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
This office action is responsive to the amendment filed 29 June 2026. 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(s) 1-3, 5 and 7 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 29 June 2026 have been fully considered but they are not persuasive.
Regarding claim 21 and its dependent claims, the device of Albertini teaches reading these values. As stated in the 35 USC 101 rejection, the processor does not have to do anything with these values as relative temperature and flow rate can be monitored and then compared by hand without any extra steps. The device of Albertini having these values at all is sufficient for comparison as it is possible to look at the two readings side by side and compare them with each other and also compare them to a threshold that relates to both values.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5-10, and 21-30 rejected under 35 U.S.C. 101 because the claimed invention lacks patentable utility. Specifically in claim 1, the device as presented uses a processor that does not cause delivery of insulin but rather initiates delivery. This can be performed by simply turning on the computer device, however, there is no direct step that insulin delivery occurs by having a part of the process be handled by the processor. This is simply turning on the computer device and the following steps are additional elements or extra solution activity related to the processor. The monitoring steps can be performed by simple observation and do not require the processor do anything. The comparison of the values can be done by hand by a user looking at a table of values for temperature and flow rate. The determination step is comparing said values to a threshold which is not set by the computer and the expected value of the preservative can also be a hypothetical value that can be predetermined by hand using the assumed thresholds as well as the values of temperature and flow rate. The alert that is provided is simply a display or notification of no specific nature to do something with the insulin, however, there is no step regarding what needs to be done or what is done. The claim can be improved by stating that the pump in the device actually delivers the insulin in specifically stated manner. This step can occur early in the step process to state that the processor is actually performing a step that relates to the pump activity. Claims 7 and 21 also require the processor and do not have a step that requires the processor do anything to delivery the insulin in the pump. Claims 2-3, 5-10 and 22-30 depend on claims 1, 7 and 21 respectively and are therefore rejected similarly.
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 21-23 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 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 the 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
determine that the user should implement a corrective action regarding the insulin based on the evaluation of the relative values of the temperature and the flow rate with respect to the one or more thresholds;
provide an alert to the user to implement the corrective action regarding the insulin (¶[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 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.
Claim(s) 1-3, 5, 7, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Albertini et al. (henceforth “Albertini”, US 2022/0336076) in view of Chattaraj et al. (henceforth “Chattaraj”, US 2011/0152820) and Alarcon et al. (henceforth “Alarcon”, US 2013/0296235).
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
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
Albertini does not specifically teach preservatives in the insulin, but does teach the insulin can be replaced for a number of factors.
Chattaraj teaches that insulin can drop below certain levels if not stored properly. It is known in the art that preservative loss can occur based on temperature at least (¶[0025]). The change in preservative levels is not something that is directly measured, however, external factors are known to cause a change in preservative levels and those can be measured and tested. This knowledge would be common for a device such as Albertini and would improve the device by simply acknowledging the replacement of the insulin could be related to the preservative in the insulin.
Alarcon also teaches that flow is a factor which can inhibit preservative loss. In paragraph 0037, Alacorn states that the flow path of the delivery device is designed such that the preservative loss is inhibited during the delivery process. This is another example as to what is known in the art regarding preservatives.
Combining both the teachings of Chattaraj and Alarcon with Albertini would improve the device as it gives the context that preservatives are present in the insulin, and the insulin being spoiled or unusable can occur from preservative loss under certain conditions.
The value of the preservative being and expected value compared to a predetermined threshold means that device of Albertini does have enough data to predict a hypothetical number with regards to a temperature and flow rate reading. This value can indicate that preservative loss has occurred but is not a specific measurement that needs to be taken by the device.
This combination then teaches:
determine from the comparison of the temperature and flow rate to the one or more thresholds that an expected value of the preservative is below a predetermined threshold (¶[0255], where the device can detect ambient temperature and in turn the drugs temperature inside the insulin pump and ¶[0180], where a volumetric flow meter monitors flow rate, these values are can be compared to any value that is predetermined and based on this, find the hypothetical value of the preservative and compare that another predetermined threshold value)
provide an alert to the user to implement a corrective action regarding the insulin upon determining that the expected value of the preservative is below the predetermined threshold (¶[0159], [0192], [0250] [0271], where an alert can signal unsuccessful drug administration based on specified parameters, i.e. temperature or flow rate which are factors in preservative loss, this alert is a display of some possible problem which can include but is not limited to insulin degrading).
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 which can be done by looking at the two values).
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).
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
Albertini does not specifically teach preservatives in the insulin, but does teach the insulin can be replaced for a number of factors.
Chattaraj teaches that insulin can drop below certain levels if not stored properly. It is known in the art that preservative loss can occur based on temperature at least (¶[0025]). The change in preservative levels is not something that is directly measured, however, external factors are known to cause a change in preservative levels and those can be measured and tested. This knowledge would be common for a device such as Albertini and would improve the device by simply acknowledging the replacement of the insulin could be related to the preservative in the insulin.
Alarcon also teaches that flow is a factor which can inhibit preservative loss. In paragraph 0037, Alacorn states that the flow path of the delivery device is designed such that the preservative loss is inhibited during the delivery process. This is another example as to what is known in the art regarding preservatives.
Combining both the teachings of Chattaraj and Alarcon with Albertini would improve the device as it gives the context that preservatives are present in the insulin, and the insulin being spoiled or unusable can occur from preservative loss under certain conditions.
The value of the preservative being and expected value compared to a predetermined threshold means that device of Albertini does have enough data to predict a hypothetical number with regards to a temperature and flow rate reading. This value can indicate that preservative loss has occurred but is not a specific measurement that needs to be taken by the device.
This combination then teaches:
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 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).
Albertini does not specifically teach preservatives in the insulin, but does teach the insulin can be replaced for a number of factors.
Chattaraj teaches that insulin can drop below certain levels if not stored properly. It is known in the art that preservative loss can occur based on temperature at least (¶[0025]). The change in preservative levels is not something that is directly measured, however, external factors are known to cause a change in preservative levels and those can be measured and tested. This knowledge would be common for a device such as Albertini and would improve the device by simply acknowledging the replacement of the insulin could be related to the preservative in the insulin.
Alarcon also teaches that flow is a factor which can inhibit preservative loss. In paragraph 0037, Alacorn states that the flow path of the delivery device is designed such that the preservative loss is inhibited during the delivery process. This is another example as to what is known in the art regarding preservatives.
Combining both the teachings of Chattaraj and Alarcon with Albertini would improve the device as it gives the context that preservatives are present in the insulin, and the insulin being spoiled or unusable can occur from preservative loss under certain conditions.
The value of the preservative being and expected value compared to a predetermined threshold means that device of Albertini does have enough data to predict a hypothetical number with regards to a temperature and flow rate reading. This value can indicate that preservative loss has occurred but is not a specific measurement that needs to be taken by the device.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Albertini (US 2022/0336076) in view of Chattaraj et al. (henceforth “Chattaraj”, US 2011/0152820) and Alarcon et al. (henceforth “Alarcon”, US 2013/0296235) 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.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Albertini et al. (henceforth “Albertini”, US 2022/0336076) in view of Chattaraj et al. (henceforth “Chattaraj”, US 2011/0152820) and Alarcon et al. (henceforth “Alarcon”, US 2013/0296235) as applied to claim 7 above, and further in view of Lim et al. (henceforth “Lim”, US 2024/0062867).
Regarding claim 8, 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 9, Albertini as modified by Lim discloses the system of claim 8, wherein the alert instructs the user to replace the insulin in a user-wearable infusion pump (¶[0376] from Lim).
Regarding claim 10, Albertini as modified by Lim disclose the system of claim 9, 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).
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
/JASON E FLICK/Primary Examiner, Art Unit 3783 08/23/2026
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