DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 6-11 in the reply filed on 10/07/2025 is acknowledged.
Claim Rejections - 35 USC § 112
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 6-11 are 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.
Claims 6 & 10 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 6 is vague and unclear reciting “a processor programmed to perform the steps of: measuring hematocrit in the sample placed onto the test strip using the sense measurement signals to calculate a hematocrit complex impedance value; and mapping the calculated hematocrit impedance to a hematocrit concentration in the sample”. It is unclear if the applicant is claiming the processor’s capabilities to be programmed to perform the claimed steps, since additional structure, such as a non-transitory computer readable memory programmed with instructions to perform the claimed steps would be required.
Claim 10 is vague and unclear reciting “wherein the processor further performs the step of calculating a concentration of glucose in the sample using the mapped hematocrit concentration and a glucose measurement from the at least one glucose trace”, because it is unclear how the processor as claimed “further performs the step of calculating a concentration of glucose in the sample using the mapped hematocrit concentration and a glucose measurement from the at least one glucose trace” without a non-transitory computer readable memory programmed with instructions to perform the claimed step.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leone (US 2020/0253514) in view of Udupa et al. (US 2018/0214084).
Regarding claim 6, Leone teaches:
6. A system for diagnostic testing (i.e., There is provided a system for measuring a property of a sample that comprises a test strip for collecting the sample; a diagnostic measuring device configured to receive the test strip and measure a concentration of an analyte in the sample received on the test strip; and the diagnostic measuring device [...] Abstract), comprising:
a test strip (e.g., 10, Fig. 1A & ¶ 0034) comprising:
first and second excitation traces (e.g., 17) capable for excitation signals and first and second sensing traces (e.g., 17) capable for separate sense measurement signals (see i.e., The conductive pattern may include a plurality of electrodes 15 disposed on base layer 16 near proximal end 12, a plurality of electrical strip contacts 19 disposed on base layer 16 near distal end 14, ¶ 0036 & Fig. 1B; [...] the HCT measurement sequence begins after a drop of blood or control is detected when the drop completes the circuit between the HCT measurement anode and cathode. ¶ 0042; The cathode current is measured with a transimpedance amplifier (TIA) which generates a current propostional to voltage, in this case at the frequency of excitation. ¶ 0058); and
one or more electrodes (e.g., 15) in electrical communications with excitation traces and sense traces (see i.e., The conductive pattern may include a plurality of electrodes 15 disposed on base layer 16 near proximal end 12, a plurality of electrical strip contacts 19 disposed on base layer 16 near distal end 14, and a plurality of conductive traces 17 electrically connecting the electrodes 15 to the plurality of electrical strip contacts 19. ¶ 0036 & Fig. 1B; the HCT measurement sequence begins after a drop of blood or control is detected when the drop completes the circuit between the HCT measurement anode and cathode ¶ 0042); and
an electronic meter (e.g., 100) for performing a diagnostic test on a sample applied to the test strip inserted therein (Fig. 2A and Fig. 2B illustrate, an exemplary illustration of a meter 100 used to measure the glucose level in a blood sample. ¶ 0038), the electronic meter comprising:
a housing having a test port for receiving the test strip (The meter 100 includes a housing having a test port for receiving the test strip [...] ¶ 0038),
a circuit configured to measure hematocrit and in electrical communication with the first and second excitation traces and the first and second sensing traces (Other methods may also be used, such as inserted conductors with physical attachment to control circuit. ¶ 0036; the HCT measurement sequence begins after a drop of blood or control is detected when the drop completes the circuit between the HCT measurement anode and cathode. ¶ 0042), and
a processor (The meter 100 includes [...] a processor or microprocessor programmed to perform methods and algorithms to determine glucose concentration in a test sample or control solution as disclosed in the present disclosure. ¶ 0038 & Figs. 2A-2B) programmed to perform the steps of:
measuring hematocrit in the sample placed onto the test strip using the sense measurement signals to calculate a hematocrit complex impedance value (see i.e., a method of measuring the HCT for a blood glucose meter can mix analog and digital circuitry to measure the HCT complex impedance (HCT impedance magnitude and phase) ¶ 0046); and
mapping the calculated hematocrit impedance to a hematocrit concentration in the sample (The meter can measure blood glucose by analysing the electrical response to an excitation signal. However, this response is dependent on the HCT concentration in the blood. The accuracy of the glucose measurement is therefore dependent on the accuracy of the HCT concentration to compensate the measurement for this interferent. For a given blood glucose sample, the peak response current to a voltage excitation used to measure blood glucose on the blood sample can be inversely proportional to the HCT concentration in the blood. Knowing the HCT impedance provides the data to map the HCT concentration to the peak current through empirical methods. ¶ 0044).
Regarding claim 6, Leone does not explicitly teach: one or more electrodes in electrical communications with the first and second excitation traces and the first and second sense traces.
Udupa et al., drawn to measuring and testing, teach one or more electrodes in electrical communications with the first and second excitation traces and the first and second sense traces (The excitation source 110 is coupled between a pair of excitation electrodes 104 and 106. The excitation electrodes 104 and 106 are coupled to the human body 102. A pair of sense electrodes 114 and 116 is also coupled to the human body 102. ¶ 0013 & Fig. 1).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the system, as disclosed by Leone, as to include one or more electrodes in electrical communications with the first and second excitation traces and the first and second sense traces, as taught by Udupa et al., to improve the accuracy of the system. (see Udupa et al. ¶ 0005-0006).
Regarding claims 7-10, modified Leone teaches:
7. The system of claim 6, wherein the first excitation trace (17) on the test strip (10) is configured to send an excitation signal to a HCT cathode on the test strip, and the first sense trace on the test strip is configured to send a sense measurement signal to the HCT cathode on the test strip (see i.e., The conductive pattern may include a plurality of electrodes 15 disposed on base layer 16 near proximal end 12, a plurality of electrical strip contacts 19 disposed on base layer 16 near distal end 14, and a plurality of conductive traces 17 electrically connecting the electrodes 15 to the plurality of electrical strip contacts 19. ¶ 0036 & Fig. 1B; the HCT measurement sequence begins after a drop of blood or control is detected when the drop completes the circuit between the HCT measurement [...] cathode ¶ 0042; The cathode current is measured with a transimpedance amplifier (TIA) which generates a current propostional to voltage, in this case at the frequency of excitation. ¶ 0058).
8. The system of claim 6, wherein the second excitation trace on the test strip is configured to send an excitation signal to a HCT anode on the test strip, and the second sensing trace on the test strip is configured to send a measurement signal to the HCT anode on the test strip (see i.e., The conductive pattern may include a plurality of electrodes 15 disposed on base layer 16 near proximal end 12, a plurality of electrical strip contacts 19 disposed on base layer 16 near distal end 14, and a plurality of conductive traces 17 electrically connecting the electrodes 15 to the plurality of electrical strip contacts 19. ¶ 0036 & Fig. 1B; the HCT measurement sequence begins after a drop of blood or control is detected when the drop completes the circuit between the HCT measurement anode ¶ 0042; The anode, excited by voltage excitation V(ω) goes to a gain stage with peak detected to be measured by the microcontroller ADC. ¶ 0058).
9. The system of claim 6, further comprising at least one glucose contact (19) configured for electrical communication with at least one glucose trace on the test strip (The BGM measures blood glucose by analyzing the electrical response to an excitation signal. ¶ 0031; The conductive pattern may include a plurality of electrodes 15 disposed on base layer 16 near proximal end 12, a plurality of electrical strip contacts 19 disposed on base layer 16 near distal end 14 Fig. 1B, ¶ 0036; a reagent layer may be disposed on the base layer 16 of the strip 10 in contact with at least a working electrode of the conductive pattern. The reagent layer may include an enzyme, such as glucose oxidase, and a mediator, such as potassium ferricyanide or ruthenium hexamine. Reagent layer 90 may also include other components, [...] With these chemical constituents, the reagent layer reacts with glucose in the blood sample in the following way ¶ 0037).
10. The system of claim 9, wherein the processor is capable of performing the step of calculating a concentration of glucose in the sample using the mapped hematocrit concentration and a glucose measurement from the at least one glucose trace (see i.e., a processor or microprocessor programmed to perform methods and algorithms to determine glucose concentration in a test sample or control solution as disclosed in the present disclosure. ¶ 0038).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leone (US 2020/0253514) in view of Udupa et al. (US 2018/0214084), and further in view of Neel et al. (US 2007/0089987).
Regarding claim 11, modified Leone does not explicitly teach: 11. The system of claim 6, further comprising at least one fill contact configured for electrical communication with at least one fill trace on the test strip.
Neel et al., drawn to blood sample testing, teach: at least one fill contact configured for electrical communication with at least one fill trace on the test strip (Conductive pattern 20 includes a plurality of electrodes disposed on base layer 18 near proximal end 12, a plurality of electrical contacts disposed on base layer 18 near distal end 14, and a plurality of conductive traces electrically connecting the electrodes to the electrical contacts. In a preferred embodiment, the plurality of electrodes includes a working electrode 22, a counter electrode 24, which may include a first section 25 and a second section 26, a fill-detect anode 28, and a fill-detect cathode 30. Correspondingly, the electrical contacts may include a working electrode contact 32, a counter electrode contact 34, a fill-detect anode contact 36, and a fill detect cathode contact 38. The conductive traces may include a working electrode trace 40, electrically connecting working electrode 22 to working electrode contact 32, a counter electrode trace 42, electrically connecting counter electrode 24 to counter electrode contact 34, a fill-detect anode trace 44 electrically connecting fill-detect anode 28 to fill-detect contact 36, and a fill-detect cathode trace 46 electrically connecting fill-detect cathode 30 to fill-detect cathode contact 38. In a preferred embodiment, conductive pattern 20 also includes an auto on conductor 48 disposed on base layer 18 near distal end 14. ¶ 0043 & Fig. 3).
It would have been obvious to one of ordinary skill in the art at the time of invention to further modify the system of Leone, as to include at least one fill contact configured for electrical communication with at least one fill trace on the test strip, as taught by Neel et al., to improve the convenience and reliability of the system (see Neel et al. ¶ 0007-0008).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JILL A. WARDEN can be reached at (571) 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798