`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`BOSTON SCIENTIFIC CORP. and
`BOSTON SCIENTIFIC SCIMED, INC.,
`
`Plaintiffs,
`
`v.
`
`EDWARDS LIFESCIENCES CORP.,
`
`Defendant.
`
`EDWARDS LIFESCIENCES CORP.,
`EDWARDS LIFESCIENCES PVT, INC., and
`EDWARDS LIFESCIENCES LLC,
`
`Counterclaim and Third-Party
`Plaintiffs,
`
`v.
`
`BOSTON SCIENTIFIC CORPORATION,
`BOSTON SCIENTIFIC SCIMED, INC., and
`SADRA MEDICAL, INC.,
`
`Counterclaim and Third-Party
`Defendants.
`
`C.A. No. 16-275-SLR-SRF
`
`DECLARATION OF PROFESSOR STEPHEN J.D. BRECKER IN SUPPORT OF
`BOSTON SCIENTIFIC’S REPLY CLAIM CONSTRUCTION BRIEF
`
`I, Stephen J.D. Brecker, state and declare as follows:
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`1.
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`2.
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`I am over the age of 21 and am competent to make this declaration.
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`I am an interventional cardiologist with a special interest in adult structural heart
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`disease and valvular intervention. I have over 25 years of medical experience as a practicing
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`interventional cardiologist. I am the Chief of Cardiology at St. George’s University Hospitals in
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`Page 1
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 1 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 2 of 10 PageID #: 3037
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`London, U.K. I have performed over one thousand transcatheter aortic valve replacement
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`(“TAVR”) procedures.
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`3.
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`I graduated from St. Thomas’ Hospital, London, in 1984. Subsequently, I
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`completed senior house officer posts at the Hammersmith Hospital, the Brompton Hospital, and
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`the National Hospital for Nervous Diseases. I then completed registrar training in cardiology at
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`St. Thomas’ Hospital and the London Chest Hospital, before taking up a British Heart
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`Foundation Junior Research Fellowship at the Royal Brompton Hospital. I was also a visiting
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`fellow at Johns Hopkins Hospital, Baltimore, before becoming a Consultant Cardiologist and
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`Honorary Senior Lecturer at St. George’s in 1996. I am now Professor of Cardiology and Chief
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`of Cardiology Clinical Academic Group at St. George’s University Hospitals.
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`4.
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`5.
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`My full qualifications are set forth in my CV, attached hereto at Exhibit A.
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`I have proctored over 600 TAVR procedures in which I assist and teach other
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`physicians how to perform TAVR. I have been and remain a Global proctor for Medtronic since
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`2010 at approximately 80 centers worldwide, including over 50 medical centers in the USA for
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`the US Pivotal Trial of the Corevalve product. I have also proctored the TAVR procedure in the
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`UK, Denmark, Belgium, Japan, India, Israel, Holland, Austria, Greece, and South Korea.
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`6.
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`I have performed TAVR procedures with Medtronic’s Corevalve and Evolut R
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`products, as well as Boston Scientific’s Lotus product and Edwards’s Sapien products.
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`7.
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`I have been active in the field of TAVR as a clinician, researcher, teacher, and
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`innovator, and I have performed over 1,000 percutaneous TAVR procedures since 2007.
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`8.
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`I have been a practicing cardiologist since 1996 and I am aware of the
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`technological advances since then.
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`Page 2
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 2 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 3 of 10 PageID #: 3038
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`9.
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`I am a named inventor on one patent, describing a specific TAVR guidewire,
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`acquired by Medtronic, and two patent applications, one for a transcatheter mitral valve, and one
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`for a novel temporary pacing wire.
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`10.
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`I am a Fellow of the Royal College of Physicians, the European Society of
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`Cardiology, the American College of Cardiology, the British Cardiovascular Society, and the
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`British Cardiovascular Intervention Society.
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`11.
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`I am the author or co-author of four books, 16 book chapters, and more than 100
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`peer-reviewed articles.
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`12.
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`For my time, I am being compensated at $800 per hour, my standard rate for this
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`type of consulting activity. My compensation is in no way contingent on the results of these or
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`any other legal proceedings.
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`Opinions Regarding Dr. Buller’s Declaration And The ‘608 Patent
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`13.
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`I have reviewed U.S. Patent No. 8,992,608 (the “‘608 patent”), the parties’ claim
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`construction briefs, and Dr. Buller’s declaration regarding the ‘608 patent. I provide the
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`following opinions regarding these materials.
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`14.
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`In Paragraph 27 of Dr. Buller’s declaration, he sets out his instructions regarding
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`the interpretation of claim terms in a patent. (Buller ¶ 27.) I have followed these same
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`instructions in coming to my opinions in this Declaration.
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`15.
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`In Paragraph 28 of Dr. Buller’s declaration, he sets out his instructions regarding
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`the standard of evaluating whether a patent claim is indefinite. (Buller ¶ 28.) I have followed
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`these same instructions in coming to my opinions in this Declaration.
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`16.
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`In Paragraph 31 of Dr. Buller’s declaration, he opines that a person of ordinary
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`skill in the art would have been an “interventional cardiologist with a working knowledge of
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`Page 3
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 3 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 4 of 10 PageID #: 3039
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`heart valve designs and endovascular prostheses, including expandable stents, stent-grafts, and
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`transcatheter heart valves, including transcatheter aortic heart valves. This person of ordinary
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`skill in the art would, where necessary, work as a team in combination with a medical device
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`engineer to fabricate a THV device.” (Buller ¶ 31.) I agree generally with this definition,
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`however, it is my opinion that a person of ordinary skill in the art could also include a cardiac
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`surgeon with experience implanting aortic valve prosthesis in the heart.
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`17.
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`Dr. Buller asserts that “wrinkling or pleating can involve several variables. In my
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`opinion, three of those variables are particularly important for purposes of determining whether
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`the phrases ‘flaps’ and ‘pockets’ as used in the ’608 patent inform, with reasonable certainty,
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`those skilled in the art about the scope of the invention: magnitude, orientation, and
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`formation.” (Buller ¶ 49.) I disagree that any of these “variables” need to be known in advance
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`or quantified in order to determine whether a device has “flaps” or “pockets” within the meaning
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`of the claims of the ‘608 patent. The word “flaps” in the claim and in the context of the
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`description in the specification is clear and means fabric that projects from the anchor. To
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`determine whether a device has “flaps” or “pockets,” it is not necessary to determine whether the
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`fabric projects a little or a lot, whether it is oriented in a certain direction, or how the fabric flap
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`is formed. Instead, the fabric simply needs to project from the anchor in order to form flaps.
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`Of course, the claim also requires the fabric flaps to (i) be part of a fabric seal and (ii) extend into
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`the gaps formed by the native valve leaflets.
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`18.
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`Dr. Buller describes several pieces of prior art that show what he considers to be
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`flaps and pockets. The stent graft shown in paragraph 45 of Dr. Buller’s declaration (the EVT
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`endograft) does not appear to have flaps or pockets that project away from the anchor.
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`(Buller ¶ 45.) To be sure, there are wrinkles shown in the left-most diagram of paragraph 45, but
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`Page 4
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 4 of 59
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`it is not clear whether the wrinkles extend inwardly into the holes between the anchor’s struts or
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`whether they project away from the anchor. Regardless, persons of ordinary skill in the art
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`would not have considered the covering around an endograft like the EVT endograft to have
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`been suitable as a fabric seal in highly diseased and calcified locations, such as in a diseased
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`aortic annulus. The covering around the EVT endograft shown in Dr. Buller’s declaration does
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`not form flaps and pockets that would extend into the gaps form by native aortic valve leaflets.
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`19.
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`Dr. Buller points to several other pieces of prior art that he contends show “flaps
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`and pockets” (Buller ¶¶ 46-48), but I do not believe this is relevant to the question of whether the
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`terms “flaps” and “pockets” in the ‘608 patent are indefinite. I have not yet considered whether
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`the prior art shows “flaps” and “pockets.”
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`20.
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`Dr. Buller provides three specific bases for his opinion that the term “flaps” is
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`indefinite: he asserts that a person of ordinary skill in the art would not know the magnitude,
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`orientation, and formation of the claimed “flaps.” (Buller ¶ 49.) I disagree.
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`21.
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`First, Dr. Buller asserts that “[a]ny fabric covering with wrinkles, for example,
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`could be said to have portions that project from the anchor slightly along the wrinkles. Even
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`very smooth fabric seals could project from the anchor at least in those areas along the open cells
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`of the anchor due to the crimping process and the subsequent expansion of the valve, much like
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`the wrinkles that form in clothing. The person of ordinary skill is thus left to guess whether any
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`not-smooth portions of the fabric constitute ‘flaps.’” (Buller ¶ 50.) I disagree with Dr. Buller’s
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`suggestion that a flap must project from the anchor by a predetermined distance in order to be a
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`flap. The claims of the ‘608 patent require that the flaps be part of a “fabric seal,” and, therefore,
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`they are designed to “seal” the spaces between the anchor and the native aortic annulus.
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`Additionally, the claims require that the flaps extend into the gaps formed by the native valve
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`Page 5
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 5 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 6 of 10 PageID #: 3041
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`leaflets. Persons of ordinary skill in the art at the relevant time would have known generally that
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`such gaps are on the order of millimeters and, therefore, they would expect the flaps to be on that
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`order of magnitude in size as a general matter. However, these gaps vary from patient to patient
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`and there could be a patient in which the gaps were very small and only a “wrinkle” in the fabric
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`would suffice to extend into the gap.
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`22.
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`Thus, Dr. Buller’s assertion that “[a]ny fabric covering with wrinkles” might form
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`flaps could be true as a structural matter if the fabric has portions that project away from the
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`anchor. (Buller ¶ 50.) However, in order to satisfy the rest of the claim, these “wrinkles” would
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`also have to extend into the gaps formed by the native valve leaflets. This surrounding claim
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`language combined with the knowledge of a person of ordinary skill, who would know generally
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`the size of the gaps that need to be sealed by the flaps (generally millimeters), provides an
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`objective guide for determining whether the fabric projecting from the anchor would form
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`“flaps” that meet the other requirements of the claims of the ‘608 patent.
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`23.
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`I disagree with Dr. Buller’s opinion that the ’608 patent provides “no guidance
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`regarding when a fabric covering that is not completely smooth can be said to comprise ‘flaps.’”
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`(Buller ¶ 50.) I do not see any requirement in the claims or the specification of the ‘608 patent
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`that the flaps must project away from the anchor by a certain, required distance that is known in
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`advance. Yet, Dr. Buller appears to assume this as a premise and then formulate his opinion
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`based on that premise. In order to form flaps, a fabric seal that is not completely smooth must
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`have portions that project away from the anchor—this is a clear definition that a person of
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`ordinary skill could readily apply to determine whether a device satisfies this claim element.
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`24.
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`Regardless, however, the magnitude of the “flaps” in the claimed invention would
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`generally be known by persons of ordinary skill. The specification and surrounding claim
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`Page 6
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 6 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 7 of 10 PageID #: 3042
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`language provides objective guidance as to the size of the flaps; they would be large enough to
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`extend into the gaps formed by the native valve leaflets in order to form a seal. Generally, the
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`aortic annulus is 20-25 millimeters in diameter. A person of ordinary skill in the art would know
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`generally that the gaps between the device and the native valve leaflets would be on the order of
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`a few millimeters. Some patients may have gaps up to 5 millimeters and some patients may have
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`very small gaps of less than a millimeter, but generally the gaps would be around a millimeter or
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`two and the vast majority of patients would have gaps within the range of about 0.1 millimeters
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`to about 5 millimeters.
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`25.
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`Dr. Buller relatedly opines that “[e]ven very smooth fabric seals could project
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`from the anchor at least in those areas along the open cells of the anchor due to the crimping
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`process and the subsequent expansion of the valve, much like the wrinkles that form in clothing.
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`The person of ordinary skill is thus left to guess whether any not-smooth portions of the fabric
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`constitute ‘flaps.’” (Buller ¶ 50.) I disagree. While it is true that some seals could project from
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`the anchor by only a small amount (due, for example, to the crimping process and subsequent
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`expansion of the valve) and form wrinkles like those in clothing, these wrinkles would be
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`considered “flaps” if they project away from the anchor. These flaps, however, would also have
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`to extend into the gaps formed by native valve leaflets in order to satisfy the rest of the claim
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`elements of the ‘608 patent.
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`26.
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`Second, Dr. Buller’s opinion that the orientation of the flaps supports
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`indefiniteness is itself unclear. He argues that circumferentially-oriented flaps (i.e., flaps going
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`around the device) tend to provide a seal and that longitudinally-oriented flaps (i.e., flaps running
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`along the length of the device) tend not to provide a seal. (Buller ¶ 51.) I disagree with his
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`assumption that longitudinally-oriented flaps would tend not to provide a seal; such a flap could
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`Page 7
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 7 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 8 of 10 PageID #: 3043
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`seal a longitudinally-oriented gap between the device and surrounding tissue. In any event, Dr.
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`Buller’s conclusion that “[i]f ‘flaps’ as claimed can broadly include structures that promote
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`rather than prevent leaks, the claims fail to inform, with reasonable certainty, those skilled in the
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`art about the scope of the invention,” does not logically follow. (Buller ¶ 50.) The issue here is
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`whether the term “flaps” is indefinite and in my opinion it is not—it is fabric that projects from
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`the anchor. The orientation of the flaps generally takes the form of the gaps between the device
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`and the anatomy, which varies from patient to patient. In fact, the orientation of these gaps can
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`vary even within a single patient’s aortic annulus, which is an irregularly-shaped site of disease.
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`The specification provides that the fabric seal “bunches up” to form flaps and pockets that extend
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`into the gaps formed by native valve leaflets. Thus, the flaps and pockets may have any
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`orientation, and a person of ordinary skill in the art would have well known this.
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`27.
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`Third, Dr. Buller appears to opine that the ‘608 patent does not specify how the
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`flaps and pockets are formed in the seal. (Buller ¶ 54.) He asks rhetorically, “[m]ust the flaps be
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`created as part of the transition between a smooth undeployed state and the deployed state?”
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`(Id.) I do not see any requirements in the claim regarding how the flaps are formed. Rather, the
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`claim simply requires that they be present when in the deployed state. A person of ordinary skill
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`can ascertain objectively and with reasonable certainty whether a fabric seal around a device like
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`that claimed in the ‘608 patent has flaps in the deployed state—they would ask whether the
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`fabric projects away from the anchor. For pockets, they would look to see if the fabric seal has
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`cavities. A person of ordinary skill would not need to know how the flaps and pockets were
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`formed in order to determine if they are present. Thus, it seems to me irrelevant whether “the
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`person of ordinary skill cannot use formation as a guide in order to determine whether the outer
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`covering is within the scope of the invention,” as Dr. Buller opines. (Id.)
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`Page 8
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 8 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 9 of 10 PageID #: 3044
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`28.
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`Dr. Buller reiterates his opinions about flaps with respect to pockets, as do I.
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`(Buller ¶ 55.) He notes that “a person of ordinary skill in the art, would not be able to determine
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`with reasonable certainty the boundary of what constitutes a ‘pocket’ based on the disclosures of
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`the ’608 patent” due to the “lack of guidance regarding the magnitude of the claimed ‘pockets.’”
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`(Id.) For the reasons stated above, I disagree. The claims do not specify a magnitude for the
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`claimed pockets; they could be any magnitude that extends into the native valve leaflets to form
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`a seal. And, in fact, a person of ordinary skill would generally know that this magnitude would
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`be on the order of one to two millimeters and between 0.1 and 5 millimeters for the vast majority
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`of patients.
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`29.
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`Dr. Buller’s opinion that the term “pockets” is indefinite because they could
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`appear in many places on the device (Buller ¶ 56) is also irrelevant to the question at hand.
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`Dr. Buller’s discussion of cavities that extend into the stent do not apply here because the claims
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`of the ‘608 patent recite flaps and pockets that extend into the gaps formed by native valve
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`leaflets to provide a seal. A person of ordinary skill would know objectively and with reasonable
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`certainty whether a fabric seal formed such cavities.
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`I declare under penalty of perjury under the laws of the United States of America that the
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`foregoing is true and correct.
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`Executed this 1st day of March, 2017.
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`Stephen J.D. Brecker, MD, FACC.
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`Page 9
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 9 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109 Filed 03/01/17 Page 10 of 10 PageID #: 3045
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`
`CERTIFICATE OF SERVICE
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`I, Karen L. Pascale, Esquire, hereby certify that on March 1, 2017, I caused to be
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`electronically filed a true and correct copy of the foregoing document with the Clerk of the Court
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`using CM/ECF (which will send notification that such filing is available for viewing and
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`downloading to all registered counsel), and in addition caused true and correct copies of the
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`foregoing document to be served upon the following counsel of record by e-mail:
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`For Defendant, Edwards Lifesciences Corporation:
`
`Jack B. Blumenfeld
`Brian P. Egan
`Megan E. Dellinger
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`1201 North Market Street
`P.O. Box 1347
`Wilmington, DE 19899-1347
`
`Nicholas P. Groombridge
`Kira A. Davis
`Catherine Nyarady
`William O’Hare
`Jenny C. Wu
`PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP
`1285 Avenue of the Americas
`New York, NY 10019-6064
`
`jblumenfeld@mnat.com
`began@mnat.com
`mdellinger@mnat.com
`
`ngroombridge@paulweiss.com
`kdavis@paulweiss.com
`cnyarady@paulweiss.com
`wohare@paulweiss.com
`jcwu@paulweiss.com
`
`
`
`
`March 1, 2017
`
`
`
`
`
`
`
`01:18654113.1
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`
`
`
`YOUNG CONAWAY STARGATT & TAYLOR, LLP
`/s/ Karen L. Pascale
`
`Karen L. Pascale (#2903) [kpascale@ycst.com]
`Pilar G. Kraman (#5199) [pkraman@ycst.com]
`Rodney Square
`1000 North King Street
`Wilmington, DE 19801
`Telephone: (302) 571-6600
`Attorneys for Plaintiffs/Counterclaim Defendants
`Boston Scientific Corporation and Boston Scientific
`Scimed, Inc., and Third-Party Defendant Sadra
`Medical, Inc.
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 10 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109-1 Filed 03/01/17 Page 1 of 49 PageID #: 3046
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`EXHIBIT A
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 11 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109-1 Filed 03/01/17 Page 2 of 49 PageID #: 3047
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`ADDRESS :
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`NATIONALITY :
`DATE OF BIRTH :
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`GENERAL EDUCATION
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`1973-1978
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`UNDERGRADUATE EDUCATION
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`1978-1984
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`QUALIFICATIONS
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`1981
`1984
`1987
`1993
`1999
`1999
`2000
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`M.D. THESIS
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`APPOINTMENTS
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`C U R R I C U L U M V I T A E
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`STEPHEN JON DAVID BRECKER
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`St. George’s Hospital, Blackshaw Road, London SW17 0QT
`Telephone : +44-(0)20-8725-3556
`
`Fax : +44-(0)20-8725-0211
`email : sbrecker@sgul.ac.uk
`British
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`30th April 1960
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`University College School, London NW3
`9 GCE 'O' Levels
`3 GCE 'A' Levels & 1 GCE 'S' Level with Distinction
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`St. Thomas' Hospital Medical School
`University of London
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`BSc (Hons 2,i) Pharmacology and Basic Medical Sciences
`MB, BS with Distinction
`MRCP (UK)
`MD
`FESC
`FACC
`FRCP
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`Systolic and Diastolic Interactions in Ventricular Disease
`University of London : 1993
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`Chief of Cardiology
`St. George's University Hospitals NHS Foundation Trust
`St. George's University of London
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`Consultant Cardiologist,
`St. George's Hospital, London
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`Reader in Structural Heart Disease,
`St. George's, University of London
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`1
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 12 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109-1 Filed 03/01/17 Page 3 of 49 PageID #: 3048
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`2005-2006 : Clinical Lead, South West London Cardiac Network
`2005-2010 : Director of Cardiac Catheterisation Laboratories
`2006-2010 : Care Group Lead - Cardiology
`Recognised Teacher of the University of London
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`APPOINTMENTS
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`HONOURS, AWARDS AND PRIZES
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`1980
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`1981
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`1982
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`1983
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`1983
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`1984
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`1990
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`1991
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`1992
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`Grainger Testimonial Prize in Pharmacology
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`Medical Research Council BSc Scholarship
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`Lord Riddell Surgical Prize - Proxime accessit
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`Second Charles Box Medical Prize (Clinical Medicine)
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`Gladstone, Stansfield, Stewart Memorial Bursary
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`Distinction in Pathology (London Part IV MB,BS)
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`British Heart Foundation Junior Research Fellowship
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`E. Merck Travelling Scholarship
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`1st Runner Up, Rhône-Poulenc Rorer / Junior Cardiac Club Travelling
`Scholarship - Investigators Awards
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`2000
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`South Thames Department of Postgraduate Medical & Dental Education,
`University of London
`Certificate in Teaching
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`2
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 13 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109-1 Filed 03/01/17 Page 4 of 49 PageID #: 3049
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`PREVIOUS APPOINTMENTS
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`April 1994 -
`April 1996
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`April 1993 -
`April 1994
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`Clinical Lecturer and Honorary Senior Registrar in Cardiology
`The London Chest Hospital, The Royal Hospitals NHS Trust,
`London.
`
`Waring Lecturer and Honorary Senior Registrar in Cardiology
`The Royal Brompton National Heart and Lung Hospital & The National
`Heart and Lung Institute, London.
`
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`
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`October 1990 -
`April 1993
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`May 1989 -
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`October 1990
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`November 1988 -
`May 1989
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`November 1987 -
`October 1988
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`May 1987 -
`October 1987
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`August 1986 -
`February 1987
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`February 1986 -
`July 1986
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`August 1985 -
`January 1986
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`February 1985 -
`July 1985
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`August 1984 -
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`January 1985
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`British Heart Foundation Junior Research Fellow,
`& Honorary Registrar in Cardiology,
`The Royal Brompton National Heart and Lung Hospital & The
`National Heart and Lung Institute, London.
`
`
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`Registrar in Cardiology,
`The London Chest Hospital, London.
`
`Registrar in General Medicine and Cardiology,
`St. Thomas' Hospital, London.
`
`Registrar in General Medicine,
`Kingston Hospital, Surrey.
`
`Senior House Officer in Neurology,
`The National Hospital for Nervous Diseases, Queen Square, London.
`
`Senior House Officer in Cardiology,
`Brompton Hospital, London.
`
`Senior House Officer, Intensive Therapy Unit,
`St. Thomas's Hospital, London.
`
`Senior House Officer,
`Department of Renal Medicine and Immunology,
`Hammersmith Hospital and Royal Postgraduate Medical School,
`London.
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`House Physician to The Medical Unit,
`St. Thomas's Hospital, London.
`
`House Surgeon,
`Kingston Hospital, Surrey.
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`3
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`Percutaneous Guidewire
`
`US 2012/0016342 A1
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`COURSES ORGANISED
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`Annual Transoesophageal Echocardiography Course
`March 1995 – March 1996
`The London Chest Hospital, London
`March 1997 – March 2015
`St. George’s Hospital, London
`
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`REVIEWER FOR JOURNALS
`
`Circulation, Journal of the American College of Cardiology, Heart, European Heart Journal, Lancet,
`Nature Clinical Practice Cardiovascular Medicine, American Journal of Cardiology,
`EuroIntervention, European Heart Journal Cardiovascualr Imaging, Clinical Cardiology,
`International Journal of Cardiology, Catheterization and Cardiovascular Interventions, Drug &
`Therapeutics Bulletin, European Journal of Cardiac Pacing and Electrophysiology, Journal of
`Cardiovascular Risk, Intensive Care Medicine and Thorax.
`
`
`SCIENTIFIC SESSION ABSRACT GRADER
`
`European Society of Cardiology, American College of Cardiology, Transcatheter Cardiovascular
`Therapeutics, British Cardiovascular Society.
`
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`FELLOWSHIP & MEMBERSHIP OF SOCIETIES
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`Fellow of the Royal College of Physicians
`
`Fellow of the European Society of Cardiology
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`Fellow of the American College of Cardiology
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`British Cardiovascular Society
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`British Cardiovascular Intervention Society
`
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`PATENT APPLICATIONS
`
`19.01.12
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`25.09.13
`25.09.13
`26.09.13
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`Replacement Heart Valve
`Replacement Heart Valve
`Replacement Heart Valve
`
`GB 2500432
`EP 2 641 570 A1
`US 2013/0253642 A1
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`4
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`PUBLICATIONS
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`Books
`
` A
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` Timmis, S Brecker. Diagnosis in Color. Cardiology. London. Mosby-Wolfe. 1997.
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` J Brecker, R H Anderson. The Adult Heart. London. Imperial College Press. 2000.
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` S
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` S
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` J D Brecker. Percutaneous Device Closure of the Atrial Septum. Abingdon. Informa
`Healthcare. 2006.
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` S
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` Brecker, M Rothman. Clinical Guide to Primary Angioplasty. London. Informa Healthcare.
`2010
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`Videotape and accompanying book
`
` S
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` J Brecker, R H Anderson. Echo-morphologic correlates: The adult heart. London. Imperial
`College Press. 2000.
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`Book Chapters
`
` S
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` J D Brecker, P J Oldershaw. Echocardiography. In : A Martin, A J Camm (eds). Geriatric
`Cardiology. Principles and Practice. Chichester. John Wiley & Sons Ltd. 1994, 91-129.
`
` S
`
` J D Brecker. Transoesophageal echocardiography. In : A Redington, D Shore,
`P Oldershaw (eds). Congenital Heart Disease in Adults: A Practical Guide. London.
`W. B. Saunders Company Ltd. 1994, 17-27.
`
` S
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` J D Brecker. Atrial septal defect. In : A Redington, D Shore, P Oldershaw (eds). Congenital
`Heart Disease in Adults: A Practical Guide. London. W. B. Saunders Company Ltd. 1994, 103-
`110.
`
` S
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` J D Brecker. Ventricular septal defect. In : A Redington, D Shore, P Oldershaw (eds).
`Congenital Heart Disease in Adults: A Practical Guide. London. W. B. Saunders Company Ltd.
`1994, 111-117.
`
` J D Brecker. Atrial septal defect. In : R Pounder, M Hamilton (eds). Handbook of Current
`Diagnosis & Treatment. London. Current Medicine Inc., Churchill Livingstone. 1995, 52-53.
`
` S
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` S
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` J D Brecker. Eisenmenger complex. In : R Pounder, M Hamilton (eds). Handbook of Current
`Diagnosis & Treatment. London. Current Medicine Inc., Churchill Livingstone. 1995, 124-126.
`
` S
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` J D Brecker. Heart block. In : R Pounder, M Hamilton (eds). Handbook of Current Diagnosis
`& Treatment. London. Current Medicine Inc., Churchill Livingstone. 1995, 176-178.
`
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`S J D Brecker, M T Rothman. Implant complications and management. In : U Sigwart (ed).
`Endoluminal Stenting. London. W. B. Saunders Company Ltd. 1996, 296-305.
`
` S
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` J D Brecker, M T Rothman. 1997. The Cordis coronary stent. In : P W Serruys (ed). Handbook
`of Coronary Stents. London. Martin Dunitz Ltd. 1997, 63-69.
`
` R
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` Sharma, S J Brecker. Echocardiography. In : H Purcell, A Kalra (eds). Cardiology. Edinburgh.
`Elsevier Mosby Ltd. 2005, 51-57.
`
` M
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` Hickman, S Brecker. Tips and tricks of atrial septal defect closure. In : M Sabate (ed).
`Percutaneous Cardiac Interventions. Tips and Tricks of New Techniques Beyond Stenting.
`Toulouse. PCR Publishing. 2010, 157-164.
`
`J-C Laborde, S J D Brecker. Implantation of the CoreValve aortic valve. In : J D Carroll, J G
`Webb (eds). Manual of Adult Structural Heart Disease Interventions. Philadelphia. Lippincott
`Williams & Wilkins. 2012, 267-285.
`
` W
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` H Gaasch, S J D Brecker, G S Aldea. Transcatheter aortic valve replacement. UpToDate.
`Wolters Kluwer Health 2012-4. www.uptodate.com.
`
` P
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` S Douglas, G S Bloomfield. S J D Brecker (Ed). Imaging for transcatheter aortic valve
`replacement. UpToDate. Wolters Kluwer Health 2014. www.uptodate.com.
`6
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`W H Gaasch, S J D Brecker, G S Aldea. Transcatheter aortic valve replacement: Outcomes and
`complications. UpToDate. Wolters Kluwer Health 2015. www.uptodate.com.
`
` J D Brecker, W H Gaasch, G S Aldea. Transcatheter aortic valve replacement: Indications and
`periprocedural management. UpToDate. Wolters Kluwer Health 2015. www.uptodate.com.
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 18 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109-1 Filed 03/01/17 Page 9 of 49 PageID #: 3054
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`Peer Review Editorials and Reviews
`
` S
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` J D Brecker, D G Gibson.
`Diagnosis, effects and treatment of subendocardial failure.
`Primary Cardiology 1994; 20:19-25.
`
` J
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` N Shephard, S J Brecker, T W Evans.
`Bedside assessment of myocardial performance in the critically ill.
`Intensive Care Medicine 1994; 20:513-521.
`
` S
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` J D Brecker.
`Myocardial infarction in patients with normal coronary arteries.
`Annals of Medicine 1994; 26:383-384.
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` S
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` J D Brecker.
`The leaking prosthetic valve.
`British Journal of Hospital Medicine 1996; 55:415-418.
`
` S
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` J D Brecker, D G Gibson.
`What is the role of pacing in dilated cardiomyopathy ?
`European Heart Journal 1996; 17:819-824.
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` S
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` J D Brecker, D G Gibson.
`Echocardiographic evaluation of ventricular diastolic function: implications for treatment.
`Heart 1996; 76:386-387.
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` T
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` Treasure, S J D Brecker.
`The role of echocardiography in the diagnosis of aortic dissection.
`The Journal of Heart Valve Disease 1996; 5:623-629.
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` S
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` J D Brecker.
`The managememt of unstable angina.
`Drug and Therapeutics Bulletin 1998; 36:36-39.
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` P
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` M Elliott, S J D Brecker, W J McKenna.
`Diastolic dysfunction in hypertrophic cardiomyopathy.
`European Heart Journal 1998; 19:1125-1127.
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` S
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` J D Brecker.
`Pulmonary venous flow analysis after cardioversion.
`European Heart Journal 1999; 20:323-324.
`
` S
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` J D Brecker, J R Pepper, S J Eykyn.
`Aortic root abscess.
`Heart 1999; 82:260-262.
`
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` S
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` J D Brecker.
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`Edwards Lifesciences Corporation, et al., Exhibit 1067, p. 19 of 59
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`Case 1:16-cv-00275-SLR-SRF Document 109-1 Filed 03/01/17 Page 10 of 49 PageID #:
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`The importance of long axis ventricular function.
`Heart 2000; 84:577-578.
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` R
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` H Anderson, S Y Ho, S J Brecker.
`Anatomic basis of cross-sectional echocardiography.
`Heart 2001; 85:716-720.
`
` C
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` Varma, S J D Brecker.
`Predictors of mortality in acute myocardial infarction.
`Lancet 2001; 358:1473-1474.
`
` D
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` Pellerin, S J D Brecker.
`A step further in inter-institutional agreement in interpretation of dobutamine stress
`echocardiograms.
`European Heart Journal 2002; 23:768-771.
`
` N
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` Parchure, S J D Brecker.
`Management of acute coronary syndromes.
`Current Opinion in Critical Care 2002; 8:230-235.
`
` D
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` Pellerin, S Brecker, C Veyrat.
`Degenerative mitral valve disease with emphasis on mitral valve prolapse.
`Heart 20