DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on January 23, 2026 were received and fully considered. No claims were amended. Claims 40-42 are new. Please see corresponding rejection headings and response to arguments section below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 23, 2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 29, 5, 7-9, 12, 14, 16-18, 20, 22, 23, and 30-39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bonnecaze et al. (US PG Pub. No. 2003/0100040 A1) (hereinafter “Bonnecaze”) in view of Brenneman et al. (US PG Pub. No. 2008/0092638 A1) (hereinafter “Brenneman”).
Bonnecaze was applied in the previous office action.
With respect to claim 29, Bonnecaze teaches a system for in-vivo measurement of an analyte concentration in a human or animal body (abstract “determine blood glucose concentration from measurements… in vivo”), comprising:
an implantable sensor configured to generate a measuring signal correlated to the analyte concentration to be measured (abstract “subcutaneously implanted sensing device, such as electrochemical sensor, is used to make the measurements”; transcutaneous, i.e. implantable, on-skin sensor control unit 44 as depicted in Fig. 17);
a remote device configured to wirelessly transmit a control signal comprising a source identity signal unique to the remote device and instructions to send measurements to the remote device (receiver 46 transmits/receives signals to/from the implantable sensor 44 as depicted in Fig. 17; see also par.0267 “transmitter 98 for transmitting the sensor signals… to a receiver/display unit 46”; par.0330 “transmitter 98 may also transmit a code… to identify, one on-skin control unit 44”; par.0332 “Another method to eliminate ‘crosstalk’, which is typically used in conjunction with the identification code or encryption scheme, includes providing an optional mechanism in the on-skin sensor control unit 44 for changing transmission frequency or frequency bands upon determination that there is ‘crosstalk’… the receiver/display unit 46… transmits a signal to the optional receiver 99 on the on-skin control unit 44 to direct the transmitter of the on-skin sensor control unit 44 to change frequency or frequency band”);
a base station operably coupled to the implantable sensor, comprising:
a potentiostat configured to supply voltage to the implantable sensor (par.0274 “sensor circuit 97 typically includes a potentiostat that provides a constant potential to the sensor 47”; see Figs. 18A-18B);
a base receiver configured to receive the unique source identity signal to identify the remote device (transmitter 98 of the on-skin control unit 44 receives unique identification code from remote device 46; see Figs. 18A-18B; par.0266-0267, 0330+ “identification code may be… communicated to the sensor control unit 44 via a transmitter… coupled to the sensor control unit”) and thereby determine whether to communicate with the remote device or ignore the remote device (par.0332; Note: on-skin control unit 44 determines whether to communicate with the remote device upon changing transmission frequency or frequency bands, all other remote devices that do not match the required frequency change based upon determination that there is crosstalk are ignored);
a base transmitter configured to wirelessly transmit data to the remote device when the base receiver receives the control signal (transmitter 98 of on-skin sensor control unit 44 wirelessly transmits data to the receiver 46 when the frequency or frequency band is changed; see par.0332, also indicated by the directional arrow in Fig. 17) with an expected identifier (par.0330-0333 “unique identification code”); and
However, Bonnecaze does not explicitly teach wherein the remote device confirms receipt of the data by transmitting a confirmation signal.
Brenneman teaches the remote device confirms receipt of the data by transmitting a confirmation signal (abstract “remote monitoring device adapted to wirelessly communicate with the sensor module… transmit a signal to the sensor module confirming that the analyte-concentration information was received”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) at the time of invention to modify Bonnecaze’s remote device 46 to transmit a confirmation signal, in the manner recited, in order to confirm that analyte-concentration information was received, as evidence by Brenneman (see abstract). Additionally, Bonnecaze recognizes that further action may be needed in the event that there is “crosstalk” (presence of other remote devices that may create noise or interference), which include additional steps comprising automatically or manually transmitting additional signals for changing frequency or frequency bands from the remote device 46 to the implantable sensor 44 upon detection of the possibility of interference from other remote devices (par.0332-0333). This additional communication step (from remote device to implantable sensor) provides added motivation to look to other analyte monitoring systems that establish transmitting signals from a remote device, which include transmitting a confirmation signal as in Brenneman. Lastly, PHOSITA would have had predictable success combining Bonnecaze and Brenneman since both teachings relate to the same narrow field of endeavor, i.e. wireless analyte monitoring with the use of remote devices.
With respect to claim 5, Bonnecaze teaches the remote device comprises a display device remote from the base station and configured to transmit the control signal to the base receiver (Figs. 17 and 22).
With respect to claim 7, Bonnecaze teaches the replaceable sensor carrier is configured to wirelessly communicate with the base station (Figs. 18, 17, and 22; par.0230 “no wires to other electronic components or other devices”).
With respect to claim 8, Bonnecaze teaches the wireless communication between the replaceable sensor carrier and the base station occurs inductively (par.0263).
With respect to claim 9, Bonnecaze does not explicitly teach wherein the wireless communication between the replaceable sensor carrier and the base station occurs by RFID. However, Bonnecaze teaches wireless communication between on-skin sensor control unit and other electronic components or other devices (par.0230). Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to utilize communication by widely known RFID as this would be simple substitution.
With respect to claim 12, Bonnecaze teaches wherein the implantable sensor is activated by coupling with the base station such that the implantable sensor commences to supply the measuring signal, and wherein a command is generated by a processor in the base station upon connecting the replaceable sensor carrier to the base station (par.0240, 0344).
With respect to claim 14, Bonnecaze teaches wherein the base station memory includes status information comprised of at least one of a charge status of a battery and a result of an internal functional test, and the status information is configured to be stored in the base station memory with the stored measuring signal, and wherein the status information is stored as a status code (par.0319).
With respect to claim 16, Bonnecaze teaches the display device further comprising a measuring unit for separately determining concentration values of the same analyte measured by the implantable sensor, wherein an analytical unit of the display device is connected to the measuring unit, and the analyte concentration values obtained from the measuring unit are used to calibrate the measuring signal obtained from the implantable sensor (par.0270, 0297+).
With respect to claim 17, Bonnecaze teaches the base station comprises a test circuit that is connected to the potentiostat and supplies a response signal to a base station analytical unit during a system test, and wherein the response signal is analyzed by the base station analytical unit, and wherein the base station analytical unit is configured to compare a value of the response signal to an expected value and generate an error signal if the value of the response signal deviates from the expected value by more than a predetermined tolerance value, and wherein the error signal is transmitted to the display device, and the display device is configured to provide the error signal to a user (par.0215, 0274, 0283, 0319+).
With respect to claim 18, Bonnecaze teaches wherein the test circuit is configured to simulate a sensor connected to the potentiostat such that the base station analytical unit is configured to use the test circuit to determine a function of the potentiostat and a charging status of a battery (par.0240, 0274).
With respect to claim 20, Bonnecaze teaches wherein the display device has a higher computing capacity than the base station, whereby cost of the base station can be reduced (Fig. 22; par.0323).
With respect to claim 22, Bonnecaze does not explicitly teach wherein the data carrier is an electronic memory configured to be written and/or read using RFID. However, Bonnecaze teaches wireless communication between on-skin sensor control unit and other electronic components or other devices (par.0230). Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to utilize communication by widely known RFID as this would be simple substitution.
With respect to claim 23, Bonnecaze teaches wherein the base station contains a memory in which the measuring signal is stored, and wherein the stored measuring signal includes a check code configured to recognize data corruption and erroneous measurements in the stored measuring signal (par.0330+).
With respect to claim 30, Bonnecaze suggests when there are multiple control signals with a matching source identity signal, subsequent control signals with the matching source identity signal will trigger the base station to transmit only data received after an immediately preceding control signal with the matching source identity signal, whereby transmission time and transmission energy can be reduced (par.0330+ “unique identification code” suggests needing to match the code and that subsequent codes are utilized prior to data transmission, which thereby would reduce transmission time/energy, i.e. data is only transmitted to the remote device upon there being a matched code).
With respect to claim 31, Bonnecaze teaches the implantable sensor is part of a replaceable sensor carrier that comprises a sealed housing in which the implantable sensor is disposed, and the sealed housing is configured to couple with the base station such that the implantable sensor is coupled to the base station (par.0214 “sensor 42 may be designed to be a replaceable component in an in vivo analyte monitor, and particularly in an implantable analyte monitor. sensor 42 may be designed to be a replaceable component in an in vivo analyte monitor, and particularly in an implantable analyte monitor”).
With respect to claim 32, Bonnecaze teaches the replaceable sensor carrier contains a data carrier having calibration data of the implantable sensor (par.0270, 0297+).
With respect to claim 33, Bonnecaze teaches the data carrier is inside the sealed housing and the data carrier is configured such that the calibration data is written through the sealed housing (par.0270, 0297+).
With respect to claim 34, Bonnecaze teaches the base station further comprises a memory, a signal processor, an analytical unit, and a communication unit, and the communication unit includes the base transmitter and the base receiver, and the signal processor is configured to compress the measuring signal, and the compressed measuring signal is stored in the memory, and both the analytical unit and the communication unit are configured to access the memory, and wherein the analytical unit and the communication unit are connected to the memory by a changeover switch, and the changeover switch is configured to connect the memory and one of the analytical unit and the communication unit in response to a status of the switch (see Fig. 18B).
With respect to claim 35, Bonnecaze teaches the base station is configured to transmit a second characteristic identifier signal identifying the base station (Fig. 18B, par.0330+).
With respect to claim 36, Bonnecaze teaches a system for in-vivo measurement of an analyte concentration in a human or animal body, comprising: an implantable sensor configured to generate a measuring signal correlated to the analyte concentration to be measured; a remote device configured to wirelessly transmit a control signal comprising a source identity signal unique to the remote device and instructions to send measurements to the remote device; a base station operably coupled to the implantable sensor, comprising: a potentiostat configured to supply voltage to the implantable sensor; a base receiver configured to receive the unique source identity signal and use the unique source identity signal to identify the remote device; a base transmitter configured to wirelessly transmit data to the remote device when the base receiver receives the control signal (see rejection of claim 29 above); and a signal processor configured to execute instructions for processing the measuring signals to produce measurement data and a memory (par.0305 “optional data storage unit 102… from the processing circuit 109… so that the data can be used by the processing circuit 109 to analyze and/or predict trends in the analyte level, including, for example, the rate and/or acceleration of analyte level increase or decrease.”).
However, Bonnecaze does not explicitly teach the measurement data is stored wherein the memory is configured to permit over-writing of measuring data only after the measuring data have been transmitted to the remote device and the base station receives a confirmation signal from the remote device
Brenneman teaches the remote device confirms receipt of the data by transmitting a confirmation signal (abstract “remote monitoring device adapted to wirelessly communicate with the sensor module… transmit a signal to the sensor module confirming that the analyte-concentration information was received”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) at the time of invention to modify Bonnecaze’s remote device 46 to transmit a confirmation signal, in the manner recited, in order to confirm that analyte-concentration information was received, as evidence by Brenneman (see abstract). Additionally, Bonnecaze recognizes that further action may be needed in the event that there is “crosstalk” (presence of other remote devices that may create noise or interference), which include additional steps comprising automatically or manually transmitting additional signals for changing frequency or frequency bands from the remote device 46 to the implantable sensor 44 upon detection of the possibility of interference from other remote devices (par.0332-0333). This additional communication step (from remote device to implantable sensor) provides added motivation to look to other analyte monitoring systems that establish transmitting signals from a remote device, which include transmitting a confirmation signal as in Brenneman. Lastly, PHOSITA would have had predictable success combining Bonnecaze and Brenneman since both teachings relate to the same narrow field of endeavor, i.e. wireless analyte monitoring with the use of remote devices. Although Bonnecaze does not explicitly teach the measurement data is stored wherein the memory is configured to permit over-writing of measuring data only after the measuring data have been transmitted to the remote device, such a modification would have been prima facie obvious to PHOSITA at the time of invention for several reasons. Bonnecaze expressly teaches “an optional data storage unit 102 which may be used to hold data… from the processing circuit 109 permanently or, more typically, temporarily” (par.0267; par.0305). Thus, PHOSITA would have had predictable modifying Bonnecaze at the time of invention to permit temporary storage of data (over-writing of previously stored measuring data) after first receiving confirmation from the remote device (changing frequency upon determining that there is potential crosstalk), as suggest by Bonnecaze (par.0267, 0305, 0332-0333).
With respect to claim 37, Bonnecaze does not expressly teach wherein the remote device is a data and communication center which communicates with at least one additional system component. However, further modifying Bonnecaze such that the remote device is a data and communication center would have been prima facie obvious to PHOSITA at the time of invention as data and communication centers (e.g. hospital servers) are widely known as alternative sources for receiving medical data. Moreover, Bonnecaze teaches, in other embodiments, that the remote device can be in at hospital, at a nurse’s station, etc. (see par.0329).
With respect to claim 38, Bonnecaze teaches wherein the at least one additional system component includes an injection device (par.0355 “used to control and adjust the administration of insulin”, which suggests an injection device; see also par.0362 “insulin injections”).
With respect to claim 39, Bonnecaze teaches wherein the replaceable sensor carrier transmits a first characteristic identifier which identifies the replaceable sensor carrier and the base station transmits a second characteristic identifier which identifies the base station (par.0332-0333).
With respect to claim 40, Bonnecaze teaches wherein the memory in which the measurement data is stored (par.0267 “data storage unit 102 for temporarily or permanently storing data from the processing circuit 109”). Although Bonnecaze does not expressly teach an EEPROM or flash memory and the base station includes a RAM memory for storage of raw data, further modification to incorporate other known data storage devices would only require routine skill in the art, as a simple substitution.
Claims 41 and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bonnecaze and Brenneman, as applied to claim 36 above, in further view of Thede et al. (US PG Pub. No. 2003/0158487 A1) (hereinafter “Thede”).
With respect to claim 41, Bonnecaze and Brenneman teach a system for in-vivo measurement of an analyte concentration in a human or animal body, as established above. Brenneman also suggests the base station is configured to effect transmission of existing measuring data and receive a confirmation signal from the remote device before recording new measuring data (abstract “remote monitoring device adapted to wirelessly communicate with the sensor module… transmit a signal to the sensor module confirming that the analyte-concentration information was received”).
However, Bonnecaze and Brenneman do not teach wherein the base station is detachably coupled to the implantable sensor and, when the implantable sensor is replaced by a new implantable sensor.
Thede teaches wherein the base station is detachably coupled to the implantable sensor and… the implantable sensor is replaced by a new implantable sensor (par.0039 “sensing unit 28 can be individually detached from base unit 26… and replaced by another sensing unit”).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Bonnecaze and Brenneman such that the the base station is detachably coupled to the implantable sensor and the implantable sensor is replaced by a new implantable sensor in the event the sensing unit is contaminated or damaged, as evidence by Thede (par.0052). Bonnecaze further discloses the need to replace the sensors (e.g. when electrodes are not within a desired level of tolerance; see par.0279), thereby providing added motivation for PHOSITA to look to other teachings that set forth replacing sensors as recited (e.g. Thede).
With respect to claim 42, Brenneman suggests wherein the base station acquires the state date and time of day for the new implantable sensor from the remote device and stores it in a data header for the new measuring data (par.0038+). Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to acquire/store state date and time of day information, in the manner recited, in order to keep track of what data is transmitted from the sensor module 12 to the remote monitoring device 14, as evidence by Brenneman (par.0038+).
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been fully considered. While Examiner does not necessarily agree with applicant’s remarks pertaining to the previous obviousness rejections (Bonnecaze), for the interests of compact prosecution Examiner introduces new obviousness rejections (Bonnecaze in view of Brenneman). Please see prior art section above for more detail, updated citations (new Brenneman reference), and updated obviousness rationale.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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