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 .
Status of Claims
Claims 1-12 and 14-20, as recited in an RCE filed on August 18, 2025, were previously pending and subject to a non-final office action filed on December 19, 2025 (the “December 19, 2025 Non-Final Office Action”). On March 19, 2026, Applicant submitted amendments to claims 1, 15, and 16 (the “March 19, 2026 Amendment”). As such, claims 1-12 and 14-20, as recited in the March 19, 2026 Amendment, are currently pending and subject to the final office action below.
Response to Applicant’s Remarks
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 112(a)
Applicant’s arguments, see Applicant’s Remarks, p. 9, Claim Rejections under 35 U.S.C. § 112 Section, filed March 19, 2026, with respect to the claims rejections of claims 1-12 and 14-20 under 35 U.S.C. § 112(a), have been fully considered, but they are moot in light of Applicant’s amendments to independent claims 1, 15, and 16. Specifically, Applicant amended the claims to delete the limitations directed to “comparing the real-time activity data to an activity parameter associated with each candidate behavior modification feedback in the behavior library”; “suppressing, from the candidate set, each behavior modification feedback whose associated activity parameter is already satisfied by the real-time activity data at or above a compliance condition”; and “selecting, from the plurality of behavior modification feedback, the at least one behavior modification feedback remaining after the suppressing to improve glucose levels corresponding to the pattern, the selecting based on a recency of the detected pattern and a priority ranking of the plurality of behavior modification feedback” in claims 1, 15, and 16. These limitations were deemed to be new matter and lacked written description support in the specification. Applicant has amended the claims to remove the offending limitations. As such, the claim rejections of claims 1-12 and 14-20 are no longer necessary and are hereby withdrawn in light of the amendments.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks, pp. 9-17, Claim Rejections under 35 U.S.C. § 101 Section, filed March 19, 2026, with respect to rejections of claim 1-12 and 14-20 under 35 U.S.C. § 101 have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 1-12 and 14-20 are maintained in this office action.
First, Applicant argues that the claims do not recite an abstract idea. See Applicant’s Remarks, at pp. 10-12 (under Subsection 1 of the Claim Rejections under 35 U.S.C. § 101 Section). Examiner respectfully disagrees. This argument was addressed in previous office actions. See the August 27, 2025 Final Office Action, at pp. 3-4 and the December 19, 2025 Non-Final Office Action, at pp. 3-4. While Applicant asserts that the claims do not recite an abstract idea within any of the groupings of abstract ideas, the claims recite limitations which amount to an abstract idea within the Mental Processes grouping of abstract ideas. See MPEP § 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. MPEP §2106.04(a)(2)(III) (citing CyberSource Corp. v. Retail Decisions, Inc.). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. MPEP §2106.04(a)(2)(III). The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. Id. Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. Id. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Id.
In the present case, independent claims 1, 15, and 16 recite limitations directed to: (1) generating one or more features (i.e., described broadly as “any value that can be computed from the glucose measurements in paragraph [0056] of Applicant’s original specification as filed on October 26, 2022) from the glucose measurements for a first time period (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could evaluate the glucose measurements and make an observation/judgment/opinion that the glucoses levels are “good” or “bad”); (2) detecting a pattern in the glucose measurements (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually identify trends in the glucose measurements); (3) mapping the pattern to a plurality of behavior modification feedback based on at least one of a time or a duration of the pattern (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually associate the pattern of glucose measurements to the plurality of behavior modification feedback based on least one of a time or a duration of the pattern); (4) filtering out behavior data modification feedback indicating to perform activity that the activity data indicates the user is already performing (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually remove feedback data that the user is already performing based on mentally analyzing the user’s activity data); and (5) selecting a behavior modification to improve glucose levels corresponding to the pattern (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually select the patient’s behavior in order to improve the glucose levels observed in the detected pattern). These steps amount to different types of observations, evaluations, judgments, and/or opinions that are reasonably performed in the human mind or with the aid of pen and paper. Therefore, the aforementioned claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person, such as a healthcare professional.
Further, while Examiner agrees that the steps and features for obtaining the glucose measurements from a user with a glucose sensor and displaying the behavior modification feedback on a user interface are not part of an abstract mental process (these features are additional elements which require analysis under Prong Two of Step 2A), these features do not automatically mean that the claims cannot be directed to an abstract idea within the mental processes grouping. A significant portion of the claims recite an abstract mental process that a person is capable of performing (see above, such as the steps for generating the features; detecting the pattern; mapping the pattern; filtering out the behavior modification; and selecting the behavior modification). Accordingly, the claims are directed to an abstract mental process and this argument is still not persuasive for this reason.
Next, Applicant asserts that the claims integrate the abstract idea into a practical application, because the claims recite an improvement in technology. See Applicant’s Remarks, at pp. 12-15 (under Subsection 2 of the Claim Rejections under 35 U.S.C. § 101 Section). Examiner respectfully disagrees. This argument was also addressed in previous office actions. See the August 27, 2025 Final Office Action, at pp. 4-5 and the December 19, 2025 Non-Final Office Action, at pp. 4-5. When evaluating whether claims recite an improvement to the functioning of a computer or a technical field, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. MPEP § 2106.05(a). The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Id.
Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. In the present case, Applicant has not identified a technical problem, nor has Applicant explained the details of an unconventional technical solution expressed in the claims. First, Applicant argues that the system, devices, and method improve system resource management and sensor operation by dynamically modifying the frequency at which glucose measurements are produced when patterns are not detected. See Applicant’s Remarks, at p. 13. Examiner respectfully disagrees with this assertion, because Applicant’s system, device, and method do not actually modify the frequency of the glucose measurements dynamically.
Rather, the claimed invention merely sends a notification to the user via the user interface to indicate that frequency of the measurements may be reduced when the system identifies that no patterns are detected. This limitation does not change the frequency of measurements dynamically, because it still would require the user to make the change after receiving the notification. This limitation merely amounts to sending a notification, like an alert, when no patterns are detected. Sending a notification to user through a device is similar to receiving/transmitting data over a network, which courts have recognized as insignificant extra-solution activity. See MPEP § 2106.05(g) (citing Intellectual Ventures v. Symantec).
Second, Applicant argues that the claims provide an improvement by improving the accuracy and reliability of automated user input by incorporating the activity tracker data into the behavior modification feedback selection process. See Applicant’s Remarks, at p. 14. Examiner respectfully disagrees with this assertion. The improvement has to be to the functioning of computers or an improvement to other technology or technical field. See MPEP § 2106.05(a). It is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. Id. For example, in Trading Technologies Int’l v. IBG, the Federal Circuit determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology. Id. Similarly, the step directed to filtering out behavior modification feedback indicative of activity that the user is already performing at best improves the abstract idea by reducing/eliminating behavior modification feedback that corresponds to activities that the user is already performing. However, this step does not improve computer technologies or a technical field.
Third, Applicant argues that the claims improve the safety and responsiveness of the glucose level monitoring system by prioritizing the display of behavior modification feedback associated with immediate safety risks. See Applicant’s Remarks, at p. 14. Examiner respectfully disagrees with this assertion. Similar to the previous argument, this final step in the independent claims is not indicative of an improvement to the functioning of computers or an improvement to other technology or technical field. See MPEP § 2106.05(a). Similar to the user interface in Trading Technologies Int’l, this step provides an improvement to the abstract idea at best, because it merely selects certain data to display to the user (i.e., behavior modification feedback associated with “immediate safety risks”). Applicant’s claims have not described a new or improved way for identifying immediate safety risks. Rather, displaying the behavior modification feedback associated with immediate safety risks still amounts to receiving and transmitting data over a network (i.e., insignificant extra-solution activity), because it merely represents data outputting and does not impose meaningful limits on the claims (i.e., displaying data related to immediate safety risks is generic and generally well-known in the medical industry). Accordingly, the claims do not recite additional elements that amount to an improvement in technology.
Lastly, Applicant argues that the claims provide an inventive concept that amounts to significantly more than the abstract idea. See Applicant’s Remarks, at pp. 15-17 (under Subsection 3 of the Claim Rejections under 35 U.S.C. § 101 Section). Examiner respectfully disagrees. Again, this argument was also addressed in previous office actions. See the August 27, 2025 Final Office Action, at p. 5 and the December 19, 2025 Non-Final Office Action, at p. 5. First, Applicant argues again the features recited in the claims “define a specialized physiological data processing operation” which “enables the monitoring system to dynamically adjust sensor measurement frequency based on analysis of glucose data, thereby reducing unnecessary sensing operations, lowering processing workload, and improving overall power efficiency of the monitoring device”. See Applicant’s Remarks, at p. 16. However, as identified above in the response to the technological improvement arguments, Applicant’s claims do actually not adjust the frequency of the glucose monitoring dynamically. As the Examiner described above, sending a notification to the user via the user interface to indicate that frequency of the measurements may be reduced when the system identifies that no patterns are detected does not change the frequency of measurements dynamically, because it still would require the user to make the change after receiving the notification. This limitation merely amounts to sending a notification, like an alert, when no patterns are detected. Sending a notification to user through a device is similar to receiving/transmitting data over a network, which courts have recognized as insignificant extra-solution activity. See MPEP § 2106.05(g) (citing Intellectual Ventures v. Symantec). Therefore, this feature is not indicative of providing significantly more than the abstract idea.
Second, Applicant asserts that the claims provide significantly more than the abstract idea, because “the specification explains that high-priority behavior modification feedback may be immediately communicated when an immediate safety risk exists”. See Applicant’s Remarks, at p. 16. Examiner respectfully disagrees with this assertion. As identified above in the response to the technological improvement arguments, selecting certain data to display to the user (i.e., behavior modification feedback associated with “immediate safety risks”) is not indicative of significantly more than the abstract idea because it is deemed to be well-understood, routine, and conventional activity in the medical field. Applicant’s claims do not describe a new or improved way for identifying immediate safety risks. Rather, displaying the behavior modification feedback associated with immediate safety risks still amounts to receiving and transmitting data over a network (i.e., insignificant extra-solution activity), because it merely represents data outputting and does not impose meaningful limits on the claims (i.e., displaying data related to immediate safety risks is generic and generally well-known in the medical industry).
Despite Applicant’s assertions and analysis, the claims merely recite an abstract idea implemented on computer devices. Examiner asserts that the method of selecting behavior modification feedback for improving glucose levels described in Applicant’s claims represents a well understood, routine, and conventional process in the medical industry, because healthcare professionals routinely receive a patient’s glucose and activity data when deciding which feedback to provide to the user in order to improve the user’s glucose levels. Accordingly, the claims do not recite additional elements that amount to significantly more than the abstract idea.
As such, the claims are not deemed to be patent eligible under § 101 based on the 2019 Revised PEG. Therefore, the rejections of claims 1-12 and 14-20 under 35 U.S.C. § 101 are maintained in this office action. Please see amended rejections to claims 1-12 and 14-20 under 35 U.S.C. § 101 below, for further clarification and analysis of the claims under the 2019 Revised PEG.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
- "a glucose measurement collection module"; "a feature determination module"; "a pattern detection module"; "mapping module"; and "a behavior modification selection module", in claim 16;
- "a normalization module", in claim 19; and
- "a behavior modification feedback customization module", in claim 20.
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.
If applicant does not intend to have these limitations 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 § 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 1-12 and 14-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1-12 and 14 are directed to a method implemented in a continuous glucose monitoring system, which is within one of the four statutory categories (i.e., a process). See MPEP § 2106.03. Claim 15 is directed to a computing device, which is also within one of the four statutory categories (i.e., a machine or apparatus). See id. Claims 16-20 are also directed to a device, which is also within one of the four statutory categories (i.e., a machine or apparatus). See id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1-12 and 14-20 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1, 15, and 16 include limitations that recite an abstract idea. Specifically, independent claim 15 recites the following limitations:
A computing device comprising:
a processor;
a display device; and
computer-readable storage media having stored thereon multiple instructions of an application that, responsive to execution by the processor, cause the processor to:
obtain, from a glucose sensor of a continuous glucose level monitoring system and for each time window of multiple time windows, glucose measurements measured for a user for a first time period of multiple time periods of the time window, the glucose sensor being inserted at an insertion site of the user;
generate, from the glucose measurements, one or more features for the first time period of the multiple time windows;
detect, from the one or more features for the first time period of the multiple time windows, a pattern in the glucose measurements in the first time period of the multiple time windows;
map the pattern to a plurality of behavior modification feedback in a behavior library based on at least one of a time or duration of the pattern;
receive real-time activity data for the user from an activity tracker or other external device;
filter out behavior modification feedback indicating to perform activity that the activity data indicates the user is already performing;
select, from the plurality of behavior modification feedback, at least one behavior modification feedback to improve glucose levels corresponding to the pattern, the selecting based on a recency of the detected pattern and a priority ranking of the plurality of behavior modification feedback;
generate a user interface including the behavior modification feedback;
in response to identifying that no patterns are detected for the first time period, notify the user via the user interface that a frequency with which the glucose measurements are obtained can be reduced;
cause the user interface to display the at least one behavior modification feedback; and
when an immediate safety risk exists based on the at least one behavior modification feedback, immediately display the safety risk to the user via the user interface.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., a method for diabetes management, comprising: generating one or more features from glucose measurements for a first time period; detecting a pattern in the glucose measurements; mapping the pattern to a plurality of behavior modification feedback based on at least one of a time or duration of the pattern; filtering out behavior modification feedback that the user is already performing; and selecting a behavior modification to improve glucose levels corresponding to the pattern). That is, other than reciting some computer components and functions (the foregoing limitations in claim 15 which are not underlined), the context of claims 1, 15, and 16 encompasses concepts that are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., a method for diabetes management, comprising: generating one or more features from glucose measurements for a first time period; detecting a pattern in the glucose measurements; mapping the pattern to a plurality of behavior modification feedback based on at least one of a time or duration of the pattern; filtering out behavior modification feedback that the user is already performing; and selecting a behavior modification to improve glucose levels corresponding to the pattern).
The aforementioned claim limitations described in claims 1, 15, and 16 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) generating one or more features (i.e., described broadly as “any value that can be computed from the glucose measurements in paragraph [0056] of Applicant’s original specification as filed on October 26, 2022) from the glucose measurements for a first time period (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could evaluate the glucose measurements and make an observation/judgment/opinion that the glucoses levels are “good” or “bad”); (2) detecting a pattern in the glucose measurements (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually identify trends in the glucose measurements); (3) mapping the pattern to a plurality of behavior modification feedback based on at least one of a time or a duration of the pattern (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually associate the pattern of glucose measurements to the plurality of behavior modification feedback based on least one of a time or a duration of the pattern); (4) filtering out behavior modification feedback that the user is already performing (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually remove feedback data that the user is already performing based on mentally analyzing the user’s activity data); and (5) selecting a behavior modification to improve glucose levels corresponding to the pattern (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually select the patient’s behavior in order to improve the glucose levels observed in the detected pattern). Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person, such as a healthcare professional. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(III). Accordingly, claims 1, 15, and 16 recite an abstract idea that falls within the Mental Processes category.
Furthermore, Examiner notes that dependent claims 2, 3, 6-12, 14, and 17-20 include limitations which further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 4, 5, 19, and 20 include limitations that are deemed to be additional elements, and require further analysis under Prong Two of Step 2A; and (2) dependent claims 2, 3, 6-12, 14, 17, and 18 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A. For example, claims 2, 3, 6, 8, and 17 merely recite specific ranges for the time periods that the glucose measurements are taken from (i.e., these steps are deemed to be reasonably performed mentally or manually using a pen and paper, because they modify the data that is used for the observations, evaluations, judgments, and/or opinions). Similarly, claims 7, 9-12, 14, and 18 merely recite for making determinations and selecting the type of the behavior modification feedback (i.e., these steps are deemed to be reasonably performed mentally or manually using a pen and paper, because they recite additional observations, evaluations, judgments, and/or opinions). Further, claim 19 includes limitations for the detected patterns being related to one or more features where certain criteria is not satisfied; and claim 20 includes a limitation for generating numeric values for glucose measurements (i.e., these steps are deemed to be reasonably performed mentally or manually using a pen and paper, because they recite additional observations, evaluations, judgments, and/or opinions).
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP § 2106.05(h).
In the present case, for independent claim 15, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A computing device comprising (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
a processor (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
a display device (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)); and
computer-readable storage media having stored thereon multiple instructions of an application that, responsive to execution by the processor, cause the processor to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
obtain, from a glucose sensor of a continuous glucose level monitoring system and for each time window of multiple time windows, glucose measurements measured for a user for a first time period of multiple time periods of the time window, the glucose sensor being inserted at an insertion site of the user (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that this additional element amounts to generally linking the abstract idea to a particular field of use or technological environment as noted below, see MPEP § 2106.05(h); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
generate, from the glucose measurements, one or more features for the first time period of the multiple time windows;
detect, from the one or more features for the first time period of the multiple time windows, a pattern in the glucose measurements in the first time period of the multiple time windows;
map the pattern to a plurality of behavior modification feedback in a behavior library based on at least one of a time or duration of the pattern;
receive real-time activity data for the user from an activity tracker or other external device (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
filter out behavior modification feedback indicating to perform activity that the activity data indicates the user is already performing;
select, from the plurality of behavior modification feedback, at least one behavior modification feedback to improve glucose levels corresponding to the pattern, the selecting based on a recency of the detected pattern and a priority ranking of the plurality of behavior modification feedback;
generate a user interface including the behavior modification feedback (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
in response to identifying that no patterns are detected for the first time period, notify the user via the user interface that a frequency with which the glucose measurements are obtained can be reduced (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
cause the user interface to display the at least one behavior modification feedback (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)); and
when an immediate safety risk exists based on the at least one behavior modification feedback, immediately display the safety risk to the user via the user interface (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)).
However, the recitation of these generic computer components and functions in claim 15 are recited at a high-level of generality (i.e., using generic computer devices to perform the abstract idea of: a method for diabetes management, comprising: generating one or more features from glucose measurements for a first time period; detecting a pattern in the glucose measurements; mapping the pattern to a plurality of behavior modification feedback based on at least one of a time or duration of the pattern; filtering out behavior modification feedback that the user is already performing; and selecting a behavior modification to improve glucose levels corresponding to the pattern), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
- The following is an example of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations (e.g., see MPEP § 2106.05(f)):
- A commonplace business method or mathematical algorithm being applied on a general purpose computer, e.g., see Alice Corp. Pty. Ltd. v. CLS Bank Int’l – similarly, the current invention implements the commonplace medical business method of detecting patterns in data and providing feedback based on the detected patterns using generic computing devices (i.e., the Examiner submits that the additional elements directed to the computing device, comprising a processor; display device; computer-readable storage media storing multiple instructions of an application; and user interface, are generic computer devices).
- The following is an example of an insignificant extra-solution activity (e.g., see MPEP § 2106.05(g)):
- Example of Mere Data Gathering/Mere Data Outputting:
- Obtaining information about transactions using the Internet to verify credit card transactions, e.g., see CyberSource v. Retail Decisions, Inc. – similarly, the steps directed to: (1) “obtaining from a glucose sensor of a continuous glucose level monitoring system and for each time window of multiple time windows, glucose measurements measured for a user for a first time period of multiple time periods of the time window, the glucose sensor being inserted at an insertion site of the user” and “receiving real-time activity data for the user from an activity tracker or other external device”, described in claims 1, 15, and 16, are a necessary data gathering steps (i.e., obtaining the glucose measurements and receiving the real-time activity data are necessary in order for the device to be able to detect the patterns and provide the behavior modification feedback); and (2) “generating a user interface including the behavior modification feedback”; “in response to identifying that no patterns are detected for the first time period, notifying the user via the user interface that a frequency with which the glucose measurements are obtained can be reduced”; “causing the user interface to display the at least one behavior modification feedback”; and “when an immediate safety risk exists based on the at least one behavior modification feedback, immediately displaying the safety risk to the user via the user interface”, amounts to necessary data outputting steps.
- The following are examples of generally linking the use of a judicial exception to a particular technological environment or field of use (e.g., see MPEP § 2106.05(h)):
- (1) Specifying that the abstract idea of monitoring audit log data relates to transactions or activities that are executed in a computer environment, because this requirement merely limits the claims to the computer field, i.e., to execution on a generic computer, FairWarning v. Iatric Sys.; (2) Specifying that the abstract idea of using advertising as currency is used on the Internet, because this narrowing limitation is merely an attempt to limit the use of the abstract idea to a particular technological environment, Ultramercial, Inc. v. Hulu; and (3) Requiring that the abstract idea of creating a contractual relationship that guarantees performance of a transaction (a) be performed using a computer that receives and sends information over a network, or (b) be limited to guaranteeing online transactions, because these limitations simply attempted to limit the use of the abstract idea to computer environments, buySAFE Inc. v. Google, Inc. - similarly, the limitations directed to the “a glucose sensor of a continuous glucose level monitoring system” amounts to limiting the abstract idea to the field of glucose monitoring devices. See MPEP 2106.05(h).
Thus, the additional elements in independent claims 1, 15, and 16 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 2, 3, 6-12, 14, 17, and 18 do not recite any additional elements outside of those identified as being directed to the abstract idea described above. Examiner notes that dependent claims 4, 5, 19, and 20 recite the following additional elements identified in bold font below (with limitations deemed to be part of the above identified abstract idea identified in underlined font):
further comprising receiving user input specifying, for each of the multiple time periods, the multi-hour period of time during the day for the time period (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 4);
further comprising automatically learning, by a machine learning system, at least one of the multi-hour periods of time of the day (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f); and the Examiner further submits that this additional element amounts to generally linking the abstract idea to a particular field of use or technological environment as noted below, see MPEP § 2106.05(h)) (as described in claim 5);
wherein the pattern is one of multiple patterns detected in the glucose measurements, each of the multiple patterns being one of the one or more features for which corresponding criteria is not satisfied, and the device further comprising a normalization module, implemented at least in part in hardware (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), to normalize the multiple patterns to generate a size for each of the multiple patterns (as described in claim 19); and
further comprising a behavior modification feedback customization module, implemented at least in part in hardware (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)), to generate a numeric value for the user based on the glucose measurements or the one or more features, and customize the behavior modification feedback to the user by including at least one numeric value in the behavior modification feedback (as described in claim 20).
As such, the additional elements in claims 1, 4, 5, 15, 16, 19, and 20 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-12 and 14-20: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-12 and 14-20 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1-12 and 14-20 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of abstract idea into a practical application, the additional elements of claims 1, 4, 5, 15, 16, 19, and 20 amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP § 2106.05(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1, 4, 5, 15, 16, 19, and 20, as recited, the computing device; device; continuous glucose level monitoring system; processor; display device; computer-readable storage media having stored thereon multiple instructions of an application; behavior library; glucose sensor; glucose measurement collection module; feature determination module; pattern detection module; behavior modification selection module; user interface; machine learning system; normalization module; behavior modification feedback customization module; and the steps of: “obtaining from a glucose sensor of a continuous glucose level monitoring system and for each time window of multiple time windows, glucose measurements measured for a user for a first time period of multiple time periods of the time window, the glucose sensor being inserted at an insertion site of the user”; “receiving real-time activity data for the user from an activity tracker or other external device”; “generating a user interface including the behavior modification feedback”; “in response to identifying that no patterns are detected for the first time period, notifying the user via the user interface that a frequency with which the glucose measurements are obtained can be reduced”; “causing the user interface to display the at least one behavior modification feedback”; and “when an immediate safety risk exists based on the at least one behavior modification feedback, immediately displaying the safety risk to the user via the user interface”; “receiving user input specifying, for each of the multiple time periods, the multi-hour period of time during the day for the time period”; and “automatically learning, by a machine learning system, at least one of the multi-hour periods of time of the day”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- In regard to the computing device; device; continuous glucose level monitoring system; processor; display device; computer-readable storage media having stored thereon multiple instructions of an application; behavior library; glucose sensor; glucose measurement collection module; feature determination module; pattern detection module; behavior modification selection module; user interface; machine learning system; normalization module; behavior modification feedback customization module; and the steps of: “automatically learning, by a machine learning system, at least one of the multi-hour periods of time of the day”, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion. For example, Applicant discloses that: (1) the computing device may be a server or other suitable computing device (see Applicant’s original specification, as filed on October 26, 2022, paragraph [0143]); (2) the processing system may be configured as processors, semiconductors, and/or transistors (see Applicant’s original specification, as filed on October 26, 2022, paragraph [0145]); (3) the computer-readable media includes memory and storage devices, such as, RAM, ROM, flash memory, CD-ROM, DVD, optical storage, hard disks, etc. (see Applicant’s original specification, as filed on October 26, 2022, paragraph [0146]); and (4) the term module represents software, firmware, hardware, or a combination thereof (see Applicant’s original specification, as filed on October 26, 2022, paragraph [0148]). The Examiner submits that these devices represent well-understood, routine, and conventional computer devices which are known in the medical industry.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
- The Examiner submits that these limitations generally link the use of the judicial exception to a particular technological environment or field of use – for example, the limitations directed to: the continuous glucose level monitoring system; glucose sensor; and “automatically learning, by a machine learning system, at least one of the multi-hour periods of time of the day”, amounts to limiting the abstract idea to the fields of glucose monitoring devices and machine learning (see MPEP § 2106.05(h) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the steps and features directed to: “obtaining from a glucose sensor of a continuous glucose level monitoring system and for each time window of multiple time windows, glucose measurements measured for a user for a first time period of multiple time periods of the time window, the glucose sensor being inserted at an insertion site of the user”; “receiving real-time activity data for the user from an activity tracker or other external device”; “generating a user interface including the behavior modification feedback”; “in response to identifying that no patterns are detected for the first time period, notifying the user via the user interface that a frequency with which the glucose measurements are obtained can be reduced”; “causing the user interface to display the at least one behavior modification feedback”; and “when an immediate safety risk exists based on the at least one behavior modification feedback, immediately displaying the safety risk to the user via the user interface”; and “receiving user input specifying, for each of the multiple time periods, the multi-hour period of time during the day for the time period” - The following represents an example that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – the aforementioned limitations directed to: “obtaining from a glucose sensor of a continuous glucose level monitoring system and for each time window of multiple time windows, glucose measurements measured for a user for a first time period of multiple time periods of the time window, the glucose sensor being inserted at an insertion site of the user”; “receiving real-time activity data for the user from an activity tracker or other external device”; “generating a user interface including the behavior modification feedback”; “in response to identifying that no patterns are detected for the first time period, notifying the user via the user interface that a frequency with which the glucose measurements are obtained can be reduced”; “causing the user interface to display the at least one behavior modification feedback”; and “when an immediate safety risk exists based on the at least one behavior modification feedback, immediately displaying the safety risk to the user via the user interface”; and “receiving user input specifying, for each of the multiple time periods, the multi-hour period of time during the day for the time period”, are similarly deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere collection and transmission of data over a network (i.e., “obtaining/generating/receiving” and displaying data on an interface are the equivalent of receiving or transmitting data over a network).
Therefore, the additional limitations described in claims 1, 4, 5, 15, 16, 19, and 20 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above.
Thus, taken alone, the additional elements of claims 1, 4, 5, 15, 16, 19, and 20 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1, 4, 5, 15, 16, 19, and 20 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 2, 3, 6-12, 14, 17, and 18 (which depend on claims 1 and 16 due to their respective chains of dependency), do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that claims 2, 3, 6-12, 14, 17, and 18 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claims 1 and 16. Dependent claims 2, 3, 6-12, 14, 17, and 18 merely add limitations that further narrow the abstract idea described in independent claims 1 and 16. Therefore, claims 1-12 and 14-20 are also nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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