UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`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 IPR2014-00110
`Patent 6,482,228
`______________________
`
`PATENT OWNER SUBSTITUTE MOTION TO AMEND
`PURSUANT TO 37 C.F.R. § 42.121
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`I.
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`TABLE OF CONTENTS
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`SUMMARY OF SUBSTITUTE MOTION TO AMEND ..................................... 1
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`II. CLAIM LISTING ......................................................................................................... 1
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`III. DISCUSSION OF PROPOSED CHANGED ........................................................ 2
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`IV. ALLOWABILITY OF PROPOSED SUBSTITUTE CLAIM ............................... 4
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`A.
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`Proposed Substitute Claim 25. ................................................................................ 5
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`1. Significance of Proposed New Features ................................................................ 5
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`a. Configured for Percutaneous Placement ........................................................... 6
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`b. Expandable Stent that Extends into the Aorta ................................................. 6
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`c. Pliable Ring Member ............................................................................................ 7
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`2. No Broadening of Scope ......................................................................................... 8
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`3. Written Description Support .................................................................................. 8
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`B.
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`Patentability Over Prior Art .................................................................................... 8
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`1. Level and Knowledge of Person of Ordinary Skill in the Art ............................ 8
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`2. Prior Art of Record and Known Prior Art ........................................................... 8
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`a. Closest Prior Art Known ..................................................................................... 8
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`b. Other Known Prior Art ..................................................................................... 11
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`i.
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`Surgically-Implanted “Hancock” Style Valves ................................................. 11
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`ii. Other Surgically-Implanted Valves .................................................................. 13
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`iii. Percutaneously-Implanted Valves ..................................................................... 13
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`V. CONCLUSION ............................................................................................................ 14
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`ii
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`

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`
`
`Statutes
`
`TABLE OF AUTHORITIES
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`37 C.F.R. § 42.121 .................................................................................................................. 1
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`37 C.F.R. § 42.121(a)(3) ......................................................................................................... 1
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`37 C.F.R. §§ 42.121(b)(1)-(2) ................................................................................................. 1
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`
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`Other Authorities
`Bortaoltti U, Milano A, Guerra F, et al,
`Failure of Hancock Pericadial Xenografts: Is Prophylactic Bioprosthetic Replacement Justified?
`Ann Thorac Surg 1991; 51:430-7 .................................................................................... 13
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`iii
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`I.
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`SUMMARY OF SUBSTITUTE MOTION TO AMEND
`
`Patent Owner Troy R. Norred, M.D. (“Patent Owner”) submits this
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`substitute motion to amend in compliance with 37 C.F.R. § 42.121. In the event that
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`both claims 16 and 19 are deemed unpatentable, Patent Owner requests that claim 25,
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`as presented herein, be substituted for claim 16. If either claim is deemed patentable,
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`then no amendment is requested. One claim (claim 25) is proposed as a substitute for
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`original claim 16. Accordingly, this motion to amend satisfies the general
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`presumption that “only one substitute claim would be needed to replace each
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`challenged claim.” 37 C.F.R. § 42.121(a)(3). Support for the proposed claim from
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`“the original disclosure of the patent” is provided below. See 37 C.F.R. §§
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`42.121(b)(1)-(2).
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`II. CLAIM LISTING
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`Proposed substitute claim is shown below in markup form as compared
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`to the original claim for which it is proposed as a substitute.
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`25. (Proposed substitute for claim 16) An aortic valve for regulating a
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`blood flow through an aortic channel surrounded by an aortic wall upon percutaneous
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`placement therein, said valve comprising:
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`a ring member having a pliable circumference adapted to seat about an aortic
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`wall surrounding an aortic channel and seal against a root of a native
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`aortic valve upon percutaneous placement, said ring member including
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`-1-
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`an aperture for blood flow therethrough;
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`an expandable stent system extending into the ascending aorta upon said
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`percutaneous placement therein and connected to said ring member; and
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`a membrane having first and second spaced-apart open ends, said membrane
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`made of a material resistant to a fluid flow therethrough;
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`means for mounting said first open end of said membrane hingedly secured
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`about said ring aperture of said ring member with said second open end
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`displaced therefrom, said means moving said membrane second open
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`end movable between a first open position to allow a blood flow
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`therethrough and a second closed position to preclude blood flow
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`therethrough;
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`said aortic valve having a collapsed configuration for delivery inside a catheter,
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`and an expanded configuration when deployed from said catheter and
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`percutaneously placed in the aortic channel.
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`III. DISCUSSION OF PROPOSED CHANGED
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`Proposed substitute independent claim 25 includes all of the elements of
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`the original independent claim 16, as well as additional elements as shown above. In
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`particular, proposed substitute claim 25 narrows the scope of claim 16 by specifying
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`that the ring member has a “pliable” circumference. Claim 25 narrows the scope of
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`claim 16 by specifying that the ring member “seal[s] against a root of a native aortic
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`valve upon percutaneous placement.” The limitation of “an expandable stent system
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`extending into the ascending aorta upon said percutaneous placement therein and
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`connected to said ring member” has been included in claim 25, narrowing claim 16 by
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`specifically claiming the “means for maintaining” set forth in original dependent claim
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`19. The limitation of “hingedly secured” has been included in claim 25, narrowing
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`claim 16 by specifically claiming the “means for mounting” set forth in original
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`dependent claim 19. The limitation “aperture of said ring member” replacing “ring
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`member aperture” in original claim 16 is substitute language that neither narrows nor
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`broadens claim 16. The limitation “said means moving” has been deleted because the
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`referenced means has been replaced with the specific limitation set forth above. The
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`limitation “open” has been added between “second” and “end” to specifically refer to
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`previously claimed limitation. The narrower limitation “movable” has been included
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`in claim 25 in place of “moving” in original claim 16, with reference to the “second
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`open end.” Finally, claim 25 includes “a collapsed configuration for delivery [of the
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`aortic valve] inside a catheter, and an expanded configuration when deployed from
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`said catheter and percutaneously placed in the aortic channel,” which further narrows
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`claim 16.
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`The additional elements in proposed substitute claim 25 finds support in
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`the original disclosure of the patent (U.S. App. Ser. No. 09/712,121 (the ‘121
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`application, Ex. 1002) which issued as U.S. Pat. No. 6,482,228). Support for the
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`following terms as used in Claim 25 can be found in Ex. 1001 as follows:
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`percutaneous - Title; Abstract; Figs. 1-5; 1:1, 7-9, 26-27, 32-33, 53-55, 58-60; 1:67-
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`2:2; 2:55-3:18; 5:33-35; 63-67; 6:11-14; pliable, and seal against a root of a native
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`aortic valve - 5:19-21; 6:2-4; an expandable stent system extending into the
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`ascending aorta upon said percutaneous placement therein and connected to
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`said ring member - Abstract; Figs. 1-5; 1:29-31, 60-68; 3:7-10; 5:21-23, 48-51; 6:4-9;
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`hingedly secured – Figs. 10-19; 4:56-61; 5:35-39; movable - Figs. 6, 8, 10, 12, 14,
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`16; 4:36; collapsed configuration for delivery inside a catheter – Title; Abstract;
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`Figs. 1 and 2; 1:1, 7-9, 26-27, 32-33, 53-55, 58-60; 1:67-2:2; 2:55-3:18; 5:33-35; 63-67;
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`6:11-14; and expanded configuration once deployed from said catheter – Title;
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`Abstract; Figs. 3-5; 1:1, 7-9, 26-27, 32-33, 53-55, 58-60; 1:67-2:2; 2:55-3:18; 5:33-35;
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`63-67; 6:11-14.-51; 4:65-5:13; 5:43-47.
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`IV. ALLOWABILITY OF PROPOSED SUBSTITUTE CLAIM
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`On October 31, 2013, Medtronic, Inc., Medtronic Vascular, Inc. and
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`Medtronic CoreValve, LLC (collectively, “Petitioner”) requested an inter partes review
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`proposing four grounds of rejection. On April 25, 2014, the Patent Trial and Appeal
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`Board issued a decision instituting an inter partes review with respect to two of the
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`grounds of rejection. The grounds of rejection are based on one or more of the
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`following references (collectively, “the cited references”): US 6,440,164 (“DiMatteo”),
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`and US 4,030,142 (“Wolfe”).
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`A.
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`Proposed Substitute Claim 25.
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`As set forth above, proposed substitute claim 25 relates to a prosthetic
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`aortic valve that is placed percutaneously – not surgically. The aortic valve is
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`anchored in place by a stent system exerting radial force against the aortic wall. The
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`stent system eliminates the need for sutures. The stent system extends into the
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`ascending aorta to provide the necessary surface area to circumferentially disperse the
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`force in the aorta to reduce the stress and strain on the valve leaflets. Additionally,
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`the extended stent structure makes it significantly easier to place and correctly align
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`the valve. Finally, the ring member seats about the aortic wall and seals against the
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`root of the native aortic valve upon percutaneous placement to reduce perivalvular
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`leaks.
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`1.
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`Significance of Proposed New Features
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`No prior art device discloses, teaches, or suggests an aortic valve, which
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`has a collapsed configuration for delivery within a catheter and an expanded
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`configuration when deployed, which anchors the valve in place with a stent system
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`that extends into the ascending aorta, and which includes a pliable ring member that
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`seats about the aortic wall and seals against the root of the native aortic valve to
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`reduce perivalvular leaks. A person of ordinary skill in the art would consider each of
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`these features, found in claim 25, to be highly significant in terms of patient care.
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`Declaration of Timothy T. Catchings, M.D., (“Catchings Decl.”), ¶¶ 28-32, filed as Ex. 2095.
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`-5-
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`a.
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`Configured for Percutaneous Placement
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`Having a collapsed configuration allows the prosthetic aortic valve set
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`forth in claim 25 to be placed within a catheter for percutaneous delivery. Catchings
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`Decl. ¶ 29; Declaration of Troy R. Norred, M.D., (“Norred Decl.”), ¶ 62, filed as Ex. 2093.
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`This means surgery is not necessary to place the valve. Catchings Decl. ¶ 30; Norred
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`Decl. ¶ 17. This is significant because of the trauma associated with surgical aortic
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`valve replacement. Catchings Decl. ¶ 23; Norred Decl. ¶¶ 11, 12. Surgical aortic valve
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`replacement requires, among other things, that a patient’s heart be stopped and the
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`patient placed on a cardiopulmonary bypass machine. Catchings Decl. ¶ 23; Norred Decl.
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`¶ 11. Elderly and infirm patients often are unable to tolerate this procedure and
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`therefore cannot receive a surgically placed aortic valve. Catchings Decl. ¶ 23; Norred
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`Decl. ¶¶ 13, 17. They could, in contrast, receive the percutaneously-placed valve set
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`forth in claim 25.
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`b.
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`Expandable Stent that Extends into the Aorta
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`Having an expandable stent system that extends into the aorta means the
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`prosthetic aortic valve set forth in claim 25 can anchor in place using the stent alone.
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`Catchings Decl. ¶¶ 24, 26, 30; Norred Decl. ¶ 62. This means there is no need for sutures,
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`which only can be placed through surgery. Catchings Decl. ¶ 30; Norred Decl. ¶¶ 61, 62.
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`This also means there is no need for barbs, hooks or flanges, which can lead to aortic
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`dissection, perforation and infection. Catchings Decl. ¶ 45; Norred Decl. ¶¶ 73, 74, 75.
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`Further, this stent—unlike stents that are confined to the native annulus—can mimic
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`the function of the native valve and disperse force circumferentially throughout the
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`device. Catchings Decl. ¶ 20; Norred Decl. ¶ 82. This reduces the stress and strain on the
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`leaflets and increases the longevity of the valve. Catchings Decl. ¶ 82; Norred Decl. ¶ 20.
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`c.
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`Pliable Ring Member
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`Having a pliable ring member allows the prosthetic aortic valve set forth
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`in claim 25 to seat against the aortic wall and seal against the root of the native aortic
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`valve. If the ring member were not pliable, it could not seat against the aortic wall.
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`Catchings Decl. ¶¶ 33, 34, 37, 39; Norred Decl. ¶¶ 63, 72, 84. This is because the aorta
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`has an irregular, oblong shape and is constantly expanding and contracting. Catchings
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`Decl. ¶ 33; Norred Decl. ¶ 63. A ring member that could not conform to the irregular,
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`oblong shape of the aorta and could not move in tandem with its expansions and
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`contractions would fail to seat or dislodge. Catchings Decl. ¶ 33; Norred Decl. ¶ 63.
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`A ring member that could not seat against the aortic wall could not seal
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`against the root of the native aortic valve. Catchings Decl. ¶¶ 33, 37; Norred Decl. ¶ 63.
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`Sealing against the root of the native aortic valve is vital in order to reduce
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`perivalvular leaks. Catchings Decl. ¶¶ 33, 37; Norred Decl. ¶ 63. A prosthetic aortic valve
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`susceptible to perivalvular leaks would not be acceptable to a person of ordinary skill
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`in the art, because such leaks can lead to heart failure, hemolytic anemia, blood clots,
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`stroke, infective endocarditis and death. Catchings Decl. ¶¶ 33, 37; Norred Decl. ¶ 63.
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`2. No Broadening of Scope
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`As set forth above, the proposed claim 25 is narrower than original claim
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`16 of the ‘228 patent.
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`3. Written Description Support
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`As set forth above, each element of proposed claim 25 is supported in
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`the specification of the ‘228 patent.
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`B.
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`Patentability Over Prior Art
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`1.
`
`Level and Knowledge of Person of Ordinary Skill in the Art
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`
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`A person of ordinary skill in the art would possess a Doctor of Medicine
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`from an accredited medical school plus at least three years of residency in internal
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`medicine or equivalent in surgical residency, plus three years of cardiology fellowship
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`or equivalent in cardiovascular surgery. Catchings Decl. ¶ 3; Norred Decl. ¶ 56.
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`2.
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`Prior Art of Record and Known Prior Art
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`a.
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`Closest Prior Art Known
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`The valve described in Schreck, US 6,454,799, published September 24,
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`2002, Ex. 2098, is the closest prior art known to Patent Owner. Norred Decl. ¶ 76.
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`Schreck features a tissue-engaging base 104, which is comprised of
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`tubular member 140 and commissure and cusp posts 146 and 148, and a separate,
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`wireform-supported leaflet subassembly 102 wrapped in a fabric skirt 110. Schreck,
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`Fig. 6; Norred Decl. ¶ 76. When these components are assembled prior to placement,
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`the fabric skirt 110 drapes around the outside of the tissue-engaging base 104. When
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`this device is placed in the native aortic valve, the tissue-engaging base 104 radially
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`expands into contact with the annulus tissue. The fabric skirt 110 is captured between
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`the tubular member 140 and the annulus tissue to form a flow channel for blood
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`entering the inflow end of the valve. Norred Decl. ¶ 76.
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`Schreck purports to anchor in place through the combination of a
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`tubular member 140, which exerts radial force against the walls of the native aortic
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`valve, and barbs, staples or flanges as necessary. Schreck, 2:16-36, 13:12-31. The
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`immediate problem with this design is that tubular member 140 does not extend into
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`the ascending aorta, even into the area where the new valve is seated (the new valve is
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`seated directly above the “tissue engaging base,” which houses the tubular member).
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`As a result, there is nothing to maintain the new valve against the aortic wall. When
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`the new valve is exposed to the high pressures within the aorta, the posts 146 and 148
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`will cantilever inwardly towards the center of the device. This will pull the tissue-
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`engaging base 104 and fabric skirt 110 away from the aortic wall, causing
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`misalignment of the leaflets 32, perivalvular leaks, and ultimately dislodgment and
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`failure of the device. Catchings Decl. ¶ 47; Norred Decl. ¶ 77.
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`As noted above, perhaps in recognition of the fact that tubular member
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`140 will not be sufficient to anchor the device, Schreck suggests the use of barbs,
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`flanges or staples to provide greater attachment to the host tissue. Schreck, 11:43-47,
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`-9-
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`13:29-31. Each of these structures is designed to pierce or will in fact pierce the
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`delicate tissue of the aortic wall when the device is placed. Norred Decl. ¶¶ 78, 82.
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`Because of the high pressures within the aorta, this could lead to aortic dissection or
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`perforation or to other complications such as infection. As a result, devices
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`employing these structures would not be acceptable to a person of ordinary skill in the
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`art. Moreover, even if barbs, flanges or staples are used, they will not prevent
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`prolapse of the leaflet subassembly 102. Catchings Decl. ¶ 47; Norred Decl. ¶ 77.
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`Schreck is problematic for another reason. In one embodiment of the
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`invention, the leaflets 32 of the valve attach to the commissure posts 42 through
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`loops 70, which are pinched and threaded through axial slots 54. A plurality of inserts
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`72, which are wider than these axial slots, are used to secure the loops to the exterior
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`of the commissure posts as depicted in Figure 4. When pressure is applied to the
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`leaflets 32, these loops will pull against these inserts 72. Over time, the leaflets 32 will
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`tear at this juncture as a result of this direct stress. Also, this pressure may cause the
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`tissue comprising the leaflets 32 to shrink. If this occurs, inserts 72 could dislodge
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`and cause an arterial embolism. Norred Decl. ¶ 79.
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`A person of ordinary skill in the art at the time the application for the
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`‘228 patent was filed would have understood that the means described in Schreck for
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`maintaining a prosthetic valve in the aorta differ substantially from the expanding
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`stent system in proposed claim 25. Norred Decl. ¶ 81.
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`b. Other Known Prior Art
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`Other prior art known to Patent Owner can be placed into four
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`categories: (1) surgically implanted valves; (2) valves anchored in place with barbs,
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`hooks or other sharp protrusions; (3) valves without a stent system that extends into
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`the ascending aorta (“short stent” valves); and (4) valves without a pliable ring
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`member as claimed. Claim 25 is patentable over these patents because none of these
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`prior art references includes a percutaneously-placed prosthetic aortic valve having a
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`ring member with a pliable circumference adapted to seat about an aortic wall
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`surrounding an aortic channel and seal against a root of a native aortic valve upon
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`percutaneous placement, and an expandable stent system extending into the ascending
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`aorta upon percutaneous placement and connected to the ring member.
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`i.
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`Surgically-Implanted “Hancock” Style Valves
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`Hancock, US 3,755,823, published September 4, 1973, Ex. 2100,
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`discloses a rigid stent having apexes interconnected by arms, the apexes being
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`deflectable inwardly upon hemodynamic loading of the heart valve for reducing the
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`stress in the valve tissue, the stent being covered by a cloth sleeve which may have an
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`integral bead or flap for attachment to the heart, padding being provided beneath
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`portions of the sleeve for protection, and a reinforcing ring extending around the
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`assembly over the marginal portions of the heart valve, with sutures extending
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`through the reinforcing ring and tissue of the heart valve for forming an attachment
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`to the stent.
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`Hancock does not disclose, teach or suggest a “ring member having a
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`pliable circumference adapted to seat about an aortic wall surrounding an aortic
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`channel and seal against a root of a native aortic valve upon percutaneous placement,”
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`or “an aortic valve having a collapsed configuration for delivery inside a catheter, and
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`an expanded configuration when deployed from said catheter and percutaneously
`
`placed in the aortic channel to maintain the ring member in the seat about the aortic
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`wall” or “an expandable stent system extending into the ascending aorta” as set forth
`
`in claim 25. Like the device disclosed in Schreck, Hancock discloses no ring member
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`or stent structure for anchoring the ring member.
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`Not long after its introduction, the Hancock valve exhibited major valve-
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`related complications including structural deterioration, tears of one or more cusps
`
`causing cusp prolapse and regurgitation, and valve incompetence. Doctors analyzing
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`the efficacy of the Hancock valve recommended early prophylactic replacement of the
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`valve. Ex. 2128, (Bortaoltti U, Milano A, Guerra F, et al, Failure of Hancock Pericadial
`
`Xenografts: Is Prophylactic Bioprosthetic Replacement Justified? Ann Thorac Surg 1991;
`
`51:430-7).
`
`The following surgically implanted valves are structurally similar to and
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`deficient for the same reasons set forth above for Hancock: Kischer, Ex. 1004;
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`
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`Ionescu, Ex. 2101; Totten, Ex. 2102; Bédard, Ex. 2103; Vince, Ex. 2104; Verely, Ex.
`
`2105; Girard, Ex. 2127; Huynh, Ex. 2106; Gabbay, Ex. 2107; Gabbay, Ex. 2108;
`
`Carpentier, Ex. 2109; Eberhardt, Ex. 2110; and Vesely, Ex. 2111.
`
`ii. Other Surgically-Implanted Valves
`
`Other surgically implanted valves include Ersek, Ex. 2112 (surgically
`
`implanted, no ring member; 3:49-54, Fig. 4); Wolfe, Ex. 1006 (surgically implanted, no pliable
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`ring member; Abstract; Fig. 2A; 1: 60 – 2:4; 3:64-68; 4:19-41); Fenton, Ex. 2113 (surgically
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`implanted, no stent structure; Figs. 1-4B; 5:20 – 6:62); and Shu, Ex. 2114, (rigid surgically-
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`implanted mechanical heart valve; 9:23-34).
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`iii. Percutaneously-Implanted Valves
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`Known percutaneously placed valves fail to disclose, teach, or suggest an
`
`aortic valve is anchored in place by a stent system extending into the ascending aorta
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`exerting a radial force against the aortic wall, without barbs, hooks, sharp protrusions
`
`or sutures, and a pliable ring member that seats and seals upon percutaneous
`
`placement to reduce perivalvular leaks. Catchings Decl. ¶ 45; Norred Decl. ¶ 73. These
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`valves include: Pavcnik, Ex. 2115 (two-piece percutaneously placed valve anchored in place with
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`barbs; Figs. 1 and 6; 4:20-31; 5:1-24); Anderson, Ex. 2116 (no ring member or seal against
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`the root of the aorta; nothing to prevent blood from flowing between and around the loops of the stent;
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`Fig. 2; 7:3-16); Block, Ex. 2117 (inflatable prosthetic valve held in a desired position with pins or
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`hooks; 7:41-56); Leonhardt, Ex. 2099 (no ring member; anchored by adhesive; 3:4-6, 3:27-30,
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`-13-
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`11:37-53, 8:43-54, 8:66-67, 9:1. See also Catchings Decl. ¶ 43, 44); Taheri, Ex. 2118 (no
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`ring member; spikes for anchoring; Figs. 2A and 2B; 2:35-44); Jayaraman, Ex. 2119 (outwardly
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`directed points anchor the valve in the aortic annulus; Abstract; Figs. 3-6, 10-16; 3:5-27, 37-59);
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`Bessler, Ex. 2120 (a plurality of barbs for fixing the heart valve at a desired position; Figs. 6 and
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`7; 4:12-22; 5:6-12; 5:67 – 6:2); Arru, Ex. 2121 (anchored in place with barbs or hooks);
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`Shaolian, Ex. 1005 (prosthetic venous valve for use in low pressure applications; Abstract; Fig. 1;
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`1:7-10; 2:55-60; 3:9-14; 4:34-42; 4:66 –5:2; 5:36-54; 6:27-30; 11:13-36; 12:5-18);
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`Garrison, Ex. 2122 (two-piece valve with a cardiac valve 6 and a valve displacer, no ring member;
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`Abstract; Figs. 3-10, 29 and 30; 4:10-57; 5:30-41; 9:64 – 10:23); DiMatteo, Ex. 1003 (rigid
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`scaffold, no ring member, no stent system; see also Norred Decl. ¶ 83) ; Bailey, Ex. 2123 (anchor
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`flanges 22, which project out from below the native aortic annulus; 8:52-64, 9:61-67, 10:1-24);
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`Figulla, Ex. 2124 (anchored in the aorta with barbs, no ring member); Spiegel, Ex. 2125
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`(anchored in the aorta with barbs, no ring member); and Fraunhofer, Ex. 2126 (anchored in the
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`aorta with barbs, no ring member).
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`
`
`V.
`
`CONCLUSION
`
`A person of ordinary skill in the art would consider the prosthetic aortic
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`valve invented by Dr. Norred, as set forth in claim 25, novel and nonobvious over the
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`prior art discussed above and the general state of the art at the time the application for
`
`the ‘228 patent was filed. Catchings Decl. ¶ 28. The combination of a stent system that
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`anchors the aortic valve in the ascending aorta and a pliable ring member that seats
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`against the aortic wall and seals against the root of the native aortic valve, which is
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`percutaneously placed as set forth in claim 25 is not disclosed, taught or suggested by
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`the prior art.
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`Accordingly, the Patent Owner respectfully requests that the Board grant
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`this Substitute Motion to Amend and substitute claim 25 according to the
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`contingencies specified herein.
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`Respectfully Submitted,
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`/James J. Kernell/
`James J. Kernell, Reg. No. 42720
`ERICKSON KERNELL DERUSSEAU &
`KLEYPAS, LLC
`8900 State Line Road, Suite 500
`Leawood, Kansas 66206
`Telephone: (913) 549-4700
`Facsimile:
`(913) 549-4646
`Email: jjk@kcpatentlaw.com
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`-and-
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`David L. Marcus (pro hac vice)
`BARTLE & MARCUS LLC
`1100 Main Street, Suite 2730
`Kansas City, Missouri 64105
`Telephone: (816) 256-4699
`Facsimile:
`(816) 222-0534
`Email: dmarcus@bmlawkc.com
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`Attorneys for Patent Owner
`Troy R. Norred, M.D.
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`-15-
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`CERTIFICATE OF SERVICE
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`I hereby certify this 1st day of August 2014, that the foregoing
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`Patent Owner Substitute Motion to Amend Pursuant to 37 C.F.R. § 42.121 has been
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`served via Federal Express upon the lead and back-up counsel for the Petitioner,
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`JACK BARUFKA, 1650 Tysons Boulevard, McLean, Virginia 22102; and EVAN
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`FINKEL, 725 South Figeuroa Street, Suite 2700, Los Angeles, California 90017, both
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`of Pillsbury Winthrop Shaw Pittman LLP.
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`/James J. Kernell/
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`-16-
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