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 § 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 with an inner surface (left side of Fig. 3); a second arm with inner surface (right side of Fig. 3); a central axis that is equidistant from the first arm and second arm (see annotated Fig. 3 below) and a device arch width of about 41 mm to about 53 mm where the device arch width being measured between the highest point of the inner surface of the first arm and the highest point of the inner surface of the second arm, wherein the first and second highest points are measured on a plane orthogonal to the central axis at a depth of about 15 mm to about 22 mm from the lens outer surface/inner surface of mouthpiece along the central axis (these measurements 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/distance from the lenses near central axis; see annotated Fig. 3 below and compare to Fig. 20 of present invention); 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]).
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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 is less than 10C during 5 minutes of use as measured according to the light device temperature method (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).
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, 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 is water resistant and has an International Electrotechnical Commission (IEC) standard IEC 60529 rating in a range of IPX3-IPX9.
With respect to claim 6, the battery would be capable of supplying at least seven 5-minute uses in powering an LED, as powering an LED uses minimal charge. 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; 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Newman et al. (US 2017/0197089).
Wang discloses the device as previously described above, but fails to show wherein the device has a total weight of 500 grams or less.
Newman similarly teaches a tooth-whitening device wherein consideration is taken to minimize the weight of the device, less than 100 grams in regards to Newman’s device, and therefore less than 500 grams as claimed ([54]-[58], along with Table 1, go into detail of how to keep the weight low particularly with regards to recognizing Energy/Weight ratios of the batteries, and more efficient LED arrangement and power distribution among those). 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 device to specifically keep the weight lower than 500g (such as the 100g of Newman) as taught by Newman in order to maximize comfort to the user and easily allow hands-free use ([0054]).
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.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive.
Applicant has not argued why Wang does not show the measurements, nor addressed the previous rejection thereof.
Applicant argues that Wang does not show a light range of greater than 150 mW/cm2, but also acknowledges that Wang shows up to 200 mW/cm2, which is greater than 150 mW/cm2.
Applicant argues Wang does not show the strategic placement of individual LEDs to specifically target interproximal spaces, however the strategic placement, if it were to be included in the claim, would be considered product-by-process wherein the end result is a mouthpiece with LEDs that are near an interproximal space, which is shown by Wang both in the recited paragraphs for widespread distribution of the LEDs and Fig. 4 for instance which shows dense arrangements of the LEDs such that at least some of the LEDs would be near interproximal spaces. It is unclear how this is speculative, since the structure of Wang results in at least some LEDs near interproximal spaces as claimed.
Applicant’s arguments with respect to the official notice have either been addressed with a provided reference or the following arguments. With respect to claim 6, the claim is not specific as to what the seven uses of the battery are directed to, whether by the claimed device (and if this is for all previously recited ranges of power, number of LEDs, etc.) or a different device/use. It is suggested to rather claim the battery capacity itself rather than the broad present recitation. With respect to claim 10, Applicant is arguing the office action has not identified art teaching the specific combination of timer features, however the claim does not include a specific combination of timer features, but rather alternative timer features. With respect to claim 13, no structure is included in the claim to support this careful engineering or achievement of rating, nor does the claim introduce structure that differentiates from the prior art and leads the implementation to be non-obvious. Simply making an intraoral device as water resistant as possible is well known in the art and it is suggested to include structure that would differentiate the water resistant configuration of the present invention against that of the prior art.
Applicant argues with respect to the very low peroxide concentrations, citing .1% H2O2 vs 25% H2O2, however this alleged critical concentration of .1% that leads to an unexpected result is not the present limitation of the claim (claim 17 states less than 35% weight, which includes the two values in the comparison, and claim 18 recites less than 7% weight), which are both shown by the prior art as addressed above. It is again noted that Wang teaches up to 200 mW/cm2.
Applicant argues that the present application demonstrates a critical range for the first time period (specifically 25 minutes), however the present claims very broadly recite greater than 0 seconds to 120 minutes. If 25 minutes is what is believed to be critical and lead to unexpected results, it is suggested to claim that specific value.
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 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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