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 .
Drawings
The drawings are objected to because Figures 1-8 are in poor quality and contain gray and black shading in Figures 1-7 and 18-20 rendering them ineligible and insufficient quality so that all details in the drawings are reproducible in the printed patent. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities: typographical errors: "woven extension" should be "woven extensions" and "supplemental warp is interlaced" should be "a supplemental warp . 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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Hulle et al. (US 20180202082 A1), in view of Du et al. US 20120165918 A1 and further in view of Greenhalgh et al. US 6159239 A.
Re. claim 1, Van Hulle discloses: A suture-free stent graft (¶ 0003, lines 3-4, annotated Figure 4), comprising a woven graft tube (126) having an inner face (annotated Fig 4) and an outer face (annotated Fig 4); and a plurality of woven extensions (item 128; [0072] describes the graft may have more than one circumferential pouch) extending from the outer face of the woven graft tube (See [0010] which teaches multiple sections including pouch share a set of fibers, item 128 extends laterally in the axial direction from the outer face of the woven graft); wherein: each of the plurality of woven extensions is integrally woven with the woven graft tube (126) at a first end and a second end (see annotated Fig. 4 illustrating first and second ends of 128 being attached to 126 and [0071] describing the graft portions and pouches are integrally woven from the same set of warp ends).
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But Van Hulle fails to disclose: that warp from the woven graft tube is de-interlaced from the woven graft tube at the first end and re-interlaced with the woven graft tube at the second end; supplemental warp is interlaced into the woven graft tube in replacement of the deinterlaced warp so as to maintain weave density in the woven graft tube under the plurality of woven extensions, and the plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extensions have independent weft from one another.
But Du discloses a similar stent graft (10). Du teaches warp (Figures 4A-B, threads 52, 27’, 27’’, 31’, and 31’’) from the woven graft tube (Figure 1, item 16) is de-interlaced from the woven graft tube at the first end (Figure 6, non-base layer 52 is de-interlaced [0110-0111]) and re-interlaced (Figure 4A to Figure 4B, Figure 1 cross-section 2-2 to cross-section 3-3, [72] and [70], Fig 4A shows strands present outside the weave and then Fig 4B show strands supplemented into weave) with the woven graft tube at the second end (Fig. 6 shows reinterlacing of supplemental strands) a supplemental warp is interlaced (Figure 6, non-base layer 52 is de-interlaced and transitions back to reinterlaced at the second end [0115]; “Notwithstanding the advantage of seamless construction provided by the present invention, textile constructions which include seams may by integrated and used together with the present invention.”) into the woven graft tube in replacement of the deinterlaced warp so as to maintain weave density in the woven graft tube under the plurality of woven extensions (Figure 6, density before a strand is removed and reintroduced into the pattern is the same).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Van Hulle to incorporate stent graft to include a supplemental warp such that warp from the woven graft tube is de-interlaced from the woven graft tube at the first end and re-interlaced with the woven graft tube at the second end; supplemental warp is interlaced into the woven graft tube in replacement of the deinterlaced warp so as to maintain weave density in the woven graft tube under the plurality of woven extensions, and the plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extensions have independent weft from one another, as suggested and taught by Du, in order to maintain weave density [0110-0111] (Van Hulle: “Notwithstanding the advantage of seamless construction provided by the present invention, textile constructions which include seams may by integrated and used together with the present invention”, anticipates the need to integrate non-seamless weaving techniques as claimed).
The combination of Van Hulle and Du discloses the invention substantially as claimed but fails to teach wherein the plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extensions have independent weft from one another.
But Greenhalgh discloses a similar stent graft (10) with woven extensions (34). Greenhalgh teaches and the plurality of woven extensions (Fig. 4A, 34 warp extension) and portions of the woven graft tube (Fig. 1,14) disposed directly under (Fig. 4A, remaining weave is disposed directly below connection point made from warp extension 34) the plurality of woven extensions have independent weft from one another (Col.4, lines 11-13) (Col.8, lines 38-49) (Prior art recites more than one weft in graft formation, allowing for independent weft as claimed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Van Hulle and Du to incorporate wherein the plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extensions have independent weft from one another, as taught and suggested by Greenhalgh, in order to allow formation of more securing points (Col. 7, lines 33-40).
Re. claim 2, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches: wherein the suture-free stent graft is free of floating yarns (Van Hulle, Figures 4 and 7 do not show floating yarn elements) forming the plurality of woven extensions (Van Hulle, Figure 4. does not include floating free yarns and Van Hulle is silent regarding this feature).
Regarding Claim 3, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches: wherein each of the plurality of woven extensions has only woven edges except where interlaced and integral with the woven graft tube (Van Hulle, ¶ 0036: “weaving technique for forming such layers integrally with the remainder of the graft body 104. Thus, the pocket flaps 114a and 114b, when formed integrally with the other layers”).
Re. claim 4, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches: wherein the plurality of woven extensions include loop (Van Hulle, 601, 602) extensions integral with the woven graft tube at only the first end and the second end, defining a plurality of through-channels (Van Hulle, “FIG.14A represents a fully threaded and partially threaded knit notation pattern using traditional loop structures.”) (Van Hulle, Figure 14B-C below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Van Hulle, Du, and Greenhalgh to include a plurality of woven extensions include loop extensions integral with the woven graft tube that define a plurality of through-channels, as further suggested and further taught by Van Hulle to improve manufacturing efficiency. Per the challenge know in the art and disclosed via Van Hulle (¶ 0003)
Regarding Claim 5, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches wherein the plurality of woven extensions include slot extensions integral with the woven graft tube (Van Hulle,100) at the first end and the second end as well as along one edge extending from the first end to the second end, defining a plurality of pockets (Van Hulle,110) (Annotated Figure 4 above)
Therefore, it would have been obvious to one of ordinary skill in the art to before the effective filing date of the claimed invention to modify the combination of Van Hulle, Du, and Greenhalgh to incorporate integrating the woven extensions as mentioned above to define a plurality of pockets, such as taught and suggested by Van Hulle to further secure stent wire (Van Hulle, [0005]).
Regarding Claim 6, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches wherein the woven graft tube is formed of 20-40 denier yarn and includes at least 150 ends per inch and at least 100 picks per inch throughout the woven graft tube (Van Hulle, ¶ 0035: “density of about 40 denier (44 decitex) or higher, less than about 40 denier, about 30 denier, or less […] 100 yarns per cm.sup.2, greater than or equal to about 150 yarns per cm.sup.2, or greater than about 177 yarns per cm.sup.2, greater than or equal to about 250 yarns per cm.sup.2”). The claimed ranges of yarns and woven graft tube density are anticipated in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claim invention to modify the combination of Van Hulle, Du, and Greenhalgh to include the claimed yarn sizes and weaving dimensions of the tube, as suggested and taught by Van Hulle to improve manufacturing (Van Hulle, [0003]).
Regarding claim 7, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches wherein the 20-40 denier yarn is polyethylene terephthalate yarn (Van Hulle, ¶ 0035: “density of about 40 denier (44 decitex) or higher, less than about 40 denier, about 30 denier, or less” and ¶ 0043:” yarns used to weave or knit the prosthetic textile device of the invention may be biologically compatible, for example natural materials such as silk and cotton, and synthetic materials such as polymers, for example polyethylene terephthalate (PET)”).
Regarding claim 8, the combination of Van Hulle, Du, and Greenhalgh as discussed above in claim 1 teaches wherein the plurality of woven extensions (Van Hullle,148,150,154) are positioned along and about, and oriented relative to, the woven graft tube (Van Hulle,140) so as to receive at least one stent wire (Van Hulle, 152,156) having a predetermined shape (Van Hulle, annotated Figure 4 above).
Regarding claim 9, the combination of Van Hulle, Du, and Greenhalgh discloses the invention substantially as claimed discussed in claim 1. Van Hulle discloses: A suture-free stent graft construct (¶ 0003, lines 3-4, Annotated Figure 4, item 144), comprising: a suture-free stent graft (¶ 0003, lines 3-4, Figure 4), comprising: a woven graft tube (126) having an inner face and an outer face (Annotated figure 4)([0009, lines 3-5; inner and outer face of the trunk wall); and a plurality of woven extensions (item128; [0072] describes the graft may have more than one circumferential pouch) extending from the outer face of the woven graft tube ((See [0010] which teaches multiple sections including pouch share a set of fibers, item 128 extends laterally in the axial direction from the outer face of the woven graft), wherein: each of the plurality of woven extensions is integrally woven ((see annotated Fig. 4 illustrating first and second ends of 128 being attached to 126 and [0071] describing the graft portions and pouches integrally woven) with the woven graft tube at a first end (146) and a second end (142);
But does not disclose: such that warp from the woven graft tube is de-interlaced from the woven graft tube at the first end and re-interlaced with the woven graft tube at the second end; supplemental warp is interlaced into the woven graft tube in replacement of the deinterlaced warp so as to maintain weave density in the woven graft tube under the plurality of woven extensions, and the plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extension have independent weft from one another; and at least one stent wire disposed about the suture-free stent graft, wherein the at least one stent wire is at least partially disposed between the woven graft tube and the plurality of woven extensions at a plurality of securement sites, securing the woven graft tube to the at least one stent wire.
But Du discloses a similar stent graft construct (10). Du teaches: such that warp (Figures 4A-B, threads 52, 27’, 27’’, 31’, and 31’’) from the woven graft tube is de-interlaced from the woven graft tube (Figure 1, item 16) at the first end (Figure 6, non-base layer 52 is de-interlaced [0110-0111]) and re-interlaced (Figure 4A to Figure 4B, Figure 1 cross-section 2-2 to cross-section 3-3, [72] and [70], Fig 4A shows strands present outside the weave and then Fig 4B show strands supplemented into weave) with the woven graft tube at the second end (Fig. 6 shows reinterlacing of supplemental strands); supplemental warp is interlaced (Figure 6, non-base layer 52 is de-interlaced and transitions back to reinterlaced at the second end [0115]; “Notwithstanding the advantage of seamless construction provided by the present invention, textile constructions which include seams may by integrated and used together with the present invention.”) into the woven graft tube in replacement of the deinterlaced warp so as to maintain weave density in the woven graft tube under the plurality of woven extensions (Figure 6, density before a strand is removed and reintroduced into the pattern is the same),
The combination of Van Hulle and Du discloses the invention substantially as claimed but fails to teach and the plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extension have independent weft from one another; and at least one stent wire disposed about the suture-free stent graft, wherein the at least one stent wire is at least partially disposed between the woven graft tube and the plurality of woven extensions at a plurality of securement sites, securing the woven graft tube to the at least one stent wire.
But Greenhalgh discloses a similar stent graft (10) with woven extensions (34). Greenhalgh teaches and the plurality of woven extensions (Fig. 4A, 34 warp extension) and portions of the woven graft tube (Fig. 1,14) disposed directly under the plurality of woven extension (Fig. 4A, remaining weave is disposed directly below connection point made from warp extension 34) have independent weft from one another (Col.8, lines 38-49) (Prior art recites more than one weft in graft formation, allowing for independent weft as claimed); and at least one stent wire disposed about the suture-free stent graft, wherein the at least one stent wire (Fig. 4A, 26)is at least partially disposed between the woven graft tube and the plurality of woven extensions at a plurality of securement sites (Fig. 4A, 38), securing the woven graft tube to the at least one stent wire.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the combination of Van Hulle and Du to incorporate a plurality of woven extensions and portions of the woven graft tube disposed directly under the plurality of woven extension have independent weft from one another; and at least one stent wire disposed about the suture-free stent graft, wherein the at least one stent wire is at least partially disposed between the woven graft tube and the plurality of woven extensions at a plurality of securement sites, securing the woven graft tube to the at least one stent wire, as taught and suggested by Greenhalgh, in order to allow formation of more securing points (Col. 7, lines 33-40).
Regarding claim 10, Combination of Van Hulle, Du, and Greenhalgh discussed above in claim 9 teaches: the plurality of woven extensions include loop extensions integral with the woven graft tube at only the first end and the second end, defining a plurality of through-channels (Van Hulle ¶ 0063: “one circumferential pouch with a slit opening on a woven edge of an integrally woven longitudinal tubular graft portion”) (Van Hulle, Figure 7B), and the at least one stent wire (22) passes through the plurality of through-channels (Van Hulle ¶ 0033: “an element, such as a radiopaque marker (e.g., a wire), may be disposed or threaded through one slit opening in a pouch”).
Regarding claim 11, the combination of Van Hulle, Du, and Greenhalghas discussed above in claim 9 teaches: wherein the plurality of woven extensions include slot extensions (Van Hulle, 602) integral with the woven graft tube (100) at the first end and the second ends well as along one edge extending from the first end to the second end, defining a plurality of pockets, (Van Hulle, see Figure 14B.) and the at least one stent wire (Van Hulle, 152) is partially disposed within the plurality of pockets (van Hulle,148) (Van Hulle, Figure 7B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799