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
Claims 1 and 3-15 are pending in the application and are the subject of this office action.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 3-5, 9-10, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 7-8 of copending Application No. 16/851,859 in view of Tabib-Azar et al (US 2021/0270771 Al; previously cited) and Bhat et al (US 2022/0050101 A1; previously cited).
All limitations of instant claim 1 are taught by reference claim 1, with the exception that reference claim 1 does not teach the functionalized sensing area functionalized with anti-SARS-CoV-2 spike protein antibody to detect SARS-CoV-2 antigen.
Tabib-Azar teaches a biosensor for virus detection of a selected virus within a sample volume (Abstract). The device comprises a sensor having a functionalized sensing area disposed between first and second electrodes, wherein the functionalization comprises immobilization of recognition molecules which specifically bind to the analyte of interest (i.e. test strip) (Par. 102: electrical sensor functionalized with molecular recognition molecules which specifically bind the target analyte; Par. 111-114, 139-140: functionalized channel area is disposed between source and drain electrodes). Tabib-Azar teaches that the biosensor may be used for the detection of SARS-CoV-2, and teaches that the molecular recognition groups used to detect the virus may be antibodies and may bind to the virus’s spiking proteins (Par. 102: sensor can be functionalized with molecular recognition groups that bind with a specific virus’s spiking proteins; Par. 104: molecular recognition group may be an antibody; Par. 4, 8, 139, Claim 9: virus detected may be SARS-CoV-2). Though all these teachings taken in combination suggest that the sensor comprise functionalization with an anti-SARS-CoV-2 spike protein antibody, Tabib-Azar does not explicitly teach this exact species of molecular recognition molecule.
Bhat discloses a biosensor comprising electrodes for the detection of SARS-CoV-2 (Abstract). Bhat further teaches that SARS-CoV-2 can be detected by a biosensor using anti-SARS-CoV-2 spike protein antibody (Par. 35, 82)
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 the invention of the reference claim such that the functionalized sensing area is functionalized with anti-SARAS-CoV-2 spike protein antibody to detect SARS-CoV-2 antigen, as taught by Tabib-Azar and Bhat. One would be motivated to make this modification because copending ‘859 is generic with respect to what the sensing area is functionalized with, and one would use the appropriate reagent, as taught by Tabib-Azar and Bhat, to provide for detection of a desired analyte (i.e. SARS-CoV-2 antigen), as taught by Tabib-Azar and Bhat. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Tabib-Azar teach FET based sensors for the detection of protein antigens using antibodies which specifically bind to those antigens.
Regarding instant claims 3, the reference claims do not specifically teach that the anti-SARS-CoV-2 antibody is bound to a gold sensing area surface.
Tabib-Azar further teaches that the sensing area surface may comprise gold, wherein the gold sensing surface is functionalized with an anti-SARS-CoV-2 antibody (Par. 102-105).
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 the reference claims to comprise the anti-SARS-CoV-2 anitbody bound to a gold sensing area surface, as taught by Tabib-Azar. One of ordinary skill in the art would be motivated to make this modification because one would be motivated to use an appropriate material for the sensing area surface of the device, and Tabib-Azar that gold is an appropriate material for a sensing area surface which is coupled to electrodes and functionalized with an antibody. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Tabib-Azar are directed to a sensing system comprising a functionalized sensing area.
Regarding instant claim 4, reference claim 4 further teaches that the antibody of the functionalized sensing area may be bound to the functionalized sensing area by a TGA binding agent.
Regarding instant claims 5 and 15, although neither the reference claims nor the cited references explicitly teach the disposable test strip comprising a second sensing area disposed between third and fourth electrodes, of the portable sensing and readout device configured to simultaneously or sequentially test a plurality of the disposable test strips, it would have been obvious to one of ordinary skill in the art to modify the reference claims to meet these limitations because they comprise a mere duplication of parts, wherein the course have help that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. As it applies to the instant claims, one would be motivated to make these modifications for the purpose of increasing the efficiency of running multiple tests or analyzing multiple sensors, and such duplication would be expected to yield predictable results with a reasonable expectation of success (i.e. these modifications would predictably result in increased testing capacity from either additional functionalized sensing areas or additional disposable test strips which can be analyzed simultaneous or sequentially).
Further regarding instant claim 15, the sensing unit analyzer taught by reference claim 1 is understood to inherently read on the portable sensing and readout device of instant claim 15, in that it is a device which may be coupled to the disposable test strips for testing, wherein a plurality of disposable test strips may be tested “sequentially” (i.e. testing a plurality of test strips one at a time, one after another would read on sequentially testing a plurality of test strips).
All additional limitations of instant claims 9 and 10 are taught by reference claims 7 and 8.
This is a provisional nonstatutory double patenting rejection.
Claims 5-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 16/851,859 in view of Tabib-Azar et al (US 2021/0270771 Al; previously cited) and Bhat et al (US 2022/0050101 A1; previously cited), as applied to claim 1 above, and further in view of Byrne et al (US 2018/0299403 A1; previously cited).
Regarding instant claims 5-6 and 8, the reference claims in view of Tabib-Azar and Bhat teach the sensing system of claim 1, as described above. Neither the reference claims nor Tabib-Azar specifically teaches the system wherein the second sensing area is a reference sensing area.
Byrne teaches a medical sensing system wherein the disposable test strip comprises a second sensing area disposed between third and fourth electrodes (Par. 131; Fig. 8), wherein Fig. 8 shows two functionalized sensing areas 510 each disposed between two different electrodes 506, and also shows a reference sensing area 502 disposed between two additional electrodes.
It would have been obvious to one of ordinary skill in the art to have modified the invention of the reference claims in view of Tabib-Azar and Bhat to comprise a second sensing area disposed between third and fourth electrodes, wherein the second sensing area may be either an additional functionalized sensing area, or a reference sensing area, as taught by Byrne. One would be motivated to make this combination because Byrne teaches the advantages of both multiple functionalized sensing areas on a sensor and a reference sensing area on the sensor (Par. 133; Par. 5). One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Byrne are directed to a sensor comprising a functionalized sensing area disposed between two electrodes.
Regarding instant claim 7, the reference claims in view of Tabib-Azar, Bhat, and Byrne teach the system of claim 6 as described above. Reference claim 4 further teaches that the sensing area may be functionalized with a thiol functional group (i.e. TGA). The reference claims do not specifically teach the system wherein the reference sensing area is functionalized with a thiol functional group and without -COOH, -OH, or -NH2.
Regarding instant claim 7, Tabib-Azar teaches a sensor comprising a gold surface functionalized with molecular recognition molecules such as antibodies. Tabib-Azar further teaches that the gold surface can be functionalized using any suitable functionalization technique, such as the use of thiol groups and alkylthiols (Par. 105). Both the reference claims and Tabib-Azar tech the attachment of antibodies to a sensing surface using thiol chemistry, and the substitution of the TGA taught by the reference claims for other thiol reagents such as the alkylthiols taught by Tabib-Azar amounts to simple substitution of known elements to achieve predictable results. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Tabib-Azar disclose antibodies which are thiol-linked to a functionalized sensing surface.
It would have been obvious to one of ordinary skill in the art to have modified the invention of the reference claims in view of Tabib-Azar, Bhat, and Byrne such that the reference sensing area is functionalized with a thiol functional group and without -COOH, -OH, or -NH2, as taught by Tabib-Azar.
This is a provisional nonstatutory double patenting rejection.
Claims 11-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-14 of copending Application No. 16/851,859 in view of Tabib-Azar et al (US 2021/0270771 Al; previously cited) and Bhat et al (US 2022/0050101 A1; previously cited) as applied to claim 1 above, and further in view of Yang et al (Rapid detection of cardiac troponin I detection in physiological environment using antibody immobilized gate pulsed AIGaN/GaN high electron mobility transistor structures. Appl. Phys. Lett. 111, 202104 (November 2017); IDS entered).
Regarding instant claim 11, the reference claims in view of Tabib-Azar and Bhat teach the system of claim 1, as described above. Reference claim 11 further teaches the medical sensing system wherein the first and second electrodes are Au based metal electrodes disposed on a base structure (i.e. substrate) (wherein a Ni/Au based metal electrode as recited in reference claim 11 is understood to read on a Au based metal electrode as recited in instant claim 11).
The reference claims do not explicitly teach the system wherein the electrodes are covered by a protective cover comprising a sample deposit opening.
Yang teaches a medical sensing system (Abstract) comprising a single use disposable test strip (Fig. 1). The test strip comprises a functionalized area coated with antibodies, and a gate electrode connected to the functional area (Pg. 2, Col. 1, Par. 2). Yang further discloses that a pulsed voltage is applied between the reactive electrode and the source (Pg. 2, Col. 1, Par. 2). Yang teaches a portable sensing and readout device (Pg. 3, Col. 2, Par. 2).
Yang further teaches the system wherein the first and second electrodes are Au based metal electrodes disposed on a base structure and covered by a protective cover comprising a sample deposit opening (Fig. 1; Pg. 3, Col. 1, last Par. – Col. 2, first Par.)
It would have been obvious to one of ordinary skill in the art to have modified the system of the reference claims in view of Tabib-Azar and Bhat to further include a protective cover comprising a sample deposit opening, as taught by Yang. One of ordinary skill in the art would be motivated to make this modification for the purpose of providing protection to the electrodes and preventing contamination of reagents and sample within the test strip. One of ordinary skill in the art would have a reasonable expectation of success in making this modification because both the reference claims and Yang are directed to test strips comprising metal electrodes and a functionalized sensing area.
All additional limitations of instant claims 12-14 are taught by reference claims 12-14.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 1 and 3-15 are rejected as described above, but appear to be free of the prior art.
The closest prior art is Yang et al (Rapid detection of cardiac troponin I detection in physiological environment using antibody immobilized gate pulsed AIGaN/GaN high electron mobility transistor structures. Appl. Phys. Lett. 111, 202104 (November 2017); IDS entered) in view of Byrne et al (US 2018/0299403 A1), Tabib-Azar et al (US 2021/0270771 Al; previously cited) and Bhat et al (US 2022/0050101 A1; previously cited) as described in the non-final office action of 19 March 2025. However, this combination of prior art fails to establish a prima facie case of obviousness for the instant claims, for the reasons described in Applicant’s remarks filed 19 June 2025.
Namely, Yang teaches a test strip comprising a gate electrode area electrically connected to a nearby area functionalized with antibody, as seen in Fig. 1.
Yang further teaches a pulse generator capable of producing a step waveform function for both gate (or cover glass active) and drain electrodes, thereby reading on “pulse generation circuitry configured to generate synchronized gate and drain pulse, the first electrode of the disposable sensing unit electrically coupled to a gate pulse output of the pulse generation circuitry” (Pg. 2, Col. 2, Par. 2-Pg. 3, Col. 1, Par. 1). Yang teaches the drain electrode as a part of a FET device, e.g. HEMT (Pg. 1, Col. 1, Par. 2: FETs functionalized with antibodies or aptamer layers in the gate region; Pg. 2, Col. 2, Par. : teaching that the HEMTs were biased with 2V on the drain), thereby reading on “a transistor having a drain electrically controlled by a drain pulse output of the pulse generation circuity”. Yang teaches a gate of the FET device, e.g. HEMT is electrically connected to the reference area/unfunctionalized Au electrode, thereby reading on “a gate electrically coupled to the second electrode of the disposable sensing unit (Fig. 1, Pg. 3, Col. 2, Par. 2).
Yang does not explicitly teach that the sensing system comprises a functionalized area disposed between first and second electrodes.
Byrne discloses a device comprising an active sensor (i.e. test strip) having a functionalized sensing area disposed between first and second electrodes (Par. 7; Fig. 2). Moreover, the device is not reused, and is therefore considered disposable (Par. 31). Byrne further teaches a gate electrode configured to apply a gate bias to the channel (Par. 71). The gate electrode can be beneath, on a side, or adjacent to the channel (Par. 71). The sensing system taught by Byrne is used to detect analytes based on a change in the electrical properties of the FET (Par. 7).
Tabib-Azar and Bhat disclose a biosensors functionalized with anti-SARS-CoV-2 spike protein antibodies.
However, as applicant indicates in their remarks, while Byrne and Tabib-Azar disclose transistors (FET) with the functionalized area disposed on the transistor between the source and drain electrodes of the transistor, neither Byrne nor Tabib-Azar teach or suggest functionalizing an area between a gate electrode and a reference electrode, wherein the reference electrode is electrically coupled to the gate of the transistor, as disclosed by Yang.
While Yang discloses a functionalized area disposed on a gate electrode spaced apart from a second reference electrode connected to the gate of a separate HEMT, Byrne and Tabib-Azar disclose transistors with the functionalized area disposed on the transistor between the source and drain electrodes with the gate electrode separated from the functionalized area. Further, it is not obvious to modify Yan in view of the teachings of Byrne and Tabib-Azar to meet the instant claim. Modification of the sensor to comprise the functionalized area between the drain and source electrodes (as taught by Byrne and Tabib-Azar) would mean that the functionalized area would no longer be in direct electrical connection to the gate of the transistor or in the path of the gate pulse signal. As such, the configuration of the sensor of Yang is structurally and functionally distinct from the configuration of the sensors taught by Byrne and Tabib-Azar, such that substitution of the configuration of Yang with the configuration of Byrne or Tabib-Azar would not yield predictable results or a reasonable expectation of success.
Moreover, applicant persuasively argues, such a modification would no longer satisfy the claim language which requires that the first electrode of the disposable test strip be electrically couple to a gate pulse output, because the source electrode of the transistor taught by Byrne and Tabib-Azar is not equivalent to or directly substitutable for the gate electrode taught by Yang.
Response to Arguments
Applicant’s arguments filed 15 January 2026 have been fully considered.
Regarding the double patenting rejection over copending application 16/851,859, applicant argues that the reference claims are patentably distinct from the instant claim because the independent reference claim recites “a functionalized sensing area disposed between first and second electrodes on the substrate without a transistor or transistor component between the first and second electrodes, the functionalized sensing area functionalized with an anti B-2 transferrin antibody”. This argument is not persuasive because the instant claims do not require a transistor or transistor component between the first and second electrodes, therefore the negative limitation in the reference claim does not prevent the reference claim from reading on the instant claim, and does not patentably distinguish one from the other. The double patenting rejection is maintained.
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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/ELLIS FOLLETT LUSI/Examiner, Art Unit 1677
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677