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
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claim(s) 1-3, 5-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shaolian (US6197049B1) in view of Itoi (20210259861).
Regarding claim 1, Shaolian discloses a stent (FIG 19; 107) comprising: a main body (FIG 19, Section A of #108) formed in a hollow tube shape (FIG 19); and a first bifurcation (FIG 19, Section B of #108) and a second bifurcation (FIG 19, #109) which are extend from an end of the main body in the longitudinal direction of the main body (FIG 17), wherein the stent comprises an artificial blood vessel (106) consisting of a main blood vessel (FIG 17; portion of #106 that corresponds to Section A of 108), and a first branch blood vessel (FIG 17; portion of #106 that corresponds to Section B of 108) and a second branch blood vessel (FIG 17; iliac branch portion of 106 that corresponds to second bifurcation 109) branched from the main blood vessel, wherein the main body is arranged to surround the main blood vessel (Fig. 17 and column 15, line 62 – column 16, line 6 which discloses 106 may be situated concentrically inside 107 ), the first bifurcation is arranged to surround a portion of the first branch blood vessel (FIG 17 and column 15, line 62 – column 16, line 6 which discloses 106 may be situated concentrically inside 107), and the second bifurcation is arranged to surround a portion of the second branch blood vessel (Fig. 17 and column 15, line 62 – column 16, line 6 which discloses 106 may be situated concentrically inside 107), wherein the stent (107) includes a plurality of cells which are formed by weaving one wire in zigzags (Figs. 17-20), wherein each of the cells includes an end cell formed at the end of the main body (FIG 19), but Shaolian fails to disclose that the first bifurcation (FIG 17, #108) and the second bifurcation (FIG 17, #109) are formed as one wire integrally with the main body at the lower end of the end cell.
Itoi also discloses the first bifurcation (2B) and the second bifurcation (2C) and teaches that they are formed as one wire integrally with the main body (2A) at the lower end of the end cell ([0067]). Therefore, 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 Shaolian to include that the first bifurcation and the second bifurcation are formed as one wire integrally with the main body at the lower end of the end cell, as taught by Itoi, in order to enable easier production of the bile duct stent ([0067]).
Regarding claim 2, Shaolian as modified by Itoi discloses the invention of claim 1, as well as that the second bifurcation (FIG 17, #109) is spaced apart (FIG 17) from the first branch bifurcation (FIG 17, #108). That the first bifurcation (FIG 17, #108) is formed by weaving additional cells with a continuous portion of the end cell of the main body in the longitudinal direction of the main body (Col 16, line 8: “Tubular wire support 107 comprises a primary component 108 for traversing the aorta and a first iliac”) and that the second bifurcation (FIG 17, #109) is formed by weaving additional cells with another continuous portion of the end cell of the main body (FIG 17, #108) in the longitudinal direction of the main body (Col 16, line 9: “A branch component 109 for extending into the second iliac”).
That the first bifurcation is formed by weaving additional cells with a continuous portion of the end cell of the main body in the longitudinal direction of the main body and that the second bifurcation is formed by weaving additional cells with another continuous portion of the end cell of the main body in the longitudinal direction of the main body is also product by process and thereby not given patentable weight.
Regarding claim 3, Shaolian as modified by Itoi discloses the invention of claim 1, as well as that the stent (FIG 17) comprises a first reinforcing structure (102) comprising a plurality of grid patterns (see following image), each grid pattern comprises the end cell (see following image) and a cell of the first bifurcation (see following image) or the end cell (see following image) and a cell of the second bifurcation (see following image).
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Regarding claim 5, Shaolian discloses a stent (FIG 19; 107) comprising: a main body (FIG 19, Section A of #108) formed in a hollow tube shape (FIG 19); and a first bifurcation (FIG 19, Section B of #108) and a second bifurcation (FIG 19, #109) which are formed by extending from an end of the main body in the longitudinal direction of the main body (FIG 17), wherein the stent comprises an artificial blood vessel (106) consisting of a main blood vessel (FIG 17; portion of #106 that corresponds to Section A of 108), and a first branch blood vessel (FIG 17; portion of #106 that corresponds to Section B of 108) and a second branch blood vessel (FIG 17; iliac branch portion of 106 that corresponds to second bifurcation 109) branched from the main blood vessel, wherein the main body is arranged to surround the main blood vessel (Fig. 17 and column 15, line 62 – column 16, line 6 which discloses 106 may be situated concentrically inside 107 ), the first bifurcation is arranged to surround a portion of the first branch blood vessel (FIG 17 and column 15, line 62 – column 16, line 6 which discloses 106 may be situated concentrically inside 107), and the second bifurcation is arranged to surround a portion of the second branch blood vessel (Fig. 17 and column 15, line 62 – column 16, line 6 which discloses 106 may be situated concentrically inside 107), wherein the stent (107) includes a plurality of cells which are formed by weaving one wire in zigzags (Figs. 17-20), wherein each of the cells includes an end cell formed at the end of the main body (FIG 19). As Shaolian discloses the structure of this stent, there must also be a generic method of forming this structure. Shaolian fails to disclose that the method comprises step (a) of forming the first bifurcation as one wire integrally with the main body; and step (b) of forming the second bifurcation as one wire integrally with the main body.
Itoi discloses the first bifurcation (2B) and the second bifurcation (2C) and teaches that they are formed as one wire integrally with the main body (2A) at the lower end of the end cell ([0067]). As Itoi teaches this structure, there must be a method of forming this structure. Therefore, 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 Shaolian to include step (a) of forming the first bifurcation as one wire integrally with the main body; and step (b) of forming the second bifurcation as one wire integrally with the main body, as taught by Itoi, in order to enable easier production of the bile duct stent ([0067]).
Regarding claim 6, Shaolian as modified by Itoi discloses the method of claim 5, wherein in step (a), forming the first bifurcation (FIG 17, #108) by weaving additional cells with a continuous portion of the end cell of the main body in the longitudinal direction of the main body (Col 16, line 8: “Tubular wire support 107 comprises a primary component 108 for traversing the aorta and a first iliac”), and wherein in step (b), forming the second bifurcation (FIG 17, #109) spaced apart (FIG 17) from the first bifurcation (FIG 17, #108). As Shaolian discloses the structure of this stent, there must also be a generic method of forming this structure. Shaolian fails to disclose that step (b) includes and by weaving additional cells with another continuous portion of the end cell of the main body in the longitudinal direction of the main body.
Itoi also discloses the first bifurcation (2B) and the second bifurcation (2C) and teaches that they are formed by weaving additional cells with another continuous portion of the end cell of the main body in the longitudinal direction of the main body ([0067]). As Itoi teaches this structure, there must be a method of forming this structure. Therefore, 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 Shaolian to include the method of step (b), forming the second bifurcation spaced apart from the first bifurcation and by weaving additional cells with another continuous portion of the end cell of the main body in the longitudinal direction of the main body, as taught by Itoi, in order to enable easier production of the bile duct stent ([0067]).
Regarding claim 7, Shaolian as modified by Itoi discloses the method of claim 5, wherein the method further comprises step (c) of forming a first reinforcing structure (102) comprising a plurality of grid patterns (see following image), and wherein each grid pattern comprises the end cell (see following image) and a cell of the first bifurcation (see following image) or the end cell (see following image) and a cell of the second bifurcation (see following image). As Shaolian discloses the structure of this stent, there must also be a generic method of forming this structure.
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Regarding claim 9, Shaolian as modified by Itoi discloses the invention of claim 2 as well as that the stent (FIG 17) comprises a first reinforcing structure (102) comprising a plurality of grid patterns (see following image), each grid pattern comprises the end cell (see following image) and a cell of the first bifurcation (see following image) or the end cell (see following image) and a cell of the second bifurcation (see following image).
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Regarding claim 10, Shoalian as modified by Itoi discloses the method of claim 6, wherein the method further comprises step (c) of forming a first reinforcing structure (102) comprising a plurality of grid patterns (see following image), and wherein each grid pattern comprises the end cell (see following image) and a cell of the first bifurcation (see following image) or the end cell (see following image) and a cell of the second bifurcation (see following image). As Shaolian discloses the structure of this stent, there must also be a generic method of forming this structure.
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Claim(s) 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Shaolian (US6197049B1) in view of Itoi (20210259861), as applied to claims 3 and 8, and further in view of Lau (5876432).
Regarding claim 4, Shaolian as modified by Itoi discloses the invention of claim 2, but fails to disclose that the stent comprises a zigzag-shaped second reinforcing structure, wherein the second reinforcing structure successively passes through the first to fourth vertices and wherein the first vertex is in the main body, the second vertex is in the first bifurcation, the third vertex is in the main body, and the fourth vertex is in the second bifurcation.
Lau discloses another expandable stent and teaches the concept of a second reinforcing structure for maintaining a phased relationship of the stent cells (flexible linkage 124 in FIG 3; column 11, line 60 – column 12, line 5), wherein the second reinforcing structure successively passes through the first to fourth vertices and wherein the first vertex is in the main body, the second vertex is in the first bifurcation, the third vertex is in the main body, and the fourth vertex is in the second bifurcation. As this reinforcing structure is taught by Lau, it would be obvious to pass the reinforcement around any of the vertices of the Shaolian stent to obtain the desired support and mechanical properties.
Therefore, 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 Shaolian to include that the stent comprises a zigzag-shaped second reinforcing structure, wherein the second reinforcing structure successively passes through the first to fourth vertices and wherein the first vertex is in the main body, the second vertex is in the first bifurcation, the third vertex is in the main body, and the fourth vertex is in the second bifurcation, as taught by Lau, as the modification merely involves a combination of known stent structures according to known methods that obtains a predictable result of maintaining a desired spatial relationship between cells and apices of a stent structure.
Regarding claim 8, Shaolian as modified by Itoi and as further modified by Lau discloses the method of claim 5, but fails to disclose step (d) of forming a zigzag-shaped second reinforcing structure, wherein the second reinforcing structure successively passes through the first to fourth vertices and wherein the first vertex is in the main body, the second vertex is in the first bifurcation, the third vertex is in the main body, and the fourth vertex is in the second bifurcation.
Lau discloses another expandable stent and teaches the concept of a second reinforcing structure for maintaining a relationship of the stent vertices (flexible linkage 124 in FIG 3; column 11, line 60 – column 12, line 5), wherein the second reinforcing structure successively passes through the first to fourth vertices and wherein the first vertex is in the main body, the second vertex is in the first bifurcation, the third vertex is in the main body, and the fourth vertex is in the second bifurcation. As this reinforcing structure is taught by Lau, it would be obvious to pass the reinforcement around any of the vertices of modified Shaolian to obtain the desired support and mechanical properties. Since Shaolian, Itoi and Lau disclose the structure of this stent, there must also be a generic method of forming this structure.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shaolian to include step (d) of forming a zigzag-shaped second reinforcing structure, wherein the second reinforcing structure successively passes through the first to fourth vertices and wherein the first vertex is in the main body, the second vertex is in the first bifurcation, the third vertex is in the main body, and the fourth vertex is in the second bifurcation, as taught by Lau, as the modification merely involves a combination of known stent structures according to known methods that obtains a predictable result of maintaining a desired spatial relationship between cells and apices of a stent structure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774