DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/26/2025 and 04/01/2026 were filed after the mailing date of the application on 09/03/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Rejections based 35 U.S.C. 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. In accordance with the “2019 Revised Patent Subject Matter Eligibility Guidance,” issued January 7, 2019 the pending claims are analyzed as follows —
Step 1 - In regard to claims 1-20 directed to “A system for predicting palatal geometry” and “A system for designing a dental appliance for expanding a patient's palate”. The “system/method” are within the 35 U.S.C. 101 statutory category of a “process” (MPEP 2106.03), but falls into the judicial exception (MPEP 2106.04).
Step 2A —In regard to claims 1-20, 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 2106.05). The claimed invention is directed to a mental process — concepts that are capable of being performed in the human mind — including observations, evaluations and judgements. More particularly, the steps of “identify a plurality of reference points within one or more three-dimensional (3D) dental models of a patient; determine one or more tooth measurements based on the plurality of reference points; determine, based on the one or more tooth measurements” are capable of being done mentally (a dentist views a patient’s oral cavity tissues envisioning a 3D image of the structure, which is stored digitally in a computer memory and predicts the changes caused to said tissues by a series of planned orthodontic appliances); the steps of “a recommended palatal expansion amount for a palatal expansion treatment plan for the patient; and provide, to a user device, the recommended palatal expansion amount”; may be done mentally (the dentist mentally virtually fits planned orthodontic appliances for each stage of the treatment and predicts the changes that they would cause to the tissues). It is further noted that dentists have long practiced their trade/art of determining mentally what orthodontic appliances are needed for a patient and how they are going to shape the patient’s tissues—well before the advent of computers — and are most certainly capable of envisioning and mentally determining the shapes and arrangements of dental appliances necessary to accomplish a desired appearance. Additionally, there are no additional elements recited that integrate the exception into a practical application, i.e. manufacturing.
Step 2B — In regard to claims 1-20, the claimed steps are all algorithms capable of being performed mentally and represent nothing more than concepts related to performing mathematical calculations which fall within the judicial exception. Implicit in the claimed invention is the intended use of a computing or data processing device, however, there is no disclosure in the written description that the processing unit is anything more than a generic component, nor is there any disclosure that the method improves the manner in which the processing unit operates. The mere recitation in the claims of a generic conventional processing unit 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 “determining” and “calculating” numerical values based on mathematical algorithms with a standard generic computer.
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 35 U.S.C. 101. The claims do not require that the method be implemented by a particular machine and they do not require that the method particularly transform a particular article. The claims set forth a process of analyzing information of a specific content and are not directed to any particularly asserted inventive technology for performing those functions. Nothing in the claims or specification requires anything more than a conventional prior art computer for analyzing numbers according to a mathematical algorithm. The claimed system and method fall with the judicial exception to patent eligible subject matter of an abstract idea without significantly more. See Elec. Power Grp., LLC v. Alstom S.A., 119 USPQ2d 1739 (Fed. Cir. 2016) for further guidance.
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.
Claim(s) 4-6, 11-14 and 15-17 is/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.
Claims 4-6, 11-12 and 15-17 recite “is further to”; it is unclear if this is meant to state that the device is further programmed to, or if it is just capable of being programmed to perform the claim computer method steps (algorithmic steps). For the purpose of examination this limitation is interpreted as a system being capable of being programmed to perform he claimed steps.
Claims 13-14 are rejected by virtue of their dependency on claim 12.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-14 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (US 20180153649 A1).
Regarding claim 1, Wu discloses a system ([0011] and [0111]) comprising: a memory; and a processing device to execute instructions from the memory ([0111]) to: identify a plurality of reference points within one or more three-dimensional (3D) dental models of a patient (since a digital model of the patient's oral cavity in an initial position is received, the digital model may comprise one or more of: a digital model of the patient's teeth, gingiva, palate, and the patient's lower jaw; optionally, segmenting the digital model of the patient's oral cavity into a palate model and/or a tooth model and/or a gingiva model; adjusting the digital model from the initial position to a final position in which the palate is expanded by morphing the digital model to reflect an orthopedic expansion of the patient's midline suture and an orthodontic movement of the teeth within the patient's jaw [0013]; therefore reference points must be identified by the system in order to segment the digital model of the patient's oral cavity; see also, control points in [0135]); determine one or more tooth measurements based on the plurality of reference points (since the system comprises manipulation of the model can be constrained obtained the anatomy of jaw and bone, and/or by measurement and data analysis of real treatment outcome [0123] and for instance the distance of movement between molars may be measured [0131]); determine, based on the one or more tooth measurements, a recommended palatal expansion amount for a palatal expansion treatment plan for the patient ([0133]); and provide, to a user device, the recommended palatal expansion amount ([0134] and see user interface may present the user with a graphic display [0040]).
Regarding claim 2, Wu discloses wherein the one or more 3D dental models comprise a first 3D dental model of an upper jaw and a second 3D dental model of a lower jaw ([0013]), wherein the plurality of reference points comprises a first reference point on the first 3D dental model of the upper jaw and a second reference point on the second 3D model of the lower jaw (since the control points selected may include the crown center and root center of all teeth and/or sample points in the midline/middle plane [0135]), and wherein the second 3D dental model corresponds to one of an initial stage of a treatment plan for the patient, an intermediary stage of the treatment plan for the patient, or a final stage of the treatment plan for the patient (see: receiving a digital model of the patient's oral cavity in an initial position; adjusting the digital model from the initial position to a final position in which the palate is expanded by morphing the digital model to reflect an orthopedic expansion of the patient's midline suture (and optionally an orthodontic movement of the patient's teeth within the patient's jaw); generating a palatal expander model corresponding to each intermediate position of a plurality of intermediate positions of the digital model between the initial position and the final position [0011]).
Regarding claim 3, Wu discloses wherein each of the plurality of reference points corresponds to a point on a tooth of the patient (see control points in [0127] and [0135]).
Regarding claim 4, Wu discloses wherein the processing device is further to: receive user input selecting at least a subset of the plurality of reference points (since a full 3D model that may be manipulated, for example control points may be placed on the teeth (crowns and/or centers) to control tooth movement and/or suture points to control the suture opening [0127]).
Regarding claim 6, Wu discloses wherein the processing device is further to: perform image processing on a first 3D dental model of the one or more 3D dental models to determine a location of at least one of the plurality of references points within the first 3D dental model (see morphing the 3D data, regulated by control points [0127]).
Regarding claim 7, Wu discloses wherein a first tooth measurement of the one or more tooth measurements represents a distance between a first reference point on a first tooth and a second reference point on a second tooth of the one or more 3D dental models of the patient (since for instance the distance of movement between molars may be measured [0131] and the reference points/control points may be placed on the teeth (crowns and/or centers) to control tooth movement and/or suture points to control the suture opening [0127]).
Regarding claim 8, Wu discloses wherein the first reference point corresponds to a tooth cusp, wherein the first tooth corresponds to an upper-left first molar of an upper jaw, wherein the second reference point corresponds to a second tooth cusp, and wherein the second tooth corresponds to a lower-left first molar of a lower jaw (since the control points selected may include the crown center and root center of all teeth [0135]).
Regarding claim 9, Wu discloses wherein the first reference point corresponds to a tooth cusp, wherein the first tooth corresponds to an upper-right first molar of an upper jaw, wherein the second reference point corresponds to a second tooth cusp, and wherein the second tooth corresponds to a lower-right first molar of a lower jaw (since the control points selected may include the crown center and root center of all teeth [0135]).
Regarding claim 10, Wu discloses wherein the first reference point represents a first midpoint between a lingual-distal cusp and a lingual-mesial cusp, and wherein the second reference point represents a second midpoint between a buccal-distal cusp and a buccal-mesial cusp (the control points selected may include the crown center and root center of all teeth and/or sample points in the midline/middle plane (see, e.g., FIG. 21C) [0135]).
Regarding claim 11, Wu discloses wherein the one or more 3D dental models comprise one or more first 3D dental models of an upper jaw and a second 3D dental model of a lower jaw ([0013]), and wherein to determine the recommended palatal expansion amount, the processing device is further to: identify a plurality of treatment stages of the palatal expansion treatment plan (e.g. [0119]), wherein each treatment stage of the plurality of treatment stages corresponds to one of the one or more first 3D dental models of the upper jaw, wherein each tooth measurement of the one or more tooth measurements corresponds to a treatment stage of the plurality of treatment stages; identify a minimum tooth measurement of the one or more tooth measurements ([0127] and [0136]); and identify a first treatment stage of the plurality of treatment stages, wherein the first treatment stage corresponds to the minimum tooth measurement, and wherein the recommended palatal expansion amount is based on the first treatment stage (since the initial position and the proposed final position and applied constraints defined to the processor to generate the sequential stages corresponding to individual palatal expanders [0119]).
Regarding claim 12, Wu discloses that the reference points/control points could be placed in all the teeth [0135]. Also, Wu discloses the expansion axis may be determined for a particular patient based on landmarks from the oral cavity (e.g., using digital model) and/or additional physiological markings from the patient. As illustrated in FIGS. 17A and 17B, the expansion axis may be determined by identifying a jaw basis, where the x axis passes the left and right molars, y is the middle plane of all teeth and z axis is the occlusal plane. The expansion axis may be located at a middle plane (YZ plane of the jaw basis), and may be determined by the anatomy of the bone [0129]. Also, Wu discloses for each stage, the morphable model may be morphed to allow accurate prediction of the palate. The morphable model may be morphed using any appropriate morphing algorithm. The positions of the teeth (e.g., tipping) may be determined as well (e.g., based on tooth crown and/or centers to determine tooth movement. Thus, for each stage, the morphable model may be morphed based on the staging. The processor may include any retention attachments, and may also tag each stage.
Therefore, the Examiner notes that Wu’s system (a generic computer) is capable of being programed to perform the following algorithmic steps (see the 112(b) rejection above): “wherein to determine the one or more tooth measurements, the processing device is further to: determine, for each treatment stage of the plurality of treatment stages, a first distance between a first reference point on a right side of the upper jaw and a second reference point on the right side of the lower jaw, and a second distance between a third reference point on a left side of the upper jaw and a fourth reference point on the left side of the lower jaw, wherein the first reference point represents a midpoint between a first landmark on a first portion of a first 3D dental model representing the upper jaw and a second landmark on the first portion of the first 3D dental model representing the upper jaw, wherein the second reference point represents a second midpoint between a third landmark on a second portion of a second 3D dental model representing the lower jaw and a fourth landmark on the second portion of the second 3D dental model representing the lower jaw, wherein the first portion corresponds to the second portion, wherein the third reference point represents a third midpoint between a fifth landmark on a third portion of the first 3D dental model representing the upper jaw and a sixth landmark on the third portion of the first 3D dental model representing the upper jaw, wherein the fourth reference point represents a fourth midpoint between a seventh landmark on a fourth portion of the second 3D dental model representing the lower jaw and an eighth landmark on the fourth portion of the second 3D dental model representing the lower jaw, wherein the third portion corresponds to the fourth portion”.
Regarding claim 13, Wu discloses wherein the first portion represents an upper-right first molar, wherein the second portion represents a lower-right first molar, wherein the third portion represents an upper-left first molar, and wherein the fourth portion represents a lower-left first molar (since the control points selected may include the crown center and root center of all teeth [0135]).
Regarding claim 14, the Examiner notes that Wu’s system (a generic computer) is capable of being programed to perform the following algorithmic steps or to assign the following parameter to the programed algorithm (see the 112(b) rejection above): wherein the first landmark and the fifth landmark represent a lingual-distal tooth cusp, wherein the second landmark and the sixth landmark represent a lingual-mesial tooth cusp, wherein the third landmark and the seventh landmark represent a buccal-distal tooth cusp, and wherein the fourth landmark and the eighth landmark represent a buccal-mesial tooth cusp.
Regarding claim 17, Wu discloses wherein to provide, to the user device, the recommended palatal expansion amount, the processing device is further to: provide, for display in a user interface (UI) of the user device (see user interface may present the user with a graphic display [0040]), a representation of the one or more 3D dental models, wherein the representation comprises an indicator of a first reference point of the plurality of reference points; and provide, for display in the UI of the user interface, at least one of the recommended palatal expansion amount, a number of expanders to achieve the recommended palatal expansion amount, or at least one of the one or more tooth measurements ([0040]).
Regarding claim 18, Wu discloses wherein the user device corresponds to a patient device, a doctor device, or a scanning device (computer, tablet, smartphone, etc. [0116]).
Regarding claim 19, Wu discloses a method comprising: identifying a plurality of reference points (control points in [0135]) within one or more three-dimensional (3D) dental models of a patient; determining one or more tooth measurements based on the plurality of reference points (since the system comprises manipulation of the model can be constrained obtained the anatomy of jaw and bone, and/or by measurement and data analysis of real treatment outcome [0123] and for instance the distance of movement between molars may be measured [0131]); determining, based on the one or more tooth measurements, a recommended palatal expansion amount for a palatal expansion treatment plan for the patient ([0133]); and providing, to a user device, the recommended palatal expansion amount ([0134] and see user interface may present the user with a graphic display [0040]).
Regarding claim 20, Wu discloses a non-transitory computer-readable storage medium ([0111]) comprising instructions that, when executed by a processing device, cause the processing device to: identify a plurality of reference points (see control points in [0135]) within one or more three-dimensional (3D) dental models of a patient; determine one or more tooth measurements based on the plurality of reference points (since the system comprises manipulation of the model can be constrained obtained the anatomy of jaw and bone, and/or by measurement and data analysis of real treatment outcome [0123] and for instance the distance of movement between molars may be measured [0131]); determine, based on the one or more tooth measurements, a recommended palatal expansion amount for a palatal expansion treatment plan for the patient ([0133]); and provide, to a user device, the recommended palatal expansion amount ([0134] and see user interface may present the user with a graphic display [0040]).
Claim(s) 1, 5 and 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cramer (US 20250186169 A1).
Regarding claim 1, Cramer discloses a memory; and a processing device to execute instructions from the memory ([0056]) to: identify a plurality of reference points within one or more three-dimensional (3D) dental models of a patient ([0072]); determine one or more tooth measurements based on the plurality of reference points (since “Treatment Benchmarks,” may include one or more standards or reference points of at least part of a treatment plan; including intended positions of teeth, jaws, palatal regions, etc. of dentition at a specific stage of a treatment plan or positions of a specific stage of a treatment plan on a 3D model of a patient's dentition [0072]); determine, based on the one or more tooth measurements, a recommended palatal expansion amount for a palatal expansion treatment plan for the patient (since a dental professional may prescribe through the system palatal expanders, to treat dental conditions that are associated with the dental condition and/or progress assessment [0074]); and provide, to a user device, the recommended palatal expansion amount (see GUI in [0276]).
Regarding claim 5, Cramer discloses wherein the processing device is further to: provide the one or more 3D dental models as input to an artificial intelligence (Al) model ([0168]), wherein the Al model provides a plurality of indications, each indication of the plurality indications representing a location of a reference point within one of the one or more 3D dental models (since the system incorporates AI model components to aid with managing aspects of the treatment plan, to process, clean, filter, upscale, downscale, compress, sample, etc., data associated with the treatment plan coordination system [0168]).
Regarding claim 16, Cramer discloses wherein to determine the recommended palatal expansion amount, the processing device is further to: provide, as input to an artificial intelligence (Al) model, the one or more tooth measurements, wherein the Al model provides the recommend palatal expansion amount (since the system incorporates AI model components to aid with managing aspects of the treatment plan, to process, clean, filter, upscale, downscale, compress, sample, etc., data associated with the treatment plan coordination system [0168]).
Claim(s) 1, 11 and 15 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sato (US 20250032219 A1).
Regarding claim 1, Sato discloses a system comprising: a memory; and a processing device to execute instructions from the memory ([0124]) to: identify a plurality of reference points within one or more three-dimensional (3D) dental models of a patient (see control points in [0096]); determine one or more tooth measurements based on the plurality of reference points (since the direction and extent of movement may be limited or modified based on the relative location within the palate of said control points [0096]; therefore the system takes measurements based on the plurality of reference points/control points); determine, based on the one or more tooth measurements, a recommended palatal expansion amount for a palatal expansion treatment plan for the patient ([0096]); and provide, to a user device, the recommended palatal expansion amount (see user interfaces in [0124]).
Regarding claim 11, Sato discloses wherein the one or more 3D dental models comprise one or more first 3D dental models of an upper jaw and a second 3D dental model of a lower jaw ([0070]), and wherein to determine the recommended palatal expansion amount, the processing device is further to: identify a plurality of treatment stages of the palatal expansion treatment plan ([0007] and [0081]), wherein each treatment stage of the plurality of treatment stages corresponds to one of the one or more first 3D dental models of the upper jaw, wherein each tooth measurement of the one or more tooth measurements corresponds to a treatment stage of the plurality of treatment stages (see … and applying constraints on the movements of the palate, teeth and/or gingiva in the jaw, including constraints (e.g., limits) on one or more of: the rate of movement of the two sides of the palate, the rate of expansion as measured between two or more subsets of teeth (e.g., between a first set of molars on a first side and a second set of molars on the contralateral side of the patient's upper jaw [0081]); identify a minimum tooth measurement of the one or more tooth measurements; and identify a first treatment stage of the plurality of treatment stages, wherein the first treatment stage corresponds to the minimum tooth measurement (since a customized palatal expander may be generated for each intermediate position and for the final endpoint [0081]), and wherein the recommended palatal expansion amount is based on the first treatment stage (since after receiving a digital model of the patient’s oral cavity, the digital model may be used to predict both orthopedic (palatal) and orthodontic (dental) movement, and the model may be used to determine a final position setup and to define the movement/velocity of the palatal expansion and/or teeth [0083]).
Regarding claim 15, Sato discloses wherein to determine the one or more tooth measurements, the processing device is further to: for each treatment stage of the plurality of treatment stages and for each side of a right side and a left side (since in general, when modeling the incremental palatal expansion to stage the palatal expansion, the movement of the palate, e.g., the outward expansion of the palate forcing apart the right side of the palate from the left side of the palate, on either side of the suture, which may be offset relative to the midline of the application [0090]): generate a first occlusal plane for a first side of the second 3D dental model of the patient, wherein the first occlusal plane extends from a first buccal cusp of a premolar tooth along a second buccal cusp of a molar tooth; generate a second occlusal plane for the second 3D dental model of the patient, wherein the second occlusal plane extends from a tooth crown center of a first-lower molar of the second 3D dental model along a first direction (since the occlusal plane may be the crown center plane of all of the upper teeth, for example, with the y-axis extending down the midline of the paired crown centers [0093]); generate a ray intersecting the first occlusal plane and the second occlusal plane (see rays shown in Figures 3D-E); identify a first midpoint between a lingual-distal cusp and a lingual-mesial cusp of a first- upper molar of the first 3D dental model and a second midpoint between a buccal-distal cusp and a buccal-mesial cusp of the first-lower molar of the second 3D dental model, wherein the first 3D dental model and the second 3D dental model correspond to the particular treatment stage of the plurality of treatment stages (since in general, when modeling the incremental palatal expansion to stage the palatal expansion, the movement of the palate may be … relative to an xy-plane through the midpoint of the teeth in the upper arch [0092]); project the first midpoint and the second midpoint to the ray (see how the rays passes through the midpoints of the teeth in Figure 3D); and calculate a distance between the first midpoint and the second midpoint projected onto the ray, wherein the one or more tooth measurements comprises the distance between the first midpoint and the second midpoint (since the palatal expansion is calculated through the midpoint of the teeth of the patient's upper jaw, see [0031], [0090] and [0092]; therefore the system must calculate the distance between the first midpoint and the second midpoint).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST).
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/LUIS RUIZ MARTIN/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
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