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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/24/2026 has been entered.
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.
Claims 1-2, 5-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. (JP2012055469A) in view of Hiroshige et al. (US 20140214006 A1).
Regarding claim 1, Tsueta discloses a catheter (catheter 49, Fig 5) comprising: a shaft (shaft 42, Fig 5) including a distal end (distal side Ts, Fig 5) and a proximal end (terminal side Es, Fig 5); the shaft (42) including an inner layer (inner layer 31, Fig 5), an outer layer (outer layer 33, Fig 5), and a braid (metal braid reinforcing layer 32, [0038, Fig 5]) that is disposed between the inner layer (31) and the outer layer (33), the braid (32) including a plurality of metal wires that are woven together such that the woven wires forming the braid intersect each other at intersection points (metal braid is formed of metal wires woven together in a certain pattern ; [0038], not explicit); the braid (32) including a welding portion (portion of braid welded at intersection points between braid wires and marker stopper 11; [0062], Fig 5) in a vicinity of a distal end (distal end 1001 of braid 32, along Ts Fig 5) of the braid (32), the welding portion (welding portion 1000 between 11 and corresponding section of 32, Annotated Fig 1) being located proximal of the distal end (Ts) of the shaft (42), the welding portion (1000, Annotated Fig 1) of the braid (32) having a proximal-most end (1002, Annotated Fig 1) and a distal-most end (1003, Annotated Fig 1); and the shaft (42) including a radiopaque marker (radiopaque marker 21, Fig 5) having a distal-most end (1004, Annotated Fig 1-2), the proximal- most end (1002, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) being closer to the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21) than the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1), an entirety of the welding portion (1000, Annotated Fig 1) being located on a distal side of the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21) so that a space (1005, Annotated Fig 1) exists between the proximal-most end (1002, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) and the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21) and an imaginary continuation (1016, Annotated Fig 1) of the inner surface of the radiopaque marker (inner surface of radiopaque marker 21, Fig 5) in the distal direction being positioned radially outwardly of and spaced radially outwardly (Annotated Fig 1) ) from the braid (32) and the welding portion (1000, Annotated Fig 1).
Tsueta does not explicitly discloses the woven wires being welded together at the intersection points in the welding portion.
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Hiroshige teaches a catheter (Fig 1) comprising woven wires (woven wires 26a and 26b, Fig 4A) being welded together at the intersection points (intersections 30, Fig 4A-4C ) in the welding portion ([0036]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the welding portion of device of Tsueta to incorporate welding at the intersection points of the woven wires and a similar bulging portion at the cut off distal end portion as taught by Hiroshige for the purpose of reducing the risk that the wires will spread apart and increase their welding strength ([0007;[0036]; [0045])
Regarding claim 2, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the radiopaque marker (21) has a length (L1, Annotated Fig 2) in an axial direction of the shaft (42), and the length (L1, Annotated Fig 2) of the radiopaque marker (21) in the axial direction being greater than a distance (L2, Annotated Fig 2) from the distal- most end (1003, Annotated Fig 1) of the welding portion to the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21).
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Regarding claim 5, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the radiopaque marker (21) is a tube made of radiopaque material (radiopaque marker 21 has a cylindrical shape, Fig 5, 6; [0041]).
Regarding claim 6, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) is positioned proximal of a distal-most end (Ts) of the shaft (42) (Annotated Fig 1).
Regarding claim 7, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the braid (32) is positioned radially between an inner surface (1006, Annotated Fig 2) of the shaft (42) and an inner surface (1007, Annotated Fig 2) of the radiopaque marker (21).
Regarding claim 8, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the radiopaque marker (21) includes a proximal-most end (free end 1008, Annotated Fig 2) that is a free end of the radiopaque marker (21), the proximal-most end (1006, Annotated Fig 2) of the radiopaque marker (21) being positioned distally of a proximal end portion (1009, Annotated Fig 2) of the braid (32) (See annotated Fig 2).
Regarding claim 10, Tsueta/Hiroshige discloses the catheter according to Claim 1.Tsueta discloses wherein the radiopaque marker (21) is tubular in configuration material (radiopaque marker 21 has a cylindrical shape, Fig 5; [0041]) and possesses a proximal-most end (1008, Annotated Fig 2) and a distal-most end (1004, Annotated Fig 2), the radiopaque marker (21) being configured and positioned so that: i) the distal-most end (1004, Annotated Fig 2) of the radiopaque marker (21) is proximal of the distal end (Ts) of the shaft (42); and ii) the braid (32) extends distally beyond the distal-most end (1004, Annotated Fig 2) of the radiopaque marker (21); and iii) the braid (32) extends proximally beyond the proximal-most end (1008, Annotated Fig 2) of the radiopaque marker (21).
Regarding claim 21, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta is silent wherein the welding portion is at a most distal end of the braid
Hiroshige teaches Hiroshige teaches a catheter (Fig 1) comprising woven wires (woven wires 26a and 26b, Fig 4A) being welded together at the intersection points (intersections 30, Fig 4A-4C) in the welding portion ([0036]) wherein the welding portion is at a most distal end of the braid (26a-b) (Fig 4B-C; [0036]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the welding portion of device of Tsueta/Hiroshige to incorporate welding at the intersection points of the woven wires and a similar bulging portion at the cut off distal end portion as taught by Hiroshige for the purpose of reducing the risk that the wires will spread apart and increase their welding strength ([0007;[0036]; [0045])
Claim 3-4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. JP2012055469A in view of Hiroshige et al. (US 20140214006 A1) in further view of Tsukumo et al. (JP2007319594A).
Regarding claim 3, Tsueta/Hiroshige discloses the catheter according to Claim 2. Tsueta discloses wherein the radiopaque marker (21) is a coil ([0092]: marker 21 is not limited to ring-shaped and could be a metal having a coiled structure). Tsueta discloses the thickness (1014, Annotated Fig 3) of the coil (21) being less than a distance (L2, Annotated Fig 3) from the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) to the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21).
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Tsueta is silent regarding the metal radiopaque marker coil being comprised of a wire that is wound in a coil, and an outer diameter of the wire being less than a distance from the distal-most end of the welding portion to the distal-most end of the radiopaque marker.
Tsukumo teaches a catheter (Fig 3) comprising a radiopaque marker (X-ray opaque metal marker 6, Fig 3) comprised of a wire that is wound in a coil and an outer diameter ([0035]: “Furthermore, the metal marker 6 having radiopacity may be formed by winding a radiopaque metal wire in a coil shape. When metal wire is used, it is preferred that the diameter be between 5 and 60 microns”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Tsueta/Hiroshige with similar coil wire marker as taught by Tsukumo for the purpose to ensure sufficient visibility and flexibility of the radiopaque markers with minimal or no increase in overall catheter diameter ([0017];[0035] (Note: the overall dimensions of radiopaque marker of Tsueta are maintained, the diameter of the coil wire would be equivalent to the thickness of radiopaque marker of Tsueta)
Regarding claim 4 Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the radiopaque marker (21) is a coil ([0092]: marker 21 is not limited to ring-shaped and could be a metal having a coiled structure). Tsueta discloses the thickness (1014, Annotated Fig 3) of the coil (21) being less than a distance (L2, Annotated Fig 3) from the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) to the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21).
Tsueta is silent regarding the metal radiopaque marker coil being comprised of a wire that is wound in a coil, and an outer diameter of the wire being less than a distance from the distal-most end of the welding portion to the distal-most end of the radiopaque marker.
Tsukumo teaches a catheter (Fig 3) comprising a radiopaque marker (X-ray opaque metal marker 6, Fig 3) comprised of a wire that is wound in a coil and an outer diameter ([0035]: “Furthermore, the metal marker 6 having radiopacity may be formed by winding a radiopaque metal wire in a coil shape. When metal wire is used, it is preferred that the diameter be between 5 and 60 microns”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Tsueta/Hiroshige with similar coil wire marker as taught by Tsukumo for the purpose to ensure sufficient visibility and flexibility of the radiopaque markers with minimal or no increase in overall catheter diameter ([0017];[0035](Note: the overall dimensions of radiopaque marker of Tsueta are maintained, the diameter of the coil wire would be equivalent to the thickness of radiopaque marker of Tsueta).
Regarding claim 11, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta wherein the shaft (42) is a tubular shaft (Fig 5, shows the tubular shape of shaft 42) and includes a central axis (1010, Annotated Fig 2), the radiopaque marker (21) including a wound coil ([0092]: marker 21 is not limited to ring-shaped and could also have a coiled structure), the radiopaque marker (21) possessing a distal-most end (1004, Annotated Fig 2) and the welding portion (1000, Annotated Fig 1) possessing a distal-most end (1003, Annotated Fig 1), the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) being positioned distally beyond the distal-most end (1004, Annotated Fig 2) of the radiopaque marker (21) by an axial distance (L2, Annotated Fig 2) parallel to the central axis (1010, Annotated Fig 2) of the shaft (42)
Tsueta discloses the thickness (1014, Annotated Fig 3) of the coil (21) being less than a distance (L2, Annotated Fig 3) from the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) to the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21).
Tsueta is silent regarding the metal radiopaque marker coil being comprised of a wire that is wound in a coil, and an outer diameter of the wire being less than an axial distance from the distal-most end of the welding portion to the distal-most end of the radiopaque marker.
Tsukumo teaches a catheter (Fig 3) comprising a radiopaque marker (X-ray opaque metal marker 6, Fig 3) comprised of a wire that is wound in a coil and an outer diameter ([0035]: “Furthermore, the metal marker 6 having radiopacity may be formed by winding a radiopaque metal wire in a coil shape. When metal wire is used, it is preferred that the diameter be between 5 and 60 microns”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Tsueta/Hiroshige with similar coil wire marker as taught by Tsukumo for the purpose to ensure sufficient visibility and flexibility of the radiopaque markers with minimal or no increase in overall catheter diameter ([0017];[0035](Note: the overall dimensions of radiopaque marker of Tsueta are maintained, the diameter of the coil wire would be equivalent to the thickness of radiopaque marker of Tsueta).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. JP2012055469A in view of Hiroshige et al. (US 20140214006 A1) in view of Tsukumo et al. (JP2007319594A) in further view of Gunderson et al. (US 20080125752 A1).
Regarding claim 23, Tsueta/Hiroshige/Tsukumo discloses the catheter according to Claim 11. Tsueta is silent wherein a radially outer facing surface of the welding portion and a most distal end of the braid face toward an outer surface of the tubular shaft, the radially outer facing surface of the welding portion and the most distal end of the braid being in contact with and covered solely by the outer layer.
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Gunderson teaches a catheter (Fig 9-11) comprising a welding portion (456a/456b/456c/456d/456e, Fig 11; [0036]) wherein a radially outer facing surface (2001, Annotated Fig 4) of the welding portion (2000, Annotated Fig 4) and a most distal end of the braid face (2002, Annotated Fig 4) toward an outer surface (2003, Annotated Fig 4) of the tubular shaft (2004, Annotated Fig 4), the radially outer facing surface (2001, Annotated Fig 4) of the welding portion (2000, Annotated Fig 4) and the most distal end of the braid (2002, Annotated Fig 4) being in contact with and covered solely by the outer layer (462, Fig 11).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the welding portion device of Tsueta/Hiroshige/Tsukumo to include a series of circumferential spot welds in the braid intersection points in contact and covered by the outer layer as taught by Gunderson for the purpose of further secure the reinforcement member wires ([0036]).
Claim 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. JP2012055469A in view of Hiroshige et al. (US 20140214006 A1) in further view of Shimada et al. (US 20190046763 A1).
Regarding claim 9, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta is silent wherein the radiopaque marker possesses an axial length of 0.5 mm to 10 mm.
Shimada teaches a catheter (catheter subassembly 600, Fig 5) comprising a radiopaque marker (radiopaque marker band 610; [0082]) possesses an axial length of 0.5 mm to 10 mm ([0082]: “The radiopaque marker 610 can comprise a length of about 0.5 mm to about 5-mm.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the length radiopaque marker of device of Tsueta/Hiroshige with a length of 3 mm as taught by Shimada for the purpose of providing visibility with minimal covering of anatomical structures increasing precision by having a reduced portion which provides better location identification when compared to a larger size ([0082]).
Regarding claim 19, Tsueta/Hiroshige discloses the catheter according to Claim 1. Tsueta discloses wherein the radiopaque marker (21) is a tubular radiopaque marker (Fig 5). Tsueta is silent regarding a length of the tubular radiopaque marker being 3 mm to 10 mm.
Shimada teaches a catheter (catheter subassembly 600, Fig 5) comprising a radiopaque marker (radiopaque marker band 610; [0082]) possesses an axial length of 0.5 mm to 10 mm ([0082]: “The radiopaque marker 610 can comprise a length of about 0.5 mm to about 5-mm.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the length radiopaque marker of device of Tsueta/Hiroshige with a length of 3 mm as taught by Shimada for the purpose of providing visibility with minimal covering of anatomical structures increasing precision by having a reduced portion which provides better location identification when compared to a larger size ([0082]).
Claim 12-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. JP2012055469A in view of Tsukumo et al. (JP2007319594A).
Regarding claim 12, Tsueta discloses a catheter (catheter 49, Fig 5) comprising: a tubular shaft (shaft 42 has tubular shape, Fig 5) including a distal end (distal side Ts, Fig 5) and a proximal end (terminal side Es, Fig 5) at opposite axial ends of the tubular shaft (distal Ts and proximal Es ends of tubular shaft 42 are located at opposite axial ends, see Fig 5), the tubular shaft (42) possessing an inner surface (1006, Annotated Fig 2) facing a hollow interior (hollow interior 1011, Fig 2) of the tubular shaft (42) and an outer surface (1012, Annotated Fig 2); the tubular shaft (42) including an inner layer (inner layer 31, Fig 5), an outer layer (outer layer 33, Fig 5), and a braid (metal braid reinforcing layer 32, [0038, Fig 5]) positioned radially inwardly of the outer surface (1012, Annotated Fig 2) of the tubular shaft (42) and radially outwardly of the inner surface (1006, Annotated Fig 2) of the tubular shaft (42), the braid (32) including a plurality of metal wires that are woven together (metal braid is formed of metal wires woven together in a certain pattern; [0038], not explicit); the braid (32) including a distal end portion (1013, Annotated Fig 1) terminating at a distal-most end (1001, Annotated Fig 1) of the distal portion (1013, Annotated Fig 1) of the braid (32), the plurality of metal wires (metal braid is formed of metal wires woven together in a certain pattern; [0038], not explicit) in the distal portion (1013, Annotated Fig 1) of the braid (32) being welded together (welding portion 1000 of braid comprising metal braid wires welded together circumferentially around the marker stopper 11, [0050]; Fig 5) and constituting a welding portion (1000, Annotated Fig 1), the distal end (Ts) of the tubular shaft (42) being positioned distal of a distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) of the braid (32), the welding portion (1000, Annotated Fig 1) also having a proximal-most end (1002, Annotated Fig 1) opposite the distal-most end (1003, Annotated Fig 1)of the welding portion (32); the shaft (42) including a radiopaque marker (21) positioned radially inwardly of the outer surface (1012, Annotated Fig 2) of the tubular shaft (42) and radially outwardly of an outer surface (1015, Annotated Fig 1) of the braid (32), the radiopaque marker (21) being a coil ([0092]: marker 21 is not limited to ring-shaped and could also have a coiled structure), the coil (21) including a distal-most end (1004, Annotated Fig 2) and a proximal-most end (1008, Annotated Fig 2), an entirety of the welding portion (1000, Annotated Fig 1) being located on a distal side of the distal-most end (1004, Annotated Fig 2) of the coil (21) so that a space (1005, Annotated Fig 2) exists between the proximal-most end (1002, Annotated Fig 2) of the welding portion and the distal-most end (1004, Annotated Fig 2) of the coil (21), the braid (32) extending proximally beyond a proximal-most end (1008, Annotated Fig 2) of the coil (21); and the coil (21) constitutes the radiopaque marker (21); an imaginary continuation (1016, Annotated Fig 1) of the inner surface of the radiopaque marker (inner surface of radiopaque marker 21, Fig 5) in the distal direction being positioned radially outwardly of and spaced radially outwardly (Annotated Fig 1) from an outer surface of all the wires in the braid (metal braid is formed of metal wires woven together in a certain pattern ; [0038], not explicit) that are welded together in the welding portion (welding portion 1000, includes a metal braid portion comprised of wires woven together; [0038]; [0050]).
Tsueta discloses the thickness (1014, Annotated Fig 3) of the coil (21) being less than a distance (L2, Annotated Fig 3) from the distal-most end (1003, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) to the distal-most end (1004, Annotated Fig 1) of the radiopaque marker (21).
Tsueta is silent regarding the metal radiopaque marker coil being comprised of a wire that is wound in a coil, and an outer diameter of the wire being less than a distance from the distal-most end of the welding portion to the distal-most end of the radiopaque marker.
Tsukumo teaches a catheter (Fig 3) comprising a radiopaque marker (X-ray opaque metal marker 6, Fig 3) comprised of a wire that is wound in a coil and an outer diameter ([0035]: “Furthermore, the metal marker 6 having radiopacity may be formed by winding a radiopaque metal wire in a coil shape. When metal wire is used, it is preferred that the diameter be between 5 and 60 microns”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Tsueta with similar coil wire marker as taught by Tsukumo for the purpose to ensure sufficient visibility and flexibility of the radiopaque markers with minimal or no increase in overall catheter diameter ([0017];[0035](Note: the overall dimensions of radiopaque marker of Tsueta are maintained, the diameter of the coil wire would be equivalent to the thickness of radiopaque marker of Tsueta)
Regarding claim 13, Tsueta/Tsukumo discloses the catheter according to Claim 12. Tsueta discloses wherein the radiopaque marker (21) has a length (L1, Annotated Fig 1) in an axial direction of the shaft (42), and the length (L1, Annotated Fig 1) of the radiopaque marker (21) in the axial direction being greater than a distance (L3, Annotated Fig 1) from the proximal-most end (1002, Annotated Fig 1) of the welding portion (1000, Annotated Fig 1) to a distal end (1004, Annotated Fig 1) of the radiopaque marker (21).
Regarding claim 16, Tsueta/Tsukumo discloses the catheter according to Claim 12. Tsueta discloses wherein the coil wire (coil 21 of Tsueta modified with teaching of Tsukumo, see claim 12) is made of metal that is recognizable under radiography (coil 21 is made of a radiopaque material which is recognizable in a radiography [0041]).
Claim 14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. JP2012055469A in further view of Tsukumo et al. (JP2007319594A) in further view of Shimada et al. (US 20190046763 A1)
Regarding claim 14, Tsueta/Tsukumo discloses the catheter according to Claim 13. Tsueta discloses wherein the radiopaque marker (21) is a tubular radiopaque marker (Fig 2 shows tubular shape of marker 21 in a cross-sectional view).
Tsueta/Tsukumo are silent regarding the length of the tubular radiopaque marker being 3 mm to 10 mm.
Shimada teaches a catheter (catheter subassembly 600, Fig 5) comprising a radiopaque marker (radiopaque marker band 610; [0082]) the length of the tubular radiopaque marker being 3 mm to 10 mm ([0082]: “The radiopaque marker 610 can comprise a length of about 0.5 mm to about 5-mm.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the length radiopaque marker of device of Tsueta/Tsukumo with a length of 3 mm as taught by Shimada for the purpose of providing visibility with minimal covering of anatomical structures increasing precision by having a reduced portion which provides better location identification when compared to a larger size ([0082])
Regarding claim 17, Tsueta/Tsukumo discloses the catheter according to Claim 12.
Tsueta/Tsukumo are silent wherein the radiopaque marker possesses an axial length of 0.5 mm to 10 mm.
Shimada teaches a catheter (catheter subassembly 600, Fig 5) comprising a radiopaque marker (radiopaque marker band 610; [0082]) possesses an axial length of 0.5 mm to 10 mm ([0082]: “The radiopaque marker 610 can comprise a length of about 0.5 mm to about 5-mm.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the length radiopaque marker of device of Tsueta/Tsukumo with a length of 3 mm as taught by Shimada for the purpose of providing visibility with minimal covering of anatomical
Regarding claim 20, Tsueta/Tsukumo discloses the catheter according to Claim 12. Tsueta discloses the radiopaque marker (21) is a tubular radiopaque marker (Fig 5). Tsueta/Tsukumo are silent wherein a length of the tubular radiopaque marker being 3 mm to 10 mm.
Shimada teaches a catheter (catheter subassembly 600, Fig 5) comprising a radiopaque marker (radiopaque marker band 610; [0082]) a length of the tubular radiopaque marker being 3 mm to 10 mm ([0082]: “The radiopaque marker 610 can comprise a length of about 0.5 mm to about 5-mm.”)
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the length radiopaque marker of device of Tsueta/Tsukumo with a length of 3 mm as taught by Shimada for the purpose of providing visibility with minimal covering of anatomical.
Regarding claim 22, Tsueta/Tsukumo discloses the catheter according to Claim 12. Tsueta is silent wherein the welding portion is at a most distal end of the braid.
Hiroshige teaches Hiroshige teaches a catheter (Fig 1) comprising woven wires (woven wires 26a and 26b, Fig 4A) being welded together at the intersection points (intersections 30, Fig 4A-4C ) in the welding portion ([0036]) wherein the welding portion is at a most distal end of the braid (26a-b) (Fig 4B-C; [0036]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the welding portion of device of Tsueta/Hiroshige to incorporate welding at the intersection points of the woven wires and a similar bulging portion at the cut off distal end portion as taught by Hiroshige for the purpose of reducing the risk that the wires will spread apart and increase their welding strength ([0007;[0036]; [0045]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Tsueta et al. JP2012055469A in view of Tsukumo et al. (JP2007319594A) in further view of Gunderson et al. (US 20080125752 A1).
Regarding Claim 24, Tsueta/Tsukumo discloses the catheter according to Claim 12. Tsueta is silent wherein a radially outer facing surface of the welding portion and a most distal end of the braid face toward the outer surface of the tubular shaft, the radially outer facing surface of the welding portion and the most distal end of the braid being in contact with and covered solely by the outer layer.
Gunderson teaches a catheter (Fig 9-11) comprising a welding portion (456a/456b/456c/456d/456e, Fig 11; [0036]) wherein a radially outer facing surface (2001, Annotated Fig 4) of the welding portion (2000, Annotated Fig 4) and a most distal end of the braid face (2002, Annotated Fig 4) toward the outer surface (2003, Annotated Fig 4) of the tubular shaft (2004, Annotated Fig 4), the radially outer facing surface (2001, Annotated Fig 4) of the welding portion (2000, Annotated Fig 4) and the most distal end of the braid (2002, Annotated Fig 4) being in contact with and covered solely by the outer layer (462, Fig 11).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the welding portion device of Tsueta/Tsukumo to include a series of circumferential spot welds in the braid intersection points in contact and covered by the outer layer as taught by Gunderson for the purpose of further secure the reinforcement member wires ([0036]).
Response to Arguments
Applicant’s arguments with respect to claims 1-14, 16-17, and 19-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Please note that the claim limitations related to the welding portion does not limit the welding portion to only the intersection points of the woven braid wires; it could comprise other elements or sections being welded in addition to the intersection points of the woven braid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783
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