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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 6-8, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2019/0180856 to Aradottir et al. (“Aradottir”) in view of U.S. Patent Publication No. 2013/0345664 to Beck et al. (“Beck”), and U.S. Patent Publication No. 2011/0275986 to Bashan et al. (“Bashan”).
Regarding claim 1, Aradottir teaches a drug administration system (48) comprising a drug administration device (Fig. 1) including a drug holder and a dispensing mechanism ([0062]), memory (192/290), a processor (274), and a communications interface (106) configured to communicate with a communications interface (200) of a computer system (250, also Fig. 2), and wherein the drug administration device is configured to deliver a drug through the dispensing mechanism to a patient in accordance with a first drug dosing scheme (Fig. 4A, 408, first data set), the first drug dosing scheme including a collection of one more drug dosing parameters associated with delivery of the drug, the one or more drug dosing parameters including drug delivery rate, drug delivery duration, drug delivery frequency, and timing of drug delivery (408, the timestamp represents at least duration and/or frequency) then determine a second drug dosing scheme for delivering the drug from the drug administration device to the patient (434, short acting insulin medicament dosage for the prospective meal event) and deliver the drug through the dispensing mechanism to the patient in accordance with the second drug dosing scheme (434), but does show the at least one sensor, the type of dosing data used for the second drug dosing scheme and does not explicitly mention a drug holder, although one of ordinary skill would understand that an insulin pen inherently includes a drug holder.
Beck teaches at least one sensor (540) configured to obtain sensor data and communicate the sensor data to the drug administration device, the at least one sensor comprising an environment sensor configured to obtain sensor data relating to humidity of an environment in which the drug administration device is present ([0045]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a humidity sensor with drug administration system of Aradottir as taught by Beck to yield the predictable result of providing a more accurate blood glucose level, as environmental factors such as humidity affect blood glucose levels, which are necessary for calculating insulin delivery dosages ([0045]).
Beck also teaches dosing data from a computer system comprising at least one of patient age, patient weight, urine pH of the patient, patient temperature, or the existence of other disease states ([0045], body temperature). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated temperature in calculating the bolus dosage in Aradottir as taught by Beck to yield the predictable result of providing a more accurate blood glucose level, as environmental factors such as temperature affect blood glucose levels, which are necessary for calculating insulin delivery dosages ([0045]). Once combined, since the drug delivery based on the second drug dosing scheme uses the humidity data, the humidity or sensor data would inherently be obtained at least during and/or after the delivery of the drug according to the first drug dosing scheme, since the drug delivery using the second dosing scheme occurs after the delivery of the drug according to the first drug dosing scheme.
Bashan teaches a drug administration device (10, Fig. 10) including a drug holder ([0066], cartridges). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a drug holder in the insulin pen of Aradottir, because insulin pens are understood in the art to include a drug holder and Bashan simply shows an example of a drug holder in an insulin pen, the inclusion of which would yield the predictable result of providing a drug source to be administered upon activation of the insulin pen.
Regarding claim 2, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, Aradottir further teaching the drug administration device being capable of determining the first drug dosing scheme for delivering the drug to the patient before utilizing the first drug dosing scheme when the drug is delivered from the drug administration device to the patient (the first drug dosing scheme cannot be administered/delivered without first being determined).
Regarding claim 6, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, Aradottir further teaching each of the first and second drug dosing schemes each specify at least drug delivery volume (both schemes include a bolus dosage and a bolus dosage is understood as a volume or drug dosage [0170]).
Regarding claim 7, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, Aradottir further teaching a patient monitoring sensor configured to obtain sensor data relating to a condition of the patient (glucose sensor 102-1).
Regarding claim 8, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, Aradottir further teaching at least one external sensor (glucose sensor P, Fig. 1) configured to obtain external sensor data and communicate the external sensor data to the computer system (sensors are connected to computer system 250) and wherein the second drug dosing scheme is further determined dependent on external sensor data from the computer system (multiple glucose sensors can be associated with a subject to provide the glucose levels [0066], that are eventually used for the bolus of the second drug dosing scheme).
Regarding claim 16, Aradottir, Beck, and Bashan teach the drug administration system of claim 2, Aradottir further teaching the first drug dosing scheme being determined dependent on dosing data communicated from the computer system (Fig. 4A, 408, each insulin record includes an amount of insulin).
Regarding claim 17, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, Aradottir further teaching the first and second drug dosing schemes specifying drug delivery volume (both dosing schemes include a bolus dosage and a bolus dosage is a delivery volume [0170]), and a value of one or more of the parameters in the first drug dosing scheme is different than a value of the corresponding parameter in the second drug dosing scheme (at least BG and Basal values are different for each of the first and second drug dosing schemes).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Aradottir, Beck, and Bashan as applied to claim 1 above, and further in view of U.S. 2016/0166768 to Edwards et al. (“Edwards”).
Regarding claim 9, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, but do not explicitly teach a second drug administration device. The details of the second drug administrative device are identical to that of the drug administrative device of claim 1, such as a communications interface (106) configured to communicate with the communications interface (200) of the computer system (250), at least one sensor (102-1) configured to obtain supplementary sensor data and communicate the supplementary sensor data to the drug administration device (Fig. 1) and wherein the second drug dosing scheme is further determined dependent on the supplementary sensor data ([0135], multiple sensors can be used to provided BG information to calculate the amount for the delivery according to the second drug dosing scheme) from the computer system as taught by Aradottir.
With regard to a second drug administrative device, Edwards teaches a second drug administration device ([0266] multiple medicament delivery devices) in a similar type of drug administrative system. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aradottir to have two drug administrative devices instead of one as taught by Edwards in order to manage insulin delivery or the delivery of other medicaments which can require daily, weekly, and/or monthly injections ([0266]).
Regarding claim 10, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, but does not explicitly teach a second administration device. The details of the second drug administration device are identical to that of the drug administrative device of claim 1, such as the communications interface (106) configured to communicate with the communications interface (200) of the computer system (250) as taught by Aradottir, Aradottir further teaching at least one user interface (278) configured to obtain supplementary user input data and communicate the supplementary user input data to the drug administration device ([0112]), the second drug dosing scheme is further determined dependent on the supplementary user input data ([0112], user input can be used for the bolus deliveries) from the computer system.
With regard to a second drug administrative device, Edwards teaches a second drug administration device ([0266] multiple medicament delivery devices) in a similar type of drug administrative system. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Aradottir to have two drug administrative devices instead of one as taught by Edwards in order to manage insulin delivery or the delivery of other medicaments which can require daily, weekly, and/or monthly injections ([0266]).
Regarding claim 11, Aradottir, Beck, Bashan and Edwards teach the drug administration system of claim 10, Aradottir further teaching at least one second sensor (102-P) configured to obtain supplementary sensor data and communicate the supplementary sensor data to the second drug administration device, and wherein the second drug dosing scheme ([0145]) is further determined dependent on the supplementary sensor data ([0135], multiple sensors can be used to provide BG information to calculate the delivery according to the second drug dosing scheme) from the computer system as taught by Aradottir.
Regarding claim 12, Aradottir, Beck, Bashan, and Edwards teach the drug administration system of claim 9, Aradottir further teaching a patient monitoring sensor (373) configured to obtain supplementary sensor data relating to a condition of a patient ([0098]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Aradottir in view of Beck and Bashan as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2018/0193564 to Dahmani.
Regarding claim 13, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, Aradottir further teaching the drug administration device being an autoinjector (insulin pen) and the first and second drug dosing schemes as shown above, but does not teach a parameter of a discharge nozzle advance depth.
Dahmani teaches a discharge nozzle advance depth of a discharge nozzle during delivery of the drug to the patient ([0114], the operating programs stores injection depth). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated injection depth as a parameter in the dosing schemes of Aradottir as taught by Dahmani because the optimal injection depth can be unique to the particular medicament ([0114]) and treatment optimization enhances patient treatment and care.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Aradottir in view of Beck and Bashan, as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2008/0152507 to Bohm.
Regarding claim 18, Aradottir, Beck, and Bashan teach the drug administration system of claim 1, but does not teach the claimed drug. Bohm teaches that injection systems used for insulin (abstract) can also be used for other drugs such as ketamine ([0028]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Aradottir and Bashan to use the drug ketamine as taught by Bohm in order to be able to deliver a variety of medically useful infusion liquids for various treatments such as anesthesia ([0028]).
Response to Arguments
Applicant’s arguments and amendments with respect to the claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments with respect to the 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn.
Applicant’s arguments and amendments with respect to the art rejections have been fully considered and are persuasive. The previous art rejections have been withdrawn. However, new art rejection in response to Applicant’s amendments have been made as shown above in view of Aradottir, Beck, and Bashan.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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