DETAILED ACTION
This action is in response to the Request for Continued Examination (RCE) filed 2/20/2026. Currently, claims 43-55, 58-60, 62-81 and 84 are pending in the application. Claims 1-42, 56, 57, 61, 82 and 83 are cancelled by Applicant. Claims 48, 63, 64, 67, 70, 74 and 84 are withdrawn and not examined at this point.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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/10/2026 has been entered.
Response to Arguments
Applicant’s amendment to claim 79 is sufficient to overcome the previous rejection of claim 79 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Applicant’s amendment to claim 62 is sufficient to overcome the previous rejection of claim 62 under .S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant’s amendments to claims 75 and 76 are sufficient to overcome the previous rejection of claims 75 and 76 under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant's arguments filed 2/10/2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that Lowe does not teach the vibration motor located outside the mouthpiece, wherein the tube is coupled between the vibration motor and the mouthpiece to transmit the vibrational force from the vibration motor to a lip of the user, the examiner respectfully disagrees. As detailed below, Lowe teaches the feedback signal generator (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) comprising a motor configured to provide vibrational force as the feedback (column 4, lines 61-63 teaches “vibration is most commonly provided via a motor that rotates a shaft having an unbalanced or eccentric weight (off-set motor)”), the vibration located outside (“extraoral housing” taught in column 16, line 64; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator;” Figures 13A and 13B teach the housing 2001 being located external of the bite plate 1000) the mouthpiece (bite plate 1000), wherein the tube (stem 1008, cylindrical shaft 1009; shown in Figure 10B to have a tubular structure) is coupled between (column 16, lines 62-64 teaches “also shown in FIG. 10A-B is the stem (1008), which is the portion of the bite plate (1000) that mates with a corresponding socket in the extraoral housing”) the motor (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator;” column 4, lines 61-63 teaches “vibration is most commonly provided via a motor that rotates a shaft having an unbalanced or eccentric weight (off-set motor)”) and the mouthpiece (bite plate 1000) to transmit the vibrational force from the motor to a lip of the user (column 19, lines 23-24 teaches “vibration applied to the bite plate, tooth positioner, or other intraoral functional appliance;” in use, vibration would be transferred to a lip of the user via the bite plate, tooth positioner, or other intraoral functional appliance).
In response to applicant's argument that Lowe does not teach transmitting the vibrational force from the motor to a lip of the user, the examiner reminds Applicant that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. While Lowe teaches “vibration applied to the bite plate, tooth positioner, or other intraoral functional appliance” (as Applicant notes), the device of Lowe is capable of transmitting the vibrational force from the motor to a lip of the user inasmuch as vibration would be transferred to a lip of the user via the bite plate, tooth positioner, or other intraoral functional appliance in use.
In response to applicant's argument that Jones does not teach wherein the apparatus is configured to determine the pressure threshold by averaging the pressure values in a temporal window, the examiner again reminds Applicant that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the present case, the device of Jones is capable of determining the pressure threshold by averaging the pressure values in a temporal window for at least the reason(s) presented in the rejection of claim 79 below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “processing module” in claims 43, 44, 54-55, 60, 65, 69, 71 and 73.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following structure(s) as performing the claimed function: a housing; and a pressure sensor contained in the housing, the pressure sensor configured to detect a pressure due to a biting force applied to a mouthpiece by a user (see [0314] of the publication of the present application).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “feedback signal generator” in claim 62.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following structure(s) as performing the claimed function: vibration motor.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “communication unit” in claim 71.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following structure(s) as performing the claimed function: wireless device or cable port.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 43-47, 49, 51-55, 58, 71, 72, 73, 75 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1) in view of Lowe (US 8,500,446 B2).
In regards to claim 43, Al-Tawil teaches in Figures 1-2A, [0052], [0055], [0098], [0100] and [0111] a mouthpiece (mouth piece 200) configured for placement inside a mouth of a user ([0052] teaches “mouth piece 200 is dimensioned and configured to be placed within a patient's mouth”); a processing module (electronics box 140 and transducers 110 contained in the electronics box 140; [0100] teaches “transducers 110 are in the nature of pressure sensors; [0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user); and a tube (mouth piece tubes 250) having a first end coupled to (as shown in Figure 1; [0055] teaches “six ports 225--three on each side of the mouth piece 200--are seen at the front of the mouth piece 200” and “these ports 225 are dimensioned to receive the fluid tubes 250;” [0098] teaches “the tubes 250 may be referred to as mouth piece tubes as they extend from the mouth piece 200”) the mouthpiece (mouth piece 200), and a second end coupled to (as shown in Figure 1; [0098] teaches “the electronics box 140 is framed by side walls 145. A front wall 145f of the electronics box 140 includes a manifold 130,” “the manifold 130 includes an array of nozzles 142 extending outwardly from the front wall 145f” and “the nozzles 142 receive respective tubes 250”) the processing module (electronics box 140 and transducers 110 contained in the electronics box 140); wherein the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) comprises a sensor configured to detect a characteristic due to a biting force applied to the mouthpiece by the user ([0100] teaches “transducers 110 are in the nature of pressure sensors; [0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user).
Al-Tawil does not teach wherein the processing module comprises a feedback signal generator configured to provide a feedback, the feedback signal generator comprising a motor configured to provide vibrational force as the feedback, the motor located outside the mouthpiece, wherein the tube is coupled between the motor and the mouthpiece to transmit the vibrational force from the motor to a lip of the user, and wherein the feedback has an intensity.
However, Lowe teaches in Figures 10A-13B, column 4, lines 61-63, column 6, lines 3-4, column 16, lines 62-67 and column 17, line 58 an analogous device wherein the processing module (“extraoral housing” taught in column 16, line 64; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) comprises a feedback signal generator (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) configured to provide a feedback (vibration; column 6, lines 3-4 teaches “an orthodontic vibrator that vibrates within the frequency and power”), the feedback signal generator (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) comprising a motor configured to provide vibrational force as the feedback (column 4, lines 61-63 teaches “vibration is most commonly provided via a motor that rotates a shaft having an unbalanced or eccentric weight (off-set motor)”), the vibration located outside (“extraoral housing” taught in column 16, line 64; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator;” Figures 13A and 13B teach the housing 2001 being located external of the bite plate 1000) the mouthpiece (bite plate 1000), wherein the tube (stem 1008, cylindrical shaft 1009; shown in Figure 10B to have a tubular structure) is coupled between (column 16, lines 62-64 teaches “also shown in FIG. 10A-B is the stem (1008), which is the portion of the bite plate (1000) that mates with a corresponding socket in the extraoral housing”) the motor (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator;” column 4, lines 61-63 teaches “vibration is most commonly provided via a motor that rotates a shaft having an unbalanced or eccentric weight (off-set motor)”) and the mouthpiece (bite plate 1000) to transmit the vibrational force from the motor to a lip of the user (column 19, lines 23-24 teaches “vibration applied to the bite plate, tooth positioner, or other intraoral functional appliance;” in use, vibration would be transferred to a lip of the user via the bite plate, tooth positioner, or other intraoral functional appliance), and wherein the feedback has an intensity (see “vibratory force” taught in column 19, lines 23-37).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the processing module of Al-Tawil to include that the processing module comprises a feedback signal generator configured to provide a feedback, the feedback signal generator comprising a motor configured to provide vibrational force as the feedback, the motor located outside the mouthpiece, wherein the tube is coupled between the motor and the mouthpiece to transmit the vibrational force from the motor to a lip of the user, and wherein the feedback has an intensity as taught by Lowe because this element is known to enable the apparatus “be used to treat all forms and classifications of dental malocclusion” (see column 6, lines 42-44 of Lowe), which is known in the art to be causal of bruxism.
In regards to claim 44, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0111] that the tube (mouth piece tubes 250) is configured to provide a pressure to the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) in response to the biting force ([0111] teaches “during a period of sleep, the patient may begin to grind his or her teeth,” “this causes changes in pressure within the cells of the mouth piece 200” and “the changes in pressure within the cells are delivered pneumatically or fluidically, depending on the fluid used, to the transducers 110 through the respective tubes 250”).
In regards to claim 45, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0066] and [0069] that the mouthpiece (mouth piece 200) comprises a first cavity (cells 232A, 234A, 236A, 232B, 234B, 236B; [0066] teaches “each cell 232A, 234A, 236A, 232A, 234B, 236C holds a volume of fluid” and thus, each cell must define a cavity for holding fluid therein) configured to be in fluid communication with a lumen of ([0069] teaches “cells 232A, 234A, 236A, 232B, 234B, 236B of the mouth piece 200 are in fluid communication with respective tubes 250”) the tube (mouth piece tubes 250).
In regards to claim 46, Al-Tawil and Lowe teach the apparatus of claims 43 and 45. Al-Tawil teaches in Figure 2E that the first cavity (cells 232A, 234A, 236A, 232B, 234B, 236B) is on one of a left side or a right side of (as shown in Figure 2E) the mouthpiece (mouth piece 200).
In regards to claim 47, Al-Tawil and Lowe teach the apparatus of claims 43, 45 and 46. Al-Tawil teaches in Figures 2A-2C that the mouthpiece (mouth piece 200) further comprises a spacer (left 210A and right 210B sides; left 210A and right 210B sides provide a physical barrier to separate, or space, the user’s upper and lower dentition from one another) at another one of the left side or the right side of (as shown in Figured 2A and 2B) the mouthpiece (mouth piece 200).
In regards to claim 49, Al-Tawil and Lowe teach the apparatus of claims 43 and 45. Al-Tawil teaches in [0111] that the first cavity (cells 232A, 234A, 236A, 232B, 234B, 236B) is variable (by changing pressure therein) in response to a compression applied to ([0111] teaches “during a period of sleep, the patient may begin to grind his or her teeth” and “this causes changes in pressure within the cells of the mouth piece 200”) the mouthpiece (mouth piece 200).
In regards to claim 51, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0065] that the mouthpiece (mouth piece 200) is a customized mouthpiece ([0065] teaches “the mouth piece 200 may need to be custom-designed to match the patient's specific dental anatomy”).
Applicant should note that claim 51 limitation “customized” is a product-by-process claim limitation. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
In regards to claim 52, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0020] and [0026] that the tube (mouth piece tubes 250) is integrally formed with ([0020] teaches “an integral connection between the distal end of the tubes and respective walls of the mouth piece;” [0026] teaches “the distal end of the tubes may be integral to the mouth piece”) the mouthpiece (mouth piece 200).
In regards to claim 53, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0026] that the first end of the tube (mouth piece tubes 250) is configured to detachably couple to ([0026] teaches “the tubes are removable from the mouth piece”) the mouthpiece (mouth piece 200).
In regards to claim 54, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0028] that the second end of the tube (mouth piece tubes 250) is configured to detachably couple to ([0028] teaches “the tubes are removable from the transducers”) the processing module (electronics box 140 and transducers 110 contained in the electronics box 140).
In regards to claim 55, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in Figure 1 that the tube (mouth piece tubes 250) is configured to maintain the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) outside the mouth of the user while the mouthpiece (mouth piece 200) is inside the mouth of the user (Figure 1 teaches the intra-oral system 100 being structured such that the electronics box 140 can be positioned outside the user’s mouth while the mouth piece 200 is positioned therein).
In regards to claim 58, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil does not teach wherein the intensity is sufficient to cause the user to stop or reduce the biting force.
However, Lowe teaches in column 6, lines 42-44 and column 19, lines 23-37 an analogous device wherein the intensity (see “vibratory force” taught in column 19, lines 23-37) is sufficient to cause the user to stop or reduce the biting force (column 19, lines 23-24 teaches “vibration applied to the bite plate, tooth positioner, or other intraoral functional appliance;” such vibration is capable of startling a patient, causing the user to stop or reduce a biting force; column 6, lines 42-44 teaches that the vibration is known to enable the apparatus “be used to treat all forms and classifications of dental malocclusion,” which is known in the art to be causal of bruxism; thus, treatment of dental malocclusion is capable of reducing bruxism and thus, causing the user to stop or reduce a biting force).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the intensity of Al-Tawil as modified by Lowe to be sufficient to cause the user to stop or reduce the biting force as taught by Lowe because this element is known to enable the apparatus “be used to treat all forms and classifications of dental malocclusion” (see column 6, lines 42-44 of Lowe), which is known in the art to be causal of bruxism.
In regards to claim 71, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0116] that the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) comprises ([0116] teaches “the electronics box 140 has a data port 55”) a communication unit (data port 55) configured to communicate with ([0116] teaches “the data port 55 may be a wireless transmitter that transmits signals from the processor 120 to a general purpose computer, shown at 160” and “the data port 55 is a USB port for connecting the electronics box 150 with the general purpose computer 160 using a cable 156”) an external device (computer 160), wherein the communication unit (data port 55) comprises a wireless device ([0116] teaches “the data port 55 may be a wireless transmitter”) and/or a cable port ([0116] teaches “the data port 55 is a USB port for connecting the electronics box 150 with the general purpose computer 160 using a cable 156”).
In regards to claim 72, Al-Tawil and Lowe teach the apparatus of claim 43 and 71. Al-Tawil teaches in [0116] that the external device (computer 160) is a cell phone, a computer ([0116] teaches “the data port 55 may be a wireless transmitter that transmits signals from the processor 120 to a general purpose computer, shown at 160” and “the data port 55 is a USB port for connecting the electronics box 150 with the general purpose computer 160 using a cable 156”), a server, a tablet, or a watch.
In regards to claim 73, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0093] that the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) comprises a battery, and a circuitry ([0093] teaches “the electronics box 440 is configured to house electronics for operating the bite pressure monitoring system 100” and “the electronics may include transducers, a processor, a battery, and an integrated circuit board”).
Al-Tawil does not teach that the battery is rechargeable.
However, Lowe teaches in the abstract an analogous device wherein the battery is rechargeable (the abstract teaches “an extraoral housing containing a rechargeable battery coupled to a vibrator coupled to a processor coupled to data and charging port or ports”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the battery of Al-Tawil as modified by Lowe to be rechargeable as taught by Lowe because this element is known to be “preferred for longer product life,” as Lowe teaches in column 5, lines 64-65.
In regards to claim 75, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches in [0050], [0103] and [0121-0122] that the apparatus is configured to store: a time-series of pressure values outputted by the sensor ([0121] teaches “the pressure profile represents a magnitude of pressure from within the cells as a function of time” and [0122] teaches “the processor 520 stores the pressure profile in memory”), a time-series of pressure threshold values, sound data recorded during a sleeping event of the user, or two or more of the foregoing.
In regards to claim 76, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil does not teach that the apparatus is configured to store a time at which the feedback is provided to the user.
However, Lowe teaches in column 6, lines 3-4, column 11, lines 46-49, column 17, line 58 and column 18, lines 36-64 an analogous device wherein the apparatus is configured to store a time at which the feedback (vibration; column 6, lines 3-4 teaches “an orthodontic vibrator that vibrates within the frequency and power”) is provided to the user (column 11, lines 48-49 teaches “the processor 39 stores instructions and data in its memory 52;” see column 18, lines 36-64).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apparatus of Al-Tawil as modified by Lowe to provide that the apparatus is configured to store a time at which the feedback is provided to the user as taught by Lowe because this element is known to provide that “the healthcare professional, patient, or parent/guardian can measure patient compliance and usage patterns that have occurred between appointment” and “patient compliance is greatly enhanced through computer monitoring of usage,” as Lowe teaches in column 7, lines 13-15 and 21-23.
Claim(s) 59, 60, 65 and 66 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1), in view of Lowe (US 8,500,446 B2) and further in view of Radmand (US 2020/0038231 A1).
In regards to claim 59, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil and Lowe do not teach that the intensity of the feedback is based on a failure or a success of a previous feedback to cause a reaction from the user.
However, Radmand teaches in [0034-0036] an analogous device wherein the intensity ([0035] teaches the stimulation being “gentle”) of the feedback (“stimulation”) is based on a failure or a success of a previous feedback to cause a reaction from the user ([0036] teaches “the stimulator 40 provides stimulation until the force applied to occlusal and/or bite surfaces of the user's teeth are below a predetermined force level” and “the stimulator 40 may stop stimulation once the pressure sensors 32 detect that grinding and/or clenching has substantially decreased and/or ceased, as evidenced by the detected force level”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the intensity of the feedback of Al-Tawil as modified by Lowe to be based on a failure or a success of a previous feedback to cause a reaction from the user as taught by Radmand because this element is known to enable the intensity of the feedback to be selectively applied to substantially decrease and/or cease grinding and/or clenching by the user, as Radmand teaches in [0036].
In regards to claim 60, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil and Lowe do not teach that the processing module is configured to detect a snoring of the user, and wherein the intensity is sufficient to cause the user to stop the snoring.
However, Radmand teaches in [0021] and [0034-0035] an analogous device wherein the processing module (oxygen sensors 30, pressure sensors 32, airflow sensors 34, noise detector 35, stimulator 40, microprocessor 50 and data recorder 60) is configured to detect a snoring of the user ([0034] teaches “a noise detector 35 configured to detect actual noise and/or vibrations caused by the user's snoring”), and wherein the intensity ([0035] teaches the stimulation being “gentle”) is sufficient to cause the user to stop the snoring ([0021] teaches “providing electrical stimulation to a user's tongue to inhibit and/or limit snoring”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the processing module of Al-Tawil as modified by Lowe to be configured to detect a snoring of the user, and wherein the intensity is sufficient to cause the user to stop the snoring as taught by Radmand because this element is known to enable the intensity to be selectively applied in response to snoring “to inhibit and/or limit snoring that may be caused by obstructive sleep apnea,” as Radmand teaches in [0021] and [0036].
In regards to claim 65 and 66, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil and Lowe do not teach that the processing module is configured to determine whether the user is having an apnea event or not, and wherein the apparatus is configured to provide the feedback to the user after determining that the user is having the apnea event; and wherein the intensity of the feedback is sufficient to cause the user to stop the apnea event.
However, Radmand teaches in [0021] and [0034-0036] an analogous device wherein the processing module (oxygen sensors 30, pressure sensors 32, airflow sensors 34, noise detector 35, stimulator 40, microprocessor 50 and data recorder 60) is configured to determine whether the user is having an apnea event or not ([0034] teaches “a noise detector 35 configured to detect actual noise and/or vibrations caused by the user's snoring;” [0036] teaches “stimulator 40 may be activated if the oxygen sensor 30 determines that the actual oxygen saturation level of hemoglobin of the user is at a predetermined oxygen level, that is, that a certain oxygen level has been pre-determined to be insufficient,” “stimulator 40 is activated when the airflow sensor 34 determines that the frequency of air inhaled and/or exhaled by the user is below a predetermined airflow level” and “stimulator 40 is activated if the noise detector 35 detects that the actual noise and/or vibrations are above a predetermined noise level”), and wherein the apparatus (oral appliance 10) is configured to provide feedback (“stimulation”) to the user after determining that the user is having the apnea event ([0036] teaches “stimulator 40 may be activated if the oxygen sensor 30 determines that the actual oxygen saturation level of hemoglobin of the user is at a predetermined oxygen level, that is, that a certain oxygen level has been pre-determined to be insufficient,” “stimulator 40 is activated when the airflow sensor 34 determines that the frequency of air inhaled and/or exhaled by the user is below a predetermined airflow level” and “stimulator 40 is activated if the noise detector 35 detects that the actual noise and/or vibrations are above a predetermined noise level”); and wherein the intensity of the feedback (“stimulation”) is sufficient to cause the user to stop the apnea event ([0021] teaches “providing electrical stimulation to a user's tongue to inhibit and/or limit snoring”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the processing module of Al-Tawil as modified by Lowe to provide that the processing module is configured to determine whether the user is having an apnea event or not, and wherein the apparatus is configured to provide feedback to the user after determining that the user is having the apnea event; and wherein the intensity of the feedback is sufficient to cause the user to stop the apnea event as taught by Radmand because this element is known to “facilitate an increase in respiratory flow to the user, thereby increasing the availability of oxygen to the user and the increase of oxygen saturation levels of hemoglobin,” as Radmand teaches in [0036].
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1), in view of Lowe (US 8,500,446 B2) and further in view of Marcil (US 2020/0155067 A1).
In regards to claim 50, Al-Tawil and Lowe teach the apparatus of claims 43 and 45. Al-Tawil teaches in the abstract that the first cavity (cells 232A, 234A, 236A, 232B, 234B, 236B) is “embedded” in the mouthpiece (mouth piece 200).
Al-Tawil and Lowe do not explicitly teach that the first cavity is between two or more layers of materials that are laminated together.
However, Marcil teaches in Figures 2b-3, [0039] and [0044] an analogous device wherein first cavity (tubular inner cavity 126; [0044] teaches “the sealed flexible tubing network 128 has an open end 130 connected to the fluid-pressure-sensing device 152”) is between (as shown in Figure 3) two or more layers (upper and lower recessed channels 118 and 120) of materials that are laminated (united) together (as shown in Figure 3).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the first cavity of Al-Tawil as modified by Lowe to provide that the first cavity is between two or more layers of materials that are laminated together as taught by Marcil because this element is known in the art to be a suitable configuration of a first cavity in fluid communication with a lumen of a tube, as Marcil teaches in Figures 2b-3, [0039] and [0044].
Claim(s) 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1), in view of Lowe (US 8,500,446 B2) and further in view of Lyon (US 2023/0148954 A1).
In regards to claim 62, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil and Lowe do not teach that the feedback signal generator also comprises a speaker configured to provide an audio output, or wherein the feedback signal generator comprises an LED configured to provide light.
However, Lyon teaches in [0070] an analogous device wherein the feedback signal generator (speaker 142) also comprises a speaker (speaker 142) configured to provide an audio output ([0070] teaches “the speaker 142 can be used, for example, as an alarm clock or to play an alert or message to the user 210 (e.g., in response to an event)”), or wherein the feedback signal generator comprises an LED configured to provide light.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the feedback signal generator of Al-Tawil as modified by Lowe to also comprise a speaker configured to provide an audio output as taught by Lyon because this element is known to enable the feedback signal generator to function informatively “as an alarm clock or to play an alert or message to the user 210 (e.g., in response to an event),” as Lyon teaches in [0070].
Claim(s) 68 and 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1), in view of Lowe (US 8,500,446 B2) and further in view of OSORIO MARTINI et al. (US 2022/0008243 A1).
In regards to claims 68 and 69, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil and Lowe do not teach an accelerometer configured to detect an orientation associated with the user; and wherein the processing module is configured to monitor a sleeping behavior of the user based on the detected orientation.
However, OSORIO MARTINI et al. teaches in [0006] and [0050] an analogous device with an accelerometer configured to detect an orientation associated with the user ([0006] teaches that “the smart night guard measures and records… movement through an embedded accelerometer”); and wherein the processing module (“software application” taught in [0006]) is configured to monitor a sleeping behavior of the user based on the detected orientation ([0006] teaches “the software application is configured to process the data output from the smart night guard and/or other user inputs to provide analysis such as, for example, statistical correlations of the data to show the effectiveness of recommended treatments for bruxism that are based on behavioral changes;” [0050] teaches “using accelerometer or geophysical location data to determine if the user is going to bed on time”).
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 Al-Tawil as modified by Lowe to further include an accelerometer configured to detect an orientation associated with the user; and wherein the processing module is configured to monitor a sleeping behavior of the user based on the detected orientation as taught by OSORIO MARTINI et al. because this element is known to provide a mechanism to “evaluate user compliance,” as OSORIO MARTINI et al. teaches in [0050].
Claim(s) 77, 78 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1), in view of Lowe (US 8,500,446 B2) and further in view of Jones (US 2020/0330261 A1).
In regards to claim 77, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches that the characteristic comprises pressure ([0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user).
Al-Tawil and Lowe do not teach that the apparatus is configured to provide the feedback to the user if the pressure due to the biting force exceeds a pressure threshold, wherein the pressure threshold has a constant value.
However, Jones teaches in [0035] an analogous device wherein the apparatus is configured to provide the feedback (“electrical impulses, shocks, and/or stimulations”) to the user if the pressure due to the biting force exceeds a pressure threshold ([0035] teaches “when the electrodes 226, 228 are in contact with a user's cheeks, the above-describe electrical impulses, shocks, and/or stimulations can be administered to the cheeks in response to the above-described bite pressure exceeding a predetermined pressure threshold”), wherein the pressure threshold has a constant value ([0035] teaches “a [single] predetermined pressure threshold”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apparatus of Al-Tawil as modified by Lowe to provide that the apparatus is configured to provide the feedback to the user if the pressure due to the biting force exceeds a pressure threshold, wherein the pressure threshold has a constant value as taught by Jones because this element is known to be “effective to interrupt the bruxing,” as Jones teaches in [0043].
In regards to claims 78 and 81, Al-Tawil and Lowe teach the apparatus of claim 43. Al-Tawil teaches that the characteristic comprises pressure ([0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user).
Al-Tawil and Lowe do not teach that the apparatus is configured to provide the feedback to the user if the pressure due to the biting force exceeds a pressure threshold, wherein the pressure threshold is variable over time; and wherein the pressure threshold has a value that is larger than a baseline pressure value associated with a non-bruxing event.
However, Jones teaches in [0007-0008], [0035], [0038] and [0044] an analogous device wherein the apparatus is configured to provide the feedback (“electrical impulses, shocks, and/or stimulations”) to the user if the pressure due to the biting force exceeds a pressure threshold ([0035] teaches “when the electrodes 226, 228 are in contact with a user's cheeks, the above-describe electrical impulses, shocks, and/or stimulations can be administered to the cheeks in response to the above-described bite pressure exceeding a predetermined pressure threshold”), wherein the pressure threshold is variable over time ([0008] teaches “a manual mode is available for users who prefer increased control over activation threshold pressure, shock intensity, and diurnal variations;” [0038] teaches “the interactive display can allow a user to control stimulation intensity, threshold pressure, day versus night variation, and automatic data uploading”); and wherein the pressure threshold has a value that is larger than a baseline pressure value associated with non-bruxing event (see [0007] and [0044], which teach “exceeding a predetermined pressure threshold” when bruxing in comparison to when “there is not bruxing”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apparatus of Al-Tawil as modified by Lowe to provide that the apparatus is configured to provide the feedback to the user if the pressure due to the biting force exceeds a pressure threshold, wherein the pressure threshold is variable over time; and wherein the pressure threshold has a value that is larger than a baseline pressure value associated with non-bruxing event as taught by Jones because this element is known to be “effective to interrupt the bruxing,” as Jones teaches in [0043].
Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1) in view of Jones (US 2020/0330261 A1).
In regards to claim 79, Al-Tawil teaches in Figures 1-2A, [0052], [0055], [0098], [0100] and [0111] a mouthpiece (mouth piece 200) configured for placement inside a mouth of a user ([0052] teaches “mouth piece 200 is dimensioned and configured to be placed within a patient's mouth”); a processing module (electronics box 140 and transducers 110 contained in the electronics box 140; [0100] teaches “transducers 110 are in the nature of pressure sensors; [0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user); and a tube (mouth piece tubes 250) having a first end coupled to (as shown in Figure 1; [0055] teaches “six ports 225--three on each side of the mouth piece 200--are seen at the front of the mouth piece 200” and “these ports 225 are dimensioned to receive the fluid tubes 250;” [0098] teaches “the tubes 250 may be referred to as mouth piece tubes as they extend from the mouth piece 200”) the mouthpiece (mouth piece 200), and a second end coupled to (as shown in Figure 1; [0098] teaches “the electronics box 140 is framed by side walls 145. A front wall 145f of the electronics box 140 includes a manifold 130,” “the manifold 130 includes an array of nozzles 142 extending outwardly from the front wall 145f” and “the nozzles 142 receive respective tubes 250”) the processing module (electronics box 140 and transducers 110 contained in the electronics box 140); wherein the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) comprises a sensor configured to detect a characteristic due to a biting force applied to the mouthpiece by the user ([0100] teaches “transducers 110 are in the nature of pressure sensors; [0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user); wherein the characteristic comprises pressure ([0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user).
Al-Tawil does not teach wherein the apparatus is configured to provide a feedback to the user if the pressure due to the biting force exceeds a pressure threshold, wherein the pressure threshold is variable based on pressure values associated with a non-bruxing event, and wherein the apparatus is configured to determine the pressure threshold by averaging the pressure values in a temporal window.
However, Jones teaches in [0007-0008], [0033], [0035], [0037-0038] and [0044] an analogous device wherein the apparatus is configured to provide a feedback (“electrical impulses, shocks, and/or stimulations”) to the user if the pressure due to the biting force exceeds a pressure threshold ([0035] teaches “when the electrodes 226, 228 are in contact with a user's cheeks, the above-describe electrical impulses, shocks, and/or stimulations can be administered to the cheeks in response to the above-described bite pressure exceeding a predetermined pressure threshold”), wherein the pressure threshold is variable based on pressure values associated with a non-bruxing event, and wherein the apparatus is configured to determine the pressure threshold by averaging the pressure values in a temporal window ([0035] teaches “when the electrodes 226, 228 are in contact with a user's cheeks, the above-describe electrical impulses, shocks, and/or stimulations can be administered to the cheeks in response to the above-described bite pressure exceeding a predetermined pressure threshold;” [0033] teaches “an integrated circuit controller 220 containing the logic for the operation of the BTS 200;” such logic includes determining the predetermined pressure threshold; see also [0037], which teaches “the integrated circuit controller 220, based on predetermined response curves [or, averages], commands a discharge of electricity from the battery 224 to the electrodes 226, 228;” [0038] teaches “the integrated circuit controller 220 uses an adaptive learning algorithm to determine the best settings based on historical data”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apparatus of Al-Tawil to provide that the apparatus is configured to provide a feedback to the user if the pressure due to the biting force exceeds a pressure threshold, wherein the pressure threshold is variable based on pressure values associated with a non-bruxing event, and wherein the apparatus is configured to determine the pressure threshold by averaging the pressure values in a temporal window as taught by Jones because this element is known to be “effective to interrupt the bruxing,” as Jones teaches in [0043].
Claim(s) 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Tawil (US 2012/0123225 A1), in view of Lowe (US 8,500,446 B2), in view of Jones (US 2020/0330261 A1) and further in view of WOO (US 2024/0398610 A1).
In regards to claim 80, Al-Tawil teaches in Figures 1-2A, [0052], [0055], [0098], [0100] and [0111] a mouthpiece (mouth piece 200) configured for placement inside a mouth of a user ([0052] teaches “mouth piece 200 is dimensioned and configured to be placed within a patient's mouth”); a processing module (electronics box 140 and transducers 110 contained in the electronics box 140; [0100] teaches “transducers 110 are in the nature of pressure sensors; [0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user); and a tube (mouth piece tubes 250) having a first end coupled to (as shown in Figure 1; [0055] teaches “six ports 225--three on each side of the mouth piece 200--are seen at the front of the mouth piece 200” and “these ports 225 are dimensioned to receive the fluid tubes 250;” [0098] teaches “the tubes 250 may be referred to as mouth piece tubes as they extend from the mouth piece 200”) the mouthpiece (mouth piece 200), and a second end coupled to (as shown in Figure 1; [0098] teaches “the electronics box 140 is framed by side walls 145. A front wall 145f of the electronics box 140 includes a manifold 130,” “the manifold 130 includes an array of nozzles 142 extending outwardly from the front wall 145f” and “the nozzles 142 receive respective tubes 250”) the processing module (electronics box 140 and transducers 110 contained in the electronics box 140); wherein the processing module (electronics box 140 and transducers 110 contained in the electronics box 140) comprises a sensor configured to detect a characteristic due to a biting force applied to the mouthpiece by the user ([0100] teaches “transducers 110 are in the nature of pressure sensors; [0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user). Al-Tawil teaches that the characteristic comprises pressure or force ([0111] teaches that the transducers 110 detect a pressure due to a biting force applied to mouth piece 200 by a user).
Al-Tawil does not teach wherein the processing module comprises a feedback signal generator configured to provide a feedback, the feedback signal generator comprising a motor configured to provide vibrational force as the feedback, the motor located outside the mouthpiece, wherein the tube is coupled between the motor and the mouthpiece to transmit the vibrational force from the motor to a lip of the user, and wherein the feedback has an intensity; and wherein the apparatus is configured to provide the feedback to the user if the pressure or force due to the biting force exceeds a pressure or force threshold, wherein the apparatus further comprises a temperature sensor, wherein an operation of the apparatus is based on an output provided by the temperature sensor.
However, Lowe teaches in Figures 10A-13B, column 4, lines 61-63, column 6, lines 3-4, column 16, lines 62-67 and column 17, line 58 an analogous device wherein the processing module (“extraoral housing” taught in column 16, line 64; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) comprises a feedback signal generator (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) configured to provide a feedback (vibration; column 6, lines 3-4 teaches “an orthodontic vibrator that vibrates within the frequency and power”), the feedback signal generator (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator”) comprising a motor configured to provide vibrational force as the feedback (column 4, lines 61-63 teaches “vibration is most commonly provided via a motor that rotates a shaft having an unbalanced or eccentric weight (off-set motor)”), the vibration located outside (“extraoral housing” taught in column 16, line 64; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator;” Figures 13A and 13B teach the housing 2001 being located external of the bite plate 1000) the mouthpiece (bite plate 1000), wherein the tube (stem 1008, cylindrical shaft 1009; shown in Figure 10B to have a tubular structure) is coupled between (column 16, lines 62-64 teaches “also shown in FIG. 10A-B is the stem (1008), which is the portion of the bite plate (1000) that mates with a corresponding socket in the extraoral housing”) the motor (vibrator; column 17, line 58 teaches “inside the housing is the battery, processor and vibrator;” column 4, lines 61-63 teaches “vibration is most commonly provided via a motor that rotates a shaft having an unbalanced or eccentric weight (off-set motor)”) and the mouthpiece (bite plate 1000) to transmit the vibrational force from the motor to a lip of the user (column 19, lines 23-24 teaches “vibration applied to the bite plate, tooth positioner, or other intraoral functional appliance;” in use, vibration would be transferred to a lip of the user via the bite plate, tooth positioner, or other intraoral functional appliance), and wherein the feedback has an intensity (see “vibratory force” taught in column 19, lines 23-37).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the processing module of Al-Tawil to include that the processing module comprises a feedback signal generator configured to provide a feedback, the feedback signal generator comprising a motor configured to provide vibrational force as the feedback, the motor located outside the mouthpiece, wherein the tube is coupled between the motor and the mouthpiece to transmit the vibrational force from the motor to a lip of the user, and wherein the feedback has an intensity as taught by Lowe because this element is known to enable the apparatus “be used to treat all forms and classifications of dental malocclusion” (see column 6, lines 42-44 of Lowe), which is known in the art to be causal of bruxism.
Al-Tawil and Lowe do not teach wherein the apparatus is configured to provide the feedback to the user if the pressure or force due to the biting force exceeds a pressure or force threshold, wherein the apparatus further comprises a temperature sensor, wherein an operation of the apparatus is based on an output provided by the temperature sensor.
However, Jones teaches in [0035] an analogous device wherein the apparatus is configured to provide the feedback (“electrical impulses, shocks, and/or stimulations”) to the user if the pressure or force due to the biting force exceeds a pressure or force threshold ([0035] teaches “when the electrodes 226, 228 are in contact with a user's cheeks, the above-describe electrical impulses, shocks, and/or stimulations can be administered to the cheeks in response to the above-described bite pressure exceeding a predetermined pressure threshold”), wherein the pressure threshold has a constant value ([0035] teaches “a [single] predetermined pressure threshold”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apparatus of Al-Tawil as modified by Lowe to provide that the apparatus is configured to provide the feedback to the user if the pressure or force due to the biting force exceeds a pressure or force threshold as taught by Jones because this element is known to be “effective to interrupt the bruxing,” as Jones teaches in [0043].
Al-Tawil, Lowe and Jones do not teach wherein the apparatus further comprises a temperature sensor, wherein an operation of the apparatus is based on an output provided by the temperature sensor.
However, WOO teaches in [0104] an analogous device wherein the apparatus further comprises a temperature sensor, wherein an operation of the apparatus is based on an output provided by the temperature sensor ([0104] teaches “the third sensor unit 126 may start an operation based on a temperature sensor”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the apparatus of Al-Tawil as modified by Lowe and Jones to provide that the apparatus further comprises a temperature sensor, wherein an operation of the apparatus is based on an output provided by the temperature sensor as taught by WOO because this element is known to enable the apparatus “to determine the timing at which the mounting module 120 is mounted within the mouth,” which can assist in monitoring use of the apparatus as WOO teaches in [0104].
Conclusion
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 3/17/2026