Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 10
`Entered: April 25, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`_______________
`
`Case IPR2014-00110
`Patent 6,482,228 B1
`_______________
`
`
`Before JOSIAH C. COCKS, SHERIDAN K. SNEDDEN, and
`BARRY L. GROSSMAN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 10
`Entered: April 25, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
`
`v.
`
`TROY R. NORRED, M.D.
`Patent Owner
`_______________
`
`Case IPR2014-00110
`Patent 6,482,228 B1
`_______________
`
`
`Before JOSIAH C. COCKS, SHERIDAN K. SNEDDEN, and
`BARRY L. GROSSMAN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`
`
`Case IPR2014-00110
`Patent 6,482,228 B1
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`I. INTRODUCTION
`
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
`
`LLC (collectively ―Medtronic‖) filed a corrected petition to institute an inter
`
`partes review of claims 16-19 (Paper 4; ―Pet.‖) of US 6,482,228 B1 (Ex. 1001;
`
`―the ’228 patent‖). Troy R. Norred, M.D. (―Dr. Norred‖) filed a patent
`
`owner preliminary response. Paper 9 (―Prelim. Resp.‖).
`
`We have jurisdiction under 35 U.S.C. § 6. The standard for instituting
`
`an inter partes review is set forth in 35 U.S.C. § 314(a), which states:
`
`THRESHOLD.—The Director may not authorize
`an inter partes review to be instituted unless the
`Director determines that the information presented
`in the petition filed under section 311 and any
`response filed under section 313 shows that there
`is a reasonable likelihood that the petitioner would
`prevail with respect to at least 1 of the claims
`challenged in the petition.
`
`Upon consideration of the above-mentioned petition and preliminary
`
`responses, we conclude that Petitioner has established that there is a
`
`reasonable likelihood that it will prevail with respect to at least one of the
`
`challenged claims. Accordingly, we grant the petition to institute an inter
`
`partes review as to claims 16-19.
`
`A. The ’228 Patent (Ex. 1001)
`
`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 13 of the ’228 patent are reproduced below.
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`Figures 10 and 13 show different views of a cone-shaped aortic valve
`
`in a closed position. The 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 34. 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 34 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. Id.
`
`at 5:21-23.
`
`B. Challenged Claims
`
`Challenged claims 16-19 are reproduced below:
`
`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
`
` 3
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`means for mounting said first open end of said membrane
`about said ring aperture with said second open end displaced
`therefrom, said means moving said membrane second end
`between a first open position
`to allow a blood flow
`therethrough and a second closed position to preclude a blood
`flow therethrough.
`
`17. The aortic valve as claimed in claim 16 wherein said
`mounting means comprises at least one arm having a first end
`hingedly secured to said ring member and a free end spaced
`therefrom, said first end of said at least one arm secured to said
`first end of said membrane, said free end of said at least one
`arm secured to said second end of said membrane, said at least
`one arm responsive to a blood flow within the channel for
`movement with said membrane between said first open and
`second closed positions.
`
`18. The aortic valve as claimed in claim 17 wherein said at least
`one arm extends generally along a path of said blood flow at
`said first open position, and generally traverses a blood flow
`path when at said second closed position.
`
`19. The aortic valve as claimed in claim 16 further comprising
`means for maintaining said ring member in said seat about the
`aortic wall.
`
`
`C. The Prior Art and Supporting Evidence
`
`Petitioner relies on the following prior art:
`
`DiMatteo, US 6,440,164 B1, published Aug. 27, 2002 (Ex. 1003).
`
`Kischer, US 3,548,417, published Dec. 22, 1970 (Ex. 1004).
`
`Shaolian, US 6,299,637 B1, published Oct. 9, 2001 (Ex. 1005).
`
`Wolfe, US 4,030,142, published Jun. 21, 1977 (Ex. 1006).
`
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`D. The Asserted Grounds
`
`Petitioner challenges claims 16-19 of the ’228 patent on the following
`
`grounds. Pet. 8.
`
`
`
`Reference[s] Basis
`
`Claims challenged
`
`DiMatteo
`
`§ 102(e)
`
`16-19
`
`Kischer
`
`§ 102(b)
`
`Shaolian
`
`§ 102(e)
`
`Wolfe
`
`§ 102(b)
`
`16-18
`
`16-19
`
`16-18
`
`
`
`A. Priority of Invention
`
`II. ANALYSIS
`
`Dr. Norred contends he conceived of his invention no later than
`
`December 1998. Prelim. Resp. 7 (citing Ex. 2003). Dr. Norred draws our
`
`general attention to Exs. 2001 to 2079 as documentary evidence
`
`demonstrating reasonable diligence between the date of conception and
`
`filing date for the patent application. Prelim. Resp. 8-13. Dr. Norred,
`
`however, does not sufficiently explain the contents of the exhibits.
`
`Dr. Norred also does not sufficiently map 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 that the figure presented in Ex. 2003 is similar
`
`to Figure 4 of the ’228 patent. We note, however, that Figure 4 is not relied
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`upon in the ’228 patent to illustrate the feature of a ring member. See e.g.,
`
`Ex. 1001, 3:1-13. Accordingly, we are not persuaded that the claims of the
`
`’228 patent are entitled to an earlier priority date.
`
`B. Claim Interpretation
`
`Consistent with the statute and legislative history of the America
`
`Invents Act (AIA), we interpret claims using the ―broadest reasonable
`
`construction in light of the specification of the patent in which [they]
`
`appear[].‖ 37 C.F.R. § 42.100(b); see also Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14, 2012).
`
`Under the broadest reasonable construction standard, claim terms are
`
`given their ordinary and customary meaning, as would be 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).
`
`All claim terms have been given their ordinary meaning as would be
`
`understood by a skilled artisan in light of the ’228 patent. For clarity in this
`
`Decision, however, we explicitly set forth the ordinary meaning for the
`
`following terms.
`
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`1. ―membrane‖
`
`Medtronic contends that the term ―membrane‖ should be construed to
`
`include fabrics or polymers, but not tissue. As support for this position,
`
`Medtronic relies on particular embodiments of aortic valves having fabric
`
`and polymer membranes disclosed in the specification of the ’228 patent.
`
`Pet. 8-9 (citing Ex. 1001, 4:59-62 and 5:40-41).
`
`We decline to limit the term ―membrane‖ as offered by Medtronic.
`
`The disclosure of specific embodiments does not, by itself, necessitate a
`
`narrow interpretation of a claim term. We find no evidence on this record
`
`suggesting that the term ―membrane‖ carries a meaning other than its
`
`ordinary and customary meaning. Medtronic offers no evidence that the
`
`ordinary and customary meaning of the term ―membrane‖ excludes a tissue
`
`membrane.
`
`2. ―ring member having a circumference adapted to seat about an
`aortic wall‖
`
`In the preliminary response, Dr. Norred sets forth what he considers to
`
`be the ordinary meaning for claim terms ―ring member having a
`
`circumference‖ in light of the specification. Prelim. Resp. 14 (citing
`
`Ex. 1001, 6:1-9). Dr. Norred construes ―ring member‖ to mean a ring made
`
`of a pliable, biocompatible material that seals against the aorta to reduce
`
`perivalvular leaks. Id. Medtronic does not provide a proposed construction
`
`for ―ring member.‖
`
`The ’228 patent does not set forth specific definitions for the claim
`
`terms ―ring member having a circumference‖ and we have no basis to
`
`conclude that the words of the claims should not be given their ordinary
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`meaning. We therefore give those terms their ordinary meaning: a ring
`
`having a circumference that is part of a larger structure. We decline to
`
`require the ring to be made of any particular material.
`
`We also give ordinary meaning to the terms ―adapted to seat about an
`
`aortic wall‖—that is, the ring is capable of sitting against the aortic wall.
`
`We decline to require the ring to necessarily form an immediate seal with the
`
`aortic wall as the evidence of record does not support such a special
`
`meaning.
`
`3. ―means for maintaining‖
`
`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, it is clear, and there is no dispute
`
`among the parties, that the claim phrase is a ―means plus function‖ phrase
`
`interpreted under § 112, sixth paragraph.
`
`―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
`
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`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).
`
`Claim 19 recites a ―means for maintaining said ring member in said
`
`seat about the aortic wall.‖ Petitioner asserts that the ’228 patent describes
`
`the structure for performing the claimed function as ―connecting rods,‖
`
`which anchor valve 100 along the root of the aortic valve. Pet. 10 (citing
`
`Ex. 1001, 5:21-22 and 48-49). Dr. Norred contends that the ―means for
`
`maintaining‖ is the stent system or an equivalent structure. Prelim. Resp. 15
`
`(citing Ex. 1001, 1:29-31, 59-67 and 5:22-25, 48-51).
`
`The ’228 patent discloses four valve designs: figures 6-9 disclose an
`
`umbrella aortic valve; figures 10-13 disclose a cone-shaped aortic valve;
`
`figures 14-17 disclose another version of a cone-shaped valve; and figures
`
`18-19 disclose a cadaver/porcine valve. Ex. 1001, 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
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`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 claim 19. We
`
`therefore adopt this construction for the terms ―means for maintaining‖ for
`
`the purposes of this Decision.
`
`4. ―mean 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.
`
`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. Pet 9-10. Cf.
`
`Prelim. Resp. 15. This proposed construction of the ―means for mounting‖
`
`is reasonable at this stage of the proceeding and we therefore adopt it for the
`
`purposes of this decision.
`
`C. Asserted Grounds of Unpatentability
`
`1. Anticipation of Claims 16-19 by DiMatteo (Ex. 1003)
`
`Medtronic contends that DiMatteo anticipates claims 16-19. Pet. 11-
`
`12 and Appendix A-1. DiMatteo discloses implantable prostheses such as
`
`an aortic valve. Ex. 1003, 1:4-6 and 7:38-41. DiMatteo’s valve includes a
`
`tubular scaffold portion and a leaf valve portion. The scaffold portion of the
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`valve is designed to ―eventually provide fluid-tight engagement with the
`
`body lumen.‖ Id. at 3:29-33. The leaf valve portion includes a valve leaf
`
`frame and valve leaf cover. Id. at 2:27-50. The valve leaf cover may be
`
`made of Dacron, polyethylene (PE), polyethylene terephthalate (PET), silk,
`
`or Rayon. Id.
`
`Figure 1 of DiMatteo is reproduced below.
`
`
`
`Figure 1 shows a prosthetic valve 10 that includes an elongate tubular body
`
`portion 12 and a leaf valve portion 14. Id. at 7:44-61. Leaf valve portion 14
`
`includes valve leafs 40. The scaffold portion includes a tubular open body
`
`scaffold defining a fluid passageway 20 therethrough. Id. The leaf valve
`
`portion 14 is deflectable with respect to body portion 12 about a hinge line
`
`22 between a closed configuration, in which fluid flow through the valve
`
`passageway is restricted, and an open configuration, in which fluid flow
`
`through the valve passageway is permitted. Id.
`
`DiMatteo discloses that the trellis of the value may be mechanically
`
`joined to a collapsible scaffold by a wire. Id. at 13:43-51 and Figure 17.
`
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`11
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`The scaffold portion of the valve is expected to provide fluid-tight
`
`engagement with the body lumen. Id. at 3:29-33. Petitioner relies on this
`
`disclosure in DiMatteo to reach the ―mean for maintaining‖ element of claim
`
`19.
`
`In support of its assertion that DiMatteo anticipates claims 16-19,
`
`Medtronic sets forth the foregoing teachings of DiMatteo and provides a
`
`detailed claim chart explaining how each claim limitation is disclosed in
`
`DiMatteo. Pet. 11–12 and Appendix A-1. Upon review of Medtronic’s
`
`analysis and the evidence of record, we determine that Medtronic has
`
`demonstrated that there is a reasonable likelihood that it would prevail in
`
`showing that DiMatteo anticipates claims 16-19 of the ’228 patent.
`
`Dr. Norred attempts to distinguish the claimed subject matter from
`
`DiMatteo on the basis of the type of seal that is formed. Specifically,
`
`Dr. Norred contends that DiMatteo does not disclose a ring member
`
`designed to seal against the root of the native aortic valve to reduce peri-
`
`valvular leaks. Prelim. Resp. 18. Rather, DiMatteo discloses a liner/trellis
`
`combination designed to eventually form a seal due to tissue ingrowth. Id.
`
`(citing Ex. 1003, 3:29-33 and 4:61-62). We are not persuaded as we do not
`
`read the claims to require a particular type of seal; the claims require a
`
`circumference of a ring member ―to seat about an aortic wall.‖ Ex. 1001,
`
`claim 16.
`
`2. Anticipation of Claims 16-18 by Wolfe (Ex. 1006)
`
`Medtronic contends that Wolfe anticipates claims 16-18. Pet. 15-16
`
`and Appendix A-4. Wolfe relates to center-flow occluders of prosthetic
`
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`heart valve assemblies that can be adapted to replace aortic valves. Ex.
`
`1006, 1:45-51.
`
`Figure 2A of Wolfe is reproduced below.
`
`
`
`Figure 2A shows a heart valve assembly 10 with an occluder 12 disposed for
`
`movement within a valve seat assembly 14. Valve seat assembly 14
`
`includes a soft seating ring 16, a rigid cast supporting ring 18, and a fixation
`
`cover 20. Id. at 3:51-64. Fixation cover 20 may be made of a Dacron mesh
`
`cloth and is initially secured to the heart tissue by suturing. Id. Thrombosis
`
`is then relied upon to retain valve seat assembly 14 in its proper position
`
`within the heart. Id.
`
`Occluder 12 has four plastic cuspids 38 that engage each other in a
`
`closed position and flex outwardly relative to each other in an open position,
`
`thereby defining a central open passage to allow the flow of blood. Id. at
`
`2:1-4 and 3:51-5:11. Occluder 12 is constructed with an armature 54 that
`
`includes an annular ring 56 and a plurality of reinforcing arms extending
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`through each cuspid to permit flexure of each arm relative to the annular
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`ring. Id. at 5:23-45. The reinforcing arms are secured to the ring through
`
`hinge sections. Id.
`
`In support of its assertion that Wolfe anticipates claims 16-18,
`
`Medtronic sets forth the foregoing teachings of Wolfe and provides a
`
`detailed claim chart explaining how each claim limitation is disclosed in
`
`Wolfe. Pet. 15-16 and Appendix A-4. Upon review of Medtronic’s analysis
`
`and the evidence of record, we determine that Medtronic has demonstrated
`
`that there is a reasonable likelihood that it would prevail in showing that
`
`Wolfe anticipates claims 16-18 of the ’228 patent.
`
`Dr. Norred contends that Wolfe discloses a prosthetic heart valve that
`
`must be implanted through traditional open-heart surgery and does not
`
`disclose placement of an aortic valve percutaneously. Prelim. Resp. 24. We
`
`are not persuaded by this argument because the claims are not directed to a
`
`method of implanting a device and do not appear to require a valve capable
`
`of being implanted using any particular method.
`
`Dr. Norred further contends that Wolfe fails to teach a ring member
`
`adapted to seat about an aortic wall surrounding an aortic channel because
`
`the ―ring member‖ identified by Petitioner must be sutured to the artery wall.
`
`Id. at 24-25. We are not persuaded by this argument as we do not read the
`
`claimed language ―to seat about an aortic wall‖ to exclude the use of sutures
`
`to hold the ring member in place.
`
`Dr. Norred further contends that Wolfe does not teach a membrane
`
`movable between a first open position and a second closed position as
`
`claimed. Id. at 25. We are not persuaded by this argument because
`
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`Dr. Norred does not sufficiently explain why Wolfe’s plastic cuspids are not
`
`properly considered ―membranes‖ to a person of ordinary skill in the art.
`
`3. Redundant Grounds
`
`Petitioner also asserts the follow grounds of unpatentability:
`
` (i) Claims 16-18 under 35 U.S.C. § 102(b) over Kischer (Ex. 1004);
`
`and
`
`(ii) Claims 16-19 under 35 U.S.C. § 102(e) over Shaolian (Ex. 1005).
`
`Upon review of those alternative grounds, we conclude that they are
`
`redundant in light of the grounds on the basis of which we institute review.
`
`III. CONCLUSION
`
`We institute an inter partes review of claims 16-19 based on the
`
`following grounds:
`
`(1) Claims 16-19 under 35 U.S.C. § 102(e) over DiMatteo (Ex. 1003);
`
`and
`
`(2) Claims 16-18 under 35 U.S.C. § 102(b) over Wolfe (Ex. 1006).
`
`Petitioner’s remaining grounds are denied as redundant.
`
`IV.
`
` ORDER
`
`For the reasons given, it is
`
`ORDERED that the Petition is granted as to claims 16-19 of the
`
`’228 patent with respect to the following alleged grounds:
`
`1. Claims 16-19 of the ’228 patent under 35 U.S.C. § 102 as
`
`anticipated by DiMatteo; and
`
`2. Claims 16-18 of the ’228 patent under 35 U.S.C. § 102 as
`
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`anticipated by Wolfe.
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`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`
`partes review of the ʼ228 patent is hereby instituted commencing on the
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`entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.
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`§ 42.4, notice is hereby given of the institution of a trial.
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`FURTHER ORDERED that the trial is limited to the grounds listed in
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`the Order. No other grounds are authorized.
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`FURTHER ORDERED that an initial conference call with the Board
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`is scheduled for 11 AM Eastern Time on May 28, 2014. The parties are
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`directed to the Office Trial Practice Guide, 77 Fed. Reg. 48756, 48765-66
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`(Aug. 14, 2012) for guidance in preparing for the initial conference call, and
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`should come prepared to discuss any proposed changes to the Scheduling
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`Order entered herewith and any motions the parties anticipate filing during
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`the trial.
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`16
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`Case IPR2014-00110
`Patent 6,482,228 B1
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`PETITIONER:
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`Jack Barufka
`jack.barufka@pillsburylaw.com
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`Evan Finkel
`evan.finkel@pillsburylaw.com
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`PATENT OWNER:
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`James Kernell
`jjk@kcpatentlaw.com
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`17
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