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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/01/2024 has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-16, without traverse in the reply filed on 05/19/2026 is acknowledged.
Claim Objections
Claims 1-5, 10, and 16 are objected to because of the following informalities:
Claim 1, please amend “the proviso” to “[[the]] a proviso”.
Claim 2, please amend “said sensor comprises at least three electrodes” to “said at least two electrodes comprise[[s]] at least three electrodes”; “said electrodes” to “said at least three electrodes”; “one or more positively charged polymers” to “the one or more positively charged polymers”.
Claim 3, please amend “said electrodes” to “said at least three electrodes”; “one or more positively charged polymers” to “the one or more positively charged polymers”.
Claim 4, please amend “glassy carbon and mixtures thereof” to “the glassy carbon and mixtures thereof”; “comprises polystyrene sulfonate” to “comprises the polystyrene sulfonate”; “said electrodes” to “said at least three electrodes”; “one or more positively charged polymers” to “the one or more positively charged polymers”.
Claim 5, please amend “at least one electrode” to “at least one electrode of the at least two electrodes”.
Claim 10, please amend “said electrodes” to “said at least two electrodes”.
Claim 16, please amend “An article according to claim 15” to “[[An]] The article according to claim 15”.
Appropriate correction is required.
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.
Claims 1-16 are 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.
Regarding Claim 1, the limitation “a substrate having a surface area that comprises a material selected from the group consisting of conductive substrates and mixtures thereof” as it is unclear if “a material” is a single material or a composite material since “conductive substrates” is not a single material. Claims 2-16 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 1.
Regarding Claim 7, “said three electrodes” lack antecedent basis. Claims 8-9 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 7.
Regarding Claim 11, “said polybenzoate, polytrpytophan, polytyrosine, polyglutamate and polyaspartate” lack antecedent basis.
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.
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 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hardi (Enhancing the sensitivity of dopamine biosensor using PEDOT:PSS modified glassy carbon electrode. AIP Conf. Proc. 2021; 1-6) in view of Sakunpongpitiporn (Facile synthesis of highly conductive PEDOT:PSS via surfactant templates. RSC Advances 2019, 9, 6363-6378).
Regarding Claim 1, Hardi teaches a sensor (a three-electrode system connected to a potentiostat and associated Display/PC [Figure 1 on page 2]) comprising:
a) a substrate (electrode is made of glass carbon [fourth para. page 2]) having a surface area that comprises a material selected from the group consisting of conductive substrates and mixtures thereof (glassy carbon [fourth para. page 2], which is conductive);
b) a polymer (PEDOT:PSS [third para., page 2]) containing a plurality of aromatic functional groups and negatively charged functional groups (PEDOT contains aromatic functional groups and negatively charged functional groups); and
c) at least two electrodes (as illustrated in Figure 1 on page 2, CV setup contains three electrodes: a counter electrode, a working electrode, and a reference electrode).
Hardi is silent on with the proviso that said polymer comprises less than 33% by total polymer weight of one or more positively charged polymers.
Sakunpongpitiporn teaches facile synthesis of highly conductive PEDOT:PSS (abstract), and teaches said polymer comprises less than 33% by total polymer weight of one or more positively charged polymers (EDOT: PSS weight ratio is varied down to 0.5 g: 5.5 g [third para. col. 2, page 6364], which corresponds to a percentage of 0.5/6.0 = 8.3%).
Hardi and Sakunpongpitiporn are considered analogous art to the claimed invention because they are in the same field of conductive polymers for sensing. It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the weight ratio of PEDOT:PSS in Hardi to be 8.3%, as varying the weight ratio of PEDOT:PSS allows for control of the electrical conductivity (Sakunpongpitiporn, [Conclusion, page 6377]).
Regarding Claim 2, modified Hardi teaches the sensor of claim 1, and teaches said polymer comprises less than 10% by total polymer weight of one or more positively charged polymers (as outlined in the claim 1 rejection above, the weight ratio of PEDOT:PSS in Hardi is 8.3%).
Hardi teaches wherein said sensor comprises at least three electrodes (reference electrode, working electrode, and counter electrode [Figure 1, page 2]), at least one of said electrodes being in contact with said polymer (working electrode is electropolymerized with PEDOT:PSS (third para. page 2), said substrate comprises a material from the group consisting of carbon (electrode is glassy carbon [third para. page 2]), said polymer is selected from the group consisting of polystyrene sulfonate (working electrode has polymer PEDOT:PSS [third para. page 2]).
Regarding Claim 3, modified Hardi teaches the sensor of claim 2.
Hardi teaches said substrate comprises a material selected from the group consisting of glassy carbon (electrode is glassy carbon [third para. page 2]), said polymer comprises a material selected from the group consisting of polystyrene sulfonate (working electrode has polymer PEDOT:PSS [third para. page 2]), said electrodes comprise silver and platinum (platinum wire serves as the counter electrode; Ag/AgCl serves as the reference electrode [fourth para. page 2]).
Hardi is silent on said polymer comprises less than 5% by total polymer weight of the one or more positively charged polymers.
However, as the total polymer weight of the one or more positively charged polymers is intentionally made to have different weight ratios to vary the electrical conductivity of the polymer coating (Sakunpongpitiporn, [abstract page 6363, third para. col. 1 page 6367]), the property including total polymer weight of the one or more positively charged polymers affects the electrical conductivity of the sensor (Sakunpongpitiporn, [abstract, third para. col. 1, page 6367]). As electrical conductivity is a variable that can be modified, among others, by adjusting the property of the total polymer weight of the one or more positively charged polymers, the precise total polymer weight of the one or more positively charged polymers 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 total polymer weight of the one or more positively charged polymers 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 total polymer weight of the one or more positively charged polymers of modified Hardi to obtain a said polymer comprises less than 5% by total polymer weight of the one or more positively charged polymers, in order to choose the desired electrical conductivity of the electrode. “[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.).
Regarding Claim 4, modified Hardi teaches the sensor of Claim 3.
Hardi teaches said substrate comprises a material selected from the group consisting of glassy carbon (electrode is glassy carbon [third para. page 2]), said polymer comprises a material selected from the group consisting of polystyrene sulfonate (working electrode has polymer PEDOT:PSS [third para. page 2]), said polymer being disposed on said surface of said substrate (PEDOT:PSS is electropolymerized onto surface of glassy carbon electrode [third para. page 2]); said electrodes comprise silver and platinum (platinum wire serves as the counter electrode; Ag/AgCl serves as the reference electrode [fourth para. page 2]).
Hardi is silent on said polymer comprises less than 1% by total polymer weight of one or more positively charged polymers.
However, as the total polymer weight of the one or more positively charged polymers is intentionally made to have different weight ratios to vary the electrical conductivity of the polymer coating (Sakunpongpitiporn, [abstract, third para. col. 1, page 6367]), the property including total polymer weight of the one or more positively charged polymers affects the electrical conductivity of the sensor (Sakunpongpitiporn, [abstract, third para. col. 1, page 6367]). As electrical conductivity is a variable that can be modified, among others, by adjusting the property of the total polymer weight of the one or more positively charged polymers, the precise total polymer weight of the one or more positively charged polymers, 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 total polymer weight of the one or more positively charged polymers 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 total polymer weight of the one or more positively charged polymers of modified Hardi to obtain a polymer comprises less than 1% by total polymer weight of one or more positively charged polymers., in order to choose the desired electrical conductivity of the electrode. “[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.).
Regarding Claim 5, modified Hardi teaches the sensor of Claim 1.
Hardi teaches wherein at least one electrode comprises glassy carbon (working electrode comprises glassy carbon [fourth para. page 2]).
Regarding Claim 6, modified Hardi teaches the sensor of Claim 1.
Hardi teaches wherein said one or more positively charged polymers comprise poly(3,4-ethylenedioxythiophene) (PEDOT, which is poly(3,4-ethylenedioxythiophene); is used as the positively charged polymer [third para. page 2]).
Regarding Claim 7, modified Hardi teaches the sensor of Claim 1.
Hardi teaches wherein said three electrodes are a counter electrode, a working electrode, and a reference electrode (as illustrated in Figure 1, a counter electrode, a working electrode, and a reference electrode are used).
Regarding Claim 8, modified Hardi teaches the sensor of Claim 7.
Hardi teaches wherein said three electrodes are equidistant apart with working electrode being positioned between the reference electrode and counter electrode (as illustrated in Figure 1, all three electrodes are equidistant apart with the working electrode positioned in between the reference electrode and the counter electrode).
Regarding Claim 10, modified Hardi teaches the sensor of Claim 1.
Hardi teaches wherein the polymer is electropolymerized to at least one of said electrodes (PEDOT:PSS is electropolymerized on the glassy carbon electrode surface [third para. page 2]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hardi in view of Sakunpongpitiporn, as applied to claim 8 above, and in view of Julia (Development of an electrochemical dopamine sensor for monitoring the neurotransmitter release of human midbrain organoids on-chip Technische Universitat Wien 2023, 1-95).
Regarding Claim 9, modified Hardi teaches the sensor of Claim 8.
Hardi is silent on wherein said three electrodes are spaced equidistant apart in a triangular arrangement.
Julia teaches electrochemical detection of analytes including dopamine (first para. page 8), and teaches wherein said three electrodes are spaced equidistant apart in a triangular arrangement (as illustrated in Figures 1.4a and 1.4b on page 10, the WE, RE, and CE are spaced equidistant apart in a triangular arrangement when looking from a top down view of sensor).
Modified Hardi and Julia are considered analogous art to the claimed invention because they are in the same field of electrochemical detection of dopamine. It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the electrodes in modified Hardi to be spaced equidistant apart in a triangular arrangement, as taught by Julia, as using a triangular arrangement is suitable orientation for detection of analytes, such as dopamine (Julia, Figure 1.4 page 10 and Section 1.5, page 11]).
Claim 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hardi in view of Sakunpongpitiporn, as applied to claim 1 above, and in view of Hendricks (US 2011/0257504 A1).
Regarding Claim 12, modified Hardi teaches the sensor of Claim 1.
Hardi is silent on wherein the polymer is coated with a hydrogel.
Hendricks teaches bioelectrodes using conductive polymers (abstract), and teaches wherein the polymer is coated with a hydrogel (conducting polymer 50 is deposited directly onto the surface of one of the electrodes in Fig. 1B [para. 0057]; and a biocompatible hydrogel 120, such as chitosan [para. 0065], can be added for implantable electrodes [para. 0064]).
Modified Hardi and Hendricks are considered analogous art to the claimed invention because they are in the same field of electrochemical detection. It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the polymer in modified Hardi to be wherein the polymer is coated with a hydrogel, as taught by Hendricks, as a hydrogel can be added to serve as a scaffold for living cells and help with biocompatibility of the sensor device (Hendricks, [paras. 0045, 0064]).
Regarding Claim 13, modified Hardi teaches the sensor of Claim 12, wherein said hydrogel comprises chitosan (as outlined in the Claim 12 rejection above, Hendricks teaches the hydrogel may be chitosan (chitosan [para. 0065]).
Claim 14-16 is rejected under 35 U.S.C. 103 as being unpatentable over Hardi in view of Sakunpongpitiporn, as applied to claim 1 above, and in view of Nuh (A Novel Microfluidic-Based OMC-PEDOT-PSS Composite Electrochemical Sensor for Continuous Dopamine Monitoring Biosensors 2023, 13 (68), 1-14).
Regarding Claim 14, modified Hardi teaches the sensor of Claim 1.
Hardi is silent on said sensor being a chip.
Nuh teaches an electrochemical sensor for dopamine monitoring (abstract), and teaches the sensor being a chip (dopamine concentration is measured using a PEDOT:PSS biosensor on a chip [entire Section 2.3 Electrochemical Measurements, pages 3-4]; also illustrated in Figure 1, page 5).
Modified Hardi and Nuh are considered analogous art to the claimed invention because they are in the same field of electrochemical detection. It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to integrate the sensor in modified Hardi on a chip, as taught by Nuh, as integrated of an electrochemical sensor into a chip allows for continuous monitoring (Nuh, [second para. page 2]).
Regarding Claim 15, modified Hardi teaches comprising the sensor of Claim 1.
Hardi is silent on an article comprising the sensor of Claim 1.
Nuh teaches an article for sensors that detect small analytes, such as dopamine (a microfluidic-based PEDOT-PSS sensor platform [Figure 1, page 5]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to integrate the sensor in modified Hardi into an article, such as a microfluidic-based device, as taught by Nuh, as integrated of an electrochemical sensor into a chip allows for continuous monitoring (Nuh, [second para. page 2]).
Regarding Claim 16, modified Hardi teaches an article according to Claim 15, and said article being an analytical instrument (as outlined in the claim 15 rejection above, Nuh teaches dopamine sensors using polymers including PEDOT-PSS can be incorporated into a microfluidic-based chip device [Figure 1, page 5]).
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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