UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
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`MEDTRONIC, INC., and MEDTRONIC VASCULAR, INC.
`Petitioner
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`v.
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`MARITAL DEDUCTION TRUST
`Patent Owner
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`____________
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`Case IPR2014-00100
`Patent 5,593,417
`____________
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`Attorney Docket No. 058888-0000015
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`____________
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`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
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`404793467v1
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`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MEDTRONIC, INC., and MEDTRONIC VASCULAR, INC.
`Petitioner
`
`v.
`
`MARITAL DEDUCTION TRUST
`Patent Owner
`
`____________
`
`Case IPR2014-00100
`Patent 5,593,417
`____________
`
`Attorney Docket No. 058888-0000015
`
`____________
`
`PETITIONER’S REPLY TO PATENT OWNER’S RESPONSE
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`404793467v1
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`I.
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`II.
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`TABLE OF CONTENTS
`A FINDING THAT INDEPENDENT CLAIM 1 IS UNPATENTABLE
`IS DISPOSITIVE OF DEPENDENT CLAIMS 2, 9, 10, AND 13 ................. 1
`THE CLAIMS ARE ANTICIPATED BY KORNBERG ............................... 1
`A. Kornberg Satisfies All the Structural Requirements of the Claims ........... 1
`B. The “Whereupon Clause” Is Not A Limitation .......................................... 1
`C. If the Whereupon Clause is a Limitation, it is Met by Kornberg ............... 3
`1. Patent Owner’s Expert Testified The Plain and Ordinary Meaning
`of “Tightly Engage” is “Very Securely Attach” ................................... 3
`2. Patent Owner’s Expert Also Offered a Much Narrower Construction
`of “Tightly Engage” .............................................................................. 4
`3. Kornberg Meets The Whereupon Clause Under Either Construction
`of “Tightly Engage” .............................................................................. 7
`III. THE CLAIMS ARE OBVIOUS OVER THE ‘154 PATENT IN VIEW
`OF KORNBERG ........................................................................................... 10
`A. The ‘154 Patent Discloses the Same Device as the ‘417 Patent Except
`for the Expressly Claimed Angle of the Projections ................................ 10
`B. There Are No Secondary Indicia of Non-Obviousness ............................ 13
`IV. CONCLUSION .............................................................................................. 15
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`TABLE OF REFERENCED EXHIBITS AND OTHER DOCUMENTS
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`
`Abbreviation Exhibit Description
`Resp.
`-
`Patent Owner Response
`‘417
`1001
`U.S. Patent No. 5,593,417 to Rhodes
`Kornberg
`1006
`U.S. Patent No. 4,562,596 to Kornberg
`‘154
`1008
`U.S. Patent No. 5,122,154 to Rhodes
`Chuter
`2009
`U.S. Patent No. 5,387,235 to Chuter
`Lazarus
`2010
`U.S. Patent No. 5,397,345 to Lazarus
`Tessman
`2004
`U.S. Patent No. 5,167,614 to Tessman
`Rowe Decl.
`1003
`Declaration of Travis Rowe
`Gupta Decl.
`1004
`Declaration of Atul Gupta
`Silver Decl.
`2002
`Declaration of James Silver, Ph.D.
`Rowe Tr.
`2023
`Transcript of Deposition of Travis Rowe
`Gupta Tr.
`2021
`Transcript of Deposition of Atul Gupta
`Silver Tr.
`1014
`Transcript of Deposition of James Silver
`-
`1018
`Ex. 4 to the Deposition of James Silver (Drawing)
`-
`1019
`Ex. 5 to the Deposition of James Silver (Drawing)
`-
`1020
`Ex. 6 to the Deposition of James Silver (Drawing)
`-
`1021
`Ex. 7 to the Deposition of James Silver (Drawing)
`-
`1022
`Ex. 8 to the Deposition of James Silver (Drawing)
`-
`1023
`Ex. 9 to the Deposition of James Silver (Drawing)
`-
`1024
`Ex. 10 to the Deposition of James Silver (Drawing)
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`I.
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`A FINDING THAT INDEPENDENT CLAIM 1 IS UNPATENTABLE
`IS DISPOSITIVE OF DEPENDENT CLAIMS 2, 9, 10, AND 13
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`The Patent Owner argues that independent claim 1 is patentable, but does
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`not separately address the dependent claims. See Resp. at 39 and 42 (arguing
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`“dependent claims 2, 9, 10 or 13” are patentable only because they “include all of
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`the limitations of claim 1”). It therefore is not necessary to separately consider the
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`patentability of the dependent claims. See, e.g., Garmin International, Inc. v.
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`Cuozzo Speed Technologies, LLC, IPR2012-00001 (Paper 59 at 47, Nov. 13, 2013).
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`II. THE CLAIMS ARE ANTICIPATED BY KORNBERG
`A. Kornberg Satisfies All the Structural Requirements of the Claims
`Claim 1, directed to “[a]n intraluminal medical device,” recites structural
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`elements followed by a “whereupon clause.” The Patent Owner does not argue
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`that Kornberg fails to disclose any structural elements of claim 1, and instead
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`focuses exclusively on the whereupon clause. See Resp. at 31 (“Kornberg does not
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`anticipate those claims because it fails to teach or suggest the [whereupon clause]”).
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`See also Resp. §§IV.A, B and C and Silver Decl., ¶¶62, 69, 70, 76 (same
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`arguments). Thus, if the whereupon clause is not a limitation (see §II.B below), or
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`it is a limitation which is met by Kornberg (see §II.C below), the claims are
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`anticipated by Kornberg.
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`The “Whereupon Clause” Is Not A Limitation
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`B.
`The whereupon clause in claim 1 should not be given any patentable weight
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`because it simply expresses the intended result of the structural limitations recited
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`in the claim. MPEP 2111.04; Lockheed Martin Corp. v. Space Systems/Loral, Inc.,
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`324 F.3d 1308, 1319 (Fed. Cir. 2003) (no consideration given to whereby clause in
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`claim to a satellite control system “because a whereby clause that merely states the
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`result of the limitations in the claim adds nothing to the substance of the claim”).
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`Claim 1 recites the structural details of the “anchoring means” of the
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`claimed “intraluminal medical device” as a plurality of projections that includes a
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`leading portion located in the upstream direction of the fluid flow, and a trailing
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`portion located in the downstream direction of blood flow that is “oriented to
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`extend at an acute angle” to the direction of blood flow. ‘417, claim 1.
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`The whereupon clause that immediately follows expresses the intended
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`result of a device having such projections, namely, to allow fluid force to cause the
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`projections to “tightly engage” with the vessel’s interior surface “to fixedly secure
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`the device in place.” Id. This is consistent with the patent’s specification which
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`follows a description of the structure of the projections with statements that it “will
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`be appreciated by those skilled in the art” that the force applied to the projections
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`by the blood flow through the device “will tend to force the projections 40 into
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`good engagement with the wall 12 of the vessel, duct, or lumen.” Id., 8:1-21.
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`Because the whereupon clause simply expresses the intended result of the
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`structural limitations in the claim, it should not be given any patentable weight.
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`See, e.g., Titan Atlas Mfg. Inc. v. Sisk, 894 F.Supp.2d 754, 763 (W.D. Va. 2012)
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`(whereby clause stating claimed mine ventilation structure “forms an air seal” is
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`not a limitation and would not be construed).
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`C.
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`If the Whereupon Clause is a Limitation, it is Met by Kornberg
`1.
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`Patent Owner’s Expert Testified The Plain and Ordinary
`Meaning of “Tightly Engage” is “Very Securely Attach”
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`“The Patent Owner submits that the terms with the root ‘engage’ –
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`‘engagement with or ‘engaging’ – require no construction, and the plain and
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`ordinary meaning should apply.” Resp. at 26. In his deposition, the Patent
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`Owner’s expert, Dr. Silver, testified that to “a person of ordinary skill in the art,”
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`the “ordinary or customary meaning” of the term “tightly engage” means that the
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`device “was very securely attached to the vessel wall, and … even more unlikely to
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`move” than if the device was only engaged. Silver Tr., 22:15-20; see also Silver
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`Tr., 21:12-22:12 (“ordinary and customary meaning” of the term “tightly engaged”
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`“to a person of ordinary skill in the art” means “it’s secured to the wall probably of
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`a blood vessel in such a way that it’s unlikely to become dislodged.”).
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`While Dr. Silver commented that a person of ordinary skill in the art might
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`expect to use the terms “penetration or perforation” instead of “tightly engage” if
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`the projection “were to penetrate the entire vessel wall” (id. at 25:8-26:3), he then
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`admitted that where the projection penetrates or perforates the entire vessel wall,
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`“it may be tightly engaged, but it’s also beyond that” (id. at 26:4-7).
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`Thus, using Dr. Silver’s testimony, the “broadest reasonable construction [of
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`“tightly engage”] in light of the specification” (37 C.F.R. § 42.100(b)) is to “very
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`securely attach,” and does not exclude penetrating/puncturing the vessel wall.
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`2.
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`Patent Owner’s Expert Also Offered a Much Narrower
`Construction of “Tightly Engage”
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`At his deposition, Dr. Silver argued for a narrow interpretation of the terms
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`“engage” and “tightly engage,” with reference to drawings he prepared. Ex. 1018-
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`1024. According to Dr. Silver: (i) upon deployment of the device, the projections
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`touch (“engage”) the vessel’s interior surface but do not penetrate into the intimal
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`(innermost) layer (Silver Tr.,23:18-24:3; 34:13-19 and Ex. 1018; 40:21-25 and Ex.
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`1020; 54:25-55:9; 58:25-59:7); and (ii) after deployment, blood flow causes the
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`projections to penetrate into the intimal layer (“tightly engage”) but not through the
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`intimal layer to the medial (middle) layer or the adventitial (outermost) layer or
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`beyond (Silver Tr., 23:18-24:3; 36:19-37:9, and Ex. 1018; 41:2-11, 42:2-43:8, and
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`Ex. 1020; 54:25-55:9; 58:25-59:7; 99:17-100:11 and Ex. 1023; Resp. at 29).
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`Dr. Silver’s proposed narrow construction of the term “tightly engage” is
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`inconsistent with his testimony regarding the plain and ordinary meaning of the
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`term “tightly engage,” and more appropriate for consideration in litigation where
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`the claim construction standards are quite different. The proposed narrow
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`construction is problematic for a multitude of other reasons as well.
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`Dr. Silver’s contention that the term “tightly engage” excludes penetration of
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`the projections into the intimal layer upon deployment, contradicts his declaration
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`in which he stated “[i]t is not my opinion that claim 1 entirely precludes …
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`penetration of the anchors upon deployment.” Silver Decl. at 39, fn. 1.
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`Dr. Silver also failed to reconcile his contention that after deployment the
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`projections penetrate into the intimal layer but not through the intimal layer, with
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`the ‘417 patent’s recognition that the claimed device poses a risk of the projections
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`puncturing through the wall of vessel. See ‘417, 3:55-57; see also Silver Tr., 51:7-
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`52:7 (conceding the ‘417 device poses some risk of puncturing the vessel wall).
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`Dr. Silver’s contentions are also problematic given the ‘417 patent’s lack of
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`any disclosure as to how to design a device that upon deployment would touch the
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`vessels’ interior surface without penetrating into the intimal layer, and that would
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`not penetrate through the intimal layer, which is only 10 cells or 0.2 mm deep
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`(Silver Tr., 34:21-24, 92:22-93:4), as a result of blood flow forces. All the ‘417
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`patent says is that the projection has a height of between 1.0 and 1.5 mm (‘417,
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`8:31-35) and is “preferentially oriented” at an “acute angle to the direction of blood
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`flow” (‘417, 4:10-13, 7:17-22, 8:7-11, 8:64-67, 9:6-8). See Silver Tr., 46:9-49:3
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`(failing to identify any disclosure other than the height and acute angle references).
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`The proposed construction would also raise indefiniteness concerns. It is not
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`“possible to control the depth of penetration of the anchors with perfect specificity
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`due to a number of variables” (Resp. at 12; see also Silver Decl., ¶46) including
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`the sharpness of the projections; radial force outwardly exerted by a balloon or a
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`self-expanding stent; manual force applied by a practitioner; the magnitude of the
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`blood flow force; diameter of the vessel; thickness and hardness of the plaque
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`buildup in the vessel; curvature of the vessel; the pulsatile expansion and
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`contraction of the vessel; and elasticity of the vessel. Silver Tr., 61:13-63:1, 96:15-
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`21; Resp. at 12; Silver Decl., ¶46; see also Rowe Tr., 25:4-19; Gupta Tr., 48:1-6.
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`Thus, Dr. Silver conceded that under his construction, the same exact device,
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`when used in a patient may or may not satisfy the claim limitations depending on
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`these variables. Silver Tr., 227:10-233:16. A fortiori, even though the claims are
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`drawn to “an intraluminal medical device,” it is impossible to determine whether a
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`device that is made and sold is within the scope of the claim because that depends
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`on how the device is actually used in the future by a medical practitioner.
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`The claims would therefore be subject to challenge for indefiniteness under
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`Dr. Silver’s proposed narrow construction. See Nautilus, Inc. v. Biosig Instruments,
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`Inc., 134 S. Ct. 2120, 2124 (2014) (claim invalid for indefiniteness if it “fail[s] to
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`inform, with reasonable certainty, those skilled in the art about the scope of the
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`invention.”); see also Honeywell Int'l, Inc. v. Int'l Trade Comm'n, 341 F.3d 1332,
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`1338-41 (Fed. Cir. 2003) (claim indefinite because whether limitation met depends
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`on method used for determining melting point elevation but specification was
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`silent on which of the available methods were to be used).
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`3. Kornberg Meets The Whereupon Clause Under Either
`Construction of “Tightly Engage”
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`The Patent Owner argues that Kornberg does not meet the whereupon clause
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`for two reasons, neither of which has any merit. Resp. at 31. One reason given is
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`that “tightly engage” excludes a projection which punctures the artery wall and the
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`Kornberg hooks (projections) puncture the artery wall. Resp. §IV.C. at 36-39; see
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`also Silver Decl., ¶¶62, 69. That is incorrect for at least two independent reasons.
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`First, as explained above, the plain and ordinary meaning of the term
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`“tightly engage” according to Dr. Silver does not exclude a projection that
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`punctures the artery wall. Second, as explained below, Kornberg discloses
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`innumerable embodiments in which the projections would not puncture the arterial
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`wall, any more than the device of the ‘417 patent, because the Kornberg
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`projections are squarely within the height parameters disclosed in the ‘417 patent
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`for projections.
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`The ‘417 patent discloses (but does not claim) that the projection height
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`should be “in the range of approximately 1.0 mm to 1.5 mm” for use in an aorta. Id.
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`at 8:33-35. Kornberg discloses embodiments of projections for an aortic graft that
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`are clearly in this range. Specifically, Kornberg’s projections have a length of “2
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`to 8 mm” (id., 4:40-42) that are oriented at an acute angle to the direction of blood
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`flow, specifically “about 10º-45º” (id., 3:60-65) including an embodiment depicted
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`in Fig. 2 with “about a 30 degree angle” (id., 4:28-29). See also Silver Tr., 115:22-
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`119:14. The height of the projection equals the sin of the angle multiplied by the
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`projection length. Silver Tr., 48:24-49:13. At a 10º angle, the height of the
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`projection having a length 8 mm (the maximum length of a projection in Kornberg)
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`would be only 1.389 mm, below the maximum height for the projection disclosed
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`in the ‘417 patent. Silver Tr., 123:19-124:3. At a 45º angle (the maximum angle of
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`a projection in Kornberg), the height of a projection having a length of 2 mm
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`would be 1.414 mm, below the maximum height for the projection disclosed in the
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`‘417 patent. Id., at 119:24-121:12. At a 30º angle (the angle of the projection
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`illustrated in Fig. 2 of Kornberg), the height of a projection having a length of 3
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`mm would be 1.5 mm, within the maximum height for the projection disclosed in
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`the ‘417 patent. Id., at 125:1-16.
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`Thus, Kornberg discloses a plethora of embodiments – including all the
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`embodiments at the 10º angle, all the embodiments having a length of 2 mm, and
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`many of the embodiments at a 30º angle of Figure 2 – in which the height of the
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`projection is within the maximum height for the projection disclosed in the ‘417
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`patent. See Silver Tr., 121:13-124:2, 122:10-16; 123:19-124:11; 125:1-16.
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`Dr. Silver concedes that if the projections disclosed in the ‘417 patent do not
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`puncture the arterial wall, neither do the Kornberg projections having a height of
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`1.5 mm or less. Id., at 128:1-8. That is confirmed by the fact that “the aortic wall
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`is typically only about 2 mm thick” (Silver Decl., ¶68) such that a projection with a
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`height of 1.5 mm or less would not puncture the arterial wall. It is further
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`confirmed by the fact that Dr. Silver agrees that there is no need for the a resilient
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`ring in Kornberg if the vessel is not punctured (Silver Tr., 128:4-8) and Kornberg
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`specifically mentions eliminating the resilient ring (Kornberg at 4:15-16).
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`The only other reason the Patent Owner offers as to why the whereupon
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`clause is not met is that the Kornberg device is fully (securely) engaged upon
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`deployment and, therefore, tight engagement is not caused by blood flow. Resp.
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`§IV.B. at 34-36; see also Silver Decl., ¶¶62, 76. This argument is equally without
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`merit because blood flow forces do cause the Kornberg projections to “tightly
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`engage” to the vessel in which the stent is placed.
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`Specifically, blood forces will apply a force to the Kornberg projections to
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`cause the stent to be tightly engaged and remain in place. Rowe Decl., ¶¶14, 24-26.
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`“The downward flow of the blood” described in Kornberg (at 6:24-27) would be
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`transmitted directly to the projections, and the resulting force would drive the tip of
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`the projection into the vessel (Rowe Tr., 116:11-117:15). That is because “if
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`something [like the projections in Kornberg] is engaged but has room to further
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`engage, then force could absolutely drive it further.” Rowe Tr., 117:24-118:17.
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`Indeed, even Dr. Silver testified that, after implantation, blood forces continue to
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`act on the Kornberg projections (Silver Tr., 128:14-16, 129:17-130:1, 131:13-23,
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`143:23-144:5), that such forces are “holding” and “pushing” on the projections (id.
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`at 144:3-5), and might on occasion even damage the device (id. at 143:23-144:5).
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`This is consistent with numerous prior art references because, as Dr. Silver
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`confirmed, Dr. Rhodes was not the first to recognize the use of blood flow to cause
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`an anchoring device to tightly engage to prevent migration. Silver Tr., 147:14-24,
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`148:1-14, 150:7-13, 157:3-8. By way of example, prior art cited by the Patent
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`Owner in its Response (at 7) discuss the use of blood forces to anchor stents into a
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`vessel. See, e.g., Chuter, 10:33-39 (“barb tips 13 will become imbedded in the wall
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`through both the driving action of the spring assembly 6 [of the graft 1] and the
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`pressure created by the flow of blood through the graft 1 … to provide a more
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`secure anchor in the direction of blood flow.”) (emphasis added)). See also
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`Lazarus, 5:53-57 and 10:18-19 (discloses acute-angled projections 70 and that “the
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`internal pressure of the fluid within the lumen 90 holds the graft 12 in place.”).
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`III. THE CLAIMS ARE OBVIOUS OVER THE ‘154 PATENT IN VIEW
`OF KORNBERG
`A. The ‘154 Patent Discloses the Same Device as the ‘417 Patent
`Except for the Expressly Claimed Angle of the Projections
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`The only difference between the alleged invention of the ‘417 patent and the
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`device described in the ‘154 patent lies in the differences between the projections
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`of the two patents. See ‘417, 5:10-17. Moreover, the only structural difference
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`between the projections of the ‘154 patent and the projections in claim 1 of the
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`‘417 patent is that the ‘154 patent is silent as to their angle (Silver Tr. at 85:16-21)
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`whereas claim 1 provides that the trailing portion of the projections are
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`“preferentially oriented to extend at an acute angle to the [direction of blood flow].”
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`However, the selection of an acute angle is an obvious design choice.
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`The projections of the ‘154 patent are necessarily either obtuse, acute, or
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`perpendicular. Silver Tr., 85:2-24; Gupta Tr., 101:4-17. Given the extremely
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`limited alternatives, it would have been obvious to try an acute angle, as disclosed
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`in Kornberg (see §II.C.3 above), to reduce downward migration. Gupta Tr., 101:4-
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`17; Gupta Decl., ¶¶32-33; Rowe Decl., ¶14. See also KSR Int'l Co. v. Teleflex, Inc.,
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`550 U.S. 398, 421 (2007) (“the fact that a combination was obvious to try might
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`show that it was obvious under § 103” when “there are a finite number of
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`identified, predictable solutions [alternatives]”).
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`Indeed, Dr. Silver acknowledged that one of ordinary skill in the art would
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`have used acute projections. Silver Tr., 91:13-20 and 92:3-12.1 Selecting an acute
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`angle for the projections in the ‘154 patent would necessarily and inherently result
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`in blood flow forces acting on the projections to thereby cause them to more tightly
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`engage with the vessel wall. Rowe Decl., ¶¶14, 22-28; see also Silver Tr., 83:3-13
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`(conceding blood flow forces act on the projections in the ‘154) and 131:13-23
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`1 Dr. Silver’s argument that he would have used acute and obtuse projections
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`(Silver Tr., 91:13-20, 92:3-12) is immaterial to the obvious analysis because the
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`claims do not exclude use of obtuse projections with the claimed acute projections.
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`(conceding blood flow forces act on the acute-angled projections in Kornberg). As
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`discussed above in §II.C.3, numerous prior art references recognized the use of
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`blood flow to cause the device to tightly engage to prevent migration, as Dr. Silver
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`conceded at his deposition. Silver Tr., 147:14-24, 148:1-15, 150:7-13, 157:3-8.
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`In its Response, the Patent Owner implies that a reference in the ‘417 to the
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`“small dome shaped projections” of the ‘154 (‘417 at 3:21-24) is significant. Resp.
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`at 41. It is not. The ‘417 states that “the projections need not include sharp edges
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`and/or planar surfaces or points, and can be rounded, domed, or any other suitable
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`shape, so long as they are preferentially oriented to project or extend at some acute
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`angle to the direction of fluid flow.” ‘417 at 9:1-8. Thus, the shape of the
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`projections of the ‘154 is consistent with the disclosure and claims of the ‘417.
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`And there is nothing in the ‘154 or ‘417 suggesting that the size of the projections
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`in the two patents is meaningfully different. To the contrary, the ‘417 claims do
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`not mention projection size, and a comparison of the figures in the patents
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`indicates that the size and location of the projections are the same in both patents.
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`See Gupta Decl., ¶24 (comparing Figs. 1 & 8 of ‘154 to Figs. 1 & 2 of ‘417).
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`In its Response, the Patent Owner argues that one would not combine the
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`teachings of Kornberg and ‘154 because Kornberg uses “active fixation” (staples,
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`barbs or hooks to secure the stent graft) while ‘154 uses only “passive fixation”
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`(friction forces to secure the stent graft), two terms not used in either reference or
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`the ‘417 patent. Resp. at 9-10, 45-46. That argument fails for at least two reasons.
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`First, the projections in the ‘154 have an active fixation component as they “help
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`impact the graft into the arterial wall to maintain a fixed position therein.” (‘154,
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`7:22-24). Second, the benefit of stent grafts utilizing both passive and active
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`fixation were well-known before the filing of the ‘417 patent. Representative
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`examples include prior art cited in the Patent Owner’s Response. See, e.g.,
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`Tessman, 1:20-24, 1:41-42 (explaining “[i]t would be advantageous to have a
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`stent … which had a more reliable means than just frictional contact to prevent
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`migration of the stent from the body passage” and describing an embodiment in
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`which “the anchoring means [further] includes a plurality of sharp unidirectional,
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`hook-like projections.”); Chuter, at 4:4-6,4:51-53 (disclosing a stent graft
`
`“expandable radially to substantially conform to the interior wall of a lumen” and
`
`has barbs to secure the stent graft within the lumen in which it is placed). These
`
`references inform the obviousness of the combination of the ‘154 with Kornberg.
`
`There Are No Secondary Indicia of Non-Obviousness
`
`B.
`The Patent Owner points to a settlement agreement with a third party as
`
`evidence of commercial success, citing only to Dr. Silver’s declaration. Resp. at
`
`55-56; Silver Decl., ¶106. However, the agreement cannot be relied upon as
`
`evidence of commercial success because Dr. Silver admitted that he has never seen
`
`the agreement and has no knowledge regarding its contents. See Silver Tr., 190-
`
`404793467v1
`
`13
`
`
`
`193. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1324 (Fed. Cir.
`
`2014) (“Our cases specifically require affirmative evidence of nexus where the
`
`evidence of commercial success presented is a license, because it is often cheaper
`
`to take licenses than to defend infringement suits”) (inner quotation marks omitted).
`
`The Patent Owner claims commercial success based on products on the
`
`market, citing only to Dr. Silver’s declaration and a few pieces of literature. Resp.
`
`at 55; Silver Decl., ¶¶104-105. However, the Patent Owner presents no credible
`
`evidence: (1) that these products actually embody the claims of the ‘417 patent
`
`(Silver Decl., ¶104, stating products embody the claimed inventions but offering
`
`no analysis); (2) that these products have met with commercial success (id., ¶104,
`
`stating products “have achieved sales representing a substantial proportion of the
`
`market,” without offering any sales or market data); or (3) that any supposed
`
`commercial success is attributable to use of the claimed inventions (id., ¶105,
`
`stating that a manufacturer touts benefits of “a combination of active fixation,
`
`radial force, and columnar strength,” which is not the invention claimed in the ‘417)
`
`(see also Silver Tr., 186:8-187:4, admitting he did not consider the many factors
`
`unrelated to the purported invention of the ‘417 patent that may have contributed to
`
`commercial success). See Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311-
`
`12 (Fed. Cir. 2006) (“Evidence of commercial success ... is only significant if there
`
`is a nexus between the claimed invention and the commercial success.”).
`
`404793467v1
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`14
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`
`
`Finally, the Patent Owner contends that the invention of the ‘417 patent
`
`satisfied a long-felt need. Resp. at 51-54. “[L]ong-felt need is analyzed as of the
`
`date of an articulated identified problem and evidence of efforts to solve that
`
`problem.” Texas Instruments Inc. v. Int'l Trade Comm'n, 988 F.2d 1165, 1178 (Fed.
`
`Cir. 1993). The Patent Owner, however, alleges that at the time of his invention,
`
`he was the only one that “recognized that there was a problem with existing
`
`methods of anchoring to ensure good securement against downstream migration
`
`that an intraluminal device experiences when deployed within a blood vessel” (id.,
`
`¶95). No one else “recognized the complexities of this problem or attempted to
`
`provide a solution that would solve it in all respects.” Id., ¶99. There can be no
`
`“long-felt need” given the positions taken by the Patent Owner. See In re Gershon,
`
`372 F.2d 535, 539 (CCPA 1967) (there can be no long-felt need where “the alleged
`
`problem … was first recognized by appellants, and others apparently have not yet
`
`become aware of its existence”).
`
`IV. CONCLUSION
`Petitioner respectfully requests that the Board cancel claims 1, 2, 9, 10, and
`
`13 as anticipated by Kornberg, and obvious over the ‘154 in view of Kornberg.
`
`
`
`Date: September 25, 2014
`
`
`Respectfully submitted,
`
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`
`
`/Jack S. Barufka/
`
`Jack S. Barufka, Reg. No. 37,087
`
`
`
`
`
`404793467v1
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`15
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)(4))
`I hereby certify that a true copy of the PETITIONER’S REPLY TO
`
`PATENT OWNER’S RESPONSE was served electronically by email this 25th day
`
`of September, 2014 on the attorneys of record for the Patent Owner:
`
`Matthew Phillips
`(matthew.phillips@renaissanceiplaw.com)
`Renaissance IP Law Group LLP
`9600 S.W. Oak St., Suite 560
`Portland, OR 97223
`
`Brett M. Pinkus
`(pinkus@fsclaw.com)
`Jonathan T. Suder
`(jts@fsclaw.com)
`Friedman, Suder & Cooke
`604 E. Fourth Street, Suite 200
`Fort Worth, TX 76102
`
`
`
`
`
`
`Date: September 25, 2014
`
`
`
`
`
`
`
`P.O. Box 10500
`McLean, VA 22102
`(703) 770-7900
`
`
`
`
`404793467v1
`
`Respectfully submitted,
`
`PILLSBURY WINTHROP SHAW PITTMAN LLP
`
`
`
`/Jack S. Barufka/
`
`
`
`
`
`
`
`
`
`
`
`Jack S. Barufka
`Reg. No. 37,087
`Tel. No. 703.770.7712
`Fax No. 703.905.2500
`
`
`
`1
`
`
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