`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORPORATION,
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`
`
`Case IPR2017-01295
`Patent 8,709,062 B2
`_______________
`
`Before the Honorable JAMES A. TARTAL, ROBERT L. KINDER, and
`AMANDA F. WIEKER, Administrative Patent Judges.
`
`
`
`DECLARATION OF RONALD J. SOLAR, Ph.D.
`
`
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`Edwards Lifesciences v. Boston
`Scientific Scimed
`IPR 2017-01295 U.S. Pat. 8,709,062
`Exhibit 2004
`
`
`
`TABLE OF CONTENTS
`
`TABLE OF CONTENTS .......................................................................................... 1
`I.
`INTRODUCTION .............................................................................................. 1
`II. INFORMATION REVIEWED OR CONSIDERED ......................................... 5
`III. LEGAL STANDARDS ................................................................................... 5
`IV. THE LEVEL OF ORDINARY SKILL IN THE ART..................................... 9
`V. The ‘062 Patent................................................................................................. 10
`VI. THE SCOPE AND CONTENT OF THE PRIOR ART AND THE
`DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE PRIOR
`ART 13
`A. Rupp ............................................................................................................ 13
`1. Rupp Does Not Disclose The Requirement In Claim 7 ........................... 18
`B.
`Jendersee ..................................................................................................... 22
`C.
`Sugiyama .................................................................................................... 26
`VII. ONE OF ORDINARY SKILL IN THE ART WOULD NOT HAVE
`COMBINED RUPP WITH JENDERSEE TO DERIVE THE CLAIMS OF THE
`‘062 PATENT ......................................................................................................... 26
`A. One Of Ordinary Skill In The Art Would Not Have Selected Rupp For
`Modification To Solve The Problems Encountered By The Inventors Of The
`‘062 Patent ........................................................................................................... 27
`B. One Of Ordinary Skill In The Art Would Not Have Combined Rupp With
`Jendersee To Derive The Claimed Invention Of The ‘062 Patent ....................... 29
`
`
`
`- I -
`
`
`
`I, Ronald J. Solar, state and declare as follows:
`
`I.
`
`INTRODUCTION
`1.
`
`I am currently the President of Renaissance Biomedical, Inc., which
`
`performs research and consultation in technical, marketing, commercialization,
`
`patent, clinical, and regulatory issues related to the medical device industry. I am
`
`also currently the President and CEO of ThermopeutiX, Inc., a company which
`
`designs, develops, manufactures, and sells vascular catheter technology and
`
`devices, including coronary, peripheral and neuro-vascular catheters and related
`
`medical devices.
`
`2.
`
`I obtained a Bachelor of Science degree in Metallurgy and Materials
`
`Science from the Pennsylvania State University in 1972. My undergraduate thesis
`
`was entitled “Failure Analysis of Orthopaedic Implants.” I also received a Ph.D. in
`
`Materials Science and Biomaterials from the University of Pennsylvania in 1977.
`
`My doctoral dissertation was entitled “Corrosion Behavior of Surgical Implant
`
`Alloys.”
`
`3.
`
`I first began working in the balloon catheter field in 1980 when the
`
`field was in its infancy and with relatively few procedures using balloon catheters
`
`being performed worldwide. Over the next 30 plus years, I worked extensively in
`
`researching and developing coronary and peripheral vascular medical devices
`
`including balloon catheters and stents.
`
`- 1 -
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`
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`4.
`
`I subscribe to a number of medical journals and medical device
`
`industry journals. I attend medical conferences, courses, symposia and workshops,
`
`as well as trade shows sponsored for the medical device industry. I attend roughly
`
`eight to twelve of such events per year to continue and maintain my expertise and
`
`education in the medical device industry, including Transcatheter Cardiovascular
`
`Therapeutics (TCT), Leipzig Interventional Course (LINC), EuroPCR, New
`
`Cardiovascular Horizons (NCVH), Cardiovascular Revascularization Therapies
`
`(CRT), International Conference for Innovations in Cardiovascular Systems (ICI),
`
`and courses and annual meetings of the American College of Cardiology (ACC),
`
`the European Society of Cardiology (ESC) and the American Heart Association
`
`(AHA). I am currently a professional member of the Horizons International
`
`Peripheral Group (HIPG), the ESC, and the AHA.
`
`5.
`
`To date, I have obtained, as inventor or co-inventor, 58 United States
`
`patents and numerous foreign patents, all in the medical device area. Many of
`
`these patents relate to stents or stent applications:
`
`•
`
`•
`
`•
`
`U.S. Patent No. 5,403,341 filed in 1994 and entitled “Parallel Flow
`Endovascular Stent and Deployment Apparatus Therefore”
`
`U.S. Patent No. 5,407,432 filed in 1992 and entitled “Method of
`Positioning a Stent”
`
`U.S. Patent No. 5,549,635 filed in 1994 and entitled “Non-
`Deformable Self-Expanding Parallel Flow Endovascular Stent and
`Deployment Apparatus Therefore”
`
`- 2 -
`
`
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`U.S. Patent No. 5,669,880 filed in 1993 and entitled “Stent Delivery
`System”
`
`U.S. Patent No. 5,810,838 filed in 1997 and entitled “Hydraulic
`method and apparatus for uniform radial compression and catheter
`mounting of radially expandable intraluminal stents and stented
`grafts”
`
`U.S. Patent No. 6,004,328 filed in 1997 and entitled “Radially
`Expandable Intraluminal Stent and Delivery Catheter Therefore and
`Method of Using the Same”
`
`U.S. Patent No. 6,254,608 filed in 1997 and entitled “Sheathless
`Delivery Catheter for Radially Expandable Intraluminal Stents and
`Stented Grafts”
`
`U.S. Patent No. 6,447,501 filed in 1998 and entitled “Enhanced Stent
`Delivery System”
`
`U.S. Patent No. 9,254,208 filed in 2013 and entitled “Oblique Stent”
`
`Specifically, two of the U.S. patents I hold (Nos. 5,810,838 and 5,971,992)
`
`relate to methods and apparatuses for crimping a stent. Several other U.S. patents
`
`(such as No. 5,403,341) relate to stent securement issues.
`
`6.
`
`I am also the author or co-author of about 30 peer-reviewed articles in
`
`medical or scientific journals, 7 book chapters, and 54 presentations at scientific
`
`sessions of major medical meetings. Many of my articles and presentations relate
`
`to stents or stent applications:
`
`•
`
`T. Ischinger and R. Solar, “Optimal Stent Expansion by Predilatation
`with a New Focused Force Balloon Device”, CARDIOVASCULAR
`RADIATION MEDICINE, 4 (Abst.), 2003.
`
`- 3 -
`
`
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`T. Ischinger, R. Solar and E. Hitzke, “Improved Outcome with Novel
`Device for Low-Pressure PTCA in De Novo and In-Stent Lesions”,
`CARDIOVASCULAR RADIATION MEDICINE, 4 (1):2-7, 2003.
`
`T. Ischinger, R. Solar and E. Hitzke, “The FX miniRAIL — Long-
`Term Reduction in Target Lesion Revascularization of De Novo and
`In-Stent Lesions”, in FRONTIERS IN CARDIOLOGY, 5TH
`INTERNATIONAL CONGRESS ON CORONARY ARTERY
`DISEASE, FLORENCE, ITALY, OCT., 2003.
`
`R. Solar, “sidekick: A New Concept & Device for Bifurcation
`Stenting”, 6TH INTERNATIONAL MEETING ON
`INTERVENTIONAL CARDIOLOGY, TEL AVIV, ISRAEL, DEC.,
`2004.
`
`R. Solar, “The Y Med sideKicK™ Stent Delivery System for the
`Treatment of Coronary Bifurcation and Ostial Lesions”,
`CARDIOVASCULAR REVASCULARIZATION THERAPIES
`2007, Washington, DC, March, 2007.
`
`R. Solar, “Sidekick Stent System for the Treatment of Coronary
`Bifurcation and Ostial Lesions,” MEETING OF THE EUROPEAN
`BIFURCATION CLUB, Valencia, Spain, Sept., 2007.
`
`R. Solar, “The Y-Med SideKicK Stent,” CARDIOVASCULAR
`REVASCULARIZATION THERAPIES 2008, Washington, DC,
`March, 2008.
`
`R. Solar, “Targeted Drug Delivery: Beyond Stents and Balloons,”3rd
`NCVH Latin America, Cartegena, Colombia, March 2014.
`
`I was a co-founder of five successful medical device companies, namely (1)
`
`Versaflex Delivery Systems, Inc., (2) ThermopeutiX, Inc., (3) Y Med, Inc., (4)
`
`MEDgination, Inc., and (5) Occam International, BV.
`
`7.
`
`In 1989, I was recognized by President George Bush as one of the Ten
`
`Outstanding Young Americans (TOYA), and Junior Chamber International
`
`- 4 -
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`
`
`selected me as one of the Ten Outstanding Young People of the World for my
`
`contributions in medical innovation.
`
`8.
`
`For my time, I am being compensated at $550 per hour, my standard
`
`rate for this type of consulting activity. My compensation is in no way contingent
`
`on the result of this proceeding.
`
`9.
`
`A copy of my full curriculum vitae is attached to this Declaration as
`
`Appendix A. A list of all intellectual property cases in which I have testified as an
`
`expert, either in deposition or trial, is attached as Appendix B.
`
`II.
`
`INFORMATION REVIEWED OR CONSIDERED
`I have reviewed U.S. Patent No. 8,709,062 (the “‘062 patent”), the
`
`10.
`
`Petition in this proceeding (including the relevant materials it cites), the Board’s
`
`Institution Decision, the Patent Owner’s Preliminary Response, and the prior art
`
`references at issue (i.e., U.S. Patent Nos. 5,653,691 (Rupp) and 5,836,965
`
`(Jendersee), and 4,994,032 (Sugiyama)). I provide the following opinions
`
`regarding these materials.
`
`III. LEGAL STANDARDS
`
`11.
`
`I am not a patent attorney, and I have been instructed on certain
`
`aspects of the laws of obviousness to provide context for my opinions.
`
`12.
`
`I understand that claims 1-7, 9-15, 17-21, and 23-26 of the ‘062 patent
`
`are at issue in this Inter Partes Review proceeding. I further understand that the
`
`- 5 -
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`
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`Boards instituted one ground of challenge: obviousness of claims at issue in view
`
`of Rupp, Jendersee, Sugiyama, and the knowledge of a person of ordinary skill in
`
`the art. Institution Decision at 33-34.
`
`13.
`
`I understand that a patent is invalid under 35 U.S.C. § 103 only if “the
`
`differences between the claimed invention and the prior art are such that the
`
`claimed invention as a whole would have been obvious before the effective filing
`
`date of the claimed invention to a person having ordinary skill in the art to which
`
`the claimed invention pertains.”
`
`14.
`
`I understand that obviousness is ultimately a legal question
`
`determined by the Board, but that this legal question is premised on underlying
`
`factual issues, including:
`
`a. the scope and content of the prior art;
`
`b. the level of ordinary skill in the art;
`
`c. the differences between the claimed invention and the prior art; and
`
`d. secondary considerations of non-obviousness.
`
`15.
`
`I understand that the scope and content of the prior art must be viewed
`
`through the perspective of a person of ordinary skill in the art at the time of the
`
`invention.
`
`16.
`
`I understand that the relevant time of the obviousness inquiry in this
`
`case is August 23, 1996, the earliest filing date of the ‘062 patent.
`
`- 6 -
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`
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`17.
`
`I understand that a patent is not obvious merely by demonstrating that
`
`each of its elements was, independently, known in the prior art. I understand that it
`
`is important to identify a reason that would have prompted a person of ordinary
`
`skill in the relevant field to modify or combine the elements in the way the claimed
`
`new invention does. I understand that this rationale must be more than mere
`
`conclusory statements; instead, there must be some articulated reasoning with
`
`some rational underpinning to support the legal conclusion of obviousness. I
`
`understand that such a rationale must include a reason that would have prompted a
`
`person of ordinary skill in the relevant field to modify or combine the elements in
`
`the way the claimed new invention does. I also understand that merely asserting
`
`that prior art references are analogous art to each other is not a sufficient
`
`articulated reason with a rational underpinning to combine their respective
`
`teachings.
`
`18.
`
`I understand that the obviousness inquiry takes place at the time of the
`
`invention. Therefore, care must be used to avoid the impermissible use of
`
`hindsight in an obviousness analysis. I understand that it is improper to use the
`
`invention as a plan or template for hindsight reconstruction of bits and pieces of
`
`the prior art to form the invention.
`
`19.
`
`I understand that an invention may be found obvious if it would have
`
`been obvious to a person having ordinary skill in the art to try a course of conduct
`
`- 7 -
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`
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`constituting or resulting in the invention. When there is a design need or market
`
`pressure to solve a problem and there are a finite number of identified, predictable
`
`solutions, a person of ordinary skill has good reason to pursue the known options
`
`within his or her technical grasp. However, I understand that evidence of
`
`obviousness, especially when that evidence is proffered in support of an “obvious-
`
`to-try” theory, is insufficient unless it indicates that the possible options skilled
`
`artisans would have encountered were “finite,” small,” or “easily traversed,” and
`
`that skilled artisans would have had a reason to select the route that produced the
`
`claimed invention.
`
`20.
`
`I further understand that an invention is not obvious to try where
`
`vague prior art does not guide an inventor toward a particular solution. For
`
`example, where there are numerous possible solutions and the prior art gives no
`
`indication of which is likely to be successful, “obvious to try” does not prove
`
`obviousness. Similarly, if what was “obvious to try” was to explore a new
`
`technology or general approach that seemed to be a promising field of
`
`experimentation, but the prior art gave only general guidance as to the particular
`
`form of the claimed invention or how to achieve it, then a finding of obviousness is
`
`not warranted.
`
`21.
`
`I also understand that when the prior art “teaches away” from
`
`combining prior art references or certain known elements, discovery of a
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`- 8 -
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`
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`successful means of combining them is more likely to be non-obvious. I further
`
`understand that a reference may be said to teach away when a person of ordinary
`
`skill, upon reading the reference, would be discouraged from following the path set
`
`out in the invention, or would be led in a direction divergent from the path that was
`
`taken by the applicant. I also understand that a reference may teach away from a
`
`use when that use would render the result inoperable.
`
`22.
`
`I understand that there is no suggestion or motivation to make a
`
`modification to a prior art reference if the proposed modification would render the
`
`prior art invention unsatisfactory for its intended purpose. I also understand that an
`
`obviousness allegation cannot be supported by a combination of references that
`
`would require a substantial reconstruction and redesign of the elements shown in
`
`the primary reference as well as a change in the basic principle under which the
`
`primary reference was designed to operate.
`
`IV. THE LEVEL OF ORDINARY SKILL IN THE ART
`In Mr. Trotta’s declaration, he opines that a person of ordinary skill in
`
`23.
`
`the art at the time of the claimed invention of the ‘062 patent “would have had an
`
`undergraduate degree in mechanical or manufacturing or material science
`
`engineering, as well as at least five years of experience in the industry in designing
`
`minimally invasive catheter-based interventions.” Ex. 1003 at ¶ 80. Mr. Trotta
`
`also states that “[w]ith an undergraduate degree in a different subject matter, one of
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`- 9 -
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`ordinary skill in the art would have had five to ten years of experience in the
`
`industry in designing minimally invasive catheter-based interventions.” Id. I
`
`generally agree with these definitions and I was a person of ordinary skill in the art
`
`under this definition in August 1996.1
`
`V. The ‘062 Patent
`
`24. A stent is a tubular mesh-like implant (most commonly made of metal
`
`or alloy) that is placed in a body lumen to keep the lumen open. There are two
`
`general stent types: a self-expanding stent and a balloon expandable stent. Ex.
`
`1001 at 1:45-54. In a balloon expandable stent, the stent is mounted on the distal
`
`end of a balloon catheter, which traverses the patient’s body to the treatment site.
`
`Once reaching the treatment site, the balloon is expanded, which leads to the
`
`expansion of the stent. The balloon is then deflated to a small profile and
`
`withdrawn from the lumen, thus leaving the stent as an implant in the body lumen.
`
`25.
`
`In advancing the balloon expandable stent inside the body to the
`
`treatment site, the stent must be safely secured on the delivery balloon catheter. Id.
`
`at 2:15-18. There were two general stent securement methods. One employs
`
`“restraining means [such as a sheath] that overlay the stent.” Id. at 2:21-54. The
`
`
`1 I understand that the claimed invention in the ‘062 patent was conceived prior to
`August 23, 1996. However, for purposes of this declaration, I use August 23, 1996
`as the invention date of the ‘062 patent.
`
`- 10 -
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`
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`other involves crimping the stent (i.e., reducing the diameter of the stent) to tightly
`
`fit the stent over the balloon catheter. Id. at 2:56-59.
`
`26. The ‘062 patent relates to the latter method. Specifically, it is directed
`
`to stent securement structures for a crimped stent. However, as discussed in the
`
`Background of the Invention section of the ‘062 patent, when a stent is simply
`
`crimped on a balloon catheter, the stent still “tends to evidence a certain amount of
`
`looseness from its desired close adherence to the overall profile of the underlying
`
`catheter and balloon.” Id. at 3:5-8. In other words, “the stent tends to have a
`
`perceptible relatively slack fit in its mounted and crimped position.” Id. at 3:8-9.
`
`As a result, “[d]uring delivery, the stent can [] tend to slip and dislocate from its
`
`desired position on the catheter or even separate from the catheter, requiring
`
`further intervention by the physician.” Id. at 9-12.
`
`27. The invention of the ‘062 patent is directed to a stent securement
`
`structure (a “second member” or “proximal member”), which is an enlarged body
`
`within the balloon carried by the catheter shaft. Id. at 25:40. This structure
`
`“secure[s] the stent during tracking and delivery” and “provide[s] a good friction
`
`fit to the stent and insure good contact between the stent and underlying balloon
`
`and catheter, instead of merely crimping the stent onto the balloon and catheter and
`
`the underlying catheter and relying on the bulk of the flaccid balloon to hold the
`
`stent on.” Id. at 3:20-25.
`
`- 11 -
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`
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`28. The invention of the ‘062 patent further includes a “first member”
`
`and/or a “distal stop” that is also carried by the catheter shaft within the balloon.
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`Id. at 9:41, 25:34-36. The distal stop “provide[s] additional resistance to stent
`
`movement during delivery and to protect the leading edge of the stent during
`
`delivery.” Id. at 9:43-45.
`
`29. One of the innovative designs of the ‘062 patent is shown in Figure 3
`
`(reproduced below). Figure 3 shows a “mounting body 30,” which is an
`
`embodiment of the “second member” or “proximal member” in the claims of the
`
`‘062 patent. Id. at 9:28-34. The mounting body “provides a cushion to support
`
`and/or substrate of enlarged diameter relative to the stent to support and hold the
`
`stent [“18”] and secure it during crimping and the delivery procedure.” Id. at 9:29-
`
`32. Figure 3 also shows an embodiment of the “first member” or the “distal stop”
`
`(“36”), which is tapered at the distal portion. Id. at 9:41. As discussed above, the
`
`distal stop provides resistance to stent movement and protect stent’s leading edge
`
`during delivery. Id. at 9:43-44.
`
`
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`- 12 -
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`30. Among the claims at issue, claims 1, 13, 21, and 26 are independent
`
`claims. Claim 1, shown below, is representative of the four independent claims:
`
`1. 1. A medical device, comprising:
`an elongate shaft including a first tubular member and a
`second tubular member;
`a balloon coupled to the shaft;
`a first member coupled to the first tubular member and
`positioned within the balloon, the first member
`including a distal stop with a tapered distal portion;
`wherein the distal stop includes a proximal end face
`extending substantially perpendicular to a longitudinal
`axis of the elongate shaft;
`a second member coupled to the first tubular member and
`positioned within the balloon, the second member
`having a distal end disposed proximal of the distal
`stop; and
`a medical implant coupled to the shaft and positioned
`adjacent to the balloon.
`31. Among the dependent claims at issue, claim 7 is particularly relevant
`
`for purposes of my declaration, which reads as follows:
`
`7. The medical device of claim 1, wherein the second member is a
`support member configured to support the medical implant.
`
`
`VI. THE SCOPE AND CONTENT OF THE PRIOR ART AND THE
`DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE
`PRIOR ART
`A. Rupp
`32. Rupp, entitled “Thickened Inner Lumen For Uniform Stent Expansion
`
`And Making,” is directed to affixing a built-up layer to the outer diameter of an
`
`inner lumen of a balloon expandable stent delivery system to “cause the balloon to
`
`expand evenly and the stent to deploy uniformly.” Ex. 1023 at Abstract. The
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`- 13 -
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`
`
`specific problem addressed by Rupp is the so-called “dog boning” deformation of
`
`the balloon during the expansion process for a certain type of stent. Id. at 2:18-37.
`
`When the balloon is inflated and such stent begins to inflate, there is a tendency
`
`“towards longitudinal compression at the center of the stent.” Id. at 2:20-21. This
`
`increases the metal mass at the center of the stent and in turn increases the “radial
`
`hoop strength” at the center (which means that it takes more force to expand the
`
`center of the stent). Id. at 2:22-26. Consequently, the balloon expands first at the
`
`two ends “before expanding at the center,” thus creating a dumbbell shaped
`
`balloon (i.e., the dog boning deformation of the balloon). Id. at 2:26-28. While the
`
`dumbbell shaped the balloon is formed, the stent “slides down the expanded
`
`balloon ends toward the center of the balloon which is as yet unexpanded because
`
`of the stent’s greater radical hoop strength.” Id. at 2:29-31. “Because the stent is
`
`compressed toward the center of the balloon, complete balloon expansion may not
`
`be possible.” Id. at 2:34-36.
`
`33.
`
`In a prior art method to limit the dog boning deformation of the
`
`balloon, elastic restraining bands were employed to exert a force at the balloon’s
`
`ends for countering the balloon deformation force. Id. at 2:8-16. Adopting a
`
`different approach to address the same problem, Rupp employs a built-up layer on
`
`the catheter shaft within the balloon and in the center of the stent. An example of
`
`- 14 -
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`
`
`the built-up layers is shown as “40,” “50, and “60” in Fig. 1 of Rupp, reproduced
`
`below.
`
`The cross-sections of the built-up layers (“40,” “50, “60”) are shown in Figs.
`
`
`
`5-7 of Rupp, reproduced below.
`
`
`
`34. The built-up layer “reduces longitudinal stent slippage during stent
`
`expansion and permits uniform radial stent expansion.” Id. at 2:40-43.
`
`Specifically, the built-up layer causes the middle of the stent to be slightly
`
`expanded, thus reducing the radial hoop strength and reducing the amount of the
`
`force required to expand the middle of the stent. Id. at 7:11-14; see also id. at
`
`4:58-62 (“Since the portion of the stent 100 situated over the built up section 20 is
`
`- 15 -
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`
`
`already partially expanded, the center of the stent 100 will begin to expand to its
`
`full diameter at the same time as the balloon ends begin to expand.”); 4:62-67 (The
`
`built up layer in the central portion of the stent “improves stent expansion by
`
`reducing radial hoop strength at the center of the stent 100 and also giving this area
`
`of the stent [] a head start on expansion so as to have the effect of pre-dilating the
`
`central portion of the stent.”).
`
`35.
`
`In order to expand the middle of the stent, the built up layer “has a
`
`tapering profile at either end to direct the stent elements slightly away from the
`
`center of the stent as the stent starts to expand.” Id. at 5:7-9. In particular, “the
`
`taper would cause the zig-zag to be canted slightly toward the ends to give them
`
`that initial direction as the stent begins to expand.” Id. at 5:9-12; see also Figure 1
`
`(“40,” “50, “60”); Figures 5-7 (“40,” “50, “60”); 5:50-51 (“The built-up section 20,
`
`120, 220 proximal and distal ends taper down.”).
`
`36. The specific type of the stent prone to dog boning deformation of the
`
`balloon has a zig-zag form, “such as a sinusoidal wave,” as the helical pattern
`
`across the length of the stent. One example of such zig-zag stent is the Wiktor
`
`stent, shown in Figure 18 of Rupp (reproduced below). Id. at Fig. 18; Fig. 1
`
`(“100”). Unlike stents adopting a cylindrical form, there are less metal materials in
`
`zig-zag stents, which leads to longitudinal movement of the metal during stent
`
`expansion and presents the problem of dog done deformation of the balloon. Id. at
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`- 16 -
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`
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`4:32-35 (“Stents such as that shown in FIG. 18 having elements 315a-e can expand
`
`independently in the longitudinal direction and can present special problems not
`
`presented by stents formed of a solid cylinder.”).
`
`
`
`37. Rupp further teaches that the stent thickness is about one to 15
`
`thousandths of an inch. Id. at 3:56-57 (“The stent wire can have a diameter of
`
`about 0.001 inches to about 0.015 inches.”). The total thickness of all built-up
`
`layers can be up to 60 thousandths of an inch at its thickest point (i.e., the center).
`
`Id. at 5:46-49 (“The total increase in thickness of all the built-up layers …can
`
`range from about 0.0001 inches to about 0.060 inches at its thickest point.”). The
`
`thickness of an individual built-up layer is preferably at least two thousandths of an
`
`inch (at its thickest point) and can be up to eight thousandths of an inch (at its
`
`thickest point). Id. at 51-55 (The thickness of each individual built-up layer ranges
`
`between approximately 0.001 inches and 0.010 inches and should more preferably
`
`- 17 -
`
`
`
`should range from about 0.002 inches to about 0.008 inches in thickness, but not
`
`less than about 0.002 inches in thickness.”). The most preferable thickness of a
`
`single built-up layer is about three thousandths of an inch (at its thickest point). Id.
`
`at 5:61-62. “If a built-up layer is too thin it may puncture when crimped between
`
`the stent and marker band in addition to insufficiently building up the section to
`
`uniformly deploy the stent. If the built up section 20 becomes too thick, the distal
`
`end of the catheter will become too stiff and will fail to track properly within
`
`tortuous vessels.” Id. at 5:55-62; see also 5:41-44 (“To avoid such leaks and
`
`provide a built up section 20 of sufficient thickness to avoid the dumbbell effect,
`
`one or more free standing built-up layers can be affixed to the inner lumen tubing
`
`30, 130, 230.”). The preferable number of built-up layers is no more than three.
`
`Id. at 5:45 (“FIGS. 1-9 show 3 such built-up layers, 40, 50 and 60”); 6:14-16 (“The
`
`preferred number of built-up layers is not more than 3 because of the amount of
`
`time each layer adds to manufacturing….”).
`
`38.
`
`I understand that Mr. Trotta views the built-up layer of Rupp as the
`
`“second member” (or “proximal member”) in each claim of the ‘062 patent at
`
`issue. I also understand that Mr. Trotta does not contend that Rupp discloses the
`
`distal stop required in the claims of the ‘062 patent.
`
`1.
`
`Rupp Does Not Disclose The Requirement In Claim 7
`
`- 18 -
`
`
`
`39. As discussed above, one of the claims of the ‘062 patent at issue is
`
`claim 7, which is directed to “the second member is a support member configured
`
`to support the medical implant.” Mr. Trotta opines that the built-up layer in Rupp
`
`is a support member configured to support the stent, thus meeting the requirement
`
`of claim 7. Ex. 1003 at 134 [claim chart]. I disagree.
`
`40. Mr. Trotta states that “Rupp’s built up section 20 is a support member
`
`designed to support the stent” and cites passages of Rupp at “4:62-5:12, 5:38-45,
`
`6:1-3.” Id. These passages of Rupp are shown below:
`
`
`
`
`
`…
`
`- 19 -
`
`
`
`…
`
`
`
`
`
`41. Mr. Trotta does not point to any specific disclosure in the above cited
`
`passages that supports his opinion. See Ex. 1003 at ¶¶ 142, 143. Nor does he
`
`explain how he formed his opinion based on the above passages. Id.
`
`42.
`
`In my opinion, the built-up layer of Rupp does not meet the
`
`requirement of claim 7 of the ‘062 patent. Specifically, the built-up layer in Rupp
`
`is not a support member configured to support the stent. Rather, as shown in the
`
`above passages and elsewhere in Rupp discussed above, the built-up layer helps
`
`expand the stent, to provide uniform expansion, not support the stent to secure the
`
`stent during tracking and delivery. See, e.g., Ex. 1023 at Title (“Thickened Inner
`
`Lumen For Uniform Stent Expansion…”); Abstract (The built-up layer “causes
`
`… the stent to deploy uniformly.”); 2:40-43 (The built-up layer “reduces
`
`longitudinal stent slippage during stent expansion ….”); 4:58-62 (The built-up
`
`layer allows the center of the stent to be “partially expanded.”); 4:62-67 (The
`
`- 20 -
`
`
`
`built up layer in the central portion of the stent “improves stent expansion by
`
`reducing radial hoop strength at the center of the stent [] and also giving this area
`
`of the stent [] a head start on expansion so as to have the effect of pre-dilating the
`
`central portion of the stent.”); 5:7-12 (The built up layer “has a tapering profile at
`
`either end to direct the stent elements slightly away from the center of the stent as
`
`the stent starts to expand.”); 5:9-12 (The taper of the built-up layer would cause
`
`the zig-zag to be canted slightly toward the ends to give them that initial direction
`
`as the stent begins to expand.”); 7:11-14 (The built-up layer “causes the middle
`
`of the stent []to be slightly expanded, thus reducing the radial hoop strength and
`
`reducing the amount of the force required to expand the middle of the stent [].”)
`
`(emphases added).
`
`43. Rupp’s disclosure on stent expansion is contrasted with the ‘062
`
`patent’s disclosure on stent securement. See, e.g., Ex. 1001 at Title (“Stent
`
`Delivery System Having Stent Securement Apparatus”); 3:13-25 the
`
`“securement device is secured over the inner catheter beneath the balloon to
`
`compensate for the undesired looseness or slack that due to recoil crimping and to
`
`aid in securing the stent to the balloon,” to “secure[s] the stent during tracking
`
`and delivery” and “provide[s] a good friction fit to the stent and insure good
`
`contact between the stent and underlying balloon and catheter, instead of merely
`
`- 21 -
`
`
`
`crimping the stent onto the balloon and catheter and the underlying catheter and
`
`relying on the bulk of the flaccid balloon to hold the stent on.”) (emphases added).
`
`44. Nowhere in Rupp does it indicate that the built-up layer serves the
`
`function of supporting a stent. Indeed, in paragraph 42, I quoted every instance in
`
`Rupp where the function of the built-up layer is discussed. In each instance, it
`
`relates to stent expansion, not stent support required in claim 7 of the ‘062 patent.
`
`If anything, the built-up layer in Rupp is designed to prevent tight crimping of the
`
`center of the stent, allowing it to expand first, which is the opposite of supporting a
`
`stent required in claim 7 of the ‘062 patent. See e.g., Ex. 1001 at 2:56-59 (“the
`
`stent must be smoothly and evenly crimped to closely conform to the overall
`
`profile of the catheter and unexpanded balloon”) (emphasis added).
`
`B.
`45.
`
`Jendersee
`
`Jendersee relates to an encapsulated balloon expandable stent device
`
`to provide stent security during the stent’s journey to the target site. Ex. 1016 at
`
`Abstract and 1:9-12. As discussed above and in the ‘062 patent, encapsulation is a
`
`stent securement method distinct from crimping u
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