`Tel: 571-272-7822
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`Paper 15
`Entered: March 25, 2014
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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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`ENDOTACH LLC
`Patent Owner
`____________
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`Case IPR2014-00100
`Patent 5,593,417
`____________
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`Before JACQUELINE WRIGHT BONILLA, MICHAEL J. FITZPATRICK, and
`HYUN J. JUNG, Administrative Patent Judges.
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`BONILLA, Administrative Patent Judge.
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`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
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`Case IPR2014-00100
`Patent 5,593,417
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`I.
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`INTRODUCTION
`A. Background
`Petitioner Medtronic, Inc. and Medtronic Vascular, Inc. (“Medtronic”) filed
`a corrected Petition (Paper 5, “Pet.”) to institute an inter partes review of claims 1,
`2, 9, 10, and 13 of U.S. Patent No. 5,593,417 (Ex. 1001, “the ’417 patent”),
`pursuant to 35 U.S.C. § 311. Patent Owner Endotach LLC (“Endotach”) did not
`file a Preliminary Response. We have jurisdiction under 35 U.S.C. § 314.
`The standard for instituting an inter partes review is set forth in 35 U.S.C.
`§ 314(a), which provides:
`THRESHOLD—The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311 and any
`response filed under section 313 shows that there is a reasonable
`likelihood that the petitioner would prevail with respect to at least 1 of
`the claims challenged in the petition.
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`For the reasons set forth below, we conclude that Medtronic has shown that,
`under 35 U.S.C. § 314(a), there is a reasonable likelihood that it would prevail with
`respect to at least one of the challenged claims. We institute an inter partes review
`of claims 1, 2, 9, 10, and 13 of the ’417 patent.
`B. Related Matters
`Medtronic indicates that Endotach asserted the ’417 patent against it in
`Endotach LLC v. Medtronic, Inc. and Medtronic Vascular, Inc., No. 5:13-cv-
`03292-EJD (N.D. Cal.). Pet. 1. In its Mandatory Notices, Endotach identifies two
`other cases that may affect or be affected by this proceeding: Endotach LLC v.
`Cook Medical Inc., No. 1:13-cv-1135 (S.D. Ind.) and Endotach LLC v. W.L. Gore
`& Associates, Inc., No. 3:12-cv-00308 (N.D. Fla.). Paper 10, 2-3.
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`Patent 55,593,417
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`C. The ’4177 Patent (EEx. 1001)
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`The ’417 paatent relatees to an intraluminal mmedical deevice, suchh as an
`Ex. 1001,
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`endovasscular grafft or stent.
`3:45-48.
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`The patentt discussess U.S. Pat.
`No.
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`5,122,154 (Ex. 10008, “Rhoddes ’154”), also relatiing to an inntralumina
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`l graft. Exx.
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`1001, 2
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`:64-3:27. The ’417 ppatent statees the preseent graft ddevice “is cconstructedd in
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`accordaance with thhe teachinggs of my aaforementiooned patennt [Rhodes
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`’154], exccept
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`for the mmeans for fixedly holding it in place withhin the vesssel, duct, oor lumen,”
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`the “ancchoring meeans.” Id.
`at 5:10-17
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`FFigures 2, 33, 7, and 8 of the ’4177 patent arre reproducced below.
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` Id. at 4:4
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`7-52. Figuure
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`Figure 22 depicts aa portion off an endovaascular byppass graft.
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`3 depictts an enlargged view oof the portiion in Figuure 2 designnated as “FFIG. 3” wi
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`broken lines. Id. aat 4:53-55.. Figure 7 depicts annother embbodiment o
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`f a graft. IId.
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`at 4:65-67. Figure 8 depicts an enlarged sectional view taken along line 8-8 of
`Figure 7. Id. at 5:1-2.
`In Figure 2, the graft comprises tubular member 24 having a plurality of
`expandable, ring-like, stent members 26. Id. at 5:54-59. Each stent member 26
`comprises a plurality of links 30, where each link is joined to another link by joint
`32. Id. at 6:21-32. “In order to help hold or secure the graft in position in the
`artery (or lumen or duct) once the graft has been expanded,” the graft includes
`anchoring means comprising projections 40. Id. at 7:9-13. Figure 3 shows details
`of an embodiment of “arrow head” projections 40 on joint 32. Id. at 7:60-63. Each
`projection “includes a leading edge 42 defining the ‘tip’ of the ‘arrow-head,’”
`where “leading edge 42 extends upward at an acute angle to the exterior surface of
`the stent and terminates at the top surface 44 of the projection.” Id. at 7:63-67; see
`also Fig. 4. The projections also include trailing edges 48, 50, and 52, each of
`which “inclines upward in the direction of the blood flow to terminate at the top
`surface 44.” Id. at 8:2-6.
`In another embodiment, shown in Figures 7 and 8, projections 70 are
`“wedge” shaped. Id. at 8:54-56. Leading surface 72 defines “the ‘front face’ of
`the ‘wedge,’” and “extends upward at an acute angle to the exterior surface of the
`stent and terminates at the top surface 74.” Id. at 8:56-58. The projections also
`include “trailing surface 76 which inclines upward in the direction of the blood
`flow to terminate at the top surface 74 in a penetration edge 78,” and “are
`preferentially oriented at an acute angle to the direction of blood flow.” Id. at
`8:58-67.
`D. Illustrative Claim
`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,
`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,
`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,
`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,
`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 and emphasis added).
`E. Prior Art Relied Upon
`Medtronic relies upon the following prior art references:
`Lazarus, U.S. Pat. No. 5,104,399, issued Apr. 14, 1992 (“Lazarus”) (Ex. 1005);
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`Kornberg, U.S. Pat. No. 4,562,596, issued Jan. 7, 1986 (“Kornberg”) (Ex.1006);
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`Marin, U.S. Pat. No. 5,397,355, issued Mar. 14, 1995 (“Marin”) (Ex. 1007); and
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`Rhodes, U.S. Pat. No. 5,122,154, issued Jun. 16, 1992 (“Rhodes ’154”) (Ex.
`1008).
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`F. Alleged Grounds of Unpatentability
`Medtronic contends that the challenged claims of the ’417 patent are
`unpatentable under 35 U.S.C. § 102 and § 103 based on the following grounds.
`Pet. 8.
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`Reference(s)
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`Lazarus
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`Kornberg
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`Marin
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`Rhodes ’154 and Lazarus
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`Rhodes ’154 and Kornberg
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`Rhodes ’154 and Marin
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`II.
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`Basis
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`§ 102
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`§ 102
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`§ 102
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`§ 103
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`§ 103
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`§ 103
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`Claims Challenged
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`1, 2, 9, 10, and 13
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`1, 2, 9, 10, and 13
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`1, 2, 9, 10, and 13
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`1, 2, 9, 10, and 13
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`1, 2, 9, 10, and 13
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`1, 2, 9, 10, and 13
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`ANALYSIS
`A. Claim Construction
`Consistent with the statute and legislative history of the America Invents
`Act, the Board interprets claims using the “broadest reasonable construction in
`light of the specification of the patent in which [they] appear[].” 37 C.F.R.
`§ 42.100(b); see also Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756,
`48,766 (Aug. 14, 2012). There is a “heavy presumption” that a claim term carries
`its ordinary and customary meaning. CCS Fitness, Inc. v. Brunswick Corp., 288
`F.3d 1359, 1366 (Fed. Cir. 2002).
`Medtronic offers express constructions for the terms “projection,” “leading
`portion,” and “trailing portion,” recited in claim 1, as well as “stent” recited in
`claims 9, 10, and 13. Pet. 9-12. Those terms carry their ordinary and customary
`meaning and do not need further construction at this stage of the proceeding.
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`B. Anticipation by Kornberg
`Medtronic argues that Kornberg anticipates claims 1, 2, 9, 10, and 13. Pet.
`8, 19-22.
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`1. Kornberg (Ex. 1006)
`Kornberg describes a tubular graft comprising “a plurality of struts or stays
`equipped with hooks for rapid and secure attachment within the desired location of
`the damaged artery.” Ex. 1006, 2:15-19. Figures 1 and 2 of Kornberg are
`reproduced below.
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`Figure 1 depicts an aortic bifurcation graft equipped with a circumferential row of
`hooks 14 and a plurality of longitudinal struts 12. Id. at 2:23-27. Figure 2 depicts
`an enlarged view of the upper end of a single strut 12 with hook 14. Id. at 2:28-29.
`Kornberg states that graft 10 “must have support along its length, so that the
`blood flow does not dislodge it,” but the graft “is sufficiently flexible to be capable
`of conforming to the interior contour of the wall portion of the artery into which it
`is inserted.” Id. at 2:56-62. Graft 10 “is a generally cylindrical, hollow, bifurcated
`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
`instance, as shown in Figure 1, struts 12 run along the length of legs (10A and
`10B) of graft 10 and “assure proper orientation of the graft within the artery.” Id.
`at 2:62-68; 4:17-20. As described in Kornberg, “the number of circumferential
`located strengthening struts or ribs 12 attached or formed in the wall of the graft
`may vary from a minimum of four up to twelve or more, preferably eight.” Id. at
`3:1-5. Graft 10 also includes flexible ring 16 at the upper end of the graft. Id. at
`4:6-9.
`Hooks 14 are located at the upper end of each strut 12, and a “row of hooks
`14 forms a ring around the outer circumference of graft 10 and are oriented
`downwardly at an angle of about 10º˗45º C. with respect to the vertical.” Id. at
`3:60-65; see also 4:28-30 (stating that hook 14 is at an angle of about 30º in Figure
`2). As described in Kornberg, “[e]ach hook 14 has a barb 15 located at the lower
`end of the hook so as to inhibit upward movement which might tend to dislodge
`the graft after it is positioned and attached to the aorta wall.” Id. at 3:66-4:1.
`2. Analysis
`Medtronic contends that Kornberg discloses each and every element of
`claim 1, referring to annotated versions of Figures 1, 2, and 9 in Kornberg and
`disclosures in the reference, as well as a claim chart and a Declaration by Travis
`Rowe. Pet. 19-22, Appx. A2, pp. 5-9; Ex. 1003 ¶¶ 22-26. For example, Medtronic
`points to disclosure in Kornberg as corresponding to 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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`Elemennt in claim 1
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`sure in Koornberg
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`“anchorring meanss” comprisiing “plurall Hookss 14
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`projectiions”
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`Pet. 20, Appx. A22, pp. 5-7.
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`Inn relation tto the “leadding portioon” and “trrailing porttion” of thee projectioons
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`recited iin claim 1,, Medtronic provides annotatedd figures froom Kornb
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`annotateed Figure 22, reproducced below..
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`(shown preeviously),
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`Pet. 20. Annotateed Figure 22 depicts Fiigure 2 of KKornberg
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`with addded designnations inclluding “Leeading Porttion,” “Uppstream,” “
`Trailing
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`Portion,,” “Acute AAngle,” “DDownstreamm,” and ann arrow inddicating “FFluid Flow
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`(‘First DDirection’)).” Id.
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` Id.
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`of the tuubular memmber (strutts 12 and riing 16) in KKornberg’
`s graft 10.
`a “leading
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`as designaated
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`Accordiing to Meddtronic, eacch hook 144 includes a
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`fluid flow,, as recitedd in
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`in annottated Figurre 2, locateed in the uppstream dir
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`claim 1. Id. Meddtronic furthher contennds that eacch hook inccludes a “ttrailing
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`portion,,” as also ddesignated in annotated Figure 22, located
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`in the dowwnstream
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`MMedtronic ccontends thhat hooks 14 are locaated adjaceent to the oouter periphhery
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`direction of fluid flow, which includes a portion that is oriented to extend at an
`acute angle to the fluid flow, as also recited in claim 1. Id. at 20-21.
`In relation to the last “whereupon” clause in claim 1, Medtronic also
`contends, relying on the Rowe Declaration, that
`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). Medtronic also points us to Kornberg’s
`Abstract, which describes “struts having angled hooks with barbs at their upper
`ends, the upper ends of the struts extending beyond the upper end of the tubular
`material, thus allowing the graft to be securely attached to the inside of the aorta.”
`Ex. 1006, Abstract; Pet. Appx. A2, pp. 7-8.
`Based on the record before us, Medtronic reasonably identifies where
`Kornberg describes, expressly or inherently, every element of claim 1. Pet. 19-21,
`Appx. A2, pp. 5-8. We are persuaded that Medtronic has demonstrated that there
`is a reasonable likelihood that it would prevail on the ground that claim 1 is
`anticipated by Kornberg.
`In addition, Medtronic reasonably identifies where Kornberg describes the
`elements of dependent claims 2, 9, 10, and 13. Pet. 21-22, Appx. A2, pp. 8-9. In
`relation to claim 2, Medtronic contends that, in Kornberg, “at least one surface of
`the trailing portion is inclined upward in the first direction (‘fluid flow direction’)
`when the device (‘graft 10’) is placed in a vessel, duct, or lumen,” as depicted in
`annotated Figure 2 above. Pet. 21, Appx. A2, p. 8.
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`In relation to claims 9 and 10, Medtronic contends that Kornberg describes a
`graft comprising a tubular member (struts 12 and ring 16) that is an expandable
`stent, i.e., “longitudinal supporting and reinforcing members called struts 12
`running along the major axis of the cylindrical sleeve,” where ring 16
`“[f]unction[s] to keep the graft fully expanded.” Pet. 21-22, Appx. A2, p. 8; Ex.
`1006, 2:62-65, 6:35-37. Medtronic further points to where Kornberg describes
`ring 16 in a “compressed, or partially open state prior to positioning in the
`damaged artery,” and that “[o]nce in place, the ring will spring open and snug up
`against the walls of the artery covering the punctures in the arterial wall made by
`the hooks 14.” Pet. Appx. A2, pp. 8-9; Ex. 1006, 4:6-15. In relation to claim 13,
`Medtronic contends that Kornberg describes an endovascular graft (graft 10) that
`comprises a graft sleeve (“cylindrical, hollow, bifurcated sleeve”) that is coupled to
`the expandable stent (struts 12 and ring 16, as discussed above), where blood flow
`applies pressure to projections (hooks 14). Pet. 22, Appx. A2, p. 9; Ex. 1006, 2:62-
`65.
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`We are persuaded that Medtronic has demonstrated that there is a reasonable
`likelihood that it would prevail on the ground that dependent claims 2, 9, 10, and
`13 are anticipated by Kornberg.
`C. Obviousness over Rhodes ’154 and Kornberg
`Medtronic contends that claims 1, 2, 9, 10, and 13 would have been obvious
`over Rhodes ’154 and Kornberg. Pet. 8, 27-29. We discuss Kornberg above.
`1. Rhodes ’154 (Ex. 1008)
`Rhodes ’154 describes an endovascular graft. Figure 1 in Rhodes ’154 (Ex.
`1008) and Figure 1 in the ’417 patent (Ex. 1001) are reproduced below.
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`Figure 11 in Rhodees ’154 (topp) and Figuure 1 in thee ’417 pateent (bottomm) both deppict
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`a sectional view oof an arteryy with an exxpandable
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`intraluminnal vasculaar bypass ggraft.
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` Ex. 10008, 4:58-622; Ex. 10011, 4:46-50.
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`AAs stated inn the ’417 ppatent, Rhoodes ’154
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`expandaable sleevee (a tubularr member) having exxpandable pplural stentts, where
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`“[e]ach stent is a ggenerally rring-like mmember formmed a plurrality of intterconnectted
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`e links andd is mounteed about thhe peripherry of a surfface, e.g., iinner or ouuter,
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`of the slleeve at selected poinnts along thhe sleeve tto form resspective sppaced first
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`sleeve sections.” Ex. 1001, 2:64-3:20; Ex. 1008, 5:62-66. In addition, as stated in
`the ’417 patent, the graft in Rhodes ’154 “makes use of some anchoring means,
`e.g., small dome shaped projections, for aiding in the securement of the graft in
`place within the vessel, duct, or lumen,” although the anchoring means are
`“amenable to improvement insofar as graft retention is concerned.” Ex. 1001,
`3:21-26; see also Ex. 1008, 7:18-24 (describing a “plurality of protuberances 50
`projecting slightly outward from the outer surface of the graft . . . [that] help
`impact the graft into the arterial wall to maintain a fixed position therein . . . [and]
`are preferably located at the joints 34”).
`2. Analysis
`Medtronic contends that Rhodes ’154 discloses all elements of the
`challenged claims except “the specific orientation of the intraluminal medical
`device’s projections – that the projections be oriented to extend at an acute angle to
`the direction of fluid flow,” citing Rhodes ’154, the ’417 patent and its prosecution
`history, and the Rowe Declaration. Pet. 27-28, Appx. A5, pp. 19-24; see also Ex.
`1002, 48-49; Ex. 1003 ¶¶ 22, 23, 28. Medtronic relies on Kornberg as disclosing a
`relevant device “comprising projections (‘hooks 14’) where the trailing portion
`(‘downstream portions’) of each projection (‘hooks 14’) has at least one surface
`that is preferentially oriented to extend at an acute angle to the fluid flow
`direction.” Pet. 28, Appx. A5, pp. 20-21. Regarding dependent claim 2,
`Medtronic contends that Kornberg discloses at least one surface of the trailing
`portion of each projection (hook 14) as being inclined upward in the first direction
`(fluid flow direction). Id. at Pet. Appx. A5, pp. 22-23. Regarding dependent
`claims 9, 10, and 13, Medtronic reasonably points to where Rhodes ’154 and
`Kornberg each disclose the recited elements. Id. at Pet. Appx. A5, pp. 23-24.
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`Medtronic further contends that a person of ordinary skill in the art would
`have had reason to use the projections (hooks 14) of Kornberg with the device of
`Rhodes ’154 (in place of Rhodes ’154’s projections) “to provide an intraluminal
`medical device with improved anchoring capabilities for securing the device in
`place within a vessel, duct, or lumen,” and “to prevent migration of the
`intraluminal medical device,” citing a Declaration by Atul Gupta in support. Id. at
`28-29 (citing Ex. 1004 ¶¶ 30-33).
`Rhodes ’154 discloses the use of projections (protuberances 50), located at
`on the outer periphery of a tubular member at stent joints in a relevant device,
`where those protuberances act as “small pressure points” to help a graft “maintain
`a fixed position” in an artery wall. Ex. 1008, 7:18-26; Figures 8 and 9. Kornberg
`describes attaching a graft to the inside wall of an aorta using hooks 14, which
`“inhibit upward movement which might tend to dislodge the graft,” as discussed
`above. Ex. 1006, 3:60-4:1. Based on the record before us, we are persuaded that
`Medtronic reasonably contends that a person of ordinary skill in the art would have
`had reason to use the hooks disclosed in Kornberg in place of protuberances 50 in
`the device of Rhodes ’154.
`Medtronic has demonstrated that there is a reasonable likelihood that it
`would prevail on the ground that claims 1, 2, 9, 10, and 13 of the ’417 patent
`would have been obvious over Rhodes ’154 and Kornberg.
`D. Remaining Ground of Unpatentability
`In addition to the grounds of unpatentability discussed above, Medtronic
`also alleges other grounds with respect to the challenged claims. Upon review of
`those grounds, we conclude that they are redundant in light of the grounds on the
`basis of which we institute inter partes review of the same claims. We do not
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`authorize an inter partes review on those redundant grounds. See 37 C.F.R.
`§ 42.108(a).
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`III. CONCLUSION
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`For the foregoing reasons, we are persuaded that Medtronic has
`demonstrated that there is a reasonable likelihood that it would prevail on the
`grounds that Kornberg anticipates, and Rhodes ’154 and Kornberg rendered
`obvious, claims 1, 2, 9, 10, and 13 of the ’417 patent. The Board has not made a
`final determination on the patentability of the challenged claims.
`
`IV. ORDER
`
`For the reasons given, it is
`ORDERED that the Petition is granted with respect to the alleged
`
`ground, under 35 U.S.C. § 102, that Kornberg anticipates claims 1, 2, 9, 10, and 13
`of the ’417 patent;
`FURTHER ORDERED that the Petition is granted with respect to the
`alleged ground, under 35 U.S.C. § 103, that claims 1, 2, 9, 10, and 13 of the ’417
`patent would have been obvious over Rhodes ’154 and Kornberg;
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(a), inter
`partes review of the ʼ417 patent is hereby instituted commencing on the entry date
`of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is
`hereby given of the institution of a trial;
`
`FURTHER ORDERED that the other grounds presented in
`Medtronic’s Petition are denied, and no ground other than that specifically granted
`above is authorized for the inter partes review as to claims 1, 2, 9, 10, and 13; and
`
`FURTHER ORDERED that an initial conference call with the Board
`is scheduled for 11:00 AM Eastern Time on April 17, 2014. The parties are
`
`15
`
`
`
`
`
`Case IPR2014-00100
`Patent 5,593,417
`
`
`directed to the Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,765-66, for
`guidance in preparing for the initial conference call, and should be prepared to
`discuss any proposed changes to the Scheduling Order entered herewith and any
`motions the parties anticipate filing during the trial.
`
`
`
`PETITIONER:
`
`
`Jack Barufka
`Pillsbury Winthrop Shaw Pittman LLP
`barufka@pillsburylaw.com
`
`Ngai Zhang
`Pillsbury Winthrop Shaw Pittman LLP
`ngai.zhang@pillsburylaw.com
`
`
`
`
`
`PATENT OWNER:
`
`
`Matthew Phillips
`Renaissance IP Law Group LLP
`matthew.phillips@renaissanceiplaw.com
`
`Brett M. Pinkus
`Friedman, Suder & Cooke
`pinkus@fsclaw.com
`
`Jonathan T. Suder
`Friedman, Suder & Cooke
`jts@fsclaw.com
`
`
`16