DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 3/8/2024. Claims 6-15 and second claim 5 are cancelled. Claims 16-26 are new. Claims 1-5 and 16-26 are currently pending.
Claim Rejections - 35 USC § 103
3. 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.
3.1. Claims 1-5, 17-21, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US 2017/0021171), in view of Connor (US 2017/0164878).
CLAIM 1
Perez teaches a wearable unit (Perez: abstract) comprising:
a housing configured to be worn on a body of a patient (Perez: abstract; ¶¶ [0372] “electro-dermal patch device is wearable”, [0403] “housing”, [0577]-[0579]; FIGS. 21A-21B); and
an electronics module (Perez: abstract; ¶¶ [0372] “electro-dermal patch device”, [0577]-[0579]; FIGS. 21A-21B) comprising:
a power source (Perez: abstract; ¶¶ [0401] “a power management module 120, such as a lithium-ion battery, a betavoltaic battery, a solar cell, nickel-cadmium battery, or a fuel cell. In some embodiments, the power management module 120 comprises a battery having a voltage”, [0577]-[0579]; FIGS. 1A-1F, 21A-21B);
plurality of sensors comprising a temperature sensor configured to sense a temperature of the patient, a pulse oximeter configured to sense an oxygen saturation of the patient, an accelerometer configured to sense a breathing pattern of the patient, a skin conductance sensor configured to sense a skin conductance of the patient, and an electrocardiogram (ECG) monitor configured to sense an ECG pattern of the patient (Perez: abstract; ¶¶ [0238], [0402], [0404]-[0405]; Table 1; FIGS. 1A-5F); and
a microcontroller configured to receive an output from one or more of the plurality of sensors and to determine, whether the output indicates one of hyperglycemia (Perez: abstract; ¶¶ [0392] “microcontroller”, [0401], [0512] “detect conditions such as a hyperglycemic”; FIGS. 1A-5F, 21A-21B).
Perez does not appear to explicitly teach the following:
and hypoglycemia.
Connor, however, teaches the following:
and hypoglycemia (Connor: abstract; ¶¶ [0400] “detect, predict, reduce, and/or avoid hypoglycemia, hyperglycemia”; FIGS. 1-72).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the wearable technology for non-invasive glucose monitoring, as taught by Connor, with the electro-dermal patch with sensors, as taught by Perez, with the motivation of providing a more accurate non-invasive measurement of body glucose levels (Connor: abstract; ¶¶ [0014]-[0015]).
CLAIM 2
Perez teaches the wearable unit according to claim 1, further comprising: a wristband configured to attach the housing to a wrist of the patient (Perez: abstract; ¶¶ [0577] “wristband”; FIGS. 21A-21B).
CLAIM 3
Perez teaches the wearable unit according to claim 2, the microcontroller further comprising a Bluetooth module, wherein the microcontroller is further configured to transmit information to an external device, the information comprising at least one of the output from the one or more of the plurality of sensors and a determination of whether the output indicates one of hyperglycemia and hypoglycemia (Perez: abstract; ¶¶ [0400] “system 100 comprises an electro-dermal patch (EDP) device 110 in data communication with a companion device 105…Bluetooth”; FIGS. 1A-1F, 21A-21B).
CLAIM 4
Perez does not appear to explicitly teach the wearable unit according to claim 1, further comprising: an earpiece configured to hold the housing within an ear of the patient.
Connor, however, teaches further comprising: an earpiece configured to hold the housing within an ear of the patient (Connor: abstract; ¶¶ [0354]-[0358] “an ear-worn diagnostic component can be an ear-inserted component which is inserted (partially or fully) into an ear canal”; FIGS. 1-72).
The motivation to include the teachings of Connor with the teachings of Perez is the same as that of claim 1 above and is incorporated herein.
CLAIM 5
Perez teaches the wearable unit according to claim 4, the microcontroller further comprising a Bluetooth module, wherein the microcontroller is further configured to transmit information to an external device, the information comprising at least one of the output from the one or more of the plurality of sensors and a determination of whether the output indicates one of hyperglycemia and hypoglycemia (Perez: abstract; ¶¶ [0400] “system 100 comprises an electro-dermal patch (EDP) device 110 in data communication with a companion device 105…Bluetooth”; FIGS. 1A-1F, 21A-21B).
CLAIM 17
Perez teaches a sensing system (Perez: abstract) comprising:
an external device (Perez: abstract; ¶¶ [0372] “electro-dermal patch device”, [0403], [0577]-[0579]; FIGS. 21A-21B); and
a wearable unit (Perez: abstract; ¶¶ [0372] “electro-dermal patch device is wearable”, [0403], [0577]-[0579]; FIGS. 21A-21B) comprising:
a housing configured to be worn on a body of a patient (Perez: abstract; ¶¶ [0372] “electro-dermal patch device is wearable”, [0403] “housing”, [0577]-[0579]; FIGS. 21A-21B); and
an electronics module (Perez: abstract; ¶¶ [0401]-[0404] “electro-dermal patch device”; FIGS. 1-45) comprising:
a power source (Perez: abstract; ¶¶ [0401] “a power management module 120, such as a lithium-ion battery, a betavoltaic battery, a solar cell, nickel-cadmium battery, or a fuel cell. In some embodiments, the power management module 120 comprises a battery having a voltage”, [0577]-[0579]; FIGS. 1A-1F, 21A-21B);
a plurality of sensors comprising a temperature sensor configured to sense a temperature of the patient, a pulse oximeter configured to sense an oxygen saturation of the patient, an accelerometer configured to sense a breathing pattern of the patient, a skin conductance sensor configured to sense a skin conductance of the patient, and an electrocardiogram (ECG) monitor configured to sense an ECG pattern of the patient (Perez: abstract; ¶¶ [0238], [0402], [0404]-[0405]; Table 1; FIGS. 1A-5F);
a transmission unit (Perez: abstract; ¶¶ [0413]-[0416], [0485]-[0487]; FIGS. 1A-6F, 21A-21B ); and
a microcontroller (Perez: abstract; ¶¶ [0392] “microcontroller”, [0401]; FIGS. 1A-5F, 21A-21B) configured to:
receive an output from one or more of the plurality of sensors (Perez: abstract; ¶¶ [0413]-[0416], [0485]-[0487]; FIGS. 1A-6F, 21A-21B), and
control the transmission unit to output, to the external device, information comprising the output from the one or more of the plurality of sensors (Perez: abstract; ¶¶ [0413]-[0416], [0485]-[0487]; FIGS. 1A-6F, 21A-21B);
wherein the external device is configured to receive the information from the wearable device and to determine whether the output indicates one of hyperglycemia (Perez: abstract; ¶¶ [0392], [0401], [0512] “detect conditions such as a hyperglycemic”; FIGS. 1A-5F, 21A-21B).
Perez does not appear to explicitly teach the following:
and hypoglycemia.
Connor, however, teaches the following:
and hypoglycemia (Connor: abstract; ¶¶ [0400] “detect, predict, reduce, and/or avoid hypoglycemia, hyperglycemia”; FIGS. 1-72).
The motivation to include the teachings of Connor with the teachings of Perez is the same as that of claim 1 above and is incorporated herein.
CLAIM 18
Perez teaches the sensing system according to claim 17, the wearable unit further comprising a wristband configured to attach the housing to a wrist of the patient (Perez: abstract; ¶¶ [0577] “wristband”; FIGS. 21A-21B).
CLAIM 19
Perez teaches the sensing system according to claim 17, wherein the transmission unit comprises a Bluetooth module (Perez: abstract; ¶¶ [0400] “system 100 comprises an electro-dermal patch (EDP) device 110 in data communication with a companion device 105…Bluetooth”; FIGS. 1A-1F, 21A-21B).
CLAIM 20
Perez does not appear to explicitly teach the sensing system according to claim 17, the wearable unit further comprising an earpiece configured to hold the housing within an ear of the patient.
Connor, however, teaches the wearable unit further comprising an earpiece configured to hold the housing within an ear of the patient (Connor: abstract; ¶¶ [0354]-[0358] “an ear-worn diagnostic component can be an ear-inserted component which is inserted (partially or fully) into an ear canal”; FIGS. 1-72).
The motivation to include the teachings of Connor with the teachings of Perez is the same as that of claim 1 above and is incorporated herein.
CLAIM 21
Perez teaches the sensing system according to claim 20, wherein the transmission unit comprises a Bluetooth module (Perez: abstract; ¶¶ [0400] “system 100 comprises an electro-dermal patch (EDP) device 110 in data communication with a companion device 105…Bluetooth”; FIGS. 1A-1F, 21A-21B).
CLAIMS 23-26
Claims 23-26 repeat substantially the same limitations as those in claims 1-4. As such, claims 23-26 are rejected for substantially the same reasons given for claims 1-4 and are incorporated herein.
3.2. Claims 16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US 2017/0021171), in view of Connor (US 2017/0164878), and further in view of Zribi et al. (US 2007/0004975).
CLAIM 16
Perez and Connor do not appear to explicitly teach the wearable unit according to claim 1, the electronics module further comprising: an output unit, wherein the microcontroller is further configured to output at least one of a visible alert and an audible alert to the patient based on whether the output indicates one of hyperglycemia and hypoglycemia.
Zribi, however, teaches the electronics module further comprising: an output unit, wherein the microcontroller is further configured to output at least one of a visible alert and an audible alert to the patient based on whether the output indicates one of hyperglycemia and hypoglycemia (Zribi: abstract; ¶¶ [0028] “analysis unit may generate alerts based on the glucose levels via a routine embedded with a processor in the analysis unit. For example, in conditions such as hypoglycemia or hyperglycemia, the portable analysis unit may generate an audible (such as an alarm or audio notification) and/or a visual alert (such as a text alert, light indication, color indication, and so forth)”; FIGS. 1-4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the non-invasive glucose monitoring system, as taught by Zribi, with the wearable technology for non-invasive glucose monitoring, as taught by Connor, with the electro-dermal patch with sensors, as taught by Perez, with the motivation of providing improved monitoring and management of glucose levels (Zribi: abstract; ¶¶ [0001]-[0008], [0028]).
CLAIM 22
Perez and Connor do not appear to explicitly teach the sensing system according to claim 17, wherein the external device is further configured to determine to output at least one of a visible alert and an audible alert to the patient based on whether the output indicates one of hyperglycemia and hypoglycemia.
Zribi, however, teaches wherein the external device is further configured to determine to output at least one of a visible alert and an audible alert to the patient based on whether the output indicates one of hyperglycemia and hypoglycemia (Zribi: abstract; ¶¶ [0028] “analysis unit may generate alerts based on the glucose levels via a routine embedded with a processor in the analysis unit. For example, in conditions such as hypoglycemia or hyperglycemia, the portable analysis unit may generate an audible (such as an alarm or audio notification) and/or a visual alert (such as a text alert, light indication, color indication, and so forth)”; FIGS. 1-4).
The motivation to include the teachings of Zribi with the teachings of Perez and Connor is the same as that of claim 16 above and is incorporated herein.
Conclusion
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681