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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 13-15 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2017/0273809 A1 (hereinafter, “Marmur”).
In regards to claim 1, Marmur teaches a branchable stent graft (Fig. 1A, endovascular stent-graft, 20, para 0051) comprising:
a tubular body (Fig. 1B, main tube, 40, para 0065)
extending along a longitudinal axis (see below, annotated Fig. 6A)
and including proximal and distal ends (see below, Fig. 6A, proximal end, PE, and distal end, DE); and stents (Fig. 2A, stent springs, 88, para 0065) attached to and supporting the tubular body (Fig. 1B, main tube, 40, para 0065) and including first and second stents (Fig. 2A, stent springs, 88, para 0065)
the stents circumferentially extending around the tubular body (Fig. 1B, stent spring, 88, shown in figure wrapping main tube, 40, para 0065-0066),
the first and second stents spaced apart along the longitudinal axis of the tubular body (Fig. 2A, stent springs, 88, para 0065)
and the first stent ( Fig. 1, stent springs, 88, para 0065) including alternating crests and troughs forming peaks and valleys therebetween (see below, annotated Fig. 1A, Peaks, P1, in combination with valleys, V1),
the tubular body including access regions arranged circumferentially spaced around the tubular body (Fig. 3A, lateral tube, 50, and second lateral tube, 150, para 0075)
the access regions confined within the peaks and/or valleys of the first stent (Fig. 3A, lateral tube, 50, in combination with stent cells, 90, para 0074-0075),
including peripheries (Fig. 1A, strut members, 30, para 0055) defining openings (Fig. 3A, first lateral lumen, 62, second lateral lumen, 162, para 0075) covered with graft material regions (Fig. 1A, flexible sheets, 34, para 0057).
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In regards to claim 2, Marmur further discloses, wherein the access regions (Fig. 3A, lateral tube, 50, and second lateral tube, 150, para 0075) are branches having peripheral sides extending (Fig. 9, branch prosthesis, 164, para 0046)(see below, annotated Fig. 6B, PS) between proximal (see below, annotated Fig. 6B, BPE) and distal ends of the branches, and the distal ends forming the openings (see below, annotated Fig. 6B, BDO).
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In regards to claim 3, Marmur further discloses, wherein the graft material regions (Fig. 1A, flexible sheets, 34, para 0057) are spaced apart from the tubular (Fig. 1B, main tube, 40, para 0065) and aligned with the distal ends of the branches (see above, annotated Fig. 6B, BPE).
4. In regards to claim 4, Marmur further discloses, wherein the access regions (Fig. 3A, lateral tube, 50, and second lateral tube, 150, para 0075) are branches having peripheral sides nested (Fig. 1B, lateral tube, 50, para 0059) within the openings (Fig. 3A, first lateral lumen, 62, second lateral lumen, 162, para 0075) when the branchable stent graft is in a delivery state (Fig. 1B, lateral tube, 50, in combination with strut members, 30, para 0063) and the peripheral sides extend away from the openings when the branchable stent graft is in a deployed state (Fig. 1A, lateral tube, 50, para 0064).
5. In regards to claim 5, Marmur further discloses, wherein the access regions are fenestrations (Fig. 3A, first lateral lumen, 62, second lateral lumen, 162, para 0075) bounded by the peripheries (Fig. 1A, strut members, 30, para 0055) and covered with the graft material regions (Fig. 1A, flexible sheets, 34, para 0057).
6. In regards to claim 6, Marmur further discloses, wherein at least a portion the graft material regions (Fig. 1A, flexible sheets, 34, para 0057) are even with the tubular body (Fig. 1B, main tube, 40, in combination with junction, 60, para 0052 and para 0065).
7. In regards to claim 7, Marmur further discloses, wherein the graft material regions (Fig. 1A, flexible sheets, 34, para 0057) follow the contour of the tubular body (Fig. 1B, main tube, 40, para 0065).
In regards to claim 8, Marmur further discloses, wherein the access regions (Fig. 3A, lateral tube, 50, and second lateral tube, 150, para 0075) include first access regions (Fig. 3A, lateral tube, 50,) circumferentially spaced around a first circumferential region (see below, annotated Fig. 6B, FCR, para 0088) of the tubular body (Fig. 6B, main tube, 40, para 0088) aligning with a first branch artery (Fig. 6B, brachiocephalic artery, 503, para 0088) of a main artery (Fig. 6B, aortic arch, 500, para 0088) in a deployed state and second access regions (Fig. 6B, second lateral lumen, 162, para 0075) circumferentially spaced around a second circumferential region of the tubular body (see below, annotated Fig. 6B, SCR, para 0088) aligning with a second branch artery (Fig. 6B, left common carotid artery, 512, para 0088) of the main artery (Fig. 6B, aortic arch, 500, para 0088) in the deployed state.
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9. In regards to claim 9, Marmur further discloses, wherein the first circumferential region (see above, annotated Fig. 6B, FCR) and the second circumferential region (see above, annotated Fig. 6B, SCR) are spaced apart (see above, Fig. 6B).
In regards to claim 10, Marmur further discloses, a branchable stent graft (Fig. 1A, endovascular stent-graft, 20, para 0051) comprising:
a tubular body (Fig. 1A, main tube, 40, para 0052)
extending along a longitudinal axis (see below, annotated Fig. 6A)
and including proximal and distal ends (see below, Fig. 6A, proximal end, PE, and distal end, DE);
and an interconnected stent ( Fig. 1B, stent spring, 88, shown in figure wrapping main tube, 40, para 0065-0066)
attached to and supporting the tubular body and forming separated access regions (Fig. 3A, lateral tube, 50, and second lateral tube, 150, para 0075) within the interconnected stent arranged circumferentially spaced around the tubular body (Fig. 1A, main tube, 40, in combination with stent springs, 88, para 0052) the separated access regions including peripheries (Fig. 1A, strut members, 30, para 0055) defining openings (Fig. 3A, first lateral lumen, 62, second lateral lumen, 162, para 0075) covered with graft material regions (Fig. 1A, flexible sheets, 34, para 0057).
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11. In regards to claim 11, Marmur further discloses, wherein the separated access regions include first and second access regions (see below, annotated Fig. 6B, FAR and SAR) separated by a portion of the interconnected stent (see below, annotated Fig. 6B).
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13. In regards to claim 13, Marmur further discloses, wherein the separated access regions (see above, annotated Fig. 6B, SAR and FAR )
include branches (see below, annotated Fig. 6B, BPE in combination with BDO, para 0091)
having peripheral sides (see below, annotated Fig. 6B, PS) extending from proximal ends of the branches (Fig. 6B, branched stent graft in combination with carotid artery, 512, and brachiocephalic artery, 503, para 0091),
and the distal ends forming openings (see below, annotated Fig. 6B, BDO).
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14. In regards to claim 14, Marmur further discloses, wherein the separated access regions (see below, annotated Fig. 6B, FAR and SAR) are fenestrations (Fig. 3A, first lateral lumen, 62, second lateral lumen, 162, para 0075) bounded by the peripheries (Fig. 1A, strut members, 30, para 0055)and covered with the graft material regions (Fig. 1A, flexible sheets, 34, para 0057).
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15. In regards to claim 15, Marmur further discloses, wherein the separated access regions (see above, annotated Fig. 6B, FAR and SAR) include first access regions (see above, annotated Fig. 6B, FAR, para 0075) circumferentially spaced around a first circumferential region (see below, annotated Fig. 6B, FCR, para 0088) of the tubular body (Fig. 6B, main tube, 40, para 0088) aligning with a first branch artery (Fig. 6B, brachiocephalic artery, 503, para 0088) of a main artery (Fig. 6B, aortic arch, 500, para 0088) in a deployed state and second access regions (Fig. 6B, second lateral lumen, 162, para 0075) circumferentially spaced around a second circumferential region (see below, annotated Fig. 6B, SCR, para 0088) of the tubular body (see below, annotated Fig. 6B, SCR, para 0088) aligning with a second branch artery (Fig. 6B, left common carotid artery, 512, para 0088) of the main artery (Fig. 6B, aortic arch, 500, para 0088) in the deployed state, and the interconnected stent (Fig. 6B, stent graft, 120, para 0088) spanning the first and second circumferential regions (see below, annotated Fig. 6B, FCR and SCR).
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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 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0273809 A1 (hereinafter, “Marmur”) as applied to claim 1-11 above, and further in view of US 6,520,987 (hereinafter, "Plante").
In regards to claim 12, Marmur teaches the branchable stent graft (Fig. 1, vascular prosthesis, 10, para 0036) (Fig. 1A, endovascular stent-graft, 20, para 0051) of claim 10, with the interconnected stent (Fig. 13, vascular prosthesis, 180, in combination with luminal graft component, 208, para 0049)( Fig. 6B, stent graft, 120, para 0088). However, Marmur does not teach the interconnected stent has a honeycomb pattern.
Plante teaches the interconnected stent (Fig. 1, stent, 10, col. 9 lines 16-21 ) has a hexagonal cell design (Fig. 1, hexagon ring element, 3, col. 9 lines 27-30). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the interconnected stent of Marmur with the honeycomb pattern of Plante in order to provide optimal wall coverage after deployment and to limit the longitudinal shortening after expansion (col. 11 lines 54- col. 12, line 10).
Claim(s) 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0273809 A1 (hereinafter, “Marmur”) and US 2010/0106175 A1 (hereinafter, “McLachlan”) .
16. In regards to claim 16, Marmur teaches a method of deploying a branchable stent graft (Fig. 1A, endovascular stent-graft, 20, para 0051) in a main artery (Fig. 6B, aortic arch, 500, para 0088) branching into a branch artery (Fig. 6B, brachiocephalic artery, 503, para 0088),
the method comprising: delivering a branchable stent graft (endovascular stent-graft, 120, para 0089) in a constrained state (para 0089), the stent graft including a tubular body (Fig. 1A, main tube, 40, in combination with stent-graft, 20, para 0052)
extending along a longitudinal axis (see below, annotated Fig. 6A) and one or more stents attached to and supporting the tubular body (Fig. 1A, main tube, 40, para 0052), the tubular body including access regions (see below, annotated Fig. 6B, FAR and SAR) including peripheries (Fig. 1A, strut members, 30, para 0055) defining openings (Fig. 3A, first lateral lumen, 62, second lateral lumen, 162, para 0075) covered with graft material regions (Fig. 1A, flexible sheets, 34, para 0057), the access regions including a first access region (see below, annotated Fig. 6B, FAR, para 0088) defining a first periphery (see below, Fig. 6B, FP, para 0088) defining a first opening covered with a first graft material region and a second access region (see below, annotated Fig. 6B, SAR, para 0088) defining a second periphery (see below, Fig. 6B, SP, para 0088) defining a second opening covered with a second graft material region (Fig. 1A, flexible sheets, 34, para 0057); deploying the branchable stent graft (Fig. 6B, stent graft, 120, para 0089) at a deployment site (Fig. 14A-C, aneurysm, 243, para 0053, prosthesis is deployed at aneurysm site)(para 0089, deployed at desired anatomical site) within the main artery by transitioning the branchable stent graft from the constrained state into an expanded state (Fig. 6B, para 0089, radially expanded state); the deployment site (para 0089, deployed at desired anatomical site), the first access region being closer than the second access region to the branch artery (see below, annotated Fig. 6B, FAR, in combination with SAR, para 0088-0090); and extending a branch stent graft through the first opening and into the branch artery (see below, annotated Fig. 6B, FAR, in combination with artery 503, para 0088-0090);.
However, Marmur does not explicitly disclose at least partially removing the first graft material region from the first access region and the deployment site. McLachlan teaches a branchable stent graft (Fig. 4, graft, 41, para 0137) wherein at least partially removing the first graft material region (para 0021) from the first access region and the deployment site (para 0114). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the branchable stent graft of Marmur with the removal process of McLachlan to allow for adjustments to be made in endograft procedures where the graft covers a vessel side-branch (para 0110).
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17. In regards to claim 17, modified Marmur further discloses wherein the deploying step includes maintaining the first graft material region (Fig. 1A, flexible sheets, 34, para 0057) even with the tubular body in an initial deployed state (Fig. 3B, arcuate members, 70, para 0081, radially compressed state) and moving the first graft material region (Fig. 1A, flexible sheets, 34, para 0057) into a final deployed state (Fig. 3A, arcuate members, 70, para 0079, radially expanded state) where the first graft material region (Fig. 1A, flexible sheets, 34, para 0057) is spaced apart from the tubular body.
18. In regards to claim 18, modified Marmur further teaches wherein the first access region (see above, annotated Fig. 6B, FAR) the access region has a first peripheral side (Fig. 3B, arcuate members, 70 in combination with linking member 84, para 0079 ) nested and collapsed within the first opening when the stent graft (Fig. 3B, stent-graft, 120, para 0072) is in the initial deployed state (Fig. 3B, arcuate members, 70, para 0081, radially compressed state).
19. In regards to claim 19, modified Marmur further teaches the second graft material region (Fig. 1A, flexible sheets, 34, para 0057) within the second access region (see above, annotated Fig. 6B, SAR, para 0088) in the final deployed state (Fig. 3A, arcuate members, 70, para 0079, radially expanded state).
20. In regards to claim 20, modified Marmur further discloses, wherein the removing step is performed using an in-situ fenestration process (McLachlan, para 0017, para 0092). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the branchable stent graft of Marmur with the in-situ removal process of McLachlan to allow for adjustments to be made in endograft procedures where the graft covers a vessel side-branch (para 0110).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 10,905,541 B2 (hereinafter, "Bradway"), teaches an endoluminal prosthesis system teaches fenestrations, with a variety of possible geometries, biocompatible graft material, and multiple passageways on the circumferential side of the graft to communicate with arteries.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0269497 A1 (hereinafter, "Arbefeuille"), teaches a branchable stent graft with branch prosthesis and biocompatible graft material, and multiple passageways on the circumferential side of the graft to communicate with arteries.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/J.M.S./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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