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 .
Status of claim(s)
Claims 1-20 have been examined. Claims 1-5, 10-14 have been amended.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (US10111729B1 hereinafter Lowe) in view of Bergersen (US11369458B1)
With respect to claim 1, Lowe teaches a method for treating an orofacial muscle disorder in a patient, the method comprising:
modifying a first component comprising at least one of an airway, an airway including a nasal cavity, an oral cavity, an upper and lower airway, an upper airway of the patient with a removable oral appliance configured to promote bone growth and photobiomodulation and to at least one of increase a size or change a shape of the upper airway (‘729; Abstract: by disclosure, Lowe describes use of removable orthodontic appliances coupled with night time use of accelerated orthodontic treatment modalities is provided. Accelerated orthodontic treatment modalities include micropulse vibrations, ultrasound vibrations, photobiomodulation; Col/lines 5/1-13: Lowe further describes use of aligners coupled with micropulse vibration will activate osteoblast activity, as well as increase several bone growth biomarkers. ); and
Bergersenteaches
exercising a second component comprising orofacial muscles including at least a genioglossus muscle and an orbicularis oris muscle with at least one orofacial myofunctional therapy exercise performed in a multi-phase orofacial myofunctional therapy program while the patient is concurrently using the removable oral appliance (‘458; Col/lines 4/23-36: Bergersen discloses the vibrating device contacts and vibrates all of these muscles via the outer margins of the appliances that can increase the blood flow and oxygen to these muscles. These muscles are those that influence in keeping the mandible in a closed position (masseter), in a forward position (internal and external pterygoids), keeps the tongue in a forward position (genioglossus), keeps the tongue elevated (glossopalatinus), and keeps the lips closed and to lengthen the lips (orbicularis oris). This also has the ability to strengthen the lips to aid in keeping the appliance in the mouth. These are the same muscles that are used in various exercises recommended when using the Habit Corrector as well as in the use of the C, IG, G, and N as well as by myofunctional therapists.).
It would have been obvious to one of ordinary skill in the art before the effective filing of claimed invention to combine night time orthodontics of Lowe and customized guidance appliances of Bergersen in order to provide the application of removable oral appliance with photobiomodulation therapy to patient.
Claim 14 is rejected as the same reason with claim 1.
With respect to claim 2, the combined art teaches the method of claim 1, wherein the first component of the oral anatomy of the patient is selected from the group consisting of an airway, an airway including a nasal cavity, an oral cavity, and an upper and lower airway, an upper airway, a tooth position, a jaw position, an upper jaw position, a lower jaw position, a tongue position, a lip position, a bite, a component relating to breathing, a component relating to posture, a component relating to speech, a component relating to sleep disordered breathing symptoms, and combinations thereof the removable oral appliance is configured to promote bone growth and photobiomodulation in an upper airway and to reposition one or both of the jaws to increase airflow. (‘458; Abstract)
With respect to claim 3, the combined art teaches the method of claim 1, wherein modifying comprises photobiomodulation to stimulate tissue remodeling that increases a minimal cross-sectional dimension of the upper airway (‘458; Abstract).
With respect to claim 4, the combined art teaches the method of claim 1, wherein in the multi-phase program is performed concurrently with nightly use of the removable oral appliance. (‘729; Abstract: Night time use of removable orthodontic appliances coupled with night time use of accelerated orthodontic treatment modalities is provided).
With respect to claim 5, the combined art teaches the method of claim 1, wherein the removable oral appliance comprises an oral appliance configured to emit infrared light for photobiomodulation to promote bone growth while worn by the patient. (‘729; Abstract; Col/lines 5/1-3: nighttime use of aligners coupled with micropulse vibration will activate osteoblast activity , as well as increase several bone growth biomarkers)
With respect to claim 6, the combined art teaches the method of claim 1, wherein the second component of the oral anatomy of the patient comprises using at least one tool to perform the at least one orofacial myofunctional therapy exercise (‘458; Col/lines 17/43-45)
With respect to claim 7, the combined art teaches the method of claim 1, wherein exercising the second component of the oral anatomy of the patient comprises exercising the second component of the oral anatomy of the patient with at least one orofacial myofunctional therapy exercise in a multi-phase orofacial myofunctional therapy program. (‘458; Abstract)
With respect to claim 8, the combined art teaches the method of claim 1, further comprising providing the patient with the oral appliance (‘458; Abstract).
With respect to claim 9, the combined art teaches the method of claim 1, further comprising providing the patient with instructions to perform the at least one orofacial myofunctional therapy exercise (‘458; Abstract: and tissues in and around the oral cavity of the individual . The preformed guidance appliance driven by the pulsation device is selected from a range of guidance appliances , each of which is selected by size and shape to fit an individual based on the individuals anticipated tooth and jaw size as well as the growth profile).
With respect to claim 10, the combined art teaches the method of claim 4, wherein the method increases the size of the airway of the patient and/or changes the shape of the airway of the patient, and further trains the patient on how to use the increased the size of the airway and/or the changed shape of the airway (‘458; Col/lines 15/45-57: The use of the device 10 provides , but is not limited to 45 appliances ) and aids in the distalization of the mandibular providing , the following advantages : 1 ) increasing the effi- ciency of training muscles to correct mouth breathing ; 2 ) increasing the efficiency of training muscles to train the tongue to be positioned within the palate during resting dentition ( Class III appliances ) as well as reduction in lower face prominence . The introduction of pulsation in combination with a specially designed habit and abnormal sleep correction posture :).
With respect to claim 11, the combined art teaches the method of claim 4, wherein the second component of the oral anatomy of the patient is selected from the group consisting of head posture, resting tongue position, tongue strength, breathing patterns, oral noxious habits, functional frenuloplasty, range of motion, tongue range of motion, elasticity in facial muscles, speech psychological associations thereof, and combinations thereof (‘458; Col/lines 17/1-30;mouthe breathing, increase tongue strength, etc…).
With respect to claim 12, the combined art teaches the method of claim 4, wherein the second component of the oral anatomy of the patient is selected from the group consisting of head muscles, head airways, face muscles, face tissues, nasal muscles, nasal tissues, tongue muscles, tongue tissues, throat muscles, throat tissues, lip muscles, lip tissues, cheek muscles, cheek tissues, jaw muscles, jaw tissues, and combinations thereof (‘458; Col/lines 4/5-22).
With respect to claim 13, the combined art l teaches the method of claim 4, wherein the second component of the oral anatomy of the patient is selected from the group consisting of orofacial muscles, cranial muscles, neck muscles, a genioglossus muscle, a styloglossus muscles, a hyoglossus muscle, a palatoglossus muscle, a lateral-pterygoid muscle, a masseter muscle, a superficial masseter muscle, a platysma muscles, an orbicularis muscle, a levator labii superiois muscle, a risorius muscle, a zygomaticus major muscle, a zygomaticus minor muscle, a zygomaticus muscle, a depressor anguli oris muscle, a depressor labii inferioris muscle, a mentalist muscle, a superior lingualis muscle, an inferior lingualis muscle, a vertical lingualis muscle, a transverse lingualis muscle, a buccinator muscle, and combinations thereof (‘458; Col/lines 17/1-45: genioglossus muscle, masseter muscles:).
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe et al. (US10111729B1 hereinafter Lowe) in view of Bergersen (US11369458B1) and further in view of Ward et al. (US20220401679A1 hereinafter Ward).
With respect to claim 15, the combined art does not each, according to the system of claim 14, wherein the instructions are in a form selected from the group consisting of written instructions, electronic instructions, and combinations thereof. However, Ward discloses the aforementioned feature (679; Para 0025, Para 0029).
It would have been obvious to one or ordinary skill in the art before the effective filing date of claimed invention to modify the oral appliance of Lowe/Bergersen with the myofunctional training of Ward in order to provide instruction for performing the orofacial myofunctional therapy
With respect to claim 16, the combined art does not teach, according to the system of claim 14, further comprising a non-transitory computer-readable storage medium having computer-executable instructions embodied thereon, wherein when executed by a computing device including at least one processor in communication with a memory, the computer-readable instructions cause the computing device to provide the patient with the instructions for performing at least one orofacial myofunctional therapy exercise. However, Ward discloses the aforementioned feature (679; Para 0025, Para 0029).
It would have been obvious to one or ordinary skill in the art before the effective filing date of claimed invention to modify the oral appliance of Lowe/Bergersen with the myofunctional training of Ward in order to provide instruction for performing the orofacial myofunctional therapy
With respect to claim 17, the combined art does not teach, according to the system of claim 14, further comprising a computing device comprising: a memory; and a processor communicatively coupled to the memory, the processor programmed to provide the patient with the instructions for performing at least one orofacial myofunctional therapy exercise. However, Ward discloses the aforementioned feature (679; Para 0025, Para 0029).
It would have been obvious to one or ordinary skill in the art before the effective filing date of claimed invention to modify the oral appliance of Lowe/Bergersen with the myofunctional training of Ward in order to provide instruction for performing the orofacial myofunctional therapy
Claim 18 is rejected as the same reason with claim 1,
Ward further teaches a non-transitory computer-readable storage medium having computer-executable instructions embodied thereon for treating an orofacial muscle disorder in a patient (‘679; Para 0025), wherein the computing device is configured to be used in conjunction with an oral appliance configured to
wherein when executed by a computing device including at least one processor in communication with a memory, the computer-readable instructions cause the computing device to:
provide the patient with instructions for performing the at least one orofacial myofunctional therapy exercise to exercise a second component of the oral anatomy of the patient (‘679; Para 0029: The computer 100 in some embodiments can include a variety of sensors 165 for monitoring the environment surrounding and the environment internal to the computer 100. Additionally, computer 100 may include a variety of sensors 165 for monitoring a human subject. These sensors 165 can include a Global Positioning System (GPS) sensor, a photosensitive sensor, a gyroscope, a magnetometer, thermometer, a proximity sensor, an accelerometer, a microphone, biometric sensor, barometer, humidity sensor, radiation sensor, or any other suitable sensor. In some embodiments, computer 100 may connect to and control a pump for moving breathable air. In some embodiments, computer 100 may connect to and control a motor for moving breathable air. For example, computer 100 may connect to and control a vacuum pump and connect to and receive a signal from a pressure transducer, a manometer and a pneumotachograph, as further elaborated upon below. Myofunctional Training with Negative Airway Pressure for Obstructive Sleep Apnea)
It would have been obvious to one or ordinary skill in the art before the effective filing date of claimed invention to modify the oral appliance of Lowe/Bergersen with the myofunctional training of Ward in order to provide instruction for performing the orofacial myofunctional therapy
With respect to claim 19, the combined art teaches the non-transitory computer-readable storage medium according to claim 18, wherein the computer-readable instructions further cause the computing device to cause a user interface on a mobile computing device to display feedback regarding the at least one orofacial myofunctional therapy exercise (‘679; Para 0028).
With respect to claim 20, the combined art teaches the non-transitory computer-readable storage medium according to claim 18, wherein the computer-readable instructions further cause the computing device to: receive input from the patient; provide a healthcare professional with input from the patient; receive input from the healthcare professional; provide the patient with input from the healthcare professional; facilitate communication between the patient and the healthcare professional; facilitate communication between a guardian of the patient and the healthcare professional; facilitate communication between a guardian of multiple patients and the healthcare professional; facilitate communication and/or collaboration between a first healthcare professional and at least one other healthcare professional; facilitate communication between the patient and a technical support professional; facilitate communication between a guardian of the patient and a technical support professional; facilitate communication between a guardian of multiple patients and a technical support pr fessional; facilitate communication between a healthcare professional and a technical support professional; allow the patient to register for an educational service; allow a healthcare professional to register for an educational service; provide the patient with at least one educational resource; output an animation; output a gamification component; store data and/or information; and/or monitor progress of the patient (‘679; Para 0027).
Response to Arguments
Applicant’s arguments, see Remark, filed 02//27/2026, with respect to the rejection(s) of claim(s) 1-20 under 35USC102 and 35USC103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made of Lowe reference in view of Bergersen.
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.
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686