`
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`Filed: June 2, 2021
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`MEDTRONIC COREVALVE LLC,
`
`PETITIONER,
`
`V.
`
`COLIBRI HEART VALVE LLC,
`PATENT OWNER.
`___________________
`
`Case No. IPR2020-01454
`U.S. Patent No. 9,125,739
`______________________________________
`
`DECLARATION OF DR. LAKSHMI PRASAD DASI
`
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`TABLE OF CONTENTS
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`
`INTRODUCTION .......................................................................................... 3 
`I. 
`BACKGROUND AND QUALIFICATIONS ................................................ 4 
`II. 
`PERSON OF ORDINARY SKILL IN THE ART ......................................... 9 
`III. 
`IV.  HEART VALVE BACKGROUND ............................................................. 10 
`A.  Anatomy and Function of a Native Heart Valve .......................................... 10 
`B.  TAVR ........................................................................................................... 14 
`C.  Differences Between the Aortic Valve and Mitral Valve ............................ 15 
`V. 
`OVERVIEW OF THE ’739 PATENT ......................................................... 20 
`VI. 
`THE CLAIMS OF THE ’739 PATENT SUBJECT TO REVIEW ............. 23 
`VII.  PROSECUTION HISTORY ........................................................................ 25 
`VIII.  CLAIM CONSTRUCTION ......................................................................... 36 
`A.  “trumpet-like” (claim 1) ............................................................................ 37 
`B.  “valve means” (claim 1) ............................................................................. 38 
`C.  “controlled release mechanism” (claim 5) ............................................... 38 
`IX. 
`RELEVANT LEGAL STANDARDS .......................................................... 39 
`A. 
`Invalidity ....................................................................................................... 39 
`B.  Obviousness .................................................................................................. 39 
`C.  Priority .......................................................................................................... 42 
`D.  Enablement ................................................................................................... 43 
`X. 
`THE ’739 PATENT WOULD NOT HAVE BEEN OBVIOUS TO A
`PERSON OF ORDINARY SKILL IN THE ART .................................................. 44 
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`A.  A Person of Skill Would Not Have Started with Garrison .......................... 45 
`B.  Garrison alone .............................................................................................. 62 
`1.  Garrison was Considered During the ’739 Patent’s Prosecution ............... 62 
`2.  Claim 1 ........................................................................................................ 62 
`3.  Claims 2-5 ................................................................................................... 75 
`C.  Garrison in View of Leonhardt .................................................................... 79 
`1.  Garrison and Leonhardt were considered during the ’739 patent’s
`prosecution .................................................................................................. 80 
`2.  A Person of Skill Would Not Have Combined Garrison with Leonhardt .. 80 
`3.  Claim 1 ........................................................................................................ 86 
`4.  Claims 2-5 ................................................................................................... 93 
`D.  Garrison in View of Nguyen / Garrison in View of Leonhardt and
`Nguyen ......................................................................................................... 93 
`1.  Claim 1 ........................................................................................................ 94 
`E.  Andersen in View of Limon, Garrison, Nguyen, and Gabbay or Phelps ... 100 
`2.  Claim 1 ...................................................................................................... 115 
`3.  Claims 2-5 ................................................................................................. 142 
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`ii
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`I, Dr. Lakshmi Prasad Dasi, hereby declare as follows:
`
`I.
`
`INTRODUCTION
`1.
`I am over the age of eighteen (18) years and otherwise competent to
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`make this declaration.
`
`2.
`
`I have been retained as an expert witness on behalf of Colibri Heart
`
`Valve LLC for the above-captioned inter partes review (“IPR”). I understand that
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`the petition for inter partes review involves U.S. Patent No. 9,125,739 (“the ’739
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`Patent”), Exhibit 1001, which was filed on April 15, 2014. (Ex. 1001 at Cover.)
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`The ’739 Patent issued on September 8, 2015, and names David Paniagua and
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`David Fish as co-inventors. (Id.)
`
`3.
`
`I make this declaration based on my personal knowledge,
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`consideration of the materials I discuss herein, and my expert opinion.
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`4.
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`In preparing this Declaration, I have reviewed the ’739 Patent, the
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`’739 Patent prosecution history, and considered each of the documents cited
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`herein, in light of general knowledge in the art as of January 4, 2002. In
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`formulating my opinions, I have relied upon my experience, education, and
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`knowledge in the relevant art. In formulating my opinions, I have considered the
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`viewpoint of a person of ordinary skill in the art prior to January 4, 2002, as well as
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`the relevant legal standards, including the standard for obviousness.
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`
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`3
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`5.
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`I have been asked to provide my opinions regarding whether
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`Petitioner in this IPR has met its burden of proving that the claims of the ’739
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`Patent at issue are, as Petitioner alleges, obvious in light of Petitioner’s Grounds 1-
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`10 (Petition at 11.) It is my opinion that Petitioner has failed to meet its burden of
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`demonstrating that any of the Challenged Claims would have been obvious to a
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`person of ordinary skill in the art, after reviewing the Petition and its supporting
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`documents.
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`6.
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`This Declaration is being submitted together with the Patent Owner
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`Response to IPR2020-01454, upon which review of claims 1-5 was instituted.
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`II. BACKGROUND AND QUALIFICATIONS
`7.
`I am currently a tenured professor position at Georgia Institute of
`
`Technology in Atlanta, Georgia with the Department of Biomedical Engineering,
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`where I have been since January 1, 2020. I have also been Associate Chair for
`
`Undergraduate Studies since August 1, 2020. In this position, I direct a research
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`program in heart valve engineering, particularly related to emerging transcatheter
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`technologies for both pediatric and adult structural heart diseases.
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`8.
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`In early 2021, I was elected to be a Fellow of the American College of
`
`Cardiology and Fellow of the American Institute of Medical and Biological
`
`Engineering. Fellows of the AIMBE represent the top 2% of the medical and
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`biological engineering community. Similarly, Fellows of the ACC are selected
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`
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`4
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`based on outstanding credentials, achievements, and community contributions to
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`cardiovascular medicine.
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`9.
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`From 2015 through 2019, I was a professor at the Ohio State
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`University, in the Department of Biomedical Engineering, in Columbus, Ohio. I
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`was promoted from Associate to Full Professor with tenure effective June 1, 2019.
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`During my time at the Ohio State University, I directed a research program in heart
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`valve engineering, particularly related to emerging transcatheter technologies for
`
`both pediatric and adult structural heart diseases. At the Ohio State University, I
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`also held courtesy appointments as a Professor in both the Department of Surgery,
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`as well as the Department of Physiology & Cell Biology. I also served as an
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`affiliate faculty member at the Center for Cardiovascular Research, Research
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`Institute at Nationwide Children’s Hospital in Columbus, Ohio.
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`10. From 2009 to 2015, I was appointed as Assistant Professor of
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`Mechanical Engineering at Colorado State University. I also previously held core
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`faculty member status at Colorado State University’s School of Biomedical
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`Engineering. In 2015, I was promoted to Associate Professor. During my time at
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`Colorado State University, I directed a research program in heart valve
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`engineering, particularly related to emerging transcatheter technologies for both
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`pediatric and adult structural heart diseases.
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`
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`5
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`11. From 2004 to 2005, I was a postdoctoral fellow in the Department of
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`Biomedical Engineering at Georgia Tech, and upon completing my fellowship, I
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`was employed as a Research Engineer in the Department of Biomedical
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`Engineering until 2009.
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`12. Throughout my career, much of my research and experience has laid
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`the groundwork for, or directly focused on, the cardiovascular system and heart
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`valves. As part of my formal education and early engineering background, I
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`focused initially on the study of fluid mechanics principles which underlie the
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`cardiovascular system, before further focusing my specialization on cardiovascular
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`research, including with respect to complex congenital heart defects and prosthetic
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`heart valves. From that point, cardiovascular flow and artificial valves became an
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`ever-increasing part of my professional study and research focus. In 2009, I
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`established a research laboratory called the “Cardiovascular & Biofluid Mechanics
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`Laboratory” (CBFL) at Colorado State University. In 2015, I relocated this
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`laboratory to the Ohio State University. This laboratory has a strong emphasis on
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`cardiovascular bioengineering across a broad class of problems in my field
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`focusing on flow physics and physiology.
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`13. My laboratory has a vibrant team of postdocs and students, including
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`doctoral candidates and masters students, who share the common passion of
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`pursuing high-impact research in fluid mechanics and cardiovascular biomechanics
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`
`
`6
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`as it pertains to engineering next-generation diagnostics, therapies, and devices
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`while advancing the fields of engineering and medicine. The postdoctoral scholars
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`I have advised and overseen have gone on to accept positions within industry and
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`academia focusing on cardiovascular research, medicine, and surgery. As a few
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`examples, two of my mentees have accepted faculty positions (Washington
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`University in St. Louis and Michigan Technological University), while another is
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`currently the Chief of Cardiothoracic Surgery at the University of Lorraine, in
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`Nancy, France. Most of my mentees also hold postdoctoral positions in academia
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`and industry (including three working on transcatheter heart valve technologies at
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`Abbott, Medtronic, and W.L. Gore).
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`14.
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`I have been a principal investigator or co-principal investigator on
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`projects that have received over $6.4 million in funding to develop next-generation
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`surgical and transcatheter heart valve technologies, including a $2.9 million
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`National Institutes of Health (NIH) project that was awarded in August 2017. We
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`also received funding from NIH/NCAI as well as Ohio Icorps towards developing
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`new transcatheter heart valve technologies. In addition, we have over $6 million in
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`pending NIH funding on transcatheter heart valve technologies.
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`15.
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`I am a named inventor on three U.S. patents, and have other pending
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`U.S. patent applications, in the field of cardiovascular devices.
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`
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`7
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`16.
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`I serve as Associate Editor for Annals of Biomedical Engineering. I
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`actively peer review grants for the National Institutes of Health, National Science
`
`Foundation, American Heart Association, and several international funding
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`agencies across the world (e.g., Israel, France, Jordan, Kazakhstan). I also actively
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`participate as a peer reviewer for several leading publications in my field:
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`American Journal of Physiology, Annals of Biomedical Engineering,
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`Biomechanics and Modeling in Mechanobiology, Cardiovascular Engineering and
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`Technology, Circulation, Computer Methods in Biomechanics and Biomedical
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`Engineering, Experiments in Fluids, Journal of Biomechanical Engineering –
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`Transactions of the ASME, Journal of Engineering in Medicine, Journal of the
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`Royal Society Interface, Journal of Thoracic and Cardiovascular Surgery, Medical
`
`& Biological Engineering & Computing, Physics of Fluids, and PLOS.
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`17. To date, my work has resulted in over 250 peer-reviewed (refereed)
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`journal and conference publications in the areas of mechanics and cardiovascular
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`research. I am also presently co-authoring a book entitled “The Mechanics of
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`Trans-Catheter and Surgical Heart Valves,” which will be published by Elsevier.
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`This book will reflect contributions leading to products of highly competitive
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`national-level research grants from the NIH, National Science Foundation (NSF),
`
`and American Heart Association (AHA). Its focus will be providing an advanced
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`understanding of prosthetic valve mechanics.
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`
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`8
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`18.
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`I am being compensated for my work in this case at a rate of
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`$400/hour. My compensation is not contingent on the opinions and/or testimony I
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`provide, or the outcome of this case.
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`19. My complete curriculum vitae is attached to this declaration as
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`Exhibit 2027.
`
`20. A list of my deposition and trial testimony for the prior four years is
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`submitted separately as Exhibit 2028.
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`III. PERSON OF ORDINARY SKILL IN THE ART
`21.
`I have been informed that a person of ordinary skill in the art
`
`(“POSA”) is a hypothetical person presumed to be aware of all pertinent art,
`
`understands conventional wisdom in the art, and is a person of ordinary creativity.
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`In these IPR proceedings, I understand that Petitioner has stated that a POSA in
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`January of 2002 would have had a minimum of either a medical degree and
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`experience working as an interventional cardiologist or a Bachelor’s degree in
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`bioengineering or mechanical engineering (or a related field) and approximately
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`two years of professional experience in the field of percutaneously, transluminally
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`implantable cardiac prosthetic devices. Additional graduate education could
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`substitute for professional experience, or significant experience in the field could
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`substitute for formal education. (Petition at 23.)
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`
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`9
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`22. Based on my review of the materials, I do not disagree with
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`Petitioner’s definition of a POSA as of January 4, 2002.
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`23.
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`I provide my opinions in this report based on the perspective of a
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`person of ordinary skill in the art and based on the state of the art as of January 4,
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`2002, which I have been informed is the earliest possible priority date of the ’739
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`Patent.
`
`IV. HEART VALVE BACKGROUND
`A. Anatomy and Function of a Native Heart Valve
`24. The human heart pumps blood through the circulatory systems and is
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`comprised of four chambers, including two upper chambers (the right and left
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`atria) and two lower chambers (the right and left ventricles):
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`
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`10
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`Saw-in ma tac- -——
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`MM atrium
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`Patina" [(1
`Mia! win
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`an-
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`1.41
`umbiliral -
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`
`
`10.60 P131 of the fetal circulation. The arrows momma the direction of
`blood low. The placenta is drawn to a greatly reduced scale.
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`Ex. 2029 at 1501.
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`25. As illustrated above, blood flows through the heart in one direction,
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`with deoxygenated blood entering the heart at the right atrium. See Ex. 2029 at
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`1474-1475- From there, the deoxygenated blood flows through the right
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`atrioventricular valve into the right ventricle. The contraction of the right ventricle,
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`in turn, pumps the deoxygenated blood through the pulmonary valve into the
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`pulmonary artery, which branches into each lung. Oxygenated blood returns from
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`the lungs and enters the heart at the left atrium. From there, the oxygenated blood
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`11
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`flows through the left atrioventricular valve into the left ventricle- The contraction
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`of the left ventricle, in turn, pumps the oxygenated blood through the aortic valve
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`into the aorta, and from there to the arterial system of the body.
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`26.
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`Four natural or “native” valves ensure that blood flows in one
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`direction through the heart: the right and left atrioventricular valves, the pulmonary
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`valve, and the aortic valve- The basic structure and function of these native heart
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`valves is illustrated in the figure below. Each valve includes two or three leaflets
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`(sometimes referred to as flaps or cusps) that are attached at the periphery of the
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`valve (the valve annulus). When blood flows in the correct (forward) direction, the
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`leaflets open away from each other at the center of the valve to allow blood to pass
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`through. When blood flows in the wrong (reverse or retrograde) direction, the
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`backwards pressure causes the leaflets to close against each other at the center of
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`the valve to block blood flow. Ex. 2029 at 1489; see id. at 1477-1489.
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`
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`27.
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`The atrioventricular valves are located inside the heart and regulate
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`blood flow from the atria to the ventricles. During ventricular relaxation (diastole),
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`the atrioventricular valves are open and allow blood to flow through. Then, during
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`12
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`ventricular contraction (systole), the atrioventricular valves close to prevent blood
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`from flowing backward (regurgitating) into the atria. The right atrioventricular
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`valve is located between the right atrium and right ventricle, and it controls the
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`one-way blood flow from the right atrium into the right ventricle. It is often
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`referred to as the “tricuspid” valve because it includes three leaflets. The left
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`atrioventricular valve is located between the left atrium and the left ventricle, and it
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`controls the one-way blood flow from the left atrium into the left ventricle. It is
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`often referred to as the “bicuspid” valve because it includes two leaflets, or as the
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`“mitral” valve because of its resemblance to the tall headdress worn by popes and
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`bishops.
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`28. The pulmonary and aortic valves regulate the blood flow from the
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`ventricles into downstream arteries. During ventricular contraction (systole), the
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`valves open to allow blood to flow into the downstream arteries. Then, during
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`ventricular relaxation (diastole), these valves close to prevent blood from flowing
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`backwards into the ventricles. The pulmonary valve (sometimes referred to as the
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`“pulmonic” valve) is located in the pulmonary artery near the opening of the right
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`ventricle into the pulmonary artery, and it controls the one-way blood flow from
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`the right ventricle to the pulmonary artery (and from there the lungs). The aortic
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`valve is positioned in the aorta near the opening of the left ventricle into the aorta,
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`and it controls the one-way blood flow from the left ventricle to the aorta (and
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`
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`13
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`from there the body). Both the pulmonary and aortic valves have three cusp-like
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`leaflets that snap closed when backwards pressure is exerted on them by retrograde
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`blood flow. These valves are sometimes called “semilunar” valves because of their
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`crescent-shaped cross-section. Given their three-leaflet configuration, they are also
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`sometimes referred to as “tricuspid” valves, though not to be confused with the
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`right atrioventricular valve that is often referred to as the “tricuspid” valve. There
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`are also cases where patients are born with two or even four leaflets instead of
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`three in some situations involving congenital heart defects (e.g., bicuspid aortic
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`valve disease).
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`B.
`
`TAVR
`29. Transcatheter aortic valve replacement (TAVR) is a minimally
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`invasive procedure to replace a native aortic valve that cannot open properly due to
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`calcified leaflets (known as aortic stenosis) with a prosthetic valve device. Before
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`TAVR, replacement of a native aortic valve with a prosthetic valve device
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`generally required open-heart surgery, which involves placing the patient on
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`cardiopulmonary bypass, opening the patient’s chest (thoracotomy), surgically
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`removing or tucking away the native leaflets, and implanting the prosthetic valve
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`device at or near the defective native valve.
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`30. To avoid the need for open-heart surgery and the accompanying risks
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`to the patient’s health, TAVR was developed. During implantation, a TAVR
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`device is compressed to a smaller diameter or profile and inserted into a delivery
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`catheter, and then delivered through the patient’s vasculature to the aortic valve.
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`The catheter typically accesses the heart either transfemorally or transapically. In
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`the transfemoral approach, a small incision is made in the groin, and then the
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`catheter is inserted into the femoral artery and guided to the aortic valve using
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`advanced imaging techniques. In the transapical approach, a small incision is made
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`in the chest, and then the catheter is inserted through a small hole in the apex of the
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`left ventricle. The transfemoral approach is the preferred route because it is less
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`invasive than the transapical route. The patient’s recovery is quicker and there is
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`less risk of vascular injury. Other less preferred routes include the subclavian
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`approach (access via an incision near the shoulder), direct aortic (access via an
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`incision in the chest to expose the aorta), and carotid (access via an incision in the
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`neck), which are typically used when transfemoral is not available. Today,
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`transapical is the least preferred. In 2002, transapical was more preferred than it
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`was today, but transfemoral was still preferred over transapical. Once delivered to
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`the implantation site, the TAVR device is expanded and deployed.
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`C. Differences Between the Aortic Valve and Mitral Valve
`31. There are significant anatomical and physiological differences among
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`the four native heart valves to consider when designing a prosthetic heart valve
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`device. I discuss the differences between the aortic and mitral valve below.
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`
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`32. As explained above, the mitral and aortic valves have different
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`functions. See ¶¶ 27-28 above. The mitral valve regulates blood flow from the left
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`atrium into the left ventricle, and the aortic valve regulates the blood flow from the
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`left ventricle into downstream arteries.
`
`33. The diseases treated in the mitral and aortic valves using a
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`transcatheter prosthetic heart valve device are different. A prosthetic heart valve
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`device is typically implanted in the aortic valve to treat aortic stenosis, which
`
`occurs when the native leaflets calcify and are too stiff to open properly. In the
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`mitral valve, mitral regurgitation is more prevalent than mitral stenosis. Mitral
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`regurgitation occurs when the mitral valve leaflets no longer close all the way
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`during systole and blood flows backwards into the left atrium. Transcatheter
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`prosthetic valve devices for the mitral valve are primarily designed to treat mitral
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`regurgitation.
`
`34. As shown above, the anatomical structures of the aortic and mitral
`
`valves are different. See ¶¶ 26-28 above; Ex. 2030 at 489-513. The aortic valve is
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`smaller than the mitral valve, and its annulus is circular/elliptical. A typical aortic
`
`valve has three leaflets. The valve is also near the coronary arteries in the left
`
`atrium. See Ex. 2029 at 1488. The mitral valve is larger than the aortic valve, and
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`its annulus is dynamic and saddle-shaped. A mitral valve has two leaflets that are
`
`shaped differently than leaflets in the aortic valve. The mitral valve is more
`
`
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`dynamic than the aortic valve. See Ex. 2029 at 1485-1487. The mitral valve also
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`has chordae tendineae, which are dense chord-like structures connecting the
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`leaflets to the papillary muscle. The aortic valve does not have chordae tendineae.
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`The mitral valve is also near the left ventricular outflow tract, obstruction of which
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`is a debilitating, and even deadly, condition. All of these differences make the
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`mitral valve anatomy more complex than the aortic valve anatomy when
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`considering anchoring a transcatheter prosthetic device.
`
`35. These differences are important because the implantation site in both
`
`the aortic valve and mitral valve is the annulus. To ensure that an implanted
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`prosthetic valve device is safe and functions properly, its position must be fixed at
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`the implantation site (here, the annulus). Otherwise, the valve device has a high
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`risk of migrating from the intended implantation site and leaking, especially in
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`light of the movement of the heart walls as it contracts and relaxes and the
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`resulting high-pressure flow of blood. Therefore, it is critical to consider how the
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`prosthetic valve device will anchor in the native annulus, which depends on the
`
`specific native valve anatomy.
`
`36. To anchor a prosthetic heart valve device in the annulus of the aortic
`
`valve, the prosthetic valve device should create a snug fit in the annulus, generally
`
`relying on friction to stay in place. Since the native leaflets are stiff and calcified,
`
`the prosthetic valve device needs significant radial force to push the native leaflets
`
`
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`out of the way and anchor the valve. It is the radial force that creates the friction. In
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`contrast, a prosthetic heart valve device in the mitral valve relies less on anchoring
`
`through friction or radial force but more on hooking onto the native mitral valve
`
`and subvalvular apparatus to anchor the valve device in place. There are also
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`designs that have considered tethering the mitral valve stent to the left ventricular
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`wall, such as at the apex.
`
`37. Another important consideration is how the transcatheter prosthetic
`
`valve device enters the native valve. The leaflets of the prosthetic valve must point
`
`in the same direction as the native leaflets when implanted. The native leaflets of
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`the mitral and aortic valves point in opposite directions relative to one another. I
`
`have explained that the transfemoral and transapical approaches are typically used
`
`to access the aortic valve. See ¶ 30 above. These routes are also used to reach the
`
`mitral valve, but the transfemoral approach is slightly different and involves more
`
`steps when accessing the mitral valve. As with the aortic valve, a small incision is
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`made in the groin for transfemoral access. Then the catheter travels through the
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`femoral vein to the inferior vena cava and then into the right atrium, where a
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`puncture is made between the septum separating the right atrium and left atrium to
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`reach the left atrium. Hence, this is called a transeptal route. This transeptal access
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`is preferred over transapical access because it is a far less invasive procedure.
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`However, the more tortuous, windy transeptal route requires additional steering
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`capabilities for the catheter and the delivery system.
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`38. Due to the significant differences between the aortic and mitral
`
`valves, a person of skill designing a transcatheter prosthetic heart valve device
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`would not start with a prosthetic aortic valve device for treatment in the native
`
`mitral valve or a prosthetic mitral valve device for treatment in the native aortic
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`valve. A transcatheter prosthetic heart valve device is typically designed, tested,
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`and then submitted for FDA approval for treatment of a specific valvular disease,
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`such as aortic stenosis or mitral regurgitation, or to replace a failed prosthetic valve
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`device.
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`39. Currently, there is no TMVR device approved for use in native mitral
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`valves.
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`40. As of January 4, 2002, surgery was the only FDA-approved option to
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`replace an aortic or mitral valve. TAVR was at its infancy at this time. While
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`animal studies and experiments with TAVR were underway, the first-in-human use
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`of a TAVR device was not reported until November 2002. See Ex. 2031 at
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`106:3006. TMVR was at an even less-developed stage, and the first-in-human
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`TMVR implantation did not occur until 2012. See Ex. 2032 at 8:e002135. In
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`January 2002, persons of skill would have understood that they would not take a
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`transcatheter prosthetic mitral valve device and implant it in the aortic valve or
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`19
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`take a transcatheter prosthetic aortic valve device and implant it in the mitral valve.
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`See Ex. 2024 at 105:775-778 (noting that “surgery remains the first-line treatment
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`for valvular insufficiency despite recent advances in pulmonary valve replacement
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`via the percutaneous technique” and discussing an attempt “to develop a stent for
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`aortic valve implantation” through a percutaneous technique). Even today, that is
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`not done. See, e.g., Ex. 2033 at 7(6):724-730.
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`41. The native mitral valve and native aortic valve are anatomically and
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`physiologically different, which is why prosthetic valve devices are designed
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`specifically for implantation in a particular native valve.
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`V. OVERVIEW OF THE ’739 PATENT
`42. Heart disease is the leading cause of death in the United States. Over
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`five million people in the U.S. are diagnosed with heart valve disease annually.
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`Sometimes heart valve disease can be treated with medication, or the diseased
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`heart valve can be repaired through surgery. In severe cases, however, the heart
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`valve is so diseased that it cannot be treated by medication or repaired and must be
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`replaced with an artificial heart valve. Over 100,000 defective heart valves are
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`replaced in the U.S. each year. The ’739 patent is directed to a percutaneous
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`replacement heart valve and a delivery and implantation system. (Ex. 1001,
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`Cover.)
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`20
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`43.
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`I understand that Patent Owner Colibri was co-founded by Drs. David
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`Paniagua and R. David Fish—the inventors of the ’739 patent. Drs. Paniagua and
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`Fish, leading interventional cardiologists and innovators in the field of
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`cardiovascular intervention, have dedicated their careers to addressing the need for
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`treatment options for patients who suffer from debilitating heart valve disease and
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`require a new heart valve. Indeed, Drs. Paniagua and Fish were responsible for one
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`of the first percutaneous heart valve implants, and Dr. Paniagua performed the
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`world’s first retrograde TAVI procedure on a human in 2003. (Ex. 2001, 2-4.)
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`Their work has resulted in the discovery and development of artificial heart valves
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`and treatment methodologies that could offer patients an opportunity to receive a
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`less invasive heart valve therapy. This work became the basis for Colibri’s
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`patented inventions.
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`44. Colibri’s life-saving inventions include a patented, self-expanding
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`heart valve device that includes cross-linked biological tissue and a delivery
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`system that can be guided through a patient’s artery to the heart where it is
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`positioned and used to replace diseased valves. The patented device and
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`mechanism of controlled release, which includes making a small incision through
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`which a thin, flexible tube is inserted into the artery, is far less invasive than open
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`heart surgery. The controlled release capability permits a surgeon to recover the
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`patented heart valve device during deployment. For this innovative replacement
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`21
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`heart valve and system of delivery and implantation, Colibri was awarded the ’739
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`patent.
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`45. Specifically, the claimed system of the ’739 patent is first directed to a
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`prosthetic heart valve, which includes:
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` A stent member that is collapsible, self-expanding, formed from
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`nitinol, configured for transluminal percutaneous delivery, and
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`includes a tubular structure away from a central portion that flares at
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`both end