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
Applicant’s amendments, filed 05/07/2026, has been entered. Claims 1-20 remain pending.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring et al. (US20150290390), hereafter Ring, in view of Finan et al. (US20180296757), hereafter Finan.
Regarding Claim 1, Ring discloses a wearable drug delivery device (Ring, Fig. 17, a wearable drug delivery device) comprising: a controller configured to output control signals (par. 0049, controller 56) (Examiner Notes: a controller under ordinary meaning would output control signals to operate); a memory coupled to the controller and configured to store programming code (par. 0029, “The controller 56 may also include a microprocessor”) (Examiner Notes: A memory storing programming codes is inherently included by a microprocessor).
Ring is silent on a site maintenance application, wherein the programming code and the site maintenance application are executable by the controller.
However, Finan teaches a wearable drug delivery device (Fig. 1, drug delivery device 102), comprising of a controller (par. 0020, a controller 104), a memory configured to store programming code (par. 0025, “memory elements for storing control programs and operation data”), and a site maintenance application, wherein the programming code and the site maintenance application are executable by the controller (par. 0027, “The controller 104 is a smartphone running an application (downloadable software application) that communicates with the drug delivery device 102 via the link 111 to provide functions for remote operation of the drug delivery device 102 and remote monitoring of blood glucose”). Finan further teaches a infusion device (Fig. 1 infusion set 106) for injecting insulin.
Furthermore, the “site maintenance application” claimed by the applicant is essentially having a controller operating a vibrational actuator to generate vibration. Ring already discloses a controller and a vibration generator; therefore, Ring is capable of performing the same function as the claimed “site maintenance application”.
Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known drug delivery device of Ring, with the site maintenance application of Finan, for bolus and insulin control based on feedbacks as taught by Finan (Finan, par. 0020).
The modified Ring further discloses a vibrational actuator coupled to the controller and configured to generate vibrations in response to a control signal from the controller (Ring, par. 0049, “vibration generator 62 may be controlled by the controller 56 to which it is operatively coupled”); a reservoir configured to store a therapeutic drug (Ring, par. 0061, “the reservoir 52 may be filled with a drug or pharmaceutical product”); and at least one housing configured to contain the controller, the memory, the vibrational actuator, and the reservoir (Ring, par. 0055, “a wearable drug delivery device has a housing 200”) (Examiner Notes: the prior art does not specifically disclose the housing contains all the claimed element, however, under ordinary definition, a housing is a casing that enclose all the elements inside), and wherein an adhesive layer disposed on a bottom surface of the at least one housing which is configured to affix to skin of a user (Ring, par. 0057, “the adhesive layer 202 disposed about the region 206 attaches the device (and in particular, the housing 200) to the skin surface 212”), and wherein the controller when executing the site maintenance application is configured to: obtain blood glucose data (Finan, par. 0020, “The controller 104 can be configured to include a closed-loop controller that has been programmed to receive continuous glucose readings from a CGM sensor 112 via a communications link 110”); and based on the blood glucose data control the vibrational actuator (Finan, par. 0020 discloses delivering insulin based on blood glucose data, after the modification, the vibration actuator will activated to deliver insulin based on blood glucose) to generate vibrations that extend below the bottom surface (Ring, par. 0049, “Actuation of the vibration generator 62 may… create a pocket of micro-fractured tissue increasing the surface area for lower pressure threshold, thereby permitting flow to resume”) (Examiner Notes: Based on the prior art’s disclosure, it is clear that the vibration extends to below the bottom surface of the housing as it is affecting the tissues under the skin), wherein the generated vibrations have a duration and a frequency (Examiner Notes: Duration and frequency are inherent properties of vibrations).
Claim(s) 2,3, and 5-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring, in view of Finan, further in view of Bajaj (WO2019094440), hereafter Bajaj.
Regarding Claim 2, the modified Ring discloses the wearable drug delivery device of claim 1, but is silent on wherein the vibrational actuator is positioned at an angle with respect to the bottom surface.
However, Bajaj teaches a vibration system, where a vibrational actuator is mounted at an angle to a bottom surface (par. 0411, “Vibration Actuators mounted onto a mounting platform such as a base plate, sub-frame, housing, or enclosure”; Fig. 14). Furthermore, mounting the vibrational actuator at an angle does not change the functionality of the device. Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Ring, and mount the vibrational actuator at an angle as taught by Bajaj.
Regarding Claim 3, the modified Ring discloses the wearable drug delivery device of claim 1, wherein the vibrational actuator is positioned within the at least one housing (Ring, par. 0055, “a wearable drug delivery device has a housing 200”), but is silent on operable to transmit the generated vibrations either transverse or parallel to a central axis of the at least one housing.
However, Bajaj further teaches a configuration of vibrational actuators, where the vibrational actuators can vibrate in a traverse or parallel direction in view of the bottom surface of the housing (Bajaj, Fig. 10, F1 and F2). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Ring, with the configuration of vibrational actuators of Bajaj as taught by Bajaj.
Regarding Claim 5, the modified Ring discloses the wearable drug delivery device of claim 1, wherein the vibrational actuator is an electric motor having a shaft and an eccentric weight coupled to the shaft of the electric motor (Ring, par. 0049, “the vibration generator may be in the form of a motor having a shaft with an eccentric weight attached to the shaft”; Bajaj, par. 0322, “the vibration device 310 includes a pair of rotary vibration actuators 312 and 314, each having an eccentric mass 316 and 318”), and controllable to transmit the generated vibrations at a frequency up to approximately 300 Hz (Bajaj, par. 0374 “by way of example only, ω may vary between 10 Hz and 100 Hz…”) (Examiner Notes: Both Ring and Bajaj teaches a electric motor with eccentric weight for vibration, while Bajaj specifies the range. The range in Bajaj is within the claimed range, therefore, the claimed range is anticipated by the prior arts).
Regarding Claim 6, the modified Ring discloses the wearable drug delivery device of claim 1, but is silent on wherein the vibrational actuator is a first vibrational actuator and a second vibrational actuator.
However, Bajaj teaches a first and second vibrational actuators mounted on a platform (par. 0288, “actuator 202 and actuator 204”; See Fig. 10). Bajaj further teaches that by having two vibrational actuators, the direction of the vibration can be controlled by varying the magnitude of the vibration force (par. 0289; See Fig. 11). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Ring, with the two vibrational actuators of Bajaj, to allow precise control of the magnitude and direction of the vibration (Bajaj, par. 0288-0289).
Regarding Claim 7, the modified Ring discloses The wearable drug delivery device of claim 6, wherein: the first vibrational actuator is positioned within the at least one housing to transmit, when actuated, vibrations in a first direction that are substantially parallel to a central axis of the at least one housing (See Bajaj Fig. 176, the vibrational actuators are positioned parallel to the centra axis), the second vibrational actuator is positioned within the at least one housing to transmit vibrations, when actuated, in a second direction that are substantially parallel to the central axis of the at least one housing, and the first direction is opposite to the second direction (Bajaj Fig. 176, See Fig A below) and the first vibrational actuator and second vibrational are alternately actuated (Examiner Notes: Bajaj par. 0251 and Fig. 1 shows vibrational actuator performing periodic motion, therefore, the vibrational actuators of the prior arts is capable of actuating alternately).
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Fig A. Applicant Fig. 1B (Left) vs Bajaj Fig. 176 (Right)
Regarding Claim 8, the modified Ring discloses the wearable drug delivery device of claim 6, wherein: the first vibrational actuator and the second vibrational actuator are controllable to be simultaneously actuated to transmit the generated vibrations in a direction that is transverse to a central axis of the at least one housing (Bajaj, par. 0289, “By varying the magnitude of the vibration force in the actuators 202, 204, it becomes possible to control the direction of vibration of the combined force effect”; See Fig. 10-14, the direction of the vibration can be controlled); or the first vibrational actuator and the second vibrational actuator are positioned at opposing angles that enable the controller to control the first vibrational actuator and the second vibrational actuator to generate variable vibration patterns (Bajaj Fig. 176).
Regarding Claim 9, the modified Ring discloses the wearable drug delivery device of claim 6, wherein the first vibrational actuator is a piezo ceramic transducer (Bajaj, par. 0343, “For instance, piezoelectric devices…”; Ring, par. 0049 “the vibration generator may be in the form of a piezoelectric vibrator”), and the second vibrational actuator is an electric motor having a shaft and an eccentric weight coupled to the shaft of the electric motor (Bajaj, par. 0320, “The actuator 300 includes an eccentric mass 302 coupled to a rotary actuator 304 along a shaft 306”; Ring, par. 0049 “The vibration generator may be in the form of a motor having a shaft with an eccentric weight”) (Examiner Notes: Both Ring and Bajaj disclose their vibrational actuator maybe a motor or a piezo element, in addition, such forms of vibrational actuators are well known technologies in the field. It would have been obvious to use these vibrational actuators as claimed).
Regarding Claim 10, the modified Ring discloses the wearable drug delivery device of claim 1, but is silent on the controller is further operable to output a modulated control signal to the vibrational actuator, and in response to the modulated control signal, the vibrational actuator is configured to generate modulated vibrations.
However, Bajaj further teaches a controller for the vibrational actuators, that can output vibration signals to generate modulated vibrations (par. 0399, “the amplitude of the vibration signal can be modulated with a PWM signal, where the duty cycle of the signal is proportional to the amplitude of vibration”). Bajaj then teaches using a modulated signal can simplify the circuitry (par. 0399, “to further simplify the vibration controller circuitry and lower cost…”). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Ring, with the controller of Bajaj, to output modulated signals and generate modulated vibrations to simply the circuitry (Bajaj, Par. 0399).
Regarding Claim 11, the modified Ring discloses the wearable drug delivery device of claim 1, wherein the controller is further operable to: determine that a rate of drug infusion is less than an infusion rate threshold ; and based on the determination, output the control signal to actuate the vibrational actuator (Ring, par. 0002, “At such high flow rates, the flow of a drug can become interrupted when a buildup of pressure occurs at the tip of the needle”; par. 0029, “a controller 56 that is operatively coupled to the reservoir 52”; par. 0049, “Actuation of the vibration generator 62 may dislodge an obstruction or blockage from the end of the cannula 54”) (Examiner Notes: The prior art discloses during infusion, pressure build up may occur and slow down the infusion, the controller controls drug administrating and the vibration, wherein the vibration permits normal infusion flow. One of ordinary skilled in the art would understand that the claimed limitation is how the prior art intended to function).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring, in view of Finan, further in view of Chao Uei et al. (US20120089081), hereafter Chao.
Regarding Claim 4, the modified Ring discloses the wearable drug delivery device of claim 1, wherein the vibrational actuator is a piezo ceramic transducer (Ring, par. 0049, “Alternatively, the vibration generator may be in the form of a piezoelectric vibrator”) (Examiner Notes: One of ordinary skilled in the art would understand that a piezoelectric vibrator is the equivalent of a piezo ceramic transducer).
The modified Ring is silent on that the piezo ceramic transducer is controllable to transmit the generated vibrations at a frequency between approximately 1 MHz and approximately 10 MHz.
However, Chao teaches a piezo transducer, which can provide vibrations between 10kHz and 100MHz (par. 0007). In addition, there is no criticality regarding the claimed range disclosed in the applicant’s disclosure. Therefore, it would have been obvious for one of ordinary skilled in the art to operate the device of Ring at a vibration frequency between 1MHz and 10MHz.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ring, in view of Finan, in view of Bajaj, further in view of Visweswara et al. (US20210358617), hereafter Vis.
Regarding Claim 12, the modified Ring discloses the wearable drug delivery device of claim 1, but is silent on further comprising: two or more ordinate sensors located at fixed positions within the at least one housing, wherein each respective ordinate sensor of the two or more ordinate sensors is operable to output a signal indicating a respective orientation; and wherein the controller is operable to: receive the signal output from each respective ordinate sensor of the two or more ordinate sensors; determine an attachment location of the wearable drug delivery device on the user; and output an indication of the attachment location to cause selection of a vibrational event schedule.
However, Vis teaches a on body sensor system, usable with wearable devices that are mountable on the body (par. 0002), the system includes two skin units that output an signal at a location of the user’s skin to a controller (par. 0082, Fig. 3). Vis further teaches by having the location sensor it allows for accurate placement of the wearable device (par. 0004, “Accurate placement of the patch upon replacement is important…”). In the case of a wearable drug delivery device, one of ordinary skilled in the art would recognize the importance of having accurate placement of the attachment site. Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known device of Ring, with the location sensor system of Vis, to have signal output of an attachment location of the device for accurate placement as taught by Vis (Vis, par. 0004).
The modified Ring is still silent on output an indication of the attachment location to cause selection of a vibrational event schedule.
However, the claimed vibration even schedule is merely a mode of operation of the vibrational actuator. The prior art already discloses both a vibration actuator and a location sensing system. In addition, the prior art discloses the vibration actuator capable of operating for specific time intervals (See Bajaj, par. 0251), which is equivalent to the claimed vibrational even schedule. Therefore, it would have been obvious for one of ordinary skilled in the art to operate the device such that a detected location triggers a vibration.
Regarding Claim 13, the modified Ring discloses the wearable drug delivery device of claim 12, wherein the controller is operable to: receive an ordinate sensor signal output from an ordinate sensor positioned in the at least one housing (Vis, par. 0082); and output the ordinate sensor signal to be transmitted via a transceiver to a management device that is external to the wearable drug delivery device (Examiner Notes: Finan, par. 0020 teaches the processor and the controller can be connected to external devices. Transceiver is a commonly used electronic in the field and an ordinary processor would inherently include a transceiver for communication. It would have been obvious for one of ordinary skilled in the art to transmit the location information to an external device.).
Claim(s) 14 , 15, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finan, in view of Ring.
Regarding Claim 14, Finan discloses a non-transitory computer readable medium embodied with programming code executable by a processor (par. 0025, “electronic signal processing components including a central processing unit and memory elements for storing control programs and operation data”), and the processor when executing the programming code is operable to: establish a wireless connection with a controller (Fig. 1 controller 104) of a wearable drug delivery device (Fig. 1, drug delivery device 102, par. 0024, “In one configuration, the controller 104 will wirelessly gather the necessary information (e.g., insulin history) from the drug delivery device 102”) receive signals related to a user's blood glucose measurement values (par. 0015, “The controller is configured to receive glucose levels of the subject from the glucose sensor”); determine that the user's blood glucose passes a threshold percentage of a target blood glucose setting (par. 0015, “The controller is configured to automatically calculate a basal insulin dose… including desired glucose levels, amounts of the delivered insulin and the measured glucose levels of the subject”; desired glucose level is a threshold percentage; par. 0043, “calculating a function of a difference between a present glucose level of the subject and a target glucose level of the subject”; the difference between the user’s glucose and the target glucose is calculated);.
Finan further discloses determine, in response to the determination, the insulin output level (par. 0043, “the method 200 at block 260 modifies the manual bolus insulin dose based on the physiological data of the subject”) is silent on determine, in response to the determination settings to implement a vibrational event for the wearable drug delivery device, wherein the determined settings include a duration of the vibrational event and a frequency of a vibration to be generated during the vibrational event.
However, Ring teaches a wearable drug delivery device (Ring, Fig. 17, a wearable drug delivery device), and a controller (par. 0049, controller 56), wherein the controller determine settings to implement a vibrational event for the wearable drug delivery device (Ring, par. 0049, “vibration generator 62 may be controlled by the controller 56 to which it is operatively coupled”), wherein the determined settings include a duration of the vibrational event and a frequency of a vibration to be generated during the vibrational event (Ring, par. 0049, “Actuation of the vibration generator 62 may… create a pocket of micro-fractured tissue increasing the surface area for lower pressure threshold, thereby permitting flow to resume) (Examiner Notes: Duration and frequency are inherent properties of vibrations). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known medium of Finan, with the drug delivery device of Ring, to generate vibration to prevent obstruction and ensure proper flow as taught by Ring (Ring, par. 0049).
The modified Finan further discloses output a command signal containing instructions for the controller of a wearable drug delivery device to actuate vibrational actuators to implement the vibrational event according to the determined settings within the wearable drug delivery device (Examiner Notes: Finan, par. 0019-0020 discloses the controller outputting command signal to deliver bolus to the patient, par. 0025 discloses the drug delivery device may include various drug delivery mechanism. Therefore, after the modification, the medium of Finan would output a command signal to instruct the device of Ring to actuate the vibrational actuators for delivering drug).
Regarding Claim 15, the modified Finan discloses the non-transitory computer readable medium of claim 14, further embodied with programming code executable by the processor, and the processor, when executing the programming code to determine the settings to implement the vibrational event, is operable to: access a database storing information related to the settings associated with the vibrational event to be implemented on the wearable drug delivery device (Finan, par. 0020, “The controller 104 can be configured to include a closed-loop controller that has been programmed to receive continuous glucose readings from a CGM sensor 112 via a communications link 110”), wherein the information related to the settings includes user preferences related to the vibrational event, wearable drug delivery device sensor indications, or time of day (Examiner Notes: Ring, par. 0049 discloses the controller is configured to adjust vibration parameters, Finan par. 0020 discloses the information received includes sensor indications and is used to adjust delivery parameters); and using the information related to the settings, determine when to output the command signal to the controller of the wearable drug delivery device (Finan, par. 0033, “the controller… by a predictive closed-loop control algorithm that uses as one of its inputs the glucose values communicated by the CGM sensor 112, the glucose meter 114, or both at specific time intervals”).
Regarding Claim 20, Finan discloses a system (Fig. 1), comprising: a personal diabetes management device (Fig. 1, a diabetes management system 100), the personal diabetes management device including: a processor (par. 0025, “a central processing unit”), a memory storing programming code (par. 0025, memory elements for storing control programs) and a site maintenance application (par. 0027, “The controller 104 is a smartphone running an application), wherein the programming code and the site maintenance application are executable by the processor; (par. 0031, “The received code can be executed by the controller 104 as it is received, or stored for later execution”), a touchscreen display device coupled to the processor and configured to receive inputs and present a graphical user interface (Fig. 1, controller 104, par. 0021, “The controller 104 can present information and receive commands via a user interface, such as the displayed touchscreen 144”), and a transceiver coupled to the processor and be configured to receive and transmit signals containing information of the site maintenance application (par. 0020, “The drug delivery device 102 is configured to transmit and receive data to and from the controller 104 by, for example, a communications link 111”). And a wearable drug delivery device (Fig. 1, drug delivery 102 is wearable to a user), the wearable drug delivery device including: a drug delivery device transceiver configured to be coupled via a wireless communication link with the personal diabetes management device (Finan, par. 0024, “the controller 104 will wirelessly gather the necessary information (e.g., insulin history) from the drug delivery device 102”); a reservoir configured to contain insulin (par. 0025, “The drug delivery device 102 can include any or all of… a drug delivery mechanism (e.g., a drug pump and drive mechanism) for forcing insulin from an insulin reservoir (e.g., an insulin cartridge)”); a drive mechanism coupled to the reservoir and configured to expel the insulin from the reservoir (par. 0025, “a drug delivery mechanism (e.g., a drug pump and drive mechanism) for forcing insulin from an insulin reservoir (e.g., an insulin cartridge)”).
Finan is silent on a vibrational actuator configured to generate vibrations.
However, Ring teaches a system, comprising: a wearable drug delivery device (Fig. 17, a wearable drug delivery device), the wearable drug delivery device including: a reservoir configured to contain insulin (Claim 38, “insulin disposed in the reservoir”); a drive mechanism coupled to the reservoir and configured to expel the insulin from the reservoir (par. 0029 “a drive, which may be mechanical, electromechanical, or electrical, that is operatively coupled to the reservoir 52 to force fluid from the reservoir 52 through the blunt cannula 54”); a vibrational actuator configured to generate vibrations (vibration generator 62); and a controller coupled to the drug delivery device transceiver, the drive mechanism and the vibrational actuator (par. 0029 and 0049, controller 56). Therefore, it would have been obvious for one of ordinary skilled in the art to modify the known system of Finan, with the wearable drug delivery device of Ring, to generate vibration to prevent obstruction and ensure proper flow as taught by Ring (Ring, par. 0049).
The modified Finan further discloses a controller coupled to the drug delivery device transceiver, the drive mechanism and the vibrational actuator (Finan, par. 0020, a controller 104; Ring, par. 0029 and 0049, controller 56), wherein the controller is configured to receive command signals from the personal diabetes management device (Examiner Notes: The claimed limitation is merely how the device intends to function), and wherein the processor of the personal diabetes management device when executing programming code is configured to: receive signals related to a user's blood glucose measurement values (Finan, par. 0015, “The controller is configured to receive glucose levels of the subject from the glucose sensor”); determine that the user's blood glucose passes a threshold percentage of a target blood glucose setting (Finan, par. 0015, “The controller is configured to automatically calculate a basal insulin dose… including desired glucose levels, amounts of the delivered insulin and the measured glucose levels of the subject”; desired glucose level is a threshold percentage; par. 0043, “calculating a function of a difference between a present glucose level of the subject and a target glucose level of the subject”; the difference between the user’s glucose and the target glucose is calculated); prior to transmitting a command signal causing the drive mechanism to deliver a bolus dosage of insulin from the reservoir transmit, according to a vibrational event schedule, and in response to the determination (Finan, par. 0043, “the method 200 at block 260 modifies the manual bolus insulin dose based on the physiological data of the subject”) a vibrational event command signal to the wearable drug delivery device (Examiner Notes: See Ring, par. 0049, the prior art discloses the vibration occurs to resume the flow of the drug delivery, the vibration is prior to delivering the dosage to remove possible obstruction; par. 0060, “In addition, by vibrating the tissue, according to the mechanism of FIG. 16, some of the residual force in the skin tissue 210 may be released, thereby decreasing the pressure and potential for occlusion”, the term “potential” renders the system capable of performing vibration prior to delivering dosage to prevent potential blockages.), wherein the vibrational event command signal includes a vibration duration and a vibration frequency (Examiner Notes: Duration and frequency are inherent properties of vibrations); wherein the controller of the wearable drug delivery device is configured to: in response to the vibrational event command signal, send a control signal to actuate the vibrational actuator (Ring, par. 0049, “The operation of the vibration generator 62 may be controlled by the controller 56 to which it is operatively coupled.”).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finan, in view of Ring, further in view of Vis.
Regarding Claim 16, the modified Finan discloses the non-transitory computer readable medium of claim 14, further embodied with programming code executable by the processor. But is silent on the processor when executing the programming code is operable to: receive an orientation signal from the wearable drug delivery device; determine, in response to the received orientation signal, an attachment location of the wearable drug delivery device on a user; and select a vibrational event schedule corresponding to the determined attachment location.
However, Vis teaches a on body sensor system, usable with wearable devices that are mountable on the body (par. 0002), the system includes two skin units that output an signal at a location of the user’s skin to a controller (par. 0082, Fig. 3). Vis further teaches by having the location sensor it allows for accurate placement of the wearable device (par. 0004, “Accurate placement of the patch upon replacement is important…”). Furthermore, the system of Vis is capable of outputting a signal to cause a vibration (par. 0125, “output information may be generated… This may be via a sensory output device such as… a haptic output device (e.g. vibration of the wearable device)”), it would have been obvious to correlate the signal output with the vibrational actuators from Ring. In the case of a wearable drug delivery device, one of ordinary skilled in the art would recognize the importance of having accurate placement of the attachment site. Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known computer readable medium of Finan, with the location sensor system of Vis, to have signal output of an attachment location of the device for accurate placement as taught by Vis (Vis, par. 0004).
Claim(s) 17, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finan, in view of Ring, further in view of Bajaj.
Regarding Claim 17, the modified Finan discloses the non-transitory computer readable medium of claim 14, further embodied with programming code executable by the processor, and the processor when executing the programming code is operable to: output a command signal to the controller of the wearable drug delivery device (Finan, par. 0033, “the controller 104 commands the drug delivery device 102 to deliver the patient's pre-set basal rates modulated”), where the command signal includes instructions for actuating a vibrational actuator (Examiner Notes: The steps of operating the vibrational actuator is the intended way of function of the prior art, see Ring par. 0049, see rejection for Claim 14 above)
The modified Finan is silent on wherein the instructions are a first instruction for actuating a first vibrational actuator and second instructions for actuating a second vibrational actuator.
However, Bajaj teaches a first and second vibrational actuators mounted on a platform (par. 0288, “actuator 202 and actuator 204”; See Fig. 10). Bajaj further teaches that by having two vibrational actuators, the direction of the vibration can be controlled by varying the magnitude of the vibration force (par. 0289; See Fig. 11). Bajaj then teaches that the direction and magnitudes of the first and second vibrational actuators can be controlled (Bajaj, par. 0288-0299), and the controller of the modified prior art is capable of controlling a vibration actuator (See rejection for claim 14 above). Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the known computer readable medium of Finan, with the first and second vibrational actuators of Bajaj, to allow precise control of the magnitude and direction of the vibration (Bajaj, par. 0288-0289).
Regarding Claim 18, the modified Finan discloses the non-transitory computer readable medium of claim 14, further embodied with programming code executable by the processor, and the processor, but is silent on when executing the programming code, is operable to: establish a vibrational event schedule according to user preferences, wherein the user preferences enable scheduling of the vibrational event at specific times during a day and selection of vibrational event settings, wherein: establishing the schedule of the vibrational event includes selection of daylight hours during which the vibrational event is administered, selection of evening hours during which the vibrational event is administered, or a combination of both daylight hours and evening hours; and selection of vibrational event settings includes selection of a duration of the vibrational event, selection of a high frequency range, a medium frequency range, or a low frequency range, and identification of site-based adjustments to the vibrational event schedule and the selected vibrational event settings, wherein the outputting of the command signal is based on the vibrational event schedule for the vibrational event to be implemented.
However, Bajaj further teaches a vibrational actuator where the actuator vibrates periodically, with a period of time T (Bajaj, par. 0256, Fig. 1). Such time T can be varied to adjust the time between each vibration (Bajaj, par. 0977-0978). The applicant claims a schedule of vibrational event for daylight and evening hours merely adjusts the timing of the vibrations, which is a predictable modification based on what the prior art already teaches. Bajaj already discloses adjusting the timing of vibrations, and scheduling vibrations based on different times of the day does not produce any unexpected results. Therefore, the claimed feature would have been obvious for one of ordinary skilled in the art in view of the prior art.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Finan, in view of Ring, in view of Vis, further in view of Shor (US20190009019).
Regarding Claim 19, the modified Finan discloses the non-transitory computer readable medium of claim 14, further embodied with programming code executable by the processor, and the processor, on when executing the programming code, is operable to: determine a location of the wearable drug delivery device on the user (Vis, par. 0004) and adjust a vibrational event schedule and vibrational even setting based on the determined location of the wearable drug delivery device on the user (See Claim 16 above).
The modified Finan is silent on obtain a determination of a level of physical activity of a user of the wearable drug delivery device; and adjust a vibrational event schedule and vibrational event settings based on the determination of the level of physical activity of the user.
However, Shor teaches a wearable drug delivery device (device 100), including a control unit (control unit 116), where the control unit can receive a signal from a movement sensor. The movement sensor indicates the level of physical activity of the user, the control unit then decides the level of dosage of the drug delivered to the patient based on the information received from the sensor (par. 0202). Ring further discloses that the vibration is to help the process of drug delivery, and is used in combination with the drug delivery process. One of ordinary skilled in the art would understand the impact of physical activity on drug delivery for the user. Therefore, it would have been obvious for one of ordinary skilled in the art to further modify the computer readable medium of Finan, with the movement sensor of Shor, to help maintain a stable health condition during the vibration (Shor, par. 0202).
Response to Arguments
Applicant's arguments filed 02/12/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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 KRIS HANYU GONG whose telephone number is (703)756-5898. The examiner can normally be reached M-F 8:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRIS HANYU GONG/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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