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 .
Claim Status
Claims 1-15 are currently pending and under exam herein.
Claims 1-15 are rejected.
Claims 9 is objected to.
Priority
Applicant’s claim for priority to the earlier filed foreign application FR2209157, filed September 13, 2022, under 35 U.S.C. 119 (a)-(d) is acknowledged. Receipt of certified copies of papers required by 37 CFR 1.55 is acknowledged. At this point in examination, the effective filing date of claims 1-15 is September 13, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 13, 2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because it contains legal phraseology (e.g., said system, said storage module, etc.). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 9 is objected to because of the following informalities: the phrase “expected glucose” is repeated twice, the claim should be amended to only recite the phrase once. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1:
A storage module, said storage module storing a time series of glucose value of the user in a glucose storage.
An expectation module, said expectation module determining an expected glucose variation for a given time point.
An estimation module, said estimation module estimating the size of the unannounced meal ingested based on: a variation difference between a measured glucose variation between a glucose value at the given time point and a glucose value at a time point of the time series anterior to the given time point, the glucose values being acquired by a glycemia acquisition system or stored in the glucose storage; and the expected glucose variation between the glucose value at the given time point and the glucose value at the time point of the time series anterior to the given time point; at least one user parameter relative and personalized to the user.
Claim 2:
The expectation module is determining the expected glucose variation at the given time point based at least on: an insulin sensitivity factor relative to the user, and/or an instantaneous consumption of insulin by the user.
Claim 4:
A first estimation safety module, said first estimation safety module determining: if the measured glucose variation determined by the estimation module exceeds a variation difference threshold value and setting the measured glucose variation at a value equal to the variation difference threshold value if the measured glucose variation determined by the estimation module exceeds the variation difference threshold value.
Claim 5:
A second estimation safety module, said second estimation safety module determining: if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and setting the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value.
Claim 7:
A correction module, said correction module correcting the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age, a weight, a sex of the user and/or insulin needs of the user.
Claim 8:
An aggressiveness module, said aggressiveness module calculating a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module.
Claim 9:
A storage module adapted to store a time series of glucose value of the user in a glucose storage.
An expectation module adapted to determine an expected glucose expected glucose variation for a given time point.
An estimation module adapted to estimate the size of the unannounced meal ingested based on: a variation difference between a measured glucose variation between a glucose value at the given time point and a glucose value at a time point of the time series anterior to the given time point, the glucose values being acquired by a glycemia acquisition system or stored in the glucose storage; and the expected glucose variation between the glucose value at the given time point and the glucose value at the time point of the time series anterior to the given time point; at least one user parameter relative and personalized to the user.
Claim 10:
A first estimation safety module adapted to: determine if the variation difference determined by the estimation module exceeds a variation difference threshold value and to set the variation difference at a value equal to the variation difference threshold value if the variation difference determined by the estimation module exceeds the variation difference threshold value.
Claim 11:
A second estimation safety module adapted to: determine if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and to set the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value.
Claim 13:
A correction module adapted to correct the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age, a weight, a sex of the user and/or insulin needs of the user.
Claim 14:
An aggressiveness module adapted to calculate a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Paragraphs 0110-0115 of the published specification indicate the modules are computerized. MPEP 2181(II)(B) requires an algorithm to be disclosed as part of the structure in addition to the computer components for computer-implemented means-plus-function limitations. The sections in the published specification disclosing the algorithms for the above recited means-plus-function limitations are:
Claim 1:
Paragraphs 0125-0134 for the expectation module determining an expected glucose variation for a given time point.
The recited limitations in claim 1 for the said estimation module estimating the size of the unannounced meal ingested.
Claim 2:
Paragraphs 0125-0134 for the expectation module determining an expected glucose variation for a given time point based at least on: an insulin sensitivity factor relative to the user, and/or an instantaneous consumption of insulin by the user.
Claim 4:
Paragraphs 0142-0152 for the first estimation safety module determining if the measured glucose variation determined by the estimation module exceeds a variation difference threshold value and setting the measured glucose variation at a value equal to the variation difference threshold value if the measured glucose variation determined by the estimation module exceeds the variation difference threshold value.
Claim 5:
Paragraphs 0142-0152 for the second estimation safety module determining if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and setting the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value.
Claim 7:
Paragraphs 0154-0157 for the correction module correcting the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age, a weight, a sex of the user and/or insulin needs of the user.
Claim 8:
Paragraphs 0158-0160 for the aggressiveness module calculating a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module.
Claim 9:
Paragraphs 0125-0134 for the expectation module determining an expected glucose variation for a given time point.
The recited limitations in claim 1 for the said estimation module estimating the size of the unannounced meal ingested.
Claim 10:
Paragraphs 0142-0152 for the first estimation safety module determining if the measured glucose variation determined by the estimation module exceeds a variation difference threshold value and setting the measured glucose variation at a value equal to the variation difference threshold value if the measured glucose variation determined by the estimation module exceeds the variation difference threshold value.
Claim 11:
Paragraphs 0142-0152 for the second estimation safety module determining if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and setting the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value.
Claim 13:
Paragraphs 0154-0157 for the correction module correcting the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age, a weight, a sex of the user and/or insulin needs of the user.
Claim 14:
Paragraphs 0158-0160 for the aggressiveness module calculating a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-15 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.
Regarding claims 1-8 and 15, the claims are directed to a method for estimating a size of an unannounced meal implemented by a system, but do not recite any steps. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness (MPEP 2173.05(q)). For the purposes of examination, it will be interpreted that the steps of the method are a system performing the capabilities of the claimed system in the limitations. Additionally, it is unclear if only one of: a variation difference or at least one user parameter is required by the claim to estimate the size of the unannounced meal; or if both claim limitations are required to estimate the meal size because there is no conjunction between the limitations (e.g., and/or).
Regarding claims 9-14, claim 9 is rendered indefinite for the same reason as claim 1 because it is not clear if the meal estimation is based on both a variation difference and one user parameter or if only one of those limitations is required to estimate the meal size. Claims 10-14 are also rejected because they depend from claim 9 and do not resolve the issue of indefiniteness.
Regarding claim 12, there is insufficient antecedent basis for the limitation "the meal estimation threshold value.” For the purposes of examination, it will be treated as the first recitation of the limitation. It is suggested to amend the claim to depend from claim 11 to overcome this rejection.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Step 1:
The first part of the eligibility analysis evaluates whether a claim falls within any statutory category (MPEP 2106.03). Claims 1-15 are directed to statutory categories on invention (Step 1: YES).
Step 2A, prong 1:
In accordance with MPEP 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, prong 1). In the instant application, the claims recite the following limitations that equate to those concepts:
Claims 1 and 15 recite: … determining an expected glucose variation for a given time point; … estimating the size of the unannounced meal ingested based on: a variation difference between a measured glucose variation between a glucose value at the given time point and a glucose value at a time point of the time series anterior to the given time point, the glucose values being acquired by a glycemia acquisition system or stored in the glucose storage; and the expected glucose variation between the glucose value at the given time point and the glucose value at the time point of the time series anterior to the given time point; at least one user parameter relative and personalized to the user.
Claim 2 recites: … determining the expected glucose variation at the given time point based at least on: an insulin sensitivity factor relative to the user, and/or an instantaneous consumption of insulin by the user.
Claim 3 recites: wherein the user parameter relative and personalized to the user is based on the weight of the user.
Claim 4 recites: … determining: if the measured glucose variation determined by the estimation module exceeds a variation difference threshold value and setting the measured glucose variation at a value equal to the variation difference threshold value if the measured glucose variation determined by the estimation module exceeds the variation difference threshold value.
Claim 5 recites: … determining: if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and setting the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value.
Claim 6 recites: wherein the meal estimation threshold value is calculated based on a threshold parameter determined based on the given time point.
Claim 7 recites: … correcting the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age, a weight, a sex of the user and/or insulin needs of the user.
Claim 8 recites: … calculating a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module.
Claim 9 recites: … determine an expected glucose expected glucose variation for a given time point; … estimate the size of the unannounced meal ingested based on: a variation difference between a measured glucose variation between a glucose value at the given time point and a glucose value at a time point of the time series anterior to the given time point, the glucose values being acquired by a glycemia acquisition system or stored in the glucose storage; and the expected glucose variation between the glucose value at the given time point and the glucose value at the time point of the time series anterior to the given time point; at least one user parameter relative and personalized to the user.
Claim 10 recites: … determine if the variation difference determined by the estimation module exceeds a variation difference threshold value and to set the variation difference at a value equal to the variation difference threshold value if the variation difference determined by the estimation module exceeds the variation difference threshold value.
Claim 11 recites: … determine if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and to set the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value.
Claim 12 recites: wherein the meal estimation threshold value is calculated based on a threshold parameter determined based on the given time point.
Claim 13 recites: … correct the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age, a weight, a sex of the user and/or insulin needs of the user.
Claim 14 recites: … calculate a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module.
The limitations in claims 1, 9, and 15 of determining an expected glucose variation for a given time point encompasses a mental process of evaluating information and forming a conclusion. The limitations of estimating the size of an unannounced meal based on a variation difference and a user parameter encompasses mathematical calculations that can be performed in the mind with the aid of pen and paper.
The limitations in claims 2 of determining an expected glucose variation based on insulin sensitivity factor or consumption of insulin further limit the mental process in claim 1 of evaluating and forming a conclusion by indicating which information is to be used. Likewise, the limitation in claim 3 further limits the mathematical calculations in claim 1 of estimating meal size by using weight as the parameter in the calculation.
The limitations in claims 4-5 and 10-11 of determining if values exceed a threshold and setting values equal to the thresholds are mental processes of observing data and changing values. The limitations in claims 6 and 12 recite mathematical calculations performed to arrive at the threshold values. Lastly, the limitations in claims 7-8 and 13-14 of calculating aggressiveness estimations and correcting the estimated size are verbal recitation of mathematical calculations.
Therefore, these limitations fall under the “Mathematical concepts” and “Mental processes” groupings of abstract ideas (Step 2A, prong 1: YES).
Step 2A, prong 2:
Claims found to recite a judicial exception under Step 2A, prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application (Step 2A, prong 2). The claims recite the following additional elements:
Claims 1, 9, and 15 recite: … a system comprising: a storage module, said storage module storing a time series of glucose value of the user in a glucose storage, an expectation module, … and an estimation module…
Claims 4 and 10 recite: … a first estimation safety module….
Claims 5 and 11 recite: … a second estimation module…
Claims 7 and 13 recite: … a correction module…
Claim 8 and 14 recite: … an aggressiveness module…
Claim 15 recites: … a processor…
The additional elements in claims 1, 9, and 15 of a storage module is insignificant extra-solution activity that is mere data gathering for the required data to be used by the judicial exception (MPEP 2106.05(g)). The remaining additional elements in claims 1, 4-5, 7-11, and 13-15 of the various modules and the processor are instructions to apply the judicial exception to a generic computer environment (MPEP 2106.05(f)).
Therefore, the judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies/uses the recited judicial exception in some other meaningful way and the claims are directed to the judicial exception (Step 2A, prong 2: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims recite additional elements that equate to mere instructions to apply the recited judicial exception in a generic computing environment. Claims that amount to nothing more than instructions to apply the judicial exception using a generic computer do not render an abstract idea eligible. Alice Corp., 576 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. The additional elements recited in the claims amount to well-understood, routine and conventional (WURC) activity because claims recite computer functions that the courts have ruled to be WURC such as storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
As such, the combination of additional elements recited in the claims is well-understood, routine, and conventional. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transform the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO) and claims 1-15 are not patent eligible.
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.
Claims 1-5, 9-11, and 15 are rejected under 35 U.S.C. 102(a)(1) & (a)(2) as being anticipated by El Fathi et al. (US20220280720A1; IDS document 9/13/2023).
Regarding claim 1, El Fathi et al. teach an electronic device (Fig. 1) that detects unknown meals based on a model of a user’s glucoregulatory system generated using historical data of the user (paragraphs 0110-0112). The glucoregulatory system is represented by a state-space model which receives a series of past glucose measurements, and, in some embodiments, the system is used to estimate a meal size (paragraphs 0057, 0115, 0128). These teachings disclose the claim 1 limitations a method for estimating a size of an unannounced meal ingested by a user, the method being implemented by a system, said system comprising: a storage module, said storage module storing a time series of glucose value of the user in a glucose storage… El Fathi et al. teach the glucoregulatory system model predicts glucose measurements of the user (paragraph 0112) using model parameters that can represent the observed glucose measurements and determine state estimates depending on previous values and values of input variables (paragraph 0124). The internal state of the model may be represented by various measurements such as concentration of plasma insulin, amount of digested meals, glucose plasma concentration, etc. (paragraph 0117). These teachings disclose the claim 1 limitations of … an expectation module, said expectation module determining an expected glucose variation for a given time point…
El Fathi et al. teach the meal detection procedure compares predicted glucose measurements with current glucose measurements received from a continuous glucose monitor (CGM) and determines if a meal has not been logged by the user (paragraphs 0112, 0127-0128). The comparison is a difference between the actual glucose measurement and the predicted glucose measurement which quantifies by how much the actual glucose measurement differs from the predicted measurement (paragraph 0137). El Fathi et al. also teach that the state-model of the user’s glucoregulatory system may receive a priori model parameters based on specific characteristics of the patient that are used to predict glucose values (paragraph 0143). After a meal has been detected, its’ size is determined (paragraph 0188). Together these teachings disclose the claim 1 limitations of … an estimation module, said estimation module estimating the size of the unannounced meal ingested based on: a variation difference between a measured glucose variation between a glucose value at the given time point and a glucose value at a time point of the time series anterior to the given time point, the glucose values being acquired by a glycemia acquisition system or stored in the glucose storage; and the expected glucose variation between the glucose value at the given time point and the glucose value at the time point of the time series anterior to the given time point; at least one user parameter relative and personalized to the user.
Although the method in El Fathi et al. compares the difference between an actual glucose value and a predicted value instead of the difference between measured glucose variation between two time points and the expected glucose variation between two times points, the teaching is functionally equivalent to the claimed limitations because they perform an identical function substantially in the same way (MPEP 2183).
For example, consider hypothetical glucose measurements of 5 mmol/L at time = 1, measured glucose of 10 mmol/L at time = 2, and expected glucose of 8 mmol/L at time = 2.
The measured glucose variation between times 2 and 1 is 10 – 5 = 5, the expected glucose variation is 8 – 5 = 3, and the difference between the variations would be 5 – 3 = 2.
When taking the difference of only the measured glucose value and the expected glucose value the answer is the same 10 – 8 = 2. Since both the measured glucose variation and the expected glucose variation are compared to the same anterior time point, the real comparison is just the change of the actual measured blood glucose and the expected blood glucose level.
Regarding claims 9 and 15, the foregoing teachings of El Fathi et al. also read on all the limitation of the system in claim 9 and Figure 1 shows the electronic device is a computer which discloses the claim 15 limitations of a computer program for estimating a size of an unannounced meal ingested by a user wherein the computer program is adapted, when run on a processor, to cause the processor to implement the method of the claim 1.
Regarding claims 2-3, El Fathi et al. teach user-specific parameters that may be used to model the glucoregulatory system of the user include: patient insulin sensitivity, insulin absorption rate, patient weight, etc. (paragraph 0103) which discloses the claim 2 limitations of where the expectation module is determining the expected glucose variation at the given time point based at least on: an insulin sensitivity factor relative to the user, and/or an instantaneous consumption of insulin by the user and the claim 3 limitation of wherein the user parameter relative and personalized to the user is based on the weight of the user.
Regarding claims 4 and 10, El Fathi et al. teach the innovation parameter used to determine a mismatch between the actual glucose value and the predicted measurement may be determined based on a threshold where if the difference between the actual and predicted measurement breaches a threshold, the innovation parameter is rounded to another value and thus the actual and predicted glucose measurements may be considered equal within a given range (paragraph 0140) which discloses the claim 4 limitations of wherein the system is further comprising a first estimation safety module, said first estimation safety module determining: if the measured glucose variation determined by the estimation module exceeds a variation difference threshold value and setting the measured glucose variation at a value equal to the variation difference threshold value if the measured glucose variation determined by the estimation module exceeds the variation difference threshold value and the same claim 10 limitations.
Regarding claims 5 and 11, El Fathi et al. teach the insulin bolusing determination procedure determines a meal size and updates the glucoregulatory system model to a more accurate state of the patient (paragraphs 0188-0189). The procedure estimates a remaining undigested meal size which may be capped to a given value for patient safety (Id.) which discloses the claim 5 limitations of wherein the system is further comprising a second estimation safety module, said second estimation safety module determining: if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and setting the size at a value equal to the meal estimation threshold value if the size of the unannounced meal ingested estimated by the estimation module exceeds a meal estimation threshold value and the same claim 11 limitations.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over El Fathi et al. (US20220280720A1; IDS document 9/13/2023) as applied to claims 1, 5, and 9 above, and further in view of Siket et al. (2022 13th Asian Control Conference (ASCC), pp. 1367-72; IDS document 9/13/2023). The italicized text corresponds to the instant claim limitations.
The limitations of claims 1, 5, and 9 were taught by El Fathi et al.
El Fathi et al. appears to be silent on the limitations of claims 6 and 12. However, these limitations were known in the prior art at the effective filing date of the invention as taught by Siket et al.
Regarding claims 6 and 12, Siket et al. teach estimation errors for carbohydrate (CHO) content significantly dropped as time from meal ingestion increased (p. 1370-1371, III. Results, paragraph 4; Figure 4) and after 30 minutes the median error is lower than the error of patient reported CHO content (p. 1371, IV. Discussion, paragraph 1). These teachings disclose the limitations of claim 6 wherein the meal estimation threshold value is calculated based on a threshold parameter determined based on the given time point and the same limitations of claim 12.
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. Siket et al. teach that the CHO counting accuracy of patients can be achieved or surpassed with sufficient data and despite the large uncertainty in CHO content of a meal, the model predictive control-moving horizon estimation (MPC-MHE) control strategy is able to be used safely (p. 1371-1372, V. Conclusion). El Fathi et al. teach using the estimated meal size to calculate an insulin bolus to control the patient’s blood glucose (paragraph 0190). Therefore, one of ordinary skill in the art would have been motivated to incorporate determining a meal estimation threshold value based on a certain time point in order calculate the appropriate insulin bolus to avoid a hypoglycemic or hyperglycemic state because the threshold value could be more precisely tuned. Furthermore, one of ordinary skill in the art would predict time-dependent threshold values could be readily added to the device of El Fathi et al. with a reasonable expectation of success because both references are using artificial pancreas systems (El Fathi et al., paragraph 0002; Siket et al., Abstract). The invention of claims 6 and 12 are therefore prima facie obvious.
Claims 7-8 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over El Fathi et al. (US20220280720A1; IDS document 9/13/2023) as applied to claims 1 and 9 above, and further in view of Samadi et al. (IEEE Journal of Biomedical and Health Informatics, vol. 21, no. 3, pp. 619-27). The italicized text corresponds to the instant claim limitations.
The limitations of claims 1 and 9 were taught by El Fathi et al.
El Fathi et al. appears to be silent on the limitations of claims 7-8 and 13-14. However, these limitations were known in the prior art at the effective filing date of the invention as taught by Samadi et al.
Regarding claims 7 and 13, Samadi et al. teach training individual-specific parameters for meal size estimation (CHO) based on the age of patients (p. 624-625, V. Simulations and Results, paragraphs 1-2) which discloses the claim 7 limitations of wherein the system is further comprising a correction module, said correction module correcting the estimated size of the unannounced meal ingested estimated by the estimation module according to at least one correction coefficient, the at least one correction coefficient being predetermined according to a user profile based at least on an age… of the user and the same limitations of claim 13.
Regarding claims 8 and 14, Samadi et al. teach a patient-specific parameter β (p. 624, C. Meal Size Estimation, paragraph 3; Table III) which discloses wherein the system is further comprising an aggressiveness module, said aggressiveness module calculating a customized aggressiveness estimation of the size of the meal by applying an aggressiveness factor to the estimation size of the unannounced meal ingested estimated by the estimation module and the same limitations of claim 14.
An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. El Fathi et al. teach using the estimated meal size to calculate an insulin bolus to control the patient’s blood glucose (paragraph 0190) and having a cap for meal size to prevent overdosing of insulin while finding a balance of time spent in hyperglycemia (paragraph 0220). Samadi et al. teach that patient-specific parameters allow for maintaining glucose concentrations (GC) that are individualized for different people and optimization of parameters enhance the accuracy of meal estimation that improves GC control (p. 626, VI. Discussion).
In light of the foregoing prior art teachings, one of ordinary skill in the art would have been motivated to incorporate correction/aggressiveness factors in the meal estimation procedure of El Fathi et al. in order to increase the accuracy of the prediction algorithm and calculate the appropriate insulin bolus to administer and control the blood glucose of a patient. Furthermore, one of ordinary skill in the art would predict correction/aggressiveness factors could be readily added to the meal estimation procedure in El Fathi et al. with a reasonable expectation of success because El Fathi et al. already teach user-specific parameters to model a patients glucoregulatory system to increase the accuracy of the detected blood glucose concentrations (paragraph 0103). The invention of claims 7-8 and 13-14 is therefore prima facie obvious.
Conclusion
No claims are allowed.
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/T.Y.O./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
