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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/06/2024, 05/06/2024, and 09/04/2025 have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 49-59 in the reply filed on 12/10/2025 is acknowledged.
Claim Objections
Claims 49, 51, 53- 56, and 58-59 are objected to because of the following informalities:
Claim 49, please amend “the system comprises” to “the biosensor chip system comprises”; “indirectly to said target or any component” to “indirectly to said at least one target or any component”; “said electrodes” to “said first plurality of electrodes” in line 5; “said target binding site and/or moiety” to “said at least one target binding site and/or said moiety”; “said electrodes” to “said second plurality of electrodes” for the second chip device in line 13.
Claim 51, please amend “said inlet “said at least one inlet”.
Claim 53, please amend “said system” to “said biosensor chip system”; “each of said measurement chambers” to “each measurement chamber[[s]]”.
Claim 54, please amend “said system” to “said biosensor chip system”; “configured to selective transfer signals” to “configured to selectively transfer signals”; “one or more first chip devices and one or more second chip devices” to “one or more of the first chip devices and one or more of the second chip devices”; “the respective pluralities of electrodes” to “the respective first and second pluralities of electrodes”; “reference electrode” to “reference electrodes”.
Claim 55, please amend “said toxin” to “said at least one toxin”; “said cyanotoxin” to “said at least one cyanotoxin”; “said cyclic peptide” to “said at least one cyclic peptide”; “at least one microcystin (MC), and at least one nodularin (NOD)” to “at least one microcystin (MC), [[and]] or at least one nodularin (NOD)”.
Claim 56, please amend “wherein small molecule” to “wherein the at least one small molecule”; “said toxin” to “said at least one toxin”; “said microcystin” to “said at least one microcystin”.
Claim 58, please amend “the system” to “the biosensor chip system”.
Claim 59, please amend Claim 59 to remove the duplicate limitations already recited in Claim 49.
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 49-59 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 49, the limitation “said working electrode” for the said second chip device is unclear if the “said working electrode” refers to the working electrode in the first chip device or the second chip device. Claims 50-59 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 49.
Regarding Claim 50, the limitation “the substrate” lacks antecedent basis. In addition, “said electrodes” is unclear if it refers to the first plurality of electrodes, the second plurality of electrodes, or both the first and second plurality of electrodes. Claims 51-52 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 50.
Regarding Claim 51, the limitation “measurement chamber” is unclear as to if “the measurement chamber” refers to the first measurement chamber or the second measurement chamber.
Regarding Claim 52, the limitations “the measurement chamber” and “said measurement chamber” are unclear if they refer to the first measurement chamber or the second measurement chamber.
Regarding Claim 53, the limitation “the plurality of electrodes” and “the at least three electrodes” lacks antecedent basis, and it is unclear if “the plurality of electrodes” refers to the first plurality of electrodes or the second plurality of electrodes, or other plurality of electrodes.
Regarding Claim 54, the limitation “the device” is unclear if “the device” refers to a plurality of one or more first chip devices, a plurality of one or more second chip devices, or both a plurality of one or more first chip devices and a plurality of one or more second chip devices.
Regarding Claim 57, the limitation “said at least one working electrode” lacks antecedent basis since claim 49 recites “a working electrode”; “said at least one cyanotoxin” also lacks antecedent basis.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 49-56 and 58-59 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Koul (US 2021/0270766 A1).
Regarding Claim 49, Koul teaches a biosensor chip system (electrochemical-sensor structure 100 in Figs. 1A and 1B [para. 0185]); the biosensor chip system comprises at least one of first and at least one second chip devices (electrochemical-sensor structures 104A and 104B in Fig. 13 [para. 0246]); wherein:
said first chip device comprises a first plurality of electrodes (electrochemical-sensor structure 104A includes three electrodes RE 124, CE 126, and WE 128 [para. 0246]) connectable to at least one electronic device (PoC device 102 [para. 0246]); wherein at least one of said electrodes is a working electrode (WE 128 [para. 0246]), said working electrode is connected directly or indirectly to at least one target binding site and/or moiety (electrochemical-sensor structure 104 may include a biomarker or antibody on the electrochemical-sensor structure [para. 0253]), wherein said target binding site and/or moiety specifically binds said at least one target or any component thereof (analyte that is targeted [para. 0253]; biomarker that electrochemical-structure 104 is specific for [para. 0254]), and
said second chip device (electrochemical-sensor structure 104B in Fig. 14 [para. 0247]) comprises:
a second plurality of electrodes (electrochemical-sensor structure 104B includes three electrodes RE 124, CE 126, and WE 128 in Fig. 14 [para. 0247]) connectable to at least one electronic device (as illustrated in Fig. 14, electrochemical-sensor system 100 includes a strip insert 254 [para. 0246]); wherein at least one of said electrodes is a working electrode (WE 128 [para. 0247]), said working electrode is connected directly or indirectly to said target or any component thereof (electrochemical-sensor structure 104 may include a biomarker or antibody on the electrochemical-sensor structure [para. 0253]);
the limitations the biosensor chip system is “usable for identifying and/or quantifying and/or monitoring at least one target in a sample”, first plurality of electrodes is “configured for electrochemical impedance spectroscopy (EIS) analysis of said sample”, and said plurality of electrodes is “configured for electrochemical voltammetry or amperometry analysis of said sample” are functional recitations. 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, electrochemical-sensor structure 100 is used for monitoring an analyte, such as proteins or small molecules in a sample of a patient’s bodily fluid [para. 0167], first plurality of electrodes is configured for electrochemical impedance spectroscopy (EIS) analysis of said sample (electrochemical-sensor can detect using EIS [paras. 0280, 0288]), and second plurality of electrodes can be configured for voltammetry or amperometry analysis of said sample (electrochemical techniques, such as cyclic voltammetry and amperometry may be used [para. 0280]). Thus, the electrochemical-sensor structure 100 and associated electrochemical-sensor structures 104A and 104B are capable of performing the claimed functions above.
Regarding Claim 50, Koul teaches the biosensor system according to claim 49, further comprising a packaging assembly (as illustrated in Figs 4A-4D, electrochemical-sensors 104 can include a hydrophobic middle layer 176 and protection layer 180 [para. 0201]) configured to sealably enclose said electrodes portion of the substrate (substrate 122 in Figs 4A-4D [para. 0199]) and define at least one measurement chamber encompassing said electrodes (hydrophobic middle layer 176 covers a distal portion of electrochemical-sensor structure 104, which includes the electrodes, and defines sampling region 134 to form a chamber [para. 0201]; illustrated in Figs 4A-4D).
Regarding Claim 51, Koul teaches the biosensor chip system according to claim 50.
Koul teaches comprising at least one inlet for introducing said sample into said measurement chamber (introductory channels 384, illustrated in Fig. 19 [para. 0283]), and at least one inlet filter for selectively passing said sample from said inlet into said measurement chamber (HP-PSC unit 386, to filter out unwanted interfering components of fluid 402 to sampling region 134 [para. 0286]).
Regarding Claim 52, Koul teaches the biosensor chip system according to claim 50.
Koul teaches wherein at least one of:
(c) said at least one electronic device comprises one or more potentiostat circuitries connected at said one of first and second chip devices (as illustrated in Fig. 3, PoC Device 102 can comprise one or more potentiostat circuitries connected using electrochemical disposable strips 104; also generally detailed in [paras. 0052-0053, 0174, 0178]).
Regarding Claim 53, Koul teaches the biosensor chip system according to claim 49.
Koul teaches wherein said at least one electronic device comprises a plurality of potentiostat circuitries (electrochemical-sensor structures are connected via circuitry 144 [para. 0196], such as potentiostat first circuitry 142 and second circuitry 144 in Fig. 3A [paras. 0193-0194]), said system comprising a plurality of measurement chambers (each electrochemical-sensor 104 has a sampling region 134 [para. 0201]; note that sampling region 134 is a chamber, as illustrated in Figs 4B and 4D) comprising at least one first measurement chamber associated with said first chip device (sampling region 134 associated with electrochemical-sensor 104A) and at least one second measurement chamber associated with said second chip device (sampling region 134 associated with electrochemical-sensor 104B), each of said measurement chambers comprises at least three of the plurality of electrodes defining a working electrode, a reference electrode, and a counter electrode (electrochemical-sensor structures 104A and 104B includes three electrodes RE 124, CE 126, and WE 128 in Fig. 14 [para. 0247]), and is associated with respective potentiostat circuitries electrically connected to the at least three electrodes of its respective measurement chamber (electrochemical-sensor structures 104 are electrically connected to potentiostat, see for example Fig. 23).
Regarding Claim 54, Koul teaches the biosensor chip system according to claim 49, wherein said system comprises a plurality of one or more first chip devices and one or more second chip devices (multiple electrochemical-sensors 104A and 104B [para. 0246]), located in a plurality of separated measurement chambers (each electrochemical-sensor includes a sample region 134 [para. 0201]), the respective pluralities of electrodes comprises a plurality of working electrodes, reference electrodes, and counter electrodes (electrochemical-sensor structures 104A and 104B includes three electrodes RE 124, CE 126, and WE 128 in Fig. 14 [para. 0247]), and wherein the device comprises a potentiostat circuitry (potentiostat circuitry [para. 0171, 0174], such as potentiostat first circuitry 142 and second circuitry 144 in Fig. 3A [paras. 0193-0194] to connect individual test strips [para. 0299]) and a multiplexer device configured to selective transfer signals between the respective pluralities of electrode to said potentiostat circuitry (in some embodiments, a multiplexer may be used [para. 0174]).
Regarding Claim 55, Koul teaches the biosensor chip system according to claim 49, wherein said target is at least one small molecule compound (target analyte can be NT-pro-BNP, Cardiac troponin, and/or the like [para. 0180]).
Regarding Claim 56, Koul teaches the biosensor chip system according to claim 55;
the limitation “small molecule compound is at least one toxin; and wherein at least one of:
(a) said toxin is at least one microcystin, said microcystin is at least one of Microcystin-leucine-arginine (MC-LR), Microcystin-arginine-arginine (MC-RR), Microcystin-tyrosine-arginine (MC-YR), and Microcystin-leucine-alanine (MC-LA), and any combination, derivative and variants thereof; and
(b) wherein said microcystin is Microcystin-LR (MC-LR), or any derivatives and variants thereof” further limit the sample but fail to further limit the apparatus. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." See MPEP 2115. Since the claims further limit the sample (material worked upon) but fails to limit the biosensor chip system (by a structure being claimed), the limitations of the claim have no patentable weight.
Regarding Claim 58, Koul teaches the biosensor chip system according to claim 49, wherein said sample is a biological sample (sample can be a patient’s bodily fluid [para. 0035]).
Regarding Claim 59, Koul teaches a kit (modular structure 480 in Fig. 23 [para. 0298]) comprising:
(a) at least one biosensor chip system as defined in claim 49 (modular structure 480 comprises an electrochemical-sensor system in Figs. 1A and 1B, which are disposable strips 104 [para. 0185]) usable for identifying and/or quantifying and/or monitoring at least one target in a sample; the system comprises at least one of first and at least one second chip devices (electrochemical-sensor structures 104A and 104B in Fig. 13 [para. 0246]); wherein:
said first chip device comprises a first plurality of electrodes (electrochemical-sensor structure 104A includes three electrodes RE 124, CE 126, and WE 128 [para. 0246]) connectable to at least one electronic device (PoC device 102 [para. 0246]); wherein at least one of said electrodes is a working electrode (WE 128 [para. 0246]), said working electrode is connected directly or indirectly to at least one target binding site and/or moiety (electrochemical-sensor structure 104 may include a biomarker or antibody on the electrochemical-sensor structure [para. 0253]), wherein said target binding site and/or moiety specifically binds said at least one target or any component thereof (in some embodiments, the electrochemical-sensor may be used for analyzing a sample with detectable biomarkers [para. 0260]), and wherein said first plurality of electrodes is configured for electrochemical impedance spectroscopy (EIS) analysis of said sample (electrochemical-sensor can detect using EIS [paras. 0280, 0288]); and
said second chip device (electrochemical-sensor structure 104B in Fig. 14 [para. 0247]) comprises:
a second plurality of electrodes (electrochemical-sensor structure 104B includes three electrodes RE 124, CE 126, and WE 128 in Fig. 14 [para. 0247]) connectable to at least one electronic device (as illustrated in Fig. 14, electrochemical-sensor system 100 includes a strip insert 254 [para. 0246]); wherein at least one of said electrodes is a working electrode (WE 128 [para. 0247]), said working electrode is connected directly or indirectly to said target or any component thereof (electrochemical-sensor structure 104 may include a biomarker or antibody on the electrochemical-sensor structure [para. 0253]), and wherein said plurality of electrodes is configured for electrochemical voltammetry or amperometry analysis of said sample (electrochemical techniques, such as cyclic voltammetry and amperometry may be used [para. 0280]).
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.
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable by Koul, as applied to claim 49 above, in view of Santos (Portable sensing system based on electrochemical impedance spectroscopy for the simultaneous quantification of free and total microcystin-LR in freshwaters Biosensors and Bioelectronics 2019; 142, 1-7).
Regarding Claim 57, Koul teaches the biosensor chip system according to claim 49.
Koul is silent on wherein at least one of:
(i) said at least one working electrode of said first chip device is connected directly or indirectly to at least one antibody that specifically binds said at least one cyanotoxin; and
(ii) said at least one working electrode of said second chip device is connected directly or indirectly to said at least one cyanotoxin.
Santos teaches detection of microcystin-leucine-arginine (MC-LR) using an electrochemical sensing platform (abstract), and teaches said at least one working electrode of said second chip device is connected directly or indirectly to said at least one cyanotoxin (MC-LR detection module is based on an indirect strategy using antibodies [first para. col. 2, page 3]; also illustrated in Fig. 1).
Koul and Santos are considered analogous art to the claimed inventions because they are in the same field of biosensors. 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 working electrode of the second electrochemical-sensor 104B of modified Koul by functionalizing the surface with MC-LR so that said at least one working electrode of said second chip device is connected directly or indirectly to said at least one cyanotoxin, as taught by Santos, as a sensor with this setup allows for detection of toxins including MC-LR (Santos, [Conclusion, page 6]).
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795