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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 22, 2025 has been entered.
Claim Rejections - 35 USC § 112
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 15-17 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.
With respect to claim 15, the preamble of the claim is directed towards a system “for the monitoring of an orthodontic treatment”, however, the body of the claim is also directed to a system that is configured to collect data and design the treatment. It is unclear what the applicant is trying to claim due to the preamble being more narrow than what is being claimed. It is suggested that the applicant amend preamble to be directed towards a system to clarify what is being claimed
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a process and system for the monitoring of an orthodontic treatment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only require obtaining data, analyzing the data to determine an orthodontic treatment, obtain more data and compare the newly obtained data with the planned treatment and the system to carry out the method.
Step 1: Claims 15-17 are directed to “a system for the monitoring of an orthodontic treatment’, that is directed towards to a generic system, including a smartphone and computer to obtain a digital representation of the teeth, plan a treatment and compare images. The “system” is within the 35 U.S.C. 101 statutory category of a “machine” (MPEP 2106.03), but falls into the judicial exception (MPEP 2106.06).
Step 2A: In regards to the claimed invention, the claimed invention is directed to an abstract idea (MPEP 2106.04(a)) without reciting additional elements that amount to significantly more than the judicial exception (MPEP 2106). The claimed invention is directed towards a mental process and organizing human activity, both of which are abstract ideas. The concepts that are capable of being performed in the human mind including observations, evaluations and judgements. Such that the claimed imaging may be done mentally, such that the dentist and/or patient draws the teeth in the target position and the updated position and then the models are mentally compared. The claimed smartphone and scanner are generic and well known in the art. It is noted that dentist have long practiced their art/trade of orthodontics well before the advent of computers and are most certainly capable of comparing target and updated models. It is noted that there is no claimed transformation of information. It is suggested that if support is provided the applicant include a manufacturing machine that manufactures the appliance in the claimed system to overcome the rejection.
Step 2B: In regards to the claims, the claims are directed towards generic computer elements, imaging elements, and manufacturing elements. The mere recitation in the claims of a generic conventional processing unit (phone) that is used in a conventional manner to perform conventional computer functions that are well understood and routine does not amount to “significantly more” than the judicial exception. The claims do not go beyond using a generic computer, imaging device, and manufacturing device to “determine” and “calculate” numerical values based on mathematical algorithms. It is noted that the manufacturing device is not related to the designed expanders and is therefore generic and not configured to manufacture the designed expanders. The analysis of data in a particular field and the stating those functions in general terms, without limiting them to technical means for performing the functions is an abstract idea and does not meet the requirements of 365 U.S.C. 101. Nothing in the claims or specification requires anything more than a conventional prior art computer for analyzing number according to a mathematical algorithm. The claimed system falls with the judicial exception to patent eligible subject matter of an abstract idea without significantly more. See above regarding suggested claim amendments to overcome the rejection.
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(s) 1, 3-4, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tod et al. (2016/0228213) in view of Kitching et al. (2008/0306724) in view of Shanjani et al. (2018/0153648) in view of Farkash et al. (2021/0244502).
Tod teaches a process for initiation and monitoring and implementing an orthodontic treatment, comprising collecting initial data of a subject requiring orthodontic treatment by an online questionnaire during an initial digital consultation, the initial data comprising at least a digital image of the subject’s teeth imaged using a smartphone application (see fig. 3, par. 43), a description of an orthodontic problem and personal information regarding the subject (see abstract, pars. 11-13, 43, 47-48),selecting the subject that fulfills requirement for the orthodontic treatment based on said initial data of said subject, wherein the requirement comprise the presence of an intra-oral condition in the need of treatment (pars. 22-23, 43, 44-50, 57, fig. 2), initiating initial orthodontic treatment for said subject from a practitioner (pars. 50, 64, 66, claim 23, such that treatment is sought), wherein a follow up of said initial orthodontic treatment scheme in said subject is performed at least partially in a digital manner, comprising one or more digital treatment consults characterized in that during the digital treatment consult, the subject provides additional intra-oral image data imaged using the smartphone application via a digital platform to a practitioner (see pars. 45, 61-65). Tod teaches the invention as substantially claimed and discussed above including consulting with an orthodontic as to if treatment should be sought (see par. 50), however, does not specifically teach the orthodontic treatment is a rapid palatal expansion treatment, selecting the subject that fulfills requirement for the orthodontic treatment based on said initial data of said subject, wherein said requirements comprise the presence of an intra-oral condition in need of the RPE treatment with an initial palatal expander and one or more additional palatal expanders to be used after the initial palatal expander, the presence of which is established by a practitioner based on the digital image of the subject’s teeth, obtaining further data from said subject during an in-person consultation wherein said further data, comprises intra-oral image data in the form of a scanned image generated from the oral cavity of said subject, said intra-oral image data being obtained during the in-person consultation by an intra-oral digital scanner, analyzing said intra-oral image data by converting the scanned image of orthodontic anatomy of the subject into a digital three-dimensional model of malocclusions of the subject, and providing an initial orthodontic treatment scheme for said subject based on said analysis of said intra-oral image data, said initial orthodontic treatment scheme comprising a treatment in order to obtain a desired orthodontic result and an orthodontic progression estimate; designing and manufacturing the initial palatal expander, wherein said designing is based on the analysis of the intra-oral image data, wherein the initiating the initial orthodontic treatment scheme is done by implementing the initial palatal expander, wherein the follow up and/or the implementation of said initial orthodontic treatment scheme in said subject further comprising wherein said additional intra-oral image data uploaded to said digital platform is compared with said orthodontic progression estimate, and said initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on said matching comparison, designing and manufacturing the one or more additional palatal expanders to implement the amended orthodontic treatment scheme, initiation the amended orthodontic treatment scheme by implementing the one or more additional palatal expanders and wherein the additional intra-oral image data uploaded to said digital platform is compared with the orthodontic progression estimate automatically using a machine learning model, and the machine learning model determines whether said initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on said comparison..
Kitching teaches a method for initiating and monitoring an orthodontic treatment comprising the following steps: collecting initial data of a subject requiring orthodontic treatment by means of an online questionnaire during an initial consultation (par. 38, such that the on-line treatment form being the questionnaire), selecting the subject that fulfills requirement for the orthodontic treatment based on the initial data of the subject, wherein the requirement comprises the presence of an intra-oral condition in the need of treatment (par. 38, such that the data is reviewed and a treatment plan is made for the patient, such that if the user did not need treatment, then a treatment plan would not be created, par. 50 qualification for a specific treatment service), obtaining further data from the subject during an in-person consultation wherein the further data comprises intra-oral image data in the form of a scanned image generated from the oral cavity of the subject (par. 34), said intra-oral image data being obtained during the in-person consultation by an intra-oral digital scanner (pars. 34, 40), analyzing the intra oral image data by converting the scanned image of orthodontic anatomy of the subject into a digital three-dimensional model of malocclusion of the subject (pars. 39-42, 73 fig. 2a, 10) and providing an initial orthodontic treatment scheme for the subject based on the analysis of the intra oral image data, the initial orthodontic treatment scheme comprising treatment in order to obtain a desired orthodontic result and an orthodontic progression (par. 35), designing and manufacturing an initial appliance, wherein the designing is based on the analysis of the intra-oral image data and the orthodontic progression estimate (pars. 38-43, 46), initiating the initial orthodontic treatment scheme for the subject by implement that initial alinger (par. 46, such that the first alinger is provided to the patient), wherein a follow up and/or the implementation of the initial orthodontic treatment scheme in the subject is performed at least partially in a digital manner, comprising one or more digital treatment consultations characterized in that during the one or more digital treatment consultations, said subject provides additional intra-oral image data via a digital platform to a practitioner and wherein the additional intra-oral image data is uploaded to the digital platform is compared with the orthodontic progression estimate, and the initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on the comparison (see pars. 35-36, 37-38, such that the scan/info is submitted online, i.e. a digital manner and processed and a digital consult such as the service terminal is consulted which is a remote digital consultation), designing and manufacturing the one or more additional appliances to implement the amended orthodontic treatment (par. 46, 61, 72). It would have been obvious to one having ordinary skill in the art to modify the steps of Tod to continue with the original treatment if the teeth are on track or to amend the treatment if the teeth are off track as taught by Kitching in order to ensure the desired treatment outcome is achieved. Tod/Kitching teaches the invention as substantially claimed and discussed above however, does not specifically teach the orthodontic treatment is a rapid palatal expansion treatment, wherein the requirements when selecting the subject comprise the presence of an intra-oral condition in need of the RPE treatment with an initial palatal expander and one or more additional palatal expanders to be used after the initial palatal expander, wherein the designing and manufacturing is designing and manufacturing the initial palatal expander and the one or more additional palatal expanders, wherein initiating the initial orthodontic treatment scheme is by implementing the initial palatal expander, and initiating the amended orthodontic treatment scheme is by implementing the one or more additional palatal expanders and wherein the additional intra-oral image data uploaded to said digital platform is compared with the orthodontic progression estimate automatically using a machine learning model, and the machine learning model determines whether said initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on said comparison.
Shanjani teaches a process for initiating, monitoring, and implementing an orthodontic treatment, wherein the orthodontic treatment is a rapid palatal expansion treatment comprising selecting the subject hat fulfills requirement for the orthodontic treatment, wherein the requirement comprises the presence of an intra-oral condition in the need of the RPE treatment with an initial palatal expander and one or more additional palatal expander to be used after the initial palatal expander (see abstract, pars. 10, 13, 157, 193, such that a subject is selected based on that they have a condition that needs RPE treatment), obtaining further data from the subject during an in-person consultation wherein the further data comprises intra-oral image data in the form of a scanned image generated from the oral cavity of said subject (pars.19, 157, 189), analyzing the intra-oral image by converting the scanned image of the orthodontic anatomy of the subject into a digital three-dimensional model of malocclusions of the subject (par. 196) and providing an initial orthodontic treatment scheme for the subject based on the analysis of said intra-oral image data, the initial orthodontic treatment scheme comprising a treatment in order to obtain a desired orthodontic result and an orthodontic progression estimate (pars. 147, 158, 194-195), designing and manufacturing the initial palatal expander, wherein the designing is based on the analysis of the intra oral image data (par. 159, 194), initiating the initial orthodontic treatment scheme for the subject by implementing the initial palatal expander (par. 159 such that the user applies the expander), wherein a follow up of the initial orthodontic treatment scheme in the subject is performed at least partially in a digital manner, wherein an additional intra-oral image data is provided, wherein the additional intra-oral image data is compared with the orthodontic progression estimate, and the initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on the comparison (see par. 159, such that scans are taken during treatment, i.e. additional intra oral data, and the treatment is adjusted by redesigning the expanders such that it is compared to the planned treatment and adjusted from that in order to achieve the desired final outcome). It would have been obvious to one having ordinary skill in the art to modify the orthodontic treatment taught by Tod/Kitching to include rapid palatal expansion as taught by Shanjani in order to ensure proper orthodontic treatment for a patient who’s mouth needs to be expanded in order to create space for more permanent teeth (see par. 158 and193 of Shanjani). Such that Shanjani teaches the movement of the teeth and the expansion of the palate. Tod/Kitching/Shanjani teaches the invention as substantially claimed and discussed above in detail, however does not specifically teach wherein the additional intra-oral image data uploaded to said digital platform is compared with the orthodontic progression estimate automatically using a machine learning model, and the machine learning model determines whether said initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on said comparison.
Farkash teaches a process for initiating, monitoring and implementing orthodontic treatment comprising obtaining data from the subject during an in-person consolation wherein the data comprises intra-oral image data in the from of a scanned image generated from the oral cavity of the subject, the intra-oral image data being obtained during the in-person consolation by an intra-oral digital scanner (par. 73), analyzing the intra-oral image data by converting the scanned image of the orthodontic anatomy of the subject into a digital three-dimensional model of malocclusions of the subject (par. 73), and providing an initial orthodontic treatment scheme for the subject based on the analysis of the intra-oral image data, the initial orthodontic treatment scheme comprising a treatment in order to obtain a desired orthodontic result and an orthodontic progression estimate (par. 73), designing and manufacturing the initial aligner, wherein the designing is based on the analysis of the intra-oral image data and the orthodontic progression estimate (pars. 4, 67, 73), initiating the initial orthodontic treatment scheme, wherein a follow up is performed in a digital manner, comprising one or more digital treatment consolation characterized in that during the one or more digital treatment consolation (pars. 17, 102), the subject provide additional intra-oral image data imaged using the smartphone application via a digital platform to a practitioner (pars. 17, 35, 102) and wherein the additional intra-oral image data uploaded to the digital platform is compared with the orthodontic progression estimate automatically using a machine learning model, and the machine learning model determines whether the initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on said comparison (pars. 8, 29, 42, 72, 82-83, claim 19, fig. 1a). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the comparison taught by Tod/Kitching/Shanjani to use machine learning as taught by Farkash in order to provide an algorithm that can improve accuracy over time.
With respect to claim 3, Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above including Kitching further teaching the orthodontic progression estimate comprises one or more digital orthodontic models of the subject’s orthodontic anatomy, the digital orthodontic models comprises a model of the subject’s final desired orthodontic result and one or more models of intermediate orthodontic results (pars. 33-34, 36, 43).
With respect to claim 4, Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above including Tod further teaching wherein a morphing technique is performed to render an immediate result simulation to display the desired orthodontic result (Par. 66, such that it shows the treatment options). Kitching further teaches a morphing technique is performed to render an immediate result simulation to display the desired orthodontic result and the orthodontic progression estimate (pars. 44, 50, 55). It would have been obvious to one having ordinary skill in the art to modify Tod to include displaying the orthodontic progression estimate to allow the user to view the entire orthodontic treatment before selecting the desired treatment.
With respect to claim 7, Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above including Tod further teaching wherein the smartphone used with the smartphone application includes a built-in camera (par. 43)
With respect to claim 9, Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above including Tod further teaching wherein the initial data is collected through the online questionnaire by a smartphone application or a web application (par. 43).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tod et al. (2016/0228213) in view of Kitching et al. (2008/0306724) in view of Shanjani et al. (2018/0153648) in view of Farkash et al. (2021/0244502) as applied to claim 1 above, and further in view of Brawn (2012/0148975).
Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above, however, does not specifically teach wherein the initial orthodontic treatment scheme or the amended orthodontic treatment scheme is accelerated by one or more accelerating orthodontic devices, wherein each of said accelerating orthodontic device accelerated tooth movement by soft pulse technology or photobiomodulation.
Brawn teaches an orthodontic treatment scheme which is accelerated by using an accelerating orthodontic device which accelerates tooth movement by photobiomodulation (see abstract, pars. 2, 105-108). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the method taught by Tod/Kitching/Shanjani/Farkash to include the accelerating device taught by Brawn in order to assist in accelerating the orthodontic treatment.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tod et al. (2016/0228213) in view of Kitching et al. (2008/0306724) in view of Shanjani et al. (2018/0153648) in view of Farkash et al. (2021/0244502) as applied to claim 1 above, and further in view of Sabina et al. (2019/0231492).
Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above, however, does not specifically teach the machine learning model is verified by a certified practitioner.
Sabina teaches a method of using machine learning and verifying the results of the machine learning (see par. 136, i.e. automatic but with manual assistance to verify/confirm including systems that have been trained by machine learning). It would have been obvious to one having ordinary skill in the art to modify the method taught by Tod/Kitching/Shanjani/Farkash to include the step of verifying the machine learning results in order to prevent errors.
Claim(s) 7 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tod et al. (2016/0228213) in view of Kitching et al. (2008/0306724) in view of Shanjani et al. (2018/0153648) as applied to claim 1 above, and further in view of Salah et al. (2020/0405447).
Tod/Kitching teaches the invention as substantially claimed and discussed above, however, does not specifically teach in addition to the effect of the initial orthodontic treatment scheme or the amended orthodontic treatment scheme, additional data related to oral hygiene and periodontal diseases are monitored and wherein after the initial orthodontic treatment scheme or the amended orthodontic treatment scheme, the amended orthodontic treatment scheme, the additional intra-oral image data is obtained by the subject and processed by an online platform to prevent relapse.
Salah teaches a process for initiating and monitoring an orthodontic treatment, comprising the following steps obtaining further data form the subject during a physical consultation wherein the further data comprises intra oral image data generated form the oral cavity of the subject (pars. 134-135, such that the 3D data is the initial data), analyzing the intra oral image data and providing an initial orthodontic treatment scheme for the subject based on the analysis of the intra oral image data, the initial orthodontic treatment scheme comprising treatment steps in order to obtain a desired orthodontic result and an orthodontic progression estimate (see pars. 130-132, such that the 3D models are the progression estimate and the final model being the result), and initiating the initial orthodontic treatment scheme for the subject (pars. 130-132, 134-135), wherein a follow up and/or implementation of the initial orthodontic treatment scheme in said subject is performed at least partially in a digital manner, comprising one or more digital treatment consult characterized in that during the digital treatment consult, the subject provide additional intra-oral image data via a digital platform to a practitioner and wherein the additional intra-oral image data uploaded to the digital platform is compared with the orthodontic progression estimate (see pars. 130-132, 136-137, 147, 156-157).
Salah further teaches with respect to claim 13, wherein in addition to the effect of the initial orthodontic treatment scheme or the amended orthodontic treatment scheme, additional data related to oral hygiene and periodontal diseases are monitored (see pars. 142, 144) and with respect to claim 14, wherein after the initial orthodontic treatment scheme or the amended orthodontic treatment scheme, the additional intra-oral image data is obtained by the subject and processed by an online platform to prevent relapse by comparing the additional intra-oral image data after the initial orthodontic treatment scheme or the amended orthodontic treatment scheme to the updated additional intra-oral image data (pars. 27-32, 53, 69, 13). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Tod/Kitching/Shanjani/Farkash to include the steps of monitoring other conditions and preventing relapse as taught by Salah in order to provide the proper treatment to the patient. Such that if gingivitis is present, it can be treated and the desired movement of the teeth is maintained.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tod et al. (2016/0228213) in view of Kitching et al. (2008/0306724) in view of Shanjani et al. (2018/0153648) in view of Farkash et al. (2021/0244502).
Tod teaches a system for the monitoring of an orthodontic treatment, the system comprising a smartphone application for obtaining intra-oral image data by a subject (pars. 43), a cloud for online storage and processing on the intra-oral image data (pars. 44-45, such that the data is accessed remotely over the internet), a dashboard comprising data of the subject accessible for a practitioner (pars. 45, 61), a program configured to analyze the intra-oral image data provided by the subject in need of the orthodontic treatment to said smartphone application in view of an orthodontic progression estimate comprising one or more orthodontic models of said subject (pars. 43, 51-53, 57, 61 66), wherein the system is configured to collect initial data of a subject requiring orthodontic treatment by an online questionnaire during an initial digital consultation by the smartphone application, enabling a first preselection of subjects suited for the orthodontic treatment, wherein the initial data comprising at least a digital image of the subject’s teeth, a description of an orthodontic problem and personal information regarding the subject (see abstract, pars. 11-13, 43, 47-48, such that it can enable preselection), select the subject with the presence of an intra-oral condition in the need of treatment (pars. 22-23, 43, 94-50, 57, fig. 2), perform one or more follow ups of said initial orthodontic treatment scheme in said selected subject in a digital manner, providing further intra-oral image data via a digital platform, wherein further intra-oral image data obtained during the one or more digital treatment consultations is obtained by the smartphone application on a selected subject’s smartphone (see pars. 43, 23-25, claim 23). Tod teaches the invention as substantially claimed and discussed above, however, does not specifically teach the orthodontic treatment is a rapid palatal expansion treatment, the program is a machine learning model, the system further comprising an intra-oral digital scanner, and a manufacturer of palatal expanders, wherein the system is configured to obtain further, the subject is selected such that there is the presence of an intra-oral condition in need of the RPE treatment, obtain further data from said subject during an physical consultation wherein said further data comprises intra-oral image data of the selected subject’s orthodontic anatomy generated form the oral cavity of the selected subject, the intra-oral image data being obtained during the physical consultation by the intra-oral digital scanner, analyze said intra-oral image data by converting the scanned image of orthodontic anatomy of the subject into a digital three-dimensional model of malocclusions of the subject, and provide an initial orthodontic treatment scheme for said subject based on said analysis of said intra-oral image data, said initial orthodontic treatment scheme comprising treatment steps in order to obtain a desired orthodontic result and an orthodontic progression estimate, the progression estimate used to develop an initial palatal expander design by using software and sending the initial palatal expander design to a manufacturer of palatal expanders to produce the selected subject’s tailored initial palatal expander, perform one or more follow ups of said initial orthodontic treatment scheme in said selected subject in a digital manner, comprising one or more digital treatment consultations wherein during the digital treatment consultations, the selected subject provides further intra-oral image data via a digital platform to a practitioner, wherein said further intra-oral data obtained during the one or more digital treatment consultations is obtained by the smartphone application on a selected subject’s smartphone and wherein said further intra-oral image data provided to the digital platform is compared automatically with the orthodontic progression estimate via the machine learning model and wherein said machine learning model determines whether the initial orthodontic treatment scheme is maintained or amended based on a matching comparison by the machine learning model, and wherein the amended orthodontic treatment scheme comprises amended treatment steps in order to obtain the desired orthodontic result and an amended orthodontic progression estimate, the amended progression estimate used to develop one or more additional palatal expander designs by using software and sending the one or more palatal expander design to a manufacture of palatal expanders to produce the selected subject’s tailored one or more additional palatal expanders
Kitching teaches a system for the monitoring of an orthodontic treatment comprising a dashboard comprising data of the subject accessible practitioner (see fig. 3B-3C, par. 38, such that the data transmitted from one practitioner to another), an intra-oral scanner (par. 84, 86), and a manufacturer of palatal expanders 723 (par. 86), wherein the system is configured to collect initial data of a subject requiring orthodontic treatment by an online questionnaire during an initial consultation (par. 38, such that the on-line treatment form being the questionnaire), enabling a first preselection of the subjects suited for the orthodontic treatment (such that it enables the preselection), wherein the initial data comprises at least a digital image of the subject’s teeth, a description of the orthodontic problem, and personal information regarding the subject (see fig. 3c, step 262, par. 38), select a subject with the presence of an intra-oral condition in the need of treatment (par. 38, such that the data is reviewed and a treatment plan is made for the patient, such that if the user did not need treatment, then a treatment plan would not be created, par. 50 qualification for a specific treatment service), obtain further data from the subject during an physical consultation wherein the further data comprises intra-oral image data in the form of a scanned image generated from the oral cavity of the subject(par. 34), said intra-oral image data being obtained during the in-person consultation by the intra-oral digital scanner (pars. 34, 40), analyze the intra oral image data by converting the scanned image of orthodontic anatomy of the subject into a digital three-dimensional model of malocclusion of the subject (pars. 39-42, 73 fig. 2a, 10) and provide an initial orthodontic treatment scheme for the subject based on the analysis of the intra oral image data, the initial orthodontic treatment scheme comprising treatment steps in order to obtain a desired orthodontic result and an orthodontic progression (par. 35), the progression estimate used to develop an initial appliance design by using software and sending the initial appliance deign to a manufacture to produce the selected subject’s tailored initial appliance (pars. 38-42, 46), perform one or more follow ups of the initial orthodontic treatment scheme in the subject in a digital manner, comprising one or more digital treatment consultations wherein during the digital treatment consultations, a further intra-oral image data via a digital platform is provided to a practitioner, wherein the further intra-oral image data provided in the digital platform is compared automatically with the orthodontic progression estimate via a program and wherein the initial orthodontic treatment scheme is maintained or amended based on a machining comparison by the program (see pars. 35-36, 37-38, 70-71, such that the scan/info is submitted online, i.e. a digital manner and processed and a digital consult such as the service terminal is consulted which is a remote digital consultation) and wherein the amended orthodontic treatment scheme comprises amended treatment steps in order to obtain the desired orthodontic result and an amended orthodontic progression estimate, the amended progression estimate used to develop one or more additional appliance designs by using software and sending the one or more appliance design to a manufacturer of appliances to produce the selected subject’s tailored appliances (par. 46, 61, 72). It would have been obvious to one having ordinary skill in the art to modify the steps of Tod to continue with the original treatment if the teeth are on track or to amend the treatment if the teeth are off track as taught by Kitching in order to ensure the desired treatment outcome is achieved. Tod/Kitching teaches the invention as substantially claimed and discussed above however, does not specifically teach the system includes a machine learning model, the orthodontic treatment is a rapid palatal expansion treatment, wherein the requirements when selecting the subject comprise the presence of an intra-oral condition in need of the RPE treatment with an initial palatal expander and one or more additional palatal expanders to be used after the initial palatal expander, wherein the designing and manufacturing is designing and manufacturing the initial palatal expander and the one or more additional palatal expanders, wherein initiating the initial orthodontic treatment scheme is by implementing the initial palatal expander, and initiating the amended orthodontic treatment scheme is by implementing the one or more additional palatal expanders and wherein the further intra-oral image data provided to the digital platform is compared automatically with the orthodontic progression estimate via the machine learning model, and wherein the machine learning model determines whether the initial orthodontic treatment scheme is maintained or amended based on the matching comparison by the machine learning model.
Shanjani teaches a system for the monitoring of an orthodontic treatment, wherein the orthodontic treatment is a rapid palatal expansion treatment, the system comprising a dashboard comprising data of the subject accessible for a practitioner (par. 29 such that it can access the models) and an intra oral scanner (par. 157), the system is configured to select the subject that fulfills requirement for the orthodontic treatment, wherein the requirement comprises the presence of an intra-oral condition in the need of the RPE treatment with an initial palatal expander and one or more additional palatal expander to be used after the initial palatal expander (see abstract, pars. 10, 13, 157, 193, such that a subject is selected based on that they have a condition that needs RPE treatment), obtain further data from the subject during an in-person consultation wherein the further data comprises intra-oral image data in the form of a scanned image generated from the oral cavity of said subject (pars.19, 157, 189), analyze the intra-oral image by converting the scanned image of the orthodontic anatomy of the subject into a digital three-dimensional model of malocclusions of the subject (par. 196) and provide an initial orthodontic treatment scheme for the subject based on the analysis of said intra-oral image data, the initial orthodontic treatment scheme comprising a treatment in order to obtain a desired orthodontic result and an orthodontic progression estimate (pars. 147, 158, 194-195), designing and manufacturing the initial palatal expander, wherein the designing is based on the analysis of the intra oral image data (par. 159, 194), initiating the initial orthodontic treatment scheme for the subject by implementing the initial palatal expander (par. 159 such that the user applies the expander), wherein a follow up of the initial orthodontic treatment scheme in the subject is performed at least partially in a digital manner, wherein an additional intra-oral image data is provided, wherein the additional intra-oral image data is compared with the orthodontic progression estimate, and the initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on the comparison (see par. 159, such that scans are taken during treatment, i.e. additional intra oral data, and the treatment is adjusted by redesigning the expanders such that it is compared to the planned treatment and adjusted from that in order to achieve the desired final outcome). It would have been obvious to one having ordinary skill in the art to modify the orthodontic treatment taught by Tod/Kitching to include rapid palatal expansion as taught by Shanjani in order to ensure proper orthodontic treatment for a patient who’s mouth needs to be expanded in order to create space for more permanent teeth (see par. 158 and193 of Shanjani). Such that Shanjani teaches the movement of the teeth and the expansion of the palate. Tod/Kitching/Shanjani teaches the invention as substantially claimed and discussed above, however, does not specifically teach a machine learning model wherein the further intra-oral image data provided to the digital platform is compared automatically with the orthodontic progression estimate via the machine learning model, and wherein the machine learning model determines whether the initial orthodontic treatment scheme is maintained or amended based on the matching comparison by the machine learning model.
Farkash teaches a system for an orthodontic treatment, the system comprising a smartphone application for obtaining intra-oral image data by a subject (par. 17), a cloud for online storage and processing of the intra oral image data (pars. 37, 85), a machine leaning model configured to analyze the intra-oral image data provided by the subject in need of the orthodontic treatment to said smartphone application in view of an orthodontic progression estimate comprising one or more orthodontic models of said subject (pars. 8, 29, 42, 72-73, 82-83), and an intra-oral digital scanner (par. 73), wherein the system is configured to obtain further data from the subject during an physical consolation wherein the data comprises intra-oral image data in the form of a scanned image generated from the oral cavity of the subject, the intra-oral image data being obtained during the physical consolation by an intra-oral digital scanner (par. 73), analyze the intra-oral image data by converting the scanned image of the orthodontic anatomy of the subject into a digital three-dimensional model of malocclusions of the subject (par. 73), and provide an initial orthodontic treatment scheme for the subject based on the analysis of the intra-oral image data, the initial orthodontic treatment scheme comprising a treatment in order to obtain a desired orthodontic result and an orthodontic progression estimate (par. 73), preform one or more follow ups of said initial orthodontic treatment scheme in said selected subject in a digital manner, comprising one or more digital treatment consolations wherein during the digital treatment consolation, the selected subject provides further intra-oral image data via a digital platform to a practitioner, wherein said further intra-oral data obtained during said one or more digital treatment consultation is obtained by the smartphone application on a selected subject’s smartphone (pars. 17, 35, 102), wherein the additional intra-oral image data uploaded to the digital platform is compared with the orthodontic progression estimate automatically using a machine learning model, and the machine learning model determines whether the initial orthodontic treatment scheme is maintained or amended to thereby provide an amended orthodontic treatment scheme based on said comparison (pars. 8, 29, 42, 72, 82-83, claim 19, fig. 1a), and wherein the amended orthodontic treatment scheme comprises amended treatment steps in order to obtain the desired orthodontic result (par. 78, 82-83). It would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify the comparison taught by Tod/Kitching/Shanjani to use machine learning as taught by Farkash in order to provide an algorithm that can improve accuracy over time.
With respect to claim 16, Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above, Tod further teaches wherein the system comprises a communication system for sending messages to the subject (par. 63).
With respect to claim 17, Tod/Kitching/Shanjani/Farkash teaches the invention as substantially claimed and discussed above, Tod further teaches wherein the smartphone application comprises instructions for generating and storing intra-oral cavity data of the subject (pars. 51, 61-62, see figs. 3-10, such that the app guide the user through the process).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed November 14, 2025 have been fully considered but they are not persuasive. The applicant argues that the amendments to claim 15 overcome the 101 rejection since they requires the system including a manufacturer of palatal expanders”, however the limitation is a generic machine, just like the claimed scanner and it not related to the claimed expanders. As suggested above in the rejection, the claim should be amended to include a manufacturing machine (if supported by the specification) to manufacture the designed appliance to overcome the rejection.
Conclusion
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/HEIDI M EIDE/Primary Examiner, Art Unit 3772 2/23/2026