Declaration previously submitted in conjunction with
`Medtronic, Inc. and Medtronic Vascular, Inc.’s Petition
`for Inter Partes Review in IPR2020-00137, et seq.
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`Medtronic Ex. 1917
`Medtronic v. Teleflex
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`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MEDTRONIC, INC. AND MEDTRONIC VASCULAR, INC.,
`Petitioners,
`v.
`TELEFLEX INNOVATIONS S.À.R.L.,
`Patent Owner.
`
`Case No.: IPR2020-00137
`U.S. Patent No: RE47,379
`
`DECLARATION OF STEPHEN JON DAVID BRECKER,
`MD, FRCP, FESC, FACC
`
`Page 1
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`

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`IPR2020-00137
`Patent RE47,379
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`INTRODUCTION ......................................................................................... 1
`II. QUALIFICATIONS ...................................................................................... 1
`III.
`SUMMARY OF OPINIONS ......................................................................... 3
`IV. LEGAL STANDARDS .................................................................................. 4
`A.
`Claim Construction................................................................................ 4
`B.
`Anticipation ........................................................................................... 5
`C.
`Obviousness ........................................................................................... 5
`PERSON OF ORDINARY SKILL IN THE ART ....................................... 7
`V.
`VI. OVERVIEW OF THE TECHNOLOGY ..................................................... 7
`A.
`History of Percutaneous Coronary Interventional Procedures .............. 8
`B.
`Basic tools of percutaneous coronary intervention ............................. 13
`PCI: Guide catheter ..................................................................14
`1.
`PCI: Guidewire .........................................................................20
`2.
`PCI: Therapeutic devices ..........................................................21
`3.
`PCI: Additional backup support ...............................................24
`4.
`PCI: Mother and child catheter systems ...................................25
`5.
`PCI: Over-the-wire versus Rapid Exchange .............................30
`6.
`7.
`PCI: Proximal openings on child catheter ...............................35
`PCI: Interventional cardiology in the early 2000s ...................49
`8.
`VII. THE ’379 PATENT ......................................................................................51
`A.
`Claims of the ’379 Patent Considered ................................................. 51
`B.
`File histories of the ’379 and ’850 patents .......................................... 51
`C.
`Summary of the ’379 patent ................................................................ 52
`VIII. CLAIM CONSTRUCTION ........................................................................55
`IX. OVERVIEW OF THE REFERENCES .....................................................59
`A.
`Itou ....................................................................................................... 59
`
`i
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`IPR2020-00137
`Patent RE47,379
`B.
`Ressemann ........................................................................................... 60
`C.
`Bagaoisan ............................................................................................ 62
`D. Kataishi ................................................................................................ 63
`E.
`Enger.................................................................................................... 65
`X. CLAIMS 25-26, 29-40 AND 42-45 OF THE ’379 PATENT ARE
`INVALID AS ANTICIPATED OR OBVIOUS. .........................................66
`A. Ground 1: Itou anticipates claims 25-26, 29-31, 33-40, 42, 43
`and 45 of the ’379 patent. .................................................................... 66
`Ground 2: Itou in view of Ressemann and the common
`knowledge of a POSITA renders claims 26, 38-40 AND 43-45
`obvious. ............................................................................................. 110
`Ground 3: Itou in view of the common knowledge of a POSITA
`renders claim 32 obvious. .................................................................. 127
`D. Ground 4: Itou in view of Kataishi and the common knowledge
`of a POSITA renders claims 44 obvious ........................................... 130
`Ground 5: Itou in view of Enger and the common knowledge of
`a POSITA renders claims 44 obvious ............................................... 133
`
`B.
`
`C.
`
`F.
`
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`
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`IPR2020-00137
`Patent RE47,379
`
`TABLE OF EXHIBITS
`
`
`Exhibit Description
`1001 U.S. Patent No. RE47,379 (“the ’379 patent”)
`1002
`File history for U.S. Patent No. 8,292,850
`1003
`File history for U.S. Patent No. RE47,379
`1004 Assignment record of the ’379 patent from the USPTO assignment
`database
`1005 Declaration of Doctor Stephen JD Brecker, M.D.
`1006
`Curriculum Vitae of Doctor Stephen JD Brecker, M.D.
`1007 U.S. Patent No. 7,736,355 (“Itou”)
`1008 U.S. Patent No. 7,604,612 (“Ressemann”)
`1009 U.S. Patent No. 5,439,445 (“Kontos”)
`1010
`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.
`1013 Markman Order in QXMedical, LLC v. Vascular Solutions, Inc., D.
`Minn., No. 17-cv-01969 (October 30, 2018), D.I. 102
`1014 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).
`1016 US Patent Publication 2003/0233117 (“Adams ’117”)
`1017 U.S. Patent No. 5,902,290 (“Peacock”)
`
`1011
`
`1012
`
`1015
`
`
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`iii
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`IPR2020-00137
`Patent RE47,379
`
`1024
`
`1021
`
`Exhibit Description
`1018 U.S. Patent No. 5,891,056 (“Ramzipoor”)
`1019 U.S. Patent No. 6,398,773 (“Bagaoisan”)
`1020 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)
`1022
`1023 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)
`1025 U.S. Publication Application No. 2005/0015073 (“Kataishi”)
`1026 U.S. Patent No. 5,489,278 (“Abrahamson”)
`1027 U.S. Patent No. RE45,776 (“Root”)
`1028
`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”)
`1030 U.S. Patent No. 5,413,560 (“Solar ’560”)
`1031
`Schöbel, Percutaneous Coronary Interventions Using a New 5
`French Guiding Catheter: Results of a Prospective Study,
`Catheterization & Cardiovascular Interventions 53:308-312 (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, 119-122 (1987) (“Bonzel”)
`1033 U.S. Publication Application No. 2004/0236215 (Mihara)
`iv
`
`1029
`
`1032
`
`
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`Patent RE47,379
`
`1041
`
`1040
`
`Exhibit Description
`1034 U.S. Patent No. 5,527,292 (“Adams ’292”)
`1035 U.S. Publication Application No. 2004/0010280 (“Adams ’280”)
`1036 Williams et al., Percutaneous Coronary Intervention in the Current
`Era Compared with 1985-1986, Circulation (2000) 102:2945-2951.
`1037 Dorros, G., et al., Coronary Angioplasty in Patients with Prior
`Coronary Artery Bypass Surgery, Cardiology Clinics 7(4): 791-803
`(1989)
`1038 Ozaki et al, New Stent Technologies, Progress in Cardiovascular
`Disease 2:129-140 (1996)
`1039 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)).
`1042 Declaration of Dr. Richard A. Hillstead, Ph.D.
`1043
`Curriculum Vitae of Dr. Richard A. Hillstead, Ph.D.
`1044 U.S. Patent No. 5,961,510 (“Fugoso”)
`1045 U.S. Patent No. 6,199,262 (“Martin”)
`1046 U.S. Patent No. 6,042,578 (“Dinh”)
`1047 WO 97/37713 (“Truckai”)
`1048
`Terumo Heartrail II product literature
`1049 Medtronic Launcher product literature
`1050 U.S. Patent No. 5,980,486 (“Enger”)
`1051 U.S. Patent No. 5,911,715 (“Berg”)
`1052 U.S. Patent No. 5,545,149 (“Brin”)
`1053 U.S. Patent No. 5,720,300 (“Fagan”)
`
`
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`v
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`IPR2020-00137
`Patent RE47,379
`
`Exhibit Description
`1054 U.S. Patent No. 5,120,323 (“Shockey”)
`1055
`Sakurada, Improved Performance of a New Thrombus Aspiration
`Catheter: Outcomes From In Vitro Experiments and a
`Case Presentation (“Sakurada”)
`1056 Nordenstrom, New Instruments for Catheterization and
`Angiocardiography (“Nordenstrom”)
`1057 U.S. Patent No. 5,445,625 (“Voda”)
`1058 U.S. Patent No. 6,595,952 (“Forsberg”)
`1059 U.S. Patent No. 6,860,876 (“Chen”)
`1060 U.S. Patent No. 6,638,268 (“Niazi”)
`1061 U.S. Patent No. 5,690,613 (“Verbeek”)
`1062
`lserson, J.-F.-B. Charrière: The Man Behind the “French” Gauge,
`The Journal of Emergency Medicine. Vol. 5 pp 545-548 (1987)
`1063 U.S. Publication Application No. 2003/0195546 (“Solar ’546”)
`1064 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
`1065 U.S. Patent No. 4,000,739 (“Stevens”)
`1066
`EP 0 881 921 B1 (“Lee”)
`1067 U.S. Patent No. 5,451,209 (“Ainsworth”)
`1068 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)
`1070 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”)
`
`1069
`
`
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`vi
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`Page 7
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`IPR2020-00137
`Patent RE47,379
`
`Exhibit Description
`1071
`Feldman, Coronary Angioplasty Using New 6 French Guiding
`Catheters, Catheterization and Cardiovascular Diagnosis 23:93-99
`(1991) (“Feldman”)
`1072 U.S. Patent No. 5,704,926 (“Sutton”)
`1073
`Plaintiffs’ Memorandum in Support of Motion for Preliminary
`Injunction, Vascular Solutions LLC et al. v. Medtronic, Inc., 19:cv-
`01760-PJS-TNL
`1074 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.
`1076 U.S. Patent No. 5,860,963 (“Azam”)
`1077
`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.
`1080 U.S. Patent No. 5,061,273 (“Yock”)
`1081 U.S. RE45,380 (“the ’380 patent”)
`1082 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 12, 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
`
`1075
`
`1078
`1079
`
`1083
`
`1084
`
`
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`IPR2020-00137
`Patent RE47,379
`
`Introduction
`I.
`1. I have been retained by Robins Kaplan LLP on behalf of Medtronic, Inc.
`
`(“Medtronic”) as an independent expert to provide my opinions on the subject
`
`matter recited in U.S. Patent No. RE47,379.
`
`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.
`
`RE47,379, 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
`
`1
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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 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.
`
`2
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`IPR2020-00137
`Patent RE47,379
`III. Summary of Opinions
`
`13. I am informed by counsel that RE47,379 (“the ’379 patent”) is one
`
`patent in a family of patents that is owned by Teleflex, which include U.S. Patent
`
`Nos. 8,048,032; RE45,760; RE45,776; and RE45,380. 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 ’379 patent (Ex-1001), and the file
`
`histories of the ’379 patent and its predecessor, U.S. Pat. No. 8,292, 850 (“the ’850
`
`patent”) (Ex-1002, Ex-1003). I have also reviewed U.S. Pat. No. 7,736,355
`
`(“Itou”) (Ex-1007); U.S. Pat. No. 7,604,612 (“Ressemann”) (Ex-1008); 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 ’379 patent at the time of the alleged invention.
`
`16. I understand the ’379 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
`
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`how a person of ordinary skill in the art would have understood the ’379 patent,
`
`prior art to the ’379 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 26-26, 29-40 and 42-45 of the ’379 patent.
`
`18. It is my opinion that claims 26-26, 29-40 and 42-45 of the ’379 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
`
`20. I understand that patent claims are to be interpreted in light of a
`
`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.
`
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`B. Anticipation
`
`22. I understand that under U.S. Patent Law, 35 U.S.C. §102, a claim is
`
`invalid as anticipated if a single prior art reference discloses each and every
`
`limitation of the claimed invention.
`
`23. I am informed that a reference is anticipatory if it contains the claim
`
`elements in the same order as claimed, regardless of whether the prior art and the
`
`claimed invention are directed to achieving the same purpose.
`
`24. I understand that a prior art reference may anticipate a claim without
`
`expressly disclosing a feature of the claimed invention if that missing feature is
`
`necessarily present, or inherent, in the single anticipating reference.
`
`25. I am informed that inherency requires more than a probability or
`
`possibility that a claimed feature is present in the prior art, but rather that the
`
`feature or characteristic is a necessary part of the prior art. I also am informed that
`
`recognition of the inherency by a POSITA— at the time— is not required.
`
`C. Obviousness
`
`26. I understand that under U.S. Patent Law, 35 U.S.C. §103, a claim is
`
`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.
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`27. 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.
`
`28. 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
`
`29. 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.
`
`30. 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
`
`
`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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`obviousness analysis may take account of the inferences and creative steps that a
`
`person of ordinary skill in the art would employ.
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`V.
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`Person of Ordinary Skill in the Art
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`31. For the ’379 patent, a person of ordinary skill in the art (“POSITA”) at
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`the time of the alleged invention would have had (a) a medical degree, (b)
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`completed a coronary intervention training program, and (c) experience working as
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`an interventional cardiologist. Alternatively, a POSITA would have had (a) an
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`undergraduate degree in engineering, such as mechanical or biomedical
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`engineering; and (b) three years of experience designing medical devices,
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`including catheters or catheter-deployable devices. Ex-1042, ¶¶ 18-19. Extensive
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`experience and technical training might substitute for education, and advanced
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`degrees might substitute for experience. Additionally, a POSITA with a medical
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`degree may have access to a POSITA with an engineering degree, and one with an
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`engineering degree might have access to one with a medical degree.
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`VI. Overview of the Technology
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`32. The technology claimed in the ’379 patent relates to interventional
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`cardiology procedures using catheters. (See Ex-1001, Abstract, 1:43-44.) Catheters
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`are tube-like members inserted into the body for diagnostic or therapeutic medical
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`reasons. The hollow portion of a catheter is often referred to as a “lumen.2” In
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`particular, the technology of the ’379 patent relates to catheters inserted into the
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`coronary arteries from the aorta. In the context of the ’379 patent, a catheter
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`functions as a tool to help a physician treat coronary conditions such as coronary
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`artery disease, in which cardiac blood flow is restricted because of the buildup of
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`arterial plaque.
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`33. In the 1960s, prior to the development of catheter-based intervention,
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`physicians attempting to treat coronary artery disease due to restricted coronary
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`blood flow often relied on drug therapy and coronary artery bypass grafts
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`(“CABG”). Ex-1014 at 2. A drawback of CABG is that it requires open-heart
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`surgery. In order to avoid the risks and complications of open-heart surgery, the
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`medical community searched for less invasive techniques.
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`A. History of Percutaneous Coronary Interventional Procedures
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`34. In general, percutaneous coronary interventional procedures refer to the
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`use of catheter-based technology to treat coronary artery disease, wherein the
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`catheter is introduced into a patient’s vasculature utilizing a sheath placed in a
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`peripheral artery, alleviating the need for open heart surgery.
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`2 Lumen is also used to refer to the blood-filled interior of the artery.
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`35. As depicted below, in patients with coronary artery disease, plaque
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`buildup narrows the arterial lumen, and this narrowing is also referred to as a
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`“stenosis.” If plaque buildup is not alleviated, the coronary artery may become
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`completely blocked. In either instance, blood flow is reduced. Complete
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`obstruction of a blood vessel can lead to a heart attack or stroke.
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`36. Catheter-based technology, such as the technology described in the ’379
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`patent, is used by interventional cardiologists to help remedy these conditions and
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`restore unrestricted blood flow.
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`37. To better describe the ’379 patent’s alleged invention, I briefly describe
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`the advances in interventional cardiology (and in particular the use of catheter-
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`based technology3). It is important to keep in mind that while catheter-based
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`3 While I largely focus on the use of balloon angioplasty and stents to displace plaque
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`in the arteries to alleviate blood flow restrictions, it is worth noting that other,
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`technology has advanced, many of the key foundational components of catheters
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`have undergone little change over the years. For example, components such as
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`guide catheters, guidewires, and angioplasty balloons function in the same or
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`similar ways as they did when catheters were first introduced.
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`38. Catheter-based therapies are less invasive than open-heart surgery
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`because the catheters are introduced into the vasculature percutaneously. The
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`procedure begins with a hollow needle puncture in an artery in the leg (femoral
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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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`39. The guide catheter includes a hemostatic valve coupled to the proximal
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`hub of the guide catheter. This valve may also be referred to as a “hemostasis
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`catheter-based interventional techniques are known that rely on removing plaque
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`from the vessel walls. These include atherectomy, laser ablation, and mechanical
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`thrombectomy. Ex. 1015, 601-636. None of these techniques “cure” coronary artery
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`disease.
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`valve” or a “Tuohy-Borst valve.” Hemostatic valves—which have been used since
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`at least the 1970s (Ex-1065)—enable the introduction of a variety of devices into
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`the patient’s artery, including guidewires, catheters and stents. Hemostatic valves
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`are the standard of care in PCI procedures. Ex-1015 at 557. No responsible
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`physician would perform a PCI procedure without a hemostatic valve because it is
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`the valve that (i) prevents blood loss and (ii) prevents air from entering the body
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`(and possibly causing an air embolism). Ex-1035, ¶ [0060].
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`40. 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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`41. 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-1015, 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-1014 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-1015 at 562.
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`42. 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-1015 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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`43. 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
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`tube. “Stenting” refers to the permanent placement of a stent within an artery. A
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`stent functions to prop open the artery and alleviate the restricted blood flow. In
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`order for a stent to reach the target site, a physician uses a catheter-based system to
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`guide and place the stent at the target site.
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`44. 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-1038, 130-134. This
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`meant that stents could be delivered to deeper locations in the coronary
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`vasculature. By at least 2000, stents were used in greater than 80% of PCI
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`procedures. Ex-1015, 637.
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`B. Basic tools of percutaneous coronary intervention
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`45. 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-1015 at 548. While I discuss these components in
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`more detail below, I also provide