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 .
Election/Restrictions
Claims 4 and 6-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04 July 2026.
Claim Objections
Claim 16 is objected to because of the following informalities: in lines 8-9, “each microelectrode” should read --each microelectrode well--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vörös et al. (US PGPub No. 2013/0303873), hereinafter Vörös.
Regarding claim 1, Vörös discloses a flexible microelectrode array system (par. 0075: “PDMS-based stretchable microelectrode arrays (SMEA) for spinal cord stimulation are described”), comprising:
a plurality of microelectrode wells patterned therein; and a plurality of microelectrodes, each microelectrode located within a microelectrode well of the plurality of microelectrode wells, each microelectrode comprising a first flexible electrically conductive material; and a plurality of contact pad wells patterned therein, and a plurality of contact pads, each contact pad located within a contact pad well of the plurality of contact pad wells, each contact pad comprising a third flexible electrically conductive material (Fig. 6(a)-(b): electrode and contact pad wells filled with flexible conductive PDMS 34);
a plurality of microelectrode lead channels patterned therein, each microelectrode lead channel coupled to a microelectrode well of the plurality of microelectrode wells; and a plurality of microelectrode leads, each microelectrode lead located within a microelectrode lead channel of the plurality of microelectrode lead channels, each microelectrode lead comprising a second flexible electrically conductive material, each microelectrode lead electrically coupled to a microelectrode of the plurality of microelectrodes; wherein each contact pad electrically coupled to a microelectrode lead of the plurality of microelectrode leads (Fig. 6(d): electrodes and pads 44, 45 connected by conductive lead channel; par. 0026: “applying structures of an electrically conducting second conformable material to the first layer of conformable material to form electrodes and/or leads;” see also contact pads and electrodes coupled by leads in Figs. 11-13).
Regarding claim 2, Vörös discloses the system of claim 1 as described previously. Vörös further discloses wherein the flexible substrate is selected from the group consisting of: silicone, polydimethylsiloxane (PDMS), polyimide, and any combination thereof (par. 0077: “Polydimethylsiloxane (PDMS) was used as a substrate material because of its excellent biocompatibility and mechanical properties”).
Regarding claim 3, Vörös discloses the system of claim 1 as described previously. Vörös further discloses wherein the first, second, and third flexible electrically conductive materials are the same (Figs. 6(c)-(d): electrode wells, contact pad wells, and electrode leads made of the same cPDMS material).
Regarding claim 5, Vörös discloses the system of claim 1 as described previously. Vörös further discloses wherein the first, second, or third flexible electrically conductive material is selected from the group consisting of: a mixture of silicone and carbon nanotubes (CNTs), a mixture of PDMS and CNTs, CNT ink, a metallic ink silver ink, gold ink, aluminum ink, copper ink, and any combination thereof (par. 0077: “Conductive PDMS prepared by dispersing silver particles or carbon nanotubes in the PDMS matrix”).
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, 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.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vörös in view of Vörös et al. (WO 2019/115373), hereinafter Vörös ‘373.
Regarding claim 16, Vörös teaches a method for manufacturing a flexible microelectrode array system (par. 0026: “the present invention provides a process for the manufacture of an implantable device for the electrical and/or pharmaceutical stimulation of the central nervous system”), comprising:
coating and curing a first layer of PDMS (par. 0085: “A first layer (30-50 µm thick) of PDMS was spin coated at 3000 rpm for 30 s on the Kapton or gold layer and cured at 100° C. for 30 minutes on a hotplate”);
punching a plurality of microelectrode and contact pad wells into the first layer of PDMS (Fig. 6 and par. 0089: “Holes of 350 µm were manually punched through the PDMS layer 33 at the location of the pads and electrodes (FIG. 6(a))”);
adhering a second flexible substrate to the first layer of PDMS (par. 0089: “A second layer of PDMS was spin coated at 1200-1400 rpm for 30 s to make an insulation layer (FIG. 6(c))”);
flowing a flexible electrically conductive material into the plurality of microelectrode wells or into the plurality of contact pad wells, thereby filling the plurality of microelectrode wells and the plurality of contact pad wells with the flexible electrically conductive material (Fig. 6(b): cPDMS 34 flowed into electrode and contact pad wells);
and removing the first layer of PDMS from the wafer and the photoresist to thereby expose a first flexible substrate (par. 0089: “The array was removed from the carrier 31, 32”)
to thereby form:
a plurality of microelectrodes located between the first and second flexible substrates, each microelectrode located within a microelectrode well of the plurality of microelectrode wells; a plurality of microelectrode leads located between the first and second flexible substrates, each microelectrode lead located within a microelectrode lead channel of the plurality of microelectrode channels, each microelectrode lead electrically coupled to a microelectrode of the plurality of microelectrodes, and a plurality of contact pads located between the first and second flexible substrates, each contact pad located within a contact pad well of the plurality of contact pad wells, each contact pad electrically coupled to a microelectrode lead of the plurality of microelectrode leads (Fig. 6(d): electrodes and pads 44, 45 connected by conductive lead channel; par. 0026: “applying structures of an electrically conducting second conformable material to the first layer of conformable material to form electrodes and/or leads;” see also contact pads and electrodes coupled by leads in Figs. 11-13).
Vörös does not explicitly teach forming the plurality of microelectrode lead channels by lithographically patterning a photoresist on a wafer, casting the first layer of PDMS over the photoresist, and removing the first layer of PDMS from the wafer. However, in another embodiment, Vörös teaches a channel-forming process comprising lithographically patterning a photoresist on a wafer (Fig. 10(b) and par. 0094: “The structured carrier 31 can be produced either by making structures of photoresist like SU8 on a carrier like glass or silicon using standard photolithography or by wet etching, dry etching or laser ablating the carrier (FIG. 10(a) and (b))”);
coating and curing a first layer of PDMS to cover the wafer and the photoresist (par. 0094: “PDMS is first casted on a structured carrier whose structures correspond to the geometry of the desired microchannels”);
and removing the first layer of PDMS from the wafer (par. 0094: “The PDMS is then peeled off from the carrier. The obtained micro-structured PDMS layer is flipped and bonded on the back of a device 54, which may have been prepared according of one of the processes described before. The bonding of the two PDMS layers is made by first treating the surface to be bonded in air plasma, placing the layers against each other, pressing and waiting until the two layers are bonded (symbolized by connection 57). This results in horizontal channels 56 between the two layers”).
Additionally, in an analogous art, Vörös ‘373 teaches that curing non-conductive material before depositing and curing conductive material is an obvious alternative to depositing and curing conductive material and depositing and curing non-conductive material, or performing both curing processes simultaneously (par. 0046-0047: “In one embodiment, the conductive material in a non cured form (fluid or paste for instance) is deposited into the mould in the area delineating as the conductive area of the sensor device to be moulded. Then the non-conductive material in fluid form is deposited around the conductive area in the non-conductive area. Alternatively, the non- conductive material is deposited in the mould, followed by the conductive material. Then the mould with the conductive and non-conductive material is cured. In another embodiment, it is possible to cure the conductive material before depositing the non-conductive material, and curing the non-conductive material subsequently, mutatis mutandis when the non-conductive material is introduced prior to the conductive material”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Vörös to form the microelectrode lead channels by lithographically patterning a photoresist on a wafer, coating and curing the first layer of PDMS to cover the wafer and the photoresist, and removing the first layer of PDMS from the wafer; as taught by Vörös’s second embodiment, since one of ordinary skill in the art would have recognized in light of Vörös ‘373’s teaching that substituting the known channel-forming technique taught by Vörös’s second embodiment for the channel-forming technique in the method of Vörös would have yielded predictable results, namely, a method in which the non-conductive material (in this case, the first and second flexible substrates) was deposited and cured before depositing and curing the conductive material.
Regarding claim 17, the combination teaches the method of claim 16 as described previously. Vörös further teaches wherein the second flexible substrate is selected from the group consisting of: silicone, PDMS, polyimide, and any combination thereof (par. 0089: “A second layer of PDMS”).
Regarding claim 18, the combination teaches the method of claim 16 as described previously. Vörös further teaches the limitations of claim 18 for the same reasons set forth in the rejection of claim 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Costes et al. (WO 2013/187973) teaches a known soft lithographic method for fabricating microchannels, involving preparing a master mold using photoresist, casting a PDMS replica, removing the PDMS replica from the mold, and punching apertures in the PDMS replica as required.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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