BSI-140
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`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`:Art Unit: 3308
`:Examiner: M. Milano
`
`/.
`1· 1
`RESPONSE UNDER 37 C.P.R. l.liRECE~V/ED
`JUN 2 5 1997
`GROUP3309
`
`Assistant Commissioner for Patents
`Washington, D.C. 20231
`
`SIR:
`
`l
`I.
`(~·
`
`Responsive to the Office Action mailed January 21, 1997, please
`amend this application as follows and reconsider the application in light of
`those amendments and the subsequent remarks.
`
`IN THE CLAIMS:
`
`~ ~
`Please cancel claims 56 and 66-87 without prejudice.
`
`~
`/
`'
`Please amend claims 55, 59, and 63 and add new claims 88, 89,
`and 90 as follows:
`
`]
`
`1
`2
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`55.
`(Twice Amended ) A method of treating an angeological
`disease at a bifurcation site where a blood vessel branches into a first
`branched vessel and a second branched vessel using a birfucation prosthesis
`[stent] having a bifurcation, a proximal portion, a first distal portion, and an
`extension portion extending distally relative to said bifurcation, and using a
`second prosthesis [stent], said method comprising the steps of:
`
`SLS _1:\BSI\140\AMENDOl.DOC
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-1
`
`
`
`' '
`
`•
`
`•
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`:Art Unit: 3308
`:Examiner: M. Milano
`
`/.
`1· 1
`RESPONSE UNDER 37 C.P.R. l.liRECE~V/ED
`JUN 2 5 1997
`GROUP3309
`
`Assistant Commissioner for Patents
`Washington, D.C. 20231
`
`SIR:
`
`l
`I.
`(~·
`
`Responsive to the Office Action mailed January 21, 1997, please
`amend this application as follows and reconsider the application in light of
`those amendments and the subsequent remarks.
`
`IN THE CLAIMS:
`
`~ ~
`Please cancel claims 56 and 66-87 without prejudice.
`
`~
`/
`'
`Please amend claims 55, 59, and 63 and add new claims 88, 89,
`and 90 as follows:
`
`]
`
`1
`2
`3
`4
`5
`6
`
`55.
`(Twice Amended ) A method of treating an angeological
`disease at a bifurcation site where a blood vessel branches into a first
`branched vessel and a second branched vessel using a birfucation prosthesis
`[stent] having a bifurcation, a proximal portion, a first distal portion, and an
`extension portion extending distally relative to said bifurcation, and using a
`second prosthesis [stent], said method comprising the steps of:
`
`SLS _1:\BSI\140\AMENDOl.DOC
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-1
`
`
`
`BSI-140
`
`-2-
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`•
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`•
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`(a) disposing said proximal portion of said bifurcated prosthesis
`[stent] in said blood vessel such that said first distal portion of said bifurcated
`prosthesis [stent] extends into said first branched vessel;
`
`~ to"~'
`
`7
`8
`9
`
`10
`11
`12
`
`13
`14
`IS
`
`16
`17
`
`1
`2
`3
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`s
`6
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`1
`2
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`3
`4
`s
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`(b) directing blood flow from said blood vessel into said first
`branched vessel through said first distal portion of said bifurcated prosthesis
`[stent];
`
`(c) attaching said second prosthesis [stent] to said extension
`portion of said bifurcated prosthesis [stent] such that said second prosthesis
`[stent] extends into said second branched vessel; and
`
`(d) directing blood flow from said blood vessel into said second
`branched vessel through said second prosthesis [distal portion of said
`
`59. (Amended) A bifurcated prosthesis [stent] for use [in
`juxtaposition] with an angeological bifurcation of a blood vessel into two
`branched vessels comprising a bifurcated proximal [stent] portion adapted to
`be disposed within said blood vessel [in juxtaposition with said bifurcation], a
`distal [stent] portion adapted to extend across the bifurcation into one of the
`branched vessels, and a separate distal [stent] segment joined to said proximal
`portion and adapted to allow blood to flow from the proximal portion into the
`other branched vessel.
`
`(Amended) A method as claimed in claim 55 further
`63.
`comprising the step of:
`
`covering at least a portion of said proximal portion, said
`(d)
`first distal portion, and said second prosthesis [distal portion] with a graft
`layer.
`
`(Newly added) The bifurcated prosthesis of claim 59
`88.
`1
`2 wherein said proximal portion, distal portion, and distal segment each
`comprise a stent and graft combination.
`3
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-2
`
`
`
`1
`2
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`3
`4
`
`s
`6
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`1
`s
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`9
`10
`11
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`1
`2
`3
`4
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`BSI-140
`
`- 3 -
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`•
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`•
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`89.
`lumen comprising:
`
`(Newly added) An apparatus for reinforcing a bifurcated
`
`a first section, configured to be positioned within the lumen,
`
`comprising:
`
`an upper limb, configured to fit within the lumen upstream of
`the bifurcation;
`
`a first lower limb, configured to extend into a first leg of said
`bifurcation when said first section is positioned in the lumen, and
`
`a second lower limb, shorter than said first lower limb, and
`configured so that when said first section is positioned in the lumen, said
`second lower limb does not extend into a second leg of said bifurcation.
`
`(Newly added) The apparatus of claim 89, further
`90.
`comprising a second section configured to be positioned separately within the
`lumen and joined to said second lower limb of the first section, effectively
`extending said second lower limb into said second leg of said bifurcation.
`
`REMARKS
`
`Response to Restriction Requirement
`
`Applicant hereby confirms the election of Group I, claims 55,
`59, and 62-65, for further prosecution in this application. This election is
`made without traverse. Claims 55, 59, and 62-65 were pending in this
`application as of the issuance of the Office Action. By this amendment,
`Applicant has added claims 88, 89 and 90, all of which are directed to the
`same invention as the elected claims.
`
`SI3 _1:\BSI\140\AMENDOt.DOC
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-3
`
`
`
`BSI-140 •
`
`•
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`-4-
`
`Response to Pending Rejection
`
`Claims 55, 59, and 62-65 stand rejected in the Official Action
`under 35 U.S.C. § 102(e) as anticipated by U.S. Patent No. 5,575,817
`(Martin).
`
`Martin was filed on August 19, 1994. The present application is
`a divisional of application Serial No. 08/317,763, filed October 4, 1994,
`which is in tum a continuation-in-part of application Serial No. 08/312,881,
`filed September 27, 1994. Both of these applications have effective filing
`dates based on two EPO applications, one filed February 9, 1994 and one
`filed June 10, 1994. The priority claim to the EPO applications antedates the
`August 19, 1994 filing date of Martin, thus eliminating the patent as a
`reference against this application. Eliminating this patent as a reference
`' obviates the claim rejections over Martin. Withdrawal of the rejection of the
`claims based on this reference is therefore respectfully requested.
`
`Priority of the same EPO applications is made and
`acknowledged in the parent and grandparent applications, and certified copies
`of the EPO priority applications were filed in both of those cases. Applicant
`understands that no certified copy need be filed in the present case because of
`the prev:ious filings in the parent cases, but Applicant will do so if requested
`by the Examiner.
`
`Claims 55, 59, and 63 have been amended, and claim 88 has
`been added, to better define Applicant's invention. Newly added claims 89
`and 90, copies of claims 1 and 2 in the cited Martin patent, are also clearly
`patentable to Applicants for the same reasons stated with regard to the
`pending rejections (see further discussion below regarding Applicant's request
`for an interference to be declared between this application and the Martin
`patent).
`
`\
`\
`
`In light of the above amendments and remarks, it is respectfully
`submitted that the claims of the present application are in condition for
`allowance, which action is earnestly solicited.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-4
`
`
`
`BSI-140 •
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`-5-
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`-*'" Request for Declaration of Interference
`
`In view of the fact that the reference relied upon in the pending
`rejection is an issued patent, which issued within the past six months, and the
`recognition in the rejection statement that Applicant appears to be claiming the
`same invention as disclosed in the reference, Applicant respectfully suggests
`
`ll that an interference should be declared between this application and the cited
`\ reference. In furtherance of this suggestion, Applicant has added new claims
`ffl \ 89 and 90, which are copies of claims I and 2 of the cited patent.
`Accordingly, Applicant respectfully requests that an interference be declared
`with at least one count corresponding to each of claims 89 and 90 hereof
`(claims 1 and 2 of Martin).
`
`As explained above, the effective filing date of the present
`application is believed to be February 9, 1994 by virtue of the priority claims
`in this application. Because this effective filing date antedates Martin's filing
`date, Applicant should be senior party in any interference that is declared.
`
`As a matter of information, Applicant has also proposed that the
`Interference between Applicant and the Martin patent encompass claim 66 of
`Applicant's U.S. application Serial Number 312,881, filed September 27,
`1994, and claims 63 and 65 of Applicant's U.S. application Serial Number
`~63,987, filed June 5, 1995.
`
`Upon declaration of the Interference, Applicant will place each
`of the interfering claims of its various applications into a single application,
`request that they be added to the Interference, and cancel them from the
`respective applications in which they now appear.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-5
`
`
`
`BSI-140 •
`
`•
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`-6-
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`The Examiner in charge of this application is invited to call
`either of Applicant's undersigned attorneys if any further information is
`needed or if it will expedite the prosecution of the referenced applications in
`any way.
`
`Respectfully Submitted,
`
`•
`
`AMW:sls
`Dated: May 22, 1997
`Suite 301
`One Westlakes, Berwyn
`P.O. Box 980
`Valley ForgeJ.JA 19482-0980
`(610) 407-07uu
`
`The Assistant Commissioner for Patents is hereby
`authorized to charge payment to Deposit Account No.
`18-0350 of any fees associated with this
`communication.
`
`I hereby certify that this correspondence is being deposited with the
`United States Postal Service as first class mail in an envelope, with
`suffiCient postage, addressed to: Assistant Commissioner for
`Patents, Washington, D.C. 20231 on:
`
`~r}J C}ii?l
`
`W.L. Gore & Associates, Inc.
`Exhibit 1016-6
`
`
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