Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 41
`Entered: June 25, 2015
`
`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 B1
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, BARRY L. GROSSMAN, and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`WEATHERLY, Administrative Patent Judge.
`
`DECISION
`Final Written Decision
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
`
`LLC (collectively, “Medtronic”) filed a Petition (Paper 4, “Pet.”) requesting
`
`
`Tel: 571-272-7822
`
`Paper 41
`Entered: June 25, 2015
`
`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 B1
`
`
`
`
`
`
`
`
`
`Before SHERIDAN K. SNEDDEN, BARRY L. GROSSMAN, and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`WEATHERLY, Administrative Patent Judge.
`
`DECISION
`Final Written Decision
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
`
`LLC (collectively, “Medtronic”) filed a Petition (Paper 4, “Pet.”) requesting
`
`
`
`IPR2014-00395
`Patent 6,482,228 B1
`
`an inter partes review of claims 16 and 19–24 (the “challenged claims”) of
`
`U.S. Patent No. 6,482,228 B1 (Exhibit 1001, “the ’228 patent”). 35 U.S.C.
`
`§ 311. Troy R. Norred, M.D. (“Dr. Norred” or “Patent Owner”) timely filed
`
`a Preliminary Response. Paper 11 (“Prelim. Resp.”). On June 27, 2014, we
`
`instituted an inter partes review of all challenged claims, Paper 13 (“Dec.”
`
`or “Institution Decision”), on the following grounds:
`
`References
`
`Basis
`
`Claims Reviewed
`
`U.S. Patent No. 5,957,949,
`(“Leonhardt”) (Ex. 1004)
`
`U.S. Patent No. 6,458,153 B1,
`(“Bailey”) (Ex. 1006)
`
`Dec. 20.
`
`§ 102(b) 16 and 19–24
`
`§ 102(e) 16 and 19–24
`
`After we instituted review, Dr. Norred filed a Patent Owner Response,
`
`Paper 18 (“PO Resp.”), in opposition to the Petition, and supported by the
`
`declarations of Timothy T. Catchings, M.D. (Ex. 2295) and Troy R. Norred,
`
`M.D. (Ex. 2293). Medtronic filed a Reply in support of the Petition, Paper
`
`22 (“Reply”), supported by the Declaration of Alexander J. Hill, PhD
`
`(Ex. 1026).
`
`Dr. Norred also filed a Motion to Amend, Paper 17 (“Mot. Amend”),
`
`seeking to substitute claim 25 for independent claims 16 and 20 and claim
`
`26 for dependent claim 24 contingent upon our holding unpatentable any of
`
`the original claims for which substituted claims were submitted. Mot.
`
`Amend 1. Medtronic opposed the Motion to Amend. Paper 25 (“Amend
`
`Opp.”). Dr. Norred filed a reply in support of its Motion to Amend. Paper
`
`28 (“Amend Reply”).
`
`2
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`
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`IPR2014-00395
`Patent 6,482,228 B1
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`Oral argument was conducted on January 27, 2015. A transcript is
`
`entered as Paper 40 (“Tr.”).
`
`For the reasons expressed below, we conclude that Medtronic has
`
`demonstrated, by a preponderance of evidence, that each of Leonhardt and
`
`Bailey anticipates claims 16 and 19–24. Dr. Norred’s Motion to Amend is
`
`denied.
`
`B. Related Matters
`
`Medtronic and Dr. Norred identified, as related proceedings, the co-
`
`pending litigation titled Troy R. Norred, M.D. v. Medtronic, Inc., No. 2:13-
`
`CV-02061 (D. Kan.). Pet. 1; Paper 11, 5. Two proceedings before the
`
`Board involving the same parties, IPR2014-00110 and IPR2014-00111, also
`
`are identified as related proceedings. Pet. 1; Paper 11, 5–6.
`
`C. The ’228 Patent
`
`The ’228 patent relates to a percutaneous aortic heart valve that is
`
`placed by catheter and held in place with a stent system. Ex. 1001, 1:6–9,
`
`1:29–31. Figures 10 and 11 of the ’228 patent are reproduced below.
`
`
`
`
`
`Figures 10 and 11 illustrate a diagrammatic and plan view of
`one embodiment of Dr. Norred’s cone-shaped aortic valve in a
`closed position.
`
`Id. at 2:31–34.
`
`3
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`
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`IPR2014-00395
`Patent 6,482,228 B1
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`Valve 66 consists of interconnected fingers 68, generally ring-shaped
`
`base 70, and ring 72 secured to base 70. Id. at 4:54–64. Base 70 may be
`
`seated against the root of the aortic valve. Id. at 5:17–19. Rim 78 of base 70
`
`is made of a pliable biocompatible material and seals against the root of the
`
`native aortic valve to reduce peri-valvular leaks. Id. at 5:18–20. Valve 66 is
`
`anchored along the root of the aortic valve with connecting rods 80, which
`
`are connected to ascending aortic stents 28. Id. at 5:21–23.
`
`The ’228 patent describes additional embodiments of an aortic heart
`
`valve in which the valve structures differ. See, e.g., id. at 4:5–52 (describing
`
`umbrella valve 30 illustrated in Figures 6–9), 5:33–62 (describing trihedral
`
`valve 82 illustrated in Figures 14–17), 5:63–6:8 (describing biological valve
`
`100 illustrated in Figures 18 and 19). Nevertheless, the illustrated
`
`embodiments of the aortic valves are held in place via a mechanical
`
`attachment to a stent that seats against the aortic wall. See id. at 4:8–9,
`
`5:21–23, 5:48–51, 6:3–7 (describing connecting rods that attach valves to
`
`stent).
`
`Claims 16 and 20, which are the only independent claims among the
`
`challenged claims, recite:
`
`16. An aortic valve for regulating a blood flow through
`an aortic channel surrounded by an aortic wall upon placement
`therein, said valve comprising:
`
`a ring member having a circumference adapted to seat
`about an aortic wall surrounding an aortic channel, said ring
`including an aperture for blood flow therethrough;
`
`a membrane having first and second spaced-apart open
`ends, said membrane made of a material resistant to a fluid flow
`therethrough; and
`
`means for mounting said first open end of said membrane
`about said ring aperture with said second open end displaced
`
`4
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`Patent 6,482,228 B1
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`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.
`
`Ex. 1001, 7:59–8:12.
`
`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.
`
`Id. at 8:27–42.
`
`II. ANALYSIS
`
`A. Claim Interpretation
`
`“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); accord In re Cuozzo Speed Techs., LLC, 778 F.3d
`
`1271, 1278–82 (Fed. Cir. 2015). When applying that standard, we interpret
`
`the claim language as it would be understood by one of ordinary skill in the
`
`art in light of the specification. In re Suitco Surface, Inc., 603 F.3d 1255,
`
`1260 (Fed. Cir. 2010). Thus, we give claim terms their ordinary and
`
`customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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`5
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`(Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning that
`
`the term would have to a person of ordinary skill in the art in question.”
`
`(internal quotation marks omitted)). Only terms which are in controversy
`
`need to be construed, and then only to the extent necessary to resolve the
`
`controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803
`
`(Fed. Cir. 1999).
`
`Claim 19 recites a “means for maintaining said ring member in said
`
`seat about the aortic wall.” Similarly, independent claim 20 and, thus, also
`
`its dependent claims 21–24 recite “means for maintaining said ring member
`
`in said seated position about the aortic wall.” In our Institution Decision, we
`
`interpreted the “means for maintaining” recited in claims 19 and 20 under
`
`35 U.S.C. § 112, ¶ 6. Dec. 12. Based on our review of the Specification, we
`
`identified the combination of rods 104 interacting with stent 28 as the
`
`structures for performing the recited “maintaining” function. We, therefore,
`
`interpreted the “means for maintaining” as rods 1041 interacting with stent
`
`28 and equivalent structures. Id. at 12–13.
`
`During the trial, Dr. Norred argued that the “means for maintaining”
`
`refers not only to a stent, but also requires that the stent be configured to
`
`extend into the ascending aorta. PO Resp. 10. Medtronic suggests that a
`
`“more precise construction” is “rods 104 to interact with stent 28.” Reply 8
`
`n.12. For the reasons expressed below, we maintain our previous
`
`interpretation of “means for maintaining” as referring to the combination of
`
`
`1 Other structures identified in the Specification for performing the
`maintaining function are connecting rods 80 interacting with stent 28.
`Ex. 1001, 5:47–50. We refer to connecting rods 104 throughout our analysis
`for convenience.
`
`6
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`IPR2014-00395
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`rods 104 interacting with stent 28 and their equivalent structures and we
`
`reject both parties’ arguments for altering that interpretation.
`
`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. Williamson v. Citrix Online, LLC, No. 2013-1130, 2015 WL 3687459,
`
`at *7 (en banc) (Fed. Cir. June 16, 2015); 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 “means for
`
`maintaining” is a “means plus function” phrase that is interpreted under
`
`§ 112, ¶ 6.
`
`The first step in the construction of a means-plus-function claim
`
`element is to identify the particular claimed function. Micro Chem., Inc. v.
`
`Great Plains Chem. Co., Inc., 194 F.3d 1250, 1258 (Fed. Cir. 1999). The
`
`second step in the analysis is to look to the specification and identify the
`
`corresponding structure for that function. Id. “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-
`
`7
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`IPR2014-00395
`Patent 6,482,228 B1
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`function claim limitation. B. Braun Med. Inc., v. Abbott Labs., 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, 194 F.3d at 1258.
`
`The function recited in the “means for maintaining” of claims 19 and
`
`20 is “maintaining said ring member in said seated position about the aortic
`
`wall.”2 Ex. 1001, 8:37–38 (emphasis added). Thus, the focus is on the “ring
`
`member,” and a determination of the structure that maintains ring member
`
`102 in a seated position about the aortic wall.
`
`Based on Medtronic’s suggested “more precise” construction, the
`
`parties’ constructions for the “means for maintaining” phrase appear to be
`
`similar, but, in fact, are very different. Medtronic asserts that the challenged
`
`claims are limited to an aortic valve. Reply 8 n.2 (“the claims are directed to
`
`the ‘aortic valve’ and not a valve/stent combination”); see also Tr. 16:3–7
`
`(“[t]he claims are all directed to a valve . . . [t]he claims are really directed to
`
`the valve alone”). Thus, Medtronic’s proposed construction, including the
`
`“more precise” suggestion in Medtronic’s Reply (Reply 8 n.2), does not
`
`include the stent as an element of the “means for maintaining.”
`
`Dr. Norred agrees that claim 16 is directed solely to the valve, but
`
`maintains that claims 19–24, which recite the “means for maintaining,” are
`
`
`2 Claim 19 recites substantially the same function using slightly different
`phrasing as follows: “means for maintaining said ring member in said seat
`about the aortic wall.” Ex. 1001, 8:25–26. We do not consider the different
`phrasing to be material to our analysis.
`
`8
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`Patent 6,482,228 B1
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`directed to the combination of a valve and stent. Tr. 37:25–38:4.3
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`Dr. Norred asserts that “the rods cannot maintain the valve in place by itself.
`
`It is the interaction with the stent system” that maintains the ring member in
`
`a seated position about the aortic wall. Tr. 37:2–3. We are persuaded that
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`Dr. Norred’s construction is correct.
`
`The Specification discloses rods that are part of the stent and rods that
`
`connect the valve to the stent system. Stent system 28 comprises a small
`
`slotted stainless steel tube or series of interconnected rods, which form an
`
`expandable cylindrical lattice or scaffolding. Ex. 1001, 2:61–63. In the
`
`context of the embodiment disclosed in Figures 18 and 19, the Specification
`
`states that valve 100 (not ring 102) is anchored along the root of the aortic
`
`valve with rods 104 connected to stents 28. Id. at 6:4–6, see also id. at 4:6–9
`
`(valve 30 is anchored with rod 56 connected to stent struts 58), 5:21–23
`
`(valve 66 is anchored with rods 80), 5:47–50 (valve 82 is anchored with
`
`connecting rods, not shown). The Specification also states, generally, that
`
`the valve is anchored “by a stent system,” and the rods connect the valve to
`
`the stent. Ex. 1001, 1:30–31, 1:63–64. Thus, rods 104 on valve 100 and
`
`stent system 28 are related inextricably in performing the function of
`
`maintaining the valve, and hence the ring member, which is part of the
`
`valve, anchored along the root of the aortic valve.
`
`
`3 Q. “would you agree that Claim 16 is directed solely to the valve?
`MR. KERNELL [counsel for Patent Owner]: Yeah. You know, I think
`that’s fair that that is the valve as it’s maintained or that the valve that’s
`implanted and that Claim 19 [and claims 20–24] adds the means for
`maintaining, which is the stent system, the ascending aortic stent system.”
`
`9
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`IPR2014-00395
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`The function recited in the “means for maintaining” in claims 19 and
`
`20 is maintaining the ring member in a “seated position about the aortic
`
`wall.” Ex. 1001, 8:37–38 (emphasis added). The written description in the
`
`Specification distinguishes between seating and sealing. See, e.g., Ex. 1001,
`
`5:16–20 (“Base 70 is seated against the root of the aortic valve . . . The rim
`
`78 of base 70 is made of a pliable biocompatible material which seals
`
`against the root of the native aortic valve.”) (emphasis added). In the written
`
`description, ring 102 is described as “made of a pliable biocompatible
`
`material which seals against the root of the native aortic valve 34.”
`
`Ex. 1001, 6:1–9 (emphasis added). The Specification describes valve 100 as
`
`“anchored” along the root of the aortic valve. Id. There is no explicit
`
`disclosure about ring 102 seating about the aortic wall.
`
`The claims themselves provide substantial guidance as to the meaning
`
`of particular claim terms. Independent claim 20 states the ring member has
`
`“an outer circumference” adapted “to seat” the ring member about an aortic
`
`wall surrounding an aortic channel. Id. at 8:33–36 (emphasis added). Claim
`
`24, dependent from claim 20, states that the ring member “contacts the wall
`
`of the aortic channel and seals said ring against the aortic channel wall.” Id.
`
`at 8:56–59 (emphasis added).
`
`Dependent claims must further limit the claim from which they
`
`depend. 35 U.S.C. § 112, ¶ 4 (“a claim in dependent form shall contain a
`
`reference to a claim previously set forth and then specify a further limitation
`
`of the subject matter claimed. A claim in dependent form shall be construed
`
`to incorporate by reference all the limitations of the claim to which it
`
`refers.”); Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (“the
`
`presence of a dependent claim that adds a particular limitation gives rise to a
`
`10
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`presumption that the limitation in question is not present in the independent
`
`claim”). Thus, the presumption is that a ring member that seals, as recited in
`
`claim 24, is different from a ring member that seats, as recited in claim 20.
`
`In describing the general relationship of the valve and stent system,
`
`the Specification states that when the valve/stent combination is in position,
`
`an angioplasty balloon inflates to expand the stent scaffolding and force the
`
`stent system against the inner walls of the ascending aorta to anchor the
`
`valve in place. Ex. 1001, 3:7–10. We construe the requirement to “seat” in
`
`the “means for maintaining” clause in claim 20 to mean that the ring is
`
`anchored, or forced, against the aortic wall. We decline to require that
`
`seating and sealing are synonymous because the evidence of record does not
`
`support such a construction.
`
`Thus, based on the Specification, it is the combination of rods 104
`
`interacting with stent system 28 that anchors valve 100 and seats ring
`
`member 102. Without the stent, there is no structure to maintain the ring
`
`member in seated position. Accordingly, it is rods 104 interacting with stent
`
`system 28 that is the structure corresponding to the “means for maintaining”
`
`called for in claims 19 and 20. This corresponding structure, and
`
`equivalents thereof, is the broadest reasonable construction of the “means for
`
`maintaining” the ring member in seated position. We are not persuaded to
`
`modify this construction as suggested by either party.
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`B. The Challenges to the Claims
`
`“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. of Cal., 814 F.2d 628, 631
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`11
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`(Fed. Cir. 1987). With this standard in mind, we address each challenge
`
`below.
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`Our Scheduling Order in this case cautioned Dr. Norred that “any
`
`arguments for patentability not raised in the [Patent Owner Response] will
`
`be deemed waived.” Paper 14, 2–3. The Board’s Trial Practice Guide,
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`furthermore, states that the Patent Owner Response “should identify all the
`
`involved claims that are believed to be patentable and state the basis for that
`
`belief.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
`
`(Aug. 14, 2012) Furthermore, as the Board has stated, our governing statute
`
`and Rules “clearly place some onus on the patent owner, once trial is
`
`instituted, to address the material facts raised by the petition as jeopardizing
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`patentability of the challenged claims.” Johnson Health Tech Co. Ltd. v.
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`Icon Health & Fitness, Inc., Case IPR2013-00463, slip op. at 12 (PTAB Jan.
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`29, 2015) (Paper 41).
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`In our Institution Decision, we concluded that Medtronic had made a
`
`threshold showing that each of Leonhardt and Bailey taught all the
`
`limitations of the challenged claims, sufficient for us to conclude that there
`
`was a reasonable likelihood that Medtronic would prevail in showing that
`
`the challenged claims were anticipated by each of Leonhardt and Bailey.
`
`Dec. 10–12. We must now determine whether the preponderance of the
`
`evidence of record supports a finding that each of Leonhardt and Bailey
`
`anticipates the challenged claims. 35 U.S.C. § 316(e).
`
`In the Patent Owner’s Response, Dr. Norred presents argument and
`
`evidence to establish that both Leonhardt and Bailey fail to disclose the
`
`“ring member” (required by claims 16 and 19–24) and “means for
`
`maintaining” (required by claims 19–24). Dr. Norred does not present
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`12
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`persuasive evidence or argument on the remaining elements of the claims,
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`that is, those elements other than the “ring member” and the “means for
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`maintaining.” Thus, the record now contains the same arguments and
`
`evidence regarding the merits of Leonhardt’s and Bailey’s alleged
`
`anticipation with regard to the remaining elements of the claims as it did at
`
`the time of our Institution Decision. Thus, the preponderance of the
`
`evidence of record developed at trial supports our conclusion that Medtronic
`
`has set forth how these remaining limitations of the challenged claims are
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`taught by Leonhardt and Bailey. Accordingly, we do not address these
`
`remaining limitations in our discussion below.
`
`1. Anticipation of Claims 16 and 19–24 by Leonhardt
`
`Leonhardt generally describes a percutaneously placed artificial valve
`
`“to maintain bodily fluid flow in a single direction” to “be placed anywhere
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`flow control is desired.” Ex. 1004, 1:11–14. The aorta is among those
`
`locations at which Leonhardt contemplates deploying its artificial valve. Id.
`
`at 3:59–60, 9:64–10:21. Leonhardt’s Figures 3 and 4 are reproduced below.
`
`13
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`Figure 3 depicts Leonhardt’s
`valve stent 20 fully deployed
`with the aorta above the aortic
`valve.
`
`Id. at 3:59–62, 6:23–33.
`
`
`
`Leonhardt’s Figure 4 depicts a
`partial sectional view of valve
`stent 20 incorporating porcine
`valve 22.
`
`Medtronic contends that Leonhardt discloses the claimed aortic valve
`
`and provides claim charts that identify in detail how Leonhardt’s description
`
`of its artificial heart valve discloses each element of all challenged claims.
`
`Pet. 15–17, App. A-1. Dr. Norred argues that Medtronic’s showing that
`
`Leonhardt anticipates claims 16 and 19–24 is deficient for two reasons, and
`
`we address each in turn below.
`
`a) Ring Member—Claims 16 and 19–24
`
`(1) Claims 16 and 19–23
`
`Dr. Norred contends that Leonhardt fails to disclose the claimed ring
`
`member because Leonhardt’s stent 26 is not made of a pliable material. PO
`
`Resp. 8–10. Even if we were to accept Dr. Norred’s contention that the
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`14
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`claimed ring member must be made of a pliable material,4 Dr. Norred’s
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`argument is unpersuasive. Leonhardt’s stent 12 is preferably formed of
`
`superelastic nitinol wire. Ex. 1004, 3:48–56, 4:27–29, 4:63–5:2. Dr.
`
`Norred’s expert witness, Dr. Catchings, testified that he considers nitinol to
`
`be a pliable material. Ex. 1023, 195:8–10. Therefore, we find that
`
`Leonhardt describes a ring member that is made of pliable material and
`
`reject Dr. Norred’s argument that Leonhardt fails to teach the ring member
`
`recited in claims 16 and 19–24.
`
`(2) Claim 24
`
`Claim 24 further recites that “said ring member contacts the wall of
`
`the aortic channel and seals said ring against the aortic channel wall to
`
`reduce blood flow therearound.” Ex. 1001, 8:56–59. Dr. Norred contends
`
`that Leonhardt’s stent 26 is merely temporarily sealed to the wall of the aorta
`
`using a light-activated bioadhesive and, therefore, fails to “seal” against the
`
`aortic channel wall. PO Resp. 9. Dr. Norred reasons that the temporary
`
`nature of Leonhardt’s seal is evident because the stent 26 may be
`
`repositioned or removed after it is fully implanted. Id. (citing Ex. 1004, 3:4–
`
`6, 3:27–30, 11:37–53).
`
`We are not persuaded by Dr. Norred’s argument. Dr. Norred
`
`identifies no basis for interpreting claim 24 such that its seal must be
`
`permanent. A temporary seal is a seal within the meaning of “seal” as
`
`
`4 The parties dispute whether the claims recite a “ring member” that must be
`made from pliable material. We need not resolve that dispute here because
`we find that Medtronic has identified a structure in each of Leonhardt and
`Bailey as the claimed ring member and each of those structures is made of a
`pliable material.
`
`15
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`
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`IPR2014-00395
`Patent 6,482,228 B1
`
`recited in claim 24. Even if we were to conclude that claim 24 requires a
`
`permanent seal, we remain unpersuaded by Dr. Norred’s argument. Claim
`
`24 by its plain terms refers to a seal that “reduce[s] blood flow” around the
`
`ring member. Leonhardt meets this limitation as well. For example,
`
`Leonhardt describes that the stent is sized “to be approximately thirty
`
`percent (30%) larger in diameter than the largest diameter of the tissue
`
`against which the valve stent 20 (FIG. 3) will seal.” Ex. 1004, 5:3–5. The
`
`seal that Leonhardt describes is precisely the type of seal recited in claim 24.
`
`Accordingly, we reject Dr. Norred’s argument that Leonhardt fails to
`
`describe the ring member recited in claim 24.
`
`b) Means for Maintaining—Claims 19–24
`
`Dr. Norred argues that Leonhardt fails to describe the “means for
`
`maintaining.” PO Resp. 10–11. Dr. Norred’s argument is premised upon
`
`our acceptance of his proposed limitation on the claimed “means for
`
`maintaining” that would require the claimed means to be positioned in the
`
`ascending aorta. For reasons expressed in part II.A above, we decline to
`
`interpret the “means for maintaining” as being so limited. Even if we were
`
`to accept Dr. Norred’s proposed interpretation, the argument would remain
`
`unpersuasive because Leonhardt’s stent is “fully deployed within the aorta
`
`above the aortic valve.” Reply 2 (citing Ex. 1004, 3:59–60, Fig. 3).
`
`Accordingly, we reject Dr. Norred’s argument that Leonhardt fails to
`
`describe the “means for maintaining” recited in claims 19–24.
`
`2. Anticipation of Claims 16 and 19–24 by Bailey
`
`Bailey generally describes a prosthetic cardiac valve comprising stent
`
`support member 12, graft member 11 covering at least a portion of stent 12,
`
`and biological xenograft valve flaps/leaflets 28. Pet. 20 (citing Ex. 1006,
`
`16
`
`
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`IPR2014-00395
`Patent 6,482,228 B1
`
`1:6–21, 28–38, 5:61–6:9, 7:58–8:19). Bailey’s Figures 1 and 2 are
`
`reproduced below.
`
`
`
`
`
`Bailey’s Figures 1 and 2 illustrate an embodiment of a
`chamber-to-vessel valve stent in its fully deployed state with
`Figure 2 having a portion of the outermost graft layer removed
`to depict the valve apparatus within the stent.
`
`Ex. 1006, 6:44–49. Bailey’s artificial valve is implanted in the location of
`
`the natural aortic valve. Id. at 10:31–44, Figs. 6A, 6B. Bailey’s artificial
`
`valve is held in place by two different anchor sections, proximal anchor
`
`flange 22 and distal anchor portion 16. Id. at 5:61–6:7, 8:40–43.
`
`Medtronic contends that Bailey discloses the claimed aortic valve and
`
`provides claim charts that identify in detail how Bailey’s description of its
`
`artificial heart valve discloses each element of all challenged claims.
`
`Pet. 19–21, App. A-3. Dr. Norred argues that Medtronic’s showing that
`
`Bailey anticipates claims 16 and 19–24 is deficient for three reasons, and we
`
`address each in turn below.
`
`a) Dr. Norred’s Alleged Priority of Invention over Bailey
`
`Dr. Norred asserts that he conceived subject matter of the challenged
`
`claims no later than December 21, 1998, and diligently reduced that subject
`
`17
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`
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`IPR2014-00395
`Patent 6,482,228 B1
`
`matter to practice from that conception date until filing the application that
`
`matured into the ’228 patent on November 14, 2000.5 PO Resp. 12–30.
`
`Dr. Norred bears the burden to establish the facts necessary to overcome
`
`Bailey’s filing date. In re Facius, 408 F.2d 1396, 1403–04 (CCPA 1969)
`
`(holding, in a prosecution context, that an earlier filed reference was prima
`
`facie available as prior art and placing the burden on the party claiming prior
`
`invention to overcome that reference). Dr. Norred may meet his burden by
`
`providing evidence that the effective date of the reference is not “before the
`
`invention by the applicant for patent,” that is, antedating the Bailey
`
`reference. 35 U.S.C. § 102(e) (2000).
`
`The application resulting in the issuance of Bailey was filed on
`
`December 31, 1999, and Bailey issued on October 1, 2002. The application
`
`that matured into the ’228 patent was filed on November 14, 2000. Bailey is
`
`available as prior against the challenged claims under 35 U.S.C. § 102(e)(2)
`
`as of December 31, 1999, unless Dr. Norred establishes that he conceived
`
`the claimed subject matter before December 31, 1999, and diligently worked
`
`to reduce that subject matter to practice until November 14, 2000.6 We
`
`
`5 Dr. Norred states that November 20, 2000, is the filing date of the
`application leading to issuance of the ’228 patent. PO Resp. 21.
`Nevertheless, that application was filed on November 14, 2000. Ex. 1001,
`Cover Page.
`6 The governing statute provides: “A person shall be entitled to a patent
`unless . . .
`
`(e) the invention was described in . . . (2) a patent granted on an
`application for patent by another filed in the United States before the
`invention by the applicant for patent.”
`
`35 U.S.C. § 102(e) (2000).
`
`18
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`
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`IPR2014-00395
`Patent 6,482,228 B1
`
`evaluate Dr. Norred’s arguments and evidence under the general standards
`
`established in 37 C.F.R. § 1.131, which states:
`
`When any claim of an application or a patent under
`reexamination is rejected, the applicant or patent owner may
`submit an appropriate oath or declaration to establish invention
`of the subject matter of the rejected claim prior to the effective
`date of the reference or activity on which the rejection is based.
`
`37 C.F.R. § 1.131(a). The standards by which we evaluate Dr. Norred’s
`
`asserted date of invention are stated in 37 C.F.R. § 1.131(b), which states:
`
`The showing of facts for an oath or declaration under paragraph
`(a) of this section shall be such, in character and weight, as to
`establish reduction to practice prior to the effective date of the
`reference, or conception of the invention prior to the effective
`date of the reference coupled with due diligence from prior to
`said date to a subsequent reduction to practice or to the filing of
`the application.
`
`37 C.F.R. § 1.131(b).
`
`The required conception of the invention is the “formation in the mind
`
`of the inventor, of a definite and permanent idea of the complete and
`
`operative invention, as it is hereafter to be applied in practice.” Dawson v.
`
`Dawson, 710 F. 3d 1347, 1352 (Fed. Cir. 2013); Coleman v. Dines, 754 F.2d
`
`353, 359 (Fed. Cir. 1985) (citing Gunter v. Stream, 573 F.2d 77, 80 (CCPA
`
`1978)). Based on that definition, our reviewing court has held that
`
`“[c]onception is complete only when the idea is so clearly defined in the
`
`inventor’s mind that only ordinary skill would be necessary to reduce the
`
`invention to practice, without extensive research or experimentation,” and
`
`that “[a]n idea is definite and permanent when the inventor has a specific,
`
`settled idea, a particular solution to the problem at hand, not just a general
`
`goal or research plan he hopes to pursue.” Id.
`
`19
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`IPR2014-00395
`Patent 6,482,228 B1
`
`Thus, conception requires more than accidental creation; there must
`
`be evidence that the inventor appreciated that he made “something new.”
`
`Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1063–64 (Fed. Cir.
`
`2005). “The conception analysis necessarily turns on the inventor’s ability
`
`to describe his invention with particularity. Until he can do so, he cannot
`
`prove possession of the complete mental picture of the invention.”
`
`Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir.
`
`1994).
`
`Proof of conception must be by “corroborating evidence which shows
`
`that the inventor disclosed to others his ‘completed thought expressed in
`
`such clear terms as to enable those skilled in the art’ to make the invention.”
`
`Coleman, 754 F.2d at 359 (citing Field v. Knowles, 183 F.2d 593, 601
`
`(CCPA 1950)); see also Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577
`
`(Fed. Cir. 1996) (corroboration requirement “arose out of a concern that
`
`inventors testifying in patent infringement cases would be tempted to
`
`remember facts favorable to their case by the lure of protecting their patent
`
`or defeating another’s patent”). The sufficiency of corroboration is
`
`determined according to a “rule of reas
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