`
`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.: IPR2020-01344
`U.S. Patent No: RE46,116
`
`
`
`DECLARATION OF STEPHEN JON DAVID BRECKER,
`MD, FRCP, FESC, FACC
`
`
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`IPR2020-01344
`Patent RE46,116
`
`TABLE OF CONTENTS
`
`
`Page
`Introduction ..................................................................................................... 1
`I.
`II. Qualifications .................................................................................................. 1
`III. Summary of Opinions ..................................................................................... 3
`IV. Legal Standards .............................................................................................. 4
`A.
`Claim Construction .............................................................................. 4
`B. Obviousness .......................................................................................... 5
`Person of Ordinary Skill in the Art ................................................................. 6
`V.
`VI. Overview of the Technology .......................................................................... 7
`A. History of Percutaneous Coronary Interventional Procedures ............. 8
`B. History of Percutaneous Coronary Interventional Procedures ........... 10
`C.
`Basic tools of percutaneous coronary intervention ............................ 12
`1.
`PCI: Guide catheter .................................................................. 13
`2.
`PCI: Guidewire ........................................................................ 19
`3.
`PCI: Therapeutic devices ......................................................... 20
`4.
`PCI: Additional backup support .............................................. 22
`5.
`PCI: Mother and child catheter systems .................................. 24
`6.
`PCI: Over-the-wire versus Rapid Exchange ............................ 29
`7.
`PCI: Proximal openings on child catheter ............................... 34
`8.
`PCI: Interventional cardiology in the early 2000s ................... 44
`VII. The ’116 Patent ............................................................................................. 46
`A.
`Claims of the ’116 Patent Considered ................................................ 46
`B.
`File History of the ’116 Patent ........................................................... 46
`C.
`Summary of the ʼ116 Patent ............................................................... 47
`VIII. Claim Construction ....................................................................................... 50
`IX. Overview of the References ......................................................................... 51
`A. Kontos (Ex-1409) ............................................................................... 51
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`IPR2020-01344
`Patent RE46,116
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`TABLE OF CONTENTS
`(continued)
`
`X.
`
`Page
`Ressemann (Ex-1408) ........................................................................ 54
`B.
`Takahashi (Ex-1410) .......................................................................... 55
`C.
`D. Kataishi (Ex-1425) ............................................................................. 57
`Claims 25-40, 42, 44-48, and 52-53 of the ’116 Patent are Invalid as
`Obvious. ........................................................................................................ 59
`A. Kontos Renders Claims 52-53 Obvious in View of Ressemann
`and/or the Knowledge of a POSITA. ................................................. 59
`B. Kontos Renders Claims 25-40, 42, and 44-48 Obvious in View
`of Ressemann, Takahashi, and/or the Knowledge of a POSITA. ...... 77
`C. Kontos Renders Claim 45 Obvious in View of Ressemann,
`Takahashi, Kataishi, and/or the Knowledge of a POSITA. ............. 108
`XI. The Challenged Claims are Further Invalid if Root is Prior Art ................ 111
`A.
`Root .................................................................................................. 111
`B.
`Root and the Knowledge of a POSITA Renders Claims 25-55
`Obvious. ........................................................................................... 112
`C. Kontos Renders Claim 45-46 Obvious in View of Ressemann,
`Takahashi, Root, and/or the Knowledge of a POSITA. ................... 126
`XII. Conclusion .................................................................................................. 129 
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`IPR2020-01344
`Patent RE46,116
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`TABLE OF EXHIBITS
`
`
`Exhibit Description
`1401 U.S. Patent No. RE 46,116 (“the ’116 patent”)
`1402
`File history for U.S. Patent No. 8,292,850
`1403
`File history for U.S. Patent No. RE 46,116
`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”)
`1413 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1414 Meads, C., et al., Coronary artery stents in the treatment of ischaemic
`heart disease: a rapid and systematic review, Health Technology
`Assessment 2000 4(23) (“Meads”)
`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”)
`1425 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1426 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1428 Baim, Randomized Trial of a Distal Embolic Protection Device
`During Percutaneous Intervention of Saphenous Vein Aorto-Coronary
`Bypass Grafts, Circulation 105:1285-1290 (2002) (“Baim”)
`Limbruno, Mechanical Prevention of Distal Embolization During
`Primary Angioplasty, Circulation 108:171-176 (2003) (“Limbruno”)
`1430 U.S. Patent No. 5,413,560 (“Solar ’560”)
`
`1429
`
`1415
`
`iii
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`IPR2020-01344
`Patent No. RE46,116
`
`1440
`
`1441
`
`Exhibit Description
`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”)
`1436 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1438 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1439 Urban et al., Coronary stenting through 6 French Guiding Catheters,
`Catheterization and Cardiovascular Diagnosis (1993) 28:263-266
`Excerpt of McGraw-Hill Dictionary of Scientific and Technical Terms
`(5th edition) (1994) (defining “flexural modulus”)
`Excerpt from Kern’s The Interventional Cardiac Catheterization
`Handbook (2nd edition) (2004) (chapter 1)).
`1442 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1446 U.S. Patent No. 6,042,578 (“Dinh”)
`1447 WO 97/37713 (“Truckai”)
`1450 U.S. Patent No. 5,980,486 (“Enger”)
`1451 U.S. Patent No. 5,911,715 (“Berg”)
`1453 U.S. Patent No. 5,720,300 (“Fagan”)
`1454 U.S. Patent No. 5,120,323 (“Shockey”)
`1455
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1457 U.S. Patent No. 5,445,625 (“Voda”)
`1458 U.S. Patent No. 6,595,952 (“Forsberg”)
`1459 U.S. Patent No. 6,860,876 (“Chen”)
`
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`IPR2020-01344
`Patent No. RE46,116
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`Exhibit Description
`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)
`1470 Metz, Comparison of 6f with 7f and 8f guiding catheters for elective
`coronary angioplasty: Results of a prospective, multicenter,
`randomized trial, American Heart Journal. Vol. 134, Number 1, pp
`132-137 (“Metz”)
`Feldman, Coronary Angioplasty Using New 6 French Guiding
`Catheters, Catheterization and Cardiovascular Diagnosis 23:93-99
`(1991) (“Feldman”)
`Excerpt of Patrick W. Serruys, Handbook of Coronary Stents (4th
`Edition) (2002)
`1509 Mamas A. Mamas, Distal Stent Delivery with the Guideliner Catheter:
`First in Man Experience (2010)
`1512 U.S. Patent Application Publication US2017/0260219 (“Root”)
`
`
`1497
`
`1471
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`IPR2020-01344
`Patent RE46,116
`I.
`Introduction
`1.
`I have been retained by Robins Kaplan LLP on behalf of Medtronic,
`
`Inc. and Medtronic Vascular, Inc. (“Medtronic”) as an independent expert to
`
`provide my opinions on the subject matter recited in U.S. Patent No. RE46,116.
`
`2.
`
`I understand that Medtronic is petitioning the Patent Trial and Appeal
`
`Board (“PTAB”) to institute Inter Partes Review (“IPR”) of U.S. Patent No.
`
`RE46,116, and will be requesting that the PTAB cancel all challenged claims of
`
`these patents due to anticipation and/or obviousness.
`
`3.
`
`I make this declaration based on personal knowledge. I am over the
`
`age of 21 and am otherwise competent to make this declaration.
`
`II. Qualifications
`4.
`I am an interventional cardiologist who has been the Chief of
`
`Cardiology at St. George’s University Hospitals London, U.K. since 2015.
`
`5.
`
`I graduated from St. Thomas’ Hospital Medical School, London, in
`
`1984. I completed senior house officer posts at the Hammersmith Hospital, the
`
`Brompton Hospital, and the National Hospital for Nervous Diseases. I then
`
`completed registrar training in cardiology at St. Thomas’ Hospital and the London
`
`Chest Hospital before becoming a British Heart Foundation Junior Research
`
`Fellow at the Royal Brompton Hospital. I was a visiting fellow at Johns Hopkins
`
`Hospital in Baltimore before becoming a Consultant Cardiologist and Honorary
`
`
`
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`Senior Lecturer at St. George’s in 1996. I am now a Professor of Cardiology and
`
`Chief of Cardiology Clinical Academic Group at St. George’s University
`
`Hospitals.
`
`6. My full qualifications are set forth in my CV, submitted herewith as
`
`Exhibit 1006.
`
`7.
`
`I have been a practicing, interventional cardiologist for over 24 years.
`
`At my peak, I performed 300-350 coronary stenting procedures per year.
`
`8.
`
`I have proctored over 1,000 coronary stenting procedures in which I
`
`assisted and taught other physicians how to perform coronary stenting.
`
`9.
`
`I am a named inventor on one U.S. patent, describing a percutaneous
`
`guidewire, and, additionally, on patent applications related to replacement heart
`
`valves.
`
`10.
`
`I am a Fellow of the Royal College of Physicians, the European
`
`Society of Cardiology, the American College of Cardiology, the British
`
`Cardiovascular Society, and the British Cardiovascular Intervention Society.
`
`11.
`
`I am the author or co-author of four books, 24 book chapters, and
`
`more than 100 peer-reviewed articles.
`
`12. For my time, I am being compensated at $800 per hour, my standard
`
`rate for this type of consulting activity. My compensation is in no way contingent
`
`on the results of these or any other legal proceedings.
`
`
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`III. Summary of Opinions
`13.
`I am informed by counsel that RE46,116 (“the ’116 patent”) is one
`
`patent in a family of patents that is owned by Teleflex, which include U.S. Patent
`
`Nos. 8,048,032; RE,45,760; RE45,776; RE47,379; and 8,142,413. Herein, I will
`
`refer to this patent family as the “Teleflex family” or the “Teleflex patents.” I have
`
`been informed that the Teleflex patents have been asserted against Medtronic in the
`
`United States District Court for the District of Minnesota.
`
`14. All of the opinions contained in this Declaration are based on the
`
`documents I reviewed and my knowledge and experience. In forming the opinions
`
`expressed in this Declaration, I reviewed the ’116 patent (Ex-1401), and the file
`
`history of the ’116 (Ex-1403). I have also reviewed U.S. Pat. No. 5,439,445
`
`(“Kontos”) (Ex-1409); U.S. Pat. No. 7,604,612 (“Ressemann”) (Ex-1408); New
`
`Method to Increase a Backup Support of a 6 French Guiding Coronary Catheter,
`
`Catheterization and Cardiovascular Interventions 63:452-456 (2004) (“Takahashi”)
`
`(Ex-1410); U.S. Patent Application Publication 2005/0015073 (“Kataishi”)
`
`(Ex-1425); U.S. Pat. No. 5,980,486 (“Enger”) (Ex-1450); and the other material
`
`referred to herein.
`
`15. My opinions have also been guided by my appreciation of how a
`
`person having ordinary skill in the art would have understood the claims and the
`
`specification of the ’116 patent at the time of the alleged invention.
`
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`16.
`I understand the ’116 patent reissued from the ’850 patent, which
`
`issued from an application initially filed on May 3, 2006. I have been asked to
`
`initially consider the time of the alleged invention as of May 3, 2006. My opinions
`
`reflect how a person of ordinary skill in the art would have understood the ’116
`
`patent, prior art to the ’116 patent, and the state of the art at the time of the alleged
`
`invention. In 2006, the vast majority of my catheter lab practice was in the field of
`
`coronary intervention.
`
`17. Based on my experience and expertise and the materials I have
`
`reviewed, it is my opinion that certain prior art references teach or suggest all of
`
`the features recited in claims 25-40, 42, 44-48, and 52-53 of the ’116 patent.
`
`18.
`
`It is my opinion that claims 25-40, 42, 44-48, and 52-53 of the ’116
`
`patent are invalid as anticipated and/or obvious.
`
`IV. Legal Standards
`19.
`I am not a lawyer and have been informed by counsel of the legal
`
`standards set forth herein.
`
`A. Claim Construction
`I understand that patent claims are to be interpreted in light of a
`
`20.
`
`patent’s specification and prosecution history. I am informed that claim
`
`construction starts with the plain language of the claims as understood by a person
`
`having ordinary skill in the art at the time the patent was filed.
`
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`21. For any claim terms not explicitly noted as construed, I have applied
`
`the terms’ plain and ordinary meanings as would be understood by a person of
`
`ordinary skill in the art in 2006.
`
`B. Obviousness
`I understand that under U.S. Patent Law, 35 U.S.C. §103, a claim is
`
`22.
`
`invalid as obvious if the differences sought to be patented and the prior art are such
`
`that the subject matter as a whole would have been obvious at the time the
`
`invention was made to a person having ordinary skill in the art to which said
`
`subject matter pertains.
`
`23.
`
`I am informed that an obviousness analysis requires an assessment of
`
`the scope and content of the prior art, the differences between the art and the
`
`claims at issue, and the level of ordinary skill in the art. I am told that it is against
`
`this backdrop that obviousness is assessed.
`
`24.
`
`I am also informed that there may be objective indicia of non-
`
`obviousness, or secondary considerations that must be considered when present. I
`
`understand that secondary considerations may be used to rebut a prima facie
`
`showing of obviousness.1
`
`
`1 To date, I am unaware of any objective indicia of non-obviousness. I understand
`
`that in the Institution Decisions of co-pending IPRs, the Board stated that Patent
`
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`25.
`I understand that 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.
`
`26.
`
`I am informed that a POSITA is a hypothetical person who
`
`is presumed to be aware of all the pertinent prior art. I am also informed that an
`
`obviousness analysis may take account of the inferences and creative steps that a
`
`person of ordinary skill in the art would employ.
`
`V.
`
`Person of Ordinary Skill in the Art
`27.
`If a POSITA at the time of the alleged invention 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. Ex-1442, ¶ 25.
`
`
`Owner failed to establish nexus between the purported objective indicia of non-
`
`obviousness and the Challenged Claims. To the extent that the Patent Owner offers
`
`any in connection with these proceedings, I will respond to them as appropriate.
`
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`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.
`
`VI. Overview of the Technology
`28. The technology claimed in the ’116 patent relates to interventional
`
`cardiology procedures using catheters. See Ex-1401, Abstract, 1:36-37. Catheters
`
`are tube-like members inserted into the body for diagnostic or therapeutic medical
`
`reasons. The hollow portion of a catheter is often referred to as a “lumen.”2 In
`
`particular, the technology of the ’116 patent relates to catheters inserted into the
`
`coronary arteries from the aorta. In the context of the ’116 patent, a catheter
`
`functions as a tool to help a physician treat coronary conditions such as coronary
`
`artery disease, in which cardiac blood flow is restricted because of the buildup of
`
`arterial plaque.
`
`29.
`
`In the 1960s, prior to the development of catheter-based intervention,
`
`physicians attempting to treat coronary artery disease due to restricted coronary
`
`blood flow often relied on drug therapy and coronary artery bypass grafts
`
`(“CABG”). Ex-1414, 2. A drawback of CABG is that it requires open-heart
`
`
`2 Lumen is also used to refer to the blood-filled interior of the artery.
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`surgery. In order to avoid the risks and complications of open-heart surgery, the
`
`medical community searched for less invasive techniques.
`
`A. History of Percutaneous Coronary Interventional
`Procedures
`In general, percutaneous coronary interventional procedures refer to
`
`30.
`
`the use of catheter-based technology to treat coronary artery disease, wherein the
`
`catheter is introduced into a patient’s vasculature utilizing a sheath placed in a
`
`peripheral artery, alleviating the need for open-heart surgery.
`
`31. As depicted below, in patients with coronary artery disease, plaque
`
`buildup narrows the arterial lumen, and this narrowing is also referred to as a
`
`“stenosis.” If plaque buildup is not alleviated, the coronary artery may become
`
`completely blocked. In either instance, blood flow is reduced. Complete
`
`obstruction of a blood vessel can lead to a heart attack or stroke.
`
`32. Catheter-based technology, such as the technology described in the
`
`’413 patent, is used by interventional cardiologists to help remedy these conditions
`
`
`
`and restore unrestricted blood flow.
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`33. To better describe the ’116 patent’s alleged invention, I briefly
`
`describe the advances in interventional cardiology (and in particular the use of
`
`catheter-based technology3). It is important to keep in mind that while catheter-
`
`based technology has advanced, many of the key foundational components of
`
`catheters have undergone little change over the years. For example, components
`
`such as guide catheters, guidewires, and angioplasty balloons function in the same
`
`or similar ways as they did when catheters were first introduced.
`
`34. Catheter-based therapies are less invasive than open-heart surgery
`
`because the catheters are introduced into the vasculature percutaneously. The
`
`procedure begins with a hollow needle puncture in an artery in the leg (femoral
`
`artery) or the wrist (radial artery) to gain access to the patient’s vasculature.
`
`Through the hollow needle, a typically short 0.035 guidewire is introduced into the
`
`patient’s artery. The needle is then removed and an introducer sheath is inserted
`
`
`3 While I largely focus on the use of balloon angioplasty and stents to displace plaque
`
`in the arteries to alleviate blood flow restrictions, it is worth noting that other,
`
`catheter-based interventional techniques are known that rely on removing plaque
`
`from the vessel walls. These include atherectomy, laser ablation, and mechanical
`
`thrombectomy. Ex-1415, 601-36. None of these techniques “cure” coronary artery
`
`disease.
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`over the short 0.035 guidewire and into the artery. Once the introducer sheath is
`
`placed, the short 0.035 guidewire is removed and a longer 0.035 guidewire and
`
`guide catheter are introduced into the artery and pushed through the artery until the
`
`0.035 guidewire and guide catheter are positioned in the ascending aorta.
`
`35. The guide catheter includes a hemostatic valve coupled to the
`
`proximal hub of the guide catheter. This valve may also be referred to as a
`
`“hemostasis valve” or a “Tuohy-Borst valve.” Hemostatic valves—that have been
`
`used since at least the 1970s (Ex-1465)—enable the introduction of a variety of
`
`devices into the patient’s artery, including guidewires, catheters and stents.
`
`Hemostatic valves are the standard of care in PCI procedures. Ex-1415, 557. No
`
`responsible physician would perform a PCI procedure without a hemostatic valve
`
`because it is the valve that (i) prevents blood loss and (ii) prevents air from
`
`entering the body (causing an air embolism). Ex-1435, [0060].
`
`B. History of Percutaneous Coronary Interventional
`Procedures
`Initially, coronary catheters were widely used for diagnostic purposes.
`
`36.
`
`But, in the 1980s, physicians had begun to employ catheter-based interventional
`
`procedures, which, collectively, can be referred to as PCI procedures.
`
`37. The initial PCI procedures involved the use of a balloon catheter to
`
`widen coronary arteries, using a procedure called “balloon angioplasty,” or
`
`“percutaneous transluminal coronary angioplasty (“PTCA”). Ex-1415, 547. As
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`depicted below, physicians could insert a balloon catheter into the body through
`
`either the wrist/arm or groin of a patient, and then— using fluoroscopic
`
`screening—guide the balloon catheter to the target lesion. Ex-1414, 3. Upon
`
`reaching the target lesion, a physician could then inflate the balloon catheter. Id.
`
`The inflation of the balloon increases blood flow by displacing the plaque and
`
`increasing the size of the vessel’s lumen. Ex-1415, 562.
`
`
`
`38. While balloon angioplasty has its use, it also has particular risks
`
`associated with it. These risks include the potential for abrupt vessel closure
`
`(which used to require emergency bypass in about 1% of patients) and the risk of
`
`restenosis (e.g., the recurrence of stenosis after the balloon angioplasty procedure
`
`is completed). Id., 637. About 30% of patients who experience restenosis will need
`
`repeat balloon angioplasty. Id. In addition, when the plaque is displaced, there is
`
`the risk that it will be dislodged and embolize distally. It is also recognized that
`
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`thrombus can form in these circumstances and itself embolize elsewhere in the
`
`patient’s vasculature.
`
`39. Because of the risks associated with balloon angioplasty, physicians
`
`started developing and using stents. A stent, as depicted below, is a wire mesh tube.
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`“Stenting” refers to the placement of a stent within an artery. A stent functions to
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`prop open the artery and alleviate the restricted blood flow. In order for a stent to
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`reach the target site, a physician uses a catheter-based system to guide and place
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`the stent at the target site.
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`40. Between the late 1980s and the late 1990s, stents evolved to be more
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`flexible, and to include lower profile delivery systems. Ex-1438, 133-134. This
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`meant that stents could be delivered to more distal locations in the coronary
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`vessels. By 2000, stents were used in greater than 80% of PCI procedures.
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`Ex-1415, 637.
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`C. Basic tools of percutaneous coronary intervention
`41. While coronary angioplasty systems were initially developed over 40
`
`years ago, the basic components of PCI systems have only changed a little. They
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`routinely utilize a guide catheter, a guidewire, and device therapy catheter (e.g., a
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`balloon catheter or a stent). Id., 548. While I discuss these components in more
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`detail below, I also provide a modified image from U.S. Pat. No. 5,720,3004 to
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`Fagan et al. (“Fagan”) (see below) as guidance. See Ex-1453.
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`Id., Fig. 1 (color and annotations added).
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`1.
`PCI: Guide catheter
`42. A guide catheter is a hollow tube with a lumen that permits passage of
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`the guidewire and the device therapy catheter. The distal end of a guide catheter is
`
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`4 U.S. Pat. No. 5,720,300 to Fagan et al. (“Fagan”) issued Feb. 24, 1998.
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`typically placed in the ostium (opening) of a coronary artery, but not advanced
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`more than a few mm into the coronary artery.
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`43. Since 2000, a guide catheter has often included:
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`a. an inner diameter of a size sufficient to allow passage of a
`therapeutic device;
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`b. an inner lining to reduce friction, such as Teflon;
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`c. a metal or plastic braid or coil to transmit torque and provide
`sufficient stiffness to offer backup support during device
`advancement; and
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`d. a smooth outer coating to resist thrombus formation. (Ex-1415,
`548-49.)
`
`
`44. The figure below illustrates a typical guide catheter configuration
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`available in the late 1990s and early 2000s. See Ex-1451, Fig. 5.5
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`Id.
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`45. Overall, a guide catheter is a hollow tube that must be (a) big enough
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`to allow for the delivery of a therapeutic device to the target site; (b) small enough
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`
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`5 U.S. Pat. No. 5,911,715 to Berg et al., issued June 15, 1999.
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`to introduce into the ostium of a coronary artery; (c) flexible enough to navigate
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`through the vasculature; and (d) rigid enough to provide support for the
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`deployment a therapeutic device.
`
`46. The basic unit of measure used throughout the industry to measure the
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`size of a catheter is “French size.”6 In the early 1980s, the 9 French inner-diameter
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`catheters predominated. Ex-1415, 549. In the 1990s, 7 French or 8 French guiding
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`catheters were typically used. Ex-1470, 131; Ex-1471, 94 (describing 8 French as
`
`conventional). By the 2000s, the inner diameter of guide catheters typically ranged
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`from 5 French to 8 French. See Ex-1410, 453-54; Ex-1415, 548-49.
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`47. Standard guide catheters must be sized so that therapeutic devices can
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`be passed through their inner lumen. As of 2004, the 5 Fr Heartrail catheter had an
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`inner diameter of 0.059 inches (1.50 mm) and could accept “normal balloons or
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`stent delivery systems less than 4.0 mm in diameter.” Ex-1410, 452. The 4.0 mm
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`diameter notation of the balloon or stent refers to its fully expanded size and not its
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`size prior to inflation or expansion.
`
`48. At the time of the Teleflex family filing, the trend in the field of
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`interventional cardiology was to reduce the crossing profile size of balloon catheters
`
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`6 French size is commonly abbreviated as “Fr.” One French equals 1/3 mm.
`
`Ex-1462, 545.
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`and stents in order to reduce trauma to the vasculature and to permit use of radial
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`(wrist) access sites. See Ex-1415, 549.
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`49. Guide catheters have varying rigidity along their length. Ex-1415,
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`549. The distal tip (generally the last 2 mm) of a guide catheter was flexible and
`
`soft, to minimize the risk of vessel trauma as the catheter was inserted to a desired
`
`location. Id. The catheter’s rigidity increased moving proximally, from its distal
`
`tip.
`
`50. More specifically, it was known in the art to design guide catheters
`
`along their length with regions of varying flexural moduli in order to optimize the
`
`ability to push and position a guide catheter, navigate complex anatomy such as the
`
`aortic arch, yet impart no trauma to the vasculature. I understand that flexural
`
`modulus is a material property that expresses the tendency of a material to resist
`
`bending. Ex-1442, ¶ 96.
`
`51. By the 1990s, it was known to design guide catheters such that the
`
`distal tip was the most flexible portion and increase the rigidity of the catheter in a
`
`proximal direction from the distal tip. For example, U.S. Pat. No. 5,911,715
`
`(“Berg”), teaches that an atraumatic soft tip of a guide catheter should have a
`
`flexural modulus of about 1000 to about 15,000 PSI. Ex-1451, 14:6-7. It was also
`
`known, moving in a distal to proximal direction along the guide catheter, that the
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`flexural moduli would increase to greater values in order to provide optimum
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`backup support and stability. See id., Fig. 19, 13:53-14:7, Abstract.
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`52. The figure below shows a distal portion of the Berg guide catheter
`
`with the flexural moduli teachings for each segment of varying rigidity in the distal
`
`portion to proximal direction.
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`
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`Id., Fig. 19 (color and annotations added).
`
`53.
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`In summary, moving from distal to proximal in Fig. 19, the first
`
`flexural modulus portion 140 is taught to be between 1,000 and 15,000 psi; the
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`second flexural modulus portion 142 is taught to be between 2,000 and 49,000 psi;
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`the third flexural modulus portion 144 is taught to be between 13,000 and 49,000
`
`psi; the fourth flexural modulus portion 146 is taught to be greater than 49,000 psi;
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`and the fifth flexural modulus portion 148 is taught to be between 29,000 and
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`67,000 psi. Id., 14:21-60.
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`54. The most proximal end of the guide catheter (the portion outside of
`
`the body) would contain a hemostatic valve that prevents blood from flowing out
`
`of the body, and air from being introduced into the blood stream, while enabling
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`introduction or withdrawal of devices into or out of the guide catheter. See ¶ 35,
`
`supra.
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`55. For a guide catheter to provide support for advancing therapeutic
`
`devices, it must provide enough “backup” support when the guide wire and therapy
`
`device are advanced distal to the guide catheter and push through a potentially tight
`
`stenosis. Ex-1415, 550. Without the support of the guide catheter, the therapeutic
`
`device may fail to push through the blockage and fail to reach the target site. The
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`schematic, below, illustrates the commonly known dislodgement of a guide
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`catheter due to the push back forces created when either a guidewire or therapeutic
`
`device meet resistance when crossing a lesion. The schematic is taken from U.S.
`
`Pat. No. 5,445,625 to Voda (“Voda”), which is