Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`Paper 46
`Entered: April 23, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC,
`Petitioner,
`
`v.
`
`TROY R. NORRED, M.D.,
`Patent Owner.
`_______________
`
`Case IPR2014-00110
`Patent 6,482,228 B1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, BARRY L. GROSSMAN, and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`Paper 46
`Entered: April 23, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC,
`Petitioner,
`
`v.
`
`TROY R. NORRED, M.D.,
`Patent Owner.
`_______________
`
`Case IPR2014-00110
`Patent 6,482,228 B1
`_______________
`
`
`Before SHERIDAN K. SNEDDEN, BARRY L. GROSSMAN, and
`MITCHELL G. WEATHERLY, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
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`Case IPR2014-00110
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`
`I. INTRODUCTION
`Medtronic, Inc., Medtronic Vascular, Inc., and Medtronic Corevalve,
`LLC (collectively, “Petitioner”) filed a Petition requesting inter partes
`review of claims 1619 (Paper 4, “Pet.”) of US 6,482,228 B1 (Ex. 1001,
`“the ’228 patent”). We instituted trial for the challenged claims on the
`following grounds of unpatentability asserted by Petitioner:
`Reference
`Basis
`Claims Challenged
`DiMatteo1
`§ 102(e) 1619
`Wolfe2
`§ 102(b) 1618
`
`Decision to Institute (Paper 10, “Dec.”), 15.
`After institution, Troy R. Norred, M.D. (“Patent Owner”) filed a
`Patent Owner’s Response (Paper 15, “Resp.”). Petitioner filed a Reply
`(Paper 25, “Reply”).
`Petitioner relies upon the declaration of Alexander J. Hill, Ph.D.
`(Ex. 1018, “Hill Decl.”) in support of its Petition.
`Patent Owner relies upon the declarations of Timothy T. Catchings,
`M.D., (Ex. 2095, “Catchings Decl.”), Troy R. Norred, M.D. (Exhibit 2093,
`“Norred Decl.”), James J. Kernell (Ex. 2094, “Kernell Decl.”), Dr. Stephen
`J. Lombardo (Ex. 2096, “Lombardo Declaration”), and Dr. Carl T. Rutledge
`(Ex. 2097, “Rutledge Decl.”) in support of its Response.
`Patent Owner filed a Motion to Amend Claims (Paper 18, “Mot. to
`Amend”). Petitioner filed an Opposition to Patent Owner’s Motion to
`
`
`1 DiMatteo, US 6,440,164 B1, issued Aug. 27, 2002 (Ex. 1003).
`2 Wolfe, US 4,030,142, issued June 21, 1977 (Ex. 1006).
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`Amend (Paper 26, “Opp.”). Patent Owner filed a Reply in Support of
`Patent Owner’s Motion to Amend (Paper 31, “Amend Reply”).
`Oral argument was conducted on January 27, 2015. A transcript is
`entered as Paper 45 (“Tr.”).
`This Final Written Decision addresses challenges to the patentability
`of claims 1619. Petitioner has shown by a preponderance of the evidence
`that claims 1619 of the ’228 patent are unpatentable.
`Patent Owner’s Motion to Amend Claims is denied.
`
`A. Related Matters
`
`The parties represent that the ’228 patent is the subject of a district
`court case filed February 6, 2013, by Patent Owner against Petitioner in the
`U.S. District Court for the District of Kansas, entitled Troy R. Norred, M.D.
`v. Medtronic, Inc., Case No. 2:13-cv-02061. Pet. 1; Paper 6, 2; Paper 13.
`
`The ’228 patent is the subject of two other inter partes review
`proceedings: IPR2014-00111 and IPR2014-00395.
`
`B. 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, 1:69,
`1:2931. 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.
`Valve 66 consists of interconnected fingers 68, a generally ring-shaped base
`70, and ring 72 secured to base 70. Id. at 4:5464. Base 70 may be seated
`against the root of aortic valve 34. Id. at 5:1719. 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 5:1820. Valve 66 is
`anchored along the root of the aortic valve with connecting rods 80 which
`are connected to stents. Id. at 5:2123.
`
`C. Challenged Claims
`
`Challenged claims 1619 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
`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.
`
`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.
`
`II. ANALYSIS
`
`A. Claim Interpretation
`
`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 the patent in which they appear. 37 C.F.R. § 42.100(b);
`accord In re Cuozzo Speed Techs., LLC, 778 F.3d 1271, 1278–82 (Fed. Cir.
`2015). Claim terms 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 Tech., Inc., 504 F.3d 1249, 1257 (Fed.
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`Cir. 2007). Any special definition for a claim term must be set forth in the
`specification with reasonable clarity, deliberateness, and precision. In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`The “means for mounting” recited in claim 16 is the claim term that
`requires analysis to resolve arguments related to the patentability of the
`challenged claims. 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.
`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 Med.
`Inc., v. Abbott Labs., 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
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`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 Int’l, Inc., 582 F.3d 1288, 1299 (Fed. Cir. 2009).
`Claim 16 recites a:
`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.
`“Means for mounting” is a “means-plus-function” limitation to be construed
`under 35 U.S.C. § 112, sixth paragraph.
`Petitioner contends that, in the conical valve embodiment of Figs.
`1013 of the ’228 patent, the “means for mounting” feature is disclosed as
`fingers 68 hingedly secured together by ring 72 secured to base 70, which
`may be seated against the root of aortic valve 34. Reply 2; Ex. 1001,
`4:545:19. Based on that disclosure, Petitioner proposes that the structure of
`“means for mounting” feature should be construed as “fingers or arms
`hingedly attached or hingedly secured to the ring member and a free end
`spaced therefrom” and equivalents. Id. at 3.
`Patent Owner does not contest Petitioner’s proposed construction of
`the “means for mounting” element recited in claim 16.
`We agree with Petitioner’s analysis and construe the phrase “means
`for mounting” to mean “fingers or arms hingedly attached or hingedly
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`secured to the ring member and a free end spaced therefrom.” In reaching
`that determination, we note that the ’228 patent discloses that the membrane
`is “secured to the inside surfaces 69 of the fingers” (Ex. 1001, 4:5661) or,
`in an alternative embodiment, the membrane is “secured to each arm 84 and
`base 88” (id. at 5:3642). Furthermore, dependent claim 17 recites that the
`structure of the mounting means “comprises at least one arm having a first
`end hingedly secured to said ring member and a free end spaced therefrom.”
`The ’228 patent thus discloses that the membrane is secured or mounted on
`arms or fingers.
`
`B. Priority of Invention
`
`Patent Owner contends that DiMatteo does not anticipate claims
`1619 of the ‘228 Patent because Norred conceived his invention prior to
`DiMatteo, and exercised reasonable diligence in constructively reducing it to
`practice. For the reasons that follow, we are not persuaded that Dr. Norred
`conceived of the invention of the challenged claims prior to the October 21,
`1999 filing date of DiMatteo.
`Conception is “the formation, in the mind of the inventor of a definite
`and permanent idea of the complete and operative invention, as it is
`thereafter to be applied in practice.” Coleman v. Dines, 754 F.2d 353, 359
`(Fed. Cir. 1985) (citing Gunter v. Stream, 573 F.2d 77, 80 (CCPA 1978))
`(emphasis omitted). This requires more than accidental creation; there must
`be evidence that the inventor appreciated that he made “something new.”
`Invitrogen Corp. v. Clontech Labs., Inc., 429 F.3d 1052, 1063–64 (Fed. Cir.
`2005). “The conception analysis necessarily turns on the inventor’s ability
`to describe his invention with particularity. Until he can do so, he cannot
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`prove possession of the complete mental picture of the invention.”
`Burroughs Wellcome Co. v. Barr Labs., Inc., 40 F.3d 1223, 1228 (Fed. Cir.
`1994).
`Proof of conception must be by “corroborating evidence which shows
`that the inventor disclosed to others his ‘completed thought expressed in
`such clear terms as to enable those skilled in the art’ to make the invention.”
`Coleman, 754 F.2d at 359 (citing Field v. Knowles, 183 F.2d 593, 601
`(CCPA 1950)); see also Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577
`(Fed. Cir. 1996) (corroboration requirement “arose out of a concern that
`inventors testifying in patent infringement cases would be tempted to
`remember facts favorable to their case by the lure of protecting their patent
`or defeating another’s patent”). The sufficiency of corroboration is
`determined according to a “rule of reason.” Price v. Symsek, 988 F.2d 1187,
`1195 (Fed. Cir. 1993). This, however, does not dispense with the
`requirement that some independent evidence provide corroboration.
`Coleman, 754 F.2d at 360. The requirement of “independent” corroboration
`requires evidence other than the inventor’s testimony. In re NTP, Inc., 654
`F.3d 1279, 1291–92 (Fed. Cir. 2011).
`In the case at hand, Patent Owner has offered evidence of prior
`invention in the form of Exhibit 2003, which is a sketch that is signed and
`notarized and bears a date of “12/21/98.” Resp. 714. A copy of the
`drawing in Ex. 2003 is reproduced below.
`
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`Patent Owner contends that the sketch contained in Ex. 2003 served as the
`basis for Figures 4 and 18 of the ’228 patent and depicts each limitation set
`forth in claims 16 and 19. Id. (citing Norred Decl. ¶ 8).
`After review of Ex. 2003 and Patent Owner’s arguments related
`thereto, we are not persuaded that the drawing provides sufficient detail to
`establish possession of an embodiment of the invention having the particular
`limitations set forth in the claims. Rather, we agree with Petitioner that the
`sketch 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
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`and sinus;” and (2) a “sutured bioprosthetic valve.” Reply 5. The detail in
`the sketch is insufficient to describe each element of the claims such as, for
`example, a “ring member having a circumference adapted to seat about an
`aortic wall surrounding an aortic channel” (claim 16) or “at least one arm
`having a first end hingedly secured to said ring member and a free end
`spaced therefrom” (claim 17).
`Upon reviewing the record as a whole, however, we cannot conclude
`that the record establishes, by corroborated evidence, that Dr. Norred
`conceived of the invention of the challenged claims prior to the October 21,
`1999 filing date of DiMatteo. Thus, DiMatteo is prior art under 35 U.S.C.
`§ 102(e).
`
`C. Asserted Grounds of Unpatentability
`
`1. Anticipation of Claims 1619 by DiMatteo (Ex. 1003)
`
`a. Summary of DiMatteo (Ex. 1003)
`
`DiMatteo discloses an implantable prosthetic valve having a tubular
`scaffold portion and a leaf valve portion. Ex. 1003, 6:3031. The two body
`portions of the valve are summarized in the following excerpt from
`DiMatteo:
`
`A prosthetic valve . . . [having a] cylindrical radially
`collapsible valve body scaffold defining a fluid passageway
`therethrough for retentive positioning within the lumen. A
`radially collapsible leaf valve member is supported by the
`scaffold includes a number of valve leafs deflectable between a
`closed position restricting fluid flow through the passageway
`and an open position permitting fluid flow through the
`passageway. The leaf valve member includes an interior leaf
`valve frame defining a valve leaf aperture which is sealed by a
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`fluid impermeable nonthrombogenic lining to prevent fluid
`flow therethrough.
`Ex. 1003, Abstract.
`Figure 1 of DiMatteo illustrates an embodiment of the disclosed valve
`and is reproduced below.
`
`
`Figure 1 shows prosthetic valve 10 that includes elongate tubular
`scaffold portion 12 and leaf valve portion 14. Id. at 7:4461. The scaffold
`portion includes a tubular open body defining fluid passageway 20
`therethrough. Id. DiMatteo discloses that the scaffold portion of the valve is
`designed to “eventually provide fluid-tight engagement with the body
`lumen.” Id. at 3:2933.
`Leaf valve portion 14 includes valve leafs 40. Id. at 7:4461. Leaf
`valve portion 14 is deflectable with respect to body portion 12 about 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.
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`The leaf valve portion includes a valve leaf frame and valve leaf
`cover. Id. at 2:2750. The valve leaf cover may be made of Dacron,
`polyethylene (PE), polyethylene terephthalate (PET), silk, or Rayon. Id.
`
`b. Analysis
`
`In its Response, Patent Owner contends that DiMatteo does not
`disclose a ring member as required by independent claim 16. Resp. 3436.
`With regard to this feature of the claim, claim 16 requires “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.”
`Petitioner contends that DiMatteo, summarized above, discloses a ring
`member in the form of tubular body portion 12, which is expected to provide
`fluid-tight engagement with the body lumen. Id. at 3:29–33; Pet. 1112,
`Appendix A-1.
`Patent Owner argues that the recited “ring member” requires a ring
`made of pliable, biocompatible material and argues that DiMatteo does not
`disclose such a ring member. Resp. 3436. Specifically, Patent Owner
`argues that “the purported ring member disclosed in DiMatteo—the liner
`82/trellis 24 combination—is not and cannot be pliable.” Id. at 35. Patent
`Owner further reasons that, because the liner 82/trellis 24 combination is not
`pliable, it cannot be “adapted to seat about an aortic wall” as required by
`claim 16. Id. at 36.
`Petitioner responds with the contention that the ring member in
`DiMatteo is pliable, as the ’228 patent discloses that trellis 24 of tubular
`portion 12 may be formed from shaped memory alloys having superelastic
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`properties. Reply 1213 (citing Ex. 1003, 7:2428, 8:6067, 12:47,
`15:716:2). In this regard, DiMatteo discloses as follows:
`Shaped memory alloys having superelastic properties generally
`made from specific ratios of nickel and titanium, commonly
`known as nitinol, are among the preferred trellis materials.
`Ex. 1003, 8:6467.
`Petitioner contends also that Patent Owner’s expert, Dr. Catchings,
`testified that super elastic material is pliable. Ex. 1009 (Catchings Tr.),
`195:810.
`After review of the evidence and argument summarized above, we are
`persuaded that DiMatteo’s prosthetic valve discloses a ring member having a
`circumference adapted to seat about an aortic wall. DiMatteo’s prosthetic
`valve may be made from superelastic material (Ex. 1003, 8:6467) and is
`expected to sit on an aortic wall (id. at 1:56, 14:5556) and facilitate tissue
`ingrowth for “assimilating the valve of the present invention into the body
`lumen” (id. at 3:2933, 4:6164). We determine that a preponderance of
`evidence supports a finding that the superelastic material of DiMatteo is
`pliable and thus capable of seating about an aortic wall. We are not
`persuaded by Patent Owner’s attempt to distinguish the ring member
`element of the claims from the liner 82/trellis 24 combination used in
`DiMatteo’s device on the basis of pliability. Resp. 3436. Rather, we are
`persuaded by Petitioner’s argument and evidence that DiMatteo discloses an
`aortic valve with a ring member having a circumference adapted to seat
`about an aortic wall surrounding an aortic channel as required by the
`challenged claims.
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`Our Scheduling Order in this case cautioned Patent Owner that “any
`arguments for patentability not raised in the [Patent Owner Response] will
`be deemed waived.” Paper 11, 3. The Board’s Trial Practice Guide,
`furthermore, states that the Patent Owner Response “should identify all the
`involved claims that are believed to be patentable and state the basis for that
`belief.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
`(Aug. 14, 2012) (emphasis added). Furthermore, as the Board has stated,
`our governing statute and Rules “clearly place some onus on the patent
`owner, once trial is instituted, to address the material facts raised by the
`petition as jeopardizing patentability of the challenged claims.” Johnson
`Health Tech Co. Ltd. v. Icon Health & Fitness, Inc., Case IPR2013-00463,
`slip op. 12 (PTAB Jan. 29, 2015) (Paper 41).
`In our Decision to Institute, we concluded that Petitioner had made a
`threshold showing that DiMatteo taught all the limitations of the challenged
`claims, sufficient for us to conclude that there was a reasonable likelihood
`that Petitioner would prevail in showing that the challenged claims were
`anticipated by DiMatteo. Dec. 10–12. We must now determine whether the
`preponderance of the evidence of record supports a finding that DiMatteo
`anticipates the challenged claims. 35 U.S.C. § 316(e).
`In its Response, Patent Owner does not present argument or evidence
`attempting to distinguish any other feature of claims 1619 over the device
`disclosed in DiMatteo. The record now contains the same arguments and
`evidence regarding the merits of DiMatteo’s alleged anticipation with regard
`to the remaining elements of the claims as it did at the time of our Decision
`to Institute. Accordingly, the preponderance of the evidence of record now
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`supports a finding that Petitioner has set forth how these remaining
`limitations of the challenged claims are taught by DiMatteo.
`Based on our review of the record before us, we find by a
`preponderance of the evidence that DiMatteo anticipates claims 16–19.
`
`2. Anticipation of Claims 16–18 by Wolfe (Ex. 1006)
`
`a. Summary of Wolfe (Ex. 1006)
`
`Wolfe relates to center-flow occluders of prosthetic heart valve
`assemblies that can be adapted to replace aortic valves. Ex. 1006, 1:4551.
`Figure 2A of Wolfe is reproduced below.
`
`
`Figure 2A shows heart valve assembly 10 with occluder 12 disposed
`for movement within valve seat assembly 14. Valve seat assembly 14
`includes soft seating ring 16, rigid cast supporting ring 18, and fixation
`cover 20. Id. at 3:5164. Fixation cover 20 may be made of a Dacron mesh
`cloth and is initially secured to the heart tissue by suturing. Id. Thrombosis
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`then is 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
`2:14, 3:515:11. Occluder 12 is constructed with armature 54 that includes
`annular ring 56 and a plurality of reinforcing arms extending through each
`cuspid to permit flexure of each arm relative to the annular ring. Id. at
`5:2345. The reinforcing arms are secured to the ring through hinge
`sections. Id.
`
`b. Analysis
`
`Petitioner contends that Wolfe anticipates claims 1618. Pet. 1516,
`Appendix A-4. Petitioner contends that Wolfe, summarized above, discloses
`a membrane in the form of an occluder 12 having cuspids 38. Id. Cuspids
`38 are configured to move radially to control the flow of blood through the
`valve (Ex. 1006, 1:602:4) and expected to provide fluid-tight engagement
`with the body lumen (id. at 3:2933). Petitioner contends that Wolfe
`discloses the cuspids 38 hingedly connected to annular ring 56 at about
`passageway 32. Pet. at Appendix A-4 (citing Ex. 1006, 5:2745).
`Petitioner identifies valve seat assembly 14 as disclosed in Wolfe
`meeting the ring member element of claim 16. Id. at Appendix A-4 (citing
`Ex. 1006, Figs. 1, 2A, 2B).
`In its Response, Patent Owner contends that Wolfe does not disclose a
`membrane hingedly secured or hingedly attached to “a ring member having
`a circumference adapted to seat about an aortic wall surrounding an aortic
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`channel” as required by independent claim 16. Resp. 3740. Patent Owner
`points out that “[w]hile valve seat assembly 14 may contact the aortic wall
`(though not adapted to seat about it), cuspid 38 is not mounted to valve seat
`assembly 14.” Id. at 38.
`In its Reply, Petitioner responds as follows:
`The limitations of claim 16 are met because, regardless of
`which portion of the ring member the cuspid is mounted to,
`valve seat assembly 14 is “seat[ed] about an aortic wall
`surrounding an aortic channel,” the cuspid’s first open end is
`mounted “about said ring aperture,” and its second end is
`moved “between a first open position … and a second closed
`position” as recited in claim 16.
`
`Reply 1415 (citing Pet. Appendix 1315; Hill Decl. ¶¶ 6164).
`As discussed above, we construe the phrase “means for mounting” to
`mean “fingers or arms hingedly attached or hingedly secured to the ring
`member and a free end spaced therefrom.” After review of the evidence and
`argument summarized above, we agree with Patent Owner’s analysis that
`Wolfe fails to disclose “fingers or arms hingedly attached or hingedly
`secured to the ring member,” where the ring member is “adapted to seat
`about an aortic wall” as recited in claim 16. Rather, Wolfe discloses a heart
`valve assembly having two rings, the valve seat assembly 14 and annular
`ring 56. The valve seat assembly 14 is “adapted to seat about an aortic
`wall.” Pet. 16, Appendix 4. Cuspids 38, however, are not connected to
`valve seat assembly 14. Instead, cuspids 38 are hingedly connected to
`annular ring 56 about passageway 32. Id. Annular ring 56 is not seated
`about the aortic wall, but instead is an element of occluder 12, which is
`movable between closed and opened positions within a seating-ring passage
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`of a valve seat assembly. Ex. 1006, 3:4450, Figs. 2A, 2B. The occluder
`cannot be configured to seat against the aortic wall as required by claim 16,
`because the device of Wolfe requires this portion of the device to be
`movable.
`Based on the record before us, we determine that Wolfe fails to
`disclose a means for mounting a membrane about the aperture of a ring
`member as recited in independent claim 16, which requires the ring member
`to have “a circumference adapted to seat about an aortic wall surrounding an
`aortic channel.” We determine, consequently, that Wolfe fails to anticipate
`the subject matter of claims 1618.
`
`D. Conclusion
`
`Petitioner has shown, by a preponderance of the evidence, that claims
`1619 of the ’228 patent are unpatentable under 35 U.S.C. § 102(e) in view
`of DiMatteo.
`Petitioner has failed to show, by a preponderance of the evidence, that
`claims 1618 of the ’228 patent are unpatentable under 35 U.S.C. § 102(b)
`in view of Wolfe.
`
`III. MOTION FOR OBSERVATION
`Patent Owner’s Motion for Observation pertains to the testimony of
`Alexander J. Hill, Ph.D. on cross-examination. We have considered Patent
`Owner’s observations (Paper 37) and Petitioner’s responses (Paper 39).
`
`IV. MOTION TO AMEND
`Because we have found claims 16–19 to be unpatentable as
`anticipated by DiMatteo, we turn to Patent Owner’s Motion to Amend
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`Claims. In its Motion to Amend, Patent Owner moves to substitute claim 25
`for challenged claim 16. Proposed substitute claim 25 is shown below in
`markup form as compared to the original claim 16 for which it is proposed
`as a substitute.
`25. (Proposed substitute for claim 16) An aortic valve for
`regulating a blood flow through an aortic channel surrounded
`by an aortic wall upon percutaneous placement therein, said
`valve comprising:
`a ring member having a pliable circumference adapted to
`seat about an aortic wall surrounding an aortic channel and seal
`against a root of a native aortic valve upon percutaneous
`placement, said ring member including an aperture for blood
`flow therethrough;
`an expandable stent system extending into the ascending
`aorta upon said percutaneous placement therein and connected
`to said ring member; and
`a membrane having first and second spaced-apart open
`ends, said membrane made of a material resistant to a fluid flow
`therethrough;
`means for mounting said first open end of said membrane
`hingedly secured about said ring aperture of said ring member
`with said second open end displaced therefrom, said means
`moving said membrane second open end movable between a
`first open position to allow a blood flow therethrough and a
`second closed position to preclude blood flow therethrough;
`said aortic valve having a collapsed configuration for
`delivery inside a catheter, and an expanded configuration when
`deployed from said catheter and percutaneously placed in the
`aortic channel.
`Mot. to Amend 1–2.
`Proposed substitute claims may not enlarge the scope of original
`patent claims. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii). In this
`regard, Petitioner argues that proposed claim 25 is broader in scope as
`compared to original challenged claim 16. Opp. 56. Petitioner contends
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`Case IPR2014-00110
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`that the proposed changes eliminate the “means for mounting” language
`from claim 16 and replace it with purely functional language—“membrane
`hingedly secured about said aperture of said ring member”—and eliminates
`the structures that correspond to the original means element—“fingers or
`arms hingedly attached or hingedly secured to the ring member and a free
`end spaced therefrom.” Id.
`Patent Owner responds that the proposed change does not enlarge the
`scope of claim 16 because claim 16 is not limited to embodiments that
`include fingers or arms. Amend Reply 1. Patent Owner argues that the
`membrane attaches directly to the ring aperture and functions as a hinge,
`allowing the valve to move between a closed position and an open position.
`Id. (citing Ex. 2095 ¶ 35). As such, no other structures are necessary to
`perform the required function. Id.
`As discussed above, we construed the phrase “means for mounting” to
`mean “fingers or arms hingedly attached or hingedly secured to the ring
`member and a free end spaced therefrom.” We based this analysis on the
`disclosure in the ’228 patent that describes the membrane “secured to the
`inside surfaces 69 of the fingers” (Ex. 1001, 4:5661) or, in an alternative
`embodiment, “secured to each arm 84 and base 88” (id. at 5:3642).
`Furthermore, dependent claim 17 recites that the structure of the mounting
`means “comprises at least one arm having a first end hingedly secured to
`said ring member and a free end spaced therefrom.” In view of the above
`disclosures in the ’228 patent describing the membrane as secured to fingers
`or arm, we are not persuaded by Patent Owner’s argument that these
`structures are not part of the “mean for mounting” feature of claim 16.
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`Proposed claim 25 replaces the “means for mounting” language of
`claim 16 with a limitation that reads as follows: “said first open end of said
`membrane hingedly secured about said ring aperture of said ring member
`with said second open end displaced therefrom.” This change removes the
`limitation requiring the fingers or arms disclosed in the ’228 patent, which
`are disclosed as structures for which to secure or mount the membrane to the
`ring member. As such, we conclude that the proposed claims impermissibly
`enlarge the scope of the claims, and we deny Patent Owner’s Motion to
`Amend.
`
`V. ORDER
`For the reasons given, it is
`ORDERED that claims 1619 of the ’228 patent are determined to be
`unpatentable;
`FURTHER ORDERED that Petitioner’s Motion to Amend is denied;
`
`and
`
`FURTHER ORDERED that because this is a final written decision,
`parties to the proceeding seeking judicial review of the decision must
`comply with the notice and service requirements of 37 C.F.R. § 90.2.
`
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`Case IPR2014-
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