Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 21 objected to because of the following informalities: On line 2 of the claim “the projected force vector” is believed to be in error for -the projected normal force vector-. 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.
Claims 1-8 and 10-21 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.
With respect to claims 1 and 20, the limitations including “projecting a normal force vector at each of a plurality of points of the at least one tooth onto a tangent vector of the movement trajectory at each respective one of the plurality of points to determine active surfaces” is unclear. It is unclear if the movement trajectory is for the entire tooth such that there is a single movement trajectory and all the points are a normal vector onto a tangent vector of that single movement trajectory or if the movement trajectory is a plurality of movement trajectories such that it is the movement trajectory of each point. It is noted that the applicant should amend the claim to clarify what is being claimed. It is noted that for examination purposes, the limitations are being interpreted as a single movement trajectory for the tooth and each point is a normal vector as claimed with respect to the singular movement trajectory. Further is unclear how the active surface is determined in view of the above rejection.
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.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. law of nature, a natural phenomenon, or an abstract idea) without significantly more. With Hilliard (6,702,575) provided as evidentiary support.
In determining patent subject matter eligibility under 35 U.S.C. 101 the U.S. Patent Office issued guidance on January 7, 2019 that was then updated in October 2019. That guidance has since been incorporated into the Ninth Edition, Revision R-07.2022 of the Manual of Patent Examination Procedure (MPEP), particularly Sections 2103 through 2106.07(c). The Step 1, Step 2A Prong One, Step 2A Prong Two, and Step 2B determinations set forth in the Patent Office guidance and MPEP are addressed below.
35 U.S.C. 101 - Step 1 - Determination as to whether claims are directed to a statutory category specified in 35 U.S.C. 101 (MPEP 2106.03) - Claim 20 directed to a "non-transitory computing device readable medium storing instructions executable by a processor to cause a computing device to perform a method" is interpreted as requiring a physical device ("a computing device readable medium") and determined to fall within the statutory category of a "machine" and/or [article of] "manufacture"
35 U.S.C. 101 - Step 2A Prong One - Determination as to whether the claims recite a Judicial Exception including an abstract idea, law of nature, or natural phenomenon (MPEP 2106.04). Claim 20, as a whole, is directed to the Judicial Exception (MPEP 2106.04) of an abstract idea (MPEP 2106.04(a)). The claimed invention is directed to a mental process - concepts that are capable of being performed in the human mind - including observations, evaluations and judgements (MPEP 2106.04(a)(2)). More particularly with respect to independent claim 20, the computer instruction method steps of "receiving a digital scan of a patient's teeth" may be performed mentally (e.g. an orthodontist receives/reviews a digital scan of the patient's teeth); "determining a plurality of treatment stages to incrementally reposition at least one tooth" may be performed mentally (e.g. an orthodontist mentally determines how a particular tooth that is out of alignment is to be repositioned through a plurality incremental steps from an initial position to a final position in which the tooth is moved into alignment); “projection a normal force vector at each of a plurality of points of the at least one tooth onto a tangent vector” (e.g. using mathematical equations such as finite element analysis), "determining a movement trajectory for at least one tooth" may be performed mentally (e.g. an orthodontist mentally determines a direction in which a tooth is to be moved to bring it into the desired alignment); "determining a plurality of contact points between the orthodontic aligner and a surface of at least one tooth" may be performed mentally (e.g. an orthodontist may mentally determine/envision contact points for an orthodontic aligner that contact an out of position tooth to push the tooth into the desired alignment); "determining individual trajectories from the first position to the second position for each of the plurality of contact points" may be performed mentally (e.g. an orthodontist mentally determines a direction in which a tooth is to be moved at the contact points to bring the tooth into the desired alignment); and "designing a geometry for the orthodontic aligner based at least in part on the individual trajectories" may be performed mentally (e.g. an orthodontist may mentally determine/envision the geometry for an orthodontic aligner based on the determined trajectories to contact an out of position tooth and push the tooth toward the desired alignment).
It is noted that orthodontists have long practiced their trade/art of moving and repositioning teeth into alignment - well before the advent of computers - and are most certainly capable of envisioning and mentally determining the directions in which the teeth are to be moved, the forces necessary to move the teeth into alignment, and the shapes and arrangements of orthodontic appliances necessary to accomplish such alignment. Attention is directed to Hilliard (US 6,702,575) who, for example, in a very similar process discloses that an orthodontist is to make numerous such observations and mental determinations regarding a patient's treatment with aligners and auxiliary devices without any use of a computer. More particularly, Hilliard discloses that "the aligner will be visually assessed by the doctor on a tooth-by tooth basis to identify the most mechanically-advantageous points at which to impinge corrective forces" (column 8, lines 44-52) after which point the doctor alters the shape of the aligner 20 by fixing an aligner auxiliary 30 to apply a particular force in a particular direction to misaligned tooth 10 (see Figures 1, 2, 2a; column 8, line 44-57). The orthodontist may further mentally determine how much force is necessary to apply through the selection different sizes (Figures 3a-3c) and hardness of projections (Figures 4a-4c) used to alter the shape of the aligner. Likewise, with the presently claimed invention, the claimed method includes steps that are capable of being performed as a mental process - concepts that are capable of being performed in the human mind - including observations, evaluations and judgements.
35 U.S.C. 101 - Step 2A Prong Two requires a determination as to whether the claims as a whole integrates the Judicial Exception into a Practical Application of that exception (MPEP 2106.04(d)). With regard to the requirement in claim 20 of a "non-transitory computing device readable medium storing instructions" amounts to an "additional element" beyond the abstract idea, it is noted that the performance of a mental process on a generic computer/computer readable medium fails to integrate the Judicial Exception into a Practical Application of the exception (see MPEP 2106.04(a)(2)(III)(C)). There is no disclosure that the method steps/computer instructions on the computer readable medium improve the manner in which the computer (or computer readable medium) operates (see MPEP 2106.04(d)(1)). The claims do not go beyond generally linking the judicial exception to a computer environment. The claims do not require that the method be implemented by a particular machine (see MPEP 2106.05(b)), nor do the claims require the method to particularly transform a particular article (see MPEP2106.05(c)). The claims as whole fail to integrate the abstract idea (the "judicial exception") into a practical application of that abstract idea.
Claim 20 is directed solely to a digital virtual environment where data is input ("receiving") and processed ("determining"; "designing") - there are no additional elements integrating the judicial exception into a practical solution - the method is not used to operate a manufacturing device, the method is not used to improve the functioning of a computer, the method is not used to transform a particular article into a different state or thing - there is no meaningful limitation beyond generally linking the use of the judicial exception to a particular technological environment. 35 U.S.C. 101 - Step 2B requires a determination as to whether the claims amount to Significantly More than the Judicial Exception (MPEP 2106.05). As set forth above with respect to Step 2A Pong One the claimed "non-transitory computing device readable medium" of claim 20 is capable of being performed mentally and represent nothing more than concepts related to performing observations, evaluations and judgements which fall within the judicial exception. The "non-transitory computing device readable medium" of claim 20 requires at most a generic general purpose computer memory. There is no disclosure in the written description that the computer memory device is anything more than a generic component, nor is there any disclosure that the instructions improve the manner in which the computer device operates. Paragraph [00217] states that the data storage device includes "by way of example semiconductor memory devices, such as EPROM, EEPROM, and flash memory devices; magnetic disks such as internal hard disks and removable disks; magneto-optical disks; and CD- ROM disks" and that "suitable processors include, by way of example, both general and special purpose microprocessors." The mere recitation in the claims of a generic conventional computer memory that is intended to be used in a conventional manner to perform conventional computer functions that are well understood and routine does not amount to "significantly more" than the judicial exception. The claims do not go beyond inputting ("receiving"), and processing ("determining") data with a standard generic computer.
The analysis of data in a particular field and the stating those functions in general terms, without limiting them to technical means for performing the functions is an abstract idea and does not meet the requirements of 35 U.S.C. 101. The claims do not require that the method be implemented by a particular machine and they do not require that the method particularly transform a particular article. The claims set forth a process of presenting information of a specific content and are not directed to any particularly asserted inventive technology for performing those functions. Nothing in the claims or specification requires anything more than a conventional prior art computer for analyzing numbers according to a mathematical algorithm. The claimed system and method fall with the judicial exception to patent eligible subject matter of an abstract idea without significantly more. See Elec. Power Grp., LLC V. Alstom S.A., 119 USPQ2d 1739 (Fed. Cir. 2016) for further guidance.
Claim Rejections - 35 USC § 103
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.
Claims 1-8 and 10-21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon (2006/0223022).
With respect to claim 1, Solomon teaches a method for designing an orthodontic alinger, the method comprising determining as part of an orthodontic treatment plan, a plurality of treatment stages to incrementally reposition at least one tooth of a patient’s dentition from an initial position to a target position (par. 6, 15, 28), determining, for one of the plurality of treatment stages, a movement trajectory for the at least one tooth from a first position to a second position for a stage of the plurality of treatment stages of the orthodontic treatment plan (see figs. 10a-10b, such that it rotates the tooth from a first position to a second planned position, claim 1), after determining the plurality of treatment stages, projection a normal force vector at each of a plurality of points of the at least one tooth onto a tangent vector of the movement trajectory at each respective one of the plurality of points to determine active surfaces on the at least one tooth at each of the plurality of points on the tooth surface, that active surface comprising regions onto which force may be applied by the orthodontic alinger to move the at least one tooth along the determined movement trajectory (see pars. 74-75, figs. 10-10b, annaoted figure below). Such that Solomon teaches the points where elements 17/16 being the determined active surfaces. Such that the trajectory of the tooth movement is a rotational movement around the axis 7A of the tooth (see annotated figure below), such that a tangent vector of the movement trajectory would be a vector in the direction of vector 6a and a vector normal to that would be 6b. It is noted that the active surfaces are the surfaces of the tooth in which the elements 16/17 contact the tooth. Solomon further teaches determining a plurality of contact points between the orthodontic alinger and a surface of the at least one tooth of the patient’s dentition for a stage of the plurality of treatment stages, after determining the movement trajectory, wherein the plurality of contact points are located at the active surfaces (see figs. 10-10b, pars. 74-75, such that the contact points are the points of elements 16/17 that contact the tooth at the active surfaces, see further abstract, pars. 61, 77-78), determining individual trajectories from the first position to the second position for each of the plurality of contact points, after determining the plurality of contact points (pars. 28-29, 61, 70, 74-75, 77-78, such that the contract points are the active surfaces), designing a geometry for the orthodontic alinger based on at least in part of the individual trajectories determined for each of the plurality of contact points and manufacturing a physical orthodontic alinger (pars. 74-75, 77, see claim 1, such that an appliance is provided, therefore the digitally designed appliance is manufactured). Solomon teaches the limitations of claim 1 as discussed above in detail, however, does not specifically teach the first step of "receiving a digital scan of a patient's dentition." Solomon suggests at least in paragraphs [0006], [0010] the use of an initial data set representing the patient's teeth and computer aided finite element analysis for predicting tooth movement (e.g. paragraphs [0015], [0078]) in order to create an appliance "with a specific level of force, range and direction, in exact locations determined by the desired movement" (paragraph [0081]), but does not appear to explicitly disclose the step of receiving a digital scan in order to provide the initial data set of the patient's teeth. One of ordinary skill in the art, at the time of applicant's invention, would have found obvious as matter of routine to have obtained such initial data from a digital scan of a patient's dentition.
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With respect to claim 2, Soloman further teaches where at least one of the plurality of contact points corresponds to a ridge, protrusion, or dimple on the orthodontic alinger (see figs. 10-10, such that elements 16/17 are a protrusion, since they are protruding towards the tooth, and correspond to the contact points).
With respect to claim 3, Soloman further teaches wherein designing the geometry of the orthodontic aligner comprises incorporating a ridge, protrusion, or dimple into the geometry of the orthodontic alinger (see figs. 10a-10b, such that protrusions 16/17 are incorporated into the alinger).
With respect to claim 4, Soloman further teaches wherein the ridge, protrusion, or dimple is incorporated at one of the plurality of contact points to modify a corresponding individual trajectory of the one of the plurality of contact points (see pars. 62, 74-75, 77-78, such that individual trajectory of the contact point is modified relative to the overall trajectory of the tooth).
With respect to claim 5, Soloman further teaches wherein at least one of the plurality of contact points correspond to a crown point on the at least one tooth of the patient’s dentition (see figs. 10a-10c, such that the contact points are located towards the crown end, i.e. crown point of the tooth).
With respect to claim 6, Soloman further teaches determining a force system for moving the at least one tooth from the first position to the second position (see pars. 29-33, 62, 77-78).
With respect to claim 7, Soloman further teaches wherein the geometry of the orthodontic alinger is designed such that contact between the orthodontic alinger and the surface of the at least one tooth of the patient’s dentition at the plurality of contact points provides the determined force system (see pars. 29-33, 62, 74-75, 77-78).
With respect to claim 8, Soloman further teaches wherein the geometry of the orthodontic alinger is designed to reduce friction between an inner surface of the orthodontic alinger and the surface of that least one tooth of the patient’s dentition (see figs. 10a-10b, such that friction is reduced relative to an alinger without the envelope of freedom).
With respect to claim 10, Soloman further teaches wherein determining active surfaces further comprises identifying surfaces with desirable orientations for imparting a force system for moving the at least one tooth from the first position to the second position (see pars. 61-62, such that the specific location is the desirable orientation).
With respect to claim 11, Soloman further teaches determining resistive surface on the at least one tooth of the patient’s dentition (pars. 32, 78, such that the center of resistance of the tooth is considered).
With respect to claim 12, Soloman further teaches considering the active surface and resistive surfaces when designing the force system of the alinger to move the at least one tooth form the first position to the second position including analysis in determining the points of contact with the aligner includes, a center's of resistance and rotation based on root length, surface area, root shape, bone height (paragraph [0032]). Soloman further teaches unfavorable forces in prior art system being delivered to teeth (par. 59) and providing the alinger with a functional force to deliver the planned movements (see pars. 23-24). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filling date of the invention to modify Soloman to include the step of comparing the ratio to a predefined threshold as claimed in order to ensure that a functional force is being delivered to the at least one tooth to move the at least one tooth to the planned second position from the first position.
With respect to claim 13, Soloman does not specifically teach the method including determining the plurality of contact points comprises assessing which areas of the surface of the at least one tooth are accessible intraorally, however, Soloman teaches the contact points being on exposed surfaces of the at least one tooth are accessible, such that they can be contact with alinger. Therefore, it would have been obvious to one having ordinary skill in the at before the effective filling date of the invention that Soloman obviously determines that the contact points are accessible.
With respect to claim 14, Soloman further teaches tracking movement of the plurality of contact points throughout the orthodontic treatment plan (see fig. 10b, par. 75, such that different aligners in the series have different contact points to contact the different modifiers 18, such that the contact points are tracked since the first shell contact the first modifier and the second shell contact the next modifier).
With respect to claim 15, to the limited extent that variations in thickness would not be inherent in the Solomon appliance. Then one of ordinary skill in the art would have found it obvious to have provide for varied thickness to allow for areas of different flexibility.
With respect to claim 16, Soloman further teaches comprising determining whether a dental attachment 18 is needed to impart a force system for moving the at least one tooth along the movement trajectory form the first position to the second position (see par. 75).
With respect to claim 17, Soloman further teaches contouring a model of a tooth surface of the at least one tooth to improve an amount of surface for receiving a force system for moving the at least one tooth from the first position to the second position (pars. 15, 75, such that the vector modifier is added to the tooth to contour the model of the tooth, such that it teaches using computer aided finite element analysis).
With respect to claims 18-19, Soloman teaches digitally designing the alinger and then obviously manufacturing it, however, is silent as to the method of manufacturing it. It is noted that it would have been obvious to one having ordinary skill in the art to use any well-known manufacturing method including pressure fitting and stereolithography to manufacture the claimed alinger.
With respect to claim 20, Solomon teaches the method of claim 1 being carried out on a computer (see detailed rejection above), therefore, providing the instructions in a computer readable medium for performing the Solomon method of designing an orthodontic appliance would have been obvious to one of ordinary skill in the art, particularly in light of Solomon's use of a computer to determine the points of contact (paragraph [0032]) and the disclosed prior art methods of computer design of orthodontic appliances (paragraph [0006]).
With respect to claim 21, Solomon teaches providing the alinger with a functional force to deliver the planned movements (see pars. 23-24), therefore, it would have been obvious to one having ordinary skill in the art determine the active surfaces by selecting point for which the projected force vector exceeds a predefined threshold (i.e. a threshold large enough to deliver the desired functional force).
Response to Arguments
Applicant's arguments filed July 6, 2026 have been fully considered but they are not persuasive.
The applicant argues that claim 20 cannot be performed mentally due to the added limitations including projection of a normal force vector. However, it is noted that the projection of a vector as claimed is using known mathematical relations and can be carried out mentally. While it may not be practical to be carried out mentally, the claimed method is capable of being carried out mentally and therefore, the 101 rejection is proper and maintained.
The applicant further argues that the prior art of Solomon does not teaches the claimed limitations directed towards the vectors. However, as discussed above in detail, the embodiment of figures 10a-10b read on the claimed limitations. Such that the movement trajectory is a rotational movement and a normal force vector at each of a plurality of points (where elements 16/17 are placed) is projected onto a tangent vector of the movement trajectory as illustrated above in detail in the annotated figure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art of Chishti which teaches SLA and vacuum forming are well known method of manufacturing dental aligners (see par. 199).
The prior rat of Phan teaching that varying the thickness of the alinger changes the stiffness/elastic modulus of the alinger which would change the force delivered to the tooth/teeth (see pars. 15-16).
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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/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
10/1/2026
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