DETAILED ACTION
Claims 1-25 are pending.
Election/Restrictions
Applicant’s election without traverse of claims 1-22 in the reply filed on 04/14/2026 is acknowledged.
Claims 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 on 04/14/2026.
Claims 1-22 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/26/2023 has been considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1.Claims 1-2, 9, 14, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diouf et al., A novel electrochemical sensor based on ion imprinted polymer and gold nanomaterials for nitride ion analysis in exhaled breath condensate. Talanta. Vol. 209. 1 March 2020. https://doi.org/10.1016/j.talanta.2019.120577.
Diouf teaches a method of detecting an airborne analyte, comprising:
contacting an ambient air sample suspected of containing the analyte with an aqueous aerosol and subjecting the air sample and aqueous aerosol to condensation, thereby producing a liquid-analyte solution (see figure 1, see pages 10-11 under “3.5. Application of nitrite IIP sensor in exhaled breath samples”);
contacting the liquid-analyte solution with an imprinted micelle, wherein the imprinted micelle comprises an analyte imprint and contains a salt or electrolyte solution (see page 2 “Sodium nitrite (NaNO2), silver nitrate (AgNO3), acetate, ammonium nitrate, phosphate buffered saline (PBS), gold chloride trihydrate (HAuCl43H2O) (99.99%), polyvinyl alcohol (PVA) (98%), glutaraldehyde (GA) (25%), methanol, hydrochloric acid (HCl), and sulphuric acid (H2SO4) were purchased from Sigma Aldrich… Then, a volume of 30 µL of a sodium nitrite solution (100 mg NaNO2 dissolved in 1 mL distilled water) was deposited on the electrode surface that was already modified by 2-ATP”, see abstract, see page 11 under “Conclusion”); and
detecting an electrochemical signal produced upon binding of the analyte to the imprinted micelle, releasing the salt solution, thereby detecting the airborne analyte (see figure 6, see page 11 under “4. Conclusion”, see figure 9) (instant claim 1).
Diouf teaches the analyte comprising a toxin and/or an inorganic particle (see abstract teaching the detection of nitrite) (instant claim 2). Diouf teaches wherein the liquid-analyte solution and imprinted micelle are contacted in an electrochemical cell (see page 2 “For the practical application of the IIP sensor, EBC samples were collected in the morning from volunteers in our laboratory. After rinsing their mouths, the volunteers were asked to blow into a mouthpiece. The blown air was trapped in a pipe immersed in ice. Finally, the obtained liquid sample was recovered in a beaker. In order not to influence the measurement of nitrite in EBC, the volunteers were asked to keep their mouths dry during sampling and swallow the saliva from time to time. To avoid the chemical transformations in the EBC samples, they were immediately analyzed by using the developed IIP sensor. All experiments were performed at a room temperature of 25 °C”) (instant claim 9). Diouf teaches the limit of detection being under 5 (see abstract “Under improved experimental conditions, the nitrite IIP sensor exhibits responses proportional to nitrite concentrations (R2=0.96) over a concentration range of 0.5–50 µg mL−1 with a detection limit (LOD) of 4 μmol L−1 (signal-tonoise ratio S/N = 3) (instant claim 21). Diouf teaches the salt solution comprises ferrous cyanide (see page 8 “Ferri/ferrocyanide ([Fe(CN)6]3-/4-), as redox probe, is used to monitor all stages of the IIP sensor development. It provides information on the transfer of electrons between the deposited layer and the electrode surface.”) (instant claim 14). Diouf teaches a processor that receives data from an electrometer coupled to a sensor comprising the imprinted micelle; and comparing the data to background data to estimate particle-micelle interactions (see figures 1-2, see figures 4-9, see page 10 under “Application of nitrite IIP sensor in exhaled breath samples”) (instant claim 22).
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.
2.Claims 3-5, 10-12 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Diouf as applied to claims 1-2, 9, 14, and 21-22 above, in view of Lee et al., Potentiometric Biosensors Based on Molecular-Imprinted Self-Assembled Monolayer Films for Rapid Detection of Influenza A Virus and SARS-CoV-2 Spike Protein. ACS Appl. Nano Mater. 2022, 5, 5045-5055.
The teachings of Diouf as it pertains to claims 1-2, 9, 14, and 21-22 are discussed in the 35 USC 102 rejection above.
Diouf does not teach a virus, specifically human coronavirus or SARS-CoV2, the electrochemical cell comprising a glass vessel with deionized water, the solid substrate of the electrochemical cell, the glass being coated with PTFE, and the methods being multiplexed to detect two or more different viruses.
Lee teaches the human virus being SARS-CoV-2 (see abstract “The sensor unambiguously detected and differentiated H1N1 and H3N2 influenza A virions as well as the spike proteins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)”) (instant claims 3-5). Lee teaches wherein the electrochemical cell comprises a glass vessel containing deionized water (see page 5052 “The chips coadsorbed with template molecules and SAM were rinsed with DI water and then soaked in 10 mL of a 3 M NaCl solution at 37 °C for 3 h with gentle agitation, which was shown to be effective in selectively removing template molecules without affecting the integrity of SAM on the surface. Thereafter, the washed chips were
rinsed with DI water and then soaked in 10 mL of DI water at 37 °C for 30 min with gentle agitation…The three electrodes were all placed in a 15 mL electrochemical glass cell vial with 15 mL of a KCl solution (0.1 M) containing [Fe(CN)6]4−/[Fe(CN)6]3− (2 mM each). EIS”) (instant claim 10). Lee teaches the glass vessel being coated in polytetrafluoroethylene (PTFE) (see page 5052 “The prepared substrate was covered with a PTFE tape with a 6 mm diameter hole made by a hole puncher. The exposed 6 mm diameter circular area was subjected to the molecular imprinting of an analyte of interest, as described in the next section. The PTFE tape remained on the substrate as a mask during the imprinting process as well as potentiometric detection.”) (instant claim 11). Lee teaches wherein the imprinted micelle is adhered to a solid support in the electrochemical cell (see figure 1 showing the 3D molecular imprinted Au substrate, see page 5047 “OH-terminated thiols are adsorbed onto a Au-coated
Si chip together with template molecules, which are target analytes such as virions (Figure 1a,b). The template molecules, being larger than thiols, adsorb first onto the Au surface and fit
conformally onto the surface structure (e.g., concave; with a roughness of ∼62.5 (±15.2) nm in the current study; Figure S2a) originating from the roughness of the underlying unpolished Si surface, which ranges from nano to micron in scale. At the same time, the thiols adsorb around the template molecules, reacting with the Au surface via Au−sulfur bonds, and crystallize into a 2 nm thick self-assembled monolayer (SAM), wrapped tightly around the template.”) (instant claim 12). Lee teaches the method is multiplexed and the imprint micelle comprises micelles specific for a plurality of analytes, the analytes having at least one molecularly imprinted particle specific for each analyte, the plurality of analytes comprising at least two different viruses and the viruses being respiratory viruses coronavirus and the influenza virus (see abstract “The sensor unambiguously detected and differentiated H1N1 and H3N2 influenza A virions as well as the spike proteins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and Middle-East respiratory syndrome (MERS) coronavirus in human saliva with limits of detection reaching 200 PFU/mL and 100 pg/mL for the viral particles and spike proteins, respectively.”, see page 5047 “In this study, we demonstrate the applicability of the 3D molecular imprinting technique for a rapid, specific, and highly sensitive detection of (1) enveloped RNA viruses using two different subtypes of influenza A virions, H1N1 and H3N2, and (2) the purified Sproteins of SARS-CoV-2 and Middle-East respiratory syndrome (MERS) coronaviruses”) (instant claims 15-20).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the method of using imprinted micelles to detect an airborne analyte taught by Diouf with the methods of multiplexing imprinted molecular particles for the detection of influenza and coronavirus taught by Lee. Lee provides motivation by teaching that a potentiometric sensor with molecular imprinting is an effective method for viral testing as it provides the sensitivity of RT-PCR in detecting very low viral titers and differentiating different viral subtypes while producing results in less than 5 minutes (see page 5046). Lee provides motivation by teaching that the use of a glass vessel, deionized water, and PTFE tape are materials and methods were known and used in the art before the filing of the instant application (see page 5046). Lee provides motivation by teaching that the methods of multiplexing imprinted molecular particles for the detection of influenza and coronavirus taught by Lee provides a highly effective point-of-care diagnostics platform for a fast, accurate, and specific detection of various viral pathogens (see page 5052). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
3.Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Diouf as applied to claims 1-2, 9, 14, and 22 above, in view of Niu et al., Core-shell nanoparticles coated with molecularly imprinted polymers: a review. Microchim Acta 183: 2677-2695, 2016 (IDS filed on 07/26/2023).
Diouf teaches the imprinted particle is a gold nanoparticle (see abstract “Then, a polymer matrix composed of polyvinyl alcohol (PVA) crosslinked with glutaraldehyde (GA) was combined with gold nanoparticles (Au-NPs) to cover the modified Au-SPE and complete the fabrication of the Ion Imprinted Polymer (IIP) sensor.”, see page 2 under “2.2. Preparation of the gold nanoparticle solution”) (instant claim 7).
Diouf does not teach the imprinted micelle being double-layered.
Niu teaches a double-layered imprint micelle, where the outer layer comprises the analyte imprint and the analyte imprint comprises at least one molecularly imprinted particle specific for the analyte (see figure 1, see page 2689 “After they synthesized different composites materials for each targets using different template, the detection limits can reach to 200 fM, 20 pM, 400 f.”) (instant claim 6).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the method of using imprinted micelles to detect an airborne analyte taught by Diouf with the double-layered imprint micelle taught by Niu. Niu provides motivation by teaching that molecularly imprinted polymers can act as receptors for target molecule (template recognition) (see page 2677). Niu provides motivation by teaching that templates of the target molecule being on the outer layer allows for a more complete removal of the template and easier rebinding progress of the target molecules with recognition sites, which greatly improved the mass-transfer efficiency (see page 2678). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
4.Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Diouf and Lee as applied to claims 3-5, 10-12 and 15-20 above, in view of Choi et al., Al-Coated Conductive Fiber Filters for High-Efficiency Electrostatic Filtration: Effects of Electrical and Fiber Structural Properties. Sci Rep 8, 5747 (2018). https://doi.org/10.1038/s41598-018-23960-9.
The teachings of Diouf and Lee as it pertains to claims 3-5, 10-12, and 15-20 are discussed in the 35 USC 103 rejection above.
Diouf does not teach the use of a conductive fiber filter.
Choi teaches the use of a conductive fiber filter (see abstract, see page 16496 under “fabrication of the Conductive Fibrous Filter” and “Filtration Test”) (instant claim 13).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the method of using imprinted micelles to detect an airborne analyte taught by Diouf with the conductive fiber filter taught by Choi. Choi provides motivation by teaching that conductive fiber filters have a low sheet resistance, robust mechanical durability and high oxidative stability (see abstract). Choi provides motivation by teaching that the conductive filters were able to be fabricated successfully via a cost effective, simple, and scalable solution-dipping process (see page 16496). Choi further provides motivation by teaching that particles in the range of 30-400 nm were captured with the removal efficiency of >99.99% at airflow velocity (see page 16500). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
Prosecution Insights