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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(S) because they include the following reference character(s) not mentioned in the description: Currently (Fig. 1) contains the reference character '100B', which is currently not found within the instant application's specifications. 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.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, ... wherein the heat shrink tubing shrinks when heated to constrain and solely apply pressure to the polymer jacket during reflowing of the polymer jacket to maintain the positioning and distribution of the polymer jacket around ... must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered, and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claim(s) 1 – 20 is /are objected to because of the following informalities:
Currently, claim(s) 1, 11 & 19 currently read “…wherein the heat shrink tubing shrinks when heated to constrain and solely apply pressure to the polymer…” they should read “…wherein the heat shrink tubing shrinks when heated to constrain and solely applies pressure to the polymer…” for the purpose of grammatical clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-10 & 21-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Currently, claim 1, 21 & 29 have been amended to recite ... wherein the heat shrink tubing shrinks when heated to constrain and solely apply pressure to the polymer jacket during ref/owing of the polymer jacket to maintain the positioning and distribution of the polymer jacket around ... Currently, this newly amended limitation was not found in the specification nor was it found in the figures. Presently, it seems that (Fig. 6C) depicts the opposite of the newly amended limitation.
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.
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.
A.) Claim(s) 1 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharrow et al. (US 20070299366 A1, hereinafter Sharrow)Regarding claim 1,
A method of making a guidewire, the method comprising:
placing a polymer jacket over a core wire,
the core wire including a length including a first portion having a first thickness and
a second portion having a second thickness,
the first thickness being smaller than the second thickness;
placing heat shrink tubing over the polymer jacket; and
applying heat to the polymer jacket, the heat shrink tubing, and the core wire to reflow the polymer jacket and fuse the polymer jacket to the core wire,
wherein the heat shrink tubing shrinks when heated to constrain and solely apply pressure to the polymer jacket during reflowing of the polymer jacket to maintain the positioning and distribution of the polymer jacket around and in proximity to the core wire with application of the heat to the polymer jacket, the heat shrink tubing, and the core wire,
such that the polymer jacket forms a layer of a polymer material of substantially uniform thickness along the length of the core wire, thereby substantially following a shape of the core wire.
Sharrow teaches the following:
(Abstract) teaches that the guidewire may include a core wire, and a polymer jacket attached to the core wire. The guidewire may be manufactured by advancing the core wire, polymer jacket, and a tooling tube through a heated die assembly so as to heat and compress the polymer jacket onto the core wire.
, c.) & d.) ([0027]) teaches that the core wire 22 can have any of a broad variety of cross-sectional shapes, for example, round, flattened, oval, rectangular, square, polygonal, and the like, or any other suitable shape. The cross-sectional shape can be constant or can vary. The core wire 22 may have a generally constant outer diameter or may include one or more tapers and/or tapered regions, which may be linearly tapered, tapered in a curvilinear fashion, uniformly tapered, non-uniformly tapered, or tapered in a step-wise fashion.
([0026]) teaches that as can be seen in FIG. 3, a core wire 22, a polymer jacket member 24 a, and an additional member, such as an elongated tubular member 26 can be provided, for example, as three separate members. ([0050]} teaches that the elongated tubular member 26 may be made from a fluorocarbon material, such as PTFE, FEP, PFA, CTFE, ETFE, or the like (including heat. shrink varieties thereof) or may otherwise include a fluorocarbon. For example, an elongated PTFE tube may be used as the elongated tubular member 26.
([0056]) teaches that as the heat is transferred into the polymer jacket member 24, the polymer jacket member 24 is heated such that it softens, becomes viscoelastic, and/or melts (minimally, completely, or anywhere there between). For example, the heat applied can be sufficient to heat the polymer jacket member 24 to its softening point temperature or above.
([0047]) teaches when heated to temperatures that. are needed to heat. the polymer jacket member 24 a to the softening point temperature, the material of the elongated tubular member 26 may be less viscoelastic, less plastic and/or more viscous than the material of the polymer jacket member 24 a. As such, the elongated tubular member 26 can thereby function as an outer barrier and/or forming member and/or retaining member and/or tooling member for the polymer jacket member 26 while not melting with or into the polymer jacket member 26. ([0042J) adding that a predetermined amount of heat is applied to the outer surface 39, the elongated tubular member 26 can transfer at least some of this heat to the polymer jacket member 24 a-thereby allowing the heat to soften the material of the polymer jacket member 24 a. Additionally, the elongated tubular member 26 can be adapted and/or configured such that when a predetermined compressive force is applied to the outer surface 39, the elongated tubular member 26 can transfer at least some of this compressive force to the polymer jacket member 24 o. As such, the heat and pressure of the elongated tubular member is understood to be applied and transferred to the polymer jacket member 24. Additionally, ([0051]) teaches the entire length of the
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elongated tubular member 26 can be disposed about a portion of polymer jacket member 24 a and/or core wire 22. However, in other embodiments, the elongated tubular member 26 can be disposed such that it includes a first portion 70 that is disposed about. a portion of polymer jacket member 24 a and/or the core wire 22, and a second portion 72 that extends beyond, and is not disposed polymer jacket member 24 a and/or the core wire 22. Furthermore, ([0028]) teaches that the polymer jacket can cover the whole length of the tube and extending beyond the distal or proximal end of the tube. As such, there is a case during molding that the subassembly is only covering a portion of polymer jacket that extends beyond the core (see Fig, 4).
([0024]) teaches that the polymer jacket 24 may extend over the entire length of the core wire 22, may extend only about a portion of the distal and/or proximal portions 29/31, may or may not be disposed such that it begins or ends relative to any tapers or constant diameter portions of the core wire 22, or may include any thickness or outer diameter that is deemed to be desired or useful. Additionally, the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. ([0024]) adding that the outer diameter of the polymer jacket. 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transition. Additionally, the case law for change of shape may be recited. Where, the court held that the configuration of the claimed container was found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, see In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et al., 3 USPQ 23.
Regarding claim 2 – 4, 6 & 9 – 10 as applied to claim 1 & 9 respectively,
Wherein applying the heat to the polymer jacket and the core wire includes fusing the polymer jacket to the core wire such that a first profile of the polymer jacket and the core wire at the first portion of the core wire is smaller than a second profile of the polymer jacket and the core wire at the second portion of the core wire.
Wherein placing the polymer jacket over the core wire includes the first portion of the core wire being proximate a distal end of the core wire.
Wherein placing the polymer jacket over the core wire includes the second portion of the core wire being disposed between the first portion and a proximal end of the core wire.
Wherein placing the polymer jacket over the core wire includes the core wire having a tapered portion between the first portion and the second portion.
Wherein applying heat to the polymer jacket and the core wire includes reflowing the polymer jacket to form the layer of substantially uniform thickness along the first portion of the core wire.
Wherein applying heat to the polymer jacket and the core wire includes achieving the layer of substantially uniform thickness along the first portion of the core wire without trimming down the polymer jacket.
Sharrow teaches the following:
, 3a.), 4a.), 6a.), 9a.) & 10a.) ([0024]) teaches that a polymer member, such as a thermoplastic polymer jacket 24, is connected about a portion of the core wire 22. The polymer jacket 24 includes an outer surface 25 and an inner surface 27. ([0024]} teaches that the polymer jacket 24 may extend over the entire length of the core wire 22, may extend only about a portion of the distal and/or proximal portions 29/31 .. may or may not be disposed such that it begins or ends relative to any tapers or constant diameter portions of the core wire 22 or may include any thickness or outer diameter that is deemed to be desired or useful. Additionally, the outer diameter of the polymer jacket 24 may be constant. or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. Highlighting (Figs. 2 & 8) give some visual depictions of the polymer jacket and core wire.
Regarding claim 5 as applied to claim 1,
Further comprising
removing the heat shrink tubing from the polymer jacket and the core wire after applying the heat to the polymer jacket and the core wire.
Sharrow teaches the following:
([0065]) teaches that the elongated tubular member 26 can be removed so that a guidewire 10 including a core wire 22 and a plastic jacket 24 attached about a portion of the core wire 22 is formed, for example, as shown in FIG. 2. For example, the elongated tubular member 26 can be removed by pulling, stripping, cutting, grinding, or otherwise removing the elongated tubular member 26 from about the outer surface 25 of the polymer jacket 24.
Regarding claim 7 – 8 as applied to claim 1 and claim 8 respectively,
Further comprising
placing a coil over the core wire, wherein the coil is disposed completely within the polymer jacket after the polymer jacket is reflowed.
Wherein placing the coil over the core wire includes placing the coil over the first portion of the core wire.
Sharrow teaches the following:
([0029]) teaches that a number of additional structures may be embedded within polymer jacket 24 such as a coil, braid, and the like. ([0069]) expanding this by teaching that the guidewire may also include one or more coils, such as inner coils, outer coils, spring coils or marker coils, ribbons or wires, such as shaping or safety ribbons or wires; bands or rings, such as markers or centering bands or rings; additional coatings or polymer layers; and/or any of a broad variety of other structures generally known. Such structures may be disposed over, underneath, or encapsulated within the polymer jacket 24, or may be disposed over, about or on the core wire 22 at a location adjacent to or separate from the polymer jacket 24.
Regarding claim 11,
A method of making a guidewire, the method comprising:
placing a polymer jacket over a core wire,
the core wire including a length including a first portion having a first thickness and
a second portion having a second thickness,
the first thickness being smaller than the second thickness;
placing heat shrink tubing over the polymer jacket; and
applying heat to the polymer jacket, the heat shrink tubing, and the core wire to reflow the polymer jacket and fuse the polymer jacket to the core wire,
wherein the heat shrink tubing shrinks when heated to constrain and solely apply pressure to the polymer jacket during reflowing of the polymer jacket to maintain the positioning and distribution of the polymer jacket around and in proximity to the core wire with application of the heat to the polymer jacket, the heat shrink tubing, and the core wire,
such that a first profile of the polymer jacket and the core wire at the first portion of the core wire is smaller than a second profile of the polymer jacket and the core wire at the second portion of the core wire,
wherein the polymer jacket forms a layer of a polymer material of substantially uniform thickness along the length of the core wire, thereby substantially following a shape of the core wire.
Sharrow teaches the following:
(Abstract) teaches that the guidewire may include a core wire, and a polymer jacket attached to the core wire. The guidewire may be manufactured by advancing the core wire, polymer jacket, and a tooling tube through a heated die assembly so as to heat and compress the polymer jacket onto the core wire.
, c.) & d.) ([0027]) teaches that the core wire 22 can have any of a broad variety of cross--sectional shapes, for example, round, flattened, oval, rectangular, square, polygonal, and the like, or any other suitable shape. The cross-sectional shape can be constant or can vary. The core wire 22 may have a generally constant outer diameter or may include one or more tapers and/or tapered regions, which may be linearly tapered, tapered in a curvilinear fashion, uniformly tapered, non-uniformly tapered, or tapered in a step-wise fashion.
([0026]) teaches that as can be seen in FIG. 3, a core wire 22, a polymer jacket member 24 a, and an additional member, such as an elongated tubular member 26 can be provided, for example, as three separate members. ([0050]) teaches that the elongated tubular member 26 may be made from a fluorocarbon material, such as PTFE, FEP, PFA, CTFE, ETFE, or the like (including heat shrink varieties thereof}, or may otherwise include a fluorocarbon. For example, an elongated PTFE tube may be used as the elongated tubular member 26.
([0056]) teaches that as the heat is transferred into the polymer jacket member 24, the polymer jacket member 24 is heated such that it softens, becomes viscoelastic, and/or melts (minimally, completely, or anywhere there between). For example, the heat applied can be sufficient to heat the polymer jacket member 24 to its softening point temperature or above.
([0047]) teaches when heated to temperatures that. are needed to heat. the polymer jacket member 24 a to the softening point temperature, the material of the elongated tubular member 26 may be less viscoelastic, less plastic and/or more viscous than the material of the polymer jacket member 24 a, As such, the elongated tubular member 26 can thereby function as an outer barrier and/or forming member and/or retaining member and/or tooling member for the polymer jacket. member 26 while not melting with or into the polymer jacket member 26. ([0042]) adding that a predetermined amount of heat is applied to the outer surface 39, the elongated tubular member 26 can transfer at least some of this heat to the polymer jacket member 24 a-thereby allowing the heat to soften the material of the polymer jacket member 24 a. Additionally, the elongated tubular member 26 can be adapted and/or configured such that when a predetermined compressive force is applied to the outer surface 39, the elongated tubular member 26 can transfer at least some of this compressive force to the polymer jacket member 24 a. As such, the heat and pressure of the elongated tubular member is understood to be applied and transferred to the polymer jacket member 24. Furthermore, ([0051]) teaches the entire length of the elongated tubular member 26 can be disposed about a portion of polymer jacket member 24 a and/or core wire 22. However, in other embodiments, the elongated tubular member 26 can be disposed such that it includes a first portion 70 that is disposed about a portion of polymer jacket member 24 a and/or the core wire 22, and a second portion 72 that extends beyond, and is not disposed polymer jacket member 24 a and/or the core wire 22. Furthermore, ([0028]) teaches that the polymer jacket. can cover the whole length of the tube and extending beyond the distal or proximal end of the tube. As such, there is a case during molding that the subassembly is only covering a portion of polymer jacket that extends beyond the core (see Fig. 4).
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([0024]) teaches that the polymer jacket 24 may extend over the entire length of the core wire 22, may extend only about a portion of the distal and/or proximal portions 29/31, may or may not be disposed such that it begins or ends relative to any tapers or constant diameter portions of the core wire 22, or may include any thickness or outer diameter that is deemed to be desired or useful. Additionally, the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. ([0024]) adding that the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. Additionally, the case law for change of shape may be recited. Where, the court held that the configuration of the claimed container was found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, see In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et al., 3 USPQ 23.
Regarding claim 12 – 14 & 16 as applied to claim 11,
Wherein applying heat to the polymer jacket and the core wire includes achieving the layer of substantially uniform thickness along the first portion of the core wire without trimming down the polymer jacket.
Wherein placing the polymer jacket over the core wire includes the first portion of the core wire being proximate a distal end of the core wire.
Wherein placing the polymer jacket over the core wire includes the second portion of the core wire being disposed between the first portion and a proximal end of the core wire.
Wherein placing the polymer jacket over the core wire includes the core wire having a tapered portion between the first portion and the second portion.
Sharrow teaches the following:
, 13a.), 14a.) & 16a.) ([0024]) teaches that a polymer member, such as a thermoplastic polymer jacket 24, is connected about a portion of the core wire 22. The polymer jacket 24 includes an outer surface 25 and an inner surface 27, {[0024]} teaches that the polymer jacket 24 may extend over the entire length of the core wire 22, may extend only about a portion of the distal and/or proximal portions 29/31, may or may not be disposed such that it begins or ends relative to any tapers or constant diameter portions of the core wire 22, or may include any thickness or outer diameter that is deemed to be desired or useful. Additionally, the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. Highlighting (Figs. 2 & 8) give some visual depictions of the polymer jacket and core wire. Adding, that Sharrow does not teach or mention trimming down of the polymer jacket, as such there is no reason or motivation to do so.
Regarding claim 15 as applied to claim 11,
Further comprising
removing the heat shrink tubing from the polymer jacket and the core wire after applying the heat to the polymer jacket, the heat shrink tubing, and the core wire.
Sharrow teaches the following:
([0065]) teaches that the elongated tubular member 26 can be removed so that a guidewire 10 including a core wire 22 and a plastic jacket 24 attached about a portion of the core wire 22 is formed, for example, as shown in FIG. 2. For example, the elongated tubular member 26 can be removed by pulling, stripping, cutting, grinding, or otherwise removing the elongated tubular member 26 from about the outer surface 25 of the polymer jacket 24.
Regarding claim 17 – 18 as applied to claim 11 and claim 17 respectively,
Further comprising
placing a coil over the core wire, wherein the coil is disposed completely within the polymer jacket after the polymer jacket is reflowed.
Wherein placing the coil over the core wire includes placing the coil over the first portion of the core wire.
Sharrow teaches the following:
& 18a.) ([0029]) teaches that a number of additional structures may be embedded within polymer jacket 24 such as a coil, braid, and the like. {[0069J) expanding this by teaching that the guidewire may also include one or more coils, such as inner coils, outer coils, spring coils or marker coils, ribbons or wires, such as shaping or safety ribbons or wires; bands or rings, such as markers or centering bands or rings; additional coatings or polymer layers; and/or any of a broad variety of other structures generally known. Such structures may be disposed over, underneath, or encapsulated within the polymer jacket 24, or may be disposed over, about or on the core wire 22 at a location adjacent to or separate from the polymer jacket 24.
Regarding claim 19,
A method of making a guidewire, the method comprising:
placing a polymer jacket over a core wire,
the core wire including a length including a first portion having a first thickness and
a second portion having a second thickness,
the first thickness being smaller than the second thickness,
the first portion of the core wire being proximate a distal end of the core wire,
the second portion of the core wire being disposed between the first portion and a proximal end of the core wire;
placing heat shrink tubing over the polymer jacket; and
applying heat to the polymer jacket, the heat shrink tubing, and the core wire to reflow the polymer jacket and fuse the polymer jacket to the core wire,
wherein the heat shrink tubing shrinks when heated to constrain and solely apply pressure to the polymer jacket during reflowing of the polymer jacket to maintain the positioning and distribution of the polymer jacket around and in proximity to the core wire with application of the heat to the polymer jacket, the heat shrink tubing, and the core wire,
such that a first profile of the polymer jacket and the core wire at the first portion of the core wire is smaller than a second profile of the polymer jacket and the core wire at the second portion of the core wire,
the first profile including a thickness of less than 0.014 inches,
wherein the polymer jacket forms a layer of a polymer material of substantially uniform thickness along the length of the core wire without trimming down the polymer jacket, thereby substantially following a shape of the core wire.
Sharrow teaches the following:
(Abstract) teaches that the guidewire may include a core wire, and a polymer jacket attached to the core wire. The guidewire may be manufactured by advancing the core wire, polymer jacket, and a tooling tube through a heated die assembly so as to heat and compress the polymer jacket onto the core wire.
, c.) & d.) ([0027]) teaches that the core wire 22 can have any of a broad variety of cross--sectional shapes, for example, round, flattened, oval, rectangular, square, polygonal, and the like, or any other suitable shape. The cross-sectional shape can be constant or can vary. The core wire 22 may have a generally constant outer diameter or may include one or more tapers and/or tapered regions, which may be linearly tapered, tapered in a curvilinear fashion, uniformly tapered, non-uniformly tapered, or tapered in a step-wise fashion.
& f.) ([0026]) teaches that as can be seen in FIG. 3, a core wire 22, a polymer jacket member 24 a, and an additional member, such as an elongated tubular member 26 can be provided, for example, as three separate members. {[0050]) teaches that the elongated tubular member 26 may be made from a fluorocarbon material, such as PTFE, FEP, PFA, CTFE, ETFE, or the like (including heat shrink varieties thereof}, or may otherwise include a fluorocarbon. For example, an elongated PTFE tube may be used as the elongated tubular member 26. As illustrated in (Figs. 1 & 3), the first portion of the core wire being proximate a distal end of the core wire, and the second portion of the core wire being disposed between the first portion and a proximal end of the core wire.
([0056]) teaches that as the heat is transferred into the polymer jacket member 24, the polymer jacket member 24 is heated such that it softens, becomes viscoelastic, and/or melts (minimally, completely, or anywhere there between). For example, the heat applied can be sufficient to heat the polymer jacket member 24 to its softening point temperature or above.
([0047]) teaches when heated to temperatures that. are needed to heat. the polymer jacket member 24 a to the softening point temperature, the material of the elongated tubular member 26 may be less viscoelastic, less plastic and/or more viscous than the material of the polymer jacket member 24 a, As such, the elongated tubular member 26 can thereby function as an outer barrier and/or forming member and/or retaining member and/or tooling member for the polymer jacket member 26 while not melting with or into the polymer jacket member 26. ([0042]) adding that a predetermined amount of heat is applied to the outer surface 39, the elongated tubular member 26 can transfer at least some of this heat to the polymer jacket member 24 a thereby allowing the heat to softens the material of the polymer jacket member 24 a. Additionally, the elongated tubular member 26 can be adapted and/or configured such that when a predetermined compressive force is applied to the outer surface 39, the elongated tubular member 26 can transfer at least some of this compressive force to the polymer jacket member 24 a. As such, the heat and pressure of the elongated tubular member is understood to be applied and transferred to the polymer jacket member 24 a. Additionally, ([0051]) teaches the entire length of the elongated tubular member 26 can be disposed about a portion of polymer jacket member 24 a and/or core wire 22. However, in other embodiments, the elongated tubular member 26 can be disposed such that it includes a first portion 70 that is disposed about a portion of polymer jacket member 24 a and/or the core wire 22, and a second portion 72 that extends beyond, and is not disposed polymer jacket member 24 a and/or the core wire 22. Furthermore, ([0028]) teaches that the polymer jacket. can cover the whole length of the tube and extending beyond the distal or proximal end of the tube. As such, there is a case during molding that the subassembly is only covering a portion of polymer jacket that extends beyond the core (see Fig. 4).
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([0024]) teaches that the polymer jacket 24 may extend over the entire length of the core wire 22, may extend only about a portion of the distal and/or proximal portions 29/31, may or may not be disposed such that it begins or ends relative to any tapers or constant diameter portions of the core wire 22, or may include any thickness or outer diameter that is deemed to be desired or useful. Additionally, the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. ([0024]) adding that the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. Additionally, the case law for change of shape may be recited. Where, the court held that the configuration of the claimed container was found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, see In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et al., 3 USPQ 23.
, k.) & l.) ([0024]) teaches that the polymer jacket 24 may extend over the entire length of the core wire 22, may extend only about a portion of the distal and/or proximal portions 29/31, may or may not be disposed such that it begins or ends relative to any tapers or constant diameter portions of the core wire 22, or may include any thickness or outer diameter that is deemed to be desired or useful. Additionally, the outer diameter of the polymer jacket 24 may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions. ([0024]) adding that the outer diameter of the polymer jacket 24 a may be constant or tapered and may or may not mate up or be sized relative to portions of the core wire 22 to provide for smooth transitions, ([0031]) teaches that the polymer jacket member 24 a can be a generally tubular member having an outer diameter in the range of about 0.0015 to about 0.05 inches. Where an outer diameter in the range of about 0.0015 to about 0.05 inches is understood to overlap with applicant’s range of the first profile including a thickness of less than 0.014 inches. Additionally, the case law for change of shape or size may be recited. Where, the court held that the configuration of the claimed container was found obvious absent persuasive evidence that the particular configuration of the claimed container was significant, see In re Dailey et al., 149 USPQ 47; Eskimo Pie Corp. v, Levous et al., 3 USPQ 23.
Regarding claim 20 as applied to claim ,
Further comprising:
placing a coil over the first portion of the core wire,
wherein the coil is disposed completely within the polymer jacket after the polymer jacket is reflowed; and
removing the heat shrink tubing from the polymer jacket and the core wire after applying the heat to the polymer jacket, the heat shrink tubing, and the core wire.
Sharrow teaches the following:
& b.) ([0029]) teaches that a number of additional structures may be embedded Page 24 within polymer jacket 24 such as a coil, braid, and the like. {[0069]) expanding this by teaching that the guidewire may also include one or more coils, such as inner coils, outer coils, spring coils or marker coils; ribbons or wires, such as shaping or safety ribbons or wires; bands or rings, such as markers or centering bands or rings; additional coatings or polymer layers and/or any of a broad variety of other structures generally known. Such structures may be disposed over, underneath, or encapsulated within the polymer jacket 24, or may be disposed over, about or on the core wire 22 at a location adjacent to or separate from the polymer jacket 24.
([0065]) teaches that the elongated tubular member 26 can be removed so that a guidewire 10 including a core wire 22 and a plastic jacket 24 attached about a portion of the core wire 22 is formed, for example, as shown in FIG. 2. For example, the elongated tubular member 26 can be removed by pulling, stripping, cutting, grinding, or otherwise removing the elongated tubular member 26 from about the outer surface 25 of the polymer jacket
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reynolds et al. (US 20050096665 A1) - teaches in the (Abstract) a guidewire having a contoured outer surface and methods of making and using the same. The guidewire may include a core wire or member, and a jacket disposed over the core member. The jacket may include a contoured outer surface or helically-oriented channel, or groove formed therein.
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/Andrés E. Behrens Jr./Examiner, Art Unit 1741
/JaMel M Nelson/Primary Examiner, Art Unit 1743
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