Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 13
`Entered: June 27, 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 IPR2014-00395
`Patent 6,482,228 B1
`
`
`
`
`
`
`
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`WEATHERLY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`INTRODUCTION
`
`A. Background
`
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
`
`LLC (collectively “Medtronic” or “Petitioner”) filed a petition (Paper 4,
`
`“Pet.”) requesting an inter partes review of claims 16 and 19–24 (the
`
`“challenged claims”) of U.S. Patent 6,482,228 B1 (Exhibit 1001, the “’228
`
`patent”). 35 U.S.C. § 311. Troy R. Norred, M.D. (“Dr. Norred” or “Patent
`
`
`
`
`Tel: 571-272-7822
`
`Paper 13
`Entered: June 27, 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 IPR2014-00395
`Patent 6,482,228 B1
`
`
`
`
`
`
`
`
`
`Before WILLIAM V. SAINDON, MICHAEL R. ZECHER, and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`WEATHERLY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`INTRODUCTION
`
`A. Background
`
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
`
`LLC (collectively “Medtronic” or “Petitioner”) filed a petition (Paper 4,
`
`“Pet.”) requesting an inter partes review of claims 16 and 19–24 (the
`
`“challenged claims”) of U.S. Patent 6,482,228 B1 (Exhibit 1001, the “’228
`
`patent”). 35 U.S.C. § 311. Troy R. Norred, M.D. (“Dr. Norred” or “Patent
`
`
`
`
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`Case IPR2014-00395
`Patent 6,482,228 B1
`
`Owner”) timely filed a Preliminary Response. Paper 11 (“Prelim. Resp.”).
`
`The standard for instituting an inter partes review is set forth in 35 U.S.C.
`
`§ 314(a), which provides as follows:
`
`(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.
`
`35 U.S.C. § 314(a).
`
`Based on our review of the record, we conclude that Medtronic is
`
`reasonably likely to prevail in demonstrating that at least one of the
`
`challenged claims is not patentable.
`
`Medtronic contends that the challenged claims are unpatentable under
`
`35 U.S.C. § 102 based on the following grounds (Pet. 9–28 and App.):
`
`References
`
`Basis
`
`Claims challenged
`
`U.S. Patent No. 5,957,949, (“Leonhardt”)
`(Ex. 1004)
`
`§ 102(b) 16 and 19–24
`
`U.S. Patent No. 5,411,552, (“Andersen”)
`(Ex. 1005)
`
`§ 102(b) 16 and 19–24
`
`U.S. Patent No. 6,458,153 B1, (“Bailey”)
`(Ex. 1006)
`
`§ 102(b) 16 and 19–24
`
`German Application No. DE 195 46 692,
`(“Figulla”) (Ex. 1007 with English
`translation at Ex. 1008)
`
`§ 102(b) 16 and 19
`
`U.S. Patent No. 5,855,597, (“Jayaraman”)
`(Ex. 1009)
`
`§ 102(b) 16 and 19
`
`U.S. Patent No. 3,657,744, (“Ersek”)
`(Ex. 1010)
`
`§ 102(b) 16 and 19
`
`2
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`Patent 6,482,228 B1
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`For the reasons described below, we institute an inter partes review of
`
`claims 16 and 19–24 based on anticipation by Leonhardt or Bailey. We
`
`decline to institute an inter partes review of claims 16 and 19–24 on the
`
`remaining alleged grounds of unpatentability because we find those grounds
`
`to be redundant to the grounds on which we institute review.
`
`B. Related Proceedings
`
`Medtronic and Dr. Norred identified, as related proceedings, the co-
`
`pending litigation titled Troy R. Norred, M.D. v. Medtronic, Inc., et al., No.
`
`2:13-CV-02061 (D. Kan.). Pet. 1; Prelim. Resp. 5. Proceedings before the
`
`Board involving the same parties including IPR2014-00110 and IPR2014-
`
`00111 also are identified as related proceedings. Pet. 1; Prelim. Resp. 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
`
`and 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.
`
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`Valve 66 consists of interconnected fingers 68, a generally ring-
`
`shaped base 70, and a ring 72 secured to the 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), and 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, and 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
`
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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.
`
`A. Priority of invention
`
`ANALYSIS
`
`Dr. Norred contends he conceived of his invention no later than
`
`December 1998. Prelim. Resp. 11 (citing Ex. 2203). Dr. Norred draws our
`
`general attention to Exs. 2201–79 as documentary evidence demonstrating
`
`reasonable diligence between the date of conception and filing date for the
`
`patent application. Prelim. Resp. 8–15. Dr. Norred, however, does not
`
`explain sufficiently the content of the exhibits. Dr. Norred also does not
`
`map sufficiently each claim limitation to supporting evidence in a manner
`
`that would enable us to determine if there had been an actual reduction to
`
`practice of the claimed subject matter. For example, Dr. Norred contends
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`that the figure presented in Ex. 2203 is similar to Figure 4 of the ’228 patent.
`
`We note, however, that Figure 4 is not relied upon in the ’228 patent to
`
`illustrate the feature of a ring member. See, e.g., Ex. 1001, 3:1–13.
`
`Accordingly, at this stage in the proceeding, we are not persuaded that the
`
`claims of the ’228 patent are entitled to a priority date earlier than November
`
`14, 2000.
`
`B. Claim Interpretation
`
`As a step in our analysis for determining whether to institute a trial,
`
`we interpret the claims. Consistent with the statute and the legislative
`
`history of the AIA, we analyze patentability using the broadest reasonable
`
`interpretation of the claims. See Office Patent Trial Practice Guide, 77 Fed.
`
`Reg. 48,756, 48,766 (Aug. 14, 2012); 37 CFR § 42.100(b).
`
`Under the broadest reasonable interpretation standard, we interpret
`
`claim terms according to their ordinary and customary meaning as they
`
`would have been understood by one of ordinary skill in the art at the time of
`
`the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
`
`2007). “Absent claim language carrying a narrow meaning, the PTO should
`
`only limit the claim based on the specification . . . when [it] expressly
`
`disclaim[s] the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed.
`
`Cir. 2004). “Although an inventor is indeed free to define the specific terms
`
`used to describe his or her invention, this must be done with reasonable
`
`clarity, deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480
`
`(Fed. Cir. 1994).
`
`We have interpreted all terms according to their ordinary meaning as
`
`an ordinarily skilled artisan would have understood them in light of the ’228
`
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`patent. For clarity in this Decision, however, we explicitly set forth the
`
`ordinary meaning for the following terms.
`
`1. Ring Member
`
`“Ring member” appears in independent claims 16 and 20 and, thus, in
`
`all challenged claims. Dr. Norred proposes that the phrase “ring member”
`
`means “a ring made of a pliable, biocompatible material which seals against
`
`the aorta to reduce peri-valvular leaks.” Prelim. Resp. 16–17. Dr. Norred
`
`cites the Specification as support for this proposed claim interpretation. Id.
`
`(citing Ex. 1001, 1:26–51, 6:1–9). Medtronic does not propose an explicit
`
`interpretation for “ring member.”
`
`We do not interpret “ring member” as limited to a specific material.
`
`Claims 16 and 19–24 do not recite the material from which the ring member
`
`is made, and Dr. Norred cites no persuasive evidence that we should import
`
`into the claims limitations from the Specification regarding the material
`
`from which the ring member is made. Dr. Norred also 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 interpret “ring member” as requiring that the ring
`
`member “seals against the aorta to reduce peri-valvular leaks.” Claims 16
`
`and 20–241 state that the outer circumference of the ring member is “adapted
`
`to seat . . . about an aortic wall surrounding an aortic channel.” Ex. 1001,
`
`8:1–2 (emphasis added). The challenged claims 16 and 19–23 do not state
`
`that the ring member seals against anything.
`
`
`1 We interpret “ring member” as recited in claim 16 to be consistent with our
`interpretation of “ring member” in claim 20.
`
`7
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`Additionally, dependent claim 24 further limits the ring member to
`
`one that not only seats but also “seals said ring against the aortic channel
`
`wall to reduce blood flow therearound.” Id. at 8:57–59. As a dependent
`
`claim, claim 24 must further limit claim 20 from which it depends. 35
`
`U.S.C. § 112, paragraph 4. 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. See,
`
`e.g., Ex. 1001, 5:17–21 (“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. Dr. Norred has not provided any
`
`persuasive argument or evidence that we should ignore the language of the
`
`claims as written and interpret the claim as he proposes. 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.”).
`
`For purposes of this Decision, “ring member” as recited in claims 16
`
`and 19–23 does not require a particular sealing function. We do, however,
`
`interpret claim 24 to require that the ring member seals against the aortic
`
`wall sufficiently to reduce blood flow around the ring member, because the
`
`claim explicitly requires the ring member to so seal.
`
`2. Membrane
`
`“Membrane” appears in claim 16 and its dependent claim 19.
`
`Medtronic contends that the term “membrane” should be construed to
`
`include fabrics or polymers, but not tissue. Pet. 12–13. As support for this
`
`8
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`position, Medtronic relies on particular embodiments of aortic valves having
`
`fabric and polymer membranes disclosed in the Specification. Id. (citing
`
`Ex. 1001, 4:59–62 and 5:40–41). Nevertheless, the Specification also
`
`describes valves with membranes comprising biological tissue. Ex. 1001,
`
`5:63–6:9.
`
`We decline to limit the term “membrane” as Medtronic proposes. The
`
`disclosure of specific embodiments does not, by itself, require a narrow
`
`interpretation of a claim term. We find no evidence on this record
`
`suggesting that the term “membrane” excludes a tissue membrane.
`
`3. Tissue
`
`“Tissue” appears in independent claim 20 and its dependent claims
`
`21–24. Medtronic proposes that the claim term “tissue” is a “biological
`
`tissue, such as cadaver and porcine tissue.” Pet. 14. Dr. Norred proposes
`
`the identical construction. Prelim. Resp. 17.
`
`The written description in the ’228 patent uses the word “tissue” only
`
`once. Ex. 1001, 5:64. 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 stented system.” Id. at 5:63–66. The Specification
`
`refers to Figures 18 and 19, which illustrate “a cadaver/porcine incorporated
`
`valve and stent system.” Id. at 5:67; 2:48–51.
`
`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
`
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`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 interpretation in light of the Specification of the claim term
`
`“tissue” is generally “biological tissue.”
`
`4. Means for Mounting
`
`Claim 16 recites a means for mounting a first open end of a membrane
`
`about a ring aperture. “Means for mounting” is a “means plus function”
`
`limitation to be construed under 35 U.S.C. § 112, sixth paragraph. It is well
`
`established that the use of the term “means” triggers a rebuttable
`
`presumption that § 112, sixth paragraph, 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, the parties agree that “means for
`
`mounting” is a “means plus function” phrase to be interpreted under § 112,
`
`sixth paragraph. Pet. 13; Prelim. Resp. 18.
`
`“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–
`
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`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, sixth paragraph, 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).
`
`A challenger who seeks to demonstrate that a means-plus-function
`
`limitation was present in the prior art must prove that the corresponding
`
`structure—or an equivalent—was present in the prior art. Fresenius USA,
`
`Inc. v. Baxter Intern., Inc., 582 F. 3d 1288, 1299 (Fed. Cir. 2009).
`
`Medtronic and Dr. Norred generally agree that the ’228 patent
`
`discloses that the membrane is “hingedly secured” (Ex. 1001, 4:56–61) or
`
`“hingedly attached” (id. at 5:35–39) about the aperture of the ring. Compare
`
`Pet. 13 with Prelim. Resp. 18. We understand the parties’ position to be that
`
`the structure required is a hinge. This proposed construction of the “means
`
`for mounting” is the broadest reasonable interpretation at this stage of the
`
`proceeding and we therefore adopt it for the purposes of this decision.
`
`5. Means for Maintaining
`
`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.” Dr. Norred contends that the
`
`“means for maintaining” is stent system 28 or an equivalent structure.
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`Prelim. Resp. 18 (citing Ex. 1001, 1:29–31, 59–67, 5:22–25, 48–51).
`
`Medtronic contends that Dr. Norred “seems to have ignored the means plus
`
`function strictures of this claim [term].” Pet. 14. Medtronic also concedes
`
`that Dr. Norred’s proposed construction of “means for maintaining” “is the
`
`construction applied to the limitation for purposes of this inter partes
`
`review.” Id.
`
`The Federal Circuit’s decision in In re Donaldson Co., Inc., 16 F.3d
`
`1189 (Fed. Cir. 1994) (en banc) demands otherwise. “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.” Id. at 1193. This is the “broadest reasonable
`
`interpretation” of “means-plus-function” language. Id. at 1194–95.
`
`Therefore, we look to the Specification of the ’228 patent to identify
`
`structures that perform the “maintaining” function.
`
`The ’228 patent discloses four valve designs: (1) figures 6–9 disclose
`
`an umbrella aortic valve; (2) figures 10–13 disclose a cone-shaped aortic
`
`valve; (3) figures 14–17 disclose another version of a cone-shaped valve;
`
`and (4) figures 18–19 disclose a cadaver/porcine valve. Ex. 1001, 2:24–51.
`
`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. Id. at 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 with rods 104 connected to stents 28. Id. at 6:4–6; see also id. at
`
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`4:6–9 (rod 56 on valve 30); id. at 5:21–23 (valve 66 is anchored with rods
`
`80); id. at 5:47–50 (valve 82 is anchored with connecting rods, not shown).
`
`Based on the review of the specification summarized above, it appears
`
`that it is the combination of rods 104 interacting with stent 28 that is the
`
`structure comprising the “means for maintaining” called for in claims 19–24.
`
`We therefore adopt this construction for the term “means for maintaining”
`
`for the purposes of this Decision.
`
`C. The Challenges to Patentability
`
`Medtronic contends that each of Leonhardt, Andersen, and Bailey
`
`anticipate all challenged claims. Pet. 15–21. Medtronic also contends that
`
`each of Figulla, Jayaraman, and Ersek anticipate claims 16 and 19. Pet. 22–
`
`27. “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
`
`(Fed. Cir. 1987). With this standard in mind, we address each alleged
`
`anticipation challenge below.
`
`1. Leonhardt—Claims 16 and 20–24
`
`Leonhardt generally describes a percutaneously placed artificial valve
`
`“to maintain bodily fluid flow in a single direction” and “be placed
`
`anywhere 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.
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`Figure 3 depicts Leonhardt’s valve stent 20 “fully deployed
`with the aorta above the aortic valve.” Leonhardt’s Figure 4
`depicts a partial sectional view of valve stent 20 incorporating
`porcine valve 22.
`
`
`
`Id. at 3:59–62, 6:23–33.
`
`Medtronic contends that Leonhardt discloses the claimed aortic valve
`
`and provides claim charts that identify in detail how Leonhardt’s description
`
`of its artificial valve discloses each element of all challenged claims.
`
`Pet. 15, Appendix A-1.2 Medtronic also provides the Declaration of Dr.
`
`Thomas Vassiliades, Jr., in which Dr. Vassiliades testifies that Leonhardt’s
`
`artificial valve inherently operates to open and close in response to the
`
`pressure gradient created by the heart during systole and diastole. Ex. 1018
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`¶¶ 20–28. This testimony is related to the claimed features of the valve set
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`forth in dependent claims 21–23. Dr. Norred admits that Leonhardt
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`describes these claimed features. Prelim. Resp. 34–35.
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`Dr. Norred contends that Leonhardt does not anticipate the challenged
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`claims because Leonhardt fails to describe the “means for maintaining”
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`recited in claims 19–24 or the “ring member” recited in claims 16 and 19–
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`2 We note that the Appendix is a section within the Petition having separate
`pagination, and not a separate document.
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`Patent 6,482,228 B1
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`24. Regarding the “means for maintaining,” Dr. Norred contends that
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`Leonhardt describes a stent structure that, except for distensible fingers,
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`“must be below the coronary artery.” Prelim. Resp. 20 (citing Ex. 1004,
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`5:40–52, Figure 2). Dr. Norred’s contention rests upon the presumption that
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`the “means for maintaining” imposes specific requirements on the location
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`at which a valve is positioned within the aorta. We disagree because the
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`“means for maintaining” refers to specific structures of the claimed aortic
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`valve that maintain the ring member seated “about the aortic wall,” rather
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`than a specific location within the aorta relative to coronary arteries.
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`Dr. Norred also contends that Leonhardt fails to describe the “ring
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`member” recited in claims 16 and 19–24 because Leonhardt’s stent structure
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`does not “seal the device against the aorta and reduce perivalvular leaks.”
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`Prelim. Resp. 21. More specifically, Dr. Norred contends that the seal
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`created by Leonhardt’s adhesive coating “ultimately degrades” and “differs
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`markedly” from the use of radial force described in the ’228 patent. Id. We
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`find Dr. Norred’s contention unpersuasive in connection with claims 16 and
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`19–23 because those claims do not require that the ring member seal the
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`device against the aortic wall.
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`Claim 24 recites that the “ring member contacts the wall of the aortic
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`channel and seals said ring against the aortic channel wall to reduce blood
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`flow therearound.” Nevertheless, Medtronic points out that Leonhardt
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`describes that the “valve graft may be completely sealed to the living tissue
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`by light activated biocompatible tissue adhesive between the outside of the
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`tubular graft and the living tissue.” Pet. App. A-1, p. 6 (citing Ex. 1004,
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`3:42–45). Thus, at this stage of the proceeding, we are not persuaded by Dr.
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`Norred’s argument that Leonhardt fails to describe the “ring member” of
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`claims 16 and 19–24.
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`We determine, on the record before us, that Medtronic has
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`demonstrated a reasonable likelihood of prevailing in establishing that
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`Leonhardt anticipates claims 16 and 19–24.
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`2. Bailey—Claims 16 and 19–24
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`Dr. Norred asserts that “Bailey does not constitute prior art and cannot
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`serve as a basis to invalidate the ’228 Patent pursuant to 35 U.S.C.
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`§ 102(e).” Prelim. Resp. 23. The basis for this assertion is that “Bailey was
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`filed on December 31, 1999, approximately one year after Norred invented
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`the aortic valve described in the ’228 Patent.” Id.
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`The effective filing date of Bailey is December 31, 1999. Ex. 1006 at
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`(22). The filing date of the ’228 patent is November 14, 2000. Ex. 1001 at
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`(22). Thus, Bailey is prior art under the applicable provision of 35 U.S.C.
`
`§ 102(e) unless Dr. Norred establishes that the inventions in the challenged
`
`claims were invented before December 31, 1999.
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`Patent Owner cites Exhibit 2203 in support of the asserted date of
`
`invention one year prior to Bailey’s filing date. Prelim. Resp. 23. Exhibit
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`2203 is a sketch dated “12/21/98.” The sketch is notarized as being signed
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`by “Troy Norred” on December 21, 1998. The sketch shows an “aortic
`
`valve” positioned in the aorta. Dr. Norred states that Exhibit 2203 “clearly
`
`depicts a percutaneous aortic heart valve held in place with a stent system,”
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`and “bears a striking similarity to Figure 4 of the ’228 patent.” Id. at 10.
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`Exhibit 2203 does not address the limitations of claims 16 and 19–24
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`and does not establish possession of every feature recited in these claims.
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`For example, there is no evidence that the sketch illustrates a “tissue valve,”
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`or that the sketch illustrates rods interacting with a stent that form the
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`structure comprising the “means for maintaining” called for in claims 19 and
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`20. As such, the evidence on which Patent Owner relies does not establish
`
`that the invention in claims 16 and 19–24 was invented prior to December
`
`31, 1999. Thus, based on the evidence and arguments asserted by Dr.
`
`Norred at this stage of the proceeding, we consider Bailey to be prior art to
`
`the challenged claims under 35 U.S.C. § 102(e).
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`Bailey generally describes a prosthetic cardiac valve comprising stent
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`support member 12, graft member 11 covering at least a portion of stent 12,
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`and biological xenograft valve flaps/leaflets 28. Pet. 20 (citing Ex. 1006,
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`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.
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`Ex. 1006, 6:44–49. Bailey’s artificial valve is implanted in the location of
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`the natural aortic valve. Id. at 10:31–44, figs. 6A and 6B. Medtronic
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`contends that Bailey discloses the claimed aortic valve and provides claim
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`charts that identify in detail how Bailey’s description of its artificial heart
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`valve discloses each element of all challenged claims. Pet. 19–21, App. A-3.
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`Dr. Norred contends that Bailey fails to describe the ring member
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`recited in claims 16 and 19–24 because portions of Bailey’s stent body
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`member 12 “must be eliminated to prevent the coronary artery from being
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`blocked.” Prelim. Resp. 23. Dr. Norred argues that the elimination of
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`portions of Bailey’s stent body member 12 “creates gaps” and “prevents it
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`from sealing against the aorta to reduce perivalvular leaks.” Id. at 24. We
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`are not persuaded by Dr. Norred’s argument at this stage for two reasons.
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`First, Bailey’s stent body member 12 need not seal itself against the aortic
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`wall to meet the claimed “ring member.” See supra Part I.B.1. Second, Dr.
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`Norred provides no evidence to support the argument that Bailey’s structures
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`would seal the perimeter of the valve to the aortic wall.
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`Dr. Norred also contends that Bailey fails to describe the “means for
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`maintaining” recited in claims 19–24 because “the Bailey device anchors in
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`a very different fashion than Norred’s device.” Id. at 24–25. Dr. Norred
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`contends that Bailey’s device is held in place by anchor flange 22, which
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`extends radially outwardly, and that anchor flange 22 “likely would result in
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`the stent piercing the aortic wall.” Id. at 24. None of the portions of Bailey
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`that Dr. Norred cites support the latter contention. Additionally, Dr.
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`Norred’s argument ignores Bailey’s distal anchor section 16, which
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`“expands to contact the vascular wall and retain the prosthesis in position.”
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`Ex. 1006, 6:5–7. Differences between the manner in which Bailey’s and
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`Norred’s structures function to maintain the ring member in its seated
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`position about the aortic wall must be established by evidence rather than
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`attorney argument. See Glaverbel Societe Anonyme v. Northlake Mktg. &
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`Supply, Inc., 45 F.3d 1550, 1562 (Fed. Cir. 1995) (denying summary
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`judgment of infringement under doctrine of equivalents when alleged
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`equivalency of accused subject matter supported solely by attorney
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`argument). Therefore, at the current stage of the proceeding, Dr. Norred’s
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`contention is unsupported by evidence.
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`We determine, on the record before us, that Medtronic has
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`demonstrated a reasonable likelihood of prevailing in establishing that
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`Bailey anticipates claims 16 and 19–24.
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`3. The Remaining Challenges to Patentability
`
`As summarized in Part I.A above, Medtronic asserts six grounds of
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`unpatentability based on § 102. Under 37 C.F.R. § 42.108(a), we have
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`discretion to “authorize the review to proceed on all or some of the
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`challenged claims and on all or some of the grounds of unpatentability
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`asserted for each claim.” We also “may deny some or all grounds for
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`unpatentability for some or all of the challenged claims.” 37 C.F.R.
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`§ 42.108(b). In making such determinations, we consider 37 C.F.R
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`§ 42.1(b), which requires “the just, speedy, and inexpensive resolution of
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`every proceeding.”
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`We have determined to institute a trial on two of the six grounds
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`proposed by Medtronic. In this case, the decision not to authorize inter
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`partes review on the other four unpatentability challenges is based on our
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`determination that the challenges rely on substantially similar prior art facts
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`as the challenges for which inter partes review is authorized. Considering
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`multiple different references to establish the same factual premise, the
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`structure and function of a heart valve, would consume, unnecessarily, the
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`time and resources of the Board and all parties involved, as well as impede
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`“the just, speedy, and inexpensive resolution” of this proceeding. Medtronic
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`did not identify a persuasive, meaningful distinction between the two
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`challenges for which we institute review and the four challenges for which
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`we deny review due to redundancy.
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`CONCLUSION
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`For the foregoing reasons, based on the information presented in the
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`Petition and Preliminary Response, we determine that Medtronic has shown
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`a reasonable likelihood that it will prevail in establishing t
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