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.
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 1-19 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. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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 10.2019 (revised June 2020) 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 1-11 are directed to “[a] computer-implemented method of designing a dental restoration” that uses “a computing device” for “receiving . . . a digital impression”, “generating a digital model”, “receiving . . . instructions”, “receiving . . . a restoration prescription”, “receiving . . . motion data”, “receiving instructions . . . instructing the first program module to generate interference model data”, “receiving instructions . . . instructing a second program module to generate restoration data” and “designing the dental restoration.” The “method” is within the 35 U.S.C. 101 statutory category of a “process” (MPEP 2106.03).
In regard to claims 12-19, the claimed invention is directed to "[a] system for designing a dental restoration . . . comprising: at least one processing device; a design system; and at least one memory device comprising computer readable instructions that . . . perform operations comprising: receiving a digital dental impression . . . ; receiving instructions . . .; receiving motion data . . .; extracting an interference surface . . . ; receiving instructions . . . ; receiving a restoration prescription; receiving instructions . . .; and calculating a distance . . .” The claimed “system” is within the 35 U.S.C. 101 statutory category of a “machine” (MPEP 2106.03) because it claims physical elements including a processing device and memory.
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 1-19 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 judgments (MPEP 2106.04(a)(2)(III).
More particularly, with respect to claim 1, the steps of “receiving” data (i.e. digital impression data, instructions to generate a digital model, a restoration prescription, motion data, instructions to generate interference model data) may all be done mentally (e.g. a dentist views the data and instructions including images and stores the data in his/her mind or on paper via paper and pencil). The steps including instructions to generate interference model data and dental restoration data may be performed mentally (or on paper with pencil) (e.g. a dentist generates interference model data and restoration data based on the data received by visual observances and/or numerical calculations). The step of generating a movement path and interference model data by sweeping the digital model data along a movement path may be done mentally (the orthodontist envisions the movement and determines where teeth may interfere with one another or make such determinations via paper and pencil (e.g. the dentist calculates/determines where the digital model data interferes along the path described by the motion data)). And finally, the step of designing the dental restoration based on the data and determinations may again be done mentally (the dentist envisions a design for the restoration or draws a design for the restoration via paper and pencil based on the data received and the interpretation of the data).
In regard to claim 2, the practitioner is capable of mentally receiving data in different formats. In claim 3, the practitioner is capable of mentally envisioning 3D models. In regard to claims 4 and 5, the practitioner is capable of receiving data on the patient’s arches and movement thereof. In claim 6, the practitioner is capable of mentally determining a movement path based on received motion data. In claims 7 and 10, a practitioner is capable of mentally creating an interference model based on the locations of a patient’s upper and lower jaw and movement of the lower jaw with respect to the upper jaw. In claims 8, 9 and 11, a practitioner is capable of mentally determining restoration data based on the received data.
In claim 12, the memory device instructions to perform receiving data and instructions (i.e. receiving digital impression, receive instructions to generate a digital model, receive motion data, receive instructions to generate an interference model, receive a prescription, receive instructions to generate restoration data) and then to calculate a distance may all be done mentally (e.g. a dentist views the data and instructions including images and stores the data in his/her mind or on paper via paper and pencil). The steps including instructions to generate interference model data and dental restoration data may be performed mentally (or on paper with pencil) (e.g. a dentist generates interference model data and restoration data based on the data received by visual observances and/or numerical calculations).
In regard to claims 13 and 14, the source of the data used by the system for designing a dental restoration doesn’t place any meaningful limitations on the system itself. In claim 15, the practitioner is capable of mentally determining a movement path based on received motion data. In claim 17, the practitioner is mentally capable of assigning colors based on calculated distances. In claims 18 and 19, a practitioner is capable of mentally determining restoration data based on the received data. The dependent claims fail to add any additional steps beyond those of parent claim 12 that could not be performed mentally.
It is noted that dentists have long practiced their trade/art of designing/determining the shape of dental restorations based on the shape of a patient’s dentition (impression) and how particular teeth relate to opposing teeth during motion (e.g. chewing)– well before the advent of computers – and are most certainly capable of envisioning and mentally determining the shapes and arrangements dental restorations that have minimal interference with the dentition in the opposing arch.
Moreover, it is noted that the claimed method and computer operation are set forth in the claims with a high level of generality. For example, there are no constraints on the accuracy of the dental models or motion data; the accuracy and level of detail for the movement path or interference model generations, or specifically how interference determinations are digitally manipulated to design the dental restoration. The broad high level claims cover detailed highly defined dental restoration designs, as well as, roughly estimated dental restoration designs. Such broad high levels of generality further support 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)).
Method claim 1 requires the receiving of data (“digital impression”, “restoration prescription“ and “motion data”) and the receiving of instructions (to “generate a digital model”, to “generate interference model data”, “to generate dental restoration data”) at a “computing device” and at “a user interface” and appears to implicitly require the use of the “computing device” to perform the “generating” of the dentition digital model, movement path, and interference model data, as well as, the “designing the dental restoration” method steps. The inclusion of the “computing device” and “user interface” amounts to an “additional element” beyond the “abstract idea”, however, there is no disclosure that the method steps/computer instructions improve the manner in which the processing device 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.
Additionally, to the extent that one would determine the “receiving” data steps as something beyond a “mental process,” then such steps are interpreted as “insignificant extra-solution activity” (see MPEP 2106.05(g)(3)) and are insufficient as an “additional element” to integrate the judicial exception into a practical application. The claim is directed solely to a digital virtual environment where data is input (“receiving”) and then processed (“generating”, “generating”, “generating”, and “designing”) – there are no additional elements integrating the judicial exception into a practical solution – the determinations are not used to operate a manufacturing device, the determinations are not used to improve the functioning of a computer, the determinations are 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. Dependent claims 2-11 do not require any “additional elements” beyond the abstract idea of a mental process other than the “computing device” and “user interface” addressed with respect to claim 1.
Claim 12 is directed to a “system” that includes “at least one processing device”, a “design system” and “at least one memory device”. There is no disclosure that the “processing device”, the “design system” and/or “memory device” are anything other than generic computer components. The inclusion of the “processing device” and “memory device” amounts to an “additional element” beyond the abstract idea, however, there is no disclosure that the “computer readable instructions” improve the manner in which the processing device/memory device 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 computer readable instructions be implemented by a particular machine (see MPEP 2106.05(b)), nor do the claims require the system 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. Dependent claims 13-19 do not require any “additional elements” beyond the abstract idea of a mental process other than the “processing device” and “memory device” addressed with respect to claim 16.
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 steps/instructions are all capable of being performed mentally and represent nothing more than concepts related to performing observations, evaluations and judgments which fall within the judicial exception. The “computing device” and “user interface” of claim 1 and the “processing device” and “memory device” of claim 12 require at most nothing more than a general-purpose computer processor/memory. There is no disclosure in the written description that the computing device, user interface, processing device or memory device are anything more than generic computer components, nor is there any disclosure that the claimed method/computer instructions improve the manner in which the generic computer components operate. The mere recitation in the claims of a generic conventional computer 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 inputting (“receiving”) and processing data (“generating”, “designing”, “calculating”, “assigning”) 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 data according to an algorithm. The claimed method and system 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.
Response to Applicant’s Remarks
Initially applicant references a Patent Office Memorandum dated August 4, 2025 directed to “Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101” and asserts that the claimed invention includes subject matter eligibility because the claimed method and system (i) cannot be practically performed in the human mind (step 2A, prong one) and (ii) integrates the claimed invention into a practical application (step 2A, prong 2) that improves the technical field of restoration design. The examiner is not persuaded.
In regard to the step 2A, prong one analysis, the claimed method and computer operation are set forth in the claims with a high level of generality. For example, there are no constraints on the accuracy of the dental models or motion data; the accuracy and level of detail for the movement path or interference model generations, or specifically how interference determinations are digitally manipulated to design the dental restoration. The data being processed could consist anywhere from a few data points to millions of data points. The broad high level claims cover detailed highly defined dental restoration designs, as well as, roughly estimated dental restoration designs. Such general calculations and determinations are reasonably capable of being performed in the human mind, with or with the aid of pencil and paper. The broad high levels of generality further support the mental process determination.
In regard to the step 2A prong two analysis, as noted in the rejection the claims do not require that the method be implemented by a particular machine, the do not improve the functioning the claimed processing device 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 data according to an algorithm. In reference to the ”apply it” consideration, the claims fail to recite significant details of how a solution to a problem is accomplished and merely invokes computer machinery as a tool to perform conventional computations.
Double Patenting
The double patenting rejections set forth in the Office Action of June 11, 2025 are withdrawn in view of the terminal disclaimer filed December 11, 2025.
Action Made Final
THIS ACTION IS MADE FINAL. 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.
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