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 4, 5 and 8 are objected to because of the following informalities:
Regarding claim 4, lines 1-2, the recitation “a crashing glucose level condition” appears to be amended to recite “the crashing glucose level condition” in order to refer to “a crashing glucose level condition” recited in claim 1, line 9.
Regarding claim 5, lines 1-2, the recitation “a crashing glucose level condition” appears to be amended to recite “the crashing glucose level condition” in order to refer to “a crashing glucose level condition” recited in claim 1, line 9.
Regarding claim 5, line 2, the recitation “a threshold” appears to be amended to recite “the threshold” in order to refer to “a threshold” recited in claim 2, last line.
Regarding claim 8, last line, the recitation “cannula” appears to be amended to recite “the cannula” in order to refer to “a cannula” recited in claim 8, line 1.
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 7, 10-17 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.
Regarding claim 7, line 2, the recitation “an amount of insulin” renders the claim indefinite because the claim is unclear regarding whether “insulin” refers to “medicament” recited in claim 1 or additional. For examination purposes, examiner construes “insulin” being referring to “medicament” recited in claim 1. Claim 7 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if the claim is amended to specify that medicament includes insulin.
Regarding claim 10, line 13, the recitation “the glucose prediction model” renders the claim indefinite because the claim is unclear if “the glucose prediction model” refers to “a glucose prediction model” recited in claim 10, lines 8-9 or “glucose prediction model” recited in claim 10, line 12. For examination purposes, examiner construes that “the glucose prediction model” refers to a new glucose prediction model and “glucose prediction model” recited in claim 10, line 12 refers to “a glucose prediction model” recited in claim 10, lines 8-9.
Claims 11-17 being dependent on claim 10 are also rejected.
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.
Claims 1, 7-9, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Connor et al. (US 2021/0313037 A1).
Regarding claim 1, O’Connor teaches a medicament delivery system (figure 5) for delivering medicament to a user, comprising:
a non-transitory computer-readable storage medium 513 (paragraph 0013, lines 9-13) storing computer programming instructions;
a processor 516 (paragraph 0065, figure 5 shows element 518 as processor) configured for executing the computer programming instructions to cause the processor to:
predict a first future glucose level 331 (paragraph 0044) of the user using a first model that predicts the future glucose level based on glucose level history of the user and medicament deliveries to the user;
detect (paragraph 0045) a crashing glucose level condition of the user;
in response to the detecting of the crashing glucose level condition, switching to a second model (paragraph 0045) to predict a next future glucose level of the user, the second model having different parameter values than the first model such that the second model predicts lower future glucose levels for the user than the first model when glucose levels of the user are decreasing.
Regarding claim 7, O’Connor teaches wherein in response to detecting of the crashing glucose level condition, the processor decreases an upper bound of an amount of insulin that may be delivered by the medicament delivery device to the user over a time period (paragraph 0037, lines 16-21, the adjustment will involve reducing the delivery of the insulin otherwise glucose level would drop to significant level).
Regarding claim 8, O’Connor teaches wherein the computer programming instructions when executed further cause the processor to determine a basal insulin delivery dosage for the user based on the predicted next future glucose level of the user that was predicted using the second model (paragraphs 0048, 0049).
Regarding claim 9, O’Connor teaches further comprising a cannula and/or needle (paragraph 0059) for delivering the medicament to the user and wherein the computer programming instructions when executed by the processor further cause the processor to initiate delivery of the basal insulin delivery dose to the user via the needle and/or cannula.
Regarding claim 18, O’Connor teaches a medicament delivery system (figure 5) for delivering medicament to a user, comprising:
a non-transitory computer-readable storage medium 513 (paragraph 0013, lines 9-13) storing computer programming instructions;
a processor 516 (paragraph 0065, figure 5 shows element 518 as processor) configured for executing the computer programming instructions to cause the processor to:
use a current model 331 to predict a response in analyte levels of the user to delivering a dose of medicament;
responsive to detecting a condition, swap the current model for an additional model 343 or updating the current model based on new analyte level data; and
use the additional model 343 or the updated current model to modify the medicament dose delivery 373 (paragraph 0050, lines 3-9) for the user.
Regarding claim 19, O’Connor teaches wherein the detected condition is rapidly changing analyte level data (paragraph 0042, lines 13-28).
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.
Claims 2, 3, 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connor et al. (US 2021/0313037 A1) in view of Steil et al. (US 2003/0130616 A1).
Regarding claim 2, O’Connor discloses the claimed invention substantially as claimed, as set forth above in claim 1. O’Connor is silent regarding wherein the processor detects the crashing glucose level condition by determining differences between successive pairs of glucose level readings of a sequence of most recent glucose level readings of the user that extends from an oldest glucose level reading in the sequence to a most recent glucose level reading in the sequence and comparing each of the differences to a threshold.
However, Steil teaches a design of a closed loop system (figure 1) for controlling insulin infusion wherein the processor detects the crashing glucose level condition by determining differences between successive pairs of glucose level readings (paragraph 0243, lines 17-20, paragraph 0125, lines 7-8, paragraph 0096, lines 22-26) of a sequence of most recent glucose level readings of the user that extends from an oldest glucose level reading in the sequence to a most recent glucose level reading in the sequence and comparing each of the differences to a threshold for the purpose of processing the data to find out the rate of change in the glucose level (paragraph 0243, lines 17-20).
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 processor of O’Connor to incorporate wherein the processor detects the crashing glucose level condition by determining differences between successive pairs of glucose level readings of a sequence of most recent glucose level readings of the user that extends from an oldest glucose level reading in the sequence to a most recent glucose level reading in the sequence and comparing each of the differences to a threshold as taught by Steil for the purpose of processing the data to find out the rate of change in the glucose level (paragraph 0243, lines 17-20).
Regarding claim 3, O’Connor discloses the claimed invention substantially as claimed, as set forth above in claim 1. O’Connor is silent regarding wherein the processor detects the crashing glucose level condition by comparing the differences to each other to determine if the differences between the successive pairs of glucose level readings of the user become more negative as the differences range from an oldest glucose level reading pair to a most recent glucose level reading pair.
However, Steil teaches wherein the processor detects the crashing glucose level condition by comparing the differences to each other to determine if the differences between the successive pairs of glucose level readings of the user become more negative (paragraph 0243, lines 17-20, paragraph 0125, lines 7-8, paragraph 0096, lines 22-26, while Steil does not explicitly mention about negative value but taking difference between two consecutive readings will generate negative value) as the differences range from an oldest glucose level reading pair to a most recent glucose level reading pair for the purpose of processing the data to find out the rate of change in the glucose level (paragraph 0243, lines 17-20).
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 processor of O’Connor to incorporate wherein the processor detects the crashing glucose level condition by comparing the differences to each other to determine if the differences between the successive pairs of glucose level readings of the user become more negative as the differences range from an oldest glucose level reading pair to a most recent glucose level reading pair as taught by Steil for the purpose of processing the data to find out the rate of change in the glucose level (paragraph 0243, lines 17-20).
Regarding claim 6, O’Connor discloses the claimed invention substantially as claimed, as set forth above in claim 1. O’Connor is silent regarding wherein the processor detects crashing glucose level condition by looking for glucose level readings of the user dropping at an acceleration rate.
However, Steil teaches wherein the processor detects crashing glucose level condition by looking for glucose level readings of the user dropping at an acceleration rate (paragraph 0243, lines 17-20, paragraph 0125, lines 7-8, paragraph 0096, lines 22-26) for the purpose of processing the data to find out the rate of change in the glucose level (paragraph 0243, lines 17-20).
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 processor to incorporate wherein the processor detects crashing glucose level condition by looking for glucose level readings of the user dropping at an acceleration rate as taught by Steil for the purpose of processing the data to find out the rate of change in the glucose level (paragraph 0243, lines 17-20).
Regarding claim 20, O’Connor discloses the claimed invention substantially as claimed, as set forth above in claim 18. O’Connor further discloses wherein the modification is adjusting delivery of the medicament 373 (figure 3) but is silent regarding wherein the modification is to halt delivery of the medicament.
However, Steil teaches wherein the modification is to halt delivery of the medicament (paragraphs 0126, 0127) for the purpose of controlling the delivery of the medicament based on patient’s glucose level (paragraph 0002) thereby regulating patient’s glucose level (paragraph 0102).
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 modification of O’Connor to incorporate wherein the modification is to halt delivery of the medicament as taught by Steil for the purpose of controlling the delivery of the medicament based on patient’s glucose level (paragraph 0002) thereby regulating patient’s glucose level (paragraph 0102).
Claims 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Doron (US 2020/0015738 A1) in view of O’Connor et al. (US 2021/0313037 A1).
Regarding claim 10, Doron discloses a medicament delivery system (figure 1) for delivering medicament to a user, comprising:
a processor 105 configured for executing the computer programming instructions to cause the processor to:
access a history of medicament delivery doses and glucose level values of the user (paragraph 0082);
based on the history, determine an improved fit of parameters for a glucose prediction model (paragraph 0082, finding the best parameter that minimizes an indicator “m”) from the history relative to current parameters of the glucose prediction model, wherein the glucose prediction model determines predicted future glucose level values for the user from past glucose level values and past medicament delivery doses in the history, such that glucose prediction model using the improved fit parameters more accurately predicts future glucose level values than the glucose prediction model using the current parameters to predict future glucose level values when compared to predicting glucose level values in the history of glucose level values of the user;
adapting the parameters (paragraph 0082, “update of the model”) based on the improved fit of parameters to produce adapted parameters; and
use the glucose prediction model (paragraph 0082) with the adapted parameters to predict at least one future glucose level value of the user.
Doron does not explicitly recite a non-transitory computer-readable storage medium storing computer programming instructions however, one can construe that Doron does disclose the use of a non-transitory computer-readable storage medium storing computer programming instructions in order to perform the method that Doron discloses.
Furthermore, O’Connor teaches a non-transitory computer-readable storage medium 513 (paragraph 0013, lines 9-13) storing computer programming instructions for the purpose of using a well-known electronic component to store the computer programming instructions (paragraph 0013, lines 9-13).
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 medicament delivery system of Doron to incorporate a non-transitory computer-readable storage medium storing computer programming instructions as taught by O’Connor for the purpose of using a well-known electronic component to store the computer programming instructions (paragraph 0013, lines 9-13).
Regarding claim 11, Doron discloses in determining the improved fit of parameters for glucose prediction model (paragraph 0082), the glucose prediction model determines a best fit of parameters for the glucose prediction model.
Regarding claim 12, Doron discloses wherein the improved fit is the best fit of parameters for the glucose prediction model (paragraph 0082).
Regarding claim 13, Doron discloses wherein the processor uses a genetic algorithm (paragraph 0082, parameters used from past observation period based on the physiological model) to determine the improved fit of the parameters.
Regarding claim 14, Doron discloses wherein the medicament delivery device has operational cycles, receives a glucose level reading each operational cycle, and delivers a basal insulin dose to the user each operational cycle, and wherein the processor in determining the improved for of parameters examines over multiple operational cycles of the medicament delivery device (paragraph 0082).
Regarding claim 15, Doron discloses wherein (paragraph 0095) a maximum deviation of a parameter relative to a population average for parameter candidates is established and at least one of the parameters in the improved fit of parameters is subject to the maximum deviation.
Regarding claim 16, Doron discloses wherein parameters in the improved fit of parameters must conform with a stability constraint (paragraph 0108, “smaller than predetermined thresholds”).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Doron (US 2020/0015738 A1) in view of O’Connor et al. (US 2021/0313037 A1) and further in view of Steil et al. (US 2003/0130616 A1).
Regarding claim 17, Doron/O’Connor (hereinafter referred as “modified Doron”) discloses the claimed invention substantially as claimed, as set forth above in claim 10. Modified Doron is silent regarding wherein glucose level values in the history of glucose level values that are affected by disturbances are removed from consideration in determining the improved fit of parameters.
However, Steil teaches a closed loop system for controlling insulin infusion wherein glucose level values in the history of glucose values that are affected by disturbances are removed from consideration (paragraph 0243) for the purpose of removing anomalous data points (paragraph 0243) thereby ensuring a correct calculation is made with minimal effect from wrong data points.
Therefore, it would have been prima facie obvious to modify the processing of glucose level values in determining the improved fit of parameters of modified Doron to incorporate wherein glucose level values in the history of glucose level values that are affected by disturbances are removed from consideration as taught by Steil for the purpose of removing anomalous data points (paragraph 0243) thereby ensuring a correct calculation is made with minimal effect from wrong data points.
Allowable Subject Matter
Claims 4 and 5 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.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, O’Connor et al. (US 2021/0313037 A1) in view of Steil et al. (US 2003/0130616 A1), is silent regarding wherein the processor detects a crashing glucose level condition of the user when each of the differences is more negative than the threshold, each of the differences is negative, and the differences between the successive pairs of glucose level readings of the user become more negative as the differences range from the oldest glucose level reading pair to the most recent glucose level reading pair in combination with other claimed limitations of claim 4.
Claim 5 being dependent on claim 4 is also indicated allowable.
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