DETAILED ACTION
This action is pursuant to RCE filed on 6/23/2026. Claims 1-5, 7-10, 18-19, 21-27, 34, and 40 are pending, claim 6 has been cancelled by the applicant. A non-final action on the merits of claims 1-5, 7-10, 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/2026 has been entered.
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.
Claim 25 is 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 25 lists an “ECOG component comprising an electrode array comprising a plurality of microelectrodes and macroelectrodes […] arranged in a liquid crystal polymer (LCP)-based substrate […] and a signal acquisition component” and “an SEEG component comprising an electrode array comprising a plurality of microelectrodes and macroelectrodes […] arranged in a liquid crystal polymer (LCP)-based substrate , and a signal acquisition component” and then goes on to claim “wherein the signal acquisition component comprising a plurality of microwires extending from contact points on the plurality of microelectrodes and macroelectrodes […] and wherein the plurality of microwire traces are fully encased in the LCP-based substrate.” The bolded portions are added for emphasis. Claim 25 introduces two sets of microelectrodes and macroelectrodes, two LCP-based substrates, and two signal acquisition components – one for the ECOG component and one for the SEEG component. It is unclear which component the bolded groups are intended to be a part of since they are labelled identically. Therefore, claim 25 is rejected because it is unclear which component, the ECOG or the SEEG, the last clause is intended to limit. For the purposes of compact prosecution, it will be interpreted as a single electrode array comprising a plurality of microelectrodes and macroelectrodes, a single LCP substrate, and a single signal acquisition component that can function for both ECOG and SEEG which is consistent with claims 1-3 which claim the same subject matter.
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), in view of Shah et al. (US 20220175320 A1), and in further view of Bonmassar et al. (hereinafter ‘Bonmassar’, US 20150099959 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 additionally discloses that the conductive material based interconnections can be sandwiched between two parylene layers ([0054]) and that the cable can be constructed of a polymer such as parylene ([0034]).
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.
However, the Negi/Kipke/Shah combination is silent to the polymer substrate being LCP-based and the microwire traces being fully encased in the LCP substrate.
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 traces 16 are electrically isolated from each other by dielectric material 18 ([0029]). Layering the dielectric material over the traces provides for environmental protection and electrical isolation ([0040]). The dielectric binders, on top of which the conductive inks are deposited, can including polyimides, silicones, polyethylene, polyvinylchloride, polyurethanes, polylactides, elastomer gels, urethanes, block copolymers, and liquid crystal polymers ([0035]-[0036]). As seen in Fig. 2B, the dielectric is deposited onto the Gelfilm, the trace 16 is deposited on top of the dielectric, and then another layer of dielectric is deposited on top of the trace. As stated in claim 2 and paragraph [0042], the thermoplastic binder binds with the organic substrate and then receives the conductive trace. This shows that “dielectric” and “dielectric binder” are used interchangeably throughout Bonmassar to describe the layers that are on either side of the conductive trace. Bonmassar further states that the lead that extends from the electrode array can also be made of Liquid Crystal Polymer ([0048]). Utilizing LCP imparts unique properties like creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility ([0048]). Furthermore, modifying the parylene that encapsulates the conductors and the lead of Negi to be the LCP taught by Bonmassar would be of routine skill in the art since it is merely material selection from known materials in the art. 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 parylene substrate and lead of the Negi/Kipke/Shah combination to be an LCP as taught by Bonmassar such that the traces are fully encased in the LCP in the substrate and through the lead to allow for environmental protection, electrical isolation, creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility of the traces and substrate. This is consistent with Fig. 17 of the instant application wherein the leads are encased in LCP in the substrate and then extend away from the substrate to form a lead.
Regarding claim 2, the Negi/Kipke/Shah/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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/Bonmassar 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 the LCP-based substrate (the substrate is LCP as described in the combination above and the electrodes are arranged throughout as seen in Negi) 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/Bonmassar combination further teaches that the electrode array has silicone backing attached (Kipke Col 6, lines 52-67).
Regarding independent 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 additionally discloses that the conductive material based interconnections can be sandwiched between two parylene layers ([0054]) and that the cable can be constructed of a polymer such as parylene ([0034]).
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.
However, the Negi/Kipke/Shah combination is silent to the polymer substrate being LCP-based and the microwire traces being fully encased in the LCP substrate.
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 traces 16 are electrically isolated from each other by dielectric material 18 ([0029]). Layering the dielectric material over the traces provides for environmental protection and electrical isolation ([0040]). The dielectric binders, on top of which the conductive inks are deposited, can including polyimides, silicones, polyethylene, polyvinylchloride, polyurethanes, polylactides, elastomer gels, urethanes, block copolymers, and liquid crystal polymers ([0035]-[0036]). As seen in Fig. 2B, the dielectric is deposited onto the Gelfilm, the trace 16 is deposited on top of the dielectric, and then another layer of dielectric is deposited on top of the trace. As stated in claim 2 and paragraph [0042], the thermoplastic binder binds with the organic substrate and then receives the conductive trace. This shows that “dielectric” and “dielectric binder” are used interchangeably throughout Bonmassar to describe the layers that are on either side of the conductive trace. Bonmassar further states that the lead that extends from the electrode array can also be made of Liquid Crystal Polymer ([0048]). Utilizing LCP imparts unique properties like creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility ([0048]). Furthermore, modifying the parylene that encapsulates the conductors and the lead of Negi to be the LCP taught by Bonmassar would be of routine skill in the art since it is merely material selection from known materials in the art. 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 parylene substrate and lead of the Negi/Kipke/Shah combination to be an LCP as taught by Bonmassar such that the traces are fully encased in the LCP in the substrate and through the lead to allow for environmental protection, electrical isolation, creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility of the traces and substrate. This is consistent with Fig. 17 of the instant application wherein the leads are encased in LCP in the substrate and then extend away from the substrate to form a lead.
Regarding claim 34, the Negi/Kipke/Shah/Bonmassar 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/Bonmassar 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/Bonmassar 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). Additionally, this is a functional limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim. In this specific case, the claimed structure of the lead is the same as the prior art as described above and is thus interpreted as functioning in the same manner.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the Negi/Kipke/Shah/Bonmassar 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/Bonmassar 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 electrodes and 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 25 is rejected under 35 U.S.C. 103 as being unpatentable over Stolk in view of Negi, Kipke, Shah, and in further view of Bonmassar.
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]). Negi additionally discloses that the conductive material based interconnections can be sandwiched between two parylene layers ([0054]). 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]). Negi additionally discloses that the cable can be constructed of a polymer such as parylene ([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.
However, the Stolk/Negi/Kipke/Shah combination is silent to the polymer substrate being LCP-based and the microwire traces being fully encased in the LCP substrate.
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 traces 16 are electrically isolated from each other by dielectric material 18 ([0029]). Layering the dielectric material over the traces provides for environmental protection and electrical isolation ([0040]). The dielectric binders, on top of which the conductive inks are deposited, can including polyimides, silicones, polyethylene, polyvinylchloride, polyurethanes, polylactides, elastomer gels, urethanes, block copolymers, and liquid crystal polymers ([0035]-[0036]). As seen in Fig. 2B, the dielectric is deposited onto the Gelfilm, the trace 16 is deposited on top of the dielectric, and then another layer of dielectric is deposited on top of the trace. As stated in claim 2 and paragraph [0042], the thermoplastic binder binds with the organic substrate and then receives the conductive trace. This shows that “dielectric” and “dielectric binder” are used interchangeably throughout Bonmassar to describe the layers that are on either side of the conductive trace. Bonmassar further states that the lead that extends from the electrode array can also be made of Liquid Crystal Polymer ([0048]). Utilizing LCP imparts unique properties like creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility ([0048]). Furthermore, modifying the parylene that encapsulates the conductors and the lead of Negi to be the LCP taught by Bonmassar would be of routine skill in the art since it is merely material selection from known materials in the art. 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 parylene substrate and lead of the Negi/Kipke/Shah combination to be an LCP as taught by Bonmassar such that the traces are fully encased in the LCP in the substrate and through the lead to allow for environmental protection, electrical isolation, creep resistance, abrasion resistance, flexibility, minimal moisture absorption, and good biocompatibility of the traces and substrate. This is consistent with Fig. 17 of the instant application wherein the leads are encased in LCP in the substrate and then extend away from the substrate to form a lead.
Response to Arguments
Applicant’s arguments regarding the improper finality have been fully considered but are not persuasive. The applicant altered the scope of the independent claims. The applicant changed the language from "comprised of" to "consisting of". This singular change narrows the scope of the claim and allows for new art to be applied. While the examiner did interpret the microwires as traces, the applicant narrowed the material which the traces can be made of which necessitated new grounds of rejection.
Applicant’s arguments that none of the references teach the traces encased in the LCP-substrate have been fully considered but are moot because the new grounds of rejection relies on Bonmassar to teach the newly added limitation.
Applicant’s arguments that Negi does not teach microwires extending from contact points have been fully considered but are not persuasive. The examiner states that this contact point is inherent because the traces must be connected to points on the electrode in order to transmit the sensed signal. If the traces do not contact the electrodes, the signals could not be transmitted.
However, the examiner combines Negi with Kipke to address this limitation and does not solely rely on inherency for the rejection.
The applicant further states that Kipke is used to supply the missing microwire feature. However, this is an incorrect reading of the office action. Kipke is used to teach the contact point between the electrode and the microwire trace, not to teach the trace as a whole.
Additionally, the applicant's arguments regarding the "macroelectrodes" of Kipke are not persuasive. The applicant states that the macroelectrodes of Kipke are not distinct electrode structures and thus Kipke does not teach contacting macroelectrodes. This is not persuasive. Negi already teaches distinct macro and micro electrodes. Kipke is simply used to teach that the microwires must contact the electrodes in order to facilitate signal transmission. No matter the size of the electrodes, the logic that microwires must contact the electrodes for signal transmission is obvious to one of ordinary skill in the art.
Furthermore, the applicant's arguments that the motivation for the combination of Negi and Kipke being insufficient is not persuasive. The applicant states that the motivation listed by the examiner is "maintain functionality and not result in any unexpected outcomes." However, this is not the rationale provided in the office action. The office action states the motivation "to facilitate signal transmission between the electrodes and the processing device". Ensuring signal transmission between the electrodes and the processing device is an obvious motivation for one of ordinary skill in the art to teach the traces contacting the electrodes.
Applicant’s arguments regarding Shah have been fully considered but are not persuasive. The applicant states that it cannot be a mere design choice while also determining the impedance of the traces. However, this is not persuasive. Selecting the desired thickness of the traces is a design choice for ensuring the desired signal integrity and desired impedance parameter. That is precisely why Shah discloses a range of thicknesses from which to choose. As stated in the office action, selecting a thickness from the range disclosed by Shah is a design choice that one of ordinary skill in the art would make based on the desired impedance parameters and signal integrity. Selecting any value within this range would be well within an ordinary level of skill in the art in view of Shah.
Additionally, Fig. 4D is not relied upon to teach the exact sizes of the traces. It is simply used to show that it appears the applicant contemplates using gold conductors that are approximately the claimed thickness. Shah is used to teach the thickness. Relying on a cross-section of the figure to show an approximate size is not improper if it is not solely relied upon for the rejection. That statement is simply used to show it was contemplated, not that it is explicitly disclosed.
Furthermore, the instant application does not provide any criticality to this thickness, nor does the instant application define the deviation from the value to satisfy "about." 0.5 microns to 10 microns is a range of values which is close to 5 microns, thus it is interpreted as being "about 5 microns" since the claim and the specification do not define how close to 5 microns the thickness must be.
Applicant's arguments regarding claim 40 not being an inherent result of the claimed structure have been fully considered but are not persuasive. The combination of record has the same structure as claimed, gold traces that are about 5 microns thick encased in LCP. This is the same structure that is disclosed in the specification and the claims of the instant application. Since the structure is the same, it would inherently function in the same manner. Should the applicant wish to differentiate over the combination of record, specific structure must be claimed that differentiates over the prior art.
Additionally, this is a functional limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim. In this specific case, the claimed structure of the lead is the same as the prior art as described above and is thus interpreted as functioning in the same manner.
Applicant's arguments regarding Stolk as applied to claim 3 have been fully considered but are not persuasive. Applicant states that there is no structural basis for the combination. However, claim 3 is purely functional. There is no unique structure claimed in claim 3 that provides for the ability to measure SEEG. Stolk is used to teach that combining ECOG and SEEG functionality provides more detailed information of the patient's brain. Stolk is very clear that combining both ECOG electrodes with SEEG electrodes allows for a better map of the brain's functionality. Should the applicant wish to overcome this combination, specific structures allowing for the SEEG functionality must be claimed. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the claim, then it meets the claim. In the current case, providing the Negi/Kipke/Shah/Bonmassar combination with SEEG electrodes to impart SEEG functionality is an obvious benefit and there is no specific structure claimed to overcome this combination.
Applicant’s arguments regarding claim 35 have been fully considered but are not persuasive. Applicant's arguments that it is methodologically unjustified to utilize Stolk as the primary reference for the rejection of claim 25 are not persuasive. Stolk teaches key structure and functions of the claim as outlined in the rejection. Utilizing teaching reference to teach the outlined differences is standard practice. Stolk teaches several of the claimed limitations and the teaching references are provided to teach the differences.
Applicant’s arguments regarding the LCP substrate as applied to claim 25 have been fully considered but are moot because Bonmassar is used to teach the newly claimed limitation.
Applicant’s arguments with regards to the combination of Negi, Kipke, and Shah have been addressed above and apply with equally to claim 25.
Applicant's arguments regarding claim 24 have been fully considered but are not persuasive. The applicant states that that the reasoning provided for the rejection is arbitrary. However, as written, the claim is incredibly broad. The claim does not state what the 2-fold increase in spatial sampling resolution is compared against, nor does the applicant claim the number of electrodes. When there is no baseline for the improvement, it can be any arbitrary initial sampling resolution. That is specifically why the office action outlines that the combination of record would provide a spatial sampling resolution increase well-over 2-fold of an array of only 3 macroelectrodes. There is no baseline for the increase, so the examiner simply set the baseline to 3 macroelectrodes since that constitutes an array of only macroelectrodes. Should the applicant wish to overcome this rejection, specific structure differentiating over the prior art must be claimed.
Conclusion
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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/W.M./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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