DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application was filed on 05/02/2024. This application claims benefit of the foreign Application CHINA 2023107105018 filed 06/14/2023.
Claim status
Claims 1-10 are pending and examined.
Drawings
The drawings are objected to because figures 7, 8, and 9 are not clear to show the differences among the results.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 2 is 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 2 recites “gold nanoparticles” and “colloidal gold labeled”. It is not clear if the “gold nanoparticles” are the same as “colloidal gold labeled”. The “colloidal gold particles” are mentioned in paragraphs 37 and 65, and the “gold nanoparticles” are mentioned in paragraphs 9 and 36. Nowhere in the specification discloses that the gold nanoparticles are used for the colloidal gold label. The specification discloses that the colloidal gold particles are used to prepare the colloidal gold-labeled enramycin monoclonal antibody (see par.37). Since particles are different from nanoparticles, it is not clear the role of gold nanoparticles in the test strip.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian et al. (CN104880552) in view of Chen (CN109295004).
For claim 1: claim 1 recites “A colloidal gold immunochromatographic test strip for detecting enramycin, the test strip comprises a backing plate, a sample pad, a conjugate pad, a nitrocellulose membrane and an absorbent pad, the conjugate pad is fixed with colloidal gold labeled enramycin monoclonal antibodies; the nitrocellulose membrane is equipped with a T-line coated with enramycin artificial antigens and a C-line coated with goat anti-mouse secondary antibodies.”
Jian teaches a colloidal gold immunochromatographic test strip for detecting an antigen (e.g., enrofloxacin) and preparation method thereof (see page 1 line 11). The test strip comprises a sample pad, a bonding pad, a nitrocellulose coating film, an absorbent pad and a PVC bottom plate (i.e., a backing plate). The bonding pad is a conjugate pad because it is coated with an enrofloxacin monoclonal antibody-colloidal gold label. The nitrocellulose coating film is provided with a detection A line coated with an enrofloxacin drug antigen and a quality control line coated with a goat anti-mouse IgG. See page 2 lines 29-35, page 4 lines 15-23.
Jian does not teach the test strip is for detecting enramycin. Jian does not clearly state that the enrofloxacin drug antigen is an artificial antigen.
Chen teaches an anti-enramycin monoclonal antibody and an immunodetection application of the antibody (see page 1 lines 15-17). The application is an immunological detection tool, e.g., a test strip to detect whether the sample contains an enramycin residue (see page 2 lines 25-30). Chen discloses that high purity Enramycin A component coupled with a carrier protein (BSA or OVA) as a coating agent (Er-A-BSA or Er-A-OVA) is used to fix the antigen on a solid phase in a detection method (see page 3 lines 40-58). The Er-A-BSA or Er-A-OVA is an artificial antigen as disclosed by the instant specification paragraph 10 and the instant claim 3.
Chen teaches that long-term consumption of foods containing antibiotic residues can cause MDR pathogens from entering the body, thereby reducing the efficacy of antibiotics against bacterial infections, leading to more deaths (see page 1 and 2 Background technique). There is an urgent need to develop an immunological rapid detection method based on a highly sensitive anti-enramycin A monoclonal antibody to detect various antibiotic residues in foods (see page 1 and 2 Background technique). The rapid screening method is a colloidal gold detection method because of its rapid detection, high sensitivity, and high flux. It has been widely used for rapid detection of various antibiotic residues in foods (see page 1 lines 57-59, page 2 line 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test strip of Jian, replacing the enrofloxacin antigen and the enrofloxacin monoclonal antibody-colloidal gold label by enramycin antigen and the enramycin monoclonal antibody-colloidal gold label for achieving a colloidal gold immunochromatographic test strip for detecting enramycin. One of ordinary skill in the art would have been motivated to do that, because the colloidal gold immunochromatographic test strip can quickly detect enramycin residues in foods, thereby reducing MDR pathogens from entering the body (see Chen page 1 and 2 Background technique).
One of ordinary skill in the art would have had a reasonable expectation of success in combining Jian and Chen because Jian discloses a base device, e.g., the structure of the test strip and the pre-treatment of the conjugate pad and the nitrocellulose membrane; whereas Chen discloses known components that are applicable to the base device, e.g., the enramycin and the anti-enramycin monoclonal antibody which are used in an immunoassay to detect if the sample contains an enramycin residue (see Chen page 2 lines 25-30). It is obvious to one of ordinary skill in the art to select the antigen/antibody according to the actual test, and the replacement would yield a predictable result, e.g., detecting enramycin in a sample, because the anti-enramycin monoclonal antibody and the enramycin taught by Chen can be used in an immunoassay to detect enramycin.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian in view of Chen, as applied to claim 1 above, and further in view of Markovsky et al. (US20030207442) and Boekel et al. (US20110008910).
For claim 2, Jian and Chen teach the colloidal gold immunochromatographic test strip as in claim 1. Jian teaches the process of defining the optimal protein labeling amount for colloidal gold-labeled antibodies, which is based on the sensitivity of analyte detection of the test strip (see page 3 lines 45-50, page 5 lines 15-60). Jian does not teach the diameter of gold nanoparticles and the coating concentration of colloidal gold-labeled enramycin monoclonal antibodies as recited in claim 2.
Markovsky teaches a test strip for detecting the presence of a residue analyte in a sample, e.g., antibiotics (see Abstract, par.21). The test strip comprises a support strip 30, a sample pad 32, a conjugate pad 33, a nitrocellulose membrane 36 and an absorbent pad 43 (see at least par.40-41, 49, 60, 69 and 70, see Fig.1). Markovsky also teaches that a labeled receptor is used to detect the analyte, wherein the labeled receptor is a colloidal gold-labeled antibody (see par.7 and 148-149). The diameter of the gold particles is between 10 and 60 nm (see par.57 and 148). Markovsky teaches that a pre-calibrated amount of purified antibodies are coated on colloidal gold beads. Then, antibody coated gold beads are sprayed in the conjugate pad (see par.148-149).
Boekel teaches that colloidal gold particles or gold nanoclusters having a diameter of 25-40 nm are probably the most commonly applied labels in lateral flow immunoassays (see par.7). Boekel teaches that there is a limited amount of antibodies coated on the test strip (see par.18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test strip of Jian in view of Chen, using the colloidal gold particles having a diameter of 40-60 nm in the test strip with a reasonable expectation of success because Markovsky and Boekel teach that colloidal gold particles having a diameter of 10-60 nm are commonly applied labels in lateral flow immunoassays.
While Jian, Chen and Boekel do not teach the same amount of colloidal gold labeled enramycin monoclonal antibodies on the test strip, Markovsky and Boekel are generic about the amount of labeled antibody on the test strip and Jian teaches that a coating concentration of labeled antibodies can be optimized according to practical needs, e.g., improving the sensitivity of the test.
At the time of invention, it would have been obvious to one of ordinary skill in the art to discover the workable concentration of the labeled antibody by an optimization procedure known in the art (e.g., taught by Jian on page 5 lines 15-60) to achieve a desired sensitive lateral flow immunochromatography (LFIA) based on colloidal particles.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian in view of Chen, as applied to claim 1 above, and further in view of Markovsky et al. (US20030207442).
For claim 3, Jian and Chen teach the colloidal gold immunochromatographic test strip as in claim 1. Jian teaches that the antigen coating concentration was 0.05 mg/mL (see Jian page 3 line 8). Jian in view of Chen discloses high purity Enramycin A component coupled with a carrier protein (BSA or OVA) as a coating agent (Er-A-BSA or Er-A-OVA) is used to fix the antigen on a solid phase in a detection method (see page 3 lines 40-58). The coating antigen is obtained by coupling Enramycin A and a carrier protein by N,N'-carbonyldiimidazole (see Chen page 3 lines 40-41).
Jian does not teach the same coating concentration of the artificial antigens as recited in claim 3.
Markovsky teaches a test strip for detecting the presence of a residue analyte in a sample, e.g., antibiotics (see Abstract, par.21). The test strip comprises a support strip 30, a sample pad 32, a conjugate pad 33, a nitrocellulose membrane 36 and an absorbent pad 43 (see at least par.40-41, 49, 60, 69 and 70, see Fig.1). Markovsky also teaches that BSA or OVA is attached to antigens to form antigen conjugates which are then sprayed on the test line of the nitrocellulose strip (see par.154). The concentration of the antigen conjugates is varied, e.g., 0.6 to 1.0 μl/cm of 5 mg/ml antigen conjugates (see par.107) or 1-1.5 μl/cm of 5-20 mg/ml antigen conjugates (see par.121) or 2-20 ng total antigen per cm (see par.154).
Jian and Markovsky teach a varied amount of antigen conjugates used in the test strip. At the time of invention, it would have been obvious to one of ordinary skill in the art to define the workable concentration of the antigen conjugates by an optimization procedure known in the art according to practical needs, e.g., improving the sensitivity of analyte detection.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian in view of Chen, as applied to claim 1 above, and further in view of Koczula et al. (Lateral flow assays Essays in Biochemistry (2016) 60 111–120) and Merck (Rapid Lateral Flow Test Strips 2013).
For claim 4, Jian and Chen teach the colloidal gold immunochromatographic test strip as in claim 1. Jian further teaches a preparation method for the colloidal gold immunochromatographic test strip comprising overlapping the sample pad, the conjugate pad, the nitrocellulose membrane, and the absorbent pad in turn on the backing plate, and the T -line is located on a side near the conjugate pad (see page 4 lines 15-24 and 47-60, fig.1 in original document: showing that a detection line 31 is near the bonding pad 2).
Jian further teaches soaking and drying the sample pad in a solution containing BSA, sucrose (see page 5 lines 1-6). Jian does not teach a solution containing S9 and the same concentration of each substance in the pre-treatment solution as recited in the claim 0.5-1.5 % BSA, 1.5-2.5 % sucrose, and 1.5-2.5 % S9.
Fig.1 of Jian
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Koczula teaches that a sample pad is for evenly distributing the sample and to direct it to the conjugate pad in a lateral flow strip. The sample pad is usually impregnated with buffer salts, proteins (e.g., BSA), surfactants (e.g., S9) and other liquids to control the flow rate of the sample and to make it suitable for the interaction with the detection system. See page 114 Sample pad section.
Merck teaches that a sample pad is pretreated with a variety of chemical agents designed to make the full range of samples compatible with the functioning of the test strip. Fundamentally, enough chemistry must be loaded to make all samples behave similarly in the test. Unlike chemical considerations for the capture reagents and detector particles, there are far fewer constraints on what can be added to the sample pad. See page 27 Sample pad section.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the sample pad pre-treating solution as taught by Jian, by selecting the chemical agents with suitable concentrations for making a sample pad treating solution by an optimization procedure known in the art to control the flow rate of the sample and to make it suitable for the interaction with the detection system as taught by Koczula and Merck. One of ordinary skill in the art would have had a reasonable expectation of success in modifying the sample pad pre-treating solution, because there is less constraint on what can be added to the sample pad as long as it can make all samples behave similarly in the test (see Merck page 27 Sample pad section).
Claim(s) 5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian in view of Chen, as applied to claim 1 above, and further in view of Huet et al. (Simultaneous Determination of (Fluoro)quinolone Antibiotics in Kidney, Marine Products, Eggs, and Muscle by Enzyme-Linked Immunosorbent Assay (ELISA), J. Agric. Food Chem. (2006) 54 (8): 2822–2827), Wang et al. (Enzyme-linked immunosorbent assay and colloidal gold immunoassay for ochratoxin A: investigation of analytical conditions and sample matrix on assay performance, Anal Bioanal Chem (2007) 389:903–911), and Merck (Rapid Lateral Flow Test Strips 2013).
For claim 5, Jian and Chen teach the colloidal gold immunochromatographic test strip as in claim 1. Jian teaches that the sample treatment solution comprises phosphate buffer containing methanol (see page 7 lines 51-60 and page 8 lines 1-7: disclosing that 0.01 M phosphate buffer with 5% methanol is used in sample extraction process).
Jian does not teach that the sample solution comprises PBS. Jian does not teach the same concentration of methanol in the sample solution.
Jian does not teach a kit for detecting enramycin. Jian does not teach diluting the sample extract before testing. Jian does not teach a sample diluent comprising a 0.01 M PBS solution containing 1 % Tween 20 and 1 % S9 for sample diluent.
Chen teaches that the enramycin and the anti-enramycin monoclonal antibody are used in an immunodetection application, e.g., a kit to detect if the sample contains an enramycin residue (see Chen page 2 lines 25-30). Chen also teaches a solution for treating a sample comprising PBS and 50% methanol (see page 6 lines 25-30: teaching the standard solution of enramycin was prepared with PBS, page 6 lines 45-50: teaching that pork sample was mixed with enramycin standard and 50% methanol before being extracted, the teaching implies that the sample treatment solution contains PBS from enramycin standard solution and 50% methanol). Chen teaches that the enramycin extract is diluted before testing (see page 7 lines 1-2).
Huet teaches a common extracting solution for a variety of antibiotic residues from food samples, e.g., a 1:1 mixture of methanol and phosphate-buffered saline adjusted to pH 7.4, which means 0.01M PBS solution containing 50% methanol (see Abstract). The sample extract is then diluted with an assay buffer comprising PBS, 0.05% Tween-20 (see page 2823 col.1 Generic ELISA Procedure). The antibiotic residues from food samples are detected using ELISA but not by the lateral flow strip.
Wang teaches a colloidal gold immunoassay test strip to detect an analyte extracted from food (see page 910 Colloidal gold immunoassay). Wang uses 5% methanol prepared in PBST, pH 9.0 as an extracting solution. After extraction, food sample extracts were applied to the colloidal gold immunoassay without dilution. The colloidal gold immunoassay test strip shows lower background color in unspotted areas and strong color development with the same amount of coated OTA–OVA conjugate and gold–antibody compound. This result indicates that matrix interference was not significant (see page 910 Colloidal gold immunoassay, see Fig.3).
Merck teaches that the application of liquid reagents (i.e., sample) may remove surfactants and detergents from the membrane, or lower their concentrations, and change overall wetting characteristics. Thus, adding a low concentration of surfactant or detergent into all or some of the applied solutions can avoid this change. See page 11 Maintaining Wettability by Adding Detergents and Surfactants to Solutions Used during Reagent Application and Blocking.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a kit for detecting enramycin by using the colloidal gold immunochromatographic test strip taught by Jian and Chen for the benefit of fast testing because the kit supplies a ready to use components for the test. One of ordinary skill in the art would have had a reasonable expectation of success in doing this because Chen teaches that the enramycin and the anti-enramycin monoclonal antibody are used in an immunodetection application, e.g., a kit to detect if the sample contains an enramycin residue (see Chen page 2 lines 25-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the extraction buffer of Jian, using the extraction buffer taught by Chen, because Chen specifically teaches the extraction buffer for extracting enramycin. Accordingly, the kit comprises an extraction buffer with 0.01M PBS solution containing 50% methanol as taught by Chen. When using 50% methanol solution for extraction, the sample needs to be diluted before testing on the colloidal gold test strip as taught by Chen and Huet (see Chen page 7 lines 1-2; see Huet page 2823 col.1 Generic ELISA Procedure). Therefore, the kit also comprises a sample diluent buffer with PBS and Tween-20 to dilute the sample before testing as taught by Chen and Huet above. One of ordinary skill in the art would have been motivated to dilute the enramycin extract before testing to prevent the matrix interference on the strip as the colloidal gold immunoassay test strip of Wang shows lower background color in unspotted areas and strong color development with the same amount of coated OTA–OVA conjugate and gold–antibody compound when Wang tests the sample in 5% methanol solution (see Wang page 910 Colloidal gold immunoassay, see Fig.3).
The diluent buffer can further have a low concentration of surfactant, e.g., S9 to avoid the changing of wetting characteristics of the test strip as taught by Merck. It would have been obvious to one of ordinary skill in the art to modify the components and the concentration of the components in the diluent buffer by an optimization procedure known in the art to prevent the change of wetting characteristics for successful analyte detection as taught by Merck.
One of ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because Chen and Huet are drawn to antibiotic residue extraction from food samples, which is a required step before detecting antibiotic residues with an immunoassay, e.g., the test strip of Jian. Wang teaches the optimal concentration of methanol in the sample solution before testing to achieve the best color development on the test strip. Merck provides information on the key aspects of immunochromatographic test strip design which are helpful for developing the test kit (see Merck page 1 col.2 par.3).
For claim 7, Jian, Chen, Huet, Wang and Merck teach the kit as in claim 5. Jian teaches the method of detecting an analyte comprising: adding the sample treatment solution to a sample to be tested, after oscillation, ultrasonication, and centrifugation, filtering an obtained supernatant to obtain a sample extract (see page 7 lines 50-60 and page 8 lines 1-11); detecting the sample solution by a colloidal gold immunochromatographic test strip (see page 8 lines 9-11).
Jian uses 5% methanol solution for the extraction step (see page 7 lines 51-60 and page 8 lines 1-7). Jian does not teach diluting the sample before testing.
Chen uses 50% methanol solution for the extraction step and teaches that the enramycin extract is diluted before testing (see page 6 lines 25-30 and 45-50, and page 7 lines 1-2).
Huet uses 50% methanol solution for the extraction step and teaches that the antibiotic extract is diluted with an assay buffer comprising PBS, 0.05% Tween-20 before testing (see page 2823 col.1 Generic ELISA Procedure).
Wang uses 5% methanol solution for the extraction step and the sample extract is applied directly on the colloidal gold test strip (see page 910 Colloidal gold immunoassay).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Jian for detecting enramycin by diluting the sample extract before testing as taught by Chen and Huet, because Chen specifically teaches the extraction buffer for extracting enramycin comprising 50% methanol, and states that the sample extract needs to be diluted before testing (see Chen page 7 lines 1-2). One of ordinary skill in the art would have been motivated to dilute the sample extract before testing with a reasonable expectation of success, because Jian and Wang support that a low percentage of methanol in a sample solution (e.g., 5% methanol solution) works well on the colloidal gold test strip because it prevents matrix interference on the strip (see Wang page 910 Colloidal gold immunoassay).
For claim 8, Jian, Chen, Huet, Wang and Merck teach the method according to claim 7. Jian and Chen also teach that the sample to be tested comprises animal feed and products of animal meat and egg (see Jian page 1 line 26, page 7 lines 50-60; see Chen page 2 lines 32-35: disclosing that animal meat is pork, chicken, and beef).
For claim 9, Jian, Chen, Huet, Wang and Merck teach the method according to claim 7. Jian teaches a detection result of the colloidal gold immunochromatographic test strip is qualitatively judged by naked eyes (see page 6 Example 4, page 7 line 1 disclosing “the coloration of the test line (T line) and quality control line (C line) of the test strip is observed”).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian in view of Chen, Huet and Merck, as applied to claim 5 above, and further in view of Marcelpoil et al. (US20220128455) and Lunadei et al. (Image-Based Screening for the Identification of Bright Greenish Yellow Fluorescence on Pistachio Nuts and Cashews, Food Bioprocess Technol (2013) 6:1261–1268).
For claim 6, Jian, Chen, Huet, Wang and Merck teach the kit as in claim 5. They do not teach a test strip shooting background board.
Marcelpoil teaches a background device for reading lateral flow assay results (see par.2-3). The device comprises a white positioning frame where a test cartridge can be positioned prior to taking an image and a test card frame in the test cartridge (see par.28, Fig.1A, 2 or 4). Marcelpoil states that to limit the occurrence of errors in image-based test analysis systems, imaging systems for test analysis are usually operated in very controlled environments and carefully calibrated and normalized. When a calibrated and controlled environment is not available, image qualification and normalization metrics may need to be extracted from the image itself. See paragraph 4.
Accordingly, the device of Marcelpoil comprises one or more pieces of information to limit the occurrence of errors in image-based test analysis systems, which includes intensity or color that allows a refined image capture, leading to image acquisition conditions validation, image normalization, and/or image standardization prior to analysis using evaluation software or manual interpretation. See paragraph 4. For example, the background portion includes color-balanced areas (small R,G,B squares 120 in Fig.1A) which simplifies the evaluation and correction of the white balance of the scene, regardless of the spectral characteristics of the incoming light (see par.7, 38, and Fig.1A). The presence and concentration of a plurality of analytes in a sample is determined by using the 3D background device and a software application configured to analyze an image of the lateral flow assay test strip (see par.8).
Lunadei teaches a vision system that is able to detect a target analyte via image-based analysis (see Title, page 1263 col.1 par.2 and col.2 par.1). The system comprises a shooting background chamber with black walls that was put around the vision test station in order to create a uniform light field around the object. The images were acquired using a black background. In order to adjust the color balance of the images (calibration image), all the images were subjected to a white balancing using a standard white card (whose intensity values in the RGB space color was 255–255–255). See page 1263 column 2 paragraph 1. The presence of an analyte in a sample can be automatically and rapidly detected by the vision system and an image algorithm (see page 1263 col.1 par.2, page 1266 Table 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Jian, using a test strip shooting background device consisting of a pure black background, a white positioning frame, a standard black color block, a standard white color block, and a test card frame for analyzing the test result. One of ordinary skill in the art would have been motivated to use the test strip shooting device because Marcelpoil and Lunadei teach the device helps to analyze the results automatically and rapidly. Moreover, the black background helps to create a uniform light field around the test strip as taught by Lunadei. The white and black blocks on the background help to adjust the color balance of the images when a controlled environment is not available so that it can limit the occurrence of errors in the image-based analysis system (see the teachings of Marcelpoil and Lunadei above).
One of ordinary skill in the art would have had a reasonable expectation of success in combining Marcelpoil and Lunadei references because the background devices are both used for an accurate and automatic analyte screening method based on an image-based analysis or a vision system (see Marcelpoil Abstract and Lunadei Abstract).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jian in view of Chen, Huet, Wang, Merck, as applied to claim 9 above, and further in view of Marcelpoil et al. (US 20220128455), Lunadei et al. (Image-Based Screening for the Identification of Bright Greenish Yellow Fluorescence on Pistachio Nuts and Cashews, Food Bioprocess Technol (2013) 6:1261–1268), Zhang et al. (A smartphone-based rapid quantitative detection platform for lateral flow strip of human chorionic gonadotropin with optimized image algorithm, Microchemical Journal 157 (2020) 105038) and Supporting information, and Yin (CN113537203).
For claim 10, Jian, Chen, Huet, Wang and Merck teach the method according to claim 9. Jian does not teach a quantitative reading method.
See the teachings of Marcelpoil and Lunadei in claim 6 above for the background device comprising black and white color blocks to adjust the color balance of the images. Marcelpoil and Lunadei teach that a software application is used to analyze an image of the lateral flow assay test strip (see Marcelpoil par.8, Lunadei Abstract).
Lunadei further teaches identifying actual gray values of standard black color block, standard white color block (see page 1264 col.2 par.1: disclosing that the gray level of standard black is 0, the gray level of standard white is 1), T-line, and C-line (see page 1264 col.1 par.2: disclosing that the gray level of region of interests are different than 0) to detect the concentration of the analyte on the sample.
Zhang teaches a rapid quantitative detection platform for colloidal gold lateral flow strips using an image processing method, the grayscale projection value processing algorithm (see Abstract). Because C and T lines of the test strip had a large difference in grayscale intensity with the background area, C and T lines could also be located and distinguished from the background area by grayscale projection. A series of theoretical gray values from a pre-defined concentration of an analyte is obtained by using image analyzing software. From that projection curve, the concentration of the analyte is calculated based on the actual gray values of T-line and C-line on the test strip. See section 3.2.3 Gray projection value processing based on the test strip and Figure S7. This teaching encompasses the limitation in claim 10.
Yin provides a test strip identification method combining deep learning and regular image processing (see page 1 lines 47-51). Yin uses OpenCV algorithm to read the test strip result, wherein the reading is based on the grayscale image (see page 2 par.2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the OpenCV algorithm to analyze the results of the test strip in the method of claim 9 with a reasonable expectation of success, because Yin teaches OpenCV algorithm can analyze the results of the colloidal gold lateral flow strip based on the grayscale image. By using the gray projection value method, the quantitative information is obtained by comparing the actual gray values of T-line and C-line on the test strip with the projected gray value on the standard projection curve to obtain the corresponding concentration as taught by Zhang.
One of ordinary skill in the art would have been motivated to use OpenCV algorithm because it is free and open source across multiple languages. Moreover, using a quantitative reading method helps to analyze the results automatically and rapidly.
One of ordinary skill in the art would have had a reasonable expectation of success in combining those prior art references because the background devices of Marcelpoil and Lunadei are both used for an accurate and automatic analyte screening method based on an image-based analysis or a vision system (see Marcelpoil Abstract and Lunadei Abstract), Zhang supports the use of image analyzing software in quantifying the concentration of the analyte according to the gray values of t-line and c-line on a colloidal gold lateral flow strip (see Zhang section 3.2.3 Gray projection value processing based on test strip and Figure S7) while Yin teaches that OpenCV can read the test strip result, wherein the reading is based on the grayscale image (see Yin page 2 par.2).
Conclusion
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/CHAU N.B. TRAN/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 September 5, 2026
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