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 1-13 and 15-19, in the reply filed on12/11/2025 is acknowledged.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking
claim. Election was made without traverse in the reply filed on 12/11/2025.
Claim Interpretation
Non-dosed amount is being interpreted to mean an unmeasured amount.
Claim Rejections - 35 USC § 102
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 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hewett (US 5110724 A).
With respect to claim 19, Hewett et al. teaches a method of monitoring the concentration of analyte in an individual's blood stream wherein the method (Column 7, line 30-32 teaches the final color reaction, from which concentration of analyte is determined, can be measured qualitatively by comparison with known color standards. Column 8, line 39-41 teaches as seen, the analytes may themselves be the substrate of the analyte-specific enzyme, as in the case of glucose, uric acid, amino acid oxidase, and free (non-esterified) cholesterol) comprises the steps of: a. obtaining a sample of blood (Column 7, line 23-25 teaches the user applies the blood sample to the dispenser and allows sample to migrate to the sample-transfer site);
b. transferring the blood sample to a sample collector (Column 3, line 37-40 teaches a sample dispenser 12 in the device generally includes a support 14 which defines a well 16 dimensioned and sized to receive a quantity of a blood sample. (Column 4, line 52-54 teaches a blood sample, typically 25-40 .µ.l, is introduced into well 16, from which it is drawn by tube 18 into matrix 22).
c. transferring the blood sample from the sample collector to a filter that is in communication with the sample collector, wherein the filter is configured to remove whole blood cells and solid materials from the blood sample to produce a residual blood serum (Column 8, line 52-53 teaches a blood sample, typically 25-40 .µ.l, is introduced into well 16, from which it is drawn by tube 18 into matrix 22. Column 8, line 54-55 teaches as the sample is drawn through the matrix by capillary flow, cellular components in the blood are retarded and the leading edge of the blood sample becomes progressively depleted of cell components). Column 5, line 13-17 teaches the filter means here acts to substantially completely remove blood cells and similar-size or larger particulate material in the blood sample as the sample migrates to the sample-distribution sites).
d. transferring a first portion of the residual blood serum to a test pad containing at least one analyte-detection reagent (Column 6, line 29-34 teaches during sample transfer, the sample in the dispenser will migrate into and through each pad. Column 9, line 58- 61 teaches the dispenser construction in the device allows for a small blood-sample volume to be distributed to multiple dispenser sites, with removal of blood cells as the sample migrates to the sites. Column 5, line 60-67 teaches when a serum sample reaches the sample-transfer sites in the dispenser, the test plate is moved toward its sample-transfer position , confronting surfaces of the pads are in contact with the corresponding transfer sites. At this position, sample fluid in the dispenser is drawn into the pads. Column 5, line 37-40 teaches each pad contains analyte-dependent reagents effective to produce an analyte-dependent change in the pad which can be detected optically, either visually or by a detector, in a known manner).
e. allowing the residual blood serum to react with the analyte-detection reagent for a predetermined period of time (Column 2, line 40-49 teaches a test plate in the device carries a plurality of wettable, absorbent assay pads, each having an exposed surface region and containing reagents for reacting with a selected analyte, when sample fluid is transferred to the pad, for analyte detection. The plate is mounted on the sample dispenser for movement toward and away from a sample-transfer position at which the surface regions of the pads are in contact with associated sample-transfer sites, for simultaneous transfer of cell-free sample fluid from the transfer sites to the assay pads. (Column 6, line 29-32) During sample transfer, the sample in the dispenser will migrate into and through each pad at a rate which causes the pad to become completely wetted over a given sample-transfer time. Column 6, line 62-66 teaches once the time required for optimal pad wetting has been measured, or calibrated, the apparatus may be operated for optimal sample-transfer by placing the device in a sample-transfer condition for the calibrated time period).
f. using an analyte sensor to quantify the concentration of analyte present in the residual blood serum from the reaction of the analyte with the analyte-detection reagent (Column 7, line 16-20 teaches based on the calculated volume of sample applied to a pad, and the amount of analyte contained in the volume, as determined by an analyte-dependent chemical reaction in the pad, the concentration of analyte in the sample can then be determined by the calculator).
g. displaying the detected analyte concentration as a numerical value or as a color patch on a display panel (Column 5, line 28-30 teaches the strip is transparent or has transparent windows which allow the pads to be viewed through the strip. Column 7, line 21-23 teaches alternatively, the assay device may be used for qualitative analyte determination, by visual determination of a test pad color intensity. Column 7, line 23-26 teaches typically, in this mode, the user applies the blood sample to the dispenser and allows sample to migrate to the sample-transfer sites in the dispenser, as judged visually. The test plate is then moved manually to the sample-transfer position, and held there briefly until the test pads have filled, again as judged visually by the change in translucence of the pads. The final color reaction, from which concentration of analyte is determined, can be measured qualitatively by comparison with known color standards
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 6, 8-13, 15-17 and are rejected under 35 U.S.C. 103 as being unpatentable over Hewett (US 5110724 A) in further view of Turner et al. (US 20120029830 A1) in further view of Braig et al. (US20090131861).
With respect to claim 1, Hewett et al. teaches A method of the concentration measuring of analyte and glucose in an individual's blood stream wherein the method (Column 7, line 30-32 teaches the final color reaction, from which concentration of analyte is determined, can be measured qualitatively by comparison with known color standards. Column 8, line 39-41 teaches as seen, the analytes may themselves be the substrate of the analyte-specific enzyme, as in the case of glucose, uric acid, amino acid oxidase, and free (non-esterified) cholesterol) comprises the steps of:
a. obtaining a sample of blood (Column 7, line 23-25 teaches the user applies the blood sample to the dispenser and allows sample to migrate to the sample-transfer site);
b. transferring the blood sample to a sample collector (Column 3, line 37-40 teaches a sample dispenser 12 in the device generally includes a support 14 which defines a well 16 dimensioned and sized to receive a quantity of a blood sample. (Column 4, line 52-54 teaches a blood sample, typically 25-40 .µ.l, is introduced into well 16, from which it is drawn by tube 18 into matrix 22).
c. transferring the blood sample from the sample collector to a filter that is in communication with the sample collector, wherein the filter is configured to remove whole blood cells and solid materials from the blood sample to produce a residual blood serum (Column 8, line 52-53 teaches a blood sample, typically 25-40 .µ.l, is introduced into well 16, from which it is drawn by tube 18 into matrix 22. Column 8, line 54-55 teaches as the sample is drawn through the matrix by capillary flow, cellular components in the blood are retarded and the leading edge of the blood sample becomes progressively depleted of cell components). Column 5, line 13-17 teaches the filter means here acts to substantially completely remove blood cells and similar-size or larger particulate material in the blood sample as the sample migrates to the sample-distribution sites).
d. transferring a first portion of the residual blood serum to a test pad containing at least one analyte-detection reagent (Column 6, line 29-34 teaches during sample transfer, the sample in the dispenser will migrate into and through each pad. Column 9, line 58- 61 teaches the dispenser construction in the device allows for a small blood-sample volume to be distributed to multiple dispenser sites, with removal of blood cells as the sample migrates to the sites. Column 5, line 60-67 teaches when a serum sample reaches the sample-transfer sites in the dispenser, the test plate is moved toward its sample-transfer position , confronting surfaces of the pads are in contact with the corresponding transfer sites. At this position, sample fluid in the dispenser is drawn into the pads. Column 5, line 37-40 teaches each pad contains analyte-dependent reagents effective to produce an analyte-dependent change in the pad which can be detected optically, either visually or by a detector, in a known manner).
e. allowing the residual blood serum to react with the analyte-detection reagent for a predetermined period of time (Column 2, line 40-49 teaches a test plate in the device carries a plurality of wettable, absorbent assay pads, each having an exposed surface region and containing reagents for reacting with a selected analyte, when sample fluid is transferred to the pad, for analyte detection. The plate is mounted on the sample dispenser for movement toward and away from a sample-transfer position at which the surface regions of the pads are in contact with associated sample-transfer sites, for simultaneous transfer of cell-free sample fluid from the transfer sites to the assay pads.
(Column 6, line 29-32) During sample transfer, the sample in the dispenser will migrate into and through each pad at a rate which causes the pad to become completely wetted over a given sample-transfer time. Column 6, line 62-66 teaches once the time required for optimal pad wetting has been measured, or calibrated, the apparatus may be operated for optimal sample-transfer by placing the device in a sample-transfer condition for the calibrated time period).
f. using an analyte sensor to quantify the concentration of analyte present in the residual blood serum from the reaction of the analyte with the analyte-detection reagent (Column 7, line 16-20 teaches based on the calculated volume of sample applied to a pad, and the amount of analyte contained in the volume, as determined by an analyte-dependent chemical reaction in the pad, the concentration of analyte in the sample can then be determined by the calculator).
g. displaying the detected analyte concentration as a numerical value or as a color patch on a display panel (Column 5, line 28-30 teaches the strip is transparent or has transparent windows which allow the pads to be viewed through the strip. Column 7, line 21-23 teaches alternatively, the assay device may be used for qualitative analyte determination, by visual determination of a test pad color intensity. Column 7, line 23-26 teaches typically, in this mode, the user applies the blood sample to the dispenser and allows sample to migrate to the sample-transfer sites in the dispenser, as judged visually. The test plate is then moved manually to the sample-transfer position, and held there briefly until the test pads have filled, again as judged visually by the change in translucence of the pads. The final color reaction, from which concentration of analyte is determined, can be measured qualitatively by comparison with known color standards).
i. allowing the residual blood serum to react on the test strip for a predetermined time ( Column 5, line 18-20 teaches a device 10 includes a test plate 44 composed of an elongate strip 46, and multiple wettable, absorbent test pads. Column 6, line 62-66 teaches once the time required for optimal pad wetting has been measured, or calibrated, the apparatus may be operated for optimal sample-transfer by placing the device in a sample-transfer condition for the calibrated time period).
However, Hewett et al. does not teach A. Method of monitoring., h. transferring a second portion of the residual blood serum to a glucose test strip, i. allowing the residual blood serum to react on the glucose test strip for a predetermined period of time; j. determining the concentration of glucose in the blood serum based on the reaction of the blood serum on the glucose test strip, wherein the glucose concentration is calibrated to generate a digital read-out that reflects the detected glucose concentration in the individual's blood stream; and k. displaying the detected glucose concentration as a numerical value on the display panel.
Turner et al. teaches testing blood glucose levels [0005]. Turner et al. teaches operating a lancet of the glucose testing device to penetrate the user's skin so that a quantity of blood exits a skin puncture caused by the lancet, transferring at least part of the quantity of blood to the test strip, and operating the glucose testing device to obtain data indicative of a blood glucose level from the quantity of blood [0016]. Turner et al. teaches An exemplary meter 10 operating as a blood glucose meter 10 of the present disclosure is configured, operable and/or adapted to accept a sample of blood for testing blood glucose level via a test strip 80 as shown in FIG. 2B [0040].
Turner et al. teaches A. Method of monitoring ( [0032] teaches the present invention is a blood glucose test/testing meter or monitor for ascertaining blood glucose level from a sample of blood. [0057] teaches for example, and in an exemplary embodiment of a meter 10 of the present disclosure, meter 10 is operable to store up to ninety-nine (99) tests in memory 53 to provide seven (7), fourteen (14) or thirty (30) day blood glucose level averages. [0059] teaches for examples, meters 10 for use with testing blood glucose levels, but said meters 10 may be used to test various other chemical levels within a bodily fluid, and may be used with one or more other types of test strips to that a user may check for the presence and/or levels of a particular chemical within a bodily fluid.),
H. transferring a second portion of the residual blood serum to a glucose test strip([0032] The present invention is a blood glucose test/testing meter or monitor for ascertaining blood glucose level from a sample of blood that is the size of a standard credit card and which incorporates a replaceable blood glucose test strip cartridge that holds a plurality of blood glucose test strips. [0051] Test strip 80 is inserted into test opening 18 of meter 10 either before or after lancet 68 pierces the skin, and the drop of blood is then deposited onto test strip 80. Column 2, lines 22-25 teaches the sample is taken up into multiple absorbent pads. Column 6 line 44-45 teaches during sample transfer, as liquid sample migrates into and through a pad. Column 6 line 58 teaches each pad wetted completely at about the same rate. Column 9 line 58-61 teaches the dispenser construction in the device allows for a small blood-sample volume to be distributed to multiple dispenser sites, with removal of blood cells as the sample migrates to the sites).
i. allowing the residual blood serum to react on the glucose test strip ([0002] teaches such meters are operable by providing a blood glucose test strip having a reagent thereon, whereby the reagent reacts with a sample of blood, either blood plasma or blood serum, deposited thereon that is then read by the blood glucose meter to ascertain a blood glucose level.)
j. determining the concentration of glucose in the blood serum based on the reaction of the blood serum on the glucose test strip, wherein the glucose concentration is calibrated to generate a digital read-out that reflects the detected glucose concentration in the individual's blood stream and k. displaying the detected glucose concentration as a numerical value on the display panel. ([0041] teaches test strip acceptance and reading area 54 utilizes known blood glucose testing and reading hardware, processes and methods to obtain a blood glucose level (reading) from the blood sample on test strip 80. [0002] teaches such meters are operable by providing a blood glucose test strip having a reagent thereon, whereby the reagent reacts with a sample of blood (blood plasma or blood serum) deposited thereon that is then read by the blood glucose meter to ascertain a blood glucose level. [0037] teaches various displays 20 of the present disclosure are capable of showing date, time, blood glucose level(s) in either mg/dL or mmol/L, and/or blood glucose level averages in either mg/dL or mmol/L.
[0014] teaches the circuit board comprising a test strip acceptance and reading area capable of receiving at least part of a test strip and producing the data indicative of a test strip fluid from the test strip, a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board. [0051] teaches a drop of blood could also be obtained prior to insertion of test strip 80 into test opening 18 of meter 10. The test strip acceptance and reading area 54 of circuit board 50 then reads/processes the test strip 80 to obtain strip data and provides same to the processor 52. )
Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filing date of the instant invention to modify method of measuring the concentration of analyte and glucose in an individual's blood stream of Hewett to incorporate the teachings of a blood glucose test/testing meter or monitor for ascertaining blood glucose level from a sample of blood where a drop of blood is then deposited onto blood glucose test strip with a reagent that reacts with a sample of blood serum, read by the blood glucose meter to determine the blood glucose level and displayed as the concentration as taught by Turner et al. [0032] to provide: A. Method of monitoring, H. transferring a blood serum to a glucose test strip, i. allowing the residual blood serum to react on the glucose test strip, j. determining the concentration of glucose in the blood serum based on the reaction of the blood serum on the glucose test strip, wherein the glucose concentration is calibrated to generate a digital read-out that reflects the detected glucose concentration in the individual's blood stream and k. displaying the detected glucose concentration as a numerical value on the display panel. It would
have been obvious to make the modification because Hewett teaches an assay device with multiple test pads designed to detect multiple analytes from a drop of blood and Turner et al. teaches a device that contains meters 10 that may be used to test glucose or various other chemical levels within a bodily fluid, and may be used to check for the presence and/or levels of a particular chemical within a bodily fluid. Doing so would have a reasonable expectation of successfully in determining the concentrations of analytes such as glucose by Hewett et al. (Column 7: line 44-45). See MPEP 2143 (I)(D). The person of ordinarily skill in the art would further have predicted that the modification would allow for blood glucose level averages to be stored for seven (7), fourteen (14) or thirty (30) day [0057].
With respect to claim 2, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Hewett further teaches wherein analyte-detection reagent changes color in the presence of a predetermined analyte (Hewett, Column 8, line 18-22 teaches when sample fluid is introduced into this first pad, the reference compound is brought into solution and into contact with the oxidase enzyme, with the generation of H.sub.2 O.sub.2 and H.sub.2 O.sub.2 -dependent generation of colored reaction product. Column 8, line 22-24 teaches the intensity of the colored reaction product will depend (i) the amount of known reference compound in the pad which is known).
With respect to claim 3, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Hewett teaches wherein the predetermined period of time to produce an analyte complex is defined as a point when a color change differential is below a predetermined value (Hewett, Column 6, line 67-Column 7, line 1-3 teaches the detector is also used measure the change in reflectance in the associated pad due to the production of a colored reaction product in the pad, as analyte is utilized in forming the reaction product, after pad wetting occurs. Column 7, line 3-9 teaches as can be appreciated, when the light beam of the light source has a wavelength at or near the absorption maximum of the colored reaction product, the reflectance from the pad will decrease gradually with continued production of reaction product, until a new (second) reflectance-curve plateau is reached at the end point of the reaction. Column 7, line 9-12 teaches the total amount of analyte can then be calculated from the difference in reflectance at the first plateau (just after pad wetting) and at the second plateau (at the product end point). Column 7, line 12-15 teaches alternatively, the amount of analyte can be calculated from reaction kinetics, based on the rate of change of reflectance observed after pad wetting. Column 6, line 62-66 teaches once the time required for optimal pad wetting has been measured, or calibrated, the apparatus may be operated for optimal sample-transfer by placing the device in a sample-transfer condition for the calibrated time period).
With respect to claim 6, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1. Hewett further teaches wherein the sample of blood is less than or equal to 0.1 mL (Hewett, Column 2, line 8-12 teaches (b) employs a single drop of whole blood, typically less than 50 µ.l).
With respect to claim 8, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1. Hewett et al. further teaches wherein in step (c) the blood sample transfers to the filter via capillary action (Hewett, Column 4, line 52-54 teaches in operation, a blood sample, typically 25-40 .µ.l, is introduced into well 16, from which it is drawn by tube 18 into matrix 22. Column 4, line 54-58 teaches as the sample is drawn through the matrix by capillary flow, cellular components in the blood are retarded and the leading edge of the blood sample becomes progressively depleted of cell components. Column 4, line 58-62 teaches the reduced concentration of the blood cells of the sample material which reaches membrane 24 reduces the tendency of the membrane to clog as sample material is drawn though the membrane by capillary flow into strip 26. After passage through membrane 24, the sample is essentially a cell-free plasma fluid which is then drawn toward the sample-transfer regions at the opposite end regions of the strip.).
With respect to claim 9, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1. Hewett et al. further teaches wherein in step (d) the residual blood serum transfers to the test pad via capillary action (Column 5, line 60-64 teaches in operation, when a serum sample reaches the sample-transfer sites in the dispenser, the test plate is moved toward its sample-transfer position (FIG. 4), at which the exposed, confronting surfaces of the pads are in contact with the corresponding transfer sites. Column 5, line 64-67 teaches at this position, sample fluid in the dispenser is drawn into the pads by capillary flow with fluid movement occurring in a direction normal to the pad surfaces).
With respect to claim 10, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Hewett further teaches wherein in step (j), the glucose concentration is measured with a glucometer. (Turner et al, [0040] teaches an exemplary meter 10 operating as a blood glucose meter 10 of the present disclosure is configured, operable and/or adapted to accept a sample of blood for testing blood glucose level via a test strip 80 as shown in FIG. 2B).
With respect to claim 11, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 1.
Hewett teaches the detector may be coupled to a microprocessor designed to calculate total sample volume transfer to each pad, as described in the above-mentioned co-pending patent application, Ser. No. 320,474 (Column 6, line 59-62). Hewett teaches the strip is transparent or has transparent windows which allow the pads to be viewed through the strip (Column 5, line 28-29). Hewett teaches the detector is also used measure the change in reflectance in the associated pad due to the production of a colored reaction product in the pad, as analyte is utilized in forming the reaction product, after pad wetting occurs (Column 6, line 67-Column 7, line 3). Hewett teaches the total amount of analyte can then be calculated from the difference in reflectance at the first plateau (just after pad wetting) and at the second plateau (at the product end point) (Column 7, line 9-12). Hewett teaches alternatively, the amount of analyte can be calculated from reaction kinetics, based on the rate of change of reflectance observed after pad wetting (Column 7, line 12-15). Hewett teaches based on the calculated volume of sample applied to a pad, and the amount of analyte contained in the volume, as determined by an analyte-dependent chemical reaction in the pad, the concentration of analyte in the sample can then be determined by the calculator (Column 7, line 16-20).
Hewett does not teach wherein the numerical value is displayed on a mobile smart phone, tablet, computer, notepad, IoT hub, connected devices that are Blue Tooth capable or BLE capable, or a combination thereof.
Turner et al. teaches testing blood glucose levels [0005]. Turner et al. teaches operating a lancet of the glucose testing device to penetrate the user's skin so that a quantity of blood exits a skin puncture caused by the lancet, transferring at least part of the quantity of blood to the test strip, and operating the glucose testing device to obtain data indicative of a blood glucose level from the quantity of blood [0016]. Turner et al. teaches an exemplary meter 10 operating as a blood glucose meter 10 of the present disclosure is configured, operable and/or adapted to accept a sample of blood for testing blood glucose level via a test strip 80 as shown in FIG. 2B [0040].
Turner et al. teaches [0058] teaches a processor 52 (and/or another component of meter 10) may incorporate a wireless communications protocol that allows the wireless transmission of data to and/or from meter 10. The wireless communications protocol may also allow the reception of incoming wireless signals. [0037] teaches various displays 20 of the present disclosure are capable of showing date, time, blood glucose level(s) in either mg/dL or mmol/L, and/or blood glucose level averages in either mg/dL or mmol/L. Turner et al. teaches a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board, the processor capable of receiving and processing the data from the circuit board, a memory device operably coupled to the processor, the memory device capable of receiving and storing data from the circuit board and a display operably coupled to the processor, the display capable of displaying a processed blood glucose level result indicative of the data on a screen [0015]. [0051] teaches data transfer mechanism 75 comprises a USB port, and in at least another embodiment, data transfer mechanism 75 comprises a wireless transfer device. [0012] teaches the device further comprises a data transfer mechanism operably coupled to the processor or a memory coupled thereto, the data transfer mechanism capable of transferring the data from the device to an external computer.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filing date of the instant invention to modify method of using a microprocessor designed to calculate total sample volume transfer to each pad of Modified Hewett to incorporate the teachings of a processor 52 (that allows for wireless communications as taught by Turner et al [0058] to provide: wherein the numerical value is displayed on a mobile smart phone, tablet, computer, notepad, IoT hub, connected devices that are Blue Tooth capable or BLE capable, or a combination thereof. Doing so would have a reasonable expectation of successfully in calculating and determining the concentration of glucose by Hewett (Column 7: line 44-45). See MPEP 2143 (I)(D). It would have been obvious to make the modification because Hewett teaches the detector may be coupled to a microprocessor designed to calculate total sample volume transfer to each pad where the total amount of analyte can then be calculated from the difference in reflectance just after pad wetting and at the product end point plateaus and the amount of analyte can be calculated from reaction kinetics and Turner et al. teaches circuit board 50 then reads/processes the test strip 80 to obtain strip data and provides same to the processor 52 which is coupled to memory. The person of ordinarily skill in the art would further have predicted that using a processor with wireless communications ability would allow meter 10 to be connected to an external device for the downloading and/or uploading of meter data, and/or to allow the uploading of meter programming if desired [0058].
With respect to claim 12, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Hewett teaches the total amount of analyte can then be calculated from the difference in reflectance at the first plateau (just after pad wetting) and at the second plateau (at the product end point) (Column 7, line 9-12). Hewett teaches alternatively, the amount of analyte can be calculated from reaction kinetics, based on the rate of change of reflectance observed after pad wetting (Column 7, line 12-15). Hewett teaches based on the calculated volume of sample applied to a pad, and the amount of analyte contained in the volume, as determined by an analyte-dependent chemical reaction in the pad, the concentration of analyte in the sample can then be determined by the calculator (Column 7, line 16-20).
Modified Hewett does not teach further including a step I) wherein the analyte concentration values and the glucose concentration values are electronically transferred to a data storage base.
Turner et al. teaches testing blood glucose levels [0005]. Turner et al. teaches operating a lancet of the glucose testing device to penetrate the user's skin so that a quantity of blood exits a skin puncture caused by the lancet, transferring at least part of the quantity of blood to the test strip, and operating the glucose testing device to obtain data indicative of a blood glucose level from the quantity of blood [0016]. Turner et al. teaches an exemplary meter 10 operating as a blood glucose meter 10 of the present disclosure is configured, operable and/or adapted to accept a sample of blood for testing blood glucose level via a test strip 80 as shown in FIG. 2B [0040].
Turner et al. teaches further including a step I) wherein the analyte concentration values and the glucose concentration values are electronically transferred to a data storage base (Turner et al., [0015] teaches a processor operably coupled to the circuit board, the processor capable of receiving and processing the data from the circuit board, the processor capable of receiving and processing the data from the circuit board, a memory device operably coupled to the processor, the memory device capable of receiving and storing data from the circuit board and a display operably coupled to the processor, the display capable of displaying a processed blood glucose level result indicative of the data on a screen. [0051] teaches memory 53 is provided within meter 10 and is operably coupled to processor 52 so that strip data from processor 52 may be stored within memory 53 as needed/desired. [0059] teaches as referenced herein, various embodiments of meters 10 are provided and described. The scope of the present disclosure includes, for examples, meters 10 for use with testing blood glucose levels, but said meters 10 may be used to test various other chemical levels within a bodily fluid, and may be used with one or more other types of test strips to that a user may check for the presence and/or levels of a particular chemical within a bodily fluid).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filing date of the instant invention to modify method of calculating the amount of analyte using a microprocessor of Hewett et al. to incorporate the teachings of a memory 53 is provided within meter 10 and is operably coupled to processor 52 so that strip data from processor 52 may be stored within memory 53 as needed/desired as taught by Turner et al. [0051] to provide: further including a step I) wherein the analyte concentration values and the glucose concentration values are electronically transferred to a data storage base. It would have been obvious to make the modification because Hewett teaches using a microprocessor for calculating amount of analyte and glucose and Turner et al. teaches monitoring the concentration of glucose. See MPEP 2143 (I)(D). The person of ordinarily skill in the art would further have predicted that the modification would allow for blood glucose level averages to be stored for seven (7), fourteen (14) or thirty (30) day [0057].
With respect to claim 13, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Hewett et al. teaches wherein more than one analyte is detected (Hewett, Column 9 line 48-51 teaches the assay device provides accurate analyte determination of multiple blood analytes present from a single drop of whole blood).
With respect to claim 15, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 13. Modified Hewett teaches wherein a plurality of test pads are provided and each test pad comprises one analyte-detection reagent (Hewett, Column 5, line 30-33 teaches in the present embodiment, the device includes four sample-transfer sites and four associated pads. Hewett, Column 5, line 34-37 teaches more generally, the device includes at least two and up to six or more pads and sample-transfer sites. Hewett, Column 5, line 37-40 teaches each pad contains analyte-dependent reagents effective to produce an analyte-dependent change in the pad which can be detected optically, either visually or by a detector, in a known manner).
With respect to claim 16, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1. Hewett teaches wherein the test pad further includes a color change indicator (Hewett, Column 7, line 48-51 teaches the test pads each contain common-pathway reagent components for converting H.sub.2 O.sub.2 to a distinctly colored signal reaction product. Column 7, line 51-52 teaches the components include peroxidase, and a dye, meaning a single dye or coupled dye system).
With respect to claim 17, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 16.
Modified Hewett et al. teaches wherein the color change indicator is selected from indophenol, 7-(n-decyl)-2,-methyl-4-(3′,5′-dichlorophen-4′-one)indophenol, triphenylmethanes, tetrabromo-phenolphthalein decyl ester (TBDE), 2-methyl-4-(3′,5′-dichlorophen-4′-one)indonaphth-I-ol, fluoresceins, methyl(tetrabromo fluorescein), fluorescein esters, 5 7-hydroxy coumarins, resorufins, pyren-3-ols, flavones, phenolphthalein, bromocresol purple, cresophthalein, chlorophenol red, tetrabromophenol blue, thymophthalein, eosin-5-maleamic acid, or a combination thereof (Hewett, Column 7, line 48-54 teaches the test pads each contain common-pathway reagent components for converting H.sub.2 O.sub.2 to a distinctly colored signal reaction product. Column 7, line 51-54 teaches the components include peroxidase, and a dye, meaning a single dye or coupled dye system, is converted by the peroxidase, in the presence of H.sub.2 O.sub.2, to a distinctively colored, signal reaction product. Column 7, line 61-62 teaches he specificity of the enzyme for the donor is generally low, and a number of phenols, aminophenols, diamines, and indolephenols are active).
).
Claim 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hewett (US 5110724 A) in further view of Turner et al. (US 20120029830 A1) in further view of Braig et al. (US20090131861) as applied to claim 1 above, and further in view of Fuisz (20150002297 A1).
With respect to claim 4, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Hewett et al. teaches each pad contains analyte-dependent reagents effective to produce an analyte-dependent change in the pad which can be detected optically, either visually or by a detector (Column 5, line 37-40). Modified Hewett et al. teaches the detector is also used measure the change in reflectance in the associated pad due to the production of a colored reaction product in the pad, as analyte is utilized in forming the reaction product, after pad wetting occurs (Hewett, Column 6, line 67-Column 7, line 1-3). Modified Hewett et al. teaches table I shows several exemplary analytes (Column 8, line 36).
Modified Hewett et al. does not teach wherein the analyte measured is sodium ion or potassium ion or a combination thereof.
Fuisz teaches providing a medical analyzer with at least one threshold value for the at least one analyte to be sensed by the medical analyzer, sensing the analyte level [0007]. Fuisz teaches providing a medical analyzer with at least one threshold value for the at least one analyte to be sensed by the medical analyzer, sensing the analyte level [0007]. Teaches measuring and monitoring the concentration of potassium [041]. Fuisz teaches producing a readout of results and the processor 2 may be resident on the analyzer (and may be the same processor as or a separate processor from the processor performing the analyzer functions) or may be provided separately therefrom. Fuisz teaches if provided separately, the processor 2 may be connected to the analyzer in any way that allows transfer of data from the analyzer to the processor, and the connection can be a wired connection, a wireless connection, a LAN connection, the Internet, etc [0036]
Fuisz further teaches wherein the analyte measured is sodium ion or potassium ion or a combination thereof ([0038] teaches a sequential multiple analysis comprehensive blood test displaying a panel of analytes).
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Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filing date of the instant invention to modify the plurality of analytes measured of Modified Hewett to incorporate the teachings of measuring the concentration of sodium and potassium within the tissue fluid as taught by Fuisz. [0038] to provide: wherein the analyte measured is sodium ion or potassium ion or a combination thereof. Doing so would have a reasonable expectation of successfully of measuring multiple analytes by Modified Hewett (Coulmn 2, line 19). It would have been obvious to make the modification because Hewett teaches the test device may contain more than three or four test pads for testing multiple analytes and other analyte tests can be added and Fuisz teaches analyzers that measure bodily fluid and all measurements of metabolic and physiologic indicia or other analytes. See MPEP 2143 (I)(D). The person of ordinary skill of the art would have known that a physician can monitor the patient using the home analyzer [0042].
With respect to claim 18, modified Hewett teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Hewett teaches test strip acceptance and reading area 54 utilizes known blood glucose testing and reading hardware, processes and methods to obtain a blood glucose level (reading) from the blood sample on test strip 80 (Turner et al., [0041]). Modified Hewett teaches such meters are operable by providing a blood glucose test strip having a reagent thereon, whereby the reagent reacts with a sample of blood (blood plasma or blood serum) deposited thereon that is then read by the blood glucose meter to ascertain a blood glucose level (Turner et al., [0002]). Modified Hewett teaches various displays 20 of the present disclosure are capable of showing date, time, blood glucose level(s) in either mg/dL or mmol/L, and/or blood glucose level averages in either mg/dL or mmol/L (Turner et al., [0037].
Modified Hewett et al. does not teach wherein the analyte concentration is displayed as mEq/L units.
Fuisz teaches providing a medical analyzer with at least one threshold value for the at least one analyte to be sensed by the medical analyzer, sensing the analyte level [0007]. Teaches measuring and monitoring the concentration of potassium [041]. Fuisz teaches producing a readout of results and the processor 2 may be resident on the analyzer (and may be the same processor as or a separate processor from the processor performing the analyzer functions) or may be provided separately therefrom. Fuisz teaches if provided separately, the processor 2 may be connected to the analyzer in any way that allows transfer of data from the analyzer to the processor, and the connection can be a wired connection, a wireless connection, a LAN connection, the Internet, etc [0036]
Fuisz teaches wherein the analyte concentration is displayed as mEq/L units [0038, image below].
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Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filing date of the instant invention to modify method of displaying blood glucose level(s) in either mg/dL or mmol/L, and/or blood glucose level averages in either mg/dL or mmol/L of Modified Hewett to incorporate the teachings of analyte concentration is displayed as mEq/L units as taught by Fuisz [0038] to provide: wherein the analyte concentration is displayed as mEq/L units. It would
have been obvious to make the modification because Modified Hewett teaches displaying the concentration of analytes and Fuisz et al. teaches a metabolic panel. Doing so would have a reasonable expectation of successfully in displaying the concentration of analyte by Modified Hewett [0037]. See MPEP 2143 (I)(D).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hewett (US 5110724 A) in further view of Turner et al. (US 20120029830 A1) in further view of Braig et al. (US20090131861) as applied to claim 1 above, and further in view of Chu et al. (US 6190918 B1).
With respect to claim 5, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Hewett et al. teaches the test pads each contain common-pathway reagent components for converting H2O2 to a distinctly colored signal reaction product (Hewett, Column 7, line 48-51). Modified Hewett et al. teaches the components include peroxidase, and a dye, meaning a single dye or coupled dye system (Column 7, line 51-52). Modified Hewett et al. teaches the remaining test pads contain reagent components effective to generate H.sub.2 O.sub.2 by reaction with selected analytes, including an oxidase enzyme which is specific for the selected substrate (Column 8, line 33-37). Modified Hewett et al. teaches alternatively, the analyte may be first converted by primary analyte-specific enzyme(s) to produce the substrate recognized by the oxidase enzyme (Column 8, line 44-46). Here the analyte-specific oxidase reagents include both the oxidase and additional enzyme for converting the analyte to the oxidase substrate (Column 8, line 46-49).
Modified Hewett et al. does not teach wherein the analyte-detection reagent is selected from beta-galactosidase, adenosine triphosphatase, or a combination thereof.
Chu et al. teaches a device and a process for detecting an analytes in a biological fluid in a multilayer reagent system (Chu et al. teaches a multilayer reagent system device for detection of analyte in a biological fluid (Column 3, line 4-5). Chu et al. teaches In one preferred aspect, the present invention contemplates a device for detecting glucose in a biological fluid sample, which device comprises a separation matrix and a means for detecting glucose (Column 3 line 31-36). Chu et al. teaches separation matrix can further contain a substance that interacts with an applied sample so long as that substance does not adversely affect detection of an analyte (Column 5 line 50-52). Chu et al. teaches by way of example, where a biological fluid is blood, and means for detecting glucose is a calorimetric means, the presence of red blood cells would likely interfere with color detection (Column 5, line 57-60). Red blood cells can be aggregated in a separation matrix such that those cells do not migrate to a detection means and interfere with color detection (Column 5 line 60-62).
Chu et al. teaches wherein the analyte-detection reagent is selected from beta-galactosidase, adenosine triphosphatase, or a combination thereof (Column 4, line 43-44 teaches chemical reagents used for detecting analytes are well known in the art. Column 4, line 44-46 teaches In a preferred embodiment, such chemical reagents interact with analyte to generate a change in color (e.g., a colorimetric assay of analyte. Column 4, line 46-48 teaches a preferred embodiment, where the analyte is glucose, chemical reagents used for the colorimetric detection of glucose are those used in the well-known hexokinase reaction. Column 4, line 48-50 teaches the chemical reactions and reagents involved in that reaction are set forth below. Column 4, line 61-64 teaches in accordance with that embodiment, a device of the present invention comprises a detection matrix that contains the substrates, enzymes and indicators needed for the hexokinase detection of glucose. Column 4, line 64-67 teaches those reagents comprise adenosine triphosphate).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the
effective filing date of the instant invention to modify common-pathway reagents of Modified Hewett to incorporate the teachings of reagents that comprise adenosine triphosphate as taught by Chu et al. [0105] to provide: wherein the analyte-detection reagent is selected from beta-galactosidase, adenosine triphosphatase, or a combination thereof. It would have been obvious to make the modification because Modified Hewett teaches the test pads each contain common-pathway reagent components which produce distinctly colored signal reaction product and Chu et al. teaches chemical reagents that interact with analyte to generate a change in color. Doing so would have a reasonable expectation of successfully of reacting the analyte with a reagent to detect the concentration of analyte by Modified Hewett (Coulmn 10, line 13-15). See MPEP 2143 (I)(D).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hewett (US 5110724 A) in further view of Turner et al. (US 20120029830 A1) in further view of Braig et al. (US20090131861) as applied to claim 1 above, and further in view of Burd et al. (US 20090088336 A1).
With respect to claim 7, modified Hewett et al. teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Hewett et al. teaches the assay device provides accurate analyte determination of multiple blood analytes present from a single drop of whole blood, typically less than 40-50 .mu.l volume (Column 9, line 48-52). Secondly, the device acts to separate blood cells from blood fluid, to eliminate color and other cell-related interference with the assay (Column 9, line 52-54). Thirdly, the volume of sample which is transferred to the test pads can be controlled by controlling sample-transfer time (Column 9, line 54-56).
Modified Hewett et al. does not teach wherein in step (b) the sample collector absorbs a non-dosed amount of blood.
Burd et al. teaches a cartridge is disclosed for automated detection of an analyte in a bodily fluid sample comprising: an array of addressable assay units configured to run a chemical reaction that yields a detectable signal indicative of the presence or absence of the analyte [0009]. Burd et al. teaches a sample collection unit configured to receive the bodily fluid sample; an array of assay units configured to receive a portion of the sample from the sample collection [0010]. Burd et al. teaches the bodily fluid sample can be a blood sample [0012]. Burd et al teaches a fluid transfer device can be a pipette and can be automated [0014].
Burd et al. teach wherein in step (b) the sample collector absorbs a non-dosed amount of blood.
([0105] teaches in an embodiment, the user applies a sample such as a measured or an unmeasured blood sample to the device and inserts the device into the instrument [0105]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant invention to modify method of depositing a single drop of whole blood, typically less than 40-50 .mu.l of Modified Hewett to incorporate the teachings of a measured or an unmeasured blood sample) to the device as taught by Burd [0105] to provide: wherein in step (b) the sample collector absorbs a non-dosed amount of blood. It would have been obvious to make the modification because Modified Hewett teaches a assay device where a single drop of whole blood is applied and Burd et al. teaches the user applies a measured or an unmeasured blood sample to the POC device . Doing so would have a reasonable expectation of successfully in applying the blood to a device be analyzed by Modified Hewett (Column 7, line 23). See MPEP 2143 (I)(D).
Conclusion
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/S.J.B./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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