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.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh (US-20100094404) in view of Scanlon (US-20070207186).
Regarding claim 1, Greenhalgh teaches:
A method of fabricating a docking device ([0013] and [0114]; Figs. 1 and 8, #10), the method comprising:
implementing a three-dimensional (3D) weaving technique to form a 3D textile structure using a plurality of different types of fibers ([0009] – [0012], [0039], [0080], [0084] – [0104], [0108], [0112], and [0135] – [0136]; Fig. 7);
heating the 3D textile structure on a shape-setting mold to set a cylindrical shape of the 3D textile structure ([0078] and [0123]; Fig. 1, #20); and
removing the 3D textile structure from the shape-setting mold ([0107]; Fig. 1, #10 and #20).
Greenhalgh does not explicitly teach:
heating the structure at a temperature above a melting point of a first type of fiber of the plurality of different types of fibers; and
maintaining the 3D textile structure on the shape-setting mold to cool off for a period of time.
However, Scanlon, in a similar field of endeavor, a method of fabricating a stent device, teaches:
heating the structure at a temperature above a melting point of a first type of fiber of the plurality of different types of fibers ([0272], [0339] – [0340], [0350] – [0351], [0376] – [0379], and [0386]); and
maintaining the 3D textile structure on the shape-setting mold to cool off for a period of time ([0322], [0356], [0373] – [0375], and [0379]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heating step of Greenhalgh to incorporate the teachings of Scanlon and include a step of explicitly heating at a temperature above a melting point of a first type of fiber of the plurality of different types of fibers and then a cooling step. The purpose, as stated by Scanlon, being to bind the fibers ([0386]).
Regarding claim 2, Greenhalgh in view of Scanlon teaches the limitations of claim 1, which claim 2 depends on. Scanlon further teaches:
covering a compressible filler structure with fabric ([0217]); and
attaching the fabric to an outer surface of the 3D textile structure ([0090], [0114], [0132], and [0176]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of Greenhalgh in view of Scanlon to further incorporate the teachings of Scanlon and include a step of covering a structure with fabric and attaching it to an outer surface of the textile structure. The purpose, as stated by Scanlon, being the multilayer wall thickness expanded tubular profile, of course, can be optionally converted into the expanded sheet or expanded fiber ([0090]).
Regarding claim 3, Greenhalgh in view of Scanlon teaches the limitations of claim 2, which claim 3 depends on. Scanlon further teaches:
wherein the fabric comprises 3D woven fabric ([0114]).
Regarding claim 4, Greenhalgh in view of Scanlon teaches the limitations of claim 3, which claim 4 depends on. Scanlon further teaches:
wherein the 3D woven fabric has a similar structure and composition as the 3D textile structure ([0090], [0114], [0132], and [0176]).
Regarding claim 5, Greenhalgh in view of Scanlon teaches the limitations of claim 1, which claim 5 depends on. Greenhalgh further teaches:
wherein said implementing the 3D weaving technique involves interlacing shape memory fibers ([0091], [0141] – [0142], [0155], and [0161]), low-melt thermoplastic fibers ([0084] – [0094]), and high-tenacity biocompatible material fibers ([0084] – [0094]).
Regarding claim 6, Greenhalgh in view of Scanlon teaches the limitations of claim 1, which claim 6 depends on. Greenhalgh further teaches:
wherein the 3D weaving technique is one of:
an orthogonal weaving technique;
a multilayer weaving technique ([0112]); or
an angle-interlock weaving technique.
Regarding claim 7, Greenhalgh in view of Scanlon teaches the limitations of claim 1, which claim 7 depends on. Greenhalgh further teaches:
further comprising wrapping the 3D textile structure around the shape-setting mold to form the 3D textile structure in a hollow cylindrical form ([0080], [0095], [0104], [0108], [0112], and [0116]; Figs. 3-4, #13 and #20).
Regarding claim 9, Greenhalgh teaches:
A method of fabricating a docking device ([0013] and [0114]; Figs. 1 and 8, #10), the method comprising:
weaving a three-dimensional (3D) woven fabric ([0009] – [0012], [0039], [0080], [0084] – [0104], [0108], [0112], and [0135] – [0136]; Fig. 7) by interlacing a shape memory material ([0091], [0141] – [0142], [0155], and [0161]), a low-melt thermoplastic polymer or resin ([0084] – [0094]), and a high-tenacity biocompatible material ([0084] – [0094]); and
pressing and heating the 3D woven fabric over a shape-setting mold ([0078], [0107], and [0123]; Fig. 1, #10 and #20).
Greenhalgh does not explicitly teach:
heating the structure at a temperature above a melting point of the low-melt thermoplastic polymer or resin.
However, Scanlon, in a similar field of endeavor, a method of fabricating a stent device, teaches:
heating the structure at a temperature above a melting point of the low-melt thermoplastic polymer or resin ([0272], [0339] – [0340], [0350] – [0351], [0376] – [0379], and [0386]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heating step of Greenhalgh to incorporate the teachings of Scanlon and include a step of explicitly heating at a temperature above a melting point of the low melt polymer or resin. The purpose, as stated by Scanlon, being to bind the fibers ([0386]).
Regarding claim 11, Greenhalgh in view of Scanlon teaches the limitations of claim 9, which claim 11 depends on. Scanlon further teaches:
further comprising attaching a filler structure to a surface of the 3D woven fabric ([0090], [0114], [0132], [0176], and [0217]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of Greenhalgh in view of Scanlon to further incorporate the teachings of Scanlon and include a step of attaching a filler structure to a surface of the 3D woven fabric. The purpose, as stated by Scanlon, being the multilayer wall thickness expanded tubular profile, of course, can be optionally converted into the expanded sheet or expanded fiber ([0090]).
Regarding claim 12, Greenhalgh in view of Scanlon teaches the limitations of claim 11, which claim 12 depends on. Scanlon further teaches:
wherein said attaching the filler structure comprises sewing the filler structure to an outer surface of the 3D woven fabric ([0166] – [0167] and [0289]).
Regarding claim 13, Greenhalgh in view of Scanlon teaches the limitations of claim 12, which claim 13 depends on. Scanlon further teaches:
further comprising covering the filler structure with a tubular woven fabric comprising PET ([0194] – [0195] and [0271]), wherein the filler structure comprises polymer foam ([0176], [0217], [0274], and [0281]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh (US-20100094404) in view of Scanlon (US-20070207186), as applied to claim 1 above, and further in view of Wangenheim (US-20100183836).
Regarding claim 8, Greenhalgh in view of Scanlon teaches the limitations of claim 1, which claim 8 depends on, but does not explicitly teach wherein the temperature is below melting points of second and third types of fiber of the plurality of different types of fibers. However, Wangenheim (US-20100183836), in a similar field of endeavor, a method of weaving a 3D textile structure comprising a plurality of different types of fibers, teaches:
wherein the temperature is below melting points of second and third types of fiber of the plurality of different types of fibers ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heating temperature of Greenhalgh in view of Scanlon to incorporate the teachings of Wangenheim and have the temperature be below melting points of second and third types of fiber of the plurality of different types of fibers. The purpose, as stated by Wangenheim, being in order to increase the load bearing capacity of the composite fabric product ([0061]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh (US-20100094404) in view of Scanlon (US-20070207186), as applied to claim 9 above, and further in view of Goiz (US-20140113519).
Regarding claim 10, Greenhalgh in view of Scanlon teaches the limitations of claim 9, which claim 10 depends on. Scanlon further teaches:
wherein:
the shape memory material comprises nitinol ([0180] and [0243]);
the high-tenacity biocompatible material comprises polyethylene terephthalate (PET) ([0194] – [0195] and [0271]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the materials of Greenhalgh in view of Scanlon to further incorporate the teachings of Scanlon and use nitinol and PET. The purpose, as stated by Scanlon, being that one way of providing the expanded material, reinforcement, or combinations thereof with shape memory is to include one or more materials in these components with shape memory characteristics ([0243]), and the material used to manufacture the expanded material of the present invention is preferably a polymer but it can be any natural or synthetic material capable of formation into a tubular profile, sheet, fiber, or combinations thereof ([0194]).
Greenhalgh in view of Scanlon does not explicitly teach:
the low-melt thermoplastic polymer or resin comprises nylon having a melting point of between 85 degrees Celsius and 200 degrees Celsius.
However, Goiz, in a similar field of endeavor, a method of weaving a 3D textile structure comprising a plurality of different types of fibers, teaches:
the low-melt thermoplastic polymer or resin comprises nylon having a melting point of between 85 degrees Celsius and 200 degrees Celsius ([0056] and [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermoplastic of Greenhalgh in view of Scanlon to incorporate the teachings of Goiz and have it be nylon. The purpose, as stated by Goiz, being the degree of heat is sufficient to melt or fuse the sheath but not core ([0058]).
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh (US-20100094404) in view of Wangenheim (US-20100183836) and Scanlon (US-20070207186).
Regarding claim 21, Greenhalgh teaches:
A method of fabricating a docking device ([0013] and [0114]; Figs. 1 and 8, #10), the method comprising:
forming a three-dimensional (3D) woven textile structure ([0009] – [0012], [0039], [0080], [0084] – [0104], [0108], [0112], and [0135] – [0136]; Fig. 7) comprising:
positioning the 3D woven textile structure on a shape-setting mold ([0078] and [0123]; Fig. 1, #20);
heating the 3D woven textile structure to a temperature ([0078] and [0123]; Fig. 1, #20); and
removing the 3D woven textile structure from the shape-setting mold to form a shape-set docking device ([0107]; Fig. 1, #10 and #20).
Greenhalgh does not explicitly teach:
a first fiber type comprising a thermoplastic material having a first melting point,
a second fiber type having a second melting point greater than the first melting point, and
a third fiber type providing structural reinforcement of the 3D woven textile structure;
heating the 3D woven textile structure to a temperature above the first melting point and below the second melting point, such that the thermoplastic material at least partially melts and bonds portions of the 3D woven textile structure together while the second fiber type remains unmelted; and
maintaining the 3D woven textile structure on the shape-setting mold while the thermoplastic material cools to set a predetermined three-dimensional shape.
However, Wangenheim, in a similar field of endeavor, a method of weaving a 3D textile structure comprising a plurality of different types of fibers, teaches:
a first fiber type comprising a thermoplastic material having a first melting point ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20),
a second fiber type having a second melting point greater than the first melting point ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20), and
a third fiber type providing structural reinforcement of the 3D woven textile structure ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20); and
heating the 3D woven textile structure to a temperature above the first melting point and below the second melting point, such that the thermoplastic material at least partially melts and bonds portions of the 3D woven textile structure together while the second fiber type remains unmelted ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Greenhalgh to incorporate the teachings of Wangenheim and include specific fibers as well as a heating step. The purpose, as stated by Wangenheim, being in order to increase the load bearing capacity of the composite fabric product ([0061]).
Greenhalgh in view of Wangenheim does not teach:
maintaining the 3D woven textile structure on the shape-setting mold while the thermoplastic material cools to set a predetermined three-dimensional shape.
However, Scanlon, in a similar field of endeavor, a method of fabricating a stent device, teaches:
maintaining the 3D woven textile structure on the shape-setting mold while the thermoplastic material cools to set a predetermined three-dimensional shape ([0322], [0356], [0373] – [0375], and [0379]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Greenhalgh in view of Wangenheim to incorporate the teachings of Scanlon and include a cooling step. The purpose, as stated by Scanlon, being to bind the fibers ([0386]).
Regarding claim 22, Greenhalgh in view of Wangenheim and Scanlon teaches the limitations of claim 21, which claim 22 depends on, but does not explicitly teach containing certain types of fibers. However, Wangenheim further teaches:
wherein forming the 3D woven textile structure comprises weaving warp fibers ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20), weft fibers ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20), and through-the-thickness fibers to form a multilayer textile structure ([0042] – [0044] and [0061] – [0062]; Fig. 3, #20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the textile structure of Greenhalgh in view of Wangenheim and Scanlon to further incorporate the teachings of Wangenheim and include specific types of fibers. The purpose, as stated by Wangenheim, being to improve the strength of the hardened layer and the physical properties of the final product ([0062]).
Regarding claim 23, Greenhalgh in view of Wangenheim and Scanlon teaches the limitations of claim 21, which claim 23 depends on. Greenhalgh further teaches:
wherein the thermoplastic material comprises a low-melt polymer configured to function as a binder that secures adjacent yarn layers together when heated ([0078] and [0123]; Fig. 1, #20).
Regarding claim 24, Greenhalgh in view of Wangenheim and Scanlon teaches the limitations of claim 21, which claim 24 depends on. Greenhalgh further teaches:
wherein the 3D woven textile structure is formed to have a selected thickness by varying a number of woven layers prior to heating on the shape-setting mold ([0133]).
Regarding claim 25, Greenhalgh in view of Wangenheim and Scanlon teaches the limitations of claim 21, which claim 25 depends on. Scanlon further teaches:
further comprising attaching a compressible filler structure to an outer surface of the shape-set textile structure after removing the 3D woven textile structure from the shape-setting mold ([0237]).
Regarding claim 26, Greenhalgh in view of Wangenheim and Scanlon teaches the limitations of claim 21, which claim 26 depends on. Greenhalgh further teaches:
wherein positioning the 3D woven textile structure on the shape-setting mold comprises wrapping the textile structure around a cylindrical mandrel to form a hollow cylindrical docking device during heating ([0080] , [0094], [0104] – [0119]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrien J Bernard whose telephone number is (571)272-1384. The examiner can normally be reached M-R, from 7:30a.m.-4:30p.m..
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/A.B./Examiner, Art Unit 1741 /JACOB T MINSKEY/Primary Examiner, Art Unit 1748
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