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 .
Response to Amendment
Applicant has submitted the following:
An Abstract (11/07/2025), to replace the previous Abstract (03/11/2022);
Claims 1-15 are pending examination;
Claim 1 is newly amended; and
Claims 14 and 15 are newly added.
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not fully persuasive.
Applicant argues that the replacement Abstract fully addresses the objection to the excessive length.
Examiner finds the objection fully addressed, and the objection to the Abstract is withdrawn.
Applicant argues that the newly amended claim 1 overcomes the rejection under 35 USC 112.
Examiner finds that the amendment addresses the rejection, and therefore the rejection under 35 USC 112 is withdrawn.
Applicant argues that, regarding the rejection of claims 1-13 under 35 USC 101, the recited claims integrate the abstract idea into a practical application. Specifically, Applicant argues that the determination of a stimulus for the change of shape of a medical aid, which “can be configured to slow down the movement to a medically recommended rate”, integrates the abstract idea into a practical application.
Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the corrective action by the stimulus) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). (see detailed action under claim rejections under 35 USC 103). Instead, the recited claims amount to detecting information (collecting information) and calculating values (performing analysis and/or mathematical calculations), which may be performed as mental processes and mathematical calculations. The claims as recited do not integrate the judicial exceptions into a practical application, and therefore are not patent eligible (see detailed action under claim rejections under 35 US 101).
Applicant argues that the prior art does not teach the recited claim limitations. Specifically, Applicant argues that cited Kitching teaches the use of multiple, sequential dental aligners as the medical aid instead of a single dental aligner. Applicant further argues that neither the cited Kitching or Kandil teaches a singular dental aligner and the calculation of a stimulus for a second (or more) target position.
Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., singular dental aligner) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Instead, the claim recites “a medical aid”, which, under broadest reasonable interpretation, includes any devices, systems, or processes that can render aid, assistance, teat or otherwise intervenes in medical processes. Examiner notes that Kitching teaches a medical aid (col 3 line 64 – col 4 line 2, “Treatment can be pre-planned for administering to a patient in a series of one or more phases, with each phase including a set of appliances that are worn successively by the patient to reposition the teeth through planned arrangements and eventually toward a selected final arrangement.”), The series of one or more phases, including a set of appliances for each phase, is the medical aid. Further, Kitching teaches said medical aid which changes shape (col 4 lines 49-52, “This method is enabled by using bite matching techniques to allow the current aligner geometry to be recalibrated and reshaped according to the actual position of the teeth in the progress scan.”), wherein the aligner geometry being “recalibrated and reshaped” is the change in shape.
Examiner further notes that cited Kitching in view of Kandil does teach to singular medical aid devices which change shape. Kitching teaches singular medical aid devices, both in traditional adjustable devices (col 1 lines 25-33, “An objective of orthodontics is to move a patient's teeth to positions where function and/or aesthetics are optimized. Traditionally, appliances such as braces are applied to the patient's teeth by an orthodontist or dentist and the set of braces exerts continual force on the teeth and gradually urges them toward their intended positions. Over time and with a series of clinical visits and adjustments to the braces, the orthodontist adjusts the appliances to move the teeth toward their final destination.”) and “aligner” devices (col 3 lines 64-65 “Treatment can be pre-planned for administering to a patient in a series of one or more phases”; and col 4 lines 10-15, “once initial staging of a patients teeth is completed (e.g., model initial, intermediate, and final teeth arrangements) and a treatment plan has been devised, a dental practitioner can be sent a first set of one or more appliances to be administered to the patient in the first phase of treatment.”). Further, Kandil teaches motivation to use as few devices as possible (“The individual method steps described above or the features of the orthodontic correction device can all be used individually or in combination in order to achieve an optimal, patient-friendly desired position of teeth and jaw. The aim is to achieve as far as possible a correction with a single correction device in order to burden the patient with as few changes of the correction device.”). (see detailed action under claim rejections under 35 USC 103).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention in each of these claims is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Specifically, representative Claim 1 recites:
“A method for calculating a stimulus for the change of shape of a medical aid in order to change the shape of the aid from an actual position to a final target state comprising the steps:
- detecting the actual position of a body part to be corrected after a first correction step in a control unit,
- comparing the actual position of the body part to be corrected with a target position that is stored in the control unit,
wherein the method further comprises the steps
- if applicable, detecting, by the control unit, the deviation between the actual position and target position of the body part to be corrected,
- calculating with the control unit the stimulus that has to act on the medical aid to perform a second correction step, taking into account the deviation between the actual state and target state of the body part to be corrected, wherein the effect of the stimulus on the medical aid is saved in the control unit.”
The claim limitations considered to fall within in the abstract idea are highlighted in bold font above; the remaining features are “additional elements.”
Step 1 of the subject matter eligibility analysis entails determining whether the claimed subject matter falls within one of the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: process, machine, manufacture, or composition of matter. Claim 1 recites a process and is therefore falls within a statutory category.
Step 2A, Prong One of the analysis entails determining whether the claim recites a judicial exception such as an abstract idea. Under a broadest reasonable interpretation, the highlighted portion of claim 1 comprises process steps that fall within the abstract idea judicial exception. Specifically, under the 2019 Revised Patent Subject matter Eligibility Guidance, the highlighted subject matter falls within the mental processes category.
Individually and collectively, the steps:
“detecting the actual position of the body part to be corrected”;
“comparing the actual position of the body part to be corrected with a target position”;
“detecting […] the deviation between the actual position and target position of the body part to be corrected”; and
“calculating […] the stimulus that has to act on the medical aid to perform a second correction step”
may be performed as mental processes. Detecting an actual position and deviation between said position and a target position is gathering information, which may be performed as mental processes. Comparing the actual position with the target position is an analysis, and may be performed as mental processes. Calculating the stimulus that has to act to perform a correction step is an analytical step, and may be performed as mental processes and/or mathematical calculations. The type of high-level information collecting and analyzing data recited in these elements has been found by the Federal Circuit to constitute patent ineligible matter (see Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016), a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind).
Step 2A, Prong Two of the analysis entails determining whether a claim includes additional elements that integrate the recited judicial exception (e.g., abstract idea) into a practical application. In view of the various considerations encompassed by the Step 2A, Prong Two analysis, claim 1 does not include additional elements that integrate the recited abstract idea into a practical application. Based on the individual and collective limitations of claim 1, applying a broadest reasonable interpretation, the most significant of such considerations appear to include: improvements to the functioning of a computer, or to any other technology or technical field (MPEP 2106.05(a)); applying the judicial exception with, or by use of, a particular machine (MPEP 2106.05(b)); and effecting a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)).
Regarding improvements to the functioning of a computer or other technology, the additional elements, including “the medical aid” and “the control unit”, are recited generically and do not integrate the judicial exception into a practical application. Any alleged improvement would be in the analytical steps (e.g. “comparing”, “detecting”, and “calculating” steps), and thus amount to an improvement in an abstract idea, which is not an improvement of technology (MPEP 2106.05(a).II “However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.”) The recitation of the “control unit” amounts to mere instructions to apply the instructions on a generic computer and do not integrate the judicial exception into a practical application (MPEP 2106.05(f)).
Regarding application of the judicial exception with, or by use of, a particular machine, the additional elements such as the “medical aid” and the “control unit” are not utilized as a particularized manner of implementing the abstract idea process steps. The specification does not include a particularized configuration of the medical aid (page 1, “Medical aids comprise numerous products, all of which can be used to reduce or heal physical or organic defects or illnesses.”; page 5, “In general, the medical aid can be produced from any material”) and the control unit (page 4, “The control unit is designed to process software or algorithms.”), as it relates to calculating a stimulus.
Regarding effectuation of a transformation or reduction of a particular article to a different state or thing, the claim includes no such transformation or reduction. Instead, the claim as a whole entails gathering information (e.g. “detecting” steps), analyzing said information (e.g. “comparing” and “calculating” steps). No transformation is claimed.
The above additional elements, considered individually and in combination with the claim elements reciting an abstract idea do not reflect an improvement to other technology or technical field, and, therefore, do not integrate the judicial exception into a practical application. Therefore, the claims are directed to a judicial exception and require further analysis under Step 2B.
Regarding Step 2B, independent claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because they are generically recited and are well-understood/conventional in the relevant art as evidenced by the prior art of record as indicated in the rejections under 35 U.S.C. §103.
Independent claim 1 is therefore patent eligible.
Dependent claims 2-13 provide additional features/steps which are part of an expanded algorithm that includes the abstract idea of the independent claims (Step 2A, Prong One). Claims 2 further detail the stimulus that is calculated. Claims 3-4 further details the detected positions. Claim 9 details the transferring of information (e.g. “parameters selected for the stimulation”) of the second correction step. Claim 10 details the creation of a data set. Claims 2-4, 9, and 10 amount to further details pertaining to the process steps, which may be performed as mental processes, and therefore do not recite additional elements that integrate the judicial exception into a practical application.
Dependent claims 5-8, and 11-13 further detail the control unit. Claim 5 recites the limitation that the control unit is connected to a treatment device, which is not recited in a particularized manner. Claim 6 recites the limitation that the control unit stores information (i.e. “temporal progression of the actual state of the body part”), which is not recited in a particularized manner. Claims 7 and 8 further recites analysis performed by the control unit (e.g. “takes into account the temporal progression of the actual states of the body part to be corrected when calculating the stimulus” and “calculates, emits and stores the duration of the second correction step, the size of the next stimulus, and/or the parameters selected for stimulation”), which may be performed as mental processes and/or mathematical calculations. Claims 11-13 recites an “input portal”, which, under broadest reasonable interpretation, includes any means of transferring or otherwise providing information, and is not utilized in a particularized manner.
Dependent claims 2-13 fail the “significantly more” test under the step 2B for the same reasons as discussed with regards to the independent claims. The dependent claims therefore are also ineligible subject matter.
Dependent claims 2-13 are therefore ineligible subject matter.
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitching (US 8562338 B2, previously cited) in view of Kandil (WO 2016193424 A1, previously cited).
Regarding claim 1, Kitching teaches A method for calculating a (col 3 line 64 – col 4 line 2, “Treatment can be pre-planned for administering to a patient in a series of one or more phases, with each phase including a set of appliances that are worn successively by the patient to reposition the teeth through planned arrangements and eventually toward a selected final arrangement.”) in order to change the shape of the aid from an actual position to a final target state (Abstract; col 4 lines 49-52, “This method is enabled by using bite matching techniques to allow the current aligner geometry to be recalibrated and reshaped according to the actual position of the teeth in the progress scan.”) comprising the steps:
- detecting the actual position of a body part to be corrected after a first correction step (col 6 lines 63-66, “After the treatment plan begins and following administration of appliances to the patient, teeth matching is done to assess a current and actual arrangement of the patient's teeth compared to a planned arrangement (Step 206).”; Fig. 5, col 9 lines 40-50 “First, data from an earlier treatment plan is received (Step 402). Typically, data includes the initial data set or image data representing the patient's teeth in the original, pre-treatment positions, the initially identified final position, as well as planned intermediate or successive arrangements selected for moving teeth along the initial treatment path from the initial arrangement to the selected final arrangement. Next, a current jaw impression or data including a digital representation of the teeth in their current positions, after treatment has begun, is received and loaded (Step 404).”) in a control unit (Fig. 10, data processing system 700),
- comparing the actual position of the body part to be corrected with a target position that is stored in the control unit (Fig. 3, step 206, “on-track” and “off-track”),
wherein the method further comprises the steps
- if applicable, detecting, by the control unit, the deviation between the actual position and target position of the body part to be corrected (Fig. 6, step 618; col 11 lines 32-38 “ a determination can be made as to whether positional differences exist, and to what degree, between the teeth in their current positions compared to the expected or planned positions. Positional differences may indicate whether the patient's teeth are progressing according to the treatment plan or if the patient's teeth are substantially off track.”),
- calculating with the control unit a second correction step (col 14 line 61 – col 15 line9 “a revised treatment plan can include a more direct "mid-course correction", in which the revised treatment plan includes a more direct path back toward the a planned arrangement of the initial treatment plan, as illustrated in FIG. 9B. While this approach may make use of the originally planned final arrangement, the more primary concern in this example type of correction is redirecting treatment back to the original treatment path, rather than from the actual position and more directly toward the original final position. In yet another embodiment, as illustrated in FIG. 9C, a revised treatment plan can include essentially "re-starting" treatment, and generating a new final arrangement of the teeth, for example, from segmenting and staging a new impression of the teeth, and directing the patient's teeth from the actual arrangement to the newly determined final arrangement of the teeth.”), taking into account the deviation between the actual state and target state of the body part to be corrected (Fig. 6, step 622), wherein the effect (Fig. 4 steps 314-316; col 8 lines 58-62, “Generating and/or analyzing digital treatment plans, as discussed herein, can include, for example, use of 3-dimensional orthodontic treatment planning tools such as ClinCheck from Align Technology, Inc. or other software available from eModels and OrthoCAD, among others.”; Fig. 10, storage subsystem 706). The revising the treatment plan, including the generation of revised models and/or target positions for dental appliances, is the second correction step. The generating, analyzing, displaying, of the model, including the path and final placement of teeth, via software is saving the effect on the medical aid, in the storage subsystem of the control unit.
Kitching does not teach the method for calculating a stimulus for the change of shape of a medical aid comprising: calculating with the control unit the stimulus that has to act on the medical aid to perform a second correction step
Kandil teaches an analogous method for calculating a stimulus for the change of shape of a medical aid (orthodontic correction rail 2) in order to change the shape of the aid from an actual position to a final target state (Abstract) comprising the steps: calculating with the control unit (“"Orthoanalyzer" from the company 3shape, taking into account the shape of the wire or wall and the wall thickness of the dynamic correction device, taking into account the actual position, the desired position and the shape change of the dynamic synthetic material during the correction process the above-described properties of the dynamic synthetic material, if necessary in conjunction with a static synthetic material. A software or an algorithm that performs this calculation is available, for example the software from Autodesk Inc., eg Cyborg Tool or VoxCad Simulator, which controls the 3D printers of, for example, Stratasys (Objet® or Connex series) in such a way that in good resolution the dynamic synthetic material”) the stimulus that has to act (“If the composition of the dynamic synthetic material or, alternatively, the proportion of the second polymer and its capacity for absorption of water and / or heat is known, the extent of the change in shape of the synthetic material produced by change of shape or volume is calculable.”; “In this material, contact with liquid and contact with heat, taken alone or in combination, causes a change in shape of the second polymer. For the dynamic correction splint, therefore, both the saliva of the oral cavity and the body temperature in the oral cavity trigger the segmental change in shape of the correction splint.”) on the medical aid to perform a second correction step (“The process according to the invention is carried out with a dynamic, synthetic material which, when water enters, changes its shape in a predictable manner. Such a material, typically a thermoplastic, is, for example, a hydrophilic acrylic monomer or oligomer. Often this material is combined with a static synthetic material. Typical are at least two different polymers, for example a hydrophobic acrylic monomer or oligomer as a static synthetic material and a dynamic synthetic one Material processed in combination, so that the static and the dynamic material abut each other, preferably in layers or sections, z. B. in the form of patches (English patches) abut each other. In this case, the first polymer does not respond to movement-inducing stimuli, while the second polymer reacts to movement-inducing stimuli, in particular by change in shape and / or volume. Motion-inducing stimuli may be the contact with moisture or liquid, in particular water and water-containing liquids, but also a solvent and heat and / or radiation.”; “To build the dynamic correction rail then the structure of the wall of the correction rail is calculated. The dynamic correction rail is produced in the actual state of the teeth. The wall construction is made up of first and second sections, for which the extent of movement under the influence of moisture and heat is known.”). The temperature and presence of liquid (e.g. saliva), having the effect of change in shape and/or volume, is the stimulus that has to act. The calculation of the necessary movement and/or change to the medical device for the desired effect, based off of the material and the temperature and presence of liquid, is the calculating the stimulus that has to act on the medical aid to perform the corrective step.
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kitching to include the calculation of stimulus of Kandil because it would yield predictable and advantageous results, including predicting the change in shape of the medical aid in response to the stimuli, thereby more accurately determining the change of body part on which the medical aid is applied.
Regarding claim 2, Kitching in view of Kandil teaches The method according to claim 1, wherein the stimulus is selected from the group consisting of the parameters time, temperature, pH value, current, radiation, sound, illumination, liquid and combinations of these parameters (Kandil: “Motion-inducing stimuli may be the contact with moisture or liquid, in particular water and water-containing liquids, but also a solvent and heat and / or radiation.”).
Regarding claim 3, Kitching in view of Kandil teaches The method according to claim 1, wherein the actual position of the body part to be corrected is detected with an impression, by digitally measuring the position of the body part, or by signals from a sensor that detects the position of the body part (Kitching: col 4 lines 15-21, “After the last appliance in the first set is administered to the patient, an image of the patient's teeth in their positions following administration of the first set of appliances can be taken (e.g., scan, impression, etc.). From the image of the patient's teeth in their current position, an assessment is made as to how the treatment is tracking relative to the original treatment projections.”, and lines 35-38, “bite matching techniques described herein can include matching teeth from the original image of the teeth or impression, to surface(s) of a new model of the teeth taken after treatment has begun.”). The scan, impression, and image are the impression, digital measurement, and/or signals from a sensor.
Regarding claim 4, Kitching in view of Kandil teaches The method according to claim 1, wherein the actual position of the body part to be corrected takes place by manual input into the control unit or by an input portal of the manufacturer of the medical aid or by an input portal of the attending physician (Kitching: Fig. 6, steps 608, 614, and 610, col 10 lines 60-65 “In Step 610, initial mismatch errors as identified above can be manually accounted for in the process. For example, a technician can manually adjust or reposition each tooth with a mismatch using the Previously Segmented Teeth Model or adjusts the information relating to each tooth with a mismatch (e.g., accounting for an extracted tooth).”; user interface input device 718). The manually adjust each tooth by a technician is the manual input, and the user interface input device is the input portal, wherein the technician includes the manufacturer and the attending physician.
Regarding claim 5, Kitching in view of Kandil teaches The method according to claim 1, wherein the control unit is connected (Kitching: col 15 lines 56-59 “It will be recognized that various components of the system can be, but need not necessarily be at the same physical location, but could be connected via various local-area or wide-area network media, transmission systems, etc.”) to a treatment device (Kitching: Fabrication system 722, dental appliances 723) , which is designed to cause the calculated stimulus to act on the medical aid (Kitching: Fig. 10, col 16 lines 3-5 “Fabrication system 722 fabricates dental appliances 723 based on a treatment plan, including data set information received from data processing system 700.”; Kandil: “Stratasys Inc. uses the synthetic materials described in US 2015/0158244 Ai and WO 2015/084422 Ai to practice a printing process described by Skylar Tibbits of the Self-Assembly Lab of the Massachusetts Institute of Technology MIT, Boston, USA, and to which Autodesk Inc. developed the software that allows synthetic material, in particular dynamic synthetic material, to be made into a product by means of a 3D printer, which then changes its external shape under the influence of motion-inducing and thus shape-changing stimuli.”).
Regarding claim 6, Kitching in view of Kandil teaches The method according to claim 1, wherein the control unit stores the temporal progression of the actual state of the body part to be corrected (Kitching: Figs. 9A-C; and Fig. 10, storage subsystem 706, file storages subsystem 714). The position of the teeth, compared to the expected treatment, at different times (t1, t2, etc.), is the stored temporal progression of the actual state of the body part to be corrected
Regarding claim 7, Kitching in view of Kandil teaches The method according to claim 1, wherein the control unit takes into account the temporal progression of the actual states of the body part to be corrected when calculating the stimulus for the second correction step (Kitching: Figs. 9A-C, “revised treatment” and “mid-course correction”; col 13 lines 32-38 “a treatment plan will include a prescribed timing for the planned tracking steps. The prescribed timing can include a specifically recommended date or may include a general increment of time (e.g., at treatment week 9, 10, 11, etc.), or can be based on the timing of other events of the treatment plan (e.g., after a patient wears a set of appliances).”; Kandil: “a series of dynamic correction devices is produced in which, after reaching a desired position of a first rail, a new actual position is detected and a second correction device is produced with a new desired position”, and “ Only after the action of saliva and / or body heat does the change in shape that is induced by the deformation or a change in volume of the first sections begin and only with the onset of the change in shape force is exerted on the teeth to be corrected, which thereby in the direction of the desired position to be moved. In this case, the width of canines, premolars and molars can be achieved by 3 mm with a single correction rail in a period of 9 to 12 weeks by the correction rail according to the invention.”).
Regarding claim 8, Kitching in view of Kandil teaches The method according to claim 1, wherein the control unit calculates, emits and stores (Kitching: Fig. 10, data processing system 700) the duration of the second correction step, the size of the next stimulus, and/or the parameters selected for the stimulation (Kitching: Figs. 9A-C col 13 lines 39-47 “Timing of progress tracking steps can be selected to occur based on a somewhat standardized treatment protocol or can be more particularly customized to an individual patient. More standardized protocols can take into account certain population statistics, generalized clinical expectations, and/or physiological parameters that can be used to generally predict rate of movement of a patient's teeth and the minimum length of treatment time necessary for the patient's teeth to progress off track if such progression is occurring.”, and lines 54-65 “Assuming a 2-week wear interval for each appliance, with a maximum tooth velocity of 0.25 mm/tooth per aligner, typically about 16 to 20 weeks of repositioning treatment (8 to 10 appliances) is required before movement of the teeth is substantial enough to detect a non-compliant or off track movement of the teeth, if such off track movement is occurring, though more drastic movements can produce off track movement after only a few weeks. As set forth above, timing of tracking measures can be selected based on the particular movement(s) prescribed and/or characteristics of the patient being treated and, therefore, are said to be customized to the particular patient.”). The timing of progress tracking steps (“phases” of said figures) is the duration of the correction step. The data processing system calculates (processors 702), emits (network interface 716, user interface input and output devices 718), and stores (storage subsystem 706) the data and processes, including the duration of the correction step.
Regarding claim 9, Kitching in view of Kandil teaches The method according to claim 1, wherein the duration of the second correction step emitted by the control unit (Kitching: Fig. 4 steps 310-316; col 8 lines 31-38 “The steps are defined and calculated so that each discrete position can follow by straight-line tooth movement or simple rotation from the tooth positions achieved by the preceding discrete step and so that the amount of repositioning required at each step involves an orthodontically optimal amount of force on the patient's dentition. As with other steps, this calculation step can include interactions with the clinician (Step 312).”; Figs. 9A-C), the size of the next stimulus, and/or the parameters selected for the stimulation are transferred manually to a treatment device (Kitching: Fig. 10, fabrication system 722, dental appliances 723) or wherein the control unit automatically uses the emitted duration of the second correction step (Kitching: col 8 lines 39-44 “ the process 300 can proceed to the manufacturing step (Step 316) in which appliances defined by the process are manufactured, or electronic or printed information is produced that can be used by a manual or automated process to define appliance configurations or changes to appliance configurations.”), the size of the next stimulus, and/or the parameters selected for the stimulation to control a treatment device. The steps of the treatment plan, including the “phases”, utilized in the process are the emitted duration of the correction step. The process of the data transferring to the fabrication machine to manufacture the dental appliances, and therefore control a treatment device, is performed manually or automatically.
Regarding claim 10, Kitching in view of Kandil teaches The method according to claim 1, wherein a separate data set is created for each medical aid (Kitching: col 4 lines 28-31 “The second set of appliances can be based on the initial treatment plan if treatment is progressing on track, or can be based on a revised or modified treatment plan where a determination is made that treatment is off track.”), which data set can be edited after entering an editing authorization (Kitching: col 8 lines 14-24 “At various stages of the process, the process can include interaction with a clinician responsible for the treatment of the patient (Step 312). Clinician interaction can be implemented using a client process programmed to receive tooth positions and models, as well as path information from a server computer or process in which other steps of process 300 are implemented. The client process is advantageously programmed to allow the clinician to display an animation of the positions and paths and to allow the clinician to reset the final positions of one or more of the teeth and to specify constraints to be applied to the segmented paths.”; lines 58-61 “Generating and/or analyzing digital treatment plans, as discussed herein, can include, for example, use of 3-dimensional orthodontic treatment planning tools such as ClinCheck from Align Technology, Inc.”). The modeling and tracking of the second set of appliances (and for each subsequent revision) is a separate data set is created for each medical aid. The interaction with a clinician responsible for the patient through a client process is the editing the data set. That the clinician is responsible for the patient and goes through a client process to reset final positions and specify constraints is the entering an editing authorization.
However, even if Kitching in view of Kandil does not explicitly recite entering an editing authorization, it does teach utilizing specific software for performing the action (ClinCheck from Align Technology, Inc.). As evidenced by Sesame (Invisalign settings, Sesame Communications Help Center (2015) https://www.sesamehelp.com/ortho-dental-sesame/invisalign-settings/, hereafter “Sesame”), said software requires a login to access data (“Sesame requires access to your Invisalign account in order to manage your patient ClinChecks , so it is essential that we have accurate account login information”), and therefore requires entering an editing authorization.
Regarding claim 11, Kitching in view of Kandil teaches A control unit for carrying out a method according to claim 1 (Kitching: Fig. 10, data processing system 700), connected to an input portal (user interface input device 718) for entering the actual state of the body part to be corrected (Kitching: Fig. 6, steps 608, 614, and 610, col 10 lines 60-65 “In Step 610, initial mismatch errors as identified above can be manually accounted for in the process. For example, a technician can manually adjust or reposition each tooth with a mismatch using the Previously Segmented Teeth Model or adjusts the information relating to each tooth with a mismatch (e.g., accounting for an extracted tooth).”). The manually adjust each tooth by a technician is the manual input, and the user interface input device is the input portal, wherein the technician includes the manufacturer and the attending physician.
and with means for calculating (Kitching: at least one processor 702) a stimulus for the change of shape of a medical aid (Kandil: “If the composition of the dynamic synthetic material or, alternatively, the proportion of the second polymer and its capacity for absorption of water and / or heat is known, the extent of the change in shape of the synthetic material produced by change of shape or volume is calculable.”) as well as with a storage device wherein the effect of the stimulus on the medical aid is saved in the control unit (Kitching: storage subsystem 706; Kandil: “Typical arrangements for the static and dynamic synthetic material for individual teeth or misalignments may be stored in a database for retrieval later in the construction of another correction device and integrated into a new correction device for one or more teeth.”), wherein the storage device of control unit is designed to store the temporal progression of the correction steps (Kitching: Figs. 9A-C; and Fig. 10, storage subsystem 706, file storages subsystem 714).
Regarding claim 12, Kitching in view of Kandil teaches The control unit according to claim 11, wherein the control unit and input portal are spatially separated, and wherein the data from the input portal are transferred to the control unit (col 15 lines 48-59 “One or more of the storage systems, drives, etc may be located at a remote location, such coupled via a server on a network or via the Internet's World Wide Web. In this context, the term "bus subsystem" is used generically so as to include any mechanism for letting the various components and subsystems communicate with each other as intended and can include a variety of suitable components/systems that would be known or recognized as suitable for use therein. It will be recognized that various components of the system can be, but need not necessarily be at the same physical location, but could be connected via various local-area or wide-area network media, transmission systems, etc.”). The components, being remote or not necessarily at the same physical location, are spatially separated. The communication between various components and subsystems (e.g. user interface 718 and processor(s) 702 and/or storage subsystem 706 via bus subsystem 704) is the data input being transferred to the control unit.
Regarding claim 13, Kitching in view of Kandil teaches The control unit according to claim 11, wherein the input portal is opened by means of an access authorization (Kitching: col 8 lines 14-24 “At various stages of the process, the process can include interaction with a clinician responsible for the treatment of the patient (Step 312). Clinician interaction can be implemented using a client process programmed to receive tooth positions and models, as well as path information from a server computer or process in which other steps of process 300 are implemented. The client process is advantageously programmed to allow the clinician to display an animation of the positions and paths and to allow the clinician to reset the final positions of one or more of the teeth and to specify constraints to be applied to the segmented paths.”; lines 58-61 “Generating and/or analyzing digital treatment plans, as discussed herein, can include, for example, use of 3-dimensional orthodontic treatment planning tools such as ClinCheck from Align Technology, Inc.”). The interaction with a clinician responsible for the patient through a client process is the opening the input portal by means of an access authorization. That the clinician is responsible for the patient and goes through a client process to reset final positions and specify constraints is an access authorization.
However, even if Kitching in view of Kandil does not explicitly recite means of an access authorization, it does teach utilizing specific software for performing the action (ClinCheck from Align Technology, Inc.). As evidenced by Sesame (Invisalign settings, Sesame Communications Help Center (2015) https://www.sesamehelp.com/ortho-dental-sesame/invisalign-settings/, hereafter “Sesame”), said software requires a login to access data (“Sesame requires access to your Invisalign account in order to manage your patient ClinChecks , so it is essential that we have accurate account login information”), and therefore requires a means of an access authorization.
Regarding claim 14, Kitching in view of Kandil teaches The method according to claim 1, further comprising applying the stimulus to the medical aid to change of shape of the medical aid in order to change the shape of the aid from an actual position to a final target state (Kandil: “A change in shape of the dynamic synthetic material caused by the action of motion-inducing stimuli causes the position of the wire to change, causing one or more teeth to move in the changed position. According to an advantageous embodiment of the invention known per se fixations are used by the dentist, while only the wire according to the invention in the actual position produced wire, which moves by move-inducing stimuli in the desired position”).
Regarding claim 15, Kitching in view of Kandil teaches The method according to claim 14, further comprising treating the body part with the medical aid in the final target state (Kitching: Figs. 2C; 3 steps 206 and 208; and 9A-C) .
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/B.B.G./Examiner, Art Unit 2863
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2863