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
The amendment submitted on 2/2/2026 is sufficient to overcome the drawing objections and 35 USC § 112 rejections.
Applicant's arguments filed 2/2/2026 with respect to the 35 USC § 112 rejections under Keenan US 2024/0252820 have been fully considered but they are not persuasive.
Applicant argues that Keenan fails to disclose “delivering stimulation energy to a hypoglossal nerve of the patient before the inspiration onset”, see page 11 of applicants response dated 2/2/2026. The arguments presented surround the claim language:
Claim 1, lines 7-8 recite: “delivering stimulation energy to a hypoglossal nerve of the patient before the inspiration onset”.
Claim 36, lines 14-15 recite: “delivering the stimulation energy via the electrode to the hypoglossal nerve before the inspiration onset”.
Claim 72, lines 9-10 recite: “delivering stimulation energy to a hypoglossal nerve of the patient before the inspiration onset.”
Applicant further points out that the main goal of Keenan is to provide stimulation only during inspiration to prevent muscle fatigue, see paragraph 0055 of Keenan. However, also in paragraph 0055 of Keenan the following statements are made:
“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.”
These recitations alone demonstrate that the stimulation begins prior to the onset of inspiration by an error factor to insure that the entire respiration cycle is receiving stimulation to prevent the occurrence of an obstruction and not merely treat the obstruction once it has occurred. As is known in the art there respiration cycle includes inspiration and expiration with a pause between inspiration and expiration (see Ser et al. US 11,000,223, column 11, lines 34-45). Therefore the stimulation of Keenan is begins during this pause prior to the onset of inspiration in order to stimulate during the entire inspiration cycle. Applicant further points to figure 12 of Keenan which shows Δt=67ms, in this graph is clear that stimulation is initiated prior to the onset of inspiration. The rejections are not withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 30, 36 and 72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keenan US 2024/0252820.
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, considered to be sublingual, as well as stimulate 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.”)
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.
Ser et al. US 11,000,223, column 11, lines 34-45 discuss the respiration cycle which includes inspiration, expiration and a pause between inspiration and expiration.
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.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796