DETAILED ACTION
Applicant' s response, filed 09 June 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-20 are pending and examined herein.
Claims 1-20 are rejected.
Priority
Claims 1-20 are granted the claim to the benefit of priority to U.S. application 13/365117 filed 02 February 2012. Thus, the effective filling date of claims 1-20 is 02 February 2012.
Drawings
The objection to the drawings in Office action mailed 09 March 2026 is withdrawn in view of the amendment to specification which provides the reference character 560 for Fig. 5 received 09 June 2026.
Claim Interpretation
Claim 1 recites “creating the at least one aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth” and claim 11 recites “creating the aligner based on the virtually adjusted location or orientation of the dental attachment to cause the at least one of the desired force and the desired torque to be tooth to be applied to the tooth”. The BRI of these limitations encompass virtually creating an aligner based on the virtually adjusted attachment location or orientation (see instant disclosure [0059] and [0066]).
112/f Claim Interpretation:
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a manufacturing system configured to create the aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth” in claim 5.
“wherein the manufacturing system is further configured to create the dental attachment” in claim 6.
The instant disclosure does not provide an associated structure of a manufacturing system configured to create the aligner and further configured to create the dental attachment.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
112/a written description in view of 112/f claim interpretation:
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection below is newly recited necessitated by amendment.
Claims 5-10 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 recites “a manufacturing system configured to create the aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth” and claim 6 recites “wherein the manufacturing system is further configured to create the dental attachment”. The instant disclosure provides “Virtual dental models from a scan of a patient's dentition can be provided with computer-aided design and/or manufacturing systems, including tooth-treatment systems” (instant disclosure [0022]). However, there is not an adequate written description of the corresponding structure of the manufacturing system that is configured to create the aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth or that manufacturing system that is further configured to create the dental attachment. Dependent claims 7-10 and 18 are rejected by virtue of their dependency on a rejected claim without alleviating the issue.
112/b indefiniteness rejection in view of 112/f claim interpretation:
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.
The rejection below is newly recited necessitated by amendment.
Claims 5-10 and 18 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.
Claim limitations of “a manufacturing system configured to create the aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth” in claim 5 and “wherein the manufacturing system is further configured to create the dental attachment” in claim 6 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
There is an insufficient disclosure of “a manufacturing system configured to create the aligner based on the virtually adjusted attachment location or orientation…” and “wherein the manufacturing system is further configured to create the dental attachment”. The instant disclosure provides “Virtual dental models from a scan of a patient's dentition can be provided with computer-aided design and/or manufacturing systems, including tooth-treatment systems” (instant disclosure [0022]). The instant disclosure does not provide the corresponding structure of the manufacturing system that is configured to create an aligner or the corresponding structure of the manufacturing system that is configured to create a dental attachment. Dependent claims 7-10 and 18 are rejected by virtue of their dependency on a rejected claim without alleviating indefiniteness. For the sake of furthering examination, the system of claim 5 is interpreted as including a system which is configured to create a physical aligner and dental attachment.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
The rejection below has been modified necessitated by amendment.
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.
(Step 1)
Claims 1-4, 16, and 17 fall under the statutory category of a process and claims 5-15 and 18-20 fall under the statutory category of a machine.
(Step 2A Prong 1)
Under the BRI, the instant claims recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mental process”, such as procedures for evaluating, analyzing or organizing information, and forming judgement or an opinion. The instant claims further recite judicial exceptions that are an abstract idea of the type that is in the grouping of a “mathematical concept”, such as mathematical relationships and mathematical equations.
Claim 1 recites mental processes of “determining at least one of a desired force and a desired torque to be applied to the tooth by an aligner such that the tooth moves…”, “determining a placement area on the tooth for a dental attachment to achieve the at least one of the desired force and the desired torque to be applied to the tooth in response to interaction…”, “determining an attachment location or orientation in the placement area on tooth…”, “adjusting the attachment location or orientation in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from… estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location… comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque” and “creating the at least one aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth”.
Claim 5 recites mental processes of “determine at least one of a desired force and a desired torque to be applied to the tooth by an aligner…”, “determine a placement area on the tooth for a dental attachment to achieve at least one of the desired force and the desired torque to be applied…”, “determine an attachment location or orientation in the placement area on the tooth…”, and “adjusting the attachment location or orientation in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from… estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location… comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque”.
Claim 11 recites mental processes of “determine at least one of a desired force and a desired torque to be applied to the tooth to reach the desired position…”, “determine a placement area for the dental attachment on the tooth to achieve…”, “adjusting a location or orientation of the dental attachment in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from… determining at least one of an estimated actual force and an estimated actual torque… comparing the at least one of the estimated actual force and the estimated actual torque to the corresponding at least one of the desired force and the desired torque”, and “creating the aligner based on the virtually adjusted location or orientation of the dental attachment to cause the at least one of the desired force and the desired torque to be applied to the tooth”.
Claim 1 recites mathematical concept of “determining at least one of a desired force and a desired torque to be applied to the tooth by an aligner such that the tooth moves…” and “estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location…”.
Claim 5 recites mathematical concept of “determine at least one of a desired force and a desired torque to be applied to the tooth by an aligner…” and “estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location…”.
Claim 11 recites mathematical concept of “determine at least one of a desired force and a desired torque to be applied to the tooth to reach the desired position…” and “determining at least one of an estimated actual force and an estimated actual torque”.
Dependent claim 2 recites a mental process and mathematical concept of “determining a force to cause the tooth to move once bone breakdown of the tooth has occurred”. Dependent claim 3 recites a mental process of “determining the placement area on the tooth based on a center of mass of the tooth associated with the at least one of the desired force and torque to be applied to the tooth”. Dependent claim 4 recites a mental process of “determining the placement area on the tooth based on a center of resistance of the tooth associated with the at least one of the desired force and torque to be applied to the tooth”.
The claims recite mental processes of determining at least one of a desired force and a desired torque to be applied to the tooth by an aligner such that the tooth moves (which encompasses performing an analysis to determine a desired force and desired torque to move a tooth to a particular position), determining a placement area on the tooth for a dental attachment to achieve the at least one of the desired force and the desired torque to be applied to the tooth in response to interaction (which encompasses making a judgement about a placement area for a dental attachment based on criteria of achieving a desired force or desired torque), determining an attachment location or orientation in the placement area on tooth (which encompasses making a judgement about an attachment location or orientation based on certain criteria), adjusting the attachment location or orientation in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from… estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location… comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque (which encompasses making a judgement adjusting the attachment location or orientation, analyzing the attachment location or orientation by estimating an actual force and actual torque generated by the dental attachment at the attachment location or orientation, and making an observation and judgment based on force and torque information derived from an analysis of dental data), creating the at least one aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth (which encompasses generating parameters of an aligner based on the adjusted attachment location or orientation to cause a desired force and desired torque). The human mind is capable of determining desired a desired force and desired torque to move position of a tooth utilizing information describing position of a tooth, making judgements about placement areas of a tooth based on criteria, making judgments about attachment locations or orientations of an attachment, adjusting locations of an attachment and estimating the resulting force and torque generated based on an adjusted location, making a comparison between the estimated resulting force and torque and the desired force and desired torque, and generating parameters of the aligner based on the adjustment of the placement location.
The claims recite mathematical concepts of mathematical calculations of determining at least one of a desired force and a desired torque to be applied to the tooth to reach the desired position and determining at least one of an estimated actual force and an estimated actual torque (which encompasses mathematical calculations of computing/calculating and recalculating force and torque [0065] and [0071]). The MPEP provides “There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation” (see MPEP 2106.04(a)(2)(I)(C)). The BRI of these limitations encompass mathematical calculations of forces and torques.
Dependent claims 9, 14, and 15 further limit the mental process/mathematical concept recited in the independent claim but do not change their nature as a mental process/mathematical concept. Thus, the claims recite abstract ideas.
(Step 2A Prong 2)
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). Integration into a practical application is evaluated by identifying whether there are any additional elements recited in the claim and evaluating those additional elements to determine whether they integrate the exception into a practical application.
The additional element in claim 1 of using a generic computer to perform judicial exceptions, the additional element in claim 5 of a computing device including a processor and a memory where the processor is configured to execute instructions stored in the memory, the additional element in claim 11 of a non-transitory computing device readable medium having executable instructions executed by a processor to cause a computing device do not integrate the judicial exceptions into a practical application because this is applying the judicial exception to a generic computer without an improvement to computer technology. These additional elements of the generic computer (or a non-transitory computing device readable medium) only interact with the judicial exceptions in a manner where the generic computer is used as a tool to perform the judicial exceptions.
The additional element in claim 1 of receiving a desired position of the tooth included in initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient, the additional element in claim 5 of an imaging device to scan a patient's dentition to generate initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient, the additional element in claim 5 of receive, from the imaging device, the IOD, the additional element in claim 5 of receive a desired position of the tooth included in the IOD, the additional element in claim 8 of wherein the imaging device is an intra-oral scanner, the additional element in claim 11 of receive a desired position of a tooth of a patient included in initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient do not integrate the judicial exceptions into a practical application, and the additional element in claims 17, 18, and 20 of receiving, from a user interface, one or more user inputs modifying at least one of a location, an orientation, and a shape of the dental attachment because this adding insignificant extra solution activity of data gathering. These additional elements only interact with the judicial exceptions in manner by providing data to be processed by the judicial exceptions.
The additional elements in claims 5 and 6 of a system which is configured to create a physical aligner and the system is further configured to create a dental attachment do not integrate the judicial exceptions into a practical application because it amounts to generally linking the judicial exceptions to a particular technological environment of a manufacturing system configured to create an aligner and dental attachment (see MPEP 2106.05(h)). This manufacturing system is interpreted as generally linking the judicial exceptions to the technical environment of a system configured to create an aligner and dental attachment because the judicial exceptions of determining a desired force and torque, determining positions of an attachment, adjusting the attachment location or orientation, estimating an actual force and actual torque and comparing the at least one of the actual force and actual torque to the desired torque and desired force is generally linked to the system that is able to create the aligner.
The additional element in claims 7, 10, 12, 13, and 16-20 of a display that displays dental data such as a tooth, the attachment location or orientation in the placement area of the tooth, the virtual adjusting of the attachment location or orientation (which is interpreted as displaying the location or orientation of the attachment), and representations of desired force and desired torque and a representation of the actual force and actual torque generated by the attachment location or orientation do not integrate the judicial exceptions into a practical application because this is adding insignificant extra solution activity of outputting data. The additional element of the display for displaying dental data only interacts with the judicial exceptions by providing an output of the judicial exceptions which processes dental data. It is noted that the content of the representation of the force and torque data does not change the active step of displaying on a display and the content of the data falls under the abstract idea itself while the display of a tooth and attachment location or orientation is interpreted as rendering a display of a tooth along with information about the attachment location or orientation.
Thus, the additional elements do not integrate the judicial exceptions into a practical application and claims 1-20 are directed to the abstract idea.
(Step 2B)
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). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
The additional element in claim 1 of using a generic computer to perform judicial exceptions, the additional element in claim 5 of a computing device including a processor and a memory where the processor is configured to execute instructions stored in the memory, the additional element in claim 11 of a non-transitory computing device readable medium having executable instructions executed by a processor to cause a computing device are conventional as shown by MPEP 2106.05(b) and MPEP 2106.05(d)(II).
The additional element in claim 1 of receiving a desired position of the tooth included in initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient, the additional element in claim 5 of receive a desired position of the tooth included in the IOD, the additional element in claim 11 of receive a desired position of a tooth of a patient included in initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient, and the additional element in claims 17, 18, and 20 of receiving, from a user interface, one or more user inputs modifying at least one of a location, an orientation, and a shape of the dental attachment are conventional as shown by MPEP 2106.05(b) and MPEP 2106.05(d)(II). It is noted that the content of the data does not change the active step of receiving data in a computer environment and the content of the data falls under the abstract idea.
The additional element in claim 5 of an imaging device to scan a patient's dentition to generate initial orthodontic data (IOD), the additional element in claim 5 of receive, from the imaging device, the IOD, and the additional element in claim 8 of wherein the imaging device is an intra-oral scanner are conventional as shown by Wen et al. (US 20100009308 A1; previously cited), Knopp (US 20100092907 A1; previously cited), and Morton et al. (US 20100138025 A1; previously cited) which all show imagining devices with Wen et al. and Knopp showing the imaging device being an intraoral scanner.
The additional elements in claims 5 and 6 of a system which is configured to create a physical aligner and dental attachment is conventional as shown by Hilliard (US 20080141534 A1; newly cited) (Fig. 7 and claim 1) and Hilliard (US 20080254402 A1; newly cited) (Fig. 2, Fig. 3, Fig. 4, and [0063]).
The additional element in claims 7, 10, 12, 13, and 16-20 of a display that displays dental data such as a tooth, the attachment location or orientation in the placement area of the tooth, the virtual adjusting of the attachment location or orientation (which is interpreted as displaying the location or orientation of the attachment), and representations of desired force and desired torque and a representation of the actual force and actual torque generated by the attachment location or orientation is conventional as shown by MPEP 2106.05(b) and MPEP 2106.04(d)(II). It is noted that the content of the representation of the force and torque data does not change the active step of displaying on a display and the content of the data falls under the abstract idea itself because it is determined as an output of the judicial exceptions, while the display of a tooth and attachment location or orientation is interpreted as rendering a display of a tooth along with information about the attachment location or orientation. It is noted that rendering a display of a tooth and information about attachment location or orientation is conventional as shown by Kitching et al. (US 20080305454 A1; newly cited) (Fig. 6 and [0054]), Sterental et al. (US 20080305452 A1; newly cited) (Fig. 4 and [0034]), and Kitching et al. (US 20080305451 A1; newly cited) (Fig. 8, Fig. 10, and [0093]).
Thus, the additional elements are not sufficient to amount to significantly more than the judicial exception because they are conventional.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive.
Applicant argues the claims are directed to methods, systems and non-transitory computing device readable media for designing orthodontic appliances involving virtually and iteratively adjusting attachment location or orientation to reach at least a desired force and/or a desired torque applied to a tooth, and create an aligner configured to apply specific forces to the tooth based on the virtual adjusting. These steps cannot be practically performed in the human mind. For example, "estimating ... actual force and torque generated ... based on interaction between the aligner and the dental attachment" requires biomechanical modeling of contact interactions; "iteratively adjusting ... location or orientation" based on force comparisons requires repeated quantitative simulation; and the process creates an aligner. Therefore, the claims are not directed to a mental process. Further, the claims do not recite a mathematical relationship or formula; and therefore, are not directed to a mathematical concept (Reply p. 11).
This argument has been fully considered but found to be not persuasive. As described above, adjusting attachment location or orientation to reach a desired force and/or desired torque encompasses making judgements about attachment locations and orientations (it is interpreted that “virtually” is an indication that this is performed using a computer as a tool). It is noted that creating an aligner in the context of the method and non-transitory computer readable medium encompass creating an aligner through setting physical parameters of an aligner performed using a computer as a tool. Further, estimating actual force and torque encompasses analyzing parameters from an aligner and dental attachment to determine a quantitative estimate of force and torque using mathematical processes (a human mind is capable of estimating quantitative values of force and torque using mathematical processes and it is noted that this limitation further recites a mathematical calculation as described above) and iteratively adjusting an attachment location or orientation encompasses a series of judgments which adjusts a location or orientation during the analysis of determining a location or orientation which provides a desired force and/or torque.
Applicant argues even if the claims were construed as reciting an abstract idea, the claims integrate the purported abstract idea into a practical application (Step 2A Prong 2). The claims are rooted in a specific technological field-orthodontic appliance design-and operates on patient-specific tooth data (IOD) to model physical interactions between an aligner and a dental attachment. They further recite iterative adjustment of attachment location or orientation to achieve desired force and torque and culminates in creating an aligner configured to produce those forces. Thus, the claim is not directed to mere data analysis, but to a concrete design and manufacturing process that yields a functional medical device with prescribed performance. Under USPTO guidance, applying calculations to control or design a physical system constitutes a practical application, and here, the claims recite how forces are applied to a tooth via a fabricated aligner, resulting in a tangible technological outcome (Reply p. 11).
This argument has been fully considered but found to be not persuasive. It is noted that creating an aligner in the context of the method and non-transitory computer readable medium encompass creating an aligner through setting physical parameters of an aligner performed using a computer as a tool. Thus, under the BRI of the claimed method and non-transitory computer readable medium which causes a computer to perform steps a physical medical device (i.e., aligner) is not created, rather an aligner design is created which falls under the abstract idea of a mental process because the human mind is capable of defining parameters of an aligner design. Further, as described above the manufacturing system configured create an aligner and dental attachment constitutes as generally linking the judicial exceptions to the particular technological environment of manufacturing systems of aligners and dental attachments.
Applicant argues further, the claims recite an inventive concept that amounts to significantly more than any alleged abstract idea (Step 2B). The claims are not merely calculating force. They require iteratively adjusting attachment location/orientation based on simulated outcomes until desired \ conditions are achieved. This is a specific solution to a technical problem: how to reliably generate prescribed forces using removable aligners. As a whole, the claims reflect a non-routine, non-conventional approach to designing orthodontic appliances, far beyond "apply a formula" or "compare results." (Reply p. 11-12).
This argument has been fully considered but found to be not persuasive. The MPEP states “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry” which shows the analysis for conventionality is reserved for additional elements (see MPEP 2106.05(d)). It is noted that iteratively adjusting attachment location/orientation based on outcomes of an analysis until desired conditions are achieved is part of the abstract idea (i.e., not an additional element). Thus, the process of iteratively adjusting attachment location/orientation based on outcomes of an analysis is not analyzed for conventionality and cannot provide significantly more than the judicial exception because this process is part of the judicial exception. Further, the MPEP states at 2106.05(a) “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements… In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception”. The argued improvement is provided by the judicial exceptions alone of iteratively adjusting attachment locations/orientations, analyzing forces, and encompasses creating aligner designs which invokes a computer as a tool. Thus, the claims as a whole do not provide an improvement to a technology.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The rejection below has been modified necessitated by amendment.
Claims 1, 3-6, 9, 11, and 14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Morton et al. (US 20100138025 A1; previously cited).
Claim 1 is directed to a method of forming at least one aligner based on virtually testing force placed on a tooth of a patient, comprising: receiving a desired position of the tooth included in initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient
Morton et al. shows receiving a desired final position of the teeth along with a digital data set that represents the initial arrangement of the teeth and other tissues of a patient (Morton et al. [0079]-[0082]).
determining at least one of a desired force and a desired torque to be applied to the tooth by the aligner such that the tooth moves from an initial position to the desired position
Morton et al. shows determining an orthodontically optimal amount of force to be applied to the tooth that will move the teeth on a defined treatment path from an initial position to the desired position ([0082]-[0085]).
determining a placement area on the tooth for a dental attachment to achieve the at least one of the desired force and the desired torque to be applied to the tooth in response to interaction between the aligner and the dental attachment, determining an attachment location or orientation in the placement area on the tooth for the dental attachment;
Morton et al. shows a providing a patient specific attachment and for positioning the attachment on a tooth of a patient by determining constraints for positioning the attachment and then determining a current position for the attachment such that the attachment is positioned inside the constrained boundary (Morton et al. [0148]-[0149]).
virtually adjusting the attachment location or orientation in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from the initial position to the desired position, wherein virtually adjusting the attachment location or orientation in the placement area iteratively comprises iteratively:
Morton et al. shows an iterative process of adjusting attachment location in the constrained boundary to reach a solution where the attachment that will result in the desired movement of the tooth (Morton et al. [0148]-[0153]).
estimating at least one of an actual force and actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque
Morton et al. shows attachment design and optimization may include predicting a force system applied to the tooth with use of a selected attachment, and may include further modification or adjustment of one or more attachment parameters (Morton et al. [0060]). Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (Morton et al. [0064]- [0066]).
and creating the at least one aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth.
Morton et al. shows when the attachment provides a solution that will result in the desired movement of the tooth, the solution is applied to the treatment of the patient where the solution is the attachment that provides the desired movement of the tooth (Morton et al. [0153]). Morton et al. shows a dental aligner and/or attachment may be designed, manufactured, or simulated using a computer aided design tool or system (Morton et al. [0118]).
Claim 3 is directed to wherein determining the placement area on the tooth includes determining the placement area on the tooth based on a center of mass of the tooth associated with the at least one of the desired force and torque to be applied to the tooth.
Morton et al. shows parameters of an active attachment surface such as the mass center of the clipping plane associated with the tooth and desired force (Morton et al. [0160] and Fig. 27).
Claim 4 is directed to wherein determining the placement area on the tooth includes determining the placement area on the tooth based on a center of resistance of the tooth associated with the at least one of the desired force and torque to be applied to the tooth.
Morton et al. an attachment is controlled by several parameters so that the shape of the attachment and the position of the attachment on a tooth are patient specific and provide optimal force and torque (Morton et al. [0131]). Morton et al. shows that the torque is calculated with respect to a center of resistance of the tooth (Morton et al. [0132]).
Claim 5 is directed to a system comprising: an imaging device to scan a patient's dentition to generate initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient
Morton et al. shows imaging a patients dentition to generate a digital data set that represents the initial arrangement of the teeth and other tissues of a patient (Morton et al. [0079]-[0080]).
a computing device including a processor and a memory, the processor configured to execute instructions stored in the memory to: receive, from the imaging device, the IOD, receive a desired position of the tooth included in the IOD
Morton et al. shows receiving a desired final position of the teeth along with a digital data set that represents the initial arrangement of the teeth and other tissues of a patient (Morton et al. [0079]-[0082]). Morton et al. shows a computer system for performing the processes of computer simulations (Morton et al. [0167]-[0169]).
determine at least one of a desired force and a desired torque to be applied to the tooth by an aligner such that the tooth moves from an initial position to the desired position
Morton et al. shows determining an orthodontically optimal amount of force to be applied to the tooth that will move the teeth on a defined treatment path from an initial position to the desired position ([0082]-[0085]).
determine a placement area on the tooth for a dental attachment to achieve at least one of the desired force and the desired torque to be applied to the tooth based on the aligner interacting with the dental attachment, determine an attachment location or orientation in the placement area on the tooth for the dental attachment
Morton et al. shows a providing a patient specific attachment and for positioning the attachment on a tooth of a patient by determining constraints for positioning the attachment and then determining a current position for the attachment such that the attachment is positioned inside the constrained boundary (Morton et al. [0148]-[0149]).
virtually adjusting the attachment location or orientation in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from the initial position to the desired position, wherein virtually adjusting the attachment location or orientation in the placement area iteratively comprises iteratively:
Morton et al. shows an iterative process of adjusting attachment location in the constrained boundary to reach a solution where the attachment that will result in the desired movement of the tooth (Morton et al. [0148]-[0153]).
estimating at least one of an actual force and actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque
Morton et al. shows attachment design and optimization may include predicting a force system applied to the tooth with use of a selected attachment, and may include further modification or adjustment of one or more attachment parameters (Morton et al. [0060]). Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (Morton et al. [0064]- [0066]).
and a manufacturing system configured to create the aligner based on the virtually adjusted attachment location or orientation to cause the at least one of the desired force and the desired torque to be applied to the tooth
Morton et al. shows when the attachment provides a solution that will result in the desired movement of the tooth, the solution is applied to the treatment of the patient where the solution is the attachment that provides the desired movement of the tooth (Morton et al. [0153]). Morton et al. shows a dental aligner and/or attachment may be manufactured using a computer aided design tool or system which is interpreted as showing a manufacturing system (Morton et al. [0118]).
Claim 6 is directed to wherein the manufacturing system is further configured to create the dental attachment.
Morton et al. shows a dental aligner and/or attachment may be manufactured using a computer aided design tool or system which is interpreted as showing a manufacturing system (Morton et al. [0118]).
Claim 9 is directed to wherein the IOD includes an initial virtual dental model of an initial tooth arrangement of the patient.
Morton et al. shows a digital data set that represents the initial arrangement of the teeth and other tissues of a patient (Morton et al. [0079]-[0080]).
Claim 11 is directed to a non-transitory computing device readable medium having executable instructions executed by a processor to cause one or more computing devices to: receive a desired position of a tooth of a patient included in initial orthodontic data (IOD), wherein the IOD includes tooth data of the patient
Morton et al. shows receiving a desired final position of the teeth along with a digital data set that represents the initial arrangement of the teeth and other tissues of a patient (Morton et al. [0079]-[0082]). Morton et al. shows a computer system for performing the processes of computer simulations (Morton et al. [0167]-[0169]).
determine at least one of a desired force and a desired torque to be applied to the tooth to reach the desired position, wherein the at least one of the desired force and the desired torque are applied using a dental attachment by interaction with an aligner
Morton et al. shows determining an orthodontically optimal amount of force to be applied to the tooth that will move the teeth on a defined treatment path from an initial position to the desired position ([0082]-[0085]).
determine a placement area for the dental attachment on the tooth to achieve the at least one of the desired force and the desired toque to be applied to the tooth in response to an interaction between the aligner and the dental attachment
Morton et al. shows constraints for positioning the attachment are detected and a current position for the attachment is then set such that the attachment is positioned inside a constrained boundary (Morton et al. [0149], Fig. 24, and Fig. 25). Morton et al. an attachment is controlled by several parameters so that the shape of the attachment and the position of the attachment on a tooth are patient specific and provide optimal force and torque (Morton et al. [0131] and [0132]).
virtually adjusting a location or orientation of the dental attachment in the placement area iteratively to reach the at least one of the desired force and the desired torque to move the tooth from an initial position to the desired position, wherein virtually adjusting the location or orientation of the dental attachment comprises iteratively:
Morton et al. shows an iterative process of adjusting attachment location in the constrained boundary to reach a solution where the attachment that will result in the desired movement of the tooth (Morton et al. [0148]-[0153]).
determining at least one of an estimated actual force and an estimated actual torque generated by the dental attachment at the location or orientation in the placement area based on the interaction between the aligner and the dental attachment, comparing the at least one of the estimated actual force and the estimated actual torque to the corresponding at least one of the desired force and the desired torque
Morton et al. shows attachment design and optimization may include predicting a force system applied to the tooth with use of a selected attachment, and may include further modification or adjustment of one or more attachment parameters (Morton et al. [0060]). Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (Morton et al. [0064]- [0066]).
and creating the aligner based on the virtually adjusted location or orientation of the dental attachment to cause the at least one of the desired force and the desired torque to be applied to the tooth.
Morton et al. shows when the attachment provides a solution that will result in the desired movement of the tooth, the solution is applied to the treatment of the patient where the solution is the attachment that provides the desired movement of the tooth (Morton et al. [0153]). Morton et al. shows a dental aligner and/or attachment may be designed or simulated using a computer aided design tool (Morton et al. [0118]).
Claim 14 is directed to wherein the IOD includes at least one of a gum structure and a mouth bone structure.
Morton et al. shows the initial data includes digital models with surrounding bone and soft tissue (Morton et al. [0080]).
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive.
Applicant argues Morton et al. does not show estimating at least one of an actual force and actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque (Reply p. 12).
This argument has been fully considered but found to be not persuasive. As described above, Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment (which is interpreted as estimating an actual force for a particular attachment design) and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (which is interpreted as a comparison step between an actual force and desired force) (Morton et al. [0064]- [0066]). Thus, Morton et al. shows the newly amended limitation.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The rejection below was preciously presented.
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morton et al. (US 20100138025 A1; previously cited) as applied to claim 1 under 35 U.S.C. 102 above, in view of in view of Martin (US 20100092905 A1; previously cited).
Claim 2 is directed to wherein determining at least one of the desired force and the desired torque to be applied to the tooth by the aligner includes determining a force to cause the tooth to move once bone breakdown of the tooth has occurred.
Morton et al. does not show wherein determining at least one of the desired force and torque to be applied to the tooth by the aligner includes determining a force to cause the tooth to move once bone breakdown of the tooth has occurred.
Like Morton et al., Martin shows orthodontic appliances useful for transferring corrective forces. Martin et al. shows repositioning of teeth is accomplished by attaching orthodontic forces to the rigid structure of a tooth which provides corrective forces (when maintained continuously) cause a response of bone breakdown (bone resorption) and bone deposition (Martin [0005]). Martin shows that the resorption of bone on one side of the root and the creation of new bone on the other drives tooth movement and that this process is triggered by optimal forces with subliminal and excessive forces will not be necessarily produce desired tooth movement (Martin [0005]-[0006]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have modified the desired force used for customizing dental appliances of Morton et al. with the optimal force which triggers desired tooth movement based on bone breakdown of Martin because this would provide a method of customizing dental appliances (i.e., aligners and attachments) to elicit an optimal force which moves teeth through the breakdown bone while avoiding subliminal and excessive forces which will not necessarily produce desired tooth movement (Martin [0006]). One would have a reasonable expectation of success because Morton et al. shows customizing dental appliances based on forces applied to a tooth to cause a desired movement from an initial position to a target position while Martin shows dental appliances for optimal forces which lead to bone breakdown and subsequently a desired movement of a tooth.
The rejection below has been modified necessitated by amendment.
Claims 7, 10, 12, 13, and 16-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morton et al. (US 20100138025 A1; previously cited) as applied to claims 1, 5 and 11 under 35 U.S.C. 102 above, in view of in view of Kuo (US 20100167225 A1; previously cited).
Claim 7 is directed to a display the tooth, the attachment location or orientation in the placement area on the tooth, and the virtual adjusting of the attachment location or orientation.
Morton et al. shows an iterative process of adjusting attachment location and attachment shape in the constrained boundary to reach a solution where the attachment that will result in the desired movement of the tooth (Morton et al. [0148]-[0153], Fig. 24, and Fig. 25).
Morton et al. does not explicitly show displaying this information.
Like Morton, Kuo shows modeling teeth of a patient to provide a customized treatment plan. Kuo shows the digital representation of the patient's initial teeth parameters is loaded into a software program and the chosen treatment is virtually applied to the digital teeth parameters (Kuo [0025] and Figure 8). Kuo further shows the virtual treatment may be a geometric representation of the forces that would be applied by the treatment (Kuo [0025] and Figure 8). Kuo shows the output may a visual representation, a mathematical description, or a combination thereof and a display of the target position and rotation of each individual tooth of the patient (Kuo [0026] and Figure 8).
Claim 10 is directed to a display to display: the initial virtual dental model of the initial tooth arrangement of the patient, a target virtual dental model of a tooth arrangement including the tooth at a desired location or orientation; and at least one of a desired force and a desired force movement on the tooth as a vector arrow, wherein the vector arrow shows at least one of a direction and a magnitude of the desired force.
Morton et al. in view of Kuo shows receiving a desired final position of the teeth along with a digital data set that represents the initial arrangement of the teeth and other tissues of a patient (Morton et al. [0079]-[0082]). Morton et al. shows determining an orthodontically optimal amount of force to be applied to the tooth that will move the teeth on a defined treatment path from an initial position to the desired position ([0082]-[0085]). Morton et al. shows a movement vector that establishes the direction of the applied force as well as the level of force and the properties which are necessary to reposition the tooth from the initial position to the target position (Morton et al. [0119]).
Claim 12 is directed to wherein the instructions are executed by the processor to cause the one or more computing devices to display, via a user interface: the at least one of the desired force and the desired torque via the user interface and the at least one of the estimated actual force and actual torque applied to the tooth by the dental attachment via the user interface. Claim 13 is directed to display, via a user interface: the at least one of the desired force and the desired torque as a first force vector arrow and a first torque vector arrow, respectively, showing a first direction and magnitude of the desired force and the desired torque; and the at least one of the estimated actual force and the desired torque as a second force vector arrow and a second torque vector arrow, respectively, showing a second direction and magnitude of the estimated actual force and the estimated actual torque.
Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (Morton et al. [0064]- [0066]).
Morton et al. does not explicitly show displaying this information from the simulation.
Kuo et al. shows displaying a set of output results from simulations of treatment processes (Kuo et al. [0004]). Kuo shows the output may a visual representation, a mathematical description, or a combination thereof and a display of the target position and rotation of each individual tooth of the patient (Kuo [0026] and Figure 8). It would have been obvious to one of ordinary skill in the art before the effective filling date to have displayed the visual representations of forces including vector arrow representations.
Claims 16 and 19 are directed to the method (16) and computer readable medium with instructions (19) further comprising displaying, on a display, one or more representations of the tooth and the attachment location or orientation in the placement area on the tooth.
Morton et al. shows an iterative process of adjusting attachment location and attachment shape in the constrained boundary to reach a solution where the attachment that will result in the desired movement of the tooth (Morton et al. [0148]-[0153], Fig. 24, and Fig. 25).
Morton et al. does not explicitly show displaying this information.
Kuo et al. shows displaying representations of the tooth on a display and displaying outputs of a simulation on a display (Kuo et al. [0004], [0046], [0047], and Fig. 8). It would have been obvious to one of ordinary skill in the art before the effective filling date to have displayed the attachment parameters which includes attachment locations on a tooth.
Claims 17, 18, and 20 are directed to the method (17), the system (18), and computer readable medium with instructions (20) further comprising: displaying, on a display, a representation of the at least one of the desired force and the desired torque and a representation of the actual force and the actual torque generated by the attachment location or orientation; receiving, from a user interface, one or more user inputs modifying at least one of a location, an orientation and a shape of the dental attachment; and iteratively updating the displayed representation of the at least one of the desired force and the desired torque and the representation of the actual force and the actual torque in response to the one or more user inputs.
Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment (which is interpreted as determining an estimated actual force through simulations) (Morton et al. [0060] and [0064]- [0066]). Morton et al. further shows making modifications to an attachment which is further analyzed in a simulation environment which is interpreted as receiving inputs which modify attachment parameters in a simulated environment (Morton et al. [0060] and [0064]-[0066]). Morton et al. shows a computer system including a display and input devices to provide an interaction with a user (Morton et al. [0167]-[0169]).
Morton et al. does not explicitly show displaying this information.
Kuo et al. shows performing a simulation of a first treatment process, displaying a set of output results from the simulation of a first treatment process, performing a simulation of a second treatment process, and displaying a set of output results from the simulation of the second treatment process which is interpreted as the ability to iteratively update the displayed representation of simulation output data on a display (Kuo et al. [0004]).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to combine reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have combined the process of customizing attachments of an aligner to exert a desired force on a tooth of a patient by simulating attachment locations and making modifications of the attachment locations of Morton et al. with the visual display that displays output from treatment simulations of Kuo because this provides a visual output that displays the analysis of attachment parameters that will result in the desired movement of a tooth in terms of mathematical forces which allow for the ability visualize the effect attachment parameters have on a virtual patient tooth (Kuo [0025], [0026], and Figure 8). One would have a reasonable expectation of success because Morton et al. shows an iterative process for creating features of attachments using a virtual dental model of a patient while Kuo shows the ability to display simulation outputs of treatments.
The rejection below was previously presented.
Claims 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morton et al. (US 20100138025 A1; previously cited) as applied to claim 5 under 35 U.S.C. 102 above, in view of Knopp (US 20100092907 A1; previously cited).
Claim 8 is directed to wherein the imaging device is an intra-oral scanner.
Morton et al. does not show the imaging device to be an intra-oral scanner.
Like Morton et al., Knopp shows obtaining initial tooth parameters using an imaging device for virtual modeling of teeth of a patient. Knopp shows obtaining initial tooth parameters through intraoral scanning (Knopp [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have substituted the imaging device of Morton et al. with the intraoral scanning of Knopp because these imagining devices are both used for collecting initial tooth parameters for virtual modeling of teeth for a patient and the use of the intraoral scanner would lead to predictable results of a particular imaging device to capture initial tooth parameters for virtual modeling of teeth.
The rejection below was previously presented.
Claims 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Morton et al. (US 20100138025 A1; previously cited) as applied to claim 11 under 35 U.S.C. 102 above, in view of Cinader et al. (US 20100260405 A1; previously cited).
Claim 15 is directed to wherein the dental attachment is chosen to perform a particular movement with respect to the tooth positioning in the IOD based on a particular malocclusion of the tooth.
Morton et al. does not show wherein the dental attachment is chosen to perform a particular movement with respect to the tooth positioning in the IOD based on a particular malocclusion of the tooth.
Like Morton et al., Cinader et al. shows virtual modeling teeth of a patient in the context of treatment by repositioning the teeth of the patient. Cinader et al. shows software may also include subprograms to assist in suggesting or selecting the proper appliances for treatment of the particular malocclusion at hand (Cinder et al. [0043]).
An invention would have been obvious to one or ordinary skill in the art if some motivation in the prior art would have led that person to combine reference teachings to arrive at the claimed invention. It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have combined the dental attachment customization of Morton et al. with the subprogram to assist in suggesting or selecting the proper appliances for treatment of the particular malocclusion at hand of Cinader et al. because this would allow for a computer to execute virtual dental attachment design while accounting for particular malocclusions and proper appliances are used for correction (Cinader et al. [0043]). One would have a reasonable expectation of success because Morton et al. shows virtual modeling teeth of a patient for customizing dental appliances while Cinader et al. shows a subprogram for selecting proper dental appliances to be used for particular malocclusions.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive.
Applicant argues Morton et al. in view of any of Martin, Kuo, Knopp and Cindar does not show estimating at least one of an actual force and actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque (Reply p. 12-13).
This argument has been fully considered but found to be not persuasive. As described above, Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment (which is interpreted as estimating an actual force for a particular attachment design) and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (which is interpreted as a comparison step between an actual force and desired force) (Morton et al. [0064]- [0066]). Thus, Morton et al. shows the newly amended limitation.
Double Patenting
The rejection on the ground of NSDP of claims 1 and 2 as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,417,431 in Office action mailed 09 March 2026 is withdrawn in view of the amendment of wherein virtually adjusting the attachment location or orientation in the placement area iteratively comprises iteratively: estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque received 09 June 2026.
The rejection on the ground of NSDP of claims 5-10 as being unpatentable over claim 1 of U.S. Patent No. 11,417,431 in view of Knopp (US 20100092907 A1; previously cited) in Office action mailed 09 March 2026 is withdrawn in view of the amendment of wherein virtually adjusting the attachment location or orientation in the placement area iteratively comprises iteratively: estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque received 09 June 2026.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The rejection below has been modified necessitated by amendment.
Claims 1-7, 9-14, and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 24 of U.S. Patent No. 11,417,431 (referred to hereinafter as ‘431) in view of Morton et al. (US 20100138025 A1; previously cited).
Regarding instant claims 1, 5, and 11, ‘431 shows receiving a desired position of a tooth of a patient included in initial orthodontic data (patent claim 1 lines 3-4), determining at least one of a desired force and torque to be applied to the virtual tooth such that the virtual tooth moves from an initial position to the desired position (patent claim 1 lines 5-6), determining a placement area and attachment location in the placement are on the virtual tooth (patent claim 1 lines 7-12), iteratively adjust the attachment location of the virtual dental attachment in the placement area to move the virtual tooth from an initial position to the desired position (patent claim 1 lines 15-19), creating an aligner and a dental attachment shaped in accordance with the virtual aligner and virtual attachment (patent claim 1 lines 20-24).
‘431 does not show wherein virtually adjusting the attachment location or orientation in the placement area iteratively comprises iteratively: estimating at least one of an actual force and an actual torque generated by the dental attachment at the attachment location or orientation based on the interaction between the aligner and the dental attachment; and comparing the at least one of the actual force and the actual torque to the corresponding at least one of the desired force and the desired torque, ‘431 does not explicitly show a system including an imaging device and manufacturing system for performing the method steps (claim 5), or a non-transitory computer readable medium for performing the method steps (claim 11).
Morton et al. shows a process which includes selecting an attachment design, and then determining the force system applied to the tooth by the orthodontic use of the attachment (which is interpreted as estimating an actual force for a particular attachment design) and further determining whether the predicted force system is suitable for eliciting the desired tooth movement (Morton et al. [0060]). Morton et al. further shows identifying a desired value range of tooth movement force or torque for eliciting the desired tooth movement and analyzing the force system resulting from attachment designs to make a determination if the attachment designs result in force applications falling inside or outside the desired force and desired torque ranges in the process of modifying attachment parameters (which is interpreted as a comparison step between an actual force and desired force) (Morton et al. [0064]- [0066]). Morton et al. shows a computer system for performing the processes of computer simulations and a device for imaging (Morton et al. [0079] and [0167]-[0169]). Morton et al. shows a dental aligner and/or attachment may be manufactured using a computer aided design tool or system which is interpreted as showing a manufacturing system configured to create the aligner (Morton et al. [0118]).
Regarding instant claim 2,‘431 shows determining a force to cause bone breakdown of the tooth (patent claim 2).
Regarding instant claims 3 and 4, Morton et al. shows parameters of an active attachment surface such as the mass center of the clipping plane associated with the tooth and desired force (Morton et al. [0160] and Fig. 27). Morton et al. an attachment is controlled by several parameters so that the shape of the attachment and the position of the attachment on a tooth are patient specific and provide optimal force and torque (which is based on a center of resistance of the tooth) (Morton et al. [0131] and [0132]).
Regarding instant claim 6, Morton et al. shows a dental aligner and/or attachment may be manufactured using a computer aided design tool or system which is interpreted as showing a manufacturing system configured to create the dental attachment (Morton et al. [0118]).
Regarding instant claims 7 and 16-20 , ‘431 shows displaying a virtual tooth and attachment and attachment locations on the virtual tooth (claim 1 lines 13-14). ‘431 shows receiving instructions from a user to adjust the attachment location of the virtual attachment (claim 1 lines 15-19). It would have been obvious to one of ordinary skill in the art to have displayed data regarding the iterative adjustment of the virtual attachment based on the force system analysis.
Regarding instant claim 9, ‘431 shows a virtual dental model as a virtual tooth which is displayed (Claim 1 lines 13-14).
Regarding instant claims 10, 12, 13, ‘431 shows displaying force data associated with the simulated analysis including displaying force vector arrows (patent claim 24). It would have been obvious to one of ordinary skill in the art to have displayed data regarding the analysis of dental data when designing dental appliances.
Regarding claim instant claim 14, Morton et al. shows Morton et al. shows the initial data includes digital models with surrounding bone and soft tissue (Morton et al. [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the iterative adjustment process to reach the at least one of the desired force or the desired torque of patent ‘431 to incorporate the process of adjusting a location of the attachment predicting the estimated force of the attachment to make a determination if this will elicit the desired force or desired torque of Morton et a. because the iterative adjustment based on estimated actual forces and comparisons of these forces to desired values allows for a systematic process for customizing patient specific attachment locations which elicit the desired force through iteratively performing computational simulations to determine actual estimated forces on candidate locations with an assessment of if the estimated forces are within a range of desired forces which move the tooth from an initial position to a desired position (Morton et al. [060] and [0064]-[0066]). One would have a reasonable expectation of success because both patent ‘431 and Morton et al. show virtual design of dental appliances through adjustment of attachments.
The rejection below is newly recited necessitated by amendment.
Claims 5 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,417,431 (referred to hereinafter as ‘431) in view of Morton et al. (US 20100138025 A1; previously cited) in view of Knopp (US 20100092907 A1; previously cited).
Regarding instant claim 5, ‘431 in view of Morton et al. renders claim 5 obvious as set out above.
‘431 in view of Morton et al. does not the imaging device being an intra-oral scanner of claim 8.
Like patent ‘431 in view of Morton et al., Knopp shows virtual modeling of dental data. Knopp shows using an imaging device of an intraoral scanner to obtain initial tooth parameters of a patient (Knopp [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filling date to have substituted the imaging device in the design process of ‘431 in view of Morton et al. with an intra oral scanner imaging device of Knopp because both ‘431 in view of Morton et al. and Knopp shows imaging devices for collecting initial patient dental data and would lead to predictable results of utilizing an intra oral scanner in the collection of initial orthodontic data from a patient in the computational design process of an aligner based on attachment location optimization which starts with receiving initial orthodontic data from a patient.
The rejection below was previously presented.
Claims 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,417,431 (referred to hereinafter as ‘431) in view of Morton et al. (US 20100138025 A1; previously cited), further in view of Cinader et al. (US 20100260405 A1; previously cited).
Regarding instant claim 11, instant claim 11 is unpatentable over the patent ‘431 in view of Morton et al. as shown above.
‘431 in view of Morton et al. does not show wherein the dental attachment is chosen to perform a particular movement with respect to the tooth positioning in the IOD based on a particular malocclusion of the tooth in claim 15.
Regarding claim 15, Cinader et al. shows software may also include subprograms to assist in suggesting or selecting the proper appliances for treatment of the particular malocclusion (Cinader et al. [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the invention to have combined the dental attachment customization of the patent ‘431 in view of Morton et al. with the subprogram to assist in suggesting or selecting the proper appliances for treatment of the particular malocclusion at hand of Cinader et al. because this would allow for a computer to execute virtual dental attachment design while accounting for particular malocclusions and proper appliances are used for correction (Cinader et al. [0043]). One would have a reasonable expectation of success because the patent ‘431 in view Morton et al. shows virtual modeling teeth of a patient for customizing dental appliances while Cinader et al. shows a subprogram for selecting proper dental appliances to be used for particular malocclusions.
Conclusion
No claims are allowed.
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.
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/J.E.H./Examiner, Art Unit 1685
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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