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 .
Prosecution History Summary
Claims 1-20 are cancelled.
Claims 21 and 31 are amended.
Claims 21-40 are pending.
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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 31-40), machine (claims 21-30). Accordingly, claims 21-40 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 21 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
A server, comprising:
-a memory comprising executable instructions;
-a processor in data communication with the memory and configured to execute the instructions to cause the server to:
-store calculated bolus values provided by a bolus calculator;
-receive real-time continuous glucose monitoring (CGM) data from a CGM system;
-detect at least one of a pattern of user modifications to the calculated bolus values or one or more user-initiated departures in delivered insulin boluses relative to the calculated bolus values;
-determine a difference between the calculated bolus values and the modified bolus values associated with the at least one of the pattern of user modifications or the one or more user-initiated departures in the delivered insulin boluses;
-calculate a glucose trend based on the real-time CGM data;
-identify a patient activity to reduce the difference based on the calculated glucose trend; and
-provide a notification recommending the patient activity to reduce the difference.
Examiner states submits that the foregoing underlined limitations constitute: “certain methods of organizing human activity” because managing a patient’s bolus based on continuous monitoring to notify the patient of recommended activity is managing personal behavior.
Furthermore, the foregoing underlined limitation constitute: a “mental process” because determining the difference in calculated bolus values and modified bolus values to identify a patient activity to reduce difference can all be performed in the human mind.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception 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.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim 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 server (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 103), comprising:
-a memory comprising executable instructions (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 114);
-a processor in data communication with the memory and configured to execute the instructions to cause the server to (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 90, 102-103):
-store calculated bolus values provided by a bolus calculator;
-receive real-time continuous glucose monitoring (CGM) data from a CGM system (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 24);
-detect at least one of a pattern of user modifications to the calculated bolus values or one or more user-initiated departures in delivered insulin boluses relative to the calculated bolus values;
-determine a difference between the calculated bolus values and the modified bolus values associated with the at least one of the pattern of user modifications or the one or more user-initiated departures in the delivered insulin boluses;
-calculate a glucose trend based on the real-time CGM data;
-identify a patient activity to reduce the difference based on the calculated glucose trend; and
-provide a notification recommending the patient activity to reduce the difference.
Thus, taken alone, the additional elements do not integrate the at least one abstract idea 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, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or 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 a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2).
For these reasons, representative independent claim 31 and analogous independent claim
21 do not recite additional elements that integrate the judicial exception into a practical
application. Accordingly, representative independent claim 31 and analogous independent claim
21 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claim 22, 32: The claims specify the processor to transmit an indication of the patient activity for approval, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 23, 33: The claims specify identifying patient activity from an external app, user input, or CGM system, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 24, 34: The claims specify the processor causing the server to authenticate the external app or data from external app prior to use, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 25, 35: The claims specify identifying the patient activity based on several parameters, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claim 26, 36: The claims specify identifying the patient activity based on historical data, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claim 27-29, 37-39: The claims specify patient activity, which does no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the use of at least one abstract idea is performed (see MPEP 2106.05(h)).
Claim 30, 40: The claims specify the processor to cause the server to identify a modification to bolus calculator to supplement patient activity to reduce the difference, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 21 and 31 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as receive CGM data, detect pattern of user modifications, provide a notification, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); store calculated bolus values, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv); calculate a glucose trend, determine a difference, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 22, 24, 30, 32, 34, and 40, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 22, 32 (transmit an indication of the patient activity for approval), e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 30, 40 (identify a medication to a parameter or setting of the bolus calculator), e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii); claims 24, 34 (authenticate data prior to use), e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). 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 functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 21-40
are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
Claims 21-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agrawal et al. (U.S. Publication No. 2013/0345663).
As per claim 21, Agrawal teaches a server (Agrawal: para. 72), comprising:
-a memory comprising executable instructions (Agrawal: para. 76);
-a processor in data communication with the memory and configured to execute the instructions to cause the server to (Agrawal: para. 75):
-store calculated bolus values provided by a bolus calculator (Agrawal: para. 164; Store bolus dosage from the bolus calculator.);
-receive real-time continuous glucose monitoring (CGM) data from a CGM system (Agrawal: para. 197; Glucose data from CGM received in real-time.);
-detect at least one of a pattern of user modifications to the calculated bolus values or one or more user-initiated departures in delivered insulin boluses relative to the calculated bolus values (Agrawal: para. 107-108; para. 170; figure 7B; Manual bolus detection is recorded and presented as a graph to show pattern. Detecting user-initiated bolus delivery and time it occurs and the triggering event.);
-determine a difference between the calculated bolus values and the modified bolus values associated with the at least one of the pattern of user modifications or the one or more user-initiated departures in the delivered insulin boluses (Agrawal: figure 2k; para. 113; para. 178-181; para. 214-215; Analyzes the trend of bolus delivery events and checked against bolus data and generating an output based on the analysis.);
-calculate a glucose trend based on the real-time CGM data (Agrawal: para. 198; Analyze the filtered sensor glucose data for trends.);
-identify a patient activity to reduce the difference based on the calculated glucose trend (Agrawal: para. 173); and
-provide a notification recommending the patient activity to reduce the difference (Agrawal: para. 229; The recommendation is outputted.).
As per claim 22, the server of claim 21 is as described. Agrawal teaches wherein the processor is configured to cause the server to transmit an indication of the patient activity to a health care professional for approval (Agrawal: figure 19, 1314; figure 22, 1344; para. 229).
As per claim 23, the server of claim 21 is as described. Agrawal teaches wherein the identifying of the patient activity is based on data from an external software application, user input, or a continuous glucose monitoring system (Agrawal: para. 13).
As per claim 24, the server of claim 23 is as described. Agrawal teaches wherein the processor is further configured to cause the server to authenticate or validate the external software application or the data from the external software application prior to use in the identifying of the patient activity (Agrawal: para. 79; Received information from devices are authenticated.).
As per claim 25, the server of claim 21 is as described. Agrawal teaches wherein the identifying of the patient activity is based on one or more of a carbohydrate count, fat intake, protein intake, meal size, insulin-to-carb ratio, glucose target, glucose threshold, insulin action time, and glucose trend (Agrawal: para. 150).
As per claim 26, the server of claim 21 is as described. Agrawal teaches wherein the identifying of the patient activity is based on patient historical data (Agrawal: figure 32; para. 151).
As per claim 27, the server of claim 21 is as described. Agrawal teaches wherein the patient activity corresponds to a patient sleep schedule (Agrawal: para. 151).
As per claim 28, the server of claim 21 is as described. Agrawal teaches wherein the patient activity corresponds to a patient exercise schedule (Agrawal: para. 151).
As per claim 29, the server of claim 21 is as described. Agrawal teaches wherein the patient activity corresponds to a patient diet (Agrawal: para. 151).
As per claim 30, the server of claim 21 is as described. Agrawal teaches wherein the processor is configured to cause the server to identify a modification to a parameter or setting of the bolus calculator to supplement the patient activity to reduce the difference (Agrawal: figure 17).
Claims 31-40 recite substantially similar limitations as those already addressed in claims 21-30, and, as such, are rejected for similar reasons as given above.
Response to Arguments
Applicant's arguments filed for claims 21-40 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues that the “receive…CGM data from a CGM system,” “calculate glucose trend based on…CGM data,” “identify patient activity…,” and “provide a notification” are limitations that recite processor-based processing and cannot be performed in the human mind. While the claims require various processors, which are in the physical realm of things, it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources to have invented, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. Neither the claims nor the specification calls for any parallel processing system different from those available in existing systems. Using a computer to gather and analyze data embodies the most basic functions of a computer. All of these computer functions are well-understood, routine, and conventional activities previously known to the industry. Each step does no more than require a generic computer to perform conventional computer functions. Applicant does not assert that there is any unconventional use of a computer, and the use of conventional computer components to perform conventional steps to implement an abstract idea has repeatedly been found to not make an abstract idea patent eligible. See Alice, 573 U.S. at 217-18 (Instructing one to “apply” an abstract idea and reciting no more than generic computer elements performing generic computer tasks does not make an abstract idea patent eligible.).
Applicant argues that the claims apply real-time CGM data processing and glucose trend calculation in a server-based bolus management system providing a concrete, technology-based implementation. The use of the term “real-time” does not disqualify the limitation from being categorized as an abstract idea. Language such as concurrently, automatically, instantly, or simultaneously to describe the automation of a manual process is not enough to overcome a subject matter eligibility rejection (MPEP § 2106.05(a)(I). Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality no. (iii) mere automation of manual processes. Examiner also notes that language such as this is not restricted to computer processes, humans can automatically/instantly/simultaneously complete different tasks (see MPEP § 2106.04(a)(2)(III) stating that the mental processes may be completely by humans plural – not just a singular human mind).
Applicant's arguments filed for claims 21-40 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues that Agrawal does not disclose storing “calculated bolus values,” detecting “a pattern of user modifications to the calculated bolus values,” and “a difference between the calculated bolus values and the modified bolus values.” Examiner has provided Agrawal’s interpretation with the claimed language and points the Applicant to the rejection. Examiner does not see the difference between the prior art and the claimed limitations and therefore, maintains the rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Steil et al. – U.S. Publication No. 2020/0268968 –Teaches a diabetes management system.
Mensinger et al. – U.S. Publication No. 2014/0012117 – Teaches a system for CGM and providing boluses.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marc Jimenez can be reached on (571) 272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3686