DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This Nonfinal Office Action is in response to the Request for Continued Examination filed 12/18/2025. Claims 1, 17, 22 and 30 have been amended. Claims 1 and 3-31 are currently pending and considered herein.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/11/2023 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 3-8, 10-24 and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 8,808,228 B2 to Brister et al., hereinafter “Brister,” in view of U.S. 2017/0136178 A1 to Kamen et al., hereinafter “Kamen,” in view of U.S. 2015/0126963 A1 to Despa et al., hereinafter “Despa” and further in view of U.S. 2017/0098058 A1 to McCullough et al., hereinafter “McCullough.”
Regarding claim 1, Brister discloses A mobile device, comprising: a display; a processor; a wireless communications interface; and a memory configured to store a medicament administration monitoring application (See Brister at least at Col. 22, ln. 30 – Col. 23, ln. 27; Figs. 9, 13, 17), wherein the processor is configured to: execute the medicament administration monitoring application (See id. at least at Col. 33, ln. 23-37; Col. 35, ln. 43-58; Figs. 13, 15, 16), wherein the supplementary device is releasably coupled to a medicament dispensing device configured to inject the dose of medicament into the patient through a needle (See id. at least at Abstract; Col. 2, ln. 1-9, ln. 17-23; Col. 3, ln. 33-39, ln. 52-53; Col. 20, ln. 1-12; Figs. 7, 17), and generate, via the medicament administration monitoring application, a record of medicament administration based on the dosage information (See id. at least at Col. 38, ln. 35 – Col. 39, ln. 22; Col. 40, ln. 14-49; Fig. 17).
Brister may not specifically describe a communications link for communicating dosage information to a supplementary device. However, Kamen teaches to establish, via the wireless communications interface, a communications link between the mobile device and a supplementary device (See Kamen at least at Paras. [0014]-[0016], [0164]-[0167], [0864], [0874]; Claim 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister to incorporate the teachings of Kamen and provide a communication link for dosage information. Kamen is directed to a wearable pump assembly for medication doses. See Kamen at Abstract. Incorporating the wearable pump assembly communication techniques as in Kamen with the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Brister as modified by Kamen may not specifically describe, but Despa teaches a supplementary device to allow dosage information associated with a dose of medicament injected into a patient to be transmitted between the supplementary device and the mobile device (See Despa at least at Abstract; Paras. [0005]-[0013] (a signal is transmitted from the injection device to the mobile device), [0040]-[0050] (injection device connected external device connected to mobile device and dose administration applications/progression), [0056], [0062]-[0064] (communicating injection information), [0074], [0092]-[0095], [0103] (dose administration, mobile device and supplementary device or injection device); Figs. 1, 2A, 3A); and wherein the processor is configured to establish the communications link automatically in response to a signal from the supplementary device to allow the processor to receive the dosage information from the supplementary device (See id. at least at Paras. [0004]-[0005], [0009], [0103], [0125] (transmitting signal of injection parameter between mobile and supplementary device), [0038] Figs. 1, 2A, 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister and Kamen to incorporate the teachings of Despa and provide the separate supplementary device transmitting dosage information to a mobile device. Despa is directed to an injection device configured to mate with a mobile device. See Despa at Abstract. Incorporating the injection device and mobile device technologies of Despa with the wearable pump assembly communication techniques as in Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
The references may not specifically describe but McCullough teaches to receive, from the supplementary device and while the medicament dispensing device is physically decoupled from the mobile device, the dosage information associated with the dose of medicament injected into the patient, the dosage information being transmitted from the supplementary device in response to completion of medicament delivery (See McCullough at least at Abstract; Paras. [0031], [0059]-[0069], [0085]-[0089], [0117], [0146]-[0149] (“Once the system 300 determines that the drug delivery is complete, the method 600 continues to block 634, where an informational prompt may be displayed by the local computing device 304 that the delivery is complete and that the device may be removed and disposed of (see FIG. 11), and block 636, where a report of the completion of the drug delivery by the user using the drug delivery device 302 is provided, for example, to the remote computing device 306.”); Figs. 3-6, 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister, Kamen and Despa to incorporate the teachings of McCullough and provide the supplementary device transmitting dosage information from the supplementary device to a computer device when uncoupled and when medicament delivery is completed. McCullough is directed to remotely processing data collected by a drug delivery device. See McCullough at Abstract. Incorporating the remote processing and sending of data between an uncoupled device and a computer device as in McCullough with the injection device and mobile device technologies of Despa, the wearable pump assembly communication techniques as in Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Regarding claim 3, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the processor is configured to establish the communications link in response to an input on the mobile device and/or in response to an input on the supplementary device (See Brister at least at Col. 39, ln. 36-54; See also Kamen at Paras [0014]-[0016], [0164]-[0167]; Claim 14).
Regarding claim 4, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the processor is configured to execute the medicament administration monitoring application in response to a user input applied to the mobile device (See Brister at least at Col. 29, ln. 51 – Col. 30, ln. 14; Col. 38, ln. 35 – Col. 39, ln. 54; Col. 45, ln. 13-51; Col. 19, ln. 8-59; Fig. 17).
Regarding claim 5, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the processor is configured to execute the medicament administration monitoring application automatically when a signal is received from the supplementary device or in response to an input on the supplementary device (See id.).
Regarding claim 6, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the wireless communications interface comprises a wireless transceiver configured to establish a connection to the supplementary device (See id. at least at Col. 31, ln. 45-51; Col. 45, ln. 13-51; See also Kamen at Paras [0014]-[0016], [0164]-[0167]; Claim 14).
Regarding claim 7, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the wireless communications interface is a Bluetooth interface or Bluetooth Low Energy interface (See Brister at least at Col. 6, ln. 64-67).
Regarding claim 8, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the record of medicament administration comprises at least one of time information, date information, and a type of medicament (See id. at least at Col. 1, ln. 62 – Col. 2, ln. 13).
Regarding claim 10, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 8, and Brister further discloses wherein the record of medicament administration comprises the type of medicament, wherein the type of medicament comprises insulin, and the dosage information comprises at least one of a dialed dose, an end dose, and a delivered dose (See id. at least at Col. 29, ln. 51 – Col. 30, ln. 14; Col. 38, ln. 35 – Col. 39, ln. 54; Col. 45, ln. 13-51; Col. 19, ln. 8-59; Col. 25, ln. 65 – Col. 26, ln. 42; Fig. 17).
Regarding claim 11, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the processor is configured to display the dosage information on the display (See id. at least at Col. 27, ln. 1-48; Fig. 4).
Regarding claim 12, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the processor is configured to cause the display to display the dosage information with an indication that a delivered dose is being displayed (See id. at least at Col. 4, ln. 9-21; Col. 27, ln. 1-48; Fig. 4).
Regarding claim 13, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the processor is configured to cause the display to display an indication that the record has been created or stored, wherein the indication is in the form of text or an image (See id. at least at Col. 39, ln. 55 – Col. 40, ln. 49).
Regarding claim 14, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the mobile device is configured to receive a user input indicating that a medicament delivery process is complete and is configured to control the display to display an indication that the medicament delivery process is complete (See id. at least at Col. 31, ln. 45 – Col. 32, ln. 47; Col. 39, ln. 55 – Col. 40, ln. 49; Figs. 1, 7, 13, 17).
Regarding claim 15, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the record of medicament administration is stored in the memory of the mobile device (See id. at least at Col. 31, ln. 17 – Col. 32, ln. 47; Col. 39, ln. 55 – Col. 40, ln. 49; Figs. 1, 7, 13, 17).
Regarding claim 16, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1, and Brister further discloses wherein the mobile device comprises a smart phone or a tablet that comprises a touch screen (See id. at least at Col. 21, ln. 52 – Col. 22, ln. 23).
Regarding claim 17, Brister discloses a dose monitoring and recording system for insulin administration, comprising: a supplementary device for attachment to an insulin delivery device, wherein the supplementary device comprises a first processor and a wireless communications unit, wherein the dosage information representing a dose of insulin administered by the insulin delivery device to the mobile device (See id. at least at Abstract; Col. 22, ln. 30 – Col. 23, ln. 27; Col. 33, ln. 23-37; Col. 35, ln. 43-58 Figs. 1, 10, 17, 18); and store, in the memory, a record of the dose of insulin based on the received data (See id. at least at Col. 31, ln. 52 – Col. 32, ln. 3; Col 37, ln. 22-57; Figs. 13, 16).
Brister may not specifically describe, but Kamen teaches A mobile device for receiving dosage information from the supplementary device (See Kamen at least at Paras. [0014]-[0016], [0164]-[0167], [0839], [0864], [0874]; Claim 14; Figs. 1, 2), wherein the mobile device comprises a processor, a wireless communications interface, a display, and a memory (See id.), wherein the mobile device is configured to: establish, via the wireless communications interface, a communications link between the mobile device and the supplementary device (See id.), receive, via the wireless communications interface, data transmitted from the wireless communications unit of the supplementary device, display, on the display, an indication of the dose of insulin administered (See id.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister to incorporate the teachings of Kamen and provide a communication link for dosage information. Kamen is directed to a wearable pump assembly for medication doses. Incorporating the wearable pump assembly communication techniques as in Kamen with the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Brister and Kamen may not specifically describe but Despa teaches the supplementary device is configured to transmit the dosage information to the mobile device (See Despa at least at Abstract; Paras. [0005]-[0013], [0040]-[0050], [0056], [0062]-[0064], [0074], [0092]-[0095], [0103] (dose administration, mobile device and supplementary device or injection device); Figs. 1, 2A, 3A); and a communications link between the mobile device and the supplementary device automatically in response to a signal from the supplementary device to allow the mobile device to receive the dosage information from the supplementary device (See id. at least at Paras. [0004]-[0005], [0009], [0103], [0125] (transmitting signal of injection parameter between mobile and supplementary device), [0038] Figs. 1, 2A, 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister and Kamen to incorporate the teachings of Despa and provide the separate supplementary device transmitting dosage information to a mobile device. Despa is directed to an injection device configured to mate with a mobile device. See Despa at Abstract. Incorporating the injection device and mobile device technologies of Despa with the wearable pump assembly communication techniques as in Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
The references may not specifically describe but McCullough teaches to receive, via the wireless communications interface and while the insulin delivery device is physically decoupled from the mobile device, the dosage information transmitted from the wireless communications unit of the supplementary device, the dosage information being transmitted from the supplementary device in response to completion of insulin delivery (See McCullough at least at Abstract; Paras. [0031], [0059]-[0069], [0085]-[0089], [0117] (wireless transmitter), [0146]-[0149] (“Once the system 300 determines that the drug delivery is complete, the method 600 continues to block 634, where an informational prompt may be displayed by the local computing device 304 that the delivery is complete and that the device may be removed and disposed of (see FIG. 11), and block 636, where a report of the completion of the drug delivery by the user using the drug delivery device 302 is provided, for example, to the remote computing device 306.”); Figs. 3-6, 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister, Kamen and Despa to incorporate the teachings of McCullough and provide the supplementary device transmitting dosage information from the supplementary device to a computer device when uncoupled and when medicament delivery is completed. McCullough is directed to remotely processing data collected by a drug delivery device. See McCullough at Abstract. Incorporating the remote processing and sending of data between an uncoupled device and a computer device as in McCullough with the injection device and mobile device technologies of Despa, the wearable pump assembly communication techniques as in Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Regarding claim 18, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 17, and Brister further discloses wherein the supplementary device comprises a button configured to turn the supplementary device on or off, and the button is located at a proximal end of the supplementary device (See id. at least at Col. 22, ln. 1-67; Col. 25, ln. 17-44; Figs. 1, 7, 10, 13, 17).
Regarding claim 19, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 17, and Brister further discloses wherein the insulin delivery device has a distal end configured to receive a needle (See id. at least at Col. 27, ln. 1-47; Figs. 4, 11).
Regarding claim 20, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 17, and Brister further discloses wherein the insulin delivery device comprises a dosage dial configured to turn to set the dose of insulin to be administered by the insulin delivery device, the dosage dial being located at a proximal end of the insulin delivery device, wherein the supplementary device is configured for coupling to the proximal end of the insulin delivery device (See id. at least at Col. 28, ln. 16-41; Fig. 5).
Regarding claim 21, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 17, and Brister further discloses wherein the mobile device is configured to store, in the memory, a dose diary containing a plurality of records tracking a plurality of doses of insulin based on the received dosage information (See id. at least at Col. 37, ln. 16-62; Figs. 13, 16).
Regarding claim 22, Brister teaches A method for monitoring and recording insulin administration, comprising: executing, by a processor of a mobile device of a monitoring system, a medicament administration monitoring application preloaded in a memory of the mobile device (See Brister at least at Abstract; Col. 22, ln. 30 – Col. 23, ln. 27; Col. 33, ln. 23-37; Col. 35, ln. 43-58 Figs. 1, 10, 17, 18); detecting, by a processor of a supplementary device of the monitoring system, a depression of a button located at a proximal end of the supplementary device to activate the supplementary device and establishing a wireless communication link between the supplementary device of the monitoring system and the mobile device to receive dosage information (See id. at least at Col. 22, ln. 1-67; Col. 25, ln. 17-44; Figs. 1, 7, 10, 13, 17) and wherein the supplementary device is attached to a proximal end of an insulin delivery device, wherein the insulin delivery device has a distal end configured to receive a needle (See id. at least at Col. 27, ln. 1-47; Figs. 4, 11).
Brister may not specifically describe, but Kamen teaches capturing, by the supplementary device, data the dosage information, wherein the dosage information is representative of a dialed dose of insulin of the insulin delivery device (See Kamen at least at Paras. [0014]-[0016], [0164]-[0167], [0839], [0864], [0874]; Claim 14; Figs. 1, 2); transmitting, by the processor of the supplementary device, the dosage information representing the dialed dose of insulin to the mobile device (See id.); and executing, by the processor of the mobile device, the medicament administration monitoring application to record the dosage information representing the dialed dose of insulin in the memory of the mobile device (See id.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister to incorporate the teachings of Kamen and provide a communication link for dosage information. Kamen is directed to a wearable pump assembly for medication doses. Incorporating the wearable pump assembly communication techniques as in Kamen with the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Brister and Kamen may not specifically describe but Despa teaches wherein establishing the wireless communication link comprises establishing, by the processor of the mobile device, the wireless communication link automatically in response to the processor of the mobile device receiving a signal from the supplementary device to allow the mobile device to receive the dosage information from the supplementary device (See Despa at least at Paras. [0004]-[0005], [0009], [0103], [0125] (transmitting signal of injection parameter between mobile and supplementary device), [0038] Figs. 1, 2A, 3A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister and Kamen to incorporate the teachings of Despa and provide the separate supplementary device transmitting dosage information to a mobile device. Despa is directed to an injection device configured to mate with a mobile device. See Despa at Abstract. Incorporating the injection device and mobile device technologies of Despa with the wearable pump assembly communication techniques as in Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
The references may not specifically describe but McCullough teaches transmitting, by the processor of the supplementary device, in response to completion of insulin delivery and while the insulin delivery device is physically decoupled from the mobile device (See McCullough at least at Abstract; Paras. [0031], [0059]-[0069], [0085]-[0089], [0146]-[0149] (“Once the system 300 determines that the drug delivery is complete, the method 600 continues to block 634, where an informational prompt may be displayed by the local computing device 304 that the delivery is complete and that the device may be removed and disposed of (see FIG. 11), and block 636, where a report of the completion of the drug delivery by the user using the drug delivery device 302 is provided, for example, to the remote computing device 306.”); Figs. 3-6, 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure Brister, Kamen and Despa to incorporate the teachings of McCullough and provide the supplementary device transmitting dosage information from the supplementary device to a computer device when uncoupled and when medicament delivery is completed. McCullough is directed to remotely processing data collected by a drug delivery device. See McCullough at Abstract. Incorporating the remote processing and sending of data between an uncoupled device and a computer device as in McCullough with the injection device and mobile device technologies of Despa, the wearable pump assembly communication techniques as in Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Regarding claim 23, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, and Brister further discloses wherein the wireless communication link uses Bluetooth pairing (See id. at least at Col. 6, ln. 64-67).
Regarding claim 24, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, and Brister further discloses displaying an indication of the dialed dose of insulin on a display of the mobile device. (See id. at least at Col. 29, ln. 51 – Col. 30, ln. 14; Col. 38, ln. 35 – Col. 39, ln. 54; Col. 45, ln. 13-51; Col. 19, ln. 8-59; Col. 25, ln. 65 – Col. 26, ln. 42; Figs. 7, 13, 17).
Regarding claim 26, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, and Brister further discloses capturing a time or a date of insulin injection using a clock of the mobile device (See id. at least at Col. 3, ln. 20-25).
Regarding claim 27, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, and Brister further discloses pre-processing the dosage information representing the dialed dose of insulin by the processor of the supplementary device (See id. at least at Col. 38, ln. 35 – Col. 40, ln. 13; Col. 45, ln. 13-51; Col. 19, ln. 8-59; Col. 25, ln. 65 – Col. 26, ln. 42; Figs. 1, 7, 13, 17).
Regarding claim 28, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, and Brister further discloses additional processing of the dosage information representing the dialed dose of insulin by the processor of the mobile device (See id.).
Regarding claim 29, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, and Brister further discloses recording a plurality of the dosage information representing a plurality of dialed doses of insulin in the memory of the mobile device (See id.; Also see id. at Col. 31, ln. 45 – Col. 32, ln. 3).
Regarding claim 30, claim 30 is rejected under the same grounds of rejection and for the same reasoning as applied to substantially similar limitations in independent claim 17, above. Furthermore, Brister discloses the additional limitation to generate, via the medicament administration monitoring application, a record of medicament administration based on the dosage information, wherein the dosage information comprises a dialed dose and a final dose, and wherein the processor is further configured to: if the final dose is zero, confirm that the dialed dose is a delivered dose, and if the final dose is greater than zero, determine the delivered dose by subtracting the final dose from the dialed dose (See id. at least at Col. 13, ln. 24-48; Col. 29, ln. 51 – Col. 30, ln. 14; Col. 38, ln. 35 – Col. 39, ln. 22; Col. 29, ln. 51 – Col. 30, ln. 14; Col. 38, ln. 35 – Col. 39, ln. 54; Col. 45, ln. 13-51; Col. 19, ln. 8-59; Figs. 1, 7, 10, 13, 17, 18; Col. 25, ln. 65 – Col. 26, ln. 41).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Brister, in view of Kamen, in view of Despa, in view of McCullough and further in view of U.S. 2017/0032211 A1 to Allerdings et al., hereinafter “Allerdings.”
Regarding claim 9, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 8, but may not specifically describe wherein the type of medicament is based on a signal received by a color sensor configured to detect a color of the medicament dispensing device, and wherein the color of the medicament dispensing device is indicative of the type of medicament. However, Allerdings teaches wherein the record of medicament administration comprises the type of medicament, wherein the type of medicament is based on a signal received by a color sensor configured to detect a color of the medicament dispensing device, and wherein the color of the medicament dispensing device is indicative of the type of medicament (See Allerdings at least at Para. [0063]; See also Brister at least at Col. 33, ln. 36 – Col. 34, ln. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Brister, Kamen, Despa and McCullough to incorporate the teachings of Allerdings and provide a signal to detect a color of the medicament dispensing device that indicates the type or dosage of medicament. Allerdings is directed to a supplemental device for attachment to an injection device for recording and displaying a dose value set by the user. See Allerdings at Abstract. Incorporating the supplemental device, injection device, and sensing and displaying device as in Allerdings with the remote processing and sending of data between an uncoupled device and a computer device as in McCullough, the injection device and mobile device technologies of Despa, the wearable pump assembly of Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Brister, in view of Kamen, in view of Despa, in view of McCullough and further in view U.S. 2013/0191140 A1 to Fotheringham et al., hereinafter “Fotheringham.”
Regarding claim 25, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 22, but may not specifically describe downloading the medicament administration monitoring application to the mobile device from an application marketplace or an application store. However, Fotheringham teaches downloading the medicament administration monitoring application to the mobile device from an application marketplace or an application store (See Fotheringham at least at Paras. [0040]-[0042; Fig. 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Brister, Kamen, Despa and McCullough to incorporate the teachings of Fotheringham and provide downloading the medicament dosage application from a store or marketplace. Fotheringham is directed to a caregiver process and systems. Incorporating the caregiver processes and device functions as in Fotheringham with the remote processing and sending of data between an uncoupled device and a computer device as in McCullough, the injection device and mobile device technologies of Despa, the wearable pump assembly of Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Brister, in view of Kamen, in view of Despa, in view of McCullough and further in view U.S. 2016/0038675 A1 to Estes et al., hereinafter “Estes.”
Regarding claim 31, Brister as modified by Kamen, Despa and McCullough teaches all the limitations of claim 1. The references may not specifically describe but Estes teaches wherein the processor is further configured to establish the communications link automatically or automatically in response to a signal that the supplementary device has been powered on (See Estes at least at Paras. [0048]-[0049] (“the electrical connection between the pump device 100 and the controller device 200 can permit the transmission of electrical control signals to the pump device 100 and the reception of feedback signals (e.g., sensor signals) from particular components within the pump device 100. The electrical connection between the pump device 100 and the controller device 200 may similarly facilitate transmission of one or more power signals for sharing electrical power therebetween.”); Figs. 1, 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Brister, Kamen, Despa and McCullough to incorporate the teachings of Estes and provide a connection when devices are powered on. Estes is directed to an infusion pump assembly and method. Incorporating the infusion pump and controller as in Estes with the remote processing and sending of data between an uncoupled device and a computer device as in McCullough, the injection device and mobile device technologies of Despa, the wearable pump assembly of Kamen and the integrated medicament delivery device and sensing device and mobile device as in Brister would thereby improve the applicability, efficacy, and accuracy of the claimed monitoring system and methods.
Response to Arguments
Applicant’s RCE filed December 18, 2025 has been fully considered, but the arguments therein are not persuasive. The following explains why:
Applicant’s arguments pertaining to prior art rejections are not persuasive. The claims have been addressed with regard to the 35 U.S.C. §103 rejection discussed above. The arguments pertaining to prior art references of the Applicant’s Remarks are not persuasive. The arguments are moot in light of at least new reference McCullough, discussed above. As such, it is submitted that the cited prior art, including those identified by Applicant, in the same field of endeavor, i.e., medical diagnostics, and medicament injection and dosing/administration techniques, teaches and/or suggests all of the limitations of the pending claims under a broad and reasonable interpretation thereof.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM T. MONTICELLO whose telephone number is (313)446-4871. The examiner can normally be reached M-Th; 08:30-18:30 EST.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARC Q. JIMENEZ can be reached at (571) 272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM T. MONTICELLO/Examiner, Art Unit 3681
/MARC Q JIMENEZ/Supervisory Patent Examiner, Art Unit 3681