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 .
Claim Objections
Claim 22 is objected to because of the following informalities: Claim 22 recites “brain brain” in lines 3-4, but instead should omit one of the “brain.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 11 and 22 recite the use of a model for predicting future glucose, but fail to provide details of the model. The specification merely recites that machine learning model can be used but fails to specify what the components of the model are (¶[0047]). Therefore, the model is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor had possession of the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-12, 14-20, and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “at least 2-8 hours” in line 6, but it is indefinite. Does the limitation intend to be interpreted as “at least 2 or 8 hours” or “at least 2 through 8 hours”? For examination purposes, the limitation is interpreted as reciting “or.”
Claim 23 fails to depend on an independent claim. Based on the limitation, it appears that it is dependent on Claim 21 due to its incorporation of the predicted and actual glucose measurements. However, there is not a stated model in Claim 21. For examination purposes, the claim will be interpreted as being dependent on Claim 21. Clarification required.
Claims not listed are rejected by virtue of claim dependency.
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 11-12 and 14-23 are rejected under 35 U.S.C. 101 because 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.
STEP 1
Regarding claims 11, 21, and 23, the claims recites a series of steps or acts, including:
predicting future glucose levels of the patient at least 2-8 hours in the future in claims 11 and 21; and
confirming the accuracy of the predicted future glucose levels in claim 21.
Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of predicting future glucose levels of the patient at least 2-8 hours in the future and confirming the accuracy of the predicted future glucose levels sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claims fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 11 and 22 recites providing a warning based on the predicted future glucose levels, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The prediction nor the confirmation provide an improvement to the technological field, the methods do not effect a particular treatment or effect a particular change based on the prediction or confirmation, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, claims 11 and 21-22 recite additional steps of recording a brain activity signal and decoding the brain activity signal using a trained prediction model. Recording and decoding brain activity is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the recording and decoding steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data processing. The recording and decoding steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 (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 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 11, 13-15 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al. (US 20130274580-Previously cited), hereinafter Madsen, and further in view of Wexler et al. (US 20210241916), hereinafter Wexler.
Regarding claim 11, Madsen teaches recording a brain activity signal of a user's brain using a non-invasive scalp worn brain signal recorder (¶[0041], “multiple electrodes to gather EEG signals,” “[t]hese may be positioned on the scalp of the patient,” “[w]hen outside the skull at least, preferred positions for the electrodes will be such as (P4-T6), (P4-T4), (P3-T5), or (P3-T3) in the standard EEG 10-20 system”);
using a trained prediction model (¶[0068], “coefficients are obtained by training signal processing unit in a process of machine learning”), decoding the brain activity signal to predict future glucose levels of the patient (see abstract, EEG signals are measured and processed to determine future hypoglycemia event, e.g., predicting future glucose levels); and
providing a warning to the user on a personal device about the predicted future glucose levels (¶[0083], “The alarm emitted by the Hypo Detector block may activate an alarm signal generator to output a physically perceivable alarm signal such as a sound or vibration or mild electrical shock perceivable by a user of said apparatus.” and “ The analysis of the EEG and the generation of any form of alarm signal may, as tasks, be split between an implanted module connected to the EEG electrodes and an external module communicating with the internal module, as described in WO2006/066577 and in WO2009/090110.” (emphasis added) The disclosure of WO2006/066577 teaches that the external module for alarm generation is incorporated into a “pocket computer device.” ).
Madsen fails to teach wherein the predicted glucose levels of the patient are at least 2-8 hours in the future.
Wexler teaches a system for measuring and predicting health metric such as, blood glucose, to assess whether the person has diabetes and/or prediabetes (abstract and ¶[0022]). The system requires generating a forecast of the blood glucose values that may be expected 30 days, and therefore more than at least 2 or 8 hours in the future (¶[0031,0053], “The user devices 104 can be any device associated with a user or patient, and can be used to obtain health metric data (e.g., blood pressure data, blood glucose data, weight data)” and “generate a forecast of metabolic health metric values that may be expected 30 days from the start of the forecast process execution”).
As such it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed, to have modified the device of Madsen, such that the predicted glucose levels of the patient are at least 2-8 hours in the future, as taught by Wexler, to aid in determining whether a person has diabetes and/or prediabetes.
Regarding claim 12, Madsen teaches providing a warning when estimated glucose levels rise above a threshold value (see para. [0011,0047,0066], “The alarm detector continuously monitors the output from the integrator block. When the integrated evidence passes a certain threshold, the evidence of impending hypoglycemia is high enough for the unit to emit a hypoglycemia alarm signal”).
Regarding claim 13, Madsen teaches wherein the brain signal recorder is selected from the group consisting of an electroencephalography (EEG) (see para. [0010]).
Regarding claim 14, Madsen teaches decoding the brain activity to a multivariate decoder trained on spectral profiles of intracranial activity (see para. [0058], one skill in the art understands that an event classifier is a type of multivariate decoder).
Regarding claims 15, Madsen teaches wherein the brain activity signal describes the spectral profile of the broadband brain activity (see para. [0049], “Each feature normalization block (1:N) (in FIG. 1) receives the full EEG stream” one of ordinary skill in the art understands that a full EEG stream comprises broadband brain activity).
Regarding claims 20, Madsen teaches wherein the glucose level consists of blood glucose level (see para. [0011], “In accordance with the present invention, the detection of hypoglycemia or impending hypoglycemia may be conducted by detecting EEG signal patterns that are associated with a blood glucose level”).
Regarding claim 21, Madsen teaches a computer executable method executable by one or more processors, the method comprising:
receiving brain activity signal of a user's brain from a non-invasive scalp-worn brain signal recorder (¶[0041], “multiple electrodes to gather EEG signals,” “[t]hese may be positioned on the scalp of the patient,” “[w]hen outside the skull at least, preferred positions for the electrodes will be such as (P4-T6), (P4-T4), (P3-T5), or (P3-T3) in the standard EEG 10-20 system”); and
decoding the brain activity signal to predict future glucose levels of the user (see abstract, EEG signals are measured and processed to determine future hypoglycemia event, e.g., predicting future glucose levels);
Madsen fails to teach receiving blood glucose levels from a continuous glucose monitor worn by the user; and confirming the accuracy of the predicted future glucose levels using the blood glucose levels received from the continuous glucose monitor.
Wexler teaches a system for measuring and predicting health metric such as, blood glucose, to assess whether the person has diabetes and/or prediabetes (abstract and ¶[0022]). The system requires comparing the predicted blood glucose with the actual blood glucose measurement to determine the accuracy of the model, and therefore the prediction (¶[0070], “For example, the trained model(s) can be used to predict metabolic health metric values in a test set. The predicted metrics can then be compared to the actual metrics to determine the accuracy of the model(s). If the model accuracy is not satisfactory, the model(s) can be re-trained, e.g., using additional and/or different training sets. Optionally, different candidate feature sets can be compared (e.g., based on accuracy of the resulting training model(s)), and the feature set that generated the best testing performance can be selected for future use.” The system requires measuring the blood glucose with a continuous glucose monitoring sensor or the-like (¶[0032]).
As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Madsen, such that blood glucose levels from a continuous glucose monitor worn by the user are received and the accuracy of the predicted future glucose levels using the blood glucose levels received from the continuous glucose monitor is confirmed, as taught by Wexler, to aid in assessing whether the person has diabetes and/or prediabetes using a satisfactory model.
Regarding claim 23, Madsen fails to teach refining the model using predicted levels and subsequent validation as measured using the continuous glucose monitor.
Wexler teaches that model is retrained (refined) when the accuracy of the output is deemed unsatisfactory, based on the predicted glucose and actual glucose, with new data to improve the models accuracy of the predicted blood glucose (¶[0070]). As such, the accuracy of the prediction of whether the person has diabetes and/or prediabetes also improves.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Madsen, such that the model is refined using predicted levels and subsequent validation as measured using the continuous glucose monitor, as taught by Wexler, to aid in improving the accuracy of predicting whether the person has diabetes and/or prediabetes.
Regarding claim 22, Madsen teaches a computer executable method executable by one or more processors (¶[0111]), the method comprising:
receiving brain activity signal of a user's brain from a non-invasive scalp-worn brain signal recorder (¶[0041], “multiple electrodes to gather EEG signals,” “[t]hese may be positioned on the scalp of the patient,” “[w]hen outside the skull at least, preferred positions for the electrodes will be such as (P4-T6), (P4-T4), (P3-T5), or (P3-T3) in the standard EEG 10-20 system”);
and decoding the brain activity signal to predict future glucose levels of the patient using a trained model (¶[0041], “multiple electrodes to gather EEG signals,” “[t]hese may be positioned on the scalp of the patient,” “[w]hen outside the skull at least, preferred positions for the electrodes will be such as (P4-T6), (P4-T4), (P3-T5), or (P3-T3) in the standard EEG 10-20 system”);
and providing a warning to the user on a personal device about the predicted future glucose levels (¶[0083], “The alarm emitted by the Hypo Detector block may activate an alarm signal generator to output a physically perceivable alarm signal such as a sound or vibration or mild electrical shock perceivable by a user of said apparatus.” and “ The analysis of the EEG and the generation of any form of alarm signal may, as tasks, be split between an implanted module connected to the EEG electrodes and an external module communicating with the internal module, as described in WO2006/066577 and in WO2009/090110.” (emphasis added) The disclosure of WO2006/066577 teaches that the external module for alarm generation is incorporated into a “pocket computer device.” ).
Madsen fails to teach wherein the model is trained on data from the user. However, the model of Wexler is trained on user data to aid in predicting whether the user has diabetes or prediabetes (¶[0070,0077,0101]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Madsen, such that the model is trained on data from the user, as taught by Wexler, to aid in improving the accuracy of predicting whether the person has diabetes and/or prediabetes.
Claims 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Madsen and Wexler, as applied to claim 11, and further in view of Grosman et al. (US 20160256629- Previously cited), hereinafter Grosman.
Regarding claims 16 and 17, Madsen-Wexler fails to disclose delivering a therapy to the user based on the predicted future glucose levels in order to manage glucose levels in a desired therapeutic range; wherein the therapy is insulin provided via an insulin pump.
Grosman teaches a closed loop insulin infusion system that is configured to provide therapy to a user based on the predicted glucose level and manage the user’s glucose (see abstract and para. [0540,0593,0634], insulin pump 1436).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Madsen-Wexler, such that therapy is delivered to the user based on the predicted future glucose levels in order to manage glucose levels in a desired therapeutic range and wherein the therapy is insulin provided via an insulin pump, as taught by Grosman, to aid in treating hypoglycemic attacks (see para. [0002] of Grosman). Additionally, the modification is merely combining prior art elements (glucose measuring methods) according to known methods (insulin infusion therapy) to yield predictable results.
Regarding claim 19¸ Madsen teach storing the predicted future glucose level in the memory (see para. [0014]), but fails to teach validating the predicted future glucose level based on a measured glucose level received from a glucose monitor.
Grosman teaches wherein the model calculated the predicted sensor glucose value and compares it against the actual senso glucose value to aid in generating appropriate alerts, warnings, or otherwise take corrective action (see para. [0593]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Madsen-Wexler, such that the predicted future glucose level based on a measured glucose level received from a glucose monitor, as taught by Grosman, to aid in generating appropriate alerts, warnings, or otherwise take corrective action.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Madsen in view of Wexler and Grosman, as applied to claim 16, further in view of Kist et al. (Persistent blood glucose reduction upon repeated transcranial electric stimulation in men-AUG 2017- Previously cited), hereinafter Kist.
Regarding claim 8, Madsen-Wexler-Grosman fail to teach wherein the therapy is brain stimulation.
Kist teaches that transcranial direct current stimulation aids in managing blood glucose concentrations (see Abstract and Result section).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Madsen-Wexler-Grosman, such that the therapy is brain stimulation, as taught by Kist, to aid in lowering/controlling a user’s blood glucose (see conclusion of Kist). Additionally, the modification is merely applying a known technique (brain stimulation) to a known methods (blood glucose measurements) ready for improvement to yield predictable results.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to 35 U.S.C. 101, 102, and 103 claims have been considered but are moot because amendments require new grounds of rejection.
Additionally, due to the amendments, the nonstatutory double patenting rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Randloev et al. teaches glucose monitoring systems to provide real-time test results it remains desirable to more reliably predict glucose level fluctuations in the near future, e.g. half an hour or an hour ahead. US 20140073892
Constantin teaches the system may compare predicted values to actual values to assess model parameters. US 20190252079
Wexler teaches continuous blood glucose monitoring, for the purposes of predicting blood glucose levels and/or an occurrence of a hyperglycemic event or hypoglycemic event (or any other event) during a predetermined period of time (e.g., within the next 15 minutes, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, or overnight). US 20200375549
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791