IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`Trial Number: To Be Assigned
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` Attorney Docket No.: 058888-0000015
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`In the Inter Partes Review of:
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`U.S. Patent No. 5,593,417
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`Filed: November 27, 1995
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`Issued: January 14, 1997
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`Inventor: Rhodes, Valentine J.
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`Assignee: Rhodes, Valentine J.
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`Title: INTRAVASCULAR STENT WITH
`SECURE MOUNTING MEANS
`__________________________________________________________________
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Panel: To Be Assigned
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`PETITION FOR INTER PARTES REVIEW UNDER 37 C.F.R. § 42.100
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`TABLE OF CONTENTS
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`I. 
`
`II. 
`III. 
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`MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1) .......................... 1 
`A.  Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) ................................. 1 
`B.  Related Matters Under 37 C.F.R. § 42.8(b)(2) ........................................... 1 
`C.  Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ........................ 1 
`D.  Service Information Under 37 C.F.R. § 42.8(b)(4) .................................... 2 
`PAYMENT OF FEES UNDER 37 C.F.R. § 42.103 ....................................... 2 
`SUMMARY OF THE '417 PATENT.............................................................. 2 
`A.  Description of the Alleged Invention of the '417 Patent ............................ 2 
`B.  Summary of the Prosecution History of the '417 Patent ............................ 5 
`IV.  REQUIREMENTS FOR INTER PARTES REVIEW UNDER 37 C.F.R.
`§§ 42.104 ......................................................................................................... 7 
`A.  Grounds for Standing Under 37 C.F.R. § 42.104(a) .................................. 7 
`B.  Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested .................................................................................................... 8 
`C.  Claims for Which Inter Partes Review Is Requested Under 37 C.F.R
`§ 42.104(b)(1) ............................................................................................. 8 
`D.  The Specific Art and Statutory Ground(s) on Which the Challenge Is
`Based Under 37 C.F.R. § 42.104(b)(2) ...................................................... 8 
`E.  How the Challenged Claims Are to Be Construed Under 37 C.F.R.
`§ 42.104(b)(3) ............................................................................................. 9 
`1.  “projection” ......................................................................................... 10 
`2.  “leading portion” ................................................................................. 10 
`3.  “trailing portion” ................................................................................. 11 
`4.  “stent” .................................................................................................. 11 
`F.  How the Construed Claim(s) Are Unpatentable Under 37 C.F.R.
`§ 42.104(b)(4) ........................................................................................... 12 
`G.  Supporting Evidence Under 37 C.F.R. § 42.104(b)(5) ............................ 12 
`V.  DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`REVIEW IS REQUESTED UNDER 37 C.F.R. § 42.104(b) (4) .................. 12 
`A.  Claims 1, 2, 9, 10, and 13 are Anticipated Under 35 U.S.C. § 102(b) by
`Lazarus (Exh. 1005) ................................................................................. 15 
`i
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`B.  Claims 1, 2, 9, 10, and 13 are Anticipated Under 35 U.S.C. § 102(b) by
`U.S. Patent No. 4,562,596 to Kornberg (Exh. 1006) ............................... 19 
`C.  Claims 1, 2, 9, 10, and 13 are Anticipated Under 35 U.S.C. § 102(e) by
`U.S. Patent No. US 5,397,355 to Marin (Exh. 1007) ............................... 22 
`D.  Claims 1, 2, 9, 10, and 13 are Obvious Under 35 U.S.C. § 103(a) Over
`Rhodes '154 (Exh. 1008) In View of Lazarus .......................................... 25 
`E.  Claims 1, 2, 9, 10, and 13 are Obvious Under 35 U.S.C. § 103(a) Over
`Rhodes '154 In View of Kornberg ............................................................ 27 
`F.  Claims 1, 2, 9, 10, and 13 are Obvious Under 35 U.S.C. § 103(a) Over
`Rhodes '154 In View of Marin ................................................................. 29 
`VI.  CONCLUSION .............................................................................................. 31 
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`ii
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`Appendix of Exhibits (Exhibit List) for
`Inter Partes Review of U.S. Patent No. 5,593,417
`Exhibit Description
`U.S. Patent No. 5,593,417 to Rhodes
`File History for U.S. Patent No. 5,593,417
`Declaration of Travis Rowe
`Declaration of Atul Gupta
`U.S. Patent No. 5,104,399 to Lazarus
`U.S. Patent No. 4,562,596 to Kornberg
`U.S. Patent No. 5,397,355 to Marin
`U.S. Patent No. 5,122,154 to Rhodes
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`Exhibit No.
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`1008
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`iii
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`Inter partes review is respectfully requested for claims 1, 2, 9, 10, and 13 of
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`U.S. Patent No. 5,593,417 (“the '417 patent”) (Exh. 1001).
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`I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8(a)(1)
`The following mandatory notices are provided as part of this Petition.
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`A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`Medtronic, Inc. and Medtronic Vascular, Inc. (collectively “Petitioner”) are
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`the real parties-in-interest.
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`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`The '417 patent is presently the subject of litigation brought by the exclusive
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`licensee against Petitioner in the U.S. District Court for the District of California
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`San Jose Division in a case titled Endotach LLC v. Medtronic, Inc., et al., No.
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`5:13-cv-03292-EJD.
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`C. Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Petitioner provides the following designation of counsel:
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`Lead Counsel
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`Back-Up Counsel
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`Jack Barufka (Reg. No. 37,087)
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`Ngai Zhang (Reg. No. 65,473)
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`PILLSBURY WINTHROP SHAW
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`PILLSBURY WINTHROP SHAW
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`PITTMAN LLP
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`PITTMAN LLP
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`Postal and Hand Delivery Address
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`Postal and Hand Delivery Address
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`1650 Tysons Boulevard, Suite 1400
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`1650 Tysons Boulevard, Suite 1400
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`McLean, Virginia 22102
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`McLean, Virginia 22102
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`Telephone: 703.770.7712
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`Telephone: 703.770.7532
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`Facsimile: 703.906.2500
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`Facsimile: 703.770.7901
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`Email: jack.barufka@pillsburylaw.com
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`Email: ngai.zhang@pillsburylaw.com
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`D.
`Service of any documents via hand-delivery may be made at the postal
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`Service Information Under 37 C.F.R. § 42.8(b)(4)
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`mailing address of the respective lead or back-up counsel designated above with
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`courtesy email copies to the email addresses and docket_ip@pillsburylaw.com.
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`II.
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`PAYMENT OF FEES UNDER 37 C.F.R. § 42.103
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`The undersigned authorizes the Office to charge Deposit Account No.
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`033975 for the fee set forth in 37 C.F.R. § 42.15(a), or any other applicable fees,
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`for this Petition for inter partes review. The undersigned further authorizes
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`payment for any additional fees that might be due in connection with this Petition
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`to be charged to the above-referenced Deposit Account.
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`III. SUMMARY OF THE '417 PATENT
`A. Description of the Alleged Invention of the '417 Patent
`The alleged invention of the '417 patent relates generally to intraluminal
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`medical devices (e.g., grafts or stents) having anchoring means for securing the
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`devices in vessels, ducts, or lumens of living beings. Exh. 1001, 1:5-10. The '417
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`patent states that numerous grafts and stents were known in the prior art. Id. at
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`2
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`2:15-63. These stents and grafts were inserted into blood vessels and expanded in
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`revascularization procedures to preclude restenosis. Id. at 1:64 to 2:17. The '417
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`patent also explains that another useful area of stent application was percutaneous
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`angioplasty of Takayasu arteritis and neurofibromatosis arterial stenosis. Id. at
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`2:17-21.
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`The alleged invention of the '417 patent addresses in particular a perceived
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`shortcoming in prior art grafts. Specifically, the '417 patent allegedly addresses the
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`manner in which grafts were anchored within the body duct, vessel or lumen. The
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`'417 patent specification points to the patentee’s own prior U.S. Patent No.
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`5,122,154 (“the '154 patent”), which was of the same construction of the '417
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`patent, except for the particular anchoring means for securing the graft in place. In
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`particular, the '417 patent specification states that:
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`The graft of my aforementioned patent 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. While such anchoring means are believed
`effective for their intended purpose, they never the less appear
`to be amenable to improvement insofar as graft retention is
`concerned.
`Id. at 3:21-27.
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`3
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`Aside from the specific anchoring means employed by the '417 patent, the
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`patentee acknowledged that the alleged invention was otherwise the same as the
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`prior art U.S. Patent No. 5,122,1541:
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`The graft device [] is constructed in accordance with the
`teachings of my aforementioned patent, except for the means
`for fixedly holding it in place within the vessel, duct, or lumen.
`In this regard the subject invention makes use of anchoring
`means, to be described later, which offer an improvement in
`retention over
`the
`“protuberances” disclosed
`in my
`aforementioned patent.
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`Id. at 5:10-17.
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`In contrast to the above-mentioned dome shaped projections, the '417 patent
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`alleges that the unique or patentable feature of the alleged invention is the specific
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`angle or orientation of the projections. In particular, the '417 patent explains that
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`the essence of the alleged invention is to provide projections that are oriented at an
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`acute angle to the direction of blood flow. It was believed that this orientation
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`would help prevent migration of the graft:
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`1 U.S. Patent No. 5,122,154 was granted on June 16, 1992, more than one year
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`prior to the earliest priority date of the '417 patent and is thus prior art under 35
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`USC § 102(b) against the '417 patent.
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`4
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`It should be pointed out that anchoring projections constructed
`in accordance with this invention can take numerous other
`shapes and sizes than those shown herein. In this regard, the
`projections need not include sharp edges and/or planar surfaces
`or points, and can be rounded, domed, or any other suitable
`shape, so long as they are preferentially oriented to project or
`extend at some acute [] angle to the direction of fluid flow,
`whereupon the force applied to them by the fluid flowing
`through the vessel, duct, or lumen, in which the device to be
`secured by them flows produces on each of them a force
`component extending in the direction of the fluid flow and a
`force component extending perpendicularly to that direction. As
`discussed above this action causes the projections to tightly
`engage (and not necessarily penetrate) the interior of the wall of
`the vessel, duct, or lumen to fixedly secure the device in place
`against migration.
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`Id. at 9:1-17.
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`Summary of the Prosecution History of the '417 Patent
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`B.
`Referring to the prosecution history of the '417 patent (Exh. 1002), the '417
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`patent was filed as U.S. App. Serial No. 08/562,727 on Nov. 27, 1995. See Exh.
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`1002, Application as Filed (paper 1). The '417 patent does not claim priority to any
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`earlier filed applications.
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`Application claims 1 and 9-15 were rejected under 35 U.S.C. § 102(b) as
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`being anticipated by the patentee’s own '154 patent. See id. at First Office Action
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`5
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`(paper 2), pg. 2. In response to the First Office Action, patentee filed an
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`amendment on May 17, 1996 that, among other things, added limitations
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`concerning the projections of the claimed anchoring means. Id. at Amendment
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`(paper 3). For example, claim 1 was amended to additionally recite that each of the
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`projections has a trailing portion located in the downstream direction thereof,
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`where the trailing portion includes at least one surface preferentially oriented to
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`extend at an acute angle to a first direction in which the body fluid flows. Id. at
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`paper 3, pg. 2.
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`In addition, the patentee admitted that the patentee’s own '154 patent
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`“discloses a similar device with anchoring means to secure it to the wall of the
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`vessel, duct, or lumen in which [the device] is located.” Id. at paper 3, pg. 4. The
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`patentee further explained that while the '154 patent taught projections or
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`protuberances that project outward from the outer surface of a graft to secure the
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`graft in place within an artery, the '154 patent did not disclose the essence of the
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`alleged invention – i.e., projections that have a trailing portion with at least one
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`surface preferentially oriented to extend at an acute angle to the direction of the
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`fluid flow. Specifically, the patentee states that:
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`[T]he anchoring means of applicant’s earlier patent are
`protuberances which are disclosed . . . as projecting slightly out
`of the outer surface of the graft to act as small pressure points
`that help impact the graft into the artery wall to hold it in place.
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`
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`6
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`There isn’t any disclosure . . . that the projections include a
`trailing portion having at least one surface (e.g., a trailing
`surface) which is preferentially oriented to extend at an acute
`angle to the direction of the fluid flow.
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`Id. at paper 3, pgs. 4-5.
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`The Examiner subsequently issued a Notice of Allowability on July 29, 1996
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`that included a few Examiner amendments to the claim language. Id. at Notice of
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`Allowability (paper 6).
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`IV. REQUIREMENTS FOR INTER PARTES REVIEW UNDER 37 C.F.R.
`§§ 42.104
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`As set forth below and pursuant to 37 C.F.R. § 42.104, each requirement for
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`inter partes review of the '417 patent is satisfied.
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`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner hereby certifies that the '417 patent is available for inter partes
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`review and that the Petitioner is not barred or estopped from requesting inter partes
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`review challenging the claims of the '417 patent on the grounds identified herein.
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`More particularly, Petitioner certifies that: (1) Petitioner is not the owner of the
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`'417 patent; (2) Petitioner has not filed a civil action challenging the validity of a
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`claim of the '417 patent; (3) this Petition is filed less than one year after the date on
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`which the Petitioner, the Petitioner’s real party-in-interest, or a privy of the
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`Petitioner was served with a complaint alleging infringement of the '417 patent; (4)
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`the estoppel provisions of 35 U.S.C. § 315(e)(1) do not prohibit this inter partes
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`7
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`review; and (5) this Petition is filed after the later of (a) the date that is nine months
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`after the date of the grant of the '417 patent or (b) the date of termination of any
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`post-grant review of the '417 patent.
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`B.
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`Identification of Challenge Under 37 C.F.R. § 42.104(b) and Relief
`Requested
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`The precise relief requested by Petitioner is that claims 1, 2, 9, 10, and 13
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`(“the challenged claims”) of the '417 patent be found unpatentable.
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`C. Claims for Which Inter Partes Review Is Requested Under 37
`C.F.R § 42.104(b)(1)
`Inter partes review of the challenged claims of the '417 patent is requested.
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`D. The Specific Art and Statutory Ground(s) on Which the
`Challenge Is Based Under 37 C.F.R. § 42.104(b)(2)
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`Inter partes review of the challenged claims is requested in view of the
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`following references and specific grounds for rejection under 35 U.S.C. §§ 102 and
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`103: (1) the challenged claims are anticipated by U.S. Patent No. 5,104,399 to
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`Lazarus (“Lazarus”); (2) the challenged claims are anticipated by U.S. Patent No.
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`4,562,596 to Kornberg (“Kornberg”); (3) the challenged claims are anticipated by
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`U.S. Patent No. 5,397,355 to Marin (“Marin”); (4) the challenged claims are
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`obvious over U.S. Patent No. 5,122,154 to Rhodes (“Rhodes '154”) in view of
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`Lazarus; (5) the challenged claims are obvious over Rhodes '154 in view of
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`Kornberg; and (6) the challenged claims are obvious over Rhodes '154 in view of
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`Marin.
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`8
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`Each reference and grounds listed above establishes a reasonable likelihood
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`that Petitioner will prevail on at least one claim and thus this petition for inter
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`partes review should be granted.
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`E. How the Challenged Claims Are to Be Construed Under 37 C.F.R.
`§ 42.104(b)(3)
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`Petitioner notes that a claim is given the “broadest reasonable construction in
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`light of the specification” in inter partes review. See 37 C.F.R. § 42.100(b).2
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`Petitioner’s claim construction herein should not be taken to mean that Petitioner
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`agrees or admits that any claim element of the challenged claims should receive the
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`benefits of the doctrine of equivalents, that Petitioner is precluded from
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`propounding alternative claim constructions, or that Petitioner agrees or believes
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`that the claims at issue are amendable to a meaningful construction or satisfy the
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`requirements of 35 U.S.C. § 112. All claim terms not specifically addressed in this
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`2 Other forums, such as U.S. District Courts, require different standards of proof
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`and utilize different claim interpretation rules that are not applied by, or
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`applicable to, the Patent Office for inter partes reviews. Therefore, any
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`interpretation or construction of the challenged claims in this Petition is made
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`solely pursuant to the broadest reasonable construction rule applicable to this
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`Petition, and shall not be viewed as constituting, in whole or in part, Petitioner’s
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`interpretation or construction under any other forum’s rules or standards.
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`9
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`section have been accorded their broadest reasonable interpretation in light of the
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`patent specification.
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` “projection”
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`1.
`Claims 1, 3-6, 8, and 13 include the term “projection.” The written
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`description of the '417 patent describes that a projection constructed in accordance
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`with the alleged invention “can take numerous other shapes and sizes than those
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`shown herein. . . . [T]he projection need not include sharp edges and/or planar
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`surfaces or points, and can be rounded, domed, or any other suitable shape, so long
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`as they are preferentially oriented to project or extend at some acute [] angle to the
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`direction of fluid flow.” Exh. 1001, 9:1-8. In light of the written description, the
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`broadest reasonable interpretation of the term “projection” is any structure that is
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`arranged to extend out from a surface at an acute angle to the the direction of fluid
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`flow.
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`“leading portion”
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`2.
`Claim 1 includes the term “leading portion.” The written description of the
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`'417 patent describes an edge of each projection 40 that is located in the upstream
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`direction of the fluid flow (relative to the trailing edges 48, 50, and 52 of the
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`respective projection 40) as the leading edge 42. Id. at 7:63 to 8:4. The written
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`description further describes a surface of each projection 70 that is located in the
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`upstream direction of the fluid flow (relative to the trailing surface 76 of the
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`
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`10
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`

`

`
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`respective projection 70) as the leading surface 72. Id. at 8:54-64. In light of the
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`written description, the term “leading portion” is a portion of the projection that is
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`located in the upstream direction of the fluid flow.
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`“trailing portion”
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`3.
`Claim 1 includes the term “trailing portion.” The written description of the
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`'417 patent describes edges of each projection 40 that is located in the downstream
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`direction of the fluid flow (relative to the leading edge 42 of the respective
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`projection 40) as the trailing edges 48, 50, and 52. Id. at 7:63 to 8:4. The written
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`description further describes a surface of each projection 70 that is located in the
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`downstream direction of the fluid flow (relative to the leading surface 72 of the
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`respective projection 70) as the trailing surface 76. Id. at 8:54-64. In light of the
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`written description, the broadest reasonable interpretation of the term “trailing
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`portion” is a portion of the projection that is located in the downstream direction of
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`the fluid flow relative to the leading portion.
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`“stent”
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`4.
`Claims 9, 10, and 13 include the term “stent.” The written description of the
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`'417 patent uses the term “stent members 26” and “stents 26” interchangeably with
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`one another. See id. at 6:21-26, 6:55-64, 7:2-7. As well known in the art, and as
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`supported by the '417 patent specification, a stent is a structure that provides
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`structural support (e.g., the stent is “the means for holding or retaining the sleeve
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`
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`11
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`

`
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`24 in any desired expanded state”). Id. at 6:21-22. In light of the written
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`description, the broadest reasonable interpretation of the term “stent” is any
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`structure that can provide structural support (e.g., for a graft sleeve, a blood vessel,
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`etc.).
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`F. How the Construed Claim(s) Are Unpatentable Under 37 C.F.R.
`§ 42.104(b)(4)
`
`An explanation of how construed claims 1, 2, 9, 10, and 13 of the '417 patent
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`are unpatentable under
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`the statutory grounds
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`identified above,
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`including
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`identification of where each element of the claim is found in the prior art patents or
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`printed publications, is provided in Section V and in Claim Charts (or Appendices)
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`A1-A6.
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`Supporting Evidence Under 37 C.F.R. § 42.104(b)(5)
`
`G.
`The exhibit numbers of the supporting evidence relied upon to support the
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`challenge and the relevance of the evidence to the challenge, including
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`identification of specific portions of the evidence that support the challenge, are
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`provided below in Section V and in Claim Charts (or Appendices) A1-A6.
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`V. DETAILED EXPLANATION OF PERTINENCE AND MANNER OF
`APPLYING CITED PRIOR ART TO EVERY CLAIM FOR WHICH
`REVIEW IS REQUESTED UNDER 37 C.F.R. § 42.104(b) (4)
`
`Claims 1, 2, 9, 10, and 13 of the '417 patent (“the challenged claims”) are
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`unpatentable because of one or more of the following grounds: (i) the challenged
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`claims are anticipated under 35 U.S.C. § 102(b) by U.S. Patent No. 5,104,399 to
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`
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`12
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`
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`Lazarus (“Lazarus”); (ii) the challenged claims are anticipated under 35 U.S.C.
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`§ 102(b) by U.S. Patent No. 4,562,596 to Kornberg (“Kornberg”); (iii) the
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`challenged claims are anticipated under 35 U.S.C. § 102(e) by U.S. Patent No.
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`5,397,355 to Marin (“Marin”); (iv) the challenged claims are obvious under
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`35 U.S.C. § 103(a) over U.S. Patent No. 5,122,154 to Rhodes (“Rhodes '154”) in
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`view of Lazarus; (v) the challenged claims are obvious under 35 U.S.C. § 103(a)
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`over Rhodes '154 in view of Kornberg; and (vi) the challenged claims are obvious
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`under 35 U.S.C. § 103(a) over Rhodes '154 in view of Marin.
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`With respect to the obviousness challenges under 35 U.S.C. § 103(a), as
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`clarified by the Supreme Court in KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398
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`(2007), Petitioner notes that purported inventions arising from ordinary innovation,
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`ordinary skill, or common sense should not be patentable. Id. at 400, 403-04,
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`418-22, 427-428. That is, “the combination of familiar elements according to
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`known methods is likely to be obvious when it does no more than yield predictable
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`results.” Id. at 416.
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`Of special relevance to the obviousness challenges is Rhodes '154 (or the
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`154 patent). In particular, as detailed in Section III above, the patentee made
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`numerous statements in the '417 patent specification and during prosecution
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`admitting that the alleged inventive intraluminal medical device of the '417 patent
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`was otherwise the same as the intraluminal medical device of the '154 patent
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`
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`13
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`
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`except for the specific means of the device for fixedly holding the device in place
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`within a vessel, duct, or lumen. Exh. 1001, 5:10-17; see also id. at 3:21-27, 9:1-17,
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`and Exh. 1002, paper 3, pg. 4. In other words, the alleged novelty of the '417 patent
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`over the prior art '154 patent is the specific orientation of the device’s projections –
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`that the projections be oriented to extend at an acute angle to the direction of fluid
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`flow. Id.; see also Comparison Chart below.
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`Comparison of the '154 Patent and
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`the '417 Patent
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`Figure 1 of the '154 patent
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` Figure 1 of the '417 patent
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`Figure 8 of the '154 patent
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`Figure 2 of the '417 patent
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`Nevertheless, as described herein, projections of intraluminal medical
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`devices (e.g., graft or stent devices) that are preferentially oriented to extend at an
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`acute angle to the direction of fluid flow were well known in the prior art for the
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`14
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`purpose of securing the devices in place within a vessel, duct, or lumen of a living
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`being.
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`As shown below, the alleged invention of the '417 patent is clearly
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`anticipated by several prior art references that were not considered by the U.S.
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`Patent and Trademark Office when deciding to grant the ‘417 patent. Moreover, as
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`also shown below, the '417 patent is obvious over the patentee’s own prior '154
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`patent mentioned above when viewed in light of several prior art references not
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`considered by the U.S. Patent and Trademark Office when deciding to grant the
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`'417 patent.
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`A. Claims 1, 2, 9, 10, and 13 are Anticipated Under 35 U.S.C.
`§ 102(b) by Lazarus (Exh. 1005)
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`Lazarus, which discloses an intraluminal medical device for securement
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`within a vessel, duct, or lumen of a living being, was filed on March 9, 1988, and
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`issued on April 14, 1992, and thus qualifies as prior art under § 102(b). Exh. 1005,
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`1:19-22. While Lazarus was not cited during prosecution of the '417 patent, related
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`U.S. Patent No. 5,397,345 to Lazarus (“Lazarus II”) was considered but not
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`applied by the Examiner during prosecution. The claim chart attached as Appendix
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`A1 details how each element recited in claims 1, 2, 9, 10, and 13 is anticipated by
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`Lazarus.
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`For example, annotated Figures 2, 3, 6, and 7 of Lazarus below illustrate an
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`intraluminal balloon-expanded medical device, a tubular member and anchoring
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`15
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`means of the intraluminal balloon-expanded medical device, and cross-sectional
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`views of the intraluminal balloon-expanded medical device being placed within a
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`vessel, duct, or lumen of a living being, respectively.
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`In particular, among other features shown by annotated Figures 2, 3, 6, 7
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`above, Lazarus discloses an intraluminal balloon-expanded medical device (“graft
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`12”) comprising a tubular member (“securing ring 16” (which is also referred to as
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`staple 16)) and anchoring means (“wall engaging members 70”). See also id. at
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`5:4-39. The anchoring means (“wall engaging members 70”) are located adjacent
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`the outer periphery of the tubular member (“securing ring 16”), and comprise
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`plural projections (i.e., the wall engaging members 70 are projections having
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`pointed ends 71) arranged for engagement with the interior surface of a vessel,
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`duct, or lumen of a living being. See annotated Fig. 3 of Lazarus above; see also
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`16
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`Exh. 1005, 5:61-63.
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`As further shown by annotated Figures 3 and 6 of Lazarus below, each of the
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`projections (“wall engaging members 70”) has a leading portion in the form of the
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`upstream portion of each wall engaging member 70 that is located in the upstream
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`direction of the fluid flow and a trailing portion in the form of the downstream
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`portion of each wall engaging member 70 that is located in the downstream
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`direction thereof. See also Exh. 1005, 5:47-51.
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`
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`In addition, the trailing portion of each projection (“wall engaging member
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`70”) comprises at least one surface that is preferentially oriented to extend at an
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`acute angle to a first direction (“fluid flow direction 100”). See annotated Figs. 3
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`and 6 of Lazarus above; see also Exh. 1005, 5:47-51.
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`Furthermore, force applied to the balloon-expanded tubular member
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`(“securing ring 16”) of Lazarus by fluid flowing through the interior passageway
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`thereof inherently produces on each of the projections (“wall engaging members
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`70”) a force component that causes at least one surface of the trailing portion to
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`17
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`tightly engage the interior surface of the vessel, duct, or lumen to fixedly secure
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`the device (“graft 12”) in place. Exh. 1005, 10:1-14 (“After emplacement, it can be
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`seen that the pressure of the lumen fluid, for example, blood forces the graft 12
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`against the lumen interior surface 154, helping to hold the graft 12 in its place. . . .
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`That is, the internal pressure of the fluid within the lumen 90 holds the graft 12 in
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`place and assists the [securing rings] 16 and 17 in preventing leakage at both ends
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`of the graft 12.”).
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`With respect to dependent claims 2, 9, 10, and 13 of the '417 patent,
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`annotated Figures 3 and 6 of Lazarus above show that the at least one surface of
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`the trailing portion is inclined upward in the first direction (“fluid flow direction
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`100”) when the device (“graft 12”) is placed in a vessel, duct, or lumen (claim 2).
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`Annotated Figures 3 and 6 of Lazarus above further show that the tubular member
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`(“securing ring 16”) of Lazarus is a stent having support members 60 (claim 9), see
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`also Exh. 1005, 5:4-23, and that the stent (“securing ring 16”) is expandable from a
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`contracted state (Fig. 6) to an expanded state (Fig. 7), where the anchoring means
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`(“wall engaging members 70”) engage the interior surface of the vessel, duct, or
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`lumen when the stent (“securing ring 16”) is in the expanded state to secure the
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`device (“graft 12”) in place (claim 10). See also id. at 9:38.42. In addition,
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`Lazarus discloses that the device (“graft 12”) is an endovascular graft that further
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`comprises a graft sleeve (“circumferential bifolds 50”), where the graft sleeve
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`18
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`(“circumferential bifolds 50”) is coupled to the stent (“securing ring 16”), and has
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`an outer surface and inner passageway through which the body fluid (e.g., blood)
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`flows in the first direction (“fluid flow direction 100”) to apply the force (e.g.,
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`from the fluid flowing through the tubular member) to the projections (“wall
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`engaging members 70”) (claim 13). See id. at 4:50-58; see also annotated Fig. 2 of
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`Lazarus above.
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`B. Claims 1, 2, 9, 10, and 13 are Anticipated Under 35 U.S.C.
`§ 102(b) by U.S. Patent No. 4,562,596 to Kornberg (Exh. 1006)
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`Kornberg was filed on April 25, 1984, and issued on January 7, 1986, and
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`thus qualifies as prior art under § 102(b). Kornberg was not cited during
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`prosecution of the '417 patent even though Kornberg describes an intraluminal
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`medical device for securement within a vessel, duct, or lumen of a living being.
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`Exh. 1006, Abstract. The claim chart attached as Appendix A2 details how each
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`element recited in claims 1, 2, 9, 10, and 13 is anticipated by Kornberg.
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`For example, annotated Figures 1, 2, and 9 of Kornberg below illustrate an
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`intraluminal manually-anchored medical device, anchoring means of
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`the
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`intraluminal manually-anchored medical device, and a view of the intraluminal
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`medical device manually anchored in place within a vessel, duct, or lumen of a
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`living being, respectively.
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`19
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`Specifically, among other features shown by annotated Figures 1, 2, and 9
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`above, Kornberg discloses an intraluminal manually-anchored medical device
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`(“graft 10”) comprising a tubular member (“struts 12 and ring 16”) and anchoring
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`means (“hooks 14”). See also id. at Abstract, 2:62-65, 3:60-65. The anchoring
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`means (“hooks 14”) are located adjacent the outer periphery of the tubular member
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`(“struts 12 and ring 16”), and comprise plural projections (“plural hooks 14”)
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`arranged for engagement with the interior surface of a vessel, duct, or lumen of a
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`living being. See annotated Figs. 1, 2, and 9 of Kornberg above; see also Exh.
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`1006, Abstract, 3:60-65, 4:6-9, 4:28-36. Each of the projections (“hooks 14”) has a
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`leading portion in the form of the upstream portion of each hook 14 that is located
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`in the upstream direction of the fluid flow and a trailing portion in the form of the
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`downstream portion of each hook 14 that is located in the downstream direction
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`thereof. See annotated Figs. 1, 2, and 9 of Kornberg above. The trailing portion of
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`each projection (“hook 14”) comprises at least one surface that is preferentially
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`20
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`oriented to extend at an acute angle to a first direction (“fluid flow direction”). See
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`annotated Figs. 1, 2, and 9 of Kornberg above; see Exh. 1006, 3:62-67.
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`Furthermore, force