DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(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 1-19 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.
Claim 1 recites “a device arch width”, however no device arch has been established, with the only language directed to the shape being a first and second arm. It is unclear what this is referring to and it is suggested to include the structure of an arch in the claims. Claim 16 relies on claim 1.
Claim 6 recites “a single full charge independent of battery age”. It is unclear what this is intended to mean since all batteries have an age and will eventually degrade. No examples of an infinite battery have been provided in the specification, so it remains unclear how this would be accomplished or what was meant by this limitation.
Claim 11 recites the limitation "the light device temperature method" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 11 also recites “wherein a temperature increase of the outer surface of the lens as measured at the LED center is less than 10C”, however the lens is separate from the LED and therefore it is unclear how an outer surface of the lens can be measured at the center of an LED.
Claim 15 is unclear for similar reasons to claim 1 above. Additionally, it is unclear what is meant by “the first highest point” and the “second highest point”, since these positions in the present invention’s figures are not at the highest points. The highest points instead appear to be towards the center of the mouthpiece. It seems these are just arbitrary points toward the top of the mouthpiece and will be addressed as such.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-9, 11, 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US 2021/0038357).
Wang shows an oral care light device comprising a housing comprising a mouthpiece (Fig. 3-4 for instance), wherein the mouthpiece comprises a lens having an outer surface ([0048] such as 350 which may be placed at any point across 310; such as in Fig. 8); a first arm (left side of Fig. 3); a second arm (right side of Fig. 3); and a device arch width in a range of from about 41 mm to about 53 mm at a predetermined depth in a range of from about 15 mm to about 22 mm (while it is unclear exactly what these measurements are in relation to as detailed in the 112 rejection above, they fall within the average width/depth of human dental arch sizes and Wang discusses that the mouthpiece covers at least a portion of the arch which allows the mouthpiece to cover within this range); and a light source positioned in the housing (302 for instance), the light source being capable of emitting electromagnetic radiation through the lens ([0048]), the electromagnetic radiation comprising one or more wavelengths in a range from about 200 nm to about 1700 nm ([0036]) and an average light intensity of about 150 mW/cm2 or greater ([0036]). With respect to claims 2 and 3, these measurements are addressed similarly to the range disclosed in claim 1 above. With respect to claim 4, wherein the one or more wavelengths are in a range from about 380 nm to about 520 nm ([0036]). With respect to claim 5, further comprising a battery positioned in the housing, the battery being rechargeable or replaceable ([0045]). With respect to claims 7 and 8, wherein the mouthpiece is rigid and flexible ([0044] discusses hard/rigid portions and pliable/flexible portions). With respect to claim 9, wherein the light source comprises light-emitting diodes ("LEDs"), wherein at least one of the LEDs are positioned to emit light interproximally of two adjacent teeth during use ([0044], lenses 350 can be placed all across the mouthpiece as discussed above and therefore be positioned to emit light interproximally). With respect to claim 11, wherein the light source comprises an LED having an LED center (center of an LED), and wherein a temperature increase of the outer surface of the lens as measured at the LED center is less than 10C during 5 minutes of use as measured according to the light device temperature method (see 112 above, however LEDs emit very little heat and a lens next to an LED would therefore exhibit very little change in temperature falling within the 10C claimed). With respect to claim 14, wherein the device is self-contained (Fig. 2-3 for instance show the device self-contained, particularly when a battery is the power source).
Apparatus claim 15 is rejected similarly to the above and additionally a first arm having a first outer wall (outer wall on left side of Fig. 3), and a first inner surface of the first outer wall (near 320 in Fig. 3); a second arm having a second outer wall (opposite of first outer wall on right side of Fig. 3), and a second inner surface of the second outer wall (opposite first inner surface); a central axis extending from a proximal end of the device to a distal end of the device (extending down the center of the U shaped mouthpiece); and a device arch width defined between a first highest point on the first inner surface and a second highest point on the second inner surface, wherein the first highest point and the second highest point are on a plane, wherein the plane is orthogonal to the central axis of the mouthpiece and spaced a predetermined depth from the outer surface of the lens, wherein the predetermined depth is in a range from about 15 mm to about 22 mm, and the device arch width is in a range from about 41 mm to about 53 mm (these measurement limitations are addressed similarly as to with respect to claim 1 and selection of two points directly across from one another will result on being on a plane orthogonal to the central axis of the mouthpiece).
Kit claim 16 is rejected similarly to the above and additionally including a whitening composition ([0003], [0028] discusses inclusion of a whitening gel/agent).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6, 10, 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang.
Wang discloses the device as previously described above, but fails to show the battery is a rechargeable battery configured to supply at least seven 5-minute uses based on a single full charge independent of battery age; further comprising a timer, wherein the timer is configured to activate the light source after a delay period of time, is configured to deactivate the light source after an active period of time, is configured to prevent reactivation of the light source for a sleep period of time, or is configured to indicate that a period of disuse has occurred; wherein the device has a total weight of 500 grams or less; wherein the device is water resistant and has an International Electrotechnical Commission (IEC) standard IEC 60529 rating in a range of IPX3-IPX9.
The Office takes official notice that rechargeable batteries are very well known in the dental art for powering dental devices (see 112 rejection above regarding the battery age); utilizing a timer with optional delay/turn off built into the device is very well known for ensuring accurate application times in the whitening art; reducing weight of a device to be supported by the mouth and utilization of materials to allow for under 500g is well known in the dental art for increasing patient comfort; and providing water resistant properties and adhering to standards is very well known in the dental art to prevent buildup of bacteria, allow easy cleaning, and prevent shock. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to include these limitations as they are all well known in the art for providing the benefits above.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Rajaiah et al. (US 2022/0040061).
Wang discloses the device as previously described above, but fails to show wherein the whitening composition comprises a peroxide active having a concentration of less than 35% or 7%, by weight, of the whitening composition and further comprising an applicator.
Rajaiah similarly teaches a whitening composition for activation by a light source wherein the whitening composition comprises a peroxide active having a concentration of less than 35% or 7%, by weight, of the whitening composition ([0044]-[0046] discuss peroxide concentration of 35% in an aqueous phase that is .2857 or 1.2971% of the composition and therefore less than 7/35% by weight of the overall composition) and further comprising an applicator ([0274] discusses various applicators that may be used to apply the composition). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s kit to include the whitening composition and applicator as taught by Rajaiah in order to utilize known effective amounts of bleaching agent and safe application means in the dental art for achieving effective tooth whitening.
Wang also shows with respect to method claim 20 (aside from that already covered in previous claims) additionally applying a whitening composition including a bleaching agent to the teeth ([0003], [0028]); maintaining the whitening composition on the teeth for a first time period of greater than 0 seconds to 120 minutes without activating the light source (the amount of time between applying a whitening agent and then placing the mouthpiece onto the user and activating must be greater than 0 seconds since they are not done at the same time in [0028]); and after the first time period, directing electromagnetic radiation from the oral care light device of claim 1 toward the teeth for a second time period (“predetermined time”).
However Wang fails to show wherein the second time period is greater than 0 seconds to 120 minutes.
Rajaiah similarly teaches a whitening composition for activation by a light source wherein an application time of light is greater than 0 seconds to 120 minutes ([0278]; it is noted that Rajaiah also shows in this paragraph application for a first time period without light before exposure to light). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wang’s method by utilizing a light application time as taught by Rajaiah in order to utilize known treatment times for effectively whitening the teeth in the dental art, particularly with the whitening composition as also taught by Rajaiah.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW NELSON whose telephone number is (571)270-5898. The examiner can normally be reached on Monday-Friday 7:30am-5:00pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eric Rosen, at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW M NELSON/Primary Examiner, Art Unit 3772
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