UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/601,902
`
`08/3112012
`
`Andrew H. Cragg
`
`94-P0272US02
`
`1430
`
`54953
`7590
`03/25/2013
`BROOKS, CAMERON & HUEBSCH, PLLC
`1221 NICOLLET A VENUE
`SUI1E 500
`MINNEAPOLIS, MN 55403
`
`EXAMINER
`
`HOLWERDA, KATHLEEN SONNETT
`
`ART UNIT
`
`PAPER NUMBER
`
`3731
`
`MAIL DATE
`
`03/25/2013
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-1
`
`

`

`Application No.
`
`Applicant(s)
`
`Office Action Summary
`
`CRAGG ET AL.
`13/601 ,902
`Art Unit
`Examiner
`KATHLEEN HOLWERDA
`3731
`-- The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;2 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR t. t 36(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § t33).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR t .704(b).
`Status
`1 )IZ! Responsive to communication(s) filed on 31 August 2012.
`2b)[8J This action is non-final.
`2a)0 This action is FINAL.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ;the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C. D. 11, 453 O.G. 213.
`Disposition of Claims
`5)[8J Claim(s) 1-20 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8J Claim(s) 1-20 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway
`program at a participating intellectual property office for the corresponding application. For more information, please see
`htto:/iwww.us..Qto.aov/oatents/init events/gQh/index.jsQ or send an inquiry to PPHfeedback@us.Qto.qov.
`Application Papers
`1 O)IZ! The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`Priority under 35 U.S.C. § 119
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) [8J Notice of References Cited (PT0-892)
`2) 0 Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date __ .
`U.S. Patent and Trademark Off1ce
`PTOL-326 (Rev. 09·12)
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20130311
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-2
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 2
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`DETAILED ACTION
`
`Priority
`
`1.
`
`Applicant has been notified in other applications, including in application 08/312,881,
`
`that the Office considers any priority claim to EP 94400284.9 or EP94401306.9 to be improper
`
`in light of Boston Scientific Scimed Inc. v. Medtronic Vascular Inc., 83 USPQ2d 1669 (Fed. Cir.
`
`2007). Applicant's representatives have been put on notice that ill!_ applications or patents
`
`which contain this priority claim are considered improper and should be corrected without delay
`
`or awaiting further notice from the Office. Applicant has not taken the proper steps to correct
`
`these improper benefit claims, which have been fully adjudicated. For example, see USP
`
`7,901 ,449, which does not contain either a certificate of correction or reissue to correct the
`
`patent. Applicant continues to file applications with benefit claims to the two EP applications,
`
`such as in this application and in copending application 13/603,937. Applicant is responsible for
`
`ensuring that all applications contain only benefit claims to prior applications for which applicant
`
`believes applicant has a valid claim. Applicant's continued filing of improper benefit claims in
`
`applications filed five years after applicant has received a final opinion from the CAFC cannot be
`
`construed as complying with applicant's duty to make proper representations to the Office. See
`
`37 CFR 1 .56 and 1 0.23.
`
`2.
`
`For the purpose of this Office action, applicant's priority date is considered to be
`
`September 27, 1994. Should applicant have any questions related to the question of priority
`
`claims, applicant should contact TC 3700 Interference Practice Specialist, Josie Ballato, at 571-
`
`272-3567.
`
`Information Disclosure Statement
`
`3.
`
`The references cited in the Information Disclosure Statements filed in parent Application
`
`08/312,881 have been considered, but will not be listed on any patent resulting from this
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-3
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 3
`
`application because they were not provided on a separate list in compliance with 37 CFR
`
`1.98(a)(1 ).
`
`In order to have the references printed on such resulting patent, a separate listing,
`
`preferably on a PTO/SB/08A and 088 form, must be filed within the set period for reply to this
`
`Office action.
`
`Specification
`
`4.
`
`The abstract of the disclosure is objected to because it includes legal phraseology
`
`("means" in second to last line). Correction is required. See MPEP § 608.01 (b).
`
`Claim Rejections- 35 USC§ 112
`
`5.
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`(B) CONCLUSION.-The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AlA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`6.
`
`Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), second
`
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
`
`matter which the inventor or a joint inventor, or for pre-AlA the applicant regards as the
`
`invention.
`
`a.
`
`Claim 1 : in line 9, "said first stent" lacks antecedent basis. The first stent is also
`
`referenced in line 38.
`
`b.
`
`c.
`
`Claim 1: in line 12, insert "each" between "portion" and "comprise".
`
`Claim 1 : in lines 29 and 30, the claim includes that the bifurcated stent is
`
`configured to be joined in situ to said second stent. However, the second stent is
`
`currently claimed as part of the bifurcated stent since the preamble of the claim is drawn
`
`to the bifurcated stent. Therefore, it is unclear what is meant by this limitation.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-4
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 4
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`d.
`
`e.
`
`end".
`
`f.
`
`g.
`
`Claim 1: "said proximal end" in line 31 should read "a proximal end".
`
`Claim 1: "said distal end" which bridges lines 32 and 33 should read "a distal
`
`Claim 1: in line 34, "after joined" should read -after being joined--.
`
`Claim 1: please insert "of said proximal stent portion" after "said proximal end" in
`
`the last line of the claim since several different proximal ends are claimed.
`
`h.
`
`i.
`
`Claim 11: "said first. .. stent" in line 1 and line 3 lacks antecedent basis.
`
`Claim 11: as currently worded, it is unclear if claim 11 is claiming an additional
`
`graft layer (in addition to the two already claimed in claim 8) or if this graft layer is meant
`
`to refer back to one of the two graft layers of claim 8.
`
`j.
`
`Claim 12: "said first stent" in line 9 lacks antecedent basis. The first stent is also
`
`referenced in line 30.
`
`k.
`
`I.
`
`m.
`
`n.
`
`o.
`
`Claim 12: in line 12, insert "each" between "portion" and "comprise".
`
`Claim 12: in line 23, "said proximal end" should read "a proximal end".
`
`Claim 12: in line 25, "said distal end" should read "a distal end".
`
`Claim 12: in line 27, "after joined" should read "after being joined".
`
`Claim 12: please insert "of said proximal stent portion" after "said proximal end"
`
`in the last line of the claim since several different proximal ends are claimed.
`
`p.
`
`q.
`
`Claim 16: in line 8, "said first stent" lacks antecedent basis.
`
`Claim 16: in line 10, "said wire" lacks antecedent basis. The wire is also
`
`referenced in lines 1 0, 11, and 14.
`
`r.
`
`s.
`
`t.
`
`Claim 16: "said proximal end" should read "a proximal end".
`
`Claim 16: "said distal end" in line 21 should read "a distal end".
`
`Claim 16: in line 23, "after joined" should read "after being joined".
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-5
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 5
`
`u.
`
`v.
`
`Claim 20: "said first. .. stent" in lines 1 and 3 lacks antecedent basis.
`
`Claim 20: it is unclear if claim 20 is claiming an additional graft layer (in addition
`
`to the two already claimed in claim 17) or if this graft layer is meant to refer back to one
`
`of the two graft layers of claim 8.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
`improper timewise extension of the "right to exclude" granted by a patent and to prevent
`possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting
`rejection is appropriate where the conflicting claims are not identical, but at least one examined
`application claim is not patentably distinct from the reference claim(s) because the examined
`application claim is either anticipated by, or would have been obvious over, the reference
`claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re
`Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225
`USPQ 645 (Fed. Cir. 1985); In re VanOrnum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re
`Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d) may be
`used to overcome an actual or provisional rejection based on a nonstatutory double patenting
`ground provided the conflicting application or patent either is shown to be commonly owned with
`this application, or claims an invention made as a result of activities undertaken within the scope
`of a joint research agreement.
`Effective January 1, 1994, a registered attorney or agent of record may sign a terminal
`disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
`
`7.
`
`Claim 16 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 11 of U.S. Patent No. 5,800,508. Claim 11 of '508 claims the
`
`invention of instant claim 1 substantially including a proximal stent portion ("endoluminal stent"),
`
`a first distal stent portion and an intermediate stent portion ("at least one additional stent
`
`segment of frustoconical shape") and a second distal stent portion ("additional stent segment
`
`having mating frustoconical shape"; see claims 9 and 1 0), the intermediate stent portion having
`
`a distal orifice at the distal end of at least one of the tapering portions which when in an
`
`expanded configuration forms a frustoconical female engaging portion serves to receive the
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-6
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 6
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`male engaging portion having the frustoconical configuration of the distal stent completely within
`
`the female engaging portion of the orifice (see esp. lines of claim 1 0). The stent portions
`
`comprise a plurality of hoops lying in planes perpendicular to the longitudinal axis, each of the
`
`hoops being formed of a substantially complete turn of a sinuous wire. Therefore, the device of
`
`claim 16 is considered "anticipated" by the device of claim 11 of '508.
`
`8.
`
`Claims 17-20 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claim 11 of U.S. Patent No. 5,800,508 in view of Martin
`
`(US 5,575,817). Claim 11 of '508 discloses the invention substantially but fails to disclose the
`
`claimed graft layers.
`
`9.
`
`However, covering stents with graft material when treating aneurysms is well known in
`
`the art. For example, Martin teaches another bifurcated stent assembly and further discloses
`
`that the stents may be "entirely covered" by a graft (col. 3 II. 14-16) and therefore the graft on
`
`the inner surface of the intermediate portion (5) which forms the female cooperating portion may
`
`be considered the first graft layer and the graft covering the external surface of the second distal
`
`portion which forms the male engaging portion can be considered the second graft layer. Such a
`
`fabric layer is advantageous because it isolates the blood flow from the weakened vessel wall
`
`and therefore adding such a graft material to the stents of claim 11 of '508 would have been
`
`obvious to one of ordinary skill in the art.
`
`1 0.
`
`Claims 1 and 12 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claim 11 of U.S. Patent No. 5,800,508 in view of Chaikof
`
`et al. (US 5, 7 41 ,325; "Chaikof"). Claim 11 of '508 claims the invention of instant claim 1
`
`substantially including a proximal stent portion ("endoluminal stent"), a first distal stent portion
`
`and an intermediate stent portion ("at least one additional stent segment of frustoconical
`
`shape") and a second distal stent portion ("additional stent segment having mating frustoconical
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-7
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 7
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`shape"; see claims 9 and 1 0), the intermediate stent portion having a distal orifice at the distal
`
`end of at least one of the tapering portions which when in an expanded configuration forms a
`
`frustoconical female engaging portion serves to receive the male engaging portion having the
`
`frustoconical configuration of the distal stent completely within the female engaging portion of
`
`the orifice (see esp. lines of claim 1 0). The stent portions comprise a plurality of hoops lying in
`
`planes perpendicular to the longitudinal axis, each of the hoops being formed of a substantially
`
`complete turn of a sinuous wire. Claim 11 of '508 does not include that the proximal end of the
`
`proximal stent portion is flared radially outwardly towards it extremity and adapted to engage an
`
`endoluminal surface of the blood vessel.
`
`11.
`
`Chaikof teaches a stent apparatus comprising a bifurcated stent and a second stent
`
`wherein the bifurcated stent has a proximal stent portion which is generally cylindrical except for
`
`a flared proximal end (shown near ref. number 8 in fig. 6). This flared portion engages the
`
`endoluminal surface of the blood vessel as shown in figs. 4 and 5 for example and helps resist
`
`movement of the deployed stent (see also col. 4, II. 30-44). It would have been obvious to one
`
`skilled in the art to have modified the device of claim 11 of '508 to construct the proximal stent
`
`portion generally cylindrical except for a proximal end flare in order to improve the anchoring of
`
`the stent within the vessel as taught by Chaikof.
`
`12.
`
`Claims 2, 8-11, and 13 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 11 of U.S. Patent No. 5,800,508 in view of
`
`Chaikof as applied to claim 1 and further in view of Martin (US 5,575,817). Claim 11 of '508
`
`discloses the invention substantially but fails to disclose the claimed graft layers as well as the
`
`first distal stent portion being formed integrally with the proximal stent portion.
`
`13.
`
`However, covering stents with graft material when treating aneurysms is well known in
`
`the art. For example, Martin teaches another bifurcated stent assembly and further discloses
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-8
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 8
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`that the stents may be "entirely covered" by a graft (col. 3 II. 14-16) and therefore the graft on
`
`the inner surface of the intermediate portion (5) which forms the female cooperating portion may
`
`be considered the first graft layer and the graft covering the external surface of the second distal
`
`portion which forms the male engaging portion can be considered the second graft layer. Such a
`
`fabric layer is advantageous because it isolates the blood flow from the weakened vessel wall
`
`and therefore adding such a graft material to the stents of claim 11 of '508 would have been
`
`obvious to one of ordinary skill in the art.
`
`14.
`
`Regarding claim 2, see figs. 1-4 of Martin. Martin teaches that it is well known to form
`
`the first distal portion integrally with the proximal stent portion of a bifurcated stent assembly
`
`and therefore such a modification would have been obvious to one skilled in the art.
`
`15.
`
`16.
`
`Regarding claims 1 0 and 11, see fig. 1 of Martin.
`
`Claim 3 is rejected on the ground of nonstatutory obviousness-type double patenting as
`
`being unpatentable over claim 11 of U.S. Patent No. 5,800,508 in view of Chaikof as applied to
`
`claim 1 and further in view of Hess (US 5, 197,978). Claim 11 of '508 discloses the invention
`
`substantially as stated above including that the stent is made from a wire but fails to expressly
`
`disclose the use of a shape memory nitinol wire. Hess teaches manufacturing a self-expanding
`
`stent from a shape memory alloy such as nitinol (see abstract; col. 2 II. 20-35). Nitinol
`
`(nickel/titanium) is advantageous because it allows a stent to self expand once seated in the
`
`body and, thereafter, to be removed by heat recovery to its original, non-expanded
`
`configuration. It would have been obvious to one skilled in the art to have further modified claim
`
`11 of '508 in view of Hess to construct the stent out of nitinol so that it too may have the
`
`advantages associated with the use of a shape memory material.
`
`17.
`
`Claims 4, 5, 14, and 15 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 11 of U.S. Patent No. 5,800,508 in view of
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-9
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 9
`
`Chaikof as applied to claim 1 and further in view of Chuter (US 5,387,235). Claim 11 of '508
`
`discloses the invention substantially as stated above but fails to expressly disclose the claimed
`
`securing means.
`
`18.
`
`Chuter teaches forming a support frame for a bifurcated stent graft out of hoops (fig. 2)
`
`Chuter further teaches securing means for securing an apex of the sinuous wire in one hoop to
`
`a juxtaposed apex of a neighboring hoop so that each hoop is supported by its neighbors. The
`
`securing means taught by Chuter includes a loop element (58 for example; figs. 7, 8, 1 0) to tie
`
`the juxtaposed apices together (fig. 7). The securing means taught by Chuter, which includes
`
`flexibly secures several hoops to each other is advantageous because it adds the necessary
`
`strength to support a graft while still retaining flexibility through its securing means (58).
`
`Therefore, it would have been obvious to have further modified the device of claim 11 of '508 to
`
`include a loop element tying juxtaposed apices together as taught by Chuter so that it too may
`
`have this advantage.
`
`19.
`
`Claims 6 and 7 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claim 11 of U.S. Patent No. 5,800,508 in view of Chaikof
`
`as applied to claim 1 and further in view of Song (US 5,330,500). Claim 11 of '508 in view of
`
`Chaikof discloses the invention substantially as stated above but fails to disclose barbs that are
`
`covered by and project through the fabric of the graft layer. However, such a concept is known
`
`in the art. For example, Song discloses a stent with barbs (41 and 411) disposed thereon,
`
`wherein the stent is covered by a graft layer and portions 41 of the barbs, as well as the portions
`
`of 411 closest to the surface of the stent, are covered by the fabric and the remainder of
`
`portions 411 of the barbs extend through the graft so as to facilitate anchoring of the stent within
`
`the vessel (fig. 1 and 4; fig. 4 shows barbs extending through the graft 91, the barbs are labeled
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-10
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 10
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`in fig. 1 ). It would have been obvious to have added similar barbs to the device of claim 11 of
`
`'508 in view of Song in order to enhance anchoring of the stent within the vessel.
`
`20.
`
`Claim 16 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 7 of U.S. Patent No. 7,942,919 in view of Hillstead (US
`
`4,856,516). Claim 7 of '919 claims the invention of instant claim 16 substantially including a
`
`proximal stent portion ("endoluminal stent"), a first distal stent portion and an intermediate stent
`
`portion (tapering portions) and a second distal stent ("at least one distal prosthesis), the
`
`intermediate stent portion having a distal orifice at the distal end of at least one of the tapering
`
`portions which when in an expanded configuration forms a frustoconical female engaging
`
`portion serves to receive the male engaging portion having the frustoconical configuration of the
`
`distal stent completely within the female engaging portion of the orifice. Claim 7 of '919 also
`
`does not include that the stent portions comprise a plurality of hoops lying in planes
`
`perpendicular to the longitudinal axis, each of the hoops being formed of a substantially
`
`complete turn of a sinuous wire.
`
`21.
`
`Hillstead teaches constructing a stent such that it comprises a plurality of hoops which
`
`are axially displaced in a tubular configuration along a common axis, each of the hoops being
`
`formed by a substantially complete turn of a sinuous wire having apices and having a
`
`circumference that lies in a plane substantially perpendicular to the longitudinal axis of the stent.
`
`It would have been obvious to incorporate this stent structure into the stents of claim 7 of '919 in
`
`order to gain the advantages associated with this structure including a high degree of flexibility
`
`and a more direct and uniform application of expansion forces to the stent (see entire document,
`
`esp. col. 2, 11.14-25).
`
`22.
`
`Claims 17-20 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claim 7 of U.S. Patent No. 7,942,919 in view of Hillstead
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-11
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 11
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`as applied to claim 16 and further in view of Martin. Claim 7 of '919 discloses the invention
`
`substantially but fails to disclose the claimed graft layers as well as the first distal stent portion
`
`being formed integrally with the proximal stent portion.
`
`23.
`
`However, covering stents with graft material when treating aneurysms is well known in
`
`the art. For example, Martin teaches another bifurcated stent assembly and further discloses
`
`that the stents may be "entirely covered" by a graft (col. 3 II. 14-16) and therefore the graft on
`
`the inner surface of the intermediate portion (5) which forms the female cooperating portion may
`
`be considered the first graft layer and the graft covering the external surface of the second distal
`
`portion which forms the male engaging portion can be considered the second graft layer. Such a
`
`fabric layer is advantageous because it isolates the blood flow from the weakened vessel wall
`
`and therefore adding such a graft material to the stents of claim 7 of '919 would have been
`
`obvious to one of ordinary skill in the art.
`
`24.
`
`Claims 1 and 12 are rejected on the ground of nonstatutory obviousness-type double
`
`patenting as being unpatentable over claim 7 of U.S. Patent No. 7,942,919 in view of Chaikof
`
`and Hillstead. Claim 7 of '919 claims the invention of instant claims 1 and 12 substantially
`
`including a proximal stent portion ("endoluminal stent"), a first distal stent portion and an
`
`intermediate stent portion ("tapering portions") and a second distal stent ("at least one distal
`
`prosthesis), the intermediate stent portion having a distal orifice at the distal end of at least one
`
`of the tapering portions which when in an expanded configuration forms a frustoconical female
`
`engaging portion serves to receive the male engaging portion having the frustoconical
`
`configuration of the distal stent completely within the female engaging portion of the orifice.
`
`Claim 7 of '919 does not include that the proximal end of the proximal stent portion is flared
`
`radially outwardly towards it extremity and adapted to engage an endoluminal surface of the
`
`blood vessel. Claim 7 of '919 also does not include that the stent portions comprise a plurality of
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-12
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 12
`
`hoops lying in planes perpendicular to the longitudinal axis, each of the hoops being formed of a
`
`substantially complete turn of a sinuous wire.
`
`25.
`
`Chaikof teaches a stent apparatus comprising a bifurcated stent and a second stent
`
`wherein the bifurcated stent has a proximal stent portion which is generally cylindrical except for
`
`a flared proximal end (shown near ref. number 8 in fig. 6). This flared portion engages the
`
`endoluminal surface of the blood vessel as shown in figs. 4 and 5 for example and helps resist
`
`movement of the deployed stent (see also col. 4, II. 30-44). It would have been obvious to one
`
`skilled in the art to have modified the device of claim 7 of '919 to construct the proximal stent
`
`portion generally cylindrical except for a proximal end flare in order to improve the anchoring of
`
`the stent within the vessel as taught by Chaikof.
`
`26.
`
`Hillstead teaches constructing a stent such that it comprises a plurality of hoops which
`
`are axially displaced in a tubular configuration along a common axis, each of the hoops being
`
`formed by a substantially complete turn of a sinuous wire having apices and having a
`
`circumference that lies in a plane substantially perpendicular to the longitudinal axis of the stent.
`
`It would have been obvious to incorporate this stent structure into the stents of claim 7 of '919 in
`
`order to gain the advantages associated with this structure including a high degree of flexibility
`
`and a more direct and uniform application of expansion forces to the stent (see entire document,
`
`esp. col. 2, 11.14-25).
`
`27.
`
`Claims 2, 8-11, and 13 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 7 of U.S. Patent No. 7,942,919 in view of
`
`Chaikof and Hillstead as applied to claim 1 and further in view of Martin. Claim 7 of '919
`
`discloses the invention substantially but fails to disclose the claimed graft layers as well as the
`
`first distal stent portion being formed integrally with the proximal stent portion.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-13
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 13
`
`28.
`
`However, covering stents with graft material when treating aneurysms is well known in
`
`the art. For example, Martin teaches another bifurcated stent assembly and further discloses
`
`that the stents may be "entirely covered" by a graft (col. 3 II. 14-16) and therefore the graft on
`
`the inner surface of the intermediate portion (5) which forms the female cooperating portion may
`
`be considered the first graft layer and the graft covering the external surface of the second distal
`
`portion which forms the male engaging portion can be considered the second graft layer. Such a
`
`fabric layer is advantageous because it isolates the blood flow from the weakened vessel wall
`
`and therefore adding such a graft material to the stents of claim 7 of '919 would have been
`
`obvious to one of ordinary skill in the art.
`
`29.
`
`Regarding claim 2, see figs. 1-4 of Martin. Martin teaches that it is well known to form
`
`the first distal portion integrally with the proximal stent portion of a bifurcated stent assembly
`
`and therefore such a modification would have been obvious to one skilled in the art.
`
`30.
`
`31.
`
`Regarding claims 83 and 84, see fig. 1 of Martin.
`
`Claim 3 is rejected on the ground of nonstatutory obviousness-type double patenting as
`
`being unpatentable over claim 7 of U.S. Patent No. 7,942,919 in view of Chaikof and Hillstead
`
`as applied to claim 1 and further in view of Hess. Claim 7 of '919 discloses the invention
`
`substantially as stated above including that the stent is made from a wire but fails to expressly
`
`disclose the use of a shape memory nitinol wire. Hess teaches manufacturing a self-expanding
`
`stent from a shape memory alloy such as nitinol (see abstract; col. 2 II. 20-35). Nitinol
`
`(nickel/titanium) is advantageous because it allows a stent to self expand once seated in the
`
`body and, thereafter, to be removed by heat recovery to its original, non-expanded
`
`configuration. It would have been obvious to one skilled in the art to have further modified claim
`
`7 of '919 in view of Hess to construct the stent out of nitinol so that it too may have the
`
`advantages associated with the use of a shape memory material.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-14
`
`

`

`Application/Control Number: 13/601 ,902
`Art Unit: 3731
`
`Page 14
`
`32.
`
`Claims 4, 5, 14, and 15 are rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 7 of U.S. Patent No. 7,942,919 in view of
`
`Chaikof and Hillstead as applied to claims 1 and 12 above and further in view of Chuter. Claim 7
`
`of '919 discloses the invention substantially as stated above but fails to expressly disclose the
`
`claimed securing means.
`
`33.
`
`Chuter teaches forming a support frame for a bifurcated stent graft out of hoops (fig. 2)
`
`Chuter further teaches securing means for securing an apex of the sinuous wire in one hoop to
`
`a juxtaposed apex of a neighboring hoop so that each hoop is supported by its neighbors. The
`
`securing means taught by Chuter includes a loop element (58 for example; figs. 7, 8, 1 0) to tie
`
`the juxtaposed apices together (fig. 7). The securing means taught by Chuter, which includes
`
`flexibly secures several hoops to each other is advantageous because it adds the necessary
`
`strength to support a graft while still retaining flexibility through it