UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`
`Petitioner,
`
`v.
`
`ENDOHEART AG
`
`Patent Owner.
`__________________
`
`Case IPR2016-00299
`U.S. Patent No. 8,182,530
`__________________
`
`DECLARATION OF DR. JOHN R. GARRETT, M.D.
`
`
`
`Edwards Exhibit 1026, pg. 1
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`EDWARDS LIFESCIENCES CORPORATION,
`
`Petitioner,
`
`v.
`
`ENDOHEART AG
`
`Patent Owner.
`__________________
`
`Case IPR2016-00299
`U.S. Patent No. 8,182,530
`__________________
`
`DECLARATION OF DR. JOHN R. GARRETT, M.D.
`
`
`
`Edwards Exhibit 1026, pg. 1
`
`
`
`I, Dr. John R. Garrett, M.D. declare as follows:
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`I.
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`1.
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`INTRODUCTION
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`I am over the age of eighteen (18) and otherwise competent to make this
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`Declaration.
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`A. Engagement
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`2.
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`I have been retained on behalf of Edwards Lifesciences Corporation
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`(“Edwards”) to provide my opinion on the scope and content of “prior art,” that is
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`technology related, but predating the application for U.S. Patent No. 8,182,530
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`(“the ‘530 patent”), and regarding the subject matter recited in the claims of the
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`‘530 patent, in particular claims 1 and 6 of the ‘530 patent. I understand that this
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`Declaration relates to a petition for the above-captioned inter partes review (IPR)
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`of the ‘530 patent.
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`B.
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`Background and Qualifications
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`3. A detailed description of my professional qualifications, including a listing of
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`my specialties/expertise and professional activities, is contained in my curriculum
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`vitae, a copy of which is attached as Appendix A.
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`4.
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`I am currently the Chief of the Department of Cardiac, Thoracic and Vascular
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`Surgery, the Director of Physician Operations, and the Chairman of the Board of
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`Directors at the Virginia Hospital Center.
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`
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`2
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`Edwards Exhibit 1026, pg. 2
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`
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`5.
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`I earned both my M.D. and M.S. in physiology and biophysics from the
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`University of Alabama in 1979 and 1975, respectively. I received my B.S. in
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`biology from Emory University in 1972.
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`6. My postgraduate training included a residency in cardiothoracic and vascular
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`surgery at the Texas Heart Institute, where I studied under Dr. Denton Cooley, one
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`of the leading heart surgeons in the world. I became an attending surgeon in 1986
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`and by 1990 had performed approximately 500 open-chest heart valve replacement
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`surgeries. A complete listing of my postgraduate training, university service and
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`hospital appointments can be found in my curriculum vitae (see Appendix A).
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`7. My Professional Activities include the following:
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` American College of Surgeons Fellow
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` Cooley Hands Society
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` Denton A. Cooley Cardiovascular Surgical Society
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` Society of Thoracic Surgeons
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` Arlington County Medical Society
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`8.
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`I have contributed to several articles in various journals, including, but not
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`limited to:
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` Schwartz, R. L., Garrett, J. R., Karp, R. B., Kouchoukos, N. T.
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`“Simultaneous Myocardial Revascularization and Carotid
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`Endarterectomy.” Circulation, 66:I97-101 (1982).
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`
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`3
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`Edwards Exhibit 1026, pg. 3
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`
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` Cooley, D.A., Garrett, J.R. “Septoplasty for Left Ventricular Outflow
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`Obstruction Without Aortic Replacement: A New Technique.” Ann
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`Thorac Surg, 42:445-448 (1986).
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` Rhee, J.W., Garrett, J.R. “Use of a Cast Spreader During
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`Reoperative Sternotomy.” Ann Thorac Surg, 64(3):863 (1997).
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`9.
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`I have also been involved as a principal investigator in several research
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`projects, namely one related to coronary artery bypass graft (“CABG”) surgery
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`with cardiopulmonary bypass and one related to the risk of myocardial necrosis
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`during and after CABG surgery, both completed in 2002. I was also awarded a
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`research grant funded by Davis and Geck, Medical Device Division, American
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`Cyanamid to develop and evaluate small diameter vascular prostheses from 1987-
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`1989. A more complete description of the projects described above can be found in
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`my curriculum vitae (see Appendix A).
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`10. I have reviewed the ‘530 patent and its file history. I have reviewed the prior
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`art and other documents and materials cited herein. My opinions are also based in
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`part upon my education, training, research, knowledge, and experience. For ease
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`of reference, the full list of information that I have considered is included in
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`Appendix B.
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`
`
`4
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`Edwards Exhibit 1026, pg. 4
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`
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`C. Legal Standards for Patentability
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`11. A patent claim is unpatentable if the differences between the patented subject
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`matter and the prior art are such that the subject matter as a whole would have been
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`obvious at the time the invention was made to a person of ordinary skill in the art.
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`I am informed that this standard is set forth in 35 U.S.C. § 103(a).
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`12. When considering the issues of obviousness, I am to do the following: (i)
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`determine the scope and content of the prior art; (ii) ascertain the differences
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`between the prior art and the claims at issue; (iii) resolve the level of ordinary skill
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`in the pertinent art; and (iv) consider objective evidence of non-obviousness. I
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`appreciate that secondary considerations must be assessed as part of the overall
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`obviousness analysis (i.e., as opposed to analyzing the prior art, reaching a
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`tentative conclusion, and then assessing whether objective indicia alter that
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`conclusion).
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`13. Put another way, my understanding is that not all innovations are patentable.
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`Even if a claimed product or method is not explicitly described in its entirety in a
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`single prior art reference, the patent claim will still be denied if the claim would
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`have been obvious to a person of ordinary skill in the art at the time of the patent
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`application filing.
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`14. In determining whether the subject matter as a whole would have been
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`considered obvious at the time that the patent application was filed, by a person of
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`
`
`5
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`Edwards Exhibit 1026, pg. 5
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`
`
`ordinary skill in the art, I have been informed of several principles regarding the
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`combination of elements of the prior art:
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`a. First, a combination of familiar elements according to known
`methods is likely to be obvious when it yields predictable results.
`
`b. Second, if a person of ordinary skill in the art can implement a
`“predictable variation” in a prior art device, and would see the benefit
`from doing so, such a variation would be obvious. In particular, when
`there is pressure to solve a problem and there are a finite number of
`identifiable, predictable solutions, it would be reasonable for a person
`of ordinary skill to pursue those options that fall within his or her
`technical grasp. If such a process leads to the claimed invention, then
`the latter is not an innovation, but more the result of ordinary skill and
`common sense.
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`15. The “teaching, suggestion, or motivation” test is a useful guide in establishing
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`a rationale for combining elements of the prior art. This test poses the question as
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`to whether there is an explicit teaching, suggestion, or motivation in the prior art to
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`combine prior art elements in a way that realizes the claimed invention. Though
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`useful to the obviousness inquiry, I understand that this test should not be treated as
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`a rigid rule. It is not necessary to seek out precise teachings; it is permissible to
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`consider the inferences and creative steps that a person of ordinary skill in the art
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`(who is considered to have an ordinary level of creativity and is not an
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`“automaton”) would employ.
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`
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`6
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`Edwards Exhibit 1026, pg. 6
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`
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`II. DESCRIPTION OF THE RELEVANT FIELD AND THE RELEVANT
`TIMEFRAME
`16. I have carefully reviewed the ‘530 patent.1
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`17. I understand that the ‘530 patent issued from U.S. Patent Application No.
`
`11/023,783, which was filed on December 28, 2004. I also understand that U.S.
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`Patent Application No. 11/023,783 claims the benefit of priority to provisional U.S.
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`Patent Application No. 60/615,009, filed on October 2, 2004.2
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`18. It is my understanding that the earliest possible effective filing date of the ‘530
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`patent is the filing date of provisional U.S. Patent Application No. 60/615,009,
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`which is October 2, 2004. However, as discussed in greater detail below in Section
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`VII, I am of the opinion that the claims at issue should not be entitled to the earliest
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`possible effective filing date.
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`19. Based on my review of this material, I believe that the relevant field for the
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`purposes of the ‘530 patent is the repair and replacement of heart valves, such as
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`aortic valves.
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`III. THE PERSON OF ORDINARY SKILL IN THE RELEVANT FIELD
`IN THE RELEVANT TIMEFRAME
`20. I have been informed that “a person of ordinary skill in the relevant field” is a
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`hypothetical person to whom an expert in the relevant field could assign a routine
`
`
`1 See Ex. 1001.
`2 See Ex. 1003.
`
`
`
`7
`
`Edwards Exhibit 1026, pg. 7
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`
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`task with reasonable confidence that the task would be successfully carried out. I
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`have been informed that the level of skill in the art is evidenced by prior art
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`references. The prior art discussed herein demonstrates that a person of ordinary
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`skill in the field, at the time the ‘530 patent was effectively filed, would have
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`possessed good working skills as either an interventional cardiologist or a
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`cardiac/cardiothoracic surgeon having knowledge of and experience with
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`guidewire technology or otherwise working with a person having knowledge of
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`and experience with guidewire technology.
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`21. Based on my experience, I have an understanding of the capabilities of a
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`person of ordinary skill in the relevant field. I am a cardiothoracic surgeon with 25
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`plus years of experience, having knowledge of and personal experience with
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`guidewire technology. I am trained and skilled in resecting, repairing and
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`replacing heart valves and blood vessels that have sustained damage from disease
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`or injury. Further, I am experienced in being able to identify and quickly respond
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`to medical emergencies both during and after surgical procedures. Besides, I had
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`those capabilities myself at the time the patent was effectively filed.
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`IV. TECHNICAL BACKGROUND AND STATE OF THE ART AS OF 2004
`22. I have reviewed and endorse as set forth fully herein Section II of the
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`accompanying petition, titled “STATE OF THE ART IN THE 2003 TO 2004 TIME
`
`FRAME.” I provide additional insight as to the technological developments in the
`8
`
`
`
`Edwards Exhibit 1026, pg. 8
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`
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`field of cardiology in the 2003 to 2004 time frame, specifically, with respect to
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`treating valvular heart disease.
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`23. Conventionally, valvular heart disease was treated with a major open-heart
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`surgical procedure, requiring a full sternotomy and cardiopulmonary bypass for
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`repairing or replacing the heart valve on a non-beating heart. Such surgical
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`intervention, however, was quite risky, especially for the elderly. That is, older
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`patients typically have a higher risk of stroke due to atherosclerotic arteries and are
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`slower to heal and mobilize following cardiac surgery. Additionally, there is a risk
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`of organ failure due to unpredictable blood flows while on cardiopulmonary
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`bypass. Further, some elderly patients have completely calcified aortas, preventing
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`surgical access. Unfortunately, the risks of not intervening were significant and
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`outweighed the risks of the invasive surgical procedure.
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`24. Accordingly, considerable efforts were devoted to developing less invasive
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`means for treating diseased valves, such as endovascular surgical techniques. For
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`example, a balloon aortic valvuloplasty was first performed by Cribier in 1985.3
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`Although initial results were good and attracted attention, the data proved the
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`procedure to be unsafe and the relief temporary.4
`
`
`3 Cribier, Alain, et al. “Percutaneous Transluminal Valvuloplasty of Acquired Aortic Stenosis in
`Elderly Patients: An Alternative to Valve Replacement? Lancet, 1:63-67 (1986). (Ex. 1028)
`4 McKay, Raymond, G., et al. “The Mansfield Scientific Aortic Valvuloplasty Registry:
`Overview of Acute Hemodynamic Results and Procedural Complications.” JACC, 17(2):485-491
`
`
`
`9
`
`Edwards Exhibit 1026, pg. 9
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`
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`25. Then, in 1992, Dr. Andersen published an article directed to a new artificial
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`aortic valve prosthesis developed for implantation by a transluminal catheter
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`technique in animals, without thoracotomy or extracorporal circulation.5 In
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`particular, a porcine aortic valve was mounted into an expandable stent, with the
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`stent-valve then mounted on a balloon catheter, which was advanced to the
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`ascending aorta via a retrograde approach.6
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`26. At the turn of the century, in 2000, Cribier reported another procedure
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`involving the implantation of a percutaneous heart valve.7 The device was
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`successfully implanted in a sheep. However, percutaneous placement of artificial
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`heart valves had drawbacks in terms of having to perform the entire procedure
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`using smaller diameter vessels, limiting the use of larger tool and devices for
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`treating the diseased valves.
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`27. Two years later, in 2002, Cribier implanted the first transcatheter aortic valve
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`replacement in a 57 year old patient, who was otherwise inoperable after his
`
`
`(1991). (Ex. 1029); Bashore, Thomas, M., et al. “Follow-up Recatherization After Balloon Aortic
`Valvuloplasty.” JACC, 17(5):1188-1195 (1991). (Ex. 1030)
`5 Ex. 1007, Abstract.
`6 Id.
`7 Cribier, Alain, et al. “Trans-Catheter Implantation of Balloon-Expandable Prosthetic Heart
`Valves: Early Results in an Animal Model.” Circulation, 104(17), II-552:2609 (2001). (Ex.
`1031)
`
`
`
`10
`
`Edwards Exhibit 1026, pg. 10
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`
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`condition deteriorated following a balloon valvuloplasty.8 In order to implant the
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`percutaneous heart valve Cribier followed an antegrade approach from the right
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`femoral vein. A guidewire was advanced across the stenotic aortic valve through a
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`balloon flotation catheter. In particular, the percutaneous heart valve was crimped
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`over the balloon catheter, advanced through the sheath, across the interatrial
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`septum, and within the diseased stenotic aortic valve.9 Although the patient died
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`four months later, the valve prosthesis demonstrated excellent hemodynamic
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`performance during the first nine weeks of follow-up.
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`28. The following year, in 2003, Zhou reported an off-bypass implantation of a
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`self-expandable valved stent in the pulmonary valve position.10 After making a
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`short incision on the anterior aspect of the right ventricle to access the heart, a
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`stent-graft delivery system was advanced in the antegrade direction to the
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`pulmonary valve position.11 As understood by skilled artisans performing similar
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`procedures around the timeframe of Zhou’s procedure, the tool commonly used to
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`access the valves being replaced or repaired was a guidewire. In fact, I have
`
`
`8 See Ex. 1009.
`9 Id. at 3007.
`10 See Ex. 1011.
`11 Id. at 213.
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`
`
`11
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`Edwards Exhibit 1026, pg. 11
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`
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`reviewed Zhou’s thesis, which confirms that Zhou’s trans-ventricular approach
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`used a guidewire for replacing the pulmonary valve.12
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`29. Likewise, the same year a patent application was published in July of 2003,
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`directed to treating patients diagnosed with congestive heart failure.13 Lattouf was
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`generally directed to gaining access to a patient’s heart chamber through the wall
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`of the patient’s heart, such as the apex, to repair damaged or incompetent heart
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`valves.14 One of the procedures the sole inventor, Lattouf, disclosed involved
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`“providing a valved passageway through the patient's left ventricular wall at the
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`apex of the patient's heart and advancing instruments through the valved
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`passageway [following a retrograde approach] to connect the valve leaflets of the
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`patient's heart valve, e.g. the mitral valve.”15 Lattouf also disclosed another
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`procedure, discussed in greater detail below, which was performed via an
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`antegrade, transapical approach, that involved aortic stenting for aortic dissections
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`and aneurysm therapy.16 Hence, by the year 2004, heart valves, such as the aortic
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`valve, had been implanted or repaired following both an antegrade and retrograde
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`approach, without the need for full cardiopulmonary support. In particular, it was
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`12 Zhou, Junqing. “Chirurgie Valvulaire Par Voie Endovasculaire.” Thesis (2003) (“Zhou’s
`Thesis”). (Ex. 1032)
`13 See Ex. 1005.
`14 Id. at ¶ [0007].
`15 Id. at Abstract.
`16 Id. at ¶¶ [0008], [0010].
`
`
`
`12
`
`Edwards Exhibit 1026, pg. 12
`
`
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`standard practice to replace aortic valves, as opposed to repairing the valve,
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`because such valves were not typically amenable to a lasting repair due to severe
`
`calcification of the leaflets. Most aortic valves were replaced by either a metal-
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`based (St. Jude)17 or tissue-based (Carpentier-Edwards)18 prosthesis. Mitral valves,
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`on the other hand, were usually repaired by removing a portion of the leaking valve
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`and reinforcing the valve structure with a ring sewn into the base or annulus of the
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`valve. In the event the mitral valve was stenotic, defined as having a valve area of
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`1 cm sq., replacement of the valve would be required.
`
`30. Further, in 2004, it was standard practice to access the heart using an off-the-
`
`shelf guidewire assembly, for guiding the catheter to its desired location. In a
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`typical procedure, the Seldinger technique is used for introducing the guiding
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`catheter. Next, a long wire is selected from stock on shelf and advanced through
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`the guiding catheter until the distal tip of the wire extends beyond the point where
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`the procedure is to be performed. The proximal portion of the long wire is outside
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`the patient. The catheter is advanced over the guidewire, while the position of the
`
`
`17 Gott, Vincent L., et al. “Mechanical Heart Valves: 50 Years of Evolution.” Ann Thorac Surg,
`76:S2230-2239 (2003). (Ex. 1034)
`18 McClure, Scott R., et al. “Late Outcomes for Aortic Valve Replacement with the Carpentier-
`Edwards Pericardial Bioprosthesis: Up to 17-Year Follow-Up in 1,000 Patients.” Ann Thorac
`Surg, 89:1410-1416 (2010). (Ex. 1035)
`
`
`
`13
`
`Edwards Exhibit 1026, pg. 13
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`
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`guidewire remains fixed until the operating catheter is positioned precisely where
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`desired.
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`31. Guidewires come in many different variations, e.g., differing sizes differing
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`degrees of flexibility, etc. In particular, I have reviewed a textbook on guidewires
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`which explicitly states “[b]asic construction affects handling characteristics and
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`makes each guidewire unique. Guidewires differ with respect to length, diameter,
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`stiffness, coating, tip shape, and special features.”19 The table below shows, for
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`example, how the general stiffness of the guidewire can vary based on the type of
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`used20:
`
`
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`32. Guidewires are usually selected on the basis of a lesion’s appearance, which is
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`visualized with ateriography prior to the start of the procedure. The textbook on
`
`
`19 Schneider, Peter A., ENDOVASCULAR SKILLS. GUIDEWIRE AND CATHETER SKILLS FOR
`ENDOVASCULAR SURGERY 34 (2nd ed. 2003). (Ex. 1036)
`20 Kaufman, John A., et al. VASCULAR & INTERVENTIONAL RADIOLOGY. THE REQUISITES. 35
`(2004). (Ex. 1042)
`
`
`
`14
`
`Edwards Exhibit 1026, pg. 14
`
`
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`guidewires discussed above has another chapter entitled “Crossing Stenoses”,
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`which discusses known uses for guidewires available in 2004. For example, “[a]
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`steel body, floppy-tip starting guidewire is satisfactory for many routine cases. If
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`the lesion is complex, a hydrophilic-coated guidewire is a good choice. When the
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`lesion also contains a critical stenosis, a steerable tip may be used.”21 Guidewires
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`typically have leading tips that are highly flexible, used for navigating through the
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`vessel without damaging it. The wire portion beyond the tip gradually becomes
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`increasingly stiff for better supporting the catheter. A critical feature for
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`guidewires is that they have sufficient columnar strength to be pushed through a
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`patient’s vascular system or other body lumen without buckling, while at the same
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`time maintaining flexibility in order to avoid damaging the vessel or body lumen
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`through which they are advanced. “Direct incremental advancement of a floppy-
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`tip guidewire results in passage across most lesions. If passage is unsuccessful, the
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`guidewire should not be forced.”22
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`33. As understood by persons of ordinary skill in the art, it was common to use
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`multiple types of guidewires during a single procedure, starting, for example, with
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`a floppy or flexible guidewire and then replacing it with a stiffer guidewire as the
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`procedure progressed. As an example, in Cribier’s procedure: “[a]fter standard
`
`
`21 Ex. 1036 at 119.
`22 Id. at 120.
`
`
`
`15
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`Edwards Exhibit 1026, pg. 15
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`
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`transseptal catherization, a straight 0.035-inch guidewire was advanced across the
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`stenotic aortic valve through a balloon flotation catheter. After advancement of the
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`balloon catheter into the descending aorta, the guidewire was exchanged for a stiff
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`260-cm-long guidewire.”23
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`34. By the year 2004, several different access points, such as the transfemoral,
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`transseptal and transapical, were known for accessing the heart. Beginning with
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`the transfemoral approach, a standard, well-known approach, the femoral artery in
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`the groin was typically punctured with a large needle and pulsatile flow therefrom
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`was observed in order to determine whether the needle was in the lumen of the
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`artery. Next, a wire was threaded through the needle and into the artery, and the
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`needle was withdrawn leaving only the wire inside the artery, as discussed above
`
`with respect to the Seldinger technique. Catheters could then be threaded over the
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`wire and advanced in the retrograde direction toward their desired location using
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`fluoroscopic guidance. The presence of atherosclerotic disease often complicated
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`such approach, as dislodging the plaque using the wire or catheter could cause
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`bleeding, arterial dissection, organ damage or stroke. The transfemoral approach
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`was used in 2004 for several different procedures, including balloon valvuloplasty
`
`
`23 Ex. 1009 at 3007.
`
`
`
`16
`
`Edwards Exhibit 1026, pg. 16
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`
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`and stent implantation, and diagnostic purposes, e.g., diagnosing coronary
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`blockages.24
`
`35. Another approach to the heart which predated the retrograde, transfemoral
`
`approach was the antegrade, transseptal approach through the right side or venous
`
`side of the heart. The transseptal approach was primarily used in the 1960s and
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`1970s for diagnostic cardiac procedures, such as obtaining pressures from inside of
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`the heart. Using the Seldinger technique discussed above, a wire was introduced
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`into the central venous system and a catheter was fed over it and positioned in the
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`right atrium. Next, a specialized catheter was advanced through the septal wall,
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`entering the left atrium, and following the antegrade approach to access the aortic
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`and mitral valves.25
`
`36. The antegrade, transapical approach was a common, workable alternative
`
`route for accessing the heart when stenosis or other anatomical constraints
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`precluded access through the femoral arteries or septum. The apex is a blunt tip
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`representing primarily the left ventricle and entry using the Seldinger technique is
`
`possible. Bergheim discusses the “unique anatomical structure of the apical area”
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`which permits the “greater flexibility with respect to the types of devices and
`
`
`24 See, for example, Ex. 1007.
`25 See, for example, Ex. 1009.
`
`
`
`17
`
`Edwards Exhibit 1026, pg. 17
`
`
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`surgical methods that may be performed in the heart and great vessels.”26
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`Typically, tools with larger diameters can be advanced through the apical area,
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`which is significantly larger than, for example, the femoral vessels.
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`37. Accordingly, it is my opinion that, as of 2004, a person of ordinary skill in the
`
`art would have understood that it would be obvious to implant or repair a heart
`
`valve, such as an aortic heart valve, via a transapical approach, in the event
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`stenosis or other anatomical constraints precluded access through the femoral
`
`arteries or septum.
`
`38. Similar to the access device discussed in the ‘530 patent, hemostatic
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`introducers, having one-way valves to prevent back bleeding, have been used for
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`peripheral arterial and venous cannulation since the 1990s.27 Further to the access
`
`devices discussed in the Bergheim and Lattouf prior art references below, Mortier
`
`discussed ports, window and trocars being available for limiting patient trauma.28
`
`Accordingly, installing an access device in the wall of the heart was understood by
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`a person of ordinary skill in the art as a known step in the transapical approach. As
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`an alternative approach, a series of pledgeted sutures were commonly used to
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`buttress the ventricular wall against a catheter or device to effect hemostasis.
`
`
`26 Ex. 1004, ¶ [0009].
`27 Littrell, Perry K. “Hemostasis Valve.” U.S. Patent No. 5,176,652 (1993). (Ex. 1037)
`28 See Ex. 1020.
`
`
`
`18
`
`Edwards Exhibit 1026, pg. 18
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`
`
`V. OVERVIEW OF THE ‘530 PATENT
`39. Historically, repairing and/or replacing a malfunctioning heart valve was
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`achieved via a major open heart surgical procedure, requiring general anesthesia, a
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`full cardiopulmonary bypass, weeks of hospitalization and several months of
`
`rehabilitation time for the patient. With the passage of time and progress in
`
`technology, the Huber ‘530 patent discusses methods and devices for accessing,
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`resecting, repairing and/or replacing heart valves, in particular the aortic valve or
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`adjacent tissue, using a relatively small number of small incisions and without the
`
`need for full cardiopulmonary support. Huber ‘530 performs such minimally
`
`invasive procedures through the heart muscle at its left or right ventricular apex,
`
`i.e., transapically.29
`
`40. In order to gain access to the inner heart structures, such as the left
`
`ventricle 26, Huber ‘530 discloses puncturing the myocardium 40 with a
`
`cannulated needle 42 or other suitable device (see FIG. 4 of Huber ‘530 below).30
`
`Next, a guidewire 44 is fed through the needle 42 and into the left ventricle 26.
`
`The guidewire is advanced in the antegrade direction 46, through the aortic
`
`valve 20 and into the aorta 28.31 Huber ‘530 suggests that multiple guidewires
`
`may be placed to provide access for more surgical devices.32
`
`
`29 Ex. 1001, Abstract; 1:12-25.
`30 Id. at 8:64-67.
`31 Id. at 8:67 – 9:2.
`
`
`
`19
`
`Edwards Exhibit 1026, pg. 19
`
`
`
`
`
`41. Huber ‘530 further teaches placing an access device 60 with a valve 63 in the
`
`myocardium 40 as a means for providing an access port to the surgical site inside
`
`the left ventricle 26, while, at the same time, preventing the heart chamber from
`
`bleeding out.33 The access device 60 may include multiple valves arranged in
`
`series and/or parallel in order to provide added protection against leakage from the
`
`heart chamber.34 Further, the access device 60 (see FIG. 6) allows for easy and
`
`rapid insertion of tools, devices, instruments, wires, catheters and delivery systems
`
`that will enable the repair or resection of a diseased heart valve or the implantation
`
`or replacement of a new heart valve.35 As an example, a dissection repair device is
`
`inserted through the access device in order to repair an aortic dissection.36
`
`32 Ex. 1001, 9:26-42.
`33 Id. at 9:51-61.
`34 Id. at 10:17-24.
`35 Id. at 9:57-61.
`36 Id. at 5:31-33.
`
`
`
`20
`
`Edwards Exhibit 1026, pg. 20
`
`
`
`42. The Huber ‘530 patent also describes different ways the heart valve can be
`
`replaced or installed/implanted. For example, the placement of a new valve may
`
`first involve the full or partial resection of the diseased valve or cardiac structure.37
`
`Alternatively, the diseased and calcified valve can be left as is and a new valve can
`
`be implanted within and over top of the diseased valve.38 In order to do so, the
`
`valve delivery device may be designed to draw the native leaflets downward when
`
`a new valve is being implanted over top of an existing diseased valve.39 In some
`
`instances, the new valve may be a self-expanding valve that can be implanted
`
`without the use of a balloon.40 In other embodiments, the valve may be secured in
`
`place by any suitable method for anchoring tissue within the body. Radial
`
`expansion forces may be strong enough to secure valve against dislodgment.41
`
`Huber notes that the implantation process should be done quickly because there is
`
`a brief total occlusion of the aorta during the procedure.42
`
`
`37 Ex. 1001, 12:42-44.
`38 Id. at 14:41-43.
`39 Id. at 15:66 – 16:1.
`40 Id. at 16:6-7.
`41 Id. at 16:23-26.
`42 Id. at 15:61-62.
`
`
`
`21
`
`Edwards Exhibit 1026, pg. 21
`
`
`
`VI. CLAIM INTERPRETATION
`43. In proceedings before the U.S. Patent and Trademark Office, I understand that
`
`the claims of an unexpired patent are to be given their broadest reasonable
`
`interpretation (“BRI”) in view of the specification from the perspective of one
`
`skilled in the art. I have been informed that the ‘530 patent has not expired. In
`
`comparing the claims of the ‘530 patent to the known prior art, I have carefully
`
`considered the ‘530 patent and the ‘530 patent file history based upon my
`
`experience and knowledge in the relevant field. In my opinion, the broadest
`
`reasonable interpretation of the claim terms of the ‘530 patent is generally
`
`consistent with the term’s ordinary and customary meaning, as one skilled in the
`
`relevant field would understand them, subject to the terms identified below. I have
`
`reviewed and endorse as set forth fully herein Section VI.C. of the accompanying
`
`petition, titled “Claim Construction.”
`
`44. Claim 1 of the ‘530 patent uses the phrase “the feeding continuing such that
`
`the wire follows the blood flow,” which refers to the direction of feeding. Such
`
`limitation does not require the flow of blood to direct or control the feeding of the
`
`elongated wire (which, as will be discussed in greater detail below, can be
`
`contrasted with the language of claim 6 of the ‘530 patent that does require this).
`
`The recitation in claim 1 is consistent with the specification of the ‘530 patent,
`
`which is limited to disclosing a direction of introduction of the elongated wire, and
`
`
`
`22
`
`Edwards Exhibit 1026, pg. 22
`
`
`
`makes no mention of the flow of blood, itself, directing the feeding of the
`
`elongated wire.
`
`45. Accordingly, in my opinion, the broadest reasonable interpretation of this
`
`phrase “the feeding continuing such that the wire follows the blood flow” merely
`
`requires that the direction of feeding or the advancement of the elongated wire
`
`follows the direction of blood flow, without being controlled by the flow of blood.
`
`46. Claim 6 of the ‘530 patent recites, in part, “the feeding directed by the blood
`
`flow such that the wire follows the blood flow.” In the absence of any guidance
`
`from the written description of the ‘530 patent regarding how the feeding of the
`
`elongated wire is “directed by” the blood flow, the prior art provides useful insight
`
`into the ordinary and customary meaning of this phrase at the time the ‘530 patent
`
`was filed.
`
`47. Turning first to the prior art cited by Applicant, U.S. Patent No. 5,332,402 to
`
`Teitelbaum, Teitelbaum discloses a transcatheter valve replacement procedure that
`
`includes crossing the interatrial septum with a catheter and guidewire (in the
`
`antegrade direction), after which the “catheter and guidewire or catheter is then
`
`floated with blood flow out the left ventricle and into the thoracic aorta.”43
`
`
`43 Teitelbaum, George P. “Percutaneously-Inserted Cardiac Valve.” U.S. Patent No. 5,332,402
`(1994) (“Teitelbaum”), 4:64-66. (Ex. 1038)
`
`
`
`23
`
`Edwards Exhibit 1026, pg. 23
`
`
`
`48. Although it was not cited by Applicant during prosecution of the ‘530 patent,
`
`Cribie
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