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
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1755
`Medtronic v. Teleflex
`
`Page 1
`
`
`
`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
`
`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
`
`Medtronic Ex. 1755
`Medtronic v. Teleflex
`
`Page 1
`
`
`
`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
`
`i
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`Page 2
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`I.
`
`Introduction
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`1.
`
`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
`I summarize my educational background and career history in the
`3.
`
`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
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`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.
`
`1
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`Page 3
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`4.
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`Following achievement of a B.S. (Univ. of Notre Dame) and M.S.
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`(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
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`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
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`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
`
`2
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`Page 4
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`
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`for assessment of coronary disease that directed subsequent therapy. The
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`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
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`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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`3
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`Page 5
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`
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`8.
`
`In the early ’90s I served as Vice President R&D for a division of
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`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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`4
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`Page 6
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`
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`
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`pharmacologic infusions. “Mother-and-child” catheters were developed and
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`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.
`
`5
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`Page 7
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`
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`
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`III. Summary of Opinions
`I have been asked to review Patent Owner’s Consolidated Response
`14.
`
`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.
`
`6
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`Page 8
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`
`
`
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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
`
`7
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`Page 9
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`
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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
`I am not a lawyer and have been informed by counsel of the legal
`20.
`
`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
`
`practice, without extensive research or experimentation.
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`8
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`Page 10
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`22.
`
`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
`
`constructive reduction to practice occurs when a patent application is filed.
`
`23.
`
`I understand that in order to establish an actual reduction to practice,
`
`Patent Owner must establish three things: (a) construction of an embodiment that
`
`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
`
`corroborate inventor testimony regarding the same.
`
`24.
`
`I understand that one that is first to conceive but second to reduce to
`
`practice may nonetheless be considered “first to invent” if she can demonstrate
`
`diligence in reducing to practice.
`
`25.
`
`I am informed that diligence means “reasonably continuous”
`
`diligence. I also understand that the critical period for diligence means from just
`
`prior to when the “second party”—here, Itou—reduced to practice and continues
`
`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
`
`sufficiency of corroboration, and that the analysis is fact-specific. I understand that
`
`independent knowledge is critical to assessing corroboration. In other words, I
`
`understand that—with respect to conception, actual reduction to practice, and
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`9
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`Page 11
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`
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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
`
`intervention training program; and (c) had experience working as an interventional
`
`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-
`
`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
`
`cardiology. They are used by the interventional cardiologist to deliver a balloon or
`
`stent into a coronary artery that has been narrowed by a buildup of plaque. The
`
`interventional cardiologist first pushes a guide catheter to the ostium of the heart,
`
`on a pre-loaded guidewire, to access the desired coronary artery location. With the
`
`10
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`Page 12
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`
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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
`
`and fabrications of guide catheters were introduced, incorporating variations on
`
`catheter shaft material and geometry and catheter tip material and geometry and
`
`utilizing combinations of guide catheters and guidewires and stabilization in the
`
`ascending aorta to enable atraumatic entry into the main coronary artery.
`
`Simultaneously, “catheters within catheters” were evaluated and commercialized,
`
`to provide greater access during coronary artery treatment, energy delivery, or drug
`
`infusion.
`
`30. While managing TherOx, for example, in the late ’90s, I directed the
`
`refinement of an on-the-market coronary infusion catheter for insertion into and
`
`through a commercially available guide catheter. Low profile PTCA and related
`
`therapeutic devices were delivered through this same multiple catheter
`
`configuration. In my various visits to cardiac catheter labs, it was not uncommon to
`
`witness the interventional cardiologist combining otherwise separate, independent
`
`catheters towards accessing and treating complex coronary lesions in complex
`
`coronary anatomies. Dr. Spears, then at Wayne State University (now at
`
`Beaumont, Detroit), and Dr. Williams, then at Rhode Island Hospital (now at
`
`Brigham & Women’s, Boston), took this approach on many occasions. Some of
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`11
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`Page 13
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`
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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. The primary skill and capability of interventional cardiologists lies in
`
`their hand-to-eye coordination, real-time fluoroscopic imaging of the aorta and
`
`coronary anatomy providing a map, and manual manipulation of guidewires, to
`
`access even complex, tortuous anatomies and navigate subsequent passage of
`
`PTCA or other therapeutic devices. I have witnessed, many times, reorientation of
`
`guide catheters in the aorta to both enable access to the coronary arteries via the
`
`ostium and to create anchoring geometry to provide backup support in the ostium
`
`or main coronary artery. Also, backup support using aorta anchoring is often
`
`provided by guide catheter curvatures placed against opposing sides of the aorta,
`
`effectively restricting movement of the guide catheter during advancement of
`
`therapeutic catheters. In all cases, the interventional cardiologist selects a guide
`
`catheter size and tip geometry (curvature) that will provide stable access to the
`
`selected coronary artery, based on fluoroscopic images taken before and during
`
`treatment. Thus, device manufactures provide numerous catheter tip curvatures and
`
`multiple sizes to meet interventional cardiologists’ needs as required for the
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`particular patient anatomy. The coronary guidewire and guide catheter stability,
`
`once positioned, ensures safe and effective access to the targeted lesion.
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`12
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`Page 14
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`32.
`
`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
`
`different shape catheter, or use of a different brand catheter. Another choice is to
`
`add a smaller catheter in a “mother-and-child” configuration. If none of these
`
`options are successful in allowing the interventional cardiologist to place the
`
`therapeutic device at or through the blockage, the patient may be sent to surgery
`
`for a coronary artery bypass graft procedure, which requires open-heart surgery
`
`often involving stopping the heart and utilizing a heart-lung bypass machine, a
`
`much more complicated and risky approach, with a much longer recovery period.
`
`33.
`
`“Catheter-in-catheter,” or “mother-and-child,” guide catheter use was
`
`known since 1992 for difficult coronary or aorta anatomy cases. Ex-1054 (U.S.
`
`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
`
`down a coronary artery. The child catheter obtains the same benefit as deep seating
`
`of the guide catheter, i.e., increased backup support, while avoiding potentially
`
`dangerous entry of the larger diameter guide catheter deep into the coronary artery.
`
`13
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`34. 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
`
`increase backup support. Ex-1010.
`
`35. Guide catheters can be generally categorized into one of two styles,
`
`over-the-wire (referred to as “OTW”) designs and rapid exchange (referred to as
`
`“RX” or “Rx”) designs. OTW guide catheters have a lumen that runs the length of
`
`the catheter and allows for the catheter to be placed over a guidewire and advanced
`
`so that the entire catheter runs over the guidewire, with the guidewire extending
`
`out both ends of the catheter. As OTW mother-and child catheters were being
`
`developed in the 1990s, so, too, were extra-long “exchange” guidewires (~300
`
`centimeters long) for use with mother-and-child catheters systems and other OTW
`
`catheter procedures. Use of this guidewire necessitated two operators at the
`
`patient’s side because of the long wire length.
`
`36.
`
`In contrast, RX catheters employ a short lumen near the distal end of
`
`the catheter. That lumen may be the main catheter lumen itself, or a separate lumen
`
`within the catheter structure. The RX catheter configuration allows the catheter to
`
`be advanced within the main guide catheter more easily and quickly by sliding the
`
`catheter rail along a standard-length guidewire, using a single hemostatic valve.
`
`14
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`Page 16
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`RX devices became popular in the early 1990s as an alternative configuration to
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`the OTW configuration.
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`37. Terumo was actively developing mother-and-child catheter systems,
`
`in both an OTW version as disclosed by Takashi and discussed in the specification
`
`of the Root patents, and in a rapid exchange version that was patented, i.e., Itou.
`
`Ex-1007. The Itou patent was filed on September 23, 2005. Id. It issued on June
`
`15, 2010. Id.
`
`38. Takenari Itou was the first-named inventor on the rapid exchange
`
`patent and the sole Terumo co-author of the Takahashi publication. Notably, the
`
`Takahashi publication disclosing the OTW mother-and-child configuration was
`
`revised and accepted for publication on September 10, 2004, and the first patent
`
`application for the Itou patent was filed on September 24, 2004. See Ex-1007 and
`
`Ex-1010. The latter date was just three days before the start of the 2004
`
`Transcatheter Cardiovascular Therapeutics (“TCT”) conference held in
`
`Washington, DC, that ran from September 27 through October 1 that year. Ex-
`
`2118 ¶ 5.
`
`VII. Root Patents
`39. For purposes of describing the Root patents, I refer to the disclosure
`
`of U.S. Pat. No. RE45,760. The ’760 patent is directed “generally to catheters used
`
`in interventional cardiology procedures.” Ex-1001, 1:37-38. The ʼ760 patent
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`15
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`Page 17
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`
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`describes an extension catheter (referred to in the ’760 patent as a “coaxial guide
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`catheter”) that extends through the lumen of and beyond the most distal portion of
`
`the guide catheter (i.e., into the branch artery). Id. at Abstract. More specifically,
`
`the ʼ760 patent purports to describe “a system that [is] deliverable through [a]
`
`standard guide catheter for providing backup support by providing the ability to
`
`effectively create deep seating in the ostium of the coronary artery.” Id. at 3:7-11.
`
`40. The catheter assembly of the ʼ760 patent allegedly has the benefit of a
`
`mother-and-child assembly because it “assists in resisting both the axial forces and
`
`the shearing forces that tend to dislodge a guide catheter from the ostium of a
`
`branch artery.” Id. at 5:31-34.
`
`41. The ’760 patent explains that the coaxial guide catheter 12 has a
`
`tubular portion that includes a flexible distal tip 16 (pink) and a reinforced portion
`
`18 (blue), as well as rigid portion 20 (yellow). Id. at 3:59-64, 6:37-43.
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`
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`16
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`Page 18
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`Id. at Fig. 1 (color and annotations added, annotations made consistent with the
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`language of claims 25, 35).
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`42. The ʼ760 patent also describes the transition at or near the coaxial
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`guide catheter’s reinforced and rigid portions. In some embodiments, the ʼ760
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`patent shows a “side opening” (red circle), which may have an “inclined slope.” Id.
`
`at Figs. 4, 13-16; see also 7:1-17, 8:63-9:3, 13:36-14:7, 14:25-26 (color and
`
`annotations added).
`
`Id. at Fig. 4 (color and annotations added, lower figure inverted to orient figure
`
`similarly to Fig. 1).
`
`43. As shown in the below annotated Figure 9 (color and annotations
`
`added), the ’760 patent shows an extension catheter 12 that is deployed through a
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`17
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`Page 19
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`guide catheter 56. The guidewire 64 and balloon (green) extend distally from the
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`distal tip (pink) of the coaxial guide catheter. In a distal to proximal direction, the
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`coaxial guide catheter’s distal tip (pink) and a reinforced portion (blue) extend out
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`of the distal tip of guide catheter 56.
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`
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`Id. at Fig. 9 (color added).
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`44. The ’760 patent issued to Howard Root, Gregg Sutton, Jeffrey Welch
`
`and Jason Garrity. Id. at (72).
`
`VIII. Industry Standards: New Product Development
`45. There are certain medical device industry practices/standards that are,
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`in my experience, consistently used in new product development for multiple
`
`parallel purposes: (a) protection of proprietary information; (b) design and
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`18
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`development documentation critical to federal regulations and the associated,
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`mandated Quality System; and (c) design and development history recording for
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`later device generation improvements or modifications and reference documents
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`for other company departments, such as manufacturing and quality assurance, as
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`well as for confirmation of marketing requirements.
`
`46.
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`In my experience, new product development always follows a specific
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`sequence of phases, with specific tasks and deliverables associated with each
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`phase, and formal, documented “phase transfer” meetings with document sign-offs.
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`See, e.g., Ex-1771 (FDA, Design Control Guidance for Medical Device
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`Manufacturers, March 11, 1997); Ex-1772 (DHHS, FDA, 21 CFR Parts 808, 812,
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`and 820 (Final Rule, October 7, 1996)).
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`47.
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`In my experience, the earliest phase is the “Concept/Feasibility
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`Phase.” As the name suggests, this is the idea, brainstorming, germination phase
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`for any prospective new product. Usual activities in this phase include concept
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`sketches and drawings, very crude parts and pieces (subassemblies) made by hand
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`from available components or specially ordered materials, brainstorming sessions
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`in group settings, and memos or early technical reports that document the concept
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`and associated issues. Customer needs or Product Requirements usually drive this
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`phase.
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`48.
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`In many cases, feasibility memos or charts are constructed to address
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`critical go/no go issues including market potential, user requirements, technical
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`challenges, competition, regulatory issues or challenges and associated likely
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`regulatory strategy, intellectual property considerations, and theoretical financial
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`results. This phase necessarily precedes the reduction to practice phase(s) typically
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`required for composition of patent applications.4
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`49.
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`In my experience, medical device companies retain documents that
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`are generated by their employees during the Concept/Feasibility Phase, which are
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`placed into the product’s Design History File (“DHF”). Completion of this phase
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`normally includes a formal technical review meeting involving company
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`management, with a multi-consideration feasibility checklist.
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`50. The next phase is the “Design and Development Phase.” While it is
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`often broken down into sequential sub-phases, this phase includes company
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`authorization, via a concept phase review meeting and corresponding document, to
`
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`4 Raising capital for early stage companies requires addressing four critical risk
`
`areas: Technical (invention required, novelty, likely IP, regulatory paths),
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`Marketing (market potential, market dynamics, competition, pricing), Finance
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`(capital required for cash positive, capital versus expense, P&L), and Management
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`(CEO, key staff, Board of Directors).
`
`20
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`begin design efforts for the concept, including preliminary engineering drawings,
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`very early prototyping and early testing, selected market research, and composition
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`of development path Gantt charts that project the time and money required for
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`formal product development and eventual transfer to manufacturing. Preliminary
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`Product Specifications are usually produced early in this phase, then regularly
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`edited as technical information accumulates.
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`51. Sequential prototyping is conducted as design concepts are refined,
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`test protocols are written, and controlled lab testing is conducted and documented.
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`There are periodic technical reports, summarizing engineering and lab work, and
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`monthly summaries of completed tasks with outstanding issues or concerns. The
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`R&D department drives this phase, with occasional interaction with the marketing
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`department, and less occasional interaction with the manufacturing,
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`clinical/regulatory, and quality departments.
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`52. When the responsible parties determine that they have a workable
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`design, with associated support data and documents, an invention disclosure (if
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`warranted) is often prepared and filed with patent counsel. Supporting data and
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`documents include laboratory notebook recordings.
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`53. When a design is close to “freezing,” manufacturing personnel will
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`review the details towards manufacturability, likely cost of goods (COGS), and a
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`detailed Bill of Materials (BOM); regulatory/quality personnel will assess and
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`define associated task and submission details towards future commercialization;
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`and marketing personnel will confirm feature satisfaction. If all management is in
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`agreement, the design is then “frozen” and documented, via formal engineering
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`drawings and a product specification, with a preliminary process specification
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`(manufacturing instructions). The end of this phase includes a formal multi-
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`department meeting and documented sign-off, indicating that the product has a
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`design and is ready for the next phase.
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`54.
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`In my experience, medical device companies retain and carefully
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`control documents that are generated by their employees during the Design and
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`Development Phase. The DHF is the repository of all product/project data and
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`information.
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`55. The next phase in the process is the “Test & Evaluation Phase.” The
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`frozen product specification and preliminary processing specification are utilized
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`to manufacture numbers of devices, with careful documentation of materials and
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`fabrication and inspection steps, to conduct protocol-control
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