DETAILED ACTION
This action is pursuant to the claims filed on February 20, 2026. Claims 1-5, and 7-21 are pending. Claim 6 is canceled. A final action on the merits of claims 1-5 and 7-21 is as follows.
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 . 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 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.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 10-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bachelder et al. (hereinafter ‘Bachelder’, U.S. PGPub. No. 2023/0000416), and further in view of Sjaaheim (U.S. PGPub. No. 2015/0327789).
In regards to independent claim 1 and claim 4, Bachelder discloses a sensor (electrode 600 in Figs. 6A-6C), comprising:
an electrode assembly (the reservoir system comprising an interior reservoir 670 filled with a conductive fluid or gel 674 and the telescoping walls forming the reservoir 670 comprising conductive elastomer, [0090]) including an electrode well (the pressure release reservoir forming the telescoping walls, [0090]) and a backing layer (backing 12, [0090]); and
an electrically conductive material (electrically conductive fluid or gel 674) disposed within the electrode well (electrically conductive fluid or gel 674 disposed within the reservoir 70).
However, Bachelder does not disclose an electrode that is disposed within the electrode well against the backing layer.
In an alternate embodiment of Fig. 3A, Bachelder discloses an electrode (electrodes 38A and 38B in Fig. 3A) disposed within a reservoir (30A and 30B) and is against a backing (each electrodes 38A and 38B are against the backing layer 12, [0084]-[0085]). Although Bachelder’s embodiment of Figs. 6A-6C discloses the electrodes being on an external surface of the reservoir, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrode assembly of embodiment of Figs. 6A-6C such that the electrodes are disposed within the reservoir and against the backing layer as disclosed in the alternate embodiment of Fig. 3A since choosing one of the arrangements where electrodes are within or external to the reservoir for detecting electrical signals transmitted from the skin involves routine skill in the art ([0085]). The Examiner notes that this arrangement meets the claim limitation since the modified electrode is between the backing layer (12) and the electrically conductive gel (674).
However, Bachelder does not disclose abrasive particles, wherein the abrasive particles are configured to displace at least a portion of a layer on or of skin of a patient upon application of the sensor to the skin of the patient.
Sjaaheim teaches an electrode for measuring bio-potential on a skin surface of a subject similar to Bachelder (abstract). Sjaaheim further teaches providing a conductive fluid stored in a reservoir (see for example, Fig. 5), wherein the conductive fluid is released upon sufficient pressure ([0043]). Sjaaheim teaches incorporating small abrasive particles such as various types of crystals enhance the abrasive effect of the fluid ([0045]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrically conductive material of Bachelder and incorporate the abrasive particles as taught by Sjaaheim, as doing to enhances the abrasive effect of the fluid such that the abrasive particles forming a layer over a skin are sufficient to abrade a layer of dead skin cells (the stratum corneum) to reduce the impedance of the skin ([0036]).
In regard to claims 2 and 3, the limitations are directed to the result of using the sensor of Bachelder/Sjaaheim combination since the abrasive particles within the conductive material (674 in Fig. 4C, Bachelder) are configured to wet the surface of the skin (as it is expelled from the openings 672 of the reservoir 670) and the electrode wall (the layer forming the reservoir 670 are configured to open to release the conductive fluid as shown in Bachelder) and the abrasive particles are configured to displace the at least a portion of the layer on the surface of the skin to increase a surface area of wetting between the electrically conductive material and the skin of the patient (the conductive fluid 674 and the abrasive particles within the conductive fluid 674 form a layer between the skin and the outer surface of the wall layer forming the reservoir 670; note that the released conductive fluid 674 increases the surface area of wetting between the reservoir and the skin).
In regards to claim 5, Bachelder/Sjaaheim combination further discloses wherein the electrically conductive material comprises an electrolytic gel ([0088]: an electrically conductive fluid or gel 674 contained within the interior of the reservoir).
In regards to claim 10, the limitation is directed to the result of using the sensor of Bachelder/Sjaaheim combination as applying force against the skin of the wearer causes deformation by the opening (672) of the electrode well/reservoir (670) to release the abrasive particles within conductive material and some of the conductive material is still contained in the electrode well/reservoir (670).
In regards to claim 11, Bachelder/Sjaaheim combination further wherein the sensor is at least one of an electroencephalogram sensor or an electrocardiogram sensor ([0041]: The wearable sensor apparatus may comprise one or more of an EEG sensor, an EKG sensor, or an EMG sensor.).
In regards to claims 18-19, Bachelder/Sjaaheim combination further wherein the electrode assembly comprises a sponge within the electrode well ([0090]: a resiliently compressible material comprising a compressible foam or a compressible open-celled foam), wherein the electrode well is defined by the foam layer and the backing layer to retain the electrically conductive gel and the modified abrasive particles (Fig. 7A illustrates the backing layer 612 and the resiliently compressible material define or form in part the reservoir 670 to retain the gel of Bachelder and the abrasive particles of Sjaaheim). The Examiner further notes that the extending portion comprising opening (672) and its sponge portion extends out of the reservoir (670).
In regards to claim 20, Bachelder/Sjaaheim combination further discloses wherein the electrode comprises a conductive ink printed on the backing layer ([0087]: “the electrodes 60A and 60B may be fabricated from a conductive metal or alternatively, a flexible material which is coated or layered with a conductive material”; the coating/layered conductive material describes a conductive ink capable of being printed on the backing layer 12).
Claims 7-9, 12-17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bachelder and Sjaaheim, and further in view of Carim (U.S. PGPub. No. 2005/0015134).
In regards to claim 7, Bachelder/Sjaaheim combination further wherein the electrode assembly comprises: a foam layer disposed on the at least a portion of the backing layer ([0090]: a resiliently compressible material comprising a compressible foam or a compressible open-celled foam), wherein the electrode well is defined by the foam layer and the backing layer (Fig. 7A illustrates the backing layer 612 and the resiliently compressible material define or form in part the reservoir 670).
Bachelder/Sjaaheim combination further wherein the electrode assembly further comprises an adhesive disposed on at least a portion of the foam layer and configured to adhere the sensor to a patient and a peelable layer configured to contain the electrically conductive material within the electrode well and configured to releasably adhere to and cover an outer surface of the adhesive.
Carim teaches a general biomedical electrode (electrode 10 in Fig. 1-2) comprising a foam (foam 90) configured for attachment to a skin via a non-conductive pressure sensitive adhesive (adhesive 98. [0060]-[0061]). Carim further teaches a peelable layer (release liner 50) disposed on the non-conductive pressure sensitive adhesive (adhesive 98) so that once the release liner is released, the electrode can be attached onto the skin ([0061]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the electrode assembly of Bachelder/Sjaaheim combination to provide an adhesive and its respective peelable layer along the lower surface of the electrode assembly as taught by Carim which would be disposed below the layer forming the telescoping electrode layer and the foam which is disposed in it, as doing so allows the electrode assembly to attach to the skin ([0061]).
In regard to claims 8 and 9, Bachelder/Sjaaheim/Carim combination further discloses a sponge/foam layer disposed at least partially within the electrode well and configured to release the electrically conductive gel upon application of the sensor to the skin of the patient ([0090]: compressible open-celled foam which holds the conductive fluid or gel).
In regards to independent claim 12, Bachelder discloses a sensor (electrode 600 in Figs. 6A-6C), comprising:
an electrode assembly (the reservoir system comprising an interior reservoir 670 filled with a conductive fluid or gel 674 and the wall formed from conductive elastomer, [0090]) including an electrode well (conductive elastomer including the opening 672, [0090]), the electrode assembly comprising:
a backing layer (backing 612);
an electrode disposed on the backing layer (a conductive elastomer forms the reservoir 670, [0088]);
a foam layer disposed on the at least a portion of the backing layer ([0090]: “a resiliently compressible material may be positioned between the telescoping elements of the reservoir 670… a compressible foam, a compressible open-celled foam…”), wherein the electrode well is defined by the foam layer and the backing layer (Fig. 7A illustrates the backing layer 612 and the resiliently compressible material define or form in part the reservoir 670); and
an electrically conductive material disposed within the electrode well (electrically conductive fluid or gel 674 disposed within the reservoir 670).
However, Bachelder does not disclose wherein the electrode is positioned between the electrically conductive gel and the backing layer.
In an alternate embodiment of Fig. 3A, Bachelder discloses an electrode (electrodes 38A and 38B in Fig. 3A) disposed within a reservoir (30A and 30B) and is against a backing (each electrodes 38A and 38B are against the backing layer 12, [0084]-[0085]). Although Bachelder’s embodiment of Figs. 6A-6C discloses the electrodes being on an external surface of the reservoir, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrode assembly of embodiment of Figs. 6A-6C such that the electrodes are disposed within the reservoir and against the backing layer as disclosed in the alternate embodiment of Fig. 3A since choosing one of the arrangements where electrodes are within or external to the reservoir for detecting electrical signals transmitted from the skin involves routine skill in the art ([0085]).The Examiner notes that this arrangement meets the claim limitation since the modified electrode is between the backing layer (12) and the electrically conductive gel (674).
However, Bachelder does not disclose abrasive particles, wherein the abrasive particles are configured to displace at least a portion of a layer on or of skin of a patient upon application of the sensor to the skin of the patient.
Sjaaheim teaches an electrode for measuring bio-potential on a skin surface of a subject similar to Bachelder (abstract). Sjaaheim further teaches providing a conductive fluid stored in a reservoir (see for example, Fig. 5), wherein the conductive fluid is released upon sufficient pressure ([0043]). Sjaaheim teaches incorporating small abrasive particles such as various types of crystals enhance the abrasive effect of the fluid ([0045]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrically conductive material of Bachelder and incorporate the abrasive particles as taught by Sjaaheim, as doing to enhances the abrasive effect of the fluid such that the abrasive particles forming a layer over a skin are sufficient to abrade a layer of dead skin cells (the stratum corneum) to reduce the impedance of the skin ([0036]).
Bachelder/Sjaaheim combination further wherein the electrode assembly further comprises an adhesive disposed on at least a portion of the foam layer and configured to adhere the sensor to a patient and a peelable layer configured to contain the electrically conductive material within the electrode well and configured to releasably adhere to and cover an outer surface of the adhesive, and wherein the electrically conductive gel is positioned between the peelable layer and the electrode.
Carim teaches a general biomedical electrode (electrode 10 in Fig. 1-2) comprising a non-conductive pressure sensitive adhesive (adhesive 98, [0060]-[0061]). Carim further teaches a peelable layer (release liner 50) disposed on the non-conductive pressure sensitive adhesive (adhesive 98) so that once the release liner is released, the electrode can be attached onto the skin ([0061]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the electrode assembly of Bachelder/Sjaaheim combination to provide an adhesive and its respective peelable layer along the lower surface of the electrode assembly as taught by Carim which would be disposed below the layer forming the telescoping electrode layer and the foam which is disposed on it, as doing so allows the electrode assembly to attach to the skin ([0061]). The Examiner notes that the resulting combination provides for the electrically conductive gel to be positioned between the peelable layer and the electrode.
In regard to claims 13 and 14, the limitations are directed to the result of using the sensor of Bachelder/Sjaaheim combination since the abrasive particles within the conductive fluid (74 in Fig. 4C as shown in Bachelder) is configured to wet the surface of the skin (as it is expelled from the openings 72 of the reservoir 70) and the electrode wall (the layer forming the reservoir 70 as shown in Bachelder) and the abrasive particles are configured to displace the at least a portion of the layer on the surface of the skin to increase a surface area of wetting between the electrically conductive gel and the skin of the patient (the conductive fluid 74 and the abrasive particles within the conductive fluid 74 form a layer between the skin and the outer surface of the wall layer forming the reservoir 70; note that the released conductive fluid 74 increases the surface area of wetting between the reservoir and the skin).
In regards to independent claim 15, Bachelder discloses a method, comprising:
positioning a sensor on a surface of a skin of a patient (see Fig. 1; the backing 12 is positioned on a user’s head), the sensor comprising:
an electrode assembly (the reservoir system comprising an interior reservoir 670 filled with a conductive fluid or gel 674 and the telescoping walls forming the reservoir 670 comprising conductive elastomer, [0090]) including an electrode well (the conductive elastomer forming the telescoping walls, [0090]) and a backing layer (backing 12); and
an electrically conductive material (electrically conductive fluid or gel 674) disposed within the electrode well (electrically conductive fluid or gel 674 disposed within the reservoir 70);
applying a force to the sensor in a direction towards the surface of the skin, wherein the application of the force causes the conductive material to displace at least a portion of a layer on the surface of the skin of the patient ([0090]: reservoir 670 may be actuated by pressure changes in the chamber).
However, Bachelder does not disclose wherein the electrode is disposed within the electrode well against the baking layer; and the electrode is positioned between the electrically conductive gel and the backing layer.
In an alternate embodiment of Fig. 3A, Bachelder discloses an electrode (electrodes 38A and 38B in Fig. 3A) disposed within a reservoir (30A and 30B) and is against a backing (each electrodes 38A and 38B are against the backing layer 12, [0084]-[0085]). Although Bachelder’s embodiment of Figs. 6A-6C discloses the electrodes being on an external surface of the reservoir, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrode assembly of embodiment of Figs. 6A-6C such that the electrodes are disposed within the reservoir and against the backing layer as disclosed in the alternate embodiment of Fig. 3A since choosing one of the arrangements where electrodes are within or external to the reservoir for detecting electrical signals transmitted from the skin involves routine skill in the art ([0085]).The Examiner notes that this arrangement meets the claim limitation since the modified electrode is between the backing layer (12) and the electrically conductive gel (674).
However, Bachelder does not disclose the electrically conductive material comprising abrasive particles.
Sjaaheim teaches an electrode for measuring bio-potential on a skin surface of a subject similar to Bachelder (abstract). Sjaaheim further teaches providing a conductive fluid stored in a reservoir (see for example, Fig. 5), wherein the conductive fluid is released upon sufficient pressure ([0043]). Sjaaheim teaches incorporating small abrasive particles such as various types of crystals enhance the abrasive effect of the fluid ([0045]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrically conductive material of Bachelder and incorporate the abrasive particles as taught by Sjaaheim, as doing to enhances the abrasive effect of the fluid such that the abrasive particles forming a layer over a skin are sufficient to abrade a layer of dead skin cells (the stratum corneum) to reduce the impedance of the skin ([0036]).
However, Bachelder/Sjaaheim combination does not disclose applying a force to the sensor to adhere the sensor to the surface about a perimeter of the electrode well thereby sealing the electrode well.
Carim teaches a general biomedical electrode (electrode 10 in Fig. 1-2) comprising a non-conductive pressure sensitive adhesive (adhesive 98) to sealingly attach the biomedical electrode to a skin ([0060]-[0061]). The examiner notes that the concept of providing an adhesive to securely attach electrodes against the skin involves routine skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art to modify the electrode assembly of Bachelder/Sjaaheim combination to provide an adhesive along the lower surface of the electrode assembly as taught by Carim so as to apply a force to adhere the electrode against the skin ([0061]) as doing so involves routine skill in the art and a predictable result would ensue.
With respect to the limitation “constraining movement of the electrically conductive gel within a space defined by the electrode well and the skin”. The Examiner notes that during application of pressure as shown in Fig. 6B of Bachelder, the electrically conductive gel (674) is mostly contained within the reservoir (670).
In regards to claim 16, Bachelder/Sjaaheim/Carim combination further discloses wherein applying a force to the sensor in the direction towards the surface of the skin comprises compressing a sponge within the electrode well ([0090]: the electrically conductive fluid or gel 674 may be disposed in a resiliently compressible material or a compressible foam or a compressible open-celled foam so an applied force against the skin during use would inherently cause the compressible foam or compressible open-celled form to be compressed within the reservoir 670).
In regards to claim 17, in view of the combination in claim 16/15/14, Carim further teaches removing a liner from a sensor to expose a patient-contacting adhesive prior to applying the sensor (release liner 50 is removes an adhesive 98 so the electrode can be attached onto the skin, [0061]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the method and provide a liner, and removing the liner from a patient-contacting adhesive as taught by Carim which would be disposed below the layer forming the telescoping electrode layer and the foam which is disposed on it, as doing so allows the electrode assembly to attach to the skin ([0061]). The Examiner notes that as the force is applied towards the skin during application, the sponge is configured to be decompressed as a result of use.
In regards to claim 21, Bachelder/Sjaaheim combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Bachelder/Sjaaheim combination does not disclose wherein the electrode well comprises a perimeter comprising an adhesive plane, and wherein the perimeter defines a patient contact area of the electrically conductive gel.
Carim teaches a general biomedical electrode (electrode 10 in Fig. 1-2) comprising a non-conductive pressure sensitive adhesive for contacting a surface of a skin (adhesive 98. [0060]-[0061]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the electrode assembly of Bachelder/Sjaaheim combination to provide an adhesive along the lower surface of the electrode assembly as taught by Carim as doing so allows the electrode assembly to better attach to the skin ([0061]). The Examiner notes that providing the adhesive along the lower surface of the reservoir of Bachelder defines a patient contact area of the electrically conductive gel because the adhesive surrounds the opening to define the perimeter of the opening in which the electrically conductive gel is exposed.
Response to Arguments
Applicant’s Remarks filed on May 20, 2026 is fully acknowledged.
With respect to independent claims 1, 12 and 15, in response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the abrasive particles of Sjaaheim into the conductive gel of Bachelder, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Sjaaheim teaches that incorporating abrasive particles enhances the abrasive effect of the fluid such that the abrasive particles forming a layer over a skin are sufficient to abrade a layer of dead skin cells (the stratum corneum) to reduce the impedance of the skin ([0036]). One of ordinary skill in the art would recognize that doing so would further benefit signal obtained from the sensor of Bachelder. Therefore, this argument is unpersuasive.
Applicant further argues that Bachelder/Sjaaheim combination fails to disclose, teach, or suggest, in part “a system in which an electrode is positioned between a backing layer and an electrically conductive gel with abrasive particles” as required in amended independent claim 1 and similarly recited in claims 12 and 15. The previous interpretation relied upon the embodiment of Figs. 6A-6C. Upon further consideration, Bachelder discloses an alternate embodiment in which an electrode (electrodes 38A and 38B in Fig. 3A) is disposed within a reservoir (30A and 30B) and is against a backing (each electrodes 38A and 38B are against the backing layer 12, [0084]-[0085]). Although Bachelder’s embodiment of Figs. 6A-6C discloses the electrodes being on an external surface of the reservoir, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrode assembly of embodiment of Figs. 6A-6C such that the electrodes are disposed within the reservoir and against the backing layer as disclosed in the alternate embodiment of Fig. 3A since choosing one of the arrangements where an electrode is within or external to the reservoir involves routine skill in the art and recognize that there is a reasonable expectation of success when the electrode is within the reservoir for detecting electrical signals transmitted from the skin ([0085]). Furthermore, this arrangement meets the claim limitation since the modified electrode is between the backing layer (12) and the electrically conductive gel (674).
Accordingly, the Examiner maintains the rejection of claims 1-6 and 10-11 under 35 U.S.C. 103 under Bachelder and Sjaaheim.
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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 7/6/2026
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