UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`______________________
`
`Cases IPR2014-00110
`Patent 6,482,228
`______________________
`
`DECLARATION OF TROY R. NORRED, M.D.
`
`NORRED EXHIBIT 2093 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`______________________
`
`Cases IPR2014-00110
`Patent 6,482,228
`______________________
`
`DECLARATION OF TROY R. NORRED, M.D.
`
`NORRED EXHIBIT 2093 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
`
`
`I, Troy R. Norred, M.D., declare as follows:
`
`1.
`
`I am a citizen of the United States and a resident of Ada,
`
`Oklahoma. My post office address is P.O. Box 1780, Ada, Oklahoma 74821.
`
`2.
`
`3.
`
`I am married and have four children, ages 16 through 25.
`
`I currently am in private practice in Ada, Oklahoma as a board
`
`certified interventional cardiologist. As part of my practice, I see and treat patients
`
`suffering from cardiovascular illness. As part of the treatment I provide to these
`
`patients, I place vascular stents within the vascular tree of the body, in areas ranging
`
`from the heart to the abdomen and upper and lower extremities as well as cerebral-
`
`vascular vessels. I also place pacemakers and defibrillators into patients requiring
`
`them. I have experience with structural heart disease, including the diagnosis,
`
`management and treatment of valvular and congenital heart disease.
`
`4.
`
`I attended college at East Central Oklahoma from 1986 through
`
`1990, earning a Bachelor of Science in Biology. I attended medical school at the
`
`University of Oklahoma College of Medicine from 1990 through 1995, graduating
`
`with a Doctor of Medicine. I served my internship and then residency in internal
`
`medicine at the University of Oklahoma Health Science Center from 1995 through
`
`1998, my cardiology fellowship at the University of Missouri from 1998 through
`
`August 2001, and my interventional cardiology fellowship at Louisiana State
`
`University New Orleans from August 2001 through August 2002.
`
`NORRED EXHIBIT 2093 - Page 2
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`
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`5.
`
`I am the inventor of the replacement aortic valve described in
`
`United States Patent No. 6,482,228 (the “‘228 patent”) issued on November 19, 2002.
`
`Date of Invention
`
`6.
`
`I completed this invention in the United States no later than
`
`December 21, 1998. On that date, to the best of my artistic abilities, I prepared a
`
`sketch of the prosthetic aortic valve described in the ‘228 Patent and signed the sketch
`
`before a Notary Public to confirm its authenticity. A true and correct copy of the
`
`notarized sketch is filed as Exhibit 2003.
`
`7.
`
`Exhibit 2003 depicts each limitation set forth in claims 16 and 20
`
`of the ‘228 Patent. This is demonstrated as follows (the handwritten notes were part
`
`of the original drawing; the typewritten annotations were added for my declaration):
`
`-3-
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`NORRED EXHIBIT 2093 - Page 3
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`
`
`Claim 16
`
`16. An aortic valve for regulating a
`blood flow through an aortic channel
`surrounded by an aortic wall upon
`placement therein
`
`-4-
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`NORRED EXHIBIT 2093 - Page 4
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`
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`16(a) a ring member
`
`16(a)(1) a circumference adapted to
`seat about an aortic wall
`surrounding an aortic channel
`
`16(a)(2) an aperture for blood flow
`therethrough
`
`-5-
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`NORRED EXHIBIT 2093 - Page 5
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`
`
`16(b)(2) second space-‐apart open
`end[s]
`
`16(b)(1) first [open end]
`
`16(b)(3) made of a
`material resistant to a
`fluid flow therethrough
`
`16(b) a membrane
`
`-6-
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`NORRED EXHIBIT 2093 - Page 6
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`
`
`16(c) means for mounting said first
`open end of said membrane about
`said ring aperture with said second
`open end displaced therefrom
`
`16(c)(1) a first open position to allow
`a blood flow therethrough
`
`16(c)(2) a second closed position to
`preclude a blood flow therethrough
`
`-7-
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`NORRED EXHIBIT 2093 - Page 7
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`
`
`Claim 20
`
`20. An aortic valve for controlling a
`blood flow through an aortic channel
`upon placement therein
`
`-8-
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`NORRED EXHIBIT 2093 - Page 8
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`
`
`20(a)(1) said tissue valve interior
`member responsive to changes of
`conditions within the aorta for
`movement of said opening between
`(i) a first closed position
`20(a)(1) said tissue valve interior
`member responsive to changes of
`conditions within the aorta for
`movement of said opening between
`(ii) a second open position
`20(a)(2) an opening movable
`between open and closed positions
`
`20(a) a tissue valve
`
`20(a)(1) an interior member made of
`a tissue material
`
`-9-
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`NORRED EXHIBIT 2093 - Page 9
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`
`
`20(c) means for maintaining said ring
`member in said seated position
`about the aortic wall
`
`20(b) a ring member surrounding
`said tissue valve, said ring member
`having
`
`20(b)(1) an outer circumference
`adapted to seat said ring member
`about an aortic wall surrounding an
`aortic channel
`
`8.
`
`Exhibit 2003 served as the basis for Figures 4 and 18 of the ‘228
`
`Patent. Figure 4 generally depicts the stent system 28 as deployed in the aortic
`
`channel. Figure 18 depicts in detail how the stent system can be attached to the ring
`
`member 102 through connecting rods 104. Exhibit 2003
`
` combines
`
`these
`
`structures, showing the stent system as deployed in the ascending aorta, attached
`
`through connecting rods to the ring member.
`
`-10-
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`NORRED EXHIBIT 2093 - Page 10
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`
`
`Inventive Process
`
`9.
`
`The idea for an aortic valve that is adapted to be placed
`
`percutaneously came to me during my residency at the University of Oklahoma. I
`
`was treating an elderly patient who had been diagnosed with aortic stenosis. The
`
`patient needed a prosthetic aortic valve.
`
`10.
`
`This was the mid-1990s, and surgical aortic valve replacement was
`
`the state of the art. This patient was not a candidate for surgery, however, because of
`
`his advanced age.
`
`11.
`
`Surgical aortic valve replacement was and is highly traumatic. It
`
`requires that a patient’s heart be stopped and the patient placed on a cardiopulmonary
`
`bypass machine to maintain circulation. The surgeon must dissect through the
`
`superficial layers of skin, the sternum, the mediastinum, the pericardium and the aorta
`
`to extract the native aortic valve and suture in a prosthetic one. The dissected areas
`
`then must be closed and drainage tubes installed to drain out the healing liquefaction
`
`of the body compartments. The operation itself takes 3-4 hours, and the patient must
`
`remain in the hospital for up to a week or more. Common complications of this
`
`surgery include bleeding, stroke, infection, respiratory failure, pulmonary embolism,
`
`dehiscence and death.
`
`12.
`
`At the time, there were no prosthetic aortic valves on the market
`
`that could be placed through non-surgical methods. This left elderly patients like
`
`-11-
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`NORRED EXHIBIT 2093 - Page 11
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`
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`mine, who suffered from aortic stenosis but could not tolerate the trauma of surgery,
`
`with no treatment options.
`
`13.
`
`I saw a need for a new aortic valve that could be used to treat this
`
`patient population.
`
`14.
`
`I conducted extensive research regarding the physiology and
`
`mechanics of the aorta, the native aortic valve, and known prosthetic aortic valves.
`
`15.
`
`I concluded that any new valve should mimic the design of the
`
`native valve. This would enable the new valve to approximate the laminar flow of the
`
`native valve, and avoid the increased turbulence associated with alternative valve
`
`designs such as the ball-in-cage design of the Starr-Edwards valve. This was
`
`important because increased turbulence leads to the destruction of red blood cells and
`
`activation of the coagulation cascade, which in turn, leads to anemia and thrombosis.
`
`This is why patients receiving the Starr-Edwards valve and other, similar valves are
`
`required to endure a life-long regimen of anti-coagulants and surveillance.
`
`16. Mimicking the design of the native valve meant the new valve had
`
`to be flexible. The aorta expands and contracts in coordination with the contractions
`
`of the heart to facilitate the smooth and continual propulsion of blood. The new
`
`valve had to be able to tolerate these expansions and contractions without leaking or
`
`becoming dislodged.
`
`-12-
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`NORRED EXHIBIT 2093 - Page 12
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`
`
`17.
`
`At the same time, because the new valve was intended for a
`
`patient population that could not tolerate surgery, the new valve had to incorporate a
`
`structural component that could anchor it in place without sutures or other means of
`
`surgical fixation.
`
`18.
`
`I knew from my residency that stent technology had advanced to
`
`the point where stents could be used to open passages in virtually any area of the
`
`body.
`
`19. Medical device manufacturers had begun constructing stents from
`
`Nitinol, a metal alloy of nickel and titanium capable of remembering and recovering
`
`its original shape even after severe deformation. These stents could be collapsed for
`
`non-surgical insertion into vascular passages and then, once inserted, could expand to
`
`exert radial force against the passage walls to hold the passages open.
`
`20.
`
`I hypothesized that the radial force exerted by these stents alone
`
`would be sufficient to anchor in place a prosthetic aortic valve, thus eliminating the
`
`need for surgical fixation. I also hypothesized these stents could expand and contract
`
`as the aorta expanded and contracted without becoming dislodged or deformed.
`
`21.
`
`In July 1998, I entered the fellowship program at the University
`
`Hospital of the University of Missouri.
`
`22. During the first year of my cardiology fellowship, I was on duty
`
`five to seven nights per week, from 5:00 a.m. until midnight each day, for an average
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`-13-
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`NORRED EXHIBIT 2093 - Page 13
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`
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`workweek of 110 hours. My duties including seeing cardiac patients in the emergency
`
`room, performing acute intervention procedures and reading echocardiograms and
`
`EKGs.
`
`23.
`
`I received a small salary in the fellowship program, which I used
`
`to support my wife and our children.
`
`24.
`
`I supplemented my fellowship salary by moonlighting as an
`
`emergency room physician at the VA Hospital in Columbia, Missouri from August
`
`1998 until August 2001, and at St. Mary’s Hospital in St. Louis, Missouri from January
`
`1999 through August 2001.
`
`25. My work as an emergency room physician, coupled with my
`
`ongoing fellowship duties, meant that I worked at least 100 hours per week
`
`throughout the course of my fellowship, through August, 2001. This was by necessity
`
`and not by choice. I could not surrender my positions at the VA Hospital or St.
`
`Mary’s because I was my family’s only breadwinner and we needed the additional
`
`income. Further, I needed some of this income to support my continued work on
`
`this invention.
`
`26. My fellowship duties, coupled with my moonlighting work as an
`
`emergency room physician, left me with little time to refine or test my hypotheses for
`
`a new aortic valve design. Nonetheless, I made judicious use of whatever time
`
`became available to keep pressing forward.
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`-14-
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`NORRED EXHIBIT 2093 - Page 14
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`
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`27.
`
`In December 1998, I received time off for winter break. I
`
`traveled home to Oklahoma to see my family. While there, I was able to focus on a
`
`potential design for new valve. I created the sketch filed as Exhibit 2003. Note the
`
`notary seal from the State of Oklahoma.
`
`28.
`
`Because of the nature of my fellowship, I was around
`
`interventional cardiologists every day during this time period. I witnessed firsthand
`
`the therapies they were administering to patients and the types of tools they had
`
`available, such as catheters and stents. As these tools were discarded, I took them
`
`home and deconstructed them to attempt to determine how they might work with a
`
`prosthetic aortic valve.
`
`29.
`
`I ordered a plastic model of the aorta and coronary arteries
`
`through the VA, so I could better visualize and understand how a prosthetic aortic
`
`valve might be placed percutaneously. I explored ways of testing my concepts to
`
`determine whether they were sound.
`
`30.
`
`It may seem obvious now—in 2014—a prosthetic aortic valve can
`
`be held in place by a stent, but it was not obvious in 1999. Stents previously had not
`
`been used in this manner. It was unknown whether a stent could withstand the
`
`pressures in the aorta without dislodging or deforming, or how large the stent would
`
`need to be to properly anchor a prosthetic aortic valve in place. When I discussed the
`
`idea of a percutaneously-placed prosthetic aortic valve with Dr. Richard Davis, an
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`NORRED EXHIBIT 2093 - Page 15
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`
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`Associate Professor of Cardiology at the University of Missouri School of Medicine,
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`the idea was met with great skepticism.
`
`31.
`
`As a proof of concept, for my fellowship project, I proposed to
`
`place an enclosed stent within a porcine aorta, pressurize the tube, and then
`
`experimentally derive the amount of surface area needed to contain particular
`
`amounts of pressure. My goals, as stated in the proposal, were “to prove through
`
`surface adherence alone a stent could seat an aortic valve and withstand arterial
`
`force,” and to “experimentally derive the surface area needed.” A copy of my
`
`proposal is filed as Exhibit 2004.
`
`32.
`
`I submitted my proposal to Dr. Davis on May 26, 1999.
`
`33. Dr. Davis inquired about the cost of the project I proposed. I
`
`made several calls to determine the cost of the raw materials. It took me until early
`
`June 1999 to obtain cost information, and I submitted it to Dr. Davis immediately
`
`thereafter. My notes from these calls are filed as Exhibit 2082.
`
`34.
`
`Approximately a month passed before I heard back from Dr.
`
`Davis. Dr. Davis rejected my proposal. He said, without elaboration, that he did not
`
`like my idea.
`
`35. During roughly this same time period, I became aware that the
`
`Department of Veterinary Medicine at the University of Missouri had received a grant
`
`for a project that involved placing stents in the coronary arteries of pigs. As part of
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`NORRED EXHIBIT 2093 - Page 16
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`
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`the project, there was a need for trained surgeons who could perform pig
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`catheterizations. I volunteered. I thought this would help me learn more about pig
`
`anatomy, with the ultimate goal of using live pigs to test my stent concept. I spent
`
`four hours per week on this project, from summer 1999 through fall 1999. The
`
`project was overseen by Drs. Michael Sturek and H.K. Reddy.
`
`36.
`
`Also during this time period, I explored whether it would be
`
`possible to mathematically model an aortic stent, to determine whether the stent could
`
`withstand the pressures within the aorta and, if so, the amount of surface area
`
`required. I made contact with Dr. Fu-Hung Hsieh, a Professor of Agricultural
`
`Engineering at the University of Missouri. Dr. Hsieh expressed a willingness to help,
`
`but had no experience working with the human anatomy. As a result, I had to teach
`
`him about the biology of the human heart and related anatomical structures so that he
`
`could give me the help I required. This took considerable time, in part because Dr.
`
`Hsieh spoke limited English.
`
`37.
`
`I met with Dr. Hsieh on a regular basis from September 1999
`
`through March 2000 as often as our schedules would allow. The meetings lasted
`
`hours. I shared with Dr. Hsieh my detailed knowledge about how the heart
`
`functioned, and he shared with me his engineering ideas. He also introduced me to
`
`personnel in the physical plant at the University of Missouri. The physical plant built
`
`whatever the Department of Engineering required.
`
`-17-
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`NORRED EXHIBIT 2093 - Page 17
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`
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`38.
`
`I convinced personnel in the physical plant to assist me with
`
`building a rough prototype of my invention. I purchased pig hearts from a local
`
`slaughterhouse, froze them with liquid nitrogen, and injected them with epoxy. Once
`
`the epoxy hardened, I removed it. I then took a cast of the epoxy using cement. This
`
`gave me a cement model of the aorta and the aortic valve contained therein. He
`
`heated a slotted Nitinol tube and pressed it over the aortic valve cast to create a
`
`Nitinol stent.
`
`39. Dr. Greg Flaker, the Interim Director of the Division of
`
`Cardiology at the University of Missouri, praised me for developing this prototype.
`
`Filed as Exhibit 2083 is an April 5, 2000 letter I received from Dr. Flaker
`
`memorializing a prior, in-person meeting between the two of us.
`
`40. My meetings with Dr. Hsieh were useful in terms of giving me
`
`confidence that a stent solution would work. In the end, however, Dr. Hsieh was
`
`unable to develop the mathematical model I needed for a proof of concept. He
`
`referred me to Dr. Stephen J. Lombardo for further guidance.
`
`41. Dr. Lombardo was an Assistant Professor in the Department of
`
`Chemical Engineering at the University of Missouri. I spoke with Dr. Lombardo by
`
`phone in March 2000 and explained to him what I was trying to accomplish. He
`
`agreed to help, picking up where Dr. Hsieh had left off.
`
`-18-
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`NORRED EXHIBIT 2093 - Page 18
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`
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`42.
`
`For the next few months, from April 2000 until June 2000, I
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`worked with Dr. Lombardo on the project. We spoke two or three times per month,
`
`with me giving Dr. Lombardo the same sort of information I gave to Dr. Hsieh. I
`
`also reviewed scores of peer-reviewed articles on treatments for aortic stenosis,
`
`hoping to gain information regarding such things as the size of valvuloplasty balloons
`
`used in existing treatments and the pressure utilized in such balloons in order to open
`
`aortic passageways. Further, I researched the size of stents used in treatments for
`
`other common aortic ailments. I spent 10-15 hours per week on this project, because
`
`I thought this information could help augment Dr. Lombardo’s work. My efforts are
`
`illustrated by Exhibit 2032, an order for certain of the articles I sought to review.
`
`43.
`
`In May 2000, I met with James J. Kernell, a patent attorney with
`
`the law firm then known as Chase & Yakimo, L.C. By this point, I had devoted
`
`countless hours to my idea for a percutaneously-placed, prosthetic aortic valve. I
`
`believed, based on comments I received from Drs. Hsieh and Lomardo as well as my
`
`own research and experimentation, my idea was viable and would revolutionize the
`
`treatment of aortic stenosis. I wanted to protect my idea, and so I retained Mr.
`
`Kernell to prepare and file a patent application on my behalf. I provided Mr. Kernell
`
`with sketches of the new valve and background information on how the valve would
`
`work. These materials are collected as Exhibit 2050. I subsequently commissioned
`
`and provided Mr. Kernell with a computer animation showing the prosthetic valve
`
`-19-
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`NORRED EXHIBIT 2093 - Page 19
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`
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`being placed in the aorta, and how the valve opened and closed in response to blood
`
`being pumped by the heart.
`
`44. On June 7, 2000, Dr. Lombardo completed his work. Through
`
`mathematical derivation, he was able to come up a load-bearing equation confirming
`
`that a prosthetic aortic valve could be held in place by a stent that was well within the
`
`size range tolerated by the adult human anatomy. The initial draft of the equation I
`
`received from Dr. Lombardo is Exhibit 2084. Dr. Lombardo’s handwritten notes
`
`reflecting some of this work are Exhibit 2019.
`
`45.
`
`As I waited for Mr. Kernell to finish preparing the patent
`
`application, I prepared a proposal for my fellowship project. The goal of my project
`
`was to demonstrate the feasibility of a percutaneously-placed aortic valve using 10 live
`
`pigs as models.
`
`46. My proposal went through numerous iterations. I worked on it in
`
`some form or fashion every day. The earliest drafts were somewhat rudimentary, and
`
`provided little background on the need for or utility of the invention. These drafts are
`
`typified by Exhibit 2037.
`
`47.
`
`Over
`
`time, I
`
`incorporated more and more background
`
`information, hoping to bolster the likelihood that my proposal would be accepted.
`
`Exhibits 2041, 2042 and 2051 show the progression of my work. These drafts include
`
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`NORRED EXHIBIT 2093 - Page 20
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`
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`an extensive discussion of the aortic valve anatomy as well as the risks and
`
`complications of surgical therapy.
`
`48.
`
`The final version of my proposal is filed as Exhibit 2085. With
`
`revisions, it took over 150 hours to complete. It details the costs associated with the
`
`project and the people I intended to enlist for help. These people included Drs.
`
`Hsieh and Lombardo, who had assisted me in earlier stages of my work, as well as Dr.
`
`Timothy T. Catchings. Dr. Catchings was third-year fellow in the Department of
`
`Cardiology when I first met him, and later became an Assistant Professor of Medicine
`
`and the Director of the Coronary Care Unit at the University of Missouri. I began
`
`consulting with Dr. Catchings in the fall of 1999 to gain additional insight into
`
`existing therapies for aortic stenosis, and the need for and utility of non-surgical
`
`treatment options.
`
`49.
`
`As I was working on the proposal for my fellowship project, I
`
`reached out to medical device manufactures such as Guidant Corporation, Boston
`
`Scientific and Medtronic to gauge their interest in participating in the project. Exhibit
`
`2017 is a mutual confidentiality agreement I faxed to a Guidant representative on July
`
`28, 2000 to facilitate communications regarding my invention. Exhibit 2035 is a copy
`
`of a letter to Dr. Greg Flaker, Chair of Cardiology Department at the University of
`
`Missouri, reporting on these discussions and the proposed project. Exhibits 2078 and
`
`2079 are copies of the business cards of some of the other manufacturer
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`NORRED EXHIBIT 2093 - Page 21
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`
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`representatives with whom I spoke. Exhibit 2077 is a telephone directory with
`
`handwritten notes reflecting my conversations with medical device representatives.
`
`Exhibits 2086 and 2087 are documents related to my meeting with Boston Scientific.
`
`50.
`
`In the fall of 2000, I submitted my proposal to Dr. Flaker. Dr.
`
`Flaker said he would approve the project if I first could secure approval from Dr.
`
`Sturek in the Department of Veterinary Medicine. This was appropriate, in Dr.
`
`Flaker’s view, because my project involved placing stents in live pigs, and Dr. Sturek
`
`already had done work in that area.
`
`51. Despite persistent efforts, I was unable to obtain Dr. Sturek’s
`
`approval for my project. I could not convince him my project was technologically
`
`feasible. This left me unable to move forward. I did not have the financial resources
`
`to conduct the project on my own. The equipment needed for the project cost tens
`
`of thousands of dollars. More importantly, absent approval to conduct the project as
`
`part of my fellowship, I could not divert any more time from my clinical
`
`responsibilities. It bears reiterating that my fellowship was a full-time-plus job.
`
`52. On September 22, 2000, I received a draft of the patent
`
`application for the percutaneously-placed, prosthetic aortic valve, Exhibit 2044. A
`
`copy of the transmittal letter from James J. Kernell is filed as Exhibit 2016. I
`
`reviewed the draft of the patent application and provided edits, additions and
`
`comments.
`
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`NORRED EXHIBIT 2093 - Page 22
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`
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`53.
`
`The patent application was filed with the United States Patent and
`
`Trademark Office on November 14, 2000.
`
`54. Once the patent for my invention was on file, I decided to wait
`
`for the patent office to determine if my invention was patentable.
`
`55. On. November 19, 2002, I was granted U.S. Patent No. 6,482,228.
`
`Patentability Over Prior Art
`
`56.
`
`As a board certified interventional cardiologist, I am at least a
`
`person of ordinary skill in the art as pertains to the ‘228 Patent. I designed my
`
`invention to be understood by a person possessing a Doctor of Medicine from an
`
`accredited medical school, plus at least three years of residency in internal medicine or
`
`the equivalent in surgical residency, plus at least three years of cardiology fellowship
`
`or the equivalent in cardiovascular surgery.
`
`57.
`
`At the time I completed my invention, as I conceived the
`
`invention, it was generally patentable over the prior art known to me.
`
`58.
`
`As discussed elsewhere herein, the driving force behind my
`
`invention was the desire to serve the patient population that could not tolerate
`
`surgery.
`
`-23-
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`NORRED EXHIBIT 2093 - Page 23
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`59.
`
`Toward that end, my invention inherently incorporates or was
`
`intended to incorporate1 only components that could be collapsed to fit within a
`
`catheter without losing their original shape or size. If my invention did not
`
`incorporate these components, it would not fit within a catheter as is necessary for
`
`percutaneous placement, and therefore could not serve the purpose for which it was
`
`intended.
`
`60.
`
`Equally important, my invention inherently incorporates or was
`
`intended to incorporate components that would anchor the device in place in the
`
`aorta without sutures. If sutures were necessary to anchor the device, then surgery
`
`would be necessary to anchor the device, and my invention could not serve the
`
`purpose for which it was intended. At the time of my invention, as is true today,
`
`there was no way to suture a heart valve in place percutaneously.
`
`61.
`
`Finally, my invention inherently incorporates or was intended to
`
`incorporate components that would seal the device against the root of the native valve
`
`upon placement without sutures. A seal is necessary to reduce perivalvular leaks. If
`
`1 Here and elsewhere in my declaration, I use the “was intended to” phraseology in
`
`recognition of the fact that the Patent Trial and Appeals Board has construed certain
`
`claim terms in such a manner as to omit certain limitations that I viewed as inherent in
`
`my invention.
`
`-24-
`
`NORRED EXHIBIT 2093 - Page 24
`
`
`
`sutures were necessary to create a seal, then surgery would be necessary to create a
`
`seal, and my invention could not serve the purpose for which it was intended.
`
`62.
`
`As conceived and as embodied in the drawing filed as Exhibit
`
`2003 and the specification for the ‘228 Patent, my invention incorporates a stent
`
`system that extends into the ascending aorta. At the time my invention was
`
`completed, a person of ordinary skill in the art understood that a stent system could
`
`be collapsed to fit within a catheter without losing its original shape and size. My
`
`invention relies on the stent system alone to anchor the device and eliminate the need
`
`for sutures and other means of active fixation. Once expanded in the aortic channel,
`
`the interconnected rods of the stent system exert radial force against the aortic wall to
`
`maintain the device in place.
`
`63.
`
`As conceived and as embodied in the drawing filed as Exhibit
`
`2003 and the specification for the ‘228 Patent, my invention incorporates a pliable,
`
`biocompatible ring member. It is essential that the ring member be pliable so it can
`
`adapt to the irregular shape of the aorta and to the aorta’s continual expansions and
`
`contractions in order to seat about the aortic wall. This enables the ring member to
`
`fulfill its central purpose, which it is to seal against the root of the native aortic valve
`
`to reduce perivalvular leaks and prevent aortic regurgitation. A prosthetic aortic valve
`
`that failed to reduce perivalvular leaks would not have been acceptable to a person of
`
`-25-
`
`NORRED EXHIBIT 2093 - Page 25
`
`
`
`ordinary skill in the art because such leaks can lead to heart failure, hemolytic anemia,
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`infective endocarditis and death.
`
`64.
`
`At the time my invention was completed, most prosthetic valve
`
`designs incorporated rigid components that could not be collapsed to fit within a
`
`catheter. This is true, for example, of Wolfe, US 4,030,142, published June 21, 1977,
`
`and Shu, US 6,139,575 published October 31, 2000. Wolfe incorporates a “hard,
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`rigid, cast supporting ring” as part of its design, while Shu features a “relatively rigid
`
`valve leaflet skeleton.” Neither these valves nor valves containing these sorts of rigid
`
`components, such as
`
`the widely-used Starr-Edwards valve, can be placed
`
`percutaneously.
`
`65.
`
`In addition to incorporating rigid components, at the time my
`
`invention was completed, most valve designs anchored in place with sutures. This is
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`true, for example, of Kischer, US 3,548,417, filed December 22, 1970. Kischer
`
`specifically provides that “[t]he valve is sutured at the base 16 to the artery wall 28 as
`
`by thread extending about or through the base, and typically about reinforcement 54
`
`as seen at 100 in FIG. 4.” This procedure cannot be performed through a catheter.
`
`66.
`
`Another design variation is presented by Ersek, US 3,657,744,
`
`published April 25, 1972. Ersek anchors in place through the expansion of a
`
`deformable sleeve rather than through suturing. In order to deploy the device in the
`
`first instance, however, a surgical incision must be made in the aorta so that the native
`
`-26-
`
`NORRED EXHIBIT 2093 - Page 26
`
`
`
`valve can be removed and so that an expander tool—which carries the device—can
`
`be inserted. The device is not designed for percutaneous placement or for placement
`
`in or adjacent to the native valve.
`
`67.
`
`At the time my invention was completed, there were a handful of
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`prosthetic aortic valves that were designed for percutaneous placement. However,
`
`these designs suffered from fundamental flaws that precluded their clinical
`
`application.
`
`68.
`
`First, certain of these designs lacked a structural component to
`
`seal the device against the root of the native aortic valve to reduce perivalvular leaks.
`
`This is illustrated by Anderson, US 5,411,552, published May 2, 1995. Anderson
`
`features an elastically collapsible valve mounted on an elastical stent. This
`
`construction allows the device to be placed percutaneously. Yet, neither the stent nor
`
`the valve is designed to seal or is capable of sealing the device against the root of the
`
`native aortic valve. As a result, there is a pronounced lack of fluid integrity between
`
`the device and the body lumen. This can be observed in the color photograph of the
`
`device as it appears in Exhibit 2088, Anderson HR, History of Percutaneous Aortic Valve
`
`Prosthesis, Herz 2009; 34:343-6. The valve is sutured to the stent. The stent, then, is
`
`placed in direct contact with the aortic wall. There is nothing to prevent blood from
`
`flowing between and around the loops of the stent. Perivalvular leaks will occur,
`
`which over time, could cause the device to fail.
`
`-27-
`
`NORRED EXHIBIT 2093 - Page 27
`
`
`
`69.
`
`The same problem is found in Bailey, US 6,458,153 B12,
`
`published October 1, 2002; Shaolian, US 6,299,637 B1, published October 9, 20012;
`
`Jayaraman, US 5,855,597, published January 5 1999; Ersek, US 3,657,744, published
`
`April 25, 1972; and Garrison, US 6,425,916 B1, published July 30, 2002. It also is
`
`found in Figulla, German Patent App. No. DE 195-46-692, and Fraunhofer, German
`
`Patent App. No. 198-57-887. None of these designs contain a structural component
`
`2 I reference Shaolian because it is referenced in one of Medtronic’s Petitions for Inter
`
`Partes review. A person of ordinary skill in the art would not consider Shaolian as a
`
`prosthetic aortic valve at all. Shaolian was specifically designed for low-pressure,
`
`venous applications. Shaolian, 2:38-60. The valve remains normally open, but
`
`closes under slight backflow. Id. In contrast, an aortic valve must continually open
`
`and close in coordination with the heart’s contractions to facilitate the smooth and
`
`continual propulsion of blood. Further, as Shaolian notes, “[p]rosthetic heart valves
`
`are usually made from porcine valves, which have a geometry unsuitable as a
`
`replacement for venous valves. These types of valves are also generally larger than
`
`venous valves, and include valve leaflets generally thicker and stiffer than the leaflets
`
`of venous valves. The thicker valve leaflets require a greater opening pressure, which
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