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 .
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 5 and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 13 recite the limitation "the at least one feature value" in lines five and four, respectively. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this should read “the at least one numerical feature value” or not. For purposes of examination, it is understood that it should read “the at least one numerical feature value.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 8-12, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0289055 A1 to Vleugels in view of US 2015/0141770 A1 to Rastogi et al. (“Rastogi”).
As to claim 1, Vleugels discloses a wearable electronic device (see [0268] – “The electronic device 218 may also be integrated in a patch that can be attached to a person's arm or wrist.”) comprising:
a first sensor (see [0453] – "the measurement sensor unit 1904 is a continuous glucose monitor sensor that measures interstitial glucose levels"; see also [0571]);
a second sensor (see [0154] – "the food intake detection system 101 may monitor the outputs of accelerometer and/or gyroscope sensors to detect a possible bite gesture or a possible sip gesture");
memory, comprising one or more storage media, storing instructions (see [0257]) -- Electronic device 218 typically includes, in part, one or more sensor units 627, a processing unit 628, memory 629 that can include or be realized as computer-readable storage media having program code instructions…”); and
one or more processors communicatively coupled to the first sensor, the second sensor, and the memory (see above),
wherein the instructions, when executed by the one or more processors individually or collectively, cause the wearable electronic device to:
measure a plurality of first blood sugar levels of a user in a first cycle using the first sensor, the first cycle defining a first measurement frequency, so as to store a first blood sugar level of the plurality of first blood sugar levels in the memory, the first blood sugar level being measured according to the first cycle (see [0124] – "Interstitial glucose levels can be measured automatically and periodically using a continuous glucose monitoring device"; [0269] – "The raw sensor outputs may be stored locally in memory 629"; see also [0134], which uses "the glucose level readings in a certain time window preceding the current food intake event," i.e., stored pre-event readings),
detect a specified event using the second sensor (see [0155] – “…the food intake event detection system 101 may decide that the start of a food intake event has occurred when the confidence level of the bite or sip gesture exceeds a pre-configured threshold.”),
in case that the specified event is detected, measure a plurality of second blood sugar levels of the user in a second cycle using the first sensor, the second cycle defining a second measurement frequency different than the first measurement frequency, so as to store at least one second blood sugar level of the plurality of second blood sugar levels in the memory, the at least one second blood sugar level being measured according to the second cycle (see [0573] – “…when the dietary tracking and feedback system 1902 detects the actual or probable start of an event of interest, it may send a suitably formatted output 2704 or signal to the measurement sensor unit 1904 and/or the measurement sensor processing unit 1909. Upon receiving the output 2704, or some time thereafter, the measurement sensor unit 1904 and/or the measurement sensor processing unit 1909 may initiate an appropriate state change. Such a state change may include any of the following, without limitation: (1) activating a higher performance mode of one or more circuits or components; (2) supplying additional power to one or more circuits; (3) increasing the sampling rate of the measurement sensor unit 1904; (4) reducing latency of a communication channel such as an increased sensor read out frequency, or a reduced latency in communication between the measurement sensor processing unit 1909 and the medication dosing calculation unit 1906 (see FIG. 21); (5) increasing buffer space allocated for data storage.”; see also [0601] -- "altering a measurement sampling rate of the measurement sensor"; and [0602] – "The sensor data and/or the sensor measurement information is generated, processed, and/or communicated in a manner that is influenced by the provided event information"), and
calculate at least one numerical feature value related to blood sugar of the user, based on the first blood sugar level and the at least one second blood sugar level (see [0134] – "Examples of parameters derived from glucose level readings could be the current slope (i.e. first derivative), the second or higher order derivative of a glucose level reading, the maximum, mean, minimum value of the glucose level readings in a certain time window preceding the current food intake event"; see also [0451] – "An insulin dosage calculator can take into account glucose level at start of eating, a first or higher order derivative of the glucose level at start of eating…"; and [0144] – "…adjust the schedule or insulin amounts upwards or downwards based on observed changes in blood glucose level readings…").
Vleugels fails to disclose wherein the first and second sensor are part of the same wearable electronic device. But Rastogi teaches this (see [0030] – "In some non-limiting embodiments, as illustrated in FIG. 1, the system 120 may include an activity tracker 110 (e.g., an on-body activity tracker such as, for example and without limitation, a fitbit), which may include an accelerometer 111 in addition to or as an alternative to the accelerometer 105. In some non-limiting embodiments, the analyte sensor 100 and/or display device 102 may additionally or alternatively include an accelerometer. In some embodiments, the transceiver 101 may be configured to generate activity information based on acceleration data generated by one or more accelerometers and may be configured to generate one or more alerts based on the activity information. In some embodiments, the transceiver 101 may be configured to additionally or alternatively receive activity information (e.g., from display device 102 or activity tracker 110) that was generated (e.g., by display device 102 or activity tracker 110) based on acceleration data generated by one or more accelerometers. In some embodiments, the transceiver 101 and/or display device 102 may communicate the one or more alerts to a user. In some embodiments, the alerts may be visual, audible, and/or vibratory alerts."; see also [0037], [0047] and [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Vleugels to house both the first sensor (glucose sensor) and the second sensor (accelerometer) in the same device so as to simplify the device and make it more convenient such that it does not require the user to rely on several devices.
As to claim 2, Vleugels further discloses wherein the instructions, when executed by the one or more processors individually or collectively, further cause the wearable electronic device to set the first blood sugar level as an initial value of a change in the blood sugar of the user when the specified event is detected (see [0451] – "glucose level at start of eating, a first or higher order derivative of the glucose level at start of eating"; [0134] – "the glucose level readings in a certain time window preceding the current food intake event").
As to claim 3, Vleugels further discloses wherein the specified event corresponds to an event indicating that the user starts to eat food (see [0155] – "the food intake event detection system 101 may decide that the start of a food intake event has occurred"; see also [0208]).
As to claim 4, Vleugels further discloses wherein the second cycle measurement frequency is higher than the first measurement frequency (see [0573] – "(3) increasing the sampling rate of the measurement sensor unit 1904").
As to claims 8 and 20, Vleugels further discloses wherein the at least one numerical feature value comprises at least one of a current blood sugar level, a fasting blood sugar level, a rate of change in blood sugar, a direction of change in blood sugar, a blood sugar response area, a slope of a blood sugar rise curve, a maximum blood sugar level, a change in blood sugar before and after eating food, a time required to return to the fasting blood sugar after eating food, a number of blood sugar peaks, or occurrence intervals of food intake events (see [0134] and [0451]).
Claim 9 is rejected for the reasons set forth in the treatment of claim 1, mutatis mutandis.
Claim 10 is rejected for the reasons set forth in the treatment of claim 2, mutatis mutandis.
Claim 11 is rejected for the reasons set forth in the treatment of claim 3, mutatis mutandis.
Claim 12 is rejected for the reasons set forth in the treatment of claim 4, mutatis mutandis.
As to claims 16 and 18, Vleugels does not appear to disclose wherein the instructions, when executed by the one or more processors individually or collectively, further cause the wearable electronic device to:
compare the at least one numerical feature value with a threshold; and
based on a result of comparing the at least one feature value with the threshold, determine whether or not to provide a notification related to the blood sugar of the user.
However, Rastogi discloses this (see [0049] – “In some embodiments, the transceiver 100 may be configured to vibrate and/or generate an audio or visual signal to prompt the user about analyte readings outside an acceptable limit, such as hypo/hyper glycemic alerts and alarms in the case where the analyte is glucose.”). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Vleugels and Rastogi in order to achieve the predictable result of informing the user regarding acute health risks associated with hyper-/hypoglycemia.
As to claims 17 and 19, Rastogi further discloses wherein the notification comprises at least one piece of information about the health condition of the user and information related to a diet or exercise guide determined based on the at least one numerical feature value (see [0047]-[0049] - hyperglycemia is related to diet in that it is often caused by the user eating the wrong types and/or amounts of food).
Claim(s) 5-7 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vleugels in view of Rastogi as applied to claims 1 and 9 above, and further in view of US 2014/0148659 A1 to Sloan et al. (“Sloan”).
As to claims 5 and 13, neither Vleugels nor Rastogi discloses wherein the instructions, when executed by the one or more processors individually or collectively, further cause the wearable electronic device to:
compare the at least one numerical feature value with a threshold; and
based on a result of comparing the at least one feature value with the threshold, measure a plurality of third blood sugar levels of the user in a third cycle using the first sensor, the third cycle defining a third measurement frequency different from the second measurement frequency.
However, in a similar invention, Sloan teaches instructions, when executed by one or more processors individually or collectively, further cause an electronic device to:
compare the at least one numerical feature value with a threshold (see [0080] – the rate of change is compared to a threshold); and
based on a result of comparing the at least one feature value with the threshold, measure a plurality of third blood sugar levels of the user in a third cycle using the first sensor, the third cycle defining a third measurement frequency different from the second measurement frequency (see [0080]-[0081] – various levels of frequencies may be used).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Vleugels and Rastogi with the dynamic, several frequencies taught by Sloan in order to achieve the predictable result of allowing the system to conserve resources when data is quiescent and progressively consume more resources when the glucose levels are changing more and more rapidly. While Sloan expressly teaches slow and fast frequencies, one of ordinary skill in the art would have known to choose any number of frequency levels, as needed.
As to claims 6 and 14, Sloan further discloses wherein the third cycle-measurement frequency is higher than the second measurement frequency (see [0080]-[0081] – there are slower and faster frequencies).
As to claims 7 and 15, Sloan further discloses wherein the instructions, when executed by the one or more processors individually or collectively, further cause the wearable electronic device to change a measurement cycle of the first sensor from the second cycle to the first cycle in case that a third blood sugar level of the user, which is measured using the first sensor when a specified time elapses after the specified event is detected, is less than or equal to a threshold (see [0090]-[0093] – the rate of change is analyzed over certain epochs).
Response to Arguments
Applicants’ arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicants’ 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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
