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 .
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.
Response to Amendment
This action is in response to the applicant’s amendment received 8/12/2025. Claims 15-25 and 27-34 are pending. Claim 26 has been canceled.
Response to Arguments
Applicant's arguments filed 12 August 2025 have been fully considered but they are not persuasive. Claim 15 has been amended to require the fiber promotes thrombosis within an aneurysm. Applicant argues that in order for the fibers to promote thrombosis within an aneurysm, it is necessary that the fibers extend away and additionally are positioned so that they can extend into the aneurysm and that this is contrary to the teaching of Gravett because according to Gravett the fibers are positioned in an area distanced from the aneurysm to seal off blood supply. Applicant points to [0007] and [0122] to support the conclusion that one of ordinary skill in the art would not be prompted to attach fibers to the endoprosthesis of Aboul-Hosn in a way that thrombosis in an aneurysm is promoted. Examiner respectfully disagrees. Gravett et al. teaches in paragraph [0054] that the fibers extend away from the stent graft (see also Fig. 4) and can be positioned to completely cover the exterior of the stent-graft. Further, in contrast to Applicant’s arguments, Fig. 4 illustrate threads positioned away from the ends of the endoprosthesis, thereby the threads are positioned to extend into an aneurysm. Therefore, it is the examiner’s position that Gravett teaches fibers configured to extend as claimed such that the fibers promote thrombosis within an aneurysm and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach fibers to the endoprosthesis of Aboul-Hosn as taught by Gravett.
Claim Objections
Claim 15 is objected to because of the following informalities: typographical error. Lines 6-7 should be amended as follows: “the surface of the graft and stent structure”. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Claims 15-25 and 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosn (US Pub. No. 2005/0143801) in view of Gravett et al. (US Pub. No. 2010/0222863).
Regarding claim 15, Aboul-Hosn discloses an endoprosthesis (10; see Fig. 2) comprising a graft (14; see Fig. 2 and [0091]), a stent structure (12; see Fig. 2 and [0091]), and a suture (24), wherein the suture (24) fixedly attaches the stent structure (12) to the graft (14; see Fig. 2 and [0095]).
Aboul-Hosn fails to disclose a fiber, wherein the fiber is attached to the endoprosthesis via the suture, wherein the fiber is a thrombogenic fiber having a free portion configured to extend at least partly away from at least one of the stent structure and a surface of the graft, the fiber having a free end that extends a distance outwardly away from the surface of the graft and stent structure, such that the fiber promotes thrombosis within an aneurysm. Gravett also discloses an endoprosthesis (see Fig. 4 and [0054]). Gravett teaches a fiber (thread), wherein one or more points along the fiber can be attached to the endoprosthesis by using one or more sutures to sew the fiber onto the endoprosthesis (see [0051], [0054-0055], and Fig. 4), wherein the fiber is a thrombogenic fiber (see [0073] describing the threads yield thrombotic events, thereby the threads are thrombogenic fibers) having a free portion configured to extend at least partly away from at least one of the stent structure and a surface of the graft (the free portion being one or both unattached ends that extends away from the stent graft; see Fig. 4), the fiber having a free end that extends a distance outwardly away from the surface of the graft and stent structure such that the fiber promotes thrombosis within an aneurysm (see [0054] and Fig. 4).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Aboul-Hosn’s endoprosthesis with a fiber, wherein the fiber is attached to the endoprosthesis via the suture (24) as suggested by Gravett, and wherein the fiber is a thrombogenic fiber having a free portion configured to extend at least partly away from at least one of the stent structure and a surface of the graft, the fiber having a free end that extends a distance outwardly away from the surface of the graft and stent structure, such that the fiber promotes thrombosis within an aneurysm, as taught by Gravett. Doing so would provide a means to enhance cellular proliferation which helps to maintain the stent graft in place within the vessel (see [0056]).
Regarding claim 16, Aboul-Hosn as modified discloses the suture (24) has a knot (see Fig. 2 and [0095] describing the sutures are tied off).
Regarding claim 17, Aboul-Hosn as modified discloses the knot forms the suture (24) into a substantially closed loop holding together the stent structure (12) and the graft (14; see Fig. 2).
Regarding claim 18, Aboul-Hosn as modified discloses the knot connects the suture to the fiber (thread of Gravett; since the knot forms a closed loop suture 24, the knot connects the suture to the fiber, graft, and stent structure).
Regarding claim 19, Aboul-Hosn as modified discloses the fiber (thread of Gravett) forms a loop around the suture (see [0055] of Gravett describing the fiber may be a looped bundle, in which case the looped bundle forms a loop around the closed loop attached suture 24 of Aboul-Hosn).
Regarding claim 20, Aboul-Hosn as modified discloses the suture (24) forms a continuous stitch (see Fig. 2, wherein the closed loop suture is continuous).
Regarding claim 21, Aboul-Hosn as modified discloses the suture (24) forms a buttonhole stitch (see Fig. 2, wherein the suture forms a closed loop, thereby is a buttonhole stitch as claimed).
Regarding claim 22, Aboul-Hosn as modified discloses the continuous stitch holds the stent structure (12) and the graft (14) together (see Fig. 2 and [0095]).
Regarding claim 23, Aboul-Hosn as modified discloses at least two fibers (threads of Gravett), wherein the at least two fibers are connected via a support string (see [0050] of Gravett describing the fibers may be processed into a woven or knitted material that can be attached to the stent graft, thereby comprising a plurality of fibers, one of which being considered a support string as claimed since it is a thread that is part of the woven or knitted material).
Regarding claim 24, Aboul-Hosn as modified discloses the fiber (thread of Gravett) comprises a knot connecting the fiber to the suture (see [0051] of Gravett describing the fibers may be connected to the endoprosthesis via knotting).
Regarding claim 25, Aboul-Hosn as modified discloses the fiber (thread of Gravett) is attached to the stent structure (12) and to the graft (14) via the suture (as modified, the tied-off suture 24 attaches the fiber, stent, and graft together).
Regarding claim 27, Aboul-Hosn as modified discloses the fiber (thread of Gravett) is distinct from at least one of the suture (24) and the graft (14).
Regarding claim 28, Aboul-Hosn as modified discloses the suture (24) is configured to retain attachment of the fiber (thread of Gravett) after implantation of the endoprosthesis (see Fig. 2 and [0095] describing the suture is tied off, thereby configured as claimed).
Regarding claim 29, Aboul-Hosn as modified discloses a method of manufacturing an endoprosthesis (10) according to claim 15 (see rejection above) comprising the steps of providing a stent structure (12; see Fig. 2 and [0091]), a graft (14; see Fig. 2 and [0091]), and a suture (24), attaching the stent structure (12) to the graft (14) via the suture (24; see Fig. 2 and [0095]), and attaching at least one fiber to the endoprosthesis via the suture (the modification yields attaching the fibers to the endoprosthesis via sutures 24 as claimed; see the rejection of claim 15 above for details).
Regarding claim 30, Aboul-Hosn as modified discloses the step of attaching at least one fiber (threads of Gravett) to the endoprosthesis via the suture (24) comprises attaching the at least one fiber to the suture (as modified the tied-off suture 24 attaches the suture to the at least one fiber, stent, and graft).
Regarding claim 31, Aboul-Hosn as modified discloses the step of attaching at least one fiber (threads of Gravett) to the endoprosthesis via the suture (24) comprises attaching the at least one fiber via at least one of a loop, a knot, and a support string comprised by at least one of the at least one fiber and the suture (see Fig. 2 of Aboul-Hosn illustrating the tied-off suture 24 forms a loop and a knot, thereby as modified the at least one fiber is attached via a loop and knot of the suture).
Regarding claim 32, Aboul-Hosn as modified discloses the step of attaching comprises attaching the at least one fiber (threads of Gravett) to the stent structure (12) and to the graft (14) via the suture (as modified the tied-off suture 24 attaches the at least one fiber, stent, and graft together).
Regarding claim 33, Aboul-Hosn as modified discloses the at least one fiber (threads of Gravett) is a thrombogenic fiber (see [0073] of Gravett describing the threads yield thrombotic events, thereby are thrombogenic fibers).
Regarding claim 34, Aboul-Hosn as modified discloses the fiber comprises or consists of a material selected from Dacron, polyethylene, polypropylene, polytetrafluoroethylene, a polyamide, polyglycolic-lactic acid (see [0059] of Gravett).
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 MELANIE TYSON whose telephone number is (571)272-9062. The examiner can normally be reached M-F 8:00 AM - 4:00 PM (ET).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774