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 .
Response to Amendment
The Amendment filed 09/04/2026 has been entered. Claims 1-18 remain pending in the application. Claim 18 is withdrawn. New grounds of rejections necessitated by amendments are discussed below.
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 applicant regards as his invention.
Claims 1-17 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.
Regarding claim 1, claim 1 recites the limitation "the calculation” in line 11. There is insufficient antecedent basis for this limitation in the claim. Claims 2-17 are rejected by virtue of their dependency on claim 1. It is suggested to recite “the calculation” as “the calculating” if referring to the “calculating” step of line 10.
Regarding claim 1, claim 1 recites the limitation "the first signals” (plural) in line 17. There is insufficient antecedent basis for this limitation in the claim. Note that line 6 establishes a singular “first signal”. Additionally, it is unclear if “the first signals” is the same or different from “a first signal” of line 6. For examination purposes, “first signals of each of the plurality of secondary standards” is interpreted as different from “first signal”. Claims 2-17 are rejected by virtue of their dependency on claim 1.
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.
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.
Claims 1-4, 7, 10-11, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Dees et al. (US 20100285490 A1; cited in the IDS filed 06/27/2023) in view of Sakaki et al. (US 20210215680 A1; effectively filed 09/13/2016).
Regarding claim 1, Dees teaches a method of measuring a concentration of an analyte without a spectrometer (abstract and paragraph [0078] teaches a method comprising determining the concentration of an agent, i.e. analyte, in a sample with a detection means such as a camera or photomultiplier tube and computer, i.e. without a spectrometer), comprising:
reacting a test solution comprising the analyte with a nanoparticle solution comprising a plurality of nanoparticles and an optical waveguide element to form a sandwich structure (Fig. 6 and [0035], [0131],[0133] teaches a sample fluid with an agent of interest, i.e. analyte, is contacted with a first and second binding molecule, which includes a gold nanoparticle, and a reactive surface to form a sandwich structure; note that while Fig. 6 shows a single nanoparticle, [0021], [0045], [0370], and [0410] teaches that multiple particles, i.e. multiple nanoparticles, are present for the sandwich capture assay; [0089] teaches a reagent pack of gold particles; [0226] teaches the capture binding molecule are immobilized on an optical waveguide to form a reactive surface, therefore the reactive surface of Fig. 6 is interpreted as a waveguide; [0017] teaches a sandwich type assay; therefore, a test solution comprising an analyte and nanoparticle solution of gold nanoparticles are reacted on a waveguide to form a sandwich structure for a sandwich type assay as shown in Fig. 6); and
obtaining a first signal by using a photodetector to directly measure evanescent wave energy of the optical waveguide element after evanescent waves generated in the optical waveguide element are absorbed and/or scattered by the plurality of nanoparticles of the sandwich structure formed of the plurality of nanoparticles, the analyte, and the optical waveguide element ( [0349]-[0353] and [0370] teaches measuring scattered light, i.e. signal, by photodetection devices, i.e. photodetector; [0261]-[0270] discusses evanescent wave and detecting light from the reaction solution and waveguide reactive surface; [0035] and Fig. 6 teaches one of a plurality of sandwich structures formed of nanoparticles, analyte, and the waveguide; [0342] teaches scattering of light in an evanescent wave is observed; therefore, evanescent wave energy of the waveguide is directly measured after the evanescent waves are scattered by the nanoparticles in the sandwich assay), and calculating the concentration of the analyte based on the first signal ([0078] teaches determining concentration of an agent in a sample based on the data; [0115],[0126] teaches sandwich assays to quantitate the agents; [0267] teaches methods that utilize TIR for quantitation of an agent in a sample; [0354] teaches the detection and measurement are correlated to the concentration of the agents in the sample);
wherein a detection recognition element (Fig. 6 and [0035] teaches an “second antibody” bound to the agent and linked to a biotin tag) is indirectly conjugated on a surface of each of the plurality of nanoparticles through a first anti-nonspecific adsorption layer directly modified on the plurality of nanoparticles (Fig. 6 and [0035] teaches the second antibody is indirectly attached to the surface of the gold nanoparticle, e.g. via the biotin and third antibody; [0194] teaches a binding molecule is attached to a particle through a surface coating of reactive groups, which is interpreted as the “first-anti-nonspecific adsorption layer”; note that while Fig. 6 shows one nanoparticle, [0184], [0370], and [0410] teach multiple particles that bind to binding molecules, therefore each nanoparticle would have detection recognition elements, i.e. antibody, indirectly conjugated to its surface through an anti-nonspecific adsorption layer, i.e. surface coating), and a capture recognition element (Fig. 6 and [0035] teaches an antibody bound to the surface) is indirectly conjugated on a waveguide surface of the optical waveguide element through a second anti-nonspecific adsorption layer directly modified on the waveguide surface of the optical waveguide element (Fig. 6 and [0035] teaches an antibody bound to the surface; [0226] teaches the surface is a waveguide; [0233] teaches binding molecules are attached to a surface through a chemical coupling means, which is interpreted as the “second anti-nonspecific adsorption layer”; therefore, the antibody is indirectly conjugated to the waveguide surface);
wherein the detection recognition element (Fig. 6 and [0035] teaches an “second antibody” bound to the agent and linked to a biotin tag) and the capture recognition element (Fig. 6 and [0035] teaches an antibody bound to the surface) are respectively bound with the analyte at different binding sites of the analyte (Fig. 6 shows the two antibodies bound to the agent, i.e. diamond shape, at different locations of the agent);
wherein the plurality of nanoparticles are noble metal nanoparticles (Fig. 6 and [0035],[0110] and Fig. 6 teach gold nanoparticles);
wherein the concentration of the analyte can be directly calculated based on the first signal without additional signal amplification step ([0078] teaches determining concentration of an agent in a sample based on the data; [0115],[0126] teaches sandwich assays to quantitate the agents; [0267] teaches methods that utilize TIR for quantitation of an agent in a sample; [0354] teaches the detection and measurement are correlated to the concentration of the agents in the sample; [0078],[0115],[0126],[0267],[0354] describe calculation of concentration of the agent based on the signal and is silent on any additional signal amplification steps, therefore the calculation is directed calculated without an additional signal amplification step; [0178]-[0179] teaches sample preparation steps, which can optionally include an amplification step, however, since the amplification step is grouped as an alternative, the methods are interpreted as teaching calculating the concentration without the amplification step).
Dees fails to teach: wherein the calculation is conducted by: establishing a calibration curve according to the following steps: preparing a plurality of standard solutions by dissolving the analyte into different predetermined concentrations; forming the sandwich structure in each of the standard solutions to obtain a plurality of secondary standards of the different predetermined concentrations; obtaining the first signals of each of the plurality of secondary standards to establish the calibration curve of relationship between the first signals and the different predetermined concentrations; and using the calibration curve to obtain the concentration of the analyte in the test solution based on the first signal obtained from the test solution.
Dees teaches sandwich type assays ([0017],[0035],[0115]). Dees teaches software saving internal standard data and sample data ([0361]). Dees teaches a sample can be dissolved to render it accessible to reagents used in an assay ([0178]).
Sakaki teaches a measurement method and reagent for cardiac troponin which enable accurate measurement of the amount of cardiac troponin in a sample irrespective to the type of the sample and the presence or absence of other components (abstract). Sakaki teaches immunoassay methods include a sandwich method for antibody reactions ([0033],[0035]). Sakaki teaches the sandwich method includes an anti-target-antigen antibody immobilized on a solid phase, a blocking treatment followed by reaction with a test sample containing a target antigen, washing, reaction with a labeled secondary antibody against the target antigen, washing, and then quantification of the label bound to the solid phase ([0038]). Sakaki teaches antigen standard solutions with various known concentrations are prepared, and the amount of the label immobilized on the solid phase is measured for each solution, followed by preparation of a calibration curve; wherein by measuring the amount of the label for an unknown test sample, and applying the measured amount of the label to the calibration curve, the amount of the antigen in the unknown test sample can be measured ([0038]). Sakaki teaches the sandwich method is well known in the art ([0038]).
Since Sakaki teaches sandwich type assays for measuring the amount of an analyte, similar to Dees, 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 method of Dees to incorporate Dees’ teachings of sandwich type assays ([0017],[0035],[0115]), saving internal standard data and sample data ([0361]), and dissolving a sample to render it accessible to reagents in an assay ([0178]) and Sakaki’s teachings of measuring the amount of an analyte in a sandwich method by preparing analyte standard solutions of known concentrations to prepare a calibration curve to apply to a measured amount of a label ([0038]) to provide: wherein the calculation is conducted by: establishing a calibration curve according to the following steps: preparing a plurality of standard solutions by dissolving the analyte into different predetermined concentrations; forming the sandwich structure in each of the standard solutions to obtain a plurality of secondary standards of the different predetermined concentrations; obtaining the first signals of each of the plurality of secondary standards to establish the calibration curve of relationship between the first signals and the different predetermined concentrations; and using the calibration curve to obtain the concentration of the analyte in the test solution based on the first signal obtained from the test solution. Doing so would have a reasonable expectation of successfully utilizing known methods of sandwich assays and preparing calibration curves to improve accuracy of measuring concentration of the analyte in an unknown sample irrespective to the type of the sample and the presence or absence of other components as taught by Dees.
Regarding claim 2, Dees further teaches wherein the plurality of nanoparticles are only composed of a single noble metal and do not have a core-shell structure (Fig. 6 and [0035] teaches a gold nanoparticle, which is interpreted as a single noble metal that does not have a core-shell structure).
Regarding claim 3, Dees further teaches wherein the optical waveguide element is selected from the group consisting of a cylindrical optical waveguide element, a planar optical waveguide element, a tubular optical waveguide element, and a grating waveguide element ([0306]-[0307] teaches the waveguide includes a planar optical waveguide element).
Regarding claim 4, Dees further teaches wherein the detection recognition element (Fig. 6 and [0035] teaches an “second antibody” bound to the agent and linked to a biotin tag) and the capture recognition element (Fig. 6 and [0035] teaches an antibody bound to the surface) are each independently selected from the group consisting of antibodies, peptides, hormone receptors, lectins, saccharides, chemical recognition molecules, deoxyribonucleic acid, ribonucleic acid, and aptamers (Fig. 6 and [0035] teach the detection recognition element and the capture recognition element are antibodies).
Regarding claim 7, Dees further teaches wherein the step of obtaining the first signal by using the photodetector comprises: irradiating a single-frequency light, a narrow-band light, or a white light to a proximal end or one side of the optical waveguide element to generate the evanescent wave energy ([0316] and [0369] teaching irradiating a waveguide through a side or end of the waveguide; [0126] teaches white light is used; [0221] teaches an excitation source with a single-frequency light, narrow band, or white light is used; [0262]-[0270] teaches a light beam is directed through the waveguide to create evanescent wave energy).
Regarding claim 10, Dees further teaches wherein the step of obtaining the first signal by using the photodetector comprises: irradiating the single-frequency light, the narrow-band light, or the white light to the proximal end of the optical waveguide element ([0316] and [0369] teaching irradiating a waveguide through a side or end of the waveguide; [0126] teaches white light is used; [0221] teaches an excitation source with a single-frequency light, narrow band, or white light is used; [0262]-[0270] teaches a light beam is directed through the waveguide to create evanescent wave energy) and placing the photodetector at a position facing the waveguide surface of the optical waveguide element to measure the evanescent wave energy corresponding to a variation of scattered light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal ([0352] teaches the detector is located perpendicular, i.e. facing, to an evanescent wave to measure a signal of light scattering; [0216] teaches that metal particles are detected and/or quantified by identifying each particle type by measuring intensity, i.e. variation, of their scattered light; [0264]-[0270] teaches evanescent wave is scattered by gold and is detected).
Regarding claim 11, Dees further teaches wherein the optical waveguide element comprises a plurality of sensing regions ([0162] teaches multiple sites; [0269] teaches a waveguide is illuminated to examine “all of the sites”).
Regarding claim 15, Dees further teaches wherein the photodetector is selected from the group consisting of photodiodes, phototransistors, phototubes, photomultipliers, photoconductors, metal-semiconductor-metal photodetectors, charged coupled devices, and complementary metal oxide semiconductor devices ([0252] teaches CCD; [0351] teaches photomultiplier tube, photodiode, and CMOS).
Regarding claim 17, Dees further teaches wherein the second anti-nonspecific adsorption layer comprises dextran ([0233] teaches the binding molecule is attached to the reactive surface through dextran).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Sakaki as applied to claim 1 above, and further in view of Xu et al. (US 2009148863 A1; cited in the IDS filed 06/27/2023).
Regarding claim 5, while Dees teaches spacers or linkers include polyethyleneglycols, dicarboxylic acids, polyamines and alkylenes or functional groups, for example hydrophilic groups such as amines, carboxylic acids and alcohols or lower alkoxy group such as methoxy and ethoxy groups ([0285]) and that binding molecules are attached to a particle through surface coatings comprising groups such as hydroxyl and carboxyl groups ([0194]), Dees fails to teach: wherein the first anti-nonspecific adsorption layer comprises: a first alkyl thiol self-assembling molecule with a carboxyl group (-COOH) or an amine group (-NH2) at a terminal thereof, and a second alkyl thiol self-assembling molecule selected from the group consisting of an alkyl thiol self-assembling molecule with a zwitterionic group at a terminal thereof, an alkyl thiol self-assembling molecule with a polyethylene glycol at a terminal thereof, and an alkyl thiol self-assembling molecule with a hydroxyl group (-OH) at a terminal thereof.
Xu teaches functionalized nanoparticles used for detection of analytes (abstract) wherein the nanoparticle (Fig. 1; “Ag”) comprises a first anti-nonspecific adsorption layer comprises a first alkyl thiol self-assembling molecule with a carboxyl group (-COOH) at a terminal thereof (Fig. 1 and [0144] teaches a “MUA” with a COOH end group; note that the instant application, specification, [0043] discloses MUA as an alkyl thiol self-assembling molecule) and a second alkyl thiol self-assembling molecule (Fig. 1;[0144], “MCH”; note that the instant application, specification, [0043] discloses MCH as an alkyl thiol self-assembling molecule) comprising an alkyl thiol self-assembling molecule with a hydroxyl group (-OH) at a terminal thereof (Fig. 1 and [0144] teach MCH comprises a hydroxyl terminal group). Xu teaches that having both MCH and MUA improves linkage to IgG ([0144]). Xu teaches that the ratio of MUA to MCH were important to prevent aggregation of nanoparticles ([0144]).
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 first anti-nonspecific adsorption layer of Dees to incorporate Dees’ teachings of spacers, linkers, and coatings including groups such as hydroxyl and carboxyl groups ([0194],[0285]) and Xu’s teachings of anti-nonspecific adsorption layers comprising a first and second alkyl thiol self-assembling molecules (Fig. 1; [0144]) to provide: wherein the first anti-nonspecific adsorption layer comprises: a first alkyl thiol self-assembling molecule with a carboxyl group (-COOH) or an amine group (-NH2) at a terminal thereof, and a second alkyl thiol self-assembling molecule selected from the group consisting of an alkyl thiol self-assembling molecule with a zwitterionic group at a terminal thereof, an alkyl thiol self-assembling molecule with a polyethylene glycol at a terminal thereof, and an alkyl thiol self-assembling molecule with a hydroxyl group (-OH) at a terminal thereof. Doing so would utilize known ways to functionalize nanoparticles, which would have a reasonable expectation of successfully improving linkage to a detection recognition element and prevent aggregation of nanoparticles, as taught by Xu, thus improving analysis.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Sakaki as applied to claim 1 above, and further in view of Quinn et al. (US 20030219753 A1; cited in the IDS filed 06/27/2023).
Regarding claim 6, while Dees teaches that a binding molecule is attached to a reactive surface through a dextran coating ([0233]), Dees fails to teach wherein the first anti-nonspecific adsorption layer comprises dextran.
Quinn teaches a surface plasmon resonance sensor biointerface with a thiol linker layer and interaction layer ligand and iron oxide nanoparticles (abstract). Quinn teaches the nanoparticles comprise a first anti-nonspecific adsorption layer comprises dextran to link the ligand of interest ([0063]).
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 first anti-nonspecific adsorption layer of Dees to incorporate Dees’ teachings of attaching a molecule via a dextran coating ([0233]) and Quinn’s teachings of dextran to link the ligand of interest ( [0063]) to provide wherein the first anti-nonspecific adsorption layer comprises dextran. Doing so would utilize known structures in the art that would have a reasonable expectation of successfully linking a detection recognition element to the nanoparticle as taught by Quinn.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Sakaki as applied to claim 7 above, and further in view of Sanders (US 20070147732 A1).
Regarding claim 8, Dees fails to explicitly teach wherein the single-frequency or the narrow-band light is an incident light having a fixed modulation frequency.
Sanders teaches a method of detecting particles with an optical waveguide with an evanescent tail of the lightwave extending there through extends into the environment and is reactive to at least one contaminant particle in the surrounding environment (abstract). Sanders teaches an optical resonant sensor uses a monochromatic or single frequency light source that may be static in time to be a fixed frequency light source , or it may scan frequencies over a period of time, where the frequency can be adjusted to the frequency desired for sensing ([0030]).
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 single-frequency or the narrow-band light of Dees to incorporate Sander’s teachings of optical waveguides for sensing that use fixed frequency of light ([0030]) to provide: wherein the single-frequency or the narrow-band light is an incident light having a fixed modulation frequency. Doing so would have a reasonable expectation of successfully improving control of the light frequency desired for sensing as taught by Sanders ([0030]).
Claim 9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Sakaki as applied to claim 7 above, and further in view of Tono et al. (US 20120252111 A1; cited in the IDS filed 06/27/2023).
Regarding claim 9, Dees further teaches wherein the step of obtaining the first signal by using the photodetector comprises: irradiating the single-frequency light, the narrow-band light, or the white light to the proximal end of the optical waveguide element ([0316] and [0369] teaching irradiating a waveguide through a side or end of the waveguide; [0126] teaches white light is used; [0221] teaches an excitation source with a single-frequency light, narrow band, or white light is used; [0262]-[0270] teaches a light beam is directed through the waveguide to create evanescent wave energy).
While Dees teaches that a detector can be located approximately perpendicular, parallel, or not parallel with an evanescent wave ([0352]), Dees fails to teach: placing the photodetector at a distal end of the optical waveguide element to measure the evanescent wave energy corresponding to a variation of transmitted light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal.
Tono teaches a measuring system using an optical waveguide (abstract). Tono teaches a step of obtaining a first signal by using the photodetector comprises: irradiating the single-frequency light, the narrow-band light, or the white light to the proximal end of the optical waveguide element (Fig. 1 and [0059] teach irradiating a red light to the proximal end, interpreted as the area where element 2a is, of optical waveguide 3) and placing the photodetector at a distal end of the optical waveguide element (Fig. 1 shows photodetector 8 at the distal end, interpreted as the right side of waveguide 3 where the light is outputted from element 2b) to measure the evanescent wave energy corresponding to a variation of transmitted light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal ( [0085] teach evanescent light is generated and the magnetic fine particles contribute to absorbing or scattering of the evanescent light, where an intensity of a reflected light is attenuated, and the light outputted is obtained by light receiving element 8; the outputted light is interpreted as the transmitted light).
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 photodetector of Dees to incorporate the teachings of positioning of a photodetector in relation to an optical waveguide of Tono (Fig. 1) to provide: placing the photodetector at a distal end of the optical waveguide element to measure the evanescent wave energy corresponding to a variation of transmitted light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal. Doing so would utilize known positioning of photodetectors in the art, as taught by Tono, which would have a reasonable expectation of successfully measuring absorbing or scattering of evanescent light. Furthermore, doing so would have been a rearrangement of parts (see MPEP 2144.04 (VI)(C)), wherein the particular placement of the photodetector would be an obvious matter of design choice in view of Dees and Tono.
Regarding claim 12, Dees further teaches wherein the step of obtaining the first signal by using the photodetector comprises: irradiating the single-frequency light, the narrow-band light, or the white light to the one side of the optical waveguide element ([0316] and [0369] teaching irradiating a waveguide through a side or end of the waveguide; [0126] teaches white light is used; [0221] teaches an excitation source with a single-frequency light, narrow band, or white light is used; [0262]-[0270] teaches a light beam is directed through the waveguide to create evanescent wave energy) and placing the photodetector at a position facing the waveguide surface of the optical waveguide element to measure the evanescent wave energy ([0352] teaches the detector is located perpendicular, i.e. facing, to an evanescent wave to measure a signal of light scattering; [0216] teaches that metal particles are detected and/or quantified by identifying each particle type by measuring intensity of their scattered light; [0264]-[0270] teaches evanescent wave is scattered by gold and is detected).
Dees fails to teach: placing the photodetector at a position facing the waveguide surface of the optical waveguide element to measure the evanescent wave energy corresponding to a variation of diffracted light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal, wherein the photodetector and the light source can be on the same side or opposite side of the waveguide surface of the optical waveguide element.
Tono further teaches obtaining a first signal by using the photodetector (Fig. 1 teaches a photodetector 8 receiving a signal from the optical waveguide 3) comprises: irradiating the single-frequency light, the narrow-band light, or the white light to the one side of the optical waveguide element (Fig. 1 and [0092] teaches light emitting diode 7 emits a light having a central wavelength of 635 nm to a side of optical waveguide 3) and placing the photodetector at a position facing the waveguide surface of the optical waveguide element (Fig. 1 teaches a photodetector 8 facing the waveguide surface of optical waveguide element 3) to measure the evanescent wave energy corresponding to a variation of diffracted light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal (Figs. 3A-3C and [0085] teach particles reaching a region where evanescent light is present, i.e. evanescent field, and diffracted light intensity is measured, i.e. laser light outputted from grating 2b), wherein the photodetector and the light source can be on the same side or opposite side of the waveguide surface of the optical waveguide element (Fig. 1).
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 photodetector of Dees to incorporate the teachings of positioning a photodetector in relation to an optical waveguide to evanescent wave energy corresponding to diffracted light of Tono (Figs. 1, 3A-3C; [0085],[0092]) to provide: placing the photodetector at a position facing the waveguide surface of the optical waveguide element to measure the evanescent wave energy corresponding to a variation of diffracted light intensity when the plurality of nanoparticles approach an evanescent field of the optical waveguide element as the first signal, wherein the photodetector and the light source can be on the same side or opposite side of the waveguide surface of the optical waveguide element. Doing so would utilize known positioning of photodetectors in the art, as taught by Tono, which would have a reasonable expectation of successfully measuring variation of diffracted light intensity of the nanoparticles for proper sample analysis. Furthermore, doing so would have been a rearrangement of parts (see MPEP 2144.04 (VI)(C)), wherein the particular placement of the photodetector would be an obvious matter of design choice in view of Dees and Tono.
Regarding claim 13, Dees fails to teach: wherein the optical waveguide element is a grating waveguide element.
Tono further teaches an optical waveguide element is a grating waveguide element (Fig. 1 teaches the optical waveguide 3 comprises grating waveguide elements 2a and 2b). Tono teaches gratings allow for a means for light to enter and exit the optical waveguide ([0060]).
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 optical waveguide element of Dees to incorporate the Tono’s teachings of an optical waveguide with gratings (Fig. 1; [0060]) to provide: wherein the optical waveguide element is a grating waveguide element. Doing so would utilize known structures in the art which would have a reasonable expectation of successfully improving input and output of light to the waveguide element.
Regarding claim 14, modified Dees further teaches wherein the grating waveguide element comprises a plurality of sensing regions (Dees, [0162] teaches multiple sites; [0269] teaches a waveguide is illuminated to examine “all of the sites).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dees in view of Sakaki as applied to claim 1 above, and further in view of Ewart et al. (US 5922537 A; cited in the IDS filed 06/27/2023) and Blair et al. (US 20160355869 A1; cited in the IDS filed 06/27/2023).
Regarding claim 16, while Dees teaches that binding molecules are covalently attached to a reactive surface through chemical means, such as chemically reactive groups, polymers, hydroxyl and siloxy groups, linkers, or 3-aminopropyltriethoxysilane ([0233]), Dees fails to explicitly teach: wherein the second anti-nonspecific adsorption layer comprises: a first alkyl silane self-assembling molecule with a carboxyl group (-COOH) or an amine group (-NH2) at a terminal thereof, and a second alkyl silane self-assembling molecule selected from the group consisting of an alkyl silane self-assembling molecule with a zwitterionic group at a terminal thereof, an alkyl silane self-assembling molecule with a polyethylene glycol at a terminal thereof, and an alkyl silane self-assembling molecule with a hydroxyl group (-OH) at a terminal thereof.
Ewart teaches a biosensor (Fig. 9; abstract) comprising a capture recognition element (32) conjugated on a waveguide surface of an optical waveguide element (Fig. 9 shows element 32 conjugated on waveguide 116) through a second anti-nonspecific adsorption layer (column 4, lines 45-46 teach the recognition molecules 32 are inked to the surface by linkers 34) wherein the second anti-nonspecific adsorption layer comprises an alkyl silane self-assembling molecule with a carboxyl group (-COOH) or an amine group (-NH2) at a terminal thereof (column 7 teaches the linkers comprises amino- or thiol-terminal silanes).
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 second anti-nonspecific adsorption layer of Dees to incorporate the teachings of Ewart to provide wherein the second anti-nonspecific adsorption layer comprises: a first alkyl silane self-assembling molecule with a carboxyl group (-COOH) or an amine group (-NH2) at a terminal thereof. Doing so would utilize known silane molecules in the art, as taught by Ewart, which would have a reasonable expectation of successfully fixing the first substance to the optical waveguide.
Modified Dees fails to teach the second anti-nonspecific adsorption layer comprising a second alkyl silane self-assembling molecule selected from the group consisting of an alkyl silane self-assembling molecule with a zwitterionic group at a terminal thereof, an alkyl silane self-assembling molecule with a polyethylene glycol at a terminal thereof, and an alkyl silane self-assembling molecule with a hydroxyl group (-OH) at a terminal thereof.
Blair teaches devices and methods related to biological assays (abstract), wherein the assay may comprise an irradiating a waveguide, wherein an evanescent field is generated, and molecules that are immobilized are excited, such as a sandwich-type assay ([0064]). Blair teaches capture molecules are attached to the bottom of nanocavities while exposed surfaces are passivated with an alkyl silane self-assembling molecule with a polyethylene glycol to prevent molecules to adhere to the surface ([0077]).
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 second anti-nonspecific adsorption layer of modified Dees to incorporate Blair’s teachings of attachment of molecules with an alkyl silane self-assembling molecule with a polyethylene glycol ([0064],[0077]) to provide: the second anti-nonspecific adsorption layer comprising a second alkyl silane self-assembling molecule including an alkyl silane self-assembling molecule with a polyethylene glycol at a terminal thereof. Doing so would utilize known surface modifications, as taught by Blair, which would have a reasonable expectation of successfully preventing unwanted molecules to adhere to the surface of the waveguide (Blair, [0077]).
Response to Arguments
Applicant’s arguments, see page 7, filed 09/04/2026, with respect to rejections under 35 U.S.C. 101 have been fully considered and are persuasive. The rejections under 35 U.S.C. 101 of 06/05/2026 have been withdrawn.
Applicant’s arguments, see pages 7-9, filed 09/04/2026, with respect to the rejections of claims 1-4, 7, 10-11, 15, and 17 under 35 U.S.C. 102(a)(2) and claims 5-6, 8-9, 12-14, and 16 under 35 U.S.C. 103, specifically regarding amended claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dees et al. (US 20100285490 A1; cited in the IDS filed 06/27/2023) in view of Sakaki et al. (US 20210215680 A1; effectively filed 09/13/2016).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tetsumoto et al. (US 20150316541 A1) teaches a means that enables an immunoassay of hemoglobin A1c in a whole blood sample (abstract). Tetsumoto teaches HbA1c is measured by a sandwich method ([0021]); wherein standard samples with known HbA1c concentrations are subjected to the measurement, and the relationship between the signal intensities and the HbA1c concentrations is plotted to prepare a calibration curve; wherein by applying the measured value of a whole blood sample to this calibration curve, the amount of HbA1c in the whole blood sample can be quantified ([0021]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
