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 .
Response to Amendment
The amendment filed February 04, 2026 has been entered. Claims 8, 16, and 36-38 remain pending in the application. Claims 1-7, 9-15, and 17-35 have been cancelled. Applicant’s amendments to the claims have overcome the objections previously set forth in the Non-Final Office Action mailed December 04, 2025.
Claim Objections
Claim 38 is objected to because there is a typo regarding “…indicating that appropriate temperature…” as opposed to “…indicating that an appropriate temperature…” in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 recites the limitation "the difference between consecutive pre- and post-temperatures successively obtained by the first temperature sensor" in lines 1-3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 8, 16, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Dahmani et al. (US 20200297933) in view of Tachibana (US 20050029277) in further in view of Hanada (WO 2013073650, with citations to provided English Translation cited on PTO-892), further in view of Davis et al. (US 20200030544), and in further view of Marlin et al. (US 20180236181).
Regarding claim 8, Dahmani discloses a drug injection device (injection assembly 10), comprising:
a device housing (injector 100) having a housing space (interior cavity 102) that houses at least a portion of a cassette (cassette 230 of dose module 200) that houses a drug cartridge (syringe 210) having a first temperature sensor (thermal coupling element 240 coupled to thermal sensor 160) and an RF tag (RFID tag 238), or at least a portion of a drug cartridge having a first temperature sensor and an RF tag and being not housed in the cassette, and a housing opening that communicates with the housing space (opening into interior cavity 102; Figure 5);
a piston (piston head 114 attached to lead screw 124) supported so that the piston can move into the housing space (“When injection instructions are calculated and/or determined, the drive mechanism can engage the plunger 214 of the dose module 200 via contact of a piston head 114 through the closable access 232 of the cassette 210.” [0031]);
a motor (motor 120) configured to drive the piston (“the motor(s) 120 may be connected to an actuator 122 comprising a lead screw 124 (e.g., drive piston) and lead nut 126.” [0028]);
a motor driver configured to generate a drive signal for driving the motor (“the motor speed can be actively controlled by the control system through, for example, a closed loop feedback mechanism in order to maintain a smooth flow rate at the specified injection speed.” [0035]; see also control system environment 900 [0044]; Figure 11;
an RF reader (RFID reader 154) arranged adjacent to the housing space (“the injector 100 can include an RFID reader 154 for wirelessly reading the identification information on the RFID tag 238 on the cassette 230 (FIG. 4A).” [0029]);
a memory storing control information for controlling the motor for each of a plurality of drugs, wherein the control information of each drug includes a set of control parameters of the motor for each of a plurality of temperature ranges (“the control system 150 includes memory for storing data related to doses received, injections performed, user-generated injection parameter, etc. For example, the memory can store programs specific for a medicament's rheology. The control system 150 can use input from sensors, such as the thermal sensor 160, in combination with the stored rheology programs in order to calculate a medicament's viscosity. The memory also stores programs for operating the injector 100, such as injection force calculation and corresponding motor speed.” [0030]; “drug-specific rheology programs can be stored within the processor's internal memory and can be used in combination with the concentration of the dose, temperature of the syringe, and selected flow rate in order to calculate viscosity. Data for calculating injection force stored on the cassette's identification element and translated by the RFID radar may include, for example, length of the needle, needle gauge, diameter of the syringe barrel and concentration of the dose.” [0036]);
a display device (user interface 152) configured to output information regarding an injection operation (“the control system 150 can be based on feedback from one or more sensors (described further below), or from input received from a user via a user interface 152 (e.g., touch screen, buttons). For example, the injector 100 can include an RFID reader 154 for wirelessly reading the identification information on the RFID tag 238 on the cassette 230 (FIG. 4A). In one embodiment, the user interface 152 can be simple with higher-function control available remotely through a mobile and/or web application.” [0029]); and
a control device (control system 150) configured to control the motor driver, the memory and the display device (see all of [0030]), wherein:
with the drug cartridge loaded in the housing space, the control device cause the device to receive drug information including information indicating a type of drug in the drug cartridge transmitted from the RF tag of the drug cartridge (“the control system 150 can be based on feedback from one or more sensors (described further below), or from input received from a user via a user interface 152 (e.g., touch screen, buttons). For example, the injector 100 can include an RFID reader 154 for wirelessly reading the identification information on the RFID tag 238 on the cassette 230 (FIG. 4A).” [0029]; “the cassette 230 can also include identification information, such as lot number and/or dimensions of the hypodermic syringe 210, lot number of the cassette 230, drug batch and/or expiry date, etc. In one embodiment, the identification information can be stored on an RFID tag 238” [0025]) and first temperature information detected by the first temperature sensor (“the thermal sensor 160 can transmit data related to the temperature of the liquid medicament 202 to the control system 150 via a thermoresistor circuit 16” [0030]); and determine a drive power of the motor based on the first temperature information to control the motor driver so as to output the determined drive power (“the control system 150 includes memory for storing data related to doses received, injections performed, user-generated injection parameter, etc. For example, the memory can store programs specific for a medicament's rheology. The control system 150 can use input from sensors, such as the thermal sensor 160, in combination with the stored rheology programs in order to calculate a medicament's viscosity. The memory also stores programs for operating the injector 100, such as injection force calculation and corresponding motor speed.” [0030]; see all of [0030]; “the motor speed can be actively controlled by the control system” [0035], see also Figure 11), wherein:
the RF tag (RFID tag 238) stores drug information including information indicating at least a type of the drug (“the cassette 230 can also include identification information, such as lot number and/or dimensions of the hypodermic syringe 210, lot number of the cassette 230, drug batch and/or expiry date, etc. In one embodiment, the identification information can be stored on an RFID tag 238” [0025]);
with the drug cartridge loaded in the housing space, the control device is configured to:
receive first temperature information and drug information output from the first temperature sensor and the RF tag of the drug cartridge (“the control system 150 can be based on feedback from one or more sensors (described further below), or from input received from a user via a user interface 152 (e.g., touch screen, buttons). For example, the injector 100 can include an RFID reader 154 for wirelessly reading the identification information on the RFID tag 238 on the cassette 230 (FIG. 4A).” [0029]; “the thermal sensor 160 can transmit data related to the temperature of the liquid medicament 202 to the control system 150 via a thermoresistor circuit 16” [0030]);
determine one set of control parameters from the control information stored in the memory based on the first temperature information and the drug information (“the control system 150 includes memory for storing data related to doses received, injections performed, user-generated injection parameter, etc. For example, the memory can store programs specific for a medicament's rheology. The control system 150 can use input from sensors, such as the thermal sensor 160, in combination with the stored rheology programs in order to calculate a medicament's viscosity. The memory also stores programs for operating the injector 100, such as injection force calculation and corresponding motor speed.” [0030]; see also Figure 11); and
control the motor using the determined set of control parameters (“the motor speed can be actively controlled by the control system” [0035], see all of [0030]); and
wherein when the first temperature information is in a second temperature range that is equal to or greater than a first temperature (temperature of “refrigerated storage” [0033]) and less than a third temperature (“threshold temperature” [0033]), the control device controls the display device to display information indicating to wait before injection (“a user can remove a dose module containing a dose of the liquid medicament out of refrigerated storage (if necessary) in order to raise a temperature of the medicament to room temperature, for example…The method 600 can continue with sending a second notification reminder to the user when the temperature of the medicament reaches a threshold temperature (e.g., reaches desired injection temperature) (block 604).” [0033], wherein the display device indicates to wait until the second notification reminder),
the drug injection device according to claim 15, further comprising a second temperature sensor (skin sensor 162; “A skin sensor 162 (e.g.,…temperature sensor” [0030]) provided in the device housing (Figure 5).
Dahmani fails to explicitly disclose an antenna arranged adjacent to the housing space; a transmission/reception circuit configured to transmit electromagnetic waves from the antenna and receive electromagnetic waves received by the antenna; the control device configured to control the transmission/reception circuit; the control device causes the transmission/reception circuit to receive, via the antenna, the drug information and first temperature information; the control device configured to cause the transmission/reception circuit to transmit a control signal via the antenna; cause the transmission/reception circuit to receive, via the antenna, first temperature information and drug information output from the first temperature sensor and the RF tag of the drug cartridge; wherein the control device does not drive the motor when the first temperature information is in a first temperature range that is less than a first temperature or equal to or greater than a second temperature, and the third temperature is lower than the second temperature, the second temperature sensor is configured to output second temperature information indicating a temperature inside the device housing, wherein when the second temperature information is equal to or greater than a predetermined temperature, the control device successively obtains the first temperature information at predetermined time intervals, successively calculates estimated time until it is possible to perform injection based on the first temperature information and the second temperature information, and controls the display device to display information indicating the calculated estimated time; when the first temperature information is in a second temperature range that is equal to or greater than the first temperature and less than the third temperature lower than the second temperature, the control device controls the display device to display information that allows a user to select whether or not he/she wants to wait for injection, and when the second temperature information is lower than the predetermined temperature, the control device controls the display device to display information indicating that it is impossible to perform injection, without calculating estimated time.
Tachibana teaches a drug injection device (syringe pump 1) comprising a device housing (body of syringe pump 1) housing a drug cartridge (syringe 2) having an RF tag (identification tag 3; [0067]); a piston (slider assembly 50) driven by a motor (motor 119), a motor driver (motor driving circuit 118) configured to generate a drive signal for driving the motor (“a motor driving circuit 118 for driving a motor 119 which drives the slider assembly 50,” [0071]); an antenna (loop antenna 46) arranged adjacent to the housing space (Figure 9); and a transmission/reception circuit (radio frequency circuit 40 of reading and rewriting portion 65) configured to transmit electromagnetic waves from the antenna and receive electromagnetic waves received by the antenna (“The reading and rewriting portion 65 has the radio frequency circuit 40 built therein, and reads and rewrites the identification tag 3 by exchanging control signals sent from a signal control portion 66.” [0069]); and a control device (control circuit 104 and CPU 100) configured to control the transmission/reception circuit (“The control circuit 104 is connected to the loop antenna 46 connected to the reading and rewriting portion 65. The loop antenna 46 is placed opposite the loop antenna 45 of the identification tag 3 in the state of having the syringe 2 loaded as an example of the drug infusion device so as to read and rewrite the identification tag 3 by exchanging the control signals sent from the control circuit 104.” [0070]); the control device configured to cause the transmission/reception circuit to receive, via the antenna, drug information transmitted from an RF tag of the drug cartridge (“The control circuit 104 is connected to the loop antenna 46 connected to the reading and rewriting portion 65. The loop antenna 46 is placed opposite the loop antenna 45 of the identification tag 3 in the state of having the syringe 2 loaded as an example of the drug infusion device so as to read and rewrite the identification tag 3 by exchanging the control signals sent from the control circuit 104.” [0070]; “the identification tag 3 is automatically read in a step S14, and reading results are displayed on the data input apparatus.” [0074]); and the control device (control circuit 104 and CPU 100) configured to cause the transmission/reception circuit to transmit a control signal via the antenna and cause the transmission/reception circuit to receive, via the antenna, drug information output from the RF tag of the drug cartridge (“The control circuit 104 is connected to the loop antenna 46 connected to the reading and rewriting portion 65. The loop antenna 46 is placed opposite the loop antenna 45 of the identification tag 3 in the state of having the syringe 2 loaded as an example of the drug infusion device so as to read and rewrite the identification tag 3 by exchanging the control signals sent from the control circuit 104.” [0070]; “the identification tag 3 is automatically read in a step S14, and reading results are displayed on the data input apparatus. Consequently, the specific health worker such as the doctor refers to a drug record of the patient to whom the liquid infusing is performed in a step S15, and determines the data such as the liquid infusing time or the liquid infusing flow rate of the drug according to symptoms of the patient and so on, and inputs them together with the data on the patient and health workers (one's doctor, nurse, pharmacist and so on) by using a keyboard of the data input apparatus 200 and so on in a step S16.” [0074]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include an antenna and a transmission/reception circuit controlled by the control device and the control device configured to cause the transmission/reception circuit to receive, via the antenna, the drug information and first temperature information and the control device configured to cause the transmission/reception circuit to transmit a control signal via the antenna; cause the transmission/reception circuit to receive, via the antenna, first temperature information and drug information output from the first temperature sensor and the RF tag of the drug cartridge based on the teachings of Tachibana to allow the control device to both receive drug information from the drug cartridge in order to effectively operate the drug injection device and also allow for the control device to transmit new information to the RF tag of the drug cartridge in order to update the drug information for a specific patient (Tachibana [0003-0009]).
Modified Dahmani fails to explicitly disclose wherein the control device does not drive the motor when the first temperature information is in a first temperature range that is less than a first temperature or equal to or greater than a second temperature, and the third temperature is lower than the second temperature; and the second temperature sensor is configured to output second temperature information indicating a temperature inside the device housing, wherein when the second temperature information is equal to or greater than a predetermined temperature, the control device successively obtains the first temperature information at predetermined time intervals, successively calculates estimated time until it is possible to perform injection based on the first temperature information and the second temperature information, and controls the display device to display information indicating the calculated estimated time, when the first temperature information is in a second temperature range that is equal to or greater than the first temperature and less than the third temperature lower than the second temperature, the control device controls the display device to display information that allows a user to select whether or not he/she wants to wait for injection, and when the second temperature information is lower than the predetermined temperature, the control device controls the display device to display information indicating that it is impossible to perform injection, without calculating estimated time.
Hanada teaches a drug injection device (injection device 9) comprising a device housing (holding unit 9a), a drug cartridge (holder 1 with syringe 2), a temperature sensor (temperature sensor 12), and a control device (control unit 10); wherein the control device does not drive a motor (motor 14) of the drug injection device (“It can also be prevented by making the injection device unusable by blocking the movement of the piston rod or by blocking the power supply to the motor.” [Page 10]) when a first temperature information is in a first temperature range that is less than a first temperature (“a warning can be immediately issued when a low temperature below a certain temperature is detected in order to prevent injection of the frozen peptide. Such a temperature is suitably in the range of 0 to -20 ° C., for example, 0 ° C., −2 ° C., −4 ° C., −10 ° C., −20 ° C., etc., depending on the type of peptide, dosage form, etc.” [Page 7]) or equal to or greater than a second temperature (“when an extremely high temperature is detected, a setting can be made to immediately issue a warning. Since peptide preparations may be rapidly denatured when exposed to a certain high temperature or higher, setting such a temperature is effective in preventing injection of denatured peptide preparations. For example, if an injection device is left unintentionally in a car that is exposed to direct sunlight in summer, the drug may become extremely hot (for example, 70 ° C.) and the components of the drug may be denatured. Such temperature is in the range of 40 to 80 ° C., for example, 40, 50, 60, 70, 80 ° C., etc., depending on the type of peptide when the drug in the syringe held in the injection device is a peptide preparation. Set to an appropriate value. In this case, the misuse prevention unit can immediately issue a warning without measuring the time with a timer, and when the temperature is detected by setting the set time length to, for example, 0.01 to 1 second. , It can also be set to issue a warning substantially immediately.” [Page 7]); and wherein a first temperature information is compared to a first temperature (“a warning can be immediately issued when a low temperature below a certain temperature is detected in order to prevent injection of the frozen peptide. Such a temperature is suitably in the range of 0 to -20 ° C.,” [Page 7]), a second temperature (“when an extremely high temperature is detected, a setting can be made to immediately issue a warning…Such temperature is in the range of 40 to 80 ° C.” [Page 7]), and a third temperature that is lower than the second temperature (“When the drug in the syringe held in the injection device is a peptide preparation, the set temperature range is generally preferably 1 to 15 ° C., more preferably 2 to 8 ° C. However, when the peptide preparation is used outdoors, the set temperature is 1 to 30 ° C., 2 to 30 ° C., 1 to 35 ° C. according to the storage temperature individually permitted in such preparation. , 2 to 35 ° C., etc.” [Page 6-7]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include the control device does not drive the motor when the first temperature information is in a first temperature range that is less than a first temperature or equal to or greater than a second temperature and the third temperature is lower than the second temperature based on the teachings of Hanada ensure that the drug is safe for injection and has not been damaged due to extreme high or low temperatures (Hanada [Page 7, Page 17]).
Modified Dahmani fails to explicitly disclose the second temperature sensor is configured to output second temperature information indicating a temperature inside the device housing, wherein when the second temperature information is equal to or greater than a predetermined temperature, the control device successively obtains the first temperature information at predetermined time intervals, successively calculates estimated time until it is possible to perform injection based on the first temperature information and the second temperature information, and controls the display device to display information indicating the calculated estimated time, when the first temperature information is in a second temperature range that is equal to or greater than the first temperature and less than the third temperature lower than the second temperature, the control device controls the display device to display information that allows a user to select whether or not he/she wants to wait for injection, and when the second temperature information is lower than the predetermined temperature, the control device controls the display device to display information indicating that it is impossible to perform injection, without calculating estimated time.
Davis teaches a drug injection device (injector 101) comprising a device housing (Figure 1) housing a drug cartridge (syringe 104), a first temperature sensor (temperature sensor 107), and a second temperature sensor (“a second temperature sensor (not shown) may be used to measure the ambient temperature of the surroundings.” [0037]) configured to output second temperature information indicating a temperature inside the device housing (“detecting an ambient temperature using a second temperature sensor; and setting the preset temperature as the ambient temperature.” [0013]), wherein when the second temperature information (“ambient temperature” [0037]) is equal to or greater than a predetermined temperature, the control device successively obtains a first temperature information from the first temperature sensor at predetermined time intervals, successively calculates estimated time until it is possible to perform injection based on the first temperature information and the second temperature information (“FIG. 3 depicts a flow diagram illustrating a method by which the injector with a ready-to-use indicator may be used, in accordance with various aspects of the present disclosure. The injector may be removed from cold storage 301. Next, the temperature sensor may be activated through the use of an initiator tied to a controller and may begin measuring the medicament temperature (and, in some cases, the ambient temperature) 302. Next, 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.” [0034]; “a second temperature sensor (not shown) may be used to measure the ambient temperature of the surroundings. The controller may optionally use the ambient temperature to help determine a temperature at which the medicament is to be dispensed.” [0037]), and controls a display device (display 1101) to display information indicating the calculated estimated time (“an injector with ready-to-use indicator may be a component for injection devices with refrigerated storage that may provide visual and/or audio indications to device users when a desired warm up time has been reached and the internal temperature of the device, and more specifically the injectable drug (medicament) which is to be administered, has reached an acceptable temperature for injection.” [0026]; Figure 11; [0039]), and when the second temperature information is lower than the predetermined temperature, the control device controls the display device to display information indicating that it is impossible to perform injection, without calculating estimated time (“FIGS. 10 and 11 illustrate various examples of the audio and/or visual indicator used in the ready-to-use-indicator. At either the pre-programmed time or after reaching a pre-set temperature, one or more of LEDs 1001, display 1101, speaker, and vibration motor may be activated to indicate to the user that the device is ready to use… solid red may indicate “do not use, device is not ready”.” [0039]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include the second temperature sensor is configured to output second temperature information indicating a temperature inside the device housing wherein when the second temperature information is equal to or greater than a predetermined temperature, the control device successively obtains the first temperature information at predetermined time intervals, successively calculates estimated time until it is possible to perform injection based on the first temperature information and the second temperature information, and controls the display device to display information indicating the calculated estimated time, and when the second temperature information is lower than the predetermined temperature, the control device controls the display device to display information indicating that it is impossible to perform injection, without calculating estimated time based on the teachings of Davis to ensure that the drug has reached its target temperature after being removed from cold storage and is thermally ready for injection (Davis [0011], [0033-0034]).
Modified Dahmani fails to explicitly disclose when the first temperature information is in a second temperature range that is equal to or greater than the first temperature and less than the third temperature lower than the second temperature, the control device controls the display device to display information that allows a user to select whether or not he/she wants to wait for injection.
Marlin teaches a drug injection device (automatic injector 50) comprising a drug cartridge (cartridge 54) and a temperature sensor (drug temperature sensor 660) for sensing first temperature information (“drug temperature sensor 660 may be positioned to be in close proximity to the drug and/or the drug container 54, and configured to detect temperatures of the drug.” [0082]), wherein when the when the first temperature information is in a temperature range that is less than a target temperature, a control device (control unit 605) controls a display device (display unit 635) to display information that allows a user to select whether or not he/she wants to wait for injection (“The control unit 605 of the auto injector 50 may be configured such that one or more operations of the automatic injector are disabled if one of the temperature sensors (e.g., the drug temperature sensor-B 660) detects that the temperature of the drug is not within the specified operational temperature range, and/or the heater temperature sensor 655 detects that the temperature of the heater 650 is at or above, or below an alarm point temperature…Automatic injector 50 may further provide an override mechanism which allows the user to activate automatic injector 50 when sensor 660 detects that the drug or drug container is not within the operational temperature range of the drug.” [0092-0093], see [0094]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the drug injection device of Dahmani to include that when the first temperature information is in a second temperature range that is equal to or greater than the first temperature and less than the third temperature lower than the second temperature, the control device controls the display device to display information that allows a user to select whether or not he/she wants to wait for injection based on the teachings of Marlin to allow for immediate delivery of the drug in an acute situation (Marlin [0093]).
Regarding claim 16, modified Dahmani discloses the drug injection device according to claim 8, wherein when the first temperature information is in a third temperature range that is equal to or greater than the third temperature (“threshold temperature” [0033]), the control device controls the display device to display information indicating that it is possible to perform injection (“The method 600 can continue with sending a second notification reminder to the user when the temperature of the medicament reaches a threshold temperature (e.g., reaches desired injection temperature) (block 604). The method 600 continues with setting an injection speed of the injector (block 606).” [0033]).
Modified Dahmani fails to explicitly disclose the third temperature range is equal to or greater than the third temperature and less than the second temperature.
Hanada teaches a drug injection device (injection device 9) comprising a device housing (holding unit 9a), a drug cartridge (holder 1 with syringe 2), a temperature sensor (temperature sensor 12), and a control device (control unit 10); wherein a first temperature information is compared to a first temperature (“a warning can be immediately issued when a low temperature below a certain temperature is detected in order to prevent injection of the frozen peptide. Such a temperature is suitably in the range of 0 to -20 ° C.,” [Page 7]), a second temperature (“when an extremely high temperature is detected, a setting can be made to immediately issue a warning…Such temperature is in the range of 40 to 80 ° C.” [Page 7]), and a third temperature t (“When the drug in the syringe held in the injection device is a peptide preparation, the set temperature range is generally preferably 1 to 15 ° C., more preferably 2 to 8 ° C. However, when the peptide preparation is used outdoors, the set temperature is 1 to 30 ° C., 2 to 30 ° C., 1 to 35 ° C. according to the storage temperature individually permitted in such preparation. , 2 to 35 ° C., etc.” [Page 6-7]), wherein when a first temperature information is in a third temperature range that is equal to or greater than the third temperature and less than the second temperature performing an injection is possible (“When the drug in the syringe held in the injection device is a peptide preparation, the set temperature range is generally preferably 1 to 15 ° C., more preferably 2 to 8 ° C. However, when the peptide preparation is used outdoors, the set temperature is 1 to 30 ° C., 2 to 30 ° C., 1 to 35 ° C. according to the storage temperature individually permitted in such preparation., 2 to 35 ° C., etc.” [Page 6-7]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include the third temperature range is equal to or greater than the third temperature and less than the second temperature based on the teachings of Hanada ensure that the drug is safe for injection and has not been damaged due to extreme high or low temperatures (Hanada [Page 7, Page 17]).
Regarding claim 38, modified Dahmani discloses the drug injection device according to claim 8.
Modified Dahmani fails to explicitly disclose wherein when the first temperature information reaches the third temperature, the control device controls the display device to display information indicating that appropriate temperature has been reached.
Davis teaches a drug injection device (injector 101) comprising a device housing (Figure 1) housing a drug cartridge (syringe 104), a first temperature sensor (temperature sensor 107) for detecting first temperature information (“the temperature sensor 107 may continuously monitor the temperature of the medicament” [0033]), wherein when the first temperature information reaches a target temperature, a control device (controller 105) controls a display device (LCD screen 1101) to display information indicating that appropriate temperature has been reached (“At either the pre-programmed time or after reaching a pre-set temperature, one or more of LEDs 1001, display 1101, speaker, and vibration motor may be activated to indicate to the user that the device is ready to use…In examples using an LCD screen 1101, either numerical, verbal, or graphical indication(s) may be shown to let the user know when they may use the device.” [0039]; Figures 10-11).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include that when the first temperature information reaches the third temperature, the control device controls the display device to display information indicating that appropriate temperature has been reached based on the teachings of Davis to alert the user that the drug has reached its target temperature after being removed from cold storage and is thermally ready for injection (Davis [0011], [0033-0034], [0039]).
Claims 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Dahmani et al. (US 20200297933) in view of Tachibana (US 20050029277) in further in view of Hanada (WO 2013073650), further in view of Davis et al. (US 20200030544), and in further view of Marlin et al. (US 20180236181) as applied in claim 8 above, and further in view of Albertini et al. (US 20220323695).
Regarding claim 36, modified Dahmani discloses the drug injection device according to claim 8.
Modified Dahmani fails to explicitly disclose when the difference between consecutive pre- and post-temperatures successively obtained by the first temperature sensor is less than or equal to a predetermined temperature difference, the control device calculates estimated time until it is possible to perform injection.
Albertini discloses a drug injection device (autoinjector 100) comprising a drug cartridge (drug holder 110) and a temperature sensor (“The sensor can be configured to detect at least one exposure condition, such as an environmental condition, of the drug… the at least one exposure condition may indicate that a temperature of the drug” [0151]), wherein when a difference between consecutive pre- and post-temperatures successively obtained by the first temperature sensor is less than or equal to a predetermined temperature difference, the control device calculates estimated time until it is possible to perform injection (“The sensed data can be transmitted, e.g., through a communications interface, to a processor that is configured to analyze and determine the effect of the at least one exposure condition on the drug and/or how long the patient should wait before room temperature may bring the drug to a more comfortable temperature given the sensed current temperature. The sensed data can be transmitted to the processor at a regular sampling rate, on demand, or continuously.” [0151], wherein the predetermined temperature difference is any difference between regularly sampled temperatures).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include the difference between consecutive pre- and post-temperatures successively obtained by the first temperature sensor is less than or equal to a predetermined temperature difference, the control device calculates estimated time until it is possible to perform injection based on the teachings of Albertini ensure that the drug has reached a comfortable temperature prior to beginning an injection (Albertini [0151]).
Regarding claim 37, modified Dahmani discloses the drug injection device according to claim 8.
Modified Dahmani fails to explicitly disclose the control device transmits the calculated estimated time to a portable device and controls the portable device to display the calculated estimated time.
Albertini discloses a drug injection device (autoinjector 100) comprising a drug cartridge (drug holder 110) and a temperature sensor (“The sensor can be configured to detect at least one exposure condition, such as an environmental condition, of the drug… the at least one exposure condition may indicate that a temperature of the drug” [0151]), wherein a control device is configured to calculate an estimated time to wait (“The sensed data can be transmitted, e.g., through a communications interface, to a processor that is configured to analyze and determine the effect of the at least one exposure condition on the drug and/or how long the patient should wait before room temperature may bring the drug to a more comfortable temperature given the sensed current temperature. The sensed data can be transmitted to the processor at a regular sampling rate, on demand, or continuously.” [0151]), the control device transmits the calculated estimated time to a portable device (reader 1700) and controls the portable device to display the calculated estimated time (“the reader 1700 is configured to show information 1702 regarding the scanned data on a display screen 1704 of the reader 1700. The information 1702 regarding the scanned data in this illustrated embodiment includes…miscellaneous information…The miscellaneous information can include…a message indicating that the patient should wait an amount of time before room temperature may bring the drug to a more comfortable temperature for drug delivery given the sensed current temperature” [0185]; see all of [0185]; Figures 16-17).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the drug injection device of Dahmani to include the control device transmits the calculated estimated time to a portable device and controls the portable device to display the calculated estimated time based on the teachings of Albertini ensure that the drug has reached a comfortable temperature prior to beginning an injection and to communicate that information to the user (Albertini [0151], [0185]).
Response to Arguments
Applicant’s arguments with respect to claims 8, 16, and 36-38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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