DETAILED ACTION
This action is in response to the amendment filed 11/14/2025. Currently, claims 1-10 and 12-21 are pending in the application. Claim 11 is cancelled by Applicant. Claims 2, 10, 14 and 19 are withdrawn and not examined at this point. New claim 21 is added by Applicant.
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 drawings fail to overcome all previous objections to the drawings. Further, Applicant failed to provide arguments drawn to the outstanding objections to the drawings. The drawings, therefore, remain objected to as detailed below.
Applicant’s amendment to claim 1 is sufficient to overcome the previous objections to claim 1. Applicant’s amendments to claims 3 and 20 are sufficient to overcome the previous objection to claim 3 and 20. Applicant’s amendment to claim 12 is sufficient to overcome the previous objection to claim 12. Applicant’s amendment to claim 13 is sufficient to overcome the previous objections to claim 13. Applicant’s amendment to claim 18 is sufficient to overcome the previous objection to claim 18.
Applicant’s amendment to claim 5 is sufficient to overcome the previous rejections of claim 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 9 is sufficient to overcome the previous rejection of claim 9 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 claims 12 and 13 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 claims 15-18 and 20 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 rejections of claims 12 and 13 under 35 U.S.C. 101 and section 33(a) of the America Invents Act.
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Applicant’s arguments that the previously cited prior art does not teach that the apex of the fin-shaped body is positioned more posterior than the posterior surface of the mandibular tooth covering have been fully considered and are persuasive. However, upon further consideration and in view of Applicant’s amendment, new ground(s) of rejection are made in view of Razmovski (US 2010/0043804 A1) and Herron et al. (US 2021/0113832 A1).
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, claim external controller (see claim 13) 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 amendment to the drawings filed 11/14/2025 introduces new matter into the disclosure. Amended Figure 8 introduces a specific location of an electrode 301a within the fin-shaped body 106, which was not taught in Applicant’s application as originally filed. 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.
Specification
The amendment filed 11/14/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: “electrode 310, 310a.” Applicant’s original disclosure does not teach the device including two electrodes, as indicated by the “electrode 310, 310a” having two distinct reference characters. Applicant’s original disclosure explicitly teaches “the oral activity active element 310 may be a sensor, an electrode, or other electronics” (see [0050] of the publication of the present application), indicating that only a single electrode is present.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 9 is objected to because of the following informalities: in order to correct a typographical/grammatical error, “to so that” in line 2 of the claim should be amended to recite ---so that---. Appropriate correction is required.
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, 3-5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garner (US 2019/0374734 A1) in view of Razmovski (US 2010/0043804 A1).
In regards to claim 1, Garner teaches in Figures 1A-3C, [0064-0065], [0067], [0069] and [0108] a mandibular tooth covering (dental appliance 10; [0069] teaches “dental appliance 10 received in the mouth and engaged with the mandibular teeth 105 of the user;” also shown in Figure 2) having ([0064] teaches “flanges 90, 92 extend forth mesially from lingual side 14 of dental appliance”) a lingual flange (flanges 90, 92; [0065] teaches “flanges 90, 92 extend mesially a distance sufficient to impinge upon the side of the tongue”) extending caudally from a medial surface (mesial surface) or posterior surface thereof (as shown in Figures 1A-2, flanges 90, 92 extend rearwardly along a medial surface of dental appliance 10; [0064] teaches “flanges 90, 92 extend forth mesially from lingual side 14 of dental appliance generally along the straight portions of the “U,” as illustrated in FIGS. 1A, 1B and 1C,” “flange 90 extends mesially from body 20” and “flange 92 extends mesially from body 22”);
wherein the lingual flange (flanges 90, 92) has a fin-shaped body (Figures 1A-2 teach the flanges 90, 92 being shaped like a fin) that curves posteriorly as it extends caudally (Figures 1A-2 teach the edges 91, 93 of the flanges 90, 92 being curved in the rearward direction) to position an apex (apexes of the most rearward arches on edges 91, 93 of flanges 90, 92) thereof and the fin-shaped body (flanges 90, 92) has a medial surface having a shape that is contoured to seat under the user's tongue in contact with the user’s tongue, hyoglossus muscle, and genioglossus muscle (flanges 90, 92 have a medial surface that is contoured such that it is capable of being positioned under a user's tongue in contact with the tongue, hyoglossus muscle, and genioglossus muscle; [0067] teaches “flanges 90, 92 are exemplary, and flange as used herein may include protuberances, extensions, or structures that extend forth from the lingual side of the dental appliance and are configured to touch the tongue in order to stimulate the hypoglossal nerve of the tongue, for example, by compression of the genioglossus including other muscles or tissues of the tongue,” and “edges 91, 93 are exemplary, and edge as used herein may include portions of the flange that generally contact the tongue to stimulate the hypoglossal nerve”), thereby simultaneously lifting the user’s tongue and antero-cranially advancing the user’s hyoid bone ([0108] teaches “flanges 74, 90, 92, 290, 292, 432, 442, 462, 472, 482, may be disposed in various ways about the dental appliance, for example, to stimulate the hypoglossal nerve of the tongue at various locations by contacting the tongue in order to prompt forward contraction of the genioglossus, in various implementations;” forward contraction of the genioglossus muscle would necessarily result in forward movement of the hyoid bone that is attached thereto).
Garner does not teach that the apex of the fin-shaped body is positioned more posterior than the posterior surface of the mandibular tooth covering.
However, Razmovski teaches in Figure 2, [0051] and [0053] an analogous device wherein the apex (cradle members 14 and 14a) of the fin-shaped body (flanges 12 and 12a; [0053] teaches “the flanges 12 and 12a form a longitudinal shoulder 13 and 13a ending in cradle members 14 and 14a respectively”) is positioned more posterior than (as shown in Figure 2) the posterior surface of (most rearward edge of) the mandibular tooth covering (teeth engaging members 2, 3; [0051] teaches “a pair of oppositely disposed teeth engaging elements/appliances 2 and 3 adapted to be located on or over the teeth on opposite sides of the mandibular dental arches”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apex of the fin-shaped body of Garner to be positioned more posterior than the posterior surface of the mandibular tooth covering as taught by Razmovski because this element is known to provide that the user’s tongue “is additionally supported,” as Razmovski teaches in [0053].
In regards to claim 3, Garner and Razmovski teach the apparatus of claim 1. Garner teaches in Figures 1A-2 and [0065] dual lingual flanges (flanges 90, 92; [0065] teaches “flanges 90, 92 extend mesially a distance sufficient to impinge upon the side of the tongue”), one (flange 92) extending from (as shown in Figures 1A-2) the medial surface of the mandibular tooth covering (dental appliance 10) proximate a left molar portion (occlusal pad 42) and another (flange 90) extending from (as shown in Figures 1A-2) the medial surface proximate a right molar portion (occlusal pad 40) of the mandibular tooth covering (dental appliance 10).
In regards to claim 4, Garner and Razmovski teach the apparatus of claim 1. Garner teaches in Figures 1A-2 that the fin-shaped body (Figures 1A-2 teach the flanges 90, 92 being shaped like a fin) is angled medially inward as it extends caudally (Figures 1A-2 teaches the flanges 90, 92 being angled medially inwardly to form apexes in edges 91, 93, with the edges 91, 93 angling toward the apexes as you move rearwardly along the flanges 90, 92).
In regards to claim 5, Garner and Razmovski teach the apparatus of claims 1 and 4. Garner teaches in Figures 1A-2 that a lateral surface (edges 91, 93) of the fin-shaped body (Figures 1A-2 teach the flanges 90, 92 being shaped like a fin) is spaced a distance medially away from (as shown in Figures 1A-2) a molar portion (occlusal pads 40, 42) of the mandibular tooth covering (dental appliance 10).
In regards to claim 7, Garner and Razmovski teach the apparatus of claim 1. Garner teaches in Figures 1A-2 that the apex (apexes of the most rearward arches on edges 91, 93 of flanges 90, 92) is a rounded tip (Figures 1A-2 teach the apexes of the most rearward arches on edges 91, 93 of flanges 90, 92 being rounded).
In regards to claim 8, Garner and Razmovski teach the apparatus of claims 1 and 7. Garner teaches in Figures 1A-2 that the rounded tip (Figures 1A-2 teach the apexes of the most rearward arches on edges 91, 93 of flanges 90, 92 being rounded) is convex medially, laterally, anteriorly, and posteriorly (Figures 1A-2 teaches the rounded tip being convex on all sides of edges 91, 93).
In regards to claim 9, Garner and Razmovski teach the apparatus of claim 1. Garner teaches in Figures 1A-2 and [0065] that the lingual flange (flanges 90, 92) of the mandibular tooth covering (dental appliance 10) comprises a plurality of lingual flanges (flanges 90, 92) positioned to so that a right lingual flange (flange 90; [0065] teaches “flanges 90, 92 extend mesially a distance sufficient to impinge upon the side of the tongue”) and a left lingual flange (flange 92; [0065] teaches “flanges 90, 92 extend mesially a distance sufficient to impinge upon the side of the tongue”) are present (as shown in Figures 1A-2).
Claim(s) 1, 15-18, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghuge (US 2021/0145630 A1) in view of Herron et al. (US 2021/0113832 A1).
In regards to claim 1, Ghuge teaches in Figures 1 and 4, [0044] and [0070-0071]
a mandibular tooth covering (mandibular piece 104; [0044] teaches “the mandibular piece 104 is shown, which has a first teeth covering 106”) having a lingual flange (stimulator 116; shown in Figure 1 to be positioned to engage a user’s tongue in use; [0044] teaches “stimulator 116 extends from each housing 108 toward the tongue at a position to lie under the tongue in contact with lingual muscles, in particular the Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP)”) extending caudally from a medial surface (Figure 1 teaches the stimulator 116 having a depth that extends rearwardly from a medial surface of the mandibular piece 104) or posterior surface thereof;
wherein the lingual flange (stimulator 116) has a fin-shaped body (Figure 1 teaches the stimulator 116 being shaped like a fin) that curves posteriorly as it extends caudally (Figure 1 teaches the stimulator 116 being curved in the rearward direction) to position an apex (apex of the curved stimulator 116) thereof and the fin-shaped body (stimulator 116) has a medial surface having a shape that is contoured to seat under the user's tongue in contact with the user’s tongue, hyoglossus muscle, and genioglossus muscle ([0044] teaches “stimulator 116 extends from each housing 108 toward the tongue at a position to lie under the tongue in contact with lingual muscles, in particular the Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP)”), thereby simultaneously lifting the user’s tongue ([0044] teaches the stimulator 116 lying under the tongue in use and thus, the stimulator functions to lift the user’s tongue thereabove; [0070] teaches “each stimulator 116 has a single or dual electrode 154 connected to the power source 120 and generates an electrical impulse that travels through the electrode to one or more of the lingual muscles of the tongue identified above, which contracts the lingual muscle(s) to create a forward movement of the tongue;”) and antero-cranially advancing the user’s hyoid bone (forward movement of the tongue would necessarily result in forward movement of the hyoid bone that is attached thereto; [0071] teaches “the forward movement of the mandible (protrusion) is performed by lateral pterygoids, medial pterygoids and masseter muscles” and “the transverse stimulator 116 can specifically target these muscle groups and their distributing nerve and stimulate and sense electrical activity of these various muscles individually or together inside the oral cavity”).
Ghuge does not teach that the apex of the fin-shaped body is positioned more posterior than the posterior surface of the mandibular tooth covering.
However, Herron et al. teaches in Figures 16-19 an analogous device wherein the apex (as defined in the annotated copy of Figure 17 provided below) of the fin-shaped body (extensions 6040a and 6040b) is positioned more posterior than (as shown in Figure 17) the posterior surface (as defined in the annotated copy of Figure 17 provided below) of the mandibular tooth covering (intraoral appliance 6000; shown in Figures 16-19 to be configured to be positioned over the user’s mandibular dentition).
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It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apex of the fin-shaped body of Ghuge to be positioned more posterior than the posterior surface of the mandibular tooth covering as taught by Herron et al. because this element is known to moveably position the electrodes positioned thereon in a manner that accommodates movement of the tongue while swallowing, etc., while maintaining electrical contact with the target tissue to deliver therapeutic electrical stimulation, “to position electrodes adjacent to and/or in electrical contact with specific locations or anatomical structures in a patient's oral cavity while permitting controlled flexibility and movement” and to most appropriately position the electrodes for a patient that is lying on his or her back, wherein the tongue may move back in a subject's oral cavity in this position, as Herron et al. teaches in [0076], [0085] and [0125].
In regards to claim 15, Ghuge teaches in Figures 1 and 4, [0015], [0044] and [0067] identifying a user in need of an increased area for their smallest cross-sectional area of their upper airway ([0067] teaches “a user in need of an open airway, most often during sleep, but not limited thereto, inserts the maxillary and mandibular device of any of the embodiments disclosed herein into their mouth and goes about with their activity or goes to sleep”); fitting a mandibular apparatus according to claim 1 (Ghuge and Herron et al. teach the apparatus of claim 1, as detailed in the rejection of claim 1 above) to the user's teeth ([0015] teaches “the tooth covering of each of the maxillary piece and the mandibular piece connects to or covers one or more teeth of a user”; [0067] teaches “a user in need of an open airway, most often during sleep, but not limited thereto, inserts the maxillary and mandibular device of any of the embodiments disclosed herein into their mouth”), postero-ventral surface of the user's tongue ([0044] teaches “a stimulator 116 extends from each housing 108 toward the tongue at a position to lie under the tongue in contact with lingual muscles, in particular the Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP)” and “each stimulator portion 116 while appearing somewhat boxy-looking in the drawings, is more preferably molded of moldable material suitable for use in a human oral cavity and has smooth transitions to its shape and is shaped to match the shape of the user's mouth, especially to sit under the tongue in contact with the base of the tong”), genioglossus muscle ([0044] teaches “a stimulator 116 extends from each housing 108 toward the tongue at a position to lie under the tongue in contact with lingual muscles, in particular the Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP)”), and hyoglossus muscle ([0044] teaches “a stimulator 116 extends from each housing 108 toward the tongue at a position to lie under the tongue in contact with lingual muscles, in particular the Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP);” since the hyoglossus muscle is an extrinsic muscle of the tongue and located on the floor of the oral cavity, the device necessarily comes in contact with hyoglossus muscle); and providing the mandibular apparatus thus fitted to the user ([0067] teaches “a user in need of an open airway, most often during sleep, but not limited thereto, inserts the maxillary and mandibular device of any of the embodiments disclosed herein into their mouth and goes about with their activity or goes to sleep;” [0044] teaches “the stimulator protrusion 116 of each housing 108 should be fitted to the user/custom made for the user to ensure proper contact with the lingual muscles”).
In regards to claim 16, Ghuge and Herron et al. teach the method of claim 15. Ghuge teaches in [0124] and [0132] instructing the user to wear the mandibular apparatus (mandibular lingual repositioning device 100) while awake ([0124] teaches “the system 300 [which includes mandibular lingual repositioning device 100] may be used to diagnose any possible medical conditions related to sleep or while awake;” [0132] teaches “data from these sensors will allow determination of performance restrictions and methods to physiologically improve performance such as legal nutritional supplementation or medications for underlying medical conditions or increasing the size of airway to help improve oxygenation and reduce heart rate during exercise or athletic performance;” this requires that the user was instructed to wear the mandibular lingual repositioning device 100 while awake).
In regards to claim 17, Ghuge and Herron et al. teach the method of claims 15 and 16. Ghuge teaches in [0072] and [0132] instructing the user to wear the mandibular apparatus (mandibular lingual repositioning device 100) during exercise ([0132] teaches “data from these sensors will allow determination of performance restrictions and methods to physiologically improve performance such as legal nutritional supplementation or medications for underlying medical conditions or increasing the size of airway to help improve oxygenation and reduce heart rate during exercise or athletic performance;” this requires that the user was instructed to wear the mandibular lingual repositioning device 100 during exercise; [0072] teaches “Also, the stimulators 116 can stimulate selected muscles to improve their strength. This can be a training or a retraining exercise, for example, after a stroke (swallowing difficulty or speech difficulty) or for children with speech pathologies.”).
In regards to claim 18, Ghuge and Herron et al. teach the method of claim 15. Ghuge teaches in [0005], [0067], [0130] and [0133] instructing the user to wear the mandibular apparatus (mandibular lingual repositioning device 100) during sleep ([0005] teaches “a device that can continuously learn (artificial intelligence) a particular persons sleep-related breathing, blood pressure, heart rate and rhythm, body positioning, depth of sleep and oxygen levels, silent or symptomatic acid reflux during sleep and amount of bruxism (teeth grinding) over periods of days, months and even years while the person sleeps at home or elsewhere, thereby removing the need of performing expensive sleep studies;” [0067] teaches “a user in need of an open airway, most often during sleep, but not limited thereto, inserts the maxillary and mandibular device of any of the embodiments disclosed herein into their mouth and goes about with their activity or goes to sleep;” [0130] teaches “the devices disclosed herein are worn by a user at nighttime and includes sensors to monitor nocturnal silent angina or myocardial ischemia (measured by continuous EKG monitoring) that could cause sudden death or acute myocardial infarction during sleep or wake (especially silent ischemia);” [0133] teaches “system 300 [which includes mandibular lingual repositioning device 100] can be used for scheduled timed administration of medication through the mechanisms and devices discussed above, especially for those medications best administered while the user is asleep;” this requires that the user was instructed to wear the mandibular lingual repositioning device 100 while sleeping).
In regards to claim 20, Ghuge and Herron et al. teach the method of claim 15. Ghuge teaches in Figure 1 dual lingual flanges (first and second stimulators 116; shown in Figure 1 to be positioned to engage a user’s tongue in use; [0044] teaches “stimulator 116 extends from each housing 108 toward the tongue at a position to lie under the tongue in contact with lingual muscles, in particular the Genioglossus (GG), the Geniohyoid (GH), sub-mentalis (SM), and Glossopharyngeal (GP)”), one extending from the medial surface of the mandibular tooth covering (mandibular piece 104) proximate (as shown in Figure 1) a left molar portion (left molar portion 110) and another extending from the medial surface proximate (as shown in Figure 1) a right molar portion (right molar portion 112) of the mandibular tooth covering (mandibular piece 104; [0044] teaches “the mandibular piece 104 is shown, which has a first teeth covering 106”).
In regards to claim 21, Ghuge and Herron et al. teach the apparatus of claim 15. Ghuge does not teach that a posterior surface of the lingual flange is generally convex cranially and transitions to concave caudally therefrom until it convexly forms the apex.
However, Herron et al. teaches in Figures 16-19 an analogous device wherein a posterior surface of (most rearward surface of) the lingual flange (extensions 6040a and 6040b) is generally convex cranially (as noted in the annotated copy of Figure 17 provided below) and transitions to concave (at posterior bend 6044) caudally therefrom until it convexly forms the apex (as noted in the annotated copy of Figure 17 provided below).
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It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the posterior surface of the lingual flange of Ghuge as modified by Herron et al. such that it is generally convex cranially and transitions to concave caudally therefrom until it convexly forms the apex as taught by Herron et al. because this element is known “to provide flexion points, segments, regions, portions, areas, locations, and/or areas that provide stress relief and allow controlled movement,” as Herron et al. teaches in [0134].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garner (US 2019/0374734 A1), in view of Razmovski (US 2010/0043804 A1) and further in view of Sama (US 2020/0164205 A1).
In regards to claim 6, Garner and Razmovski teach the apparatus of claims 1 and 4. Garner does not teach that the medial surface of the fin-shaped body is generally convex along the length thereof.
However, Sama teaches in Figure 10 an analogous device wherein the medial surface of the fin-shaped body (first and second contact flanges 132, 133) is generally convex along the length thereof (as shown in Figure 10).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the medial surface of the fin-shaped body of Garner as modified by Razmovski to be generally convex along the length thereof as taught by Sama because this element is known to enable the fin-shaped body “to form a curved shape for accommodating the sublingual tongue surface” for stimulation thereof, as Sama teaches in [0090] and [0093].
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garner (US 2019/0374734 A1), in view of Razmovski (US 2010/0043804 A1) and further in view of Ghuge (US 2021/0145630 A1).
In regards to claims 12 and 13, Garner and Razmovski teach the apparatus of claim 1. Garner and Razmovski do not teach that the fin-shaped body defines an internal cavity and (a) a sensor is operatively seated within the internal cavity, wherein the sensor is configured to communicate with the user’s oral cavity to measure or sense a variable thereof and/or (b) a muscle stimulator is operatively seated within the internal cavity and is configured to contact the user’s tongue, hyoglossus muscle, genioglossus muscle, or a combination thereof; and comprising an electronic transmitter and an electronic receiver in operative electrical engagement with the sensor and/or the muscle stimulator, wherein the electronic transmitter and the electronic receiver are configured to communicate with an external controller for dynamic operation of the sensor and/or the muscle stimulator.
However, Ghuge teaches in Figures 9, 10 and 12, [0043-0044], [0068-0070], [0082], [0089], [0107] and [0118] an analogous device wherein the fin-shaped body (stimulator 116; shown in Figure 9 to be shaped like a fin) defines an internal cavity (the hollow area of stimulator 116 in which sensors 150, 152 and electrode 154 are positioned, as shown in Figure 10) and (a) a sensor (sensors 150, 152) is operatively seated within (as shown in Figure 4) the internal cavity (the hollow area of stimulator 116 in which sensors 150, 152 and electrode 154 are positioned, as shown in Figure 10), wherein the sensor (sensors 150, 152) is configured to communicate with the user’s oral cavity to measure or sense a variable thereof ([0043] teaches the mandibular lingual repositioning device 100, which includes sensors 150, 152, being positioned in the oral cavity in use; [0068] teaches that the sensors 150, 152 “are selected form the group consisting of a pulse oximetry sensor, a vibration sensor, an airflow sensor, a pH sensor, a combination pulse oximetry/vibration and airflow sensor, an EKG sensor, EEG sensor, EMG sensor, EOG sensor, lactic acid sensor, a pulse transit time (PTT) sensor, an ultrasound sensor (echocardiography), an electro-oculogram sensor, a temperature sensor, a body position or jaw position sensor (such as a potentiometer), an electromyogram sensor, a pressure measurement sensor, a hygrometer sensor, a microphone or sound recording sensor, video recording, and hygroscopic/hydration sensor;” [0082] teaches “In one embodiment, the first sensor 150 is a pulse oxygen sensor continually measuring oxygen data at the base of the tongue and the second sensor 152 is a vibration/air flow sensor measuring snoring, turbulent flow, and vibrations from inside the user's mouth. As noted above with respect to FIG. 4, multiple other sensors and sensor combinations are possible that will provide data to the microprocessor 159.”) and/or (b) a muscle stimulator (electrode 154; [0070] teaches “an electrical impulse that travels through the electrode to one or more of the lingual muscles of the tongue identified above, which contracts the lingual muscle(s) to create a forward movement of the tongue”) is operatively seated within (as shown in Figure 10) the internal cavity (the hollow area of stimulator 116 in which sensors 150, 152 and electrode 154 are positioned, as shown in Figure 10) and is configured to contact with the user’s tongue, hyoglossus muscle, genioglossus muscle, or a combination thereof ([0070] teaches “an electrical impulse that travels through the electrode to one or more of the lingual muscles of the tongue identified”); and comprising an electronic transmitter (circuit board 124; taught in [0082] to be “in operative connection to the power source to be powered and to control activation of the stimulator electrode 154” and thus, the circuit board 124 must transmit energy to activate the stimulator electrode 154) and an electronic receiver (microprocessor 159) in operative electrical engagement with ([0082] teaches “activation of the stimulator electrode 154 in response to data received by the circuit board 124, more particularly, the microprocessor 159, from the first sensor 150 and/or the second sensor 152” and “the microprocessor 159 receives the sensor data”) the sensor (sensors 150, 152) and/or the muscle stimulator (electrode 154), wherein the electronic transmitter (circuit board 124) and the electronic receiver (microprocessor 159) are configured to communicate with an external controller (controller station 200; shown in Figure 12 to be external to device 101) for dynamic operation of ([0107] teaches “controller station 200 is illustrated for operatively controlling any of the mandibular lingual repositioning devices 100, 101 [which include circuit board 124 and microprocessor 159];” [0089] teaches “using the controller station 200 and cloud server of the system 300, it will be possible to receive data regarding the user's input of food and time consumed to act proactively during sleep based on a correlation of digestion time and acid reflux onset;” [0118] teaches “the controller station 200 includes learning algorithms in the memory of the microprocessor that learns a user's sleep patterns and other physiological events and functions during sleep and wake, pathological events and activities during wake and sleep from the data collected over time and creates a “best response” for the simultaneous, independent, or sequential responses exemplified by tensing of the soft palate or Uvula, release of medication or stimulation of the stimulator and activation of the first and second drivers to open the airway or to train muscles of speech, and to synchronize these best responses such as exemplified by certain jaw movements that are associated with particular phases of respiration”) the sensor (sensors 150, 152) and/or the muscle stimulator (electrode 154).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the fin-shaped body of Garner as modified by Razmovski such that it defines an internal cavity and (a) a sensor is operatively seated within the internal cavity, wherein the sensor is configured to communicate with the user’s oral cavity to measure or sense a variable thereof and/or (b) a muscle stimulator is operatively seated within the internal cavity and is configured to contact the user’s tongue, hyoglossus muscle, genioglossus muscle, or a combination thereof; and comprising an electronic transmitter and an electronic receiver in operative electrical engagement with the sensor and/or the muscle stimulator, wherein the electronic transmitter and the electronic receiver are configured to communicate with an external controller for dynamic operation of the sensor and/or the muscle stimulator as taught by Ghuge because this element is known to enable the fin-shaped body to provide stimulation to the tongue as needed “which contracts the lingual muscle(s) to create a forward movement of the tongue,” wherein “forward movement of the tongue increases the cross-sectional open airway diameter in transvers, vertical and antero-posterior dimensions, thus increasing the aggregate volume of open airway and exponentially reducing air-flow resistance,” as Ghuge teaches in [0068-0070].
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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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 3/2/2026