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 .
Response to Arguments
Applicant’s arguments, see Remarks , filed 6/1/2026, with respect to rejection of claims 18-22 and 28-35 under 35 USC 112 2nd paragraph have been fully considered and are persuasive. The rejection of claims 18-22 and 28-35 under 35 USC 112 has been withdrawn.
Applicant’s arguments with respect to claim(s) 18-22 and 28-35 have been considered but are moot in view of the new grounds of rejection. Note newly cited references to of Miller et al.( US 11540751) and Koehler et al.( US 20160119210) as set forth below.
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.
Claim(s) 18-22, 29, and 31-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leabman(US 20200193326 ) hereinafter Leabman in view of Miller et al.( US 11540751) hereinafter Miller et al. and further in view of Koehler et al.( US 20160119210) hereinafter Koehler et al .
Regarding claims 18 – 19 and 39-41, Leabman teaches Leabman teaches a wearable sensing device 100 that is configured to be worn by a user (see Leabman, par 0068-0069, figs. 1A-1B & 4A-4D) comprising:
a non-invasive analyte sensor 110, 510 (i.e., a sensor system used for glucose monitoring of a user using millimeter range radio waves) (see Leabman, par 0068, 0072 & 0075, fig. 1B & 4B-4D) that is configured to non-invasively detect an analyte of the user (i.e., glucose) (see Leabman, par 0068, 0072 & 0075), the non-invasive analyte sensor includes:
at least one transmit antenna 544 and at least one receive antenna 546, the at least one transmit antenna is positioned and arranged to transmit a signal into the user, wherein the signal is in a radio or microwave frequency range of the electromagnetic spectrum, and the at least one receive antenna is positioned and arranged to detect a response resulting from transmission of the signal by the at least one transmit antenna into the user (see Leabman, par 0063, 0068, 0075-0076, fig. 5);
wherein the wearable sensing device 100 is configured to detect two or three or more of user temperature, user heart rate, user oxygen saturation, user blood pressure, user activity, user sleep (i.e., the smartwatch detects user heart rate and user blood pressure) (see Leabman, par 0124, 0130, 0133, 0143, 0145), and an additional analyte of a user (i.e., the smartwatch detects analytes such as glucose, alcohol, narcotics, or cannabis) (see Leabman, par 0124).
Leabman does not specifically teach the wearable sensing device includes at least one rechargeable battery that provides electrical power to power operation of the wearable sensing device or indicate, on the wearable sensing device, teach the wearable sensing device comprises a second sensor that detects the two or three or more additional data parameters that are received by the wearable sensing device, a determined correlation between changes in the analyte data and changes in the data detected by the second sensor during the sensing period, and based on the determined correlation, provide an instruction to the user to engage in an activity that causes a change in a level of the analyte.
Miller et al. teaches in the same field of endeavor a health device network may include: a non-invasive glucometer including a rechargeable battery ( paragraph 52) that non-invasively measures analyte levels; an invasive glucometer communicatively coupled directly to the non-invasive glucometer; a cloud-based server communicatively coupled to the non-invasive glucometer or the invasive glucometer; a user device communicatively coupled to the cloud-based server; and/or a user interface that displays the invasive glucose measurement, the non-invasive glucose measurement, a data batch, and/or processed data to the user. The non-invasive glucometer and/or the invasive glucometer may aggregate an invasive glucose measurement and a non-invasive glucose measurement (paragraph (50) teaches a number of additional second sensor measurements including temperature, heart rate, etc) into the data batch. A data analytics application on the cloud-based server may be configured to: integrate the invasive glucose measurement and the non-invasive glucose measurement; identify a correlation between the invasive glucose measurement and the non-invasive glucose measurement; and/or generate a predictive model based on the invasive glucose measurement and the non-invasive glucose measurement. Paragraph (236), The set of data elements may include data indicative of an adverse symptom experienced by the subject during the time interval. The individual data element may include a trend in a set of the second non-invasive analyte measurement reading. Prompting the subject may be triggered by identifying the trend.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Leabman a rechargeable battery and where the wearable sensing device comprises a second or more sensor(s) that detects the two or three or more additional data parameters that are received by the wearable sensing device and data analytics to correlate the analyte and non-analyte data to identify trends and a prompt to the user regarding measured trends based on the analyte and non-analyte correlation data as taught by Miller to help the user better manage the user’s health.
Leabman as modified by Miller et al. teaches correlating analyte and non-analyte measurements of a user and correlating the data and prompting or notifying the user to take some action. It is the interpretation of the examiner that broadly, an “activity” that causes a “level of the analyte to change” could be prompting the user to take a new measurement or recalibrate the device which could result in a different or change in the analyte level.
However Leabman as modified by Miller et al. as set forth above does not specifically teach provide an instruction to the user to engage in an activity that causes a change in a level of the analyte.
Koehler et al. teaches in the same field of endeavor methods for presenting glucose level data. Glucose data for a patient may be received. A current glucose level and a rate of change of the current glucose level may be determined based on the received glucose data. A first interface may be displayed on a screen of a device. The first interface may include a unitary icon. The unitary icon may display the current glucose level and a visualization of the rate of change. Paragraph [0203] FIG. 8B, the application may apply a yellow color scheme 1720 to indicate that the patient may be in danger of becoming hyperglycemic. In some implementations, application 255 may apply a red color scheme 1710 for a high-risk situation, a yellow color scheme 1720 for a moderate risk situation, and no shading or a grey shading for a relatively low risk situation. The shading on the screen may discreetly prompt the patient or remote monitor to take action to raise or lower the patient's glucose level as needed.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Leabman as modified by Miller et al. a display and prompt for the user to take an action to raise or lower the user’s glucose or analyte level as taught by Koehler et al. to help the user better manage their health and avoid high risk health situations.
Regarding claims 20-21, 29, and 31, Leabman as modified by Miller et al. teaches wherein the second sensor is configured to detect during the sensing period, four or more of user temperature, user heart rate, user oxygen saturation, user blood pressure, user activity, user sleep, and the additional analyte and wherein the analyte detected by the non-invasive analyte sensor includes blood glucose of the user.
Miller et al paragraph (50) and paragraph (92)-(93), In one embodiment, the first sensor 112 may include a miniaturized spectrometer. In another embodiment, the second sensor 114 may include a miniaturized impedance sensor. In another embodiment, the first sensor 112 and/or the second sensor may include a temperature sensor, a viscosity sensor, an ultrasonic sensor, a humidity sensor, a heart rate sensor, a dietary intake sensor, an electrocardiogram (EKG) sensor, a galvanic skin response sensor, a pulse oximeter, an optical sensor, and blood pressure as set forth in paragraph (92).
Regarding claim 22, Leabman as modified by Miller et al. teaches wherein the wearable sensing device comprises a watch with a wristband. Both Leabman and Miller et al. are embodied as a wristwatch with a wristband.
Regarding claims 32-33 Leabman does not specifically teach wherein the correlation between the detected analyte and the data detected by the second sensor is determined by the wearable sensing device or wherein the correlation between the detected analyte and the data detected by the second sensor is determined by a separate server.
Miller et al. teaches (95) The wearable device 100 may correlate the raw data and/or the physiological characteristics from the peripheral measurement device(s) 304 with raw data and/or physiological characteristics measured by the wearable device 100. (49) The processing device 102 and/or the processing unit 110 may provide an output based on an input. In an embodiment, the processing device 102 and/or the processing unit 110 may include a central processing unit, a graphics processing unit, a vision processing unit, a tensor processing unit, a neural processing unit, a physics processing unit, a digital signal processor, an image signal processor, a synergistic processing element, a field-programmable gate array, a sound chip, a microprocessor, a multi-core processor, and so forth. (97) The invasive analyte measurement device 302 may correlate the raw data and/or the physiological characteristics from the peripheral measurement device(s) 304 with raw data and/or physiological characteristics measured by the wearable device 100. Abstract: A data analytics application on the cloud-based server may be configured to: integrate the invasive glucose measurement and the non-invasive glucose measurement; identify a correlation between the invasive glucose measurement and the non-invasive glucose measurement; and/or generate a predictive model based on the invasive glucose measurement and the non-invasive glucose measurement.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Leabman where the data analytics and correlation is done either on the watch itself or an external device or a server as taught by Miller et al. as a matter of design choice and to allow flexibility in data analysis and resource management.
Regarding claims 34-35, and 42 Leabman as modified by Miller et al. and Koehler et al. teaches wherein the sensing period is equal to or greater than 1 hour or wherein the sensing period is equal to or greater than 8 hours or 24 hours. Paragraphs (122),(156), (193), (212) of miller et al. the wearable device 100 and the invasive analyte measurement device 302 may take separate measurements approximately concurrently, where approximately concurrent may refer to measurements taken simultaneously and/or within a time period of each other, the time period less than a time period of change for a respective analyte. Miller et al. (193) The time period 512 may include a fixed time period, such as a current day, and hour, a week, a month, and so on. The graph 500 may display the time period 512 and may show analyte measurements as the analyte measurements are taken, indexed to the time during the day the measurements are taken. A user may view the graph at 8:00 am and see measurements taken between 12:00 am and 8:00 am. The user may review the graph at 10:00 am and see measurements taken between 12:00 am and 10:00 am, and so on. Accordingly, the curve 506 may be updated in real-time.
Regarding claims 36 – 38 Leabman as modified by Miller et al. as set forth above does not specifically teach provide an instruction to the user to engage in an activity that causes a change in a level of the analyte.
Koehler et al. teaches in the same field of endeavor methods for presenting glucose level data. Glucose data for a patient may be received. A current glucose level and a rate of change of the current glucose level may be determined based on the received glucose data. A first interface may be displayed on a screen of a device. The first interface may include a unitary icon. The unitary icon may display the current glucose level and a visualization of the rate of change. Paragraph [0203] FIG. 8B, the application may apply a yellow color scheme 1720 to indicate that the patient may be in danger of becoming hyperglycemic. In some implementations, application 255 may apply a red color scheme 1710 for a high-risk situation, a yellow color scheme 1720 for a moderate risk situation, and no shading or a grey shading for a relatively low risk situation. The shading on the screen may discreetly prompt the patient or remote monitor to take action to raise or lower the patient's glucose level as needed.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Leabman as modified by Miller et al. a display and prompt for the user to take an action to raise or lower the user’s glucose or analyte level as taught by Koehler et al. to help the user better manage their health and avoid high risk health situations.
It is noted that there are a limited number of choices available to a person of ordinary skill in the art for changing a corresponding analyte level. Therefore, it would have been obvious to one of ordinary skill in the art to try changing physical activity or reducing blood pressure or other activities as a matter of design choice to effect blood glucose or other anlaytes, with a reasonable expectation of success. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leabman(US 20200193326 ) hereinafter Leabman in view of Miller et al.( US 11540751) hereinafter Miller et al. and further in view of Koehler et al.( US 20160119210) hereinafter Koehler et al. and further in view of Gill(20200054258) hereinafter Gill.
Regarding claim 28, Leabman as modified by Miller et al. and Koehler et al. does teach in Miller et al. (220) In an embodiment, the wearable device 100 may include one or more sensors and/or programming that may determine when the patient is engaged or about to become engaged in an activity that may lead to drift in the analyte measurement.
However, Leabman as modified by Miller et al. and Koehler et al. does not specifically teach the use of an accelerometer to measure the activity.
It is noted that there are a limited number of choices available to a person of ordinary skill in the art for measuring movement or activity and an accelerometer is a well know device for measuring movement or activity of an object.
Gill teaches a wearable continuous glucose monitor can include an additional module (i.e., a secondary sensor) that contains a sensor such as an accelerometer to track steps and movement of a patient (see Gill, par 0174).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Leabman as modified by Miller et al. and Koehler et al. such that the wearable sensing device includes an accelerometer as taught by Gill that is different from the second sensor because that would improve the system of Leabman as modified by Miller et al. and Koehler et al. by enabling the wearable sensing device to use the accelerometer data to track steps and movement of a patient which aids in tracking the patient’s health (see Gill, par 0174).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leabman(US 20200193326 ) hereinafter Leabman in view of Miller et al.( US 11540751) hereinafter Miller et al. and further in view of Koehler et al.( US 20160119210) hereinafter Koehler et al. and further in view of Swenson(20150289790) hereinafter Swenson..
With respect to claim 30 Leabman as modified by Miller et al. and Koehler et al. teaches the wearable sensing device of claim 18.
As demonstrated above, Leabman as modified by Miller et al. and Koehler et al. teaches a wearable sensing device comprising a non-invasive analyte sensor including a plurality of transmit antennas and a plurality of receive antennas that are configured to detect an analyte of a user.
Leabman as modified by Miller et al. and Koehler et al. does not teach the non-invasive analyte sensor is part of a first sensing device that is removably attached to the wearable sensing device, and that the wearable sensing device further comprises a second sensing device that is removably attachable to the wearable sensing device and that is configured to detect a second analyte different from the first analyte, the second sensing device being different from the second sensor.
Swenson teaches a watch 300 that comprises metabolic physical activity monitors 120 that are removable sensor elements. The watch uses the plurality of separate removable sensor elements 120 that have different sensing capabilities to obtain metabolic data of a user (i.e., analytes from sweat of a user such as pH, urea, or pCO2) (see Swenson, par 0035, 0045-0048, fig. 3 & 6-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable sensing device of Leabman as modified by Miller et al. and Koehler et al. such that the non-invasive analyte sensor is part of a first sensing device that is removably attached to the wearable sensing device, and that the wearable sensing device further comprises a second sensing device that is removably attachable to the wearable sensing device and that is configured to detect a second analyte different from the first analyte, the second sensing device being different from the second sensor, because that would improve the system of Leabman as modified by Miller et al. and Koehler et al. by enabling the system to measure different analytes of a user, thereby more comprehensively measuring the health of a user (i.e., by measuring a plurality of analytes such as different metabolites indicative of a user’s physical activity) (see Swenson, par 0035, 0045-0048).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
BURNETTE(US 20210361162) teaches analyte measurement values are calculated and stored (804) based upon the received sensor information. One or more communication conditions are determined (806). A transceiver is instructed (808) to advertise the measurement values to a first display device with respect to one or more communication variables based upon the communication conditions. The estimated analyte measurement values are transmitted (812) to the first display device. The sensor information is received from a continuous glucose monitoring sensor. The analyte measurement values comprise estimated glucose values.
Sjolund(US 20190183434) teaches a diabetes management system. Such a diabetes management system may include a flash glucose monitor and a user interface. The user interface may be configured to display one or more of graphical representations of glucose values and value representative of glucose measurements, and to change values displayed responsive to user interaction with the user interface.
Davis et al.( US 20170220751) teaches [0008] Systems and methods according to present principles relate to decision-making for management of diabetes. People with diabetes face many problems in controlling their glucose because of the complex interactions between food, insulin, exercise, stress, activity, and other physiological and environmental conditions. Established principles of management of glucose sometimes are not adequate because there is a significant amount of variability in how different conditions impact different individuals and what actions might be effective for them.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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