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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US Publication No. 2023/0285670), hereinafter, Lee.
Regarding Claim 1, Lee discloses a method for updating an infusion control parameter comprising: obtaining at least one of an infusion record collection and medical advice information in an infusion pump (basal portion value is used as a parameter for adapting and periodically updating drug delivery to a user in figs. 14 and 15A-15B; para [0038]) satisfying at least one selected analysis rule, wherein the infusion record collection comprises at least one drug name and a corresponding infusion record (basal portion value, as a parameter, aids in determination of delivery of insulin for user and is based on historical medicament delivery data; para [0037-0038] and [0043]); the infusion record further comprises at least one infusion control parameter, and the medical advice information comprises at least one drug name and a corresponding infusion control parameter (medicament may be insulin wherein the dosage may be determined using an adjustment restriction that may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]);
determining an alternative control parameter corresponding to at least one drug name by analyzing the at least one of the obtained infusion record and the medical advice information (new basal ratio is an alternative control parameter value determined according to old basal ratio of insulin delivery and an adjustment factor and then compared to upper and lower threshold level in fig. 6B; upper and lower threshold levels are set based on medical advice information);
updating a drug database (storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]) stored in the infusion pump according to the obtained alternative control parameters corresponding to the at least one drug name (basal portion value is used as a parameter for adapting and periodically updating drug delivery to a user in figs. 14 and 15A-15B; determination of delivery of insulin for user is based on historical medicament delivery data; para [0037-0038]); and
selectively controlling the infusion pump according to the infusion control parameter and the alternative control parameter (pump 113 drives medicament delivery to user 108; processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042] and [0048]).
Regarding claim 2, Lee discloses the method of claim 1, wherein the step of analyzing the at least one of the obtained infusion record and the medical advice information to obtain the alternative control parameter corresponding to at least one drug name comprises: determining the alternative control parameter corresponding to the at least one drug name by analyzing at least one of a change in and a frequency of use of the at least one infusion control parameter corresponding to at least one the drug name in the at least one of the obtained infusion record and the medical advice information (intervals and degree of adaptivity of alternative control parameter may be modulated, controlled by a scaling factor, by controlling the rate of adaptivity to small increments each time the basal ratio is updated in figs. 12-14; para [0037-0038], [0084-0085]).
Regarding claim 3, Lee discloses the method of claim 1, wherein the step of analyzing the at least one of the obtained infusion record and the medical advice information to obtain the alternative control parameter corresponding to at least one drug name comprises: determining the alternative control parameter corresponding to the at least one drug name by analyzing a difference between the at least one infusion control parameter in the infusion record corresponding to at least one drug name (storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]), and the infusion control parameter corresponding to the drug name in the at least one of the medical advice information and the infusion control parameter corresponding to the drug name stored in the infusion pump (medicament may be insulin wherein the dosage may be determined using an adjustment restriction that may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]; storage 114 includes both primary and secondary memory, random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage, or the like; storage 114 hold histories 111 for user; para [0043]).
Regarding claim 4, Lee discloses the method of claim 1, wherein the step of analyzing the at least one of the obtained infusion record and the medical advice information to obtain the alternative control parameter corresponding to at least one drug name comprises: determining the alternative control parameter corresponding to the at least one drug name by analyzing a difference between the infusion control parameter in the medical advice information (Lee analyzes differences involving input parameters, adjustment factors, relative to insulin delivery in fig. 6B; adjustment restriction, or medically advised limits, may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]) corresponding to the at least one drug name and the infusion control parameter corresponding to the drug name stored in the infusion pump (storage 114 hold histories 111 for user; para [0043]).
Regarding claim 5, Lee discloses the method of claim 1, wherein the infusion record comprises at least one of patient information and infusion consumable information; the alternative control parameter is associated with one or more of a patient type, a disease type, a medical history, a treatment history, a departmental information, a consumable type, a consumable model, and a consumable specification (basal portion value is used as a parameter for adapting and periodically updating drug delivery to a user in figs. 14 and 15A-15B; determination of delivery of insulin for user is based on historical medicament delivery data; para [0037-0038]).
Regarding claim 6, Lee discloses the method of claim 1, wherein the selected analysis rule comprises at least one of an infusion time interval, an infused drug name, department information, a patient type, a disease type, a number of infusions, a frequency of changes to the infusion control parameter, a consumable type, a consumable model, a consumable specification, and a user trigger (analysis based on medicament usage history, preceding intervals, to inform medicament dosages for time horizon in figs. 14 and 15A-15B; para [0084]).
Regarding claim 7, Lee discloses the method of claim 1, wherein after the step of analyzing the at least one of the obtained infusion records and medical advice information to obtain the alternative control parameters corresponding to the at least one drug name, and further comprising: outputting the obtained at least one drug name and its corresponding infusion control parameter (output display may confirm change in dosage (basal delivery amount) as determined by processor 110 or management device 104 according to updated basal ratio and basal portion value of insulin being delivered in figs. 1, 9; para [0042], [0051]).
Regarding claim 9, Lee discloses the method of claim 1, further comprising: outputting the obtained at least one drug name and its corresponding alternative control parameter to one or more of an input-output device, other infusion pumps, a workstation, and a central station (there may be communications links with one or more devices physically separated from medicament delivery device 102 in including management device 104, sensors 106, smartwatch 130, fitness monitor 132 or another variety of device 134 in fig. 1; para [0045-0046]).
Regarding claim 10, Lee discloses an infusion pump (medicament delivery device 102 in fig. 1) comprising a driving device (medicament delivery device 102 expels medicament from a reservoir 112 to deliver medicament to the user 108 using pump 113 via a fluid path in fig. 1; para [0044]) , a casing (medicament delivery device 102 may include one or more housings for housing its various components; para[0044]), a storage device arranged in the casing (storage 114 includes both primary and secondary memory, random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage, or the like; storage 114 hold histories 111 for user; para [0043]), and a controller configured to control the driving device (processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042]) to push out a liquid in an infusion consumable connected to the infusion pump (fluid path includes tubing coupling a cannula to the reservoir 112 using and through which pump 113 drives medicament delivery to user 108; para [0044]), wherein the controller is configured:
to determine at least one of an infusion record collection and medical advice information in an infusion pump satisfying at least one selected analysis rule, wherein the infusion record collection comprises at least one drug name and a corresponding infusion record (basal portion value, as a parameter, aids in determination of delivery of insulin for user and is based on historical medicament delivery data; para [0037-0038] and [0043]); the infusion record further comprises at least one infusion control parameter, and the medical advice information comprises at least one drug name and a corresponding infusion control parameter (medicament may be insulin wherein the dosage may be determined using an adjustment restriction that may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]);
to update a drug database (storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]) stored in the infusion pump according to the obtained alternative control parameters corresponding to the at least one drug name (basal portion value is used as a parameter for adapting and periodically updating drug delivery to a user in figs. 14 and 15A-15B; determination of delivery of insulin for user is based on historical medicament delivery data; para [0037-0038]);
and to selectively control operation of the infusion pump according to the infusion control parameter and the alternative control parameter (pump 113 drives medicament delivery to user 108; processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042] and [0048]).
Regarding claim 11, Lee discloses the device of claim 10, wherein the controller is configured to analyze the at least one obtained infusion record and medical advice information to obtain the alternative control parameter corresponding to at least one drug name by: analyzing at least one of a change of and frequency of use of the at least one infusion control parameter corresponding to at least one the drug name in the at least one of the obtained infusion record and medical advice information, to obtain the alternative control parameter corresponding to the at least one drug name (intervals and degree of adaptivity of alternative control parameter may be modulated, controlled by a scaling factor, by controlling the rate of adaptivity to small increments each time the basal ratio is updated in figs. 12-14; para [0037-0038], [0084-0085]);
or, analyzing a difference between the at least one infusion control parameter in the infusion record corresponding to at least one drug name, and the infusion control parameter corresponding to the drug name in the at least one medical advice information and the infusion control parameter corresponding to the drug name stored in the infusion pump to obtain the alternative control parameter corresponding to the at least one drug name (The storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]);
or, analyzing a difference between the infusion control parameter in the medical advice information corresponding to the at least one drug name and the infusion control parameter corresponding to the drug name stored in the infusion pump to obtain the alternative control parameter corresponding to the at least one drug name (Lee analyzes differences involving input parameters, adjustment factors, relative to insulin delivery in fig. 6B; adjustment restriction, or medically advised limits, may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]).
Regarding claim 12, Lee discloses the device of claim 10, wherein the controller is configured to analyze the at least one obtained infusion record and medical advice information (processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042]) to obtain the alternative control parameter corresponding to at least one drug name by analyzing a difference between the at least one infusion control parameter in the infusion record corresponding to at least one drug name (The storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]), and the infusion control parameter corresponding to the drug name in the at least one medical advice information and the infusion control parameter corresponding to the drug name stored in the infusion pump to obtain the alternative control parameter corresponding to the at least one drug name (medicament may be insulin wherein the dosage may be determined using an adjustment restriction that may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]; storage 114 includes both primary and secondary memory, random access memory (RAM), read only memory (ROM), optical storage, magnetic storage, removable storage media, solid state storage, or the like; storage 114 hold histories 111 for user; para [0043]).
Regarding claim 13, Lee discloses the device of claim 10, wherein the controller is configured to analyze the at least one obtained infusion record and medical advice information (processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042]) to obtain the alternative control parameter corresponding to at least one drug name by analyzing a difference between the infusion control parameter in the medical advice information corresponding to the at least one drug name and the infusion control parameter corresponding to the drug name stored in the infusion pump to obtain the alternative control parameter corresponding to the at least one drug name (Lee analyzes differences involving input parameters, adjustment factors, relative to insulin delivery in fig. 6B; adjustment restriction, or medically advised limits, may limit a difference between the previous basal ratio and the new basal ratio to a predetermined fixed amount; may be a scaling factor that scales the adjustment in figs. 3 and 11; para [0005], [0057] and [0062]).
Regarding claim 14, Lee discloses the device of claim 10, wherein the infusion record comprises at least one of patient information and infusion consumable information; the alternative control parameter is associated with at least one patient type, a disease type, a medical history, a treatment history, a departmental information, a consumable type, a consumable model, and a consumable specification (basal portion value is used as a parameter for adapting and periodically updating drug delivery to a user in figs. 14 and 15A-15B; determination of delivery of insulin for user is based on historical medicament delivery data; para [0037-0038]).
Regarding claim 15, Lee discloses the device of claim 10, wherein the selected analysis rule comprises at least one of an infusion time interval, an infused drug name, department information, a patient type, a disease type, a number of infusions, a frequency of changes to the infusion control parameter, a consumable type, a consumable model, a consumable specification, and a user trigger (analysis based on medicament usage history, preceding intervals, to inform medicament dosages for time horizon in figs. 14 and 15A-15B; para [0084]).
Regarding claim 16, Lee discloses the device of claim 10, wherein the controller is further configured to analyze the at least one of the obtained infusion records and the medical advice information (processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042]) to obtain the alternative control parameters corresponding to the at least one drug name and to output the obtained at least one drug name and its corresponding infusion control parameter (output display may confirm change in dosage (basal delivery amount) as determined by processor 110 or management device 104 according to updated basal ratio and basal portion value of insulin being delivered in figs. 1, 9; para [0042], [0051]).
Regarding claim 18, Lee discloses the device of claim 10, wherein the controller is further configured to output the obtained at least one drug name and its corresponding alternative control parameter to one or more of an input-output device, other infusion pumps, a workstation, and a central station, after analyzing the at least one of the obtained the infusion record and the medical advice information to obtain the alternative control parameter corresponding to the at least one drug name (there may be communications links with one or more devices physically separated from medicament delivery device 102 in including management device 104, sensors 106, smartwatch 130, fitness monitor 132 or another variety of device 134 in fig. 1; para [0045-0046]).
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.
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 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, as applied to claims 1 and 10, in view of Desborough (Publication No. 2017/0203039), hereinafter, Desborough.
Regarding claim 8, Lee discloses the method of claim 1, comprising the use of the alternative control parameter corresponding to the at least one drug name in the drug database (storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]).
Lee does not, however, disclose outputting an alarm message when detecting that the frequency of use of the alternative control parameter is lower than the frequency threshold.
Desborough teaches outputting an alarm message when detecting that the frequency of use of the alternative control parameter is lower than a set frequency threshold (Desborough teaches that bolus dosages can be more frequently dispensed based on calculations and system monitoring of usage and can provide an alert to the user (via the user interface 220 or via the mobile computing device 60) so that the user can manually initiate the administration of a selected bolus dosage of insulin to correct for the rapid increase in blood glucose level; para [0178]).
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 medicament delivery device of Lee to output an alarm message when detecting that the frequency of use of the alternative (updated) control parameter corresponding to the at least one drug name in the drug database is lower than a set frequency threshold, as taught by Desborough, in order to alert the user or clinician when the updated parameter is not being effectively utilized and to prompt corrective action.
Regarding claim 8, Lee discloses the device of claim 10, wherein the controller (processor 110 directs operation of medicament delivery device 102; control application 116 may be a single program, multiple programs, modules, libraries, or the like; para [0042]) is further configured to use alternative control parameter corresponding to the at least one drug name in the drug database (storage 114 may hold histories 111 for a user, such as a history of basal deliveries, a history of bolus deliveries, and/or other histories, such as a meal event history, exercise event history, glucose level history and the like, [0043]).
Lee does not, however, disclose a configuration to output an alarm message when detecting that the frequency of use of the alternative control parameter is lower than a set frequency threshold.
Desborough teaches a configuration to output an alarm message when detecting that the frequency of use of the alternative control parameter is lower than a set frequency threshold (Desborough teaches that bolus dosages can be more frequently dispensed based on calculations and system monitoring of usage and can provide an alert to the user (via the user interface 220 or via the mobile computing device 60) so that the user can manually initiate the administration of a selected bolus dosage of insulin to correct for the rapid increase in blood glucose level; para [0178]).
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 medicament delivery device of Lee to output an alarm message when detecting that the frequency of use of the alternative (updated) control parameter corresponding to the at least one drug name in the drug database is lower than a set frequency threshold, as taught by Desborough, in order to alert the user or clinician when the updated parameter is not being effectively utilized and to prompt corrective action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571)272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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