Trials@uspto.gov
`Tel: 571–272-7822
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` Paper 47
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` Entered: April 23, 2015
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`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 SHERIDAN K. SNEDDEN, BARRY L. GROSSMAN and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`GROSSMAN, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`

`

`Case IPR2014-00111
`Patent 6,482,228 B1
`
`
`I. INTRODUCTION
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`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve, LLC
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`(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”).
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`Paper 4 (“Pet.”). On April 25, 2014, we instituted an inter partes review of claims
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`20–24 under 35 U.S.C. § 102 as anticipated by Schreck (Ex. 1009)1, and claims 22
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`and 23 under 35 U.S.C. § 103 for obviousness over Schreck and Shu (Ex. 1012)2.
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`Paper 10 (“Decision”). Troy R. Norred, M.D. (“Patent Owner”), filed a Patent
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`Owner Response. Paper 15 (“PO Resp.”). Petitioner filed a reply. Paper 25 (“Pet.
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`Reply”).
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`Patent Owner filed a Substitute Motion to Amend. Paper 18 (“PO Mot.
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`Amend”). Petitioner filed an Opposition to the Motion to Amend. Paper 26
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`(“Opp. Mot. Amend”). Patent Owner filed a Reply in Support of the Motion to
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`Amend. Paper 31 (“PO Reply”).
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`Neither party filed motions to exclude evidence.
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`An oral hearing was held on January 27, 2015. A transcript of the hearing is
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`included in the record. Paper 45 (“Tr.”).
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`We have jurisdiction under 35 U.S.C. § 6(c). This Final Written Decision is
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`issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`For the reasons that follow, we determine Petitioner has shown, by a
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`preponderance of the evidence, that claims 20–24 are unpatentable.
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`A. Related Proceedings
`
`The ’228 patent is the subject of a district court case brought by the Patent
`
`Owner against Petitioner in the U.S. District Court for the District of Kansas in
`
`
`1 US Patent 6,454,799 B1, filed April 6, 2000, patented September 24, 2002.
`2 US Patent 6,139,575, filed April 2, 1999, patented October 31, 2000.
`2
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`Case IPR2014-00111
`Patent 6,482,228 B1
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`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.
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`Claims 16 and 19–24 of the ’228 patent are the subject of pending IPR2014-
`
`00395.
`
`B. The ’228 Patent
`
`The invention disclosed in the’228 patent relates generally to a percutaneous
`
`aortic heart valve made of a tissue material. Ex. 1001, col. 1, ll. 79, col. 8,
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`ll. 3031. Figure 4 of the ’228 patent is reproduced below.
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`Figure 4 of the ’228 patent illustrates an exemplary placement of
`valve 30 above aortic valve 34 and below coronary arteries 38.
`
`
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`As shown generally in Figure 4 of the ’228 patent, stent system 28 anchors aortic
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`valve replacement, or artificial valve, 30 in ascending aorta 32 (see Figs. 1–3). Id.
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`at col. 1, ll. 30–31, col. 2, ll. 55–60. Valve 30 is placed “percutaneously,” that is,
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`without the need for open-heart surgery. Id. at Abstract, col. 1, ll. 26–27. Valve
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`30 is positioned above native aortic valve 34 and below coronary arteries 38 so that
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`coronary arteries 38 are not unobstructed. Id. at col. 3, ll. 1–6. Stent system 28
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`comprises a series of interconnected rods, which form an expandable cylindrical
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`Case IPR2014-00111
`Patent 6,482,228 B1
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`lattice or scaffolding. Id. at col. 2, ll. 61–63. Using valve 30 and stent system 28
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`avoids the need to remove native aortic valve 34. Id. at col. 3, ll. 31–32.
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`The ’228 patent discloses four different embodiments for generic artificial
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`valve 30: an “umbrella” aortic valve, shown in Figures 6–9; a first “cone-shaped”
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`aortic valve, shown in Figures 10–13; a second “cone-shaped” aortic valve,
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`shown in Figures 14–17; and a “cadaver/porcine,” or “natural” or “tissue,”
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`replacement aortic valve, shown in Figures 18 and 19. E.g., id. at col. 2, ll. 24–51;
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`Tr. 34, ll. 1–5.
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`Challenged claims 20–24 recite that the claimed aortic valve is “a tissue
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`valve having an interior member made of a tissue material.” Ex. 1001, col. 8,
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`ll. 30–31. The only “tissue” valve disclosed in the Specification is in the context of
`
`Figures 18 and 19. The Specification states: “[o]ther valvular designs which may
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`prove valuable to this technique include the usage of biological tissue incorporated
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`valves, such as cadaver/porcine valves, placed within a percutaneously stented
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`system the benefits of favorable flow and hematologic characteristics (see FIGS.
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`18 and 19).” Id. at col. 5, ll. 63–67 (emphasis added), see also, col. 2, ll. 48–51
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`(“FIG. 18 is a diagrammatic view of a cadaver/porcine incorporated valve and stent
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`system”). Claims 20–24, thus, are directed to the embodiment disclosed in Figures
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`18 and 19, reproduced below.
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`Case IPR2014-00111
`Patent 6,482,228 B1
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`
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`Figures 18 and 19 of the ’228 patent illustrate an embodiment of
`valve 100 incorporating a tissue material.
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`As shown in Figures 18 and 19, cadaver/porcine, or tissue, valve 100 is
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`retained in base ring 102. Ex. 1001, col. 6, l. 1. Ring 102 is made of a pliable
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`biocompatible material which seals against the root of native aortic valve 34. Id. at
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`col. 6, ll. 2–4. Valve 100 is anchored along the root of the aortic valve by
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`connecting rods 104 connected to ascending aortic stents 28. Id. at col. 6, ll. 4–6.
`
`C. Illustrative Claim
`
`Claim 20 of the ’228 patent is the only independent claim challenged in the
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`Petition. Challenged claims 2124 depend directly or indirectly from independent
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`claim 20. Claim 20, shown below, is illustrative of the claimed invention:
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`20. An aortic valve for controlling a blood flow through an
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`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;
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`Case IPR2014-00111
`Patent 6,482,228 B1
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`
` means for maintaining said ring member in said seated
`position about the aortic wall,
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`said tissue valve interior member responsive to changes of
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`conditions within the aorta for movement of said opening
`between a first closed position and a second open position.
`
`II. ANALYSIS
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are interpreted
`
`according to their broadest reasonable construction in light of the specification of
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`the patent in which they appear. 37 C.F.R. § 42.100(b); accord In re Cuozzo Speed
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`Technologies LLC, 778 F.3d 1271, 1278–82 (Fed. Cir. 2015) (“Congress implicitly
`
`adopted the broadest reasonable interpretation standard in enacting the AIA,” and
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`“the standard was properly adopted by PTO regulation.”). Claim terms also are
`
`given their ordinary and customary meaning, as would be understood by one of
`
`ordinary skill in the art in the context of the entire disclosure. In re Translogic
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`Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
`
`If an inventor acts as his or her own lexicographer, the definition must be set
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`forth in the specification with reasonable clarity, deliberateness, and precision.
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`Renishaw PLC v. Marposs Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed. Cir.
`
`1998). If a feature is not necessary to give meaning to what the inventor means by
`
`a claim term, it would be “extraneous” and should not be read into the claim.
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`Renishaw PLC, 158 F.3d at 1249; E.I. du Pont de Nemours & Co. v. Phillips
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`Petroleum Co., 849 F.2d 1430, 1433 (Fed. Cir. 1988).
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`Only terms which are in controversy need to be construed, and then only to
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`the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. &
`
`Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
`
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`Case IPR2014-00111
`Patent 6,482,228 B1
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`Against this background of general principles, we construe relevant terms in
`
`the ’228 patent.
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`Petitioner proposes specific constructions for the claim terms “tissue” and
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`“means for maintaining.” Pet. 8. Patent Owner does not propose any specific
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`claim constructions in the Patent Owner Response.
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`1. “Tissue”
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`Petitioner proposes that the claim term “tissue” is a “biological tissue, such
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`as cadaver and porcine tissue.” Pet. 8.
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`The written description in the ’228 patent uses the word “tissue” only once.
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`Ex. 1001, col. 5, l. 64. This sole use is in the context of describing various valve
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`designs and states that “designs which may prove valuable” to the “technique”
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`disclosed in the written description include the use of “biological tissue
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`incorporated valves, such as cadaver/porcine valves placed within a percutaneously
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`stented system.” Id. at col. 5, ll. 63–66. The Specification refers to Figures 18 and
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`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 the term “tissue” without specifying the type of tissue or
`
`the source of the tissue, e.g., “cadaver” or “porcine” tissue. “While . . . claims are
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`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
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`into the claims.” Comark Commc’ns, Inc. v. Harris Corp., 156 F.3d 1182, 1186
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`(Fed. Cir. 1998) (citation omitted), see also Texas Instruments, Inc. v. United
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`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
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`
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`construction in light of the Specification of the claim term “tissue” is “biological
`
`tissue.”
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`2. “Means for Maintaining”
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`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 ¶ 6.3 Pet. 8. 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 “means for
`
`maintaining” is a “means plus function” phrase that is interpreted under § 112 ¶ 6.
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`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., 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
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`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-
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`plus-function” language. Id. at 1194–95. The structure disclosed in the written
`
`
`3 Section 4(c) of the Leahy-Smith America Invents Act (“AIA”) re-designated 35
`U.S.C. § 112 ¶ 6, as 35 U.S.C. § 112(f). Pub. L. No. 112-29, 125 Stat. 284, 296
`(2011). Because the ’228 patent has a filing date before September 16, 2012
`(effective date of § 4(c)), we will refer to the pre-AIA version of § 112.
`
`
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`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.
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`B. Braun Med. Inc., v. Abbott Labs., 124 F.3d 1419, 1424 (Fed. Cir. 1997). Claim
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`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.
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`The function recited in the “means for maintaining” of claim 20 is
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`“maintaining said ring member in said seated position about the aortic wall.”
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`Ex. 1001, col. 8, ll. 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
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`seated position about the aortic wall.
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`Petitioner asserts that the structure described in the ’228 patent for
`
`performing the claimed function is “connecting rods 104,” which anchors valve
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`100 along the root of the aortic valve. Pet. 8 (citing Ex. 1001, col. 6, ll. 4–5).
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`Petitioner, thus, concludes that the “means” for performing the claimed function is
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`“connecting rods” or an equivalent structure. Id.
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`Patent Owner does not argue a specific construction for the “means for
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`maintaining phrase, but states that “[t]he “means for maintaining” disclosed in
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`claim 20 is “rods 104 interacting with stent 28.” PO Resp. 27. This is the
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`construction adopted in the Decision to Institute. Decision 9. Petitioner suggests
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`that a “more precise” construction than the construction in our Decision to Institute
`
`is “rods 104 to interact with stent 28.” Pet. Reply 3, n. 1.
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`As explained below, we maintain and adopt the claim construction for the
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`“means for maintaining” phrase stated in our Decision to Institute.
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`Based on Petitioner’s suggested “more precise” construction, the parties’
`
`constructions for the “means for maintaining” phrase appear to be similar, but, in
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`fact, are very different. Petitioner asserts that the challenged claims are limited to
`
`an aortic valve. Pet. Reply 3, n. 1(“the claims are directed to the ‘aortic valve’ and
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`not a valve/stent combination”); see also, Tr. 15, ll. 17–23 (“[t]he claims are all
`
`directed to a valve . . . [t]he claims are really directed to the valve alone”). Thus,
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`Petitioner’s proposed construction, including the “more precise” suggestion in
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`Petitioner’s Reply (Pet. Reply 3, n. 1), does not include the stent as an element of
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`the “means for maintaining” phrase.
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`Patent Owner agrees that claim 164 is directed solely to the valve, but
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`maintains that claims which recite the “means for maintaining” clause, which
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`includes all the claims challenged in this proceeding, are directed to the
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`combination of a valve and stent. Tr. 36, l. 13–Tr. 37, l. 21.5 Patent Owner asserts
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`that “the rods cannot maintain the valve in place by itself. It is the interaction with
`
`the stent system” that maintains ring member in a seated position about the aortic
`
`wall. Tr. 36, ll. 19–20. We are persuaded that Patent Owner’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
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`cylindrical lattice or scaffolding. Ex, 1001, col. 2, ll. 61–63. In the context of the
`
`
`4 Claim 16 is not challenged in this proceeding.
`5 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.”
`
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`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 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), col. 5, ll. 21–23 (valve 66 is
`
`anchored with rods 80), col. 5, ll. 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.
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`Ex. 1001, col. 1, ll. 30–31, 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.
`
`The function recited in the “means for maintaining” in claim 20 is
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`maintaining the ring member in a “seated position about the aortic wall.”
`
`Ex. 1001, col. 8, ll. 37–38 (emphasis added). The written description in 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 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, col. 6, ll. 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
`
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`an aortic channel. Id., col. 8, ll. 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., col. 8, ll. 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 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, col. 3, ll. 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, in the context of the tissue valve disclosed
`
`in Figures 18 and 19, 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,
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`it is rods 104 interacting with stent system 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. We are not
`
`persuaded to modify this construction as suggested by Petitioner.
`
`3. Ring Member
`
`The parties dispute whether the phrase “ring member,” as used in the
`
`challenged claims, means a ring made of a pliable, biocompatible material.
`
`Petitioner asserts that the “[r]ing member is not limited to a pliable material.”
`
`Tr. 5, l. 20–Tr. 6, l. 8; Ex. 1026 ¶¶ 39–42. Patent Owner asserts exactly the
`
`opposite, asserting that the ring member “has to be a pliable ring member.” Tr. 38,
`
`ll. 1–7; Ex. 2195 ¶ 33. Patent Owner’s explanation of its position is that, unless the
`
`ring member is pliable, “the ring member does not adapt to the aortic channel. The
`
`aortic channel adapts to that ring member.” Tr. 38, ll. 1–7.
`
`Claim 20 states that the ring member is “adapted to seat” about an aortic
`
`wall. Claim 24 states that the ring member contacts the wall of the aortic channel
`
`and seals against the aortic channel. We are not directed to any persuasive
`
`evidence that supports Patent Owner’s position that the claims require the ring
`
`member to adapt or conform to the channel. The ring member must seat against
`
`the aortic wall (claim 20) or seat against the aortic wall and also seal against the
`
`aortic channel (claim 24). The specific implementation as to how it achieves the
`
`seated or sealed configuration is not recited in the claims.
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`Petitioner’s Declarant, Alexander J. Hill, Ph.D.,6 opined that:
`
`while pliability could be a factor relating to a sealing function,
`heart valve seals are often created with relatively rigid ring
`structures. This can be easily achieved because the aorta itself is
`pliable and will conform to the shape of a relatively rigid heart
`valve ring member. In addition, besides pliability, several other
`factors relate to a sealing function with the aorta, such as the
`surface area of the ring and amount of contact with the aorta.
`
`Ex. 1026 ¶ 41. Thus, according to Dr. Hill, the ring need not be “pliable” because
`
`the aorta itself is pliable.
`
`In the context of stating his opinion about the interpretation of claim 20,
`
`Patent Owner’s Declarant, Timothy T. Catchings, M.D.,7 opined that the ring
`
`member recited in claim 20 means “a ring made of pliable, biocompatible
`
`material.” Ex. 2195 ¶ 33. Dr. Catchings also opined that “the ring member has a
`
`pliable circumference in order to seat about the aortic wall and seal against the root
`
`of the native aortic valve to reduce perivalvular leaks.” Id. ¶ 39 (emphasis added).
`
`As discussed above, there is no requirement in claim 20 that the ring member seal
`
`against anything.
`
`Based on the arguments and evidence, including the differing views of two
`
`expert declarants, we decline to limit the “ring member” to a specific material, as
`
`proposed by Patent Owner. There is no argument or evidence asserted by Patent
`
`
`6 Dr. Hill is a Senior Research Manager in the Cardiac and Vascular Group,
`Coronary and Structural Heart, for Petitioner Medtronic, Inc. Id. ¶ 11. He is also a
`Clinical Assistant Professor, Department of Surgery, at the University of
`Minnesota Medical School. Id. ¶ 10. He has approximately 15 years of experience
`in this field. Id. ¶¶ 7–20. Dr. Hill earned a Ph.D. degree in Biomedical
`Engineering in 2004.
`7 Dr. Catchings is a Board certified interventional cardiologist. Id. ¶ 6. He earned
`his medical degree in 1978. Dr. Catchings also is a Retired Captain in the Medical
`Corps of the U.S, Navy Reserve, and served in various medical positions with the
`Navy before entering private medical practice. Id. ¶¶ 8–9.
`
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`Owner that persuades us to read limitations concerning the material from which the
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`ring member is made from the Specification into the claims. Comark Commc’ns,
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`156 F.3d at 1186 (“limitations from the specification are not to be read into the
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`claims”); Texas Instruments, 805 F.2d at 1563 (“This court has cautioned against
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`limiting the claimed invention to preferred embodiments or specific examples in
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`the specification.”).
`
`B. Asserted Grounds of Unpatentability
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`1. Anticipation of Claims 20–24 by Schreck
`
`Petitioner asserts that “each element recited in claims 20–24 is anticipated
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`by Schreck,” which qualifies as prior art under 35 U.S.C. § 102(e). Pet. 15.
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`Patent Owner asserts two reasons why Schreck does not anticipate claims
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`2024 of the ’228 patent. First, according to Patent Owner, Schreck does not
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`anticipate the challenged claims “because Norred [the inventor and Patent Owner]
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`conceived his invention prior to Schreck, and exercised reasonable diligence in
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`constructively reducing it to practice.” PO Resp. 6–7. Second, Patent Owner
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`asserts that “Schreck does not disclose all of the prior art elements as arranged in
`
`claims 20–24.” Id. at 7.
`
`“A claim is anticipated only if each and every element as set forth in the
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`claim is found, either expressly or inherently described, in a single prior art
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`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.
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`1989). The elements must be arranged as required by the claim, but this is not an
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`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
`
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`limitations arranged or combined in the same way as recited in the claim, it cannot
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`be said to prove prior invention of the thing claimed and, thus, cannot anticipate
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`under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371
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`(Fed. Cir. 2008).
`
`a. Conception and Diligence
`
`Schreck was filed on April 6, 2000, and issued on September 24, 2002. The
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`application that matured into the ’228 patent was filed on November 14, 2000.
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`Schreck is available as prior under 35 U.S.C. §102(e)(2) as of April 6, 2000,
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`against the challenged claims unless Patent Owner establishes that the invention in
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`the challenged claims was invented before April 6, 2000 and diligently reduced to
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`practice as of the filing date, November 14, 2000.8
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`Patent Owner asserts that the invention in the challenged claims was
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`conceived no later than December 21, 1998 (PO Resp. 8) and was diligently
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`reduced to practice from the conception date until the application that matured into
`
`the ’228 patent was filed on November 14, 2000 (id. at 13).9 Patent Owner bears
`
`the burden to establish the facts necessary to overcome Schreck’s filing date. In re
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`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
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`burden on the party claiming prior invention to overcome that reference). Patent
`
`Owner may meet its burden by providing evidence that the effective date of the
`
`
`8 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)
`9 Page 13 of Patent Owner’s Response states November 20, 2000, as the
`application filing date. The application filing date of the ’228 patent is November
`14, 2000. Ex. 1001, Cover Page.
`
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`reference is not “before the invention by the applicant for patent,” that is,
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`antedating the Schreck reference. 35 U.S.C. § 102(e) (2000).
`
`We evaluate Patent Owner’s arguments and evidence to establish an
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`invention date prior to April 6, 2000, under the general standards established in
`
`37 C.F.R. § 1.131. Rule 131(a) states:
`
`When any claim of an application or a patent under
`reexamination is rejected, the inventor of the subject matter of
`the rejected claim, [or]
`the owner of
`the patent under
`reexamination . . ., 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.”
`
`37 C.F.R. § 1.131(a). The standards by which we evaluate the invention date
`
`claimed are stated in Rule 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
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`inventor, of a definite and permanent idea of the complete and operative invention,
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`as it is to be thereafter to be applied in practice.” Dawson v. Dawson, 710 F. 3d
`
`1347, 1352 (Fed. Cir. 2013). 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
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`definite and permanent when the inventor has a specific, settled idea, a particular
`
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`solution to the problem at hand, not just a general goal or research plan he hopes to
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`pursue.” Id.
`
`Patent Owner asserts that the invention was conceived “no later than
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`December 21, 1998.” PO Resp. 8 (citing Ex. 2103 and Ex. 2193 ¶ 27). According
`
`to Petitioner, Exhibit 2103 “depicts each limitation set forth in claims [20–24] of
`
`the ’228 Patent.” Id.
`
`Exhibit 2103 is a sketch dated “12/21/98.” Exhibit 2103, annotated to
`
`identify more clearly the labeled elements, is reproduced below.
`
`“nitinol self expanding stent”
`
`“Aortic valve”
`
`“One example sutured
`bioprosthetic valve”
`
`Exhibit 2103 is notarized as being signed by “Troy Norred” on December
`
`21, 1998. Patent Owner states that Exhibit 2103 shows “the stent system as
`
`
`
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`deployed in the aorta, attached through connecting rods to the ring member.” PO
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`Resp. 11.
`
`Petitioner asserts that Ex. 2103 “only identifies two elements of a device to
`
`be inserted into the aorta: (1) a ‘nitinol self-expanding stent’ that ‘expands to the
`
`shape of the aorta and sinus’; and (2) a ‘sutured bioprosthetic valve.’” Pet. Reply
`
`4. According to Petitioner, Exhibit 2103 fails to show a ring member surrounding
`
`a tissue valve (id.), or rods interacting with a stent to form the “means for
`
`maintaining” structure discussed above. Both the ring member and the “means for
`
`maintaining” are required in claims 20–24.
`
`We agree with Petitioner that 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