DETAILED ACTION
Applicant's Remarks, filed 09/09/2025, have been fully considered in view of instant application amendments. Herein, "the previous Office action" refers to the Nonfinal Rejection of 06/06/2025.
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 Claims
Claims 1 and 3-24 are currently pending and under examination herein.
Claim 2 is previously cancelled.
Claims 1 and 3-24 are rejected.
Information Disclosure Statement
The Information Disclosure Statement, filed 10/22/2025, has been considered. A signed copy of all IDS is included with this Office Action
Priority
As previously discussed, no claim for priority benefit. Therefore, all claims 1 and 3-24 are examined for an effective filing date of 10/25/2020. In future actions, the effective filing date of one or more claims may change, due to claim amendments, or further analysis of the disclosure(s) of the priority application(s).
Withdrawn Rejections/Objections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn in view of the 09/09/2025 amendments and Applicant’s remarks. Upon further consideration, newly applied rejections/portions are necessitated by the instant amendments are discussed below.
Regarding claim 15 discussed under 35 U.S.C. 101 step 1, claim 15 was amended to “non-transitory computer readable storage medium” to further clarify the non-transitory nature of the claimed computer program product. Upon further consideration of 101, independent claim 15 and dependent claims are rejected under 35 U.S.C. 101 step 2A(1), for instruction claims directed to judicial exceptions as discussed below.
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[e], subject to the conditions and requirements of this title.
Claims 4-6, 8, and 11-20 are rejected under 35 U.S.C. 101, because the claimed invention is directed to an abstract idea without significantly more.
The instant rejection reflects the framework as outlined in the MPEP at 2106.04:
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture, or composition of matter;
(2A) Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With respect to step (1): Yes. The claimed invention (claims 1, 3-7, and 21-24 to a testing system, claims 8-14 to a computer implemented system, and claims 15-20 to a non-transitory computer program product are directed to statutory subject matter.
Regarding claims 1, and 3-24, the claims are directed to systems for assessment of antibody concentration, therefore the answer is "yes".
With respect to step (2A)(1), the claims recite abstract ideas. To determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon, MPEP at 2106.03 teaches abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships, and mathematical calculations), certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, evaluating, and organizing information (see MPEP 2106.04(a)(2)). In the instant application, the claims recite the following limitations that equate to an abstract idea with mental processes.
With respect to the instant claims, under the step (2A)(1) evaluation, the claims are found herein to recite abstract ideas that fall into the grouping of mental processes (in particular processes for analyzing and organizing stored LFA test data for antibody concentration determinations). The claim limitations (emphasis added) directing to abstract ideas are as follows (full claims listed below):
Mental processes:
Claims 4, 11, 13, and 18: to analyze a plurality of stored test result collection instances associated with the patient identifier…
From claim 4: The testing system of claim 3, wherein the processor is further operable to analyze a plurality of stored test result collection instances associated with the patient identifier to provide an output including a representation of intensity data value over time.
From claim 11: The system of claim 10, further comprising: a processor to analyze a plurality of stored test result collection instances associated with the patient identifier and output a representation of intensity data value over time.
Claim 13: The system of claim 10, further comprising: a processor to analyze a plurality of stored test result collection instances across a plurality of users.
From claim 18: The computer program product of claim 17, further comprising instructions that when executed cause the processor to analyze a plurality of stored test result collection instances associated with the patient identifier and provide an output including a representation of intensity data value over time.
Claims 5, 12, and 19: the output is a graph of antibody concentration based on the collected intensity data values over time.
From claim 5: The testing system of claim 4, wherein the output is a graph of antibody concentration based on the collected intensity data values over time.
From claim 12: The system of claim 11, wherein the output is a graph of intensity data value over time, correlated to an antibody concentration over time.
From claim 19: The computer program product of claim 18, wherein the output is a graph of intensity data value over time, correlated to an antibody concentration over time.
Claims 6 and 20: correlating a plurality of stored test result collection instances across a plurality of users over time.
From claim 6: The testing system of claim 1, further comprising: correlating a plurality of stored test result collection instances across a plurality of users over time.
From claim 20: The computer program product of claim 15, the program instructions executable by a processor further to cause the processor to correlate a plurality of stored test result collection instances across a plurality of users over time.
Claim 8: when the test device determines that a local memory does not include a specific test configuration profile associated with a cassette including a lateral flow assay (LFA) being used with the test device;
From claim 8: A computer implemented system for testing, comprising: a communications interface to receive a request from a test device for at least one of a plurality of test configuration profiles, when the test device determines that a local memory does not include a specific test configuration profile associated with a cassette including a lateral flow assay (LFA) being used with the test device; a processor configured to send the requested test configuration profile to the test device; the communications interface further to receive a test result collection instance from the test device; and a memory to store the test result collection instance in a central patient database.
Hence, the claims explicitly recite elements that, individually and in combination, constitute abstract ideas (Further, the claims respective supporting limitations are analyzed as additional elements in subsequent step (2A)(2)).
With respect to step (2A), under the broadest reasonable interpretation (BRI), the instant claims recite mental steps for assessment of antibody concentration with LFA analysis.
Instant claims recite mental processes as to these methodology steps of analyzing…correlating…determining…). Under the BRI, one with ordinary skill in the art could be performed said steps simply by mentally analyzing test results (from laboratory LFA studies) and utilized according to patient, user, and device parameters to assess antibody concentration over time (see MPEP § 2106.04(a)(2), subsection III). The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation (see, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper")).
Because the claims do recite judicial exceptions, direction under step (2A)(2) provides that the claims must be examined further to determine whether they integrate the abstract ideas into a practical application (MPEP 2106.04(d). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exception, the claim is said to fail to integrate into a practical application (MPEP 2106.04(d).III).
With respect to the instant recitations, the claims recite the following exemplary additional elements considered for practical application:
Claims 1, 8, 15 : test device, configuration of a cassette, lateral flow assay ("LFA") strip including a test line and a color and a threshold intensity value for the test line that indicates a positive result, brightness setting for a positive result; a memory
Claims 1, 8, 11-13, 15, and 17-20: a processor (claims 8, 13, and 20), memory coupled to the processor, a first communications interface, in the central patient database, a test device, computer-implemented/system (claims 8, 11-13), computer program product/ a non-transitory computer readable storage medium (claims 18-20, FIGs 10 and 11).
Claims 1 and 15: storing a central testing database…test configuration profiles and a central patient database… including identification of area …receiving a request from a test device the requested test configuration profile used to read and interpret an LFA strip…sending the requested test configuration profile to the test device…receiving a test result collection instance from the test device, wherein the processor is configured to store the test result collection instance.
Claims 3, 10, and 17: a collected intensity data value and a patient identifier.
Claims 5, 12, and 19: the output is a graph of antibody
Claim 14: includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
Claim 8: to receive a request from a test device for at least one of a plurality of test configuration profiles…to receive a test result collection instance from the test device; …to store the test result collection instance…
Claims 1, 9, and 15: threshold value for a positive test result.
Claim 14: includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
Claim 15: a computer program product for testing, the computer program product comprising a non-transitory computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to: store a plurality of test configuration profiles in a central testing database; receive a request from a test device for at least one of the plurality of test configuration profiles, each test configuration profile associated with a particular cassette configuration holding a lateral flow assay (LFA) strip and brightness setting for a positive result; send the requested test configuration profile to the test device; receive a test result collection instance from the test device; and store the test result collection instance in a central patient database.
Said steps that are “in addition” to the recited judicial exception in the instant claims represent those of mere data handling (data movement, e.g. store/receive/send, provide/collected from/to a test device/central database a request/collection instance/test configuration profile/output; data characterization, e.g. data source LFA/image of the LFA strip, a graph of antibody concentration), “apply it” instructions or field of use limitations for test information (profile further includes intensity for a control line; test result labelling, e.g. control, a positive test, a negative test, and an invalid test; data output format as a graph) to implement the recited judicial exception in a generic computer environment. These steps are insignificant extra-solution activity and are insufficient to integrate an abstract idea into a practical application (MPEP 2106.05(g).
Further steps herein directed to additional non-abstract elements of computer-implemented/system, computer program product/ a computer readable storage medium, processor; test device, configuration of a cassette, central database… do not describe any specific computational steps by which the “computer parts” perform or carry out the abstract idea, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the abstract idea. Hence, these are mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(f)).
As such, the claims are lastly evaluated using the step (2B) analysis, wherein it is determined that because the claims recite abstract ideas which do not integrate the abstract ideas into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide the inventive concept or the practical application and that the identification of whether the additional elements amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements of data gathering, instructions, and field of use limitations described above do not rise to the level of significantly more than the judicial exception. As directed in the Berkheimer memorandum of 19 April 2018 and set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant recitations, the claims recite the following exemplary additional elements considered for inventive concepts:
Claims 1, 8, 15 : test device, configuration of a cassette, lateral flow assay ("LFA") strip including a test line and a color and a threshold intensity value for the test line that indicates a positive result, brightness setting for a positive result; a memory
Claims 1, 8, 11-13, 15, and 17-20: a processor (claims 8, 13, and 20), memory coupled to the processor, a first communications interface, in the central patient database, a test device, computer-implemented/system (claims 8, 11-13), computer program product/ a non-transitory computer readable storage medium (claims 18-20, FIGs 10 and 11).
Claims 1 and 15: storing a central testing database…test configuration profiles and a central patient database… including identification of area …receiving a request from a test device the requested test configuration profile used to read and interpret an LFA strip…sending the requested test configuration profile to the test device…receiving a test result collection instance from the test device, wherein the processor is configured to store the test result collection instance.
Claims 3, 10, and 17: a collected intensity data value and a patient identifier.
Claims 5, 12, and 19: the output is a graph of antibody
Claim 14: includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
Claim 8: to receive a request from a test device for at least one of a plurality of test configuration profiles…to receive a test result collection instance from the test device; …to store the test result collection instance…
Claims 1, 9, and 15: threshold value for a positive test result.
Claim 14: includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
Claim 15: holding a lateral flow assay (LFA) strip and brightness setting for a positive result; send the requested test configuration profile to the test device; receive a test result collection instance from the test device; and store the test result collection instance in a central patient database.
These additional elements do not contribute significantly more to well-known and conventional laboratory test analysis, which are routinely determined and performed by an one with ordinary skill in the art as of the effective filing date.
Urusov [Urusov AE et al. (2019) Towards Lateral Flow Quantitative Assays: Detection Approaches. Biosensors, 9(3), 16 pgs.; https://doi.org/10.3390/bios9030089] teaches POC testing with lateral flow assay and to quantify antibody analytes with stored image registration of colorimetric labels and analysis results as positive/negative. Instrumental detection can register staining intensity that can be compared to the values stored in the device’s memory and staining intensity compared to the negative (zero) sample, conveyed with cloud interfaces [p2-3, FIGs 2 and 5].
Rutter [US Pub 2010/0267049; PTO 892 cited, herein Rutter] teaches devices, systems, and methods for detecting the presence of antibody analyte(s) in a sample with lateral flow test strips and a control analyte to normalize the detection of the target analyte [0010].
Huo et al. (2017: Smartphone-Based Dual-Modality Imaging System for Quantitative Detection of Color or Fluorescent Lateral Flow Immunochromatographic Strips Nanoscale Research Letters 12:291 DOI 10.1186/s11671-017-2078-9; 10/22/2025 IDS cited; herein Hou) teaches a smartphone-based dual-modality imaging system was developed, which could quantitatively detect color or fluorescent lateral flow immunochromatographic strip (ICTS). In this system, the white and UV light of an optical system was designed and could be changed according to the different kinds of strips (color strip or fluorescence strip).
Data (e.g. test results and parameters from generic computer of a test device) remain merely analyzed and manipulated as input/output in the judicial exception. With respect to the instant claims, the steps and additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception.
Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 4-6, 8, 11-13, and 18-20 are not patent eligible.
Response to 101 Remarks
The Applicant's remarks (p.7-13), filed 09/09/2025, have been fully considered. The Applicant asserts:
[Remarks, p.7] “The rejection in this case simplified and paraphrased the claim limitations, and does not address them as recited…The rejection should address the language of the claims, as set forth, rather than a summary excluding many of the specific limitations. Therefore, for the above reasons, the rejection is not sufficiently clear and specific to provide Applicant notice of the reasons for ineligibility and enable Applicant to effectively respond…”
[Remarks, p.8] “Here, the claims do not fall within the mental processes grouping because they contain limitations that cannot practically be performed in the human mind, including, for example, "provide an output including a representation of intensity data value over time, "a processor configured to send the requested test configuration profile to the test device, the communications interface further to receive a test result collection instance from the test device; and a memory to store the test result collection instance in a central patient database…”
[Remarks p6] “Here, the claims at issue recite such limitations, including a testing system for LFA tests which are capable of being used with a variety of LFA configurations. This is an improvement over the prior customized testing systems, which were for a particular LFA type. In contrast, because of the ability to integrate a variety of test configuration profiles, the present system is able to use a variety of testing cassettes (See Specification paragraph 42) and a variety of disease types (Specification, paragraph 43)… Here, the claims at issue do not merely add insignificant extra-solution activity to the Examiner's alleged abstract concept. Rather, these features are integral to the system, and create an improved tester system and testing environment.”.
However, it is respectfully submitted that Applicant’s assertion is not persuasive.
Regarding A., the claims have all been examined to identify the presence of one or more judicial exceptions. Claims are directly quoted (pages 4-6 and 8) in the previous office action (emphasis added) and highlight limitations directed to the identified judicial exception (abstract idea-mental processes). Examples of additional elements which are field of use limitations include brightness settings for lighting the LFA strip to take an image for analysis, intensity for a control line to validate the LFA strip, an image of the LFA strip, and a test device results that are one of: a positive test, a negative test, and an invalid test. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application in step 2(A)(2), detailed on pages 6-7. Additional elements (emphasis added) are directly quoted from the claims on pages 6-9 and found to be limitations reciting data gathering, instructions, and field of use limitations as described above, and thereby when considered individually or as an ordered combination, were unable to provide practical integration.
Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions, in step 2(B) detailed on pages 8-9. In combination, the data gathering steps providing the information required to be acted upon by the JE, which is performed in a generic computer or generic computing environment fail to rise to the level of significantly more than that JE. The data gathering steps provide the data for the JE, which is carried out by the general-purpose computers. No non-routine step or element has clearly been identified. Further, these limitations recite data gathering limitations using well understood, recognized, and conventional techniques (i.e. field of use limitations discussed above: lighting brightness settings, image analysis of LFA strips, and use of a control line, positive/negative/invalid labels in the field of LFA testing as taught by Urusov, Rutter, and Hou as described above, and thereby when considered individually or as an ordered combination, were unable to provide an inventive concept.
Regarding B. claims reciting mental steps, with or without a computer, “the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of binary- coded decimal numerals to pure binary numerals can be done mentally,” i.e., "as a person would do it by head and hand").” As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681,1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307,1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. FirstChoice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping” was an abstract idea because it could be "performed by humans without a computer").” (see also MPEP 2106.04 “Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer). Furthermore, the MPEP 2106.05(a) teaches applying the judicial exception with generic computer elements to perform or automate an existing process, and constitute insignificant extra-solution activity, as recited: “Mere automation of manual processes, such as using a generic computer to process an application for financing a purchase, Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017) or speeding up a loan-application process by enabling borrowers to avoid physically going to or calling each lender and filling out a loan application, LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential).”
In contrast to Applicant’s assertions, claims reciting the step “to analyze”, direct to a mental process (Office action p4), in order to “provide an output” of data. The limitation “provide an output” is an element in addition of the general-purpose computer elements (p6 and p9) and not a mental process. Claims recite “the processor… test device… the communications interface… a memory… central patient database”, which are each conventional additional elements (p6 and p9) of a general-purpose computer and routinely function to send…to receive…to store…” data for use in the judicial exception, and are not mental processes themselves. The claimed analyze steps can be performed in the human mind, whether in a generic computing environment, or using the computer as a tool.
Regarding C., the pending claims do not recite a plurality of different types of cartridges/cassettes with different programming profiles needed for each cartridge/cassette type as the basis for an improvement to technology, as asserted by Applicant. All the necessary limitations and sufficient steps required to achieve the asserted improvement are not clearly present in the pending claims.
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.
Claims 1 and 3-24 are rejected under 35 U.S.C. 103 as being unpatentable over Rutter [Rutter (US Pub 2010/0267049); previously cited], in further in view of Hou et al.(2017: Smartphone-Based Dual-Modality Imaging System for Quantitative Detection of Color or Fluorescent Lateral Flow Immunochromatographic Strips Nanoscale Research Letters 12:291 DOI 10.1186/s11671-017-2078-9; 10/22/2025 IDS cited; herein Hou).
Regarding instant claim 1:
A testing system, comprising: a processor; memory coupled to the processor for storing a central testing database having a plurality of test configuration profiles and a central patient database, each test configuration profile associated a configuration of a cassette, including identification of area of a lateral flow assay ("LFA") strip including a test line and a color and a threshold intensity value for the test line that indicates a positive result; and a first communications interface coupled to the processor for:
receiving a request from a test device for at least one of the plurality of test configuration profiles and sending the requested test configuration profile to the test device, the requested test configuration profile used to read and interpret an LFA strip; and
receiving a test result collection instance from the test device, wherein the processor is configured to store the test result collection instance in the central patient database.
The prior art to Rutter teaches that:
POC diagnostic system (a testing device) comprising a system (100, 120) comprises an optical module (130) that, in turn, comprises an excitation module (134) and a detection module (136) with a stage or movable tray (138) to position sample cartridge (141, a cassette) with respect to optical module (130). The resulting light (e.g., of fluorescence) may then be detected by detection module (136), which may provide an indication to an operator that one or more analytes are present in the sample on the test strip (intensity values). The results may be further analyzed to determine the concentration of at least one of the analytes in the sample. An embedded computing device (142) may perform one or more analyses on the light detected by detection module (136) to provide qualitative and/or quantitative analyte data to the operator [0098-0100, FIG. 1A-1C].
a system with a communications interface for communicating with a central test database; and the processor is further configured to determine that the visual feature is not associated with any of the plurality of test configuration profiles in the local testing database; and the processor is further configured to download from the central test database a test configuration profile for storage in the local testing database ([0020: in variations in which the second analyte comprises the control analyte, measuring the concentration of the first analyte in the sample may comprise using a processor, memory resources, and software to evaluate the amount of the first analyte capture agent that is bound to the first analyte relative to the amount of the second analyte capture agent that is bound to the second analyte. The processor, memory resources, and software may analyze the test strip in a period of less than twenty minutes (e.g., less than ten minutes) after the sample has been applied to the portion of the test strip [0010: e.g., a lateral flow test strip comprising a substrate and a coating (e.g., in the form of a band]). The processor as taught by Rutter would be capable of associating the LFA test result and the LFA strip image with a patient identifier and upload to a central patient database and determine a test configuration profile. Cartridge (230, a cassette) may also comprise at least one identification feature (235), such as a barcode or a radio frequency identification device (RFID). Identification feature (235) may store information that can be scanned and/or decoded by a diagnostic system [0109]. Rutter teaches the communications interface includes at least one of a mobile data interface, an Ethernet interface, and a WiFi interface [0245].
While fluorophores have been described as detection agents, some variations of test strips may use other types of detection agents and methods. For example, additional detection methods based on absorption, reflectance, luminescence (e.g., chemiluminescence), or electrical applications may be employed. In certain variations, detection may be indicated by a change in color (or, in some cases, a lack of change in color) (intensity value for the test line that indicates a positive result) in one or more zones of a test strip or other testing substrate or medium. In some variations, detection may be indicated by a change in pH, where the detector function as a pH color indicator [0122].
Data measurements from the excitation, detection, and other modules in the master and/or slave devices may be processed by software system (1700) and stored in the hard drive. Software system (1700) may process and analyze the data as described below, and may generate a report of the test results to the practitioner. The report may comprise information such as patient identification, date, test strip expiration date, lot number, test start and/or finish time, incubation time, incubation temperature, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity, notes from the patient and/or practitioner, interpretation of the results (e.g., positive, negative, indeterminate) [0262].
The data collected by the light sensor boards may be qualitatively and/or quantitatively analyzed in several ways. One analysis may comprise computing the ratio of target analyte fluorescent intensity over the control analyte fluorescent intensity to obtain a relative intensity (RI) value. The RI value may be directly reported as a result... The RI value may also be compared to a cut-off constant [threshold intensity value] provided by the assay table encoded in the barcode. An RI value less than or greater than the cut off constant may be reported to the practitioner as “Negative,” “Positive,” or “Indeterminate” [0274].
However, Rutter does not further disclose receiving a request from a test device for at least one of the plurality of test configuration profiles and sending the requested test configuration profile to the test device, the requested test configuration profile used to read and interpret an LFA strip.
The prior art to Huo teaches a smartphone-based (communications interface) dual-modality imaging system (plurality of test configuration profiles) was developed, which could quantitatively detect color or fluorescent lateral flow immunochromatographic strip (ICTS). In this system, the white and UV light of an optical system (plurality of test configuration profiles) was designed and could be changed (sending the requested test configuration profile to the test device) according to the different kinds of strips (color strip or fluorescence strip) [p3 Col 1] the requested test configuration profile used to read and interpret an LFA strip).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to combine the teachings of Rutter’s LFA intensity analysis system with large test configuration profile database and Huo’s smartphone-based dual modality system capable of working with a plurality of test types with associated cloud test configuration profiles, and motivating one with ordinary skill in the art to move away from relying on test results obtained only from bulky, laboratory based LFA machines and towards data from small LFA readers. Combining these prior art elements would have been obvious because utilizing LFA test results from smaller, mobile readers allows results to be obtained from personalized care and home applications [Huo, p2 Col 1]. One of ordinary skill in the art would predict combining Rutter and Huo, with a reasonable expectation of success as each is analogously applicable to LFA testing and analysis technology. The invention is therefore prima facie obvious.
Regarding instant claims 3, 10, and 17:
wherein the test result collection instance includes a collected intensity data value and a patient identifier.
The prior art to Rutter teaches data measurements from the excitation, detection, and other modules process, analyze, generate a report of the test results to the practitioner (test result collection instance). The report may comprise information such as patient identification, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity, notes from the patient and/or practitioner, interpretation of the results (e.g., positive, negative, indeterminate) [0262]. The data collected by the light sensor boards (test result collection instance) may be qualitatively and/or quantitatively analyzed in several ways. One analysis may comprise computing the ratio of target analyte fluorescent intensity over the control analyte fluorescent intensity to obtain a relative intensity (RI) value. The RI value may be directly reported as a result... The RI value may also be compared to a cut-off constant [threshold intensity value] provided by the assay table encoded in the barcode. An RI value less than or greater than the cut off constant may be reported to the practitioner as “Negative,” “Positive,” or “Indeterminate” [0274].
Regarding instant claims 4, 11, and 18:
to analyze a plurality of stored test result collection instances associated with the patient identifier to provide an output including a representation of intensity data value over time.
The prior art to Rutter teaches data measurements from the excitation, detection, and other modules process, analyze, generate a report of the test results to the practitioner (test result collection instance). The report may comprise information such as patient identification, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity, notes from the patient and/or practitioner, interpretation of the results (e.g., positive, negative, indeterminate) [0262].
Regarding instant claim 5:
the output is a graph of antibody concentration based on the collected intensity data values over time.
The prior art to Rutter recites quantitative analysis of cells and analytes in bodily fluid samples, involves assays that take advantage of the high specificity of antigen-antibody reactions. More specifically, an antigen or antibody may be detected in a sample (and, in some cases, may be quantitatively measured) based on binding between the antigen and an antibody on the assay [0003] (antibody concentration). Target analyte binding agents of a contact band include antibodies, antigens, an antibody binding region, complementarity determining regions (CDR), single chain antibody, chimeric antibody, or humanized antibody, monoclonal antibody or a polyclonal antibody [0119]. The assay is carried out under predefined assay conditions (20 minutes at 33° C.). At the end of this time, sample assay results, intensity of reflectance from each test by a computer interface, are plotted as standard curves of relative intensity for concentration determination [0294] (the output is a graph of antibody concentration).
Regarding instant claims 6 and 20:
correlat[ing] a plurality of stored test result collection instances across a plurality of users over time.
As applied to claim 1, the prior art to Rutter teaches the detection bands may be formed of coatings exhibiting variability relative to each other (e.g., as a result of being coated at different times and/or in different locations on the test strip). Such variability may in turn affect the resulting measurement of the concentration of the target analyte or analytes in the fluid sample. In view of the ongoing need to accurately test for certain analytes additional assays and related devices and methods can be performed for accomplishing such testing with high accuracy [0006]. Point of care testing (POC) systems allow real time results and incorporated into a medical record of the subject (central patient database). A system may be configured for connection to a network for health IT management to transmit the original validated data to any desired location for further analysis, and/or for integration into larger data sets (e.g., for disease management and control) [claim 58: stored test result collection instances across a plurality of users over time. The system may be connected to a personal health management system (central patient database) which may accommodate real-time data capture from any electronic home monitoring and/or POC device, and store the data capture as a secure, interactive and shareable record for individuals, health professionals, payers and other healthcare companies [0277] (stored test result collection instances across a plurality of users over time). For example, FIG. 16A depicts one variation of a diagnostic system (1650) comprising a plurality of cartridges (1602) that retain test strips (not shown) and a plurality of readers (1601). As shown in FIG. 16A [0247], readers (1601) are connected to each other in a daisy-chain formation, via an electrical interface (1603), with the final reader connected to a controller computer (1600). This daisy-chain configuration of multiple readers (1601), with each reader configured to scan the test result of one cartridge (1602), may allow for simple scalability and high throughput.
Regarding instant claims 7 and 14:
wherein the test result collection instance further includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
The prior art to Rutter teaches a POC diagnostic system (2601) may comprise one or more electrical components or interfaces to provide power and data storage capabilities to an optical module. E mission and/or image data collected by a photodiode of a light sensor board may be transmitted to mainframe board (2600) via a light sensor board connector, and the mainframe board may transmit the data to embedded computing device. Display connector (2614) may allow data analyses and images to be presented to a monitor or display [0211, 0213]. Software system (1700) may process and analyze the data as described below, and may generate a report of the test results to the practitioner. The report may comprise information such as patient identification, date, test strip expiration date, lot number, test start and/or finish time, incubation time, incubation temperature, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity, notes from the patient and/or practitioner, interpretation of the results (e.g., positive, negative, indeterminate), etc [0262].
Regarding instant claim 8:
computer implemented system for testing, comprising: a communications interface
to receive a request from a test device for at least one of a plurality of test configuration profiles, when the test device determines that a local memory does not include a specific test configuration profile associated with a cassette including a lateral flow assay (LFA) being used with the test device;
a processor configured to send the requested test configuration profile to the test device;
the communications interface further to receive a test result collection instance from the test device; and
a memory to store the test result collection instance in a central patient database..
The prior art to Rutter teaches that:
POC diagnostic system (a testing device) comprising a system (100, 120) comprises an optical module (130) that, in turn, comprises an excitation module (134) and a detection module (136). System (120) also comprises a stage or movable tray (138), which may be used to position sample cartridge (141, a cassette) with respect to optical module (130). The resulting light (e.g., of fluorescence) may then be detected by detection module (136), which may provide an indication to an operator that one or more analytes are present in the sample on the test strip. In some cases, the results may be further analyzed to determine the concentration of at least one of the analytes in the sample (intensity values). In certain variations, system (120) may comprise an embedded computing device (142) that may perform one or more analyses on the light detected by detection module (136) to provide qualitative and/or quantitative analyte data to the operator [0098-0100, FIG. 1A-1C] (to receive a request from a test device for at least one of a plurality of test configuration profiles].
Another configuration of a diagnostic system (1670) is depicted in FIG. 16C. As shown there, multiple cartridges, an incubator, and a reader may be combined into one module (1606). Interface (1607) with computer (1600) may comprise multiple reader channels that allow for high throughput processing of cartridges. When a tray has a particular configuration, one or more other components of the system may be rearranged or varied to accommodate that configuration. As an example, FIG. 16D shows an excitation module (1610) configured to apply excitatory beams to two separate cartridges (1612) and (1614). Laser beam (1616) is a combination of beams from lasers (1617) and (1618), but is split into two beams that are ultimately directed toward separate cartridges (1612) and (1614). Each cartridge has its own detector module (1622) and (1624), which may or may not be identical to each other. Excitation module (1610) has a configuration that may allow for relatively high throughput testing and analysis of cartridges. The optics of excitation module (1610) may be arranged in any configuration suitable to match the configuration of cartridges (1612) and (1614) for effective application of excitatory beams [0249-0250] (when the test device determines that a local memory does not include a specific test configuration profile associated with a cassette including a lateral flow assay (LFA) being used with the test device; a processor configured to send the requested test configuration profile to the test device].
a system with a communications interface for communicating with a central test database; and the processor is further configured to determine that the visual feature is not associated with any of the plurality of test configuration profiles in the local testing database; and the processor is further configured to download from the central test database a test configuration profile for storage in the local testing database ([0020: in variations in which the second analyte comprises the control analyte, measuring the concentration of the first analyte in the sample may comprise using a processor, memory resources, and software to evaluate the amount of the first analyte capture agent that is bound to the first analyte relative to the amount of the second analyte capture agent that is bound to the second analyte. The processor, memory resources, and software may analyze the test strip in a period of less than twenty minutes (e.g., less than ten minutes) after the sample has been applied to the portion of the test strip [0010: e.g., a lateral flow test strip comprising a substrate and a coating (e.g., in the form of a band]). The processor as taught by Rutter would be capable of associating the LFA test result and the LFA strip image with a patient identifier and upload to a central patient database and determine a test configuration profile. Cartridge (230, a cassette) may also comprise at least one identification feature (235), such as a barcode or a radio frequency identification device (RFID). Identification feature (235) may store information that can be scanned and/or decoded by a diagnostic system [0109]. Rutter teaches the communications interface includes at least one of a mobile data interface, an Ethernet interface, and a WiFi interface [0245].
Variations of test strips may use other types of detection agents and methods based on absorption, reflectance, luminescence (e.g., chemiluminescence), or electrical applications may be employed. Detection may be indicated by a change in color (or, a lack of change in color) (intensity value for the test line that indicates a positive result) in one or more zones of a test strip or other testing substrate or medium. Also, detection may be indicated by a change in pH, where the detector function as a pH color indicator [0122].
Data measurements from the excitation, detection, and other modules may be processed by software system (1700) and stored in the hard drive. Software system (1700) may process and analyze the data to generate a report of the test results to the practitioner. The report may comprise information such as patient identification, date, test strip expiration date, lot number, test start and/or finish time, incubation time, incubation temperature, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity, notes from the patient and/or practitioner, interpretation of the results (e.g., positive, negative, indeterminate) [0262].
The data collected by the light sensor boards may be qualitatively and/or quantitatively analyzed in several ways. One analysis may comprise computing the ratio of target analyte fluorescent intensity over the control analyte fluorescent intensity to obtain a relative intensity (RI) value. The RI value may be directly reported and compared to a cut-off constant [threshold intensity value] provided by the assay table encoded in the barcode. An RI value less than or greater than the cut off constant may be reported to the practitioner as “Negative,” “Positive,” or “Indeterminate” [0274].
Regarding instant claim 9:
wherein the test configuration profile includes a threshold value for a positive test result for the cassette.
The prior art to Rutter teaches data analysis may comprise computing the ratio of target analyte fluorescent intensity over the control analyte fluorescent intensity to obtain a relative intensity (RI) value. The RI value may be directly reported as a result... The RI value may also be compared to a cut-off constant [threshold intensity value] provided by the assay table encoded in the barcode. An RI value less than or greater than the cut off constant may be reported to the practitioner as “Negative,” “Positive,” or “Indeterminate” [0274].
Regarding instant claim 12 and 19:
the output is a graph of intensity data value over time correlated to an antibody concentration over time.
The prior art to Rutter recites quantitative analysis of cells and analytes in bodily fluid samples, involves assays that take advantage of the high specificity of antigen-antibody reactions. An antigen or antibody may be detected and quantitatively measured (antibody concentration) based on binding between the antigen and an antibody on the assay [0003]. Target analyte binding agents of a contact band include antibodies, antigens, an antibody binding region, complementarity determining regions (CDR), single chain antibody, chimeric antibody, or humanized antibody, monoclonal antibody or a polyclonal antibody [0119]. The assay is carried out under predefined assay conditions (20 minutes at 33° C). At the end of this time, sample assay results, intensity of reflectance from each test by a computer interface, are plotted as standard curves of relative intensity for concentration determination [0294] (the output is a graph of antibody concentration).
Regarding instant claim 13:
a processor to analyze a plurality of stored test result collection instances across a plurality of users.
The prior art to Rutter teaches point of care testing (POC) systems allow real time results and incorporated into a medical record of the subject (central patient database). A system may be configured for connection to a network for health IT management. Internet or intranet connectivity may be used, for example, to transmit the original validated data to any desired location for further analysis, and/or for integration into larger data sets (e.g., for disease management and control) [claim 58: stored test result collection instances across a plurality of users over time]. The interface protocols between the local POC system and a remote analysis system may include features that ensure data security and the protection of analysis tool trade secrets. The system may be connected to a personal health management system (central patient database) which may accommodate real-time data capture from any electronic home monitoring and/or POC device, and store the data capture as a secure, interactive and shareable record for individuals, health professionals, payers and other healthcare companies [0277]. As shown in FIG. 16A [0247], readers (1601) are connected to each other in a daisy-chain formation, via an electrical interface (1603), with the final reader connected to a controller computer (1600). This daisy-chain configuration of multiple readers (1601), with each reader configured to scan the test result of one cartridge (1602), may allow for simple scalability and high throughput.
Regarding instant claim 15:
A computer program product for testing, the computer program product comprising a non-transitory computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to:
store a plurality of test configuration profiles in a central testing database;
receive a request from a test device for at least one of the plurality of test configuration profiles, each test configuration profile associated with a particular cassette configuration holding a lateral flow assay (LFA) strip and brightness setting for a positive result;
send the requested test configuration profile to the test device;
receive a test result collection instance from the test device; and
store the test result collection instance in a central patient database.
The prior art to Rutter teaches that:
a system with a communications interface for communicating with a central test database; and the processor is further configured to determine that the visual feature is not associated with any of the plurality of test configuration profiles in the local testing database; and the processor is further configured to download from the central test database a test configuration profile for storage in the local testing database ([0020: in variations in which the second analyte comprises the control analyte, measuring the concentration of the first analyte in the sample may comprise using a processor, memory resources, and software to evaluate the amount of the first analyte capture agent that is bound to the first analyte relative to the amount of the second analyte capture agent that is bound to the second analyte. The processor, memory resources, and software may analyze the test strip in a period of less than twenty minutes (e.g., less than ten minutes) after the sample has been applied to the portion of the test strip [0010: e.g., a lateral flow test strip comprising a substrate and a coating (e.g., in the form of a band]). The processor as taught by Rutter would be capable of send the requested test configuration profile to the test device; receive a test result collection instance from the test device; and store the test result collection instance in a central patient database, and determine whether a visual feature is not associated with a test configuration profile. Cartridge (230, a cassette) may also comprise at least one identification feature (235) (a particular cassette configuration holding a lateral flow assay (LFA) strip) such as a barcode or a radio frequency identification device (RFID). Identification feature (235) may store information that can be scanned and/or decoded by a diagnostic system during use [0109].
During use, laser beams from excitation module (134) may illuminate a portion of the test strip that is located in sample cartridge (141). The resulting light (e.g., of fluorescence) may then be detected by detection module (136), which may provide an indication to an operator that one or more analytes are present in the sample on the test strip and analyzed to determine the concentration of at least one of the analytes in the sample (particular cassette configuration holding a lateral flow assay (LFA) strip and brightness setting for a positive result). An embedded computing device (142) may perform one or more analyses on the light detected by detection module (136) to provide qualitative and/or quantitative analyte data to the operator [0099]. While fluorophores have been described as detection agents, some variations of test strips may use other types of detection agents and methods based on absorption, reflectance, luminescence (e.g., chemiluminescence), or electrical applications may be employed. Detection may be indicated by a change in color (or, in some cases, a lack of change in color) (intensity value for the test line that indicates a positive result) in one or more zones of a test strip or other testing substrate or medium; or by a change in pH, where the detector function as a pH color indicator [0122].
Regarding instant claim 16:
wherein the test configuration profile includes a configuration of the cassette, including identification of area of a lateral flow assay ("LFA") strip including a test line, and a color and a threshold intensity value for a positive test result.
The prior art to Rutter teaches data collected by the light sensor boards may be qualitatively and/or quantitatively analyzed by computing the ratio of target analyte fluorescent intensity over the control analyte fluorescent intensity to obtain a relative intensity (RI) value. The RI value may be directly reported as a result. The RI value may also be compared to a cut-off constant [threshold intensity value] provided by the assay table encoded in the barcode. An RI value less than or greater than the cut off constant may be reported to the practitioner as “Negative,” “Positive,” or “Indeterminate” [0274].
Regarding instant claim 21:
profile further includes brightness settings for lighting the LFA strip to take an image for analysis.
The prior art to Rutter teaches data measurements from the excitation, detection, and other modules in the master and/or slave devices may be processed by software system (1700) and stored in the hard drive. Software system (1700) may process and analyze the data, and generate a report of the test results to the practitioner. The report may comprise information such as patient identification, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity [0262].
Regarding instant claim 22:
profile further includes intensity for a control line, the control line used to validate the LFA strip.
The prior art to Rutter teaches the system determines the intensity of reflectance (IR) from each test and control band (the control line used to validate the LFA strip ) and the results can then be accessed using the computer interfaced with the instrument [0294]. LFA test strips may further comprise an analyte binding agent and a control analyte (e.g., in a different band from the first and second analyte capture agents). The analyte binding agent may be labeled with a first fluorophore that fluoresces upon exposure to light from the first light source. The control analyte may be labeled with a second fluorophore that fluoresces upon exposure to light from the second light source. Measuring the concentration of the first analyte in the sample may comprise comparing the intensity of the fluorescence of the first fluorophore to the intensity of the fluorescence of the second fluorophore [0020] (intensity for a control line, the control line used to validate the LFA strip). Also, a control analyte detector may be employed so that test analyte detection may be normalized with respect to control analyte detection (e.g., to remove manufacturing and environmental variability that may impact test analyte detection precision) [0282].
Regarding instant claim 23:
test result collection instance includes an image of the LFA strip, and a test result determined by the test device.
The prior art to Rutter teaches a software system (1700) may process and generate a report of the test results to the practitioner. The report may comprise information such, analyses performed, relevant calibration and/or standard curves, an image of the scanned strip showing the location of the fluorescent bars, relative intensity, interpretation of the results (e.g., positive, negative, indeterminate), etc [0262].
Regarding instant claim 24:
test result comprises one of: a positive test, a negative test, and an invalid test.
The prior art to Rutter teaches a software system (1700) may process and generate a report of the test results to the practitioner with interpretation of the results (e.g., positive, negative, indeterminate), etc [0262].
Response to 102/103 Remarks
The Applicant’s remarks (p13-16), filed 09/09/2025, have been fully considered but they were not persuasive, as discussed in the above 102/103 rejection. Any newly recited portions or rejections, as set forth above, are necessitated by instant application amendments.
Regarding independent claim 1, and its dependent claims, Applicant’s assertions that “Rutter only describes one particular test configuration, with one particular cassette… no teaching or suggestion of a plurality of test configurations, much less a test system requesting a new test configuration, when it is determined that the test configuration is not present on the device” and “a communications interface to receive a request for a test configuration profile, to enable the testing system to utilize the new configuration profile to read and interpret an LFA strip” in further view of Huo were not persuasive as set forth in above rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Instant claims 1, 7-8, 15, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over reference claims 1-4, 7-8, 10-14, 18, and 20 of Sivertsen C, U.S. Application 17/079,513 (US20240402198A1, "Medical Test Strip Analysis," filed October 25, 2020). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection.
Regarding instant claims 1 and 15 and 24,
reference claims 1-2 and 10-12 (system further comprises a communications interface for communicating with a central patient database and a patient identification reader for reading a patient identifier and the processor associates the LFA test result and the LFA strip image with the patient identifier and uploads the LFA test result and LFA strip image to the central patient database): a processor; memory coupled to the processor for storing a central testing database having a plurality of test configuration profiles and a central patient database, each test configuration profile associated a configuration of a cassette, including identification of area of a lateral flow assay ("LFA") strip including a test line and a color; reference claims 3 and 13 (wherein the indication panel comprises a plurality of indicators for indicating respectively a positive, a negative, or an invalid LFA test result) and a threshold intensity value for the test line that indicates a positive result; reference claims 8 and 18 (wherein the communications interface includes at least one of a mobile data interface, an Ethernet interface, and a WiFi interface) a first communications interface coupled to the processor for: receiving a request from a test device for at least one of the plurality of test configuration profiles and sending the requested test configuration profile to the test device, the requested test configuration profile used to read and interpret an LFA strip; and receiving a test result collection instance from the test device, wherein the processor is configured to store the test result collection instance in the central patient database.
Regarding instant claim 7:
reference claims 4 and 14 (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) wherein the test result collection instance further includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
Regarding instant claims 8:
reference claim 11 (communications interface for communicating with a central test database, wherein the processor downloads from the central test database a test for storage in the local testing database when the visual feature cannot be used to determine a first test of the plurality of tests due to the visual feature not being associated with any tests within the plurality of tests) a communications interface to receive a request from a test device for at least one of a plurality of test configuration profiles, when the test device determines that a local memory does not include a specific test configuration profile associated with a cassette including a lateral flow assay (LFA) being used with the test device.
Regarding instant claim 21-24:
reference claim 20 (receiving, by a processor, test information for a cassette, receiving, by the processor, an image of the cassette; receiving, by the processor, light settings for a plurality of light sources; storing, by the processor, the light settings for the cassette in the configuration profile; and receiving, by the processor, a threshold value for a positive test result for the cassette and storing the threshold value in the configuration profile): brightness settings for lighting the LFA strip, control line used to validate the LFA strip, image of the LFA strip, and a test result determined by the test device, test result comprises one of: a positive test, a negative test, and an invalid test.
B. Instant claims 1, 7-9, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-2, 5, 8, 10- 12, and 20 of Sivertsen C et al. U.S. Patent Application 17/382944 (US20240412829A1, Medical test hub with display, filed July 22, 2021). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection.
Regarding instant claims 1, 9, and 16,
reference claims 1-2 and 10, 12 (a system comprising: a processor; memory coupled to the processor for storing a local testing database having a test configuration profile with the test configuration profile having an intensity threshold value denoting a positive test result; a carrier for receiving a cassette containing a lateral flow assay (“LFA”) strip; a display screen coupled to the processor for displaying LFA test results; and an LFA strip reader coupled to the processor for reading the LFA strip regardless of alignment of the cassette within the carrier and transmitting an LFA strip image to the processor, wherein the processor determines an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value, and further wherein the processor provides the LFA test result on the display screen): a processor; memory coupled to the processor for storing a central testing database having a plurality of test configuration profiles and a central patient database, each test configuration profile associated a configuration of a cassette, including identification of area of a lateral flow assay ("LFA") strip including a test line and a color and a threshold intensity value for the test line that indicates a positive result; and reference claims 8 and 20 (display screen is operable to display the operator input on the display screen): a first communications interface coupled to the processor for: receiving a request from a test device for at least one of the plurality of test configuration profiles and sending the requested test configuration profile to the test device, the requested test configuration profile used to read and interpret an LFA strip; and receiving a test result collection instance from the test device, wherein the processor is configured to store the test result collection instance in the central patient database; reference claim 11 (wherein the test configuration profile includes a threshold value for a positive test result for the cassette).
Regarding instant claim 7:
reference claim 5 (wherein the display screen is further operable to display the LFA strip image): wherein the test result collection instance further includes an image of a test strip and the processor is further operable to provide the image of the test strip to a user upon receiving a request.
Regarding instant claims 8:
reference claim 11 (communications interface for communicating with a central test database, wherein the processor downloads from the central test database a test for storage in the local testing database when the visual feature cannot be used to determine a first test of the plurality of tests due to the visual feature not being associated with any tests within the plurality of tests) a communications interface to receive a request from a test device for at least one of a plurality of test configuration profiles, when the test device determines that a local memory does not include a specific test configuration profile associated with a cassette including a lateral flow assay (LFA) being used with the test device.
Response to DP Remarks
The Applicant's remarks [p.6], filed 09/09/2025, have been fully considered regarding the previous Office Action. They are not persuasive because they do not provide any arguments against the merits of the rejection. The double patent rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting following form via EFS-Web or Central Fax (571-103-8300): PTO/SB/439. Applicant is encouraged to do so as early in prosecution as possible, so as to facilitate communication during examination.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web or Central Fax (571-103-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Inquiries
Papers related to this application may be submitted to Technical Center 1600 by facsimile transmission. Papers should be faxed to Technical Center 1600 via the PTO Fax Center. The faxing of such papers must conform to the notices published in the Official Gazette, 1096 OG 30 (November 15, 1988), 1156 OG 61 (November 16, 1993), and 1157 OG 94 (December 28, 1993) (See 37 CFR § 1.6(d)). The Central Fax Center Number is (571) 273-8300.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vy Rossi, whose telephone number is (703) 756-4649. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached on (571) 272-2249. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public.
VY ROSSI
Examiner
Art Unit 1685
/MARY K ZEMAN/Primary Examiner, Art Unit 1686
Prosecution Insights