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 .
Response to Amendment
This action is in response to the amendments and remarks filed on 10/16/2025. The amendments filed on 10/16/2025 have been entered. Accordingly Claims 1-5 and 7-22 are pending. Claim 6 has been canceled. Claim 22 is new. The previous objection(s), prior art rejections of claims 1-5 and 7-21 and 35 U.S.C. 112(b) rejection of claim 14 have been withdrawn in light of Applicant’s amendments and remarks in the claim set filed 10/16/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 22 limitation “…wherein the mouth guard is configured to enable insertion of and coupling to a second transducer array, which is different in size than the first transducer array, after the first transducer array has been removed.”, with respect to the second transducer array being coupled after the first transducer array is removed is subject matter not conveyed in the specification. The specification teaches for example: “The mouth guard 302 is illustrated in FIG. 3 with the two transducer arrays 304 and 306 as examples, and generally can include any suitable number of arrays, e.g., three transducer arrays, four transducer arrays, etc. The transducer arrays 304 and 306 can be removably attached to the mouth guard 302. For example, the transducer arrays 304 and 306 can be inserted into pockets of the mouth guard 302, or attached to a mechanical holder (e.g., a stand or clamp) in the mouth guard 302 (as discussed in more detail below with respect to FIG. 5 ).” [0041], thus connection of the first and second transducer array being included or removed attachment with respect to the mouth guard not with respect to one another (i.e. the transducer arrays).
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 3 and 22 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 3 recites the limitation “the reception” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 limitation “…wherein the mouth guard is configured to enable insertion of and coupling to a second transducer array, which is different in size than the first transducer array, after the first transducer array has been removed.”, is unclear how the transducer arrays and the size differentiations are interconnected with the removal of the first transducer array. It is unclear the connections of the first and second transducer array with respect to the mouth guard. The metes and bounds of the claim as a whole is unclear.
Claim Rejections - 35 USC § 102
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 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 17-19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (U.S. 20200281701, September 10, 2020)(hereinafter, “Kim”).
Regarding Claim 17, Kim teaches: A patient-worn ultrasound scanner (Figs.2-4, three-dimensional intraoral scanner, [0022]) comprising:
a mouth guard configured for insertion into a patient mouth (Figs. 2-4, “…the three-dimensional intraoral scanner may have a mouth guard or mouth tray form (or shape) that sits between a patient's upper and lower teeth and extends along all of (or substantially all of) the patient's teeth.” [0021]);
a first transducer array removably attached to a first surface of the mouth guard and configured to transmit ultrasound at a first side of one or more teeth and receive reflections of the ultrasound from the first side of the one or more teeth (Figs. 2-4, “…the three-dimensional intraoral scanner may have a mouth guard or mouth tray form (or shape) that sits between a patient's upper and lower teeth and extends along all of (or substantially all of) the patient's teeth.” [0021]; “…the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135.” [0024]); and
a transceiver configured to transmit ultrasound data based on the reflections to a processor system (“…the three-dimensional intraoral scanner 100 may include a wireless transceiver to wirelessly receive and transmit data to a nearby computer system.” [0030]).
Regarding Claim 18, Kim teaches the claim limitations as noted above.
Kim further teaches: further comprising a second transducer array removably attached to a second surface of the mouth guard and configured to transmit additional ultrasound at a second side of the one or more teeth and receive additional reflections of the additional ultrasound from the second side of the one or more teeth, wherein the ultrasound data is based on the additional reflections (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021]; “…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]; “…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028]. See Figs. 2-4).
Regarding Claim 19, Kim teaches the claim limitations as noted above.
Kim further teaches: wherein the mouth guard includes a first pocket implemented to hold the first transducer array when the first transducer array is attached to the mouth guard, the first pocket exposing electrical connectors in the mouth guard configured to interface with the first transducer array and transfer data based on the reflections to the transceiver (“Similar to the three-dimensional intraoral scanner 100, the three-dimensional intraoral scanner 200 may include a battery and a wireless transceiver for wireless operation…a wired connection may be provided to power the three-dimensional intraoral scanner 200 and for data transfer between the three-dimensional intraoral scanner 200 and a nearby computer system.” [0037]).
Regarding Claim 22, Kim teaches the claim limitations as noted above.
Kim further teaches: wherein the mouth guard is configured to enable insertion of and coupling to a second transducer array, which is different in size than the first transducer array, after the first transducer array has been removed (“Referring to FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120…” [0024]; “…the sled 320 may be modified to have a first group of sensors 330/335 that face into the first trough 410 and a second group of sensors 330/335 that face into the second trough 420…only one or two sleds 320 may be included in the three-dimensional intraoral scanner 400 because one sled 320 can image the patient's upper and lower teeth and oral cavity.” [0052]. See Figs. 2-4 and 16-17.
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.
Claims 1, 7 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (U.S. 20200281701, September 10, 2020)(hereinafter, “Kim”) in view of Pesach et. al. (WO2020144692, July 16, 2020, equivalent U.S. 12491058 passages are used in the rejection below).
Regarding Claim 1, Kim teaches: An ultrasound system (Figs.2-4, three-dimensional intraoral scanner, [0022]) comprising:
an ultrasound scanner including a mouth guard configured to, when inserted into a patient mouth to at least partially cover one or more teeth, transmit ultrasound at a patient anatomy and receive reflections of the ultrasound from the patient anatomy (Figs. 2-4, “…the three-dimensional intraoral scanner may have a mouth guard or mouth tray form (or shape) that sits between a patient's upper and lower teeth and extends along all of (or substantially all of) the patient's teeth.” [0021]; “…the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135.” [0024]; “…the three-dimensional intraoral scanner 100 may include a wireless transceiver to wirelessly receive and transmit data to a nearby computer system.” [0030]); and
a processor system coupled to the ultrasound scanner and configured to generate, based on the reflections of the ultrasound, an assessment of patient health (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028]),
wherein the patient anatomy includes a gum tissue (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028])
With regards to limitation: and the assessment of the patient health includes an indication of a stiffness of the gum tissue, Kim further teaches: “…the computer vision system may utilize a machine learning algorithm to colorize the received ultrasonic images for consistency with the received optical images, to accurately orient the received optical information with the received ultrasonic information, to create a point cloud (e.g., a set of data points in a three-dimensional space), and/or to create triangulated three-dimensional mesh with color textures. FIG. 18 shows examples of a point cloud of a patient's mouth, a dense point cloud of the patient's mouth, a three-dimensional representation (or model) of the patient's mouth, and a three-dimensional representation of the patient's mouth with texturing and shading.” [0028].
Kim does not explicitly teach gum stiffness.
Pesach in the field of dental systems teaches: “…the probe contact is used to detect surface properties other than geometry relative to the IOS, for example, tissue stiffness.” (column 16, lines 11-14);“…a force sensor may be used to evaluate the stiffness of a structure…and/or the softness of a structure…softness may be evaluated by correlating deformation of the tissue with the force applied.” (column 23, lines 2-7); “…periodontal health will be evaluated based the position of probed objects, the size of the pocket and/or the stiffness and/or softness of teeth and/or other tissue.”
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment in Kim to include gum stiffness as taught in Pesach “…to detect surface properties…” (Pesach, column 16, lines 11-14) and make determinations regarding dental conditions.
Regarding Claim 7, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes the one or more teeth and the assessment of the patient health includes an indication of tooth enamel for the one or more teeth (“In the three-dimensional intraoral scanner 200, sensors 230/235 may be arranged at a base of a trough 210 to capture images of tooth enamel…a mouthpiece shape with the trough 210 that extends under the patient's teeth, thereby providing images (e.g., optical images) of the enamel of a patient's teeth to better assist with diagnosing cavities and the like.” [0035]).
Regarding Claim 20, Kim teaches: A method comprising: inserting a patient-worn ultrasound scanner into a patient mouth (Figs. 2-4, “…the three-dimensional intraoral scanner may have a mouth guard or mouth tray form (or shape) that sits between a patient's upper and lower teeth and extends along all of (or substantially all of) the patient's teeth.” [0021]; “…the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135.” [0024]);
transmitting, with the ultrasound scanner, ultrasound at a patient anatomy (“…the three-dimensional intraoral scanner 100 may include a wireless transceiver to wirelessly receive and transmit data to a nearby computer system.” [0030]);
receiving, with the ultrasound scanner, reflections of the ultrasound from the patient anatomy (“…the three-dimensional intraoral scanner 100 may include a wireless transceiver to wirelessly receive and transmit data to a nearby computer system.” [0030]); and
generating, based on the reflections of the ultrasound, an assessment of patient health (“…the computer vision system may utilize a machine learning algorithm to colorize the received ultrasonic images for consistency with the received optical images, to accurately orient the received optical information with the received ultrasonic information, to create a point cloud (e.g., a set of data points in a three-dimensional space), and/or to create triangulated three-dimensional mesh with color textures. FIG. 18 shows examples of a point cloud of a patient's mouth, a dense point cloud of the patient's mouth, a three-dimensional representation (or model) of the patient's mouth, and a three-dimensional representation of the patient's mouth with texturing and shading.” [0028];“In the three-dimensional intraoral scanner 200, sensors 230/235 may be arranged at a base of a trough 210 to capture images of tooth enamel…a mouthpiece shape with the trough 210 that extends under the patient's teeth, thereby providing images (e.g., optical images) of the enamel of a patient's teeth to better assist with diagnosing cavities and the like.” [0035]).
Kim does not explicitly teach gum stiffness.
Pesach in the field of dental systems teaches: “…the probe contact is used to detect surface properties other than geometry relative to the IOS, for example, tissue stiffness.” (column 16, lines 11-14);“…a force sensor may be used to evaluate the stiffness of a structure…and/or the softness of a structure…softness may be evaluated by correlating deformation of the tissue with the force applied.” (column 23, lines 2-7); “…periodontal health will be evaluated based the position of probed objects, the size of the pocket and/or the stiffness and/or softness of teeth and/or other tissue.”
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment in Kim to include gum stiffness as taught in Pesach “…to detect surface properties…” (Pesach, column 16, lines 11-14) and make determinations regarding dental conditions.
Regarding Claim 21, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: further comprising generating an ultrasound image based on the reflections of the ultrasound, wherein the generating the assessment of the patient health includes processing the ultrasound image with a machine-learned model (“…the computer vision system may utilize a machine learning algorithm to colorize the received ultrasonic images for consistency with the received optical images, to accurately orient the received optical information with the received ultrasonic information, to create a point cloud (e.g., a set of data points in a three-dimensional space), and/or to create triangulated three-dimensional mesh with color textures. FIG. 18 shows examples of a point cloud of a patient's mouth, a dense point cloud of the patient's mouth, a three-dimensional representation (or model) of the patient's mouth, and a three-dimensional representation of the patient's mouth with texturing and shading.” [0028]).
Claims 2-5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Pesach as applied to claim 1 above, and further in view of Elbaz et. al. (U.S. 20220202295, June 30, 2022)(hereinafter, “Elbaz”).
Regarding Claim 2, the combination of Kim and Pesach teach the claim limitations as noted above.
with regards to limitation: wherein the patient anatomy includes the one or more teeth and a gum tissue health, and the assessment of the patient health includes at least one recession amount of the gum tissue for the one or more teeth, Kim further teaches: “…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028].
Kim does not explicitly teach assessment of recession amount of the gum tissue.
Elbaz in the field of intraoral data scanning analysis teaches: “Other time-based comparative analyses that may be performed include a time-based comparison of gum recession…” [0059]; “a doctor may set a gum recession amount threshold, and any identified gum recession that has a value that meets or exceeds the gum recession amount threshold may be identified as a found issue.” [0066].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment in Kim to include recession amount of the gum tissue as taught in Elbaz to allow the practitioner to make “… a determination as to whether there are any dental conditions that need to be dealt with immediately and whether there are any other dental conditions that are not urgent but that should be dealt with eventually and/or that should be monitored.” (Elbaz, [0003]).
Regarding Claim 3, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the mouth guard includes an inner transducer array and an outer transducer array both configured for transmission of the ultrasound and the reception of the reflections of the ultrasound (“…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]. See Figs. 2-4),
with regards to limitation: wherein the at least one recession amount includes one or more inner recession amounts based on the transmission and the reception from the inner transducer array and one or more outer recession amounts based on the transmission and the reception from the outer transducer array, Kim further teaches, “…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028].
Kim does not explicitly teach assessment of recession amount of the gum tissue.
Elbaz in the field of intraoral data scanning analysis teaches: “Other time-based comparative analyses that may be performed include a time-based comparison of gum recession…” [0059]; “a doctor may set a gum recession amount threshold, and any identified gum recession that has a value that meets or exceeds the gum recession amount threshold may be identified as a found issue.” [0066].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment in Kim to include recession amount of the gum tissue as taught in Elbaz to allow the practitioner to make “… a determination as to whether there are any dental conditions that need to be dealt with immediately and whether there are any other dental conditions that are not urgent but that should be dealt with eventually and/or that should be monitored.” (Elbaz, [0003]).
Regarding Claim 4, the combination of Kim and Pesach teach the claim limitations as noted above.
with regards to limitation: wherein the processor system implements a machine-learned model to generate the at least one recession amount, Kim further teaches, “…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028].
Kim does not explicitly teach assessment of recession amount of the gum tissue.
Elbaz in the field of intraoral data scanning analysis teaches: “Other time-based comparative analyses that may be performed include a time-based comparison of gum recession…” [0059]; “a doctor may set a gum recession amount threshold, and any identified gum recession that has a value that meets or exceeds the gum recession amount threshold may be identified as a found issue.” [0066].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment in Kim to include recession amount of the gum tissue as taught in Elbaz to allow the practitioner to make “… a determination as to whether there are any dental conditions that need to be dealt with immediately and whether there are any other dental conditions that are not urgent but that should be dealt with eventually and/or that should be monitored.” (Elbaz, [0003]).
Regarding Claim 5, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes the one or more teeth (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028]).
With regards to limitations: and the assessment of patient health includes a first image and a second image, the first image including a first predicted appearance of the one or more teeth that results without an installation of orthodontia, the second image including a second predicted appearance of the one or more teeth that results with the installation of the orthodontia, Kim further teaches: “…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; “The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]. See Figs. 2-4.
Kim does not teach a predicted before and after teeth results of installation of orthodontia.
Elbaz in the field of intraoral data scanning analysis teaches: “FIG. 5B illustrates an orthodontic treatment simulator user interface showing pre-treatment and post-treatment models of a dental arch, in accordance with embodiments of the present disclosure. The orthodontic treatment simulator may be launched responsive to a doctor selecting an orthodontic treatment 420 icon or button, such as from the user interface for malocclusion analysis and/or the user interface for occlusal contact analysis.” [0134]; “The orthodontic treatment simulator may determine a movement path to move one or more teeth from an initial arrangement of teeth 504 as determined from 3D models of a patient's current dental arches to a target arrangement of teeth 506 for the patient's dental arches. The target arrangement of the teeth (e.g., a desired and intended end result of orthodontic treatment) can be received from a clinician in the form of a prescription, can be calculated from basic orthodontic principles, and/or can be extrapolated computationally from a clinical prescription. In embodiments, a target arrangement for the patient's teeth is automatically determined based on aesthetic principles and/or ideal occlusion principles.” [0135].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kim to predict before and after teeth results of installation of orthodontia as taught in Elbaz such that “…the final position and surface geometry of each tooth can be specified to form a complete model of the tooth arrangement at the desired end of treatment.” [0137] and “…a movement path can be defined for the motion of each tooth.” (Elbaz, [0138]).
Regarding Claim 13, the combination of Kim and Pesach teach the claim limitations as noted above.
With regards to limitations: wherein the patient anatomy includes the one or more teeth and bone that holds roots of the one or more teeth, the one or more teeth have an orthodontia installed, and the assessment of the patient health includes a recommended adjustment of the orthodontia, Kim further teaches: “…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021]; “…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]; “…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028]. See Figs. 2-4.
Kim does not teach the one or more teeth have an orthodontia installed, and the assessment of the patient health includes a recommended adjustment of the orthodontia.
Elbaz in the field of intraoral data scanning analysis teaches: “FIG. 5B illustrates an orthodontic treatment simulator user interface showing pre-treatment and post-treatment models of a dental arch, in accordance with embodiments of the present disclosure. The orthodontic treatment simulator may be launched responsive to a doctor selecting an orthodontic treatment 420 icon or button, such as from the user interface for malocclusion analysis and/or the user interface for occlusal contact analysis.” [0134]; “The orthodontic treatment simulator may determine a movement path to move one or more teeth from an initial arrangement of teeth 504 as determined from 3D models of a patient's current dental arches to a target arrangement of teeth 506 for the patient's dental arches. The target arrangement of the teeth (e.g., a desired and intended end result of orthodontic treatment) can be received from a clinician in the form of a prescription, can be calculated from basic orthodontic principles, and/or can be extrapolated computationally from a clinical prescription. In embodiments, a target arrangement for the patient's teeth is automatically determined based on aesthetic principles and/or ideal occlusion principles.” [0135].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kim such that the one or more teeth have an orthodontia installed, and the assessment of the patient health includes a recommended adjustment of the orthodontia as taught in Elbaz such that “…the final position and surface geometry of each tooth can be specified to form a complete model of the tooth arrangement at the desired end of treatment.” [0137] and “…a movement path can be defined for the motion of each tooth.” (Elbaz, [0138]).
Regarding Claim 14, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim does not teach wherein the processor system is implemented to determine an amount of movement of the roots relative to the bone or a distance between the roots and the bone, and the recommended adjustment is based on at least one of the amount of the movement and the distance.
Elbaz in the field of intraoral data scanning analysis teaches: “FIG. 5B illustrates an orthodontic treatment simulator user interface showing pre-treatment and post-treatment models of a dental arch, in accordance with embodiments of the present disclosure. The orthodontic treatment simulator may be launched responsive to a doctor selecting an orthodontic treatment 420 icon or button, such as from the user interface for malocclusion analysis and/or the user interface for occlusal contact analysis.” [0134]; “The orthodontic treatment simulator may determine a movement path to move one or more teeth from an initial arrangement of teeth 504 as determined from 3D models of a patient's current dental arches to a target arrangement of teeth 506 for the patient's dental arches. The target arrangement of the teeth (e.g., a desired and intended end result of orthodontic treatment) can be received from a clinician in the form of a prescription, can be calculated from basic orthodontic principles, and/or can be extrapolated computationally from a clinical prescription. In embodiments, a target arrangement for the patient's teeth is automatically determined based on aesthetic principles and/or ideal occlusion principles.” [0135]; “…the movement paths are configured to move the teeth in the quickest fashion with the least amount of round-tripping to bring the teeth from their initial positions to their desired target positions.” [0138];” A force system to produce movement of the one or more teeth along the movement path may be determined. A force system can include one or more forces and/or one or more torques. Different force systems can result in different types of tooth movement, such as tipping, translation, rotation, extrusion, intrusion, root movement, etc. Biomechanical principles, modeling techniques, force calculation/measurement techniques, and the like, including knowledge and approaches commonly used in orthodontia, may be used to determine the appropriate force system to be applied to the tooth to accomplish the tooth movement.” [0139].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kim such that the processor system is implemented to determine an amount of movement of the roots relative to the bone or a distance between the roots and the bone, and the recommended adjustment is based on at least one of the amount of the movement and the distance as taught in Elbaz such that “…the final position and surface geometry of each tooth can be specified to form a complete model of the tooth arrangement at the desired end of treatment.” [0137], “…a movement path can be defined for the motion of each tooth.” (Elbaz, [0138]) and the knowledge and approaches “…may be used to determine the appropriate force system to be applied to the tooth to accomplish the tooth movement.” (Elbaz, [0139]).
Claims 8, 11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Pesach as applied to claim 1 above, and further in view of Wieland et. al. (U.S. 20220392645, December 8, 2022)(hereinafter, “Wieland”).
Regarding Claim 8, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes the one or more teeth and bone that holds roots of the one or more teeth (“…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; “The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]. See Figs. 2-4),
Kim does not teach: and the assessment of the patient health includes a recommendation to extract at least one tooth of the one or more teeth.
Wieland in the field of oral treatment systems teaches: “The implementation parameters may, e.g., define preparation requirements defining how teeth of the current state model have to be prepared for implementing the measures of a treatment option. Preparation requirements for teeth of the current state model may, e.g., be determined by a subtraction of the configured measures, like veneers or crowns. The configured measures may, e.g., be subtracted from the current state model registered with the target state model used to configure the measures. The configured measures may, e.g., be subtracted from the target state model registered with the current state model and the resulting reduced target state model may be subtracted from the current state model.” [0046]; “…the implementation parameters may define how much healthy tooth tissue has to be removed in order to provide a sufficient support surface for the veneer. For example, the implementation parameters may define how much healthy tooth tissue has to be removed in order to provide a preparation of a tooth suitable to support a ground. In case of a tooth extraction and replacement of the respective tooth by an implant, the implementation parameters may define the extraction of the respective tooth.” [0068].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment of the patient health in Kim to include a recommendation to extract at least one tooth of the one or more teeth as taught in Wieland to determine “…how an existing tooth of the current state model has to be prepared in order to provide a tooth stump with a suitable support for the respective crown.…” (Wieland, [0045]).
Regarding Claim 11, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes the one or more teeth (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028])
Kim does not teach: and the assessment of the patient health includes a binary indicator that indicates if at least one tooth of the one or more teeth can support a crown procedure.
Wieland in the field of oral treatment systems teaches: “The implementation parameters may, e.g., define preparation requirements defining how teeth of the current state model have to be prepared for implementing the measures of a treatment option. Preparation requirements for teeth of the current state model may, e.g., be determined by a subtraction of the configured measures, like veneers or crowns. The configured measures may, e.g., be subtracted from the current state model registered with the target state model used to configure the measures. The configured measures may, e.g., be subtracted from the target state model registered with the current state model and the resulting reduced target state model may be subtracted from the current state model.” [0046]; “…the implementation parameters may define how much healthy tooth tissue has to be removed in order to provide a sufficient support surface for the veneer. For example, the implementation parameters may define how much healthy tooth tissue has to be removed in order to provide a preparation of a tooth suitable to support a ground. In case of a tooth extraction and replacement of the respective tooth by an implant, the implementation parameters may define the extraction of the respective tooth.” [0068].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment of the patient health in Kim to include an indicator that indicates if at least one tooth of the one or more teeth can support a crown procedure as taught in Wieland to determine “…how an existing tooth of the current state model has to be prepared in order to provide a tooth stump with a suitable support for the respective crown.…” (Wieland, [0045]).
Regarding Claim 16, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes bone that holds roots of the one or more teeth (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021]; “…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]; “…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028]. See Figs. 2-4),
Kim does not teach: and the assessment of the patient health includes a score indicative of a health status of the bone to support a tooth implant.
Wieland in the field of oral treatment systems teaches: “The implementation parameters may, e.g., define preparation requirements defining how teeth of the current state model have to be prepared for implementing the measures of a treatment option. Preparation requirements for teeth of the current state model may, e.g., be determined by a subtraction of the configured measures, like veneers or crowns. The configured measures may, e.g., be subtracted from the current state model registered with the target state model used to configure the measures. The configured measures may, e.g., be subtracted from the target state model registered with the current state model and the resulting reduced target state model may be subtracted from the current state model.” [0046]; “…the implementation parameters may define how much healthy tooth tissue has to be removed in order to provide a sufficient support surface for the veneer. For example, the implementation parameters may define how much healthy tooth tissue has to be removed in order to provide a preparation of a tooth suitable to support a ground. In case of a tooth extraction and replacement of the respective tooth by an implant, the implementation parameters may define the extraction of the respective tooth.” [0068].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment of the patient health in Kim to include a score indicative of a health status of the bone to support a tooth implant as taught in Wieland to “…define how much healthy tooth tissue has to be removed in order to provide a sufficient support surface for the veneer…” (Wieland, [0068].
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Pesach as applied to claim 1 above, and further in view of Inam et. al. (U.S. 20210343400, November 4, 2021)(hereinafter, “Inam”).
Regarding Claims 9 and 10, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes the one or more teeth and bone that holds roots of the one or more teeth (“…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; “The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]. See Figs. 2-4),
Kim does not teach: and the assessment of the patient health includes a score that indicates a health of the bone; wherein the score is based on an amount of movement of the roots relative to the bone or a distance between the roots and the bone.
“FIG. 1A illustrates an example system 100 upon which aspects of this disclosure may be implemented. The system 100 may include a computing platform (e.g., a personal computer) 105 executing software that implements an image processor 200 (e.g., implemented as a ML model) which is coupled to receive a radiographic image 120 containing an oral structure 125 that could comprise a natural tooth, an implant, a restoration, etc., that further relates to craniofacial structures such as bones. The image processor 200 provides output, such as image metadata (e.g., detected features that appear in the image, and their corresponding labels) to a measurement processor 300 which in turn provides calibrated output (a calibrated measurement) based on the image metadata and data from a library…” [0085]; “The specific masks that the ML model implements for the image processor may depend on the specific measurement calibration process that is applied to the image to determine the scale that is to be used (e.g., determine the pixel-to-millimeter ratio for the imager). It is to be noted that in some situations only bone levels need measurement in mm, whereas ratio-based calculations (including area calculations), could be performed in the pixel space.” [0086]; “The selected DL model may predict masks for many labels such as tooth number, general tooth area, bone, enamel, restorations such as crown, filling/inlay, onlay, bridge, implants etc. The DL model itself may be an amalgam of several detection architectures (implementing multiple DL models that are combined to provide meaningful results). The best model identified with the help of metrics such as Intersection over Union (IoU) and bone level (distance between Cemento Enamel Junction (CEJ) and bone point) against a test set is chosen for the particular label. Further, the model may also directly predict the CEJ, and alveolar bone crest (hereafter called bone) points per tooth number. The model provides two ways of getting CEJ and bone points, which can be used to improve the confidence of the measurements.” [0092].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the assessment in Kim to include a score that indicates a health of the bone as taught in Inam “… to make a quick (expedited) determination of the reasonableness of a proposed treatment plan…” (Inam, [0007]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Pesach as applied to claim 1 above, and further in view of Schafer (U.S. 20150283277, October 8, 2015)(hereinafter, “Schafer).
Regarding Claim 12, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim further teaches: wherein the patient anatomy includes the one or more teeth (“…because the three-dimensional intraoral scanner includes both optical and ultrasonic sensors, the resulting three-dimensional representation may overlay both the visible tooth and gum condition with the underlying root condition.” [0021];“…a computer vision system (or computer vision algorithm) may use the received optical and ultrasonic images to create a three-dimensional representation (or model) of a patient's mouth.” [0028]),
With regards to limitations: the mouth guard includes a first pocket configured to hold a transducer array and a second pocket configured to hold a coupling agent that is positioned between the transducer array and the one or more teeth, the coupling agent configured to couple the ultrasound from the transducer array to the one or more teeth, Kim further teaches: “…FIGS. 2-4, the three-dimensional intraoral scanner 100 includes a plurality of optical and ultrasonic sensors (e.g., optical and ultrasonic cameras) 130/135. The sensors 130/135 may be arranged on an inner surface of the outer U-shaped portion 110 and on an outer surface of the inner portion 120. In some embodiments, additional sensors 130/135 may be formed on upper and lower surfaces of the inner portion 120 to capture images of the hard palate (e.g., the roof), the floor of a patient's mouth, and the patient's tongue.” [0024]; “The ultrasonic sensors 135, however, are able to penetrate gum tissue by using ultrasonic waves, which reflect from the relatively hard or dense root structures but pass through the relatively soft gum tissue. Thus, by using the combination of optical and ultrasonic sensors 130/135, a composite three-dimensional representation of a patient's visible tooth structure and non-visible tooth root structure may be generated.” [0027]. See Figs. 2-4.
Kim does not explicitly teach a coupling agent.
Schafer in the field of oral treatment systems teaches: “…a thin layer of water or other fluid may be provided in the channel 154 to ensure acoustic coupling at regions of the ultrasound emitting portions 158a, 158b that may not directly contact the teeth. In one embodiment, the materials chosen for forming the device body 152 and any acoustic coupling medium may be transparent, translucent, or otherwise not unduly inhibiting of light transmission.” [0098]. See Fig. 15.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kim to include a coupling agent as taught in Schafer “…to establish indirect contact and maintain acoustic coupling between the ultrasound emitting portions 158a, 158b and the subject teeth during treatment.” (Schafer, [0097]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Pesach as applied to claim 1 above, and further in view of Johnson et. al. (U.S. 20160230007, August 11, 2016)(hereinafter, “Johnson”).
Regarding Claim 15, the combination of Kim and Pesach teach the claim limitations as noted above.
Kim does not teach: further comprising a registration system, wherein the mouth guard is deformable from a first shape to fit the patient mouth and the registration system is implemented to determine one or more deformation amounts of the mouth guard when it is deformed from the first shape, and further wherein the processor system is implemented to generate an ultrasound image based on the reflections of the ultrasound, the generation of the ultrasound image including to correct, based on the one or more deformation amounts, distortion caused by the deforming of the mouth guard.
Johnson in the field of oral treatment devices teaches: “…the tray can be customized (e.g., using a stone model of a user's teeth to register indentations in the tray corresponding to the user's unique dentition). Oral strips and trays are advantageously formulated so that it is difficult or impossible for a user to bite through the occlusal surface of the tray or strip in order to maintain a barrier to saliva.” [0068]; “Oral treatment tray or insert 100 can be used to provide a variety of different functions and may have different and/or varying thicknesses depending on its intended use. When used as a treatment tray to deliver a medicament or other active oral agent, tray 100 can be thin-walled, flexible, and readily adaptable to a person's teeth in order to provide good fit and comfort… the tray body 102 is able to register and maintain the unique shape and size of a person's unique dentition.” [0091]; “…the strip or sheet 750 was be used to register occlusal points during a dental examination procedure. Strip or sheet 750 can be made from a deformable wax-based material that can permanently deform and register occlusal points, which permits a dental practitioner to fashion a dental restoration in a proper fashion in order for the restored tooth to properly contact and function together with a corresponding tooth during chewing” [0113].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kim to include a registration system, wherein the mouth guard is deformable from a first shape to fit the patient mouth and the registration system is implemented to determine one or more deformation amounts of the mouth guard when it is deformed from the first shape, and further wherein the processor system is implemented to generate an ultrasound image based on the reflections of the ultrasound, the generation of the ultrasound image including to correct, based on the one or more deformation amounts, distortion caused by the deforming of the mouth guard as taught in Johnson “…to register indentations in the tray corresponding to the user's unique dentition…” (Johnson, [0068]).
Response to Arguments
Applicant’s arguments with respect to the amended claims have been considered but are moot because of the new grounds of rejection.
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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/AMAL ALY FARAG/ Primary Examiner, Art Unit 3798