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 .
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 01/12/2024, 07/28/2025, and 03/06/2026, have been considered by the examiner.
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, 2, 4, 6, 9, 12-14, and 16, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wexler et al. (PGPub 2020/0375549).
[Claim 1] Wexler teaches a method for predicting blood glucose levels (paragraph [0014]) comprising:
receiving a first medical data set (figure 4, items 402a or 402b) of a patient covering a time range, the first medical data set comprising glucose data and other medical data of the patient (paragraph [0088]);
extracting a second medical data set (figure 4, items 410 or 420) from the first medical data set (figure 4, items 402a or 402b), wherein the second medical data set (figure 4, items 410 or 420) is a subset of the first medical data set (figure 4, items 402a or 402b) (figure 4; paragraph [0093]) and wherein the extracting comprises at least one of:
b) identifying data values that lie above a predefined maximum threshold data value and removing data associated with the identified data values (paragraphs [0055], [0056], [0060]);
c) identifying data values that lie below a predefined minimum threshold data value and removing data associated with the identified data values (paragraphs [0055], [0056], [0060]);
d) identifying data values that differ from predetermined expected data values by more than a predetermined amount and removing data associated with the identified data values (paragraphs [0055], [0056], [0060]);
e) identifying incomplete data for which data values are missing and removing identified incomplete data (paragraphs [0055], [0056], [0060]);
providing the extracted second medical data set (figure 4, items 410 or 420) as input to a blood glucose level prediction model (figure 4, items 414 or 424) (paragraphs [0056], [0060], [0089], [0092]); and
predicting future blood glucose levels (figure 6c, item 624c) of the patient using the output of the blood glucose level prediction model (figure 4, items 414 or 424) based on the second medical data set (figure 4, items 410 or 420) (figure 4; paragraphs [0014], [0089], [0092], [0117]).
[Claim 2] Wexler teaches the limitations of claim 1, upon which claim 2 depends. In addition, Wexler discloses the other medical data of the patient comprises at least one of the following: amount of carbohydrates from meal intakes, other data on meal intakes, data on insulin injections, other data on medication, and/or other analyte data (paragraph [0042]).
[Claim 4] Wexler teaches the limitations of claim 1, upon which claim 4 depends. Wexler also teaches the method comprises identifying data values that lie above a predefined maximum threshold data value (paragraphs [0055], [0056], [0060]) based on a value for the predefined maximum threshold data value which is derived from statistical analysis of previously recorded medical data sets of the patient (paragraphs [0035], [0047], [0063], [0067], [0068], [0081]).
[Claim 6] Wexler teaches the limitations of claim 1, upon which claim 6 depends. Wexler further discloses providing the extracted second medical data set (figure 4, items 410 or 420) as input to a blood glucose level prediction model (figure 4, items 414 or 424) comprises identifying in the second medical data set (figure 4, items 410 or 420) at least one data segment (data may be discarded and/or associated with specific parameters; paragraphs [0056], [0057]), wherein the at least one data segment is a subset of a plurality of data points of the extracted second medical data set (figure 4, items 410 or 420) that covers at least a minimum time range (figure 4; paragraphs [0056], [0057], [0060], [0089], [0092]).
[Claim 9] Wexler teaches the limitations of claim 1, upon which claim 9 depends. Wexler also discloses providing the extracted second medical data set (figure 4, items 410 or 420) as input to a blood glucose level prediction model (figure 4, items 414 or 424) comprises providing the extracted second medical data set (figure 4, items 410 or 420) as a training data set (paragraphs [0065], [0082]) to a blood glucose level prediction model algorithm (figure 4, item 430) and training the blood glucose level prediction model algorithm (figure 4, item 430) with the extracted second medical data set (figure 4, items 410 or 420) (figure 4; paragraphs [0065], [0071], [0077], [0079], [0081], [0082]).
[Claims 12-14 and 16] Wexler teaches the limitations of claim 1, upon which claims 12-14 and 16 depend. In addition, Wexler teaches the method of claim 1 is performed via a glucose monitoring system (figure 1, item 100), the glucose monitoring system (figure 1, item 100) comprising:
a sensor (figure 1, item 104a) for obtaining glucose data of the patient (paragraph [0032]);
a computing system (figure 1, item 102) comprising a computer memory (computer-readable storage medium) (paragraph [0031]), one or more processors (paragraph [0031]), and a display (paragraph [0032]), wherein the computing system (figure 1, item 102) is one of the following types: a computer server, a personal computer, a smartphone, a tablet, a laptop or other mobile computing system (paragraphs [0032], [0052]); and
wherein the computing system (figure 1, item 102) is configured to receive the first medical data set (figure 4, items 402a or 402b) of the patient and the computer memory (paragraph [0031]) comprises computer-executable instructions (paragraphs [0031], [0053]) which, when executed by the one or more processors (paragraph [0031]), cause the one or more processors (paragraph [0031]) to perform the method according claim 1 for predicting blood glucose levels (figures 1, 4, and 7; paragraphs [0053], [0075], [0125]).
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wexler et al. (PGPub 2020/0375549), in view of Patek et al. (PGPub 2020/0205744) (hereinafter Patek ‘744).
[Claim 7] Wexler teaches the limitations of claim 1, upon which claim 7 depends. Although disclosing identifying data values that differ from predetermined expected data values by more than a predetermined amount (paragraphs [0055], [0056], [0060]); Wexler does not specifically disclose this includes checking whether a recorded bolus insulin amount differs from an expected bolus insulin amount by more than a predetermined amount.
However, Patek ‘744 teaches a system and method (figure 1, item 100) for predicting blood glucose levels (paragraphs [0043], [0049], [0050]), wherein the method comprises checking whether a recorded bolus insulin amount (“historical”) differs from an expected bolus insulin amount (“optimal”) by more than a predetermined amount (figures 2, 3a, and 3b; paragraphs [0053]-[0058], [0093]-[0096]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by Wexler, with the claimed functionality of monitoring bolus insulin, as taught by Patek ‘744, in order to provide increased functionality and control, by allowing for a means by which a user might utilize past trends to optimize future blood glucose levels (Patek ‘744; paragraphs [0107]-[0110]).
[Claim 10] Wexler teaches the limitations of claim 9, upon which claim 10 depends. Wexler does not specifically disclose the blood glucose level prediction model is based on the Kirchsteiger model.
However, Patek ‘744 teaches a system and method (figure 1, item 100) for predicting blood glucose levels (paragraphs [0043], [0049], [0050]), wherein a blood glucose level prediction model is based on the Kirchsteiger model (paragraph [0070]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by Wexler, with the claimed use of the Kirchsteiger model, as taught by Patek ‘744, in order to provide increased functionality and reliability, by allowing for a means by which blood glucose level predictions might be based on a known and validated statistical analysis.
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wexler et al. (PGPub 2020/0375549), in view of Patek et al. (PGPub 2020/0402634) (hereinafter Patek ‘634).
[Claim 11] Wexler teaches the limitations of claim 1, upon which claim 11 depends. Although teaching an obtained prediction of future blood glucose levels is displayed to a patient (figure 6c, item 624c; paragraph [0117]) and, based on the obtained prediction of future blood glucose levels, a recommended dosage of insulin to be administered is displayed to the patient (paragraph [0074]), Wexler does not specifically disclose the recommended dosage of insulin is automatically administered via automatic control of an insulin pump to the patient.
However, Patek ‘634 teaches a system and method (figure 6c, item 660) for predicting blood glucose levels (paragraphs [0003], [0069], [0081]), wherein the method comprises generating a recommended dosage of insulin (figure 6c, item 685), which is automatically administered (“closed loop”) (figure 6c, item 692) via automatic control of an insulin pump (figure 6c, item 690) to a patient (figure 6c, item 665) (figure 6c; paragraphs [0035], [0037], [0155]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the method taught by Wexler, with the claimed functionality of automated dosing, as taught by Patek ‘634, in order to provide increased functionality, safety, and control, by allowing for a well-known means by which dosing calculations might be efficiently implemented, as well as reducing potential dosing errors.
[Claim 15] Wexler teaches the limitations of claim 14, upon which claim 15 depends. Although disclosing the glucose monitoring system is configured to determine a recommended dosage of insulin (paragraph [0074]) to be administered based on an obtained prediction of future blood glucose levels (figure 6c, item 624c; paragraph [0117]), Wexler does not specifically disclose an insulin pump and wherein the glucose monitoring system is further configured to control the insulin pump including controlling the dosage of insulin that is administered by the insulin pump.
However, Patek ‘634 teaches a system and method comprising a glucose monitoring system (figure 6c, item 660) (paragraphs [0003], [0069], [0081]), wherein the system comprises an insulin pump (figure 6c, item 690), and wherein the system is configured to control the insulin pump (figure 6c, item 690) including controlling the dosage of insulin (figure 6c, item 692) that is administered by the insulin pump (figure 6c, item 690) (figure 6c; paragraphs [0035], [0037], [0155]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to modify the system and method taught by Wexler, with use of an insulin pump, as well as the claimed functionality of dosing control, as taught by Patek ‘634, in order to provide increased functionality, safety, and control, by allowing for a well-known means by which dosing calculations might be efficiently implemented, as well as reducing potential dosing errors.
Allowable Subject Matter
Claims 3, 5, and 8, 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 03/19/2026
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