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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`______________________
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`
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`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
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`and MEDTRONIC COREVALVE, LLC
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`Petitioner
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`
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`v.
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`TROY R. NORRED, M.D.
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`Patent Owner
`
`______________________
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`
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`Case IPR2014-00110
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`Patent 6,482,228
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`______________________
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`
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`PATENT OWNER MOTION FOR OBSERVATION
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`PURSUANT TO 37 C.F.R. § 42.121
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`
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`Patent Owner Troy R. Norred, M.D., respectfully moves the Board to
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`observe the following testimony from the cross examination of Alexander J.
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`Hill, Ph.D. (“Hill”):
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`1.
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`In Ex. 2236, on page 33, line 23, through page 35, line 20, Hill
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`testified that his first experience with developing a heart valve was in 2006 when
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`he joined Medtronic’s vascular division, and that he did not work with any stent
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`technology at Medtronic prior to that time. This testimony is relevant to
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`paragraphs 31 and 32 of Ex. 1018. The testimony is relevant because it shows
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`Hill did not qualify as a person of ordinary skill in the art, as he has defined such
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`person, during the time frame he has defined as the relevant for purposes of this
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`inter partes review.
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`2.
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`In Ex. 2236, on page 22, line 12, through page 23, line 15, Hill
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`testified that he does not have a medical degree, has never implanted a stent or
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`artificial valve in a live human patient, and has never treated or helped treat a
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`patient suffering from aortic stenosis. This testimony is relevant to paragraphs
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`34, 35, 60, 68 and 71 of Ex. 1018. The testimony is relevant because it bears
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`upon the weight that should be afforded Hill’s testimony about where and how
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`a prosthetic aortic valve should be placed.
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`1
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`3.
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`In Ex. 2236, on page 62, lines 15 though 25, Hill testified that the
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`junction where the aortic commissures are hinged, known as the sinotubular
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`junction, could be interpreted as the transition point from the aortic root to the
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`ascending aorta. This testimony is relevant to paragraph 66 of Ex. 1018. The
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`testimony is relevant because it contradicts Hill’s statement that the Schreck
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`valve extends into ascending aorta.
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`4.
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`In Ex. 2236, on page 62, lines 5 through 25, Hill acknowledged that
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`in a medical textbook he edited entitled, Heart Valves: From Design to Clinical
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`Implantation, the ascending aorta is depicted as beginning at and extending
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`upward from the sinotublar junction. This testimony is relevant to paragraph
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`66 of Ex. 1018. The testimony is relevant because it contradicts Hill’s statement
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`that the Schreck valve extends into ascending aorta.
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`5.
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`In Ex. 2236, on page 63, line 5, through page 67, line 2, Hill testified
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`that that the aorta expands and contracts during each cardiac cycle, that the
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`commissures move with the aortic wall as it expands and contracts, that the
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`commissures are attached to the aortic valve leaflets, and that the expansion of
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`the aorta can open the aortic valve. This testimony is relevant to paragraph 35
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`of Ex. 1018. The testimony is relevant because it contradicts Hill’s statement
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`that the commissures do not cause any movement of the leaflets.
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` 2
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`6.
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`In Ex. 2236, on page 68, lines 2 through 25, Hill testified that during
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`diastole, when the aortic valve is closed, blood is directed to the right and left
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`coronary arteries to supply blood to the heart, and that if the coronary arteries
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`are blocked, the patient could die. This testimony is relevant to paragraphs 34
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`and 68 and of Ex. 1018. The testimony is relevant because it qualifies Hill’s
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`testimony that placement and positioning of prosthetic aortic valves is within
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`the discretion of the physician.
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`7.
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`In Ex. 2236, on page 69, line 16 through page 70, line 11, Hill
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`testified that in order for the cardiac cycle to work effectively and efficiently, it
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`is important that the aortic valve not allow blood to flow back into the left
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`ventricle into the aorta, and that if this occurs, it could cause the heart to fail.
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`This testimony is relevant to paragraph 70 of Ex. 1018. The testimony is
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`relevant because it qualifies Hill’s testimony that a prosthetic valve that provides
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`less than complete fluid integrity between adjacent valve leaflets would still
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`achieve desired performance parameters.
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`8.
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`In Ex. 2236, on page 73, lines 6 through 17, Hill agreed that a
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`prosthetic heart valve must necessarily function in the same manner as the
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`natural valve it replaces, and thus passive prosthetic valves utilize the pressure
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`gradient created during systole and diastole to open and close. This testimony is
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` 3
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`relevant to paragraph 52 of Ex. 1018. The testimony is relevant because it
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`qualifies Hill’s testimony that Figs. 18 and 19 of the ’228 patent do not disclose a
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`structure performing the function of “‘moving the membrane second end’
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`between open and closed positions.”
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`9.
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`In Ex. 2236, on page 80, line 10 through page 82, line 2, Hill
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`testified that in the case of Medtronic’s CoreValve prosthetic aortic valve, the
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`physician was given guidance about where the valve should be placed and
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`“malposition/malplacement” was listed as a “Potential Adverse Event.” This
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`testimony is relevant to paragraphs 34 and 68 and of Ex. 1018. The testimony is
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`relevant because it qualifies Hill’s testimony that placement and positioning of
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`prosthetic aortic valves is within the discretion of the physician.
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`10.
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`In Ex. 2236, on page 84, line 3 through page 86, line 3, Hill testified
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`that a person of ordinary skill in the art, as he has defined such person, need not
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`have taken any medical classes. This testimony is relevant to paragraph 31 of
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`Ex. 1018. The testimony is relevant because it bears upon whether Hill’s
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`definition of a person or ordinary skill the art should be accepted for purposes of
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`this in partes review.
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`11.
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`In Ex. 2236, on page 86, line 16 through page 87, line 1, Hill
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`testified that a person with no medical training at all, who sits in his garage and
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` 4
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`hashes out with chicken wire a mock-up of a heart valve, can qualify as a person
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`of ordinary skill in the art as Hill has defined such person. This testimony is
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`relevant to paragraph 31 of Ex. 1018. The testimony is relevant because it bears
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`upon whether Hill’s definition of a person or ordinary skill the art should be
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`accepted for purposes of this in partes review.
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`12.
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`In Ex. 2236, on page 90, line 7 through page 87, line 3, Hill testified
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`that physicians are told where a prosthetic aortic valve is supposed to be placed,
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`and if the physician places it elsewhere, it is considered an off-label use. This
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`testimony is relevant to paragraphs 34 and 68 and of Ex. 1018. The testimony is
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`relevant because it qualifies Hill’s testimony that placement and positioning of
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`prosthetic aortic valves is within the discretion of the physician.
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`13.
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`In Ex. 2236, on page 91, line 17 through page 93, line 1, Hill
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`testified he made an assumption that a person with a bachelor’s degree in
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`mechanical engineering but absolutely no medical training would nonetheless
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`know where a prosthetic aortic valve should be placed, but acknowledged he did
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`not verify this assumption by talking to people who actually were placing these
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`valves. This testimony is relevant to paragraphs 34, 35, 60, 68 and 71 of Ex.
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`1018. The testimony is relevant because it bears upon the weight that should be
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` 5
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`afforded Hill’s statements about where and how a person of ordinary skill in the
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`art, as he has defined such person, would place a prosthetic aortic valve.
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`14.
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`In Ex. 2236, on page 94, lines 4 through 22, Hill testified if an
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`artificial valve were placed in a position where, upon closing, it prevented blood
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`from flowing back through the coronary arteries, it typically would kill the
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`patient. This testimony is relevant to paragraph 68 of Ex. 1018. The testimony
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`is relevant because it qualifies Hill’s testimony that placement and positioning of
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`the prosthetic valve described in the Schreck patent, Ex. 2098, is within the
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`discretion of the physician.
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`15.
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`In Ex. 2236, on page 95, line 16 through page 96, line 1, Hill
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`testified that the manner in which Norred depicted an aortic valve in his
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`notarized drawing of December 21, 1998, Ex. 2003, is a typical way to depict a
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`tricuspid valve. This testimony is relevant to the argument on pages 7 and 8 of
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`Petition’s Reply to Patent Owner Response (Paper 25) that there are no “‘first and
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`second spaced apart open ends’ [in the December 21, 1998 drawing] as required
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`by claim 16.” The testimony is relevant because it bears upon what structural
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`components the December 21, 1998 drawing should be construed to encompass.
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`16.
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`In Ex. 2236, on page 101, line 3 through page 106, line 11, Hill
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`testified that with the possible exception of Figs. 18 and 19, each of the valve
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` 6
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`embodiments in the ’228 Patent could function with tissue. This testimony is
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`relevant to paragraph 50 of Ex. 1018. The testimony is relevant because it
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`contradicts Hill’s testimony that one of ordinary skill in the art would not
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`understand the term membrane as used in the ’228 patent to include tissue.
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`17.
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`In Ex. 2236, on page 104, line 25 through page 107, line 18, Hill
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`testified that with the respect to each of the mechanical valve embodiments
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`depicted in the ’228 Patent, the valve opens and closes in response to changes in
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`the pressure gradient between the left ventricle and the aorta in the same way
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`the natural valve opens and closes; there is not a separate structure within the
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`valve leaflets to facilitate the opening and closing of the valve. This testimony is
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`relevant to paragraphs 46 and 52 of Ex. 1018. The testimony is relevant because
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`it contradicts Hill’s testimony that Figs. 10 through 13 and 14 through 17 of the
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`’228 patent disclose a structure performing the function of “‘moving the
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`membrane second end’ between open and closed positions” and Figs. 18 and 19
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`do not include such structure.
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`18.
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`In Ex. 2236, on page 112, line 12 through page 115, line 16, Hill
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`testified that a cadaver or porcine valve, as called for in Figs. 18 and 19 of the
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`’228 patent, could open and close in response to pressure changes within the
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`aorta so long as it was properly extracted from the donor and properly placed
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` 7
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`
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`within the patient. This testimony is relevant to paragraph 52 of Ex. 1018. The
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`testimony is relevant because it qualifies Hill’s testimony that Figs. 18 and 19 of
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`the ’228 patent do not disclose a structure performing the function of “‘moving
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`the membrane second end’ between open and closed positions.”
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`19.
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`In Ex. 2236, on page 125, line 18 through page 127, line 10, Hill
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`testified that in placing a prosthetic aortic valve in the heart, the surgeon would
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`want to avoid the subvalvular structures associated with the mitral valve because
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`interference with these structures could cause the patient to die. This testimony
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`is relevant to paragraphs 34 and 68 and of Ex. 1018. The testimony is relevant
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`because it qualifies Hill’s testimony that placement and positioning of prosthetic
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`aortic valves is within the discretion of the physician.
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`20.
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`In Ex. 2236, on page 131, line 13 through page 1, line 18 through
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`page 134, line 13, Hill testified with regard to the Wolfe patent, Ex. 1006, the
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`structure Medtronic has identified as a membrane is not directly attached to the
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`structure Medtronic has identified as a ring member adapted to seat against the
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`aortic wall. This testimony is relevant to paragraphs 61 and 62 of Ex. 1018. The
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`testimony is relevant because it bears whether the membrane and ring member
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`in Wolfe are arranged in the same manner as the membrane and ring member in
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`claim 16 of the ’228 patent.
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` 8
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`21.
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`In Ex. 2236, on page 134, line 24 through page 136, line 9, Hill
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`testified that the Wolfe patent, Ex. 1006, is describes a device designed to replace
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`the mitral valve, not the aortic valve, and that although the device can be
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`“adapted” to replace the aortic valve, the necessary adaptations are not described
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`in the patent. This testimony is relevant to paragraph 63 of Ex. 1018. The
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`testimony is relevant because it qualifies Hill’s statement that “the disclosed
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`valve [in Wolfe] can be used to replace aortic valves.”
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`22.
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`In Ex. 2236, on page 137, line 24 through page 138, line 11, Hill
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`testified that while the device described in the Wolfe patent, Ex. 1006, relies on
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`the formation of clots to seal, a person of ordinary skill in the art would avoid
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`clots because they can lead to complications such as stroke. This testimony is
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`relevant to paragraph 64 of Ex. 1018. The testimony is relevant because it
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`qualifies Hill’s testimony that the Wolfe valve would properly seal in a native
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`aorta.
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`23.
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`In Ex. 2236, on page 165, line 25 through page 168, line 2, Hill
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`acknowledged that guidelines published by the European Society of Cardiology
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`depict the ascending aorta as beginning at and extending upward from the
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`sinotubular junction. This testimony is relevant to paragraph 66 of Ex. 1018.
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` 9
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`
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`The testimony is relevant because it contradicts Hill’s statement that the Schreck
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`valve extends into ascending aorta.
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`24.
`
`In Ex. 2236, on page 163, line 14 through page 168, line 2, Hill
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`testified that the Schreck patent, Ex. 2098, does not describe a prosthetic valve
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`having a stent that can be placed in the ascending aorta as the ascending aorta is
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`defined in the medical textbook Hill edited entitled, Heart Valves: From Design
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`to Clinical Implantation, and in guidelines published by the European Society of
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`Cardiology, and that if the stent were placed in the ascending aorta, the valve
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`leaflets would occlude the coronary arteries when they closed. This testimony is
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`relevant to paragraph 66 and 68 of Ex. 1018. The testimony is relevant because
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`it contradicts Hill’s statement that the Schreck valve extends into ascending
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`aorta, and qualifies Hill’s statement that placement and positioning of the
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`Schreck valve is within the discretion of the physician.
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`25.
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`In Ex. 2236, on page 182, lines 3 through 22, Hill testified that the
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`commissure and cusp posts incorporated into the device described in the Schreck
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`patent, Ex. 2098, could cantilever inward to a sufficient degree that they could
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`affect the alignment of the valve leaflets and cause aortic regurgitation. This
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`testimony is relevant to paragraphs 69 and 70 of Ex. 1018. The testimony is
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`relevant because it contradicts Hill’s criticism of Dr. Timothy Catchings, who
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` 10
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`described problems associated with the commissure and cusp posts cantilevering
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`inward.
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`26.
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`In Ex. 2236, on page 185, line 25 though page 187, line 19, Hill
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`testified if the device described in the DiMatteo patent, Ex. 1003, were placed in
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`a passageway where it was forced to adapt from the circular shape depicted in
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`Figs. 2, 4, 13C, 24B and 25B, to more of an oval shape, the leaflets could misalign
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`and allow aortic regurgitation to occur. This testimony is relevant to paragraphs
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`59 and 60 of Ex. 1018. The testimony is relevant because it contradicts Hill’s
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`criticism of Dr. Timothy Catchings, who described the manner in which the
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`DiMatteo leaflets could misalign.
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`27.
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`In Ex. 2236, on page 190, line 18 though page 192, line 13, Hill
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`testified that in order to keep the leaflets from misaligning in the device depicted
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`in the DiMatteo patent, Ex. 1003, it would be necessary to construct the device
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`of rigid material so it does not adapt to the shape of the aorta upon placement,
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`or to construct the device so that it matches the shape of the aorta and does not
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`need to adapt to seat against the aortic wall. This testimony is relevant to
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`paragraph 60 of Ex. 1018. The testimony is relevant because it contradicts Hill’s
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`suggestion that any alignment problems with the DiMatteo valve stem from the
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`placement of the device rather than its design and construction.
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` 11
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`Respectfully Submitted,
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`By: /s/ James J. Kernell
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`James J. Kernell, Reg. No. 42720
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`ERICKSON KERNELL DERUSSEAU
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`& KLEYPAS, LLC
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`8900 State Line Road, Suite 500
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`Leawood, Kansas 66206
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`Telephone: (913) 549-4700
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`Facsimile: (913) 549-4646
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`Email: jjk@kcpatentlaw.com
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`
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`David L. Marcus (pro hac vice)
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`BARTLE & MARCUS LLC
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`1100 Main Street, Suite 2730
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`Kansas City, Missouri 64105
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`Telephone: (816) 256-4699
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`Facsimile: (816) 222-0534
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`Email: dmarcus @bmlawkc.com
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`Attorneys for Patent Owner
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`Troy Norred, M.D.
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`CERTIFICATE OF SERVICE
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`I hereby certify that on this 31st day of December 2014, the foregoing
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`Patent Owner Motion for Observation Pursuant to 37 C.F.R. § 42.121 has been
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`served electronically through the Patent Trial and Appeals Board’s Patent
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`Review Processing System (PRPS) upon the lead and back-up counsel for the
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`Petitioner, JACK BARUFKA and EVAN FINKEL, both of Pillsbury Winthrop
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`Shaw Pittman LLP.
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`/s/ James J. Kernell
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`Attorney for Patent Owner
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` 13
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