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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
Claims 38 and 54 recite a “rule-based prediction model”. The provisional application discloses a prediction model based on a decision tree model, but a rule-based prediction model is not explicitly defined (see Paragraph [0017]).
Claims 44-45 recite, “clinical factors comprise one or prescribed settings”. While spacing factors and clinical factors are used interchangeably in the amended claims, the specification of the provisional application does not support the use of these terms interchangeably. Spacing factors are disclosed as including prescribed settings, but clinical factors are not disclosed as including prescribed settings (see Paragraphs [0012], [0035], [0121]).
For the purpose of examination, the priority date for claims 38-59 is 02/20/2024.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claims 38 and 54 recite a “rule-based prediction model”. The specification discloses a prediction model based on a decision tree model, but a rule-based prediction model is not explicitly defined (see Paragraph [0017]).
The amendment filed 03/02/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
Claims 44-45 recite, “clinical factors comprise one or prescribed settings”. While spacing factors and clinical factors are used interchangeably in the amended claims, the specification does not support the use of these terms interchangeably. Spacing factors are disclosed as including prescribed settings, but clinical factors are not disclosed as including prescribed settings (see Paragraphs [0012], [0035], [0121]).
Applicant is required to cancel the new matter in the reply to this Office Action.
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 38-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 – Determination as to whether the claims are directed to a statutory category as specified in 35 U.S.C. 101 (MPEP 2106.03)
The claim(s) recite(s) a method for determining whether or not to modify tooth spacing (claims 38-53) and system for executing this method (claims 54-58).
Step 2A Prong 1 – Determination as to whether the claims recite a Judicial Exception including an abstract idea, law of nature, or natural phenomenon (MPEP 2106.04)
Regarding claims 38-39, 42-53, the steps of “determining… one or more clinical factors”, “applying…a rule-based prediction model” based on the clinical factors, and “providing a recommendation of the one or more interproximal adjustment procedures” are abstract ideas, mental processes and mathematical calculations capable of being performed in the human mind. Orthodontists have long used their own expertise to determine whether interproximal space procedures need to be performed to make room for teeth to move during orthodontic treatment or as preparation for restorative treatments and provided those recommendations to their patients. Applying the mental process a using a rule based prediction model is merely using mathematical calculations/algorithms, as rule-based prediction models at their core are a series of if-then statements.
Regarding claims 40-41, the steps of using a prediction decision tree are also abstract ideas, mathematical algorithms/calculations associated with steps capable of being performed in the human mind.
Regarding claims 54-58, the system comprising a processor, memory, scanner and display is a generic means of performing the steps of “determining… one or more clinical factors”, “applying…a rule-based prediction model” based on the clinical factors, and “providing a recommendation of the one or more interproximal adjustment procedures”. These are abstract ideas, mental processes and mathematical calculations capable of being performed in the human mind .
Examiner recommends Applicant incorporate the language of new claim 59 into the independent claims 38 and 54 to overcome the current 35 U.S.C. 101 rejection, as claim 59 recites a practical application step.
Step 2A, Prong Two – Determination as to whether the claims as a whole integrate the judicial exception into a practical application
This judicial exception is not integrated into a practical application because:
Regarding claims 38-58, the claimed invention does not recite additional elements that integrate the judicial exception into practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea(s) to a particular technological environment or field of use (MPEP 2106.04(d)). Using a computing system with a memory, processor (s), and a scanner to obtain the patient data and process this data is insignificant extra solution activity and does not amount to an inventive concept, particularly when the activity is well-understood and conventional. For at least these reasons and as claims 38-58 do not recite additional elements which integrate the judicial exception into a practical application, the abstract mental processes and mathematical concepts identified for claims 38-58 are not integrated into a practical application.
Step 2B – Determination as to whether the claims amount to significantly more than the judicial exception (MPEP 2106.05)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
Regarding claims 38-58, as set forth above with respect to Step 2A Prong One, the claimed method steps 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 claimed steps of “determining… one or more clinical factors”, “applying…a rule-based prediction model” based on the clinical factors, and “providing a recommendation of the one or more interproximal adjustment procedures” require nothing more than a generic computer processor. The disclosure does not describe additional features to suggest these devices are beyond a generic component for the apparatus. Additionally, the design method is not disclosed as improving the manner in which the apparatus operates. Mere recitation of generic conventional processing 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 data (receiving, dividing) and processing data ( determining, recommending, performing) with a standard computer.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. The claims set forth do not require that the method be implemented by a particular machine and they do not require that the method particularly transforms a particular article. When viewed as a combination, the identified additional elements set forth a process of analyzing information of specific content and are not directed to any particularly asserted inventive technology for performing these functions. The disclosure and claims do not require anything beyond a generic computer to obtain and analyze the data according to mathematical algorithms. Therefore, the claimed method and apparatus fall within the judicial exception to patent eligible subject matter of an abstract idea without significantly more.
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) 38-56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chekhonin et al. (US 20200306011 A1), herein referred to as Chekhonin.
Regarding claim 38, Chekhonin discloses a method (Figs. 3, 57) comprising:
receiving a three-dimensional (3D) digital model of a patient's teeth (303; refer to Paragraphs [0238], [0391], Fig. 44; a 3D model from a direct scan of the patient's teeth is obtained), wherein the 3D digital model includes three-dimensional (3D) representations of teeth on an upper jaw and a lower jaw of the patient (refer to Paragraph [0236]; the digital model is of both the upper and lower arch);
dividing the upper jaw into a plurality of first segments, wherein each of the plurality of first segments has a plurality of first teeth and the lower jaw into a plurality of second segments, wherein each of the plurality of second segments has a plurality of second teeth (305; refer to Paragraphs [0238], [0315]; the digital model for both the upper and lower jaws is segmented into individual teeth or groups of teeth where the upper jaw represents a plurality of first teeth and the lower jaw represents a plurality of second teeth);
determining, for each of the plurality of first segments and the plurality of second segments, one or more clinical factors associated with a digital dental treatment plan of the patient's teeth with the 3D digital model (refer to Paragraphs [0399], [0403], [0410]; parameters are identified based on the digital scan of the patient’s initial teeth position and user prescription instructions/preferences to determine treatment settings that form the treatment targets to generate multiple treatment plans)
applying, for each of the plurality of first segments and the plurality of second segments, a rule-based prediction model that determines, based on the one or more clinical factors, whether an interproximal adjustment procedure comprising interproximal reduction or interproximal spacing would be beneficial (refer to Paragraphs [0053], [0402], [0406], Fig. 56; Examiner understands “a rule-based prediction model” as a decision based prediction model in light of Applicant’s specification (refer to Paragraph [0017]); the treatment settings agent acts as a rule based prediction model in determining the likeliness (prediction) of applying a certain setting using a decision tree; one such treatment setting that is determined is interproximal reduction (IPR); IPR is shown in Fig. 53 as only being applied if crossbite is diagnosed; thus, the treatment settings agent determines IPR should be applied or is beneficial based on the previously determined clinical factor (crossbite); IPR is also described as only being applied when the user treatment preferences indicate IPR as allowable, equivalent to the user determining IPR is beneficial and should thus be allowed in the treatment plan)
providing a recommendation of [[the]] one or more interproximal adjustment procedures as part of [[a]] the digital dental treatment plan of the patient's teeth with the 3D digital model (refer to Paragraphs [0047], [0260], [0412], Figs. 10A-10B; based on the determined treatment settings, the method generates a plurality of treatment plans; one or more of the treatment plans are then displayed with a 3D model of the patient’s teeth indicating that the treatment plan was created with the determined IPR).
Regarding claim 39, Chekhonin discloses the method of claim 38 (Figs. 3, 57), wherein applying the rule-based prediction model comprises determining whether an interproximal adjustment procedure is allowed or not on the plurality of first segments or the plurality of second segments (refer to Paragraphs [0053], [0400], Fig. 54; a treatment setting is any option of an automatic treatment plan that influences the position of teeth such as allowing or restricting IPR).
Regarding claims 40-41, Chekhonin discloses the method of claim 38 (Figs. 3, 57), wherein applying the rule-based prediction model comprises using one or more prediction trees (Fig. 56) comprising [[e]] a plurality of decision nodes (nodes of 5603, 5605) representing clinical criteria for determining whether an interproximal adjustment procedure is recommended on the plurality of first or second segments (refer to Paragraph [0407], annotated Fig. 56 below; multiple decision nodes (nodes of 5603, 5605) are shown based on the initial tooth position; Fig. 56 shows each node representing a criteria, correcting molar class or posterior crossbite, for determination if anterior IPR is required); and
the one or more prediction trees comprise one or more of: a posterior interproximal reduction (IPR) prediction tree, a canine class prediction tree, a mixed canine class decision tree, and an anterior IPR spacing prediction tree (refer to Paragraph [0406], annotated Fig. 56 below; the treatment settings agent predicts whether posterior IPR and anterior IPR are applied).
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Regarding claims 42-43, Chekhonin discloses the method of claim 38 (Figs. 3, 57), wherein the one or more clinical factors comprise one or more clinical setup characteristics for the patient's teeth (refer to Paragraph [0403]; the clinical factors include a variety of characteristics used to determine the treatment settings);
the one or more clinical setup characteristics comprise one or more of:
a presence of missing teeth, a presence of primary teeth, a degree of overjet, a bite classification of the teeth, and a degree of Bolton excess of the teeth (refer to Paragraph [0403]; overbite, crossbite, overjet, crowding and Bolton analysis are identified parameters of a patient's initial teeth position)
Regarding claims 44-45, Chekhonin discloses the method of claim 38 (Figs. 3, 57), wherein the one or more clinical factors comprise one or more prescribed settings for the patient's teeth (5701; refer to Paragraph [0410]; user prescription prescription/instructions are received as part of the method (5700)).
the one or more prescribed settings comprise one or more of: settings to manage an interproximal reduction (IPR) procedure on the plurality of first segments or the plurality of second segments, settings to manage spaces on the plurality of first segments or the plurality of second segments, a bite class goal for the patient's teeth, and an overjet goal for the patient's teeth (refer to Paragraphs [0030], [0041], [0044]-[0045], [0072]; the dental professional may provide input as to if and when and/or where IPR should be used, adjusting for tooth overjet, and an indicator of tooth class correction amount, where tooth class correction is equivalent to correction of a misaligned bite).
Regarding claim 46, Chekhonin discloses the method of claim 38 (Figs. 3, 57), wherein:
the plurality of first segments comprise one or more of:
a first posterior segment with a plurality of upper posterior teeth, and a plurality of first anterior segments, each with a plurality of upper anterior teeth;
the plurality of second segments comprise one or more of: a second posterior segment with a plurality of lower posterior teeth, and a plurality of second anterior segments, each with a plurality of lower anterior teeth;
or some combination thereof (refer to Paragraphs [0315], [0403]; the patient's teeth are segmented into regions for each jaw and each segment, left, anterior, right).
Regarding claim 47, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising incorporating the recommendation of the one or more interproximal adjustment procedures into a final position determination in [[a]] the digital dental treatment plan (refer to Paragraph [0211]; the target arrangement can include a treatment scenario where IPR is appropriate).
Regarding claim 48, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising using the recommendation of the one or more interproximal adjustment procedures to recommend a stage of a digital treatment plan to perform the one or more interproximal adjustment procedures (refer to Paragraph [0011]; the treatment plan indicates the stage to perform interproximal reduction and/or tooth extraction).
Regarding claim 49, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising displaying the recommendation of the one or more interproximal adjustment procedures on a computer- implemented display (refer to Paragraph [0260], Figs. 10A-10B; a display screen shows the teeth at each stage of the treatment plan, where the treatment plan includes IPR).
Regarding claims 50-51, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising displaying the recommendation of the one or more interproximal adjustment procedures on a representation of the 3D digital model of the patient's teeth (refer to Paragraph [0260], Figs. 10A-10B; a display of the teeth at each stage of the treatment plan is shown, where the treatment plan includes IPR and displays the interproximal spacing on a 3D model of the patient's teeth); and
processing one or more user interactions related to the one or more interproximal adjustment procedures with the representation of the 3D digital model of the patient's teeth (refer to Paragraph [0261], Fig. 10B; the treatment plan can be modified to adjust interproximal spacing (1021) on the modeled teeth).
Regarding claim 52, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising:
taking an intraoral scan of the patient's teeth (303; refer to Paragraph [0314]; a digital scan of the patient's teeth from an intraoral scan is obtained);
converting the intraoral scan into the 3D digital model (305; refer to Paragraphs [0238], [0391], Fig. 44; the scan of the patient's teeth is digitized to a 3D model).
Regarding claim 53, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising exporting [[a]] the digital treatment plan comprising the recommendation of the one or more interproximal adjustment procedures for design of aligners to implement [[a]] the digital treatment plan (315; refer to Paragraph [0239]; the treatment plans are submitted to the user via an interface).
Regarding claim 54, Chekhonin discloses a system (refer to Paragraph [0115]) comprising:
one or more processors (refer to Paragraph [0115]);
memory coupled to the one or more processors storing computer-program instructions that, when executed by the one or more processors, cause the system to perform (refer to Paragraph [0115]):
receiving a three-dimensional (3D) digital model of a patient's teeth (303; refer to Paragraphs [0238], [0391], Fig. 44; a 3D model from a direct scan of the patient's teeth is obtained), wherein the 3D digital model includes three-dimensional (3D) representations of teeth on an upper jaw and a lower jaw of the patient (refer to Paragraph [0236]; the digital model is of both the upper and lower arch);
dividing the upper jaw into a plurality of first segments, wherein each of the plurality of first segments has a plurality of first teeth and the lower jaw into a plurality of second segments, wherein each of the plurality of second segments has a plurality of second teeth (305; refer to Paragraphs [0238], [0315]; the digital model for both the upper and lower jaws is segmented into individual teeth or groups of teeth where the upper jaw represents a plurality of first teeth and the lower jaw represents a plurality of second teeth);
determine, for each of the plurality of first segments and the plurality of second segments, one or more clinical factors associated with a digital dental treatment plan of the patient's teeth with the 3D digital model (refer to Paragraphs [0399], [0403], [0410]; parameters are identified based on the digital scan of the patient’s initial teeth position and user prescription instructions/preferences to determine treatment settings that form the treatment targets to generate multiple treatment plans)
applying, for each of the plurality of first segments and the plurality of second segments, a rule-based prediction model that determines, based on the one or more clinical factors, whether an interproximal adjustment procedure comprising interproximal reduction or interproximal spacing would be beneficial (refer to Paragraphs [0053], [0402], [0406], Fig. 56; Examiner understands “a rule-based prediction model” as a decision based prediction model in light of Applicant’s specification (refer to Paragraph [0017]); the treatment settings agent acts as a rule based prediction model in determining the likeliness (prediction) of applying a certain setting using a decision tree; one such treatment setting that is determined is interproximal reduction (IPR); IPR is shown in Fig. 53 as only being applied if crossbite is diagnosed; thus, the treatment settings agent determines IPR should be applied or is beneficial based on the previously determined clinical factor (crossbite); IPR is also described as only being applied when the user treatment preferences indicate IPR as allowable, equivalent to the user determining IPR is beneficial and should thus be allowed in the treatment plan)
providing a recommendation of [[the]] one or more interproximal adjustment procedures as part of [[a]] the digital dental treatment plan of the patient's teeth with the 3D digital model (refer to Paragraphs [0047], [0260], [0412], Figs. 10A-10B; based on the determined treatment settings, the method generates a plurality of treatment plans; one or more of the treatment plans are then displayed with a 3D model of the patient’s teeth indicating that the treatment plan was created with the determined IPR).
Regarding claims 55-56, Chekhonin discloses the system of claim 54 (refer to Paragraph [0115]), further comprising a display coupled to the one or more processors and operative to display the recommendation of the one or more interproximal adjustment procedures on a representation of the 3D digital model of the patient's teeth (refer to Paragraphs [0131], [0260], Figs. 10A-10B; a display of the teeth at each stage of the treatment plan is shown, where the treatment plan includes IPR and displays the interproximal spacing on a 3D model of the patient's teeth).
(New) Regarding claim 59, Chekhonin discloses the method of claim 38 (Figs. 3, 57), further comprising:
modifying the digital dental treatment plan of the patient's teeth based on the recommendation (refer to Paragraphs [0029], [0033]; the user may modify any of the plans based on the precalculated treatment plans that include a recommendation with or without IPR and/or extractions)and
forming one or more orthodontic appliances according to one or more stages of the digital dental treatment plan of the patient's teeth (325; refer to Paragraph [0240]; the series of aligners from the treatment plan are manufactured).
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) 57-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chekhonin et al. (US 20200306011 A1), herein referred to as Chekhonin, in view of Khardekar et al. (US 20130231899 A1), herein referred to as Khardekar.
Regarding claims 57-58, Chekhonin discloses the system of claim 54 (refer to Paragraph [0115]),, wherein the computer-program instructions, when executed by the one or more processors, cause the system to convert the intraoral scan into the 3D dental model (305; refer to Paragraphs [0131], [0238], [0391], Fig. 44; the scan of the patient's teeth is digitized to a 3D model).
Chekhonin does not disclose the system comprising an intraoral scanner.
Khardekar discloses a system (550) for IPR planning in the same field of endeavor (refer to Paragraph [0056]; Fig. 5) further comprising an intraoral scanning device (582) configured to take a scan of the patient's teeth (refer to Paragraph [0061]; the scanning device scans the patient’s dentition directly, therefore being an intraoral scanner). The addition of the intraoral scanning device (582) to the system is beneficial for inputting data into the computing device (552) to be stored (refer to Paragraph [0063]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Chekhonin with an intraoral scanning device (582) as taught by Khardekar in order to input and store the received scan data (refer to Paragraph [0063]).
Response to Arguments
The outstanding objections of claims 38 and 54 are withdrawn in view of the newly submitted claim amendment.
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that claims 38-58 integrate the exception into a practical application, Examiner disagrees. The method does not improve the functioning of a computer or technology, rather the method of interproximal adjustment, which is a manual process performed by orthodontists in observing and deciding treatment for patients, is improved by the technological aspects. A decision tree prediction model is a mathematical algorithm for implementing this mental process. A practical application of this method is found in claim 59, where the actual aligner associated with the treatment plan is formed. As suggested in the 35 U.S.C. 101 rejection above, Examiner recommends amending the independent claims to include the forming step of claim 59.
In response to Applicant’s argument that Chekhonin does not anticipate the amended independent claims 38 and 54, Examiner points to the above rejection in which different sections of Chekhonin are mapped that disclose the amended claim limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 10:00-7:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADRIENA J WEBB LYTTLE/ Examiner, Art Unit 3772
/EDELMIRA BOSQUES/ Supervisory Patent Examiner, Art Unit 3772
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