UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.,
`Petitioner,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`Case No.: IPR2020-00131
`U.S. Patent No: RE45,380
`
`DECLARATION OF STEPHEN JON DAVID BRECKER,
`MD, FRCP, FESC, FACC
`
`Page 1
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`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`I.
`Qualifications ................................................................................................... 1
`II.
`Summary of Opinions ...................................................................................... 3
`III.
`IV. Legal Standards ............................................................................................... 4
`A.
`Claim Construction ................................................................................... 5
`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 ................................. 13
`1.
`PCI: Guide catheter ............................................................................14
`2.
`PCI: Guidewire ..................................................................................19
`3.
`PCI: Therapeutic devices ...................................................................20
`4.
`PCI: Additional backup support .........................................................23
`5.
`PCI: Mother and child catheter systems ............................................25
`6.
`PCI: Over-the-wire versus Rapid Exchange ......................................30
`7.
`PCI: Proximal openings on child catheter .........................................35
`8.
`PCI: Interventional cardiology in the early 2000s .............................45
`VII. The ’380 Patent ..............................................................................................47
`A.
`Claims of the ’380 Patent Considered .................................................... 47
`B.
`File histories of the ’380 and ’850 patents.............................................. 47
`C.
`Summary of the ’380 patent.................................................................... 47
`VIII. Claim Construction ........................................................................................51
`IX. Overview of the References ..........................................................................57
`A. Kontos (Ex-1809) ................................................................................... 57
`B.
`Adams (Ex-1835) .................................................................................... 59
`C.
`Takahashi (Ex-1810) ............................................................................... 61
`D.
`Berg (Ex-1851) ....................................................................................... 62
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`Kataishi (Ex-1825) .................................................................................. 63
`E.
`Enger (Ex-1850)...................................................................................... 65
`F.
`X. KONTOS RENDERS CLAIMS 25-26, 28-31, 34-37, and 39 OBVIOUS IN
`VIEW OF ADAMS AND/OR THE Knowledge of a POSITA. ....................67
`XI. KONTOS RENDERS CLAIM 27 OBVIOUS IN VIEW OF ADAMS,
`KATAISHI, AND/OR THE KNOWLEDGE OF A POSITA. .....................104
`XII. KONTOS RENDERS CLAIM 27 OBVIOUS IN VIEW OF ADAMS,
`ENGER, AND/OR THE KNOWLEDGE OF A POSITA. ..........................108
`XIII. KONTOS RENDERS CLAIMS 32 AND 33 OBVIOUS IN VIEW OF
`ADAMS, TAKAHASHI, AND/OR THE KNOWLEDGE OF A POSITA. 111
`XIV. KONTOS RENDERS CLAIM 38 OBVIOUS IN VIEW OF ADAMS,
`BERG, AND/OR THE KNOWLEDGE OF A POSITA. ............................. 114
`XV. CONCLUSION ............................................................................................ 118
`
`
`
`
`
`
`
`
`
`
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`Page 3
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`TABLE OF EXHIBITS
`
`
`Exhibit Description
`1801 U.S. Patent No. RE45,380 (“the ’380 patent”)
`1802
`File history for U.S. Patent No. 8,292,850
`1803
`File history for U.S. Patent No. RE45,380
`1804 Assignment record of the ’380 patent from the USPTO assignment
`database
`1805 Declaration of Doctor Stephen JD Brecker, M.D.
`1806
`Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1807 U.S. Patent No. 7,736,355 (“Itou”)
`1808 U.S. Patent No. 7,604,614 (“Ressemann”)
`1809 U.S. Patent No. 5,439,445 (“Kontos”)
`1810
`New Method to Increase a Backup Support of a 6 French Guiding
`Coronary Catheter, Catheterization and Cardiovascular Interventions
`63: 452-456 (2004) (“Takahashi”)
`Excerpt of prosecution history of U.S. Patent No. 8,048,032
`(Application 11/416,629) (Amendment and Response, April 6, 2009)
`Joint Claim Construction Statement in QXMedical, LLC v. Vascular
`Solutions, Inc., D. Minn., No. 17-cv-01969 (January 10, 2018), D.I.
`36; D.I. 36-1.
`1813 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1814 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).
`1816 US Patent Publication 2003/0233117 (“Adams ’117”)
`1817 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1811
`
`1812
`
`1815
`
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`

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`1821
`
`1824
`
`Exhibit Description
`1818 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1819 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1820 Mehan, Coronary Angioplasty through 4 French Diagnostic
`Catheters, Catheterization and Cardiovascular Interventions 30:22-26
`(1993) (“Mehan”)
`Excerpt of prosecution history for application 11/232,876 (Office
`Action, 6/20/09)
`Cordis, Instructions for Use, CYPHER™ (April 2003)
`1822
`1823 Medtronic, Summary of Safety and Effectiveness Data, Driver™
`Coronary Stent System (October 1, 2003)
`Boston Scientific, Summary of Safety and Effectiveness Data,
`TAXUS™ Express2™ Drug-Eluting Coronary Stent System (March
`4, 2004)
`1825 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1826 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1827 U.S. Patent No. RE45,776 (“Root”)
`1828
`Baim, Randomized Trial of a Distal Embolic Protection Device
`During Percutaneous Intervention of Saphenous Vein Aorto-
`Coronary Bypass Grafts, Circulation 105:1485-1490 (2002) (“Baim”)
`Limbruno, Mechanical Prevention of Distal Embolization During
`Primary Angioplasty, Circulation 108:171-176 (2003) (“Limbruno”)
`1830 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1831
`Schöbel, Percutaneous Coronary Interventions Using a New 5
`French Guiding Catheter: Results of a Prospective Study,
`Catheterization & Cardiovascular Interventions 53:308-314 (2001)
`(“Schöbel”)
`The sliding rail system (monorail): description of a new technique for
`intravascular instrumentation and its application to coronary
`angioplasty, Z. Kardio. 76:Supp. 6, 119-142 (1987) (“Bonzel”)
`1833 U.S. Publication Application No. 2004/0236215 (Mihara)
`
`1829
`
`1832
`
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`1841
`
`1840
`
`Exhibit Description
`1834 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1835 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1836 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1837 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1838 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:149-140 (1996)
`1839 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)).
`1842 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1843
`Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1844 U.S. Patent No. 5,961,510 (“Fugoso”)
`1845 U.S. Patent No. 6,199,262 (“Martin”)
`1846 U.S. Patent No. 6,042,578 (“Dinh”)
`1847 WO 97/37713 (“Truckai”)
`1848
`Terumo Heartrail II product literature
`1849 Medtronic Launcher product literature
`1850 U.S. Patent No. 5,980,486 (“Enger”)
`1851 U.S. Patent No. 5,911,715 (“Berg”)
`1852 U.S. Patent No. 5,545,149 (“Brin”)
`1853 U.S. Patent No. 5,720,300 (“Fagan”)
`
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`Exhibit Description
`1854 U.S. Patent No. 5,140,323 (“Shockey”)
`1855
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1856 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1857 U.S. Patent No. 5,445,625 (“Voda”)
`1858 U.S. Patent No. 6,595,952 (“Forsberg”)
`1859 U.S. Patent No. 6,860,876 (“Chen”)
`1860 U.S. Patent No. 6,638,268 (“Niazi”)
`1861 U.S. Patent No. 5,690,613 (“Verbeek”)
`1862
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1863 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1864 QXMédical, LLC’s Opening Claim Construction
`Memorandum QXMedical, LLC v. Vascular Solutions, Inc., D. Minn.,
`No. 17-cv-01969 (March 14, 2018), D.I. 56
`1865 U.S. Patent No. 4,000,739 (“Stevens”)
`1866
`EP 0 881 921 B1 (“Lee”)
`1867 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1868 Defendants’ Memorandum in Opposition to Plaintiff’s Summary
`Judgment Motion and in Support of Defendants’ Summary Judgment
`Motion, QXMedical, LLC v. Vascular Solutions LLC et al., 17-cv-
`01969-PJS-TNL (D. Minn 2019)
`Excerpt of prosecution history for application 14/195,435 (Office
`Action, 10/06/15)
`1870 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”)
`
`1869
`
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`1875
`
`Exhibit Description
`1871
`Feldman, Coronary Angioplasty Using New 6 French Guiding
`Catheters, Catheterization and Cardiovascular Diagnosis 23:93-99
`(1991) (“Feldman”)
`1872 U.S. Patent No. 5,704,926 (“Sutton”)
`1873
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1874 Yokoyama, Feasibility and safety of thrombectomy with TVAC
`aspiration catheter system for patients with acute myocardial
`infarction, Heart Vessels (2006) 21:1–7 (“Yokoyama”)
`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.
`1876 U.S. Patent No. 5,860,963 (“Azam”)
`1877
`10/16/2019 Deposition of Peter Keith in Vascular Solutions, LLC. v.
`Medtronic, Inc., D. Minn., No. 19-cv-01760
`Sylvia Hall-Ellis’s Librarian Declaration
`Complaint in Vascular Solutions, LLC. v. Medtronic, Inc., D. Minn.,
`No. 19-cv-01760 (October 11, 2019), D.I. 1-14.
`1880 U.S. Patent No. 5,061,273 (“Yock”)
`1881
`Intentionally Left Blank
`1882 Declaration of Peter Keith in Support of Plaintiffs’ Motion for
`Preliminary Injunction, Vascular Solutions LLC et al. v. Medtronic,
`Inc., 19:cv-01760-PJS-TNL (July 14, 2019)
`Joint Fed. R. C. P. 26(f) Report [Excerpt], Vascular Solutions LLC et
`al. v. Medtronic, Inc., 19:cv-01760-PJS-TNL
`Plaintiffs’ Objections and Responses to Interrogatories [Excerpt],
`Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-01760-PJS-
`TNL
`
`1878
`1879
`
`1883
`
`1884
`
`
`
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`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. RE45,380.
`
`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.
`
`RE45,380, and will be requesting that the PTAB cancel all challenged claims of
`
`this patent 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
`I am an interventional cardiologist who has been the Chief of
`4.
`
`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 1806.
`
`7.
`
`I have been a practicing, interventional cardiologist for over 23 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
`I am informed by counsel that RE45,380 (“the ’380 patent”) is one
`13.
`
`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; and RE47,379. 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 ’380 patent (Ex-1801), and the file
`
`histories of the ’380 patent and its predecessor, U.S. Pat. No. 8,292,850 (“the ’850
`
`patent”) (Ex-1802, Ex-1803). I have also reviewed U.S. Pat. No. 5,439,445
`
`(“Kontos”) (Ex-1809); U.S. Patent Application Publication 2004/0010280
`
`(“Adams”) (Ex-1835); New Method to Increase a Backup Support of a 6 French
`
`Guiding Coronary Catheter, Catheterization and Cardiovascular Interventions 63:
`
`452-456 (2004) (“Takahashi”) (Ex-1810); and U.S. Patent No. 5,911,715 (“Berg”)
`
`(Ex-1851); and the other material referred to herein.
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`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 ’380 patent at the time of the alleged invention.
`
`16.
`
`I understand the ’380 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 May of 2006. My opinions
`
`reflect how a person of ordinary skill in the art would have understood the ’380
`
`patent, prior art to the ’380 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 25-39 of the ’380 patent.
`
`18.
`
`It is my opinion that claims 25-39 of the ’380 patent are invalid as
`
`obvious.
`
`IV. LEGAL STANDARDS
`I am not a lawyer and have been informed by counsel of the legal
`19.
`
`standards set forth herein.
`
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`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.
`
`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
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`understand that secondary considerations may be used to rebut a prima facie
`
`showing of obviousness.1
`
`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. For the ’380 patent, a person of ordinary skill in the art (“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
`
`1 To date, I am unaware of any objective indicia of non-obviousness. 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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`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-1842, ¶¶ 18-19. 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 ’380 patent relates to interventional
`
`cardiology procedures using catheters. See Ex-1801, Abstract, 1:30-35. Catheters
`
`are tube-like members inserted into the body for diagnostic or therapeutic medical
`
`reasons. The hollow portion of a catheter is referred to as a “lumen.2” In particular,
`
`the technology of the ’380 patent relates to catheters inserted into the coronary
`
`arteries from the aorta. In the context of the ’380 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
`
`2 Lumen is also used to refer to the blood-filled interior of the artery.
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`blood flow often relied on drug therapy and coronary artery bypass grafts
`
`(“CABG”). Ex-1814 at 2. A drawback of CABG is that it requires open-heart
`
`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
`
`30.
`
`In general, percutaneous coronary interventional procedures refer to
`
`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.
`
`
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`32. Catheter-based technology, such as the technology described in the
`
`’380 patent, is used by interventional cardiologists to help remedy these conditions
`
`and restore unrestricted blood flow.
`
`33. To better describe the ’380 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
`
`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-1815, 601-636. None of these techniques “cure” coronary artery
`
`disease.
`
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`artery) or the wrist (radial artery), to gain access to the patient’s vasculature.
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`Through the hollow needle, a guidewire is introduced into the patient’s artery. The
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`needle is then removed and an introducer sheath is inserted over the guidewire and
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`into the artery. Once the introducer sheath is placed, a guidewire and guide catheter
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`are introduced into the artery and pushed through the artery until the guide catheter
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`is positioned in the ascending aorta.
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`35. The guide catheter includes a hemostatic valve coupled to the
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`proximal hub of the guide catheter. This valve may also be referred to as a
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`“hemostasis valve” or a “Tuohy-Borst valve.” Hemostatic valves—that have been
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`used since at least the 1970s (Ex-1865)—enable the introduction of a variety of
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`devices into the patient’s artery, including guidewires, catheters and stents.
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`Hemostatic valves are the standard of care in PCI procedures. Ex-1815 at 557. No
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`responsible physician would perform a PCI procedure without a hemostatic valve
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`because it is the valve that (i) prevents blood loss and (ii) prevents air from
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`entering the body (causing an air embolism). Ex-1835, [0060].
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`B. HISTORY OF PERCUTANEOUS CORONARY
`INTERVENTIONAL PROCEDURES
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`36.
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`Initially, coronary catheters were widely used for diagnostic purposes.
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`But, in the 1980s, physicians had begun to employ catheter-based interventional
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`procedures, which, collectively, can be referred to as PCI procedures.
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`37. The initial PCI procedures involved the use of a balloon catheter to
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`widen coronary arteries, using a procedure called “balloon angioplasty,” or
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`“percutaneous transluminal coronary angioplasty (“PTCA”). Ex-1815, 547. As
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`depicted below, physicians could insert a balloon catheter into the body through
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`either the wrist/arm or groin of a patient, and then— using fluoroscopic
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`screening—guide the balloon catheter to the target lesion. Ex-1814 at 3. Upon
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`reaching the target lesion, a physician could then inflate the balloon catheter. Id.
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`The inflation of the balloon increases blood flow by displacing the plaque and
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`increasing the size of the vessel’s lumen. Ex-1815 at 562.
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`
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`
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`38. While balloon angioplasty has its use, it also has particular risks
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`associated with it. These risks include the potential for abrupt vessel closure
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`(which used to require emergency bypass in about 1% of patients) and the risk of
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`restenosis (e.g., the recurrence of stenosis after the balloon angioplasty procedure
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`is completed). Ex-1815 at 637. About 30% of patients who experience restenosis
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`will need repeat balloon angioplasty. Id. In addition, when the plaque is displaced,
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`there is the risk that it will be dislodged and embolize distally. It is also recognized
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`that thrombus can form in these circumstances and itself embolize elsewhere in the
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`patient’s vasculature.
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`39. Because of the risks associated with balloon angioplasty, physicians
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`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-1838, 1330-1334. 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. Ex-
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`1815, 637.
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`C. BASIC TOOLS OF PERCUTANEOUS CORONARY
`INTERVENTION
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`41. While coronary angioplasty systems were initially developed over 40
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`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). Ex-1815 at 548. While I discuss these components in
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`more detail below, I also provide a modified image from U.S. Pat. No. 5,720,3004
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`to Fagan et al. (“Fagan”) (see below) as guidance. See Ex-1853.
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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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`Ex-1853 (Fagan), Fig. 1, color and labels 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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`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-
`1815 at 548-549.)
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`44. The figure below illustrates a typical guide catheter configuration
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`available in the late 1990s and early 2000s. See Ex- 1851, Fig. 5.
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`
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`Ex-1851, Fig. 5.
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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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`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.
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`46. The basic unit of measure used throughout the industry to measure the
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`size of a catheter is “French size.”5 In the early 1980s, the 9 French inner-diameter
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`5 French size is commonly abbreviated as “Fr.” One French equals 1/3 mm. Ex-
`1862 at 545.
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`catheters predominated. Ex-1815 at 549. In the 1990s 7 French or 8 French guiding
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`catheters were typically used. Ex-1870 at 131; Ex-1871 at 94 (describing 8 French
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`as conventional). By the 2000s, the inner diameter of guide catheters typically
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`ranged from 5 French to 8 French. See Ex-1810 at 453-454; Ex-1815 at 548-549.
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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-1810 at 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.)
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`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
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`catheters and stents in order to reduce trauma to the vasculature and to permit use
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`of radial (wrist) access sites. See Ex-1815 at 549.
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`49. Guide catheters have varying rigidity along their length. Id. The distal
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`tip (generally the last 2 mm) of a guide catheter was flexible and soft, to minimize
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`the risk of vessel trauma as the catheter was inserted to a desired location. Id. The
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`catheter’s rigidity increased moving proximally, from its distal tip.
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`50. More specifically, it was known in the art to design guide catheters
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`along their length with regions of varying flexural moduli in order to optimize the
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`ability to push and position a guide catheter, navigate complex anatomy such as the
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`aortic arch, yet impart no trauma to the vasculature. I understand that flexural
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`modulus is a material property that expresses the tendency of a material to resist
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`bending. Ex-1842, ¶ 56
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`51. By the 1990s, it was known to design guide catheters such that the
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`distal tip was the most flexible portion and increase the rigidity of the catheter in a
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`proximal direction from the distal tip. For example, U.S. Pat. No. 5,911,715
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`(“Berg”), teaches that an atraumatic soft tip of a guide catheter should have a
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`fle