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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US Patent No 20150305643) in view of Zhao (Journal of Micromechanics and Microengineering article).
Regarding claim 1, Negi teaches a microelectrode probe device (electrode grid device 300, [0051]), comprising: multiple layers of biocompatible polymer films (see from figs 4A-4D in which substrate and parylene layers form the electrode device) formed in an elongate shape (see fig 3A showing the device in an elongate shape); micro-electrode recording conductive sites and macro-electrode conductive stimulation sites exposed from the polymer films near a first terminal end of the elongate shape (see from fig 3A as well as [0051] in which there are a variety of micro-electrode sites and macro-electrode sites referenced as 1-16 and A-G respectively, in which they are found on the polymer films near a first end of the elongate shape); insulated electrical traces within the polymer films connected to the micro-electrode recording conductive sites and macro-electrode conductive stimulation sites (see from [0052]-[0053] in which metal traces are found within the micro-cable 310 that connects all of the micro and macro electrode channels).
Negi does not teach an elongate hollow within the multiple layers of polymer films extending to micro-electrode recording conductive sites and macro-electrode conductive stimulation sites, the elongated hollow being configured to accommodate a removable stainless-steel stylet.
However, the analogous research article of Zhao which discloses an analogous poly-film microelectrode probe does disclose an elongate hollow within the multiple layers of polymer films extending to micro-electrode recording conductive sites and macro-electrode conductive stimulation sites, the elongated hollow being configured to accommodate a removable stainless-steel stylet (see from the article introduction, seen on page 1, as well as the figure 1, which show that microelectrode probes may have a shank shaft found within the multiple layers of poly-film, seen as the analogous elongate hollow, in which a stainless steel tube or shank may be inserted within the probe shaft during insertion, seen as the analogous removable stainless steel stylet).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the microelectrode probe device taught by Negi, with that of the elongate hollow and stainless steel stylet insert taught by Zhao, in order to increase the mechanical strength of the microelectrode probe device during insertion so that the electrode device does not buckle or break while in use, as taught by Zhao, [Page 1].
Regarding claim 2, the combination teaches the microelectrode probe device of claim 1, comprising at least one removable stainless-steel stylet in the elongated hollow (see Zhao, from the article introduction, seen on page 1, as well as the figure 1, which show that microelectrode probes may have a shank shaft found within the multiple layers of poly-film, seen as the analogous elongate hollow, in which a stainless steel tube or shank may be inserted within the probe shaft during insertion, seen as the analogous removable stainless steel stylet).
Regarding claim 3, the combination teaches the microelectrode probe device of claim 2, wherein the at least one removable stainless-steel stylet is at least -30 nm long (see Zhao, from the article introduction, seen on page 1, as well as the figure 1, in which the stainless steel shaft may be fabricated over 10.5mm long, thereby surpassing at least 30nm as claimed).
Regarding claim 4, the combination teaches the microelectrode probe device of claim 3, wherein the at least one removable stainless-steel stylet is at least -90 nm long (see Zhao, from the article introduction, seen on page 1, as well as the figure 1, in which the stainless steel shaft may be fabricated over 10.5mm long, thereby surpassing at least 90nm as claimed).
Regarding claim 5, Negi teaches the microelectrode probe device of claim 3, comprising 64 or more of the micro-electrode recording conductive sites connected to individual corresponding ones of the insulated electrical traces (see from [0030]-[0031] in which the electrode grid device may include 128 different channels or sites used for measuring signal data, connected via the electrical traces).
Regarding claim 6, Negi teaches the microelectrode probe device of claim 3, comprising 128 or more of the micro-electrode recording conductive sites connected to individual corresponding ones of the insulated electrical traces (see from [0030]-[0031] in which the electrode grid device may include 128 different channels or sites used for measuring signal data, connected via the electrical traces).
Regarding claim 7, the combination teaches the microelectrode probe device of claim 2, wherein at least a portion of the multiple layers of polymer films including the micro-electrode recording conductive sites and macro-electrode conductive stimulation sites is wrapped around the removable stainless-steel stylet in a configuration for implantation (see from Zhao, the article introduction, seen on page 1, as well as the figure 1, which show that microelectrode probes may have a shank shaft found within the multiple layers of poly-film, seen as the analogous elongate hollow, in which a stainless steel tube or shank may be inserted within the probe shaft during insertion, seen as the analogous removable stainless steel stylet, and it is used as a delivery mechanism which carry the thin microelectrodes which are wrapped around it during use).
Regarding claim 8, Negi teaches the microelectrode probe device of claim 2, comprising via connections between layers and multiple traces in different layers connected to the micro-electrode recording conductive sites and macro-electrode conductive stimulation sites (see [0057] and also fig 5C which show the via connections 506 which connect the micro and macro electrode sites on the electrode grid to each other and connects with the integrated PCB device).
Regarding claims 9 and 10, Negi teaches the microelectrode probe device of claim 2, comprising bonding pads at an opposite end of the micro-electrode recording conductive sites (see in which the electrode grid array contains bond pads which are connected via the traces to interface with a PCB 502 opposite the recording sites, [0057]).
Regarding claim 11, Negi teaches the microelectrode probe device of claim 10, wherein the elongate shape is a T shape, and the opposite end comprises a wide top end of the T shape (see from fig 3A in which the elongate is in a T-shape configuration).
Regarding claim 12, the combination teaches the microelectrode probe device of claim 10, wherein the elongate shape is a U shape with a narrow elongate leg and a wider elongate leg, and the opposite end comprises the wider elongate leg (see from Zhao fig 1, which indicated a U shape elongate with a narrow leg being the steel shaft/stylet and the wider leg containing the trace components).
Regarding claim 13, the combination teaches the microelectrode probe device of claim 10, wherein the elongate hollow is in the narrow elongate leg (see from Zhao fig 1, which indicated a U shape elongate with a narrow leg being the steel shaft/stylet and the wider leg containing the trace components).
Regarding claim 14, the combination teaches the microelectrode probe device of claim 1, wherein the stylet comprises a diameter of 0.01 - 0.025 mm (see Zhao, from the article materials and methods, seen on page 2, as well as the figure 1, in which the stainless steel shaft may be fabricated to have a width of 10um, falling within the claimed range).
Regarding claim 15, Negi teaches the microelectrode probe device of claim 1, wherein the biocompatible polymer layers comprise Parylene or polyimide (see from figs 4A-4D in which substrate and parylene layers form the electrode device).
Regarding claim 16, Negi teaches the microelectrode probe device of claim 1, wherein the biocompatible polymer layers comprise a total thickness of 10 to 15um (see in which the parylene layers of the electrode grid may be between 5 to 15um, [0054], encapsulating the claimed range).
Regarding claim 17, Negi teaches the microelectrode probe device of claim 1, wherein the insulated electrical traces comprise multi-metallization layers (see in which Negi describes that the traces may be metallic conductive material such as gold metal traces, therefore being multi-metallization, [0052]).
Regarding claim 18, Negi teaches the microelectrode probe device of claim 1, wherein multi- metallization layers comprise Cr/Pt (see in which Negi describes that the interconnecting layers between polymer film, also equated to the channel traces may be platinum based material, [0053]).
Regarding claim 19, Negi teaches the microelectrode probe device of claim 1, wherein multi- metallization layers comprise Cr/Au (see in which Negi describes that the traces may be metallic conductive material such as gold metal traces, [0052]).
Conclusion
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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