DETAILED ACTION
In application filed on 08/12/2022, Claims 1-19 are pending. The claim set submitted on11/12/2025 is considered because this is the most recent claim set with some primary amendments. Claims 14-19 are considered in the current office 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 10/28/2022 and 02/13/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of Group II, Claims 14-19 in the reply filed on 11/12/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on11/12/2025.
Group II, Claims 14-19 are considered on the merits below.
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 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.
Claims 14, 16-17 and 19 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Lin et al. (US20180368743A1).
Regarding Claim 14, Lin teaches a device for use in detecting one or more drugs and/or drug metabolites of interest in a liquid sample, the device comprising:
(a) a graphene field effect transistor (See Abstract… The microdevice can include a field effect transistor comprising a substrate, a gate electrode, and a microfluidic channel including graphene; Further See Para 0032 for the affinity nanosensor), the graphene field effect transistor (See Abstract… The microdevice can include a field effect transistor comprising a substrate, a gate electrode, and a microfluidic channel including graphene; See Para 0045…the nanosensor can have a FET configuration) comprising a first well (referred to as enrichment chamber [Para 0046]); and
(b) a first aptamer (referred to as any of the aptamers [Para 0046]), the first aptamer (referred to as any of the aptamers [Para 0046]) being coupled (‘immobilized’) to the graphene field effect transistor (See Abstract… The microdevice can include a field effect transistor comprising a substrate, a gate electrode, and a microfluidic channel including graphene; Further See Para 0032 for the affinity nanosensor; or microfluidic aptasensor [Para 0046]; See Abstract…The microdevice can also include at least one aptamer functionalized on a surface of the graphene) in the first well (See Para 0046…The enrichment chamber can include one or more microbeads. Aptamers can be immobilized on the surface of the microbeads, where a microfluidic aptasensor including an enrichment chamber), the first aptamer (referred to as any of the aptamers [Para 0046]) being selective (See Abstract…The at least one aptamer can be adapted for binding to the target analyte) for a first drug or drug metabolite of interest (See Para 0179…In various embodiments, the analytes can be other metabolites…; See Para 0364…In such methods, the aptamers of the device can be designed to bind to the drug found in the bodily fluid).
Regarding Claim 16, Lin teaches that the first aptamer (referred to as any of the aptamers [Para 0046]) is coupled (‘immobilized’) to the graphene field effect transistor (See Abstract… The microdevice can include a field effect transistor comprising a substrate, a gate electrode, and a microfluidic channel including graphene; Further See Para 0032 for the affinity nanosensor; or microfluidic aptasensor [Para 0046]; See Abstract…The microdevice can also include at least one aptamer functionalized on a surface of the graphene) using a linker molecule (See Para 0051… the aptamer can be functionalized to the surface of graphene via a linker).
Regarding Claim 17, Lin teaches that the linker molecule (See Para 0051… the aptamer can be functionalized to the surface of graphene via a linker) is pyrenebutyric acid N-hydroxysuccunumide ester (See Para 0051… linker can be a pyrene-terminated agent (e.g., 1-pyrenebutanoic acid succinimidyl ester)).
Regarding Claim 19, Lin teaches a system (referred to as a microdevice for monitoring a target analyte [Abstract]) for detecting one or more drug and/or drug metabolites (See Para 0179…In various embodiments, the analytes can be other metabolites…; See Para 0364…In such methods, the aptamers of the device can be designed to bind to the drug found in the bodily fluid.) in a liquid sample (See Para 0023-0024… sample or bodily fluid; See Para 0032…sample solution), the system (referred to as a microdevice for monitoring a target analyte [Abstract]) comprising the device of claim 14 (See Claim 14 rejection for the device of Claim 14),
a voltage sweep generator (referred to as digital sourcemeters [Para 0544]); See Para 0544…For the GFET-based electrical measurements, both the drain and gate voltages were supplied by digital sourcemeters ) for applying a voltage sweep (See Para 0384… sweeping voltage of about 0-1 V can be applied to the gate electrode (1515) forming a gate voltage (Vgs) through a sample solution) to the graphene field effect transistor (See Para 0384…the nanosensor can be configured as a FET in that the graphene (1501)), and a reader/analyzer (See Para 0185…wireless interface can include a capacitance digital converter coupled with the microdevice and adapted to produce a digital signal representing a measurement of the target analyte in the bodily fluid of the subject…) for measuring the resultant resistance (See Para 0050… The electrical conductance through the graphene can be measured by measuring the drain current at a fixed drain voltage; See Para 0188… the FET sensing element with graphene as the conducting channel has an electric resistance of about 0.1 kΩ-about 3 kΩ…) and comparing the resultant resistance to appropriate standards (See Para 0117…FIG. 48 illustrates a plot showing the measurements with standard mixtures of free aptamer at 25 nM and sample AVP at varying concentrations (1-100 nM), thereby teaching “comparing the resultant resistance to appropriate standards”.)
In addition, Claim 19 recites a system having a voltage sweep generator and recites how the system functions. Claim 19 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20180368743A1) as applied to claim 14 above, and further in view of Tey et al. (US20110237000A1).
Regarding Claim 15, Lin does not teach that the first aptamer is selective for a drug or drug metabolite selected from the group consisting of oxycodone, noroxycodone, fentanyl, norfentanyl, morphine, and 2-ethylidene-1,5-dimethyl-3,3-diphenyl-pyrrolidine.
In the analogous art of a method of detecting the presence or amount of an analyte, Tey teaches that the first aptamer (See Para 0076… the analyte-binding molecule can also be a non-proteinaceous receptor, such as for example a nucleic acid based molecule, such as an Aptamer or Spiegelmer (Aptamer made of L-ribonucleotides).) is selective (‘binding’) for a drug or drug metabolite selected from the group consisting of oxycodone, noroxycodone, fentanyl, norfentanyl, morphine, and 2-ethylidene-1,5-dimethyl-3,3-diphenyl-pyrrolidine (See Para 0086…the analyte may be a drug molecule such as morphine…).
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 device of Lin, as taught by Tey, for the benefit of detecting analyte molecules which may be neutral, i.e. do not bear a net charge, have no dipole moment, or any other analyte molecule that, in the absence of a suitable carrier, would only induce a small electrical signal, where the analyte may be a drug molecule (Tey, Para 0085-0086), allowing for the need for development of a simple and sensitive method that also allows detection of other types of analytes (Tey, Para 0006).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20180368743A1) as applied to claim 14 above, and further in view of Gudibande et al. (US20210212603A1).
Regarding Claim 18, Lin does not teach that the graphene field effect transistor further comprises a second well and wherein the device further comprises a second aptamer, the second aptamer being coupled to the graphene field effect transistor in the second well, the second aptamer being selective for a second drug or drug metabolite of interest, the second drug or drug metabolite of interest being different than the first drug or drug metabolite of interest.
In the analogous art of sensing systems that may comprise a replaceable sensor element, a readout system and, optionally, a mount to adhere the device to a patient or to a connected device, Gudibande teaches that the graphene field effect transistor (See Para 0003… Disposable or replaceable sensors; See Para 0011… the plurality of modular sensors comprises at least one graphene-based sensor; See Para 0121… A sensor element of the present disclosure may comprise a field effect transistor comprising a drain electrode; a source electrode; an electrically insulating substrate; a nanoscale material layer) further comprises a second well (referred to as any of the multiplexed sensor elements [Para 0117; Fig. 5B, refs 105-1, 105-2 or 105-3) and wherein the device further comprises a second aptamer (See Para 0124…sensor elements 105) can then later functionalized with selective bio chemical molecules. For example, the graphene layer may be functionalized with a receptor layer deposited on the nanoscale material (e.g. graphene) layer. The receptor layer may comprise receptors targeting a target analyte. In some embodiments, the receptors may comprise…aptamers), the second aptamer being coupled to the graphene field effect transistor (See Para 0124…graphene layer being functionalized with the receptor layers comprising aptamers) in the second well (referred to as any of the multiplexed sensor elements [Para 0117; Fig. 5B, refs 105-1, 105-2 or 105-3), the second aptamer (See Para 0124… The receptor layer may comprise receptors targeting a target analyte, where the receptors are aptamers) being selective for a second drug or drug metabolite of interest (See Para 0124…the target analyte comprises…a drug molecule, a metabolite), the second drug or drug metabolite of interest being different than the first drug or drug metabolite of interest (See Para 0117…the different multiplexed configurations permit a plurality of different target analytes to be detected from a sample of the subject collected on the wearable device when the subject is wearing the device; See Para 0124…the target analyte comprises…a drug molecule, a metabolite; See Para 0016… the different multiplexed configurations permit a plurality of different target analytes to be detected from a sample of the subject collected on the device when the subject is wearing the device or in proximity to the device.).
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 device of Lin to incorporate that that the graphene field effect transistor further comprises a second well and wherein the device further comprises a second aptamer, the second aptamer being coupled to the graphene field effect transistor in the second well, the second aptamer being selective for a second drug or drug metabolite of interest, the second drug or drug metabolite of interest being different than the first drug or drug metabolite of interest, as taught by Gudibande for the benefit of having the different multiplexed configurations permit a plurality of different target analytes to be detected from a sample of the subject collected on the wearable device when the subject is wearing the device (Gudibande, Para 0029), allowing for the provision of disposable or replaceable sensors that may be utilized in monitoring physiological signals with high sensitivity and/or specificity (Gudibande, Para 0003).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Perlin et al. (US20200248182A1) teaches aptamers having a G-quadruplex structure that bind specifically to the most commonly used azole-class antifungal drugs, biosensors that comprise those aptamers, and invitro methods for determining the level of one of those drugs utilizing those aptamers or biosensors.
Jain (US20180120254A1) teaches an array of biosensors diagnosing biomarkers device and a drug delivery vehicle system including a plurality of bio
sensor arrays for diagnosing biomarkers concentrations, and a delivery vehicle dispensing drug , a electronic interface , a plurality of algorithms to relate biomarker concentrations and drug dispensed , wherein biosensors in said plurality of biosensor arrays are constructed from quantum dot field effect transistors , and wherein one or more layers of cladded quantum dots are assembled in the channel , gate , and channel and gate regions of FETs , and wherein quantum dots are functionalized by DNA aptamers , antisense oligoneuclotides ( ASOs ) , and DNAs , to sense biomarkers concentrations comprising at least one of proteins , miRNAs , and genes , and wherein the concentrations of biomarkers changes and their values change the magnitude of drain current as a function of time , and wherein the drain current signal is processed by an electronic interface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797