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 .
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.
Priority
The Examiner was able to find the priority documents filed. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
Claims 1-2, 4-5, and 7-8 are amended in the response filed 03/20/2026. Claims 1-8 are under examination herein.
Response to Arguments
Applicant's arguments filed 03/20/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 5-6 that Burns does not teach the amended claim “wherein the attaching part is a sheet-shaped electrode attachable to a brain surface of a brain upon use”, but the Examiner disagrees. The Cambridge Dictionary defines attach as “to fasten, join, or connect something”. It is the Examiner’s position that the electrodes are attached to the brain, given that the electrode joins or connects with the brain, although through a puncturing fashion. Further, the applicant does not define the means of attachment that would prevent this interpretation. In other words, there is no configuration that excludes the description of Burns, such as the use of an adhesive for attaching the device (as argued on page 9 of the Remarks filed), which Burns does not teach. The system of Burns is still attached to the brain surface, via the puncture.
Applicant’s arguments filed 03/20/2026 have been fully considered but they are not persuasive. Applicant argues on page 11 that Burns does not teach “the metal layer is positioned between the first silicone layer and a second silicone layer… and overmolding a third silicone layer…”. This limitation is not present in the currently amended claims filed 03/20/2026. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a first silicone layer, second silicone layer, welded contact pads, etc) are not recited in the rejected claim(s). 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).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Burns (US 2021/0121687) in view of Hirata (US 2009/0228066).
Regarding claims 1 and 8, Burns teaches “A recording and/or stimulation neural electrode with an attaching part… (p.[0030] "The electrode 200 is configured for electrocorticographic (ECoG ) recordings", and Figure 3, which shows a sheet-shaped electrode),…: an insulating sheet whose one surface serves as an attaching surface to be attached to the brain surface (p.[0040], second silicone layer 412 acts as an insulating sheet with attaching surface) and a conductive wiring formed on a surface of the insulating sheet that is opposite to the attaching surface (p.[0041], metal layer 402 on opposite side of second silicone layer 412), wherein multi-point electrode parts of the conductive wiring are exposed from hole parts of the insulating sheet (p.[0041], first set of holes 414 in second silicone layer exposing electrode sites), and wherein the insulating sheet is an elastomer thin film having a thickness of 2 to 100 pm (p.[0040], second silicone layer 50-100 um thick, elastomeric), and the conductive wiring has a thickness of 10 pm or smaller (p.[0032], metal layer 5-25um, including <10um, e.g., 10um).” Burns also teaches “wherein the multi-point electrode parts are exposed from hole parts of the insulating sheet and contact the brain surface to secure an electrical connection to the brain surface and receive electric potentials or electric currents associated with brain activity, andwherein the recording and/or stimulation neural electrode records the electric potentials or electric currents by a measurement device electrically connected to the conductive wiring, or stimulates the brain by supplying and transmitting electric currents from a stimulator electrically connected to the conductive wiring electrically connected to the brain” in p.[0022,0030].
Burns does not teach that the attaching part is a sheet-shaped electrode attachable to a brain surface of a brain upon use”, but Hirata does. Hirata teaches the use of a sheet-shaped electrode attachable to a brain surface of a brain upon use, as shown in Fig. 1, 2a-2b, 5-6, and p.[00176]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sheet-shaped electrode of Hirata in Burns. As taught in Hirata, the use of the sheet-shaped electrode allows for application of an electrode with a “precise shape of the brain surface and whose thickness is uniform and thin” (p.[0029-0031]).
Regarding claim 8 specifically, the limitations of claim 1 are taught as described above. MPEP 2112.02 I states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The device of claim 1 would inherently perform the method of claim 8, and therefore the rejection of claim 1 teaches the rejection of claim 8.
Regarding claim 2, the limitations of claim 1 are taught as described above. Burns teaches the claimed limitation with the first silicone layer being the base material sheet, which is 50-100 um and an "elastomer thin film". The base material is tightly attached to the insulating sheet via glue, primers, heat, and calendaring as described in p.[0037, 0040]. Metal layer 402 (the conductive wiring) is attached to both the insulating sheet (the attaching part) as described in p.[0037,0040]. Therefore, Burns/Hirata teaches the claimed limitation as described.
Regarding claim 7, the limitations of claim 1 are taught as described above. Burns describes the use of a support film with the mesh that supports the base material sheet is attached to an area that extends from the attaching part to the opposite side of the multi-point electrode parts, as seen in Figure 4D, and further described in p.[0035]. Therefore, Burns/Hirata teaches the claimed limitation as described.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Burns (US Patent Publication 2021/0121687) and Hirata (US 2009/0228066) in view of Fujie (US Patent Publication 2018/0107244).
Regarding claim 3, the limitations of claim 2 are taught as described above. Burns/Hirata does not teach that the conductive wiring is a printed wiring. However, Fujie an analogous electrode device, teaches in Figure 12 and p.[0032] that conductive wiring can be printed for use in an electrode device. It would have been obvious to one of ordinary skill in the art to use a printed wiring in Burns, in view of Fujie. Using printed wiring to connect components of the device is known in the art and produces predictable results, as suggested by Burns, p.[0030]. Note further that traces 128 are known in the art to be typically printed, therefore suggesting that it would have been obvious to one of ordinary skill in the art before the effective filing date to use traces (or other printed wiring) within Burns/Hirata in view of Fujie.
Regarding claim 4, the limitations of claim 3 are taught as described above. Burns/Hirata does not explicitly describe that the base material is hydrophilized, however, Burns does describe that a plasma treatment is applied to the base material sheet on the conductive wiring side (the metal layer 402) in p.[0039,0041]. Note that a plasma treatment results in hydrophilization, and therefore teaches the limitation as described.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Burns (US Patent Publication 2021/0121687) and Hirata (US 2009/0228066) in view of Rogers (WIPO WO 2011/084450).
Regarding claim 5, the limitations of claim 1 are taught as described above. Burns does not teach that the insulating sheet is a styrene-based elastomer (Burns teaches the use of silicone as an insulating sheet), however, Rogers does in an analogous electrode design. Rogers teaches in p.[0027] that "A range of materials are useful for flexible or stretchable substrates of the devices of the invention... a material selected from the group consisting of... the flexible or stretchable substrate comprises PDMS, parylene, or polyimide". Note that PDMS is a type of styrene-based elastomer. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use PDMS (as taught in Rogers) instead of silicone, as taught in Burns. As Rogers recognizes in p.[0027], a range of materials are useful for flexible substrates for insulation based on the requirements for the electrode device, and is known to be an obvious substitute for silicone. Therefore, the limitation is taught by Burns/Hirata in view of Rogers.
Regarding claim 6, the limitations of claim 1 are taught as described above. Burns/Hirata does not explicitly teach that the attaching part has a bending stiffness of 1x10^3 Nm or lower, however, Rogers does in an analogous electrode design. Rogers teaches in p.[0016] that the electronic circuit and barrier layer (the attaching part) provide a net stiffness "optionally for some applications less than or equal to 1x10 GPa pm^4, " therefore teaching the limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Rogers in view of Burns. One of ordinary skill in the art would be motivated to find the routine and optimal bending stiffness of the neural electrode in order to provide the optimal tissue conformal contact, and such modifications produce predictable results (p.[0008] of Rogers). See MPEP 2144.05 II.
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 Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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