DETAILED ACTION
This action is pursuant to the claims filed on June 24, 2024. Claims 1-15 are pending. A first action on the merits of claims 1-15 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 1-6, and 10-11 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 conductive elastomer forming the telescoping walls, [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 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 6, the limitation is directed to the result of using the sensor since some of the released conductive material disposed between the opening (672) of the reservoir can be absorbed back into the reservoir once the applied force unto the skin is removed, closing and scooping the conductive material disposed between opening (672).
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.).
Claims 7-9 and 12-15 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 backing layer (backing 612);
at least one 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 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 on 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 material 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 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.
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]).
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 material 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
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 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.
Conclusion
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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/EUN HWA KIM/Primary Examiner, Art Unit 3794 2/18/2026