UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`
`Petitioner,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`
`Patent Owner.
`
`Case IPR2020-01341
`U.S. Patent No. 8,142,413
`
`Case IPR2020-01343
`U.S. Patent No. RE 46,116
`
`DECLARATION OF PAUL ZALESKY REGARDING CONCEPTION AND
`REDUCTION TO PRACTICE SUBMITTED IN SUPPORT OF
`PETITIONER’S REPLY
`
`IPR2020-01343
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`Medtronic Ex-1755
`Medtronic v. Teleflex
`Page 1 of 295
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`
`Petitioner,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`
`Patent Owner.
`
`Case IPR2020-01341
`U.S. Patent No. 8,142,413
`
`Case IPR2020-01343
`U.S. Patent No. RE 46,116
`
`DECLARATION OF PAUL ZALESKY REGARDING CONCEPTION AND
`REDUCTION TO PRACTICE SUBMITTED IN SUPPORT OF
`PETITIONER’S REPLY
`
`IPR2020-01343
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`I, Paul Zalesky, declare as follows:
`
`1.
`
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`
`Inc., and Medtronic Vascular, Inc., (“Petitioner” or “Medtronic”) as an independent
`
`expert to provide my opinions in connection with the following Inter Partes
`
`Review (“IPR”) proceedings: IPR2020-01341 (U.S. Patent No. 8,142,413) and
`
`IPR2020-01343 (U.S. Patent No. RE 46,116) (“second set of IPRs”).
`
`2.
`
`I make this declaration based on personal knowledge. I am over the
`
`age of 21 and am otherwise competent to make this declaration.
`
`3.
`
`I have reviewed the Patent Owner Responses in the second set of IPRs
`
`and the declarations, exhibits, and other materials that Patent Owner cited in
`
`support of its conception and reduction to practice arguments in those Responses. I
`
`have also reviewed the transcripts of the depositions of Peter T. Keith, Howard C.
`
`Root, and Steven J. Erb taken in connection with the second set of IPRs.
`
`4.
`
`I previously offered opinions in connection with related IPR
`
`proceedings: IPR2020-00126, -00128, -00129, -00132, -00134, -00135,
`
`and -00137 (“first set of IPRs”). I previously reviewed materials related to the first
`
`set of IPRs before rendering my opinions. I have reviewed the Board’s Final
`
`Written Decision related to conception and reduction to practice in the first set of
`
`IPRs.
`
`
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`5. My December 17, 2020 declaration submitted in support of
`
`Petitioner’s Reply to Patent Owner’s Response Addressing Conception and
`
`Reduction to Practice in the first set of IPRs, attached here as Appendix A, remains
`
`true and correct.
`
`6.
`
`I understand that the patents at issue in the second set of IPRs—the
`
`’413 and ’116 patents—claim priority to a May 3, 2006 application. I understand
`
`that, in response to the Itou reference (U.S. Patent No. 7,736,355), Patent Owner
`
`has alleged prior invention, including conception in early 2005, actual reduction to
`
`practice before Itou’s effective filing date (September 23, 2005), and conception
`
`before Itou’s effective filing date plus diligence through May 3, 2006 (constructive
`
`reduction to practice).
`
`7.
`
`Based on my review of the materials submitted in connection with
`
`Patent Owner’s conception and reduction to practice arguments in this second set
`
`of IPRs, the arguments and evidence are virtually identical to the conception and
`
`reduction to practice arguments and evidence submitted in the first set of IPRs.
`
`8.
`
`Consistent with the opinions that I offered in the first set of IPRs,
`
`based on my experience and expertise and the materials that I have reviewed, it is
`
`my opinion that the inventions claimed in the ’413 and ’116 patents were not
`
`actually reduced to practice before September 23, 2005. It is also my opinion that
`
`
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`Patent Owner has not shown diligence between alleged conception before
`
`September 23, 2005, and the filing of the patent application on May 3, 2006.
`
`9.
`
`I have extensive experience developing many specialty devices for
`
`Interventional Cardiology. I was struck by the paucity of technical documents and
`
`data cited by Patent Owner. I would normally expect to see a significant
`
`accumulation of “proof-of-concept” documents, including notes, sketches,
`
`diagrams, drawings, crude (but critical) subassembly prototypes, documents
`
`addressing crucial technical issues, and testing data. That accumulation is then
`
`typically filtered and condensed before it is transmitted to patent counsel for
`
`composition of a new patent application. In this case, there is, frankly, more
`
`technical detail in the patents than appears to be in documents in Patent Owner’s
`
`possession from the relevant timeframe. Given the paucity of technical detail
`
`produced, the absence of a filed Provisional Patent Application further augments
`
`my opinion that there was neither actual reduction to practice before September 23,
`
`2005, nor diligence before May 3, 2006.
`
`10.
`
`In short, I have not seen documentary evidence that VSI assembled its
`
`so-called “April” and “July” prototypes before September 23, 2005, that it tested
`
`those prototypes, that it determined from those tests that the inventions would work
`
`for their intended purpose, or that it diligently worked on its prototypes from just
`
`before September 23, 2005 through May 3, 2006. Rather, I have seen evidence that
`
`
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`suggests that VSI did not actually or constructively reduce to practice before
`
`September 23, 2005 or May 3, 2006, respectively.
`
`11.
`
`I have already reviewed the conception and reduction to practice
`
`arguments and evidence submitted in the first set of IPRs, and the vast majority of
`
`those arguments and evidence are submitted in the second set of IPRs.
`
`12.
`
`I understand that Patent Owner submitted substantially the same
`
`exhibits, using the same numbering, in connection with the second set of IPRs
`
`compared to the first set of IPRs. I understand that several exceptions apply:
`
`• Exhibits 2002, 2003, 2004, 2005, and 2006 in the first set of IPRs are
`
`numbered 2253, 2254, 2255, 2256, and 2257, respectively, in the
`
`second set of IPRs.
`
`• Howard Root has added some content to his declaration, Exhibit 2118.
`
`• Steve Erb has added some content to his declaration, Exhibit 2122.
`
`• Peter Keith has adjusted his opinions slightly, Exhibit 2123.
`
`13. Given the overlap in the evidence that Teleflex cited in the first and
`
`second sets of IPRs, I adopt my previous reduction to practice opinions in the
`
`second set of IPRs, and I also opine as follows. The follow paragraphs are
`
`numbered consistent with my previous declaration and begin where that
`
`declaration left off.
`
`
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`Additional Opinions
`
`256. I have reviewed Patent Owner’s evidence, including parts orders, and
`
`compared those parts orders to the drawing depicted in Exhibit 2022. I am not
`
`aware of an order for the proximal component depicted in Exhibit 2022, nor an
`
`order for the part number associated with that component.
`
`257. I previously reviewed laboratory notebooks, including those
`
`belonging to Jim Kauphusman and Katie Mytty. Ex-1760; Ex-1761. In 2005,
`
`Kauphusman and Mytty performed very basic, comparative backup support testing
`
`for VSI’s over-the-wire (OTW) GuideLiner prototypes. Kauphusman and Mytty
`
`performed force testing, comparing a GuideLiner OTW prototype to a standard
`
`guide catheter arrangement. See Ex-1760, 86-93; Ex-1761, 107-13. In my opinion,
`
`this type of testing is very early development testing that would predate regulatory
`
`or commercialization testing. I have not seen any evidence of similar comparative
`
`testing for a GuideLiner RX prototype.
`
`258. I am aware that in connection with the first set of IPRs, the Board
`
`determined that the intended purpose of VSI’s GuideLiner inventions is “to
`
`increase backup support for delivery of interventional cardiology devices,” with
`
`“crossing tough or total occlusions [being] one noted benefit of the invention.”
`
`IPR2020-00128 Final Written Decision (Paper 127), 55-56. I will adopt that
`
`intended purpose for purposes of rendering my opinions here. It is my opinion that
`
`
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`determining that inventions would work for that intended purpose would require at
`
`least (1) setting up a benchtop heart model to simulate an occlusion or a lesion,
`
`(2) advancing a GuideLiner RX prototype through a guide catheter in the model
`
`and past its distal end to test whether the prototype could access and cross the
`
`simulated occlusion, and (3) comparing the prototype’s backup support to a
`
`standard guide catheter arrangement. Appropriate comparative testing would be
`
`similar to the testing that Kauphusman and Mytty performed with respect to
`
`GuideLiner OTW.
`
`259. In signing this declaration, I understand that the declaration will be
`
`filed as evidence in the contested cases before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office. I acknowledge that I may be
`
`subject to cross-examination in this case and that cross-examination will take place
`
`within the United States. If cross-examination is required of me, I will appear for
`
`cross-examination within the United States during the time allotted for cross-
`
`examination.
`
`260. I declare that all statements made herein of my knowledge are true,
`
`and that all statements made on information and belief are believed to be true, and
`
`
`
`
`
`IPR2020-01343
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`that these statements were made with the knowledgethat willful false statements
`
`and the like so made are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`Dated: August 6, 2021
`
`j“op.
`fo~ “7?
`2
`CY x LL id LY .
`
`
`By:
`O Lkby-
`Paul Zalesky, PhD.
`U/
`
`IPR2020-01343
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`IPR2020-01343
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`Appendix A
`Appendix A
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`IPR2020-01343
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`IPR2020-01343
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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.À.R.L.,
`
`Patent Owner.
`
`IPR2020-00126
`IPR2020-00128
`IPR2020-00129
`IPR2020-00132
`IPR2020-00134
`IPR2020-00135
`IPR2020-00137
`
`DECLARATION OF PAUL ZALESKY SUBMITTED IN SUPPORT OF
`PETITIONERS’ REPLY TO PATENT OWNER’S RESPONSE
`ADDRESSING CONCEPTION AND REDUCTION TO PRACTICE
`
`IPR2020-01343
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`TABLE OF CONTENTS
`
`INTRODUCTION ......................................................................................... 1
`I.
`II. QUALIFICATIONS ...................................................................................... 1
`III.
`SUMMARY OF OPINIONS ......................................................................... 6
`IV. LEGAL STANDARDS .................................................................................. 8
`V.
`PERSON OF ORDINARY SKILL IN THE ART .....................................10
`VI. BACKGROUND ON INTERVENTIONAL CARDIOLOGY AND
`THE USE OF CATHETERS AND GUIDE EXTENSION
`CATHETERS IN INTERVENTIONAL CARDIOLOGY
`PROCEDURES ............................................................................................10
`VII. ROOT PATENTS .........................................................................................15
`VIII. INDUSTRY STANDARDS: NEW PRODUCT DEVELOPMENT ........18
`IX. PATENT OWNER’S LACK OF DOCUMENTATION ...........................27
`X.
`LACK OF CONCEPTION BY EARLY 2005 ...........................................30
`XI. LACK OF ACTUAL REDUCTION TO PRACTICE BEFORE
`SEPTEMBER 23, 2005 ................................................................................34
`XII. PATENT OWNER HAS NOT SHOWN THAT RAPID
`EXCHANGE GUIDELINER PROTOTYPES MET ALL
`LIMITATIONS OF ALL CHALLENGED CLAIMS OF THE
`ROOT PATENTS. ........................................................................................87
`XIII. PATENT OWNER DOES NOT ARGUE, MUCH LESS OFFER
`EVIDENCE SHOWING, THAT VSI DETERMINED THAT THE
`RAPID EXCHANGE GUIDELINER WOULD WORK FOR ITS
`INTENDED PURPOSE. .............................................................................87
`XIV. LACK OF DILIGENCE BETWEEN SEPTEMBER OF 2005
`AND MAY OF 2006 .....................................................................................89
`XV. CONCLUSION ............................................................................................95
`
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`I.
`
`Introduction
`1.
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`
`Inc., and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinions in connection with Inter Partes Review (“IPR”) petitions that
`
`have been instituted on five patents: U.S. Pat. Nos. 8,048,032; RE45,380;
`
`RE45,776; RE45,760; and RE45,379 (the “Root patents”): IPR2020-
`
`00126, -00128, -00129, -00132, -00134, -00135, and -00137 (“Itou IPRs”).1
`
`2.
`
`I make this declaration based on personal knowledge. I am over the
`
`age of 21 and am otherwise competent to make this declaration.
`
`II. Qualifications
`3.
`I summarize my educational background and career history in the
`
`following paragraphs. My curriculum vitae is attached as Exhibit 1 to this
`
`declaration.
`
`1 Citations to exhibits refer to exhibits filed in IPR2020-00132 regarding
`
`RE45,760, although I understand that most of Patent Owner’s and Petitioners’
`
`exhibits are numbered consistently across all seven IPRs. I understand that there
`
`are three exceptions: Ex-1108, Ex-1308, and Ex-1708; Ex-1109, Ex-1309, and Ex-
`
`1709; and Ex-1114, Ex-1314, and Ex-1714.
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`4.
`
`Following achievement of a B.S. (Univ. of Notre Dame) and M.S.
`
`(Univ. of Michigan) in Aerospace Engineering, I attained a PhD in Biomedical
`
`Engineering (Univ. of Michigan), publishing my thesis research on the prediction
`
`of optimal surgical timing for the repair of Congenital Heart Defects. My industrial
`
`career has been focused on the development and commercialization of specialty
`
`medical devices for the diagnosis and treatment of heart disease, encompassing
`
`more than 30 years of management and engineering positions in both large and
`
`small companies.
`
`5.
`
`Following the initiation of “interventional” cardiology by Dr. Andreas
`
`Gruntzig in the late ’70s, when he pioneered coronary balloon angioplasty, the
`
`1980s saw the evolution of least invasive treatments of coronary artery disease
`
`(CAD). Today, those treatments are generally referred to as interventional
`
`cardiology. I became directly involved in the development of devices associated
`
`with interventional cardiology. In 1986, I led Boston Scientific’s entry into the
`
`coronary angioplasty (PTCA) market as Director of R&D, presenting device
`
`efficacy data to the FDA towards a soon-approved Pre-Market Application (PMA).
`
`In that role I also supervised the development of guide catheters and guidewires
`
`needed as accessories to angioplasty.
`
`6.
`
`Later in 1986, I co-founded InterTherapy with cardiologist Dr. Walt
`
`Henry. InterTherapy was focused on the development of intravascular ultrasound
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`for assessment of coronary disease that directed subsequent therapy. The
`
`disposable component of the product was a 5 French coronary catheter with design
`
`and materials that enabled its passage through standard guide catheters into the
`
`branches of the coronary artery. From 1986 through 1990 I managed all company
`
`operations, with an emphasis on device use in the cardiac catheterization labs of
`
`Center of Excellence hospitals.
`
`7.
`
`I recruited, and worked closely with, Dr. Martin Leon, then a Fellow
`
`at the National Institutes of Health, and collaborated with Dr. Leon on the creation
`
`of a new, interventional cardiology symposium, Transcatheter Cardiovascular
`
`Therapeutics, which subsequently evolved into the largest and most comprehensive
`
`symposium in the field of interventional cardiology. I also collaborated closely
`
`with cardiologists from multiple U.S. and European Centers of Excellence,
`
`including the Mayo Clinic, Mass General Hospital, UCLA, Rhode Island Hospital,
`
`Emory University, Stanford University, Clinico Cardiologica in Milan, Italy, and
`
`many others. In this, and subsequent professional positions, I participated in
`
`hundreds of patient cases in the cardiac catheter lab, donning protective lead
`
`aprons while assisting or observing patient cases. The InterTherapy technology
`
`effectively enabled the development and evolution of coronary stents, as the real-
`
`time, intravascular imaging enabled review and optimization of stent deployment.
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`8.
`
`In the early ’90s I served as Vice President R&D for a division of
`
`Baxter International, where I led the development of and presented the
`
`corporation’s interventional cardiology product portfolio to cardiologists and
`
`associated symposia, including the development of critical devices for treatment of
`
`CAD.
`
`9.
`
`In 1995 I co-founded, with cardiologist Dr. J. Richard Spears,
`
`TherOx. TherOx was focused on the development of oxygen supersaturated
`
`solutions to the coronary artery, following acute myocardial infarction (heart
`
`attack). The primary product included a sub-selective catheter that could access
`
`distal segments of the coronary branches, for fluid delivery. By sub-selective, I
`
`mean a catheter that can be placed into and advanced through a larger catheter,
`
`sometimes referred to as a “mother-and-child” catheter configuration. Boston
`
`Scientific’s Target Tracker catheter was one such device that was advanced
`
`through a guide catheter into the coronary arteries.
`
`10.
`
`In the 1995 to 2005 time period, myriad guide catheter configurations
`
`were developed and tested by many different companies, including multi-hardness
`
`bodies, multi-flexibility properties, various tip geometries and materials, and
`
`various lumen geometries. Simultaneously, variations on angioplasty devices were
`
`developed and tested, including catheters with active energy capability for lesion
`
`(disease) ablation or removal, miniature balloons on wires, and selective
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`pharmacologic infusions. “Mother-and-child” catheters were developed and
`
`commercialized by this time period. I was directly involved with cardiologist use
`
`and assessment of these devices while directing and participating in formal clinical
`
`studies in the U.S., Europe, Canada, and Israel.
`
`11. During my time with Volcano Corporation (now Philips), I supervised
`
`coronary and peripheral artery catheter development, manufacture, and clinical use.
`
`12.
`
`Since 2013, I have focused on consulting, and I have provided expert
`
`advice or opinions on numerous projects, including related to algorithms for
`
`cardiac arrhythmia diagnosis, implantable cardiac defibrillators, blood oxygen
`
`diagnostic devices, and cardiovascular devices associated with CAD treatment. For
`
`one-and-a-half years I served as interim CEO for Keystone Medical, an Israel-
`
`based start-up for the development of cerebral protection devices for use with
`
`transcatheter heart valve replacement. Our product development activities included
`
`cardiac delivery catheters, guidewires, and associated catheter lab procedures for
`
`device insertion, deployment, use, and removal.
`
`13.
`
`In many of my management positions, I was responsible for
`
`development and maintenance of intellectual property, including direct
`
`management of in-house patent counsel and collaboration with outside patent
`
`counsel. I am a named co-inventor on more than 20 issued U.S. patents, almost all
`
`focused on cardiovascular, coronary artery devices.
`
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`III.
`
`Summary of Opinions
`14.
`I have been asked to review Patent Owner’s Consolidated Response
`
`Addressing Conception and Reduction to Practice,2 as well as Patent Owner’s
`
`declarations and other exhibits in support of the same. I also reviewed transcripts
`
`of depositions of Patent Owner’s declarants taken in the Itou IPRs. I have
`
`additionally reviewed materials produced by Patent Owner in the related, pending
`
`litigation, Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
`
`(D. Minn., filed July 2, 2019), as well as the IPR petitions filed by Medtronic in the
`
`Itou IPRs and the corresponding Institution Decisions, Patent Owner Responses,
`
`and supporting declarations and other exhibits.
`
`15. My opinions have also been guided by my experience and my
`
`appreciation of how a person having ordinary skill in the art would have
`
`understood the claims and the specification of the Root patents at the time of the
`
`alleged invention.
`
`16.
`
`I understand that the Root patents issued from an application initially
`
`filed on May 3, 2006. I understand that, in response to the Itou reference3 cited in
`
`Medtronic’s petitions in the Itou IPRs, Patent Owner has alleged an earlier
`
`2 Referenced herein as Patent Owner’s Brief or “Br.”
`
`3 U.S. Pat. No. 7,736,355, filed September 23, 2005.
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`conception date in January-February 2005, Br. at 3-6, and actual reduction to
`
`practice before September 23, 2005, id. at 7-17. I also understand that Patent
`
`Owner has, in the alternative, alleged conception before September 23, 2005, and
`
`diligence until May 3, 2006. Id. at 18-19.
`
`17. Based on my experience and expertise and the materials that I have
`
`reviewed, it is my opinion that the claims in the Root patents were not conceived
`
`as of January-February 2005. It is also my opinion that the claims in the Root
`
`patents were not actually reduced to practice before September 23, 2005. It is also
`
`my opinion that Patent Owner has not shown diligence between alleged conception
`
`prior to September 23, 2005, and the filing of the patent application on May 3,
`
`2006.
`
`18.
`
`I have extensive experience developing many specialty devices for
`
`Interventional Cardiology. I was struck by the paucity of technical documents and
`
`data cited by Patent Owner. I would normally expect to see a significant
`
`accumulation of “proof-of-concept” documents, including notes, sketches,
`
`diagrams, drawings, crude (but critical) subassembly prototypes, documents
`
`addressing crucial technical issues, and testing data. That accumulation is then
`
`typically filtered and condensed before it is transmitted to patent counsel for
`
`composition of a new patent application. In this case, there is, frankly, more
`
`technical detail in the patents than appears to be in documents in Patent Owner’s
`
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`possession from the relevant timeframe. Given the paucity of technical detail
`
`produced, the absence of a filed Provisional Patent Application further augments
`
`my opinion that there was neither actual reduction to practice before September 23,
`
`2005, nor diligence before May 3, 2006.
`
`19.
`
`I have been asked to opine on the issues specifically discussed in this
`
`declaration. I understand that the petitions and the responses in the Itou IPRs
`
`appear to raise many other issues, but I have not been asked to opine on any of
`
`those other issues in this declaration.
`
`IV. Legal Standards
`20.
`I am not a lawyer and have been informed by counsel of the legal
`
`standards set forth herein.
`
`21.
`
`I am informed that “conception” means the formation, in the mind of
`
`the inventor, of a definite and permanent idea of the complete and operative
`
`invention, as it is thereafter to be applied in practice. I understand that
`
`“conception” must include every feature or limitation of the claimed invention and
`
`that conception is “complete” where an idea is so clearly defined in the inventor’s
`
`minds that only ordinary skill would be required to reduce the invention to
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`practice, without extensive research or experimentation.
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`22.
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`I am informed that an invention can be reduced to practice either
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`constructively or via an actual reduction to practice. I understand that a
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`constructive reduction to practice occurs when a patent application is filed.
`
`23.
`
`I understand that in order to establish an actual reduction to practice,
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`Patent Owner must establish three things: (a) construction of an embodiment that
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`meets all the limitations of a claim at issue; (b) determination that the invention
`
`would work for its intended purpose; and (c) the existence of sufficient evidence to
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`corroborate inventor testimony regarding the same.
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`24.
`
`I understand that one that is first to conceive but second to reduce to
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`practice may nonetheless be considered “first to invent” if she can demonstrate
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`diligence in reducing to practice.
`
`25.
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`I am informed that diligence means “reasonably continuous”
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`diligence. I also understand that the critical period for diligence means from just
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`prior to when the “second party”—here, Itou—reduced to practice and continues
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`until the party who was first to conceive reduces to practice.
`
`26.
`
`I am informed that a “rule of reason” is applied when assessing the
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`sufficiency of corroboration, and that the analysis is fact-specific. I understand that
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`independent knowledge is critical to assessing corroboration. In other words, I
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`understand that—with respect to conception, actual reduction to practice, and
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`diligence—Patent Owner must offer more than just an inventor’s own statements
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`and documents, and that a co-inventor cannot corroborate the testimony of another.
`
`V.
`
`Person of Ordinary Skill in the Art
`27. A person of ordinary skill in the art (“POSITA”) at the time of the
`
`alleged invention would have (a) had a medical degree; (b) completed a coronary
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`intervention training program; and (c) had experience working as an interventional
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`cardiologist. Alternatively, a POSITA would have had (a) an undergraduate degree
`
`in engineering, such as mechanical or biomedical engineering; and (b) three years
`
`of experience designing medical devices, including catheters or catheter-
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`deployable devices. Extensive experience and technical training might substitute
`
`for education, and advanced degrees might substitute for experience. Additionally,
`
`a POSITA with a medical degree may have had access to a POSITA with an
`
`engineering degree, and one with an engineering degree might have had access to
`
`one with a medical degree. Ex-1005 ¶ 31.
`
`VI. Background on Interventional Cardiology and the Use of Catheters and
`Guide Extension Catheters in Interventional Cardiology Procedures
`28. Guide catheters are a common yet critical component of interventional
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`cardiology. They are used by the interventional cardiologist to deliver a balloon or
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`stent into a coronary artery that has been narrowed by a buildup of plaque. The
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`interventional cardiologist first pushes a guide catheter to the ostium of the heart,
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`on a pre-loaded guidewire, to access the desired coronary artery location. With the
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`guide catheter anchored, the guidewire is advanced to and through the targeted
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`lesion site.
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`29. As mentioned above, beginning in the late 1980s, many novel designs
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`and fabrications of guide catheters were introduced, incorporating variations on
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`catheter shaft material and geometry and catheter tip material and geometry and
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`utilizing combinations of guide catheters and guidewires and stabilization in the
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`ascending aorta to enable atraumatic entry into the main coronary artery.
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`Simultaneously, “catheters within catheters” were evaluated and commercialized,
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`to provide greater access during coronary artery treatment, energy delivery, or drug
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`infusion.
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`30. While managing TherOx, for example, in the late ’90s, I directed the
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`refinement of an on-the-market coronary infusion catheter for insertion into and
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`through a commercially available guide catheter. Low profile PTCA and related
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`therapeutic devices were delivered through this same multiple catheter
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`configuration. In my various visits to cardiac catheter labs, it was not uncommon to
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`witness the interventional cardiologist combining otherwise separate, independent
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`catheters towards accessing and treating complex coronary lesions in complex
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`coronary anatomies. Dr. Spears, then at Wayne State University (now at
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`Beaumont, Detroit), and Dr. Williams, then at Rhode Island Hospital (now at
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`Brigham & Women’s, Boston), took this approach on many occasions. Some of
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`these experiences were published in cardiologist publications such as Diagnostic
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`and Interventional Cardiology and Cath Lab Digest.
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`31.
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`The primary skill and capability of interventional cardiologists lies in
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`their hand-to-eye coordination, real-time fluoroscopic imaging of the aorta and
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`coronary anatomy providing a map, and manual manipulation of guidewires, to
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`access even complex, tortuous anatomies and navigate subsequent passage of
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`PTCA or other therapeutic devices. I have witnessed, many times, reorientation of
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`guide catheters in the aorta to both enable access to the coronary arteries via the
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`ostium and to create anchoring geometry to provide backup support in the ostium
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`or main coronary artery. Also, backup support using aorta anchoring is often
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`provided by guide catheter curvatures placed against opposing sides of the aorta,
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`effectively restricting movement of the guide catheter during advancement of
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`therapeutic catheters. In all cases, the interventional cardiologist selects a guide
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`catheter size and tip geometry (curvature) that will provide stable access to the
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`selected coronary artery, based on fluoroscopic images taken before and during
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`treatment. Thus, device manufactures provide numerous catheter tip curvatures and
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`multiple sizes to meet interventional cardiologists’ needs as required for the
`
`particular patient anatomy. The coronary guidewire and guide catheter stability,
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`once positioned, ensures safe and effective access to the targeted lesion.
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`32.
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`If an occlusion is encountered when deploying a therapeutic device
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`that causes the catheter to backup or out or become dislodged from the ostium, the
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`interventional cardiologist has several choices. Those choices include reorientation
`
`of the guide catheter and/or guidewire, use of a different size catheter, use of a
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`different shape catheter, or use of a different brand catheter. Another choice is to
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`add a smaller catheter in a “mother-and-child” configuration. If none of these
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`options are successful in allowing the interventional cardiologist to place the
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`therapeutic device at or through the blockage, the patient may be sent to surgery
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`for a coronary artery bypass graft procedure, which requires open-heart surgery
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`often involving stopping the heart and utilizing a heart-lung bypass machine, a
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`much more complicated and risky approach, with a much longer recovery period.
`
`33.
`
`“Catheter-in-catheter,” or “mother-and-child,” guide catheter use was
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`known since 1992 for difficult coronary or aorta anatomy cases. Ex-1054 (U.S.
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`Pat. No. 5,120,323, “Telescoping Guide Catheter System,” issued to Shockey, et
`
`al). The use of the child catheter functions to extend the guide catheter (here, the
`
`mother catheter) via a second catheter. The child catheter, functioning as an
`
`extension of the mother catheter, can push past the mother catheter and travel
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`down a coronary artery. The child catheter obtains the same benefit as deep seating
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`of the guide catheter, i.e., increased backup support, while avoiding potentially
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`dangerous entry of the larger diameter guide catheter deep into the coronary artery.
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`34.
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`Takahashi, et al. published an article in 2004 disclosing using Terumo
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`devices for percutaneous coronary intervention (PCI), wherein the “mother-and-
`
`child” system was used to extend the system further into the coronary artery and
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`increase backup support. Ex-1010.
`
`35. Guide catheters can be generally cate
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