DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 6 objected to because of the following informalities: “Gnatic replicator” is unknown. The examiner infers that the applicant meant “Gnathic replicator”, a well-known dental device used to record and reproduce three-dimensional jaw movement during mastication. Appropriate correction is required.
Claim 8 objected to because of the following informalities: “the crowns/roots” lacks sufficient antecedent. The limitation should read “a plurality of crowns/roots” or “a crown/root”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim(s) 6 is 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.
The term “resultant data” in claim 6 is a relative term which renders the claim indefinite. The term “resultant data” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “resultant data” does not clearly specify whether the data refers to the functional occlusion data or data of oral anatomy or the combination of the functional occlusion data and the data of oral anatomy, as set forth in claim 1.
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) 1 – 2 and 4 – 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martz et al. (US 20180303581 A1) in view of Gantes (US 20160157970 A1).
Regarding claim 1, the limitations in steps d and e are contingent limitations due to the term “if” (see MPEP 2111.04II; “When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, "[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed").
Regarding claim 1, Martz et al. discloses a method for a treatment plan for orthodontic movement of natural teeth, the method comprising: a. Acquiring data of oral anatomy of a patient (paragraph 0037; scan of patients dental anatomy consisting upper and lower plaster model of the teeth, palate, and the gums); b. Creating a treatment plan for the patient for orthodontic movement of natural teeth, the end result of the treatment plan for the patient being a 3D model (paragraphs 0036 – 0039; describes a treatment plan for orthodontic movement of teeth and said tooth models for the treatment plan can be generated from 3D images of patient’s dentition); c. Printing out a physical model of 3D model (paragraph 0039; physical forming models are produced using any of a number of conventional processes, such as computer numerically-controlled (CNC) machining, stereo lithography, or 3D printing); e. Applying any corrections to the 3D model from the step of determining if malocclusion exists, to create functional occlusion data (paragraph 0037; describes a process of making corrective modifications to the acquired digital model of the original malocclusion to obtain an a virtual model with ideal occlusion); f. Combining the functional occlusion data with data of the oral anatomy of the patient to create a virtual treatment solution (paragraph 0037; two versions of patient’s dental data comprising the original malocclusion (data of the oral anatomy of the patient) and the ideal occlusion (functional occlusion data) which can be combined for the creation of a treatment plan); and g. Creating orthodontic appliances from the virtual treatment solution; whereby at least one of the above steps is accomplished without human intervention (paragraph 0050; appliance design is created from the treatment plan and some or all of the steps may be performed in an automated manner (i.e., without operator input)).
Martz et al. is silent regarding the method of a treatment plan for orthodontic movement of natural teeth comprising:d. Mounting the physical model of the maxillary arch and mandibular arch of the patient's oral anatomy onto a dental articulator to evaluate if at least one of the following exists: 2) if the functional occlusion data of the patient is in centric relation or 2) if malocclusion exists between the maxillary arch and the mandibular arch.
In the same field of endeavor, Gantes teaches an analogous method wherein the method comprising mounting the physical model of the maxillary arch and mandibular arch of the patient's oral anatomy onto a dental articulator to evaluate if at least one of the following exists: 2) if the functional occlusion data of the patient is in centric relation or 2) if malocclusion exists between the maxillary arch and the mandibular arch (paragraph 0141; the physical model of the patient’s oral anatomy is placed in a semi-adaptable articulator to confirm proper occlusion… the statement to confirm proper occlusion is interpreted by the examiner to encompass checking for malocclusion and proper occlusion. Also, paragraph 0113 describing the acquisition of the data of oral anatomy of a patients indicates patient’s mandible, maxilla, or both, and/or entire bony structure of the jaw as part of said data. Thus, it is reasonable to interpret that the resulting physical model of the patient’s oral anatomy would also include the mandibular and maxilla arches).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Martz et al. to include a step comprising mounting the physical model of the maxillary arch and mandibular arch of the patient’s oral anatomy onto a dental articulator to evaluate if at least one of the following exists: 2) if the functional occlusion data of the patient is in centric relation or 2) if malocclusion exists between the maxillary arch and the mandibular arch, as taught by Gantes. One of ordinary skill in the art would have been motivated to make this modification in order to mechanically generate initial occlusion and jaw movement data of the physical model which can be cross-referenced to any digital data that can be generated using virtual articulator or other analytical software programs for a better treatment plan.
Regarding claim 2, Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al. further discloses the method of claim 1, the patient data comprising a 3D mesh of the patient's oral anatomy, with teeth of the patient being separated, and with or without bite registration materials or devices to position the jaw (paragraphs 45 and 48; the digital dental model can be a polygonal mesh which is a 3D mesh. Also, the digital dental model can be generated directly from the dentition of the patient using intraoral scanner and it is generally known in the art that intraoral scanning can be done with teeth of the patient being separated and with or without bite registration materials).
Regarding claim 4, Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al. further discloses the method of claim 1, the orthodontic appliances being selected from the group of customized brackets, lingual/buccal braces, aligners, customized oral devices, and corrective oral devices for the patient (paragraphs 0002 and 0004; the dental appliances are orthodontic aligners…).
Regarding claim 5, Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al. further discloses the method of claim 1 further comprising reprinting 3D models to evaluate resultant occlusion in an articulation (paragraphs 37 – 39; describes an incremental, progressive series of physical forming models generated from virtual models that have undergone repositioning of the teeth according to a comprehensive and sequential procedure. These physical forming models are representative of the occlusion correction at different steps of the treatment plan).
Claim(s) 3 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martz et al. (US 20180303581 A1) in view of Gantes (US 20160157970 A1) and further in view of Jordan et al. (US 7347690 B2).
Regarding claim 3, Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al./Gantes is silent regarding the method of Claim 1 further comprising determining a maximum intercuspation position to evaluate the patient's occlusion, and functional and balancing interferences.
Jordan et al. teaches an analogous method comprising determining a maximum intercuspation position to evaluate the patient's occlusion, and functional and balancing interferences (Col. 7 lines 43 – 45; bite registration is defined as the location of the upper and lower dental arches of a patient in occlusion (e.g. maximum intercuspation), and Col. 12 lines 10 – 55; describes an algorithm that is designed to evaluate occlusion and interferences based on the determined bite registration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods disclosed by Martz et al./Gantes to include a step comprising determining a maximum intercuspation position to evaluate the patient's occlusion, and functional and balancing interferences, as taught by Jordan et al. One of ordinary skill in the art would have been motivated to make this modification in order to provide for the manipulation of the measured digital data representative of the upper and lower dental arches in accessing occlusion positions and interferences, as suggested by Jordan et al.
Regarding claim 7, Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al./Gantes is silent regarding the method of Claim 1, further comprising the step of determining if malocclusion exists by using a maximum intercuspation position to evaluate at least one of 1) the occlusion of the patient, 2) functional interferences, and 3) balancing interferences, whereby this step of determining if malocclusion exists is accomplished without human intervention.
Jordan et al. teaches an analogous method comprising the step of determining if malocclusion exists by using a maximum intercuspation position to evaluate at least one of 1) the occlusion of the patient, 2) functional interferences, and 3) balancing interferences, whereby this step of determining if malocclusion exists is accomplished without human intervention (Col. 7 lines 43 – 45; bite registration is defined as the location of the upper and lower dental arches of a patient in occlusion (e.g. maximum intercuspation), and Col. 12 lines 10 – 55; describes an algorithm that is designed to evaluate occlusion and interferences based on the determined bite registration, Col. 12 lines 3 – 6; the disclosed algorithm is a component of a dental articulation model creation program that can be accomplished without human intervention).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods disclosed by Martz et al./Gantes to include a step comprising determining a maximum intercuspation position to evaluate the patient's occlusion, and functional and balancing interferences, whereby this step of determining if malocclusion exists is accomplished without human intervention, as taught by Jordan et al. One of ordinary skill in the art would have been motivated to make this modification in order to develop a method that provides for the autonomous manipulation of the measured digital data representative of the upper and lower dental arches in accessing occlusion positions and interferences, as suggested by Jordan et al.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martz et al. (US 20180303581 A1) in view of Gantes (US 20160157970 A1) and further in view of Rubbert et al. (EP 2258303 B1).
Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al./Gantes is silent regarding the method of Claim 1 further comprising utilizing a Gnatic replicator to evaluate resultant data.
In the same field of endeavor, Rubbert et al. teaches an analogous method comprising utilizing a Gnatic replicator to evaluate resultant data (The examiner interprets Gnatic replicator as a dental device used to record and reproduce three-dimensional jaw movement during mastication or software program that can digitally perform same actions using a digital teeth/mouth model. The examiner interprets the “resultant data” as used in the claim language to mean functional occlusion data. See paragraph 0295 of EP 2258303 B1; describes a treatment planning software that can be able to stimulate chew motion and allow user to move the upper and lower jaws relative to each other thus allowing for evaluation of the occlusion data and adjustment of bite registration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods disclosed by Martz et al./Gantes to include a step comprising utilizing a Gnatic replicator to evaluate resultant result as taught by Rubbert et al. One of ordinary skill in the art would have been motivated to make this modification in order to make a treatment method that provides the user with the ability to test and validate each step of the occlusion treatment plan by running a virtual simulation of the jaw movements during mastication, as suggested by Rubbert et al.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martz et al. (US 20180303581 A1) in view of Gantes (US 20160157970 A1) and further in view of Andreiko et al. (US 20040115586 A1).
Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al./Gantes further discloses an analogous method combining the functional occlusion data with data of the oral anatomy of the patient to create a virtual treatment solution (paragraph 0037 US 20180303581 A1; two versions of patient’s dental data comprising the original malocclusion (data of the oral anatomy of the patient) and the ideal occlusion (functional occlusion data) which can be combined for the creation of a treatment plan) further comprising a solution: and c. Modifying the physical model (paragraph 143 US 20160157970 A1; the physical model (machined master replica (MMR)) of the patient’s oral structures can be modified in replication of the treatment plan to confirm the esthetic and functional quality of the treatment plan), then scanning the model (paragraph 0046 US 20180303581 A1; digital dental model can be generated by scanning the physical models thus, it would be obvious to scan the modifications to the physical models and integrate into the treatment plan) and integrating into the virtual treatment solution without human intervention (paragraph 0050 US 20180303581 A1; clearly states that some or all of these steps may be performed in an automated manner).
Martz et al./Gantes is silent regarding the step of combining the functional occlusion data with data of the oral anatomy of the patient to create a virtual treatment solution further comprising a solution selected from the group of: a. Making the changes manually by changing tooth dimensions, by moving the crowns/roots by centric occlusion or relation; b. Taking manual measurement by jig or millimetric rules and recording those changes in computer software program.
Andreiko et al. teaches an analogous method comprising a solution selected from the group of: a. Making the changes manually by changing tooth dimensions, by moving the crowns/roots by centric occlusion or relation (paragraph 0030; the heights of the cuspids and other teeth can be adjusted relative to each other so that the teeth can be positioned…); b. Taking manual measurement by jig or millimetric rules and recording those changes in computer software program (paragraphs 160 – 161; describes jigs been used to for measurements and making calculated positions on the teeth. Paragraph 161 describes the process of the manual measurements being recorded in the NC computer generated programs which is based on calculated patient data files).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods disclosed by Martz et al./Gantes to further comprise a solution selected from the group of: a. Making the changes manually by changing tooth dimensions, by moving the crowns/roots by centric occlusion or relation; b. Taking manual measurement by jig or millimetric rules and recording those changes in computer software program, as taught by Andreiko et al. One of ordinary skill in the art would have been motivated to make this modification in order to create an improved method of treatment that allows for the customization of the tooth dimensions to address issues such as underbites or overbites, and generation of manual measurements of the teeth positions which can be cross-referenced to the calculated and digital data to further ensure an effective and ideal treatment plan for the patient.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martz et al. (US 20180303581 A1) in view of Gantes (US 20160157970 A1) and further in view of Barthe et al. (WO 2012140021 A2).
Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al./Gantes further discloses an analogous method comprising: a. working in a software planning workflow whereby a STL file of the 3D model is created after the step of creating a treatment plan (paragraph 0047 – 0048 and 0056; … The appliance design engine 108 may generate a treatment plan and based on that treatment plan generate an appliance model 110 that is transmitted to the appliance fabrication system 112 for fabrication… the appliance fabrication system 112 is configured to receive files in the stereolithography (.STL) file format… as described above, the 3D model created after the treatment plan can be stored in .STL file format which can be sent to the appliance fabrication system 122 that is configured to receive .STL files); c. Adjusting the 3D model to compensate for any corrections needed (paragraph 0037; describes the process of extensive manipulation of the virtual malocclusion on a virtual model (3D model) to arrive at an ideal occlusion for the patient), whereby at least one of the above steps is accomplished without human intervention (paragraph 0050; the alignment of components which includes adjustment of the 3D model to generate a treatment plan can be performed in an automated manner).
Martz et al./Gantes is silent regarding Claim 9 further comprising: b. transferring the STL files to a virtual articulator to evaluate the bite function during virtual mastication and any corrections needed.
Barthe et al. teaches an analogous method that comprises transferring the STL files to a virtual articulator to evaluate the bite function during virtual mastication and any corrections needed (page 8, lines 1 – line 30; describes a process of accessing virtual jaw movements and occlusion of a 3D teeth model including corrections such as a virtual orthodontic element. An example of the digital data file could be a STL-file).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Martz et al./Gantes to include a step that comprises transferring the STL file to a virtual articulator to evaluate the bite function during virtual mastication and any correction needed, as taught by Barthe et al. One of ordinary skill in the art would have been motivated to make this modification in order to create a program that digitally accesses jaw and teeth movements for precise dental treatment planning and the application of necessary adjustments to the treatment plans.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martz et al. (US 20180303581 A1) in view of Gantes (US 20160157970 A1) and further in view of Sachdeva et al. (US 20140329194 A1).
Martz et al./Gantes discloses the claimed invention substantially as set forth in claim 1 above. Martz et al./Gantes is silent regarding Claim 1 further comprising one or more steps selected from the group: a. Scanning dental models or physical impressions taken of the teeth of the patient; b. Acquiring CBCT scan, x-ray, or intraoral scan of the patient's oral anatomy; c. Acquiring smile design image of the patient; and d. Acquiring craniofacial measurements of the skull and teeth of the patient; e. whereby at least one of the above steps is accomplished using without human intervention.
Sachdeva et al. teaches an analogous method comprising one or more steps selected from the group: a. Scanning dental models or physical impressions taken of the teeth of the patient (paragraph 0216; Surface scans of a patient's dentition are obtained using in-vivo scanning or other types of scanning such as scanning an impression of the patient's dentition or scanning a physical model of the patient's dentition...); b. Acquiring CBCT scan, x-ray, or intraoral scan of the patient's oral anatomy (paragraph 0085; … data could be intra-oral 3D scan data obtained from the hand-held scanner 30, CT scan data, X-Ray data, MRI, etc.); c. Acquiring smile design image of the patient (paragraph 0244; (e) data representing function of the patient's jaw movements and smile; wherein the data representing function of the patient's jaw movements and smile are obtained through video imaging, jaw tracking, or photographs); and d. Acquiring craniofacial measurements of the skull and teeth of the patient (paragraph 0082; These sets include at least a first set of digital data 24 representing patient craniofacial image information obtained from a first imaging device and a second set of digital data 26 representing patient craniofacial image information obtained from a second image device different from the first image device. The first and second sets of data represent, at least in part, common craniofacial anatomical structures of the patient. At least one of the first and second sets of digital data normally would include data representing the external visual appearance or surface configuration of the face of the patient); e. whereby at least one of the above steps is accomplished using without human intervention (paragraph 0087; discloses software tools for manipulating various parameters such as patient’s orientation, texture of the teeth, and visual appearance).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods disclosed by Martz et al./Gantes to comprise steps including a. Scanning dental models or physical impressions taken of the teeth of the patient; b. Acquiring CBCT scan, x-ray, or intraoral scan of the patient's oral anatomy; c. Acquiring smile design image of the patient; and d. Acquiring craniofacial measurements of the skull and teeth of the patient; e. whereby at least one of the above steps is accomplished using without human intervention, as taught by Sachdeva et al.
One of ordinary skill in the art would have been motivated to make this modification in order to create a method that allows for automated acquisition of patient’s dentition using alternate method of scanning dental impressions of the patient’s teeth, and craniofacial anatomy and features for the patient in order to provide an ideal orthodontic treatment plan for the patient.
ConclusionAny inquiry concerning this communication or earlier communications from the examiner should be directed to CHIEMERIE C AZUBUOGU whose telephone number is (571)272-0664. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:00PM.
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, Eric Rosen can be reached at (571)270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.A./ Patent Examiner, Art Unit 3772
/ERIC J ROSEN/ Supervisory Patent Examiner, Art Unit 3772