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
`____________
`
`Attorney Docket No. 058888-0000014
`
`____________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO AMEND
`
`
`
`
`
`
`
`
`
`____________
`
`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
`____________
`
`Attorney Docket No. 058888-0000014
`
`____________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO AMEND
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I. INTRODUCTION ................................................................................................ 1
`II. THE MOTION SHOULD BE DENIED BECAUSE THE AMENDMENTS
`ENLARGE THE SCOPE OF THE CLAIM AND ARE NOT RESPONSIVE
`TO A GROUND OF UNPATENTABILITY ....................................................... 1
`A. The Embodiments Corresponding to Claim 16 ............................................... 1
`B. Proper Construction of the “Means for Mounting and Moving” .................... 3
`C. By Removing the Means Language, the Amendments Broaden Claim 16 and
`Do Not Respond to Grounds Of Unpatentability ............................................ 5
`III. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILS TO
`PROVIDE CLAIM CONSTRUCTIONS FOR NEW TERMS............................ 6
`IV. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED TO
`SHOW SUPPORT FOR THE SUBSTITUTE CLAIM ....................................... 8
`V. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED TO
`SHOW THE SUBSTITUTE CLAIM IS PATENTABLE ................................... 9
`VI. CONCLUSION .............................................................................................. 15
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT LIST
`
`Exhibit Description
`U.S. Patent 5,469,868 to Reger
`U.S. Patent 6,245,101 to Drasler et al.
`Transcript of October 7, 2014 Deposition of Timothy Titus Catch-
`ings, M.D.
`Transcript of October 8, 2014 Deposition of Troy R. Norred, M.D.
`Transcript of October 9, 2014 Deposition of James J. Kernell
`Corrected Petition (Paper 4) in IPR2014-00111
`Translation of German Patent App. No. DE 195-46-692 to Figulla et
`al. - Application as Filed (with a certification from Abraham I.
`Holczer attesting to the accuracy of the translation) (This is Exhibit
`1006 in IPR2014-00111) (Patent Owner Exhibit 2124 is the file his-
`tory for this patent without any translation)
`German Patent App. No. DE 198-57-887 A1 to Fraunhofer Corpora-
`tion (This is Exhibit 1007 in IPR2014-00111)
`Translation of German Patent App. No. DE 198-57-887 A1 to
`Fraunhofer Corporation (with a certification from Abraham I.
`Holczer attesting to the accuracy of the translation) (This is Exhibit
`1008 in IPR2014-00111) (This is also Patent Owner Exhibit 2126)
`Declaration of Felix Harbsmeier with attached exhibits (1-5). (This
`is Exhibit 1013 in IPR2014-00111)
`Decision Instituting Inter Partes Review in IPR2014-00111 (Paper
`10)
`Expert Declaration of Alexander J. Hill, PhD
`
`“Anatomy of the aortic root: implications for valve-sparing sur-
`gery”, by Efstratios I. Charitos, Hans-Hinrich Sievers, Department
`of Cardiac and Thoracic Vascular Surgery, University of Lübeck,
`Lübeck, Germany, published in the Annals of Cardiothoracic Sur-
`gery, Vol. 2, No 1., pages 53-56 (January 2013)
`
`
`
`
`
`
`ii
`
`Exhibit No.
`1007
`1008
`1009
`
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Athena Automation Ltd. v. Husky Injection Molding Sys. Ltd.,
`IPR2013-00167, Paper 51 at 29 (July 23, 2014) .................................................. 10
`
`BAE Sys. Info. and Elec. Sys. Integration, Inc. v. Cheetah Omni, LLC,
`IPR2013-00175, Paper 45 at 23 (June 19, 2014) ................................................. 11
`
`Beckson Marine, Inc. v. NFM, Inc.,
`144 Fed. Appx. 862 (Fed. Cir. 2005) ..................................................................... 5
`
`Blackberry Corp. v. Mobilemedia Ideas LLC,
`IPR2013-00016, Paper 32 at 16-17 (Feb. 25, 2014) .............................................. 6
`
`Google Inc. v. Jongerius Panoramic Techs., LLC,
`IPR2013-00191, Paper 70, at 63 (Aug. 12, 2014) ............................................... 10
`
`Idle Free Sys., Inc. v. Bergstrom, Inc.,
`IPR2012-00027, Paper 26 at 5 (June 11, 2013) .................................................1, 6
`
`Idle Free Sys., Inc. v. Bergstrom, Inc.,
`IPR2012-00027, Paper No. 66 at 33 (Jan. 7, 2014) ............................................. 10
`
`In re Bigio,
`381 F.3d 1320 (Fed. Cir. 2004) ............................................................................ 15
`
`In re Donaldson Co., Inc.,
`16 F.3d 1189 (Fed. Cir. 1994) ................................................................................ 3
`
`Invensense, Inc. v. STMicroelectronics, Inc.,
`IPR2013-00241, Paper 21 at 4 (Jan. 9, 2014) ........................................................ 8
`
`Toyota Motor Corp. v. American Vehicular Sci. LLC,
`IPR2013-00419, Paper 32 at 5 (Mar. 7, 2014) ....................................................... 7
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) .............................................................................. 8
`
`
`
`
`
`iii
`
`
`
`
`
`Rules and Regulations
`
`Code of Federal Regulations
`Title 37, Section 42.121(a)(2) ................................................................................ 1
`Title 37, Section 42.121(a)(2)(i) ........................................................................1, 7
`Title 37, Section 42.121(b)(1) ................................................................................ 9
`Title 37, Section 42.20(c) ..................................................................................... 11
`
`
`
`
`
`iv
`
`
`
`I.
`
`INTRODUCTION
`
`The motion to amend (Paper 18) should be denied because proposed amend-
`
`ed claim 25 (1) impermissibly enlarges the scope of claim 16, (2) includes amend-
`
`ments that do not respond to grounds for unpatentability, (3) includes terms for
`
`which Norred has not proposed any construction, (4) is not supported by the speci-
`
`fication of U.S. Patent 6,482,228 (Ex. 1001, “the ‘228 patent”), and (5) has not
`
`been shown by Norred to be patentable over the prior art.
`
`II. THE MOTION SHOULD BE DENIED BECAUSE THE AMEND-
`MENTS ENLARGE THE SCOPE OF THE CLAIM AND ARE NOT
`RESPONSIVE TO A GROUND OF UNPATENTABILITY
`A substitute claim may not enlarge in any respect the scope of the chal-
`
`lenged claim that it is intended to replace. 37 C.F.R. §42.121(a)(2); Idle Free Sys.,
`
`Inc. v. Bergstrom, Inc., IPR2012-00027, Paper 26 at 5 (June 11, 2013) (“A patent
`
`owner may not seek to broaden a challenged claim in any respect, in the name of
`
`responding to an alleged ground of unpatentability. A proper substitute claim under
`
`37 C.F.R. §42.121(a)(2)(i) must only narrow the scope of the challenged claim it
`
`replaces.”) As explained below, proposed claim 25 is not responsive to a ground
`
`patentability and instead broadens the scope of claim 16 by replacing the “means
`
`for mounting and moving” with functional language, omitting any recitation of a
`
`structure corresponding to the means-plus-function limitation.
`
`A. The Embodiments Corresponding to Claim 16
`The ‘228 patent describes four embodiments – umbrella valve 30 (Ex. 1001,
`
`
`
`
`
`
`Figs. 6-9, 4:5-52); conical valve 66 (id., Figs. 10-13, 4:53-5:32); trihedral valve 82
`
`(id., Figs. 14-17, 5:33-62); and cadaver/porcine valve 100 (id., Figs. 18-19, 5:63-
`
`6:8). Claim 16 is directed to an “aortic valve” that corresponds to the conical and
`
`trihedral valve embodiments as explained below.
`
`In the umbrella valve embodiment of Figs. 6-9, blood flows around the um-
`
`brella when it is in a folded position; there is no “ring including an aperture for
`
`blood flow therethrough” as required by claim 16. See id., Fig. 6, 4:5-52. In the ca-
`
`daver/porcine embodiment of Figs. 18-19, if you assume that the tissue is a “mem-
`
`brane,” the tissue is a flat surface (leaflets) that opens and closes like the native
`
`valve it replaces; the tissue is not mounted by any structure (“mounting means”)
`
`that mounts “first and second spaced-apart open ends” in “displaced” relation as
`
`required by claim 16. Moreover, there is no such structure (“means”) disclosed for
`
`also “moving said membrane second end between a first open position … and a
`
`second closed position” as also required by claim 16. See id., Figs. 18-19, 5:63-6:8.
`
`This is contrasted with the conical valve and trihedral valve embodiments in
`
`which the membrane (75, 92) has a lower open end and a spaced-apart upper open
`
`end. Both ends are mounted by fingers or arms (68, 84) (“mounting means”) to be
`
`open when the valve is in an open position so that blood may flow through the ring
`
`(72, 86). See id., Figs. 12-13, 16-17. The upper end is closed (but the lower end
`
`remains open) when the valve is in a closed position so that blood cannot flow
`
`
`
`2
`
`
`
`through the ring. See id., Figs. 10-11, 14-15. The fingers or arms (68, 84) mount
`
`and move the membrane between the open and closed positions. See id., Figs. 10-
`
`13, 4:53-5:32; Figs. 14-17, 5:33-62.
`
`B.
`Proper Construction of the “Means for Mounting and Moving”
`Claim 16 recites a “means for mounting said first open end of said mem-
`
`brane about said ring aperture with said second open end displaced therefrom, said
`
`means moving said membrane second end between a first open position to allow a
`
`blood flow therethrough and a second closed position to preclude a blood flow
`
`therethrough.” (Emphasis added). This “means plus function” limitation is to be
`
`interpreted under §112, ¶6 (Decision, Paper 10 at 7) to cover the structures de-
`
`scribed in the specification for performing the claimed functions and equivalents.
`
`In re Donaldson Co., Inc., 16 F.3d 1189, 1193 (Fed. Cir. 1994) (en banc).
`
`In the conical valve embodiment of Figs. 10-13, the “means for mounting
`
`and moving” comprise fingers 68 having a first end hingedly secured to the ring 72
`
`and a free second spaced therefrom. Ex. 1001, 4:54-5:14. “The fingers 68 … are
`
`hingedly secured together by ring 72 extending through the base 74 of each finger
`
`68 and interconnected by … fabric 75 membrane secured to the inside surfaces 69
`
`of the fingers.” Id., 4:56-61. “The fingers 68 extend generally radially inwardly
`
`and away from the base 70.” Id., 4:61-63. “In the closed position (FIGS. 10-11),
`
`the tops 76 of the fingers contact each adjacent fingertip 76 to prevent regurgita-
`
`
`
`3
`
`
`
`tion.” Id., 4:65-67. During systole “[f]ingers 68 pivot on ring 72 and tips 76 sepa-
`
`rate to allow blood to flow through the center of valve 66. …” Id., 5:9-14.
`
`In the trihedral valve embodiment of Figs. 14-17, the “means for mounting
`
`and moving” comprise arms 84 having a first end hingedly attached to the ring 86
`
`and a free second spaced therefrom. Id., 5:33-47. The “[a]rms 84 are hingedly at-
`
`tached to ring 86 of base 88 and extend upwardly and radially inwardly from base
`
`88 to generally form a trihedron or cone.” Id., 5:35-39. “Each rod 84 has a cres-
`
`cent-shaped pad 90 at its free end.” Id., 5:39-40. “A cone-shaped membrane 92 …
`
`is secured to each arm 84 and base 88.” Id., 5:40-42. “During diastole, back flow
`
`of blood from the aorta to the left ventricle causes valve 82 to close preventing re-
`
`gurgitation (FIGS. 14-15).” Id., 5:43-45. “During systole, blood is ejected from the
`
`left ventricle to force valve 82 open and allow blood to flow into the ascending
`
`aorta through the center of valve 82.” Id., 5:45-47.
`
`The structure of the “means for mounting and moving” should therefore be
`
`construed as “fingers or arms hingedly attached or hingedly secured to the ring
`
`member and a free end spaced therefrom” or an equivalent structure. That con-
`
`struction is consistent with dependent claim 17 which states the element includes
`
`“at least one arm having a first end hingedly secured to said ring member and a
`
`free second spaced therefrom.”
`
`In its Decision to Institute Trial, the Board adopted, as “reasonable at this
`
`
`
`4
`
`
`
`stage of the proceeding,” a construction of the “means for mounting and moving”
`
`in terms of the membrane being “hingedly secured” or “hingedly attached” about
`
`the ring aperture. Decision at 10. Petitioner submits that such a construction is in-
`
`complete because while it expresses a function (“hingedly secured” or “hingedly
`
`attached”), it lacks any structure for performing the function.
`
`A case in point is Beckson Marine, Inc. v. NFM, Inc., 144 Fed. Appx. 862
`
`(Fed. Cir. 2005) in which the Federal Circuit held that “means hingedly connecting
`
`said window pane to said mounting flange” must be interpreted under §112, ¶6 be-
`
`cause “[t]he language ‘hingedly connecting’ recites a function, not a particular de-
`
`fined structure.” Id. at 864-865. The phrase “does not recite limited and definable
`
`structure performing the function of ‘hingedly connecting.’” Id. at 866. “In light of
`
`this disclosure, the district court properly construed the limitation ‘means hingedly
`
`connecting’ to require ‘a windowpane connected to a mounting flange using hinge
`
`lugs pivotally secured to cooperable lugs b[y] means of a hinge pin, thus allowing
`
`the window to open and shut by pivoting about a hinge,” and equivalents. Id.
`
`Under Beckson Marine, the subject limitation should not be construed using
`
`only functional language, such as “hingedly attached” or “hingedly secured,” but
`
`instead must include the structure (fingers or arms) for doing so.
`
`C. By Removing the Means Language, the Amendments Broaden
`Claim 16 and Do Not Respond to Grounds Of Unpatentability
`
`Norred’s claim 25 eliminates the “means for mounting and moving” from
`
`
`
`5
`
`
`
`claim 16 and replaces it with purely functional language - “membrane hingedly se-
`
`cured about said aperture of said ring member.” That change broadens the claim by
`
`eliminating the structures corresponding to the means element - “fingers or arms
`
`hingedly attached or hingedly secured to the ring member and a free end spaced
`
`therefrom.” Hence, substitute claim 25 should be rejected. See, e.g., Blackberry
`
`Corp. v. Mobilemedia Ideas LLC, IPR2013-00016, Paper 32 at 16-17 (Feb. 25,
`
`2014) (amendment rejected because means element replaced with structures differ-
`
`ent than those corresponding to the means element as construed by the Board).
`
`Because Norred’s substitute claim 25 would broaden the scope of claim 16,
`
`the amendment does not respond to a ground of unpatentability and should be re-
`
`jected. 37 C.F.R. §42.121(a)(2)(i); see also Idle Free, Paper 26 at 5 (“A patent
`
`owner may not seek to broaden a challenged claim in any respect, in the name of
`
`responding to an alleged ground of unpatentability.”). That the amendment does
`
`not respond to a ground of unpatentability is self-evident from the fact that in his
`
`motion, Norred does not consider whether a prior art reference may satisfy the
`
`“means for mounting and moving” limitation in claim 16, but not the language
`
`Norred seeks to substitute for that means element in proposed claim 25.
`
`III. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILS
`TO PROVIDE CLAIM CONSTRUCTIONS FOR NEW TERMS
`
`“If there is any new term used in a proposed substitute claim, the meaning of
`
`which reasonably can be anticipated as subject to dispute, the patent owner should
`
`
`
`6
`
`
`
`provide a proposed claim construction in the motion to amend.” Toyota Motor
`
`Corp. v. American Vehicular Sci. LLC, IPR2013-00419, Paper 32 at 5 (Mar. 7,
`
`2014). Here, however, Norred fails to provide the constructions for any of the new
`
`terms added for the first time in proposed claim 25. Since Norred argues that these
`
`terms reflect features that a skilled artisan would consider “highly significant in
`
`terms of patient care” (Motion at 5), it is reasonable to anticipate that the meaning
`
`of the terms would be subject to dispute.
`
`By way of example only, consider the term “pliable.” At his deposition, Dr.
`
`Norred was asked for his “understanding of the word pliable as you used it in your
`
`patent.” Ex. 1010 (Norred Tr.), 84:22-24. All Dr. Norred could offer was that “my
`
`definition of pliability would be a system that conforms to the geography within
`
`the area that it is going to be exposed to.” Id., 85:1-5. On the other hand, Norred’s
`
`supposed expert, Dr. Catchings, gave a convoluted definition of the term “pliable,”
`
`testifying in one answer that “the term pliable is not relative,” “[a]s it pertains to a
`
`certain element, it is relative,” “pliable is an absolute term,” “but an item may be
`
`pliable in this instance, it may not be pliable in another instance,” but “I think the
`
`term is absolute.” Ex. 1009 (Catchings Tr.), 113:3-10.
`
`The failure to offer a concrete definition of “pliable” as used in the amended
`
`claim is crucial. Dr. Catchings conceded that “superelastic material is pliable.”
`
`Catchings Tr., 195:8-10. DiMatteo (Ex. 1003) discloses a tubular stent including
`
`
`
`7
`
`
`
`support trellis 24 (ring member), positioned over liner 82, that may be formed from
`
`biocompatible, “[s]haped memory alloys having superelastic properties.” Ex. 1003,
`
`8:60-67, 12:47, 15:7-16:2. Thus, Norred’s contention that DiMatteo’s ring member
`
`“is not and cannot be pliable” (Response, Paper 15 at 35), is at odds with Dr.
`
`Catchings’ definition of “pliable.”
`
`IV. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED
`TO SHOW SUPPORT FOR THE SUBSTITUTE CLAIM
`
`“A motion to amend claims must clearly identify the written description
`
`support for the proposed substitute claims.” Invensense, Inc. v. STMicroelectron-
`
`ics, Inc., IPR2013-00241, Paper 21 at 4 (Jan. 9, 2014); see also 37 C.F.R.
`
`§42.121(b)(1). Norred has not met his burden here with respect to at least the last
`
`clause of proposed substitute claim 25 regarding deployment of the stent system.
`
`Stents that are placed percutaneously are generally classified as either bal-
`
`loon-expanding or self-expanding. See Ex. 1008 (U.S. 6,245,101 to Drasler et al.),
`
`1:18-67. Norred has crafted his substitute claim using language presumably intend-
`
`ed to encompass balloon-expandable and self-expanding stents. However, Norred
`
`has not and cannot identify any support in the ‘228 patent for a claim that covers a
`
`self-expanding stent, as the patent only discloses use of balloon-expandable stents.
`
`See Ex. 1001, Fig. 3, 2:61-3:10. This is an additional reason that the motion to
`
`amend should be rejected. See, e.g.,Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159-60
`
`(Fed. Cir. 1998) (no support for broad claim referring to “cup” of hip implant
`
`
`
`8
`
`
`
`without reciting its “conical shape” as disclosed in patent).
`
`Moreover, while the ‘228 patent describes a valve (30, 66, 82, 100) and a
`
`stent system 28, all the claims are directed to “[a]n aortic valve” alone, and not to a
`
`valve/stent combination. By adding limitations regarding the stent system to the
`
`body of proposed claim 25, the claim becomes indefinite in that the preamble lim-
`
`its the claim to “an aortic valve” but the claim body introduces the separate stent
`
`system. In proposed claim 25, Norred tries to camouflage this issue by referring to
`
`the collapsed and expanded configurations of the “aortic valve” during placement
`
`and deployment, respectively, when the patent discloses such configurations only
`
`for the stent system and not the valve. See, e.g., Ex. 1001, 2:61-67 (“The stent sys-
`
`tem 28 is initially collapsed to a small diameter around an angioplasty balloon
`
`29 … When the valve/stent combination 36 is correctly placed, the balloon 29 is
`
`inflated to expand the stent scaffolding 28 …”) (emphasis added). This is another
`
`reason that the amended claim language is not supported by the disclosure.
`
`The motion to amend should therefore be denied because Norred has not met
`
`its burden to clearly identify support for the proposed substitute claim.
`
`V. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED
`TO SHOW THE SUBSTITUTE CLAIM IS PATENTABLE
`
`The “[patent owner] bears the burden of proof in demonstrating patentability
`
`of the proposed substitute claims over the prior art in general, and thus entitlement
`
`to add these proposed substitute claims to its patent.” Idle Free, Paper No. 66 at 33
`
`
`
`9
`
`
`
`(Jan. 7, 2014); see also 37 C.F.R. §42.20(c). Norred has failed to meet his burden.
`
`Norred does not even consider whether the proposed claim is obvious over
`
`any of the known percutaneously placed valves including for example Figulla (Ex.
`
`1013), Fraunhofer (Ex. 1015, 2126), Schreck (Ex. 2098), and DiMatteo (Ex. 1003),
`
`either alone or in combination with any other prior art. See Motion at 8-10, 13-14.
`
`Indeed, the word “obvious” (and variations thereof) is used only once in the mo-
`
`tion, and that single reference is in the conclusion. See Motion at 14. That is fatal
`
`to the motion. See, e.g., Athena Automation Ltd. v. Husky Injection Molding Sys.
`
`Ltd., IPR2013-00167, Paper 51 at 29 (July 23, 2014) (denying motion to amend for
`
`failing to “direct us to evidence that the proposed claim is not obvious over Queré
`
`either alone or in combination with any of the prior art.”); Google Inc. v. Jongerius
`
`Panoramic Techs., LLC, IPR2013-00191, Paper 70, at 63 (Aug. 12, 2014) (denying
`
`motion for failing to “explain adequately why one of ordinary skill in the art would
`
`not have combined the technical disclosures that are the closest prior art as to each
`
`of the claim features to arrive at the claimed invention.”)
`
`The declarations submitted by Norred also do not address obviousness. See,
`
`e.g., Ex. 2093 (Norred Decl.) (token reference to obviousness in ¶30); Ex. 2095
`
`(Catchings Decl.) (no reference to obviousness). But even if the declarations ex-
`
`plored obviousness that would be insufficient because a patent owner cannot make
`
`its case within the declaration alone; the argument must be fully developed and
`
`
`
`10
`
`
`
`presented in the moving papers. See BAE Sys. Info. and Elec. Sys. Integration, Inc.
`
`v. Cheetah Omni, LLC, IPR2013-00175, Paper 45 at 23 (June 19, 2014).
`
`To further demonstrate the failure of Norred to properly consider the obvi-
`
`ousness issue, let us focus attention on four “[k]nown percutaneously placed
`
`valves,” Figulla (Ex. 1013), Fraunhofer (Ex. 1015, 2126), Schreck (Ex. 2098), and
`
`DiMatteo (Ex. 1003). See Motion at 8-10, 13-14.
`
`In its decision, the Board concluded, “Upon review of Medtronic’s analysis
`
`and the evidence of record, we determine that Medtronic has demonstrated that
`
`there is a reasonable likelihood that it would prevail in showing that DiMatteo an-
`
`ticipates claims 16-19 of the ’228 patent.” Paper 10 at 12. In Norred’s motion, the
`
`only reference to DiMatteo is, “DiMatteo, Ex. 1003 (rigid scaffold, no ring mem-
`
`ber, no stent system; see also Norred Decl. ¶83).” Motion at 14. Then, in his decla-
`
`ration, Norred adds that while DiMatteo’s design “may work in venous applica-
`
`tions, it cannot work within the aorta” (Norred Decl., ¶70) and in DiMatteo the
`
`“valve and stent … are a single, integrated structure” (id., ¶83). Norred’s terse,
`
`staccato comments are unintelligible and at odds with the facts.
`
`DiMatteo explicitly states that “the present invention relates to implanta-
`
`ble … aortic … valves” (Ex. 1003, 1:4-7), and discloses embodiments of “a pros-
`
`thetic bicuspid valve 210 … as a replacement aortic valve” (id., 14:50-58). In its
`
`Decision, the Board rejected Norred’s argument that DiMatteo does not disclose a
`
`
`
`11
`
`
`
`“ring member.” Decision at 12. Norred’s statements that DiMatteo has “no stent
`
`system” but has an integrated “valve and stent” cannot be reconciled. DiMatteo in
`
`fact discloses a stent. See Ex. 1003, Fig. 17, 13:43-51 (second-radially collapsible
`
`scaffold 150); see also Paper 4 at Appendix-5 (second scaffold 150). There is no
`
`claim limitation that the stent and valve cannot be an “integrated structure” (what-
`
`ever that means). The ring member within scaffold 30 of trellis 24 is made of
`
`“[s]haped memory alloys having superelastic properties.” Ex. 1003, 7:24-28, 8:60-
`
`67; see also Paper 4 at Appendix-5. Dr. Catchings conceded that “super elastic ma-
`
`terial is pliable.” Catchings Tr., 195:8-10. Thus, to the extent the few terms in
`
`Norred’s parenthetical can be understood to assert purported differences between
`
`DiMatteo and proposed claim 25, the differences in point of fact do not exist.
`
`Figulla discloses a “[s]elf-expanding [pig] heart-valve prosthesis for implan-
`
`tation into the human body and introduction by means of a catheter system” (Ex.
`
`1013 at 8-9), with a stent that includes a ring member that “is anchored in the aorta
`
`wall, so that a constant, tight fit of the heart-valve stent configuration is possible.
`
`See Ex. 1012, Appendix A-2 at 5-7; see also Ex. 1013 at 9, Fig. 4. Likewise,
`
`Fraunhofer discloses a self-expanding swine heart-valve prosthesis that includes
`
`“sealing and fastening ring 1” “in contact with the inner wall of the aorta.” See Ex.
`
`2126, 2:1-10, 3:31, 3:41-43, 4:12-13, 27-34, 43-44; 5: 29-31; Ex. 1012, Appendix
`
`A-3 at 9-7.
`
`
`
`12
`
`
`
`Schreck discloses a self-expandable and balloon-expandable prosthetic aor-
`
`tic valve. Ex. 2098, 4:40-46, 5:37-58, 6:54-65, 8:43-46, 11:47-50, 12:7-11, 12:24-
`
`31; Ex. 1017 at 12. Referring to Figure 6, “a tissue engagement ring” includes
`
`“[w]ireform 106 and skirt 110 of subassembly 102.” Ex. 1017 at 13, citing Ex.
`
`2098, 9:5-6. Wireform is an “elastic wireform 106 [that] may be formed from a bi-
`
`ocompatible polymer” and, “therefore, the term ‘wire’ in wireform should not be
`
`construed as limiting the material to metallic.” Ex. 2098, 9:11-30.
`
`Norred tries to distinguish Figulla, Fraunhofer, and Schreck with cursory
`
`statements about the stents therein including barbs or the like on its outside to fur-
`
`ther anchor the stent in place. See Motion at 9-10, 13; Norred Decl., ¶¶69, 73, 78.
`
`But that is immaterial because neither substitute claim 25, nor the ‘228 patent spec-
`
`ification, exclude the use of barbs. Moreover, Schreck does not require barbs; in-
`
`stead the barbs are optional. Ex. 2098, 13:29-31 (“the tubular member 140 may in-
`
`clude staples or barbs or other such attachment structure for securely locating the
`
`valve 100 within the annulus 206”) (emphasis added).
`
`Norred asserts that Schreck is deployed at the location of the native aortic
`
`valve and does not extend into the ascending aorta. Motion at 9-10; Norred Decl.,
`
`¶¶69, 73. That is irrelevant because substitute claim 25 as written only requires that
`
`the “aortic valve … [be] percutaneously placed in the aortic channel.” That “limita-
`
`tion” is satisfied by Schreck in which “the expandable valves … [are] delivered in-
`
`
`
`13
`
`
`
`to proximity of the aortic annulus 206.” Ex. 2098, 12:20-24, Fig, 16A; see also Ex.
`
`2098, 12:7-8 (“There are a number of ways to deliver the valve 100 to the aortic
`
`annulus”). Moreover, Norred makes no effort to demonstrate why it would not
`
`have been obvious to deploy the self-expanding stent of Schreck in the ascending
`
`aorta as disclosed in other references, such as Figulla. See Ex. 1013, Fig. 4.
`
`Finally, Norred argues that the Figulla and Fraunhofer devices lack a ring to
`
`seal the device against the root of the native aortic valve to reduce perivalvular
`
`leaks. See Motion at 13, Norred Decl., ¶¶69, 73. Norred is wrong. The “constant,
`
`tight fit,” “contact with the inner wall of the aorta,” “secure hold,” and “tightness,”
`
`provided by the ring members of the Figulla and Fraunhofer devices, will neces-
`
`sarily reduce perivalvular leaks and would necessarily require some degree of plia-
`
`bility. See Ex. 1012, Appendix-5 to Appendix-7; see also Ex. 1013 at 9 and Fig. 4;
`
`Ex. 2126, 2:46 – 3:3.
`
`Regarding the issue of “pliability,” Norred has not demonstrated that it
`
`would not have been obvious to make pliable the sealing rings in any of the prior
`
`art references in view of: (1) Norred concedes that a skilled artisan “would have
`
`understood and appreciated the value of a design feature capable of reducing
`
`perivalvular leaks.” Ex. 2093, ¶72. (2) Norred’s “solution” was to use a “pliable,
`
`biocompatible ring member” that conforms to the shape of the aortic wall. Id. (3)
`
`Numerous prior art references disclose stent rings made of pliable material to con-
`
`
`
`14
`
`
`
`form to the shape of the vessel to create a tight fit that avoids perivalvular leaks.
`
`See Ex. 2102, 4:8-18 (“ring [28] is sufficiently pliable as to conform to irregular
`
`openings but will assure a snug fit and seal with the wall of the annulus to which it
`
`is secured.”); Ex. 1007, Abstract (prosthetic aortic heart valve with ring including
`
`“circumferentially disposed compressible and expandable material which provides
`
`a pliable, compliant interface between the valve and the natural valve annulus at
`
`the implanting site.”). While Norred discounted as irrelevant prior art regarding
`
`pliable rings to anchor a stent that is inserted surgically (Norred Tr., 73:18-74:4),
`
`such prior art must be considered because it is from the same field of endeavor as
`
`the ‘228 patent (prosthetic valves), and is reasonably pertinent to the particular
`
`problem with which Norred was involved (making a ring that would seat/seal
`
`about the vessel wall). See In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
`
`Norred has not demonstrated that substitute claim 25 is patentable over the
`
`foregoing references, alone or in combination with other prior art.
`
`VI. CONCLUSION
`In view of the above, Petitioner requests that Patent Owner’s Substitute Mo-
`
`tion to Amend be denied and that the Board reject proposed substitute claim 25.
`
` Respectfully submitted,
`
`Date: October 24, 2014
`
` PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/Jack Barufka/
`Jack S. Barufka, Reg. No. 37,087
`Tel. No. 703.770.7712; Fax No. 703.905.2500
`
`
`
`15
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that the foregoing “Petitioner’s Opposition To Patent Own-
`
`er’s Motion To Amend” was served electronically through the Patent Trial and
`
`Appeal Board’s Patent Review Processing System (PRPS) this 24th day of Octo-
`
`ber, 2014 upon the lead and back-up counsel for the Patent Owner:
`
`David Marcus
`Bartle & Marcus LLC
`1100 Main Street, Suite 2730
`Kansas City, MO 64105
`
`
`
`
`
`James J. Kernell
`Erickson Kernell Derusseau & Kleypas, LLC
`8900 State Line Road, Suite 500
`Leawood, KS 66206
`
`
`
` Respectfully submitted,
`
`Date: October 24, 2014
`
` PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/Jack Barufka/
`
`Jack S. Barufka
`Reg. No. 37,087
`Tel. No. 703.770.7712
`Fax No. 703.905.2500
`
`
`
`
`
`
`
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