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 .
Response to Restriction/Election
Applicant’s election without traverse of Group II, in the reply filed on November 24, 2025 is acknowledged. The Applicant elected Group II, which includes claims 20-35. Thus, claims 20-35 will now be examined on the merits.
Drawings
The drawings filed on 01/17/2023 are accepted.
Claim Rejections - 35 USC § 103
The following is a quotation of the appropriate paragraphs of AIA 35 U.S.C. 103(a) 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 20-28 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Wieder (EPO Patent EP 3 243 434 B1 – provided herewith.); in view of Reiner (U.S. Patent Publication 2019/0365325 A1).
Regarding claim 20, Wieder teaches a method for improving an accuracy of a measurement performed a biosensor (Wieder: Abstract, ¶10 [“Here a calibration measurement of the first phase is performed at the time of the analyte sensor being manufactured.”]), the method comprising:
receiving, from the biosensor, at least one unique identifier associated with manufacturing of the biosensor (Wieder: FIGS. 1-3; ¶¶68-72 [“The continuous glucose measurement system includes a patch device with a disposable unit 1 and an electronics 2, and a control device 3…pad 13 comprises an adhesive surface 130 that is designed to be attached to the patient’s skin, with the sensor 10 respectively the electrode carrier 101 projecting from the adhesive surface 130…”]; ¶79 [“The sensor identifier is provided in machine-readable form, exemplary as Data Matrix 121, on a housing of the inserter device 121. The sensor identifier is unique and may be provided, e. g., on an adhesive tag, ink-printed directly onto the housing of the inserter device, laser-engraved, or the like.”]); and
retrieving, using the unique identifier, one or more calibration adjustments associated with the biosensor, the one or more calibration adjustments accounting for differences in operation of the biosensor and other biosensors based on production data for the biosensor (Wieder: FIGS. 1-3; ¶¶92-94 [“…the remote database 4 determines, based on the received sensor identifier of the disposable unit 1, the matching initialization data set, i. e. the initialization data set that corresponds to the sensor identifier (step S3). A number initialization data sets is pre-stored by the remote database together with correspondence information between sensor identifiers and initialization data sets…matching initialization data are transmitted from the remote database 4 to the control device 3 (step S4) and, via the local control device communication unit 30 and the electronics communication unit 22, form the control device 3 to the electronics unit 2 (step S5)…The initialization data may directly be or include calibration information that is applied, during the application time of the disposable unit 1, for calibration purposes. The calibration data may include parameters such as sensitivities, slopes, offsets, linearization parameters etc. Alternatively or additionally, calibration information may be computed from the received initialization data.”]).
However, Wieder fails to explicitly teach receiving, from a microsensor of the biosensor, at least one unique identifier associated with manufacturing of the microsensor, and adjusting one or more operational parameters of the biosensor based on the one or more calibration adjustments.
Reiner, in an analogous art, discloses medical nanobots with embedded biosensors for real-time and continuous in-vivo anatomic localization, diagnosis, disease surveillance, and therapeutic intervention (Reiner: Abstract). Therein, Reiner teaches a microsensor of the biosensor, at least one unique identifier associated with manufacturing of the microsensor (Reiner: FIGS. 1A-2F; ¶92 [“…by integrating the miniaturized sensors 102, 105 etc., within the structure of the bot, each individual bot would possess functionality commensurate with both the individual and collective attributes of the embedded sensors. In circumstances in which different types of biosensors 104 etc., are contained within the same bot, the biosensor derived data may be complementary or synergistic to one another and lead the program to perform enhanced diagnosis.”]; ¶108 [“…bots are often multifunctional in nature and may possess a variety of different embedded nanotechnologies (e.g., micro-sensors), each individual property, functionality, or contained technology can be used to define an associated communication signal. As a result, an individual bot may have ten different associated signal frequencies it can respond to, in accordance with the individual property which is being sought. As an example, a bot containing three different types of embedded micro-sensors and possessing the combined functions of tissue/cell collection, bioassay, and chemical storage may have seven different radiofrequency communication signals (its individual unique identifier, one for each type of sensor (3)…”]), and adjusting one or more operational parameters of the biosensor based on the one or more calibration adjustments (Reiner: FIGS. 1A-2F; ¶182 [“This analysis would be subjected by the program to internal quality control (QC) and quality assurance (QA) tests (discussed later), which are aimed at ensuring that the acquired data has been validated for accuracy and the miniaturized biosensor technologies used in the analysis by the program have been appropriately calibrated and tested on a routine basis. Since the vast majority of derived data will be recorded by multiple individual biosensors, any variation in inter-sensor quantitative and/or qualitative measurements will serve as a trigger for additional testing, in order to identify and correct any individually deficient biosensor. When larger sample volumes are required for diagnosis and/or therapeutic actions, external transfer from the "acquisition" bot to an external storage bot or device 135 is often required. In addition to the intrinsic data associated with each individual biopsy/aspiration specimen, each specimen may require physical tagging in order to differentiate one specimen from another, since large numbers of individual specimens may be required to fulfill the requisite diagnostic and/or therapeutic requirements.”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the features of providing a microsensor of a biosensor, with at least one unique identifier associated with manufacturing of the microsensor, and adjusting one or more operational parameters of the biosensor based on the one or more calibration adjustments, disclosed by Reiner, into Wieder, with the motivation and expected benefit of dynamically adjusting operational parameters of the biosensor to account such changes as magnitude, frequency, and/or waveform of an biasing voltage and/or current, adjustments to an application force necessary to apply to the biosensor to a user’s skin, predicted sensor drift, and/or various other suitable adjustments that impact measurements obtained from the biosensor. This method for improving Wieder was within the ordinary ability of one of ordinary skill in the art based on the teachings of Reiner. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner to obtain the invention as specified in claim 20.
Regarding claim 21, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses the biosensor is configured to receive and use the one or more adjusted operational parameters to detect one or more analytes (Wieder: FIGS. 1-2; ¶90 [“Fig. 2 shows major steps of a procedure or method for initializing an analyte measurement system, e. g. an analyte measurement system as shown in Fig. 1…”]).
Regarding claim 22, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses sending, from the biosensor, the at least one unique identifier in response to initialization of the biosensor (Wieder: FIGS. 1-2; ¶91 [“…the sensor identifier is, via the remote control device communication unit 33, transmitted to the remote database 4 (step S2).”]). Reiner teaches sending at least one unique identifier in response to initialization of the microsensor between the microsensor and biosensor (Reiner: FIGS. 1A-2F; ¶¶48-52 [“…successful receipt of the unique signal, the authorized third party can in turn transmit a unique signal back via transmitter/receiver 129 to the bot 100 which would confirm successful anatomic localization using the location module 120, and approval of instituting the defined bot action…in the case of migratory bots, data is continuously being recorded in a database 115 of the computer system 113, commensurate with bot and embedded biosensor functionality. In addition to biosensor-derived data, anatomic localization of the migrating bot 100 is important in order to accurately determine the location of abnormal data.”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the features of sending at least one unique identifier in response to initialization of the microsensor between the biosensor and microsensor, disclosed by Wieder and Reiner, into Wieder, as modified by Reiner, with the motivation and expected benefit of linking a specific biosensor and a specific microsensor. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Wieder and Reiner. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner to obtain the invention as specified in claim 22.
Regarding claim 23, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Reiner additionally discloses the operational parameters include at least one of a magnitude of an input voltage supplied to the microsensor (Reiner: FIGS. 1A-2F; ¶¶45-46 [“…the positional relationships between the bot 100 and fixed anatomic marker 133 can be established in a variety of ways. In one application, as noted above, the bot 100 can emit a signal (e.g., ultrasound, photo-magnetic pulse, light, thermal) which will be received by sensors embedded in the fixed anatomic markers. Based upon the signal magnitude, time (between signal transmission and receipt), and direction, an anatomic vector will be created by the location module 120 which determines the specific location and distance between the two entities.”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the feature of observing an operational parameter such as a magnitude of an input voltage supplied to the microsensor, disclosed by Reiner, into Wieder, as modified by Reiner, with the motivation and expected benefit of includes predicting one or more performance metric(s) of the component. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Wieder and Reiner. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner to obtain the invention as specified in claim 23.
Regarding claim 24, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses the one or more calibration adjustments are retrieved from a network database (Wieder: FIGS. 1-2; ¶¶89-91 [“…the sensor identifier is, via the remote control device communication unit 33, transmitted to the remote database 4 (step S2). The remote database 4 is implemented on corresponding computing infrastructure, e. g. on a corresponding server, but may also be a decentralized cloud-based database.”]).
Regarding claim 25, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Reiner additionally discloses the one or more calibration adjustments are retrieved from a memory device on the microsensor (Reiner: FIGS. 1A-2F; ¶28 [“…the bots 100 accomplish their tasks by having their own internal electronics, such as an internal microprocessor 111 and memory 112, which runs a program to handle various bot 100 operations.”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the feature of retrieving one or more calibration adjustments from a memory device on the microsensor, disclosed by Reiner, into Wieder, as modified by Reiner, with the motivation and expected benefit of obtaining calibration adjustments without being in communication with a separate computing device or system. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Reiner. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner to obtain the invention as specified in claim 25.
Regarding claim 26, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses the calibration adjustments include one or more notifications related to the biosensor (Wieder: FIGS. 1-2; ¶87 [“…control device 3 typically further serves for entering calibration data that are transmitted to the patch device and may include supplementary functionality such as analyte concentration statistics, trend analysis, alerting in case of undesirable high or low analyte concentration values, e. g. glucose concentration values…”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the feature of providing calibration adjustments include one or more notifications related to the biosensor, disclosed by Wieder, into Wieder, as modified by Reiner, with the motivation and expected benefit of adjusting one or more operational parameters of the biosensor based on the one or more calibration adjustments. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Wieder. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner to obtain the invention as specified in claim 26.
Regarding claim 27, Wieder, in view of Reiner, teach all the limitations of the parent claim 26 as shown above. Wieder additionally discloses the one or more notifications includes a warning about possible malfunctions of the microsensor patch (Wieder: FIGS. 1-2; ¶¶106-108 [“…a unique identifier, e. g. a unique serial number of the disposable unit 1, is transmitted to the electronics unit 2 in step S5 respectively step S5’ and stored in the memory 21. In case of a complaint, e. g. a potential malfunctions of a disposable unit 1…”]).
Regarding claim 28, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses the one or more calibration adjustments further account for observed performance of other microsensor patches manufactured in conjunction with the microsensor patch associated with the unique identifier (Wieder: FIGS. 1-2; ¶¶106-108 {See above.}).
Regarding claim 31, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Reiner additionally discloses the unique identifier is received through wireless communication with the biosensor when the microsensor is installed into the biosensor (Reiner: FIGS. 1A-2F; ¶29 [“The computer system 113 interfaces with the bots 100 via a transmitter/receiver 124 (wireless, internal or external), which receives wireless signals from the transmitter 129 on the bots 100 within the system 128”] {See above.}).
Regarding claim 32, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses the unique identifier is received through wireless communication with the biosensor when the microsensor is installed into the biosensor (Wieder: FIGS. 1-2; ¶79 [“Alternatively or additionally, the Data Matrix 121 or another sensor identifier may be provided on a e. g. primary (sterile) package, a secondary package, an information leaflet, or the like, or a separate carrier, such as piece of paper or cardboard.”]).
Regarding claim 33, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Reiner additionally discloses the unique identifier is stored in a memory device in the microsensor (Reiner: FIGS. 1A-2F; ¶¶48-52 {See above.}, ¶28 [“…the bots 100 accomplish their tasks by having their own internal electronics, such as an internal microprocessor 111 and memory 112, which runs a program to handle various bot 100 operations.”] {See above.}).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the feature of storing at least one unique identifier in a memory device on the microsensor, disclosed by Reiner, into Wieder, as modified by Reiner, with the motivation and expected benefit of retrieving the unique identifier from the memory device of the microsensor. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Reiner. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner to obtain the invention as specified in claim 33.
Regarding claim 34, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Wieder additionally discloses receiving operational feedback, from a user, related to a performance of the biosensor (Wieder: FIGS. 1-2; ¶87 [“…control device circuitry 34 includes a user interface with input/output functionality, e. g. a touch screen, power supply, power management circuitry, and the like. Typically, the control device includes one or more microcomputers and/or microcontrollers which execute corresponding firmware and/or software code. The control device 3 serves for controlling operation of the analyte measurement system…”]).
Regarding claim 35, Wieder, in view of Reiner, teach all the limitations of the parent claim 34 as shown above. Wieder additionally discloses sending the operational feedback to a central database to update calibration adjustments related to one or more other microsensors associated to the biosensor via the unique identifier (Wieder: FIGS. 1-2; ¶¶89-91; [“…the sensor identifier is, via the remote control device communication unit 33, transmitted to the remote database 4 (step S2). The remote database 4 is implemented on corresponding computing infrastructure, e. g. on a corresponding server, but may also be a decentralized cloud-based database.”] {See above.}; ¶87 [“…control device circuitry 34 includes a user interface with input/output functionality, e. g. a touch screen, power supply, power management circuitry, and the like. Typically, the control device includes one or more microcomputers and/or microcontrollers which execute corresponding firmware and/or software code. The control device 3 serves for controlling operation of the analyte measurement system…”] {See above.}).
Claims 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Wieder, in view of Reiner; and further in view of Tremblay (WIPO | PCT Patent Publication WO 2021/203187 A1 – Provided with this action.).
Regarding claim 29, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. However, Wieder, in view of Reiner, fails to explicitly recite a microsensor patch manufactured on a wafer.
Tremblay, in an analogous art, discloses heat-loss pressure microsensors for measuring a gas pressure is disclosed that includes a plurality of pressure gauges arranged proximate to one another on a substrate. Therein, Tremblay discloses microsensors, such as a microsensor patch, which are manufactured on a wafer (Tremblay: FIG. 1; ¶¶44-45 [“The pressure gauge 100 of Fig. 1 may be used as one of the gauges in embodiments of heat-loss pressure microsensors disclosed herein…Fig. 1 can be fabricated using common integrated-circuit and MEMS/MOEMS wafer processing techniques, such as surface and bulk micromachining. In such techniques, the gauge components can be successively deposited and patterned on a substrate using thin-film deposition techniques paired with selective photoresist and sacrificial layer etching processes…”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the feature of manufacturing microsensors, such as a microsensor patch, on a wafer, disclosed by Tremblay, into Wieder, as modified by Reiner, with the motivation and expected benefit of utilizing well-known fabrication principles and techniques for manufacturing microsensors, such as a microsensor patch. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Tremblay. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner and Tremblay to obtain the invention as specified in claim 29.
Regarding claim 30, Wieder, in view of Reiner, teach all the limitations of the parent claim 20 as shown above. Tremblay discloses one or more calibration adjustments are related to measurements of one or more representative components a wafer on which the microsensor was manufactured on (Tremblay: FIG. 1; ¶41 [“The present techniques make it possible to collectively calibrate all or a subset of nominally identical two-gauge pressure microsensors fabricated on a same wafer by determining a calibration curve for only one of the pressure microsensors, despite the fact that pressure microsensors located far from one another on the wafer may suffer from different fabrication-related dimensional variations. This single calibration curve may then be used with acceptable accuracy with all of the pressure microsensors fabricated on the wafer or on a region thereof, even though the pressure microsensors may be used in different applications after the dicing of the wafer into individual dies. The use of such a single calibration curve may be advantageous in that it obviates the need to individually calibrate every pressure microsensor fabricated on a wafer…”]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the feature of relating one or more calibration adjustments to measurements representative of one or more components a wafer on which the microsensor was manufactured on, disclosed by Tremblay, into Wieder, as modified by Reiner, with the motivation and expected benefit of obviating the need for performing individual calibration runs may be costly, inefficient, or difficult to implement. This method for improving Wieder, as modified by Reiner, was within the ordinary ability of one of ordinary skill in the art based on the teachings of Tremblay. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Wieder and Reiner and Tremblay to obtain the invention as specified in claim 30.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Publication 2005/0137648 A1, to Cosendai et al., is directed to facilitating stimulating neural pathways of a patient’s body for the purpose of therapeutic medical treatment by rehabilitating weakened muscles and using neuroplasticity to retrain sequential muscle movements.
Canadian Patent Publication 3 156 085 A1, to Bhat et al., discloses an electrochemical-sensor structure having a substrate and a nanostructured-sensing surface that receives a volume of a sample fluid.
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/JEFFREY P AIELLO/Primary Examiner, Art Unit 2857