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 .
Claims Status
Claims 1-19 are pending and are examined.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim limitation “back-end system configured to detect and compare the surface resistance” in claim 1 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “system” coupled with functional language “to detect and compare the surface resistance” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “system” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 1 has/have been interpreted to cover “an NFC antenna” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., [0066] in the instant application US Pub 2024/0069014).
Claim Objections
Claim 1 is objected to because of the following informalities: “Phosphate-buffered saline” should be “phosphate-buffered saline”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1, 2, 3, 4, 5, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nawana (US Pub 2021/0293816), in view of Lee (US Pub 2018/0128823).
Regarding Claim 1, Nawana teaches an integrated device for analyzing a breath sample, comprising: a front-end system comprising a detection region and a control region, wherein the detection region and the control region have similar structures, a back-end system; and a microfluidic channel arranged to cover the detection region so as to allow the interdigital electrode of the detection region to be exposed to the breath sample, wherein: the graphene film of the detection region has a surface resistance higher than that of the graphene film of the control region when the detection region is exposed to a selected virus; and the back-end system is configured to detect and compare the surface resistance of the graphene films of the detection region and the control region for determining whether the selected virus is present in the breath sample ([0086] FIGS. 4A, 4B, and 4C schematically depicts another embodiment of a sensor 700 according to the present teachings. The sensor 700 includes a graphene layer 701 that is disposed on an underlying substrate 702, e.g., a semiconductor substrate, and is functionalized with an anti-SARS-CoV-2 antibody 703. The remainder of the surface of the graphene layer 701 (i.e., the surface areas not functionalized with the antibodies) can be passivated via a passivation layer 708. In this embodiment, a silicon oxide layer 706 separates the graphene layer from the underlying substrate. A source electrode (S) and a drain electrode (D) are electrically coupled to the graphene layer to allow measuring a change in one or more electrical parameters of the functionalized graphene layer in response to interaction of the functionalized graphene layer with a sample.).
wherein the microfluidic channel comprises a plurality of gas channels and a trapping chamber configured to hold pre-injected Phosphate-buffered saline (PBS) for defining a gas-liquid interface ([0103] By way of example, FIG. 9A schematically depicts such a microfluidic channel 900 that has a serpentine shape extending from an inlet port 901 to an outlet port 902, where the serpentine shape of the microfluidic channel provides passive mixing of the sample as the sample passes through the channel. FIG. 9B shows another microfluidic channel 920 that has a spiral shape extending from an inlet port 921 to an outlet port 922, where the serpentine shape of the channel provides passive mixing of a sample passing through it). ([0109] FIG. 11 schematically depicts a sensor 1200 according to an embodiment, which includes a plurality of graphene-based sensing elements 1201, 1202, 1203, 1204, 1205, 1206, 1207, and 1208 according to the present teachings. In this embodiment, the sensing element 1201 includes a graphene layer that is functionalized with an antibody that exhibits specific binding to the N protein of the SARS-CoV-2 virus, and the sensing element 1205 includes a graphene layer that is functionalized with an antibody that exhibits specific binding to the S viral protein. These sensing elements include ports 1201b and 1205b, which are configured to receive a liquid sample generated by using a diluent (e.g., a phosphate buffer solution) to extract viruses, if any, from a nasal swab used to collect a mucosal sample, and a saliva sample, from an individual).
Nawana, in Fig. 11, shows multiple paths (channels; [0109] These sensing elements include ports 1201b and 1205b (ports to path/channel), which are configured to receive a liquid sample generated by using a diluent (e.g., a phosphate buffer solution) with multiple inlets for sensing of the sample. [0113] The sensing elements 1204 and 1208 includes ports 1204b and 1208b (ports to path/channel) for receiving a sample.)
The examiner notes that the term “gas” does not modify channels as it is directed to intended use of the channel. A channel would be capable of having liquid, gas, or a fluid. The examiner notes that the limitation “configured to hold pre-injected Phosphate-buffered saline (PBS) for defining a gas-liquid interface” is directed to intended use of the device. PBS is not required as part of the claimed device since it is not positively recited.
wherein the plurality of gas channels comprise plural gas inlets and a gas outlet, which are arranged outside and around the trapping chamber, wherein the gas outlet is positioned proximate to a gas side of the gas-liquid interface, and the plural gas inlets are positioned proximate to a liquid side of the gas-liquid interface ([0103] By way of example, FIG. 9A schematically depicts such a microfluidic channel 900 that has a serpentine shape extending from an inlet port 901 to an outlet port 902, where the serpentine shape of the microfluidic channel provides passive mixing of the sample as the sample passes through the channel. FIG. 9B shows another microfluidic channel 920 that has a spiral shape extending from an inlet port 921 to an outlet port 922, where the serpentine shape of the channel provides passive mixing of a sample passing through it. The examiner notes that the term “gas” is directed to intended use of the device as the sample is not limited to a gas since gas is not part of the claimed device).
Nawana is silent to each comprising an interdigital electrode and a graphene film.
Lee teaches in the related art of [0016] Biomarker detection using interdigitated electrodes in the microchannel of the biochip is also utilized in the present disclosure. The disease biomarker may be diagnosed using the nanocircuit in the microfluidic environment. The interdigitated electrodes may be of different conducting materials. [0017] The interdigitated electrodes are implemented in the microfluidic environment and specified shaped micro channels. The interdigitated electrodes are used to measure the capacitance change when the AG/AB interaction with biomarkers but the electrodes can also be used for other electrical measurements and variations. [0084] When the bio fluid flows through microchannel, the disease specific antigens in the bio-fluid interacts with the antibodies which are immobilized on the surface of electrodes and forms the antigen-antibody complex. The capacitance change due to antigen antibody interaction is measured between the interdigitated electrodes. This change in capacitance provides information of existence disease antigens concentration in the bio-fluid. The capacitance change due to antigen antibody interaction is measured between the interdigitated electrodes. This change in capacitance provides information of existence disease antigens concentration in the bio-fluid.
Therefore, 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 electrodes in the device of Nawana, to be interdigited, as taught by Lee, to allow for increased sensitivity.
Regarding Claim 2, Nawana teaches the integrated device of claim 1, wherein: the microfluidic channel comprises a plurality of gas channels and a trapping chamber (the examiner notes “pre-injected PBS” and “breath sample” are directed to intended use of the device. The chamber would be capable of holding PBS. [0103] By way of example, FIG. 9A schematically depicts such a microfluidic channel 900 that has a serpentine shape extending from an inlet port 901 to an outlet port 902, where the serpentine shape of the microfluidic channel provides passive mixing of the sample as the sample passes through the channel. FIG. 9B shows another microfluidic channel 920 that has a spiral shape extending from an inlet port 921 to an outlet port 922, where the serpentine shape of the channel provides passive mixing of a sample passing through it. [0109] FIG. 11 schematically depicts a sensor 1200 according to an embodiment, which includes a plurality of graphene-based sensing elements 1201, 1202, 1203, 1204, 1205, 1206, 1207, and 1208 according to the present teachings. In this embodiment, the sensing element 1201 includes a graphene layer that is functionalized with an antibody that exhibits specific binding to the N protein of the SARS-CoV-2 virus, and the sensing element 1205 includes a graphene layer that is functionalized with an antibody that exhibits specific binding to the S viral protein. These sensing elements include ports 1201b and 1205b, which are configured to receive a liquid sample generated by using a diluent (e.g., a phosphate buffer solution) to extract viruses, if any, from a nasal swab used to collect a mucosal sample, and a saliva sample, from an individual.).
Nawana is silent to a trapping chamber holding pre-injected Phosphate-buffered saline (PBS) for defining a gas-liquid interface; the graphene film and the interdigital electrode of the detection region are placed inside the trapping chamber and immersed in the pre-injected PBS; and the breath sample passes through the gas-liquid interface for capturing the selected virus in the pre-injected PBS.
Nawana teaches [0067] The linker modified graphene layer can then be incubated with the antibody of interest in a buffer solution (e.g., NaCO.sub.3-NaHCO.sub.3 buffer solution (pH 9)) at a selected temperature and for a selected duration (e.g., 7-10 hours at 4 C), followed by rinsing with deionized (DI) water and phosphate buffered solution (PBS).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the PBS to the chamber at the face of the membrane in the device of modified Nawana to allow for physiological conditions for a biological sample to be tested or analyzed.
Regarding Claim 3, modified Nawana teaches the integrated device of claim 2, wherein the pre-injected PBS is injected with a molecular linker and a spike-binding antibody, wherein the spike-binding antibody is arranged to capture the spike protein of SARS-CoV-2, and the surface resistance of the graphene film of the detection region is increased when exposed to the selected virus with the SARS-CoV-2 linked to the graphene film by the molecular linker ([0064] As shown schematically in FIG. 1B, a variety of linker molecules 18 can be employed for coupling the anti-SARS-CoV-2 antibodies to the underlying graphene layer. By way of example, in some embodiments, 1-pyrenebutonic acid succinimidyl ester is employed as a linker to facilitate the coupling of the anti-SARS-CoV-2 antibodies to the underlying graphene layer. In this embodiment, the plurality of anti-SARS-CoV-2 antibodies can cover a fraction of, or the entire, surface of the graphene layer. [0067] The linker modified graphene layer can then be incubated with the antibody of interest in a buffer solution (e.g., NaCO.sub.3-NaHCO.sub.3 buffer solution (pH 9)) at a selected temperature and for a selected duration (e.g., 7-10 hours at 4 C), followed by rinsing with deionized (DI) water and phosphate buffered solution (PBS).)
Regarding Claim 5, Nawana teaches the integrated device of claim 2, wherein the molecular linker comprises cross-linking collagen polymers using 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC) and N-hydroxysuccinimide (NHS) (([0064] As shown schematically in FIG. 1B, a variety of linker molecules 18 can be employed for coupling the anti-SARS-CoV-2 antibodies to the underlying graphene layer. By way of example, in some embodiments, 1-pyrenebutonic acid succinimidyl ester is employed as a linker to facilitate the coupling of the anti-SARS-CoV-2 antibodies to the underlying graphene layer. In this embodiment, the plurality of anti-SARS-CoV-2 antibodies can cover a fraction of, or the entire, surface of the graphene layer. [0067] The linker modified graphene layer can then be incubated with the antibody of interest in a buffer solution (e.g., NaCO.sub.3-NaHCO.sub.3 buffer solution (pH 9)) at a selected temperature and for a selected duration (e.g., 7-10 hours at 4 C), followed by rinsing with deionized (DI) water and phosphate buffered solution (PBS).)
Regarding Claim 6, modified Nawana teaches the integrated device of claim 5, wherein a first end of the EDC/NHS combines with the graphene film, and a second end of the EDC/NHS combines with the spike-binding antibody ([0064] As shown schematically in FIG. 1B, a variety of linker molecules 18 can be employed for coupling the anti-SARS-CoV-2 antibodies to the underlying graphene layer. By way of example, in some embodiments, 1-pyrenebutonic acid succinimidyl ester is employed as a linker to facilitate the coupling of the anti-SARS-CoV-2 antibodies to the underlying graphene layer. In this embodiment, the plurality of anti-SARS-CoV-2 antibodies can cover a fraction of, or the entire, surface of the graphene layer. [0067] The linker modified graphene layer can then be incubated with the antibody of interest in a buffer solution (e.g., NaCO.sub.3-NaHCO.sub.3 buffer solution (pH 9)) at a selected temperature and for a selected duration (e.g., 7-10 hours at 4 C), followed by rinsing with deionized (DI) water and phosphate buffered solution (PBS).)
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nawana (US Pub 2021/0293816), in view of Lee (US Pub 2018/0128823), and further in view of Chen (“Simultaneous measurement of the antibody responses against SARS-CoV-2 and its multiple variants by a phage display mediated immune-multiplex quantitative PCR-based assay.” Frontiers in Microbiology. 1-10. 2022.)
Regarding Claim 4, modified Nawana teaches the integrated device of claim 3.
Modified Nawana is silent to the spike-binding antibody is an anti-Coronavirus spike neutralizing antibody (40592-MM45) for recognizing a Delta variant, or an anti-Coronavirus spike neutralizing antibody (40591-MM48) for recognizing an Omicron variant.
Chen teaches in the related art of SARS-CoV-2 antibodies. See page 5, last paragraph - Having demonstrated that Pi-mqPCR system works well in the evaluation of binding specificity, we next used it to identify the phage-displayed RBD constructs from different variants. We observed binding activity between the phage displaying the RBD of the Delta variant (B.1.617.2) and Omicron variant (B.1.1.529) and that with N501Y and E484K mutations and four commercially available anti-RBD antibodies (Sino Biological), including a polyclonal antibody (T62: Cat. # 40591-T62) and three monoclonal antibodies (R007: Cat. # 40150-R007, RRID Number: AB_2827979, R118: Cat. # 40592-R118, and MM48: Cat. # 40591- MM48). In addition, six anti-SARS-CoV-2 RBD nanobodies selected in previous research (N1-N6) were also used for immunoprecipitation with the recombinant phage. We observed that all four types of recombinant phage could bind the polyclonal antibody in a concentration-dependent manner. However, compared with the wild type, the recombinant phage that displayed RBD mutants showed more reduced enrichment (Figure 5A). See page 6, first paragraph.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the anti-Coronavirus spike neutralizing antibody (40591-MM48), as taught by Chen, for the anti-coronavirus antibody, as taught by Nawana, to allow for specific recognition of the Omicron variant.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nawana (US Pub 2021/0293816), in view of Lee (US Pub 2018/0128823), and further in view of Tarasov (US Pub 2020/0033291).
Regarding Claim 8, modified Nawana teaches the integrated device of claim 1.
Modified Nawana is silent to the interdigital electrode is covered by the graphene film and adhesively attached to an acrylic sheet.
Tarusob teaches in the related art of sensors. [0096] The electrode of embodiment 1, wherein said electrode comprises graphene. [0099] The electrode of any one of embodiments 1 to 4, wherein said at least one polymer capable of mediating a salting-out effect is selected from the group consisting of: poly(ethylene glycol) (PEG), poly(ethylene oxide), poly(propylene glycol), polyglycerol, polyacrylamide (PAM), polyethylineimine (PEI), polymethacrylate or another acrylic polymer.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have covered the electrode by the graphene film in the device of modified Nawana and be attached to an acrylic sheet, as taught by Tarusob, to allow for functionalizing the surface that is exposed to a fluid sample, as taught by Tarusov, in the Abstract.
Claims 9, 10, 11, 12, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nawana (US Pub 2021/0293816), in view of Lee (US Pub 2018/0128823), and further in view of Doshi (WO 2016/145300).
Regarding Claims 9, 10, 11, 12, 15, 16, and 17, modified Nawana teaches the integrated device of claim 1.
Modified Nawana is silent to the back-end system comprises temperature sensor for detecting a breath temperature of the breath sample, wherein the breath temperature is mapped to a temperature compensation curve for estimating a forehead temperature, the back-end system is further configured to monitor a variation in the surface resistance of the graphene film of the control region for determining a respiratory rate, the back-end system comprises a near field communication (NFC) antenna for performing wireless data communication with a portable terminal, wherein the portable terminal supplies wireless power to the back-end system by generating an induced current in the NFC antenna, the induced current is coupled across the graphene films of the detection region and the control region for determining the surface resistance of the graphene films, a processor, wherein: the back-end system comprises a temperature sensor for detecting a breath temperature of the breath sample; the back-end system is configured to monitor a variation in the surface resistance of the graphene film of the detection region for determining a respiratory rate; and the processor is configured to process the digital signals, the breath temperature, and the respiratory rate, and transmit to an external controller for presenting in a user interface, the external controller is configured to: process the digital signals, the breath temperature, and the respiratory rate; execute an integrated medical evaluation on the user; and determine an action that the user needs to take, the integrated medical evaluation is configured to help the user or medical practitioners to understand conditions of the user and whether the user is inflected with COVID 19, identify a high-grade fever, hyperpyrexia, and breath difficulties, and determine whether an immediate medical attention is needed.
Doshi teaches in the related art of a chemical sensor. [0051] the change in electrical characteristics may be read and processed by the sensor controller unit 12. The sensor controller unit 12 comprises of electronic components for reading and processing amplitude and modulation data of electrical changes occurring in the circuit. As used herein, modulation refers to an increase or a decrease in an electrical characteristic. The components of the sensor controller unit may include, but are not limited to, a digital potentiometer or a rheostat, a microcontroller unit (MCU), analog-to-digital converters (ADC), multiplexers, edge connectors, voltage regulators, wires, resistors, capacitors, inductors, a ferrite bead, a Li-ion battery charger integrated circuit (IC), a temperature sensor a near- field communicator (NFC), a radio frequency identification (RFID), a radio frequency (RF), a WI-FI (R) transmitter or any cellular based transmitter. [0058] The chemical sensor device 10 may be wearable by a user. The chemical sensor device may be incorporated into an article of clothing such as, a mask. [0108] In some embodiments, the chemical sensor system may be used to detect and monitor human phenotypic characteristics related to VOC profiles of breath, body odor and/or body fluids. Some embodiments of the chemical sensor system may be used to detect and monitor certain medical and health conditions non-invasively from breath. For example breath contains VOCs that in some cases contain early-detection biomarkers or indicators of certain medical conditions and diseases. In claim 38, wherein the electrical property is a conductivity, a resistance, a voltage, a current, a capacitance, an inductance, or a field-effect transistor property.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the components of a temperature sensor, NFC antenna, a processor, as taught by Doshi, to the device of modified Nawana, to allow for measuring breath.
Regarding Claims 18 and 19, modified Nawana teaches the integrated device of claim 1.
Modified Nawana is silent to the integrated device is embedded and fixed in an underside of a face mask and the integrated device is built into a blowing devices, wherein the blowing device comprises an inlet for performing rapid testing of an individual by exhaling to the inlet.
Doshi teaches [0032] The chemical sensor system of the invention may be used in wide variety of fields. Non-limiting examples of the uses include detection and monitoring of indoor or outdoor air quality, monitoring toxic chemical levels in an industrial plant and monitoring and detection of health conditions by detecting VOCs in patient's breath. [0058] The chemical sensor device 10 may be wearable by a user. The chemical sensor device may be incorporated into an article of clothing such as, but not limited to a mask.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the device of modified Nawana, to a wearable mask, as taught by Doshi, to allow for measuring analytes in the breath.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nawana (US Pub 2021/0293816), in view of Lee (US Pub 2018/0128823), and further in view of Torrente-Rodriguez (“SARS-CoV-2 RapidPlex: A Graphene-Based Multiplexed Telemedicine Platform for Rapid and Low Cost COVID-19 Diagnosis and Monitoring. CellPress. 2020.)
Regarding Claims 13 and 14, modified Nawana teaches the integrated device of claim 1, wherein the back-end system comprises an analog-to-digital converter (ADC) configured to receive analog signals representative of the surface resistance of the graphene films or a difference in the surface resistance of the graphene films, and output digital signals based on the analog signals and wherein the ADC is a 14-bit sigma-delta ADC, or the ADC is integrated as a part of a processor of the integrated device.
Torrente-Rodriguez teaches in the related art of a graphene-based platform for covid-19 detection. The four-channel chronoamperometric measurements were performed by a custom PCB-based wireless potentiostat. An Arm Cortex-M4 microcontroller (STM32L432KC; STMicroelectronics), and a Bluetooth module (SPBT3.0DP2; STMicroelectronics) were used for potentiostat control and wireless communication. A single operational amplifier (AD8605; Analog Devices) was used as the control amplifier, and a quad operational amplifier (AD8608; Analog Devices) was used as a four-transimpedance amplifier to construct the potentiostat loop. A series voltage reference (ISL60002; Renesas Electronics) and the microcontroller unit’s (MCU) builtin digital-to-analog converter were used to generate the voltage bias across the RE and WEs. Four MCU built-in analog-to-digital converter channels were used to concurrently acquire the measurements.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an analog-to-digital converter (ADC) configured to receive analog signals representative of the surface resistance of the graphene films or a difference in the surface resistance of the graphene films, and output digital signals based on the analog signals and wherein the ADC is a 14-bit sigma-delta ADC, or the ADC is integrated as a part of a processor of the integrated device, as taught by Torrente-Rodriguez, to the device of modified Nawana, to allow for making measurements.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 11/25/25, with respect to the 112 rejection over claim 19 have been fully considered and are persuasive. The 112 rejection over claim 19 has been withdrawn.
Applicant's arguments regarding the 103 filed 11/25/25 have been fully considered but they are not persuasive.
First, Applicant argues on page 9 that Nawana discloses only a single, continuous, serpentine or spiral liquid flow channel.
In response, the examiner also cites Nawana, in Fig. 11, which shows multiple paths (channels, [0109] These sensing elements include ports 1201b and 1205b, which are configured to receive a liquid sample generated by using a diluent (e.g., a phosphate buffer solution) with multiple inlets for sensing of the sample. [0113] The sensing elements 1204 and 1208 includes ports 1204b and 1208b for receiving a sample.)
Additionally, the examiner notes that the arrangement of the gas outlet and the plurality of gas inlets to the “gas-liquid interface” is directed to intended use because the “gas-liquid interface” is not part of the claimed device. The PBS and the gas are not positively recited and not part of the claimed device. Therefore, the rejection is maintained.
Further, the examiner notes that pre-injected phosphate-buffered saline is not part of the claimed device since claim 1 states “chamber configured to hold pre-injected phosphate-buffered saline.” In later claims such as anything referred to via the pre-injected PBS such as a molecular linker and a antibody are also not required as part of the claimed device. Therefore, the title of this application “SARS-COV-2 Rapid detection device” is not necessarily directed to this because there is no antibody required to detect SARS-CoV-2.
Second, Applicant argues that the prior art of Nawana and Lee do not detect the virus presence by comparing electrical resistance or capacitance between two different regions.
In response, the examiner notes that there is no calculator or computer or processor positively recited. Further, Nawana teaches [0125] Similar to the previous embodiments, the portions of the graphene layer that are not coupled to cDNA can be passivated via a passivation layer (not shown in FIG. 12), e.g., in a manner discussed above. A plurality of electrodes 2005 deposited on the graphene layer allow measuring an electrical property of the graphene layer, e.g. its electrical resistance, which can change as a result of specific binding of a target viral oligonucleotide, e.g., a target RNA or DNA, to the cDNA probe molecules, thereby allowing the detection of the target viral RNA or DNA. In addition, similar to the previous embodiments, the sensor 2000 can include a reference electrode (not shown in this figure) to which a DC-biased AC voltage, such as that schematically depicted in FIG. 10 can be applied to facilitate the detection of an RNA target sequence of interest. Therefore, the 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-6.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798