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 Amendments
The Amendment filed 11/24/2025 has been entered.
Claims 1-11, 13-16, and 21 are cancelled.
Claims 12, 17-20, and 22-40 remain pending in the application.
Election/Restrictions
Claims 12, 17-20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/24/2025.
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.
Claim 30 is 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.
Claim 30 recites the limitation “the injection pen” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23, 25, 26, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Lanigan et al. (U.S. Patent Pub. 20100198182), hereinafter Lanigan, further in view of Lee et al. (U.S. Patent Pub. 20210098105), hereinafter Lee.
Regarding claim 23, Lanigan discloses an insulin delivery and data collection system (charging station 2900, see FIG. 205; the Examiner notes that all reference characters cited below refer to FIG. 205 unless otherwise stated), comprising:
at least one insulin delivery device (disposable assembly 2908);
a weighing system (weight scale 2906) attached to a longitudinal end of the insulin delivery device (see FIG. 205), the weighing system comprising:
at least one load cell disposed at a bottom of at least one cavity (scale portion 2922; “The weight scale 2906 in some embodiments may be sized to accommodate a disposable assembly 2908.”, [0959]; the Examiner notes the internal cavity of station of 2900); and
a control system (electrical control assembly 110, see [0178]) comprising:
at least one processor (“electrical control assembly 110 may include two separate and distinct microprocessors”, [0728]); “In some embodiments, a processor may calculate the weight of the fluid filled and correlate the weight to a volume of fluid”, [0956]).
However, Lanigan does not expressly state at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control system to receive weight data from the at least one load cell related to the at least one insulin delivery device.
Lee teaches a device, a computer-readable medium, and techniques that provide an onboarding process and an adaptivity process for a drug delivery device (Abstract) at least one non-transitory computer-readable storage medium (see [0123]) storing instructions thereon that, when executed by the at least one processor, cause the control system to receive weight data from the at least one load cell related to the at least one insulin delivery device (“non-transitory computer readable medium that is embodied with programming code executable by a processor is disclosed. The processor when executing the programming code is operable to perform functions, including functions to retrieve a portion of an insulin delivery history related to a user”, [0004]; see weighted sum in [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Lanigan to include at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control system to receive weight data from the at least one load cell related to the at least one insulin delivery device. Doing so would allow for selection of safety boundaries and limitations regarding the amount of insulin to be delivered, as taught by Lee (see [0004; 0040]).
Regarding claim 25, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 23, and Lanigan further teaches comprising at least one charging element (the Examiner notes charger portion 2924 has charging section 2904 which can be in FIG. 205 being disposed within station 2900) disposed within the at least one cavity.
Regarding claim 26, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 25, and Lanigan further teaches wherein the at least one charging element comprises at least one USB plug (“ Desktop charger 1250 may also include USB port 1258 (e.g., which may include a mini-USB port), allowing desktop charger to receive power (e.g., for charging the reusable housing assembly and/or the remote control assembly). Additionally/alternatively USB port 1258 may be configured for data transfer to/from remote control assembly and/or reusable housing assembly, e.g., by connection to a computer (not shown).” [0473]; “According to one embodiment, charger 2600 may utilize a mini-USB connection, e.g., which may provide power to charger 2600 as well as allowing data communication, e.g., between charger 2600 and an external computer”, [0490]).
Regarding claim 29, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 23, and Lanigan further teaches wherein the at least one load cell comprises a strain gauge load cell (“a strain gauge may be connected to the diaphragm (not shown) or other structural member supporting the resonant mass (not shown)”, [0690]).
Regarding claim 31, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 23, and Lee further teaches comprising instructions that, when executed by the at least one processor, cause the control system to wirelessly transmit the weight data to one or more of a cloud computing platform or a client device (“The smart phone may either store the new data collected or previously collected data or may be able to access a remote server, such as a cloud based server.”, [0097]; “In addition, the wearable drug delivery device 702 may be operable to communicate with the cloud-based services 711 via the communication device 726 and the communication link 788.”, [0107]; see [0118-0119]).
Claims 24, 27, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Lanigan et al. (U.S. Patent Pub. 20100198182), hereinafter Lanigan, further in view of Lee et al. (U.S. Patent Pub. 20210098105), hereinafter Lee, further in view of Shaanan et al. (U.S. Patent Pub. 20120330556), hereinafter Shaanan.
Regarding claim 24, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 23, and Lanigan further teaches further comprising instructions that, when executed by the at least one processor (see processors of [0495]), cause the control system to:
monitor a charge level of a power source (“The battery charging circuit may, for example, monitor battery voltage and temperature (e.g., via information provided by the battery thermister via the six contact electrical connector).”, [0494]) of the at least one insulin delivery device (“infusion pump assembly 800. As with infusion pump assemblies 100, 100', 400, and 500, infusion pump assembly 800 may include reusable housing assembly 802”, [0398]); however, Lanigan in view of Lee does not expressly state acquiring a charge level of the power source of the at least one insulin delivery device responsive to insertion of the at least one insulin delivery device into the at least one cavity.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) comprising instructions that, when executed by the at least one processor (see processor in [0037-0038]) acquire a charge level of the power source (see [0014;0035]) of the at least one insulin delivery device (insulin pen, see [0011]) responsive to insertion of the at least one insulin delivery device into the at least one cavity (“Docking station 300 can optionally be configured with a cradle or recessed portion for receiving device 200 in a secure manner.”, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Lanigan in view of Lee to include instructions that, when executed by the at least one processor acquire a charge level of the power source of the at least one insulin delivery device responsive to insertion of the at least one insulin delivery device into the at least one cavity. Doing so would indicating a charge status and data exchange status, helping the user to determine whether results are within acceptable limits, as taught by Shaanan (see [0014]).
Regarding claim 27, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 25, however, Lanigan in view of Lee does not expressly state wherein the at least one charging element comprises at least one inductive charging plate or coil.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) wherein the at least one charging element comprises at least one inductive charging plate or coil (“Power interface 310 is an inductive pad configured to provide electrical power to a rechargeable battery within device 200. An inductive pad advantageously allows device 200 to charge without physically mating with the docking station. In alternative embodiments, power interface 310 could comprise an electrical connector configured to mate with a connector on device 200.”, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Lanigan in view of Lee to include wherein the at least one charging element comprises at least one inductive charging plate or coil. Doing so provides wireless recharging capabilities, as taught by Shaanan (see [0030]).
Regarding claim 28, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 25, and Lanigan further discloses comprising instructions that, when executed by the at least one processor, cause the control system to transfer data to or receive data from the at least one insulin delivery device(“Electrical control assembly 110 may monitor and control the amount of infusible fluid that has been and/or is being pumped.”, [0178]) however, Lanigan in view of Lee does not expressly state the transfer through the at least one charging element.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) further comprising instructions that, when executed by the at least one processor, cause the control system to transfer data to or receive data from the at least one insulin delivery device, through the at least one charging element (“] In one aspect of preferred embodiments, the testing device and/or the docking station has a communication facility configured to transmit and receive with an external storage device (e.g., a medical provider server, home computer, local area network). The communication facility can be wired or wireless. In preferred embodiments, the communication facility uses at least two wireless protocols. In other preferred embodiments, the communication facility transmits data a cell phone network. Contemplated data include test data, information derived from test data, and non-test data… In some aspects of preferred embodiments, the power interface is an inductive charging pad and the data interface is a wired connection, such as a USB port. The docking station can further include a second data interface, either wired or wireless, for exchanging data with an external device (e.g., home computer, laptop, smart phone, insulin pen, health test device).”, [0010-0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Lanigan in view of Lee to include comprising instructions that, when executed by the at least one processor, cause the control system to transfer data to or receive data from the at least one insulin delivery device through the at least one charging element. Doing so provides wireless recharging capabilities and wireless data exchange, as taught by Shaanan (see [0010-0011]).
Regarding claim 30, Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 23, however, Lanigan in view of Lee does not expressly state wherein the at least one cavity is configured to receive the injection pen.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) wherein the at least one cavity is configured to receive the injection pen (see [0020; 0051-0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Lanigan in view of Lee to include wherein the at least one cavity is configured to receive the injection pen. Doing so provides an external device for the docking station to transmit data too, as taught by Shaanan (see [0051-0052]).
Claims 32, 34, 35, 38, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Juselius et al. (U.S. Patent Pub. 20020096543), hereinafter Juselius, further in view of Lanigan et al. (U.S. Patent Pub. 20100198182), hereinafter Lanigan, further in view of Lee et al. (U.S. Patent Pub. 20210098105), hereinafter Lee.
Regarding claim 32, Juselius discloses a pen cap (cap 12) attachable to at least one insulin delivery device (pen 3), however, Juselius does not expressly state the pen cap comprising: a weighing system attached to a longitudinal end of the insulin delivery device, the weighing system comprising: at least one load cell disposed at a bottom of at least one cavity; and a control system comprising: at least one processor.
Lanigan teaches a fill adapter system for an infusion pump assembly (Abstract) comprising a weighing system (weight scale 2906) attached to a longitudinal end of the insulin delivery device (see FIG. 205), the weighing system comprising:
at least one load cell disposed at a bottom of at least one cavity (scale portion 2922; “The weight scale 2906 in some embodiments may be sized to accommodate a disposable assembly 2908.”, [0959]; the Examiner notes the internal cavity of station of 2900); and
a control system (electrical control assembly 110, see [0178]) comprising:
at least one processor (“electrical control assembly 110 may include two separate and distinct microprocessors”, [0728]); “In some embodiments, a processor may calculate the weight of the fluid filled and correlate the weight to a volume of fluid”, [0956]);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Juselius to include a weighing system attached to a longitudinal end of the insulin delivery device, the weighing system comprising: at least one load cell disposed at a bottom of at least one cavity; and a control system comprising: at least one processor. Doing so determines the volume of fluid filled into the disposable and may also be used for verification by comparing the before-use volume with the after-use volume of the disposable, as taught by Lanigan (see [0956]).
However, Juselius in view of Lanigan does not expressly state at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control system to receive weight data from the at least one load cell related to the at least one insulin delivery device.
Lee teaches a device, a computer-readable medium, and techniques that provide an onboarding process and an adaptivity process for a drug delivery device (Abstract) at least one non-transitory computer-readable storage medium (see [0123]) storing instructions thereon that, when executed by the at least one processor, cause the control system to receive weight data from the at least one load cell related to the at least one insulin delivery device (“non-transitory computer readable medium that is embodied with programming code executable by a processor is disclosed. The processor when executing the programming code is operable to perform functions, including functions to retrieve a portion of an insulin delivery history related to a user”, [0004]; see weighted sum in [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Juselius in view of Lanigan to include at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor, cause the control system to receive weight data from the at least one load cell related to the at least one insulin delivery device. Doing so would allow for selection of safety boundaries and limitations regarding the amount of insulin to be delivered, as taught by Lee (see [0004; 0040]).
Regarding claim 34, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 32, and Lanigan further teaches comprising at least one charging element (the Examiner notes charger portion 2924 has charging section 2904 which can be in FIG. 205 being disposed within station 2900) disposed within the at least one cavity.
Regarding claim 35, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 34, and Lanigan further teaches wherein the at least one charging element comprises at least one USB plug (“ Desktop charger 1250 may also include USB port 1258 (e.g., which may include a mini-USB port), allowing desktop charger to receive power (e.g., for charging the reusable housing assembly and/or the remote control assembly). Additionally/alternatively USB port 1258 may be configured for data transfer to/from remote control assembly and/or reusable housing assembly, e.g., by connection to a computer (not shown).” [0473]; “According to one embodiment, charger 2600 may utilize a mini-USB connection, e.g., which may provide power to charger 2600 as well as allowing data communication, e.g., between charger 2600 and an external computer”, [0490]).
Regarding claim 38, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 33, and Lanigan further teaches wherein the at least one load cell comprises a strain gauge load cell (“a strain gauge may be connected to the diaphragm (not shown) or other structural member supporting the resonant mass (not shown)”, [0690]).
Regarding claim 40, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 33, and Lee further teaches comprising instructions that, when executed by the at least one processor, cause the control system to wirelessly transmit the weight data to one or more of a cloud computing platform or a client device (“The smart phone may either store the new data collected or previously collected data or may be able to access a remote server, such as a cloud based server.”, [0097]; “In addition, the wearable drug delivery device 702 may be operable to communicate with the cloud-based services 711 via the communication device 726 and the communication link 788.”, [0107]; see [0118-0119]).
Claims 33, 36, 37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Juselius et al. (U.S. Patent Pub. 20020096543), hereinafter Juselius, further in view of Lanigan et al. (U.S. Patent Pub. 20100198182), hereinafter Lanigan, further in view of Lee et al. (U.S. Patent Pub. 20210098105), hereinafter Lee, further in view of Shaanan et al. (U.S. Patent Pub. 20120330556), hereinafter Shaanan.
Regarding claim 33, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 32, and Lanigan further teaches further comprising instructions that, when executed by the at least one processor (see processors of [0495]), cause the control system to:
monitor a charge level of a power source (“The battery charging circuit may, for example, monitor battery voltage and temperature (e.g., via information provided by the battery thermister via the six contact electrical connector).”, [0494]) of the at least one insulin delivery device (“infusion pump assembly 800. As with infusion pump assemblies 100, 100', 400, and 500, infusion pump assembly 800 may include reusable housing assembly 802”, [0398]); however, Juselius in view of Lanigan in view of Lee does not expressly state acquiring a charge level of the power source of the at least one insulin delivery device responsive to insertion of the at least one insulin delivery device into the at least one cavity.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) comprising instructions that, when executed by the at least one processor (see processor in [0037-0038]) acquire a charge level of the power source (see [0014;0035]) of the at least one insulin delivery device (insulin pen, see [0011]) responsive to insertion of the at least one insulin delivery device into the at least one cavity (“Docking station 300 can optionally be configured with a cradle or recessed portion for receiving device 200 in a secure manner.”, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Juselius in view of Lanigan in view of Lee to include instructions that, when executed by the at least one processor acquire a charge level of the power source of the at least one insulin delivery device responsive to insertion of the at least one insulin delivery device into the at least one cavity. Doing so would indicating a charge status and data exchange status, helping the user to determine whether results are within acceptable limits, as taught by Shaanan (see [0014]).
Regarding claim 36, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 34, however, Juselius in view of Lanigan in view of Lee does not expressly state wherein the at least one charging element comprises at least one inductive charging plate or coil.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) wherein the at least one charging element comprises at least one inductive charging plate or coil (“Power interface 310 is an inductive pad configured to provide electrical power to a rechargeable battery within device 200. An inductive pad advantageously allows device 200 to charge without physically mating with the docking station. In alternative embodiments, power interface 310 could comprise an electrical connector configured to mate with a connector on device 200.”, [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Juselius in view of Lanigan in view of Lee to include wherein the at least one charging element comprises at least one inductive charging plate or coil. Doing so provides wireless recharging capabilities, as taught by Shaanan (see [0030]).
Regarding claim 37, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 34, and Lanigan further discloses comprising instructions that, when executed by the at least one processor, cause the control system to transfer data to or receive data from the at least one insulin delivery device(“Electrical control assembly 110 may monitor and control the amount of infusible fluid that has been and/or is being pumped.”, [0178]) however, Juselius in view of Lanigan in view of Lee does not expressly state the transfer through the at least one charging element.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) further comprising instructions that, when executed by the at least one processor, cause the control system to transfer data to or receive data from the at least one insulin delivery device, through the at least one charging element (“] In one aspect of preferred embodiments, the testing device and/or the docking station has a communication facility configured to transmit and receive with an external storage device (e.g., a medical provider server, home computer, local area network). The communication facility can be wired or wireless. In preferred embodiments, the communication facility uses at least two wireless protocols. In other preferred embodiments, the communication facility transmits data a cell phone network. Contemplated data include test data, information derived from test data, and non-test data… In some aspects of preferred embodiments, the power interface is an inductive charging pad and the data interface is a wired connection, such as a USB port. The docking station can further include a second data interface, either wired or wireless, for exchanging data with an external device (e.g., home computer, laptop, smart phone, insulin pen, health test device).”, [0010-0011]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Juselius in view of Lanigan in view of Lee to include comprising instructions that, when executed by the at least one processor, cause the control system to transfer data to or receive data from the at least one insulin delivery device through the at least one charging element. Doing so provides wireless recharging capabilities and wireless data exchange, as taught by Shaanan (see [0010-0011]).
Regarding claim 39, Juselius in view of Lanigan in view of Lee teaches the claimed invention as discussed above concerning the rejection of claim 33, however, Juselius in view of Lanigan in view of Lee does not expressly state wherein the at least one cavity is configured to receive the injection pen.
Shaanan teaches an analyte testing system having an analyte testing device and a docking station (Abstract) wherein the at least one cavity is configured to receive the injection pen (see [0020; 0051-0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the control system of Juselius in view of Lanigan in view of Lee to include wherein the at least one cavity is configured to receive the injection pen. Doing so provides an external device for the docking station to transmit data too, as taught by Shaanan (see [0051-0052]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
02/02/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783