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 Objections
Claims 1-7 are objected to because of the following informalities:
The preambles of claims 1-7 lack an article and should recite “A computerized system”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-15 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 1 recites the limitations “the BT corresponding to a minimal possible drug dosage…the IT corresponding to a minimal possible drug dosage” in lines 15-18. It is unclear how these thresholds differ as they are described in exactly the same manner. For the sake of examination, the limitations will be interpreted as reciting “the BT corresponding to a minimal possible bolus drug dosage…the IT corresponding to a minimal possible insulin dosage”.
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)(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 1-4, 8-11, 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mazlish (US 2025/0099680).
Mazlish discloses a computerized system for communicating treatment information to a user, wherein the computerized system comprises: a memory storing data comprising, at least, time-based user metabolite data (Para 0064, 0105); a processor comprising: a dose determination module adapted to determine a possible drug dosage based on said data (Para 0011, 0045); a disturbance module adapted to determine whether said data or the possible drug dosage triggers at least a disturbance threshold from a plurality of disturbance thresholds (Para 0021-0022); a notification module adapted to, when the disturbance module determines that the at least one disturbance threshold is triggered or when at least a disturbance bypass is triggered, issue a user notification, the user notification being issued to the user and comprising the possible drug dosage (Para 0082, 0092); wherein the plurality of disturbance thresholds comprises: a bolus threshold hereinafter referred as BT, the BT corresponding to a minimal possible bolus drug dosage (“bolus threshold”, Para 0041, 0058); a drug threshold hereinafter referred as IT, the IT corresponding to a minimal possible insulin dosage (“personalized delivery actions relative to a threshold” Para 0009, 0047-0048); and a time threshold hereinafter referred as TT, the TT corresponding to a minimal amount of time elapsed since a previous user notification issued to a user or a previous bolus administered to the user (“duration of time without insulin”, Para 0022).
Regarding Claim 2, Mazlish discloses the notification module is adapted to, when the disturbance module determines that at least the BT and the TT are triggered or when at least one disturbance bypass is triggered, issue a user notification (Para 0082, 0092).
Regarding Claim 3, Mazlish discloses the notification module is adapted to, when the disturbance module determines that at least the BT, the IT and the TT are triggered or when at least one disturbance bypass is triggered, issue a user notification (Para 0082, 0092).
Regarding Claim 4, Mazlish discloses the IT depends on a minimum glycemia to correct and a compensation factor (Para 0009, Para 0047; “ threshold amount may be a dynamic amount and the determination of whether an alert should be triggered may be related to an estimated blood glucose level, an amount of insulin on board (IOB) of the PWD, an insulin sensitivity factor (ISF) of the PWD, and/or the total daily basal amount of insulin received by the PWD, or any combinations thereof” ).
Regarding Claim 8, Mazlish discloses a method for communicating treatment information to a user, wherein the method is implemented by a computerized system and comprises: data reception , the step of data reception consisting of receiving data comprising at least time-based user metabolite data (Para 0065); drug dosage determination, the step of drug dosage determination consisting of determining a possible drug dosage based on said data (Para 0011, 0045); trigger determination, the step of trigger determination consisting of determining whether said data or the possible drug dosage triggers at least a disturbance threshold from a plurality of disturbance thresholds (Para 0021-0022); and issuing notification, the step of issuing notification consisting of issuing a user notification to a user when it is determined, during the step of trigger determination, that at least one threshold from the plurality of disturbance thresholds is triggered or when at least a disturbance bypass is triggered, the user notification comprising the possible drug dosage (Para 0082, 0092); wherein the plurality of disturbance thresholds comprises: a bolus threshold hereinafter referred as BT, the BT corresponding to a minimal bolus dose (“bolus threshold”, Para 0041, 0058); a drug threshold hereinafter referred as IT, the IT corresponding to a minimal dose of insulin (“personalized delivery actions relative to a threshold” Para 0009, 0047-0048); and a time threshold hereinafter referred as TT, the TT corresponding to a minimal amount of time elapsed since a previous user notification issued to a user or a previous bolus administered to the user (“duration of time without insulin”, Para 0022).
Regarding Claim 9, Mazlish discloses the step of issuing notification consists of issuing a user notification to a user when it is determined, during the step of trigger determination, that at least the BT and the TT are triggered or when at least one disturbance bypass is triggered (Para 0082, 0092).
Regarding Claim 10, Mazlish discloses the step of issuing notification consists of issuing a user notification to a user when it is determined, during the step of trigger determination, that at least the BT, the IT and the TT are triggered or when at least one disturbance bypass is triggered (Para 0082, 0092).
Regarding Claim 11, Mazlish discloses the IT depends on a minimum glycemia to correct and a compensation factor (Para 0009, Para 0047; “ threshold amount may be a dynamic amount and the determination of whether an alert should be triggered may be related to an estimated blood glucose level, an amount of insulin on board (IOB) of the PWD, an insulin sensitivity factor (ISF) of the PWD, and/or the total daily basal amount of insulin received by the PWD, or any combinations thereof” ).
Regarding Claim 15, Mazlish discloses the program is executed by a computer, cause the computer to carry out the steps of the method of claim 8 (Para 0045; Para 0105).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-6, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mazlish (US 2025/0099680) in view of Burke (US 2016/0303313).
Regarding Claim 5, Mazlish discloses a BT (Para 0041), however, is silent regarding the BT decreases depending on the amount of time elapsed since a previous user notification has been issued to a user or a previous bolus has been administered to the user.
Burke teaches a computerized system having a bolus threshold wherein there is a minimum wait time between successive requests for bolus doses (Para 0054, 0098; thus, the BT is 0 before the wait time has elapsed and then is based on other metrics (total volume, etc.) after the wait time. So, the smaller the elapsed time, the smaller the BT).
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 bolus threshold to incorporate a wait time wherein the threshold zero and no bolus is allowed until the wait time has elapsed as taught by Burke in order to ensure that the patient isn’t given too much of the drug at one time or over any other given period of time (Para 0098).
Regarding Claim 6, the modified invention of Mazlish and Burke discloses the BT has a minimum insulin value after a certain amount of time elapsed since a previous user notification has been issued to a user or a previous bolus has been administered to the user (Para 0098 -Burke; the minimum insulin value can be 0 the certain amount of time elapsed is within the wait period).
Regarding Claim 12, Mazlish discloses a BT (Para 0041), however, is silent regarding the BT decreases depending on the amount of time elapsed since a previous user notification has been issued to a user or a previous bolus has been administered to the user.
Burke teaches a computerized system having a bolus threshold wherein there is a minimum wait time between successive requests for bolus doses (Para 0054, 0098; thus, the BT is 0 before the wait time has elapsed and then is based on other metrics (total volume, etc) after the wait time. So, the smaller the elapsed time, the smaller the BT).
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 bolus threshold to incorporate a wait time wherein the threshold zero and no bolus is allowed until the wait time has elapsed as taught by Burke in order to ensure that the patient isn’t given too much of the drug at one time or over any other given period of time (Para 0098).
Regarding Claim 13, the modified invention of Mazlish and Burke discloses the BT has a minimum insulin value after a certain amount of time elapsed since a previous user notification has been issued to a user or a previous bolus has been administered to the user (Para 0098 -Burke; the minimum insulin value can be 0 the certain amount of time elapsed is within the wait period).
Claims 7, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mazlish (US 2025/0099680) in view of Palerm (US 2016/0175520).
Regarding Claim 7, Mazlish discloses all of the elements of the invention as discussed above, however, is silent regarding a disturbance bypass is an emergency bypass, said emergency bypass being triggered wherein a risk for the user is identified from the data.
Palerm teaches a computerized system having a disturbance bypass is an emergency bypass, said emergency bypass being triggered wherein a risk for the user is identified from the data (“override”, Para 0032).
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 computer system to have a disturbance bypass triggered wherein a risk for the user is identified from the data as taught by Palerm in order to override an alert when a correction bolus is having the anticipated effect on the user’s glucose to prevent a hyperglycemic event (Para 0032).
Regarding Claim 14, Mazlish discloses all of the elements of the invention as discussed above, however, is silent regarding a disturbance bypass is an emergency bypass, said emergency bypass being triggered wherein a risk for the user is identified from the data.
Palerm teaches a computerized system having a disturbance bypass is an emergency bypass, said emergency bypass being triggered wherein a risk for the user is identified from the data (“override”, Para 0032).
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 computer system to have a disturbance bypass triggered wherein a risk for the user is identified from the data as taught by Palerm in order to override an alert when a correction bolus is having the anticipated effect on the user’s glucose to prevent a hyperglycemic event (Para 0032).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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