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 .
Status of the Claims
The amendment filed 12/19/2025 has been entered. Claims 1-2 have been amended. Claims 1-2 are currently pending and are examined herein.
Status of the Rejection
All 35 U.S.C. § 103 rejections from the previous office action are maintained and modified only in response to the amendments to the claims.
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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (“Durable soft neural micro-electrode coating by an electrochemical synthesis of PEDOT:PSS/graphene oxide composites,” 2019, Electrochimica Acta, vol. 313, pgs. 79-90), in view of Hardi et al. (“Amperometric Detection of Dopamine based on a Graphene Oxide/PEDOT:PSS Composite Electrode,” 2020, International Journal of Technology, vol. 11, pgs. 974-983), Benoudjit et al. (“Study of electropolymerized PEDOT:PSS transducers for application as electrochemical sensors in aqueous media,” 2018, Sensing and Bio-Sensing Research, vol. 17, pgs. 18-24), Raj et al. (“Enhanced organic photovoltaic properties via structural modifications in PEDOT:PSS due to graphene oxide doping,” 2016, Materials Research Bulletin, vol. 74, pgs. 346-352), and Castagnola et al. (“Morphology and conductivity of PEDOT layers produced by different electrochemical routes,” 2014, Synthetic Metals, vol. 189, pgs. 7-16).
Regarding claim 1, Lee teaches a method for preparing a biosensor (a PEDOT:PSS/graphene oxide-modified micro-electrode for biosensing [pg. 79, Abstract]), the method comprising:
a first step of preparing a solution comprising graphene oxide (GO), 3,4- ethylenedioxythiophene (EDOT), and polystyrene sulfonate (PSS) (EDOT, GO solution, and PSS dispersed in deionized water in Fig. 1(b) [pg. 81, col. 1, para. 4]); and
a second step of immersing, in the solution, electrodes having a reference electrode, a counter electrode, and a working electrode (Ag/AgCl reference electrode, Pt plate counter electrode, and gold working electrode are immersed in the dispersion for electrodeposition in Fig. 1(b) [pg. 81, col. 2, para. 2]), and applying a current to the working electrode to selectively deposit GO/PEDOT:PSS thereon (5 µA current is applied to the gold electrode to electrochemically deposit GO/PEDOT:PSS composite onto the electrode [pg. 81, col. 1, para. 5; pg. 81, col. 2, para. 2]).
Lee is silent to the following limitations: (1) the sensor being dopamine-sensitive; (2) the electrodes being formed on a support; (3) the solution comprising 0.0005 mol to 0.00125 mol of EDOT relative to 1 g of GO, and the molar ratio of EDOT and PSS being 1:10; (4) the second step is performed for 270 to 300 seconds; and (5) wherein a detection limit of the dopamine-sensitive sensor ranges from 0.01 µM to 0.1 µM.
Hardi teaches a dopamine-sensitive sensor, such that information on neurological conditions can be derived from detected dopamine levels [pg. 974, para. 2]. A GO/PEDOT:PSS film is coated on a working electrode via electro polymerization [pg. 974, Abstract], as GO/PEDOT:PSS composite exhibits high electrocatalytic behavior for dopamine oxidation [pg. 981, para. 3].
Lee and Hardi are both considered analogous to the claimed invention because they are in the same field of biosensors. 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 sensor in Lee by using it to detect dopamine, as taught in Hardi, since this would provide information on neurological conditions [pg. 974, para. 2 in Hardi]. Furthermore, Hardi teaches the claimed improvement as a known technique that is applicable to the base method in Lee. One skilled in the art could have applied the dopamine-sensing function in Hardi in the same way to the base device in Lee, as both sensors use a similar GO/PEDOT:PSS composite on the working electrode, yielding predictable results (MPEP 2143(I)(D)).
Benoudjit teaches a method for preparing a sensor (electrochemical sensor [pg. 18, Abstract]), the method comprising: a first step of preparing a solution comprising EDOT and polystyrene sulfonate (PSS) (solution consisting of NaPSS and EDOT [pg. 19, col. 2, para. 2-3]); and a second step of immersing, in the solution, electrodes having a reference electrode, a counter electrode, and a working electrode formed on a support (the sensor in Fig. 1 includes a reference electrode, counter electrode, and working electrode on a dark grey support [pg. 19, col. 2, para. 2]), and applying a current to the working electrode to selectively deposit PEDOT:PSS thereon (the electro polymerization deposition process shown in Fig. 1b includes immersing the sensor in the EPD solution and depositing PEDOT:PSS solely on the working electrode via an applied current [pg. 19, col. 2, Section 2.2; pg. 19, col. 2, para. 3]). Benoudjit further teaches that having the electrodes formed on a support improves sensor mobility and possible modes of application [pg. 18, col. 2, para. 1].
Lee and Benoudjit are both considered analogous to the claimed invention because they are in the same field of electrochemical sensors with electrodeposited PEDOT:PSS coatings. 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 three-electrode setup in Lee by forming the three electrodes on a support, as taught in Benoudjit, since this would improve sensor mobility ([pg. 18, col. 2, para. 1] in Benoudjit). Furthermore, Benoudjit teaches the claimed improvement as a known technique that is applicable to the base device in Lee. One skilled in the art could have applied the support for a reference electrode, counter electrode, and working electrode of Benoudjit in the same way to the base device in Lee, yielding predictable results (MPEP 2143(I)(D)).
Raj teaches a GO/PEDOT:PSS coating for improving the electrical conductivity and transport properties of a photovoltaic cell [pg. 346, Abstract]. The proportion of PEDOT:PSS relative to GO (and thus the proportion of EDOT relative to GO) was varied to test the GO dopant’s effect on the cell performance [pg. 347, col. 2, para. 3; pg. 348, col. 1, para. 3]. The addition of GO improved the conductivity of the cell up to a certain proportion, but further addition of GO then decreased conductivity [pg. 351, col. 1, para. 2].
As the conductivity of GO/PEDOT:PSS thin film is a variable that can be modified, among others, by adjusting the amount of EDOT relative to GO, as the addition of GO improves conductivity up to a certain proportion, but further addition of GO then decreases conductivity, as taught by Raj. The precise amount of EDOT relative to GO would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed amount of EDOT relative to GO cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the amount of EDOT relative to GO to be 0.0005 mol to 0.00125 mol of EDOT relative to 1 g of GO to obtain the desired conductivity as taught by Raj [pg. 351, col. 1, para. 2]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Castagnola teaches a method for electrochemically depositing PEDOT:PSS films on electrodes [pg. 8, col. 1, para. 2], wherein the method includes: a first step of preparing a solution comprising EDOT and PSS (electro polymerization starts with EDOT and NaPSS in aqueous solution [pg. 8, col. 1, para. 5]); and a second step of immersing, in the solution, electrodes having a reference electrode, a counter electrode, and a working electrode, and applying a current to the working electrode to selectively deposit PEDOT:PSS thereon (electro polymerization is conducted in a three-electrode cell configuration including a working electrode, a counter electrode, and a reference electrode, through an oxidation process by the application of a constant current [pg. 7, col. 2, para. 3]). Castagnola further teaches that the amount of NaPSS added to the aqueous solution affects the EDOT solubility in water [pg. 8, col. 2, para. 4], and the duration of the second step affects the homogeneity and conductivity of the deposited film [pg. 8, col. 2, paras. 5-6; pg. 9, col. 2, para. 2].
As the EDOT solubility is a variable that can be modified, among others, by adjusting the concentration of PSS in the electrochemical deposition solution, the precise molar ratio of EDOT and PSS in the solution would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed molar ratio of EDOT and PSS in the solution cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the molar ratio of EDOT and PSS in the solution in modified Lee to be 1:10 in order to obtain the desired EDOT solubility, as taught by Castagnola. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II).
Additionally, according to Faraday’s first law of electrolysis, the mass of a substance deposited at an electrode via an electrochemical reaction is directly proportional to the charge supplied to the electrode, such that the duration of electro polymerization also affects the thickness of the resultant layer on the working electrode.
As the homogeneity, conductivity, and thickness of the deposited film are variables that can be modified, among others, by adjusting the duration of electro polymerization, the precise duration of the second step would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed duration of the second step cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the duration of the second step in modified Lee to be 270 to 300 seconds in order to obtain the desired homogeneity and conductivity of the film, as taught by Castagnola, and the desired thickness of the film, as inferred from Faraday’s first law of electrolysis. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II).
The limitation “wherein a detection limit of the dopamine-sensitive sensor ranges from 0.01 µM to 0.1 µM” is an inherent property of the biosensor produced by the claimed method, and recognition of latent properties in the prior art does not render nonobvious an otherwise known invention (see MPEP 2145(II)). Because the combined method of modified Lee is substantially the same as the claimed method, the claimed detection limit property would necessarily be present in the biosensor produced by modified Lee.
Regarding claim 2, Lee teaches a dopamine-sensitive sensor (a PEDOT:PSS/graphene oxide-modified micro-electrode for biosensing [pg. 79, Abstract]. As evidenced by Hardi, GO/PEDOT:PSS composite exhibits high electrocatalytic behavior for dopamine oxidation [pg. 981, para. 3 in Hardi], such that the modified electrode is dopamine-sensitive) equipped with electrodes having a reference electrode, a counter electrode, and a working electrode (Ag/AgCl reference electrode, Pt plate counter electrode, and functionalized working electrode are used for electrochemical characterization [pg. 81, col. 2, para. 2]), the working electrode comprising a selectively deposited GO/PEDOT:PSS layer (the working electrode is a PEDOT:PSS/graphene oxide-modified micro-electrode [pg. 79, Abstract; pg. 81, col. 1, para. 5]).
Lee is silent to the following limitations: (1) wherein the electrodes are formed on a support; and (2) wherein a detection limit of the dopamine-sensitive sensor ranges from 0.01 µM to 0.1 µM.
Benoudjit teaches a PEDOT:PSS-modified sensor (electrochemical sensor [pg. 18, Abstract]) equipped with electrode having a reference electrode, a counter electrode, and a working electrode formed on a support (the sensor in Fig. 1 includes a reference electrode, counter electrode, and working electrode on a dark grey support [pg. 19, col. 2, para. 2]). Benoudjit further teaches that having the electrodes formed on a support improves sensor mobility and possible modes of application [pg. 18, col. 2, para. 1].
Lee and Benoudjit are both considered analogous to the claimed invention because they are in the same field of electrochemical sensors with electrodeposited PEDOT:PSS coatings. 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 three-electrode setup in Lee by forming the three electrodes on a support, as taught in Benoudjit, since this would improve sensor mobility ([pg. 18, col. 2, para. 1] in Benoudjit). Furthermore, Benoudjit teaches the claimed improvement as a known technique that is applicable to the base device in Lee. One skilled in the art could have applied the support for a reference electrode, counter electrode, and working electrode of Benoudjit in the same way to the base device in Lee, yielding predictable results (MPEP 2143(I)(D)).
The limitation “wherein a detection limit of the dopamine-sensitive sensor ranges from 0.01 µM to 0.1 µM” is a functional recitation. Apparatus claims cover what a device is, not what a device does (MPEP 2114(II)). A functional recitation 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. In the instant case, modified Lee teaches a sensor comprising substantially the same elements as that of the applicant, as evidenced above. It is contended that the electrochemical oxygen sensor of the prior art is capable of a detection limit ranging from 0.01 µM to 0.1 µM.
The limitations “wherein the dopamine-sensitive sensor is prepared by way of a first step of preparing a solution comprising graphene oxide (GO), 3,4-ethylenedioxythiophene (EDOT), and polystyrene sulfonate (PSS); and a second step of immersing, in the solution, electrodes having the reference electrode, the counter electrode, and the working electrode formed on the support, and applying a current to the working electrode to selectively deposit the GO/PEDOT:PSS thereon, wherein the solution comprises 0.0005 mol to 0.00125 mol of EDOT relative to 1 g of GO, and the molar ratio of EDOT and PSS is 1:10, wherein the second step is performed for 270 to 300 seconds” are considered product-by-process limitations. The determination of patentability is based upon the product or apparatus structure itself. Patentability does not depend on its method of production or formation. 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. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP § 2113).
In the alternative, as outlined in the rejection of claim 1 above, modified Lee teaches the process of making a sensor that encompasses the product-by-process limitations of claim 2.
Response to Arguments
Applicant's arguments, see Remarks pgs. 3-12, filed 12/19/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered and are not persuasive.
Applicant’s Argument #1:
Applicant argues on pgs. 6-7 that the recited mol number of EDOT relative to GO is not a result effective variable.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. One of ordinary skill in the art would have recognized from the teachings of Raj that the proportion of EDOT relative to GO would have an effect on the conductivity of a GO/PEDOT:PSS coating and optimized this proportion. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A).
Applicant’s Argument #2:
Applicant argues on pgs. 8-9 that there is no suggestion or motivation to modify or combine the teachings of Lee, Hardi, and Benoudjit with Raj and Castagnola, as Raj teaches a spin-coating method rather than electrodeposition, and Castagnola teaches a PEDOT:PSS film without the inclusion of GO.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive. Based on the teachings of Raj, one of ordinary skill in the art would have recognized that optimizing the proportion of PEDOT:PSS to GO in a coating composition would be routine, even with a different deposition method. Based on the teachings of Castagnola, one of ordinary skill in the art would have recognized that optimizing the proportion of PEDOT to PSS in a coating composition would be routine, even in the presence of a third element. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP § 2144.05(II)(A).
Applicant’s Argument #3:
Applicant argues on pgs. 10-11 that the improved sensitivity, signal linearity, and detection limit are unexpected results (see Table 1 in the instant specification).
Examiner’s Response #3:
Based on the above responses #1-#2, the claimed proportions of EDOT to GO and EDOT to PSS are considered result effective variables. The improvements indicated by the applicant in Table 1 are not considered greater than expected (e.g., the sensitivity of the 10:1 GO:(EDOT:PSS) ratio is of the same magnitude as the 2:1 and 5:1 data points; the linearity of the 1:1 GO:(EDOT:PSS) ratio is of the same magnitude as the 2:1 and 5:1 data points; and the detection limit of the 1:1 and 10:1 GO:(EDOT:PSS) ratio is of similar magnitude as the 2:1 and 5:1 data points).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795