throbber
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`In the Inter Partes Review of:
`U.S. Patent No. 6,482,228
`
`Filed: Nov. 14, 2000
`
`Issued: Nov. 19, 2002
`
`Inventor(s): Troy R. Norred
`
`Assignee: None
`
`Trial Numbers: IPR2014-00110
`IPR2014-00111
`
`Attorney Docket Nos.: 058888/0000014
`058888/0000018
`
`Title: Percutaneous Aortic Valve Replacement
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
`DECLARATION OF ALEXANDER J. HILL, PhD
`
`I, Alexander J. Hill, PhD, declare as follows:
`
`1.
`
`I have been asked by my employer, Medtronic Inc. to provide my
`
`opinions in this declaration in connection with the inter partes review of U.S.
`
`Patent No. 6,482,228 (the “’228 patent”).
`
`2.
`
`I have personal knowledge of the following facts and would and could
`
`testify competently regarding the following statements if called as a witness.
`
`3.
`
`In forming my opinions, I understand that the claims should be
`
`interpreted as they would be understood by a person of ordinary skill in the art of
`
`the subject matter of the patents. I also understand that claims are ordinarily
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`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
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`construed based on the plain meaning of the terms used in the claims, and also with
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`reference to the specification, the patent drawings, and the prosecution history. In
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`addition, I understand that although the specification should be consulted to aid in
`
`the process of interpreting the claims, the specific examples disclosed in the
`
`specification generally do not limit the scope of the claims. Finally, I also
`
`understand that claim interpretation may be aided by reference to other sources of
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`information, such as dictionaries, textbooks, and literature or other patents in
`
`related fields, in order to determine the ordinary meanings of terms used in the
`
`claims. I further understand that for the purposes of this inter partes review, the
`
`claims should be given their broadest reasonable interpretation when viewed in
`
`light of the specification. In addition, I understand that claims expressed as a
`
`“means” for performing a recited function should be interpreted as covering the
`
`corresponding structure material or acts disclosed in the specification and
`
`equivalents thereof.
`
` BACKGROUND
`I am 39 years of age and was born in Edina, MN.
`
` WORK EXPERIENCE
`I am currently employed by Medtronic, Inc.
`
`4.
`
`5.
`
`6. My place of employment is 8200 Coral Sea Street NE, Mounds View,
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`MN 55112.
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`2
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
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`7. My position at Medtronic, Inc. is Sr. Research Manager.
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`I am recognized as a Technical Fellow at Medtronic, Inc.
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`I currently serve as Chair of the Medtronic Science & Technology
`
`8.
`
`9.
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`Conference.
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`10.
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`I am currently a Clinical Assistant Professor, Department of Surgery,
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`at the University of Minnesota Medical School.
`
`11.
`
`In my current role at Medtronic, Inc. as a Senior Research Manager in
`
`the Cardiac and Vascular Group, Coronary and Structural Heart, I manage a group
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`that conducts research focused on percutaneous, minimally invasive, and surgical
`
`heart valve replacement and repair including anatomical characterization, device
`
`research and design, image guided therapy development, and animal model
`
`development for testing of novel products. I also lead technical projects in
`
`Structural Heart product development. Over the past eight years, I have personally
`
`designed and tested numerous percutaneous heart valves, and have implanted heart
`
`valves into both live and isolated hearts.
`
`12. From August, 2012 through May, 2014, I served as a Research
`
`Manager at Medtronic, Inc. in the Cardiac and Vascular Group, Structural Heart,
`
`where I managed a group that conducts research focused on percutaneous,
`
`minimally invasive, and surgical heart valve replacement and repair including
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`anatomical characterization, device research and design, image guided therapy
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`3
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
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`development, and animal model development for testing of novel products. I also
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`lead technical projects in Structural Heart product development.
`
`13. From July, 2008 through August, 2012, I served as a Principal
`
`Scientist at Medtronic, Inc., CardioVascular division, where I conducted research
`
`focused on percutaneous, minimally invasive, and surgical heart valve replacement
`
`and repair including anatomical characterization, device research and design,
`
`image guided therapy development, and animal model development for testing of
`
`novel products.
`
`14. From May, 2007 through July, 2008, I served as a Senior Scientist at
`
`Medtronic, Inc., CardioVascular division, where I conducted research focused on
`
`percutaneous, minimally invasive, and surgical heart valve replacement and repair
`
`including device research and design, image guided therapy development, and
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`animal model development for testing of novel products.
`
`15. From May, 2006 through May, 2007, I served as a Senior Scientist at
`
`Medtronic, Inc., Cardiac Surgery division, where I conducted research focused on
`
`percutaneous, minimally invasive, and surgical heart valve replacement and repair
`
`including device research and design, image guided therapy development, and
`
`animal model development for testing of novel products.
`
`16. From January, 2006 through May, 2006, I served as a Senior Scientist
`
`at Medtronic, Inc., Vascular division. Where I conducted research focused on
`
`4
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
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`percutaneous, minimally invasive, and surgical heart valve replacement and repair
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`including device research and design, image guided therapy development, and
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`animal model development for testing of novel products.
`
`17. From December, 2003 through January of 2006, I served as a Senior
`
`Scientist at Medtronic, Inc., Cardiac Rhythm Management Physiological Research
`
`Laboratory division, where I conducted research focused on advanced cardiac MRI
`
`applications and analysis, comparative cardiac anatomy, improved histopathology
`
`techniques, and animal model development.
`
`18. From September, 2003 through December, 2003, I served as a
`
`Scientist at Medtronic, Inc. Cardiac Rhythm Management Physiological Research
`
`Laboratory, where I conducted research focused on comparative cardiac anatomy,
`
`improved histopathology techniques, and animal model development.
`
`19. From April, 2000 through September, 2003, I served as a Biomedical
`
`Engineering Intern at Medtronic, Inc. Cardiac Rhythm Management Therapy
`
`Delivery, where I was involved in research of pacemaker mechanics using
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`numerical modeling and product testing utilizing The Visible HeartTM
`
`Methodologies.
`
`20. From September, 1999 through May, 2000, I participated in the New
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`Product Design and Business Development class, with University of Minnesota
`
`and Medtronic, Inc. This was a year-long class offering industry experience in
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`5
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
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`which I designed and developed an interactive CD-ROM utilizing images from the
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`Visible Heart Project for use as an educational and sales tool. The CD-ROM was
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`targeted at cardiologists, cardiac surgeons, electrophysiologists, and resident
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`medical school students in these areas.
`
` EDUCATION
`I received my PhD in Biomedical Engineering in 2004 from
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`21.
`
`University of Minnesota, and also received a Minor in Cellular and Integrative
`
`Physiology.
`
`22.
`
`I received my MS in Biomedical Engineering in 2000 from University
`
`of Minnesota, and was awarded a graduate fellowship.
`
`23.
`
`I received a minor in Mechanical Engineering in 2000 from
`
`University of Minnesota.
`
`24.
`
`I received a BA in Biology in 1997 (Magna Cum Laude) from
`
`Gustavus Adolphus College, St. Peter, MN.
`
`25. From April, 2002 to September, 2003, I was a Graduate Research
`
`Assistant in the Department of Surgery, University of Minnesota, where I worked
`
`in a cardiovascular research laboratory studying mammalian cardiac anatomy,
`
`physiology, and pathology.
`
`26. From January, 1999 to April, 2002, I was a Graduate Research
`
`Assistant in the Department of Anesthesiology, University of Minnesota, where I
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`6
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`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
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`worked in a cardiovascular research laboratory studying mammalian cardiac
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`anatomy, physiology, and pathology, and also worked in a human subjects lab
`
`studying the effects of the usage of the LTX3000TM Lumbar Rehabilitation
`
`System on scoliosis.
`
` EDUCATIONAL ACTIVITIES
`27. From 2002 to present, I have served as an Instructor in the Advanced
`
`Cardiac Anatomy & Physiology course at the University of Minnesota.
`
`28. From 2008 to present, I have served as an Instructor in advanced
`
`cardiac anatomy didactic and dissection course for electrophysiology and
`
`cardiology fellows.
`
`29. From 2010 to present, I have served as an Instructor in Advanced
`
`Cardiac Anatomy & Physiology courses within Medtronic.
`
` MATERIALS REVIEWED
`In preparing this declaration, I have reviewed U.S. Patent No.
`
`30.
`
`6,482,228 patent to Norred (“the ‘228 patent”), U.S. Patent No. 6,454,799 to
`
`Schreck (“Schreck”), U.S. Patent No. 4,030,142 to Wolfe (“Wolfe”), U.S. Patent
`
`No. 6,440,164 to DiMatteo (“DiMatteo”), U.S. Patent No. 5, 957,949 to Leonhardt
`
`et al. (“Leonhardt”), the Declaration of Timothy Titus Catchings, M.D., dated July
`
`14, 2014 in this proceeding, and the deposition testimony of Dr. Catchings dated
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`October 7, 2014 in this proceeding.
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` LEVEL OF SKILL IN THE ART
`31. Based on my experience with the design, development, and
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`manufacture of percutaneous heart valves, the ordinary person in that field would
`
`typically have a bachelor’s level degree in mechanical or biomedical engineering
`
`(or gained such knowledge by equivalent experience), and have had direct
`
`experience developing heart valves.
`
`32.
`
`I understand that the relevant time frame for the person of ordinary
`
`skill in the art is around the time the ‘228 Patent was filed, i.e., Nov. 14, 2000.
`
`Thus, any comments I make regarding the knowledge of the ordinary person are in
`
`reference to that timeframe.
`
` THE NATIVE AORTA AND AORTIC VALVE
`33. The aortic root is a portion of the aorta that includes the aortic valve,
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`the sinuses of Valsalva and the origins of the main coronary arteries. The aortic
`
`annulus is part of the aortic root. The aortic root is formed by an aortic wall that
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`surrounds the aortic channel. Figure 1 in the attached article entitled Anatomy of
`
`the aortic root: implications for valve-sparing surgery”, by Efstratios I. Charitos,
`
`Hans-Hinrich Sievers, Department of Cardiac and Thoracic Vascular Surgery,
`
`University of Lübeck, Lübeck, Germany, published in the Annals of
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`Cardiothoracic Surgery, Vol. 2, No 1., pages 53-56 (January 2013). illustrates this
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`configuration . The ascending aorta is the portion of the aorta that commences at
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`8
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`the aortic valve and extends upwardly to the aortic arch. The aorta is a flexible or
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`pliable structure that stretches to handle changes in blood flow and pressure.
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`34. Placement and positioning of prosthetic aortic valves within the aorta
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`is typically within the discretion of the physician. Placement is based on, among
`
`other things, anatomical aspects of a particular patient. It well known by those
`
`skilled in the art that aortic valves can be placed at different positions within the
`
`aorta, such as the lower portions of the aortic root or more upwardly in the
`
`ascending aorta.
`
`35. The commissures in a native aortic valve constitute the superior
`
`attachment point where the leaflets of two adjacent aortic valve leaflets come
`
`together. The commissures contain no musculature, and are passive structures that
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`simply attach the valve leaflets to the aortic wall. The commissures do not cause
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`any movement of the leaflets. Rather, the function of the leaflets occurs purely in
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`response to pressures in the aorta and the left ventricle. The commissures, if
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`provided, in a prosthetic tissue valve would typically perform the same function
`
`when placed in a human aorta, even though such prosthetic tissue valves do not
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`contain any living tissue.
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`36. The “coaptation surface” referred to in Dr. Catchings declaration are
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`the regions at which the three aortic valve leaflets come together. Like the
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`commissures, the coaptation surface contains no musculature, and are passive
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`regions on each leaflet that form part of the seal between the leaflets.
`
` THE ‘228 PATENT
`A. Claim Interpretation for Claims 16 and 20 Generally
`37.
`I have reviewed claims 16 and 20 and note that the introduction of
`
`each claim (which I understand to be the “preamble”) calls for “An aortic valve for
`
`controlling/regulating a blood flow through an aortic channel . . . .” Thus, it is my
`
`understanding that these claims are directed to an aortic valve disclosed in the ‘228
`
`patent.
`
`B. Ring Member
`38. As I would understand it, the term “ring member” as used in claims 16
`
`and 20 means a ring shaped component of the valve that has an outer
`
`circumference that can be seated about an aortic wall surrounding an aortic
`
`channel.
`
`39. While Dr. Catchings’ declaration seems to state that the term “ring
`
`member” as used in claims 16 and 20 means a ring made of “pliable”
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`biocompatible material, I do not agree for several reasons.
`
`40. First, I do not find any express requirement of pliability in the claims,
`
`and I see nothing in the claims that would otherwise impose that requirement.
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`41. Second, the stated reason for Dr. Catchings’ belief that a “ring
`
`member” as described in the ‘228 patent claims must be pliable is flawed for
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`several reasons. For example, while pliability could be a factor relating to a sealing
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`function, heart valve seals are often created with relatively rigid ring structures.
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`This can be easily achieved because the aorta itself is pliable and will conform to
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`the shape of a relatively rigid heart valve ring member. In addition, besides
`
`pliability, several other factors relate to a sealing function with the aorta, such as
`
`the surface area of the ring and amount of contact with the aorta.
`
`42. Third, the term “pliable” is a relative term, and it alone does not
`
`inform one of ordinary skill in the art as to its meaning. If anything, the addition of
`
`the term “pliable” makes the claim less understandable because the range of
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`material hardness that can be used is vast.
`
`C. Claim 16 – Means for Mounting
`43. With respect to claim 16, I understand that this claim calls for “means
`
`for mounting said first open end of said membrane about said ring aperture.” I
`
`believe that this language pertains to the examples of Figures 10 through 13 and
`
`Figures 14 through 17, but not to Figures 1-9 or Figures 18-19, as explained below.
`
`44. As I read it, claim 16 states that the “means” for mounting to performs
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`two functions:
`
`i) mounting a first open end of a membrane about a ring aperture with
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`a second open end of the membrane displaced therefrom; and
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`ii) moving the membrane second end between a first open position to
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`allow a blood flow therethrough and a second closed position to preclude a
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`blood flow therethrough.
`
`45.
`
`I have been informed that this “means for mounting” language must
`
`be interpreted by law to include the structure disclosed in the ‘228 specification
`
`that performs these functions, and equivalents.
`
`46.
`
`I have reviewed the ‘228 specification in detail and conclude that this
`
`language relating to the mounting means is found only in the examples shown and
`
`described in Figures 10 through 13, and Figures 14 through 17, but not in Figures
`
`1-9 or Figures 18-19.
`
`47. Specifically, with respect to Figures 1-9, the valve disclosed therein is
`
`an umbrella valve. That valve is mounted on a central connecting rod and does not
`
`have a membrane mounted about a ring aperture. Thus, I find no structure that
`
`would perform the claimed function of “mounting said first open end of said
`
`membrane about said ring aperture” (requirement (i) above). That would not be
`
`possible, because there is no ring disclosed in Figures 1-9.
`
`48. With respect to Figures 10 through 13, the ‘228 patent describes that
`
`fingers 68 mount the cone shaped membrane 75 along its length. The bottom end
`
`of the fingers 68 are hingedly attached to the ring 72, by the ring 72 passing
`
`through the base 74 of each finger 68, as I understand from column 4, lines 55 to
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`61. As I see in Figures 10-13, the fingers 68 mount the two open ends of the
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`membrane so that they are displaced from one another. The first open end is
`
`mounted by the fingers 68 to the ring, and the second open end is mounted by the
`
`fingers 68 so as to be displaced upwardly from the first end. Movement of the
`
`fingers 68 moves the membrane second end (upper end) between the open and
`
`closed positions. As a result, I believe the fingers 68 perform the two functions
`
`attributable to the “means for mounting,” i.e., (i) mounting a first open end of a
`
`membrane about a ring aperture with a second open end of the membrane
`
`displaced therefrom, and (ii) moving the membrane second end between a first
`
`open position to allow a blood flow therethrough and a second closed position to
`
`preclude a blood flow therethrough.
`
`49. With respect to Figures 14 through 17, the ‘228 patent describes that
`
`arms 84 mount the cone shaped membrane 92 along its length. The bottom end of
`
`the arms 84 are hingedly attached to the ring 86 of base 88, as I understand from
`
`column 5, lines 35 to 55. As I see in Figures 14 through 17, the arms 84 mount the
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`two open ends of the membrane so that they are displaced from one another. The
`
`first open end is mounted by the arms 84 to the ring 86, and the second open end
`
`(upper end) is mounted by the arms 84 to be displaced upwardly from the first end.
`
`Movement of the arms 84 moves the membrane second end between the open and
`
`closed positions. As a result, the arms perform the two functions attributable to the
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`“means for mounting,” i.e., (i) mounting a first open end of a membrane about a
`
`ring aperture with a second open end of the membrane displaced therefrom, and
`
`(ii) moving the membrane second end between a first open position to allow a
`
`blood flow therethrough and a second closed position to preclude a blood flow
`
`therethrough.
`
`50. With respect to Figures 18-19, the ‘228 specification discloses the use
`
`of tissue rather than a membrane. One of ordinary skill in the art reading the ‘228
`
`patent would not understand the term membrane to include tissue, particularly
`
`when those terms are used so dissimilarly in the same document.
`
`51. Figures 18-19 also contain no disclosure of any structure that
`
`performs the two functions of the “means for mounting.” The ‘228 patent, at most,
`
`states only that the valve is “retained in a base ring.” However, I find no disclosure
`
`of any structure that mounts a first open end of a membrane (or tissue for that
`
`matter), with a second open end displaced therefrom. I see no structure that mounts
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`two ends of a membrane in displaced relationship.
`
`52.
`
`I also do not see any structure whatsoever disclosed in connection
`
`with Figures 18 and 19 that would perform the function of “moving the membrane
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`second end” between open and closed positions as required by claim 16.
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`D. Claim 20 – Means for Maintaining
`53. As I read it, claim 20 calls for “means for maintaining said ring
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`member in said seated position about the aortic wall.” I believe that this language
`
`refers to the connecting rods 104 illustrated in Figure 18, and does not include any
`
`portions of a stent.
`
`54. This belief stems from several factors. First, I read claim 20 as a
`
`whole to be directed to “An aortic valve for controlling a blood flow through an
`
`aortic channel upon placement therein.” One of ordinary skill in the art reading the
`
`‘228 patent would not understand the described aortic valve to include the stent
`
`system as one of its components. Specifically, the ‘228 patent specification
`
`indicates in several instances that the stent 28 is not part of the valve, but is a
`
`separate structure connected to the valve. For example, the ‘228 patent explains
`
`that the “[t]he valve is connected to the stent system by serially connected rods.”
`
`Col. 1, lines 63-64.
`
`55. Second, the ‘228 patent describes the connecting rods 104 as the
`
`vehicle for “maintaining the ring member in the seated position about the aortic
`
`wall.” I see this in column 6, lines 4-7, stating that the valve is “anchored along the
`
`root of the aortic valve with connecting rods 104 which are connected to the
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`ascending aortic stents 28 shown in Fig. 4. Valve 100 is placed such that rods are
`
`positioned between the right and left coronary ostia tangentially along the sinus of
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`the valsalva.” This language, as well as Figures 18 and 19 and the accompanying
`
`description, indicates that the rods 104 are to be considered part of the valve, and
`
`attributes the positioning and anchoring of the valve and its ring to the rods 104.
`
`The rods 104 are described as being connected to the stents 28, but not part of the
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`stent.
`
` PRIOR ART
`
`A. DiMatteo
`56. DiMatteo discloses a sealing arrangement very much like that
`
`described in the ‘228 patent. DiMatteo discloses that a valve leaf frame defines a
`
`valve leaf aperture with a scaffold. DiMatteo states that it’s “invention seals each
`
`valve leaf aperture to prevent fluid flow therethrough. The material used to seal
`
`each valve leaf aperture is sufficiently thin and pliable so as to permit radially-
`
`collapsing the leaf valve portion for delivery by catheter to a location within a
`
`body lumen.” This is essentially the same teaching as the ‘228 patent as I read it.
`
`57. Dr. Catchings’ declaration refers to tissue ingrowth in DiMatteo as
`
`somehow being required for the valve therein to seal. There is no such teaching or
`
`disclosure in DiMatteo. DiMatteo only states that in one example, tissue ingrowth
`
`may assimilate the valve into the body. However, there is no mention of this
`
`playing a role in the sealing function.
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`58. Dr. Catchings’ declaration also states that the pressures and blood
`
`flow in the aorta are too great for tissue growth to occur. This is incorrect. In fact,
`
`tissue ingrowth almost always occurs in the aorta with any device or foreign object
`
`that is in contact with the aorta. This is the natural response of the human anatomy
`
`and physiology of the body.
`
`59. Dr. Catchings’ deposition testimony further presents various
`
`hypothetical drawings (Exhibits 2132-2134) of the DiMatteo valve, and also
`
`presents testimony of what “could happen” with various manners of implantation.
`
`None of this testimony or drawings find a basis or foundation in DiMatteo. I find
`
`nothing credible about this testimony, as one of ordinary skill in the art would not
`
`design or implant the DiMatteo valve in the manner suggested or hypothesized by
`
`Dr. Catchings’ testimony. That is, one of ordinary skill in the art in valve design
`
`would ensure that the leaflets of the DiMatteo valve would have sufficient
`
`flexibility and/or overlap to ensure proper alignment and orientation to seal and
`
`prevent regurgitation. Also, it must be noted that even perfectly functioning
`
`prosthetic aortic valves do not fully prevent regurgitation, nor is this required.
`
`Specifically, some back flow will occur with each valve closing. It is well known
`
`that a prosthetic valve that provides less than complete fluid integrity between
`
`adjacent valve leafs will still achieve desired performance parameters.
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`60.
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`I have also reviewed the drawings presented by Dr. Catching that
`
`allegedly represent the DiMatteo valve implanted in a native aorta. I believe these
`
`drawings are incorrect representations of the placement of a prosthetic valve in
`
`relation to the native aorta. The valve would normally be placed further upwards in
`
`the aorta. The drawings are also drawn out of proportion in relation to what is
`
`shown in the DiMatteo patent, and in relation to how these components would look
`
`as implanted in the native aorta. The illustrated distortions of the valve ring and
`
`leaflets would not occur with a proper design.
`
`B. Wolfe
`61. Wolfe discloses a prosthetic aortic valve that includes a ring member
`
`and a plurality of cuspids that are described throughout the patent as being
`
`“flexible” to enable movement thereof between open a closed positions. These
`
`cuspids comprise a valve “membrane” as that term would be understood by one of
`
`ordinary skill in the art.
`
`62. Wolfe further discloses a valve seat assembly 14 and annular ring 56
`
`that constitute a ring member that seats about the aortic wall. The outer surface of
`
`the valve seat assembly 14 is made of a Dacron mesh cloth that will seat about the
`
`aortic wall surrounding the aortic channel.
`
`63.
`
`I have also reviewed Dr. Catchings’ testimony, where he states that
`
`the Wolfe invention relates to mitral valves, and not to aortic valves. This is
`
`18
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1026 - Page 18
`
`

`

`incorrect, as Wolfe expressly explains that the disclosed valve can be used to
`
`replace aortic valves. It is also well known that the valve of the type shown and
`
`described with respect to Wolfe could be used as an aortic valve.
`
`64.
`
`I am also of the opinion that the Wolfe valve would properly seal and
`
`seat in a native aorta, and that I further believe that minimal regurgitation would
`
`occur with Wolfe’s operation
`
`C.
`Schreck
`65. Schreck discloses an aortic tissue valve that includes a ring member
`
`106/110 and “means for maintaining” 146/148 the ring member 106/110 in a
`
`seated position about the aortic wall. The Schreck patent states that the ring
`
`member material 110 is maintained in direct contact with the tissue of the aortic
`
`wall. The means for maintaining (or posts 146, 148) provide lateral support for the
`
`ring member 110. This lateral support is provided by the posts being connected by
`
`connectors 170 to the ring member 106/110 as seen in Fig. 12.
`
`66. Dr. Catchings’ declaration seems to indicate that the Schreck valve
`
`does not extend into the aorta. This is incorrect. Schreck’s disclosure expressly
`
`states that the valve is delivered to the host heart valve annulus. The host heart
`
`valve annulus is within the aortic root and forms part of the aortic wall. The
`
`Schreck valve is shown in the aorta, with portions of the valve extending into the
`
`19
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1026 - Page 19
`
`

`

`ascending aorta. Dr. Catchings’ deposition testimony is consistent with this (“there
`
`is not a lot of this that goes supravalvular”).
`
`67. Dr. Catchings’ testimony also seems to indicate that not a large
`
`portion of the valve goes supravalvular (meaning above the valve, i.e., into the
`
`ascending aorta), and as a result the device would undergo substantial stress. I
`
`disagree, as many heart valves used in practice today do not extend deeply into the
`
`ascending aorta have been found to work perfectly well.
`
`68.
`
` Placement and positioning of aortic valves, such as that shown in
`
`Schreck, is typically within the discretion of the physician. Placement is based on,
`
`among other things, anatomical aspects of a particular patient. It well known by
`
`those skilled in the art that aortic valves can be placed at different positions within
`
`the aorta, and most typically within the aortic root. The aortic valve of Schreck
`
`would be adapted for placement in different locations within the aortic root, against
`
`the aortic wall.
`
`69. Dr. Catchings’ deposition testimony speaks about the cantilevering
`
`effect of the posts 146/148 and has the belief that such effect will cause
`
`regurgitation. I disagree. Schreck discloses that posts 146/148 flex “slightly.” I
`
`understand this slight flexing as part of the intended valve operation and would not
`
`create regurgitation or peeling away of the ring from the aortic wall. In fact,
`
`20
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1026 - Page 20
`
`

`

`flexing of such rods is a well-known intended design attribute that is used to
`
`reduce stress on the valve leaflets.
`
`70. Dr. Catchings’ deposition testimony further presents various
`
`hypothetical drawings (Exhibits 2129 to 2131) of the Schreck valve, and also
`
`presents testimony of what “could happen” with various manners of implantation.
`
`None of this testimony or drawings find a basis or foundation in Schreck. I find
`
`nothing credible about this testimony, as one of ordinary skill in the art would not
`
`design or implant the Schreck valve in the manner suggested or hypothesized by
`
`Dr. Catchings’ testimony. That is, one of ordinary skill in the art in valve design
`
`would ensure that the leaflets of the Schreck valve would have sufficient flexibility
`
`and/or overlap to ensure proper alignment and orientation to seal and prevent
`
`regurgitation. Even perfectly functioning prosthetic aortic valves do not fully
`
`prevent regurgitation. Specifically, some back flow could occur with each valve
`
`closing. It is well known that a prosthetic valve that provides less than complete
`
`fluid integrity between adjacent valve leaflets would still achieve desired
`
`performance parameters.
`
`71.
`
`I have also reviewed the drawings presented by Dr. Catchings that
`
`allegedly represent the Schreck valve implanted in a native aorta. I believe these
`
`drawings are incorrect representations of the placement of a prosthetic valve in
`
`relation to the native aorta. The valve would normally be placed further upwards in
`
`21
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1026 - Page 21
`
`

`

`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1026 - Page 22
`
`

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