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 .
This action is in response to Applicant’s amendments filed 7/22/2026.
Claims 1, 13, 34, 38, 39, and 51 are amended.
Claims 12, 20, 23, and 43 are cancelled.
Claims 1-11, 13-19, 21, 22, 24-42, and 44-53 are being examined in this Office Action.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites the limitation “wherein the first user input does not include input manually setting the calculated dose” in lines 12-13. This is grammatically ambiguous. Examiner recommends amending the limitation to read “wherein the first user input does not include
Claim 8 recites the limitation “a first user input” in line 3. It is unclear if this is the same first user input as recited in Claim 1, or if this is a separate first user input. Examiner recommends amending the limitation to read “the first user input”.
Claim 9 recites the limitation “a second user input” in lines 4-5. It is unclear if this is the same second user input as recited in Claim 1, or if this is a separate second user input. Examiner recommends amending the limitation to read “the second user input”.
Claim 15 recites the limitation “the amount” in line 3. Examiner recommends amending the limitation to read “the amount of the medicament”.
Claim 32 recites the limitation “the amount” in line 2. Examiner recommends amending the limitation to read “the amount of the medicament”.
Claim 34 recites the limitation “wherein the first user input does not include input manually setting the calculated bolus amount” in lines 13-14. This is grammatically ambiguous. Examiner recommends amending the limitation to read “wherein the first user input does not include
Claim 39 recites the limitation “the amount” in line 2. Examiner recommends amending the limitation to read “the amount of the medicament”.
Appropriate correction is required.
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.
Claims 2, 5-9, 11, 24, 37, 40-42, and 44-53 are 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 2 recites the limitation “the user input” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the user input” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation “a user interface of the medicament injection pen” in line 2. It is unclear if this is a separate user interface of the medicament injection as one is previously recited in claim 1.
Claim 8 recites the limitation “the user input” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the user input” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “wherein the receiving the user input to initiate the injection of the medicament comprises receiving the user input via a user interface of the computing device.” It is unclear how the computing device receives the user input via a user interface of the computing device, when claim 1 requires the first and second user input to be received via the medicament injection pen.
Claim 24 recites the limitation “the computing device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation “a user interface” in line 3. It is unclear if this is a separate user interface as “a user interface of the medicament injection pen” is recited in claim 34. Examiner interprets “a user interface” to be referencing the user interface of the medicament injection pen as recited in claim 34.
Claim 40 recites the limitation “wherein the medicament injection pen has a user interface” in lines 1-2. It is unclear if this is the same, or separate user interface as recited in claim 34.
All remaining claims are rejected by virtue of their dependence on a rejected claim.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1-11, 13-19, 22, 24, 29, 32-42, 45, 52, and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haider et al. (Pub. No. US 20170216524 A1, herein Haider).
Regarding Claim 1, Haider discloses a method (Paragraph [0044]) comprising:
receiving, by a medicament injection pen (256) from an analyte monitoring device (254) worn by a user (102), analyte monitoring data (“the injection device 256 can also perform data recording of glucose monitoring data received from the CGM 254” – Paragraph [0044]);
determining, by the medicament injection pen based on the analyte monitoring data, that a blood glucose level of the user exceeds a threshold (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment. Determinations may be based on both current and historical trend data.” – Paragraph [0045]);
calculating, by the medicament injection pen in response to the determining, a dose of a medicament to administer to the user via the medicament injection pen based on the analyte monitoring data (“The injection device 256 can also include computing capabilities for determining insulin dose requirements.” – Paragraph [0044]);
outputting, via a user interface (306) of the medicament injection pen, a notification indicating the calculated dose (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment… For example, the injection device 256 may display a notification on a user interface of the injection device 256. The user interface may display a current glucose level, a notification that the glucose level is high or low, a notification that an insulin injection is required, or a notification that emergency medical assistance is required.” – Paragraph [0045], Fig. 3A, Examiner interprets that a notification that an insulin injection is required would include an insulin dosage amount).
Haider does not expressly disclose receiving, via the medicament injection pen, a first user input verifying the calculated dose after outputting the notification, wherein the first user input does not include input manually setting the calculated dose;
receiving, via the medicament injection pen after receiving the first user input, a second user input to initiate an injection of the medicament; and
operating the medicament injection pen to administer the calculated dose to the user in response to receiving the second user input to initiate the injection.
However, Haider teaches where the injection device (256) may display a notification on a user interface (306) of the injection device (Paragraph [0045]) and wherein the user interface buttons (303 and 304) can be configured to select between one or more options displayed on the display (Paragraph [0054]), then requiring another user input priming and operating the injection device to expel fluid from a needle (Paragraphs [0047], [0048], and [0050]).
A person having ordinary skill in the art, wanting to provide a notification to a user regarding a calculated dosage on the injection pen itself, and require inputs on the medicament injection pen, instead of a separate device, would have modified the medicament injection pen disclosed by Haider to display the calculated dose on the display of the medicament injection pen and require a first user input to verify the calculated dose using the user interface buttons, before requiring a second user input to initiate injection of the medicament and operate the medicament injection pen to administer the calculated dose to the user in response to receiving the second user input to initiate the injection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Haider to include receiving, via the medicament injection pen, a first user input verifying the calculated dose after outputting the notification, wherein the first user input does not include input manually setting the calculated dose; receiving, via the medicament injection pen after receiving the first user input, a second user input to initiate an injection of the medicament; and operating the medicament injection pen to administer the calculated dose to the user in response to receiving the second user input to initiate the injection as taught by Haider so that user can rely on the injection device to verify information and administer doses (Paragraph [0054]).
Regarding Claim 2, modified Haider discloses the method of claim 1, wherein the operating the medicament injection pen to administer the calculated dose of the medicament to the user in response to receiving the user input to initiate the injection (Paragraph [0047]) comprises powering a motorized pump (322) of the medicament injection pen to flow the calculated dose from a medicament reservoir (308) of the medicament injection pen through a needle (309) of the medicament injection pen (Paragraph [0053]).
Regarding Claim 3, modified Haider discloses the method of claim 1.
Modified Haider does not expressly disclose further comprising estimating an amount of active medicament present in the user based on a dosage log of previously injected doses of the medicament, and wherein the calculating the dose of the medicament to administer to the user via the medicament injection pen is further based on the amount of active medicament present in the user.
However, in a differing embodiment Haider teaches further comprising estimating an amount of active medicament present in the user based on a dosage log of previously injected doses of the medicament (“The results of the injection, including dose amount, time of injection, and whether the injection was successful, are stored in a memory of the injection device 256 and transmitted to the hub 400” – Paragraph [0059]), and wherein the calculating the dose of the medicament to administer to the user via the medicament injection pen is further based on the amount of active medicament present in the user (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment. Determinations may be based on both current and historical trend data.” – Paragraph [0045], examiner interprets that a dosage information may be stored in the memory and the injection device 256 may be able to reference that data to determine a current amount of insulin in a user in order to determine another dose of insulin).
Regarding Claim 4, modified Haider discloses the method of claim 1, further comprising determining a blood glucose level of the user based on the analyte monitoring data (362), the analyte monitoring data received from an analyte monitoring device worn by the user (254), and wherein the calculating the dose of the medicament to administer to the user via the medicament injection pen based on the analyte monitoring data is in response to the blood glucose level of the user being greater than a threshold (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment. “- Paragraph [0045], Examiner interprets the requirement of emergency medical treatment would need the determination of blood glucose level being above or below a normal limit).
Regarding Claim 5, modified Haider discloses the method of claim 1, further comprising outputting a notification regarding the calculated dose prior to receiving the user input to initiate the injection (“The injection device 256 can also notify a user of various conditions and events in response to the status determinations… For example, the injection device 256 may display a notification on a user interface of the injection device 256. The user interface may display a current glucose level, a notification that the glucose level is high or low, a notification that an insulin injection is required, or a notification that emergency medical assistance is required.” - Paragraph [0045]).
Regarding Claim 6, modified Haider discloses the method of claim 5, wherein the outputting the notification comprises outputting the notification via a user interface of the medicament injection pen (“he injection device 256 may display a notification on a user interface of the injection device 256” – Paragraph [0045]), and wherein the receiving the user input to initiate the injection comprises receiving the user input via the user interface or an electronic button of the medicament injection pen (303 and 304 in Fig. 3A).
Regarding Claim 7, modified Haider discloses the method of claim 5, wherein outputting the notification comprises outputting the notification via a user interface (Fig. 2A) of a computing device (252) that is communicatively coupled to the medicament injection pen (“Notifications may also be transmitted to external devices, such as the smartphone 252, and to medical personnel for data tracking or emergency services.” – Paragraph [0045]).
Regarding Claim 8, modified Haider discloses the method of claim 5, wherein the notification comprises a first notification (determined dose displayed on 306, Fig. 3A) indicating the calculated dose of the medicament, and wherein the receiving the user input to initiate the injection comprises receiving a first user input verifying the calculated dose of the medicament after outputting the first notification (Paragraph [0047], Examiner interprets that the determined dose is displayed on display 306, before the user presses either 303 or 304).
Regarding Claim 9, modified Haider discloses the method of claim 8, further comprising outputting, in response to receiving the first user input (303 or 304), a second notification including instructions to position the medicament injection pen to inject the calculated dose of the medicament into the user (“The prime screen may include a “needle positioning” field which can include information related to the position of the needle 309” – Paragraph [0058]), and wherein the receiving the user input to initiate the injection further comprises receiving a second user input (inject/prime button 301) confirming positioning of the medicament injection pen after outputting the second notification (Paragraph [0047]).
Regarding Claim 10, modified Haider discloses the method of claim 1, wherein the medicament injection pen is communicatively coupled to a computing device (252), and the operating the medicament injection pen to administer the calculated dose to the user is further in response to the medicament injection pen receiving, from the computing device, instructions to administer the calculated dose (“the smart phone 252 can determine insulin dose requirements, both basal and bolus, based on the patient's physiological information, including glucose concentration measurements and history. The injection device 256 can also include computing capabilities for determining insulin dose requirements. The injection device 256 performs priming and bolus injection, based on a dose amount determined and transmitted to a controller in the smart pen injection device 256” – Paragraph [0044]).
Regarding Claim 11, modified Haider discloses the method of claim 10, wherein the receiving the user input to initiate the injection of the medicament comprises receiving the user input via a user interface (screen of smartphone 252) of the computing device (“system 250 includes wireless connectivity between the smart pen injection device 256 and the CGM 254 and the smart phone 252. In some embodiments, one or more of the injection device 256 and the smartphone 252 can connect to and communicate with other external devices that measure or receive dosage relevant information, such as physical activity information, sleep information, diet information, weight information, and other medicine used information. In some embodiments, the dosage relevant information can be input into the smartphone 252.” – Paragraph [0044]).
Regarding Claim 13, Haider discloses a system (Fig. 2) comprising:
an analyte monitoring (254) device worn by the user (similar to how CGM 106 is worn by a user in Fig. 1B) and configured to obtain analyte measurements of the user (Paragraph [0044]);
a medicament injection pen (256) to administer a medicament to the user; and
at least a memory (324) and a processor (320) included in the medicament injection pen (Fig. 3) to perform operations comprising:
receiving, by the medicament injection pen from the analyte monitoring device, the analyte measurements (“The injection device 256 may regularly communicate with one or more of the CGM 254, the smart phone 252, and the other external devices.” – Paragraph [0044]);
calculating, based on the analyte measurements, a blood glucose level of the user (“the injection device 256 can process data received from one or more of the CGM 254, the smart phone 252 and the other external devices to determine a status of a user. For example, the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment. Determinations may be based on both current and historical trend data.” – Paragraph [0045]);
calculating, by the medicament injection pen, an amount of the medicament to administer to the user in response to the blood glucose level of the user exceeding the threshold (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment” – Paragraph [0045]); and
outputting, via a user interface (306) of the medicament injection pen, a notification indicating the calculated amount (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment… For example, the injection device 256 may display a notification on a user interface of the injection device 256. The user interface may display a current glucose level, a notification that the glucose level is high or low, a notification that an insulin injection is required, or a notification that emergency medical assistance is required.” – Paragraph [0045], Fig. 3A, Examiner interprets that a notification that an insulin injection is required would include an insulin dosage amount).
Haider does not expressly disclose receiving, via the medicament injection pen, a first user input verifying the calculated amount after outputting the notification, wherein the first user input does not include input manually setting the calculated amount; and
providing instructions causing the medicament injection pen to deliver the amount of the medicament to the user in response to receiving the first user input and receiving an indication that a needle of the medicament injection pen is inserted into the user, wherein receiving the indication comprises receiving, via the medicament injection pen after receiving the first user input, a second user input.
However, Haider teaches where the injection device (256) may display a notification on a user interface (306) of the injection device (Paragraph [0045]) and wherein the user interface buttons (303 and 304) can be configured to select between one or more options displayed on the display (Paragraph [0054]), then requiring a another user input priming and operating the injection device to expel fluid from a needle (Paragraphs [0047], [0048], and [0050]).
A person having ordinary skill in the art, wanting to provide a notification to a user regarding a calculated dosage on the injection pen itself, and require inputs on the medicament injection pen, instead of a separate device, would have modified the medicament injection pen disclosed by Haider to display the calculated dose on the display of the medicament injection pen and require a first user input to verify the calculated dose using the user interface buttons, before requiring a second user input to initiate injection of the medicament and operate the medicament injection pen to administer the calculated dose to the user in response to receiving the second user input to initiate the injection. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Haider to include receiving, via the medicament injection pen, a first user input verifying the calculated amount after outputting the notification, wherein the first user input does not include input manually setting the calculated amount; and providing instructions causing the medicament injection pen to deliver the amount of the medicament to the user in response to receiving the first user input and receiving an indication that a needle of the medicament injection pen is inserted into the user, wherein receiving the indication comprises receiving, via the medicament injection pen after receiving the first user input, a second user input as taught by Haider so that user can rely on the injection device to verify information and administer doses (Paragraph [0054]).
Regarding Claim 14, modified Haider discloses the system of claim 13, wherein the amount of the medicament is determined based at least in part on the analyte measurements of the user obtained from the analyte monitoring device (“The injection device 256 performs priming and bolus injection, based on a dose amount determined and transmitted to a controller in the smart pen injection device 256. One or more of the smart phone 252 and the injection device 256 can also perform data recording of glucose monitoring data received from the CGM 254, and insulin injections performed by the injection device 256” – Paragraph [0044]).
Regarding Claim 15, modified Haider discloses the system of claim 13, wherein the instructions cause the medicament injection pen to deliver the amount of the medicament to the user without receiving user input setting the amount (“the injection device 256 can process data received from one or more of the CGM 254, the smart phone 252 and the other external devices to determine a status of a user. For example, the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment” – Paragraph [0045], “Once the dose is determined, the injection device 256 may inject the determined dose” – Paragraph [0047]).
Regarding Claim 16, modified Haider discloses the system of claim 13, wherein the medicament comprises insulin (insulin within insulin cartridge 308 to be injected, Fig. 3), and wherein the medicament injection pen comprises a motorized pump (322 with plunger 313 moving within insulin cartridge 308 to pen needle 309, Fig. 3).
Regarding Claim 17, modified Haider discloses the system of claim 13, wherein the medicament injection pen has a user interface (“ the injection device 256 may display a notification on a user interface of the injection device 256” – Paragraph [0045]) for receiving user input causing the medicament injection pen to initiate delivery of the amount of the medicament to the user (“the user can prime the insulin cartridge by selecting the “prime” screen from the user interface of the injection device 256. Pressing the enter button 302 and then selecting the prime function followed by pressing the inject/prime button 301 causes the injection device 256 to extend a plunger into a medicament cartridge, causing the medicament cartridge to expel fluid from a needle.” – Paragraph [0047]).
Regarding Claim 18, modified Haider discloses the system of claim 13, wherein the medicament injection pen includes a user interface for establishing wireless communication with an external device (“The system 250 includes a smart phone 252, a CGM 254 and a smart pen injection device 256. The injection device 256 communicates wirelessly with the CGM 254 and/or the smart phone 252. The wireless connections may utilize any suitable wireless protocol” – Paragraph [0044], Examiner interprets connection of medicament injection pen to smart phone requires inputting instructions to either the injection pen or phone through an interface).
Regarding Claim 19, modified Haider discloses the system of claim 18, wherein the external devices (252) is the analyte monitoring system (“the smart phone 252 can determine insulin dose requirements, both basal and bolus, based on the patient's physiological information, including glucose concentration measurements and history” – Paragraph [0044]).
Regarding Claim 22, modified Haider discloses the system of claim 13, wherein the memory (324) and the processor (320) are included in the medicament injection pen (Fig. 3).
Regarding Claim 24, modified Haider discloses the system of claim 13, wherein the computing device (252) receives the analyte measurements from the analyte monitoring device over a wireless connection (“The injection device 256 communicates wirelessly with the CGM 254 and/or the smart phone 252.” – Paragraph [0044]).
Regarding Claim 29, modified Haider discloses the system of claim 13, wherein the medicament injection pen includes a display for displaying analyte measurements (306, Fig. 3A, Paragraph [0052]).
Regarding Claim 32, modified Haider discloses the system of claim 13, wherein the amount of the medicament to administer is a bolus dose (“The injection device 256 performs priming and bolus injection, based on a dose amount determined and transmitted to a controller in the smart pen injection device 256.” – Paragraph [0044]).
Modified Haider does not expressly disclose calculating the amount includes dividing the bolus dose into a plurality of smaller doses that are to be administered at intervals determined by the memory and the processor.
However, Haider discloses that the injection device may process data regularly, semi-regularly, continuously, near continuously, or intermittently (Paragraph [0045]), the requirement for a dose is based on current and historical trend data (Paragraph [0045]), and that the injection device can include computing capabilities for determining insulin dose requirements (Paragraph [0044]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by modified Haider wherein calculating the amount includes dividing the bolus dose into a plurality of smaller doses that are to be administered at intervals determined by the memory and the processor as taught by Haider so that a user may inject a smaller dose, measure the blood glucose of the user, and determine if an additional dose is necessary (Paragraph [0045]).
Regarding Claim 33, modified Haider discloses the system of claim 32, wherein determining to divide the bolus does into a plurality of smaller doses is based on receipt of user input (“the dosage relevant information can be input into the smartphone 252” – Paragraph [0044]).
Regarding Claim 34, Haider discloses a method (Paragraph [0044]) comprising:
receiving, by a medicament injection pen (256) from a glucose monitoring device (254) worn by a user (similar to how CGM 106 is worn by a user in Fig. 1A), glucose measurements of the user (Paragraph [0044]);
determining, by the medicament injection pen based on the glucose measurements, that a blood glucose level of the user exceeds a threshold (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment.” – Paragraph [0045]);
calculating, by the medicament injection pen in response to the determining, a bolus amount of medicament to administer to the user via the medicament injection pen based at least in part on the glucose measurements (“The injection device 256 can also include computing capabilities for determining insulin dose requirements… the smart phone 252 can determine insulin dose requirements, both basal and bolus” – Paragraph [0044]);
outputting, via a user interface (306) of the medicament injection pen, a notification regarding administering the calculated bolus amount of the medicament to the user (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment… For example, the injection device 256 may display a notification on a user interface of the injection device 256. The user interface may display a current glucose level, a notification that the glucose level is high or low, a notification that an insulin injection is required, or a notification that emergency medical assistance is required.” – Paragraph [0045], Fig. 3A, Examiner interprets that a notification that an insulin injection is required would include an insulin dosage amount).
Haider does not expressly disclose receiving, via the medicament injection pen, a first user input verifying administration of the calculated bolus amount after outputting the notification, wherein the first user input does not include input manually setting the calculated bolus amount;
receiving an indication that a needle of the medicament injection pen is inserted into the user, wherein receiving the indication comprises receiving, via the medicament injection pen after receiving the first user input, a second user input; and
operating a motorized pump of the medicament injection pen to deliver the bolus amount of the medicament to the user via at least one injection in response to receiving the first user input and the indication that the needle of the medicament injection pen is inserted into the user.
However, Haider teaches where the injection device (256) may display a notification on a user interface (306) of the injection device (Paragraph [0045]) and wherein the user interface buttons (303 and 304) can be configured to select between one or more options displayed on the display (Paragraph [0054]), then requiring a user input priming and operating the injection device to expel fluid from a needle (Paragraphs [0047], [0048], and [0050]).
A person having ordinary skill in the art, wanting to provide a notification to a user regarding a calculated dosage on the injection pen itself, and require inputs on the medicament injection pen, instead of a separate device, would have modified the medicament injection pen disclosed by Haider to display the calculated dose on the display of the medicament injection pen and require a first user input to verify the calculated dose using the user interface buttons, before requiring a second user input to initiate injection of the medicament and operate the medicament injection pen to administer the calculated dose to the user in response to receiving the second user input to initiate the injection. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Haider to include receiving, via the medicament injection pen, a first user input verifying administration of the calculated bolus amount after outputting the notification, wherein the first user input does not include input manually setting the calculated bolus amount; receiving an indication that a needle of the medicament injection pen is inserted into the user, wherein receiving the indication comprises receiving, via the medicament injection pen after receiving the first user input, a second user input; and operating a motorized pump of the medicament injection pen to deliver the bolus amount of the medicament to the user via at least one injection in response to receiving the first user input and the indication that the needle of the medicament injection pen is inserted into the user as taught by Haider so that user can rely on the injection device to verify information and administer doses (Paragraph [0054]).
Regarding Claim 35, modified Haider discloses the method of claim 34 further comprising obtaining glucose measurements of the user from a glucose monitoring device (254, Paragraph [0044]) worn by the user, and wherein the calculating the bolus amount of the medicament to administer to the user in response to the blood glucose level of the user exceeding a threshold comprises calculating the bolus amount based at least in part on the glucose measurements (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment” – Paragraph [0045], examiner interprets the requirement of emergency medical treatment would need the determination of blood glucose level being above or below a normal limit).
Regarding Claim 36, modified Haider discloses the method of claim 35.
Modified Haider does not expressly disclose further comprising determining an active amount of the medicament in the user based at least in part on a dosage log of medicament delivery to the user, and wherein the calculating the bolus amount of the medicament to administer to the user in response to the blood glucose level of the user exceeding a threshold comprises calculating the bolus amount further based on the active amount of the medicament.
However, in a differing embodiment, Haider teaches determining an active amount of the medicament in the user based at least in part on a dosage log of medicament delivery to the user (“The results of the injection, including dose amount, time of injection, and whether the injection was successful, are stored in a memory of the injection device 256 and transmitted to the hub 400” – Paragraph [0059]), and wherein the calculating the bolus amount of the medicament to administer to the user in response to the blood glucose level of the user exceeding a threshold comprises calculating the bolus amount further based on the active amount of the medicament (“the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment. Determinations may be based on both current and historical trend data.” – Paragraph [0045], examiner interprets the requirement of emergency medical treatment would need the determination of blood glucose level being above or below a normal limit, and the injection device would be able to reference back to the stored dose amount and time to determine an amount of insulin within a user when determining a requirement of an insulin dose).
Regarding Claim 37, modified Haider discloses the method of claim 34, further comprising outputting at least one notification regarding administering the calculated bolus amount of the medicament to the user via a user interface (“the injection device 256 may display a notification on a user interface of the injection device 256. The user interface may display a current glucose level, a notification that the glucose level is high or low, a notification that an insulin injection is required, or a notification that emergency medical assistance is required” – Paragraph [0045], Fig. 3A), and wherein the receiving the indication that the needle of the medicament injection pen is inserted into the user comprises receiving the indication via the user interface after outputting the at least one notification (“The user interface may also include a “prime” screen, which allows for entry and display of priming information. The prime screen may include a “needle positioning” field which can include information related to the position of the needle 309” – Paragraph [0058]).
Regarding Claim 38, modified Haider discloses the system of claim 34, wherein the bolus amount of the medicament is determined based at least in part on the analyte measurements of the user obtained from an analyte monitoring device (254, “The injection device 256 performs priming and bolus injection, based on a dose amount determined and transmitted to a controller in the smart pen injection device 256. One or more of the smart phone 252 and the injection device 256 can also perform data recording of glucose monitoring data received from the CGM 254” – Paragraph [0044]).
Regarding Claim 39, modified Haider discloses the method of claim 34, wherein the bolus amount of the medicament is delivered to the user without receiving user input setting the amount (“the injection device 256 can process data received from one or more of the CGM 254, the smart phone 252 and the other external devices to determine a status of a user. For example, the injection device 256 can determine high or low glucose readings, the requirement of an insulin dose, an insulin dosage amount, or the requirement of emergency medical treatment” – Paragraph [0045], “Once the dose is determined, the injection device 256 may inject the determined dose” – Paragraph [0047]).
Regarding Claim 40, modified Haider discloses the method of claim 37, wherein the medicament injection pen has a user interface (301-304, 306) for receiving user input causing the motorized pump to initiate delivery of the amount of the medicament to the user (Paragraph [0047]).
Regarding Claim 41, modified Haider discloses the method of claim 37, further comprising establishing wireless communication between the medicament injection pen and an external device (“The injection device 256 communicates wirelessly with the CGM 254 and/or the smart phone 252.” – Paragraph [0044]).
Regarding Claim 42, modified Haider discloses the method of claim 41, wherein the external devices is a glucose monitoring system (CGM 254) that is configured to obtain the blood glucose level of the user (“The appropriate bolus dosage is determined based on prior user information including body weight, target glucose, insulin-to-carbohydrate ratio, and the most recent blood glucose value received from CGM 254” – Paragraph [0048]).
Regarding Claim 45, modified Haider discloses the method of claim 37, wherein the calculating is performed by the medicament injection pen (“The injection device 256 can also include computing capabilities for determining insulin dose requirements” – Paragraph [0044]).
Regarding Claim 52, modified Haider discloses the method of claim 37.
Modified Haider does not expressly disclose wherein calculating the bolus amount includes dividing the bolus amount into a plurality of smaller doses that are to be administered at intervals determined by the memory and the processor.
However, Haider discloses that the injection device may process data regularly, semi-regularly, continuously, near continuously, or intermittently (Paragraph [0045]), the requirement for a dose is based on current and historical trend data (Paragraph [0045]), and that the injection device can include computing capabilities for determining insulin dose requirements (Paragraph [0044]).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by modified Haider wherein calculating the bolus amount includes dividing the bolus amount into a plurality of smaller doses that are to be administered at intervals determined by the memory and the processor as taught by Haider so that a user may inject a smaller dose, measure the blood glucose of the user, and determine if an additional dose is necessary (Paragraph [0045]).
Regarding Claim 53, modified Haider discloses the method of claim 52, further comprising receiving user input that causes the bolus amount to be divided into the plurality of smaller doses (“the dosage relevant information can be input into the smartphone 252” – Paragraph [0044]).
Claim(s) 21, 25-28, 44, and 46-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haider in view of Arnold et al. (Pub. No. US 20130245545 A1, herein Arnold).
Regarding Claim 21, modified Haider discloses the system of claim 13.
Modified Haider does not expressly disclose wherein the medicament injection pen includes a user interface that selectively activates a retraction mechanism to extend and retract the needle from a cap.
Arnold teaches wherein the medicament injection pen includes a user interface (1710) that selectively activates a retraction mechanism to extend and retract the needle (“the user presses the button 1710 and triggers the release of the needle 1750 (FIG. 17A) by the release of the spring 1740.” – Paragraph [0108]) from a cap (Paragraph [0108], Figs. 17A-17C).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system disclosed by modified Haider wherein the medicament injection pen includes a user interface that selectively activates a retraction mechanism to extend and retract the needle from a cap as taught by Arnold so that the injection needle may be protected (Arnold, Paragraph [0108]).
Regarding Claim 25, modified Haider discloses the system of claim 16.
Haider does not expressly disclose wherein the motorized pump includes a stepper motor in which each rotation is divided into a pre-defined number of steps.
Arnold teaches wherein the motorized pump (322) includes a stepper motor (“a driving mechanism including a motor 322 (e.g., stepper motor…” – Paragraph [0078]) in which each rotation is divided into a pre-defined number of steps (examiner interprets that the stepper motor is divided into a pre-defined number of steps per rotation).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system disclosed by modified Haider wherein the motorized pump includes a stepper motor in which each rotation is divided into a pre-defined number of steps as taught by Arnold so that insulin delivery is accurate (Arnold, Paragraph [0136]).
Regarding Claim 26, modified Haider in view of Arnold discloses the system of claim 25, wherein each of the steps of the stepper motor causes a known quantity of the medicament to be delivered via the needle (Arnold, Paragraph [0063], bolus amount, which is controlled by the processor, is delivered via motor 322 which may be a stepper motor in order to deliver a known amount of medicament).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system disclosed by modified Haider wherein each of the steps of the stepper motor causes a known quantity of the medicament to be delivered via the needle as taught by Arnold so that insulin delivery is accurate (Arnold, Paragraph [0136]).
Regarding Claim 27, modified Haider in view of Arnold discloses the system of claim 26, wherein the memory and the processor calculate the number of steps to rotate the stepper motor to extract the amount of medicament to be delivered via the needle (Arnold, Paragraph [0063], processor controls bolus amount delivery, processor able to calculate amount of steps required to deliver appropriate amount of medicament to needle).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system disclosed by modified Haider, wherein the memory and the processor calculate the number of steps to rotate the stepper motor to extract the amount of medicament to be delivered via the needle as taught by Arnold so that insulin delivery is accurate (Arnold, Paragraph [0136]).
Regarding Claim 28, modified Haider discloses the system of claim 13, wherein the medicament injection pen includes a medicament reservoir in which the medicament is housed (308).
Haider does not expressly disclose wherein the medicament injection pen is configured to identify a type of medicament in the medicament reservoir based on an indicator in the medicament reservoir.
Arnold teaches wherein the medicament injection pen is configured to identify a type of medicament in the medicament reservoir based on an indicator in the medicament reservoir (Paragraph [0089]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system disclosed by modified Haider wherein the medicament injection pen is configured to identify a type of medicament in the medicament reservoir based on an indicator in the medicament reservoir as taught by Arnold so that the system may not allow usage of a non-valid cartridge (Arnold, Paragraph [0089]).
Regarding Claim 44, modified Haider discloses the method of claim 37.
Haider does not expressly disclose further comprising receiving user input that selectively activates a retraction mechanism in the medicament injection pen to extend and retract the needle from a cap.
Arnold teaches receiving user input that selectively activates a retraction mechanism in the medicament injection pen to extend and retract the needle from a cap (Fig. 17A-17B, “the user presses the button 1710 and this triggers the release of the needle 1750” – Paragraph [0108]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by modified Haider further comprising receiving user input that selectively activates a retraction mechanism in the medicament injection pen to extend and retract the needle from a cap as taught by Arnold so that the injection needle is protected before injection (Arnold, Paragraph [0108]).
Regarding Claim 46, modified Haider discloses the method of claim 37.
Haider does not expressly disclose wherein the motorized pump includes a stepper motor in which each rotation is divided into a pre-defined number of steps.
Arnold teaches wherein the motorized pump (322) includes a stepper motor (“a driving mechanism including a motor 322 (e.g., stepper motor…” – Paragraph [0078]) in which each rotation is divided into a pre-defined number of steps (Examiner interprets that the stepper motor is divided into a pre-defined number of steps per rotation).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by Haider wherein the motorized pump includes a stepper motor in which each rotation is divided into a pre-defined number of steps as taught by Arnold so that insulin delivery is accurate (Arnold, Paragraph [0136]).
Regarding Claim 47, modified Haider in view of Arnold discloses the method of claim 46, wherein each of the steps of the stepper motor causes a known quantity of the medicament to be delivered via the needle (Arnold, Paragraph [0063], bolus amount, which is controlled by the processor, is delivered via motor 322 which may be a stepper motor in order to deliver a known amount of medicament).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by modified Haider wherein each of the steps of the stepper motor causes a known quantity of the medicament to be delivered via the needle as taught by Arnold so that insulin delivery is accurate (Arnold, Paragraph [0136]).
Regarding Claim 48, modified Haider in view of Arnold discloses the method of claim 47, further comprising calculating the number of steps to rotate the stepper motor to extract the amount of medicament to be delivered via the needle (Arnold, Paragraph [0063], processor controls bolus amount delivery, processor able to calculate amount of steps required to deliver appropriate amount of medicament to needle).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by modified Haider further comprising calculating the number of steps to rotate the stepper motor to extract the amount of medicament to be delivered via the needle as taught by Arnold so that insulin delivery is accurate (Arnold, Paragraph [0136]).
Regarding Claim 49, modified Haider discloses the method of claim 37.
Haider does not expressly disclose further comprising identifying a type of medicament in a medicament reservoir of the medicament injection pen based on an indicator in the medicament reservoir.
Arnold teaches identifying a type of medicament in a medicament reservoir of the medicament injection pen based on an indicator in the medicament reservoir (Paragraph [0089]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by modified Haider wherein identifying a type of medicament in a medicament reservoir of the medicament injection pen based on an indicator in the medicament reservoir as taught by Arnold so that the system may not allow usage of a non-valid cartridge (Arnold, Paragraph [0089]).
Claim(s) 30, 31, 50, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haider in view of Davis et al. (Pub. No. US 20170220750 A1, herein Davis).
Regarding Claim 30, modified Haider discloses the system of claim 13.
Modified Haider does not expressly disclose wherein the medicament injection pen includes a medicament sensor for measuring a systemic level of the medicament in the user.
Davis teaches a medicament sensor (“A continuous direct insulin sensor” – Paragraph [0205]) for measuring a systemic level of the medicament in the user (Paragraphs [0205], [0206]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system disclosed by modified Haider wherein the medicament injection pen includes a medicament sensor for measuring a systemic level of the medicament in the user as taught by Davis so that a user may monitor how much insulin has been administered (Davis, Paragraph [0205]).
Regarding Claim 31, modified Haider in view of Davis discloses the system of claim 30, wherein the medicament injection pen includes a safety module (Haider, “a safety feature to shutoff the delivery system” – Paragraph [0066]) for preventing medicament delivery based on medicament measurements from the medicament sensor (Haider, Paragraph [0066]).
Regarding Claim 50, modified Haider discloses the method of claim 37.
Haider does not expressly disclose further comprising receiving medicament measurements data from a medicament sensor, the medicament measurements indicating a systemic level of the medicament in the user.
Davis teaches receiving medicament measurements data from a medicament sensor (“A continuous direct insulin sensor” – Paragraph [0205]), the medicament measurements indicating a systemic level of the medicament in the user (“continuous direct insulin sensor may be employed to measure the amount of insulin that is within a patient” – Paragraph [0205]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by modified Haider further comprising receiving medicament measurements data from a medicament sensor, the medicament measurements indicating a systemic level of the medicament in the user as taught by Davis so that a user may monitor how much insulin has been administered (Davis, Paragraph [0205]).
Regarding Claim 51, modified Haider discloses the method of claim 50, further comprising preventing medicament delivery based on the medicament measurements from the medicament sensor (Davis, “This detector can be used as an alert or as a failsafe to shut off a pump or an artificial pancreas” – Paragraph [0205]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the method disclosed by modified Haider further comprising preventing medicament delivery based on the medicament measurements from the medicament sensor as taught by Davis so that if too much insulin is administered at once, the medicament sensor is able to detect hypoglycemia (Davis, Paragraph [0205]).
Response to Arguments
Applicants argument filed 07/22/2026 have been fully considered.
In regards to Applicants argument:
“Claim 51 has been amended to depend from claim 50 rather than claim 20. This amendment corrects the dependency issue identified in the Office Action, because claim 50 is a method claim reciting receipt of medicament measurement data from a medicament sensor, and claim 51 further recites preventing medicament delivery based on those medicament measurements. Accordingly, withdrawal of the § 112(b) rejection is respectfully requested.”
This argument is persuasive and the previous 112(b) rejection for claim 51 has been withdrawn. The Examiner thanks Applicant for correcting a similar issue in claims 38 and 39.
In regards to Applicants argument:
“Independent claims 1, 13, and 34 have also been amended to clarify the pen-local, user-mediated dosing workflow recited by the claims… Accordingly, Haider does not anticipate independent claims 1, 13, and 34, or the claims depending therefrom, and withdrawal of the § 102 rejection is respectfully requested.”
This argument is persuasive and the § 102 rejection for independent claims 1, 13, and 34 has been withdrawn. However, upon further search and consideration, a new ground of rejection is made in view of Haider.
In regards to Applicants argument:
“Claims 3, 12, and 36 stand rejected under 35 U.S.C. § 103 as allegedly obvious over Haider. Claim 12 has been cancelled. Applicant traverses this rejection as follows.”
This argument is persuasive and the previous § 103 rejection for claims 3 and 36 has been withdrawn. However, a new ground of rejection is made for independent claims 1, 13, and 34 in view of Haider.
In regards to Applicants argument:
“Claims 21, 25-28, 44, and 46-49 stand rejected under 35 U.S.C. § 103 as allegedly obvious over Haider in view of Arnold et al., US PGP 2013/0245545 (hereinafter "Arnold"). Applicant traverses this rejection as follows.”
This argument is persuasive and the previous § 103 rejection for claims 21, 25-28, 44, and 46-49has been withdrawn. However, a new ground of rejection is made for independent claims 1, 13, and 34 in view of Haider.
In regards to Applicants argument:
“Claims 30, 31, 50, and 51 stand rejected under 35 U.S.C. § 103 as allegedly obvious over Haider in view of Davis. Applicant traverses this rejection as follows.”
This argument is persuasive and the previous § 103 rejection for claims 30, 31, 50, and 51 has been withdrawn. However, a new ground of rejection is made for independent claims 1, 13, and 34 in view of Haider.
In regards to Applicants argument:
“The dependent claims depend from independent claims 1, 13, and 34, respectively, and are therefore allowable for the reasons discussed in support of claims 1, 13, and 34 above and also in view of each dependent claim's novel and non-obvious combination of features. For at least these reasons, Applicant requests that the rejection of the dependent claims be withdrawn.”
This argument is persuasive and the previous rejection for the claims that depend from claims 1, 13, and 34 have been withdrawn. However, upon further search and consideration, a new ground of rejection is made in view of Haider.
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 Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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