UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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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 Deborah Schmalz
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`I, Deborah Schmalz (formerly Deborah Neymark), 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 March 7, 2020, attached
`
`hereto as Appendix A, remain true and correct, and I hereby adopt and submit
`
`them in connection with the following IPRs before the Patent Trial and Appeal
`
`Board: IPR2020-01341, and IPR2020-01343.
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`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)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Declaration of Deborah Schmalz
`
`I, Deborah Schmalz (formerly Deborah Neymark), 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 March 7, 2020, attached
`
`hereto as Appendix A, remain true and correct, and I hereby adopt and submit
`
`them in connection with the following IPRs before the Patent Trial and Appeal
`
`Board: IPR2020-01341, and IPR2020-01343.
`
`
`
`I declare under penalty of perjury under the laws of the United States of
`
`America that the foregoing is true and correct.
`
`Dated: May 3’ :-
`
`E , 2021
`
`By: mmm
`
`Deborah Schmalz
`
`
`
`
`
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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.
`
`
`
`
`
`
`
`
`
`DECLARATION OF DEBORAH SCHMALZ
`
`
`1
`
`APPENDIX A
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`
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`I, Deborah Schmalz (formerly Deborah Neymark), hereby declare and state
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`as follows:
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`Personal Background
`
`1.
`
`2.
`
`I currently live and work in the Raleigh-Durham North Carolina area.
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`I joined Vascular Solutions, Inc. (“VSI”) in September 2000 as Vice
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`President of Regulatory and Clinical Affairs. I remained in this position until I left
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`VSI in July 2008.
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`3.
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`Prior to joining VSI, I had extensive regulatory affairs experience,
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`holding positions as Vice President of Regulatory at Empi, Regulatory Affairs
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`Manager at Boston Scientific, and Regulatory Affairs Manager at Lifecore
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`Biomedical.
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`Development of GuideLiner
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`4.
`
`The guide extension catheter VSI sells today under the tradename
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`“GuideLiner” was conceived of, developed, tested and a patent was applied for
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`during my tenure at VSI. I was Vice President of Regulatory and Clinical Affairs
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`during the GuideLiner development process, including without limitation in 2004
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`and 2005. In this position, I was involved in and oversaw all regulatory aspects of
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`the GuideLiner development.
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`5.
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`GuideLiner was a fast-moving, high-priority project for VSI. At the
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`beginning, the project involved a rapid exchange version; an over-the-wire version
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`2
`
`
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`was added a short time later and the two versions were worked on concurrently. I
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`recall that the initial development period from the first time I saw a concept
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`drawing to the time a working prototype of the rapid exchange version of
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`GuideLiner was developed was very fast.
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`6.
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`Exhibit 2024 is a Product Requirements document for the GuideLiner
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`Catheter System, dated August 24, 2005. Such a document was created for
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`products at the end of the concept development phase. In practice, this meant that
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`a product must have been prototyped, thoroughly tested, and shown to work for its
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`intended purpose before a Product Requirements document was created. A
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`Product Requirements document marked the start of the Regulatory department’s
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`formal quality process, which ensured regulatory compliance and quality control
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`for products in the commercialization stage. VSI’s quality process was a formal,
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`meticulous, and time-consuming process. Once a Product Requirements document
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`was created, any further changes made or testing performed on the product must be
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`carefully tracked and documented. This quality process was not initiated until a
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`design had been prototyped, tested, and shown to work for its intended purpose.
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`7.
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`The August 24, 2005 Products Requirements document of Exhibit
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`2024 references both the rapid exchange and over-the-wire versions of GuideLiner.
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`We would not have identified both versions if they had not both reached the point
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`of being prototyped, tested, and shown to work for their intended purpose.
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`3
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`
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`Moreover, I specifically recall that a working prototype of the rapid exchange
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`version of GuideLiner was created prior to creation of the August 24, 2005
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`Products Requirements document.
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`8.
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`During my time at VSI, our regulatory quality documents were not
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`stored in an electronic system. All documents were maintained in hard copy
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`format.
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`9.
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`Exhibit 2025 is a Clinical Technical Report dated August 26, 2005,
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`which states that VSI “has developed, and is currently manufacturing four types of
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`catheters” including GuideLiner. Ex. 2025 at 2-3. This Clinical Technical Report
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`confirms that by this time, the rapid exchange version of GuideLiner had advanced
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`beyond the concept development phase. These reports are meant to collect issues
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`identified by the regulatory department that may need to be considered in the
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`process of obtaining FDA approval for a product. This Clinical Technical Report
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`is consistent with both the Product Requirements document and my recollection of
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`the GuideLiner development process.
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`10. Exhibit 2040 is a Memorandum dated August 26, 2005, and addressed
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`to me, memorializing our weekly staff meeting. This memorandum confirms that
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`the Clinical Technical Report (Ex. 2025) discussed in the previous paragraph was
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`updated to include GuideLiner (both rapid exchange and over-the-wire versions)
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`and was circulated for sign-off on August 25, 2005.
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`4
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`
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`11. Exhibit 2041 is part of the materials presented to the Vascular
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`Solutions Board of Directors in connection with its October 2005 meeting. This
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`document contains a Marketing Update from October 2005 provided by VSI’s
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`CEO and one of the GuideLiner inventors, Howard Root, and another employee,
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`Fred Reuning. The Marketing Update explains that the GuideLiner product “has
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`received extremely favorable early concept reviews from our physician advisors.”
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`Ex. 2041 at 4. This demonstrates that GuideLiner had been prototyped, tested, and
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`confirmed to work for its intended purpose before October 2005, which is
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`consistent with my recollection of the GuideLiner development process. Indeed,
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`given that we had received physician feedback by October 2005 is consistent with
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`my recollection that GuideLiner had been prototyped, tested, and confirmed to
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`work for its intended purpose months before that, and certainly before August 24,
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`2005, the date of the Products Requirement document of Exhibit 2024. Obtaining
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`physician feedback took time because products had to be constructed, physician
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`evaluators had to be engaged, the physicians had to evaluate the product, and then
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`provide feedback to us on the product.
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`12. At no time between the start of the regulatory process for GuideLiner
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`in August of 2005 and the filing of the patent application in May 2006 was the
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`rapid exchange GuideLiner project abandoned or paused. The rapid exchange
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`GuideLiner project was always a high priority project during my time at VSI.
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`5
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`
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`I declare under the penalty of perjury that the foregoing is true and correct.
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`Executed on March '1., 2020
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`did/r415 53/; HM
`Deborah Schmalz
`Q:
`
`Page 8
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`Teleflex EX. 2039
`Medtronic v. Teleflex
`
`
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