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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2 December 2025 has been entered.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites the term “fstep”; it is unclear if this is a typographical error or if the intent is to define a new word.
Appropriate correction is required.
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, 3-6, 9, and 10 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.
The formatting of claim 1 is entirely unclear; the newly added limitation beginning “the insulin injection control device is controlled” appears to be part of the bulleted list a, b, c which defines the steps of a method, as the list is presented a, b, c, and the insulin injection control device.
The newly added final limitation appears to further define parts of the method step c, but is presented entirely separately, but also is not recited as “further configured to” such that it is unclear if this is an alternate step c or if this is in addition to the tasks already performed as part of step c.
Further, claim 1 does not include an “and” before the final clause after the “wherein” such that it is unclear if an additional limitation has been excluded.
Claim 1 in step c recites “activating a meal management module of the automated blood glucose regulation system”; as the claim as a whole is directed to “Automated blood glucose regulation system, comprising: a blood glucose sensor; an insulin injection device; and a processing and control unit”, none of which are or include “a meal management module”, it is unclear how this module relates to any part of the system which has actually been defined. Clarification is required.
Claim 1 in the final clause recites “the meal size is estimated”; step c indicates that an estimated size of the meal is read in a table, but does not include an active step of performing an estimation, only reading a value from a table. It is unclear if there should be an additional computation performed in the system for actively estimating the size, or if this refers only to the step of reading an estimated value from the table. Clarification is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 is directed only to the step of determining an insulin bolus to be injected, which is already recited in the final clause of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1, 3-6, 9. 10 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “configured to implement… the steps of” “detecting…an event”, “when an event is detected… read in a first table… a probability for a meal”, “if the probability… is greater than a threshold… read, in the first table, an estimated time slot… and read, in a second table… an estimated size of the meal”, “determine… an insulin bolus to be injected”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. The recited “control” of the insulin injection device to deliver a determined bolus appears to be an attempt to recite a particular treatment or prophylaxis; however, as there is insufficient specificity as to how the treatment is determined or how it relates to the abstract idea itself, merely “controlling” delivery of an unspecified amount of treatment or treatment with an undefined relationship to the abstract idea is not a particular treatment or prophylaxis. The recited processor merely provides a technological environment for execution of the abstract idea itself, and use of a memory to store data such as the first and second tables is merely providing a technological environment for execution of the abstract idea itself, where these tables could equally be on paper. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a blood glucose sensor, an insulin injection device, and a processing and control unit with a memory circuit, where the insulin injection device is controlled to inject the determined insulin bolus. However, these elements are not “significantly more”. The recited processing and control unit with memory circuit are are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. The blood glucose sensor is recited at a high level of generality and only for the purpose of insignificant extrasolution data gathering; see MPEP 2106.05(d), where determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional. The insulin injection device and its operation (control) is also recited at a high level of generality and only for the postsolution activity of indicating a field of use (see also a step of administering a drug to patients, Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78, 101 USPQ2d 1961, 1968 (2012)). Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 3-6, 9, and 10 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Claims 3, 4 are also directed to additional aspects of the abstract idea itself; claim 5 recites the presence of an interface that is not related to the abstract idea; claim 6 is directed to additional insignificant extrasolution data gathering; claims 9 and 10 are directed to determination using the gathered data. Thus, claim(s) 1, 3-6, 9, and 10 is/are rejected under 35 U.S.C. 101.
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) 1-5 and 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abraham (US 2017/0049386) in view of Shalon (US 2006/0064037).
Regarding claims 1 and 9, Abraham discloses an automated blood glucose regulation system, comprising:
a blood glucose sensor (element 104);
an insulin injection device (element 102); and
a processing and control unit (element 106),
wherein the processing and control unit is configured to implement a method of management of undeclared meals (paragraphs [0006]-[0007]) and control the insulin injection device (paragraph [0100]), this method comprising the steps of:
a) detecting, at a time t0, an event likely to correspond to a meal non-declared by a user based on measurements performed by the blood glucose sensor (paragraph [0030]-[0031]);
b) when an event is detected at step a), reading a first table generated by training from a history of the user's data and stored in a memory circuit of the processing and control unit, a probability for a meal to have been taken by the user within a period T_ANT of predetermined duration preceding time t0 (paragraphs [0031]-[0032], [0042], [0044], [0047]-[0049]);
c) if the probability of step b) is greater than a threshold TH, reading, in the first table, an estimated time slot of meal ingestion by the user within period T_ANT and, then activating a “meal management module” of the automated blood glucose regulation system and transmitting to said module the estimated time slot of the meal (paragraphs [0047]-[0049]), determining, by means of the “meal management module”, an insulin bolus to be injected into the user according to the data received by the “meal management module” (paragraphs [0060], [0130]-[0133]), and controlling the insulin injection device to inject the insulin bolus (paragraphs [0130]-[0133]), such that the insulin injection control device is controlled in response to the data transmitted to the “meal management module” (paragraphs [0130]-[0133]);
where the first table is formed of a series of probability values, each corresponding to a percentage of times that a meal has been declared by the user within a determined time interval of a determined time cycle, during a training phase comprising a plurality of occurrences of said time cycle (paragraphs [0041], [0042], [0047]-[0049]).
Abraham is not explicit as to the system being further configured to determine an estimated size of the meal from a second table generated by training from the history of the user’s data, the table being formed of a series of meal size values, with that estimated size also being transmitted to the meal management module.
Shalon teaches a physiological regulation system comprising a processing and control unit (paragraph [0235]) configured to detect, from measurements, an event likely to correspond to a meal non-declared by a user during a particular time period, and to find, in a table, a relationship between the time period and an estimated size of the likely meal, where only the table values of time period and meal size are used to find the estimated size of the likely meal (paragraph [0162] – “Since the system will be able to keep track of time and a usage history, it can use average caloric consumption values from previous usage data for the skipped measurements.”). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Abraham and configured it to also determine and transmit an estimated size of the meal using average meal sizes during intervals of the training phase, as taught by Shalon, in order to more accurately determine a necessary correction bolus.
Regarding claim 3, Abraham further discloses that the first time cycle is divided into a plurality of time intervals, the number of values of the tables used for identification being equal to the number of time intervals of said time cycle (paragraphs [0047]-[0049]).
Regarding claim 4, Abraham further discloses that if the probability determined at step b) is lower than threshold TH, the system is further configured to implement a “blood glucose regulation method” non-specific to meals (paragraph [0058]; figure 6, step 612, the “no” outcome).
Regarding claim 5, Abraham further discloses a user interface device coupled to the processing and control unit (paragraph [0118]).
Regarding claim 10, Abraham further discloses that the “meal management module” is configured to weigh said bolus by a coefficient which is a function of the probability determined at step b) (paragraphs [0130]-[0133]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abraham, as modified and applied above, and further in view of Budiman (US 2017/0185748).
Regarding claim 6, Abraham, as modified, does not explicitly disclose that the processing and control unit is configured to, when an event is detected at step a), implement, before step b), a “first step” of interrogation of the user, by means of the user interface device, to ask them whether they have had an undeclared meal within period T_ANT. Budiman teaches a blood glucose regulation system that is configured to detect an event likely to correspond to a meal non-declared by a user, and, in response, ask the user via a user interface whether they have had an undeclared meal (paragraph [0085]-[0086]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Abraham, as modified above, and included a step of querying a user about a potential meal event, as taught by Budiman, in order to reduce the need for calculating probabilities.
Response to Arguments
Applicant's arguments filed 3 November 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 101, Applicant provides a general assertion that the claims as a whole recite statutory subject matter, without any discussion of how or why this might be the case beyond a summary of claim 1 in its entirety; as Applicant’s general assertion does not address any of the aspects of patent subject matter eligibility as clearly set forth in MPEP 2106 and the Office’s numerous guidance updates, the general assertion of eligibility is entirely unpersuasive.
Applicant’s arguments with respect to the art rejections of the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s remarks address only the newly presented limitations and how Desborough, no longer applied against the claims, relates to those limitations; as the claims and all limitations are rejected under Abraham in view of Shalon above, these remarks are moot.
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791
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