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 .
The response dated 11/10/2025 is acknowledged. Claims 8-20 are pending. Claims 1-7 are cancelled. Claims 8-20 are considered on the merits below.
Response to Amendment
Applicant's amendments, filed 11/10/2025, with respect to the 112b rejection have been fully satisfied and withdrawn.
In response to the applicant's amendments, the art grounds of rejection for claims 8-20 are maintained compared to the previous action. The rejection of claim 15 has been updated due to the amendment.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 8-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Connolly (US 5,597,532, provided on the IDS on 10/7/2024).
Regarding claim 8, Connolly describes a method of measuring analyte concentrations utilizing a reflectance based colorimetric test strip reader operably coupled with a mobile device (abstract and figures 1-5 and column 10 “a removable EEPROM unit 84 (mobile device) operably connected to microprocessor/microcontroller 80”), the method comprising:
receiving a bodily fluid sample on a test strip (column 4 “test strip 12 defines an area for depositing a body fluid sample”);
activating a light source positioned within the reflectance based colorimetric test strip reader to illuminate a reaction area of said test strip in response to insertion of said test strip into a test strip receiving channel of the reflectance based colorimetric test strip reader (figure 5, column 10 “One or more light sources 70, for example high intensity light emitting diodes (LED) are disposed in housing 50 to illuminate test strip 12”);
determining an analyte concentration of said bodily fluid sample with a light sensor in the reflectance based colorimetric test strip reader based on a color profile change of said test strip (figures 1 and 5, column 9 “a test strip holding region 52 is located above three light detectors or sensors 54 each disposed within a port 56.” and column 11 “this measurement algorithm then determines the concentration of the test to be measured by comparing the measured density (darkness) of the color formed and comparing this density number to a table of values through the use of an algorithm stored in the EEPROM unit 84.”); and
transmitting a signal corresponding to said analyte concentration from the light sensor to said mobile device (column 11 “When the end of the chemistry reaction has occurred, then the instrument measures the final density and compares it to a measurement algorithm stored in EEPROM unit 84 (mobile device). This measurement algorithm then determines the concentration of the test to be measured by comparing the measured density (darkness) of the color formed and com paring this density number to a table of values through the use of an algorithm stored in the EEPROM unit 84.”).
Regarding claim 9, Connolly describes the method of claim 8, wherein activating said light source comprises receiving a signal from said mobile device corresponding to a configuration profile, and wherein said configuration profile is dynamically updated to modify parameters of said light source during use (column 11 “Instrument 10 can use different wavelengths at different density portions of the reaction to maximize the dynamic range of the chemistry and the limits of the instrument at a particular wavelength.”).
Regarding claim 10, Connolly describes the method of claim 9, wherein said configuration profile is stored in a storage medium (column 11 “a measurement algorithm stored in EEPROM unit 84.”).
Regarding claim 11, Connolly describes the method of claim 9, wherein said configuration profile is downloaded from a server via said mobile device (column 11 “the instrument downloads the information contained in the EEPROM and proceeds with the test analysis.”).
Regarding claim 12, Connolly describes the method of claim 8, wherein the signal from said light sensor corresponds to a measured reflected light intensity (column 9 “Light sensors may take a reading from light reflected from the exposed test reaction membrane layer 32 or from test strip 12 itself to determine its color.”).
Regarding claim 13 Connolly describes the method of claim 8, wherein the bodily fluid sample comprises a fluid selected from the group consisting of blood, urine, and saliva (column 2 “The present invention, in one form thereof, comprises a dry solid phase diagnostic test strip and system for the chemical, enzymatic, and/or immunological analysis of whole blood analytes,”).
Regarding claim 14, Connolly describes the method of claim 8 further comprising, displaying the analyte concentration on a graphical user interface of said mobile device (figure 5 “EEPROM unit 84 (mobile device)” is connected to the “display 58”).
(Examiner’s note regarding jack plug: from specification pages 9-10 “although generally referred to herein as "jack plug," jack plug 20 can include any wired or wireless communication element”)
Regarding claim 15, Connolly describes a method of using a test strip reader communicably coupled with a mobile device (abstract and figures 1-5 and column 10 “a removable EEPROM unit 84 (mobile device) operably connected to microprocessor/microcontroller 80”),
the test strip reader having a housing, a jack plug, a test strip adapter including a test strip receiving channel, and an optical sub-system including a light source positioned within housing (figure 1 and column 9 “Photometric device 10 as shown in FIG. 1 includes a hand-held housing 50 for containing electronic control circuitry for operating the aforementioned tests. In the embodiment shown in FIG. 1, a test strip holding region 52 is located above three light detectors or sensors 54 each disposed within a port 56 (test strip adapter/receiving channel).” And column 10 “One or more light sources 70, for example high intensity light emitting diodes (LED) are disposed in housing 50 to illuminate test strip 12… [and] EEPROM unit 84 is an interchangeable plug-in memory module” See “jack plug” definition in examiner’s note.),
the method comprising:
coupling the test strip reader to the mobile device and powering the test strip reader (column 10 “a removable EEPROM unit 84 operably connected to microprocessor/microcontroller 80. EEPROM unit 84 is an interchangeable plug-in memory module containing measurement parameters, software, calibration data, and reagent recognition data for particular test strips 12.” And column 2 “The photometer includes a separate optical read head that determines the color and shade of the base of the test strip device as the strip is inserted into the photo metric instrument.” i.e. it is toggled/powered on when inserted);
activating the light source to illuminate a reaction area of a test strip in response to insertion of said test strip into said test strip receiving channel; illuminating a reaction area of said test strip utilizing said light source of said optical sub-system (column 10 “As the strips 12 are inserted into device 10, the instrument detects a change in the measurement area. This change indicates that a strip 12 has been inserted into the instrument 10. As the instrument detects the insertion of a test strip 12, it reads the densities of at least one of the LED's”);
detecting a bodily fluid sample deposited on said test strip (column 11 “The separated fluid, i.e. the plasma, sera, or other analyte containing portions, moves to the test reaction membrane layer 32 below the separation membrane 30. The above fluid migration causes the reactants (analytes such as glucose) in the sample to come into contact with the reactants in test reaction membrane layer 32.”);
determining an analyte concentration of said bodily fluid sample based on a color profile change of said test strip, the color profile change detected by a light sensor in the test strip receiving channel (figures 1 and 5, column 9 “a test strip holding region 52 is located above three light detectors or sensors 54 each disposed within a port 56.” and column 11 “this measurement algorithm then determines the concentration of the test to be measured by comparing the measured density (darkness) of the color formed and comparing this density number to a table of values through the use of an algorithm stored in the EEPROM unit 84.”); and
transmitting a signal corresponding to said analyte concentration to said mobile device (column 11 “When the end of the chemistry reaction has occurred, then the instrument measures the final density and compares it to a measurement algorithm stored in EEPROM unit 84 (mobile device). This measurement algorithm then determines the concentration of the test to be measured by comparing the measured density (darkness) of the color formed and com paring this density number to a table of values through the use of an algorithm stored in the EEPROM unit 84.”).
Regarding claim 16, Connolly describes the method of claim 15, wherein powering said test strip reader further comprises toggling a strip switch arranged on a surface of said test strip reader (column 2 “The photometer includes a separate optical read head that determines the color and shade of the base of the test strip device as the strip is inserted into the photo metric instrument.” i.e. it is toggled on when inserted).
Regarding claim 17, Connolly describes the method of claim 15 further comprising processing said signal corresponding to said analyte concentration for display on a graphical user interface of said mobile device (figure 5 “EEPROM unit 84 (mobile device)” is connected to the “display 58”).
Regarding claim 18, Connolly describes a method comprising:
providing a test strip reader to a user, the test strip reader including a housing, a test strip adapter and an optical sub-system (figure 1 and column 9 “Photometric device 10 as shown in FIG. 1 includes a hand-held housing 50 for containing electronic control circuitry for operating the aforementioned tests. In the embodiment shown in FIG. 1, a test strip holding region 52 is located above three light detectors or sensors 54 each disposed within a port 56 (test strip adapter/receiving channel).”); and
providing instructions to the user for performing an analyte analysis test with the test strip reader (column 11 “the instrument instructs the user”),
the instructions comprising:
coupling the test strip reader to a mobile device (column 2 “the user is instructed to insert the correct memory module.”);
inserting a test strip into an adapter channel of said test strip adapter (column 10 “the strips 12 are inserted into device 10”);
receiving a bodily fluid sample on said test strip (column 11 “then the instrument instructs the user to apply a sample.”);
causing said test strip reader to measure an analyte concentration of said bodily fluid sample with a light sensor in the adapter channel (column 11 “A sample is then applied and instrument 10 begins a measurement cycle” and column 9 “light detectors or sensors 54 each disposed within a port 56.”); and
causing said test strip reader to transmit data corresponding to said analyte concentration to said mobile device for display on a graphical user interface (figure 5 “EEPROM unit 84 (mobile device)” is connected to the “display 58” and column 11 “When the end of the chemistry reaction has occurred, then the instrument measures the final density and compares it to a measurement algorithm stored in EEPROM unit 84 (mobile device). This measurement algorithm then determines the concentration of the test”).
Regarding claim 19, Connolly describes the method of claim 18, wherein the instructions for performing said analyte analysis test further comprises causing said mobile device to transmit a configuration profile to said test strip reader (column 11 “the instrument downloads the information contained in the EEPROM and proceeds with the test analysis.”).
Regarding claim 20, Connolly describes the method of claim 18, wherein the instructions for performing said analyte analysis test further comprises executing a device characterization to compensate device variations of said test strip reader (column 12 “Multiple wavelengths can also be used with different angles of emission to correct possible problems in positioning the strip in the instrument.”).
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
The applicant argues that (1) the prior art does not teach “transmitting a signal”, it only teaches “storing”; (2) the prior art des not describe a graphical user interface; (3) the “mobile device” of the prior art does not meet the requirements of the claim.
In response to the applicant’s argument that (1) the prior art does not teach “transmitting a signal”, it only teaches “storing”, as indicated in the rejection above the prior art describes “comparing this density number to a table of values through the use of an algorithm stored in the EEPROM unit 84” (column 11). The data/signal must be transmitted in order for the comparing to stored information to occur. Thus the prior art meets the limitation of the claim.
In response to the applicant’s argument that (2) the prior art des not describe a graphical user interface, as indicated in the rejection above the prior art describes a display 58 (figure 5). This is a graphical user interface. Thus the prior art meets the limitation of the claim.
In response to the applicant’s argument that (3) the “mobile device” of the prior art does not meet the requirements of the claim, as indicated in the rejection above the prior art describes a removable EEPROM unit 84. This can be considered the mobile device as it is able to be removed and mobile. Thus the prior art meets the limitation of the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R BERKELEY whose telephone number is (571)272-9831. The examiner can normally be reached M-Th 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at 571-272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY R. BERKELEY/
Examiner
Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796