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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-9, and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Favreau (US Pub. No 2013/0253419).
Regarding claim 1, Favreau discloses a mobile or wearable drug delivery device (infusion device 200, Fig. 2), comprising;
an electric motor (motor 232, Fig. 3) comprising a rotor at an output ("… a motor 232 having a rotor …" - Para [0032]);
an electronic control unit (motor control module 702, Fig. 7) configured to control commutation or rotation of the rotor ("… the motor driver module 706 is coupled to the motor control module 702 to receive a commanded number of motor steps from the motor control module 702 …" - Para [0039]) and to intermittently advance an angular position of the rotor ("… a "motor step" or any variant thereof should be understood as referring to an incremental rotation of the rotor of the motor 708 …" - Para [0038]) by a number of steps to convey a predefined amount of drug over a plurality of delivery cycles ("an incremental rotation of the rotor by one motor step produces a corresponding amount of displacement of a stopper 750 (e.g., stopper 222) into a reservoir (e.g., reservoir 206) to deliver fluid (e.g., insulin) to the body of a user." - Para [0038]),
wherein the electronic control unit is adapted to, for each of the plurality of delivery cycles ("… preprogrammed delivery routines." - Para [0025]), over-revving by commutating the rotor for a certain amount of steps (Operate motor to achieve number of motor steps in command block, 808, Fig. 8) allocated to a respective delivery cycle of the plurality of delivery cycles, and by continuing to commute for a predefined number of extra steps or micro-steps after reaching a target position (Increase number of motor steps in subsequent step command block to compensate for missed motor steps, 822, Fig. 8).
Regarding claim 2, Favreau discloses the mobile or wearable drug delivery device (infusion device 200, Fig. 2) as recited above, wherein
the electronic control unit (motor control module 702, Fig. 7) is adapted to reverse the rotor or commutation for a small number of steps or micro-steps ("… the motor control module 702 determines the PWM width setting should be decreased when the motor 708 successfully completes one thousand motor steps with a constant duty cycle." - Para [0053]) with each of the plurality of delivery cycles.
Regarding claim 3, Favreau discloses the mobile or wearable drug delivery device (infusion device 200, Fig. 2) as recited above, wherein
the predefined number of extra steps or micro-steps is between .25 full motor steps and 1.25 full motor steps("… commanding the motor driver module 706 to provide one motor step of rotation …" - Para [0043]).
Regarding claim 4, Favreau discloses the drug delivery device (infusion device 200, Fig. 2) as recited above wherein the electronic control unit includes one or more elements (“a magnetic sensor, optical sensor (or other light detector), tactile sensor, capacitive sensor, inductive sensor…”, “the incremental position sensor 500”, Para [0035]) configured to measure or estimate at least one supervision parameter ([Para 0035]) of: a rotor position (812) or a loss of steps (820) (Fig. 8).
Regarding claim 5, Favreau discloses the drug delivery device (infusion device 200, Fig. 2) as recited above wherein the electronic control unit is adapted to compare at least one of the supervision parameters with a predefined reference value (“expected displacement” – Para [0021]) to detect an error condition (“designed to detect and indicate a pump malfunction and/or non-delivery of the medication to the patient due to a fluid path” – Para [0003]) (902) (Fig. 9).
Regarding claim 6, Favreau discloses the drug delivery device (infusion device 200, Fig. 2) as recited above wherein the error condition includes a blockage of the electric motor or an occlusion of a fluid (“to detect an occlusion in a fluid path while delivery fluid to a user…” – Para [0057]) path at an output of the drug delivery device (908, 910) (Fig.9).
Regarding claim 8, Favreau discloses the drug delivery device (infusion device 200, Fig. 2) as recited above wherein the drug delivery device is a patch pump (“the following description focuses on a fluid infusion device (or infusion pump) …conventional techniques related to infusion system operation, insulin pump…” – Para [0023]) attachable to skin of a patient (“temporarily adhered to the skin of the user” – Para [0030]).
Regarding claim 9, Favreau discloses the drug delivery device as recited above wherein the drug delivery device is configured as an infusion device (Para [0003]) and comprises a drive mechanism (230), a reservoir (206) to contain a liquid drug, and a movable plunger (222), and wherein the drive mechanism is adapted to transform the rotation of the rotor into a displacement of the movable plunger to convey the drug out of the reservoir (Para [0003]) (Fig. 3 & 2).
Regarding claim 13, Favreau discloses the drug delivery device as recited above wherein the motor includes a two-phase stepper motor (Para [0038]).
Regarding claim 14, Favreau discloses the drug delivery device as recited above wherein the motor includes a two-phase brushless DC motor (Para [0038]).
Regarding claim 16, Favreau discloses a method of controlling an electric motor in a drug delivery device (motor control process 800, Fig. 8), comprising;
over-revving by commutating a rotor of a mobile or wearable drug delivery device for a certain amount of steps allocated to a respective delivery cycle (Operate motor to achieve number of motor steps in command block, 808, Fig. 8) of a plurality of delivery cycles ("… preprogrammed delivery routines." - Para [0025]), and by continuing to commute for a predefined number of extra steps or micro-steps after reaching a target position (Increase number of motor steps in subsequent step command block to compensate for missed motor steps, 822, Fig. 8), the mobile or wearable drug delivery device (infusion device 200, Fig. 2) comprising;
an electric motor (motor 232, Fig. 3) comprising a rotor at an output ("… a motor 232 having a rotor …" - Para [0032]);
an electronic control unit (motor control module 702, Fig. 7) configured to control commutation or rotation of the rotor ("… the motor driver module 706 is coupled to the motor control module 702 to receive a commanded number of motor steps from the motor control module 702 …" - Para [0039]) and to intermittently advance an angular position of the rotor ("… a "motor step" or any variant thereof should be understood as referring to an incremental rotation of the rotor of the motor 708 …" - Para [0038]) by a number of steps to convey a predefined amount of drug ("an incremental rotation of the rotor by one motor step produces a corresponding amount of displacement of a stopper 750 (e.g., stopper 222) into a reservoir (e.g., reservoir 206) to deliver fluid (e.g., insulin) to the body of a user." - Para [0038]) over a plurality of delivery cycles ("… the infusion device 102 to deliver fluid to the body of the user based on the sensor data and/or preprogrammed delivery routines." - Para [0025]),
wherein the electronic control unit (motor control module 702, Fig. 7) is adapted to, for each of the plurality of delivery cycles, over-revving by commutating the rotor for a certain amount of steps (Operate motor to achieve number of motor steps in command block, 808, Fig. 8) allocated to a respective delivery cycle of the plurality of delivery cycles, and by continuing to commute for a predefined number of extra steps or micro-steps after reaching a target position (Increase number of motor steps in subsequent step command block to compensate for missed motor steps, 822, Fig. 8).
Regarding claim 17, Favreau discloses the method (motor control process 800, Fig. 8) as recited above, further comprising
reversing the rotor or commutation for a small number of steps or micro-steps ("… the motor control module 702 determines the PWM width setting should be decreased when the motor 708 successfully completes one thousand motor steps with a constant duty cycle." - Para [0053]) with each of the plurality of delivery cycles("… one thousand motor steps …" - Para [0053]).
Regarding claim 20, Favreau discloses a mobile or wearable drug delivery device (infusion device 200, Fig. 2), comprising;
an electric motor (motor 232, Fig. 3) comprising a rotor at an output ("… a motor 232 having a rotor …" - Para [0032]);
an electronic control unit (motor control module 702, Fig. 7) configured to control commutation or rotation of the rotor ("… the motor driver module 706 is coupled to the motor control module 702 to receive a commanded number of motor steps from the motor control module 702 …" - Para [0039]) and to intermittently advance an angular position of the rotor ("… a "motor step" or any variant thereof should be understood as referring to an incremental rotation of the rotor of the motor 708 …" - Para [0038]) by a number of steps to convey a predefined amount of drug over a plurality of delivery cycles ("an incremental rotation of the rotor by one motor step produces a corresponding amount of displacement of a stopper 750 (e.g., stopper 222) into a reservoir (e.g., reservoir 206) to deliver fluid (e.g., insulin) to the body of a user." - Para [0038]),
wherein the electronic control unit is adapted to, for each of the plurality of delivery cycles ("… preprogrammed delivery routines." - Para [0025]): over-revving by commutating the rotor for a certain amount of steps (Operate motor to achieve number of motor steps in command block, 808, Fig. 8) allocated to a respective delivery cycle of the plurality of delivery cycles, and continuing to commute for a predefined number of extra steps or micro-steps after reaching a target position (Increase number of motor steps in subsequent step command block to compensate for missed motor steps, 822, Fig. 8).
and reversing the commutation or the rotation of the rotor for a small number or micro-steps ("… the motor control module 702 determines the PWM width setting should be decreased when the motor 708 successfully completes one thousand motor steps with a constant duty cycle." - Para [0053]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US Pub. No. 2013/0253419 A1, herein, Favreau) in view of Mastrototaro et al. (US Pub. No. 2015/0217051 A1, herein Mastrototaro).
Regarding claim 7, Favreau in view of Mastrototaro discloses the mobile or wearable drug delivery device (Favreau, infusion device 200, Fig. 2) as recited above.
Favreau does not expressly disclose that the error condition includes underdelivery.
Mastrototaro teaches that an error condition includes underdelivery (“a number of different conditions may be detected that are indicative of potential anomalous conditions…”, “For example…overdelivery or underdelivery…” Para [0021]).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the error conditions detectable by the drug delivery device disclosed by Favreau to include underdelivery as taught by Mastrototaro in order to “notify the user or supervisory control system of the potential anomaly” (Mastrototaro, Para [0022]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US Pub. No. 2013/0253419 A1, herein, Favreau) in view of Pizzochero et al. (US Pub. No. 20190344010, herein, Pizzochero).
Regarding claim 10, Favreau in view of Pizzochero discloses the mobile or wearable drug delivery device (Favreau, infusion device 200, Fig. 2) as recited above.
Favreau does not expressly disclose that the drive mechanism includes a gearbox.
Pizzochero teaches that the drive mechanism includes a gearbox (1032) (Fig. 13).
Therefore, it would have obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the mobile or wearable drug delivery device as disclosed by Favreau to include a drive mechanism with a gearbox as taught by Pizzochero in order to increase accuracy and reliability of insulin patches (Pizzochero, Para [0036]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US Pub. No. 2013/0253419 A1, herein, Favreau) in view of Burren et al. (US Pub. No. 2020/0405951 A1, herein, Burren).
Regarding claim 11, Favreau in view of Burren discloses the mobile or wearable drug delivery device (Favreau, infusion device 200, Fig. 2) as recited above.
Favreau does not expressly disclose that the drive mechanism includes a plunger rod having at least one segment.
Burren teaches that the drive mechanism includes a plunger rod (140) having at least one segment (31) (Fig. 44).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to modify the mobile or wearable drug delivery device disclosed by Favreau to include a drive mechanism with a plunger rod having at least one segment as taught by Burren in order to further assist in expelling “medication through the cartridge needle…” (Burren, Para [152]).
Claim(s) 12, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US Pub. No. 2013/0253419 A1, herein Favreau) in view of Nguyen et al. (US Pub. No 2021/0020194, herein, Nguyen).
Regarding claim 12, Favreau discloses the mobile or wearable drug delivery device (Favreau, infusion device 200, Fig. 2) as recited above.
Favreau does not expressly disclose that the motor includes at least two stator coils to define at least four angular positions per 360° rotation of the rotor
Nguyen teaches that the motor includes at least two stator coils (814c) to define at least four angular positions per 360° rotation of the rotor (Para [0057]).
Therefore, it would have been obvious to one of the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the mobile or wearable drug delivery device as disclosed by Favreau to include at least two stator coils to define at least four angular positions per 360° rotation of the rotor in order to “achieve specific design goals such as torque, phases and rotational degrees/steps or steps/revolution” (Nguyen, Para [0090]).
Regarding claim 18, Favreau in view of Nguyen discloses the mobile or wearable drug delivery device (Favreau, infusion device 200, Fig. 2) as recited above, whereby
the electronic control unit (motor control module 702, Fig. 7)
Favreau does not expressly disclose that the electronic control unit is further adapted to using micro-stepping.
Nguyen teaches that the electronic control unit is further adapted to using micro-stepping ("… a micro-step may be used …" - Para [0057]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the mobile or wearable drug delivery device of Favreau to include that the electronic control unit is further adapted to using micro-stepping as taught by Nguyen to get a higher step resolution (Nguyen, Para [0057]).
Regarding claim 19, Favreau in view of Nguyen discloses the method (Favreau, motor control process 800, Fig. 8) as recited above, whereby
the electronic control unit (motor control module 702, Fig. 7)
Favreau does not expressly disclose that the electronic control unit is further adapted to using micro-stepping.
Nguyen teaches that the electronic control unit is further adapted to using micro-stepping ("… a micro-step may be used …" - Para [0057]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Favreau to include that the electronic control unit is further adapted to using micro-stepping as taught by Nguyen to get a higher step resolution (Nguyen, Para [0057]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Favreau (US Pub. No. 2013/0253419, herein Favreau).
Regarding claim 15, Favreau discloses the mobile or wearable drug delivery device as recited above wherein
the electronic control unit is adapted to rotate the rotor by a maximum of 100 full motor steps for a delivery cycle (Para [0039]).
Examiner interprets the electronic control unit disclosed by Favreau to be adapted to rotate the rotor by a particular number of commanded motor steps of rotation per delivery cycle. The number of commanded motor steps is determined by motor design including number of teeth of the rotor and/or arrangement of winding sets (Para [0039]), and thus varies based on the motor.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to set a range of 0-100 full motor steps per delivery cycle, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed on February 10th 2026 have been fully considered but they are not persuasive.
Applicant argues that tasks 820 and 822 are conditional steps based on the determination that the commanded rotation has not been achieved in task 814. Therefore, Favreau does not disclose its control module 702 causes the rotor 501 to be over-revved for each duty cycle, and thus Favreau does not disclose its control 702 is “adapted to, for each of the plurality of delivery cycles, over-revving by commutating the rotor for a certain amount of steps allocated to a respective delivery cycle of the plurality of delivery cycles, and by continuing to commute for a predefined number of extra steps or micro-steps after reaching a target position.
Examiner interprets the ability of the control module disclosed on Favreau to be able to over-rev the motor, given a condition is met, as a control module that is adapted to over-rev each delivery cycle given each cycle meets the condition.
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 ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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