DETAILED ACTION
This action is in response to the amendment filed 10/21/2025. Currently, claims 1, 2, 4-8 and 10-16 are pending in the application. Claims 3, 9 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 Claims 13 and 14 are withdrawn and not examined at this point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 .
Response to Arguments
Applicant’s amendments to the claims and the drawings are not wholly sufficient to overcome the previous objection to the drawings. The drawings, therefore, remain objected to for the reason(s) below.
Applicant’s amendment to the specification is sufficient to overcome the previous objection to claim 1. Applicant’s amendment to claim 5 is sufficient to overcome the previous objection to claim 5. Applicant’s amendment to claim 12 is sufficient to overcome the previous objection to claim 12.
Applicant’s amendment to claim 1 is sufficient to overcome the previous rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 6 is sufficient to overcome the previous rejection of claim 6 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 7 is sufficient to overcome the previous rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 8 is sufficient to overcome the previous rejection of claim 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 10 is sufficient to overcome the previous rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 12 is sufficient to overcome the previous rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 15 is sufficient to overcome the previous rejection of claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 16 is sufficient to overcome the previous rejection of claim 16 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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, the 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 (see claim 4) and the mandibular fastener sized and configured to anchor to a mandible of the patient; and a sixth elastic or a sixth static member disposed between the mandibular fastener and the hyoid bone fastener; a tongue fastener sized and configured to anchor to a tongue of the patient; and a seventh elastic or a seventh static member disposed between the [same] mandibular fastener and the tongue fastener (see claim 12) 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.
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 § 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.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 12 recites “a sixth elastic member or a sixth static member.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach the hyolaryngeal suspension system including six elastic or static members, as claimed. Applicant’s original disclosure teaches the system including a total of five elastic or static members.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 12 recites “a seventh elastic member or a seventh static member.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach the hyolaryngeal suspension system including seven elastic or static members, as claimed. Applicant’s original disclosure teaches the system including a total of five elastic or static members.
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.
Claim(s) 1, 2, 6, 7, 8, 10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Atkinson et al. (US 7,644,714).
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 elastic or a first static member (tension member 84; capable of remaining in a static position when the user is not moving) 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), the first 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 first static member (tension member 84; 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 84 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), 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).
In regards to claim 2, Atkinson et al. teaches 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. teaches 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. teaches 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. teaches 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. teaches 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 12, Atkinson et al. teaches 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 fifth elastic or a fifth 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 hyoid bone fastener (top anchor of tension member 86) and 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) or disposed between the hyoid bone fastener and the inferior bone fastener sized and configured to anchor to an anatomical bony structure inferior to the thyroid cartilage of the patient; a mandibular fastener (top anchor of tension member 82) sized and configured to anchor to a mandible (mandible M) of the patient (Figure 8J teaches the top anchor of tension member 82 being anchored to the mandible M); and a sixth elastic or a sixth static member (tension member 82; 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 82) and the hyoid bone fastener (top anchor of tension member 86); a tongue fastener (top anchor of tension member 80) sized and configured to anchor to a tongue of the patient (top anchor of tension member 80 is capable of being anchored to a tongue); and a seventh elastic or a seventh static member (tension member 80) disposed between (Figure 8J teaches that the tension member 80 would be positioned between the top anchor of tension member 82 and the top anchor of tension member 80, when the top anchor of tension member 80 is anchored to the tongue) the mandibular fastener (top anchor of tension member 82) and the tongue fastener (top anchor of tension member 80), wherein all of the elastic members have sufficient elasticity to allow the pharynx and/or the larynx to elevate to permit speech and swallowing by the patient (note: claims 1 and 12 require elastic or static members and therefore, the elastic members are not required by the claims), and wherein all of the static members having sufficient tension to maintain pharyngeal wall tension while still permitting sufficient movement of the hyoid bone and thyroid cartilage to permit speech and swallowing by the patient (all of the static members are capable of maintaining pharyngeal wall tension while still permitting sufficient movement of the hyoid bone and thyroid cartilage to permit speech and swallowing by the patient, depending on the anatomy of the user).
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) 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 Bashyam (US 2014/0135868).
In regards to claim 4, Atkinson et al. teaches the apparatus of claim 1. Atkinson et al. does 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. 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. 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. 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 Bashyam (US 2014/0135868) and further in view of Ludlow et al. (US 8,579,839).
In regards to claim 5, Atkinson et al. and Bashyam teach the apparatus of claims 1 and 4. Atkinson 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 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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Atkinson et al. (US 7,644,714).
In regards to claim 11, Atkinson et al. teaches the apparatus of claim 1. The originally relied upon embodiment of Atkinson et al. does 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. 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.
Conclusion
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 2/9/2026