UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR,INC.
`Petitioners,
`
`V.
`
`TELEFLEX INNOVATIONSS.A.R.L.
`Patent Owner.
`
`IPR2020-01341
`IPR2020-01342
`
`IPR2020-01343
`IPR2020-01344
`
`Declaration of Dean Peterson
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR,INC.
`Petitioners,
`
`V.
`
`TELEFLEX INNOVATIONSS.A.R.L.
`Patent Owner.
`
`IPR2020-01341
`IPR2020-01342
`
`IPR2020-01343
`IPR2020-01344
`
`Declaration of Dean Peterson
`
`
`
`I, Dean Peterson, hereby declare and state as follows:
`
`1.
`
`I make this declaration in connection with evidence submitted by the
`
`Patent Owner in connection with IPRs regarding the following patents: 8,142,413
`
`and RE46,116.
`
`2.
`
`I began working at Vascular Solutions, Inc. as a Research and
`
`Development Engineer in 2005, and I continued in a similar role to the present day.
`
`In 2017, Vascular Solutions, Inc. was acquired by Teleflex Incorporated. In this
`
`declaration I refer to Vascular Solutions, Inc. and Teleflex Incorporated
`
`collectively as “VSI.”
`
`3.
`
`Exhibit 2253 is a true and correct copy of the only substantive pages
`
`of Mr. Sutton’s laboratory notebook 83. Laboratory notebooks, including this
`
`laboratory notebook, are maintained in the regular course of VSI’s business.
`
`4.
`
`Exhibit 2254 is a true and correct copy of a February 4, 2005 memo
`
`regarding Market Feasibility for the GuideLiner catheters. This memo was from
`
`Howard Root, who had contemporaneous knowledge of the information contained
`
`therein. The memo was made as a regular practice of developing a product at VSI
`
`and was maintained in the regular course of VSI’s business on its network.
`
`5.
`
`Exhibit 2256 is a true and correct copy of a February 11, 2005 to June
`
`30, 2006 spend report relating to the GuideLiner development. The report comes
`
`from VSI’s accounting system, which is populated and tracked by VSI personnel
`
`
`
`with knowledge of the information contained therein on or near the date expenses
`
`are incurred. It is a regular practice of VSI to keep such accounting records related
`
`to research and development activities and the records were maintained in the
`
`regular course of VSI’s business.
`
`6.
`
`Exhibit 2257 is a true and correct copy of an invoice and a packing
`
`slip from Microgroup received by VSI, along with the related check voucher from
`
`VSI related to purchased materials. The records were made as a regular practice of
`
`accounting for materials purchased related to VSI development work, and the
`
`records were maintained in the regular course of VSI’s business at Iron Mountain.
`
`7.
`
`Exhibit 2007 is a true and correct copy of an invoice and a packing
`
`slip from Microgroup received by VSI, along with the related check voucher from
`
`VSI related to purchased materials. The records were made as a regular practice of
`
`accounting for materials purchased related to VSI development work, and the
`
`records were maintained in the regular course of VSI’s business at Iron Mountain.
`
`8.
`
`Exhibit 2008 are true and correct copies of invoices and a packing
`
`slips from Medical Profiles & Engineering received by VSI, along with the related
`
`check voucher from VSI related to purchased materials. The records were made as
`
`a regular practice of accounting for materials purchased related to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Iron Mountain.
`
`
`
`9.
`
`Exhibit 2009 is a true and correct copy of an invoice and a packing
`
`slip from Microgroup received by VSI, along with the related check voucher and
`
`email from VSIrelated to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Iron Mountain.
`
`10.
`
`Exhibit 2010 is a true and correct copy of an invoice and a packing
`
`slip from Mountain Machine, Inc. received by VSI, along with the related check
`
`voucher from VSI related to purchased materials. The records were madeas a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Iron Mountain.
`
`11.
`
`Exhibit 2011 is a true and correct copy of an invoice and a packing
`
`slip from Medical Engineering & Design Inc. received by VSI, along with the
`
`related check voucherfrom VSIrelated to purchased materials. The records were
`
`madeas a regularpractice of accounting for materials purchased related to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Iron Mountain.
`
`12.
`
`Exhibit 2013 are a true and correct copies of invoices and a packing
`
`slips from SPECTRAlytics received by VSI, along with the related check voucher
`
`
`
`from VSI related to purchased materials. The records were made as a regular
`
`practice of accounting for materials purchasedrelated to VSI development work,
`
`and the records were maintained in the regular course of VSI’s business at Iron
`
`Mountain.
`
`13.
`
`Exhibit 2016 is a true and correct copy of an invoice and a delivery
`
`note from Medtronic USA Inc received by VSI, along with the related check.
`
`voucherfrom VSIrelated to purchased materials. The records were madeas a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s businessat
`
`Tron Mountain.
`
`14.
`
`Exhibit 2017 is a true and correct copy of a Memo on Market
`
`Feasibility for the GuideLiner catheters. This memo was from Howard Root, who
`
`had contemporaneous knowledge ofthe information contained therein. The memo
`
`was madeas a regular practice of developing a product at VSI and was maintained
`
`in the regular course of VSI’s business on its network.
`
`15.
`
`Exhibit 2018 is a true and correct copy of a PowerPoint presentation
`
`titled “New Products on the Horizon.” The PowerPoint was made by VSI
`
`personnel on or nearthe date in the metadata of the document. The PowerPoint
`
`was madeaspart of the regular practice of preparing for VSI’s sales meetings and
`
`was maintained in the regular course of VSI’s business on its network.
`
`
`
`16.
`
`Exhibit 2020 is a true and correct copy of a certificate of completion
`
`from SPECTRAlytics received by VSI, and an invoice from SPECTRAlIytics
`
`received by VSI, along with the related check voucherfrom VSIrelated to the
`
`provided services. The invoice and check were recorded as a regularpractice of
`
`accounting for materials and services purchasedrelated to VSI development work,
`
`and was maintained in the regular course of VSI’s business at Iron Mountain.
`
`17.
`
`Exhibit 2021 is a true and correct copy of an invoice and a packing
`
`slip from Medical Engineering & DesignInc. received by VSI, along with the
`
`related check voucher from VSI related to purchased materials. The records were
`
`made as a regular practice of accounting for materials purchasedrelated to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Lron Mountain.
`
`18.
`
`Exhibit 2024 is a true and correct copy of an August 24, 2005 Product
`
`Requirements document for the GuideLiner Catheter System. This Product
`
`Requirements document was made by VSI personnel with knowledgeofthe issues
`
`contained therein on or near the date of the document. The document was madeas
`
`a regular practice of developing a product at VSI and was maintained in the regular
`
`course of VSI’s business onits network.
`
`19.
`
`Exhibit 2025 is a true and correct copy of a Clinical Technical
`
`Report. This report was made by VSI personnel with knowledgeofthe issues
`
`
`
`contained therein on or near the date of the report. The report was made as a
`
`regularpractice of developing a product at VSI and was maintainedin the regular
`
`course of VSI’s business on its network.
`
`20.
`
`Exhibit 2026 is a true and correct copy of an invoice and a packing
`
`slip from MicroGroup received by VSL, along with the related check voucher from
`
`VSIrelated to purchased materials. The records were made as a regular practice of
`
`accounting for materials purchased related to VSI development work, and the
`
`records were maintained in the regular course of VSI’s business at Iron Mountain.
`
`21.
`
`Exhibit 2027 is a true and correct copy of invoices and a packingslip
`
`from Johnson Matthey Inc. received by VSI, along with the related check voucher
`
`from VSIrelated to purchased materials. The records were made as a regular
`
`practice of accounting for materials purchased related to VSI development work,
`
`and the records were maintained in the regular course of VSI’s businessat Iron
`
`Mountain.
`
`22.
`
`Exhibit 2028 is a true and correct copy of an invoice a from
`
`SPECTRAIytics received by VSI, along with the related check voucher from VSI
`
`related to purchased materials and services. The records were made as a regular
`
`practice of accounting for materials purchased related to VSI development work,
`
`and the records were maintained in the regular course of VSI’s business at Iron
`
`Mountain.
`
`
`
`23,
`
`Exhibit 2029 are true and correct copies of invoices and a packing
`
`slips from Medical Profiles & Engineering received by VSI, along with the related
`
`check voucher from VSIrelated to purchased materials. The records were made as
`
`a regular practice of accounting for materials purchased related to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Iron Mountain.
`
`24.
`
`Exhibit 2030 is a true and correct copy of an invoice and a packing
`
`slip from Automation & Metrology,Inc. received by VSI, along with the related
`
`check voucher from VSI related to purchased materials. The records were made as
`
`a regular practice of accounting for materials purchasedrelated to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Iron Mountain.
`
`25.
`Exhibit 2031 is a true and correct copy of invoices and a packingslip
`from Automation & Metrology, Inc. received by VSI, along with the related check
`
`voucher from VSIrelated to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Iron Mountain.
`
`26.
`
`Exhibit 2032 are true and correct copies of invoices from Farlow’s
`
`.
`
`Scientific Glassblowing,Inc. received by VSI, along with the related check.
`
`.
`
`
`
`voucher from VSIrelated to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Iron Mountain.
`
`27.
`
`Exhibit 2033 is a true and correct copy of a invoices from Farlow’s
`
`Scientific Glassblowing, Inc. received by VSI, along with the related check
`
`voucher from VSI related to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s businessat
`
`Iron Mountain.
`
`Exhibit 2034is a true and correct copy ofa invoices from Farlow’s
`28.
`Scientific Glassblowing, Inc. received by VSI, along with the related check
`
`voucher from VSI related to purchased materials. The records were madeas a
`
`regularpractice ofaccounting for materials purchased related to VSI development
`work, and the records were maintained in the regular course of VSI’s businessat
`Iron Mountain.
`29,
`Exhibit 2035 is a true and correct copy ofa invoices from Farlow’s
`Scientific Glassblowing,Inc. received by VSI, along with the related check
`
`voucher from VSIrelated to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`
`
`work, and the records were maintained in the regular course of VSI’s businessat
`
`Iron Mountain.
`
`30.
`
`Exhibit 2036 is a true and correct copy of a July 2005 Research &
`
`Development Update written by Gregg Sutton who had contemporaneous
`
`knowledge of the information contained therein. The record was made as a regular
`
`practice of presenting to the Vascular Solution’s Board ofDirectors, and the record
`
`was maintainedin the regular course of VSI’s business on its network.
`
`31.
`
`Exhibit 2040 is a true and correct copy of a Weekly Staff Meeting
`
`Memorandumforthe clinical department at VSI. This Memorandum was from
`
`Rose Griffith (a VSI employee at the time) who had knowledgeof the information
`
`contained therein on or near the date on the document. The Memorandum was
`
`made asa regular practice of VSI’s clinical work and was maintained in the regular
`
`course of VSI’s business on its network.
`
`32.
`Exhibit 2041 is a true and correct copy of the business update section
`ofthe materials presented to the VSI Board ofDirectors for its October 2005
`meeting. This update was made by various VSI employees with knowledge ofthe
`
`information contained therein on or near the date on the document. The record was
`
`made as a regular practice of reporting to VSI’s Board and was maintained in the
`
`regular course of VSI’s business on its network.
`
`10
`
`
`
`33.
`
`Exhibit 2057 is a true and correct copy of a PDF printout of a
`
`Teleflex webpagetitled “Product Patents,” which is publicly available at:
`
`https://www.teleflex.com/usa/en/product-areas/interventional/patents/index. The
`
`information on this website was provided by VSI employees with knowledge of
`
`the information contained therein. The website is madeaspart of the regular part
`
`of VSI’s business to inform the public of its patents and provided publicly from its
`
`webserver in the regular course of VSI’s business.
`
`34.
`
`Exhibit 2058 is a true and correct copy of a PowerPoint presentation
`
`titled “Confidential Presentation to Medtronic” dated September 22, 2016, The
`
`PowerPoint was created by VSI personnel with knowledgeof the information
`
`contained therein on or near the date on the document. This PowerPoint was made
`
`as a regular practice of VSI’s business development and was maintained in the
`
`regular course of VSI’s business on its network.
`
`35.
`
`Exhibit 2061 is a true and correct copy of marketing materials related
`
`to the original GuideLiner (V1) catheter. It was created by VSI personnel with
`
`knowledgeof the information contained therein on or near the date on the
`
`document. The record was made as a regularpractice of marketing VSI’s products
`
`and was maintained in the regular course ofVSI’s business on its network.
`36.
`Exhibit 2062 is a true and correct copy ofmarketing materials related
`
`to the GuideLiner V2 catheter. It was created by VSI personnel with knowledge of
`
`i}
`
`
`
`the information contained therein on or nearthe date on the document. The record
`
`was made as a regular practice of marketing VSI’s products and was maintainedin
`
`the regular course of VSI’s business on its network.
`
`37.
`
`Exhibit 2063 is a true and correct copy of marketing materials related
`
`to the GuideLiner V3 cathetertitled “That’s a Real Game Changer.” It was created
`by VSI personnel with knowledge ofthe information contained therein on ornear
`
`the date on the document. The record was made asa regular practice of marketing
`
`VSI’s products and was maintainedin the regular course of VSI’s business onits
`
`network.
`
`38.
`
`Exhibit 2065 is a true and correct copy of a GuideLiner Catheter
`
`Bibliography dated December 2013. This bibliography was made by VSI
`
`personnel with knowledge of the information contained therein on ornear the date
`
`on the document. The bibliography was made aspart of VSI’s regular marketing
`
`activities and was maintained in the regular course of VSI’s business onits
`
`network.
`
`39.
`
`Exhibit 2066 is a true and correct copy of signed physician
`
`Testimonial Authorization forms submitted as Exhibit 15 to the Declaration of
`
`Howard Root in Support of Plaintiff's Motion for Preliminary Injunction in the
`
`case of Vascular Solutions, Inc. v. Boston Scientific Corporation, 13-cv-01172
`
`(JRT-SER) (D. Minn.). VSI personnel coordinated the signed Testimonial
`
`12
`
`
`
`Authorization forms on or nearthe date of the documents. The signed Testimonial
`
`Authorization forms were made as part of VSI’s regular marketingactivities and
`
`were maintained in the regular course of VSI’s business onits network.
`
`40.
`
`Exhibit 2067 is a true and correct marketing copy of an articletitled,
`
`“The GuideLiner‘child’ catheter” published in Eurolntervention in 2010. A copy
`
`ofthe article was maintained in the regular course of VSI’s business on its
`
`network.
`
`4].
`
`Exhibit 2090is a true and correct copy of two invoices from Farlow’s
`
`Scientific Glassblowing, Inc. received by VSI, along with the related check
`
`voucher from VSI related to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintainedin the regular course of VSI’s businessat
`
`Iron Mountain.
`
`42.
`
`Exhibit 2091is a true and correct copy of an invoice and packing slip
`
`from MicroGroup, Inc. received by VSI, along with the related check voucher from
`
`VSIrelated to purchased materials. The records were madeas a regular practice of
`
`accounting for materials purchasedrelated to VSI development work, and the
`
`records were maintained in the regular course of VSI’s business at Iron Mountain.
`
`43.
`
`Exhibit 2093 is a true and correct copy of an invoice and packing slip
`
`from Automation & Metrology, Inc. received by VSI, along with the related check
`
`13
`
`
`
`voucherfrom VSI related to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchasedrelated to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Tron Mountain.
`
`44,
`
`Exhibit 2094is a true and correct copy of an invoice and packing slip
`
`from MicroGroup,Inc. received by VSI, along with the related check voucher from
`
`VSIrelated to purchased materials. The records were made as a regular practice of
`
`accounting for materials purchasedrelated to VSI development work, and the
`
`records were maintained in the regular course of VSI’s business at Iron Mountain.
`
`45. Exhibit 2097 is a true and correct copy of two invoices from Farlow’s
`
`Scientific Glassblowing, Inc. received by VSI, along with the related check
`
`voucher from VSIrelated to purchased materials. The records were made as a
`
`regularpractice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Iron Mountain.
`
`46.
`
`Exhibit 2099 is a true and correct copy ofa list of VSI’s planned
`
`product developmentprojects from 2006. This list was made by VSI personnel
`
`with knowledge of the information therein on or near the date listed on the face of
`
`the document. The list was made as part of the regular practice of product
`
`14
`
`
`
`developmentat VSI, and was maintained in the regular course of VSI’s business
`
`on its network,
`
`47.
`
`Exhibit 2100 is a true and correct, partially redacted copy of a
`
`document containing VSI’s 2006 Strategic Objectives. The document was made
`
`by VSI personnel with knowledge of the information therein on or nearthe date
`
`listed on the face of the document. The document was made aspart of the regular
`
`practice of strategic planning at VSI, and was maintained in the regular course of
`
`VSI’s business.
`
`48.
`
`Exhibit 2104 is a true and correct copy of an invoice and certificate of
`
`compliance from Vita Needle Company received by VSI, along with the related
`
`check voucherfrom VSIrelated to purchased materials. The records were made as
`
`a regularpractice of accounting for materials purchased related to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Iron Mountain.
`
`49.
`
`Exhibit 2105 is a true and correct, partially redacted copy of a
`
`summary of VSI’s budgetto actual variance. This summary was made by VSI
`
`personnel with knowledgeof the information therein on ornearthe date listed on
`
`the face of the document. The summary was made aspart ofthe regular practice of
`
`accounting at VSI, and was maintained in the regular course of VSI’s business on
`
`its network.
`
`15
`
`
`
`50.
`
`Exhibit 2106is a true and correct copy of four invoices and two
`
`packing lists from LSA received by VSI, along with the related check voucher
`
`from VSI related to purchased materials. The records were made as a regular
`
`practice of accounting for materials purchased related to VSI developmentwork,
`
`and the records were maintained in the regular course of VSI’s business at Iron
`
`Mountain.
`
`51.
`
`Exhibit 2107 is a true and correct copy of an invoice and packing slip
`
`from MicroGroup,Inc. received by VSI, along with the related check voucher from
`
`VSIrelated to purchased materials. The records were madeas a regular practice of
`
`accounting for materials purchasedrelated to VSI development work, and the
`
`records were maintained in the regular course of VSI’s business at Iron Mountain.
`
`52.
`
`Exhibit 2108 is a true and correct copy ofthree invoices and the
`
`corresponding packinglists from LSA received by VSI, along with the related
`
`check voucher from VSI related to purchased materials. The records were made as
`
`a regularpractice of accounting for materials purchasedrelated to VSI
`
`development work, and the records were maintained in the regular course of VSI’s
`
`business at Iron Mountain.
`
`53.
`
`Exhibit 2109 is a true and correct copy of a GuideLiner Team
`
`Meeting Agenda. The document was made by VSI personnel with knowledge of
`
`the information therein on or near the date listed on the face of the document. The
`
`16
`
`
`
`document was madeaspart of the regular practice of product development at VSI,
`
`and was maintained in the regular course of VSI’s business.
`
`54,
`
`Exhibit 2110 is a true and correct copy of an invoice and packingslip
`
`from MicroGroup,Inc. received by VSI, along with the related check voucherfrom
`
`VSIrelated to purchased materials. The records were madeas a regularpractice of
`
`accounting for materials purchasedrelated to VSI development work, and the
`
`records were maintainedin the regular course of VSI’s business at Iron Mountain.
`
`55.
`
`Exhibit 2112 is a true and correct copy of an invoice from Farlow’s
`
`Scientific Glassblowing, Inc. received by VSI, along with the related check
`
`voucherfrom VSI related to purchased materials. The records were made as a
`
`regular practice of accounting for materials purchased related to VSI development
`
`work, and the records were maintained in the regular course of VSI’s business at
`
`Iron Mountain.
`
`56.
`
`Exhibits 2127, 2128, 2129, 2130, and 2133are true and correct,
`
`partially redacted copies of Exhibits 2003, 2018, 2036, and 2041, respectively,
`
`which I addressed above.
`
`57,
`
`Exhibit 2131 is a true and correct, partially redacted copy of Exhibit
`
`2037, which is a documentfiled by Medtronicin the proceeding Vascular
`
`Solutions LLC et al. v. Medtronic, Inc. et al., 0:19-cv-01760-PJS-TNL (D. Minn.),
`
`which purports to consist of the document bearing beginning Bates No.
`
`17
`
`
`
`VSIQXM_E00029190. The document bearing beginning Bates No.
`
`VSIOXM_E00029190 is a true and correct copy of a document containing VSI’s
`
`2006 Strategic Objectives. The document was made by VSI personnel with
`
`knowledge ofthe information therein on or near the date listed on the face of the
`
`document. The document was made aspart ofthe regularpractice of strategic
`
`planning at VSI, and was maintained in the regular course of VSI’s business.
`
`58.
`
`Exhibit 2132 is a true and correct, partially redacted copy of Exhibit
`
`2038, which is a documentfiled by Medtronic the proceeding Vascular Solutions
`
`LLCet al. v. Medtronic, Inc. et al., 0:19-cv-01760-PJS-TNL (D. Minn.), which
`
`purports to consist of the document bearing beginning Bates No.
`
`VSIMDT00031912, The document bearing Bates No. VSIMDT00031912 is a true
`
`and correct copy of a Sales & Marketing Update. The document was made by VSI
`
`personnel with knowledge ofthe information therein on or nearthe date listed on
`
`the face of the document. The document was madeas a part of the regular practice
`
`of presenting to the Board at VSI, and was maintained in the regular course of
`
`VSI’s business on its network.
`
`59.
`
`Exhibit 2134 is a true and correct, partially redacted copy ofa
`
`Research & Development Update. The document was made by VSI personnel
`
`with knowledge of the information therein on or nearthe date listed on the face of
`
`the document. The document was made asa part of the regularpractice of
`
`18
`
`
`
`presenting to the Board at VSI, and was maintained in the regular course of VSI’s
`
`business on its network.
`
`60.
`
`Exhibit 2096 is a true and correct, partially redacted copy of an
`
`invoice from Patterson related to the legal services provided with respectto
`
`GuideLiner, along with the related check voucher from VSI. The records were
`
`made by VSIas part of a regular practice of accounting, and maintained in the
`
`regular course of its business at Iron Mountain.
`
`61.
`
`Exhibit 2101 is a true and correct, partially redacted copy of an
`
`invoice from Patterson related to the legal services provided with respect to
`
`GuideLiner, along with the related check voucher from VSI. The records were
`
`made by VSIas part of a regular practice accounting, and maintainedin the regular
`
`course of its business at Iron Mountain.
`
`62.
`
`Exhibit 2103 is a true and correct, partially redacted copy of an
`
`invoice from Patterson related to the legal services provided with respect to
`
`GuideLiner, along with the related check voucher from VSI. The records were
`
`made by VSI as part of a regular practice of accounting, and maintained in the
`
`regular course ofits business at Iron Mountain.
`
`63.
`
`Exhibit 2117 is a true and correct, partially redacted copy of an
`
`invoice from Patterson related to the legal services provided with respect to
`
`GuideLiner, along with the related check voucher from VSI. The records were
`
`19
`
`
`
`made by VSI as part of a regular practice of accounting, and maintained in the
`
`regular couse of its business at Iron Mountain.
`
`64.
`
`Exhibit 2139 is a true and correct copy of engineering drawings for
`
`GuideLiner Version 1. The drawings were created by VSI personnel with
`
`knowledge of the information therein on or near the date indicated on the face of
`
`the documentas a part of the regularpractice of product development at VSI, and
`
`were maintained in the regular course of VSI’s business.
`
`65.
`Exhibit 2140 is a true and correct copy of engineering drawings for
`GuideLiner Version 2. The drawings were created by VSI personnel with
`
`knowledge of the information therein on or near the date indicated on the face of
`
`the documentas a part of the regular practice of product development at VSI, and
`
`were maintained in the regular course of VSIs business.
`
`66.
`
`Exhibit 2141 is a true and correct copy of engineering drawings for
`
`GuideLiner Version 3. The drawings were created by VSI personnel with
`
`knowledge of the information therein on or near the date indicated on the face of
`
`the documentas a part of the regular practice of product development at VSI, and
`
`were maintained in the regular course of VSI’s business.
`
`67.
`
`Exhibit 2142 is a true and correct copy of the instructions for use for
`
`GuideLiner Version 1. The document was created by VSI personnel with
`
`knowledge of the information therein as a part of the regular practice of obtaining
`
`20
`
`
`
`regulatory approval for new products at VSI, and was maintained in the regular
`
`course of VSI’s business.
`
`68,
`
`Exhibits 2143 and 2209 are true and correct copies of the instructions
`
`for use for GuideLiner Version 2, The documents were created by VSI personnel
`
`with knowledge of the information therein as a part of the regular practice of
`
`obtaining regulatory approval for new products at VSI, and were maintained in the
`
`regular course of VSI’s business.
`
`69.
`
`Exhibit 2144is a true and correct copy of the instructions for use for
`
`GuideLiner Version 3. The document was created by VSI personnel with
`
`knowledge of the information therein as a part of the regular practice of obtaining
`
`regulatory approval for new preducts at VSI, and was maintained in the regular
`
`course of VSI’s business.
`
`70.
`
`Exhibits 2155, 2156, 2157, 2158, 2159, 2160, 2161, 2162, 2163,
`
`2614, and 2165 are true and correct copies of GuideLiner brochures for each year
`
`between 2009 and 2019. The documents were created by VSI personnel with
`
`knowledge of the information therein as a part of the regular practice of product
`
`marketing at VSI, and were maintained in the regular course of VSI’s business.
`
`71.
`
`Exhibits 2181, 2182, 2183, 2185, 2186, 2188, 2189, 2191, 2192, and
`
`2193 are true and correct copies of GuideLinerclinical case reports. These reports
`
`were published by VSI on or near the date indicated by the copyright notice on the
`
`21
`
`
`
`face of the document by an individual with knowledge of the information
`
`contained therein as a part of the regular practice of reporting on uses for medical
`
`devices, and were kept in the ordinary course of VSI’s business.
`
`I declare underpenalty of perjury that the forgoing is true and correct.
`
`Dated: May \Y 2021
`
`By:
`
`Dean Peterson
`
`22
`
`
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