DETAILED ACTION
This action is pursuant to claims filed on 2/23/2026. Claims 1-10, 18-19, 21-27, 34, and 40 are pending. A final action on the merits of claims 1-10, 18-19, 21-27 34, and 40 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 .
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:
Claim(s) 1-2, 4-5, 7-10, 18-19, 21-24, 26, 27, 34, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Negi et al. (hereinafter ‘Negi’, US 2015/0305643 A1) in view of Kipke et al. (hereinafter ‘Kipke’, US 9248269 B2) and in further view of Shah et al. (US 20220175320 A1).
Regarding independent claim 1, Negi discloses an electroencephalography (EEG) device ([0003]-[0007]: the invention is a system for detecting and processing neural activity through ECoG or iEEG, which is known in the art to be a type of EEG) comprising:
an electrode array (electrode grid 350 in Fig. 3B) comprising a plurality of microelectrodes (microelectrodes 370 in Fig. 3B) and macroelectrodes (macroelectrodes 380 in Fig. 3B) uniformly or non-uniformly arranged (microelectrodes and macroelectrodes are uniformly arranged as seen in Fig. 3B) in a polymer-based substrate ([0032]: the electrode grid can be formed on a bi-layer substrate including an outer ion barrier and an inner adjacent moisture barrier. For example, the outer ion barrier can be a polymer such as parylene-C, polyimide, or the like); and
a signal acquisition component (signal processing component 120 in Fig. 1A) coupled to the electrode array ([0033]: the processing unit is connected to the electrode array as seen in Fig. 1A and 1B) configured to collect and transmit electrical signals obtained from a subject's brain ([0033]: the signal processing unit 120 is configured to collect and multiplex the digital neural activity information prior to transmission of the digital neural activity information; [0046]: the processing unit can transmit the digital neural activity to an external signal processing device).
wherein the signal acquisition component comprises at least one lead (cable 130 in Fig. 1C) comprising a plurality of traces ([0034]: cable 130 is a micro-ribbon cable that is constructed; [0052]: the micro-ribbon cable includes conductive traces; cable 130 and cable 310 correspond to the same micro-ribbon cable for connecting the electrodes to the processing component); wherein the at least one lead is comprises traces consisting of gold ([0052]: the conductive traces are gold).
Negi further discloses that the macroelectrodes and the microelectrodes emanate from the ribbon cable as seen in Fig. 3B ([0053]).
While it is the examiner’s position that the traces of the ribbon-cable connect to contact points on the electrodes to facilitate signal transmission is inherent, Negi does not outright disclose the microwires extending from contact points on the electrodes.
Kipke teaches an electrode array used for ECoG measurement (Col 1, lines 20-38). Kipke further teaches that device can include individual traces that can be gathered to form helically coiled groups, which are leads of microwires (Col 5, lines 64-67 – Col 6, lines 1-12). The traces connect the electrodes to the electronic subsystem 440, performing the same function as the cable from Negi (Col 3, lines 58-67 – Col 4, lines 1-10). The traces are used to connect to the electrodes such that the signals are transferred from the electrodes through the traces to the electronic subsystem which can send them on for further processing (Col 3, lines 58-67 – Col 4, lines 1-10). Ensuring the microwires/traces contact the electrodes is an obvious combination in order to facilitate signal transmission between the electrodes and the processing device. 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 microwire connection of Kipke with the device of Negi such that the traces connect to the electrodes to facilitate signal transmission between the electrodes and the processing device.
However, the Negi/Kipke combination is silent to the size of the traces.
Negi describes in paragraph [0055] that the electrode array is composed of a first parylene layer 404 that is 5µm thick and a second layer that is 15µm with the gold layer sandwiched between as seen in Fig. 4D. According to figure 4D, the gold, which the traces are composed of, appears to be approximately the same size as the layer 404. While this is focused on the electrode grid itself and does not specifically state the size of the traces, it indicates that Negi teaches a conductive gold layer close to the claimed size.
Shah teaches a thin-film lead assembly and neural interface that includes one or more conductive traces in electrical connection with electrodes ([Abstract]). The conductive traces can be made of pure gold and can have a thickness from about 0.5µm to about 10 µm ([0070]-[0071]). Shah goes on to further state that the thickness of the conductive traces is dependent on the particular impedance desired for the conductor in order to ensure excellent signal integrity ([0071]). Shah further teaches that the thin-film neural interface is improved over the standard devices because it is smaller and has greater flexibility ([0060]). If the overall device has enhanced flexibility, the gold traces contribute to that. Utilizing the size of the conductive traces of Shah for the traces of the Negi/Kipke combination would be of routine skill in the art as Negi contemplates the use of gold at a similar size. Furthermore, it would have been an obvious matter of design choice to set the thickness of the traces to about 5 micrometers, since such a modification would have involved a mere change in the size of a component and the applicant has not assigned criticality to the size of 5 micrometers simply through the use of “about” which indicates a degree of variability. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gold traces to be 5µm thick because Shah teaches modifying the trace thickness within a range that includes the claimed thickness to modify the desired resistance value and doing so is merely a change in the size of the traces which is well within an ordinary level of skill in the art.
Regarding claim 2, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the electrode array is configured to perform electrocorticography (ECOG) on the subject ([0029]: the electrode grid can be an ECoG array system).
Regarding claim 4, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein at least a portion of the electrode array or the signal acquisition component comprise silicone molding ([0039]: the signal processing unit 120 can be coated with silicone).
Regarding claim 5, the Negi/Kipke/Shah combination discloses the device according to claim 1.
However, Negi is silent to the electrode array comprising a coating of silicone having a thickness from 0.2mm to 2.0mm.
Kipke further teaches that the electrode array has a 1mm thick silicone backing (Col 3, lines 1-5). The silicone backing imparts a flexibility to the array (Col 2, lines 7-32). 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 electrode array substrate of Negi with the silicone backing of Kipke to impart a greater degree of flexibility to the array substrate.
Regarding claim 7, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the device further comprises a circuit ([0033]: the processing unit can include computer circuitry) coupled to the electrode array (processing unit 120 is coupled to electrode array 110 as seen in Fig. 1B) and configured to amplify and/or digitize the electrical signals ([0033]: the computer circuitry is configured to amplify the neural activity detected by the electrode array and digitize the neural activity to obtain digital neural activity information).
Regarding claim 8, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the signal acquisition component is coupled to a clinical data acquisition system (external processing device 150 in Fig. 1B; [0036]: the wired connector 140 connects the processing unit 120 to the external processing device 150).
Regarding claim 9, the Negi/Kipke/Shah combination discloses the invention substantially in claim 1 and described above.
Kipke further teaches that the signal acquisition device comprises a coiled lead (Kipke Col 5, lines 64-67 – Col 6, lines 1-12: the traces form helically coiled groups). Utilizing coiled leads of microwires is an obvious alternative to the ribbon-cable of Negi that would both maintain functionality and not result in any unexpected outcomes. 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 substitute the micro-ribbon cable of Negi for the helically coiled lead of Kipke such that the cable is replaced with the coiled lead to transfer signals between the electrodes and the signal acquisition component.
Regarding claim 10, the Negi/Kipke/Shah combination discloses the invention substantially in claim 9/1 and described above. The combination further teaches that a single trace can service a plurality of electrodes (trace 120 connects to multiple electrodes 115 as seen in Kipke Fig. 1). The electrodes can be microelectrodes or macroelectrodes (Fig. 3B of Negi).
Regarding claim 18, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the electrode array comprises from 4 to 500 uniformly or non-uniformly arranged macroelectrodes (there are 28 macroelectrodes 360 arranged in a uniform spoke pattern as shown in Fig. 3B).
Regarding claim 19, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the macroelectrodes comprise diameters from 1 mm to 10 mm ([0053]: the sites of the macroelectrodes are 2mm in diameter).
Regarding claim 21, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the electrode array comprises from 100 to 10,000 uniformly or non-uniformly arranged microelectrodes ([0053]: there are 100 microelectrode sites arranged uniformly in a spoke pattern).
Regarding claim 22, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the microelectrodes comprise diameters from 1 µm to 1 mm ([0053]: the diameter of the microelectrode sites is 50 µm).
Regarding claim 23, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the microelectrodes are spaced from 100 µm to 5 mm apart from each other ([0054]: the microelectrode sites are spaced at 400 µm).
Regarding claim 24, the Negi/Kipke/Shah combination discloses the device according to claim 1, wherein the electrode array provides at least a 2-fold increase in spatial sampling resolution compared to an array comprising only macroelectrodes ([0053]: there are 28 macroelectrodes and 100 microelectrodes; this would provide well over a 2-fold increase in spatial sampling resolution compared to a macroelectrode array with only 3 macroelectrodes).
Regarding claim 26, the Negi/Kipke/Shah combination discloses the manufacturing method of the EEG device of claim 1 (Negi Fig. 6). The Negi/Kipke/Shah combination further discloses arranging a plurality of microelectrodes (microelectrodes 370 in Negi Fig. 3B) and macroelectrodes (macroelectrodes 360 in Negi Fig. 3B) uniformly or non-uniformly (arranged uniformly in a spoke formation as seen in Negi Fig. 3B) within a polymer-based substrate (Negi [0053]: the substrate housing the electrode is made of parylene) to form an electrode array (Negi step 710 in method 600: create an electrode grid by inserting a defined number of interconnections between a first and second parylene layer).
The Negi/Kipke/Shah combination further teaches that the electrode array has silicone backing attached (Kipke Col 6, lines 52-67).
Regarding claim 27, Negi discloses an electroencephalography (EEG) system ([0007]: the invention is a system for detecting and processing neural activity through ECoG, which is known in the art to be a type of EEG) comprising:
an electrode array (electrode grid 350 in Fig. 3B) comprising a plurality of microelectrodes (microelectrodes 370 in Fig. 3B) and macroelectrodes (macroelectrodes 380 in Fig. 3B) uniformly or non-uniformly arranged (microelectrodes and macroelectrodes are uniformly arranged as seen in Fig. 3B) in a polymer-based substrate ([0053]: the array is a 128 channel, 20 µm thick Parylene-C based array);
a signal acquisition component (signal processing component 120 in Fig. 1A) coupled to the electrode array ([0033]: the processing unit is connected to the electrode array as seen in Fig. 1A and 1B) configured to collect and transmit electrical signals obtained from a subject's brain ([0033]: the signal processing unit 120 is configured to amplify the neural activity detected by the intracranial electrode grid, digitize the neural activity to obtain digital neural activity information, and multiplex the digital neural activity information prior to transmission of the digital neural activity information);
wherein the signal acquisition component comprises at least one lead (cable 130 in Fig. 1C) comprising a plurality of traces ([0034]: cable 130 is a micro-ribbon cable that is constructed; [0052]: the micro-ribbon cable includes conductive traces; cable 130 and cable 310 correspond to the same micro-ribbon cable for connecting the electrodes to the processing component); wherein the at least one lead comprises traces consisting of gold ([0052]: the conductive traces are gold); and
a clinical data acquisition system (external signal processing device 150 in Fig. 1B).
Negi further discloses that the macroelectrodes and the microelectrodes emanate from the ribbon cable as seen in Fig. 3B ([0053]).
While it is the examiner’s position that the traces of the ribbon-cable connect to contact points on the electrodes to facilitate signal transmission is inherent, Negi does not outright disclose the microwires extending from contact points on the electrodes.
Kipke teaches an electrode array used for ECoG measurement (Col 1, lines 20-38). Kipke further teaches that device can include individual traces that can be gathered to form helically coiled groups, which are leads of microwires (Col 5, lines 64-67 – Col 6, lines 1-12). The traces connect the electrodes to the electronic subsystem 440, performing the same function as the cable from Negi (Col 3, lines 58-67 – Col 4, lines 1-10). The traces are used to connect to the electrodes such that the signals are transferred from the electrodes through the traces to the electronic subsystem which can send them on for further processing (Col 3, lines 58-67 – Col 4, lines 1-10). Ensuring the microwires/traces contact the electrodes is an obvious combination in order to facilitate signal transmission between the electrodes and the processing device. 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 microwire connection of Kipke with the device of Negi such that the traces connect to the electrodes to facilitate signal transmission between the electrodes and the processing device.
However, the Negi/Kipke combination is silent to the size of the traces.
Negi describes in paragraph [0055] that the electrode array is composed of a first parylene layer 404 that is 5µm thick and a second layer that is 15µm with the gold layer sandwiched between as seen in Fig. 4D. According to figure 4D, the gold, which the traces are composed of, appears to be approximately the same size as the layer 404. While this is focused on the electrode grid itself and does not specifically state the size of the traces, it indicates that Negi teaches a conductive gold layer close to the claimed size.
Shah teaches a thin-film lead assembly and neural interface that includes one or more conductive traces in electrical connection with electrodes ([Abstract]). The conductive traces can be made of pure gold and can have a thickness from about 0.5µm to about 10 µm ([0070]-[0071]). Shah goes on to further state that the thickness of the conductive traces is dependent on the particular impedance desired for the conductor in order to ensure excellent signal integrity ([0071]). Shah further teaches that the thin-film neural interface is improved over the standard devices because it is smaller and has greater flexibility ([0060]). If the overall device has enhanced flexibility, the gold traces contribute to that. Utilizing the size of the conductive traces of Shah for the traces of the Negi/Kipke combination would be of routine skill in the art as Negi contemplates the use of gold at a similar size. Furthermore, it would have been an obvious matter of design choice to set the thickness of the traces to about 5 micrometers, since such a modification would have involved a mere change in the size of a component and the applicant has not assigned criticality to the size of 5 micrometers simply through the use of “about” which indicates a degree of variability. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gold traces to be 5µm thick because Shah teaches modifying the trace thickness within a range that includes the claimed thickness to modify the desired resistance value and doing so is merely a change in the size of the traces which is well within an ordinary level of skill in the art.
Regarding claim 34, the Negi/Kipke/Shah combination discloses a method of evaluating a subject for a neurological impairment, the method comprising:
recording electrical signals in a portion of a subject's brain using the EEG device of claim 1 ([0046]: the ECoG system records and communicates the brain electrical activity); and
evaluating the subject based on the recorded electrical signals ([0004]: physicians use ECoG recordings to investigate long-range neural circuitry and synchronization and to monitor epilepsy conditions).
Regarding claim 40, the Negi/Kipke/Shah combination discloses the invention substantially in claim 1 as described above wherein the at least one lead is configured to withstand repeated bending to 90° for over 47,000 cycles without breaking (this is an inherent property of the lead and the Negi/Kipke/Shah combination discloses the structure of the lead substantially as described above. Therefore, because the structure recited in the claim is substantially identical to the reference, the claimed properties are presumed to be inherent. See MPEP 2112.01. The claimed properties of the lead are that it is composed of 5µm thick gold microwires which is disclosed by Negi and Shah as described above).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the Negi/Kipke/Shah combination as applied to claim 1 and described above, in view of Stolk et al. (hereinafter ‘Stolk’, Integrated analysis of anatomical and electrophysiological human intracranial data).
Regarding claim 3, the Negi/Kipke/Shah combination discloses the device substantially in claim 1 and described above.
However, the combination does not disclose the electrode array configured to perform SEEG on the subject.
Stolk teaches a comprehensive protocol that addresses the complexities associated with human iEEG ([Abstract]). Stolk further teaches utilizing iEEG for simultaneous recordings of both ECoG and SEEG through the implantation of 96 ECoG and 56 SEEG electrodes ([Experimental Design]). Utilizing iEEG where both ECoG and SEEG are used allows for much more detailed information to be collected compared to less invasive EEG measurement techniques in order to identify epileptogenic zones as well as map the functionally eloquent areas of the human cortex to guide neurosurgery ([Introduction]). 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 SEEG functionality with the electrode array of the Negi/Kipke/Shah combination in order to provide more detailed information of the patient’s brain function.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the Negi/Kipke/Shah combination as applied to claim 1 and described above, in view of Bonmassar et al. (hereinafter ‘Bonmassar’, US 20150099959 A1).
Regarding claim 6, the Negi/Kipke/Shah combination discloses the invention substantially in claim 1 and described above.
Bonmassar teaches an electrode array for implantation into a subject including electrodes connected to conductive traces, similar to the Negi/Kipke/Shah combination ([Abstract]). Bonmassar further teaches the electrode array can be used for ECoG recording ([0077]). The electrode array utilizes dielectric binders including polyimides, silicones, polyethylene, polyvinylchloride, polyurethanes, polylactides, elastomer gels, urethanes, block copolymers, and liquid crystal polymers ([0035]). The LCP fibers possess unique properties like creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility ([0048]). 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 polymer-based substrate of the Negi/Kipke/Shah combination with the LCP addition of Bonmassar which imparts desirable qualities such as creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Stolk in view of Negi, Kipke, and in further view of Shah.
Regarding independent claim 25, Stolk discloses an ECoG-SEEG combination device ([Experimental Design]: an iEEG that contains neural recordings from both cortical grid (ECoG) and stereotactically inserted depth electrodes (SEEG)) comprising:
an ECoG component ([Experimental Design]: cortical grid electrodes) comprising an electrode array ([Experimental Design]: 96 ECoG electrodes) and a signal acquisition component ([Neural Recordings]: Nihon Kohden recording system) coupled to the electrode array ([Neural Recordings]: the Nihon Kohden recording system recorded the data from the electrodes which in turn discloses coupling) configured to collect ([Neural Recordings]: the system recorded the activity) and transmit ([Experimental Design]: the results are available for download) electrical signals obtained from a subject’s brain; and
an SEEG component ([Experimental Design]: stereotactically inserted depth electrodes) comprising an electrode array ([Experimental Design]: 56 SEEG electrodes) and a signal acquisition component ([Neural Recordings]: Nihon Kohden recording system) coupled to the electrode array ([Neural Recordings]: the Nihon Kohden recording system recorded the data from the electrodes which in turn discloses coupling) configured to collect ([Neural Recordings]: the system recorded the activity) and transmit ([Experimental Design]: the results are available for download) electrical signals from the patient’s brain.
However, Stolk does not disclose the use of micro or macroelectrodes uniformly or non-uniformly spaced on a polymer-based substrate and the signal acquisition component comprising a lead formed of a plurality of microwires connected to the electrodes wherein the at least one lead is comprised of gold.
Negi teaches an iEEG system configured to measure neural activity ([0003]-[0007]). Negi further teaches an electrode array comprising a plurality of micro and macroelectrodes arranged in a uniform spoke pattern on a parylene-C based substrate ([0053]). This configuration allows for the diffusion and passage of fluid around the electrodes but across the grid to the holes 380 ([0053]). Furthermore, the design is both biocompatible and on a flexible substrate that reduces complications and facilitates long term recordings ([0029]). 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 ECoG-SEEG electrode arrays of Stolk with the array design of Negi to allow for long term recordings and reduce fluid buildup under the electrode grid.
Negi further teaches that the signal acquisition component comprises a micro-ribbon cable consisting of gold conductive traces ([0034], [0052], [0054]). The cable connects the intracranial electrode grid and the subcutaneous signal processing unit ([0034]) and the macroelectrodes and the microelectrodes emanate from the ribbon cable as seen in Fig. 3B ([0053]). The cable is a thin, highly flexible, biocompatible cable that facilitates the transport of neural activity collected by the intracranial electrode grid to the processing unit for processing ([0034]). It would be obvious to one of ordinary skill in the art to utilize such a lead to connect the electrode grid to the processing unit as doing so would facilitate signal transmission and using a cable that is thin, highly flexible, and biocompatible which imparts all of those desirable properties to the connection of the device. 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 the micro-ribbon cable of Negi with the device of Stolk such that the connection between the electrodes and the signal processing unit is thin, highly flexible, and biocompatible and facilitates data transmission.
While it is the examiner’s position that the traces of the ribbon-cable connect to contact points on the electrodes to facilitate signal transmission is inherent, Negi does not outright disclose the microwires extending from contact points on the electrodes.
Kipke teaches an electrode array used for ECoG measurement (Col 1, lines 20-38). Kipke further teaches that device can include individual traces that can be gathered to form helically coiled groups, which are leads of microwires (Col 5, lines 64-67 – Col 6, lines 1-12). The traces connect the electrodes to the electronic subsystem 440, performing the same function as the cable from Negi (Col 3, lines 58-67 – Col 4, lines 1-10). The traces are used to connect to the electrodes such that the signals are transferred from the electrodes through the traces to the electronic subsystem which can send them on for further processing (Col 3, lines 58-67 – Col 4, lines 1-10). Ensuring the microwires/traces contact the electrodes is an obvious combination in order to facilitate signal transmission between the electrodes and the processing device. 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 microwire connection of Kipke with the device of the Stolk/Negi combination such that the traces connect to the electrodes to facilitate signal transmission between the electrodes and the processing device.
However, the Stolk/Negi/Kipke combination is silent to the size of the traces.
Negi describes in paragraph [0055] that the electrode array is composed of a first parylene layer 404 that is 5µm thick and a second layer that is 15µm with the gold layer sandwiched between as seen in Fig. 4D. According to figure 4D, the gold, which the traces are composed of, appears to be approximately the same size as the layer 404. While this is focused on the electrode grid itself and does not specifically state the size of the traces, it indicates that Negi teaches a conductive gold layer close to the claimed size.
Shah teaches a thin-film lead assembly and neural interface that includes one or more conductive traces in electrical connection with electrodes ([Abstract]). The conductive traces can be made of pure gold and can have a thickness from about 0.5µm to about 10 µm ([0070]-[0071]). Shah goes on to further state that the thickness of the conductive traces is dependent on the particular impedance desired for the conductor in order to ensure excellent signal integrity ([0071]). Shah further teaches that the thin-film neural interface is improved over the standard devices because it is smaller and has greater flexibility ([0060]). If the overall device has enhanced flexibility, the gold traces contribute to that. Utilizing the size of the conductive traces of Shah for the traces of the Stolk/Negi/Kipke combination would be of routine skill in the art as Negi contemplates the use of gold at a similar size. Furthermore, it would have been an obvious matter of design choice to set the thickness of the traces to about 5 micrometers, since such a modification would have involved a mere change in the size of a component and the applicant has not assigned criticality to the size of 5 micrometers simply through the use of “about” which indicates a degree of variability. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the gold traces to be 5µm thick because Shah teaches modifying the trace thickness within a range that includes the claimed thickness to modify the desired resistance value and doing so is merely a change in the size of the traces which is well within an ordinary level of skill in the art.
Response to Arguments
Applicant’s arguments, see page 6, filed 2/23/2026, with respect to the 112b rejections of independent claims 1, 25, and 27 have been fully considered and are persuasive in light of the amendments. The 112b rejections of claims 1-10, 18-19, 21-27, 34, and 40 have been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 25, and 27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Bonmassar is no longer used to teach the thickness of the traces and instead Shah has been used in combination with Negi and Kipke to teach the thickness of the traces. This switch was made in order to advance prosecution. While Bonmassar was merely used to teach the size of the traces, Shah teaches pure gold traces that can be 5µm thick which renders the applicant’s arguments moot.
The rejections to the dependent claims are maintained because the rejections to the independent claims are maintained.
Applicant’s arguments regarding Stolk have been fully considered but are not persuasive because the applicant does not specifically challenge the use of Stolk.
Conclusion
THIS ACTION IS MADE FINAL. 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 WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794