Trials@uspto.gov
`Tel: 571-272-7822
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`Paper 46
` Entered: March 24, 2015
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`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 and ENDOTACH LLC,
`Patent Owner.
`____________
`
`Case IPR2014-00100
`Patent 5,593,417
`____________
`
`
`
`Before JACQUELINE WRIGHT BONILLA, MICHAEL J. FITZPATRICK, and
`HYUN J. JUNG, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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`Case IPR2014-00100
`Patent 5,593,417
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`I.
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`INTRODUCTION
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`A. Background
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`Petitioner Medtronic, Inc. and Medtronic Vascular, Inc. (“Petitioner”) filed a
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`corrected Petition (Paper 5, “Pet.”) to institute an inter partes review of claims 1,
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`2, 9, 10, and 13 of U.S. Patent No. 5,593,417 (Ex. 1001, “the ’417 patent”).
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`35 U.S.C. § 311. Patent Owner, the Marital Deduction Trust, and its exclusive
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`licensee Endotach LLC (“Patent Owner”)1 did not file a Preliminary Response.
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`We determined that the information presented in the Petition demonstrated that
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`there was a reasonable likelihood that Petitioner would prevail in challenging
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`claims 1, 2, 9, 10, and 13 of the ’417 patent as unpatentable. Paper 15 (“Dec. to
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`Inst.”), 2, 15. Pursuant to 35 U.S.C. § 314, we instituted this proceeding on March
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`25, 2014, to review whether Kornberg2 anticipates claims 1, 2, 9, 10, and 13 of the
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`’417 patent under 35 U.S.C. § 102, and also whether those claims would have been
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`obvious over Rhodes ’1543 and Kornberg under 35 U.S.C. § 103. Dec. to Inst. 15.
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`After institution of trial, Patent Owner filed a Patent Owner Response.
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`Paper 27 (“PO Resp.”). Petitioner subsequently filed a Reply to the Response.
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`Paper 35 (“Reply”). An oral hearing was held on November 20, 2014. A
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`transcript of the hearing has been entered into the record. Paper 44 (“Tr.”).
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`1 Patent Owner indicates that the Marital Deduction Trust, created under the
`Valentine J. Rhodes Revocable Trust, is the owner of the ’417 patent, while
`Endotach LLC is the exclusive licensee of all substantial interests of the patent.
`Paper 10, 2; Paper 20, 2.
`2 Kornberg, U.S. Pat. No. 4,562,596, issued Jan. 7, 1986 (“Kornberg”) (Ex.1006).
`3 Rhodes, U.S. Pat. No. 5,122,154, issued June 16, 1992 (“Rhodes ’154”) (Ex.
`1008).
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`We have statutory authority under 35 U.S.C. § 6(c). This Final Written
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`Decision is issued pursuant to 35 U.S.C. § 318(a). Petitioner has shown by a
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`preponderance of the evidence that claims 1, 2, 9, 10, and 13 of the ’417 patent are
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`unpatentable.
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`B. Related Matters
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`Petitioner indicates that Patent Owner has asserted the ’417 patent against it
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`in Endotach LLC v. Medtronic, Inc., No. 5:13-cv-03292-EJD (N.D. Cal.). Pet. 1.
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`In its Mandatory Notices, Patent Owner identifies two other cases that may affect
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`or be affected by this proceeding: Endotach LLC v. Cook Medical Inc., No. 1:13-
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`cv-1135 (S.D. Ind.) and Endotach LLC v. W.L. Gore & Associates, Inc., No. 3:12-
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`cv-00308 (N.D. Fla.). Paper 10, 2–3; Paper 20, 2–3.
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`On April 25, 2014, after we instituted a trial in the current case, Petitioner
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`filed another Petition in Case IPR2014-00695, involving the same parties and same
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`claims of the ’417 patent at issue in this proceeding. IPR2014-00695, Paper 1
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`(“Second Petition”). Petitioner also filed a Motion for Joinder requesting “that the
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`Second Petition be joined with IPR2014-00100.” IPR2014-00695, Paper 2, 2. The
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`Second Petition reasserted two grounds of unpatentability previously asserted in
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`this proceeding, as well as three new grounds relying on two additional references.
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`Second Petition 10–11, 13–32. In a Decision dated September 25, 2014, we denied
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`Petitioner’s Motion for Joinder, as well as Petitioner’s Second Petition. IPR2014-
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`00695, Paper 18, majority op. at 9.
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`C. The ’417 Patent (Ex. 1001)
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`The ’417 patent relates to an intraluminal medical device, such as an
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`endovascular graft or stent. Ex. 1001, 3:45–48. The patent discusses U.S. Pat.
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`No. 5,122,154 (Ex. 1008, “Rhodes ’154”), also relating to an intraluminal graft.
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`Ex. 1001, 2:64–3:27. The ’417 patent states the present graft device “is
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`constructed in accordance with the teachings of my aforementioned patent [Rhodes
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`’154], except for the means for fixedly holding it in place within the vessel, duct,
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`or lumen,” i.e., the “anchoring means.” Id. at 5:10–17.
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`Figures 2, 3, 7, and 8 of the ’417 patent are reproduced below.
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`Figure 2 depicts a portion of an endovascular bypass graft. Id. at 4:47–52.
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`Figure 3 depicts an enlarged view of the portion in Figure 2 designated as “FIG. 3”
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`with broken lines. Id. at 4:53–55. Figure 7 depicts another embodiment of a graft.
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`Id. at 4:65–67. Figure 8 depicts an enlarged sectional view taken along line 8-8 of
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`Figure 7. Id. at 5:1–2.
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`In Figure 2, the graft comprises tubular member 24 having a plurality of
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`expandable, ring-like, stent members 26. Id. at 5:54–59. Each stent member 26
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`comprises a plurality of links 30, where each link is joined to another link by joint
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`32. Id. at 6:21–32. “In order to help hold or secure the graft in position in the
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`artery (or lumen or duct) once the graft has been expanded,” the graft includes
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`anchoring means comprising projections 40. Id. at 7:9–13. Figure 3 shows details
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`of an embodiment of “arrow head” projections 40 on joint 32. Id. at 7:60–63.
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`Each projection “includes a leading edge 42 defining the ‘tip’ of the ‘arrow-head,’”
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`where “leading edge 42 extends upward at an acute angle to the exterior surface of
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`the stent and terminates at the top surface 44 of the projection.” Id. at 7:63–67; see
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`also Fig. 4. The projections also include trailing edges 48, 50, and 52, each of
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`which “inclines upward in the direction of the blood flow to terminate at the top
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`surface 44.” Id. at 8:2–6.
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`In another embodiment, shown in Figures 7 and 8, projections 70 are
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`“wedge” shaped. Id. at 8:54–56. Leading surface 72 defines “the ‘front face’ of
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`the ‘wedge,’” and “extends upward at an acute angle to the exterior surface of the
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`stent and terminates at the top surface 74.” Id. at 8:56–58. The projections also
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`include “trailing surface 76 which inclines upward in the direction of the blood
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`flow to terminate at the top surface 74 in a penetration edge 78,” and “are
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`preferentially oriented at an acute angle to the direction of blood flow.” Id. at
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`8:58–67.
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`D. Illustrative Claim
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`Claim 1, the only challenged independent claim, is reproduced below.
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`1. An intraluminal medical device for securement within a vessel, duct, or
`lumen of a living being, the vessel, duct, or lumen having an interior surface,
`said device comprising a tubular member and anchoring means,
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`said tubular member having a passageway extending therethrough and
`an outer periphery, said tubular member being arranged to have a body fluid
`flow through said passageway in a first direction when said device is located
`within the vessel, duct, or lumen, whereupon a force is applied to said
`tubular-member,
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`said anchoring means being located adjacent said outer periphery of
`said tubular member and comprising plural projections arranged for
`engagement with the interior surface of the vessel, duct, or lumen,
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`each of said projections having a leading portion located in the
`upstream direction of the fluid flow and a trailing portion located in the
`downstream direction thereof, said trailing portion including at least one
`surface preferentially oriented to extend at an acute angle to the first
`direction,
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`whereupon the force applied to said tubular member by the fluid
`flowing through said passageway produces on each of said projections a
`force component to cause said at least one surface to tightly engage the
`interior surface of the vessel, duct, or lumen to fixedly secure said device in
`place.
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`Id. at 9:23–45 (paragraph indentation added).
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`II. ANALYSIS
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`A. Claim Construction
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`In an inter partes review, “[a] claim in an unexpired patent shall be given its
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`broadest reasonable construction in light of the specification of the patent in which
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`it appears.” 37 C.F.R. § 42.100(b); see also In re Cuozzo Speed Tech., LLC, No.
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`2014-1301, 2015 WL 448667, at *5–*8 (Fed. Cir. Feb. 4, 2015) (“Congress
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`implicitly adopted the broadest reasonable interpretation standard in enacting the
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`AIA,” and “the standard was properly adopted by PTO regulation”). There is a
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`“heavy presumption” that a claim term carries its ordinary and customary meaning.
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`CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002); In re
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`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). A patentee may
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`rebut this presumption, however, by acting as his own lexicographer, providing a
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`definition of the term in the specification with “reasonable clarity, deliberateness,
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`and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). In the absence
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`of such a definition, limitations are not to be read from the specification into the
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`claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993).
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`1. “Projection,” “Leading Portion,” “Trailing Portion,” and “Stent”
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`Petitioner offers constructions for the terms “projection,” “leading portion,”
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`and “trailing portion” recited in claim 1, as well as “stent” recited in claims 9, 10,
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`and 13. Pet. 9–12. Upon review of the Specification of the ’417 patent and the
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`challenged claims, we construe “projection” to mean a structure that extends
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`outward from a surface, such as a surface of a stent. Additional claim language
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`indicates that the projection comprises a leading portion and a trailing portion,
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`where the projection is capable of engaging with an interior surface of a vessel,
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`duct, or lumen in a living being. Ex. 1001, 3:21–24, 7:9–59, claim 1. The “leading
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`portion” of a projection is located in an upstream direction of fluid flow, while the
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`“trailing portion” is located in the downstream direction of fluid flow. Id. at claim
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`1; Pet. 10–11. For example, as shown in Figure 8 of the Specification, leading
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`surface 72 corresponds to a leading portion (oriented upstream from the direction
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`of blood flow), while trailing surface 76 corresponds to a trailing portion (oriented
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`downstream from the direction of blood flow). In addition, we construe “stent” to
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`mean any structure that provides structural support, such as for a blood vessel,
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`duct, or lumen. Ex. 1001, 2:12–14, 3:45–48; Pet. 11.
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`2. “At Least One Surface”
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`Patent Owner contends that the phrase “at least one surface” in relation to
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`the “trailing portion” in claim 1 refers to “a portion, part or surface of the trailing
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`portion of a projection which is oriented at an acute angle to the fluid flow,” as
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`recited in claim 1. PO Resp. 25–26. We note that claim 1 recites in relevant part
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`that the trailing portion includes “at least one surface preferentially oriented to
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`extend at an acute angle to the first direction.” In view of the Specification, we
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`interpret this limitation as proposed by Patent Owner, i.e., as referring to a
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`structural limitation indicating direction. Id.; Tr. 37–38. Petitioner does not
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`disagree with this construction.
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`3. “Engagement With” and “Engaging”
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`Patent Owner contends that “engagement with” and “engaging,” as recited in
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`claim 1, require no construction, and the plain and ordinary meaning applies. PO
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`Resp. 26. We generally agree but clarify that those terms mean contacting in some
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`fashion. See, e.g., Transcript of Deposition of James Silver, Ph.D., Ex. 1014,
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`22:13–20 (Dr. Silver testifying that “engage would mean that the device was in
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`contact with the vessel wall”); Order on Claim Construction (S.D. Ind. 2013), Ex.
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`2013, 34.
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`4. “Tightly Engage”
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`Patent Owner contends that “tightly engage” means more than “engage” in
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`that it describes the degree of connection between the projections and interior
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`surface of the vessel, duct, or lumen. PO Resp. 26. Patent Owner notes that claim
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`1 recites that a “force from the fluid flowing through” the tubular member
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`produces a force “to cause” a surface of the trailing portion “to tightly engage the
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`interior surface of the vessel, duct, or lumen to fixedly secure said device in place.”
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`Id. at 27; Ex. 1001, claim 1.
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`Referring to this claim language, Patent Owner contends that being “fixedly
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`secure” occurs as a result of forces from blood flow only, but not other forces, such
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`as manual force exerted by a physician, or force from a balloon or stent itself. Id.
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`at 30. Patent Owner also contends, citing certain portions of the Specification, that
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`a surface of the trailing portion tightly contacts or penetrates, i.e., tightly engages,
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`only the interior surface of the vessel wall, i.e., “the intima (inner) layer, but not
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`into the medial (middle) or adventitial (outer) layers.” Id. at 27–29 (citing
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`Ex. 1001, 8:28–30, 3:53–57).
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`We agree with Patent Owner that “tightly engage” means more than simply
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`“engage.” The Specification of the ’417 patent does not define “tightly” per se.
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`Rather, it states that a force of fluid, e.g., blood flow, causes projections “to tightly
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`engage, e.g., burrow slightly into, the interior of the wall of the vessel, duct, or
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`lumen to thereby fixedly secure the device in place.” Ex. 1001, 4:13–25, 34–39,
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`7:17–32. The Specification also states that projections “tightly engage (and not
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`necessarily penetrate) the interior of the wall of the vessel, duct, or lumen to
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`fixedly secure the device in place against migration.” Id. at 9:1–17. It also
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`indicates that projections can “penetrate or burrow slightly into the artery wall.”
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`Id. at 8:19–23, 42–45. Thus, the Specification clarifies that “tightly engage”
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`encompasses burrowing slightly into, penetrating, or not necessarily penetrating, a
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`blood vessel wall.
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`In relation to a particular embodiment, shown in Figure 4, the Specification
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`states that “[i]f some penetration is deemed desirable the height of the projections
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`is selected so that their penetrating points do not penetrate too deeply into the
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`artery wall,” i.e., “the height of the projections is selected so that they do not
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`penetrate into the adventicial or medial layers of the artery wall, but can penetrate
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`its intima.” Id. at 8:22–31. Notwithstanding that discussion, we do not read the
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`Specification as a whole to require that “tightly engage” precludes projections
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`penetrating adventicial or medial layers of an artery wall. Instead, the
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`Specification states that an object of the invention is to provide anchoring means
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`that do “not pose a significant risk of perforating the tissue of the vessel, duct, or
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`lumen.” Id. at 3:53–58.
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`Thus, we construe “tightly engage” in claim 1 to mean that trailing portions
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`of the recited projections are structurally capable of contacting, burrowing into, or
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`penetrating into an interior surface of a vessel, duct, or lumen in a manner that
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`fixedly secures the device in place, without posing “a significant risk of perforating
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`the vessel, duct, or lumen” altogether. Id. The projections and their trailing
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`portions must be structurally capable of allowing a fluid flow force, e.g., blood
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`flow, through the tubular member to help cause and maintain the tight engagement
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`of the projections, and keep the device securely in place, even if other forces, such
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`as manual force by a physician, are also involved in deploying the device initially.
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`See, e.g., Ex. 1001, 7:9–33 (stating that “to help hold or secure the graft in position
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`in the artery (or lumen or duct) once the graft has been expanded, the graft
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`includes . . . anchoring means” comprising “plural protuberances or projections
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`40”), 3:35–37, 8:11–45 (stating that “flow of fluid, e.g., blood, through the device
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`20 will tend to force the projections 40 into good engagement” and “penetration
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`may not be necessary for good resistance to migration of the device”); Declaration
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`of James Silver, Ph.D., Ex. 2002 ¶ 45.
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`B. Anticipation by Kornberg
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`Petitioner argues that Kornberg anticipates claims 1, 2, 9, 10, and 13 of the
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`’417 patent. Pet. 8, 19–22.
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`1. Kornberg (Ex. 1006)
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`Kornberg describes a tubular graft comprising “a plurality of struts or stays
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`equipped with hooks for rapid and secure attachment within the desired location of
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`the damaged artery.” Ex. 1006, 2:15–19. Figures 1 and 2 of Kornberg are
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`reproduced below.
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`Figure 1 depicts an aortic bifurcation graft equipped with a circumferential row of
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`hooks 14 and a plurality of longitudinal struts 12. Id. at 2:23–27. Figure 2 depicts
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`an enlarged view of the upper end of a single strut 12 with hook 14 having barb 15.
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`Id. at 2:28–29.
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`Kornberg states that graft 10 “must have support along its length, so that the
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`blood flow does not dislodge it,” but the graft “is sufficiently flexible to be capable
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`of conforming to the interior contour of the wall portion of the artery into which it
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`is inserted.” Id. at 2:56–62. Graft 10 “is a generally cylindrical, hollow, bifurcated
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`sleeve with longitudinal supporting and reinforcing members called struts 12
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`running along the major axis of the cylindrical sleeve.” Id. at 2:62–65. For
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`instance, as shown in Figure 1, struts 12 run along the length of legs (10A and
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`10B) of graft 10 and “assure proper orientation of the graft within the artery.” Id.
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`at 2:62–68; 4:17–20. As described in Kornberg, “the number of circumferential
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`located strengthening struts or ribs 12 attached or formed in the wall of the graft
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`may vary from a minimum of four up to twelve or more, preferably eight.” Id. at
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`3:1–5. Graft 10 also includes flexible ring 16 at the upper end of the graft. Id. at
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`4:6–9.
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`Hooks 14 are located at the upper end of each strut 12, and a “row of hooks
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`14 forms a ring around the outer circumference of graft 10 and are oriented
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`downwardly at an angle of about 10º–45º C. with respect to the vertical.” Id. at
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`3:60–65; see also id. at 4:28–30 (stating that hook 14 is at an angle of about 30º in
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`Figure 2). Hook lengths are “typically 2 to 8 mm.” Id. at 4:40–42; Ex. 2002 ¶ 68.
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`As described in Kornberg, “[e]ach hook 14 has a barb 15 located at the lower end
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`of the hook so as to inhibit upward movement which might tend to dislodge the
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`graft after it is positioned and attached to the aorta wall.” Ex. 1006, 3:66–4:1.
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`Kornberg also describes, referring to Figure 9, that “downward flow of
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`blood holds the distal graft limbs 10A and 10B in place so that no mechanical
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`attachment is necessary distally,” and that the “flow mechanism of the blood keeps
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`the graft open.” Id. at 6:20–30. In relation to Figure 10, Kornberg describes that
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`the “aortic wall at the neck of the aneurysm 56 is pierced by the multiple radially
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`placed hooks 14. These puncture wounds are then excluded from the blood flow
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`by the snug fit provided by the flexible ring 16 at the top of the graft.” Id. at 6:40–
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`47. Kornberg also contemplates that one could make its graft without ring 16. Id.
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`at 4:6–16.
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`2. Analysis—Claim 1
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`Petitioner contends that Kornberg discloses each and every element of claim
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`1, referring to annotated versions of Figures 1, 2, and 9 in Kornberg and
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`disclosures in the reference, as well as a claim chart and a Declaration by Travis
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`Rowe. Pet. 19–22, Appx. A2, 5–9; Declaration of Travis Rowe, Ex. 1003 ¶¶ 22–
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`26. For example, Petitioner points to disclosure in Kornberg as corresponding to
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`certain elements in claim 1 as follows:
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`Element in claim 1
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`Disclosure in Kornberg
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`“intraluminal medical device”
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`Graft 10
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`“tubular member”
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`Struts 12 and ring 16
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`“anchoring means” comprising “plural
`projections”
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`Hooks 14
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`Pet. 20, Appx. A2, 5–7.
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`In relation to the “leading portion” and “trailing portion” of the projections
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`recited in claim 1, Petitioner provides annotated figures from Kornberg, including
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`annotated Figure 2, reproduced below.
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`Pet. 20. Annotated Figure 2 depicts Figure 2 of Kornberg (shown previously),
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`with added designations including “Leading Portion,” “Upstream,” “Trailing
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`Portion,” “Acute Angle,” “Downstream,” and an arrow indicating “Fluid Flow
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`(‘First Direction’).” Id.
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`Petitioner contends that hooks 14 are located adjacent to the outer periphery
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`of the tubular member (struts 12 and ring 16) in Kornberg’s graft 10. Id.
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`According to Petitioner, each hook 14 includes a “leading portion,” as designated
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`in annotated Figure 2, located in the upstream direction of fluid flow, as recited in
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`claim 1. Id. Petitioner further contends that each hook includes a “trailing
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`portion,” as also designated in annotated Figure 2, located in the downstream
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`direction of fluid flow, which includes a portion that is oriented to extend at an
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`acute angle to the fluid flow, as also recited in claim 1. Id. at 20–21.
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`In relation to the last “whereupon” clause in claim 1, Petitioner also
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`contends, relying on the Rowe Declaration, that:
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`force applied to the manually-anchored tubular member (“struts 12
`and ring 16”) of Kornberg by fluid flowing through the interior
`passageway thereof inherently produces on each of the projections
`(“hooks 14”) a force component that causes at least one surface of the
`trailing portion to tightly engage the interior surface of the vessel,
`duct, or lumen to fixedly secure the device (“graft 10”) in place.
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`Id. at 21 (citing Ex. 1003 ¶¶ 22–26). Petitioner also points us to Kornberg’s
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`Abstract, which describes “struts having angled hooks with barbs at their upper
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`ends, the upper ends of the struts extending beyond the upper end of the tubular
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`material, thus allowing the graft to be securely attached to the inside of the aorta.”
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`Ex. 1006, Abstract; Pet. Appx. A2, 7–8.
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`Patent Owner responds, relying on a Declaration by Dr. James Silver (Ex.
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`2002). PO Resp. 1. First, Patent Owner contends that Kornberg discloses that its
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`graft projections fully engage upon completion of the device’s deployment, and
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`therefore, Kornberg fails to disclose that fluid flow forces cause projections to
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`engage after deployment. Id. at 1, 13. Patent Owner contends that, when using
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`Kornberg’s device, “blood flow forces would either have no effect on the amount
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`of securement provided by the anchors or force the anchors to further penetrate the
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`vessel such that there would be an increased risk of damage to the vessel wall,
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`or . . . the anchor itself.” Id. at 13–14 (citing Ex. 2012; Ex. 2023, 76:5–81:25;
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`Ex. 2021, 52:9–14, 132:16–25; Ex. 2002 ¶¶ 44, 47). Patent Owner also refers to
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`Patent 5,593,417
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`the prosecution history of the ’417 patent, arguing that inventor Dr. Rhodes
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`addressed “the need for the fluid force to help secure the graft in place versus
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`previous stent graft attachment methods.” PO Resp. 15–17.
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`Along these lines, Patent Owner contends that “[w]hile forces from the fluid
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`flow acting on the graft 10 may inherently exist and keep the graft 10 open,
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`Kornberg does not teach or suggest that such fluid flow forces are what causes the
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`at least one surface of the trailing portion of the hooks 14 to tightly engage the
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`vessel wall.” Id. at 35 (citing Ex. 2023, 80:1–7; Ex. 2002 ¶ 73). According to
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`Patent Owner, Kornberg’s device is “fixedly secured in place against migration”
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`by manual force exerted by a physician, such that trailing portions of hooks 14
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`fully penetrate a vessel wall during deployment, and thereafter, the hooks “would
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`not experience any further gain in fixation against migration resistance as a result
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`of the blood flow forces.” PO Resp. 35–36 (citing Ex. 2023, 80:14–25, 81:8–25;
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`Ex. 2002 ¶¶ 74, 76, 77).
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`Petitioner establishes by a preponderance of the evidence that Kornberg’s
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`graft device includes a “tubular member,” and that hooks 14 in Kornberg’s graft
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`device correspond to an “anchoring means” comprising “projections” that each
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`have a “leading portion,” located in the upstream direction of fluid flow, as well as
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`a “trailing portion,” located in the downstream direction of fluid flow, as recited in
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`claim 1. Pet. 20 (including annotated Figure 2 from Kornberg). Petitioner also
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`establishes sufficiently that Kornberg’s projections (hooks 14 with barbs 15) have
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`trailing portions with a surface “oriented to extend at an acute angle to the first
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`direction,” as recited in claim 1. Pet. 20–21 (including annotated Figure 2 from
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`Kornberg), Appx. A2, 6–7.
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`Patent Owner does not contend otherwise. Nor does Patent Owner dispute
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`that Kornberg’s hooks and barbs are structurally capable of penetrating into an
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`Case IPR2014-00100
`Patent 5,593,417
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`interior surface of a vessel in a manner that fixedly secures graft 10 in place. PO
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`Resp. 31–39; Pet. Appx. A2, 7–8 (citing Ex. 1001, Abstract, 3:60–62 (stating that
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`“proximal attachment of the graft 10 to the inside wall of the aorta is accomplished
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`by the hooks 14 which are located at the upper end of each strut 12”)). Rather,
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`Patent Owner relies on the last “whereupon” in claim 1 as providing additional
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`structural limitations, including that the projections are structurally capable of
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`having blood flow force “cause” a relevant surface of hooks 14 to “tightly engage”
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`a blood vessel and “fixedly secure” the device in place. PO Resp. 34–36.
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`In this regard, Kornberg describes that “downward flow of blood holds the
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`distal graft limbs 10A and 10B in place so that no mechanical attachment is
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`necessary distally,” and that the “flow mechanism of the blood keeps the graft
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`open.” Ex. 1006, 6:20–30; Reply 9–10. Because hooks 14 with barbs 15 are part
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`of graft 10 in Kornberg’s device, we are persuaded by Petitioner’s position that
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`blood flow through the interior passageway of Kornberg’s device “inherently
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`produces” a force that helps cause hooks 14, including their trailing portion
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`surfaces, to engage and maintain engagement in the vessel, which fixedly secures
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`the device (“graft 10”) in place. Pet. 21; Reply 9–10.
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`Based on descriptions in Kornberg that blood flow keeps graft 10 open (Ex.
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`1006, 6:23–30), we are not persuaded that blood flow forces would have “no effect
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`on the amount of securement provided by” hooks 14 located on the graft, as Patent
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`Owner contends. PO Resp. 13, 36. Kornberg’s descriptions necessarily imply
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`that, absent forces from blood flow, the graft would not stay open, and therefore,
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`hooks 14 would disengage from the vessel. Thus, a preponderance of the evidence
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`establishes that Kornberg inherently describes projections (hooks 14 with barbs
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`15), including surfaces of trailing portions of the hooks, that are capable of being
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`forced by blood fluid flow to cause engagement with the interior of the vessel to
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`“fixedly secure” the device in place, even if manual forces by a physician put the
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`device and hooks in place initially.
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`We note that evidence submitted by Patent Owner further supports this
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`finding. Patent Owner points us to the Malina article (Ex. 2012), discussing “the
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`importance of using hooks and barbs to properly anchor the graft into the wall to
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`prevent migration after deployment.” PO Resp. 17. Patent Owner quotes that
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`article as stating that the “angle between the stent and its hooks and barbs is
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`important” for the action of the hooks and barbs engaging “the aortic wall when
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`the stent-graft is pulled distally by the bloodstream.” Id. (citing Ex. 2012, 6).
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`Thus, Patent Owner’s own evidence indicates that it is the presence and angles of
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`hooks and barbs, exactly as depicted in Kornberg, that allow blood flow to cause
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`and maintain tight engagement of projections in the vessel and keep the device
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`securely in place.
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`Second, Patent Owner argues, in relation to the last “whereupon” clause in
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`claim 1, that Kornberg’s hooks 14 do not “tightly engage” a blood vessel because
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`Kornberg’s hooks pierce blood vessels, and Kornberg uses ring 16 to cover
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`resulting punctures in the vessel wall. PO Resp. 36–39; Ex. 1006, 4:6–16. Thus,
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`according to Patent Owner, Kornberg does not describe projections that do not
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`pose a significant risk of perforating the vessel, as required in the last whereupon
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`clause in claim 1.
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`Patent Owner acknowledges, as Petitioner contends, that Kornberg discloses
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`a range of hook angles (10°–45°) and hook lengths (2–8 mm), and that certain
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`lower angles and smaller lengths within those ranges would result in hooks being
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`less than the thickness of an aorta vessel wall. PO Resp. 37 (citing Ex. 1006, 3:62–
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`65, 4:40–42; 2002 ¶ 68 (stating that the height of Kornberg’s anchors (hooks 14
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`with barbs 15) “will be from about 0.35 to 5.66 mm, and because the aortic wall is
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`typically only about 2 mm thick, the anchors will penetrate the aorta in the
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`majority of cases”); Reply 7–9. Patent Owner argues, however, that because
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`Kornberg does not describe a specific combination of hook angle and hook length,
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`it does not describe a combination that “would necessarily result in a hook not
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`perforating through the artery wall.” PO Resp. 37–38. Patent Owner further
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`contends that Kornberg lacks “sufficient specificity,” as discussed in Atofina v.
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`Great Lakes Chem. Corp., 441 F.3d 991, 999–1000 (Fed. Cir. 2006), because
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`Kornberg does not disclose or point to any particular embodiment as desirable, but
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`instead emphasizes perforation, as shown in Figure 10 and addressed by ring 16.
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`PO Resp. 38–39.
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`Atofina explains that a reference’s description of a broad genus range (e.g.,
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`broad temperature range) does not anticipate necessarily every species within that
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`range. Atofina, 441 F.3d at 999. Here, however, Kornberg discloses relatively
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`narrow ranges of hook angles (10°–45°) and lengths (2–8 mm), as noted above,
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`and specifically describes an angle of about 30º in the embodiment shown in
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`Figure 2. Ex. 1006, 4:28–29. As Petitioner points out, any hook having a 10º
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`angle (at any described length) and any hook being 2 mm length (at any described
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`angle, including 30º shown in Figure 2) would not penetrate an aorta wall, which is
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`about 2 mm thick. Reply 7–9; see also Ex. 2002 ¶ 68. Moreover, Kornberg
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`expressly describes that its graft could be made without ring 16, indicating that
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`Kornberg contemplates that ring 16 (used to cover “punctures in the aorta”) may be
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`unnecessary in certain embodiments. Reply 9; Ex. 1006, 4:6–16.
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`In addition, Kornberg clarifies that it is the presence of hooks with barbs, at
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`the disclosed locations and angles, as shown in Figures 2 and 5, for example, that
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`“inhibit[s] upward movement which might tend to dislodge the graft after it is
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`positioned and attached to the aorta wall.” Ex. 1006, 3:60–4:1. In this context,
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`Patent 5,593,417
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`although Kornberg describes and depicts hooks that pierce the aorta wall, the
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`reference also discloses hooks that necessarily do not pierce the aorta wall in that it
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`describes smaller angles and lengths for hooks 14, as well as ring 16 being
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`optional. Id. at 3:60–4:46 (describing hook 14 angles and lengths, and attaching
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`the graft to “the aorta wall”).
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`The evidence before us does not persuade us that a “considerable difference”
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`exists between possible (unrecited) ranges of angles and lengths