`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`__________
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`__________
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`
`
`MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.
`Petitioners
`
`v.
`
`MARITAL DEDUCTION TRUST
`Patent Owner
`
`
`__________
`
`
`
`Case IPR2014-00100
`Patent 5,593,417
`
`
`__________
`
`
`
`PATENT OWNER’S RESPONSE
`TO PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`

`

`Case No. IPR2014-00100
`Patent No. 5,593,417
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`
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`TABLE OF CONTENTS
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 2
`
`A. Dr. Rhodes’s Early Artery Repair Work ............................................... 2
`
`B.
`
`C.
`
`D.
`
`The Rhodes ’154 Patent ........................................................................ 2
`
`The ’417 Patent Under Review ............................................................. 4
`
`The Industry’s Use of Dr. Rhodes’s Ideas and the Implicit
`Acknowledgement of the Importance of its Benefits .......................... 17
`
`E.
`
`Level of Ordinary Skill in the Art ....................................................... 22
`
`III. CLAIM INTERPRETATION ....................................................................... 25
`
`A.
`
`B.
`
`“At Least One Surface” and “Said At Least One Surface”................. 25
`
`“Engagement With,” “Engaging,” and “To Tightly Engage the
`Interior Surface of the Vessel, Duct, or Lumen to Fixedly
`Secure Said Device in Place.” ............................................................. 26
`
`IV. KORNBERG DOES NOT ANTICIPATE CLAIMS 1, 2, 9, 10, AND
`13 OF THE ’417 PATENT. ........................................................................... 31
`
`A. Overview of Kornberg......................................................................... 31
`
`B.
`
`C.
`
`Fluid Flow Force Does Not Cause Kornberg’s Hooks to Engage
`at All, as They Fully Engage Upon Deployment. ............................... 34
`
`Kornberg’s Hooks do Not “Tightly Engage” Because They
`Puncture the Artery Wall. .................................................................... 36
`
`V.
`
`RHODES ’154 AND KORNBERG DO NOT RENDER CLAIMS 1,
`2, 9, 10, AND 13 OBVIOUS. ........................................................................ 39
`
`A. Kornberg is a Deficient Secondary Reference. ................................... 40
`
`B.
`
`There is No Motivation or Other Legally Sufficient Rationale to
`Combine Rhodes ’154 and Kornberg. ................................................. 42
`
`Response
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`Page ii
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`Case No. IPR2014-00100
`Patent No. 5,593,417
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`C.
`
`D.
`
`E.
`
`F.
`
`The Understanding of the Art Taught Away From the Proposed
`Modification. ....................................................................................... 46
`
`The Obviousness Contention is Tainted by Impermissible
`Hindsight. ............................................................................................ 47
`
`Replacement of Rhodes ’154’s Protuberances With Kornberg’s
`Hooks Would Render Rhodes ’154 Unsatisfactory for its
`Intended Purpose and Change its Principle of Operation. .................. 49
`
`Secondary Considerations Demonstrate the Nonobviousness of
`the Invention. ....................................................................................... 51
`
`1.
`
`2.
`
`3.
`
`Recognition of a Problem, Long-Felt But Unmet Need,
`and Failure of Others ................................................................ 51
`
`Commercial Success ................................................................. 55
`
`Commercial Acquiescence and Licensing ................................ 55
`
`VI. CONCLUSION .............................................................................................. 56
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`
`
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`Response
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`Page iii
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`Case No. IPR2014-00100
`Patent No. 5,593,417
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`
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`TABLE OF AUTHORITIES
`
`Cases
`
`Atofina v. Great Lakes Chem. Corp., 441 F.3d 991 (Fed. Cir. 2006) ..................... 39
`
`Bettcher Indus., Inc. v. Bunzl USA, Inc., 661 F.3d 629 (Fed. Cir. 2011) ................ 38
`
`Bicon, Inc. v. Straumann Co., 441 F.3d 945 (Fed. Cir. 2006) ................................. 26
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed.
`Cir. 2009) ............................................................................................................ 46
`
`Elekta Instrument S.A. v. O.U.R. Sci. Int’l, Inc., 214 F.3d 1302 (Fed. Cir.
`2000) ................................................................................................................... 27
`
`In re Fine, 837 F.2d 1071 (Fed. Cir. 1988) ............................................................. 39
`
`In re Gordon, 733 F.2d 900 (Fed. Cir. 1984) .......................................................... 51
`
`Graham v. John Deere Co., 383 U.S. 1 (1966) ....................................................... 47
`
`Gubelmann v. Gang, 408 F.2d 758 (C.C.P.A. 1969) ............................................... 38
`
`Hewlett-Packard Co. v. MCM Portfolio, LLC, IPR2013-00217, Paper 10
`(Sept. 10, 2013) ................................................................................................... 44
`
`In re Kahn, 441 F.3d 977 (Fed. Cir. 2006) .............................................................. 42
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) .......................................... 42, 48
`
`Monroe Auto Equip. Co. v. Heckethorn Mfg. & Supply Co., 332 F.2d 406
`(6th Cir. 1964) ..................................................................................................... 48
`
`Oakley, Inc. v. Sunglass Hut Int’l, 316 F.3d 1331 (Fed. Cir. 2003) ........................ 44
`
`Tempo Lighting, Inc. v. Tivoli, LLC, 742 F.3d 973 (Fed. Cir. 2014) ...................... 29
`
`Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292 (Fed. Cir. 2002) .............. 38
`
`
`
`
`
`
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`Response
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`Page iv
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`Case No. IPR2014-00100
`Patent No. 5,593,417
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`
`Statutes
`
`35 U.S.C. § 102 ........................................................................................................31
`
`35 U.S.C. § 103 ........................................................................................................39
`
`35 U.S.C. § 316(a)(8) ................................................................................................. 1
`
`
`Rules
`
`37 C.F.R. § 42.120 ..................................................................................................... 1
`
`37 C.F.R. § 42.65 .....................................................................................................44
`
`
`Other Authorities
`
`MPEP § 2143(G) ......................................................................................................43
`
`MPEP § 2143.01(V) .................................................................................................51
`
`MPEP § 2143.03 ......................................................................................................39
`
`
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`Response
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`Page v
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`I.
`
`INTRODUCTION
`
`Pursuant to 35 U.S.C. § 316(a)(8) and 37 C.F.R. § 42.120, the Patent Owner
`
`hereby provides a Response to the Petition for Inter Partes Review filed on
`
`November 6, 2013 and last corrected on November 12, 2013, and the challenges
`
`therein for which trial has been instituted by the Board’s March 25, 2014
`
`Institution Decision (Paper 15).
`
`The only challenges for trial are whether (1) U.S. Patent No. 4,562,596 (Ex.
`
`1006, herein “Kornberg”) anticipates claims 1, 2, 9, 10 and 13 of the ’417 Patent
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`and (2) U.S. Patent No. 5,122,154 (Ex. 1008, herein “Rhodes ’154” or “’154
`
`Patent”) in view of Kornberg render the same claims obvious. As explained herein
`
`and in the accompanying declaration of Dr. James Silver, Ph.D. (Ex. 2002, herein
`
`“Silver Decl.”), both challenges fail. The anticipation challenge fails for two
`
`reasons. First, Kornberg fails to disclose that fluid flow forces cause projections to
`
`engage at all after deployment, as required by independent claim 1; instead,
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`Kornberg’s graft’s projections fully engage to their intended position upon
`
`deployment. Second, Kornberg’s projections do not satisfy the “tightly engage the
`
`interior surface of the vessel . . .” limitation because those projections perforate all
`
`the way through the vessel wall. The obviousness challenge also fails for many
`
`reasons, including, for example, lack of motivation or other legally sufficient
`
`rationale to combine the teachings of Rhodes ’154 and Kornberg. The only
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`Response
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`Page 1 of 56
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`motivation put forward by the Petition is prevention of downstream migration, but
`
`that problem was unrecognized in the art until after the ’417 Patent. As a result,
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`the obviousness challenge is tainted by hindsight, as well as other flaws.
`
`Secondary objective factors also weigh in favor of nonobviousness in this case.
`
`II. BACKGROUND
`
`A. Dr. Rhodes’s Early Artery Repair Work
`
`Dr. Rhodes, the inventor of the ’417 Patent, was a thriving vascular surgeon
`
`in Bricktown, New Jersey from the 1960s - 1990s. He spent many years of his
`
`career performing carotid endarterectomy procedures, which involved making a
`
`longitudinal incision from the common to the internal carotid artery to remove
`
`plaque from the inside of the artery. (Silver Decl. ¶ 35.) 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 that the surgery was originally performed to address. (See Ex. 2003,
`
`Rhodes, Valentine J., “Expanded Polytetrafluoroethylene Patch Angioplasty in
`
`Carotid Endarterectomy,” J. Vascular Surgery 1995, 22:724-31.)
`
`B.
`
`The Rhodes ’154 Patent
`
`By the late 1980s, Dr. Rhodes had perfected a carotid artery patching
`
`technique that minimized the effect of fibrointimal hyperplasia and restenosis,
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`Response
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`Page 2 of 56
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`Case No. IPR2014-00100
`Patent No. 5,593,417
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`maintaining arterial lumen diameter after the procedure. (See id.) After his
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`successful experience in the surgical repair of carotid disease, Dr. Rhodes
`
`developed the idea for an innovative stent graft design for intraluminal treatment of
`
`carotid disease that would eventually become the Rhodes ’154 Patent. The ’154
`
`Patent focuses on solving fundamental structural problems of prior endovascular
`
`graft devices, such as being able to use a graft over long sections of tortuous
`
`human arteries to revascularize segments of stenosis or occlusion, or to bypass an
`
`aneurysm.
`
` (’154 Patent 2:67-3:2, 3:47-52, 3:62-68; Silver Decl. ¶ 37.)
`
`Specifically, the ’154 Patent teaches an endovascular bypass graft with multiple
`
`stents along its length that serve to provide structural support, while at the same
`
`time, providing improved flexibility over earlier fully-stented endovascular grafts
`
`due to the separate and spaced-apart stents. (’154 Patent Fig. 1; Silver Decl. ¶ 37.)
`
`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. (’154 Patent 7:18-36; Silver Decl. ¶
`
`39.) 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
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`alternatively, use of small pieces of mesh placed on the outer surface of the graft to
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`Response
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`Page 3 of 56
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`Patent No. 5,593,417
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`grow into contact with the vessel wall. (See ’154 Patent 7:18-36, Silver Decl. ¶
`
`39.).
`
`C. The ’417 Patent Under Review
`
`Dr. Rhodes continued to address problematic areas in the stent graft field
`
`after he received his ’154 Patent, shifting his focus to improvements in how the
`
`then-existing stent graft devices were being secured to the vessel wall. As Dr.
`
`Rhodes began developing what would become the subject matter of the ’417 Patent
`
`in 1995, he noticed that the prior art devices were designed with attachment
`
`mechanisms that could ultimately lead to significant problems, such as tearing of
`
`the patient’s arterial wall or perforation of the arterial wall that could potentially
`
`cause hemorrhaging or damage to surrounding organs. (’417 Patent 3:53-57;
`
`Silver Decl. ¶ 40.) Dr. Rhodes 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.
`
`(’417 Patent 7:17-32, 8:12-30; Silver Decl. ¶ 40.)
`
`The ’417 Patent specification specifically discusses the problem the stent
`
`graft industry was facing at the time of Dr. Rhodes’s invention and how his
`
`development would solve it. (’417 Patent 3:21-58; Silver Decl. ¶ 41.) Generally,
`
`in conventional vascular bypass surgery (the precursor to today’s intraluminal
`
`procedures) grafts are secured in place by suturing the ends of the graft to the walls
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`Response
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`Page 4 of 56
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`Case No. IPR2014-00100
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`of the vessel. (Silver Decl. ¶ 41.) However, in an intraluminal endovascular
`
`procedure (like anticipated by Dr. Rhodes in the ’154 Patent), the medical
`
`practitioner inserts the graft percutaneously and does not have open surgical access
`
`to the vessel to allow for suturing. This restriction led to a need for a graft to not
`
`only be placed in the lumen of the blood vessel, but for the graft to remain where
`
`the practitioner inserted it. (’417 Patent 1:64-2:14; Silver Decl. ¶ 41.)
`
`When the first endovascular grafts were being developed, developers often
`
`believed that grafts could be held in place by tissue ingrowth into the graft and
`
`around the stents. (Silver Decl. ¶ 42.) Other practitioners believed that radial
`
`outward pressure and friction generated from a stent, or a series of stents, located
`
`along the length of the graft were adequate to hold the graft in place. This concept
`
`is referred to as passive fixation. (Id.) Still other developers believed that some
`
`type of anchoring was required which utilizes various types of staples, barbs or
`
`hooks at one or more locations along the graft to affix the graft in place. (Id.) This
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`concept is referred to as active fixation. (Id.)
`
`The specification of the ’417 Patent specifically recognizes that various
`
`active fixation mechanisms 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
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`Response
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`Page 5 of 56
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`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.);
`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:
`
`
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`Response
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`Page 6 of 56
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`Case No. |PR2014-00100
`Case No. IPR2014-00100
`Patent No. 5,593,417
`Patent No. 5,593,417
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`5,275,622 (Lazarus et al.) 5,306,286 (Stack et aL)
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`165 Mi
`
`% €52
`
`my. 12
`
`
`
`“[E]acl1 of the hook-like
`elements 161 has been
`
`“More particularly. the present
`invention is directed to an
`
`
`
`
`5,387,235 Chute-1'
`
`provided with a barb 162 which
`extends outwardly fiom the
`main body .
`.
`.
`(EX. 2006 at
`
`absorhable
`
`stent for placement at the locus
`of a stenotic lesion .
`.
`.
`(Ex.
`
`10 :56-60).
`
`2007 at 2:22-28).
`
`5,383,892 Cordon et all.
`
`
`
`
`
`“The spring assembly 6 on the
`“By defomling so—outward
`distal (upstream) end of the
`opening- the ends sink
`graft 1 has small surgical baths
`slightly into the wall of the
`10 firmly attached to the spring
`parts of the body Where the
`assembly 6." (Ex- 2009 at 10:
`stent is implanted- hence
`nnpro‘t-‘ing the anchoring.“
`20-22).
`
`(Ex. 2008 at 2:62-65).
`
`Response
`Response
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`Page 7 of 56
`Page 7 of 56
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`These prior art references 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 over these
`
`devices, stating in his patent, “While 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.” (Id. 3:24-27.)
`
`All of these prior art anchoring mechanisms, derived from the concept of
`
`suturing a graft into position, have one thing in common: Each 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. (Silver Decl. ¶ 44.)
`
`Anchors designed in this fashion utilize manual forces exerted by the practitioner,
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`Response
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`Page 8 of 56
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`such as the radial outward force exerted by a balloon, and/or forces exerted by the
`
`stents themselves, such as a self-expanding stent, for the anchor to engage and
`
`penetrate the vessel wall. (Id.) However, these anchoring mechanisms did not
`
`take into account the influence that body forces would exert on the device after
`
`deployment. (Id.) 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.
`
`(Id.)
`
`In the ’417 Patent, Dr. Rhodes set out not to improve the fixation of the stent
`
`graft device to the vessel wall upon deployment but instead focused on a new
`
`method of attachment that would utilize natural migration forces to keep the device
`
`in place. As explained in the specification of the ’417 Patent, Dr. Rhodes
`
`recognized that while a stent graft may be secured in place within a blood vessel by
`
`passive fixation from the stents or active fixation from anchors at the time of
`
`deployment, the stent graft could still experience caudal (i.e., downstream)
`
`migration after it had been deployed due to the shear forces from the blood flow
`
`exerted on the graft and the pulsatile expansion and contraction of the vessel.
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`(’417 Patent 3:36-38; Silver Decl. ¶ 45.) Specifically, in the “Background of The
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`Invention” section of the specification, Dr. Rhodes described this problem in the
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`Response
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`Page 9 of 56
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`stent graft field, noting that “[n]otwithstanding the foregoing, a need exists for
`
`means for ensuring good retention from migration for intraluminal grafts.” (’417
`
`Patent 3:35-37.) Dr. Rhodes further explained how the invention described in the
`
`’417 Patent would utilize the blood flowing through the graft to exert longitudinal
`
`and radial forces onto his designed anchors for providing a tight engagement with
`
`the wall so that unwanted migration could be prevented:
`
`As will be appreciated by those skilled in the art, with
`blood (or some other fluid) flowing through the device 20
`in the direction of arrow 46 a force will be applied by
`that flow to the interior surface of the sleeve 24, and from
`there through the stents to the projections 40. The force
`applied to the projections 40 will have a force component
`directed in the direction of the fluid flow, and a force
`component perpendicularly
`thereto,
`i.e., extending
`radially outward. Thus, the flow of fluid, e.g., blood,
`through the device 20 will tend to force the projections
`40 into good engagement with the wall 12 of the vessel,
`duct, or lumen. In the embodiment shown herein the
`projections penetrate or burrow slightly into the artery
`wall, as shown clearly in FIG. 4. Such penetration may
`not be necessary for good resistance to migration of the
`device. If some penetration is deemed desirable the
`height of the projections is selected so that their
`penetrating points do not penetrate too deeply into the
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`Response
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`Page 10 of 56
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`artery wall. In this regard, the height of the projections is
`selected so that they do not penetrate into the adventicial
`or medial layers of the artery wall, but can penetrate its
`intima. It is anticipated that for applications within the
`very largest arteries, such as the abdominal aorta, that the
`height of the projections will be in the range of
`approximately 1.0 mm to 1.5 mm. For intermediate
`arteries, the height of the projections will be in the range
`of approximately 0.75 mm to 1.0 mm, and for small
`arteries, the height of the projections will be in the range
`of approximately 0.5 mm to 1.0 mm.
`
`As should be appreciated by those skilled in the art the
`number of projections used in any device will also be a
`considerable factor in the amount of securement against
`migration provided
`thereby.
` Thus, as a general
`proposition, the more projections utilized
`the
`less
`“penetration” or “burrowing” will necessary for good
`securement against migration.
`
`(Id. 8:11-45.)
`
`This development was a critical advancement, especially when compared to
`
`the contemporary alternatives available at the time. (Silver Decl. ¶ 46.) A crucial
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`difference between Dr. Rhodes’ invention and the prior art is the use of the body’s
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`natural fluid forces to cause the anchoring that would prevent migration,
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`Response
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`specifically in relation to the direction of the blood flowing through the vessel.
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`(Id.)
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`In developing his novel design, Dr. Rhodes recognized that it would not be
`
`possible to control the depth of penetration of the anchors with perfect specificity
`
`due to a number of variables.* However, by focusing on the location, direction,
`
`orientation (angle), and height of the anchors, Dr. Rhodes designed anchors that
`
`would achieve the desired amount of engagement and penetration for securement
`
`of the device against migration but that would only penetrate the vessel wall to the
`
`degree necessary to counter the caudal downstream migration forces being exerted
`
`on the device after deployment. (’417 Patent 8:12-45; Silver Decl. ¶ 46.) For
`
`instance, if the device only experiences minimal migration forces, the anchors may
`
`only contact or slightly penetrate the vessel wall. (Silver Decl. ¶ 46.) However, if
`
`
`* Such variables include variances in the amount of force applied to the barbs from
`
`the blood flow, the thickness of the vessel wall between different patients and in
`
`different locations within the vessel, and the thickness and hardness of plaque
`
`that has built up at different locations on the interior of the vessel wall, as well as
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`the curvature of the vessel and the pulsatile expansion and contraction of the
`
`vessel. (Silver Decl. ¶ 46.)
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`Response
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`Page 12 of 56
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`the device experiences more significant migration forces, the anchors may burrow
`
`more deeply into the vessel wall to counter the larger forces. (Id. ¶ 46.) Yet, in
`
`either case, the anchors are designed such that they do “not pose a significant risk
`
`of perforating the tissue of the vessel, duct, or lumen.” (’417 Patent 3:53-57.)
`
`As will be discussed in further detail below, the prior art references cited in
`
`the Petition focus on anchors that fully engage the vessel wall to provide the
`
`necessary attachment to fix the device in place immediately upon completion of
`
`the device’s deployment, as would be the case with sutures. These anchors
`
`undergo full attachment during deployment and would not experience any further
`
`gain in fixation or migration resistance as a result of the blood flow forces. Rather,
`
`the blood flow forces would either have no effect on the amount of securement
`
`provided by the anchors or force the anchors to further penetrate the vessel such
`
`that there would be an increased risk of damage to the vessel wall, or an exertion of
`
`force on the anchor that could result in damage to the anchor itself. (See Ex. 2012
`
`(“the Malina Article”); Rowe Dep. Tr. (Ex. 2023) at 76:5-81:25; Gupta Dep. Tr.
`
`(Ex. 2021) at 52:9-14, 132:16-25.)
`
`For example, if the anchor is forced to penetrate more deeply into the vessel
`
`wall, it risks damage to the integrity of the structure of the vessel wall, which could
`
`lead to dissection, as well as hemorrhaging or damage to surrounding organs.
`
`(Silver Decl. ¶ 44, 47.) If the anchor has reached, or is near, its full level of
`
`Response
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`Case No. IPR2014-00100
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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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`(Id.) If the vessel wall does not tear under the additional downstream shear forces
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`from the blood flow, a torque would be exerted on the anchor that could cause the
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`anchor to invert or fracture. (Id.) In any of these cases, the anchor would no
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`longer be effective for its purpose of securing the device in place.
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`Dr. Rhodes specifically hoped to improve on these problems with his ’417
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`Patent by focusing on the effect anchoring mechanisms had on the vessel wall after
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`deployment. (’417 Patent 7:16-32, 8:12-38; Silver Decl. ¶ 49.) Dr. Rhodes
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`demonstrated the importance of this concept throughout the claims and the
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`prosecution history of the ’417 Patent. For example, in claim 1, the ’417 Patent
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`requires “…whereupon the force applied to said tubular member by the fluid
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`flowing through said passageway produces on each of said projections a force
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`component to cause said at least one surface to tightly engage the interior surface
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`of the vessel, duct, or lumen to fixedly secure said device in place.” (’417 Patent
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`9:40-46 (emphases added).) Dr. Rhodes contemplated that his novel anchoring
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`projections, by using the natural forces provided by the blood flowing through the
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`graft, would allow the graft to secure itself post-deployment and further help
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`prevent migration, if needed. (’417 Patent 7:16-32, 8:12-38; Silver Decl. ¶ 49.)
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`Response
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`The prosecution history further demonstrates Dr. Rhodes’ intent. In an
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`amendment in May of 1996, Dr. Rhodes indicated that each and every projection
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`of his design must be oriented in an acute angle in the downstream direction, as
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`well as appropriately shaped and sized in order to achieve the desired result, i.e., to
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`have at least one surface of the trailing portion of the projection be caused to
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`tightly engage the interior surface of the vessel to fixedly secure the device in place
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`as a result of the forces applied from fluid flowing through the device:
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`(Ex. 1002 at 46).
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`In this same amendment, Dr. Rhodes explained how this development
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`distinguished itself over the prior art, demonstrating the need for the fluid force to
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`help secure the graft in place versus previous stent graft attachment methods:
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`Response
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`(Ex. 1002 at 48-49).
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`The concept of using the natural forces of blood flowing through the stent
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`graft to prevent migration after deployment would specifically be a targeted benefit
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`Response
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`by medical device manufacturers in the industry, however, without giving credit to
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`Dr. Rhodes. (Silver Decl. ¶ 52.)
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`D. The Industry’s Use of Dr. Rhodes’s Ideas and the Implicit
`Acknowledgement of the Importance of its Benefits
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`In 1997, two years after Dr. Rhodes filed his ’417 Patent, the first report on
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`endovascular graft migration was published. (See Ex. 2025; see also Ex. 2026 at 2
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`(2005 article citing to Ex. 2021 as “[t]he first report on device migration”).) A
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`year later, in 1998, the Malina Article (Ex. 2011) was published in the Journal for
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`Endovascular Surgery regarding the benefits of using anchors to prevent migration.
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`The Malina Article discussed the importance of using hooks and barbs to properly
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`anchor the graft into the wall to prevent migration after deployment. Specifically,
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`the article mentioned:
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`Thus, attempts to improve endovascular graft anchoring
`by excessive oversizing of smooth stents might be futile,
`especially because stents may cause pressure ulcers and
`perforations of the vessel walls. Rather than being
`pushed into the aortic wall by the radial force of the
`stent, the hooks and barbs engage the aortic wall
`when the stent-graft
`is pulled distally by the
`bloodstream. The angle between the stent and its
`hooks and barbs is important for this action.
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`(Id. at 6 (emphasis added).) This realization, three years after Dr. Rhodes’ first
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`developed it, mirrors what is stated in the ’417 Patent:
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`. . . said trailing portion including at least one surface
`preferentially oriented to extend at an acute angle to the
`first direction, whereupon the force applied to said
`tubular member by the fluid flowing through said
`passageway produces on each of said projections a force
`component to cause said at least one surface to tightly
`engage the interior surface of the vessel, duct, or lumen
`to fixedly secure said device in place.
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`(’417 Patent 9:38-45.)
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`While others desired the benefits of Dr. Rhodes’ innovative design relative
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`to the angle of barb penetration, they did not arrive at that conclusion until much
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`later than Dr. Rhodes. (Silver Decl. ¶¶ 94-103.) For instance, other patents
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`disclose the dangers and problems associated with preventing stent graft migration
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`that Dr. Rhodes had identified years before:
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`Migration can be a significant problem in the placement
`of expandable stents and other intraluminal devices,
`particularly when placed in the vascular system where
`the prosthesis is subject to the forces of blood, especially
`on the arterial side. Nowhere is the prevention of
`migration more important and more challenging than
`when placing a stent graft to repair an abdominal aortic
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`Response
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`aneurysm (AAA) where downstream migration of the
`device can result in the aneurysm no longer being
`excluded. If the aneurysm is no longer intact or
`subsequent rupture were to occur, the patient would then
`face an increased risk of death. Unlike surgically placed
`grafts which are sutured into place, only the radial forces
`of the stent would be available to hold the prosthesis into
`place.
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`the problem of migration, stent graft
`To address
`manufacturers sometimes place a series of barbs or hooks
`that extend outward from
`the main body of
`the
`prosthesis, typically at its proximal end, either by
`attaching them to the stent frame with solder or by some
`other bonding technique, or to the graft material,
`typically by suturing. It has been observed that sutures
`attaching barbed stents to the graft material are subject to
`breakage due in part to the flexibility of the graft material
`and the considerable pulsatile forces of arterial blood
`acting on the device. These forces have been known to
`directly contribute to the detachment between the graft
`portion and anchoring stent.
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`It has also been observed that barbs soldered or otherwise
`attached to the stent frame are subject to fracture,
`detachment, or other failure, especially when the forces
`become concentrated at a particular location along the
`stent graft. Unfortunately, simply making the barbs
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`Response
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`stronger to prevent fracture can result in increased
`damage to the anchoring tissue. Furthermore, adding
`rigidity
`to
`any
`outward-projecting
`barbs may
`compromise the ability of the device to be compressed