Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Acknowledgment of Request for Continued Examination (RCE)
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 19, 2026 has been entered.
Rejections based 35 U.S.C. 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., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. With Hilliard (US 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); “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.
In response to the present rejection, applicant asserts that “the rejection does not show how the claimed subject matter is capable of being performed in the human mind” and that “the rejection provides conclusory statements with respect to many of the claim elements.” The examiner is not persuaded. The Office action explicitly points to a prior art reference Hilliard (US 6,702,575) as evidence that similar such determinations may commonly be performed in the human mind without the aid of a computer. Moreover, the examiner notes that the computer steps set forth in the claimed “computing device readable medium” are set forth very broadly and at a very high level with no details as to how the steps are performed, how the number of treatment stages is determined, how the movement trajectories are determined, how the contact points are determined, how the trajectories are determined or the precision required in making any of the determination. Such high level broadly set forth method steps further support the human mental capabilities determination.
Rejections based on Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-31 of U.S. Patent No. 8,439,672;
claims 1-30 of U.S. Patent No 11,529,215; and
claims 1-10 of U.S. Patent No 11,571,277.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims of ‘672, ‘215 and ‘277 set forth all of the elements of the presently claimed method. For example with regard to pending claim 1, the claims of ‘672 teach the determination of a plurality of treatment stages (claims 28-31); the determination of movement trajectories for the teeth (“movement vector” claims 1, 16); the determination of contact points (claim 2); the determination of individual trajectories (“movement vector” claims 1, 3, 9, 16); and designing a geometry for the orthodontic aligner (“outputting . . . data for generating an orthodontic appliance” claim 1; “designing . . . an appliance” claim 16). In regard to the “receiving a digital scan” limitation of pending claim 1, one of ordinary skill in the art would have found it obvious to have provided data from a digital scan for the “digital data” of patented claim 1. Likewise, the patented claims of ‘215 and ‘277 even more closely track the pending claims setting forth the scanning, determining a plurality of treatment stages, determining a movement trajectory (“movement vector”), determining contact points (configuring attachment device; trajectories of points), determining individual trajectories and designing the geometry of an orthodontic appliance. The present claims do not set forth any additional method steps not previously claimed in applicant’s earlier ‘672, ‘215 or ‘277 patents. One of ordinary skill in the art would have found the variations in which the method is presently claimed from that previously patented in the claims of ‘672, ‘215 or ‘277 to have been obvious.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,107,722. Although the claim at issue is not identical, it is not patentably distinct from the patented claims of ‘722. The previously patented claims set forth all of the elements of the presently claimed system including providing a non-transitory computing device readable medium (data storage unit/processing unit claim 1) with instructions to determine a plurality of treatment stages (“first” and “second” positions in a “treatment plan”, claim 1); determining a movement trajectory (“movement vector” claim 1); determining contact points (“determine a position of the one or more attachment devices” claim 3); determine individual trajectories (“movement vector” claims 1 and 3); and design a geometry of an orthodontic aligner (“determine geometry” claim 1). In regard to the “receiving a digital scan” limitation of pending claim 20, one of ordinary skill in the art would have found it obvious to have provided data from a digital scan for the “data” of patented claim 1. The present claims do not set forth any additional elements not previously claimed in applicant’s earlier ‘672 patent. One of ordinary skill in the art would have found the variations in which the method is presently claimed from that previously patented in the claims of ‘672 to have been obvious.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/015,314. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims of ‘314 set forth and teach each of the elements of the presently claimed invention. The present claims do not set forth any additional elements not also claimed in applicant’s pending ‘314 application. One of ordinary skill in the art would have found the variations in which the method is presently claimed from that currently set forth in the claims of ‘314 to have been obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Rejections based on Prior Art
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 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 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Solomon (US 2006/0223022).
Solomon discloses a method for designing an orthodontic aligner wherein an orthodontic treatment plan is (A) determined that includes a plurality of treatment stages to incrementally reposition at least one tooth from an initial position to a target position (note paragraph [0006] discussing initial, intermediate and final tooth arrangements and paragraph [0015] disclosing the use of a series of preprogrammed polymeric shells to provide for the movement of teeth into the desired alignment); (B) for at least one the patient’s teeth in one of the treatment stages a movement trajectory 7 (Figures 7A, 7B) is determined to move at least one tooth from a first position (Figure 7A) to a second position (Figure 7B); (C) a plurality of contact points between the orthodontic aligner and tooth surface are determined (note particularly 17 in Figure 6B; 16, 17 in Figure 7B; and 16, 17 in Figure 8B); (D) individual trajectories from the first position to the second position for each of the contact points are determined (note particularly 6, 7 in Figure 7B and 6a in Figure 8B); and (E) a orthodontic aligner 14 geometry is designed based at least in part on the individual trajectories for each of the plurality of contact points. Solomon clearly meets all of the limitations of claim 1, with the exception of the first step “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.
In response to the present rejection applicant argues that the arrows 6 and 7 in Solomon “show the direction of forces and not the trajectory for a point on the tooth” and that the claimed “determining individual trajectories from the first position to the second position for each of the plurality of contact points” is not taught by Solomon. The examiner is not persuaded. One practicing the Solomon invention would clearly and reasonably understand (and/or find obvious) that the teeth are not just pushed in some random direction in the hope that they will be moved into the desired position, but rather that the direction/”trajectory” of movement must first be determined and then point of contact and direction/trajectory of force necessary to push the tooth in that direction. Applicant further argues that Solomon fails to teach that the movement trajectory for at least one tooth in one of the treatment stages be determined “after determining the plurality of treatment stages” and argues that Solomon does not disclose the claimed feature. The examiner is not persuaded, it would have been obvious, if not implicit, in the Solomon method that that the movement trajectories at each stage (of the multiple Solomon stages – paragraphs [0006], [0015]) is dependent on the number of stages that are determined in the treatment plan. More particularly, if two successive appliances are determined to move a tooth from A to B, then a bigger trajectory is needed than if it is determined that three or more successive appliances are to be used. Likewise, it follows that it would have been obvious, if not implicit, that the number and locations of contact points would be determined after it is determined which direction/trajectory the tooth is to be moved. Determining the contact points before one determined which direction they wanted to move the tooth, would make no sense. Finally, it would have been obvious, if not implicit that one would determine the individual trajectories of the after it is determined where it is possible to contact the tooth – the contact points.
In regard to claims 2-4, note protrusions 16, 17 in Solomon. In regard to claim 5, note contact point 17 in Figure 7B of Solomon. In regard to claims 6, 7 and 9-11, note paragraph [0081] of Solomon (“with a specific level of force, range and direction, in exact locations determined by the desired movement”). In regard to claim 8, note envelope/free space 15 in Solomon to reduce friction. In regard to claims 11 and 12, the Solomon computer aided analysis in determining the points of contact with the aligner includes, includes a center’s of resistance and rotation based on root length, surface area, root shape, bone height (paragraph [0032]), taking into account a ratio of the resistive surface (e.g. root surfaces) to active surfaces for helping to determine the points of contact would have been obvious to one ordinary skill in the art. In regard to claims 13 and 14, selecting accessible points of contact and monitoring the progression of treatment would have been obvious to one of ordinary skill in the art as a matter of routine practice. In regard to claim 15, to the limited extent that variations in thickness would not be inherent in the Solomon appliance. Then one f ordinary skill in the art would have found it obvious to have provide for varied thickness in order to allow for areas of different flexibility. In regard to claim 18, note the dental attachment 18 in Figure 10C of Solomon. In regard to claims 18 and 18, the manufacture of the Solomon appliance by old and well-known processes would have been obvious to one of ordinary skill in the art. Finally, in regard to claim 20, 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]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ralph Lewis whose telephone number is (571) 272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Edelmira Bosques 571 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712