The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
This is in response to the amendment filed on 6/23/26. Claims 8-9 and 20-23 have been cancelled. Therefore, Claims 1-7, 10-19 and 24 are pending in the application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Drawings
Objections to the Drawings have been withdrawn.
Claim Rejections - 35 USC § 103
Claims 1-7, 11-19 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (Casey; US 20220113201 A1), in view of Felber et al. (Felber; US 20210069425 A1).
Regarding Claim 1, Casey discloses an apparatus (Abstract, 100 of Fig 1 colorimetric based sensor system), comprising:
an NFC antenna (10 of Fig 1 antenna; [0054] the colorimetric based sensor system may employ an antenna and microchip combination to create a near field communication) configured to harvest energy and when powered by harvested energy to convey the harvested energy ([0033] antenna 10 harvests energy required for operation of the colorimetric based sensor system 100 from an interrogator (not shown) and retransmits data to the interrogator. The controller 30 routs the power harvested by the antenna 10 and/or control signals to the light emitter 40 and the light detector 50);
circuitry ([0032] microchip 20 is operatively connected to a controller 30) configured to be powered by the harvested energy and to be in data communication with the NFC antenna ([0033]);
an unpowered indicator (60, 61 of Fig 1 colorimetric based sensor, color patch) configured to exhibit an excursion indicator only when a temperature excursion of a substance has occurred ([0037]-[0039] colorimetric based sensor 60 also includes a sensor (not shown) that may detect environment conditions (such as temperature, pressure, presence of material, vibrations, orientation, etc.) surrounding or impacting the colorimetric based sensor 60. Based upon the sensed conditions, the sensor causes the color patch 61 to change to a color that represents the sensed condition; the color of the color patch 61 may change from blue to red when the associated sensor senses a temperature above a predetermined temperature; light emitter 40 and the light detector 50 are arranged so that, when the light emitter 40 is activated, the emitted light 45 illuminates a color patch 61 of colorimetric based sensor 60. The color patch 61 includes indicator material whose color changes in response to the state of an environment or object being measured); and
a registration sensor ([0039] light emitter 40 and the light detector 50) configured to be powered by the harvested energy and when so powered and when the excursion indicator is present, to generate a registration of the excursion indicator ([0036] colorimetric based sensor 60 includes color patch 61 that can modulate the incident light 45 so that the light detector 50 can detect the characteristics of the detected light 65 that represent the state of the color patch 61 of the colorimetric based sensor 60);
wherein when powered by the harvested energy the circuitry is configured to transmit data comprising the registration of the excursion indicator via the NFC antenna ([0035] The electrical signal is received and converted by controller 30 into data representing the characteristics of the detected light 65. The data is conveyed to the microchip 20, which in turn, causes the data to be transmitted through the antenna 10 to the interrogator).
Regarding the amendment: Casey discloses the colorimetric sensor can be immersed in the material of interest, including pharmaceutical applications ([0004]), but doesn’t specify a delivery device comprises a medicament delivery device and the substance comprises a medicament.
In the same field of endeavor, Felber discloses an injection device that uses a sensor configured to detect a signal associated with an amount of medicament within the injection device and to generate a sensor signal based on the signal, a control component coupled to the sensor, the control component configured to harvest energy to process the sensor signal and to generate injection device data, and an antenna coupled to the control component and configured to transmit a radio frequency signal based on the injection device data.
Felber teaches a temperature sensor ([0027] electronic module 105 can include a sensor 122…configured to detect a signal including an indication of medicament amount associated with a function of the injection device 102 and to generate a sensor signal based on the signal…environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device) configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance ([0018] a mechanism configured to harvest energy to power electronic components of the injection device to collect and transmit injection device data). Felber discloses a delivery device (102) comprising the substance ([0022] injection device 102 can include a housing 110 and a needle assembly 115. The housing 110 can contain a medicament reservoir 103; [0027] medicament). Felber discloses a delivery device (102) comprises a medicament delivery device and the substance comprises a medicament ([0022] injection device 102 can include a housing 110 and a needle assembly 115. The housing 110 can contain a medicament reservoir 103).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Casey with Felber using a delivery device with substance in order to increase an accuracy of a result, as suggested by Felber ([0027]).
Regarding Claim 2, Casey doesn’t disclose a memory device in the first embodiment. However, in a second embodiment Casey discloses a memory device that when powered by the harvested energy is configured to store data indicating that the registration sensor has indicated a presence of the temperature excursion ([0045] controller 230, in response to the interrogation request received by the antenna 210, may retrieve collected data from the memory 238; [0071] generating data representing a characteristic of the measured condition of the object of interest and storing the generated data in the memory).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Casey using memory in order to efficiently record numerous conditions that may require attention by a user.
Regarding Claim 3, Casey discloses a controller 230, in response to the interrogation request received by the antenna 210, may retrieve collected data from the memory 238; [0071] generating data representing a characteristic of the measured condition of the object of interest and storing the generated data in the memory).
Regarding Claim 4, Casey discloses the unpowered indicator comprises a chemically activated sensor comprising a chemical that undergoes a change in chemical composition during the temperature excursion ([0003] a colorimetric sensor can be used to assess the instant pH of a system or environment using a number of well-known indicator dyes, which change colors in response to the pH of the system or environment; [0052] colorimetric based sensor system would employ a colored patch of a pH indicator material).
4>Regarding Claim 5, Casey discloses the change in chemical composition results in a color change ([0003] a colorimetric sensor can be used to assess the instant pH of a system or environment using a number of well-known indicator dyes, which change colors in response to the pH of the system or environment; [0052] colorimetric based sensor system would employ a colored patch of a pH indicator material).
Regarding Claim 6, Casey doesn’t disclose a second temperature sensor (that is a sensor powered by harvested energy) configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance; wherein the data transmitted comprises the current temperature.
In the same field of endeavor, Felber discloses an injection device that uses a sensor configured to detect a signal associated with an amount of medicament within the injection device and to generate a sensor signal based on the signal, a control component coupled to the sensor, the control component configured to harvest energy to process the sensor signal and to generate injection device data, and an antenna coupled to the control component and configured to transmit a radio frequency signal based on the injection device data.
Felber discloses a temperature sensor ([0027] electronic module 105 can include a sensor 122…a temperature sensor) configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance ([0018] a mechanism configured to harvest energy to power electronic components of the injection device to collect and transmit injection device data); wherein the data transmitted comprises the current temperature ([0027] electronic module 105 can include a sensor 122, a control component 124, an energy module 126 and an antenna 128. The sensor 122 can be configured to detect a signal including an indication of medicament amount associated with a function of the injection device 102 and to generate a sensor signal based on the signal…sensor 122 can be configured to generate an electric signal that is proportionate to an amount of medicament stored in the medicament reservoir 103 or dispensed by the injection device 102…environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device 102 of FIG. 1 at different locations to detect medicament amount associated data. The sensor 122 can transmit a signal (e.g., a voltage) to the control component 124).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Casey with Felber using another temperature sensor that is powered by harvested energy in order to increase an accuracy of a result, as suggested by Felber ([0027]).
Regarding Claim 7, Casey discloses the NFC antenna is configured to transmit data via NFC communication protocols ([0054] the colorimetric based sensor system may employ an antenna and microchip combination to create a near field communication based colorimetric based sensor system or a Bluetooth™ low energy based colorimetric based sensor system…the microchip compose a low power communication system that can receive signals and energy from an interrogator and broadcast data to the interrogator).
Regarding Claim 11, Felber discloses an injection sensor ([0009] injection device includes: a sensor configured to detect a signal associated with an amount of medicament within the injection device and to generate a sensor signal based on the signal, a control component electrically coupled to the sensor, configured to harvest energy to process the sensor signal and to generate injection device data, and an antenna electrically coupled to the control component and configured to transmit the RF signal based on the injection device data): configured to be powered by the harvested energy; configured when so powered to detect a wet injection ([0010] control component includes an energy harvester configured to harvest energy from at least one of an interrogation signal generated by the computing device and a priming operation of the injection device. In some implementations, the priming operation of the injection device includes a displacement of one of a push button and a piston of the injection device. In some implementations, the control component includes a boost converter configured to increase a voltage level of an energy supplied by the energy harvester); and configured to generate a registration of the wet injection when the wet injection has been detected; and wherein the data transmitted comprises the registration of the wet injection (Claim 30 harvest energy to process the sensor signal and to generate injection device data, wherein the control component comprises an energy harvester configured to harvest the energy in response to receiving a trigger signal, the trigger signal including a priming operation of the injection device and an interrogation signal; and an antenna electrically coupled to the control component and configured to transmit a radio frequency (RF) signal based on the injection device data).
Regarding Claim 12, Felber discloses a displacement sensor: configured to be powered by the harvested energy; configured when so powered to detect a displacement of the displacement sensor; and configured to generate a registration of the displacement when the displacement has been detected; and wherein the data transmitted comprises the registration of the displacement ([0009]-[0010], Claim 30).
12>Regarding Claim 13, Felber discloses the displacement sensor is associated with a cap of a delivery device comprising the substance ([0025] needle 113 can be covered by an inner needle cap 116 and an outer needle cap 117, which in turn can be covered by a cap 119).
6>Regarding Claim 14, Casey discloses an NFC reader configured to provide energy for the NFC antenna to harvest ([0033] antenna 10 harvests energy required for operation of the colorimetric based sensor system 100 from an interrogator (not shown) and retransmits data to the interrogator. The controller 30 routs the power harvested by the antenna 10 and/or control signals to the light emitter 40 and the light detector 50).
Felber teaches the temperature sensor is configured to take plural measurements of the current temperature of the substance when the injection device 102 can transmit to the external device 104 operational data (e.g., date and time of start of usage of injection device 102 and sensor measurements)); wherein the data transmitted by the circuitry comprises the plural measurements of the current temperature of the substance ([0021]); and wherein the
14>Regarding Claim 15, Felber discloses the NFC reader is associated with a storage container configured to store a delivery device comprising the substance ([0023] medicament reservoir 103 can be a conventional, generally cylindrical, disposable container like a cartridge).
8>Regarding Claim 16, Casey disclose a reusable device ([0054] interrogator) configured to operatively interact with the antenna 10 harvests energy required for operation of the colorimetric based sensor system 100 from an interrogator (not shown) and retransmits data to the interrogator. The controller 30 routs the power harvested by the antenna 10 and/or control signals to the light emitter 40 and the light detector 50); and wherein the NFC reader is configured to receive data transmitted by circuitry ([0033]).
Felber discloses a reusable device configured to operatively interact with the delivery device ([0021] injection device 102 can be a pre-filled, disposable injection pen or the injection device 102 can be a reusable injection pen. The injection device 102 can be configured to communicate with the external device 104 (e.g., a smart phone configured to generate RF signals)…the injection device 102 can be configured to harvest energy from the external device 104); wherein the reusable device comprises an NFC reader configured to provide energy for the NFC antenna to harvest when the delivery device is operatively interacting with the reusable device ([0021]); and wherein the NFC reader is configured to receive the data transmitted by the circuitry ([0021] transmit injection device data to the external device 104).
16>Regarding Claim 17, Casey discloses the reusable device further comprises a reusable device data communicator that is in data communication with the NFC reader and also configured to operate using Bluetooth® technology or Wi-Fi technology ([0054] the colorimetric based sensor system may employ an antenna and microchip combination to create a near field communication based colorimetric based sensor system or a Bluetooth™ low energy based colorimetric based sensor system…the microchip compose a low power communication system that can receive signals and energy from an interrogator and broadcast data to the interrogator).
16>Regarding Claim 18, Felber discloses at least one additional sensor configured to be powered by the harvested energy and when so powered is configured to measure a parameter; wherein the data transmitted comprises the parameter ([0027] sensor 122 can include an incremental dosing sensor configured to measure an amount of expelled medicament. In some implementations, the sensor 122 can be configured to include in addition to the sensor configured to detect a signal indicating the amount of medicament an environmental sensor. The environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor).
18>Regarding Claim 19, Casey discloses the parameter comprises pressure or acceleration ([0037] colorimetric based sensor 60 also includes a sensor (not shown) that may detect environment conditions (such as temperature, pressure).
Regarding Claim 24, Casey discloses an apparatus (Abstract, 100 of Fig 1 colorimetric based sensor system), comprising:
an antenna configured (10 of Fig 1 antenna; [0054] the colorimetric based sensor system may employ an antenna and microchip combination to create a near field communication) to harvest energy and when powered by harvested energy to convey the harvested energy ([0033] antenna 10 harvests energy required for operation of the colorimetric based sensor system 100 from an interrogator (not shown) and retransmits data to the interrogator. The controller 30 routs the power harvested by the antenna 10 and/or control signals to the light emitter 40 and the light detector 50);
an unpowered indicator (60, 61 of Fig 1 colorimetric based sensor, color patch) configured to exhibit an excursion indicator only when a temperature excursion of a substance has occurred ([0037]-[0039] colorimetric based sensor 60 also includes a sensor (not shown) that may detect environment conditions (such as temperature, pressure, presence of material, vibrations, orientation, etc.) surrounding or impacting the colorimetric based sensor 60. Based upon the sensed conditions, the sensor causes the color patch 61 to change to a color that represents the sensed condition; the color of the color patch 61 may change from blue to red when the associated sensor senses a temperature above a predetermined temperature; light emitter 40 and the light detector 50 are arranged so that, when the light emitter 40 is activated, the emitted light 45 illuminates a color patch 61 of colorimetric based sensor 60. The color patch 61 includes indicator material whose color changes in response to the state of an environment or object being measured); and
at least one sensor ([0039] light emitter 40 and the light detector 50) configured to be powered by the harvested energy ([0033] controller 30 routs the power harvested by the antenna 10 and/or control signals to the light emitter 40 and the light detector 50), wherein the at least one sensor comprises:
a registration sensor configured to be powered by the harvested energy and when so powered and when the excursion indicator is present, to generate a registration of the excursion indicator ([0036] colorimetric based sensor 60 includes color patch 61 that can modulate the incident light 45 so that the light detector 50 can detect the characteristics of the detected light 65 that represent the state of the color patch 61 of the colorimetric based sensor 60); and
wherein when powered by the harvested energy the apparatus is configured to transmit data comprising the registration of the excursion indicator and the current temperature of the substance ([0035] The electrical signal is received and converted by controller 30 into data representing the characteristics of the detected light 65. The data is conveyed to the microchip 20, which in turn, causes the data to be transmitted through the antenna 10 to the interrogator), but doesn’t specify a second temperature sensor.
Felber discloses a temperature sensor ([0027] electronic module 105 can include a sensor 122…configured to detect a signal including an indication of medicament amount associated with a function of the injection device 102 and to generate a sensor signal based on the signal…environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device) configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance ([0018] a mechanism configured to harvest energy to power electronic components of the injection device to collect and transmit injection device data; [0027] medicament); wherein the data transmitted comprises the current temperature ([0027] electronic module 105 can include a sensor 122, a control component 124, an energy module 126 and an antenna 128. The sensor 122 can be configured to detect a signal including an indication of medicament amount associated with a function of the injection device 102 and to generate a sensor signal based on the signal…sensor 122 can be configured to generate an electric signal that is proportionate to an amount of medicament stored in the medicament reservoir 103 or dispensed by the injection device 102…environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device 102 of FIG. 1 at different locations to detect medicament amount associated data and/or to increase an accuracy of a result associated with the sensor measurements. The sensor 122 can transmit a signal (e.g., a voltage) to the control component 124).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Casey with Felber using another temperature sensor that is powered by harvested energy in order to increase an accuracy of a result, as suggested by Felber ([0027]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Casey and Felber, in view of Kamat et al. (Kamat; AU 2013370281 A1).
8>Regarding Claim 10, Casey doesn’t disclose the delivery device comprises a medicament delivery device trainer.
In the same field of endeavor, Kamat discloses a method of producing, from an adapter, a first wireless signal characterized by a first communication mode with a computing device when a portion of at least one of a medicament delivery device or a simulated medicament delivery is disposed within the adapter. An indication is received when the portion of the medicament delivery device or the simulated medicament delivery device is removed from the adapter.
Kamat discloses delivery device comprises a medicament delivery device trainer ([1273] a monitor device can be configured to establish a piconet with an adapter 120 configured to receive a first medicament delivery device, a simulated medicament delivery device (or trainer) associated with the first medicament delivery device (e.g., a wireless-enabled trainer of the types shown and described herein) and a second medicament delivery device (e.g., a wireless-enabled medicament delivery device)).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Casey with Kamat using a device trainer in order to provide valuable training for users, as suggested by Kamat ([1013]).
Response to Arguments
Applicant's arguments filed 6/23/26 have been fully considered but they are not persuasive for the following reasons:
Arguments:
A. Applicant argues that Casey does not teach or suggest an unpowered indicator configured to exhibit an excursion indicator only when a temperature excursion of the substance has occurred.
It is respectfully submitted that Casey teaches an unpowered indicator (60, 61 of Fig 1 colorimetric based sensor, color patch) configured to exhibit an excursion indicator only when a temperature excursion of a substance has occurred ([0037]-[0039] colorimetric based sensor 60 also includes a sensor (not shown) that may detect environment conditions (such as temperature, pressure, presence of material, vibrations, orientation, etc.) surrounding or impacting the colorimetric based sensor 60. Based upon the sensed conditions, the sensor causes the color patch 61 to change to a color that represents the sensed condition; the color of the color patch 61 may change from blue to red when the associated sensor senses a temperature above a predetermined temperature; light emitter 40 and the light detector 50 are arranged so that, when the light emitter 40 is activated, the emitted light 45 illuminates a color patch 61 of colorimetric based sensor 60. The color patch 61 includes indicator material whose color changes in response to the state of an environment or object being measured).
B. Applicant argues that in the Office Action "Casey doesn't disclose a second temperature sensor configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance...", see paragraph 8. Paragraph 8 of the Office Action includes discussion relating to the Felber reference, wherein, it is indicated that "Felber discloses an injection device that uses a sensor to detect a signal associated with an amount of medicament. This is true. The Office Action further indicates that Felber "discloses a temperature sensor configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance.." and cites to paragraphs [0018] and [0027]. Felber does not teach the use of a temperature sensor as described above. This is the crux of the argument herein. Claim 1 includes a device that has the ability to detect, determine, and deliver information about a medicament delivery device that includes temperature-related information regarding a substance within the medicament delivery device by use of a temperature sensor. Not only is this possible, but it is powered by its harvested energy.
It is respectfully submitted that Felber discloses a temperature sensor ([0027] electronic module 105 can include a sensor 122…configured to detect a signal including an indication of medicament amount associated with a function of the injection device 102 and to generate a sensor signal based on the signal…environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device) configured to be powered by the harvested energy ([0018] a mechanism configured to harvest energy to power electronic components of the injection device) and when so powered is configured to measure a current temperature of the substance ([0018] a mechanism configured to harvest energy to power electronic components of the injection device to collect and transmit injection device data).
Together Casey and Felber teach the limitations recited by Claims 1 and 24, motivation has been provided for the combination, therefore the rejection is proper
C. Applicant argues that the general discussion regarding various sensors that can be used in Felber does not anticipate nor even consider the use of a temperature sensor to detect a temperature of a substance within a medicament delivery device. This temperature sensing is critical prior to use of the device to deliver the injection of the substance into the patient to improve compliance by decreasing discomfort associated with the injection. The combination of Casey and Felber do not discuss nor contemplate this element as claimed in the pending claims.
It is respectfully submitted that Felber teaches a temperature sensor ([0027] electronic module 105 can include a sensor 122…configured to detect a signal including an indication of medicament amount associated with a function of the injection device 102 and to generate a sensor signal based on the signal…environmental sensor can include any of a temperature sensor, a humidity sensor, an air quality sensor, or a light intensity sensor. In some implementations, multiple sensors 122 can be included in the injection device) configured to be powered by the harvested energy and when so powered is configured to measure a current temperature of the substance ([0018] a mechanism configured to harvest energy to power electronic components of the injection device to collect and transmit injection device data). Felber discloses a delivery device (102) comprising the substance ([0022] injection device 102 can include a housing 110 and a needle assembly 115. The housing 110 can contain a medicament reservoir 103; [0027] medicament). Felber discloses a delivery device (102) comprises a medicament delivery device and the substance comprises a medicament ([0022] injection device 102 can include a housing 110 and a needle assembly 115. The housing 110 can contain a medicament reservoir 103).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK S RUSHING whose telephone number is (571)270-5876. The examiner can normally be reached on 10-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Davetta Goins can be reached at 571-272-2957. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK S RUSHING/Primary Examiner, Art Unit 2689
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