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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Shaniderman et al. (hereinafter ‘Shnaiderman’, U.S. PGPub No. 2023/0065587).
In regards to claim 1, Shnaiderman discloses an apparatus comprising an electrode subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface (see [0047]), and a dielectric layer on the skin-facing side of the at least one electrode element, wherein the dielectric layer has a dielectric constant of at least 10 and comprises at least one polymer, wherein the electrode subassembly comprises a skin-facing surface and wherein the dielectric layer provides the skin-facing surface of the electrode subassembly ([0048]: "The conductive adhesive composite can include a dielectric material and conductive particles dispersed within the dielectric material. The at least one electrode element is electrically coupled to the skin contact layer.", [0103]: "Accordingly, it should be understood that, in all embodiments disclosed herein, the dielectric material 310 referred to and shown in the drawings as ceramic can be any suitable dielectric material (for example, a polymer layer having a dielectric constant of at least 10, or another material having a dielectric constant of at least 10).", [0169]: "Thus, the second electrode element E2 includes a second layer of dielectric (e.g., ceramic) material 310 having a front face and a rear face, and a second layer of metal 320 disposed on the rear face of the second layer of dielectric material 310. The front face of the second layer of dielectric material 310 is the second front face of the second electrode element E2. Each electrode element can have a skin-facing surface 52."), and a skin contact subassembly coupled to the electrode subassembly, wherein the skin contact subassembly comprises a skin contact conductive adhesive or gel configured to contact skin of a subject, wherein the skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is disposed against the skin-facing surface of the electrode subassembly ([0148]: "In these aspects, the at least one electrode element 300 of the first electrode assembly can be electrically coupled to (optionally, in electrical contact with) the outwardly facing surface of the layer of anisotropic material 70, and the skin contact layer 160 (or skin contact structure 61 (FIGS. 17-21)) of the first electrode assembly can be disposed on the skin-facing side of the layer of anisotropic material, optionally, on the skin-facing surface of the layer of anisotropic material....In these aspects, it is contemplated that the material of the conductive layer 80 can optionally be a conductive adhesive composite as disclosed herein.), and wherein the skin contact subassembly is releasably coupled to the electrode subassembly ([0047]: "In various embodiments, an apparatus can include: at least one electrode element having a skin-facing surface (or “front face”); a layer of anisotropic material having a skin-facing surface and an opposing outwardly facing surface (or “rear face”); and a skin contact layer formed at least partially of a conductive adhesive composite.", [0156]: "Optionally, in exemplary aspects, the skin contact layer can be releasably connected to the layer of anisotropic material.").
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.
Claim(s) 2-4, 6-7, 9, and 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shnaiderman in view of Wasserman et al. (hereinafter ‘Wasserman’, U.S. PGPub No. 2022/0288405).
In regards to claims 2-3, Shnaiderman discloses the invention substantially as described above in claim 1.
Shnaiderman further discloses the polymer of the dielectric layer comprises particles dispersed therethrough of a dielectric layer ([0048]: "The conductive adhesive composite can include a dielectric material and conductive particles dispersed within the dielectric material.").
However, Shnaiderman does not disclose that the particles dispersed therethrough are configured to provide an increased dielectric constant of the dielectric layer or that the particles dispersed through the dielectric layer comprise one or more of barium titanate (BaTiO3), strontium titanate (SrTiO3), barium strontium titanate (BaSrTiO3), calcium copper titanate (CaCuTiO3 or CaCu3Ti4O12), titanium dioxide (TiO2), zirconium dioxide (ZrO2), and empirical formula modifications thereof.
Wasserman teaches use of adding nanoparticles such as barium titanate and barium strontium titanate to improve a dielectric layer’s capacitance ([0065]: "Optionally, ceramic nanoparticles may be mixed into the Poly(VDF-TrFE- CtFE) and/or Poly(VDF-TrFE-CFE) to form a “nanocomposite.” Optionally, these ceramic nanoparticles may comprise ferroelectric metal oxides (e.g., at least one of barium titanate and barium strontium titanate).", [0066]: "In alternative embodiments, instead of forming the polymer regions 30 from Poly(VDF-TrFE-CtFE) and/or Poly(VDF-TrFE-CFE), a different polymer that provides a high level of capacitance may be used.", [0067]: "Examples of alternative polymers that may be used in place of Poly(VDF- TrFE-CtFE) and/or Poly(VDF-TrFE-CFE) include the following: (1) ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF, or other polymers; and (2) barium titanate and/or barium strontium titanate ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF (where Poly(VDF-TrFE), P(VDF-HFP) and PVDF are, respectively, poly(vinylidene fluoride-trifluoroethylene), poly(vinylidene fluoride- hexafluoropropylene), and polyvinylidene fluoride)."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to add particles such as barium titanate or barium strontium titanate into a dielectric layer, as taught by Wasserman, as doing so would improve the capacitance and thus the dielectric constant of the dielectric layer ([0043]: "The capacitance of any given ceramic element is...(b) proportional to the dielectric constant of the ceramic element…").
In regards to claim 4, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the at least one polymer of the dielectric layer is or comprises a rubber or elastomer ([0104]: "In some embodiments, the layer of dielectric material 310 can have a dielectric constant ranging from 10 to 50,000. In some embodiments, the layer of dielectric material 310 comprises a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and/or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene).").
In regards to claim 6, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the dielectric layer is a single continuous layer (Fig. 3B and 10B, [0143]: "Generally, it should be understood that the first and second electrode assemblies 150a can be embodied by any of the electrode assemblies described herein, including the embodiments with reference to FIGS. 3A, 3B, 5-8, 10A-15, and 17-21.").
In regards to claim 7, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the dielectric layer comprises discontinuous portions, each portion disposed on the skin-facing surface of each electrode element of the at least one electrode element (Fig. 3A, [0143]: "Generally, it should be understood that the first and second electrode assemblies 150a can be embodied by any of the electrode assemblies described herein, including the embodiments with reference to FIGS. 3A, 3B, 5-8, 10A-15, and 17-21.", [0211]: "Aspect 13. The apparatus of any one of the preceding aspects, wherein the at least one electrode element comprises a dielectric layer having a skin-facing surface and an outwardly facing surface, and a layer of metal disposed on the outwardly facing surface of the dielectric layer.").
In regards to claim 9, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the electrode subassembly further comprises an adhesive layer or an adhesive structure positioned between the at least one electrode element and the dielectric layer ([0008]: "In some embodiments of the first apparatus, the first electrode element comprises (i) a first layer of dielectric material having a front face and a rear face and (ii) a first layer of metal disposed on the rear face of the first layer of dielectric material. The front face of the first layer of dielectric material is the first front face of the first electrode element. These embodiments further comprise a first layer of conductive material positioned between the first front face of the first electrode element and the rear face of the sheet, wherein the first layer of conductive material facilitates the electrical contact between the first front face of the first electrode element and the rear face of the sheet....Alternatively, the first layer of conductive material may comprise a conductive adhesive composite as further disclosed herein.").
In regards to claim 12, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the skin facing surface of the electrode subassembly is smooth and not tacky, and wherein the skin contact subassembly contacts the skin facing surface of the electrode subassembly ([0170]: "The electrode assembly 50a further includes a first layer of conductive material 80 positioned between the first front face of the first electrode element E1 (i.e., the front face (skin-facing surface) of the first layer of dielectric material 310) and the rear face of the sheet 70. The first layer of conductive material 80 facilitates the electrical contact between the first front face of the first electrode element E1 and the rear face of the sheet 70. In the illustrated embodiment, the layer of conductive material 80 can be a layer of hydrogel." [0147]: "Optionally, as shown in FIG. 16, the skin-facing surface 305 of the at least one electrode element 300 of the first electrode assembly can be in electrical contact with the skin contact layer 160 (or skin contact structure 61 (FIGS. 17-21)) of the first electrode assembly.").
In regards to claim 13, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the skin contact subassembly further comprises a layer of anisotropic conductive material ([0121]: " In other embodiments, the sheet of anisotropic material 70 is a sheet of another conductive anisotropic material.", [0122]: "The front layer of conductive material 60 (or skin contact structure 61 (FIGS. 17-21)) is configured to ensure good electrical contact between the device and the body. In a preferred embodiment, the front layer of conductive material 60 should cover the entire front face of the sheet of anisotropic material 70.").
In regards to claim 14, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 13.
Shnaiderman further discloses that the layer of anisotropic conductive material has a skin-facing side with a skin-facing surface and an opposing outwardly facing surface, wherein the layer of anisotropic conductive material is disposed in contact with the skin contact conductive adhesive or gel, and wherein the at least one electrode element is in electrical contact with the outwardly facing surface of the layer of anisotropic conductive material when the electrode subassembly is in contact with the skin contact subassembly ([0007]: "The first apparatus comprises a sheet of anisotropic material, a skin contact layer comprising a conductive adhesive composite, and a first electrode element. The sheet of anisotropic material has a front face (also referred to herein as a “skin-facing surface”) and a rear face (also referred to herein as an “outwardly facing surface”). The sheet has a first thermal conductivity in a direction that is perpendicular to the front face, and thermal conductivity of the sheet in directions that are parallel to the front face is more than two times higher than the first thermal conductivity.", [0148]: "Optionally, as shown in FIGS. 9 and 10A-14, it is contemplated that the first electrode assembly of the FIG. 16 embodiment can further comprise a layer of anisotropic material 70 having a skin-facing surface and an opposing outwardly facing surface (not shown). In these aspects, the at least one electrode element 300 of the first electrode assembly can be electrically coupled to (optionally, in electrical contact with) the outwardly facing surface of the layer of anisotropic material 70, and the skin contact layer 160 (or skin contact structure 61 (FIGS. 17-21)) of the first electrode assembly can be disposed on the skin-facing side of the layer of anisotropic material, optionally, on the skin-facing surface of the layer of anisotropic material.").
In regards to claim 15, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 13.
Shnaiderman further discloses that the skin contact subassembly comprises a three layer unit comprising the skin contact conductive adhesive or gel, the layer of anisotropic conductive material, and a second conductive adhesive or gel layer, wherein the layer of anisotropic conductive material has a skin facing side with a skin facing surface and an opposing outwardly facing surface and wherein the skin facing surface of the layer of anisotropic conductive material is in contact with the skin contact conductive adhesive or gel, and the outwardly facing surface of the layer of anisotropic conductive material is in contact with the second conductive adhesive or gel layer ([0172]: "The outer adhesive layer 62 can be disposed on a skin-facing side 76 of the layer of anisotropic material 70). The inner adhesive layer 64 can be configured to contact skin of a subject. Optionally, the outer adhesive layer 62 of the skin contact structure 61 can be disposed on the skin-facing surface 72 of the layer of anisotropic material.", [0229]: "Aspect 31. The apparatus of any one of the preceding aspects, further comprising an upper adhesive layer comprising conductive adhesive composite wherein the upper adhesive layer is disposed on an outwardly facing side of the layer of anisotropic material.").
In regards to claim 16, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 13.
Shnaiderman further discloses that the layer of anisotropic conductive material is or comprises graphite ([0088]: "In some embodiments (e.g., when the sheet of anisotropic material is a sheet of pyrolytic graphite), the sheet of anisotropic material has both anisotropic electrical properties and anisotropic thermal properties.").
In regards to claim 17, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the electrode subassembly further comprises a layer of anisotropic conductive material ([0084]: "Optionally, the embodiments described herein incorporate into the electrode assembly a sheet of material having anisotropic thermal properties and/or anisotropic electrical properties, as described below.", [0085]: "In some preferred embodiments, the anisotropic material is anisotropic with respect to both electrical conductivity properties and thermal conductivity properties.").
In regards to claim 18, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses a method of using the apparatus of claim 2, the method comprising: removing the skin contact subassembly from the electrode subassembly ([0050]: "Each of the first and second electrode assemblies comprising at least one electrode element having a skin-facing surface, a layer of anisotropic material having a skin-facing surface and an opposing outwardly facing surface, and a skin contact structure.", [0156]: "Optionally, in exemplary aspects, the skin contact layer can be releasably connected to the layer of anisotropic material.").
In regards to claim 19, Shnaiderman/Wasserman combination discloses the invention substantially as described above in claim 18.
Shnaiderman further discloses positioning a new skin contact subassembly against the skin-facing surface of the electrode subassembly so that the new skin contact subassembly is removably coupled to the electrode subassembly ([0156]: "Optionally, in exemplary aspects, the skin contact layer can be releasably connected to the layer of anisotropic material. In these aspects, it is contemplated that the skin contact layer can be selectively detached from the anisotropic material and replaced with a new skin contact layer (for example, when a maximum/threshold duration of use is approached or met).").
Claim(s) 5, 10-11, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shnaiderman in view of Wasserman and in further view of Wang et al. (hereinafter ‘Wang’, U.S. PGPub No. 2020/0316366).
In regards to claim 5, Shaniderman/Wasserman combination discloses the invention substantially as described above in claim 2.
However, Shaniderman/Wasserman combination does not disclose that the at least one polymer of the dielectric layer is or comprises a silicone rubber or a silicone elastomer.
Wang teaches a wearable medical device which uses a silicone rubber in a dielectric layer ([0075]: "In one embodiment the lower dielectric film 76 is polytetrafluoroethylene (PTFE) but may also be other tribo-negative materials such as polydimethylsiloxane (PDMS), polyethylene, polypropylene, vinyl (PVC), silicon, silicone rubber, ebonite and the like known in the art."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to use silicone rubber in the dielectric layer, as taught by Wang, as doing so would provide more negative charge for the dielectric layer ([0075]: "The stationary polymer sheet 72 may include a thin layer of flexible polyethylene terephthalate (PET) substrate having a tribo-negative dielectric film 76 of triboelectrically negative dielectric material contacting the freestanding polymer sheet 70 and is a material that will obtain a more negative charge when touched with another material.").
In regards to claim 10, Shaniderman/Wasserman combination discloses the invention substantially as described above in claim 9.
Shnaiderman further discloses that the adhesive layer or adhesive structure comprises a conductive silicone adhesive ([0102]: "In some embodiments, the at least one layer of conductive material 60 is a single layer of non-hydrogel biocompatible conductive adhesive...The adhesive polymer may be, for example, an acrylic polymer or a silicone polymer, or combination thereof, which may be available as acrylic- or silicone-based carbon-filled adhesive tapes.", [0104]: "In some embodiments, the layer of dielectric material 310 can have a dielectric constant ranging from 10 to 50,000. In some embodiments, the layer of dielectric material 310 comprises a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and/or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene).").
However, Shaniderman/Wasserman combination does not disclose that the at least one polymer of the dielectric layer is or comprises a silicone rubber or a silicone elastomer.
Wang teaches a wearable medical device which uses a silicone rubber in a dielectric layer ([0075]: "In one embodiment the lower dielectric film 76 is polytetrafluoroethylene (PTFE) but may also be other tribo-negative materials such as polydimethylsiloxane (PDMS), polyethylene, polypropylene, vinyl (PVC), silicon, silicone rubber, ebonite and the like known in the art."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to use silicone rubber in the dielectric layer, as taught by Wang, as doing so would provide more negative charge for the dielectric layer ([0075]: "The stationary polymer sheet 72 may include a thin layer of flexible polyethylene terephthalate (PET) substrate having a tribo-negative dielectric film 76 of triboelectrically negative dielectric material contacting the freestanding polymer sheet 70 and is a material that will obtain a more negative charge when touched with another material.").
In regards to claim 11, Shaniderman/Wasserman combination discloses the invention substantially as described above in claim 2.
Shnaiderman further discloses that the electrode subassembly further comprises a conductive layer comprising a silicone polymer ([0102]: "In some embodiments, the at least one layer of conductive material 60 is a single layer of non-hydrogel biocompatible conductive adhesive...The adhesive polymer may be, for example, an acrylic polymer or a silicone polymer, or combination thereof, which may be available as acrylic- or silicone-based carbon-filled adhesive tapes.", [0104]: "In some embodiments, the layer of dielectric material 310 can have a dielectric constant ranging from 10 to 50,000. In some embodiments, the layer of dielectric material 310 comprises a high dielectric polymer material such as poly(vinylidene fluoride-trifluoroethylene-chlorotrifluoroethylene) and/or poly(vinylidene fluoride-trifluoroethylene-1-chlorofluoroethylene).").
However, Shaniderman/Wasserman combination does not disclose that the at least one polymer of the dielectric layer is or comprises a silicone rubber or a silicone elastomer.
Wang teaches a wearable medical device which uses a silicone rubber in a dielectric layer ([0075]: "In one embodiment the lower dielectric film 76 is polytetrafluoroethylene (PTFE) but may also be other tribo-negative materials such as polydimethylsiloxane (PDMS), polyethylene, polypropylene, vinyl (PVC), silicon, silicone rubber, ebonite and the like known in the art."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to use silicone rubber in the dielectric layer, as taught by Wang, as doing so would provide more negative charge for the dielectric layer ([0075]: "The stationary polymer sheet 72 may include a thin layer of flexible polyethylene terephthalate (PET) substrate having a tribo-negative dielectric film 76 of triboelectrically negative dielectric material contacting the freestanding polymer sheet 70 and is a material that will obtain a more negative charge when touched with another material.").
In regards to claim 20, Shnaiderman discloses an apparatus comprising an electrode subassembly comprising at least one electrode element having a skin-facing side and a skin-facing surface (see [0047]), and a dielectric layer on the skin-facing side of the at least one electrode element, wherein the dielectric layer has a dielectric constant of at least 10 and comprises at least one polymer, wherein the electrode subassembly comprises a skin-facing surface and wherein the dielectric layer provides the skin-facing surface of the electrode subassembly ([0048]: "The conductive adhesive composite can include a dielectric material and conductive particles dispersed within the dielectric material. The at least one electrode element is electrically coupled to the skin contact layer.", [0103]: "Accordingly, it should be understood that, in all embodiments disclosed herein, the dielectric material 310 referred to and shown in the drawings as ceramic can be any suitable dielectric material (for example, a polymer layer having a dielectric constant of at least 10, or another material having a dielectric constant of at least 10).", [0169]: "Thus, the second electrode element E2 includes a second layer of dielectric (e.g., ceramic) material 310 having a front face and a rear face, and a second layer of metal 320 disposed on the rear face of the second layer of dielectric material 310. The front face of the second layer of dielectric material 310 is the second front face of the second electrode element E2. Each electrode element can have a skin-facing surface 52."), and a skin contact subassembly coupled to the electrode subassembly, wherein the skin contact subassembly comprises a skin contact conductive adhesive or gel configured to contact skin of a subject, wherein the skin contact conductive adhesive or gel is electrically coupled to the at least one electrode element when the skin contact subassembly is disposed against the skin-facing surface of the electrode subassembly ([0148]: "In these aspects, the at least one electrode element 300 of the first electrode assembly can be electrically coupled to (optionally, in electrical contact with) the outwardly facing surface of the layer of anisotropic material 70, and the skin contact layer 160 (or skin contact structure 61 (FIGS. 17-21)) of the first electrode assembly can be disposed on the skin-facing side of the layer of anisotropic material, optionally, on the skin-facing surface of the layer of anisotropic material....In these aspects, it is contemplated that the material of the conductive layer 80 can optionally be a conductive adhesive composite as disclosed herein.), and wherein the skin contact subassembly is releasably coupled to the electrode subassembly ([0047]: "In various embodiments, an apparatus can include: at least one electrode element having a skin-facing surface (or “front face”); a layer of anisotropic material having a skin-facing surface and an opposing outwardly facing surface (or “rear face”); and a skin contact layer formed at least partially of a conductive adhesive composite.", [0156]: "Optionally, in exemplary aspects, the skin contact layer can be releasably connected to the layer of anisotropic material.").
However, Shnaiderman does not disclose that comprises a silicone rubber or elastomer having particles dispersed therethrough that are configured to provide an increased dielectric constant of the dielectric layer.
Wasserman teaches use of adding nanoparticles such as barium titanate and barium strontium titanate to improve a dielectric layer’s capacitance ([0065]: "Optionally, ceramic nanoparticles may be mixed into the Poly(VDF-TrFE- CtFE) and/or Poly(VDF-TrFE-CFE) to form a “nanocomposite.” Optionally, these ceramic nanoparticles may comprise ferroelectric metal oxides (e.g., at least one of barium titanate and barium strontium titanate).", [0066]: "In alternative embodiments, instead of forming the polymer regions 30 from Poly(VDF-TrFE-CtFE) and/or Poly(VDF-TrFE-CFE), a different polymer that provides a high level of capacitance may be used.", [0067]: "Examples of alternative polymers that may be used in place of Poly(VDF- TrFE-CtFE) and/or Poly(VDF-TrFE-CFE) include the following: (1) ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF, or other polymers; and (2) barium titanate and/or barium strontium titanate ceramic nanoparticles mixed into at least one of Poly(VDF-TrFE), P(VDF-HFP), PVDF (where Poly(VDF-TrFE), P(VDF-HFP) and PVDF are, respectively, poly(vinylidene fluoride-trifluoroethylene), poly(vinylidene fluoride- hexafluoropropylene), and polyvinylidene fluoride)."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to add particles such as barium titanate or barium strontium titanate into a dielectric layer, as taught by Wasserman, as doing so would improve the capacitance and thus the dielectric constant of the dielectric layer ([0043]: "The capacitance of any given ceramic element is...(b) proportional to the dielectric constant of the ceramic element…").
Wang teaches a wearable medical device which uses a silicone rubber in a dielectric layer ([0075]: "In one embodiment the lower dielectric film 76 is polytetrafluoroethylene (PTFE) but may also be other tribo-negative materials such as polydimethylsiloxane (PDMS), polyethylene, polypropylene, vinyl (PVC), silicon, silicone rubber, ebonite and the like known in the art."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to use silicone rubber in the dielectric layer, as taught by Wang, as doing so would provide more negative charge for the dielectric layer ([0075]: "The stationary polymer sheet 72 may include a thin layer of flexible polyethylene terephthalate (PET) substrate having a tribo-negative dielectric film 76 of triboelectrically negative dielectric material contacting the freestanding polymer sheet 70 and is a material that will obtain a more negative charge when touched with another material.").
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shnaiderman in view of Wasserman and in further view of Wasserman et al. (hereinafter ‘Wasserman 22', U.S. PGPub No. 2022/0288405).
In regards to claim 8, Shaniderman/Wasserman combination discloses the invention substantially as described above in claim 2.
However, Shaniderman/Wasserman combination does not disclose that the electrode subassembly further comprises a circuit board, wherein the at least one electrode element is coupled to the circuit board, wherein the dielectric layer and the circuit board cooperate to encapsulate the at least one electrode element.
Wasserman 22 teaches an electrode array which produces electric fields which includes an electrode subassembly includes a circuit, with an electrode element which is coupled to the circuit is encapsulated by the dielectric material and the circuit ([0068]: "The flex circuit 102 includes a number of mounting pads 104 arranged along the rows 106a-106e. A number of electrode elements 110 (FIGS. 3A and 3C)—for example, twenty as shown in the FIG. 3A embodiment for a typically sized adult male—are disposed on the inner (i.e., skin-facing) side of the mounting pads 104 of the flex circuit 102 (shown in FIGS. 3A and 3B) with an electrically conductive connection between each of the electrode elements 110 and the flex circuit 102....Each of the electrode elements 110 may be formed from a circular conductive plate that is coated with a ceramic dielectric material as is known in the art, and the circular conductor is electrically connected to an electrical contact of the flex circuit 102."). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the electrode assembly to include a circuit in the electrode assembly and encapsulate an electrode element with a circuit and dielectric material, as taught by Wasserman 22, as doing so would allow the dielectric material to be able to make contact with the skin ([0068]: "The ceramic dielectric material faces toward the patient's body so that the ceramic dielectric material can make contact with the patient's skin (preferably via an intervening layer of hydrogel, as described below). The dielectric material may be a ceramic material, a non-flexible polymer, or a flexible polymer film.") while allowing some amount of flexibility through a flex circuit which could allow for placement on the body of a subject where electric field therapy is needed, while protecting the electrode elements ([0069]: "In general, the stiffeners 112 help prevent the electrode elements 110 from breaking, given the flexible nature of the flex circuit 102 and the thin, fragile nature of the ceramic dielectric used for the electrode elements 110.").
Conclusion
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/B.M.L./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
