UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`EDWARDS LIFESCIENCES CORPORATION,
`Petitioners
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`v.
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`BOSTON SCIENTIFIC SCIMED, INC.,
`Patent Owner
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`Case No. IPR2017-00444
`Patent 6,915,560
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`DECLARATION OF NEIL SHEEHAN IN SUPPORT OF PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 6,915,560
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`
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`EDWARDS LIFESCIENCES EX. 1105
`Edwards Lifesciences v. Boston Scientific Scimed
`U.S. Patent No. 6,915,560
`
`

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`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1 
`A. 
`Background and Qualifications ............................................................. 1 
`B. 
`Topics of Opinions ................................................................................ 4 
`C.  Materials Considered ............................................................................. 4 
`LEGAL STANDARDS ................................................................................... 5 
`A. 
`Claim Construction ............................................................................... 5 
`B. 
`Obviousness ........................................................................................... 6 
`III. FACTUAL BACKGROUND AND RELEVANT CONTEXT ...................... 8 
`A. 
`Stents and Stent Crimpers ..................................................................... 8 
`B. 
`The ’560 Patent ................................................................................... 10 
`C. 
`Prosecution History ............................................................................. 16 
`1. 
`October 9, 2003 Restriction ...................................................... 16 
`2. 
`October 22, 2003 Office Action and Response ........................ 16 
`3. 
`April 22, 2004 Office Action and Response ............................. 23 
`4. 
`October 19, 2004 Office Action and Response ........................ 28 
`IV. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 32 
`V.
`CLAIM CONSTRUCTION .......................................................................... 32 
`A. 
`“A stent crimper comprising” ............................................................. 33 
`B. 
`“Dies” and “blades” ............................................................................. 34 
`C. 
`“Stationary end-walls” and “stationary plates” ................................... 35 
`VI. THE PRIOR ART .......................................................................................... 36 
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`TABLE OF CONTENTS
`(cont’d)
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`Page No.
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`VII.
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`A.  Analogous Art ..................................................................................... 36 
`1. 
`Field of Endeavor ...................................................................... 36 
`2. 
`Pertinent To The Particular Problem ........................................ 40 
`Applicant’s Admitted Prior Art ........................................................... 41 
`B. 
`Yasumi ................................................................................................. 43 
`C. 
`D.  Morales ................................................................................................ 53 
`INVALIDITY ANALYSIS ........................................................................... 56 
`A.  Obviousness Of Claims 1, 2, 6, 8-10, 14, 15, 18, 23, 25,
`27, 28, 31, 33, 37 and 40 Over Yasumi In View Of The
`AAPA .................................................................................................. 56 
`1. 
`Claim 1 ...................................................................................... 56 
`2. 
`Claim 10 .................................................................................... 72 
`3. 
`Claim 18 .................................................................................... 85 
`4. 
`Claim 27 .................................................................................... 89 
`5. 
`Claim 37 .................................................................................... 93 
`6. 
`Claim 40 .................................................................................... 97 
`7. 
`Claims 2 and 28 ......................................................................... 99 
`8. 
`Claims 6 and 15 .......................................................................100 
`9. 
`Claims 8, 25 and 33 ................................................................100 
`10.  Claims 9, 14, 23 and 31 ..........................................................103 
`11.  Reason, Basis or Motivation to Combine ...............................105 
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`-ii-
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`TABLE OF CONTENTS
`(cont’d)
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`Page No.
`
`B. 
`
`Obviousness of Claims 11, 17, 19, 26, 34, 35 and 39
`Over Yasumi In View Of The AAPA And Morales .........................109 
`1. 
`Claim 39 ..................................................................................109 
`2. 
`Claims 11, 19 and 35 ..............................................................117 
`3. 
`Claims 17, 26 and 34 ..............................................................120 
`4. 
`Reason, Basis or Motivation to Combine ...............................122 
`VIII. CONCLUSION ............................................................................................123 
`
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`-iii-
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`I. INTRODUCTION
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`A. Background and Qualifications
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`1.
`
`My name is Neil Sheehan. I am currently self-employed as a
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`consulting engineer in the field of medical products. A copy of my Curriculum
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`Vitae, which includes, among other things, my academic credentials and my
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`employment history, is attached to the Petition as Exhibit 1106.
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`2.
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`My field of expertise in this matter is medical products or devices
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`(both reusable and disposable), including mechanisms, tooling, mechanical
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`assemblies and components. This Declaration is based upon my own personal
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`knowledge, skill, experience, training and education in my field of expertise, and
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`upon information I have reviewed in connection with my retention in this matter.
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`3.
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`I have worked extensively in the areas of catheters, balloons, plastic
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`and metallic materials (including nitinol), inferior vena cava filters, vascular
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`access, syringes, pumps, tubing, bonding methods and the like. Over the course of
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`my many years in the medical device industry, I have learned much about stents
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`and their typical balloon deployment systems. In fact, I have two stents in my right
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`coronary artery owing to a congenital, tortuous path configuration.
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`4.
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`I received my Bachelor of Science in Mechanical Engineering, summa
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`cum laude, from Villanova University in 1968. I was the recipient of their 1993
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`Alumni Achievement Award for my work in the medical device field. I took
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`graduate courses in the department of Engineering and Applied Physics at Harvard
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`University in 1968-1969. I also studied biology and organic chemistry at the
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`University of California at Berkeley in 1974-1975.
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`5.
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`I have over 40 years of experience in medical device design and
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`development, with roles ranging from that of an individual contributor to that of a
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`Vice President of Engineering and Manufacturing, having been directly involved in
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`the design, development and manufacture of medical devices since 1975, both as
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`an employee and as a consultant.
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`6.
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`I am a named inventor on 41 patents (39 in the medical device field)
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`covering a broad range of products.
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`7.
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`My qualifications and testimony as an expert in the field of medical
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`devices have been accepted in 26 different cases: 20 times by Courts, four times in
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`arbitration proceedings, once at the International Trade Commission and once
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`before the Board of Patent Appeals and Interferences at the United States Patent &
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`Trademark Office.
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`8.
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`I have testified as an expert witness at trial (or hearing) and in
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`deposition in several other cases within the past four years. A list of those cases is
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`attached as Exhibit A to my Curriculum Vitae, Exhibit 1106.
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`9.
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`I have been retained by Petitioner Edwards Lifesciences Corporation,
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`(“Edwards”), to assist counsel for Petitioner Edwards as a technical expert for this
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`Petition. I bill $700 per hour for my services. No part of my compensation is
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`dependent on my opinions or on the outcome of this matter. I have no financial
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`interest in any of the parties to this case.
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`10.
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`I understand that Boston Scientific Scimed, Inc. (“the Patent Owner”)
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`has alleged that Edwards has infringed Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-
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`28, 31, 33-35, 37 and 40 of U.S. Patent No. 6,915,560 (“the ’560 patent”) in co-
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`pending litigation captioned Boston Scientific Corporation and Boston Scientific
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`Scimed, Inc. v. Edwards Lifesciences Corporation, Case No. 8:16-cv-00730-CJC-
`
`GJS (C.D. Cal) (“the Litigation”).
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`11.
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`I understand that Edwards is filing a Petition for Inter Partes Review
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`of Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39 and 40 of
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`the ’560 patent. I have been asked by counsel for Petitioners to provide technical
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`expert opinions for this Petition, including an opinion concerning the invalidity of
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`Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39 and 40 of the ’560
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`patent.
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`12.
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`The individuals involved in the prosecution of the ’560 patent and the
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`inventors are referred to collectively herein as the “Applicants.”
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`13.
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`In this declaration, where I have cited a reference as prior art against
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`the ’560 patent, either the reference predates the filing date of the ’560 patent, or I
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`have been informed by counsel for Edwards that the reference is prior art to
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`the ’560 patent.
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`14.
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`Throughout this declaration, I refer to certain exhibits that are
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`attached to the Petition. For example, the ’560 patent is attached to the Petition as
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`Ex. 1101. Other exhibits are referred to herein as “Ex. __.”
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`B.
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`Topics of Opinions
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`15.
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`I offer opinions on the following general topics:
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` the subject matter described and claimed in the ’560 patent;
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` the level of ordinary skill in the art pertaining to the ’560
`patent;
`
` Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28, 31, 33-35, 37, 39
`and 40 of the ’560 patent, including the meaning of certain
`claim terms as they would have been understood by a person of
`ordinary skill in the art as of the time of the invention;
`
` the teachings of the prior art; and
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` the invalidity of Claims 1, 2, 6, 8-11, 14, 15, 17-19, 23, 25-28,
`31, 33-35, 37, 39 and 40 in view of the prior art, and the bases
`and reasons therefore.
`
`16.
`
`I also provide background information on medical products or devices.
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`C. Materials Considered
`
`17.
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`Exhibit 1107 to the Petition is a list of the documents and things I
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`have considered in forming my opinions set forth herein.
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`18.
`
`I have also relied upon my education, training, knowledge of pertinent
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`literature and experience in the field of the ’560 patent.
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`II. LEGAL STANDARDS
`
`19.
`
`I will not offer opinions of law, as I have been retained to provide
`
`opinions solely as a technical expert. Rather, I have been advised of several legal
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`principles concerning claim construction and patent invalidity, which I used in
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`arriving at my determinations.
`
`A. Claim Construction
`
`20.
`
`I am advised that in determining whether a patent claim is anticipated
`
`in view of the prior art, the Patent Office must construe the claim by giving the
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`claim its broadest reasonable interpretation consistent with the specification. The
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`terms also are given their ordinary and customary meaning, as would be
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`understood by one of ordinary skill in the art in the context of the specification.
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`For the purposes of this review, I have analyzed each claim term in accordance
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`with its plain and ordinary meaning under the required broadest reasonable
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`interpretation.
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`21.
`
`I am also advised that the preamble to a claim may limit the claim
`
`scope when the preamble recites additional structure that is underscored as
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`important by the specification, or when the preamble provides antecedent basis for
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`a claim limitation. It is my understanding that a preamble does not limit the claim
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`scope if the body of the claim describes a structurally complete invention, and the
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`preamble merely gives a name to the invention, extols its features or benefits or
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`describes a use for the invention.
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`B. Obviousness
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`22.
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`I am advised that a claim is invalid, and therefore unpatentable under
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`35 U.S.C. § 103, if the claimed subject matter as a whole would have been obvious
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`to a person of ordinary skill in the art (“POSITA”) at the time of the alleged
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`invention. I also understand that an obviousness analysis takes into account the
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`scope and content of the prior art, the differences between the claimed subject
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`matter and the prior art and the level of ordinary skill in the art at the time of the
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`alleged invention.
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`23.
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`I am further advised that in determining the scope and content of the
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`prior art, a reference is considered appropriate prior art if it falls within the field of
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`the inventor’s endeavor. In addition, a reference is considered appropriate prior art
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`if it is reasonably pertinent to the particular problem with which the inventor was
`
`involved. A reference is reasonably pertinent if it logically would have
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`commended itself to an inventor’s attention in considering his or her problem. If a
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`reference relates to the same problem as the claimed invention, then that supports
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`the use of the reference as prior art in an obviousness analysis.
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`24.
`
`I am further advised that to assess the differences between the prior art
`
`and the claimed subject matter, the law requires the claimed invention to be
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`considered as a whole. This “as a whole” assessment requires showing that one of
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`ordinary skill in the art at the time of invention, confronted by the same problems
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`as the inventor and with no knowledge of the claimed invention, would have
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`selected the elements from the prior art and combined them in the claimed manner.
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`I understand that in considering the obviousness inquiry, it is important not to use
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`the benefit of hindsight derived from the patent itself.
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`25.
`
`I am further advised that the law recognizes several rationales for
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`combining references or modifying a reference to show obviousness of claimed
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`subject matter. Some of these rationales include: combining prior art elements
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`according to known methods to yield predictable results; simple substitution of one
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`known element for another to obtain predictable results; a predictable use of prior
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`art elements according to their established functions; applying a known technique
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`to a known device (method or product) ready for improvement to yield predictable
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`results; choosing from a finite number of identified, predictable solutions, with a
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`reasonable expectation of success; and some teaching, suggestion or motivation in
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`the prior art that would have led one of ordinary skill to modify the prior art
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`reference or to combine prior art reference teachings to arrive at the claimed
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`invention.
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`26.
`
`I am further advised that an obviousness analysis must consider
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`whether there are additional factors that would indicate that the invention was non-
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`obvious. These factors include whether there was: (i) a long-felt need in the
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`industry; (ii) any unexpected results; (iii) skepticism of the invention; (iv) teaching
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`away from the invention; (v) commercial success; (vi) praise by others for the
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`invention; and (vii) copying by others.
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`III. FACTUAL BACKGROUND AND RELEVANT CONTEXT
`
`A.
`
`Stents and Stent Crimpers
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`27.
`
`Percutaneous Transluminal Angioplasty is a medical procedure for
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`opening a constriction or narrowing of a blood vessel, such as an artery, which has
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`been constricted by the build-up of plaque.
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`28.
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`Typically, an empty collapsed balloon mounted on the distal end of a
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`balloon catheter, is passed over a guidewire into the narrowed vessel. Once the
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`balloon is properly positioned, the balloon is inflated to the desired size to
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`compress the plaque against the vessel wall and force expansion of the narrowed
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`portion within the vessel, thereby opening the blood vessel for improved flow. The
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`balloon is then deflated and withdrawn.
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`29.
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`In order to maintain the vessel in the opened state, and/or strengthen
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`the area undergoing treatment, an intravascular prosthesis, such as a stent, may be
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`employed. A stent is a metal (usually nitinol), mesh tubular support placed inside
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`the passage to aid healing or relieve an obstruction.
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`30.
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`Typically, a radially expandable stent is positioned on the balloon at
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`the distal end of the balloon catheter, the stent being crimped to a small diameter
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`around the balloon. The balloon catheter is passed over a guidewire into the
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`narrowed vessel. Once the balloon catheter is properly positioned at the desired
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`location, the stent is implanted by expansion of the balloon. The balloon portion of
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`the catheter is then deflated and withdrawn from the vessel, leaving the implanted
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`stent as a permanent scaffold to reduce the chance of re-closure (i.e., restenosis).
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`31.
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`Because the catheter and stent travel through the patient’s vasculature,
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`such as the coronary arteries, the stent must have a small delivery diameter and
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`must be firmly attached to the catheter until the physician is ready to implant it.
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`Thus, the stent must be loaded or crimped onto the catheter so that it does not
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`interfere with delivery, and it must not come off the catheter until it is implanted.
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`32.
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`To adequately mount a stent onto the balloon catheter for delivery into
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`the patient, the stent is “crimped” or otherwise radially collapsed sufficiently to
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`attach it to the balloon. Crimping a stent to a balloon catheter was well known at
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`the time of the invention.
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`33.
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`This crimping was performed in many different ways. One method
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`was manual crimping. Another known method was to use a plier-like device to
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`pinch the stent. Still other methods used dies pressed together over the stent.
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`B.
`
`The ’560 Patent
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`34.
`
`I set forth herein a summary of the ’560 patent. I do this not from
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`today’s perspective, but rather from the perspective of what one of ordinary skill in
`
`the art would have understood in the late 1990’s.
`
`35.
`
`The expressed goal of the ’560 patent is to “produce a device capable
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`of crimping a stent uniformly while minimizing the distortion of and scoring and
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`marking of the stent due to the crimping.” Ex. 1101 at 2:27-29. Although one
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`object of the invention is to crimp a stent, the patent contemplates other uses for
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`the disclosed device, such as reducing in size other tubular medical devices or as a
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`variable size balloon mold.
`
` “The present invention is directed, in one embodiment, to an
`apparatus for reducing a medical device in size. Desirably, the
`medical device is a stent, a stent-graft, a graft or a vena cava filter,
`whether self-expandable, balloon expandable or otherwise expandable,
`although the inventive apparatus may also be employed with any other
`suitable, generally tubular medical device which must be reduced in
`size.” Ex. 1101 at 2:48-55.
`
` “Desirably, the medical device is a stent…, although the inventive
`apparatus may also be employed with any other suitable, generally
`tubular medical device which must be reduced in size.” Ex. 1101 at
`2:50-55.
`
` “The inventive apparatus finds particular utility in crimping a medical
`device such as those mentioned above to a catheter or to a balloon
`disposed about a catheter. [¶] The inventive apparatus also finds
`utility in reducing the diameter of a medical device such as those
`mentioned above prior to crimping.” Ex. 1101 at 3:16-22.
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`-10-
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` “The inventive apparatus may also be used as a variable size balloon
`mold.” Ex. 1101 at 3:36-37.
`
` “The inventive apparatus may also be incorporated into a blow
`molding tool to provide a variable size balloon mold . . . .” Ex. 1101
`at 8:65-66.
`
`36.
`
`The specification describes the invention as an apparatus with “at least
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`three coupled movable blades disposed about a reference circle to form an aperture
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`whose size may be varied. . . . Each blade includes a single radial point on the
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`surface of the blade which a) lies on the circumference of the reference circle prior
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`to movement of the blade, and b) may be moved only along a radius of the
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`reference circle on movement of the blade.” Ex. 1101 at 2:56-65. The
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`specification also discloses “an actuation device which is capable of moving the
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`blade to alter the size of the aperture.” Id. at 2:59-60.
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`37.
`
`Figures 2a and 2b show one preferred embodiment of the blade
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`configuration comprising eight coupled blades, depicted before and after reducing
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`a stent in size. Ex. 1101 at 3:60-63.
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`-11-
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`Polygonal
`Aperture 118
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`
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`Ex. 1101, Figs. 2a, 2b (color and annotations added).
`
`38.
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`Each blade has a beveled end 108 so as to mesh against an adjacent
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`blade, and the blades cumulatively define a polygonal aperture. Ex. 1101 at 4:59-
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`62. Element 122 identifies the single radial point (located at the tip of the blade on
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`the beveled end) that lies on the radial line 126 of the reference circle 114. Id. at
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`4:66-67. Element 122 moves along the radial line 126 when moving outward to
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`increase the size of the aperture and when moving inward to reduce the size of the
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`aperture. Id. at 4:66-5:4.
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`39.
`
`Figure 4A is a partial front view of a disclosed embodiment and
`
`Figure 4c is a partial side view.
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`-12-
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`Radial Slot 146
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`Actuation Plate 142
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`Connecting Link 130
`
`Linear Slide 154
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`Non-rotating Plate 156
`
`Cam Follower Bearing 150
`
`Blade 106
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`
`
`Non-rotating Plate 156
`
`Linear Slide 154
`
`Actuation Plate 142
`
`Cam Follower Bearing 150
`
`Slot 146
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`Connecting Link 130
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`Blade 106
`
`Ex. 1101, Figs. 4A, 4c (annotations and color added).
`
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`-13-
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`40.
`
`In the depicted embodiment each blade 106 (green) has a connecting
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`link 130 (red) that extends from the end 110 of the blade. Ex. 1101 at 5:6-7. The
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`connecting link 130 (red) ends in mounting means 134 that both attaches to a linear
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`bearing block 212 on one side and interfaces with an actuation device, shown
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`generally at 138, on the other. Id. at 5:7-10. The actuation device 138 has an
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`actuation plate 142 (purple) that rotates to simultaneously move the blades to alter
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`the size of the aperture 118. See id. at 5:11-14, 46-62.
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`41.
`
`Figure 5a is a partial front view of an alternative disclosed
`
`embodiment and Figure 8a is a partial side view:
`
`Actuation Plate 142
`
`Cam Slot 146
`
`Linear Slide 154
`
`Cam Follower Bearing 150
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`Connecting Link 130
`
`Blade 106
`
`Ex. 1101, Fig. 5a (annotations and color added).
`
`Non-rotating Plate 156
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`
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`-14-
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`Actuation Plate 142
`Non-rotating Plate 156
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`
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`Cam Follower Bearing 150
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`Linear Slide 154
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`Connecting Link 130
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`Blade 106
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`
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`Ex. 1101, Fig. 8a (annotations and color added).
`
`42.
`
`The embodiment depicted in Figs. 5a (Ex. 1101 at 5:66-6:17 & 6:28-
`
`41), and 8a (id. at 7:9-21), operates in a manner similar to the embodiment
`
`described above with respect to Figures 4A and 4c. The primary difference is that
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`the blades are attached to the connecting links at an angle, and the linear slides are
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`arranged to slide along a radial line, labeled 158. Id. at 6:43-50.
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`43.
`
`I address seven independent claims and 17 dependent claims in this
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`declaration.
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`-15-
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`

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`
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`C.
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`Prosecution History
`
`44.
`
`U.S. Patent Application No. 10/444,807, which issued as the ’560
`
`patent, is part of a family of patents deriving from an application originally filed on
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`September 22, 1999. During prosecution, the Applicant elected to proceed only on
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`apparatus claims, and significantly amended the claims four times in view of
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`numerous rejections from the Examiner. Finally, on February 14, 2005, the
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`Examiner allowed the claims. The relevant amendments are discussed below.
`
`1. October 9, 2003 Restriction
`
`45.
`
`U.S. Patent Application No. 10/444,807 was filed on May 23, 2003
`
`with 26 claims. Ex. 1102 at 153-157. On October 9, 2003, the Applicant
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`responded to a restriction requirement by selecting the apparatus claims, canceling
`
`the original apparatus claims and submitting 35 new apparatus claims. Id. at 92-98.
`
`2. October 22, 2003 Office Action and Response
`
`46.
`
`On October 22, 2003, the Patent Examiner rejected all the claims in a
`
`non-final office action. Ex. 1102 at 69-80. The Examiner rejected independent
`
`Claims 27, 36, 44 and 52 as anticipated by or obvious over U.S. Patent No.
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`5,261,263 (“Whitesell”). See id. at 72-74. The Examiner found that Whitesell
`
`teaches a crimper comprising a plurality of movable dies 18 arranged to form an
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`iris, the dies disposed about an aperture 30 and a rotatable actuation device 26
`
`coupled to the blades, rotation of the actuation device causing the dies to move
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`inward and reduce the size of the aperture or outward to increase the size of the
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`aperture. Id. at 72-73.
`
`Movable Wedge-
`Shaped Dies 18
`
`Rotatable Actuation Device 26
`
`Movable Wedge-Shaped Dies 18
`
`Rotatable Actuation Device 26
`
`
`
`Ex. 1102 at 84 (including Whitesell Figs. 1 and 2 with Examiner’s handwritten
`
`notes (colors and annotations added)).
`
`-17-
`
`

`
`
`
`47.
`
`Whitesell describes radial pliers or a wrench for gripping cylindrical
`
`workpieces. Ex. 1115 at 1:28-42, 3:40-41. The Examiner in particular noted:
`
`[T]he crimper of Whitesell is considered a stent crimper
`because a recitation of the intended use of the claimed invention
`must result in a structural difference between the claimed
`invention and the prior art in order to patentably distinguish the
`claimed invention from the prior art. If the prior art structure is
`capable of performing the intended use, then it meets the
`claim. . . . Clearly, the crimper of Whitesell is capable of
`performing crimping of a stent.
`
`Ex. 1102 at 72.
`
`48.
`
`The Examiner also rejected independent Claims 27, 36, 44 and 52 as
`
`obvious over the AAPA in view of Whitesell. Ex. 1102 at 74-76. The Examiner
`
`found that the AAPA teaches a stent crimper comprising a plurality of movable
`
`dies 24 arranged to form an iris, the dies disposed about an aperture 26 and a
`
`rotatable actuation device 28. Id. at 74-75.
`
`-18-
`
`

`
`
`
`Rotatable Actuation Device 28
`
`Crimping Blades
`
`
`
`Ex. 1101, Fig. 1 (annotations and color added).
`
`49.
`
`The Examiner found that the AAPA does not teach “each of the dies
`
`having a longitudinal axis which is tangent to the aperture,” but Whitesell teaches
`
`that element. Ex. 1102 at 74. The Examiner explained that it would have been
`
`obvious to a POSITA
`
`to have provided the invention of [the AAPA] with dies having
`a longitudinal axis which is tangent to the aperture, in light of
`the teachings of Whitesell, in order to provide a symmetric
`crimping deformation. It is noted that Whitesell recognizes the
`benefits of using radial applying crimping forces over linearly
`applied forces like the one taught by [AAPA].
`
`Ex. 1102 at 74-75.
`
`-19-
`
`

`
`
`
`50.
`
`In response, on January 22, 2004, the Applicant amended independent
`
`Claims 27, 36, 44 and 52 to include a limitation resulting in dies with straight or
`
`flat sides facing a substantially polygonal aperture when moved to open or close
`
`the aperture (the “straight-sided die/polygonal aperture limitation”). Ex. 1102 at
`
`57-60. Specifically, the Applicant added new limitations as shown below:
`
`
`
`
`
`
`
`-20-
`
`

`
`
`
`
`
`Ex. 1102 at 57-59.
`
`51.
`
`The Applicant argued that Whitesell does not teach the added
`
`limitations of Claim 27 because, as depicted below in Whitesell Figure 4, no angle
`
`is formed between the stent contacting surfaces of the dies in Whitesell in the
`
`closed configuration. Ex. 1102 at 63. Similarly, the Applicant argued that
`
`Whitesell does not teach straight or flat sides that face the center of the aperture in
`
`the closed position, as required by amended Claims 36 and 44, or a substantially
`
`regular polygonal shape in the closed position, as required by amended Claim 52.
`
`Id. at 63-64.
`
`-21-
`
`

`
`
`
`
`
`Ex. 1115, Fig. 4.
`
`52.
`
`The Applicant argued that the AAPA did not disclose a plurality of
`
`dies arranged to form an iris, noting that:
`
`[A]n iris defining an aperture with a substantially regular
`polygonal shape acts about an opening or aperture such that the
`opening or aperture maintains a similar geometric shape while
`minimizing or maximizing the size of the aperture. . . . the
`AAPA manipulates the stent to be crimped by having elongate
`portions poke radially inward and press portions of the stent in
`order to minimize the size of the stent. The aperture is not
`being minimized; elongate members are merely being
`introduced into the aperture to crimp the stent.
`
`Ex. 1102 at 65. The Applicant also argued that the AAPA did not disclose the
`
`additional limitations added by amendment to Claims 27, 36, 44 and 52. Id. at 65-
`
`66.
`
`53.
`
`The Applicant also added new independent claims, including Claim
`
`63, as shown below:
`
`-22-
`
`

`
`
`
`
`
`Ex. 1102 at 60-61.
`
`3.
`
`April 22, 2004 Office Action and Response
`
`54.
`
`On April 22, 2004, the Examiner rejected Claims 27, 36, 52 and 63 in
`
`a final office action. Ex. 1102 at 42-52.
`
`55.
`
`The Examiner rejected Claims 27 and 63 as anticipated by U.S. Patent
`
`No. 3,695,087 (“Tuberman”). Ex. 1102 at 45. Tuberman describes an apparatus
`
`for forming cylindrical points on metal tubes. Ex. 1104 at Abstract. The Examiner
`
`found that Tuberman teaches a plurality of movable dies arranged to form an iris,
`
`the iris defining an aperture of a substantially regular polygonal shape, the dies
`
`disposed about the aperture, each of the dies have a contacting surface 27, each die
`
`arranged such that the contacting surface extends along a line that intersects the
`
`contacting surface 27 of an adjacent die and forms an angle, the angle remaining
`
`substantially the same when the dies move to open the aperture and when the dies
`
`move to close the aperture. Ex. 1102 at 45. The Examiner also found that
`
`Tuberman teaches curved dies as recited in Claim 63. Id. (citing Tuberman Fig.
`
`24)
`
`-23-
`
`

`
`
`
`Die Blocks 71-74
`
`
`
`Ex. 1116, Figs. 21-26 (color and annotation added).
`
`56.
`
`The Examiner rejected Claims 27, 36 and 52, as anticipated by U.S.
`
`Patent No. 6,176,116 (“Wilhelm”). Ex. 1102 at 46. Wilhelm describes a crimping
`
`tool for crimping lead end sleeves, contact sockets or plugs onto electrical
`
`conductors. Ex. 1117 at Abstract. The Examiner found that Wilhelm taught dies
`
`18 arranged to form an iris 32 with angles that remain substantially the same when
`
`the dies move to open or close. Ex. 1102 at 46. The Examiner also found that
`
`Wilhelm teaches a rotatable actuation device 17 coupled to the dies 18 and wedge-
`
`shaped dies. Id.
`
`-24-
`
`

`
`
`
`Rotatable Actuation Device 16
`
`Movable Dies 18
`
`
`
`Ex. 1117, Fig. 1 (color and annotation added).
`
`57.
`
`The Examiner considered Tuberman and Wilhelm stent crimpers
`
`because both are capable of crimping a stent. Ex. 1102 at 45-46.
`
`58.
`
`The Applicant filed a response to the office action and an amendment
`
`on July 22, 2004. Ex. 1102 at 29-39. The Applicant deleted the straight-sided
`
`die/polygonal aperture limitation from Claim 27 and added new limitations to
`
`independent Claims 27, 36, 44, 52 and 63 directed to dies disposed “between
`
`stationary end-walls substantially centered about the longitudinal axis,” (the
`
`“stationary end-walls limitation”). Ex. 1102 at 29-33. Specifically, the Applicant
`
`made the amendments shown below:
`
`-25-
`
`

`
`
`
`Claim 27. (Currently Amended)
`
`A stent crimper comprising:
`
`a plurality ofmovable dies arranged to form anMs the iris
`
`defining an aperture of a substantially regular polygonal shape, the dies disposed about an the
`
`aperture and between sggigngy end-walls which are disposed am the longitudinal axis, the
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