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 on 07/27/26 has been entered in the case. Claims 1-4,8-11,15 and 21-22 are pending for examination, claims 16, 20, 23 & 23 are withdrawn and claims 5-7, 12-14, 17-19 are cancelled.
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: para [0024] states that: a user activates a finger sensor 160b, for example, by pressing, pushing, and/or covering the finger sensor 160b. The finger sensor 160b may include a button, a capacitive touch sensor, a light sensor, or any other suitable sensor that may detect a touch or close proximity of a finger, a palm, or another suitable object... Additionally or alternatively, meeting the conditions for delivering the injection may include detecting, using a skin sensor 160d, that the drug delivery device 102 is in contact with skin. The skin sensor may include a capacitance sensor, a resistance sensor, an inductance sensor, a pressure sensor, a light sensor, and/or any other suitable sensor configured to detect that the drug delivery device 102 is in contact with skin at an injection site.
Based on the statement in para [0024] above, the finger sensor 160b/160d is/are equivalent to a force/strain sensor. When a force/strain sensor is pressed by a user’s finger, a mechanical force is applied to the button 160b or skin sensor 160d presses on the skin surface. At that time, the force induces a physical change within the sensor, which may entail bending or stretching or compressing its internal components inside the drug delivery device 102. As a result of the physical alternation, the internal properties of the sensor such as resistance or capacitance (mentioned in the para [0024] above) undergo modification. This change is then converted into an electrical signal. 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. 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;
Therefore, a person skilled in the art would recognize that the finger/skin sensor 160b/160d can be equivalent or used as a strain sensor or tensile or compressible strain sensor (as evidence or modified by Zwerg as below).
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]. As mentioned above, the sensor 160b/160d is equivalent or can be modified to use as a strain sensor to detect the motion change.
Zwerg discloses that a piezoelectric sensing element is referred to as a “capacitive element” (capacitor) because of its capacitive behavior when coupled to an electric circuit (col. 3, lines 5-8). Zwerg further discloses that piezoelectric sensors operating in the piezoelectric sensing mode can detect a change in strain, pressure, stress, or force (col. 5, lines 32-37). The piezo device including a strain sensor can 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 a lack of a change in motion (see col. 2, lines 30-60). Based on the statements above, a person skilled in the art would recognize that the capacitive element (or capacitive sensor or strain sensor) can detect a motion change or detect in strain, stress.
The substitution of one known element - the strain sensor taught in Zwerg for detecting motion to wake up a circuit or change from a low-energy to an active state - for another element, such as the finger or skin sensor in Paramanandam, would have been obvious to one of ordinary skill in the art prior to the effective filing date. Substituting the strain sensor of Zwerg into Paramanandam would have yielded predictable results, such as detecting a motion change when a user presses a button or places the device against their skin to activate the circuit.
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 filed 07/27/26 have been fully considered but they are not persuasive.
1) Applicant argues that Zwerg’s piezoelectric strain sensor is a generic motion detector, not a packaging removal or body attachment strain detector.
In response, Paramanandam discloses in the para [0024] states that: a user activates a finger sensor 160b, for example, by pressing, pushing, and/or covering the finger sensor 160b. The finger sensor 160b may include a button, a capacitive touch sensor, ... or any other suitable sensor that may detect a touch or close proximity of a finger, a palm, or another suitable object... The skin sensor 160d may include a capacitance sensor, a resistance sensor, an inductance sensor, a pressure sensor, a light sensor, and/or any other suitable sensor configured to detect that the drug delivery device 102 is in contact with skin at an injection site.
It is noted that when a force/strain sensor is pressed by a user’s finger, a mechanical force is applied to the button 160b or skin sensor 160d presses on the skin surface. At that time, the force induces a physical change within the sensor, which may entail bending or stretching or compressing its internal components inside the drug delivery device 102. As a result of the physical alternation, the internal properties of the sensor such as resistance or capacitance (mentioned in the para [0024] above) undergo modification. This change is then converted into an electrical signal. 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. 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;
Therefore, a person skilled in the art would recognize that the finger/skin sensor 160b/160d can be equivalent or used as a strain sensor or tensile or compressible strain sensor (as evidence or modified by Zwerg as below).
Meanwhile, Zwerg discloses that using a capacitive sensor (or a piezoelectric strain sensor) provides a generic motion detector. It is noted that the action of pressing the button 160b or pressing the skin sensor 160d detects a change in motion (e.g., pressing or compressive strain). Therefore, a person skilled in the art would recognize that the piezoelectric strain sensor of Zwerg can be used to replace the button sensor or skin sensor in Paramanandam to achieve the same purpose of detecting the pushing strain or compressive strain on the button 160b or on the skin sensor 160d.
2) Applicant argues that Zwerg has no connection to the drug delivery device context or to the application-specific triggering events recited in the claims. Zwerg contains no disclosure of a drug delivery device, a patient, a package, a packaging-removal event, a body-attachment event or any application specific physical trigger.
In response, as mentioned in the part 1) of Response to Argument above, Zwerg discloses that sing a capacitive sensor (or a piezoelectric strain sensor) provides a generic motion detector. It is noted that the action of pressing the button 160b or pressing the skin sensor 160d (in Paramanandam) detects a change in motion (e.g., pressing or compressive strain). Therefore, a person skilled in the art would recognize that the piezoelectric strain sensor of Zwerg can be used to replace the button sensor or skin sensor in Paramanandam to achieve the same purpose of detecting the pushing strain or compressive strain on the button 160b or on the skin sensor 160d.
Conclusion
THIS ACTION IS MADE FINAL. 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 QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
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