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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February6 has been entered.
Status of Objections and Rejections
The rejection of claim(s) 3-4 is/are obviated by Applicant’s cancellation.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 and 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (S. Kumar, Reduced graphene oxide modified smart conducting paper for cancer biosensor, Biosensors and Bioelectronics, 2015(73), pp. 114-22) in view of Mao (H.Y. Mao, Manipulating the electronic and chemical properties of graphene via molecular functionalization, Progress in Surface Science 2013(88), pp. 132-159), and further in view of Galagan (US 2021/0259585), and further in view of Ye (CN 112051314 A, machine translation for citation).
Regarding claim 1, Kumar teaches an electrochemical sensor ([Abstract]: a paper based sensor) for simultaneous detection of dopamine and serotonin (the preamble is a statement with regard to the intended use and not further limiting in so far as the structure of the product is concerned. MPEP § 2111.02(II)) comprising a working electrode ([Abstract]: paper electrode) containing:
a gold (Au) thin film substrate ([Abstract]: incorporation of RGO into the conducting paper, which is an alternative to the conventional electrodes, such as gold);
a layer comprising reduced graphene oxide (rGO);
the layer comprising poly(3,4-ethylenedioxythiophene):poly(4-styrenesulfonate) (PEDOT:PSS) ([Abstract]: poly(3,4-ehtylenedioxythiophene):poly(styrenesulfonate) (PEDOT:PSS) and reduced graphene oxide (RGO) composite; Fig. 2(C)-(F): PEDOT:PSS/RGO composite).
Kumar does not disclose the layer is composed of one rGO layer and the other layer comprising PEDOT:PSS or the layer comprising PEDOT:PSS being disposed on the rGO layer.
However, Mao teaches functionalization of graphene and its derivates, e.g., GO and rGO (p. 134, para. 4-5). As an example, CVD graphene film is one of the best candidates for graphene-based transparent and conducting electrode (p. 146, section 3.3.2). A uniform PEDOT:PSS layer is spined coated on graphene electrode functionalized with PBASE (Fig. 10(a); bridging para. of pp. 146-147). In addition to CVD graphene, rGO has also been used for ITO-free OPVs due to the advantages of large-scale production, low-cost, and good solution processability (p. 145, last para.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar by separating the layer of PEDOT:PSS/RGO composite into two layers with the layer comprising rGO being disposed on the layer comprising PEDOT:PSS as taught by Mao because it would provide a uniform PEDOT:PSS layer and significantly increase the electrical conductivity of graphene without sacrificing its high optical transparency (p. 147, para. 1). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Kumar and Mao do not disclose the working electrode containing a layer comprising Nafion disposed on the layer comprising PEDOT:PSS.
However, Galagan teaches a biosensor electrode printed from a conducting polymer, such as PEDOT:PSS and a protective coating (¶175). The protective coating is a polymer that reduces or prevents the non-specific interaction or interference of different molecules in the biological sample and prevent negatively charged interferences from reaching the sensor surface (¶175), and exemplary polymer of the protective coating is Nafion (¶175).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar and Mao by incorporating Nafion as a protective coating on the electrode as taught by Galagan because the Nafion protective coating would reduce or prevent the non-specific interaction or interference of different molecules in the biological sample by preventing negatively charged interferences from reaching the sensor surface(¶175). As a result, the combined Kumar, Mao, and Galagan would necessarily result in the protective coating of Nafion being the top layer of the layers, i.e., on the layer comprising PEDOT:PSS. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
The designation “obtained by electrochemically reducing, at pH 4.01, a graphene oxide deposited on the Au thin film substrate by cyclic voltammetry (CV) in a voltage range of – 1.5 V to 0 V” is product-by-process limitation. Even 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). MPEP 2113(I).
Kumar does not disclose wherein the rGO has a Raman D-band to G-band intensity ratio (ID/IG) of 1.43.
However, Ye teaches electrochemical materials in application of electrochemical sensing (p. 1, para. 1). The ratio of ID/IG obtained by Raman spectroscopy (p. 10, section 4) for reduced graphene oxide prepared by chemical methods is usually 1.2 ~1.5 (p. 11, para. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar by adjusting the Raman D-band to G-band intensity ratio (ID/IG) as claimed because it is within the typical range for reduced graphene oxide and well-known in the art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I).
Regarding claim 2, Kumar teaches wherein the reduced graphene oxide is one in which a graphene oxide deposited on a gold (Au) thin film ([Abstract]: incorporation of RGO into the conducting paper, which is an alternative to the conventional electrodes, such as gold).
The designation “electrochemically reduced” is product-by-process limitation. Even 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). MPEP 2113(I).
Regarding claims 6-7, the designations “wherein the sensor is one capable of simultaneously detecting dopamine and serotonin selectively by lowering the signal of an interfering substance having a negative charge” and “wherein the interfering substance is any one or more selected from the group consisting of ascorbic acid (AA), uric acid (UA), glucose, epinephrine (EP), norepinephrine (NE), and combinations thereof” in claim 7 are deemed to be functional limitations in apparatus claims. 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). Here, Kumar in view of Mao, Galagan, and Ye teaches all structural limitations of the presently claimed electrochemical sensor which is capable of simultaneously detecting dopamine and serotonin selectively by lowering the signal of an interfering substance having a negative charge, e.g., AA, UA, EP, NE. Further, Galagan teaches Nafion protective coating that reduces or prevents the non-specific interaction or interference of different molecules in the biological sample by preventing negatively charged interferences from reaching the sensor surface (¶175).
Regarding claim 8, Kumar teaches a kit, the kit comprising the sensor of claim 1 (as described in claim 1).
The preamble “for simultaneous detection of dopamine and serotonin” is deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. In article claims, a claimed intended use 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. MPEP § 2111.02(II). The apparatus as taught by Kumar in view of Mao, Galagan, and Ye is identical to the presently claimed kit, i.e., an electrochemical sensor, and would therefore would have the ability to perform the use recited in the claim.
Claim(s) 5 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar in view of Mao, Galagan, and Ye, and further in view of Mirica (US 2021/0262970).
Regarding claim 5, Kumar, Mao, Galagan, and Ye disclose all limitations of claim 1. Kumar further discloses wherein the sensor further comprises: a counter electrode including platinum (Pt) (p. 115, col. 2, para. 2: platinum as auxiliary electrode); and a reference electrode including a silver/silver chloride (Ag/AgCl) (p. 115, col. 2, para. 2: Ag/AgCl as the reference electrode). Kumar, Mao, and Galagan do not disclose the counter electrode including a platinum (Pt) wire.
However, Mirica teaches a three-electrode system including a glassy carbon working electrode, a reference electrode: Ag/AgCl electrode and a platinum wire counter electrode for cyclic voltammetry experiments (¶194).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar, Mao, Galagan, and Ye by substituting the platinum counter electrode with a platinum wire as taught by Mirica because the platinum wire is a suitable counter electrode for an electrochemical detection. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 9, Kumar in view of Mao, Galagan, Ye, and Mirica discloses an electrode system, the electrode system comprising the sensor of claim 5 (as described in claim 5).
The preamble “neural” is deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. In article claims, a claimed intended use 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. MPEP § 2111.02(II). The apparatus as taught by Kumar in view of Mao, Galagan, Ye, and Mirica is identical to the presently claimed electrode system and would therefore would have the ability to perform as a neural electrode system.
The preamble “for simultaneous detection of dopamine and serotonin” is deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. In article claims, a claimed intended use 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. MPEP § 2111.02(II). The apparatus as taught by Kumar in view of Mao, Galagan, Ye, and Mirica is identical to the presently claimed electrode system that is capable of functioning as a neural electrode system and would therefore would have the ability to perform the use recited in the claim.
Regarding claim 10, Kumar, Mao, Galagan, Ye, and Mirica disclose all limitation of claim 9. Kumar, Mao, Ye, and Mirica fail to teach wherein the system is one in which pluralities of counter electrodes and reference electrodes paired with a plurality of working electrodes are disposed in proximity.
However, Galagan teaches sensors include an array of sets of three electrodes (¶184). Each sensor includes a working electrode 2a disposed on the support layer 6, and a counter electrode 2b, and reference electrode 2c spaced from the working electrode 2a and disposed on the support (Fig. 6B-C: electrode test strip 1; ¶137).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar, Mao, Ye, and Mirica by incorporating pluralities of counter electrodes and reference electrodes paired with a plurality of working electrodes disposed in proximity as taught by Galagan because the array of sets of three electrodes is a suitable configuration of electrochemical electrode system. Further, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. MPEP 2144.04(VI)(B).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar in view of Mao, Galagan, Ye, and Mirica, and further in view of Corrigan III (US 2022/0073964).
Regarding claim 11, Kumar, Mao, Galagan, Ye, and Mirica disclose all limitation of claim 9, but fail to teach wherein the system is one in which single counter electrode and reference electrode that share a plurality of working electrodes. Since Galagan teaches a three-electrode electrochemical sensor, including the working electrode, the reference electrode, and the counter electrodes, they are disposed to be spaced apart from each other (Galagan, Fig. 6B).
However, Corrigan III teaches a multimodal sensor bundle including multiple electrochemical sensors for nucleic acid detection ([Abstract]). The sensor bundle may include an array (e.g., three in Fig. 5) of electrochemical sensors 122 (¶24), and each electrode sensor includes a working electrode, a counter electrode, and a reference electrode (¶¶25, 32). In other examples, the reference electrode can be a common electrode for an array of electrochemical sensors (¶32). Also, the counter-electrode can be a common counter-electrode (a shared counter electrode) for multiple working electrodes (¶32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kumar, Mao, Galagan, Ye, and Mirica by utilizing a common or shared reference electrode and a common or shared counter electrode as taught by Corrigan III because it provides a suitable configuration of electrochemical electrode system, and simplifies the electrode configuration. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues there is no teaching or suggestion in Kumar, Mao, and Galagan of the recited four-layer architecture: Au thin film [Wingdings font/0xE0] rGO [Wingdings font/0xE0] PEDOT:PSS [Wingdings font/0xE0] Nafion (Response, p. 7, para. 6) by attacking the references individually (p. 7, para. 4-5) and, therefore, do not address adequately the rejection the Examiner presents in the record. See In re Keller, 642 F.2d 413, 426 (CCPA 1981) (“[O]ne cannot show non-obviousness by attacking references individually where, as here, the rejections are based on combinations of references.”), 425 (“[T]he test [for obviousness] is what the combined teachings of the references would have suggested to those of ordinary skill in the art.”); see also In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986); and KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[T]he [obviousness] analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”). In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning by extensive restructuring (p. 7, para. 6), it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Further, the fact that the examiner has combined an excessive number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
Applicant’s arguments that the claimed layered architecture provides clear, well-separated oxidation peaks for dopamine and serotonin even in the presence of high concentrations of ascorbic acid and uric acid (p. 8, para. 2) does not amount unexpected improvement to support non-obviousness. Applicant further argues the Office should consider secondary consideration of the claimed invention based on “long-felt but unsolved need” in neurochemical monitoring and achieved limits of detection and anti-interference properties (p. 8, para. 4). These arguments are unpersuasive because there is no evidence supporting “unexpected” outcomes rather than different and foreseeable superior outcomes from the prior art. Here, Applicant does not show failure of others for such a combination or discouragement, e.g., “teaching away” of the combination in the prior art.
The amended claim 1 recites “the rGO has a Raman D-band to G-band intensity ration (ID/IG) of 1.43” (p. 10, para. 4) has been addressed by citing the prior art, Ye, and thus Applicant’s argument is moot. Further, the designations “obtained by electrochemically reducing, at pH 4.01” and “a graphene oxide deposited on the Au thin film substrate by cyclic voltammetry (CV) in a voltage range of – 1.5 V to 0V” are product-by-process limitations, and do not add patentable weight to the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
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/C. SUN/Primary Examiner, Art Unit 1795
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