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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 5 March 2024 and 18 October 2024, have been considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 59-79 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Davis et al. (US 2020/0030544 A1).
Regarding claim 59, Davis et al. discloses an injection device assembly comprising: a housing (101 Fig 1); a syringe assembly (104) at least partially disposed within the housing, the syringe assembly including a barrel configured to hold a medication ([0041] “the vial of medicament.”); a drive mechanism (103) configured to dispense the medication from the barrel when activated ([0027] “injected into a user via a syringe 104 and a dispensing mechanism 103, such as a plunger or automatic pressure dispenser”); a thermal ballast ([0035] “a temperature analog 402”); a temperature sensor (107) configured to measure a temperature of the thermal ballast ([0033] “Once activated, the temperature sensor 107 may continuously monitor the temperature of the medicament and/or a temperature analog of the medicament”); and at least one processing circuit (the circuit made up of initiator 106, controller 105, temperature sensor 107, timer 108, and indicator 109, this circuit includes a processor [0040] “a printed circuit board (PCB) assembly 1201 with a processor,”) operably coupled to the temperature sensor, configured to estimate a temperature of the medication in the barrel based on the temperature of the thermal ballast ([0034] “the temperature sensor may be activated through the use of an initiator tied to a controller and may begin measuring the medicament temperature”, [0035] “measuring the temperature of the temperature analog 402 may provide a representation of the dynamic temperature of the medicament as both are heated or cooled”).
Regarding claim 60, Davis et al. discloses the injection device assembly of claim 59. Davis et al. further discloses wherein the at least one processing circuit estimates the temperature of the medication in the barrel by assuming that the temperature of the medication is equal to the temperature of the thermal ballast ([0035] “measuring the temperature of the temperature analog 402 may provide the same or substantially the same temperature reading had the temperature of the medicament been measured directly instead”, “measuring the temperature of the temperature analog 402 may provide a representation of the dynamic temperature of the medicament as both are heated or cooled”, the temperature of the temperature analog is an estimate of the temperature of the medication).
Regarding claim 61, Davis et al. discloses the injection device assembly of claim 59. Davis et al. further discloses wherein the thermal ballast has a thermal time constant that is within 5% of a thermal time constant of the medication in the barrel ([0035] “the temperature analog 402 may have the same time-dependent heat transfer properties of the medicament”, “if the medicament warms from freezing to room temperature in 20 minutes, the temperature analog 402 may also warm from freezing to room temperature in 20 minutes.”, where both the medicament and the analog have the same time-dependent heat transfer properties and both warm to room temperature in 20 minutes, they have the same thermal time constant which is within 5%).
Regarding claim 62, Davis et al. discloses the injection device assembly of claim 59. Davis et al. further discloses wherein the thermal ballast has a thermal time constant that is within 2% of a thermal time constant of the medication in the barrel ([0035] “the temperature analog 402 may have the same time-dependent heat transfer properties of the medicament”, “if the medicament warms from freezing to room temperature in 20 minutes, the temperature analog 402 may also warm from freezing to room temperature in 20 minutes.”, where both the medicament and the analog have the same time-dependent heat transfer properties and both warm to room temperature in 20 minutes, they have the same thermal time constant which is within 2%).
Regarding claim 63, Davis et al. discloses the injection device assembly of claim 59. Davis et al. further discloses wherein the thermal ballast is configured such that, when the injection device assembly is brought from an environment at a storage temperature to an environment at a room temperature that is warmer than the storage temperature, the temperature of the thermal ballast does not differ by more than two degrees Celsius from the temperature of the medication in the barrel at any time while the thermal ballast and the medication are warming from the storage temperature to the room temperature ([0035] “the temperature analog 402 may have the same time-dependent heat transfer properties of the medicament”, “if the medicament warms from freezing to room temperature in 20 minutes, the temperature analog 402 may also warm from freezing to room temperature in 20 minutes.”, where the time-dependent heat transfer properties are the same, the temperatures would not differ by more than two degrees).
Regarding claim 64, Davis et al. discloses the injection device assembly of claim 63. Davis et al. further discloses wherein the storage temperature is between 2 and 8 degrees Fahrenheit, and the room temperature is between 18 and 24 degrees Fahrenheit (because Davis et al. describes the time-dependent heat transfer properties as being the same, the functional claim limitations of the temperatures not differing by more than two degrees as recited in claim 63 would also be achieved with the storage and room conditions as recited in this claim 64).
Regarding claim 65, Davis et al. discloses the injection device assembly of claim 59. Davis et al. further discloses wherein the thermal ballast comprises at least a portion of a printed circuit board (PCB) ([0037] “the temperature analog 402 may be directly mounted to the PCB 404”, when the temperature analog is mounted to the PCB, the PCB would necessarily impart some thermal effect to the temperature analog, as such, at least a portion of the PCB can be interpreted as part of the thermal ballast).
Regarding claim 66, Davis et al. discloses the injection device assembly of claim 59. Davis et al. further discloses wherein the at least one processing circuit is configured to report whether the estimated temperature of the medication in the barrel satisfies ideal injection temperature parameters to a user ([0034] “the temperature sensor may communicate with the controller to notify when the medicament is at the proper designated temperature and is ready for use 303. The controller may then communicate with the alert (audio and/or visual) system 304, and the user may then deliver the medicament 305.”) via one or more light-emitting diodes mounted on the injection device assembly ([0039] “after reaching a pre-set temperature, one or more of LEDs 1001 […] may be activated to indicate to the user that the device is ready to use.”, 1001 Fig 10).
Regarding claim 67, Davis et al. discloses the injection device assembly of claim 66. Davis et al. further discloses wherein the estimated temperature of the medication satisfies the ideal injection temperature parameters when the estimated temperature is within an ideal temperature range ([0029] “to warm up to the appropriate range of temperature”).
Regarding claim 68, Davis et al. discloses the injection device assembly of claim 66. Davis et al. further discloses wherein the estimated temperature of the medication satisfies the ideal injection temperature parameters when the estimated temperature is above a minimum temperature threshold ([0011] “emitting a notification from the ready-to-use indicator that a preset temperature of the temperature analog has been reached”, the preset temperature is a minimum temperature threshold, the device is ready to use after it has reached a preset temperature. In the context of the device warming up from frozen to room temperature, the “reached” temperature is a minimum temperature threshold).
Regarding claim 79, Davis et al. discloses the injection device assembly of claim 59. Davis er al. further discloses further comprising the medication (102 Fig 1).
Regarding claim 69, Davis et al. discloses a method for estimating a temperature of a medication in an injection device assembly, the method comprising: providing the injection device assembly (Fig 1), the assembly having: a housing (101 Fig 1); a syringe assembly (104) at least partially disposed within the housing, the syringe assembly including a barrel configured to hold the medication ([0041] “the vial of medicament.”); a drive mechanism (103) configured to dispense the medication from the barrel when activated ([0027] “injected into a user via a syringe 104 and a dispensing mechanism 103, such as a plunger or automatic pressure dispenser”); a thermal ballast ([0035] “a temperature analog 402”); a temperature sensor (107) configured to measure a temperature of the thermal ballast ([0033] “Once activated, the temperature sensor 107 may continuously monitor the temperature of the medicament and/or a temperature analog of the medicament”); and receiving, at one or more processing circuit (the circuit made up of initiator 106, controller 105, temperature sensor 107, timer 108, and indicator 109, this circuit includes a processor [0040] “a printed circuit board (PCB) assembly 1201 with a processor,”) the measured temperature of the thermal ballast ([0034] “the temperature sensor may be activated through the use of an initiator tied to a controller and may begin measuring the medicament temperature”, [0035] “measuring the temperature of the temperature analog 402 may provide a representation of the dynamic temperature of the medicament as both are heated or cooled”); and estimating the temperature of the medication in the barrel based on the measured temperature of the thermal ballast ([0035] “measuring the temperature of the temperature analog 402 may provide a representation of the dynamic temperature of the medicament as both are heated or cooled”, the temperature of the temperature analog is an estimate of the temperature of the medication.
Regarding claim 70, Davis et al. discloses the method of claim 69. David et al. further discloses wherein the one or more processing circuits estimates the temperature of the medication in the barrel by assuming that the temperature of the medication is equal to the temperature of the thermal ballast. ([0035] “measuring the temperature of the temperature analog 402 may provide the same or substantially the same temperature reading had the temperature of the medicament been measured directly instead”, “measuring the temperature of the temperature analog 402 may provide a representation of the dynamic temperature of the medicament as both are heated or cooled”).
Regarding claim 71, Davis et al. discloses the method of claim 69. Davis et al. further discloses wherein the thermal ballast has a thermal time constant that is within 5% of a thermal time constant of the medication in the barrel ([0035] “the temperature analog 402 may have the same time-dependent heat transfer properties of the medicament”, “if the medicament warms from freezing to room temperature in 20 minutes, the temperature analog 402 may also warm from freezing to room temperature in 20 minutes.”, where both the medicament and the analog have the same time-dependent heat transfer properties and both warm to room temperature in 20 minutes, they have the same thermal time constant which is within 5%).
Regarding claim 72, Davis et al. discloses the method of claim 69. Davis et al. further discloses wherein the thermal ballast has a thermal time constant that is within 2% of a thermal time constant of the medication in the barrel ([0035] “the temperature analog 402 may have the same time-dependent heat transfer properties of the medicament”, “if the medicament warms from freezing to room temperature in 20 minutes, the temperature analog 402 may also warm from freezing to room temperature in 20 minutes.”, where both the medicament and the analog have the same time-dependent heat transfer properties and both warm to room temperature in 20 minutes, they have the same thermal time constant which is within 2%).
Regarding claim 73, Davis et al. discloses the method of claim 69. Davis et al. further discloses wherein the thermal ballast is configured such that, when the injection device assembly is brought from an environment at a storage temperature to an environment at a room temperature that is warmer than the storage temperature, the temperature of the thermal ballast does not differ by more than two degrees Celsius from the temperature of the medication in the barrel at any time while the thermal ballast and the medication are warming from the storage temperature to the room temperature ([0035] “the temperature analog 402 may have the same time-dependent heat transfer properties of the medicament”, “if the medicament warms from freezing to room temperature in 20 minutes, the temperature analog 402 may also warm from freezing to room temperature in 20 minutes.”, where the time-dependent heat transfer properties are the same, the temperatures would not differ by more than two degrees).
Regarding claim 74, Davis et al. discloses the method of claim 73. Davis et al. further discloses wherein the storage temperature is between 2 and 8 degrees Fahrenheit, and the room temperature is between 18 and 24 degrees Fahrenheit (because Davis et al. describes the time-dependent heat transfer properties as being the same, the functional claim limitations of the temperatures not differing by more than two degrees as recited in claim 73 would also be achieved with the storage and room conditions as recited in this claim 74).
Regarding claim 75, Davis et al. discloses the method of claim 69. Davis et al. further discloses wherein the thermal ballast comprises at least a portion of a printed circuit board (PCB) ([0037] “the temperature analog 402 may be directly mounted to the PCB 404”, when the temperature analog is mounted to the PCB, the PCB would necessarily impart some thermal effect to the temperature analog, as such, at least a portion of the PCB can be interpreted as part of the thermal ballast).
Regarding claim 76, Davis et al. discloses the method of claim 69. Davis et al. further discloses further comprising reporting whether the estimated temperature of the medication in the barrel satisfies ideal injection temperature parameters to a user ([0034] “the temperature sensor may communicate with the controller to notify when the medicament is at the proper designated temperature and is ready for use 303. The controller may then communicate with the alert (audio and/or visual) system 304, and the user may then deliver the medicament 305.”) via one or more light-emitting diodes mounted on the injection device assembly ([0039] “after reaching a pre-set temperature, one or more of LEDs 1001 […] may be activated to indicate to the user that the device is ready to use.”, 1001 Fig 10).
Regarding claim 77, Davis et al. discloses the method of claim 76. Davis et al. further discloses wherein the estimated temperature of the medication satisfies the ideal injection temperature parameters when the estimated temperature is within an ideal temperature range ([0029] “to warm up to the appropriate range of temperature”).
Regarding claim 78, Davis et al. discloses the method of claim 76. Davis et al. further discloses wherein the estimated temperature of the medication satisfies the ideal injection temperature parameters when the estimated temperature is above a minimum temperature threshold ([0011] “emitting a notification from the ready-to-use indicator that a preset temperature of the temperature analog has been reached”, the preset temperature is a minimum temperature threshold, the device is ready to use after it has reached a preset temperature. In the context of the device warming up from frozen to room temperature, the “reached” temperature is a minimum temperature threshold).
Conclusion
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/A.E.V./ /BHISMA MEHTA/ Examiner, Art Unit 3783 Supervisory Patent Examiner, Art Unit 3783
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