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
2. Applicant’s election without traverse of the following species:from Group A: Embodiment 2 (claim 7)
from Group B: Embodiment 4 (claim 9)
in the reply filed on 8/26/2025 is acknowledged. Thus, claims 1-5, 7, and 9-20 are pending. Claims 6 and 8 are withdrawn from consideration.
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 and 10-20 are rejected under 35 U.S.C 103 as being unpatentable over Kirson et al. (US Pub.: 2020/0171297 A1 – Applicant Cited) and further in view of Eckhouse et al. (US Pub.: 2013/0226269 A1).
Regarding claim 1, Kirson teaches a system for delivering tumor-treating fields to a body of a patient (e.g. abstract; paragraph 0002), the system comprising:
an electrode subassembly (Fig. 1 – transducer array 100) comprising:
a circuitry layer (102) having a skin-facing inner side and an outer side (102 has a skin-facing inner side and an outer side);
a plurality of electrodes (110) disposed on the inner side of the circuitry layer and electrically coupled to the circuitry layer (e.g. paragraph 0042), wherein each electrode of the plurality of electrodes has an electrode edge (104);
a covering layer (126) having an inner side and an outer side (126 has an inner and outer side), wherein the inner side is disposed on the outer side of the circuitry layer (e.g. paragraph 0051), wherein portions of the covering layer extend beyond the circuitry layer and beyond the electrode edge of each of the electrodes to define at least one attachment surface (e.g. paragraph 0053);
and at least one replaceable adhesive subassembly (100; paragraphs 0004-0005) comprising:
a support layer (122) having a first side and a second side (122 has a first and second side), wherein the support layer defines at least one opening that is configured to receive therein a respective electrode of the plurality of electrodes (e.g. paragraph 0046);
a first adhesive that is disposed on the first side of the support layer (e.g. paragraph 0047, – synthetic rubber adhesive), wherein the first adhesive is configured to couple the support layer to the inner side of the covering layer of the electrode subassembly at the at least one attachment surface of the covering layer (e.g. paragraph 0047);
and a biocompatible adhesive that is disposed on the second side of the support layer (e.g. paragraph 0049, – acrylate adhesive).
However, Kirson does not explicitly teach that the biocompatible adhesive disposed on the second side of the support layer is a biocompatible conductive adhesive.
Eckhouse, in a same field of endeavor of electrode stimulation devices, discloses a biocompatible conductive adhesive used in a patch electrode (e.g. paragraph 0025).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Kirson to include a biocompatible conductive adhesive, as taught and suggested by Eckhouse, in order to enable firm electrical and mechanical coupling of the electrode to the skin when the patch is applied to the skin (Eckhouse, paragraph 0025).
Regarding claim 2, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above, wherein the at least one replaceable adhesive subassembly comprises a second adhesive that is disposed on the second side of the support layer (adhesive 118 of Kirson [0048]) and adheres the biocompatible conductive adhesive to the support layer (Eckhouse [0025]).
Regarding claim 3, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above, and Kirson further teaches wherein the support layer of the at least one replaceable adhesive subassembly comprises foam (e.g. paragraph 0046, – foam layer 122).
Regarding claim 4, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above, and Kirson further teaches wherein the first adhesive is a nonpermanent adhesive that is configured to permit release from the at least one attachment surface of the covering layer (e.g. paragraph 0047).
Regarding claim 5, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above, wherein the biocompatible conductive adhesive (Eckhouse [0025]) of the at least one replaceable adhesive subassembly has a first side facing the support layer and an opposing second side (Kirson Fig. 1), wherein the at least one replaceable adhesive subassembly comprises a first release liner disposed on the opposing second side (Kirson 140) of the biocompatible conductive adhesive (Eckhouse [0025]).
Regarding claim 10, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above, and Kirson further teaches wherein the first adhesive has a first side that faces the support layer and an opposing second side (122), wherein the at least one replaceable adhesive subassembly further comprises a second release liner (140) positioned against the opposing second side of the first adhesive (e.g. paragraph 0056).
Regarding claim 11, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above, wherein the at least one replaceable adhesive subassembly comprises a plurality of replaceable adhesive subassemblies, wherein one or more of the plurality of replaceable adhesive subassemblies comprises a plurality of replacement adhesive subassemblies, wherein a replacement adhesive subassembly comprises:
a support layer having a first side and a second side (foam layer 122 of Kirson), wherein the support layer defines at least one opening that is configured to receive therein a respective electrode of the electrode subassembly (Kirson [0046]);
a first adhesive that is disposed on the first side of the support layer (Kirson [0047], – synthetic rubber adhesive) and is configured to couple the support layer to the covering layer of the electrode subassembly at the at least one attachment surface of the covering layer (Kirson [0047]) and a biocompatible conductive adhesive (Eckhouse [0025]) that is disposed on the second side of the support layer (Kirson [0049]).
Regarding claim 12, Kirson teaches a replaceable adhesive subassembly (e.g. Fig. 1 – transducer array 100; paragraphs 0004-0005) for use with an electrode subassembly having a plurality of electrodes (110) and a covering layer that defines at least one attachment surface (e.g. Fig. 1 – covering layer 126 paragraph 0047), the replaceable adhesive subassembly comprising:
a support layer (122) having a first side and a second side (122 has a first and second side), wherein the support layer defines at least one opening that is configured to receive therein a respective electrode of the plurality of electrodes of the electrode subassembly (e.g. paragraph 0046);
a first adhesive that is disposed on the first side of the support layer (e.g. paragraph 0047, – synthetic rubber adhesive) and is configured to couple the support layer to the covering layer of the electrode subassembly at the at least one attachment surface of the covering layer (e.g. paragraph 0047);
and a biocompatible adhesive that is disposed on the second side of the support layer (e.g. paragraph 0049, – acrylate adhesive).
However, Kirson does not explicitly teach that the biocompatible adhesive disposed on the second side of the support layer is a biocompatible conductive adhesive.
Eckhouse, in a same field of endeavor of electrode stimulation devices, discloses a biocompatible conductive adhesive used in a patch electrode (e.g. paragraph 0025).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the subassembly of Kirson to include a biocompatible conductive adhesive, as taught and suggested by Eckhouse, in order to enable firm electrical and mechanical coupling of the electrode to the skin when the patch is applied to the skin (Eckhouse, paragraph 0025).
Regarding claim 13, Kirson in view of Eckhouse teaches the replaceable adhesive subassembly of claim 12 as discussed above, comprising a second adhesive that is disposed on the second side of the support layer (adhesive 118 of Kirson [0048]) and adheres the biocompatible conductive adhesive to the support layer (Eckhouse [0025]).
Regarding claim 14, Kirson in view of Eckhouse teaches the replaceable adhesive subassembly of claim 12 as discussed above, wherein the biocompatible conductive adhesive (Eckhouse [0025]) has a first side facing the support layer and an opposing second side (Kirson Fig. 1), wherein the replaceable adhesive subassembly comprises a first release liner disposed on the opposing second side (Kirson 140) of the biocompatible conductive adhesive (Eckhouse [0025]).
Regarding claim 15, Kirson in view of Eckhouse teaches the replaceable adhesive subassembly of claim 12 as discussed above, and Kirson further teaches wherein the first adhesive has a first side that faces the support layer and an opposing second side (e.g. paragraph 0047), wherein the replaceable adhesive subassembly further comprises a second release liner (140) positioned against the opposing second side of the first adhesive (e.g. paragraph 0056).
Regarding claim 16, Kirson teaches a method comprising:
applying, to a patient, an assembly (e.g. abstract, paragraph 0004) comprising:
an electrode subassembly (Fig. 1 – transducer array 100) comprising:
a circuitry layer (102) having an inner side and an outer side (102 has a skin-facing inner side and an outer side);
a plurality of electrodes (110) disposed on the inner side of the circuitry layer and electrically coupled to the circuitry layer (e.g. paragraph 0042), wherein each electrode of the plurality of electrodes has an electrode edge (104);
a covering layer (126) having an inner side and an outer side, wherein the inner side is disposed on the outer side of the circuitry layer (e.g. paragraph 0051), wherein portions of the inner side of the covering layer extend beyond the circuitry layer and beyond the electrode edge of each of the electrodes to define at least one attachment surface (e.g. paragraph 0053);
and at least one replaceable adhesive subassembly (e.g. Fig. 1 – transducer array 100; paragraphs 0004-0005) comprising:
a support layer (122) having a first side and a second side (122 has a first and a second side), wherein the support layer defines at least one opening, wherein each electrode of the plurality of electrodes is received within a respective opening of the at least one opening (e.g. paragraph 0046);
a first adhesive that is disposed on the first side of the support layer (e.g. paragraph 0047, – synthetic rubber adhesive) and couples the support layer to the inner side of the covering layer of the electrode subassembly at the at least one attachment surface of the covering layer (e.g. paragraph 0047);
and a biocompatible adhesive that is disposed on the second side of the support layer (e.g. paragraph 0049, – acrylate adhesive).
However, Kirson does not explicitly teach that the biocompatible adhesive disposed on the second side of the support layer is a biocompatible conductive adhesive.
Eckhouse, in a same field of endeavor of electrode stimulation devices, discloses a biocompatible conductive adhesive used in a patch electrode (e.g. paragraph 0025).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Kirson to include a biocompatible conductive adhesive, as taught and suggested by Eckhouse, in order to enable firm electrical and mechanical coupling of the electrode to the skin when the patch is applied to the skin (Eckhouse, paragraph 0025).
Regarding claim 17, Kirson in view of Eckhouse teaches the method of claim 16 as discussed above, and Kirson further teaches removing one or more of the at least one replaceable adhesive subassembly from the electrode subassembly (e.g. paragraphs 0004, 0042);
and applying one or more replacement adhesive subassemblies to the electrode subassembly (e.g. paragraphs 0004, 0042), wherein each replacement adhesive subassembly of the one or more replacement adhesive subassemblies (e.g. paragraph 0004) comprises:
a support layer (122) having a first side and a second side (122 has a first and a second side), wherein the support layer defines at least one opening that is configured to receive therein a respective electrode of the plurality of electrodes (e.g. paragraph 0046);
a first adhesive that is disposed on the first side of the support layer (e.g. paragraph 0047, – synthetic rubber adhesive), wherein the first adhesive is configured to couple the support layer to the inner side of the covering layer of the electrode subassembly at the at least one attachment surface of the covering layer (e.g. paragraph 0047); and a biocompatible adhesive that is disposed on the second side of the support layer (e.g. paragraph 0049). Additionally, Eckhouse teaches that the biocompatible adhesive is conductive (e.g. paragraph 0025).
Regarding claim 18, Kirson in view of Eckhouse teaches the method of claim 17 as discussed above, and Kirson further teaches prior to removing one or more of the at least one replaceable adhesive subassembly from the electrode subassembly, removing the assembly from the patient (e.g. paragraphs 0004-0005); and
applying, to the patient, the one or more replacement adhesive subassemblies with the electrode subassembly attached thereto (e.g. paragraphs 0004-0005).
Regarding claim 19, Kirson in view of Eckhouse teaches the method of claim 18 as discussed above, wherein the biocompatible conductive adhesive (Eckhouse [0025]) of each replacement adhesive subassembly of the one or more replacement adhesive subassemblies has a first side that faces the support layer and an opposing second side (Kirson Fig. 1), and a first release liner is positioned against the opposing second side (Kirson 140) of the biocompatible conductive adhesive of the replacement adhesive subassembly (Eckhouse [0025]), wherein the first adhesive of each replacement adhesive subassembly has a first side positioned against the support layer and an opposing second side (Kirson 122), and a second release liner (Kirson 140) is disposed on the opposing second side of the first adhesive (Kirson [0056]), and wherein the method further comprises:
removing the second release liner prior to applying the replacement adhesive subassembly to the electrode subassembly (Kirson [0004], [0056]); and removing the first release liner prior to applying, to the patient, the one or more replacement adhesive subassemblies with the electrode subassembly attached thereto (Kirson [0004], [0056]).
Regarding claim 20, Kirson in view of Eckhouse teaches the method of claim 18 as discussed above, and Kirson further teaches delivering, using the electrode subassembly, tumor-treating fields to the patient (e.g. paragraphs 0002, 0004).
Claim 7 is rejected under 35 U.S.C 103 as being unpatentable over Kirson and further in view of Eckhouse and further in view of Bogie et al. (US Pub.: 2023/0158293 A1).
Regarding claim 7, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above. Eckhouse teaches a biocompatible conductive adhesive (e.g. paragraph 0025). However, Kirson in view of Eckhouse does not explicitly teach wherein the biocompatible conductive adhesive comprises a conductive adhesive composite.
Bogie, in a same field of endeavor of electrode stimulation devices, discloses a biocompatible conductive adhesive comprising a conductive adhesive composite (e.g. paragraph 0116, – silver conductive epoxy adhesive is a composite). Although Bogie fails to explicitly state that the silver epoxy adhesive is biocompatible, the layer is interpreted to be biocompatible on the fact that it is used as a skin contacting layer.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kirson and Eckhouse to include a biocompatible conductive adhesive comprising conductive adhesive composite, as taught and suggested by Bogie, because it is a simple substitution of one known adhesive used for electrodes for another in order to obtain the predictable results of maintaining good electrical conductivity as well as maintaining good contact with the skin.
Claim 9 is rejected under 35 U.S.C 103 as being unpatentable over Kirson and further in view of Eckhouse and further in view of Von Novak et al. (US Pub.: 2019/0134409 A1) (hereinafter, ‘Novak’).
Regarding claim 9, Kirson in view of Eckhouse teaches the system of claim 1 as discussed above. However, Kirson in view of Eckhouse does not explicitly teach wherein the plurality of electrodes comprise at least one reusable high-dielectric polymer electrode.
Novak, in a same field of endeavor of electrode stimulation devices, discloses wherein the plurality of electrodes comprise at least one reusable high-dielectric polymer electrode (e.g. paragraph 0030, – electrode with polyethylene).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Kirson and Eckhouse to include at least one reusable high-dielectric polymer electrode (i.e. electrode with polyethylene), as taught and suggested by Novak, in order to prevent contact between the electrode and tissue at a specific portion of the electrode array (Novak, paragraph 0030).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792