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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-6, 9-10, 14-16, 18-19, and 22-24 in the reply filed on September 12, 2025 is acknowledged.
Claims 7-8, 11-13, 17, 20-21, and 25-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 12, 2025.
As a reminder, in accordance with MPEP § 714(II)(C)(A), for any amendment being filed in response to a restriction requirement and any subsequent amendment, any claims which are non- elected must have the status identifier (withdrawn). Any non-elected claims which are being amended must have either the status identifier (withdrawn) or (withdrawn – currently amended) and the text of the non-elected claims must be presented with markings to indicate the changes. Any non-elected claims that are being canceled must have the status identifier (canceled).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
It is noted that the wearable analyte monitoring device is not positively claimed in claims 22 and 24. So, the wearable analyte monitoring device is interpreted as not being part of the claimed apparatus and merely functionally associated with the apparatus.
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 14-16 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.
Claim 14 recites a “computer-implemented method,” which suggests that the method steps are performed at a single computer or device, while the claim steps indicate various devices performing the steps. It is suggested to delete the phrasing “computer-implemented”. Claims 15 and 16 are rejected by virtue of dependency.
Claim Rejections - 35 USC § 102
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 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.
Claims 22-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gill (US 2020/0054258).
Regarding claim 22, Gill teaches an apparatus (second subsystem 110 or sensor module 344) comprising: one or more sensors to collect physiological data of a user (“The secondary sensor of the second subsystem may be configured for collecting at least one of physiological data, physical data from the host,” par. 40); and an underlay patch (body mount 216, Figs. 7-8; see also patch 310, Fig. 9; and patch 356, Fig. 13) configured to directly contact skin of the user (“the body mount 216 may be physically attachable to the host 194, specifically to the skin,” par. 169), the underlay patch comprising an access portion; wherein a wearable analyte monitoring device is configured to be disposed on top of the underlay patch (Figs. 7-16), and wherein the access portion of the underlay patch enables an analyte sensor of the wearable analyte monitoring device to extend through the access portion of the underlay patch and insert subcutaneously into the skin of the user to collect analyte data of the user (Figs. 7-16 show the analyte sensor 162 extending through the patch, so there must be an inherent access through the patch).
Regarding claim 23, Gill teaches the one or more sensors comprise at least one of electrodes or photonics (galvanic skin response sensor 320, LEDs/photodiodes 322, Fig. 11).
Regarding claim 24, Gill teaches the apparatus is configured to communicate the physiological data of the user to the wearable analyte monitoring device via a wired or wireless connection with the wearable analyte monitoring device (“The sensor module may communicate with the CGM to transmit data…Communication between the sensor module and the CGM may utilize a direct wired connection. Alternatively, a wireless connection between the sensor module and the CGM may be used,” par. 193).
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.
Claims 1-6, 9, 14-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gill (US 2020/0054258) in view of Fennell (US 2010/0014626).
Regarding claim 1, Gill teaches a system (medical system 150, Figs. 7-8; and/or CGM sensor systems in Figs. 9-16) comprising:
a wearable analyte monitoring device (first subsystem 162 and electronics unit 164; or CGM 342 with electronics component 348) comprising a transmitter (“the electronics unit may specifically be embodied as a transmitter,” par. 47) and an analyte sensor (analyte sensor 184; glucose sensor 350) to obtain analyte data of a user (“an analyte sensor 184 for detecting at least one analyte in a body tissue,” par. 162);
an analyte augmentation wearable (second subsystem 110 or sensor module 344) comprising one or more sensors to obtain additional physiological data for augmenting the analyte data of the user (“The secondary sensor of the second subsystem may be configured for collecting at least one of physiological data, physical data from the host,” par. 40), the analyte augmentation wearable communicably coupled to the wearable analyte monitoring device via a wired or wireless connection (“Communication between the sensor module and the CGM may utilize a direct wired connection. Alternatively, a wireless connection between the sensor module and the CGM may be used,” par. 193); and
a sensor hub implemented at a computing device (“The sensor module and/or the CGM may also communicate with external devices. The sensor module may communicate directly with such devices, or indirectly by way of the CGM…The external devices include dedicated medical device systems, smartphones, PDAs, computers,” par. 194) to obtain both the analyte data and the additional physiological data from at least one of the wearable analyte monitoring device or the analyte augmentation wearable (“the term ‘measurement data’ refers to arbitrary data acquired by using the first subsystem and/or the second subsystem,” par. 54; “transmitting the measurement data via radio transmission to the at least one external device,” par. 59), and augment the analyte data by storing the analyte data in association with the additional physiological data (“tracking of data from the different sensors in a continuous manner and thereby provides more context to the data,” par. 14; “simultaneously collecting this information…where the various sensors form an integrated and coordinated system,” par. 174; different sensors providing data context suggests the sensor data is stored in association).
Gill explicitly teaches or suggests all limitations of claim 1 except for a data packet containing both the analyte data and the additional physiological data. However, the analyte data and the additional physiological data are both transmitted to the external device (“the term ‘measurement data’ refers to arbitrary data acquired by using the first subsystem and/or the second subsystem,” par. 54; “transmitting the measurement data via radio transmission to the at least one external device,” par. 59). Fennell teaches an analogous continuous analyte monitoring system (Abstract, Fig. 1) where data from multiple sensors can be transmitted in a single data packet to a receiver unit (Tables 1-4 and associated description in par. 59-66). For example, analyte sensor data may be transmitted together with temperature sensor data (Table 1; par. 63) and/or second analyte data (Table 2; par. 64).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gill to transmit a data packet including both the analyte data and physiological sensor data. Since Gill does not discuss transmission protocols between the CGM, sensor module, and external devices, one would be motivated to look at known transmission protocols in the prior art, such as Fennell’s Tables 1 and 2. Such a transmission protocol would allow for continuous transmission of important sensor data while minimizing transmission times (“maintaining a minimum transmission time window…time sensitive immediate data (for example, the analyte sensor data, temperature data etc), may be transmitted over the communication link substantially in its entirety with each data packet,” Fennell par. 77). This would further be helpful for simultaneous and continuous monitoring of multiple sensors, which is an objective of Gill (“tracking of data from the different sensors in a continuous manner and thereby provides more context to the data,” par. 14).
Regarding claim 2, Gill teaches the additional physiological data describes at least one of an additional analyte of the user or one or more physiological signals of the user (“The secondary sensor of the second subsystem may be configured for collecting at least one of physiological data, physical data from the host,” par. 40; “other sensor units may gather, often simultaneously, patient data points including body motion, skin temperature, skin conduction, heart rate, and blood oxygen,: par. 172).
Regarding claim 3, Gill teaches the analyte augmentation wearable has a first form factor that is complementary to a second form factor of the wearable analyte monitoring device (Figs. 5, 7, 9-16).
Regarding claim 4, Gill teaches the analyte augmentation wearable includes at least one of:
an access that allows the analyte sensor of the wearable analyte monitoring device to pass through the access and into skin of the user (Figs. 7A-7B show that first subsystem 162 extends through the patch comprising second subsystem 110; CGM 304 includes a glucose sensor which extends through the skin and would have to pass through the patch and an inherent access on the bottom of sensor module 308 comprising sensors 322 and 324 as shown in Figs. 9-11 and described in par. 175-176);
an access that fits around the wearable analyte monitoring device such that the analyte augmentation wearable can be applied to skin of the user around the wearable analyte monitoring device (Figs. 5A-5B show the second subsystem 110 fits partially around the electronics unit 164);
a partial cavity having a complementary shape to the wearable analyte monitoring device such that a portion of the wearable analyte monitoring device fits within the partial cavity of the analyte augmentation wearable and such that the portion of the wearable analyte monitoring device is covered when applied while another portion of the wearable analyte monitoring device is exposed (Figs. 5A-5B; Figs. 9-10 show the arms 314 of sensor module 308 partially covering CGM 304; Figs. 12-16 show how sensor modules 344 and 378 partially cover components of CGM 342 and CGM 372, respectively).
Regarding claim 5, Gill teaches the analyte augmentation wearable includes one or more components that physically contact at least a portion of the wearable analyte monitoring device when the analyte augmentation wearable and the wearable analyte monitoring device are worn by the user (Figs. 5, 7, 9-16).
Regarding claim 6, Gill teaches the analyte augmentation wearable comprises an underlay patch that is configured to be disposed at least partially between the wearable analyte monitoring device and skin of the user (Figs. 7-16).
Regarding claim 9, Gill in view of Fennell further teaches the wearable analyte monitoring device is further configured to: obtain the additional physiological data from the analyte augmentation wearable via the wired or wireless connection (“The sensor module may communicate with the CGM to transmit data,” Gill par. 193); form the data packet containing both the analyte data and the additional physiological data (“the transmitter data packet may be configured to provide or transmit analyte sensor data from two or more independent analyte sensors,” Fennell par. 64; Fennell Tables 1-2); and transmit the data packet containing both the analyte data and the additional physiological data to the sensor hub using the transmitter (“transmitting the measurement data via radio transmission to the at least one external device,” Gill par. 59; “The sensor module and/or the CGM may also communicate with external devices. The sensor module may communicate directly with such devices, or indirectly by way of the CGM,” Gill par. 194; “the one or more receiver units 104, 106 may be configured to parse the received data packet,” Fennell par. 59).
Regarding claim 14, Gill teaches a computer-implemented method (“the analyte measurement device may comprise as least one evaluation unit comprising at least one data processing device, such as a microcontroller,” par. 61) comprising:
obtaining analyte data of a user by an analyte sensor of a wearable analyte monitoring device (first subsystem 162 and electronics unit 164; or CGM 342 with electronics component 348) worn by the user (“an analyte sensor 184 for detecting at least one analyte in a body tissue,” par. 162);
obtaining additional physiological data for augmenting the analyte data of the user by one or more sensors (“The secondary sensor of the second subsystem may be configured for collecting at least one of physiological data, physical data from the host,” par. 40) of an analyte augmentation wearable (second subsystem 110 or sensor module 344), the analyte augmentation wearable communicably coupled to the wearable analyte monitoring device via a wired or wireless connection (“Communication between the sensor module and the CGM may utilize a direct wired connection. Alternatively, a wireless connection between the sensor module and the CGM may be used,” par. 193);
obtaining, by a sensor hub implemented at a computing device(“The sensor module and/or the CGM may also communicate with external devices. The sensor module may communicate directly with such devices, or indirectly by way of the CGM…The external devices include dedicated medical device systems, smartphones, PDAs, computers,” par. 194), the analyte data and the additional physiological data from at least one of the wearable analyte monitoring device or the analyte augmentation wearable (“transmitting the measurement data via radio transmission to the at least one external device,” par. 59; “the term ‘measurement data’ refers to arbitrary data acquired by using the first subsystem and/or the second subsystem,” par. 54); and
augmenting the analyte data by storing the analyte data in association with the additional physiological data (“tracking of data from the different sensors in a continuous manner and thereby provides more context to the data,” par. 14; “simultaneously collecting this information…where the various sensors form an integrated and coordinated system,” par. 174; continuous tracking, context, and simultaneous collection suggests that the data is stored in a way such that they can be associated and analyzed together).
Gill explicitly teaches or suggests all limitations of claim 14 except for a data packet containing both the analyte data and the additional physiological data. However, the analyte data and the additional physiological data are both transmitted to the external device (“the term ‘measurement data’ refers to arbitrary data acquired by using the first subsystem and/or the second subsystem,” par. 54; “transmitting the measurement data via radio transmission to the at least one external device,” par. 59). Fennell teaches an analogous continuous analyte monitoring system (Abstract, Fig. 1) where data from multiple sensors can be transmitted in a single data packet to a receiver unit (Tables 1-4 and associated description in par. 59-66). For example, analyte sensor data may be transmitted together with temperature sensor data (Table 1; par. 63) and/or second analyte data (Table 2; par. 64).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gill to transmit a data packet including both the analyte data and physiological sensor data. Since Gill does not discuss transmission protocols between the CGM, sensor module, and external devices, one would be motivated to look at known transmission protocols in the prior art, such as Fennell’s Tables 1 and 2. Such a transmission protocol would allow for continuous transmission of important sensor data while minimizing transmission times (“maintaining a minimum transmission time window…time sensitive immediate data (for example, the analyte sensor data, temperature data etc), may be transmitted over the communication link substantially in its entirety with each data packet,” Fennell par. 77). This would further be helpful for simultaneous and continuous monitoring of multiple sensors, which is an objective of Gill (“tracking of data from the different sensors in a continuous manner and thereby provides more context to the data,” par. 14).
Regarding claim 15, Gill teaches the analyte augmentation wearable has a first form factor that is complementary to a second form factor of the wearable analyte monitoring device (Figs. 5, 7, 9-16).
Regarding claim 16, Gill in view of Fennell teaches obtaining, by the wearable analyte monitoring device, the additional physiological data from the analyte augmentation wearable via the wired or wireless connection (“The sensor module may communicate with the CGM to transmit data,” Gill par. 193); forming the data packet containing both the analyte data and the additional physiological data (“the transmitter data packet may be configured to provide or transmit analyte sensor data from two or more independent analyte sensors,” Fennell par. 64; Fennell Tables 1-2); and transmitting the data packet containing both the analyte data and the additional physiological data to the sensor hub using a transmitter (“the electronics unit may specifically be embodied as a transmitter,” par. 47) of the wearable analyte monitoring device (“transmitting the measurement data via radio transmission to the at least one external device,” Gill par. 59; “The sensor module and/or the CGM may also communicate with external devices. The sensor module may communicate directly with such devices, or indirectly by way of the CGM,” Gill par. 194; “the one or more receiver units 104, 106 may be configured to parse the received data packet,” Fennell par. 59).
Regarding claim 18, Gill teaches a method implemented by a wearable analyte monitoring device (first subsystem 162 and electronics unit 164, Figs. 5, 7-8; or CGM 342 with electronics component 348, Figs. 9-16) worn by a user, the method comprising:
establishing a first wired or wireless connection with a sensor hub implemented at a computing device associated with the user (“the CGM may also communicate with external devices…these communications may be by hard wire or wirelessly. The external devices include dedicated medical device systems, smartphones, PDAs, computers,” par. 194) and establishing a second wired or wireless connection with an analyte augmentation wearable (second subsystem 110 or sensor module 344) worn by the user (“Communication between the sensor module and the CGM may utilize a direct wired connection. Alternatively, a wireless connection between the sensor module and the CGM may be used,” par. 193);
collecting analyte data of the user via an analyte sensor of the wearable analyte monitoring device worn by the user (“an analyte sensor 184 for detecting at least one analyte in a body tissue,” par. 162);
obtaining additional physiological data from the analyte augmentation wearable worn by the user via the second wired or wireless connection (“The sensor module may communicate with the CGM to transmit data,” Gill par. 193);
communicating the both the analyte data collected by the analyte sensor of the wearable analyte monitoring device and the additional physiological data obtained from the analyte augmentation wearable to the sensor hub via the first wired or wireless connection (“the term ‘measurement data’ refers to arbitrary data acquired by using the first subsystem and/or the second subsystem,” par. 54; “transmitting the measurement data via radio transmission to the at least one external device,” par. 59).
Gill teaches all limitations of claim 18 except for packaging the analyte data with the additional physiological data to form an augmented analyte packet. However, the analyte data and the additional physiological data are both transmitted to the external device (“the term ‘measurement data’ refers to arbitrary data acquired by using the first subsystem and/or the second subsystem,” par. 54; “transmitting the measurement data via radio transmission to the at least one external device,” par. 59). Fennell teaches an analogous continuous analyte monitoring system (Abstract, Fig. 1) where data from multiple sensors can be transmitted in a single data packet to a receiver unit (Tables 1-4 and associated description in par. 59-66). For example, analyte sensor data may be transmitted together with temperature sensor data (Table 1; par. 63) and/or second analyte data (Table 2; par. 64).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gill to transmit a data packet including both the analyte data and physiological sensor data. Since Gill does not discuss transmission protocols between the CGM, sensor module, and external devices, one would be motivated to look at known transmission protocols in the prior art, such as Fennell’s Tables 1 and 2. Such a transmission protocol would allow for continuous transmission of important sensor data while minimizing transmission times (“maintaining a minimum transmission time window…time sensitive immediate data (for example, the analyte sensor data, temperature data etc), may be transmitted over the communication link substantially in its entirety with each data packet,” Fennell par. 77). This would further be helpful for simultaneous and continuous monitoring of multiple sensors, which is an objective of Gill (“tracking of data from the different sensors in a continuous manner and thereby provides more context to the data,” Gill par. 14).
Regarding claim 19, Gill in view of Fennel further teaches communicating the augmented analyte packet containing both the analyte data and the additional physiological data to the sensor hub at predefined intervals (“a packet transmission at approximately 60 second intervals,” Fennell par. 70).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gill in view of Fennell, as applied to claim 1 above, and further in view of Burnette (US 2017/0181628).
Gill in view of Fennel do not explicitly teach or suggest the analyte augmentation wearable is further configured to compress the additional physiological data and transmit compressed additional physiological data to the wearable analyte monitoring device. Gill does teach that the analyte augmentation wearable has data processing, power supply, and transmission functions (“the second subsystem may comprise at least one second subsystem data communication device which is configured to transfer data…the second subsystem comprises…a data processing device, a data storage device, and an electronics power supply,” par. 56;). Burnette teaches an analogous analyte sensing system (Fig. 1). Burnette teaches that data compression allows for smaller transmissions which reduces battery usage (par. 152).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Gill in view of Fennel to configure the analyte augmentation wearable to compress the additional physiological data before transmission. One would be motivated to do so in order to reduce the transmission size and power usage of the analyte augmentation wearable, as suggested by Burnette (par. 152). Although Burnette teaches compression of analyte data, one would expect that compression of the additional physiological data would lead to the same advantages in the second subsystem comprising a power supply and communication device.
Conclusion
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/ALICE LING ZOU/ Examiner, Art Unit 3791