`
`FOR THE WESTERN DISTRICT OF TEXAS
`
`WACO DIVISION
`
`TMT SYSTEMS, INC.,
`
`Plaintiff,
`
`V.
`
`MEDTRONIC, INC.,
`
`Defendant.
`
`Civil Action No. 6:20-cv-973-ADA
`
`Redacted Version
`
`DEFENDANT MEDTRONIC, INC.’S
`PRELIMINARY INVALIDITY CONTENTIONS
`
`MEDTRONIC 1151
`
`MEDTRONIC 1151
`
`
`
`TABLE OF CONTENTS
`
`
`
`Page(s)
`
`V.
`
`I.
`II.
`III.
`
`Introduction ........................................................................................................................1
`Reservations........................................................................................................................2
`Patent-In-Suit .....................................................................................................................6
`A.
`U.S. Patent No. 7,101,393........................................................................................6
`1.
`Priority Date of the ’393 patent ...................................................................6
`2.
`Asserted Claims of the ’393 patent ..............................................................7
`IV. General comments applicable to the ’393 patent ............................................................9
`A.
`General Reasons to Modify, Extend, or Combine Prior Art References .................9
`Identification of prior art ................................................................................................10
`A.
`Prior Art Patents / Patent Applications ..................................................................11
`B.
`Additional Prior Art References ............................................................................12
`C.
`Product Prior Art Under 35 U.S.C. §§ 102(a) and (b) ...........................................24
`D.
`Prior Art Under 35 U.S.C. § 102(g) Based on TMT’s Apparent
`Interpretation, Application and/or Construction of the Asserted Claims ..............25
`VI. Claim charts .....................................................................................................................26
`VII. Disclosures of Invalidity ..................................................................................................26
`A.
`Disclosure of Invalidity due to Anticipation ..........................................................26
`B.
`Disclosure of Invalidity due to Obviousness .........................................................28
`1.
`The Claimed Concepts Were Known ........................................................29
`2.
`Obviousness Combinations ........................................................................44
`3.
`Reasons to Modify, Extend, or Combine the Prior Art References ...........50
`4.
`No Objective Indicia of Non-Obviousness ................................................63
`VIII. Contentions under 35 U.S.C. § 112 .................................................................................64
`A.
`Lack of Written Description ..................................................................................65
`B.
`Enablement ............................................................................................................66
`
`
`
`
`
`i
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to the Court’s Order Governing Proceedings and consistent with the parties’
`
`respective proposed Order Governing Proceedings and Scheduling Order (D.I. 25-1 at 7; D.I. 25-
`
`2 at 7), Defendant Medtronic Inc. (“Medtronic” or “Defendant”) hereby serves its Preliminary
`
`Invalidity Contentions1 (“Preliminary Invalidity Contentions”) with respect to the asserted claims
`
`of U.S. Patent No. 7,101,393 (“the ’393 patent”) identified by TMT Systems., Inc. (“TMT” or
`
`“Plaintiff”) in TMT’s Preliminary Infringement Contentions, served on February 5, 2021
`
`(“Preliminary Infringement Contentions”).
`
`In its Preliminary Infringement Contentions, TMT has asserted claims 1, 2, 4, 10, 11, and
`
`26 of the ’393 patent against Medtronic. With respect to each asserted claim and based on its
`
`investigation to date, Medtronic: (a) identifies each item of prior art that anticipates each asserted
`
`claim or renders it obvious; (b) specifies whether each such item of prior art anticipates each
`
`asserted claim or renders it obvious, and if it renders it obvious, explains why the prior art
`
`renders the asserted claim obvious and identifies any combinations of prior art showing
`
`obviousness; (c) submits claim charts specifically identifying where and how in each item of
`
`prior art each limitation of each asserted claim is found2; and (d) identifies any grounds based on
`
`indefiniteness or lack of written description under 35 U.S.C. § 112.
`
`
`1 Defendant Medtronic, Inc. has filed a Motion to Dismiss the Amended Complaint under Rule
`12(b)(3) [D.I. 22] and a renewed contingent motion to transfer venue to the U.S. District Court
`for the Northern District of California [D.I. 23]. Medtronic does not believe that any further
`proceedings in this case should occur until those motions have been decided. By serving these
`Preliminary Invalidity Contentions, Medtronic does not waive any of its objections to proceeding
`in this venue and preserves all rights to seek a stay of later proceedings pending resolution of the
`venue-related motions.
`2 These Preliminary Invalidity Contentions cite to the pre-AIA versions of 35 U.S.C. §§ 101,
`102, 103, and 112.
`
`
`
`1
`
`
`
`
`
`II.
`
`RESERVATIONS
`
`Consistent with Footnote 7 of the Court’s Order Governing Proceedings and Footnote 10
`
`in the parties’ respective proposed Order Governing Proceedings and Scheduling Order (D.I. 25-
`
`1 at 7; D.I. 25-2 at 7), Medtronic reserves the right to further amend and/or supplement these
`
`Preliminary Invalidity Contentions.
`
`The information and documents that Medtronic produces are provisional and subject to
`
`revision. Medtronic expressly reserves the right to amend these disclosures should TMT provide
`
`any information that it failed to provide in its Preliminary Infringement Contentions, or should
`
`TMT amend its Preliminary Infringement Contentions in any way. Further, because discovery
`
`does not start until June 30, 2021 (see D.I. 25-1 at 7; D.I. 25-2 at 7), Medtronic reserves the right
`
`to revise, amend, and/or supplement the information provided herein, including identifying and
`
`relying on additional references, should Medtronic’s further search and analysis yield additional
`
`information or references, consistent with the Local Rules, the Federal Rules of Civil Procedure,
`
`and the Court’s Order Governing Proceedings – Patent Case, including any further information
`
`or references revealed by any third party subpoenas that cannot be served until fact discovery
`
`begins. Moreover, Medtronic reserves the right to revise its ultimate contentions concerning the
`
`invalidity of the asserted claims, which may change depending upon the Court’s construction of
`
`the asserted claims, any evidence or findings as to the priority or invention date of the asserted
`
`claims, and/or positions that TMT or its expert witness(es) may take concerning claim
`
`construction, infringement, and/or invalidity issues.
`
`Prior art not included in this disclosure, whether known or unknown to Medtronic, may
`
`become relevant. In particular, Medtronic is currently unaware of the extent, if any, to which
`
`TMT will contend that limitations of the asserted claims are not disclosed in the prior art
`
`identified by Medtronic, or will contend that any of the identified references do not qualify as
`
`
`
`2
`
`
`
`
`
`prior art. To the extent that such issues arise, Medtronic reserves the right to identify additional
`
`teachings in the same references or in other references that anticipate or would have made the
`
`addition of the allegedly missing limitation to the claimed device obvious, consistent with the
`
`Court’s Order Governing Proceedings – Patent Case. In providing these contentions, Medtronic
`
`has relied on the contents of TMT’s Preliminary Infringement Contentions
`
`Medtronic’s claim charts in Exhibits A through P cite to particular teachings and
`
`disclosures of the prior art as applied to features of the asserted claims. However, persons
`
`having ordinary skill in the art may view an item of prior art generally in the context of other
`
`publications, literature, products, and understanding that was available in the art. Accordingly,
`
`the cited portions are only examples, and Medtronic reserves the right to rely on uncited portions
`
`of the prior art references and on other publications and expert testimony as aids in
`
`understanding and interpreting the cited portions, as providing context thereto, and as additional
`
`evidence that a claim limitation is known or disclosed. Citations to figures are inclusive of all
`
`discussion of those figures. Medtronic further reserves the right to rely on uncited portions of
`
`the prior art references, other publications, documents explicitly or implicitly incorporated by
`
`reference, and testimony, to establish bases for combinations of certain cited references that
`
`render the asserted claims obvious. Further, for any combination, Medtronic reserves the right to
`
`rely additionally on information generally known to those skilled in the art and/or common
`
`sense.
`
`The references discussed herein and in the claim charts in Exhibits A through P, or
`
`elsewhere identified, may disclose the elements of the asserted claims explicitly and/or
`
`inherently, and/or they may be relied upon to show the state of the art in the relevant timeframe.
`
`The suggested obviousness combinations are provided in the alternative to Medtronic’s
`
`
`
`3
`
`
`
`
`
`anticipation contentions and are not to be construed to suggest that any reference included in the
`
`combinations is not itself anticipatory.
`
`Each reference cited herein and in the claim charts in Exhibits A through P, or elsewhere
`
`identified, and relied upon by Medtronic as a patent or printed publication under 35 U.S.C. §§
`
`102(a) or (b) should also be understood to be relied upon by Medtronic to establish that the
`
`disclosure therein was “known or used by others” under § 102(a) and/or “in public use or on
`
`sale” under § 102(b). Medtronic reserves the right to establish that the disclosure in any
`
`reference was known or used by others and/or in public use or on sale, irrespective and
`
`independent of the reference’s disclosure as a patent or a printed publication.
`
`Medtronic further reserves the right to assert that the asserted claims are invalid under 35
`
`U.S.C. § 102(f) in the event that Medtronic obtains evidence that the named inventor of the ‘393
`
`patent did not invent (either alone or in conjunction with others) the subject matter recited in the
`
`asserted claims. Should Medtronic obtain such evidence, it will provide the name of the
`
`person(s) from whom, and the circumstances under which, the invention or any part of it was
`
`derived. Medtronic further intends to rely on inventor admissions concerning the scope of the
`
`asserted claims or of the prior art relevant to the asserted claims found in, inter alia: the patent
`
`prosecution history and/or reexamination history for the ‘393 patent and related patents and/or
`
`patent applications; any deposition testimony of the named inventor of the ‘393 patent; and the
`
`papers filed and any evidence submitted by TMT in conjunction with this litigation or any
`
`related actions. To the extent any information is identified under § 102(f), Medtronic reserves
`
`the right to contend that the patent is invalid for failure to name the correct inventor, and/or to
`
`contend that TMT lacks standing to bring this litigation with respect to such patent.
`
`
`
`4
`
`
`
`
`
`Furthermore, nothing stated herein or in Exhibits A through P shall be treated as an
`
`admission or suggestion that Medtronic agrees with TMT regarding either the scope of any
`
`asserted claim or the claim constructions TMT advances in its Preliminary Infringement
`
`Contentions or anywhere else. To the extent that Medtronic’s Preliminary Invalidity Contentions
`
`reflect constructions of claim limitations consistent with or suggested by TMT’s Preliminary
`
`Infringement Contentions, no inference is intended nor should any be drawn that Medtronic
`
`agrees with TMT’s claim constructions. Nor shall anything in these Preliminary Invalidity
`
`Contentions be treated as an admission that Medtronic’s accused technology meets any limitation
`
`of any asserted claim. Medtronic denies that it infringes any claim of the ’393 patent. To the
`
`extent that any prior art reference identified by Medtronic contains a claim element that is the
`
`same as or similar to an element in an accused product, based on a claim construction inferred
`
`from TMT’s Preliminary Infringement Contentions and/or claim construction brief, inclusion of
`
`that reference in Medtronic’s Preliminary Invalidity Contentions shall not be deemed a waiver by
`
`Medtronic of any claim construction or noninfringement position. Medtronic expressly reserves
`
`the right to contest any claim construction asserted by TMT and expressly reserves all
`
`noninfringement arguments.
`
`Depending on the Court’s construction of the asserted claims of the ’393 patent, and/or
`
`positions that TMT or its expert witness(es) may take concerning claim interpretation,
`
`infringement, and/or invalidity issues, different ones of the charted prior art references in
`
`Exhibits A through P, or otherwise identified herein, may be of greater or lesser relevance and
`
`different combinations of these references may be implicated. Given this uncertainty, the charts
`
`may reflect alternative applications of the prior art against the asserted claims. Moreover, given
`
`this uncertainty, Medtronic also reserves the right to supplement with other references or
`
`
`
`5
`
`
`
`
`
`additional citations to existing references. Nothing stated herein shall be construed as an
`
`admission or a waiver of any particular construction of any claim term. Medtronic also reserves
`
`all rights to challenge any of the claim terms herein under 35 U.S.C. § 112, including by arguing
`
`that they are indefinite, not supported by the written description, and/or not enabled.
`
`Accordingly, nothing stated herein shall be construed as a waiver of any additional arguments
`
`available under 35 U.S.C. § 112.
`
`Medtronic reserves the right to establish that products identified in Section V.C embody
`
`the claims of the ’393 patent and such products were publicly used, offered for sale, or on sale in
`
`the United States more than a year before the priority date of the ’393 patent, as discussed below
`
`in Section III.A.1.
`
`III.
`
`PATENT-IN-SUIT
`A.
`
`U.S. Patent No. 7,101,393
`
`The ’393 patent, titled “Percutaneous Endovascular Apparatus for Repair of Aneurysms
`
`and Arterial Blockages,” issued to Timur P. Sarac on September 5, 2006, from U.S. Application
`
`No. 10/624,864, filed on July 22, 2003, and published on June 24, 2004, as US 2004/0122510.
`
`1.
`
`Priority Date of the ’393 patent
`
`The ’393 patent purports to claim priority to U.S. Provisional Patent Application No.
`
`60/397,745 (“’745 application”) filed on July 22, 2002. See Plaintiff TMT Systems, Inc.’s Initial
`
`Infringement Contentions at 2 (served on Feb. 5, 2021). However, the ’393 patent claims are
`
`only entitled to a priority date of July 22, 2003—the filing date of the non-provisional
`
`application.
`
`The ’393 patent claims are not entitled to a priority date of July 22, 2002, because the
`
`’745 application did not include Figure 13 and its corresponding description relied on by the
`
`applicant during prosecution of U.S. Application No. 10/624,864 (the “’864 application”), which
`
`
`
`6
`
`
`
`
`
`issued as the ’393 patent. For example, on March 24, 2005, the applicant received a restriction
`
`requirement in the ’864 application that grouped the then-pending claims into seven different
`
`species of the purported invention. TMT_0000048 at 171. In response, the applicant elected
`
`claims in “Specie 6, represented by Figure 13.” TMT_0000048 at 183. In a subsequent office
`
`action response, filed on September 22, 2005, the applicant stated that “[s]upport for the
`
`amendments and new claims can be found in the original claims and the specification…and
`
`FIGs. 13A-13G, 13H-13N, and 13O-13U.” TMT_0000048 at 204. The applicant also explained
`
`in a later communication to the patent office: “Applicant notes that the previous amendments and
`
`remarks are consistent with the meaning of the term ‘M configuration,’ used in the present
`
`claims. This is clearly demonstrated by the Applicant’s election of Specie 6 in response to the
`
`Restriction Requirement. In the Restriction Requirement, the Examiner noted that Figure 13N
`
`was representative of Specie 6.” TMT_0000048 at 301. Therefore, because Figure 13 and its
`
`corresponding description were relied on repeatedly by the applicant for providing written
`
`description support of the claims that issued from the ’864 application and were not disclosed in
`
`the ’745 application, the ’393 patent claims are only entitled to a priority date of July 23, 2003.
`
`Regardless of which priority date applies, all asserted claims of the ’393 patent are
`
`invalid for at least the reasons described herein. Medtronic further reserves the right to argue
`
`that a different priority date should apply.
`
`2.
`
`Asserted Claims of the ’393 patent
`
`According to TMT’s Preliminary Infringement Contentions served on February 5, 2021,
`
`TMT is asserting claims 1, 2, 4, 10, 11, and 26 of the ’393 patent.
`
`a.
`
`Claim 1
`
`Claim 1 of the ’393 patent claims:
`
`
`
`7
`
`
`
`
`
`An attachment device that is expandable from a first state to a second state for
`securing an endovascular apparatus to an interior wall of a lumen, the device
`comprising:
`a plurality of telescoping arms, the arms being operatively connected to one
`another so as to form a perimeter of variable length, wherein the telescoping arms
`are operatively coupled to one another at an angle so that multiple telescoping
`arms form the shape of a M.
`b.
`
`Claim 2
`
`Claim 2 of the ’393 patent depends from independent claim 1 (supra), and claims:
`
`The attachment device of claim 1, wherein the perimeter of variable length
`consists essentially of the plurality of telescoping arms arranged so as to form the
`shape of multiple Ms, and wherein the shape of the M is visible when viewed
`from a plane containing the perimeter of variable length, but is not visible when
`the device is viewed from a direction perpendicular to the plane containing the
`perimeter of variable length.
`c.
`
`Claim 4
`
`Claim 4 of the ’393 patent depends from independent claim 1 (supra), and claims:
`
`The attachment device of claim 1, wherein the ends of adjacent arms are
`operatively connected for pivotable movement.
`d.
`
`Claim 10
`
`Claim 10 of the ’393 patent depends from independent claim 1 (supra), and claims:
`
`The attachment device of claim 1, wherein the arms are made of a nickel-titanium
`alloy.
`
`e.
`
`Claim 11
`
`Claim 11 of the ’393 patent depends from independent claim 1 (supra), and claims:
`
`The attachment device of claim 1, wherein the attachment device when in the first
`state possesses a first profile that is sufficiently small to permit it to be
`percutaneously inserted via catheter into a patient's femoral artery.
`f.
`
`Claim 26
`
`Claim 26 of the ’393 patent claims:
`
`
`
`8
`
`
`
`
`
`An attachment device that is expandable from a first state to a second state for
`securing an endovascular apparatus to an interior wall of a lumen, the device
`comprising;
`A plurality of telescoping arms forming a closed loop, wherein the closed loop
`defines a plane by its circumference, wherein each telescoping arm is connected
`to another telescoping arm above or below the plane,—wherein the plurality of
`telescoping arms are coupled together in an M configuration.
`IV. GENERAL COMMENTS APPLICABLE TO THE ’393 PATENT
`
`Medtronic makes the following general comments that are applicable to the ’393 patent.
`
`A.
`
`General Reasons to Modify, Extend, or Combine Prior Art References
`
`The Supreme Court has held that “[t]he combination of familiar elements according to
`
`known methods is likely to be obvious when it does no more than yield predictable results.”
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “When a work is available in one field
`
`of endeavor, design incentives and other market forces can prompt variations of it, either in the
`
`same field or a different one.” Id. at 417. As the Supreme Court made clear, “[f]or the same
`
`reason, if a technique has been used to improve one device, and a person of ordinary skill in the
`
`art would recognize that it would improve similar devices in the same way, using the technique
`
`is obvious unless its actual application is beyond his or her skill.” Id.
`
`In order to determine whether there is an apparent reason to combine the known elements
`
`in the fashion claimed by the patents at issue, a court can “look to interrelated teachings of
`
`multiple patents; the effects of demands known to the design community or present in the
`
`marketplace; and the background knowledge possessed by a person having ordinary skill in the
`
`art.” Id. at 418. For example, obviousness can be demonstrated by showing “there existed at the
`
`time of invention a known problem for which there was an obvious solution encompassed by the
`
`patent’s claims.” Id. at 420. “[A]ny need or problem known in the field of endeavor at the time
`
`of invention and addressed by the patent can provide a reason for combining the elements in the
`
`
`
`9
`
`
`
`
`
`manner claimed.” Id. Common sense also teaches that “familiar items may have obvious uses
`
`beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the
`
`teachings of multiple patents together like pieces of a puzzle.” Id.
`
`Thus, the motivation to combine the teachings of the prior art references disclosed herein
`
`is found in the references themselves and/or: (1) the nature of the problem being solved; (2) the
`
`express, implied, and inherent teachings of the prior art; (3) the knowledge of persons of
`
`ordinary skill in the art; (4) the fact that the prior art is generally directed towards the same or
`
`similar problems; and/or (5) the predictable results obtained in combining the different elements
`
`of the prior art.
`
`The foregoing general comments are relevant to how a person of ordinary skill in the art
`
`(“POSA”) would understand prior art references in the field of the ’393 patent, and also relevant
`
`to which concepts a person of ordinary skill would deem obvious—both for single-reference
`
`obviousness and obviousness combinations.
`
`V.
`
`IDENTIFICATION OF PRIOR ART
`
`In addition to the disclosures provided below, Medtronic attaches separate charts
`
`detailing its invalidity contentions on a claim-by-claim basis. See Exhibits A through P.
`
`Moreover, Medtronic hereby discloses and reserves the right to rely upon all references
`
`incorporated by reference into the references disclosed below and in the accompanying charts.3
`
`For the avoidance of doubt (where not separately identified), identification of a granted patent by
`
`patent number also identifies the corresponding publication numbers and provisional application
`
`numbers.
`
`
`3 To the extent a cited reference is found not to predate the ’393 patent for which it is cited, it
`remains relevant, for example, to show the technological background and/or objective indicia of
`obviousness and/or obviousness based on simultaneous/contemporaneous invention by others.
`
`
`
`10
`
`
`
`
`
`A.
`
`Prior Art Patents / Patent
`
`Applications*
`
`The following
`
`art
`
`prior
`
`patents and patent applications, including
`
`those referenceslisted
`
`in Exhibits A
`
`through P, anticipate and/or render obvious the asserted claims of the ’393 patent.
`
`/
`PatentNo.
`Application No.
`U.S. Patent No.
`5,824,044 to
`Quiachon
`U.S. Patent No.
`6,524,335 to Hartle
`International
`
`Publication No. WO
`99/29262 to Hartle
`U.S. Patent No.
`6,695,875 to Stelter
`U.S. Patent
`
`Filing Date
`
`Issue or
`Publication
`Date
`
`Short
`Name
`
`Production No.
`
`Sept. 3, 1996
`
`Oct. 20,1998
`
`Quiachon
`
`MDT-TMT00003669
`
`Sept. 11,2000
`
`Feb. 25,2003
`
`Hartley
`
`°335
`
`MDT-TMT00003518
`
`Dec. 9, 1998
`
`June 17, 1999
`
`Hartley
`
`’262
`
`MDT-TMT00003491
`
`Mar. 14, 2001
`
`Feb. 24, 2004
`
`Stelter °875
`
`MDT-TMT00003723
`
`Mar. 14,2001
`
`Nov. 1, 2001
`
`Stelter °142
`
`MDT-TMT00003707
`
`Sept. 25, 1997
`May25,1998
`
`July 11, 2000
`Dec. 3, 1998
`
`Hartley ’761
`
`MDT-TMT00005463
`aa
`
`Oct. 22, 1998
`
`Oct. 17, 2000
`
`Chobotov
`
`MDT-TMT00003412
`
`Publication No.
`2001/0037142 to
`Stelter
`
`U.S. Patent No.
`International
`
`6,086,611 to Dufi
`
`98/53761 to Hartle
`
`6,878,161
`
`to Lenker
`
`5,387,235 to Chuter
`U.S. Patent No.
`6,132,457 to
`Chobotov
`
`5,855,601 to Bessler
`
`6,423,090 to Hancock
`
`6,517,570 to Lau
`
`(Fed. Cir. 2015) 11
`
`*
`
`To the extent TMT contentsthat a reference is not
`a
`to
`the
`Dynamic Drinkware
`right
`perform
`Graphics, Inc., 800 F.3d 1375
`
`analysis.
`
`art under § 102(e), Medtronic reserves
`prior
`Dynamic Drinkware, LLC v. Nat’l
`See
`
`
`
`
`/
`Short
`PatentNo.
`Application No.
`Name
`U.S. Patent No.
`to Lau
`
`Filing Date
`
`Issue or
`Publication
`Date
`
`Production No.
`
`
`Additional Prior Art References
`
`5,919,225
`
`July 14,1997
`
`July
`
`6, 1999
`
`Lau °225
`
`MDT-TMT00003951
`
`May 28, 1998
`
`July 4, 2000
`
`MDT-TMT00003723
`
`214
`
`5,797,951 to Mueller
`
`6,083,258 to Yadav
`
`6,309,343
`
`to Lentz
`
`6,165,214 to Lazarus
`
`6,306,141 to Jervis
`
`B.
`
`The following references may be relied upon to demonstrate the state of the art and/or the
`
`of a
`
`person of ordinary skill in theart as it relates to the ’393 patent in the relevant
`
`knowledge
`
`timeframe.
`
`All documents cited on the face of the ’393 patent and related patents, patent
`
`publications,file histories, and applications,
`Patent No. /
`Application No./
`.
`Title
`
`Filing Date
`
`as well as:
`
`Issue or
`Publication
`
`Date
`Jun. 23,1992
`
`U.S. Patent No.
`5,123,917 to Lee
`Charles T. Dotter et
`
`Apr. 27, 1900
`
`n/a
`
`Short
`N
`ame
`
`Production No.
`
`Lee
`
`MDT-TMT00003368
`
`1983
`
`Dotter 1983
`
`MDT-TMT00003288
`
`April
`
`al., Transluminal
`Expandable Nitinol
`Coil Stent
`Grafting
`147
`259
`
`Report,
`Radiology
`
`
`
`12
`
`
`
`
`Issue or
`Patent No./
`Publication
`
`Filing
`
`Date
`
`n/a
`
`Date
`1983
`
`April
`
`Short
`
`Name
`
`Production No.
`
`Cragg
`
`1983
`
`MDT-TMT00003275
`
`No. /
`
`.
`Application
`Title
`Andrew Cragget al.,
`Nonsurgical
`Placement of
`Arterial
`
`A
`
`Endoprostheses:
`New
`Technique
`Using Nitinol Wire,
`147
`261
`Radiology
`
`3,174,851
`
`to Buehler
`
`3,351,462 to Rozner
`U.S. Patent No.
`3,753,700 to
`Harrison
`Frank J. Criado et
`al., Endovascular
`
`Grafting of
`AbdominalAortic
`
`July 2, 1970
`
`Aug. 21,1973
`
`Harrison
`
`MDT-TMT00003365
`
`n/a
`
`1999
`
`Sept.
`
`Criado 1999
`
`MDT-TMT00003748
`
`Aneurysms (AAA):
`Historical
`Development and
`Evolving
`11 J.
`Technologies,
`Invasive Cardiology
`
`Frank J. Criado et al,
`Abdominal Aortic
`Overview
`
`Aneurysm:
`ofStent-Graft
`Devices, 194 J. Am.
`of Surgeons
`College
`
`Harrison M.Lazarus,
`Endovascular
`the
`
`Graftingfor
`Treatment
`of
`Abdominal Aortic
`74
`Aneurysms,
`Surgical Clinics of
`N. Am. 959
`(Aug.
`
`n/a
`
`Jan. 2002
`
`Criado 2002
`
`MDT-
`
`00003278
`
`n/a
`
`Aug. 1992
`
`Lazarus
`
`MDT-TMT00003290
`
`1992
`
`13
`
`
`
`
`Issue or
`Patent No./
`Publication
`
`Filing
`
`Date
`
`Date
`
`Short
`
`Name
`
`Production No.
`
`Nov. 1994
`
`Parodi 1994
`
`MDT-TMT00003334
`
`1997
`
`May
`
`1997
`
`MDT-TMT00003350
`
`No. /
`
`.
`Application
`Title
`Juan C. Parodi et al.,
`Endoluminal Aortic
`
`Aneurysm Repair
`a Balloon-
`Using
`Stent-
`Expandable
`Device: A
`Graft
`Progress Report,
`Annals Vascular
`Surgery 523 (Nov.
`
`8
`
`et
`al.,
`Thompson
`Aortomonoiliac
`
`Endovascular
`
`Grafting: Difficult
`Solutions to
`Difficult
`Aneurysms, 4 J.
`Endovascular
`Surgery 174
`
`(May
`
`Vascular Surgery
`
`n/a
`
`Mar. 22,1997
`
`MDT-TMT00003390
`
`van der
`Vliet 1997
`
`Sept. 3, 1994
`
`Yusuf 1994
`
`MDT-TMT00003395
`
`Nov. 1991
`
`Parodi 1991
`
`MDT-TMT00003341
`
`J. Adam van der
`Viietet al.,
`Abdominalaortic
`aneurysm, 349
`Lancet 863
`(Mar. 22,
`
`S.W. Yusufet al.,
`Transfemoral
`endoluminal repair
`abdominal
`of
`aneurysmwith
`
`bifurcated graft,
`Lancet 650
`(Sept. 3,
`
`344
`
`Transfemoral
`Intraluminal
`Graft
`Implantationfor
`Abdominal Aortic
`5 Annals
`
`Aneurysms,
`
`14
`
`
`
`
`Issue or
`Patent No./
`Publication
`
`Filing
`
`Date
`
`Date
`
`Short
`
`Name
`
`Production No.
`
`No. /
`
`.
`Application
`Title
`Juan C. Parodi,
`Endovascular Repair
`ofAbdominal Aortic
`Aneurysms in
`Advancesin
`Vascular Surgery 85
`ol. 1 1993
`David Mirichetal.,
`
`n/a
`
`1993
`
`Parodi 1993
`
`MDT-TMT00003305
`
`Mar. 1989
`
`Mirich 1989
`
`MDT-TMT00003300
`
`Percutaneously
`Placed Endovascular
`Aortic
`
`Graftsfor
`Aneurysms:
`Feasibility Study,
`
`170
`
`1033
`
`Rainey
`4,505.767 to
`feeES[se
`Quin
`
`4,665,906 to Jervis
`
`SrA
`
`5,316,023 to Palmaz 15
`
`to Lazarus
`5,397,345
`U.S. Patent No.
`to
`
`5,713,917
`Leonhardt
`
`5,824,041 to Lenker
`
`5,871,536 to Lazarus
`
`6,368,345 to
`Dehdashtian
`
`8,206,427
`
`to Ryan
`
`5,360,443 to Barone
`
`5,575,817 to Martin
`U.S. Patent No.
`5,609,627 to
`Goicoechea
`U.S. Patent No.
`
`Sept. 18, 1996
`
`Feb. 3, 1998
`
`Leonhardt
`
`MDT-TMT00003885
`
`"345
`
`536
`
`Oct. 4, 1994
`
`Mar. 11,1997
`
`Goicoechea
`
`MDT-TMT00003849
`
`"627
`
`Jan. 8, 1992
`
`May 31,1994
`
`Palmaz ’023
`
`MDT-TMT00003796
`
`
`
`
`
`Issue or
`Patent No./
`Publication
`
`Filing
`
`Date
`
`Sept. 29, 1994
`
`Date
`Apr. 6, 1995
`
`Short
`
`Name
`
`Production No.
`
`White
`
`MDT-TMT00004091
`
`No. /
`
`.
`Application
`Title
`International
`Publication No. WO
`95/08966 to White
`International
`Publication No. WO
`95/21592 to
`Goicoechea
`Frank J. Criado et
`
`al., Early Experience
`with the Talent Stent-
`
`Graft Systemfor
`Endoluminal Repair
`ofAbdominal Aortic
`Tex.
`Aneurysms,
`Heart Inst. J. 128
`27 No. 2 Nov.
`
`(Vol.
`
`U.S. Patent No.
`6,579,307 to Sarac
`U.S. Patent
`Publication No.
`2002/0156523 to
`Lau
`Alexander Balko,
`Transfemoral
`Placement of
`Intraluminal
`
`Polyurethane
`Prosthesisfor
`AbdominalAortic
`Aneurysm, 40 J.
`Res. 305
`Surg.
`
`7,264,632 to Wright
`
`P990017/S030A
`
`and
`Safety
`Effectiveness Data
`
`Same
`for Use
`
`Feb. 6, 1995
`
`Aug. 17,1995
`
`Goicoechea
`592
`
`MDT-TMT00004112
`
`Nov.2, 2000
`
`Criado 2000
`
`MDT-TMT00003743
`
`July 19, 2001
`
`June 17, 2003
`
`Sarac ’307 MDT-TMT00004027
`
`June 7, 2002
`
`Oct. 24, 2002
`
`Lau °523
`
`MDT-TMT00003761
`
`n/a
`
`1986
`
`Balko 1986
`
`MDT-TMT00003743
`
`30A
`
`30A
`
`30C
`
`P990017/S030C 16
`
`
`
`Filing
`
`Date
`
`n/a
`
`Issue or
`Publication
`
`Date
`Sept. 28, 1999
`
`Short
`
`Name
`
`Production No.
`
`P990017C
`
`MDT-TMT00006695
`
`399
`
`n/a
`
`Nov. 6, 2002
`
`P020004B
`
`MDT-TMT00006974
`
`Patent No./
`
`No./
`
`.
`Application
`Title
`Ancure Essential
`
`Prescribing
`Information (EPI)
`and Operator’s
`Instructions for Use
`
`5,064,435 to Porter
`
`5,104,399 to Lazarus
`
`5,562,726
`
`to Chuter
`
`5,571,173 to Parodi
`
`P020004A
`Excluder Summary
`of
`and
`Safety
`Effectiveness
`
`P020004B
`
`P020004C
`
`P020004D
`
`5,632,772 to Alcime
`
`5,693,088 to Lazarus
`
`5.824.037
`
`to Foge
`
`6,099,558
`
`to White
`
`6,221,102 to Baker
`
`6,312,460 to Drasler
`
`of| n/a
`
`P990020A
`AneuRx Summary
`Safety and
`Effectiveness
`P990020B
`AneuRx Instructions
`for Use P990020C
`
`088
`
`"037
`
`Sept. 28, 1999
`
`P990020B
`
`MDT-TMT00006755
`
`n/a
`
`Sept. 28, 1999
`
`P990020C
`
`MDT-TMT00006803
`
`17
`
`
`
`Patent No./
`
`No. /
`
`.
`Application
`Title
`U.S. Patent No.
`to Murph
`6,409,756
`U.S. Patent No.
`to White
`6,565,596
`U.S. Patent
`
`Publication No.
`2001/0053930 to
`
`U.S. Patent
`
`Publication No.
`2003/0120338 to
`
`Chobotov
`U.S.Patent
`
`Publication No.
`
`2003/0199967to
`Hartle
`U.S. Patent
`
`Filing
`
`Date
`
`Jan. 24, 2000
`
`Issue or
`Publication
`
`Date
`June 25,2002
`
`Short
`
`Name
`
`Murphy
`
`Production No.
`
`MDT-TMT00007468
`
`Sept. 9, 1999
`
`May 20, 2003
`
`White °596
`
`MDT-TMT00007476
`
`Aug. 23, 2001
`
`Dec. 20,2001
`
`Kugler
`
`930
`
`MDT-TMT00007111
`
`Mar. 5, 2002
`
`June 26, 2003
`
`Chobotov
`
`MDT-TMT00007152
`
`°338
`
`Mar.25, 2003
`
`Oct. 23,2003
`
`Hartley
`
`"967
`
`MDT-TMT00007181
`
`Aug. 20, 2003
`
`Apr. 29, 2004
`
`Cook ’989 MDT-TMT00007197
`
`562
`
`18
`
`Publication No.
`2004/0082989 to
`Cook
`
`Publication No. WO
`97/12562 to Foga
`Zenith Approval
`P020018A
`Zenith Summary of
`Safety and
`Effectiveness
`
`P020018B
`
`P020018C
`Cherrie Z. Abraham
`et
`al., Abdominal
`aortic aneurysm
`repair with the
`Zenith stent
`graft:
`Short to midterm
`results 217
`
`(Vol.36
`
`n/a
`
`n/a
`
`May 23, 2003
`
`May 23, 2003
`
`P020018A
`
`MDT-TMT00007597
`
`P020018B
`
`MDT-TMT00007647
`
`2002
`
`Aug.
`
`Abraham
`
`MDT-TMT00006616
`
`2002
`
`
`
`
`Issue or
`Patent No./
`Publication
`
`Filing
`
`Date
`
`Date
`
`Short
`
`Name
`
`Production No.
`
`Dec. 1998
`
`Allen 1998
`
`MDT-TMT00006625
`
`2001
`
`Sept.
`
`Bush 2001
`
`MDT-TMT00006844
`
`No. /
`
`.
`Application
`Title
`Brent T. Allen et al.,
`Endovascular Stent
`
`(Vol.
`
`Graftsfor
`Aneurysmal and
`Occlusive Vascular
`Disease 574
`176
`
`1998)
`Ruth L. Bushet al.,
`Earlyexperience
`with the bifurcated
`Excluder
`
`endoprosthesis for
`treatment
`ofthe
`abdominalaortic
`aneurysm, 34 J.
`Vascular Surgery
`497
`(Sept. 2001)
`
`P.
`Carpenter,
`Jeffrey
`Multicentertrial of
`the PowerLink
`
`bifurcated systemfor
`endovascularaortic
`aneurysmrepair, 36
`J. Vascular
`Surgery
`1129 (Dec. 2002)
`A.M.
`
`Timothy
`Chuteret