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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`
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`Case IPR2020-01341 (Patent 8,142,413)
`Case IPR2020-01343 (Patent RE 46,116)
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`Declaration of Gregg Sutton
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`I, Gregg Sutton, hereby declare as follows:
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`I previously submitted a declaration in connection with the following IPRs
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`before the Patent Trial and Appeal Board: IPR2020-00126, IPR2020-00128,
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`IPR2020-00129, IPR2020-00132, IPR2020-00134, IPR2020-00135, and IPR2020-
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`00137. My statements from my original declaration dated September 23, 2020,
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`attached hereto as Appendix A, remain true and correct, however I note that the
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`documents labeled as Exhibits 2002, 2003, 2004, 2005, and 2006 in the prior IPRs
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`and referenced in Appendix A, are numbered 2253, 2254, 2255, 2256, and 2257
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`respectively in the present IPRs: IPR2020-01341 and IPR2020-01343. I hereby
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-01341 (Patent 8,142,413)
`Case IPR2020-01343 (Patent RE 46,116)
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`Declaration of Gregg Sutton
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`I, Gregg Sutton, hereby declare as follows:
`
`I previously submitted a declaration in connection with the following IPRs
`
`before the Patent Trial and Appeal Board: IPR2020-00126, IPR2020-00128,
`
`IPR2020-00129, IPR2020-00132, IPR2020-00134, IPR2020-00135, and IPR2020-
`
`00137. My statements from my original declaration dated September 23, 2020,
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`attached hereto as Appendix A, remain true and correct, however I note that the
`
`documents labeled as Exhibits 2002, 2003, 2004, 2005, and 2006 in the prior IPRs
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`and referenced in Appendix A, are numbered 2253, 2254, 2255, 2256, and 2257
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`respectively in the present IPRs: IPR2020-01341 and IPR2020-01343. I hereby
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`
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`adopt my statements from my original declaration dated September 23, 2020, and
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`submit them in connection with the following IPRs before the Patent Trial and
`
`Appeal Board: IPR2020-01341 and IPR2020-01343.
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`
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`I declare under penalty of perjury under the laws of the United States of
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`America that the foregoing is true and correct.
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`Dated: May 1. j , 2021
`
`By:
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`Greg Sutton
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`Pa e 3
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`g
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`Teleflex EX. 2119
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`Medtronic v. Teleflex
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
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`DECLARATION OF GREGG SUTTON
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`1
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`APPENDIX A
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`I, Gregg Sutton, hereby declare and state as follows:
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`1.
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`I make this Declaration in connection with the Patent Owner
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`Response in the IPRs regarding United States Patent Nos. 8,048,032, RE45,380,
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`RE 45,760E, RE45,776, and RE47,379:
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`IPR No.
`IPR2020-00126
`IPR2020-00128
`IPR2020-00129
`IPR2020-00132
`IPR2020-00134
`IPR2020-00135
` IPR2020-00137
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`Patent No.
`8,048,032
`RE45,380
`RE45,380
`RE 45,760E
`RE 45,760E
`RE45,776
`RE47,379
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`
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`2.
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`I began working at Vascular Solutions, Inc. (“VSI”) as Vice President,
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`Research & Development in 2004, and I continued in a similar role until mid-2006.
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`My role was to oversee development of new products for the company. Starting in
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`late-2004 until I left VSI, I performed research and development work on what
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`became the GuideLiner guide extension catheter.
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`3.
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`I am a named inventor on each of the patents described in Paragraph 1
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`of this Declaration. These patents relate to the GuideLiner rapid exchange guide
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`extension catheter. I refer to them, collectively, as the “GuideLiner patents” in this
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`declaration.
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`2
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`4.
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`I have no ongoing involvement in the Teleflex business and I have no
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`financial interest in the outcome of any dispute involving the GuideLiner patents.
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`5.
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`I have reviewed numerous documents that I understand have been
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`maintained in the ordinary course of VSI’s (and now Teleflex’s) business from the
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`time the GuideLiner was developed. I have also reviewed files that I understand
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`have been maintained in the ordinary course of certain of VSI’s vendors from that
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`same timeframe. Unless otherwise noted, I understand that all exhibits referenced
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`herein are true and correct copies of documents that have been maintained in the
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`ordinary course of VSI’s (and now Teleflex’s) business. Documents that have
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`been located in the files of VSI’s vendors will be noted accordingly herein.
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`6.
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`Although I understand that not all of the development files still exist,
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`either in the files of VSI (now Teleflex) or its vendors, based on my memory and
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`the documents that have been located, I know that the GuideLiner was conceived
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`and reduced to practice in prototypes prior to September 2005, and that the steady
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`progression of our work to optimize the GuideLiner rapid exchange for purposes of
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`commercialization continued until I left the company, and as I understand it, after
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`my departure. In short, we knew very early on that the GuideLiner rapid exchange
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`device would work for its intended purpose. The research and development that
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`followed our original conception of the GuideLiner rapid exchange was to
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`optimize materials, dimensions, and design details that would allow us to
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`3
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`manufacture and bring the product to market in a way that would be commercially
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`viable.
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`7.
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`Exhibit 2002 is an excerpt of the only substantive pages of my
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`laboratory notebook labeled Notebook No. 83. The numerical reference means
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`that this was the eighty-third notebook issued to a VSI employee, not the eighty-
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`third notebook that was issued to me, personally. Laboratory notebooks, including
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`my laboratory Notebook No. 83, were issued and maintained in the regular course
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`of VSI’s business. I made and signed the entries in Notebook 83 on the date
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`recorded in the notebook, January 4, 2005, as part of my research and development
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`activities while working at VSI. (Ex. 2002 at 7-8.) These pages are witnessed by
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`the signature of Jeff Welch, who also was an engineer for VSI at the time and who
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`is a co-inventor on the GuideLiner patents. (Id.)
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`8.
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`The laboratory notebook pages in Exhibit 2002 lay out the idea for
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`the GuideLiner rapid exchange device. As shown on the first substantive page
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`describing the concept, the device was known as “Guide-Liner” (the hyphen was
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`later dropped) from the onset. (Ex. 2002 at 7.)
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`9.
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`In these laboratory notebook pages shown in Exhibit 2002, I drew
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`and explained the concept for the GuideLiner rapid exchange, an interventional
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`coronary device designed to access and cross tough or chronic occlusions in the
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`coronary arteries. More specifically, as I wrote, the idea was “to provide a guide
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`4
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`or support catheter more distally into the coronary to provide more back-up
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`support” for delivering stents, specifically where such delivery required “accessing
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`& crossing tough or chronic total occlusions.” (Ex. 2002 at 7.) As I illustrated and
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`noted on these notebook pages, the GuideLiner design allowed for a rapid
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`exchange configuration. (Id. at 7-8.)
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`10. Before this time, interventional cardiologists sometimes used a
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`technique called “mother and child” to extend and provide better support to a
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`standard guide catheter in difficult stent delivery procedures. However, this
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`technique required two guide catheters and a long guidewire. It was a cumbersome
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`process, time-consuming, and not commonly used.
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`11. The GuideLiner rapid exchange shown on Exhibit 2002 had a roughly
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`half-round stainless steel proximal shaft joined to a distal tubular section that was
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`softer, but at least partially reinforced by a braid or coil. (Ex. 2002 at 7.) The half-
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`round proximal shaft would serve as a pushrod for the device. (Id.) The distal end
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`of the tubular section had a radiopaque marker band and a soft distal tip. (Id.)
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`12. The specifications note that the design allowed for rapid exchange and
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`that the device would be one French size smaller than and fit into a standard 6
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`French guide catheter. (Ex. 2002 at 7-8.) The device described would have an
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`outer diameter of 0.065” and an inner diameter of 0.054”, with an overall device
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`5
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`length of 105-115 cm, so that it would be longer than, and extend from, a standard
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`100 cm guide catheter. (Id. at 7.)
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`13.
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`In use, the GuideLiner rapid exchange would be inserted through a
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`standard guide catheter until the distal end of the GuideLiner extended past the
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`distal end of the guide catheter and into the cardiac artery. Once the GuideLiner
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`was in place, an interventional cardiology device, such as a balloon or a stent,
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`would be inserted through the guide catheter (running alongside the GuideLiner’s
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`“rail” and into the GuideLiner distal tube) and ultimately placed in the cardiac
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`artery.
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`14. The lab notebook pages at Exhibit 2002 also show a dilator optionally
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`used in conjunction with the GuideLiner. (Ex. 2002 at 8.) The dilator was not
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`necessary for use of the GuideLiner and was never incorporated into the
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`commercialized device.
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`15. The GuideLiner was originally conceived as a rapid exchange device.
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`For a time VSI also planned to launch an over-the-wire version of the GuideLiner.
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`The over-the-wire version required very little engineering and was relatively easy
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`to build because it was based on existing technology, i.e., essentially two regular
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`guide catheters, or a tube in a tube. Although not novel, we knew VSI could bring
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`an over-the-wire version of the GuideLiner to market fairly quickly and we
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`anticipated fast regulatory clearance from the FDA. As such, VSI pursued an over-
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`6
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`the-wire version of GuideLiner in parallel with our work on the rapid exchange
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`GuideLiner that is shown on Exhibit 2002. However, the work that we did for the
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`over-the-wire version paled in comparison to the work we did to develop and
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`refine the rapid exchange GuideLiner.
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`16. From January 4, 2005 forward, I and others at VSI worked to optimize
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`the rapid exchange version of the GuideLiner for performance, manufacturability,
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`and sale. This involved building prototypes of the invention, performing tests to
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`confirm that the invention would work, and fine-tuning details of the materials and
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`specifications for the device so it could be manufactured and commercialized
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`efficiently.
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`17. Unlike the over-the-wire version, which was based on existing
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`technology, the GuideLiner rapid exchange technology was new. From the time
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`we conceived of the idea in January 2005 through the time I left VSI in mid-2006,
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`we were engaged in an iterative process of working with in-house parts and
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`processing, as well as custom-made components and third-party machining, to
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`build and test prototypes of the GuideLiner rapid exchange so we could optimize
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`its functionality and manufacturability and bring the product to market.
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`18. More specifically, and as detailed in the paragraphs below, soon after
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`we developed the GuideLiner rapid exchange concept in January 2005, we began
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`making prototypes of the device. The earliest prototypes were in large part made
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`7
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`with stock components and machining capabilities we had in-house at VSI. As we
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`continued the prototyping process and refined details of the design, we ordered
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`more specially made parts from vendors and outsourced certain machining
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`services.
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`19. Exhibit 2005 is a copy of a February 11, 2005 to June 30, 2006 spend
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`report relating to the GuideLiner development at VSI. This spreadsheet does not
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`capture all of the expenditures on GuideLiner; for example, it does not capture
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`internal work performed at VSI using existing materials that VSI already had in its
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`inventory.
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`20. The earliest GuideLiner rapid exchange prototypes, made in January
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`or February 2005, had a roughly half-round, stainless steel proximal portion, with a
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`single inclined transition to a full circumference, which was then attached to a
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`distal polymer tubular portion. The machining for these early proximal portions
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`was done at VSI by Steve Erb, a VSI engineering technician and machinist who I
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`understand is still with the company now known as Teleflex. Mr. Erb cut some of
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`the original hypotubing we used for development of the GuideLiner with milling
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`machines we had in house at VSI.
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`21. Additional prototypes, made in the April 2005 timeframe, included a
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`proximal portion that was laser cut and included a complex, multi-angled profile,
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`which was attached to a distal tubular portion that was partially reinforced with
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`8
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`braiding and included a radiopaque marker and a soft tip. The proximal portion of
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`the prototypes from this timeframe is shown in Exhibits 2095 and 2113 and the
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`distal portions of these prototypes is shown in Exhibit 2089.
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`22. Prototypes that we made in the July 2005 timeframe included a
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`proximal stainless steel portion with a multi-step transition between a full
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`circumference and a more significantly cutdown portion, which was then attached
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`to a distal tubular portion, partially reinforced with braiding and including a
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`radiopaque marker and a soft tip. The proximal portion of the prototypes from this
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`timeframe is shown in Exhibits 2111 and 2114 and the distal portion of these
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`prototypes is shown in Exhibit 2092.
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`23. We produced numerous other prototypes, but these were some of the
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`major milestones in the development of the rapid exchange GuideLiner. We knew
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`from building and testing these early prototypes that the product would work and
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`be marketable. We continued to refine the design, working to optimize materials,
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`dimensions, processing, and manufacturability such that the device would both
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`serve physicians’ needs and be commercially feasible. I understand this work
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`continued after I left VSI. Below are further details of the components and
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`processes we used to build and test prototypes of the GuideLiner rapid exchange
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`while I was at VSI.
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`9
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`24. Exhibit 2110 contains an invoice and payment records for an order of
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`20 feet of “304H16XX” hypotubes from MicroGroup that was shipped to VSI on
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`January 14, 2020. A hypotube in the medical device industry is a long metal tube
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`that can be micro-engineered with specialized features along its length.
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`MicroGroup is a vendor that supplies tubing and related parts for the medical
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`device industry. 304H16XX stainless steel is an off-the-shelf product from
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`MicroGroup. The 304H16XX item number indicates that the material was 304H
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`stainless steel and that the size ordered was 16 gauge. The outer diameter of this
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`304H16XX hypotubing is 0.0645” to 0.0655” and the inner diameter is 0.5850” to
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`0.0610”. This stock tubing generally corresponds to the 0.065” and 0.054”
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`dimensions noted on initial GuideLiner drawing shown on Exhibit 2002. This is
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`an order for stock tubing; with this order we were trying to get as close as we could
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`to our desired specifications without yet having to place a custom order. This
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`stainless steel hypotubing was to be cut down to form the pushrod, or rail, that
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`formed the proximal end of the early GuideLiner prototypes. We cut down the
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`GuideLiner hypotubes both in-house and with third-party vendors.
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`25. The stainless steel hypotubing shown in Exhibit 2110 and the other
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`orders for stainless steel and nitinol hypotubing described in this declaration was
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`used for making prototypes of the GuideLiner rapid exchange. The GuideLiner
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`over-the-wire never involved hypotubing.
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`10
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`26. Exhibit 2006 shows another order for stainless steel hypotubes from
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`MicroGroup, shipped to VSI on February 8, 2005. Unlike the first order shown in
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`Exhibit 2110, this order is for custom stainless steel tubing, identified as item
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`number 304Z0067X005WD, which means the tubes were to be 304 stainless steel
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`with an outer diameter of .067” and a wall thickness of .005”. This order is for 60
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`feet of hypotubing, which is consistent with the amount we would have needed in
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`our ongoing development work using hypotubes of different wall thicknesses for
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`the GuideLiner rapid exchange at this time.
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`27. Our work with hypotubes from MicroGroup, which were then cut-
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`down for the GuideLiner rapid exchange, continued. Exhibit 2007 shows a third
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`order of the same custom stainless steel tubing (item number 304Z0067X005WD)
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`from MicroGroup, shipped to VSI on March 3, 2005. Exhibit 2009 shows set up
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`and engineering charges for production of 11 more hypotubes shipped to VSI on
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`March 10, 2005. Exhibit 2091 shows an additional order of 300 feet of
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`304Z0067X005WD custom stainless steel tubing that was shipped to us on March
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`18, 2005. Exhibit 2094 shows another VSI order from MicroGroup, shipped on
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`April 20, 2005, for “MAT-CUT-HYPO.” Although the wording of this order is
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`slightly different than that of the other orders, I believe this simply was another
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`order of the same or similar hypotubes, cut a specified length. In July 2005, we
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`continued ordering hypotubes from MicroGroup. The order shown at Exhibit
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`11
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`2026, shows we ordered 20’ feet each of three additional sizes of hypotubes at that
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`time. The item numbers show that we were ordering stainless steel tubes with
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`different wall thicknesses, specifically in .004”, .005”, and .006”. This order was
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`shipped to VSI on July 14, 2005. All of these orders are consistent with the work
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`we were doing at the time to optimize the materials and dimensions for the
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`proximal section of the GuideLiner rapid exchange device.
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`28. We also considered using Nitinol for the cut-down hypotube, or
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`proximal section of the GuideLiner rapid exchange. Exhibit 2027 shows a March
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`2005 order from Johnson Matthey Inc. for an 84” piece of fully round Nitinol
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`tubing with an outer diameter of .064” and an inner diameter of .055”, which
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`corresponds to the dimensions we were evaluating for the rapid exchange
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`GuideLiner at the time. VSI did not use Nitinol tubing of this kind for any other
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`purpose during this timeframe. These parts were ordered by VSI on March 1, 2005
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`and shipped to us on March 3, 2005. As shown by these invoicing documents, the
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`cost of Nitinol is significantly higher than stainless steel. It also requires certain
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`post-processing steps, which add to the time and cost of production. These factors
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`ultimately weighed against using Nitinol for the proximal portion of the
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`GuideLiner.
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`29. Mountain Machine, Inc. (“Mountain Machine”) is one of the vendors
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`that machined the profiles of the hypotubes that we used for the proximal portion
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`12
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`of the GuideLiner rapid exchange prototypes. Exhibit 2010 shows that on March
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`21, 2005, VSI was invoiced for eight GuideLiner hypotubes that were processed by
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`Mountain Machine. As explained in the handwritten notes, Mountain Machine
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`shipped one unit to us first for evaluation, with seven more shipped on March 21,
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`2005.
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`30. SPECTRAlytics, which specializes in laser cutting metals and
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`polymers for the medical industry, was another one of the vendors we used to cut-
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`down hypotubes for the GuideLiner rapid exchange prototypes. Exhibits 2013,
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`2020, 2095, 2111, 2113, and 2114 contain a series of documents showing these
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`orders. Exhibit 2013 shows that on March 21, 2005, we placed Order No. 996736
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`with SPECTRAlytics to laser cut 20 “blanks” of 105 cm stainless steel hypotubes,
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`“with the reduced diameter machined into the tubing” and “the additional 5 cm . . .
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`to be tailstock behind the area with the reduced ID” and that the cut parts would be
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`electropolished, which is a standard processing step after laser cutting. The
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`tailstock was used to secure the part for any additional machining or processing
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`that might need to be done; it would then be cut when the piece was finished.
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`Exhibit 2113, which I understand was obtained from SPECTRAlytic’s files, is
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`titled “SS HYPO X04”, and shows the drawing that was used for that order.
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`Exhibit 2095, which I understand was also obtained from SPECTRAlytic’s files,
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`shows the Certificates of Completion for this same Order No. 996736, with 8 of
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`13
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`the cut tubes shipped to VSI on April 4, 2005, and the remaining 12 shipped to VSI
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`on April 5, 2005 in accordance with “Customer Drawing # SS HYPO X04.” We
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`used these hypotubes that were laser cut by SPECTRAlytics for the proximal
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`portion of the GuideLiner rapid exchange prototypes.
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`31. We continued to work with SPECTRAlytics to cut down the
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`hypotubes that we were using to make prototypes of the GuideLiner rapid
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`exchange. Exhibit 2020 shows that on June 23, 2005 we placed Order No. 997021
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`with SPECTRAlytics for laser cutting of an additional 20 stainless steel tubes, at
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`least 42” long each, supplied by VSI. (Ex. 2020 at 2.) As shown in the
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`Acknowledgement of this order, SPECTRAlytics machined the step in the outer
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`diameter (“OD”). (Id.) The Part Number for this order is identified as
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`“GUIDELINER NARROW SST”. (Id.) Exhibit 2114, which I understand was
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`obtained from SPECTRAlytic’s files, is titled “GuideLiner Narrow SST”, and
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`shows the drawing that was used for that order. The first page of Exhibit 2020,
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`which is the Certificate of Completion for Order No. 997021, for Part Number
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`“GUIDELINER NARROW SST,” states the order was completed and shipped on
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`July 27, 2005. Exhibit 2111, which I understand was obtained from
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`SPECTRAlytic’s files, shows this same Certificate of Completion and sales
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`Acknowledgement for the same order.
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`14
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`32.
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`In this same early development period, we designed and custom-
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`ordered specially made tubing sections for the distal end of the GuideLiner rapid
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`exchange from another vendor, called Medical Engineering & Design (“MED”).
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`We ordered and used this distal tubing from MED in the process of developing and
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`refining the GuideLiner rapid exchange and making prototypes of the device. I
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`understand that Exhibit 2089 is a collection of documents that were obtained from
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`files maintained in the ordinary course of business of MED and those of MED’s
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`subsequent owners. Page 5 of Exhibit 2089 shows that on February 11, 2005,
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`MED provided Quotation No. 050211-01 for “Guideliner, Distal Section/PTFE
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`Lined DWG# 20-0658 Rev. X01”. Consistent with what is shown in VSI DWG#
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`20-0658 Rev. X01, MED’s Quotation No. 050211-01 details the inner diameter for
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`the part, the length and materials for each section of the tube, an integrated braid in
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`the tube wall, and the specifications for the marker band. Although these
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`documents do not specify that the tubing was for the rapid exchange version of the
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`GuideLiner, the drawings and specifications are specific to a rapid exchange
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`device. For example, the notes section of the quote indicates that the proximal end
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`would be counterbored for .100”. This counterbore, or slight enlargement of the
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`inner diameter of the proximal end of the tube was to facilitate attachment of the
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`distal tubing to the cut-down hypotube, or pushrod, that would form the proximal
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`portion of the rapid exchange GuideLiner. Also, the overall length of the part is
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`15
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`
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`11.8” (about 30 cm). If this part were for an over-the-wire device, it would have
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`been significantly longer.
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`33. Page 7 of Exhibit 2089 is a marked up copy of Quotation No.
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`050211-01, showing a change in the Distal I.D. (inner diameter) from .058” to
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`.057” and a change in the O.D. (outer diameter) from .068” to .066”. The VSI
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`purchase order at page 6 of Exhibit 2089, dated February 17, 2005, shows an order
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`of 20 units of “GUIDELINER DISTAL COMPOUND”, detailing the
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`specifications for the part and noting “PER QUOTE 050211-01 (MARK-UP)”.
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`Page 4 of Exhibit 2089 is a MED Sales Order Acknowledgment dated February
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`28, 2005 reflecting the same order for the “Guideliner Distal Section DWG# 20-
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`0658 Rev. X01-Redlined”. Pages 1-4 of Exhibit 2089 and Exhibit 2011 show that
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`the order we placed in February from MED was shipped in April 2005.
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`34. A second order of the GuideLiner rapid exchange distal section from
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`MED is shown at Exhibits 2021 and 2092. I understand that the documents
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`contained in Exhibit 2092 were obtained from files maintained in the ordinary
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`course of business of MED and those of MED’s subsequent owners. The order
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`reflected in these exhibits was shipped and invoiced on June 16, 2005, and shows
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`an additional order for 21 GuideLiner distal sections, specifying “P/N 02-0658”,
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`which corresponds to the drawing shown on page 8 of Exhibit 2092. As shown in
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`the sales order, quote, purchase order, and drawing of Exhibit 2092, the part
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`16
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`number listed on the invoice and in Exhibit 2021 has a typo: the Part No. was “20-
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`0658” not “02-0658.” There is also a tooling change of $450 for a “design
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`change” on this order, which means we had made additional adjustments to the
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`distal section design. The adjustments between the prior order from MED and the
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`order of Exhibit 2092 were minor, but included: a change in the distal inner
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`diameter of the tube from 0.057” to 0.054”, the proximal inner diameter from .063”
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`to .061”, and the outer diameter of the tube from 0.066” to 0.063,” as well as
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`shortening the distal tip segment from 0.5 cm to 0.2 cm. As discussed further
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`below, we combined these distal sections from MED with the proximal stainless
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`steel sections discussed above to form prototypes of the GuideLiner rapid
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`exchange in April and July 2005. The distal GuideLiner sections from MED were
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`fully formed portions of the rapid exchange GuideLiner, such that once they were
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`attached to a cutdown hypotube, we had a fully formed rapid exchange
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`GuideLiner.
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`35.
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`In making the GuideLiner rapid exchange prototypes, we used an in-
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`house thermal process to fuse the distal tubing sections from MED to the cut-down
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`hypotubes. VSI had all the materials and equipment readily available in house to
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`do this. Specifically, we put a mandrel through the distal tube and aligned it with
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`the cut-down hypotube, placed fluorinated ethylene propylene (“FEP”) heat shrink
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`tubing on the outside of the connection point, and applied heat using heat guns.
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`17
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`
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`After the FEP cooled, the excess was cut away and the mandrel removed, resulting
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`in a unified proximal and distal portion of the GuideLiner prototypes. This same
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`bonding process could be used for both stainless steel and Nitinol.
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`36. Our development work on the GuideLiner also sometimes included
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`forming the profile of the soft tip of the rapid exchange device. Exhibits 2090,
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`2032, 2033, 2034, 2035, 2097, 2112 are a series of documents showing glass
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`forming tips that we ordered from Farlow’s Scientific Glassblowing, Inc.
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`(“Farlow’s”). As these documents show, we were trying a number of different
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`profiles for the tip. Every thousandths of an inch adjustment in the tip profile
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`required a new die.
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`37. Exhibit 2016 shows a Medtronic invoice to VSI for an order of five
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`Launcher 6 French guide catheters placed on April 6, 2005. We ran earlier tests of
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`the GuideLiner rapid exchange prototypes with guide catheters that we had in-
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`house at VSI. We ordered these additional guide catheters from Medtronic for
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`additional testing of the GuideLiner rapid exchange prototypes. As noted on
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`Medtronic’s invoice, this order was shipped to “Vascular Solutions Vendor Trial
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`Research.” (Exhibit 2016 at p. 2.) Because we were testing the prototypes in
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`acrylic and glass heart models, the guide catheters could be used more than one
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`time, and were reused in our ongoing benchtop testing.
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`18
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`
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`38. Another part of our testing of the GuideLiner rapid exchange
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`prototypes involved ring gauges, which we used to measure the outer diameter of
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`the distal section of the GuideLiner rapid exchange, as well as the portion that
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`fused the cut-down hypotube proximal section of the device to the distal section.
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`Ring gauges are a precision measuring tool. Instead of measuring in two
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`dimensions, like a caliper, ring gauges measure three-dimensionally and therefore
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`provide a true three-dimensional fit. Exhibits 2093, 2030 and 2031 show a
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`number of orders for these measurement tools in the April to July 2005 timeframe
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`when we were building and testing prototypes and refining dimensions of the
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`GuideLiner rapid exchange device.
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`39.
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`I, along with Howard Root and others, worked with the attorneys from
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`the law firm of Patterson, Thuente, Skaar & Christensen, P.A. (“Patterson firm”) in
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`the patent prosecution process. I understand that Exhibit 2022 was obtained from
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`files maintained in the Patterson firm’s ordinary course of business. This
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`document is a CAD drawing of a fully-assembled GuideLiner rapid exchange,
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`titled the “Preliminary Design Assumption Rev. X03” for the GuideLiner rapid
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`exchange, dated August 1, 2005. The “X03” means that this is the third version of
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`the CAD drawing for the GuideLiner rapid exchange. We also built and tested the
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`GuideLiner rapid exchange prototypes shown in these drawings.
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`19
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`40. Exhibit 2019, which I understand was obtained from files maintained
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`in the Patterson firm’s ordinary course of business, is partially redacted copy of a
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`fax I sent to the Patterson firm on March 21, 2006. I sent this fax on the date stated
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`on the document as part of my work on GuideLiner while working at VSI. This
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`exhibit includes a June 21, 2005 drawing showing a multi-stepped, cutdown
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`hypotube with a reduced cross-sectional profile near the proximal end of the
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`device. We built prototypes in accordance with the drawings on page 3 of this
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`Exhibit (Ex. 2019 at 3), which are also reflected in Figures 12-16 of the
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`GuideLiner patents. More specifically, we built prototypes with a profile that
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`transitioned from full-round section, to a first short angle, to an extended non-
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`inclined section that is partially cut away, which in turn transitions into a second
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`short angled section, and then to a second non-inclined section that extends to the
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`end of the proximal portion.
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`41. Multiple tests were performed on the early GuideLiner rapid exchange
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`prototypes we built in early to mid-2005. We performed pull tests to determine
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`their durability. We accurately measured their dimensions to ensure they could fit
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`inside guide catheters. We used both two-dimensional acrylic heart models and
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`three-dimensional glass heart models to simulate the use of the rapid exchange
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`GuideLiner prototypes. Sometimes tests involving these models were performed
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`in a heated water bath. Other times the tests were performed using dry models.
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`20
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`For example, we inserted a standard guide catheter into the model, then inserted
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`the rapid exchange GuideLiner and navigated it beyond the distal end of the guide
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`catheter. We observed the forces involved in navigating the GuideLiner through
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`the guide catheter and beyond to determine that it provided backup support. We
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`also delivered stents and balloon catheters through the rapid exchange GuideLiner
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`in these heart models to ensure such interventional cardiology devices could safely
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`be delivered and would not snag or get caught on the device. This testing was
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`more qualitative than quantitative but based on these tests there was no question in
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`our minds that the prototypes we made would work to deliver interventional
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`cardiology devices and provide additional backup support compared to the guide
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`catheter alone. From that point on our work was on making a commercially
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`appropriate version of the GuideLiner rapid exchange.
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`42. Exhibit 2102, which I understand was obtained from files maintained
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`in the Patterson firm’s ordinary course of business, is a partially redacted copy of a
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`fax I sent to the Patterson firm on January 23, 2006. I sent this fax on the date
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`stated on the document as part of my work on GuideLiner while working at VSI.
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`This exhibit contains drawings that I made of the GuideLiner as it would be
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`situated in the aorta. These drawings are the basis for Figures 7, 8, and 9 in the
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`applications for the GuideLiner patents.
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`21
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`43. Exhibit 2036 is a July 2005 Research & Development Update that I
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`wrote for the Board of Directors of VSI. In this document, I am providing a high
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`level and conservative overview to the Board of the various R&D projects that are
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`in process, including the GuideLiner, as shown on page 3 of this exhibit. (Ex.
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`2036 at 3; see also Exhibit 2130, which is a public, redacted version of Exhibit
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`2036.) Although the over-the-wire version was reported as being closer to
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`commercialization than the rapid exchange GuideLiner, I personally don’t recall
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`working on any over-the-wire designs. The over-the-wire design was a very
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`simple project that could easily have been brought to market. My time on the
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`GuideLiner project was spent on the rapid exchange design.
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`44. Exhibit 2024 is the Products Requirements document for the
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`GuideLiner, dated August 24, 2005. This is one of the first documents that is part
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`of the d
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