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 .
Response to Amendment
The amendments filed 04 December 2025 have been entered. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112(b) previously set forth in the Office Action mailed 22 September 2025.
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.
Claim(s) 1-9 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nesbitt (US 20090181156 A1) in view of Kamiya (JP 2014239742 A).
Regarding claim 1, Nesbitt discloses an elongated medical device (Paragraph 0153, 0159—the medical device is prepared for coating… the medical device is a medical guide wire 330; medical guidewire 330) comprising:
a first layer having a hollow cylindrical shape and containing a fluororesin having an adhesive functional group and a first colorant (Block 312; first coating 338; Paragraph 0153, 0160-0161, 0173-- a first or base low-friction coating or layer including a low-friction material, such as PTFE or any suitable low-friction material described herein, is applied to the surface of the medical device as indicated in block 312. In one embodiment, the first low-friction coating includes a first colored pigment, such as a relatively dark colored pigment (e.g., a blue, black, purple or green colored pigment). In another embodiment, the first low-friction coating includes a first colored pigment, such as a relatively light colored pigment (e.g., a white, yellow or orange colored pigment)); and
a second layer in contact with an outer peripheral surface of the first layer and having a predetermined colored region formed of a second colorant having a color different from a color of the first colorant (Block 320; second layer 342; paragraph 0150, 0156, 0169-0174-- a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device…After blocking or shielding one or more unblocked parts or portions of the medical device, a second, low-friction coating or layer including a low-friction material, such as PTFE or any suitable low-friction material described herein, is applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device as indicated in block 320… In one embodiment in which the first low-friction coating includes a first relatively dark colored pigment, the second low-friction coating includes a second contrasting colored pigment, such as a relatively light colored pigment (e.g., a white colored pigment). In another embodiment in which the first low-friction coating includes a first relatively light colored pigment, the second low-friction coating includes a second contrasting colored pigment, such as a relatively dark colored pigment (e.g., a white colored pigment)); wherein
the predetermined colored region is formed on a part of the outer peripheral surface of the first layer (Block 320; second layer 342; paragraph 0156, 0169-0174-- applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device…), and
the fluororesin having the adhesive functional group is a resin copolymerized from a fluorine-containing ethylenic monomer (Paragraph 0014, 0153, 0160-0161, 0173-- a first or base low-friction coating or layer including a low-friction material, such as PTFE or any suitable low-friction material described herein…; paragraph 0173-- the first low-friction coating and/or the second low friction coating may alternatively include or also include one or more of the following materials: PTFE, PFA, FEP, PE, PEEK, PEK, amide imide, imide, polyethersulfone (PES), polyimide amide (PAI), polyaranylsulfone, polyphenelyhenesupsfide (PPS), epoxy, silicone, phenolic, phenoxy, polyimide, polyamide, polyamide-amide, polyphenylene sulfide, polyarylsulfone, polyethylene, fluorinated ethylene propylene, perfluoroalkoxy, any suitable binder or resin…).
Nesbitt does not explicitly disclose an adhesive functional group-containing ethylenic monomer.
Kamiya, in the same field of endeavor of an elongated medical device having layers, discloses the device includes a layer containing a fluororesin having an adhesive functional group, the fluororesin having the adhesive functional group is a resin copolymerized from a fluorine-containing ethylenic monomer and an adhesive functional group-containing ethylenic monomer, wherein the adhesive functional group is a carbonyl group (“The adhesive fluorocarbon resin is made of a polymer having a monomer unit derived from fluorine-containing ethylenic monomer”…” for example , tetrafluoroethylene [TFE] , vinylidene fluoride [ VdF ] , Kurorotori [CTFE ] , vinyl fluoride [ VF ] , hexafluoropropylene [HFP] , hexafluoroisobutene , perfluoro(alkylvinylether)”…”As the adhesive fluorocarbon resin , from the viewpoint of excellent adhesion , preferably has an adhesive functional group”…”As the adhesive functional group is not particularly limited as long as capable of intermolecular interactions or such as hydrogen bonds can react with the polar functional groups of the elastomer forming the outer layer has a carbonyl group”…”The adhesive functional group having the carbonyl group , for example , a carbonyl group , a carbonate group , haloformyl group”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt, comprising “any suitable low-friction material described herein” including PTFE and PFA and “any suitable binder or resin”, to utilize an adhesive functional group-containing ethylenic monomer as described by Kamiya in order to predictably improve the adhesion of the colored pigments to the layer and maintain strength of the device while utilizing a low-friction material such as PTFE or PFA as a fluororesin.
Regarding claim 2, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses wherein the predetermined colored region is in a transparent resin different from the fluororesin having the adhesive functional group (Paragraph 0150, 0173-- In another embodiment, a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device. In one embodiment, the top coating is a low-friction or release coating or material, such as fluorinated materials, polytetrafluoroethylene, perfluoro-alkoxy, fluoroethylenepropylene, MFA, polyethylene, silicone, a resin like clear medical grade epoxy in liquid or power form, ceramic composites, paralyene silane polymers and other suitable low-friction coatings. Such a top coating provides that the markings described above are substantially covered or sealed underneath an additional layer skin of a low friction coating…the first low-friction coating and/or the second low friction coating may alternatively include or also include one or more of the following materials: PTFE, PFA, FEP, PE, PEEK, PEK, amide imide, imide, polyethersulfone (PES), polyimide amide (PAI), polyaranylsulfone, polyphenelyhenesupsfide (PPS), epoxy, silicone, phenolic, phenoxy, polyimide, polyamide, polyamide-amide, polyphenylene sulfide, polyarylsulfone, polyethylene, fluorinated ethylene propylene, perfluoroalkoxy, any suitable binder or resin, any suitable organic pigment …).
Regarding claim 3, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses wherein the transparent resin is at least one selected from a group consisting of polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkylvinylether copolymer, tetrafluoroethylene- hexafluoropropylene copolymer, nylon, and urethane (Paragraph 0150, 0173-- In another embodiment, a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device. In one embodiment, the top coating is a low-friction or release coating or material, such as fluorinated materials, polytetrafluoroethylene, perfluoro-alkoxy, fluoroethylenepropylene, MFA, polyethylene, silicone, a resin like clear medical grade epoxy in liquid or power form, ceramic composites, paralyene silane polymers and other suitable low-friction coatings. Such a top coating provides that the markings described above are substantially covered or sealed underneath an additional layer skin of a low friction coating…the first low-friction coating and/or the second low friction coating may alternatively include or also include one or more of the following materials: PTFE, PFA, FEP, PE, PEEK, PEK, amide imide, imide, polyethersulfone (PES), polyimide amide (PAI), polyaranylsulfone, polyphenelyhenesupsfide (PPS), epoxy, silicone, phenolic, phenoxy, polyimide, polyamide, polyamide-amide, polyphenylene sulfide, polyarylsulfone, polyethylene, fluorinated ethylene propylene, perfluoroalkoxy, any suitable binder or resin, any suitable organic pigment …).
Regarding claim 4, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses further comprising a metal core wire arranged in contact with an inner peripheral surface of the first layer (Fig. 35A, outer surface 336 of the guidewire is in contact with the inner peripheral surface; block 310-312; paragraph 0160-- a first or base low-friction coating 338 including a low-friction material, such as PTFE, is applied to the outer surface of the illustrated medical guide wire 336).
Regarding claim 5, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses an adhesive intermediate layer having a hollow cylindrical shape in contact with the inner peripheral surface of the first layer (Paragraph 0084-- In another embodiment, a powder coating system is employed. This powder coating system includes a primer, where required, of a liquid that is preapplied and either cured to dry or remains wet prior to the application of a topcoat of a powder. In this embodiment, the powder may include a low-friction material such as PFA, FEP, PTFE, PE, PEEK, PEK or appropriate low-friction particles or a combination of the above plus appropriate pigments similar to those described in the liquid-type coatings described above; paragraph 0117-- a steel medical wire is treated with an iron, zinc, or manganese phosphate, which penetrates the steel surface and coats the surface of the medical wire with a thin layer of the phosphate, which promotes the adhesion of a coating, improves corrosion resistance, and improves the chemical protection of the medical wire) and a metal core wire in contact with an inner peripheral surface of the intermediate layer (Paragraph 0178-- if the method described herein applies the first low-friction coating or utilizes a medical guide wire that has been precoated with a first low-friction coating, the second low-friction coating is selectively applied to and bonds with such first low-friction coatings in the formation of the spiral shaped medical guide wire described herein).
Regarding claim 6, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses further comprising a metal layer having a hollow cylindrical shape in contact with the inner peripheral surface of the first layer (Paragraph 0117--a steel medical wire is treated with an iron, zinc, or manganese phosphate, which penetrates the steel surface and coats the surface of the medical wire with a thin layer of the phosphate, which promotes the adhesion of a coating, improves corrosion resistance, and improves the chemical protection of the medical wire).
Regarding claim 7, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses further comprising a sliding layer having a hollow cylindrical shape and disposed on an innermost side of the elongated medical device in a radial direction (Paragraph 0084-- In another embodiment, a powder coating system is employed. This powder coating system includes a primer, where required, of a liquid that is preapplied and either cured to dry or remains wet prior to the application of a topcoat of a powder. In this embodiment, the powder may include a low-friction material such as PFA, FEP, PTFE, PE, PEEK, PEK or appropriate low-friction particles or a combination of the above plus appropriate pigments similar to those described in the liquid-type coatings described above; paragraph 0117-- a steel medical wire is treated with an iron, zinc, or manganese phosphate, which penetrates the steel surface and coats the surface of the medical wire with a thin layer of the phosphate, which promotes the adhesion of a coating, improves corrosion resistance, and improves the chemical protection of the medical wire).
Regarding claim 8, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses wherein the predetermined color region includes a plurality of second colorant regions spaced apart from one another along a longitudinal direction of the elongated medical device (Paragraph 0149, 0151, 0169-- That is, the second low-friction can be applied to the surface of the medical device as one or more: bands, parallel lines, bands or stripes, perpendicular lines, bands or stripes, transverse lines, bands or stripes, axial lines, bands or stripes, longitudinal lines, bands or stripes, spiral patterned lines, bands or stripes, letters, numbers, bar codes, alpha numeric marks, and/or marks…the second low-friction coating is applied along an unprotected or unmasked longitudinally extending portion of the coated surface to form a linear strip or band along part, but not all of, the length of the coated surface of the twisted medical guide wire).
Regarding claim 9, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 8. Nesbitt additionally discloses wherein each of the plurality of second colorant regions surround the outer peripheral surface of the first layer (Block 320; second layer 342; paragraph 0156, 0169-0174-- applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device…).
Regarding claim 11, the combination of Nesbitt and Kamiya teach the elongated medical device according to claim 1. Nesbitt does not explicitly disclose wherein the adhesive functional group is a carbonyl group. Kamiya additionally teaches wherein the adhesive functional group is a carbonyl group (“The adhesive fluorocarbon resin is made of a polymer having a monomer unit derived from fluorine-containing ethylenic monomer”…” for example , tetrafluoroethylene [TFE] , vinylidene fluoride [ VdF ] , Kurorotori [CTFE ] , vinyl fluoride [ VF ] , hexafluoropropylene [HFP] , hexafluoroisobutene , perfluoro(alkylvinylether)”…”As the adhesive fluorocarbon resin , from the viewpoint of excellent adhesion , preferably has an adhesive functional group”…”As the adhesive functional group is not particularly limited as long as capable of intermolecular interactions or such as hydrogen bonds can react with the polar functional groups of the elastomer forming the outer layer has a carbonyl group”…”The adhesive functional group having the carbonyl group , for example , a carbonyl group , a carbonate group , haloformyl group”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt, comprising “any suitable low-friction material described herein” including PTFE and PFA and “any suitable binder or resin”, to utilize an adhesive functional group-containing ethylenic monomer such as a carbonyl group as described by Kamiya in order to predictably improve the adhesion of the colored pigments to the layer and maintain strength of the device while utilizing a low-friction material such as PTFE or PFA as a fluororesin.
Regarding claim 12, the combination of Nesbitt and Kamiya teach the elongated medical device according to claim 1. Nesbitt does not explicitly disclose wherein the adhesive functional group comprises at least one selected from the group consisting of a carbonate group and a halogenoformyl group. Kamiya additionally teaches wherein the adhesive functional group comprises at least one selected from the group consisting of a carbonate group and a halogenoformyl group (“The adhesive fluorocarbon resin is made of a polymer having a monomer unit derived from fluorine-containing ethylenic monomer”…” for example , tetrafluoroethylene [TFE] , vinylidene fluoride [ VdF ] , Kurorotori [CTFE ] , vinyl fluoride [ VF ] , hexafluoropropylene [HFP] , hexafluoroisobutene , perfluoro(alkylvinylether)”…”As the adhesive fluorocarbon resin , from the viewpoint of excellent adhesion , preferably has an adhesive functional group”…”As the adhesive functional group is not particularly limited as long as capable of intermolecular interactions or such as hydrogen bonds can react with the polar functional groups of the elastomer forming the outer layer has a carbonyl group”…”The adhesive functional group having the carbonyl group , for example , a carbonyl group , a carbonate group , haloformyl group”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt, comprising “any suitable low-friction material described herein” including PTFE and PFA and “any suitable binder or resin”, to utilize an adhesive functional group-containing ethylenic monomer such as a carbonate group or a halogenoformyl group as described by Kamiya in order to predictably improve the adhesion of the colored pigments to the layer and maintain strength of the device while utilizing a low-friction material such as PTFE or PFA as a fluororesin.
Regarding claim 13, the combination of Nesbitt and Kamiya teaches the elongated medical device according to claim 7. Nesbitt fails to explicitly disclose further comprising a metal layer between the sliding layer and the first layer, wherein the metal layer includes a braided body of strands having gaps, and wherein the fluororesin of the first layer penetrates the gaps to bond with the sliding layer.
Kamiya discloses a sliding layer (“inner layer”), a first layer (“outer layer”), and a metal layer (“Reinforcing layer”) between the sliding layer and the first layer (“it is provided between the inner and outer layers , it is one preferred form , including a reinforcing layer is formed of a metal or resin”), wherein the metal layer includes a braided body of strands (“The reinforcing layer , a coil , or it is preferable that the metal wires or synthetic resin strands is formed by braiding the interwoven…”) and wherein the fluororesin of the first layer penetrates the gaps to bond with the sliding layer (“If having a reinforcing layer , an outer layer and the inner layer are bonded by a coil or braid of the gap is reinforcing layer . Thus , part of the inner surface of the outer layer is bonded to the inner layer of the outer surface”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt to include a reinforcing layer as disclosed by Kamiya in order to predictably improve the strength and kink resistance of the elongated medical device (see Kamiya “The reinforcing layer , a coil , or it is preferable that the metal wires or synthetic resin strands is formed by braiding the interwoven…”).
Claim(s) 1-3, 7-9, and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nesbitt (US 20090181156 A1) in view of Kamiya (JP 2014239742 A).
Regarding claim 1, Nesbitt discloses an elongated medical device (Paragraph 0153, 0159—the medical device is prepared for coating… the medical device is a medical guide wire 330; medical guidewire 330) comprising:
a first layer having a hollow cylindrical shape and containing a fluororesin having an adhesive functional group and a first colorant (paragraph 0150, 0156, 0169-0174-- a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device…After blocking or shielding one or more unblocked parts or portions of the medical device, a second, low-friction coating or layer including a low-friction material, such as PTFE or any suitable low-friction material described herein, is applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device as indicated in block 320… In one embodiment in which the first low-friction coating includes a first relatively dark colored pigment, the second low-friction coating includes a second contrasting colored pigment, such as a relatively light colored pigment (e.g., a white colored pigment). In another embodiment in which the first low-friction coating includes a first relatively light colored pigment, the second low-friction coating includes a second contrasting colored pigment, such as a relatively dark colored pigment (e.g., a white colored pigment); paragraph 0181-0182-- a second, different colored low-friction coating is applied along a first portion of a twisted medical guide wire (as described above) and the medical guide wire is then twisted more and a third, contrasting colored low-friction coating is then applied along a second portion of this further twisted medical guide wire). NOTE: In this interpretation, the second coating of Nesbitt corresponds to the first layer)); and
a second layer in contact with an outer peripheral surface of the first layer and having a predetermined colored region formed of a second colorant having a color different from a color of the first colorant (paragraph 0150, 0156, 0169-0174-- a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device…After blocking or shielding one or more unblocked parts or portions of the medical device, a second, low-friction coating or layer including a low-friction material, such as PTFE or any suitable low-friction material described herein, is applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device as indicated in block 320… In one embodiment in which the first low-friction coating includes a first relatively dark colored pigment, the second low-friction coating includes a second contrasting colored pigment, such as a relatively light colored pigment (e.g., a white colored pigment). In another embodiment in which the first low-friction coating includes a first relatively light colored pigment, the second low-friction coating includes a second contrasting colored pigment, such as a relatively dark colored pigment (e.g., a white colored pigment); paragraph 0181-0182-- a second, different colored low-friction coating is applied along a first portion of a twisted medical guide wire (as described above) and the medical guide wire is then twisted more and a third, contrasting colored low-friction coating is then applied along a second portion of this further twisted medical guide wire). NOTE: In this interpretation, the third coating of Nesbitt corresponds to the second layer)); wherein
the predetermined colored region is formed on a part of the outer peripheral surface of the first layer (paragraph 0156, 0169-0174-- applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device…; paragraph 0181-0182-- a second, different colored low-friction coating is applied along a first portion of a twisted medical guide wire (as described above) and the medical guide wire is then twisted more and a third, contrasting colored low-friction coating is then applied along a second portion of this further twisted medical guide wire).
Regarding claim 2, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses wherein the predetermined colored region is in a transparent resin different from the fluororesin having the adhesive functional group (Paragraph 0150, 0173-- In another embodiment, a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device. In one embodiment, the top coating is a low-friction or release coating or material, such as fluorinated materials, polytetrafluoroethylene, perfluoro-alkoxy, fluoroethylenepropylene, MFA, polyethylene, silicone, a resin like clear medical grade epoxy in liquid or power form, ceramic composites, paralyene silane polymers and other suitable low-friction coatings. Such a top coating provides that the markings described above are substantially covered or sealed underneath an additional layer skin of a low friction coating…the first low-friction coating and/or the second low friction coating may alternatively include or also include one or more of the following materials: PTFE, PFA, FEP, PE, PEEK, PEK, amide imide, imide, polyethersulfone (PES), polyimide amide (PAI), polyaranylsulfone, polyphenelyhenesupsfide (PPS), epoxy, silicone, phenolic, phenoxy, polyimide, polyamide, polyamide-amide, polyphenylene sulfide, polyarylsulfone, polyethylene, fluorinated ethylene propylene, perfluoroalkoxy, any suitable binder or resin, any suitable organic pigment …).
Regarding claim 3, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses wherein the transparent resin is at least one selected from a group consisting of polytetrafluoroethylene, tetrafluoroethylene-perfluoroalkylvinylether copolymer, tetrafluoroethylene- hexafluoropropylene copolymer, nylon, and urethane (Paragraph 0150, 0173-- In another embodiment, a clear or transparent top coat is applied to one or more of the surfaces of the coated medical device after the second low-friction coating has been selectively applied to the exposed surfaces of the medical device. In one embodiment, the top coating is a low-friction or release coating or material, such as fluorinated materials, polytetrafluoroethylene, perfluoro-alkoxy, fluoroethylenepropylene, MFA, polyethylene, silicone, a resin like clear medical grade epoxy in liquid or power form, ceramic composites, paralyene silane polymers and other suitable low-friction coatings. Such a top coating provides that the markings described above are substantially covered or sealed underneath an additional layer skin of a low friction coating…the first low-friction coating and/or the second low friction coating may alternatively include or also include one or more of the following materials: PTFE, PFA, FEP, PE, PEEK, PEK, amide imide, imide, polyethersulfone (PES), polyimide amide (PAI), polyaranylsulfone, polyphenelyhenesupsfide (PPS), epoxy, silicone, phenolic, phenoxy, polyimide, polyamide, polyamide-amide, polyphenylene sulfide, polyarylsulfone, polyethylene, fluorinated ethylene propylene, perfluoroalkoxy, any suitable binder or resin, any suitable organic pigment …).
Regarding claim 7, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses further comprising a sliding layer having a hollow cylindrical shape and disposed on an innermost side of the elongated medical device in a radial direction (Block 312; first coating 338; Paragraph 0153, 0160-0161, 0173-- a first or base low-friction coating or layer including a low-friction material, such as PTFE or any suitable low-friction material described herein, is applied to the surface of the medical device as indicated in block 312. In one embodiment, the first low-friction coating includes a first colored pigment, such as a relatively dark colored pigment (e.g., a blue, black, purple or green colored pigment). In another embodiment, the first low-friction coating includes a first colored pigment, such as a relatively light colored pigment (e.g., a white, yellow or orange colored pigment); Paragraph 0181-0182-- a second, different colored low-friction coating is applied along a first portion of a twisted medical guide wire (as described above) and the medical guide wire is then twisted more and a third, contrasting colored low-friction coating is then applied along a second portion of this further twisted medical guide wire NOTE: these second and third layers are disposed on top of a first coating, where the first coating of Nesbitt corresponds to the sliding layer).
Regarding claim 8, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 1. Nesbitt additionally discloses wherein the predetermined color region includes a plurality of second colorant regions spaced apart from one another along a longitudinal direction of the elongated medical device (Paragraph 0149, 0151, 0169-- That is, the second low-friction can be applied to the surface of the medical device as one or more: bands, parallel lines, bands or stripes, perpendicular lines, bands or stripes, transverse lines, bands or stripes, axial lines, bands or stripes, longitudinal lines, bands or stripes, spiral patterned lines, bands or stripes, letters, numbers, bar codes, alpha numeric marks, and/or marks…the second low-friction coating is applied along an unprotected or unmasked longitudinally extending portion of the coated surface to form a linear strip or band along part, but not all of, the length of the coated surface of the twisted medical guide wire; paragraph 0181-0182-- a second, different colored low-friction coating is applied along a first portion of a twisted medical guide wire (as described above) and the medical guide wire is then twisted more and a third, contrasting colored low-friction coating is then applied along a second portion of this further twisted medical guide wire).
Regarding claim 9, the combination of Nesbitt and Kamiya discloses the elongated medical device of claim 8. Nesbitt additionally discloses wherein each of the plurality of second colorant regions surround the outer peripheral surface of the first layer (Block 320; second layer 342; paragraph 0156, 0169-0174-- applied to a lengthwise or partial lengthwise portion of the coated surface of the medical device…; paragraph 0181-0182-- a second, different colored low-friction coating is applied along a first portion of a twisted medical guide wire (as described above) and the medical guide wire is then twisted more and a third, contrasting colored low-friction coating is then applied along a second portion of this further twisted medical guide wire).
Regarding claim 11, the combination of Nesbitt and Kamiya teach the elongated medical device according to claim 1. Nesbitt does not explicitly disclose wherein the adhesive functional group is a carbonyl group. Kamiya additionally teaches wherein the adhesive functional group is a carbonyl group (“The adhesive fluorocarbon resin is made of a polymer having a monomer unit derived from fluorine-containing ethylenic monomer”…” for example , tetrafluoroethylene [TFE] , vinylidene fluoride [ VdF ] , Kurorotori [CTFE ] , vinyl fluoride [ VF ] , hexafluoropropylene [HFP] , hexafluoroisobutene , perfluoro(alkylvinylether)”…”As the adhesive fluorocarbon resin , from the viewpoint of excellent adhesion , preferably has an adhesive functional group”…”As the adhesive functional group is not particularly limited as long as capable of intermolecular interactions or such as hydrogen bonds can react with the polar functional groups of the elastomer forming the outer layer has a carbonyl group”…”The adhesive functional group having the carbonyl group , for example , a carbonyl group , a carbonate group , haloformyl group”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt, comprising “any suitable low-friction material described herein” including PTFE and PFA and “any suitable binder or resin”, to utilize an adhesive functional group-containing ethylenic monomer such as a carbonyl group as described by Kamiya in order to predictably improve the adhesion of the colored pigments to the layer and maintain strength of the device while utilizing a low-friction material such as PTFE or PFA as a fluororesin.
Regarding claim 12, the combination of Nesbitt and Kamiya teach the elongated medical device according to claim 1. Nesbitt does not explicitly disclose wherein the adhesive functional group comprises at least one selected from the group consisting of a carbonate group and a halogenoformyl group. Kamiya additionally teaches wherein the adhesive functional group comprises at least one selected from the group consisting of a carbonate group and a halogenoformyl group (“The adhesive fluorocarbon resin is made of a polymer having a monomer unit derived from fluorine-containing ethylenic monomer”…” for example , tetrafluoroethylene [TFE] , vinylidene fluoride [ VdF ] , Kurorotori [CTFE ] , vinyl fluoride [ VF ] , hexafluoropropylene [HFP] , hexafluoroisobutene , perfluoro(alkylvinylether)”…”As the adhesive fluorocarbon resin , from the viewpoint of excellent adhesion , preferably has an adhesive functional group”…”As the adhesive functional group is not particularly limited as long as capable of intermolecular interactions or such as hydrogen bonds can react with the polar functional groups of the elastomer forming the outer layer has a carbonyl group”…”The adhesive functional group having the carbonyl group , for example , a carbonyl group , a carbonate group , haloformyl group”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt, comprising “any suitable low-friction material described herein” including PTFE and PFA and “any suitable binder or resin”, to utilize an adhesive functional group-containing ethylenic monomer such as a carbonate group or a halogenoformyl group as described by Kamiya in order to predictably improve the adhesion of the colored pigments to the layer and maintain strength of the device while utilizing a low-friction material such as PTFE or PFA as a fluororesin.
Regarding claim 13, the combination of Nesbitt and Kamiya teaches the elongated medical device according to claim 7. Nesbitt fails to explicitly disclose further comprising a metal layer between the sliding layer and the first layer, wherein the metal layer includes a braided body of strands having gaps, and wherein the fluororesin of the first layer penetrates the gaps to bond with the sliding layer.
Kamiya discloses a sliding layer (“inner layer”), a first layer (“outer layer”), and a metal layer (“Reinforcing layer”) between the sliding layer and the first layer (“it is provided between the inner and outer layers , it is one preferred form , including a reinforcing layer is formed of a metal or resin”), wherein the metal layer includes a braided body of strands (“The reinforcing layer , a coil , or it is preferable that the metal wires or synthetic resin strands is formed by braiding the interwoven…”) and wherein the fluororesin of the first layer penetrates the gaps to bond with the sliding layer (“If having a reinforcing layer , an outer layer and the inner layer are bonded by a coil or braid of the gap is reinforcing layer . Thus , part of the inner surface of the outer layer is bonded to the inner layer of the outer surface”).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt to include a reinforcing layer as disclosed by Kamiya in order to predictably improve the strength and kink resistance of the elongated medical device (see Kamiya “The reinforcing layer , a coil , or it is preferable that the metal wires or synthetic resin strands is formed by braiding the interwoven…”).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nesbitt in view of Kamiya, further in view of Cornish (US 20120065622 A1).
Regarding claim 10, Nesbitt in view of Kamiya discloses the elongated medical device of claim 8. Nesbitt additionally discloses the plurality of second colorant regions may positioned on a particular portion of the device in order to delineate a particular length or portion of the device (Paragraph 0002, 0016, 0183, 0186-- The color of the pigment (within the matrix of the coating) is shifted in selected locations along the length of the device such that the different colors serve as visual indicia which indicate a designated marking that may denote length of the medical device or a designated position on the medical device…the medical guide wire with one or more spiral shaped patterns also includes one or more: portions coated with different colored first low-friction coatings, bands which indicate distance (as described above), longitudinal lines which indicate distance, parallel lines, bands or stripes, perpendicular lines, bands or stripes, transverse lines, bands or stripes, axial lines, bands or stripes, longitudinal lines, bands or stripes, spiral patterned lines, bands or stripes…).
However, Nesbitt does not explicitly disclose further comprising a dilation portion, wherein the plurality of second colorant regions are positioned in the dilation portion.
Cornish, in the same field of endeavor of a color coded guidewire (Abstract), discloses a device comprising a dilation portion (Paragraph 0001-0003-- guide wires for advancing intraluminal devices such as stent delivery catheters, balloon dilatation catheters… a guide wire is positioned within an inner lumen of an OTW device such as a dilatation catheter or stent delivery catheter with the distal tip of the guide wire just proximal to the distal tip of the catheter and then both are advanced through the guiding catheter to the distal end thereof. The guide wire is first advanced out of the distal end of the guiding catheter into the patient's coronary vasculature until the distal end of the guide wire crosses the arterial location where the interventional procedure is to be performed, e.g. a lesion to be dilated or a dilated region where a stent is to be deployed. NOTE: As the disclosure references the use of the distal tip of the guidewire to position the dilation portion of a dilation catheter, the distal tip is interpreted as the dilation portion), wherein the plurality of second colorant regions are positioned in the dilation portion (Paragraph 0029-- The coating may include positional markers 36 at the distal or proximal end to aid the practitioner in locating the end portion(s) of the guide wire 10).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Nesbitt to include a dilation portion having the plurality of second colorant regions at the dilation portion as disclosed by Cornish in order to predictably improve the ability of the device to be used in locating particular portions of the medical device such as a balloon so that placement of particular areas of a medical device at a desired area of the human body may be accurately monitored and adjusted (see paragraph 0002 of Nesbitt).
Response to Arguments
Applicant's arguments filed 04 December 2025 have been fully considered but they are not persuasive.
While the applicant argues that Nesbitt “fails to disclose or suggest that the adhesive capability is chemically integrated into the fluororesin polymer chain itself”, Nesbitt discloses that the material of the coating may be PTFE or any suitable material, which can include any suitable binder or resin. Kamiya has additionally been cited to teach the newly amended limitations of claim 1.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791