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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 STEVEN ERB
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`I, Steven Erb, declare as follows:
`1. My name is Steven Erb. I began working for Vascular Solutions, Inc.
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`(“Vascular Solutions” or “VSI”) in 2005 as a Technician in the Research &
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`Development (“R&D”) group. I continue to work for the company today, which is
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`now owned by Teleflex. My title today is Senior Technologist in the R&D group
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`for what is now known as the Interventional Business Unit of Teleflex. The
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`Interventional Business Unit is where the former Vascular Solutions business
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`resides at Teleflex.
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`2. My compensation does not depend in any way on the outcome of this
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`proceeding. I have not been offered any payment, incentive, or inducement to
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`provide this Declaration.
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`3.
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`I have personal knowledge of the facts set forth in this Declaration,
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`except as otherwise stated. I am competent to testify as to all matters stated, and if
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`called upon to do so, I would testify to the facts set forth in this Declaration.
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`4. My responsibilities at Vascular Solutions, and now Teleflex, include
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`machining parts, tool design and fabrication, and assisting engineers on projects.
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`5.
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`I was a member of the R&D group at Vascular Solutions when the
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`company developed the GuideLiner guide extension catheter. I particularly recall
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`working on the GuideLiner in 2005 because it was one of the first products I
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`worked on when I joined the company. I also recall it because it was the first
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`1
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`component-built device I worked on and it was interesting to me from that
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`perspective, as well. I was personally involved in ordering and machining parts
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`that were used for prototyping and testing the device in the research and
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`development process. Although for a time the company considered offering both
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`an over-the-wire and a rapid exchange version of the device, the vast majority of
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`my work was on the GuideLiner rapid exchange. For purposes of this declaration,
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`unless stated otherwise, my references to the “GuideLiner” are specifically to the
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`GuideLiner rapid exchange device.
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`6. When we were first working on the GuideLiner in the 2005-06
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`timeframe, Vascular Solutions was a relatively small company and we were all
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`located on the same floor of the building, situated fairly closely together. The
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`R&D group was centrally located on the floor, with a lab next to us, and a
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`machining room in the back area. We were a hands-on group working on the
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`products that the company was developing, including the GuideLiner. Because of
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`my role in the R&D group, our group’s location on the floor, and the small space
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`that the company occupied in these early years, I was generally aware of the work
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`going on around me, even if I was not directly involved.
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`7.
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`Early in our development process for the GuideLiner, in 2005, we
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`ordered stainless steel and nitinol hypotubes from various vendors to use in
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`prototyping the device. For example, I have reviewed the documents found at
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`2
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`Exhibit 2110 and recognize those to be the invoice, packing slip, and proof of
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`Vascular Solutions’ payment for an order I placed in early January 2005 with
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`Microgroup for stainless steel hypotubes. As shown by the packing slip at the page
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`marked VSIMDT00040846 of Exhibit 2110, that order was shipped overnight to
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`my attention at Vascular Solutions on January 14, 2005. We used these hypotubes
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`to build some of the first prototypes of the GuideLiner rapid exchange device. I
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`did not work on any other products in the 2005-06 timeframe at VSI that used
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`stainless steel or nitinol hypotubes.
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`8.
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`As a machinist for the group, I worked on the early GuideLiner
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`prototypes. Specifically, I machined-down the hypotubes that were used to form
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`the proximal end of the early prototypes of that device. I personally made a special
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`jig to hold the hypotubes and then used a vertical milling machine to cut the tubes
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`along their length. I remember the process well because it is difficult to hold and
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`cut small-diameter tubes like the hypotubes that we used to build the GuideLiner
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`prototypes. Using that jig and the vertical milling machine we had in the R&D lab
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`at Vascular Solutions, I cut-down these early hypotubes into a hemi-cylindrical
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`shape along part of their length. This hemi-cylindrical shape extended all the way
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`to the end of one side of the machined hypotube, while the other end remained in a
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`fully cylindrical shape. The transition between the hemi-cylindrical portion and
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`the full circumference portion had a gradual slope. Machining these parts was an
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`3
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`iterative process, as we kept cutting-away portions of the circumference from the
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`hypotubes to optimize the flexibility of this component of the device. These
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`hypotubes were, in turn used to form the proximal end of the first rapid exchange
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`GuideLiner prototypes in early 2005.
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`9.
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`I also turned-down the hypotubes, using a lathe, to create a “shoulder”
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`on the fully cylindrical, distal end of the hypotube that included a reduced diameter
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`of material so the proximal end of the distal tubular section could fit over it and be
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`attached using an adhesive or reflow process in such a way that the outer surface
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`diameters of the fully cylindrical, distal end of the hypotube and the proximal end
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`of the distal tubular section were substantially the same. This provided a smooth
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`transition between the fully cylindrical, distal end of the hypotube and the proximal
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`end of the distal tubular section of the GuideLiner prototypes.
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`10.
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`In addition to stainless steel hypotubes, we also considered using
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`Nitinol hypotubes. I machined both stainless steel and nitinol hypotubes that were,
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`in turn, each used as the proximal end for early GuideLiner prototypes.
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`11. After I machined-down the hypotubes, they were attached to the
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`polymer distal tubular portion of the device. For a couple of the earliest
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`prototypes, we bonded the machined-down hypotube to the polymer tubular
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`portion with an adhesive. Quickly, however, we began to attach the sections using
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`heat shrink tubing and a reflow process. The attachment of the metal to the
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`4
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`polymer sections was achievable with the adhesives and materials we had in-house
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`at Vascular Solutions for purposes of these early prototypes.
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`12. These prototypes were then tested, including for durability with basic
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`pull-tests and for functionality in two-dimensional benchtop heart models to ensure
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`that the device could get where it needed to go in the vasculature and to understand
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`the forces involved in maneuvering the GuideLiner through the heart model.
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`Although it goes without saying, as part of the testing, we also pulled the
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`GuideLiner prototype back out of the heart models. I personally was involved in
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`some of these tests on the GuideLiner prototypes. I also was aware of, though was
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`not personally involved in, tests of the GuideLiner prototypes involving the
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`delivery of stents and balloons in a benchtop heart model. Whenever a prototype
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`was constructed at Vascular Solutions, it was typical that testing immediately
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`followed. I recall watching Howard Root, Vascular Solutions’ CEO who was
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`actively involved in new product development, and others working in R&D at
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`Vascular Solutions test prototypes on multiple occasions.
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`13. Although we initially machined- and turned-down both the stainless
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`steel and nitinol tubes in-house at Vascular Solutions, we soon moved to laser
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`cutting these parts with outside vendors. We used both LSA and SPECTRAlytics
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`for laser cutting hypotubes for the GuideLiner prototypes.
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`5
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`14.
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`I understand that the pages in Exhibit 2113 were obtained from the
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`files of SPECTRAlytics. This exhibit shows copies of a VSI engineering drawing
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`made by VSI engineer, Jim Kauphusman, on February 4, 2005, titled “SS HYPO
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`TUBE, CUT” with a drawing number of “SS HYPO X04”. This drawing shows
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`the design of the proximal portion VSI used to make GuideLiner prototypes around
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`that time. The left end of the drawing is the distal end of this proximal portion of
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`the GuideLiner, and shows the “shoulder” or turned-down portion that was fitted
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`into and bonded to the distal tubular section.
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`15.
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`I understand that Medtronic has argued in earlier proceedings that the
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`design shown in Exhibit 2113 could actually reflect research and design work for
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`the distal end of the Pronto catheter, an unrelated over-the-wire suction catheter,
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`because they argued that Pronto was under development around the same time as
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`GuideLiner and had at its distal end a similar shape as that shown in this drawing.
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`I worked on Pronto and know that Exhibit 2113 reflects GuideLiner, not Pronto.
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`For one thing, the component shown in Exhibit 2113 is a stainless steel hypotube.
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`We did not use a hypotube of any kind in the development of Pronto and the
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`commercialized Pronto does not use a hypotube, either. The distal end of Pronto is
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`a polymer. Another difference is the dimensions between the GuideLiner proximal
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`section that is shown in Exhibit 2113, which is 20 centimeters long, and the distal
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`6
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`end of Pronto, where the asserted similarly-shaped cutaway is 5 millimeters long
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`(1/40th the length of the GuideLiner section shown in Exhibit 2113).
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`16.
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`I understand that the engineering drawing shown in Exhibit 2114 was
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`obtained from the files of SPECTRAlytics. This drawing was made by Mr.
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`Kauphusman on June 21, 2005, and is titled “NARROW SST GUIDELINER” with
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`a drawing number of “GuideLiner Narrow SST”. This drawing shows the design
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`of the proximal portion of the GuideLiner that VSI used to make prototypes around
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`that time. This design also has a “shoulder”, or turned-down end for mating with
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`the distal tubular section, and that end also has a hole added to help with bonding
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`between the components.
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`17. Although I did not personally place the orders, I also recall VSI
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`ordering and receiving custom reinforced polymer tubes for the distal tubular
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`sections of the GuideLiner prototypes from MED, which is shorthand for Medical
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`Device & Engineering. I have reviewed the documents found at Exhibits 2089,
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`which contains copies of an invoice, packing list, certificate of conformance, sales
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`order acknowledgement, quotation, purchase order, and engineering drawing by
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`Jim Kauphusman that I understand was obtained from MED’s files. These
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`documents show GuideLiner distal tubular sections that MED delivered to VSI in
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`April 2005. Because the GuideLiner was an important new product for us, I recall
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`that we worked with Jeff Berhow on these parts, as Jeff was a high-level person at
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`MED. Pages 5, 6, 7 and 8 of Exhibit 2089 show that we were working with Jeff on
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`the design and ordering of the distal components for the GuideLiner shown in
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`Exhibit 2089. This exhibit also shows a PTFE liner, the different layers of Pebax
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`that were used for these tubes, that it was braid-reinforced, had an unbraided tip,
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`and that the proximal end of the tube was to be counter bored for .100”. This
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`counter bore was to facilitate the attachment of the distal tube over the “shoulder”,
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`or turned-down end, of the proximal hypotube.
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`18.
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`I have also reviewed Exhibit 2092, which contains copies of an MED
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`invoice, packing list, certificate of conformance, sales order acknowledgment,
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`quotation, purchase order, and engineering drawing by Jim Kauphusman for
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`another order of GuideLiner distal tubular sections that were delivered to VSI in
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`June 2005. The drawing for these parts shows they were similar to the earlier
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`distal tubular sections we ordered from MED for GuideLiner prototypes—e.g., a
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`PTFE liner, the different layers of Pebax, braid-reinforced walls with an unbraided
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`tip, and a counterbored distal end to fit over the “shoulder”, or turned-down end, of
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`the proximal hypotube—with slight adjustments to certain dimensions of the tube.
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`19.
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`I primarily was involved in making prototypes before we started
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`outsourcing the laser cutting to LSA and SPECTRAlytics. However, I did help
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`assemble some of the subsequent prototypes. Additional testing, including testing
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`of the kinds mentioned above, was performed on these subsequent prototypes. I
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`recall watching Howard Root and others working in R&D test these subsequent
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`prototypes, as well.
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`20. Although the GuideLiner rapid exchange was not commercialized
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`until several years after these initial prototypes were constructed, we knew from
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`our early testing of prototypes of the device that it would work to provide
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`increased backup support and serve as a launch pad for other catheters including
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`stents and balloons to be delivered beyond the distal end of the GuideLiner. But
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`because it was a first-of-kind product, we were continually working to optimize the
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`design so it could be efficiently and cost-effectively manufactured and reproduced
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`for commercialization. We were able to make several prototypes that worked, but
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`we needed to develop manufacturing processes that were reproducible and a
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`refined design that was able to be commercialized. Work toward this end was
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`consistent from the time of the earliest prototypes through commercialization.
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`21.
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`I recall a significant amount of work that went into ensuring the
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`precise material and dimensions of the proximal portion of GuideLiner would be
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`durable and functional, but also easily reproducible and cost-effective to make.
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`For example, the cut-down stainless steel hypotubes were expensive and could be
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`complicated to manufacture. Nitinol had some advantages, in that it was generally
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`more flexible and could easily recover if it kinked, but nitinol was even more
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`expensive than stainless steel and complicated to machine and finish, and therefore
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`9
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`Page 11
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`Teleflex Ex. 2122
`Medtronic v. Teleflex
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`Page 1
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`Teleflex Ex. 21
`Medtronic v. Teleflex
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`IPR2020-001
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