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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/06/2025 considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 09/29/2025. As directed by the amendment: Claims 21, 24-28, 30, and 33-38 have been amended, no claims have been cancelled, and claim 39 has been added. Thus, claims 21-39 are presently pending in the application.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 09/29/2025, with respect to the rejection of the claims have been fully considered and are persuasive. Applicant argues that the previous references do not teach the amendments to the claims. Examiner agrees; therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Nayak (US 11806516) (discussed more below).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-39 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 21, 25-27, 30, 34-36, and 39, the phrase “particular” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05.
Claims 22-24 and 28-29 are rejected for depending on claim 21.
Claims 31-33 and 37-38 are rejected for depending on claim 30.
Claim Rejections - 35 USC § 103
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 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Paralikar (US 2019/0190296), in view of Nayak (US 11806516).
Regarding Claim 21, Paralikar discloses a method, comprising: charging a battery (18; Fig.1) of an ambulatory infusion pump (14; Fig.14) by transmitting power to the ambulatory infusion pump at a first charging rate or power (“high” power level) using an inductive charging device (22) (first sentence in parag. [0034] and parag. [0062]), wherein the ambulatory infusion pump (14) is configured to contain a medicament (lines 8-10 in parag. [0039]); obtaining a temperature value within the ambulatory infusion pump (14) while charging the battery (18) of the ambulatory infusion pump at the first charging rate or power (last sentence in parag. [0063]); determining whether the temperature value meets or exceeds a predetermined threshold (parag. [0062]) corresponding to a particular temperature at which the medicament can be negatively affected; and responsive to determining that the temperature value does not meet or exceed the predetermined threshold, causing the inductive charging device to continue to transmit power to the ambulatory infusion pump at the first charging rate or power (the charging device 22 may continue to charge the rechargeable power source at a “high” power level in response to the temperature not exceeding the threshold) (parag. [0062]); and responsive to determining that the temperature value meets or exceeds the predetermined threshold, (i) causing the inductive charging device to reduce the first charging rate or power to a second charging rate or power (“low” power level), lower than the first charging rate or power (the charging device 22 will select a “low” power level in response to the temperature exceeding a threshold) (parag. [0062]).
Paralikar does not appear to disclose notifying a user of the ambulatory infusion pump regarding the reduction and the temperature value.
Nayak teaches it was known in the art to have an output device that notifies a user of a drug delivery device when a temperature of a medicament meets a threshold temperature via an audio, visual, or haptic output (lines 8-12 in column 10). Modifying Paralikar with the output device to notify the user when the temperature meets or exceeds the temperature threshold (from Nayak) would also notify the user regarding the reduction, since the charging rate in Paralikar is reduced when the temperature exceeds the threshold (parag. [0062])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paralikar to incorporate the teachings of Nayak to notify a user of the ambulatory infusion pump regarding the reduction and the temperature value in order to alert the user when the medicine’s temperature meets the threshold (lines 8-12 in column 10).
Regarding Claim 22, Paralikar as modified discloses the method of claim 21, and further wherein the second charging rate or power (“low” power level) is a non-zero value (the “low” power level is less than the “high” power level (the “low” power level is minimal), and the “low” power level is non-zero (since the power source (18) will be charged at a lower rate)) (parag. [0062]).
Regarding Claim 23, Paralikar as modified discloses the method of claim 21, and further discloses wherein the second charging rate or power (“low” power level) (parag. [0062]) is a zero value, such that charging the battery of the ambulatory infusion pump is suspended at the second charging rate or power (last sentence in parag. [0059]).
Regarding Claim 24, Paralikar as modified discloses the method of claim 21, and further discloses wherein the first charging rate (“high” power level) is a maximum charging rate that the inductive charging device can provide (lines 4-6 in parag. [0063]).
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Paralikar (US 2019/0190296), in view of Nayak (US 11806516) and Labbe (US 2014/0070761).
Regarding Claim 25, Paralikar as modified discloses all the limitations of claim 21 above.
Paralikar does not appear to disclose prior to initiating charging, determining an initial temperature value within the ambulatory infusion pump and initiating charging responsive to determining that the initial temperature value does not meet or exceed the particular temperature at which the medicament can be negatively affected.
Labbe teaches it was known in the art to have a method for determining an initial temperature value (via temperature sensors) within an implantable medical device 10 (Fig.1) (parag. [0010]) before initiating charging of a rechargeable battery (via external charger 2) and only initiating charging if the temperature does not meet or exceed (below) the upper limit temperature (threshold) (parag. [0042]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paralikar to incorporate the teachings of Labbe prior to initiating charging, determining an initial temperature value within the ambulatory infusion pump and initiating charging responsive to determining that the initial temperature value does not meet or exceed the particular temperature at which the medicament can be negatively affected in order to prevent undesirable temperature levels (avoid exceeding temperature limitations) on the medical device (parag. [0042]).
Regarding Claim 26, Paralikar as modified discloses the method of claim 25, and Nayak further teaches comprising providing a notification (output device in Nayak) to a user. Labbe further teaches that charging has not been initiated responsive to determining that the initial temperature value meets or exceeds the particular temperature at which the medicament can be negatively affected (parag. [0042]).
Regarding Claim 27, Paralikar as modified discloses the method of claim 21, and further discloses comprising an initial temperature value (parag. [0027]). Labbe further teaches prior to initiating charging, determining an initial temperature value within the ambulatory infusion pump (parag. [0010]), and initiating charging at the second charging rate or power (c/8) rather than the first charging rate or power (c/4) responsive to determining that the initial temperature value meets or exceeds the particular temperature at which the medicament can be negatively affected (parags. [0041]- [0042]) (Fig.5).
Regarding Claim 28, Paralikar as modified discloses all the limitations of claim 21 above.
Paralikar does not appear to disclose while charging the battery of the ambulatory infusion pump at the second charging rate or power, obtaining another temperature value within the ambulatory infusion pump; and increasing the charging rate or power to the first charging rate or power responsive to determining that the other temperature value does not meet or exceed the predetermined threshold.
Labbe teaches it was known in the art to have a method for recharging a battery in an implantable medical device and increasing the charging rate to a first charging rate (C/4; Fig.5) if the temperature does not meet or exceed (below) the threshold temperature while the inductive charging device is transmitting power at the second charging rate (C/8; Fig.5) (parag. [0039]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paralikar to incorporate the teachings of Labbe to charge the battery of the ambulatory infusion pump at the second charging rate or power, obtaining another temperature value within the ambulatory infusion pump; and increasing the charging rate or power to the first charging rate or power responsive to determining that the other temperature value does not meet or exceed the predetermined threshold in order to prevent the level of heat within the device from reaching undesirable levels while maximizing the speed at which the device can be charged by maximizing the amount of time the device is charged at a high charge rate, since the lower charging rate increase charging times for medical devices (parag. [0008]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Paralikar (US 2019/0190296), in view of Nayak (US 11806516) and Almendinger (US 2013/0238048).
Regarding Claim 29, Paralikar as modified discloses the method of claim 21, and further discloses comprising: charging the battery of the ambulatory infusion pump at the first charging rate or power (last sentence in parag. [0063]).
Paralikar does not appear to disclose obtaining a rate of change of temperature within the ambulatory infusion pump and controlling the inductive charging device to continue or reduce transmission of power to the ambulatory infusion pump based on the rate of change of temperature.
Almendinger teaches it was known in the art to have methods and systems for charging a battery of an implantable device by having a microprocessor for determining a rate of rise (rate of change) of temperature values (parag. [0014]). The external charger stop sending charge if the rate of temperature rise exceeds a predetermined maximum (second threshold level) (the microprocessor configured to determine if the rate of rise of the temperature or if the temperature exceeds a predetermined maximum as compared to the baseline, and configured to communicate to the external charger to stop sending charge or to change the power level of the charge if the rate of temperature rise exceeds a predetermined maximum or if the temperature exceeds a predetermined maximum; parag. [0014], lines 14-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paralikar to incorporate the teachings of Almendinger to obtain a rate of change of temperature within the ambulatory infusion pump and controlling the inductive charging device to continue or reduce transmission of power to the ambulatory infusion pump based on the rate of change of temperature in order to reach the allowable temperature very quickly and to achieve a lower rate of temperature rise to allow charging to proceed without exceeding temperature limit (parag. [0148]).
Claims 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0184907), in view of Paralikar (US 2019/0190296) and Nayak (US 11806516).
Regarding Claim 30, Smith discloses an ambulatory infusion pump system (200; Fig.1) configured for delivery of a medicament (lines 6-7 in parag. [0046]), comprising: a drive mechanism (106; Fig10) configured to attach with a cartridge (100) for delivery of the medicament to a user (lines 6-7 in parag. [0046]); a battery (238) configured to be charged based on transmitted power at a first charging rate or power using an inductive charging device (300-302) (parags. [0008] and [0060]); and a processor (237).
Smith does not appear to disclose obtaining a temperature value within the ambulatory infusion pump while the battery is being charged at the first charging rate or power; determining whether the temperature value meets or exceeds a predetermined threshold corresponding to a particular temperature at which the medicament be negatively affected; responsive to determining that the temperature value does not meet or exceed the predetermined threshold, cause the inductive charging device to continue to transmit power to the ambulatory infusion pump at the first charging rate or power; and responsive to determining that the temperature value meets or exceeds the predetermined threshold, (i) cause the inductive charging device to reduce the first charging rate or power to a second charging rate or power, lower than the first charging rate or power and (ii) notify a user of the ambulatory infusion pump regarding the reduction and the temperature value.
Paralikar teaches it was known in the art to have a system for recharging an implantable medical device including a first charging rate (“high” power level; parag. [0062]), a processor 30 (Fig.2) (processor) configured to obtain a temperature value (via temperature sensors; parag. [0027]) within an implantable medical device (IMD (14); Fig.1) and charge the IMD via the external charging device (22; Fig.1) at the first charging rate (“high” power level) (parag. [0062]), determine whether the temperature value meets or exceeds a threshold temperature (parag. [0062]), determine that the temperature value does not meet or exceed the threshold temperature causes the charging device to continue to transmit power to the pump at the at a “high” power level (parag. [0062]), and responsive to determining that the temperature valye meets or exceeds the threshold temperature causes the charging device to reduce the “high” power level to a “low” power level lower than the “high” power level (parag. [0062]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith to incorporate the teachings of Paralikar to obtain a temperature value within the ambulatory infusion pump while the battery is being charged at the first charging rate or power; determining whether the temperature value meets or exceeds a predetermined threshold corresponding to a particular temperature at which the medicament be negatively affected; responsive to determining that the temperature value does not meet or exceed the predetermined threshold, cause the inductive charging device to continue to transmit power to the ambulatory infusion pump at the first charging rate or power; and responsive to determining that the temperature value meets or exceeds the predetermined threshold, (i) cause the inductive charging device to reduce the first charging rate or power to a second charging rate or power, lower than the first charging rate or power in order to minimize the recharging time by transmitting power from a charging device to the medical device at a higher rate for a longer period of time during the recharging session while remaining in the temperature limits (parag. [0026]).
Nayak teaches it was known in the art to have an output device that notifies a user of a drug delivery device when a temperature of a medicament meets a threshold temperature via an audio, visual, or haptic output (lines 8-12 in column 10). Modifying Paralikar with the output device to notify the user when the temperature meets or exceeds the temperature threshold (from Nayak) would also notify the user regarding the reduction, since the charging rate in Paralikar is reduced when the temperature exceeds the threshold (parag. [0062])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith to incorporate the teachings of Nayak to notify a user of the ambulatory infusion pump regarding the reduction and the temperature value in order to alert the user when the medicine’s temperature meets the threshold (lines 8-12 in column 10).
Regarding Claim 31, Smith as modified discloses the ambulatory infusion pump system of claim 30, and Paralikar further teaches wherein the second charging rate or power (“low” power level) is a non-zero value (the “low” power level is less than the “high” power level (the “low” power level is minimal), and the “low” power level is non-zero (since the power source (18) will be charged at a lower rate)) (parag. [0062]).
Regarding Claim 32, Smith as modified discloses the ambulatory infusion pump system of claim 30, and Paralikar further teaches wherein the second charging rate or power (“low” power level) (parag. [0062]) is a zero value, such that charging the battery is suspended at the second charging rate or power (last sentence in parag. [0059]).
Regarding Claim 33, Smith as modified discloses the ambulatory infusion pump system of claim 30, and Paralikar further teaches wherein the first charging rate or power (“high” power level) is a maximum charging rate that the inductive charging device can provide (lines 4-6 in parag. [0063]).
Claims 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0184907), in view of Paralikar (US 2019/0190296), Nayak (US 11806516), and Labbe (US 2014/0070761).
Regarding Claim 34, Smith as modified discloses all the limitations of claim 20 above.
Smith does not appear to disclose prior to initiating charging, determining an initial temperature value within the ambulatory infusion pump and initiating charging responsive to determining that the initial temperature value does not meet or exceed the particular temperature at which the medicament can be negatively affected.
Labbe teaches it was known in the art to have a method for determining an initial temperature value (via temperature sensors) within an implantable medical device 10 (Fig.1) (parag. [0010]) before initiating charging of a rechargeable battery (via external charger 2) and only initiating charging if the temperature does not meet or exceed (below) the upper limit temperature (threshold) (parag. [0042]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith to incorporate the teachings of Labbe prior to initiating charging, determining an initial temperature value within the ambulatory infusion pump and initiating charging responsive to determining that the initial temperature value does not meet or exceed the particular temperature at which the medicament can be negatively affected in order to prevent undesirable temperature levels (avoid exceeding temperature limitations) on the medical device (parag. [0042]).
Regarding Claim 35, Smith as modified discloses the ambulatory infusion pump system of claim 34, and further discloses wherein the processor (237) is configured to provide a notification (alarm; parags. [0040] and [0093]) to a user. Labbe further teaches that charging has not been initiated responsive to determining that the initial temperature value meets or exceeds the particular temperature at which the medicament can be negatively affected (parag. [0042]).
Regarding Claim 36, Smith as modified discloses the ambulatory infusion pump of claim 30, and Labbe further teaches wherein the processor is further configured to prior to initiating charging, determine an initial temperature value within the ambulatory infusion pump (parag. [0010]), and initiate charging at the second charging rate or power (c/8) rather than the first charging rate or power (c/4) responsive to determining that the initial temperature value meets or exceeds the particular temperature at which the medicament can be negatively affected (parags. [0041]- [0042]) (Fig.5).
Regarding Claim 37, Smith as modified discloses all the limitations of claim 30 above.
Smith does not appear to disclose while charging the battery of the ambulatory infusion pump at the second charging rate or power, obtaining another temperature value within the ambulatory infusion pump; and increasing the charging rate or power to the first charging rate or power responsive to determining that the other temperature value does not meet or exceed the predetermined threshold.
Labbe teaches it was known in the art to have a method for recharging a battery in an implantable medical device and increasing the charging rate to a first charging rate (C/4; Fig.5) if the temperature does not meet or exceed (below) the threshold temperature while the inductive charging device is transmitting power at the second charging rate (C/8; Fig.5) (parag. [0039]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith to incorporate the teachings of Labbe to charge the battery of the ambulatory infusion pump at the second charging rate or power, obtaining another temperature value within the ambulatory infusion pump; and increasing the charging rate or power to the first charging rate or power responsive to determining that the other temperature value does not meet or exceed the predetermined threshold in order to prevent the level of heat within the device from reaching undesirable levels while maximizing the speed at which the device can be charged by maximizing the amount of time the device is charged at a high charge rate, since the lower charging rate increase charging times for medical devices (parag. [0008]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2012/0184907), in view of Paralikar (US 2019/0190296), Nayak (US 11806516), and Almendinger (US 2013/0238048).
Regarding Claim 38, Smith as modified discloses all the limitations of claim 30 above.
Smith does not appear to disclose obtain a rate of change of temperature within the ambulatory infusion pump while the battery is being charged at a first charging rate or power and control the inductive charging device to continue or reduce transmission of power to the ambulatory infusion pump based on the rate of change of temperature.
Almendinger teaches it was known in the art to have methods and systems for charging a battery of an implantable device by having a microprocessor for determining a rate of rise (rate of change) of temperature values (parag. [0014]). The external charger stop sending charge if the rate of temperature rise exceeds a predetermined maximum (second threshold level) (the microprocessor configured to determine if the rate of rise of the temperature or if the temperature exceeds a predetermined maximum as compared to the baseline, and configured to communicate to the external charger to stop sending charge or to change the power level of the charge if the rate of temperature rise exceeds a predetermined maximum or if the temperature exceeds a predetermined maximum; parag. [0014], lines 14-20).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Smith to incorporate the teachings of Almendinger to obtain a rate of change of temperature within the ambulatory infusion pump while the battery is being charged at a first charging rate or power and control the inductive charging device to continue or reduce transmission of power to the ambulatory infusion pump based on the rate of change of temperature in order to reach the allowable temperature very quickly and to achieve a lower rate of temperature rise to allow charging to proceed without exceeding temperature limit (parag. [0148]).
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.
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/T.I./Examiner, Art Unit 3783
/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783