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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 2/18/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-4, 7-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Habeb et al. (U.S. Pub. No. 20180368936) hereinafter Habeb.
Regarding claim 1, Habeb teaches:
A measurement element for an oral care device (abstract), the measurement element comprising:
at least one elongate ridge element configured to fit within an interproximal region within an oral cavity by aligning a longitudinal axis of the ridge element with the interproximal region ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes chamfered edges and elongate ridge elements on the sides of the device that overlap with the dental tissue including teeth and gingival tissue. The dashed line in the annotated figure below points to the portion of the body 12 that corresponds to the “elongate ridge element”, which in this exemplary figure 1 corresponds to placement on a region of teeth. The device provides for work to be performed on a desired position that could include treatment of imaging (sensing), and this includes a portion of the gingiva and the teeth as disclosed in [0070]-[0071]. The description of a possible “work site” in [0070] and [0071] provide for the device to be placed with “one form of clamp may attach to two teeth” and “The work site is the portion of the oral cavity that requires diagnosis or treatment. In some instances, this may be the entire upper or lower arch, whereas in other instances this may only be a portion of the oral cavity, such as one or more teeth, a portion of the gingiva, or a combination of the two.”. While not depicted in the cited figures of the Habeb reference, when the device is attached across two teeth, with a worksite corresponding to “one or more teeth, a portion of the gingiva, or a combination of the two” the longitudinal axis of the elongate ridge element depicted by the two-way line in the annotated figure below, would be aligned with and be positioned across the interproximal region between the two adjacent teeth. Therefore, the device includes the outer edge portion (of body 12, indicated by the dashed line below) as an elongate ridge element configured to fit within an interproximal region within an oral cavity when attached to two teeth with portion of both teeth and gingiva; see also [0050]-[0061])
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a first sensing region located in a first chamfered longitudinal end portion of the at least one elongate ridge element, configured to face a gingival tissue within the interproximal region when the longitudinal axis of the ridge element is aligned with the interproximal region, and further configured to acquire data from the gingival tissue ([0044]-[0045], “is generally rectangular in shape with chamfered edges for minimising patient discomfort”; figure 1; [0050]-[0061], camera 31 is located in the chamfered end portion of the elongate ridge element as depicted in figures 1-2. This camera forms a sensing region that when the worksite includes the teeth and gingiva that acquires imaging data from gingival tissue as claimed; As described in [0070]-[0071], but not depicted in the cited figures, a worksite may correspond to “one or more teeth, a portion of the gingiva, or a combination of the two” in which instance the housing 12 that includes the elongate ridge element indicated by the dashed line in the annotated figure 1 above, would be positioned with the longitudinal axis aligned across an interproximal region of gingiva tissue between two adjacent teeth. With camera 31 positioned in the reference’s figures as within the chamfered portion of the elongate ridge element ).
Regarding claim 2, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
further comprising:
a first protrusion extending from the first end portion of the at least one elongate ridge element ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes a protrusion that extends downward from the first end portion of the elongate ridge element and wraps around the teeth structure as a clamp; [0050]-[0061]; [0071]);
wherein the first sensing region is located in a wall of the first protrusion ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes a protrusion that extends downward from the first end portion of the elongate ridge element and wraps around the teeth structure as a clamp and the camera 31 is located within the wall of the first protrusion on a side of the dental structure; [0050]-[0061]; [0071]).
Regarding claim 3, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
further comprising:
a second sensing region located in a second chamfered longitudinal end portion of at least one elongate ridge element for acquiring data from gingival tissue within the oral cavity ([0044]-[0045]; figure 1; [0050]-[0061], the disclosed imaging feature provides for optional plurality of cameras wherein the second camera would be a second sensing region that is located in a second end portion of at least one elongate ridge element for acquiring data from gingival tissue. A second camera is disposed on the opposite protrusion wall on an opposite side of a tooth forms a second chamfered longitudinal end portion).
Regarding claim 4, Habeb teaches all of the limitations of claim 3. Habeb further teaches:
further comprising:
a second protrusion, extending from a second end portion of the at least one elongate ridge element ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes a protrusion that extends downward from the first end portion of the elongate ridge element and wraps around the teeth structure as a clamp. The second protrusion forms the opposite side to the first protrusion; [0050]-[0061]; [0071])
wherein the second sensing region is located in a wall of the second protrusion ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes a protrusion that extends downward from the first end portion of the elongate ridge element and wraps around the teeth structure as a clamp and the camera 31 is located within the wall of the first protrusion on a side of the dental structure. The wall of the second protrusion is the opposite side of the tooth to the first protrusion; [0050]-[0061]; [0071])
Regarding claim 7, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
wherein the at least one elongate ridge element comprises a central recessed portion, such that a height of the at least one elongate ridge element at its center is smaller than a height of the at least one elongate ridge element at its ends ([0044]-[0045], [0065], as shown in figure 1, 2f, and 6 the central portion of the elongate ridge element is smaller than the height at the edges, which allows a tooth to be positioned in the central recessed portion, with the ends height being utilized to secure the device to the tooth and dental arch; see also [0050]-[0061]; [0071])
Regarding claim 8, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
further comprising:
a cleaning element located within the at least one elongate ridge element ([0044], suction is considered to be a cleaning element; [0048]; [0050]-[0051], suction conduit forms a cleaning element)
Regarding claim 9, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
further comprising a surface from which the at least one elongate ridge element extends ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes a main surface from which the elongate ridge elements extend; see also [0050]-[0061]; [0071])
Regarding claim 10, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
wherein the first sensing region is configured to receive radiation to be delivered to an optical sensor ([0044]-[0045], figure 1; [0050]-[0061], camera receives optical radiation as an optical sensor; [0071])
Regarding claim 11, Habeb teaches:
A measurement element for an oral care device (abstract) comprising:
at least two elongate ridge elements configured to fit within adjacent teeth within an oral cavity ([0044]-[0045]; figure 1 and figure 2, the elongate ridge elements form the elongate chamfered edges on an interior and exterior side of a tooth and as disclosed in [0070]-[0071], can be configured to operate across adjacent teeth within an oral cavity. This forms a region between each elongate ridge element in which the teeth of interest are disposed and fit within adjacent teeth); and
a first sensing region having at least one sensor located on a central portion that projects out between the at least two elongate ridge elements, configured to acquire data from gingival tissue within the oral cavity ([0044]-[0045]; figure 1; [0050]-[0061], camera 31 is located in the central end portion between the elongate ridge elements as depicted in figures 1-2. This camera forms a sensing region that when the worksite includes the teeth and gingiva that acquires imaging data from gingival tissue as claimed, and projects out toward the teeth and between the ridge elements; see [0052], “a camera 31 (again which may be disposed on an inner wall of the body 12 facing the work site”, which forms a projection in the interior central portion that projects out from the inner wall and toward the worksite (teeth and gingival tissue); see also [0071]).
Regarding claim 13, Habeb teaches all of the limitations of claim 1. Habeb further teaches:
A mouthpiece (abstract) comprising:
an arch-shaped body for fitting at least partially over a dental arch of a subject ([0044]-[0045], figure 1, apparatus 12 forms an arch shaped body that fits over the teeth and gum region, which forms at least a partial fit over a dental arch of a subject; see also figures 2; [0050]-[0061]; [0071]);; and
the measurement element according to claim 1, the measurement element located on a surface of the dental care device configured to fit within an interproximal region of the dental arch of the subject ([0044]-[0045], as shown in figure 1, the body 12 of the apparatus 10 includes chamfered edges and elongate ridge elements on the sides of the device that overlap with the dental tissue including teeth and gingival tissue. The device provides for work to be performed on a desired position that could include treatment of imaging (sensing), and this includes a portion of the gingiva and the teeth as disclosed in [0070]-[0071]. Therefore, the device includes the outer edge portion as an elongate ridge element configured to fit within an interproximal region within an oral cavity when attached to two teeth with portion of both teeth and gingiva; see also [0050]-[0061]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Habeb as applied to claim 1 above, and further in view of Borotto et al. (U.S. Pub. No. 20170265978) hereinafter Borotto.
Regarding claim 5, primary reference Habeb teaches all of the limitations of claim 1. Primary reference Habeb further fails to teach:
wherein the first sensing region comprises a plurality of sensor windows; and wherein the plurality of sensor windows are at least one of.
a) positioned at different heights from a base of the at least one elongate ridge element; and
b) directed at different angles from one another with respect to a base of the at least one elongate ridge element
However, the analogous art of Borotto of a device and method for monitoring teeth contact points and forces (abstract) teaches:
wherein the first sensing region comprises a plurality of sensor windows; and wherein the plurality of sensor windows are at least one of.
a) positioned at different heights from a base of the at least one elongate ridge element; and
b) directed at different angles from one another with respect to a base of the at least one elongate ridge element ([0070]-[0073], show a plurality of sensors conductive pads as depicted in figures 4 and 6 which form a plurality of sensor windows. As shown in figure 6, these arrays of sensor pads are angled at different angles relative to one another across the dental arch).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dental care engagement and measurement device of Habeb to incorporate the plurality of sensor pads (windows) positioned at different relative angles as taught by Borotto because such a setting provides a sensing structure that allows for precise quantitative measurement of the force/load applied on the sensor upon dental occlusion/clenching (Borotto, [0072]). This provides with a more accurate measurement of oral cavity pressure conditions leading to better analysis of health and improved clinical diagnostics.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Habeb as applied to claim 1 above, and further in view of Choo-Smith et al. (U.S. Pub. No. 20050283058) hereinafter Choo-Smith.
Regarding claim 6, primary reference Habeb teaches all of the limitations of claim 1. Primary reference Habeb further fails to teach:
wherein the at least one elongate ridge element comprises a substantially triangular prism-shaped element
However, the analogous art of Choo-Smith of an optical coherence tomography sensing system for dental tissue analysis (abstract) teaches:
wherein the at least one elongate ridge element comprises a substantially triangular prism-shaped element ([0056], “the tip having a triangular shaped tip with a triangular cross-section to allow the tip to be wedged into tight spaces such as the gingival embrasures between teeth”; In the combination with Habeb, the transmission light and camera system would incorporate the triangular prism (triangular cross-section) tip of the probe head as taught by Choo-Smith as the shape, which therefore would form a substantially triangular prism-shaped element of the elongate ridge element in the combined invention with Habeb).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dental care engagement and measurement device of Habeb to incorporate the triangular prism shaped element of the sensor as taught by Choo-Smith because it enables the sensing tip to be wedged into tight spaces such as the gingival embrasures between teeth (Choo-Smith, [0056]). This provides for enhanced imaging/measurements, leading to improved clinical outcomes.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Habeb as applied to claim 1 above, and further in view of Miller et al. (U.S. Pub. No. 20140272764) hereinafter Miller.
Regarding claim 12, primary reference Habeb teaches all of the limitations of claim 1. Primary reference Habeb further teaches:
An oral care device (abstract) comprising:
the measurement element according to claim 1 (see rejection of claim 1 above).
Primary reference Habeb further fails to teach:
a handle portion
However, the analogous art of Miller of a camera based dental sensor system for visualization of the oral cavity (abstract) teaches:
a handle portion ([0050], figure 1, handle including handle axis 107 element forms a handle portion for an intraoral camera sensor system; [0056];); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dental care engagement and measurement device of Habeb to incorporate the handle as taught by Miller because the use of a handle attachment allows precise positioning of the sensor by a user within hard-to-reach places of the oral cavity. This leads to improved image data collection, which leads to better diagnostics and clinical outcomes (see Miller, [0050]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798