`______________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
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`MEDTRONIC, INC., MEDTRONIC VASCULAR, INC.,
`and MEDTRONIC COREVALVE, LLC
`Petitioner
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`v.
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`TROY R. NORRED, M.D.
`Patent Owner
`______________________
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`Case IPR2014-00395
`Patent 6,482,228
`______________________
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`PATENT OWNER REPLY IN SUPPORT OF MOTION TO AMEND
`PURSUANT TO 37 C.F.R. § 42.121
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`I.
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`II.
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`III. Norred Provided Support For The Substitute Claim
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`IV. Norred Showed The Substitute Claim Was Patentable
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`ii
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`TABLE OF CONTENTS
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`The Amendments Do Not Enlarge The Scope Of The Claims
`And Are Responsive To A Ground Of Unpatentability
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`Claim Constructions Are Not Needed For New Terms
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`TABLE OF AUTHORITIES
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`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
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`567 F.3d 1314 (Fed. Cir. 1009)
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`KSR Int’l Co. v. Teleflex,
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`127 S.Ct. 1727 (2007)
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` iii
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`I.
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`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
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`Claims 16 and 20. Claim 16 is eliminated in its entirety. The language of Claim 20 is
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`carried forward in Claim 25 with modifications that narrow the claim. In place of the
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`means-plus-function limitation of Claim 20—“means for maintaining said ring
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`member in said seated position about the aortic wall”—Claim 25 specifies the ring
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`member is “anchor[ed] … in said seated position against the aortic wall” by “a stent
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`system having a plurality of interconnected rods.” This is consistent with the Board’s
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`interpretation of the original claim language. The Board held “the combination of
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`rods 104 interacting with stent 28 … is the structure comprising the means for
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`maintaining called for in claims 19-20.” Paper 13 at 13. Dependent claim 26 is added
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`to require that the stent system extend into the ascending aorta, as described in the
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`specification. (Ex. 1001, 2:67, 3:8, Figs. 4 & 5.)
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`Petitioner argues the proposed amendments broaden Claim 16 by eliminating
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`the “means for mounting” language in that claim. Paper 25 at 6-7. This argument is
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`misplaced. Claim 16 is eliminated in its entirety. None of the language of the claim is
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`carried forward in the proposed amendments.
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`Petitioner argues the proposed amendments broaden Claim 20 by eliminating
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`interconnected rods 104 from the claim. Paper 25 at 7. This is not true. Claim 25
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`makes specific reference to “a plurality of interconnected rods,” and requires that the
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`ring member be connected to “one or more of said plurality of interconnected rods.”
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`Petitioner argues that in original Claim 20, rods 104 are “part of the valve” and
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`“separate and distinct from stent 28.” Paper 25 at 6. Yet, Fig. 18—where rods 104
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`are shown—is described as depicting the “valve and stent system.” (Ex. 1001, 2:48.)
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`Moreover, Dr. Timothy Catchings testified on cross-examination that rods 104 “form
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`the distal part of the stent itself.” (Ex. 1001, Fig. 18; Ex. 1023, 129:11-130:22.)
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`II. Claim Constructions Are Not Needed For New Terms
`The terms in Claim 25 should be given their ordinary and customary meanings,
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`consistent with the Specification, as those terms would be understood by one with
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`ordinary skill in the art. Special claim constructions are not required because the
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`terms are not subject to dispute. Drs. Catchings and Norred do not disagree about
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`the meaning of the term “pliable.” Dr. Catchings testified that a superelastic stent [as
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`described in DiMatteo] is a stent that is “easily malleable … [and] can be twisted,
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`turned, moved into shape easily without permanent deformity.” (Ex. 1023, 181:10-
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`15.) Dr. Norred did not contest this point. (Ex. 1024, 84:5-85:5.) Instead, he stated
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`that once deployed, the DiMatteo stent must maintain a perfectly circular shape. See
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`IPR2014-00110, Paper 15 (Response) at 35-36. This means it must be rigid. Id.
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`Otherwise, it will conform to the irregular shape of the aortic wall and the valve
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`leaflets will misalign. Id. (See also Ex. 1023, 247:11-248:12; Ex. 2332 (illustration).)
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`Petitioner’s own witness, Alexander Hill, agreed this could occur. (Ex. 2353, 188:14-
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`192:13; Ex. 2332.)
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`III. Norred Provided Support For The Substitute Claim
`The ‘228 patent is not limited to prosthetic valves incorporating balloon-
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`expandable stents. While the specification discusses the use of a balloon to place the
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`valve prosthesis (Ex. 1001, 2:61-3:12), this merely is a method of placement. It is not
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`a description of the device being placed. The device being placed is described as a
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`“stent system made up of a small slotted stainless tube or series of interconnected
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`rods which form an expandable lattice or scaffolding” (Ex. 1001, 2:61-63). Both
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`balloon-expandable and self-expanding stents can be constructed in such a manner
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`(see generally Ex. 1022, 1:59-6:21). Furthermore, balloons must be used with self-
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`expanding stents where excessive calcification or incomplete expansion prevents the
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`prosthesis from sealing correctly. (See, e.g., Ex. 2345 at p. 3.)
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`The stent system is incorporated into Claims 19 and 20 through the means-
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`plus-function language. The combination of rods 104 interacting with stent 28 is the
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`structure that maintains the ring member against the aortic wall. Paper 13 at 9. This
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`is what makes the valve prosthesis operable and is an integral part of Norred’s
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`invention. (See Ex. 1001, Abstract, 1:6-10, 29-31, 2:62-63, 3:1-45, Figs. 1-5.)
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`IV. Norred Showed The Substitute Claim Was Patentable
`In examining whether a claimed invention is obvious, a threshold issue is
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`whether the elements of the invention are found in prior art. See KSR Int’l Co. v.
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`Teleflex, 127 S. Ct. 1727, 1739-42 (2007) (citations omitted). None of the 33 prior art
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`references that Norred examined as part of his Motion to Amend incorporate the
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`stent and ring member described in Claims 25 and 26.
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`One of the references cited by Petitioner—Schreck—incorporates a stent that
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`is confined to the native annulus, and therefore cannot displace aortic pressure in a
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`manner mimicking the native valve. (Ex. 2299, 5:37-51, 8:49-51, Fig. 16C; Ex. 2353,
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`164:15-22.) Because of its design (it is fully surrounded by fabric), the stent cannot
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`extend into the ascending aorta as required by Claim 26 without blocking the
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`coronary arteries. (See Ex. 2299, 6:46-49, 9:11-13, Fig. 6; Ex. 2342 at 11-13, Fig. 2.9.)
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`Further, Petitioner’s witness acknowledged that if the stent were placed in the
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`ascending aorta instead of in the native annulus, the valve would occlude the coronary
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`arteries when it closed. (Ex. 2353, 163:1-164:14.)
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`Figulla includes a stent that extends into the ascending aorta, but relies on
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`barbs to anchor it against the aortic wall. (Ex. 1008 at 9.) Fraunhofer also relies on
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`barbs. (Ex. 2327 at 3:41-4:5.) This would not be acceptable to a person of ordinary
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`skill in the art. (Ex. 2295, ¶ 48; Ex. 2293, ¶ 73.) As Dr. Catchings explained,
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`“[e]xpansion of the stent will cause these sharp areas of protrusion to come into
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`contact with delicate surrounding tissue. … [This] could lead to aortic dissection
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`and/or perforation.” (Ex. 2295, ¶ 48.)
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`Petitioner downplays the significance of barbs, arguing they are not excluded
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`by the proposed amendments or the specification. Paper 25 at 13. But the ‘228
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`Patent describes a prosthetic valve anchored in place by the stent alone. (Ex. 1001,
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`1:29-31, 3:1-13, Fig. 5.) Figulla and Faunhofer teach away from the ‘228 Patent by
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`suggesting separate structures are needed to affix the prosthesis to the aortic wall.
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`(Ex. 1008 at 9-10, 11; Ex. 2327 at 3:41-4:5.) It would not have been obvious from
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`Figulla or Fraunhofer that an operable prosthesis could be designed that omits these
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`structures. See DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326
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`(Fed. Cir. 1009) (combination not obvious where prior art teaches away from
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`invention).
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`Certain prior art references include ring-like structures, but they are not pliable
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`(see e.g., Ex. 2316 and 2317), do not seal (see e.g., Exs. 1008 and 1009), or do not seal
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`upon percutaneous placement (see e.g., Exs. 1010, 2302, 2303 and 2304). Petitioner
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`makes much of the fact that Figulla provides for a “tight fit” against the aortic wall,
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`and Fraunhofer provides for a “secure hold” in the aorta. Paper 25 at 11-12. But the
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`purported ring members in Figulla and Fraunhofer are merely portions of the stent,
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`and cannot—by themselves—create the seal required by Claim 25. (See Ex. 2195, ¶
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`41.) The purported ring member in Schreck is a separate structure, but it is attached
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`to a plurality of upstanding posts distributed evenly around the periphery of the tubular
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`base rather than a plurality of interconnected rods as required by Claim 25. (Ex. 2299,
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`6:39-41.)
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`Respectfully Submitted,
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`ERICKSON KERNELL DERUSSEAU & KLEYPAS, LLC
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` /s/ James J. Kernell
`James J. Kernell, Reg. No. 42720
`Telephone: (913) 549-4700 Facsimile: (913) 549-4646
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`CERTIFICATE OF SERVICE
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`I hereby certify this 11th day December 2014, that the foregoing Patent Owner
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`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
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`LLP.
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`/s/ James J. Kernell
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`Attorney for Patent Owner
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