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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/23/2026, 05/08/2025, 02/21/2025 and 11/27/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of invention (I) drawn to claims 1-6, and withdrawn claims 7-11 from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “EEG” in line 3 should be amended to read – electroencephalography EEG--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “a subject” in line 3 should be amended to read –the subject--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “future glucose levels” in line 6 should be amended to read –the future glucose levels--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the phrase “EEG” in line 3 should be amended to read – electroencephalography EEG--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the phrase “a subject” in line 3 should be amended to read –the subject--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the phrase “future glucose levels” in line 6 should be amended to read –the future glucose levels--. Appropriate correction is required.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claims 1 and 5 recite a series of method steps to determine future glucose levels. Thus, the claims are directed to a process. which is one of the statutory categories of invention.
STEP 2A PRONG ONE: Claims 1 and 5 recite(s) specific limitations/method steps of: sensing EEG signals from a subject; processing the sensed EEG signals; analyzing the processed EEG signals with a trained forecasting model and forecasting future glucose levels of the subject; and visually present information that is indicative of the forecasted future glucose levels.
These limitations recite a mental process, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). For example, a caregiver can use any type of sensor to measure glucose levels and predict the future glucose levels if the patient does not take his/her medications and/or does not follow a healthy diet. Thus, the claims are drawn to a Mental Process, which is an Abstract Idea. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
STEP 2A PRONG TWO: Claims 1 and 5 does not recite additional elements that integrates the judicial exception into a practical application. Claims 1 and 5 recites the following additional elements beyond the judicial exception: A) behind-the-ear EEG device, B) personal device, and C) display. Accordingly, the combination of the additional element/step A-C does not integrate the exception into a practical application of the exception because the use of EEG sensor and personal device with a display is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)).
Accordingly, each of the additional elements or a combination of the additional elements do not integrate the abstract idea into a practical application as they fail to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: Claims 1 and 5 does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, A) behind-the-ear EEG device, B) personal device, and C) display. The combination of elements A-C of EEG sensor and personal device with a display does not amount to significantly more than the judicial exception because the use of EEG sensor and personal device with a display is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)). Furthermore, the elements A-C are well-understood, routine, and conventional, as is evidenced by Byrd et al (US 20160256086), SUH YONG JOON et al (KR 20220111015), and Boesem et al (US 20210077025) which all show EEG sensor and personal device with a display as claimed in claims 1 and 5 evidencing that these elements are well-understood, route, and conventional in the applanation arts.
Accordingly, the additional elements individual or in co do not integrate the abstract idea into a practical application as they fail to recite additional element(s) 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.
When viewed alone or in combination, the limitations of claims 1-6 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, claims 1-6 are not patent eligible under 35 USC 101.
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 1-6 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1 and 5 recite the limitation “analyzing the processed EEG signals with a trained forecasting model”, the current specification fails to disclose the specific trained forecasting model in a manner to allow one of ordinary skill in the art to make or use the invention. Claimed trained forecasting model must be disclosed as either a flowchart showing the process that is taken by the processor to process the incoming data to provide the desired output, or the actual algorithm must be shown in order to allow one of ordinary skill in the art the ability to make or use the current invention without undue experimentation.
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 1-6 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.
Claims 1 and 5 recite the limitation “analyzing the processed EEG signals with a trained forecasting model”, this limitation is not defined by the claims, which renders the claims indefinite. The specification does not disclose the algorithm/flowchart showing the process that is taken by the trained model to output the future glucose levels, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim remains indeterminate because of the claimed “analyzing the processed EEG signals with a trained forecasting model”.
Examiner respectfully notes for purpose of examination the claimed trained model will be interpreted as any machine learning/algorithm/computer program that analysis EEG signals to predict future glucose levels.
Claim 1 recites the limitation "the-ear" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the-ear" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being obvious over Cranwell et al ("Utilizing Brain Activity to Non-Invasively Predict Blood Glucose Levels”, NPL # 43 in IDS mailed on 11/27/2024) in view of Byrd et al (US 2016/0256086).
As to claims 1 and 4-6, Cranwell teaches a method of forecasting future glucose levels of a subject (a method of predicting a user's blood glucose level 'BGL'; page 2, first paragraph), comprising:
sensing EEG signals from a subject with an EEG device (sensing EEG signals using an EEG device; page 1, last paragraph; page 2, first paragraph and page 22);
processing the sensed EEG signals (features extracted from an EEG; page 24, first paragraph);
with processor, analyzing the processed EEG signals with a trained forecasting model and forecasting future glucose levels of the subject (a trained artificial neural network 'ANN' is used to analyze the EEG signals and predict future glucose levels of the user; page 2, first paragraph; page 5, first paragraph, page 23 and page 56); and
causing the processor to visually present on a display information that is indicative of the forecasted future glucose levels (visually presenting BGL data predicted in the graph in pages 58-61 shows predicted blood glucose level for the future period).
Still regarding claims 1 and 4-6, Cranwell teaches the invention substantially as claimed above, wherein a plurality of EEG sensors are placed on the user’s scalp (as best see in fig.10 and 18), but failed to explicitly teach a behind-the-ear EEG device, an application on a personal device; causing the personal device to visually present on a display information, and communicating the sensed EEG signals to the personal device.
However, Byrd teaches an analogous system for determining blood glucose level using EEG sensors (abstract, par.14, par.19, par.36, par.49 and par.57, fig. 1-3), wherein the EEG sensor is a behind-the-ear EEG device (EEG electrode 304(4) behind the ear in eyeglasses 302, par.49, par.54-55, and par.57, fig.3),
with an application on a personal device analyzing EEG signals (analyzing measured biological data, such as, EEG, using application/program in processor of wearable device 302 and/or 200, par.34, par.37, par.39 and par.54);
causing the personal device to visually present on a display information (eyeglasses 302 can further include a display device 316 to provide information via a display area 318 on a lens of the eyeglasses. In various examples, the device 302 can use the display area to provide indications of biological conditions, par.62), and
communicating the sensed EEG signals to the personal device (eyeglasses 302 can communicate bioelectric signal data via Bluetooth to a user's smartphone for one or more of digital signal processing, analysis, or display; par.62, fig.1).
Since glucose behind the ear EEG sensors are well-known in the art, so it would have been obvious to one having an ordinary skill in the art before the effective filing date of the invention to substitute the EEG sensor taught by Cranwell’s invention with behind the ear EEG sensor, taught by Byrd’s invention, for the same purpose of continuous measurement of glucose level in a wearable device that is more ergonomic and convenient device, and presenting/displaying the data in a manner that is convenient and easily accessible to the wearer, as taught by Byrd’s invention (par.62).
As to claim 2, Cranwell teaches the method, wherein the information that is indicative of the forecasted future glucose levels includes a future period of time and forecasted glucose levels during the future period of time (predicting the third hour in page 57, BGL data predicted in the graph in pages 58-61 shows predicted blood glucose level for the future period of time).
As to claim 3, Cranwell teaches the method, wherein the information that is indicative of the forecasted future glucose levels comprises a graph with time on a first axis and forecasted glucose levels on a second axis (the graph in pages 58-61 represents future BGL on the vertical axis and the future period on the horizontal axis).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
