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 .
Claim Objections
Claim 32 is objected to because of the following informalities: Claim 32, the word “multilplications” is misspelled. Appropriate correction is required.
Specification
The incorporation by reference of the European patent application EP 21315167.3 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 09/22/2022 see MPEP 1893.03(b). Therefore, the specification amendment of 10/22/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p). The examiner recommends to delete the portion “the disclosures of which are incorporated herein by reference.”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 16-35 are rejected under 35 U.S.C. 103 as being unpatentable over Duke et al (US 10297350 B2) in view of Robertson et al (WO 2010075115 A2).
Regarding claim 16, Duke discloses an electronic device 10 provided for a drug delivery device 31,26 (col 5 lines 14-19; single device) or a drug delivery add-on device 16, wherein the drug delivery device or the drug delivery add-on device comprises a dose measurement function and a data transmission function (col.5, lines 20-50; fig 1; col.4, lines 48-57), and
wherein the electronic device comprises:
at least one first controller unit 32 configured for controlling dose related functions of the drug delivery device or drug delivery add-on device and for data processing functions comprising one or more first numerical calculations with dose related data (abstract; col 6, lines 50-55); and
at least one second controller unit (col 6, lines 50-55).
However, Duke fails to specifically disclose the at least one second controller unit is configured for data processing functions comprising one or more second numerical calculations with dose related data having a higher complexity than the one or more first numerical calculations and communication function, and wherein the at least one first controller unit is configured for using less power than the at least one second controller unit.
Robertson teaches an electronic device 100 including a power module 204 that controls power consumption ([055, 0058-059 ; fig 1B) with at least a first controller unit (low power microprocessor) and at least one second controller unit (high power microprocessor) configured for data processing functions comprising one or more second numerical calculations with dose related data having a higher complexity than the one or more first numerical calculations and communication functions [048-051,058,], wherein the at least one first controller unit is configured for using less power than the at least one second controller unit [048,049,0193,0200-0201,0214-0216]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke’s at least one first/second controller units by using Robertson’s teachings abovementioned since such modifications would have provided the at least two controller units with a low/high power characteristics and different processing to use less power.
Regarding claim 17, Duke discloses wherein the at least one first controller unit is configured to perform at least one of the following operations:
controlling a dose recording sensor system 16 provided for measuring doses selected and expelled with the drug delivery device; acquiring data from the dose recording sensor system; performing the one or more first numerical calculations with the acquired data (col. 4, lines 58-66; col 8, lines 8-43). Robertson discloses processors that can collect and process information via sensors [0256].
Regarding claim 18, Duke discloses wherein the at least one first controller unit comprises a single dose capture and recording controller unit 48 configured to control the dose recording sensor system provided for measuring doses selected and expelled with the drug delivery device, to acquire data from the dose recording sensor system, and to perform the one or more first numerical calculations with the acquired data (col 8, lines 8-43). Robertson discloses processors that can collect and process information via sensors [0256].
Regarding claim 19, Duke discloses wherein the at least one first controller unit has less program space than the at least one second controller unit (col. 5 lines 14-19; shows that the single device can be small and due to this can perform at least a
portion of the logic requiring less program space). Robertson discloses in [048] at least one first controller unit having low function and capacity.
Regarding claim 20, Duke discloses the invention substantially as claimed. However, it fails to disclose Howherein the at least one second controller unit is configured to perform at least one of the following operations: performing data communication with an external data processing device.
Robertson teaches the at least one second controller unit (high power microprocessor 1817) [0144,0172,0183]; fig 18, performing data communication with an external data processing device 1827. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke’s the at least one second controller unit by using Robertson’s teachings of transmitting/processing data to an external device as taught old and well known by Robertson.
Regarding claim 21, Duke discloses the invention substantially as claimed. Robertson teaches however in [0144,0172,0183] that performing data communication with the external data processing device comprises transmitting the acquired data. But Duke/Robertson does not disclose specifically transmitting the acquired data after the performed one or more first numerical calculations and/or the performed one or more second numerical calculations to the external data processing device. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke/Robertson with the specifics of transmitting the acquired data after the performed one or more first numerical calculations and/or the performed one or more second numerical calculations to the external data processing device, since it is well known in the art of processors that a numerical calculation is performed in order to transmit calculation to an external data processing.
Regarding claims 22-23, Duke discloses the invention substantially as claimed. However, Duke fails to disclose wherein the at least one second controller unit (high power) comprises a main controller unit configured to perform calculations having a higher complexity than the first numerical calculations, and a communication controller unit configured to perform communication tasks, and wherein the main controller unit is configured to perform the one or more second numerical calculations with the acquired data.
Robertson teaches, in [058-059] figs 1A-1B, the at least one second controller unit (high power) 208 comprises a main controller unit (fig 1B; 300) configured to perform calculations having a higher complexity than the first numerical calculations and second calculations, and a communication controller unit 302 configured to perform communication tasks [059]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke’s electronic device with Robertson’s teaching since such modification would have enhanced the communication tasks and performance of the device.
Regarding claim 24, Duke discloses the invention substantially as claimed. However, it fails to disclose wherein the data communication with the external data processing device comprises transmitting the acquired data after the performed one or more first numerical calculations and/or the performed one or more second numerical calculations to the external data processing device.
Robertson teaches however in [0144,0172,0183] that performing data communication with the external data processing device comprises transmitting the acquired data. But Duke/Robertson does not disclose specifically transmitting the acquired data after the performed one or more first numerical calculations and/or the performed one or more second numerical calculations to the external data processing device. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke/Robertson with the specifics of transmitting the acquired data after the performed one or more first numerical calculations and/or the performed one or more second numerical calculations to the external data processing device, since it is well known in the art of processors that a numerical calculation is performed in order to transmit calculation to an external data processing.
Regarding claim 25, Duke discloses wherein the electronic device is configured to activate one or more of the controller units only on demand, wherein activating a controller unit comprises switching the controller unit into a first operational state comprising a first functionality of the controller unit, and wherein deactivating a controller unit comprises switching the controller unit into a second operational state comprising a second functionality of the controller unit, which is reduced over the first functionality in order to reduce power consumption of the controller unit (col 7, lines 1-40; Col 6, lines 50-55). Robertson also discloses [058] activating and deactivating the controller unit to make it operational or idle for power management.
Regarding claim 26, Duke discloses the electronic device 10 of claim 25, comprising a controller activation unit in 26,31 being configured to process an input signal of the electronic device 10 and to activate one or more of the first controller unit or the second controller unit depending on the processing of the input signal (col 7, lines 1-40; Col 6, lines 50-55; col.6 lines 1-23). See also Summary of the invention. Robertson also discloses [058] activating and deactivating the controller unit to make it operational or idle for power management.
.
Regarding claim 27, Duke discloses wherein the controller activation unit 26,31 is configured to receive and process a signal indicating a dose selection (col. 9, line 56 - col. 10, line 15).
Regarding claim 28, Duke discloses wherein the controller activation unit is configured to activate one of the controller units for processing the input signal and for determining a desired function based on the input signal processing, and to activate one or more from the controller units depending on the determined desired function and to deactivate the other controller units (col 7, lines 1-40; Col 6, lines 50-55. Robertson also discloses [058] activating and deactivating the controller unit to make it operational or idle.
Regarding claim 29, Duke discloses wherein the controller activation unit is configured for: an activation of the at least one second controller unit after the at least one first controller unit was activated and all functions performed by the at least one first controller unit were completed, and a deactivation of the at least one first controller unit when the at least one second controller unit has obtained data from the at least one first controller unit (col 7, lines 1-40; Col 6, lines 50-55). Robertson also discloses [058] activating and deactivating the controller activation unit.
Regarding claim 30, Duke discloses the invention substantially as claimed. However, it fails to disclose wherein the at least one first controller unit and the at least one second controller unit are discrete units connected by a data bus.
Robertson teaches the at least one first controller unit and the at least one second controller unit are discrete units connected by a data bus [0173-0176, 0222]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke’s at least one first/second controller units by using Robertson’s teachings of discrete units connected to a data bus since it is taught old and well know by Robertson in order to control circuitry.
Regarding claim 31, Duke discloses wherein the at least one second controller unit (high power) comprises one or more of the following: a wireless interface (col. 4 line 28 – col. 5 line 19).
Regarding claim 32, Duke/Robertson discloses the invention substantially as claimed. However, Duke/Robertson fails to disclose wherein the one or more first and/or second numerical calculations comprise one or more higher order calculations on a battery voltage. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke/Robertson’s numerical calculations on a higher order one dose time and battery voltage since both references disclose the at least one second controller unit (high power) controls battery voltage due to its high-power controller as obvious. See also Robertson teaches in [0143] the environmental functional module may be configured to determine battery voltage; [0150-0151,0155,0177,0179].
Regarding claim 33, Duke discloses a drug delivery device or a drug delivery add-on device comprising:
an electronic device 10 comprising:
a battery (col. 6 lines 50-55) for supplying the electronic device with electrical energy,
at least one first controller unit (low power) 32 configured for controlling dose related functions of the drug delivery device or the drug delivery add-on device and for data processing functions with dose related data (col 4 line 58-col. 5 line 19); and
at least one second controller unit (high power) (col. 6 lines 50-55) configured for data processing functions comprising calculations with dose related data having a higher complexity calculations and communication functions.
Duke fails to disclose specifically the at least one first controller unit comprising numerical calculations with dose related data and the at least one second controller unit comprising one or more second numerical calculations with dose related data having a higher complexity than the one or more first numerical calculations and communication functions, and wherein the at least one first controller unit is configured for using less power than the at least one second controller unit.
Robertson teaches an electronic device 100 including a power module 204 that controls power consumption ([055, 0058-059 ; fig 1B) with at least a first controller unit (low power microprocessor) and at least one second controller unit (high power microprocessor) configured for data processing functions comprising one or more second numerical calculations with dose related data having a higher complexity than the one or more first numerical calculations and communication functions [048-051,058,], wherein the at least one first controller unit is configured for using less power than the at least one second controller unit [048,049,0193,0200-0201,0214-0216]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke’s at least one first/second controller units by using Robertson’s teachings abovementioned since such modifications would have provided the at least two controller units with a low/high power characteristics and different processing to use less power.
Regarding claim 34, Duke discloses wherein the at least one first controller unit has less program space than the at least one second controller unit (col.5 lines 14-19); shows that the single device can be small and due to this can perform at least a portion of the logic requiring less program space). Robertson discloses in [048] at least one first controller unit having low function and capacity.
Regarding claim 35, Duke/Robertson discloses the use of a battery. However, they fail to disclose wherein the battery is a button cell having a capacity in milliampere hours selected to supply an electrical current sufficient to operate the electronics device over a usual utilization time of the drug delivery device without requiring a battery replacement during the usual utilization time. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Duke/Robertson with the claimed battery button cell having a capacity in milliampere hours selected to supply an electrical current sufficient to operate the electronics device over a usual utilization time of the drug delivery device without requiring a battery replacement during the usual utilization time, since it is well known in the art to use this type of battery for wearable or implanted devices in order to allow the electronic device to work at it is intended.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights