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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 27 January 2026 has been entered.
The Examiner acknowledges the amendments to claim 1, the cancelation of claim 20, and the addition of new claim 21. Claims 1-19 and 21 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “23a” and “23b” [Fig. 7], “24a” and “24b” [Fig. 8].
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haruyama (US-20220395672-A1, previously presented) in view of Rikiya (JP-2015065986, previously presented, translation cited and attached by Applicant) and Uihlein (US-20110021951-A1, previously presented).
Regarding claim 1, Haruyama teaches
A guide wire comprising:
a core shaft having an elongated outer shape [wire body 2 (Haruyama Figs. 1-2)]; and
a coating film on an outer surface of the core shaft, the coating film containing a resin [The intermediate layer 3 is configured to cover the surface of the wire body 2 and is configured by a material including a pigment and a binder resin (Haruyama ¶0028, Figs. 1-4)], wherein
the coating film is in direct contact with the core shaft [Haruyama ¶0028, Figs. 1-4],
the coating film includes a marker portion that contains a pigment on an outer surface of the coating film and a resin portion of the coating film that does not contain the pigment [the intermediate layer may include a first region 31 including a first pigment and a second region 32 including a second pigment having a color different from that of the first pigment (Haruyama ¶0038), wherein if the first region 31 is taken to read on the marker portion and the second region 32 is taken to read on the resin portion, the second region 32 having a different pigment is considered to read on the resin portion not containing the same pigment as the marker portion],
on the outer surface of the coating film, the marker portion and the resin portion are alternately visible in a stretching direction [Haruyama Figs. 2-4],
a thickness in a direction orthogonal to the outer surface of the coating film where the marker portion is visible on the outer surface of the coating film is substantially the same or less than a thickness in the direction orthogonal to the outer surface of the coating film where the resin portion is visible on the outer surface of the coating film [However, as shown in an enlarged plan view in FIG. 3(a) and an enlarged cross-sectional view taken along line B-B of FIG. 3(a) in FIG. 3(b), the first region 31 and the second region 32 may be configured as a double spiral structure (a form in which a spiral pattern is formed by the intermediate layer 3 as a single layer) disposed alternately on the wire body 2 along the longitudinal direction of the wire body 2 (Haruyama ¶0041)].
However, while Haruyama discloses the use of different colors between the marker portion and the resin portion to provide visibility of the guide wire [In the intermediate layer 3 having the first region 31 and the second region 32 as described above, the above-described effect of improving the adhesion can be obtained by setting the concentration of the pigment included in the intermediate layer 3 (the concentration of the pigment obtained by adding the first pigment and the second pigment) to be 50 wt % or more and 90 wt % or less with respect to the intermediate layer 3 as a whole. Further, the first region 31 and the second region 32 having different colors from each other are provided, and thus a movement of the guidewire can be easily recognized through an endoscopic fiberscope. The medical guidewire shown in FIG. 2 therefore has excellent visibility (Haruyama ¶0040)], Haruyama fails to explicitly disclose wherein the resin portion does not contain any pigment.
Rikiya discloses an elongated instrument comprising a resin coating film [The material of the base material 4 covered with the surface lubricating layer 5 is not particularly limited and may be selected from a material normally used in catheter 100 as a medical device, and may be any of a polymer material (Rikiya ¶0024, Figure 1); The polymer material is not particularly limited, and known medical polymers can be used. Specifically, a polyolefin resin such as a polyethylene resin or a polypropylene resin such as a polyamide resin… is used (Rikiya ¶0025, Fig. 1)], wherein the coating film includes a marker portion that contains a pigment on an outer surface of the coating film and a resin portion that does not contain any pigment [The first surface lubricating layer 4 has a region 2 containing a relatively large amount of pigment at least in part and a region 3 containing a relatively small amount of dye (or a region containing no dye) (Rikiya ¶0028, Figs. 1-2); By forming such a pattern on the first surface lubricating layer 4, particularly, visibility can be improved (Rikiya ¶0029)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama to employ wherein the resin portion does not contain any pigment, as this modification would amount to mere simple substitution of one known element [contrasting visible pattern of the resin portion by using a different colored dye from the marker portion (Haruyama ¶0038)] for another [contrasting visible pattern of the resin portion by using no dye as compared to using dye in the marker portion (Rikiya ¶¶0028-0029)] with similar expected results [allow for visibility based on the contrasting visible pattern between the marker portion and the resin portion] [MPEP § 2143(I)(B)].
However, Haruyama in view of Rikiya fails to explicitly disclose that in a longitudinal section along a stretching direction of the core shaft, a cross-sectional width of the marker portion decreases toward an inside of the core shaft in a radial direction.
Uihlein discloses a guide wire comprising a core shaft with a coating film on an outer surface of the core shaft [the guide wire 1 contains a core wire 4, which is made of a material that is customary for this purpose, for example, a stainless steel or nitinol material, which is enveloped by a protective sheathing 5 (Uihlein ¶0052, Figure 1)], wherein the coating film includes a marker portion that is formed such that a cross-sectional width of the marker portion decreases toward an inside of the core shaft in a radial direction along a longitudinal section along a stretching direction of the elongate shaft [the longitudinal marking strip(s) is (are) integrated into a sheathing of a core wire of the guide wire by using a suitably detectable material for the sheathing in a peripheral area forming the longitudinal marking strip(s). In this case the material is different from the material(s) for the remaining area of the sheathing. This feature allows the longitudinal marking strip(s) to be produced in an advantageous way even from a manufacturing viewpoint, for example, when they are provided as radiographically detectable longitudinal strips (Uihlein ¶0016); the marking surfaces are formed by ring segment marking surfaces that are rectangular, diamond shaped, oval or circular in the circumferential development of the guide wire (Uihlein ¶0021), see semicircular-shaped marking 33 in Figure 1].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama in view of Rikiya to configure the marker portion such that the cross-sectional width of the marker portion decreases toward the inside of the core shaft in the radial direction along the longitudinal section along the stretching direction of the core shaft, as this modification would amount to mere simple substitution of one shape of a marker [first region 31 of Haruyama] for another [semicircular-shaped marking 33 in Uihlein Figure 1] with similar expected results [allowing for visualization of the marker] [MPEP § 2143(I)(B)].
Regarding claim 2, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein
the marker portion includes a first region including a central region of the marker portion and a second region provided around the first region, both the first region and the second region being on an outer surface of the marker portion [wherein any central portion of first region 31 may be considered to be a “first region” and any other portion about the central portion of first region 31 may be considered to be a “second region” (see Haruyama Figs. 3(a)-(b)],
both the first region and the second region contain pigment [Haruyama ¶0038], and
a content of the pigment contained in the second region is different than a content of the pigment contained in the first region [Haruyama ¶0038, wherein as no particular constraints are applied to the size of the first region and the second region, the second region may be interpreted to be a different size than the first region such that the content of the pigment contained in the second region is different from a content of the pigment contained in the first region].
Regarding claim 3, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 2, wherein the content of the pigment contained in the second region is smaller than the content of the pigment contained in the first region [Haruyama ¶0038].
Regarding claim 5, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 3, wherein a thickness of the first region of the marker portion is less than a thickness of the second region [wherein based on the Examiner’s note for claim 2 above, the first region may be considered to have a smaller thickness than the second region].
Regarding claim 6, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 2, wherein a thickness of the first region of the marker portion is less than a thickness of the second region [wherein based on the Examiner’s note for claim 2 above, the first region may be considered to have a smaller thickness than the second region].
Regarding claim 7, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 2.
However, while Haruyama is particular regarding the average particle size of the pigment contained in the marker portion [An average particle diameter of the pigment is not particularly limited, but is preferably set in a range of 0.05 μm or more and 2 μm or less, more preferably 0.1 μm or more and 1.5 μm or less (Haruyama ¶0028)], Haruyama is not particular regarding the average particle size of the resin, such that Haruyama in view of Rikiya and Uihlein fails to explicitly disclose wherein an average particle size of the pigment contained in the marker portion is smaller than an average particle size of the resin portion.
Haruyama does disclose different methods, as well as other methods not explicitly disclosed, may be used to apply the pigment to the marker portion [For example, the intermediate layer 3 can be formed by applying a solution prepared by mixing the pigment and the binder resin described above with an appropriate solvent to the wire body 2 and then drying the solution to volatilize the solvent. The material included in the intermediate layer 3 is not limited to the pigment and the binder resin described above, but may include, for example, a fluorine resin or various other additives (Haruyama ¶0032)].
Rikiya discloses a method for a resin film to absorb a dye [The first surface lubricating layer 4 may be made of any material as long as it absorbs water to exhibit lubricity and can sufficiently adsorb a dye to be described later. For example, hydrophilic giant molecules etc. are mentioned (Rikiya ¶0033), wherein it is understood for the layer 4 (resin) to absorb the dye (marker portion), the particle size of the marker portion would be smaller than the particle size of the resin].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama in view of Rikiya and Uihlein to employ wherein an average particle size of the pigment contained in the marker portion is smaller than an average particle size of the resin portion, as this modification would amount to mere application of a known technique [absorbing a dye as disclosed by Rikiya] to a known device (method, or product) ready for improvement to obtain predictable results [impart pigment onto the marker portion] [MPEP § 2143(I)(B)]. The Examiner notes that as the resin portion as presently modified contains no pigment, the average particle size of the pigment contained in the marker portion of the resin coating film is considered to be smaller than the average particle size of the resin portion.
Regarding claim 8, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1.
However, while Haruyama is particular regarding the average particle size of the pigment contained in the marker portion [Haruyama ¶0028], Haruyama is not particular regarding the average particle size of the resin, such that Haruyama in view of Rikiya and Uihlein fails to explicitly disclose wherein an average particle size of the pigment contained in the marker portion is smaller than an average particle size of the resin portion.
Haruyama does disclose different methods, as well as other methods not explicitly disclosed, may be used to apply the pigment to the marker portion [Haruyama ¶0032].
Rikiya discloses a method for a resin film to absorb a dye [Rikiya ¶0033, wherein it is understood for the layer 4 (resin) to absorb the dye (marker portion), the particle size of the marker portion would be smaller than the particle size of the resin].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama in view of Rikiya and Uihlein to employ wherein an average particle size of the pigment contained in the marker portion is smaller than an average particle size of the resin portion, as this modification would amount to mere application of a known technique [absorbing a dye as disclosed by Rikiya] to a known device (method, or product) ready for improvement to obtain predictable results [impart pigment onto the marker portion] [MPEP § 2143(I)(B)]. The Examiner notes that as the resin portion as presently modified contains no pigment, the average particle size of the pigment contained in the marker portion of the resin coating film is considered to be smaller than the average particle size of the resin portion.
Regarding claim 9, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein the marker portion is in direct contact with the core shaft [Haruyama ¶0028, Figs. 1-4].
Regarding claim 10, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein the marker portion is on only a portion of the coating film [Haruyama ¶0038, Figs. 2-4].
Regarding claim 11, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein a thickness of a portion of the marker portion on the outer surface is convex toward the core shaft in the radial direction [see § 103 modification of claim 1 above; see Uihlein Fig. 1].
Regarding claim 12, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 2, wherein the first region of the marker portion is not in direct contact with the resin portion [wherein the first region being a central region of first region 31 is considered to read on the claimed limitation given the configuration of the first region 31 relative to second region 32 as depicted in Haruyama Figs. 3(a)-(b)].
Regarding claim 13, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 2, wherein the second region of the marker portion is in direct contact with the resin portion [wherein the second region being about the central region of first region 31 is considered to read on the claimed limitation given the configuration of the first region 31 relative to second region 32 as depicted in Haruyama Fig. 3(a)-(b)].
Regarding claim 14, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 2, wherein the second region of the marker portion is in direct contact with the core shaft [Haruyama ¶0028, Figs. 3(a)-(b)].
Regarding claim 15, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein the core shaft is solid [The wire body 2 is a flexible and long linear member. The wire body 2 can be configured by various conventional materials used as a core material for a medical guidewire, but is preferably configured by a metal material (Haruyama ¶0019)].
Regarding claim 17, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein the outer surface of the marker portion and the outer surface of the resin portion are flush [Haruyama Figs. 3(a)-(b)].
Regarding claim 18, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein a thickness of at least a portion of the marker portion of the coating film is less than a thickness of the resin portion of the coating film [wherein any limited portion of the first region 31 may be considered to have a smaller thickness than the entirety of the second region 32].
Regarding claim 19, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1, wherein an outer surface of the marker portion is an arc [Haruyama Fig. 4(a), wherein the border between the first region 31 and the second region 32 is considered to define an arc].
Claim(s) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haruyama in view of Rikiya and Uihlein, as applied to claims 1 and 3 above, in further view of Murayama (US-20050027214-A1, previously presented).
Regarding claim 4, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 3.
However, Haruyama in view of Rikiya and Uihlein fails to explicitly disclose wherein the first region of the marker portion is not in direct contact with the resin portion.
Murayama discloses guide wires made from different materials, wherein Murayama discloses positioning an intermediate material between a first material and a second material when forming the guide wire, wherein the intermediate material is a mixture of the first material and the second material [Further, where the guide wire includes the intermediate portion located between the distal end portion and the main body portion and the intermediate portion includes the center layer formed of the first material and the surface layer formed of a mixture of the first material and the second material, the guide wire does not show an abrupt change in physical properties between the distal end portion and the main body portion. Therefore, the guide wire does not have a point or points of abrupt change in physical properties but shows good operationality (Murayama ¶0092); Furthermore, where the intermediate layer formed of a mixture of the first material and the second material is decreased in the content of the first material and increased in the content of the second material as the surface layer is approached, the guide wire has gradient physical properties in the radial direction, resulting in that inter-layer exfoliation and the like are prevented from occurring (Murayama ¶0093)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama in view of Rikiya and Uihlein to prevent direct contact between the first region of the marker portion and the resin portion by introducing an intermediate portion comprising a mixture of the materials of the marker portion and the resin portion between the marker portion and the resin portion to prevent abrupt changes in physical properties that may affect operability of the guidewire [Murayama ¶0093].
Regarding claim 16, Haruyama in view of Rikiya and Uihlein teaches
The guide wire according to claim 1.
However, Haruyama in view of Rikiya and Uihlein fails to explicitly disclose wherein the marker portion of the coating film is not in direct contact with the core shaft.
Murayama discloses guide wires made from different materials, wherein Murayama discloses positioning an intermediate material between a first material and a second material when forming the guide wire, wherein the intermediate material is a mixture of the first material and the second material [Murayama ¶¶0092-0093].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama in view of Rikiya and Uihlein to prevent direct contact between the first region of the marker portion and the resin portion by introducing an intermediate portion comprising a mixture of the materials of the marker portion and the resin portion between the marker portion and the resin portion to prevent abrupt changes in physical properties that may affect operability of the guidewire [Murayama ¶0093].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haruyama (US-20220395672-A1, previously presented) in view of Uihlein (US-20110021951-A1, previously presented).
Regarding claim 21, Haruyama teaches
A guide wire comprising:
a core shaft having an elongated outer shape [wire body 2 (Haruyama Figs. 1-2)]; and
a coating film on an outer surface of the core shaft, the coating film containing a resin [The intermediate layer 3 is configured to cover the surface of the wire body 2 and is configured by a material including a pigment and a binder resin (Haruyama ¶0028, Figs. 1-4)], wherein
the coating film is in direct contact with the core shaft [Haruyama ¶0028, Figs. 1-4],
the coating film includes a marker portion that contains a pigment on an outer surface of the coating film and a resin portion [the intermediate layer may include a first region 31 including a first pigment and a second region 32 including a second pigment having a color different from that of the first pigment (Haruyama ¶0038), wherein the first region 31 is taken to read on the marker portion and the second region 32 is taken to read on the resin portion],
on the outer surface of the coating film, the marker portion and the resin portion are alternately visible in a stretching direction [Haruyama Figs. 2-4],
a thickness in a direction orthogonal to the outer surface of the coating film where the marker portion is visible on the outer surface of the coating film is substantially the same or less than a thickness in the direction orthogonal to the outer surface of the coating film where the resin portion is visible on the outer surface of the coating film [However, as shown in an enlarged plan view in FIG. 3(a) and an enlarged cross-sectional view taken along line B-B of FIG. 3(a) in FIG. 3(b), the first region 31 and the second region 32 may be configured as a double spiral structure (a form in which a spiral pattern is formed by the intermediate layer 3 as a single layer) disposed alternately on the wire body 2 along the longitudinal direction of the wire body 2 (Haruyama ¶0041)].
However, while Haruyama depicts the marker portion and the resin portion as being side by side and defining a flush outer surface [Haruyama Figs. 3(a)-4(b)], Haruyama fails to explicitly disclose an adherence area between the marker portion and the resin portion is larger than a surface area of the marker portion on the outer surface of the coating film; and that in a longitudinal section along a stretching direction of the core shaft, a cross-sectional width of the marker portion decreases toward an inside of the core shaft in a radial direction.
Uihlein discloses a guide wire comprising a core shaft with a coating film on an outer surface of the core shaft [the guide wire 1 contains a core wire 4, which is made of a material that is customary for this purpose, for example, a stainless steel or nitinol material, which is enveloped by a protective sheathing 5 (Uihlein ¶0052, Figure 1)], wherein the coating film includes a marker portion that is formed such that a cross-sectional width of the marker portion decreases toward an inside of the core shaft in a radial direction along a longitudinal section along a stretching direction of the elongate shaft [the longitudinal marking strip(s) is (are) integrated into a sheathing of a core wire of the guide wire by using a suitably detectable material for the sheathing in a peripheral area forming the longitudinal marking strip(s). In this case the material is different from the material(s) for the remaining area of the sheathing. This feature allows the longitudinal marking strip(s) to be produced in an advantageous way even from a manufacturing viewpoint, for example, when they are provided as radiographically detectable longitudinal strips (Uihlein ¶0016); the marking surfaces are formed by ring segment marking surfaces that are rectangular, diamond shaped, oval or circular in the circumferential development of the guide wire (Uihlein ¶0021), see semicircular-shaped marking 33 in Fig. 1], wherein an adherence area between the marker portion and the coating film is larger than a surface area of the marker portion on the outer surface of the coating film [wherein the Examiner notes that as depicted in Uihlein Figs. 4-5, as the marking cross-sectional width decreases towards an inside of the core shaft in a radial direction, the marking has an outer surface area that is smaller than a surface area defining an adherence area between the marking and the sheathing 5].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the guide wire of Haruyama to employ wherein an adherence area between the marker portion and the resin portion is larger than a surface area of the marker portion on the outer surface of the coating film and configure the marker portion such that the cross-sectional width of the marker portion decreases toward the inside of the core shaft in the radial direction along the longitudinal section along the stretching direction of the core shaft, as this modification would amount to mere simple substitution of one shape of a marker [first region 31 of Haruyama] for another [semicircular-shaped marking 33 in Uihlein Figure 1] with similar expected results [allowing for visualization of the marker] [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8-9, filed 27 January 2026, with respect to the rejection(s) of claim(s) 1-3, 5-15, and 17-20 under § 103 as being unpatentable over Haruyama in view of Uihlein and claim(s) 4 and 16 under § 103 as being unpatentable over Haruyama in view of Uihlein and Murayama have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection of claim 1 is made in view of Haruyama (US-20220395672-A1, previously presented) in view of Rikiya (JP-2015065986, previously presented, translation cited and attached by Applicant) and Uihlein (US-20110021951-A1, previously presented).
The Applicant asserts that the amended portion of claim 1 wherein the resin portion of the coating film “does not contain any pigment” fails to be taught, disclosed, or suggested by the previously applied references of Haruyama, Uihlein, and Murayama, wherein the Applicant further notes that ¶0036 [The medical guidewire 1 according to the present embodiment is configured such that the intermediate layer 3 is interposed between the wire body 2 and the outermost layer 4 as described above, and the concentration of the pigment included in the intermediate layer 3 is 50 wt % or more and 90 wt % or less with respect to the intermediate layer 3 as a whole. Such a configuration can significantly enhance the adhesion between the outermost layer 4 and the intermediate layer 3, and can effectively prevent the outermost layer 4 from peeling off due to contact with the distal end of a hollow puncture needle, for example, when the guidewire 1 is used as a guide wire passed through the puncture needle in a ultrasonic endoscopic paracentesis] of Haruyama teaches away from a region having no pigment. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 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. Claim 1 is currently rejected as being obvious over Haruyama (US-20220395672-A1, previously presented) in view of Rikiya (JP-2015065986, previously presented, translation cited and attached by Applicant) and Uihlein (US-20110021951-A1, previously presented), wherein the Examiner notes that Rikiya discloses an elongated instrument comprising a resin coating film [The material of the base material 4 covered with the surface lubricating layer 5 is not particularly limited and may be selected from a material normally used in catheter 100 as a medical device, and may be any of a polymer material (Rikiya ¶0024, Figure 1); The polymer material is not particularly limited, and known medical polymers can be used. Specifically, a polyolefin resin such as a polyethylene resin or a polypropylene resin such as a polyamide resin… is used (Rikiya ¶0025, Fig. 1)], wherein the coating film includes a marker portion that contains a pigment on an outer surface of the coating film and a resin portion that does not contain any pigment [The first surface lubricating layer 4 has a region 2 containing a relatively large amount of pigment at least in part and a region 3 containing a relatively small amount of dye (or a region containing no dye) (Rikiya ¶0028, Figs. 1-2); By forming such a pattern on the first surface lubricating layer 4, particularly, visibility can be improved (Rikiya ¶0029)]. Furthermore, the Examiner disagrees with the Applicant’s argument that Haruyama teaches away from a region having no pigment, as Haruyama merely discloses that the intermediate layer as a whole [which is considered to be defined by both first region 31 and second region 32] has a concentration of pigment in a range of 50 wt % or more and 90 wt % or less [in which the intermediate layer is colored by including a pigment, and the pigment has a concentration of 50 wt % or more and 90 wt % or less with respect to the intermediate layer as a whole (Haruyama ¶0007); The material included in the intermediate layer 3 is not limited to the pigment and the binder resin described above, but may include, for example, a fluorine resin or various other additives (Haruyama ¶0032); In the intermediate layer 3 having the first region 31 and the second region 32 as described above, the above-described effect of improving the adhesion can be obtained by setting the concentration of the pigment included in the intermediate layer 3 (the concentration of the pigment obtained by adding the first pigment and the second pigment) to be 50 wt % or more and 90 wt % or less with respect to the intermediate layer 3 as a whole. Further, the first region 31 and the second region 32 having different colors from each other are provided, and thus a movement of the guidewire can be easily recognized through an endoscopic fiberscope. The medical guidewire shown in FIG. 2 therefore has excellent visibility (Haruyama ¶0040)], wherein the concentration of pigment in the intermediate layer as a whole is modifiable to affect adherence of the outermost layer 4 to the intermediate layer 3, as Haruyama notes that the binder resin is what affects the adhesion [Using such a material as the binder resin can effectively improve the adhesion between the wire body 2 and the outermost layer 4 (Haruyama ¶0029); Haruyama Table 2].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791