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 .
Status of the Claims
Claims 1, 3, 5-19, and 21-24 are pending and examined herein.
Specification
The disclosure is objected to because of the following informalities:
The specification has received amendments introducing and then cancelling Figs 11, 15, and 16. Therefore, the specification needs a clean copy to eliminate layers of introduced and cancelled conflicting amendments.
Withdrawn Rejections
The rejections of claims 1, 3, 5-19 and 21-24 are withdrawn in view of Pre-Appeal Brief Conference decision mailed August 5, 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is “neural networks configured to generate one or more outputs” in claim 1.
The limitation meets the three-prong test as follows:
The generic placeholder is “neural networks”.
The functional language that modifies the generic placeholder is “configured to generate one or more outputs”.
The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed functions. No structural limitations are provided in the claims for performing the function. The specification fails to disclose structures for the recited neural networks.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted as software performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5-19, and 21-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea performed on a generic computer and a naturally occurring correlation.
Claim 1 is directed to a process, which belongs to the four statutory categories.
The claim is related to a method of establishing relationship between the amount or concentration of one or more analytes in a sample and a diagnostic decision or classification of the sample. This relationship is categorized as a naturally occurring correlation, and therefore it is a judicial exception.
The claim also recites the steps of imaging a cartridge membrane, subjecting the images to image processing, and inputting the normalized pixel intensity values for calculations. The steps are recited as being processed with a processing software on a generic computing device.
The image analysis step is recited at a high level of generality. Therefore, it is categorized as mathematical calculations.
The steps of normalizing pixel intensity values, inputting the values to neural networks, and processing the values by neural networks are mathematical calculations. The plain meaning of these terms are calculation algorithms, performed by the generic computing device using a series of mathematical calculations.
The steps of imaging a cartridge membrane, subjecting the images to image processing, and inputting the normalized pixel intensity values for calculations are also insignificant extra-solution activity required to transfer data existing in the form of spots on the sensing membrane into a computer format for further processing.
The claim recites the following additional steps: (i) quantify the amount or concentration of the one or more analytes in the sample – this step is recited at a high level of generality and categorized as a mathematical calculation; (ii) indicate the presence of the one or more analytes in the sample – this step is comparing the measured analyte amount to a set threshold value and making a conclusion of the analyte being present or absent in the sample; (iii) determine a diagnostic decision or classification of the sample - the “determining” step is data analysis step performed in human mind, which is a mental process.
The limitation (i) falls into the “mathematical concepts” groupings of abstract ideas and the limitations (ii) and (iii) fall into the “mental process” groupings of abstract ideas. Therefore, all are judicial exceptions.
The claim recites additional steps of providing a flow assay cartridge and loading a sample and reagent mixture. These steps are considered insignificant extra-solution activities that amounts to mere data gathering necessary to apply the judicial exception. They are recited at a high level of generality and have been recognized as routine laboratory techniques.
The wherein clause of claim 1 recites the pre-defined spot map of spot locations and spot conditions comprise a plurality of immunoreaction or biological reaction spots having spatial locations and spot conditions optimized for neural network-based analysis, quantification, and/or diagnosis. The plain meaning of the map is information about spots locations optimized for mathematical calculations. Therefore, the clause is categorized as an abstract idea for mathematical calculations.
The second wherein clause of claim 1 recites the pre-defined spot map is determined by machine learning-based optimization. The plain meaning of the map is information about spots locations determined by mathematical calculations. Therefore, the clause is categorized as an abstract idea optimized by mathematical calculations.
When considering the elements in combination, the claim as a whole does not integrate the recited exceptions into a practical application and the claim is directed to the judicial exception. Additionally, the claim does not recite any practical application.
Claim 1 as a whole does not amount to significantly more than the recited exceptions. There are no additional elements, or combination of additional elements, adding an inventive concept to the claim.
The additional steps of imaging a cartridge membrane, image processing, and inputting the pixel intensity values for calculations are insignificant extra-solution activity required to transfer data existing in the form of spots on a sensing membrane into a computer format for further processing. This activity is well understood, routine, and conventional in the field of immunoassays. For example, microplate or microarray readers routinely take images of microplates or microarrays and process pixel intensity values into amounts or concentrations of analytes.
The additional steps of (i) quantifying the amount or concentration of the one or more analytes in the sample; (ii) indicating the presence of the one or more analytes in the sample – this step is comparing the measured analyte amount to a defined threshold value and making a conclusion of the analyte being present or absent in the sample; and (iii) determining a diagnostic decision or classification of the sample are also well understood, routine, and conventional in the field of immunoassays or clinical instrumental assays. Results of routine blood tests are subjected to quantifying the amount or concentration, indicating the presence or absence of the analyte, and classifying the sample as normal or a sample outside the normal range values.
The additional steps of providing a flow assay cartridge and loading a sample and reagent mixture have been recognized as routine laboratory techniques in vertical flow assays.
The pre-defined spot map of spot locations and spot conditions is well understood, routine, and conventional in the field of microplate or membrane assays because it is due to this map that the processing software knows which data to use as calibration data and which as experimental sample data. For example, commercial microplate readers provide a software tool to map controls, calibrators, and experimental samples.
Even when considered in combination, these additional elements represent mere instructions to implement an abstract idea or other exception on a computer and insignificant extra-solution activity, which do not provide an inventive concept.
Dependent claims 3, 5-19, and 21-24 recite well-known steps and procedures recognized as routine laboratory techniques. For example, claim 3 recites the amount or concentration of the one or more analytes is either qualitative or quantitative; claim 5 recites a well-known analyte – C-reactive protein (Oh et al. (Lab Chip. 2013 Mar 7;13(5):768-72) teach a method for one-step determination of C-reactive protein using a vertical flow immunoassay biosensor (Abstract)); and claim 6 - the reader device further comprises a portable electronic device having a camera e.g., a smartphone).
The dependent claims 2, 8-11, and 22-34 fail to add additional elements, or combination of additional elements, that contribute to an inventive concept to the claim because there are no additional elements, or combination of additional elements, that add an inventive concept to the claims and are not routine and conventional.
For these reasons, claims 1, 3, 5-19, and 21-24 are ineligible under 35 U.S.C. 101.
Response to Arguments
Applicant’s arguments filed May 20, 2026 have been fully considered.
The rejections of claims 1, 3, 5-19 and 21-24 are withdrawn in view of Pre-Appeal Brief Conference decision mailed August 5, 2026, therefore, all arguments are moot.
Subject Matter Free of the Prior Art
Claims 1, 3, 6-14, and 21-24 are free of the prior art.
The prior art neither teaches nor suggests a method of claim 1, wherein the pre-defined spot map is determined by machine learning-based optimization.
The closest prior art of Chen et al. (IDS; Talanta. 2019 Jan 1; 191:81-88) in view of Hamamci et al. (IDS; WO 2018194525), and as evidenced by Amazon (Canon CS9000F MKII, 2012, p.1-7) teach claim 1 limitations but fail to teach the last limitation of claim 1 reciting “wherein the pre-defined spot map is determined by machine learning-based optimization”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/
Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
