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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on May 14th, 2026 is acknowledged. The traversal is on the ground(s) that the amended claims share the technical feature and therefore share unity of invention and Tran has not been applied to the claims as amended. This is found persuasive and therefore the restriction requirement has been withdrawn. In Applicant’s response, amended claims 1-21 are provided, however, the restriction requirement was between claims 1-23. Claims 22 & 23 are considered as still pending and as depending off of claim 21.
Information Disclosure Statement
The information disclosure statement (IDS) submitted September 24th, 2024 has been considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19 & 22 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 19, the claim recites “The method of claim 1” in line 1 and it is unclear which claim this claim is dependent upon since claim 1 is an apparatus claim. For examination purposes, the limitation will be interpreted as “The method of claim 14” until Applicant either amends or clarifies.
Regarding claim 22, the claim recites “a respective electrode” in line 2 and it is unclear if this electrode is the same electrode as the plurality of electrodes recited in claim 21, from which claim 22 depends or is a different electrode. For examination purposes, these are the same electrodes and the limitation will be interpreted as “a respective electrode of the plurality of electrodes”.
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.
Claims 1, 5-7, 9-10, 12-14, 16-17, 20-21 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (U.S. Pub. No. 20150209104, cited in IDS), herein referred to as “Tran” in view of Leung et al. (U.S. Pub. No. 20170071667), herein referred to as “Leung”.
Regarding claim 1, Tran discloses a catheter comprising a neuromodulation element (Abstract: A neuromodulation catheter), the neuromodulation element comprising:
an elongate structure (elongate shaft 108) defining a longitudinal axis (see axis in Fig. 1), wherein the elongate structure includes an outer jacket (distal jacket 200) comprising a polymer ([0035]: Suitable materials for the distal jacket 200 include polymer blends including polyurethane and polysiloxane, among others; [0033]: The distal jacket 200, for example, can be used in the neuromodulation element 112 (FIGS. 1, 2 and 6) in place of the distal jacket 144 (FIGS. 2 and 6)), and wherein the outer jacket defines an exterior surface of the elongate structure (see Figs. 1 & 10); and
at least one electrode (electrodes 204a-204d) configured to emit energy from an active area ([0025]: console 104 can be configured to generate radio frequency (RF) energy (e.g., monopolar and/or bipolar RF energy) and/or another suitable type of energy for delivery to tissue at a treatment location via electrodes (not shown) of the neuromodulation element 112),
wherein the elongate structure mechanically supports the at least one electrode such that the exterior surface and the active area face outward from the longitudinal axis (see Figs. 1 & 10 where the electrodes 204 are supported on jacket 200 and face outward), and wherein the catheter defines a material boundary (boundary defined by reduced-diameter segment 202), the material boundary adjoining the outer jacket and the at least one electrode ([0034]: The reduced-diameter segments 202 can be insets, pockets, grooves, or other suitable features configured to respectively seat the band electrodes 204), wherein the material boundary enables a mechanical adhesion between the polymer and the at least one electrode ([0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; [0034]; The reduced-diameter segments 202 can be insets, pockets, grooves, or other suitable features configured to respectively seat the band electrodes 204).
But Tran fails to disclose a material boundary formed by reflowing the polymer.
However, Leung discloses a material boundary formed by reflowing the polymer ([0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the material boundary formation process of Tran to be reflow, as taught by Leung, for the purpose of the reflow process enabling the polymer to flow around and encapsulate other features (Leung; [0048]).
Additionally, the recitation of “a material boundary formed by reflowing the polymer” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 5, Tran discloses wherein the elongate structure mechanically supports the at least one electrode such that the active area faces outward from a central axis defined by the neuromodulation element when the neuromodulation element is in a radially expanded deployed configuration ([0033]: The distal jacket 200, for example, can be used in the neuromodulation element 112 (FIGS. 1, 2 and 6) in place of the distal jacket 144 (FIGS. 2 and 6). Accordingly, the distal jacket 200 may be described below in conjunction with components of the catheter 102 (FIGS. 1 and 2) … FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; [0031]: In FIGS. 2 and 6, the neuromodulation element 112 is shown in a radially expanded deployed state. The neuromodulation element 112 can be movable from a low-profile delivery state to the radially expanded deployed state).
Regarding claim 6, Tran discloses wherein the at least one electrode comprises a band electrode extending circumferentially around the longitudinal axis ([0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202).
Regarding claim 7, Tran discloses wherein the elongate structure defines one or more reduced-diameter segments spaced longitudinally apart along the longitudinal axis of the elongate structure, and wherein the at least one electrode is seated in a reduced-diameter segment of the one or more reduced-diameter segments (reduced diameter segments 202; [0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202).
Regarding claim 9, Tran discloses wherein the neuromodulation element is convertible between a low-profile delivery configuration and a radially expanded deployed configuration, and wherein the elongate structure is configured to have a substantially linear shape when the neuromodulation element is in the low-profile delivery configuration and configured to have a substantially helical shape when the neuromodulation element is in the radially expanded deployed configuration ([0031]: In FIGS. 2 and 6, the neuromodulation element 112 is shown in a radially expanded deployed state. The neuromodulation element 112 can be movable from a low-profile delivery state to the radially expanded deployed state. When the neuromodulation element 112 is in the radially expanded deployed state, the distal hypotube segment 142 can have a shape that is more helical (spiral) than its shape when the neuromodulation element 112 is in the low-profile delivery state; [0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; wherein Fig. 11 is seen as the low-profile delivery state & Fig. 6 is seen as the radially expanded state).
Regarding claim 10, Tran discloses an electrical lead ([0034]: electrical leads (not shown)) electrically coupled to the at least one electrode ([0034]: electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200); and
a slot (openings 206) defining a passage from an inner lumen of the outer jacket to the at least one electrode when the elongate structure mechanically supports the at least one electrode ([0034]: distal jacket 200 can include openings 206 respectively positioned at the reduced-diameter segments 202 … electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200),
wherein the electrical lead extends through the inner lumen, and wherein the electrical lead extends through the slot ([0034]: A neuromodulation catheter including the distal jacket 200 can include electrical leads (not shown) extending from respective reduced-diameter segments 202, through respective openings 206, through a lumen of the distal hypotube segment 142 (FIGS. 2 and 6), through the intermediate tube 140, and through the proximal hypotube segment 128 to the handle 110. In this way, the electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200).
Regarding claim 12, Tran discloses wherein the outer jacket (distal jacket 200) defines a first cross-sectional dimension substantially perpendicular to the longitudinal axis (thickness of rim 212, Figs. 17 & 18) and the at least one electrode defines a second cross-sectional dimension substantially perpendicular to the longitudinal axis (see thickness of electrode 204a in Fig. 17), wherein the second cross-sectional dimension is greater than the first cross- sectional dimension (see Fig. 17 where the thickness of rim 212 is thinner than the thickness of the electrode 204a in Fig. 17).
Regarding claim 13, Tran discloses wherein the outer jacket defines a transition section adjacent the at least one electrode, wherein the transition section defines a cross-sectional dimension at least equal to the second cross-sectional dimension ([0036]: A maximum outer diameter of the band electrodes 204 and the maximum outer diameter of the distal jacket 200 between the reduced-diameter segments 202 can be at least generally equal (e.g., within 5%, 3%, or 2% of one another). Thus, once the band electrodes 204 are respectively seated in the reduced-diameter segments 202, outer surfaces of the band electrodes 204 and the distal jacket 200 between the reduced-diameter segments 202 can be at least generally flush; wherein the electrode being flush is seen as a transition section defining a cross sectional dimension that is at least equal to the second cross-sectional dimension since the claim does not define the boundaries of the transition section or what portion of the outer jacket that the transition section defines).
Regarding claim 14, Tran discloses a method ([0021]: a method for making a neuromodulation element) comprising:
forming an elongate structure (elongate structure 108) defining a longitudinal axis (see axis in Fig. 1), wherein the elongate structure includes an outer jacket (distal jacket 200) comprising a polymer ([0035]: Suitable materials for the distal jacket 200 include polymer blends including polyurethane and polysiloxane, among others; [0033]: The distal jacket 200, for example, can be used in the neuromodulation element 112 (FIGS. 1, 2 and 6) in place of the distal jacket 144 (FIGS. 2 and 6)), and wherein the outer jacket defines an exterior surface of the elongate structure (see Figs. 1 & 10);
mechanically supporting, using the elongate structure, at least one electrode (electrodes 204a-204d) configured to emit energy from an active area such that the exterior surface and the active area face outward from the longitudinal axis ([0025]: console 104 can be configured to generate radio frequency (RF) energy (e.g., monopolar and/or bipolar RF energy) and/or another suitable type of energy for delivery to tissue at a treatment location via electrodes (not shown) of the neuromodulation element 112; [0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; [0034]; The reduced-diameter segments 202 can be insets, pockets, grooves, or other suitable features configured to respectively seat the band electrodes 204), and
forming the polymer to define a material boundary adjoining the outer jacket and the at least one electrode, wherein the material boundary enables a mechanical adhesion between the polymer and the at least one electrode ([0040]: forming a tubular blank (block 502) (e.g., by extrusion) and then using a subtractive process (e.g., by laser ablation) to remove portions of the blank and thereby form the reduced-diameter segments 202 (block 504). The same or a different subtractive process can be used to form the openings 206 (block 506). Alternatively, the distal jacket 200 can be formed by injection molding or another suitable technique that allows the reduced-diameter segments 202 and/or the openings 206 to be formed without the need for a subtractive process; [0041]: the method 500 can include positioning the band electrode 204d (block 514) at the reduced-diameter segment 202d … the band electrode 204d is aligned with the reduced-diameter segment 202d).
but Tran fails to disclose reflowing the polymer.
However, Leung discloses reflowing the polymer to define a material boundary adjoining the outer jacket and the at least one electrode ([0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Tran to include the steps of Leung, for the purpose of the reflow process enabling the polymer to flow around and encapsulate other features (Leung; [0048]).
Regarding claim 16, Tran in view of Leung disclose causing the polymer to wet a surface of the at least one electrode at the material boundary (Leung: [0046]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202; wherein flowing around and encapsulating is seen as wetting a surface).
Regarding claim 17, Tran discloses seating the at least one electrode in a reduced-diameter segment of the elongate structure (reduced diameter segments 202; [0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202).
Regarding claim 20, Tran discloses:
extending an electrical lead ([0034]: electrical leads (not shown)) through a slot (openings 206) defining a passage from an inner lumen defined by the outer jacket to the at least one electrode ([0034]: A neuromodulation catheter including the distal jacket 200 can include electrical leads (not shown) extending from respective reduced-diameter segments 202, through respective openings 206, through a lumen of the distal hypotube segment 142 (FIGS. 2 and 6), through the intermediate tube 140, and through the proximal hypotube segment 128 to the handle 110. In this way, the electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200);
electrically coupling the electrical lead to the at least one electrode, and extending the electrical lead through the inner lumen ([0034]: A neuromodulation catheter including the distal jacket 200 can include electrical leads (not shown) extending from respective reduced-diameter segments 202, through respective openings 206, through a lumen of the distal hypotube segment 142 (FIGS. 2 and 6), through the intermediate tube 140, and through the proximal hypotube segment 128 to the handle 110. In this way, the electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200).
Regarding claim 21, Tran discloses a catheter (Abstract: A neuromodulation catheter) comprising:
an elongate structure (elongate shaft 108) defining a longitudinal axis (see axis in Fig. 1), wherein the elongate structure includes an outer jacket (distal jacket 200) comprising a polymer ([0035]: Suitable materials for the distal jacket 200 include polymer blends including polyurethane and polysiloxane, among others; [0033]: The distal jacket 200, for example, can be used in the neuromodulation element 112 (FIGS. 1, 2 and 6) in place of the distal jacket 144 (FIGS. 2 and 6)), wherein the outer jacket defines an exterior surface of the elongate structure (see Figs. 1 & 10), wherein the elongate structure defines a plurality of reduced-diameter segments spaced longitudinally apart along the longitudinal axis (reduced diameter segments 202; [0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202), and wherein the outer jacket defines an inner lumen ([0034]: the distal jacket 200 can be tubular; inner lumen of tube);
a plurality of electrodes (electrodes 204a-204d) each configured to emit energy from a respective active area ([0025]: console 104 can be configured to generate radio frequency (RF) energy (e.g., monopolar and/or bipolar RF energy) and/or another suitable type of energy for delivery to tissue at a treatment location via electrodes (not shown) of the neuromodulation element 112),
wherein each electrode of the plurality of electrodes is seated in a respective reduced- diameter segment of the plurality of reduced-diameter segments ([0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202), and
wherein the elongate structure mechanically supports the plurality of electrodes such that the exterior surface and the active areas face outward from the longitudinal axis ([0033]: The distal jacket 200, for example, can be used in the neuromodulation element 112 (FIGS. 1, 2 and 6) in place of the distal jacket 144 (FIGS. 2 and 6). Accordingly, the distal jacket 200 may be described below in conjunction with components of the catheter 102 (FIGS. 1 and 2) … FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202), and wherein the catheter defines a plurality of material boundaries (reduced-diameter segment 202; wherein the reduced diameter segments delineate the material boundaries), the plurality of material boundaries adjoining the outer jacket and the plurality of electrodes ([0034]: The reduced-diameter segments 202 can be insets, pockets, grooves, or other suitable features configured to respectively seat the band electrodes 204), wherein the plurality of material boundaries enable a mechanical adhesion between the polymer and the plurality of electrodes ([0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; [0034]; The reduced-diameter segments 202 can be insets, pockets, grooves, or other suitable features configured to respectively seat the band electrodes 204); and
a plurality of electrical leads, each electrical lead of the plurality electrically coupled to a respective electrode of the plurality of electrodes, wherein the plurality of electrical leads extend through the inner lumen ([0034]: electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200 … distal jacket 200 can include openings 206 respectively positioned at the reduced-diameter segments 202 … electrical leads can respectfully connect the band electrodes 204 to proximal components of a neuromodulation catheter including the distal jacket 200).
But Tran fails to disclose the material boundary formed by reflowing the polymer.
However, Leung discloses the material boundary formed by reflowing the polymer ([0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the material boundary formation process of Tran to be reflow, as taught by Leung, for the purpose of the reflow process enabling the polymer to flow around and encapsulate other features (Leung; [0048]).
Additionally, the recitation of “a material boundary formed by reflowing the polymer” is regarded as a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 23, Tran discloses wherein the elongate structure is convertible between a low-profile delivery configuration and a radially expanded deployed configuration, wherein the elongate structure is configured to have a substantially linear shape when the elongate structure is in the low-profile delivery configuration and configured to have a substantially helical shape when the elongate structure is in the radially expanded deployed configuration ([0031]: In FIGS. 2 and 6, the neuromodulation element 112 is shown in a radially expanded deployed state. The neuromodulation element 112 can be movable from a low-profile delivery state to the radially expanded deployed state. When the neuromodulation element 112 is in the radially expanded deployed state, the distal hypotube segment 142 can have a shape that is more helical (spiral) than its shape when the neuromodulation element 112 is in the low-profile delivery state; [0033]: FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; wherein Fig. 11 is seen as the low-profile delivery state & Fig. 6 I seen as the radially expanded state), and wherein the elongate structure mechanically supports the plurality of electrodes such that the active areas face outward from a central axis defined by the elongate structure when the elongate structure is in the radially expanded deployed configuration ([0033]: The distal jacket 200, for example, can be used in the neuromodulation element 112 (FIGS. 1, 2 and 6) in place of the distal jacket 144 (FIGS. 2 and 6). Accordingly, the distal jacket 200 may be described below in conjunction with components of the catheter 102 (FIGS. 1 and 2) … FIG. 11 is a profile view of the distal jacket 200 and band electrodes 204 (individually identified as band electrodes 204a-204d) respectively seated in the reduced-diameter segments 202; [0031]: In FIGS. 2 and 6, the neuromodulation element 112 is shown in a radially expanded deployed state. The neuromodulation element 112 can be movable from a low-profile delivery state to the radially expanded deployed state).
Claims 2-3 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tran in view of Leung as applied to claims 1 & 14 above, and further in view of Raines (U.S. Pub. No. 20200061371), herein referred to as “Raines”.
Regarding claim 2, Tran in view of Leung fail to disclose wherein the at least one electrode defines a plurality of asperities along the material boundary, and wherein the polymer intrudes into one or more volumes defined by the plurality of asperities to enable the mechanical adhesion.
However, Raines discloses wherein the at least one electrode defines a plurality of asperities along the material boundary, and wherein the polymer intrudes into one or more volumes defined by the plurality of asperities to enable the mechanical adhesion ([0066]: an outer surface of the linked electrode set 300 may be bead blasted to increase the roughness of the surface of the body to improve bonding or adhesion to the insulation material. Also, the inner diameter (not shown) of linked electrode set 300 may be similar processed … The increase in surface roughness may further secure the integration of the metal components with the insulation material provided during the molding process; [0072]: Returning to FIG. 2B, once the electrode subassemblies are loaded with one another along with polymer spacers there between, flow advances to 226. At 226, the process loads a non-metallic mandrel through the spacers and through the mandrel lumen in the electrode subassemblies). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the at least one electrode of Tran in view of Leung to define a plurality of asperities, as taught by Raines, for the purpose of the increase in surface roughness may further secure the integration of the metal components with the insulation material (Raines: [0066]). Wherein in this combination, the modification is only to the surface roughness, the electrodes and reflowing process are still those taught by Tran and Leung.
Regarding claim 3, Tran in view of Leung discloses wherein:
the polymer defines a flow temperature (Leung: [0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202);
the polymer is configured to flow into the one or more volumes when the polymer is heated to the flow temperature ([0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202); and
the polymer is configured to remain in the one or more volumes when the polymer is cooled to a temperature less than the flow temperature ([0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202; wherein this step is seen as being a temporary heating to 660 degrees such that the polymer is allowed to cool after flowing).
Regarding claim 15, Tran in view of Leung discloses wherein reflowing the polymer comprises heating the polymer to a flow temperature to cause the polymer to reflow into one or more volumes (Leung: [0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202), the method further comprising cooling the reflowed polymer to a temperature less than the flow temperature ([0048]: A process combining re-flow and heat-shrink is used and the dual polymer layer is heated to a temperature of about 660° F., allowing the inner FEP layer to flow around and encapsulate the one or more radiopaque bands 130 disposed on core wire 202; wherein this step is seen as being a temporary heating to 660 degrees such that the polymer is allowed to cool after flowing).
But Tran in view of Leung fail to disclose one or more volumes defined by a plurality of asperities defined by the at least one electrode to enable the mechanical adhesion.
However, Raines discloses one or more volumes defined by a plurality of asperities defined by the at least one electrode to enable the mechanical adhesion ([0066]: an outer surface of the linked electrode set 300 may be bead blasted to increase the roughness of the surface of the body to improve bonding or adhesion to the insulation material. Also, the inner diameter (not shown) of linked electrode set 300 may be similar processed … The increase in surface roughness may further secure the integration of the metal components with the insulation material provided during the molding process; [0072]: Returning to FIG. 2B, once the electrode subassemblies are loaded with one another along with polymer spacers there between, flow advances to 226. At 226, the process loads a non-metallic mandrel through the spacers and through the mandrel lumen in the electrode subassemblies). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the at least one electrode of Tran in view of Leung to one or more volumes defined by a plurality of asperities, as taught by Raines, for the purpose of the increase in surface roughness may further secure the integration of the metal components with the insulation material (Raines: [0066]). Wherein in this combination, the modification is only to the surface roughness, the electrodes and reflowing process are still those taught by Tran and Leung.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Tran in view of Leung as applied to claim 1 above, and further in view of Guo et al. (U.S. Pub. No. 20200406025), herein referred to as “Guo”.
Regarding claim 4, Tran in view of Leung fail to disclose wherein the polymer is mechanically interlocked with a surface of the at least one electrode at the material boundary.
However, Guo discloses wherein the polymer is mechanically interlocked with a surface of the at least one electrode at the material boundary ([0060]: After a conductor 314 has been assembled to each of electrodes 310 and 312, the electrodes are inserted into cavities 154 and 156, respectively, and the distal end of the sheath may again be subjected to a reflow heating process to partially or completely melt the outer polymer of braided layer 112 and outer polymer layer 114 to mechanically interlock the electrodes with the sheath's polymer material. FIG. 9C is a cross-sectional view showing electrode 310 embedded within the polymer at the distal end of sheath 102). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the surface of the at least one electrode of Tran in view of Leung, to be mechanically interlocked with the polymer, as taught by Guo, for the purpose of mechanically interlocking the electrodes with the polymer material (Guo: [0060]).
Claims 8 & 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tran in view of Leung as applied to claims 1 & 14 above, and further in view of Just et al. (U.S. Pub. No. 20120143298), herein referred to as “Just”.
Regarding claim 8, Tran in view of Leung fail to disclose wherein the outer jacket defines a jacket lumen and a window defining a passage from the jacket lumen to the exterior surface of the outer jacket,
wherein the at least one electrode is positioned at least partially within the jacket lumen, and
wherein the elongate structure mechanically supports the at least one electrode such that the window substantially surrounds the active area of the at least one electrode.
However, Just discloses wherein the outer jacket (outer covering 90) defines a jacket lumen (lumen of the tubing of outer covering 90; [0036]: The outer covering 90 may comprise a polymer. In an embodiment, the outer covering 90 comprises a thin-walled heat shrinkable tubing) and a window defining a passage from the jacket lumen to the exterior surface of the outer jacket ([0038]: Following the application of the outer covering 90, a portion of the outer covering 90 adjacent each electrode 62, 64 or 82, 84, 86 can be removed to expose the conductive electrode surface 92 … the exposed conductive electrode surface 92 can be created by preventing the outer covering 90 from bonding to at least a portion of electrode 62, 64 or 82, 84, 86; wherein this is seen in Figs. 2-3 where the electrode 62 is positioned within a window defining a passage from the jacket lumen (where electrode 62 is shown in Fig. 3 as being within) and the electrode extends to an exterior surface of the outer covering 90),
wherein the at least one electrode is positioned at least partially within the jacket lumen (see Figs. 2-3 where the electrode 62 is shown within the tubing of the outer covering 90), and
wherein the elongate structure mechanically supports the at least one electrode such that the window substantially surrounds the active area of the at least one electrode (see Fig. 2 where the outer covering 90 supports electrode 62 and forms a window that substantially surrounds the active area of electrode 62; see also the manufacturing process in Fig. 9). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the outer jacket of Tran in view of Leung to the outer jacket of Just for the purpose of mechanically fastening (encapsulating the elements in a common tubing) to prevent relative movement during assembly and use, and allowing for the exposed conductive electrode surface to be in a preferred location and/or face in a preferred direction (Just: [0033], [0038]).
Regarding claim 18, Tran in view of Leung fail to disclose defining the reduced-diameter segment by adjoining an internal jacket member of the outer jacket and an external jacket member of the outer jacket.
However, Just discloses defining the reduced-diameter segment by adjoining an internal jacket member (liner tube 88) of the outer jacket and an external jacket member (outer covering 90) of the outer jacket ([0045]: The process of bonding can be achieved by heat-shrinking or reflowing the outer covering 90 to the electrode 62, flexible circuit 68, and/or liner tube 88 … the assembly thus formed (i.e., the flexible circuit 68, electrode 62, and liner tube 88) can be subjected to a reflow lamination process, which involves heating the assembly until the outer covering 90 flows and redistributes around the circumference).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Tran in view of Leung to include the steps of Just for the purpose of mechanically fastening (encapsulating the elements in a common tubing) to prevent relative movement during assembly and use, and allowing for the exposed conductive electrode surface to be in a preferred location and/or face in a preferred direction (Just: [0033], [0038]).
Regarding claim 19, Tran in view of Leung fail to disclose mechanically supporting the at least one electrode such that a window defining a passage from an inner lumen of the outer jacket to the exterior surface of the outer jacket substantially surrounds the active area of the at least one electrode.
However, Just discloses mechanically supporting the at least one electrode (electrodes 62, 64, 82 or 84) such that a window defining a passage from an inner lumen (lumen of the tubing of outer covering 90) of the outer jacket (outer covering 90) to the exterior surface of the outer jacket substantially surrounds the active area of the at least one electrode ([0038]: Following the application of the outer covering 90, a portion of the outer covering 90 adjacent each electrode 62, 64 or 82, 84, 86 can be removed to expose the conductive electrode surface 92 … the exposed conductive electrode surface 92 can be created by preventing the outer covering 90 from bonding to at least a portion of electrode 62, 64 or 82, 84, 86; wherein this is seen in Figs. 2-3 where the electrode 62 is positioned within a window defining a passage from the jacket lumen (where electrode 62 is shown in Fig. 3 as being within) and the electrode extends to an exterior surface of the outer covering 90, see also the manufacturing process in Fig. 9).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the method of Tran in view of Leung to include the steps of Just for the purpose of mechanically fastening (encapsulating the elements in a common tubing) to prevent relative movement during assembly and use, and allowing for the exposed conductive electrode surface to be in a preferred location and/or face in a preferred direction (Just: [0033], [0038]).
Claims 11 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tran in view of Leung as applied to claims 1 & 21 above, and further in view of Kelly et al. (U.S. Pub. No. 20150305807), herein referred to as “Kelly”.
Regarding claim 11, Tran in view of Leung fail to disclose wherein the electrical lead comprises a wire pair electrically coupled to the at least one electrode at a coupling point, and wherein the coupling point comprises a thermocouple.
However, Kelly discloses wherein the electrical lead comprises a wire pair electrically coupled to the at least one electrode at a coupling point, and wherein the coupling point comprises a thermocouple ([0005]: one or more thermocouples (“TC”); [0053]: A distal portion of each of the TC assemblies 204 can be electrically coupled to a corresponding electrode 106; [0064]: Each TC assembly 204a-d can include a first wire 210 (labeled individually 210a-d) and a second wire 212 (labeled individually 212a-d) made of dissimilar metals). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrical leads of Tran in view of Leung to comprise a coupling point, as taught by Kelly, for the purpose of measuring temperature at or near an electrode (Kelly: [0005], [0063]).
Regarding claim 22, Tran in view of Leung fail to disclose wherein at least one electrical lead of the plurality of electrical leads comprises a wire pair electrically coupled to a respective electrode at a coupling point, and wherein the coupling point comprises a thermocouple.
However, Kelley discloses wherein at least one electrical lead of the plurality of electrical leads comprises a wire pair electrically coupled to a respective electrode at a coupling point, and wherein the coupling point comprises a thermocouple ([0005]: one or more thermocouples (“TC”); [0053]: A distal portion of each of the TC assemblies 204 can be electrically coupled to a corresponding electrode 106; [0064]: Each TC assembly 204a-d can include a first wire 210 (labeled individually 210a-d) and a second wire 212 (labeled individually 212a-d) made of dissimilar metals). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrical leads of Tran in view of Leung to comprise a coupling point, as taught by Kelly, for the purpose of measuring temperature at or near an electrode (Kelly: [0005], [0063]).
Conclusion
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/ABIGAIL M ZIEGLER/ /BEVERLY M FLANAGAN/Examiner, Art Unit 3794 Primary Examiner, Art Unit 3794
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