DETAILED ACTION
Claims 1-17 are pending.
Election/Restrictions
Applicant's election with traverse of group I claims 1-11 in the reply filed on 01/12/2026 is acknowledged. The traversal is on the ground(s) that examining groups I, II, and III simultaneously would not impose an undue burden on the examiner. This is not found persuasive. Applicant's attention is directed to MPEP § 808.02, which states: “Where the inventions as claimed are shown to be independent or distinct under the criteria of MPEP § 806.05(c) - § 806.06, the examiner, in order to establish reasons for insisting upon restriction, must explain why there would be a serious search and/or examination burden on the examiner if restriction is not required. In order to demonstrate a serious search burden, the examiner must show by appropriate explanation one of the following:
• (A) Separate classification thereof: This shows that each invention has attained recognition in
the art as a separate subject for inventive effort, and also a separate field of search. Patents need not be cited to show separate classification.
• (B) A separate status in the art when they are classifiable together: Even though they are
classified together, each invention can be shown to have formed a separate subject for inventive effort when the examiner can show a recognition of separate inventive effort by inventors. Separate status in the art may be shown by citing patents which are evidence of such separate status, and also of a separate field of search.
• (C) A different field of search: Where it is necessary to search for one of the inventions in a
manner that is not likely to result in finding art pertinent to the other invention(s) (e.g., searching
different classes/subclasses or electronic resources, or employing different search queries), a
different field of search is shown, even though the two are classified together. The indicated
different field of search must in fact be pertinent to the type of subject matter covered by the
claims. Patents need not be cited to show different fields of search."
As set forth in the restriction requirement of 11/14/2025, Group I is classified in G01N 33/56983, Group II is classified in G06T 2207/30004, and Group III is classified in H04N 1/00193. The separate classification established for each Group demonstrates that each distinct Group has attained recognition in the art as a separate subject for inventive effort, and also a separate field of search. As stated in the restriction requirement on 11/14/2025, Group I can not solely be used with the device of Group II or Group III. Further, the invention of Group III can be used with entirely different media, such as information from an automated ELISA immunoassay, for example.
The requirement is still deemed proper and is therefore made FINAL.
Newly added claim 17 is directed towards the non-elected invention.
Claims 12-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/12/2026.
Claims 1-11 are under examination.
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.
1.Claims 1-11 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.
Claims 1 and 11 recite “lateral flow type kit”. Claim 9 recites “different kinds of lateral flow test kits”. The specification does not provide any examples or further clarify what is meant by “lateral flow type kit” or “different kinds of lateral flow test kits”. It is unclear what applicant is referring to with “type” and “kinds” of lateral flow kits. It is also unclear if “type” and “kinds” are referring to the same thing. It is unclear if applicant is referring to the type of biomarker that the lateral flow test is used for or the construct of the lateral flow assay (e.g., materials or designs).
2.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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “any chemical substance” and the claim also recites “which may include drugs, metabolites, proteins, and the like” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 2, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
3.Claim 4 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.
The terms “very low, low, medium, high, and very high” in claim 4 are relative terms which renders the claim indefinite. The terms “very low, low, medium, high, and very high” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear the value or threshold that would qualify the label being “very low, low, medium, high, and very high”.
4.Claims 6-7 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.
The term “median range” in claim 6 is a relative term which renders the claim indefinite. The term “median range” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 6 refers to the “median value” of the segment corresponding to the range of color intensity index values. However, it is unclear what value or threshold would qualify the value being the “median”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5.Claims 1-2 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park, Jongwon. “An Optimized Colorimetric Readout Method for Lateral Flow Immunoassays.” Sensors (Basel, Switzerland) vol. 18,12 4084. 22 Nov. 2018, doi:10.3390/s18124084.
Regarding claim 1, Park teaches a method for quantitatively analyzing a test result of a lateral flow-type test kit, wherein the test kit comprises a result area with a quality control C-line region and a detection T- line region (see figure 3 on page 4 showing the test line and control line of a lateral flow immunoassay strip), the method comprising:
determining an analyte concentration range that the test kit can detect (see abstract “The change in the intensity ratio with increasing concentration of the target substance in the sample was largest in the green channel.”);
diluting a sample into a plurality of sample dilutions having different pre-determined analyte concentrations within the determined analyte concentration range (see page 4 “Because blood samples were not available for this study, CK-MB (1-028, BioSpecifics, Lynbrook, NY, USA) was diluted with serum (22000, SeraCare Life Sciences, Milford, MA, USA) to obtain 0, 2, 4, 10, 50, and 100 ng/mL solutions that were used as samples.”);
applying each sample dilution having a pre-determined analyte concentration to a sampling well on the rapid test kit for the analyte, so as to obtain separate resulting images with different color intensities on the T-line region corresponding to different pre-determined analyte concentrations (see page 4 teaching the sample being added to the strip, reacting with a mouse IgG gold label coated with a monoclonal antibody at the conjugate release pad of the assay, then the mixture of the sample and antibody flows through the porous membrane by capillary action to react with capture reagent and generate a colored line);
calculating a corresponding color intensity index values for the T-line regions of each resulting image, respectively (see page 3 “From the experiment in Figure 1, we selected the color band (i.e., red, green, or blue) in which the pixel intensity of the test line varied the most with respect to the change in the target material concentration in the assay. This selected color channel was used to quantify the assay. Let I(t) and I(b) be the average pixel intensity values of the region of interest in the test line portion and the background portion of the assay membrane, respectively. I(b)/I(t) was calculated for the test line that formed when the sample solution was developed on the assay”); and
creating a continuous curve by fitting the corresponding plurality of color intensity index values to the plurality of different pre-determined analyte concentrations, wherein the corresponding analyte concentration can be obtained based on the color intensity index value at any point on the continuous curve (see figure 6 on page 7 “Pixel intensity response curves using the total color (i.e., original color), red, green, and blue images of the LFIA (a) and the enlarged response curves for the creatine kinase–muscle/brain (CKMB) concentration range of 0 to 10 ng/mL (b). An average of 10 measurements is shown, and the error bars show the standard deviation. The dashed line in (b) shows the linear regression result of the green channel”, see page 4 “These concentrations reflect the criteria for clinical positive and negative determinations, where the concentration of CK-MB in the blood deemed negative for myocardial infarction is less than 1.9–8.7 ng/mL [13,14].”).
Regarding claim 2, Park teaches the analyte being a chemical substance, such as a protein (see page 4 teaching the analyte being CK-MB, which is a known protein).
Regarding claim 9, Park teaches that the lateral flow tests can be used with various target substances (see page 1, see page 3, see page 6).
6.Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. “Rapid field determination of SARS-CoV-2 by a colorimetric and fluorescent dual-functional lateral flow immunoassay biosensor.” Sensors and actuators. B, Chemical vol. 351 (2022): 130897. doi:10.1016/j.snb.2021.130897.
Regarding claim 1, Han teaches a method for quantitatively analyzing a test result of a lateral flow-type test kit, wherein the test kit comprises a result area with a quality control C-line region and a detection T- line region (see scheme 1 on page 3 showing a lateral flow test strip with a control line and a test line), the method comprising:
determining an analyte concentration range that the test kit can detect (see page 5 “This assay was designed with the following key parameters as the starting points: type of NC membrane, reaction time, antibody concentration on the test line.”, see figure 3 showing the concentrations of an analyte);
diluting a sample into a plurality of sample dilutions having different pre-determined analyte concentrations within the determined analyte concentration range (see page 5 “All optimized conditions were applied to detect SARS-CoV-2 S1 protein and evaluate the sensitivity of SiO2@Au/QDs-based LFIA biosensor. The SARS-CoV-2 S1 protein was serially diluted from 1000 ng/mL to 0.05 ng/mL for eight concentrations and then loaded onto the strip biosensor. The control lines of all LFIA strips showed purple and fluorescent bands (Fig. 3b), indicating that the strip biosensor was working properly.”);
applying each sample dilution having a pre-determined analyte concentration to a sampling well on the rapid test kit for the analyte, so as to obtain separate resulting images with different color intensities on the T-line region corresponding to different pre-determined analyte concentrations (see page 5 “All optimized conditions were applied to detect SARS-CoV-2 S1 protein and evaluate the sensitivity of SiO2@Au/QDs-based LFIA biosensor. The SARS-CoV-2 S1 protein was serially diluted from 1000 ng/mL to 0.05 ng/mL for eight concentrations and then loaded onto the strip biosensor. The control lines of all LFIA strips showed purple and fluorescent bands (Fig. 3b), indicating that the strip biosensor was working properly”);
calculating a corresponding color intensity index values for the T-line regions of each resulting image, respectively (see figure 3, see figure 5); and
creating a continuous curve by fitting the corresponding plurality of color intensity index values to the plurality of different pre-determined analyte concentrations, wherein the corresponding analyte concentration can be obtained based on the color intensity index value at any point on the continuous curve (see figure 2).
Regarding claims 2-3, Han teaches the analyte being a chemical substance and the sample being an inactivated virus (see page 6 “We detected inactivated viruses of SARS-CoV-2 to further verify the practical analytical capability of the new biosensor. SARS-CoV-2 inactivated virus were continuously diluted from 1.41 × 107 copies/mL to 7.06 × 103 copies/mL in 8 concentrations, and then virus diluents were dropped on the sample pads.”, see table 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
7.Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Han et al., as applied to claims 1-3 above.
Regarding claim 4, Han teaches each segment having a range of color intensity index values corresponding to "medium" and "high” sample concentration ranges (see figure 4a showing medium concentration samples and high concentration samples). While Han does not explicitly state that labeling concentrations from "very low", "low", and " very high", it would have been obvious to one of ordinary skill in the art to label the concentrations accordingly, especially as Han teaches labeling the medium concentrations and high concentrations.
One of ordinary skill in the art would have been motivated to use the methods of Han because Han teaches the detection limits for colorimetric is favorable (see page 8) and the colorimetric function allows for on-site diagnosis without instruments for critically ill patients (see page 8).
8.Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al., as applied to claims 1-3 above, and in view of Shen et al. “Point-of-care colorimetric detection with a smartphone.” Lab on a chip vol. 12,21 (2012): 4240-3. doi:10.1039/c2lc40741h.
Regarding claims 5-7, Han teaches having a range of color intensity index values corresponding to "medium" and "high” sample concentration ranges (see figure 4a). Han does not explicitly state the median value, the color-patch, or printing the color-block on paper or displaying the color-block on a display.
The instant application teaches that the median value color-patch is a paper printed with the corresponding words "very low", "low", "medium", "high", " very high" (see [0028] of the instant specification).
Shen teaches making a color-patch that corresponds with the color on the strip (see figure 1). Shen teaches printing the color-block on paper and displaying the color-block on display (see figure 1).
While Shen and Han don’t teach the corresponding words “very low”, “low”, or “very high” on the color-patch, it would have been obvious to one of ordinary skill in the art to optimize the color-patch with the corresponding concentration labels. Han teaches labeling the concentrations of “medium” and “high”, while Shen teaches printing out and/or displaying a color-patch as a reference chart in order to determine the results of the test strip (see page 4241 of Shen). Shen provides motivation by teaching that using colorimetric to quantify colors is versatile and works well (see page 4241).
Regarding claim 8, Han teaches obtaining an image of the T-line region with the test result by an image acquisition device (see figures 5a and 5d); analyzing the image of the T-line region to determine the color intensity index value of the T-line region (see figures 5a and 5d), and obtaining the corresponding analyte concentration according to the continuous curve (see figure 4a). Han does not teach storing the continuous curve associated with analyte concentration in a memory of a computer device.
Shen teaches storing the continuous curve associated with analyte concentration in a memory of a computer device (see page 4243 “Further, as already mentioned, with a tablet or smartphone one could take advantage of cellular network transmission and cloud-based data storage, or perform analysis outside laboratory.”).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the methods of using colorimetric and fluorescent dual-function lateral flow immunoassay biosensors taught by Han with the methods of colorimetric detection with a smartphone taught by Shen. Shen provides motivation by teaching that with a tablet or smartphone one could take advantage of cellular network transmission and cloud-based data storage, or perform analysis outside laboratory (see page 4243). Shen teaches that promising colorimetric detection results have been demonstrated using video cameras, digital color analyzers, scanner, and/or custom portable readers (see page 4240). The artisan would have reasonable expectation of success based on the cumulative disclosure of these prior art references at the time the instant application was filed.
9.Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claims 1-2 and 9, and in view of Shen et al. “Point-of-care colorimetric detection with a smartphone.” Lab on a chip vol. 12,21 (2012): 4240-3. doi:10.1039/c2lc40741h.
Regarding claim 10, Park teaches corresponding the T-line area and color intensity (see figure 3, see page 5 “As shown in the figure, the color that formed when the labeled particles collected on the test line showed the greatest intensity change at a wavelength of 546 nm, which is around the center wavelength of the green channel in the Bayer filter used in the camera module of the reader (i.e.,537)”). Park does not teach creating a type-specific continuous curve by fitting the corresponding plurality of color intensity index values to the plurality of different pre-determined concentrations and determining, in a coordinate system with the analyte concentration as the abscissa and the color intensity as the ordinate, a starting point and an end point of the fitted continuous curve within the determined color intensity range, whereby the corresponding analyte concentration for the corresponding type of kit can be obtained based on the color intensity index value at any point on the continuous curve.
Shen teaches creating a type-specific continuous curve by fitting the corresponding plurality of color intensity index values to the plurality of different pre-determined concentrations (see figure 1 showing the reference chart of the colorimetric measurements, see figure 2 showing the colorimetric measurement intensities).
Regarding claim 11, Shen teaches determining, in a coordinate system with the analyte concentration as the abscissa and the color intensity as the ordinate, a starting point and an end point of the fitted continuous curve within the determined color intensity range, whereby the corresponding analyte concentration for the corresponding type of kit can be obtained based on the color intensity index value at any point on the continuous curve (see figure 3).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the method of optimizing colorimetric readout for lateral flow immunoassays taught by Park with the methods of colorimetric detection with a smartphone taught by Shen. Shen provides motivation by teaching that with a tablet or smartphone one could take advantage of cellular network transmission and cloud-based data storage, or perform analysis outside laboratory (see page 4243). Shen teaches that promising colorimetric detection results have been demonstrated using video cameras, digital color analyzers, scanner, and/or custom portable readers (see page 4240). The artisan would have reasonable expectation of success based on the cumulative disclosure of these prior art references at the time the instant application was filed.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678