that the part that was made was
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`“SS HYPO X04.” The invoices of Exhibit 2013 also refer to “SS HYPO TUBE”
`
`
`
`24
`
`
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`and the “Purchase Order” number 718686 matches the “Customer P.O. #” on the
`
`certificates of completion. The drawing of Exhibit 2113 thus shows what the
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`prototype part looked like that was suppled to VSI by SPECTRAlytics in April
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`2005. The drawings show a design of the proximal portion for the rapid exchange
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`GuideLiner that had multiple angled transition regions bookending non-inclined
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`regions:
`
`Side opening
`
`Machined end for connecting
`to tubular portion
`
`
`
`Rail structure
`
`
`
`38. As described above with respect to the work done at VSI by Mr.
`
`Sutton, Mr. Erb and others, VSI had already built prototype rapid exchange
`
`GuideLiners prior to this order from SPECTRAlytics; however, as work on the
`
`prototypes progressed, VSI built more formal prototypes of the rapid exchange
`
`GuideLiner based on parts received from vendors such as MED and
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`SPECTRAlytics. Once we received the laser cut hypotubes from SPECTRAlytics,
`
`
`
`25
`
`
`
`we promptly combined this with tubular sections already obtained (likely the
`
`“Guide Liner Distal Sections” from Medical Engineering & Design that were
`
`shipped to VSI around April 5, 2005 (Exhibits 2089 and 2011) to make more
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`refined rapid exchange GuideLiner prototypes. These prototypes were then tested
`
`in one or more of the cardiac models discussed above to confirm that they provided
`
`increased backup support and facilitated delivery of balloon catheters and stents
`
`past the distal end of the guide catheter deep within the “coronary artery” of the
`
`model. I quickly realized these prototypes worked as well. Therefore, by April
`
`2005 we had built formal rapid exchange prototypes of GuideLiner that were tested
`
`and understood to have worked for their intended purpose.
`
`39. Exhibit 2016 is a true and correct copy of an invoice and Delivery
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`Note for five Launcher Guide Catheters (size 6 French) purchased from Medtronic
`
`USA, Inc. for use in GuideLiner testing. The invoice is dated April 6, 2005. This
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`is further confirming evidence that GuideLiner devices were being tested in a
`
`cardiac model with guide catheters in early 2005.
`
`40. Exhibit 2017 is a true and correct copy of a June 23, 2005 Memo on
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`Market Feasibility for the GuideLiner catheters. (See also Exhibit 2128, which is
`
`a public, redacted version of Exhibit 2017.) This memo is similar to the February
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`4, 2005 Market Feasibility Memo (Exhibits 2254, 2127) and confirms that as of
`
`
`
`26
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`
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`June 23, 2005 the rapid exchange version of GuideLiner was still being developed,
`
`with an OTW GuideLiner now added to the development project.
`
`41. Exhibit 2018 is a true and correct copy of a July 2005 PowerPoint
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`presentation titled “New Products on the Horizon.” (See also Exhibit 2129, which
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`is a public, red
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