DETAILED ACTION
Response to Amendment
This action is in response to the amendment filed on July 7, 2025. Claims 1, 10, and 21 have been amended. Claims 29 has been added. Claim 28 has been cancelled. Claims 1-17, 21-27, and 29 have been examined and are currently pending.
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 .
Inventorship
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.
Information Disclosure Statement
The Information Disclosure Statement filed on July 15, 2025 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
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 1-17, 21-27, and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
ALICE/ MAYO: TWO-PART ANALYSIS
2A. First, a determination whether the claim is directed to a judicial exception (i.e., abstract idea).
Prong 1: A determination whether the claim recites a judicial exception (i.e., abstract idea).
Groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Mathematical concepts- mathematical relationships, mathematical formulas or equations, mathematical calculations.
Certain methods of organizing human activity- fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions).
Mental processes- concepts performed in the human mind (including an observation, evaluation, judgement, opinion).
Prong 2: A determination whether the judicial exception (i.e., abstract idea) is integrated into a practical application.
Considerations indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception
Considerations that are not indicative of integration into a practical application enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
2B. Second, a determination whether the claim provides an inventive concept (i.e., Whether the claim(s) include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
Considerations indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Improvement to the functioning of a computer, or an improvement to any other technology or technical field
Applying the judicial exception with, or by use of a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception NOTE: The only consideration that does not overlap with the considerations indicative of integration into a practical application associated with step 2A: Prong 2.
Considerations that are not indicative of an inventive concept (aka “significantly more”) enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance.
Merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.
Adding insignificant extra-solution activity to the judicial exception.
Generally linking the use of the judicial exception to a particular technological environment or field of use.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. NOTE: The only consideration that does not overlap with the considerations that are not indicative of integration into a practical application associated with step 2A: Prong 2.
See also, 2019 Revised Patent Subject Matter Eligibility Guidance; Federal Register; Vol. 84, No. 4; Monday, January 7, 2019
Claims 1-17, 21-27, and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
1: Statutory Category
Applicant’s claimed invention, as described in independent claim 1 is directed to a system and independent claim 11 is directed to a method.
2(A): The claim(s) are directed to a judicial exception (i.e., an abstract idea).
PRONG 1: The claim(s) recite a judicial exception (i.e., an abstract idea).
Mental Processes
Independent claims 1 and 10 recite the limitation, “the processor further to determine an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the identified test configuration profile.” which is directed to the abstract idea of mental processes. Specifically, the claims are directed to concepts performed in the human mind (e.g., observation, evaluation, and judgment). In the currently pending claims, a person can determine LFA test results by visually observing, evaluating, and comparing the intensity value to an intensity threshold value.
Independent claim 21 recites the limitations, “identifying a first test configuration profile based on the visual feature, wherein the visual feature comprises: identification of a manufacturer and identification of a test to be performed; and evaluating an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the first test configuration profile.” which is directed to the abstract idea of mental processes. Specifically, the claims are directed to concepts performed in the human mind (e.g., observation, evaluation, and judgment). In the currently pending claims, a person can determine LFA test results by visually observing, evaluating, and comparing the intensity value to an intensity threshold value. Additionally, a person can determine a configuration profile based on observing and evaluating the visual feature.
Mathematical Concepts
Independent claims 1 and 10 recite the limitation, “the processor further to determine an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the identified test configuration profile.” is directed to the abstract idea of mathematical concepts. In particular, the limitation recites using mathematical relationships and mathematical calculations determine an LFA test result based on using mathematical relationship of comparing numerical values of a measured intensity value to an intensity threshold value.
Mathematical Concepts
Independent claim 21 recites the limitation, “evaluating an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the first test configuration profile.” is directed to the abstract idea of mathematical concepts. In particular, the limitation recites using mathematical relationships and mathematical calculations determine an LFA test result based on using mathematical relationship of comparing numerical values of a measured intensity value to an intensity threshold value.
PRONG 2: The judicial exception (i.e., an abstract idea) is not integrated into a practical application.
The applicant has not shown or demonstrated any of the requirements described above under "integration into a practical application" under step 2A. Specifically, the applicant's limitations are not "integrated into a practical application" because they are adding words "apply it" with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)). Additionally, improvements to the functioning of a computer or any other technology or technical field has not been shown or disclosed (see MPEP 2106.05(a)). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, the applicant’s limitations are not “significantly more” because they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea (see MPEP 2106.05(f)) and generally linking use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). The applicant’s claimed limitations do not demonstrate an improvement to another technology or technical field, an improvement to the functioning of the computer itself, effecting a transformation or reduction of particular article to a different state or thing. The current application does not amount to 'significantly more' than the abstract idea as described above. The claim does not include additional elements or limitations individually or in combination that are sufficient to amount to significantly more than the judicial exception. Specifically, the individual elements of a processor, memory, LFA strip reader, and display screen, amount to no more than implementing an idea with a computerized system and they are adding words “apply it” with the judicial exception, or mere instructions to implement an abstract idea merely as a tool to perform an abstract idea. The additional elements taken in combination add nothing more than what is present when the elements are considered individually. Therefore, based on the two-part Alice Corp. analysis, there are no meaningful limitations in the claims that transform the exception (i.e., abstract idea) into a patent eligible application.
Since the claim(s) recite a judicial exception and fails to integrate the judicial exception into a practical application, the claim(s) is/are “directed to” the judicial exception. Thus, the claim(s) must be reviewed under the second step of the Alice/ Mayo analysis to determine whether the abstract idea has been applied in an eligible manner.
2(B): The claims do not provide an inventive concept (i.e., The claim(s) do not include additional elements, or combinations of elements, that are sufficient to amount to significantly more than the judicial exception (i.e., abstract idea)).
As discussed with respect to Step 2A Prong Two, the additional element(s) in the claim amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
For these reasons, there is no invention concept in the claim, and thus the claim is ineligible.
Dependent claims 2-9, 11-17, 22-27 and 29 are rejected as ineligible subject matter under 35 U.S.C. 101 based on a rationale similar to the claims from which they depend.
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.
Claim(s) 1-4, 7, 10-16, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Somes et al. US Publication 20200386753 A1 in view of Fleming et al. US Publication 20100045789 A1 in view of Ehrenkranz US Publication 20150338387 A1 further in view of Kelly et al. US Publication 20180071741 A1.
Claim 1:
As per claim 1, Somes teaches a system comprising:
a processor (paragraphs 0044, 0056 “As illustrated, the substrate reader 100 may include processor(s) 124 and memory 126, which stores or otherwise has access to a substrate test strip database 128, a cartridge database 130, and/or an analyte database 132.”);
a carrier for receiving a lateral flow assay ("LFA") strip for testing (paragraphs 0019, 0036, 0069, 0093 “For example, in an embodiment, the housing may include a drawer, canister, port, or slide configured to receive the substrate test strip. In an embodiment, the substrate test strip is contained within a cartridge that holds the substrate test strip. In an embodiment, the substrate reader may receive a plurality of cartridges and/or different types of cartridges, such as cups (e.g., smart cup with embedded test strip), container, cassettes, dip cards, etc. for holding various fluids, samples, or substrate test strips. For example, as cartridges include different shapes, sizes, and geometries, the slide may include pins, fins, protrusions, flanges, shelves, or other receptacles configured to receive and hold various types of cartridges, containers, or samples.”);
Somes does not teach memory coupled to the processor for storing a local testing database having a test configuration profile including an intensity threshold value denoting a minimum intensity value that indicates a positive test result. However, Fleming teaches an Apparatus, Method, and Article to Perform Assay using Assay Strips and further teaches, “The system bus 216 can employ any known bus structures or architectures, including a memory bus with memory controller, a peripheral bus, and a local bus. The system memory 214 includes read-only memory ("ROM") 218 and random access memory ("RAM") 220.” (paragraph 0110), “FIG. 13 shows a method 1300 of receiving user input according to another illustrated embodiment. At 1302, the assay device receives user input indicative of a threshold intensity level for positive result signal lines. The user input may be entered by a user via a user input device.” (paragraph 0193), “At 1602, the assay device receives a value indicative of an assay strip manufacturer. Such may be logically associated with one or more characteristics of the assay strip, for example, physical format including overall dimensions, number and/or position of positive result signal lines, control signal lines, colors, intensity, and/or dimensions of signal lines. The user input may be entered by a user via a user input device or may be scanned or otherwise read using automatic data collection equipment (e.g., machine-readable symbol reader, RFID reader or interrogator, magnetic stripe reader, etc.).” (paragraph 0197), “FIG. 35 shows a portion 3500 of a graphical user interface which may be displayed by an assay device or supporting computer, according to one illustrated embodiment. The portion 3500 of the user interface includes a user-selectable manufacturer selection tab 3502 which may appear on a control bar of a user interface. Selection of the manufacturer selection tab 3502 causes the presentation of a manufacturer pull-down menu 3504, which displays a list of assay strip manufacturers or distributors 3506 (only one called out in FIG. 35). A user selectable sub-menu icon 3508 is present if there are multiple options for a given assay strip manufacturer or distributor 3506. Selection of the sub-menu icon 3508 causes presentation of a model pull-down menu 3510. The model pull-down menu 3510 presents a user selectable model icon 3512a, 3512b for each model of assay strips produced or sold by the manufacturer or distributor. Selection of a model icon 3512a, 3512b causes the assay device to retrieve specific parameters and variables for the selected assay strip product and to configure the processor executable instructions to perform assays based on the retrieved parameters and variables. The specific parameters and variable for different products may be stored at the assay device, or may be stored remotely therefrom. In some embodiments, that assay device may automatically query manufacturers or distributors (e.g., Website) for specific parameters and variables in response to the selection. In some embodiments, manufacturer/distributors (e.g., server) may transmit (i.e., push) specific parameters and variables to assay devices as products are updated or introduced. This may eliminate the need for the operator or end user to download (i.e., pull) such parameters and variables.” (paragraph 0219). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include memory coupled to the processor for storing a local testing database having a test configuration profile including an intensity threshold value denoting a minimum intensity value that indicates a positive test result as taught by Fleming in order to maintain a record of different parameters associated with different types of tests.
Somes does not teach the processor further to determine the LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the identified test configuration profile. However, Fleming teaches an Apparatus, Method, and Article to Perform Assay using Assay Strips and further teaches, “At 1066, the processor(s) determines whether the control and test results signal lines are present on the assay strip in the acquired image. For example, the processor(s) may compare control and test line densities against thresholds (e.g., factory-calibrated thresholds). Such results in a categorical assessment of the assay strip. For example, if both the control and test results signal lines are determined to be present, the assay strip is deemed "Positive". If the control signal line is present but the test results signal line is absent, the assay strip is deemed "Negative". If the control signal line is absent, the assay strip is deemed "Blank".” (paragraph 0179). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include the processor further to determine the LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the identified test configuration profile as taught by Fleming in order to determine test results based on specific parameters associated with a specific manufacturer/test.
Somes and Fleming do not teach an LFA strip reader coupled to the processor for reading the LFA strip and a visual feature and transmitting an LFA strip image and the visual feature to a processor, wherein the visual feature comprises: identification of a manufacturer and identification of a test to be performed. However, Ehrenkranz teaches Supplements and Monitoring Systems for Dosing of the Supplements and further teaches, “In addition, the packaging system 600 includes a tracking code 630. In the illustrated embodiment, the tracking code 630 is a QR code, which is a two-dimensional bar code. Two-dimensional bar codes, like QR codes, can be used to store far more information that can be stored in a conventional bar code. For example, a QR code can be used to store up ˜4300 alphanumeric characters (i.e., 0-9, A-Z, space, $, %, *, +, -, ., /, :, etc.). In one embodiment, the tracking code 630 can be read by the diagnostic testing system prior to initiating a test. The tracking code may be used to store information that is relevant to the test in a format that can be read by the device. For example, the tracking code 630 can be used for recording and then transmitting to the test system the values for the calibration standards used on the lateral-flow chromatographic assay cassette 610, manufacturer, date of manufacture, lot number for the lateral-flow chromatographic assay cassette 610, manufacturer, date of manufacture, and sample/results tracking.” (paragraph 0122) and “…Additionally the front-directed camera can be used for imaging QR and bar code information identifying the test to be performed and providing lot number, expiration date, and control values as well as other parameters as needed for test identification, calibration, results interpretation, and data reporting.” (paragraph 0102). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include an LFA strip reader coupled to the processor for reading the LFA strip and a visual feature and transmitting an LFA strip image and the visual feature to a processor, wherein the visual feature comprises: identification of a manufacturer and identification of a test to be performed as taught by Ehrenkranz in order to determine the manufacturer of the lateral flow assay and the corresponding test to be performed.
Somes, Fleming, and Ehrenkranz do not teach the processor to identify a test configuration profile for the LFA strip based on the visual feature. However, Kelly teaches a Diagnostic Assay Strip Cassette and further teaches, “In this or any other implementation, when a cassette is used with a specimen analysis system or machine reader, the specimen analysis system or machine reader may be used to automatically or autonomously read machine-readable information carried by the cover and/or the base of the cassette. Such optically encoded data/indicia may include one of or a combination of machine readable symbols such as barcode symbols, matrix or area code symbols, stacked code symbols, and the like. The machine-readable data can include the type of test strip being used, the manufacturer thereof, and any other information considered pertinent or desired. Other data and indicia may be read using alternative methods and systems in addition to the optically encoded data or indicia. Such systems are described in detail in U.S. Pat. No. 8,446,463 which is incorporated herein by reference in its entirety. The specimen analysis system or machine reader can employ the read information in properly automatically performing analysis of the diagnostic assay test strip, for example selecting between a variety of algorithms and/or parameters and determining assay or test results based on the detected optical properties or characteristics of the diagnostic assay test strip (e.g., presence or absence of lines, color of lines) using the selected algorithm and/or based on the selected parameters. This can allow a single specimen analysis system or machine reader to autonomously be used to read a variety types of diagnostic assay test strip, without a need for an end user to program the specimen analysis system or machine reader according to the particular type of diagnostic assay test strip.” (paragraph 0056). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include the processor to identify a test configuration profile for the LFA strip based on the visual feature as taught by Kelly in order to perform a specific test with specific parameters.
Claim 10:
As per claim 10, Somes teaches the system comprising:
a processor (paragraphs 0044, 0056 “As illustrated, the substrate reader 100 may include processor(s) 124 and memory 126, which stores or otherwise has access to a substrate test strip database 128, a cartridge database 130, and/or an analyte database 132.”);
a carrier for receiving a cassette containing a lateral flow assay ("LFA") strip (paragraphs 0019, 0036, 0069, 0093 “For example, in an embodiment, the housing may include a drawer, canister, port, or slide configured to receive the substrate test strip. In an embodiment, the substrate test strip is contained within a cartridge that holds the substrate test strip. In an embodiment, the substrate reader may receive a plurality of cartridges and/or different types of cartridges, such as cups (e.g., smart cup with embedded test strip), container, cassettes, dip cards, etc. for holding various fluids, samples, or substrate test strips. For example, as cartridges include different shapes, sizes, and geometries, the slide may include pins, fins, protrusions, flanges, shelves, or other receptacles configured to receive and hold various types of cartridges, containers, or samples.”);
and a display screen coupled for displaying LFA test results (paragraphs 0052 and 0104 “For example, the output device(s) 146 may include a display screen that displays results of the image processing indicating the presence and/or concentration of the analyte.”);
and a display screen to display the LFA test result on the display screen (paragraphs 0052 and 0104 “For example, the output device(s) 146 may include a display screen that displays results of the image processing indicating the presence and/or concentration of the analyte.”).
Somes does not teach memory coupled to the processor for storing a local testing database having a plurality of test configuration profiles with each test configuration profile having an intensity threshold value denoting a minimum intensity value that indicates a positive test result. However, Fleming teaches an Apparatus, Method, and Article to Perform Assay using Assay Strips and further teaches, “The system bus 216 can employ any known bus structures or architectures, including a memory bus with memory controller, a peripheral bus, and a local bus. The system memory 214 includes read-only memory ("ROM") 218 and random access memory ("RAM") 220.” (paragraph 0110), “FIG. 13 shows a method 1300 of receiving user input according to another illustrated embodiment. At 1302, the assay device receives user input indicative of a threshold intensity level for positive result signal lines. The user input may be entered by a user via a user input device.” (paragraph 0193), “At 1602, the assay device receives a value indicative of an assay strip manufacturer. Such may be logically associated with one or more characteristics of the assay strip, for example, physical format including overall dimensions, number and/or position of positive result signal lines, control signal lines, colors, intensity, and/or dimensions of signal lines. The user input may be entered by a user via a user input device or may be scanned or otherwise read using automatic data collection equipment (e.g., machine-readable symbol reader, RFID reader or interrogator, magnetic stripe reader, etc.).” (paragraph 0197), “FIG. 35 shows a portion 3500 of a graphical user interface which may be displayed by an assay device or supporting computer, according to one illustrated embodiment. The portion 3500 of the user interface includes a user-selectable manufacturer selection tab 3502 which may appear on a control bar of a user interface. Selection of the manufacturer selection tab 3502 causes the presentation of a manufacturer pull-down menu 3504, which displays a list of assay strip manufacturers or distributors 3506 (only one called out in FIG. 35). A user selectable sub-menu icon 3508 is present if there are multiple options for a given assay strip manufacturer or distributor 3506. Selection of the sub-menu icon 3508 causes presentation of a model pull-down menu 3510. The model pull-down menu 3510 presents a user selectable model icon 3512a, 3512b for each model of assay strips produced or sold by the manufacturer or distributor. Selection of a model icon 3512a, 3512b causes the assay device to retrieve specific parameters and variables for the selected assay strip product and to configure the processor executable instructions to perform assays based on the retrieved parameters and variables. The specific parameters and variable for different products may be stored at the assay device, or may be stored remotely therefrom. In some embodiments, that assay device may automatically query manufacturers or distributors (e.g., Website) for specific parameters and variables in response to the selection. In some embodiments, manufacturer/distributors (e.g., server) may transmit (i.e., push) specific parameters and variables to assay devices as products are updated or introduced. This may eliminate the need for the operator or end user to download (i.e., pull) such parameters and variables.” (paragraph 0219). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include memory coupled to the processor for storing a local testing database having a test configuration profile including an intensity threshold value denoting a minimum intensity value that indicates a positive test result as taught by Fleming in order to maintain a record of different parameters associated with different types of tests.
Somes does not teach and determine an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the first test configuration profile. However, Fleming teaches an Apparatus, Method, and Article to Perform Assay using Assay Strips and further teaches, “At 1066, the processor(s) determines whether the control and test results signal lines are present on the assay strip in the acquired image. For example, the processor(s) may compare control and test line densities against thresholds (e.g., factory-calibrated thresholds). Such results in a categorical assessment of the assay strip. For example, if both the control and test results signal lines are determined to be present, the assay strip is deemed "Positive". If the control signal line is present but the test results signal line is absent, the assay strip is deemed "Negative". If the control signal line is absent, the assay strip is deemed "Blank".” (paragraph 0179). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include the processor further to determine an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value of the first test configuration profile as taught by Fleming in order to determine test results based on specific parameters associated with a specific manufacturer/test.
Somes and Fleming do not teach an LFA strip reader coupled to the processor for reading the LFA strip and a visual feature of the cassette and transmitting an LFA strip image and the visual feature to the processor, wherein the visual feature comprises: identification of a manufacturer and identification of a test to be performed. However, Ehrenkranz teaches Supplements and Monitoring Systems for Dosing of the Supplements and further teaches, “In addition, the packaging system 600 includes a tracking code 630. In the illustrated embodiment, the tracking code 630 is a QR code, which is a two-dimensional bar code. Two-dimensional bar codes, like QR codes, can be used to store far more information that can be stored in a conventional bar code. For example, a QR code can be used to store up ˜4300 alphanumeric characters (i.e., 0-9, A-Z, space, $, %, *, +, -, ., /, :, etc.). In one embodiment, the tracking code 630 can be read by the diagnostic testing system prior to initiating a test. The tracking code may be used to store information that is relevant to the test in a format that can be read by the device. For example, the tracking code 630 can be used for recording and then transmitting to the test system the values for the calibration standards used on the lateral-flow chromatographic assay cassette 610, manufacturer, date of manufacture, lot number for the lateral-flow chromatographic assay cassette 610, manufacturer, date of manufacture, and sample/results tracking.” (paragraph 0122) and “…Additionally the front-directed camera can be used for imaging QR and bar code information identifying the test to be performed and providing lot number, expiration date, and control values as well as other parameters as needed for test identification, calibration, results interpretation, and data reporting.” (paragraph 0102). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include an LFA strip reader coupled to the processor for reading the LFA strip and a visual feature and transmitting an LFA strip image and the visual feature to a processor, wherein the visual feature comprises: identification of a manufacturer and identification of a test to be performed as taught by Ehrenkranz in order to determine the manufacturer of the lateral flow assay and the corresponding test to be performed.
Somes, Fleming, and Ehrenkranz do not teach the processor further to determine a first test configuration profile based on the visual feature. However, Kelly teaches a Diagnostic Assay Strip Cassette and further teaches, “In this or any other implementation, when a cassette is used with a specimen analysis system or machine reader, the specimen analysis system or machine reader may be used to automatically or autonomously read machine-readable information carried by the cover and/or the base of the cassette. Such optically encoded data/indicia may include one of or a combination of machine readable symbols such as barcode symbols, matrix or area code symbols, stacked code symbols, and the like. The machine-readable data can include the type of test strip being used, the manufacturer thereof, and any other information considered pertinent or desired. Other data and indicia may be read using alternative methods and systems in addition to the optically encoded data or indicia. Such systems are described in detail in U.S. Pat. No. 8,446,463 which is incorporated herein by reference in its entirety. The specimen analysis system or machine reader can employ the read information in properly automatically performing analysis of the diagnostic assay test strip, for example selecting between a variety of algorithms and/or parameters and determining assay or test results based on the detected optical properties or characteristics of the diagnostic assay test strip (e.g., presence or absence of lines, color of lines) using the selected algorithm and/or based on the selected parameters. This can allow a single specimen analysis system or machine reader to autonomously be used to read a variety types of diagnostic assay test strip, without a need for an end user to program the specimen analysis system or machine reader according to the particular type of diagnostic assay test strip.” (paragraph 0056). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include the processor further to determine a first test configuration profile based on the visual feature as taught by Kelly in order to perform a specific test with specific parameters.
Claim 2:
As per claim 2, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above and Fleming further teaches wherein the system further comprises:
a communications interface for communicating with a central patient database (paragraph 0224). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include a communications interface for communicating with a central patient database as taught Fleming in order to facilitate exchange of information associated with a patient.
a patient identification reader for reading a patient identifier (paragraph 0224). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include a patient identification reader for reading a patient identifier as taught by Fleming in order to easily identify or capture data associated with a patient.
and the processor further configured to associate the LFA test result and the LFA strip image with the patient identifier and upload the LFA test result and LFA strip image to the central patient database (paragraphs 0224-0226). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include the processor further configured to associate the LFA test result and the LFA strip image with the patient identifier and upload the LFA test result and LFA strip image to the central patient database as taught by Fleming in order to maintain the central patient database updated with the latest test results.
Claim 3:
As per claim 3, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above and Kelly further teaches wherein the visual feature is on a cassette carrying the LFA strip (paragraphs 0051 and 0056). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include wherein the visual feature is on a cassette carrying the LFA strip as taught by Kelly in order to capture data associated with the cassette.
Claim 4:
As per claim 4, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above and Somes further teaches wherein the LFA strip reader comprises a plurality of LED lights activated based on the test configuration profile and a camera for reading the LFA strip and generating the LFA strip image (paragraph 0059).
Claim 7:
As per claim 7, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above and Somes further teaches wherein the carrier is replaceable within the system in order to accommodate a variety of configurations for a cassette holding the LFA strip (paragraph 0019).
Claim 11:
As per claim 11, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 10 as described above and Fleming further teaches wherein the system further comprises:
a communications interface for communicating with a central test database (paragraph 0224). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include a communications interface for communicating with a central patient database as taught Fleming in order to facilitate exchange of information associated with a patient.
and the processor further configured to download from the central test database a test for storage in the local testing database when the visual feature is not associated with any of the plurality of test configuration profiles in the local testing database (paragraphs 0219 and 0234). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include and the processor further configured to download from the central test database a test for storage in the local testing database when the visual feature is not associated with any of the plurality of test configuration profiles in the local testing database as taught by Fleming in order to provide an additional test configuration profile.
Claim 12:
As per claim 12, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 10 as described above and Fleming further teaches wherein the system further comprises:
a communications interface for communicating with a central patient database (paragraph 0224). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include a communications interface for communicating with a central patient database as taught Fleming in order to facilitate exchange of information associated with a patient.
a patient identification reader for reading a patient identifier (paragraph 0224). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include a patient identification reader for reading a patient identifier as taught by Fleming in order to easily identify or capture data associated with a patient.
and the processor further configured to associate the LFA test result and the LFA strip image with the patient identifier (paragraphs 0224-0226). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include and the processor further configured to associate the LFA test result and the LFA strip image with the patient identifier as taught by Fleming in order to ensure the test result, test strip image, and patient identifier correspond to a particular patient.
and the processor further configured to upload the LFA test result and LFA strip image to the central patient database (paragraph 0224-0226). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include and the processor further configured to upload the LFA test result and LFA strip image to the central patient database as taught by Fleming in order to maintain the central patient database updated with the latest test results.
Claim 13:
As per claim 13, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 10 as described above and Fleming further teaches wherein the LFA test result shown by the display screen comprises one of: a positive, a negative, or an invalid LFA test result (paragraph 0166). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include wherein the LFA test result shown by the display screen comprises one of: a positive, a negative, or an invalid LFA test result as taught by Fleming in order present information regarding test results.
Claim 14:
As per claim 14, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 10 as described above and Somes further teaches wherein the carrier is configured to fit a cassette, and the carrier is replaceable to accommodate a different cassette (paragraph 0019).
Claim 15:
As per claim 15, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 10 as described above and Fleming further teaches comprising a patient card reader coupled to the processor for reading a patient identification card and providing patient information to the processor (paragraphs 0224-0227). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to further comprising a patient card reader coupled to the processor for reading a patient identification card and providing patient information to the processor as taught by Fleming in order to retrieve patient data and display the test results.
Claim 16:
As per claim 16, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 15 as described above and Fleming further teaches wherein the display screen is further operable to display a first set of patient component information from the patient information (paragraphs 0224-0227). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include wherein the display screen is further operable to display a first set of patient component information from the patient information as taught by Fleming in order to present relevant patient data.
Claim 29:
As per claim 29, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above and Kelly further teaches wherein the visual identifier further comprises: a test profile configuration code (paragraph 0056). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include wherein the visual identifier further comprises: a test profile configuration code as taught by Kelly in order to determine the type of test to be performed.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Somes, Fleming, Ehrenkranz, and Kelly as applied to claims 1 above, and further in view of Taran US Publication 20210263018 A1.
Claims 5:
As per claim 5, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above but do not teach wherein the visual feature is on the LFA strip. However, Taran teaches Lateral Flow Test Strip Immunoassay in Vitro Diagnostic Device and further teaches, “FIG. 7 shows an exploded view of a cartridge (703) held inside a cartridge carrying adaptor (704). The cartridge contains one or more test strips (705). In this example, the cartridge has been configured to receive 6 test strips. Each test strip is associated with a QR code (706) that is engraved or printed on the cartridge.” (paragraph 0117). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include wherein the visual feature is on the LFA strip as taught by Taran in order to easily identify the LFA strip. However, Taran teaches Lateral Flow Test Strip Immunoassay in Vitro Diagnostic Device and further teaches, “FIG. 7 shows an exploded view of a cartridge (703) held inside a cartridge carrying adaptor (704). The cartridge contains one or more test strips (705). In this example, the cartridge has been configured to receive 6 test strips. Each test strip is associated with a QR code (706) that is engraved or printed on the cartridge.” (paragraph 0117). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Somes to include wherein the visual feature is on the LFA strip as taught by Taran in order to easily identify the LFA strip.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Somes, Fleming, Ehrenkranz, and Kelly as applied to claim 1 above, and further in view of Paul et al. US Publication 20160030613 A1.
Claim 6:
As per claim 6, Somes, Fleming, Ehrenkranz, and Kelly teach the system of claim 1 as described above but do not teach wherein the system further comprises a light emitting device for sterilizing at least a portion of the carrier that receives the LFA strip. However, Paul teaches an Apparatus for the Disinfection of Medical Instruments and further teaches “FIG. 5 is a cross section view of a disinfection cradle 22 holding a BGM 16 according to some embodiments. The disinfection cradle 22 can be equipped with UV LEDs 4b and UV lens 4a which deliver a controlled dose of ultraviolet light in a manner previously described. Additionally, UV LEDs 32 may be incorporated within the BGM 16 immediately inside of the strip port 36, or within other locations. The UV LED(s) are placed within the BGM housing so that direct UV light from these LED(s) reaches all or most of the surfaces in direct contact with a test strip. In some embodiments, the UV LEDs 4b are active when the test strip is not inserted. Alternatively, in some embodiments the lens 4a can direct UV light away from any sensitive area of the test strip (namely the chemistry area) when the test strip is inserted, including the electrical contacts interfacing with the strip. Placing UV LEDs 32 within the BGM 16 can help disinfect bio-burden in locations beyond the reach of the conventional wet-towel cleaners, since the action of these cleaners is limited to the exterior surfaces