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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/17/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 3/17/26. The claims 1-27 are pending. The claims 1, 6, 10, 20, 25, and 26 are amended.
Response to Arguments
Applicant’s arguments, filed 3/17/26 with respect to the rejections of claims 20-23, and 27 under 102(a)(1) as being anticipated by Rothstein (US2016/0235525), the rejections of claims 1, 3-6, 9, 10, 12-17, 25, and 26 under 103 as being unpatentable over Rothstein (US2016/0235525) in view of Tang (US2014/0316513) have been fully considered and the amendments overcome the previous rejections. However, under a new interpretation of the prior art, the claimed frame is interpreted as the arms 620 that extend around the stent 610.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 has the improper status identifier “(Currently Amended)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 20-23 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rothstein (US2016/0235525).
Regarding claim 20, Rothstein discloses a landing zone prosthesis comprising:
a frame (610);
an engineered landing zone (640); and
graft material (608) coupled at a first end to the frame and at a second end to the engineered landing zone (see Fig. 1, [0059]), wherein the graft material includes a non-stented portion between the frame and the engineered landing zone (skirt 608 is non-stented, [0056]);
wherein in a first configuration the frame (610) and the engineered landing zone (640) are radially compressed with the engineered landing zone longitudinally spaced from the frame (see Fig. 15),
wherein in a second configuration the frame (610) is radially expanded (see Fig. 19), the engineered landing zone is radially compressed (see Fig. 19), and the engineered landing zone longitudinally spaced from the frame (see Fig. 19), and
wherein in a third configuration the frame (610) is radially expanded (where the third configuration is interpreted as the configuration when the frame component 610 is radially expanded and the landing zone 640 is partially expanded so that a gap exists between the components), the engineered landing zone (640) is at least partially disposed within the frame and radially expanded (the component 640 is partially expanded within the frame 610 before being fully expanded as shown in Fig. 22), and the frame is secured to a vessel (frame 610 is already secured to vessel prior to expansion of component 640, see Fig. 21), wherein in the third configuration a radial gap is disposed between the engineered landing zone and the frame along at least a portion of the engineering landing zone disposed within the frame (radial gap is the radial distance between the frame 610 and the component 640 during partial expansion of 640).
Regarding claim 21, Rothstein discloses the landing zone prosthesis of claim 20, comprising endoanchors (barbs, [0059]), wherein in the third configuration, the frame (610) is secured to the vessel via the endoanchors disposed through the frame and into the vessel (barbs on the outer surface of 642, [0059]; where the barbs are delivered simultaneously with 642 of 640 into 612 of frame 610).
Regarding claim 22, Rothstein discloses the landing zone prosthesis of claim 21, wherein in a fourth configuration the frame (610) is radially expanded, the engineering landing zone (640) is disposed within the frame (see Fig. 21), and the engineering landing zone is radially compressed (the fourth configuration is interpreted as the configuration when the landing zone 640 is translated through the frame 610, see Fig. 21).
Regarding claim 23, Rothstein discloses landing zone prosthesis of claim 21, wherein the engineering landing zone (640) comprises at least one stent (frame 642, [0058]) and landing zone graft material (material attached to frame 642 illustrated in Fig. 14) coupled to the at least one stent (see Fig. 14).
Regarding claim 27, Rothstein discloses the landing zone prosthesis of claim 20, wherein in the third configuration the frame is substantially reverse funnel-shaped (the frame 610 has a funnel shape by conforming to the shape of the vessel and would therefore have a funnel shape), the engineered landing zone is substantially cylindrical (the component 640 is substantially cylindrical by having a longer length and extending down the vessel wall, see Fig. 23), and the radial gap is formed between the substantially cylindrical engineered landing zone and the reverse funnel-shaped frame (during partial expansion of 640, the gap would be formed between the cylindrical landing zone and funnel shaped frame).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-6, 9, 10, 12-17, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US2016/0235525) in view of Tang (US2014/0316513).
Regarding claim 1, Rothstein discloses a method for creating an engineered landing zone comprising:
delivering a landing zone prosthesis (600) in a radially compressed configuration to a site within a vessel ([0061]), the landing zone prosthesis including a frame (arm component 620 having arms 622, 624, 626, [0055]), an engineered landing zone (640), and graft material (608) coupled at a first end to the frame and at a second end to the engineered landing zone (see Fig. 14, [0059]), wherein the graft material includes a non-stented portion between the frame and the engineered landing zone (608 is non-stented, [0056]);
radially expanding the frame (620) at the site (see Fig. 19), wherein with the frame radially expanded, the engineered landing zone (640) remains in the radially compressed configuration longitudinally spaced from the frame (see Fig. 19);
securing the frame to the vessel ([0059]);
longitudinally translating the engineered landing zone (640) such that the engineered landing zone is at least partially disposed within the frame (see Figs. 21 and 22, [0059]); and
radially expanding the engineered landing zone (when the landing zone 640 is partially expanded before being fully expanded as shown in Fig. 22) at least partially within the frame,
wherein with the engineered landing zone fully radially expanded within the frame a radial gap is formed between the engineered landing zone and the frame along at least a portion of the engineering landing zone disposed within the frame (the radial gap is made by the body of stent 610 being between the loop of the arms 622, 624, 626 and the landing zone 640 when expanded, see Fig. 22, [0055]).
Rothstein is silent regarding delivering the prosthesis to a site of an aneurysm within a vessel.
Tang teaches that a transcatheter heart valve 200 and stent graft 300 assembly that is can be used for bypassing an aneurysm ([0085]). Therefore, it would have been obvious to one having ordinary skill in the art to have Rothstein be used for bypassing an aneurysm and expand Rothstein’s device at the site of the aneurysm in order to effectively treat an aneurysm as taught by Tang ([0085]).
Regarding claim 3, Rothstein/Tang makes obvious the method of claim 1, wherein securing the frame to the vessel comprises:
delivering endoanchors to within the frame (barbs on the outer surface of frame 642, [0059]; where the barbs are delivered simultaneously with the frame 642 of 640 and into frame 620); and
deploying the endoanchors through the frame and into the vessel to secure the frame to the vessel ([0059]).
Regarding claim 4, Rothstein/Tang makes obvious the method of claim 3, Rothstein further discloses wherein the graft material (608) lines at least a portion of the frame (See Fig. 23), wherein deploying the endoanchors further comprises deploying the endoanchors through the graft material ([0059]).
Regarding claim 5, Rothstein/Tang makes obvious the method of claim 1, Rothstein further discloses wherein the engineered landing zone (640) comprises at least one stent (frame of valve 642) and landing zone graft material coupled to the at least one stent (see Fig. 14), wherein radially expanding the engineered landing zone comprises radially expanding the at least one stent ([0069], Fig. 22).
Regarding claim 6, Rothstein/Tang makes obvious the method of claim 5, Rothstein further discloses wherein the at least one stent is self-expanding, and wherein the step of radially expanding the at least one stent comprises releasing the stent from a constraint to allow the at least one stent to self-expand ([0069]).
Regarding claim 9, Rothstein/Tang makes obvious the method of claim 5, Rothstein further discloses wherein the frame is self-expanding, and wherein radially expanding the frame comprises releasing the frame from a constraint to allow the frame to self-expand ([0054]-[0055]; Figs. 21-22).
Regarding claim 25, Rothstein/Tang makes obvious the method of claim 1, wherein with the frame radially expanded the frame is substantially reverse funnel-shaped (the arms 620 has a funnel shape by conforming to the shape of the vessel and would therefore have a funnel shape), wherein with the engineered landing zone fully radially expanded the engineered landing zone is substantially cylindrical (the component 640 is substantially cylindrical by having a longer length and extending down the vessel wall, see Fig. 23), and wherein the radial gap is formed between the substantially cylindrical engineered landing zone and the reverse funnel-shaped frame (the radial gap is made by the body of stent 610 being between the loop of the arms 622, 624, 626 and the landing zone 640 when expanded, see Fig. 22, [0055]).
Regarding claim 10, Rothstein discloses a method (Abstract) comprising:
delivering a landing zone prosthesis (600) in a radially compressed configuration ([0061]) to a site within a vessel ([0061]), the landing zone prosthesis including a frame (arm component 620 having arms 622, 624, 626, [0055]), an engineered landing zone (640), and graft material (608) coupled at a first end to the frame and at a second end to the engineered landing zone (see Fig. 14, [0059]), wherein the graft material includes a non-stented portion (608 is non-stented, [0056]) between the frame and the engineered landing zone (see Fig. 1);
radially expanding the frame (610) at the site (see Fig. 19), wherein with the frame radially expanded, the engineered landing zone (640) remains in a radially compressed configuration and spaced from the frame (Fig. 19);
securing the frame to the vessel ([0068]);
longitudinally translating the engineered landing zone (640) such that the engineered landing zone is at least partially disposed within the frame (see Fig. 21);
radially expanding the engineered landing zone (when the landing zone 640 is partially expanded) at least partially within the frame (the component 640 is partially expanded within the frame 620 before being fully expanded as shown in Fig. 22), wherein upon full radial expansion of the engineered landing zone a radial gap is formed between the engineered landing zone and the frame along at least a portion of the engineering landing zone disposed within the frame (the radial gap is made by the body of stent 610 being between the loop of the arms 622, 624, 626 and the landing zone 640 when expanded, see Fig. 22, [0055]).
Rothstein is silent regarding the method being for bypassing an aneurysm, delivering the landing zone prosthesis to an aneurysm, delivering an endovascular prosthesis to the site such that a portion of the endovascular prosthesis is disposed within the engineered landing zone; and radially expanding the endovascular prosthesis such that the portion of the endovascular prosthesis disposed within the engineered landing zone engages the engineered landing zone.
Tang teaches that a transcatheter heart valve 200 and stent graft 300 assembly that is can be used for bypassing an aneurysm ([0085]). Therefore, it would have been obvious to one having ordinary skill in the art to have Rothstein be used for bypassing an aneurysm and deliver Rothstein’s landing zone to the aneurysm in order to effectively treat an aneurysm as taught by Tang ([0085]).
Tang further teaches delivering an endovascular prosthesis (400) to the site such that a portion of the endovascular prosthesis is disposed within the stent graft assembly (see Fig. 3), and radially expanding the endovascular prosthesis (400) such that the portion of the endovascular prosthesis disposed within the stent graft assembly engages the stent graft assembly. Therefore, It would have been obvious to one having ordinary skill in the art to have delivered an endovascular prosthesis to the site such that a portion of the endovascular prosthesis is disposed within the engineered landing zone; and radially expanding the endovascular prosthesis such that the portion of the endovascular prosthesis disposed within the engineered landing zone engages the engineered landing zone as taught by Tang. Doing so would facilitate anchoring of the device from the aortic root to the hemiarch (see [0034], [0043]).
Regarding claim 12, Rothstein/Tang makes obvious the method of claim 10, Rothstein further discloses wherein securing the frame to the vessel comprises:
delivering endoanchors to within the frame (barbs on the outer surface of 642, [0059]; where the barbs are delivered simultaneously with the frame 642 of 640 into the frame 620); and
deploying the endoanchors through the frame and into the vessel to secure the frame to the vessel ([0059]).
Regarding claim 13, Rothstein/Tang makes obvious the method of claim 12, Rothstein further discloses wherein the graft material (608) lines at least a portion of the frame (see Fig. 23), wherein deploying the endoanchors further comprises deploying the endoanchors through the graft material ([0059]).
Regarding claim 14, Rothstein/Tang makes obvious the method of claim 12, Rothstein further discloses wherein the engineered landing zone (640) comprises at least one stent (frame of 642) and landing zone graft material coupled to the at least one stent (see Fig. 14), wherein radially expanding the engineered landing zone comprises radially expanding the at least one stent ([0069]).
Regarding claim 15, Rothstein/Tang makes obvious the method of claim 14, Rothstein further discloses wherein the at least one stent is self-expanding, and wherein the step of radially expanding the at least one stent comprises releasing the stent from a constraint to allow the at least one stent to self-expand ([0061], [0069], Fig. 22).
Regarding claim 16, Rothstein/Tang makes obvious the method of claim 14, Rothstein further discloses wherein the frame is self-expanding, wherein radially expanding the frame comprises releasing the frame from a constraint to allow the frame to self-expand ([0054]-[0055], Fig. 21-22).
Regarding claim 17, Rothstein/Tang makes obvious the method of claim 10; yet, is silent regarding wherein the engineered landing zone further includes a mobile external coupling, wherein radially expanding the engineered landing zone comprises radially expanding the mobile external coupling, further comprising:
delivering a branch stent graft to the site such that a portion of the branch stent graft is disposed within the mobile external coupling and a portion of the branch stent graft is disposed within a branch vessel branching from the main vessel; and radially expanding the branch stent graft such that the portion of the branch stent graft disposed within the mobile external coupling engages the mobile external coupling. Tang teaches a stent valve 200 (engineered landing zone) having orifices 202 (mobile external coupling) in the engineered landing zone (stent valve 200). Where the orifices are radially expanded with the stent valve 200 expansion. The orifices allow stent grafts 700 (branch stent graft) to be delivered within the orifice and deployed into the coronary ostia ([0060]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have included a mobile external coupling that is radially expanded, and delivering a branch stent graft within the mobile external coupling, and radially expanding the branch stent graft within the mobile external coupling as taught by Tang in order to provide ongoing blood flow to the native coronary arteries ([0060]).
Regarding claim 26, Rothstein/Tang makes obvious the method of claim 10; yet, is silent regarding wherein with the frame radially expanded the frame is substantially reverse funnel-shaped (the frame 620 has a funnel shape by conforming to the shape of the vessel and would therefore have a funnel shape), wherein with the engineered landing zone fully radially expanded the engineered landing zone is substantially cylindrical (the component 640 is substantially cylindrical by having a longer length and extending down the vessel wall, see Fig. 23), and wherein the radial gap is formed between the substantially cylindrical engineered landing zone and the reverse funnel-shaped frame (the radial gap is made by the body of stent 610 being between the loop of the arms 622, 624, 626 and the landing zone 640 when expanded, see Fig. 22, [0055).
Claim 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US2016/0235525) in view of Tang (US2014/0316513) as applied to claims 1 and 10, respectively; and further in view of Shank (US2005/0110214).
Regarding claim 2, Rothstein/Tang makes obvious the method of claim 1; yet, is silent regarding wherein securing the frame to the vessel comprises adhesively securing the frame and/or the graft material attached to the frame to the vessel. Shank teaches a composite stent structure that includes adhesives to attach to the vessel wall ([0043]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the frame to include adhesives to attach to the vessel wall as taught by Shank in order to provide additional anti-migration features for the frame when implanted ([0043]).
Regarding claim 11, Rothstein/Tang makes obvious the method of claim 10; yet, is silent regarding wherein securing the frame to the vessel comprises adhesively securing the frame and/or the graft material attached to the frame to the vessel. Shank teaches a composite stent structure that includes adhesives to attach to the vessel wall ([0043]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the frame to include adhesives to attach to the vessel wall as taught by Shank in order to provide additional anti-migration features for the frame when implanted ([0043]).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US2016/0235525) in view of Tang (US2014/0316513) as applied to claim 5 above, and further in view of Manash (US2020/0000579).
Regarding claim 7, Rothstein/Tang makes obvious the method of claim 5; yet, is silent regarding wherein the landing zone graft material is different than the graft material. Manash teaches two sections of graft material or skirts that may comprise different materials ([0169]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have provided the landing zone graft material and graft material of Rothstein to be different graft materials as taught by Manash in order to impart different characteristics to the device as needed for particular requirements of the intended application ([0169]).
Regarding claim 8, Rothstein/Tang makes obvious the method of claim 5; yet, is silent regarding wherein the landing zone graft material is an extension of the graft material. Manash teaches two sections of graft material or skirts, where one section is an extension of the other ([0169]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have modified the graft materials of Rothstein such that the landing zone graft material is an extension of the graft material as taught by Manash in order to impart different characteristics to the device as needed for particular requirements of the intended application ([0169]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US2016/0235525) in view of Tang (US2014/0316513) as applied to claim 17, and further in view of Reijnen (US2020/0383770).
Rothstein/Tang makes obvious the method of claim 17; yet, is silent regarding wherein the branch stent graft is balloon expandable, and wherein radially expanding the branch stent graft comprises expanding a balloon disposed within the branch stent graft. Reijnen teaches a stent graft that may be balloon expandable or self-expandable ([0025]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have substituted the balloon expandable method of expansion as taught by King for the self-expanding stent expansion method, since it would have yielded the same result of expanding a stent graft that is deployed within a branch vessel and also providing an added benefit of a stent graft having a higher radial force ([0025]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Rothstein (US2016/0235525) as applied to claim 23 above, and further in view of Manash (US2020/0000579).
Regarding claim 24, Rothstein discloses the landing zone prosthesis of claim 23; yet, is silent regarding wherein the landing zone graft material is different than the graft material. Manash teaches two sections of graft material or skirts that may comprise different materials ([0169]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have provided the landing zone graft material and graft material of Rothstein to be different graft materials as taught by Manash in order to impart different characteristics to the device as needed for particular requirements of the intended application ([0169]).
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
No prior art of record teaches wherein the graft material includes an opening disposed therethrough, wherein the step of longitudinally translating the engineered landing zone frame comprises aligning the mobile external coupling with the opening, and wherein delivering the branch stent graft to the site comprises delivering the branch stent graft through the mobile external coupling and the opening.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799