Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Rejection based on 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 1-7 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 determining patent subject matter eligibility under 35 U.S.C. 101 the U.S. Patent Office issued guidance on January 7, 2019 that was then updated in October 2019. That guidance has since been incorporated into the Ninth Edition, Revision R-01.2024 of the Manual of Patent Examination Procedure (MPEP), particularly Sections 2103 through 2106.07(c). The Step 1, Step 2A Prong One, Step 2A Prong Two, and Step 2B determinations set forth in the Patent Office guidance and MPEP are addressed below.
35 U.S.C. 101 – Step 1 – Determination as to whether claims are directed to a statutory category specified in 35 U.S.C. 101 (MPEP 2106.03) - Claims 1-12 are directed to a “method of adjusting a thickness of a 3D printed oral appliance.” Applicant’s claims are interpreted as a falling with in the “useful process” statutory class of 35 U.S.C. 101.
35 U.S.C. 101 – Step 2A Prong One - Determination as to whether the claims recite a Judicial Exception including an abstract idea, law of nature, or natural phenomenon (MPEP 2106.04). Claims 1-7, as a whole, are directed to the Judicial Exception (MPEP 2106.04) of an abstract idea (MPEP 2106.04(a)). 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 (MPEP 2106.04(a)(2)). More particularly with respect to independent claim 1, the method step of “capturing a three-dimensional electronic representation of a dentition of a subject. . .” may be performed mentally (e.g. an orthodontist mentally receives, or records with paper and pencil, data representing a 3D model of a patient’s dentition); the method step of “setting a bite registration between the upper arch model and the lower arch model” may be performed mentally (e.g. an orthodontist mentally, or with paper and pencil, sets the position/registration between the 3D model of the upper and lower arch models); the method step of “generating an initial shell model based on the upper arch model and the lower arch model” may be performed mentally, or with paper and pencil (e.g. an orthodontist mentally imagines upper and lower shell models that are positioned over the upper and lower arch models); the method step of “simulating a bite between the upper arch model and the lower arch model” may be performed mentally (e.g. an orthodontist mentally imagines a bite between the model of the patient’s upper and lower arch models); the method step of determining overlap regions in the initial shell model when the bite is simulated” may be performed mentally (e.g. an orthodontist mentally determines where the upper and lower shell models overlap during a bite); and the method step of “removing the overlap regions of the initial shell model to form thinned regions” may be performed mentally (e.g. an orthodontist mentally determines a thinning of the upper and lower shell models in the overlapping regions).
In regard to claim 2, the claimed method step of “digitally mounting the upper arch model and the lower arch model on a virtual articulator” may be performed mentally by an orthodontist imaging such a process. In claims 3 and 4, an orthodontist is capable of mentally envisioning additional features in the shell models. In regard to claim 5, the method step of “determining stresses on the initial shell model” is capable of being determined by an orthodontist mentally or with paper and pencil. In regard to claim 6, the method step of “removing isolated islands or peninsular pieces from the initial shell model” may be performed mentally by an orthodontist envisioning the removal for such features from the virtual model.
In regard to claims 8 and 9 (including dependent claims 10-12), the method step of “fabricating the oral appliance/support structure” requires the creation of a tangible physical device and the method is incapable of being performed mentally. Consequently, claims 8-12 are not subject to the judicial exception of an “abstract idea.”
Furthermore, it is noted that applicant’s method claims 1-7 are written in broad terms with no limitations on how the bite registration between the upper and lower arch models is set/determined, how the shell models are generated, how the bite is simulated, or the overlap regions determined; and there are no requirements set forth regarding the accuracy or detail of the determinations. Such a broad, high-level method further supports the mental process determination.
35 U.S.C. 101 – Step 2A Prong Two requires a determination as to whether the claims as a whole integrates the Judicial Exception into a Practical Application of that exception (MPEP 2106.04(d)). The limitations of claim 1 requiring the “setting a biter registration between the upper arch model and the lower arch model via a processor” and “generating an initial shell model based on the upper arch model and the lower arch model via the processor” amounts to an “additional element” beyond the abstract idea, however, the performance of a mental process on a generic computer/computer readable medium fails to integrate the Judicial Exception into a Practical Application of the exception (see MPEP 2106.04(a)(2)(III)(C)). There is no disclosure that the method steps/computer instructions improve the manner in which the processor operates (see MPEP 2106.04(d)(1)). The claims do not go beyond generally linking the judicial exception to a computer environment. The claims do not require that the method be implemented by a particular machine (see MPEP 2106.05(b)), nor do the claims require the method to particularly transform a particular article (see MPEP2106.05(c)). The claims as whole fail to integrate the abstract idea (the “judicial exception”) into a practical application of that abstract idea.
Claims 1-7 are directed solely to a digital virtual environment where data is input (“capturing”) and processed (“setting”; “generating”; “simulating”; “determining”; “removing”) – there are no additional elements integrating the judicial exception into a practical solution – the computer method is not used to operate a manufacturing device, the computer method is not used to improve the functioning of a computer, the computer method is not used to transform a particular article into a different state or thing – there is no meaningful limitation beyond generally linking the use of the judicial exception to a particular technological environment.
Additionally, it is noted that orthodontists have long practiced their trade/art of moving and repositioning teeth into alignment – well before the advent of computer use in the medical and dental fields – and are most certainly capable of viewing a patient’s dentition, determining the bite registration between the patient’s upper and lower teeth; envisioning shell models for the patient’s upper and lower teeth, where those shell models would overlap in a bite, and then the thinning of those shell models in the overlapping regions . . . all without the use of a computer.
35 U.S.C. 101 – Step 2B requires a determination as to whether the claims amount to Significantly More than the Judicial Exception (MPEP 2106.05). As set forth above with respect to Step 2A Pong One the claimed computer method steps on the “processor” of claims 1-7 are all capable of being performed mentally and represent nothing more than concepts related to performing observations, evaluations and judgements which fall within the judicial exception. The “processor” requires a most a generic general-purpose computer. There is no disclosure in the written description that the processor device is anything more than a generic component, nor is there any disclosure that the method improves the manner in which the processor device operates. The mere recitation in the claims of a generic conventional computer that is intended to be 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 inputting and processing data with a standard generic computer.
Additionally, with respect to claim 7, the “exporting” data step amounts to insignificant post solution activity and does qualify as “significantly more” when recited in a claim with a judicial exception – see MPEP 2106.05(I)(A).
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 presenting 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.
Allowable Subject Matter
Claims 8-12 are objected to as being dependent on a rejected base claim, but would be allowable if rewritten in independent form to include all of the limitations of the claims from which they depend.
The closest apparent prior art of record is Boronkay (US 2017/0007363) who discloses a method using a computer processor to design orthodontic oral appliances and produce them in a 3D printing process (e.g. paragraph [0317]). In Boronkay, a 3D representation of the patient’s teeth is acquired (Fig 39, step 3910), a shell appliance model is determined (Fig 38, step 3830), and instructions generated for fabricating the appliance (3840). Boronkay further discloses that the thickness of the appliance occlusal areas may be varied and thinned in order to close an open bite, adjust for an overbite or address other bite issues (note particularly paragraphs [0127]-[0128]), but does not appear to disclose how such a reduced thickness is determined in the computer design of the appliance(s). One of ordinary skill in the art at the time of applicant’s invention would have arguably found it obvious to have used some general computer simulation of the patient’s bite to make such determinations, however, there is no reasonable teaching or suggestion of using such a computer simulation for “determining overlap regions in the in the initial shell model” and then “removing the overlap regions from the initial shell model to form thinned regions having a thickness less than the predetermined thickness to form a final shell model” as the particularly claimed by applicant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712