DETAILED 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 07/08/2026 have been entered. Claims 1-20 remain pending in the application.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claim 1 recites “configured to slidably received a guidewire” in line 9 and “configured to slidably receive the guidewire” in lines 10-11, before positively reciting “a guidewire” in line 16. Examiner suggests rearranging the claim language to positively recite “a guidewire” first in the claim, followed by the configured to language referencing “the guidewire”.
In line 8 of claim 9, “proximal region the fenestrated” should be changed to “proximal region of the fenestrated”.
Appropriate correction is required.
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) 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenberg et al. (US 2019/0000607).
Regarding claim 1, Greenberg et al. discloses a deployment device (100, FIG 1) for an endovascular prosthesis (131) comprising: a distal tip (Distal tip of 112 shown in FIGs 10A-10D, [0068-0069]); a delivery catheter assembly, the delivery catheter assembly comprising: an outer sheath (106) configured to house a fenestrated endovascular prosthesis (106 surrounds prosthesis 131 in the region 107, [0050, 0072], FIG 12); an inner sheath (118) at least partially within the outer sheath (FIG 8, 10D) and coupled to the distal tip (FIG 10D and connected through mechanical connection of the assembled device); and an intermediate sheath (112) between the outer sheath and the inner sheath (FIG 8 and 10D), the intermediate sheath comprising a guide lumen (92, FIG 8, [0066]) configured to slidably receive the guidewire (146) between the fenestrated endovascular prosthesis and the outer sheath in a first portion of the delivery catheter assembly (See annotated FIG 10D showing the region of the guidewire being positioned between the prosthesis and the outer sheath 106), and between the fenestrated endovascular prosthesis and the inner sheath in a second portion of the delivery catheter assembly (See annotated FIG 5 below wherein the guidewire is positioned between the inner sheath ad at least some opposed wall of the prosthesis) that is distal to the first portion of the delivery catheter assembly (The location of the second portion is distal to the location of the second portion); a handle assembly (130 and 102, FIGs 1 and 2, [0050-0058]); and a guidewire (146) extending from a periphery of the distal tip (FIG 10D), through the guide lumen (FIG 8), and through the handle assembly (At the proximal end, FIG 11, out of 120, [0051-0053]).
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Regarding claim 2, Greenberg et al. discloses the distal tip comprises grooves (222, [0069], FIG 10A-10C) configured to provide a slidable path for the guidewire between the outer sheath and an exterior of the deployment device (Which passes through lumen 92 while housed within 122, FIG 10D).
Regarding claim 3, Greenberg et al. discloses the inner sheath (118) comprises a lumen (See lumen in FIG 8) configured to slidably receive a second guidewire (138).
Regarding claim 4, Greenberg et al. discloses the handle assembly comprises an opening (120) adjacent a luer fitting (116, FIG 11, [0051]), wherein the opening is configured to slidably receive the guidewire (146 passes through 120 housed within 122).
Regarding claim 5, Greenberg et al. discloses outer sheath defines an annular space between the distal tip and the intermediate sheath, wherein the annular space of the outer sheath is configured to receive the guidewire between the distal tip and the intermediate sheath (FIG 10D show 146 being received outside of intermediate sheath and inside of outer sheath 106 in a state where 106 is fully extended such as in FIG 1).
Regarding claim 6, Greenberg et al. discloses the guide lumen is adjacent an outer surface of the inner sheath (FIG 8).
Regarding claim 7, Greenberg et al. discloses the guide lumen comprises a blood flow restrictor member (121, FIG 9, [0051]).
Regarding claim 8, Greenberg et al. discloses the delivery catheter assembly is configured to house the fenestrated endovascular prosthesis between the outer sheath and the inner sheath (FIG 2, [0050]).
Regarding claim 9, Greenberg et al. discloses a system for deploying a fenestrated endovascular prosthesis (100) comprising: a fenestrated endovascular prosthesis (131, having fenestrations 147, [0059], FIGs 2-5), the fenestrated endovascular prosthesis comprising: a wall (graft wall of 131) defining a bore (Main body lumen, FIG 5-5A); and a fenestration (147) extending from the bore through the wall to an exterior of the fenestrated endovascular prosthesis ([0059]); a guidewire (138) extending through the fenestration (FIG 14 shows 138 passing from outside of the prostheses to inside of the prosthesis via fenestration 260, [0076-0077]), wherein the guidewire extends along an exterior of a proximal region of the fenestrated endovascular prosthesis ([0076] states that 250, where guidewire 138 is connected to the outside of the prosthesis is proximal of the fenestration 147. Therefore the guidewire extends along an exterior of the prosthesis along a proximal region as defined in [0076]) and extends through the fenestration (FIG 14) into the bore at a region distal to the proximal region of the fenestrated endovascular prosthesis (The region here 138 resides within the bore/lumen of the prosthesis is located distally. This definition of distal and proximal ends is consistent with what is set forth throughout the disclosure. [0013] discloses the establishment of distal and proximal directions); and a deployment device configured to slidably receive the guidewire (Remainder of device 100 apart from the prosthesis), the deployment device comprising: a delivery catheter assembly configured to receive the fenestrated endovascular prosthesis (FIG 1).
Regarding claim 10, Greenberg et al. discloses the delivery catheter comprises an outer sheath (106) configured to encircle the fenestrated endovascular prosthesis (106 surrounds prosthesis 131 in the region 107, [0050, 0072], FIG 12); and the guidewire extends along a groove in a distal tip of the deployment device into the bore of the fenestrated endovascular prosthesis in the outer sheath (FIG 5, 8. FIG 10A-10C show the groove in the distal tip of 112, through which the guidewire extends as shown in FIG 10D).
Regarding claim 11, Greenberg et al. discloses the delivery catheter assembly further comprises an intermediate sheath (118); an annular space between the intermediate sheath and the distal tip is configured to receive the fenestrated endovascular prosthesis (FIG 10D shows the end of 118 and the beginning of prosthesis 131, which is positioned between 118 and distal tip 110, FIG 3); the guidewire extends from the exterior of the fenestrated endovascular prosthesis in the outer sheath into the intermediate sheath (FIG 12).
Regarding claim 12, Greenberg et al. discloses intermediate sheath comprises a guide lumen (94) configured to slidably receive the guidewire (FIG 8, [0066-0071]).
Regarding claim 13, Greenberg et al. discloses the deployment device further comprises a handle assembly (130 and 102, FIGs 1 and 2, [0050-0058]); and the guidewire extends from the intermediate sheath into the handle assembly (FIG 1 shows 146 extending out of the handle assembly).
Regarding claim 14, Greenberg et al. discloses the guidewire extends out of the handle assembly through an opening in the handle assembly (access port 120, [0068, FIG 1).
Regarding claim 15, Greenberg et al. discloses the intermediate sheath comprises a blood flow restrictor member (117 and 121, FIG 9) configured to prevent blood flow through the intermediate sheath into the handle assembly ([0051]).
Regarding claim 16, Greenberg et al. discloses a prosthesis deployment device(100, FIG 1) comprising: a delivery catheter assembly comprising: an outer sheath (106); an intermediate sheath (112) disposed within the outer sheath (FIG 1 and 8), the intermediate sheath comprising a guide lumen (92) configured to receive a first guidewire (146, FIG 8, [0066, 0071]); and an inner sheath (118) disposed within the outer sheath (FIG 8), the inner sheath comprising a lumen (lumen of 118 shown in FIG 8) configured to receive a second guidewire (138) wherein the inner sheath and the outer sheath are axially aligned (FIG 10D shows that 118 and 106 extend parallel to the same longitudinal axis); a housing (114, FIG 4) operably coupled to the delivery catheter assembly ([0050]); and an actuator (108) operably coupled to the housing (FIG 1-3) such that displacement of the actuator displaces the outer sheath relative to the inner sheath to partially deploy the prosthesis (Proximal movement of 108 relative to 114 causes proximal retraction of 106, see relative positioning of 108 and 114 in FIG 1 vs FIG 3).
Regarding claim 17, Greenberg et al. discloses a distal tip coupled to the delivery catheter assembly opposite the housing (Distal tip of 112 shown in FIGs 10A-10D), the distal tip comprising a groove (222, [0069]) configured to receive the first guidewire (Which passes through lumen 92 while housed within 122) and an opening (Another of the scalloped openings 222) configured to receive the second guidewire (138, which passes through lumen 94 while housed within 118, FIG 10D).
Regarding claim 18, Greenberg et al. disclose the housing comprises a luer fitting configured to receive the second guidewire (116, FIG 11, [0068]), and wherein the housing comprises a first opening (120) outside the luer fitting configured to receive the first guidewire (FIG 11, [0068]).
Regarding claim 19, Greenberg et al. disclose the outer sheath is configured to receive the prosthesis such that the first guidewire extends through a wall of the prosthesis (As shown in FIG 4 and 5 where the guidewire extends out of fenestration 147).
Regarding claim 20, Greenberg et al. disclose the guide lumen comprises a blood flow restrictor member (121, FIG 9, [0051]).
Response to Arguments
Applicants’ arguments filed 07/08/2026 regarding claim 1 have been fully considered but they are not persuasive. Applicant argues on pages 9-10 regarding the pathway of the guidewire relative to fenestration 147 that “the guidewire(s) enter the interior of the graft 131 at a proximal opening an exits exterior to the stent graft at fenestration 147, and therefore cannot meet the limitations of the claim as amended. However, it is the examiner’s position that this interpretation is overly narrow. As set forth above, there exists at least a first and second portion along the length of the delivery catheter assembly wherein the limitations are satisfied. Examiner notes that the wording of the claim is broad regarding if the positioning of the guidewire is being radially or axially defined. Therefore, applicants argument is not persuasive and a rejection is set forth above with a new interpretation to address the addition of “that is distal to the first portion of the delivery catheter assembly”.
Applicants’ arguments regarding claim 9 have been considered and are persuasive. However, claim 9 is now rejected in view of an alternative interpretation of Greenberg in order to recite the newly added limitations.
Applicants’ arguments regarding claim 16 have been fully considered but they are not persuasive. Regarding claim 16, applicant argues that the inner and outer sheath of Greenberg (118 and 106) fail to meet the newly recited limitations of being axially aligned. It is the examiners position that the limitation “axially aligned” does not necessarily require coaxial alignment as suggested in the arguments. Because 118 is nested within and extends along 106, the two sheaths are interpreted as being axially aligned as the extend in the same axial direction.
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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