IPR2020-01454
`U.S. Patent No. 9,125,739
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`MEDTRONIC COREVALVE LLC,
`Petitioner,
`v.
`COLIBRI HEART VALVE LLC,
`Patent Owner.
`____________
`Case IPR2020-01454
`U.S. Patent No. 9,125,739
`____________
`DECLARATION OF DR. WILLIAM J. DRASLER IN SUPPORT OF PETITION FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 9,125,739
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`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 1 of 130
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`I.
`II. QUALIFICATIONS ........................................................................................ 4
`A.
`Summary ............................................................................................... 4
`B.
`Education ............................................................................................... 5
`C. Work History ......................................................................................... 6
`1.
`2015-Present – William Drasler Consulting: .............................. 6
`2.
`2008-2015 – InterValve, Inc.: ..................................................... 6
`3.
`2001-2008 – Boston Scientific, Inc.: .......................................... 7
`4.
`1999-2001 – Lake Region Manufacturing, Inc.: ........................ 7
`5.
`1986-1996 – Possis Medical, Inc.: .............................................. 7
`6.
`1983-1986 – SciMed, Inc.: .......................................................... 8
`III. LEGAL UNDERSTANDING ......................................................................... 8
`A. My Understanding of Claim Construction ............................................ 8
`B. My Understanding of Obviousness ..................................................... 11
`C.
`Level of Ordinary Skill in the Art ....................................................... 15
`IV. BACKGROUND OF THE TECHNOLOGY ................................................ 17
`V.
`THE ’739 PRIORITY DATE ........................................................................ 20
`VI. THE ’739 PATENT ....................................................................................... 20
`A. Overview of the ’739 Patent ................................................................ 20
`B.
`Prosecution History of the ’739 Patent ............................................... 28
`VII. CLAIM CONSTRUCTION .......................................................................... 30
`A.
`“trumpet-like” ...................................................................................... 31
`B.
`“valve means” ...................................................................................... 31
`C.
`“controlled release mechanism” .......................................................... 33
`VIII. GROUNDS OF UNPATENTABILITY ........................................................ 35
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`
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`i
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`IPR2020-01454
`U.S. Patent No. 9,125,739
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`A. Ground 1: Garrison Renders Obvious Claims 1-5 .............................. 36
`1.
`Overview of U.S. 6,425,916 (“Garrison”) ................................ 37
`2.
`Invalidity of Claims 1-5 over Garrison ..................................... 51
`(a) Element [1.pre] .................................................................................... 51
`(b) Element [1.1] ....................................................................................... 51
`(c) Element [1.2] ....................................................................................... 53
`(d) Element [1.3] ....................................................................................... 56
`(e) Element [1.4] ....................................................................................... 59
`(f) Element [1.5] ....................................................................................... 61
`(g) Element [1.6] ....................................................................................... 64
`(h) Claim 2 ................................................................................................ 66
`(i) Claim 3 ................................................................................................ 66
`(j) Claim 4 ................................................................................................ 67
`(k) Claim 5 ................................................................................................ 68
`B. Ground 2: Garrison in view of Leonhardt Renders Obvious
`Claims 1-5 ........................................................................................... 69
`1.
`Overview of U.S. 5,957,949 (“Leonhardt”) .............................. 69
`2. Motivation to Apply Leonhardt’s Teachings in
`Implementing Garrison ............................................................. 73
`Invalidity of Claims 1-5 Over Garrison in view of
`Leonhardt .................................................................................. 76
`(a) Element [1.2] ....................................................................................... 76
`(b) Elements [1.3] and [1.6] ...................................................................... 77
`C. Grounds 3-4: Garrison in View of Nguyen (Ground 3) or
`Leonhardt and Nguyen (Ground 4) Renders Obvious Claims 1-
`5. .......................................................................................................... 79
`D. Ground 5: Andersen in view of Limon and Gabbay Renders
`Obvious Claims 1-3, 5. ........................................................................ 82
`1.
`Overview of U.S. 5,840,081 (“Andersen”) ............................... 83
`2.
`Overview of U.S. 6,077,295 (“Limon”) ................................... 85
`3. Motivation to Apply Limon’s Teachings in Implementing
`Andersen ................................................................................... 88
`Overview of U.S. 7,025,780 (“Gabbay”) and Motivation
`to Apply to Andersen in view of Limon ................................... 92
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`3.
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`4.
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`ii
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`IPR2020-01454
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`169. Specifically, ............................................................................... 95
`5.
`Invalidity of Claims 1-3, 5 Over Andersen in view of
`Limon and Gabbay .................................................................... 97
`(a) Element [1.pre] .................................................................................... 97
`(b) Element [1.1] ....................................................................................... 98
`(c) Element [1.2] ....................................................................................... 99
`(d) Element [1.3] .....................................................................................101
`(e) Element [1.4] .....................................................................................105
`(f) Element [1.5] .....................................................................................106
`(g) Element [1.6] .....................................................................................110
`(h) Claim 2 ..............................................................................................111
`(i) Claim 3 ..............................................................................................112
`(j) Claim 5 ..............................................................................................113
`E.
`Grounds 6-7: Andersen in view of Limon, and WO00/15147
`(“Phelps”) (Ground 6) or Limon, Phelps, and Nguyen (Ground
`7) Renders Obvious Claims 1-3, 5. ...................................................114
`Grounds 8-10: Claim 4 Is Rendered Obvious by Andersen in
`View of Limon, Garrison and Gabbay (Ground 8) or Andersen
`in View of Limon, Garrison and Phelps (Ground 9), or
`Andersen in view of Limon, Garrison, Phelps, and Nguyen
`(Ground 10). ......................................................................................118
`IX. SECONDARY CONSIDERATIONS .........................................................120
`X.
`CONCLUSION ............................................................................................120
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`
`F.
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`
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`iii
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`I.
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`Introduction
`1.
`I have been retained by Medtronic CoreValve LLC to provide my
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`opinions on certain issues related to U.S. Patent No. 9,125,739 (the “’739 patent” or
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`“Paniagua”) in connection with the above-captioned inter partes review (IPR)
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`proceeding. In particular, I have been asked to provide my insights, analysis, and
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`opinions regarding whether claims 1-5 of the ’739 patent are obvious over the prior
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`art references identified below.
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`2.
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`I understand the ’739 patent is titled “Percutaneous replacement heart
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`valve and a delivery and implantation system,” names as inventors David Paniagua
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`and R. David Fish, and is currently owned by Colibri Heart Valve LLC. I have
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`considered the ’739 patent. I understand that the ’739 patent has been provided as
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`Ex. 1001.
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`3.
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`I understand that the file history of the ’739 patent has been provided
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`as Ex. 1003. I have considered this file history.
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`4.
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`I understand that the ’739 patent claims priority to application Nos.
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`13/675,665, 10/887,688, and 10/037,266. I understand that file histories for these
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`applications have been provided as Exs. 1017, 1016, and 1018 respectively. I have
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`considered these file histories.
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`Edwards Lifesciences Corporation, et al. Exhibit 1002, p. 5 of 130
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`IPR2020-01454
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`5.
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`I understand that the ’739 patent claims a priority date of January 4,
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`
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`2002, the filing date of application No. 10/037,266. I have been asked to assume
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`that priority date for purposes of rendering my opinions in this declaration. I have
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`not been asked to opine on whether the claims of the ’739 are entitled to this priority
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`date, and do not provide any opinion on that subject.
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`6.
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`I have considered the prior art cited in my declaration, including:
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`U.S. Patent No. 6,425,916 to Garrison, titled “Methods And Devices For
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`Implanting Cardiac Valves,” filed February 10, 1999, and issued July 30, 2002. I
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`understand this patent has been provided as Ex. 1005.
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`U.S. Patent No. 5,957,949 to Leonhardt, titled “Percutaneous Placement
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`Valve Stent,” filed May 1, 1997 and issued September 28, 1999. I understand this
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`patent has been provided as Ex. 1006.
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`U.S. Patent No. 6,077,295 to Limon, titled “Self-Expanding Stent Delivery
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`System,” filed July 15, 1996, and issued June 20, 2000. I understand this patent has
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`been provided as Ex. 1008.
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`U.S. Patent No. 7,025,780 to Gabbay, titled “Valvular Prosthesis,” claiming
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`priority to September 12, 2000, and issued April 11, 2006. I understand this patent
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`has been provided as Ex. 1009.
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`2
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`International Patent No. WO 00/15147 to Phelps, titled “TMR Shunt,” with
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`an international filing date of September 10, 1999, and a publication date of March
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`23, 2000. I understand this patent has been provided as Ex. 1010.
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`International Patent No. WO 98/29057 to Letac, titled “Valve Prosthesis
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`For Implantation In Body Channels,” with an international filing date of December
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`31, 1997, and a publication date of July 9, 1998. I understand this patent has been
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`provided as Ex. 1012.
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`U.S. Patent No. 5,840,081 to Andersen, titled “System and Method for
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`Implanting Cardiac Devices,” filed February 19, 1997 and issued November 24,
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`1998. I understand this patent has been provided as Ex. 1013.
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`U.S. Patent No. 4,056,854 to Boretos, titled “Aortic Heart Valve Catheter,”
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`and issued Nov. 8, 1977. I understand this patent has been provided as Ex. 1004.
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`U.S. Patent No. 5,961,549 to Nguyen, titled “Multi-Leaflet Bioprosthetic
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`Heart Valve,” filed April 3, 1997, and issued October 5, 1999. I understand this
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`patent to have been provided as Ex. 1020.
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`U.S. Patent No. 5,713,950 to Cox, titled “Method of Replacing Heart valves
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`Using Flexible Tubes,” filed June 2, 1995, and issued February 3, 1998. I understand
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`this patent to have been provided as Ex. 1021.
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`3
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`IPR2020-01454
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`7.
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`I am being compensated by my agency, WIT Legal, LLC at my
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`standard hourly consulting rate for my time on this matter. I understand Medtronic
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`is compensating my agency for my time at my standard hourly rate plus hourly fees
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`charged by WIT Legal, LLC, with reimbursement for actual expenses. Neither my
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`compensation nor WIT Legal, LLC’s compensation is dependent on the outcome of
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`this proceeding.
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`II. Qualifications
`A.
`Summary
`8.
`A copy of my curriculum vitae is attached as Appendix B to this
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`Declaration. It provides a more comprehensive description of my experience for the
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`last thirty-odd years.
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`9.
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`In forming my opinions, I relied on the documents cited in this
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`declaration and the documents identified in the attached Appendix A. These
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`documents comprise patents, file histories, printed publications, and other related
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`documents. As discussed below, each document is a type that experts in my field
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`would have reasonably relied upon when forming their opinions. Further, experts in
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`my field would have had access to each document either through the applicable
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`patent offices and/or well-known libraries, conferences, or publications in the field.
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`My opinions are also based upon my personal and professional experience.
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`4
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`10.
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`I have worked in the medical device industry for over 30 years
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`primarily in the area of interventional cardiology devices, but also with extensive
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`experience in cardiovascular surgical devices. My background in anatomy and
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`physiology combined with my knowledge of fluid mechanics has provided me with
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`an ability to design medical devices that combine engineering principles with
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`healing mechanisms found in the human body. I currently have over 90 issued
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`patents and over 120 patent applications. I am also an author on over a dozen
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`publications. I have also provided expert witness and expert consulting services,
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`including in connection with percutaneous transluminal coronary angioplasty.
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`B.
`11.
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`Education
`I earned a Bachelor's Degree in Chemical Engineering from the
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`University of Illinois in 1972 and a Master's Degree in Chemical Engineering from
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`the University of Wisconsin, Madison in 1973. My Master's Degree work
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`investigated fluid mechanical improvements to evaporative cooling systems.
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`12.
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`I received a PhD in Biomedical Engineering from the University of
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`Minnesota in 1983. My study of blood rheology as it relates to Sickle Cell Anemia
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`has provided me with a working knowledge of hemodynamics and thrombosis.
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`5
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`C. Work History
`1.
`2015-Present – William Drasler Consulting:
`I am currently retired although I have remained active in my pursuit of
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`13.
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`improvements to medical devices. For example, I continue to attend the
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`Transcatheter Cardiac Therapeutics (TCT) meetings, which is one of the lead
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`conferences in this field. I currently have identified and patented a transcatheter
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`Mitral Valve system (Two Component Mitral Valve). Other recently patented
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`inventions include a Compression Stent to treat hypertension and a Cardiac Access
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`Catheter to provide access to the mitral valve annulus from the superior vena cava.
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`I am also a consultant for an outside medical device company that is manufacturing
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`and selling a large bore closure device for closing the femoral artery access site
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`following Transcatheter Aortic Valve Replacement (“TAVR”) procedures.
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`2.
`2008-2015 – InterValve, Inc.:
`I was a founder and served as Chief Technology Officer (“CTO”) for
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`14.
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`InterValve, Inc., a start-up company that invented, developed, and manufactured an
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`hour-glass shaped balloon for valvuloplasty prior to performing a TAVR procedure.
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`During that time, I was closely familiar with TAVR devices being used in the
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`industry and the potential benefits of using the InterValve balloon along with
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`specific TAVR devices.
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`6
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`3.
`2001-2008 – Boston Scientific, Inc.:
`I served as VP of Applied Research for Boston Scientific, Inc. (“BSCI”)
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`15.
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`working to identify primarily new Interventional Cardiology devices for the
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`company. The Applied Research group identified a proprietary TAVR device
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`system that included a unique valve leaflet design. Other device concepts identified
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`by the Applied Research group include a vascular closure device for closing a large
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`bore closure site following a TAVR procedure, a percutaneous Venous Valve, a
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`cryoablation catheter for treating atrial fibrillation, and pacemaker seeds that would
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`help address heart failure.
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`4.
`1999-2001 – Lake Region Manufacturing, Inc.:
`I served as VP of Engineering for all Medical Devices at Lake Region
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`16.
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`Manufacturing, Inc., an OEM manufacturer of medical devices worldwide. My area
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`of responsibility included a variety of guidewires, distal protection device, vena cava
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`filter, and pacemaker leads.
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`5.
`1986-1996 – Possis Medical, Inc.:
`I served as VP of R&D for a start-up company called Possis Medical,
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`17.
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`Inc. that developed a coronary vascular graft. While working at Possis Medical, the
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`Possis team and I invented and developed a proprietary Angiojet catheter to ablate
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`and remove thrombus from coronary and peripheral arteries. The Angiojet system
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`7
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`proceeded into sales and eventually Possis Medical was purchased by Boston
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`Scientific, Inc
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`6.
`1983-1986 – SciMed, Inc.:
`I was a Manager of angioplasty catheters at SciMed, Inc. at a time when
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`18.
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`angioplasty was first getting started. Several technical problems plagued SciMed in
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`the early start-up phase including balloon breakage and poor bonds, which I helped
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`to address through plasma treatment of the balloons.
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`19. My CV provides further details on my qualifications to render an expert
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`opinion.
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`III. Legal Understanding
`A. My Understanding of Claim Construction
`20.
`I have been informed that patent claims are construed from the
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`viewpoint of a person of ordinary skill in the art of the patent at the time of the
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`invention. I have been informed that patent claims generally should be interpreted
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`consistent with their plain and ordinary meaning as understood by a person of
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`ordinary skill in the art in the relevant time period (i.e., at the time of the purported
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`invention, or the so called “effective filing date” of the patent application), after
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`reviewing the patent claim language, the specification and the prosecution history
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`(i.e., the intrinsic record).
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`8
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`21.
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`I have further been informed that a person of ordinary skill in the art
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`
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`must read the claim terms in the context of the claim itself, as well as in the context
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`of the entire patent specification. I understand that in the specification and
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`prosecution history, the patentee may specifically define a claim term in a way that
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`differs from the plain and ordinary meaning. I understand that the prosecution
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`history of the patent is a record of the proceedings before the U.S. Patent and
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`Trademark Office, and may contain explicit representations or definitions made
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`during prosecution that affect the scope of the patent claims. I understand that an
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`applicant may, during the course of prosecuting the patent application, limit the
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`scope of the claims to overcome prior art or to overcome an examiner’s rejection, by
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`clearly and unambiguously arguing to overcome or distinguish a prior art reference,
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`or to clearly and unambiguously disavow claim coverage.
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`22.
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`I understand that there is a “means-plus-function” type of claim
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`interpretation that may be argued to apply to certain terms, pursuant to 35 U.S.C.
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`§112(6). For these terms, if the term is determined to be a “means-plus-function”
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`term under §112(6), I understand that there must be a corresponding structure
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`disclosed in the specification in a way that a person of ordinary skill in the art would
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`understand what structure would perform the claimed function. I understand the
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`disclosure may be implicit in the specification if it would have been clear to a person
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`of ordinary skill in the art what structure corresponds to the claimed function. I
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`understand that when a claim is expressed as a means for performing a specified
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`function without the recital of structure, a claim is construed to cover the
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`corresponding structure described in the specification and equivalents thereof. I
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`understand that one factor that will support a conclusion that a prior art element is
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`an equivalent is if the prior art element performs the identical function specified in
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`the claim in substantially the same way, and produces substantially the same result
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`as the corresponding element disclosed in the specification.
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`23.
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`In interpreting the meaning of the claim language, I understand that a
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`person of ordinary skill in the art may also consider “extrinsic” evidence, including
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`expert testimony, inventor testimony, dictionaries, technical treatises, other patents,
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`and scholarly publications. I understand this evidence is considered to ensure that a
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`claim is construed in a way that is consistent with the understanding of those of
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`ordinary skill in the art at the time of the claimed invention. For example, this can
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`be useful for a technical term whose meaning may differ from its ordinary English
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`meaning. I understand that extrinsic evidence may not be relied on if it contradicts
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`or varies the meaning of claim language provided by the intrinsic evidence,
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`particularly if the applicant has explicitly defined a term in the intrinsic record.
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`B. My Understanding of Obviousness
`24.
`I understand that a claim may be invalid if the subject matter described
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`by the claim as a whole would have been obvious to a hypothetical person of
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`ordinary skill in the art in view of a prior art reference or in view of a combination
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`of references at the time the claimed invention was made. Therefore, I understand
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`that obviousness is determined from the perspective of a hypothetical person of
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`ordinary skill in the art and that the asserted claims of the patent should be read from
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`the point of view of such a person at the time the claimed invention was made. I
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`further understand that a hypothetical person of ordinary skill in the art is assumed
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`to know and to have all relevant prior art in the field of endeavor covered by the
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`patent in suit.
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`25.
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`I have been informed that there are two criteria for determining whether
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`prior art is analogous and thus can be considered prior art: (1) whether the art is from
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`the same field of endeavor, regardless of the problem addressed, and (2) if the
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`reference is not within the field of the patentee’s endeavor, whether the reference
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`still is reasonably pertinent to the particular problem with which the patentee is
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`involved. I have also been informed that the field of endeavor of a patent is not
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`limited to the specific point of novelty, the narrowest possible conception of the field,
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`or the particular focus within a given field. I have also been informed that a reference
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`is reasonably pertinent if, even though it may be in a different field from that of the
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`patentee’s endeavor, it is one which, because of the matter with which it deals,
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`logically would have commended itself to a patentee’s attention in considering his
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`problem.
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`26.
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`I have also been advised that an analysis of whether a claimed invention
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`would have been obvious should be considered in light of the scope and content of
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`the prior art, the differences (if any) between the prior art and the claimed invention,
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`and the level of ordinary skill in the pertinent art involved. I understand as well that
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`a prior art reference should be viewed as a whole.
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`27.
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`I have also been advised that in considering whether a claimed
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`invention could be obvious over a combination of prior art references, I may assess
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`whether there are apparent reasons to combine known elements in the prior art in the
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`manner claimed in view of interrelated teachings of multiple prior art references, the
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`effects of demands known to the design community or present in the market place,
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`and/or the background knowledge possessed by a person having ordinary skill in the
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`art. I understand that other principles may be relied on in evaluating whether a
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`claimed invention would have been obvious, and that these principles include the
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`following:
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` A combination of familiar elements according to known methods is likely
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`to be obvious when it does no more than yield predictable results;
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` When a device or technology is available in one field of endeavor, design
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`incentives and other market forces can prompt variations of it, either in
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`the same field or in a different one, so that if a person of ordinary skill
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`can implement a predictable variation, the variation is likely obvious;
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` If a technique has been used to improve one device, and a person of
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`ordinary skill in the art would recognize that it would improve similar
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`devices in the same way, using the technique is obvious unless its actual
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`application is beyond his or her skill;
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` An explicit or implicit teaching, suggestion, or motivation to combine
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`two prior art references to form the claimed combination may
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`demonstrate obviousness, but proof of obviousness does not depend on or
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`require showing a teaching, suggestion, or motivation to combine;
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` Market demand, rather than scientific literature, can drive design trends
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`and may show obviousness;
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` In determining whether the subject matter of a patent claim would have
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`been obvious, neither the particular motivation nor the avowed purpose
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`of the named inventor controls whether the claim is obvious;
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` One of the ways in which a patent’s subject can be proved obvious is by
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`noting that there existed at the time of invention a known problem for
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`which there was an obvious solution encompassed by the patent’s claims;
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` Any need or problem known in the field of endeavor at the time of
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`invention and addressed by the patent can provide a reason for combining
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`the elements in the manner claimed;
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` “Common sense” teaches that familiar items may have obvious uses
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`beyond their primary purposes, and in many cases a person of ordinary
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`skill will be able to fit the teachings of multiple patents together like
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`pieces of a puzzle;
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` A person of ordinary skill in the art is also a person of ordinary creativity,
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`and is not an automaton;
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` A patent claim can be proved obvious by showing that the claimed
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`combination of elements was “obvious to try,” particularly when there is
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`a design need or market pressure to solve a problem and there are a finite
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`number of identified, predictable solutions such that a person of ordinary
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`skill in the art would have had good reason to pursue the known options
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`within his or her technical grasp; and
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` One should be cautious of using hindsight in evaluating whether a
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`claimed invention would have been obvious.
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`28.
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`I further understand that, in making a determination as to whether the
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`claimed invention would have been obvious to a person of ordinary skill, the Board
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`may consider certain objective factors if they are present, such as: commercial
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`success of products practicing the claimed invention; long-felt but unsolved need;
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`teaching away; unexpected results; copying; and praise by others in the field. These
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`factors are generally referred to as “secondary considerations” or “objective indicia”
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`of nonobviousness. I understand, however, that for such objective evidence to be
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`relevant to the obviousness of a claim, there must be a causal relationship (called a
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`“nexus”) between the claim and the evidence and that this nexus must be based on a
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`novel element of the claim rather than something in the prior art. I also understand
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`that even when they are present, secondary considerations may be unable to
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`overcome primary evidence of obviousness (such as motivation to combine with
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`predictable results) that is sufficiently strong.
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`29.
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`I have been asked to consider the validity of the Claims. I understand
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`that for inter partes reviews, invalidity must be shown under a preponderance of the
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`evidence standard. I have concluded that each of the Claims is rendered obvious by
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`the prior art based on the references described below and as explained herein.
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`C. Level of Ordinary Skill in the Art
`30.
`In rendering the opinions set forth in this declaration, I was asked to
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`consider the patent claims and the prior art through the eyes of a person of ordinary
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`skill in the art at the time of the alleged invention. I understand that the factors
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`considered in determining the ordinary level of skill in a field of art include the level
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`of education and experience of persons working in the field; the types of problems
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`encountered in the field, the teachings of the prior art, and the sophistication of the
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`technology at the time of the alleged invention. I understand that a person of ordinary
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`skill in the art is not a specific real individual, but rather is a hypothetical individual
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`having the qualities reflected by the factors above. I understand that a person of
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`ordinary skill in the art would also have knowledge from the teachings of the prior
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`art, including the art cited below.
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`31. Upon consideration of these factors, in my opinion, on or before
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`January 4, 2002, a person of ordinary skill in the art relating to the technology of
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`the ’739 patent would have had a minimum of either a medical degree and
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`experience working as an interventional cardiologist or a Bachelor’s degree in
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`bioengineering or mechanical engineering (or a related field) and approximately two
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`years of professional experience in the field of percutaneously, transluminally
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`implantable cardiac prosthetic devices. Additional graduate education could
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`substitute for professional experience, or significant experience in the field could
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`substitute for formal education.
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`32. Well before January 4, 2002, my level of skill in the art was at least that
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`of a person of ordinary skill. I am qualified to opine concerning what a person of
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`ordinary skill in the art would have known and understood at the time of the ’739
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`patent’s purported invention. My analysis and conclusions herein are from the
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`perspective of a person of ordinary skill in the art as of January 4, 2002.
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`33.
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`I