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 IPR2017-00444
`Patent 6,915,560 B2
`_______________
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and STACY B.
`MARGOLIES, 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
`
`Page 1 of 107
`
`Edwards Lifesciences v. Boston Scientific
`U.S. Patent No. 6,915,560
`IPR2017-00444 EX. 2016
`
`

`

`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................................. 10
`V. STATE OF THE ART BEFORE SEPTEMBER 22, 1999............................. 10
`VI. The ‘560 Patent........................................................................................... 13
`A.
`The ‘560 Patent ....................................................................................... 13
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART AND THE
`DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE PRIOR
`ART ................................................................................................................... 18
`A. Yasumi .................................................................................................... 18
`1.
`Yasumi Does Not Disclose “A Stent Crimper,” “A Stent”, “A Medical
`Balloon,” “A Catheter,” Or Related Requirements........................................ 23
`2.
`Yasumi Does Not Disclose Limitations Relating To Dies Operatively
`Engaged With An End-Wall.......................................................................... 24
`3.
`Yasumi Does Not Disclose Limitations Relating To Inward Or Outward
`Movement Of The Dies................................................................................. 29
`B. Morales.................................................................................................... 31
`VIII. ONE OF ORDINARY SKILL IN THE ART WOULD NOT HAVE
`CONSIDERED THE FIGURE 8 EMBODIMENT A STENT CRIMPER OR
`MODIFY IT TO CRIMP A STENT EITHER ALONE OR IN COMBINATION
`WITH MORALES............................................................................................... 33
`1.
`ONE OF ORDINARY SKILL IN THE ART WOULD NOT HAVE
`CONSIDERED THE FIGURE 8 EMBODIMENT A STENT CRIMPER OR
`CAPABLE OF CRIMPING A STENT ......................................................... 33
`2.
`ONE OF ORDINARY SKILL IN THE ART WOULD NOT HAVE
`MODIFIED THE FIGURE 8 EMBODIMENT TO CRIMP A STENT
`EITHER ALONE OR IN COMBINATION WITH MORALES................... 38
`IX. SECONARY CONSIDERATIONS OF NON-OBVIOUSNESS ................ 40
`
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`I.
`
`I, Ronald J. Solar, state and declare as follows:
`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.”
`I first began working in the balloon catheter field in 1980 when the
`3.
`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
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`including balloon catheters and stents. In particular, my expertise includes stent
`crimping, which is the subject matter of this proceeding.
`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”
`
`(cid:120)
`
`(cid:120)
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`(cid:120)
`
`(cid:120)
`
`(cid:120)
`
`(cid:120)
`
`(cid:120)
`
`U.S. Patent No. 5,549,635 filed in 1994 and entitled “Non-
`Deformable Self-Expanding Parallel Flow Endovascular Stent and
`Deployment Apparatus Therefore”
`U.S. Patent No. 5,669,880 filed in 1993 and entitled “Stent Delivery
`System”
`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”
`(cid:120)
`Specifically, two of the U.S. Patents I hold relate to methods and apparatuses for
`crimping a stent, which will be discussed in more detail below.
`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.
`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.
`
`(cid:120)
`
`(cid:120)
`
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`(cid:120)
`
`(cid:120)
`
`(cid:120)
`
`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
`selected me as one of the Ten Outstanding Young People of the World for my
`contributions in medical innovation.
`
`(cid:120)
`
`(cid:120)
`
`(cid:120)
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`For my time, I am being compensated at $550 per hour, my standard
`8.
`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
`10.
`I have reviewed U.S. Patent No. 6,915,560 (the “‘560 patent”), the
`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. 4,454,657 (Yasumi) and 5,893,852
`(Morales). I have also reviewed samples, documents, discovery responses, and
`deposition transcripts produced in the district court litigation. 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 claim construction and obviousness to provide context for
`my opinions.
`12.
`I understand that claims 1-2, 6, 8-11, 14-15, 17-19, 23, 25-28, 31, 33-
`35, 37, and 39-40 of the ‘560 patent are at issue in this Inter Partes Review
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`proceeding. I further understand that the Boards instituted two grounds of
`challenges: (1) obviousness of claims 1-2, 6, 8-11, 14-15, 17-19, 23, 25-28, 31, 33-
`35, 37, and 39-40 in view of the Figure 8 embodiment of Yasumi alone and (2)
`obviousness of claims 11, 17, 19, 26, 34, 35, and 39 in view of the Figure 8
`embodiment of Yasumi and Morales. Institution Decision at 25.
`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.
`I note that I did not see any discussion in Mr. Sheehan’s declaration of secondary
`considerations of non-obviousness.
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`I understand that the scope and content of the prior art must be viewed
`15.
`through the perspective of a person of ordinary skill in the art at the time of the
`invention.
`I understand that the relevant time of the obviousness inquiry in this
`16.
`case is September 22, 1999.
`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.
`I understand that the obviousness inquiry takes place at the time of the
`18.
`invention. Therefore, care must be used to avoid the impermissible use of
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`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
`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
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`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. With regard to objective evidence of non-obviousness, I understand
`that such evidence can include secondary considerations, such as:
`(cid:120) Commercial Success: I understand that evidence of commercial
`success can be considered as an indication of non-obviousness where
`there is a nexus, or legally and factually sufficient connection,
`between the claimed invention and the commercial success. I
`understand that this means the success must be shown to have in some
`way been due to the nature of the claimed invention, but the invention
`need not be the sole basis of the commercial success.
`(cid:120) Long-felt Need: I understand that evidence that a claimed invention
`solved longstanding problems or fulfilled a long-felt need in an
`industry can be considered as an indication of non-obviousness.
`(cid:120) Prior Failure: I understand that evidence that others have tried and
`failed to solve the problem or provide the need resolved by the
`claimed invention is an indication of non-obviousness.
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`IV. THE LEVEL OF ORDINARY SKILL IN THE ART
`22.
`In Mr. Sheehan’s declaration, he opines that a person of ordinary skill
`in the art at the time of the claimed invention of the ‘560 patent “would have had at
`least a Bachelor of Science degree in mechanical engineering, industrial design,
`biomedical engineering or equivalent work experience, as well as five to ten years
`of experience in the design or development of medical device.” Ex. 1105 at ¶ 66.
`I generally agree with this definition and I was a person of ordinary skill in the art
`under this definition in September 22, 1999.1
`V.
`STATE OF THE ART BEFORE SEPTEMBER 22, 1999
`23. 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.
`1101 at 1:32-35. 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.
`
`1 I understand that the claimed invention in the ‘560 patent was conceived prior to
`September 22, 1999. However, for purposes of this declaration, I use September
`22, 1999 as the invention date of the ‘560 patent.
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`The first successful human procedure using a balloon expandable
`24.
`stent was conducted in the late 1980s. Ex. 2023 at 1-16. During the next decade,
`balloon expandable stents gained increasing acceptance. By late 1990s, balloon
`expandable stents became the dominant coronary stent products as opposed to self-
`expanding stents.
`25.
`Patent Owner (including its predecessor, Scimed Life Systems, Inc.)
`has sold numerous balloon expandable stents (including drug-eluting stents) since
`the 1990s, such as NIR, Express, Taxus, Liberte, Promus, and Synergy products.
`Ex. 2024 at 46-49.
`26.
`Prior to introducing a balloon expandable stent into a patient’s body, it
`needs to be tightly fitted on the balloon catheter such that it will not fall off the
`balloon catheter during its journey to the treatment site. To do so, the stent’s
`diameter is reduced such that it is securely mounted onto the balloon catheter, a
`process known as stent crimping.
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`The ‘560 patent relates to a device that uniformly crimps a stent onto
`27.
`a balloon catheter. As described in the ‘560 patent, prior to the invention of the
`‘560 patent, a stent had been hand-crimped by physicians, which often resulted in
`the application of “undesired uneven forces to the stent.” Ex. 1101 at 1:48-50.
`28. As a person of ordinary skill in the art at the relevant time frame, I too
`recognized the problem of uneven stent crimping and tried to find a solution to
`solve this problem. On March 13, 1997, I filed a U.S. Application Serial No.
`08/816,259, which matured into U.S. Patent Nos. 5,810,838 (the “‘838 patent”)
`and 5,971,992 (the “‘992 patent,” which is a divisional patent of the ‘838 patent).
`Exs. 2021, 2022. In the ‘838 patent, I explained that “a major drawback” in
`crimping a stent at the time was that the stent was “not uniformly compressed onto
`the balloon of the delivery catheter.” Ex. 2021 at 2:58-61. Specifically, I noted
`that:
`
`Indeed, the hand crimping of the stent or stented graft onto the balloon of the
`delivery catheter usually results in uneven crimping. Such non-uniform or
`uneven crimping of the stent or stented graft onto the balloon in turn results
`in non-uniform or uneven re-expansion of the stent or stented graft when
`radially expanded by the inflation of the balloon. If re-expanded in a
`nonuniform manner, the stent or stented graft, though being in contact with
`the luminal surface of a particular anatomical passageway, will not
`necessarily exert even pressure thereagainst, which is undesirable due to the
`increased risk of the stent or stented graft dislodging from its operative
`position within the treatment site. Additionally, such non-uniform crimping
`may cause problems during the advancement of the delivery catheter
`through the anatomical passageway to the desired treatment site. Such
`problems include those portions of the stent or stented graft which are not
`compressed against the balloon of the delivery catheter inadvertently
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`contacting and damaging the lining of the luminal surface of the anatomical
`passageway.
`Id. at 2:61-3:13.
`29.
`In an attempt to solve the problem of uneven stent crimping, I
`developed, in the ‘838 patent, a method and apparatus for uniformly crimping a
`stent using a fluid pressure chamber.
`VI. The ‘560 Patent
`A.
`The ‘560 Patent
`30.
`The ’560 patent discloses an innovative crimper that includes both
`coupled and movable blades forming a variable-sized aperture that applies even
`forces while minimizing the distortion of the stent. Ex. 1101 at 2:26-29, 2:56-65.
`An exemplary crimper design is shown in Figure 4A of the ’560 patent:
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`In Figure 4A, the stent crimper comprises eight coupled blades 106
`31.
`(orange) disposed about a reference circle 114 (green) to form an aperture 118, in
`which the stent is disposed. Id. at 4:66-5:12. Each blade 106 includes a radial
`point 122 (yellow), which lies on a radial line 126 (blue) of the reference circle
`114. Each blade 106 may only move in a direction parallel to the radial line 126.
`Id.; see also id. at 3:7-15.
`32.
`In use, as an actuation plate 142 is rotated in a clockwise direction, the
`clockwise motion of the actuation plate is translated into linear motion of each
`linear slide 154 and blade 106 via bearing 150. Id. at 5:46-62. Each blade 106
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`moves outward in a direction parallel to the radial line 126, resulting in the opening
`of aperture 118. Conversely, as the actuation plate 142 is rotated in a counter-
`clockwise direction, each blade 106 moves inward in a direction parallel to the
`radial line 126, resulting in the closing of aperture 118. Id.
`33. Among the challenged claims, claims 1, 10, 18, 27, 37, 39, and 40 are
`independent claims as shown below with the particularly relevant claim language
`highlighted in bold:
`1. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris having a longitudinal
`axis, the iris defining an aperture, the dies disposed about the aperture
`and between stationary end-walls which are disposed about the
`longitudinal axis, at least one of the stationary end-walls operatively
`engaged to the dies at distinct connection locations such that the
`number of distinct connection locations and the number of dies are
`the same;
`each die having a first straight side and a second straight side, the first
`straight side and the second straight side conver[g]ing to form a tip;
`wherein a portion of the first straight side of each die faces the aperture,
`each first straight side parallel to the second side of an adjacent die.
`10. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris, the dies disposed about
`an aperture, the aperture having a longitudinal axis and a substantially
`regular polygonal shape, each of the dies having an inward facing straight
`side which faces the longitudinal axis of the aperture, both when the dies
`move to maximize the aperture and when the dies move to minimize the
`aperture, the dies between two stationary end-walls disposed about the
`longitudinal axis, the longitudinal axis passing through a point
`substantially centered on the end-walls,
`a rotatable actuation device coupled to the dies, rotation of the actuation
`device causing the inward facing straight sides of the dies to move
`inward and reduce the size of the aperture or outward so as to increase
`the size of the aperture.
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`18. A stent crimper comprising:
`eight or more movable dies arranged to form an iris, the iris defining an
`aperture of a substantially regular polygonal shape, the aperture having a
`longitudinal axis, each die having an inward facing flat portion which
`faces the longitudinal axis of the aperture both when the dies move to
`maximize the aperture and when the dies move to minimize the aperture,
`the dies between stationary end walls and operatively engaged to at
`least one of the stationary end-walls, the stationary end-walls disposed
`about the longitudinal axis,
`the iris comprising at least eight of the inward facing flat portions, the
`aperture being reducible in size by moving the inward facing flat
`portions toward the longitudinal axis of the aperture,
`a rotatable actuation device coupled to the dies, rotation of the actuation
`device causing the inward facing straight sides of the dies to move
`inward and reduce the size of the aperture or outward so as to increase
`the size of the aperture.
`27. A stent crimper comprising:
`an aperture with a plurality of movable blades disposed thereabout, the
`aperture having a longitudinal axis and being substantially polygonal, the
`blades between stationary end-walls substantially centered about the
`longitudinal axis, the blades coupled to one another so as to be
`movable inward or outward simultaneously, movement of the blades
`outward increasing the size of the aperture, movement of the blades
`inward decreasing the size of the aperture, the aperture remaining
`substantially regular polygonal when it is sized to receive a stent therein
`and when the blades minimize the aperture.
`37. A stent crimper comprising:
`a plurality of overlapping movable dies arranged to form an iris, the dies
`disposed about an aperture, the aperture having a longitudinal axis, the
`dies between stationary end-walls disposed about the longitudinal axis,
`the dies operatively engaged to at least one of the stationary end-
`walls;
`each die having a first straight side and a second straight side, the first
`straight side and the second straight side converging to form a tip;
`wherein a portion of the first straight side of each die faces the aperture,
`each first straight side parallel to the second side of an adjacent die.
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`39. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris disposed about an
`aperture, the aperture having a center and a first opening and a second
`opening, the dies constructed and arranged to have a length exceeding
`the length of a stent with a longitudinal axis passing through both the
`first opening and the second opening, each die in communication with an
`actuation device, the actuation device constructed and arranged such that
`rotational motion of the actuation device opens or closes the aperture;
`each die having a first straight side and a second straight side, the first
`straight side and the second straight side converging to form a tip;
`wherein a portion of the first straight side of each die faces the aperture,
`each first straight side parallel to the second side of an adjacent die.
`40. A stent crimper comprising:
`a plurality of movable dies arranged to form an iris disposed about an
`aperture, the aperture having a longitudinal axis, the plurality of movable
`dies between stationary plates disposed about the longitudinal axis, each
`die in communication with an actuation device, the actuation device
`constructed and arranged such that rotational motion of the actuation
`device opens or closes the aperture, the dies operatively engaged to at
`least one of the stationary plates;
`each die having a first straight side and a second straight side, the first
`straight side and the second straight side conver[g]ing to form a tip;
`wherein a portion of the first straight side of each die faces the aperture,
`each first straight side parallel to the second side of an adjacent die.
`34. Among the challenged claims, dependent claims 2, 11, 17, 19, 25-26,
`28, and 33-35 are particularly relevant for purposes of my declaration. These
`claims read as follows with the claim language of interest highlighted in bold:
`2. The stent crimper of claim 1 having a rotatable actuation device
`coupled to the dies, rotation of the actuation device causing the dies to
`move inward and reduce the size of the aperture or outward so as to
`increase the size of the aperture.
`11. The stent crimper of claim 10 wherein a stent is disposed about a
`medical balloon, the medical balloon disposed about a catheter.
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`17. The stent crimper of claim 10 wherein an entire stent is disposed in
`the aperture.
`19. The stent crimper of claim 18 wherein a stent is disposed about a
`medical balloon, the medical balloon disposed about a catheter.
`25. The stent crimper of claim 18 wherein the dies are moved
`cooperatively inward during the moving step.
`26. The stent crimper of claim 18 wherein an entire stout [sic: stent] is
`disposed in the aperture.
`28. The stent crimper of claim 27 further comprising a rotatable actuation
`device coupled to the blades, rotation of the actuation device causing the
`blades to move inward or outward.
`33. The stent crimper of claim 28 wherein the dies are moved
`cooperatively inward during the moving step.
`34. The stent crimper of claim 28 wherein an entire stent is disposed in
`the aperture.
`35. The stent crimper of claim 27 wherein a stent is disposed about a
`medical balloon, the medical balloon disposed about a catheter.
`VII. THE SCOPE AND CONTENT OF THE PRIOR ART AND THE
`DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE
`PRIOR ART
`A.
`Yasumi
`35. Yasumi was filed in 1980 and issued in 1984. It is directed to an
`aperture setting device that could be used with a drawing die, a chuck, a press tool
`(or the like) to change the polygonal size of an electric wire or the like. Ex. 1103
`at Title (“Aperture Setting Device”); Abstract; 1:8-44. Yasumi is assigned to an
`aviation electronics company. Id. at Assignee (“Japan Aviation Electronics
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`Industry Limited”). In the aviation electronics industry, a guide device was used
`for “guiding an electric wire or the like to a predetermined position.” Id. at 1:14-
`31. There was a need to change the size of a polygonal configuration of an electric
`wire. Id.
`36. Yasumi discloses an aperture setting device with multiple movable
`pieces each of which has a triangular shape. These triangular movable pieces are
`arranged in such a way to form a polygonal aperture. Id. at 1:46-60. All claims of
`Yasumi are directed to a “center aligning device” comprising the disclosed
`aperture. Id. at 11:35-12:50.
`37.
`I understand that in the Institution Decision, the Board limited the
`embodiment of Yasumi that Petitioner could rely on to Figure 8 (and Figures 3 and
`10 “as they relate to Figure 8”). Institution Decision at 11. Figure 8 is reproduced
`below. It is “an embodiment of aperture setting device of the present invention as
`used in a manual forming and pressing tool.” Ex. 1103 at 7:33-35.
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`38. While Yasumi provides an exploded view of the components of the
`Figure 8 embodiment (as shown above) and describes in some respects how
`components are assembled at column 7, line 39 to column 9, line 34, the
`disclosures lack sufficient detail or clarity to indicate how the Figure 8
`embodiment could actually operate to achieve its intended purpose. The principle
`of aperture opening and closing in Figure 8 appears to be first discussed with
`respect to Figures 3 and 10 at column 5, line 39 to column 7, line 14 of Yasumi.
`Specifically, the moveable pieces (12-19 in Fig. 3) are mounted on a frame (20 in
`Fig. 3), which is in turn mounted on a guide base (21 in Fig. 3). Id. at 5:58-6:8.
`The drive pins (22-1 to 22-8 in Fig. 3) are planted on the guide base 21. Id.
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`For the aperture to close, Yasumi states that:
`39.
`Turning the guide base 21 about the axis 0 clockwise in FIG. 3 relative to
`the frame 20, the drive pins 22-1 to 22-8 move on the same circle about the
`axis 0 relative to the frame 20. The drive pins 22-1 to 22-8 drive the
`movable pieces 12 to 19 through the elongated holes 23-1 to 23-8,
`respectively, by which the movable pieces are moved along their bases to
`approach the axis 0.
`Id. at 6:1-8.
`40. Under this mechanism, it would seem that rotating the movable
`handle (37 in Fig. 8) (bringing the movable handle towards the fixed handle (26 in
`Figure 8) would turn the frame relative to the fixed drive pins. However, Yasumi
`describes that “the setting piece (32 in Fig. 8) also turns,” but there is no
`description of the setting piece engaged to the moveable handle to effect such
`turning. Id. 8:46-47 (emphasis added). Further, Yasumi teaches that the setting
`piece butts against the fixed handle when the set angle is reached, thus limiting
`further rotational movement of the setting piece and fixing the pins. Id. at 8:45-50.
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`And then Yasumi teaches that th