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 .
Response to Amendments
The Amendment filed 05/21/2026 has been entered.
Claims 1-21 remain pending in the application.
Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 2/24/2026.
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 1-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim Interpretation
Under the broadest reasonable interpretation, the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See M.P.E.P. § 2111. Claim 1 recites a method/process. While the Background indicates that automated drug delivery (ADD) systems are well known, including, for example, wearable drug delivery devices, and the Detailed Description describes such devices, the broadest reasonable interpretation of the claimed method is not restricted to the performance of any of the claimed manipulative steps on or using such a device. Similarly, Claim 17 recites an automated drug delivery system in its preamble; however, the body of the claim does not further structurally limit that device in any way other than the steps its processor performs according to “software.” Thus, the broadest reasonable interpretation of the claimed system is a device which is not restricted to the performance of any of the claimed functions on or using any particular device.
Step 1
Claim 1 et sqq. are directed to processes, and Claim 17 et sqq. are directed to machines; therefore, all of the currently pending claims are directed to one of the statutory classes of invention listed in sec. 101. Claims 1 and 17 recite the same functional steps, and are therefore grouped together for the purposes of this analysis.
Step 2A, prong one
The claims recite mathematical calculations, namely:
calculating an expected BG level based on one or more mathematical models, and is therefore directed to the abstract idea of using a mathematical model to calculate a number (an expected BG level);
calculating “an average deviation,” and is therefore directed to the abstract idea of using a mathematical formula to calculate a number (a deviation);
calculating “an actual deviation;” (same); and
calculating the difference between the two deviations, and comparing the result of that difference to a predetermined number (“threshold”), and is therefore directed to the abstract idea of using a mathematical formula to calculate a number, and identifying the numerical difference between that result and the predetermined number.
Accordingly, all of the claims pass the tests under Step 2A, prong one, i.e., are directed to a judicial exception.
Step 2A, prong two
Claims 1 and 17 only recite, in addition to the identified judicial exception, raising an alarm indicative of a potential occlusion in a fluid path of the system when the calculated difference is greater than a certain number. The raising of an alarm after performing calculations does not integrate the judicial exception into a practical application because it is merely presenting the results of the claims’ mathematical calculations, which is an insignificant extra-solution activity. Furthermore, raising an alarm, based on a calculation, does not relate to the improved function of a computer or any other technical field whatsoever; and, the additional elements do not apply or use the mathematical calculations to affect a particular treatment or prophylaxis for a disease or medical condition, but rather only give a human person a binary indication of the results of the calculations.
Claim 17 further includes a processor and software which performs the same steps as recited in Claim 1. As such, Claim 17 fundamentally differs from Claim 1 only that it amounts to limiting the process to performing the steps on a general-purpose computing device, which does not integrate the claimed judicial exception into a practical application or provide significantly more (see MPEP 2106.05(f)).
Step 2B
In reevaluating the combination of elements presented by each of the independent claims, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The raising of an alarm after performing calculations does not integrate the judicial exception into a practical application because, both individually and in combination, raising an alarm is both a well-understood, routine, and conventional activity in the art of blood glucose monitoring processes and systems, and is insignificant extra-solution activity (see MPEP 2106.05(g))
Conclusion concerning independent Claims 1 and 17
For the foregoing reasons, Claims 1 and 17 are directed to an abstract idea without significantly more, and therefore are not patent-eligible under sec. 101.
Dependent claims
Claims 2, 6, and 9 further limit the type of mathematical model (IOB, CHO) of Claim 1, which does not change the foregoing analysis; accordingly, the subject matters of Claims 2 and 6 are also patent-ineligible.
Claims 3-5, 7, 8, 10-13, and 18-20 further limit the calculations performed by the mathematical models, by: performing additional calculations, conversions, and assumptions in one of the models; using specified data in one of the models; sets a time period for data used in calculation; uses the statistical measure of standard deviation for the time period. None of these claims’ limitations change the foregoing analysis; accordingly, the subject matters of these claims are also patent-ineligible.
Claims 14-16 and 21 further limit the manner in which the alarm is raised, via a user interface, and the physical nature of the alarm, none of which changes the foregoing analysis, because the limitations presented by these claims only further define the way that the extra-solution activity is performed, i.e., notifying a person of the outcome of the mathematical calculation and thus does not add something substantially more to the claims.
Accordingly, none of dependent claims 2-15 and 18-21 are patent-eligible.
Response to Arguments
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive.
In regards to the Applicant’s argument that the “USPTO's 2019 Revised Guidance (84 Fed. Reg. 50, Jan. 7, 2019) identifies several considerations indicative of integration into a practical application, including whether the claim ‘applies or uses a mathematical concept to effect a particular treatment or prophylactic for a disease or medical condition’.” And that the amended claims do precisely that.”
This is not persuasive for the following reasons
As stated by the Applicant, the deviation-baselining method is applied to effect a patient safety response, which is merely an alarm. The Examiner notes MPEP 2106.05(g) states “A competent draftsman could attach some form of post-solution activity to almost any mathematical formula". 437 U.S. at 590; 198 USPQ at 197; Id. (holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was "post-solution activity"). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity). Therefore raising an alarm is both a well-understood, routine, and conventional activity in the art of blood glucose monitoring processes and systems, and is insignificant extra-solution activity.
In regards to the Applicant’s argument that “The Examiner has not made the factual showing required to support a Step 2B finding.”
This is not persuasive for the following reasons.
The conclusion that "raising an alarm" is a well-understood, routine, and conventional activity in blood glucose monitoring by the Examiner and the core deviation-baselining feature of the claims not found in the previously cited references are unrelated in the determination of the Step 2B finding. Using an abstract idea, like a mathematical model for determining average deviation over time to raise an alarm as claimed are not elements that amount to significantly more than the judicial exception.
Conclusion
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 NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/NELSON ALVARADO/
Patent Examiner
Art Unit 3783
10/07/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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