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
The amendment filed 01/05/2026 has been entered. Claims 1, 4, 7, 9-15, and 21-30 remain pending in the application.
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, 4 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hinman et al. (US 20230211161 A1), hereinafter Hinman, in view of Burnham et al. (US 20180042108 A1), hereinafter Burnham, in view of Gusakov et al. (US 5848966 A), hereinafter Gusakov.
Regarding claim 1, Hinman discloses an apparatus (abstract:
“treatment applicators”) comprising: at least one electrode element ([0009]: " first electrode") having a skin-facing surface (Fig 5, wherein the electrode is placed on the skin, [0044]); a skin contact layer comprising an adhesive composite ([0061]: "a tissue-contacting surface that may include a hydrogel and/or adhesive material"), and wherein the apparatus is configured to deliver tumor-treating fields to a subject ([0033]: “for treatment of various skin conditions, lesions, tumors, growth or abnormalities.”).
Hinman discloses further discloses the at least one electrode element is electrically coupled to the skin contact layer ([0012]: “The first electrode may comprise a first electrically conductive hydrogel or other conductive polymer matrix extending to an outer, tissue-contacting surface”), but fails to disclose the skin contact layer comprises a conductive adhesive composite having a thickness, wherein the conductive adhesive composite comprises: a dielectric material: and conductive particles dispersed within the dielectric material, wherein at least a portion of the conductive particles define a conductive pathway through the thickness of the conductive adhesive composite.
Burnham discloses an apparatus (abstract) comprising: a skin contact layer ([0076]: “pressed to the skin of the test subject.”) comprising a conductive adhesive composite ([0012]: “an electrically conductive composite”) having a thickness (Fig 4 thickness z), wherein the conductive adhesive composite comprises: a dielectric material ([0013]: “a dielectric material having a first side and a second side”): and conductive particles dispersed within the dielectric material, wherein at least a portion of the conductive particles define a conductive pathway through the thickness of the conductive adhesive composite ([0013]: “The conductive particles are aligned to form a plurality of conductive paths from the first side to the second side of the dielectric material, and each of the conductive paths is formed of at least a plurality of conductive particles.”)
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the skin contact layer disclosed by Hinman to the conductive adhesive composite disclosed by Burnham in order to ensure adhesion of the device without compromising the properties of the electrodes (Burnham [0003-0004]).
Hinman as modified by Burnham fails to disclose an adhesive tape or bandage.
Gusakov discloses an electrode assembly (abstract) including an adhesive tape or bandage (col 1 lines 21-22: “an adhesive tape or pad for holding the terminal member in place on the skin”, disclosed in the background as well known in the art).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known adhesive gel disclosed by Hinman with the known adhesive tape disclosed by Gusakov for the predictable result of ensuring the apparatus remains attached to the skin during operation (Gusakov col 1 lines 21-22).
Regarding claim 4, Hinman as modified by Gusakov and Burnham discloses the apparatus of claim 1. Burnham fails to disclose the dielectric material is an acrylic adhesive or a silicone adhesive, or a combination thereof. Hinman further discloses wherein the dielectric material is an acrylic adhesive or a silicone adhesive, or a combination thereof ([0070]: "an electrically insulating silicone adhesive").
As Burnham discloses the dielectric material may include a variety of adhesives ([0038]: “e.g., a pressure sensitive adhesive, a heat activatable adhesive or a radiation curable adhesive”) but fails to specify an adhesive, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known dielectric material disclosed by Burnham with the known dielectric material disclosed by Hinman for the predictable result of insulating an electrode.
Regarding claim 21, Burnham further discloses wherein the conductive particles comprise carbon particles ([0038]: “conductive materials 10 (e.g., 5% by weight carbon particles) within a dielectric material”).
Regarding claim 22, Burnham further discloses wherein the carbon particles comprise one or more of graphite powder, carbon flakes, carbon granules, carbon fibers, carbon nanotubes, carbon nanowires, or carbon black powder ([0074]: “and 15% by dry weight of a conductive carbon, Aquablak 5909 (from Solution Dispersions, Cynthiana, Ky. 41031.”).
Regarding claim 23, Burnham fails to disclose the dielectric material is an acrylic adhesive or a silicone adhesive, or a combination thereof. Hinman further discloses wherein the dielectric material is an acrylic adhesive or a silicone adhesive, or a combination thereof ([0070]: "an electrically insulating silicone adhesive").
As Burnham discloses the dielectric material may include a variety of adhesives ([0038]: “e.g., a pressure sensitive adhesive, a heat activatable adhesive or a radiation curable adhesive”) but fails to specify an adhesive, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known dielectric material disclosed by Burnham with the known dielectric material disclosed by Hinman for the predictable result of insulating an electrode.
Claim(s) 7, 10 and 24-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faupel (US 20100049078 A1) in view of Santala (US 20190350525 A1) in further view of Palti (US 20040068296 A1).
Regarding claim 7, Faupel discloses a method comprising positioning a plurality of electrode assemblies on a target site of a subject ([0023]: “and a multiple sensor array 16 is applied to the area of suspicion and a reference sensor is applied to the mirror image positions on the opposite (left) forearm (not shown)… large array of electrodes 16”); and comparing respective conditions of skin of the subject at each respective location from which each electrode assembly of the plurality of electrode assemblies was removed ([0043]: “then the pattern recognition program might weight more heavily differences in point to point ELFAC potentials between the two mirror-image organ systems or locations 78, such as between two extremities or between two breasts.”).
Faupel fails to disclose one or more each electrode assembly of the plurality of electrode assemblies comprising: at least one electrode element having a skin-facing surface, a skin contact layer a conductive adhesive composite, and an adhesive tape or bandage, wherein the at least one electrode element is electrically coupled to the skin contact layer, and removing the plurality of electrode assemblies from the target site of the subject after a predetermined period of time.
Santala discloses positioning a plurality of electrode assemblies on a target site of a subject (Fig 1A and 1B, elements 10 and 14), the one or more each electrode assembly of the plurality of electrode assemblies comprising: at least one electrode element having a skin-facing surface ([0023]: “surface electrode 10”); a skin contact layer comprising a conductive adhesive component (Fig 2B, element 22 comprising element 26, [0020]: “An electrode gel channel 26 is configured to conduct potentials from the patient's skin 5”), and an adhesive tape or bandage ([0025]: “The silicone adhesive layer 22”, consistent with applicant’s specification para [0042]: “adhesive tape or bandage may comprise a silicone adhesive”), wherein the at least one electrode element is electrically coupled to the skin contact layer ([0023]: “The electrode gel channel 26 runs through the cavity formed by the holes in the respective layers so as to enable contact between the patient's skin 5 and the active electrode layer 14.”).
It would have been obvious to a person of ordinary skill in the art to modify the electrode assembly disclosed by Faupel to the electrode element having a skin-facing surface, a skin contact layer comprising a conductive adhesive component, and an adhesive tape or bandage disclosed by Santala in order to allow for removal of the electrodes without damaging the patient’s skin (Santala [0014]).
Faupel as modified by Santala fails to disclose removing the plurality of electrode assemblies from the target site of the subject after a predetermined period of time.
Palti discloses removing a plurality of electrode assemblies ([0095]: “a number of insulated electrodes 230 along with the mechanism 530 are preferably formed as an independent unit, generally indicated at 540”) from the target site of the subject after a predetermined period of time ([0099]: “after a predetermined time period or after a number of uses, the patient removes the units 540”).
As Faupel as modified by Santala discloses removal of electrode assemblies (Santala [0004]: “adhere the surface electrode to the patient's skin and to be removed from the patient's skin”), it would have been obvious to a person of ordinary skill in the art to modify the method disclosed by Faupel as modified by Santala to include the removal of a plurality of electrode assemblies from the target site of the subject after a predetermined period of time as disclosed by Palti in order to allow for reapplication of a coupling agent (Palti [0099]).
Regarding claim 24, Faupel further discloses wherein comparing the respective conditions of skin of the subject at each respective location comprises detecting at least one adverse event ([0022]: “obtaining and analyzing noise-minimized ELFAC data and integrating those data with other information to produce a disease diagnosis.”).
Regarding claim 25, Faupel further discloses wherein the at least one adverse event comprises one or more of dermatitis, pruritus, erosions, ulcers, folliculitis, or xerosis ([0039]: “and the output of a pattern recognition program for the diagnosis of a skin lesion”)
Regarding claim 26, Santala further discloses replacing each of the plurality of electrode assemblies at each respective location ([0017]: “can move the electrode to a new area”).
Regarding claim 27, Santala further discloses wherein a first electrode assembly of the plurality of electrode assemblies differs from a second electrode assembly of the plurality of electrode assemblies (Fig 1A).
Regarding claim 28, Santala further discloses further comprising repeatedly replacing each of the plurality of electrode assemblies at each respective location and removing the plurality of electrode assemblies for a plurality of iterations ([0017-0018]: “meaning that the electrode can be reattached to a patient if it has come off or been removed (partially or completely)… the electrodes can be repositioned, clinicians can move the electrodes during the monitoring process in order to optimize the recording of the physiological signals.”).
Regarding claim 29, Faupel discloses wherein the predetermined period of time is from one day to seven days ([0043]: “The pattern recognition program initiates at 70. Subject clinical information, inputted via standard devices at 56 such as a keypad or from a menu on a touch sensitive screen or any suitable input device, constitute the initial steps in the sequence. For example, at 72 the program diverges depending on whether the subject is pre- or post menopausal, if the subject is premenopausal, then the numerical value corresponding to day in menstrual cycle is entered at 74. The program diverges again at 76 if the subject is in a hormonally active segment of the menstrual cycle…. then the pattern recognition program might weight more heavily differences in point to point ELFAC potentials between the two mirror-image organ systems or locations 78, such as between two extremities or between two breasts.”).
Regarding claim 30, Santala discloses wherein the conductive adhesive composite of a first electrode assembly of the plurality of electrode assemblies differs from the conductive adhesive composite of a second electrode assembly of the plurality of electrode assemblies ([0019-0028]: “the adhesive layer 19 may be a different type of adhesive other than acrylic…the substrate 20 may be configured differently to provide a different configuration of electrode nodes 20 a and/or bridging strips 20 b. F”).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faupel in view of Santala in view of Palti in view of Gusakov.
Regarding claim 9, Faupel as modified by Santala and Palti discloses the method of claim 7, but fails to disclose wherein the removing comprises applying one or more of mineral oil, hexamethyldisiloxane, or a wipe comprising isopropyl alcohol, hydrotreated heavy naphtha, or (2-methoxymethylethoxy)propanol or combination thereof.
Gusakov discloses an electrode assembly (abstract) wherein the removing the assembly comprises applying one or more of mineral oil, hexamethyldisiloxane, and a wipe comprising isopropyl alcohol, hydrotreated heavy naphtha, or (2-methoxymethylethoxy)propanol or combination thereof (col 2 lines 28-30: “The removal of medical electrodes or transdermal patches from the skin of patients risks discomfort or pain. A clinician can apply a specific solvent, such as isopropyl alcohol, to help remove the electrode”, wherein the application of isopropyl alcohol is disclosed in the background as known in the art).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the removal process disclosed by Hinman with the application of isopropyl alcohol as disclosed by Gusakov in order to prevent pain to the subject on removal of the electrode (Gusakov col 2 lines 28-30).
Regarding claim 10, Faupel further discloses applying an alternating voltage between at least two electrode assemblies, thereby generating an alternating electric field ([0009]: “The important diagnostic inputs to pattern recognition are referred to here as extremely low frequency alternating currents (ELFACs). Such method and apparatus operate to measure and analyze electromagnetic activity from regions of diseased tissue on or internal to a living organism.”, wherein applying the alternating voltage occurs prior to removing at least one of the electrode assemblies ([0009], wherein application would have to occur while the electrode are connected).
Claim(s) 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faupel in view of Santala in view of Palti in view of Davies (US 20120271141 A1).
Regarding claim 11, Faupel in view of Santala discloses the method of claim 7 but fails to disclose applying a skin protectant agent to the target site either: prior to positioning at least one or more electrode assemblies on a target site, or after removing at least one of the one or more electrode assemblies.
Davies discloses an electrode assembly (title) wherein a skin protectant agent is applied prior to positioning at least one or more electrode assemblies on a target site ([0038]: “cleaning the skin with alcohol”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Hinman as modified by Gusakov to include the step of applying a skin protectant agent as disclosed by Davies in order to enhance the conductance of the underlying skin prior to application of an electrode (Davies [0038]).
Regarding claim 12, Faupel in view of Santala and Davies discloses the method of claim 11, and Davies further discloses the skin protectant agent comprises one or more of a steroid, an alcohol, and a siloxane copolymer ([0038]).
Regarding claim 15, Faupel in view of Santala and Davies discloses the method of claim 11, and Hinman further discloses the adhesive composite comprises a hydrogel ([0061]: " a tissue-contacting surface that may include a hydrogel and/or adhesive material") and an acrylic polymer, or a silicone polymer, or a combination thereof ([0067]: "In this example, parallel strips of conductive hydrogel (similar to RF ground pads or AED defibrillator pads), may be separated by a gap by an insulated adhesive (such as silicone)").
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faupel in view of Santala in view of Palti in view of Davies in further view of Brunet et al. (US 20220202624 A1), hereinafter Brunet.
Faupel in view of Santala, Palti, and Davies discloses the method of claim 12, but fails to disclose wherein the steroid comprises betamethasone.
Brunet discloses a method of applying an adhesive to the skin ([0001]) wherein a skin protectant steroid is applied ([0088]) comprising betamethasone ([0113]: “steroidal anti-inflammatory drugs: betamethasone”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the skin protectant disclosed by Hinman as modified by Davies and Gusakov to betamethasone as disclosed by Brunet in order to leverage the anti-inflammatory properties of betamethasone to mitigate subject discomfort caused by electrode application (Brunet [0085], [0109]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faupel in view of Santala in view of Palti in view of Davies in further view of Radhakrishnan et al. (“Spray bandage strategy in topical drug delivery”), hereinafter Radhakrishnan.
Faupel in view of Santala, Palti, and Davies discloses the method of claim 12, but fails to disclose wherein the siloxane copolymer comprises a hexamethylsiloxane/acrylate copolymer.
Radhakrishnan discloses a skin protectant comprising a siloxane copolymer that comprises a hexamethylsiloxane/acrylate copolymer (Table 1 Row 1).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the skin protectant disclosed by Hinman as modified by Davies and Gusakov to a hexamethylsiloxane/acrylate copolymer as disclosed by Radhakrishnan in order to leverage the anti-microbial properties of the hexamethylsiloxane/acrylate copolymer as a skin protectant (Radhakrishnan table 1 column 5).
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks pages 10-11, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1 and dependent claims under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. § 103 (see above).
Applicant’s arguments with respect to claim(s) with respect to the rejection(s) of claim(s) 7 and dependent claims under 35 U.S.C. § 103 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.
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.
/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791