Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
1. This action is responsive to the reply filed on March 16, 2026.
2. Claims 21-27 and 29-42 have been examined.
Response to Amendment
3. In good faith, Examiner proposed allowable subject matter in the non-final action mailed on October 16, 2025. However, in the amendment filed March 16, 2026, Applicant removed several critical limitations in independent claims.
On May 4, 2026, Examiner contacted Applicant to propose allowable subject matter. No reply was received.
4. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action.
Allowable Subject Matter
5. After search and analysis, Examiner concluded that the claimed invention has been recited in such a manner that dependent claim 26 is not taught by any prior reference found through search.
The primary reason for allowance of the claims in this case, is the inclusion of the limitations “The method of claim 21, wherein verifying the safe condition for the update comprises verifying one or more of: the ambulatory infusion pump is not currently administering a medicament; the ambulatory infusion pump is not attached to a patient; and a medicament reservoir of the ambulatory infusion pump is not in fluid communication with the patient,” which are not found in the prior art of record.
Incorporating claim 26 into claims 21 and 34 would put the case in condition for allowance.
Claim 38 is similar to claim 26 and also allowable.
6. After search and analysis, Examiner concluded that the claimed invention has been recited in such a manner that dependent claim 27 is not taught by any prior reference found through search.
The primary reason for allowance of the claims in this case, is the inclusion of the limitations “The method of claim 21, wherein verifying the safe condition for the update includes verifying that the ambulatory infusion pump is not able to accidentally deliver unintentional amounts of a medicament to the patient,” which are not found in the prior art of record.
Incorporating claim 27 into claims 21 and 34 would put the case in condition for allowance.
7. After search and analysis, Examiner concluded that the claimed invention has been recited in such a manner that dependent claim 31 is not taught by any prior reference found through search.
The primary reason for allowance of the claims in this case, is the inclusion of the limitations “The method of claim 21, further comprising verifying compatibility of the remote control device with the update by verifying a memory capacity of the remote control device and confirming that a device model of the remote control device is compatible with the update,” which are not found in the prior art of record.
Incorporating claim 31 into claims 21 and 34 would put the case in condition for allowance.
Claim 41 is similar to claim 31 and also allowable.
Double Patenting Rejection
8. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131 (c). A registered attorney or agent of record may sign a terminal disclaimer.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/ file/efs/guidance/eTD-info-l.jsp.
Claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 9,895,491, 11,049,614, and 11,776,689. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the present application are just broader versions of the patent claims.
US Patent 9,895,491
Present Application
6. A system for remotely updating software operating on an ambulatory fluid delivery device, comprising: an ambulatory fluid delivery device; and a computing system having a hardware processor configured to remotely update software operating on the ambulatory fluid delivery device, wherein upon determining that a software update is available for the ambulatory fluid delivery device the hardware processor of the computing system is programmed to: interrogate the ambulatory fluid delivery device to obtain data from the ambulatory fluid delivery device, the data including a patient basal medication dosage profile and device history logs; verify that the ambulatory fluid delivery device is compatible with a software update, including both verifying a memory capacity of the ambulatory fluid delivery device and confirming that a model of the ambulatory fluid delivery device is compatible with the software update; verify that a user of the ambulatory fluid delivery device wishes to update software on the ambulatory fluid delivery device; send the software update to the ambulatory fluid delivery device; verify that the ambulatory fluid delivery device is in a safe condition for the software update, including verifying an absence of error messages within a certain time period in the device history logs; receive confirmation that the software update has occurred on the ambulatory fluid delivery device; and verify that the ambulatory fluid delivery device is in a safe condition to perform as intended after the software update.
Claim 10.
The system of claim 6, where a safe condition for the software update comprises one or more of: the ambulatory fluid delivery device not currently administering a medicament, the ambulatory fluid delivery device not being attached to a patient, and a liquid medicament repository not being in fluid communication with the patient.
6. The method of claim 1, where a safe condition for the software update comprises one or more of: the ambulatory infusion pump not currently administering a medicament, the ambulatory infusion pump not being attached to a patient, and a medicament reservoir of the ambulatory infusion pump not being in fluid communication with the patient.
11. The system of claim 6, wherein verifying that the ambulatory fluid delivery device is in a safe condition to perform as intended after the software update comprises one or more of: verifying an ability of the ambulatory fluid delivery device to dispense one or more medicaments; verifying an ability of the ambulatory fluid delivery device to update a device history log; and verifying an ability of the ambulatory fluid delivery device to accept sensor data to influence medicament dosing.
21. A method of updating a remote control device configured to control an ambulatory infusion pump, comprising: determining that an update is available for the remote control device; verifying that a safe condition for the update; proceeding with the update to the remote control device after verifying the safe condition; and receiving information verifying that the remote control device is able to safely operate the ambulatory infusion pump after the update, the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
34. A method of updating a remote control device configured to control an ambulatory infusion pump, comprising: transmitting information verifying that a safe condition exists for performing an update on the remote control device; receiving the update in response to transmitting the information verifying the safe condition; installing the update on the remote control device after verifying the safe condition; and transmitting information verifying that the remote control device is able to safely operate the ambulatory infusion pump after the update, the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
US Patent 11,049,614
Present Application
1. A method performed by software executable instructions on a hardware processor for remotely updating software on a remote control device configured to remotely control operations of an ambulatory infusion pump, comprising: receiving, at a central computing system, a request from the remote control device configured to remotely control operations of the ambulatory infusion pump for a software update; determining that the software update is available for the remote control device; confirming an active wireless connection between the central computing system and the remote control device; automatically wirelessly transmitting the software update from the central computing system to the remote control device when the software update is available; verifying that a safe condition for the software update exists; verifying that a user wishes to proceed with the software update transmitted to the remote control device; installing the software update on the remote control device if a safe condition for the software update exists and the user verifies that the user wishes to proceed with the software update; and notifying the user on the remote control device that the software update is occurring.
7. The method of claim 1, where a safe condition for the software update comprises the ambulatory infusion pump not being able to accidentally deliver unintentional amounts of the medicament to the patient.
8. The method of claim 1, further comprising verifying a safe condition exists for operation of the ambulatory infusion pump by the remote control device after the software update comprising one or more of: verifying an ability of the ambulatory infusion pump to dispense one or more medicaments; verifying an ability of the ambulatory infusion pump to update a device history log; and verifying an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
14. A method for remotely updating software on a remote control device configured to remotely control operations of an ambulatory infusion pump, comprising: transmitting a request for a software update to a central computer system; automatically wirelessly receiving the software update from the central computer system when the software update is available; verifying that a safe condition for the software update exists; verifying that a user wishes to proceed with the software update; installing the software update on the remote control device configured to remotely control operations of the ambulatory infusion pump if a safe condition for the software update exists and the user verifies that the user wishes to proceed with the software update; and notifying the user on the remote control device that the software update is occurring; and transmitting information for verifying that a safe condition exists for operation of the ambulatory infusion pump by the remote control device after the software update.
21. A method of updating a remote control device configured to control an ambulatory infusion pump, comprising: determining that an update is available for the remote control device; verifying that a safe condition for the update; proceeding with the update to the remote control device after verifying the safe condition; and receiving information verifying that the remote control device is able to safely operate the ambulatory infusion pump after the update, the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
34. A method of updating a remote control device configured to control an ambulatory infusion pump, comprising: transmitting information verifying that a safe condition exists for performing an update on the remote control device; receiving the update in response to transmitting the information verifying the safe condition; installing the update on the remote control device after verifying the safe condition; and transmitting information verifying that the remote control device is able to safely operate the ambulatory infusion pump after the update, the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
US Patent 11,776,689
Present Application
1. A method of remotely updating software on a remote control device configured to remotely control operations of an ambulatory infusion pump, comprising: determining whether a software update is available for a remote control device configured to remotely control operations of an ambulatory infusion pump; confirming an active wireless connection with the remote control device; verifying that a safe condition for the software update exists; automatically wirelessly transmitting the software update to the remote control device if a safe condition for the software update exists; verifying that a user wishes to proceed with the software update; and enabling the software update to be installed on the remote control device if the user verifies that the user wishes to proceed with the software update.
6. The method of claim 1, wherein verifying that a safe condition for the software update exists comprises verifying one or more of: the ambulatory infusion pump is not currently administering a medicament, the ambulatory infusion pump is not attached to a patient, and a medicament reservoir of the ambulatory infusion pump is not in fluid communication with the patient.
7. The method of claim 1, wherein verifying that a safe condition for the software update exists includes verifying that the ambulatory infusion pump is not able to accidentally deliver unintentional amounts of a medicament to the patient.
8. The method of claim 1, further comprising verifying that a safe condition exists for operation of the ambulatory infusion pump by the remote control device after the software update comprising one or more of: verifying an ability of the ambulatory infusion pump to dispense one or more medicaments; verifying an ability of the ambulatory infusion pump to update a device history log; and verifying an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
14. A method of remotely updating software on a remote control device configured to remotely control operations of an ambulatory infusion pump, comprising: transmitting information verifying that a safe condition exists for performing a software update on a remote control device configured to remotely control operations of an ambulatory infusion pump; automatically wirelessly receiving the software update device if a safe condition for the software update exists; verifying that a user wishes to proceed with the software update; installing the software update on the remote control device if the user verifies that the user wishes to proceed with the software update; notifying the user that the software update is occurring; and transmitting information for verifying that a safe condition exists for operation of the ambulatory infusion pump by the remote control device after the software update.
18. The method of claim 14, wherein transmitting information verifying that a safe condition for the software update exists comprises transmitting information verifying one or more of: the ambulatory infusion pump is not currently administering a medicament, the ambulatory infusion pump is not attached to a patient, and a medicament reservoir of the ambulatory infusion pump is not in fluid communication with the patient.
23. The method of claim 14, further comprising transmitting information verifying compatibility of the remote control device with the software update including transmitting information verifying a memory capacity of the remote control device and transmitting information verifying that a device model of the remote control device is compatible with the software update.
21. A method of updating a remote control device configured to control an ambulatory infusion pump, comprising: determining that an update is available for the remote control device; verifying that a safe condition for the update; proceeding with the update to the remote control device after verifying the safe condition; and receiving information verifying that the remote control device is able to safely operate the ambulatory infusion pump after the update, the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
34. A method of updating a remote control device configured to control an ambulatory infusion pump, comprising: transmitting information verifying that a safe condition exists for performing an update on the remote control device; receiving the update in response to transmitting the information verifying the safe condition; installing the update on the remote control device after verifying the safe condition; and transmitting information verifying that the remote control device is able to safely operate the ambulatory infusion pump after the update, the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
Claim Rejections – 35 USC §103
9. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
10. Claims 21, 22, 24, 25, 29, 32-35, 37, 39, and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over 2012/0096451 to Tenbarge et al. (hereafter “Tenbarge”) in view of US 2015/0335902 to Delisle (hereafter "Delisle") and further in view of US 2014/0142535 to Imhof et al. (hereafter "Imhof").
Claim 21.
Tenbarge discloses a method of updating a remote control device configured to control an ambulatory infusion pump, comprising:
determining that an update is available for the remote control device (0077, 0080, 0108);
verifying that a safe condition for the update (0041, 0067, 0106);
proceeding with the update to the remote control device after verifying the safe condition (FIG.3, 0044, 0120, 0125, updating firmware of Handheld Diabetes Management Device 104)
receiving information verifying that the remote control device is able to operate the ambulatory infusion pump after the update (0098).
Tenbarge discloses self-tests but does not disclose self-tests to safely operate.
However, Delisle discloses self-tests to safely operate (0003).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Delisle’s teaching into Tenbarge‘s teaching. One would have been motivated to do so to verify operations are within predetermined specifications as suggested by Delisle (0003).
Tenbarge and Delisle do not disclose the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
However, Imhof discloses the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing (0050).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Imhof’s teaching into Tenbarge and Delisle‘s teaching. One would have been motivated to do so to reveal any problems with starting insulin delivery as suggested by Imhof (0050).
Claim 22.
Tenbarge discloses the method of claim 21, wherein the remote control device is a portable computing device (FIG.3, Handheld Diabetes Management Device 104 and related text).
Claim 24.
Tenbarge discloses the method of claim 21, wherein the remote control device is a dedicated handheld remote control (FIG.3, Handheld Diabetes Management Device 104 and related text).
Claim 25.
Tenbarge discloses the method of claim 21, wherein verifying the safe condition includes receiving a verification of the safe condition from the remote control device (0041, 0067, 0106, receiving a verification of safe battery level from the Handheld Diabetes Management Device 104).
Claim 29.
Tenbarge discloses the method of claim 21, wherein verifying the safe condition for the update further comprises receiving information confirming an absence of error messages relating to operation of the ambulatory infusion pump (0104, 0105, 0110, 0113).
Claim 32.
Tenbarge discloses the method of claim 21, further comprising receiving information verifying that the ambulatory infusion pump performs as intended after the update (FIG.6E, blocks 936, 940, 944, 956, and related text).
Claim 33.
Tenbarge discloses the method of claim 21, further comprising receiving information that a battery of the remote control device has a requisite level of charge prior to installing the update (0041, 0067, 0106).
Claim 34.
Tenbarge discloses a method of updating a remote control device configured to control an ambulatory infusion pump, comprising:
transmitting information verifying that a safe condition exists for performing an update on the remote control device (0104, 0105, 0110, 0113);
receiving the update in response to transmitting the information verifying the safe condition (0041, 0067, 0106);
installing the update on the remote control device after verifying the safe condition (FIG.3, 0044, 0120, 0125, updating firmware of Handheld Diabetes Management Device 104); and
transmitting information verifying that the remote control device is able to operate the ambulatory infusion pump after the update (0098).
Tenbarge discloses self-tests but does not disclose self-tests to safely operate.
However, Delisle discloses self-tests to safely operate (0003).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Delisle’s teaching into Tenbarge‘s teaching. One would have been motivated to do so to verify operations are within predetermined specifications as suggested by Delisle (0003).
Tenbarge and Delisle do not disclose the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing.
However, Imhof discloses the information comprising verification of one or more of: an ability of the ambulatory infusion pump to dispense one or more medicaments, an ability of the ambulatory infusion pump to update a device history log, and an ability of the ambulatory infusion pump to accept sensor data to influence medicament dosing (0050).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Imhof’s teaching into Tenbarge and Delisle‘s teaching. One would have been motivated to do so to reveal any problems with starting insulin delivery as suggested by Imhof (0050).
Claim 35.
Tenbarge discloses the method of claim 34, wherein the remote control device is a portable computing device (FIG.3, Handheld Diabetes Management Device 104 and related text).
Claim 37.
Tenbarge discloses the method of claim 34, wherein the remote control device is a dedicated handheld remote control (FIG.3, Handheld Diabetes Management Device 104 and related text).
Claim 39.
Tenbarge discloses the method of claim 34, wherein the information verifying the safe condition includes an indication of an absence of error messages relating to operation of the ambulatory infusion pump (0104, 0105, 0110, 0113).
Claim 42.
Tenbarge discloses the method of claim 34, further comprising transmitting information verifying that the ambulatory infusion pump performs as intended after the update (FIG.6E, blocks 936, 940, 944, 956, and related text).
11. Claims 23 and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tenbarge, in view of Delisle, Imhof, and further in view of US 2011/0217205 to Peeters (hereafter “Peeters”).
Claim 23.
Tenbarge, Delisle, and Imhof do not disclose the method of claim 21, wherein the remote control device is cell phone.
However, Peeters further discloses the remote control device is cell phone (0058).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Peeters’ teaching into Tenbarge, Delisle, and Imhof‘s teaching. One would have been motivated to do so to control a implanted insulin pump via RF as suggested by Peeters (0058).
Claim 36.
This claim is a method version, which recites the same limitations as those of claim 23, wherein all claimed limitations have been addressed and/or set forth above. Therefore, as the reference teaches all of the limitations of the above claim, it also teaches all of the limitations of this claim.
12. Claims 30 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tenbarge, in view of Delisle, Imhof, and further in view of US 2013/0104120 to Arrizza et al. (hereafter “Arrizza”).
Claim 30.
Tenbarge, Delisle, and Imhof do not disclose the method of claim 21, further comprising receiving a user input from the remote control device, wherein the user input comprises an indication that the use wishes to proceed with the update.
However, Arrizza further discloses receiving a user input from the remote control device, wherein the user input comprises an indication that the use wishes to proceed with the update (0040, 0054, 0072).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Arrizza’s teaching into Tenbarge, Delisle, and Imhof‘s teaching. One would have been motivated to do so to provide the nurse/patient a chance to reject the update as suggested by Arrizza (0040).
Claim 40.
Tenbarge, Delisle, and Imhof do not disclose the method of claim 34, further comprising verifying that a user wishes to proceed with the update by receiving user input accepting a message pertaining to the update.
However, Arrizza further discloses verifying that a user wishes to proceed with the update by receiving user input accepting a message pertaining to the update (0040, 0054, 0072).
It would have been obvious to a person having ordinary skill in the art at the time the invention was made to combine Arrizza’s teaching into Tenbarge, Delisle, and Imhof‘s teaching. One would have been motivated to do so to provide the nurse/patient a chance to reject the update as suggested by Arrizza (0040).
Conclusion
13. Applicants' 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 extension fee 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 date of this final action.
14. . Any inquiry concerning this communication should be directed to examiner Thuy (Twee) Dao, whose telephone/fax numbers are (571) 272 8570 and (571) 273 8570, respectively. Examiner can normally be reached from Monday to Friday, 5:30am - 2:00pm ET.
If attempts to reach Examiner by telephone are unsuccessful, Examiner’s supervisor, Hyung (Sam) Sough, can be reached at (571) 272 6799.
The fax phone number for the organization where this application or proceeding is assigned is (571) 273 8300.
Any inquiry of a general nature of relating to the status of this application or proceeding should be directed to the TC 2100 Group receptionist whose telephone number is (571) 272 2100.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Thuy Dao/Primary Examiner, Art Unit 2197
Prosecution Insights