UNITED STAlES P A lENT 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.
`
`08/312,881
`
`09/27/1994
`
`ANDREW CRAGG
`
`94-P0272USO 1
`
`1273
`
`7590
`54953
`03/25/2010
`BROOKS, CAMERON & HUEBSCH, PLLC
`1221 NICOLLET A VENUE
`SUIlE 500
`MINNEAPOLIS, MN 55403
`
`EXAMINER
`
`SONNETT, KATHLEEN C
`
`ART UNIT
`
`PAPER NUMBER
`
`3731
`
`MAIL DATE
`
`03/25/2010
`
`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 1013-1
`
`

`

`Office Action Summary
`
`Application No.
`
`08/312,881
`
`Examiner
`
`Applicant(s)
`
`CRAGG ET AL.
`
`Art Unit
`
`3731
`KATHLEEN SONNETT
`-- 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 ~ 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, maya 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. § 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)1ZI Responsive to communication(s) filed on 17 December 2009.
`2a)0 This action is FINAL.
`2b)1ZI This action is non-final.
`3)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 Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`4)1ZI Claim(s) 1,2.4-12,63,64.77-81,83 and 84 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)1ZI Claim(s) 1,2.4-12,63,64.77-81,83 and 84 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`9)1ZI The specification is objected to by the Examiner.
`10)1ZI The drawing(s) filed on 08 October 1998 is/are: a)O accepted or b)1ZI 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).
`11)1ZI The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`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.
`
`4) 0 Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`Attachment(s)
`1) IZI Notice of References Cited (PTO-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) IZIlnformation Disclosure Statement(s) (PTO/SS/08)
`Paper No(s)/Mail Date See Continuation Sheet.
`U.s. Patent and Trademark Office
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
`
`Part of Paper No.lMail Date 20100304
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-2
`
`

`

`Continuation Sheet (PTOL-326)
`
`Application No. 08/312,881
`
`Continuation of Attachment(s) 3). Information Disclosure Statement(s) (PTO/SB/08), Paper No(s)/Mail Date
`:7/811996,3/16/1999,4/27/2001 ,8/4/2006,5/412009,5/13/2009.
`
`2
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-3
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 2
`
`DETAILED ACTION
`
`Continued Examination
`
`1.
`
`The last action on the merits in this application was a notice of allowance mailed
`
`February 20,1997 for Claims 1, 2, 4-17, 38, 63, 64, 66, 68-71, 73-81, 83 and 84. A notice of
`
`allowance is considered to be a prosecution closing action. Subsequent to that notice,
`
`applicants sought in a paper filed under 37 CFR 1.312 on May 20, 1997 to withdraw the
`
`application from issue in order to provoke an interference with Martin's U.S. patent # 5,575,817.
`
`On October 15, 1998, applicants sought to substitute this application into Interference No.
`
`104,192 (see paper of that date). It is noted that the paper mailed 1/31/2003 was improper and
`
`is considered withdrawn.
`
`2.
`
`Applicants have submitted a communication on April 29, 2009 summarizing the status of
`
`the application, claims, interference matters, etc. However, a review of the application has
`
`revealed some variance in the record, which has been addressed below.
`
`Power of Attorney
`
`3.
`
`The Office notes with appreciation the updated power of attorney and statement under
`
`37 CFR 3.73(b) filed on December 17,2009, which clarifies the chain of title.
`
`Interference
`
`4.
`
`The following is a summary of the count for Interference No.1 04,192, which involved
`
`another application related to this application.
`
`5.
`
`Interference No.1 04,192 determined priority related to Count 2, which read:
`
`An apparatus for reinforcing a bifurcated lumen comprising:
`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, and further comprising a second section
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-4
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 3
`
`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.
`
`6.
`
`A review of the Board's opinion rendered on July 27, 2001 in Interference No.1 04, 192
`
`suggests that some of the claims in this application may be readable on the count from that
`
`interference. Starting on page 55 (and later on page 62 et seq.), the Board discusses the
`
`language of Claim 59 from application 08/461,402. It appears that pending Claim 80 in the
`
`instant application contains the same claimed invention (the additional feature of "a graft layer"
`
`is considered a feature that is rendered obvious) as Claim 59 from '402. As applicants were the
`
`losing party in I nterference No.1 04, 192, they are "barred on the merits from seeking a claim
`
`that would have been anticipated or rendered obvious by the subject matter of the lost count."
`
`See MPEP 2308.03.
`
`7.
`
`In applicants' filing under 37 CFR 1.312 on May 20, 1997, the following statement was
`
`made:
`
`Applicants are requested to review this statement in light of the prosecution and interference
`
`history for all of its related applications. Applicants are requested to state if this application was
`
`part of an interference count and identify which claims from this application were part of any
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-5
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 4
`
`interference count, if any. Applicants are also to cancel claims in this application in accordance
`
`with this statement made on May 20, 1997.
`
`Priority
`
`8.
`
`From a review of the interference papers and CAFC decision for Interference No.
`
`104,192, applicants have lost the right to claim the benefit of EP 94400284.9 and EP
`
`94401306.9. Therefore, for the purposes of this Office action, applicants' filing date of
`
`September 27, 1994 will be used for determining applicable prior art.
`
`Oath/Declaration
`
`9.
`
`The oath or declaration is defective. A new oath or declaration in compliance with 37
`
`CFR 1.67(a) identifying this application by application number and filing date is required. See
`
`MPEP §§ 602.01 and 602.02.
`
`The oath or declaration is defective because:
`It identifies foreign applications for patent or inventor's certificate on which priority is
`claimed pursuant to 37 CFR 1.55 to which applicants are not entitled to make.
`
`In ventorship
`
`10.
`
`On September 27, 1994, applicants requested a change in the order of the names for
`
`the inventorship despite the order listed in the oath filed on the same day. In the oath submitted
`
`September 27, 1994, the first named inventor was Cragg. All applicants signed the same oath
`
`(i.e., there were not separate oaths). Applicants requested the names be reordered so that
`
`inventor Goicoechea was listed first in the Office's records.
`
`11.
`
`To compound the order of inventorship problem, on January 24, 1997, applicants filed a
`
`petition under 37 CFR 1.48, and each newly submitted oath listed each inventor as the first
`
`named inventor on each respective oath.
`
`12.
`
`Throughout the prosecution history, applicants have styled their filings with either Cragg
`
`or Goicoechea as the first named inventor. Applicants are advised that the Office considers the
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-6
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 5
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`inventorship to be Cragg et al. because the September 27, 1994 was not considered to be a
`
`petition under 37 CFR 1.182 and the request to reorder the named inventorship has not been
`
`granted. For further guidance on the order of names in applications, applicants should review
`
`MPEP 605.04(f).
`
`13.
`
`On April 15, 1997, the petition to correct inventorship to add Michael Oake was granted.
`
`In light of the inventorship changes in the related applications involved in various interferences,
`
`applicants are requested to confirm this application reflects the proper inventorship for pending
`
`Claims 1, 2, 4-17, 38, 63, 64, 66, 68-71, 73-81, 83 and 84.
`
`Response to Amendment
`
`14.
`
`Applicants have filed an amendment on April 29, 2009 amending claims 9,64, 77-79.
`
`Information Disclosure Statement
`
`15.
`
`Applicants filed two supplemental information disclosure statements on May 4, and May
`
`13, 2009 and have summarized the status of earlier submitted lOS's on page 4 of the
`
`Communication filed April 29, 2009.
`
`16.
`
`A review of the application papers reveals a communication from applicants dated 8/4/06
`
`that states an lOS was filed on 8/18/04 was not of record. Applicants resubmitted the missing
`
`lOS on 8/4/06.
`
`17.
`
`An lOS dated 7/8/96 was initialed by the examiner, but was not included in the final
`
`rejection mailed 8/23/96. A copy of this lOS has been attached to this action.
`
`18.
`
`There have been five information disclosure statements submitted since the Notice of
`
`Allowance was mailed on February 20,1997: March 16,1999, April 27, 2001, and August 4,
`
`2006 (the resubmitted 8/18/04 paper), May 5, 2009, and May 13, 2009.
`
`19.
`
`It appears that applicants' submissions comply with 37 CFR 1.97 and 1.98. However, the
`
`lOS filed 4/27/2001 includes an entry that has not been considered and has been lined through
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-7
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 6
`
`on the initialed 1449, and will not be admitted unless the requirements for 37 CFR 1.91 are
`
`satisfied. Applicants are advised to review the guidance found in the MPEP 608.03.
`
`Election/Restrictions
`
`20.
`
`On August 1, 1995, applicants received a restriction requirement. Applicants elected
`
`without traverse on August 24, 1995 to prosecute Group I drawn to a bifurcated stent or stent-
`
`graft. That restriction requirement still remains a part of the pending application.
`
`Abstract
`
`21.
`
`The abstract of the disclosure is objected to because it contains legal terminology "said"
`
`and "means". On line 5, there appears to be a typographical error. The abstract should also be
`
`revised to shorten the text as so as to comply with 37 CFR 1.72(b). Correction is required. See
`
`MPEP § 608.01 (b).
`
`Drawings
`
`22.
`
`The drawings are objected to under 37 CFR 1.83(a) because they fail to show graft layer
`
`or woven fabric or barbs as described in the specification. Any structural detail that is essential
`
`for a proper understanding of the disclosed invention should be shown in the drawing. MPEP §
`
`608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121 (d) are required in reply
`
`to the Office action to avoid abandonment of the application. Any amended replacement
`
`drawing sheet should include all of the figures appearing on the immediate prior version of the
`
`sheet, even if only one figure is being amended. The figure or figure number of an amended
`
`drawing should not be labeled as "amended." If a drawing figure is to be canceled, the
`
`appropriate figure must be removed from the replacement sheet, and where necessary, the
`
`remaining figures must be renumbered and appropriate changes made to the brief description of
`
`the several views of the drawings for consistency. Additional replacement sheets may be
`
`necessary to show the renumbering of the remaining figures. Each drawing sheet submitted
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-8
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 7
`
`after the filing date of an application must be labeled in the top margin as either "Replacement
`
`Sheet" or "New Sheet" pursuant to 37 CFR 1.121 (d). If the changes are not accepted by the
`
`examiner, the applicant will be notified and informed of any required corrective action in the next
`
`Office action. The objection to the drawings will not be held in abeyance.
`
`23.
`
`The drawings are objected to under 37 CFR 1.83(a). The drawings must show every
`
`feature of the invention specified in the claims. Therefore, the blood vessel (Claims 1, 63, 77,
`
`78, 79), a diameter greater than the blood vessel (Claims 5, 78, 79), the perpendicular /square
`
`orientation (Claims 6, 8), a complete turn of wire (Claim 7), securing means (claims 9-10), a
`
`female portion on the intermediate stent / a male portion on the second stent (Claim 11), a radial
`
`flare (Claim 12), a graft layer (Claims 63,80-81,83,84), bio-compatible fabric (Claim 63), barbs
`
`(Claim 63) that extend through fabric (Claim 64), dimensions relative to vessels (Claim 77), the
`
`inward taper of Claim 77, and a graft layer disposed both internally and externally (Claim 84)
`
`must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
`
`Corrected drawing sheets in compliance with 37 CFR 1.121 (d) are required in reply to
`
`the Office action to avoid abandonment of the application. Any amended replacement drawing
`
`sheet should include all of the figures appearing on the immediate prior version of the sheet,
`
`even if only one figure is being amended. The figure or figure number of an amended drawing
`
`should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure
`
`must be removed from the replacement sheet, and where necessary, the remaining figures
`
`must be renumbered and appropriate changes made to the brief description of the several views
`
`of the drawings for consistency. Additional replacement sheets may be necessary to show the
`
`renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an
`
`application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet"
`
`pursuant to 37 CFR 1.121 (d). If the changes are not accepted by the examiner, the applicant
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-9
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 8
`
`will be notified and informed of any required corrective action in the next Office action. The
`
`objection to the drawings will not be held in abeyance.
`
`24.
`
`The drawings are objected to because
`
`• Figure 2 should have a label for element "12". Figures 5-7 are described as
`
`having a fabric graft layer, but elsewhere in the specification, the graft layer is
`
`described as not being shown.
`
`• Figures 5-7 fail to properly represent a fabric layer with the typical drawing
`
`symbols specified in MPEP 608.02 for fabric.
`
`• Figure 6 fails to show a radial flare (see description on p. 27)
`
`•
`
`It is also not clear as to whether Figure 6 is showing a fabric layer disposed
`
`internally or not (see description on page 28). The ends of element 78, 80 and
`
`86 appear to have a capped end rather than showing the interior.
`
`• Figure 7, element 110 is not flared as described on page 29.
`
`25.
`
`Corrected drawing sheets in compliance with 37 CFR 1.121 (d) are required in reply to
`
`the Office action to avoid abandonment of the application. Any amended replacement drawing
`
`sheet should include all of the figures appearing on the immediate prior version of the sheet,
`
`even if only one figure is being amended. The figure or figure number of an amended drawing
`
`should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure
`
`must be removed from the replacement sheet, and where necessary, the remaining figures
`
`must be renumbered and appropriate changes made to the brief description of the several views
`
`of the drawings for consistency. Additional replacement sheets may be necessary to show the
`
`renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an
`
`application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet"
`
`pursuant to 37 CFR 1.121 (d). If the changes are not accepted by the examiner, the applicant
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-10
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 9
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`will be notified and informed of any required corrective action in the next Office action. The
`
`objection to the drawings will not be held in abeyance.
`
`Specification
`
`26.
`
`In reviewing the applicants' "Communication in Response to Notice under 37 CFR
`
`1.251" there is some inconsistency about the summary for reconstruction papers. In that table,
`
`applicants listed the application transmittal as being dated October 4, 1994. However, the
`
`scanned image of the file wrapper for 08/312,881 shows a filing date of September 27, 1994.
`
`There are also other papers of record in the I FW dated September 27, 1994.
`
`27.
`
`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) in the first paragraph of the specification is acknowledged.
`
`However, 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:
`
`The specification filed on October 4, 1994 is objected to because it states this
`
`application (08/312,881) is a continuation in part of another application for which a serial
`
`number has not been provided. In addition, two separate oaths, one filed on September
`
`27, 1994 and the other filed January 24, 1997 (accompanying the petition under 37 CFR
`
`1.48) fail to list any claim for benefit under 35 U .S.C. 120.
`
`28.
`
`It is requested that applicants confirm which specification is the intended specification for
`
`this application. The specification dated October 4, 1994 does not appear to be a proper
`
`substitute specification, and may be a specification for a different application introduced when
`
`this application was reconstructed October 7, 2002.
`
`29.
`
`The disclosure is objected to because of the following informalities:
`
`• On page 7, line 3, "angeological" is a misspelling;
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-11
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 10
`
`• On page 19, 20a and 20b should not be written with superscripts (lines 16 and
`
`19);
`
`• On page 28, line 5, "immediate" should be -intermediate--;
`
`• On page 28, element 88 is described as the "male engaging portion" and element
`
`78 is described as the "female cooperating portion." This description is opposite
`
`to the configuration shown in Figure 6, for example.
`
`Appropriate correction is required.
`
`Petition to Expunge
`
`30.
`
`Applicants are advised to review 37 CFR 1.59 and MPEP 724.05 for guidance on the
`
`procedure for removing information either unintentionally submitted or submitted in an incorrect
`
`application. A petition may be needed to remove all papers dated October 4, 1994 from this
`
`application.
`
`Claim Status
`
`31.
`
`The amending history for the claims is unclear, possibly based upon errors introduced
`
`when the application was reconstructed in 2002. What follows is a summary of the claims
`
`status found in the official file at this time:
`
`a.
`
`b.
`
`c.
`
`d.
`
`e.
`
`f.
`
`g.
`
`Claims 1-34 filed on 9/27/94
`
`Claims 1-53 filed on 10/4/94 (this amendment does not appear to amend
`
`9/27/94 claims, but rather contains a new set of claims)
`
`Claims 35-38 added on 1/20/95 (Claim 3 also canceled)
`
`Claims 39-65 added on 2/2/95
`
`Restriction mailed for Claims 1-65 on 8/1/95
`
`Election without traverse to Group I on 8/24/95
`
`Claims 18-37, 39-62, 65 withdrawn in first action on 11/17/95
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-12
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 11
`
`h.
`
`i.
`
`j.
`
`k.
`
`Claims 18-37, 39-62, 65 canceled and Claims 66-84 added on 5/20/96
`
`Claims 67,72, 82 are canceled in after-final amendment of 1/23/97
`
`Claims 1-2, 4-17, 38, 63-64, 66, 68-71, 73-81, 83-84 allowed on 2/20/97
`
`Claims 9, 64, 77-79 were amended on 4/29/09
`
`Claim Objections
`
`32.
`
`Claims 77-79 are objected to because of the following informalities: claims 77-79, based
`
`on the instant drawings, appear to have the location of the male engaging and female
`
`cooperating portions mixed up according to the conventional use of male and female when
`
`applied to connectors. The drawings (see at least fig. 6) show a female portion (88) on the
`
`second stent member and a male portion (78) on the first stent, since portion (78) is inserted
`
`into portion (88). The instant specification correctly identifies the location of the male and female
`
`portions on at least p. 4 II. 13-27 and p. 10, II. 23-27. However, on page 28, II. 7+ of the
`
`specification, these portions are reversed, similar to the claims. Appropriate correction is
`
`required.
`
`Claim Rejections - 35 USC § 112
`
`33.
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the
`art to which it pertains, or with which it is most nearly connected, to make and use the same and shall
`set forth the best mode contemplated by the inventor of carrying out his invention.
`
`34.
`
`The following is a quotation of the second paragraph of 35 U.S.C. 112:
`
`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.
`
`35.
`
`Claims 63-64 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with
`
`the written description requirement. The claim(s) contains subject matter which was not
`
`described in the specification in such a way as to reasonably convey to one skilled in the
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-13
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 12
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`relevant art that the inventor(s), at the time the application was filed, had possession of the
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`claimed invention
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`36.
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`Claim 63 claims "barbs disposed adjacent to said fabric to secure said prosthesis to
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`said blood vessel." On page 15 of the original specification, the barbs in the second stent are
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`described as being engaged with the artery when no fabric layer exists or as being covered by
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`the fabric graft, if used. When the fabric graft is over the barbs it aids in the prevention of the
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`introduction of emboli into the blood stream. Therefore, the barbs, when covered are not
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`described as securing the prosthesis, which is what Claim 63 requires.
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`37.
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`Claim 64 claims the barbs extend through the fabric, and the original disclosure fails to
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`provide support for this arrangement.
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`38.
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`Claims 5, 8, 12,63-64, 79-81,83-84 are rejected under 35 U.S.C. 112, second
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`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
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`matter which applicant regards as the invention.
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`39.
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`Claim 5 contains a parenthetical expression which is not given patentable weight.
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`Therefore, the claim lacks clarity.
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`40.
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`Claim 8, "the hoop" lacks antecedent basis. Claim 6 recites a plurality of hoops. In
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`addition, this claim may conflict with the description found on pp. 9-10. On p. 10, the
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`specification describes "the planes of the hoops are not skewed with respect to the longitudinal
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`axis of the stent; the longitudinal ends of the stent are 'square' to said longitudinal axis ... " While
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`the claim is describing the plane of the circumference of the hoop at the end of the stent as
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`being square.
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`41.
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`Claim 12 recites the limitation "to engage the endoluminal surface ... " however, this
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`phrase lacks antecedent basis because Claim 11 only positively recited the first stent portion
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`being "adapted to be disposed within a blood vessel" not that it had been disposed.
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`W.L. Gore & Associates, Inc.
`Exhibit 1013-14
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 13
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`42.
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`Claim 63 recites the limitation "barbs disposed adjacent to said fabric" but the claim
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`limitation is unclear as to which structure contains the barbs.
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`43.
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`Claim 79 recites the limitation "said female cooperating portion" in the last line of the
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`claim. There is insufficient antecedent basis for this limitation in the claim.
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`44.
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`45.
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`Claim 80 recites the limitation "said bifurcation point" which lacks antecedent basis.
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`Claim 80 recites the limitation "a graft layer disposed in juxtaposition with said stent" in
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`the last line of the claim. This limitation in the claim is indefinite because there are two stents
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`claimed and the layer's location lacks clarity and precision.
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`46.
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`Claims 81 and 83 recite the limitation "said graft layer comprises a first graft layer and a
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`second graft layer" which is a numerical mismatch for a single layer to then be further defined as
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`having two layers.
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`47.
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`Claim 83 recites the limitation "the distal extremity of said female engaging portion" but
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`only the intermediate stent portion was previously described in Claim 80 as "extending distally"
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`so this new limitation for a female engaging portion lacks antecedent basis.
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`48.
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`Claim 83 lacks antecedent basis for "said second distal stent portion" and for "said inner
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`sleeve".
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`49.
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`Claim 83 is indefinite because the limitation "substantially blood-tight seal" lacks clarity
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`and precision.
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`Claim Rejections - 35 USC § 102
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`50.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
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`basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless -
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`(e) the invention was described in (1) an application for patent, published under section 122(b), by
`another filed in the United States before the invention by the applicant for patent or (2) a patent
`granted on an application for patent by another filed in the United States before the invention by the
`applicant for patent, except that an international application filed under the treaty defined in section
`351 (a) shall have the effects for purposes of this subsection of an application filed in the United States
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-15
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 14
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`only if the international application designated the United States and was published under Article 21 (2)
`of such treaty in the English language.
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`(f) he did not himself invent the subject matter sought to be patented.
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`51.
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`Claims 1,2,4, 11, 12, 63, 80-81 and 83-84, as best understood, are rejected under 35
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`U.S.C. 102(e) as being anticipated by Martin (USP 5,575,817). In particular, Martin discloses a
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`bifurcated stent having an assembly bifurcation for use with an angiological bifurcation of a
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`blood vessel into two branched vessels comprising a first stent comprising a proximal stent
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`portion adapted to be disposed within the blood vessel, a first distal stent portion adapted to
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`extend across the angiological bifurcation into one of the branched vessels and an intermediate
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`stent portion extending distally relative to the assembly bifurcation and a second stent (2; fig. 1)
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`comprising a second distal stent portion joined to the intermediate stent portion of the first stent
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`and adapted to allow blood to flow from the proximal portion into the other branched vessel.
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`52.
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`53.
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`Regarding claims 2,4, 11, 63, 80-81, and 83-84, see figs. 1-4.
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`Regarding claim 11, the second stent has a male engaging portion adapted to engage
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`the female cooperating portion of the intermediate stent portion (col. 3 II. 29-34; "2" expands
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`within "1 ").
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`54.
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`Regarding claim 12, the proximal end of the first bifurcated stent can be considered the
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`entire portion of (1) proximal of where reference number (3) is drawn to the stent in fig. 1. In this
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`case, the proximal end is flared radially outwardly toward its extremity since it has a smaller
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`diameter near 3 as compared to its proximal end near reference number (9) in fig. 1. Figure 4
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`also shows this flaring.
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`55.
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`56.
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`Regarding claim 63, see barbs (13).
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`Regarding claim 81, the stent may be "entirely covered" by a graft (col. 311. 14-16) and
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`therefore the graft on the inner surface of the intermediate portion (5) which forms the female
`
`W.L. Gore & Associates, Inc.
`Exhibit 1013-16
`
`

`

`Application/Control Number: 08/312,881
`Art Unit: 3731
`
`Page 15
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`cooperating portion may be considered the first graft layer and the graft covering the external
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`surface of the second distal portion which forms the male engaging portion can be considered
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`the second graft layer.
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`57.
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`58.
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`Regarding claims 83 and 84, see fig. 1.
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`Claims 1, 2, 4,11,12,63,80-81 and 83-84 are rejected under 35 U.S.C. 102(f)
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`because the applicant did not invent the claimed subject matter. The rejection of claims 1, 2, 4,
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`11, 12, 63, 80-81 and 83-84 is based upon interference No.1 04, 192 to which applicant is a
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`party. The interference proceeding determined that Applicants did not invent the subject matter
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`sought to be patented.
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`Claim Rejections - 35 USC § 103
`
`59.
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`The following is a quotation of 35 U .S.C. 1 03(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
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`60.
`
`This application currently names joint inventors. In considering patentability of the
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`claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various
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`claims was commonly owned at the time any inventions covered therein were made absent any
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`evidence to the contrary. Applicant is advised of the obligati