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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The original specification does not appear to have support for the modified sensor context information to include glucose data. It is also not apparent why the glucose data would have to be modified or in what way. Clarification is requested. If pass-through inclusion is intended (glucose not changed): consider clarifying with wording such as “includes glucose data received…” If actual processing is intended: add “processed/converted/adjusted” to glucose data and point to disclosure for support.
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) 1-11 and 14-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamath (US 2019/0125224) in view of Say (US 6,565,509).
Regarding claims 1 and 16, Kamath teaches a system (Figs. 1, 2A-2B, 7D, 9A) for managing a glucose level of a user, the system comprising:
a glucose sensor (10) comprising a proximal and a distal portion, wherein the glucose sensor is configured to be inserted in contact with a bodily fluid under a skin layer of the user (“a subcutaneous, transdermal (e.g., transcutaneous), or intravascular device,” par. 213), wherein the glucose sensor is configured to generate raw data signals corresponding to measurements of the glucose level in the bodily fluid (“analyte sensor 10 can…provide a data stream indicative of the concentration of glucose in a host. The data stream is typically a raw data signal,” par. 214);
sensor electronics (12) electrically coupled to the glucose sensor (“sensor electronics module 12 can be physically connected to continuous analyte sensor 10,” par. 188), the sensor electronics comprising a memory storing one or more predetermined characteristics associated with the sensor electronics (storage 515 with configuration parameters 520, Fig. 3C; par. 224), wherein the sensor electronics are in electronic communication with the glucose sensor (“sensor electronics module 12 that is typically physically connected to continuous analyte sensor 10…sensor electronics module 12 includes electronics configured to process a data stream associated with an analyte concentration measured by continuous analyte sensor 10,” par. 211);
a receiving device (any display device 110, 120, 130, 140 in Fig. 1; and/or display devices 310 or 910); and
a plurality of external devices (partner devices 136, 315, and/or 915), wherein each external device is configured for wireless communication with the receiving device and the sensor electronics (Figs. 2A-2B; “display devices 310 and/or partner devices 315 (and/or a plurality of either device) can be in connection with analyte sensor system 308 using different connection models,” par. 330; “partner device 315 and display device 310 may maintain communication via connection C,” par. 333),
wherein a first external device [0391-93; e.g., old device 915a] of the plurality of external devices stores sensor context information [0224, 0245, 0251+; e.g., configuration parameters, analyte dosage data], and the first external device is configured to:
receive sensor data from the sensor electronics [0008, 0019, 0059, 0073, 0210+; analyte sensor system receives input from a partner device via the diabetes management partner interface];
modify the sensor context information based on the sensor data received from the sensor electronics [0059, 0073; analyte sensor system may receive from the partner device a value for one of the configuration parameters and modify the configuration parameter using the value received from the partner device; 0391-93: transferred bonding, key, timing, and related state information are modified sensor context information]; and
communicate the modified sensor context information to the receiving device [e.g., mobile phone 910],
wherein the receiving device communicates the modified sensor context information to a second external device [e.g., new device 915a] of the plurality of external devices [0391+].
Kamath explicitly teaches all limitations of claims 1 and 16 except particular details of the glucose sensor wherein the distal portion comprises a plurality of electrodes, a glucose-responsive enzyme, and a glucose flux regulating membrane, and the proximal portion being electrically connected to the sensor electronics. Kamath does indicate that the sensor can be any device capable of glucose level measurements and references several other patent publications, including Say (pars. 213-216).
Say teaches an analogous glucose sensor (Abstract) comprising a proximal portion (proximal end 65) and a distal portion (distal end 67), wherein the distal portion comprises a plurality of electrodes (working electrodes 58 and counter/reference electrode 60, Fig. 2), a glucose-responsive enzyme (“first sensing layer 64 which is spaced apart from the working electrode and contains an enzyme, for example, glucose oxidase,” col. 17, lines 41-43), and a glucose flux regulating membrane (“mass transport limiting layer 74 may be included with the sensor to act as a diffusion-limiting barrier to reduce the rate of mass transport of the analyte,” col. 26, lines 2-4), and the proximal portion being electrically connected to the sensor electronics (“sensor 42 and the electronic components within the on-skin sensor control unit 44 are coupled via conductive contacts 80, as shown in FIGS. 14-16…The placement of the conductive contacts 80 is such that they are in contact with the contact pads 49 on the sensor 42 when the sensor 42 is properly positioned within the on-skin sensor control unit 44,” col. 34, lines 31-45).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kamath to use Say’s glucose sensor. One would be motivated to do so because Kamath teaches that the sensor may be Say’s sensor (Kamath par. 216), and Say’s sensor arrangement was known in the art. Since Kamath teaches using Say’s sensor, one could expect to successfully carry out Kamath’s system with Say’s sensor. Thus, Kamath in view of Say teaches or suggests all limitations of claims 1 and 16.
Regarding claims 2 and 20, Kamath teaches the first external device is configured to package the modified sensor context information into a format configured to be uploaded by the second external device to the receiving device (“display device 110, 120, 130, 140 may receive analyte data from analyte sensor system 8 indirectly via another device (e.g., partner device 136 and/or server system 134),” par. 238; 0391-93: since the data and other information may be sent and received among the display devices and partner devices, the data must be in a compatible format).
Regarding claim 3, Kamath teaches the first external device is configured to transfer the sensor context information to the receiving device (“display device 110, 120, 130, 140 may receive analyte data from analyte sensor system 8 indirectly via another device (e.g., partner device 136 and/or server system 134),” par. 238), and the receiving device is configured to package the sensor context information into a format configured to be uploaded by the second external device (Fig. 2A shows display device 310, partner device(s) 315, and server 334a are communicatively coupled and can transfer information via communication media 305) [0391-93].
Regarding claims 4 and 18, Kamath teaches the sensor context information includes encryption information for authentication between the first external device and the sensor electronics (“such an application key may effectively be shared between analyte sensor system 308 and display device 310 and/or partner device 315,” par. 304; “partner devices 315” includes one or more partner devices, par. 195) [0385].
Regarding claims 5 and 19, Kamath teaches the sensor context information includes communication information for establishing a direct wireless connection between the sensor electronics and each external device of the plurality of external devices (“mobile phone 910a can send bonding data information from old medicament delivery device 915a to new medicament delivery device 915a, such that new medicament delivery device 915a may use the bonding data for facilitating connection establishment with analyte sensor system 308…medicament delivery device 915a may use the information regarding old medicament delivery device 915a…to replicate the GAPP address, encryption and security keys, other bonding information, and/or timing information (e.g., regarding timing of connections, advertisement intervals etc.), as employed by old medicament delivery device 915a,” par. 392).
Regarding claims 6 and 7, Kamath teaches the sensor context information includes configuration or calibration parameters for converting the raw data signals of the glucose sensor and generating calibrated glucose levels (“configuration parameters 520 include one or more of access control parameters for display devices 910, 910′ (e.g., mobile phone 910a) and/or partner devices 915 (e.g., medicament delivery device 915a), accuracy or calibration parameters for analyte sensor system 308, and wireless communication parameters for communications to be exchanged between/among analyte sensor system 308 and one or more display devices 910, 910′ and partner devices 915,” par. 415).
Regarding claim 8, Kamath teaches the sensor context information includes a compilation of data communicated between the glucose sensor and the first exteral device (“partner device 315 may also include processor/microcontroller 630 that may be coupled to a radio unit or transceiver 610 for sending/receiving sensor data and requests and commands and other signaling to/from an external device, such as…analyte sensor system 308 and/or another partner device 315,” par. 270).
Regarding claim 9, Kamath teaches each external device has a use period of 3-4 days (par. 389).
Regarding claim 10, Kamath teaches the glucose sensor has a use period of 13-15 days (par. 227).
Regarding claims 11 and 17, Kamath teaches each external device is an insulin pump (par. 183; Fig. 9A).
Regarding claim 14, Kamath teaches the receiving device is a smartphone or a smartwatch (smartphone 120 or smartwatch 140, Fig. 1).
Regarding claim 15, Kamath teaches each external device is configured for wireless communication with the receiving device and the sensor electronics via a Bluetooth® communication protocol (par. 197).
Regarding claim 21, Kamath discloses wherein the modified sensor context information comprises glucose data received by the first external device [0127; pass through glucose data]. It would have been obvious to include the analyte/glucose data along with the modified sensor context information for efficient transmission.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kamath in view of Say, as applied to claim 11 above, and further in view of US 2021/0260289, hereinafter Escobar.
Regarding claim 12, Kamath teaches an embodiment of the insulin pump and suggests that different medication delivery device configurations may be used (Fig. 5A; “one example of partner device 136 is an insulin pump. Another example of partner device 136 is an insulin pen,” par. 263) but does not explicitly teach or suggest the insulin pump is a tubeless wearable patch pump.
Escobar teaches an analogous glucose monitoring system comprising a glucose sensor in communication with a insulin pump (Fig. 4). Escobar teaches that the insulin pump may be a tubeless wearable patch pump (Fig. 3; par. 58).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the partner devices of Kamath in view of Say to comprise tubeless wearable patch pumps. One would be motivated to do so because Kamath suggests that the partner devices may comprise different configurations or medical devices (Kamath pars. 266), and a tubeless wearable patch pump was one type of insulin pump known in the art, as shown by Escobar (Figs. 3-4, par. 58).
Regarding claim 13, Kamath in view of Say teaches the receiving device is configured to provide medication delivery instructions to the plurality of external devices (“Application 425b may process and/or present medicament-related and other partner device or system data received by or sent from display device 310…Additionally, application 425b may be used to obtain, access, display, control, and/or interface with medicament, analyte, and/or other data and related messaging and processes associated with partner device 315,” par. 251); however, the instructions are not part of a hybrid closed-loop algorithm.
Escobar teaches an analogous glucose monitoring system comprising a glucose sensor in communication with a insulin pump (Fig. 4). Escobar teaches the pump may be controlled by a hybrid closed-loop algorithm executed by a smartphone (“the artificial pancreas algorithm 416 and the pump control module 418 may operate in different modes from the wearable glucose monitoring device 104, including…a partially closed loop mode (e.g., where the person 102 delivers bolus insulin doses for meals),” par. 267; computing device 108 is a smartphone, Fig. 4).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the display device of Kamath in view of Say to execute a hybrid closed-loop algorithm to provide medication delivery instructions to the plurality of external devices. One would be motivated to do so in order to provide control over the medication delivery based on the measured glucose, and Escobar teaches that hybrid closed-loop algorithms were known in the art to control an insulin pump (Escobar par. 267; Fig. 4). Since Kamath suggests various partner device arrangements (par. 251, 266), configuring Kamath in view of Say in the same way should improve control over insulin delivery.
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground of rejection as exemplified in the following regarding Kamath.
Kamath discloses a system for managing a glucose level of a user, the system including an analyte sensor system having a continuous analyte sensor and sensor electronics, a receiving/display device, and partner or external devices configured for wireless communication in a diabetes-management ecosystem. Kamath teaches that system 100 depicts aspects of analyte sensor system 8 that may be communicatively coupled to display devices, partner devices, and/or server system and that sensor electronics module may be in wireless communication (e.g., directly or indirectly) with one or more of display devices and with partner devices 136. [0186-0187]. Kamath further teaches system in which analyte sensor system, one or more display devices, and/or one or more partner devices exchange wireless communications over communication media, including direct and indirect paths. [0194-0199], [0203-0205]. Thus, Kamath discloses a glucose/analyte-monitoring system architecture including sensor electronics, a receiving device, and a plurality of external devices.
Kamath also discloses sensor electronics electrically coupled to the sensor and comprises memory storing predetermined characteristics associated with the sensor electronics. Kamath teaches that sensor electronics module may include hardware, firmware, and/or software that enables measurement of levels of the analyte via a glucose sensor, and may include signal processing and data storage. [0188]. Kamath further discloses, with greater specificity, that analyte sensor system includes sensor measurement circuitry, processor, radio unit or transceiver, and storage 515 -- expressly stating that storage may store configuration parameters. [0222-0224]. Kamath additionally teaches that those configuration parameters are used by the sensor system for wireless communication, access control, analyte data handling, calibration, and related device interaction. [0010], [0015-0018], [0021], [0026-0029], [0384-0385]. Under the broadest reasonable interpretation, these stored configuration parameters are “predetermined characteristics associated with the sensor electronics.”
Kamath further discloses a receiving device and a plurality of external devices, wherein each external device is configured for wireless communication with the receiving device and the sensor electronics. Kamath teaches that display devices may include a smartphone, smartwatch, and other computing devices, and that partner devices may include insulin delivery devices and other medical devices. [0191-0192], [0196]. Kamath further teaches mesh and gateway arrangements where display device may connect to analyte sensor system, while partner device may also connect to display device and may also connect to analyte sensor system via communication media. [0203-0205]). Kamath also states that display device may be coupled to analyte sensor system and/or partner device via communication media and that partner device may send and receive analyte and medicament-related information through that ecosystem. [0241-0244], [0269-0274]. Accordingly, Kamath discloses the claimed relationship among sensor electronics, a receiving device, and plural external devices configured for wireless communication with both.
Kamath discloses that a first external device stores context-type information associated with continued use of the analyte sensor system and exchanges such information based on received sensor/system data. Kamath teaches that display device storage may store analyte sensor application data, partner device application data, and configuration parameters, and may further store pairing data, analyte-related data, medicament-related data, and information associated with connected partner devices. [0245], [0251-0256]. Kamath also teaches that partner-device-side and display-device-side applications exchange information including pairing data, analyte sensor system information, and medicament delivery information. [0126-0129], [0490-0492]. Under the broadest reasonable interpretation, such stored pairing/configuration/communication/authentication/analyte-data-related information reasonably corresponds to the claimed “sensor context information.”
Kamath further discloses that the first external device receives sensor data from the sensor electronics and modifies or causes modification of stored sensor-system-related information based on that received data and/or according to connected-device requirements. Kamath teaches that the analyte sensor system receives input from a partner device via the diabetes management partner interface and, responsive thereto, setting or causing a modification to the set of configuration parameters. [0008], [0019]. Kamath likewise teaches, in the sixth and seventh aspects, that the analyte sensor system may receive from the partner device a value for one of the configuration parameters and modify the one configuration parameter using the value received from the partner device. [0059], [0073]. Kamath also teaches that analyte data is generated by the sensor system and communicated to connected devices, and that connected applications/devices collect, store, and use that information for further operation and exchange. [0210-0215], [0245], [0251], [0270-0274]. Thus, Kamath teaches receipt of sensor data and modification/use of stored system context information associated with continued sensor-external-device operation.
Kamath additionally discloses communicating such modified context/state information from a first external device to a receiving device, and then from the receiving device to a second external device. Kamath most directly teaches this in its replacement-device migration discussion, where “old medicament delivery device 915a may send data to mobile phone 910a where the data enables analyte sensor system 308 to establish communication with the new medicament delivery device,” and further that “mobile phone 910a can send bonding data information from old medicament delivery device 915a to new medicament delivery device 915a.” Kamath further explains that the new device may use the transferred information “to replicate the GAPP address, encryption and security keys, other bonding information, and/or timing information.” [0391-0393]. Under the broadest reasonable interpretation, the old device is the claimed first external device, the mobile phone is the claimed receiving device, and the new device is the claimed second external device, with the transferred bonding, key, timing, and related state information reasonably reading on the claimed modified sensor context information.
Conclusion
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 Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791
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