DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendments filed on 02/20/2026 have been entered. Claims 15-22, 24-35 remain pending in the application.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 02/20/2026, with respect to the rejection(s) of claim(s) 15 under 35 USC 102(b) in view of Chobotov and in view of Fawzi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of the teachings of Majercak et al. (US 2008/0039926).
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, 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 negated by the manner in which the invention was made.
Claim(s) 15, 24-27, 29, 30, and 32-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Fawzi et al. (US 2009/0299462) in view of Majercak et al. (US 2008/0039926).
Regarding claim 15, Fawzi discloses a branched endoprosthesis (FIG 4 and 9, [0063]) comprising: a body (24) having a first leg (32) and a second leg (46) extending longitudinally therefrom (FIG 9), the first leg comprising a first stent (78, FIG 4, [0046 and 0054-0055]) and a first graft component (Graft material forming 32, [0046] discloses that stent 78 can extend along an exterior of the graft), the second leg comprising a second stent (80) and a second graft components (Graft material forming 46), the body being deliverable to a position within a vessel while in a delivery configuration (Although the delivery system is not shown, it is understood that the endoprosthesis is delivered to the deployment site in a collapsed configuration. [0041] discloses the body as being collapsible. [0039] discloses a main delivery catheter for delivery of the entire system) and being at least partially deployable between the delivery configuration and a deployed configuration (FIG 9 shows a partially deployed configuration and FIG 10 shows a fully deployed configuration, [0068]); and a restraint (122) releasably coupling the first and second legs ([0068]), the restraint configured to minimize relative movement between the first and second legs (By constraining the legs together, [0068]) to facilitate cannulation of the first leg or the second leg (by holding the legs together until proper positioning has been achieved, the restraint facilitates cannulation of the leg by ensuring ideal positioning).
Fawzi is silent regarding the restraint routing around the first stent between the first stent and the first graft component and routing around the second stent between the second stent and the second graft component.
However, Majercak et al. teaches in the same field of endeavor of stent grafts (110, FIG 2) that a first stent portion (120) can be tethered to a second stent portion (112) using a restraint (130, FIG 3, 6, 7, [0039]) which is routed around the first stent between the first stent (Specifically apices 134, [0039]) and the graft material (wherein 118 is the graft material, [0038]) and the stent frame 122 is circumferentially external to the graft material. Tether 130 is routed between the stent and the graft, see FIGs 6-7) for slidably connecting the two elements.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the restraint of Fawzi to releasably couple the first and second legs by routing around the first stent between the first stent and the first graft component and routing around the second stent between the second stent and the second graft component, as taught by Majercak, instead of routing through the suture loops as taught by Fawzi, for the purpose of using a technique commonly known in the art for achieving the predictable result of using a tether to restrain a first stent graft member to a second stent graft member.
Regarding claim 24, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses the first leg is substantially axially longer than the second leg (FIG 9-12 show leg 32 extending into the ipsilateral artery 200 is substantially longer than leg 46 extending into the contralateral artery 204).
Regarding claim 25, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses the first leg and the second leg are structurally biased to angle apart in a Y configuration (FIG 10; the legs assume this position when wire 122 is released, therefore they are understood to be biased to this configuration).
Regarding claim 26, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses a plurality of serially aligned support components (100, FIG 4, and guidewire 48, [0042] are interpreted as support components. 48 and 100 are understood to be “serially aligned” because they are positioned at respective longitudinal positions along the device) adapted to hold one of the legs open for the cannulation (sleeve 100 is fixed within each leg and therefore is at least adapted to hold the legs open when a guidewire is placed therein).
Regarding claim 27, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses a radiopaque marker at a distal end of at least one of the legs (116, FIG 4, [0078]).
Regarding claim 29, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses at least one of the body, the first leg, or the second leg remains undeployed when the body is between the delivery configuration and the deployed configuration (Since the distal end of the main body is deployed first, and the first leg is longer than the second leg, there is at least some state during deployment in which the first leg remain partially undeployed while the remainder of the body deploys).
Regarding claim 30, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses the restraint is a tether (Release wire 122 is interpreted as a tether) that is releasable to deploy the body to a fully deployed configuration (Upon full retraction of 122, the body can be fully deployed as in FIG 10).
Regarding claim 32, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 30. The device as modified further discloses the first and second stents having one or more apices (apices are understood to be a feature of stents, as shown in FIG 4 of Fawzi and FIG 3 and 6 of Majercak), wherein a portion of the tether is secured to the one or more apices of the first and second stents (in the device as modified and as taught by Majercak, the tether is secured to the apices).
Regarding claim 33, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 30. The device as modified further discloses the first and second stents having one or more apices (apices are understood to be a feature of stents, as shown in FIG 4 of Fawzi and FIG 3 and 6 of Majercak), wherein a portion of the tether is routed between one of the one or more apices of the first and second stents and a wall of the first and second graft components (because the stents and their apices are positioned on the radial outer surface of the graft wall, and the tether is routed around the apices, they are further routed between the apices and the wall of the graft material).
Regarding claim 34, Fawzi/Majercak discloses the invention substantially as claimed, as set forth above for claim 30. The device as modified further discloses the first graft component comprising a first graft wall associated with the first leg (The tubular graft material of the first leg 32), the second graft component comprising a second graft wall associated with the second leg (The tubular graft material of the second leg 46), the first stent comprising a first set of apices associated with the first leg (The stent forming 78 is understood to have multiple apices), and the second stent comprising a second set of apices associated with the second leg (The stent forming 80 is understood to have multiple apices), wherein a first portion of the tether is routed between the first graft wall and at least one of the first set of apices, and a second portion of the tether is routed between the second graft wall and at least one of the second set of apices (because the stents and their apices are positioned on the radial outer surface of the graft wall, and the tether is routed around the apices, they are further routed between the apices and the wall of the graft material on each of the first and second legs).
Claims 16, 17, 20-22, and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fawzi et al. (US 2009/0299462) in view of Majercak et al. (US 2008/0039926), further in view of Richard (US 5,755,769).
Regarding claim 16-17 and 20-22, Fawzi et al./Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi et al. further discloses deployment of the body ([0068-0077]).
Fawzi is silent regarding a sheath surrounding the body and releasably restraining the body toward the delivery configuration, wherein the sheath is a longitudinally extending structure with a lumen extending therethrough, the sheath has opposite sides that are releasably held together by an elongate member to restrain the body in the delivery configuration, wherein the sheath has a plurality of holes through which the elongated member extends to releasably hold together the opposite sides of the sheath, and wherein the sheath is partially removable from a distal portion of the body to deploy the body to the deployed configuration.
However, Richard teaches a mechanism for controlled deployment of an expandable stent graft (1A) comprising a sheath (4, specifically the embodiment of FIG 8) surrounding the body (FIG 8 shows body 1A surrounded by sheath 4) and releasably restraining the body toward the delivery configuration (4 is used to releasable constrain 1A in the low profile delivery configuration), wherein the sheath is a longitudinally extending structure with a lumen extending therethrough (FIG 8 shows the lumen of tubular structure 4, through which 1A passes), the sheath has opposite sides (See left and right sides of the seam where interlocking gussets 20 connect) that are releasably held together by an elongate member (21) to restrain the body in the delivery configuration (col 3 line 61-col 4 line 5), wherein the sheath has a plurality of holes through which the elongated member extends to releasably hold together the opposite sides of the sheath (Each gusset 20 has a channel through which 21 passes, FIG 8), and wherein the sheath is partially removable from a distal portion of the body to deploy the body to the deployed configuration (As shown in FIG 8, when elongated member 21 is partially retracted, the sheath is removed form a distal portion of the body thereby allowing it to expand to the deployed configuration).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Fawzi to comprise the sheath and elongate member deployment mechanism taught by Richard, for the purpose of substituting a commonly known means for controlling the release of the endoprosthesis body with the added benefit of allowing the sheath to release form the body in a gradual manner to ensure precises placement of the body within the target vasculature.
Regarding claim 31, Fawzi et al./Majercak discloses the invention substantially as claimed, as set forth above for claim 30.
Fawzi is silent regarding achieving the controlled deployment by means of a sheath surrounding the body and releasably restraining the body toward the delivery configuration, wherein a portion of the tether is tucked under one or more undeployed portions of the sheath.
However, Richard teaches a mechanism for controlled deployment of an expandable stent graft (1A) comprising a sheath (4, specifically the embodiment of FIG 8) surrounding the body (FIG 8 shows body 1A surrounded by sheath 4) and releasably restraining the body toward the delivery configuration (4 is used to releasable constrain 1A in the low profile delivery configuration, col 3 line 61-col 4 line 5), wherein the sheath has opposite sides (See left and right sides of the seam where interlocking gussets 20 connect) that are releasably held together by an elongate member (21) to restrain the body in the delivery configuration (col 3 line 61-col 4 line 5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Fawzi to comprise the sheath and elongate member deployment mechanism taught by Richard, for the purpose of substituting a commonly known means for controlling the release of the endoprosthesis body with the added benefit of allowing the sheath to release form the body in a gradual manner to ensure precises placement of the body within the target vasculature. In the device as modified, a portion of the tether is tucked under one or more undeployed portions of the sheath because the tether is fed through the first and second legs, which are surrounded by the sheath.
Claims 18-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fawzi et al. (US 2009/0299462) in view of Majercak et al. (US 2008/0039926), further in view of Richard (US 5,755,769), further in view of Norris (US 2012/0296360).
Regarding claim 18, Fawzi et al./Majercak/Richard discloses the invention substantially as claimed, as set forth above for claim 16.
The device as modified is silent regarding a material of the sheath, particularly the sheath comprising one or more of: nylon, polycarbonate, polyethylene, polypropylene, polytetrafluoroethylene, polyvinyl chloride, polyurethane, or polysiloxane.
However, Norris teaches in the same field of endeavor a sheath (106) surrounding an endoprosthesis body (106 (FIGs 2a-2c) for selectively controlling the release/deployment of the body ([0021-0023]) wherein the sheath comprises PTFE ([0021] discloses Leopold US 6,352,561 is incorporated by reference, which teaches a material of the sleeve can be PTFE, col 7 lines 22-35).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to select PTFE as a material for the sheath, as taught by Norris, for the purpose of selecting a biocompatible material commonly used in the art which has the additional benefit of being creep resistant and able to withstand loads without stretching over time.
Regarding claim 19, Fawzi et al./Majercak discloses the invention substantially as claimed, as set forth above for claim 16.
The device as modified is silent regarding a material of the sheath, particularly the sheath comprising stainless steel.
However, Norris teaches in the same field of endeavor a sheath (106) surrounding an endoprosthesis body (106 (FIGs 2a-2c) for selectively controlling the release/deployment of the body ([0021-0023]) wherein the sheath can comprise materials similar to those used to form a graft ([0029]) and further discloses materials used to form a graft can include stainless steel ([0036]) among other medical grade materials such as PTFE.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to select stainless steel as a material for the sheath for the purpose of selecting a medical grade material commonly known in the art for forming various components of endoprosthesis devices.
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Fawzi et al. (US 2009/0299462) in view of Majercak et al. (US 2008/0039926), further in view of Ouriel (US 2003/0120333).
Regarding claim 28, Fawzi et al./Majercak discloses the invention substantially as claimed, as set forth above for claim 15. Fawzi further discloses an expanded diameter of 13 mm ([0055]) but fails to teach a delivery profile o of less that 18Fr.
However, Ouriel teaches a bifurcated endoprosthesis (10, FIG 1) deliverable in a sheath (302, FIG 15) having a profiled of 12 to 18 French ([0127]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to select a profile size of less than 18 French, as taught by Ouriel, since Ouriel teaches that this size is appropriate for delivery of an endoprosthesis.
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.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771