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 .
DETAILED ACTION
This action is in reference to the communication filed on 27 AUG 2025.
Amendments to claims 1, 13, 25 entered and considered, as is the cancellation of claims 4, 16, 28.
Claims 1-3, 5-15, 17-27, 29-36 are present and have been examined.
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, 5-15, 17-27, 29-36 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-3, 5-15, 17-27, 29-36 the independent claim(s) 1, 13, 25 recite(s) a method, a system, and a computer program product, falling into the statutory category of process, machine, and manufacture respectively.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-3, 5-15, 17-27, 29-36 independent claim(s) (claims 1, 13, 25) is/are directed, in part, to:
receiving CGM data profiles of said subject;
extracting glycemic risk profiles from the CGM data profiles;
compressing the CGM data profiles into low-dimensional representations using a trained
transmitting said low-dimensional encoded representations of CGM profiles to a secondary source,
reconstructing said low-dimensional representations of CGM profiles to full-dimensional CGM profiles via a
wherein said compressing step and said reconstructing step defines encryption and decryption, respectively,
wherein:
said transmitted reconstructed full-dimensional CGM profiles are configured to allow:
b) an
response to receiving said transmission to improve the safety and/or efficacy of therapy for said subject
and wherein said improvement of the safety and/or efficacy of therapy for said subject may include one or more of the following: preventing a hypoglycemic event(s) from occurring in said subject: preventing a hyperglycemic event(s) from occurring in said subject; reducing excessive glucose variability occurring in said subject; reducing postprandial glucose excursions occurring in said subject; reducing the risk for hypoglycemia; reducing the risk for hyperglycemia: optimizing delivery of antidiabetic drugs/compounds (including, insulin); or lowering glycated hemoglobin (HbA 1c).
These claim elements are considered to be abstract ideas, because they are directed in pertinent part to mental processes. The receiving, extracting, compressing, transmitting, are all examples of concepts performed in the human mind such as observation, judgement, evaluation, and opinion.
Examiner further notes that the compression by cost function weighed is directed in pertinent part to a mathematical concept – the weighting function is an example of a mathematical formula, equation and/or calculation.
Examiner further notes that mitigating harmful events for a person is arguably an interaction designed to mitigate risk for the person.
If a claim limitation, under its broadest reasonable interpretation, covers any of: a) observation, evaluation, judgement, opinion b) mathematical formulas/equations/calculations, c) certain methods of organizing human activity, then respectively the claim recites abstract idea(s) of mental processes, mathematical concepts, and methods of organizing human activity.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements: a “neural network” and “interventional device” common to all independent claims. Claim 1 recites a “computer” implemented method, claim 13 includes a computer process, a memory configured to store instructions, and claim 25 includes a computer program product and non-transitory computer readable storage medium, to perform the claimed limitations. The “neural network” and “interventional device” common to all claims is found to be no more than a general link between the use of the judicial exception to a particular technological environment or field of use (see MPEP 2106.05h). Similarly, the computing elements identified in claims 1, 13, 25 are found to be analogous to adding the words “apply it”/ mere instructions to implement an abstract idea on a computer and/or merely using the computer as a tool to perform the abstract idea (see MPEP 2106.05f). No improvement to the functioning of the computing elements, the neural network nor interventional device(s) is found (see MPEP 2106.05a), nor is any meaningful limitation beyond generally linking the use of the judicial exception to a particular technological environment, and as such that the claim as a whole is no more than a drafting effort (see MPEP 2106.05e). Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as a “neural network” and “interventional device” common to all independent claims. Claim 1 recites a “computer” implemented method, claim 13 includes a computer process, a memory configured to store instructions, and claim 25 includes a computer program product and non-transitory computer readable storage medium, to perform the claimed limitations.. When considered individually, the “neural network, interventional device,” and the aforementioned computing claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0100] At step 507, the system compresses the CGM data profiles into low-dimensional representations using a trained neural network encoder via a cost function weighted by said extracted glycemic risk profiles. The neural networks at step 507 can include one or more artificial neural networks (ANNs), convolutional neural networks (CNNs), or recurrent neural networks (RNNs). More specifically, the CNN can be an autoencoder.
[0102] In embodiment, the interventional device may include one or more of anyone of the following: insulin pump device; decision support system; low glucose suspend system; connected insulin pens; automated insulin delivery systems; or intelligent patch or intelligent transplant (as well as any other available interventional devices).
[0024] FIG. 2 is a high-level functional block diagram of an embodiment of the present invention, or an aspect of an embodiment of the present invention. As shown in FIG. 2, a processor or controller 102 communicates with the glucose monitor or device 101 (or other interventional or diagnostic device), and optionally the insulin device 100 or an artificial pancreas. The glucose monitor or device 101 (or other interventional or diagnostic device) communicates with the subject 103 to monitor glucose levels of the subject 103. The processor or controller 102 is configured to perform the required calculations. Optionally, the insulin device 100 (or artificial pancreas) communicates with the subject 103 to deliver insulin to the subject 103. The processor or controller 102 is configured to perform the required calculations. The glucose monitor 101 (or other interventional or diagnostic device) and the insulin device 100 (or artificial pancreas) may be implemented as a separate device or as a single device. The processor 102 can be implemented locally in the glucose monitor 101, the insulin device 100, or a standalone device (or in any combination of two or more of the glucose monitor, insulin device, interventional device, diagnostic device or a stand along device). The processor 102 or a portion of the system can be located remotely such that the device is operated as a telemedicine device.
These passages, as well as others (including [025-030]), makes it clear that the invention is not directed to a technical improvement. The additional elements are described in capability features only – i.e. any intermediary device, or neural network, or processing environment is suitable for use in the claim as long as capable of the functions identified. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims:
Claims 2, 3, 5, 6, 14, 15, 17, 18, do not recite any additional abstract ideas or additional elements, rather these claims elaborate on the additional elements identified above – i.e. the interventional device, the sources/memory, and the neural network. These claims provide context to the claimed invention, however, as discussed above these elements are insufficient to support a finding of significantly more.
Claims 10, 11, 22, 23, are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as goals of the interventions, and means of processing or filtering the data sets. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Claims 7, 8, 9, 19, 20, 21, 31, 32, 33 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above –specifically elements of the mathematical concepts/equations/relationships. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Non-Obvious Subject Matter
Claims 1-3, 5-15, 17-27, 29-36 are believed to be free of the prior art rejection in view of the amendments/remarks as made by Applicant in the 8/27/25 response.
Response to Arguments
Applicant’s remarks as filed on 27 AUG 2025 have been fully considered.
Applicant’s remarks regarding the rejection of claims 12, 24, 46 is found persuasive, and as such rejection is withdrawn.
Applicant’s remarks regarding the 101 rejection begin in earnest on page 26, with a recitation of elements of exemplary claim 1, and concludes that a practical application is present. Similar, on page 26, 27, Applicant repeats limitations of claim 1. Applicant appears to assert on page 27 that the claims represent an improvement to the functioning of a CGM system. Examiner respectfully disagrees, and counters that the CGM functioning itself is not improved by the encrypted data, rather, the additional elements as identified in the sending and receiving of the data are being applied to the CGM itself. Similarly on page 28, this is an application of the technology of the transmission technology, rather than an improvement to the CGM itself.
Applicant concludes a practical application on page 28, Examiner respectfully disagrees at least of the reasons identified above. Examiner does not find that a technical problem is solved or identified. Examiner again reiterates that the device is not improved by the transmission means of the data as claimed. For example, the functioning of a printer to print is not affected by the means through which the picture or document is received at the printer – wirelessly vs. hard lined. The printer’s functionality to print, in dispensing ink and such, is not changed or improved by this difference.
Applicant’s amendments and remarks have been found persuasive and as such the rejections under 35 USC 103 have been withdrawn.
Conclusion
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 KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687