Prosecution Insights
Last updated: April 19, 2026
Application No. 18/006,560

DEVELOPMENT OF A SMARTPHONE-BASED BIOSENSOR DEVICE FOR DETECTING SARS-COV-2 ANTIGENS IN BODY FLUIDS USING LOCALIZED SURFACE PLASMON RESONANCE (LSPR)

Non-Final OA §112
Filed
Jan 23, 2023
Examiner
MONTGOMERY, ANN Y
Art Unit
1678
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Minh Van Phan
OA Round
1 (Non-Final)
70%
Grant Probability
Favorable
1-2
OA Rounds
3y 10m
To Grant
96%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allow Rate
457 granted / 657 resolved
+9.6% vs TC avg
Strong +26% interview lift
Without
With
+26.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
24 currently pending
Career history
681
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
44.3%
+4.3% vs TC avg
§102
18.1%
-21.9% vs TC avg
§112
17.9%
-22.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 657 resolved cases

Office Action

§112
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. Election/Restrictions Applicant’s election without traverse of Group III (claims 13-15) in the reply filed on 12/23/25is acknowledged. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claims 13-1 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 13, line 1 and elsewhere recites a “nanostructure-based LSPR (localized surface plasmon resonance) biosensor”. It is not clear anywhere in the claims (13-15) as to whether the biosensor requires a nanostructure. While the term “nanostructure-based” is used, this term does not make clear whether or not the claimed biosensor requires a nanostructure. Examiner notes that while the claims are read in light of the specification, the specification is not read into the claims. It is also not clear as to the location of the linker on the biosensor. For examination purposes, the claimed biosensor will be interpreted as comprising a nanostructure (such as nanoparticles such as disclosed in Applicant’s specification as filed), and that the linker is provided on the nanostructure. Examiner notes that it appears that the LSPR biosensor comprises a nanostructure and the biosensor also comprises opposing ends secured with ceramic ferrules, recited in line 9-10 of claim 13. [Examiner notes that “localized surface plasmon resonance biosensor” is interpreted to mean that the biosensor is capable of producing localized surface plasmon resonance.] Also, claim 13, lines 2-6 recites “a nanostructure-based LSPR (localized surface plasmon resonance) biosensor having a linker molecule or polymer chain or nucleic acid (DNA, RNA) or peptide strand or capture antibody or polydopamine or alkane thiol or synthetic molecules with varying carbon chains comprised of -NF 2 or -COOH or -SH group at one end or both ends of the molecules to the nanostructure-based LSPR biosensor” . (Emphasis added). It is not clear as to what Applicant means by “with varying carbon chains”. How are the carbon chains on the linker varied? Are each carbon chain varied from each other? How are they varied? (Do the carbon chains of the linker have different groups from each other?) It is also not clear as to what Applicant means by “a biosensor having a linker molecule ….with varying carbon chains comprised of….groups at one end or both ends of the molecules to the nanostructure-based LSPR biosensor” (emphasis added). The claim also lacks antecedent basis for “the molecules. For examination purposes, “the molecules” is interpreted to be referring to the linker molecule or polymer chain or nucleic acid (DNA, RNA) or peptide strand or capture antibody or polydopamine or alkane thiol or synthetic molecules. Also it is not clear as to what Applicant means by “ to the nanostructure-based LSPR biosensor” For examination purposes, the claims are interpreted to mean that the nanostructure has attached thereon a linker molecule (or polymer chain or nucleic acid, or peptide strand or capture antibody or polydopamine or alkane thiol or synthetic molecules) with --NH 2 or --COOH or --SH group attached to a nanostructure of the biosensor, as this appears to be Applicant’s intention. Also claim 13, lines 6 recites “an intermediate layer comprised of polyethylene glycol (PEG) or streptavidin or avidin or biotin or Polyethylenimine (PEI) or polyaziridine or dextran to the linker molecule ” (emphasis added) It is not clear as to the relationship between the biosensor and the intermediate layer. It is also not clear as to the relationship between the intermediate layer and the linker molecule (or the alternatives of polymer chain, nucleic acid, peptide strand, capture antibody, polydopamine, alkane thiol, synthetic molecules….”) Examiner notes that line 8 refers only to “the linker molecule”; however, the alternatives (mentioned above) are not referred to in line 8, which therefore presents ambiguity. For examination purposes, claim 13 is interpreted to mean that the biosensor comprises a nanostructure comprising a linker molecule attached to the nanostructure and an intermediate layer attached to the linker molecule. However, clarification is requested. Claim 13, lines 8-9, recites “and probe antibodies or primary antibodies and/or secondary antibodies applied to the intermediate layer” (emphasis added). Examiner notes that claim 13 is directed to a system, rather than a method. It is not clear whether or not the biosensor comprises the probe antibodies or primary antibodies and/or secondary antibodies, or whether lines 8-9 is reciting an intended use. For examination purposes, the claim is interpreted to mean that the biosensor comprises the probe antibodies or primary antibodies and/or secondary antibodies attached to the intermediate layer. Claim 14 recites in line 2, “one end of the flow cell”. It is not clear if this “one end” is the same or different from the “one end of the flow cell” in claim 13, line 16. Similarly, claim 14, line 3, “the one end of the flow cell”, and it is not clear if this “one end” is the same or different from the “one end of the flow cell in claim 13, line 16. Claim 14, line 4, “an opposite end of the flow cell”, and in line 5, “the opposite end of the flow cell”. It is not clear if this “opposite end” is the same or different from the “opposite end of the flow cell” in claim 13, line 16. Claim 13, line 3, recites “nucleic acid (DNA, RNA)”. It is not clear whether or not “nucleic acid” is limited to DNA and RNA, or whether it encompasses other molecules such as PNA. Claim 15, line 2, recites “an Au/Ag/Al/Cu/Fe/Mn”. It is not clear if the claim is reciting these elements in the alternative or whether the biosensor comprises all these elements. For examination purposes, the claim is interpreted to refer to these elements in the alternative. Claim 15, lines 2-3, recites “NP-coated fiber optic LSPR biosensor”. It is not clear what is meant by “NP-coated”. For examination, purposes, the claim is interpreted to mean that the biosensor comprises a fiber optic coated with nanoparticles. Allowable Subject Matter Claim 13 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action. Claims 14-15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter. It was not found in the prior art search a teaching or suggestion for a system comprising, among other things, a nanostructure-based LSPR (localized surface plasmon resonance) biosensor [interpreted to mean a biosensor comprising a nanostructure and capable of producing localized surface plasmon resonance ] [ wherein the nanostructure has attached thereon ] a linker molecule or polymer chain or nucleic acid (DNA, RNA) or peptide strand or capture antibody or polydopamine or alkane thiol or synthetic molecules with varying carbon chains comprised of -NF 2 or -COOH or -SH group at one end or both ends of the molecules [attached] to the nanostructure-based LSPR biosensor ; an intermediate layer comprised of polyethylene glycol (PEG) or streptavidin or avidin or biotin or Polyethylenimine (PEI) or polyaziridine or dextran [attached] to the linker molecu le; and probe antibodies or primary antibodies and/or secondary antibodies [attached to the intermediate layer] . Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. 1) US 20140134609 (Tan). Tan teaches colorimetric method for detecting a polynucleotide strand binding molecule using one type of metal particles modified with a single type of interacting molecules , that is capable of specifically binding to nucleic and of protecting the metal particle from aggregation. Abstract. Surface plasmon resonance may be used to determine binding kinetics. Para. 0065. T he interacting molecule may be bound to the surface of the metal particle via a linker, ionic attachment, chemisorption or physical adsorption . T he interacting molecules may be conjugated to the metal particles by a thioether linkage. Such thioether linkages when bound to the metal particle stabilize the metal particles against aggregation. In some embodiments, there is provided the method as described herein, wherein chemisorption is via a functional group which bind the metal particle, wherein the functional group selected from the group consisting of thiols and peptide sequences comprising cysteine and thiolated amino acids . Para. 0085. I n case the metal particle is a colloidal gold, the gold nanoparticle may be stabilized against aggregation by using long hydrocarbon ligand chains consisting of various functional groups. One end of these molecules is adsorbed on the gold surface, whereas the other end points towards the solution. For example, mercaptocarboxylic acid molecules may be adsorbed on a gold particle surface. Examples of water-soluble metal particles include carboxylic acids as functional groups which stabilize the gold particles by electrostatic repulsion. Such carboxylic groups may further be exploited for the conjugation of other molecules to the particles. Para. 0086. The choice of ligand may depend on the particle size and the solvent. The ligands may also be used as anchor points for further attachment of biological molecules. For example, mercaptocarboxylic acids may be used to stabilize the gold particles due to the strong affinity of sulfur for gold. Thiolated interacting molecules can directly be bound on gold particles surface via thiol-gold affinity interactions. For example, aptamer-gold nanoparticles may be created for recognition of nucleic acid binding molecules. Other examples of interacting molecules that may replace some of the original stabilizer molecules (i.e. thioether linkage) when they are added directly to the particle solution comprise interacting molecules that have a functional group which can bind to the metal surface, such as gold surface (like thiols or specific peptide sequences). Accordingly, in some examples, interacting molecules may comprise but are not limited to oligonucleotides, peptides, and PEG that may be linked to metal particles, such as gold particles. Para. 0087. 2) US 20080280374 (Potyrailo). Potyrailo discloses systems for detecting analytes comprising, a metal film having surfaces comprising su bmicron structures; a light source for illuminating a surface of the metal film ; and an optical detection su b system for collecting optically altered light, wherein the altered light is indicative of surface plasmon resonance on the film, and detecting one or more properties of the analytes based on the collected light. See abstract. Th e displaced light is indicative of surface plasmon resonance on one or more of the surfaces of the film, and detecting one or more properties of the analytes is based on the collected light. The system may be adapted to produce displaced light having a certain reflective index resolution . Similarly, t he submicron structures may comprise nanoholes or nanopillars having a diameter that is less than or equal to 100 nm and may further comprise nanoholes having a diameter that is less than or equal to 50 nm. The metal film may comprise gold (Au) a nd may be between 40-120 nm thick. The analytes may comprise a variety of unlabeled or labeled biological or biochemical materials such, but not limited to, fluorescently labeled materials. The nanopillars may comprise a plurality of composite layers that may, depending on the application, have differing dielectric properties. The metal film may comprise random or predetermined patterns of submicron structures. The metal film may be freestanding, wholly or partially fixed or otherwise supported on a substrate. The substrate may comprise a variety of materials including, but not limited to, quartz. Para. 0013. The SPR sens or is adapted for analyzing biological and biochemical analytes, and comprises a metal film h aving surfaces comprising s ubmicron structures, wherein the metal film has a surface plasmon resonance. The metal film may be functionalized with one or more biological or biochemical analytes so that the analytes alter the surface plasmon resonance of one or more of the surfaces of the metal film. Para. 0014. The system improve s SPR sensor detection capabilities , achieved in part by creating a pattern on a metal film. The superior properties include extraordinary optical transmission and spectral filtering properties. Patterning of the metal film is achieved by creating submicron structures in or on the metal film enhances near-field light intensity. Such submicron structures may include but are not limited to nanoholes and nanopillars (also referred to as nanoislands). This enhancement enables detection of more subtle changes in chemical and biological materials and at on smaller scale than unenhanced metal films. Nanoholes refers to depressions or cavities that extend into the metal layer that generally have a definable depth and perimeter. The term nanopillars is interchangeable herein with nanoislands and refers to structures that extend outward from the primary surface of the metal film or substrate. Para. 0031. In some of the embodiments, t he submicron pattern comprises a plurality of holes or pillars that generally have a diameter that is substantially the same as the wavelengths of light. Para. 0032. The amount and quality of the collected light in part depends on the extent of optical displacement and the intensity of the light. The collected light is indicative of the surface plasmon resonance on one or more of the surfaces of the film, which is altered (when compared to a smooth metal surface) by the submicron structures as well as the analytes. The detected light is then used to analyze and quantify one or more properties of the biological or biochemical analytes. Th e analytes may be univariate or multivariate. Para. 0033. The light source 12 may be a variety of suitable light sources including but not limited to polychromatic illumination devices and lasers. Para. 0034. When the biological or biochemical materials are applied to the metal film, the materials interact with the metal film. This interaction affects the electro-optical properties of the film, which effectively alters the SPR or refractive index response of the metal film sensor. Para. 0036. FIG. 8 illustrates embodiments where nanohole arrays are formed through the entire metal film thickness or with a certain remaining thickness of metal in the film. These metal films with nanohole arrays are either on a substrate or free standing. Array 70 is shown with nanoholes 72 extending entirely through metal film 78 and adhesive layer 74. Adhesive layer 74 is used to fix metal film 78 to substrate 76. Substrate 76 may comprise a number of suitable types of transmissive materials such as quartz. Other useful metal include , but are not limited to, aluminum and silver. The adhesion layer promotes adhesion of gold to the glass surface. Examples of suitable adhesives include, but are not limited to, chromium and titanium. Examples of substrate materials include glass, quartz, silicon, magnesium fluoride, calcium fluoride, and polymers such as polycarbonate, Teflon AF, and Nafion. Array 80 is shown with nanoholes 82 extending partially through metal layer 84. Metal layer 84 is similarly fixed to substrate 86. Para. 0042. 3) US 20110014724 (Sim). Sim discloses a method of detecting bioproducts using Localized Surface Plasmon Resonance (LSPR) of gold nanoparticles, which can diagnose bioproducts based on changes in the maximum wavelength occurred by an antigen-antibody reaction after immobilization of the gold nanoparticles onto a glass panel. Abstract. Lim discloses a method of detecting PSA, comprising: (a) immobilizing PSA onto a localized surface plasmon resonance (LSPR) sensor comprised of gold nanoparticles, the surface of which is modified with an organic adsorbent, and a cover glass where the gold nanoparticles are immobilized; (b) flowing PSA-ACT complex onto the sensor having the immobilized PSA and (c) determining light-scattering spectra by using dark-field microscopy and a resonant Rayleigh scattering micro-spectroscopy system and analyzing mobility of the maximum wavelength. Para. 0016. Disclosed is used of LSPR of Au nanoparticles, as a biochip or biosensor measurement technique. Para. 0021. Au nanoparticles are dispersed and immobilized onto a glass panel as shown in FIG. 1. By taking a picture of a dark field image of the Au nanoparticles immobilized as such, the difference in color depending on the size of particles was observed (FIG. 2). As a result, it was confirmed that the color changed from blue to red. Further, by determining a light scattering spectrum by using a CCD camera , it is found that the maximum wavelength varies depending on the size of nanoparticles (FIG. 2). Like this, upon binding of a bioproduct to the Au nanoparticles, surface morphology of the nanoparticles changes according to the amount of material bound thereto, therefore it is possible to sense bioproducts through such changes in the maximum wavelength. Para. 0023. The wavelength of the Au nanoparticles immobilized on the glass panel was 732.44 nm, and after modification of the surface of the Au nanoparticles, the wavelength was increased to 747.15 nm. When PSA antibodies were bound to the Au nanoparticles by using EDC/NHS, the wavelength was changed to 761.8 nm. Further, after flowing the target material, PSA-ACT complex, the wavelength was increased to 775.9 nm. It means that mobility of the maximum wavelength was increased to 14.1 nm. As shown above, it is possible to detect a very small amount of PSA-ACT complex such as 100 pg/ml by measuring increase in the maximum wavelength . Para. 0040. 4) US 20120188551 ( Langhammar ). Langhammar discloses an arrangement comprising at least one sensor nanoparticle supporting Localized Surface Plasmon Resonance (LSPR), at least one sensing material and at least one separating layer which separates the at least one sensor nanoparticle from the at least one sensing material. The arrangement allows for indirect sensing studies of change in and on the surface of a sensing material or environment by the sensor nanoparticle. The arrangement may also be used for optical temperature measurements and calorimetry, optical differential scanning calorimetry (DSC), to study hydrogen storage, catalytic reactions or for NOx sensing. See abstract. The arrangement may be used to measure, at ultra-high sensitivity, an induced structural, chemical and/or electronic change in a sensing material or a temperature change caused by, for example, a chemical/catalytic reaction on/of the sensing material or by a phase transition in/of the sensing material or by a temperature change in the surrounding medium. The sensing material includes nanoparticles , thin films or a bulk material made from a solid, a liquid, soft matter or a gas. The induced change is detected as a change in the optical response of the optically active sensor nanoparticle(s) by reading out the altered optical response of said sensor nanoparticle(s). This is in contrast to the previously known refractive index sensing and direct sensing where the sensor nanoparticle is in direct contact with the surrounding medium/environment and the entities to be sensed or itself undergoes a structural or electronic or chemical change during the sensing event, respectively. Para. 0016. The separating layer is selected from transition metal oxides , sulfides, nitrides, carbides, alkaline earth metal oxides and hydrogels. Para. 0035. The separating layer is made of a metal oxide such as aluminum oxide Al 2 O 3 , magnesium oxide MgO, beryllium oxide BeO, barium oxide BaO, cerium oxide CeO, Ce 2 O 3 , semiconductor oxides such as silicon dioxide SiO 2 ; insulators, carbides, nitrides, sulfides, and polymers such as poly(hydrogenmethylsiloxane) PHMS, Poly(dimethylsiloxane) PDMS or Poly(methylmethacrylate) PMMA. Para. 0037. Disclosed are sensor nanoparticles, embedded in an oxidewhose dielectric properties change when NOx is bound into the oxide layer. T he bulk part of the oxide layer served as inert separation layer to protect the sensor nanoparticle from the harsh NOx environment. Only the outermost (towards the NOx environment) part of this oxide layer then interacted with the NOx and underwent chemical reaction. The chemical transformation gave rise to a change of the dielectric properties of the outermost region of the separation oxide layer. Para. 0077. Also disclosed are Au nanodisks serving as sensor nanoparticles … The transmission of white light through the sample was detected as a function of wavelength, using an array spectrometer. Para. 0079. 5) US 20130003070 ( Sezaki ). Sezaki discloses a chip for localized surface plasmon resonance sensor, which is able to provide a localized surface plasmon resonance sensor of higher sensitivity. A structure of the invention is characterized by including a planar section and tubular bodies, wherein the tubular bodies are vertically arranged so that openings thereof open at the planar surface of the planar section, an average inner diameter of the openings of the tubular bodies is within a range of from 5 nm to 2,000 nm …, and the bottom of the tubular bodies is aspherical. Abstract. T he chip for localized surface plasmon resonance sensor is characterized by forming, on a substrate, a structure including a planar section and tubular bodies, wherein the tubular bodies are vertically arranged in such a way that openings thereof open at the planar surface of the planar section …. and also by forming a metal layer so as to cover at least a part of the surface of the structure and reflect a surface structure of the structure. Para. 0030. C oupling between the free electrons in the metal inside the recesses and at the periphery of the openings of the tubular bodies and incident light takes place, and an electric field is concentrated at the inside of the recesses and at the periphery of the openings of the tubular bodies to generate a very strong localized surface plasmon resonance. Accordingly, such an effect is obtained that there can be provided a localized surface plasmon resonance sensor of higher sensitivity. Para. 0031. I rradiation light such as propagating light, near-field light, evanescent light or the like may be used. As propagating light, natural light, laser beams and the like can be used. Para. 0194. Gold was vacuum deposited on the surface of the resulting structure in a thickness of 100 nm according to a vacuum deposition method to provide a sensor chip. The measurement of transmission spectrum of the sensor chip revealed a plasmon resonance-derived absorption peak. Each liquid having different refractive indices was dropped on the surface, followed by measurement of transmission spectrum. Para. 0234. When the sensitivity of the sensor chip was measured by calculating a variation in peak shift amount of the transmission spectrum relative to the refractive indices of the liquids on the surface of the sensor chip. Thus, it was found that the sensor chip of this example was of a transmission type and could be a plasmon resonance sensor of high sensitivity. Para. 0235. Gold was d eposited on the surface of the resulting structure in a thickness of 100 nm to provide a sensor chip ….Th e sensor chip of this example was found to be of the transmission type and also to serve as a plasmon resonance sensor of high sensitivity. Para. 0241. An antibody of C-reactive protein (CRP) was fixed on the sensor chip surface . CRP antigen solution was dropped on the sensor chip surface to conduct the antigen-antibody reaction of CRP. Thereafter, the sensor chip surface was cleaned with a solution , followed by measurement of transmission spectrum of the sensor chip. W here no antigen was reacted ( i.e., the "blank"), the peak wavelength was at 642.1 nm, whereas when the antigen was reacted, the peak wavelength was found at 642.8 nm, thus the peak wavelength being shifted to a longer wavelength side by 0.7 nm. Para. 0257. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Ann Montgomery whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0894 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri, 9-5:30 PM PST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Greg Emch can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /Ann Montgomery/ Primary Examiner, Art Unit 1678
Read full office action

Prosecution Timeline

Jan 23, 2023
Application Filed
Mar 28, 2026
Non-Final Rejection — §112 (current)

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Expected OA Rounds
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