throbber
UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`EDWARDS LIFESCIENCES CORPORATION, EDWARDS
`LIFESCIENCES LLC, AND EDWARDS LIFESCIENCES AG,
`
`Petitioners,
`
`v.
`
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Patent Owner.
`_______________
`
`Case IPR2017-00060
`Patent 8,992,608 B2
`_______________
`
`Before the Honorable NEIL T. POWELL, JAMES A. TARTAL, and
`ROBERT L. KINDER, Administrative Patent Judges.
`
`DECLARATION OF STEPHEN J. D. BRECKER
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Page 1 of 113
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2080
`
`

`

`TABLE OF CONTENTS
`
`INTRODUCTION ...............................................................................................1
`I.
`BACKGROUND OF TRANSCATHETER AORTIC HEART VALVES .....4
`II.
`A. Aortic Valve Disease.....................................................................................4
`B.
`TAVR ............................................................................................................9
`C. Migration And Leakage Of TAVR Devices ...............................................10
`D.
`Types Of Leakage With TAVR Devices ....................................................16
`III. OBVIOUSNESS.............................................................................................21
`IV. THE LEVEL OF ORDINARY SKILL IN THE ART...................................22
`V.
`The ‘608 Patent...............................................................................................23
`A.
`The ‘608 Patent ...........................................................................................23
`VI. THE SCOPE AND CONTENT OF THE PRIOR ART AND THE
`DIFFERENCES BETWEEN THE CLAIMED INVENTION AND THE PRIOR
`ART 25
`A.
`Spenser ........................................................................................................25
`B.
`Elliot ............................................................................................................31
`C.
`Thornton ......................................................................................................34
`D. Cook ............................................................................................................37
`E. Other Pieces Of Prior Art Discussed By Dr. Buller....................................38
`VII. THERE WAS NO REASON OR MOTIVATION TO PUT A BUNCHED-
`UP FABRIC SKIRT AROUND THE OUTSIDE OF SPENSER IN VIEW OF
`ELLIOT, THORNTON, OR COOK........................................................................39
`A.
`Spenser Addresses Different Problems Than Elliot, Thornton And Cook.39
`B. Modifying Spenser’s Cuff/Sleeve To Include Flaps That Extend Into Gaps
`Formed by Native Valve Leaflets Is Contrary To Spenser..................................41
`C. A Person Of Ordinary Skill Was Discouraged From Modifying Spenser’s
`Cuff/Sleeve To Include Flaps That Extend Into Gaps Formed By Native Valve
`Leaflets. ................................................................................................................42
`VIII. THE SAPIEN 3 TAVR DEVICE EMBODIES THE ELEMENTS OF
`CLAIMS 1-3 OF THE ‘608 PATENT ....................................................................45
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`I, Stephen J. D. Brecker, state and declare as follows:
`
`I.
`
`INTRODUCTION
`
`1.
`
`2.
`
`I am over the age of 21 and am competent to make this declaration.
`
`I am an interventional cardiologist with a special interest in adult
`
`structural heart disease and valvular intervention. I have over 25 years of medical
`
`experience as a practicing interventional cardiologist. I am the Chief of
`
`Cardiology at St. George’s University Hospitals in London, U.K. I have
`
`performed over eleven hundred transcatheter aortic valve replacement (“TAVR”)
`
`procedures.
`
`3.
`
`I graduated from St. Thomas’ Hospital, London in 1984.
`
`Subsequently, I completed senior house officer posts at the Hammersmith
`
`Hospital, the Brompton Hospital, and the National Hospital for Nervous Diseases.
`
`I then completed registrar training in cardiology at St. Thomas’ Hospital and the
`
`London Chest Hospital, before taking up a British Heart Foundation Junior
`
`Research Fellowship at the Royal Brompton Hospital. I was also a visiting fellow
`
`at Johns Hopkins Hospital, Baltimore, before becoming a Consultant Cardiologist
`
`and Honorary Senior Lecturer at St. George’s in 1996. I am now Professor of
`
`Cardiology and Chief of Cardiology Clinical Academic Group at St. George’s
`
`University Hospitals.
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`4.
`
`My full qualifications are set forth in my CV, attached hereto at
`
`Appendix A.
`
`5.
`
`I have proctored over 600 TAVR procedures in which I assist and
`
`teach other physicians how to perform TAVR. I have been and remain a Global
`
`proctor for Medtronic since 2010 at approximately 80 centers worldwide, including
`
`over 50 medical centers in the USA for the US Pivotal Trial of the Corevalve
`
`product. I have also proctored the TAVR procedure in the UK, Denmark,
`
`Belgium, Japan, India, Israel, Holland, Austria, Greece, and South Korea.
`
`6.
`
`I have performed TAVR procedures with Medtronic’s Corevalve and
`
`EvolutR products, as well as Boston Scientific’s Lotus product and Edwards’
`
`Sapien products.
`
`7.
`
`I have been active in the field of TAVR as a clinician, researcher,
`
`teacher, and innovator, and I have performed over 1,100 percutaneous TAVR
`
`procedures since 2007.
`
`8.
`
`I have been a practicing cardiologist since 1996 and I am aware of the
`
`technological advances since then.
`
`9.
`
`I have experience, since 1996, of looking after cardiology patients
`
`with thoracic and abdominal aortic aneurysms and have over more than 20 years,
`
`worked closely with our vascular team in their management. St. George’s
`
`Vascular Surgery are considered international leaders in this field and have carried
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`out many of the pivotal clinical trials in this area. I refer these patients for
`
`assessment and treatment and look after them before and after. On a daily basis I
`
`have always interacted with our vascular team and discussed cross-over
`
`technologies between our subspecialties. I have implanted covered coronary stents
`
`and peripheral stent grafts (probably around 10-15 procedures for management of
`
`iliofemoral perforations following TAVR procedures since 2007).
`
`10.
`
`I am a named inventor on one patent, describing a specific TAVR
`
`guidewire, acquired by Medtronic and two patent applications, one for a trans-
`
`catheter mitral valve, another for novel temporary pacing wire.
`
`11.
`
`I am a Fellow of the Royal College of Physicians, the European
`
`Society of Cardiology, the American College of Cardiology, the British
`
`Cardiovascular Society, and the British Cardiovascular Intervention Society.
`
`12.
`
`I am the author or co-author of four books, 16 book chapters, and
`
`more than 100 peer-reviewed articles.
`
`13.
`
`For my time, I am being compensated at $800 per hour, my standard
`
`rate for this type of consulting activity. My compensation is in no way contingent
`
`on the results of these or any other legal proceedings.
`
`14.
`
`I have reviewed U.S. Patent No. 8,992,608 (the “‘608 patent”), the
`
`Petition in this proceeding, the Board’s Institution Decision, the Patent Owner’s
`
`Preliminary Response, Dr. Buller’s declaration regarding the ‘608 patent and
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`materials that it cites, as well as his deposition transcript from June 15, 2017, the
`
`Spenser, Elliot, Thornton, and Cook prior art references, and U.S. Patent No.
`
`7,276,078. I provide the following opinions regarding these materials.
`
`II.
`
`BACKGROUND OF TRANSCATHETER AORTIC HEART VALVES
`
`A.
`
`15.
`
`Aortic Valve Disease
`
`The aorta is the arterial structure through which all of the oxygenated
`
`blood from the heart flows to the rest of the body. The aortic valve, shown in the
`
`image below, is positioned between the aorta and left ventricle and under normal
`
`circumstances allows an unimpeded one-way flow of blood out of the heart.
`
`(Ex. 2069.)
`
`16. Aortic valves are usually tricuspid, meaning they are formed of three
`
`flexible leaflets (some patients present with a two-leaflet, bicuspid valve, which is
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`abnormal). The leaflets extend upward from the aortic annulus into the aorta. The
`
`annulus is a “virtual” ring identified by a line joining each nadir of the three cusps,
`
`i.e., a line joining the insertion points of the three cusps of the aortic valve at the
`
`junction of the aorta and left ventricle and about which the leaflets flex. When the
`
`left ventricle of the heart contracts, beginning the cycle of systole, blood is forced
`
`up through the leaflets, which are opened by the pressure increase in the left
`
`ventricle and the flow of the blood through the valve. When the left ventricle has
`
`finished contracting, which begins the cycle of diastole, the pressure in the heart
`
`falls rapidly and the blood pressure in the aorta exceeds left ventricular pressure so
`
`causing the valve leaflets to close backwards, so preventing blood from travelling
`
`back into the heart. Without the one-way action of the valve, the heart could not
`
`pump blood to maintain life.
`
`17.
`
`The aorta is the body’s largest artery, and it contains a significant
`
`volume of blood at high pressure. During diastole, this blood moves back into the
`
`valve, pressing on the leaflets and forcing them to close against each other. This
`
`constant action places forces on the leaflets as they must, when closed, withstand
`
`the pressure of blood in the aorta.
`
`18. Aortic valves can become diseased, resulting in hardened, calcified
`
`valves that have narrow (“stenotic”) openings, restricting blood flow from the
`
`heart. Diseased valves also may not close completely and therefore can allow
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`blood to back-flow into the heart. Images of healthy and diseased valves are
`
`shown below:
`
`Stenotic Valve
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`(Ex. 2070; Ex. 2071; Ex. 2081.) The image of a diseased valve immediately above
`
`shows calcifications around the leaflets and commissures, which would create
`
`irregularities around a TAVR device when implanted in the aortic annulus.
`
`19. Calcific aortic stenosis is the most common valvular heart disease in
`
`the Western World, afflicting roughly two percent of persons over 65 years of age.
`
`(Ex. 2072 at 15.) Before modern treatments, about 50% of patients would die
`
`within two years of diagnosis. (Ex. 2001 at 4.)
`
`20. Before the advent of TAVR, diseased aortic valves could be treated
`
`via open heart surgery by excising the valve from the patient and sewing a
`
`prosthetic valve in its place. Three examples of surgical prosthetic valves are
`
`shown below:
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`(Ex. 2073; Ex. 2074; Ex. 2075.) Prosthetic valve surgery was effective and
`
`significantly reduced the mortality from aortic valve disease. However, open heart
`
`surgery carries significant risks, and many patients who were considered too high
`
`risk for surgery would not be offered the operation. (Ex. 2072 at 20-21.) These
`
`valves incorporate a sewing ring made of material into which the surgeon places
`
`the sutures. The sewing ring is for the primary purpose of being an anchor for
`
`sutures between the valve and the native aortic tissue. It was never considered a
`
`“sealing” ring, but rather a sewing ring, and the sewing ring does not extend into
`
`gaps formed by native valve leaflets, because these are removed by the surgeon
`
`before implantation of the device.
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`B.
`
`21.
`
`TAVR
`
`Transcatheter aortic valve replacement, known as “TAVR” (also
`
`known as TAVI—transcatheter aortic valve implantation), is a much less invasive
`
`procedure in which a replacement valve is delivered on a catheter through a small
`
`puncture in the leg, under the collar bone, or through the chest. A TAVR valve is
`
`initially collapsed into a diameter small enough to be passed through the patient’s
`
`vasculature to the heart. It is important that the diameter be small enough for
`
`passage through the relatively narrow arteries in the leg or under the collar bone.
`
`A small diameter also makes insertion of the valve and movement of the valve to
`
`the aortic annulus less traumatic to the patient’s blood vessels. A person of
`
`ordinary skill in the art in 2004 would have known that having a small profile was
`
`of primary importance in the design of a TAVR valve—the valve and the delivery
`
`system had to be made small in order for the procedure to be viable from the
`
`percutaneous approach.
`
`22. When the TAVR valve reaches the site of the native aortic valve, it is
`
`expanded inside the native leaflets to a larger diameter. With surgical valve
`
`replacement the diseased native valve leaflets are removed and the aortic annulus
`
`is refashioned by the surgeon to be as regular and round as possible (and
`
`sometimes enlarged), to ensure the best fit of the valve and to ease suturing of the
`
`surgical valve so preventing leakage around the valve. By contrast, with TAVR,
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`the native valve leaflets are not removed but instead pushed aside by the expanded
`
`frame of the TAVR device implanted inside them. The native leaflets are
`
`compressed between the frame of the TAVR device and the aortic annulus. The
`
`replacement valve leaflets inside the device, which have been made of animal
`
`tissue, then take over the role of the native valve in permitting blood to flow in
`
`only one direction and thereby permit the normal function of the heart. (Ex. 2001
`
`at 9-10.)
`
`23.
`
`There is a fundamental difference between the purpose of the sewing
`
`ring, which is present to enable the surgeon to suture the surgical valve into a
`
`smooth, refashioned aortic annulus, and a bunched-up seal on a TAVR device,
`
`which is designed to fill gaps between the native valve leaflets and prevent blood
`
`from passing between the seal and the heart tissue.
`
`C. Migration And Leakage Of TAVR Devices
`
`24. Around the advent of TAVR in the early-2000s, clinicians understood
`
`that paravalvular leakage or “PVL” might be a drawback of TAVR. PVL is the
`
`leakage of blood around the outside of the frame during diastole. With the older,
`
`surgically implanted valves, this problem was seen only rarely because those
`
`devices were tightly sewn to the walls of the aortic annulus. TAVR devices, by
`
`contrast, were implanted by expanding them into the diseased aortic valve site,
`
`which was almost always irregularly-shaped (i.e., not circular) and heavily
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`calcified, which can be extremely resistant to deformation. In addition, the basic
`
`anatomy of the aortic annulus includes three gaps between each pair of adjacent
`
`leaflets when the leaflets are open. These “gaps” where the leaflets come together
`
`are known as commissures.
`
`25. Although persons of skill in the art in the early-2000s had concerns
`
`that these three gaps and the calcifications would result in PVL around a circular
`
`TAVR device, they were more concerned about whether the device a) worked at
`
`all and b) was even possible to implant. Thus, at this early stage of TAVR, PVL
`
`was far from a primary concern. By far the most critical concern at the time was
`
`being able to implant the device at all, and then being able to implant it in the
`
`correct and stable position, i.e., that the valve remains in the correct place. It was
`
`well recognised at this time that devices might migrate, i.e., move from their
`
`implanted position. Such movement can be in the form of “displacement,” which
`
`describes a small movement from the implanted position. A displaced valve may
`
`still function as a valve but could be associated with significant PVL or obstruction
`
`of coronary arteries, both of which pose significant risks to the patient. Another
`
`form of movement can be in the form of “embolisation,” which describes
`
`movement of the valve to an entirely different position within the circulation, for
`
`example, the left ventricle or descending aorta. An embolised valve poses
`
`significant patient risk and may be fatal.
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`26.
`
`TAVR devices have never been sewn into the body, but they are held
`
`in place by what is known as “radial force,” i.e., an outward compressive force
`
`pressing the frame into the surrounding tissues and thus were held in place by
`
`virtue of a tight fit between the outer surface of the device and the diseased native
`
`valve leaflets. Some other design concepts have been to use hooks, barbs, or other
`
`anchoring structures to hold the device in place. Preventing migration was critical
`
`because if the device were dislodged from the annulus, it would almost certainly
`
`fail, as described above. Thus even if the device moved only a small amount, a
`
`number of problems could arise, including: a gap between the device and the
`
`annulus, which could result in severe, potentially fatal, leakage; blockage of the
`
`coronary arteries, which supply blood to the heart; or interference with the left
`
`ventricular outflow tract (“LVOT”), which could impair the conducting system of
`
`the heart. In more severe scenarios, the valve could be embolised completely out
`
`of the aortic annulus in the direction of the flow of blood during systole and travel
`
`downstream to the aorta or even to the aortic bifurcation. This could have a fatal
`
`outcome. The back pressure on the valve when closed in diastole places a
`
`downward force on the TAVR valve that could cause displacement into the left
`
`ventricle with severe consequences. The forward pressure on the valve in systole
`
`even when the valve is open could cause migration into the aorta with severe
`
`consequences. In short, given the potentially fatal results that could occur if the
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`valve migrated, and given the fact that TAVR valves were not held in place by
`
`sutures, persons of ordinary skill in the art in June 2004 were far more concerned
`
`about being able to deliver the valve to the correct and stable position so as to
`
`avoid migration. Persons of skill would have been very well aware of the
`
`consequences of displacement and embolisation of other intracardiac implanted
`
`devices including, for example, septal closure devices and coronary stents. In
`
`2004, I had personally experienced patients who had had these latter complications
`
`at the time.
`
`27. Mild PVL was much less of a concern at the time because it was not
`
`considered to significantly affect patient mortality (the chance that a patient died
`
`post-procedure). We were aware that patients with mild aortic regurgitation on
`
`their own native valve did not need intervention and mild paravalvar leaks around
`
`a surgical valve could usually be left alone. Persons of ordinary skill at the time
`
`would have accepted mild paravalvar leak without concern in 2004—indeed, this
`
`was accepted in 2007 when I started implanting TAVR devices clinically. When
`
`we put the valve in place and the patient was alive at the time, and we still saw
`
`mild PVL, we considered the procedure a success. It was also perceived that the
`
`benefits of the new TAVR over surgery for those who could not have tolerated
`
`surgery vastly outweighed the risks that PVL from a TAVR valve would impose
`
`on the patient.
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`28.
`
`Therefore, in 2004, persons of ordinary skill in the art generally would
`
`not have considered methods, structures, or techniques for reducing PVL in the
`
`early TAVR valves if these would have increased the risk of other issues such as
`
`vascular complications due to larger device size and/or migration.
`
`29. A person of ordinary skill in the art in 2004 would have believed that
`
`a loose-fitting fabric seal on the outside of a TAVR device would have increased
`
`the delivery profile of that device compared to one without the seal. Such a person
`
`would have known that an increase in profile would have directly correlated to an
`
`increase in patient risk due to the potential vascular complications that arise when
`
`delivering larger devices, e.g., damage to the vessel wall, dissections or
`
`perforations through the vessel wall, or an inability to deliver the device to the
`
`target location.
`
`30.
`
`In addition, a person of ordinary skill in the art in 2004 would have
`
`known that the addition of a loose-fitting fabric seal on the outside of the device
`
`could compromise stability of the device within the aortic annulus. With only a
`
`handful of TAVR procedures having been done by 2004, a person of ordinary skill
`
`in the art would have had little real world data on which to base a prediction of the
`
`effect of such an outer seal on the potential for migration.
`
`31.
`
`In light of the above concerns about profile and migration, I do not
`
`believe that persons of ordinary skill in the art would have been motivated to try or
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`even to consider such a structure to resolve PVL around a TAVR device in June
`
`2004. And in my personal experience, I did not consider, and I was not aware of
`
`anyone who had considered, such a seal or the need for one at the time.
`
`32.
`
`In addition, it was believed in June 2004 by persons of ordinary skill
`
`in the art that the metal struts of the stent exposed around the outside of the stent
`
`would compress into and engage the irregular, calcified, native leaflets and that
`
`this engagement would hold the device more firmly in place (anchoring), reducing
`
`the risk of migration. Thus, early TAVR devices that were used in patients did not
`
`have a seal around the outside. A person of ordinary skill at the time would not
`
`have been motivated to undermine the interaction of the bare metal struts with the
`
`native aortic annulus by interposition of a loose-fitting fabric seal around the
`
`outside of the device.
`
`33. As stated, persons of ordinary skill in the art did not believe that mild
`
`PVL would be a significant problem with early-TAVR valves. It was known that
`
`even more severe forms of aortic regurgitation on native valves was in many
`
`patients, well tolerated without the need for surgery. The idea that paravalvar leak
`
`was going to be a major drawback of some valve designs was not really
`
`appreciated until the results of the early clinical trials were published in the late
`
`2000’s. I recall at that time these results were announced the surprise at how
`
`impactful the effect of paravalvar leak was. Since then, TAVR implantation
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`resulting in moderate to severe PVL has been considered unsuccessful, increasing
`
`12-month patient mortality. (Ex. 2004 at 397.)
`
`34.
`
`Edwards’ first commercial TAVR device, known as the Sapien, was
`
`launched in 2007 without an outer seal. Subsequent clinical data showed an
`
`incidence of up to 20.9% moderate to severe PVL with this device after 12 months.
`
`(Ex. 2051 at 38.) Its next-generation device, the Sapien XT, was launched in 2010,
`
`and it also did not have an outer seal. The Sapien XT exhibited even worse PVL:
`
`over 29% moderate to severe PVL after 12 months. (Id.) It was not until
`
`Petitioner’s third generation product, the Sapien 3, launched in 2014, that it added
`
`an outer fabric seal specifically to prevent PVL. (Ex. 2022.) Edwards notes on its
`
`website that this outer seal “virtually eliminates” leakage, and the clinical data of
`
`which I am aware shows substantially reduced PVL with the Sapien 3 versus older
`
`TAVR devices without an outer seal. Studies have shown a 3-4% and less rate of
`
`more than mild PVL. (Ex. 2018 at 44; Ex. 2052 at 3, 26-27.)
`
`D.
`
`35.
`
`Types Of Leakage With TAVR Devices
`
`TAVR devices typically experience leakage in three ways. First,
`
`there can be leakage through the flexible valve leaflets themselves, for example, if
`
`they do not coapt tightly against each other. This through-the-valve leakage is
`
`referred to as “transvalvar regurgitation” illustrated schematically by the drawing
`
`below:
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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2080
`
`

`

`anchor
`
`ANNULUS
`
`ANNULUS
`
`valve
`
`through-the-valve leakage
`
`36.
`
`A second kind of leakage can occur when blood passes from inside
`
`the frame (also called an anchor) through the mesh wall of the frame, and back into
`
`the left ventricle. This through-the-frame leakage is shown schematically in the
`
`drawing below:
`
`- 17 -
`
`Page 19 of 113
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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2080
`
`

`

`anchor
`
`ANNULUS
`
`ANNULUS
`
`valve
`
`through-the-frame leakage
`
`37.
`
`The potential for through-the-frame leakage meant that the bottom of
`
`the valve had to be positioned accurately in the annulus, which was not
`
`straightforward in the early procedures in the early-2000s. To address this, TAVR
`
`concepts at the time included a skirt (also known as a cuff) around the bottom of
`
`the anchor, which would block through-the-frame leakage, as shown schematically
`
`in the drawing below:
`
`- 18 -
`
`Page 20 of 113
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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
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`
`

`

`So long as the skirt was placed in the annulus, the device would not experience
`
`through-the-frame leakage, allowing more leeway in the positioning of the device
`
`during implantation.
`
`38. A third kind of leakage is PVL, which occurs around the outside of
`
`the frame. The skirt used to eliminate through-the-frame leakage, shown above,
`
`was not effective at preventing PVL, which flows around the device as shown
`
`schematically with the drawing below:
`
`- 19 -
`
`Page 21 of 113
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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2080
`
`

`

`PVL
`
`anchor
`
`ANNULUS
`
`ANNULUS
`
`valve
`
`cuff
`
`cuff
`
`PVL
`
`39.
`
`The differences between the through-the-frame leakage and PVL is
`
`important for several reasons. First, they are addressed by different structures. A
`
`tight-fitting skirt to the inside of the frame, for example, can eliminate through-the-
`
`frame leakage, as shown above, but PVL can still occur through the spaces
`
`between the outside of the device and the native valve leaflets. Second, the claims
`
`of the ‘608 patent all require that the fabric seal be adapted to prevent leakage
`
`between the seal and the heart tissue; thus, the claims specifically require a
`
`structure adapted to address PVL rather than through-the-frame leakage.
`
`- 20 -
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`Page 22 of 113
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`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
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`
`

`

`III. OBVIOUSNESS
`
`40.
`
`I am not a patent attorney, and I have been instructed on certain
`
`aspects of the law of obviousness to provide context for my opinions.
`
`41.
`
`I understand that a patent is invalid under 35 U.S.C. § 103 only if “the
`
`differences between the claimed invention and the prior art are such that the
`
`claimed invention as a whole would have been obvious before the effective filing
`
`date of the claimed invention to a person having ordinary skill in the art to which
`
`the claimed invention pertains.”
`
`42.
`
`I understand that obviousness is ultimately a legal question
`
`determined by the Board, but that this legal question is premised on underlying
`
`factual issues, including:
`
`a.
`
`the scope and content of the prior art;
`
`b. the level of ordinary skill in the art;
`
`c.
`
`the differences between the claimed invention and the prior art; and
`
`d. secondary considerations of non-obviousness, such as commercial
`
`success, long-felt need, and the failure of others. I note that I did not
`
`see any discussion in Dr. Buller’s declaration of secondary
`
`considerations of non-obviousness.
`
`- 21 -
`
`Page 23 of 113
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`Edwards Lifesciences v. Boston Scientific Scimed
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`
`

`

`43.
`
`I understand that the scope and content of the prior art must be viewed
`
`through the perspective of a person of ordinary skill in the art at the time of the
`
`invention.
`
`44.
`
`I understand that the relevant time of the obviousness inquiry in this
`
`case is June 16, 2004.
`
`45.
`
`I understand that a patent is obvious merely by demonstrating that
`
`each of its elements was, independently, known in the prior art. I understand that it
`
`is important to identify a reason that would have prompted a person of ordinary
`
`skill in the relevant field to combine the elements in the way the claimed new
`
`invention does. I understand that this rationale must be more than mere conclusory
`
`statements; instead, there must be some articulated reasoning with some rational
`
`underpinning to support the legal conclusion of obviousness. I understand that
`
`such a rationale must include a reason that would have prompted a person of
`
`ordinary skill in the relevant field to combine the elements in the way the claimed
`
`new invention does. I also understand that merely asserting that prior art
`
`references are analogous art to each other is not a sufficient articulated reason with
`
`a rational underpinning to combine their respective teachings.
`
`IV. THE LEVEL OF ORDINARY SKILL IN THE ART
`
`46.
`
`In Dr. Buller’s declaration (Ex. 1007), he opines that a person of
`
`ordinary skill in the art would have been “an interventional cardiologist with a
`
`- 22 -
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`Edwards Lifesciences v. Boston Scientific Scimed
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`
`

`

`working knowledge of heart valve designs and endovascular prostheses, including
`
`expandable stents, stent-grafts, and transcatheter heart valves, including
`
`transcatheter aortic heart valves. This person of ordinary skill in the art would,
`
`where necessary, work as a team in combination with a medical device engineer to
`
`fabricate a THV device.” I agree generally with this definition, however, it is my
`
`opinion that a person of ordinary skill in the art could also include a cardiac
`
`surgeon with experience implanting aortic valve prostheses in the heart.
`
`V.
`
`The ‘608 Patent
`
`A.
`
`47.
`
`The ‘608 Patent
`
`In June 2004, when only a handful of TAVR procedures had ever
`
`been performed in a human patient, the ‘608 patent identified the significance of
`
`PVL that could be addressed by a loose-fitting fabric seal disposed around the
`
`outside the device. First, the patent described leakage due to the irregular, calcific
`
`surfaces of the native valve leaflets:
`
`With reference now to FIG. 13, a risk of paravalvular
`leakage or regurgitation around the apparatus of the
`present invention is described. In FIG. 13, apparatus 10
`has been implanted at the site of diseased aortic valve
`AV . . . .
`The surface of native valve leaflets L is
`irregular, and interface I between leaflets L and anchor
`30 may comprise gaps where blood B may seep through.
`Such leakage poses a risk of blood clot formation or
`insufficient blood flow.
`
`- 23 -
`
`Page 25 of 113
`
`Edwards Lifesciences v. Boston Scientific Scimed
`IPR2017-00060 U.S. Patent 8,992,608
` Exhibit 2080
`
`

`

`“diseased
`aortic valve”
`
`“native valve
`leaflets”
`
`“interface”
`
`“blood”
`
`(‘608 patent col. 12:19-27, FIG. 13.)
`
`48.
`
`The ‘608 pa

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