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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/03/2026 has been entered.
Response to Amendment
Applicant has canceled claim 52 and has added claims 53-55. Claims 31-45, 50-51, and 53-55 remain pending.
Claims 33, 39-40, and 42-44 were previously rejected under 35 U.S.C. §112(a) for new matter and claim 44 was previously rejected under 35 U.S.C. §112(b) for indefiniteness. These previous rejections are overcome by the present amendment.
Claim Rejections - 35 USC § 103
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.
Claim(s) 31-33 and 35-44 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 20160354555) in view of Kamen et al. (US 20130177455, henceforth Kamen) and Edwards et al. (US 20210257075, henceforth Edwards).
Regarding claim 31, Gibson discloses a device (drug delivery system 100, fig. 1) comprising an electronic circuit (controller 110, fig. 1); a medicament delivery device (drug delivery device 104, fig. 1); a first lock (lock 112, fig. 1) configured to reversibly lock the medicament delivery device (see [0036] and [0037], lock 112 is configured to lock the system 100 by reversibly preventing fluid access from reservoir 102 to drug delivery device 104 which includes needle 344 as in fig. 9; see also [0050]), wherein the electronic circuit comprises a second temperature sensor (temperature sensor 106, fig. 1) configured to measure a second temperature (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102), wherein the second temperature is a temperature of the medicament delivery device (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102 which is a temperature of the delivery device), wherein the electronic circuit is configured to passively remain in a first mode (see fig. 2, the first mode is a mode where controller 110 is not instructing output device 108 to activate and where controller 110 is not instructing lock 112 to activate, and note that the lock is initially unlocked and the output device is initially deactivated) when the second temperature is on a first side of a set temperature (see fig. 2, when the measured temperature T from sensor 106 is below a set upper temperature threshold prior to block 130) and to passively transition to a second mode (see fig. 2, the second mode is a mode where controller 110 is instructing output device 108 to activate and where controller 110 is instructing lock 112 to activate; this is considered to be a passive transition where the user does not need to actively make any changes) when the second temperature transitions to a second side of the set temperature (see fig. 2, when the measured temperature from sensor 106 is above the set upper temperature threshold as in block 130).
Gibson does not disclose the device wherein the electronic circuit comprises a first temperature sensor configured to measure a first temperature, wherein the first temperature is a temperature of a user’s skin, and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature and to transition to a second mode when the first temperature transitions to a second side of the set temperature. Kamen teaches a device comprising an electronic circuit (processor 37, fig. 2) and a medicament delivery device (system 1 of fig. 1) wherein the electronic circuit comprises a first temperature sensor (patient temperature sensor 35, fig. 2) configured to measure a first temperature (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs), wherein the first temperature is a temperature of a user’s skin (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs, meaning it is external to a patient’s body, and thus the measuring or estimating of patient temperature from sensor 35 is understood to be measuring or functionally capable of measuring skin temperature for the patient temperature), and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature (see [0315], the processor 37 passively remains in a state where valve 25 is open to allow pumping when the measured temperature is within an acceptable range below a high temperature threshold which is a first side of a set temperature where the high threshold is the claimed set temperature) and to passively transition to a second mode when the first temperature transitions to a second side of the set temperature (see [0315], the processor 37 transitions to a state of controlling valve 25 to be closed when the patient temperature is outside of the acceptable range; this is considered to be a passive transition where the user does not need to actively make any changes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the patient temperature sensor and electronic circuit configuration of Kamen to the device of Gibson for determining the condition of the patient, compliance with medication, or effect of medication depending on the medication being delivered (see Kamen [0315]). In the modified device, the configuration of the electronic circuit to control drug delivery could be achieved by the processor controlling the lock of Gibson similarly to the valve of Kamen, especially since Gibson already teaches the use of temperature sensors for control of drug delivery (see at least the Abstract of Gibson). Additionally, and in keeping with the teachings of Kamen, the modified device would include and alert or alarm when the threshold is crossed causing the valve to actuate (see at least Kamen [0315]).
Gibson as modified does not disclose the device comprising a second lock configured to irreversibly lock the medicament delivery device. Edwards teaches a medicament delivery device (medical injector 1000, fig. 1A; see also [0268] referring to medicament delivery devices) comprising a second lock (disarming device of [0268]-[0269]) configured to irreversibly lock the medicament delivery device (see [0269], the disarming device operates permanently/irreversibly) based on a temperature measurement ([0269]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second lock of Edwards which is capable of irreversible locking to the device of Gibson for preventing a user from receiving unsafe or ineffective doses of medicament as a result of storage in temperatures outside of the desired range (see at least Edwards [0009], [0268]-[0269]).
{Examiner notes that all subsequent references are directed to Gibson unless otherwise noted.}
Regarding claim 32, Gibson as modified discloses the device of claim 31 wherein the electronic circuit comprises a feedback portion (output device 108, fig. 1; Examiner notes that the description of output device 452 in [0069] is understood to also apply to output device 108 since output device 452 is a detailed embodiment of output device 108 as in [0045]) configured to switch from a first state (deactivated, see fig. 2, which could involve the use of a light as in [0069], which in the modified device would mean that the alert for too high or too low of a patient temperature from Kamen [0315] has not been triggered) to a second state (operational state caused by high temperature, see [0069], which could involve the use of a different light, which in the modified device would be the light to show that the patient temperature is too high) in response to the electronic circuit transitioning from the first mode to the second mode (see Gibson fig. 2 and [0069] and see Kamen [0315] and fig. 2), so as to provide information related to the temperature to a user (Gibson [0069] and Kamen [0315]).
Regarding claim 38, Gibson as modified discloses the device of claim 32 wherein the feedback portion is configured to switch to the second state when at least one of the first temperature and the second temperature is on the second side of the set temperature (see Gibson fig. 2 and see Kamen [0315], output device 108 is activated when the measured patient temperature from Kamen is above the set upper temperature threshold) and is configured to remain in the second state when at least one of the first temperature and the second temperature subsequently returns to a temperature on the first side of the set temperature (the disclosure of Gibson in the embodiment of fig. 2 and the disclosure of Kamen regarding the patient temperature sensor are each silent to any continuous reading capabilities and only shows a single measuring; thus, it is understood that regardless of any later temperature changes in patient temperature, temperature sensor 35 of Kamen in the modified device is not reading the temperature after block 134 of Gibson fig. 2 and thus the device is configured to remain in the locked state if the temperature of the patient returns to a temperature on the first side of the set temperature within the acceptable range or not).
Regarding claim 33, Gibson as modified discloses the device of claim 31 wherein the first lock and the second lock are configured to switch from a first state (deactivated, or unlocked, Gibson fig. 2, which is the initial state; and the second, irreversible lock of Edwards would similarly be unlocked as long as the medicament was properly stored, see Edwards [0268]-[0269]) to a second state (activated, or locked, fig. 2 and [0038] such as in block 134; and irreversibly locked as in Edwards [0269]) in response to the electronic circuit transitioning from the first mode to the second mode (see block 130, fig. 2, and see [0038]; and see Edwards [0269], once the medicament has been stored improperly for too long and the electronic circuit detects this, the second lock is irreversibly activated).
Regarding claim 40, Gibson as modified discloses the device of claim 33 wherein the second lock is configured to switch to the second state when the second temperature is on the second side of the set temperature (see Edwards [0269], the second lock is configured to activate once the storage temperature of the medicament has been outside of a predetermined range for a predetermined period of time) and is configured to remain in the second state when the second temperature subsequently returns to a temperature on the first side of the set temperature (see Edwards [0269], since the lock is irreversible, the future temperature of the medicament delivery device is irrelevant and can still be outside of the predetermined acceptable range or not, the added lock of Edwards will remain in the second, locked state).
Regarding claim 43, Gibson as modified discloses the device of claim 33 wherein the first lock and the second lock are unlocked in the first state (see fig. 2, lock 112 is initially locked in the first state which is shown by it having the be locked in block 134, and thus it was previously unlocked; see also Edwards [0268] and [0269], the second lock is initially unlocked in the first state as it can only be irreversibly locked) and locked in the second state (see fig. 2, lock 112 locks at block 134 as shown; see Edwards [0269], the second lock irreversibly locks in the second state once the medicament delivery device has been improperly stored for a predetermined period of time).
Regarding claim 35, Gibson as modified discloses the device of claim 31 wherein the electronic circuit is configured to passively remain in the first mode when at least one of the first temperature and the second temperature is below the set temperature (see Gibson fig. 2, controller 110 will stay in the first mode and not activate lock 112 or output device 108 if temperature T from sensor 106 is below the set upper temperature threshold; in the modified device, as long as the measured patient temperature was below the upper temperature threshold, the controller would not be configured to change modes) and to transition to the second mode when at least one of the first temperature and the second temperature transitions to above the set temperature (see Gibson fig. 2, controller 110 will change into the second mode and activate lock 112 and output device 108 if temperature T from sensor 106 is rises above the set upper temperature threshold; in the modified device and following the teachings of Kamen [0315], this would mean that once the measured patient temperature is above the upper acceptable threshold, the valve is closed and the lock is activated by the control circuit due to the changing state of the controller).
Regarding claim 41, Gibson as modified discloses the device of claim 31 wherein the medicament delivery device is an auto-injector (see Gibson [0045] and figs. 8-9, the drug delivery device 104 of figs. 1 and 2 is disposable housing 302; this is considered to be an auto-injector because it is capable of using its internal mechanisms to deliver medicament as disclosed in [0049]-[0052]).
Regarding claim 44, Gibson as modified discloses the device of claim 31 wherein the second temperature sensor is configured to measure a temperature reflective of an ambient temperature, of a temperature of the device, or of a medicament within the device (see [0038], a signal from temperature sensor 106 is used to indicate the temperature of the drug in reservoir 102).
Under an alternative interpretation, please see below.
Regarding claim 31, Gibson discloses a device (drug delivery system 100, fig. 1) comprising an electronic circuit (controller 110, fig. 1); a medicament delivery device (drug delivery device 104, fig. 1); a first lock (lock 112, fig. 1) configured to reversibly lock the medicament delivery device (see [0036] and [0037], lock 112 is configured to lock the system 100 by reversibly preventing fluid access from reservoir 102 to drug delivery device 104 which includes needle 344 as in fig. 9; see also [0050]), wherein the electronic circuit comprises a second temperature sensor (temperature sensor 106, fig. 1) configured to measure a second temperature (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102), wherein the second temperature is a temperature of the medicament delivery device (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102 which is a temperature of the delivery device), wherein the electronic circuit is configured to passively remain in a first mode (see fig. 2, the first mode is a mode where controller 110 is not instructing output device 108 to activate and where controller 110 is not instructing lock 112 to activate, and note that the lock is initially unlocked and the output device is initially deactivated) when the second temperature is on a first side of a set temperature (see fig. 2, when the measured temperature T from sensor 106 is above a set lower temperature threshold prior to block 136) and to passively transition to a second mode (see fig. 2, the second mode is a mode where controller 110 is instructing output device 108 to activate and where controller 110 is instructing lock 112 to activate; this is considered to be a passive transition where the user does not need to actively make any changes) when the second temperature transitions to a second side of the set temperature (see fig. 2, when the measured temperature from sensor 106 is below the set lower temperature threshold as in block 138).
Gibson does not disclose the device wherein the electronic circuit comprises a first temperature sensor configured to measure a first temperature, wherein the first temperature is a temperature of a user’s skin, and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature and to transition to a second mode when the first temperature transitions to a second side of the set temperature. Kamen teaches a device comprising an electronic circuit (processor 37, fig. 2) and a medicament delivery device (system 1 of fig. 1) wherein the electronic circuit comprises a first temperature sensor (patient temperature sensor 35, fig. 2) configured to measure a first temperature (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs), wherein the first temperature is a temperature of a user’s skin (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs, meaning it is external to a patient’s body, and thus the measuring or estimating of patient temperature from sensor 35 is understood to be measuring or functionally capable of measuring skin temperature for the patient temperature), and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature (see [0315], the processor 37 passively remains in a state where valve 25 is open to allow pumping when the measured temperature is within an acceptable range above a low temperature threshold which is a first side of a set temperature where the low threshold is the claimed set temperature) and to passively transition to a second mode when the first temperature transitions to a second side of the set temperature (see [0315], the processor 37 transitions to a state of controlling valve 25 to be closed when the patient temperature is outside of the acceptable range below the low threshold; this is considered to be a passive transition where the user does not need to actively make any changes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the patient temperature sensor and electronic circuit configuration of Kamen to the device of Gibson for determining the condition of the patient, compliance with medication, or effect of medication depending on the medication being delivered (see Kamen [0315]). In the modified device, the configuration of the electronic circuit to control drug delivery could be achieved by the processor controlling the lock of Gibson similarly to the valve of Kamen, especially since Gibson already teaches the use of temperature sensors for control of drug delivery (see at least the Abstract of Gibson). Additionally and in keeping with the teachings of Kamen, the modified device would include and alert or alarm when the threshold is crossed causing the valve to actuate (see at least Kamen [0315]).
Gibson as modified does not disclose the device comprising a second lock configured to irreversibly lock the medicament delivery device. Edwards teaches a medicament delivery device (medical injector 1000, fig. 1A; see also [0268] referring to medicament delivery devices) comprising a second lock (disarming device of [0268]-[0269]) configured to irreversibly lock the medicament delivery device (see [0269], the disarming device operates permanently/irreversibly) based on a temperature measurement ([0269]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second lock of Edwards which is capable of irreversible locking to the device of Gibson for preventing a user from receiving unsafe or ineffective doses of medicament as a result of storage in temperatures outside of the desired range (see at least Edwards [0009], [0268]-[0269]).
{Examiner notes that all subsequent references are directed to Gibson unless otherwise noted.}
Regarding claim 36, Gibson as modified discloses the device of claim 31 wherein the electronic circuit is configured to passively remain in the first mode when at least one of the first temperature and the second temperature is above the set temperature (in the modified device, this is the state where the lock of Gibson is unlocked because the measured patient temperature from Kamen is above the low temperature threshold, and the lock is controlled by the controller which is the electronic circuit) and to transition to the second mode when the at least one of the first temperature and the second temperature transitions to below the set temperature (this is a locking due to a low temperature threshold being crossed as in Kamen [0315] which happens due to actuation from the electronic circuit which is the controller).
Under an alternative interpretation, please see below.
Regarding claim 31, Gibson discloses a device (drug delivery system 100, fig. 1) comprising an electronic circuit (controller 110, fig. 1); a medicament delivery device (drug delivery device 104, fig. 1); a first lock (lock 112, fig. 1) configured to reversibly lock the medicament delivery device (see [0036] and [0037], lock 112 is configured to lock the system 100 by reversibly preventing fluid access from reservoir 102 to drug delivery device 104 which includes needle 344 as in fig. 9; see also [0050]), wherein the electronic circuit comprises a second temperature sensor (temperature sensor 106, fig. 1) configured to measure a second temperature (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102), wherein the second temperature is a temperature of the medicament delivery device (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102 which is a temperature of the delivery device), wherein the electronic circuit is configured to passively remain in a first mode (see fig. 2, the first mode is a mode where controller 110 is not instructing output device 108 to activate and where controller 110 is not instructing lock 112 to activate, and note that the lock is initially unlocked and the output device is initially deactivated) when the second temperature is on a first side of a set temperature (see fig. 2, when the measured temperature T from sensor 106 is above a set lower temperature threshold prior to block 136) and to passively transition to a second mode (see fig. 2, the second mode is a mode where controller 110 is instructing output device 108 to activate and where controller 110 is instructing lock 112 to activate; this is considered to be a passive transition where the user does not need to actively make any changes) when the second temperature transitions to a second side of the set temperature (see fig. 2, when the measured temperature from sensor 106 is below the set lower temperature threshold as in block 138).
Gibson does not disclose the device wherein the electronic circuit comprises a first temperature sensor configured to measure a first temperature, wherein the first temperature is a temperature of a user’s skin, and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature and to transition to a second mode when the first temperature transitions to a second side of the set temperature. Kamen teaches a device comprising an electronic circuit (processor 37, fig. 2) and a medicament delivery device (system 1 of fig. 1) wherein the electronic circuit comprises a first temperature sensor (patient temperature sensor 35, fig. 2) configured to measure a first temperature (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs), wherein the first temperature is a temperature of a user’s skin (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs, meaning it is external to a patient’s body, and thus the measuring or estimating of patient temperature from sensor 35 is understood to be measuring or functionally capable of measuring skin temperature for the patient temperature), and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature (see [0315], the processor 37 passively remains in a state where valve 25 is open to allow pumping when the measured temperature is within an acceptable range above a low temperature threshold which is a first side of a set temperature where the low threshold is the claimed set temperature) and to passively transition to a second mode when the first temperature transitions to a second side of the set temperature (see [0315], the processor 37 transitions to a state of controlling valve 25 to be closed when the patient temperature is outside of the acceptable range below the low threshold; this is considered to be a passive transition where the user does not need to actively make any changes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the patient temperature sensor and electronic circuit configuration of Kamen to the device of Gibson for determining the condition of the patient, compliance with medication, or effect of medication depending on the medication being delivered (see Kamen [0315]). In the modified device, the configuration of the electronic circuit to control drug delivery could be achieved by the processor controlling the lock of Gibson similarly to the valve of Kamen, especially since Gibson already teaches the use of temperature sensors for control of drug delivery (see at least the Abstract of Gibson). Additionally and in keeping with the teachings of Kamen, the modified device would include and alert or alarm when the threshold is crossed causing the valve to actuate (see at least Kamen [0315]).
Gibson as modified does not disclose the device comprising a second lock configured to irreversibly lock the medicament delivery device. Edwards teaches a medicament delivery device (medical injector 1000, fig. 1A; see also [0268] referring to medicament delivery devices) comprising a second lock (disarming device of [0268]-[0269]) configured to irreversibly lock the medicament delivery device (see [0269], the disarming device operates permanently/irreversibly) based on a temperature measurement ([0269]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second lock of Edwards which is capable of irreversible locking to the device of Gibson for preventing a user from receiving unsafe or ineffective doses of medicament as a result of storage in temperatures outside of the desired range (see at least Edwards [0009], [0268]-[0269]).
{Examiner notes that all subsequent references are directed to Gibson unless otherwise noted.}
Regarding claim 32, Gibson as modified discloses the device of claim 31 wherein the electronic circuit comprises a feedback portion (output device 108, fig. 1; Examiner notes that the description of output device 452 in [0069] is understood to also apply to output device 108 since output device 452 is a detailed embodiment of output device 108 as in [0045]) configured to switch from a first state (deactivated, see fig. 2, which could involve the use of a light as in [0069], which in the modified device would mean that the alert for too high or too low of a patient temperature from Kamen [0315] has not been triggered) to a second state (operational state caused by high temperature, see [0069], which could involve the use of a different light, which in the modified device would be the light to show that the patient temperature is too high) in response to the electronic circuit transitioning from the first mode to the second mode (see Gibson fig. 2 and [0069] and see Kamen [0315] and fig. 2), so as to provide information related to the temperature to a user (Gibson [0069] and Kamen [0315]).
Regarding claim 37, Gibson as modified discloses the device of claim 32 wherein the feedback portion is configured to switch to the second state when at least one of the first temperature and the second temperature is on the second side of the set temperature (see fig. 6, [0043], [0069], lock 112 is activated when temperature T, which would be replaced by the patient temperature from Kamen in the modified device, is below the set lower temperature threshold at block 240) and is configured to return to the first state when at least one of the first temperature and the second temperature subsequently returns to a temperature on the first side of the set temperature (see fig. 6, after time has passed and once the heater has been activated at block 244, the patient temperature is again checked to see if the temperature is above the set lower temperature threshold, or on the first side of the set temperature is claimed, and if so, controller 110 switches to unlock lock 112 at block 248; since this is a change in state, it is understood that the user would also receive the appropriate feedback as in [0043], [0044], and [0069]).
Regarding claim 33, Gibson as modified discloses the device of claim 31 wherein the first lock and the second lock are configured to switch from a first state (the first lock is deactivated, or unlocked, fig. 6, which is the initial state; the second lock of Edwards is unlocked in the first state) to a second state (activated, or locked, fig. 6, at blocks 238 and 240; the second lock of Edwards is locked in the second state once the circuit has changed modes due to improper storage outside of the predetermined acceptable range for a predetermined period of time, see Edwards [0269]) in response to the electronic circuit transitioning from the first mode to the second mode (see fig. 6 and see [0043]; see Edwards [0269] regarding the second lock).
Regarding claim 39, Gibson as modified discloses the device of claim 33 wherein the first lock is configured to switch to the second state when the second temperature is on the second side of the set temperature (see fig. 6, [0043], [0069], output device 108 is activated when temperature T is below the set lower temperature threshold at block 238) and is configured to return to the first state when the second temperature subsequently returns to a temperature on the first side of the set temperature (see fig. 6, once the heater has been activated at block 244, temperature T from temperature sensor 106 is again checked to see if the temperature is above the set lower temperature threshold, or on the first side of the set temperature is claimed, and if so, controller 110 switches to unlock lock 112 at block 248; note that the second lock remains activated since it is irreversibly locked in this state).
Under an alternative interpretation, please see below.
Regarding claim 31, Gibson discloses a device (drug delivery system 100, fig. 1) comprising an electronic circuit (controller 110, fig. 1); a medicament delivery device (drug delivery device 104, fig. 1); a first lock (lock 112, fig. 1) configured to reversibly lock the medicament delivery device (see [0036] and [0037], lock 112 is configured to lock the system 100 by reversibly preventing fluid access from reservoir 102 to drug delivery device 104 which includes needle 344 as in fig. 9; see also [0050]), wherein the electronic circuit comprises a second temperature sensor (temperature sensor 106, fig. 1) configured to measure a second temperature (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102), wherein the second temperature is a temperature of the medicament delivery device (see [0038] and [0039], sensor 106 is used to measure the temperature of reservoir 102 which is a temperature of the delivery device), wherein the electronic circuit is configured to passively remain in a first mode (see fig. 7, the first mode is a mode where controller 110 is instructing output device 108 to activate and where controller 110 is instructing lock 112 to activate, and note that the lock is initially locked and the output device is initially activated in the chosen embodiment as this is disclosed in [0077] as an option) when the second temperature is on a first side of a set temperature (see fig. 7, when the measured temperature T from sensor 106 is below a set lower temperature threshold in the middle column of the chart) and to passively transition to a second mode (see fig. 7, the second mode is a mode where controller 110 is instructing output device 108 to deactivate and where controller 110 is instructing lock 112 to unlock; this is considered to be a passive transition where the user does not need to actively make any changes) when the second temperature transitions to a second side of the set temperature (once the heater has been activated as in fig. 7, the lock is unlocked as shown in fig. 7; it is understood that this is accompanied by a signal from the output device as in [0042], [0044], and [0069]).
Gibson does not disclose the device wherein the electronic circuit comprises a first temperature sensor configured to measure a first temperature, wherein the first temperature is a temperature of a user’s skin, and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature and to transition to a second mode when the first temperature transitions to a second side of the set temperature. Kamen teaches a device comprising an electronic circuit (processor 37, fig. 2) and a medicament delivery device (system 1 of fig. 1) wherein the electronic circuit comprises a first temperature sensor (patient temperature sensor 35, fig. 2) configured to measure a first temperature (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs), wherein the first temperature is a temperature of a user’s skin (see [0305] and [0315], the temperature sensor 35 is a part of monitor 26 which monitors the site at which injection occurs, meaning it is external to a patient’s body, and thus the measuring or estimating of patient temperature from sensor 35 is understood to be measuring or functionally capable of measuring skin temperature for the patient temperature), and wherein the electronic circuit is configured to passively remain in a first mode when the first temperature is on a first side of a set temperature (see [0315], the processor 37 passively remains in a state where valve 25 is open to allow pumping when the measured temperature is within an acceptable range above a low temperature threshold which is a first side of a set temperature where the low threshold is the claimed set temperature) and to passively transition to a second mode when the first temperature transitions to a second side of the set temperature (see [0315], the processor 37 transitions to a state of controlling valve 25 to be closed when the patient temperature is outside of the acceptable range below the low threshold; this is considered to be a passive transition where the user does not need to actively make any changes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the patient temperature sensor and electronic circuit configuration of Kamen to the device of Gibson for determining the condition of the patient, compliance with medication, or effect of medication depending on the medication being delivered (see Kamen [0315]). In the modified device, the configuration of the electronic circuit to control drug delivery could be achieved by the processor controlling the lock of Gibson similarly to the valve of Kamen, especially since Gibson already teaches the use of temperature sensors for control of drug delivery (see at least the Abstract of Gibson). Additionally, and in keeping with the teachings of Kamen, the modified device would include and alert or alarm when the threshold is crossed causing the valve to actuate (see at least Kamen [0315]).
Gibson as modified does not disclose the device comprising a second lock configured to irreversibly lock the medicament delivery device. Edwards teaches a medicament delivery device (medical injector 1000, fig. 1A; see also [0268] referring to medicament delivery devices) comprising a second lock (disarming device of [0268]-[0269]) configured to irreversibly lock the medicament delivery device (see [0269], the disarming device operates permanently/irreversibly) based on a temperature measurement ([0269]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second lock of Edwards which is capable of irreversible locking to the device of Gibson for preventing a user from receiving unsafe or ineffective doses of medicament as a result of storage in temperatures outside of the desired range (see at least Edwards [0009], [0268]-[0269]).
{Examiner notes that all subsequent references are directed to Gibson unless otherwise noted.}
Regarding claim 33, Gibson as modified discloses the device of claim 31 wherein the first lock and the second lock are configured to switch from a first state (activated, or locked, fig. 7, which is the initial state; the second lock is unlocked in the first state if the device has been properly stored, see Edwards [0268-[0269]) to a second state (deactivated, or unlocked, fig. 7; the second lock is locked in the second state if the device has been improperly stored, see Edwards [0268-[0269]) in response to the electronic circuit transitioning from the first mode to the second mode (see fig. 7 and see [0044]; and see Edwards [0269] regarding the functionality of the second lock).
Regarding claim 42, Gibson as modified discloses the device of claim 33 wherein the first lock is unlocked in the second state (the second state includes lock 112 being unlocked, see fig. 7 and claim 31 above) and locked in the first state (the first state includes lock 112 being locked, see fig. 7 and claim 31 above).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 20160354555) in view of Kamen et al. (US 20130177455, henceforth Kamen) and Edwards et al. (US 20210257075, henceforth Edwards) as applied to claim 31 above under the initial embodiment of claim 31, and further in view of Melzi (US 20200327974).
Regarding claim 34, Gibson as modified discloses the device with the electronic circuit a recordal portion comprising memory and a processor and the processor receiving signals from the temperature sensor ([0037]).
Gibson does not disclose that the recordal portion is to record when the electronic circuit transitions from the first mode to the second mode. Melzi teaches a device (supplementary device 200, fig. 2a) comprising a recordal portion (memory, [0064] and [0110]) where the recordal portion is used to record measurements from a temperature sensor ([0110]). Melzi also teaches that these recordings can be sent to an external device ([0110]), and that data sent to the external device can be used to combine data across multiple disposable devices for a single user ([0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the recordal portion of Gibson to record when the electronic circuit transitions from the first mode to the second mode as this is part of the temperature information collected by the sensor as in Melzi and to have then transmitted said data to an external device as in Melzi for the benefit of allowing the data from multiple disposable drug delivery devices of Gibson to be combined for a single user as in Melzi ([0012]), as this is desirable to keep track of data(Melzi [0010]).
Claim(s) 45 and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 20160354555) in view of Kamen et al. (US 20130177455, henceforth Kamen) and Edwards et al. (US 20210257075, henceforth Edwards) as applied to claim 31 above, and further in view of Shor et al. (US 20190009019, henceforth Shor).
Regarding claims 45 and 51, Gibson as modified discloses the device of claim 31.
Gibson as modified does not disclose the device wherein the first temperature sensor is on an outer portion of the device or is configured to contact the user’s skin. Shor teaches a medicament delivery device which is attachable to skin (device 100, fig. 27E) comprising a skin temperature sensor (sensor 233b, fig. 27E) which is on an outer portion of the device (see fig. 27E) and is configured to contact the skin of the user (see at least [0028], [0035], [0192], [0198], and fig. 27E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the temperature sensor as claimed as Shor teaches this to be an art effective way of arranging a sensor which is configured to measure user skin temperature (see at least Shor [0198]), and further because arranging the sensor as claimed would have yielded the predictable result of a sensor which is capable of coming into contact with skin such as to be able to measure its temperature.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibson (US 20160354555) in view of Kamen et al. (US 20130177455, henceforth Kamen) and Edwards et al. (US 20210257075, henceforth Edwards) as applied to claim 31 above under the initial embodiment of claim 31, and further in view of Platonoff et al. (US 20200405967, henceforth Platonoff).
Regarding claim 50, Gibson as modified discloses the device wherein the electronic circuit is configured to be powered by a battery (see [0032]).
Gibson does not disclose the device wherein the electronic circuit is configured to passively remain in a first mode without periodically measuring the temperature. Platonoff teaches a first mode (sleep mode, [0062]) which does not include periodically measuring the temperature ([0062]), and that such a first mode is beneficial as it consumes less energy from a battery over time ([0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first mode of Gibson to not periodically measure the temperature as in Platonoff for the benefit of preserving battery life over time (see Platonoff [0062] and [0054]). In the modified device, the temperature could be measured after another action is taken by the user, such as a waking action as in Platonoff ([0062]) to signal the start of use.
Claim(s) 53-55 is/are rejected under 35 U.S.C. 103 as being unpatentable Gibson (US 20160354555) in view of Kamen et al. (US 20130177455, henceforth Kamen) and Edwards et al. (US 20210257075, henceforth Edwards) as applied to claim 31 above under the initial embodiment of claim 31, and further in view of Flaherty (US 20020169439, henceforth Flaherty).
Regarding claim 53, Gibson as modified discloses the device of claim 31 comprising the electronic circuit (controller 110, fig. 1).
Gibson as modified does not disclose the device wherein the electronic circuit further comprises: at least one resistor; and at least one transistor. Flaherty teaches that electronic circuits in medical devices are known to comprise microprocessors, digital and analog integrated circuits, resistors, capacitors, transistors and other semiconductors and other electronic components ([0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included resistors and transistors as part of the electronic circuit of Gibson as Flaherty teaches these components to be well known in the art as part of electronic circuitry used for processors to allow a user to program the device as needed (Flaherty [0042]), because one of ordinary skill in the art would have been able to select the proper electronic circuitry components to achieve the electrical requirements of the control circuitry, and because including the components would have yielded a predictable result of an operable processor since Flaherty teaches the components to be well known to those of ordinary skill in the art as part of processors ([0042]).
Regarding claim 54, Gibson as modified discloses the device of claim 53 wherein the electronic circuit is configured to transition between the first mode and the second mode in response to a physical switching of the transistor (in the modified device, the transistor of Gibson as included by Flaherty is considered to have a physical switching where it is included in the electronic circuit which will see changing passing of electrons in the circuitry as a result of the digital determination to change from the first mode to the second mode as a result of the measured temperature being outside of the designated temperature boundaries; this changing of modes is considered to be a physical switching as the logic of the controller needed to activate the locks will necessitate a changing in the electron current flows within the electronic circuit to relay digital signals).
Regarding claim 55, Gibson as modified discloses the device of claim 31 comprising the electronic circuit (controller 110, fig. 1).
Gibson as modified does not disclose the device wherein the electronic circuit is analog. Flaherty teaches that electronic circuits in medical devices are known to comprise microprocessors, digital and analog integrated circuits, resistors, capacitors, transistors and other semiconductors and other electronic components ([0042]), and that analog circuits can be used to receive inputs from sensors ([0066]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included analog integrated circuits as Flaherty teaches these components to be well known in the art as part of electronic circuitry used for processors to allow a user to program the device as needed (Flaherty [0042]), because one of ordinary skill in the art would have been able to select the proper electronic circuitry components to achieve the electrical requirements of the control circuitry, and to receive data from sensors (Flaherty [0066]).
Response to Arguments
Applicant's arguments filed 03/19/2206 and entered 04/03/2026 have been fully considered but they are not persuasive.
Applicant has argued that the following of computer-executable instructions as in Gibson as modified during the switching of the electronic circuit does not disclose a passive transitioning of the electronic circuit from the first mode to the second mode as claimed (“and wherein the electronic circuit is configured to passively remain in a first mode when at least one of the first temperature and the second temperature is on a first side of a set temperature and to passively transition to a second mode when at least one of the first temperature and the second temperature transitions to a second side of the set temperature”). Examiner respectfully disagrees. The changing from the first mode to the second mode of Gibson as modified is a passive transitioning as claimed where it does not require external input from a user; since the transitioning between modes in Gibson as modified is automatic (done entirely by the processor which is the electronic circuit) and does not require any user intervention, it is considered to be a passive transition as claimed. Further differentiation could be made to overcome the transitioning of Gibson as modified by calling out that the electronic circuit which is configured for the passive transition consists of an analog circuit and does not rely on digital conversion of the temperature to allow for passive transitioning.
Thus, Applicant’s arguments are respectfully found unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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