DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/24/2025 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks pg. 7-9, filed 7/24/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive in view of the amendment which requires the contact part and/or connection part have a serpentine mesh structure. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wang et al. (CN 108324274). See rejection below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Negi et al. (US 2015/0305643) (hereinafter Negi) in view of Lu et al. (Lu, Y., Lyu, H., Richardson, A. G., Lucas, T. H., & Kuzum, D. (2016b). Flexible neural electrode array based-on porous graphene for cortical Microstimulation and sensing. Scientific Reports, 6(1)) (hereinafter Lu), further in view of Wang et al. (CN 108324274) (hereinafter Wang).
Regarding claim 1, Negi discloses a brain signal measurement and stimulation structure (Abstract; Fig. 1C depicts recording & stimulation via wires 140, 142) comprising: a flexible element comprising a contact part configured to be in contact with the surface of a cerebral cortex to measure a signal generated in the brain or transmit an external stimulus to the brain (Fig. 1A-C, intracranial electrodes 110; para. 29 describes electrodes on flexible substrate, flexible neural interface), a transmitting/receiving part positioned between a skull and a skin (Fig. 1A-C, percutaneous microelectronic signal processing component 120), and a connection part configured to connect the contact part and the transmitting/receiving part (Fig. 1a-c, cable 130); and an integrated circuit connected to the transmitting/receiving part to transmit and receive a signal (Fig. 2A depicts integrated circuitry 220 of microelectronic signal processor 120).
Negi does not disclose wherein the flexible element comprises a lower-layer support substrate, a graphene electrode layer and a wiring layer formed on the lower-layer support substrate, and an insulation layer formed on the graphene electrode layer and the wiring layer, the insulation layer is etched such that the graphene electrode layer is partially exposed, and a part of the graphene electrode layer and a part of the wiring layer are adjacently connected, and wherein at least one of the contact part and the connection part have a serpentine mesh structure.
Lu, however, teaches a flexible neural electrode array based on graphene for cortical microstimulation and sensing (Title) wherein a flexible electrode comprises a lower-layer support substrate, a graphene electrode layer (Fig. 1a-b depicts laser pyrolysis on polyimide substrate to form graphene electrodes; see pg. 2, “Results and Discussion”) and a wiring layer formed on the lower-layer support substrate (Fig. 1b depicts addition of Au metal interconnects, see pg. 2 “Results and Discussion”), and an insulation layer formed on the graphene electrode layer and the wiring layer, the insulation layer is etched such that the graphene electrode layer is partially exposed (Fig. 1c depicts addition of etched SU-8 insulation layer to graphene electrodes and wiring, SU-8 layer being etched such that each graphene electrode is exposed; see also pg. 2 “Results and Discussion”), and a part of the graphene electrode layer and a part of the wiring layer are adjacently connected (Fig. 1b depicts interconnection of wiring and graphene electrodes). Lu also teaches that porous graphene electrodes show superior impedance and charge injection characteristics making them ideal for high efficiency cortical sensing and stimulation. They exhibit no physical delamination or degradation even after 1 million biphasic stimulation cycles, confirming high endurance (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Negi such that the flexible element comprises a lower-layer support substrate, a graphene electrode layer and a wiring layer formed on the lower-layer support substrate, and an insulation layer formed on the graphene electrode layer and the wiring layer, the insulation layer is etched such that the graphene electrode layer is partially exposed, and a part of the graphene electrode layer and a part of the wiring layer are adjacently connected. Making this modification would be useful for providing efficient electrophysiological sensing and stimulation from the brain surface, without penetrating into the tissue, as taught by Lu (Abstract).
Furthermore, Wang teaches an electrode device comprising a contact part and connection part with a serpentine mesh structure (Abstract; Fig. 2 depicts serpentine mesh structure of interconnecting conductor 2; Fig. 5 depicts contact part 1 with serpentine mesh structure). Wang further teaches the total thickness of the device is only several microns and has ductility and complex curved irregular shape with good adaptability (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Negi in view of Lu such that at least one of the contact part and the connection part have a serpentine mesh structure. Making this modification would be useful such that the total thickness of the device is only several microns and has ductility and complex curved irregular shape with good adaptability, as taught by Wang.
Regarding claim 8, modified Negi teaches the lower-layer support substrate is polyimide (PI) (Lu pg. 2, under “Results and Discussion”).
Regarding claim 9, modified Negi teaches the graphene electrode comprises one to four layers (Lu Fig. 1 depicts between one and four graphene electrode layers).
Regarding claim 10, modified Negi does not teach the graphene electrode layer has a diameter of 30 to 150 microns. Instead, modified Negi teaches the graphene electrode layer has a diameter of about 250 microns (Lu Fig. 1e).
The Examiner submits that the claimed 30 to 150 microns range is so close to the taught 250 microns that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a graphene layer with a 250 micron diameter to have the same properties as a graphene layer with 30 to 150 micron diameter (MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of ‘having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium’ as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. ‘The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.’). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
Regarding claim 11, modified Negi teaches the wiring layer is formed of gold (Au) (Lu, see pg. 2, under “Results and Discussion”).
Regarding claim 12, modified Negi does not teach the wiring layer has a thickness of 30 to 60 nm. Instead, Lu teaches the wiring layer has a thickness of 100 nm (pg. 2, under “Results and Discussion”).
The Examiner submits that the claimed 30 to 60 nm range is so close to the taught 100 nm that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a wiring layer with a 100 nm thickness to have the same properties as a wiring layer with 30 to 60 nm thickness (MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of ‘having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium’ as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. ‘The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.’). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
Regarding claim 13, modified Negi teaches the insulation layer is formed of SU-8 (Lu Fig. 1c caption; “Results and Discussion”).
Regarding claim 14, modified Negi does not teach the flexible element and the integrated circuit are injected into the brain of an animal other than a human to receive a brain signal, provide the received brain signal to the outside of the body, and apply one stimulus selected from current, voltage, magnetic field, or electric field stimulus to the brain.
The Examiner submits that these limitations amount to an intended use of the claimed invention. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114(II): “‘[A]pparatus 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) (emphasis in original). A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)”).
In this case, the Examiner submits that since modified Negi appears to teach all of the required structural limitations of claim 1 and no further structure appears to be set forth for achieving the claimed functions of claim 14, modified Negi would be capable of having the flexible element and the integrated circuit injected into the brain of an animal other than a human to receive a brain signal, provide the received brain signal to the outside of the body, and apply one stimulus selected from current, voltage, magnetic field, or electric field stimulus to the brain.
Claims 3 and 5 is rejected under 35 U.S.C. 103 as being unpatentable over modified Negi in view of Byun et al. (KR 2012-0077585) (hereinafter Byun).
Regarding claim 3, modified Negi does not teach a surface of the insulation layer undergoes hydrophilic surface treatment.
Byun, however, teaches a microelectrode array and fabrication method (Abstract) wherein hydrophilic surface treatment may be performed on one surface of an insulator to provide firm contact with another component of the electrode (pg. 4, last para.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Negi such that a surface of the insulation layer undergoes hydrophilic surface treatment. Making this modification would be useful for providing firm contact with another component of the electrode, as taught by Byun.
Regarding claim 5, the Examiner submits that this is a product-by-process claim which claims a specific process of making a surface of the insulation layer hydrophilic. As per MPEP 2113(I): “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009).
In this case, modified Negi along with the teachings of Byun provides the hydrophilic surface as described in the rejection of claim 3 above. The prior art thus meets the required structure and, even though made by a different process, claim 5 is nevertheless read upon by modified Negi and Byun as applied to claim 3.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over modified Negi in view of Scheuermann (US 2010/0125319).
Regarding claim 4, modified Negi does not teach a partial surface of the lower-layer support substrate undergoes hydrophobic surface treatment.
Scheuermann, however, teaches a cell-repelling electrode (Abstract) wherein one or more electrodes includes a structured surface configured to exhibit hydrophobic qualities. The hydrophobic qualities advantageously inhibit tissue in growth and/or attachment to the electrode surface (para. 24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Negi such that a partial surface of the lower-layer support substrate undergoes hydrophobic surface treatment. Making this modification would be useful for inhibiting tissue growth/attachment to the electrode, as taught by Scheuermann.
Regarding claim 6, the Examiner submits that this is a product-by-process claim which claims a specific process of making a surface of the support substrate hydrophobic. As per MPEP 2113(I): “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009).
In this case, modified Negi along with the teachings of Scheuermann provides the hydrophobic surface as described in the rejection of claim 4 above. The prior art thus meets the required structure and, even though made by a different process, claim 6 is nevertheless read upon by modified Negi and Scheuermann as applied to claim 4.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over modified Negi in view of Khayrullaev et al. (US 2018/0317875) (hereinafter Khayrullaev).
Regarding claim 7, modified Negi teaches the integrated circuit comprises a recording device and a stimulation device (para. 49, with reference to connectors 240, 242). Modified Negi does not teach the integrated circuit comprises a wireless power supply device and a communication device.
Khayrullaev, however, teaches a system for telemetrically monitoring a subject (Abstract) wherein a printed circuit board (PCB) includes a transceiver and wireless power charge unit (para. 34). It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify modified Negi’s integrated circuit to include these components in order to facilitate communications and wireless charging of the device, as suggested by Khayrullaev.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Osypka et al. (US 2009/0018630) discloses a self-expandable epidural cortical electrode (Abstract).
Oxley (US 2019/0336748) discloses systems for deep brain stimulation (Abstract) wherein electrode lead includes a serpentine shape (Fig. 7A).
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/ANANT A GUPTA/Examiner, Art Unit 3792
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