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 .
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.
Claim Objections
Claims 1, 2, 6, 9, 13, 17, and 18 are objected to because of the following informalities:
in Claim 1, lines 5 and 7, “the models” should be “the one or more models;”
in Claim 1, line 4, and Claim 17, lines 7-8, “the expected blood glucose reading” should be “the expected blood glucose level;”
in Claims 2, 9, and 18, “IOB” should be spelled out before the acronym is used;
in Claims 6, 9, and 18, “CHO” should be spelled out before the acronym is used; and
in Claim 13, “were in” should probably be “, wherein”.
While the foregoing issues with the claims do not, in the current view of the Examiner, rise to a level necessitating a rejection under 35 U.S.C. § 112(b), if Applicant asserts that the accused terms and phrases of the claim(s) are entirely unobjectionable and the Examiner disagrees, the objection may be changed to a rejection under sec. 112(b) because Applicant' s and the Examiner' s interpretations of the claims may therefore be at issue, and the scope of the claim would thus be unclear. Appropriate correction is thus required.
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 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 M.P.E.P. § 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.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2020/0342974 describes raising an alarm as a result of mathematical calculations.
U.S. Patent App. Pub. No. 2020/0268968 describes using a multivariate statistical model for predicting therapy adjustment, as well as raising an alarm, but does not describe determining an average deviation from the expected blood glucose reading given by the models over a predetermined period of time.
U.S. Patent App. Pub. No. 2020/0282141 describes the computation of a physiological model of glucose-insulin system in a patient to determine a predicted glucose level, which includes computing a plurality of ratios of variations of the predicted glucose level to variations of the sub-cutaneous quantity of insulin, but does not describe determining an average deviation from the expected blood glucose reading given by the models over a predetermined period of time.
The balance of the documents cited with this Office Action relate generally to the use of mathematical models in the control of insulin delivery devices.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783