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 .
Status of Claims
This office action is responsive to the amendment filed 30 April 2026.
Claims 8-12 are withdrawn.
Claims 1 and 13 are amended.
Claims 1-7 and 13-20 are presently pending in this application.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 13-19, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohm et al. (US Patent Publication No. 20120078071 A1), hereinafter Bohm.
Regarding claim 1, Bohm teaches an electronic device (Bohm: Fig. 1, continuous analyte sensor system 8) secured to a user (Fig. 1, device is secured to the user; para. 0119-0120), comprising: a medicament delivery unit (device can include an insulin delivery device; para. 0119) for delivering medicament to the user (para. 0119); a biological sensor (Fig. 1, comprising sensor electronics module 12 and analyte sensor 10) for sensing biological data of the user (Fig. 2A, compression, temperature, and blood analyte; para. 0117 and 0125) and generating biological sensor data (para. 0117 and 0125) indicative of the sensed biological data (para. 0117 and 0125); a compression sensor (Fig. 2A, compression sensor 254) for sensing compression of the biological sensor (12 and 10) and/or biological tissue of the user (sensor 254 indicates compression of tissue and force to the sensor module 12; para. 0279) and generating compression sensor data (para. 0279); and a processor (Fig. 2A, processor module 214) configured for receiving the compression sensor data (Fig. 2A, module 214 receives and processes all data; para. 0127) from the compression sensor (254) and taking corrective action (module 12 can modify or apply a different algorithm to measure data and/or modify medication administration based on the level of detected force during excess compression; para. 0276 and 0279) when the compression sensor data (para. 0279) from the compression sensor (254) indicates excessive compression of the biological sensor (12 and 10) and/or biological tissue of the user (para. 0276 and 0279), wherein the corrective action (para. 0276 and 0279) comprises adjusting the biological sensor data (para. 0117 and 0125) generated by the biological sensor (12 and 10) to compensate for error (para. 0276) introduced by the excessive compression (module 12 can modify or apply a different algorithm to measure data and/or modify medication administration based on the level of detected force to compensate for excess compression; para. 0276 and 0279), the adjusting (para. 0276 and 0279) comprising generating an adjusted biological sensor value (modified algorithm produces data; para. 0279) using a model (different algorithm; para. 0279) that accounts for the excessive compression (para. 0276) indicated by the compression sensor data (para. 0279).
Regarding claim 2, Bohm teaches the device above, wherein the corrective action (para. 0276 and 0279) includes triggering an alarm that indicates to the user (module 12 can initiate an alarm; para. 0279) that there is the excessive compression of the biological sensor (12 and 10) and/or biological tissue of the user (para. 0276 and 0279).
Regarding claim 3, Bohm teaches the device above, wherein the alarm (module 12 can initiate an alarm; para. 0279) is part of the electronic device (8) and the alarm (para. 0279) includes at least one of a vibratory alarm or an audio alarm (module 12 can initiate an alarm that is audible or tactile; para. 0279).
Regarding claim 4, Bohm teaches the device above, wherein the corrective action (para. 0276 and 0279) includes one of modifying an amount of medicament delivered to the user by the medicament delivery unit (para. 0119) to compensate for the excessive compression or adjusting the biological sensor data from the biological sensor (12 and 10) to compensate for the excessive compression (module 12 can modify or apply a different algorithm to measure data and/or modify medication administration based on the level of detected force during excess compression; para. 0276 and 0279).
Regarding claim 7, Bohm teaches the device above, further comprising an adhesive layer (Fig. 2B, adhesive pad 250) having an adhesive (para. 0146) for securing the electronic device (8) to the user (para. 0146).
Regarding claim 13, Bohm teaches a method performed by a processor (214) of an electronic device (8), comprising: receiving sensor data (para. 0279) from a compression sensor (254) of a glucose monitor (Fig. 1, comprising sensor electronics module 12 and analyte sensor 10, which monitors user glucose; para. 0117) for a user; processing the sensor data (para. 0279) from the compression sensor (254) with the processor (214) to determine that the glucose monitor (12 and 10) and/or biological tissue of the user is being compressed (para. 0279); and with the processor (214), triggering corrective action (para. 0279) responsive to the determining that the glucose monitor (12 and 10) and/or biological tissue of the user is being compressed (para. 0279), wherein the corrective action (para. 0276 and 0279) comprises adjusting the biological sensor data (para. 0117 and 0125) generated by the biological sensor (12 and 10) to compensate for error (para. 0276) introduced by the excessive compression (module 12 can modify or apply a different algorithm to measure data and/or modify medication administration based on the level of detected force to compensate for excess compression; para. 0276 and 0279), the adjusting (para. 0276 and 0279) comprising generating an adjusted biological sensor value (modified algorithm produces data; para. 0279) using a model (different algorithm; para. 0279) that accounts for the excessive compression (para. 0276) indicated by the compression sensor data (para. 0279).
Regarding claim 14, Bohm teaches the method above, wherein the compression sensor (254) is an electronic sensor (sensor 254 can be an electric pressure transducer; para. 0280) that senses pressure or magnitude of force (para. 0279).
Regarding claim 15, Bohm teaches the method above, wherein the compression sensor (254) is a mechanical sensor (sensor 254 can be an electric pressure transducer that senses mechanical external pressure upon the sensor system; para. 0280).
Regarding claim 16, Bohm teaches the method above, wherein the compression sensor (254) is secured to a bottom surface of the glucose monitor that faces the user (Fig. 2C, sensor 254 can be in a mounting unit that holds sensor 10 with a compressible portion of the housing. Sensor 10 faces the user; para. 0285).
Regarding claim 17, Bohm teaches the method above, wherein the corrective action (para. 0279) includes initiating one or more alarms (para. 0279) to alert the user of the glucose monitor (12 and 10) and/or the biological tissue of the user is being compressed (para. 0279).
Regarding claim 18, Bohm teaches the method above, wherein the corrective action (para. 0279) comprises adjusting glucose readings from the glucose monitor (12 and 10) to compensate for the compression (modify or apply different algorithm for measuring data; para. 0279).
Regarding claim 19, Bohm teaches the method above, wherein the corrective action (para. 0279) is sending data (para. 0279) to an insulin delivery device (para. 0119) indicative of the excessive compression (para. 0279) of the glucose monitor (12 and 10) and/or the biological tissue of the user (para. 0279).
Regarding claim 21, Bohm teaches the device above, wherein the model (algorithm; para. 0279) accounts for a magnitude of the excessive compression (the applied algorithm is based on the level of detected force; para. 0279).
Regarding claim 22, Bohm teaches the device above, wherein the adjusted biological sensor value (para. 0279) is determined based on a weighted combination of a raw sensor value (measured data; para. 0279) and a predicted value (estimative algorithm; para. 0088, 0104, and 0232), each of which is weighted based on a magnitude of the compression (para. 0279).
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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Fujii et al. (US Patent Publication No. 20210244379 A1), hereinafter Fujii.
Regarding claim 5, Bohm teaches the device above, further comprising one or more housings (Fig. 2B, mounting unit 240) for encasing the medicament delivery unit and the biological sensor (Fig. 2B, mounting unit houses the system 8; para. 0286), wherein the one or more housings (240) is a single housing (Fig. 2B, unit 240 is singular).
Bohm does not expressly disclose a compliant layer to which the compression sensor is secured or positioned against, wherein the compliant layer is secured to the housing.
Fujii teaches a compliant layer (Fujii: Fig. 3B, protective layer 27) to which a sensor (Fig. 1, piezoelectric film 20) is secured or positioned against (Fig. 3B, film 20 is secured to material 52 layer 27), wherein the compliant layer (27) is secured to a housing (Fig. 1, layer 27 is secured to film 20, which is secured to the base 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device to comprise a compliant layer to which the compression sensor is secured or positioned against, wherein the compliant layer is secured to the housing as taught by Fujii in order to provide mechanical strength and heat resistance to the sensor (Fujii: para. 0067).
Regarding claim 6, Bohm in view of Fujii discloses the device above.
Bohm does not expressly disclose further comprising an additional compliant layer positioned so that the compression sensor is situated between the compliant layer and the additional compliant layer.
Fujii teaches an additional compliant layer (Fujii: Fig. 3B, protective layer 28) positioned so that the sensor (20) is situated between the compliant layer (27) and the additional compliant layer (Fig. 3B, film 20 is situated between protective layers 27 and 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Bohm to comprise an additional compliant layer positioned so that the compression sensor is situated between the compliant layer and the additional compliant layer as taught by Fujii in order to provide mechanical strength and heat resistance to the sensor (Fujii: para. 0067).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Lintereur et al. (US Patent Publication No. 20200101223 A1), hereinafter Lintereur.
Regarding claim 20, Bohm teaches the method above, wherein the electronic device (8) is an insulin delivery device (para. 0119).
Bohm does not expressly disclose that the insulin delivery device is attached to the user.
Lintereur teaches an insulin delivery device (Lintereur: infusion device 102 injects insulin; para. 0035), wherein the device (102) is attached to the user (device 102 is secured to user; para. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Bohm such that the insulin delivery device is attached to the user as taught by Lintereur in order to simultaneously receive analyte or other sensor data while also delivering infusion (Lintereur: para. 0037-0039).
Response to Arguments
Applicant’s arguments, see page 9, filed 30 April 2026, with respect to objections to the drawings and specifications have been fully considered and are persuasive. The objections of the drawings and specifications has been withdrawn.
Applicant’s arguments, see page 10, filed 30 April 2026, with respect to the rejection of claim 19 under 35 USC 112(b) have been fully considered and are persuasive. The rejection of claim 19 has been withdrawn.
Applicant’s arguments, see page 10, filed 30 April 2026, with respect to the rejections of claims 1-7 and 13-20 under 35 USC 102(a)(2) and 35 USC 103 have been fully considered but are not persuasive.
Applicant argues that the amended claim language of claim 1 and 13 is not disclosed in Bohm, wherein Bohm does not expressly disclose applying a model that accounts for excessive compression. Specifically, applicant argues that the device of Bohm applies the correction in algorithm after the data is corrected, rather than adjusting the sensor data directly.
The broadest reasonable interpretation of “model” implies a mathematical system of data and inferences of an entity or phenomena. Bohm discloses applying an algorithm, which is a computational process that which, in the case of Bohm, extrapolates measured data (Bohm: para. 0088). Furthermore, when the applicant states “this suggests that the correction is applied in algorithm that processes the data after it is corrected”, applicant is applying speculate as to what Bohm suggests rather than what Bohm directly states. Bohm clearly discloses applying an algorithm to the measured data, not after a correction, as the applicant describes. Therefore the rejection is maintained.
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.
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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