DETAILED ACTION
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 1-2, 7-8, 11, 14, 17-18, 20-26, 97-101 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) determining a recommended action for one of the plurality of TOD periods based on the glucose pattern type and the rate of glucose dysregulation. This is a limitation that covers performance in the mind but for the recitation of generic computer components.
This judicial exception is not integrated into a practical application. In particular, while claim 1 recites an input for receiving glucose data of a user and outputting the recommended action to a medication delivery device, they are considered to be an incorporation of insignificant extra-solution activities of data gathering and outputting of results.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As noted above, the use of generic computing devices and incorporation of generic devices into insignificant extra-solution activity is insufficient to amount to significantly more than the abstract idea.
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 1-2, 7-8, 11, 14, 17-18, 20-26, 97-101 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.
As to claim 1, the claim recites “determining a rate of glucose dysregulation for each of the plurality of TOD periods, wherein glucose dysregulation comprises one or more of:
a number of times a glucose signal crosses above or below a threshold glucose value in a time period;
a duration of time a glucose signal is above or below a threshold glucose value in a time period;
an area of a glucose signal over or under a threshold glucose area value in a time period”.
Several aspects of this limitation are unclear. To start, it’s unclear whether each of the recited “time period” is the same time period, or if they could be different time periods. It’s also unclear whether this time period is the same time period as its associated TOD period, or if it’s a different time period that’s just a subset of each TOD period. Furthermore, it’s unclear how a “rate” of glucose dysregulation could be determined from the duration or the area as recited. Since a rate would measure the number of instances occurring over a period of time, and the duration or area could only result in a binary determination of whether it has occurred or not within the defined period of time, it would not appear that the duration or area could be used to give a “rate” of glucose dysregulation. For example, whether the glucose value is in a hyperglycemic range for 10 min or 4 hours over a 4 hour period, the effective “rate” would be 1 in either case. Lastly, it’s unclear how the rate of glucose dysregulation would be determined when multiple of these glucose dysregulations are combined to determine the rate. Claim 97 has similar issues. Where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. See MPEP 2173.06.
As to claim 7, the claim recites the rate of glucose dysregulation comprises a number of days in a time period with a minimum number of instances of glucose dysregulation. It is unclear whether the time period here is the same time period in claim 1, whether it is equal to the entire analysis period, whether it is all of the TOD periods across the analysis period, or some other time period altogether. In addition, as noted above for claim 1, when using the duration or area, it would only result in a binary determination of whether it has occurred or not for each time period, meaning that the only number of instances it can reflect is 1.
As to claim 8, the claim recites determining a frequency of a low glucose alarm within a time period. It is unclear whether the time period here is the same time period in claim 1, whether it is equal to the entire analysis period, whether it is all of the TOD periods across the analysis period, or some other time period altogether. It’s also unclear whether the glucose pattern type and the rate of glucose dysregulation is within the same time period as the time period for determining the frequency of the low glucose alarm. Lastly, as claim 1 notes that the rate of glucose dysregulation could be determined by calculating a duration of time a glucose signal is ABOVE a threshold glucose value and an area of glucose signal OVER a threshold glucose area in a time period, it’s unclear how these calculations could be used in conjunction with the frequency of the LOW glucose alarm, when they would appear to be reflective of a high glucose value.
Response to Arguments
Applicant's arguments filed 3/26/26 have been fully considered but they are not persuasive.
Applicant has argued that the recited claims are patent eligible. In particular, applicant has argued that the amended claims integrates the analysis into a practical application, noting that the recited invention comprises improvements to the technology. Currently, in view of the issues under 35 U.S.C. 112(b), the rejection is being maintained as it is not even clear what the claim is intended to recite, much less recite a practical application to the abstract idea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Davidson et al. (US 2005/0049179) teaches dividing a 24 hour day into multiple time intervals ([0118]) and monitoring average glucose values for each time of day period across multiple days to determine a daily insulin regimen ([0146]).
Anderson et al. (USP #11,182,332) teaches aggregating data and detecting a pattern of glucose levels at similar time of day periods as defined by behavior (e.g. pre-breakfast, post-breakfast, pre-lunch, etc) (Fig. 116 and claim 1) as well as use of the report to determine which time periods require improved control (col. 21 lines 9-28).
Schaible (USP #9,592,002) teaches segregating multiple days’ worth of data by time periods of the day to identify trends correlating to specific time periods (col. 15 line 36-52).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 7/18/26
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