DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/21/25 has been entered.
The previous rejection under 35 USC 101 have been overcome by Applicant’s amendments as the claims now require fabricating the appliance and outer component.
Terminal Disclaimer
The terminal disclaimer filed on 11/20/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 10265141 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendment.
The Examiner notes that in order to move the application to allowance, the Examiner suggests amending the independent claims to recite that the orthodontic appliance applies tooth moving forces on the teeth alone (e.g. without the outer component) as recited in claim 1 of US 10265141 (“when worn while producing the same movement of the patient’s teeth by the appliance as would be produced by the inner appliance alone”). The inner component of Schultz does not apply orthodontic forces to the teeth without the outer component applied thereto.
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 2-20 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.
Regarding claims 2 and 12, the term “shaping the attachable outer component based on the determined geometry” is indefinite as it is unclear what, specifically, the step of shaping imparts on the claims. As best understood by the Examiner, a geometry of an object inherently provides its shape. It is unclear if Applicant intends for the term to impart any further structure to the claim or any further steps to the method; it is unclear therefore what is specifically required or not required by the claim and what the difference is between the “determining” and “shaping” steps. Clarification is required.
Regarding claims 7 and 17, the term “using a template of one or more predetermined dental arrangements” is indefinite as it is unclear what specifically the template comprises. Still further, as best understood by the Examiner, as discussed in the original disclosure, a template is a generic stored model, however the independent claims previously recite that the target arrangement, which is used to form the outer component, is based on a customized plurality of treatment stages from the 3D scan of the patient’s teeth, and therefore, not a template. Finally, it is unclear how a plurality of arrangements are used to form a single template. Clarification is required.
All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-3, 5-13, and 15-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schultz (US 2006/0093983 A1) in view of Phan et al (US 2002/0192617 A1) in view of Wen (US 2006/0093982 A1).
Regarding claims 2 and 12, Schultz discloses a method of fabricating an orthodontic appliance and an attachable outer component (see [0011]-[0012], [0017][0019] and [0022]), and a system for fabricating an orthodontic appliance and an attachable outer component, the system comprising one or more processors and memory operably coupled to the one or more processors and storing instructions that, when executed by the one or more processors, cause the system to perform operations comprising (e.g. computer which receives and analyses the digital data for design and manufacture of the appliance as cited below); the method/operations comprising: receiving digital data of a patient's teeth in an initial arrangement, wherein the digital data comprises a 3D dental scan (see [0022]); determining a plurality of treatment stages for incrementally repositioning the patient's teeth from the initial arrangement towards a target arrangement (e.g. stages correspond to times where different outer shells are used, see [0016]); determining a geometry for the orthodontic appliance (e.g. inner tray with activators), wherein the orthodontic appliance corresponds to one of the plurality of treatment stages, and wherein the geometry for the orthodontic appliance comprises a plurality of tooth-receiving cavities configured to receive the patient's teeth and exert tooth-moving forces thereon (see Fig. 1, via activators, and when combined with outer tray; see citations above and [0018]); determining a geometry for the attachable outer component (e.g. outer tray, attachable as described at [0021] see also [0012], and [0017]), shaping the attachable outer component based on the determined geometry for the attachable outer component to be secured to an exterior portion of the orthodontic appliance (as best understood by the Examiner, geometry thereof implicitly shapes appliance; as the tray is designed to fit over the inner component, the outer component is shaped by the geometry to be secured thereto, at least to some degree (for example at least due to flexibility of the material) or else it would not be possible to connect to the inner component; see [0021]), wherein the determined geometry of the attachable outer component comprises an exterior surface geometry indicative of the target arrangement for the patient's teeth (e.g. ideal arch form see [0011] and citations above), and wherein the attachable outer component covers the actual arrangement of the patient’s teeth when worn while maintaining the tooth moving forces exerted by the orthodontic appliance (e.g. outer component goes over the inner component and teeth allowing the forces to be applied while in use).
Schultz additionally discloses wherein the attachable outer component is shaped so as to provide a protective arrangement configured to reduce a force level provided to the patient, enhance dispersion of a localized impact force, or a combination thereof (implicitly due to the increased thickness of the combined device vs the thickness of just the inner tray; per claims 3 and 13); wherein the target arrangement corresponds to an intended outcome of a corresponding orthodontic treatment plan (e.g. desired outcome, see [0011]; per claims 5 and 15); wherein the target arrangement (ideal arch) comprises an intermediate target arrangement corresponding to a subsequent treatment stage relative to one of the stages ([0017] states that the ideal arch form can be further modified during treatment to add activators; as such the original “ideal” form is interpreted as the intermediate stage, and the then activated ideal form is interpreted as the final stage; per claims 6 and 16, see above); wherein determining the geometry for the attachable outer component comprises using a template of one or more predetermined dental arrangements corresponding to the intermediate target arrangement corresponding to the subsequent treatment stage relative to the one of the plurality of treatment stages (e.g. as best understood by the Examiner, at least in part since the shape of the activators are based on templates, which are interpreted as pre-determined dental arrangements since they are used on teeth(see [0019]) and outer shell is formed based on inner shell with activators; per claims 7 and 17); wherein the method/instructions further comprises iteratively evaluating the determined geometries of the orthodontic appliance and the attachable outer component, assessing whether structural requirements are satisfied by the determined geometries of the orthodontic appliance and the attachable outer component, and, if not, modifying the determined geometries of the orthodontic appliance and the attachable outer component (e.g. as explained above a series of outer components are designed and modeled, the use of each interpreted as a treatment stage; as each is designed and modeled in series, the method iteratively evaluates the determined geometries of the appliance and outer component; the structural requirements are assessed implicitly or else the forces could not be applied and the devices could not fit on the teeth; The Examiner notes that the practitioner accepting the geometry/treatment plan without modifications within the scope of the disclosure of Schultz (see above), and as such the Examiner interprets the method as not requiring the optional step of “modifying” since Schultz discloses that the structural geometries can be satisfied (accepted) without modification; per claims 8 and 18). Additionally, regarding claims 9 and 19, the optional modification step is not required/chosen in the interpretation of claims 8 and 18 as explained above, and claims 9 and 19 only further define the optional step, and as such the limitations directed thereto are not required in the instance where no modification is performed (encompassed by Schultz, see above).
Schultz does not teach generating a combined representation of the geometry for the appliance and attachable outer component as an integrated appliance (per claims 10 and 20), generating instructions for a dental appliance fabrication machine to fabricate the appliance and the attachable outer component, wherein the appliance and outer component are fabricated thereby, wherein generating the instructions comprise generating a first set of instructions for directly fabricating the appliance based on its determined geometry, and generating a second set of instructions for directly fabricating the attachable outer component based on its determined geometry (per claim 11), and wherein the outer component is shaped to mask the actual arrangement of the teeth when worn as required.
Phan, however, teaches applying color to orthodontic aligners to opacify them, thereby masking the patient’s teeth (see [0037]-[0039] and [0105]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the method/system of Schultz to include Phan’s coloring of the aligner, as such modification would improve the aesthetics of the device, helping to camouflage the aligner in the mouth of the user. It is noted that should Schultz' outer component and/or orthodontic appliance be modified with the step of coloring as taught by Phan, the outer component would mask the actual arrangement of the teeth either by the coloring of the outer component, or in combination with the coloring of the orthodontic appliance, meeting the limitations of the claims.
Wen, additionally, teaches forming an aligner of multiple attachable components by forming a combined/integrated digital model of the components (forming the integral device, per claims 10 and 20) and generating instructions for a dental appliance fabrication machine to fabricate all components of the orthodontic device, and wherein all components of the device are fabricated thereby (see abstract, [0028], [0030], [0060], [0069], [0071]; fabrication using fabrication machine implicitly requiring the use of instructions in order to function). Wen further discloses wherein generating the instructions comprise generating a first set of instructions for directly fabricating a first component based on its determined geometry and generating a second set of instructions for directly fabricating a second component based on the determined geometry thereof (see citations above, instructions are generated to form all components, per claim 11). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method/system of Schultz/Phan, as combined above, to include Wen’s teaching of generating instructions for and fabricating all components of an orthodontic device via a direct fabrication machine, as such modification would allow for more accurate and efficient treatment planning, allowing the entire volume, shape and/or size of the totality of the appliance to be considered, viewed and modeled, and would allow for faster and more efficient manufacturing of the components, making use of an old and well known manufacturing technique when forming a device from a digital model.
Claims 4 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schultz in view of Phan et al in view of Wen, as combined above, further in view of Bergersen (US 5645420).
Regarding claims 4 and 14, Schultz/Phan/Wen does not each wherein the geometry for the appliance is determined such that it comprises a reduced thickness towards a posterior portion of the appliance as required.
Bergersen, however, teaches an orthodontic treatment appliance (see Fig. 2) wherein the material thickness decreases toward the posterior portion of the mouth as required (see col 6, lines 63-67). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the method/system of Schultz/Phan/Wen to include Bergersen’s teaching of providing the device with a reduced thickness towards the posterior portion, as such modification would allow the device to treat and correct overbite more efficiently and prevent clenching and grinding (see Bergersen, col 6, lines 63-67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDWARD MORAN/Primary Examiner, Art Unit 3772