`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`____________
`
`Case IPR2014-00111
`Patent 6,482,228 B1
`____________
`
`Attorney Docket No. 058888-0000018
`____________
`
`
`
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION FOR OB-
`SERVATION REGARDING CROSS-EXAMINATION OF ALEXANDER J.
`HILL, PH.D.
`
`
`
`IPR2014-00111
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`Pursuant to the Order dated April 25, 2014 (Paper 11), Petitioner submits this re-
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`sponse to Patent Owner’s Motion for Observation Pursuant to 37 C.F.R. § 42.121
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`regarding the cross-examination testimony of Alexander J. Hill, Ph.D.
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`1.
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`Response to Observation No. 1
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`Patent Owner states that Dr. Hill was not a person of ordinary skill in the art at the
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`time the ‘228 patent was filed. This observation is irrelevant because it is based on
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`the incorrect assumption that an expert’s knowledge must be gained prior to the in-
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`vention date. See Disney Enterprises, Inc. v. Kappos, 923 F.Supp.2d 788 (E.D. Va.
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`2013)(An “expert must be qualified to testify about what a person with ordinary
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`skill in the art must have understood at the time of the invention, but the expert’s
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`knowledge may have come later.”). Dr. Hill defines a person of ordinary skill as
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`having a bachelor’s degree in mechanical or biomedical engineering and direct ex-
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`perience developing heart valves. Ex. 1026 (Hill Decl.), ¶31. As to educational ex-
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`perience, Dr. Hill has M.S. and Ph.D. degrees in Biomedical Engineering, a minor
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`in Mechanical Engineering, and a B.A. in Biology. Hill Decl., ¶¶21-24; see also,
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`Hill Decl., ¶25-29 and Ex. 2236 (“Hill Tr.”), 27:4-15. As to heart valve experience,
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`over the past nine years Dr. Hill has researched and developed heart valve re-
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`placements, including percutaneous aortic valve replacements, such as those dis-
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`closed in the ‘228 patent. Hill Decl., ¶¶5-16. Dr. Hill “has personally designed and
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`tested numerous percutaneous heart valves, and have implanted valves into both
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`1
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`IPR2014-00111
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`live and isolated hearts,” conducted research and managed a group that conducts
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`research “focused on percutaneous, minimally invasive, and surgical heart valve
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`replacement and repair,” and was involved with products designed to treat the aor-
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`tic valve. Id.; see also, Hill Tr., 35:21-36:5, 38:12-41:3. Finally, Dr. Hill worked
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`with stents while a research assistant and has personally deployed stents in isolated
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`hearts. Hill Tr., 31:8-33:19.
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`2.
`
`Response to Observation No. 2
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`Patent Owner suggests that Dr. Hill’s testimony regarding placement of a prosthet-
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`ic aortic valve should be discounted because he lacks a medical degree and is not
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`involved in the direct treatment of patients with aortic stenosis. Patent Owner’s ob-
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`servation is irrelevant. With respect to medical knowledge, Dr. Hill is a Clinical
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`Assistant Professor in the Department of Surgery at the University of Minnesota
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`Medical School, an Instructor of Advanced Cardiac Anatomy & Physiology at the
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`University of Minnesota, an Instructor of advanced cardiac anatomy didactic and
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`dissection for electrophysiology and cardiology fellows, and an Instructor of Ad-
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`vanced Cardiac Anatomy & Physiology within Medtronic. Hill Decl., ¶¶10, 27-29.
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`As a Graduate Research/Teaching Assistant, Dr. Hill worked in a cardiovascular
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`research laboratory studying mammalian cardiac anatomy, physiology, and pathol-
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`ogy; and taught human physiology and advanced cardiac anatomy and physiology.
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`Hill Decl., ¶¶25-26; Hill Tr., 28:9-19. Dr. Hill has also evaluated the clinical out-
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`IPR2014-00111
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`comes of aortic valve replacements and was involved with transcatheter valve
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`products to treat aorta stenosis. Hill Tr., 35:23-36:5; 39:24-40:23.
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`3.
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`Response to Observation No. 3
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`Patent Owner states that Dr. Hill’s testimony that the sinotubular junction “could
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`be interpreted as the transition point from the aortic root to the ascending aorta”
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`contradicts his statement that the Schreck valve extends into the ascending aorta.
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`However, when Dr. Hill was asked if the sinotubular junction is the transition point
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`from the aortic root to the ascending aorta, he responded, “I think that’s one inter-
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`pretation.” Hill Tr. 62:15-25 (emphasis added); see also, Hill Tr. 156:20-161:3. Dr.
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`Hill explained that “in other descriptions, the ascending aorta includes the entirety
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`of the aortic root.” Hill Tr. 165:1-13; see also, Hill Decl., ¶¶33, 65-68, 71.
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`4.
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`Response to Observation No. 4
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`Patent Owner states that Dr. Hill’s testimony regarding the sinotubular junction
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`contradicts his statement that the Schreck valve extends into the ascending aorta.
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`However, when Dr. Hill was asked if the sinotubular junction is the transition point
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`from the aortic root to the ascending aorta, he responded, “I think that’s one inter-
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`pretation.” Hill Tr. 62:15-25 (emphasis added); see also, Hill Tr. 156:20-161:3. Dr.
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`Hill explained that “in other descriptions, the ascending aorta includes the entirety
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`of the aortic root.” Hill Tr., 165:1-13; see also, Hill Decl., ¶¶33, 65-68, 71.
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`5.
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`Response to Observation No. 5
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`Patent Owner states that Dr. Hill’s testimony regarding expansion and contraction
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`of the aorta contradicts his statement that the commissures do not cause any
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`movement of the leaflets. However, Dr. Hill testified that the commissures do not
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`cause the leaflets to move and that instead the commissures and leaflets move be-
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`cause of pressure changes due to contractions in the heart. Hill Tr., 63:1-64:23, Hill
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`Decl., ¶35; see also, Hill Tr. 105:18-106:1, 106:12-23, 109:1-6.
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`6.
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`Response to Observation No. 6
`
`Patent Owner suggests that Dr. Hill’s testimony regarding blockage of the coro-
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`nary arteries qualifies his testimony that placement and positioning of prosthetic
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`aortic valves within the aorta is within the discretion of the physician. However,
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`Dr. Hill already testified that with respect to the physician’s discretion that
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`“[p]lacement is based on, among other things, anatomical aspects of a particular
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`patient.” Hill Decl., ¶34. Dr. Hill also explained that physicians can place devices
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`“wherever they want outside or within the instructions for use” but that they would
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`take surrounding structures into account. Hill Tr., 90:16-22, 129:11-130:1.
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`7.
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`Response to Observation No. 7
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`Patent Owner suggests that Dr. Hill’s testimony regarding regurgitation qualifies
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`his testimony that “a prosthetic valve that provides less than complete fluid integri-
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`ty between adjacent valves leaflets would still achieve desired performance param-
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`4
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`IPR2014-00111
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`eters.” While Dr. Hill testified that “an ideal state would be to have minimization
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`of perivalvular leakage;” he explained that “some small leaks can be tolerated” and
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`that “[e]ven perfectly functioning prosthetic aortic valves do not fully prevent re-
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`gurgitation.” Hill Tr., 73:18-74:20, 69:16-22; Hill Decl. ¶70.
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`8.
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`Response to Observation No. 8
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`Patent Owner cites testimony by Dr. Hill where he agrees that passive prosthetic
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`valves utilize aortic pressure gradients to open and close. Hill Tr., 73:6-17. Patent
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`Owner suggests that this testimony qualifies Dr. Hill’s testimony that Figures 18
`
`and 19 do not show a structure that “mov[es] the membrane second end” as re-
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`quired by claim 16. However, the cited testimony only speaks generally as to the
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`response of passive prosthetic valves to pressure gradients and does not address
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`specific valve embodiments or structures of the ‘228 patent.
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`9.
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`Response to Observation No. 9
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`Patent Owner suggests that Dr. Hill’s testimony regarding guidance given to phy-
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`sicians on the placement of Medtronic’s CoreValve prosthetic aortic valve quali-
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`fies Dr. Hill’s testimony that placement and positioning of prosthetic aortic valves
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`is within the discretion of the physician. However, with respect to the CoreValve
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`device, Dr. Hill testified, “there's lots of debate around physicians and how they
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`interpret placement of that device.” Hill Tr., 78:14-25. Further, Dr. Hill testified
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`that “[p]lacement [of a prosthetic aortic valve] is based on, among other things, an-
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`IPR2014-00111
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`atomical aspects of a particular patient” and that physicians can put a replacement
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`valve “wherever they want outside or within the instructions for use.” Hill Decl.,
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`¶34; Hill Tr., 90:16-22, 129:11-130:1.
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`10. Response to Observation No. 10
`
`Patent Owner suggests that Dr. Hill’s testimony regarding whether a person of or-
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`dinary skill in the art needs to have taken medical classes bears upon whether to
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`accept Dr. Hill’s definition of a person of ordinary skill in the art. However, this
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`observation is irrelevant as Dr. Hill testified that, in addition to a bachelor’s degree
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`in mechanical or biomedical engineering, the ordinary person in the field would
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`have direct experience developing heart valves. Hill Decl., ¶31. Dr. Hill also testi-
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`fied that while a person with a bachelor’s degree in mechanical engineering may
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`not have taken an anatomy class, such a person would look at literature and at oth-
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`er valves to learn about valve placement. Hill Tr., 91:17-92:10, see 86:4-87:1.
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`11. Response to Observation No. 11
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`Patent Owner states that Dr. Hill testified that “a person with no medical training at
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`all, who sits in his garage and hashes out with chicken wire a mock-up of a heart
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`valve, can qualify as a person of ordinary skill in the art.” This observation is in-
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`complete. The question posed to Dr. Hill included another element, namely, that
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`the hypothetical person has an anatomy book. Hill Tr., 86:19-20 (“I’ve got in front
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`of me a book, say, the book that you helped edit.”). In response, Dr. Hill explained
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`IPR2014-00111
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`that this would constitute a person of skill in the art, because “the book – the heart
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`valve book or other book would be considered part of education in the anatomy.”
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`Hill Tr., 86:24-87:1. Dr. Hill also testified that while a person with a bachelor’s
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`degree in mechanical engineering may not have taken classes on human anatomy,
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`they would look at literature and other valves. Hill Tr., 91:17-92:10, see 86:4-87:1.
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`12. Response to Observation No. 12
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`Patent Owner states that Dr. Hill’s testimony that typically valve manufacturers tell
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`physicians where to place replacement valves qualifies his testimony regarding
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`physician discretion in placing prosthetic aortic valves. However, Dr. Hill testified
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`that physicians are able to place devices “wherever they want outside or within the
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`instructions for use.” Hill Tr., 90:16-22; see Hill Decl., ¶¶34, 68.
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`13. Response to Observation No. 13
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`Patent Owner’s observation regarding Dr. Hill’s testimony on what a person with a
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`bachelor’s degree in mechanical engineering, but no medical training, would know
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`about the placement of an aortic valve is irrelevant. Dr. Hill testified that he would
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`assume “that a person with a bachelor’s degree in mechanical engineering that was
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`going to develop a mechanical valve would look at literature, would look at other
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`valves.” Hill Tr., 92:5-10; see also, 86:8-87:1. Patent Owner suggests that Dr.
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`Hill’s testimony be discounted because he did not “verify this assumption by talk-
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`ing to people who actually were placing these valves;” however, this is irrelevant
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`in view of Dr. Hill’s educational and work experience involving the design and
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`implantation of prosthetic aortic valves. See Hill Decl., ¶¶5-16, 25-29 and Hill Tr.,
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`28:9-19, 31:8-33:19, 35:21-36:5, 38:12-41:3.
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`14. Response to Observation No. 14
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`Patent Owner states that Dr. Hill’s testimony regarding blockage of the coronary
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`arteries qualifies his testimony that placement and positioning of prosthetic valve
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`described in Schreck is within the discretion of the physician. However, Dr. Hill
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`testified, “Schreck would be adapted for placement in different locations within the
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`aortic root.” Hill Decl., ¶68. Further, Dr. Hill testified that “[p]lacement [of an arti-
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`ficial valve] is based on, among other things, anatomical aspects of a particular pa-
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`tient.” Hill Decl., ¶¶34, 68, 71; see also, Hill Tr., 90:16-22, 129:11-130:1.
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`15. Response to Observation No. 15
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`Patent Owner’s observation regarding Dr. Hill’s testimony on the sketch dated
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`Dec. 21, 1998 (Ex. 2103) is irrelevant since the cited testimony does not address
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`whether the sketch shows “’first and second spaced apart open ends’ as required by
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`claim 16” or any structures recited in claim 16. Instead, Dr. Hill’s testimony is di-
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`rected solely to whether the “ring with three intersecting lines” is a “typical way to
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`represent a tricuspid valve in a schematic drawing.” Hill Tr., 95:16-96:1.
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`16. Response to Observation No. 16
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`Patent Owner states that Dr. Hill’s testimony regarding the use of tissue in the
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`valve embodiments disclosed in the ‘228 patent contradicts his testimony that the
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`claim term “membrane” does not include “tissue.” The cited testimony is not con-
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`tradictory when placed in the proper context. When asked if the embodiments
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`shown in Figures 6-13 of the ‘228 Patent “could be constructed utilizing tissue,”
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`Dr. Hill responded that “they could be” and that “it’s likely that they could func-
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`tion with tissue.” Hill Tr., 101:6-102:5. However, when Dr. Hill was asked if the
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`interpretation of the claim term “membrane” includes “tissue,” he explained, “I
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`think within this patent they’re used distinctly.” Hill Tr., 100:19-101:2. This is
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`consistent with Dr. Hill’s testimony that one of ordinary skill reading the ‘228 pa-
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`tent “would not understand the term membrane to include tissue, particularly when
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`those terms are used so dissimilarly in the same document.” Hill Decl., ¶50.
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`17. Response to Observation No. 17
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`Patent Owner states that Dr. Hill’s testimony about how the mechanical valve em-
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`bodiments of the ‘228 patent open and close contradicts his testimony regarding
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`the “means for mounting and moving” of claim 16. The cited testimony is not con-
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`tradictory when placed in the proper context. The cited testimony does not address
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`the “means for mounting and moving” of claim 16; instead, the questions presented
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`to Dr. Hill focused on how pressure changes cause valves to open and close. See
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`Hill Tr., 104:25-106:15 (specifically, 105:14-15). With respect to the operation of a
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`natural valve, Dr. Hill agreed that “it works in the same way” as the mechanical
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`valve embodiments “in the sense that pressure changes between the left ventricle
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`and the aorta cause the leaflets to open and close.” Hill Tr., 106:16-19. Dr. Hill
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`agreed with the statement that “[t]here is no separate structure within the [tissue]
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`leaflets which facilitate them opening and closing” (Hill Tr., 107:15-18); yet, this
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`is consistent with his testimony that Figures 18 and 19 do not disclose a structure
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`that would perform the function of “moving the membrane second end” between
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`open and closed positions as required by claim 16 (Hill Decl., ¶52).
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`18. Response to Observation No. 18
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`Dr. Hill’s testimony regarding whether a surgically removed porcine valve could
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`open and close in response to pressure changes within the aorta is irrelevant to his
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`testimony regarding whether the embodiment of Figures 18 and 19 of the ‘228 pa-
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`tent discloses a structure that “mov[es] the membrane second end” between open
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`and closed positions as required by claim 16. See Hill Decl., ¶52. The cited testi-
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`mony is directed to whether a porcine valve, when placed within a ring that “spans
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`the height of the attachment from the bottom of the leaflet to the commissures” and
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`maintains the semilunar shape of the attachment, would open and close in response
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`to changes in pressure. Hill Tr., 113:24-115:16. The cited testimony does not dis-
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`cuss a “means for moving” or the tissue embodiment shown in Figures 18 and 19.
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`19. Response to Observation No. 19
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`Patent Owner’s observation that Dr. Hill’s testimony regarding the chordae
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`tendineae qualifies his testimony regarding physician discretion in placing and po-
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`sitioning the prosthetic valve described in Schreck is irrelevant. Dr. Hill already
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`testified that “[p]lacement is based on, among other things, anatomical aspects of a
`
`particular patient.” Hill Decl., ¶¶34, 68, 71; see also, Hill Tr., 90:16-22, 129:11-
`
`130:1. Dr. Hill further explained that one would “want to minimize the impact to
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`those structures [chordae tendineae]” but that it may not be completely necessary
`
`to avoid the chordae tendineae since the impact on the mitral valve depends on the
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`degree of interaction and disruption. Hill Tr., 127:8-10, 130:6-131:3.
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`20. Response to Observation No. 20
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`Dr. Hill’s testimony that the membrane disclosed in Schreck is “not directly at-
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`tached to 18 [supporting ring]” is irrelevant to his testimony that Wolfe discloses
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`cuspids that comprise a valve “membrane” and that the valve seat assembly 14 and
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`annular ring 56 constitute a “ring member” that seats about the aortic wall. Hill Tr.,
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`134:11-13; Hill Decl., ¶¶61-62. The cited testimony is also irrelevant to the general
`
`issue of “whether the membrane and ring member in Wolfe are arranged in the
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`same manner as the membrane and ring member in claim 16 of the ‘228 patent.”
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`21. Response to Observation No. 21
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`Patent Owner suggests that because Wolfe lacks specific disclosures describing
`
`adaptions that would be necessary to use the disclosed valve as an aortic valve re-
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`placement that Dr. Hill’s testimony that the “disclosed valve [in Wolfe] can be
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`used to replace aortic valves” should be qualified. However, Dr. Hill’s testimony
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`shows that Wolfe’s “Summary of the Invention” section states that the “invention
`
`disclosed can be adapted to replace the aortic valve.” Hill Tr., 135:21-136:9. Fur-
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`ther, Dr. Hill testified that it was “well known that the valve of the type shown and
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`described with respect to Wolfe could be used as an aortic valve.” Hill Decl., ¶63.
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`22. Response to Observation No. 22
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`Patent Owner suggests that Dr. Hill’s testimony on the clotting mechanism in
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`Wolfe qualifies Dr. Hill’s testimony that “the Wolfe valve would properly seal and
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`seat in a native aorta.” See Hill Decl., ¶64. The cited testimony regarding clots is
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`irrelevant as it does not address the effect on the ability to seal, but instead focuses
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`on complications such as stroke. See Hill. Tr., 137:24-138:11. Further, when asked
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`whether a person of ordinary skill in the art “would never rely upon the formation
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`of clots to maintain a device in place,” Dr. Hill responded, “I wouldn’t say they
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`would never” and then explained “I think clots are the beginning of the natural
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`healing process, so they can be construed in multiple ways.” Hill Tr., 137:12-23.
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`23. Response to Observation No. 23
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`Patent Owner states that Dr. Hill’s testimony regarding the guidelines published by
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`the European Society of Cardiology (“ESC”) contradicts his testimony that the
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`Schreck valve extends into the ascending aorta. However, Dr. Hill explained de-
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`scribing the sinotubular junction as the transition point from the aortic root to the
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`ascending aorta, as was described in the ESC Guidelines, is “one interpretation.”
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`Hill Tr. 62:15-25 (emphasis added); see also, Hill Tr. 156:20-161:3. Dr. Hill fur-
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`ther explained that “in other descriptions, the ascending aorta includes the entirety
`
`of the aortic root.” Hill Tr. 165:1-13; see also, Hill Decl., ¶¶33, 65-68, 71.
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`24. Response to Observation No. 24
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`Patent Owner states that Dr. Hill’s testimony regarding placement of the Schreck
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`valve in the “ascending aorta,” as defined in Ex. 2225, contradicts Dr. Hill’s testi-
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`mony that the Schreck valve extends into the ascending aorta and qualifies his tes-
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`timony that placement is within the discretion of the physician. The cited testimony
`
`is not contradictory or qualifying when placed in the proper context. Dr. Hill disa-
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`greed with the hypothetical placement proposed by Patent Owner’s counsel, testi-
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`fying that the Schreck device should be placed below the sinotubular junction so
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`that it is in contact with the annulus. Hill Tr., 163:14-165:5. This is consistent with
`
`Dr. Hill’s testimony that “Schreck’s disclosure expressly states that the valve is de-
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`livered to the host heart valve annulus” and “[t]he host heart valve annulus is with-
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`IPR2014-00111
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`in the aortic root and forms part of the aortic wall.” Hill Decl., ¶66. . Dr. Hill ex-
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`plained, “in other descriptions, the ascending aorta includes the entirety of the aor-
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`tic root” and that “Schreck would be adapted for placement in different locations
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`within the aortic root.” Hill Tr., 165:1-13; Hill Decl., ¶¶33, 65-68, 71.
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`25. Response to Observation No. 25
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`Patent Owner states that Dr. Hill’s testimony regarding the commissure and cup
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`posts of the Schreck valve contradicts Dr. Hill’s “criticism of Dr. Timothy Catch-
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`ings.” The cited testimony is not contradictory when placed in the proper context.
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`Dr. Hill testified that Schreck discloses slight flexing as part of the intended valve
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`operation and would not create regurgitation or peeling away of the ring from the
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`aortic wall. Hill Decl., ¶69; see, Hill Tr., 173:17-174:19. Dr. Hill explained, “flex-
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`ing of such rods is a well-known intended design attribute that is used to reduce
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`stress on the valve leaflets.” Hill Decl., ¶70. When asked how to design a device
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`that incorporates posts that are flexible enough to bend inward, but not so much
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`that the valve leaflets misalign, Dr. Hill explained he would determine the right
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`flexibility of the posts and would optimize the leaflet coaptation so that when they
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`flex the leaflets are allowed to still coapt appropriately. Hill Tr., 174:24-175:8.
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`26. Response to Observation No. 26
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`Patent Owner states that Dr. Hill’s testimony regarding misalignment of leaflets
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`disclosed in DiMatteo contradicts Dr. Hill’s criticism of Dr. Catchings description
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`IPR2014-00111
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`of leaflet misalignment. The cited testimony is not contradictory when placed in
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`the proper context. While, Dr. Hill testified that a greater degree of deformation
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`could cause misalignment of the leaflets, he explained that one “would take that
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`into account when building this device” and that one could make the valve scaffold
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`less flexible or change the cusp design to take account possible deformation. Hill
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`Tr., 191:3-6, 191:19-192:6; see also, Hill Decl., ¶59.
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`27. Response to Observation No. 27
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`Patent Owner states that Dr. Hill’s testimony regarding misalignment of leaflets
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`disclosed in DiMatteo contradicts any suggestion by Dr. Hill’s that leaflet misa-
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`lignment stems from placement of the device. The cited testimony is not contradic-
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`tory when placed in the proper context. While, Dr. Hill testified that a greater de-
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`gree of deformation could cause misalignment of the leaflets, he explained that one
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`“would take that into account when building this device” and that one could make
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`the valve scaffold less flexible or change the cusp design to take account possible
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`deformation. Hill Tr., 191:3-6, 191:19-192:6; see also, Hill Decl., ¶59.
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`Date: January 9, 2015
`
`
`
`By:
`
`Respectfully submitted,
`
`/Jack S. Barufka/
`Jack S. Barufka (Reg. No. 37,087)
`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel. 703.770.7712; Fax 703.905.2500
`
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`15
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`CERTIFICATE OF SERVICE
`
`I hereby certify that the foregoing “PETITIONER’S RESPONSE TO PATENT
`
`OWNER’S MOTION FOR OBSERVATION REGARDING CROSS-
`
`EXAMINATION OF ALEXANDER J. HILL, PH.D.” was served electronically
`
`through the Patent Trial and Appeal Board’s Patent Review Processing System
`
`(PRPS) this 9th day of January, 2015 on the following counsel for Patent Owner,
`
`James J. Kernell
`Erickson Kernell Derusseau & Kleypas, LLC
`8900 State Line Road, Suite 500
`Leawood, KS 66206
`
`Respectfully submitted,
`
`/Jack S. Barufka/
`Jack S. Barufka (Reg. No. 37,087)
`Pillsbury Winthrop Shaw Pittman LLP
`1650 Tysons Boulevard
`McLean, Virginia 22102
`Tel. No. 703.770.7712
`Fax No. 703.905.2500
`
`Attorney for Petitioner
`Medtronic, Inc.
`Medtronic Vascular, Inc.
`Medtronic CoreValve, LLC
`
`Troy R. Norred:
`
`David Marcus
`Bartle & Marcus LLC
`1100 Main Street, Suite 2730
`Kansas City, MO 64105
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`Date: January 9, 2015
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`By:
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