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 63/704,328, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 2A Prong One
Claims 1, 9, and 20 (claim 1 representative) recite generating a physiological model for estimating glucose values of the patient based on historical data, the historical data comprising glucose value history and insulin dosage history for a time window during which the patient consumed a plurality of meals; estimating, using the physiological model and the historical data, an impact of the plurality of meals on the glucose values of the patient; receiving a first meal size indication of a first meal for consumption by the patient; and outputting a first meal bolus insulin dose recommendation based on the impact of the plurality of meals on the glucose values of the patient and the first meal size indication.
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations in the mind of a user which constitute Mental Processes, but for the recitation of generic computer components. The Mental Processes include subcategories of observation and mental evaluation. For example, these recitations encompass mentally modeling estimated glucose values of a patient based on observed historical glucose values, insulin dosages, and meal consumption during a time window. The claims further encompass observing a patient meal size and outputting by mentally deriving an insulin dose based on the meals and meal size. These steps could be carried out by a doctor observing patient data to derive an insulin dose. Therefore, these claims recite limitations that fall into the Mental Processes grouping of abstract ideas.
Claims 2-8 and 10-19 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claims 2, 4-8, 10, and 12-19 further expand on the meal times, meal impacts, and meal insulin doses. Claims 3 and 11 incorporates an insulin sensitivity into the mental model used to estimate the dosing. As explained above, these steps encompass Mental Processes.
Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas along with insignificant, extra-solution data transmitting activity.
Claims 9-20, directly or indirectly, recite the following additional elements at a high level of generality and merely utilized as tools to implement the abstract idea:
Claims 9-19:
one or more processors; and one or more processor-readable media storing instructions which, when executed by the one or more processors, cause performance.
Claim 20:
One or more non-transitory processor readable media storing instructions which, when executed by one or more processors, cause performance.
The written description discloses that the recited computer components encompass generic components including “where the computing device 130 is a consumer device such as a smartphone, tablet computer, laptop computer, or the like, the user interfaces would include a display device, a physical and/or virtual keyboard, and/or audio speakers provided by such consumer devices, among other things” (see paragraph 0035). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Claims 8 and 19, directly or indirectly, recite the following additional elements at a high level of generality, involving no more that extra-solution data transmitting activity:
Claims 8 and 19:
sending a message…to a user device, or providing a message…via a user interface.
These additional elements are recited at a high degree of generality and are merely involved in insignificant extra solution data transmission of a message. As set forth in MPEP 2106.05(g) insignificant, extra-solution activity, such as insignificant acquisition and data transmission, is an example of when an abstract idea has not been integrated into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”).
Insignificant, extra solution, data transmitting activity (e.g. sending a message to a device or interface) has been found to not amount to significantly more than an abstract idea (see MPEP 2106.05(g) and Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016)).
Additionally, the aforementioned additional elements, considered in combination, do not provide an improvement to a technical field or provide a technical improvement to a technical problem. These additional elements merely carry out the abstract idea through data processing and data communication. Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
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.
Claim(s) 1-3, 5-11, and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Fischell, US Patent No. 9,171,343.
As per claim 1, Fischell teaches a method of providing personalized insulin dosage recommendations for a patient, the method comprising: generating a physiological model for estimating glucose values of the patient based on historical data, the historical data comprising glucose value history and insulin dosage history for a time window during which the patient consumed a plurality of meals (see column 2, line 66 – column 3, line 19; parameters for estimating glucose of the patient include history of blood glucose results corresponding units of insulin and corresponding consuming of meals in terms of grams of carbohydrates ingested); estimating, using the physiological model and the historical data, an impact of the plurality of meals on the glucose values of the patient (see column 2, line 66 – column 3, line 19; the history of carbohydrates ingested, administered insulin, and glucose readings provide an impact of the meals on the glucose values of the patient); receiving a first meal size indication of a first meal for consumption by the patient (see column 2, line 66 – column 3, line 19; system uses the next time a certain number of grams of carbohydrates are to be eaten for generating a recommendation); and outputting a first meal bolus insulin dose recommendation based on the impact of the plurality of meals on the glucose values of the patient and the first meal size indication (see column 2, line 66 – column 3, line 19; generates recommended insulin to be injected dependent upon prior results experienced by the specific subject).
As per claim 2, Fischell teaches the method of claim 1 as described above. Fischell further teaches identifying a plurality of meal times based on the glucose value history and the insulin dosage history, wherein each meal time of the plurality of meal times corresponds to a time, during the time window, at which the patient consumed a respective meal of the plurality of meals (see column 4, lines 3-15; identifies previous meal times, such as breakfast meal, corresponding glucose values and insulin dosage).
As per claim 3, Fischell teaches the method of claim 1 as described above. Fischell further teaches determining an insulin sensitivity of the patient based on the glucose value history and insulin dosage history, wherein generating the physiological model is further based on the insulin sensitivity of the patient (see column 16, line 50 – column 7, line 2; shows insulin sensitivity within a function of glucose and insulin dosage determined above in the context of historical values).
As per claim 5, Fischell teaches the method of claim 1 as described above. Fischell further teaches the first meal size indication is indicative of an estimated number of carbohydrates in the first meal (see column 2, line 66 – column 3, line 19; estimated ingestion of number of grams of carbohydrates).
As per claim 6, Fischell teaches the method of claim 1 as described above. Fischell further teaches subsequent to outputting the first meal bolus insulin dose recommendation: receiving an indication of a time of consumption of the first meal by the patient (see column 4, lines 3-15; identifies previous meal times, such as breakfast meal); obtaining post-meal data comprising one or more additional glucose values of the patient, measured subsequent to consumption of the first meal by the patient (see column 22, lines 13-14; post-meal glucose reading taken subsequent to lunch); calculating a correction bolus insulin dose based on the post-meal data (see column 9, lines 35-38; calculates the corrected dose of insulin depending on historic data); and outputting a recommendation comprising the correction bolus insulin dose based on a determination that the correction bolus insulin dose exceeds a predetermined threshold (see column 21, line 67 – column 22, line 5; correction dose based on glucose threshold).
As per claim 7, Fischell teaches the method of claim 1 as described above. Fischell further teaches subsequent to outputting the first meal bolus insulin dose recommendation: obtaining post-meal data comprising: a time of consumption of the first meal by the patient, one or more additional glucose values of the patient measured subsequent to consumption of the first meal by the patient, and an indication of a meal bolus insulin dose administered to the patient in conjunction with the consumption of the first meal by the patient (see column 3, lines 9-13; at a subsequent time that the -user takes the same or similar glucose reading and number of grams of carbohydrates to be eaten; subsequent time data being in relation to same or similar first time of consumption); receiving a second meal size indication of a second meal for consumption by the patient (see column 3, lines 9-13; at a subsequent time that the user takes the same or similar glucose reading and number of grams of carbohydrates to be eaten); and outputting a second meal bolus insulin dose recommendation based on the post- meal data, the impact of the plurality of meals on the glucose values of the patient, and the second meal size indication (see column 3, lines 12-14; the system knows the previous insulin dose -recommendations is too high and makes a second recommendation based on the known impact of the meals on the glucose of the patient).
As per claim 8, Fischell teaches the method of claim 1 as described above. Fischell further teaches outputting the first meal bolus insulin dose recommendation comprises at least one of: sending a message indicative of the first meal bolus insulin dose recommendation to a user device, or providing a message indicative of the first meal bolus insulin dose recommendation via a user interface (see column 10, lines 19-31; sends message recommended insulin to patient’s smart phone).
Claims 9-11, 14, 17, and 19 recite substantially similar system limitations to method claims 1-3 and 6-8 and, as such, are rejected for similar reasons as given above.
As per claim 15, Fischell teaches the system of claim 14 as described above. Fischell further teaches outputting the recommendation is further based on a determination that: a threshold duration of time has passed since a meal bolus insulin dose was administered to the patient in conjunction with the consumption of the first meal by the patient (see column 21, line 43 – column 22, line 5; throughout the recommendation process, a variety of time periods are tracked to determine whether certain periods have elapsed including from meal intake and insulin dosing); and the correction bolus insulin dose exceeds a higher-alert insulin threshold (see column 21, line 64 – column 22, line 5; correction dose calculated based on insulin time period and dose thresholds).
As per claim 16, Fischell teaches the system of claim 14 as described above. Fischell further teaches outputting the recommendation is further based on a determination that: a threshold duration of time has passed since the time of the consumption of the first meal by the patient (see column 21, line 43 – column 22, line 5; throughout the recommendation process, a variety of time periods are tracked to determine whether certain periods have elapsed including from meal intake and insulin dosing), and the correction bolus insulin dose does not exceed a higher-alert insulin threshold (see column 21, line 64 – column 22, line 5; correction dose calculated based on insulin time period and dose thresholds).
As per claim 18, As per claim 16, Fischell teaches the system of claim 17 as described above. Fischell further teaches the post-meal data further comprises a remaining meal tracked based on model parameters used for determining the first meal bolus insulin dose recommendation (see column 19, lines 33-40; meal data is tracked based on subject being on a fixed meal plan).
Claim 20 recites substantially similar computer media limitations to method claim 1 and, as such, is rejected for similar reasons as given above.
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.
Claim(s) 4 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell, US Patent No. 9,171,343 in view of Mazlish, US Patent Application Publication No. 2014/0128705.
As per claim 4, Fischell teaches the method of claim 1 as described above. Fischell does not explicitly teach estimating the impact of the plurality of meals on the glucose values of the patient comprises generating a plurality of meal impact curves using the historical data, wherein each meal impact curve of the plurality of meal impact curves is indicative of estimated glucose values of the patient for a respective meal of the plurality of meals, over a period of time following the respective meal. Mazlish teaches estimating the impact of a plurality of meals on the glucose values of a patient comprises generating a plurality of meal impact curves using historical data, wherein each meal impact curve of the plurality of meal impact curves is indicative of estimated glucose values of the patient for a respective meal of the plurality of meals, over a period of time following the respective meal (see paragraph 0074; generates a plurality of curves representing effects of carbohydrates on glucose as a function of amount of time elapsed). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate the curves of Mazlish for the insulin dose recommendations of Fischell with the motivation of helping user in balance proper insulin dosing specific to the patient (see paragraph 0004 of Mazlish).
Claim 12 recites substantially similar system limitations to method claim 4 and, as such, is rejected for similar reasons as given above.
As per claim 13, Fischell and Mazlish teaches the system of claim 12 as described above. Fischell further teaches the one or more processor-readable media further store instructions which, when executed by the one or more processors, cause performance of: extracting a set of predetermined meal size indications representative of a plurality of different meal types, wherein the first meal size indication comprises a predetermined meal size indication from the set of predetermined meal size indications (see column 10, lines 19-31; sets of meal size indications representing different meals). As noted above, Fischell does not explicitly teach the use of the meal impact curves. Mazlish teaches extracting data from meal impact curves (see paragraph 0074; generates a plurality of curves representing effects of carbohydrates on glucose as a function of amount of time elapsed). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to incorporate the curves of Mazlish for the insulin dose recommendations of Fischell for the reasons given above with respect to claim 4.
D
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rimon et al., Advancements in Insulin Pumps: A Comprehensive Exploration of Insulin Pump Systems, Technologies, and Future Directions, discloses determining insulin dose amount based, in part, on meal ingestion.
Constantin, International Publication No. WO 2021/113859, discloses recommending insulin dosages based on glucose values, insulin administration data, meal data, and insulin delivery parameters.
Jiang, US Patent Application Publication No. 2020/0098465, discloses generating optimal insulin recommendations.
Hayter, US Patent Application Publication No. 2010/0298685, discloses monitoring glucose levels after meals and monitoring meal data.
Nimri, US Patent Application Publication No. 2021/0193285, discloses providing recommendation data regarding the setting of an insulin pump including insulin dosing parameters, carbohydrate ratio, and correction factor.
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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C. Luke Gilligan
Primary Examiner
Art Unit 3683
/CHRISTOPHER L GILLIGAN/ Primary Examiner, Art Unit 3683
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