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
Applicant’s arguments, see pg. 1 of Remarks, filed 05/29/2026, with respect to Objections to the Specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant’s arguments, see pg. 1 of Remarks, filed 05/29/2026, with respect to Objections to the Drawings have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant’s arguments, see pg. 1 of Remarks, filed 05/29/2026, with respect to Objections to the Drawings have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant’s arguments, see pg. 1-2 of Remarks, filed 05/29/2026, with respect to the rejection of claim 1 under 35 USC 112(a) have been fully considered and are persuasive. The rejection of claim 1 under 35 USC 112(a) has been withdrawn.
Applicant’s arguments, see pg. 1-2 of Remarks, filed 05/29/2026, with respect to the rejection of claims 4, 12, 13, 14, and 22 under 35 USC 112(b) have been fully considered and are persuasive. The rejections of claims 4, 12, 13, 14, and 22 under 35 USC 112(a) have been withdrawn.
Applicant's arguments filed on pgs. 9 and 10 of remarks in regards to 35 USC 102 have been fully considered but they are not persuasive. The Examiner agrees that there are specific differences in the mechanisms for improving conduction between the electrode and skin surface. However, as disclosed in Pastoor, the detergent is intrinsic and infused in the electrode body (see Pastoor, para. [0012]: “the electrode body comprises a conductive silicone material…and a detergent for facilitating a flow of ions through the conductive silicone material”); However, claim 9 of the claims, filed on 01/07/2025, do not specify any recited differences to distinguish from the claims from the prior art. Therefore, the rejection of claim 9 and its dependents is maintained. The amended claims (filed on 05/29/2026) will be given consideration (see “Response to Amendments” section below).
Applicant's arguments filed on pg. 10 of remarks in regards to 35 USC 103 have been fully considered but they are not persuasive. The Examiner disagrees that the modification of Pastoor in view of Ziebell is improper hindsight reconstruction. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, the Examiner disagrees that the principle operation of Pastoor would be changed by modification with the antistatic material of Ziebell. As detailed by the examiner on pg. 15 of the Office Action, filed on 01/05/2026, Pastoor discloses and relies upon an additive detergent as a conductive lubricant to create the conductive bridge. The examiner maintains that using the antistatic of Ziebell could be incorporated into the device of Pastoor to achieve improved conductivity. Further, it is shown that Ziebell discloses the antistatic as a silicone surface modifier, as shown in the figure on pg. 16 of the Office Action filed on 01/05/2026. On page 15 of the Office Action filed on 01/05/2026, it is disclosed that the electrode body of Pastoor is made of silicone and includes migratory additives. Additionally, page (or slide) 16 of Ziebell discloses the use of “self-lubrication additives,” and pg. 15 discloses the use of surface modifications in flexible sensors of wearable devices. These facts are sufficient to suggest to one of ordinary skill in the art that the additives of Ziebell could be combined with Pastoor. Therefore, the rejection of claim 1 and its dependents is maintained. The amended claims (filed 05/29/2026) will be given consideration (see “Response to Amendment” section below).
Response to Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor”) in view of Ziebell (“Technical Presentation: Third-Stream Additives that Modify LSR and HCR,” November 13, 2020 [online][Retrieved December 4, 2025]; RDAbott webpage; hyperlink titled “presentation”; [https://rdabbott.com/wp-content/uploads/2020/11/ISC2020-Third-Stream-Additives-for-LSR-and-HCR_20201113.pdf]).
Regarding claim 1, Pastoor discloses a self-wetting electrode (Fig. 1; para. [0026]; “an electrode body”; para. [0033]; “the dry silicone electrode”) for transcutaneous electrical stimulation (para. [0043; used for transcutaneous nerve stimulation”) comprising: a conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”); and a skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) disposed on the conductive backing layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102), wherein the skin contact layer is configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation (Fig. 1; the layer between the skin 104 and the electrode body 102; para. [0044]; "enables electrical signals to be received and/or transmitted from and/or to skin 104"), wherein the skin contact layer comprises silicone (para. [0012]: “The method includes removably coupling, with the electrode body, the electrode with the skin of the subject, the electrode body comprises a conductive silicone material.”) an antistatic material (para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") configured to form a layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 104 and the electrode body 102) when the skin contact layer (Fig. 1; the layer between the skin 104 and the electrode body 102) is in contact with a heat source (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat), wherein the heat source comprises heat from the skin (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat); Additionally, para. [0012] demonstrates that the body is the skin of the subject: “The method includes removably coupling, with the electrode body, the electrode with the skin of the subject”), and wherein the layer of conductive lubricant facilitates improved electrical contact between the self-wetting electrode and the skin (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 104 and the electrode body 102); Additionally, the recitation of “improved electrical contact” is merely a functional result of the layer of conductive lubricant, and does not limit the structure; Therefore, absent evidence of the contrary, the disclosed device of Pastoor would be able to improve the electrical contact between the electrode and the skin). However, Pastoor does not disclose wherein the antistatic material comprises migratory additives that are incompatible with silicone such that the antistatic material is configured to bloom to a skin facing surface of the skin contact layer.
Ziebell, in a power point presentation publicly available on RDAbbott’s webpage, discloses silicone material additives that self-lubricate and are antistatic. Ziebell, in the same field of endeavor as modified materials for wearable medical technology, discloses wherein the antistatic material comprises migratory additives (slide 23; NovaSperse ® silicone surface modifiers) that are incompatible with silicone (Slide 19 shows that the silicone surface modification is disposed to create a lubricant on the skin; The migratory additives are incompatible with the silicone since they bloom to the surface.) such that the antistatic material is configured to bloom to a skin facing surface of the skin contact layer (slide 23; “NovaSperse ® modifiers invisibly blooms to the surface of the silicone”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pastoor to include the migratory additive, antistatic material of Ziebell. One of ordinary skill in the art would have recognized that the detergent in the body of the electrode of Pastoor, could have been substituted for the antistatic surface modification of Ziebell. One of ordinary skill would have recognized that it would have been obvious to one of ordinary skill to try incorporating the migratory additives of Ziebell into the device of Pastoor, since Ziebell discloses using the silicone surface modification in wearable technology (see slides 15 and 16). Therefore, it would have been obvious to combine the additives of Ziebell with the device of Pastoor.
Regarding claim 2, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). Pastoor further discloses wherein the skin facing surface is not coated with hydrogel or liquid (Fig. 1; para. [0026]; "dry silicone electrode"; para. [0004]; " Dry electrodes rely on the natural salt and/or sweat on the skin of the subject to provide a flow path for the electrical signals transmitted to and/or received from the skin of the subject"; dry electrodes are not coated with hydrogel or liquid).
Regarding claim 3, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). Pastoor further discloses wherein the skin contact layer is conductive (Fig. 1; para. [0026];" Electrode body 102 includes a conductive silicone material").
Regarding claim 4, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). Pastoor further discloses wherein the self-wetting electrode is a dry-electrode (para. [0026]: “. The present patent application provides conductive particles filled dry silicone electrode 100 with detergent additives.”).
Regarding claim 6, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). Pastoor further discloses wherein the heat source is body heat of the user (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat); para. [0034]; “the modified silicone is configured to absorb/drag water from sweat in contact with the skin.”; the heat from the body induces sweat, which is absorbed by the detergent).
Regarding claim 7, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). Pastoor further discloses wherein the antistatic material forms a layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) when the self-wetting electrode (Fig. 1; the layer between the skin 104 and the electrode body 102) is placed on the skin for a period of time (Fig. 1; electrode body 102 is shown in contact with the skin 104). However, Pastoor does not specifically describe the antistatic material configured to bloom to a skin facing surface of the skin contact layer.
Ziebell, in a power point presentation presented at the 2020 International Silicone Conference, discloses silicone material additives that self-lubricate and are antistatic. Ziebell, in the same field of endeavor as modified materials for wearable medical technology, discloses wherein the antistatic material (slide 20; “NovaSperse ®” “Silicone surface modification – antistatic”) is configured to bloom to a skin facing surface of the skin contact layer (slide 23; NovaSperse ® modifiers invisibly blooms to the surface of the silicone”; see fig. below.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pastoor to include the migratory additives and antistatic material of Ziebell. One of ordinary skill in the art would have recognized that the detergent in the body of the electrode of Pastoor, could have been substituted for the antistatic surface modification of Ziebell. One of ordinary skill would have recognized that it would have been obvious to one of ordinary skill to try incorporating the migratory additives of Ziebell into the device of Pastoor, since Ziebell discloses using the silicone surface modification in wearable technology (see slides 15 and 16). Therefore, it would have been obvious to combine the additives of Ziebell with the device of Pastoor.
Regarding claim 8, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). Pastoor further discloses wherein the antistatic material (para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") is configured to stop blooming to the skin facing surface after the layer of conductive lubricant (para. [0007]; “the electrolytic sweat layer accumulates between the skin and the dry electrode”) after the layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 104 and the electrode body 102) substantially covers the skin facing surface (para. [0032]; “the detergent is configured to absorb water”; when the entire area and depth of the interface has absorbed water, it will reach its limit and stop. The salt-bridge layer will form on the electrode body 102 and skin 104 interface) of the skin contact layer (The layer between the electrode body 102 and the skin 102 would be substantially covered by the absorbed water (lubricant) once the limit is reached. Substantially is a broad term, and is interpreted as being enough coverage to improve conductivity).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor”), Ziebell (“Technical Presentation: Third-Stream Additives that Modify LSR and HCR,” November 13, 2020 [online][Retrieved December 4, 2025]; RDAbott webpage; hyperlink titled “presentation”; [https://rdabbott.com/wp-content/uploads/2020/11/ISC2020-Third-Stream-Additives-for-LSR-and-HCR_20201113.pdf]), and Paz et al. (US 20210138232 A1, “Paz”)
Regarding claim 5, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 1 (see above). However, neither reference expressly discloses wherein the skin contact layer comprises silver chloride.
Paz, in the same field of endeavor of transcutaneous electrical stimulation, discloses a wearable device with electrodes on the skin. Paz discloses wherein the skin contact layer comprises silver chloride (para. [0034]: “Each electrode consists of an electrically conductive electrolyte gel and a silver/silver chloride conductor. The gel typically contains potassium chloride—sometimes silver chloride as well—to permit electron conduction from the skin to the wire and to the electrocardiogram.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pastoor to further include a silver-chloride skin contact layer, as disclosed by Paz. One of ordinary skill would have recognized that silver-chloride is a known material for promoting conductivity between the electrode and skin. Since Paz discloses using this material between the skin and electrode to improve conductivity, it would have been obvious to include a conductive silver-chloride layer in the device of Pastoor.
Claims 9-14, 16, 17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor”) in view of Ziebell (“Technical Presentation: Third-Stream Additives that Modify LSR and HCR,” November 13, 2020 [online][Retrieved December 4, 2025]; RDAbott webpage; hyperlink titled “presentation”; [https://rdabbott.com/wp-content/uploads/2020/11/ISC2020-Third-Stream-Additives-for-LSR-and-HCR_20201113.pdf]).
Regarding claim 9, Pastoor teaches a self-wetting electrode (Fig. 1; para. [0026]; “an electrode body”; para. [0033]; “the dry silicone electrode”) for transcutaneous electrical stimulation (para. [0043; used for transcutaneous nerve stimulation”;) comprising: a conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”); and a skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) disposed on the conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”), the skin contact layer configured to deliver electrical current from the conductive backing layer to the skin for transcutaneous electrical stimulation (Fig. 1; the layer between the skin 104 and the electrode body 102; para. [0044]; "enables electrical signals to be received and/or transmitted from and/or to skin 104"), the skin contact layer comprising silicone (para. [0012]: “The method includes removably coupling, with the electrode body, the electrode with the skin of the subject, the electrode body comprises a conductive silicone material.”) and an antistatic material (para. [0027]; the detergent in the electrode body 102 is antistatic; "electrode body 102 includes silicone material, electrical conductive particles, and detergent; para. [0032]; “The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge”) configured to form a layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) when the skin contact is in contact with the skin (Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat); Additionally, para. [0012] demonstrates that the body is the skin of the subject: “The method includes removably coupling, with the electrode body, the electrode with the skin of the subject”). However, Pastoor does not disclose where the antistatic material is configured to bloom to a skin facing surface of the skin contact layer.
Ziebell, in a power point presentation publicly available on RDAbbott’s webpage, discloses silicone material additives that self-lubricate and are antistatic. Ziebell, in the same field of endeavor as modified materials for wearable medical technology, discloses wherein the antistatic material (slide 20; “NovaSperse ®” “Silicone surface modification – antistatic”) is configured to bloom to a skin facing surface of the skin contact layer (slide 23; NovaSperse ® modifiers invisibly blooms to the surface (of the silicone”; see fig. below).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pastoor to include the migratory additive, antistatic material of Ziebell. One of ordinary skill in the art would have recognized that the detergent in the body of the electrode of Pastoor, could have been substituted for the antistatic surface modification of Ziebell. One of ordinary skill would have recognized that it would have been obvious to one of ordinary skill to try incorporating the migratory additives of Ziebell into the device of Pastoor, since Ziebell discloses using the silicone surface modification in wearable technology (see slides 15 and 16). Therefore, it would have been obvious to combine the additives of Ziebell with the device of Pastoor.
Regarding claim 10, Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein the layer of conductive lubricant is non-sticky and moisturizing (para. [0031]; "the soap or detergent may include alpha-olefin sulfonate"; para. [0026]; “Electrode 100 is soft and skin friendly due to the hydrophilic silicone material having moisture regulating properties”; Alternatively, para. [0056]; "The electrode body includes a conductive silicone material configured to enable uptake or diffusion of moisture from the skin of the subject over which the electrode body is disposed"; The uptake and then diffusion of moisture from the skin would be non-sticky and moisturizing since sweat can act as both a non-sticky and moisturizing lubricant.)
Regarding claim 11, Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein the layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) is configured to provide a higher electrical conductivity ([0011]; “a detergent configured to facilitate a flow of ions through the conductive silicone material”) between the skin contact layer and a skin (para. [0012]; “conductive silicone material; receiving and/or transmitting electrical signals from and/or to the skin of the subject via the conductive silicone material of the electrode body”) location where the self-wetting electrode is placed on as compared to the electrical conductivity between the skin contact layer and the skin location without the layer of conductive lubricant. Although Pastoor does not specifically disclose a higher conductivity with the detergent compared to without the detergent, Pastoor does disclose that his device is an improvement from dry electrodes without the detergent (para. [0010]; “an improved dry electrode with a low impedance skin interface”). Pastoor makes clear that the addition of the detergent improves the flow of ions, and thus conductivity (para. [0026]; “a detergent configured to facilitate a flow of ions through the conductive silicone material.”)
Regarding claim 12, Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein the layer of conductive lubricant (para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102) is configured to provide improved conductivity electrical conductivity between the skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) and a skin location (Fig. 1; the skin 106 where electrode body 102 is placed) and a skin location (Fig. 1; the skin 104 ) on which the self-wetting electrode is placed (para. [0008]; “Another application is electrical stimulation of the skin”).
Regarding claim 13, Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein an amount of antistatic material (para. [0027]; the detergent in the electrode body 102; "electrode body 102 includes silicone material, electrical conductive particles, and detergent") is sufficient to cause the layer of conductive lubricant to substantially cover the skin facing surface of the skin contact layer (para. [0031]; "In some embodiments, the soap or detergent are mixed with the conductive silicone material to form a homogeneous material”; The mixing of the detergent in the silicone and homogeneous dispersion covers the skin facing surface and exposes the skin to the detergent).
Regarding claim 14, , Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above), as well as a layer of conductive lubricant formed on the skin contact layer when the skin contact layer is in contact with the skin for a certain period of time ((para. [0032]; "the detergent is configured to absorb more than 20% by weight of water. The interaction of water with the ions (added by the detergent) is configured to function as a salt-bridge"; the salt-bridge formed is a layer between the skin 106 and the electrode body 102; Fig. 1; electrode body 102 is shown in contact with the skin 104, which is a part of the body 106 (which is a source of heat); Additionally, para. [0012] demonstrates that the body is the skin of the subject: “The method includes removably coupling, with the electrode body, the electrode with the skin of the subject”).) However, Pastoor does not expressly disclose wherein the antistatic material comprises migratory additives that are incompatible with silicone so as to cause the antistatic material to bloom to the skin facing surface.
Ziebell discloses wherein the antistatic material comprises migratory additives (slide 23; NovaSperse ® silicone surface modifiers) that are incompatible with silicone so as to cause the antistatic material to bloom to the skin facing surface of the skin contact layer (slide 23; NovaSperse ® modifiers invisibly blooms to the surface (of the silicone”;) to form the layer of conductive lubricant (slide 19; NovaSperse shown in table with dynamic coefficient showing that NovaSperse creates a “’silky’ feel.”) when the skin contact layer is in contact with the skin for a certain period of time (Slide 19 shows that the silicone surface modification is disposed to create a lubricant on the skin; “Self-lubrication implies that it lubricates over a period of time (i.e., the surface in contact with the skin was not previously lubricated, and then it lubricates over time; The migratory additives are incompatible with the silicone since they bloom to the surface to form a layer of conductive lubricant.)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pastoor to include the migratory additives and antistatic material of Ziebell. One of ordinary skill in the art would have recognized that the detergent in the body of the electrode of Pastoor, could have been substituted for the antistatic surface modification of Ziebell. One of ordinary skill would have recognized that it would have been obvious to one of ordinary skill to try incorporating the migratory additives of Ziebell into the device of Pastoor, since Ziebell discloses using the silicone surface modification in wearable technology (see slides 15 and 16). Therefore, it would have been obvious to combine the additives of Ziebell with the device of Pastoor.
Regarding claim 16, Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein the conductive backing layer (Fig. 1; the layer between 110 and 102; para. [0044]; “Electrical coupling 110 is electrically coupled to electrode body 102 such that it enables electrical signals to be received and/or transmitted from and/or to skin 104; In some embodiments, additional components and/or layers of material are disposed between electrical coupling 110 and/or electrode body 102”; para. [0044]; " a portion of electrical coupling 110 may be made of a metallic material"). It should be noted that the metallic portion of electrical coupling meets the broadest reasonable interpretation of a metallic foil since it is a thin layer of metal. Further, Pastoor discloses that there may be additional conductive layers and that a portion is metallic. This layer is enough to be considered a foil given the broadest reasonable interpretation.
Regarding claim 17 Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein the skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) comprises a conductive filler (The detergent falls into the broad category of a conductive filler; para. [0011] discloses where the detergent is conductive: “a detergent configured to facilitate a flow of ions through the conductive silicone material.”) dispersed substantially evenly throughout the skin contact layer (para. [0031]; “the soap or detergent are mixed with the conductive silicone material to form a homogeneous material”; homogeneous material reads on the limitation “dispersed substantially evenly” since substantially even dispersion is broadly claimed).
Regarding claim 21, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). Pastoor further discloses wherein the skin contact layer (Fig. 1; the layer of the electrode body 102 between the skin 104 and the electrode body 102) comprises a thickness of between 0.5mm and 10mm (para. [0047]; “hydrophilic silicone material (with detergent additives) sheet may have a thickness of 1 millimeter”).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor”), Ziebell (“Technical Presentation: Third-Stream Additives that Modify LSR and HCR,” November 13, 2020 [online][Retrieved December 4, 2025]; RDAbott webpage; hyperlink titled “presentation”; [https://rdabbott.com/wp-content/uploads/2020/11/ISC2020-Third-Stream-Additives-for-LSR-and-HCR_20201113.pdf]), and Karicherla et al. (US 2009/0249617, “Karicherla”).
Regarding claim 18, Pastoor, in combination with Ziebell, discloses the self-wetting electrode of claim 17 (see above in 103 rejection). However, neither reference discloses wherein the conductive filler material comprises of single wall carbon nanotubes.
Karicherla, concerned with the same problem of static buildup, discloses an implantable lead with antistatic material coating comprising carbon nanotubes. Karicherla discloses wherein the conductive filler material (para. [0011]; “good dispersion of the carbon nanotubes in the matrix”; shows that the nanotubes are fillers in the material matrix) comprises of single wall carbon nanotubes (para. [0029]; “The carbon nanotubes are highly conductive and therefore a very small loading of this material in a polymer such as those described above is sufficient to dissipate a buildup of static charges”).
It would have been obvious for one of ordinary skill in the art to combine the carbon nanotubes of Karicherla with the electrode of Pastoor since doing so would enhance the antistatic properties of the silicone electrode. Further, doing so would prevent the buildup of static charges on charge accumulating surfaces (see Karicherla para. [0007]), which is undesirable for the sensitive circuitry. Therefore, it would have been an obvious improvement to combine the particular features of Karicherla with Pastoor.
Regarding claim 19, Pastoor, in combination with Ziebell and Karicherla, discloses the self-wetting electrode of claim 18 (see above in 103 rejection). Karicherla further discloses wherein a loading of the single wall carbon nanotubes is between about 1% and about 5% (para. [0011]; Still further, preferably, the coating may comprise a carbon nanotube loading of 0.005% to 4.5%, by weight). (overlap; since .005 is outside the claimed range; make the case that the end range (4.5) falls within the range (check MPEP obviousness of ranges)).
It would have been obvious for one of ordinary skill in the art to combine the carbon nanotubes of Karicherla with the electrode of Pastoor since doing so would enhance the antistatic properties of the silicone electrode. Further, doing so would prevent the buildup of static charges on charge accumulating surfaces (see Karicherla para. [0007]), which is undesirable for the sensitive circuitry. Lastly, since Karisherla discloses using a specific range, one of ordinary skill would have found it obvious to use the same range for preventing static buildup. Therefore, it would have been an obvious improvement to combine the particular features of Karicherla with Pastoor.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Pastoor et al. (US 20180116546 A1, “Pastoor”), Ziebell (“Technical Presentation: Third-Stream Additives that Modify LSR and HCR,” November 13, 2020 [online][Retrieved December 4, 2025]; RDAbott webpage; hyperlink titled “presentation”; [https://rdabbott.com/wp-content/uploads/2020/11/ISC2020-Third-Stream-Additives-for-LSR-and-HCR_20201113.pdf]), and Wong et al. (US 2019/0134393 A1, “Wong”).
Regarding claim 22, Pastoor, in combination with Ziebell, discloses the self-wetting electrode from claim 9 (see 103 rejection above). However, neither reference discloses wherein the skin contact layer has a Shore hardness between about 35 A to about 65 A.
Wong, in the same field of endeavor of transcutaneous nerve stimulation, discloses a wearable electrode device. Wong discloses wherein the skin contact layer has a Shore hardness between about 35 A to about 65 A (para. [0025]; “The skin contact layer may have a Shore hardness between about 25 A to about 55 A”; para. [0044]; “The skin contact layer has a Shore A durometer of between about 30 A and about 50 A”).
It would have been obvious for one of ordinary skill in the art to combine the Shore hardness for the skin contact layer in Wong in the electrode body of Pastoor since doing so would result in adequate flexibility that allows the electrode to conform to the user’s wrist. This would improve user comfort and improve skin contact with the device during stimulation (see para. [0007] of Wong). It would have been obvious to try a Shore hardness within this range for the skin contact layer since the skin contact layer needs to be flexible enough to conform to the user’s wrist while still maintaining the structural integrity of the electrode.
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 OWEN LEWIS MARSH whose telephone number is (571)272-8584. The examiner can normally be reached 7:30am – 5pm (M-Th), 8am – noon (F).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Additionally, SPE Carl Layno may be reached at (571) 272-4949.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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