DETAILED ACTION
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9-10 are rejected under 35 U.S.C. 112(d) or pre-AlA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 9-10 recite the limitations “wherein the applied vibratory force reduces incidence of awake bruxism” and “wherein the applied vibratory force reduces incidence of sleep bruxism”. These claims are not further limiting such that there are not any other steps being carried out and the “incidence of bruxism being less than without vibratory treatment” appear to be an inherent outcome of the claimed method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-2, 5, 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Furtenhofer (US 2019/0021816 A1), in view of Yang (CN109453017A), see translation provided, and further in view of Perdovich (US 2018/0353122 A1).
Regarding claim 1, Furtenhofer teaches a method, comprising:
Obtaining a vibrational dental device (1a, 1b, see Figures and [0059-0062]; the mouthpiece is a bite plate and vibrates through vibration generators 5);
wherein the vibrational dental device has a mouthpiece for contacting at least a portion of the occlusal surfaces of the dentition of the patient (see 3 in Figures 1-2);
placing the mouthpiece over the dentition (see Figures 11-13 and [0020]); and
applying a vibratory force during a predetermined number of sessions throughout a predetermined treatment period ([0014], [0035]; the vibration is meant to be adjusted for a desired duration and for repetitive use) to the patient while awake ([0004], [0035]; the device is controlled and operated by the patient using a push-button and a remote control such as a smart phone and it is obvious that the device needs to be inserted into the patient’s mouth for it to be used and so they must be awake to operate it);
Furtenhofer teaches the device reduces the muscular stress in the masticatory muscle and the device reduces the tooth damage resulting from bruxism is simultaneously prevented (par. 15). Although the device and method of Furtenhofer appear to reduce the effects of bruxism, and it must reduce clenching for it to reduce the effects of it on the teeth, it does not explicitly teach that the device is used for treating bruxism and is worn by a patient having bruxism or wherein the incidence of bruxism is less than without vibratory treatment.
Yang teaches a massaging brace device (1) comprising a vibration device (6) that is used to reduce excessive tension in the muscles of the mouth and therefore reduce/treat bruxism (see page 1 of translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use the device of Furtenhofer to treat and reduce bruxism, as taught by Yang, as it would directly provide vibrations to the teeth and relax the muscles of the jaws and therefore prevent tooth damage resulting from bruxism.
Furtenhofer is silent to the method comprising: monitoring the incidence of bruxism in the patient.
Predovich teaches an apparatus and method in the same field of endeavor of treating oral conditions (abstract). Predovich teaches the device detects bruxism and the user can adjust their therapy they are using to treat bruxism ([0085]). Perdovich teaches the user can see how many times they grinded or clenched their teeth and see how well their therapy is progressing over time by comparing nightly events of bruxism over the course of several days or weeks ([0085]).
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method to include monitoring when clenching occurs and adjusting the therapy, as taught by Perdovich, because it would allow the user to track the progress of the therapy and to control the intensity of the device as needed.
Regarding claim 2, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). Furtenhofer teaches wherein the frequency is ranging from 45 Hz to 150 Hz ([0040]; The frequency can be selected within a needed range for a respective treatment and so it can range between 0 Hz and 1000 Hz, preferably between 0 Hz and 300 Hz).
Regarding claim 5, Furtenhofer in view of Yang and Perdovich teaches the method of claim 2 (see rejection above). Furtenhofer teaches wherein the frequency is about 113 Hz ([0040]; The frequency can be selected within a needed range for a respective treatment and so it can range between 0 Hz and 1000 Hz, preferably between 0 Hz and 300 Hz).
Regarding claim 9, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). The combination teaches wherein the applied vibratory force reduces incidence of awake bruxism. Furtenhofer teaches the device is controlled and operated by the user using a push-button and a remote control and so the device needs to be inserted into the patient’s mouth for it to be used and so the user must be awake to put it in their mouth and operate it. The combination teaches the device treats bruxism and therefore it would occur less. Note that the claimed limitation appears to be an inherent outcome of the method (see MPEP 2112.02) and therefore since the device operates and is used as claimed, then inherently, the results would be the same as claimed.
Regarding claim 10, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). Yang teaches the device is used to relieve night time bruxism (see page 1 of translation) and therefore the combination teaches wherein the applied vibratory force reduces incidence of sleep bruxism. Note that the claimed limitation appears to be an inherent outcome of the claimed method (see MPEP 2112.02). Yang teaches the claimed method and a device used in the same manner (i.e., applying vibratory treatment). Therefore, the method will inherently reduce the occurrence of bruxism.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to treat sleep/nighttime bruxism in addition to awake bruxism, since bruxism occurs a lot at night and treating it at all times is necessary to prevent its side effects.
Regarding claim 11, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). Perdovich teaches the method futher comprising adjusting a dosage of the vibratory force based upon the results of the monitoring ([0058]; such that the therapy and vibration intensity can be adjusted by the user).
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method to include monitoring when clenching occurs and adjusting the therapy, as taught by Perdovich, because it would allow the user to track the progress of the therapy and to control the intensity of the device as needed.
Regarding claim 12, Furtenhofer in view of Yang and Perdovich teaches the method of claim 11 (see rejection above). Furtenhofer teaches the device is made to be comfortably and easily handled by the patient ([0004]) and can be controlled via a smartphone app such that specific types of pulses, relating to the type, duration, frequency, and/or intensity of the vibration and/or pulse pattern, which can also comprise pulse intervals with identical or different types of pulses in addition to the impulse type ([0035] and see claim 8). Perdovich teaches the therapy may be controlled in response to the bruxism detector feedback ([0058]). Therefore, the combination teaches wherein the dosage includes at least one of a durations per use, a number of uses per day, or a number of days of use.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to adjust the duration or frequency of the vibration, as taught by Furtenhofer, because it would provide control over the therapy and allow adjustment according to the user’s comfort and need.
Regarding claim 13, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). Furtenhofer teaches the device is made to be comfortably and easily handled by the patient ([0004]) and can be controlled via a smartphone app such that specific types of pulses, relating to the type, duration, frequency, and/or intensity of the vibration and/or pulse pattern, which can also comprise pulse intervals with identical or different types of pulses in addition to the impulse type ([0035] and see claim 8). Perdovich teaches the therapy may be controlled in response to the bruxism detector feedback ([0058]). Therefore, the combination teaches adjusting the acceleration of the vibratory force based upon the results of the monitoring.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to adjust the therapy such pulse pattern or intensity, specifically acceleration, because it would provide control over the therapy and allow adjustment according to the user’s comfort and need.
Regarding claim 14, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). Furtenhofer teaches the device is made to be comfortably and easily handled by the patient ([0004]) and can be controlled via a smartphone app such that specific types of pulses, relating to the type, duration, frequency, and/or intensity of the vibration and/or pulse pattern, which can also comprise pulse intervals with identical or different types of pulses in addition to the impulse type ([0035] and see claim 8). Perdovich teaches the therapy may be controlled in response to the bruxism detector feedback ([0058]). Therefore, the combination teaches adjusting the frequency of the vibratory force based upon the results of the monitoring.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to adjust the duration, intensity or frequency of the vibration, based on the feedback, because it would provide control over the therapy and allow adjustment according to the user’s comfort and need.
Claims 3, 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Furtenhofer (US 2019/0021816 A1), in view of Yang (CN109453017A), see translation provided, Perdovich (US 2018/0353122 A1), and further in view of Lowe (US 2015/0079533 A1).
Regarding claim 3, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above), but is silent to wherein the duration is ranging from 30 seconds to 20 minutes.
Lowe teaches a device for use in a method in the same field of endeavor of devices for treating oral conditions using vibration force (abstract). Lowe teaches the method includes a mouthpiece-type device (10) is placed on the dentition of the patient (see Figures 1A-1B) and can be used for types of maxillofacial applications such as TMJ ([0054]). Lowe teaches the system is provided with patient instructions on use and can be worn for a predetermined of period for a certain amount of time over a suitable duration of time ([0060]). Lowe teaches wherein the duration is ranging from 30 seconds to 20 minutes ([0060]; “The system can be worn for a predetermined period such as approximately twenty minutes”).
TMJ is known in the art to share many symptoms with Bruxism and Bruxism can usually signify or lead to TMJ. It is known that both disorders can be treated in a similar manner and relaxation of the jaw muscles is a technique that would relieve symptoms of both disorders.
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method to have a treatment time of approximately 20 minutes, as taught by Lowe, because it would be sufficient to relax the jaw muscles to help with maxillofacial traumas such as TMJ or bruxism while allowing use during everyday activities such as reading a book, chores, or cleaning.
Regarding claim 6, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above), but is silent to wherein the session time is from 30 seconds to 20 minutes.
Lowe teaches a device for use in a method in the same field of endeavor of devices for treating oral conditions using vibration force (abstract). Lowe teaches the method includes a mouthpiece-type device (10) is placed on the dentition of the patient (see Figures 1A-1B) and can be used for types of maxillofacial applications such as TMJ ([0054]). Lowe teaches the system is provided and can be worn for a predetermined of period of time such as approximately 20 minutes once a day or more, or any suitable duration of time, thus the patient can wear the device at home for a modest wear duration and that the vibrator can be activated for about 5, 10, 15 or 20 minutes or more. This can be daily, or preferably twice daily, or more [0069].
TMJ is known in the art to share many symptoms with Bruxism and Bruxism can usually signify or lead to TMJ. It is known that both disorders can be treated in a similar manner and relaxation of the jaw muscles is a technique that would relieve symptoms of both disorders.
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method to have a treatment time of approximately 20 minutes, as taught by Lowe, because it would be sufficient to relax the jaw muscles to help with maxillofacial traumas such as TMJ or bruxism while allowing use during everyday activities such as reading a book, chores, or cleaning.
Regarding claim 7, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above), but is silent to where sessions are repeated daily/every other day/semi-weekly/weekly.
Lowe teaches a device for use in a method in the same field of endeavor of devices for treating oral conditions using vibration force (abstract). Lowe teaches the method includes a mouthpiece-type device (10) is placed on the dentition of the patient (see Figures 1A-1B) and can be used for types of maxillofacial applications such as TMJ ([0054]). Lowe teaches the system is provided and can be worn for a predetermined of period of time such as approximately 20 minutes once a day or more, or any suitable duration of time, thus the patient can wear the device at home for a modest wear duration and that the vibrator can be activated for about 5, 10, 15 or 20 minutes or more. This can be daily, or preferably twice daily, or more [0069].
TMJ is known in the art to share many symptoms with Bruxism and Bruxism can usually signify or lead to TMJ. It is known that both disorders can be treated in a similar manner and relaxation of the jaw muscles is a technique that would relieve symptoms of both disorders.
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method to have a treatment time of approximately 20 minutes for any session frequency, as taught by Lowe, because it would be sufficient to relax the jaw muscles to help with maxillofacial traumas such as TMJ or bruxism while allowing use during everyday activities such as reading a book, chores, or cleaning and depending on the needs of the patient, the session/wear frequency can vary.
Furtenhofer does not explicitly teach a treatment period may be from daily/every other day/semi-weekly/weekly. However, since the device of Furtenhofer is used for relaxation of the jaw muscles and nerves ([0015]) and the duration and settings are adjusted based on a treatment profile ([0035]) and is rechargeable for repetitive use ([0016]), it would have been obvious that the length of a treatment is user dependent such that it can be used for as long as needed to achieve the desired results.
Regarding claim 8, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above). Lowe teaches a device for use in a method in the same field of endeavor of devices for treating oral conditions using vibration force (abstract). Lowe teaches the method includes a mouthpiece-type device (10) is placed on the dentition of the patient (see Figures 1A-1B) and can be used for types of maxillofacial applications such as TMJ ([0054]). Lowe teaches the system is provided and can be worn for a predetermined of period of time such as approximately 20 minutes once a day or more, or any suitable duration of time, thus the patient can wear the device at home for a modest wear duration and that the vibrator can be activated for about 5, 10, 15 or 20 minutes or more. This can be daily, or preferably twice daily, or more [0069].
TMJ is known in the art to share many symptoms with Bruxism and Bruxism can usually signify or lead to TMJ. It is known that both disorders can be treated in a similar manner and relaxation of the jaw muscles is a technique that would relieve symptoms of both disorders.
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the method to have a treatment time of approximately 20 minutes for any session frequency, as taught by Lowe, because it would be sufficient to relax the jaw muscles to help with maxillofacial traumas such as TMJ or bruxism while allowing use during everyday activities such as reading a book, chores, or cleaning and depending on the needs of the patient, the session/wear frequency can vary.
Furtenhofer does not explicitly teach the treatment period is from 1 day to 1 year.
teach a treatment period may be from daily/every other day/semi-weekly/weekly. However, since the device of Furtenhofer is used for relaxation of the jaw muscles and nerves ([0015]) and the duration and settings are adjusted based on a treatment profile ([0035]) and is rechargeable for repetitive use ([0016]), it would have been obvious that the length of a treatment is user dependent such that it can be used for as long as needed to achieve the desired results.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Furtenhofer (US 2019/0021816 A1), in view of Yang (CN109453017A), see translation provided, Perdovich (US 2018/0353122 A1), and further in view of Teixeira et al. (US 2010/0092916 A1).
Regarding claim 4, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above), but is silent to wherein the acceleration of the mouthpiece ranged from 0.010 G to 0.15 G.
Teixeira et al. teaches a device in the same field of endeavor of devices that apply vibration to the jaw and/or teeth (abstract). Teixeira teaches a tooth brush (10), a bite plate (100), and a massaging device (200) for different uses including bone regeneration, physiologic stimulation, orthodontic treatment, bone growth promotion, tooth cleaning ([0034-0043]) and that the device applies vibration with an acceleration peak of 0.1 g to 2.0 g to produce a microstrain of 1 to 50 in the jaw and/or teeth ([0042-0043]).
It would have been obvious for one having ordinary skill in the art before the effective filing date to modify the device to have an acceleration between 0.1 g to 2.0 g, as taught by Teixeria et al., as it would accommodate a suitable range for targeting different muscles for the different applications the device is to be used for such as pain reduction, speech impediment relaxation, bruxism reduction.
Claims 15 are rejected under 35 U.S.C. 103 as being unpatentable over Furtenhofer (US 2019/0021816 A1), in view of Yang (CN109453017A), see translation provided, Perdovich (US 2018/0353122 A1), and further in view of Way et al. (US 2013/0273490 A1).
Regarding claim 15, Furtenhofer in view of Yang and Perdovich teaches the method of claim 1 (see rejection above), but is silent to explicitly the vibratory force includes a low- magnitude high-frequency vibration.
Way teaches a device for providing vibrations for use in a patient’s mouth (see Figures and abstract) and discusses that it has been shown that low magnitude high frequency forces are able to stimulate bone formation and increase bone mass ([0003]) and the device may be used for orthodontic retention ([0004]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the device to include low-magnitude high frequency vibrations, because Way demonstrates that it is a suitable force for use in a patient’s mouth and on the oral musculature.
Response to Arguments
Applicant’s arguments regarding the 35 USC 112(d) rejections are not found to be persuasive. Applicant argues that claims 9-10 explicitly refer to independent claim 1 and each introduce a further limitation on the subject matter of claim 1, such that the limitations narrow the scope of the claim by requiring that the applied forces to reduce the incidence of bruxism – either during wakefulness or sleep. However, claims 9-10 still do not recite any other steps being carried out and the limitations claimed relating to the incidence of bruxism being less appear to merely be an inherent outcome of the claimed method steps (see MPEP 2112.02). Therefore, those limitations are not further limiting. It should be noted that since the prior art teaches all of the claimed method steps and a device being operated and used in the same manner as claimed, the effect of the method will inherently be the same as claimed.
Applicant’s arguments filed 12/8/2025 have been considered but are not persuasive. With regards to applicant’s arguments that the combination does not teach or suggest applying a vibratory force “to the patient while awake”, it should be noted that Furtenhofer teaches the device is intended to be operated easily and comfortably by the patient ([0004]) and being operated remotely by a smartphone to adjust the parameters of the device ([0035]). Therefore, it would have been obvious to a person of ordinary skill in the art that the force is applied when the patient is awake since they operate the device. Since Furtenhofer teaches the patient controlling the device via a smartphone, it requires them to be awake to operate the device and eliminates the possibility of a practitioner inserting it under anesthesia and just like a patient can insert the device and go to sleep, they can also wake up with the device after it has been on.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 attached to this office action.
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 LINA FARAJ whose telephone number is (571)272-4580. The examiner can normally be reached Monday-Friday.
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/LINA FARAJ/ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
2/11/2026