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 .
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 1-3, 8-11, 15, 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Paramanandam et al. (US 2022/0347398) in view of Zwerg et al. (US 11,105,676).
Regarding claim 1, Paramanandam discloses a drug delivery device 110, comprising:
a pump mechanism, i.e. drive unit 142 & 126 coupled to a reservoir 150 for expelling a liquid drug from the reservoir; and
an activation component 160b (or 160d) communicatively (via a communication bus 128) coupled to the pump mechanism, the activation component 1040, comprising:
a sensor 160b/160d coupled to the drug delivery device 110 and operable to detect a change as the drug delivery device is attached to a user (when the user presses button 160b or when the drug deliver device 110 in contact to the skin of the user via skin sensor 160d). Note: the sensor 160b is a finger sensor that detects a touch of close proximity of a finger, palm, or another suitable object. The sensor 160d is a skin sensor that detects the drug delivery device 102 in contact with skin. Therefore, the sensor 160b/160d can be detect a compressive strain in certain degrees when the user presses the button 160b or when the skin sensor 160 of the device 102 being pressed down and contact with the skin;
a wake-up circuit operable to: receive an input from the sensor (when the user presses button 160b or when the drug delivery device 110 in contact to the skin of the user via skin sensor 160d); and based on the input from the sensor, transition the drug delivery device from a low-energy (in lower-power mode) to an active state, paras [0021, 0024].
Paramanandam discloses that the sensor 160b/160d is a capacitive touch sensor, resistance sensor, a pressure sensor, or any other suitable sensor that may detect a touch or close proximity of a finger, palm, or another suitable object, para [0024] but does not state that the sensor(s) above is a strain sensor.
Zwerg discloses a piezo device includes a strain sensor can: 1) select a “wake” or a “sleep” operating mode for a microcontroller unit (MCU) in response to a respective detected change in motion or a determination of lack of a change in motion, see col. 2, lines 30-60.
The substitution of one known element (strain sensor is used for detecting a motion to wake-up a circuit, or to change a status from low-energy state to an active state as taught in Zwerg) for another (finger sensor or skin sensor as shown in Paramanandam would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention since the substitution of the strain sensor shown in Zwerg would have yielded predictable results, such as detecting a motion change when pressing a button or when the device in contact a skin of user in Paramanandam to wake-up a circuit, or to change a status from low-energy state to an active state.
Regarding claim 2, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam in view of Zwerg discloses the drug delivery device comprising a power supply 144 communicatively coupled to the wake-up circuit 116a & 128; wherein the wake-up circuit is further operable to transition the drug delivery device from the low-energy state to the active state by activating the power supply.
Regarding claim 3, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam in view of Zwerg discloses the drug delivery device further comprising a controller 120 communicatively coupled to the power supply 114, wherein activation of the power supply (via button 160b) causes activation of the controller.
Regarding claim 8, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam further discloses that the activation component comprises a location device (a wireless communication module 130/180), and wherein the wake-up circuit is further operable to transition the drug delivery device from the low-energy state to the active state in response to a detected proximity of the location device to a predetermined location or to a predetermined object (a mobile 104 is located nearby the drug delivery device to pair in between these two devices). In addition, Paramanandam discloses that the sensors 160a-d and/or additional sensors, that the drug delivery device 102 is in correct orientation with respect to the user and/or to gravitational field. In order to detect the correct orientation, therefore, the drug delivery device includes a sensor or location device to detect the correct orientation.
Note: a wireless communication module is generally considered as a location device. Its primary role is to transfer date, it can determine a device’s physical position when paired in between the devices through the network.
Regarding claim 10, it encompasses the same scope of the invention as to that of claim 1 except they are drafted in method format instead of apparatus format. The claim is therefore rejected for the same reason as set forth above.
Regarding claim 11, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam further discloses that wherein transitioning the drug delivery device from the low-energy state to the active state comprises: activating a power supply 114 of the drug delivery device; and activating a controller 120 of the drug delivery device in response to the activation of the power supply, para [0021] see Figs 1-3.
Regarding claim 15, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam further discloses that further comprising causing the drug delivery device to transition from the low-energy state to the active state (the power supply 114 wakes-up the drug delivery device by itself when the circuit is being closed loop) without communication between the drug delivery device and an external interface device.
Regarding claim 21, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam discloses that the wake-up circuit in the drug delivery device operates by itself at locally without connecting to a remote control device.
Regarding claim 22, Paramanandam in view of Zwerg discloses all the claimed subject matter as required. Paramanandam discloses that wherein the pump mechanism 140 & 142 is configured to provide only a basal delivery of the liquid drug.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Paramanandam et al. (US 2022/0347398) in view of Zwerg et al. (US 11,105,676) and further in view of Arnold et al. (US 2013/0245545).
Paramanandam in view of Zwerg discloses all the claimed subject matter as required except for the limitation that a blood glucose sensor communicatively coupled to the drug delivery device.
Arnold discloses a system in Figs. 1-3, 11A-G, comprising: a blood glucose sensor 311/1121/1141 communicatively coupled to a drug delivery device 100/1110/1141, in Figs. 3, 11A, 11D.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Paramanandam in view of Zwerg with including an analyte monitoring port for receiving a blood glucose sensor, as taught by Arnold, in order to monitor blood glucose values from a patient.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Paramanandam et al. (US 2022/0347398) in view of Zwerg et al. (US 11,105,676) and further in view of McCullough et al. (US 2017/01119969.
In case Applicant disagrees with the rejection in claim 8 above, the claim 8 is alternatively rejected as follow:
Paramanandam in view of Zwerg discloses all the claimed subject matter. Assuming that as Paramanandam in view of Zwerg does not include the activation component further comprises a location device, and wherein the wake-up circuit is further operable to transition the drug delivery device from the low-energy state to the active state in response to a detected proximity of the location device to a predetermined location or to a predetermined object.
McCullough further discloses that wherein the activation component further comprises a location device (Geographic position, GPS, para [0156]; or orientation sensors 1064, in paras [0184-0186], and wherein the wake-up circuit is operable to transition the drug delivery device from the low-energy state to the active state in response to a detected proximity of the location device to a predetermined location or to a predetermined object.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Paramanandam in view of Zwerg with including a location device, as taught by McCullough, in order to detect a position or location of the drug delivery device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4, 8-11, 15, 21-22 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.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783