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 filed 8/3/2026, with respect to the drawing objections, 35 USC 101 rejection and the 35 USC 112b rejections have been fully considered and are persuasive. The drawing objections, 35 USC 101 rejection and the 35 USC 112b rejections have been withdrawn.
Applicant’s amendment has overcome the rejection with respect to Meadows. The 35 USC 102 rejection with respect to Meadows has been withdrawn.
Applicant's arguments filed 8/3/2026 regarding the prior art rejections have been fully considered but they are not persuasive. With respect to the art of Mashiach, Applicant argues “However, Mashiach's condition signal is based on movement or coupling information, not on a value indicative of a degree of airway opening or airway obstruction.” The Examiner respectfully disagrees. Mashiach discloses the degree of coupling between antennas that is measured reflects the movement of the tongue wherein the movement is indicative of an apnea event or a precursor to an apnea event. An apnea event is a greater degree of airway obstruction than a pre-cursor (par. [0199, 0212]). Specifically, snoring is a lesser obstruction than a full-on apnea event (par. [0212]) and Mashiach discloses the tongue movement can span the range of sleep disordered breathing to total obstruction (par. [0218]). Each of these are varying degrees of obstruction based on tongue movement and positioning.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4 and 7-10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mashiach et al. (2018/0221657).
Regarding Claims 1 and 10, Mashiach discloses a method for treating sleep apnea comprising an implantable stimulation system 110 having electrodes 158a, b (Fig. 1, 3; par. [0113]) associated with it. When an apnea event is detected, a modulation signal (electrical stimulation signal) is applied to the electrodes to interrupt the apnea event. Particularly, Mashiach discloses detecting movement of a muscle related to the subject’s airway (e.g. the tongue, which is a muscle associated with the airway, “The largest of the pharyngeal muscles responsible for upper airway dilation is the genioglossus muscle, which is one of several different muscles in the tongue. The genioglossus muscle is responsible for forward tongue movement and the stiffening of the anterior pharyngeal wall. In patients with OSA, the neuromuscular activity of the genioglossus muscle is decreased compared to normal individuals, accounting for insufficient response and contraction to open the airway as compared to a normal individual. This lack of response contributes to a partial or total airway obstruction, which significantly limits the effectiveness of the sleeper's breathing.”, par. [0004]); determining a type of obstruction from the movement of the tongue; and applying a stimulation signal based on the type of obstruction (par. [0210-0212]). Specifically, Mashiach discloses the degree of coupling between antennas that is measured reflects the movement of the tongue wherein the movement is indicative of an apnea event or a precursor to an apnea event. An apnea event is a greater degree of airway obstruction than a pre-cursor (par. [0199, 0212]). Specifically, snoring is a lesser obstruction than a full-on apnea event (par. [0212]) and Mashiach discloses the tongue movement can span the range of sleep disordered breathing to total obstruction (par. [0218]). Each of these are varying degrees of obstruction based on tongue movement and positioning. This device performs in a closed loop manner (not a one-time use) so the process flow would involve monitoring the movement of the tongue; determining if the movement is indicative of a small movement (possibly snoring) or a large movement (obstructed airway); apply the appropriate signal based on the assignment of the movement as snoring or obstruction; re-monitor and re-evaluate the tongue movement; and adjust stimulation based on the new assignment.
In regard to Claim 3, Mashiach discloses the movement of the muscle that is monitored is the position of the tongue and change of position of the tongue (small movement vibrations indicative of snoring or large movements indicative of airway obstruction, see par. [0212]).
Regarding Claim 4, Mashiach discloses the movement of the tongue is made with a motion sensing unit, particularly one that detects relative motion of a primary and secondary antenna (par. [0030]).
With regard to Claim 7, Mashiach discloses adjusting amplitude, pulse duration, frequency, etc. of a pulse train (par. [0081, 0190, 0210]; Fig. 17).
In regards to Claim 8, Mashiach discloses an implant unit 110; an external device 120 in communication with the implant unit 110 (par. [0116]; Fig. 1) and a motion sensing unit (circuit for monitoring the degree of coupling of two antennas that are a proxy measure of motion of the tongue (par. [0216]).
Regarding Claim 9, Mashiach discloses one antenna 150 of the motion sensing unit is associated with the external device 120 and one antenna of the motion sensing unit is associated with the implant 110 (par. [0216]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 6 /are rejected under 35 U.S.C. 103 as being unpatentable over Mashiach et al. (2018/0221657) in view of Meadows et al. (2010/0241195). Mashiach discloses detecting the position of the tongue and controlling stimulation based on degrees of obstruction cause by the tongue. Mashiach is silent regarding the use of an accelerometer as the particular tracking sensor. However, Meadows, in the same field of endeavor of apnea treatment, discloses that an accelerometer can be used for the purpose of tracking tongue movement in conjunction with other sensors (par. [0155-0158]). This provides the benefit of accurate apnea detection and more fine-tuned control over applied stimuli. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Mashiach reference to include an accelerometer, as taught and suggested by Meadows, for the purpose of accurately tracking tongue position in a multi-sensor embodiment and thus more accurately identifying specific tongue positions.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Applicant’s amendment creates new combinations of features in claims 1, 5 and 6 not previously claimed. 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.
/ALLEN PORTER/Primary Examiner, Art Unit 3796
