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 .
Claim Status
Claims 21-49 are canceled.
Claims 1-20 are pending and under examination herein.
Claims 1-20 are rejected.
Priority
The instant application claims priority to US Provisional Application 63/313145, filed 02/23/2022. As such, the effective filing date assigned to each of claims 1-20 is 02/23/2022
Information Disclosure Statement
The Information Disclosure Statements filed 04/18/2023, 10/26,2023 And 09/30/2025 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The drawings filed 02/10/2023 are accepted by the examiner.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claims 1, 8 and 15 recite generating an output state of the patient based on the initial state of the patient and the plurality of treatment parameters; calculating an objective function based on the output state of the patient and the treatment goal of the patient; and updating one or more of the treatment parameters based on the objective function.
These recitations equate to steps of collecting information, analyzing data and making observations, evaluations and judgements that can be carried out in the human mind. Specifically, generating an output state of the patient based on the initial state of the patient and treatment parameters, calculating an objective function based on the output state and the treatment goal of the patient, and updating one or more of the treatment parameters based on the objective function can be practically performing the human mind as claimed, since the mind can read data and make mathematical estimations/comparisons as claimed and are similar to the concepts of collecting and comparing known information in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011) and collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) that the courts have identified as concepts that can be practically performed in the human mind. Therefore, each of the above recited limitations fall under the “Mental Processes” grouping of abstract ideas. Furthermore, the steps of calculating an objective function based on the output state and the treatment goal of the patient, and updating one or more of the treatment parameters based on the objective function equate to organizing information and manipulating information through mathematical correlations and reciting a mathematical equation, similar to the concepts of taking existing information, manipulating the data using mathematical functions, and organizing this information into a new form in Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014). Therefore, these limitations fall under the “mathematical concepts” grouping of abstract ideas. Claims 2-6, 7, 9-12, 14 and 16-20 further qualify the judicial exceptions. As such, claims 1-20 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology, applies or uses the recited judicial exception to affect a particular treatment for a condition, implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, effects a transformation or reduction of a particular article to a different state or thing or applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Rather, the instant claims recite additional elements that amount to mere data gathering and mere instructions to implement the abstract idea in a generic computing environment. Specifically, the claims recite the following additional elements:
Claims 1, 8 and 15 recites receiving patient data, wherein the patient data comprises information representing an initial state of a patient; receiving a plurality of treatment parameters, wherein the plurality of treatment parameters are based on a treatment goal for the patient.
Claim 1 also recites computer-implemented.
Claim 8 also recites at least one memory; and at least one processor
Claim 15 also recites non-transitory computer-readable storage medium comprising at least one instruction.
Claims 6, 13 and 20 recite wherein the patient data comprises an inter-oral scan.
Claims 7 and 14 recite wherein the treatment goal for the patient comprises a three-dimensional (3D) mesh.
Claims 1, 8 and 15 recites limitations of receiving data and claims 6-7, 13-14 and 20 recites further limitations on the type of data that is received. These limitations equate to mere data gathering activity to obtain the data necessary for the mental evaluations and judgements (see MPEP 2106.05(g)). Claims 1, 8 and 15 also merely recites using a generic computing systems and computer program products to carry out instructions to implement an abstract idea on a computer. The computer system and computer program product as claimed fails to recite details of how a solution to a problem is accomplished and only recites the idea of a solution or outcome. There are no limitations that indicate that the claimed steps require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. Furthermore, the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). There is no indication that any of these additional elements provide a practical application of the recited judicial exception outside of the judicial exception itself. As such, claims 1-20 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). Further analyzing the additional elements under step 2B, the additional elements as described above do not rise to the level of significantly more than the judicial exception. As set forth in the MPEP, determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims under the 2B analysis, the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Therefore, the additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception, and the claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-20 are not patent eligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-8, 10-15 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (US20210259808A1; hereafter referred to as Nguyen).
With respect to claims 1, 8 and 15, Nguyen discloses a computer-implemented automated method for generating one or more final setups for orthodontic treatment of an embodiment of the invention includes receiving a digital 3D model of teeth in an initial state (abstract; para 0002; para 0012-0015).
Nguyen discloses receiving one or more setups representing a proposed state of teeth in a digital 3D model of teeth after a particular stage of orthodontic treatment (i.e. treatment parameters based on a treatment goal) (para 0013-0023; claim 26; claim 35).
Nguyen discloses generating an output based on the inputs, which include positions, orientations, and IPR quantities for the teeth in the arch form coordinate system that represent one or more Final Setup States (para 0024; claim 12; para 0053).
Nguyen discloses the method generates metrics for use in the scoring function to generate a final setup and can rate final setups, and that the at the core of the algorithm is a scoring function or an objective function(para 0028). Nguyen further discloses that by repeatedly updating the state through selecting scoring functions, perturbing, and selecting states that decrease the value of the scoring function, an improved final state can be generated, indicating that the objective function is calculated based on a output state and the treatment goal, and that metrics are updated (para 0004; para 0032-para 0038; fig 1-2).
With respect to claims 3-4, 10-11, and 17-19, Nguyen’s methods include simulating the movement of the teeth perturbing a state of the teeth through movement of a tooth or set of teeth within the digital 3D model of teeth to generate a perturbed state of the teeth, and that the scoring function can be in a probabilistic framework such as machine learning classifiers (claim 1; abstract; para 0013-0031). Nguyen discloses the perturb state is a set of functions that allow physical transformations in 3D which comprise translations and rotations of an individual tooth or a set of teeth and IPR (i.e. numerical, bio-mechanical model), and further that many perturbations can be applied and evaluated, with the optimal one, as chosen by optimizing a score or via an iterative optimization algorithm such as gradient descent being selected (para 0035).
With respect to claims 5, 7, 12, 14, and 20, Nguyen discloses output of the final setup algorithm includes positions, orientations, and IPR quantities for the teeth in the arch form coordinate system that represent one or more Final Setup States, and further discloses systems can receive and process intra-oral scans, and generate digital 3D images or models based upon image sets from multiple views (para 0012; fig 1)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US20210259808A1; hereafter referred to as Nguyen) as applied to claims 1, 8 and 15 above, and further in view of Abraham et al. (US20200175678A1; hereafter referred to as Abraham) as evidenced by Kingma and Ba (arXiv preprint arXiv:1412.6980. 2017 Jan 30; hereafter referred to as Kingma).
With respect to claims 2, 9, and 16, Nguyen discloses the steps of claims 1, 8 and 15, as applied above.
However, while Nguyen discloses machine learning can be used to derive a combination of the metrics that differentiate final setups from malocclusions and other non-ideal arrangements of teeth and neural network autoencoders can be used, and that optimal perturbation states can be chosen by optimizing a score or via an iterative optimization algorithm such as gradient descent, Nguyen does not appear to disclose identify the one or more treatment parameters based on a derivative of the objective function (para 0035-0038; para 0054; para 0060).
However, with respect to claims 2, 9, and 16, the prior art to Abraham, in the same field of endeavor, discloses using neural networks for automated segmentation of anatomical features of a 3D image for the purpose of treatment planning and follow-up, in which each neural network model has an objective function (also referred as a “loss function”) chosen at the model design step and that each model is trained in a fully supervised setup, meaning that for each data sample in the training data set there is a known correct value that the model should predict, referred to as “ground truth” values, and further discloses the training methods includes updating the model's weights using one of the gradient descent methods such as an Adam optimizer and repeating the steps over and over with different input samples until one of the following conditions is met: a target accuracy (difference between predicted and ground truth) is reached, or the difference between predicted and ground truth values is not decreasing or decreasing very slowly as the training proceeds, indicating the a treatment parameter is identified (abstract; para 0007-0009; para 0283-0292). Kingma discloses the computation of first-order partial derivatives when calculating the gradient in the Adam optimizer (p 1, para 1-p 3, para 5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the machine learning of Nguyen with the neural network with the Adam optimizer of Abraham, because it would aid in the automated segmentation of anatomical features of a 3D image for the purpose of treatment planning and follow-up, as disclosed by Abraham. There would be a reasonable expectation of success because using the neural network of Abraham for segmentation of the input would not hinder the analysis methods of Nguyen, since Nguyen also uses iterative optimization algorithm such as gradient descent. Therefore, the invention is prima facie obvious.
Conclusion
No claims allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI DHARITHREESAN whose telephone number is (571)272-5486. The examiner can normally be reached Monday - Friday 9:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D Riggs II can be reached at (571) 270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.D./Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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