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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, 7-8, 10, 14, 20, 35, 38 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Heacock et al (US 2015/0164618) in view of Nguyen et al (US 2006/0127837), Friedman et al (US 2019/0090980) and Levine (US 2011/0104633).
Regarding claim 1, Heacock discloses an oral treatment device comprising an intraoral mouthpiece (figure 3 and par 88 discloses the mouthpiece being used for treatment/therapy) comprising:
-a body (core 200) comprising a heat conducting material (par 60 discloses the core being made of aluminum which is a heat conductive material), body further comprising an upper surface and an opposite lower surface, said surfaces comprising a planar portion (see annotated figure 3, wherein the surfaces are considered planar as they are flat) between lingual edges (the middle portion extending to the phalanges on 214/216) and buccal or labial edges (the middle portion extending to the phalanges on 213/215), respectively, and configured to be placed against teeth surfaces (par 87 discloses the shape of the core being shaped for upper and lower teeth),
-a plurality of light sources (LED 203) attached to the body (see figure 3) and adapted to deliver light to teeth surfaces (par 87 discloses the lights being placed to allow irradiation of both teeth and gums),
wherein
-said edges comprise surfaces (phalanges 213-216), at least a part of which are planar and tilted with respect to the planar portions of the upper and lower surfaces (see figure 3),
-at least a part of the light sources (203) is positioned on at least one of the tilted buccal, labial or lingual edges of the heat conducting body (see figure 3, where LEDS 203 are located on the surfaces of phalanges 213-216), and
-the body and the light sources are embedded in an encasing comprising a transparent or translucent polymeric material (Coating 201, par 87 discloses the coating surrounding the entire bite plate and sealing against moisture, par 34 discloses the coating as transparent, and par 62 discloses the plate being covered or hermetically sealed with a transparent, liquid-tight elastic polymeric material to isolate electrical components)
Heacock fails to disclose the body being a heat conducting body that comprises a heat conducting polymer material, wherein the heat conducting polymer material has a thermal conductivity of 0.5 to 100 W/mK and the edge surface are tilted so as to form in cross-section of the heat conducting body an angle of 5 to 85 degrees with respect to the planar portions of the upper and lower surfaces.
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Annotated figure 3
Nguyen teaches a body of an intra oral treatment device (figure 4) being a heat conducting body (heat dissipating element 414) with a plurality of light sources attached (416, see figure 4, see par 41) for the purpose of distributing the heat from the light source to other regions of the device (par 41).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Heacock to have the body which is connected to the plurality of lights be a heat conducting body as taught by Nguyen for the purpose of distributing the heat from the light source to other regions of the device.
Friedman teaches a heat conducting body (compule that is thermally conductive, see par 36) comprising a heat conducting polymer material with a thermal conductivity of 0.5 to 100 W/mK (par 34-36 and 48 discloses a plurality of plastics with thermal conductivity in the range of 1 W/mK to 100 Wm/K) in a heated application (par 39) for the purpose of dissipating or regulating heat (par 36-37).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Heacock/Nguyen to have the heat conducting body comprise a heat conducting polymer material, wherein the heat conducting polymer material has a thermal conductivity of 0.5 to 100 W/mK as taught by Friedman for the purpose of dissipating or regulating heat, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Additionally, applicant discloses in the specification on page 9, lines 11-12 that the body is “metal or of a heat conducting polymer or combination thereof” which further supports the argument that which material is used is a design choice.
Levine teaches angling an edge surface (inner surface 30) which is tilted so as to form in cross-section of a body (see figure 4) an angle of 5 to 85 degrees with respect to the planar portions of an upper and/or lower surface (see annotated figure 4 and par 46 discloses the angle between the vertical axis and the angled surface is between 5-15 degrees, which would be equivalent to 85-75 degree relative to the horizontal axis and therefore falls within the claimed range, 90-5=85 and 90-15=75) for the purpose of positioning the edge surface against the user’s gum to create a seal around the treatment area (par 46).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, modify Heacock to have each of the edge surfaces tilted so as to form in cross-section of the body an angle of 5 to 85 degrees with respect to the planar portions of the upper and lower surfaces as taught by Levine for the purpose of positioning the edge surface against the user’s gum to create a desired contact around a treatment area.
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Regarding claim 2, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1, but fail to explicitly disclose the angle is from 10-55 degrees with respect to the planar portions of the upper and lower surfaces.
Levine discloses an inward tilt of the edges surface (30) which emits the light to position the mouthpiece against the users gums to create a seal (par 46) and for providing treatment via electrically activated light emitters to the surface of the user’s teeth (par 49), as such the angle of the edges surface can be adjusted based on the patient’s anatomy to provide a fit that creates the seal and enables light treatment to the teeth surface. As the angle can vary based on the desired fit and outcome of treatment it is considered a result effective variable. Therefore, one of ordinary skill in the art would have a reasonable expectation of success in modifying the angle of Heacock/Levine to have the surface of the edges within 10-55 degrees with respect to the planar portion of the upper and lower surfaces, as it involves only adjusting the position of the surface which is disclosed as needing positioning at an angle, and is thus a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 3, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1. Levine further teaches the edges form a slope towards the planar portions of the upper and lower surfaces (see figure 4, where the surface is sloped towards the horizontal), for the reasons set forth above.
Regarding claim 5, Heacock further discloses the polymeric material comprises a transparent or translucent thermoplastic or thermosetting material (par 62 discloses the clear cover/seal being silicone or polyurethane, which are transparent thermoplastic and thermosetting materials).
Regarding claim 7, Heacock further discloses the body (200) and the light sources (203) are at least partly encapsulated by the encasing and wherein the encasing has the shape of a dental arch having the shape of a dental arch (see figure 3 and par 87 which discloses the shape is capable of fitting the upper and lower teeth).
Regarding claim 8, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1. Heacock discloses the planar portion between lingual edges and buccal or labial edges of all embodiments should have an average thickness of less than 10, 7, 5, 4 or 3 mm (par 59), but fails to explicitly disclose the body is encapsulated by an encasing with a thickness in the planar portion extending to 0.1 mm or greater.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of Heacock/Levine from less than 10 to more than 0.1 mm since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 10, Heacock further discloses the body (200) embedded in the encasing (201) is capable of enduring temperature of up to 100 degree C during operation (in view of the disclosed body material aluminum, par 60 which is capable of enduring temperatures of up to 100 C in view of thermal stability see NPL Czerwinski figure 1 which shows an operative strength that occurs between 0 and 200 degrees C).
Regarding claim 14, Heacock further discloses the body (200) comprises a generally U-shaped arc so as to be able to follow a dental arc (par 37 discloses U shaped arcs for the various embodiments).
Regarding claim 20, Heacock further discloses the body (200) having an hour glass shaped cross-sectional profile (see figure 3) which is capable of covering the horizontal and two vertical surfaces of the teeth at one or both lines of teeth respectively (par 87 discloses the core providing a cup/trench for both the lower and upper teeth to fit including the vertical and horizontal sides of a tooth).
Regarding claim 35, Heacock/Nguyen/Friedman/Levine disclose the oral treatment device according to claim 1. Heacock further discloses a kit (which is any combination of objects under BRI) which includes a control electronic circuit (on/off switch 217 and wires 207) connected to the body (200, see figure 3).
In regard to claim 38, Heacock further discloses further including an intraoral agent selected from the group of antioxidant, photosensitizers, pigments, and potentiating agents and combination thereof (par 49 discloses teeth whitening with a photosensitizer, such as hydrogen peroxide agent).
Regarding claim 43, Heacock/Nguyen/Friedman/Levine discloses a mouthpiece as set forth above in the rejection of claim 1. Heacock discloses a method of treatment of intraoral tissue of a user (par 37 discloses the application of light to intraoral tissue), providing and placing the mouthpiece in the user’s mouth such that the upper and lower surfaces engage at least the chewing surface of the user’s teeth (par 87 discloses the shape of the core being shaped for upper and lower teeth); supplying the light sources with electric power for generating light (par 37 discloses the power being sent to the LED for a desired treatment); and directing the light toward the user teeth at an angle with respect to the plane of the chewing surface of the teeth to achieve photodynamic oral treatment of the teeth and oral tissue (see figure 3 show an angulation of light towards the outer surface of the device which would result in angulation towards the surfaces of the teeth and par 88 discloses the light being put against the teeth and gums in a manner which maximizes the exposure of energy for a period of time).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock et al in view of Nguyen et al, Friedman et al and Levine as applied to claim 1 above, and further in view of Mason (US 2012/0285574).
Regarding claim 4, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1, but fails to disclose the polymeric material forming the encasing comprises mixed therewith or as a coating on the encasing an antibacterial and/or light diffracting material.
Mason teaches a mouthpiece made of a polymer (par 64) which is coated with a light refracting and/or antibacterial coating (par 68 discloses the addition of a silver salt or enzyme onto the mouthpiece in a coating which acts as an anti-bacterial) for the purpose of helping to prevent or treat gum disease (par 68).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Heacock/Nguyen/Friedman/Levine the polymeric material forming the encasing comprises mixed therewith or as a coating on the encasing an antibacterial and/or light diffracting material as taught by Mason for the purpose of helping to prevent or treat gum disease.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock et al in view of Nguyen et al, Friedman et al and Levine as applied to claim 1 above, and further in view of Scott (US 2005/0142514).
Regarding claim 6, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1.
Heacock discloses the body (200) comprises the heat conducting material comprising a heat conducting metal material, wherein the metal material has a thermal conductivity of between 100 to 500 W/mK (where the disclosed heat conducting material is aluminum par 60 which has a thermal conductivity of 236 W/mK, see Engineering Toolbox NPL).
Additionally, Friedman teaches the polymer material has a thermal conductivity of 1 to 100 W/mK (par 36 and 48 discloses a compule made of a plastic with thermal conductivity in the range of 1 W/mK to 100 Wm/K), for the reasons set forth above.
However, Heacock/Nguyen/Friedman/Levine fail to disclose the body comprising both the heat conducting metal and the heat conducting polymer.
However, Scott discloses a heat conducting body comprising both a heat conducting metal (heat sink portion 150) and the heat conducting polymer (thermally conductive polymer-based heat sink portion 152) for the purpose of providing additionally heat sink capacities (par 39).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of a claimed invention, to modify Heacock/Nguyen/Friedman/Levine to include both heat conducting plastic and heat conducting metal materials in the heat conducting body as taught by Scott for the purpose of providing improved or additional heat sink capacities.
Claim 9 and 11-12 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock et al in view of Nguyen et al, Friedman et al and Levine as applied to claim 1 above, and further in view of Kothari et al (US 2018/0256916).
Regarding claim 9, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1, but fails to disclose the body comprises an extended portion and wherein the body comprising the extended portion forms a cooling tray or surface capable of conducting heat from the body inside the encasing to outside of the encasing.
Kothari teaches a body (main body portion 14) comprising an extended portion (disclosed in par 55 as one or more portions of the main body portion protruding rearwardly beyond the wings) which forms a cooling tray or surface (the disclosed extension in combination with the main body 14 creating a cooling tray) capable of conducting heat away from the light source (par 58 discloses including a cooling system such as cooling system 98/100 which is provided to extract heat away from the light source).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Heacock/Nguyen/Friedman/Levine to have the body comprise an extended portion which forms a cooling tray or surface capable of conducting heat away from the light source as taught by Kothari, where the light source of Heacock/Friedman/Levine is located within the body inside of the encasing and therefore conduction of heat is from the body inside the encasing to outside of the encasing as recited in the claim, for the purpose of providing a controlled therapy to the gums and teeth which minimizes the chance of burning or uncomfortableness.
Regarding claim 11, Heacock/Nguyen/Friedman/Levine /Kothari disclose the claimed invention as set forth above in claim 9. Kothari further teaches the cooling tray through its extended portion, is connected to a cooling unit (cooling system 100/98 are both connected to the body through the extended portion as seen in figures 2 and 6) for cooling of the light source (par 58) for the reasons set forth above.
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date to modify further Heacock/Nguyen/Friedman/Levine/Kothari to have the cooling tray through its extended portion connect to a cooling unit for cooling the light source as disclosed by Kothari, wherein the light source of Heacock/Nguyen/Friedman/Levine is located within the body and is interpreted as the part of the body inside the encasing and therefore the cooling unit cools the part of the body inside of the encasing as claimed, for the reasons set forth above.
Regarding claim 12, Heacock/Nguyen/Friedman/Levine /Kothari disclose the claimed invention as set forth above in claim 9. Kothari further teaches the cooling tray through its extended portion, is connected to an active cooling unit (cooling system 100/98 are both connected to the body through the extended portion as seen in figures 2 and 6, system 98 discloses a fan which is considered an active cooling component) for cooling of the light source (par 58) for the reasons set forth above.
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date to modify further Heacock/Nguyen/Friedman/Levine /Kothari to have the cooling tray through its extended portion connect to an active cooling unit for cooling the light source as disclosed by Kothari, wherein the light source of Heacock/Nguyen/Friedman/Levine is located within the body and is interpreted as the part of the body inside the encasing and therefore the cooling unit cools the part of the body inside of the encasing as claimed, for the reasons set forth above.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock et al in view of Nguyen et al, Friedman et al, Levine and Kothari et al as applied to claim 9 above, and further in view of Flyash (US 2015/0044628).
Regarding claim 13, Heacock/Nguyen/Friedman/Levine /Kothari disclose the claimed invention as set forth above in claim 9. Kothari further teaches the cooling tray (the disclosed extension in combination with the main body 14 creating a cooling tray) is connected to an active cooling unit for cooling the light source (system 98 discloses a fan which is considered an active cooling component, see figure 2 and par 59) and a temperature sensor for reading the temperatures of the oral cavity during treatment (par 65), wherein the light source of Heacock/Nguyen/Friedman/Levine /Kothari is located within the body and is interpreted as the part of the body inside the encasing and therefore the cooling unit cools the part of the body inside of the encasing as claimed, for the reasons set forth above.
Heacock/Nguyen/Friedman/Levine /Kothari fail to disclose said active cooling unit being connected to the temperature sensor to allow for adjustment of cooling of the body depending on the temperature of the mouthpiece.
However, Flyash teaches an active cooling system (flushing well 112, which is disclosed in par 68 as a system to cool the mouthpiece during treatment ) which is connected to a temperature sensor (572, via a processor 112 which receives feedback real time as disclosed in par 72) to allow adjustment of cooling of the body depending on the temperature of the mouthpiece (par 72 discloses the processor adjusting treatment based on treatment parameters including the flushing well 112 which provides cooling liquid) for the purpose of providing a real time treatment adjustment during a dental treatment (par 72).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Heacock/Nguyen/Friedman/Levine /Kothari to have said active cooling unit being connected to the temperature sensor to allow for adjustment of cooling of the body depending on the temperature of the mouthpiece as taught by Flyash for the purpose of providing a real time treatment adjustment during a dental treatment, therefore minimizing uncomfortableness or operational errors.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock in view of Nguyen et al, Friedman et al and Levine and Senn et al (US 2016/0008115).
In regard to claim 36, Heacock/Nguyen/Friedman/Levine disclose a kit comprising the oral treatment device as set forth above in the rejection of claim 1. Heacock further discloses a control unit (par 33 discloses the electronics including a control panel in an extraoral housing). Heacock/Friedman/Levine fail to disclose an LED head and a docking station.
Senn teaches a kit comprising an LED head (U-shaped hood 600, with LEDS 110) and a docking station (charging device 33) for the purpose of providing a suitable charge or power supply for batteries (par 60) and providing a suitable coverage of the teeth (par 68).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Heacock/Nguyen/Friedman/Levine to have the kit include an LED head and a docking station as taught by Senn for the purpose of providing power to the batteries of the oral treatment device and suitable treatment coverage of all teeth.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock in view Nguyen et al, Friedman et al, and Levine.
Regarding claim 42, Heacock discloses a method of delivering light within an intraoral mouthpiece intended for photodynamic treatment of teeth and intraoral tissue (par 37 discloses the application of light to the teeth and gums for a desired treatment), comprising:
-providing a body (core 200) comprising a heat conducting material (par 60 discloses the core being made of aluminum which is a heat conductive material), the body (200) further having an upper surface and an opposite lower surface, said surfaces comprising an essentially planar portion (see annotated figure 3, wherein the surfaces are considered planar as they are flat) between lingual edges (the middle portion extending to the phalanges on 214/216) and buccal or labial edges (the middle portion extending to the phalanges on 213/215), respectively, and configured to be placed against teeth surfaces (par 87 discloses the shape of the core being shaped for upper and lower teeth),
-attaching a plurality of light sources (LED 203) to the body (200, see figure 3), and
-adapting the plurality of light sources to deliver light to teeth surfaces and intraoral tissue (par 87 discloses the lights being placed to allow irradiation of both teeth and gums),
-providing on the edges comprise surface (phalanges 213-216), at least a part of which are planar and tilted (see figure 3),
-positioning at least a part of the light sources on at least one of said tilted buccal, labial, or lingual edges of the body (see figure 3, where LEDS 203 are located pm the surfaces pf phalanges 213-216), and
-supplying the light sources with electric power for delivering light towards the user’s teeth and intraoral tissue (par 37 discloses the power being sent to the LED for a desired treatment).
Heacock fails to disclose the body being a heat conducting body comprises a heat conducting polymer material, wherein the heat conducting polymer material has a thermal conductivity of 0.5 to 100 W/mK and forming in cross-section of the body an angle of 5 and 85 degrees with respect to the planar portions of the upper and lower surfaces, and dissipating heat from hotspots around the mouth via the heat conducting polymer material.
Nguyen teaches a body of an intra oral treatment device (figure 4) being a heat conducting body (heat dissipating element 414) with a plurality of light sources attached (416, see figure 4, see par 41) and dissipating heat from hotspots around the mouth via the heat conducting body (par 40-41 discloses the heat dissipating element 414 being distributed across the entire region of the device and mouth) for the purpose of distributing the heat from the light source to other regions of the device (par 41).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Heacock to have the body which is connected to the plurality of lights be a heat conducting body and dissipating heat from hotspots around the mouth via the heat conducting body as taught by Nguyen for the purpose of distributing the heat from the light source to other regions of the device.
Friedman teaches a heat conducting body (compule that is thermally conductive, see par 36) comprising a heat conducting polymer material with a thermal conductivity of 0.5 to 100 W/mK (par 34-36 and 48 discloses a plurality of plastics with thermal conductivity in the range of 1 W/mK to 100 Wm/K) in a heated application (par 39) for the purpose of dissipating or regulating heat (par 36-37).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Heacock/Nguyen to have the heat conducting body comprise a heat conducting polymer material, wherein the heat conducting polymer material has a thermal conductivity of 0.5 to 100 W/mK as taught by Friedman for the purpose of dissipating or regulating heat, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Levine teaches angling an edge surface (inner surface 30) which is tilted so as to form in cross-section of a body (see figure 4) an angle of 5 to 85 degrees with respect to the planar portions of an upper and/or lower surface (see figure 4 and par 46 discloses the angle between the vertical axis and the angled surface is between 5-15 degrees, which would be equivalent to 85-75 degree relative to the horizontal axis and therefore falls within the claimed range, ad 90-5=85 and 90-15=75) for the purpose of positioning the edge surface against the user’s gum to create a seal around the treatment area (par 46).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, modify Heacock to have each of the edge surfaces tilted so as to form in cross-section of the body an angle of 5 to 85 degrees with respect to the planar portions of the upper and lower surfaces as taught by Levine for the purpose of positioning the edge surface against the user’s gum to create a seal around a treatment area.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock in view of Levine and Kothari et al.
Regarding claim 44, Heacock discloses an oral treatment device comprising an intraoral mouthpiece (figure 3 and par 88 discloses the mouthpiece being used for treatment/therapy) comprising:
a body (core 200)comprising a heat conducting material(par 60 discloses the core being made of aluminum which is a heat conductive material), the body (200) further comprising an upper surface and an opposite lower surface, said surfaces comprising a planar portion between lingual edges and buccal or labial edges (see annotated figure 3, wherein the surfaces are considered planar as they are flat, the middle portion extending to the phalanges on 214/216 and the middle portion extending to the phalanges on 213/215), respectively, and configured to be placed against teeth surfaces (par 87 discloses the shape of the core being shaped for upper and lower teeth), and
a plurality of light sources (LED 203) attached to the body (see figure 3) and adapted to deliver light to teeth surfaces (par 87 discloses the lights being placed to allow irradiation of both teeth and gums), wherein
said edges comprise surfaces (phalanges 213-216), at least a part of which are planar and tilted with respect to the planar portions of the upper and lower surfaces (see figure 3)
- at least a part of the light sources (203) are positioned on at least one of the tilted buccal, labial or lingual edges (213-16) of the body (200, see figure 3), and
the body and the light sources are embedded in an encasing comprising a transparent or translucent polymeric material (Coating 201, par 87 discloses the coating surrounding the entire bite plate and sealing against moisture, par 34 discloses the coating as transparent, and par 62 discloses the coating can be made of a polymeric material),
Heacock fails to disclose the edge surface are tilted so as to form in cross-section of the body an angle of 5 to 85 degrees with respect to the planar portions of the upper and lower surfaces and wherein the body comprises an extended portion, and wherein the body comprising the extended portion forms a cooling tray or surface capable of conducting heat from the body inside the encasing to the outside of the encasing.
Levine teaches angling an edge surface (inner surface 30) which is tilted so as to form in cross-section of a body (see figure 4) an angle of 5 to 85 degrees with respect to the planar portions of an upper and/or lower surface (see figure 4 and par 46 discloses the angle between the vertical axis and the angled surface is between 5-15 degrees, which would be equivalent to 85-75 degree relative to the horizontal axis and therefore falls within the claimed range, 90-5=85 and 90-15=75) for the purpose of positioning the edge surface against the user’s gum to create a seal around the treatment area (par 46).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, modify Heacock to have each of the edge surfaces tilted so as to form in cross-section of the body an angle of 5 to 85 degrees with respect to the planar portions of the upper and lower surfaces as taught by Levine for the purpose of positioning the edge surface against the user’s gum to create a seal around a treatment area.
Kothari teaches a body (main body portion 14) comprising an extended portion (disclosed in par 55 as one or more portions of the main body portion protruding rearwardly beyond the wings) which forms a cooling tray or surface (the disclosed extension in combination with the main body 14 creating a cooling tray) capable of conducting heat away from the light source (par 58 discloses including a cooling system such as cooling system 98/100 which is provided to extract heat away from the light source).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Heacock/Friedman/Levine to have the body comprise an extended portion which forms a cooling tray or surface capable of conducting heat away from the light source as taught by Kothari, where the light source of Heacock/Levine is located within the body inside of the encasing and therefore conduction of heat is from the body inside the encasing to outside of the encasing as recited in the claim, for the purpose of providing a controlled therapy to the gums and teeth which minimizes the chance of burning or uncomfortableness.
Claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Heacock in view of Nguyen et al, Friedman and Levine as applied to claim 1 above, and further in view of Nikinmaa et al (US 2021/0244965).
Regarding claims 45-46, Heacock/Nguyen/Friedman/Levine discloses the claimed invention as set forth above in claim 1, but fails to disclose the polymeric material forming the encasing comprises, mixed therewith or as a coating on the encasing, an antibacterial and/or light diffracting material, and wherein the antibacterial and/or light diffracting material comprises TiO2 and/or SiO2 and the antibacterial and/or light diffracting material comprises TiO2.
Nikinmaa teaches a polymeric material a coating on the encasing, an antibacterial and/or light diffracting material, and wherein the antibacterial and/or light diffracting material comprises TiO2 (par 111 discloses the mouthpiece surface is at least partially coated with titanium dioxide) for the purpose of providing therapeutic bacteria killing function (par 111).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Heacock/Nguyen/Friedman/Levine to have polymeric material a coating on the encasing, an antibacterial and/or light diffracting material, and wherein the antibacterial and/or light diffracting material comprises TiO2 as taught by Nikinmaa for the purpose of providing therapeutic bacteria killing function.
Claims 45 and 47 is rejected under 35 U.S.C. 103 as being unpatentable over Heacock in view of Nguyen et al, Friedman and Levine as applied to claim 1 above, and further in view of Raby et al (WO 2020/065538).
Regarding claims 45 and 47, Heacock/Nguyen/Friedman/Levine disclose the claimed invention as set forth above in claim 1, but fails to disclose the polymeric material forming the encasing comprises, mixed therewith or as a coating on the encasing, an antibacterial and/or light diffracting material, and wherein the antibacterial and/or light diffracting material comprises TiO2 and/or SiO2 and the antibacterial and/or light diffracting material comprises SiO2.
However, Raby teaches a coating with antibacterial and/or light diffracting material comprising SiO2 (par 37 discloses a coating layer 22 of a dental article which is anti-microbial and optical properties and include a layer of inorganic materials, par 39 provides exemplary materials which includes silica) for the purpose of increasing durability or wear resistant (par 38)
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Heacock/Nguyen/Friedman/Levine to have the polymeric material forming the encasing comprises, mixed therewith or as a coating on the encasing, an antibacterial and/or light diffracting material, and wherein the antibacterial and/or light diffracting material comprises TiO2 and/or SiO2 and the antibacterial and/or light diffracting material comprises SiO2 as taught by Raby for the purpose of increasing durability or wear resistance of the body.
Response to Arguments
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 42, applicant amends the claims to include the body is “a heat conducting body” in claim 1 and 42 and adds a step of “dissipating heat from hotspots around the mouth via the heat conducting polymer material” in claim 42. Applicant argues that the secondary reference Heacock/Friedman fails to render obvious “an intraoral mouthpiece comprising a heat conducting body comprising a heat conducting polymer” because Friedman does not relate to an oral treatment device comprising an intraoral mouthpiece and both Friedman and Heacock fail to disclose any heat dissipating or regulation
Applicant’s arguments with respect to the dissipation or regulation of heat or the combination of Heacock and Friedman have been considered but are moot because they do not address the new ground of rejection, including reference Nguyen as set forth above.
Regarding claims 1, 42 and 44, applicant argues the teaching of Levine fails to disclose in cross section of the heat conducting body an angle of 5-85 degrees with respect to the planar portions of the upper and lower surfaces. Applicant states that Levine discloses the angle being 5-15 degrees beyond vertical creating a range of 95-105 degrees with respect to the planar portion of the bite surface 12. The examiner disagrees, as set forth above in annotated figure 4 a planar portion of the upper/lower surface (bite surface 12) extending inward would be considered 0 or 360 degrees, Levine discloses an inward angle relative to the vertical of 5-15 degrees which would result in the surface of the body being between 85 and 75 degrees from the upper/lower surface (bite surface).
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.
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/S.N.B./ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
6/10/2026
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