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 .
Response to Amendment
2. This action is responsive to the amendments filed 6/2/2026. Claims 1, 5, 12, 14, and 16-19 have been amended. No claims were newly added. Claims 10 and 15 has been canceled.
Response to Arguments
3. Applicant’s arguments filed on 6/2/2026 with respect to the prior art rejections have been fully considered. In substance, applicant argues that A) Kirson does not teach a release liner that is positioned against the opposing second side of the first adhesive and B) Kirson does not teach removing one or more of the at least one replaceable adhesive subassembly from the electrode assembly as recited in claim 16.
4. In response to A), the examiner respectfully disagrees.
At the onset, it is important to note the scope of the claims. The claims do not require a particular manner of contact (i.e. direct/indirect) between the opposing second side of the first adhesive first adhesive and the release liner. Rather, the claims merely requires that the release liner be “positioned against” the opposing second side of the first adhesive. This includes the presence of an intervening layer or structure between the release liner and the opposing second side of the first adhesive. Therefore, Kirson still teaches the scope of the limitations as currently claimed.
5. In response to B), Applicant’s argument with respect to claim 16 has been fully considered and is persuasive. Therefore, the rejection of claims 16-20 have been withdrawn.
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 11-14 are rejected under 35 U.S.C 103 as being unpatentable over Kirson et al. (US Pub.: 2020/0171297 A1 – Previously Cited) and further in view of Eckhouse et al. (US Pub.: 2013/0226269 A1 – Previously Cited).
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), wherein the first adhesive has a first side and an opposing second side (122), wherein the first side faces the support layer (122) (e.g. paragraphs 0046-0047);
a release liner (140) positioned against the opposing second side of the first adhesive (122);
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 and an opposing second side, the first side of the at least one replaceable adhesive subassembly facing the support layer (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]), wherein the release liner (140) positioned against the opposing second side of the first adhesive (122) is a second release liner (e.g. paragraph 0056 – two-part release liner).
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), wherein the first adhesive has a first side and an opposing second side (122), wherein the first side faces the support layer (122) (e.g. paragraphs 0046-0047);
a release liner (140) positioned against the opposing second side of the first adhesive (122);
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 and an opposing second side, the first side of the biocompatible conductive adhesive 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]), wherein the release liner (140) positioned against the opposing second side of the first adhesive (122) is a second release liner (140) (e.g. paragraph 0056).
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 – Previously Cited).
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 – Previously Cited) (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).
Allowable Subject Matter
Claims 16-20 are allowed. The applicant is advised that no prior art was found teaching individually, or suggesting in combination claims 16-20. The closest prior art that is made of record is Kirson et al. (US Pub.: 2020/0171297 A1). In particular Kirson is directed towards a transducer array with enhanced flexibility and adhesion for delivering tumor-treating fields. However, the prior art taken alone or in combination does not teach or disclose “removing one or more of the at least one replaceable adhesive subassembly from the electrode assembly” when taken in the context of claim 16.
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 DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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