Trials@uspto.gov
`Tel: 571-272-7822
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` Paper 10
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` Entered: April 25, 2014
`
`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 IPR2014-00111
`Patent 6,482,228 B1
`_______________
`
`
`Before JOSIAH C. COCKS, SHERIDAN K. SNEDDEN, and
`BARRY L. GROSSMAN, Administrative Patent Judges.
`
`GROSSMAN, Administrative Patent Judge.
`
`
`
`DECISION
` Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`
`I. INTRODUCTION
`
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve, LLC
`
`(collectively, ―Petitioner‖) filed a Corrected Petition requesting an inter partes
`
`review of claims 20-24 of U.S. Patent No. 6,482,228 B1 (―the ‘228 patent‖). Paper
`
`4 (―Corrected Pet.‖). Patent Owner, Troy R. Norred, M.D. (―Patent Owner‖), filed
`
`a Patent Owner Preliminary Response. Paper 9 (―Prelim. Resp.‖).
`
`The standard for instituting an inter partes review is set forth in 35 U.S.C.
`
`§ 314(a):
`
`THRESHOLD – The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311 and any
`response filed under section 313 shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of
`the claims challenged in the petition.
`
`Upon consideration of the Petition, Preliminary Response, and the submitted
`
`exhibits, we determine that the information presented in the petition establishes
`
`that there is a reasonable likelihood that Petitioner would prevail in establishing the
`
`unpatentability of claims 20-24.
`
`A. Related Proceedings
`
`Petitioner states that the ‘228 patent is the subject of litigation brought by the
`
`Patent Owner against Petitioner in the U.S. District Court for the District of Kansas
`
`in Troy R. Norred. M.D. v. Medtronic, Inc.,, No. 2:13-cv-02061 (D. Kan. Feb. 6,
`
`2013).
`
`Claims 16-19 of the ‘228 patent are the subject of pending IPR2014-00110.
`
`B. The ’228 Patent
`
`The invention in the challenged claims of the ‘228 patent relates generally to
`
`a percutaneous aortic heart valve made of a tissue material that is placed by a
`
`
`
`2
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`catheter or other means and held in place with a stent system without the need for
`
`surgery. Ex. 1001, col. 1, ll. 7-9, col. 8, ll. 30-31.
`
`C. Illustrative Claim
`
`Claim 20 of the ‘228 patent is the only independent claim challenged in the
`
`Corrected Petition. Challenged claims 21-24 depend directly or indirectly on
`
`independent claim 20. Claim 20, shown below, is illustrative of the claimed
`
`invention:
`
`20. An aortic valve for controlling a blood flow through an
`
`aortic channel upon placement therein, said valve comprising:
`
`a tissue valve having an interior member made of a tissue
`material and presenting an opening movable between open and
`closed positions;
`
`a ring member surrounding said tissue valve, said ring
`member having an outer circumference adapted to seat said ring
`member about an aortic wall surrounding an aortic channel;
` means for maintaining said ring member in said seated
`position about the aortic wall,
`
`said tissue valve interior member responsive to changes of
`conditions within the aorta for movement of said opening
`between a first closed position and a second open position.
`
`D. References Relied Upon
`
`Petitioner relies upon the following prior art references:
`
`Reference
`
`Asserted Date
`
`Pat. Number
`or Other Identifier
`
`Exhibit Number
`
`Spiegel Online
`Article
`
`Figulla
`
`
`
`
`
`―A Foldable,
`Artificial Heart
`Valve‖
`Published German
`Pat. Appl. 195-46-
`692.6
`
`
`Mar. 3, 2000
`
`Jun. 19, 1995
`
`Ex. 1003/1004
`(translation)
`
`Ex. 1005/1006
`(translation)
`
`3
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`Fraunhofer
`
`Schreck
`Garrison
`Ersek
`Shu
`
`Published German
`Pat. Appl. 198-57-
`887 A1
`US 6,454,799
`US 6,425,916
`US 3,657,744
`US 6,139,575
`
`Jul. 6, 2000
`
`Ex. 1007/1008
`(translation)
`
`Apr. 6, 2000
`Feb. 10, 1999
`Apr. 25, 1972
`Apr. 2, 1999
`
`Ex. 1009
`Ex. 1010
`Ex. 1011
`Ex. 1012
`
`E. The Asserted Grounds
`
`Petitioner asserts the following twelve grounds of unpatentability:
`
`Ground
`
`Claims
`Challenged
`
`Statutory Basis
`
`References
`
`20-24
`
`20-24
`
`20-24
`
`20-24
`
`20-24
`
`20-24
`
`20-23
`
`20-23
`
`20-23
`
`22-23
`
`20-23
`
`20-23
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`Corrected Pet. 7.
`
`
`
`§ 102(a)
`
`§ 102(b)
`
`§ 102(a)
`
`§ 102(e)
`
`§ 102(e)
`
`Spiegel Online
`Article
`Figulla
`
`Fraunhofer
`
`Schreck
`
`Garrison
`
`§ 102(b)
`
`Ersek
`
`Spiegel Online
`Article and Shu
`Figulla and Shu
`
`Fraunhofer and
`Shu
`Schreck and Shu
`
`Garrison and Shu
`
`Ersek and Shu
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`§ 103
`
`4
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`
`II. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, ―[a] claim in an unexpired patent shall be given its
`
`broadest reasonable construction in light of the specification of the patent in which
`
`it appears.‖ 37 C.F.R. § 42.100(b); see also Office Patent Trial Practice Guide, 77
`
`Fed. Reg. 48,756, 48764, 48,766 (Aug. 14, 2012) (Claim Construction); In re Am.
`
`Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Any special
`
`definition for a claim term must be set forth in the specification with reasonable
`
`clarity, deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`
`1994). ―[W]hen interpreting a claim, words of the claim are generally given their
`
`ordinary and accustomed meaning, unless it appears from the specification or the
`
`file history that they were used differently by the inventor.‖ Id. Against this
`
`background of general principles, we construe relevant terms in the ‘228 patent.
`
`Petitioner proposes specific constructions for the claim terms ―tissue‖ and
`
`―means for maintaining.‖ Corrected Pet. 8. Patent Owner proposes specific
`
`constructions for these same two claim terms. Prelim. Resp. 16. Patent Owner
`
`also proposes a specific construction for the claim term ―ring member.‖ Id. at 15.
`
`1. ―Tissue‖
`
`Petitioner proposes that the claim term ―tissue‖ is a ―biological tissue, such
`
`as cadaver and porcine tissue.‖ Corrected Pet. 8. Patent Owner proposes the
`
`identical construction. Prelim. Resp. 16.
`
`The written description in the ‘228 patent uses the word ―tissue‖ only once.
`
`Ex. 1001, col. 5, l. 64. This sole use is in the context of describing various valve
`
`designs and states that ―designs that may prove valuable‖ to the ―technique‖
`
`disclosed in the written description include the use of ―biological tissue
`
`incorporated valves, such as cadaver/porcine valves placed within a percutaneously
`
`
`
`5
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`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`stented system.‖ Id. at col. 5, ll. 63-66. The Specification refers to Figures 18 and
`
`19, which illustrate ―a cadaver/porcine incorporated valve and stent system.‖ Id. at
`
`col. 5, l. 67; col. 2, ll. 48-51.
`
`The claims recite only the term ―tissue.‖ The claims do not specify the type
`
`of tissue or the source of the tissue, e.g., ―cadaver‖ or ―porcine‖ tissue. ―While . . .
`
`claims are to be interpreted in light of the specification and with a view to
`
`ascertaining the invention, it does not follow that limitations from the specification
`
`may be read into the claims.‖ Comark Communications, Inc. v. Harris Corp., 156
`
`F.3d 1182, 1186 (Fed. Cir. 1998) (citation omitted), see also Texas Instruments,
`
`Inc. v. United States Int'l Trade Comm'n, 805 F.2d 1558, 1563 (Fed.Cir.1986)
`
`(―This court has cautioned against limiting the claimed invention to preferred
`
`embodiments or specific examples in the specification.‖). Accordingly, the
`
`broadest reasonable construction in light of the Specification of the claim term
`
`―tissue‖ is generally ―biological tissue.‖
`
`2. “Means for Maintaining”
`
`Petitioner asserts the phrase ―means for maintaining said ring member in
`
`said seated position about the aortic wall,‖ as used in claim 20, is to be construed
`
`as a ―means plus function‖ limitation under 35 U.S.C. § 112, ¶ 6. Pet. 8.
`
`Petitioner also asserts that the ‘228 patent describes the structure for performing
`
`the claimed function as ―connecting rods 104,‖ which anchor valve 100 along the
`
`root of the aortic valve. Id. (citing Ex. 1001, col. 6, ll. 4-5). Petitioner thus
`
`concludes that the ―means‖ for performing the claimed function are ―connecting
`
`rods‖ or an equivalent structure. Pet. 8.
`
`Patent Owner has a different view. Patent Owner asserts that the ―means for
`
`maintaining‖ is the stent system 28 or an equivalent structure. Prelim. Resp. 16
`
`(citing Ex. 1001, Abstract; col. 1, ll. 29-31, 59-67; col. 5, ll. 22-25, 48-51).
`
`
`
`6
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`
`It is well established that the use of the term ―means‖ triggers a rebuttable
`
`presumption that § 112, ¶ 6 governs the construction of the claim term. Inventio
`
`AG v. ThyssenKrupp Elevator Ams. Corp., 649 F.3d 1350, 1356 (Fed.Cir.2011)
`
`(citing TriMed, Inc. v. Stryker Corp., 514 F.3d 1256, 1259 (Fed.Cir.2008)). Here,
`
`it is clear, and there is no dispute among the parties, that the claim phrase is a
`
`―means plus function‖ phrase that is interpreted under § 112, ¶ 6.
`
`―The plain and unambiguous meaning of paragraph six is that one construing
`
`means-plus-function language in a claim must look to the specification and
`
`interpret that language in light of the corresponding structure, material, or acts
`
`described therein, and equivalents thereof, to the extent that the specification
`
`provides such disclosure.‖ In re Donaldson Co., Inc., 16 F.3d 1189, 1193 (Fed.
`
`Cir. 1994) (en banc). This is the ―broadest reasonable interpretation‖ of ―means-
`
`plus-function‖ language. Id. at 1194-95. The structure disclosed in the written
`
`description of the specification is the corresponding structure only if the written
`
`description of the specification or the prosecution history clearly links or associates
`
`that structure to the function recited in a means-plus-function claim limitation.
`
`B. Braun Medical Inc., v. Abbott Laboratories, 124 F.3d 1419, 1424 (Fed. Cir.
`
`1997). Claim interpretation under § 112, ¶ 6 does not ―permit incorporation of
`
`structure from the written description beyond that necessary to perform the claimed
`
`function.‖ Micro Chem., Inc. v. Great Plains Chem. Co., 194 F.3d 1250, 1258
`
`(Fed. Cir. 1999).
`
`The function recited in the means-plus-function claim limitation in claim 20
`
`is ―maintaining said ring member in said seated position about the aortic wall.‖
`
`Ex. 1001, col. 8, ll. 36-37. Thus, the initial focus is on the ―ring member‖ and a
`
`determination of the structure that maintains the ring member in a seated position.
`
`
`
`7
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`
`The ‘228 patent discloses four valve designs: figures 6-9 disclose an
`
`umbrella aortic valve; figures 10-13 disclose a cone-shaped aortic valve; figures
`
`14-17 disclose another version of a cone-shaped valve; and figures 18-19 disclose
`
`a cadaver/porcine valve. Ex. 1001, col. 2, ll. 24-51. The term ―ring‖ is used in the
`
`context of the two cone-shaped valves and the cadaver/porcine valve: ―ring 72‖ is
`
`referred to in the valve shown in Figures 10-13; ―ring 86‖ is referred to in the
`
`context of Figures 14-17; and ―ring 102‖ is referred to in the context of Figures 18-
`
`19.
`
`Ring 102 is in the context of a tissue valve specifically recited in claim 20.
`
`Ex. 1001, col. 6, ll. 1-4. Ring 102 is described as ―made of a pliable biocompatible
`
`material which seals against the root of the native aortic valve 34.‖ Ex. 1001, col.
`
`6, ll. 1-9 (emphasis added). We have not been directed to any disclosure that
`
`describes how ring 102 seals against the root of the native aortic valve. We also
`
`have not been directed to any disclosure of how ring 102 is maintained in ―seated
`
`position about the aortic wall,‖ as called for in independent claim 20, or what
`
`structure maintains the ring in this claimed position.
`
`Two types of ―rods‖ are disclosed: rods that are part of the stent; and rods
`
`that are part of the valve. The 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, col. 2, ll. 61-63. There also are rods
`
`that are part of the valve. In the context of the embodiment disclosed in Figures 18
`
`and 19, the Specification states that valve 100 (not ring 102) is anchored with rods
`
`104 connected to stents 28. Id. at col. 6, ll. 4-6; see also id. at col. 4, ll. 6-9 (valve
`
`30 is anchored with rod 56 connected to stent struts 58); id. at col. 5, ll. 21-23
`
`(valve 66 is anchored with rods 80); id. at col. 5, ll. 47-50 (valve 82 is anchored
`
`with connecting rods, not shown). The Specification also states, generally, that the
`
`
`
`8
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`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`valve is anchored ―by a stent system,‖ and the rods merely connect the valve to the
`
`stent. Ex. 1001, col. 1, ll. 30-31 and 63-64
`
`Thus, based on the Specification, in the context of the tissue valve disclosed
`
`in Figures 18 and 19, it is the combination of rods 104 interacting with stent 28 that
`
`anchor valve 100 and seat ring member 102. In that regard, it is rods 104
`
`interacting with stent 28 that are the structure corresponding to the ―means for
`
`maintaining‖ called for in claim 20. This corresponding structure, and equivalents
`
`thereof, is the broadest reasonable construction of the ―means for maintaining‖ the
`
`ring member in seated position at this stage of the proceeding, and we therefore
`
`adopt it for purposes of this Decision.
`
`We also give ordinary meaning to the functional phrase of maintaining the
`
`ring in a ―seated position about the aortic wall,‖ recited in claim 20. The
`
`Specification distinguishes between seating and sealing. See, e.g., Ex. 1001, col.
`
`5, ll. 16-20 (―Base 70 is seated against the root of the aortic valve . . . The rim 78
`
`of base 70 seals against the root of the native aortic valve‖). For purposes of this
`
`Decision, this phrase means that the ring is positioned against the aortic wall. We
`
`decline to require the ring to seal with the aortic wall because the evidence of
`
`record does not support such a special meaning.
`
`3. Ring Member
`
`Patent Owner proposes that the phrase ―ring member,‖ as used in the
`
`challenged claims, means ―a ring made of a pliable, biocompatible material which
`
`seals against the aorta to reduce peri-valvular leaks.‖ Prelim. Resp. 15. Patent
`
`Owner cites the Specification for support for this proposed claim construction. Id.
`
`Petitioner does not propose a specific construction for the phrase ―ring member.‖
`
`We do not to limit the claim phrase ―ring member‖ to a specific material, as
`
`proposed by Patent Owner. Claims 20-24 do not state the material from which the
`
`
`
`9
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`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`ring member is made, and there is no argument or evidence asserted by Patent
`
`Owner that persuades us to read limitations concerning the material from which the
`
`ring member is made from the Specification into the claims. Comark
`
`Communications, 156 F.3d at 1186; Texas Instruments, 805 F.2d at 1563. Patent
`
`Owner offers no persuasive evidence that the ordinary and customary meaning of
`
`the term ―ring member‖ is limited to a pliable, biocompatible material.
`
`We also do not limit the claim phrase ―ring member‖ to include the
`
`functional limitation that the ring member ―seals against the aorta to reduce peri-
`
`valvular leaks.‖ Claims 20-23 state that the outer circumference of the ring
`
`member is ―adapted to seat about an aortic wall surrounding an aortic channel‖
`
`(emphasis added).‖ The challenged claims 20-23 do not state that the ring seals
`
`against anything. Dependent claim 24 adds the limitation that the ring member
`
`seals against the aortic channel wall. As a dependent claim, claim 24 must further
`
`limit claim 20 from which it depends. Thus, seating the ring member about an
`
`aortic wall surrounding an aortic channel, as recited in claim 20, cannot define the
`
`same structure or relationship as sealing the ring member against the aortic channel
`
`wall, as recited in claim 24. The Specification also distinguishes between seating
`
`and sealing. E.g., Ex. 1001, col. 5, ll. 17-21 (―Base 70 is seated . . . rim 78 . . .
`
`seals against the root of the native aortic valve 34. . .‖). The claims do not state the
`
`purpose of the claimed seated arrangement. Patent Owner has not provided any
`
`persuasive argument or evidence that we should ignore the language of the claims
`
`as written and interpret the claim as proposed by Patent Owner. Chef America,
`
`Inc. v. Lamb-Weston, Inc., 358 F. 3d 1371, 1374 (Fed. Cir. 2004) (―Thus, in accord
`
`with our settled practice we construe the claim as written, not as the patentees wish
`
`they had written it.‖).
`
`
`
`10
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`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`
`For purposes of this Decision, the phrase ―ring member‖ does not require a
`
`particular sealing function.
`
`B. Asserted Grounds of Unpatentability
`
`1. Anticipation of Claims 20-24 by Schreck
`
`As one of twelve grounds asserted in the Corrected Petition, Petitioner
`
`asserts that ―each element recited in claims 20-24 is anticipated by Schreck.‖
`
`Corrected Pet. 15. ―A claim is anticipated only if each and every element as set
`
`forth in the claim is found, either expressly or inherently described, in a single
`
`prior art reference.‖ Verdegaal Bros. v. Union Oil Co., 814 F.2d 628, 631 (Fed.
`
`Cir. 1987). ―The identical invention must be shown in as complete detail as is
`
`contained in the . . . claim.‖ Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236
`
`(Fed. Cir. 1989). The elements must be arranged as required by the claim, but this
`
`is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re
`
`Bond, 910 F.2d 831, 832 (Fed. Cir. 1990). ―[U]nless a reference discloses within
`
`the four corners of the document not only all of the limitations claimed but also all
`
`of the limitations arranged or combined in the same way as recited in the claim, it
`
`cannot be said to prove prior invention of the thing claimed and, thus, cannot
`
`anticipate under 35 U.S.C. § 102.‖ Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d
`
`1359, 1371 (Fed. Cir. 2008).
`
`Patent Owner asserts that ―Schreck does not constitute prior art and cannot
`
`serve as a basis to invalidate the ‘228 Patent pursuant to 35 U.S.C. § 102(e).‖
`
`Prelim. Resp. 24. The basis for this assertion is that ―Schreck was filed on April 6,
`
`2000, approximately 16 months after Norred invented the aortic valve described in
`
`the ‘228 Patent.‖ Id.
`
`The effective filing date of Schreck is April 6, 2000. Ex. 1009, 1. The filing
`
`date of the ‘228 patent is November 14, 2000. Thus, Schreck is prior art under the
`
`
`
`11
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`Case IPR2014-00111
`Patent 6,482,228 B1
`
`applicable provision of 35 U.S.C. § 102(e) unless Patent Owner establishes that the
`
`inventions in the challenged claims were invented before April 6, 2000.
`
`Patent Owner cites Exhibit 2103 in support of the asserted date of invention
`
`16 months prior to Schreck‘s filing date. Prelim. Resp. 24. Exhibit 2103 is a
`
`sketch dated ―12/21/98.‖ The sketch is notarized as being signed by ―Troy
`
`Norred‖ on December 21, 1998. The sketch shows an ―aortic valve‖ positioned in
`
`the aorta. Patent Owner states that Exhibit 2103 ―clearly depicts a percutaneous
`
`aortic heart valve held in place with a stent system,‖ and ―bears a striking
`
`similarity to Figure 4 of the ‘228 patent.‖ Id. at 9.
`
`Exhibit 2103 does not address the limitations of claims 20-24 and does not
`
`establish possession of every feature recited in these claims. For example, there is
`
`no evidence that the sketch illustrates a ―tissue valve,‖ or that the sketch illustrates
`
`rods interacting with a stent that form the structure comprising the ―means for
`
`maintaining‖ called for in claim 20. As such, the evidence on which Patent Owner
`
`relies does not establish that the invention in claims 20-24 was invented prior to
`
`April 6, 2000. Thus, for purposes of this Decision, based on the evidence and
`
`arguments asserted by Patent Owner, Schreck is prior art under 35 U.S.C. § 102(e).
`
`a. Claim 20
`
`Schreck discloses expandable heart valves for minimally invasive valve
`
`replacement surgeries. Ex. 1009, Abstract. The Schreck valve is particularly
`
`useful in replacing the aortic valve. Id. at col. 5, ll. 39-42. Petitioner focuses on
`
`the disclosure shown and described for Figure 6 in Schreck. Corrected Pet. 15.
`
`The embodiment in Figure 6 of Schreck is a two-part heart valve having
`
`leaflet subassembly 102 adapted to connect to tissue-engaging base 104. Ex.1009,
`
`col. 8, ll. 63-65. These two components, subassembly 102 and base 104, provide a
`
`tissue-engagement ring. Id. at col. 9, ll. 5-6. Leaflet subassembly 102 includes
`
`
`
`12
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`Case IPR2014-00111
`Patent 6,482,228 B1
`
`wireform 106 supporting a plurality of prosthetic leaflets 108 and fabric skirt 110.
`
`Id. at col. 9, ll. 11-13. In a preferred embodiment, each leaflet 108 is formed from
`
`pericardial tissue, such as bovine or equine pericardium, or a synthetic material
`
`that has been suitably treated to render it biocompatible. Id. at col. 9, ll. 46-50.
`
`Thus, interior elements 108 may be made from a tissue material, as required by
`
`claim 20.
`
`i. Ring Member
`
`Petitioner asserts that the entire leaflet subassembly 102 is the ―ring
`
`member‖ as recited in claims 20-24. Corrected Pet., App. A-4, p. App. 13.
`
`Petitioner does not distinguish among the three components forming subassembly
`
`102, i.e., wireform 106, leaflets 108, and skirt 110. Ex. 1009, col. 9, ll. 11-13.
`
`Petitioner then asserts that ―leaflets 108 are surrounded by leaflet subassembly 102
`
`(‗ring member‘).‖ Id. at App. A-4, p. App. 14. Since leaflets 108 are part of
`
`subassembly 102, leaflets 108 cannot surround themselves. More precisely,
`
`wireform 106, skirt 110 of subassembly 102, and base 104 surround leaflets 108.
`
`Thus, consistent with Schreck‘s disclosure, wireform 106 and skirt 110 of
`
`subassembly 102, and base 104, provide a tissue-engagement ring. Id. at col. 9, ll.
`
`5-6.
`
`Petitioner asserts that Schreck discloses that the outer circumference of the
`
`ring member is adapted to seat about an aortic wall surrounding an aortic channel,
`
`as recited in claim 20 because ―during implantation, fabric skirt 110 is ‗captured
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`between the tubular member 140 and the surrounding tissue, and is in direct
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`contact therewith.‘‖ Corrected Pet. App. A-4, p. App. 14 (citing Ex. 1009, col. 13,
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`ll. 20-26). Tubular member 140 is part of tissue-engaging base 104. Ex. 1009, col.
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`13, ll. 5-6. Thus, Petitioner‘s position is that skirt 110 is the outer circumference of
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`Schreck‘s ring member because it is skirt 110 that seats against the aortic wall.
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`Based on the present record, this interpretation of Schreck appears to be correct.
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`Patent Owner asserts that posts 146 and cusp posts 148 prevent the leaflet
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`subassembly from seating about the aortic channel. Prelim Resp. 25 (citing Ex.
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`1009, Figures 6, 7, 10, 13, and 15). Based on our review of these figures and the
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`Schreck disclosure, the evidence does not appear to support Patent Owner‘s
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`assertion. Figure 10 of Schreck, cited by Patent Owner, appears to illustrate skirt
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`110 on the exterior of post 146. This is consistent with Figure 6. It also is
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`consistent with Schreck‘s disclosure, which states fabric skirt 110 is captured
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`between tubular member 140 and the surrounding tissue, and is in direct contact
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`therewith. Ex. 1009, col. 13, ll. 20-22. Direct contact with the surrounding tissue
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`establishes that the outer circumference of Schreck‘s ring member is adapted to
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`seat against the aortic wall. Also, Schreck discloses that while posts 146, 148 are
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`desirably located on the outside of tubular member 140, the ―reverse
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`configuration‖ also may be used. Ex. 1009, col.10, ll. 18-27. Thus, this appears to
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`allow posts 146 and 148 to be positioned so that fabric skirt 110 is in direct contact
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`with the surrounding tissue, consistent with the Schreck disclosure.
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`ii. Means for Maintaining
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`We have construed the ―means for maintaining‖ clause to be the
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`combination of rods 104 interacting with stent 28 that anchor valve 100 and seat
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`ring member 102, and equivalents thereof. Neither Petitioner nor Patent Owner
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`asserted this construction, as discussed above in Section II-A of this Decision.
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`Schreck discloses ―an expandable stent system adapted to be delivered in a
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`collapsed state to an implantation site and expanded, and a plurality of prosthetic
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`leaflets attached to the stent system.‖ Ex. 1009, col. 2, ll.17-20. In the context of
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`valve 100, tubular member 140 forms a support stent to which the leaflet
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`subassembly is attached. A plurality of posts 146, 148 are attached to the tubular
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`member 140. Ex. 1009, col. 10, ll. 2-7. Posts 146 couple tubular member 140 to
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`commissures 112 of wireform 106, whereas posts 148 couple tubular member 140
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`to the cusps 114 of wireform 106. Id. at col. 10, ll. 8-11. Thus, posts 146, 148,
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`which connect tubular member 140 to wireform 106, and tubular member 140 are
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`the ―means for maintaining‖ the outer circumference of the ―ring member,‖ i.e.,
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`skirt 110, in its seated position.
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`iii. Responsive to Changes
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`Schreck discloses that valve 100 has an inflow end 120 and an outflow end
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`122. Ex. 1009, col. 9, ll. 36-37. In describing the general operation of the
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`disclosed valves, Schreck discloses that the valve opens and closes depending on
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`blood flow forces. Id. at col. 8, l. 2. Schreck states that when the pressure
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`differential is such that blood flows into the inflow end of the valve, the leaflets
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`spread apart and the valve opens. Id. at col. 8, ll. 5-7. When the pressure
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`differential reverses, the leaflets come together, or ―coapt,‖ to close the valve. Id.
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`Thus, the Schreck valve is responsive to changes of conditions, as required by
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`claim 20.
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`Based on the analysis herein, each element set forth in claim 20 is found,
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`either expressly or inherently described, in Schreck, in as complete detail as is
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`contained in claim 20, with the elements arranged as required by the claim.
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`Accordingly, we are persuaded that, on the record before us, Petitioner has
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`demonstrated a reasonable likelihood of prevailing on the ground that claim 20 is
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`anticipated by Schreck.
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`b. Claim 21
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`Claim 21 depends from claim 20 and requires the tissue valve interior
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`member to be responsive to changes in blood pressure to open and close the valve.
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`As described above, the Schreck valve opens and closes in response to blood
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`pressure. Id. at col. 8, ll. 1-9; see Ex. 1020 ¶¶ 22, 23, 25-27. Accordingly, we are
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`persuaded that, on the record before us, Petitioner has demonstrated a reasonable
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`likelihood of prevailing on the ground that claim 21 is anticipated by Schreck.
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`c. Claim 22
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`Claim 22 depends from claim 21 and requires the tissue valve interior
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`member to move to its open position in response to systolic ejection of blood from
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`the left ventricle in which the blood pressure is greater than the blood pressure in
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`the aortic channel. Based on the Declaration of Dr. Vassiliades, this is how the
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`Schreck valve, and other prosthetic valves cited in the Petition, operate. Ex. 1020
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`¶¶ 24, 26. Accordingly, we are persuaded that, on the record before us, Petitioner
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`has demonstrated a reasonable likelihood of prevailing on the ground that claim 22
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`is anticipated by Schreck.
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`d. Claim 23
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`Claim 23 depends from claim 21 and requires the tissue valve interior
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`member to move to the closed position in response to diastolic filling of the left
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`ventricle when the blood pressure in the aortic channel is greater than the blood
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`pressure in the left ventricle. Based on the Declaration of Dr. Vassiliades, this is
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`exactly how the Schreck valve, and other prosthetic valves cited in the Petition,
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`operate. Ex. 1020 ¶¶ 24, 26. Accordingly, we are persuaded that, on the record
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`before us, Petitioner has demonstrated a reasonable likelihood of prevailing on the
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`ground that claim 23 is anticipated by Schreck.
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`e. Claim 24
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`Claim 24 depends from claim 20 and requires the ―ring member‖ to contact
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`the wall of the aortic channel and seal against the aortic channel wall. Petitioner
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`asserts that the ring member in Schreck forms the required seal because fabric skirt
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`110 is in direct contact with surrounding tissue. Corrected Pet., App. A-4, p. App.
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`16-17 (citing Ex. 1009, col. 13, ll. 20-26). The cited passage states that the fabric
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`skirt forms a flow channel for blood entering inflow end 120 of valve 100.
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`Schreck discloses that once in position within the annulus of the valve being
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`replaced, a balloon (or other expanding means) causes the tubular base and fabric
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`to expand into contact with the annulus and are compressed against the host
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`annulus. Ex. 1009, col. 8, ll. 49-61; see col. 12, ll. 7-14. We understand this
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`disclosure to mean that a sealed relationship is established between the ring
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`member and the aortic channel wall, as claimed in claim 24. Accordingly, we are
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`persuaded that, on the record before us, Petitioner has demonstrated a reasonable
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`likelihood of prevailing on the ground that claim 24 is anticipated by Schreck.
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`2. Obviousness of Claims 22 and 23 over Schreck and Shu
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`Petitioner asserts that Shu discloses how a native heart valve works, and the
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`fact that a prosthetic heart valve is designed to mimic the operation of the native
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`heart valve. Corrected Pet. 23. As discussed above, based on the Schreck
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`disclosure and the Declaration of Dr. Vassiliades, we have determined, for
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`purposes of this Decision, that the Schreck valve functions in the same manner as
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`the natural heart valve it replaces. See Ex. 1020 ¶¶ 19, 23-27; Ex. 1009, col. 8, ll.
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`1-9. We recognize, however, that the tests for anticipation and obviousness are
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`different. Cohesive Technologies, Inc. v. Waters Corp., 543 F. 3d 1351, 1364
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`(Fed. Cir. 2008); see, e.g., Duro-Last, Inc. v. Custom Seal, Inc., 321 F.3d 1098,
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`1107-08 (Fed.Cir.2003) (―Succinctly put, the various . . . defenses that may be
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`raised by a defendant—. . . , the several forms of anticipation and loss of right
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`under § 102, and obviousness under § 103—require different elements of proof.‖).
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`Shu discloses that during each cardiac cycle, the natural heart valves
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`alternatively open to allow blood to flow through them and then close to block
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`blood flow. Ex. 1012, col. 1, ll. 11-13. During systole, the aortic and pulmonary
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`valves open to allow blood flow into the aorta and pulmonary arteries. Id. at col. 1,
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`ll. 13-17. Conversely, during diastole, the aortic and pulmonary valves close to
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`prevent reverse blood flow from the aorta and pulmonary arteries into the
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`ventricles. Id. at col. 1, ll. 17-20. The cardiac valves open and close passively in
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`response to blood pressure changes operating against the valve leaflet structure.
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`Id. at col. 1, ll. 21-23.
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`Petitioner asserts that a person of ordinary skill in the art would understand
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`Schreck in view of Shu to teach a prosthetic tissue valve as one that opens during
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`systole, as recited in Claim 22, and closes during diastole, as recited in Claim 23.
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`Corrected Pet. 23-24.
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`Patent Owner asserts that Shu fails to disclose a valve that can be placed
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`non-surgically/percutaneously. Prelim. Resp. 30. The challenged claims recite an
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`aortic valve structure, and do not recite the surgical method for inserting the valve.
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`Thus, this asserted deficiency is not persuasive.
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`Patent Owner argues that Shu teaches away from using a ―tricuspid valve.‖
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`Prelim. Resp. 31. The challeng