UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
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`v.
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`TROY R. NORRED, M.D.
`Patent Owner
`______________________
`
`Case IPR2014-00110
`Patent 6,482,228
`______________________
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`PATENT OWNER REPLY IN SUPPORT OF MOTION TO AMEND
`PURSUANT TO 37 C.F.R. § 42.121
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`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
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`v.
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`TROY R. NORRED, M.D.
`Patent Owner
`______________________
`
`Case IPR2014-00110
`Patent 6,482,228
`______________________
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`PATENT OWNER REPLY IN SUPPORT OF MOTION TO AMEND
`PURSUANT TO 37 C.F.R. § 42.121
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`Exhibit List
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`Table of Authorities
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`I.
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`TABLE OF CONTENTS
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`The Amendments Do Not Enlarge the Scope of the Claim and
`Are Responsive to a Ground of Unpatentability
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`Claim Constructions Are Not Needed for New Terms
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`II.
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`III. Norred Provided Support for the Substitute Claim
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`IV. Norred Showed that the Substitute Claim is Patentable
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`EXHIBIT LIST
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`Exhibit Description
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`Exhibit No.
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`U. S. Patent No. 6,482,228 to Norred
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`U. S. Patent No. 6,440,164
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`U. S. Patent No. 6,245,101 to Drasler et al
`Transcript of deposition of Timothy Titus Catchings, M.D.
`conducted on October 7, 2014
`Transcript of deposition of Troy R. Norred, M.D. conducted on
`October 8, 2014
`GermanPatent DE19546692 to Figulla – Filed application with
`translation
`Declaration of Thomas Vassiliades, Jr., M.D.
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`Percutaneous Aortic Valve Replacement
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`Declaration of Troy R. Norred, M.D.
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`Declaration of Timothy Catchings, M.D.
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`U. S. Patent No. 6,454,799 to Schreck
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`U. S. Patent No. 5,957,949 to Leonhardt et al.
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`U. S. Patent No. 4,084,268 to Ionescu et al.
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`U. S. Patent No. 4,477,930 to Totten et al.
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`U. S. Patent No. 6,059,827 to Fenton, Jr.
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`U. S. Patent No. 6,139,575 to Shu et al.
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`U. S. Patent No. 5,411,552 to Anderson et al.
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`U. S. Patent No. 5,855,597 to Jayaraman
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`U. S. Patent No. 6,425,916 to Garrison et al.
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`U. S. Patent No. 6,458,153 to Bailey et al.
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`German Patent DE19857887
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`Schreck illustration to Catchings Deposition (Ex. 1009)
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`Schreck illustration to Catchings Deposition (Ex. 1009)
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`Schreck illustration to Catchings Deposition (Ex. 1009)
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`DiMatteo illustration to Catchings Deposition (Ex. 1009)
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` iii
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`1001
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`1003
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`1008
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`1009
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`1010
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`1013
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`1020
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`2010
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`2093
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`2095
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`2098
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`2099
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`2101
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`2102
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`2113
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`2114
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`2116
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`2119
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`2122
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`2123
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`2126
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`2129
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`2130
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`2131
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`2132
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`DiMatteo illustration to Catchings Deposition (Ex. 1009)
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`DiMatteo illustration to Catchings Deposition (Ex. 1009)
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`2133
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`2134
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` iv
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`TABLE OF AUTHORITIES
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`Cf. Beckson Marine, Inc. v. NFM, Inc.,
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`144 Fed. Appx. 862 (Fed. Cir. 2005)
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` v
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`I.
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`The Amendments do not Enlarge the Scope of the Claim
`and are Responsive to a Ground of Unpatentability
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`Original claim 16 includes a means-plus-function limitation, “means for mount-
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`ing said first open end of said membrane about said aperture.” (Ex. 1001, 8:7-8.) The
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`Board construed this to mean the membrane is “hingedly secured” or “hingedly at-
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`tached” to the aperture of the ring. Paper 10 at 10. Claim 25 adopts this construct-
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`ion, replacing the means-plus-function limitation with language specifying the mem-
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`brane is “hingedly secured about said aperture of said ring member.” Paper 26 at 2.
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`Petitioner argues Claim 16 must be interpreted to include “fingers or arms” be-
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`cause these structures are necessary to perform the required function. Petitioner’s Opp.
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`at 4. Because the proposed amendment does not include “fingers or arms,” it pur-
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`portedly broadens the scope of the claim. Id. at 6. This argument is misplaced.
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`Claim 16 is not limited to embodiments that include fingers or arms. It also
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`encompasses cadaver and porcine valves as depicted in Figs. 18 and 19. (Ex. 1001,
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`2:49-51, 5:63-6:8; see also Paper 10 at 7, membrane). In these embodiments, the mem-
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`brane attaches directly to the ring aperture and functions as a hinge, allowing the valve
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`to move between a closed position and an open position. (Ex. 2095, ¶ 35.) This is
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`how natural valves work, as Petitioner’s own expert acknowledges. (IPR20140-00111,
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`Ex. 1020, ¶¶ 23-28.) No other structures are necessary to perform the required funct-
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`ion. Accordingly, no other structures must be included in the proposed amendment
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`to prevent it from broadening the claim. Cf. Beckson Marine, Inc. v. NFM, Inc., 144
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`Fed. Appx. 862 (Fed. Cir. 2005) (“means hingedly connecting” must be interpreted
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`under § 112, ¶ 6 because the “means” language was used and no specific structure was
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`identified).
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`II. Claim Constructions Are Not Needed for New Terms
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`The terms in Claim 25 should be given their ordinary and customary meanings,
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`consistent with the Specification, as those terms would be understood by one of ordi-
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`nary skill in the art. Special claim constructions are not required because the terms are
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`not subject to dispute. Petitioner attempts to create a dispute regarding the term “pli-
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`able” by suggesting that Drs. Catchings and Norred disagree about whether super-
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`elastic material as used in DiMatteo (Ex. 1003) can be pliable. This suggestion is mis-
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`leading. Dr. Catchings testified that a superelastic stent is a stent that is “easily mal-
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`leable … [and] can be twisted, turned, moved into shape easily without permanent de-
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`formity.” (Ex. 1009, 181:10-15.) Dr. Norred did not disagree with this point. (Ex.
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`1010, 84:5-85:5.) Instead, he stated that once deployed, the trellis 24/line 82 com-
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`bination in DiMatteo must maintain a perfectly circular shape. Response to Petition at
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`35-36. This means it must be rigid. Id. Otherwise, if the trellis 24/liner 82 com-
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`bination is malleable/pliable when deployed, it will conform to the irregular shape of
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`the aortic wall and the valve leaflets will misalign. Id. (See also Ex. 1009, 247:11-
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`248:12; Ex. 2133 (illustration).)
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`III. Norred Provided Support for the Substitute Claim
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`The ‘228 patent is not limited to prosthetic valves incorporating balloon-
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`expandable stents. While the specification discusses the use of a balloon to place the
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`valve prosthesis (Ex. 1001, 2:61-3:12), this is merely a method of placement. It is not
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`a description of the device being placed. The device being placed is described as a
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`“stent system made up of a small slotted stainless tube or series of interconnected
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`rods which form an expandable lattice or scaffolding” (Ex. 1001, 2:61-63). Both bal-
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`loon-expandable and self-expanding stents can be constructed in such manner (see gen-
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`erally Ex. 1008, 1:59-6:21).
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`The stent system is incorporated into claims 19 and 20 through the means-plus-
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`function language. The combination of rods 104 interacting with stent 28 is the struc-
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`ture that maintains the ring member against the aortic wall. Paper 10 at 10. This is
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`what makes the valve prosthesis operable and is an integral part of Norred’s inven-
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`tion. (See Ex. 1001, Abstract, 1:6-10, 29-31, 2:62-63, 3:1-45, Figs. 1-5.)
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`IV. Norred Showed that the Substitute Claim Is Patentable
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`Norred studied 33 prior art references for his Motion to Amend. None of
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`them anchor in place through a means of a stent system that extends into the ascend-
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`ing aorta, as is required by Claim 25. Instead, in almost all cases where a stent is used,
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`it is confined to the native annulus. (See, e.g., Exs. 2116, 2122 & 2123). These “short
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`stent” designs cannot displace aortic pressure in a manner mimicking the native valve.
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`(Ex. 2095, ¶ 31; Ex. 2093, ¶ 80.) Only one prior art reference describes a longer stent
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`(Ex. 1013), and in that case, the stent relies upon barbs to anchor it to the aortic wall,
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`creating a risk of aortic dissection and infection. (Ex. 2095, ¶ 48; Ex. 2093, ¶ 73.)
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`Similarly, none of the prior art references incorporate a ring member having a
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`pliable circumference adapted to seat about an aortic wall surrounding an aortic chan-
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`nel and seal against a root of a native aortic valve upon percutaneous placement. In-
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`stead, in cases where a ring member of some sort is used, it is not pliable (see, e.g., Exs.
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`2113 & 2114), it will not seal (see, e.g., Exs. 2099 & 2119), or it will not seal upon per-
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`cutaneous placement (see, e.g., Exs. 2101 & 2102). These differences are functionally
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`significant. (Ex. 2095, ¶¶ 28, 32 & 33.)
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`It is not possible to combine these prior art references to create the device de-
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`scribed in Claim 25 because vital elements—the stent and ring member—are wholly
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`absent. Prior to the ‘228 Patent, there was nothing in the art that taught or suggested
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`a valve prosthesis that could be held in place with the stent alone and displace aortic
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`pressure in a manner mimicking the native valve, and that incorporated a ring member
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`having a pliable circumference adapted to seat about an aortic wall surrounding an
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`aortic channel and seal against the root of a native aortic valve upon percutaneous
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`placement. (See Ex. 2095, ¶¶ 31, 40-51; Ex. 2093, ¶¶62, 73, 74, 80.)
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`In opposing Norred’s Motion to Amend, Petitioner highlights four prior art
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`references as purportedly significant: Figulla (Ex. 1013), Fraunhofer (Ex. 2126),
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`Schreck (Ex. 2098) and DiMatteo (Ex. 1003). Figulla incorporates a stent that extends
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`into the ascending aorta, but it anchors to the aortic wall with barbs and has no ring
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`member. (Ex. 1013, Fig. 2.) Fraunhofer and Schreck have “short stent” designs, not
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`the stent required by Claim 25, and rely upon hooks or barbs to attach to the aortic
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`wall. (Ex. 2126, p. 3, ll. 41-49, p. 4, ll. 1-5; Ex. 2098, 13:29-31, 13:63-14:5, 15:7-11,
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`Fig. 16C.) Fraunhofer does not include a ring member. Schreck has a structure that
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`could serve as a ring member, but its “short stent” design and elongated commissure
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`posts compromises its ability to seal against root of the native valve. (Ex. 2098, Figs.
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`6 & 7; Exs. 2129, 2130 & 2131; Ex. 1009, 249:6-255:16.) DiMatteo’s purported ring
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`member must be rigid, rather than pliable, so it maintains its circular shape upon
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`placement, allowing the valve leaflets to properly align. (Exs. 2132, 2133 & 2134; Ex.
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`1009, 245:14-248:12.) None of these prior art references, alone or in combination,
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`contain the elements of Claim 25.
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`While several surgically implanted devices incorporate pliable rings (see, e.g.,
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`Exs. 2010 & 2102), these rings are not adapted to seal against the root of the native
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`valve upon percutaneous placement. Instead, they are designed to hold sutures. (See,
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`e.g., Ex. 2102, 4:77-18, 6:50-7:5.) The sutures pull the ring and the surrounding tissue
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`together to create a seal. See id. It would not have been obvious to incorporate these
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`“sewing” rings into a valve design where sutures are not used. The idea that a seal
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`could be created without sutures, through radial force alone, was wholly novel.
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`Respectfully Submitted,
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`ERICKSON KERNELL
`DERUSSEAU & KLEYPAS, LLC
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`/s/ James J. Kernell
`James J. Kernell, Reg. No. 42720
`Phone: (913) 549-4700 Fax: (913) 549-4646
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`CERTIFICATE OF SERVICE
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`I hereby certify this November 24, 2014, that the foregoing Patent Owner Re-
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`ply in Support of Motion to Amend has been served electronically through the Patent
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`Trial and Appeals Board’s Patent Review Processing System (PRPS) upon the lead
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`and back-up counsel for the Petitioner, JACK BARUFKA, 1650 Tysons Boulevard,
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`McLean, Virginia 22102; and EVAN FINKEL, 725 South Figeuroa Street, Suite 2700,
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`Los Angeles, California 90017, both of Pillsbury Winthrop Shaw Pittman LLP.
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`/s/ James J. Kernell
`Attorney for Patent Owner
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