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
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) 1-3, 5-11, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nozaki et al. (US 20180035896 A1) in view of Muller et al. (US 6485300 B1).
Regarding claims 1 and 14 and 16, Nozaki et al. disclose an interdental gap detection system for an oral inspection device, the gap detection system comprising, and method for detecting an interdental gap in an oral region of interest, including steps of: a light emission module configured to emit light to irradiate an oral region of interest/ irradiating an oral region of interest with light (The light passed through the optical waveguide 6a for emitting light changes its direction at a mirror 6b in the toothbrush head 41 and passes through an optical waveguide 6c for emitting light, and then a tooth 10 is irradiated with the light as excitation light from the light condensation unit 7 for emitting light, [0089]); an optical filter arranged to preferentially filter, from light reflected from or emitted by the oral region of interest, fluorescence emitted from oral structures in the oral region of interest/ detecting light reflected from or emitted by the oral region of interest, said light having passed through an optical filter arranged to preferentially filter fluorescence emitted from oral structures in the oral region of interest (“The optical filter 23 for receiving light is a filter for cutting wavelength components except fluorescence of interest. It is preferable to set the optical filter 23 for receiving light to cut a wavelength region excluding a range of 620 nm to 690 nm which is the wavelength region of fluorescence emitted by a fluorescent substance included in dental plaque. Since the reflected light of light from the light sources, directly reflected by the tooth, strongly appears particularly in a short-wavelength side, it is preferable to allow the optical filter 23 for receiving light to have sharp attenuation properties to cut the reflected light. Fluorescence spectra from dental plaque have two strong peaks at around 630 to 640 nm and around 670 to 680 nm, and an S/N ratio can be therefore improved by using, as the optical filter 23 for receiving light, a band-pass filter having transmittance properties similar to the shapes of the fluorescence spectra”, [0071]); and a sensor module configured to detect the filtered light and output corresponding sensor data/ outputting sensor data corresponding to the detected light (personal computer was used for measurement control and data processing, [0109], wavelength of 405 nm is output as an in-phase detection output 105, [0125], “In the fluorescence measuring device 500, excitation light from a first light source 2 or a second light source 3 is incident on a mirror M through a color mixture unit 4, an optical filter 5 for emitting light, and an optical waveguide 6 for emitting light. The mirror M includes a dichroic mirror, a half mirror, or the like, and has the properties of reflecting light in the wavelength region of excitation light and transmitting light in the wavelength region of fluorescence. Accordingly, excitation light from the first light source 2 or the second light source 3 is reflected by the mirror M, and passes through the shared optical waveguide 6A, and a tooth 10 including a portion 11 to which dental plaque adheres is irradiated with the excitation light as first irradiation light 8 or second irradiation light 9 from a light condensation unit 7 for emitting light. Examined light 20 (fluorescence) from the tooth 10 is incident on the light condensation unit for emitting light, re-passes through the shared optical waveguide 6A, and arrives at the mirror M. However, since the mirror M transmits light in the wavelength region of fluorescence, the examined light 20 passes through the mirror M and arrives at a light detector 24 through an optical waveguide 22 for receiving light and an optical filter 23 for receiving light. In the fluorescence measuring device 500, the optical filter 5 for emitting light and the optical filter 23 for receiving light can be omitted. For example, one brush of a toothbrush can be used as the shared optical waveguide 6A in the fluorescence measuring device 500. In such a case, dental plaque can be stably detected because emitted light is not shielded by a brush other than brushes for receiving light. Accordingly, detection can be reliably performed particularly in a gap portion such as an interdental space or a periodontal pocket, to which dental plaque easily adheres, and practical usefulness is therefore provided, [0155]-[0157]); wherein the system further comprises a processor module configured to process the sensor data output by the sensor module, to identify the presence of an interdental gap in the oral region of interest/ processing said sensor data to identify the presence of an interdental gap in the oral region of interest (Accordingly, detection can be reliably performed particularly in a gap portion such as an interdental space or a periodontal pocket, to which dental plaque easily adheres, and practical usefulness is therefore provided, [0157]).
It is noted that while the detection of the interdental gap is only specified in one embodiment, it would have been obvious at the time of filing to one of ordinary skill in the art to use different filters as needed to detect specific different structures such as interdental spaces that are commonly imaged in dental applications. To the extent Nozaki et al. do not make explicitly clear how the identifying the presence of an interdental gap in the oral region of interest is done, another reference is provided.
Muller et al. teach a processor module configured to process the sensor data output by the sensor module, to identify the presence of an interdental gap in the oral region of interest/ processing said sensor data to identify the presence of an interdental gap in the oral region of interest (“There are also likely to be "false" minima of fluorescence emission where the illumination means is not directing the exciting radiation at tooth surfaces, and/or the detection means is/are not positioned to detect fluorescence emission from tooth surfaces. For example this may occur when the illumination means and/or detection means are aimed at or adjacent to gaps in the teeth, other parts of the mouth than teeth, or dental fillings etc. The device of the invention may be constructed to ignore such false minima, i.e. any fluorescence intensity peak below a specified certain value, e.g. responding only to intensity peaks within certain specified limits corresponding to the limits within which fluorescence emission from tooth surfaces is actually expected to occur.”, col. 4, lines 40-52, “The device according to this embodiment may have at least two detection means, at least two of which are spaced apart at the above-mentioned distances. Suitably the detection of fluorescence emission of the two spaced apart distances may be performed simultaneously. Any difference between the intensity of fluorescence emission detected at the two spaced apart regions can be associated with the presence of biological deposits. Of course the situation may occur that in use one of the spaced apart regions, e.g. one of two or more detection means is not in a position to detect fluorescence emission from a tooth surface, e.g. if it is adjacent a gap in the teeth, mouth tissue, fillings etc. In such a case the difference in intensity of the fluorescence emission detected at the spaced apart regions is likely to exceed the maximum difference that would be expected to occur between a test tooth surface with a biological deposit on it, and a clean surface, and the device may be constructed to ignore all such differences which are greater than a specified certain value, for example responding only to differences between certain specified limits.”, col. 5, lines 38-57).
Nozaki et al. and Muller et al. are in the same art of dental devices (Nozaki et al., abstract, [0032]; Muller et al., abstract, FIG. 10, col. 16, lines 5-10). The combination of Muller et al. with Nozaki et al. will enable processing said sensor data to identify the presence of an interdental gap in the oral region of interest. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the gap detection of Muller et al. with the invention of Nozaki et al. as this was known at the time of filing, the combination would have predictable results, as Muller et al. indicate “It is desirable to detect such deposits on the teeth before removing them, for example by toothbrushing, as detection indicates the areas at which dental cleaning effort should be concentrated. Such deposits can be difficult to detect in situ in vivo on the teeth. It is especially important to detect dental plaque” (col. 1, lines 19-24) thereby as having the most complete understanding of user dental anatomy will allow for the most adaptive dental care, this combination will yield the most complete mapping of dental anatomy and plaque to enable the most effective plaque removal.
Regarding claims 2 and 15, Nozaki et al. and Muller et al. disclose the interdental gap detection system and method according to claims 1 and 14. Nozaki et al. and Muller et al. further indicate the light emission module is configured to emit light having a wavelength in a range of from 405 to 450 nm/ the light irradiating the oral region of interest has a wavelength in a range of from 405 to 450 nm (Nozaki et al., wavelength of 405 nm is output as an in-phase detection output 105, [0125]; Muller et al., emits a fluorescence emission in the wavelength region above 420 nm, typically as shown in FIG. 1, peaking in intensity above ca. 450 nm, col. 2, line 65 – col. 3, line 5).
Regarding claim 3, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 1. Nozaki et al. and Muller et al. further indicate the light emission module comprises an LED light source, or a laser light source (Nozaki et al., Light-emitting diodes and semiconductor lasers which are small-sized and inexpensive can be used as the first light source 2 and the second light source 3, [0064]; Muller et al., exciting radiation from such an LED may be directed to the tooth surface by a light guide, col. 8, lines 19-20).
Regarding claim 5, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 1. Nozaki et al. and Muller et al. further indicate the filter is configured to preferentially absorb blue light, the blue light has a wavelength in a range of from about 400 nm to about 495 nm (Nozaki et al., When the clean tooth and the tooth to which the dental plaque adheres are irradiated with blue light having a wavelength of 465 nm, the broad peak P0 of intrinsic fluorescence from the teeth is observed similarly in the case of the irradiation with purple light having a wavelength of 405 nm; however, since PPIX is weakly excited, peaks P1 and P2 originating from the dental plaque are not observed, [0059]; Muller et al., light emitting diode (LED) capable of emitting radiation in the blue region of the visible spectrum, preferably including radiation between 430 and 500 nm, col. 8, lines 10-15).
Regarding claim 6, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 1. Nozaki et al. and Muller et al. further indicate the processor module is configured to identify the presence of an interdental gap in the oral region of interest, based on (i) identification of a difference in an amount of filtered light reflected or emitted from a first region as compared with the amount of filtered light reflected or emitted from a second region, or (ii) based on a perceived or measured colour difference between a first region and a second region (Nozaki et al., control unit calculates the amount of the fluorescent substance using a difference or ratio between the first intensity of the reflected light and the second intensity of the reflected light, [0026], [0053], [0061]; Muller et al., “On tooth 102 the probe 108 detects fluorescent emission from a clean part of the tooth surface, and the probe 109 detects fluorescent emission from an area 102A of the tooth surface where there are biological deposits. The intensities of the fluorescent emission detected by the two probes 108, 109 differ, that detected by probe 109 being less than that detected by probe 108. This difference is however within limits set by the internal electronics and software of the device, and is used to indicate to the user the presence of the biological deposits on the tooth 102. On tooth 103 the probe 108 detects fluorescence emission from a region 103A of the tooth 103 where there is biological deposit, and probe 109 is located at a gap between the teeth. On tooth 104 the probe 108 detects fluorescent emission from a clean region of tooth 104, and probe 109 is adjacent an amalgam filling 110, from which there is no fluorescent emission. With both teeth 103 and 104 the difference between the fluorescent emission detected by the probes 108 and 109 is greater than the limits preset in the electronics and software of the device and is ignored by the device, so that no false reading is given”, col. 15, line 40 – col. 16, line 6).
Regarding claim 7, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 1. Nozaki et al. and Muller et al. further indicate the processor module is configured to output a signal on identification of the presence of an interdental gap in the oral region of interest (Nozaki et al., The notification unit 31 notifies a user of the toothbrush of the determined amount of the fluorescent substance. Buzzer sound, or electronic sound generated by using a piezoelectric element may be used in such notification. In the case of the electronic sound, feedback can be given to the user by changing the pitch or loudness of the sound, or the pitch of the intermittent sound according to the amount of the fluorescent substance. A voice messages generated by voice synthesis, music, or the like may also be used, [0074]; In this way, i.e. the method described above with respect to FIG. 9, fluorescence intensity against time/distance across the set of teeth were obtained showing a high signal when contacting the teeth and fluorescence gaps (low signals) in the interdental regions between the teeth, these gaps being ignored, col. 17, lines 20-30) [While Nozaki et al. do not specifically disclose the notification happens when the gap is detected, as different structures create different fluorescence signals, a gap can be set as a notification prompting entity].
Regarding claim 8, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 1. Nozaki et al. and Muller et al. further indicate oral inspection or treatment device incorporating the gap detection system according to claim 1 (Nozaki et al., toothbrush head of the fluorescence measuring device 400, [0032]; Muller et al., The toothbrush heads 89 ad 810 shown in FIG. 8 include two probes suitable for use in the process described with respect to FIG. 10, col. 16, lines 5-10).
Regarding claim 9, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 8. Nozaki et al. and Muller et al. further indicate the oral inspection or treatment device is a dental cleaning appliance, further comprising a body and a cleaning tool head (Nozaki et al., The toothbrush-type fluorescence measuring device 400 is an example of optical measuring devices using fluorescence as examined light, and includes a toothbrush head 41, a stem unit 42, and a grip unit 43, [0078]; Muller et al., The toothbrush 81 comprises a handle 82, a head 83 which carries tufts of cleaning bristles 84, and a connecting neck region 85 between them, col. 13, lines 55-60).
Regarding claim 10, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 9. Nozaki et al. and Muller et al. further indicate one or both of the light emission module and the sensor module of the interdental gap detection system are provided on the cleaning tool head (Nozaki et al., Light from the first light source 2 and the second light source 3 is guided to the toothbrush head 41 through a color mixture unit 4 and an optical filter 5 for emitting light, disposed in the grip unit 43, as well as an optical waveguide 6a for emitting light with a long tapered shape, disposed in the stem unit 42. The direction of the guided light is changed using means such as a mirror or the like in the toothbrush head 41, and a tooth surface is irradiated with the light as excitation light from a light irradiation unit 50 on the toothbrush head 41. Fluorescence generated on a tooth is guided to a light detector 24 through brushes 40 that are arranged in a light detection unit 51 of the toothbrush head 41 and are made of a material that transmits fluorescence, [0078]; Muller et al., In a preferred embodiment of this invention the apparatus comprises a toothbrush, for example having means to direct exciting radiation at the test tooth surface and the means to detect fluorescence emission from the test tooth surface incorporated into the toothbrush head, e.g. having one or more optical fibres as described above incorporated and terminating at an optical probe in the toothbrush head, so that the optical probe can be conveniently close to the test tooth surfaces of a user, e.g. within 1 cm or less, being approximately the usual length of toothbrush bristles, col. 9, lines 54-63).
Regarding claim 11, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 9. Muller et al. further indicate the processor module is provided as part of a controller module located within the body of the dental cleaning appliance (Conveniently the illumination means, detection means and the various electronic signal/data processing means etc., and a suitable electrical power supply, e.g. a battery or electrical mains connection, may be provided in the handle of the toothbrush. If such a toothbrush has an electrically driven cleaning brush then in such a construction all of the electrical components, e.g. the drive motor etc., can be incorporated into the toothbrush handle, col. 10, lines 5-15).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over (US 20180035896 A1) as applied to claim 1 above, further in view of Yoshitani et al. (IDS: LumiO: A Plaque-aware Toothbrush).
Regarding claim 4, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 1. Nozaki et al. and Muller et al. do not disclose the optical filter is selected from a yellow filter, or a yellow-green filter.
Yoshitani et al. teach the optical filter is selected from a yellow filter, or a yellow-green filter (QLF uses light in a wavelength around 405 nm (which is blue-violet) to excite yellow-green fluorescence in a range above 520 nm. Thus, an intraoral camera with a yellow high-pass filter
(l > 520 nm) captures sound enamel in green, p607).
Nozaki et al. and Muller et al. and Yoshitani et al. are in the same art of dental devices (Nozaki et al., abstract, [0032]; Muller et al., abstract, FIG. 10, col. 16, lines 5-10; Yoshitani et al., abstract). The combination of Yoshitani et al. with Nozaki et al. and Muller et al.will enable using a yellow-green filter. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the yellow-green filter of Yoshitani et al. with the invention of Nozaki et al. and Muller et al. as this was known at the time of filing, the combination would have predictable results, as Yoshitani et al. indicate “In QLF, an enamel, plaque, and gingival area brights green, red and brown, respectively. This spectral characteristic is beneficial in a vision-based classification method because it is straightforward to distinguish teeth and plaque” (p608) thus making detection more accurate, and therefore plaque removal more effective.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over (US 20180035896 A1) as applied to claim 1 above, further in view of Farkash et al. (US 20220189611 A1).
Regarding claim 12, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 7. Nozaki et al. and Muller et al. do not disclose the processor module is provided as part of a controller module located within a remote device, wherein the remote device and the oral inspection or treatment device are configured for communication with one another to allow for exchange of signals and/or data.
Farkash et al. teach the processor module is provided as part of a controller module located within a remote device, wherein the remote device and the oral inspection or treatment device are configured for communication with one another to allow for exchange of signals and/or data (“The intraoral scanner 101 may also include one or more processors, including linked processors or remote processors, for both controlling the wand 103 operation, including coordinating the scanning and in reviewing and processing the scanning and generation of a 3D model including surface and internal features. As shown in FIG. 1B the one or more processors 113 may include or may be coupled with a memory 115 for storing scanned data (surface data, internal feature data, etc.). Communications circuitry 117, including wireless or wired communications circuitry may also be included for communicating with components of the system (including the wand) or external components, including external processors. For example, the system may be configured to send and receive scans or 3D models. One or more additional outputs 119 may also be included for outputting or presenting information, including display screens, printers, etc. As mentioned, inputs 121 (buttons, touchscreens, etc.) may be included and the apparatus may allow or request user input for controlling scanning and other operations”, [0054]).
Nozaki et al. and Muller et al. and Farkash et al. are in the same art of dental devices (Nozaki et al., abstract, [0032]; Muller et al., abstract, FIG. 10, col. 16, lines 5-10; Farkash et al., [0007]). The combination of Farkash et al. with Nozaki et al. and Muller et al. will enable having a processor module is provided as part of a controller module located within a remote device, wherein the remote device and the oral inspection or treatment device are configured for communication with one another to allow for exchange of signals and/or data. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the configuration of Farkash et al. with the invention of Nozaki et al. and Muller et al. as this was known at the time of filing, the combination would have predictable results, and as remote processing will allow more detailed analysis to be conducted without needing as much physical space in the dental device itself, thus providing a space saving benefit while still providing disease scanning benefits, as Farkash et al. indicate “It would be beneficial to provide tools that may aid in the inspection, visualization, and analysis regarding the health of a patient's oral health, including soft tissue around the teeth. It would also be beneficial to provide one or more tools that may aid in monitoring the health of the patient's periodontium and teeth over time for early detection or prevention of periodontal disease, cancer, and other oral diseases” ([0006]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nozaki et al. (US 20180035896 A1) and Muller et al. (US 6485300 B1) as applied to claim 9 above, further in view of Gerhardt et al. (US 20230346115 A1).
Regarding claim 13, Nozaki et al. and Muller et al. disclose the interdental gap detection system according to claim 9. Nozaki et al. and Muller et al. do not explicitly disclose on identification of the presence of an interdental gap in the oral region of interest, the dental cleaning appliance is configured to apply a treatment to the identified interdental gap in the oral region of interest.
Gerhardt et al. teach on identification of the presence of an interdental gap in the oral region of interest, the dental cleaning appliance is configured to apply a treatment to the identified interdental gap in the oral region of interest (“Moreover, the support unit is embodied, comprises and/or consists of a handle for a toothbrush/brush head and/or a flossing unit. The handle may comprise a power train and a power supply for tooth brushing and tooth flossing, e.g. an electric motor, a battery and/or a fluid reservoir and actuator”, [0080], “For example, with the additional data generated by the added sensor functionality an occlusal surface of teeth can be detected, and a flossing procedure can be improved based on the detected occlusal surface by adapting the amount of flossing fluid emitted. This can enable a variety of business models and business schemes, which may generate additional revenue for producers of personal care systems”, [0093]).
As Nozaki et al. and Muller et al. disclose detecting a gap and Gerhardt et al. teach on identification of the presence of a dental feature in the oral region of interest, the dental cleaning appliance is configured to apply a treatment to the identified feature in the oral region of interest, together the references disclose on identification of the presence of an interdental gap in the oral region of interest, the dental cleaning appliance is configured to apply a treatment to the identified interdental gap in the oral region of interest.
Nozaki et al. and Muller et al. and Gerhardt et al. are in the same art of dental devices (Nozaki et al., abstract, [0032]; Muller et al., abstract, FIG. 10, col. 16, lines 5-10; Gerhardt et al., [0033]). The combination of Gerhardt et al. with Nozaki et al. and Muller et al. will enable adapting the treatment to a gap. It would have been obvious at the time of filing to one of ordinary skill in the art to combine the configuration of Gerhardt et al. with the invention of Nozaki et al. and Muller et al. as this was known at the time of filing, the combination would have predictable results, and as Gerhardt et al. indicate “For example, with the additional data generated by the added sensor functionality an occlusal surface of teeth can be detected, and a flossing procedure can be improved based on the detected occlusal surface by adapting the amount of flossing fluid emitted. This can enable a variety of business models and business schemes, which may generate additional revenue for producers of personal care systems”, ([0093]) demonstrating an improvement to the dental treatment effectiveness as well as a commercial benefit to combining inventions.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE M ENTEZARI HAUSMANN whose telephone number is (571)270-5084. The examiner can normally be reached 10-7 M-F.
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/MICHELLE M ENTEZARI HAUSMANN/Primary Examiner, Art Unit 2671
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