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 .
Response to Arguments
Applicant's arguments filed 07/20/2026 have been fully considered but they are not persuasive.
With respect to the arguments pertaining to Lau, Examiner states that Lau teaches two wire elements in parts 124 and 104, where the angle of the bending of said wire elements constitutes multiple bending points on each part 124 and 104, wherein said bending points can be differentiated as a first and second bending point on each element. Examiner states that parts 124 and 104 constitute two braid wires. In figures 2-3, the bending of parts 124 and 104 are shown as bending in alternating directions, where each direction can be defined as upward and downward.
With respect to the bonding of mesh layers without structural deformation, said lack of structural deformation is not explicitly claimed in the claim set dated 07/20/2026. While a lack of structural deformation is not disclosed in Lau, said limitation is not required to be taught by Lau.
Specification
The amendment filed 07/20/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: on page 5 of 11 of the specification, an amendment adding in “the first bending point a further includes a tail second bending point (12A') of the first braid wires I at the first braided ring.” While a tale is present in the specification, a “tail second bending point” was not previously disclosed.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 3 and 15 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. Claims 3 and 15 are rejected for claiming a tail second bending point. While the specification dated 10/18/2023 does disclose a tail end, it does not disclose a “tail second bending point.” From here, examiner does recognize that new amendments to the specification dated 07/20/2026 does disclose a tail second bending point, but said amendment is new matter, as per the specification objection provided.
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.
Claim(s) 1-8 and 13-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lau (US Pub 2002/0040236).
Regarding claim 1, Lau (US Pub 2002/0040236) discloses a Z-shaped braided stent for being implanted into a human organ (a stent is disclosed in the abstract, Z shaped parts in figures 1B, 1D, and 1E), characterized in that the Z-shaped braided stent is a tubular stent (Z shaped parts in figures 1B, 1D, and 1E) with N braided rings (shown in figures 2-3, where the arrangement between 124 and 104 is braided. Braided in [0121]), comprising: a first tubular wire mesh (wire mesh in [0034], with a zig-zag wire in [0040]. The Torsion members in [0078] are also equivalent to wires) with the N braided rings formed by continuously braiding first braid wires in a Z shape (Z shaped parts in figures 1B, 1D, and 1E, with Z shaped parts also shown in figures 2-3),; and a second tubular wire mesh with N braided rings formed by continuously braiding second braid wires in a Z shape (As per figures 17A and 18A, two sets of Z-Shaped braids are present as parallel parts of 302 and 310 are present in the stent device),
A plurality of first bending points (11A) and second bending points (12A) of the first braid wires (first bending points being the top bends the Z shaped parts in figures 1B, 1D, and 1E, which will be on the second tubular wire of figures 17A-18A), which form by bending the first braid wires and distributed at intervals on each of a second to a (N-1)th braided rings among the N braided rings (bending of wires 124 in figure 3, weaving of wire 124 in [0136]), wherein a bending direction of the second bending points (12A) of the first braid wires is different from that of the first bending points (11A) of the first braid wires (shown in figure 2 and 3 where the direction of parts 124 and 104 change); and a plurality of first bending points (11B) and second bending points (12B) of the second braid wires (being the bend points of 124 about 104, and the bends of 104), which are formed by bending the second braid wires and distributed at intervals on each of the second to the a (N-1)th braided rings (braiding at intervals shown in figures 2-3), wherein a bending direction of the second bending points (12B) of the second braid wires is different from that of the first bending points (11B) of the second braid wires (in figures 2 and 3, where the bend of the wires are away from each other); wherein, on each of the second to the (N-1)th braided rings, the first bending points (11B) of the second braid wires hooks the second bending points (12A) of the first braid wire and the second bending points (12B) of the second braid wire hooks the first bending points (11A) of the first braid wire so as to (first bending points being the top bends the Z shaped parts in figures 1B, 1D, and 1E, which will be on the second tubular wire of figures 17A-18A) (the second tubular wire mesh and the first tubular wire mesh are connected together to form the Z-Shape braded stent (connecting of wires in figures 2-3 form a Z shape);
Regarding claim 2, Lau discloses the Z-shaped braided stent of claim 1, characterized in that In that the first bending point (11A) of the first braided wire and the first bending point (11B) of the second braided wire are downward bending points; the second bending point (12A) of the first braided wire and the second bending point (12B) of the second braided wire are upward bending points (as parts 124 and 104 bend in separate ways in figures 2 and 3, one direction of bending can be defined as bending downward and the other bending can be defined as an upward bending).
Regarding claim 3, Lau discloses the Z-shaped braided stent of claim 1, characterized in that after the first braid wires jump from a tail (the ends of the stent 122 in figure 2 and 140 in figure 5 have a tail) second bending point (12A’) of the first wires (being of the stent wire in figure 5, being the end of the wires of figures 1A-1E) at an ith braided ring to an (i+2)th braided ring to start continuous braiding in a Z shape (continuous braiding in a Z shape shown in figures 2-3 with part 104), the plurality of first bending points (11A) and second bending points (12A) of the first wires are formed on the (i+2)th braided ring and the (i+1)th braided ring (being the bending points at 104 and 124 in figure 3, where (i+1) and (i+2) represent different sections of the braid shown in figures 2 and 3); after the second braid wires jump from a tail second bending point (12B’) the ith braided ring to the (i+2)th braided ring to start continuous braiding in a Z shape (continuous braiding in a Z shape in figure 3, where said braiding starts at the tail end of the wire that part 104 connects to in figure 2 and continues to form a Z shape in figures 2-3), the plurality of second bending points (11B) and second bending points (12B) of the second wires are formed on the (i+2)th braided ring and the (i+1)th braided ring (being the bending points about part 124 in figures 2-3); Wherein i = 1, 2 N (being the bending of parts 124 that occur below the topmost part 124 in figure 3).
Regarding claim 4, Lau discloses the Z-shaped braided stent of claim 1, characterized in that the first braided ring and the second braided ring and the (N-1)th and Nth braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a circumferential direction parallel to the tubular stent (parts 104 and 124, shown in figures 2-3, extend in a circumferential direction parallel to the tubular stent portion shown in figure 5), and the third to (N-2)th braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a helical manner at a helical angle α (braiding at an angle is shown in figure 3, where a braiding of rings to a tubular mesh is present in figure 3).
Regarding claim 5, Lau discloses the Z-shaped braided stent of claim 4, characterized in that the helical angle α is 10°-50° (a helical angle in Lau is considered to be the angle of displacement between the struts as it wraps around the tubular body. This angle was measured to be between 30 and 40 degrees in figure 3).
Regarding claim 6, Lau discloses the Z-shaped braided stent of claim 1, characterized in that the first bending point and the second bending point have a bending angle ß of 30°-60° (the bend angle of Lau, being the angle about the apex of parts 104 in figure 3, was measured to be just below 60 degrees).
Regarding claim 7, Lau discloses the 7 Z-shaped braided stent of claim any one of claims 1, characterized in that the first braided ring and the second braided ring and the (N-1)th and Nth braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a circumferential direction parallel to the tubular stent (in figures 3 and 5, the braided rings extend parallel to the direction of the tubular stent in figure 5), and the third to (N-2)th braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a helical manner at a helical angle α (being the angle between the wire members of the mesh in figures 2-3); the helical spacing S between first braid wires and second braid wires from the third braided ring to the Nᵗʰ braided ring of the first tubular wire mesh and the second tubular wire mesh is 0.2-10 mm (as the stent can range from between 2.0mm and 30 mm in [0083], it stands to reason that the distance between the first and second wire can range between 0.2 mm-10mm as 15 sets of wire part 142 are shown in figure 5).
Regarding claim 8, Lau discloses the 8 the Z-shaped braided stent of claim 1 any one of claims 1, characterized in that the first braid wires and/or second braid wires are composed of the same material or different materials, in particular comprising: combinations of metal wire + metal wire, metal wire + non-metallic wire, non-metallic wire + non-metallic wire (plurality of materials disclosed in [0078] and [0109]); wherein, the metal wires are selected from materials such as stainless steel, cobalt-chromium alloy, nickel-titanium alloy, and degradable zinc/magnesium alloy wires, and the non-metallic wires are selected from materials such as degradable polylactic acid wires (cobalt chrome alloys in [0109]. Nonmetalic materials in [0114]-[0116]).
Regarding claim 13, Lau (US Pub 2002/0040236) discloses an implementation method for a Z-shaped braided stent for implanting into a human organ (a stent for a treatment of a human is disclosed in the abstract, Z shaped parts in figures 1B, 1D, and 1E), the Z-shaped braided stent being a tubular stent (Z shaped parts in figures 1B, 1D, and 1E, tubular stent shown in figures 3-5) with N braided rings, characterized in that the method comprises: forming a first tubular wire mesh (wire mesh in [0034], with a zig-zag wire in [0040]. The Torsion members in [0078] are also equivalent to wires) with the N braided rings by continuously braiding first braid wires in a Z shape (Z shaped parts in figures 1B, 1D, and 1E, with Z shaped parts also shown in figures 2-3),; after forming a first tubular wire mesh with N braided rings, forming a second tubular wire mesh having N braided rings by continuously braiding second braid wires in a Z shape (As per figures 17A and 18A, two sets of Z-Shaped braids are present as parallel parts of 302 and 310 are present in the stent device), on each of a second to a (N-1)th braided rings among the N braided rings (braiding of wires 124 in figure 3, weaving of wire 124 in [0136]), forming the plurality of first bending points (11A) and second bending points (12A) of the first braid wires distributed at intervals by bending the first braid wires (being the bending along different points of wire 104), wherein a bending direction of the second bending points (12A) of the first braid wires is different from that of the first bending points (11A) of the first braid wires (as parts 104 are bending in alternating directions in figure 3, a different direction between first and second bending points is present); and on each of the second to the (N-1)th braided rings, forming the plurality of first bending points (12A) and second bending points (12B) of the second braid wires distributed at intervals by bending the second braid wires (shown in figure 3, where each row of bends 104 constitute a different value for N of the braided rings), wherein a bending direction of the second bending points (12B) of the second braid wires is different from that of the first bending points (11B) of the second braid wires (the bends at part 104 along different rows in figure 3 can be defined such that a 11B and 12B bend are in different directions); wherein, on each of the second to the (N-1)th braided rings, the first bending points (11B) of the second braid wires hooks the second bending points (12A) of the first braid wires and the second bending points (12B) of the second braid wires hooks the first bending points (11A) (being the interface between bends part 104 and the bends of wire part 124 shown in figures 2 and 3) of the first braid wires so as to, the second tubular wire mesh and the first tubular wire mesh are connected to form the Z-shape braided stent (in figures 2-3, where the second Z-Shaped wire is braided into a continuous mesh via parts 124 along with the first Z-Shaped wire, thereby creating a second mesh between other Z-Shaped elements also pictured in figures 2-3).
Regarding claim 14, Lau discloses the method of claim 13, characterized in that the first bending point (11A) of the first braided wire and the first bending point (11B) of the second braided wire are downward bending points; the second bending point (12A) of the first braided wire and the second bending point (12B) of the second braided wire are upward bending points.
Regarding claim 15, Lau discloses the method of claim 13, characterized in that after the first braid wires jump from a tail (the ends of the stent 122 in figure 2 and 140 in figure 5 have a tail) second bending point (12A’) of the first wires (being of the stent wire in figure 5, being the end of the wires of figures 1A-1E) at an braided ring to an (i+2)th braided ring to start continuous braiding in a Z shape (continuous braiding in a Z shape shown in figures 2-3 with part 104), the plurality of first bending points (11A) and the second bending points (12A) of the first wires are formed on the (i+2)th braided ring and an (i+1)th braided ring (being the bending points at 104 and 124 in figure 3, where (i+1) and (i+2) represent different sections of the braid shown in figures 2 and 3) after the second braid wires jump from a tail second bending point (12B’) at ith braided ring of to the (i+2)th braided ring to start continuous braiding in a Z shape (continuous braiding in a Z shape in figure 3, where said braiding starts at the tail end of the wire that part 104 connects to in figure 2 and continues to form a Z shape in figures 2-3), the plurality of second bending points (11B) and the second bending points (12B) of the second wires are formed on the (i+2)th braided ring the (i+1)th braided ring (being the bending points about part 124 in figures 2-3) wherein i = 1, 2 N (being the bending of parts 124 that occur below the topmost part 124 in figure 3).
Regarding claim 16, Lau discloses the method of claim 13, characterized in that the first braided ring and the second braided ring, and the (N-1)th braided ring and Nᵗʰ braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a circumferential direction parallel to the tubular stent (parts 104 and 124, shown in figures 2-3, extend in a circumferential direction parallel to the tubular stent portion shown in figure 5), and the third to (N-2)th braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a helical manner at a helical angle α (braiding at an angle is shown in figure 3, where a braiding of rings to a tubular mesh is present in figure 3).
Regarding claim 17, Lau discloses the method of claim 16, characterized in that the helical angle α is 10°-50° (a helical angle in Lau is considered to be the angle of displacement between the struts as it wraps around the tubular body. This angle was measured to be between 30 and 40 degrees in figure 3).
Regarding claim 18, Lau discloses the method of claim 13-or 14, characterized in that the first bending point and the second bending point have a bending angle ß of 30°-60° (the bend angle of Lau, being the angle about the apex of parts 104 in figure 3, was measured to be just below 60 degrees).
Regarding claim 19, Lau discloses the method of claim 13-or 14, characterized in that the first and second braided rings and the (N-1)th and Nth braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a circumferential direction parallel to the tubular stent (in figures 3 and 5, the braided rings extend parallel to the direction of the tubular stent in figure 5), and the third to (N-2)th braided rings of the first tubular wire mesh and the second tubular wire mesh extend in a helical manner at a helical angle α (being the angle between the wire members of the mesh in figures 2-3); the helical spacing S between first braid wires and second braid wires from the third braided ring to the Nᵗʰ braided ring of the first tubular wire mesh and the second tubular wire mesh is 0.2-10 mm (as the stent can range from between 2.0mm and 30 mm in [0083], it stands to reason that the distance between the first and second wire can range between 0.2 mm-10mm as 15 sets of wire part 142 are shown in figure 5).
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(s) 9-12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lau (US Pub 2002/0040236) in view of Baldwin (US Patent No.: 9,364,351).
Regarding claim 9, Lau discloses the Z-shaped braided stent of claim 1. However, Lau does not teach an instance characterized by further comprising a traction device connecting the Nth braided ring of the first tubular wire mesh and the Nᵗʰ braided ring of the second tubular wire mesh, the traction device comprising: a traction wire braided mesh having one end connected to the Nth braided ring of the first tubular wire mesh and the Nᵗʰ braided ring of the second tubular wire mesh; a connecting end connected to the other end of the traction wire braided mesh.
Instead, Baldwin (US Patent No.: 9,364,351) teaches further comprises a traction device connecting the Nth braided ring of the first tubular wire mesh and the Nᵗʰ braided ring of the second tubular wire mesh (being connection part 27 in figure 6, disclosed in column 3 lines 39-56), the traction device comprising: a traction wire braided mesh having one end connected to the Nth braided ring of the first tubular wire mesh and the Nᵗʰ braided ring of the second tubular wire mesh (shown in figure 6, where different ends of a mesh component are connected via part 27); a connecting end connected to the other end of the traction wire braided mesh (shown in figure 6, where the ends are the ends of part 27 that are connected to wire 15). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a means to attach the struts of a stent as presented in Baldwin into Lau for the purpose of providing a means to connect the struts to form a stent (as per the abstract) via a welding (in column 3 lines 39-56) with a laser (in column 3 lines 57-67 into column 4 lines 1-6) which allows for a smoothing of a stent (smoothing in the abstract and column 4 lines 7-23) that prevents the stent from possibly damaging a lumen after implantation.
Regarding claim 10, Lau in view of Baldwin teach the Z-shaped braided stent of any one of claim 9, where Baldwin is characterized in that the traction wire braided mesh is braided from a plurality of traction wires or is formed by laser etching a metal tube (laser along part 64 to create a traction element of Baldwin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a means to attach the struts of a stent as presented in Baldwin into Lau for the purpose of providing a means to connect the struts to form a stent (as per the abstract) via a welding (in column 3 lines 39-56) with a laser (in column 3 lines 57-67 into column 4 lines 1-6) which allows for a smoothing of a stent (smoothing in the abstract and column 4 lines 7-23) that prevents the stent from possibly damaging a lumen after implantation.
Regarding claim 11, Lau in view of Baldwin teach the Z-shaped braided stent of any one of claim 10, characterized in that the connecting ends are offset from the axis of the tubular stent (as per figure 5-6, the connecting ends at part 27 are offset from a tubular axis, as per figure 5, as the axis formed by the apexes of part 15 does not extend parallel to the axis of the tube part 30). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a means to attach the struts of a stent as presented in Baldwin into Lau for the purpose of providing a means to connect the struts to form a stent (as per the abstract) via a welding (in column 3 lines 39-56) with a laser (in column 3 lines 57-67 into column 4 lines 1-6) which allows for a smoothing of a stent (smoothing in the abstract and column 4 lines 7-23) that prevents the stent from possibly damaging a lumen after implantation.
Regarding claim 12, Lau in view of Baldwin teach the Z-shaped braided stent of any one of claim 10, with Baldwin characterizing in that the connecting ends are hook-shaped or tubular (shown in figure 6, where the ends of struts part 18 are depicted as being hooked shaped). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a means to attach the struts of a stent as presented in Baldwin into Lau for the purpose of providing a means to connect the struts to form a stent (as per the abstract) via a welding (in column 3 lines 39-56) with a laser (in column 3 lines 57-67 into column 4 lines 1-6) which allows for a smoothing of a stent (smoothing in the abstract and column 4 lines 7-23) that prevents the stent from possibly damaging a lumen after implantation.
Regarding claim 20, Lau teaches the method of claim 13 any one of claims 13. However, Lau does not teach a characterized in that a traction device connecting the Nth braided ring of the first tubular wire mesh and the Nth braided ring of the second tubular wire mesh, the traction device comprises: a traction wire braided mesh having one end connected to the Nᵗʰ braided ring of the first tubular wire mesh and the Nth braided ring of the second tubular wire mesh; a connecting end connected to the other end of the traction wire braided mesh.
Instead, Baldwin (US Patent No.: 9,364,351) teaches a further comprising of a method characterized in that a traction device connecting the Nth braided ring of the first tubular wire mesh and the Nth braided ring of the second tubular wire mesh (being connection part 27 in figure 6, disclosed in column 3 lines 39-56), the traction device comprises: a traction wire braided mesh having one end connected to the Nᵗʰ braided ring of the first tubular wire mesh (shown in figure 6, where different ends of a mesh component are connected via part 27); and the Nth braided ring of the second tubular wire mesh (shown in figure 6, where different ends of a mesh component are connected via part 27); a connecting end connected to the other end of the traction wire braided mesh (shown in figure 6, where the ends are the ends of part 27 that are connected to wire 15). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a means to attach the struts of a stent as presented in Baldwin into Lau for the purpose of providing a means to connect the struts to form a stent (as per the abstract) via a welding (in column 3 lines 39-56) with a laser (in column 3 lines 57-67 into column 4 lines 1-6) which allows for a smoothing of a stent (smoothing in the abstract and column 4 lines 7-23) that prevents the stent from possibly damaging a lumen after implantation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kim (US Patent No.: 6,270,524) considered for a stent device with attachment means part 22 in figure 2C between struts. Macatangay (US Pub No.: 2010/0198333) discloses a stent with an offset struts at an angle 110 in figure 3.
THIS ACTION IS MADE FINAL. 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.
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
