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
`______________________
`
`PATENT OWNER REPLY IN SUPPORT OF MOTION TO AMEND
`PURSUANT TO 37 C.F.R. § 42.121
`
`
`
`
`
`
`
`
`______________________
`
`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
`______________________
`
`PATENT OWNER REPLY IN SUPPORT OF MOTION TO AMEND
`PURSUANT TO 37 C.F.R. § 42.121
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`
`
`
`II.
`
`III. Norred Provided Support For The Substitute Claim
`
`IV. Norred Showed The Substitute Claim Was Patentable
`
`
`
`ii
`
`
`
`TABLE OF CONTENTS
`
`The Amendments Do Not Enlarge The Scope Of The Claims
`And Are Responsive To A Ground Of Unpatentability
`
`Claim Constructions Are Not Needed For New Terms
`
` 1
`
` 2
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` 3
`
` 3
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`
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`
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`
`567 F.3d 1314 (Fed. Cir. 1009)
`
`KSR Int’l Co. v. Teleflex,
`
`127 S.Ct. 1727 (2007)
`
`
`
` 4
`
` 3
`
` iii
`
`
`
`I.
`
`The Amendments Do Not Enlarge The Scope Of The
`Claims And Are Responsive To A Ground Of Unpatentability
`The proposed amendments substitute independent Claim 25 for independent
`
`Claims 16 and 20. Claim 16 is eliminated in its entirety. The language of Claim 20 is
`
`carried forward in Claim 25 with modifications that narrow the claim. In place of the
`
`means-plus-function limitation of Claim 20—“means for maintaining said ring
`
`member in said seated position about the aortic wall”—Claim 25 specifies the ring
`
`member is “anchor[ed] … in said seated position against the aortic wall” by “a stent
`
`system having a plurality of interconnected rods.” This is consistent with the Board’s
`
`interpretation of the original claim language. The Board held “the combination of
`
`rods 104 interacting with stent 28 … is the structure comprising the means for
`
`maintaining called for in claims 19-20.” Paper 13 at 13. Dependent claim 26 is added
`
`to require that the stent system extend into the ascending aorta, as described in the
`
`specification. (Ex. 1001, 2:67, 3:8, Figs. 4 & 5.)
`
`Petitioner argues the proposed amendments broaden Claim 16 by eliminating
`
`the “means for mounting” language in that claim. Paper 25 at 6-7. This argument is
`
`misplaced. Claim 16 is eliminated in its entirety. None of the language of the claim is
`
`carried forward in the proposed amendments.
`
`Petitioner argues the proposed amendments broaden Claim 20 by eliminating
`
`interconnected rods 104 from the claim. Paper 25 at 7. This is not true. Claim 25
`
`makes specific reference to “a plurality of interconnected rods,” and requires that the
`
`
`
`1
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`
`
`
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`ring member be connected to “one or more of said plurality of interconnected rods.”
`
`Petitioner argues that in original Claim 20, rods 104 are “part of the valve” and
`
`“separate and distinct from stent 28.” Paper 25 at 6. Yet, Fig. 18—where rods 104
`
`are shown—is described as depicting the “valve and stent system.” (Ex. 1001, 2:48.)
`
`Moreover, Dr. Timothy Catchings testified on cross-examination that rods 104 “form
`
`the distal part of the stent itself.” (Ex. 1001, Fig. 18; Ex. 1023, 129:11-130:22.)
`
`II. Claim Constructions Are Not Needed For New Terms
`The terms in Claim 25 should be given their ordinary and customary meanings,
`
`consistent with the Specification, as those terms would be understood by one with
`
`ordinary skill in the art. Special claim constructions are not required because the
`
`terms are not subject to dispute. Drs. Catchings and Norred do not disagree about
`
`the meaning of the term “pliable.” Dr. Catchings testified that a superelastic stent [as
`
`described in DiMatteo] is a stent that is “easily malleable … [and] can be twisted,
`
`turned, moved into shape easily without permanent deformity.” (Ex. 1023, 181:10-
`
`15.) Dr. Norred did not contest this point. (Ex. 1024, 84:5-85:5.) Instead, he stated
`
`that once deployed, the DiMatteo stent must maintain a perfectly circular shape. See
`
`IPR2014-00110, Paper 15 (Response) at 35-36. This means it must be rigid. Id.
`
`Otherwise, it will conform to the irregular shape of the aortic wall and the valve
`
`leaflets will misalign. Id. (See also Ex. 1023, 247:11-248:12; Ex. 2332 (illustration).)
`
`Petitioner’s own witness, Alexander Hill, agreed this could occur. (Ex. 2353, 188:14-
`
`192:13; Ex. 2332.)
`
` 2
`
`
`
`
`
`III. Norred Provided Support For The Substitute Claim
`The ‘228 patent is not limited to prosthetic valves incorporating balloon-
`
`expandable stents. While the specification discusses the use of a balloon to place the
`
`valve prosthesis (Ex. 1001, 2:61-3:12), this merely is a method of placement. It is not
`
`a description of the device being placed. The device being placed is described as a
`
`“stent system made up of a small slotted stainless tube or series of interconnected
`
`rods which form an expandable lattice or scaffolding” (Ex. 1001, 2:61-63). Both
`
`balloon-expandable and self-expanding stents can be constructed in such a manner
`
`(see generally Ex. 1022, 1:59-6:21). Furthermore, balloons must be used with self-
`
`expanding stents where excessive calcification or incomplete expansion prevents the
`
`prosthesis from sealing correctly. (See, e.g., Ex. 2345 at p. 3.)
`
`The stent system is incorporated into Claims 19 and 20 through the means-
`
`plus-function language. The combination of rods 104 interacting with stent 28 is the
`
`structure that maintains the ring member against the aortic wall. Paper 13 at 9. This
`
`is what makes the valve prosthesis operable and is an integral part of Norred’s
`
`invention. (See Ex. 1001, Abstract, 1:6-10, 29-31, 2:62-63, 3:1-45, Figs. 1-5.)
`
`IV. Norred Showed The Substitute Claim Was Patentable
`In examining whether a claimed invention is obvious, a threshold issue is
`
`whether the elements of the invention are found in prior art. See KSR Int’l Co. v.
`
`Teleflex, 127 S. Ct. 1727, 1739-42 (2007) (citations omitted). None of the 33 prior art
`
`references that Norred examined as part of his Motion to Amend incorporate the
`
` 3
`
`
`
`
`
`stent and ring member described in Claims 25 and 26.
`
`One of the references cited by Petitioner—Schreck—incorporates a stent that
`
`is confined to the native annulus, and therefore cannot displace aortic pressure in a
`
`manner mimicking the native valve. (Ex. 2299, 5:37-51, 8:49-51, Fig. 16C; Ex. 2353,
`
`164:15-22.) Because of its design (it is fully surrounded by fabric), the stent cannot
`
`extend into the ascending aorta as required by Claim 26 without blocking the
`
`coronary arteries. (See Ex. 2299, 6:46-49, 9:11-13, Fig. 6; Ex. 2342 at 11-13, Fig. 2.9.)
`
`Further, Petitioner’s witness acknowledged that if the stent were placed in the
`
`ascending aorta instead of in the native annulus, the valve would occlude the coronary
`
`arteries when it closed. (Ex. 2353, 163:1-164:14.)
`
`Figulla includes a stent that extends into the ascending aorta, but relies on
`
`barbs to anchor it against the aortic wall. (Ex. 1008 at 9.) Fraunhofer also relies on
`
`barbs. (Ex. 2327 at 3:41-4:5.) This would not be acceptable to a person of ordinary
`
`skill in the art. (Ex. 2295, ¶ 48; Ex. 2293, ¶ 73.) As Dr. Catchings explained,
`
`“[e]xpansion of the stent will cause these sharp areas of protrusion to come into
`
`contact with delicate surrounding tissue. … [This] could lead to aortic dissection
`
`and/or perforation.” (Ex. 2295, ¶ 48.)
`
`Petitioner downplays the significance of barbs, arguing they are not excluded
`
`by the proposed amendments or the specification. Paper 25 at 13. But the ‘228
`
`Patent describes a prosthetic valve anchored in place by the stent alone. (Ex. 1001,
`
`1:29-31, 3:1-13, Fig. 5.) Figulla and Faunhofer teach away from the ‘228 Patent by
`
` 4
`
`
`
`
`
`suggesting separate structures are needed to affix the prosthesis to the aortic wall.
`
`(Ex. 1008 at 9-10, 11; Ex. 2327 at 3:41-4:5.) It would not have been obvious from
`
`Figulla or Fraunhofer that an operable prosthesis could be designed that omits these
`
`structures. See DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326
`
`(Fed. Cir. 1009) (combination not obvious where prior art teaches away from
`
`invention).
`
`Certain prior art references include ring-like structures, but they are not pliable
`
`(see e.g., Ex. 2316 and 2317), do not seal (see e.g., Exs. 1008 and 1009), or do not seal
`
`upon percutaneous placement (see e.g., Exs. 1010, 2302, 2303 and 2304). Petitioner
`
`makes much of the fact that Figulla provides for a “tight fit” against the aortic wall,
`
`and Fraunhofer provides for a “secure hold” in the aorta. Paper 25 at 11-12. But the
`
`purported ring members in Figulla and Fraunhofer are merely portions of the stent,
`
`and cannot—by themselves—create the seal required by Claim 25. (See Ex. 2195, ¶
`
`41.) The purported ring member in Schreck is a separate structure, but it is attached
`
`to a plurality of upstanding posts distributed evenly around the periphery of the tubular
`
`base rather than a plurality of interconnected rods as required by Claim 25. (Ex. 2299,
`
`6:39-41.)
`
`Respectfully Submitted,
`
`
`
`
`
`ERICKSON KERNELL DERUSSEAU & KLEYPAS, LLC
`
`
` /s/ James J. Kernell
`James J. Kernell, Reg. No. 42720
`Telephone: (913) 549-4700 Facsimile: (913) 549-4646
`
` 5
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`CERTIFICATE OF SERVICE
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`I hereby certify this 11th day December 2014, that the foregoing Patent Owner
`
`
`
`
`
`Reply In Support Of Motion To Amend Pursuant To 37 C.F.R. § 42.121 has been
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`served electronically through the Patent Trial and Appeals Board’s Patent Review
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`Processing System (PRPS) upon the lead and back-up counsel for the Petitioner,
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`JACK BARUFKA and EVAN FINKEL, both of Pillsbury Winthrop Shaw Pittman
`
`LLP.
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`/s/ James J. Kernell
`
`Attorney for Patent Owner
`
`
`
` 6
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