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 .
Response to Arguments
Applicant’s arguments, see Applicant’s Response after final, filed 5/18/2026, with respect to the rejections of claims 1, 30, 36 and 72 under Keenan US 2024/0252820 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Van den Heuvel et al. US 2025/0082927, which has a provisional priority date of 8/24/2021 to provisional application No. 63/236,489. The provisional as well as the US Patent Publication both discloses sublingual electrodes to monitor EMG with the electrodes either placed externally or implanted in a sublingual location (paragraph 0034 of each document).
Applicant argues, in the after final received on 5/18/2026 that Keenan does not disclose implanted electrodes. This is not entirely accurate. Paragraph 0007 discloses prior art implanted electrodes. However, to expedite prosecution the rejections previously made are replaced the rejections found below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, any step of implanting and/or obtaining EMG data from implanted sensors in a sublingual region is not found in any of the associated drawings and must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
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.
Claim 1 is 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 1 recites “obtaining EMG data using a sensor implanted in a sublingual region of a patient”. This language is indefinite in that it is unclear if there should be a step of implanting sublingual EMG electrodes or if the obtaining is occurring in some other manner. There are no associated flow charts within the specification which specify an implanting step or that the EMG sensor data is specifically obtained from an implanted sublingual EMG electrode.
Claims 17-22, 25-27 and 30 are also rejected in that they depend from previously rejected claims.
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.
Claims 1, 17-22, 25-27, 30, 36, 50-52, 54-55, 58-60 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan US 2024/0252820 in view of Van den Heuvel et al. US 2025/0082927.
Regarding claims 1, 30, 36 and 72: Keenan discloses electrodes 10 (figure 1) which are used to sense EMG signals from the upper airway muscles, disclosed as under the tongue which is sublingual as well as stimulating the hypoglossal nerve (paragraph 0037). Keenan further discloses a processor and memory (figure 4, paragraph 0041). Keenan further discloses that EMG data (“EMG waveforms”, paragraph 0041) is obtained and the controller uses the waveforms. Figure 6 of Keenan demonstrates a genioglossus EMG (GGEMG) waveform in the middle of the graph, which is used to determine inspiration and expiration (paragraph 0056). The GGAV is the envelope waveform which is calculated (paragraph 0043). Stimulation is applied slightly before the onset of inspiration, which would be before the inspiration onset (paragraph 0055 “As the goal is to maintain upper airway patency, and prevent an obstruction, rather than recover from an airway block, it is advantageous to stimulate prior to the onset of inspiration.” “As it is critical that stimulation occur before the end of expiration.” “The level of confidence can be based on but not limited to the variance in the cycle-to-cycle time, where the variance would provide high confidence in the calculation, and higher variance would mean lower confidence and therefore a greater error margin and offset to be subtracted from the inspiratory time prediction and therefore earlier stimulation start time. The predicted inspiratory onset is denoted in FIG. 11 by tik+1 and is calculated as: [ti-1k+1 = tek + (tik – tek-1) – e] where e signifies error or the level of variance, with high variance meaning high error and larger correction factor to ensure stimulation starts prior to the beginning of inspiration.”)
However, although Keenan discloses prior art electrodes which are implanted (paragraph 0007), Keenan does not specifically disclose that the electrodes of the Keenan device are implanted in a sublingual location to sense EMG. Van den Havel however teaches of a medical implant to treat sleep disordered breathing (title) which implanted in a recipient’s body to apply stimulation (abstract). Van den Havel further discloses sensors and sensor circuitry for EMG sensing which is either positioned externally (as in Keenan) or implanted at a sublingual location (paragraph 0034). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Keenan to include either external or implanted EMG electrodes, as taught by Van den Havel, in order to sense muscle fatigue (Van den Havel, paragraph 0034).
Regarding claims 17 and 50: Keenan discloses determining the inspiration onset comprises predicting the inspiration onset based on the envelope of the EMG waveform (paragraphs 0009-10, 0042, 0045, 0052 claims 9 and 11).
Regarding claims 18 and 51: Keenan discloses predicting the inspiration onset based on previous EMG data of a previous respiratory cycle (paragraphs 0009-10, 0042, 0045, 0052, 0055, claim 22).
Regarding claims 19 and 52: Keenan discloses determining a time parameter for a previous respiration cycle, based on the previous EMG data, and predicting a time of the inspiration onset of an upcoming respiratory cycle based on the time parameter (paragraph 0055, claim 22).
Regarding claim 20: Keenan discloses that the time parameter for a previous respiration cycle includes inspiration onset time tik+1 (paragraph 0055) and an expiration onset time tek (paragraph 0055).
Regarding claims 21 and 54: Keenan discloses detecting a candidate breath (considered a previous breath), and determining if it is a valid breath and predicting onset of inspiration based on the candidate breath (paragraph 0055).
Regarding claim 22, 25-26, 55 and 58-59: Keenan discloses using machine learning (paragraph 0047). The machine learning is utilized to identify the genioglossal muscle for proper stimulation to the appropriate muscle. The EMG signal is used for pattern recognition, this would inherently require inputting the EMG or features of the EMG which would also include a value and magnitude of the EMG.
Regarding claims 27 and 60: Keenan discloses that the feedback process is a continuous loop which would assess the perdition at each step of the feedback loop, as can be seen in the equation in paragraph 0055 the time parameters are used in the feedback process in order to establish error (paragraph 0055).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mauger et al. US 2023/01310862 discloses an implant to treat sleep disordered breathing (title). In the Mauger device and method stimulation to the hypoglossal nerve is used to move the tongue (paragraphs 0013, 0022 and 0025). Implanted sublingual EEG sensors are also used (paragraph 0025).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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