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 .
Applicants' arguments, filed 03/09/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103—New by Amendment
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 11-13, 18-20, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groves Jr. et al., (US 2018/0325622) in view of Sanzari et al., (US 2011/0189626) and further in view of Li et al., (Nature Communications, 2013) and Osterwalder (US 2005/0202363).
Groves Jr. et al. discloses a system and method for preventative dental hard tissue treatment with a laser (TI). “The system can include a laser source for generating at least one pulse of a laser beam; at least one optic in optical communication with the laser source, the at least one optic adapted to define laser beam width and focus the laser beam at or near a surface of the dental hard tissue; and a controller adapted to control pulse energy based on the defined beam width . . .” (p. 1, para. [0004]).
In one embodiment, “the invention relates to a system for treating a treatment region of a dental hard tissue to resist acid dissolution, where the treatment region has a stained pellicle adhered thereto. The system can include: a laser source for generating at least one pulse of a laser beam directed toward a location in the treatment region; and controller adapted to control the laser source such that a surface temperature of the location is raised during the laser pulse to at least a temperature necessary for removal of at least a portion of the stained pellicle” (p. 3, para. [0020]).
“As described above, according to some embodiments preventative 8 to 12 µm laser treatment elevates the local surface temperature of the enamel, such that various biofilms are removed, including: tartar, calculus, and pellicle” (p. 14, para. [0123]).
In regard to heating, the prior art provides a general condition for use of the laser such that “a surface temperature of the location is raised during the laser pulse to at least a temperature necessary for removal of at least a portion of the stained pellicle (p. 3, para. [0020]). Further, “A temperature necessary for removal of a portion of the pellicle, plaque or biofilm is typically over 100 degrees Celsius. For example, dental autoclaves intended to remove or sterilize oral fluids typically operate between 121-132 degrees Celsius” (p. 14, para. 0121]). This amount would have been sufficient to prevent substantial change to carbonate or acid resistance of the tooth.
This general condition reads on the claimed range of about 100 to 400 ºC insofar as the specification discloses that the pellicle is removed within this temperature range, i.e., “the enamel is raised to a temperature within a first range between about 100ºC and about 400ºC. In this first range, the salivary pellicle is substantially removed, but the enamel does not experience any substantial improvements to its mechanical properties (e.g., removal of carbonate, increased crystallinity, increased modulus [i.e., stiffness], increased resistance to acid or acid or increased hardness)” (p. 19, lines 28-32). It must be remembered, "[W]here 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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)).
Groves Jr. also teaches, “The raised surface temperature can be in a range from 300 to 1800 degrees Celsius” (p. 2, para. [0009]), which overlaps with the claimed range of about 100ºC and about 400ºC. It is well settled, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Moreover, “After laser treatment the enamel can be said to have an exposed surface, which is largely free from biofilms. According to some embodiments, the exposed enamel surface is treated with a whitening agent after the biofilms, to some extent, have been removed. The whitening agent would typically contain from 1 to 60% hydrogen peroxide (clm. 19-20), with or without an optically activated agent added. The optical activation wavelength for various whitening activation agents can be provided from a source with a wide spectral range, for example between 200 nm and 20 µm. Hydrogen peroxide breaks down into an oxygen radical which removes stain on the enamel. With the biofilm and pellicle layer generally removed with laser treatment, the whitening agent can be applied more directly to the enamel surface removing more stains” (p. 14, para. [0123]).
Since the whitening treatment is taught to occur after removal of the pellicle, with no time frame requirement, it would have been reasonable to apply the whitening treatment within an hour after pellicle removal, as per claim 12.
Groves Jr. et al. does not teach wherein the whitening agent is applied via a tray.
Sanzari teaches, “A teeth whitening system includes a head unit adapted to be worn on a user’s head, a light housing supported by the head unit proximate to the user’s mouth, the light housing including a light source, and a mouth piece including a tray portion adapted to surround the user’s teeth” (Abstract). The light source is taught to provide a wavelength in a range of “from about 350 nanometers (nm) to about 700 nm” (p. 4, para. [0060]). Here, the prior art wavelength range lies inside the claimed range of about 250nm to 750nm, which is prima facie obvious.
“One of the common ways to apply a bleaching paste is the use of a dental tray which holds the bleach in contact with the teeth, but prevents the bleach from flowing away from the teeth” (p. 1, para. [0008]; see also p. 5, Claim 11).
“As mentioned previously, the teeth whitening system 100 can include a tooth whitening agent, such as a whitening gel” (p. 4, para. [0058]). Since the tray “can” include a tooth whitening agent, i.e. it is not inherent to the tray, it would have been obvious or expected for the artisan to insert the gel using a dispenser, as a means for inserting the gel onto the tray, as per claim 13.
“The mouth piece 19 and the light housing 5 can be coupled together to transmit light from the light source (e.g., LEDs 104) through the mouth piece 19 and to the whitening gel and/or the user’s teeth” (p. 3, para. [0047]), wherein “the gel utilizes hydrogen peroxide as an oxidizing agent” (p. 4, para. [0059]).
“The increase in temperature of the whitening gel may speed up the oxidation process, resulting in a complete teeth whiting process that takes less time than prior systems, for example, in approximately twenty to forty minutes” (p. 2, para. [0031]; clms. 12, 18). Tooth whitening times are expected to vary from patient to patient depending on their level of tooth staining and whitening goals. Accordingly, it would have been obvious to optimize a time for whitening teeth, as per claim 18.
The device includes a battery for powering the LED lights, e.g., “a rechargeable battery such as a NiMH, NiCD, or LiON battery may be used. Alternatively, non-rechargeable batteries can be used” (p. 2, para. [0037]).
It would have been obvious to a person having ordinary skill in the art to use a tray for tooth whitening in the method of Groves Jr. et al. for the advantage of whitening efficacy, i.e., it holds the whitening agent in contact with the teeth, but prevents the whitening agent from flowing away from the teeth, as taught by Sanzari.
The combination of Groves Jr. et al. and Sanzari et al., which is taught above, differs from claim 11 insofar as it does not teach that the battery is a zinc air type battery.
Li et al. teaches, “Primary and rechargeable Zn-air batteries could be ideal energy storage devices with high energy and power density, high safety and economic viability” (Abstract).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use zinc air type batteries to power the device of Sanzari et al. for the advantage using a battery known for high energy and power density, high safety and economic viability, as taught by Li et al.
The combination of Groves Jr. et al. and Sanzari et al., which is taught above, differs from claim 11 insofar as it does not teach that the tray comprises a wireless network connection.
Osterwalder teaches, “An intra-oral dental irradiation device for use in dental procedures for whitening teeth, imaging teeth, and making impressions of tooth structures of a patient” (Abstract).
The device comprises a “micro-controller” for “recording/transmitting patient identification data and information regarding treatment parameters such as current, power, and temperature or the like. This information may be electronically communicated to a nearby computerized base station for live monitoring of the treatment procedure, as well as for storing case history” (p. 7, para. [0068]).
Communication to the computer may be wireless, i.e., “[a]gain, a wireless connection 138 can be used. Here, however, the wireless connection 138 will be between the detectors 106 or dental tray 140 and the computer monitor 132” (p. 8, para. [0077]).
In regard to claim 25, Osterwalder teaches, “Such a device should be flexible and require low voltage while still being capable of irradiating large areas of the dental arch for impression curing and/or whitening” (p. 2, para. [0015]). The flexibility of the device would have reasonably included the circuitry disposed within the tray. Osterwalter illustrates Figure 3 described as “a detailed perspective view of the flexible circuit board” (p. 4, para. [0044]), shown below:
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The artisan would have been motivated to provide flexible circuitry in order to fit the device that conforms to the contours of the teeth. Osterwalter further teaches, “As human mouths are infinitely variable in the arch shape of their teeth 20, the device too is infinitely variable by flexing to fit individual mouths” (p. 6, para. [0064]).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a wireless network connection to the device of Sanzari for the advantage of recording/transmitting patient identification data and information regarding treatment parameters such as current, power, and temperature or the like, as taught by Osterwalder. It would have also been obvious to provide flexible circuitry in order to match the variable flexibility of the device that conforms to the variable arch of the user’s mouths.
2) Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groves Jr. et al., (US 2018/0325622) in view of Sanzari et al., (US 2011/0189626) and further in view of Li et al., (Nature Communications, 2013) and Osterwalder (US 2005/0202363) as applied to claim 11 above, and further in view of Soukos et al., (US 2005/0064371).
The combination of Groves Jr. et al., Sanzari et al., Li et al, and Osterwalder differs from claims 21-24 insofar as it does not teach a prescribed dosage.
Soukos et al. teaches a method and device for improving oral health “by exposing the oral cavity of the subject to a device comprising a light source that emits a therapeutically effective amount of light” (Abstract).
Note: the notion of a biphasic dose response is philosophy of the “Arndt-Scholz rule of pharmacology”, which states “For every substance, small doses stimulate, moderate doses inhibit, and large doses kill” (see Specification at p. 12, para. [0043]). This speaks to the notion of providing a therapeutically effective amount of light. It is well settled, “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Doses of light taught by Soukos et al. includes a “wavelength of the light” in a “range of form about 350 nm to about 700 nm” (p. 6, para. [0077]), which is consistent with the wavelength taught by Sanzari et al. Further, “The intensity (energy density) of the light may range from about 1 mW/cm2 to about 1000 mW/cm2 or higher” (p. 6, para. [0078]), which overlaps with the claimed ranges of irradiance recited in claims 22-24.
Doses further include, “from about 0.1 Joules/cm2 to about 1000 Joules/cm2” (p. 7, para. [0087]), which overlaps with the claimed ranges of fluence recited in claims 22-24.
Doses further include, “duration of exposure of the light to the teeth and/or gums”, which “may range from about 5 seconds to about an hour” (p. 6, para. [0079]), which overlaps with the claimed ranges of time recited in claims 22-24.
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to provide a prescribed dosage, including suitable wavelengths of light, intensity, irradiance, fluence, and time of exposure, as claimed, for providing therapeutically effective amounts of light to the tooth structure, in the method of Groves Jr. et al. as taught by Soukos et al.
Technological Background
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Bruns et al., (US 5,810,587). Bruns et al. is pertinent for teaching, “Teeth whitening in dentistry is generally performed by applying a whitening chemical for a period of time. The invention described herein speeds teeth whitening by removing all organic and inorganic contaminants in the tooth enamel pellicle thereby aiding in the delivery of the tooth whitening agent directly to the tooth” (col. 1, lines 57-64).
Response to Arguments
Applicant argues that the claimed temperature range of about 100 to 400ºC is “critically different than the Groves range” insofar as it prevents carbonate content and acid resistance, while the temperature range of 300 to 1800ºC in Groves “reduces carbonate content and increases acid” (p2, 3rd paragraph). Applicant concludes that the claimed range is therefore critical under MPEP 2144.05(III).
The Examiner disagrees.
In regard to criticality of a range, MPEP 2144.05 (III) states, “applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.”
However, applicant’s argument does not presence evidence of unexpected results relative to the prior art range. "[I]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice" (In re De Blauwe, 736 F.2d 699,705 (Fed. Cir. 1984)).
“To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). (MPEP 716.02(d)(II)).
Applicant has not demonstrated criticality of the claimed range by comparing a sufficient number of tests both inside and outside the claimed range.
Terms like “unexpected” and “surprising” are not part of applicant’s disclosure, let alone associated with a temperature range of about 100 to 400ºC.
In regard to the claimed range of about 100 to 400ºC, Groves Jr. et al. teaches, “A temperature necessary for removal of a portion of the pellicle, plaque or biofilm is typically over 100 degrees Celsius. For example, dental autoclaves intended to remove or sterilize oral fluids typically operate between 121-132 degrees Celsius” (p. 14, para. 0121]). Accordingly, the artisan would have expected pellicle removal within the claimed range.
In regard to carbonate content and acid resistance, Groves Jr. provides a teaching that avoids substantial change to the mechanical properties of the tooth, i.e., “In some instances, the raised temperature is a least equal to a lower temperature threshold defined as a temperature that causes at least one of (i) a minimum increase in an acid dissolution resistance of the dental hard tissue and (ii) a minimum decrease in an amount of surface carbonate of the dental hard tissue” (p. 2, para. [0009]).
ii) Applicant argues that Li and Sanzari do not provide motivation to use Zinc air batteries for powering light sources in oral whitening trays and the rejection is based solely on hindsight reasoning.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination (MPEP 2144.II.). In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). >See also Dystar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick, 464 F.3d 1356, 1368, 80 USPQ2d 1641, 1651 (Fed. Cir. 2006) ("Indeed, we have repeatedly held that an implicit motivation to combine exists not only when a suggestion may be gleaned from the prior art as a whole, but when the 'improvement' is technology-independent and the combination of references results in a product or process that is more desirable, for example because it is stronger, cheaper, cleaner, faster, lighter, smaller, more durable, or more efficient. Because the desire to enhance commercial opportunities by improving a product or process is universal-and even common-sensical-we have held that there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.") (see MPEP 2144).
In this case, zinc air batteries were known for high energy and power density, high safety and economic viability, which are suitable reasons for using these types of batteries in a battery powered device.
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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
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