DETIALED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed on 05/13/2026 have been entered. Claims 1-20 remain pending in the application.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive. Applicant argues on pages 6-8 that Saeed fails to particularly disclose “advancing a sheath over the pre-cannulation wire”. Examiner acknowledges applicants’ discussion regarding different movements of the escort catheter 40 and generally agrees with the characterization of the disclosure that is described. However, it is the examiners position that, as it pertains to the relative movement of the sheath (interpreted as escort catheter 40) and the precannulation wire (interpreted as 36/59), [0109] of Saeed states “the device 10 is employed in the same fashion as the mode of the device 10 which translates the escort catheter 40 along the second guide wire”. Although not given a reference number, [0090] discloses that wire 36 is the second guide wire. Therefore, [0109] states that an operation of the device can be employed in the same manner as the mode which translates 40 along 36. This operation is described in more detail in [0090] where it is stated that “the escort catheter 40 is now translated along the pre-positioned second guide wire 36”. This step is used to move third guidewire 54, which is temporarily connected to 40, through cuff 22. Although other embodiments are taught in which 40 is constrained to 59, it is believed that there is sufficient disclosure of an alternative operation in which 40 is translated along 36, therefore meeting the limitation of “advancing a sheath over the pre-cannulation wire).
For the same reasons, the arguments regarding claim 14 are also not found to be persuasive.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saeed (US 2008/0255656).
Regarding claim 1, Saeed discloses a method of treatment (Abstract, [0026]) comprising: positioning a primary endoprosthesis (12, [0079], FIG 1, 7-13, and 16-18) at a desired deployment location in a target blood vessel (Aorta 16, [0079], FIG 4-10) using a deployment catheter (38, FIG 16 and 18), the primary endoprosthesis including a pre-cannulation wire (36/59, [0104-0113]) anchored to an anchor strand associated with the deployment catheter (where 35 is the anchor strand associated with 38, FIG 18, and 59 is anchored to 35 via loop 61, FIG 16, [0105]), the pre-cannulation wire extending along the deployment catheter (As shown in FIG 16 and 18) and through a fenestration and/or a branch of the primary endoprosthesis (36 extends into the fenestration of branch 22/24, [0083, 0087], FIG 16 and 18); advancing a sheath (40) over the pre-cannulation wire ([0109] “the device 10 is employed in the same fashion as the mode of the device 10 which translates the escort catheter 40 along the second guide wire” and [0090] “the escort catheter 40 is now translated along the pre-positioned second guide wire 36”); extending a guidewire (54) from the sheath through the fenestration and/or branch (54 is snared by 46 of 36 and pulled through the fenestration as shown in FIG 18, [0108 and 0110]); delivering a secondary endoprosthesis (28) over the guidewire through the fenestration and/or branch ([0097]); and releasing the pre-cannulation wire from the anchor strand ([0091] discloses “the snare 46 may be released and the second guide wire 36 and the escort catheter 40 removed”. It is understood that this step removed the pre-cannulation wire from the anchor strand in order to achieve removal from the branch 22).
Regarding claim 2, Saeed discloses releasing the pre-cannulation wire from the anchor strand includes sliding the anchor strand from a loop at a leading end of the pre-cannulation wire (FIGs 16, 19, 20 show the loop 61 is sized to be slidably received over anchor strand 35 and therefore withdrawal of 36/59 includes sliding the loop off the distal end of 35).
Regarding claim 3, Saeed discloses releasing a plurality of pre-cannulation wires from the anchor strand (In the embodiments of FIG 14-15b, [0099-0103], where snare 46 is separate from 36, the wire of 46 forms at least a second pre-cannulation wire which is released from the anchor strand, upon release of loop 61 from anchor strand 35).
Regarding claim 4, Saeed discloses the pre-cannulation wire is anchored to the deployment catheter at a location distal to the primary endoprosthesis (FIG 16 and 18 show the anchoring point is distal to 12).
Regarding claim 5, Saeed discloses the primary endoprosthesis positioned at the desired deployment location is an aortic arch endograft (Examiner notes the claim is directed towards the structure of the endograft, not specifying a step of positioning the endograft at the aortic arch. Although disclosed as being positioned at the bifurcation of the aorta at the second iliac artery, it is understood that the endograft being used is equally as capable of being used at an aortic arch and therefore is interpreted as meeting the limitations of being an aortic arch endoprosthesis).
Regarding claim 6, Saeed discloses the secondary endoprosthesis delivered over the guidewire through the fenestration and/or branch is a bridging stent (Second leg 28 is interpreted as a bridging stent because is spans the gap from the main body prosthesis to the second iliac artery).
Regarding claim 7, Saeed discloses retracting the pre-cannulation wire from the fenestration and/or branch ([0091] discloses “the snare 46 may be released and the second guide wire 36 and the escort catheter 40 removed”. It is understood that this step removed the pre-cannulation wire from the branch 22).
Regarding claim 14, Saeed discloses a method of treatment (Abstract, [0026]) comprising: positioning a primary endoprosthesis (12, [0079], FIG 1, 7-13, and 16-18) in a blood vessel (Aorta 16, [0079], FIG 4-10), where a pre-cannulation wire (36/59, [0104-0113]) is anchored to an anchor strand (where 35 is the anchor strand associated with 38, FIG 18, and 59 is anchored to 35 via loop 61, FIG 16, [0105]), the pre-cannulation wire extending along a deployment catheter (38, FIG 16 and 18) on which the primary endoprosthesis is mounted (As shown in FIG 16 and 18) and through a fenestration or branch of the primary endoprosthesis (36 extends into the fenestration of branch 22/24, [0083, 0087], FIG 16 and 18); advancing a sheath (40) over the pre-cannulation wire ([0109] “the device 10 is employed in the same fashion as the mode of the device 10 which translates the escort catheter 40 along the second guide wire” and [0090] “the escort catheter 40 is now translated along the pre-positioned second guide wire 36”); extending a guidewire (54) from the sheath through the fenestration or branch (54 is snared by 46 of 36 and pulled through the fenestration as shown in FIG 18, [0108 and 0110]); delivering a secondary endoprosthesis (28) over the guidewire through the fenestration or branch ([0097]); and releasing the pre-cannulation wire from the anchor strand ([0091] discloses “the snare 46 may be released and the second guide wire 36 and the escort catheter 40 removed”. It is understood that this step removed the pre-cannulation wire from the anchor strand in order to achieve removal from the branch 22).
Regarding claim 15, Saeed discloses releasing the pre-cannulation wire from the anchor strand includes sliding the anchor strand from a loop at a leading end of the pre-cannulation wire (FIGs 16, 19, 20 show the loop 61 is sized to be slidably received over anchor strand 35 and therefore withdrawal of 36/59 includes sliding the loop off the distal end of 35).
Regarding claim 16, Saeed discloses the pre-cannulation wire is anchored to the deployment catheter at a location distal to the primary endoprosthesis (FIG 16 and 18 show the anchoring point is distal to 12).
Regarding claim 17, Saeed discloses the primary endoprosthesis positioned at the desired deployment location is an aortic arch endograft (Examiner notes the claim is directed towards the structure of the endograft, not specifying a step of positioning the endograft at the aortic arch. Although disclosed as being positioned at the bifurcation of the aorta at the second iliac artery, it is understood that the endograft being used is equally as capable of being used at an aortic arch and therefore is interpreted as meeting the limitations of being an aortic arch endoprosthesis).
Regarding claim 18, Saeed discloses the secondary endoprosthesis delivered over the guidewire through the fenestration and/or branch is a bridging stent (Second leg 28 is interpreted as a bridging stent because is spans the gap from the main body prosthesis to the second iliac artery).
Regarding claim 19, Saeed discloses retracting the pre-cannulation wire from the fenestration or branch ([0091] discloses “the snare 46 may be released and the second guide wire 36 and the escort catheter 40 removed”. It is understood that this step removed the pre-cannulation wire from the branch 22).
Regarding claim 20, Saeed discloses advancing a sheath over the pre-cannulation wire comprises moving the sheath over the pre-cannulation wire such that the pre- cannulation wire slides through the sheath ([0109] “the device 10 is employed in the same fashion as the mode of the device 10 which translates the escort catheter 40 along the second guide wire” and [0090] “the escort catheter 40 is now translated along the pre-positioned second guide wire 36”. As described above, this is understood to comprise translation/sliding of the wire through the sheath).
Allowable Subject Matter
Claims 8-13 are allowed.
The following is an examiner’s statement of reasons for allowance: Regarding claim 8, the prior art of record fails to teach or render obvious a method comprising a plurality of pre-cannulation wires extending along a deployment catheter and anchored to an anchor strand; advancing one or more sheaths over a corresponding one of the plurality of canulation wires; and extending one or more guidewires from the one or more sheaths. Specifically, the prior art fails to discloses separate pre-cannulated wires placed though a corresponding fenestration and anchored to an anchor strand, in combination with a sheath having an additional guidewire. Saeed (US 2008/0255656) discloses a single pre-cannulation wire anchored to an anchor strand and the guidewire extending from a sheath as claimed, but fails to teach or render obvious the use of a plurality of pre-cannulation wires each extending through a corresponding fenestration. Roeder et al. (US 2013/0123907) teaches in FIG 11 a pre-cannulation wire (31) received in two separate fenestration (27A, 27B, FIG 8) and teaches advancing two sheaths (54A,B and 96A, B) and delivering two guidewires (94A, 94B). However, the pre-cannulation wire is formed as a single wire which loops at the distal end, and therefore fails to teach a plurality of pre-canulation wires anchored to an anchor strand.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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