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 Group I and the following species:from Group A: Embodiment 3from Group B: Embodiment 5from Group C: Embodiment 6from Group D: N/A (Embodiment with dielectric material was not selected)from Group E: Embodiment 10in the reply filed on 8/5/2025 is acknowledged. Thus, claims 1, 3-5, 9-10, 12, 14, and 16 are pending. Claims 2, 6-8, 11, 13, 15 and 17-20 are withdrawn from consideration.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, 3-4, 12, and 16 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.
Bogie, in a same field of endeavor of electrode stimulation devices, discloses a skin contact layer comprising a biocompatible conductive adhesive (e.g. paragraph 0116, – silver conductive epoxy adhesive.). 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. Furthermore, it would have been obvious to a person having ordinary skill in the art at the time of filing to provide a biocompatible adhesive for the skin contacting layer in order to prevent undesirable reactions on/in the patient’s skin.
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 apparatus of Van to include a biocompatible 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 3, Van in view of Bogie teaches the apparatus of claim 1 as discussed above, and Bogie further teaches wherein the biocompatible conductive adhesive of the skin contact layer is a non-hydrogel conductive adhesive (silver conductive epoxy adhesive is not a hydrogel).
Regarding claim 4, Van in view of Bogie teaches the apparatus of claim 3 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 3 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]).
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).
6. 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).
Conclusion
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/D.T./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792