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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/12/2026 has been entered.
Response to Amendment
The Amendment filed 9/8/2025 has been entered. Claims 1-25 remain pending in the application.
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.
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.
Claim(s) 1-6, 11-16, 21, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mazlish et al. (US 2017/0189614 A1) in view of Abraham et al. (US 2017/0049386 A1).
Regarding claims 1 and 21, Mazlish discloses a controller 5 (figures 1A, 1B) for operating a drug delivery device 4, comprising:
a processor (paragraph 0044, lines 1-2, “processor”); and
a memory (paragraph 0044, lines 2-17) storing instructions that, when executed by the processor, operate the controller to:
determine a plurality of dosage clusters (paragraph 0075, lines 1-22, paragraph 0079) for a patient based on drug dosage patient information,
determine an adjustment profile (paragraph 0075, lines 22-31) for each of the dosage clusters,
determine a current cluster (paragraph 0050) for a dosage cycle,
determine an adjusted dosage (paragraph 0075, lines 22-31) for the dosage cycle by applying the adjustment profile to a default dosage, and
provide a signal (paragraph 0042, lines 12-16) to the drug delivery device to deliver the adjusted dosage to the patient for the dosage cycle but is silent regarding determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period, wherein each dosage cluster represents a segmentation of a time period into clusters representing consistent temporal categories.
However, Abraham teaches a method of determining personalized event detection including determine (paragraph 0044, dosage clusters being formed by “meal segment” and “non-meal segment”) a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period, wherein each dosage cluster (paragraph 0044, dosage clusters being formed by “meal segment” and “non-meal segment”) represents a segmentation of a time period into clusters representing consistent temporal categories for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify determine a plurality of dosage clusters of Mazlish to incorporate determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period wherein each dosage cluster represents a segmentation of a time period into clusters representing consistent temporal categories as taught by Abraham for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Regarding claim 2, Mazlish discloses an automatic insulin delivery device (paragraph 0063).
Regarding claim 3, Mazlish discloses the delivery device 4 configured to deliver a drug comprising one of a hormone, a protein, a chemotherapy drug, a medication, glucagon, a glucagon-like peptide, or insulin (paragraph 0063, lines 1-7).
Regarding claim 4, Mazlish discloses the instructions, when executed by the processor, to operate the controller to determine the plurality of clusters based on at least one of a time period or a cluster criterion (paragraph 0075, lines 22-27, “timeframe”).
Regarding claim 5, Mazlish discloses the time period comprising one of a week, a month, or a year (paragraph 0087, lines 4-6).
Regarding claim 6, Mazlish discloses the plurality of clusters segmented based on days of the week (paragraph 0087, lines 4-6).
Regarding claim 11, Mazlish discloses a method (paragraph 0075) for operating a drug delivery device 4, comprising via a processor (paragraph 0044, lines 1-2, “processor”) of a controller 5 (figures 1A, 1B):
determining a plurality of dosage clusters (paragraph 0075, lines 1-22, paragraph 0079) for a patient based on drug dosage patient information,
determining an adjustment profile (paragraph 0075, lines 22-31) for each of the dosage clusters,
determining a current cluster (paragraph 0050) for a dosage cycle,
determining an adjusted dosage (paragraph 0075, lines 22-31) for the dosage cycle by applying the adjustment profile to a default dosage, and
providing a signal (paragraph 0042, lines 12-16) to the drug delivery device to deliver the adjusted dosage to the patient for the dosage cycle but is silent regarding determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period.
However, Abraham teaches a method of determining personalized event detection including determine (paragraph 0044, dosage clusters being formed by “meal segment” and “non-meal segment”) a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify determine a plurality of dosage clusters of Mazlish to incorporate determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period as taught by Abraham for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Regarding claim 12, Mazlish discloses an automatic insulin delivery device (paragraph 0063).
Regarding claim 13, Mazlish discloses the drug delivery device 4 configured to deliver a drug comprising one of a hormone, a protein, a chemotherapy drug, a medication, glucagon, a glucagon-like peptide, or insulin (paragraph 0063, lines 1-7).
Regarding claim 14, Mazlish discloses the instructions, when executed by the processor, to operate the controller to determine the plurality of clusters based on at least one of a time period or a cluster criterion (paragraph 0075, lines 22-27, “timeframe”).
Regarding claim 15, Mazlish discloses the time period comprising one of a week, a month, or a year (paragraph 0087, lines 4-6).
Regarding claim 16, Mazlish discloses the plurality of clusters segmented based on days of the week (paragraph 0087, lines 4-6).
Regarding claim 22, Mazlish is silent regarding wherein the consistent temporal categories are selected based on the analyzed data rather than being predetermined.
However, Abraham teaches wherein the consistent temporal categories are selected based on the analyzed data rather than being predetermined (paragraph 0044, figure 2, element “206”) for the purpose of accurately classifying the data into an appropriate category for performing medical operations (paragraph 0044).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the controller of Mazlish to incorporate wherein the consistent temporal categories are selected based on the analyzed data rather than being predetermined as taught by Abraham for the purpose of accurately classifying the data into an appropriate category for performing medical operations (paragraph 0044).
Regarding claim 24, Mazlish discloses wherein the plurality of dosage clusters are iteratively updated at predetermined periodic intervals (paragraph 0088).
Claims 1-4, 7, 11-14 and 17 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Schaible et al. (US 2016/0082187 A1) in view of Abraham et al. (US 2017/0049386 A1).
Regarding claim 1, Schaible discloses a controller 104 (figure 2) for operating a drug delivery device 102, comprising:
a processor 286; and
a memory 240 (paragraph 0095) storing instructions that, when executed by the processor 286, operate the controller to:
determine a plurality of dosage clusters (paragraph 0053, dose data for “a dose period”) for a patient based on drug dosage patient information,
determine an adjustment profile (paragraph 0055) for each of the dosage clusters,
determine a current cluster (paragraph 0104) for a dosage cycle,
determine an adjusted dosage (paragraph 0105) for the dosage cycle by applying the adjustment profile to a default dosage, and
provide a signal (paragraph 0047, lines 5-10) to the drug delivery device to deliver the adjusted dosage to the patient for the dosage cycle but is silent regarding determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period.
However, Abraham teaches a method of determining personalized event detection including determine (paragraph 0044, dosage clusters being formed by “meal segment” and “non-meal segment”) a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify determine a plurality of dosage clusters of Mazlish to incorporate determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period as taught by Abraham for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Regarding claim 2, Schaible discloses comprising an automatic insulin delivery device (paragraph 0047).
Regarding claim 3, Schaible discloses the drug delivery device 102 configured to deliver a drug comprising one of a hormone, a protein, a chemotherapy drug, a medication, glucagon, a glucagon-like peptide, or insulin (paragraph 0047, “insulin”).
Regarding claim 4, Schaible discloses, the instructions, when executed by the processor, to operate the controller to determine the plurality of clusters based on at least one of a time period or a cluster criterion (paragraph 0052).
Regarding claim 7, Schaible discloses the at least one cluster criterion comprising a dosage deviation (paragraph 0055, lines 1-3, paragraph 0066, lines 10-12) in drug dosages between portions of a time period.
Regarding claim 11, Schaible discloses a method (figures 3A, 3B) for operating a drug delivery device 102, comprising, via a processor 286 of a controller 104 (figure 2):
determining a plurality of dosage clusters (paragraph 0053, dose data for “a dose period”) for a patient based on drug dosage patient information,
determining an adjustment profile (paragraph 0055) for each of the dosage clusters,
determining a current cluster (paragraph 0104) for a dosage cycle,
determining an adjusted dosage (paragraph 0105) for the dosage cycle by applying the adjustment profile to a default dosage, and
providing a signal (paragraph 0047, lines 5-10) to the drug delivery device to deliver the adjusted dosage to the patient for the dosage cycle but is silent regarding determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period.
However, Abraham teaches a method of determining personalized event detection including determine (paragraph 0044, dosage clusters being formed by “meal segment” and “non-meal segment”) a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify determine a plurality of dosage clusters of Mazlish to incorporate determine a plurality of dosage clusters by analyzing historical drug dosage data to identify temporal patterns and segmenting a time period into clusters based on dosage deviations between portions of the time period as taught by Abraham for the purpose of accurately identifying the interested physiological event in the patient’s body and taking appropriate steps to accurately regulate the analyte level in the patient’s blood stream (paragraph 0133).
Regarding claim 12, Schaible discloses comprising an automatic insulin delivery device (paragraph 0047).
Regarding claim 13, Schaible discloses the drug delivery device 102 configured to a drug comprising one of a hormone, a protein, a chemotherapy drug, a medication, glucagon, a glucagon-like peptide, or insulin (paragraph 0047, “insulin”).
Regarding claim 14, Schaible discloses the instructions, when executed by the processor, to operate the controller to determine the plurality of clusters based on at least one of a time period or a cluster criterion (paragraph 0052).
Regarding claim 17, Schaible discloses the at least one cluster criterion comprising a dosage deviation (paragraph 0055, lines 1-3, paragraph 0066, lines 10-12) in drug dosages between portions of a time period.
Claim(s) 8, 9, 10, 18, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schaible et al. (US 2016/0082187 A1) in view of Abraham et al. (US 2017/0049386 A1) and further in view of Desborough et al. (US 2017/0203038 A1).
Regarding claim 8, Schaible/Abraham (hereinafter referred as “modified Schaible”) discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Schaible further discloses the time period comprising a month (paragraph 0054, “30 days”) and the dosage deviation comprising difference (paragraph 0066, lines 3-18) in a dose of the drug between consecutive days of the week.
Modified Schaible is silent regarding disclosing the difference being represented in the form of a percentage.
However, Desborough teaches a design of adjusting insulin delivery rates comprising determining the difference between insulin actually delivered during the first diurnal time period and the amount dictated by the baseline basal insulin rate (paragraph 0034) wherein the difference is represented in the form of a percentage (paragraph 0034) for the purpose of using a well-known alternative form of presenting the different (paragraph 0034).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the difference representation of modified Schaible to incorporate a percentage as taught by Desborough for the purpose of using a well-known alternative form of presenting the different (paragraph 0034).
Regarding claim 9, modified Schaible discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Schaible is silent regarding the percentage difference comprising about 10% to about 100%.
There is no evidence of record that establishes that changing the percentage difference between about 10% to about 100% would result in a difference in function of the Schaible device. Further, one having ordinary skill in the art, being faced with modifying the controller to include a difference would have a reasonable expectation of success in making such modification. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the difference “may” be within the claimed range, and offering other acceptable ranges (paragraph 0080) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the difference of modified Schaible to have the difference between 10% and 100% as an obvious matter of design choice within the skill of the art.
Regarding claim 10, modified Schaible discloses the claimed invention substantially as claimed, as set forth above in claim 1. Schaible further discloses, the instructions, when executed by the processor, to operate the controller to determine the adjustment profile for each of the dosage clusters based on one or more of: an overall drug dosage (paragraph 0052, “long cycle”) and a cluster dosage (paragraph 0052, “dose period”), or (a cluster dosage mean)/(an overall drug dosage mean).
Modified Schaible is silent regarding an overall drug dosage and a cluster dosage being an overall drug dosage mean and a cluster dosage mean.
However, Desborough teaches representing dosage in the form of a mean (paragraph 0093, lines 14-19, “average total daily insulin”, “average basal rate”) for the purpose of using a well-known alternative form of presenting the data (paragraph 0093, lines 14-19).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the representation of the overall drug dosage and a cluster dosage of modified Schaible to incorporate an overall drug dosage mean and a cluster dosage mean as taught by Desborough for the purpose of using a well-known alternative form of presenting the data (paragraph 0093, lines 14-19).
Regarding claim 18, modified Schaible discloses the claimed invention substantially as claimed, as set forth above in claims 11 and 17. Schaible further discloses the time period comprising a month (paragraph 0054, “30 days”) and the dosage deviation comprising difference (paragraph 0066, lines 3-18) in a dose of the drug between consecutive days of the week.
Modified Schaible is silent regarding disclosing the difference being represented in the form of a percentage.
However, Desborough teaches a design of adjusting insulin delivery rates comprising determining the difference between insulin actually delivered during the first diurnal time period and the amount dictated by the baseline basal insulin rate (paragraph 0034) wherein the difference is represented in the form of a percentage (paragraph 0034) for the purpose of using a well-known alternative form of presenting the different (paragraph 0034).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the difference representation of modified Schaible to incorporate a percentage as taught by Desborough for the purpose of using a well-known alternative form of presenting the difference (paragraph 0034).
Regarding claim 19, modified Schaible discloses the claimed invention substantially as claimed, as set forth above in claims 11 and 17. Schaible further discloses the deviations (paragraph 0055) but is silent regarding the percentage difference comprising about 10% to about 100%.
As explained in the rejection of claim 9 above, Desborough discloses the deviation being presented in a percentage form. Therefore, modified Shaible modified in view of Desborough would present the difference in the form of percentage. Since claim only recites about 10% to about 100%, any difference converted into percentage when modifying Schaible in view of Desborough would result in having a percentage that is about 10% to about 100%.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the difference representation of modified Schaible to incorporate a percentage as taught by Desborough for the purpose of using a well-known alternative form of presenting the difference (paragraph 0034).
Regarding claim 20, modified Schaible discloses the claimed invention substantially as claimed, as set forth above in claim 11. Schaible further discloses, the instructions, when executed by the processor, to operate the controller to determine the adjustment profile for each of the dosage clusters based on one or more of: an overall drug dosage (paragraph 0052, “long cycle”) and a cluster dosage (paragraph 0052, “dose period”), or (a cluster dosage mean)/(an overall drug dosage mean).
Modified Schaible is silent regarding an overall drug dosage and a cluster dosage being an overall drug dosage mean and a cluster dosage mean.
However, Desborough teaches representing dosage in the form of a mean (paragraph 0093, lines 14-19, “average total daily insulin”, “average basal rate”) for the purpose of using a well-known alternative form of presenting the data (paragraph 0093, lines 14-19).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the representation of the overall drug dosage and a cluster dosage of modified Schaible to incorporate an overall drug dosage mean and a cluster dosage mean as taught by Desborough for the purpose of using a well-known alternative form of presenting the data (paragraph 0093, lines 14-19).
Response to Arguments
Applicant’s arguments with respect to claim 1 and 11 have been considered but are moot because the arguments do not apply in view of the present rejection.
Allowable Subject Matter
Claims 23 and 25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 23, the closest prior art of record, Mazlish et al. (US 2017/0189614 A1) in view of Abraham et al. (US 2017/0049386 A1), is silent regarding analyzing the drug dosage patient information … segmenting the time period into the plurality of clusters based on the identified dosage deviations” in combination with other claimed limitations of claim 23.
Regarding claim 25, the closest prior art of record, Mazlish et al. (US 2017/0189614 A1) in view of Abraham et al. (US 2017/0049386 A1), is silent regarding wherein determining the plurality of dosage clusters comprises identifying transitions in mean total daily insulin requirements in combination with other claimed limitations of claim 25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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