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.: IPR2020-01342
`U.S. Patent No: 8,142,413
`
`
`
`DECLARATION OF RICHARD A. HILLSTEAD, PH.D., FAHA
`
`
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`IPR2020-01342
`Patent 8,142,413
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`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ....................................................................................... 1
`I.
`II. QUALIFICATIONS .................................................................................... 1
`III. SCOPE OF WORK ..................................................................................... 4
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ............................. 4
`V. OVERVIEW OF ART ................................................................................. 5
`A. Overview of Kontos ............................................................................ 5
`B. Overview of Adams ............................................................................. 9
`C. Overview of Takahashi ....................................................................... 11
`D. Overview of Common Knowledge Related to Flexibility and
`Reinforcement ....................................................................................14
`VI. KONTOS DISCLOSURE ..........................................................................19
`A. Kontos discloses that the support assembly 10 in combination
`with guide catheter 38 provides backup support to an
`interventional cardiology device for use in the coronary
`vasculature..........................................................................................19
`B. Kontos in combination with Adams teaches increasing the inner
`diameter of Kontos’s tube 16 to deliver a greater variety of PCI
`catheters. ............................................................................................23
`C. Kontos expressly discloses to a POSITA that its wire 14 is more
`rigid along the longitudinal axis than the tube 16 and soft tip 28
`of body 12. .........................................................................................25
`D. Kontos in combination with Adams teach a POSITA to modify
`the flare opening of Kontos and angle the opening instead. ................27
`Kontos in combination with Adams teaches reinforcing Kontos
`tube 16 with reinforcement such as metallic coiling or braiding. ........37
`A POSITA would be motivated to combine Kontos, Adams, and
`Takahashi to arrive at a one French difference between the
`support assembly 10 and guide catheter. .............................................40
`G. Kontos in combination with the common knowledge in the art
`teaches a marker band embedded in tube 16. ......................................43
`VII. CONCLUDING REMARKS .....................................................................45
`
`E.
`
`F.
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`EXHIBIT LIST
`
`
`1415
`
`Exhibit Description
`1407 U.S. Patent No. 7,736,355 (“Itou”)
`1408 U.S. Patent No. 7,604,612 (“Ressemann”)
`1409 U.S. Patent No. 5,439,445 (“Kontos”)
`1410 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).
`1418 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1424 Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March 4,
`2004)
`1425 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1432
`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”)
`1433 U.S. Publication Application No. 2004/0236215 (Mihara)
`1435 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1443 Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1446 U.S. Patent No. 6,042,578 (“Dinh”)
`1447 WO 97/37713 (“Truckai”)
`1449 Medtronic Launcher product literature
`1450 U.S. Patent No. 5,980,486 (“Enger”)
`1451 U.S. Patent No. 5,911,715 (“Berg”)
`1454 U.S. Patent No. 5,120,323 (“Shockey”)
`1461 U.S. Patent No. 5,690,613 (“Verbeek”)
`1462
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`
`1497
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`IPR2020-01342
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`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. 8,142,413.
`
`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 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.
`
`
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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 the CEO of Richard A. Hillstead Inc., a medical
`
`device development and entrepreneurship consulting firm located near Atlanta,
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`GA. I am 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
`
`8,000 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
`
`
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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 ’413 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. U.S. Pat. No. 5,439,445 to Kontos (“Kontos”) (Ex-1409);
`
`2. U.S. Pub. No. 2004/0010280 to Adams (“Adams”) (Ex-1435); and
`
`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).
`
`IV. THE PERSON OF ORDINARY SKILL IN THE ART
`I am not a lawyer and have been informed by counsel of the legal
`18.
`
`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)
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`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 ’413 patent. For the ’413 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.
`
`V. 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.
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`21. Kontos discloses “[a] support catheter assembly” for “facilitating
`
`insertion of a PTCA balloon into a lesion.” Id., 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., 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.”
`
`Id. 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 id., 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 id., 1:30-38. Kontos 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.
`
`Id., 1:46-49; see also id., 2:16-22.
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`23. Figure 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 id., 1409 at 1:9-13.
`
`Id., 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).
`
`
`
`
`
`Id., Fig. 6C.
`
`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.” Id., 5:49-52.
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`26. Kontos describes a support assembly 10 that includes wire 14 and
`
`body 12. “Body 12 [] can be viewed as a mini guide catheter…” Id., 3:47-49. Body
`
`12 includes a tube 16 and soft tip 28. See id., Fig. 1, 3:45-55.
`
`Id., 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.
`Numerous other methods of connecting wire 14 to body 12 will readily
`occur to those skilled in the art.
`
`Id., 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
`
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`of a molded plastic material, such as polyethylene.” Id., 4:1-4. “[S]oft tip 28
`
`generally is cylindrical in shape and extends coaxially from distal end 24 of tube
`
`16.” Id., 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.,
`
`4:7-11.1
`
`B. Overview of Adams
`29. U.S. Patent Publication 2004/0010280 (“Adams”) published on
`
`January 15, 2004. Adams teaches a method and system for removing a coronary
`
`stenosis. Ex-1435.
`
`30. With reference to the excerpted Adams Fig. 1B, below, Adams
`
`describes using a guide catheter 10 that is advanced until its distal tip is in the
`
`ostium (“O” in Fig. 1B) of the coronary vessel (“V” in Fig. 1B). Id., [0012],
`
`[0059], [0061], [0064], Figs. 1B, 2A. A sealing device 20 is then advanced
`
`“through the lumen of the guide catheter until the distal sealing portion extends
`
`from the distal end of the guide catheter,” whereupon it occludes the flow of blood
`
`
`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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`though the vessel. Id., [0012], [0059], [0061], [0064], Figs. 2A-C. Then, a distal
`
`protection device 15 “mounted on an elongate support member 16” is “advanced
`
`across the lesion.” Id., [0059].
`
`
`
`Id., Fig. 1B.
`
`31. Figures 2A and 2C of Adams illustrate the sealing device 20 as it is
`
`advanced to the distal end of the guide catheter 10 (Fig. 2A at left) and beyond the
`
`distal end of the guide catheter 10 (Fig. 2C at right).
`
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`Id., Figs. 2A-C.
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`
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`32. The sealing device is characterized by a control wire 5 that is attached
`
`to the proximal end of the guide seal catheter 20. Id., [0060]. Control wire 5
`
`extends proximally and passes through a Y connector at hemostatic valve 9. Id.
`
`33. As can be seen in Adams Figures 2A and 2C, Adams has angled
`
`proximal opening. An angled proximal opening was a common feature of rapid-
`
`exchange-style catheters by May 3, 2006. Ex-1407, 4:11; Ex-1408, Figs.
`
`6A-E, 12:9-13:60; Ex-1418, Fig. 7; Ex-1432, 119, Fig. 1; Ex-1433, Fig. 2, [0035],
`
`[0049]; Ex-1435, [0066]; Ex-1450, Fig.7; Ex-1461, Fig. 1B, 6:9-11.
`
`C. Overview of Takahashi
`34. The article “New Method to Increase a Backup Support of a 6 French
`
`Guiding Coronary Catheter” by Takahashi et. al. (“Takahashi”), published in
`
`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.
`
`35. Before describing the teachings of Takahashi, I provide a brief
`
`background on the size of catheters and interventional devices. The French gauge
`
`size is a quantitative measure common in catheter design that was developed in the
`
`19th century. Ex-1462, 545. The “French size” (commonly abbreviated as “Fr”) is
`
`a standard unit of measure of the diameter of a catheter. One French equals
`
`1/3 mm. Id.
`
`36. A guide catheter must be small enough to fit in the artery of the
`
`patient yet big enough to accommodate interventional devices such as balloon
`
`catheters, and stents. As of May 3, 2006, guide catheters generally ranged in size
`
`from 5 French to 8 French. See Ex-1410, 453-54; Ex-1415, 548-49.
`
`37. For example, as described by Takahashi, the 5 Fr Heartrail catheter
`
`had an inner diameter of 0.059 inches (1.50 mm) (see Ex-1410, 452) and could
`
`accept “normal balloons or stent delivery systems less than 4.0 mm in diameter.”
`
`Ex-1410, 452 (The 4.0 mm diameter notation of the balloon or stent refers to its
`
`fully expanded size and not its size prior to inflation or expansion.); see also Ex-
`
`
`2 Vol. 63, pages 452-456.
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`1424, 2 (describing the Taxus rapid exchange delivered stent for use with a 5 Fr
`
`guide catheter (guide catheter inner diameter equal to or greater than 0.058 inches).
`
`38. Takahashi teaches inserting a 5 Fr guiding catheter with an inner
`
`lumen size of 0.059 inches into a 6 Fr guiding catheter with an inner lumen size of
`
`0.071 inches (“Figure 3B”). Ex-1410, 452, 454. The difference between the inner
`
`lumen diameters of the two guiding catheters is 0.012 inches (0.30 mm), which is
`
`not more than one French size3 in difference. Id.
`
`39. Once the 6 Fr guiding catheter is placed at the ostia of the coronary
`
`artery (“Figure 3E”), Takahashi teaches to extend the 5 Fr guiding catheter beyond
`
`the distal end of the 6 Fr guiding catheter and into the coronary artery. Id., 454.
`
`Then, Takahashi places the balloon at the lesion with the advantage of the
`
`additional backup support provided by the extension of the 5 Fr guiding catheter.
`
`Id.
`
`
`3 One French equals 1/3 of a millimeter or 0.33 mm.
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`Id., Figs. 3A-F.
`
`D. Overview of Common Knowledge Related to Flexibility and
`Reinforcement
`40. Guide catheters are designed with regions of specific flexibilities in
`
`order to tailor the performance of the guide catheter. See e.g., Ex-1451 (U.S. Pat.
`
`No. 5,911,715 to Berg (“Berg”)), 1:21-25. Certain criteria must be met by any
`
`device that is inserted into the vasculature and traverses the anatomy from the
`
`groin to the heart (or from the wrist to the heart, in the case of radial artery access).
`
`The criteria include the following.
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`1.
`
`First, the device must be flexible enough to traverse the curves
`
`and bends of the patient’s vasculature.
`
`2.
`
`3.
`
`Second, the device must not damage the vasculature.
`
`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.
`
`41. By May 3, 2006, it was well known that a balance between flexibility,
`
`rigidity, and atraumatic properties must be maintained when designing a PTCA
`
`catheter. Numerous teachings of this balance of features existed in the art at this
`
`time. Ex-1415, 549; Ex-1451, 2:35-46; see generally, Ex-1407; Ex-1408; Ex-1409.
`
`42. For example, it was known in the art that the distal tip of a catheter
`
`should be soft. Guide catheters, for example, included “a very soft material in the
`
`most distal 2 mm of the catheter to reduce the chance of vessel trauma.”
`
`Ex-1415, 549. Similarly, the distal end of PTCA catheters were “made to be
`
`extremely soft and flexible so as to facilitate its passage through tortuosities and
`
`restrictions in the vascular system.” Ex-1409, 1:30-33. And support catheters
`
`designed to extend beyond the distal tip of a guide catheter were also designed to
`
`“have a soft tip.” Id., 2:51-54, 4:5-7. For example, as Kontos describes, a soft tip
`
`could be made of a soft plastic, such as “a copolymer of polyethylene and ethyl-
`
`vinylalcohol (EVA).” Id., 4:7-11.
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`43. More generally, it was known in the art that in order for coronary
`
`catheters to safely traverse the vasculature, the preferred material used to form the
`
`catheter should either be a polymer or a material coated with a polymer. See, e.g.,
`
`Ex-1407, 3:30-37, 3:50-58; Ex-1408, 6:37-46, 6:63-67. Most commonly around
`
`2000, guide catheters were formed of either polyethylene (Cook Inc.,
`
`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, 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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`44.
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`In order to achieve the proper balance of rigidity and flexibility, it was
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`common in the art to reinforce a catheter’s lumen. See Ex-1415, 549; Ex-1451,
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`Fig. 19, 13:66-14:67. The reason for the varying rigidity, as mentioned above, is
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`4 See https://www.ptonline.com/knowledgecenter/profile-extrusion/glossary-of-
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`terms (last accessed July 24, 2020). 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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`that portions of the catheter must be flexible to navigate the curves of a patients
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`anatomy, and portions must be soft enough that they are atraumatic to the
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`vasculature (e.g., the distal tip), but portions must be rigid enough such that a
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`physician can transmit longitudinal and rotational forces to the catheter in order to
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`locate the catheter to the target lesion. See Ex-1451 at 1:49-51.
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`45. By the late 1990s, Berg discusses that it was common practice to add
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`metal braiding or metal coils to the tubular structure of catheters “[t]o accomplish
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`this balance between longitudinal rigidity, torsional rigidity, and flexibility.”
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`Ex-1451, 1:56-59. Berg states:
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`This Support member is often comprised of a metal braid or coil
`embedded in the shaft. This support wire is often embedded in the shaft
`between the two layers of tubing that comprise the shaft.
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`Id., 1:59-62. Note that “shaft” as used in Berg refers to the tubular structure
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`of the lumen.
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`46. Not surprising, many references disclose the practice of strategically
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`locating metal reinforcements within the tubular structure of a catheter and discuss
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`using a metal reinforcement to resist kinking. See Ex-1407, 2:15-21; see also
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`Ex-1408, 7:3-6, 7:19-28, 23:53-58.
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`47. Mihara also teaches the common practice of using metal
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`reinforcement in the shape of braiding and coiling as well as reinforcing with a bar-
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`shaped structure. See Ex-1433, [0053] (“In this embodiment, the reinforcing body
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`34 is a spiral coil composed of tungsten. The reinforcing body 34 is placed in such
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`a manner that the reinforcing body 34 is buried in the outer layer 33 (or the inner
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`layer 32). The reinforcing body 34 is not limited to a spiral coil, and may be a
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`braided body (net-shaped body), a bar-shaped body, or the like. Its material is not
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`limited to tungsten. The reinforcing body 34 may be made of stainless steel or the
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`like.”).
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`48. Further, Dinh teaches that a metal braid reinforcement in a catheter
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`enables a small outer diameter as compared to a relatively large inner diameter at
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`the same time as maintaining kink resistance, flexibility and torqueability.
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`Ex-1446, 2:17-26, 1:37-47.
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`49. Truckai teaches that the same mechanical properties can be achieved
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`in a thin-walled catheter with braiding as a thick catheter made solely of polymer.
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`Ex-1447, Abstract, 4:10-26. By embedding the braid elements within the polymer
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`wall of the catheter, even thinner catheters can be achieved. Id.
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`50. Adams also teaches that a coil reinforcement or a braided
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`reinforcement can be used in its guide seal. See Ex-1435, [0075].
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`51. Reinforcing a catheter with metal braiding or metal coiling imparted
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`enough strength in a catheter lumen to enable a physician to transmit longitudinal
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`and torsional forces without the lumen kinking. Due to the open structural nature
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`of a braid or coil, a catheter containing such reinforcement maintains enough
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`flexibility for the lumen to bend around curves in a patient’s anatomy.
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`52. Therefore, it is clear that metallic braiding or coiling was ubiquitous
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`by May 3, 2006 and was known to prevent or impart kink-resistance, thereby
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`improving the pushability of the extension catheter.
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`VI. KONTOS DISCLOSURE
`I have been asked to provide my expert opinion as to whether certain
`53.
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`features/teachings are found in Kontos or Kontos in combination with other prior
`
`art. It is my opinion that Kontos discloses, or Kontos in combination with the art
`
`described herein, teaches the following.5
`
`A. Kontos discloses that the support assembly 10 in combination
`with guide catheter 38 provides backup support to an
`interventional cardiology device for use in the coronary
`vasculature.
`54. Kontos discloses that the support assembly 10 in combination with
`
`guide catheter 38 assists in resisting axial and shear forces exerted by an
`
`interventional cardiology device that tend to dislodge a guide catheter from a
`
`
`5 The teachings discussed herein are not exhaustive of all the teachings found in the
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`prior art. I reserve the right, if asked, to provide my opinion on additional teachings
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`found in the prior art.
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`branch artery. In other words, the support assembly 10 in combination with guide
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`catheter 38 provides backup support for an interventional cardiology device for use
`
`in the coronary vasculature.
`
`55. Kontos discloses that a physician inserts a guide catheter 38 through
`
`the aorta 37 and into a patient’s coronary ostia 39 using known medical
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`procedures.” Ex-1409, at 5:11-15. Kontos further provides that “the support
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`catheter can be inserted into and passed through a guide catheter, over a PTCA
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`catheter, and out the distal end of the guide catheter so as to function as an
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`extension of the guide catheter to bridge the gap (or at least some of it) between the
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`end of the guide catheter and the stenosis to be opened.” Id., 2:16-24. As shown in
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`Figures 6B-C (below), the distal portion of support catheter 10 is extended beyond
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`the distal end of guide catheter 38. In so doing, a proximal portion of tube 16 of
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`support catheter 10 remains within guide catheter 38. It is this
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`relationship/positioning between support catheter 10 and guide catheter 38 that
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`resists axial and shear forces that are exerted when an interventional cardiology
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`device, such as PTCA catheter 40 with balloon 48, passes through and beyond the
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`catheter assembly (i.e., through the lumen of the extension catheter that is
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`positioned within the lumen of the guide catheter) into the branch artery.
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`Id., Figs. 6B-C.
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`56. Figure 14 of Kontos (at left) illustrates the assembly configuration of
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`Kontos’s teaching. Figure 3 from Takahashi (at right) illustrates a similar assembly
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`
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`configuration.
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`
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`Ex-1409, Fig. 14
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`Ex-1410, Fig. 2B
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`57. Since Takahashi and Kontos have the same configuration, a POSITA
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`would appreciate that Kontos provides backup support and resists axial and shear
`
`stresses that normally dislodge a guide catheter in the same manner that
`
`Takahashi’s configuration does. See Ex-1410, 452 (teaching that a
`
`mother-and-child catheter configuration increases backup support). That is, when
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`the support assembly 10 of Kontos is used in combination with a guide catheter 38,
`
`the combined catheter assembly will resist axial and shear forces—including a
`
`backward force that is applied to, among other places, the proximal portion of the
`
`extension catheter—exerted by the interventional cardiology device that tend to
`
`dislodge the guide catheter and/or extension catheter.
`
`58. Since the tube 16 and soft tip 28 are part of the support assembly 10
`
`and work in conjunction with the guide catheter, so too, does the soft tip 28 of
`
`Kontos resist axial and shear forces.
`
`59. For this reason, a POSITA would appreciate that Kontos discloses that
`
`the support assembly 10 in combination with guide catheter 38 assists in resisting
`
`axial and shear forces exerted by an interventional cardiology device that tend to
`
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`dislodge a guide catheter from a branch artery.6 In other words, the support
`
`assembly 10 in combination with guide catheter 38 provides backup support for an
`
`interventional cardiology device for use in the coronary vasculature.
`
`B. Kontos in combination with Adams teaches increasing the inner
`diameter of Kontos’s tube 16 to deliver a great