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 .
Priority
Applicant’s claim for the benefit of a prior-filed application, 63/668,620 filed 07/08/2024, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Interpretation
Claims 1-20 recite an abstract idea directed to generating proposed medication doses, predicting analyte values for the doses, applying a cost function to the doses and predicted analyte values, and selecting a set of doses based on the output of the cost function for administering to a user. However, the claims also recite weighting values of the doses based on how close the doses are to a prediction horizon and transmitting a control signal configured to cause an automated medicament delivery device to deliver the medicament in an amount defined by the selected doses. As described at paragraphs 0006-0007 of the specification, typical AMD systems apply equal weighting, leading to sub-optimal dosing. As further described at paragraphs 0209-0223, by weighting closer values higher than more distant ones, the resulting doses are better suited to the patient. The claims combination of limitations carry out this technical improvement to the automated medication delivery device by transmitting a signal to cause the device to deliver the medication in an amount defined by the selected doses. This integrates the abstract idea into a practical 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) 1-2, 4, 7-9, and 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haidar, US Patent Application Publication No. 2020/0197605 in view of Nichols, US Patent Application Publication No. 2023/0034408.
As per claim 1, Haidar teaches a computer-implemented method comprising: accessing a model of analyte-medicament dynamics associated with a user of an automated medicament delivery device (see paragraph 0077 Multi Modal Predictive Controller (MMPC) predicts glucose levels throughout a predictive period); generating two or more sets of proposed medicament doses representing medicament doses to be delivered to the user over a period of time defined by a prediction horizon (see paragraph 0048; determines insulin doses over the future period to a prediction horizon); for each set of the proposed medicament doses, using the model to calculate a set of predicted analyte values corresponding to the proposed medicament doses (see paragraph 0077 Multi Modal Predictive Controller (MMPC) predicts glucose levels throughout a predictive period); applying a cost function to each set of the proposed medicament doses and corresponding set of predicted analyte values, wherein the cost function weighs values that represent doses in the sets to the prediction horizon (see paragraph 0036; MMPC applies predicted glucose values over time as a predicted trajectory and applies an objective function to corresponding insulin trajectory out to a projection horizon; paragraph 0048; insulin doses over a time period may be weighted); selecting one of the two or more sets of proposed medicament doses based on an output of the cost function (see paragraph 0039; determines optimal insulin dose); and transmitting a control signal configured to cause the automated medicament delivery device to deliver the medicament in an amount defined by the selected set of proposed medicament doses (see paragraph 0039; transmits a corresponding insulin request to the insulin pump).
Haidar does not explicitly teach the weight values represent earlier doses in the sets to a greater degree than values that represent later doses in the sets that are closer to the prediction horizon. Nichols teaches applying weighting values that represent earlier events in a set to a greater degree than values that represent later events in the sets that are farther away (see paragraph 0028; CGM readings can be data points for dosing intervals and weighted such that greater weights can be given to readings that are closer in time to current dosing interval). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to weight dosing data points in Haidar in this manner with the motivation of providing more accurate insulin delivery (see paragraph 0027 of Nichols).
As per claim 2, Haidar and Nichols teaches the method of claim 1 as described above. Haidar further teaches the weighing applies weights that are set to predetermined fixed values (see paragraph 0083; weighted insulin doses at each time step).
As per claim 4, Haidar and Nichols teaches the method of claim 1 as described above. Haidar further teaches the weighing applies weights to the prediction horizon (paragraph 0048; insulin doses over a time period may be weighted). Haidar does not explicitly teach applying weights that decrease exponentially (see paragraph 0028; CGM readings can be data points for dosing intervals and weighting that decreases exponentially). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to weight dosing data points in Haidar in this manner for the reasons given above with respect to claim 1.
As per claim 7, Haidar and Nichols teaches the method of claim 1 as described above. Haidar further teaches the weighing applies one or more weights, and further comprising updating the weights at predetermined intervals (see paragraph 0083; weighted insulin doses at each time step equal to the updated period for the insulin dose).
As per claim 8, Haidar and Nichols teaches the method of claim 1 as described above. Haidar further teaches the model is updated based on a prediction accuracy at predetermined intervals (see paragraph 0035; model is updated by selecting the best vector and its model for use in determining the next insulin dose).
As per claim 9, Haidar and Nichols teaches the method of claim 1 as described above. Haidar further teaches the prediction horizon varies based on a prior analyte trajectory (see paragraph 0036; prediction horizon corresponds to predicted glucose trajectory).
Claims 11-15 recite substantially similar computer medium limitations to method claims 1-2, 4, and 8-9 and, as such, are rejected for similar reasons as given above.
Claims 16-20 recite substantially similar system limitations to method claims 1, 4, and 8-9 and, as such, are rejected for similar reasons as given above.
Distinguishing Subject Matter
Claims 3, 5-6, and 10 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 distinguishing subject matter: Claims 3 and 5-6 distinguish over the prior art. The primary reason that claims 3 and 5-6 distinguish over the prior art is the further limitations defining specific aspects of the weightings applied, resulting in the selected medicament doses that are delivered by the medicament delivery device. As described above, the closest prior art (Haidar, Nichols, and Jepson) teaches selecting sets of medicament doses for administering based on differently weighted values. However, the prior art does not describe the specific use of these types of weights being assigned in combination with the operations of claim 1. Additionally, while Jepson describes a decreased prediction horizon, it is not described as decreasing as prior analyte readings exhibit increased variability.
Response to Arguments
In the remarks filed 08/21/2026, Applicant argues (1) Nichols does not teach weighting of proposed medicament doses or predicted analyte values within a cost function over a prediction horizon; (2) there is no motivation to apply the weighting of Nichols to the cost function of Haidar; (3) Jepson does not describe decreasing the prediction horizon in response to increased analyte variability.
In response to argument (1), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Nichols is primarily relied on to show applying weighting values at a greater degree for earlier values than later values. Nichols describes this by applying greater weights to readings that are closer to a current dosing than to those that are later. In combination with Haidar, applying greater weights to closer doses, the cost function would weigh values representing earlier doses to a greater degree than values that represent later doses that are closer to the prediction horizon. Therefore, the examine respectfully maintains that the combination of Haidar and Nichols are encompassed by this recitation.
In response to argument (2), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, one of ordinary skill in the art would have been motivated to adjust weightings in function of Haidar to “provide improved and more accurate insulin delivery” (see paragraph 0027 of Nichols). This is consistent with the predictive modeling of Haidar that has a goal of providing improved adaptability to changes in the environment (see paragraph 0035 of Haidar).
In response to argument (3), the examiner agrees and has withdrawn the 103 rejection of claim 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zheng, US Patent Application Publication No. 2025/0050021, predicting glucose levels of an individual by applying an algorithm that increases weights closer to target glucose values.
Deshpande, International Publication No. WO 2024/059261, discloses a predictive model for insulin dosing that applies a receding horizon minimization cost function.
Jacobs et al., Artificial Intelligence and Machine Learning for Improving Glycemic Control in Diabetes: Best Practices, Pitfalls, and Opportunities, describes AI and ML modeling to determine insulin dosing, applying prediction horizons and weighting.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to C. Luke Gilligan whose telephone number is (571)272-6770. The examiner can normally be reached Monday through Friday 9:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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