UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`EDWARDS LIFESCIENCES CORPORATION AND
`EDWARDS LIFESCIENCES LLC
`
`Petitioners
`
`v.
`
`COLIBRI HEART VALVE LLC
`Patent Owner
`
`Case IPR2020-01649
`Patent No. 9,125,739
`
`DECLARATION OF STEVEN L. GOLDBERG, M.D.
`SUBMITTED ON BEHALF OF PETITIONERS EDWARDS LIFESCIENCES
`CORPORATION AND EDWARDS LIFESCIENCES LLC
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 1 of 147
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ................................................................................................. 1
`I.
`BACKGROUND AND QUALIFICATIONS ............................................................... 1
`II.
`III. PRIORITY DATE AND ONE OF SKILL IN THE ART ............................................... 6
`IV. BACKGROUND AND STATE OF THE ART ............................................................ 7
`V.
`SUMMARY OF THE ’739 PATENT ..................................................................... 29
`A. Overview of the ’739 Patent ................................................................ 29
`B.
`Claims of the ’739 Patent .................................................................... 36
`C. Overview of the Prosecution History of the ’739 Patent .................... 38
`D.
`Claim Construction of the ’739 Patent’s Claims ................................ 48
`VI. THE CHALLENGED CLAIMS ARE INVALID ....................................................... 54
`A.
`Legal Standards ................................................................................... 54
`1.
`Anticipation ............................................................................... 54
`2.
`Obviousness .............................................................................. 54
`3. Written Description ................................................................... 57
`B. Ground 1: Paniagua Anticipates Claims 1-5 of the ’739 Patent ........ 58
`1.
`Claim 1 Preamble: An assembly to treat a native heart
`valve in a patient, the assembly for use in combination
`with a guidewire, the assembly comprising .............................. 61
`Element 1[a]: a prosthetic heart valve including: a stent
`member having an inner channel, the stent member
`collapsible, expandable and configured for transluminal
`percutaneous delivery ............................................................... 61
`Element 1[b]: wherein the stent member include a
`tubular structure away from a central portion that flares at
`both ends in a trumpet-like configuration; and ......................... 62
`Element 1[c]: a valve means including two to four
`individual leaflets made of fixed pericardial tissue .................. 62
`Element 1[d]: wherein the valve means resides entirely
`within the inner channel of the stent member, and ................... 63
`
`2.
`
`3.
`
`4.
`
`5.
`
`i
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 2 of 147
`
`

`

`8.
`
`9.
`
`7.
`
`6.
`
`Element 1[e]: wherein no reinforcing members reside
`within the inner channel of the stent member ........................... 64
`Element 1[f]: a delivery system including a pusher
`member and a moveable sheath ................................................ 64
`Element 1[g]: the pusher member including a guidewire
`lumen ......................................................................................... 64
`Element 1[h]: wherein the pusher member is disposed
`within a lumen of the moveable sheath .................................... 64
`10. Element 1[i]: wherein the prosthetic heart valve is
`collapsed onto the pusher member to reside in a collapsed
`configuration on the pusher member and is restrained in
`the collapsed configuration by the moveable sheath ................ 65
`11. Element 1[j]: wherein a distal end of the prosthetic heart
`valve is located at a distal end of the moveable sheath,
`and ............................................................................................. 65
`12. Element 1[k]: wherein the valve means resides entirely
`within the inner channel of the stent member in said
`collapsed configuration and is configured to continue to
`reside entirely within the inner channel of the stent
`member upon deployment in the patient................................... 65
`13. Claim 2: The assembly of claim 1, wherein the stent
`member is self-expanding. ........................................................ 66
`14. Claim 3: The assembly of claim 2, wherein the stent
`member comprises nitinol. ........................................................ 66
`15. Claim 4: The assembly of claim 1, wherein the stent
`member includes two circles of barbs on an outer surface
`of the stent member. .................................................................. 66
`16. Claim 5: The assembly of claim 1, wherein the pusher
`member includes a controlled release mechanism that can
`be activated. .............................................................................. 66
`C. Grounds 2 & 3: Bessler (Ex. 1006) in View of Teitelbaum (Ex.
`1007) (Ground 2); or, in the Alternative, Bessler (Ex. 1006) in
`View of Leonhardt (Ex. 1012) (Ground 3), Renders Obvious
`Claims 1-5 of the ’739 Patent .............................................................. 66
`
`ii
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 3 of 147
`
`

`

`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`1.
`
`Claim 1 Preamble: An assembly to treat a native heart
`valve in a patient, the assembly for use in combination
`with a guidewire, the assembly comprising .............................. 67
`Element 1[a]: a prosthetic heart valve including: a stent
`member having an inner channel, the stent member
`collapsible, expandable and configured for transluminal
`percutaneous delivery ............................................................... 68
`Element 1[b]: wherein the stent member includes a
`tubular structure away from a central portion that flares at
`both ends in a trumpet-like configuration; and ......................... 69
`Element 1[c]: a valve means including two to four
`individual leaflets made of fixed pericardial tissue .................. 74
`Element 1[d]: wherein the valve means resides entirely
`within the inner channel of the stent member, and ................... 75
`Element 1[e]: wherein no reinforcing members reside
`within the inner channel of the stent member ........................... 77
`Element 1[f]: a delivery system including a pusher
`member and a moveable sheath ................................................ 78
`Element 1[g]: the pusher member including a guidewire
`lumen ......................................................................................... 80
`Element 1[h]: wherein the pusher member is disposed
`within a lumen of the moveable sheath .................................... 80
`10. Element 1[i]: wherein the prosthetic heart valve is
`collapsed onto the pusher member to reside in a collapsed
`configuration on the pusher member and is restrained in
`the collapsed configuration by the moveable sheath ................ 81
`11. Element 1[j]: wherein a distal end of the prosthetic heart
`valve is located at a distal end of the moveable sheath,
`and ............................................................................................. 86
`12. Element 1[k]: wherein the valve means resides entirely
`within the inner channel of the stent member in said
`collapsed configuration and is configured to continue to
`reside entirely within the inner channel of the stent
`member upon deployment in the patient................................... 87
`
`7.
`
`8.
`
`9.
`
`iii
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 4 of 147
`
`

`

`13. Claim 2: The assembly of claim 1, wherein the stent
`member is self-expanding. ........................................................ 88
`14. Claim 3: The assembly of claim 2, wherein the stent
`member comprises nitinol. ........................................................ 88
`15. Claim 4: The assembly of claim 1, wherein the stent
`member includes two circles of barbs on an outer surface
`of the stent member. .................................................................. 89
`16. Claim 5: The assembly of claim 1, wherein the pusher
`member includes a controlled release mechanism that can
`be activated. .............................................................................. 90
`D. Grounds 4 & 5: Bessler (Ex. 1006) in View of Teitelbaum (Ex.
`1007) + Klint (Ex. 1019) (Ground 4); or, in the Alternative,
`Bessler (Ex. 1006) in View of Leonhardt (Ex. 1012) + Klint
`(Ex. 1019) (Ground 5), Renders Obvious Claims 1-5 of the
`’739 Patent ........................................................................................... 91
`VII. OBJECTIVE INDICIA OF NON-OBVIOUSNESS .................................................... 94
`VIII. CONCLUSION ................................................................................................... 95
`
`iv
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 5 of 147
`
`

`

`I, Steven L. Goldberg, M.D., declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`I have been retained on behalf of Edwards Lifesciences Corporation
`
`and Edwards Lifesciences LLC (“Edwards”) to provide my opinion on the state of
`
`percutaneous replacement heart valve devices and delivery system technology and
`
`the scope and content of certain “prior art” patents and printed publications
`
`predating January 4, 2002, which I understand is the priority date on which U.S.
`
`Patent No. 9,125,739 (the “’739 Patent”) relies. I also provide my opinion
`
`regarding the subject matter described and claimed in the ’739 Patent. In
`
`particular, I have reviewed and analyzed claims 1-5 of the ’739 Patent and
`
`concluded, for the reasons set forth below, that each of these claims are invalid as
`
`anticipated and/or obvious in view of the prior art.
`
`2.
`
`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 ’739 Patent, Colibri
`
`Heart Valve LLC.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`3.
`
`A copy of my curriculum vitae, including a list of my publications, is
`
`attached hereto as Exhibit A.
`
`1
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 6 of 147
`
`

`

`4.
`
`I am a practicing Interventional Cardiologist with over 35 years of
`
`clinical experience. Since April 2017, I have been the Medical Director for
`
`Structural Heart Disease at the Tyler Heart Institute, Community Hospital of the
`
`Monterey Peninsula.
`
`5.
`
`Since 2006, I have also acted as Chief Clinical Officer (2006-2014)
`
`and Chief Medical Officer (2014-present) of Cardiac Dimensions, Inc., a private
`
`medical device company that develops novel tools for the treatment of heart failure
`
`and related conditions.
`
`6.
`
`I am a Fellow of the American College of Cardiology and the Society
`
`of Cardiac Angiography and Intervention. I am a licensed physician in California,
`
`Washington, Montana, and Colorado, and hold American Board of Internal
`
`Medicine Certifications in Interventional Cardiology, Cardiovascular Disease, and
`
`Internal Medicine.
`
`7.
`
`I hold a Bachelor of Arts in Mathematics (1980) and an M.D. (1984)
`
`from the University of Kansas.
`
`8.
`
`Following medical school, from July 1984 until July 1988, I was an
`
`intern, resident, and then fellow in General Internal Medicine, with an emphasis on
`
`critical care, in the Department of Medicine at Cedars-Sinai Medical Center.
`
`9.
`
`I subsequently spent several months in 1989 working in internal
`
`medicine with the Indian Health Service on Rosebud Sioux Indian Reservation in
`
`2
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 7 of 147
`
`

`

`South Dakota before spending a year as a traveling clinician in various “third-
`
`world” settings, including Kenya, South Africa, India, Nepal, and Jamaica.
`
`10.
`
`From July 1990 through June 1993, I was a Fellow in Cardiology at
`
`the University of California, Irvine.
`
`11.
`
`From October 1993 through December 1998, I was an Associate
`
`Director at the Cardiac Catheterization Laboratory at Harbor-UCLA Medical
`
`Center.
`
`12.
`
`From January 1999 through June 2000, I was the Director of the
`
`Cardiac Catheterization Laboratory at the West Los Angeles VA Medical Center.
`
`13.
`
`I also served as an Assistant Professor of Medicine at UCLA from
`
`October 1993 through June 2000.
`
`14.
`
`I subsequently joined the University of Washington Medical Center
`
`where I was a practicing Interventional Cardiologist through 2015. While at the
`
`University of Washington, I was an Associate Professor of Medicine (2000-2006)
`
`and a Clinical Associate Professor of Medicine (2006-2014). From 2004 through
`
`2014, I was the director of the University of Washington Medical Center’s
`
`Catheterization Laboratory.
`
`15.
`
`From 2015 through 2016, I was an Interventional Cardiologist in the
`
`Rocky Mountain Heart and Lung division of the Kalispell Regional Medical
`
`Center in Montana.
`
`3
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 8 of 147
`
`

`

`16.
`
`I am currently on the editorial board of two journals, the Journal of
`
`Invasive Cardiology, which I have served on since 1999, and Cardiac
`
`Revascularization Medicine, which I have served on since 2017. I am also a
`
`reviewer for the American Heart Journal, the American Journal of Cardiology,
`
`Biomacromolecules, Circulation, Catheterization and Cardiac Interventions, Heart,
`
`the Journal of the American Medical Association, the Journal of the American
`
`College of Cardiology, the Journal of Interventional Cardiology, the Journal of
`
`Invasive Cardiology, Minerva Cardioangiologica, and
`
`the
`
`Journal of
`
`Transplantation.
`
`17.
`
`In the course of my career, I have also authored over 50 peer reviewed
`
`papers, several book chapters, and dozens of research abstracts, and given
`
`hundreds of lectures and presentations.
`
`18. During my career as an Interventional Cardiologist, I have implanted
`
`over 10,000 stents and performed hundreds of valvuloplasties of all heart valves.
`
`In the early 1990s, I was a clinical study proctor for some of the first-ever-FDA-
`
`approved stents, including the Palmaz-Schatz and Wiktor Stents.
`
`19. My interest in transcatheter valve technology stems back to the early
`
`1990s, when Dr. Henning Rud Andersen and his colleagues first reported the
`
`outcomes of a series of proof-of-concept animal studies involving the implantation
`
`4
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 9 of 147
`
`

`

`of transcatheter heart valves. This technology became a topic of conversation in
`
`faculty and industry meetings I attended in the years that followed.
`
`20.
`
`In 2000, a company named Percutaneous Valve Technologies
`
`(“PVT”), which was co-founded by Dr. Alain Cribier and three others (Stanton
`
`Rowe, Stan Rabinovich, and Dr. Martin Leon), commenced a transcatheter heart
`
`valve development program. I was contacted by Stanton Rowe (whom I had
`
`known through my earlier work with the Palmaz-Schatz stent) to assist PVT in its
`
`early research efforts, but I was unable to assist at that time. PVT’s development
`
`efforts culminated in the first ever implantation of a transcatheter aortic heart valve
`
`in a patient, which was performed by Dr. Cribier in April 2002. Transcatheter
`
`valve technology gained widespread interest after this landmark procedure.
`
`21.
`
`The first FDA-approved study on the implantation of transcatheter
`
`aortic heart valves was Edwards Lifesciences’ PARTNER study on its SAPIEN
`
`valve, which I participated in at the University of Washington Medical Center
`
`starting in 2009.
`
` The SAPIEN device became the first FDA-approved
`
`transcatheter aortic heart valve in 2011 (it was previously commercially approved
`
`in Europe in 2007).
`
`22.
`
`To date, I have implanted about 70 transcatheter heart valves in
`
`patients, including the Edwards SAPIEN valve and Medtronic’s CoreValve device
`
`5
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 10 of 147
`
`

`

`(which was also commercially approved in Europe in 2007 and FDA-approved in
`
`2014).
`
`23.
`
`I remain actively involved in the Tyler Heart Institute’s transcatheter
`
`valve program, which I started, and I am a vocal advocate for transcatheter valve
`
`technology. I have testified before the Centers for Medicare & Medicaid Services
`
`(“CMS”) about transcatheter valve technology and have authored letters, including
`
`to the Editor of the New England Journal of Medicine, about access to
`
`transcatheter-valve-related care in community hospitals.
`
`III. PRIORITY DATE AND ONE OF SKILL IN THE ART
`
`24.
`
`The ’739 Patent, which was filed on April 15, 2014, identifies on its
`
`face that it is a continuation of U.S. Patent Application No. 13/675,665, filed on
`
`November 13, 2012, which is a continuation of U.S. Patent Application No.
`
`10/887,688, filed on July 10, 2004, which is a continuation-in-part of U.S. Patent
`
`Application No. 10/037,266, filed on January 4, 2002.
`
`25.
`
`I am informed that there is a legal dispute as to whether the ’739
`
`Patent does in fact have an effective filing date of January 4, 2002, or if there is a
`
`lack of description such that the claims of the ’739 Patent are supported only by the
`
`claim amendments made during prosecution on April 15, 2014. Unless otherwise
`
`noted, my opinions and analysis set forth herein apply a January 4, 2002 priority
`
`date.
`
`6
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 11 of 147
`
`

`

`26.
`
`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.
`
`27.
`
`It is my opinion that a person of ordinary skill in the art as of January
`
`4, 2002, would have been an interventional cardiologist with a working knowledge
`
`of heart valve designs, expandable stents, and intravascular delivery systems for
`
`stents. 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 ’739 Patent. A person of ordinary skill in
`
`the art as of April 15, 2014 would have had the same credentials as above, but
`
`would have also had the knowledge of the additional advances in the art –
`
`including the development and approval of several commercial THVs – between
`
`2002 and 2014.
`
`IV. BACKGROUND AND STATE OF THE ART
`
`28.
`
`Transcatheter heart valve technology traces its roots to 1989 and the
`
`groundbreaking work of Danish doctor Henning Rud Andersen and his colleagues.
`
`That year, Dr. Andersen’s team conceived of and built prototypes of a permanently
`
`implantable collapsible and expandable heart valve that could be implanted via a
`
`catheter. This technology was premised on providing a minimally invasive
`
`alternative to surgical heart valve replacement procedures, which require the
`
`7
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 12 of 147
`
`

`

`extracorporeal circulation of a patient’s blood with a heart-lung bypass machine,
`
`opening a patient’s chest and surgically removing a patient’s diseased valve, and
`
`suturing into place a prosthetic valve.
`
`29. Dr. Andersen’s team successfully implanted their prototype in a
`
`number of pigs. Results were first published in 1992. Ex. 1003 (Andersen et al.),
`
`at 1-5. The prototyped device was described as “a foldable biological cardiac
`
`valve inside a balloon expandable metallic stent.” Id. at 1. Dr. Andersen’s team
`
`also patented their work, more broadly contemplating that their inventive
`
`prosthesis could be either balloon expandable or self-expanding, made with a
`
`variety of different stent structures, and made with a variety of different valve
`
`structures (“[i]nstead of a biological valve it might be possible to use other
`
`collapsible valves, such as valves made from synthetic materials, e.g.,
`
`polyurethane. It is also possible to use valves with more or fewer flaps than
`
`three.”). Ex. 1004 (U.S. Pat. No. 5,411,552) at 7:12-16; see also id. at 2:38-68,
`
`3:13-62.
`
`30.
`
`In 1994, a marquee textbook in the field – the Textbook of
`
`Interventional Cardiology – included a chapter written by Dr. Steven R. Bailey
`
`devoted to percutaneous expandable prosthetic valves. Ex. 1005 (Textbook of
`
`Interventional Cardiology, 2d Ed.), at 4-12. The text recognized Dr. Andersen’s
`
`work as “[t]he most exciting published work in this area to date,” and it was noted
`
`8
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 13 of 147
`
`

`

`that “[a]lthough the [Andersen] study presents only early data illustrating the large
`
`amount of work required before a device such as this can be used, it illustrates that
`
`such devices await only the focused evaluation and improvement of a few
`
`investigators.” Id. at 12. The text also noted that “[c]urrent mechanical and
`
`prosthetic valves suffer from a number of problems . . . including the
`
`predisposition to thrombus formation and embolization, perivalvular leak,
`
`infection, difficulty sizing valve to annulus, valve degeneration, and pannus
`
`formation. The designer of any percutaneously placed valve will need to consider
`
`these issues during its design and development in order to minimize these
`
`problems.” Id. at 7. Over the next several years, a number of transcatheter heart
`
`valve designs were conceptualized, studied, and publicized, and reported studies
`
`continued to support the viability of the technology. See, e.g., Ex. 1031
`
`(Bonhoeffer et al. reporting in 2000 first-in-human transcatheter pulmonary valve
`
`implant); Ex. 1032 (Pavcnik et al. reporting results in 2000 of transcatheter aortic
`
`and venous valve implants in animals).
`
`31.
`
`In my opinion, by January 4, 2002, all of the elements claimed in the
`
`’739 Patent were already well-known in the art. The specification of the ’739
`
`Patent itself supports this opinion, because it borrows heavily from prior art
`
`references. Indeed, in my review of the ’739 Patent and references in the prior art,
`
`I noticed that well over one hundred lines in the specification of the ’739 Patent
`
`9
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 14 of 147
`
`

`

`were identical or nearly identical to portions of the specification of U.S. Patent No.
`
`5,855,601 to Bessler (“Bessler”) (Ex. 1006), which issued in January 1999, and
`
`U.S. Patent No. 5,332,402 to Teitelbaum (“Teitelbaum”) (Ex. 1007), which issued
`
`in July 1994. Despite copying large portions of the specifications of Bessler and
`
`Teitelbaum, there is no mention of either prior art reference in the background
`
`discussion in the ’739 Patent. Ex. 1001 at 1:18-4:59; see generally id.
`
`32. Much of the description of the valve means and stent member, as well
`
`as the removal of the native valve and delivery and implantation system for the
`
`replacement artificial heart valve, is identical (or nearly so) to portions of Bessler.
`
`I have reproduced several examples of such passages side by side in the below
`
`table, with the identical portions in each bolded and italicized:
`
`’739 Patent
`
`Bessler (’601 Patent)
`
`“The
`
`configuration of
`
`the
`
`stent
`
`“The
`
`configuration of
`
`the
`
`stent
`
`member 100 and the flexible, resilient
`
`member 32 and the flexible, resilient
`
`material of construction allows the
`
`material of construction allows the
`
`valve to collapse into a relatively small
`
`valve to collapse into a relatively small
`
`cylinder as seen
`
`in FIG. 6. The
`
`cylinder 40 as seen in FIG. 5. The
`
`replacement heart valve will not stay in
`
`artificial heart valve will not stay in
`
`its collapsed configuration without
`
`its collapsed configuration without
`
`being restrained. Once the restraint is
`
`being restrained. Once the restraint is
`
`10
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 15 of 147
`
`

`

`’739 Patent
`
`Bessler (’601 Patent)
`
`removed,
`
`the
`
`self-expanding
`
`stent
`
`removed,
`
`the
`
`self-expanding
`
`stent
`
`member 100 will cause the artificial
`
`member 32 will cause the artificial
`
`heart valve
`
`to
`
`take
`
`its expanded
`
`heart valve
`
`to
`
`take
`
`its expanded
`
`configuration, as seen in FIG. 5.”
`
`configuration, as seen in FIG. 4.”
`
`Ex. 1001 at 7:18-7:25.
`
`Ex. 1006 at 5:44-51.
`
`“An enlarged view of a preferred
`
`“An enlarged view of a preferred
`
`embodiment of the stent member for
`
`embodiment of a stent member for
`
`use in the replacement heart valve of
`
`use in the artificial heart valve of
`
`the invention is depicted in FIG. 5. The
`
`the invention is depicted in FIG. 6. The
`
`stent member 100 includes a length of
`
`stent member 50 includes a length of
`
`wire 110 formed in a closed zigzag
`
`wire 51 formed in a closed zig-zag
`
`configuration. The wire can be a single
`
`configuration. The wire can be a single
`
`piece, stamped or extruded, or it could
`
`piece, stamped or extruded, or it could
`
`be formed by welding the free ends
`
`be formed by welding the free ends
`
`together. The straight sections
`
`together as at 52. The straight sections
`
`of the stent member 100 are joined by
`
`53 of the stent are joined by
`
`bends.
`
`bends 54.
`
`The stent is readily compressible
`
`The stent is readily compressible
`
`to a small cylindrical shape
`
`to a small cylindrical shape
`
`11
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 16 of 147
`
`

`

`’739 Patent
`
`Bessler (’601 Patent)
`
`as depicted in FIGS. 6 and 8,
`
`and resiliently self-expandable to the
`
`and resiliently self-expandable to the
`
`shape shown in FIG. 5.”
`
`shape shown in FIG. 6.”
`
`Ex. 1001 at 7:29-7:38.
`
`Ex. 1006 at 5:52-60.
`
`“The stent member 100 of the artificial
`
`“The stent members of the artificial
`
`heart valve device of
`
`the present
`
`heart valves of the present
`
`invention may be made from various
`
`invention may be made from Elgiloy
`
`metal alloys, titanium, titanium alloy,
`
`alloy, titanium, titanium alloy,
`
`nitinol,
`
`stainless
`
`steel, or other
`
`nitinol,
`
`stainless
`
`steel, or other
`
`resilient,
`
`flexible non-toxic, non-
`
`resilient,
`
`flexible non-toxic, non-
`
`thrombogenic,
`
`physiologically
`
`thrombogenic,
`
`physiologically
`
`acceptable
`
`and
`
`biocompatible
`
`acceptable
`
`and
`
`biocompatible
`
`materials. The configuration may be
`
`materials. The configuration may be
`
`the zigzag configuration shown or a
`
`the zig-zag configuration shown or a
`
`sine wave
`
`configuration, mesh
`
`sine wave
`
`configuration, mesh
`
`configuration
`
`or
`
`a
`
`similar
`
`configuration
`
`or
`
`a
`
`similar
`
`configuration which will allow the
`
`configuration which will allow the
`
`stent to be readily collapsible and self-
`
`stent to be readily collapsible and self-
`
`expandable. When a zigzag or sine
`
`expandable. When a zig-zag or sine
`
`12
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 17 of 147
`
`

`

`’739 Patent
`
`Bessler (’601 Patent)
`
`wave configured stent member is used,
`
`wave configured stent member is used,
`
`the diameter of the wire from which the
`
`the diameter of the wire from which the
`
`stent is made is preferably from about
`
`stent is made should be from about
`
`0.010
`
`to 0.035
`
`inches and
`
`still,
`
`0.010 to 0.035 inches,
`
`preferably from about 0.012 to 0.025
`
`preferably from about 0.012 to 0.025
`
`inches. The diameter of
`
`the stent
`
`inches. The diameter of
`
`the stent
`
`member will be from about 1.5 to 3.5
`
`member will be from about 1.5 to 3.5
`
`cm, preferably from about 1.75 to 3.00
`
`cm, preferably from about 1.75 to 3.00
`
`cm, and the length of the stent member
`
`cm, and the length of the stent member
`
`will be from about 1.0 to 10 cm,
`
`will be from about 1.0 to 10 cm,
`
`preferably from about 1.1 to 5 cm.”
`
`preferably from about 1.1 to 5 cm.”
`
`Ex. 1001 at 7:39-7:54.
`
`Ex. 1006 at 6:3-18.
`
`“Preferably
`
`the stent member 100
`
`“Preferably the stent member
`
`carries a plurality of barbs extending
`
`carries a plurality of barbs extending
`
`outwardly from the outside surface of
`
`outwardly from the outside surface of
`
`the stent member for fixing the heart
`
`the stent member for fixing the heart
`
`valve device in a desired position. More
`
`valve
`
`in a desired position. More
`
`preferably the barbs are disposed in
`
`preferably the barbs are disposed in
`
`two
`
`spaced-apart,
`
`circular
`
`two
`
`spaced-apart,
`
`circular
`
`13
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 18 of 147
`
`

`

`’739 Patent
`
`Bessler (’601 Patent)
`
`configurations with the barbs in one
`
`configurations with the barbs in one
`
`circle extending
`
`in an upstream
`
`circle extending
`
`in an upstream
`
`direction and the barbs in the other
`
`direction and the barbs in the other
`
`circle extending
`
`in a downstream
`
`circle extending
`
`in a downstream
`
`direction. It is especially preferable
`
`direction. It is especially preferable
`
`that the barbs on the inflow side of the
`
`that the barbs on the inflow side of the
`
`valve point in the direction of flow and
`
`valve point in the direction of flow and
`
`the barbs on the outflow side point in
`
`the barbs on the outflow side point in
`
`the direction opposite to flow. It is
`
`the direction opposite to flow. It is
`
`preferred that the stent be formed of
`
`preferred that the stent be formed of
`
`titanium alloy wire or other flexible,
`
`titanium alloy wire or other flexible,
`
`relatively
`
`rigid,
`
`physiologically
`
`relatively
`
`rigid,
`
`physiologically
`
`acceptable material arranged
`
`in a
`
`acceptable material arranged
`
`in a
`
`closed zigzag configuration so that the
`
`closed zig-zag configuration. Such a
`
`stent member will readily
`
`configured stent member will readily
`
`collapse and expand as pressure is
`
`collapse and expand as pressure is
`
`applied and released, respectively.”
`
`applied and released, respectively.”
`
`Ex. 1001 at 8:11-25.
`
`Ex. 1006 at 4:12-26.
`
`“The delivery and implantation system “The system for implanting the above
`
`14
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 19 of 147
`
`

`

`’739 Patent
`
`Bessler (’601 Patent)
`
`of the replacement artificial heart valve
`
`described artificial heart valve
`
`of the present invention
`
`percutaneously and
`
`transluminally
`
`percutaneously and
`
`transluminally
`
`includes a flexible catheter 400 which
`
`includes a flexible catheter which
`
`may be inserted into a vessel of the
`
`may be inserted into a vessel of the
`
`patient and moved within that vessel as
`
`patient and moved within that vessel.
`
`depicted in FIG. 8.
`
`The distal end 410 of the catheter 400,
`
`The distal end of the catheter,
`
`which
`
`is hollow and carries
`
`the
`
`which
`
`is hollow and carries
`
`the
`
`replacement heart valve device of the
`
`artificial heart valve of the
`
`present
`
`invention
`
`in
`
`its collapsed
`
`present
`
`invention
`
`in
`
`its collapsed
`
`configuration, is guided to a site where
`
`configuration, is guided to a site where
`
`it is desired to implant the replacement
`
`it is desired to implant the artificial
`
`heart valve. The catheter has a pusher
`
`heart valve. The catheter has a pusher
`
`member 420 disposed within
`
`the
`
`member disposed within the
`
`catheter lumen 430 and extending from
`
`catheter lumen and extending from
`
`the proximal end 440 of the catheter to
`
`the proximal end of the catheter to
`
`the hollow section at the distal end 410
`
`the hollow section at the distal end
`
`of the catheter. Once the distal end 410
`
`of the catheter. Once the distal end
`
`15
`
`Edwards Lifesciences Corporation, et al. Exhibit 1020, p. 20 of 147
`
`

`

`’739 Patent
`
`Bessler (’601 Patent)
`
`of the catheter is positioned as desired,
`
`of the catheter is positioned as desired,
`
`the pusher mechanism 420 is activated
`
`the pusher mechanism is activated
`
`and
`
`the distal portion of
`
`the
`
`and the distal portion of the
`
`replacement heart valve device
`
`is
`
`artificial heart valve is
`
`pushed out of the catheter and the stent
`
`pushed out of the catheter and the stent
`
`member 100 partially expands. In this
`
`member partially expands.
`
`In
`
`this
`
`position
`
`the stent member 100
`
`is
`
`position the stent member is
`
`restrained so that it doesn’t pop out
`
`restrained so that it doesn’t pop out
`
`and is held for controlled release, with
`
`and is held for controlled release, with
`
`the potential that the replacement heart
`
`the potential that the artificial heart
`
`valve device can be recovered if there is
`
`valve can be recovered if there is
`
`a problem with the posit