DETAILED ACTION
This action is pursuant to claims filed 5/27/2026. Claims 1, 3, 4, 7, 9-15, 18, and 19 are pending. A final action on the merits of claims 1, 3, 4, 7, 9-15, 18, and 19 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 .
Claim Objections
Claim 19 is objected to because of the following informalities: line 1 states “the side wall of the overhand” which appears to be a typographical error. This should be corrected to --the side wall of the overhang--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation "the interface between the cover layer and the first layer" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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, 18, and 19 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 pressure has not been applied, 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), 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), and wherein the overhang comprises a side wall arranged at a non-perpendicular angle relative to the surface of the first layer such that measurement sensitivity is increased with a focused diffusion path resulting from the non-perpendicular angled side wall (as seen in Fig. 4a, the overhang has a side wall that is non-perpendicular to the surface of the first layer – this angle inherently creates a focused diffusion path since it has the claimed shape which would increase measurement sensitivity since it directs sweat, which is conductive, and charges into the recess which is consistent with the instant application; the claim is not specific to what is being diffused or any other structure that provides for the increased sensitivity; additionally, “such that measurement sensitivity is increased with a focused diffusion path resulting from the non-perpendicular angled side wall” is a functional limitation that is a result of the angled side-wall structure and the electrode of Oziat is capable of being placed against the skin without being pressed to release the gel which maintains the claimed configuration and the non-perpendicular overhang would allow for sweat or charges to diffuse into the recess thus allowing for an increased measurement sensitivity in the same manner as the instant application).
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While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim.
While Oziat discloses that the base 13 is attached to the layer 112 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 112.
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).
Regarding claim 19, the Oziat/Cui combination discloses the medical electrode according to claim 1, wherein the side wall of the overhang is arranged at a non-perpendicular angle relative to the surface of the first layer such that a shear stress at the interface between the cover layer and the first layer is reduced from the non-perpendicular angled side wall (the side wall of the overhang is arranged at a non-perpendicular angle as seen in Oziat Fig. 4a – this inherently results in a reduced shear stress between the first layer and the angled side-wall when compared to a perpendicular side wall since the angles cause impacts to deflect up or down the angled wall where a perpendicular wall would not deflect the blow; again, this is a functional limitation that the electrode of the Oziat/Cui combination is capable of accomplishing).
However, Oziat does not disclose a direct contact interface between the cover layer and the first layer in the embodiment shown in Fig. 4A.
Oziat discloses an alternate embodiment as shown in Fig. 2A in which the layer 13 directly contacts the cover layer 111 forming an interface between the two layers. Oziat further states that the embodiments are not limited to the precise arrangement, structure, features, and aspects shown ([0120]). Oziat further states that the peripheral wall can have an inner diameter ranging from 2 mm to 50 mm, from 2 mm to 40 mm, from 2 mm to 30 mm, from 2 mm to 20 mm, from 2 mm to 10 mm, from 5 mm to 50 mm, from 10 mm to 50 mm, from 20 mm to 50 mm, from 30 mm to 50 mm, or from 40 mm to 50 mm ([0044]), and the plate can have a diameter ranging from 1 mm to 50 mm, from 1 mm to 40 mm, from 1 mm to 30 mm, from 1 mm to 20 mm, from 1 mm to 10 mm, from 5 mm to 50 mm, from 10 mm to 50 mm, from 20 mm to 50 mm, from 30 mm to 50 mm, or from 40 mm to 50 mm ([0081]). Thus, there are many cases in which the inner diameter of the side wall can directly contact the outer edge of the first layer plate. Therefore, it would have been an obvious matter of design choice to ensure the first layer and the cover layer directly interface as taught in Fig. 2A, since such a modification would have involved a mere change in the size of a component that Oziat already contemplates. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-4, 7, 9-15, 18, and 19 have been fully considered but are not persuasive. Applicant initially argues that the prior art of record does not disclose the non-perpendicular angle of the side wall increasing measurement sensitivity with a focused diffusion path and is instead directed to a dispenser designed to expel electrolytic paste from the recess. While Oziat is configured to expel the electrolytic gel when pressed, the structure of the device is still the same as that claimed and is capable of performing the claimed function.
The electrode of Oziat is capable of being placed or held against the skin without pressing down to expel the gel. If held against the skin without applying additional pressure, the angled side walls, which have an angle the same as those of the instant application, can facilitate diffusion of sweat into the space which means that sensitivity is then increased in the same manner as the instant application. The claim is not specific to what is being diffused into the space or any other structure that would provide for increased sensitivity other than the angled side walls that Oziat also discloses.
Applicant also argues that the claimed device is designed to permanently contain a second conductive layer within the recess. However, this is not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant additionally argues that one skilled in the art has no reason to place a permanent conductive polymer from the reference of Cui into the dispenser structure of Oziat. However, this is not persuasive. The rejection of record does not replace the conductive paste of Oziat for a permanent conductive polymer from Cui, but instead simply uses Cui to teach the composition of a conductive hydrogel. Oziat states that the electrolytic paste is an electrically conductive hydrogel ([0074]). Cui 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]). Cui additionally states that the hydrogel is flowable which maintains the functionality of the dispensable hydrogel of Oziat ([0170]). Modifying the composition of a conductive paste/hydrogel to be more conductive is well within the ordinary level of skill in the art and would be an obvious modification for one of ordinary skill in the art to make in light of Cui. Therefore, it would be obvious to combine hydrogel of Oziat with the composition as taught by Cui in order to improve electrical conductivity.
Applicant’s arguments that the angled side walls of Oziat are not specifically configured to increase measurement sensitivity are not persuasive. The applicant states that the geometry creates more effective diffusion paths for charge exchange which increase measurement sensitivity. Oziat has the same angled geometry and thus forms the more effective diffusion paths. This is an inherent result of the structure shown in Fig. 4a of Oziat.
Similarly, the argument against the angled walls reducing the shear stress are not persuasive. The angled side walls inherently reduce shear stress relative to a perpendicular side wall. An angled side wall would deflect impact while a perpendicular side wall would not. Fig. 4a of Oziat clearly shows the angled side walls which would deflect impact and thus reduce shear stress at the interface.
The device of Oziat has the claimed structure and is capable of performing the claimed functions. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim.
Therefore, the rejection of claim 1 remains.
The rejections of claims 3, 4, 7, 9-15, and 18-19 remain because the rejection of claim 1 remains.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/W.M./ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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