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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed 11 December 2025. As directed by the amendment: claims 1-3, 5-10 and 21-30 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 11 December 2025 have been fully considered but they are not persuasive. Specifically, applicant argues for claim 7, Albertini does not teach informing the user of preservative loss because the alert only pertains to the insulin of the user. Albertini teaches an alert to inform the user of an issue with the insulin. This alert system can include a number of reasons for the insulin to have a problem including but not limited to preservative loss. Claim 7 does not specifically recite the preservative in the insulin as a separate feature of the device, but rather includes it as a condition for which an alert can be signaled. Albertini has an alert which can include spoiled insulin as a cause which can indicate that preservative loss has occurred among other problems (¶[0250] from Albertini). Applicant argues for claim 21 that Albertini does not teach reading a temperature value and comparing said value to the flow rate of the insulin. Albertini does teach that the temperature of the insulin settles at the environmental temperature as pointed out in paragraph 0255. This value is used in the lookup table as stated in paragraph 0275, therefore, the temperature of the drug is measured and included in the lookup table which includes flow rate. The processor of the device compares the values that come from the sensors of the device which mean in order to initiate operational change based on the look-up table (Albertini ¶[0170]).
Claim Rejections - 35 USC § 102
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.
Claims 7, 21-23, 25 and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Albertini et al. (henceforth “Albertini”, US 2022/0336076),
Regarding claim 7, Albertini discloses a user-wearable infusion pump system (Fig. 2, abstract), comprising:
a pump mechanism (Fig. 2, Fig. 5, 200) configured to deliver insulin to a user (¶[0096]); and
at least one processor (¶[0099], 296) configured to:
initiate delivery of insulin to a user with an insulin pump (¶[0100], where the actuation of the pump is controlled by the processor);
monitor a temperature in the insulin pump during delivery of the insulin (¶[0255], where the device can detect ambient temperature and in turn the drugs temperature inside the insulin pump);
monitor a flow rate of the insulin during delivery of the insulin (¶[0180], where a volumetric flow meter monitors flow rate);
compare the temperature and the flow rate to one or more thresholds (¶[0161], where the administration device compares measured parameters, which includes temperature and flow rate, to a predefined threshold value); and
selectively provide an alert to the user to implement a corrective action regarding the insulin if indicated by the comparison of the temperature and the flow rate to the one or more thresholds (¶[0159], [0192], [0271], where an alert can signal unsuccessful drug administration based on specified parameters, i.e. temperature or flow rate), wherein the alert informs the user of preservative loss in the insulin (¶[0159]-[0161], [0250], [0255], where the parameters have an indicator if a value is above or below set threshold levels such as temperature and flow rate. If the value of temperature exceeds an upper threshold and a flow rate is below an expected threshold the preservative loss can occur. The alert system will indicate both of these scenarios, the preservative loss indication would apply to these alerts as the thresholds are just higher temperature and lower flow rates, with no specific value that indicates that a preservative loss must have occurred, only likely values).
Regarding claim 21, Albertini discloses user-wearable infusion pump system, comprising:
a pump mechanism (Fig. 2, Fig. 5, 200) configured to deliver insulin to a user (¶[0096]); and
at least one processor (¶[0099], 296) configured to:
initiate delivery of insulin to a user with an insulin pump (¶[0100], where the actuation of the pump is controlled by the processor);
monitor a temperature in the insulin pump during delivery of the insulin (¶[0255], where the device can detect ambient temperature and in turn the drugs temperature inside the insulin pump);
monitor a flow rate of the insulin during delivery of the insulin (¶[0180], where a volumetric flow meter monitors flow rate);
compare values of the temperature with values of the flow rate and evaluate the relative values of the temperature and flow rate with respect to one or more thresholds (¶[0038], [0161], [0170], [0255], where the administration device compares measured parameters, which includes temperature and flow rate that are related to each other in that they are both parameters that are taken into account by the device and used in a lookup table, to a predefined threshold value); and
selectively provide an alert to the user to implement a corrective action regarding the insulin if indicated by the evaluation of the temperature and the flow rate to the one or more thresholds (¶[0159]-[0161], [0255], where the parameters have an indicator if a value is above or below set threshold levels such as temperature and flow rate. If the value of temperature exceeds an upper threshold and a flow rate is below an expected threshold the preservative loss can occur. The alert system will indicate both of these scenarios, the preservative loss indication would apply to these alerts as the thresholds are just higher temperature and lower flow rates, with no specific value that indicates that a preservative loss must have occurred, only likely values).
Regarding claim 22, Albertini discloses the system of claim 21, wherein the at least one processor is configured to compare the relative values of temperature and the flow rate to one or more thresholds using a lookup table (¶[0038], where received data can compare received data with a lookup table).
Regarding claim 23, Albertini discloses the system of claim 21, wherein the at least one processor is configured to compare current values of the temperature with values of the flow rate (¶[0038], [0045], [0159], where the sensors takes in continuous and current data for comparison to ideal parameters, where there are at least two sensors including a parameter sensor and temperature sensor).
Regarding claim 25, Albertini discloses the system of claim 21, wherein the alert informs the user of preservative loss in the insulin (¶[0161], where the parameters have an indicator if a value is above or below set threshold levels such as temperature and flow rate. If the value of temperature exceeds an upper threshold and a flow rate is below an expected threshold the preservative loss can occur. The alert system will indicate both of these scenarios).
Regarding claim 29, Albertini discloses the system of claim 7, wherein the at least one processor is configured to compare the temperature and the flow rate to one or more thresholds using a lookup table (¶[0161], where the administration device compares measured parameters, which includes temperature and flow rate, to a predefined threshold value and using a lookup table ¶[0038]);
Regarding claim 30, Albertini discloses the system of claim 29, wherein the lookup table compares values of temperature with values of flow rate (¶[0038], [0159]-[0161], [0250] [0255], where the administration device compares measured parameters, which includes temperature and flow rate that are related to each other in that they are both parameters that are taken into account by the device and used in a lookup table, to a predefined threshold value).
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 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Albertini et al. (henceforth “Albertini”, US 2022/0336076) in view of Gertner et al. (henceforth “Gertner”, US 5,707,641).
Regarding claim 1, Albertini discloses a user-wearable infusion pump system (Fig. 2, abstract), comprising:
a pump mechanism (Fig. 2, Fig. 5, 200) configured to deliver insulin to a user (¶[0096]); and
Albertini does not specifically describe “the insulin including a preservative therein”, however, the use of preservatives in insulin are well known in the art. Gertner describes using m-cresol as a preservative (Col. 8, lines 19-28). Jus the presence of a preservative would be obvious to one of ordinary skill in the art faced with the task of modifying the device of Albertini to have a longer lasting insulin compound as is well established in the art.
at least one processor (¶[0099], 296) configured to:
initiate delivery of insulin to a user with an insulin pump (¶[0100], where the actuation of the pump is controlled by the processor);
monitor a temperature in the insulin pump during delivery of the insulin (¶[0255], where the device can detect ambient temperature and in turn the drugs temperature inside the insulin pump);
monitor a flow rate of the insulin during delivery of the insulin (¶[0180], where a volumetric flow meter monitors flow rate);
compare the temperature and the flow rate to one or more thresholds (¶[0161], where the administration device compares measured parameters, which includes temperature and flow rate, to a predefined threshold value); and
selectively provide an alert to the user to implement a corrective action regarding the insulin if indicated by the comparison of the temperature and the flow rate to the one or more thresholds (¶[0159], [0192], [0250] [0271], where an alert can signal unsuccessful drug administration based on specified parameters, i.e. temperature or flow rate).
wherein the at least one processor is configured to provide the alert when relative values of the temperature and the flow rate indicate that a value of the preservative values in the insulin is likely to be below a predetermined threshold (¶[0161], where the threshold values are used to indicate if the parameters are above or below the predetermined threshold value, ¶[0159], [0192], [0250] where the alert uses parameter data to determine if an alert is necessary, the use of the word likely indicates that any number of reasons would indicate that a preservative is likely to have degraded or would not be in optimum condition).
Regarding claim 2, Albertini discloses the system of claim 1, wherein the at least one processor is configured to compare the temperature and the flow rate to one or more thresholds using a lookup table (¶[0038], where received data can compare received data with a lookup table).
Regarding claim 3, Albertini discloses the system of claim 2, wherein the lookup table compares values of temperature with values of flow rate (¶[0038], where the comparison of the received data is compared to the lookup table).
Regarding claim 5, Albertini discloses the system of claim 1, wherein the at least one processor is configured to compare current values of the temperature and the flow rate (¶[0045], [0159], where the sensors takes in continuous and current data for comparison to ideal parameters).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Albertini (US 2022/0336076) in view of Gertner et al. (US 5,707,641) as applied to claim 1 above, and further in view of Wiel et al. (henceforth “Wiel”, US 2024/0136135) and Nakamura (US 2024/0280391).
Regarding claim 6, Albertini does not specifically disclose wherein the at least one processor is configured to compare an average value of temperature and an average flow rate over a period of time.
Wiel discloses a medicament delivery device with sensors to determine termination or initiation during a pumping cycle (abstract). Wiel teaches sensing temperature readings that can be evaluated for a period of time to have an average that is compared to a threshold (¶[0081]). By taking the average of multiple reading for temperature, the device of Albertini would be improved by having a higher accuracy to determine if the device is functioning properly and going towards and optimized threshold value (¶[0081] from Wiel).
Nakamura discloses a flow-rate monitoring device with a processor and a computer-readable storage medium. Nakamura teaches a flow rate monitor that detects a flow rate and calculates an average value of the flow rates over a period of time (¶[0069]). By modifying the device of Albertini to include a calculation of average flow rates over time, it would improve the device to have an increased functionality in determining if an abnormality or errors occurred when pumping occurs through a wider range of values (¶[0069] from Nakamura).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Albertini to have an average value for temperature (¶[0081] from Wiel) and an average value for flow rate (¶[0069] from Nakamura) and compare those values over a period of times.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Albertini (US 2022/0336076) in view of Wiel et al. (henceforth “Wiel”, US 2024/0136135) and Nakamura (US 2024/0280391).
Regarding claim 24, Albertini discloses he system of claim 21, however, Albertini does not specifically disclose wherein the at least one processor is configured to compare an average value of temperature and an average flow rate over a period of time.
Wiel discloses a medicament delivery device with sensors to determine termination or initiation during a pumping cycle (abstract). Wiel teaches sensing temperature readings that can be evaluated for a period of time to have an average that is compared to a threshold (¶[0081]). By taking the average of multiple reading for temperature, the device of Albertini would be improved by having a higher accuracy to determine if the device is functioning properly and going towards and optimized threshold value (¶[0081] from Wiel).
Nakamura discloses a flow-rate monitoring device with a processor and a computer-readable storage medium. Nakamura teaches a flow rate monitor that detects a flow rate and calculates an average value of the flow rates over a period of time (¶[0069]). By modifying the device of Albertini to include a calculation of average flow rates over time, it would improve the device to have an increased functionality in determining if an abnormality or errors occurred when pumping occurs through a wider range of values (¶[0069] from Nakamura).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Albertini to have an average value for temperature (¶[0081] from Wiel) and an average value for flow rate (¶[0069] from Nakamura) and compare those values over a period of times.
Claim(s) 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Albertini (US 2022/0336076) in view of Lim et al. (henceforth “Lim”, US 2024/0062867).
Regarding claim 26, Albertini discloses he system of claim 21, however, Albertini does not specifically disclose wherein the alert instructs the user to replace the insulin as the corrective action.
Lim discloses a medicament delivery device that includes and insulin cartridge and pumping system. Lim teaches an alarm that alerts a user to replace an insulin cartridge (¶[0376]). Replacing the insulin cartridge with a new cartridge with insulin is necessarily the same as replacing the insulin as a corrective action. By modifying the device of Albertini to include an alarm system that addresses and alarm condition and instructs a user to replace the insulin it would improve the functionality of the device by preventing the user from operating the pump with defective medicament or delivery (¶[0370], [0376] from Lim). The device of Albertini already has the capability to modify, clean or replace parts of the device.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Albertini to have an alarm to instruct a user to replace the insulin of the device (¶[0376] from Lim).
Regarding claim 27, Albertini as modified by Lim discloses the system of claim 26, wherein the alert instructs the user to replace the insulin in a user-wearable infusion pump (¶[0376] from Lim).
Regarding claim 28, Albertini as modified by Lim disclose the system of claim 27, wherein the alert instructs the user to dispose of an insulin cartridge of the user-wearable infusion pump and to replace the insulin cartridge with a new insulin cartridge (¶[0376] from Lim).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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