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, 10-12, 14 have been amended.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “performed in a three-phase orofacial myofunctional therapy program including at least an intensive phase, a generalization phase, and a habituation phase”. However, the claims do not provide adequate structure to perform the functions of a three-phase orofacial myofunctional therapy program. The use of the terms “an intensive phase, a generalization phase, and a habituation phase” is not adequate structure for the function and does not provide enough description for one of ordinary skill in the art to understand which phase to be performed the function of a three phase therapy program. Therefore, the claims are indefinite and is rejected under 35 U.S.C 112(b) or pre-AIA 35 U.S.C. 112 second paragraph.
Allowable Subject Matter Over the Prior Art
The primary reason for indicating allowability over the prior art is the inclusions of the following limitations in the combination as recited.
Claim 1 is directed toward 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; and
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 three-phase orofacial myofunctional therapy program including at least an intensive phase, a generalization phase, and a habituation phase while the patient is concurrently using the removable oral appliance.
The closest prior art relates to Lowe et al. (US10111729B1 hereinafter Lowe) in view of Bergersen (US11369458B1) and Ward (US 20220401679A1). Lowe discloses Night time 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, IR light, low-level laser therapy, pulsed EM fields, static magnetic fields, resonance vibrations, indirect electric current, direct electric current, pharmacological accelerators, surgical accelerators, decortication, osteoperforation, alveocentesis, and piezocision. Bergersen discloses a device including one or more preformed or customized eruption guidance appliances placed in an individual's mouth. The preformed appliances are vibrated with a pulsation device to encourage tooth eruption by increasing the force and efficiency of the eruption toward a preferred location and a preferred alignment as well as providing increased blood flow and blood oxygen flow to the muscles and tissues in and around the oral cavity of the individual. Ward discloses a method and apparatus for treating a subject suffering from obstructive sleep apnea (OSA). In one embodiment, the method of the present invention is configured to deliver negative airway pressure to a subject's airway to strengthen the airway muscle tone.
However, the combined art fails to disclose 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 three-phase orofacial myofunctional therapy program including at least an intensive phase, a generalization phase, and a habituation phase while the patient is concurrently using the removable oral appliance.
The NPL “3D Printer-Assisted Layered Fabrication of a Novel Appliance for Oral Myofunctional Therapy and Functional Evaluation of Its Effects on Orofacial Muscles During Wear” discloses balanced function of the orofacial muscles is important for normal occlusion and dentition; however, patients with malocclusion often present with myofunctional disorder (MFD). Myofunctional therapy (MFT) has received much attention as a method for reducing MFD. Moreover, prefabricated functional appliances (PFAs) have been developed as a method to eliminate abnormal muscle pressure and guide the tongue into the correct position. However, PFAs have disadvantages, such as poor intraoral retention, limited usage time due to discomfort and poor patient compliance, and changes in the axis of the mandibular anterior teeth. Therefore, this study aimed to develop a new custom-made splint-type orthodontic appliance with CAD/CAM technology. Moreover, we evaluated the characteristics of the appliance and conducted functional tests to determine the effects of the appliance on the orofacial muscles and the discomfort associated with its use.
Claims 1-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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