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 .
Information Disclosure Statement
The Information Disclosure Statements filed 01/26/2023, 11/16/2023, 06/10/2025, and 07/31/2025 have been considered by the Examiner.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-15) and Species A (Claim 17) in the reply filed on 07/01/2026 is acknowledged. The traversal of the restriction between Groups I and II is on the ground(s) that the claims across alleged Groups I and II are directed to closely related glucose monitoring and analysis techniques that rely on the processing of obtained glucose measurements, in conjunction with user contextual information, to generate predicted glucose measurements. The Applicant further argues that both alleged Groups I and II are grounded in a common technical framework that involves, for example: "obtaining" glucose measurements; "detecting" a user "event or condition" such as a "bout of physical activity"; "predicting an impact" of the event or condition on the glucose of the user "by generating, based on the glucose measurements, one or more predicted glucose measurements"; and "causing the one or more predicted glucose measurements to be displayed". The Applicant argues that the claims in each alleged Group also exhibit overlapping scope and further argues that the "bout of physical activity" recited in alleged Group I represents a particular type of user condition that affects glucose levels, which falls within the broader category of "event or condition of the user that affects glucose levels" recited in alleged Group II. The Applicant further argues that the distinctions identified by the Restriction Requirement reflect differences in how the "user condition" is characterized, rather than a separation into mutually exclusive subject matter. The Applicant further argues that accordingly, at least some embodiments encompassed by the claims in each alleged Group would reasonably be understood to operate within the same end-to-end workflow such that the claimed subject matter shares a unified technical approach rather than requiring separate treatment. The Applicant further argues that both alleged Groups I and II relate to glucose monitoring, user contextual information correlation, and glucose measurement prediction thus suggesting that the underlying technologies are substantially similar, and the claims would reasonably be expected to involve overlapping search strategies, reducing any incremental burden. The Applicant further argues that while the Restriction Requirement references different classifications, the relevant inquiry is whether materially different prior art searches would be required. The Applicant also argues that the claimed subject matter appears to reside within closely related areas of glucose monitoring and data analysis, such that a unified search would be practical.
This is not found persuasive. The Examiner asserts that the Applicant’s characterizations of the similarity and the differences are an oversimplification of the groups and attempts to drown out the key differences between Groups I and II that show distinctness. The Examiner maintains that the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect. For instance, Invention I requires a glucose sensor being inserted at an insertion site of the user and requires detecting a bout of physical activity performed by the user. These requirements of Invention I are not found in Invention II. For instance, while Invention II does require obtaining glucose measurements from a sensor, there is no requirement in Invention II that the sensor is being inserted at an insertion site of the user. Instead, Invention II could involve a non-invasive glucose sensor that would therefore have a materially different design, mode of operation, and function. Additionally, while Invention II does require detecting an event or condition of the user, Invention II does not require detecting a bout of physical activity performed by the user. While a bout of physical activity could be considered a detected event, Invention II also recites the option of detecting other conditions that affect glucose levels of the user. Conditions affecting glucose levels, such as food/drink consumption, sleeping, feeling stressed, taking medication, feeling sick, dehydration, caffeine/alcohol consumption, etc., do not overlap with the scope of Invention I which is solely detecting a bout of physical activity. Additionally, there are numerous events outside of physical activity that do not overlap with the scope of Invention I. If the method of Invention II detects a condition or event outside of a bout of physical activity, the inventions will further have a different design, mode of operation, function, or effect. For instance, while a sensor such as an inertial measurement unit (e.g., accelerometer, gyroscope) would potentially be used for measuring physical activity, another sensor would be required for detecting a different condition of the user such as stress levels, which would require a sensor that monitors heart rate variability or electrodermal activity, for example. For such reasons, the Examiner further maintains that the inventions do require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Therefore, the restriction requirement between Inventions I and II are maintained.
Additionally, the traversal of the restriction between species of claims 17-20 is on the ground(s) that these recitations represent different instances of a common category of "event or condition of the user that affects glucose levels of the user," as expressly recited in Claim 16, rather than distinct ideas requiring separate examination. The Applicant further argues that each of Claims 17-20 applies the same claimed framework of "detecting an event or condition of the user that affects glucose levels of the user" and "predicting an impact of the event or condition on glucose of the user by generating, based on the glucose measurements, one or more predicted glucose measurements." The Applicant further argues that the differences among these claims relate to the particular type of "event or condition" being detected, not to any materially different processing, mode of operation, or output. The Applicant further argues that the alleged species reflect variations in the characterization of user contextual inputs within a shared technical approach, and the Restriction Requirement does not establish that examination of these claims together would impose a serious search or examination burden.
This is not found persuasive. The Examiner maintains that the species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species of different types of events or conditions of the user that can be detected by a diabetes management monitoring system and that affect glucose levels of the user. The Examiner disagrees with the Applicant’s characterization of the distinct species. The Examiner asserts that detecting the food or drink consumed by the user would be materially different than detecting whether the user is sleeping or whether the user has taken their medicine. Such different detected events/conditions would necessarily require different sensing and processing steps, and would thus require a serious search burden. For instance, the species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries). Therefore, the species restriction is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07/01/2026.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 8 objected to because of the following informalities:
Line 4: “number of steps for at least” should be changed to “number of steps per minute for at least”.
Claim 12 objected to because of the following informalities:
Lines 1-2: “is further to identify” should be changed to “is further configured to identify”.
Claim 13 objected to because of the following informalities:
Lines 1-2: “is further to generate” should be changed to “is further configured to generate”.
Claim 14 objected to because of the following informalities:
Lines 1-2: “is further to generate” should be changed to “is further configured to generate”.
Claim 15 objected to because of the following informalities:
Lines 1-2: “is further to detect” should be changed to “is further configured to detect”.
Claim 15 objected to because of the following informalities:
Line 4: “number of steps for at least” should be changed to “number of steps per minute for at least”.
Appropriate correction is required.
Claim Interpretation
The term “Metabolic Equivalents value” used in claim 10 are described in the Applicant’s specification as an estimate of the amount of energy used relative to the user sitting at rest, and one MET is the amount of oxygen consumed by the user while sitting at rest (Par. [0064]).
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 limitations are:
“an activity detection module … to detect a bout of physical activity performed by the user” in claim 11.
“a glucose prediction module … to predict an impact of the physical activity on glucose of the user by generating, based on the glucose measurements, one or more predicted glucose measurements that the user would have had if, during a time the user was performing the bout of physical activity, the user had not performed the bout of physical activity” in claim 11.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181(II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations of the specification:
Fig. 3, # 302 – event detection module; Par. [0050] – Physical activity data can be received from various sources, such as wearable glucose monitoring device 104, an activity tracking application running on computing device 106, an activity or fitness tracker worn by the user 102, and so forth; Par. [0059] – In one or more implementations, the event detection module 302 identifies a bout of physical activity based on a number of steps taken; Par. [0064-0065] – METs; Par. [0067] – heart rate monitor
Fig. 3, # 308; e.g., Par. [0072-0074] – In one or more implementations, the glucose measurement prediction module 308 includes a machine learning system that generates the predicted glucose measurements; Par. [0080] – the glucose measurement prediction module 308 can use physiological (pharmo-kinetics) or phenomenological models. E.g., glucose uptake can be modeled using ordinary differential equations that have parameters such as glucose uptake and exercise intensity.
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 8-10 and 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.
Claim 8 recites the limitation “a bout of physical activity” in line 2, whereas a bout of physical activity was already introduced in a claim that claim 8 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different bout of physical activity. Consider changing to “the bout of physical activity”.
Claim 9 recites the limitation “a bout of physical activity” in line 2, whereas a bout of physical activity was already introduced in a claim that claim 9 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different bout of physical activity. Consider changing to “the bout of physical activity”.
Claim 10 recites the limitation “a bout of physical activity” in line 2, whereas a bout of physical activity was already introduced in a claim that claim 10 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different bout of physical activity. Consider changing to “the bout of physical activity”.
Claim 15 recites the limitation “a bout of physical activity” in line 2, whereas a bout of physical activity was already introduced in a claim that claim 15 depends from (claim 11). It is unclear whether the Applicant intended to claim the same or a different bout of physical activity. Consider changing to “the bout of physical activity”.
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 an abstract idea (mental process of detecting a bout of physical activity and predicting an impact of the physical activity on glucose of the user) without significantly more.
Step 1
Independent claims 1 and 11 are directed to a method and a device/apparatus, and thus meet the requirements for step 1.
Step 2A, Prong 1
Regarding claims 1 and 11, the following steps recite an abstract idea:
“detecting a bout of physical activity performed by the user” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally detect whether a user performed a bout of physical activity by observing, evaluating, and making judgements of a user’s movements.
“predicting an impact of the physical activity on glucose of the user by generating, based on the glucose measurements, one or more predicted glucose measurements that the user would have had if, during a time the user was performing the bout of physical activity, the user had not performed the bout of physical activity” is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(III), the mental process grouping includes observations, evaluation, judgements, and opinions. In this case, a human could mentally predict (i.e., make a judgement) about the impact of the physical activity on glucose of the user. For instance, a human could make a prediction/judgement about a user’s glucose levels, based on prior glucose measurements, if the user had not performed the bout of physical activity. For instance, a human can make predictions about where a user’s glucose levels would have been (i.e., higher or lower) had the user not performed the bout of physical activity.
Step 2A, Prong 2
Regarding claims 1 and 11, the claims do not include any additional elements that integrate the abstract idea into a practical application. The following elements do not add any meaningful limitation to the abstract idea:
Obtaining, from a glucose sensor of the continuous glucose level monitoring system, glucose measurements measured for a user, the glucose sensor being inserted at an insertion site of the user – A glucose sensor is recited at a high level of generality. Par. [0043] of Applicant’s specification explains that the sensor 202 may be configured as or include a glucose sensor configured to detect analytes in blood or interstitial fluid that are indicative of diabetes management using one or more measurement techniques. The glucose sensor’s involvement is insignificant pre-solution activity in that the sensor is merely used to gather and collect data [MPEP 2106.05(g)]
Causing the one or more predicted glucose measurements to be displayed – amounts to merely outputting data, which is insignificant extra-solution activity [MPEP 2106.05(g)]
Biological data detection module, activity detection module, glucose prediction module, and user interface module – These modules are recited with a high level of generality as all being apart of a glucose prediction system 120 (see Fig. 3 and Par. [0048] of Applicant’s Specification). Fig. 8 and Par. [0116] of Applicant’s Specification explains that a computing device 802 is representative of one or more computing systems and/or devices that may implement the glucose prediction system. The involvement of the biological data detection module, activity detection module, glucose prediction module, and user interface module are considered insignificant extra-solution activity in that they amount to generic computer implementation of the abstract idea [MPEP 2106.04(a)(2)(III)(C)].
Therefore, the claims are directed to an abstract idea without a practical application.
Step 2B
The additional elements of claims 1 and 11, when considered either individually or in an ordered combination, are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the biological data detection module, activity detection module, glucose prediction module, and user interface module, along with their associated functions and components, are recited with a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements that were considered insignificant extra-solution activity have been re-analyzed and do not amount to anything more than what is well understood, routine, and conventional. Also, simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not indicative of an inventive concept [MPEP 2106.05(d)].
Obtaining, from a glucose sensor of the continuous glucose level monitoring system, glucose measurements measured for a user, the glucose sensor being inserted at an insertion site of the user – Matsumoto (US 2015/0162146) explains that in the conventional biological information measurement device, a blood glucose level sensor which is an example of a biological information measurement sensor is mounted into the sensor mounting unit, the control unit wakes up from an idle state, and the measurement unit can measure a blood glucose level (Par. [0003]). Also, MPEP 2106.05(d)(II)(“i. Receiving or transmitting data over a network).
Causing the one or more predicted glucose measurements to be displayed – Zamanakos, et al. (US 2016/0098848 – cited on IDS) explains that the host has a continuous glucose monitoring system, such as the DexCom G4® Platinum continuous glucose monitoring system, commercially available from DexCom, Inc., which provides measurements of the host's glucose levels on a display device, such as the DexCom G4® Platinum Receiver, also commercially available from DexCom, Inc. (Par. [0150]
Biological data detection module, activity detection module, glucose prediction module, and user interface module – These modules are all considered computer process components of a glucose prediction system that is operated on a computer (see Figs. 3 and 8, as well as Pars. [0048] and [0116] of Applicant’s Specification). Budiman, et al. (US 2010/0317952) explains that insulin therapy is derived by the system based on the model's ability to predict glucose levels for various inputs, and that other conventional modeling techniques may be additionally or alternatively used to predict glucose levels, including for example, but not limited to, building models from first principles (Par. [0060]).
Therefore, the claims are directed to an abstract idea without a practical application and without significantly more.
Dependent claims
Regarding dependent claims 2, 4, 6-10, 12, and 14-15, the limitations only further define the abstract idea (i.e., mental process).
Regarding dependent claims 3, 5, and 13, the limitations only further define the abstract idea (i.e., mental process/mathematical process).
Therefore, claims 1-15 are unpatentable under 35 U.S.C. 101.
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 1-7 and 11-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shima, et al. (US 2022/0093234).
Regarding claim 1, Shima teaches a method implemented in a continuous glucose level monitoring system (Title; Par. [0009] – the method further comprises monitoring the blood glucose level of the subject at least in part by using a continuous glucose monitoring device), the method comprising:
(Fig. 4A, # 406-0 and 406-1) obtaining, from a glucose sensor of the continuous glucose level monitoring system, glucose measurements measured for a user (Par. [0101] – such a display can include any of: a visualization (e.g., graph) comparing BG of a previous day of the program to one or more other days of the program 406-0 and/or a visualization (e.g., graph) comparing BG of a previous day to a counterfactual case 406-1), (Fig. 12, # 1216) the glucose sensor being inserted at an insertion site of the user (Par. [0188] – a first type sensor 1216 can be a continuous glucose monitor (CGM), which can track a glucose level of a subject);
(Fig. 3A, # 302; Fig. 12, # 1218) detecting a bout of physical activity performed by the user (Par. [0067] – activity monitors, such as heart rate (HR) monitors or other activity monitors; Par. [0093] - A method 300 can include monitoring various activities of a subject 302. Monitored activities can include, but are not limited to: food events, physical activities, doses of medication, and water/beverage consumption; Par. [0188] – A second type sensor 1218 can be heart rate monitor (HRM) which can track a subject's heart rate.);
(Fig. 4C, # 416-0, 418-0, 418-1; Fig. 4E, # 422; Figs. 5D-E, # 540-2) predicting an impact of the physical activity on glucose of the user by generating, based on the glucose measurements, one or more predicted glucose measurements that the user would have had if, during a time the user was performing the bout of physical activity, the user had not performed the bout of physical activity (Par. [0104] – The display shows, generally from top to bottom, the description of an activity (i.e., walking), followed by a comparison of the health effect of the activity as a counterfactual case (walking after a meal) with that of a program day (the meal without walking). In the embodiment shown, the BG response of the day is shown as a graph 416 over a time period showing an undesirable health response (e.g., increase in BG) 416-0. Overlaid on the graph is the projected BG response for one or more (in this case two) counterfactual cases 418-0/1 (e.g., with a 25 minute walk, with a 50 minute walk); Par. [0106]; Pars. [0116] and [0118]); and
(Figs. 4C and 5E) causing the one or more predicted glucose measurements to be displayed (Pars. [0104] and [0118]).
Therefore, claim 1 is unpatentable over Shima, et al.
Regarding claim 2, Shima teaches the method of claim 1, further comprising (Figs. 5D-E) identifying a subset of the glucose measurements that were measured immediately preceding the bout of physical activity, and the generating including generating the one or more predicted glucose measurements based on the subset of glucose measurements (Pars. [0115] and [0118]).
Therefore, claim 2 is unpatentable over Shima, et al.
Regarding claim 3, Shima teaches the method of claim 1, wherein (Fig. 2A, # 206; Fig. 5C, # 526; Figs. 5D-E) the generating includes generating the one or more predicted glucose measurements using a machine learning system trained to predict glucose measurements for the user based on previous glucose measurements of the user (Par. [0084] – Such an action can include generating a glucose level response for a subject in response to the food. A response can be based on any suitable model, including but not limited to: models based on machine learning, models based on cohort responses, preexisting models based on a demographic match the subject, and/or previous responses of the subject to same or similar foods.; Par. [0113] – Such an action can include applying the food and activity to a model which simulates a BG response. A model can take the form of any of those described herein, including preexisting models or models created by machine learning.).
Therefore, claim 3 is unpatentable over Shima, et al.
Regarding claim 4, Shima teaches the method of claim 1, wherein (Fig. 2A) the generating includes generating the one or more predicted glucose measurements based on one or more of physiological parameters of the user, demographic information of the user, or clinical information of the user (Par. [0084] – Such an action can include generating a glucose level response for a subject in response to the food. A response can be based on any suitable model, including but not limited to: models based on machine learning, models based on cohort responses, preexisting models based on a demographic match the subject, and/or previous responses of the subject to same or similar foods.).
Therefore, claim 4 is unpatentable over Shima, et al.
Regarding claim 5, Shima teaches the method of claim 1, wherein (Fig. 2A) the generating includes generating the one or more predicted glucose measurements using a physiological or phenomenological model (Par. [0084]; Par. [0113]).
Therefore, claim 5 is unpatentable over Shima, et al.
Regarding claim 6, Shima teaches the method of claim 1, wherein (Figs. 4C and 5E) the generating includes generating predicted glucose measurements for a duration of the bout of physical activity (Par. [0104]; Par. [0118]).
Therefore, claim 6 is unpatentable over Shima, et al.
Regarding claim 7, Shima teaches the method of claim 6, wherein (Figs. 4C and 5E) the generating further includes generating predicted glucose measurements for a duration of time after the bout of physical activity (Par. [0104]; Par. [0118]).
Therefore, claim 7 is unpatentable over Shima, et al.
Regarding claim 11, Shima teaches (Fig. 12, # 1216) a device including a diabetes management monitoring system (Title; Abstract; Par. [0009]; Par. [0188] – a first type sensor 1216 can be a continuous glucose monitor (CGM), the device comprising:
(Fig. 4A, # 406-0 and 406-1; Fig. 12, # 1200, 1202, 1204) a biological data detection module, implemented at least in part in hardware, to obtain, from a sensor of the diabetes management monitoring system, glucose measurements measured for a user (Par. [0101] – such a display can include any of: a visualization (e.g., graph) comparing BG of a previous day of the program to one or more other days of the program 406-0 and/or a visualization (e.g., graph) comparing BG of a previous day to a counterfactual case 406-1; Par. [0183-0184] – Servers (1202/1204) can execute various methods as described herein and equivalents. Such functions can acquire data from data sources (1216, 1218, 1220) as well as other data residing on data storage 1222.; Examiner notes that such system and components shown in Fig. 12 teaches the biological data detection module);
(Fig. 3A, # 302; Fig. 12, # 1200, 1202, 1204, 1218) an activity detection module, implemented at least in part in hardware, to detect a bout of physical activity performed by the user (Par. [0067] – activity monitors, such as heart rate (HR) monitors or other activity monitors; Par. [0093] - A method 300 can include monitoring various activities of a subject 302. Monitored activities can include, but are not limited to: food events, physical activities, doses of medication, and water/beverage consumption; Par. [0183-0184] – Servers (1202/1204) can execute various methods as described herein and equivalents. Such functions can acquire data from data sources (1216, 1218, 1220) as well as other data residing on data storage 1222.; Par. [0188] – A second type sensor 1218 can be heart rate monitor (HRM) which can track a subject's heart rate.; Examiner notes that such system and components shown in Fig. 12 teaches the activity detection module);
(Fig. 4C, # 416-0, 418-0, 418-1; Fig. 4E, # 422; Figs. 5D-E, # 540-2) a glucose prediction module, implemented at least in part in hardware, to predict an impact of the physical activity on glucose of the user by generating, based on the glucose measurements, one or more predicted glucose measurements that the user would have had if, during a time the user was performing the bout of physical activity, the user had not performed the bout of physical activity (Par. [0104] – The display shows, generally from top to bottom, the description of an activity (i.e., walking), followed by a comparison of the health effect of the activity as a counterfactual case (walking after a meal) with that of a program day (the meal without walking). In the embodiment shown, the BG response of the day is shown as a graph 416 over a time period showing an undesirable health response (e.g., increase in BG) 416-0. Overlaid on the graph is the projected BG response for one or more (in this case two) counterfactual cases 418-0/1 (e.g., with a 25 minute walk, with a 50 minute walk); Par. [0106]; Pars. [0116] and [0118]; Par. [0183-0184] – Servers (1202/1204) can execute various methods as described herein and equivalents. Such functions can acquire data from data sources (1216, 1218, 1220) as well as other data residing on data storage 1222.; Examiner notes that such system and components shown in Fig. 12 teaches the glucose prediction module); and
(Figs. 4C and 5E; Figs. 12-13, # 1230 and 1300 – subject device) a user interface module, implemented at least in part in hardware, to cause the one or more predicted glucose measurements to be displayed (Pars. [0104], [0118]; Par. [0183-0184] – Servers (1202/1204) can execute various methods as described herein and equivalents. Such functions can acquire data from data sources (1216, 1218, 1220) as well as other data residing on data storage 1222.; Pars. [0189-0191] – Various application functions and methods as described herein are executable on a subject device having a display screen.; Examiner notes that such system and components shown in Fig. 12 teaches the user interface module).
Therefore, claim 11 is unpatentable over Shima, et al.
Regarding claim 12, Shima teaches the device of claim 11, wherein (Figs. 5D-E) the glucose prediction module is further to identify a subset of the glucose measurements that were measured immediately preceding the bout of physical activity and generate the one or more predicted glucose measurements based on the subset of glucose measurements (Pars. [0115] and [0118]).
Therefore, claim 12 is unpatentable over Shima, et al.
Regarding claim 13, Shima teaches the device of claim 11, wherein (Fig. 2A, # 206; Fig. 5C, # 526; Figs. 5D-E) the glucose prediction module is further to generate the one or more predicted glucose measurements using a machine learning system trained to predict glucose measurements for the user based on previous glucose measurements of the user (Par. [0084] – Such an action can include generating a glucose level response for a subject in response to the food. A response can be based on any suitable model, including but not limited to: models based on machine learning, models based on cohort responses, preexisting models based on a demographic match the subject, and/or previous responses of the subject to same or similar foods.; Par. [0113] – Such an action can include applying the food and activity to a model which simulates a BG response. A model can take the form of any of those described herein, including preexisting models or models created by machine learning.).
Therefore, claim 13 is unpatentable over Shima, et al.
Regarding claim 14, Shima teaches the device of claim 11, wherein (Figs. 4C and 5E) the glucose prediction module is further to generate predicted glucose measurements for a duration of the bout of physical activity (Par. [0104]; Par. [0118]).
Therefore, claim 14 is unpatentable over Shima, et al.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shima, et al. (US 2022/0093234) in view of Dervisoglu, et al. (US 2021/0093917).
Regarding claims 8 and 15, Shima teaches the method of claim 1 and the device of claim 11, as indicated hereinabove. Shima does not teach the limitation of instant claim 8 or 15, that is wherein the detecting a bout of physical activity includes detecting, as a bout of physical activity, a duration of time during which the user took at least a threshold number of steps per minute for at least a threshold amount of time without dropping below the threshold number of steps for at least a consecutive number of minutes.
Dervisoglu, directed to analogous art, teaches detecting outdoor walking workouts on a wearable device (Title; Abstract). Dervisoglu also teaches the limitation of instant claim 8, that is wherein (Fig. 3, # 312) the detecting a bout of physical activity includes detecting, as a bout of physical activity, a duration of time during which the user took at least a threshold number of steps per minute for at least a threshold amount of time without dropping below the threshold number of steps for at least a consecutive number of minutes (Par. [0045] – if a step rate exceeds a minimum step rate threshold for at least a bout threshold including minimum bout duration, the bout detector 312 may detect a bout. In various embodiments, a bout requires continuous steps for a defined period that exceeds the bout threshold, but there can be stops in between the steps as long as the stops are temporary. The minimum step rate threshold (e.g., 60 steps per minute) and or minimum bout duration (e.g., 5 minutes) included in the bout threshold by be determined by …. In response to detecting a bout, a pedestrian work model 314 may determine work performed by a user during the walking activity.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Dervisoglu’s method/device of detecting a bout of physical activity into Shima’s method/device, because doing so would be an example of using a known technique to improve similar methods/devices in the same way. One of ordinary skill in the art would have desired implementing Dervisoglu’s method/device of detecting walking into Shima’s method/device because of Shima’s method of proposing a walking activity (see Figs. 4C and 5E) and to better ensure that the glucose predictions are correct as the user will be legitimately meeting a threshold for walking.
Therefore, claims 8 and 15 are unpatentable over Shima, et al. and Dervisoglu, et al.
Regarding claim 9, Shima teaches the method of claim 1, as indicated hereinabove. Shima does not teach the limitation of instant claim 9, that is wherein the detecting a bout of physical activity includes detecting, as a bout of physical activity, a duration of time during which a heart-rate based intensity value of the user exceeded a threshold amount for at least a threshold amount of time without dropping below the threshold amount for at least a consecutive amount of time.
Dervisoglu, directed to analogous art, teaches detecting outdoor walking workouts on a wearable device (Title; Abstract). Dervisoglu also teaches the limitation of instant claim 9, that is wherein (Fig. 6, # 606) the detecting a bout of physical activity includes detecting, as a bout of physical activity, a duration of time during which a heart-rate based intensity value of the user exceeded a threshold amount for at least a threshold amount of time without dropping below the threshold amount for at least a consecutive amount of time (Pars. [0072-0073] – If the calculated user heart rate is consistent with the expected heart rate (i.e., the calculated user heart rate is within a threshold percent difference of the expected heart rate), the walking workout may be maintained. If the calculated user heart rate is inconsistent with the expected heart rate included in the walking activity profile (i.e., the calculated user heart rate is not within a threshold percent difference of the expected heart rate), additional analysis may be performed to confirm the end of the walking workout).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Dervisoglu’s method of detecting a bout of physical activity into Shima’s method, because doing so would be an example of using a known technique to improve similar methods in the same way. One of ordinary skill in the art would have desired implementing Dervisoglu’s method of detecting walking based on heart rate because of Shima’s method of proposing a walking activity (see Figs. 4C and 5E) and Shima’s disclosure of heart rate monitors as activity monitors (see Par. [0067]). One of ordinary skill in the art would have further desired implementing Dervisoglu’s method of detecting walking based on heart rate into Shima’s method to better ensure that the glucose predictions are correct as the user will be legitimately meeting a threshold for walking.
Therefore, claim 9 is unpatentable over Shima, et al. and Dervisoglu, et al.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shima, et al. (US 2022/0093234) in view of Humblet, et al. (US 2021/0068712).
Regarding claim 10, Shima teaches the method of claim 1, as indicated hereinabove. Shima does not explicitly teach the limitation of instant claim 10, that is wherein the detecting a bout of physical activity includes detecting, as a bout of physical activity, a duration of time during which a number of Metabolic Equivalents value of the user exceeded a threshold amount for at least a threshold amount of time without dropping below the threshold amount for at least a consecutive amount of time.
Humblet, directed to analogous art, teaches detecting the end of cycling activities on a wearable device (Title; Abstract). Humblet also teaches the limitation of instant claim 10, that is wherein (Fig. 6, # 608) the detecting a bout of physical activity includes detecting, as a bout of physical activity, a duration of time during which a number of Metabolic Equivalents value of the user exceeded a threshold amount for at least a threshold amount of time without dropping below the threshold amount for at least a consecutive amount of time (Par. [0054] – At step 608, the wearable device may compare the mechanical work rate calculated for a user to a work rate threshold (e.g., 50-100 joules/second, 50-100 Watts, 2.1 to 2.9 metabolic equivalent (METs), and the like)…. To accurately detect all cycling activities including low intensity cycling activities, the work rate threshold may be consistent with a work rate achieved during light exercise (i.e., between 2.1 and 2.9 METs). If the mechanical work rate is below the mechanical work rate threshold, the wearable device may determine the user has stopped cycling and may detect an end of a cycling activity, at step 610.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Humblet’s method of detecting a bout of physical activity into Shima’s method, because doing so would be an example of using a known technique to improve similar methods in the same way. One of ordinary skill in the art would have desired implementing Humblet’s method of detecting physical activity into Shima’s method in order to better ensure that the glucose predictions are correct as the user will be legitimately meeting a threshold for activity. One of ordinary skill in the art would recognize that while being specifically directed to cycling, Humblet also teaches surveying the mechanical work rate for walking (Par. [0054] of Humblet), and so one of ordinary skill in the art would find it obvious that such thresholds involving METs could also be used with the activity of walking, which is the physical activity that Shima is primarily directed to (see Figs. 4C and 5E of Shima).
Therefore, claim 10 is unpatentable over Shima, et al. and Humblet, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bock, et al. (US 2013/0130215)
Catt, et al. (US 2014/0005499)
Simpson, et al. (US 2016/0324463)
McNair (US 10,779,763)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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