DETAILED ACTION
This action is pursuant to RCE filed 12/16/2025. Claims 1, 3, 4, 7, 9-15, and 18 are pending. A non-final action on the merits of claims 1, 3, 4, 7, 9-15, and 18 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/16/2025 has been entered.
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.
The factual inquiries 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.
Claim(s) 1, 3, 4, 7, 9-15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Oziat et al. (hereinafter ‘Oziat’, US 20210330232 A1) in view of Cui et al. (hereinafter ‘Cui’, US 20090005667 A1).
Regarding independent claim 1, Oziat discloses a medical electrode (electrode in Figs. 4A), comprising a base body (base body 112 in Fig 4A) on which an electrically conductive first layer (layer 13 in Fig. 4A; [0152]: the plate 13 is attached to the polymeric washer 112 and a fastener 14 is attached to the bottom of washer 112; [Abstract]: plate 13 is conductive) and a cover layer are arranged (cover layer 111 in Fig. 4a), wherein the cover layer comprises an overhang (overhang highlighted below) which partially covers the first layer ([0038]: the hole 113 can have a diameter from 0.5mm to 30mm; [0081]: the plate 13 can have a diameter from 1mm to 50mm – thus since the diameter of the plate can be larger than the diameter of the hole formed by the overhang, like when the plate is 1mm in diameter which is greater than the hole diameter of 0.5mm or when the plate is 50mm in diameter which is greater than the hole diameter of 30mm, the overhang partially covers the first layer, in the examples provided the overhang would be 0.25mm around or 10mm around, respectively) wherein the cover layer comprises a recess (reservoir 11 in Fig. 4A), wherein the medical electrode further comprises an electrically conductive second layer (layer 12; [Abstract]: layer 12 is made of electrolytic paste; [0064]: the electrolytic paste is conductive and can exhibit a variety of electrical conductivities) arranged on the first layer (layer 12 is arranged on layer 13 as seen in Fig. 4a), wherein the second layer comprises a polymer ([0074]: the electrolytic paste is an electrically conductive hydrogel; hydrogels are a network of hydrophilic polymer chains), wherein the second layer is arranged exclusively within the recess ([0127]: the schematic shown in Fig. 4a is the electrode in the “before use” state; [0152]: the reservoir is filled with the electrolytic paste; [0136]: the electrolytic paste resides in the reservoir and has sufficient viscosity to not flow out of the reservoir unless an external force is applied – the claim is not specific in what use case the electrode is in, and when not in use, the electrolytic paste of Oziat is entirely within the reservoir as shown in Fig. 4A), wherein an outward-facing surface of the second layer is spaced apart from an outward-facing surface of the cover layer (there is a very clear space in Fig. 4A between the top of the cover layer and the top surface of the electrolytic paste in Fig. 4a – furthermore, this is simply dependent upon how much paste is applied and in the case shown in Fig. 4a the reservoir is not completely filled), such that a free space is formed within the recess (free space formed between paste and overhang in Fig. 4a), and wherein the free space is sufficiently configured to protect the second layer from mechanical damage (“sufficiently configured to protect” is a functional limitation that has not been provided with any structure for accomplishing this function, furthermore protect has not been defined in the claim; paragraph [0086] of the instant application simply states “the second layer 105 does not completely fill the recess […] due to the recessed arrangement of the second layer 105 within the recess 108, the second layer 105 is protected against mechanical damage.” Oziat discloses the same structure, namely the second layer 12 not completely filling the reservoir 11 in Fig. 4a – thus the structure of Oziat can functionally protect the second layer the same way as the instant application).
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While Oziat discloses that the base 13 is attached to the layer 12 and the fastener 14 is arranged on the bottom of the layer 13, the embodiment shown in Fig. 4A is unclear whether the plate 13 is on or adjacent to the layer 12.
Oziat discloses an alternate embodiment as shown in Fig. 2A in which the layer 13 sits on top of the base layer 112 and fastener 14 penetrates through the layer 112 to attach to plate 13. Oziat discloses that combining the layer 112 with the fastener 14 allows for less risk of separation between the electrode components ([0144]). Fig. 2A clearly shows that the plate 13 is on top of the layer 112. Oziat further states that the embodiments are not limited to the precise arrangement, structure, features, and aspects shown ([0120]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the plate, base, and fastener arrangement of Fig. 2A with the embodiment shown in Fig. 4A such that the plate 13 is on the base 112 and the fastener penetrates through and combines with the base to prevent the risk of separation between the electrode components.
However, while the hydrogel is disclosed as being conductive, Oziat is silent to the polymers forming the hydrogel being conductive.
Cui teaches an electrode system including a flowable and cohesive surface contact element comprising a hydrophilic polymer with an electrolyte fluid ([Abstract]). This is very similar to the electrolytic paste that forms the hydrogel of Oziat. Cui further teaches that the electrical characteristics of the hydrogels can be improved through the incorporation of electrically conductive polymers ([0106]). Cui states that the conductive polymers can be successfully incorporated within a variety of hydrogel structures in order to improve the electrical conductivity ([0106]). It would be well within the level of ordinary skill in the art to codify the hydrogel of Oziat with the conductive polymer of Cui since Oziat explicitly discloses a wide range of potential conductivities for the hydrogel and states that the electrolytic paste mush be sufficiently conductive to reduce impedance to maintain a good signal (Oziat [0064]-[0065). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the conductive polymer taught by Cui with the conductive hydrogel of Oziat such that the hydrogel comprises a conductive polymer which would improve its the electrical characteristics.
Regarding claim 3, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the recess tapers or widens toward the base body (as seen in Fig. 4a, the bottom portion tapers toward the base and the top portion widens toward the base).
Regarding claim 4, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the overhang comprises a side wall (side wall 111 in Fig. 4a) arranged at an angle to the surface of the first layer that is (i) less than 80° or (ii) 110° to 170° (as seen in the annotated Fig. 4a, the angle between the base of the side wall to the surface of the first layer is between 110° to 170°).
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Regarding claim 7, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the electrically conductive polymer comprises PEDOT (Cui [0106]: the conductive polymer can be PEDOT).
Regarding claim 9, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the base body comprises a flexible polymer substrate (Oziat [0017]: the washer 112 is polymeric; [0061]: the washer is flexible).
Regarding claim 10, the Oziat/Cui combination discloses the medical electrode according to claim 1, further comprising a conductor track which is electrically conductively connected to the first layer (the track is the connection point between the fastener 14 and the plate 13 in Fig. 2A; [0014]: the plate allows electrical communication between the scalp and the recording device; [0082] and [0084]: the snap fastener connects the electrode to the device; it is inherent that the track is electrically connected to the plate 13 since the signal must be collected by the plate and be conducted through the snap fastener to the recording device since snap fasteners are known in the art to be electrical and mechanical couplings).
Regarding claim 11, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the overhang is arranged and configured to mechanically stabilize the first layer (“configured to mechanically stabilize” is a functional limitation that is not provided any structure; the overhang of Oziat protects from an outside force as it would block sideways forces from impacting the first layer, thus it functionally provides for mechanical stabilization; [Abstract]: foam forms the walls that form the overhang; [0049]: the foam can be resilient; [0053]: the foam can be high density – thus the walls are capable of providing mechanical stabilization to the first layer if the electrode is impacted in the locations the overhang walls are present).
Regarding claim 12, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the overhang is arranged and configured to enable an electrical charge exchange between a liquid external medium and the first layer and/or optionally the second layer from different directions (the enablement of electrical charge exchange between an external medium and the first layer is due to the shape of the overhang as shown in Figs. 3 and 4 and described in paragraphs [0083] and [0084] of the instant application; the instant application does not describe any other structure that demonstrates how the charge exchange takes place; therefore, because the overhang of Oziat forms an angled funnel, Oziat is capable of directing electrical charge exchange between an external liquid medium to the hydrogel and/or the first layer).
Regarding claim 13, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the overhang is arranged and configured to protect the base body against the penetration of liquid (Oziat [Abstract]: the peripheral wall, which forms the overhang, is a foam material; [0056]: the foam is a closed cell foam that does not absorb water and can therefore be stored without concerns for environmental humidity – thus liquid does not penetrate the foam to reach the base).
Regarding claim 14, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the edge of the first layer is substantially completely covered by the cover layer ([0038]: the hole 113 can have a diameter from 0.5mm to 30mm; [0081]: the plate 13 can have a diameter from 1mm to 50mm – thus since the diameter of the plate can be larger than the diameter of the hole formed by the overhang of the cover layer, like when the plate is 1mm in diameter which is greater than the hole diameter of 0.5mm or when the plate is 50mm in diameter which is greater than the hole diameter of 30mm, the overhang of the cover layer covers the entire edge of first layer, in the examples provided the coverage would be 0.25mm around or 10mm around, respectively – “covered” is a broad term that does not require direct contact).
Regarding claim 15, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the medical electrode is configured within a device that is configured for electrical stimulation, detection, or ablation (Oziat [0012]: the electrode is for use with EEG or electrostimulation).
Regarding claim 18, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the conductive polymer comprises a polymer selected from the group consisting of a polyacetylene, a polyvinyl alcohol, a polyfluorene, a polyphenylene, a polyphenylene vinylene, a polypyrene, a polyazulene, a polynaphthalene, a polypyrrole, a polycarbazole, a polyindole, a polyazepine, a polyaniline, a polyacene, a polythiophene, a polythiophene vinylene, a polyphenylene sulfide, a polypyridine or functionalized derivatives, precursors or mixtures thereof (Cui [0106]: the conductive polymers can include polypyrrole).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-4, 7, 9-15, and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794