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 .
Response to Arguments
Claims 1, 9, and 18-20 are amended. Claims 10-11 are canceled. Claims 1-9, 12-22 are pending.
Claim Objections
Applicant’s arguments, filed 11/26/2025, with respect to claims 18-19 have been fully considered and are persuasive. The claim objections to claims 18-19 of 08/26/2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments with respect to claim(s) 1-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, claim 1 includes the previously cited reference Palti (US 20040068297 A1 – hereinafter Palti) used in the claim 20 rejection to teach its electrode elements configured to electrically couple to an AC generator to generate tumor-treating fields (Palti figure 11 shows the AC generator 210 coupled to electrodes 230 to deliver tumor treating fields).
Claim 9 includes the amendment, “…or wherein the layer of anisotropic material has 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”, however the “or” alternative does not expressly require that the prior art teaches these limitations. Claim 9 stands rejected as detailed in the rejection below.
Information Disclosure Statement
The information disclosure statement(s) filed April 11, 2024 has/have been considered by the Examiner.
Claim Interpretation
The term(s) “configured to” in the claim(s) may be interpreted as intended use. Intended use/functional language does not require that references teach or disclose the intended use of an element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP section 2114. II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART.
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.
Claim(s) 1-2, 5-7, and 16-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek) (both cited previously), and in further view of Palti (US 20040068297 A1 – hereinafter Palti).
Re. claim 1, Skiba teaches an apparatus (paragraph 0003 – “Aspects disclosed herein comprise bioelectric devices…”) comprising:
an electrode layer (figure 1, primary surface 2) having:
a plurality of electrode elements, each electrode element of the plurality of electrode elements having a skin-facing surface (figures 1-4, primary surface 2 includes electrodes 6 and 10, along with their repetitions 12),
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wherein at least first and second electrode elements are spaced apart within the electrode layer along a first axis (figure 1 shows the electrodes 6 and 10 (and their repetitions 12) spaced apart along the X-Y axis);
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and at least one filler structure, wherein the at least one filler structure comprises a first filler structure having a first filler portion positioned within a space between the first and second electrode elements (figures 1-4, spacing 8 between the electrodes 6 and 10),
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wherein the at least one filler structure is configured to provide the electrode layer with a substantially consistent height along the first axis (figure 4, spacing 8 and the electrodes 6, 10 all have consistent heights along a first axis of the primary layer 2);
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a layer of anisotropic material having a skin-facing surface and an opposing outwardly facing surface (figure 4, wound dressing layer 22 can be made of cotton, a known anisotropic material; paragraph 0090 – “The back 20 of the printed dressing material is fixed to an absorbent wound dressing layer 22 such as cotton”);
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and a skin contact structure having an adhesive layer (figure 4, anchor 18 with adhesive layer 16; paragraph 0090 – “The absorbent dressing layer is adhesively fixed to an elastic adhesive layer 16 such that there is at least one overlapping piece or anchor 18 of the elastic adhesive layer [16] that can be used to secure the wound management system over a wound”);
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wherein the electrode layer is on the outer side of the layer of anisotropic material (figure 4, primary surface 2 containing electrodes 6 and 10 is on the outer side of the cotton wound dressing layer 22),
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and wherein at least one electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the layer of anisotropic material (figure 4 shows the primary layer 2 comprising the electrodes 6 and 10 adhered to and connected to the outer layer of the anisotropic cotton wound dressing layer 22; paragraph 0090 – “The pattern shown in detail in FIG. 2 is applied to the primary surface 2 of a wound dressing material. The back 20 of the printed dressing material is fixed to an absorbent wound dressing layer 22 such as cotton”),
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and wherein the skin contact structure is disposed on an inner side of the layer of anisotropic material and is configured to contact skin of a subject (figure 4, adhesive 16 is placed on the inner surface of the wound dressing material 22; paragraph 0090 – “The absorbent dressing layer is adhesively fixed to an elastic adhesive layer 16 such that there is at least one overlapping piece or anchor 18 of the elastic adhesive layer [16] that can be used to secure the wound management system over a wound”).
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Skiba teaches the skin contact structure having an adhesive layer as stated above (figure 4, anchor 18 with adhesive layer 16; paragraph 0090 – “The absorbent dressing layer is adhesively fixed to an elastic adhesive layer 16 such that there is at least one overlapping piece or anchor 18 of the elastic adhesive layer [16] that can be used to secure the wound management system over a wound”),
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But Skiba does not explicitly teach a skin contact structure having an adhesive layer comprising a conductive adhesive composite.
Van Der Beek teaches a similar electrode assembly to provide stimulation to a patient’s skin (Van Der Beek abstract – “An electrode assembly that includes an electrode configured to provide electrical contact with a subject's skin…”; paragraph 0001 – “The invention relates to an electrode for use in medical applications (e.g., stimulations and physiological parameters monitoring), and a method of use therefor”). Van Der Beek further teaches, in figure 9, the skin contacting surface 31 comprises a conductive gel layer 34 (Van Der Beek paragraph 0030 – “The gel layer 34 may be conductive and may facilitate the distribution of electric signals between the subject's skin and the electrode 14”) and can include an adhesive material to create a conductive adhesive composite with the gel layer (Van Der Beek paragraph 0030 – “The gel layer 34 may include an adhesive material to facilitate the connection between the electrode 14 and the subject's skin”).
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Skiba and Van Der Beek both teach within the field of electrode apparatuses which contact a subject’s skin to deliver stimulation, with adhesive layers. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive layer 16, as taught by Skiba, to incorporate the conductive gel layer adhesive composite 34 as taught by Van Der Beek since such modification would predictably result in, for example, to facilitate the connection between the electrode(s) and the subject's skin (Van Der Beek paragraph 0030).
The combined invention of Skiba and Van Der Beek (hereinafter the combined invention) also teaches an upper layer disposed on an outer side of the layer of anisotropic material (Skiba figure 4, back layer 20, which is said to be fixed to the outer side of the anisotropic cotton wound dressing layer 22; paragraph 0090 – “The back 20 of the printed dressing material is fixed to an absorbent wound dressing layer 22 such as cotton”).
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The combined invention however does not explicitly teach how the back 20 is fixed, particularly the back 20 being an upper adhesive layer comprising a conductive adhesive composite, wherein the upper adhesive layer is disposed on an outer side of the layer of anisotropic material.
However, it is reminded that “… the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see MPEP 2144.04. VI. B. Duplication of Parts. In the instant case, back layer 20 is said to be fixed to the anisotropic wound dressing 22, as per Skiba paragraph 0090. The conductive gel layer adhesive composite 34 as taught by Van Der Beek is a known adhesive layer which could then be used to fix to the primary layer 2 as the back layer, and further fix to the wound dressing layer 22 to create electrical contact by way of fixation/adherence by the conductive adhesive gel layer 34 as taught by Van Der Beek, which would not produce any new or unexpected result, nor change operation of the apparatus. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the back layer 20, as taught by Skiba of the combined invention, to incorporate a duplicate conductive gel layer adhesive composite 34, as taught by Van Der Beek of the combined invention, since such modification would still predictably result in adhering the primary layer 2 [electrode layer] and wound dressing layer 22 [anisotropic] together in order to facilitate connection between the electrode(s) and the subject's skin (Van Der Beek paragraph 0030).
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The combined invention does not explicitly teach wherein the plurality of electrode elements are configured to electrically couple to an AC generator to generate tumor-treating fields.
Palti discloses a similar electrode apparatus for adhering to skin to deliver stimulation, particularly electric fields (Palti abstract – “The apparatus includes insulated electrodes to be coupled to a generator for subjecting the living tissue to electric field conditions…Preferably, an intervening member is disposed between each insulated electrode and the skin surface…”). Palti further teaches in figure 11, the known technique of providing two electrode assemblies 230 which are coupled to an AC generator 210 and placed on a subject’s body and are used to generate alternating voltages (Palti paragraph 0077 – “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz…”) and thereby creates a tumor-treating electric field between the electrode assemblies (shown in Palti figure 11).
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The combined invention and Palti all teach within the field of electrode apparatuses which contact a subject’s skin to deliver stimulation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode apparatuses and method of the combined invention to incorporate the positioning first and second electrode assemblies on a body of a subject, and delivering alternating voltage to create an electric field as taught by Palti since such modification would predictably result in delivering tumor treating fields to treat desired target tumors, such as in Palti figure 11 (Palti paragraph 0089 – “The arrangement of the isolects 230 in FIG. 11 is particularly useful for treating a tumor 415 associated with lung cancer or gastro-intestinal tumors”).
Re. claim 2, the combined invention of Skiba, Van der Beek and Palti (hereinafter the combined invention) further teaches wherein each electrode element of the plurality of electrode elements is in electrical contact with the outwardly facing surface of the layer of anisotropic material (Skiba figure 4 shows each of the electrodes 6 and 10 are adhered and connected to the outward surface of the cotton wound dressing layer 22 via back 20; paragraph 0090 – “The pattern shown in detail in FIG. 2 is applied to the primary surface 2 of a wound dressing material. The back 20 of the printed dressing material is fixed to an absorbent wound dressing layer 22 such as cotton”).
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Re. claim 5, the combined invention further teaches wherein the plurality of electrode elements further comprises:
a third electrode element, wherein the second electrode element is positioned between, and spaced from the first and third electrode elements along the first axis, (Skiba figure 1 shows eight columns and six rows of electrodes 6, 10 and their repetitions 12, all spaced between spacing 8),
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and wherein the at least one filler structure further comprises a second filler portion positioned between the second and third electrode elements along the first axis (Skiba figure 4 shows the spacings 8 filling the spaces between the electrodes 6 and 10).
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Re. claim 6, the combined invention further teaches wherein the plurality of electrode elements comprises at least:
two rows of electrode elements that extend along or parallel to a second axis that is perpendicular to the first axis, wherein the at least two rows of electrode elements comprises a first row of electrode elements that includes the first electrode element (Skiba figure 1 shows eight columns and six rows of electrodes 6, 10 and their repetitions 12, all spaced between spacing 8), and a second row of electrode elements that includes the second electrode element (Skiba figure 1 shows eight columns and six rows of electrodes 6, 10 and their repetitions 12, all spaced between spacing 8),
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wherein the first filler portion is positioned between the first and second rows of electrode elements along the first axis (Skiba figures 1 and 4 show the spacings 8 filling the spaces between the electrodes 6 and 10).
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Re. claim 7, the combined invention further teaches wherein the plurality of electrode elements comprises at least:
three rows of electrode elements that extend along or parallel to a second axis that is perpendicular to the first axis, wherein the at least three rows of electrode elements comprises a first row of electrode elements that includes the first electrode element (Skiba figure 1 shows eight columns and six rows of electrodes 6, 10 and their repetitions 12, all spaced between spacing 8), a second row of electrode elements that includes the second electrode element, and a third row of electrode elements that includes the third electrode element (Skiba figure 1 shows eight columns and six rows of electrodes 6, 10 and their repetitions 12, all spaced between spacing 8),
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wherein the first filler portion is positioned between the first and second rows of electrode elements, and wherein the second filler portion is positioned between the second and third rows of electrode elements (Skiba figure 4 shows the spacings 8 filling the spaces between rows of the electrodes 6 and 10).
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Re. claim 16, the combined invention further teaches wherein the at least one filler structure comprises a medication (Skiba paragraph 0031 – “…coatings on the surface, such as, for example, over or between the electrodes. Such coatings can include, for example, silicone, and electrolytic mixture, hypoallergenic agents, drugs, biologics, stem cells, skin substitutes or the like. Drugs suitable for use with embodiments of the invention include analgesics, antibiotics, anti-inflammatories, or the like”).
Re. claim 17, the combined invention further teaches wherein the first filler portion has a shape that is complementary to a shape of the space between the first and second electrode elements (Skiba figures 1 and 4 show the spacings 8 accommodating the spaces between electrodes 6 and 10).
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Re. claim 18, the combined invention further teaches wherein the first filler portion and/or the second filler portion is part of a strip of filler structure material that fills the gap between either one or more rows of electrode elements or one or more columns of electrode elements (Skiba figure 1 shows the electrodes 6 and 10 are aligned in a manner which allows the spacings 8 to have strips of space between the electrodes in rows AND columns, with columns shown below).
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Re. claim 19, the combined invention further teaches wherein the first filler portion and the second filler portion are part of a shaped layer of filler structure material that fills the gaps between all of the electrode elements (Skiba figure 1, spacings 8 fills gaps between electrodes 6 and 10).
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The combined invention does not explicitly teach the filler portions having cut-outs as void spaces that receive respective electrode elements of the plurality of electrode elements.
However, it is reminded that the configuration of the filler portions, or the spacings 8 as taught by Skiba of the combined invention would be considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the filler portions is significant, in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), see MPEP 2144.04. B. Changes in Shape. In the instant case, the spacings 8 as taught by Skiba of the combined invention fill the spaces between the electrodes 6 and 10, and would reasonably achieve the same results of filling the spaces between the electrodes 6 and 10 if made into slit cut-out shapes (shown in broken lines below), which would still allow electrodes 6 and 10 to be received in the void spaces.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spacings 8 as taught by Skiba of the combined invention to include, for example, the known shapes of slit cutouts in the spacings as shown above since such modification would still predictably result in allowing ample space in the substrate, or primary surface 2, for the electrodes to be received.
Re. claim 20, the combined invention of Skiba and Van Der Beek (hereinafter the combined invention) teaches the electrode assemblies as stated above in claim 1, and further teaches similar alternative embodiments of the electrode assembly (Skiba figures 1-2, 5-8) and delivering alternating voltage (paragraph 0051 – “For example, an AC power source can be of any wave form, such as a sine wave, a triangular wave, or a square wave. AC power can also be of any frequency such as for example 50 Hz or 60 HZ, or the like. AC power can also be of any voltage, such as for example 120 volts, or 220 volts, or the like”), in addition to generating electric fields (Skiba paragraph 0028 – “In embodiments devices disclosed herein can apply an electric field, an electric current, or both wherein the field, current, or both can be of varying size, strength, density, shape, or duration in different areas of a wound or tissue”).
The combined invention does not explicitly teach the method comprising positioning at least first and second electrode assemblies on a body of a subject; AND applying an alternating voltage between the first electrode assembly and the second electrode assembly, thereby generating tumor-treating electric fields.
Palti discloses a similar electrode apparatus for adhering to skin to deliver stimulation, particularly electric fields (Palti abstract – “The apparatus includes insulated electrodes to be coupled to a generator for subjecting the living tissue to electric field conditions…Preferably, an intervening member is disposed between each insulated electrode and the skin surface…”). Palti further teaches in figure 11, the known technique of providing two electrode assemblies 230 which are placed on a subject’s body and are used to generate alternating voltages (Palti paragraph 0077 – “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz…”) and thereby creates an electric field between the electrode assemblies (shown in Palti figure 11).
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The combined invention and Palti all teach within the field of electrode apparatuses which contact a subject’s skin to deliver stimulation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode assemblies and method of the combined invention to incorporate the known technique of positioning first and second electrode assemblies on a body of a subject, and delivering alternating voltage to create an electric field between the electrode assemblies as taught by Palti since such modification would predictably result in delivering tumor treating fields to treat desired target tumors, such as in Palti figure 11 (Palti paragraph 0089 – “The arrangement of the isolects 230 in FIG. 11 is particularly useful for treating a tumor 415 associated with lung cancer or gastro-intestinal tumors”).
Re. claim 21, the combined invention further teaches wherein the alternating voltage has a frequency between 50 kHz and 1 MHz (Palti paragraph 0077 – “The generator 210 generates an alternating voltage waveform at frequencies in the range from about 50 KHz to about 500 KHz (preferably from about 100 KHz to about 300 KHz) (i.e., the TC fields)”).
Re. claim 22, the combined invention further teaches a temperature sensor that is configured to output a signal indicative of a temperature of the apparatus (Van Der Beek paragraph 0053 – “It is also contemplated that one or more sensors may be provided on the electrodes 14. For example, a temperature sensor, motion sensors, microphone, oximetry sensor, or any combination thereof can be provided for detecting various physiological parameters of the user”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek) and Palti (US 20040068297 A1 – hereinafter Palti), and in further view of Juola (US 20110160559 A1 – hereinafter Juola).
Re. claim 3, the combined invention of Skiba, Van Der Beek and Palti (hereinafter the combined invention) teaches the plurality of electrodes as stated above, but does not explicitly teach wherein each electrode element of the plurality of electrode elements comprises: a layer of dielectric material having a skin-facing inner face and an opposing outer face; and a metallic layer having an inner face and an opposing outer face, wherein the metallic layer is disposed on the outer face of the layer of dielectric material.
Juola teaches a medical electrode for medical electrical sensing and stimulation (Juola paragraph 0001 – “The present teachings relate generally to medical electrical sensing and stimulation devices”), and teaches the electrode 10 in figure 1 which contains the known elements of the electrode comprising a lower dielectric layer 14 having a skin-facing inner face and an opposing outer face, and a conductive metal layer 16 having an inner face and an opposing outer face, wherein the metallic layer 16 is disposed on an outer face of the lower layer of dielectric material 14 (Juola figures 1 and 2; paragraph 0040 – “With reference to FIG. 1, a side profile view of a medical electrode in an embodiment according to the present teachings is shown. Electrode 10 can include an upper dielectric layer 12 and a lower dielectric layer 14 and a conductive metal 16 sandwiched between layers 12 and 14”).
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The combined invention and Juola all teach within the field of stimulation electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of the combined invention to incorporate the lower dielectric layer and the conductive metal layer arranged as taught by Juola since such modification would predictably result in, for example, “…sensing and reproducing electric potentials at the surface of living tissue and introducing electrical potentials into the tissue” (Juola paragraph 0002).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek), Palti (US 20040068297 A1 – hereinafter Palti) and Juola (US 20110160559 A1 – hereinafter Juola), and in further view of Sheraton (US 20100331659 A1 – hereinafter Sheraton).
Re. claim 4, the combined invention of Skiba, Van Der Beek, Palti and Juola (hereinafter the combined invention) teaches the claimed invention of claim 3 as stated above, but does not explicitly teach wherein the dielectric material is a ceramic material.
Sheraton teaches an electrode arrangement comprising layers for stimulation (Sheraton abstract – “An electrode arrangement for low artifact electrocardiogram (ECG) monitoring and defibrillation…”). Sheraton further teaches in figure 4, an electrode 400 comprising a metal silver-silver/chloride conductor print line 402 (Sheraton paragraph 0031 – “The electrode arrangement 400 comprises of at least one Ag/AgCl conductor print line body 402 having a large Ag/AgCl print line area functioning as a defibrillation area 404 and a small Ag/AgCl print line area functioning as a central sensing area 406”), which is disposed above the insulator sheet 414, which can be made of a ceramic (Sheraton paragraph 0031 – “The at least one insulator sheet 414 can be a plastic film, printable resin, or ceramic”).
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The combined invention and Sheraton all teach within the field of stimulation electrodes with dielectric materials. The combined invention teaches the dielectric layer as stated above in claim 3, while Sheraton teaches the known dielectric material layer made of ceramic as stated above. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dielectric material layer of the combined invention to substitute with the known dielectric of a ceramic sheet layer as taught by Sheraton since such modification would predictably result in, for example, directing electrical current to specific areas and preventing unintended stimulation or damage to surrounding tissues.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek) and Palti (US 20040068297 A1 – hereinafter Palti), and in further view of Fahey (US 20100004715 A1 – hereinafter Fahey) (cited previously).
Re. claim 8, the combined invention of Skiba, Van Der Beek and Palti (hereinafter the combined invention), specifically Skiba of the combined invention further teaches figure 1 showing eight columns and six rows of electrodes 6, 10 and their repetitions 12, all spaced between spacing 8 as stated above in claim 1. The combined invention does not explicitly teach each row of electrode elements comprises three electrode elements.
Fahey teaches a transcutaneous stimulation electrode array pad device for neuromuscular stimulation (Fahey abstract – “The invention provides systems and methods for neuromuscular electrical stimulation to muscle tissue”). Fahey further teaches in figures 14-15 that it is known for electrode pads to carry electrode arrays with three rows, each row comprising three electrode contacts (Fahey figures 14-15 below; paragraph 0111 – “Similarly, a different number of individual stimulation electrode contacts in the array could be employed to empower the use of the disclosed method, such as one, two, three, four, six, nine, ten, twelve, fifteen, twenty, or more stimulation electrode contacts”; paragraph 0195 – “The stimulation pad 1402 may comprise one or more electrode 1406”).
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The combined invention and Fahey all teach within the field of stimulation electrodes. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electrode arrangement of the combined invention to incorporate the rows of three electrodes as taught by Fahey since such modification would still predictably result in delivering stimulation treatment to a target tissue.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek) and Palti (US 20040068297 A1 – hereinafter Palti), and in further view of Imran (US 20100331811 A1 – hereinafter Imran) (cited previously).
Re. Claim 9, are further rejected as evidenced by MTI Corporation ("Important Info About Pyrolytic Graphite Substrate" [online]. MTI Corporation, 2024 [retrieved on 2025-08-19]. Retrieved from the Internet: <URL: https://mtixtl.com/blogs/ceramic-glass-substrate-a-z-info-base/important-info-about-pyrolytic-graphite-substrate >), and Panasonic ("Pyrolytic Graphite Sheet Evolves: New twists on this thermally conductive material expand applications" [online]. Panasonic [retrieved on 2025-08-19]. Retrieved from the Internet: <URL: https://na.industrial.panasonic.com/file-download/8557 >).
Re. claim 9, the combined invention of Skiba, Van Der Beek and Palti (hereinafter the combined invention) teaches the anisotropic layer as stated above in claim 1, but does not explicitly teach wherein the layer of anisotropic material has 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 wherein the layer of anisotropic material has 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.
Imran teaches a transdermal electrode arrangement (Imran abstract – “Embodiments of the invention provide electrode assemblies and associated methods for the iontophoretic transdermal delivery of therapeutic agents”). Imran further teaches that the electrode assembly 10 has an electrode layer 40 that is made of pyrolytic graphite, which is a synthetic/manufactured form of graphite and is “extremely anisotropic” (Imran paragraph 0034 – “Embodiments include use of other graphites such as pyrolytic graphite. 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. Specific embodiments of pyrolytic graphite electrode 40…”; shown in figure 2, as well as figures 4-5b).
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Furthermore, pyrolytic graphite is known to have a high thermal conductivity in the A-B plane, or the X-Y plane, as opposed to its low thermal conductivity at the perpendicular C plane, or the Z plane, which would make the A-B/X-Y plane thermal conductivity be upwards of 100 times or more larger than the C/Z plane (see page 1 of the MTI Corporation web page below, showing typical thermal conductivities of pyrolytic graphite in the AB plane and C plane).
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(see page 2 of the Panasonic pyrolytic graphite sheets [PGS] Non-Patent Literature below, showing the thermal conductivities of the PGS in the X-Y plane and Z plane).
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Therefore, since the combined invention and Imran all teach within the field of electrodes comprising anisotropic layers, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anisotropic layer of the combined invention to incorporate the anisotropic pyrolytic graphite layer as taught by Imran since such modification would predictably result in, for example, “…to allow for the electrical conduction through the electrode, but [also] provide for thermal insulation in one or more directions” (Imran paragraph 0034).
Re. claim 12, the combined invention of Skiba, Van Der Beek and Palti (hereinafter the combined invention) teaches the claimed invention as stated above, but does not explicitly teach wherein the layer of anisotropic material is or comprises a layer of pyrolytic graphite, graphitized polymer film, or graphite foil made from compressed high purity exfoliated mineral graphite.
Imran teaches a transdermal electrode arrangement (Imran abstract – “Embodiments of the invention provide electrode assemblies and associated methods for the iontophoretic transdermal delivery of therapeutic agents”). Imran further teaches that the electrode assembly 10 has an electrode layer 40 is made of pyrolytic graphite, which is a synthetic/manufactured form of graphite an is extremely anisotropic (Imran paragraph 0034 – “Embodiments include use of other graphites such as pyrolytic graphite. 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. Specific embodiments of pyrolytic graphite electrode 40…”; shown in figure 2, as well as figures 4-5b).
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Since the combined invention and Imran all teach within the field of electrodes comprising anisotropic layers, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anisotropic layer of the combined invention to incorporate the anisotropic pyrolytic graphite layer as taught by Imran since such modification would predictably result in, for example, “…to allow for the electrical conduction through the electrode, but provide for thermal insulation in one or more directions” (Imran paragraph 0034).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek) and Palti (US 20040068297 A1 – hereinafter Palti), and in further view of Ferrari (US 5733324 A – hereinafter Ferrari) (cited previously).
Re. claim 13, the combined invention of Skiba, Van Der Beek and Palti (hereinafter the combined invention) teaches the skin contact structure comprising conductive adhesive composite as stated above in claim 1, but does not explicitly teach the skin contact structure comprising: an outer adhesive layer comprising a conductive adhesive composite; a skin facing inner adhesive layer comprising a conductive adhesive composite; and a substrate positioned between the inner and outer adhesive layers.
Ferrari teaches a transcutaneous stimulation electrode (Ferrari column 1, lines 12-15: “The present application relates to a transcutaneous stimulating or defibrillating electrode, and more particularly to a multi-function defibrillating electrode that is also X-ray transmissive”). Ferrari further teaches in figure 9, the transcutaneous electrode 10 comprising a layer of a metal foil 135c substrate, and further teaches that the metal foil can be coated with a conductive polymer adhesive on the upper side (outer layer) AND lower side (inner layer) of the foil substrate (Ferrari column 2, lines 28-31: "In a further embodiment, the current distributing mat includes a conductive metal foil coated with a conductive polymer adhesive on the upper and lower sides of the foil").
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The combined invention and Ferrari teach within the field of layered stimulation electrodes with conductive adhesive composites. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the skin contact structure with the conductive adhesive composites, as taught by combined invention, to incorporate the metal foil substrate layer with the conductive polymer adhesive composite on the upper and lower sides of the metal foil substrate layer as taught by Ferrari since such modification would predictably provide the electrode apparatus with structural integrity to hold the layers together when adhered to a target tissue.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek), Palti (US 20040068297 A1 – hereinafter Palti) and Ferrari (US 5733324 A – hereinafter Ferrari), and in further view of Burton (US 4067342 A – hereinafter Burton) (cited previously).
Re. claim 14, the combined invention of Skiba, Van Der Beek, Palti and Ferrari (hereinafter the combined invention) teaches the claimed invention of claim 13 as stated above, including the conductive adhesive composite as stated above in claim 1, but does not explicitly teach wherein the conductive adhesive composite of the inner and outer adhesive layers of the skin contact structure, each, individually, comprises: a dielectric material; and conductive particles dispersed within the dielectric material.
Burton discloses a tape electrode configured to deliver stimulation signals to a subject (Burton abstract – “A tape electrode usable for the transmission of electrical signals into the human body through the skin”). Burton further teaches the tape electrode in figures 1-2 comprising the tape substrate 10, and a layer 12 which comprises a combination of an adhesive material “such as acrylic polymer adhesive”, which is a known dielectric, and a quantity of silver metal blended within the dielectric acrylic polymer adhesive to make the adhesive layer conductive (Burton column 3, lines 1-6: “The tape substrate 10 has positioned on one side thereof, a layer 12 of an electrically conductive material. The latter is a combination of the adhesive material, such as an acrylic polymer adhesive, into which has been blended a quantity of silver metal to make the adhesive layer conductive”), which would disperse conductive particles within the dielectric acrylic polymer adhesive to create a conductive adhesive composite.
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The combined invention and Burton all teach within the field of stimulation electrodes with conductive adhesive composites. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the conductive adhesive composite of the skin contact layer, as taught by the combined invention, to substitute with the dielectric acrylic polymer adhesive blended with conductive silver metal, as taught by Burton, since such modification would predictably result in “making the adhesive layer conductive” (Burton column 3, lines 1-6) and allow application of electrical stimulation signals through the electrode (Burton abstract).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skiba (US 20160059009 A1 – hereinafter Skiba) in view of Van Der Beek (US 20130066412 A1 – hereinafter Van Der Beek) and Palti (US 20040068297 A1 – hereinafter Palti), and in further view of Fincke (US 5330526 A- hereinafter Fincke) (cited previously).
Re. claim 15, the combined invention of Skiba, Van Der Beek and Palti (hereinafter the combined invention) teaches the claimed invention as stated above, including the filler structure as stated above in claim 1, but does not explicitly teach wherein the at least one filler structure is or comprises a foam, a gel, or a hydrocolloid.
Fincke similarly teaches a transcutaneous stimulation electrode (Fincke abstract – “An electrode for transcutaneously delivering defibrillation pulses to a patient's heart”). Fincke further teaches in figure 2A-2B, the electrodes 12 and 14, comprising the electrode conducting plates 32, 34 which are encapsulated by gel foam layer 36, 38 which fill spaces beyond the frame including the spaces between the conducting plates 32, 34, or excursions 33 as a gel foam filler structure (Fincke column 6, lines 32-38: “The gel foam layers 36, 38, like the conducting plates 32, 34 under them, may comprise a geometry which maximizes the gel perimeter for a given general shape. For example, the front electrode gel foam layer 36 may include excursions 33 to thereby increase the layer perimeter beyond that which a simple circle would provide”).
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The combined invention and Fincke all teach within the field of stimulation electrodes with filler structures. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filler structure of the combined invention to substitute with the gel foam layers as taught by Fincke since such modification would predictably result in, for example, decreasing the potential for burning associated with the electrode during stimulation (Fincke column 6, lines 40-44).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796