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 6/1/2026. Claims 1, 4, 12 have been amended. Claims 21-23 were newly added. Claims 2-3 and 17-20 have been canceled.
Response to Arguments
3. Applicant’s arguments filed on 6/1/2026 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues that A) Van Der Beek does not teach anisotropic material and B) The combination of Van Der Beek and Bogie does not teach or suggest “the biocompatible conductive adhesive of the skin contact layer is a non-hydrogel conductive adhesive” and C) The combination of Van Der Beek and Bogie does not teach the newly added claims 21-23.
4. In response to A), the examiner respectfully disagrees.
Van Der Beek discloses in paragraph 0030 that current spreader 36 is made of graphitized cloth or wire mesh. Graphite is a well-known anisotropic material. This is evidenced by at least Asbury Advanced Materials (NPL reference, “Anisotropy | Graphite 101”, published 2019; see pages 1-2). Therefore, Van Der Beek still meets the scope of the limitations as currently claimed.
5. In response to B), the examiner respectfully disagrees.
Van Der Beek, the primary reference, was relied upon to teach a skin contact layer (34) comprising a conductive adhesive as disclosed in paragraph 0030. Bogie, the secondary reference, was relied upon to teach silver conductive epoxy adhesive which is a biocompatible conductive adhesive that is a non-hydrogel conductive adhesive (see paragraphs 0116, 0118). Applicant is reminded to view the rejection as a whole. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
6. In response to C), the examiner respectfully disagrees and directs applicant to the art rejections below for the newly added claims.
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.
Claim 22 is 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.
Claim 22 recites “wherein the at least one electrode element comprises a plurality of electrode elements”. It is unclear how a single electrode element can comprise a plurality of itself. Therefore, the claim is indefinite. For the purposes of examination, this limitation will be interpreted as the one electrode element having sub-elements.
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, 4, 12, 16, and 22-23 are rejected under 35 U.S.C 103 as being unpatentable over Van Der Beek et al. (US Pub.: 2013/0066412 A1, hereafter referred to as “Van”) and further in view of Bogie et al. (US Pub.: 2023/0158293 A1).
Regarding claim 1, Van teaches an apparatus comprising:
at least one electrode element (72) having a skin-facing surface (72 has one side that faces the skin);
a layer of anisotropic material (36) (e.g. Fig. 12 – current spreader 36 distributes electrical signals in an anisotropic manner; paragraph 0030) having a skin-facing surface and an opposing outwardly facing surface (e.g. Fig. 12);
a first layer of non-hydrogel conductive adhesive (second conductive layer (74), [0045]) positioned between the skin-facing surface of the at least one electrode element and the outwardly facing surface of the layer of anisotropic material (e.g. Fig. 12);
a skin contact layer (34) comprising a conductive adhesive [0030], wherein the skin contact layer is disposed on a skin-facing side of the layer of anisotropic material (e.g. Fig. 12 – conductive gel layer 34; current spreader 36);
wherein the first layer of non-hydrogel conductive adhesive (74) facilitates electrical contact ([0045-0046]) between the skin-facing surface (72) of the at least one electrode element and the outwardly facing surface of the layer of anisotropic material (36), ([0038], [0045-0046]).
However, Van does not explicitly teach that the conductive adhesive of the skin contact layer is a biocompatible conductive adhesive, wherein the biocompatible conductive adhesive of the skin contact layer is a non-hydrogel conductive adhesive.
Bogie, in a same field of endeavor of electrode stimulation devices, discloses a skin contact layer comprising a biocompatible conductive adhesive, wherein the biocompatible conductive adhesive of the skin contact layer is a non-hydrogel conductive adhesive (e.g. paragraph 0116, – silver conductive epoxy adhesive is biocompatible and is not a hydrogel). It would have been obvious to a person having ordinary skill in the art at the time of filing to provide a biocompatible adhesive, wherein the biocompatible conductive adhesive of the skin contact layer is a non-hydrogel conductive adhesive, for the skin contacting layer in order to prevent undesirable reactions on/in the patient’s skin.
Additionally, 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 apparatus of Van to include a biocompatible conductive adhesive, wherein the biocompatible conductive adhesive of the skin contact layer is a non-hydrogel conductive adhesive, 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 contact with the skin.
Regarding claim 4, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, wherein the non-hydrogel conductive adhesive (silver conductive epoxy of Bogie [0116]) of the skin contact layer differs from the non-hydrogel conductive adhesive of the first layer of non-hydrogel conductive adhesive of Van (74).
Regarding claim 12, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, and Bogie further teaches wherein either, or both, of the first layer of non-hydrogel conductive adhesive or the biocompatible conductive adhesive of the skin contact layer further comprises a polar material (e.g. paragraph 0116, – silver conductive epoxy is polar).
Regarding claim 16, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, and Van further teaches wherein the skin contact layer (conductive gel layer (34)) is disposed on the skin-facing surface of the layer of anisotropic material (36) (See Fig. 12 showing (0036) which inserts into (78) and thereby contacts (34) in the claimed manner; [0045]).
Regarding claim 22, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, and Van further teaches wherein the at least one electrode element (72) comprises a plurality of electrode elements (e.g. paragraph 0044, – metal plate 72 can further include a magnet as well as ferromagnetic material).
Regarding claim 23, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, and Van further teaches wherein the skin contact layer (34) has an outer perimeter (e.g. paragraph 0030), wherein the anisotropic material (36) has an outer perimeter (e.g. paragraph 0030), and wherein the outer perimeter of the anisotropic material overlies the outer perimeter of the skin contact layer (e.g. paragraph 0030).
Claims 5, 9, and 10 are rejected under 35 U.S.C 103 as being unpatentable over Van and further in view of Bogie and further in view of Shown et al. (NPL reference, “Fabrication of carbon microcoil/polyaniline composite… for electrochemical functional enhancement”, published January, 2012).
Regarding claim 5, Van in view of Bogie teaches the apparatus of claim 1 as discussed above. Van teaches the first layer of non-hydrogel conductive adhesive (74). However, Van in view of Bogie does not explicitly teach wherein the first layer of non-hydrogel conductive adhesive comprises a material that facilitates electrical conductivity in a z-direction that is perpendicular to a plane of the layer of anisotropic material.
Shown, in a same field of endeavor of electrode devices, discloses wherein the first layer of non-hydrogel conductive adhesive comprises a material that facilitates electrical conductivity in a z-direction that is perpendicular to a plane of the layer of anisotropic material (e.g. pg. 380, Introduction Heading – carbon microcoil).
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 Van and Bogie to include a material that facilitates electrical conductivity in a z-direction that is perpendicular to a plane of the layer of anisotropic material (i.e. carbon microcoil), as taught and suggested by Shown, in order to enhance the conductivity properties of the electrode as well as making the electrode lighter (e.g. pg. 381, left column, first paragraph).
Regarding claim 9, Van in view of Bogie in view of Shown teaches the apparatus of claim 5 as discussed above, and Shown further teaches wherein the material that facilitates electrical conductivity in the z-direction that is perpendicular to a plane of the layer of anisotropic material is a conductive material having 3D carbon structures (e.g. pg. 380, Introduction Heading – carbon microcoil have 3D carbon structures).
Regarding claim 10, Van in view of Bogie in view of Shown teaches the apparatus of claim 9 as discussed above, and Shown further teaches wherein the material that facilitates electrical conductivity in the z-direction is carbon microcoils (e.g. pg. 380, Introduction Heading – carbon microcoil have 3D carbon structures).
12. Claim 14 is rejected under 35 U.S.C 103 as being unpatentable over Van and further in view of Bogie and further in view of Imran et al. (US Pub.: 2010/0331811 A1).
Regarding claim 14, Van in view of Bogie teaches the apparatus of claim 1 as discussed above. However, Van in view of Bogie does not explicitly teach wherein the layer of anisotropic material has: i) a first thermal conductivity in a direction that is perpendicular to a plane of the layer, and wherein thermal conductivity of the layer in directions that are parallel to the plane of the layer is more than two times higher than the first thermal conductivity; or ii) a first resistance in a direction that is perpendicular to a plane of the layer, and wherein resistance of the layer in directions that are parallel to the plane of the layer is less than half the first resistance; or iii) a combination of i) and ii).
Imran, in a same field of endeavor of electrode devices, discloses wherein the layer of anisotropic material has: i) a first thermal conductivity in a direction that is perpendicular to a plane of the layer, and wherein thermal conductivity of the layer in directions that are parallel to the plane of the layer is more than two times higher than the first thermal conductivity (e.g. Fig. 2 – pyrolytic graphene electrode 40; paragraph 0034, – pyrolytic graphite is a unique form of graphite manufactured by decomposition of a hydrocarbon gas at very high temperature in a vacuum furnace. The result is an ultra-pure product which is near theoretical density and extremely anisotropic).
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 Van and Bogie to incorporate the anisotropic pyrolytic graphite layer, as taught and suggested by Imran, in order to allow for the electrical conduction through the electrode, but also provide for thermal insulation in one or more directions (Imran, paragraph 0034).
13. Claim 21 is rejected under 35 U.S.C 103 as being unpatentable over Van and further in view of Bogie and further in view of Palti et al. (US Pub.: 2013/0178820 A1).
Regarding claim 21, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, and Van further teaches wherein the apparatus is configured to cooperate with a current generator (e.g. paragraph 0004 – the electrode also includes a connector assembly configured to electrically connect the electrode to an external electrical apparatus to transfer electrical signals between the subject's skin and the external electrical apparatus). Additionally, Van further teaches providing electrical stimulation non-invasively for a multitude of treatments (e.g. paragraph 022). However, Van in view of Bogie does not explicitly teach to provide tumor-treating fields at a frequency from 50kHz to 1MHz.
Palti, in a same field of endeavor of electrical stimulation, discloses to provide tumor-treating fields at a frequency from 50kHz to 1MHz (e.g. see Fig. 11; paragraph 0026, – 50 KHz to 500 KHz; paragraph 0043).
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 Van and Bogie to incorporate providing tumor-treating fields at a frequency from 50kHz to 1MHz, as taught and suggested by Palti, for the purpose of being able to provide additional treatments to a patient such as treating tumors associated with lung cancer (Palti, paragraph 0043).
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.
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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
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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