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 .
Response to Amendment
The amendments made to claims 1, 7, 13, and 18 in the response filed 2/3/26 are acknowledged.
Claims 1-21 are still pending in the application and are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-21 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 (new reference Liptak is relied upon for the newly added limitations in the claims).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 and 18-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim recites the limitation “wherein a first side and a second side of each of the upper protrusion and lower protrusion” in lines 34-35. It is unclear whether the first and second sides of the upper protrusion recited here are the same or different from the first and second sides of the upper protrusion recited in lines 21-22. Though they use the same terminology for the upper protrusion (first and second sides), the lower protrusion uses different terminology (first and second sides vs. third and fourth sides), making it unclear what the Applicant’s intention is. For purposes of compact prosecution and examination, the first and second sides of the upper protrusion in lines 21-22 and 34-35 are interpreted to be the same features.
Regarding claim 18, the claim recites the limitation “wherein a first side and a second side of each of the upper protrusion and lower protrusion” in lines 32-33. It is unclear whether the first and second sides of the upper protrusion recited here are the same or different from the first and second sides of the upper protrusion recited in lines 21-22. Though they use the same terminology for the upper protrusion (first and second sides), the lower protrusion uses different terminology (first and second sides vs. third and fourth sides), making it unclear what the Applicant’s intention is. For purposes of compact prosecution and examination, the first and second sides of the upper protrusion in lines 21-22 and 32-33 are interpreted to be the same features.
Regarding claims 2-6 and 19-21, the claims are rejected under 35 U.S.C. 112(b) by virtue of their dependence on claims 1 and 18.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-12, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liptak et al. US 2016/0184129 A1 in view of Quaka et al. US 2014/0326252 A1.
Regarding claim 1, Liptak discloses an oral device 100 (figs. 1A/B and [0027], mandibular advancement device 100) with protrusions 114/116 (figs. 2A/B and [0030]-[0031], upper splint 102 has at least one upper fin 114, and lower splint 104 has at least one lower fin 116) comprising:
an upper tray assembly 102, including an upper bracket, and having an arcuate outer shape configured to conform to a curvature of a patient’s upper dental arch 106 (figs. 1A/B and 2A/B and [0027], upper splint 102 snuggly fits onto the upper dentition 106; the term “splint” indicates that the upper tray/splint 102 provides a degree of structure and rigidity, making it a bracket);
a lower tray assembly 104, including a lower bracket, and having an arcuate outer shape configured to conform to a curvature of the patient’s lower dental arch (figs. 1A/B and 2A/B and [0027], lower splint 104 snuggly fits onto the lower dentition 108; the term “splint” indicates that the lower tray/splint 104 provides a degree of structure and rigidity, making it a bracket);
wherein the upper bracket 102 and the lower bracket 104 each are formed by an outer wall and a bottom wall (annotated fig. A below, the outer wall being the buccal/labial wall of the trays 102/104, and the bottom wall being the occlusal wall of each tray), each having two opposite sides configured to be near cheeks when in use (annotated fig. A below, the opposite sides being the legs of the U-shaped trays 102/104 having protrusions 114/116), wherein the oral device 100 has an end point configured to be positioned away from a lip side (annotated fig. A, the end points of each tray being the tips facing the inside of the mouth when worn);
wherein the upper bracket 102 and the lower bracket 104 each have at least one side of the two opposite sides configured to be near the cheeks that includes an upper protrusion 114 and a lower protrusion 116, respectively (annotated fig. A, the upper protrusions 114 and lower protrusions 116 being on the sides of each bracket 102/104), and wherein the upper protrusion 114 and the lower protrusion 116 are configured to allow the patient’s mouth to open and close while maintaining a fixed anterior-posterior positional relationship between the upper bracket 102 and the lower bracket 104 when in use ([0034], the relative forward position of the upper and lower jaws is fixed while allowing the patient to open and close their mouth);
wherein the upper protrusion 114 has a first side nearer the end point and a second side opposite the first side, wherein the lower protrusion 116 has a third side nearer the end point and a fourth side opposite the third side (annotated fig. A), and wherein the second side and the third side are configured to be in contact when in use to limit a distance of an anterior displacement of the lower bracket 104 (figs. 1B and annotated fig. A, and [0034], the contact between the front surface 202 of the upper fin 114 and the back surface 204 of the lower fin 116 prevents the lower jaw from moving backward);
wherein the upper protrusion 114 and the lower protrusion 116 each have at least a portion configured to be positioned nearer the cheeks than the outer walls of the upper bracket 102 and the lower bracket 104 (figs. 2A/B, the protrusions 114/116 protrude outward from the outer walls of their respective trays 102/104 and would thus be nearer to the cheeks when worn);
wherein a distance from the upper protrusion 114 to the end point of the oral device 100 is shorter than a distance from the lower protrusion 116 to the end point of the oral device 100 (annotated fig. A, the upper protrusion 114 being closer to the end point than the lower protrusion 116, which is more anterior);
wherein the upper protrusion 114 extends in a first direction past the bottom wall of the upper bracket 102 toward the lower bracket 104 to overlap the lower bracket 104 in a second direction and the lower protrusion 116 extends in the first direction past the bottom wall of the lower bracket 104 towards the upper bracket 102 and overlaps the upper bracket 102 in the second direction (fig. 1B, each protrusion 114/116 extends vertically (first direction) past the occlusal wall of their respective trays to overlap the opposite tray in the vertical direction; thus, the protrusions 114/116 overlap each other in the buccal-lingual direction (second direction), since their contacting surfaces overlap in the thickness direction),
wherein a first side and a second side of each of the upper protrusion 114 and lower protrusion 116 extend outwardly in the second direction from the outer walls of the upper bracket 102 and lower bracket 104, respectively, and an inner wall and an outer wall extend between the first side and the second side (annotated fig. B below, each protrusion having first and second sides that extend outwardly in the buccal direction from the outer wall of the respective tray, and each protrusion has an inner wall facing lingually and an outer wall facing buccally),
wherein the upper tray assembly 102 and lower tray assembly 104 are stacked in a vertical direction (figs. 1A/B), and
wherein the upper protrusion 114 and the lower protrusion 116 form an angle with an axis extending in the vertical direction (annotated fig. C below, the upper and lower protrusion 114/116 both forming an angled edge relative to the vertical direction).
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Liptak is silent on the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket.
However, Quaka teaches an analogous oral device 1 (fig. 1 and [0026], sleep apnea device for advancement of mandible) comprising an upper tray assembly 2/18 (fig. 1 and [0042], upper tray 2 for locating of the maxillary teeth therein; figs. 6-9 and [0047], acrylic liner material 18 within the tray 2) including an upper moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); a lower tray assembly 3 (fig. 1 and [0043], mandibular tray 3; figs. 6-9 and [0047], acrylic liner material 18 within the tray 3) including a lower moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket 2, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket 3 (fig. 9 and [0048], the acrylic liner that receives the impression lines the bottom wall of the respective trays 2/3), and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket 2 and the lower bracket 3 (figs. 6-9 and [0047], heat is applied to the acrylic liner laden or filled tray, such that the teeth can form an impression in the liner; as can be seen in the figures, the liner 18 molds to the shape of the teeth while the bracket 2 (or 3) stays the same; therefore, even though heat was applied to both the liner and bracket at the same time, the bracket was not made moldable, indicating a lower deformation temperature than the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral device of Liptak with the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket, as taught by Quaka, to provide a simple way for users to highly customize the trays to their teeth.
Regarding claim 2, Liptak in view of Quaka discloses the claimed invention as discussed above.
Liptak further discloses the arcuate outer shapes of the upper tray assembly 102 and the lower tray assembly 104 adopt at least one of an ovoid arch, a tapered arch (figs. 2A/B), or a square arch.
Regarding claim 3, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches a material of the upper moldable component 18 and the lower moldable component 18 including a flexible thermoplastic material ([0019], polycaprolactone polymer (which is thermoplastic) receives the indentation of the patient’s teeth), to mold appropriately to the shape of the user’s teeth for customization.
Regarding claim 4, Liptak in view of Quaka further in view of Norton discloses the claimed invention as discussed above.
Quaka further teaches the upper moldable component 18 and the lower moldable component 18 being configured to soften when heated in hot water, and to allow them to be adjusted and molded to match the curvatures of the patient’s upper dental arch and lower dental arch during biting (figs. 6-9 and [0047], heat is applied to the liner filled trays, such that the teeth can form an impression in the liner; [0019], the liner material may soften in water), to provide a convenient and simple way for patients to customize their tray.
Regarding claim 5, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches a hardness of a material of the upper bracket 2 and the lower bracket 3 being at least partially greater than a hardness of a material of the upper moldable component 18 and the lower moldable component 18 (figs. 6-8 and [0019], during molding, the hardness of the liner 18 is softer than the frames 2/3, which maintain their shape), to provide structure to the moldable material during customization so that it does not lose integrity.
Regarding claim 6, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches the connection between the upper moldable component 18 and the bottom wall of the upper bracket 2, and between the lower moldable component 18 and the bottom wall of the lower bracket 3, being established through one of the following methods: snap-fit connection, adhesive bonding, or groove connection (figs. 6-9 illustrate how the moldable acrylic liner settles into and lines the groove/channel of the respective tray, forming a groove connection), to more securely hold the liner within the respective tray.
Regarding claim 7, Liptak discloses an oral device 100 (figs. 1A/B and [0027], mandibular advancement device 100) with protrusions 114/116 (figs. 2A/B and [0030]-[0031], upper splint 102 has at least one upper fin 114, and lower splint 104 has at least one lower fin 116) comprising:
an upper tray assembly 102, including an upper bracket, configured to be positioned adjacent to a patient’s upper dental arch 106 when configured to be placed inside the patient’s mouth (figs. 1A/B and 2A/B and [0027], upper splint 102 snuggly fits onto the upper dentition 106; the term “splint” indicates that the upper tray/splint 102 provides a degree of structure and rigidity, making it a bracket);
a lower tray assembly 104, including a lower bracket, configured to be positioned adjacent to the patient’s lower dental arch 108 when configured to be placed inside the patient’s mouth (figs. 1A/B and 2A/B and [0027], lower splint 104 snuggly fits onto the lower dentition 108; the term “splint” indicates that the lower tray/splint 104 provides a degree of structure and rigidity, making it a bracket);
wherein the upper bracket 102 and the lower bracket 104 each are formed by an outer wall and a bottom wall (annotated fig. A, the outer wall being the buccal/labial wall of the trays 102/104, and the bottom wall being the occlusal wall of each tray), each having two opposite sides configured to be near cheeks when in use (annotated fig. A, the opposite sides being the legs of the U-shaped trays 102/104 having protrusions 114/116), wherein the oral device 100 has an end point configured to be positioned away from a lip side (annotated fig. A, the end points of each tray being the tips facing the inside of the mouth when worn);
wherein the upper bracket 102 and the lower bracket 104 each have at least one side of the two opposite sides configured to be near the cheeks that includes an upper protrusion 114 and a lower protrusion 116, respectively (annotated fig. A, the upper protrusions 114 and lower protrusions 116 being on the sides of each bracket 102/104), and wherein the upper protrusion 114 and the lower protrusion 116 are configured to allow the patient’s mouth to open and close while maintaining a fixed anterior-posterior positional relationship between the upper bracket 102 and the lower bracket 104 when in use ([0034], the relative forward position of the upper and lower jaws is fixed while allowing the patient to open and close their mouth);
wherein the upper protrusion 114 has a first side nearer the end point and a second side opposite the first side, wherein the lower protrusion 116 has a third side nearer the end point and a fourth side opposite the third side (annotated fig. A), and wherein the second side and the third side are configured to be in contact when in use to limit a distance of an anterior displacement of the lower bracket 104 (figs. 1B and annotated fig. A, and [0034], the contact between the front surface 202 of the upper fin 114 and the back surface 204 of the lower fin 116 prevents the lower jaw from moving backward), wherein the second and/or the third side is curved (annotated fig. A, the second side curves outward from the tray 102 and downwardly, and the third side curves upward to form a rounded top edge);
wherein a distance from the upper protrusion 114 to the end point of the oral device 100 is shorter than a distance from the lower protrusion 116 to the end point of the oral device 100 (annotated fig. A, the upper protrusion 114 being closer to the end point than the lower protrusion 116, which is more anterior);
wherein the upper protrusion 114 extends in a first direction past the bottom wall of the upper bracket 102 toward the lower bracket 104 to overlap the lower bracket 104 in a second direction and the lower protrusion 116 extends in the first direction past the bottom wall of the lower bracket 104 towards the upper bracket 102 and overlaps the upper bracket 102 in the second direction (fig. 1B, each protrusion 114/116 extends vertically (first direction) past the occlusal wall of their respective trays to overlap the opposite tray in the vertical direction; thus, the protrusions 114/116 overlap each other in the buccal-lingual direction (second direction), since their contacting surfaces overlap in the thickness direction),
wherein the upper tray assembly 102 and lower tray assembly 104 are stacked in a vertical direction (figs. 1A/B),
wherein the upper protrusion 114 and the lower protrusion 116 form an angle with an axis extending in the vertical direction (annotated fig. C, the upper and lower protrusion 114/116 both forming an angled edge relative to the vertical direction), and
wherein the upper protrusion 114 is immovable relative to the upper bracket 102, and the lower protrusion 116 is immovable relative to the lower bracket 104 (fig. 2A and [0034], the abutment of the fins 114/116 prevents the lower jaw from moving backward relative to the upper jaw to fix the positions of the jaws; thus, the upper fin 114 and lower fin 116 must be immovable relative to their respective trays 102/104, otherwise they would not be able to provide this resisting force).
Liptak is silent on the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket.
However, Quaka teaches an analogous oral device 1 (fig. 1 and [0026], sleep apnea device for advancement of mandible) comprising an upper tray assembly 2/18 (fig. 1 and [0042], upper tray 2 for locating of the maxillary teeth therein; figs. 6-9 and [0047], acrylic liner material 18 within the tray 2) including an upper moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); a lower tray assembly 3 (fig. 1 and [0043], mandibular tray 3; figs. 6-9 and [0047], acrylic liner material 18 within the tray 3) including a lower moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket 2, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket 3 (fig. 9 and [0048], the acrylic liner that receives the impression lines the bottom wall of the respective trays 2/3), and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket 2 and the lower bracket 3 (figs. 6-9 and [0047], heat is applied to the acrylic liner laden or filled tray, such that the teeth can form an impression in the liner; as can be seen in the figures, the liner 18 molds to the shape of the teeth while the bracket 2 (or 3) stays the same; therefore, even though heat was applied to both the liner and bracket at the same time, the bracket was not made moldable, indicating a lower deformation temperature than the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral device of Liptak with the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket, as taught by Quaka, to provide a simple way for users to highly customize the trays to their teeth.
Regarding claim 8, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches a distance between at least a portion of the upper protrusion 9/10 and the outer wall of the upper bracket 2 being greater than or equal to a distance between the lower protrusion 12/13 and the outer wall of the lower bracket 3 (please see annotated fig. D, which shows via the arrows the points at which the outer surfaces of the upper protrusions and lower protrusions are flush, such that the distance between the outer surface (the “at least a portion”) of the upper protrusions 9/10 and the outer wall of upper tray 2 is equal to a distance between the outer surface of the lower protrusions 12/13 and the outer wall of the lower tray 3), to prevent irregular surface features that would irritate the inside of the mouth.
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Regarding claim 9, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches the connection between the upper moldable component 18 and the upper bracket 2, and between the lower moldable component 18 and the lower bracket 3, being established through grooves formed by the outer walls and the bottom walls of the upper bracket 2 and the lower bracket 3, respectively (figs. 6-9 illustrate how the moldable acrylic liner settles into and lines the groove/channel formed by the bottom and outer walls of each tray), to more securely hold the liner within the respective tray.
Regarding claim 10, Liptak in view of Quaka discloses the claimed invention as discussed above.
Liptak further discloses the upper protrusion 114 and the lower protrusion 116 having shapes that conform to curvatures of the outer walls of the upper bracket 102 and the lower bracket 104, respectively (fig. 8B shows the upper protrusion 114 extending from the outer surface/wall of the upper tray 102 such that it follows the curvature of the tray 102; fig. 2B shows the lower protrusion 116 extending from the outer surface/wall of the lower tray 104 such that it must follow the curvature of the tray 104 in order to extend integrally/continuously from there).
Regarding claim 11, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches the upper moldable component 18 and the lower moldable component 18 including a material with plasticity, and the temperature required to heat the upper moldable component 18 and the lower moldable component 18 to deform being less than 100 degrees Celsius ([0013], the material may be reheated in 140 degrees F, or 60 degrees C, for resetting, which indicates it plasticity), to provide a way for patients to customize their tray without requiring unsafe temperatures.
Regarding claim 12, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches the upper bracket 2 and the lower bracket 3 including a material with high thermal stability, and the temperature required to heat the upper bracket 2 and the lower bracket 3 to deform being greater than 100 degrees Celsius (figs. 6-9 and [0047], heat is applied to the acrylic liner laden or filled tray, such that the teeth can form an impression in the liner; as can be seen in the figures, the liner 18 molds to the shape of the teeth while the tray 2 (or 3) stays the same; therefore, even though heat was applied to both the liner and tray at the same time, the tray was not made moldable, indicating a lower deformation temperature than the liner, which has a softening temperature of 140 F/60 C as discussed previously), to provide structural integrity to the moldable material during customization.
Regarding claim 18, Liptak discloses an oral device 100 (figs. 1A/B and [0027], mandibular advancement device 100) with protrusions 114/116 (figs. 2A/B and [0030]-[0031], upper splint 102 has at least one upper fin 114, and lower splint 104 has at least one lower fin 116) comprising:
an upper tray assembly 102, including an upper bracket, configured to be positioned adjacent to a patient’s upper dental arch 106 when configured to be placed inside the patient’s mouth (figs. 1A/B and 2A/B and [0027], upper splint 102 snuggly fits onto the upper dentition 106; the term “splint” indicates that the upper tray/splint 102 provides a degree of structure and rigidity, making it a bracket);
a lower tray assembly 104, including a lower bracket, configured to be positioned adjacent to the patient’s lower dental arch 108 when configured to be placed inside the patient’s mouth (figs. 1A/B and 2A/B and [0027], lower splint 104 snuggly fits onto the lower dentition 108; the term “splint” indicates that the lower tray/splint 104 provides a degree of structure and rigidity, making it a bracket);
wherein the upper bracket 102 and the lower bracket 104 each are formed by an outer wall and a bottom wall (annotated fig. A, the outer wall being the buccal/labial wall of the trays 102/104, and the bottom wall being the occlusal wall of each tray), each having two opposite sides configured to be near cheeks when in use (annotated fig. A, the opposite sides being the legs of the U-shaped trays 102/104 having protrusions 114/116), wherein the oral device 100 has an end point configured to be positioned away from a lip side (annotated fig. A, the end points of each tray being the tips facing the inside of the mouth when worn);
wherein the upper bracket 102 and the lower bracket 104 each have at least one side of the two opposite sides configured to be near the cheeks that includes an upper protrusion 114 and a lower protrusion 116, respectively (annotated fig. A, the upper protrusions 114 and lower protrusions 116 being on the sides of each bracket 102/104), and wherein the upper protrusion 114 and the lower protrusion 116 are configured to allow the patient’s mouth to open and close while maintaining a fixed anterior-posterior positional relationship between the upper bracket 102 and the lower bracket 104 when in use ([0034], the relative forward position of the upper and lower jaws is fixed while allowing the patient to open and close their mouth);
wherein the upper protrusion 114 has a first side nearer the end point and a second side opposite the first side, wherein the lower protrusion 116 has a third side nearer the end point and a fourth side opposite the third side (annotated fig. A), and wherein the second side and the third side are configured to be in contact when in use to limit a distance of an anterior displacement of the lower bracket 104 (figs. 1B and annotated fig. A, and [0034], the contact between the front surface 202 of the upper fin 114 and the back surface 204 of the lower fin 116 prevents the lower jaw from moving backward);
wherein the upper bracket 102 and the lower bracket 104 have a front end near the lip side when in use (figs. 2A/B, the front end being the anterior ends of the trays 102/104 forming the curve of the U-shape);
wherein the upper protrusion 114 extends in a first direction past the bottom wall of the upper bracket 102 toward the lower bracket 104 to overlap the lower bracket 104 in a second direction and the lower protrusion 116 extends in the first direction past the bottom wall of the lower bracket 104 towards the upper bracket 102 and overlaps the upper bracket 102 in the second direction (fig. 1B, each protrusion 114/116 extends vertically (first direction) past the occlusal wall of their respective trays to overlap the opposite tray in the vertical direction; thus, the protrusions 114/116 overlap each other in the buccal-lingual direction (second direction), since their contacting surfaces overlap in the thickness direction),
wherein a first side and a second side of each of the upper protrusion 114 and lower protrusion 116 extend outwardly in the second direction from the outer walls of the upper bracket 102 and lower bracket 104, respectively, and an inner wall and an outer wall extend between the first side and the second side (annotated fig. B, each protrusion having first and second sides that extend outwardly in the buccal direction from the outer wall of the respective tray, and each protrusion has an inner wall facing lingually and an outer wall facing buccally),
wherein the upper tray assembly 102 and lower tray assembly 104 are stacked in a vertical direction (figs. 1A/B), and
wherein the upper protrusion 114 and the lower protrusion 116 form an angle with an axis extending in the vertical direction (annotated fig. C, the upper and lower protrusion 114/116 both forming an angled edge relative to the vertical direction).
Regarding Liptak being silent on a distance from the upper protrusion and/or lower protrusion to the front end is greater than 10 mm: according to MPEP 2144.04 IV. A., changes in size/proportion are considered prima facie obvious: “In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” In this case, the only difference between Liptak’s device and the claims is a recitation of the upper protrusion and/or lower protrusion being greater than 10 mm from the front end, and these dimensions would not cause the claimed invention to perform differently than Liptak’s device. Thus, the claimed device is not patentably distinct from Liptak’s device. Further, one of ordinary skill in the art would have been motivated to ensure that the protrusions are greater than 10 mm from the front end of the device so that the device is less visible when worn, and further to provide support to the lower jaw from the rear of the mouth, preventing it from falling backwards.
Liptak is silent on the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket.
However, Quaka teaches an analogous oral device 1 (fig. 1 and [0026], sleep apnea device for advancement of mandible) comprising an upper tray assembly 2/18 (fig. 1 and [0042], upper tray 2 for locating of the maxillary teeth therein; figs. 6-9 and [0047], acrylic liner material 18 within the tray 2) including an upper moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); a lower tray assembly 3 (fig. 1 and [0043], mandibular tray 3; figs. 6-9 and [0047], acrylic liner material 18 within the tray 3) including a lower moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket 2, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket 3 (fig. 9 and [0048], the acrylic liner that receives the impression lines the bottom wall of the respective trays 2/3), and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket 2 and the lower bracket 3 (figs. 6-9 and [0047], heat is applied to the acrylic liner laden or filled tray, such that the teeth can form an impression in the liner; as can be seen in the figures, the liner 18 molds to the shape of the teeth while the bracket 2 (or 3) stays the same; therefore, even though heat was applied to both the liner and bracket at the same time, the bracket was not made moldable, indicating a lower deformation temperature than the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral device of Liptak with the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket, as taught by Quaka, to provide a simple way for users to highly customize the trays to their teeth.
Regarding claim 20, Liptak in view of Quaka discloses the claimed invention as discussed above.
Quaka further teaches the upper tray assembly 2/18 and the lower tray assembly 3/18 including at least two different materials ([0017], the upper and lower trays may be methyl methacrylate; [0019], the linings 18 of the trays 2/3 may be self-curing acrylic such as polycaprolactone polymer), to provide both structure/rigidity while also allowing for customization.
Claim(s) 13, 14, 16, 17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liptak et al. US 2016/0184129 A1 in view of Quaka et al. US 2014/0326252 A1 further in view of Norton US 4,671,766.
Regarding claim 13, Liptak discloses an oral device 100 (figs. 1A/B and [0027], mandibular advancement device 100) with protrusions 114/116 (figs. 2A/B and [0030]-[0031], upper splint 102 has at least one upper fin 114, and lower splint 104 has at least one lower fin 116) comprising:
an upper tray assembly 102, including an upper bracket, and having an arcuate outer shape configured to conform to a curvature of a patient’s upper dental arch 106 (figs. 1A/B and 2A/B and [0027], upper splint 102 snuggly fits onto the upper dentition 106; the term “splint” indicates that the upper tray/splint 102 provides a degree of structure and rigidity, making it a bracket);
a lower tray assembly 104, including a lower bracket, and having an arcuate outer shape configured to conform to a curvature of the patient’s lower dental arch (figs. 1A/B and 2A/B and [0027], lower splint 104 snuggly fits onto the lower dentition 108; the term “splint” indicates that the lower tray/splint 104 provides a degree of structure and rigidity, making it a bracket);
wherein the upper bracket 102 and the lower bracket 104 each are formed by an outer wall and a bottom wall (annotated fig. A, the outer wall being the buccal/labial wall of the trays 102/104, and the bottom wall being the occlusal wall of each tray), each having two opposite sides configured to be near cheeks when in use (annotated fig. A, the opposite sides being the legs of the U-shaped trays 102/104 having protrusions 114/116), wherein the oral device 100 has an end point configured to be positioned away from a lip side (annotated fig. A, the end points of each tray being the tips facing the inside of the mouth when worn);
wherein the upper bracket 102 and the lower bracket 104 each have at least one side of the two opposite sides configured to be near the cheeks that includes an upper protrusion 114 and a lower protrusion 116, respectively (annotated fig. A, the upper protrusions 114 and lower protrusions 116 being on the sides of each bracket 102/104), and wherein the upper protrusion 114 and the lower protrusion 116 are configured to allow the patient’s mouth to open and close while maintaining a fixed anterior-posterior positional relationship between the upper bracket 102 and the lower bracket 104 when in use ([0034], the relative forward position of the upper and lower jaws is fixed while allowing the patient to open and close their mouth);
wherein the upper protrusion 114 has a first side nearer the end point and a second side opposite the first side, wherein the lower protrusion 116 has a third side nearer the end point and a fourth side opposite the third side (annotated fig. A), and wherein the second side and the third side are configured to be in contact when in use to limit a distance of an anterior displacement of the lower bracket 104 (figs. 1B and annotated fig. A, and [0034], the contact between the front surface 202 of the upper fin 114 and the back surface 204 of the lower fin 116 prevents the lower jaw from moving backward);
wherein the upper protrusion 114 extends in a first direction past the bottom wall of the upper bracket 102 toward the lower bracket 104 to overlap the lower bracket 104 in a second direction and the lower protrusion 116 extends in the first direction past the bottom wall of the lower bracket 104 towards the upper bracket 102 and overlaps the upper bracket 102 in the second direction (fig. 1B, each protrusion 114/116 extends vertically (first direction) past the occlusal wall of their respective trays to overlap the opposite tray in the vertical direction; thus, the protrusions 114/116 overlap each other in the buccal-lingual direction (second direction), since their contacting surfaces overlap in the thickness direction),
wherein the upper protrusion 114 and lower protrusion 116 extend outwardly in the second direction from the outer walls of the upper bracket 102 and lower bracket 104, respectively (annotated fig. B, each protrusion having first and second sides that extend outwardly in the buccal direction from the outer wall of the respective tray),
wherein the upper tray assembly 102 and lower tray assembly 104 are stacked in a vertical direction (figs. 1A/B),
wherein the upper protrusion 114 and the lower protrusion 116 form an angle with an axis extending in the vertical direction (annotated fig. C, the upper and lower protrusion 114/116 both forming an angled edge relative to the vertical direction), and
wherein the upper protrusion 114 is immovable relative to the upper bracket 102, and the lower protrusion 116 is immovable relative to the lower bracket 104 (fig. 2A and [0034], the abutment of the fins 114/116 prevents the lower jaw from moving backward relative to the upper jaw to fix the positions of the jaws; thus, the upper fin 114 and lower fin 116 must be immovable relative to their respective trays 102/104, otherwise they would not be able to provide this resisting force).
Liptak is silent on the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket.
However, Quaka teaches an analogous oral device 1 (fig. 1 and [0026], sleep apnea device for advancement of mandible) comprising an upper tray assembly 2/18 (fig. 1 and [0042], upper tray 2 for locating of the maxillary teeth therein; figs. 6-9 and [0047], acrylic liner material 18 within the tray 2) including an upper moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); a lower tray assembly 3 (fig. 1 and [0043], mandibular tray 3; figs. 6-9 and [0047], acrylic liner material 18 within the tray 3) including a lower moldable component 18 (figs. 6-9 and [0047], upper and lower trays 2/3 comprise an acrylic liner that is molded to the teeth following heating when the teeth bite down into it to form an impression); wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket 2, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket 3 (fig. 9 and [0048], the acrylic liner that receives the impression lines the bottom wall of the respective trays 2/3), and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket 2 and the lower bracket 3 (figs. 6-9 and [0047], heat is applied to the acrylic liner laden or filled tray, such that the teeth can form an impression in the liner; as can be seen in the figures, the liner 18 molds to the shape of the teeth while the bracket 2 (or 3) stays the same; therefore, even though heat was applied to both the liner and bracket at the same time, the bracket was not made moldable, indicating a lower deformation temperature than the liner).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the oral device of Liptak with the upper tray assembly including an upper moldable component; the lower tray assembly including a lower moldable component; wherein the upper moldable component is configured to be in connection with at least the bottom wall of the upper bracket, wherein the lower moldable component is configured to be in connection with at least the bottom wall of the lower bracket, and wherein a temperature required to heat the upper moldable component and the lower moldable component to deform is different from that required for the upper bracket and the lower bracket, as taught by Quaka, to provide a simple way for users to highly customize the trays to their teeth.
Liptak in view of Quaka is silent on wherein the upper protrusion and the lower protrusion have one or more of the following characteristics: (a) a height of the upper protrusion and the lower protrusion being between 1.7 mm to 22.5 mm; (b) a distance from the upper protrusion and the lower protrusion and b. a distance from the upper protrusion and the lower protrusion to the outer walls of the upper bracket and the lower bracket, respectively, being less than 17.5 mm.
However, Norton teaches analogous dental trays 2/3 (fig. 4 and col. 1, lines 56-58) comprising an analogous protrusion 5/6 (fig. 4 and col. 2, lines 11-12 and 29-31) having (a) a height of between 1.7 mm to 22.5 mm (col. 2, lines 39-42, 3-12 mm height).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper protrusion and the lower protrusion of Liptak in view of Quaka to have (a) a height of between 1.7 mm to 22.5 mm, as taught by Norton, to provide an adequate fit within the oral cavity.
Regarding claim 14, Liptak in view of Quaka further in view of Norton discloses the claimed invention as discussed above.
Quaka further teaches the upper tray assembly 2/18 and the lower tray assembly 3/18 each being shaped such that a middle is higher than both sides (please see annotated fig. E; the middle portion of the trays 2/3 are in the middle of the dental arch when worn, while the side portion of the trays 2/3 are on the posterior sides of the dental arch when worn; as can be seen in the annotated figure, the trays 2/3 have a greater height in their respective middle portions compared to in the side portions, illustrated by the double arrows), so as not to crowd the back of the oral cavity when worn.
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Regarding claim 16, Liptak in view of Quaka further in view of Norton discloses the claimed invention as discussed above.
Liptak further discloses the outer walls of the upper bracket 102 and the lower bracket 104 having a continuous curvature (annotated fig. A).
Regarding claim 17, Liptak in view of Quaka further in view of Norton discloses the claimed invention as discussed above.
Liptak further discloses a connection point A/B of the upper protrusion 114 and the upper bracket 102, and/or of the lower protrusion 116 and the lower bracket 104, is flush with the bottom walls of the upper bracket 102 and the lower bracket 104 (annotated fig. F, the connection points A and B are flush with and on the same level as the bottom walls of their respective trays 102/104).
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Regarding claim 19, Liptak in view of Quaka discloses the claimed invention as discussed above.
Liptak in view of Quaka is silent on a width of the upper protrusion and the lower protrusion being greater than 2.5 mm.
However, Norton teaches analogous dental trays 2/3 (fig. 4 and col. 1, lines 56-58) comprising an analogous protrusion 5/6 (fig. 4 and col. 2, lines 11-12 and 29-31), wherein a width of the analogous protrusion 5/6 is greater than 2.5 mm (col. 2, lines 39-40, the thickness of the phalanges 5/6 are 1.5-5 mm, where the thickness is being interpreted as the “width”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper protrusion and the lower protrusion of Liptak in view of Quaka to have a width greater than 2.5 mm, as taught by Norton, to provide to provide substantial stops that prevent movement past each other.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liptak et al. US 2016/0184129 A1 in view of Quaka et al. US 2014/0326252 A1 further in view of Norton US 4,671,766 and Jansheski et al. US 2008/0138755 A1.
Regarding claim 15, Liptak in view of Quaka further in view of Norton discloses the claimed invention as discussed above.
Liptak in view of Quaka further in view of Norton is silent on a projected area of the upper moldable component and the lower moldable component on a horizontal plane being greater than a projected area of the upper bracket and the lower bracket on the same plane.
However, Jansheski teaches a dental guard 10 (fig. 1A and [0002]) comprising an analogous moldable component 16 and bracket 12 (fig. 1A and [0021], base member 12 and over-molded thermoplastic material 16), wherein a projected area of the moldable component 16 on a horizontal plane is greater than a projected area of the bracket 12 on the same plane (fig. 1A and [0021], thermoplastic anterior flange 16 is overmolded at the top of the base member 12; thus, in a horizontal plane parallel to the occlusal surface of the dental guard 10, a projected area of the moldable material 16 is greater than a projected area of the base 12 in the area where material 16 is overmolded over the base 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper moldable component and the lower moldable component of Liptak in view of Quaka further in view of Norton such that a projected area of the upper moldable component and the lower moldable component on a horizontal plane is greater than a projected area of the upper bracket and the lower bracket on the same plane, as taught by Jansheski, to prevent any irritating edges along the perimeters of the trays.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liptak et al. US 2016/0184129 A1 in view of Quaka et al. US 2014/0326252 A1 further in view of Jansheski et al. US 2008/0138755 A1.
Regarding claim 21, Liptak in view of Quaka discloses the claimed invention as discussed above.
Liptak in view of Quaka is silent on a projected area of the upper moldable component and the lower moldable component on a horizontal plane being greater than a projected area of the upper bracket and the lower bracket on the same plane.
However, Jansheski teaches a dental guard 10 (fig. 1A and [0002]) comprising an analogous moldable component 16 and bracket 12 (fig. 1A and [0021], base member 12 and over-molded thermoplastic material 16), wherein a projected area of the moldable component 16 on a horizontal plane is greater than a projected area of the bracket 12 on the same plane (fig. 1A and [0021], thermoplastic anterior flange 16 is overmolded at the top of the base member 12; thus, in a horizontal plane parallel to the occlusal surface of the dental guard 10, a projected area of the moldable material 16 is greater than a projected area of the base 12 in the area where material 16 is overmolded over the base 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the upper moldable component and the lower moldable component of Liptak in view of Quaka such that a projected area of the upper moldable component and the lower moldable component on a horizontal plane is greater than a projected area of the upper bracket and the lower bracket on the same plane, as taught by Jansheski, to prevent any irritating edges along the perimeters of the trays.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE J LEE whose telephone number is (571)270-7303. The examiner can normally be reached 9 AM - 5 PM.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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