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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on February 16, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/06/22, 12/15/23, 04/06/24, 09/20/24 and 02/16/26 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on February 16, 2026, amended claims 1, 15 and 20 have been entered.
Response to Arguments
With respect to the amendments, Examiner has rejected claims 1, 3-7, 15 and 17-23 under U.S.C. 101 and U.S.C. 103. Please see corresponding headings below for more detail, updated citations (Hampapuram reference), and updated obviousness rationale
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, 3-7, 15 and 17-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method comprising: determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert, within a predetermined prediction horizon; automatically shortening the predetermined prediction horizon associated with the alert based on the non-glucose data indicating that the predetermined time period has passed following the first instance of the alert without receiving the acknowledgement of the alert”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“causing output of a first instance of the alert in a user interface of a computing device responsive to the determining; receiving non-glucose data indicating that a predetermined time period has passed following the first instance of the alert without receiving an acknowledgement of the alert from a user; and causing output of a subsequent instance of the alert in the user interface according to the shortened prediction horizon”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., mere receiving data, displaying of data and/or outputting. See Palerm [pg. 82: col.2 par. 1-2; Examiner notes Palerm was cited in Applicant’s IDS submitted on 09/20/24], which shows the importance of the relationship between alarm frequency and length of prediction horizons
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art.
Independent claim 20 is also not patent eligible for substantially similar reasons
Regarding claim 15, the claim recites a system comprising: determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert, within a predetermined prediction horizon; automatically shortening the predetermined prediction horizon associated with the alert based on the non-glucose data indicating that the predetermined time period has passed following the first instance of the alert without receiving the acknowledgement of the alert”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“one or more processors; and a computer-readable storage medium storing instructions that are executable by the one or more processors to perform operations; causing output of a first instance of the alert in a user interface of a computing device responsive to the determining; receiving non-glucose data indicating that a predetermined time period has passed following the first instance of the alert without receiving an acknowledgement of the alert from a user; and causing output of a subsequent instance of the alert in the user interface according to the shortened prediction horizon”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., mere processing, storing and displaying of data and/or outputting. See Palerm [pg. 82: col.2 par. 1-2], which shows the importance of the relationship between alarm frequency and length of prediction horizons
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art.
Dependent claims 3-7, 15, 17-19 and 21-23 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1, 3-7, 15 and 17-23 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5, 15, 17, and 19, 20 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hampapuram (U.S. Patent Application Publication 2019/0059826).
Regarding claims 1, 15, and 20, Hampapuram teaches a method comprising: determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert within a predetermined prediction horizon [par. 80]; causing output of a first instance of the alert in a user interface of a computing device responsive to the determining [par. 80]; receiving non-glucose data indicating that a predetermined time period has passed following the first instance of the alert without receiving an acknowledgement of the alert from a user [par. 82, 83, 160]; the predetermined prediction horizon defining how far into a future time period predicted glucose values are considered relative to the threshold value [par. 172, 175]; and causing output of a subsequent instance of the alert in the user interface according to the shortened predetermined prediction horizon [par. 152, 160, 175]
Although Hampapuram does not explicitly teach automatically shortening the predetermined prediction horizon associated with the alert based on the non-glucose data indicating that the predetermined time period has passed following the first instance of the alert without receiving the acknowledgement of the alert from the user, this would be obvious to one having ordinary skill in the art when the invention was filed since Hampapuram also suggests information influences the prediction horizon includes adaptive learning algorithms that can learn what each individual’s lag time is and apply a unique setting [par. 126]. Additionally, Hampapuram teaches a reactivation criteria after the acknowledged time has expired, and adjusting criteria for “re-alert” [par. 175]. Therefore, incorporating automatically shortening the predetermined prediction horizon associated with the alert based on the non-glucose data indicating that the predetermined time period has passed following the first instance of the alert without receiving the acknowledgement of the alert from the user would only involve routine skill in the art
Regarding claims 3 and 17, Hampapuram further teaches the additional data describing the response to the alert includes at least one of: data describing food consumed by a user associated with the CGM system; data describing insulin administered to the user associated with the CGM system; or data describing exercise activity for the user associated with the CGM system [par. 192 “processor module 214 may be configured to determine if a user has taken some sort of action independent of the sensor during the predetermined time period post-alert trigger. For example, the user may have eaten or increased insulin since the initial alarm, which would likely lead to a noticeable change in glucose levels.”]
Regarding claims 4 and 18, Hampapuram further teaches the automatic shortening is further based on information describing a user's interactions with an application associated with the CGM system [par. 77].
Regarding claims 5 and 19, Hampapuram further teaches the at least one glucose value predicted by the CGM system is predicted based on historical glucose measurement patterns for a user of the CGM system [par. 98, 107].
Regarding claim 21, Hampapuram further teaches determining that a second at least one glucose value predicted by the CGM system satisfies the threshold value for the alert, wherein: the causing output of the subsequent instance of the alert is performed responsive to the determining that the second at least one glucose value satisfies the threshold value for the alert [par. 155, 174, 175].
Regarding claim 22, Hampapuram further teaches the method is executed by an application on the computing device, the application providing the user interface.
Regarding claim 23, Hampapuram further teaches the method is executed by a CGM platform in communication with the computing device [par. 65, 221].
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hampapuram and in further view of Lucisano (U.S. Patent Application Publication 2018/0279911).
Lucisano was applied in the previous office action
Regarding claims 6 and 13, Hampapuram teaches a method comprising: determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert, as disclosed above, and non- glucose data indicating that an acknowledgement of the alert was not received from the user
However, Hampapuram does not teach the data indicates that the first instance of the alert is a nuisance alert, and the automatic shortening is responsive to determining that the first instance of the alert is a nuisance alert
Lucisano teaches the data indicates that the first instance of the alert is a nuisance alert, and the automatic shortening is responsive to determining that the first instance of the alert is a nuisance alert [par. 174];
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Hampapuram, to incorporate the data indicates that the first instance of the alert is a nuisance alert, and the automatic shortening is responsive to determining that the first instance of the alert is a nuisance alert, for preventing overly disrupting the user, as evidence by Lucisano [par. 174].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hampapuram and in further view of Mault (U.S. Patent Application Publication 2003/0208113).
Mault was applied in the previous office action
Regarding claim 7, Hampapuram teaches a method comprising: determining that at least one glucose value predicted by a continuous glucose monitoring (CGM) system satisfies a threshold value for an alert, as disclosed above
However, Hampapuram does not teach receiving data describing one or more glucose measurements observed by the CGM system during a future time period; comparing the at least one glucose value predicted by the CGM system with the one or more glucose measurements observed by the CGM system during the future time period; and adjusting the prediction horizon based on a difference between the at least one glucose value predicted by the CGM system and the one or more glucose measurements observed by the CGM system during the future time period.
Mault teaches receiving data describing one or more glucose measurements observed by the CGM system during a future time period; comparing the at least one glucose value predicted by the CGM system with the one or more glucose measurements observed by the CGM system during the future time period; and adjusting the prediction horizon based on a difference between the at least one glucose value predicted by the CGM system and the one or more glucose measurements observed by the CGM system during the future time period [par. 15, 66].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Hampapuram, to incorporate receiving data describing one or more glucose measurements observed by the CGM system during a future time period; comparing the at least one glucose value predicted by the CGM system with the one or more glucose measurements observed by the CGM system during the future time period; and adjusting the prediction horizon based on a difference between the at least one glucose value predicted by the CGM system and the one or more glucose measurements observed by the CGM system during the future time period, for allowing the accuracy of the model to be checked, and can be used to modify the model used so as to provide more accurate blood glucose projections, as evidence by Mault [par. 15].
Allowable Subject Matter
Claims 8 and 10-14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
As to Claims 8 and 10-14, neither Hampapuram nor the prior art of record teaches receiving non-glucose data indicating that an acknowledgement of the alert was received from a user after a predetermined time period following the first instance of the alert; automatically shortening the predetermined prediction horizon associated with the alert based on the non-glucose data indicating that the acknowledgement of the alert was received from the user after the predetermined time period.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791