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
This action is in response to Applicant’s amendment filed 1/20/26.
Response to Arguments
Applicant's arguments filed 1/20/26 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 Applicants amendments.
Briefly, Applicant argues that Mason does not teach that the one or more protrusion features exerting a tooth moving force on a tooth as required. However, the Examiner disagrees, pointing to [0038] of Mason which explains an embodiment where the inner aligner has a bump or protrusion which engages an attachment feature applied to the teeth used to exert repositioning or orthodontic forces on the teeth. Then the outer component engages the bump or protrusion to secure the outer component thereto. As such the protrusions thereby exerting a tooth moving force on at least one of the teeth, at least indirectly via contact and/or coupling with the attachment features, meeting the limitations of the claims. Additional arguments against the dependent claims and associated combinations are based on the alleged deficiency of the base reference as explained above, and additionally have been further considered but are not persuasive for the same reasons as explained above.
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 9, the step of “modifying the 3D digital model” details a virtual step of adding protrusions into a determined space between virtual appliances. However, the newly added recitation recites a “exerting a tooth moving force on at least one tooth of the patient’s teeth” which as best understood refers to the physical models and should be clarified as such. Accordingly, as best understood by the Examiner the claim is interpreted such that the 3D digital models are modified to includes the at least one protrusion, such that when the first and second appliances are fabricated and worn the protrusion is configured to exert a tooth moving force on the teeth. Still further, the last paragraphs of the claims recite a choice of fabricating the first appliance, or the second appliance or both appliances; however, it is unclear how said function of exerting the tooth moving force on the teeth could be accomplished if only one of the appliances if fabricated. 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-3, 8-10, 15 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mason et al (US 2010/0129762 A1).
Regarding claims 2 and 9, Mason et al discloses a method of fabricating a dual orthodontic appliance assembly comprising a first orthodontic appliance and a second orthodontic appliance/ a system for fabricating a dual orthodontic assembly, the system comprising: one or more processors and a 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. digital method, and associated computer programming stored on computer, implicitly having a processor, for designing and fabricating dual component aligner with basic positioning appliance/main body and separate veneer portion; see Figs. 6-9 and [0040]-[0064]); generating, for each of the patient's teeth, a current 3D digital tooth model based at least in part on a current position of each of the patient's teeth (see step 210/220 and [0043]; “initial or current arrangement”); generating, for each of the patient's teeth, a target 3D digital tooth model based at least in part on a target position of each of the patient's teeth (see step 210 and [0043]; “planned final arrangement”); generating a 3D digital model of the first orthodontic appliance of the dual appliance assembly (e.g. model of main body portion/basic repositioning appliance, see [0060]); generating, for each of the patient's teeth, an offset 3D digital tooth model (offset model interpreted as combined representation of appliance minus the model of the basic positioning appliance (3D digital model), see [0050]-[0051]) based at least in part on the 3D digital model of the first orthodontic appliance (offset model based on removal of 3D digital model from dataset; and based on same initial data), wherein the offset 3D digital tooth model is based at least in part on the current 3D digital tooth model or target 3D digital tooth model modified to account for a thickness of the first orthodontic appliance (offset 3D digital model, resulting in veneer portion prior “further modification” (see [0060] and below) implicitly accounts for thickness of the first orthodontic assembly as it is attached thereto, and is formed to the desired thickness to form the planned and desired thickness for the device in entirety; see [0050]-[0051] cited above); generating a 3D digital model of the second orthodontic appliance based at least in part on the offset 3D tooth model (e.g. 3D digital model of veneer outer component after scaling (see [0050]-[0051]); determining a space between the 3D digital model of the first orthodontic appliance and the 3D digital model of the second orthodontic appliance (e.g. planning/generating the complementary snap fit features; female feature would comprise a space, see [0038]-[0039], [0060]-[0061]); modifying the 3D digital model of at least one of the first appliance or the second orthodontic appliance with one or more protrusion features (e.g. male feature of complementary features, see above) shaped and positioned to fill in at least a portion of the determine space to form one or more contact points between the first appliance and the second appliance, thereby exerting a tooth moving force on at least one tooth of the patient’s teeth (see [0038] and explanation below), wherein the shape and position of the one or more protrusion features is based at least in part on the determined space (e.g. space and protrusions are complementary and designed together, see citations above); and fabricating the first appliance based at least in part on the modified 3D digital model of the first appliance, or the second appliance based at least in part on the modified 3D digital model of the second orthodontic appliance, or both (see Fig. 6, step 270 and [0063]). The Examiner notes that Mason explains an embodiment where the inner aligner (first appliance) has a bump or protrusion which engages an attachment feature applied to the teeth used to exert repositioning or orthodontic forces on the teeth. The outer component (second appliance) engages the bump or protrusion to secure the outer component thereto. As such the protrusions thereby exert a tooth moving force on at least one of the teeth, at least indirectly via contact and/or coupling with the attachment features when the physical appliances are applied to the teeth meeting the limitations of the claims (see [0038]). Additionally as noted and cited above, Mason discloses virtual planning and design of the appliances and the associated protrusions/engagement features (see above).
Mason et al further discloses wherein the 3D digital tooth models are generated using a scanning system (see [0040]; per claims 3 and 10); wherein the method further comprising fabricating the first and/or second orthodontic appliance of the dual orthodontic appliance assembly based on one or more parameters of the 3D digital models (see [0063]; per claims 8 and 15); and filling the protrusion features with a filler material after fabrication (e.g. protrusions on first appliance are filled with material of attachment on tooth when placed and inserted thereon; and protrusion/recess of second appliance are filled with material of protrusion of first appliance when placed and inserted thereon; per claim 20).
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.
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) 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al.
Regarding claims 16-17, Mason et al discloses that the complementary snap features may be provided in a variety of sizes, including bump, hooks, ramps, undercuts, rivets, snaps, etc., and that some may be elongated to provide coupling with multiple aligners (see [0038]-[0039] and [0060]-[0061]), but does not explicitly teach wherein the protrusions have substantially the same dimensions along a width and length or have an unequal length and width as required. However, the Examiner notes that such modification would merely involve a change of shape and/or size of the complementary features as desired. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mason to include protrusions such that the length and width are either equal or unequal, as such modification would merely involve a change in shape and/or size of the protrusions, which has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(IV)(A)(B)). Further, the Examiner notes that selecting the length and width to be either equal or unequal merely encompasses the choosing from a finite number of identified predicable solutions with a reasonable expectation of success (e.g. length and width must either be the same or different), which has been held to be within the skill of the ordinary artisan (see MPEP 2143).
Regarding claims 18-19, as best understood by the Examiner, Mason et al discloses complementary features, but does not teach where the respective male and female features are located (e.g. male component on first or second appliance), and as such does not explicitly teach that a proximal end of the protrusions are recessed towards an inner tooth contacting surface of the first appliance (female portion in first appliance, extending inward to receive female component on second appliance), or wherein the protrusions are bulged towards an exterior surface of the first appliance (male portion in first appliance bulging outward to be received in female component in second aligner) as required. However, the Examiner notes that a male component must be fit to one of the first and second aligners, and the corresponding female component must be fit to the other of the first and second aligners. Accordingly, Mason either discloses the arrangement of claims 18-19, or alternatively, teaches the opposite arrangement. Further, arriving at such an arrangement would merely involve the reversal of known parts of the device which has been held to be within the skill of the ordinary artisan (e.g. reversing the locations of the male/female components of the complementary features). Still further, a bulge in the inner component that engages an attachment feature on the tooth would comprise a proximal end that is recessed toward the tooth (female interior) and bulged outward toward the exterior of the first appliance (e.g. male or convex exterior). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Mason to include the protrusions being recessed towards an inner tooth contacting surface of the first appliance or bulged towards an exterior surface of the first appliance, as such modification would merely involve a rearrangement of known parts of the device (e.g. the male and female components), which has been held to be within the skill of the ordinary artisan (see MPEP 2144.04(VI)(A)(B)).
Claim(s) 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al in view of Matov et al (US 2009/0191503 A1).
Regarding claims 4 and 11, Mason et al teaches wherein the 3D digital model of the second appliance may be modified repeatedly (see steps 240/250/260, Fig. 6), but does not specifically teaching applying a union Boolean operation to the offset 3D model as required.
Matov et al, however, teaches using Boolean addition (union) operations to modify a tooth data set as desired (see [0149]). 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 of Mason to include Matov’s use of Boolean addition, as such modification would allow the models to be optimized based on desired treatment goals (see Matov [0149]) and make use of an old and well-known technique to manipulate tooth model data.
Claim(s) 5-7 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al in view of Sachdeva et al (US 2004/0197727 A1).
Regarding the above claims, Mason et al suggests modifying the offset 3D digital model (see citations above), and wherein the modified models can be used to generate a jaw mold 3D model (e.g. model used to create physical mold for forming appliance, see [0063]-[0064]), but does not explicitly teach generating a 3D gingival model of the patient’s gingiva, combining the 3D gingival model and the offset model to generate the jaw mold 3D model, and fabricating the first and/or second appliance from the jaw mold 3D model as required.
Sachdeva et al, however, teaches providing/generating a 3D digital gum model (e.g., gum data set/scan data of gums), combining the gum model with a modified (offset) 3D model to form a composite model, and using the composite model for treatment planning (see [0053]). 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 of Mason to include Sachdeva’s teaching of generating and combining gum data (model) to produce a composite model, as such modification would provide for improved modeling of the entire oral anatomy and improved visualization of the digital models. It is noted that should the method of Mason be modified with the teachings of Sachdeva, as combined above, one of ordinary skill in the art would be motivated to modify the modified (offset) model of Mason to include the gingiva model, to generate a combined/modified model, which Mason discloses can be used to form a jaw mold model to form the first and/or second appliance (see citations above).
Conclusion
THIS ACTION IS MADE FINAL. 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 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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/EDWARD MORAN/Primary Examiner, Art Unit 3772