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 1-12 are currently pending and under examination herein.
Claims 1-12 are rejected.
Priority
The instant application claims foreign priority to FR2209159 filed 13 September 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. In this action, claims 1-12 are examined as though they had an effective filing date of 13 September 2022. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further analysis of the disclosure(s) of the priority application(s).
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 13 September 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on 13 September 2023 and 16 October 2023 are accepted.
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 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:
112(f) Invocation
Claims Present
detection module
1, 11
estimation module
1, 11
compensation module
1, 2, 7, 9, 11
condition module
2
estimation safety module
4
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. The modules are interpreted as generic computer processing systems with support for the required algorithms provided (see table below).
112(f) Invocation
Support for computer implementation (¶)
Support for Algorithm (¶)
detection module
0098
0234
estimation module
0098
0106
compensation module
0098
0030
condition module
0098
0244
estimation safety module
0098
0126
No additional support for computer implantation or any other structure for the modules was found within the discourse.
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.
Claims 3 and 5-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 recites “at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value”. With the colon after “is”, it is unclear if “a variable IOB(t)” is a possible condition or just introduces the first condition of “is lower than a predetermined value”. The way the claim is presented make it unclear if there are two or three conditions presented to select between. The metes and bounds are unclear rendering the claim indefinite. For the purposes of examination, there are three choices of condition to choose between A) a variable IOB(t), representative of the time variation of the user's quantity of insulin on board; B) is lower than a predetermined value; C) a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 5 and 6 recite the broad recitations - number of times is comprised between (Claim 5) and time periodicity is comprised between (claim 6). The claims also recites preferably and even more preferably ranges which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of exemption, each range listed is considered a possibility.
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 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim does not fall within at least one of the four categories of patent eligible subject matter because it recites computer program executed by a processor. Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations are not directed to any of the statutory categories (MPEP 2106.03). This rejection can be overcome by having the program code stored on non-transitory memory and executed by the processor.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Despite claim 12 not being directed to a statutory category of invention (see 101 above), in the interest of compact prosecution claim 12 is included in the subject matter eligibility analysis. 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 (Step 2A, Prong 1). Claims 1-10 are directed to a system and Claim 11 is directed to a method. In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1 recites the limitation – implement a detection step consisting of detecting an unannounced meal at an initial time-point; and implement an estimation step consisting of estimating the size of the unannounced meal. Based on the broadest reasonable interpretation, detecting a meal and estimating the size of a meal could practically be done by the human mind. This draws the limitation to a mental process, which classifies the limitation as an abstract idea. The claim also recites implement a calculation step consisting of calculating an amount of insulin at least based on the estimated size of the unannounced meal. Based on the broadest reasonable interpretation, calculating the amount encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea. The claim also recites repeat the estimation step and the calculation step for a determined number of times with a determined time periodicity. This limitation specifies repeating the judicial exceptions indicated above. Therefore it recites the indicated judicial exceptions.
Claim 2 recites the limitation - verify whether at least one condition is met. Based on the broadest reasonable interpretation, verifying a condition could practically be done by the human mind. This draws the limitation to a mental process, which classifies the limitation as an abstract idea. The claim also recites the calculation step being implemented if the at least one condition is met. Based on the broadest reasonable interpretation, the calculating encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 3 recites the limitation - wherein one of the at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value. This limitation specifies the conditions verified in the judicial exception of claim 2. The refined verifying indicated by this limitation still represents a judicial expectation. Additionally, the limitation the verification encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 4 recites the limitation - determine whether the estimated size of the unannounced meal exceeds a meal estimation threshold value and set the estimated size at a value equal to the meal estimation threshold value if the estimated size of the unannounced meal exceeds the meal estimation threshold value. Based on the broadest reasonable interpretation, determining the size compared to a threshold and setting a value encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 5 recites the limitation - wherein the determined number of times is comprised between 2 and 10, preferably between 3 and 5, even more preferably equal to 4. This limitation specifies the timing of the estimating and calculating in the judicial exception of claim 1. The refined estimating and calculating indicated by this limitation still represents a judicial expectation.
Claim 6 recites the limitation - wherein the determined time periodicity is comprised between 1 and 15 minutes, preferably between 1 and 10 minutes, even more preferably equal to 5 minutes. This limitation specifies the timing of the estimating and calculating in the judicial exception of claim 1. The refined estimating and calculating indicated by this limitation still represents a judicial expectation.
Claim 7 recites the limitation - wherein the amount of insulin calculated at each calculating step comprises a residual component, the residual component being calculated by the compensation module according to a residual part based on: at least one previous estimated size of a previous unannounced meal; and a predetermined ingestion profile relative and personalized to the user. This limitation specifies the components of the calculating in the judicial exception of claim 1. The refined determination indicated by this limitation still represents a judicial expectation. Based on the broadest reasonable interpretation, calculating the components encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 8 recites the limitation - wherein the amount of insulin calculated comprises a meal component, the meal component being calculated by the compensation module according to a predetermined meal ratio and the estimated size of the unannounced meal. This limitation specifies the components of the calculating in the judicial exception of claim 1. The refined determination indicated by this limitation still represents a judicial expectation. Based on the broadest reasonable interpretation, calculating the components encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 9 recites the limitation - wherein the amount of insulin calculated comprises a net IOB component, the net IOB component being calculated by the compensation module according to a net insulin-on-board of the user. This limitation specifies the components of the calculating in the judicial exception of claim 1. The refined determination indicated by this limitation still represents a judicial expectation. Based on the broadest reasonable interpretation, calculating the components encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 10 recites the limitation - wherein the value of the net IOB component is equal to zero if the net insulin-on-board is negative or null. This limitation specifies the calculating in the judicial exception of claim 9. The refined determination indicated by this limitation still represents a judicial expectation.
Claim 11 recites the limitation - detects an unannounced meal at an initial time-point; and implements the estimation step. Based on the broadest reasonable interpretation, detecting a meal and estimating the size of a meal could practically be done by the human mind. This draws the limitation to a mental process, which classifies the limitation as an abstract idea. The claim also recites implements the calculation step. Based on the broadest reasonable interpretation, calculating the amount encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea. The claim also recites the estimation and the calculation step being repeated for a determined number of times with a determined time periodicity. This limitation specifies repeating the judicial exceptions indicated above. Therefore it recites the indicated judicial exceptions.
Claim 12 recites the limitation - estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user and implement the method of the claim 11. This claim recites the judicial exceptions of claim 11.
These limitations recite concepts of detect, determine, estimate, and calculate information and values that are so generically recited that they can be practically performed in the human mind as claimed, which falls under the “Mental processes” and “Mathematical concepts” grouping of abstract ideas. A mathematical concept need not be expressed in mathematical symbols, because words used in a claim operating on data to solve a problem can serve the same purpose as a formula (MPEP 2106.04(a)(2)). Additionally, both product claims and process claims may recite mental processes, which can include a claim that requires a computer (MPEP 2106.04(a)(2)). Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. As such, claims 1-12 recite an abstract idea (Step 2A, Prong 1: YES).
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 or not (Step 2A, Prong 2). These judicial exceptions are not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology (MPEP 2106.04(d)(1)) or particular treatment (MPEP 2106.04(d)(2)). Rather, the claims provide insignificant extra-solution activity (MPEP § 2106.05(g)) and provide mere instructions to apply a judicial exception (MPEP § 2106.05(f)). Specifically, the claims recite the following additional elements:
Claim 1 recites a detection module, an estimation module; a compensation module.
Claim 2 recites a condition module.
Claim 4 recites an estimation safety module.
Claim 12 recites computer program and a processor.
There are no limitations that indicate that the claimed detect, determine, estimate, and calculate information and values require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible. There is no indication that these steps are affected by the judicial exception in any way and thus do not integrate the recited judicial exception into a practical application. While the claims estimate an amount insulin needed, they do constitute a particular treatment is indicated by MPEP 2106.04(d)(2). However, if a step of administering the predicted treatment to the patient could be added to the independent claims, the invention would be considered to integrate a particular treatment as a practical application. As such, claims 1-12 are currently directed to an abstract idea (Step 2A, Prong 2: NO).
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 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite conventional additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The claims also recite conventional additional elements that represent insignificant extra-solution activities.
As discussed above, there are no additional limitations to indicate that the claimed detect, determine, estimate, and calculate information and values require anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea or natural law eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. As specified in MPEP 2106.05(g), extra-solution activities can be understood as incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Insignificant extra-solution activities include mere data gathering, selecting a particular data source or type of data to be manipulated, and displaying information. Additionally, Tyler et al. (2020, Sensors, Vol. 20: 1-26). Teach the use of general computing devices involved in estimating insulin needs related to meals are well understood, routine, and conventional (Page 7, Paragraph 7: Mobile DSSs are now becoming available for use by people with T1D who use either CSII or MDI and can potentially provide improvements in glycemic outcomes. Existing automated DSSs are designed to provide recommendations to people with T1D regarding insulin doses, anticipated hypoglycemia, and modifications to daily behaviors that may improve their glycemic outcomes).
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms 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). As such, Claims 1-12 are not patent eligible.
Claim Rejections - 35 USC § 102
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 1-4 and 7-12 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by El Fathi et al. (US 20220280720, from IDS 13 September 2023). Italicized text from reference art.
.
Applicable claims include:
Claim 1. A system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user, said system comprising (Claim 1.i) a detection module, said detection module being adapted to implement a detection step consisting of detecting an unannounced meal at an initial time-point; (Claim 1.ii) an estimation module, said estimation module being adapted to implement an estimation step consisting of estimating the size of the unannounced meal; (Claim 1.iii) a compensation module, said compensation module being adapted to implement a calculation step consisting of calculating an amount of insulin at least based on the estimated size of the unannounced meal, (Claim 1.iv) the estimation module and the compensation module being adapted to repeat the estimation step and the calculation step for a determined number of times with a determined time periodicity.
Claim 2. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, the system further comprising a condition module, said condition module being adapted to verify whether at least one condition is met, the calculation step being implemented by the compensation module if the at least one condition is met.
Claim 3. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 2, wherein one of the at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value.
Claim 4. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1 wherein the system further comprises an estimation safety module, said estimation safety module being adapted to determine whether the estimated size of the unannounced meal exceeds a meal estimation threshold value and set the estimated size at a value equal to the meal estimation threshold value if the estimated size of the unannounced meal exceeds the meal estimation threshold value.
Claim 7. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, wherein the amount of insulin calculated at each calculating step comprises a residual component, the residual component being calculated by the compensation module according to a residual part based on: at least one previous estimated size of a previous unannounced meal; and a predetermined ingestion profile relative and personalized to the user.
Claim 8. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, wherein the amount of insulin calculated comprises a meal component, the meal component being calculated by the compensation module according to a predetermined meal ratio and the estimated size of the unannounced meal.
Claim 9. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, wherein the amount of insulin calculated comprises a net IOB component, the net IOB component being calculated by the compensation module according to a net insulin-on-board of the user.
Claim 10. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 9 wherein the value of the net IOB component is equal to zero if the net insulin-on-board is negative or null.
Claim 11. A method for calculating an amount of insulin needed to compensate for an unannounced meal ingested by a user implemented by a system according to claim 1, the method comprising: the detection module detects an unannounced meal at an initial time-point; the estimation module implements the estimation step; the compensation module implements the calculation step; the estimation and the calculation step being repeated for a determined number of times with a determined time periodicity.
Claim 12. A computer program for estimating an amount of insulin needed to compensate for 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 11.
Regarding Claims 1, 11, and 12, El Fathi et al. teach (Claim 1.i) a detection module adapted to detecting an unannounced meal at an initial time-point (Paragraph 0013: identify unannounced meals; Paragraph 0042: the glucose change is indicative of an unknown meal, the unknown meal not having been logged by the subject; Paragraph 0101: The control procedure includes a meal detection procedure). El Fathi et al. teach (Claim 1.ii) an estimation module adapted to estimating the size of the unannounced meal (Paragraph 0027: determining an unknown meal amount; Paragraph 0032: the method further comprises estimating a meal size and a time of consumption of the meal). El Fathi et al. teach (Claim 1.iii) a compensation module adapted to calculating an amount of insulin at least based on the estimated size of the unannounced meal (Paragraph 0026: determining an insulin bolus of the unknown meal not having been logged by the given user; Paragraph 0027: prior to said determining the insulin bolus: determining, based on the innovation parameter and the innovation covariance parameter, an unknown meal amount; Paragraph 0033: determining the medication bolus is based, at least in part, on at least one of: the estimated meal size and the estimated time of consumption of the meal). El Fathi et al. teach (Claim 1.iv) the estimation module and the compensation module adapted to repeat the estimation step and the calculation step for a number of times with a time periodicity (Paragraph 0126: the equations are executed recursively; Paragraph 0152: Every M epochs, the state-space modeling procedure estimates the set of user parameters; Paragraph 0158: the state estimates at every iteration). Additionally, El Fathi et al. teach the methods are conducted by a generic computing device, which inherently contains code, memory, including non-transitory computer readable medium, to perform the recited function (Paragraph 0030: there is provided a computer-implemented method for detecting meals consumed by a patient, the method being executed by a processor; Paragraph 0084: Software modules, or simply modules which are implied to be software, may be represented herein as any combination of flowchart elements or other elements indicating performance of process steps and/or textual description. Such modules may be executed by hardware that is expressly or implicitly shown). This is interpreted as encompassing the modules recited by the claims (see 112(f) claim interpretation above). Claim 11 recites the limitations of claim 1 directed to a method. Claim 12 recites the limitations of claim 11 directed to a program executed by a processor.
Regarding Claim 2, El Fathi et al. teach a condition module adapted to verify whether at least one condition is met; and the calculation step being implemented by the compensation module if the at least one condition is met (Paragraph 0126: it is a set of equations implementing a predictor-corrector type estimator to minimize an estimated covariance when conditions are respected; Paragraph 0054: the method further comprises determining that a meal has been consumed in response to the determined probability breaching a threshold). In addition to El Fathi et al. describing a condition that must be met prior to the calculating, having to pass a threshold prior to the calculation is also interpreted as verifying whether a condition is met. The modules are interpreted as generic computing devise (see 112(f) claim interpretation), which are taught by El Fathi et al. (See regarding claim 1).
Regarding Claim 3, El Fathi et al. teach one of the at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value (Paragraph 0189: if m is an estimation of the remaining non-digested meal in the new patient state, the patient safety m may be capped to a give n value such as 20 g. The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor and the remaining insulin-on-board (IOB)). The system calculates a dose to be administered only if the IOB will not exceed a maximum value.
Regarding Claim 4, El Fathi et al. teach an estimation safety module adapted to determine whether the estimated size of the unannounced meal exceeds a meal estimation threshold value set the estimated size at a value equal to the meal estimation threshold value if the estimated size of the unannounced meal exceeds the meal estimation threshold value (Paragraph 0220: Since the remaining meal size m is capped to a small CHO value (20 g in this case), the risk of overdosing insulin is minimized; Paragraph 0140: It will be appreciated that the innovation parameter indicative of the mismatch between the actual glucose measurement, and the predicted measurement may be determined in various ways, and corrective factors or thresholds may be used to determine the innovation parameter. If a difference between the actual glucose measurement and the predicted measurement is above (or below) a threshold, the value of the innovation parameter may be rounded to another value). The cap of 20g is interpreted as the threshold and the set point for when the value exceeds the threshold. See Regarding Claim 1 for the teachings of the module. Preventing the risk of overdose is associated with safety. The difference between predicted and estimated glucose can be indicative of the size of the unannounced meal. Additionally, Claim 4 is interpreted as a contingent limitation, which indicates the broadest reasonable interpretation requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04).
Regarding Claim 7, El Fathi et al. teach the amount of insulin calculated at each calculating step comprises a residual component calculated by the compensation module according to a residual part based on at least one previous estimated size of a previous unannounced meal (Paragraph 0106: The database is configured to store, for the user, a consumed meal information; The consumed meal information may include one or more of: a composition of the meal, a weight of the meal); and a predetermined ingestion profile relative and personalized to the user (Paragraph 0103: the set of user-specific parameter includes one or more of: patient age, patient weight, endogenous glucose production, noninsulin-dependent glucose flux, activation rate for insulin remote action, patient insulin sensitivity, insulin absorption rate, insulin elimination rate, time-to-maximum of CHO absorption, insulin distribution volume, patient daily total dose, patient basal insulin, patient carbohydrate ratios, patient diet and glucose distribution volume; Paragraph 0143: model parameters based on specific characteristics of the patient, e.g. the set of user-specific parameters; Paragraph 0190: The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor, and the remaining insulin-on-board (IOB). The teachings of utilization of the prior meal info and the user info in the calculation are interpreted and teaching the residual component/part involved in the calculation. The residual part is interpreted as synonymous with the residual component.
Regarding Claim 8, El Fathi et al. teach the amount of insulin calculated comprises a meal component calculated by the compensation module according to a predetermined meal ratio and the estimated size of the unannounced meal (Paragraph 0103: patient insulin sensitivity (e.g. insulin sensitivity of glucose transport, insulin sensitivity of glucose disposal, insulin sensitivity of suppression of EGP), insulin absorption rate, insulin elimination rate, time-to-maximum of CHO absorption; Paragraph 0106: The consumed meal information may include one or more of: a composition of the meal, a weight of the meal, a composition of the meal, a type of the meal, an amount of proteins in the meal, a fiber amount in the meal, a carbohydrate amount in the meal, or an estimation thereof; Paragraph 0190: The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor, and the remaining insulin-on-board (IOB)).
Regarding Claim 9, El Fathi et al. teach wherein the amount of insulin calculated comprises a net IOB component calculated by the compensation module according to a net insulin-on-board of the user (Paragraph 0190: The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor, and the remaining insulin-on-board (IOB)).
Regarding Claim 10, El Fathi et al. teach the value of the net IOB component is equal to zero if the net insulin-on-board is negative or null. Claim 10 is interpreted as a contingent limitation, which indicates the broadest reasonable interpretation requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04).
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over El Fathi et al. (US 20220280720, IDS 13 September 2023), as applied to claims 1-4 and 7-12 in the 35 USC 102 rejection above, in view of Dassau et al. (US 20220257857 A1). Italicized text from reference art.
Applicable claims include:
Claim 1. A system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user, said system comprising (Claim 1.i) a detection module, said detection module being adapted to implement a detection step consisting of detecting an unannounced meal at an initial time-point; (Claim 1.ii) an estimation module, said estimation module being adapted to implement an estimation step consisting of estimating the size of the unannounced meal; (Claim 1.iii) a compensation module, said compensation module being adapted to implement a calculation step consisting of calculating an amount of insulin at least based on the estimated size of the unannounced meal, (Claim 1.iv) the estimation module and the compensation module being adapted to repeat the estimation step and the calculation step for a determined number of times with a determined time periodicity.
Claim 2. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, the system further comprising a condition module, said condition module being adapted to verify whether at least one condition is met, the calculation step being implemented by the compensation module if the at least one condition is met.
Claim 3. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 2, wherein one of the at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value.
Claim 4. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1 wherein the system further comprises an estimation safety module, said estimation safety module being adapted to determine whether the estimated size of the unannounced meal exceeds a meal estimation threshold value and set the estimated size at a value equal to the meal estimation threshold value if the estimated size of the unannounced meal exceeds the meal estimation threshold value.
Claim 5. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1 wherein the determined number of times is comprised between 2 and 10, preferably between 3 and 5, even more preferably equal to 4.
Claim 6. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1 wherein the determined time periodicity is comprised between 1 and 15 minutes, preferably between 1 and 10 minutes, even more preferably equal to 5 minutes.
Claim 7. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, wherein the amount of insulin calculated at each calculating step comprises a residual component, the residual component being calculated by the compensation module according to a residual part based on: at least one previous estimated size of a previous unannounced meal; and a predetermined ingestion profile relative and personalized to the user.
Claim 8. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, wherein the amount of insulin calculated comprises a meal component, the meal component being calculated by the compensation module according to a predetermined meal ratio and the estimated size of the unannounced meal.
Claim 9. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 1, wherein the amount of insulin calculated comprises a net IOB component, the net IOB component being calculated by the compensation module according to a net insulin-on-board of the user.
Claim 10. The system for estimating an amount of insulin needed to compensate for an unannounced meal ingested by a user according to claim 9 wherein the value of the net IOB component is equal to zero if the net insulin-on-board is negative or null.
Claim 11. A method for calculating an amount of insulin needed to compensate for an unannounced meal ingested by a user implemented by a system according to claim 1, the method comprising: the detection module detects an unannounced meal at an initial time-point; the estimation module implements the estimation step; the compensation module implements the calculation step; the estimation and the calculation step being repeated for a determined number of times with a determined time periodicity.
Claim 12. A computer program for estimating an amount of insulin needed to compensate for 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 11.
Regarding Claims 1, 11, and 12, El Fathi et al. teach (Claim 1.i) a detection module adapted to detecting an unannounced meal at an initial time-point (Paragraph 0013: identify unannounced meals; Paragraph 0042: the glucose change is indicative of an unknown meal, the unknown meal not having been logged by the subject; Paragraph 0101: The control procedure includes a meal detection procedure). El Fathi et al. teach (Claim 1.ii) an estimation module adapted to estimating the size of the unannounced meal (Paragraph 0027: determining an unknown meal amount; Paragraph 0032: the method further comprises estimating a meal size and a time of consumption of the meal). El Fathi et al. teach (Claim 1.iii) a compensation module adapted to calculating an amount of insulin at least based on the estimated size of the unannounced meal (Paragraph 0026: determining an insulin bolus of the unknown meal not having been logged by the given user; Paragraph 0027: prior to said determining the insulin bolus: determining, based on the innovation parameter and the innovation covariance parameter, an unknown meal amount; Paragraph 0033: determining the medication bolus is based, at least in part, on at least one of: the estimated meal size and the estimated time of consumption of the meal). El Fathi et al. teach (Claim 1.iv) the estimation module and the compensation module adapted to repeat the estimation step and the calculation step for a number of times with a time periodicity (Paragraph 0126: the equations are executed recursively; Paragraph 0152: Every M epochs, the state-space modeling procedure estimates the set of user parameters; Paragraph 0158: the state estimates at every iteration). Additionally, El Fathi et al. teach the methods are conducted by a generic computing device, which inherently contains code, memory, including non-transitory computer readable medium, to perform the recited function (Paragraph 0030: there is provided a computer-implemented method for detecting meals consumed by a patient, the method being executed by a processor; Paragraph 0084: Software modules, or simply modules which are implied to be software, may be represented herein as any combination of flowchart elements or other elements indicating performance of process steps and/or textual description. Such modules may be executed by hardware that is expressly or implicitly shown). This is interpreted as encompassing the modules recited by the claims (see 112(f) claim interpretation above). Claim 11 recites the limitations of claim 1 directed to a method. Claim 12 recites the limitations of claim 11 directed to a program executed by a processor.
Regarding Claim 2, El Fathi et al. teach a condition module adapted to verify whether at least one condition is met; and the calculation step being implemented by the compensation module if the at least one condition is met (Paragraph 0126: it is a set of equations implementing a predictor-corrector type estimator to minimize an estimated covariance when conditions are respected; Paragraph 0054: the method further comprises determining that a meal has been consumed in response to the determined probability breaching a threshold). In addition to El Fathi et al. describing a condition that must be met prior to the calculating, having to pass a threshold prior to the calculation is also interpreted as verifying whether a condition is met. The modules are interpreted as generic computing devise (see 112(f) claim interpretation), which are taught by El Fathi et al. (See regarding claim 1).
Regarding Claim 3, El Fathi et al. teach one of the at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value (Paragraph 0189: if m is an estimation of the remaining non-digested meal in the new patient state, the patient safety m may be capped to a give n value such as 20 g. The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor and the remaining insulin-on-board (IOB)). The system calculates a dose to be administered only if the IOB will not exceed a maximum value.
Regarding Claim 4, El Fathi et al. teach an estimation safety module adapted to determine whether the estimated size of the unannounced meal exceeds a meal estimation threshold value set the estimated size at a value equal to the meal estimation threshold value if the estimated size of the unannounced meal exceeds the meal estimation threshold value (Paragraph 0220: Since the remaining meal size m is capped to a small CHO value (20 g in this case), the risk of overdosing insulin is minimized; Paragraph 0140: It will be appreciated that the innovation parameter indicative of the mismatch between the actual glucose measurement, and the predicted measurement may be determined in various ways, and corrective factors or thresholds may be used to determine the innovation parameter. If a difference between the actual glucose measurement and the predicted measurement is above (or below) a threshold, the value of the innovation parameter may be rounded to another value). The cap of 20g is interpreted as the threshold and the set point for when the value exceeds the threshold. See Regarding Claim 1 for the teachings of the module. Preventing the risk of overdose is associated with safety. The difference between predicted and estimated glucose can be indicative of the size of the unannounced meal. Additionally, Claim 4 is interpreted as a contingent limitation, which indicates the broadest reasonable interpretation requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04).
Regarding Claim 7, El Fathi et al. teach the amount of insulin calculated at each calculating step comprises a residual component calculated by the compensation module according to a residual part based on at least one previous estimated size of a previous unannounced meal (Paragraph 0106: The database is configured to store, for the user, a consumed meal information; The consumed meal information may include one or more of: a composition of the meal, a weight of the meal); and a predetermined ingestion profile relative and personalized to the user (Paragraph 0103: the set of user-specific parameter includes one or more of: patient age, patient weight, endogenous glucose production, noninsulin-dependent glucose flux, activation rate for insulin remote action, patient insulin sensitivity, insulin absorption rate, insulin elimination rate, time-to-maximum of CHO absorption, insulin distribution volume, patient daily total dose, patient basal insulin, patient carbohydrate ratios, patient diet and glucose distribution volume; Paragraph 0143: model parameters based on specific characteristics of the patient, e.g. the set of user-specific parameters; Paragraph 0190: The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor, and the remaining insulin-on-board (IOB). The teachings of utilization of the prior meal info and the user info in the calculation are interpreted and teaching the residual component/part involved in the calculation. The residual part is interpreted as synonymous with the residual component.
Regarding Claim 8, El Fathi et al. teach the amount of insulin calculated comprises a meal component calculated by the compensation module according to a predetermined meal ratio and the estimated size of the unannounced meal (Paragraph 0103: patient insulin sensitivity (e.g. insulin sensitivity of glucose transport, insulin sensitivity of glucose disposal, insulin sensitivity of suppression of EGP), insulin absorption rate, insulin elimination rate, time-to-maximum of CHO absorption; Paragraph 0106: The consumed meal information may include one or more of: a composition of the meal, a weight of the meal, a composition of the meal, a type of the meal, an amount of proteins in the meal, a fiber amount in the meal, a carbohydrate amount in the meal, or an estimation thereof; Paragraph 0190: The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor, and the remaining insulin-on-board (IOB)).
Regarding Claim 9, El Fathi et al. teach wherein the amount of insulin calculated comprises a net IOB component calculated by the compensation module according to a net insulin-on-board of the user (Paragraph 0190: The insulin bolusing determination procedure determines an insulin bolus, where the insulin bolus is proportional to the remaining meal, patient carbohydrate ratio, glucose level, glucose target, patient-specific correction factor, and the remaining insulin-on-board (IOB)).
Regarding Claim 10, El Fathi et al. teach the value of the net IOB component is equal to zero if the net insulin-on-board is negative or null. Claim 10 is interpreted as a contingent limitation, which indicates the broadest reasonable interpretation requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04).
El Fathi et al. does not teach a specific quantity of time or number of iterations indicated in Claims 5 and 6.
Regarding Claim 2, Dassau et al. teach verify whether at least one condition is met; and the calculation step being implemented by the compensation module if the at least one condition is met (Paragraph 0064: The quantity umax,k IOB indicates how much insulin above the basal insulin rate u*k can be administered safely (from a clinical perspective) at the current time step k; see equations of Paragraph 0062).
Regarding Claim 3, Dassau et al. teach one of the at least one condition is: a variable IOB(t), representative of the time variation of the user's quantity of insulin on board, is lower than a predetermined value and/or a total amount of insulin calculated during a predetermined past time period is lower than a predetermined value (Paragraph 0064: The quantity umax,k IOB indicates how much insulin above the basal insulin rate u*k can be administered safely (from a clinical perspective) at the current time step k; Paragraph 0065: Widely used umax,k include mechanical constraints such as the maximum infusion rate of the pump, physiological constraints such as the insulin-on-board constraint, and safety constraints such as limitations on insulin infusion post-exercise).
Regarding Claim 5, Dassau et al. teach the determined number of times is comprised between 2 and 10, preferably between 3 and 5, even more preferably equal to 4 (Paragraph 0113: The system may select a predictive horizon of Ny=9 (45 min), and control horizon Nu=5 (25 min) for the ZMPC). The horizons correspond to the number of times the information is sampled within a given time period (every 5min in this case).
Regarding Claim 6, Dassau et al. teach the determined time periodicity is comprised between 1 and 15 minutes, preferably between 1 and 10 minutes, even more preferably equal to 5 minutes (Paragraph 0095: The model has a sampling time τ=5 min).
Regarding Claim 7, Dassau et al. teach the amount of insulin calculated at each calculating step comprises a residual component calculated by the compensation module according to a residual part based on at least one previous estimated size of a previous unannounced meal (Paragraph 0053: the event-based controller remains on for 18 h of 41 h in closed-loop with unannounced meals; Paragraph 0119: The clinical scenario used to test the proposed controller is presented in FIG. 2. Five meals in total are consumed within 41 simulated hours of closed-loop control; also see Figure 2); and a predetermined ingestion profile relative and personalized to the user (Paragraph 0095: personalized with respect to each subject; Paragraph 0106: a patient-specific clinical parameter).
Regarding Claim 8, Dassau et al. teach the amount of insulin calculated comprises a meal component calculated by the compensation module according to a predetermined meal ratio and the estimated size of the unannounced meal (Paragraph 0052: good glycemic regulation performance in spite of large announced and unannounced meals; Paragraph 0095: personalized with respect to each subject with T1DM via the insulin to carbohydrate ratio, total daily insulin amount, and basal insulin profile).
Regarding Claim 9, Dassau et al. teach wherein the amount of insulin calculated comprises a net IOB component calculated by the compensation module according to a net insulin-on-board of the user (Paragraph 0062: An additional constraint on the insulin output is the insulin-on-board (IOB) upper bound).
Regarding Claim 10, Dassau et al. teach et al. teach the value of the net IOB component is equal to zero if the net insulin-on-board is negative or null (Paragraph 0062: An additional constraint on the insulin output is the insulin-on-board (IOB) upper bound. The IOB accounts for the administered insulin history and computes the remaining active insulin in the body based on clearance rates in the human endocrine system. In addition to a positivity constraint (the drug infusion rate cannot be negative), the control action must also satisfy a time-varying upper bound). The upper bound constraints indicates the IOB cannot be negative. Therefore it would be obvious to set it equal to zero. Also see figure 12B and 13D for setting the minimum IOB vale equal to 0.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine Dassau et al. with El Fathi et al. Dassau et al. teach their systems/methods have increased efficiency, applicability, and safety for predicting insulin changes related meals (Paragraph 0052: The proposed method is tested with rigorous hardware-in-the-loop simulation studies that constitute a pre-clinical assessment of the algorithm's safety and efficacy to be further evaluated in a clinical study setting. Accordingly, the benefits of this solution include: (1) it can be integrated with any variant of the MPC or other control algorithms for decision-making in the AP; (2) it significantly reduces processor runtime and energy consumption with good glycemic regulation performance in spite of large announced and unannounced meals). Furthermore, one of ordinary skill in the art would predict that the methods/systems taught by Dassau et al. with El Fathi et al. could be readily combined with a reasonable expectation of success because both are within the same technical field – estimating insulin needs related to blood sugar and unannounced meals. Accordingly, Claims 1-12 taken as a whole would have been prima facie obvious before the effective filing date and are rejected under 35 U.S.C. 103.
Double Patenting
No double patenting is identified.
Conclusion
No Claims are allowed.
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/B.H.E./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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