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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/28/2026 has been entered. Claims 15-19, 21-25, and 27-34 are pending.
Response to Arguments
Applicant’s arguments filed 1/28/2026 with respect to amended claim 15 have been considered but are moot in view of the new grounds of rejection set forth below.
Claim Objections
Claims 21 and 22 are objected to because of the following informalities: claims 21 and 22 depend from canceled claim 20. Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-19, 21-25, and 27-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 15 has been amended to require “wherein the suture forms a continuous stitch with at least two stitches”. Applicant points to Fig. 5-6 for support of this limitation on page 5 of the remarks received 1/28/2026. However, paragraph [0040] of the PGPUB instant specification describes Figs. 5-6 illustrating a buttonhole stitch comprising loop portions 7’, a knot portion 7, and a loop-connecting portion 7”. Therefore, Figs. 5-6 illustrate a continuous stitch with two loop portions not “two stitches” as stated in the remarks and as now recited in amended claim 15. Further, the specification does not provide support for a suture forming a continuous stitch with more than two stitches (or loops) which the phrase “at least two” encompasses. For these reasons, the limitation is considered new matter.
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 15-19, 21-25, and 27-34 are rejected under 35 U.S.C. 103 as being unpatentable over Havel (US Pub. No. 2014/0236280) in view of Gravett et al. (US Pub. No. 2010/0222863).
Regarding claim 15, Havel discloses an endoprosthesis (10; see Fig. 1) comprising a graft (30; Figs. 1, 3A-3B), a stent structure (25 formed from stent wire 20; see [0018] and Fig. 1, 3C), and a suture (64; Fig. 2C), wherein the suture (64) fixedly attaches the stent structure to the graft (see Fig. 2C and [0023]), wherein the suture (64) forms a continuous stitch with at least two stitches (see Fig. 2C and [0023]). Havel 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 Havel’s endoprosthesis (10) with a fiber, wherein the fiber is attached to the endoprosthesis (10) via the suture (64) 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, Havel as modified discloses the suture (64) has a knot (see Fig. 2C and [0022] describing the sutures may be tied or knotted).
Regarding claim 17, Havel as modified discloses the knot forms the suture (64) into a substantially closed loop holding together the stent structure (25 formed from stent wire 20) and the graft (30; see Fig. 2C and [0023]).
Regarding claim 18, Havel as modified discloses the knot connects the suture (64) to the fiber (thread of Gravett; since the knot forms a closed loop suture, the knot connects the suture to the fiber, graft, and stent structure).
Regarding claim 19, Havel 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 64 of Havel).
Regarding claim 21, Havel as modified discloses the suture (64) forms a buttonhole stitch (see Fig. 2C, wherein the suture forms a continuous stitch with two connected loops and knots, thereby is a buttonhole stitch as claimed).
Regarding claim 22, Havel as modified discloses the continuous stitch holds the stent structure (25 formed from stent wire 20) and the graft (30) together (see Fig. 2C and [0023]).
Regarding claim 23, Havel 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, Havel 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, Havel as modified discloses the fiber (thread of Gravett) is attached to the stent structure (25 formed from stent wire 20) and to the graft (30) via the suture (as modified, the tied or knotted suture 64 attaches the fiber, stent, and graft together).
Regarding claim 27, Havel as modified discloses the fiber (thread of Gravett) is distinct from at least one of the suture (64) and the graft (30).
Regarding claim 28, Havel as modified discloses the suture (64) is configured to retain attachment of the fiber (thread of Gravett) after implantation of the endoprosthesis (see Fig. 2C and [0022] describing the suture is tied or knotted, thereby configured as claimed).
Regarding claim 29, Havel 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 (25 formed from stent wire 20), a graft (30), and a suture (64), attaching the stent structure to the graft via the suture (see Fig. 2C and [0023]), and attaching at least one fiber to the endoprosthesis via the suture (the modification yields attaching the fibers to the endoprosthesis via sutures 64 as claimed; see the rejection of claim 15 above for details).
Regarding claim 30, Havel as modified discloses the step of attaching at least one fiber (threads of Gravett) to the endoprosthesis via the suture (64) comprises attaching the at least one fiber to the suture (as modified the tied or knotted suture 64 attaches the suture to the at least one fiber, stent, and graft).
Regarding claim 31, Havel as modified discloses the step of attaching at least one fiber (threads of Gravett) to the endoprosthesis via the suture (64) 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. 2C of Havel illustrating the tied or knotted suture 64 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, Havel as modified discloses the step of attaching comprises attaching the at least one fiber (threads of Gravett) to the stent structure (25 formed from stent wire 20) and to the graft (30) via the suture (as modified the tied or knotted suture 64 attaches the at least one fiber, stent, and graft together).
Regarding claim 33, Havel 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, Havel 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
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
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