`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
`
`APPLICATION NO.
`
`13/603,937
`
`54953
`
`
`
`
` F ING DATE
`
`09/05/2012
`
`7590
`
`05/07/2013
`
`BROOKS, CAMERON & HUEBSCH, PLLC
`1221 NICOLLET AVENUE
`SUITE 500
`MINNEAPOLIS, MN 55403
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONF {MATION NO.
`
`George Goicoechea
`
`94— P0273US26
`
`2697
`
`EXAMINER
`
`HOLWERDA, KATHLEEN SONNETT
`
`ART UNIT
`
`3731
`
`MAIL DATE
`
`05/07/2013
`
`PAPER NUMBER
`
`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
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-1
`
`

`

`
`
`Applicant(s)
`Application No.
` 13/603,937 GOICOECHEA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`KATHLEEN HOLWERDA [SENS 3731
`
`-- The MAILING DA TE 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 3 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 1.136(a).
`In no event however may a reply be timely filed
`after SIX () 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. § 133).
`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 1 .704(b).
`
`Status
`
`1)IZI Responsive to communication(s) filed on 5 September 2012.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|ZI This action is non-final.
`2a)|:l This action is FINAL.
`3)I:I 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)|:| 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 Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)IZI Claim(s) 1-20 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|Z| Claim(s)_120 Is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* 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
`htt
`:/'I’vaIW.usnI‘.0. ovI’ atents/init events/
`
`
`
`hI/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)IZI The specification is objected to by the Examiner.
`11)I:l The drawing(s) filed on
`is/are: a)I:I accepted or b)I:I 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)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some * c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| 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.
`
`Interim copies:
`
`a)|:l All
`
`b)I:I Some
`
`c)I:I None of the:
`
`Interim copies of the priority documents have been received.
`
`Attachment(s)
`
`1) E Notice of References Cited (PTO-892)
`
`3) D Interview Summary (PTO-413)
`
`Paper N°ISI/Ma" Date' —
`PTO/SB/08
`t
`t
`St
`I
`D'
`I'
`f
`2 I] I
`)
`4) I:I Other:
`a emen (s) (
`Isc osure
`n orma Ion
`)
`Paper No(s)/Mai| Date W.L. Gore & Associates, Inc.
`
`U.S. Patent and Trademark Office
`X 1 1t
`-
`PTOL—326 (Rev. 03-13)
`Part of Paper No./Mai| Date 20130503
`
`Office Action Summary
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-2
`
`

`

`Application/Control Number: 13/603,937
`
`Page 2
`
`Art Unit: 3731
`
`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 all 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 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 10.23. 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.
`
`2.
`
`Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
`
`under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or
`
`more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
`
`3.
`
`This application has been filed as a continuation of US Application No. 08/461,402, filed
`
`June 5, 1995. 35 USC 120 requires an application for patent be "filed by an inventor or
`
`inventors named in the previously filed application..." At this time, it appears that 08/461,402
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-3
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-3
`
`

`

`Application/Control Number: 13/603,937
`
`Page 3
`
`Art Unit: 3731
`
`had an inventive entity of “Cragg and Dake”. However, the instant application has an inventive
`
`entity of "Goicoechea, Hudson, and Mialhe". As there is not at least one inventor named in this
`
`application named in application '402I applicants are not entitled to the priority claim made in the
`
`instant specification and ADS filed 9/5/2012. Therefore, the specification is objected to, and
`
`applicants are required to correct the claim for priority found in the specification. Therefore, the
`
`earliest priority date of this application is 9/5/2012.
`
`4.
`
`It is further noted that the power of attorney filed 9/5/2012 includes Andrew Cragg as an
`
`inventor even though his name does not appear in the ADS filed 9/5/2012 or the oath filed
`
`9/5/2012.
`
`Claim Objections
`
`5.
`
`Claims 1, 2, 4-6, 10, 14-16 and 20 are objected to because of the following informalities:
`
`a.
`
`Claim 1: in lines 6-7, insert “of the at least one distal stent” after “on the proximal
`
`end“
`
`b.
`
`0.
`
`Claim 2: insert "inclined" between "short" and "extension" in the last line.
`
`Claims 4-6: Replace “the distal stent” with “the at least one distal stent" in lines 2
`
`and 3 of claim 4, lines 2, 5, and 6 of claim 5, lines 4-5 of claim 6.
`
`d.
`
`3.
`
`e.
`
`Claim 10: insert “of the proximal and distal stents” between “ends” and “to” in line
`
`Claim 14: in line 9, insert “of the distal stents” after “the distal end” in orderto
`
`clarify which distal end is being referred to.
`
`f.
`
`Claim 15: it is suggested that “the distal end and” be removed as this portion of
`
`the limitation is redundant as it already appears in claim 14.
`
`g.
`
`Claim 16: insert “of the proximal and distal stents" after "respective distal ends" in
`
`line 3 of the claim.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-4
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-4
`
`

`

`Application/Control Number: 13/603,937
`
`Page 4
`
`Art Unit: 3731
`
`h.
`
`i.
`
`Claim 20: "orifice” in the last line should read “orifices”.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 1 12
`
`6.
`
`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-AIA), 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.
`
`7.
`
`Claims 1-8, 11, 12, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-
`
`AIA), 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-AIA the applicant regards as
`
`the invention.
`
`8.
`
`Claim 1: lines 12-13 include that the proximal stent has "at least one distal orifice at a
`
`distal end of at least one of the tapering portions". This limitation includes one tapering portion
`
`with multiple distal orifices, which is not supported by the specification. It appears that lines 12-
`
`13 should read "the proximal stent also having a distal orifice at a distal end of at least one of
`
`the tapering portions". This allows for a distal orifice at the end of one or both of the tapering
`
`portions, which reflects the actual invention. Such a change will necessitate that “the at least
`
`one distal orifice” in lines 30 and 33 of claim 1 and line 3 of claim 3 be amended to read “the
`
`distal orifice” as well.
`
`9.
`
`Claim 2: in line 6, "the distal stent having the proximal end" should read "the proximal
`
`end of the distal stent" since multiple proximal ends are claimed and such an amendment
`
`clarified which proximal end is being referred to.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-5
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-5
`
`

`

`Application/Control Number: 13/603,937
`
`Page 5
`
`Art Unit: 3731
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`10.
`
`Claim 5: “the stent” in line 3 lacks antecedent basis as it is unclear which stent is being
`
`referred to.
`
`11.
`
`Claims 6, 7, and 8: in lines 1-2, “the distal stents” lacks antecedent basis. The claim
`
`should read “the at least one distal stent”.
`
`12.
`
`Claim 11: “the at least one distal stent" in lines 1-2 lacks antecedent basis. It is noted
`
`that claim 9 includes "first and second distal stents". Therefore, lines 1-2 of claim 11 should read
`
`“the first and second distal stents”.
`
`13.
`
`Claim 12: “the at least one distal orifice" in lines 1-2 and 4 lacks antecedent basis. Claim
`
`9 claims "the distal orifice" and therefore lines 1-2 and 4 of claim 12 should read "the distal
`
`orifice”.
`
`14.
`
`Claim 17: “the at least one distal stent” lacks antecedent basis. Since claim 14 includes
`
`“a pair of distal stents ,
`
`the at least one distal stent” in lines 2-3 should be replace with “the pair
`
`of distal stents”.
`
`Double Patenting
`
`15.
`
`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 Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re
`
`Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thoringfon, 418 F.2d 528, 163
`
`USPQ 644 (CCPA 1969).
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-6
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-6
`
`

`

`Application/Control Number: 13/603,937
`
`Page 6
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`Art Unit: 3731
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`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).
`
`16.
`
`Claims 9-11 and 14-19 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. Claim 11 of
`
`‘508 claims the invention of claims 9-11 and 14-19 substantially including a proximal stent
`
`("endoluminal stent") having two transversely placed tapering portions ("at least one additional
`
`stent segment of frustoconical shape”) and at least one distal stent (“additional stent segment
`
`having mating frustoconical shape”; see claims 9 and 10), the proximal stent having at least one
`
`distal orifice at the distal end of at least one of the tapering portions which when in an expanded
`
`configuration 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 10). The proximal stent and the tapering portions comprise a plurality of hoops which are
`
`axially displaced in a tubular configuration along a common axis, each of the hoops being
`
`formed of 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,
`
`the apices of adjacent hoops juxtaposed together and at least two juxtaposed apices connected
`
`by a securing means which may be suture (see claims 1 and 2). Therefore, claims 9-11 and 14-
`
`19 are "anticipated” by claim 11 of ‘508.
`
`17.
`
`Claim 13 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 Chuter (US
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-7
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-7
`
`

`

`Application/Control Number: 13/603,937
`
`Page 7
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`Art Unit: 3731
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`5,562,726). Claim 11 of ‘508 discloses the invention substantially but does not disclose securing
`
`the proximal and distal stents with suture. However, Chuter discloses that it is well known to use
`
`suture to attach distal graft legs to a bifurcated proximal graft (see figs. 28 and 29). It would
`
`have been obvious to one skilled in the art to have further modified the device of claim 11 of
`
`‘508 to include securing the proximal and distal stents with suture as taught by Chuter to provide
`
`additional means of preventing the stents and graft material from separating.
`
`18.
`
`Claims 1-4, 6-8, 12, and 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 claims the invention of claims 1-4, 6-8, 12, and 20
`
`substantially including a proximal stent having two transversely placed tapering portions and at
`
`least one distal stent (see claims 9 and 10), the proximal stent having at least one distal orifice
`
`at the distal end of at least one of the tapering portions which when in an expanded
`
`configuration 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 10). The proximal stent and the tapering portions comprise a plurality of hoops which are
`
`axially displaced in a tubular configuration along a common axis, each of the hoops being
`
`formed of 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,
`
`the apices of adjacent hoops juxtaposed together and at least two juxtaposed apices connected
`
`by a securing means (see claims 1 and 2). Claim 11 of ‘508 does not include that a cross-
`
`sectional area (“CSA”) of the distal orifice when expanded is sufficiently less than that of the
`
`proximal end of the at least one distal stent when expanded within the distal orifice so as to
`
`secure together the two stents. However, claim 11 includes that the two frustoconical shapes
`
`mate together when one of them is expanded. Martin discloses a similar arrangement of two
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-8
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-8
`
`

`

`Application/Control Number: 13/603,937
`
`Page 8
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`Art Unit: 3731
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`mating stents wherein one of the stents is expanded within the other in order to secure them
`
`together (col. 3, II. 29-36). Martin teaches that a larger CSA allows for a friction fit when one of
`
`the stents expands within the other. It would have been obvious to have modified the device of
`
`claim 11 of '508 to include such a feature in order to enhance securement between the two
`
`mating segments.
`
`19.
`
`Regarding claims 2 and 3, although claim 11 of ‘508 uses different designations for the
`
`different portions of the bifurcated stent assembly, it is clear from claim 11 that the distal stent
`
`has a proximal end which when expanded will at least partially secure with the short extension
`
`forming one of the tapered portions.
`
`20.
`
`Regarding claim 4, see platinum wire (12) of Martin. It would have been obvious to have
`
`added a similar wire to the device of claim 11 of ‘508 in order to facilitate viewing of the device.
`
`21.
`
`Regarding claims 6 and 7, claim 11 of ‘508 includes that the stent assembly is used to
`
`treat a bifurcated artery but does not expressly disclose that the proximal stent defines two
`
`lumens, at least one of which is configured to be disposed entirely within the vessel and is
`
`adapted to secure to the distal stent configured to extend into one of the two branched vessels.
`
`However, Martin teaches that such a placement of a bifurcated stent assembly is known in order
`
`to ensure that blood flows in an uninterrupted manner between the main vessel and the
`
`branching vessels (see figs. 1-4). It would have been obvious to one skilled in the art to have
`
`modified the device of claim 11 of '508 to have the capability of such placement as taught by
`
`Martin in order to facilitate blood flow at a bifurcation. As to claim 7, as discussed above in more
`
`detail, claim 11 of ‘508 includes frustoconical mating sections.
`
`22.
`
`Regarding claim 8, claim 11 of’ ’508 does not include a fabric layer on any of the stents.
`
`However, Martin teaches including a fabric layer over a bifurcated stent assembly in order to
`
`treat aneurysms at a bifurcation. In particular, providing a fabric layer isolates the blood flow
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-9
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-9
`
`

`

`Application/Control Number: 13/603,937
`
`Page 9
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`Art Unit: 3731
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`from the walls of the compromised blood vessel. It would have been obvious to one skilled in
`
`the art to have added a fabric layer to the device of claim 11 of ‘508 in order the vessel wall from
`
`blood flowing through the stent assembly thereby allowing treatment of an aneurysm.
`
`23.
`
`Claim 5 is rejected on the ground of nonstatutory obviousness-type double patenting as
`
`being unpatentable over claim 11 of US. Patent No. 5,800,508 in view of Martin as applied to
`
`claim 1 above and further in view of Liebig (US 3,805,301). Claim 11 of ‘508 is silent on the
`
`claimed radiographic indicia. Liebig teaches that it is well known to provide markers along the
`
`longitudinal axis of a stent such that the rotational orientation affects the shape of the marker
`
`(see abstract). In particular, if the graft is twisted at all, the marker will be twisted. It would have
`
`been obvious to provide radiographic indicia in the form of a wire attached in a longitudinal
`
`manner as taught by Liebig on the device of claim 11 of ‘508 so that any twisting of the stent
`
`structure can be easily determined by viewing the marker. With this modification, the
`
`radiographic image of the radiographic indicia varies with rotational orientation of the stent.
`
`24.
`
`Claims 9, 10, 12, 14-16, and 20 are rejected on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claim 7 of US. Patent No.
`
`7,942,919. Claim 7 of ‘919 claims the invention of claims 9, 10, 12, 14-16 and 20 substantially
`
`including a proximal stent having two transversely placed tapering portions and at least one
`
`distal stent, the proximal stent having at least one distal orifice at the distal end of at least one of
`
`the tapering portions which when in an expanded configuration serves to receive the male
`
`engaging portion having the frustoconical configuration of the distal stent within the female
`
`engaging portion of the orifice. Regarding clams 12 and 20, a cross-sectional area (“CSA”) of
`
`the distal orifice when expanded is sufficiently less than that of the proximal end of the at least
`
`one distal stent when expanded within the distal orifice so as to secure together the two stents.
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-10
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-10
`
`

`

`Application/Control Number: 13/603,937
`
`Page 10
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`Art Unit: 3731
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`Claim 7 of ‘919 discloses that the stents comprise a fabric layer and wire skeletons of an
`
`expandable stent.
`
`25.
`
`Claim 13 is rejected on the ground of nonstatutory obviousness-type double patenting
`
`as being unpatentable over claim 7 of US. Patent No. 7,942,919 in view of Chuter. Claim 7 of
`
`‘919 discloses the invention substantially but does not disclose securing the proximal and distal
`
`stents with suture. However, Chuter discloses that it is well known to use suture to attach distal
`
`graft legs to a bifurcated proximal graft (see figs. 28 and 29). It would have been obvious to one
`
`skilled in the art to have further modified the device of claim 7 of ‘919 to include securing the
`
`proximal and distal stents with suture as taught by Chuter to provide additional means of
`
`preventing the stents and graft material from separating.
`
`26.
`
`Claims 1-3, 11, and 17-19 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 (US 4,856,516) and Cottone, Jr. (US 5,549,663; “Cottone”). Claim 7 of ‘919 claims the
`
`invention of claims 1-3, 11, and 17-19 substantially including a proximal stent having two
`
`transversely placed tapering portions and at least one distal stent, the proximal stent having at
`
`least one distal orifice at the distal end of at least one of the tapering portions which when in an
`
`expanded configuration serves to receive the male engaging portion having the frustoconical
`
`configuration of the distal stent within the female engaging portion of the orifice. A cross-
`
`sectional area (“CSA”) of the distal orifice when expanded is sufficiently less than that of the
`
`proximal end of the at least one distal stent when expanded within the distal orifice so as to
`
`secure together the two stents. Claim 7 of ‘919 discloses that the stents comprise a fabric layer
`
`and wire skeletons of an expandable stent but fails to disclose that the stents comprise a
`
`plurality of hoops which are axially displaced in a tubular configuration along a common axis,
`
`each of the hoops being formed of a substantially complete turn of a sinuous wire having apices
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-11
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-11
`
`

`

`Application/Control Number: 13/603,937
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`Page 11
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`Art Unit: 3731
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`and having a circumference that lies in a plane substantially perpendicular to the longitudinal
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`axis of the stent, the apices of adjacent hoops juxtaposed together and at least two juxtaposed
`
`apices connected by a securing means (see claims 1 and 2).
`
`27.
`
`However, 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
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`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
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`stent. It would have been obvious to incorporate this stent structure into the stents of claim 7 of
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`‘919 in order to gain the advantages associated with this structure including a high degree of
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`flexibility and a more direct and uniform application of expansion forces to the stent (see entire
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`document of Hillstead, esp. col. 2,
`
`II. 14-25). Hillstead fails to disclose that the apices of
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`adjacent hoops are juxtaposed to one another and at least two juxtaposed apices are connected
`
`by a securing means. Cottone teaches providing wire hoops which are out of phase such that
`
`apices of adjacent hoops are juxtaposed to one another and are connected by a securing
`
`means (weld point 18). These securing means are advantageous because, when applied at
`
`least to end portions of the stent, they provide anchoring portions within the stent which possess
`
`greater hoop strength than un-welded end portions, thereby making less likely unintentional
`
`movement of the stent after deployment (col. 1, II. 20-24; col. 4, II. 48-64). It would have been
`
`obvious to incorporate such a securing means as taught by Cottone into the device of claim 7 of
`
`‘919 in view of Hillstead so that it too may have this advantage.
`
`28.
`
`Regarding claims 2 and 3, see claim 7 of ‘919.
`
`29.
`
`Claims 4 and 6-8 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
`
`and Cottone, Jr. as applied to claim 1 above and further in view of Martin (US 5,575,817).
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-12
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-12
`
`

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`Application/Control Number: 13/603,937
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`Page 12
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`Art Unit: 3731
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`Regarding claim 4, claim 7 of ‘919 fails to disclose a portion of different radiopacity. Martin
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`teaches another bifurcated stent assembly and further teaches including a platinum wire (12) in
`
`order to increase radiopacity. It would have been obvious to have added a similar wire to the
`
`device of claim 7 of ‘919 in order to facilitate viewing of the device.
`
`30.
`
`Regarding claims 6 and 7, claim 7 of ‘919 includes that the proximal prosthesis forms a
`
`bifurcated prosthesis but does not expressly disclose that the proximal stent defines two
`
`lumens, at least one of which is configured to be disposed entirely within the vessel and is
`
`adapted to secure to the distal stent configured to extend into one of the two branched vessels.
`
`However, Martin teaches that such a placement of a bifurcated stent assembly is known in order
`
`to ensure that blood flows in an uninterrupted manner between the main vessel and the
`
`branching vessels (see figs. 1-4). It would have been obvious to one skilled in the art to have
`
`modified the device of claim 7 of ‘919 to have the capability of such placement as taught by
`
`Martin in order to facilitate blood flow at a bifurcation. As to claim 7, as discussed above in more
`
`detail, claim 7 of ‘919 includes frustoconical mating sections.
`
`31.
`
`Regarding claim 8, claim 7 of ‘919 includes that the stents have a fabric layer over the
`
`stent structure.
`
`32.
`
`Claim 5 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 and Cottone,
`
`Jr. as applied to claim 1 above and further in view of Liebig. Claim 7 of ‘919 is silent on the
`
`claimed radiographic indicia. Liebig teaches that it is well known to provide markers along the
`
`longitudinal axis of a stent such that the rotational orientation affects the shape of the marker
`
`(see abstract). In particular, if the graft is twisted at all, the marker will be twisted. It would have
`
`been obvious to provide radiographic indicia in the form of a wire attached in a longitudinal
`
`manner as taught by Liebig on the device of claim 7 of '919 so that any twisting of the stent
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-13
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-13
`
`

`

`Application/Control Number: 13/603,937
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`Page 13
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`Art Unit: 3731
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`structure can be easily determined by viewing the marker. With this modification, the
`
`radiographic image of the radiographic indicia varies with rotational orientation of the stent.
`
`33.
`
`Claims 9, 10, and 14-18 are provisionally rejected on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claim 1 of copending Application
`
`No. 13/601,902. Claim 1 of ‘902 claims the invention of instant claims 9, 10, and 14-18
`
`substantially including a bifurcated stent assembly comprising a proximal stent and a distal stent
`
`wherein the proximal stent and distal stent are joined together by frustoconically shaped
`
`engaging male and female portions. Claim 1 of '902 also includes that the stents are formed by
`
`wire hoops which are perpendicular to the longitudinal axis of the stent. Although claim 1 of ‘902
`
`does not include that the proximal end of the proximal stent has a proximal orifice as claimed in
`
`instant claim 15, such a modification would have been well within the purview of one skilled in
`
`the art since stents are known to have openings at either end to facilitate blood flow
`
`therethrough.
`
`34.
`
`Claim 11 and 19 are provisionally rejected on the ground of nonstatutory obviousness-
`
`type double patenting as being unpatentable over claim 1 of copending Application No.
`
`13/601,902 in view of Cottone, Jr. Claim 1 of ‘902 claims the invention of instant claims 9 and
`
`14 substantially including a bifurcated stent assembly comprising a proximal stent and a distal
`
`stent wherein the proximal stent and distal stent are joined together by frustoconically shaped
`
`engaging male and female portions. Claim 1 of '902 also includes that the stents are formed by
`
`wire hoops which are perpendicular to the longitudinal axis of the stent. Claim 1 of ‘902 fails to
`
`disclose that the wire is sinuous with adjacent apices juxtaposed and connected by a securing
`
`means. Cottone teaches providing wire hoops which are out of phase such that apices of
`
`adjacent hoops are juxtaposed to one another and are connected by a securing means (weld
`
`point 18). These securing means are advantageous because, when applied at least to end
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-14
`
`W.L. Gore & Associates, Inc.
`Exhibit 1012-14
`
`

`

`Application/Control Number: 13/603,937
`
`Page 14
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`Art Unit: 3731
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`portions of the stent, they provide anchoring portions within the stent which possess greater
`
`hoop strength than un-welded end portions, thereby making less likely unintentional movement
`
`of the stent after deployment (col. 1,
`
`II. 20-24; col. 4, II. 48-64). It would have been obvious to
`
`have used a sinuous wire with a securing means as taught by Cottone into the device of claim 1
`
`of ‘902 so that it too may have this advantage.
`
`35.
`
`Claim 12 and 20 are provisionally rejected on the ground of nonstatutory obviousness-
`
`type double patenting as being unpatentable over claim 1 of copendin