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
Claims 1 and 4-15 are pending. Claims 2-3 have been canceled. Claims 1, 13, and 15 have been amended. The rejections are revised in view of Applicant’s amendments.
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 13-15 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea involving a mental step without significantly more. Claim 13 recites, “obtain a 3D model of a dentition of the individual; determine an insertion direction for the dentition; determine, automatically by the processor using the 3D model, a height of contour of one or more teeth of the dentition based on the insertion direction; identify a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition.” These limitations recite a mental step of designing the 3D shape of a dental splint based on a model of an individual’s dentition, the insertion direction, a chosen height of contour, and reaching to a chosen cut line which is the end point of the splint in that direction. The recitation of applying the judicial exception in a general computer (i.e. processor using the digital 3D model) does not place the judicial exception into practical application. Claim 13 recites computing components (storage device and a processor). The recitation of applying the judicial exception in a general computer (i.e. storage device and processor or processor using the digital 3D model) does not place the judicial exception into practical application. A general recitation that “the system is configured to fabricate the dental splint using additive manufacturing” does not require the actual fabrication. In any event, the link is to the general category of additive manufacturing. The abstract idea is not integrated into a practical application and does not recite significantly more than the abstract idea. Claim 13 recites computing components (storage device and a processor) performing the method steps of claim 1. The recitation of applying the judicial exception in a general computer (i.e. storage device and processor or processor using the digital 3D model) does not place the judicial exception into practical application because it does not further limit the abstract idea beyond the technological field of additive manufacturing to a particular application.
Claim 14 recites a component for a generic category of manufacturing, additive manufacturing, and links the judicial exception to a technological field. Claim 14 does not further limit the abstract idea beyond the technological field of additive manufacturing to a particular application.
Claim 15 recites the similar limitations as claim 13 but embodied in a computer-readable storage medium. The recitation of applying the judicial exception in a general computer (embodied in a computer-readable storage medium) does not place the judicial exception into a practical application. Nor does adding the additional mental step of generating the layer-wise build instructions. For the reasons discussed above regarding claim 13, the limitations of claim 15 do not amount to significantly more. The recitation of applying the judicial exception in a general computer (i.e. processor using the digital 3D model) does not place the judicial exception into practical application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-9 and 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wouters (US 2015/0245890) in view of Kuo (US 2014/0142897).
Regarding claim 1, Wouters discloses a method for designing a dental splint for an individual ([0001]), comprising: obtaining a digital 3D model of a dentition of the individual (3D surface data of the patient’s oral situation, [0064] [0076]); determining an insertion direction for the dentition (as shown in Figs. 6a-b, the insertion direction is normal to an occlusal plane of the dentition); determining, automatically by a processor using the digital 3D model, a height of contour for one or more teeth of the dentition based on the insertion direction (distance map shown in Fig. 2b includes height of contour for one or more teeth based on the insertion direction and discussed in [0066] as fitting the oral situation; processing is digital [0008]); and fabricating the dental splint ([0114]), wherein the fabricated dental splint has an extent at the cut line (apical edge 330 in Fig. 6a, [0075-84]) cut line is interpreted based on [0015-16] of applicant’s disclosure as where the edge of the dental split extends) wherein the dental splint is fabricated using additive manufacturing ([0114]).
Wouters teaches a method substantially as claimed. Woulters teaches identifying a cut line of the dental splint with an apical edge, but does not specify how this relates to the height of contour (second value is the apical edge, see apical edge 330 in Fig. 6a, [0066] [0075-84]).
Wouters does not disclose identifying a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition.
However, in the same field of endeavor of modeling and manufacturing dental appliances based on digital scans of a patient’s dentition, [0025-27], Kuo teaches identifying a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition (virtually filling in undercut area within a threshold distance from the height of contour to ensure adequate retention, [0021]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wouters such that the apical edge 330 extends a distance apically beyond the height of contour of the one or more teeth of the dentition because [0004] and [0021] of Kuo teaches that doing so ensures adequate retention while avoiding great discomfort and/or distortion upon insertion.
Regarding claim 4, Wouters as modified teaches wherein the dental splint is cut at the cut line (alternatively milled [0114]).
Regarding claim 5, Wouters as modified teaches wherein the insertion direction is normal to an occlusal plane of the dentition (as shown in Figs. 6a-b, the insertion direction is normal to an occlusal plane of the dentition).
Regarding claim 6, Wouters as modified teaches wherein the insertion direction is parallel to the teeth of the dentition (as shown in Figs. 6a-b, the insertion direction is normal to an occlusal plane of the dentition and therefore parallel to the teeth which extend normal to an occlusal plane).
Regarding claim 7, Wouters as modified teaches wherein the height of contour is determined on a lingual side of the dentition (in building the model, based on patient’s oral situation from lingual side, [0057]).
Regarding claim 8, Wouters as modified teaches wherein the height of contour is determined on a facial side of the dentition (in building the model, based on patient’s oral situation from buccal (facial) side, [0057]).
Regarding claim 9, Wouters as modified teaches wherein the retention amount is pre-determined based on a selected dental splint material (with no limitation tied to the specific material, any retention for any material is within the scope of the claim, as modified, [0021] of Kuo teaches a threshold distance, with ordinary optimization to ensure it is sufficient and not excessive, [0004] [0021]).
Regarding claim 11, Wouters as modified teaches wherein the cut line is identified automatically (apical edge 330 of cut off line automatically determined, [0083], as modified in view of Kuo as per claim 1).
Regarding claim 12, Wouters as modified teaches wherein the cut line is identified by a user (any variation due to a choice by a user would be a design choice by that user and is encompassed by further refining of specific features, see MPEP 2144.04(VI)(C), [0073] [0083]; additionally, as modified, [0004] of Kuo teaches testing for comfort and making adjustments).
Regarding claim 13, Wouters discloses a system for designing a dental splint for an individual ([0001]), comprising: a storage device (a digital model is inherently stored somewhere, [0060]); a processor in electronic communication with the storage device (digital processing, particularly with a moving average model, entails a processor in electronic communication with wherever the digital data is stored, [0078-81]), wherein the processor is configured to: obtain a 3D model of a dentition of the individual (3D surface data of the patient’s oral situation, [0064] [0076]); determine an insertion direction for the dentition (as shown in Figs. 6a-b, the insertion direction is normal to an occlusal plane of the dentition); determine, automatically by a processor using the digital 3D model, a height of contour of one or more teeth of the dentition based on the insertion direction (distance map shown in Fig. 2b includes height of contour for one or more teeth based on the insertion direction and discussed in [0066] as fitting the oral situation; processing is digital, [0008]).
Wouters teaches a method substantially as claimed. Woulters teaches identify a cut line of the dental splint with an apical edge, but does not specify how this relates to the height of contour (second value is the apical edge, see apical edge 330 in Fig. 6a, [0066] [0075-84]).
Wouters does not disclose identify a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition.
However, in the same field of endeavor of modeling and manufacturing dental appliances based on digital scans of a patient’s dentition, [0025-27], Kuo teaches identify a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition (virtually filling in undercut area within a threshold distance from the height of contour to ensure adequate retention, [0021]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wouters such that the apical edge 330 extends a distance apically beyond the height of contour of the one or more teeth of the dentition because [0004] and [0021] of Kuo teaches that doing so ensures adequate retention while avoiding great discomfort and/or distortion upon insertion.
Regarding claim 14, Wouters as modified teaches further comprising a 3D printer in electronic communication with the processor ([0114]).
Regarding claim 15, Wouters discloses a non-transitory computer-readable storage medium having stored thereon processor-executable instructions configured to cause a processor to perform operations (digital processing entails stored processing instructions, [0078-81]) comprising: obtaining a digital 3D model of a dentition of the individual (3D surface data of the patient’s oral situation, [0064] [0076]); determining an insertion direction for the dentition (as shown in Figs. 6a-b, the insertion direction is normal to an occlusal plane of the dentition); determining, automatically by a processor using the digital 3D model, a height of contour for one or more teeth of the dentition based on the insertion direction (distance map shown in Fig. 2b includes height of contour for one or more teeth based on the insertion direction and discussed in [0066] as fitting the oral situation; processing is digital, [0008]).
Wouters teaches a method substantially as claimed. Woulters teaches identifying a cut line of the dental splint with an apical edge, but does not specify how this relates to the height of contour (second value is the apical edge, see apical edge 330 in Fig. 6a, [0066] [0075-84]).
Wouters does not disclose identifying a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition.
However, in the same field of endeavor of modeling and manufacturing dental appliances based on digital scans of a patient’s dentition, [0025-27], Kuo teaches identifying a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition (virtually filling in undercut area within a threshold distance from the height of contour to ensure adequate retention, [0021]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Wouters such that the apical edge 330 extends a distance apically beyond the height of contour of the one or more teeth of the dentition because [0004] and [0021] of Kuo teaches that doing so ensures adequate retention while avoiding great discomfort and/or distortion upon insertion.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wouters (US 2015/0245890) in view of Kuo (US 2014/0142897) as applied to claim 9 above, and optionally further in view of Steingart (US 2012/0179281).
Regarding claim 10, Wouters teaches wherein the retention amount is between 0.25 mm and 0.35 mm, inclusive, for nylon (as modified, [0021] of Kuo teaches a threshold distance, with ordinary optimization to ensure it is sufficient and not excessive, [0004] [0021] and would be subject to routine experimentation, see MPEP 2144.05; Kuo [0061] teaches a polymeric material but is silent as to which ones.).
The teachings of Wouters in view of Kuo are independent of the particular material, ordinary optimization would be followed for other materials. In anticipation of any objections that Nylon was not taught, further reference is made to Steingart, which is the same field of endeavor of scanning patient teeth, modeling dental appliances, and fabricating said dental appliances ([0022] [0029]). Steingart teaches wherein the selected dental splint material is nylon ([0013]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Wouters in view of Kuo for the selected material to be Nylon because Wouters is not explicit as to the material, [0061] of Kuo teaches a polymeric material, and [0013] of Steingart teaches that Nylon (along with two other polymeric materials) are appropriate materials for a permanent dental appliance. As modified, using Nylon and following the teachings of [0004] [0021] of Kuo, a threshold distance would be subject to the ordinary optimization, and thereby result in the recited range.
Response to Arguments
Applicant's arguments filed January 12, 2026 regarding the rejection under 35 USC 101 have been fully considered but they are only partly persuasive.
Applicant is correct that incorporating claim 3 into claim 1 renders the claim patent eligible. However, all of the limitations that made claim 3 eligible have not been incorporated into claims 13-15. Accordingly, the rejection is maintained as to claims 13-15.
Applicant's arguments filed January 12, 2026 have been fully considered but they are not persuasive.
Applicant argues that Kuo does not teach “identifying a cut line of the dental splint based on a retention amount as a distance apically beyond the height of contour of the one or more teeth of the dentition.” Applicant’s arguments go to differences in how the process is explained. Nevertheless, [0021] of Kuo, by teaching virtually filling in undercut area within a threshold distance from the height of contour to ensure adequate retention, teaches an area of the dental split extending a distance apically beyond the height of contour. Accordingly, the limitation is reached. Applicant’s second argument is derivative of the first and is similarly unpersuasive.
Applicant’s 3rd and 4th arguments assert that Wouters teaches away and that the modification would require re-engineering Wouter’s cut-off determination, which would not be a simple substitution. This argument is not persuasive because the modification is not justified as simple substitution, but because [0004] and [0021] of Kuo teaches that doing so ensures adequate retention while avoiding great discomfort and/or distortion upon insertion. Wouters teaches challenges, but does not suggest that Kuo’s teachings of adequate retention while avoiding great discomfort and/or distortion upon insertion would be bad or could not be met.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J CHIDIAC whose telephone number is (571)272-6131. The examiner can normally be reached 8:30 AM - 6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sam Xiao Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS J CHIDIAC/ Examiner, Art Unit 1744
/XIAO S ZHAO/ Supervisory Patent Examiner, Art Unit 1744