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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to German Application No. 10 2020 118 373.9 filed on July 13, 2020. The certified copy has been filed in parent Application No. 17/374,366. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The Amendments under 37 CFR 1.132 filed 07/15/2025 is insufficient to overcome the rejection of claim 1 based upon as being unpatentable over Spelman (US 5800500 A) in view of Cattaneo (US 20130237789 A1), further in view of Kassab (US 20180019039 A1) as set forth in the last Office action because:
Cattaneo teaches wherein the second material is mechanical and electrically-conductively connected to the conductor element after the second material is melted (Fig 1; [0070] The inner layer 12 can be made available as a wire, for example, in the production of the electrode tip. During the production process, the wire can serve as a substrate for the outer layer 11 or jacket layer. The jacket layer or outer layer 11 can be deposited on the inner layer 12 by a sputtering process. The outer layer 11 and the inner layer 12 can merge smoothly or continuously into each other. This means that there are no clearly defined interfaces between the outer and inner layers 11, 12).
Response to Arguments
Applicant's arguments filed 07/15/2025 have been fully considered but they are not persuasive. Spelman teaches an exterior wall (Fig 12; element sheath 220); and a contact element directly connected to the exterior wall (Fig 12; [32] electrical lead 222 and heating element sheath 220 are in contact), the contact element being arranged eccentrically within the exterior wall (Fig 9b and 12; conductor 118 located within core 116) wherein the exterior wall comprises a first material ([33] heating element sheath 220 may be made out of any of the great multiplicity of materials that are conductive enough to bear current and are resistive enough to be warmed up by it. Many metals and alloys are available for this purpose. Conductive polymers that may be applied in liquid form and set are of particular interest with respect to heating element sheath 220).
Cattaneo teaches the contact element comprises a second material ([0072] outer layer composed of nitinol); wherein the second material has a lower melting point than the first material ([0072] outer layer composed of nitinol) and wherein the second material is mechanical and electrically-conductively connected to the conductor element after the second material is melted (Fig 1; [0070] The inner layer 12 can be made available as a wire, for example, in the production of the electrode tip. During the production process, the wire can serve as a substrate for the outer layer 11 or jacket layer. The jacket layer or outer layer 11 can be deposited on the inner layer 12 by a sputtering process. The outer layer 11 and the inner layer 12 can merge smoothly or continuously into each other. This means that there are no clearly defined interfaces between the outer and inner layers 11, 12).
Therefore, the combination of Spelman in view of Cattaneo teaches wherein the second material (Cattaneo; [0072] outer layer composed of nitinol) has a lower melting point than the first material (Spelman; [33] heating element sheath 220 may be made out of any of the great multiplicity of materials that are conductive enough to bear current and are resistive enough to be warmed up by it. Many metals and alloys are available for this purpose. Conductive polymers that may be applied in liquid form and set are of particular interest with respect to heating element sheath 220); and wherein the second material is mechanical and electrically-conductively connected to the conductor element after the second material is melted. It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a first material with a higher melting point made of a metal/alloy that could withstand the heating to bear current and to be resistive enough to be warmed up by the second material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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.
Claim(s) 1, 2, 4, 7-9, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spelman (US 5800500 A) in view of Cattaneo (US 20130237789 A1), further in view of Kassab (US 20180019039 A1).
Regrading claim 1, Spelman teaches a ring electrode for electrical stimulation or sensing on the human body comprising: an exterior wall (Fig 12; element sheath 220); and a contact element directly connected to the exterior wall (Fig 12; [32] electrical lead 222 and heating element sheath 220 are in contact), the contact element being arranged eccentrically within the exterior wall (Fig 9b and 12; conductor 118 located within core 116) wherein the exterior wall comprises a first material ([33] heating element sheath 220 may be made out of any of the great multiplicity of materials that are conductive enough to bear current and are resistive enough to be warmed up by it. Many metals and alloys are available for this purpose. Conductive polymers that may be applied in liquid form and set are of particular interest with respect to heating element sheath 220) the contact element comprises a second material ([22] electrical conductor or conductors 118) ([29] Conductors 130 and 132 may comprise gold, platinum, or silver wires or alloys of these metals and other metals, such as iridium; conductive epoxies or conductive paints); wherein the exterior wall and an outer side of the contact element define comprises a through-opening (Fig 9b; exterior insulative coating 121 and insulative coating 120 define electrical conductor 118 and core 116); and wherein an inner side of the contact element and an inner side of the exterior wall define the contact element comprises a contacting opening between them that is configured for connection to a conductor element (Fig 9b; electrical conductor 118) ([22] Electrical conductor 118 is insulated from shape memory material core 116 by insulative coating 120, except at connection point 114 where conductor 118 and core 116 are in electrical contact); and wherein the exterior wall and the contact element through-opening and the contacting opening each independently form a separate tubular structure (Fig 12; 222 and 216).
Spelman fails to teach wherein the second material has a lower melting point than the first material; a contacting opening between them that is configured to receive a cable; and wherein the second material is mechanical and electrically-conductively connected to the conductor element after the second material is melted.
However, Cattaneo teaches the contact element comprises a second material ([0072] outer layer composed of nitinol); wherein the second material has a lower melting point than the first material ([0072] outer layer composed of nitinol) and wherein the second material is mechanical and electrically-conductively connected to the conductor element after the second material is melted (Fig 1; [0070] The inner layer 12 can be made available as a wire, for example, in the production of the electrode tip. During the production process, the wire can serve as a substrate for the outer layer 11 or jacket layer. The jacket layer or outer layer 11 can be deposited on the inner layer 12 by a sputtering process. The outer layer 11 and the inner layer 12 can merge smoothly or continuously into each other. This means that there are no clearly defined interfaces between the outer and inner layers 11, 12).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to wherein the second material has a lower melting point than the first material; a contacting opening between them that is configured to receive a cable; and wherein the second material is mechanical and electrically-conductively connected to the conductor element after the second material is melted. Doing so allows the first material to withstand more heating than the second for electrical conduction to the outer layer. Further, It would have been obvious to one having ordinary skill in the art at the time the invention was made to select a first material with a higher melting point made of a metal/alloy that could withstand the heating to bear current and to be resistive enough to be warmed up by the second material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Further, Kassab teaches a through-opening between them that is configured to receive a cable ([0183] FIG. 3A shows an exemplary core wire used as a body 102 of the present application prior to having any grooves therein. As shown in FIG. 3A, body 102 is an elongated core wire which may be comprised of stainless steel, a nickel titanium alloy (such as Nitinol), copper, a nickel alloy (such as Monel), a combination of the foregoing, and/or another material suitable as a conductor wire 110 that is sufficiently rigid, when one or more grooves 104 are present therein, to be safely inserted into a patient). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include a through-opening between them that is configured to receive a cable. Doing so provides a cable within the core to provide stability and conductivity.
Regarding claim 2, Spelman teaches the ring electrode according to claim 1, wherein the second material is selected from the group consisting of Pt, Cu, Pd, Ti, Fe, Au, Mo, Ni, MP35N, 316L, 301, 304, and an active solder ([22] electrical conductor or conductors 118) ([29] Conductors 130 and 132 may comprise gold, platinum, or silver wires or alloys of these metals and other metals, such as iridium; conductive epoxies or conductive paints).
Regarding claim 4, Spelman teaches the ring electrode according to claim 1, but fails to fully teach further comprising a diffusion barrier between the first material and the second material. However, Cattaneo teaches further comprising a diffusion barrier between the first material and the second material (Fig 6a; [0087] intermediate layer 13, which extends between the outer layer 11 and the inner layer 12). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include a diffusion barrier between the first material and the second material. Doing so would partially insulate between the two materials.
Regarding claim 7, Spelman teaches an electrode system comprising a ring electrode according to claim 1 and a conductor element (Fig 9b; conductor 118), wherein the conductor element is arranged within the contacting opening and is integrally bonded to the contact element and is alloyed therewith (Fig 9b; [22] where conductor 118 and core 116 are in electrical contact).
Regarding claim 8, Spelman teaches a method for connecting a ring electrode according to claim 1 to a conductor element (Fig 9b; 118), comprising the conductor element being arranged at least partially within the contacting opening (Fig 9b; conductor 118 arranged within core 116); (ii) heating the contact element and thereby forming an integral bond between the second material and the conductor element (Fig 9b; [22] where conductor 118 and core 116 are in electrical contact), but fails to fully teach comprising: (i) bringing the ring electrode into contact with the conductor element, heating the contact element and thereby forming an integral bond between the second material and the conductor element, wherein the formation of an integral bond preferably comprises the formation of an alloy.
However, Cattaneo teaches (i) bringing the ring electrode into contact with the conductor element (Fig 1; [0070] During the production process, the wire can serve as a substrate for the outer layer 11 or jacket layer. The jacket layer or outer layer 11 can be deposited on the inner layer 12 by a sputtering process. The outer layer 11 and the inner layer 12 can merge smoothly or continuously into each other. This means that there are no clearly defined interfaces between the outer and inner layers 11, 12), heating the contact element and thereby forming an integral bond between the second material and the conductor element ([0036] A radially continuous transition can be present between the layers. The electrode tip can thus substantially correspond to the configuration of a graded-index fiber, with a material gradient being provided between the radial outer circumference of the electrode tip and the longitudinal axis of the electrode tip. The material of the outer layers and the material of the inner layers can run into each other or merge smoothly into each other), wherein the formation of an integral bond preferably comprises the formation of an alloy ([0037] he radially inner layer or the radially inner layers can be composed of a nickel-titanium alloy and the radially outer layer or the radially outer layers can be composed of a material with higher electrical conductivity than the material of the radially inner layer or the radially inner layer). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include bringing the ring electrode into contact with the conductor element, heating the contact element and thereby forming an integral bond between the second material and the conductor element, wherein the formation of an integral bond preferably comprises the formation of an alloy. Doing so creates an integral bond for conductive transfer between the conductor element and the ring electrode.
Regarding claim 9, Spelman teaches the method according to claim 8, wherein heating of the contact element is affected by heating the outer side of the exterior wall (Fig 9b; [22] where conductor 118 and core 116 are in electrical contact).
Regarding claim 11, Spelman teaches the method according to claim 8, further comprising compressing the conductor element within the contacting opening to produce a frictional connection between the conductor element and the contact element (Fig 9b; [22] where conductor 118 within coating 120).
Regarding claim 12, Spelman teaches an electrode system produced by the method according to claim 8 (Fig 7; active electrodes 20).
Claim(s) 3, 5, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spelman (US 5800500 A) in view of Cattaneo (US 20130237789 A1), further in view of Kassab (US 20180019039 A1), further in view of Chen (US 20090118705 A1).
Regarding claim 3, Spelman teaches the ring electrode according to claim 1, but fails to teach wherein the first material is selected from the group consisting of Pt, Ir, Ta, Pd, Ti, Fe, Au, Mo, Nb, W, Ni, Ti, MP35N, 316L, 301 and 304. However, Chen teaches wherein the first material is selected from the group consisting of Pt, Ir, Ta, Pd, Ti, Fe, Au, Mo, Nb, W, Ni, Ti, MP35N, 316L, 301 and 304 ([0045] The outer zone of material 240 may be any of various materials, such as any of those discussed above, or others. For instance, the outer zone of material 240 may be a biocompatible material such as titanium or a titanium alloy, tungsten or a tungsten alloy, tantalum or a tantalum alloy, chromium or a chromium alloy, niobium or a niobium alloy, zirconium or a zirconium alloy, platinum or a platinum alloy, combinations thereof, and the like, or any other suitable material). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include wherein the first material is selected from the group consisting of Pt, Ir, Ta, Pd, Ti, Fe, Au, Mo, Nb, W, Ni, Ti, MP35N, 316L, 301 and 304. Doing so allows the first material to be comprised of a metal that has a higher melting point than the second material.
Regarding claim 5, Spelman teaches the ring electrode according to claim 1, but fails to teach wherein the absolute melting point [K] of the first material is at least 1.1 times the absolute melting point of the second material. However, Chen teaches a first material being of titanium or a titanium alloy, tungsten or a tungsten alloy, tantalum or a tantalum alloy, chromium or a chromium alloy, niobium or a niobium alloy, zirconium or a zirconium alloy, platinum or a platinum alloy, combinations thereof, and the like, or any other suitable material [0045] (If first material is platinum alloy and second material is gold, the absolute melting point of the first material is at least 1.1 times the absolute melting point of the second material). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include wherein the first material is selected from the group consisting of Pt, Ir, Ta, Pd, Ti, Fe, Au, Mo, Nb, W, Ni, Ti, MP35N, 316L, 301 and 304 and wherein the second material is selected from the group consisting of Pt, Cu, Pd, Ti, Fe, Au, Mo, Ni, MP35N, 316L, 301, 304. Doing so allows the first material to be comprised of a metal that has a higher melting point than the second material.
Regarding claim 6, Spelman teaches the ring electrode according to claim 1, but fails to teach wherein the absolute melting point [K] of the first material is at least 2 times the absolute melting point of the second material. However, Chen teaches a first material being a first material being of titanium or a titanium alloy, tungsten or a tungsten alloy, tantalum or a tantalum alloy, chromium or a chromium alloy, niobium or a niobium alloy, zirconium or a zirconium alloy, platinum or a platinum alloy, combinations thereof, and the like, or any other suitable material ([0045]) (If first material is platinum alloy and second material is gold, the absolute melting point of the first material is at least 2 times the absolute melting point of the second material). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include wherein the first material is selected from the group consisting of Pt, Ir, Ta, Pd, Ti, Fe, Au, Mo, Nb, W, Ni, Ti, MP35N, 316L, 301 and 304 and wherein the second material is selected from the group consisting of Pt, Cu, Pd, Ti, Fe, Au, Mo, Ni, MP35N, 316L, 301, 304. Doing so allows the first material to be comprised of a metal that has a higher melting point than the second material.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spelman (US 5800500 A) in view of Cattaneo (US 20130237789 A1), further in view of Kassab (US 20180019039 A1), further in view of Larsen Larsen (US 20130296678 A1).
Regarding claim 10, Spelman teaches the method according to claim 8, but fails to teach wherein heating of the contact element is affected by induction heating or local heat input by a laser beam or resistance welding. However, Larsen teaches wherein heating of the contact element is affected by induction heating or local heat input by a laser beam or resistance welding ([0016] one or both of the forming steps are performed using a laser ablation process). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Spelman to include wherein heating of the contact element is affected by induction heating or local heat input by a laser beam or resistance welding. Doing so allows for an effective heating of the contact element without causing outer damage.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794