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 .
Claim Status
The claim status of claims 1-16 is:
Claims 1-16 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/21/2025 and 04/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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, 4, 7, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mamenta (U.S. Patent Publication No 2014/0065647 presented in the IDS received 03/21/2025, hereinafter “Mamenta”) in view of Limberg et al. (WO 2020109525 A1 presented in the IDS received 04/30/2026).
Regarding claim 1, Mamenta discloses a determination method of determining a color expectation range for assessing the plausibility of an assumed reaction time value used in an analytical measurement based on a color formation reaction (Mamenta Abstract: “The invention relates to methods of reliably and quantitatively determining the amount of an analyte of interest in a fluid sample using a flow-induced assay”), the method comprising:
a) providing a training set of optical test strips each having a reagent test region (Mamenta [0018]: “c) an assay device, the assay device comprising a test area that displays a measurable spatiotemporal pattern in response to an application of the fluid sample, the spatiotemporal pattern providing information related to the amount of target analyte present in the applied fluid sample; Mamenta [0151]: “For example, a flow-induced assay strip designed to measure the levels of an analyte in a biological sample matrix (such as glucose in serum) may contain chemical or enzymatic reagents impregnated onto a membrane which generate an observable (chemical or enzymatic) spatiotemporal color pattern upon exposure to the sample. This pattern may be defined by analyte-dependent observations (such as a color signal on the membrane that darkens in relation to analyte concentration) and analyte-independent observations (such as non-uniform coloration across the membrane due to variable fluid flow patterns)”);
b) providing a training set of body fluid samples and applying at least one of the samples to the reagent test region of each optical test strip (Mamenta [0018]: “A further embodiment of the subject invention discloses a system for determining the amount of a target analyte in a fluid sample, comprising: a) a fluid sample; b) a plurality of fluid calibrator samples containing the target analyte at defined levels”);
c) capturing, by a mobile device having a camera (Mamenta [0018]: “d) an imaging instrument operatively connected to the assay device, wherein the imaging instrument is capable of collecting and recording the spatiotemporal pattern as a set of numerical spatiotemporal data points”; Mamenta [0153]: “In some embodiments the recorder and computer may constitute a single component. For example, a suitably housed and application fitted smartphone (containing a digital camera, light source and computer) may serve the function of both the spatiotemporal data recorder and computer”), a training set of images, comprising:
a first training subset of images comprising images of at least one part of at least some of the reagent test regions of the training set of optical test strips having the sample of body fluid applied thereto captured at in-time capture time values (Mamenta [0022]: “In embodiments of the subject invention, the information related to the flow dynamics of the assay device is derived from . . . or subsections of the capture zone, at defined time points”; Mamenta [0167]: “Images were captured at 5 second intervals, with Image 01 representing the first image captured, Image 02 representing the second image captured, etc.”);
a second training subset of images comprising images of at least one part of at least some of the reagent test regions of the training set of optical test strips having the sample of body fluid applied thereto captured at delayed capture time values (Mamenta [0022]: “In embodiments of the subject invention, the information related to the flow dynamics of the assay device is derived from . . . or subsections of the capture zone, at defined time points”; Mamenta [0168]: “At the time point captured by Image 03, the front of the flow stream has migrated through the capture zone and into the post-capture zone. As the flow stream continues migrating through the test area, the flow of particles through the capture zone results in particle binding within this zone, visible as a dark band about 5 mm from the left edge of the test area. The front of the flow stream can be tracked up until Image 16, at which point it migrates onto an absorbent pad. As the flow stream continues its migration onto the absorbent pad, particles continue to flow through the capture zone until a completion point is reached when particles are suitably bound within the capture zone and/or suitably depleted from the pre-capture and post-capture zones”);
d) determining a training set of color formation values from the images of the training set of images, the training set of color formation values comprising color formation values of a color channel for the color formation of the reagent test region of the optical test strips of the training set of optical test strips for in-time capture time values and for delayed capture time values (Mamenta [0151]: “For example, a flow-induced assay strip designed to measure the levels of an analyte in a biological sample matrix (such as glucose in serum) may contain chemical or enzymatic reagents impregnated onto a membrane which generate an observable (chemical or enzymatic) spatiotemporal color pattern upon exposure to the sample. This pattern may be defined by analyte-dependent observations (such as a color signal on the membrane that darkens in relation to analyte concentration) and analyte-independent observations (such as non-uniform coloration across the membrane due to variable fluid flow patterns). This analyte-independent variability, a potential source of erroneous result interpretations, could be addressed using spatiotemporal pattern analyses incorporated in the current invention”); and
e) deriving the color expectation range for the color channel from the training set of color formation values (Mamenta [0151]: “For example, a flow-induced assay strip designed to measure the levels of an analyte in a biological sample matrix (such as glucose in serum) may contain chemical or enzymatic reagents impregnated onto a membrane which generate an observable (chemical or enzymatic) spatiotemporal color pattern upon exposure to the sample. This pattern may be defined by analyte-dependent observations (such as a color signal on the membrane that darkens in relation to analyte concentration) and analyte-independent observations (such as non-uniform coloration across the membrane due to variable fluid flow patterns). This analyte-independent variability, a potential source of erroneous result interpretations, could be addressed using spatiotemporal pattern analyses incorporated in the current invention”), the color expectation range defining an expected range of color formation values for in-time capture time values and tolerably delayed capture time values (Mamenta [0143]: “In one embodiment, the completion time is determined by a threshold signal occurring in one or more areas of the image. For example, the assay may be deemed to have been completed once signal (resulting from the presence of test particles) is detected in a specific area of the post-capture zone”), wherein for the tolerably delayed capture time values the delay does not exceed at least one predefined expiry threshold dmax (Mamenta [0148]: “In still another application, the calibration dataset may be used to establish quality control thresholds, such as establishing a minimum and maximum time allowance for test particles to migrate from the particle zone to the capture zone, determined from signals measured in the pre-capture zone”).
Mamenta does not explicitly disclose the method comprising:
the capture time value referring to the time that has passed between the application of the sample in step b) and the capturing of the image.
However, Limberg teaches the method comprising:
the capture time value referring to the time that has passed between the application of the sample in step b) and the capturing of the image (Limberg Page 6: “estimating a point in time of sample application to the test field, by taking into account at least one first item of information derived from the image captured in step c)”).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the capture time as taught by Limberg with the method of Mamenta because it would allow for the method to determine the proper time to measure the analyte concentration (Limberg Page 4: “Thus, with customized detectors, the point in time of sample application on the test strip is usually known. The knowledge of the point in time of sample application usually facilitates the determination of the appropriate point in time for measuring the analyte concentration”). This motivation for the combination of Mamenta and Limberg is supported by KSR exemplary rationale (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention and rationale (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results.
Regarding claim 13, it is rejected under the same analysis as claim 1 above along with Mamenta’s disclosure of a system comprising a mobile device having a camera (Mamenta [0153]: “For example, a suitably housed and application fitted smartphone (containing a digital camera, light source and computer) may serve the function of both the spatiotemporal data recorder and computer”) and a processor (Mamenta [0153]: “For example, a suitably housed and application fitted smartphone (containing a digital camera, light source and computer) may serve the function of both the spatiotemporal data recorder and computer”).
Regarding claim 4, Mamenta discloses the method, wherein step d) further comprises labelling the color formation values of the training set of color formation values with information on the capture time values (Mamenta [0151]: “While the embodiments described herein have focused on the use of immunochromatographic assay devices, it should be understood that the invention is broadly applicable to other flow-induced assay devices, such as chemistry and enzymatic assay devices. For example, a flow-induced assay strip designed to measure the levels of an analyte in a biological sample matrix (such as glucose in serum) may contain chemical or enzymatic reagents impregnated onto a membrane which generate an observable (chemical or enzymatic) spatiotemporal color pattern upon exposure to the sample. This pattern may be defined by analyte-dependent observations (such as a color signal on the membrane that darkens in relation to analyte concentration) and analyte-independent observations (such as non-uniform coloration across the membrane due to variable fluid flow patterns). This analyte-independent variability, a potential source of erroneous result interpretations, could be addressed using spatiotemporal pattern analyses incorporated in the current invention”).
Regarding claim 7, Mamenta discloses the method, wherein step e) comprises using at least one machine-learning algorithm (Mamenta [0151]: “For example, a flow-induced assay strip designed to measure the levels of an analyte in a biological sample matrix (such as glucose in serum) may contain chemical or enzymatic reagents impregnated onto a membrane which generate an observable (chemical or enzymatic) spatiotemporal color pattern upon exposure to the sample. This pattern may be defined by analyte-dependent observations (such as a color signal on the membrane that darkens in relation to analyte concentration) and analyte-independent observations (such as non-uniform coloration across the membrane due to variable fluid flow patterns). This analyte-independent variability, a potential source of erroneous result interpretations, could be addressed using spatiotemporal pattern analyses incorporated in the current invention”).
Allowable Subject Matter
Claims 2-3, 5-6, 8-12, and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kumar et al. (U.S. Patent Publication No 2023/0146924) discloses methods and systems for using a neural network to analyze images of assay test strips using smartphone cameras (Kumar Abstract).
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/AIDAN KEUP/Examiner, Art Unit 2666 /Molly Wilburn/Primary Examiner, Art Unit 2666
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