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
`______________________
`
`Case IPR2014-00395
`Patent 6,482,228
`______________________
`
`DECLARATION OF TIMOTHY CATCHINGS, M.D.
`
`NORRED EXHIBIT 2295 - Page 1
`Medtronic, Inc., Medtronic Vascular,
`Inc., & Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case No. IPR2014-00395
`
`
`______________________
`
`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
`______________________
`
`Case IPR2014-00395
`Patent 6,482,228
`______________________
`
`DECLARATION OF TIMOTHY CATCHINGS, M.D.
`
`NORRED EXHIBIT 2295 - Page 1
`Medtronic, Inc., Medtronic Vascular,
`Inc., & Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case No. IPR2014-00395
`
`
`
`I, Timothy T. Catchings, M.D., declare as follows:
`
`1.
`
`I have been asked by Troy R. Norred, M.D.
`
`to provide my
`
`opinions in this declaration in connection with the iizterparxer review of United States
`
`Patent No. 6,482,228 (the “‘228 patent”).
`
`In preparing this declaration,
`
`I have
`
`reviewed the ‘228 patent, the prosecution history of the ‘228 patent, the prior art cited
`
`by the Patent Trial and Appeal Board in instituting these proceedings, and other prior
`
`art that is or may be pertinent to the patentability of Dr. Norred’s invention. I have
`
`personal knowledge of the following facts and would and could testify competently
`
`regarding the following statements if called as a witness.
`
`2.
`
`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
`
`patents.
`
`I also understand that
`
`they are ordinarily construed based on the plain
`
`meaning of the terms used in the claims, and also with reference to the specification,
`
`the patent drawings, and the prosecution history. In 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 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.
`
`NORRED EXHIBIT 2295 - Page 2
`NORRED EXHIBIT 2295 - Page 2
`
`
`
`3.
`
`In my opinion, a person of ordinary skill in the art would possess
`
`a Doctor of Medicine from an accredited medical school plus at least three yea1's of
`
`residency in internal medicine or the equivalent in surgical residency, plus three years
`
`of cardiology fellowship or the equivalent in cardiovascular surgery.
`
`4.
`
`All of the opinions expressed in this declaration are my own,
`
`formed upon analysis of the materials listed above.
`
`Professional Background
`
`5.
`
`I am a citizen of the United States and a resident of Waycross,
`
`Georgia. My post office address is 1610 Screven Avenue, Waycross, Georgia 31501.
`
`6.
`
`I currently am in private practice in Waycross, Georgia as a board
`
`certified interventional cardiologist.
`
`7.
`
`As part of my practice,
`
`I see and treat patients suffering from
`
`valvular heart disease, including aortic stenosis.
`
`8.
`
`I attended college at Albany State College in Albany, Georgia
`
`from 1974 to 1978, earning a Bachelor of Arts in Chemistry.
`
`I attended medical
`
`school at Emory University School of Medicine in Atlanta, Georgia from 1974 to
`
`1.978, earning a Doctor of Medicine. Following graduation from medical school, from
`
`1978 to 1979,
`
`I worked as an Intern at Medical College of Georgia Affiliated
`
`Hospitals in Augusta, Georgia. Following my internship, from 1980 to 1982, I served
`
`as a Resident at
`
`the Naval Regional Medical Center
`
`in Portsmouth, Virginia.
`
`NORRED EXHIBIT 2295 - Page 3
`NORRED EXHIBIT 2295 - Page 3
`
`
`
`Following my residency, from 1982 to 1984, I was a Fellow in Pulmonary Diseases at
`
`the Naval Hospital in Portsmouth, Virginia. After that, fromjuly 1995 to May 1998, I
`
`was a Fellow in Cardiovascular Diseases at the National Naval Medical Center in
`
`Bethesda, Maryland.
`
`Then,
`
`from July 1999 to July 2000,
`
`I was a Fellow in
`
`Cardiovascular Diseases at the University Hospital of the University of Missouri.
`
`I
`
`was an Assistant Professor of Medicine and the Director of the Coronary Care Unit at
`
`the University Hospital at the University of Missouri from August 2000 until August
`
`2006. After that, I worked in private practice in \Williamsburg, Virginia until October
`
`2008, when I moved to my present position.
`
`9.
`
`I am a Retired Captain in the Medical Corps of the U.S. Navy
`
`Reserve. As part of my military service, I served on the USS Sylvania from 1979 to
`
`1980; at the Naval Regional Medical Center in Portsmouth, Virginia from 1980 to
`
`1982; at the Naval Hospital in Portsmouth, Virginia from 1982 though 1987; at the
`
`Naval Reserve Centers in Macon and Atlanta, Georgia from 1987 to 1995; and at the
`
`National Naval Medical Center in Bethesda, Maryland from 1995 to 1999.
`
`In
`
`addition, from 1990 to 1992,
`
`I was the Director of Medical Services at the Fleet
`
`Hospital 14 Headquarters injacksonville, Florida.
`
`10.
`
`I
`
`am or have been a member of
`
`several professional
`
`organizations, including the American College of Chest Physicians, the Society of
`
`NORRED EXHIBIT 2295 - Page 4
`NORRED EXHIBIT 2295 - Page 4
`
`
`
`Critical Care Medicine, the American Medical Association, the Bibb County Medical
`
`Society, the National Medical Association and the Virginia Thoracic Society.
`
`11.
`
`I hold a license to practice medicine in Georgia, and have
`
`previously held licenses in Virginia, Missouri and Oklahoma.
`
`12.
`
`I am at least a person of ordinary skill in the art as it pertains to
`
`the prosthetic aortic valve invented by Dr. Norred and described in the ‘228 Patent.
`
`T/53 Nafive Aorfic Vafve
`
`13.
`
`The aortic valve is located between the left ventricle and the aorta.
`
`14.
`
`The function of the aortic valve is to allow blood to flow in one
`
`direction, from the left ventricle to the aorta.
`
`15.
`
`The aortic valve opens to allow blood to flow into the aorta, and
`
`closes to prevent back flow into the left ventricle. It does this approximately 103,000
`
`times per day, and approximately 3.7 billion times in its lifespan.
`
`16.
`
`The aortic valve consists of three membranous leaflets and three
`
`aortic sinuses.
`
`17.
`
`The leaflets are the parts of the valve that most directly control
`
`blood flow.
`
`It once was thought that the leaflets were pushed open by the ejection of
`
`blood from the left ventricle. We know now that this View was overly simplistic and
`
`somewhat
`
`inaccurate.
`
`The leaflets are attached to the aortic wall
`
`through
`
`commissures. The commissures move outwardly during systole and inwardly during
`
`‘5'
`
`NORRED EXHIBIT 2295 - Page 5
`NORRED EXHIBIT 2295 - Page 5
`
`
`
`diastole. It is the outwardly movement of the commissures that causes the leaflets to
`
`open.
`
`18.
`
`Comrnissural movement is possible because of the elastic walls of
`
`the sinuses. The sinuses are cavities behind the leaflets, and represent dilations of the
`
`base of the aorta. The sinuses are continuous with the left ventricle at the lower
`
`margin, and form part of the ascending aorta at the upper margin.
`
`19.
`
`The area where each leaflet merges with the other two leaflets to
`
`close the valve is called the coaptation surface. The coaptation surface helps prevent
`
`aortic regurgitation.
`
`20.
`
`The leaflets, commissures and sinuses together form a unit that
`
`allows for the circumferential dispersion of force throughout the valve. This, in turn,
`
`contributes to the longevity of the valve by reducing the stress and strain on the
`
`leaflets themselves.
`
`21.
`
`A cardiac cycle involves the rapid opening of the valve, followed
`
`by the ejection of blood from the heart. The valve is maximally open in early systole,
`
`as the leaflets move into the sinuses. Vortices form between the leaflets and the sinus
`
`walls. As systole continues, the persistence of these vortices combined with the
`
`deceleration of aortic flow causes the leaflets to gradually come together. By the end
`
`of systole, the valve is almost closed. At that point, the leaflets close rapidly and the
`
`heart begins to fill with blood in preparation for the next cycle.
`
`NORRED EXHIBIT 2295 - Page 6
`NORRED EXHIBIT 2295 - Page 6
`
`
`
`Dr. Norredir Im,-emtiorz
`
`22.
`
`Dr. Norred first approached me about his prosthetic aortic valve
`
`in 1999, while we were both at the University of Missouri. At that time, surgical aortic
`
`valve replacement was the state of the art. A person of ordinary skill in the art was
`
`not aware of a prosthetic aortic valve that could be placed in a patient through non-
`
`surgical methods.
`
`23.
`
`Surgical aortic valve replacement
`
`is highly traumatic because,
`
`among other things, it requires that a patient’s heart be stopped and the patient placed
`
`on a cardiopulmonary bypass machine. This limits the types patients for whom
`
`surgical aortic valve replacement is a viable treatment option. Elderly and infirm
`
`patients often are unable to tolerate this surgery and therefore cannot receive a
`
`surgically placed aortic valve.
`
`24.
`
`Dr. Norred suggested that a prosthetic aortic valve could be
`
`placed percutaneously through a catheter held in place with a stent structure.
`
`I
`
`immediately saw the value in this concept, but was skeptical it would work.
`
`I did not
`
`believe the radial force exerted by the stent would be sufficient to anchor the device in
`
`the aorta without damaging the device or the aortic wall or both.
`
`I thought the device
`
`would dislodge or leak.
`
`25.
`
`From the fall of 1999 through the fall of 2000, Dr. Norred and I
`
`had regular discussions regarding the viability of and need for his invention.
`
`J-
`
`NORRED EXHIBIT 2295 - Page 7
`NORRED EXHIBIT 2295 - Page 7
`
`
`
`26.
`
`From my discussions with Dr. Norred, I learned that he was able
`
`to develop, in collaboration with others at the University of Missouri, a mathematical
`
`model to prove that an aortic valve could be held in place with a stent.
`
`27.
`
`From my perspective, this was critical because, absent such proof,
`
`it was unlikely Dr. Norred could garner support for the development and testing of
`
`the device.
`
`I know his objective was to test
`
`the device in live animals for his
`
`fellowship project.
`
`28.
`
`The prosthetic aortic valve invented by Dr. Norred has four
`
`characteristics that a person of ordinary skill in the art would consider functionally
`
`significant.
`
`29.
`
`First, the prosthetic aortic valve invented by Dr. Norred consists
`
`of components that can be collapsed to fit into a catheter. This is what allows the
`
`device to be placed percutaneously. This, primarily, is what distinguishes this device
`
`from prosthetic aortic valves that were on the market at
`
`the time Dr. Norred
`
`conceived his invention. The prosthetic valves that were on the market at that time,
`
`such as the Starr-Edwards valve, St. _]ude’s tilting disk valve and the Medtronic tilting
`
`disk valve, were comprised of rigid components that could never fit within a catheter.
`
`30.
`
`Second,
`
`the prosthetic aortic valve invented by Dr. Norred
`
`anchors in place by the interconnected rods of the stent system exerting radial force
`
`against the aortic wall. This eliminates the need for sutures. This is important
`
`'8‘
`
`NORRED EXHIBIT 2295 - Page 8
`NORRED EXHIBIT 2295 - Page 8
`
`
`
`because suturing cannot be done through a catheter.
`
`It was and remains a surgical
`
`procedure. Eliminating the need for sutures is thus imperative if the device is to be
`
`placed percutaneously.
`
`31.
`
`Third, the prosthetic aortic valve invented by Dr. Norred contains
`
`a stent stnlcture that extends into the ascending aorta. This extended stent structure
`
`allows for the circumferential dispersion of force, mimicking the manner in which the
`
`native valve disperses force through the leaflets, commissures and sinuses acting in
`
`concert with one another. This is important because it reduces the stress and strain
`
`on the leaflets, and contributes toward the longevity of the valve.
`
`In addition,
`
`this
`
`extended stent structure makes it significantly easier to place and correctly align the
`
`prosthetic valve.
`
`32.
`
`Finally,
`
`the prosthetic aortic valve invented by Dr. Norred
`
`contains a structural element—a ring member—to seal it against the root of the native
`
`aortic valve upon placement. This is important because if the device is not sealed
`
`against the root of the native aortic valve upon placement, the high pressures and high
`
`flow of blood within the aorta will cause perivalvular leaks.‘ A prosthetic aortic valve
`
`susceptible to perivalvular leaks would not be acceptable to a person of ordinary skill
`
`‘ As used herein, the term “perivalvular leak” means a leak between the aorta and the
`
`left ventricle.
`
`'9'
`
`NORRED EXHIBIT 2295 - Page 9
`NORRED EXHIBIT 2295 - Page 9
`
`
`
`in the art, because such leaks can lead to heart failure, hemolytic anemia, blood clots,
`
`stroke, infective endocarditis and death?
`
`33.
`
`Referring specifically to the claims of the ‘228 Patent, I would
`
`understand the term “ring member” as used in claims 16 and 20 to mean a ring made
`
`of pliable, biocompatible material. This definition derives from the specification,
`
`Named,
`
`():1—2, and also from the requirement
`
`that
`
`the ring member have a
`
`circumference “adapted” to seat about the aortic wall. The aorta is not a perfectly
`
`circular or cylindrical structure, but rather, has an irregular, oblong shape that differs
`
`from person to person. The adaptation that would allow the ring member to seat
`
`against this irregular, oblong surface is pliability. Further, the aortic wall is not static.
`
`Instead, as discussed elsewhere herein, it is constantly expanding and contracting.
`
`The adaptation that would allow the ring member to seat against this expanding and
`
`contracting surface is pliability. A pliable ring member could move in tandem with
`
`these expansions and contractions without becoming dislodged. Finally,
`
`I would
`
`understand the term “ring member” as used in claims 16 and 20 to mean a ring that
`
`2 Some early designs, such as Wolfe, US 4,030,142, published june 21, 1977, relied
`
`upon leaks and the subsequent formation of clots to maintain a seated position in the
`
`heart.
`
`ll’/oie, 3:61-68. This never would be acceptable to a person of ordinary skill in
`
`the art. These designs were never put into practice.
`
`'10‘
`
`NORRED EXHIBIT 2295 - Page 10
`NORRED EXHIBIT 2295 - Page 10
`
`
`
`seals against the root of the native aortic valve to reduce perivalvulat leaks.
`
`This
`
`definition is consistent with the specification.
`
`Nomad,
`
`6:1—4. Moreover,
`
`this
`
`functionality is vital in order for the prosthetic aortic Valve to be a viable replacement
`
`for the native aortic valve.
`
`34.
`
`I would understand the term “membrane” as used in claim '16 to
`
`be a thin, soft, pliable sheet or layer. This is the ordinary and customary meaning of
`
`“membrane” and one that is consistent with the specification. Norred, l:26~27, 4:16-
`
`19, 4:58-64, 5:40-44.
`
`35.
`
`I would understand the term “means for mounting” as used in
`
`claim 16 to mean hingedly attached or hingedly secured through a material fold, with
`
`the material functioning as a hinge. This is consistent with the specification and is
`
`depicted in Fig. 18.
`
`36.
`
`I would understand the term “means for maintaining” as used in
`
`claim 19 to mean the interconnected rods that form the stent system that extends into
`
`the ascending aorta. This is consistent with the specification. The specification
`
`provides that stent system 28 is made up of a small, slotted stainless steel tube or
`
`series of interconnected rods. Narred, 2:60-62. The stent system 28 is depicted in its
`
`entirety in Fig. 5. The inflow region of the stent system is depicted in Fig. 18. Rods
`
`104 are shown in Fig. 18 as an integrated part of the stent system 28. Nomad, 6:4-7.
`
`-11-
`
`NORRED EXHIBIT 2295 - Page 11
`NORRED EXHIBIT 2295 - Page 11
`
`
`
`37.
`
`I would understand claim 16, constnied in
`
`light of
`
`the
`
`specification, to describe a prosthetic aortic valve comprised of a membrane hingedly
`
`attached or hingedly secured to a ring member, where both the membrane and the
`
`ring member can be collapsed to fit within a catheter for percutaneous delivery,’ and
`
`where the ring member has a pliable circumference in order to seat about the aortic
`
`wall and seal against the root of the native aortic valve to reduce perivalvulat leaks.
`
`38.
`
`I would understand claim 19, construed in light of
`
`the
`
`specification, to mean the prosthetic aortic valve described in claim 16, where the ting
`
`member is attached to the interconnected rods of a stent system that extends into the
`
`ascending aorta and maintains the ring member against the aortic wall.
`
`39.
`
`I would understand claim 20, construed in light of
`
`the
`
`specification, to describe a tissue valve hingedly attached or hingedly secured to a ring
`
`3 I am aware the Board found these claims are not limited to a prosthetic aortic valve
`
`that can be placed percutaneously.
`
`I note, however, these claims specifically refer to
`
`the “placement” of the prosthetic valve. The only form of placement described in the
`
`specification is percutaneous placement. Norrea’, Title, Abstract, 1:7-9, 1:26-27, 1:32-
`
`33, 1:53-55, 1:58-60, 1:67-2:2, 2:55-3:18, 5:63-67. Accordingly, I would read into each
`
`of these claims the requirement that the prosthetic valve be capable of percutaneous
`
`placement.
`
`'12"
`
`NORRED EXHIBIT 2295 — Page 12
`NORRED EXHIBIT 2295 - Page 12
`
`
`
`member, where both the tissue valve and the ring member can be collapsed to fit
`
`within a catheter, where the ring member has a pliable circumference in order to seat
`
`about the aortic wall and seal against the root of the native aortic valve to reduce
`
`perivalvular leaks, and where the ring member is attached to the interconnected rods
`
`of a stent system that extends into the ascending aorta and maintains the ring member
`
`against the aor1:ic wall.
`
`Pa1Fem‘abz'Zz'_zjz qfDr. Narredis‘ Im2em'z'on
`
`40.
`
`I am aware of other prosthetic valves that were designed for or
`
`purportedly capable of percutaneous placement. However, each of these designs
`
`lacks one or more of the attributes that make Dr. Norred’s device viable.
`
`41.
`
`One example is Anderson, US 5,411,552, published May 2, 1995.
`
`Anderson is comprised of an elastically collapsible valve mounted on an elastical stent.
`
`Anderxorz, 2:30-37. This construction allows the device to be placed percutaneously
`
`and to anchor in place without sutures. Anderrozz, 2:56-68, 6:20-44. However,
`
`Anderson lacks a ring member to seal the device against the root of the native aortic
`
`valve. Anderson, 2:28-55, Figs 1 & 2. As a result, there is nothing to prevent blood
`
`from flowing between and around the loops of the stent. Perivalvular leaks will
`
`occur, which could cause immediate, catastrophic, procedural failure resulting in
`
`death. The same problem is found in Bailey, US 6,458,153, published October 1,
`
`2002; jayaraman, US 5,855,597, published January 5 1999; Ersck, US 3,657’,744,
`
`' I 3'
`
`NORRED EXHIBIT 2295 — Page 13
`NORRED EXHIBIT 2295 - Page 13
`
`
`
`published April 25, 1972; and Garrison, US 6,425,916, 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 to seal the device against the root of the native aortic valve.
`
`42.
`
`Dill/Iatteo, US 6,440,164, published August 27, 2002, incorporates
`
`a trellis surrounded by a biocompatible non-thrombogenic liner that is intended to
`
`facilitate tissue ingrowth over time, with this tissue ingrowth eventually creating a seal.
`
`Dzrl/lattes, 4:61-62,
`
`l1:‘l—4. This theory is fundamentally flawed. The pressures and
`
`blood flow in the aorta are too great for tissue ingrowth to occur. If a prosthetic aortic
`
`valve has a perivalvular leak upon placement, it will not seal. A perivalvular leak could
`
`cause immediate, catastrophic procedural failure, resulting in death of the patient.
`
`Because the device described in DiMatteo does not seal upon placement, it would not
`
`be acceptable to a person of ordinary skill in the art.
`
`43.
`
`Leonhardt, US
`
`5,957,949, published September
`
`28,
`
`1999,
`
`describes a valve comprised of a super—elastic spring stent fully enclosed by graft
`
`material coated with light—activated adhesive. L20}:/Jardt, 3:33—45, 6:4—7.
`
`If this device
`
`is placed within the native annulus, graft material must be cut from between the
`
`distensible fingers that are formed by the zig-zags of the stent in order to prevent the
`
`stent from blocking the coronary artery. Leon/Jardt, 6:9-23. The device then must be
`
`placed so that the distensible fingers are on either side of the coronary artery.
`
`Id.
`
`-14-
`
`NORRED EXHIBIT 2295 - Page 14
`NORRED EXHIBIT 2295 — Page 14
`
`
`
`There is no way to ensure such precise placement, even with radiopaque markers, as
`
`these only provide a two—dimensional depiction of the three—dimensional placement
`
`site.
`
`If one of the distensible fingers were to occlude the coronary artery, it would
`
`lead to a myocardial infarction and possibly death. A person of ordinary skill in the
`
`art would consider the risk of occlusion unacceptably high with this device.
`
`44.
`
`Further, because the distensible fingers must be placed on either
`
`side of the coronary artery,
`
`the entirety of the stent structure, except
`
`for
`
`the
`
`distensible fingers, must be below the coronary artery. L.eoz2/Jardt, 5:40-52, Fig. 2. The
`
`device cannot extend into the ascending aorta, and therefore cannot displace force
`
`citcumferendally in a manner mimicking the native valve.
`
`.-\s a result, this valve is
`
`likely to fail}
`
`4 Leonhardt is one of several prosthetic aortic valves that utilize a stent as a mere
`
`substitute for sutures. Because the purpose of the stent in these designs is to anchor
`
`the valve to the aortic wall, the stent typically occupies the same area as the native
`
`aortic valve and does not extend above the coronary artery into the ascending aorta.
`
`The performance of these designs is likely to parallel the performance of surgically-
`
`implanted valves such as the Hancock valve. These valves are unable to displace
`
`force circumferentially, so the leaflets undergo far greater stress and strain than is
`
`experienced by the leaflets in the native valve. This causes these valves to fail.
`
`-15-
`
`NORRED EXHIBIT 2295 - Page 15
`NORRED EXHIBIT 2295 — Page 15
`
`
`
`45.
`
`Additionally, the distensible fingers on the inflow portion of the
`
`Leonhardt valve will interfere with the subvalvular structures of the aorta, such as the
`
`mitral valve, the chordae tendinae, and the membranous septum. Interference with
`
`the mitral valve leaflet and the chordae tendinae could induce mitral regurgitation,
`
`which in turn could result in immediate congestive heart failure.
`
`Interference with the
`
`membranous septum could disrupt the timing function of the heart.
`
`46.
`
`If the Leonhardt device is placed above the native annulus as
`
`depicted in Fig. 3 rather than within the native annulus, cutting graft material will not
`
`prevent the coronary artery from being blocked, because biological valve 22 will block
`
`the coronary artery. Leorz/Jardt, 3:59-61, 6:23-31. Biological valve 22 is a membrane
`
`that will not allow blood flow therethrough.
`
`47.
`
`Leonhardt also is problematic because it does not utilize a ring
`
`member to seal
`
`the device against
`
`the root of the native aortic valve to reduce
`
`perivalvular leaks.
`
`Instead, Leonhardt relies on the stent structure itself to create a
`
`temporary seal. See Lear:/Jardt, 4:55-60, 5:2-5, 5:48-50. This temporary seal allows the
`
`device to be removed or repositioned at will, even after full deployment.
`
`I..eou/Jardz,
`
`3:4~6, 3:27-30, 11:37-53. Once the device is positioned properly, a permanent seal
`
`purportedly is created through activation of the adhesive coating. Leorzfmrdr, 8:43-67,
`
`9:1-5. The adhesive coating purportedly seals the device until it ultimately degrades,
`
`and living tissue takes its place. Lem:/2am’t, 8:43-54, 8:66-67, 9:1. This design would not
`
`-16-
`
`NORRED EXHIBIT 2295 - Page 16
`NORRED EXHIBIT 2295 — Page 16
`
`
`
`be acceptable to a person of ordinary skill in the art. At the time Leonhardt was
`
`published, there were no light—activated adhesives that would work in a wet, high-
`
`pressure environment such as
`
`the aorta.
`
`I am aware of a substance known as
`
`poly(glycerol sebacate acrylate) or PGSA, a mix of glycerol (C31-1803) and sebacic
`
`acid (C101-H804) that is currently in development for this purpose, but clinical trials
`
`have not yet begun on this substance, and it remains unclear whether it could or
`
`would work with the Leonhardt device.
`
`48.
`
`Certain aortic valve designs incorporate stents that as constructed
`
`lead to sharp areas of protrusion. These sharp areas of protrusion are typically
`
`disclosed as barbs, hooks or flanges. These designs include Figulla, German Patent
`
`App. No. DE 195-46-692; Fraunhofer, German Patent App. No. 19867-887;
`
`jayaraman, US 5,855,597, published January 5, 1999; and Bailey, US 6,458,153,
`
`published October 1, 2002. These designs are placed through expansion of the stent.
`
`Expansion of the stent will cause these sharp areas ofprotrusion to come into Contact
`
`with delicate surrounding tissue. This will cause these sharp areas of protrusion to
`
`pierce this tissue, particularly when combined with the high pressures within the aorta
`
`and the Constant expansion and contraction of the aorta and heart. This,
`
`in turn,
`
`could lead to aortic dissection and/ or perforation. As a result, devices employing
`
`these sharp areas of protrusion would not be acceptable to a person of ordinary skill
`
`in the art.
`
`-17-
`
`NORRED EXHIBIT 2295 - Page 17
`NORRED EXHIBIT 2295 — Page 17
`
`
`
`49.
`
`Bailey, US 6,458,153, published October 1, 2002, anchors in place
`
`by means of proximal anchor flange 22, which consists of a plurality of stent struts
`
`and stent interstices that project radially outward from the central longitudinal axis of
`
`the valve stent 10 as depicted in Fig. 1. Bai/e , 9:61-65.
`
`If this device is placed in the
`
`native annulus as shown in Fig. 20H,
`
`these stent struts will
`
`interfere with the
`
`subvalvular structures of the aorta, such as the mitral valve leaflet,
`
`the chordae
`
`tendinae,
`
`the membranous septum and the left ventricular outflow tract.
`
`As
`
`discussed in connection with the Leonhardt device, interference with the mitral valve
`
`leaflet and the chordae tendinae could induce mitral regurgitation, which in turn could
`
`result in immediate congestive heart
`
`failure.
`
`Interference with the membranous
`
`septum could disrupt the timing function of the heart. If anchor flange 22 pierces the
`
`membranous septum, it will cause an immediate ventricular septal defect.
`
`If anchor
`
`flange 22 pierces the left ventricular outflow tract, it could cause exsanguination and
`
`death.
`
`50.
`
`Bailey proposes to avoid these issues by eliminating one or more
`
`stent struts to define an open region where these subvalvular structures are located.
`
`Baife , 9:65-10:14. This
`
`solution is unworkable for
`
`two reasons.
`
`First,
`
`these
`
`subvalvular structures completely surround the inflow portion of the valve, so unless
`
`all stent struts are eliminated, they will interfere with these structures. Second, even if
`
`these subvalvular structures did not completely surround the inflow portion of the
`
`‘1 8'
`
`NORRED EXHIBIT 2295 - Page 18
`NORRED EXHIBIT 2295 — Page 18
`
`
`
`valve, there is no way to place the device with sufficient precision to avoid these
`
`structures. Although radiopaque markets can be employed to assist with placement,
`
`these only provide a two—dimensional depiction of the three—dimensional placement
`
`site. There is an unacceptably high likelihood the device will be placed in a manner
`
`that interferes with or obstructs surrounding structures.
`
`1-"urther, removal of stent
`
`struts will lessen the ability of the flange 22 to anchor the device in place, which
`
`makes it more likely the device will leak or dislodge.
`
`51.
`
`The valve described in Schreck, US 6,454,799, published
`
`September 24, 2002, purports to anchor in place through the combination of a tubular
`
`member, which exerts radial force against the walls of the native aortic valve, and
`
`barbs, staples or flanges as necessary.
`
`Sc/Jreaé, 2:16-36, 13:12-31. The immediate
`
`problem with this design is that the tubular member does not extend into the aorta,
`
`even into the area where the new valve is seated (the new valve is seated directly
`
`above the “tissue engaging base,” which houses the tubular member).
`
`5:.‘/Jrecvé, Figs. 2
`
`& 7. As a result, there is nothing to maintain the new valve against the aortic wall.
`
`When the new valve is exposed to the high pressures within the aorta, the posts 146
`
`and 148 will cantilever towards the center of the device. This will pull the tissue-
`
`engaging base 104 and fabric skirt 110 away from the aortic wall, causing
`
`misalignment of the leaflets 32, perivalvular leaks, and ultimately dislodgmcnt and
`
`failure of the device. See 3:‘/Jl‘E6‘/(3, 8:10-13.
`
`'19‘
`
`NORRED EXHIBIT 2295 - Page 19
`NORRED EXHIBIT 2295 — Page 19
`
`
`
`52.
`
`I have no financial
`
`interest
`
`in D1’. N01'1'ecl’s
`
`invention or the
`
`outcome of these proceedings.
`
`I hereby declare under the penalty of perjury under the laws of the United States of
`
`..-'\me1'ie21 that the foregoing is true and flCCu1’:1tC to the heel’ of In}? knowledge and
`
`understanding.
`
`___‘__
`
`
`Do. +ae_
`
`:......‘._?a-....‘_...
`
`l\3o¥:;"¥L\"‘ ' };.b\ k c.
`
`Vi ‘ I Ht ’ 3.0‘: Li
`
`Notary Pub1ic,Piarca County. Georgia
`My Commission Expires Mar. 3, 2GI5
`
`NORRED EXHIBIT 2295 - Page 20
`NORRED EXHIBIT 2295 - Page 20
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