UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS LIFESCIENCES LLC,
`AND EDWARDS LIFESCIENCES AG
`Petitioners
`
`v .
`
`BOSTON SCIENTIFIC SCIMED, INC.
`Patent Owner
`
`____________
`
`Case IPR2016-
`Patent 8,992,608
`____________
`
`
`
`
`
`DECLARATION OF NIGEL P. BULLER, M.D.
`SUBMITTED ON BEHALF OF PETITIONERS EDWARDS LIFESCIENCES
`CORPORATION, EDWARDS LIFESCIENCES LLC, AND
`EDWARDS LIFESCIENCES AG
`
`
`
`
`
`
`
`Edwards Lifesciences Corporation, et al. Exhibit 1107, Page 1 of 122
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`

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`
`TABLE OF CONTENTS
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`A.
`
`Engagement ........................................................................................... 1
`
`B.
`
`Background and Qualifications ............................................................ 2
`
`II.
`
`LEGAL STANDARDS ................................................................................... 7
`
`A. Anticipation ........................................................................................... 7
`
`B. Obviousness .......................................................................................... 8
`
`III. ORDINARY SKILL IN THE ART .............................................................. 10
`
`IV. BACKGROUND OF THE RELEVANT TECHNOLOGY ......................... 11
`
`A.
`
`Surgical Prosthetic Heart Valves ........................................................ 11
`
`B.
`
`C.
`
`Evolution of Stent Technology ........................................................... 14
`
`Stent Foreshortening ........................................................................... 17
`
`D.
`
`Stent Grafts and Use of Fabric Covering to Prevent Endoleaks ........ 19
`
`E.
`
`Transcatheter Heart Valve Technology .............................................. 32
`
`V.
`
`SUMMARY OF THE ’608 PATENT .......................................................... 41
`
`VI. CLAIMS 1-4 OF THE ’608 PATENT .......................................................... 51
`
`VII. PROSECUTION HISTORY OF THE ’608 PATENT ................................. 53
`
`VIII. PROPOSED CONSTRUCTIONS OF CLAIM TERMS .............................. 59
`
`IX.
`
`INVALIDITY OF CLAIMS 1-4 OF THE ’608 PATENT ........................... 66
`
`A. Ground 1: Cribier Anticipates Claims 1-4 of the ’608 Patent ............ 68
`
`B. Obviousness ........................................................................................ 74
`
`(a) Ground 2: Cribier in View of Spiridigliozzi (Claims 1-4) ....... 74
`
`(b) Grounds 3-4: Cribier in View of Elliot (Ground 3) or
`Thornton (Ground 4) (Claims 1-4) ........................................... 77
`
`
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`(c) Ground 5: Cribier in View of Cook (Claims 1-4) .................... 82
`
`(d) Ground 6: Cribier in view of De Paulis (Claims 1-4) .............. 85
`
`(e) Grounds 7-8: Spenser in view of Elliot (Ground 7) or
`Thornton (Ground 8) (Claims 1-4) ........................................... 87
`
`(f) Ground 9: Spenser in view of Cook (Claims 1-4) .................... 92
`
`(g) Ground 10: Spenser in view of De Paulis (Claims 1-4) ........... 93
`
`C. Ground 11: Spenser Anticipates Claims 1-4 of the ’608 Patent ......... 94
`
`X.
`
`CONCLUSION ............................................................................................. 95
`
`
`
`
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`
`I, Dr. Nigel P. Buller, declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I am over the age of eighteen (18) and otherwise competent to make
`
`this Declaration.
`
`A. Engagement
`
`2.
`
`I have been retained on behalf of Edwards Lifesciences
`
`Corporation, Edwards Lifesciences LLC, and Edwards Lifesciences AG (collectively,
`
`“Edwards”) to provide my opinion on the state of endovascular prosthetic technology
`
`and the scope and content of certain “prior art” patents and printed publications
`
`predating June 16, 2004, which is the priority date on which U.S. Patent No. 8,992,608
`
`(the “’608 patent”) relies. I also provide my opinion regarding the subject matter
`
`described and claimed in the ’608 patent. In particular, I have reviewed and analyzed
`
`claims 1-4 of the ’608 patent and concluded, for the reasons set forth below, that each
`
`of these claims are invalid as anticipated and obvious in view of the prior art.
`
`3.
`
`I understand that this Declaration supports Edwards’ Petition for the
`
`above-captioned inter partes review (“IPR”) of the ’608 patent.
`
`4.
`
`I reserve the right to supplement, change, clarify, or modify my
`
`opinions should additional information and/or documentation become available to me.
`
`I also reserve the right to submit a rebuttal declaration in response to any expert
`
`declaration(s) submitted on behalf of the owner of the ’608 patent, Boston Scientific
`
`Scimed, Inc.
`
`
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`B.
`
`Background and Qualifications
`
`5.
`
`A copy of my curriculum vitae including a list of my publications is
`
`attached hereto as Exhibit A.
`
`6.
`
`I am a retired Consultant Cardiologist. Until January of 2008, I was
`
`Head of Interventional Cardiology at the Queen Elizabeth Hospital, Birmingham and
`
`the Lead Clinician for the Cardiac Catheterization Laboratories. The Cardiology
`
`Department at the Queen Elizabeth is one of the leading cardiology departments in the
`
`UK and one of only five centers in the UK that provides fully comprehensive adult
`
`cardiological services including interventional cardiology, electrophysiology, grown-
`
`up congenital heart disease and heart transplantation. I have conducted or directly
`
`supervised more than 8000 diagnostic and therapeutic non-surgical catheterization
`
`procedures since I was first appointed to a National Health Service consultant post in
`
`1990.
`
`7.
`
`During my medical training, I was awarded The John Mellanby
`
`Scholarship to fund an Intercalated Bachelor of Science degree. In 1977, I received a
`
`BSc (First Class Honours) in Physiology from the University of London. Modules
`
`included muscle physiology and biophysics at University College London (UCL), for
`
`which my tutor was the late Professor Andrew Huxley FRS, and neurophysiology at
`
`the Sherrington School of Physiology, for which my tutor was Professor John
`
`Stephens.
`
`
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`8.
`
`Following my degree, I was awarded an MRC Training Fellowship
`
`to continue my research at UCL and submit a PhD thesis. However, I declined the
`
`offer and continued my clinical medical training. Nevertheless, during the three years
`
`of undergraduate clinical training I continued my research work in my spare time and,
`
`before qualifying in medicine, I had published some of the results of my research in
`
`both Nature and The Journal of Physiology. In 1980, I was awarded MB BS by St.
`
`Thomas’s Hospital Medical School, University of London. In 1983, I became a
`
`member and, in 1996, I was elected a Fellow of the Royal College of Physicians in
`
`London.
`
`9.
`
`I have held a number of positions within highly regarded cardiology
`
`departments in the UK.
`
`10. From 1995 to 2010, I was Honoree Senior Lecturer in
`
`cardiovascular medicine at the University of Birmingham (UK).
`
`11. From 1995 to 2008, I was employed full time at Queen Elizabeth
`
`Hospital, Birmingham.
`
`12. From 1991 to 1995, I was Senior Lecturer in the Department of
`
`Interventional Cardiology and Cardiac Medicine at the National Heart and Lung
`
`Institute in London, and Honorary Consultant Cardiologist at the Royal Brompton
`
`National Heart and Lung Hospital.
`
`
`
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`13. Before that, I was a Senior Registrar in Cardiology at Harefield
`
`Hospital, Middlesex, and the Royal Free Hospital, London and prior to that a Registrar
`
`at the National Heart Hospital, London.
`
`14. From 1984 to 1986, I worked for Smith Kline & French Research
`
`Ltd, Philadelphia, USA, as a Research Physician and then as a project Chairman in
`
`Cardiovascular Drug Development.
`
`15. My first formal postgraduate training in cardiology was at St.
`
`Thomas’s Hospital and The Middlesex Hospital in 1981 and 1982, respectively.
`
`16. During my years as a junior doctor I trained in all aspects of
`
`cardiology but my interest developed in cardiac catheterization and non-surgical
`
`interventional cardiology. My mentor was the late Dr. Anthony Rickards who had
`
`performed the first successful coronary artery angioplasty in the UK in 1980. By 1990,
`
`I was considered fully trained in catheterization techniques and interventional
`
`cardiology including angioplasty and valvuloplasty.
`
`17.
`
`In 1990, I was appointed to and, in March 1991, I took up the
`
`position of Senior Lecturer in Interventional Cardiology at the National Heart and
`
`Lung Institute in London and was the third consultant interventional cardiologist to
`
`join Dr. Anthony Rickards and Dr. Ulrich Sigwart at the Royal Brompton National
`
`Heart and Lung Hospital, London.
`
`18.
`
`I have routinely assessed and investigated patients suffering from
`
`valvular heart disease. Such investigations typically include electrocardiogram (ECG),
`
`
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`chest X-ray (CXR) and echocardiography (a sonar examination to obtain detailed
`
`anatomical images and functional assessment of the heart and heart valves). These
`
`three tests are non-invasive and typically provide confirmation of the clinical diagnosis
`
`and allow selection of those patients that require further invasive investigation by
`
`means of diagnostic catheterization of the heart (passing flexible tubes through the
`
`veins and/or arteries and into the chambers of the heart) for hemodynamic (pressure
`
`and flow) measurements and angiography (injection of a radiopaque contrast media
`
`into the chambers and blood vessels of the heart so as further to document detailed
`
`anatomical and functional information on X-ray imaging). With this information it is
`
`then usually possible to determine the cause, the severity and the options for treatment
`
`of a patients’ heart valve disease.
`
`19. My research interests have included the prevention, diagnosis and
`
`treatment of heart disease and the development and clinical application of stents and
`
`especially coronary artery stents. I have been an investigator for many national and
`
`international scientific clinical trials.
`
`20. My earliest “hands on” clinical involvement with stent implantation
`
`was in 1987 when working with the late Dr. Anthony Rickards when I assisted him
`
`with the first insertions of stents into human coronary arteries in the UK. Stents were
`
`difficult to obtain at the time and initially were only for use in situations of acute or
`
`threatened closure after balloon angioplasty. This early work was experimental in
`
`nature. I have since conducted large numbers of stenting implantation procedures with
`
`
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`stents made by many different manufacturers. During 1991 to 1993, I was an
`
`investigator for the Benestent Trial (the major international multicenter “proof of
`
`concept” trial designed to demonstrate the benefit of elective stent placement over
`
`simple balloon angioplasty in the treatment of coronary artery disease), the results of
`
`which were subsequently published in the New England Journal of Medicine in 1994.
`
`21.
`
`In 1993, Ulrich Sigwart and I were the co-investigators for the
`
`“First-in-Man” study of Guidant Corporation’s “Multilink Stent” that subsequently
`
`became the long standing market leader for bare metal stents.
`
`22.
`
`In 1994, I implanted the first drug coated stent in a patient in the
`
`UK. In the same year I was approved by the U.S. Food and Drug Administration
`
`(FDA) to act as a proctor to supervise and oversee the first elective implantations of
`
`coronary artery stents in the U.S. (an FDA requirement) following the FDA approval
`
`of the Johnson & Johnson Palmaz-Schatz coronary artery stent. In this latter role I
`
`worked at more than fifty of the leading U.S. cardiology departments.
`
`23.
`
`I have also been involved in research and development work
`
`directed at stent graft technology. For example, in the late 1980s, I worked with
`
`Medinvent in Switzerland on the concept of a covered Wallstent. In the early 1990s,
`
`my work with Johnson and Johnson also included input into the Palmaz Stent Graft
`
`technology. Between 1992 and 1998, I was a paid member of the SCIMED Advisory
`
`Board that discussed and debated concepts and development ideas directly with
`
`
`
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`SCIMED engineers. During my tenure on the Advisory Board, SCIMED was acquired
`
`by Boston Scientific.
`
`24. Between 1987 and 1993 I only implanted bare metal stents. By
`
`1994, I had implanted one of the first fully polymer coated stents (Palmaz Hepacoat).
`
`Several years later, I implanted a very early coronary artery stent graft named JoStent.
`
`In the late 1990s and early 2000s, together with surgical colleagues and interventional
`
`radiologists, I implanted stent grafts, primarily in the aorta but also in iliac arteries. In
`
`the aorta, my main interest was the thoracic aorta and the treatment of aneurysms and
`
`dissections in this blood vessel.
`
`25.
`
`In 2013, I received hands-on training on the use and implantation of
`
`transcatheter heart valve (“THV”) technology at the New York Presbyterian Hospital.
`
`26. Throughout my career I have had a close working relationship with
`
`the research and development departments in the medical device and pharmaceutical
`
`industries. I have served on the advisory boards for many of the major medical device
`
`manufacturers, including SCIMED, Boston Scientific, Medtronic, Cordis and
`
`Guidant/Abbott.
`
`II. LEGAL STANDARDS
`
`A. Anticipation
`
`27.
`
`I am informed that a patent claim is anticipated if a single prior art
`
`reference discloses every element of the claim.
`
`
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`B. Obviousness
`
`28.
`
`I am informed that an obviousness analysis involves a number of
`
`considerations. I am informed that the scope and content of the prior art must be
`
`determined, as well as the level of ordinary skill in the art. I am further informed that a
`
`patent claim was obvious at the time of the invention if the differences between the
`
`subject matter sought to be patented and the prior art are such that the subject matter as
`
`a whole would have been obvious to a person having ordinary skill in the art. I am
`
`further informed that the focus when making a determination of obviousness should be
`
`on what a hypothetical person of ordinary skill in the pertinent art would have known
`
`at the time of the invention, and on what such a person would have reasonably
`
`expected to have been able to do in view of that knowledge. I am further informed that
`
`the following rationales may be considered when determining whether a claimed
`
`invention is obvious:
`
`(a) Combining prior art elements according to known methods to yield
`
`predictable results;
`
`(b)
`
`Simple substitution of one known element for another to obtain
`
`predictable results;
`
`(c) Use of known techniques to improve similar devices (methods, or
`
`products) in the same way;
`
`(d) Applying a known technique to a known device (method, or
`
`product) ready for improvement to yield predictable results;
`
`
`
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`(e)
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`“Obvious to try” – choosing from a finite number of identified,
`
`predictable solutions, with a reasonable expectation of success;
`
`(f) Known work in one field of endeavor may prompt variations of it
`
`for use in either the same field or a different one based on design
`
`incentives or other market forces if the variations would have been
`
`predictable to one of ordinary skill in the art; and
`
`(g)
`
`Some teaching, suggestion, or motivation in the prior art that would
`
`have led one of ordinary skill to modify the prior art reference or to
`
`combine prior art reference teachings to arrive at the claimed invention.
`
`29.
`
`I am informed that when determining whether there is an apparent
`
`reason to combine known elements in the way a patent claims, it will often be
`
`necessary to look to interrelated teachings of multiple patents, to the effects of
`
`demands known to the design community or present in the marketplace, and to the
`
`background knowledge possessed by a person having ordinary skill in the art.
`
`30.
`
`I am informed that when considering obviousness of a combination
`
`of known elements, the operative question is whether the improvement is more than
`
`the predictable use of prior art elements according to their established functions.
`
`31. The “teaching, suggestion, or motivation” test is a useful guide in
`
`establishing a rationale for combining elements of the prior art. This test poses the
`
`question as to whether there is an explicit teaching, suggestion, or motivation in the
`
`prior art to combine prior art elements in a way that realizes the claimed invention.
`
`
`
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`Though useful to the obviousness inquiry, I understand that this test should not be
`
`treated as a rigid rule. It is not necessary to seek out precise teachings; it is permissible
`
`to consider the inferences and creative steps that a person of ordinary skill in the art
`
`would employ.
`
`32.
`
`I am also informed that obviousness may be determined by looking
`
`at historical, objective evidence. Therefore, I am informed that certain historical
`
`evidence, such as commercial success of the patented invention, a long felt but
`
`unsolved need for the patented invention, failure of others to make the patented
`
`invention, skepticism about the claimed invention by experts, praise of the invention
`
`by others, and/or copying by others, may show that an invention was not obvious at the
`
`time the invention was made. I am informed that these categories of objective indicia
`
`are referred to as “secondary considerations.”
`
`33.
`
`I am also informed that an obviousness determination must be
`
`based on what was known at the time of the invention, that it is impermissible to use
`
`hindsight, and that it is improper to focus on just a part or element of the invention, as
`
`opposed to the invention as a whole.
`
`III. ORDINARY SKILL IN THE ART
`
`34.
`
`I am informed that the priority date for the ’608 patent is June 16,
`
`2004. The ’608 patent, which was filed on June 26, 2009, is a divisional of U.S. patent
`
`application 12/269,213, filed on November 12, 2008, which is a continuation of U.S.
`
`patent application 10/870,340, filed on June 16, 2004.
`
`
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`35.
`
`I am informed that the person of ordinary skill in the art is a
`
`hypothetical person who is presumed to have known the relevant art at the time of the
`
`invention. This is a person of ordinary creativity, not an automaton.
`
`36.
`
`It is my opinion that a person of ordinary skill in the art as of the
`
`priority date of the ’608 patent would have been an interventional cardiologist with a
`
`working knowledge of heart valve designs and endovascular prostheses, including
`
`expandable stents and stent-grafts. This person of ordinary skill in the art would,
`
`where necessary, work as a team in combination with a medical device engineer to
`
`experiment with or manufacture a device as claimed in the ’608 patent.
`
`IV. BACKGROUND OF THE RELEVANT TECHNOLOGY
`
`A.
`
`Surgical Prosthetic Heart Valves
`
`37.
`
` Petitioner Edwards was founded by Miles “Lowell” Edwards in
`
`1958. Edwards’ earliest work related to prosthetic heart valves that could be implanted
`
`surgically. Implantation of these devices involved an invasive procedure that required
`
`use of a heart-lung machine. In order to surgically implant a prosthetic heart valve, a
`
`surgeon opens a patient’s chest and the patient is connected to a heart-lung bypass
`
`machine, after which the heart can be arrested. The surgeon then surgically removes
`
`the diseased native valve and sutures the prosthetic valve in place. A diagram detailing
`
`the operation of a heart-lung machine is pictured below:
`
`
`
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`
`
`Available at http://www.daviddarling.info/encyclopedia/H/heart_surgery.html. This
`
`same procedure is used today for patients receiving a surgically implantable prosthetic
`
`
`
`heart valve.
`
`38. One of Edwards’ first commercially available surgical valves was a
`
`ball and cage valve called the Starr-Edwards valve. U.S. Patent No. 3,365,728 (the
`
`“’728 patent”), which issued on January 30, 1968, details the features of this valve.
`
`See Ex. 1011, ’728 patent. Notably, even this early valve prosthesis included a
`
`circumferentially oriented sewing ring that was adapted to extend into spaces in the
`
`tissue surrounding the implanted prosthesis to prevent leakage between the prosthetic
`
`valve and the surrounding tissue (i.e., “paravalvular leak”):
`
`Connected to the periphery of the valve ring is a suturable sewing ring [12]
`
`by which the valve may be connected by sutures with living tissue around
`
`
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`the natural orifice in which the valve is implanted. The sewing ring is
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`upholstered with a ring of compressible cushion material which will
`
`conform to irregularities in the bed in which the valve is placed whereby a
`
`good seal is established and leakage between the valve and the tissue is
`
`prevented.
`
`
`
`
`
`Id. at 1:38-46 and 3:12-20 (“The rubber cushion ring 35 conforms to any irregularities
`
`of tissue contour which may exist because of disease or other causes and forms an
`
`effective seal against the tissue. The layer of cloth 20 overlying the flange 36 provides
`
`an effective medium for the ingrowth of tissue over the whole surface of the sewing
`
`ring . . . .”), Figs. 1, 3 (highlighting added). Thus, paravalvular leak was a well-
`
`recognized complication of surgical valve replacement as early as the 1960s.
`
`39.
`
`In addition to ball and cage valves, Edwards also developed
`
`surgically implantable valves with biological valve leaflets. The biological valve
`
`structure could be made with a whole excised valve or formed with pericardial tissue,
`
`primarily of bovine or porcine origin. Edwards’ Perimount valve, for example, was
`
`
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`first introduced in 1980 and included a tri-leaflet bovine pericardial valve and a frame
`
`having a fabric sewing ring akin to the Starr-Edwards valve:
`
`Available at http://www.yourheartvalve.com/productinformation/
`
`
`
`pages/aorticvalvepericardial.aspx.
`
`B.
`
`Evolution of Stent Technology
`
`40. The term “stent” was originally used in the nineteenth century in
`
`reference to a medical resin used in dentistry (named after the dentist, Dr. Charles
`
`Stent). In the 20th century its meaning broadened to include devices used as
`
`scaffolding during conventional surgery.
`
`41. The concept of vascular stenting is attributed to Charles Dotter. In
`
`1969, he published his work concerning the implantation of stainless steel coils into the
`
`peripheral arteries of dogs.
`
`Dotter 1969 Stent
`
`
`
`
`
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`
`
`See Ex. 1012, Charles T. Dotter, “Transluminally-Placed Coilspring Endarterial Tube
`
`Grafts,” Investigative Radiology, pp. 329-332 (1969).
`
`42.
`
`In the same publication, Dotter also described a design for a self-
`
`expanding stent using spring force to provide expansion along the entire length of the
`
`stent thereby allowing the size of the remote arterial access to be significantly smaller
`
`than the diameter of the treated segment of artery. Subsequently many designs of self-
`
`expanding stents were developed. Notable among these were the Dotter thermal stent,
`
`the Z stent, and the Wallstent.
`
`43. The Charles Dotter thermal stent, disclosed in a 1983 article but
`
`never commercialized, is a thermal-memory metal self-expanding stent made of
`
`Nitinol alloy.
`
`
`
`Dotter Thermal Stent
`
`44. The Cesare Gianturco “Z” stent, which was first used in patients in
`
`the mid-1980s, is a self-expanding spring zig-zag structure.
`
`
`
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`
`
`Double ‘Z’ Stent with Connecting Wire
`
`
`
`45. The Hans Wallsten stent was commercialized in 1988 by the Swiss
`
`company Medinvent. The device, known as the “Wallstent,” was the first self-
`
`expanding stent to be implanted by a non-surgical catheterization technique in a human
`
`coronary artery. That first implant was performed by Jacques Puel working in
`
`Toulouse in March 1986. It was this stent that was implanted in patients in London the
`
`following year by Dr. Rickards and myself. Like the anchor structure disclosed in the
`
`’608 patent (see Ex. 1001 at 5:45-50, Figs. 32-33), the Wallstent is made with a
`
`collapsible and expandable braided-wire structure:
`
`
`
`Wallstent
`
`
`
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`Self-expanding stents are implanted such that their deployed diameter is less than their
`
`fully expanded, unconstrained diameter. This enables the stent to exert a radial force
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`onto the vessel wall to ensure adequate anchoring.
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`46.
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`In the field of non-surgical stents for use by interventional
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`cardiologists in the treatment of coronary artery disease, the seminal invention was by
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`Julio Palmaz, that of the plastically deformable, “balloon expandable stent.”
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`Developed in the early 1980s, and commercialized in the late 1980s, the commercial
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`Palmaz stent was a continuous stainless steel tube, which had a rectangular slot
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`configuration when manufactured and a diamond cell structure upon expansion.
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`Plastically deformable stents are known to recoil in diameter upon balloon deflation,
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`and are thus expanded to a diameter that allows the stent to remain anchored in place
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`even after recoil.
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`
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`Palmaz Stent
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`C.
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`Stent Foreshortening
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`47. Foreshortening is a known property for both self-expanding and
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`balloon-expandable stents. Foreshortening means that the length of the stent decreases
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`when expanding the stent from its collapsed, delivery configuration to its expanded,
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`implanted configuration. The degree of foreshortening is dependent on the stent
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`design.
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`48. Foreshortening is a measure of the percentage decrease in the
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`length of the stent from its collapsed, delivery configuration to its expanded, implanted
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`configuration. Thus, foreshortening is calculated as follows:
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`Foreshortening % = (change in length / length of collapsed stent) x 100
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`49. Before June 16, 2004, it was well known that stents could be
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`designed to foreshorten, not foreshorten at all, or lengthen upon radial expansion.
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`50. For example, a design of a commercial Wallstent has been shown to
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`foreshorten by 53%:
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`Ex. 1013, Frank Ing, “Stents: What’s Available to the Pediatric Interventional
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`Cardiologist?” Catheterization and Cardiovascular Interventions 57:274-386 (2002).
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`51. THVs, discussed infra, have also used stent designs that
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`foreshorten. See, e.g., WO 98/29057 to Cribier et al. (“Cribier”, Ex. 1003) at 16:11-16
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`(disclosing a stent with an expanded length of 10mm and a collapsed length of 20 mm
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`(i.e., 50% foreshortening)).
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`D.
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`Stent Grafts and Use of Fabric Covering to Prevent Endoleaks
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`52.
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`In the 1980s, it was generally recognized that stents could be used
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`to carry, implant, and anchor other materials. For example, stents were developed with
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`a covering (now called stent grafts). By virtue of the covering, stent grafts can be used
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`to isolate the wall of a blood vessel from the lumen of that vessel, as for instance to
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`reinforce a weakened blood vessel, to prevent leakage between the stent and vessel, or
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`to prevent exposure of a metallic stent to the surrounding tissue.
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`53. Soon after the pioneering stent work of Charles Dotter, Anatoly
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`Kononov, a Russian vascular surgeon, contemplated treating aortic aneurysm and
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`atherosclerotic stenosis using intravascular techniques. In 1973, Kononov performed a
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`series of canine studies in which he implanted stent grafts in the aorta. These stent
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`grafts had a pleated covering, as pictured below:
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`See Ex. 1015, excerpts from Vossoughi et al., Stent Graft Update (2000).
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`54.
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`In 1985, a Ukranian surgeon named Nicholas Volodos from the
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`same institution as Kononov, modified the stent graft to include a self-expanding stent
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`structure covered with a Dacron fabric. Volodos became the first to place an
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`endovascular graft transluminally to treat a patient with iliac artery occlusive disease.
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`Id.
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`55.
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`In 1990, Huan Parodi and Julio Palmaz implanted a plastically
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`deformable stent graft to treat an abdominal aortic aneurysm. Id. Following this work,
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`stent graft technology began to attract widespread interest in the field. Id.
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`56. Two commercial embodiments of stent grafts that were available in
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`the 1990s are pictured below:
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`
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`Ex. 1016, excerpts from Dolmatch et al., Stent Grafts: Current Clinical Practice
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`(1999) (EVT Endograft pictured on left; Talent Endoprosthesis pictured on right). As
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`shown in each of these examples, the fabric covers have excess material with wrinkles
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`in the graft’s expanded state.
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`57. Also shown on the lower end of the EVT Endograft pictured above
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`(left) is the well-known use of pre-formed circumferentially oriented pleats in the graft
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`material. This pre-formed, corrugated structure permits the endograft to extend and
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`increase its length in the longitudinal direction, akin to an accordion. As discussed
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`infra, Section VII, these well-known circumferentially oriented pleats in the graft
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`material were recognized by the Patent Office as “flaps” and “pockets” as claimed by
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`the ’608 patent, which the patent applicants did not dispute. I agree with the Patent
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`Office’s assessment.
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`58. Specifically, during examination of the ’608 patent the examiner
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`concluded that “[a]n implantable fabric having pleats and pockets is well known in the
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`art, as taught by De Paulis in Figure 2” and that it would have been obvious to modify
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`a sealing structure “to include pleats as an obvious alternative design choice.” Ex.
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`1002 (’608 patent File History), 4/10/14 Non-Final Rejection at 2-3. Figure 2 of U.S.
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`Patent No. 6,352,554 to De Paulis (“De Paulis,” Ex. 1021) appears below:
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`Ex. 1021, Fig. 2. The aortic grafts detailed by De Paulis are preferably made with
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`Dacron, and include “circumferentially extending pleats” or “corrugations” that
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`surround the conduit and “provide a degree of expansion in the longitudinal direction,”
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`thereby allowing the graft to “significantly increase its length.” See Ex. 1021 at 4:52-
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`5:8; Figs. 1-2. The grafts may also include “longitudinally extending pleats or
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`corrugations,” which allow the conduit to “expand in a lateral direction.” Id. at 5:1-33.
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`Moreover, “[t]he conduit … may be further provided with a prosthetic valve.” Id. at
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`3:51-52.
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`59. Similar to the risk of paravalvular leaks identified by surgical heart
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`valve designers, stent designers and physicians also recognized the risk of blood
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`leaking between the stent graft prosthesis and the surrounding tissue (i.e., “endoleaks”)
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`when a stent graft is used to treat an aneurysm. Aiding in the prevention of such
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`endoleaks is the selection of fabric that can conform to the surrounding tissue, as
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`pictured