DETAILED ACTION
This action is in response to the Request for Continued Examination (RCE) filed 5/21/2026. Currently, claims 1, 2, 4-8, 10, 11 and 13-16 are pending in the application. Claims 3, 9, 12 and 17 are cancelled by Applicant. Claims 13 and 14 are withdrawn and not examined at this point
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/21/2026 has been entered.
Response to Arguments
Applicant’s amendment to the drawings is not sufficient to overcome all previous objections to the drawings. The drawings, therefore, remain objected to as detailed below.
Applicant’s arguments that Atkinson et al. does not teach the claimed first elastic member have been fully considered and are persuasive. However, upon further consideration and in view of Applicant’s amendment, a new ground(s) of rejection is made in view of Witt et al. (US 2013/0233324 A1).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “42” has been used to designate both the pulse generator (see Figure 3) and the first fastener (see Figure 1). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “36” has been used to designate both the controller (see Figure 3) and one end (see Figure 1). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “12” has been used to designate both the neurostimulator (see Figure 3) and the first fastener (see Figure 1). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “40” has been used to designate both the telemetry module (see Figure 3) and a hyolaryngeal suspension device (see Figure 1). 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “38” has been used to designate both memory (see Figure 3) and an opposing end (see Figure 1). 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. 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.
The drawings are objected to because the amendment to Figure 1 filed 12/20/2024 is not of sufficient quality such that all details in the drawings are reproducible in black and white in the printed patent. See 37 CFR 1.84 for the accepted standards for drawings. 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 § 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, 2, 6, 7, 8, 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (US 7,644,714) in view of Witt et al. (US 2013/0233324 A1).
In regards to claim 1, Atkinson et al. teaches in Figure 8J and column 7, lines 22-27 a thyroid cartilage fastener (top anchor of tension member 84) sized and configured to anchor to a thyroid cartilage of the patient (the top anchor of tension member 84 is capable of being anchored to the thyroid cartilage TH); an inferior bone fastener (bottom anchor of tension member 84) sized and configured to anchor to an anatomical bony structure inferior to the thyroid cartilage (thyroid cartilage TH) of the patient (the bottom anchor of tension member 84 is shown in Figure 8J to be anchored to the clavicle CL, which is an anatomical bony structure positioned below the thyroid cartilage TH; see Figure 8J); and a first member (tension member 84) disposed between (as shown in Figure 8J) the thyroid cartilage fastener (top anchor of tension member 84) and the inferior bone fastener (bottom anchor of tension member 84), wherein the hyolaryngeal suspension system (shown in Figure 8J) provides isolated and sole inferior traction of the thyroid cartilage (tension member 84 is capable of providing isolated and sole inferior traction of the thyroid cartilage TH, depending on the anatomy of the user).
Atkinson et al. does not teach the first member being elastic; the first member having sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient.
However, Witt et al. teaches in [0031], [0073] and Figure 4 an analogous device (shown in Figure 4) with the first member (elastic portion 32) being elastic ([0031] teaches “an elastic portion 32 configured to provide elasticity between the first portion 22 and the second portion 24”); the first elastic member (elastic portion 32) having sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient ([0073] teaches “when extreme forces are applied to the system 20, such as during swallowing, the elastic portion 32 of the connecting portion 28 may extend to accommodate such forces;” thus, the elastic portion 32 is capable of extending to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the first member of Atkinson et al. to provide the first member being elastic; the first member having sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient as taught by Witt et al. because this element is known to enable the first member to extend to accommodate extreme forces, sch as during speech and swallowing, as Witt et al. teaches in [0073].
In regards to claim 2, Atkinson et al. and Witt et al. teach the apparatus of claim 1. Atkinson et al. teaches in Figure 8J that the inferior bone fastener (bottom anchor of tension member 84) is sized and configured to anchor to a sternum, a rib, or a clavicle (the bottom anchor of tension member 84 is shown in Figure 8J to be anchored to the clavicle CL; the bottom anchor of tension member 84 is capable of being anchored to the sternum S or first rib R1).
In regards to claim 6, Atkinson et al. and Witt et al. teach the apparatus of claim 1. Atkinson et al. teaches in Figure 8J a hyoid bone fastener (top anchor of tension member 86) sized and configured to anchor to a hyoid bone (hyoid bone H) of the patient (Figure 8J teaches the top anchor of tension member 86 being anchored to the hyoid bone H); and a second elastic or a second static member (tension member 86; capable of remaining in a static position when the user is not moving) disposed between (as shown in Figure 8J, the tension member 86 would be positioned between the top anchor of tension member 84 and the top anchor of tension member 86 when the top anchor of tension member 84 is anchored to the thyroid cartilage TH) the thyroid cartilage fastener (top anchor of tension member 84; the top anchor of tension member 84 is capable of being anchored to the thyroid cartilage TH) and the hyoid bone fastener (top anchor of tension member 86), the second elastic member having sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient (note: claim 1 requires an elastic or static member and therefore, the elastic member is not required by the claim), and the second static member (tension member 86) having sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone (hyoid bone H) and thyroid cartilage (thyroid cartilage TH) to permit speech and swallowing by the patient (tension member 86 is capable of having sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone H and the thyroid cartilage TH to permit speech and swallowing by the patient, depending on the anatomy of the user).
In regards to claim 7, Atkinson et al. and Witt et al. teach the apparatus of claim 1. Atkinson et al. teaches in Figure 8J a hyoid bone fastener (top anchor of tension member 86) sized and configured to anchor to a hyoid bone (hyoid bone H) of the patient (Figure 8J teaches the top anchor of tension member 86 being anchored to the hyoid bone H); and a third elastic or a third static member (tension member 86; capable of remaining in a static position when the user is not moving) disposed between (as shown in Figure 8J) the hyoid fastener (top anchor of tension member 86) and an inferior bone fastener (bottom anchor of tension member 86) sized and configured to anchor to an anatomical bony structure inferior to the hyoid bone (Figure 8J teaches the bottom anchor of tension member 86 being anchored to the clavicle CL, which is an anatomical bony structured positioned below the hyoid bone H; see Figure 8J), the third elastic member having sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient (note: claims 1 and 7 require an elastic or static member and therefore, the elastic member is not required by the claims), and the third static member (tension member 86; capable of remaining in a static position when the user is not moving) having sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone (hyoid bone H) and thyroid cartilage (thyroid cartilage TH) to permit speech and swallowing by the patient (tension member 86 is capable of having sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone H and the thyroid cartilage TH to permit speech and swallowing by the patient, depending on the anatomy of the user).
In regards to claim 8, Atkinson et al. and Witt et al. teach the apparatus of claim 1. Atkinson et al. teaches in Figure 8J that the inferior bone fastener (bottom anchor of tension member 84) is configured to anchor to a sternum, a rib, or a clavicle (Figure 8J teaches the bottom anchor of tension member 84 being anchored to the clavicle CL; the bottom anchor of tension member 84 is capable of being anchored to the sternum S or first rib R1).
In regards to claim 10, Atkinson et al. and Witt et al. teach the apparatus of claim 1. Atkinson et al. teaches in Figure 8J a mandibular fastener (top anchor of tension member 80) sized and configured to anchor to a mandible (mandible M) of the patient (Figure 8J teaches the top anchor of tension member 80 being anchored to the mandible M); a hyoid bone fastener (bottom anchor of tension member 80) sized and configured to anchor to a hyoid bone (hyoid bone H) of the patient (Figure 8J teaches the bottom anchor of tension member 80 being anchored to the hyoid bone H); and a fourth static or a fourth elastic member (tension member 80; capable of remaining in a static position when the user is not moving) disposed between (as shown in Figure 8J) the mandibular fastener (top anchor of tension member 80) and the hyoid bone fastener (bottom anchor of tension member 80), the fourth elastic member having sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient (note: claims 1 and 10 require an elastic or static member and therefore, the elastic member is not required by the claims), and the fourth static member (tension member 80; capable of remaining in a static position when the user is not moving) having sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone (hyoid bone H) and thyroid cartilage (thyroid cartilage TH) to permit speech and swallowing by the patient (tension member 80 is capable of having sufficient tension to maintain pharyngeal wall tension while still allowing movement of the hyoid bone H and the thyroid cartilage TH to permit speech and swallowing by the patient, depending on the anatomy of the user).
In regards to claim 11, Atkinson et al. and Witt et al. teach the apparatus of claim 1. The originally relied upon embodiment of Atkinson et al. and Witt et al. do not teach a mandibular fastener sized and configured to anchor to a mandible of a patient; a tongue fastener sized and configured to anchor to a tongue of the patient; and an elastic member disposed between the mandibular fastener and the tongue fastener, the elastic member having sufficient elasticity to allow the tongue to move to permit speech and swallowing.
However, Atkinson et al. teaches in Figure 9B and column 8, lines 5-11 an alternate embodiment with a mandibular fastener (first screw 94) sized and configured to anchor to a mandible of a patient (first screw 94 is capable of being anchored to a mandible; column 8, lines 5-6 teaches first screw 94 being “conventionally used to anchor to bone”); a tongue fastener (second screw 94) sized and configured to anchor to a tongue of the patient (second screw 94 is capable of being anchored to a tongue); and an elastic member (elastic member 91) disposed between (as shown in Figure 9B) the mandibular fastener (first screw 94) and the tongue fastener (second screw 94), the elastic member (elastic member 91) having sufficient elasticity to allow the tongue to move to permit speech and swallowing (elastic member 91 is capable of having sufficient elasticity to allow the tongue to move to permit speech and swallowing, depending on the anatomy of the user).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the originally relied upon embodiment of Atkinson et al. as modified by Witt et al. to further include a mandibular fastener sized and configured to anchor to a mandible of a patient; a tongue fastener sized and configured to anchor to a tongue of the patient; and an elastic member disposed between the mandibular fastener and the tongue fastener, the elastic member having sufficient elasticity to allow the tongue to move to permit speech and swallowing as taught by the alternate embodiment of Atkinson et al. because this element is known to provide an additional mechanism to provide supplementary treatment of “sleep disorders such as obstructive sleep apnea, snoring, etc.” that is “under tension only when displaced sufficiently to be concomitant with an apnea or hypoxia event,” as Atkinson et al. teaches in column 1, lines 18-21 and column 7, lines 58-60.
Claim(s) 4, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (US 7,644,714), in view of Witt et al. (US 2013/0233324 A1) and further in view of Bashyam (US 2014/0135868).
In regards to claim 4, Atkinson et al. and Witt et al. teach the apparatus of claim 1. Atkinson et al. and Witt et al. do not teach a neuromodulation system comprising: at least one electrode configured to deliver an electrical signal to a target site comprising an upper airway muscle or a nerve innervating an upper airway muscle to activate an upper airway muscle; and a controller in electrical communication with the electrode and programmed to direct delivery of the electrical signal to the target site to stimulate the upper airway muscle or the nerve innervating the upper airway muscle to activate the upper airway muscle to improve the SDB.
However, Bashyam teaches in the abstract, Figure 9, [0047], [0068-0069] and [0072] an analogous device with a neuromodulation system (“electrical intraoral Stimulator device” taught in [0047]) comprising: at least one electrode (two pairs of electrodes 915) configured to deliver an electrical signal to a target site comprising an upper airway muscle or a nerve innervating an upper airway muscle to activate an upper airway muscle ([0072] teaches the two pairs of electrodes 915 “corresponding to the bilateral electrodes 603 shown in FIGS. 6A, 6B, 6C;” [0068] teaches “the electrodes in bilateral and unilateral stimulation configurations (603 in FIGS. 6A, 6B, 6C) are designed in such a way as to make good contact with the genioglossus muscle underside of the tongue” and “the electrodes are placed in such a way that they can contact the genioglossus muscle uniformly, the idea being to avoid "hot-spot" current densities, increase the surface contact area or reduce the electrode impedance thus resulting in higher signal-to-noise ratio, low exogenous noise signal pickup (which is particularly useful for EMG pickup), and greater stimulation efficiency”); and a controller (Main Micro-Controller 901) in electrical communication with (as shown in Figure 9) the electrode (two pairs of electrodes 915) and programmed to direct delivery of the electrical signal to the target site to stimulate the upper airway muscle or the nerve innervating the upper airway muscle to activate the upper airway muscle to improve the SDB ([0069] teaches “a Main Micro-Controller 901 for controlling most sub-systems;” the abstract teaches “a non-invasive, removable intraoral electrical Stimulator or Pacemaker system and method is described, for electrically-stimulating and re-establishing the tone in the upper pharyngeal dilator muscle, the genioglossus and base-of-tongue muscles, for the treatment of Obstructive Sleep Apnea (OSA) in human adults and young adults”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the device of Atkinson et al. as modified by Witt et al. to further comprise a neuromodulation system comprising: at least one electrode configured to deliver an electrical signal to a target site comprising an upper airway muscle or a nerve innervating an upper airway muscle to activate an upper airway muscle; and a controller in electrical communication with the electrode and programmed to direct delivery of the electrical signal to the target site to stimulate the upper airway muscle or the nerve innervating the upper airway muscle to activate the upper airway muscle to improve the SDB as taught by Bashyam because this element is known to provide an additional mechanism to provide supplementary “treatment of Obstructive Sleep Apnea (OSA),” as Bashyam teaches in the abstract.
In regards to claim 15, Atkinson et al., Witt et al. and Bashyam teach the apparatus of claims 1 and 4. Applicant should note that the recited nerve is not required by the disclosure of claim 4, upon which claim 15 depends. Bashyam teaches that the upper airway muscle is the a genioglossus muscle ([0072] teaches the two pairs of electrodes 915 “corresponding to the bilateral electrodes 603 shown in FIGS. 6A, 6B, 6C;” [0068] teaches “the electrodes in bilateral and unilateral stimulation configurations (603 in FIGS. 6A, 6B, 6C) are designed in such a way as to make good contact with the genioglossus muscle underside of the tongue” and “the electrodes are placed in such a way that they can contact the genioglossus muscle uniformly, the idea being to avoid "hot-spot" current densities, increase the surface contact area or reduce the electrode impedance thus resulting in higher signal-to-noise ratio, low exogenous noise signal pickup (which is particularly useful for EMG pickup), and greater stimulation efficiency”).
In regards to claim 16, Atkinson et al., Witt et al. and Bashyam teach the apparatus of claims 1 and 4. Applicant should note that the recited nerve is not required by the disclosure of claim 4, upon which claim 15 depends.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (US 7,644,714), in view of Witt et al. (US 2013/0233324 A1), in view of Bashyam (US 2014/0135868) and further in view of Ludlow et al. (US 8,579,839).
In regards to claim 5, Atkinson et al., Witt et al. and Bashyam teach the apparatus of claims 1 and 4. Atkinson et al., Witt et al. and Bashyam do not teach that the nerve is the ansa cervicalis and the upper airway muscle is the sternothyroid muscle.
However, Ludlow et al. teaches in column 23, lines 32-40 an analogous device wherein the nerve is the ansa cervicalis (note: claim 4 requires an upper airway muscle or a nerve and therefore, the nerve is not required by the claim) and the upper airway muscle is the sternothyroid muscle (column 23, lines 32-40 teaches electrode stimulation of the sternothyroid muscle).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the upper airway muscle of Atkinson et al. as modified by Witt et al. and Bashyam to be the sternothyroid muscle as taught by Ludlow et al. because this element is known to result “in hyoid lowering,” as Ludlow et al. teaches in column 23, lines 32-40.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 7/9/2026
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