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 .
Response to Amendment
The amendment filed 25 March 2026 has been entered. Claims 1, 14-15, and 22 are currently amended. Claim 4 is canceled, and claims 28-42 are new. Claims 1-3, 5, 14-15, and 21-42 are pending in the application.
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 1-3, 5, 14-15, and 21-42 are rejected under 35 U.S.C. 103 as being unpatentable over Dayeh et al. (WO 2017/127551), hereinafter Dayeh, in view of Ashe et al. (US PGPub No. 2018/0160929), hereinafter Ashe, and Tang et al. (US PGPub No. 2014/0161973), hereinafter Tang, and further Lehmann et al. (US PGPub No. 2015/0005573), hereinafter Lehmann.
Regarding claims 1 and 28-30, Dayeh teaches an intermediate structure comprising:
a substrate (Figs. 2A-3B: insulating substrate 100);
a conductive block extending from the substrate (semiconductor block 200), wherein the conductive block comprises a conductive material (par. 0041: “The probes 103 are a semiconductor material, e.g. silicon”), wherein the conductive block is used to form an array of microwires extending from the substrate (Fig. 3B: array of probes 103 extending from substrate 100; par. 0041: “the semiconductor probes 100 have a diameter of ~ 10 nm - 200 nm; ” examiner interprets probes with a diameter of 0.01 µm to 0.2 µm to be microwires, as broadly as claimed) by applying one or more subtractive processes to the conductive block (Figs. 2-3; par. 0044: “The vertical nanowire probes 103 are fabricated by a masked dry etching process”); and
a plurality of interconnects comprising another conductive material (Figs. 2A-2B: conductive metal layers 204, 206, 208), wherein the conductive block is connected or bonded to the substrate via an interconnect of the plurality of interconnects (Fig. 2B and par. 0042: “The semiconductor layer thin layer 200 is then brought into contact with the metal layer 208, and the wafer bonding is then performed”), and wherein the conductive material of the plurality of interconnects comprises a bonding material comprising three metallic layers for respectively facilitating interfacial adhesion, generating a diffusion bonding barrier, and facilitating diffusion bonding and conductivity between the conductive block and the substrate (par. 0042: “the multi-layer metal pattern includes the different metal layers, 204, 206 and 208 that serve different functions […] The base metal layer 204 promotes adhesion with the substrate 100, and has sufficient thickness to reduce the overall resistance of metal leads and interconnects. The center layer 206 is a diffusion blocking layer that allows only the solid-state reaction between the semiconductor 200 and the top metal layer 208 without allowing an alloy forming reaction with the blocking layer 206 or the base layer 204”);
wherein the intermediate structure is used to form an implantable device (par. 0026: “a neural probe sensor array”) comprising (a) the substrate, (b) the array of microwires, and (c) the plurality of interconnects connecting the array of wires to the substrate (Figs. 1A, 3B).
Dayeh teaches wherein each wire is connected to a conductor in the substrate for connecting with electronic components (Figs. 1B-1C: metal leads 110 and peripheral metal pads 112; par. 0041: “Probes 103 are electrically conducted through individual and electrically isolated ones of the metal contacts 108, corresponding metal leads 110, and corresponding peripheral metal pads 112 (not shown in FIG. 1B, which is a partial view for clarity) for connection to a measurement circuit”) but does not explicitly teach wherein the conductors are feedthroughs, and wherein a feedthrough of the plurality of feedthroughs has a diameter of between about 50 µm and about 150 µm. However, in related neural probe art, Ashe teaches a microelectrode array substrate comprising a plurality of feedthroughs (Fig. 3: via structures 102) having a diameter of between about 50 µm and about 150 µm (Fig. 7: probes 122 having the same diameter as vias 102; par. 0048: “neural probe arrays with versatile shaft geometries (e.g., diameters ranging from 5 μm-130 μm), wherein the plurality of feedthroughs comprises a conductive material (par. 0040: “a plurality of spaced apart conductive (e.g., metal) vias 102 that pass through the interposer 100 to provide electrically conductive pathways from one surface of the interposer 100 to an opposing surface”), which allows electronics to be connected to the array using flip chip bonding on the opposite side of the substrate (Figs. 5-6 and par. 0046). 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 substrate of Dayeh by replacing the metal leads and peripheral metal pads with via structures, as taught by Ashe, so that electronics can be connected to the array of wires using flip chip bonding on the opposite side of the substrate, as taught by Ashe.
Dayeh further is silent with regard to hermeticity and does not explicitly teach wherein the substrate and the plurality of feedthroughs form a hermetically sealed unit. However, in an analogous art, Tang teaches a hermetic substrate and feedthrough subassembly for implantable medical devices comprising a platinum feedthrough in an alumina substrate (par. 0022: “A hermetic seal exists between the platinum fill and the alumina dielectric substrate, wherein the hermetic seal minimizes damaging tensile stresses and, optimally, may comprise a mutually conformal interface (or tortuous, intimate knitline) between the alumina dielectric substrate and the platinum fill”), which Tang teaches is necessary for isolating the device’s electronics from the ingress of body fluids (par. 0004: “the hermetic terminal isolates the internal circuitry, connections, power sources and other components in the device from ingress of body fluids. Ingress of body fluids into an implantable medical device is known to be a contributing factor to device malfunction and may contribute to the compromise or failure of electrical circuitry, connections, power sources and other components within an implantable medical device”) and provides a structure that is not susceptible to erosion by body fluids and can tolerate stress levels without losing hermeticity (par. 0015). 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 intermediate structure of Dayeh and Ashe by forming a hermetically sealed unit with the substrate and feedthroughs, as taught by Tang, in order to isolate the implantable device’s electronics from body fluids and provide a structure that is not susceptible to erosion by body fluids and can tolerate stress levels without losing hermeticity, as taught by Tang.
Dayeh further teaches wherein the conductive block comprises a conductive material that is different from the conductive material comprised by the plurality of interconnects (Fig. 2B; par. 0045: “Si constitutes the main body of the sensor […], Ni is used for silicidation bonding and as a current conduction layer, and Ti is used as a Ni diffusion barrier and adhesion layer”), but because Dayeh does not disclose feedthroughs in the substrate, Dayeh does not explicitly teach wherein the conductive material of the conductive block is different from the conductive material of the plurality of feedthroughs. However, Dayeh also teaches wherein the various conductor elements bonded to each wire in the array can be made of different metals (par. 0041: “metal connections, 108, 110 and 112, can be made of the same metal or different metals”), and Tang further teaches wherein the feedthroughs comprise platinum (par. 0010: “hermetic feedthrough comprising a monolithic alumina insulator substrate within which a platinum conductive pathway or via resides”). In light of Dayeh’s teaching that conductors can be made of different metals, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to choose platinum as the conductive material for the feedthroughs of the combined reference, as taught by Tang, since one of ordinary skill in the art could have performed such a substitution with the predictable result that a conductive path would be established from the Si probe through the interconnect and further through the platinum feedthrough to the opposing side of the substrate.
The combination does not explicitly teach wherein the bonding material is a biocompatible solder material and comprises a titanium layer configured to facilitate interfacial adhesion between the conductive block and the feedthrough, a platinum layer configured to generate a diffusion bonding barrier between the conductive block and the feedthrough so that homogenous diffusion bonding occurs at the platinum layer, and a gold layer configured to facilitate diffusion bonding and conductivity between the conductive block and the feedthrough. However, these metallic materials are well-known in the art for providing desired functional properties in biocompatible solder of implantable devices. For instance, Lehmann teaches platinum as a diffusion stop barrier between an titanium layer providing adhesion and a gold layer providing solderability (par. 0114: “These metallization layers can be made up of titanium as an adhesion layer to the sapphire substrate 332, thus forming a hermetic interface between the two components. Platinum can be applied to provide a diffusion stop layer for later AuSn reflow soldering;” examiner notes that the disclosed metal materials are all biocompatible). Accordingly, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the solder material of the combined reference in the layered structure of titanium, platinum, and gold as taught by Lehmann, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 2, the combination teaches the intermediate structure of claim 1 as described previously. Tang further teaches wherein the substrate comprises ceramic (par. 0010: “hermetic feedthrough comprising a monolithic alumina insulator substrate within which a platinum conductive pathway or via resides”).
Regarding claims 3, 14, 22, and 31-42, the combination teaches the intermediate product of claim 1 as described previously. Based on the extremely wide range of thicknesses and widths both disclosed in the Applicant’s specification (e.g. see pars. 151, 192, 194, 272) and recited in the claims for the substrate, the feedthroughs, the conductive block, and the solder material, criticality has not been established for any of the recited thicknesses or widths. It therefore would have been an obvious matter of design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the substrate, feedthroughs, conductive block, and solder material at any thickness or width within the claimed ranges, because Applicant has not disclosed that any of the claimed thicknesses or widths provide an advantage, are used for a particular purpose, or solve a stated problem, and it appears the invention would perform equally as well with any of the recited dimensions as with the dimensions taught by the prior art. Furthermore, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 5, the combination teaches the intermediate structure of claim 1 as described previously. Ashe further teaches wherein the plurality of feedthroughs is completely filled with the first conductive material (Fig. 3 and par. 0040: “gold-filled vias 102”).
Regarding claim 15, the combination teaches the intermediate structure of claim 14 as described previously. Dayeh further teaches wherein the biocompatible solder material is configured to connect the array of microwires to the plurality of feedthroughs without causing electrical shorting between adjacent feedthroughs (Figs. 1A-2B; par. 0041: “Probes 103 are electrically conducted through individual and electrically isolated ones of the metal contacts 108, corresponding metal leads 110, and corresponding peripheral metal pads 112;” examiner interprets electrically isolated metal contacts and corresponding conductors as the biocompatible solder material configured to connect the array of wires to the plurality of feedthroughs without causing electrical shorting between adjacent feedthroughs).
Regarding claim 21, the combination teaches the intermediate structure of claim 1 as described previously. Dayeh further teaches wherein the array of microwires is configured to be inserted into brain tissue (par. 0011: “the invention is a neural probe sensor array”).
Regarding claim 23, the combination teaches the intermediate structure of claim 1 as described previously. Dayeh further teaches wherein the interconnect of the plurality of interconnects comprises a diffusion bond (Fig. 2B and par. 0042: “This wafer bonding process takes advantage of the solid-state reaction between semiconductor layer 200 and the topmost metal layer 208, forming a stable metal-semiconductor alloy (as the interface 102) that will provide enough mechanical strength for the bonding”).
Regarding claims 24-25, the combination teaches the intermediate structure of claim 1 as described previously. The limitations in claims 24 and 25 are directed to various types of subtractive processes that may be applied to the intermediate structure recited in claim 1, which appear to produce the same result as the subtractive process disclosed by Dayeh. As such, claims 24 and 25 are rejected for the same reasons laid out previously in the rejection of claim 1, because even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 26, the combination teaches the intermediate structure of claim 1 as described previously. Dayeh further teaches wherein the one or more subtractive processes are configured to remove one or more portions of the conductive block without affecting the substrate and the conductors thereon (par. 0030: “the semiconductor electrode arrays are formed via a dry etching process and perfectly aligned to predetermined portions of the metal leads on the substrate, e.g., on predetermined end portions of one or more lead lines. Generally, preferred methods are substrate independent for substrates that tolerate temperatures in the range of ~300-400°C” and par. 0031: “Fabrication methods of the invention are CMOS compatible”), which examiner interprets as configured to remove one or more portions of the conductive block without affecting the plurality of feedthroughs in the substrate, as taught by the combined reference.
Regarding claim 27, the combination teaches the intermediate device of claim 1 as described previously. Dayeh further teaches wherein the conductive block comprises (i) a proximal end located adjacent to the plurality of interconnects, and (ii) a distal end, wherein the distal end of the conductive block comprises one or more sharpened tips (Fig. 3A: proximal end of conductive block 200 bonded to interconnect 208, distal end comprising metal tips 302).
Response to Arguments
Applicant’s arguments, filed 25 March 2026, with respect to the rejection(s) of claim 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lehmann. As previously described, Lehmann demonstrates that it is known in the art to use titanium layers for adhesion, platinum layers for diffusion blocking, and gold layers for bonding and solderability.
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794
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