DETAILED ACTION
This action is pursuant to claims filed on 12/16/2024. Claims 22 are pending. A first action on the merits of claims 1-22 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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cantilever beam, latch, linkage mechanism, and structure that provides for microfluidic operation in claims 3 and 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites “the one of the wires.” It appears this should be --the wire-- since multiple wires have not been introduced.
Appropriate corrections are 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.
Claims 1-22 are 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 1 is rejected because “the flexible electrode” in line 5 lacks antecedent basis. For the purposes of compact prosecution, this will be interpreted as the flexible electrode sheet.
Claims 2-22 are rejected due to their dependance on claim 1.
Claim 6 is further rejected because “the part” in line 3 lacks antecedent basis. For the purposes of compact prosecution, this will be interpreted as a part of the craniotomy site.
Claim 9 is further rejected because it is unclear how a single wire comprises multiple wires. There is either a single wire or there are multiple wires, but a single wire does not comprise multiple wires. Based on claim 1, a single wire connects to a single electrode site. If that is the case it is unclear how multiple wires inside of a single wire are spaced but still connect to a single electrode. Similarly, it is unclear how a single electrode site comprises multiple electrode sites. A single entity does not comprise multiple entities of itself. There can be multiple present, but they are not comprised in the original single unit.
Claim 10 is rejected due to its dependance on claim 9.
Claim 11 is rejected because “the wires” in line 7 lacks antecedent basis. Only a single wire has been introduced in claim 1. For the purposes of compact prosecution, this will be interpreted as --the wire--.
Claim 14 is rejected it is unclear how a single wire can comprise an adhesion layer. A wire is a specific, known structure in the art. It is a metal drawn into a thin flexible thread or rod. It is unclear how a metal drawn into a thread or rod is intended to comprise an adhesion layer. Paragraph [0034] of the instant application states, “the wires in the wire layer 240 may be a film structure including a plurality of layers stacked in a thickness direction” as well as “the wire layer 240 may include a conductive layer and an adhesion layer stacked.” This is not consistent with the known structure of a wire, but is instead consistent with the structure of a conductive trace. The inconsistencies between claiming a “wire” and the claimed structure not being consistent with the structure of a “wire” as accepted in the art, renders the claim indefinite. For the purposes of compact prosecution, the “wire” of claim 14 will be treated as a trace. The examiner recommends amending the entire application to state --trace-- instead of “wire” because the structure described throughout the instant application is not consistent with the accepted definition of a wire.
Claims 15-16 are rejected due to their dependance on claim 14.
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) 1-13, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hettick et al. (hereinafter ‘Hettick’, US 20230120082 A1) in view of Cadwell (US 20200108246 A1).
Regarding independent claim 1, Hettick discloses a surface electrode for a central nervous system ([Abstract]: disclosed is a microelectrode assembly that is deployable to form a neural interface; [0053]: configured for implantation to a target site on the brain), comprising:
at least one implantable and flexible electrode sheet (thin-film micro-electrode array 105; [0053]: the array is configured for implantation to a target site on the brain; [0055]: the thin film microelectrode array has two lateral wings; [0013]: the lateral wings are flexible), wherein each of the at least one electrode sheet comprises:
a trace (electrical traces 101 in Fig. 1B and 505 in Figs. 5B-5E), located between a first insulating layer (insulating layer 502/503 in Figs. 5A-5E) and a second insulating layer (insulator layer 507 in Figs. 5C-5E) of the flexible electrode (trace layer 505 is between insulating layers 502/503 and layer 507 as seen in Figs. 5C-5E); and
an electrode site (electrode sites 103 in Fig. 1B; metal layer 511 in Fig. 5E; [0121]: metal layer 511 forms a pad; [0057]: the pad metal forms the electrode), located on an outer surface of at least one insulating layer of the first insulating layer or the second insulating layer (located on the outside of insulating layer 507 in Fig. 5E) and electrically coupled to the wire through a via hole (hole 509 as seen in Figs. 5D and 5E ) in the at least one insulating layer ([0120]-[0121]: the metal layer 511 contacts the trace layer 505 in Fig. 5E; a metal pad contacting a metal trace inherently forms an electrical coupling since both are touching and conductive; the pad contacts the trace through the hole 509 as seen in Figs. 5D and 5E),
wherein the surface electrode is configured to be flattened to fit against a biological tissue surface of the central nervous system after implantation ([0018]: the microelectrode array is deployed to form a planar surface configured to conform to a cortical surface; [0084]: deployed state is flat).
The traces of Hettick are approximately 5 microns wide and are made of titanium, platinum, gold, and the like ([0112], [0101]). This nearly identical to the instant application, which states the width of the wires is between 10nm to 500 micrometers and may be made of aurum (which is Latin for gold), platinum, tungsten, titanium alloy, etc. The instant application further states that the shapes, sizes, and the like of the wires are not limited and may be changed according to design requirements (instant application [0031]). Furthermore, Fig. 2 depicting the wire layer of the instant application and Figs. 1B and 1C of Hettick appear to show nearly identical structures. The applicant additionally states that the wires in the wire layer may be a film structure including a plurality of layers stacked in a thickness direction (instant application [0034]).
However, Hettick discloses a trace instead of a wire electrically connected to the electrodes, and wires and traces are typically recognized in the art as different types of electrical transmission means.
Cadwell teaches an electrode array and a system for deploying the electrode array ([Abstract]). As shown in Fig. 2C, the array has a plurality of electrodes which are connected to lead wires which are then bundled together. Each electrode contact of the array has an individual lead wire connected to it which, after being bundled into a pigtail, is connected to an electrical terminal of computing device ([0076]). The traces of Hettick serve the same function as both Cadwell and the instant application, and are approximately the same size and made of the same material as the instant application. Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to use wires instead of traces, since applicant has not disclosed that the wires solve any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with traces, as wires are known in the art as an equivalent alternative to traces as taught by Cadwell.
Regarding claim 2, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein the surface electrode is configured to be implanted to the biological tissue surface of the central nervous system using a support bracket (Hettick [0019]: the microelectrode array is delivered to the target region using a stent mesh – the stent mesh is the support bracket because it provides the support and expands the microelectrode array; the claim does not provide any structure for the support bracket and the stent mesh supports the array and delivers it, which is the same as the instant application; this claim is also a functional limitation because the support bracket is not positively recited as part of an assembly and the electrode array is capable of being delivered on any support that can connect through the holes 109 in Fig. 1B of Hettick).
Regarding claim 3, the Hettick/Cadwell combination discloses the surface electrode according to claim 2, wherein the support bracket has a micromechanical mechanism (Hettick [0064]: the stent-mesh may be a spring-like mechanism), comprising a cantilever beam (Hettick [0089]: the stent mesh may comprise hooks - hooks are a type of cantilever beam as they are attached at one end to the stent and extend outward), a latch, or a linkage mechanism (Hettick [0067], [0069]: the struts 205 are connected to adjacent struts by rings 207 – this forms a linkage mechanism because two pieces of the stent mesh are linked to each other; the instant application does not further specify this structure and two pieces which are connected together are a linkage).
Regarding claim 4, the Hettick/Cadwell combination discloses the surface electrode according to claim 2 as described above.
However, Hettick is silent to the support bracket being configured to implant the surface electrode by microfluidics.
Cadwell further teaches a system for deploying an electrode array ([Abstract]). Similar to Hettick, Cadwell teaches that the inserter, which serves the same function as the stent of Hettick, can comprise a spring mechanism or comprise a shape-memory material that expands once the cannula has retraced ([0082]). Utilizing a shape-memory material is the same expansion method as Hettick. Cadwell goes on to state that an alternative expansion method is utilizing a fluid-filled hydraulic system ([0082]). Furthermore, the instant application does not provide criticality to the microfluidic delivery means because it states “the mechanical structure of the support bracket for the implantation includes, but is not limited to, a cantilever, a latch, a linkage mechanism, microfluidics, etc.” ([0042]). Simply, the instant application states that microfluidics is one of many possible delivery methods, just like Cadwell. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the shape memory stent mesh of Hettick for the fluid hydraulic inserter of Cadwell because doing so is a simple substitution and it appears that the invention would perform equally as well with a shape memory material, as shape memory and fluid hydraulic systems are equivalent deployment means as taught by Cadwell.
Regarding claim 5, the Hettick/Cadwell combination discloses the surface electrode according to claim 2, wherein a material of the support bracket comprises any one or a combination of metal and alloy such as tungsten, platinum, titanium, and magnesium, a polymer material such as polyimide, polydimethylsiloxane (PDMS), hydrogel, epoxy, and polyethylene, and chitosan and polyethylene glycol (PEG) (Hettick [0064]: the stent-mesh may be composed of shape memory or superelastic nitinol (i.e., nickel-titanium), shape memory polymers, or other polymers such as polyether ether ketone (PEEK) and PEI; nitinol is a nickel-titanium alloy, thus the claim limitation of comprising an alloy of titanium is met).
Regarding claim 6, the Hettick/Cadwell combination discloses the surface electrode according to claim 2, wherein the support bracket is configured to implant the at least one electrode sheet into a craniotomy site with significant trauma (Hettick [Abstract]: the stent-mesh may be attached to the thin-film microelectrode array and configured to be advanced to a target area in a collapsed state and then expanded after reaching the target area to transition the thin-film microelectrode array to a deployed configuration; Hettick [0065]: the stent-mesh is configured with varying dimensions to cover a substantial amount or the entirety of the cortical surface area; this is a functional limitation and the stent mesh of Hettick is capable of delivered to any cortical surface on the brain since there is no structure claimed to provide for implantation into a craniotomy site with significant trauma), the part comprising a frontal lobe, occipital lobe, temporal lobe, or central cerebral great vessel (Hettick [0065]: the stent-mesh is configured with varying dimensions to cover a substantial amount or the entirety of the cortical surface area – covering the entirety of the cortical surface area would cover the frontal, occipital, and temporal lobes; Hettick [0048]: the neural interfaces may be used in target regions such as the temporal lobe on the cortical surface or deeper regions of the brain).
Regarding claim 7, the Hettick/Cadwell combination discloses the surface electrode according to claim 2, wherein the support bracket is configured to implant the at least one electrode sheet along a gap between a central nervous tissue and a bone (Hettick [0011]: the electrode array is delivered to the target site through a small burr hole; Hettick [0053]: the neural interface device includes electrode arrays configured for implantation at a target site of the brain; thus the electrodes are implanted by the stent mesh between the brain and skull since it is delivered via cannula through a burr hole and does not remove a portion of the skull; furthermore, this is a functional limitation and the array is capable of being implanted between nervous tissue and bone as the claim does not provide any specific structure for accomplishing this limitation).
Regarding claim 8, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein the surface electrode is configured to be in a flattened, rolled, or wrapped state during the implantation (Hettick [Claim 18]: the microelectrode assembly expands from a rolled-up state to a planar surface during delivery) and removed from a cerebrum in the flattened, rolled, or wrapped state (Hettick [0013]: retraction of the microelectrode array which allows for re-rolling upon retraction; these are also both functional limitations and the device can be delivered and removed in any desired shape since the device is flexible and there is no specific structure claimed to provide for the delivery and removal shape).
Regarding claim 9, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein the wire in each electrode sheet comprises a plurality of wires located in a wire layer of the flexible electrode and spaced apart from each other (there are a plurality of wires spaced apart from each other in the wire layer as seen in Fig. 1B of Hettick), and electrode sites in each electrode sheet comprises a plurality of electrode sites each electrically coupled with one of the plurality of wires through corresponding via holes in the second insulating layer (Hettick: multiple electrode sites 103 in Fig. 1B connected to the wires; the hole shown in Fig. 5E is for each electrode as that is the process of manufacturing the electrode array [0117]).
Regarding claim 10, the Hettick/Cadwell combination discloses the surface electrode according to claim 9, wherein the wire has a width of 10nm to 500µm (Hettick [0111]: the trace width is about 5 microns; in the combination, the trace sizes are maintained for the wires to maintain operability).
Regarding claim 11, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein a backend portion (Hettick: proximal end portions 128 and 415 shown in Figs. 1D and 4C and the entire proximal end portion shown in Fig. 8A) comprises at least one backend site (Hettick: backend electrodes 801 in Fig. 8A), wherein, the at least one electrode sheet each extends to the backend portion (Hettick: the electrode sheet extends to the backend portion as seen in Figs. 1D and 4C), and each backend site is electrically coupled to one of wires and a backend circuit through a via hole in the first insulating layer or the second insulating layer (Hettick [0096]: the microelectrode array is patterned by depositing a first insulation layer, patterning the traces, adding a second insulation layer, patterning the second insulation layer, and then adding the metal pads; Hettick [0112]: the proximal end is patterned in the same way with a first insulating layer, a trace layer, a second insulating layer, and a metal pad layer that is in an opening with a diameter of 10-230 microns; Hettick [0120]-[0121]: the patterning of the second insulating layer is shown to expose the trace to the metal pad by forming an opening; connecting a metal pad to a trace inherently forms an electrical connection), to implement bidirectional signal transmission between the electrode site electrically coupled to the one of the wires and the backend circuit (Hettick [0135]-[0137]: the proximal end connects to a PCB as shown in Figs. 8A-8D; Hettick [0013]: the neural interface device is configured to record from or stimulate a target region of the brain – thus there is bi-directional communication between the PCB, backend sites, and wires).
Regarding claim 12, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein a material of the first insulating layer and the second insulating layer is any one of polyimide, polydimethylsiloxane, parylene, epoxy, polyamide imide, polylactic acid, polylactic acid hydroxyacetic acid copolymer, SU-8 photoresist, silica gel, and silicone rubber, or a combination thereof (Hettick [0016]: the first and second insulating layers are polyimide).
Regarding claim 13, the Hettick/Cadwell combination discloses the surface electrode according to claim 11, wherein the first insulating layer and the second insulating layer have a thickness of 100nm to 300µm (Hettick [0095]: each of the polyimide layers have a thickness between about 9-12.5 microns).
Regarding claim 18, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein the surface electrode is configured to be customized according to a specific cerebrum shape modeled by three-dimensional reconstruction obtained by medical imaging means (MRI/CT) ([0018]: in the deployed state, the expansible stent forms a planar surface and wherein both the expansible stent and the microelectrode array are configured to conform to a cortical surface; [0051]: the neural interfaces may be deployed to assume the shape of curved surfaces of the brain including but not limited to the outer cortical surfaces, the inner ventricular surfaces, and the inner surfaces of blood vessels within the brain – this is a functional limitation, there is no specific structure disclosed to accomplish this, and the array of the Hettick/Cadwell combination can be made to conform to a variety of portions of the brain, thus it is capable of being made to a shape found by a CT or MRI).
Regarding claim 20, the Hettick/Cadwell combination discloses a method for manufacturing a surface electrode for a central nervous system, the surface electrode comprising the surface electrode according to claim 1 (surface electrode of claim 1 as described above), the method comprising:
manufacturing, layer by layer, the first insulating layer, a wire layer, the second insulating layer and an electrode site layer (Hettick [0096]: adding each layer in claimed order),
wherein, before manufacturing the electrode site layer, the via hole is manufactured at a position in the second insulating layer that corresponds to the electrode site by a patterning method (Hettick [0120]-[0121]: the opening 509 is created prior to depositing the pad layer).
Claim(s) 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over the Hettick/Cadwell combination as applied to claim 1, in further view of Gardner et al. (hereinafter ‘Gardner’, US 20220361323 A1).
Regarding claim 14, the Hettick/Cadwell combination discloses the surface electrode according to claim 1, wherein the electrode site and the wire in each electrode sheet comprise a conductive layer (Hettick: the electrode site contains a conductive metal 511 in Fig. 5E ).
Furthermore, as explained in the 112b rejection above, the structure of the wire is unclear. Wires are, by definition, metal drawn into a thread or rod. Claim 14 claims the wire comprises an adhesive layer, which is inconsistent with the definition of a wire. Additionally, paragraph [0034] of the instant application states that the wires are a film structure including a plurality of layers. This is also not consistent with the definition of a wire, but is instead consistent with the definition of a trace. The independent claim claims a wire, which Cadwell was combined with Hettick to introduce the wire. Because of the inconsistencies, it appears claim 14 is instead claiming a trace configuration but still calling it a wire. Hettick discloses a trace for connecting to the electrodes (electrical traces 101 in Fig. 1B and 505 in Figs. 5B-5E). It would be obvious to one of ordinary skill in the art before the effective filing date to substitute the wires of the Hettick/Cadwell combination for the traces of Hettick because it appears the applicant is claiming the structure of traces instead of wires and the applicant has not provided criticality to the wires/traces claimed and the substitution will lead to the expected outcome of maintaining an electrical connection between the electrodes and the processing circuitry.
Hettick further states that the pad and trace metals of the microelectrode array with embedded active circuits may include titanium, platinum, and gold for adhesion or conduction properties ([0147]). Hettick further states that the trace patterning can be performed through photolithography or physical vapor deposition ([0102]).
However, Hettick is silent to the trace layer comprising an adhesive layer.
Gardner teaches a method for fabricating multielectrode arrays comprising a flexible substrate, photopatterned electrical traces spaced apart and insulated from one another, and a plurality of printed electrodes ([Abstract]). Gardner further shows that such electrode arrays can be configured to be placed on the brain, just like the Hettick/Cadwell combination. Gardner further states that the traces can be deposited onto the base substrate using photolithography, which is the same method as Hettick ([0174]). Alternatively, Gardner states that the traces can be photopatterned as three sequential layers of titanium, platinum, and titanium ([0174]). The photopatterning of the traces can include the three-step sputter process where Titanium is used as an adhesion layer for the Platinum to the substrate ([0174]). Gardner clearly discloses that the traces can be created through photolithography or through a three-step photopatterning process that deposits platinum on a titanium adhesive layer. Therefore, it would have been obvious to one of ordinary skill in the art that applying the known technique of photopatterning three layers as taught by Collins to the array of the Hettick/Cadwell combination would have yielded predictable results and resulted in a functioning trace for the electrode array since Gardner teaches that both processes form equivalent structures, thus resulting in the claimed invention where the trace/wire layer comprises an adhesive layer and a conductive layer.
Regarding claim 15, the Hettick/Cadwell/Gardner combination discloses the surface electrode according to claim 14, wherein
a material of the conductive layer is any one gold, platinum, iridium, tungsten, magnesium, molybdenum, platinum-iridium alloy, titanium alloy, graphite, and carbon nanotube or a combination thereof (Hettick [0106]: the second metal layer is made of titanium, platinum, or gold), and the conductive layer has a thickness of 5nm to 2µm ([0106]: the second metal layer may have a depth of about 20-500nm), and
a material of the adhesion layer comprises titanium (Ti), titanium nitride (TiN), chromium (Cr), tantalum (Ta), tantalum nitride (TaN) (Gardner [0174]: titanium is used as the adhesion layer), and the adhesion layer has a thickness of 1 to 50nm (Gardner [0174]: the titanium layer is about 10nm thick).
Regarding claim 16, the Hettick/Cadwell/Gardner combination discloses the surface electrode according to claim 15, wherein when the material of the conductive layer is metal (Hettick [[0106]: the second metal layer is made of titanium, platinum, or gold – these are all metals), the conductive layer further comprises a surface treatment layer (Hettick [0096]: an electrode layer may be made on top of the metal pad layer – “surface treatment layer” has no specific claimed structure and is thus interpreted as a surface layer added to the conductive pad – adding a layer is a form of treatment), a material of the surface treatment layer being any one of or a combination of PEDOT, iridium dioxide, porous gold, and platinum black (Pt black) ([Hettick [0107]: The electrode layer may be composed of at least one of titanium and its compounds, platinum, gold, iridium and its compounds, ruthenium and its compounds; Hettick [0057]: electrodes may also be composed of organic conductive materials such as poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS) and/or inorganic conductive materials such as platinum, iridium and its compounds, ruthenium and its compounds, titanium nitride, and additional materials as would be apparent to a person having an ordinary level of skill in the art).
Claim(s) 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over the Hettick/Cadwell combination as applied to claims 1 and 20, respectively, in further view of Xie et al. (hereinafter ‘Xie’, US 20200261025 A1).
Regarding claim 17, the Hettick/Cadwell combination discloses the surface electrode according to claim 1 as described above. Hettick further discloses that the thin-film electrode array is manufactured on a treated substrate.
However, the Hettick/Cadwell is silent to how the substrate is separated from the first polyimide layer.
Xie teaches a neural probe comprising an electrode array and a method of fabricating the neural probe ([0008]-[0010]). The method includes depositing a sacrificial layer formed of nickel onto a silicon substrate, patterning an insulative layer on the sacrificial layer, patterning nanoscale wires on the insulative layer, adding a second insulative layer, patterning the second insulative layer to expose the wires, and finally patterning electrodes on the on the second insulative layer and the exposed nanoscale wires ([0068]). Aside from the inclusion of the sacrificial layer, the fabrication method is nearly identical to that of Hettick. The sacrificial layer, composed of nickel and is 100nm thick, is removed via an etchant to release the rigid base substrate from the flexible electrode array ([0068]-[0069]). A thin, nickel sacrificial layer would inherently have a degree of flexibility, as well. Additionally, the inclusion of a sacrificial layer in the device of the Hettick/Cadwell combination would be within the level of ordinary skill in the art and simply provide the expected result of providing a means to separate the base substrate from the flexible electrode array. 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 thin, nickel sacrificial layer of Xie with the device of the Hettick/Cadwell combination in order to provide a means to separate the flexible electrode array from the base substrate once manufacturing is completed, thus arriving in the claimed flexible, nickel layer that is configured to be removed by a specific substance.
Regarding claim 21, the Hettick/Cadwell combination discloses the method for manufacturing according to claim 20 as described above.
However, the Hettick/Cadwell combination is silent to manufacturing a flexible separation layer on a substrate; manufacturing the first insulating layer, the wire layer, the second insulating layer and the electrode site layer on the flexible separation layer; and removing the flexible separation layer to separate the flexible electrode from the substrate.
Xie teaches a neural probe comprising an electrode array and a method of fabricating the neural probe ([0008]-[0010]). The method includes depositing a sacrificial layer formed of nickel onto a silicon substrate, patterning an insulative layer on the sacrificial layer, patterning nanoscale wires on the insulative layer, adding a second insulative layer, patterning the second insulative layer to expose the wires, and finally patterning electrodes on the on the second insulative layer and the exposed nanoscale wires ([0068]). Aside from the inclusion of the sacrificial layer, the fabrication method is nearly identical to that of Hettick. The sacrificial layer, composed of nickel and is 100nm thick, is removed via an etchant to release the rigid base substrate from the flexible electrode array ([0068]-[0069]). A thin, nickel sacrificial layer would inherently have a degree of flexibility, as well. Additionally, the inclusion of a sacrificial layer in the device of the Hettick/Cadwell combination would be within the level of ordinary skill in the art and simply provide the expected result of providing a means to separate the base substrate from the flexible electrode array. 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 thin, nickel sacrificial layer of Xie with the device of the Hettick/Cadwell combination in order to provide a means to separate the flexible electrode array from the base substrate once manufacturing is completed, thus arriving at the claimed method since the method of the Hettick/Cadwell combination will be performed on the sacrificial layer instead of directly on the substrate layer.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over the Hettick/Cadwell combination as applied to claim 1, in further view of Bonmassar et al. (hereinafter ‘Bonmassar’, US 20150099959 A1).
Regarding claim 19, the Hettick/Cadwell combination discloses the surface electrode according to claim 1 as described above. Hettick further discloses that the traces and electrodes are made of titanium, platinum, or gold ([0107], [0101]). Hettick further discloses that the array is 19 micrometers thick ([0095]: 2 insulating layer 9 micrometers thick and 2 metal layers 500nm thick, totaling 19 micrometers). The insulating layers of the instant application alone can be up to 300 micrometers thick (instant application [0032]). The instant application further states that the MRI and CT compatibility is due to the use of non-magnetic metals and ultra-thin design (instant application [0026]). Therefore, the electrode array of the Hettick/Cadwell combination is capable of being CT compatible because the device of the Hettick/Cadwell combination is thinner than the device of the instant application, and the use of non-magnetic metals makes it MRI compatible.
While it is the opinion of the examiner that the electrode array of the Hettick/Cadwell combination is capable of being CT and MRI compatible, Hettick does not explicitly state this fact.
Bonmassar teaches an electrode array configured for implantation into a subject ([Abstract]). Bonmassar states that the conductive ink that forms the traces can be gold, tantalum, tungsten, titanium, cobalt-chromium, platinum, etc. ([0028]). Similarly, the electrode include gold, platinum, and the like ([0027]). The materials that form the traces, and similarly the electrodes since they are the same or similar materials, are MRI-compatible ([Abstract]). The metal particles of the Hettick/Cadwell combination are similarly non-ferromagnetic as they are the same materials. Bonmassar further teaches that utilizing an electrode array compatible with a variety of imaging systems allows for procedures such as simultaneous subdural electrocortical recording/stimulation and fMRI to be performed without an increased risk to the patient. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to ensure that the device of the Hettick/Cadwell utilizes MRI and CT compatible materials as taught by Bonmassar in order to reduce the risk to the patient during procedures that rely on various imaging techniques.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the Hettick/Cadwell combination as applied to claim 20, in further view of Tandon et al. (hereinafter ‘Tandon’, US 20190175020 A1).
Regarding claim 22, the Hettick/Cadwell combination discloses the method for manufacturing according to claim 20 as described above. Hettick further states that the electrode array is manufactured to conform to various brain surfaces ([0051]).
However, the Hettick/Cadwell combination is silent to a shape, size, and site distribution of the surface electrode being determined according to a specific cerebrum modeled by three-dimensional reconstruction obtained by medical imaging means (MRI/CT).
Tandon teaches a method for generating a 3D model of a patient’s cortical surface to generate a customized electrode array ([0024]). The 3D cortical model may be utilized to guide the location and orientation of an electrode array to optimize the array for the desired recording regions over areas of interest and to conform to the particular anatomical features and needs for a patient ([0024]). The 3D cortical model may be generated through the use of an MRI study and/or any other appropriate imaging method ([0014]). A patient’s specific 3D model is used to design the customized electrode array ([0072]). With the patient’s 3D model as a guide, rapid manufacturing is used to produce the customized electrode array such that the electrodes of the electrode array are placed in desired areas and/or not placed in anatomically ambiguous locations, such as between gyri or lobes ([0072]). Modifying the size, shape, and electrode distribution are all obvious design choices in order to customize an electrode array because those are the three physical characteristics that would have an impact on whether the array conforms to the patient and ensures the electrodes are placed in the correct spots as taught by Tandon. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a 3D model of a patient’s brain in order to customize the size, shape, and site distribution of the electrode array of the Hettick/Cadwell combination in order to ensure the array is optimized for recording desired signals and conforming to the cortical surface of the specific patient being measured.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794