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 Arguments
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive. Applicant has argued that the prior art of Wen fails to provide for the new limitation of a gap formed between the lateral sides of the patient’s palate and an upper surface of the appliances, however the annotated image 31a in the following action shows that such a gap between an upper surface part of the shell is spaced apart as a gap from what would be a lateral side of the palate.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 2-5, 9-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wen et al. (WO 2006/096558 A2).
Regarding claims 2, 10, and 17, Wen discloses a method of expanding a patient’s palate according to a treatment plan by use of a series of palatal expanders (Fig. 10 all disclosing method steps of using a series of aligners to widen a jaw),
by placing a first orthodontic appliance of a shaped profile palatal expander that pushes directly against lateral sides of the patient's palate in the patient's mouth for a first period of time, wherein the first orthodontic appliance is configured to exert an amount of force to expand the palate according to a first stage of the treatment plan (Fig. 10 element 1070 and 1080, paragraph [00284] lines 5-7, paragraph [00286] lines disclosing “In general, the more lateral regions of the hard palate may be more easily moved than the upper (e.g., central) region of the hard palate. Thus, a lateral correction dental aligner may be configured to expand the palate from the regions closer to the teeth than the more central region” and thus the engagement and application of the lateral force directly to the lateral sides of the palate and not applying force to the upper/central region of the hard palate, Fig. 31a element 3109 contracting a lateral side of 3101), the first expander also having a first teeth engaging region and a second teeth engaging region configured to engage teeth on opposite sides of a patient's upper arch; and a transpalatal region extending between the first and second teeth engaging regions (Fig. 31a showing left and right teeth receiving regions 3107 and a transpalatal region 3109 between them)
and
placing a second orthodontic appliance that pushes directly against lateral sides of the patient's palate in the patient's mouth for a second period of time, wherein the second orthodontic appliance is configured to exert an amount of force to expand the palate according to a second stage of the treatment plan (Fig. 10 element 1090, 1095 disclosing the second aligner to move the teeth, paragraph [0283]-[0286] disclosing the lateral expansion of by the series of aligners with at least three and thus a second aligner),
wherein the first and second orthodontic appliances include a transpalatal region configured to form a gap between lateral side of the patient’s palate and an upper surface of the first and second orthodontic appliances (see annotated image 31a below),
wherein the second orthodontic appliance has a larger palatal width than the first orthodontic appliance (paragraph [00285] disclosing the series of aligners expand the palate to a final expanded with and thus the second appliance would have a larger palatal width than a first to cause the expansion at the second stage one the first stage expansion has completed), and
wherein the first and second orthodontic appliances are shaped to conform to the patient's upper arch and palate based on an oral scan of the patient (paragraph [00234] all disclosing the produced aligners are based on a scan of an impression of the patient’s arch and thus the shape would conform as shown in Fig. 31a).
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Regarding 3 and 20, Wen further discloses wherein the first orthodontic appliance and the second orthodontic appliance are each shaped with their transpalatal region to expand the palate according to a selected rate of palatial expansion (paragraph [00285] all disclosing the expansion is over a treatment time and number of steps thus giving a selected rate for each appliance shape).
Regarding claims 4, 12, and 18, Wen further discloses wherein the first and the second orthodontic appliances include a transpalatal region that extends between a first teeth engaging region and a second teeth engaging region without contacting a top of the patient's palate by having a gap therebetween (Fig. 31a showing portion of 3103 not being touched, paragraph [0065] the transpalatal region “contacts at least a portion of the upper pallet” and thus encompasses not contacting all of the upper palate, paragraphs [00284] and [00286], paragraph [00287] disclosing where transpalatal region can include holes or gaps exposing regions of the palate).
Regarding claim 5 and 13, Wen further discloses wherein the first and second orthodontic appliances further exert a force against the first and second teeth engaging regions (paragraph [0065]-[0066] disclosing the shape for providing the lateral force includes the shape delivering of lateral forces also to teeth, figs. 31a/b first and second teeth engaging regions 3107 on each side being structure determined in paragraph [00130] all the orthodontic appliance is digitally modeled with inner and our surfaces and segments to be used to make the physical appliance).
Regarding claims 9 and 14, Wen further discloses wherein the first orthodontic palatal expander appliance is shaped to provide a gap between the patient's palate and the first orthodontic appliance and the second orthodontic palatal expander appliance is shaped to provide a gap between the patient's palate and the second orthodontic appliance (paragraph [0065] the transpalatal region “contacts at least a portion of the upper pallet” and thus encompasses not contacting all of the upper palate, paragraphs [00284] and [00286], paragraph [00287] disclosing where transpalatal region can include holes or gaps exposing regions of the palate).
Regarding claims 11 and 21 wherein each successive palatal expander is based on a patient's treatment plan (paragraph [00285] all disclosing the expanders are based on a treatment plan of a series of treatment steps).
Regarding claims 15, 16, and 19, Wen further discloses wherein the first palatal expander and the second palatal expander are configured to attach to a temporary anchorage device affixed to the patient (Fig. 1a-1f showing various through holes to which the expanders can be attached to temporary anchorage device affixed to patent).
Further regarding claim 16, recitation of the temporary anchorage device is included in the oral scan of the patient, this limitation is being viewed as a product by process claim of merely reciting a process by which the product as discussed above was to be made, the presence of process limitations on product claims, which product does not otherwise patentably distinguish over prior art, cannot impart patentability to the product. In re Stephens 145 USPQ 656 (CCPA 1965).
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Wen et al. (WO 2006/096558 A2) in view of Kitching et al. (US 2016/0278882 A1).
Regarding claims 6 and 7, Wen discloses structure substantially identical to the instant application as discussed above but fails to explicitly disclose where the placing the first orthodontic appliance includes attaching the first orthodontic appliance to a temporary anchorage device that is fixed to the patient, nor where the temporary attachment device is attached to a bone of the patient, nor where the TAD is included in the oral scan of the patient.
However, Kitching discloses a method of applying series of orthodontic appliances to perform an orthodontic treatment using a series of shells (paragraph [0005] all disclosing a series of aligners to move teeth) where the method includes placing an appliance on a patient and also attaching the appliance to a temporary anchorage device that is attached to the bone of a patient (Fig. 3 elements 12 over which appliance 20 is attached, paragraph [0014] all disclosing the attachment is connected to bone structure) and that the TAD is present during the oral scan of the patient (paragraph [0035] all).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate placing the first orthodontic appliance to include attaching the first orthodontic appliance to a temporary anchorage device that is fixed to a bone of the patient that was included in the oral scanning of the patient as taught by Kitching into the method and oral scanning as taught by Wen for the purpose of providing for strengthening the appliance and to provide for support to the load that is at a location known in the scan data set as taught by Kitching (abstract and paragraph [0014] all, and [0035] disclosing the scanning data set would include the location of the TAD).
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 MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (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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/M.P.S/
Examiner, Art Unit 3772 09/10/2026
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772