DETAILED ACTION
Applicant' s response, filed 03 March 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-4, 6, 7, 9-14, and 21-25 are pending an examined herein.
Claims 1-4, 6, 7, 9-14, and 21-25 are rejected.
Priority
Claims 1-4, 6, 7, 9-14, and 21-25 are granted the claim to the benefit of priority to U.S. Provisional application 62/957527, 62/876263, and 62/869210 filed 06 January 2020, 19 July 2019, and 01 July 2019. Thus, the effective filling date of claims 1-4, 6, 7, 9-14, and 21-25 is 01 July 2019.
Claim Interpretation
Claim 1 recites contingent limitations. The limitation of “outputting a prompt to remove the test strip” at a first time is contingent on the condition of not verifying the test strip being met. The limitations of “measuring an ambient temperature” and “determining, based on at least the ambient temperature or a rate of change in temperature” at a second time are contingent on the condition of verifying the test strip being met. The limitations of “measuring, with the handheld analyzer, a measured concentration of at least one analyte…” and “outputting the measured concentration to a user and/or wirelessly communicating the measured concentration to the computing device” are contingent on the condition of determining that the sample has reached the stable target temperature being met. The MPEP states the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (see MPEP 2111.04(II)). Thus, the BRI of claim 1 only requires the steps of “initiating a wireless connection between a handheld analyzer and a computing device on which…”, “automatically downloading over the wireless connection and storing, on the handheld analyzer, a test strip type data, and batch data…”, and “verifying a test strip inserted into the handheld analyzer based on 1) comparing a type of the test strip to the downloaded test strip type data to… and 2) determining whether the test strip has been used, wherein determining whether the test strip has been used comprises…”. Claims 2, 4, 12, 13, and 21-23 recite limitations which are contingent on the condition of verifying the test strip at a second time and the condition of determining that the sample has reached the stable target temperature being met because the measuring step and measured concentration is contingent on these conditions being met and are not required to be met under the BRI of the claimed method.
Claim 24 recites contingent limitation. The limitation of “outputting a prompt to remove the test strip” at a first time is contingent on the condition of not verifying the test strip being met. The limitations of “measuring, with the handheld analyzer, a measured concentration of at least one analyte…”, “wirelessly communicating the measured concentration from the handheld analyzer to the computing device”, “displaying the measure concentration on the computer device”, “transmitting the measured concentration to a database”, and “organizing data including the measured concentration and at least one additional measured analyte…” at a second time are contingent on the condition of verifying the test strip being met. The MPEP states the broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (see MPEP 2111.04(II)). Thus, the BRI of claim 24 only requires the steps of “initiating a wireless connection between a handheld analyzer and a computing device on which…”, “automatically downloading over the wireless connection and storing, on the handheld analyzer, a test strip type data, and batch data…”, and “verifying a test strip inserted into the handheld analyzer based on 1) comparing a type of the test strip to the downloaded test strip type data to… and 2) determining whether the test strip has been used based on measuring an impedance…”.
Claim Rejections - 35 USC § 112
112/b
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “wherein the data is organized based upon groups of multiple users belonging to multiple organizations”. The indefiniteness arises because the claim does not make clear what “the data” is referring to in amended claim 1 due to amended claim 1 removing the limitation of organizing data which is now recited in amended claim 2. Thus, it is unclear if “the data” is referring to the measured concentration or other data collected in amended claim 1. This rejection could be overcome by amending claim 3 to depend from claim 2 which now recites a step of organizing data. For the sake of furthering examination, claim 3 will be interpreted as depending from claim 2 which recites a step of organizing data.
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 1-4, 6, 7, 9-14, and 21-25 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.
(Step 1)
Claims 1-4, 6-14, and 21-24 fall under the statutory category of a process
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. The instant claims further recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations.
Independent claims 1 recite a mental process of “verifying a test strip inserted into the handheld analyzer based on comparing a type of the test strip to the downloaded test strip type data to determine whether the type of the test strip matches the downloaded test strip type data”, “determining whether the test strip has been used” and “determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature”.
Independent claim 24 recites mental process of “verifying a test strip inserted into the handheld analyzer based on comparing a type of the test strip to the downloaded test strip type data to determine whether the type of the test strip matches the downloaded test strip type data”, “determining whether the test strip has been used”, and “organizing data including the measured concentration and at least one additional measured analyte concentration from at least one additional user”.
Dependent claim 4 recites a mental process of selecting a specific source from which the sample will be taken and confirming the wireless connection between the handheld analyzer and the smart computing device. Dependent claim 6 recites a mental process of comparing the test strip identification with data to determine the test strip type and batch data. Dependent claim 7 further recites a mental process of considering the test strip type and batch data, determining an error if the test strip type is an unknown test strip type. Dependent claim 9 recites a mental process of providing instructions to a user regarding how to collect the sample. Dependent claim 10 recites a mental process of applying a detection technique base on the ambient temperature. Dependent claim 11 further recites a mental process of determining that a measurement is inaccurate and detecting an abnormally high signal or an abnormally low signal for the test strip. Dependent claim 12 further recites a mental process of analyze the measured concentration to assist in user interpretation. Dependent claim 13 further recites a mental process of refer the measured concentration to a threshold. Dependent claim 14 further recites a mental process of analyzing a response to determine that the bodily fluid sample is a valid sample. Dependent claim 21 further recites a mental process and mathematical concept of generate further calculations. Dependent claim 22 recites a mental process of providing at least one recommended action based on the measured concentration.
The claims require a process of verifying a test strip by comparing test strip data, determining if a test strip has been used by analyzing measured data from the test strip, determining whether a sample collected has reached a stable target temperature based on an ambient temperature or rate of change of a temperature, organizing data, and making judgements on measured signals and analyte levels using criteria. The human mind is capable of organizing data, making judgements, analyzing data, making comparisons, evaluating data with or without the aid of pen and paper. Dependent claims 3 and 23 further limit the mental process recited in the claims but do not change their nature as a mental process.
(Step 2A Prong 2)
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional elements in claim 1 and 24 of initiating a wireless connection between a handheld analyzer and a computing device, automatically downloading over the wireless connection and storing, on the handheld analyzer do not integrate the judicial exceptions into a practical application because this is adding insignificant extra solution activity of data gathering because these additional elements only interact with the judicial exceptions by providing data to be processed by judicial exceptions.
The additional elements in claim 1 of measuring an ambient temperature, measuring with the handheld analyzer a measured concentration of at least one analyte in the sample collected on the test strip inserted into the handled analyzer, the measured concentration determined using the batch specific calibration coefficients of the test strip and the measured ambient temperature, outputting the measured concentration to a user and/or wirelessly communicating the measured concentration to the computing device do not integrate the do not integrate the judicial exceptions into a practical application because these steps are not required to be performed by the method due to being contingent on conditions being met.
The additional elements in claim 24 of measuring, with the handheld analyzer, a measured concentration of at least one analyte in a sample collected on the test strip, the measured concentration determined using the batch specific calibration coefficients, wirelessly communicating the measured concentration from the handheld analyzer to the computing device; displaying the measured concentration on the computing device, transmitting the measured concentration to a database do not integrate the do not integrate the judicial exceptions into a practical application because these steps are not required to be performed by the method due to being contingent on conditions being met.
The additional element in claims 1 and 24 of measuring an impedance of the test strip or measuring a current in the test strip with the handheld analyzer does not integrate the judicial exceptions into a practical application because this is insignificant extra solution activity of data gathering because this process only interacts with the judicial exceptions as a way to gather data for the judicial exceptions.
The additional elements in claim 2 of wirelessly communicating the measured concentration from the handheld analyzer to the computing device, displaying the measured concentration on the computing device, transmitting the measured concentration to a database and the additional elements in claim 21 of transferring the measured concentration to another device to at least one or display the measured concentration or store the measured concentration do not integrate the judicial exceptions into a practical application do not integrate the do not integrate the judicial exceptions into a practical application because these steps are not required to be performed by the method due to being contingent on conditions being met.
The additional elements in claim 4 of initiating the measuring step via the computing device, wherein initiating the measuring step comprises: logging into an operator account on the analyte analysis application; selecting a specific source from which the sample will be taken, and confirming the wireless connection between the handheld analyzer and the computing device do not integrate the do not integrate the judicial exceptions into a practical application because these steps are not required to be performed by the method due to being contingent on conditions being met.
The additional element in claim 6 of measuring a resistance-encoded test strip identification on the test strip, the additional element in claim 11 of measuring a signal inconsistency, the additional elements in claim 14 of applying an electrical signal to the test strip and measuring, with the handheld analyzer, a response of a combination of the test strip and the bodily fluid sample to the applied electrical signal do not integrate the judicial exceptions into a practical application because this is adding insignificant extra solution activity of data gathering because these additional elements interact with the judicial exceptions by providing a series of steps that result in collecting data to be processed by judicial exceptions.
The additional element in claim 7 of communication data to the computing device and alerting a user on the handheld analyzer and computing device does not integrate the judicial exceptions into a practical application because this is adding insignificant extra solution activity of data output because these additional elements interact with the judicial exceptions by transmitting/outputting data from the judicial exceptions.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1-4, 6-14, and 21-24 are directed to the abstract idea.
(Step 2B)
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The additional elements in claim 1 of measuring an ambient temperature, measuring with the handheld analyzer a measured concentration of at least one analyte in the sample collected on the test strip inserted into the handled analyzer, the measured concentration determined using the batch specific calibration coefficients of the test strip and the measured ambient temperature, outputting the measured concentration to a user and/or wirelessly communicating the measured concentration to the computing device do not amount to significantly more than the judicial exception because these steps are not required to be performed by the method due to being contingent on conditions being met.
The additional elements in claim 24 of measuring, with the handheld analyzer, a measured concentration of at least one analyte in a sample collected on the test strip, the measured concentration determined using the batch specific calibration coefficients, wirelessly communicating the measured concentration from the handheld analyzer to the computing device; displaying the measured concentration on the computing device, transmitting the measured concentration to a database do not amount to significantly more than the judicial exception because these steps are not required to be performed by the method due to being contingent on conditions being met. The additional elements in claim 1 and 24 of initiating a wireless connection between a handheld analyzer and a computing device, automatically downloading over the wireless connection and storing, on the handheld analyzer is conventional as shown by [0036], [0044], [0063], [073], and [0111] Wang et al. (US 20170226557 A1; previously cited) which shows initiating a wireless connection between a handheld analyzer and a computing device and the handheld analyzer has a transceiver to transmit and receive data, and in [0021] and [0022] of Ackermann et al. (US 20080217407 A1; previously cited) which shows wirelessly downloading data on a handheld analyzer. It is noted that the contents of the data falls under the abstract idea and does not change the active step of a handheld analyzer receiving or transmitting data from a computing system.
The additional element in claims 1 and 24 of determining whether the test strip has been used, wherein determining whether the test strip has been used comprises measuring an impedance of the test strip or measuring a current in the test strip with the handheld analyzer is shown in [0037] and [0038] of Harrison et al. (US 20140027308 A1; newly cited) and in the abstract and [0032] of Allen (US 20050284757 A1; newly cited).
The additional elements in claim 2 of wirelessly communicating the measured concentration from the handheld analyzer to the computing device, displaying the measured concentration on the computing device, transmitting the measured concentration to a database and the additional elements in claim 21 of transferring the measured concentration to another device to at least one or display the measured concentration or store the measured concentration do not amount to significantly more than the judicial exception because these steps are not required to be performed by the method due to being contingent on conditions being met..
The additional elements in claim 4 of initiating the measuring step via the computing device, wherein initiating the measuring step comprises: logging into an operator account on the analyte analysis application; selecting a specific source from which the sample will be taken, and confirming the wireless connection between the handheld analyzer and the computing device do not amount to significantly more than the judicial exception because these steps are not required to be performed by the method due to being contingent on conditions being met.
The additional element in claim 6 of measuring a resistance-encoded test strip identification on the test strip is conventional as shown in [0066] and [0069]-[0070] of Beaty (US 20050279647 A1; previously cited) and [0036] of Hsu (US 20100012490 A1; previously cited). The additional element in claim 7 of communicating data and alerting a user on the handheld analyzer and computing device is shown to be conventional as shown by in [0041] of Ackermann et al. (US 20080217407 A1; previously cited) which shows a message indicating a test strip lot ID does not match any information in the system (i.e. unknown) and in [0058] of Beaty (US 20050279647 A1; previously cited) which shows a verification process which compares the lot ID of the test strip with the data stored in the handheld analyzer and provides a warning when they do not match giving a chance to the user to insert the correct test strip.
The additional element in claim 11 of measuring a signal inconsistency is conventional as shown in [0013] of Elder (US 20150091592 A1; previously cited) which shows measuring signal inconsistency and in [0006] of Mackintosh et al. (US 20130217053 A1; previously cited) which shows measuring signal inconsistency of a test strip in a handheld analyzer.
The additional elements in claim 14 of applying an electrical signal to a test strip and measuring a response of a combination of the test strip and the bodily fluid sample to the applied to the electrical signal are conventional as shown by [009] and [0036] of Wang et al. (US 20170226557 A1; previously cited) and Column 24 of Hurd et al. (US 9,713,440 B2; previously cited).
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
Response to Arguments
Applicant's arguments filed 03 March 2026 have been fully considered but they are not persuasive.
Applicant argues that the claims require physical interaction between a handheld analyzer and a test strip, including "downloading ... and storing, on the handheld analyzer, a test strip type data and batch data," "verifying a test strip ... based on ... measuring an impedance of the test strip or measuring a current in the test strip with the handheld analyzer," and "measuring, with the handheld analyzer, a measure concentration of at least one analyte." Such operations cannot practically be performed in the human mind (Reply p. 9).
This argument has been fully considered but found to be not persuasive. It is noted that verifying a test strip falls under a mental process because the human mind is capable of comparing test data to determine a match and the human mind is capable of determining whether a test strip has been used by analyzing impedance or current measurement values. Further, the measurement of the impedance or current values along with other argued limitations are addressed as additional elements of the claim above (i.e., not identified as mental processes).
Applicant argues the amended limitations address a technical problem that arises in the field of analyte measurements for example the combination of features "automatically downloading ... and storing, on the handheld analyzer, a test strip type data and batch data, wherein the batch data comprises batch specific calibration coefficients," "verifying a test strip ... by comparing a type of the test strip to the downloaded test strip type data and determining whether the test strip has been used," "measuring an ambient temperature," "determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature," and "measuring ... a measured concentration of at least one analyte ... determined using the batch specific calibration coefficients of the test strip and the measured ambient temperature." These features address sources of measurement error that arise from differences between test strip types, variations in batches, and changes in temperature. (Reply p. 9-11).
This argument has been fully considered but found to be not persuasive. Due to the method including contingent limitations the steps of the method does not require outputting a prompt, measuring ambient temperature, determining whether a sample collect reached a stable temperature, or measuring an analyte value. Thus, the additional elements in the steps not required to be performed by the method cannot integrate the judicial exceptions into a practical application because there exists an embodiment where they are not performed.
Applicant argues that amended claim 1 improves upon both the field of analyte measurement and the functioning of a computer by saving computing resources, including memory, processing, and power. Applicant argues that the claims are analogous to example 40 in which a claimed system improved computer operations by dynamically controlling when monitoring occurred (Reply p. 10-11).
This argument has been fully considered but found to be not persuasive. Example 40 has a different fact pattern than the instant case due to the claims in example 40 being directed to a system that contains contingent limitations (which requires a system structured to operate in this manner). In contrast, the instant claims recite a method containing contingent limitations which are not required to be performed under the BRI of the claim. Thus, the claims do not require the steps of the method such as outputting a prompt, or measuring ambient temperature or measuring concentration.
Applicant argues that amended claim 1 recites significantly more than any abstract idea. As discussed above, Applicant's Specification explains that conventional point-of-care systems assume uniform conditions, require multiple devices, or rely on repeated measurements and post-hoc correction, making them inefficient and error-prone. The claimed subject matter does not recite merely collecting data but rather verifying the test strip based on "measuring an impedance of the test strip or measuring a current in the test strip" and "in response to determining that the sample has reached the stable target temperature" where such determination is made based on "at least ambient temperature or a rate of change in temperature." By conditioning analyte measurement on the test strip verification and temperature-based determination, the claimed subject matter reduces the risk of taking invalid or premature measurements, minimizes user error, and conserves computing and device resources (Reply p. 11).
This argument has been fully considered but found to be not persuasive. It is noted that measuring impedance or current is conventional as shown above. Further, due to the method including contingent limitations the steps of the method after the step of verifying are not required to be performed. Thus, the additional elements in the steps not required to be performed by the method cannot provide significantly more than the judicial exceptions because there exists an embodiment where they are not performed.
Claim Rejections - 35 USC § 103
The rejection on the ground of 103 claim 1-3, 10, 12 and 21 as being unpatentable over as being unpatentable over Wang et al. (US 20170226557 A1; previously cited) in view of Ackermann et al. (US 20080217407 A1; newly cited) in view of Nayak et al. (Analytical Chemistry 2017 89 (1), 102-123; previously cited) in Office action mailed 03 November 2025 is withdrawn in view of the amendments of “verifying a test strip inserted into the handheld analyzer based on 1) comparing a type of the test strip to the downloaded test strip type data to determine whether the type of the test strip matches the downloaded test strip type data and 2) determining whether the test strip has been used, wherein determining whether the test strip has been used comprises measuring an impedance of the test strip or measuring a current in the test strip with the handheld analyzer at a first time, in response to not verifying the test strip, outputting a prompt to remove the test strip, and at a second time, in response to verifying the test strip, measuring an ambient temperature, determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature, in response to determining that the sample has reached the stable target temperature” received 03 March 2026.
The rejection on the ground of 103 claim 4 as being unpatentable over Wang et al. in view of Ackermann et al. in view of Nayak et al. as applied to claims 1-3, 10, 12 and 21 above, and further in view of Krishnaswamy et al. (US 20020060247 A1; previously cited) in Office action mailed 03 November 2025 is withdrawn in view of the amendments indicated above received 03 March 2026.
The rejection on the ground of 103 claims 6, 7, and 24 as being unpatentable over Wang et al. in view of Ackermann et al. in view of Nayak et al. as applied to claims 1-3, 10, 12 and 21 above, and further in view of Beaty (US 20050279647 A1; previously cited) in Office action mailed 03 November 2025 is withdrawn in view of the amendments indicated above received 03 March 2026.
The rejection on the ground of 103 claims 9 and 11 as being unpatentable over Wang et al. in view of Ackermann et al. in view of Nayak et al. as applied to claims 1-3, 10, 12 and 21 above, and further in view of Elder (US 20150091592 A1; previously cited) in Office action mailed 03 November 2025 is withdrawn in view of the amendments indicated above received 03 March 2026.
The rejection on the ground of 103 claims 13, 22, and 23 as being unpatentable over Wang et al. in view of Ackermann et al. in view of Nayak et al. as applied to claims 1-3, 10, 12 and 21 above, and further in view of Goldstein et al. (US 20120083711 A1; previously cited) in Office action mailed 03 November 2025 is withdrawn in view of the amendments indicated above received 03 March 2026.
The rejection on the ground of 103 claim 14 as being unpatentable over Wang et al. in view of Ackermann et al. in view of Nayak et al. as applied to claims 1-3, 10, 12 and 21 above, and further in view of Irina et al. (US 20120165626 A1; previously cited) in Office action mailed 03 November 2025 is withdrawn in view of the amendments indicated above received 03 March 2026.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejection below is newly recited necessitated by amendment.
Claims 1-4, 10-13, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ackermann et al. (US 20080217407 A1; previously cited) in view of Harrison et al. (US 20140027308 A1; newly cited).
Claim 1 is directed to a method of measuring an analyte in a bodily fluid sample and combining measurement data from multiple users, the method comprising: initiating a wireless connection between a handheld analyzer and a computing device on which an analyte analysis application has been downloaded, automatically downloading over the wireless connection and storing, on the handheld analyzer, a test strip type data and batch data, wherein the batch data comprises batch specific calibration coefficients,
Ackermann et al. show a manufacturer or distributor of the test strips maintains a central database containing a lot data file containing a set of identification codes which are associated with a respective set of calibration data (Ackermann et al. [0021]). Ackermann et al. shows a handheld diagnostic device downloads the lot data file from the system by means of some appropriate electronic communication protocol to access the necessary calibration data which can be specific to one or more lots (Ackermann et al. [0022]). Ackermann et al. shows the lot data file is distributed to the handheld analyzer over a wireless network (Ackermann et al. [0022]).
verifying a test strip inserted into the handheld analyzer based on 1) comparing a type of the test strip to the downloaded test strip type data to determine whether the type of the test strip matches the downloaded test strip type data
Ackermann et al. shows a strips lot identification code is provided on the test strip and the device will read the lot identification code and checks if the read lot identification code matches a lot identification code provided in the stored lot data file (Ackermann et al. [0037]-[0038]).
Ackermann et al. shows not show determining whether the test strip has been used, wherein determining whether the test strip has been used comprises measuring an impedance of the test strip or measuring a current in the test strip with the handheld analyzer
Like Ackermann et al., Harrison et al. shows using a test meter device which utilizes a test strip to measure an analyte. Harrison et al. shows measuring a current flow of electrodes of a test strip and determining based on the measured current flow whether the strip has been previously used (Harrison et al. [0014]). Harrison et al. shows that dried used test strip will exhibit high resistance and low or zero current flow between the electrodes which can be detected (Harrison et al. [0036]). Harrison further shows if the test strip is detected as having been previously used an error message is displayed and the test process is terminated (Harrison et al. [0036]).
at a first time, in response to not verifying the test strip, outputting a prompt to remove the test strip, and at a second time, in response to verifying the test strip, measuring an ambient temperature, determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature, in response to determining that the sample has reached the stable target temperature, measuring, with the handheld analyzer, a measured concentration of at least one analyte in the sample collected on the test strip inserted into the handheld analyzer, the measured concentration determined using the batch specific calibration coefficients of the test strip and the measured ambient temperature; and outputting the measured concentration to a user and/or wirelessly communicating the measured concentration to the computing device.
The BRI of the claimed method does not require the step of outputting a prompt to remove the test strip because it is contingent on the condition of not verifying the test strip at a first time being met. The BRI of the claimed method does not require the steps of measuring an ambient temperature and determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature because they are contingent on the condition of verifying the test strip at a second time being met. The BRI of the claimed method does not require the steps of measuring, with the handheld analyzer, a measured concentration of at least one analyte in the sample collected on the test strip inserted into the handheld analyzer, the measured concentration determined using the batch specific calibration coefficients of the test strip and the measured ambient temperature and outputting the measured concentration to a user and/or wirelessly communicating the measured concentration to the computing device because they are contingent on the condition of verifying the test strip at a second time being met and the condition that the sample has reached the stable target temperature being met.
Claim 24 is directed to initiating a wireless connection between a handheld analyzer and a computing device on which an analyte analysis application has been downloaded, automatically downloading over the wireless connection and storing, on the handheld analyzer, downloaded test strip type data and downloaded batch data, wherein the downloaded batch data comprises batch specific calibration coefficients
Ackermann et al. show a manufacturer or distributor of the test strips maintains a central database containing a lot data file containing a set of identification codes which are associated with a respective set of calibration data (Ackermann et al. [0021]). Ackermann et al. shows a handheld diagnostic device downloads the lot data file from the system by means of some appropriate electronic communication protocol to access the necessary calibration data which can be specific to one or more lots (Ackermann et al. [0022]). Ackermann et al. shows the lot data file is distributed to the handheld analyzer over a wireless network (Ackermann et al. [0022]).
verifying a test strip inserted into the handheld analyzer based on 1) comparing a type of the test strip to the downloaded test strip type data to determine whether the type of the test strip matches the downloaded test strip type data
Ackermann et al. shows a strips lot identification code is provided on the test strip and the device will read the lot identification code and checks if the read lot identification code matches a lot identification code provided in the stored lot data file (Ackermann et al. [0037]-[0038]).
Ackermann et al. shows not show determining whether the test strip has been used based on measuring an impedance of the test strip or measuring a current in the test strip
Like Ackermann et al., Harrison et al. shows using a test meter device which utilizes a test strip to measure an analyte. Harrison et al. shows measuring a current flow of electrodes of a test strip and determining based on the measured current flow whether the strip has been previously used (Harrison et al. [0014]). Harrison et al. shows that dried used test strip will exhibit high resistance and low or zero current flow between the electrodes which can be detected (Harrison et al. [0036]). Harrison further shows if the test strip is detected as having been previously used an error message is displayed and the test process is terminated (Harrison et al. [0036]).
at a first time, in response to not verifying the test strip, outputting a prompt to remove the test strip, and at a second time, in response to verifying the test strip: measuring, with the handheld analyzer, a measured concentration of at least one analyte in a sample collected on the test strip, the measured concentration determined using the batch specific calibration coefficients, wirelessly communicating the measured concentration from the handheld analyzer to the computing device, displaying the measured concentration on the computing device, transmitting the measured concentration to a database, and organizing data including the measured concentration and at least one additional measured analyte concentration from at least one additional user on the database.
The BRI of the claimed method does not require the step of outputting a prompt to remove the test strip because it is contingent on the condition of not verifying the test strip at a first time being met. The BRI of the claimed method does not require the steps of measuring, with the handheld analyzer, a measured concentration of at least one analyte in a sample collected on the test strip, the measured concentration determined using the batch specific calibration coefficients, wirelessly communicating the measured concentration from the handheld analyzer to the computing device, displaying the measured concentration on the computing device, transmitting the measured concentration to a database, and organizing data including the measured concentration and at least one additional measured analyte concentration from at least one additional user on the database because they are contingent on the condition of verifying the test strip at a second time being met.
Claim 2 is directed to wirelessly communicating the measured concentration from the handheld analyzer to the computing device, displaying the measured concentration on the computing device, transmitting the measured concentration to a database, and organizing data including the measured concentration and at least one additional measured analyte concentration from at least one additional user on the database, wherein the database is on a cloud storage location, and wherein transmitting the measured concentration to the database comprises wirelessly transmitting the measured concentration from the computing device to the cloud storage via the internet. Claim 3 is directed to the data being organized based upon groups of multiple users belonging to multiple organizations. Claim 12 is directed to using the computing device to analyze the measured concentration to assist in user interpretation analyze the measured concentration to assist in user interpretation. Claim 13 is directed to wherein the computing device refers the measured concentration to a threshold. Claim 21 is directed transferring the measured concentration to another device to at least one of display the measured concentration, generate further calculations, or store the measured concertation. Claim 22 is directed to providing at least one recommended action based on the measured concentration. Claim 23 is directed to wherein the recommended action is a hydration recommendation.
The BRI of the claimed method does not require these steps to be performed because these steps are contingent on the condition of verifying the test strip at a second time and on the condition that the sample has reached the stable target temperature to be met to obtain the measured concentration. These conditions are not required to be met by the method.
Claim 4 is directed to initiating the measuring step via the computing device, wherein initiating the measuring step comprises logging into an operator account on an application, selecting a source from which the sample will be taken and confirming wireless connection between the analyzer and the computing device.
The BRI of the claimed method does not require these steps to be performed because these steps are contingent on the condition of verifying the test strip at a second time and on the condition that the sample has reached the stable target temperature to be met to perform/initiate the measuring step. These conditions are not required to be met by the method.
Claim 10 is directed to using the handheld analyzer, applying a detection technique based on the ambient temperature.
The BRI of the claimed method does not require this step to be performed because this step is contingent on the condition of verifying the test strip at a second time being met before the ambient temperature is measured. This condition is not required to be met by the method.
Claim 11 is directed to measuring signal inconsistency and detecting abnormally high signal from test strip.
Harrison et al. shows that dried used test strip will exhibit high resistance and low or zero current flow between the electrodes which can be detected (Harrison et al. [0036]). Harrison further shows if the test strip is detected as having been previously used an error message is displayed and the test process is terminated (Harrison et al. [0036]).
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to combine reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date to have combined the verification process of matching a test strip ID to stored test strip data of Ackermann et al. with the process of measuring a current of a test strip to determine if the test strip was previously used because this would allow a process which reduces errors in the use of a test meter with test strips leading to accurate analyte measurements by checking that the test meter includes calibration data for a particular test strip (Ackermann et al. [021]-[022]) and determining if the test strip was previously used to avoid inaccurate analyte measurements (Harrison et al. [0005]). One would have a reasonable expectation of success because both Ackermann et al. and Harrison et al. provide processes of checking test strips to reduce errors in analyte measurement processes.
The rejection below is newly recited necessitated by amendment.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ackermann et al. in view of Harrison et al. as applied to claims 1 above, and further in view of Beaty (US 20050279647 A1; previously cited).
Claim 6 is directed to measuring a resistance encoded test strip identification on the test strip and comparing the identification in a memory of the handheld analyzer to determine the test strip type and batch data. Claim 7 is directed to communicating data and alerting a user through an error message on the handheld analyzer and computing device if the test strip type is an unknown test strip type.
Ackermann et al. in view of Harrison et al. as applied to claims 1 does not measuring a resistance encoded test strip and comparing the identification in a memory of the handheld analyzer (in claim 6), communicating data and alerting a user through an error message on the handheld analyzer and computing device if the test strip type is an unknown test strip type (in claim 7).
Like Ackermann et al. in view of Harrison et al., Beaty shows a test strip verification process by detecting a test strip ID on the test strip. Beaty shows comparing the test strip identification with the data in the memory to determine the test strip type and batch data (Beaty [0058]). Beaty shows alerting the user through an error message one the handheld analyzer if the test strip type is an unknown test strip type (Beaty [0058]). Beaty shows measuring a resistance encoded test strip identification (Beaty [066]). Beaty shows a verification process which compares the lot ID of the test strip with the data stored in the handheld analyzer and provides a warning when they do not match giving a chance to the user to insert the correct test strip (Beaty [058]). Beaty shows once it has been determined that the test meter’s calibration code lot ID matches the lot ID of the test strip, then the measurement sequence can continue (Beaty [061]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted the process of detecting a test strip ID on a test strip of Ackermann et al. in view of Harrison et al. with the detection of a test strip ID on a test strip by measuring a resistant strip identification and alerting the user through error messages if there is not a match of Beaty because both Ackermann et al. in view of Harrison et al. show detecting test strip IDs on a test strip using a test meter and this would lead to predictable results of a process that verifies if the lot data and currently loaded calibration data matches the inserted test strip by measuring a resistance encoded ID on the test strip and prompts the user through error messages that the test strip is unknown or does not match in order to resolve the issue through using different lot data/loaded calibration data.
The rejection below is newly recited necessitated by amendment.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ackermann et al. in view of Harrison et al. as applied to claim 1 above, and further in view of Elder (US 20150091592 A1; previously cited).
Claim 9 is directed to providing instructions to a user regarding how to perform a test.
Ackermann et al. in view of Harrison et al. as applied to claim 1 does not show providing instructions on how to collect a sample on the analyzer.
Like Ackermann et al. in view of Harrison et al., Elder shows using a handheld analyzer for determining a concentration of an analyte. Elder further shows the display can instructions to a user on how to perform a test (Elder [0020]).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the process of utilizing the handheld analyzer in Ackermann et al. in view of Harrison et al. with the process of the handheld analyzer providing instructions on how to perform a test of Elder because this provide a process which results in reduced errors in testing by providing a user instructions on how to perform a test which (Elder [0020]). One would have a reasonable expectation of succuss because Ackermann et al. in view of Harrison et al. shows the use of a handheld analyzer with a test strip and Elder shows a process of using a handheld analyzer.
The rejection below is newly recited necessitated by amendment.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ackermann et al. in view of Harrison et al. as applied to claims 1 above, and further in view of Irina et al. (US 20120165626 A1; previously cited).
Claim 14 is directed to applying an electrical signal to the test strip, measuring a response of a combination of the test strip and the bodily fluid sample and analyzing the response with the device to determine the fluid sample is a valid sample.
Ackermann et al. in view of Harrison et al. as applied to claims 1 does not show analyzing the response to determine the fluid sample is a valid sample.
Like Ackermann et al. in view of Harrison et al., Irina et al. shows analyzing biological fluid data with test strips. Irina et al. shows using data to determine whether a sufficient quantity of fluid is present for accurate testing (Irina et al [0089]). This is determining the validity of a sample.
It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the data analysis in Ackermann et al. in view of Harrison et al. as applied to claims 1 with analyzing the data to determine if the sample is a valid sample of Irina et al. because this would give an analysis that checks if the sample is valid and can be used for further data analysis (Irina et al [0089]). One would be motivated to make this modification because this provides more accurate data analysis by only using valid samples. One would have a reasonable expectation of succuss because Ackermann et al. in view of Harrison et al. shows the analysis of similar data shown in Irina et al.
The rejection below is newly recited necessitated by amendment.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ackermann et al. in view of Harrison et al. as applied to claims 1 above, and further in view of Iyengar et al. (US 20160061763 A1; newly cited).
Claim 25 is directed to wherein the handheld analyzer is configured to receive a plurality of different test strip types, and wherein the handheld analyzer is configured to, based on the test strip type data, automatically adjust at least one of 1) a detection method, 2) an excitation waveform, or 3) gain settings.
Ackermann et al. in view of Harrison et al. as applied to claims 1 above does not show a handheld analyzer that is configured to receive a plurality of different test strip types, and wherein the handheld analyzer is configured to, based on the test strip type data, automatically adjust at least one of 1) a detection method, 2) an excitation waveform, or 3) gain settings.
Like Ackermann et al. in view of Harrison et al., Iyengar et al. shows a test meter which reads encoded test strips to determine information of the test strip. Iyengar et al. shows a test meter which is configured to receive multiple test strips and read the coded information which includes calibration code for a test strip batch and assay type (e.g., glucose test strip or ketone test strip) (Iyengar et al. [0077]). Iyengar et al. shows when a test strip is inserted the encoding pads are interrogated through the to provide strip specific information to assist in the presentation of accurate test results with minimum user intervention (Iyengar et al. [0082]).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to modify reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the handheld analyzer in the use of the method of Ackermann et al. in view of Harrison et al. to be the handheld analyzer of Iyengar et al. because this would allow for the process to utilize a handheld analyzer which reads a plurality of test strips (e.g., glucose test strip or ketone test strip) with encoded information (e.g., calibration code for a test strip batch and assay type) and is configured to provide this information to the device to assist in the presentation of accurate test results with minimum user intervention (Iyengar et al. [0082]). One would have a reasonable expectation of success because Ackermann et al. in view of Harrison et al. and Iyengar et al. use test meters which detect test strip encoded information to provide accurate results for particular test strips.
Response to Arguments
Applicant's arguments filed 03 March 2026 have been fully considered but they are not persuasive.
Applicant argues that Wang, Ackermmann, Nayak, Beaty, or Elder et al does not show verifying “whether the test strip has been used based on measuring an impedance of the test strip or measuring the current in the test strip” (Reply p. 13).
This argument has been fully considered. It is noted that Harrison et al. is provided under a new ground of rejection necessitated by amendment to show this limitation.
Applicant argues that the cited references do not disclose or suggest, at least, "at a first time, in response to not verifying the test strip, outputting a prompt to remove the test strip," and "at a second time, in response to verifying the test strip: measuring an ambient temperature; determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature; in response to determining that the sample has reached the stable target temperature, measuring, with the handheld analyzer a measured concentration of at least one analyte" as recited in amended claim 1 (Reply p. 13).
This argument has been fully considered but found to be not persuasive. As stated above, a new ground of rejection necessitated by amendment is provided. Further, it is noted that these limitations are contingent limitations and are not required to be practiced by the method under the BRI due to conditions in the claim not required to be met.
Applicant argues that the cited references do not disclose or suggest "determining, based on at least the ambient temperature or a rate of change in temperature, whether a sample collected on the test strip has reached a stable target temperature." (Reply p. 13).
This argument has been fully considered but found to be not persuasive. As stated above, a new ground of rejection necessitated by amendment is provided. Further, it is noted that these limitations are contingent limitations and are not required to be practiced by the method under the BRI due to conditions in the claim not required to be met.
Applicant argues that Elder and Beaty do not show newly amended claim 25 (Reply p. 14).
This argument has been fully considered but found to be not persuasive. As stated above, a new ground of rejection necessitated by amendment is provided and Elder or Beaty are not relied upon to address claim 25.
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.
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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