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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/25/2026 has been entered.
Response to Amendment
The amendment filed 06/25/2026 has been entered. Amendments to claims 7, 11 and 24, cancellation of claims 1, 4, 21-23, 27, and 30, and new claims 31-35 are acknowledged. Claims 7, 9-15, 24-26, 28-29, and 31-35 remain pending in the application.
Election/Restriction
Newly submitted claims 31-35 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 7, 9-15, 24-26, and 28-29, drawn to a method of positioning an electrode assembly with a first and second contact layer, classified in A61F13/0253.
Claim 31, drawn to a method of positioning an electrode assembly, classified in A61B5/6833.
Claims 32-35, drawn to a method of placing an electrode assembly and generating an electric field, classified in A61B5/411.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the electrode assembly does not require a first and second adhesive in order to attach to a subject. The subcombination has separate utility such as causing multiple reactions based on different adhesive composites.
Inventions III and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the electrode assembly does not require a first and second adhesive in order to attach to a subject. The subcombination has separate utility such as causing multiple reactions based on different adhesive composites.
Inventions II and III are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the electrode assembly does not require affecting an electrode in order to compare the skin of the subject where an electrode was removed. The subcombination has separate utility such as affecting an electrode in a method different from a separate electrode assembly to generate differing reactions.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 31-35 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7, 9-15, and 24-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 discloses the limitation “a second adhesive tape or bandage that is different from the first adhesive tape or bandage”. While applicant’s disclosure supports different materials used for the adhesive composite (specification para [0047]: “In some embodiments the conductive adhesive composite of one electrode assembly can be different from the conductive adhesive composite of another electrode assembly”), it does not support different adhesive tape or bandage materials used for the first and second assembly. If the claim is meant to be interpreted to refer to a tape or bandage that is different in that it is not the same physical bandage as the first (as in located on the second assembly and not the first), the support for that can be found in the drawings wherein the assemblies are physically separated from one another. For the purposes of examination, the latter interpretation will be used.
Claims 9-15 and 24-26, and 28-29 are rejected due to dependency.
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) 7, 9-13, and 24-26, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over of Siesbye et al. (US 20230241382 A1) in view of Lacouture et al. (“Prevention and Management of Dermatologic Adverse Events Associated With Tumor Treating Fields in Patients With Glioblastoma”).
Regarding claim 7, Siesbye discloses positioning a plurality of electrode assemblies on skin of a subject so that each electrode assembly of the plurality of electrode assemblies is placed at a respective location on the subject (Fig 2 top and bottom assemblies), each electrode assembly of the plurality of electrode assemblies comprising: at least one electrode element having a skin-facing surface ([0087]: “electrodes 204 and 205”); a skin contact layer comprising a conductive adhesive composite ([0089]: “and the conductive gel layer 210 is contacting the surface of the skin 211 surrounding the wound (not shown).”), wherein the at least one electrode element is electrically coupled to the skin contact layer ([0064]: “The electrical contact between the electrodes and the skin surrounding a wound may be any kind of contact made between an electrode and the skin”); wherein the plurality of electrode assemblies comprises at least a first electrode assembly and a second electrode assembly (Fig 2 wherein there are 2 assemblies); wherein the first electrode assembly comprises a first skin contact layer comprising a first conductive adhesive composite (Fig 2 elements 204a 206a and 205a, Fig 3 element 210); a second skin contact layer comprising a second conductive adhesive composite that is different from the first conductive adhesive composite (Fig 2 elements 204a 206a and 205a, Fig 3 element 210, wherein the second contact layer is separated from the first layer as it covers the second assembly, and therefore “different”); and comparing respective conditions of the skin of the subject at each respective location from which each electrode assembly of the plurality of electrode assemblies was removed ([0094]: “Two electrodes were arranged on dry skin on a person's arm, the distance between the electrodes being 50 mm…. After several hours of AC measurements, there is no irritation to the skin, while the DC (non-pulsed) measurements, which took only 10 minutes, and which measured currents below 0.5 mA, nevertheless resulted in red and irritated skin under the positive electrode”).
Siesbye fails to disclose an adhesive tape or bandage. While Siesbye discloses removing the plurality of electrodes assemblies ([0017]: “enable easy installation of the stimuli electrodes and may afford less pain for the patient when arranged and removed”), they fail to specifically disclose removing the plurality of electrodes assemblies from the skin of the subject after a predetermined period of time.
Lacouture discloses an adhesive tape or bandage (Fig 1 bottom panel 1, caption : “A hypoallergenic cover tape holds tan arrays in place on the scalp”) and removing the plurality of electrodes assemblies from the skin of the subject after a predetermined period of time (Tumor Treating Fields para 2: “The arrays are worn continuously for 3–4 days before removal”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the electrode assemblies disclosed by Siesbye to include the adhesive tape disclosed by Lacouture in order to improve adhesion of the assembly and it would have been obvious to include removal of the electrodes after a predetermined amount of time as disclosed by Lacouture in order to allow hygienic care of the skin (Lacouture Tumor Treating Fields para 2).
Regarding claim 9, Lacouture further discloses 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 (Table 2 col 2 row 3: “Apply mineral (baby) oil to the scalp to gently remove arrays; slowly and gently peel back the arrays from the skin”).
Regarding claim 10, Siesbye discloses applying an alternating voltage between at least two electrode assemblies, thereby generating an alternating electric field, wherein applying the alternating voltage occurs prior to removing at least one of the electrode assemblies ([0018]: “which alternates between periods of no voltage to a period with voltage, such as alternating between 0V and 5V, between 0V and 10V, between OV and 20V, and between 0V and 50V.”, [0095]: “using an AC signal having a frequency of at least 10 kHz”).
Regarding claim 11, Lacouture further discloses further comprising applying a skin protectant agent to the respective location on the subject of at least one electrode of the plurality of electrode assemblies either: prior to positioning at least one or more electrode assemblies on the subject, or after removing at least one of the one or more electrode assemblies (Patient Education to Prevent Dermatologic AEs: “For sensitive skin or hyperhidrosis, skin barrier products (Figure 3B) are recommended to impede moisture and protect against dermatitis, irritants, and minor injury”, Fig 3B).
Regarding claim 12, Lacouture further discloses wherein the skin protectant agent comprises one or more of a steroid, an alcohol, and a siloxane copolymer (Table 2 col 2 row 2: “wipe the scalp with a gauze or cotton ball soaked in first aid isopropyl alcohol (70%)”).
Regarding claim 13, Lacouture further discloses wherein the steroid comprises betamethasone (Table 1 case 3: “Topical corticosteroids may be prescribed if inflammation is present (e.g., betamethasone, clobetasol, fluocinonide).”).
Regarding claim 24, Siesbye further discloses wherein comparing the respective conditions of the skin of the subject at each respective location comprises detecting at least one adverse event ([0094]: “nevertheless resulted in red and irritated skin under the positive electrode,”).
Regarding claim 25, Siesbye further discloses wherein the at least one adverse event comprises one or more of dermatitis, pruritus, erosions, ulcers, folliculitis, or xerosis ([0094]: “nevertheless resulted in red and irritated skin under the positive electrode,”, wherein red and irritated skin is indicative of dermatitis).
Regarding claim 26, Siesbye fails to disclose further comprising replacing each of the plurality of electrode assemblies at each respective location.
Lacouture replacing each of the plurality of electrode assemblies at each respective location (Prophylactic Interventions para 1: “Arrays should be changed at least 2 times per week, approximately every 3 days, although some patients may benefit from more frequent replacement (e.g., with hyperhidrosis or quick hair growth).”).
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 Siesbye to include replacement of the electrode assemblies as disclosed by Lacouture in order to decrease the risk and severity of adverse events (Lacouture Prophylactic Interventions para 1).
Regarding claim 28, Siesbye fails to disclose 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.
Lacouture discloses 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 (Prophylactic Interventions para 1: “Arrays should be changed at least 2 times per week, approximately every 3 days, although some patients may benefit from more frequent replacement (e.g., with hyperhidrosis or quick hair growth).”).
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 Siesbye to include replacement of the electrode assemblies as disclosed by Lacouture in order to decrease the risk and severity of adverse events (Lacouture Prophylactic Interventions para 1).
Regarding claim 29, Lacouture discloses wherein the predetermined period of time is from one day to seven days plurality of electrode assemblies for a plurality of iterations (Prophylactic Interventions para 1: “Arrays should be changed at least 2 times per week, approximately every 3 days, although some patients may benefit from more frequent replacement (e.g., with hyperhidrosis or quick hair growth).”).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over in view Siesbye in view of Lacouture in further view of Lukenbach (US 20020035046 A1)
Regarding claim 14, Siesbye as modified by Lacouture discloses the method of claim 13 but fails to disclose wherein the siloxane copolymer comprises a hexamethylsiloxane/acrylate copolymer.
Silvers discloses a skin protectant ([0061]: “personal care composition”) comprising a hexamethylsiloxane/acrylate copolymer ([0061]: “Examples of suitable silicones nonexclusively include the polydimethyl siloxanes and derivatives thereof such as hexamethylsiloxane”).
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 Siesbye in view of Lacouture to include a hexamethylsiloxane/acrylate copolymer as disclosed by Lukenbach in order to improve the aesthetics of the protectant (Lukenbach [0061]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siesbye in view of Lacouture in view of Martins et al. (US 20170281926 A1).
Regarding claim 15, Siesbye in view of Lacouture discloses the method of claim 11 but fails to disclose wherein the conductive adhesive composite comprises a hydrogel and an acrylic polymer or a silicone polymer, or a combination of the acrylic polymer and the silicone polymer.
Martins discloses wherein the conductive adhesive composite comprises a hydrogel and an acrylic polymer (Table 1, [0049]: “The hydrogels used in the EXAMPLES were composed basically of polyacrylic acid, glycerin and potassium chloride and are supplied with two release liners.”) or a silicone polymer, or a combination of the acrylic polymer and the silicone polymer.
As Siesbye discloses a conductive adhesive composite but fails to specify a type, 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 Siesbye as modified by Lacouture to include the conductive adhesive composite comprised of a hydrogel and an acrylic polymer as disclosed by Martin in order to clarify the type of composite used.
Claim(s) 7, 24-26, and 28-29 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 view of Palti (US 20040068296 A1) in further view of Pierart (US 20210298679 A1).
Regarding claim 7, Faupel discloses a method comprising positioning a plurality of electrode assemblies on a skin 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”); wherein the plurality of electrode assemblies comprises at least a first electrode assembly and a second electrode assembly ([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]).
Faupel as modified by Santala and Palti discloses wherein the plurality of electrode assemblies comprises at least a first electrode assembly and a second electrode assembly ([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 wherein the first electrode assembly comprises a first skin contact layer comprising a first conductive adhesive composite and a first adhesive tape or bandage (As modified by Santala [0020]: “An electrode gel channel 26 is configured to conduct potentials from the patient's skin 5”), but fails to disclose wherein the second electrode assembly comprises at least one of: a second skin contact layer comprising a second conductive adhesive composite that is different from the first conductive adhesive composite; or a second adhesive tape or bandage that is different from the first adhesive tape or bandage.
Pierart discloses a second skin contact layer comprising a second conductive adhesive composite that is different from the first conductive adhesive composite ([0036]: “a plurality of patches as defined above, in which all the patches are identical or at least two patches have: [0037] a different length, and/or [0038] a different width, and/or [0039] a different orifice shape, [0040] where appropriate, a different adhesive”)
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the adhesive disclosed by Faupel as modified by Santala and Patli to include the second conductive adhesive as disclosed by Pierart in order to allow for adaption to differing circumstances of placement such as skin type or conditions (Pierart [0112]).
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 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.”).
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/25/2025, with respect to the rejection(s) of claim(s) 7 under 35 U.S.C. § 103 have been fully considered and are persuasive. Specifically, Faupel as modified by Santala and Patli fail to disclose a second skin contact layer comprising a second conductive adhesive that is different from the first conductive adhesive. 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). Furthermore, Applicant's arguments with respect to modification of Faupel have been considered but they are not persuasive. Applicant argues on pages 9 and 10 of applicant’s remarks that modification of Faupel to include a second adhesive composite different from the first adhesive composite would render Faupel unfit for its intent purpose as it would have changed the principle of operation of Faupel, which relies on a reference electrode. However, while applicant alleges the modification would render Faupel unable to obtain suitable data, no reasoning is provided as to how this outcome would occur. If for example a bandage is included to hold the electrode assembly in place, as specified by claim 1, it is unclear how this would interfere with the electrode’s ability to collect data as there is no specified need for the bandage to be placed between the electrode and the skin. Additionally, as no standard is specified to what degree the materials may or may not differ, there cannot be an assumption that the composite would interfere with an ability to obtain a reference. Finally, the only specification that Faupel provides for the selected “reference site” is that it may be [0036]: “a corresponding position on a mirror site (e.g. left arm vs. right arm) or an undiseased portion of the same organ or tissue, or other undiseased tissue.”. Pierart therefore provides motivation to combine, as choosing different tissue may require an adhesive of different strength to properly obtain a reference signal (see rejection above).
Conclusion
Huelman et al. (US20170354816A1) – a second skin contact layer comprising a second conductive adhesive composite that is different from the first conductive adhesive composite
Matsumura et al. (“Removal of adhesive wound dressing and its effects on the stratum corneum of the skin: comparison of eight different adhesive wound dressings”) – discloses using multiple adhesive types
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 2:00 - 6:00 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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