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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 9, 13, 15-17, 19-23, 26, 30, 32-34, 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner).
Regarding claim 1, Kandil teaches a method of regenerating a force within an aligner ([0005], [0033], [0037]), comprising:
receiving an aligner within a receptacle post-use by a patient ([0005], [0033], [0037], [0075]; a plastic aligner is put in a water bath to assume a second temporary shape as to provide a second form for the same stage aligner for more effective and accurate repositioning, the container being the container with the water bath); and
applying thermal energy to the aligner such that the aligner is maintained at a predetermined temperature for a predetermined period of time ([0060-0065]).
Kandil teaches heating an aligner to change its form. Kandil teaches when the second device is heated, the device introduces a second temporary form (and possibly further temporary forms) and finally the final shape such that the first temporary form of said device matches the final form of the first correction device ([0037-0041]). Kandil discusses that repeating a correction device a higher degree of accuracy is achieved by the orthodontic procedure ([0045]). Therefore, Kandil’s teachings indicate that the second aligner is heated as to achieve a final form of a previous aligner (i.e. an initial form).
Kandil does not explicitly teach the initial form of the aligner is a form prior to use by the patient and maintaining the thermal energy upon the aligner such that the aligner regenerates stress forces lost from use by the patient and regains said initial form.
Beier discusses that an aligner becomes deformed and with the changed shape, it loses its orthodontic force and further teaches placing the aligner in hot water as to restore its original shape. Beier teaches that this eliminates the need for replacing the aligner and additionally helps with making aligner placement less painful for the patient and disinfects the aligner (see paragraphs 2-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Kandil to involve explicitly returning the aligner form to a form prior to patient use, as discussed by Beier, because it would be applicable for repeating movements at a stage (i.e., restoring forces) as needed to achieve desired and accurate repositioning, which Kandil contemplates, without the need for an additional/repetitive aligner in between stages.
Regarding claim 2, Kandil in view of Beier teaches the method of claim 1 (see rejection above). Kandil teaches wherein receiving the aligner comprises immersing the aligner within a container filled with a fluid ([0033], [0065]).
Regarding claim 3, Kandil in view of Beier teaches the method of claim 2 (see rejection above). Kandil teaches wherein the fluid comprises water, aqueous solution, organic solvent, or any combination thereof ([0033], [0065]).
Regarding claim 9, Kandil in view of Beier teaches the method of claim 1 (see rejection above). Kandil teaches wherein applying thermal energy comprises applying an energy modality comprising electrical, hydrothermal ([0033], [0065]; water and/or heat can be used and therefore hydrothermal energy is applied), ultrasonic, radiative, electromagnetic, ultraviolet, infrared, or chemical heating.
Regarding claim 13, Kandil in view of Beier teaches the method of claim 1 (see rejection above). Kandil teaches wherein applying thermal energy comprises maintaining the aligner at the predetermined period of time of 1-5 minutes ([0063]).
Regarding claims 15-16, Kandil in view of Beier teaches the method of claim 1 (see rejection above), but is silent to wherein applying thermal energy comprises applying the thermal energy until a stress retention within the aligner increases at least 10% or wherein applying thermal energy comprises applying the thermal energy until a force recovery within the aligner increases at least 10%.
Kandil teaches the appliance is heated to prevent unwanted creep and achieve alignment of polymer chains, leading to a lower stress relaxation ([0063-0065]). Kandil also mentions that in some cases, less than 90% of the starting position of 4D materials is reached ([0043-0044]). This indicates that when heat is applied to the aligner, the materials polymer chains align and regain some of its force and since stress relaxation is lowered, stress retention increases. Kandil states that in some cases, partial repetition of steps can achieve better progress ([0019]-[0023]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to have thermal energy be applied until at least 10% of the material’s stress retention and force recovery is achieved since it would allow the heated aligner to apply the forces required to move the teeth, which Kandil acknowledges would repeat some of the forces applied by the aligner before heating and improve progress.
Regarding claim 17, Kandil in view of Beier teaches the method of claim 1 (see rejection above). Kandil teaches wherein the aligner comprises a PETG co-polymer material ([0030]).
Regarding claim 19, Kandil teaches a method of regenerating a force within an aligner ([0005], [0033], [0037]), comprising: forming an aligner ([0005]; an aligner is provided and therefore is formed); and
applying thermal energy to the aligner such that the aligner is maintained at a predetermined temperature for a predetermined period of time ([0060-0065]).
Kandil teaches heating an aligner to change its form. Kandil teaches when the second device is heated, the device introduces a second temporary form (and possibly further temporary forms) and finally the final shape such that the first temporary form of said device matches the final form of the first correction device ([0037-0041]). Kandil discusses that repeating a correction device a higher degree of accuracy is achieved by the orthodontic procedure ([0045]). Therefore, Kandil’s teachings indicate that the second aligner is heated as to achieve a final form of a previous aligner (i.e. an initial form).
Kandil does not explicitly teach the initial form of the aligner is a form prior to use by the patient to apply a sustained level of force, such that the aligner regains its initial form after use by the patient and regenerates to apply the sustained level of force.
Beier discusses that an aligner becomes deformed and with the changed shape, it loses its orthodontic force and further teaches placing the aligner in hot water as to restore its original shape. Beier teaches that this eliminates the need for replacing the aligner and additionally helps with making aligner placement less painful for the patient and disinfects the aligner (see paragraphs 2-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Kandil to involve explicitly returning the aligner form to a form prior to patient use, as discussed by Beier, because it would be applicable for repeating movements at a stage (i.e., restoring forces) as needed to achieve desired and accurate repositioning, which Kandil contemplates, without the need for an additional/repetitive aligner in between stages.
Regarding claim 20, Kandil in view of Beier teaches the method of claim 19 (see rejection above). Kandil teaches the aligner is made of PETG ([0030]) and a three-dimensional model is used to produce the final shape of the device ([0050-0055]), but is silent to it being thermoformed. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the aligner be thermoformed, such that it is well known in the art that PETG is a commonly thermoformed thermoplastic material.
Regarding claim 21, Kandil in view of Beier teaches the method of claim 19 (see rejection above). Kandil teaches it further comprising receiving the aligner within a receptacle post-use by a patient 0005], [0033], [0037], [0075]; a plastic aligner is put in a water bath to assume a second temporary shape as to provide a second form for the same stage aligner for more effective and accurate repositioning).
Regarding claim 22, Kandil in view of Beier teaches the method of claim 21 (see rejection above). Kandil teaches wherein receiving the aligner comprises immersing the aligner within a container filled with a fluid ([0033], [0065]).
Regarding claim 23, Kandil in view of Beier teaches the method of claim 22 (see rejection above). Kandil tecahes wherein the fluid comprises water, aqueous solution, organic solvent, or any combination thereof ([0033], [0065]).
Regarding claim 26, Kandil in view of Beier teaches the method of claim 19 (see rejection above). Kandil teaches wherein applying thermal energy comprises applying an energy modality comprising electrical, hydrothermal ([0033], [0065]; water and/or heat can be used and therefore hydrothermal energy is applied), ultrasonic, radiative, electromagnetic, ultraviolet, infrared, or chemical heating.
Regarding claim 30, Kandil in view of Beier teaches the method of claim 19 (see rejection above). Kandil teaches wherein applying thermal energy comprises maintaining the aligner at the predetermined period of time of 1-5 minutes ([0063]).
Regarding claims 32-33, Kandil in view of Beier teaches the method of claim 19 (see rejection above), but is silent to wherein applying thermal energy comprises applying the thermal energy until a stress retention within the aligner increases at least 10% or wherein applying thermal energy comprises applying the thermal energy until a force recovery within the aligner increases at least 10%.
Kandil teaches the appliance is heated to prevent unwanted creep and achieve alignment of polymer chains, leading to a lower stress relaxation ([0063-0065]). Kandil also mentions that in some cases, less than 90% of the starting position of 4D materials is reached ([0043-0044]). This indicates that when heat is applied to the aligner, the materials polymer chains align and regain some of its force and since stress relaxation is lowered, stress retention increases. Kandil states that in some cases, partial repetition of steps can achieve better progress ([0019]-[0023]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to have thermal energy be applied until at least 10% of the material’s stress retention and force recovery is achieved since it would allow the heated aligner to apply the forces required to move the teeth, which Kandil acknowledges would repeat some of the forces applied by the aligner before heating and improve progress.
Regarding claim 34, Kandil in view of Beier teaches the method of claim 19 (see rejection above). Kandil teaches wherein the aligner comprises a PETG co-polymer material ([0030]).
Regarding claim 43, Kandil teaches an apparatus comprising: an aligner which is configured to apply a sustained level of force upon one or more teeth of a patient during use by the patient ([0005]), wherein the aligner is exposed to heat for more than 10 minutes prior to use by a patient such that a stress retention and a stress force within the aligner increases prior to exposure of the heat ([0060-0065]).
Kandil teaches the aligner is made of PETG ([0030]) and a three-dimensional model is used to produce the final shape of the device ([0050-0055]), but is silent to it being thermoformed. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the aligner be thermoformed, such that it is well known in the art that PETG is a commonly thermoformed thermoplastic material.
Kandil teaches heating an aligner to change its form. Kandil teaches when the second device is heated, the device introduces a second temporary form (and possibly further temporary forms) and finally the final shape such that the first temporary form of said device matches the final form of the first correction device ([0037-0041]). Kandil discusses that repeating a correction device a higher degree of accuracy is achieved by the orthodontic procedure ([0045]). Therefore, Kandil’s teachings indicate that the second aligner is heated as to achieve a final form of a previous aligner (i.e. an initial form).
Kandil does not explicitly teach heating to explicitly return the aligner from a degraded level of force after use by the patient back to the sustained level of force.
Beier discusses that an aligner becomes deformed and with the changed shape, it loses its orthodontic force and further teaches placing the aligner in hot water as to restore its original shape. Beier teaches that this eliminates the need for replacing the aligner and additionally helps with making aligner placement less painful for the patient and disinfects the aligner (see paragraphs 2-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Kandil to involve explicitly returning the aligner form to a form prior to patient use, as discussed by Beier, because it would be applicable for repeating movements at a stage (i.e., restoring forces) as needed to achieve desired and accurate repositioning, which Kandil contemplates, without the need for an additional/repetitive aligner in between stages.
Claim(s) 10-12, 27-29, 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Connell et al. (US 2021/0177549 A1).
Regarding claims 10-12, Kandil in view of Beier teaches the method of claim 1 (see rejection above). Kandil teaches the device is heated to a temperature below the material-specific glass transition temperature of below the material-specific critical temperature ([0060-0065]) and the material of the aligner is PETG ([0030]), but is silent to explicitly wherein the temperature of the heat is between 50°-100° C, up to 80° C, or up to 95° C.
Connell et al. teaches a device in the same field of endeavors of dental aligners. Connell teaches the aligner is made of a thermoformable material such as PETG having a glass transition temperature of 178° F (81.1° C) ([0103]). Connell teaches different polymeric materials having a variety of glass transition temperatures including temperatures of at least 30°, 35°, 40°, 45°, 50°, 55°, or 60° C and no greater than 100°, 95°, 90°, 85°, 80°, or 75° C ([0107]).
It would have been obvious to one having ordinary skill in the art to modify the temperature to be between 30° C and 100° C, because as taught by Connell, the glass transition temperatures of polymeric materials including PETG fall within said range.
Regarding claims 27-29, Kandil in view of Beier teaches the method of claim 19 (see rejection above). Kandil teaches the device is heated to a temperature below the material-specific glass transition temperature of below the material-specific critical temperature ([0060-0065]) and the material of the aligner is PETG ([0030]), but is silent to explicitly wherein the temperature of the heat is between 50°-100° C, up to 80° C, or up to 95° C.
Connell et al. teaches a device in the same field of endeavors of dental aligners. Connell teaches the aligner is made of a thermoformable material such as PETG having a glass transition temperature of 178° F (81.1° C) ([0103]). Connell teaches different polymeric materials having a variety of glass transition temperatures including temperatures of at least 30°, 35°, 40°, 45°, 50°, 55°, or 60° C and no greater than 100°, 95°, 90°, 85°, 80°, or 75° C ([0107]).
It would have been obvious to one having ordinary skill in the art to modify the temperature to be between 30° C and 100° C, because as taught by Connell, the glass transition temperatures of polymeric materials including PETG fall within said range.
Regarding claim 44, Kandil in view of Beier teaches the apparatus of claim 43 (see rejection above). Kandil teaches the device is heated to a temperature below the material-specific glass transition temperature of below the material-specific critical temperature ([0060-0065]) and the material of the aligner is PETG ([0030]), but is silent to explicitly wherein the temperature of the heat is between 50°-100° C.
Connell et al. teaches a device in the same field of endeavors of dental aligners. Connell teaches the aligner is made of a thermoformable material such as PETG ([0100]) and the glass transition temperature for said PETG is 178 ̊F ([0103]), which is equivalent to 81.1 ̊C.
It would have been obvious to one having ordinary skill in the art to modify the temperature to be between less than 81.1 ̊C, because as taught by Connell, the glass transition temperature of PETG material may be 81.1 ̊C.
Claim(s) 4, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Nelson (US 2,473,723).
Regarding claim 4, Kandil in view of Beier teaches the method of claim 3 (see rejection above), but is silent to wherein the organic solvent comprises polyglycol or glycerine.
Nelson teaches a method of making an artificial prosthesis (Col. 1 l. 6-13) and using any suitable material (Col. 3 l. 12-28). Nelson teaches glycerine or another suitable liquid can be heated and used as a bath (Col. 5 l. 49-75). Nelson further teaches water may be used as a bath to reduce surface tension (Col. 9 l. 62-68).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the solution to include glycerine or water, since said modification can be heated to cause a reaction in the material of the prosthesis/appliance. It would have been an obvious matter of design choice to select a material suitable for the heated bath depending on the material used for the device as it would have involved a mere change that is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 24, Kandil in view of Beier teaches the method of claim 23 (see rejection above), but is silent to wherein the organic solvent comprises polyglycol or glycerine.
Nelson teaches a method of making an artificial prosthesis (Col. 1 l. 6-13) and using any suitable material (Col. 3 l. 12-28). Nelson teaches glycerine or another suitable liquid can be heated and used as a bath (Col. 5 l. 49-75). Nelson further teaches water may be used as a bath to reduce surface tension (Col. 9 l. 62-68).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the solution to include glycerine or water, since said modification can be heated to cause a reaction in the material of the prosthesis/appliance. It would have been an obvious matter of design choice to select a material suitable for the heated bath depending on the material used for the device as it would have involved a mere change that is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Sachdeva (US 2020/0060797 A1).
Regarding claims 5-6, Kandil in view of Beier teaches the method of claim 1 (see rejection above), but is silent to wherein receiving the aligner comprises applying a cleaning or oxidizing agent, a mouth freshening agent or oil upon the aligner.
Sachdeva teaches an aligner and applying a material including a peroxide, or an essential oil or a material to control bad breath and inflammation to the aligner ([0074]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include applying an oxidizing agent, or a breath freshening oil to the aligner, as taught by Sachdeva, as it would provide the aligner with cleaning, whitening or bleaching and odor eliminating properties.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Ibsen et al. (US 2006/0107963 A1).
Regarding claims 7, Kandil in view of Beier teaches the method of claim 1 (see rejection above), but is silent to wherein receiving the aligner comprises immersing the aligner into an antibacterial agent.
Ibsen teaches a dental appliance/nightguard that submerged in a small amount of anti-bacterial mouthwash between uses ([0013]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include submerging the appliance in an antibacterial agent, as taught by Ibsen, as it would clean the appliance between uses and prevent bacteria or microbes from accumulating on the appliance.
Claim(s) 8, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Sato et al. (US 20200390523 A1).
Regarding claim 8, Kandil in view of Beier teaches the method of claim 1 (see rejection above), but is silent to wherein receiving the aligner further comprises measuring a force imparted by the aligner upon one or more pressure sensors.
Sato teaches an appliance receptacle or case (310) having a tray (312) into which the appliance (106) is received (see Figures 3A-3B). Sato teaches the case may include a pressure sensor to detect whether the dental appliance is on the tray by detecting an expected weight and/or surface area of contact ([0009], [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the method to include measuring a force/weight applied by the appliance on a pressure sensor, as taught by Sato, since such modification would allow the user to ensure that the device is placed in the receptacle for heating.
Regarding claim 25, Kandil in view of Beier teaches the method of claim 21 (see rejection above), but is silent to wherein receiving the aligner further comprises measuring a force imparted by the aligner upon one or more pressure sensors.
Sato teaches an appliance receptacle or case (310) having a tray (312) into which the appliance (106) is received (see Figures 3A-3B). Sato teaches the case may include a pressure sensor to detect whether the dental appliance is on the tray by detecting an expected weight and/or surface area of contact ([0009], [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the method to include measuring a force/weight applied by the appliance on a pressure sensor, as taught by Sato, since such modification would allow the user to ensure that the device is placed in the receptacle for heating.
Regarding claim 39, Kandil in view of Beier teaches the method of claim 36 (see rejection above), but is silent to wherein the receptacle further comprises one or more pressure sensors for contacting the aligner.
Sato teaches an appliance receptacle or case (310) having a tray (312) into which the appliance (106) is received (see Figures 3A-3B). Sato teaches the case may include a pressure sensor to detect whether the dental appliance is on the tray by detecting an expected weight and/or surface area of contact ([0009], [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the receptacle to include a pressure sensor for detecting a force/weight applied by the appliance, as taught by Sato, since such modification would allow the user to ensure that the device is placed in the receptacle for heating.
Claim(s) 14, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Pierson et al. (US 2010/0167230 A1).
Regarding claim 14, Kandil in view of Beier teaches the method of claim 1 (see rejection above), but is silent to wherein applying thermal energy comprises placing an exothermic reactant into water and in thermal communication with the aligner.
Pierson teaches heating a dental material using a heat pack containing reactants for an exothermic chemical reaction ([0010]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include using an exothermic reaction to heat the water, as taught by Pierson, as it would allow heating the liquid to an orally safe temperature.
Regarding claim 31, Kandil in view of Beier teaches the method of claim 19 (see rejection above), but is silent to wherein applying thermal energy comprises placing an exothermic reactant into water and in thermal communication with the aligner.
Pierson teaches heating a dental material using a heat pack containing reactants for an exothermic chemical reaction ([0010]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include using an exothermic reaction to heat the water, as taught by Pierson, as it would allow heating the liquid to an orally safe temperature.
Claim(s) 18, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of Beier (NPL, 2021; Graphy presents first direct 3D-printed aligner), and further in view of Kandil (DE102019109807A1), translation provided and henceforth referred to as Kandil 2.
Regarding claim 18, Kandil in view of Beier teaches the method of claim 1 (see rejection above), but is silent to it further comprising monitoring the aligner within the receptacle via a controller.
Kandil 2 teaches a receptacle for heating an orthodontic correction device (abstract) wherein the receptacle comprises a heating source such as an electric heater to heat the liquid medium to a specified temperature, which is below the glass transition temperature (see page 4 paragraph 2). Kandil 2 teaches the receptacle comprises a control unit with a panel having switches, an input device and display device such that one can input and control parameters including temperature levels and time. Kandil 2 further teaches the control unit may be connected to external means for monitoring and controlling the function of the device, for example a smartphone (see page 5 paragraphs 3-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include monitoring the aligner (e.g., by monitoring time and levels, which the device is undergoing) via a controller and displays, as taught by Kandil 2, since it would be advantageous to be able to control and set or adjust the conditions applied to the aligner as to not overheat or ruin it.
Regarding claim 35, Kandil in view of Beier teaches the method of claim 19 (see rejection above), but is silent to it further comprising monitoring the aligner within the receptacle via a controller.
Kandil 2 teaches a receptacle for heating an orthodontic correction device (abstract) wherein the receptacle comprises a heating source such as an electric heater to heat the liquid medium to a specified temperature, which is below the glass transition temperature (see page 4 paragraph 2). Kandil 2 teaches the receptacle comprises a control unit with a panel having switches, an input device and display device such that one can input and control parameters including temperature levels and time. Kandil 2 further teaches the control unit may be connected to external means for monitoring and controlling the function of the device, for example a smartphone (see page 5 paragraphs 3-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include monitoring the aligner (e.g., by monitoring time and levels, which the device is undergoing) via a controller and displays, as taught by Kandil 2, since it would be advantageous to be able to control and set or adjust the conditions applied to the aligner as to not overheat or ruin it.
Claim(s) 36-38, 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of in view of Kandil (DE102019109807A1), translation provided and henceforth referred to as Kandil 2.
Regarding claim 36, Kandil teaches an aligner apparatus configured to regenerate a force ([0005], [0033], [0037], [0075]), comprising:
an aligner having an initial form which is configured to correct a malocclusion of a patient dentition ([0005]), wherein the aligner is formed of a PETG co-polymer ([0030]); and
a receptacle configured for receiving the aligner and applying thermal energy to the aligner such that the aligner is maintained at a predetermined temperature for a predetermined period of time by the receptacle ([0060-0065]).
Kandil is silent to a controller in communication with the receptacle and configured to maintain the receptacle at the predetermined temperature for the predetermined period of time, wherein the predetermined temperature and predetermined period of time are correlated to the aligner for regaining the initial form of the aligner and for regenerating stress forces within the aligner lost from use by a patient.
Kandil 2 teaches a receptacle for heating an orthodontic correction device (abstract) wherein the receptacle comprises a heating source such as an electric heater to heat the liquid medium to a specified temperature, which is below the glass transition temperature (see page 4 paragraph 2). Kandil 2 teaches the receptacle comprises a control unit with a panel having switches, an input device and display device such that one can input and control parameters including temperature levels and time. Kandil 2 further teaches the control unit may be connected to external means for monitoring and controlling the function of the device, for example a smartphone (see page 5 paragraphs 3-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include monitoring the aligner (e.g., by monitoring time and levels, which the device is undergoing) via a controller and displays, as taught by Kandil 2, since it would be advantageous to be able to control and set or adjust the conditions applied to the aligner as to not overheat or ruin it.
Kandil teaches heating an aligner to change its form. Kandil teaches when the second device is heated, the device introduces a second temporary form (and possibly further temporary forms) and finally the final shape such that the first temporary form of said device matches the final form of the first correction device ([0037-0041]). Kandil discusses that repeating a correction device a higher degree of accuracy is achieved by the orthodontic procedure ([0045]). Therefore, Kandil’s teachings indicate that the second aligner is heated as to achieve a final form of a previous aligner (i.e. an initial form) and is fully capable of returning it to a shape prior to use by a patient.
Regarding claim 37, Kandil in view of Kandil 2 teaches the apparatus of claim 36 (see rejection above). Kandil teaches wherein the receptacle comprises a water bath ([0065]).
Regarding claim 38, Kandil in view of Kandil 2 teaches the apparatus of claim 36 (see rejection above). Kandil 2 teaches wherein the receptacle further comprises a heating element (see page 4 paragraph 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the receptacle to include a heating source, as taught by Kandil 2, as it would provide convenient and built-in means for heating the water into which the aligner is placed.
Regarding claims 41, Kandil in view of Kandil 2 teaches the apparatus of claim 36 (see rejection above). Kandil 2 teaches it further comprising a display in communication with the controller.
Kandil 2 teaches a receptacle for heating an orthodontic correction device (abstract) wherein the receptacle comprises a heating source such as an electric heater to heat the liquid medium to a specified temperature, which is below the glass transition temperature (see page 4 paragraph 2). Kandil 2 teaches the receptacle comprises a control unit with a panel having switches, an input device and display device such that one can input and control parameters including temperature levels and time. Kandil 2 further teaches the control unit may be connected to external means for monitoring and controlling the function of the device, for example a smartphone (see page 5 paragraphs 3-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method to include monitoring the aligner (e.g., by monitoring time and levels, which the device is undergoing) via a controller and displays, as taught by Kandil 2, since it would be advantageous to be able to control and set or adjust the conditions applied to the aligner as to not overheat or ruin it.
Regarding claim 42, Kandil in view of Kandil 2 teaches the apparatus of claim 36 (see rejection above). Kandil 2 teaches the controller further configured to be in wireless communication with an external device (see page 5 paragraph 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the device to have wireless communication with the controller of the receptacle, as taught by Kandil 2, since it would allow convenient control of the device and its settings.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kandil (WO2020239429A1), translation provided, in view of in view of Kandil (DE102019109807A1), translation provided and henceforth referred to as Kandil 2, and further in view of Sato et al. (US 20200390523 A1).
Regarding claim 39, Kandil in view of Kandil 2 teaches the method of claim 36 (see rejection above), but is silent to wherein the receptacle further comprises one or more pressure sensors for contacting the aligner.
Sato teaches an appliance receptacle or case (310) having a tray (312) into which the appliance (106) is received (see Figures 3A-3B). Sato teaches the case may include a pressure sensor to detect whether the dental appliance is on the tray by detecting an expected weight and/or surface area of contact ([0009], [0053]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the receptacle to include a pressure sensor for detecting a force/weight applied by the appliance, as taught by Sato, since such modification would allow the user to ensure that the device is placed in the receptacle for heating.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-39, 41-44 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/LINA FARAJ/ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
1/22/2026