DECLARATION OF JAMES SILVER, PH.D.
`IN SUPPORT OF PATENT OWNER’S RESPONSE TO
`PETITION FOR INTER PARTES REVIEW
`
`IPR2014-00100
`U.S. Patent 5,593,417
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................... 2
`I.
`SUMMARY OF OPINIONS ........................................................................... 4
`II.
`III. QUALIFICATIONS ........................................................................................ 5
`IV. APPLICABLE LEGAL STANDARDS .......................................................... 5
`A.
`Claim Interpretation .............................................................................. 6
`B.
`Burden of Proof ..................................................................................... 6
`C. Anticipation ........................................................................................... 6
`D. Obviousness ........................................................................................... 8
`V. ONE OF ORDINARY SKILL IN THE ART ...............................................11
`VI. RHODES ’154 PATENT ...............................................................................12
`VII. BACKGROUND OF ’417 PATENT ............................................................14
`VIII. CLAIM INTERPRETATION .......................................................................25
`IX. DOES KORNBERG ANTICIPATE THE ’417 PATENT? ..........................31
`X.
`IS THE ’417 PATENT OBVIOUS OVER KORNBERG AND RHODES
`’154? ..............................................................................................................40
`XI. SECONDARY CONSIDERATIONS OF NON-OBVIOUSNESS ..............48
`A.
`Recognition of a Problem, Long Felt But Unmet Need, and
`Failure of Others .................................................................................. 48
`Commercial Success............................................................................ 58
`B.
`Commercial Acquiescence and Licensing .......................................... 59
`C.
`XII. CONCLUSION ..............................................................................................59
`
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`I.
`
`1.
`
`INTRODUCTION
`
`I, James Silver, Ph.D., have been retained by the law firm of Friedman,
`
`Suder & Cooke, P.C. (“FSC”), on behalf of its client Endotach LLC (“Endotach”),
`
`in connection with inter partes review no. IPR2014-00100 of U.S. Patent No.
`
`5,593,417 (which I will refer to in this declaration as “the ‘417 Patent”). I
`
`understand that the Patent is owned by a trust affiliated with the family of Dr.
`
`Valentine J. Rhodes, the inventor of the ‘417 Patent, and exclusively licensed to
`
`Endotach. I understand that Endotach has sued Cook Medical, Medtronic, and
`
`others for infringement of the ‘417 Patent and that Medtronic filed the petition for
`
`inter partes review of the ‘417 Patent.
`
`2.
`
`I am being compensated at my standard hourly rate for my work on this
`
`matter, including providing this declaration. My compensation is not dependent on
`
`the outcome of this inter partes review and in no way affects the substance of my
`
`testimony in this declaration. I have no financial interest in ‘417 Patent, the
`
`Rhodes family, the trust that owns the ‘417 Patent, Endotach, any entity affiliated
`
`with the foregoing entities, or in the outcome of this inter partes review or any of
`
`the lawsuits involving the ‘417 Patent.
`
`3.
`
`I have also consulted with FSC and provided my expert analysis and
`
`opinions on behalf of Endotach in infringement litigation against Cook Medical.
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`That litigation involves the ‘417 Patent as well as Dr. Rhodes’ ‘154 Patent (which
`
`is introduced below).
`
`4.
`
`I have reviewed and am familiar with the ‘417 Patent (Ex. 1001), its
`
`prosecution history (Ex. 1002), the Second Corrected Petition for Inter Partes
`
`Review filed by Medtronic on November 12, 2013 (Paper 5) (which I will refer to
`
`in this declaration as the “Petition”), the Board’s Institution Decision in this case
`
`dated March 25, 2014 (Paper 15) (which I will refer to in this declaration as the
`
`“Institution Decision”), and at least the following documents referenced in the
`
`Petition:
`
`• U.S. Patent 4,562,596 (Ex. 1006) (which I will refer to in this
`
`declaration as “Kornberg”)
`
`• Dr. Rhodes’ U.S. Patent 5,122,154 (Ex. 1008) (which I will refer to in
`
`this declaration as “the Rhodes ‘154 Patent” or “the ‘154 Patent”)
`
`• Declaration of Mr. Travis Rowe (Ex. 1003) (which I will refer to in
`
`this declaration as the “Rowe Declaration”)
`
`• Declaration of Mr. Atul Gupta (Ex. 1004) (which I will refer to in this
`
`declaration as the “Gupta Declaration”)
`
`5.
`
`In addition, I have reviewed and am familiar with the documents I
`
`specifically cite in this declaration, as well as the following deposition transcripts:
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`• Transcript of June 26, 2014 Deposition of Mr. Travis Rowe (Ex.
`
`2023)
`
`• Transcript of June 25, 2014 Deposition of Mr. Atul Gupta (Ex. 2021)
`
`II.
`
`6.
`
`SUMMARY OF OPINIONS
`
`Based on my review and analysis of the materials in this matter, as well as
`
`my experience and education, in my opinion Kornberg does not disclose all of the
`
`limitations of independent claim 1 of the ‘417 Patent. In particular, Kornberg fails,
`
`first, to disclose the “tightly engage” aspect of claim 1 because Kornberg instead
`
`describes projections that perforate completely through an artery’s wall. Second,
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`Kornberg fails to disclose that fluid flow forces cause the projections to engage the
`
`interior surface of the artery wall at all; instead, the projections are fully engaged at
`
`deployment and do not move thereafter except possibly due to undesirable
`
`migration.
`
`7.
`
`Based on my review and analysis of the materials in this matter, as well as
`
`my experience and education, it is also my opinion that it would not have been
`
`obvious to combine the Rhodes ‘154 Patent and Kornberg to arrive at claim 1 of
`
`the ‘417 Patent. In particular, I do not believe that one of ordinary skill in the art at
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`the time when the ‘417 Patent was filed and without knowledge of the teachings of
`
`the ‘417 Patent would have had any reason to combine the teachings of Rhodes
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`‘154 and Kornberg. In addition, there would have been technical complications
`
`trying to combine the teachings of Rhodes ‘154 and Kornberg that would have
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`further discouraged one skilled in the art from attempting to combine their
`
`teachings. Finally, I believe that objective secondary considerations also
`
`demonstrate the nonobviousness of the ‘417 Patent.
`
`III. QUALIFICATIONS
`
`8. My curriculum vitae (“CV”) is attached hereto as Exhibit A and is
`
`incorporated by reference.
`
`9.
`
`I received a Ph.D. in chemical engineering from the University of
`
`Wisconsin-Madison in 1992, and I have been working as a medical device
`
`engineer since 1993. Of particular relevance here, from 1993 to 1998 I worked in
`
`the design, development, and manufacturability of vascular stent-graft products
`
`and catheter delivery systems for W.L. Gore & Associates, Inc. (“Gore”).
`
`10.
`
`I have published 16 research papers in leading scientific journals, and I have
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`been awarded 13 United States patents as an inventor or co-inventor.
`
`IV. APPLICABLE LEGAL STANDARDS
`
`11.
`
`I will not offer opinions on principles of law as I am not an attorney.
`
`Nonetheless, I have been informed by counsel for Endotach of the following
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`principles concerning patentability, and I have used these principles as a
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`framework in arriving at my opinions stated in this declaration.
`
`A. Claim Interpretation
`
`12.
`
`I understand that a patentability analysis is performed in two steps. First, the
`
`patent claims are interpreted to ascertain their scope. Second, the interpreted
`
`claims are compared to the prior art references.
`
`13.
`
`I understand that during an inter partes review the Patent & Trademark
`
`Office (PTO) gives patent claims their broadest reasonable interpretation in light of
`
`the specification. I also understand that this interpretation is from the vantage of
`
`one of ordinary skill in the art at the time of the patent’s effective filing date.
`
`B.
`
`Burden of Proof
`
`14.
`
`I understand that the claims in an issued patent are not presumed to be valid
`
`during an inter partes review, and that the petitioner has the burden to show that a
`
`patent claim is not patentable by the preponderance of the evidence.
`
`C. Anticipation
`
`15.
`
`I understand that a patentability challenge based on section 102 of the patent
`
`law is made when a single item of prior art – a printed publication or a product –
`
`reads on every limitation found in at least one claim, thus “anticipating” the claim.
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`16.
`
`I understand that for anticipation to exist there must be no difference
`
`between the claimed invention and the reference disclosure, as viewed by a person
`
`of ordinary skill in the field of invention.
`
`17.
`
`I understand that anticipation requires that each element of the claim at issue
`
`be found, either expressly or under principles of inherency, in a single prior art
`
`reference.
`
`18.
`
`I understand that invalidity by anticipation requires that the four corners of a
`
`single prior art reference describe every element of the claimed invention, either
`
`expressly or inherently, such that a person of ordinary skill in the art could practice
`
`the invention without undue experimentation.
`
`19. However, I also understand that anticipation requires more than simply
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`locating each element within the four corners of a single document, but must also
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`disclose those elements arranged as in the claim to show prior invention.
`
`20. When prior art discloses a range of values that overlaps with a claimed
`
`range, then the prior art is said to anticipate the claimed range only if the prior art
`
`range discloses the claimed range with “sufficient specificity.” What constitutes a
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`“sufficient specificity” is fact dependent. If the claims are directed to a narrow
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`range, and the reference teaches a broader range, other facts of the case must be
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`considered when determining whether the narrow range is disclosed with
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`“sufficient specificity” to constitute an anticipation of the claims.
`
`D. Obviousness
`
`21.
`
`I understand that for a patented invention to be obvious under section 103 of
`
`the patent law, the challenger must identify prior art references that alone or in
`
`combination would have rendered the claimed invention obvious to one of ordinary
`
`skill in the art at the time of the invention.
`
`22. For a claim to be found obvious, every claim limitation must be found
`
`present in the combination of the prior art references before the obviousness
`
`analysis proceeds.
`
`23.
`
`I understand that the factors that should be assessed in the obviousness
`
`analysis include at least: (1) the scope and content of the prior art; (2) the
`
`differences between the prior art and the claim at issue; (3) the level of ordinary
`
`skill in the art; and (4) objective evidence as indicia of nonobviousness.
`
`24.
`
`I further understand that the obviousness inquiry must guard against slipping
`
`into use of hindsight and resist the temptation to read into the prior art the
`
`teachings of the invention at issue. Isolated elements from the prior art should not
`
`be picked and chosen and then combined using the invention as a blueprint if such
`
`a combination would not have been obvious at the time of the invention.
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`25.
`
`It is my understanding that a reason must be shown that would have
`
`prompted a person of ordinary skill in the art to combine known elements in the
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`fashion claimed by the patents at issue. Combinations on obviousness grounds
`
`cannot be sustained by mere conclusory statements; instead, there must be some
`
`articulated teaching, suggestion, or motivation with some rational underpinning to
`
`support the legal conclusion of obviousness.
`
`26.
`
`I understand that prior references as a whole need to be considered,
`
`including aspects that teach away from a claimed invention which may rebut
`
`showing of obviousness.
`
`27.
`
`I also understand that if a combination of two or more prior art references
`
`are used to render a claimed invention obvious, there must be a reasonable
`
`expectation of success in making or practicing the claimed invention based on such
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`combination. The combination cannot modify a prior art reference such that it
`
`would render the reference unsatisfactory for its intended purpose or change the
`
`principle of operation of the reference.
`
`28.
`
`I understand that it is impermissible to use the patent as a template (and
`
`reason) for combining prior art references as that would be applying hindsight.
`
`The ordinary skilled artisan would have to be motivated to combine references to
`
`create the combination of features required by the patent independent of the patent.
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`29.
`
`In addition, I understand the obviousness analysis cannot discount at the
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`time of invention, the inventor’s insights, and willingness to confront and
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`overcome obstacles, and even serendipity where the pathway to the invention
`
`seems to follow the logical steps to produce these patented properties.
`
`30.
`
`I understand that in making a determination on obviousness, one must also
`
`consider secondary considerations or objective evidence that may indicate
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`nonobviousness. I understand that these secondary considerations help illuminate
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`the subjective determination involved in the hypothesis used to draw the legal
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`conclusion of obviousness based upon the first three obviousness inquiries.
`
`31.
`
`It is my understanding that objective considerations focuses attention on
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`economic and motivational issues rather than technical issues, and is therefore
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`more judicially cognizable in assessing patent validity than are the highly technical
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`facts often present in patent litigation. I also understand that objective
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`considerations may be the most pertinent, probative, and revealing evidence
`
`available to the decision maker in reaching a conclusion about obviousness. Under
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`certain circumstances,
`
`the evidence of secondary considerations may be
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`particularly strong and entitled to such weight that it may be decisive.
`
`32.
`
`I understand that examples of secondary considerations that must be
`
`considered as part of an obviousness inquiry include:
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`(1) The invention’s commercial success - Were products covered by the
`claim commercially successful due to the merits of the claimed
`invention rather than due to advertising, promotion, salesmanship, or
`features of the product other than those found in the claim?
`
`
`(2) Long felt but unresolved needs - Was there long felt need for a
`solution to the problem facing the inventors, which was satisfied by
`the claimed invention?
`
`
`(3) The failure of others - Did others try, but fail, to solve the problem
`solved by the claimed invention?
`
`
`(4)
`
`Skepticism by experts - Did experts and those skilled in the art
`express skepticism that a particular solution would solve the problem
`with which the art was faced?
`
`Praise by others - Did others in the field praise the claimed invention?
`
`
`(5)
`
`(6) Unexpected results - Did the claimed invention achieve unexpectedly
`superior results over the closest prior art?
`
`
`(7) Recognition of a problem – Was the problem or the source of the
`problem solved by the claimed invention known in the art?
`
`
`(8) Copying of the invention - Did others copy the claimed invention?
`
`(9) Commercial acquiescence and licensing - Did others accept licenses
`under the patent because of the merits of the claimed invention,
`attempt to design around the invention, or simply refraining from
`action?
`
`
`V. ONE OF ORDINARY SKILL IN THE ART
`
`33.
`
`I have considered what was reasonably known by one of ordinary skill in the
`
`art as of the filing date of the ‘417 Patent, which I understand to be November 27,
`
`1995.
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`34.
`
` In this case, a person of ordinary skill in the art would be a medical device
`
`engineer or similar professional with at least an undergraduate degree in
`
`engineering and experience with vascular stent, endovascular graft and/or stent
`
`graft design, or an interventional radiologist or vascular surgeon, or a physician
`
`with at least two years of experience with stent, graft and/or stent graft technology.
`
`This person of ordinary skill in the art would understand the basic physical and
`
`structural components of a stent graft, the practical application of stent grafts in
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`aortic artery and thoracic artery repair, and at least some knowledge of the
`
`characteristics of products available from various vendors in past and current stent
`
`graft markets. I consider myself to be a person skilled in the art relative to the ‘417
`
`Patent. In November 1995, I was a Senior Project Engineer at Prograft Medical
`
`(later acquired by Gore) working on endovascular stent-grafts, and therefore had
`
`firsthand knowledge of the level of ordinary skill in the art at that time. As a
`
`person of skill in the art, I have an understanding of stent grafts and stent graft
`
`technology related to medical devices used to keep open human blood vessels and
`
`arteries.
`
`VI. RHODES ’154 PATENT
`
`35.
`
`It is my understanding that Dr. Rhodes, the inventor of the ‘154 Patent, was
`
`a thriving vascular surgeon in Bricktown, New Jersey from the 1960’s - 1990’s.
`
`He spent many years of his career performing carotid endarterectomy procedures,
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`which involved making a longitudinal incision from the common to the internal
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`carotid artery to remove plaque from the inside of the artery. Based on his
`
`experience performing this procedure, he noticed that closure of the incision
`
`allowed for the possibility of narrowing of the artery from fibrointimal hyperplasia,
`
`resembling the stenosis for which the surgery was originally performed to address.
`
`(See Rhodes, Valentine J., “Expanded Polytetrafluoroethylene Patch Angioplasty
`
`in Carotid Endarterectomy,” J. Vascular Surgery 1995, 22:724-31 (Ex. 2003).) As
`
`described in that article, by the late 1980s, Dr. Rhodes had perfected a carotid
`
`artery patching technique that minimized the effect of fibrointimal hyperplasia and
`
`restenosis, maintaining arterial lumen diameter after the procedure. With that
`
`success under his belt with surgical repair of carotid disease, Dr. Rhodes began
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`developing the idea for an innovative stent graft design for intraluminal treatment
`
`of carotid disease that would eventually become the ‘154 Patent.
`
`36. On August 15, 1990, the patent application resulting in the ‘154 Patent was
`
`filed with the U.S. Patent Office.
`
`37. The ‘154 Patent focuses on solving fundamental structural problems with
`
`prior endovascular graft devices, such as being able to use a graft over long
`
`sections of tortuous human arteries to bypass an aneurysm. Specifically, the ‘154
`
`Patent teaches an endovascular bypass graft with multiple stents along its length
`
`which serve to provide structural support and to hold the graft open against the
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`vessel wall while at the same time providing improved flexibility over earlier fully
`
`stented endovascular grafts. This improved flexibility was due to the stents being
`
`separate and spaced apart.
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`38. These benefits provided a substantial upgrade over the prior art stent graft
`
`designs, particularly in the areas of the flexibility of the graft, as well as the ability
`
`to conform the graft to different sizes depending on the patient’s anatomy.
`
`39. The graft described in the ‘154 Patent was intended to be secured in place
`
`against the wall by the multiple spaced apart stents, but also contemplated the use
`
`of other features to aid in holding the graft in place. These other features include
`
`the use of small protuberances that project slightly outward from the surface of the
`
`graft to act as small pressure points that impact the vessel wall, which would help
`
`maintain the graft’s position, or alternatively, use of small pieces of mesh placed
`
`on the outer surface of the graft to grow into contact with the vessel wall. (See
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`’154 Patent 7:18-36.) The ‘154 Patent does not describe that the protuberances
`
`penetrate at all into the interior surface of a vessel wall.
`
`VII. BACKGROUND OF ’417 PATENT
`
`40.
`
`It is my understanding that Dr. Rhodes continued to address problematic
`
`areas in the stent graft field after he received his ‘154 Patent. As Dr. Rhodes began
`
`developing what would become the subject matter of the ’417 Patent in 1995, he
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`focused on how the then-current stent graft devices were being secured to the
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`vessel wall. Dr. Rhodes noticed that the prior art devices were designed with
`
`attachment mechanisms that could ultimately lead to significant problems,
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`including tearing of the patient’s arterial wall or perforation of the arterial wall that
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`could disrupt the structure of the arterial wall and potentially cause hemorrhaging
`
`or damage to surrounding organs, such as the duodenum and the renal vein or
`
`causing an aorto-enteric fistula or an aorto-caval fistula. Based on the specification
`
`and claims that were included in the ‘417 Patent, it is apparent that Dr. Rhodes
`
`understood the prior art in this space, examined the problem of stent graft
`
`retention, and sought to provide an improved anchoring mechanism in order to
`
`prevent the problem of graft migration after deployment, while at the same time
`
`avoiding damage to the vessel wall and surrounding organs.
`
`41. The ‘417 Patent specification discusses in detail the problem the stent graft
`
`industry was facing at the time of Dr. Rhodes’s invention and how his
`
`development would solve it. Generally, in conventional vascular bypass surgery,
`
`grafts are typically secured in place by suturing the ends of the graft to the walls of
`
`the vessel. However, in an intraluminal endovascular procedure (like that
`
`anticipated by Dr. Rhodes in the ‘154 Patent), the medical practitioner inserts the
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`graft percutaneously and does not have open surgical access to the vessel to allow
`
`for suturing. This limitation led to a need for a graft to not only be placed in the
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`lumen of the blood vessel, but for the graft to remain where the practitioner
`
`inserted it.
`
`42. When the first endovascular grafts were being developed and for some time
`
`thereafter, early developers often held the belief that the grafts could be held in
`
`place by radial outward pressure and friction generated from a stent or a series of
`
`stents located at one or more locations along the length of the graft, which is
`
`referred to as passive fixation. Other early endovascular graft developers believed
`
`that some type of anchoring was required, often referred to as active fixation,
`
`which utilized various types of staples, barbs or hooks at one or more locations
`
`along the graft to affix the graft in place. With either of these types of graft
`
`securement, the stents or anchors were affixed to the wall of the vessel during
`
`deployment of the graft.
`
`43. The specification of the ‘417 Patent recognizes that these types of methods
`
`for anchoring the stent graft to the patient’s artery wall existed prior to Dr.
`
`Rhodes’s invention:
`
`Various U.S. Patent Nos. have disclosed devices for
`intraluminar location and securement, which devices
`include plural projections for effecting such securement,
`such as: 5,167,614 (Tessman et al.); 5,207,695 (Trout
`III); 5,275,622 (Lazarus et al); 5,306,286 (Stack et al.);
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`5,383,892 (Cardon et al.); 5,387,235 (Chuter); 5,397,345
`(Lazarus); and 5,423,885 (Williams).
`
`
`(‘417 Patent 3:28-34.) Representative figures from these exemplar prior art
`
`references are shown below:
`
`2005 at 6:27-32).
`
`:56-60).
`
`2006 at
`
`2007 at 2:22-28).
`
`2004 at 2:
`
`2008 at 2:62-65).
`
`20-22).
`
`2009 at 10:
`
`2010 at 5:48-50).
`
`2:12-17).
`
`2011 at
`
`
`
`
`
`These prior art references, which are Exhibits 2003 - 2011, disclose a multitude of
`
`shapes, including “hook-like projections,” “barbs,” “tine-like members with sharp
`
`points,” “protrusions” and “teeth.” However, Dr. Rhodes saw an opportunity for
`
`improvement, stating in his patent that “[w]hile such anchoring means are believed
`
`to be effective for their intended purpose, they never the less appear to be
`
`amenable to improvement insofar as graft retention is concerned.” (‘417 Patent
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`3:24-27.)
`
`44. These prior art anchoring mechanisms, derived from the concept of suturing
`
`a graft into position, focused on the problem of embedding anchors in the wall of
`
`the artery immediately upon deployment of the device in order to affix the grafts in
`
`place. Anchors designed in this fashion utilize the radial outward force exerted by
`
`a balloon or by a self-expanding stent to engage and penetrate the vessel wall.
`
`However, these mechanisms did not consider the influence that body forces would
`
`exert on the device after deployment. Sometimes, these anchors worked against
`
`the natural forces within the vasculature, and could either result in the anchors
`
`damaging or tearing the vessels as they were pushed deeper into the tissue, or
`
`could result in fatigue fracture of the anchors due to pulsatile and shear flow forces
`
`acting on the graft. As a result of anchor fracture, for example as occurred with the
`
`AnCure endograft, the crude attachment mechanisms of these grafts could allow
`
`migration.
`
`45.
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`In the ‘417 Patent, Dr. Rhodes set out not to improve the fixation of the stent
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`graft device to the vessel wall upon deployment, but instead focused on a new
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`method of attachment which would focus on countering migration forces. As
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`explained in the specification of the ‘417 Patent, Dr. Rhodes recognized the
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`phenomenon ahead of his peers that migration of a stent graft within a blood vessel
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`after it has been deployed occurs due to the shear forces from the blood flow
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`exerted on the graft and the pulsatile expansion and contraction of the vessel.
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`Specifically, in the “Background of The Invention” section of the specification, Dr.
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`Rhodes described
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`this problem
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`in
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`the stent graft market, noting
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`that
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`“[n]otwithstanding the foregoing, a need exists for means for ensuring good
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`retention from migration for intraluminal grafts.” (‘417 Patent 3:35-37.) Dr.
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`Rhodes then went on to explain how the invention described in the ‘417 Patent
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`would utilize the blood flowing through the graft to exert longitudinal and radial
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`forces onto his designed anchors for providing a tight engagement with the wall so
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`that unwanted migration could be prevented:
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`(‘417 Patent 8:11-45.)
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`46. This was an important advancement, especially when viewed against the
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`contemporary options at the time. A critical difference between Dr. Rhodes’
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`invention and the prior art is the location, direction, orientation (angle), and height
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`of the anchors used to prevent migration, specifically in relation to the direction of
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`the blood flowing through the vessel. Dr. Rhodes recognized that it would not be
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`possible to control the depth of penetration of the anchors with complete certitude
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`due to a number of variables. Such variables include variances in the amount of
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`force applied to the barbs from the blood flow, the thickness of the vessel wall
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`between different patients and in different locations within the vessel, and the
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`thickness and hardness of plaque that has built up at different locations on the
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`interior of the vessel wall, as well as the curvature of the vessel and the pulsatile
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`expansion and contraction of the vessel. However, by focusing on the location,
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`direction, orientation (angle), and height of the anchors, one could design anchors
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`that would achieve the desired amount of engagement and penetration for
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`securement of the device against migration, but which would only penetrate the
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`vessel wall to the degree necessary to counter the caudal downstream migration
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`forces being exerted on the device post deployment.
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`47. As will be discussed in detail below, Kornberg focuses on anchors that fully
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`engage the vessel wall to provide the necessary attachment to fix the device in
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`place immediately upon completion of the device’s deployment, as would be the
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`case with sutures. Such anchors that undergo full attachment during deployment
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`would not experience any further gain in migration resistance as a result of the
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`blood flow forces. Rather, the blood flow forces would either have no effect on the
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`amount of securement provided by the anchors or force the anchors to further
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`penetrate the vessel such that there would be an increased risk of damage to the
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`vessel wall, or it may exert a force on the anchor that could result in damage to the
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`anchor itself. (See M. Malina, I. Krasnodar et al., “Endovascular AAA Exclusion:
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`Will Stents With Hooks and Barbs Prevent Stent-Graft Migration?,” J
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`Endovascular Surgery 1998, 5:310-317 (Ex. 2012, which I will refer to herein as
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`the “Malina Article”).) For instance, if the anchor is forced to penetrate more
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`deeply into the vessel wall, it risks damage to the integrity of the structure of the
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`vessel wall which could lead to dissection or cause perforation of the vessel wall
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`and possibly cause hemorrhaging or damage surrounding organs, if it had not done
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`so already upon deployment. If the anchor has reached, or is near, its full level of
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`penetration upon deployment, additional downstream forces could cause the vessel
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`wall to rupture, due to the creation of a longitudinal rip or tear in the vessel wall.
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`If the vessel wall does not tear under the additional downstream shear forces from
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`the blood flow, a torque would be exerted on the anchor that could cause the
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`anchor to invert or fracture. In either case the anchor would no longer be effective
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`for its purpose of securing the device in place.
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`48. However, Dr. Rhodes was focused on the effect these prior art anchoring
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`mechanisms had on the vessel wall after deployment. Dr. Rhodes demonstrated
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`the importance of this concept to his invention throughout the claims and the
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`prosecution history of the ‘417 Patent.
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`49. For example, in claim 1, the ‘417 Patent requires “…whereupon the force
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`applied to said tubular member by the fluid flowing through said passageway
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`produces on each of said projections a force component to cause said at least one
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`surface to tightly engage the interior surface of the vessel, duct, or lumen to fixedly
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`secure said device in place.” (‘417 Patent 9:40-46.) Dr. Rhodes contemplated that
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`his newly designed anchoring projections, by using the natural forces provided by
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`the blood flowing through the graft, would, if needed, allow the graft to secure
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`itself post-deploymen