UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC.,
`Petitioner,
`
`v.
`
`TMT SYSTEMS, INC.,
`Patent Owner.
`
`IPR Trial No. IPR2021-01533
`U.S. Patent No. 7,101,393
`
`DECLARATION OF DR. ELLIOT L. CHAIKOF, M.D., PH.D.
`REGARDING U.S. PATENT NO. 7,101,393 CLAIMS 1, 2, 4, 10, 11, AND 26
`
`MEDTRONIC 1103
`
`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`Table of Contents
`I. 
`INTRODUCTION ........................................................................................... 1 
`II.  QUALIFICATIONS AND EXPERIENCE ..................................................... 1 
`III.  LEGAL PRINCIPLES ..................................................................................... 6 
`
`IV.  MATERIALS CONSIDERED ...................................................................... 10 
`V. 
`LEVEL OF ORDINARY SKILL IN THE ART ........................................... 10 
`VI.  OVERVIEW OF THE STATE OF THE ART.............................................. 12 
`
`A.  Scope of Opinion ............................................................................................ 7 
`B.  Anticipation .................................................................................................... 7 
`C.  Obviousness .................................................................................................... 7 
`D.  Claim Dependency ....................................................................................... 10 
`A.  The State of the Art ...................................................................................... 12 
`1.  Historical Treatment of Aneurysms ......................................................... 12 
`2.  Alternatives to “Open Surgery” Were Pursued Since At Least
`3.  Endovascular Stent Grafts to Treat AAA Became Well-Known and
`4.  Various Designs for Stents Were Well-Known and Widely Used
`5. 
`B.  Short Summary of the Prior Art ................................................................... 33 
`A.  Description of the ’393 Patent ...................................................................... 35 
`B.  Priority Date of the ’393 Patent .................................................................... 48 
`C.  Summary of the ’393 Patent’s Prosecution History ..................................... 48 
`D.  Summary of the ’393 Patent’s Child Applications’ File Histories .............. 52 
`
`Before 2002 .............................................................................................. 23 
`It Was Well-Known that Different Materials Could be Used for
`Stents Before 2002 ................................................................................... 31 
`
`the 1970s .................................................................................................. 16 
`
`Available for Use in the 1990s ................................................................ 19 
`
`VII.  OVERVIEW OF THE ’393 PATENT .......................................................... 35 
`
`
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`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`VIII.  CLAIM CONSTRUCTION .......................................................................... 58 
`
`Stelter ............................................................................................................ 73 
`Independent Claim 1 ................................................................................ 73 
`
`Independent Claim 26 ............................................................................107 
`
`Quiachon .....................................................................................................115 
`Independent Claim 1 ..............................................................................115 
`
`“shape of a M” / “shape of multiple Ms” / “M configuration”
`(claims 1, 2, 26) ....................................................................................... 66 
`“endovascular apparatus” (claims 1, 26) ................................................. 68 
`“operatively connected” / “operatively coupled” (claim 1) ..................... 69 
`IX.  STELTER, QUIACHON, AND HARTLEY DISCLOSE THE
`ATTACHMENT DEVICE CLAIMED IN THE ’393 PATENT .................. 70 
`X.  GROUNDS FOR FINDING THE CHALLENGED CLAIMS INVALID ... 72 
`
`A.  Legal Principles ............................................................................................ 58 
`B.  Claims 1 and 26 – “telescoping arm” and “telescoping arms” .................... 59 
`C.  Remaining Claim Terms .............................................................................. 66 
`1. 
`2. 
`3. 
`A.  Ground I: Challenged Claims 1, 2, 4, 10, 11, and 26 are Anticipated by
`1. 
`2.  Dependent Claim 2 .................................................................................. 94 
`3.  Dependent Claim 4 ................................................................................100 
`4.  Dependent Claim 10 ..............................................................................103 
`5.  Dependent Claim 11 ..............................................................................104 
`6. 
`B.  Ground II: Challenged Claims 1, 2, 4, 11, and 26 are Anticipated by
`1. 
`2.  Dependent Claim 2 ................................................................................137 
`3.  Dependent Claim 4 ................................................................................143 
`4.  Dependent Claim 11 ..............................................................................145 
`5. 
`C.  Ground III: Challenged Claim 10 is Obvious in View over Quiachon in
`
`Independent Claim 26 ............................................................................147 
`
`view of Lau .................................................................................................154 
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`1.  Overview of Lau ....................................................................................154 
`2.  Dependent Claim 10 ..............................................................................155 
`D.  Ground IV: Challenged Claims 1, 2, 4, 10, 11, and 26 are Anticipated by
`1. 
`2.  Dependent Claim 2 ................................................................................183 
`3.  Dependent Claim 4 ................................................................................189 
`4.  Dependent Claim 10 ..............................................................................191 
`5.  Dependent Claim 11 ..............................................................................191 
`6. 
`
`Hartley ........................................................................................................161 
`Independent Claim 1 ..............................................................................161 
`
`Independent Claim 26 ............................................................................193 
`XI.  AVAILABILITY FOR CROSS-EXAMINATION .................................... 200 
`XII.  RIGHT TO SUPPLEMENT ........................................................................ 200 
`XIII.  JURAT ......................................................................................................... 201 
`
`
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`

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`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`I, Elliot L. Chaikof, declare as follows:
`I.
`INTRODUCTION
`1. My name is Elliot L. Chaikof.
`
`2.
`
`I am making this declaration at the request of Medtronic Vascular,
`
`Inc. (“Petitioner”) as an independent expert consultant in this proceeding before
`
`the United States Patent and Trademark Office and to provide testimony pertinent
`
`to Petitioner’s petition in the matter of the Inter Partes Review of U.S. Patent No.
`
`7,101,393 to Sarac (“the ’393 patent”). I understand that Petitioner is challenging
`
`claims 1, 2, 4, 10, 11 and 26 of the ’393 patent (“Challenged Claims”).
`
`II. QUALIFICATIONS AND EXPERIENCE
`3.
`I have been involved in the research and development of endovascular
`
`stent grafts, and in particular, I have 30 years of experience in both the fields of
`
`vascular and endovascular surgery and biomedical and chemical engineering. My
`
`qualifications for forming the opinions set forth in this declaration are summarized
`
`below. My curriculum vitae, which describes my education, experience,
`
`professional activities, and which lists, inter alia, my publications and patents, is
`
`attached as Appendix A.
`
`4.
`
`I was admitted into a 5 year BA-MD program at Johns Hopkins
`
`University and received my bachelor’s degree in Biology in 1979 and medical
`
`degree in 1982. This was followed by a residency in general surgery at
`
`
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`

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`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`Massachusetts General Hospital until 1991, during which time I received a Ph.D.
`
`in Chemical Engineering from the Massachusetts Institute of Technology (“MIT”)
`
`in 1989.
`
`5. After the completion of my general surgery residency at
`
`Massachusetts General Hospital, I became a resident in vascular surgery at Emory
`
`University School of Medicine. During this residency, I learned, among other
`
`things, how to treat abdominal aortic aneurysms. I note that endovascular stent
`
`grafts were in the initial development stages when I was a vascular surgery
`
`resident. My training during this residency focused on open surgery for treating
`
`abdominal aortic aneurysms. I was aware of the initial endovascular stent grafts
`
`during my residency and the research being performed in this space.
`
`6. After the completion of my residency, I joined the faculty of the
`
`Emory University School of Medicine in 1992 as an Assistant Professor of
`
`Surgery in the Division of Vascular Surgery.
`
`7.
`
`I served as a member of the core group of principal investigators that
`
`conducted the first Food and Drug Administration approved clinical trials of stent
`
`grafts for repair of abdominal and thoracic aortic aneurysms. Specifically, in 1994
`
`I initiated one of the first programs in the United States for the treatment of
`
`patients with an abdominal aortic aneurysm with an endovascular stent graft.
`
`Between 1994 and 2004, I served as the principal investigator at Emory
`
`
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`

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`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`University for clinical trials to evaluate the Ancure endograft (Endovascular
`
`Grafting System (EGS), Endovascular Technologies (EVT), Guidant, Corp.), the
`
`Excluder endograft (WL Gore, Inc.), the Talent endograft (World Medical
`
`Corp./Medtronic AVE), and the Valor endograft (Medtronic, Inc) for the
`
`treatment of patients with an abdominal aortic aneurysm. During this period, I also
`
`served as the principal investigator at Emory University for clinical trials to
`
`evaluate the Excluder thoracic endograft (WL Gore, Inc.) and the Talent™
`
`thoracic endograft (World Medical Corp./Medtronic AVE) for the treatment of
`
`patients with a thoracic aortic aneurysm. Between 1999 through 2004, I also
`
`served as Chair of several sessions on endovascular abdominal aortic aneurysm
`
`repair at the annual meeting of the Society for Vascular Surgery, the major
`
`specialty society in the field of vascular surgery. In 1999, I also served as Guest
`
`Editor for a special issue entitled “Endovascular Abdominal Aortic Aneurysm
`
`Repair: Problems and Pitfalls” in the peer-reviewed journal Seminars in Vascular
`
`Surgery.
`
`8.
`
`For over the past 30 years, I have also been a practicing vascular
`
`surgeon, performing both open and endovascular aneurysm repairs. In performing
`
`endovascular aneurysm repairs, I have used a variety of endovascular stent grafts
`
`that were designed and manufactured by various companies. Due to my
`
`involvement in clinical trials, discussed above, and by using these various
`
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`endovascular stent grafts, I have a detailed understanding regarding the design of
`
`endovascular stent grafts, how endovascular stent grafts are designed to be
`
`implanted, and how endovascular stent grafts work in the vascular system once
`
`implanted.
`
`9. Currently, I am the Johnson and Johnson Professor of Surgery at
`
`Harvard Medical School and serve as Chair of the Roberta and Stephen R. Weiner
`
`Department of Surgery and Surgeon-in-Chief at the Beth Israel Deaconess
`
`Medical Center in Boston, Massachusetts. In this role, I oversee the clinical,
`
`educational, and research programs of 15 divisions and three multi-disciplinary
`
`institutes, which include nearly 200 Harvard Medical School faculty, including
`
`over 130 employed faculty, distributed at over 25 clinical sites in both community
`
`and academic settings throughout Eastern Massachusetts. I am also a member of
`
`the faculty at Massachusetts Institute of Technology in the Harvard-MIT Division
`
`of Health Sciences and Technology and a member of the Wyss Institute of
`
`Biologically-Inspired Engineering of Harvard University.
`
`10. Further, I am the inventor of over a dozen US patents, including an
`
`endovascular device. My contributions in the fields of science, engineering, and
`
`surgery have been recognized by the receipt of the 2013 Clemson Award in
`
`Applied Research from the Society for Biomaterials and the Flance-Karl Award
`
`from the American Surgical Association, which is presented annually to a single
`
`
`
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`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`surgeon in the United States who has made a seminal contribution in basic
`
`research with application to clinical surgery. I have served as the primary advisor
`
`of approximately 16 Ph.D. students and 60 postdoctoral fellows, who are members
`
`of the faculty in departments of engineering, chemistry, materials science, and
`
`surgery, along with many who hold positions in the medical device,
`
`biotechnology, and pharmaceutical industries. I have also served as Program
`
`Director of a Residency in Vascular Surgery with responsibility for the education
`
`of many vascular surgeons who utilize endovascular devices. I have recently
`
`completed a four-year term as Vice-Chair and Chair of Section 1 (Engineering
`
`Sciences) of the National Academy of Medicine and currently serve as a member
`
`of the National Materials and Manufacturing Board Roundtable on Biomedical
`
`Engineering Materials and Applications (BEMA) of the National Academies of
`
`Science, Engineering, and Medicine, the Standing Committee on Biotechnology
`
`Capabilities and National Security Needs of the National Academies of Science,
`
`Engineering, and Medicine, and the Committee on Emerging Science,
`
`Technology, and Innovation in Health and Medicine (CESTI) of the National
`
`Academy of Medicine.
`
`11.
`
`I have served as Chair of multiple national committees that have
`
`formulated best clinical practice guidelines that impact the care of patients with an
`
`abdominal aortic aneurysm. I have also served as Chair of a national committee
`
`
`
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`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`that formulated the reporting standards for clinical trials of endovascular aortic
`
`aneurysm repair (EVAR), which continues to provide ongoing regulatory
`
`guidance to the medical device industry and the United States Food and Drug
`
`Administration. I have also been asked to serve as a member of the Circulatory
`
`System Devices Panel for the United States Food and Drug Administration to
`
`develop recommendations on the continued safety and effectiveness of
`
`endovascular stent grafts for aneurysm repair.
`
`12.
`
`I am being compensated for my work on this matter, but my opinions
`
`are based on my own views of the prior art and patented technology. My
`
`compensation is not dependent on and in no way affects the substance of my
`
`statements, opinions, or conclusions in this Declaration nor is it dependent on the
`
`outcome of this proceeding.
`
`13.
`
`I have no financial interest in the Petitioner. I similarly have no
`
`financial interest in the ’393 patent, and have had no contact with the named
`
`inventor about the ’393 patent.
`
`III. LEGAL PRINCIPLES
`14.
`I am not an attorney. For the purposes of this declaration, I have been
`
`informed about certain aspects of the law that are relevant to my opinions. My
`
`understanding of the law was provided to me by the Petitioner’s attorneys.
`
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`A.
`15.
`
`Scope of Opinion
`I have been informed and understand that the Petitioner in an inter
`
`partes review may request cancellation of claims as unpatentable only on grounds
`
`that such claims are anticipated or would have been obvious to a person of
`
`ordinary skill in the art at the time of the purported invention, and only on the
`
`basis of prior art consisting of patents or printed publications. My opinions in this
`
`matter address only such grounds.
`
`B. Anticipation
`16.
`I have been informed by counsel that a patent claim is invalid as
`
`anticipated if each element of that claim is present either explicitly or inherently in
`
`a single prior art reference. I have also been informed that, to be an inherent
`
`disclosure, the prior art reference must necessarily disclose the limitation, and the
`
`fact that the reference might possibly practice or possibly contain a claimed
`
`limitation is insufficient to establish that the reference inherently teaches the
`
`limitation.
`
`C. Obviousness
`17.
`I understand that a claim is unpatentable if it would have been obvious
`
`to a person of ordinary skill in the art at the time the alleged invention was made. I
`
`understand that a claim could have been obvious from a single prior art reference
`
`or from a combination of two or more prior art references. I understand that an
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`obviousness analysis requires an understanding of the scope and content of the
`
`prior art, any differences between the alleged invention and the prior art, and the
`
`level of ordinary skill in evaluating the pertinent art.
`
`18.
`
`I further understand that certain factors may support or rebut the
`
`obviousness of a claim. I understand that such secondary considerations include,
`
`among other things, commercial success of the patented invention, skepticism of
`
`those having ordinary skill in the art at the time of invention, unexpected results of
`
`the invention, any long-felt but unsolved need in the art that was satisfied by the
`
`alleged invention, the failure of others to make the alleged invention, praise of the
`
`alleged invention by those having ordinary skill in the art, and copying of the
`
`alleged invention by others in the field. I understand that there must be a nexus,
`
`that is, a connection, between any such secondary considerations and the alleged
`
`invention. I also understand that contemporaneous and independent invention by
`
`others is a secondary consideration tending to show obviousness.
`
`19.
`
`I further understand that a claim would have been obvious if it unites
`
`old elements with no change to their respective functions, or alters prior art by
`
`mere substitution of one element for another known in the field, and that the
`
`combination yields predictable results. Also, I understand that obviousness does
`
`not require physical combination/bodily incorporation, but rather consideration of
`
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`what the combined teachings would have suggested to persons of ordinary skill in
`
`the art at the time of the alleged invention.
`
`20. While it may be helpful to identify a reason for this combination, I
`
`understand that there is no rigid requirement of finding an express teaching,
`
`suggestion, or motivation to combine within the references. When a product is
`
`available, design incentives and other market forces can prompt variations of it,
`
`either in the same field or a different one. If a person of ordinary skill in the art
`
`can implement a predictable variation, obviousness likely bars its patentability.
`
`For the same reason, if a technique has been used to improve one device and a
`
`person of ordinary skill in the art would recognize that it would improve similar
`
`devices in the same way, using the technique would have been obvious. I
`
`understand that a claim would have been obvious if a person of ordinary skill in
`
`the art would have had reason to combine multiple prior art references or add
`
`missing features to reproduce the alleged invention recited in the claims.
`
`21.
`
`I reserve the right to respond to any allegations that may be put forth
`
`by the Patent Owner in this proceeding that any secondary considerations tend to
`
`rebut the obviousness of any claim of the ’393 patent discussed in this declaration.
`
`22.
`
`I understand that in considering obviousness, it is important not to
`
`determine obviousness using the benefit of hindsight derived from the patent
`
`being considered.
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`D. Claim Dependency
`23.
`I understand that a patent may include two types of claims,
`
`independent claims and dependent claims. An independent claim stands alone and
`
`includes only the limitations it recites. A dependent claim can depend from an
`
`independent claim or another dependent claim. I understand that a dependent
`
`claim includes all the limitations that it recites in addition to all of the limitations
`
`recited in the claim from which it depends. I understand that a multiple dependent
`
`claim is a dependent claim, which refers back to more than one preceding
`
`independent or dependent claim. I also understand that a multiple dependent claim
`
`contains in any one embodiment the limitations of the particular claim referred to
`
`for the embodiment under consideration. Thus, a multiple dependent claim is
`
`considered in the same manner as a plurality of single dependent claims.
`
`24. The analysis in this declaration is in accordance with the above-stated
`
`legal principles.
`
`IV. MATERIALS CONSIDERED
`25.
`In preparing this declaration, I reviewed and considered the materials
`
`identified in Appendix B.
`
`V. LEVEL OF ORDINARY SKILL IN THE ART
`26.
`It is my understanding that when considering the claims of the ’393
`
`patent and the prior art, I must do so based on the perspective of one of ordinary
`
`
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`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`skill in the art at the relevant effective filing date. I consider myself totally
`
`qualified as to the level of ordinary skill at the relevant time(s). My understanding
`
`is that the purported effective filing date of the ’393 patent is July 22, 2002. (See
`
`infra Section VII.B). I offer no opinion here regarding the effective filing date of
`
`the ’393 patent and whether the ’393 patent is entitled to a priority date of July 22,
`
`2002, as I understand that is a legal determination, and I am not a lawyer.
`
`27.
`
`I understand that several factors are to be considered in determining
`
`who would be a person of ordinary skill in the art. These factors include: (1) the
`
`types of problems encountered in the art; (2) the prior art solutions to those
`
`problems; (3) the rapidity with which innovations are made; (4) the sophistication
`
`of the technology; and (5) the educational level of active workers in the field.
`
`28. Based on these factors as well as my experience and expertise, a
`
`person of ordinary skill in the art in 2002 would have been either (i) a medical
`
`practitioner with experience using endovascular devices and with training,
`
`experience, or familiarity applying principles of engineering to the design,
`
`development, or testing of endovascular devices; and/or (ii) an engineer having at
`
`least a bachelor of science degree and with several years of experience in the
`
`design, development, or testing of endovascular devices and their clinical use; a
`
`higher level of education could reduce the number of years of experience required.
`
`A person of ordinary skill in the art in 2002 would have also been familiar with
`
`
`
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`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`the design and operation of endovascular stent grafts and the equipment and tools
`
`required to treat a patient using an endovascular stent graft.
`
`VI. OVERVIEW OF THE STATE OF THE ART
`A.
`The State of the Art
`1. Historical Treatment of Aneurysms
`29. The vascular system is the network of blood vessels that carry blood
`
`through a person’s body. The heart pumps blood through the vascular system, and
`
`the largest vessel in the vascular system is the aorta, which connects directly to a
`
`patient’s heart. A portion of the aorta passes through a person’s abdomen and
`
`towards his or her legs; this part of the aorta is referred to as an abdominal aorta.
`
`As the abdominal aorta approaches a person’s legs, it divides into two smaller
`
`blood vessels that allow blood to flow to a person’s legs; these blood vessels are
`
`known as the iliac arteries. The aorta and iliac arteries are shown in the image
`
`below:
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`
`(Ex.1140, Criado, et al., Early Experience with the Talent Stent-Graft System,
`
`Texas Heart Institute J., 27(2):128 (2000) (“Criado 2000”), 133 (annotated)).
`
`30.
`
`In the abdominal aorta, a vascular disease called an aneurysm may
`
`form. An aneurysm occurs when the wall of a blood vessel, such as the abdominal
`
`aorta, becomes weakened and begins to bulge and expand. As blood continues to
`
`flow through the weakened blood vessel, the aneurysm continues to grow and
`
`expand if left untreated. Significantly, if the bulge ruptures, it can cause internal
`
`bleeding that could cause death. An aneurysm that forms in the abdominal aorta is
`
`known as an abdominal aortic aneurysm (“AAA”), and can lead to death if left
`
`untreated.
`
`
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`- 13 -
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`
`31. Historically, AAAs were treated by an invasive surgical operation,
`
`sometimes referred to as “open surgery,” which dates back to at least the early
`
`1950s. (See Ex.1110, Cooley et al., Technique of “Open” Distal Anastomosis for
`
`Ascending and Transverse Arch Resection, Cardiovascular Diseases, Bulletin of
`
`the Texas Heart Institute, 8(3):421 (September 1981) (“Cooley 1981”); Ex.1111,
`
`Livesay et al., Open Aortic Anastomosis: Improved Results in the Treatment of
`
`Aneurysms of the Aortic Arch, Cardiovascular Surgery 1981, 66(2):I-122 (August
`
`1982) (“Livesay 1982”); Ex.1101, ’393 patent, 1:25-30 (“In the past aortic
`
`aneurysms were treated almost exclusively by surgical repair.”)). I note that I was
`
`originally trained to treat AAAs using this “open surgery” technique. In an “open
`
`surgery” procedure, the patient’s abdomen is cut open to access the abdominal
`
`aorta. Once the abdominal aorta is exposed, an incision is made in the abdominal
`
`aorta and a tubular, cylindrical or Y shaped, graft fabricated from a synthetic
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`polymer, such as Dacron, is sewn in to replace the segment of aorta containing the
`
`aneurysm.
`
`
`
`(Ex.1114, Open Repair of Abdominal Aortic Aneurysms (AAA), North Bristol
`
`NHS Trust (January 2018) (“Open Repair of AAA”), 4). The tubular graft creates
`
`a new artificial path for the blood to flow and prevents blood from flowing within
`
`the weakened aortic wall of the aneurysm, which has been replaced by the graft.
`
`However, this surgical technique is complicated, and carries a significant risk of
`
`mortality. There is also a risk of postoperative complications associated with this
`
`type of surgery, and as a result, this surgical technique is not suited for many
`
`
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`patients, particularly older or frail patients that have other underlying health
`
`issues.
`
`2.
`
`Alternatives to “Open Surgery” Were Pursued Since At
`Least the 1970s
`32. Because of the significant risk of mortality and complications
`
`associated with “open surgery,” industry stakeholders developed an alternative
`
`way to treat AAA. The technique, referred to as endovascular surgery, involves
`
`inserting a device, also known as a stent graft or endovascular stent graft or
`
`endograft, through a person’s blood vessels and into the AAA. More specifically,
`
`instead of being sewn into the patient, the stent graft would be inserted through a
`
`person’s femoral artery inside a hollow tube such as a catheter, and once
`
`positioned at the site of the AAA, the device would be expanded, either on its own
`
`or via a balloon, in order to extend across the aneurysm so as to create a new path
`
`for blood to flow. For the stent graft to successfully travel through a person’s
`
`blood vessels, it has to be compressed into a small profile. Otherwise, the stent
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`graft would not be able to travel through a person’s blood vessels to the AAA. The
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`stent graft, sometimes referred to as an endoluminal graft, has two primary
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`components: (1) a fabric material, which spans across the device, all or in part,
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`and (2) a frame or scaffolding structure, most often comprised of a metal in the
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`form of stents, stent-like structures, or rings. (Ex.1117, Criado et al., Abdominal
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`- 16 -
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`Aortic Aneurysm: Overview of Stent-Graft Devices, J. American College of
`
`Surgery, 194(S1):S88 (January 2002) (“Criado 2002”), S89). The fabric or graft
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`material is often a knitted or woven material, such as Dacron (Ex.1117, Criado
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`2002, S89), and the metal frame is a support structure for the device, which also
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`provides fixation of the graft to the blood vessel wall. (Ex.1117, Criado 2002,
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`S89). The stent is typically affixed to the graft by sutures (i.e., stiches). The stent’s
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`ability to act as the support structure is particularly important because it acts as a
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`scaffold and structure for the entire device; otherwise, the device might not retain
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`its shape inside the patient. Further, the stent’s ability to provide fixation ensures
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`the stent graft performs its function: ensuring a tight seal is maintained above and
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`below the AAA in order to prevent blood from flowing or leaking around the
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`device into the aneurysm sac (referred to as an endoleak), which can lead to aortic
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`rupture. The stents also anchor the stent graft to the vessel wall, preventing the
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`device from migrating or becoming dislodged as an additional means to ensure
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`that there is a single blood pathway, which precludes blood from flowing outside
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`the device and within the aneurysm sac.
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`- 17 -
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`

`

`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`
`
`33. These endovascular stent grafts have been envisioned by industry
`
`stakeholders since at least the 1970s. For example, one of the first prototypes for
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`treating AAA was developed starting in 1976 and was “[a] metallic self-
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`expanding mesh with a ‘zig zag’ configuration, covered by a thin fabric graft that
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`was compressed and introduced inside a sheath.” (Ex.1113, Parodi, Endovascular
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`Repair of Abdominal Aortic Aneurysms, Advances in Vascular Surgery 1:85
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`(1993) (“Parodi 1993”), 86). Further, a patent issued in 1979 was titled “Method
`
`for Performing Aneurysm Repair” and discloses a method of treating an aneurysm
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`- 18 -
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`

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`Chaikof Declaration
`’393 Patent, Claims 1, 2, 4, 10, 11, 26
`using an “expansion ring,” where associated anchoring pins would pierce the
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`healthy vessel walls above and below the aneurysm, creating a fluid tight seal to
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`ensure that blood would flow through the graft and seal off the aneurysm from
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`blood flow. (Ex.1115, U.S. Patent No. 4,140,126 to Choudhury (“Choudhury”),
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`3:39-4:4).
`
`34. The first successful endovascular procedure to treat AAA was
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`reported in 1991, in which a custom made stent grant was inserted through the
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`femoral artery in the patient’s leg and fixed inside the AAA using expandable
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`stents. (See Ex.1117, Criado 2002, S88).
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`3.
`
`Endovascular Stent Grafts to Treat AAA Became Well-
`Known and Available for Use in the 1990s
`35. Shortly after the first successful endovascular AAA procedures were
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`performed, the concept of treating an AAA using an endovascular stent graft
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`rapidly spread throughout the United States (and all over the world). For example,
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`there are multiple articles describing early clinical trials that took place in the
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`early 1990s where patients were successfully treated with AAA stent grafts with
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`zigzag sinusoidal stents. (See, e.g., Ex.1118,