Declaration previously submitted in conjunction with
`Medtronic, Inc. and Medtronic Vascular, Inc.’s Petition
`for Inter Partes Review in IPR2020-00136, et seq.
`
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`IPR2020-00126/-127/-128/-129/-130/-132/-134/-135/-136/-137/-138
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`Medtronic Ex. 1905
`Medtronic v. Teleflex
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioners,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`
`Case No.: IPR2020-00136
`U.S. Patent No: RE45,776
`
`
`
`DECLARATION OF RICHARD A. HILLSTEAD, PH.D., FAHA
`
`
`
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`IPR2020-00136
`Patent RE45,776
`
`TABLE OF CONTENTS
`
`
`Overview of Common Knowledge Related to Flexibility and
`
`INTRODUCTION ............................................................................................. 1
`I.
`QUALIFICATIONS .......................................................................................... 1
`II.
`SCOPE OF WORK ........................................................................................... 4
`III.
`IV. OVERVIEW OF ART ....................................................................................... 6
`A. Overview of Kontos ................................................................................ 6
`B.
`Overview of Ressemann and Common Teachings in the Art ................. 9
`C.
`Background on catheter sizes ................................................................13
`D. Overview of Takahashi .........................................................................14
`E.
`Reinforcement .......................................................................................16
`F.
`Overview of Kataishi ............................................................................23
`KONTOS AND RESSEMANN COMBINATION .........................................26
`A. A POSITA would have been motivated to modify Kontos to add
`as taught by Ressemann ........................................................................26
`B.
`proximal opening more rigid than the tubular structure. ......................41
`C.
`structure. ................................................................................................44
`D. Kontos as modified by Ressemann discloses reinforcing the
`polymer. .................................................................................................45
`E.
`or coil that is 20 to 30 cm. .....................................................................50
`F.
`support collar that form a rigid portion of the extension catheter.........51
`G. Kontos as modified by Ressemann discloses a partially
`cylindrical opening and a tubular structure that is reinforced. .............53
`
`V.
`
`a partially cylindrical opening proximal of the tubular structure,
`
`Kontos as modified by Ressemann’s support collar discloses a
`
`Kontos as modified by Ressemann’s support collar includes a
`concave track that is continuous with the lumen of the tubular
`
`tubular structure with a braid or a coil that is surrounded by a
`
`Kontos as modified by Ressemann discloses a reinforcing braid
`
`Kontos as modified by Ressemann discloses a wire 14 and
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`IPR2020-00136
`Patent RE45,776
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`cylindrical opening that has a greater flexural modulus than tube
`
`Kontos as modified by Ressemann discloses at least two inclined
`
`Kontos in combination with Ressemann, in further view of
`Takahashi discloses a tubular structure that is uniform in size
`
`VIEW OF KATAISHI AND/OR THE COMMON KNOWLEDGE OF
`
`view of Kataishi to arrive at proximal opening with two inclines
`
`A POSITA would be motivated to modify Kontos in combination
`with Ressemann in view of Takahashi, in further view of
`
`COMBINATION WITH GUIDE CATHETER 38 ASSISTS IN
`RESISTING AXIAL AND SHEAR FORCES EXERTED BY AN
`INTERVENTIONAL CARDIOLOGY DEVICE THAT TEND TO
`
`H. Kontos, as modified by Ressemann, discloses a partially
`16 of tubular structure. ..........................................................................54
`I.
`regions ...................................................................................................54
`VI. KONTOS IN COMBINATION WITH RESSEMANN IN FURTHER
`VIEW OF TAKAHASHI .................................................................................57
`A. A POSITA would be motivated to combine Takahashi with
`Kontos and Ressemann .........................................................................57
`B.
`from a proximal end to a distal end ......................................................60
`VII. KONTOS IN COMBINATION WITH RESSEMANN IN FURTHER
`A POSITA ........................................................................................................61
`A. A POSITA would be motivated to modify Kontos/Ressemann in
`and non-inclined region ........................................................................61
`B.
`Kataishi and/or the common knowledge of a POSITA .........................65
`VIII. KONTOS DISCLOSES THAT THE SUPPORT ASSEMBLY 10 IN
`DISLODGE A GUIDE CATHETER FROM A BRANCH ARTERY ............66
`
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`IPR2020-00136
`Patent RE45,776
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`TABLE OF EXHIBITS
`
`Description
`U.S. Patent No. RE45,776 (“the ’776 patent”)
`
`U.S. Patent No. 7,736,355 (“Itou”)
`
`U.S. Patent No. 7,604,612 (“Ressemann”)
`
`U.S. Patent No. 5,439,445 (“Kontos”)
`
`New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`
`Excerpt from Grossman’s Cardiac Catheterization, Angiography, and
`Intervention (6th edition) (2000) (chapters 1, 4, 11, 23-25).
`
`U.S. Patent No. 5,891,056 (“Ramzipoor”)
`
`Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March
`4, 2004)
`
`U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`
`The sliding rail system (monorail): description of a new technique
`for intravascular instrumentation and its application to coronary
`angioplasty, Z. Kardio. 76:Supp. 6, 119-122 (1987) (“Bonzel”)
`
`U.S. Publication Application No. 2004/0236215 (Mihara)
`
`U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`
`U.S. Patent No. 6,042,578 (“Dinh”)
`
`No.
`1401
`
`1407
`
`1408
`
`1409
`
`1410
`
`1415
`
`1418
`
`1424
`
`1425
`
`1432
`
`1433
`
`1435
`
`1446
`
`1447 WO 97/37713 (“Truckai”)
`
`1448
`
`Terumo Heartrail II product literature
`
`iii
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`
`
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`IPR2020-00136
`Patent RE45,776
`
`Description
`No.
`1449 Medtronic Launcher product literature
`
`1450
`
`1451
`
`1455
`
`1461
`
`1462
`
`1475
`
`U.S. Patent No. 5,980,486 (“Enger”)
`
`U.S. Patent No. 5,911,715 (“Berg”)
`
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`
`U.S. Patent No. 5,690,613 (“Verbeek”)
`
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`
`Excerpt from Plaintiff’s infringement allegations in Vascular
`Solutions, LLC. v. Medtronic, Inc., D. Minn., No. 19-cv-01760
`(October 11, 2019), D.I. 1-14.
`
`1479
`
`Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`
`
`
`
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`IPR2020-00136
`Patent RE45,776
`Introduction
`I.
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`1.
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinion on the disclosures of certain patents.
`
`2.
`
`I am informed that Medtronic intends to use my opinion in support of
`
`its petition to the Patent Trial and Appeal Board (“PTAB”) for Inter Partes Review
`
`(“IPR”) of U.S. Patent No.: RE45,776.
`
`3.
`
`I make this declaration based on my personal education, experience,
`
`and knowledge in the field of medical device product development.
`
`II. Qualifications
`4. My curriculum vitae is being submitted as Ex. 1443.
`
`5.
`
`I have been actively involved in the design and development of
`
`medical devices for more than thirty years. I held several progressive, Product
`
`Research and Development positions with Cordis Corporation (J&J) from 1987 to
`
`1993 where I was responsible for the design and development of numerous
`
`vascular intervention devices including stents and angioplasty balloon catheters. I
`
`pioneered device development in the Cordis Coronary Stent program as a Senior
`
`Corporate Research Engineer. During my tenure at Cordis, I also held the position
`
`of Senior Engineer, Custom Products, where I was responsible for designing a
`
`wide variety of customized catheters and devices for individual physicians.
`
`
`
`
`1
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`From 1993 until 1999, I directed new technology development for
`6.
`
`Georgia-based Novoste Corporation, primarily focusing on intravascular
`
`brachytherapy and catheter based delivery systems for the treatment of coronary
`
`restenosis following angioplasty and stenting.
`
`7.
`
`In 1999, I became a founding member of The Innovation Factory, a
`
`private medical device incubator in Duluth, GA. At The Innovation Factory, I
`
`served as Chief Science Officer and was primarily responsible for early clinical
`
`investigations, and overall R&D in a wide variety of life science ventures.
`
`8.
`
`I was a principal partner and founding member in Accuitive Medical
`
`Ventures I and II (2004 – 2008). Accuitive Medical Ventures is a $225M venture
`
`capital fund focused entirely on growing early stage medical device companies into
`
`attractive candidates for acquisition. In 2008, I joined another medical device
`
`venture fund, Georgia Venture Partners (GVP), where I remain a partner today.
`
`9.
`
`I have managed numerous, diverse, multi-disciplinary development
`
`teams from product concept through clinical approval to sales release. I am a
`
`frequent speaker on the importance of innovation and intellectual property creation
`
`and capture as it relates to the entrepreneurial process in the medical device
`
`industry at conferences and scientific sessions.
`
`10. Currently, I am CEO of Richard A. Hillstead Inc., a medical device
`
`development and entrepreneurship consulting firm located near Atlanta, GA. I am
`2
`
`
`
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`IPR2020-00136
`Patent RE45,776
`also the current Chairman and former CEO of Biofisica Inc., a Georgia wound
`
`healing device company. I am a past Chairman and co-founder of Cerebral
`
`Vascular Applications, Inc. (CVA), a Georgia company dedicated to reducing the
`
`incidence of stroke through closure of the atrial appendage of the heart. I am a
`
`former member of the Emory University New Technology Advisory Board, where
`
`I participated in reviewing promising new medical device technologies and
`
`recommended development strategies.
`
`11.
`
`I was the 2019 recipient of the Georgia BIO Golden Helix Award for
`
`Industry Growth, the highest award bestowed in the state of Georgia for medical
`
`device design, development, and entrepreneurship.
`
`12.
`
` I am named inventor on approximately eighty issued U.S. patents and
`
`pending applications as well as dozens of international patents. My patents pertain
`
`to medical device design, and a majority of these patents relate specifically to
`
`catheter design. My patents and patent publications have been cited, globally, over
`
`8000 times.
`
`13.
`
`In 2012 and 2013, I served as an Entrepreneur in Residence to the
`
`United States Food and Drug Administration.
`
`14.
`
`I am a Fellow in the American Heart Association (FAHA) on the
`
`Council of Clinical Cardiology, Fellow on the Council on Lifestyle and
`
`
`
`
`3
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`IPR2020-00136
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`Cardiometabolic Health, and am a current member of the Stroke Council and
`
`Council on Cardiopulmonary Resuscitation.
`
`15.
`
`I have no financial interest in Medtronic. I similarly have no financial
`
`interest in the asserted patents, and have had no contact with the named inventors
`
`of the asserted patent.
`
`III. Scope of Work
`I have been asked to review the ’776 patent and opine on the level of
`16.
`
`ordinary skill in the art as of May 3, 2006.
`
`17.
`
`I have additionally been asked to consider and provide my opinions
`
`on disclosures in the following references:
`
`1)
`
`2)
`
`U.S. Pat. No. 5,439,445 to Kontos (“Kontos”) (Ex. 1409);
`
`U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”) (Ex.
`
`1408)
`
`3)
`
`“New Method to Increase a Backup Support of a 6 French
`
`Guiding Coronary Catheter,” Catheterization and
`
`Cardiovascular Interventions, 63:452-456 to Takahashi
`
`(“Takahashi”) (Ex. 1410); and
`
`4)
`
`U.S. Pat. Pub. No. 2005/0015073 to Kataishi et al., (“Kataishi”)
`
`(Ex. 1425)
`
`
`
`4
`
`
`
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`IPR2020-00136
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`V.
`The Person of Ordinary Skill in the Art
`
`18.
`
`I am not a lawyer and have been informed by counsel of the legal
`
`standards set forth herein. I have also been informed by counsel of factors that may
`
`be considered in determining the level of ordinary skill in the art include (a) the
`
`educational level of the inventor; (b) the type of problem encountered in the art; (c)
`
`prior art solutions to those problems; (d) the rapidity with which inventions are
`
`made; (e) sophistication of the technology; and (f) the educational level of those
`
`working in the field.
`
`19.
`
`I have reviewed the ’776 patent. For the ’776 patent, a person of
`
`ordinary skill in the art (“POSITA”) at the time of the alleged invention (May 3,
`
`2006) would have had (a) a medical degree; (b) completed a coronary intervention
`
`training program, and (c) experience working as an interventional cardiologist.
`
`Alternatively, a POSITA would have had (a) an undergraduate degree in
`
`engineering, such as mechanical or biomedical engineering; and (b) three years of
`
`experience designing medical devices, including catheters or catheter-deployable
`
`devices. Extensive experience and technical training might substitute for education,
`
`and advanced degrees might substitute for experience. Additionally, a POSITA
`
`with a medical degree may have access to a POSITA with an engineering degree,
`
`and one with an engineering degree might have access to one with a medical
`
`degree.
`
`
`
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`IPR2020-00136
`Patent RE45,776
`IV. Overview of Art
`A. Overview of Kontos
`20. U.S. Patent No. 5,439,445 (“Kontos”) is titled “Support Catheter
`
`Assembly.” See Ex. 1409. It was filed on June 27, 1994 and issued August 8, 1995.
`
`21. Kontos discloses “[a] support catheter assembly” for “facilitating
`
`insertion of a PTCA balloon into a lesion.” Ex. 1409, 1:10-13. PTCA stands for
`
`percutaneous transluminal coronary angioplasty. Kontos states that “the support
`
`catheter can be inserted into and passed through a guide catheter, over a PTCA
`
`catheter, and out the distal end of the guide catheter so as to function as an
`
`extension of the guide catheter to bridge the gap (or at least some of it) between the
`
`end of the guide catheter and the stenosis to be opened.” Id. at 2:16-22.
`
`22. Kontos details that when removing a stenosis, “[t]he guide catheter
`
`[…] can generally reach only to the coronary ostia, whereas the lesion to be opened
`
`is most commonly located in one of the coronary arteries leading from the ostia.”
`
`Ex. 1409, 1:39-42. Because a guide catheter cannot extend beyond the ostia of a
`
`coronary artery, a therapeutic device such as a balloon catheter must traverse the
`
`coronary artery without the beneficial support of a guide catheter. See Ex. 1409,
`
`1:42-45. Since “the distal end of a PTCA catheter is made to be extremely soft and
`
`flexible,” it is “readily susceptible to kinking and bending” if unsupported by a
`
`guide catheter when traversing a coronary artery. See Ex. 1409, 1:30-38. Kontos
`
`
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`solves this problem and “facilitate[s] the passage of the balloon catheter from the
`
`end of the guide catheter to the lesion” by supporting the therapeutic device with a
`
`“support catheter assembly 10” that functions as an extension of the guide catheter.
`
`Ex. 1409, 1:46-49; see also id. 2:16-22.
`
`23. Fig. 6B from Kontos, reproduced below, illustrates the support
`
`assembly catheter 10 functioning as an extension of the guide catheter 38. A PTCA
`
`balloon catheter 40 is shown disposed within the support catheter and readied for
`
`deployment into a lesion. See Ex. 1409 at 1:9-13.
`
`Ex. 1409, Fig. 6B
`
`24. Figure 6C (below) illustrates the balloon catheter 40 extended beyond
`
`the distal end of the support catheter assembly 10 and into the lesion (stenosis).
`
`
`
`Ex. 1409, Fig. 6C.
`
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`25. As illustrated in Fig. 6C, above, “when extending beyond the distal
`
`end of guide catheter 38, body 12 functions as a guide catheter extension, and the
`
`gap that PTCA catheter 40 must negotiate without assistance is made much
`
`shorter.” Ex. 1409, 5:49-52.
`
`26. Kontos describes a support assembly 10 that includes wire 14 and
`
`body 12. “Body 12 [] can be viewed as a mini guide catheter…” Ex. 1409, 3:47.
`
`Body 12 includes a tube 16 and soft tip 28. See Ex. 1409, Fig. 1; 3:45-55.
`
`Ex. 1409, Fig. 1, color added.
`
`27.
`
`Insertion wire 14 is permanently affixed to the distal tube 16. Kontos
`
`
`
`states:
`
`Insertion wire 14 is attached to base portion 18 at proximal end 20 of
`tube 16, and preferably is permanently affixed thereto. For example, as
`best shown in FIGS. 1, 3 and 4, wire 14 may be connected to base
`portion 18 by inserting it into a receiving hole 34, and affixing it therein
`by, for example, gluing, pressure fitting, shrink fitting, or the like.
`Alternatively, tube 16 may be molded directly onto application wire 14.
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`Numerous other methods of connecting wire 14 to body 12 will readily
`occur to those skilled in the art.
`
`Ex. 1409, 4:25-34.
`
`28. Kontos teaches that “[t]ube 16 may be composed of any pliable
`
`material suitable for percutaneous medical procedures, but preferably is composed
`
`of a molded plastic material, such as polyethylene.” Ex. 1409, 4:1-4. “[S]oft tip 28
`
`generally is cylindrical in shape and extends coaxially from distal end 24 of tube
`
`16.” Id. at 4:5-7. “Soft tip 28 may be composed of any highly flexible material
`
`suitable for percutaneous medical procedures, but preferably is composed of a soft
`
`plastic such as a copolymer of polyethylene and ethyl vinylalcohol (EVA).” Id. at
`
`4:7-12. 1
`
`B. Overview of Ressemann and Common Teachings in the Art
`29. U.S. Pat. No. 7,604,612 to Ressemann (“Ressemann”) was filed
`
`August 9, 2002 and issued October 20, 2009.
`
`30. Ressemann teaches “a partial length evacuation sheath” used to
`
`“evacuat[e] emboli, particulate matter, and other debris from a blood vessel.” (Ex.
`
`
`1 POSITA would appreciate that in this case patentee has acted as his own
`
`lexicographer as the common shorthand for ethylene vinyl alcohol is EVOH, while
`
`EVA typically refers to ethylene vinyl acetate.
`
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`1408, 3:59-60; 5:65-67.) The evacuation sheath of Ressemann is intended to be
`
`deployed with the aid of a guide catheter that is positioned within the ostium of a
`
`coronary artery, while the evacuation sheath may be advanced through the guide
`
`catheter and beyond a major side branch of a target vessel. (Ex. 1408. 12:26-30.)
`
`31. Ressemann’s evacuation sheath assembly is for aspirating embolic
`
`material, id., Abstract; 12:9-13:34, and for stent or balloon delivery. Id., 6:25-34;
`
`12:3-8.
`
`32. The evacuation sheath includes a distal evacuation head 132 and shaft
`
`portions (including proximal shaft 110, distal shaft 120). Id., 6:19-20, 10:36,
`
`10:60-62, Figs. 1A, 1C, 11A. The head is “preferably made of a relatively flexible
`
`polymer such as low-density polyethylene, polyurethane, or low durometer
`
`Pebax® material.” Id., 6:36-39. (The head 132 is illustrated below in pink).
`
`33. Ressemann teaches that a coil 139 can be embedded into the tube to
`
`provide kink resistance. Id. 7:1-7. “A covering of polyurethane can then be applied
`
`to contain the coil 139,” and secure it in position within evacuation lumen 140.”
`
`Id., 7:8-12; Fig. 1C. Ressemann describes that the distal end of the tube is “angled”
`
`to impart more flexibility at the distal tube’s end. See id., 7:48-51.
`
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`34. Ressemann also teaches deploying a stent through evacuation head
`
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`132, as shown below in Figure 6E, excerpted below.
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`Ex. 1408, Figure 6E, color and annotations added.
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`35. Ressemann also teaches to angle the proximal opening of its
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`evacuation head. Ressemann teaches that the angle at 140a allows for smoother
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`passage of therapeutic devices through the lumen 140 and the larger area of an
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`angled opening (as opposed to the area of an opening formed by a vertical end to
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`lumen 140) allows for larger material to pass through the lumen more smoothly.
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`The proximal and distal ends 140 a, 140 b of
`the evacuation
`lumen 140 are preferably angled to allow for smoother passage of the
`evacuation sheath assembly 100 through a guide catheter, and into a
`blood vessel, and to facilitate smoother passage of other therapeutic
`devices through the evacuation lumen 140 of the evacuation head 132.
`The larger area of the angled open ends also allows for larger
`deformable particulate matter to pass through the lumen more
`smoothly.
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`Ex. 1408, 6:52-60 (100 embodiment); see also id., 24:33-38 (2100 embodiment).
`36. The flexibility of Ressemann’s evacuation sheath assembly is
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`engineered in multiple ways. The bending stiffness of stiffness transition member
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`135 “decreases gradually from the proximal end to the distal end of the stiffness
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`transition member 135.” (Ex. 1408, 11:57-59.) Ressemann also discloses
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`transitioning the stiffness of the tube 138 by incorporating a kink-resistant coil 139
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`that includes its proximal and distal ends wound at a reduced pitch to allow the
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`final coil to be positioned at the marker bands 146a and 146b and avoid kinking at
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`that interface. (Ex. 1408, 7:19-28.)
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`37. Either the decreasing rigidity of member 135 (alone), or the absence
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`of kink-resistant coil 139 at the distal end of the evacuation head made of a flexible
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`polymer (alone), renders the distal end of the evacuation head more flexible than
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`its more proximal regions.
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`C. Background on catheter sizes
`38. Clearly, Ressemann’s evacuation head is sized such that a balloon
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`deliverable stent can be passed through its lumen. See Ex. 1408, Fig. 6E, 6F. To
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`understand a bit more about the sizing of catheters and devices, I provide a brief
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`background on the size of catheters and interventional devices. The French gauge
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`size is a quantitative measure common in catheter design that was developed in the
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`19th century. (Ex. 1462 at 545.) The “French size” (commonly abbreviated as
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`“Fr”) is a standard unit of measure of the diameter of a catheter. One French equals
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`1/3 mm. (Ex. 1462 at 545.)
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`39. A guide catheter must be small enough to fit in the artery of the
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`patient yet big enough to accommodate interventional devices such as balloon
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`catheters, and stents. As of May 3, 2006, guide catheters generally ranged in size
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`from 5 French to 8 French. (See Ex. 1410 at 453-454 & Ex. 1415 at 548-549.)
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`D. Overview of Takahashi
`40. The article “New Method to Increase a Backup Support of a 6 French
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`Guiding Coronary Catheter” by Takahashi et. al. (“Takahashi”), published in
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`Catheterization and Cardiovascular Interventions in 2004 and describes a 5Fr in
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`6Fr mother-and-child system that provides greater backup support than a 7Fr guide
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`catheter.2 (Ex. 1410.)
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`41. As described by Takahashi, the 5 Fr Heartrail catheter had an inner
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`diameter of 0.059 inches (1.50 mm) (see Ex. 1448) and could accept “normal
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`balloons or stent delivery systems less than 4.0 mm in diameter.” (Ex. 1410 at
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`452.) (The 4.0 mm diameter notation of the balloon or stent refers to its fully
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`expanded size and not its size prior to inflation or expansion.) (See also Ex. 1424,
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`which describes the Taxus rapid exchange delivered stent for use with a 5 Fr guide
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`catheter (guide catheter inner diameter equal to or greater than 0.058 inches).)
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`42. Takahashi teaches inserting a 5 Fr guiding catheter with an inner
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`lumen size of 0.059 inches into a 6 Fr guiding catheter with an inner lumen size of
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`0.071 inches (at “B”). Ex. 1410 at 452, 454. The difference between the inner
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`2 Vol. 63, pages 452-456.
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`lumen diameters of the two guiding catheters is 0.012 inches (0.30 mm), which is
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`not more than one French size3 in difference. Id.
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`43. Once the 6 Fr guiding catheter is placed at the ostia of the coronary
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`artery (“E”), Takahashi teaches to extend the 5 Fr guiding catheter beyond the
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`distal end of the 6 Fr guiding catheter and into the coronary artery. Ex. 1410 at 454.
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`Then, Takahashi places the balloon at the lesion with the advantage of the
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`additional backup support provided by the extension of the 5 Fr guiding catheter.
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`Id.
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`3 One French equals 1/3 of a millimeter or 0.33 mm.
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`E. Overview of Common Knowledge Related to Flexibility and
`Reinforcement
`It is important to understand the criteria that must be met by any
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`44.
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`device that is required to be inserted into the vasculature and traverse the anatomy
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`from the groin to the heart (or from the wrist to the heart, in the case of radial
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`artery access). When referring to relative rigidities of devices that pertain to PTCA,
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`a POSITA would understand rigidity to refer to the extent to which a device or
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`component can be flexed or bent in a lateral direction.
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`1.
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`First, the device must be flexible enough to traverse the curves
`and bends of the patient’s vasculature.
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`2.
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`Second, the device must not damage the vasculature.
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`3.
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`Third, the device must be rigid enough or “pushable” so that it
`does not significantly compress or stretch during placement and
`is “steerable” enough to navigate tortuous vasculature.
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`45. By May 3, 2006, it was well known that a balance between flexibility,
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`rigidity, and atraumatic properties must be maintained when designing a PTCA
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`catheter. Numerous teachings of this balance of features existed in the art at this
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`time. (Ex. 1415 at 549; and Ex. 1451, 2:35-46; see also, Ex. 1407; Ex. 1408; and
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`Ex. 1409.)
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`46. For example, it was known in the art that the distal tip of a catheter
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`should be soft. Guide catheters, for example, included “a very soft material in the
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`most distal 2 mm of the catheter to reduce the chance of vessel trauma.” Ex. 1415
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`at 549. Similarly, the distal end of PTCA catheters were “made to be extremely soft
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`and flexible so as to facilitate its passage through tortuosities and restrictions in the
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`vascular system.” Ex. 1409, 1:30-33. In addition, support catheters designed to
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`extend beyond the distal tip of a guide catheter were also designed to “have a soft
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`tip.” Ex. 1409, 2:53, 4:5. For example, as Kontos describes, a soft tip could be
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`made of a soft plastic, such as “a copolymer of polyethylene and ethyl-vinylalcohol
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`(EVA).” Id., 4:10-11.
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`47. More generally, it was known in the art that in order for coronary
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`catheters to traverse safely the vasculature, the preferred material used to form the
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`catheter should either be a polymer or a material coated with a polymer. See e.g.,
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`Ex. 1407, 3:30-37; 3:50-58; Ex. 1408, 6:37-42; 6:66-7:14. Most commonly around
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`2000, guide catheters were formed of either polyethylene (Cook Inc.,
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`Bloomington, IN) or polyurethane (Cordis Corporation, Miami, Fl., and USCI,
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`Billerica, MA) and contain either steel braid, nylon, or other reinforcing materials
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`within the catheter wall. (Ex. 1415 at 214.) Occasionally reference to “resin” in the
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`literature in conjunction with catheter materials and their manufacture, means that
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`the final catheter material is formed of a polymer. Resins are the raw materials that
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`are used to form the final polymer. 4 Colloquially in the catheter arts, reference to a
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`“resin” can mean that the catheter is formed of a polymer. See e.g., Ex. 1407, 3:30-
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`37; 3:50-58.
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`48. The way in which scientists and engineers quantitatively measure the
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`relative rigidity and flexibility of catheter is by determining their flexural modulus.
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`Flexural modulus is a material property that expresses “[a] measure of resistance . .
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`4 See https://www.ptonline.com/knowledgecenter/profile-extrusion/glossary-of-
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`terms. Last accessed Oct. 11, 2019. While this reference is from present day, the
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`meaning of resin has not changed since May 3, 2006.
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`. to bending.” (Ex. 1440, 772). In other words, flexural modulus measures the
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`tendency of a material to resist flexure (otherwise known as bending). A material
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`with a higher flexural modulus is less flexible than a material with a lower flexural
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`modulus.
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`49.
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`It was known in the art to desi