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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 30, 2025 has been entered. The Examiner acknowledges the amendments made to claims 18-21 and 28-30, the cancellation of claims 1-17 and 23-27, and the addition of claims 34 and 35. Claims 18-22 and 28-35 are currently pending.
Response to Arguments
Applicant's arguments filed June 30, 2025 have been fully considered but they are not persuasive. Regarding the rejection of the claims under 35 USC 112(b), though Applicant’s amendments have overcome some of the previous rejections of the claims under 35 USC 112(b), indefiniteness issues remain within the claims. Regarding claim 18, there is insufficient antecedent basis for “the analyte data” recited at line 19, and as such, it is unclear as to what analyte data the claim is referring. See 35 USC 112(b) rejections below.
Regarding the rejection of the claims under 35 USC 103, Applicant argues Leabman fails to disclose a second sensor, a sensing period for detecting an analyte, receiving data detected by a second sensor during the sensing period, and a determined correlation between the detected analyte and the data detected by the second sensor during the sensing period. Furthermore, Applicant argues Leabman as modified by Menon, Gill, or Swenson fails to teach the wearable sensing device being able to detect, via the non-invasive analyte sensor, the analyte during a sensing period, receiving data detected by a second sensor during the sensing period, and indicating a determined correlation between the detected analyte and the data detected by the second sensor during the sensing period.
The Examiner respectfully disagrees with these arguments. Menon teaches a wearable sensing device that comprises a PPG sensor that is used to detect blood glucose, blood pressure, pulse rate, or oxygen saturation (SpO2) of a user and additional sensor units, such as an accelerometer, temperature sensor, or pressure sensor to detect other physiological parameters of a user (see Menon, par 0034-0035, 0038 & 0048). Therefore, Leabman as modified by Menon does teach a sensing device by which two cooperating sensors are provided such that a determination includes at least two or more of a user’s temperature, heart rate, oxygen saturation, blood pressure, activity, sleep, or an additional analyte. Furthermore, Gill teaches a continuous glucose monitor system (i.e., CGM) that comprises at least one secondary sensor (i.e., an activity sensor, an accelerometer, a temperature sensor or a heart-rate sensor) (see Gill, par 0034-0035, 0040-0041), wherein the secondary sensor is used to track activity and other biometrics along with blood glucose of a patient to identify trends in what affects the blood glucose levels of the patient (see Gill, par 0172). Further, Gill teaches measurement data obtained from a primary sensor and measurement data obtained from a secondary sensor comprises a plurality of measurement values acquired in a period of several hours, several days, several weeks, or several months (see Gill, par 0054, 0174). Therefore, Leabman as modified by Menon and Gill teaches a second sensor, a sensing period for detecting an analyte, receiving data detected by a second sensor during the sensing period, and a determined correlation between the detected analyte and the data detected by the second sensor during the sensing period. Therefore, the rejection of the claims under 35 USC over the previously cited prior art still stands. See 35 USC 103 rejections below.
Claim Objections
Claim 30 is objected to because of the following informalities: "wherein the non-invasive analyte sensor that includes the at least one transmit antenna and the at least one receive antenna as part of a first sensing device that is removably attached to the wearable sensing device and that is configured to detect the analyte as a first analyte" at lines 1-4 should read as --wherein the non-invasive analyte sensor that includes the at least one transmit antenna and the at least one receive antenna is part of a first sensing device that is removably attached to the wearable sensing device and that is configured to detect the analyte as a first analyte-- or alternatively --wherein the non-invasive analyte sensor includes the at least one transmit antenna and the at least one receive antenna as part of a first sensing device that is removably attached to the wearable sensing device and that is configured to detect the analyte as a first analyte--.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “indicate a determined correlation between the detected analyte of the analyte data and the data detected by the second sensor during the sensing period” (emphasis added) at lines 19-20. There is insufficient antecedent basis for this limitation in the claim. As such, it is unclear as to what analyte data the claim is referring. For examination purposes, it will be interpreted that a correlation is determined between an analyte detected by the non-invasive analyte sensor and data detected by the second sensor.
Dependent claims are similarly rejected as their base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 18-22, 28-29 & 31-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20200193326 --as previously cited--, hereinafter referenced as "Leabman" in view of US Patent Application Publication 20190192086 --as previously cited--, hereinafter referenced as "Menon", and in further view of US Patent Application Publication 20200054258 –as previously cited--, hereinafter referenced as “Gill”.
With respect to claims 18 & 19, 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 teach the wearable sensing device includes at least one rechargeable battery that provides electrical power to power operation of the wearable sensing device.
Menon teaches a wearable sensing device 100 that includes at least one rechargeable battery 140 that provides electrical power to power operation of the wearable sensing device (see Menon, par 0034, fig. 1).
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 such that the wearable sensing device includes at least one rechargeable battery that provides electrical power to power operation of the wearable sensing device because that would improve the system of Leabman by enabling the wearable sensing device to easily be recharged (see Menon, par 0034).
Furthermore, Leabman does not 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.
Menon teaches the wearable sensing device 100 comprises a PPG sensor that is used to detect blood glucose, blood pressure, pulse rate, or oxygen saturation (SpO2) of a user, and additional sensor units, such as an accelerometer, temperature sensor, or pressure sensor to detect other physiological parameters of a user (see Menon, par 0034-0035, 0038 & 0048).
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 such that the wearable sensing device comprises a second sensor (i.e., a PPG sensor or any of the additional sensor units) that detects the two or three or more additional data parameters that are received by the wearable sensing device because that would improve the device of Leabman by acquiring data from additional sensors that indicate additional parameters of a user’s health (see Menon, par 0010, 0034, 0040, 0049, 0051).
Leabman as modified by Menon fails to teach the wearable sensing device is configured to indicate a determined correlation between the detected analyte and the data detected by the second sensor during a sensing period. Leabman as modified by Menon further fails to teach the wearable sensing device detects the analyte via the non-invasive analyte sensor during the sensing period and receives data detected by the second sensor during the sensing period.
Gill teaches a continuous glucose monitor system (i.e., CGM) that comprises at least one secondary sensor (i.e., an activity sensor, an accelerometer, a temperature sensor or a heart-rate sensor) (see Gill, par 0034-0035, 0040-0041), wherein the secondary sensor is used to track activity and other biometrics along with blood glucose of a patient to identify trends in what affects the blood glucose levels of the patient (see Gill, par 0172). Furthermore, Gill teaches measurement data obtained from the primary sensor (i.e., the first subsystem) that measures glucose and measurement data from the secondary sensor that can be an activity sensor, an accelerometer, a temperature sensor or a heart-rate sensor (i.e., the second subsystem) comprises a plurality of measurement values acquired in a period of several hours, several days, several weeks, or several months (see Gill, par 0054, 0174). Collecting such measurement data for extended periods of time permits better tracking of a patient’s health, and permits the adjustment of treatment protocols if necessary (see Gill, par 0174).
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 Menon such that the wearable sensing device is configured to indicate a determined correlation between the detected analyte and the data detected by the second sensor during a sensing period, detect the analyte via the non-invasive analyte sensor during the sensing period, and receive data detected by the second sensor during the sensing period because that improves the system/device by identifying trends in what makes blood glucose high or low for a patient/user, which a patient can use to inform decision-making in their diabetes management or health management overall (see Gill, par 0172), and further permits better tracking of a patient’s health, and the adjustment of treatment protocols if necessary since the measurement data is detected over an extended period of time (see Gill, par 0174).
With respect to claim 20, Leabman as modified by Menon and Gill further teaches the second sensor (i.e., a PPG sensor or additional sensor units) 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 (i.e., the wearable sensing device comprises a temperature sensor to detect user temperature and a photodetector that uses the photoplethysmography (PPG) technique to detect user blood pressure, pulse rate, and blood oxygen level (SpO2)) (see Menon, par 0034-0035 & 0038, see Gill, par 0054, 0174).
With respect to claims 21 & 29, Leabman in view of Menon and in further view of Gill teaches the wearable sensing device of claim 18. Leabman further teaches that the analyte detected by the non-invasive analyte sensor includes blood glucose of a user (see Leabman, par 0063, 0075, 0124).
Leabman does not teach the wearable sensing device includes an oxygen saturation monitor, the oxygen saturation monitor being the second sensor that detects user oxygen saturation.
Menon teaches a wearable sensing device 100 that includes an oxygen saturation monitor (i.e., the wearable sensing device comprises a photodetector that uses the photoplethysmography (PPG) technique to detect user blood oxygen level (SpO2)) (see Menon, par 0034-0035 & 0038).
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 such that the wearable sensing device includes an oxygen saturation monitor as the second sensor that detects user oxygen saturation because that would improve the system of Leabman by enabling the wearable sensing device to measure additional physiological parameters of a user that aid in the monitoring of a user’s health condition (see Menon, abstract, par 0033-0035 & 0038).
With respect to claim 22, Leabman further teaches the wearable sensing device comprises a watch 100 with a wristband 104 (i.e., a smartwatch with a strap) (see Leabman, par 0062, 0068, figs. 1A & 1B).
With respect to claim 28, Leabman as modified by Menon does not teach the wearable sensing device includes an accelerometer different from the second sensor.
Gill teaches the 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).
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 Menon such that the wearable sensing device includes an accelerometer that is different from the second sensor because that would improve the system of Leabman as modified by Menon 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).
With respect to claim 31, Leabman in view of Menon and in further view of Gill teaches the wearable sensing device of claim 18, and further teaches the second sensor is separate from the wearable sensing device (i.e., the additional sensors of the wearable device are present in a local computing device rather than the wearable sensing device) (see Menon, par 0010, 0036, 0040, claims 1, 3 & 7).
With respect to claim 32, Leabman in view of Menon and in further view of Gill teaches the wearable sensing device of claim 18. Leabman in view of Menon further teaches the correlation between the detected analyte and the data detected by the second sensor is determined by the wearable sensing device (i.e., the additional sensor units of the wearable device are used to obtain data that is correlated with acquired PPG signals from the PPG sensor of the wearable device (i.e., PPG signals of a user’s blood glucose levels) to correct external interferences on the PPG signals (i.e., external interferences include shivering, applied pressure, or horizontal and vertical movements of a user), or to compute patient-specific threshold ranges of the PPG data) (see Menon, par 0010, 0034-0035, 0040, 0049, 0051).
With respect to claim 33, Leabman in view of Menon and in further view of Gill teaches the wearable sensing device of claim 18. Leabman fails to teach that the correlation between the detected analyte and the data detected by the second sensor is determined by a separate server.
Menon teaches the wearable device is connected to a remote computing device such as a cloud-based server wherein PPG signal data may be processed with the cloud-based server (see Menon, par 0036, 0038, 0045, 0046). Menon further teaches that sensor reading patterns (i.e., a correlation between detected physiological parameters) can be detected and distributed through the cloud-based server to provide synchronization of results, notifications, and updates for patients (see Menon, par 0046, 0048-0049).
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 such that the correlation between the detected analyte and the data detected by the second sensor is determined by a separate server because that would improve the system of Leabman by permitting the computation of patient/user data on a server that synchronizes results, notifications and updates for patients on the server (see Menon, par 0046, 0048-0049).
With respect to claims 34 & 35, Leabman as modified by Menon and Gill teaches the sensing device of claim 18, and further teaches the sensing period is equal to or greater than 1 hour, and the sensing period is equal to or greater than 8 hours (i.e., measurement data obtained from a primary sensor and a secondary sensor comprises a plurality of measurement values acquired in a period of several hours, several days, several weeks, or several months) (see Gill, par 0054, 0174).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leabman in view of Menon and in further view of Gill as applied to claim 18 above, in further view of US Patent Application Publication 20150289790 --as previously cited--, hereinafter referenced as "Swenson".
With respect to claim 30, Leabman in view of Menon and in further view of Gill teaches the wearable sensing device of claim 18.
As demonstrated above, Leabman as modified 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 (see rejection of claims 18-21 & 29 above).
Leabman as modified 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 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 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791