DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed on 02/04/2026 have been fully considered but are moot in view of a new grounds of rejection.
Nevertheless, to advance prosecution Examiner addresses the following argument
Applicant argues that Wangs structure merely shows that the electrode itself has a serpentine structure.
Regarding point (i), Examiner acknowledges that Wang discloses the electrode layer having a serpentine structure. Examiner notes that Wang also discloses other components of the electrode device having a serpentine structure including: a wiring layer (2; [0037]), a substrate layer (4; [0038]) and an encapsulation layer (5; [0041]) (as discussed in greater detail below (see section Claim Rejections 35 USC 103)). Examiner notes that although each polymer layer of Applicant’s instant invention may be made out of a serpentine structure, such a feature is not required by the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643), in view of Lu (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))), in view of Wang et al. (CN 108324274).
In re claim 1, Negi discloses, a brain signal measurement and stimulation structure comprising (abstract; FIGS. 1A- FIG.1C):
a flexible element (105; [0029] comprising
a contact part (110) configured to
be in contact with the surface of a cerebral cortex ([0030]: last sentence) to measure a signal generated in the brain ([0030]: “neural activity detected by the intracranial electrode grid”) and
transmit an external stimulus to the brain [0048],
a transmitting/receiving part (120) positioned between a skull and a skin (FIG. 1A), and
a connection part (130) configured to connect the contact part and the transmitting/receiving part (FIG. 1A); and
an integrated circuit (FIG. 2A: 220) connected to the transmitting/receiving part to transmit and receive a signal (FIG. 2A depicts integrated circuitry 220 of element 120 shown in FIGS. 1A-1C),
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,
wherein at least one of
the contact part and
the connection part
have a serpentine mesh structure, and have the lower-layer support substrate, the wiring layer, the graphene electrode layer and the insulation layer, and
wherein, at least one of the lower-layer support substrate, the wiring layer and the insulation layer has a serpentine 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. Specifically, 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, as taught by Lu. Making this modification would be useful for providing efficient electrophysiological sensing and stimulation from the brain surface, without penetrating into the tissue (Lu, Abstract).
Regarding the limitations “wherein at least one of the contact part and the connection part have a serpentine mesh structure” and “wherein, at least one of the lower-layer support substrate, the wiring layer and the insulation layer has a serpentine structure.”
Wang discloses a device (FIGS. 2-4 and FIG. 7) configured to receive electrical signals from tissue [0008]. The device, like the proposed combination, includes a contact portion (FIGS. 2-4: portion that contacts tissue comprised of 1, 2, 4 and 5), a transmitter/recivier (black box shown in in FIG. 7), and a connecting portion (3) that connects the contact portion to the transmitter/recivier (see FIG. 7). As described in Wang, the contacting portion is comprised of four layers (1, 2, 4, and 5) each with a serpentine structure: an electrode layer (1; [0036]), a wiring layer (2; [0037]), a substrate layer (4; [0038]) and an encapsulation layer (5; [0041]). As described in Wang, providing each layer with a serpentine structure ensures that the tissue stimulation device is soft, has excellent stretchability, and can be self-adaptively and rightly adhered on complex irregular shaped surfaces ([0008]: sentence starting with “The measuring electrode designed and prepared by this invention”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify the proposed combination to include wherein at least one of the lower-layer support substrate, the wiring layer, and the insulation layer has a serpentine structure, as taught by Wang. One would have been motivated to make this modification to improve tensile performance and ensure that the device of the proposed modification could be adhered to complex irregularly shaped surfaces (Wang, [0008]). Accordingly, such a modification would yield “wherein at least one of the contact part and the connection part have a serpentine mesh structure” given that all three layers are a part of the portion of the device that is configured to come into contact with a tissue, that is, the “contact part”.
In re claim 8, the proposed combination yields, wherein the lower-layer support substrate is one selected from the group consisting of polyethylene terephthalate (PET), polyimide (PI), polystyrene (PS), polycarbonate (PC), polyethersulfone (PES), polymethylmethacrylate (PMMA) cyclo-olefin polymers (COP), polydimethylsiloxane (PDMS), polyvinylpyrrolidone (PVP), polyethylene naphthalate (PEN), polyvinyl chloride (PVC), and a mixture thereof (Lu pg. 2, under “Results and Discussion”: “polyimide (PI)”).
In re claim 9, the proposed combination yields, wherein the graphene electrode comprises one to four layers (Lu, Fig. 1 depicts between one and four graphene electrode layers).
In re claim 10, the proposed combination does not yield, wherein the graphene electrode layer has a diameter of 30 to 150 microns.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the graphene electrode layer to have a diameter between 30 and 150 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
In re claim 11, the proposed combination yields, wherein the wiring layer is formed of one selected from the group consisting of gold (Au) (Lu, see pg. 2, under “Results and Discussion”), silver (Ag), copper (Cu), nickel (Ni), and iron (Fe).
In re claim 12, the proposed combination does not yield, wherein the wiring layer has a thickness of 30 to 60 nm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wiring layer to have a thickness between 30 and 60 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
In re claim 13, the proposed combination yields, wherein the insulation layer is formed of one selected from the group consisting of optical clean resin (OCR), optical clean adhesive (OCA), SU-8 (Lu Fig. 1c caption; “Results and Discussion”), and a mixture thereof.
In re claim 14, the proposed combination does not explicitly yield, wherein 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 the proposed combination 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, the proposed combination 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 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643), in view of Lu (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))), in view of Wang et al. (CN 108324274), in view of Byun et al. (KR 2012-0077585).
In re claim 3, the proposed combination does not yield, wherein 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 the proposed combination 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 .
In re 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, the proposed combination 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 the proposed combination and Byun as applied to claim 3.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643), in view of Lu (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))), in view of Wang et al. (CN 108324274), in view of Scheuermann (US 2010/0125319).
In re claim 4, the proposed combination does not yield, wherein 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 the proposed combination 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.
In re 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, the proposed combination 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 the proposed combination and Scheuermann as applied to claim 4.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Negi (US 2015/0305643), in view of Lu (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))), in view of Wang et al. (CN 108324274), in view of Khayrullaev et al. (US 2018/0317875).
In re claim 7, the proposed combination yields, the integrated circuit comprises a recording device and a stimulation device (para. 49, with reference to connectors 240, 242).
The proposed combination does not yield, 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 the proposed combinations integrated circuit to include these components in order to facilitate communications and wireless charging of the device, as suggested by Khayrullaev.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Anderson et al. (US 2012/0323288) discloses a neural interface (FIG. 5) that includes a contact portion (510), a connection portion (“interconnect”) and a transmitting/receiving portion (550). Anderson further discloses the contact portion including a polyimide flexible substrate fabricated with serpentine conductive traces [0033].
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
