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 IPR2014-00395
`Patent 6,482,228
`____________
`
`Attorney Docket No. 058888-0000019
`
`____________
`
`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 IPR2014-00395
`Patent 6,482,228
`____________
`
`Attorney Docket No. 058888-0000019
`
`____________
`
`PETITIONER’S OPPOSITION TO
`PATENT OWNER’S MOTION TO AMEND
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`II.
`
`INTRODUCTION ........................................................................................... 1
`THE AMENDMENTS ENLARGE THE SCOPE OF THE CLAIMS AND
`DO NOT RESPOND TO GROUNDS FOR UNPATENTABILITY ............. 1
`A.
`The Relevant Embodiments .................................................................. 2
`B.
`Proper Construction of the Means-Plus-Function Limitations ............. 3
`C.
`Removing the Means Language Broadens the Scope of the Claims and
`Does Not Respond to Grounds Of Unpatentability .............................. 6
`III. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILS TO
`PROVIDE CLAIM CONSTRUCTIONS FOR NEW TERMS ...................... 8
`IV. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED TO
`SHOW SUPPORT FOR THE SUBSTITUTE CLAIM .................................. 9
`THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED TO
`SHOW THE SUBSTITUTE CLAIMS ARE PATENTABLE ..................... 11
`VI. CONCLUSION .............................................................................................. 15
`
`V.
`
`
`
`
`
`
`
`
`
`
`
`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
`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)
`Corrected Petition (Paper 4) in IPR2014-00111
`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 2327)
`Decision Instituting Inter Partes Review in IPR2014-00111 (Paper
`10)
`
`Exhibit No.
`1021
`1022
`1023
`
`1024
`1025
`1026
`
`1027
`
`1028
`1029
`
`1030
`
`1031
`
`
`
`
`
`ii
`
`
`
`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`Cases
`
`Athena Automation Ltd. v. Husky Injection Molding Sys. Ltd.,
`IPR2013-00167, Paper 51 (July 23, 2014)........................................................... 11
`
`BAE Sys. Info. and Elec. Sys. Integration, Inc. v. Cheetah Omni, LLC,
`IPR2013-00175, Paper 45 (June 19, 2014) .......................................................... 12
`
`Beckson Marine, Inc. v. NFM, Inc.,
`144 Fed. Appx. 862 (Fed. Cir. 2005) ..................................................................... 5
`
`Blackberry Corp. v. Mobilemedia Ideas LLC,
`IPR2013-00016, Paper 32 (Feb. 25, 2014) ............................................................ 7
`
`Google Inc. v. Jongerius Panoramic Techs., LLC,
`IPR2013-00191, Paper 70 (Aug. 12, 2014) ......................................................... 12
`
`Idle Free Sys., Inc. v. Bergstrom, Inc.,
`IPR2012-00027, Paper No. 66 (Jan. 7, 2014) ...................................................... 11
`
`Idle Free Sys., Inc. v. Bergstrom, Inc.,
`IPR2012-00027, Paper 26 (June 11, 2013) ........................................................1, 8
`
`In re Bigio,
`381 F.3d 1320 (Fed. Cir. 2004) ............................................................................ 15
`
`In re Donaldson Co., Inc.,
`16 F.3d 1189 (Fed. Cir. 1994) ............................................................................4, 5
`
`Invensense, Inc. v. STMicroelectronics, Inc.,
`IPR2013-00241, Paper 21 at 4 (Jan. 9, 2014) ........................................................ 9
`
`Laitram Corp. v. Rexnord, Inc.,
`939 F.2d 1533, 1538 (Fed. Cir. 1991) .................................................................... 4
`
`Toyota Motor Corp. v. American Vehicular Sci. LLC,
`IPR2013-00419, Paper 32 (Mar. 7, 2014) .............................................................. 8
`
`Tronzo v. Biomet, Inc.,
`156 F.3d 1154 (Fed. Cir. 1998) ............................................................................ 10
`
`
`
`iii
`
`
`
`
`
`Statutes and Codes
`
`United States Code
`Title 35, Section 112 .............................................................................................. 5
`
`Rules and Regulations
`
`Code of Federal Regulations
`Title 37, Section 42.121(a)(2) ................................................................................ 1
`
`Code of Federal Regulations
`Title 37, Section 42.121(a)(2)(i) ........................................................................1, 8
`
`Code of Federal Regulations
`Title 37, Section 42.121(b)(1) ................................................................................ 9
`
`Code of Federal Regulations
`Title 37, Section 42.20(c) ..................................................................................... 11
`
`
`
`
`
`iv
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Norred’s motion to amend (Paper 17) conditionally requests that proposed
`
`amended claim 25 be substituted for claims 16 and 20, and that proposed amended
`
`claim 26 be substituted for claim 19.1 Norred’s motion should be denied because
`
`the substitute claims (1) impermissibly enlarge the scope of the claims they re-
`
`place, (2) do not respond to grounds for unpatentability, (3) include terms for
`
`which Norred has not proposed any construction, and (4) have not been shown by
`
`Norred to be patentable over the prior art. Further, substitute claim 25 is not sup-
`
`ported by the specification of U.S. Patent 6,482,228 (Ex. 1001, “the ‘228 patent”).
`
`II. THE AMENDMENTS ENLARGE THE SCOPE OF THE CLAIMS
`AND DO NOT RESPOND TO GROUNDS FOR 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
`
`
`1 Section I of the Motion erroneously states that proposed claim 26 is a substitute
`
`for original claim 24 (Mot. at 1) when it is clear from the entirety of the Motion
`
`that claim 26 is a substitute for original claim 19.
`
`
`
`
`
`
`
`replaces.”) As explained below, the substitute claims are not responsive to a
`
`ground for unpatentability and instead broaden claims 16, 19, and 20 by eliminat-
`
`ing means-plus-function limitations (i.e., “means for mounting and moving” of
`
`claim 16 and “means for maintaining” of claims 19 and 20).
`
`A. The Relevant Embodiments
`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). As explained below, the “aortic valve” of claim 16 (and dependent claim 19)
`
`corresponds to the conical and trihedral valve embodiments, while the aortic valve
`
`of claim 20 corresponds to the cadaver/porcine embodiment.
`
`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 claims 16 and 20. See id., Fig. 6, 4:5-52.
`
`In the cadaver/porcine embodiment of Figs. 18-19, if you assume that the
`
`tissue is a “membrane,” 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
`
`
`
`2
`
`
`
`
`
`open position … and a second closed position” as also required by claim 16. See
`
`id., Figs. 18-19, 5:63-6:8. Since claim 20 is directed to an aortic “tissue valve hav-
`
`ing an interior member made of a tissue material” it is clear that it corresponds to
`
`the cadaver/porcine valve 100 embodiment. See Ex. 1001, 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
`
`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. Thus, claim 16 (and dependent claim 19) cor-
`
`responds to the conical and trihedral valve embodiments.
`
`B.
`Proper Construction of the Means-Plus-Function Limitations
`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
`
`
`
`3
`
`
`
`
`
`interpreted under §112, ¶6 (Bd. Dec. (Paper 13) at 10-11) to cover the structures
`
`described in the specification for performing the claimed functions and equiva-
`
`lents. 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 end spaced therefrom; similarly for the trihedral valve embodi-
`
`ment of Figs. 14-17, the “means” comprise arms 84 having a first end hingedly at-
`
`tached to the ring 86 and a free second end spaced therefrom. Ex. 1001, 4:54-5:14,
`
`5:33-47. Thus, the “means for mounting and moving” are “fingers or arms
`
`hingedly attached or hingedly secured to the ring member and a free end
`
`spaced therefrom” or an equivalent structure. Such construction is consistent with
`
`dependent claim 17 which recites “at least one arm having a first end hingedly se-
`
`cured to said ring member and a free end spaced therefrom.” See Laitram Corp. v.
`
`Rexnord, Inc., 939 F.2d 1533, 1538 (Fed. Cir. 1991) (Claim differentiation cannot
`
`be used to more broadly construe a properly interpreted means-plus-function
`
`claim.)
`
`In its Decision to Institute Trial, the Board adopted, as “reasonable at this
`
`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. Bd. Dec. at 11. Petitioner submits that such a construction is in-
`
`
`
`4
`
`
`
`
`
`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. Un-
`
`der Beckson Marine, the subject limitation should not be construed using only
`
`functional language, such as “hingedly attached” or “hingedly secured,” but in-
`
`stead must include the structure (fingers or arms) for doing so.
`
`Claims 19 and 20 recite a “means for maintaining said ring member in said
`
`[“seated position” or “seat”] about the aortic wall.” There is no dispute that this is
`
`also a “means plus function” limitation subject to 35 U.S.C. §112, ¶6 and should
`
`be construed to cover the structure described in the specification for performing the
`
`claimed function and its equivalents. See Bd. Dec. at 11-12; In re Donaldson, 16
`
`
`
`5
`
`
`
`
`
`F.3d at 1193. The Board rejected Norred’s argument that the “means for maintain-
`
`ing” is simply the stent system 28 and concluded that the “means for maintaining”
`
`instead comprises “rods 104 interacting with stent 28” (see Fig. 18) and equiva-
`
`lents. Bd. Dec. at 11-13.2 The “means for maintaining” therefore includes rods 104
`
`that are part of the valve, and are separate and distinct from stent 28 with its “series
`
`of interconnected rods.”3 Claims 19 and 20 therefore require a ring member 102
`
`and rods 104 for connecting the ring member to the stent system 28.
`
`C. Removing the Means Language Broadens the Scope of the Claims
`and Does Not Respond to Grounds Of Unpatentability
`
`Norred proposes claim 25 as a substitute for claims 16 and 20. Amended
`
`claim 25 completely omits the “means for mounting and moving” limitation from
`
`claim 16 thereby eliminating the corresponding structure from the amended claim
`
`(i.e., fingers or arms hingedly attached or hingedly secured to the ring member).
`
`
`2 A more precise construction is “rods 104 to interact with stent 28” because the
`
`claims are directed to the “aortic valve” and not a valve/stent combination.
`
`3 The patent discloses two types of “rods,” rods that are part of the stent and rods
`
`that are part of the valve: “stent system 28 is made up of a small slotted stainless
`
`steel tube or series of interconnected rods, which form an expandable cylindrical
`
`lattice or scaffolding” (Ex. 1001, 2:61-63); and “rods 104 which are connected to
`
`the ascending aortic stents 28” (id., 6:4-6). See also Bd. Dec. at 11-13.
`
`
`
`6
`
`
`
`
`
`Thus, amended claim 25 is broader than claim 16 which it replaces.
`
`Amended claim 25 strikes the “means for maintaining” limitation from
`
`claim 20 and replaces it with “a stent having a plurality of interconnected rods.”
`
`Similarly, Norred proposes claim 26, which replaces the “means for maintaining”
`
`limitation from claim 19 with language regarding a “stent system.” These amend-
`
`ments substantially broaden claims 19 and 20. The “means for maintaining,” as
`
`construed by the Board, includes more than a “stent system” or “a stent having a
`
`plurality of interconnected rods.” That was the construction proposed by Norred
`
`and rejected by the Board. Rather, the “means for maintaining” requires the fol-
`
`lowing structure or an equivalent: (1) interconnecting rods 104 of the valve that in-
`
`teract with (2) the stent system 28 that includes a series of interconnected rods
`
`which form an expandable cylindrical lattice or scaffolding. Thus, the amend-
`
`ments broaden the claims by eliminating interconnecting rods 104 from the claim.
`
`Substitute claims 25 and 26 are thus considerably broader than original
`
`claims 16, 19, and 20, because a device that lacks a “means for mounting and mov-
`
`ing” as recited in claim 16 and lacks interconnecting rods 104 that interact with
`
`stent system 28 as required by claims 19 and 20, may fall within the scope of the
`
`substitute claims but would be outside the scope of all the original claims. See, e.g.,
`
`Blackberry Corp. v. Mobilemedia Ideas LLC, IPR2013-00016, Paper 32 at 16-17
`
`(Feb. 25, 2014) (amendment rejected because the means-plus-function language
`
`
`
`7
`
`
`
`
`
`was replaced with recitation of structures different than those corresponding to the
`
`means as construed by the Board).
`
`Because Norred’s substitute claims 25 and 26 would broaden the scope of
`
`the claims they replace, the amendments do not respond to a ground of unpatenta-
`
`bility and should be rejected. 37 C.F.R. §42.121(a)(2)(i); see also Idle Free, Paper
`
`26 at 5. That the amendments do not respond to a ground of unpatentability is con-
`
`firmed by Norred’s failure to address the impact of eliminating the means plus
`
`function language on the patentability of the claims over Leonhardt or Bailey.
`
`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
`
`provide a proposed claim construction in the motion to amend.” Toyota Motor
`
`Corp. v. Am. Vehicular Sci. LLC, IPR2013-00419, Paper 32 at 5 (Mar. 7, 2014).
`
`Norred, however, fails to provide constructions for any of the new terms added in
`
`his substitute claims. Norred argues that these terms reflect features a skilled arti-
`
`san would consider “highly significant in terms of patient care” (Mot. at 6), thus it
`
`is reasonable to anticipate that their meaning 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. 1024 (Norred Tr.), 84:22-24. All Dr. Norred could offer was that “my
`
`
`
`8
`
`
`
`
`
`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. 1023 (Catchings Tr.), 113:3-10.
`
`The failure to offer a concrete definition of “pliable” as used in the substitute
`
`claim is crucial. Dr. Catchings concedes that a “superelastic material is pliable.”
`
`Catchings Tr., 195:8-10. DiMatteo discloses a tubular stent including support trel-
`
`lis 24 (ring member), positioned over liner 82, that may be formed from biocom-
`
`patible, “[s]haped memory alloys having superelastic properties.” Ex. 2325, 4:22-
`
`34; 8:60-67, 12:47, 15:7-16:2. Thus, Norred’s contention that DiMatteo’s ring
`
`member “is not and cannot be pliable,” is at odds with Dr. Catchings’ definition of
`
`“pliable.” See IPR2014-00110, Paper 15 (Response) at 35.
`
`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
`
`
`
`9
`
`
`
`
`
`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. 1022 (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
`
`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 substitute 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 substitute 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-
`
`
`
`10
`
`
`
`
`
`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 claims.
`
`V. THE MOTION SHOULD BE DENIED BECAUSE NORRED FAILED
`TO SHOW THE SUBSTITUTE CLAIMS ARE 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
`
`(Jan. 7, 2014); see also 37 C.F.R. §42.20(c). Norred has failed to meet his burden.
`
`Norred does not consider whether the proposed claims are obvious over any
`
`of the known percutaneously placed valves including for example Figulla (Ex.
`
`1008), Fraunhofer (Ex. 2327), and Schreck (Ex. 2299), either alone or in combina-
`
`tion with any other prior art. See Mot. at 9-11, 14-15. Indeed, the word “obvious”
`
`(and its variations) is used only in the motion’s brief conclusion. See Mot. at 15.
`
`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.
`
`
`
`11
`
`
`
`
`
`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. 2293 (Norred Decl.) (token reference to obviousness in ¶30); Ex. 2295
`
`(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
`
`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 Norred’s failure to properly consider obviousness, let
`
`us focus on three “[k]nown percutaneously placed valves,” Figulla, Fraunhofer,
`
`and Schreck. See Mot. at 9-11, 14-15. Regarding Figulla and Fraunhofer, all
`
`Norred offers are conclusory statements that the devices disclosed therein are an-
`
`chored in the aorta with barbs and lack a ring member to seal the device against the
`
`root of the native aortic valve to reduce perivalvular leaks. See Mot. at 14-15;
`
`Norred Decl., ¶¶ 69, 73. Those statements are grossly insufficient to demonstrate
`
`the patentability of substitute claims 25 and 26 as explained below.
`
`Figulla discloses a “[s]elf-expanding [pig] heart-valve prosthesis for implan-
`
`
`
`12
`
`
`
`
`
`tation into the human body and introduction by means of a catheter system” (Ex.
`
`1008 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.”
`
`Ex. 1028, Appendix A-2 at 5-7; see also Ex. 1008 at 9, Fig. 4. Likewise, Fraunho-
`
`fer discloses a self-expanding swine heart-valve prosthesis that includes “sealing
`
`and fastening ring 1” “in contact with the inner wall of the aorta.” Ex. 2327, 2:1-
`
`10, 2:46-3:43, 4:6-13, 27-34, 43-44; 5: 29-31; Ex. 1028, Appendix A-3 at 9-7.
`
`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 Mot. at 9-10, 13-15; Norred Decl., ¶¶69, 73, 78.
`
`But that is immaterial because neither substitute claims 25 and 26, nor the ‘228 pa-
`
`tent specification, exclude the use of barbs. Moreover, Schreck does not require
`
`barbs; instead the barbs are optional. Ex. 2299, 13:29-31 (“the tubular member 140
`
`may include staples or barbs or other such attachment structure for securely locat-
`
`ing the valve 100 within the annulus 206”) (emphasis added).
`
`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
`
`Mot. 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, necessarily reduces
`
`
`
`13
`
`
`
`
`
`perivalvular leaks and necessarily requires some degree of pliability. See Ex. 1028,
`
`Appendix-5 to Appendix-7; see also Ex. 1008 at 9 and Fig. 4; Ex. 2327, 2:46 – 3:3.
`
`Regarding the issue of “pliability,” Norred has not demonstrated that it
`
`would have been nonobvious 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.” Norred Decl., ¶72. (2) Norred’s “solution” was to use a “plia-
`
`ble, 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
`
`conform to the shape of the vessel to create a tight fit that avoids perivalvular
`
`leaks. See Ex. 2304, 4:8-18 (“ring [28] is sufficiently pliable as to conform to ir-
`
`regular openings but will assure a snug fit and seal with the wall of the annulus to
`
`which it is secured.”); Ex. 1021, 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 an-
`
`nulus at the implanting site.”). Norred discounts as irrelevant prior art regarding
`
`pliable rings to anchor a stent that are inserted surgically (Norred Tr., 73:18-74:4),
`
`yet 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
`
`
`
`14
`
`
`
`
`
`about the vessel wall). See In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
`
`Norred asserts that Schreck is deployed at the location of the native aortic
`
`valve and does not extend into the ascending aorta. Mot. at 9-10; Norred Decl.,
`
`¶¶77, 80. That is irrelevant because 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. 1008, Fig.
`
`4. Figulla teaches that deploying the self-expanding stent including a ring member
`
`in the ascending aorta achieves a constant, tight fit of the heart-valve stent configu-
`
`ration. See Ex. 1028, Appendix A-2 at 5-7; Ex. 1008 at 9 and Fig. 4. Norred has
`
`not and cannot meet his burden to show that it would not have been obvious to de-
`
`ploy the Schreck stent in the ascending aorta as taught in Figulla.
`
`Norred has not demonstrated that substitute claims 25 and 26 are 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 Motion to
`
`Amend be denied and that the Board reject proposed substitute claims 25 and 26.
`
`Respectfully submitted,
`
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/s/ Jack S. Barufka
`Jack S. Barufka, Reg. No. 37,087
`Tel. No. 703.770.7712; Fax No. 703.905.2500
`
`15
`
`
`
`Date: November 24, 2014
`
`
`
`
`
`
`
`
`
`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 No-
`
`vember, 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,
`
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`/s/ Jack S. Barufka
`Jack S. Barufka
`Reg. No. 37,087
`Tel. No. 703.770.7712
`Fax No. 703.905.2500
`
`
`
`
`Date: November 24, 2014
`
`
`
`
`
`
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