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 05/20/2026 has been considered by the examiner.
Status of the Claims
Claims 49-57 and 59 have been amended. Claims 1-48 have been canceled. Claims 60-68 have been previously withdrawn. Claims 49-59 are currently examined herein.
Status of the Rejection
All claim objection, U.S.C. § 102, U.S.C. § 103, and U.S.C. § 112 rejections from the previous office action are withdrawn in view of the amendments.
New grounds of claim objection and rejection under 35 § U.S.C 103 are necessitated by the Applicant’s amendments.
Claim Objections
Claims 49 and 57 are objected to because of the following informalities:
Claim 49, please amend “a second plurality of electrodes connectable to at least one electronic device” to -- a second plurality of electrodes connectable to said at least one electronic device -- .
Claim 57, please amend “said second working electrode is” to -- said second working electrode of said second chip device is -- .
Appropriate correction is required.
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 49-50, 52-56 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Koul (US 2021/0270766 A1). O’Daly (US 5,391,272) is used as an evidence reference for claim 49.
Regarding Claim 49, Koul teaches a biosensor chip system (electrochemical-sensor system 100 in Figs. 1A and 1B [para. 0185]) usable for identifying and/or quantifying and/or monitoring at least one target in a sample (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]); the biosensor chip system comprises at least one of first chip device and at least one second chip device (electrochemical-sensor structures 104A and 104B in Fig. 13 serve as the at least one first chip device and the at least one second chip device, respectively [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. 0247]) connectable to at least one electronic device (PoC device 102 [para. 0246]); wherein at least one of said first plurality of electrodes is at least one working electrode (WE 128 [para. 0247]), said at least one 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 [paras. 0253, 0289]), wherein said at least one target binding site and/or said moiety specifically binds said at least one target or any component thereof (analyte that is targeted [para. 0253]; biomarker that electrochemical-structure 104A is specific for [para. 0254]), and wherein said first plurality of electrodes is configured for electrochemical impedance spectroscopy (electrochemical-sensor can detect using EIS [para. 0288]), whereby binding of said at least one target or any component thereof to said at least one target binding site and/or said moiety is detectable by an impedance change (detection of analyte binding signal can be based on electrochemical signals, including voltage and current [para. 0182]), 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 said 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 second plurality of electrodes is a second working electrode (WE 128 [para. 0247]), said second 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]).
Koul does not explicitly teach in all embodiments wherein said second plurality of electrodes is configured for electrochemical voltammetry or amperometry of said sample in a competitive assay in which a measured current is inversely indicative of an amount of said at least one target in said sample.
However, in a different embodiment, Koul teaches wherein said second plurality of electrodes is configured for electrochemical voltammetry or amperometry of said sample in a competitive assay (circuitry 144 may also be used for the amperometric type of measurements [para. 0196] or voltammetry [para. 0171] for samples including blood [para. 0178]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify said second plurality of electrodes of Koul to be configured for electrochemical voltammetry or amperometry of said sample in a competitive assay, as taught by Koul, as amperometric type of measurements are commonly used for glucose measurements [para. 0196]; the limitation “in which a measured current is inversely indicative of an amount of said at least one target in said sample” 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, as Koul’s working electrode can be widely modified to include monolayers, enzymes, or combinations thereof [para. 0189], and as evidenced by O’Daly, if an analyte is present in solution, the analyte may displace some of the analyte/enzyme bound on the working electrode so that the current is inverse to the concentration of analyte in solution (O’Daly, col. 9 lines 1-10). Thus, the biosensor chip system of modified Koul is capable of performing the claimed functions above.
Regarding Claim 50, modified Koul teaches the biosensor system according to claim 49.
Koul teaches 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 an electrode-carrying portion of a substrate (substrate 122 in Figs 4A-4D [para. 0199]) and define at least one measurement chamber encompassing said first and second plurality of 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), wherein the biosensor chip system comprises first and second chip devices (as illustrated in Fig. 13, strip receivers 256A with associated electrochemical-sensor structure 104A and strip receiver 256B with associated electrochemical-sensor structure 104B correspond to the first and second chip devices, respectively [para. 0246]), and wherein respective pluralities of electrodes are positioned in respective first and second separated measurement chambers (as each electrochemical-sensor structure 104 has a hydrophobic middle layer 176 to define the sampling region [para. 0201], the first and second plurality of electrodes have their respective first and second separated measurement chambers).
Regarding Claim 52, modified 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 least one of the first and the 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, modified 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 biosensor chip 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 said measurement chamber comprises at least three 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 a respective potentiostat circuitry 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), wherein said plurality of potentiostat circuitries comprises at least one first potentiostat circuitry associated with electrodes of said first chip device (first circuitry 142 [para. 0193-0194]) and configured for operating electrochemical impedance spectroscopy (EIS) (electrochemical-sensor 104A and associated circuitry may be configured for EIS [paras. 0196 and 0296-0297]), and at least one second potentiostat circuitry associated with electrodes of said second chip device (second circuitry 144 [para. 0193-0194]) and configured for operating at least one of voltammetry and amperometry measurement (circuitry 144 may also be used for amperometric type measurements [para. 0196]).
Regarding Claim 54, modified Koul teaches the biosensor chip system according to claim 49.
Koul teaches wherein said biosensor chip system comprises a plurality of one or more of the first chip devices and one or more of the second chip devices (multiple electrochemical-sensors 104A and 104B [para. 0246]; as illustrated in Fig. 23, multiple 104 disposable strips may be used), located in a plurality of separated measurement chambers (each electrochemical-sensor includes a sample region 134 [para. 0201]), the respective first and second 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 biosensor chip system 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 selectively transfer signals between the respective pluralities of electrodes to said potentiostat circuitry (in some embodiments, a multiplexer may be used [para. 0174]).
Regarding Claim 55, modified Koul teaches the biosensor chip system according to claim 49.
Koul teaches 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]);
the limitation “wherein at least one of:
said at least one small molecule compound is at least one toxin;
said at least one toxin is at least one cyanotoxin;
wherein said at least one cyanotoxin is at least one of: at least one cyclic peptide, at least one alkaloid and at least one lipopolysaccharide, or any combinations thereof; and
said at least one cyanotoxin is at least one cyclic peptide, said at least one cyclic peptide is at least one microcystin 9MC), or at least one nodularin (NOD)”
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 at least one small molecule compound (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 56, modified Koul teaches the biosensor chip system according to claim 55;
the limitation “wherein the at least one small molecule compound is at least one toxin; and wherein at least one of:
(a) said at least one toxin is at least one microcystin, said at least one 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 at least one 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, modified 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]).
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable by Koul, as applied to claim 50 above, in view of Anderson (US 2011/0201099 A1).
Regarding Claim 51, modified Koul teaches the biosensor chip system according to claim 50.
Koul teaches comprising at least one inlet for introducing said sample into the at least one measurement chamber (introductory channels 384, illustrated in Fig. 19 [para. 0283]), and at least one inlet filter for selectively passing said sample from said at least one inlet into said at least one measurement chamber (HP-PSC unit 386, to filter out unwanted interfering components of fluid 402 to sampling region 134 [para. 0286]).
Koul is silent on the biosensor chip system comprising an outlet formed in the packaging assembly and at least one outlet filter for selectively passing sample material from the at least one measurement chamber to said outlet.
Anderson teaches assay cartridges with a detection chamber (abstract), and teaches the biosensor chip system comprising an outlet (outlet port or drain, such as outlet 3626 [para. 0210]) formed in the packaging assembly (as illustrated in Fig. 36, outlet is included in biosensor assembly) and at least one outlet filter (outlet may include a filter element [para. 0210]) for selectively passing sample material from the at least one measurement chamber to said outlet (filter element prevents unwanted material, such as glass shards, from entering the cartridge fluidics [para. 0210]).
Koul and Anderson 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 biosensor chip system of modified Koul to include an outlet formed in the packaging assembly and at least one outlet filter for selectively passing sample material from the at least one measurement chamber to said outlet, as taught by Anderson, as using an outlet with associated filter would prevent unwanted material, such as glass, from entering the biosensor fluidics (Anderson, [para. 0210]).
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 said at least one target is at least one cyanotoxin, and wherein:
(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 second working electrode is connected directly or indirectly to said at least one cyanotoxin or a component thereof.
Santos teaches detection of microcystin-leucine-arginine (MC-LR) using an electrochemical sensing platform (abstract), and teaches wherein said at least one target is at least one cyanotoxin (target is microcystin-leucine arginine (MC-LR) [abstract]), (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 (MC-LR detection module is based on an indirect strategy using antibodies [first para. col. 2, page 3]; also illustrated in Fig. 1); (ii) said second working electrode is connected directly or indirectly to said at least one cyanotoxin or a component thereof (MC-LR detection module is based on an indirect strategy using antibodies contacted with MC-LR [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 biosensor chip system of modified Koul so that at least one target is at least one cyanotoxin, and wherein: (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 second working electrode is connected directly or indirectly to said at least one cyanotoxin or a component thereof, as taught by Santos, as a sensor with this setup allows for detection of toxins including MC-LR (Santos, [Conclusion, page 6]). Examiner notes that the limitation “wherein said at least one target is at least one cyanotoxin” further limits 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), this claim limitation has no patentable weight.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable by Koul, as applied to claim 49 above, in view of Harmony (Blood Glucose Monitoring System: User’s Guide, 2017, pages 1-68).
Regarding Claim 59, modified Koul teaches a kit (modular structure 480 in Fig. 23 [para. 0298]) comprising:
at least one biosensor chip system as defined in claim 49 (as outlined in the claim 49 rejection above, modified Koul teaches electrochemical-sensor system 100 which comprises an electrochemical-sensor system in Figs. 1A and 1B, which are disposable strips 104 [para. 0185]).
Koul is silent on and at least one of:
at least one control sample and/or control standard value;
instructions for use.
Harmony teaches a blood glucose monitoring system (abstract), and teaches (b) at least one control sample and/or control standard value (control solution is used to validate performance of blood glucose monitoring system [page 30]); (c) instructions for use (Harmony reference in its entirety is a manual for operating the blood glucose monitoring system [entire Harmony reference, pages 1-68]).
Koul and Harmony 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 biosensor chip system of modified Koul to include at least one control sample and/or control standard value and instructions for use, as taught by Harmony, as using a control solution is used to validate the performance of the biosensor system, and instructions for use allow a user to correctly operate the biosensor system (Harmony, [page 30]).
Response to Arguments
Applicant's arguments, see Remarks pgs. 16-20, filed 05/15/2026, with respect to the 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant’s Argument #1:
Applicant argues on pages 16-20 that for claims 49-56 and 58-59 that Koul discloses different compatible sensor strips/structures and a general PoC platform, but it does not disclose the claimed paired assay architecture: a first chip device comprising at least one working electrode connected directly or indirectly to at least one target binding site and/or moiety…whereby binding of said at least one target or any component thereof to said at least one target binding site and/or said moiety is detectable by an impedance change, together with a second chip device comprising a second working electrode connected directly or indirectly to said at least one target or any component thereof and configured for electrochemical voltammetry or amperometry analysis of said sample in a competitive assay in which a measured current is inversely indicative of an amount of said at least one target in said sample.
Koul does not disclose that 104A and 104B are a first chip device and a second chip device used together in a common biosensor chip system for the same target and utilizing different electrochemical techniques. Rather, Koul describes 104A and 104B as different types of electrochemical sensor structures that may be received by different strip receivers. Applicant has also amended claim 49 to recite “voltammetry/amperometry with current inversely indicative of target amount”, which is a specific working-electrode chemistry and assay format, and not a generic capability to measure current or voltage.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. Although Applicant argues that Koul does not use the claimed paired assay structure, Koul teaches an electrochemical sensor system 100 in Figs. 1A and 1B [para. 0185] with associated electrochemical sensor structures 104A and 104B. In addition, as the electrochemical sensor structures 104A and 104B can be attached to strip receivers 256A and 256B (Figure 13 [para. 0333]) and multiple test strips can be attached simultaneously (see Figure 23 with multiple disposable strips 104), the electrochemical sensor system of Koul reads on the at least one first chip device and the at least one second chip device of independent claim 49. In addition, Koul teaches the electrochemical sensors may also be used for the amperometric type of measurements [para. 0196] or voltammetry [para. 0171] for samples including blood [para. 0178], which is a competitive assay. The limitation “in which a measured current is inversely indicative of an amount of said at least one target in said sample” is a functional recitation, which is evidenced by O’Daly in the claim 49 rejection above.
Conclusion
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.
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
