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 .
Claims 19-38 are examined in this office action.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 19-23, 30, 31, and 33-38 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Katuin et al. (US Pub No. 20210290841 A1).
Regarding claim 19, Katuin discloses an electronic system (electronics assembly 276, Fig. 6) for drug delivery device (medication delivery device 10, Fig. 1) comprising:
a dose setting (dose setting member 30, Fig. 2) and drive mechanism (drive member 28, Fig. 2) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device ("A dose setting member 30 is coupled to housing 12 for setting a dose amount to be dispensed by device 10." - Para [0039]) and a dose delivery operation for delivering a set dose ("The dose dispensing mode of operation …" - Para [0048]), the electronic system comprising:
a sensor arrangement (sensor system 284, Fig. 5) for generating measurement data related to a size of the dose set by the dose setting operation and/or delivered by the dose delivery operation ("Dose detection system 284 may sense rotation of the dose setting member … the sensed rotation of the dose setting member … may be used to determine the amount of medication delivered from medication delivery device." - Para [0055]);
a microcontroller system (microcontroller unit (MCU) 502, Fig. 13) connected to the sensor arrangement ("MCU 502 communicates with the rotation sensor 286 …" - Para [0071]), the microcontroller system comprising at least one microcontroller (microcontroller unit (MCU) 502, Fig. 13); and
a memory (memory 506, Fig. 13);
wherein the microcontroller system is configured to operate the sensor arrangement during the dose setting operation and/or during the dose delivery operation to obtain measurement data (MCU 502 is operative to … determine the amount of medication delivered from medication delivery device 210 based on the information received from rotational sensor 286." - Para [0071]), and store a dose record in the memory ("MCU 502 may store the detected amount of units … in a generated dose record in memory 506." - Para [0071]); and
wherein the microcontroller system is configured to set at least one flag and/or a specific purpose value in the dose record under pre-defined circumstances ("The generated dose record may include … error log messages, etc." - Para [0071]).
Regarding claim 20, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the dose setting (dose setting member 30, Fig. 2) and drive mechanism (drive member 28, Fig. 2) comprises a first member (dose setting member 30, Fig. 4), and an extent of a specific relative movement between the first member and a second member (actuator 50, Fig. 2) during the dose delivery operation and/or a preceding dose setting operation corresponds to the size of the dose delivered by the dose delivery operation ("During the dose dispensing operation, the amount of medicine expelled from the medication delivery device 10 is proportional to the amount of rotational movement of the dose setting member 30 relative to actuator 50 …" - Para [0051]); and
wherein the measurement data is indicative of the extent of the specific relative movement between the first member and the second member ("The detection sensor system 284 includes the rotational sensor 286 operatively communicating with the controller of the circuit board 325 for receiving signals from the sensors representative of the sensed rotation." - Para [0060]).
Regarding claim 21, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the microcontroller system (MCU 502, Fig. 13) is configured to set the dose record ("dose record in memory 506." - Para [0071]) such that the dose record indicates the size of the dose (MCU 502 may store the detected amount of units … in a generated dose record in memory 506." - Para [0071]) and a time stamp of the dose at least in normal operation ("The generated dose record may include time/date stamp, dose delivered amount …" - Para [0071]).
Regarding claim 22, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the microcontroller system (MCU 502, Fig. 13) comprises an electronic clock for providing date and time information ("… a time delay module 518 may be in communication with the event log module 516 and a timer, shown as a time clock RTC." - Para [0078]); and wherein the microcontroller system (MCU 502, Fig. 13) is configured to read the electronic clock for determining the time stamp of the dose ("… the controller can wake up, receive the signals from the event log module, and store data of dosing information into memory." - Para [0078], "The generated dose record may include time/date stamp …" - Para [0071]).
Regarding claim 23, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the microcontroller system (MCU 502, Fig. 13) is configured to determine the size of the dose set by the dose setting operation and/or delivered by the dose delivery operation ("MCU 502 is operative to perform the operations described herein, including determining the number of units indicative of total angular movement of the dose setting member used to determine the amount of medication delivered from medication delivery device 210 based on the information received from rotational sensor 286. " - Para [0071]).
Regarding claim 30, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
a dose record pattern ("MCU 502 may store the detected amount of units … in a generated dose record in memory 506." - Para [0071]) comprises or consists of a time stamp field, which is at least suitable for storing the time stamp of the dose, and a dose size field, which is at least suitable for storing the size of the dose ("The generated dose record may include time/date stamp, dose delivered amount …" - Para [0071]).
Regarding claim 31, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the dose record pattern ("MCU 502 may store the detected amount of units … in a generated dose record in memory 506." - Para [0071]) comprises one or more of a power source status flag field, a speed flag field, a button timeout flag field, a checksum field, a first use time field, a number of dose records field, a sync mode field, a voltage field, a temperature field, an error flag field ("The generated dose record may include … error log messages …" - Para [0071]), a dose duration flag field, a switch state flag field, and a device age flag field.
Regarding claim 33, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the dose size field can be set, for each valid dose size, to a corresponding individual dose size value, and the dose size field can be set to specific purpose values different from the corresponding individual dose size values ("MCU 502 may store the detected amount of units or angular movement and/or medication separately or together in a generated dose record in memory 506." - Para [0071]) depending on corresponding pre-defined circumstances (MCU is operative to … determine the amount of medication delivered from medication delivery device 210 based on the information received from rotational sensors 286." - Para [0071]).
Regarding claim 34, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the microcontroller system is configured to, in the case where it sets the dose size field to any one of at least a subset of the specific purpose values ("The generated dose record may include … dose delivered amount …" - Para [0071]), store, for the same dose delivery operation, an additional dose record in which the dose size field is set to a corresponding value for the size of the dose ("MCU 502 may store the detected amount of units or angular movement and/or medication separately or together in a generated dose record in memory 506." - Para [0071]).
Regarding claim 35, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the microcontroller system is configured to set the time stamp field to the time stamp in normal operation ("The generated dose record may include time/date stamp, dose delivered amount …" - Para [0071]).
Regarding claim 36, Katuin discloses the electronic system (electronics assembly 276, Fig. 6) as recited above, wherein
the microcontroller system is configured to set the time stamp field to any one of several different specific purpose values for the time stamp field ("The generated dose record may include time/date stamp, dose delivered amount …" - Para [0071]) depending on corresponding pre-defined circumstances, wherein it depends on the corresponding pre-defined circumstances ("The time delay module 518 is operable to determine the amount of time elapsed T …" - Para [0078]) which one of a plurality of specific purpose values for the time stamp field are to be set in the time stamp field ("Once dosing is complete based on the time delay block, the controller can … store data of dosing information into memory." - Para [0078]).
Regarding claim 37, Katuin discloses a drug delivery device (medication delivery device 10, Fig. 1) for delivery of a medicament, the drug delivery device comprising:
a dose setting (dose setting member 30, Fig. 2) and drive mechanism (drive member 28, Fig. 2) configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device ("A dose setting member 30 is coupled to housing 12 for setting a dose amount to be dispensed by device 10." - Para [0039]) and a dose delivery operation for delivering a set dose ("The dose dispensing mode of operation …" - Para [0048]);
an electronic system (electronics assembly 276, Fig. 6) comprising:
a sensor arrangement (sensor system 284, Fig. 5) for generating measurement data related to a size of the dose set by the dose setting operation and/or delivered by the dose delivery operation ("Dose detection system 284 may sense rotation of the dose setting member … the sensed rotation of the dose setting member … may be used to determine the amount of medication delivered from medication delivery device." - Para [0055]);
a microcontroller system (microcontroller unit (MCU) 502, Fig. 13) connected to the sensor arrangement ("MCU 502 communicates with the rotation sensor 286 …" - Para [0071]), the microcontroller system comprising at least one microcontroller (microcontroller unit (MCU) 502, Fig. 13); and
a memory (memory 506, Fig. 13);
wherein the microcontroller system is configured to operate the sensor arrangement during the dose setting operation and/or during the dose delivery operation to obtain measurement data (MCU 502 is operative to … determine the amount of medication delivered from medication delivery device 210 based on the information received from rotational sensor 286." - Para [0071]), and store a dose record in the memory ("MCU 502 may store the detected amount of units … in a generated dose record in memory 506." - Para [0071]); and
wherein the microcontroller system is configured to set at least one flag and/or a specific purpose value in the dose record under pre-defined circumstances ("The generated dose record may include … error log messages, etc." - Para [0071]).
Regarding claim 38, Katuin discloses a method for operating an electronic system for a drug delivery device ("A method of determining an amount of dose dispensing with any one of the delivery devices described herein.' - Para [0089]), the drug delivery device (medication delivery device 10, Fig. 1) comprising:
a dose setting (dose setting member 30, Fig. 2) and drive mechanism (drive member 28, Fig. 2) that is configured to perform a dose setting operation for setting a dose to be delivered by the drug delivery device ("A dose setting member 30 is coupled to housing 12 for setting a dose amount to be dispensed by device 10." - Para [0039]) and a dose delivery operation for delivering a set dose ("A dose setting member 30 is coupled to housing 12 for setting a dose amount to be dispensed by device 10." - Para [0039]), wherein the electronic system (electronics assembly 276, Fig. 6) comprises a sensor arrangement (sensor system 284, Fig. 5) for generating measurement data related to a size of the dose set by the dose setting operation and/or delivered by the dose delivery operation ("Dose detection system 284 may sense rotation of the dose setting member … the sensed rotation of the dose setting member … may be used to determine the amount of medication delivered from medication delivery device." - Para [0055]), a memory (memory 506, Fig. 13), and a microcontroller system (microcontroller unit (MCU) 502, Fig. 13) connected to the sensor arrangement ("MCU 502 communicates with the rotation sensor 286 …" - Para [0071]), the microcontroller system comprising at least one microcontroller (microcontroller unit (MCU) 502, Fig. 13), the method comprising:
operating, by the microcontroller system, the sensor arrangement during the dose setting operation and/or during the dose delivery operation to obtain the measurement data ("Dose detection system 284 may sense rotation of the dose setting member … the sensed rotation of the dose setting member … may be used to determine the amount of medication delivered from medication delivery device." - Para [0055]);
storing a dose record in the memory ("MCU 502 may store the detected amount of units … in a generated dose record in memory 506." - Para [0071]); and
setting at least one flag and/or a specific purpose value in the dose record under pre- defined circumstances ("The generated dose record may include … error log messages, etc." - Para [0071]).
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) 25, 27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katuin et al. (US Pub No. 20210290841 A1) in view of Adams et al. (WO 2020072299 A1).
Regarding claim 25, Katuin in view of Adams discloses the electronic system (Katuin, electronics assembly 276, Fig. 6) as recited above, wherein
Katuin does not expressly disclose that the microcontroller system is configured to determine if a dispense speed during the dose delivery operation exceeds a dispense speed threshold and to set the dose record, in the case that the dispense speed during the dose delivery operation exceeds the dispense speed threshold, such that the dose record indicates that the dispense speed during the dose delivery operation exceeded the dispense speed threshold.
Adams teaches that the microcontroller system (processing circuit 2008) ("… processing circuit may also be implemented using other types of components, such as a microcontroller (MCU) …" - Para [0087]) is configured to determine if a dispense speed during the dose delivery operation exceeds a dispense speed threshold and to set the dose record, in the case that the dispense speed during the dose delivery operation exceeds the dispense speed threshold ("… the pushing force imparted by drive mechanism 24 as it drives syringe assembly 22 from the storage position in the proximal direction may cause accelerometer 2012 to detect an acceleration in the distal direction … this distal acceleration may cause accelerometer 2012 to output a first acceleration spike that may be detected by processing circuit 2008." - Para [00135]) ("If the frequency content of the accelerometer output signal [is] above a certain frequency threshold, or within a certain frequency range, exceeds a pre-set threshold, processing circuit 2008 may determine that an acceleration spike has been detected." - Para [00199]), such that the dose record indicates that the dispense speed during the dose delivery operation exceeded the dispense speed threshold ("… processing circuit 2008 may record initiation and/or completion of the dispensing event in memory, and also communicate completion of the dispensing event to a user." - Para [00182]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic system of Katuin to include that the microcontroller system is configured to determine if a dispense speed during the dose delivery operation exceeds a dispense speed threshold and to set the dose record, in the case that the dispense speed during the dose delivery operation exceeds the dispense speed threshold, such that the dose record indicates that the dispense speed during the dose delivery operation exceeded the dispense speed threshold as taught by Adams in order to communicate the initiation and/or completion of the dispensing event in memory (Adams, Para [00166]).
Examiner interprets the detected acceleration as the dispense speed. When the acceleration does exceed the threshold it is called an acceleration spike, which is indicative of either the initiation or completion of a dispensing event, which is what is recorded.
Regarding claim 27, Katuin in view of Adams discloses the electronic system (Katuin, electronics assembly 276, Fig. 6) as recited above, comprising:
Katuin does not expressly disclose a temperature sensor; wherein the microcontroller system is configured to determine if a temperature is below a pre-determined minimum temperature and to set the dose record such that the dose record indicates that the temperature was below the pre-determined minimum temperature and/or outside a pre-determined temperature range, and/or to determine if the temperature is above a pre-determined maximum temperature and to set the dose record such that the dose record indicates that the temperature was above the pre-determined maximum temperature and/or outside the pre-determined temperature range.
Adams teaches a temperature sensor (temperature sensor 120, Para [0087]); wherein the microcontroller system (processing circuit 2008) is configured to determine if a temperature is below a pre-determined minimum temperature and to set the dose record such that the dose record indicates that the temperature was below the pre-determined minimum temperature and/or outside a pre-determined temperature range("At step 1410, process 1400 determines whether the medication has warmed to the target injection temperature. If not, process 1400 branches to step 146, at which process 1400 informs the user that the medication is still warming …" - Para [00112]), and/or to determine if the temperature is above a pre-determined maximum temperature and to set the dose record such that the dose record indicates that the temperature was above the pre-determined maximum temperature and/or outside the pre-determined temperature range("At step 1410, process 1400 determines whether the medication has warmed to the target injection temperature. If not, process 1400 branches to step 146, at which process 1400 informs the user that the medication is still warming …" - Para [00112]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic system of Katuin to include a temperature sensor; wherein the microcontroller system is configured to determine if a temperature is below a pre-determined minimum temperature and to set the dose record such that the dose record indicates that the temperature was below the pre-determined minimum temperature and/or outside a pre-determined temperature range, and/or to determine if the temperature is above a pre-determined maximum temperature and to set the dose record such that the dose record indicates that the temperature was above the pre-determined maximum temperature and/or outside the pre-determined temperature range as taught by Adams in order to determine if the measured temperature satisfies certain pre-defined and pre-stored ideal injection temperature parameters (Adams, Para [00163]).
Regarding claim 29, Katuin in view of Adams discloses the electronic system (Katuin, electronics assembly 276, Fig. 6) as recited above, comprising:
Katuin does not expressly disclose that an electric power source; wherein the microcontroller system is configured to detect if a voltage provided by the electric power source is below a pre-determined voltage threshold, if a remaining charge in the electric power source is below a pre-determined charge threshold, and/or if a remaining electrical energy stored in the electric power source is below a pre-determined energy threshold, and to set the dose record such that the dose record indicates that a status of the electric power source is critical if at least any one of these three above conditions applies.
Adams teaches that an electric power source (power source 2002, Fig. 21A); wherein the microcontroller system (processing circuit 2008) is configured to detect if a voltage provided by the electric power source is below a pre-determined voltage threshold, if a remaining charge in the electric power source is below a pre-determined charge threshold ("If the remaining battery power level is less than or equal to the low battery threshold …" - Para [00171]), and/or if a remaining electrical energy stored in the electric power source is below a pre-determined energy threshold, and to set the dose record such that the dose record indicates that a status of the electric power source is critical if at least any one of these three above conditions applies ("If the remaining battery power level is less than or equal to the low battery threshold ... processing circuit 2008 branches to step 2830. At step 2830, processing circuit 2008 writes its "last state" to NFC circuit 2004." - Para [00171-Para 00172]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic system of Katuin to include that an electric power source; wherein the microcontroller system is configured to detect if a voltage provided by the electric power source is below a pre-determined voltage threshold, if a remaining charge in the electric power source is below a pre-determined charge threshold, and/or if a remaining electrical energy stored in the electric power source is below a pre-determined energy threshold, and to set the dose record such that the dose record indicates that a status of the electric power source is critical if at least any one of these three above conditions applies as taught by Adams in order to determine if it will soon lack the power to continue (Adams, Para [00171]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katuin et al. (US Pub No. 20210290841 A1) in view of Adams et al. (WO 2020072299 A1) and in further view of Horan et al. (US Pub No. 20240181263 A1).
Regarding claim 26, Katuin in view of Adams and Horan discloses the electronic system (Katuin, electronics assembly 276, Fig. 6) as recited above, wherein
Katuin does not expressly disclose that the microcontroller system is configured to determine if a dispense speed during the dose delivery operation exceeds a dispense speed threshold and to set the dose record, in the case that the dispense speed during the dose delivery operation does not exceed the dispense speed threshold, such that the dose record indicates that the dispense speed during the dose delivery operation did not exceed the dispense speed threshold.
Adams teaches that the microcontroller system (processing circuit 2008) is configured to determine if a dispense speed during the dose delivery operation exceeds a dispense speed threshold ("… the pushing force imparted by drive mechanism 24 as it drives syringe assembly 22 from the storage position in the proximal direction may cause accelerometer 2012 to detect an acceleration in the distal direction … this distal acceleration may cause accelerometer 2012 to output a first acceleration spike that may be detected by processing circuit 2008." - Para [00135]) ("If the frequency content of the accelerometer output signal [is] above a certain frequency threshold, or within a certain frequency range, exceeds a pre-set threshold, processing circuit 2008 may determine that an acceleration spike has been detected." - Para [00199]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention to modify the electronic system of Katuin to include that the microcontroller system is configured to determine if a dispense speed during the dose delivery operation exceeds a dispense speed threshold as taught by Adams in order to communicate the initiation and/or completion of the dispensing event in memory (Adams, Para [00166]).
Examiner interprets the frequency content of the accelerometer output signal being within a certain frequency range as inclusive of the frequency not exceeding the pre-set threshold.
Katuin in view of Adams does not expressly disclose that the microcontroller is configured to set the dose record, in the case that the dispense speed during the dose delivery operation does not exceed the dispense speed threshold, such that the dose record indicates that the dispense speed during the dose delivery operation did not exceed the dispense speed threshold.
Horan teaches that the microcontroller is configured to set the dose record, in the case that the dispense speed during the dose delivery operation does not exceed the dispense speed threshold, such that the dose record indicates that the dispense speed during the dose delivery operation did not exceed the dispense speed threshold ("If the determined patient metric does not exceed the first threshold, the second medical device associated with the determined patient metric is not recommended (e.g., via an alert, a notification, etc.) at step 204." - Para [0061]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic system of Katuin in view of Adams to include that the microcontroller is configured to set the dose record, in the case that the dispense speed during the dose delivery operation does not exceed the dispense speed threshold, such that the dose record indicates that the dispense speed during the dose delivery operation did not exceed the dispense speed threshold as taught by Horan to provide one or more alerts or notifications (Horan, Para [0057]).
Claim(s) 28 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katuin et al. (US Pub No. 20210290841 A1) in view of Calderon et al. (EP 3739591 A1).
Regarding claim 28, Katuin in view of Calderon discloses the electronic system (Katuin, electronics assembly 276, Fig. 6) as recited above, wherein
Katuin does not expressly disclose that the microcontroller system is configured to count a number of dose delivery operations performed and to indicate in the dose record if the number of dose delivery operations performed is above a pre-determined operations threshold, and/or to determine a number of dose records stored in the memory and to indicate in the dose record if the number of dose records stored in the memory is above a pre-determined number threshold.
Calderon teaches that the microcontroller system (electronics module 120, Fig. 5) is configured to count a number of dose delivery operations performed ("The electronics module 120 may count doses …" - Para [0097]) and to indicate in the dose record if the number of dose delivery operations performed is above a pre-determined operations threshold, and/or to determine a number of dose records stored in the memory ("…a first electronic dose reading … may be compared to a second electronic dose reading … to determine whether there is a discrepancy and/or whether the discrepancy exceeds a threshold." - Para [0094]) and to indicate in the dose record if the number of dose records stored in the memory is above a pre-determined number threshold ("The electronics module 120 may record a dosing event each time the sensor system 128 provides a pressure measurement above the threshold. " - Para [0095]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic system of Katuin to include that the microcontroller system is configured to count a number of dose delivery operations performed and to indicate in the dose record if the number of dose delivery operations performed is above a pre-determined operations threshold, and/or to determine a number of dose records stored in the memory and to indicate in the dose record if the number of dose records stored in the memory is above a pre-determined number threshold as taught by Calderon for counting the number of doses delivered (Calderon, Para [0097]).
Regarding claim 32, Katuin in view of Calderon discloses the electronic system (Katuin, electronics assembly 276, Fig. 6) as recited above, wherein
the dose record pattern includes at least the time stamp field (Katuin, "The generated dose record may include time/date stamp …" - Para [0071]), the dose size field (Katuin, "The generated dose record may include … dose delivered amount …" - Para [0071]), and the power source status flag field (Katuin, "The generated dose record may include … battery charge status …" - Para [0071]).
Katuin does not expressly disclose that the dose record pattern includes at least the button timeout flag field, a fast dose flag field, and a very fast dose flag field; wherein the power source status flag field, the button timeout flag field, the fast dose flag field, and the very fast dose flag field are one-bit flag fields.
Calderon teaches that the dose record pattern includes at least the button timeout flag field ("… the electronics module 120 may be configured to operate in a … sleep state …" - Para [0007]), a fast dose flag field ("…the electronics module my generate a good inhalation event when the measurements from the sensor system 128 indicate a flow rate in a particular range (e.g., between 200 liters per min (L/min) and 45 L/min) …" - Para [0056]), and a very fast dose flag field ("… the electronics module 120 may generate … an excessive inhalation event when the measurements from the sensor system 128 indicate a flow rate that is greater than an upper threshold (e.g., greater than 200 L/min)." - Para [0056]); wherein the power source status flag field, the button timeout flag field, the fast dose flag field, and the very fast dose flag field are one-bit flag fields.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic system of Katuin to include that the dose record pattern includes at least the button timeout flag field, a fast dose flag field, and a very fast dose flag field; wherein the power source status flag field, the button timeout flag field, the fast dose flag field, and the very fast dose flag field are one-bit flag fields as taught by Calderon to compare one or more measurements from the sensor system to one or more threshold values (Calderon, Para [0056]).
Examiner interprets the sleep state, the good inhalation event, and the excessive inhalation event to be discreet or one-bit events.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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