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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/27/2025 has been entered.
Election/Restrictions
Newly submitted claims 21-23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions II (claims 21-23) and II (claims 1-8) are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because claim 21 does not require: the immuno-chromatographic diagnosis system being configured to: select, from the plurality of distinct and known recovery locations of the solid support, a subset of the plurality of the distinct and known recovery locations to be detected and/or quantified; identifies a distinct one of the analytes in the migration direction; calculate from the data related to light intensities coming from the subassemblies, for each subassembly that corresponds to at least one of the subset of the plurality of the distinct and known recovery locations on the solid support, a subassembly intensity; determine, based on the subassembly intensity, information for the at least one of the subset of the plurality of different analytes in the liquid sample; and transmit information for each subassembly corresponding to at least one of the plurality of different analytes of the liquid sample. The subcombination has separate utility such as selecting a subset of recovery locations.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The Amendment filed 10/27/2025 has been entered. Claims 1-8, 10-12, 14-19, and 21-23 remain pending in the application. Claims 10-12, 14-19, and 21-23 are withdrawn.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 20150087543 A1, cited in the IDS filed 02/27/2024) in view of Obremski et al. (US 6110749 A) in view of Polito et al. (US 20040018637 A1) and O’Farrell et al. (US 20120184462 A1; cited in the IDS filed 02/27/2024).
Regarding claim 1, Rao teaches a diagnosis kit (abstract; Figs. 19-20) for simultaneously and specifically detecting a plurality of different analytes present in a liquid sample (interpreted as an intended use, see MPEP 2114; abstract, Figs. 19-20 and paragraph [0233] teaches a lateral flow assay for multiplexed detection in a fluid sample using different capture molecules; paragraph [0087] teaches each distinct capture molecule recognizes a different biomarker), the diagnosis kit comprising an immuno-chromatographic diagnosis system (Figs. 19-20 and paragraph [0233] teaches a lateral flow assay for multiplexed detection in a fluid sample with fluorescence; paragraph [0055] teaches the device is a channel flow based immunoassay detection device), the immuno-chromatographic diagnosis system being a lateral flow system (Figs. 19-20 and paragraph [0233]) and comprising:
(i) a plurality of diagnosis couples (Fig. 19 and paragraph [0233] teaches multiple capture molecules and fluorescent QD nanocrystals), wherein each of the plurality of diagnosis couples is specific for binding at least one of the plurality of different analytes present in the liquid sample (paragraph [0233] and [0010] teach a plurality of distinct capture molecule groups, each distinct capture molecule group including a plurality of capture molecules specific for a biomarker) and consists of (a) a recognition biological molecule (paragraph [0233] and [0010], capture molecule), wherein the recognition biological molecule is bonded to a distinct and known recovery location on a solid support (Fig. 19 and paragraph [0233] teach the capture molecules spotted onto a nitrocellulose membrane);
(ii) at least one recovery system comprising the solid support (Fig. 19 and paragraph [0233], nitrocellulose membrane), the solid support comprising a porous membrane (paragraphs [0233]-[0234], nitrocellulose) configured to cause a reacted liquid sample produced by an interaction of the at least one reaction mixture with the liquid sample to flow in a migration direction (interpreted as a functional limitation, see MPEP 2114; Fig. 19 and paragraph [0234] teaches the nitrocellulose allows for a mixture to flow in a direction), the solid support comprising a plurality of the distinct and known recovery locations on the porous membrane (Fig. 19 and paragraph [0233], multiple capture spots) each being configured to identify a distinct one of the analytes in the migration direction (paragraphs [0233]-[0235] teaches multiplexed detection in the lateral flow format; paragraph [0087] teaches each distinct capture molecule recognizes a different biomarker), wherein the plurality of distinct and known recovery locations are arranged on the porous membrane according to a two-dimensional matrix arrangement (Fig. 19) to enable simultaneous and specific identification of the plurality of different analytes present in the liquid sample based on localization of each of the plurality of distinct and known recovery locations on the porous membrane (interpreted as an intended use, MPEP 2114; Fig. 19 and paragraph [0087] teaches multiple capture spots for detecting different biomarkers, therefore is structurally capable of enabling simultaneous and specific identification of the biomarkers based on their locations; paragraph [0065] teaches array formats use spatial location to identify the feature present at that location); wherein:
the two-dimensional matrix arrangement (Figs. 19-20) is defined according to a system of coordinates comprising a first coordinate (X) (Figs. 19-20, interpreted as the direction of flow, i.e. row) and a second coordinate (Y) (Figs. 19-20, interpreted as the direction perpendicular of flow, i.e. column), wherein for a given coordinate X, the plurality of distinct and known recovery locations along Y corresponds to a first plurality of the diagnosis couples (Fig. 20 and paragraph [0234] teaches a column of three spots corresponds to biotin-BSA, and a different column of three spots corresponds to mouse IgG); wherein each of the plurality of the distinct and known recovery locations on the solid support correspond to detection of at least one of the plurality of different analytes in the liquid sample (paragraphs [0233]-[0235] teaches multiplexed detection in the lateral flow format; paragraph [0087] teaches each distinct capture molecule recognizes a different biomarker);
(iii) wherein a reacted liquid sample is produced by an interaction of the at least one reaction mixture with the liquid sample (paragraphs [0078]-[0080] teaches a fluid mixture comprising a sample and reagents, and the fluid mixture is added to the device), wherein the solid support (Fig. 19 and paragraphs [0233]-[0234], nitrocellulose) is configured for contact with the reacted liquid sample for immuno-chromatographic analysis of the reacted liquid sample (interpreted as a functional limitation, see MPEP 2114; Figs. 19-20 and paragraphs [0080] and [0233]-[0234] teaches a fluid mixture comprising a sample is added to the nitrocellulose for fluorescence analysis of biomarkers; paragraph [0055] teaches channel flow based immunoassay detection); and
(iv) an optical device (Fig. 2 and paragraphs [0227]-[0229] teaches an imaging system) configured for optically reading at least part of the solid support (Fig. 2 and paragraphs [0227]-[0229], [0235]), the optical device comprising:
(a) a placement (Fig. 2, positioning stage) configured to receive the at least part of the solid support (Fig. 2);
(b) an optical unit (Fig. 2 and paragraph [0229], interpreted as a lamp, filter, lens, and camera) configured to analyze the solid support (Fig. 2 and paragraph [0229]), wherein the optical unit comprises:
a first light source (Fig. 2 and paragraph [0229], xenon arc lamp) configured to emit a first light beam to the placement according to an emission intensity and a first wavelength range (Fig. 2 and paragraph [0229]);
an imaging system comprising an optical detector (Fig. 2 and paragraph [0229], CCD camera) configured to provide an image of a visualization zone (Fig. 2 and paragraphs [0229],[0235] teaches imaging the microarray, therefore is configured to provide an image of a visualization zone on the stage), wherein the visualization zone comprises at least a portion of the placement (Fig. 2 shows imaging of a zone on the positioning stage); and
a filter positioned between the placement and the imaging system (Fig. 2, emission filter) and configured to filter a defined wavelength range (Fig. 2 and paragraph [0229]);
the immuno-chromatographic diagnosis system being configured to:
provide data related to light intensities coming from the subassemblies (paragraph [0234] and Fig. 20 teaches imaging and observing signal intensity of the multiplexed lateral flow assay; therefore, the system is configured to provide data related to light intensities from subassemblies).
Rao fails to teach: wherein each of the plurality of diagnosis couples consists of (b) a competitive ligand, labeled with at least one visualization molecule detectable with fluorescence, and wherein the recognition biological molecule is disposed in a reaction mixture and the competitive ligand is bonded to a distinct and known recovery location on a solid support, or vice versa; and for a given coordinate Y, the plurality of recovery locations along X corresponds to a second plurality of the diagnosis couples; (iii) at least one container comprising the reaction mixture, wherein the at least one container comprising the reaction mixture is separated from the solid support; the immuno-chromatographic diagnosis system being configured to: select, from the plurality of distinct and known recovery locations of the solid support, a subset of the plurality of the distinct and known recovery locations to be detected and/or quantified; process an image of the visualization zone to determine a finite number of subassemblies of the image, wherein each subassembly corresponds to one of the subset of the plurality of the distinct and known recovery locations on the porous membrane and identifies a distinct one of the analytes in the migration direction; provide data related to light intensities coming from the subassemblies; calculate from the data related to light intensities coming from the subassemblies, for each subassembly that corresponds to at least one of the subset of the plurality of the distinct and known recovery locations on the solid support, a subassembly intensity; determine, based on the subassembly intensity, information for the at least one of the subset of the plurality of different analytes in the liquid sample; and transmit information for each subassembly corresponding to at least one of the plurality of different analytes of the liquid sample.
Rao teaches known devices for processing a number of different biomarkers, such as competitive immunochromatographic assays (paragraph [0007]). Rao teaches capture molecules including antibodies and the liquid mixture includes the sample, at least one detector antibody, and at least one fluorescent reporter (paragraph [0016]). Rao teaches for immunoassay, capture molecules are immobilized on a support and a capture molecule can be labeled, e.g., a fluorescently labeled antibody or protein (paragraph [0060]). Rao teaches often the fluid mixture includes additional reagents, e.g., detection antibodies, for detection of the biomarkers bound to the capture molecules immobilized on the solid support; and the detection antibodies can be labeled for detection, e.g., fluorescently labeled (paragraph [0079]).
Obremski teaches a diagnosis kit (abstract; Figs. 1-5) for simultaneously and specifically detecting a plurality of different analytes present in a liquid sample (abstract; column 7, lines 6-8, teaches “liquid samples” and “multiple target analytes”). Obremski teaches for quantitative analysis, a known quantity of an analog of the target analyte can be applied to the detector for a competitive assay (column 2, lines 52-55). Obremski teaches a diagnosis couple (column 5, lines 21-24 teaches an analog that competes with target analyte to bond to the probe; column 17, lines 29-33 teaches an antibody and analog, i.e. diagnosis couple), wherein the diagnosis couple is specific for binding at least one of the plurality of different analytes present in the liquid sample (column 5, lines 21-24 teaches an analog that competes with target analyte to bond to the probe, i.e. specific for binding an analyte; column 17, lines 34-41 teaches measuring signals of a target analyte; thus, the couple is specific for binding an analyte) and consists of (a) a recognition biological molecule (column 17, lines 29-30 teaches an antibody, i.e. recognition biological molecule); and (b) a competitive ligand (column 17, lines 31-33, “analog”; column 5, lines 21-24 teaches an analog that competes with target analyte to bond to the probe), labeled with at least one visualization molecule detectable with fluorescence (column 17, lines 29-33 teaches an antibody, i.e. recognition biological molecules, having an attached fluorophore, i.e. visualization molecule detectable with fluorescence), and wherein the recognition biological molecule is disposed in a reaction mixture (column 17, lines 29-31 teaches an antibody and analog are used to treat a sample, thus the antibody, i.e. recognition biological molecule, is interpreted as disposed in a reaction mixture comprising the antibody and sample) and the competitive ligand is bonded to a distinct and known recovery location on a solid support (column 17, lines 33-40 teaches the analog, i.e. competitive ligand, attaches to avidin on the waveguide, i.e. is bonded to a distinct and known recovery location). Obremski teaches screening samples for a selected target analyte (column 2, lines 16-17), introducing light at a plurality of selected locations (column 2, lines 44-47), a plurality of different probes having specific binding partners applied in discrete areas (column 3, line 66 - column 4, line 7), a diagnosis couple (column 5, lines 21-24 teaches an analog that competes with target analyte to bond to the probe; column 17, lines 29-33 teaches an antibody and analog), associating different light responsive compounds with different probes and samples to analyze multiple samples (column 11, lines 34-50), results detected were displayed on a computer monitor (column 17, lines 11-15), and analyzing strength of an emitted signal (column 17, lines 38-40 teaches the more target analyte present, the less analog binds, and the weaker the emitted signal).
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 diagnosis couple and distinct and known recovery locations of Rao to incorporate Rao’s teachings of competitive immunochromatographic assays and fluorescent labels for detection of biomarkers (paragraphs [0007],[0016],[0060],[0079]) and Obremski’s teachings of different probes having specific binding partners applied in discrete areas (column 3, line 66 - column 4, line 7), a diagnosis couple (column 5, lines 21-24 teaches an analog that competes with target analyte to bond to the probe; column 17, lines 29-33 teaches an antibody and analog), and associating different light responsive compounds with different probes and samples to analyze multiple samples (column 11, lines 34-50) to provide: wherein each of the plurality of diagnosis couples consists of (b) a competitive ligand, labeled with at least one visualization molecule detectable with fluorescence, and wherein the recognition biological molecule is disposed in a reaction mixture and the competitive ligand is bonded to a distinct and known recovery location on a solid support, or vice versa; and for a given coordinate Y, the plurality of recovery locations along X corresponds to a second plurality of the diagnosis couples. Doing so would have a reasonable expectation of successfully improving versatility of the overall kit by employing multiple diagnosis couples at different locations to analyze different analytes (Obremski, column 11, lines 26-50).
Modified Rao fails to teach: (iii) at least one container comprising the reaction mixture, wherein the at least one container comprising the reaction mixture is separated from the solid support; the immuno-chromatographic diagnosis system being configured to: select, from the plurality of distinct and known recovery locations of the solid support, a subset of the plurality of the distinct and known recovery locations to be detected and/or quantified; process an image of the visualization zone to determine a finite number of subassemblies of the image, wherein each subassembly corresponds to one of the subset of the plurality of the distinct and known recovery locations on the porous membrane and identifies a distinct one of the analytes in the migration direction; provide data related to light intensities coming from the subassemblies; calculate from the data related to light intensities coming from the subassemblies, for each subassembly that corresponds to at least one of the subset of the plurality of the distinct and known recovery locations on the solid support, a subassembly intensity; determine, based on the subassembly intensity, information for the at least one of the subset of the plurality of different analytes in the liquid sample; and transmit information for each subassembly corresponding to at least one of the plurality of different analytes of the liquid sample.
Obremski teaches screening samples for a selected target analyte (column 2, lines 16-17), introducing light at a plurality of selected locations (column 2, lines 44-47), and a plurality of different probes having specific binding partners applied in discrete areas (column 3, line 66 - column 4, line 7). Obremski’s teaches displaying results on a computer monitor (column 17, lines 11-15).
Polito teaches a method and apparatus for performing and analyzing a lateral flow assay, and determining an amount of analyte present in a sample (paragraph [0002]), comprising detecting signals from detection zones on a test strip (abstract). Polito teaches a communication system configured to: obtain an item of information relative to a solid support (paragraph [0031] teaches a computer system is coupled to an input device, such as a keyboard; paragraph [0054] teaches a processor receives parameters or prompts from a keyboard or other suitable device, wherein the processor receives parameters to execute an algorithm for controlling and analyzing the assay, i.e. which would information relative to a solid support since the analysis is relative to the test strip). Polito teaches parameters and fields are stored in a memory and includes fields grouped into tables, for performing an algorithm to analyze and interpret results of an assay, which may be selected according to the particular assay being performed (paragraph [0067]). Polito teaches a field identifies the locations or relative positions of measurement zones on a test strip, wherein the zones may be selected to correspond to either analyte binding zones or control bonding zones (paragraph [0069]). Polito teaches the ability of a reader to allow for selection of the position of zones to optimize the relative position of zones, since they may differ from assay to assay (paragraph [0069]). Polito teaches the ability to select or predetermine the method for interpreting any particular assay further enhances the flexibility provided to the user by the reader (paragraph [0073]). Polito teaches an image processing system (paragraph [0059] teaches multiple array optical sensors, such as cameras and CCD arrays are employed). Polito teaches locating boundaries of measurement zones (paragraphs [0015], [0069]). Polito teaches calculating and determining intensity of analyte binding zones (paragraph [0083]). Polito teaches determining analyte information, such as concentration values of analytes based on the relative intensity of the measurement zones (paragraphs [0047],[0049]). Polito teaches a transmission system configured to transmit information for each subassembly corresponding to at least one of the plurality of different analytes of the liquid sample (paragraph [0054] teaches the processor comprises an infrared port for transferring information from a reader to an external computer; thus, the port is capable of transmitting information at a later time). Polito teaches each detection zone is preferably located such that an automatic or semi-automatic analytical instrument, or a human reader, may determine certain results of the lateral flow assay (paragraph [0050]). Polito teaches readers provide an improvement in that they may analyze an assay result, thereby removing subjective factors that cause human error (paragraph [0007]). Polito teaches the ability of the reader to allow for selection of the position of the measurement zones for the control binding zones and analyte binding zones is particularly advantageous, since the presence of an upstream measurement zone may affect the chemical constituency of a downstream measurement zone during lateral flow (paragraph [0069]). Polito teaches uploading or downloading software to and from a computer system within a reader to perform an assay and analyzing and interpreting results of the assay (paragraph [0031]).
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 diagnosis kit of modified Rao to incorporate Polito’s teachings of a computer system coupled to an input device to receive parameters (paragraphs [0031],[0054]), and selection of the position of zones to optimize the relative position of zones (paragraph [0069]) and Obremski’s teachings of screening samples for a selected target analyte (column 2, lines 16-17), introducing light at a plurality of selected locations (column 2, lines 44-47), and a plurality of different probes having specific binding partners applied in discrete areas (column 3, line 66 - column 4, line 7) to provide: the immuno-chromatographic diagnosis system being configured to: select, from the plurality of distinct and known recovery locations of the solid support, a subset of the plurality of the distinct and known recovery locations to be detected and/or quantified. Doing so would have a reasonable expectation of successfully improving inputting and optimizing proper location information of the different probes of Rao and improving selection capability to allow for proper analysis of a desired selected target analyte, thus overall improving workflow and accuracy of the overall kit comprising the diagnosis system.
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 diagnosis kit of modified Rao to incorporate Polito’s teachings of identifying the locations or relative positions of measurement zones on a test strip (paragraph [0069]), locating boundaries of measurement zones (paragraphs [0015],[0069]), calculating and determining intensity of analyte binding zones (paragraph [0083]), and determining analyte information of measurement zones (paragraphs [0047],[0049]), and Obremski’s teachings of analyzing strength of an emitted signal of (column 17, lines 38-40 teaches the more target analyte present, the less analog binds, and the weaker the emitted signal) to provide: the immuno-chromatographic diagnosis system being configured to: process an image of the visualization zone to determine a finite number of subassemblies of the image, wherein each subassembly corresponds to one of the subset of the plurality of the distinct and known recovery locations on the porous membrane and identifies a distinct one of the analytes in the migration direction; provide data related to light intensities coming from the subassemblies; calculate from the data related to light intensities coming from the subassemblies, for each subassembly that corresponds to at least one of the subset of the plurality of the distinct and known recovery locations on the solid support, a subassembly intensity; determine, based on the subassembly intensity, information for the at least one of the subset of the plurality of different analytes in the liquid sample. Doing so would utilize known structures and methods of identifying zones for measurements to improve automation, analysis, and characterization of emitted signals of discrete areas comprising different probes with a reasonable expectation of success.
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 diagnosis kit of modified Rao to incorporate Polito’s teachings of a port for transferring information between elements (paragraph [0054]) and Obremski’s teachings of displaying results on a computer monitor (column 17, lines 11-15) to provide: the immuno-chromatographic diagnosis system being configured to: transmit information for each subassembly corresponding to at least one of the plurality of different analytes of the liquid sample. Doing so would utilize known structures in the art for transferring information, which would have a reasonable expectation of successfully allowing transferring or transmission of analysis data and thus, allow for displaying or further analysis of data.
Modified Rao fails to teach: (iii) at least one container comprising the reaction mixture, wherein the at least one container comprising the reaction mixture is separated from the solid support.
Rao teaches a fluid mixture including a sample, a detector antibody, and fluorescent reporter is applied to the array (paragraphs [0018],[0079]-[0080]).
O’Farrell teaches a device for detecting an analyte comprising a two-dimensional array of reagents (abstract; paragraph [0011]), wherein the device comprises nitrocellulose (paragraph [0016]) and reagent dots having a diameter of 301-400 um. O’Farrell teaches a liquid sample and reagent is premixed and applied to a test device (paragraph [0143]). O’Farrell teaches an example where a labeled reagent can be dried in a location or container not in fluid communication with the test device and in use, the sample liquid can be added to the container to form the mixture and the mixture can then be applied to the test device (paragraph [0143]).
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 reaction mixture of modified Rao to incorporate the teachings of mixing a reagent and sample in a container separately from a test device of O’Farrell (paragraph [0143]) and applying a fluid mixture to an array of Rao (paragraphs [0018],[0079]-[0080]) to provide: (iii) at least one container comprising the reaction mixture, wherein the at least one container comprising the reaction mixture is separated from the solid support. Doing so would have a reasonable expectation of successfully allowing for combining and reacting a mixture prior to applying to a testing device as taught by O’Farrell (paragraph [0143]).
Regarding claim 2, Rao further teaches wherein the plurality of the distinct and known recovery locations in the two-dimensional matrix arrangement are in the form of points (Fig. 19, capture spots), each having a diameter of between 20 um to 2 mm, between 100 to 500 um, or between 250 and 400 um (paragraph [0213] teaches the diameter of spots was 0.5 mm).
Regarding claim 3, Rao further teaches wherein the solid support comprises: at least 5 distinct and known recovery locations (Fig. 19 shows at least 5 capture spots) that respectively, simultaneously, and specifically detect and/or quantify at least 5 distinct analytes of the plurality of different analytes present in the liquid sample (paragraph [0087] teaches capture molecules that recognize a different biomarkers, and includes at least 5 distinct capture molecules).
Modified Rao fails to explicitly teach at least one recovery location configured as a control and/or calibrator location.
Rao teaches spots can be used as position controls and reference points when slides are imaged (paragraph [0152]). Rao teaches a multiplexed capture antibody assay including two control molecules including a negative control and positive control (paragraph [0189]).
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 distinct and known recovery locations to incorporate the teachings of spots as controls or reference points of Rao (paragraphs [0152],[0189]) to provide: at least one recovery location configured as a control and/or calibrator location. Doing so would have a reasonable expectation of successfully improving validation of an assay and improving location referencing of an image.
Regarding claim 4, Rao further teaches wherein the solid support comprises a membrane or a set of membranes (Fig. 19 shows the nitrocellulose membrane and/or polystyrene backing).
Regarding claim 5, modified Rao fails to explicitly teach: wherein the at least one visualization molecule detectable with fluorescence are fused to the recognition biological molecules and/or to the competitive ligands via a chemical and/or genetic coupling.
Rao teaches detection antibodies can be labeled for detection (paragraph [0079]) and an optical reader that detects the fluorescently labeled detection antibodies bound to the biomarkers bound to the capture molecules immobilized to the array (paragraph [0080]). Rao teaches linking of capture molecules can be covalent or noncovalent (paragraph [0083]).
Obremski teaches at least one visualization molecule detectable with fluorescence are fused to the recognition biological molecules and/or to the competitive ligands (column 17, lines 29-33 teaches an antibody, i.e. recognition biological molecules, having an attached fluorophore, visualization molecule detectable with fluorescence and an analog, i.e. competitive ligands, with an amount of labelled antibody) via a chemical and/or genetic coupling (column 17, lines 29-33 teaches fluorophore is attached to the antibody and an analog with an amount of labelled antibody, thus, “attached” implies a chemical or genetic coupling; column 8, lines 1-16 teaches fluorophores with a carboxyl acid tail for conjugation, i.e. chemical coupling; column 11, lines 20-25 teaches a fluorophore bonded to amino or other nucleophilic groups using a coupling agent).
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 at least one visualization molecule and the recognition biological molecules and/or to the competitive ligands of modified Rao to incorporate Rao’s teachings of fluorescently labeled molecules and covalent or noncovalent linking of molecules (paragraphs [0079]-[0080],[0083]) and the teachings of a fluorophore attached to an antibody of Obremski (column 17, lines 29-33; column 11, lines 20-25) to provide: wherein the at least one visualization molecule detectable with fluorescence are fused to the recognition biological molecules and/or to the competitive ligands via a chemical and/or genetic coupling. Doing so would have a reasonable expectation of successfully attaching or labeling the recognition biological molecules and/or to the competitive ligands with desired visualization molecules for fluorescence analysis.
Regarding claim 6, modified Rao fails to explicitly teach: wherein the chemical and/or genetic coupling is performed via at least one electrostatic force, at least one peptide bond, at least one reporter gene, or any combination thereof.
Obremski teaches fluorophores with a carboxyl acid tail for conjugation (column 8, lines 1-16) and a fluorophore bonded to amino or other nucleophilic groups using a coupling agent (column 11, lines 20-25), thus, a fluorophore with a carboxyl acid tail that is bonded to amino group would be a peptide bond, wherein a peptide bond is a chemical bond formed between a carboxyl group of one molecule with an amino group of another molecule.
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 chemical and/or genetic coupling of modified Rao to incorporate Obremski’s teachings of conjugation of fluorophores (column 8, lines 1-16; column 11, lines 20-25) to provide wherein the chemical and/or genetic coupling is performed via at least one electrostatic force, at least one peptide bond, at least one reporter gene, or any combination thereof. Doing so would have a reasonable expectation of successfully attaching or labeling the recognition biological molecules and/or to the competitive ligands with desired visualization molecules for fluorescence analysis.
Regarding claim 7, modified Rao fails to teach: wherein the plurality of different analytes in the liquid sample are selected from the group consisting of: drug residues, toxins, viruses, bacteria, hormones, heavy metals, adulterants, allergens, a mixture thereof, and any combination thereof.
Rao teaches known lateral flow assays for detection of bacteria and toxins (paragraph [0008]). Rao teaches capture molecules specific for biomarkers associated with influenza, plague, anthrax, and allergens (paragraph [0093]). Rao teaches the device provides the ability to perform multiplexed analysis of multiple biomarkers in a format that is simple to use, amenable to automation, and in a small, rugged format (paragraph [0056]).
Obremski teaches target analytes can include hormones, illicit drugs, cancer related molecules, toxins, antibodies to viruses and diseases (column 14, lines 35-54).
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 plurality of different analytes in the liquid sample of modified Rao to incorporate Rao’s teachings of multiplexed analysis (paragraphs [0056]) and known detection of bacteria, toxins, diseases, and allergens (paragraphs [0008],[0008]) and Obremski’s teachings of detecting target analytes including hormones, illicit drugs, cancer related molecules, toxins, antibodies to viruses and diseases (column 14, lines 35-54) to provide: wherein the plurality of different analytes in the liquid sample are selected from the group consisting of: drug residues, toxins, viruses, bacteria, hormones, heavy metals, adulterants, allergens, a mixture thereof, and any combination thereof. Doing so would have a reasonable expectation of successfully improving multiplexed analysis of a sample for known desired target analytes, therefore improving versatility of the overall diagnosis kit.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rao in view of Obremski, Polito, O’Farrell as applied to claim 7 above, and further in view of Tsukada et al. (US 20110244597 A1, cited in the IDS filed 02/27/2024).
Regarding claim 8, modified Rao fails to teach: wherein the plurality of different analytes comprise drug residues and are selected from the group consisting of: penicillins, cephalosporines, tetracyclines, sulphonamides, aminoglycosides, aminocyclitols, macrolides, quinolones, ionophores, carbadox, nitrofuran antibiotics, phenicols, a mixture thereof, and any combination thereof.
Tsukada teaches an immunochromatographic medium and method to detect and quantify a plural items simultaneously (abstract), wherein the medium comprises a two- dimensional matrix of dots (Fig. 1; abstract). Tsukada teaches that the substances to be detected include pathogens, antibiotic substances such as tetracyclines, and toxins (paragraph [0050]). Tsukada teaches the invention improves diagnosis according to immunochromatography (paragraph [0104]).
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 analyte of modified Rao to incorporate the teachings of Tsukada to provide wherein the diagnosis kit is capable of simultaneously and specifically detecting the plurality of different analytes wherein the plurality of different analytes comprise drug residues and are selected from the group consisting of: penicillins, cephalosporines, tetracyclines, sulphonamides, aminoglycosides, aminocyclitols, macrolides, quinolones, ionophores, carbadox, nitrofuran antibiotics, phenicols, a mixture thereof, and any combination thereof. Doing so would improve the diagnosis capabilities of the diagnosis kit and allow for detection of known substances of importance related to diagnosis as taught by Tsukada.
Response to Arguments
Applicant’s arguments, see pages 10-11, filed 10/27/2025, with respect to claim interpretations under 35 U.S.C. 112(f) and rejections under 35 U.S.C. 112(a) and 112(b) regarding the terms “communication system”, “selection system”, and “determination system” have been fully considered and are considered persuasive due to the amended claims. The Declaration under 37 CRF 1.132 filed 10/27/2025, with respect to claim interpretations under 35 U.S.C. 112(f) and rejections under 35 U.S.C. 112(a) and 112(b) regarding the terms “communication system”, “selection system”, and “determination system” have been fully considered and are considered moot due to the cancellation of the terms “communication system”, “selection system”, and “determination system”. The claim interpretations under 35 U.S.C. 112(f) and rejections under 35 U.S.C. 112(a) and 112(b) regarding the terms communication system”, “selection system”, and “determination system” of 07/29/2025 have been withdrawn.
Applicant’s arguments, see pages 11-15, filed 10/27/2025, with respect to the rejection(s) of claims 1-8 under 35 U.S.C. 103 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 Rao et al. (US 20150087543 A1, cited in the IDS filed 02/27/2024) in view of Obremski et al. (US 6110749 A) in view of Polito et al. (US 20040018637 A1) and O’Farrell et al. (US 20120184462 A1; cited in the IDS filed 02/27/2024).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pawlak et al. (US 20090163374 A1) teaches a process for detecting one or more analytes in one or more samples (abstract), including a microarray (abstract). Pawlak teaches an array of measurement areas (Fig. 1). Pawlak teaches different analytes are detected in a shared array of measurement areas by adding distinguishable detection reagents to said array (paragraph [0084]). Pawlak teaches multiplicity of different analytes in a multiplicity of arrays of discrete measurement areas are detected by adding different binding reagents as specific binding partners for determining different analytes on various arrays of discrete measurement areas and/or by adding distinguishable detection reagents to said arrays of measurement areas (paragraph [0085]). Pawlak teaches the solid support can include nitrocellulose membranes (paragraph [0124]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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, Maris Kessel can be reached at (571) 270-7698. 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.
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758